Chapter 2100 Patentability

2101 [Reserved] 2121.03 Plant Genetics Ð What Constitutes -2102 Enabling Prior Art 2103 Patent Examination Process 2121.04 Apparatus and Articles Ð What 2104 Patentable Subject Matter Constitutes Enabling Prior Art 2105 Patentable Subject Matter Ð Living 2122 Discussion of Utility in the Prior Art Subject Matter 2123 Rejection Over Prior Art's Broad 2106 Patent Subject Matter Eligibility Disclosure Instead of Preferred 2106.01 [Reserved] Embodiments 2107 Guidelines for Examination of 2124 Exception to the Rule That the Critical Applications for Compliance with the Reference Date Must Precede the Filing Utility Requirement Date 2107.01 General Principles Governing Utility 2124.01 Tax Strategies Deemed Within the Rejections Prior Art 2107.02 Procedural Considerations Related to 2125 Drawings as Prior Art Rejections for Lack of Utility 2126 Availability of a Document as a 2107.03 Special Considerations for Asserted ªPatentº for Purposes of Rejection Therapeutic or Pharmacological Under 35 U.S.C. 102(a) or Pre-AIA 35 Utilities U.S.C. 102(a), (b), and (d) 2108 [Reserved] 2126.01 Date of Availability of a Patent as a -2110 Reference 2111 Claim Interpretation; Broadest 2126.02 Scope of Reference's Disclosure Reasonable Interpretation Which Can Be Used to Reject Claims 2111.01 Plain Meaning When the Reference Is a ªPatentº but 2111.02 Effect of Preamble Not a ªPublicationº 2111.03 Transitional Phrases 2127 Domestic and Foreign Patent 2111.04 ªAdapted to,º ªAdapted for,º Applications as Prior Art ªWherein,º and ªWherebyº Clauses 2128 ªPrinted Publicationsº as Prior Art 2111.05 Functional and Nonfunctional 2128.01 Level of Public Accessibility Descriptive Material Required 2112 Requirements of Rejection Based on 2128.02 Date Publication Is Available as a Inherency; Burden of Proof Reference 2112.01 Composition, Product, and Apparatus 2129 Admissions as Prior Art Claims 2130 [Reserved] 2112.02 Process Claims 2131 Anticipation Ð Application of 35 U.S.C. 2113 Product-by-Process Claims 102 2114 Apparatus and Article Claims Ð 2131.01 Multiple Reference 35 U.S.C. 102 Functional Language Rejections 2115 Material or Article Worked Upon by 2131.02 Genus-Species Situations Apparatus 2131.03 Anticipation of Ranges 2116 [Reserved] 2131.04 Secondary Considerations 2116.01 Novel, Unobvious Starting Material 2131.05 Nonanalogous or Disparaging Prior or End Product Art 2117 [Reserved] 2132 Pre-AIA 35 U.S.C. 102(a) -2120 2132.01 Publications as Pre-AIA 35 U.S.C. 2121 Prior Art; General Level of Operability 102(a) Prior Art Required to Make a Prima Facie Case 2133 Pre-AIA 35 U.S.C. 102(b) 2121.01 Use of Prior Art in Rejections Where 2133.01 Rejections of Continuation-In-Part Operability is in Question (CIP) Applications 2121.02 Compounds and Compositions Ð 2133.02 Rejections Based on Publications and What Constitutes Enabling Prior Art Patents

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2133.03 Rejections Based on ªPublic Useº or 2141 Examination Guidelines for ªOn Saleº Determining Obviousness Under 35 2133.03(a) ªPublic Useº U.S.C. 103 2133.03(b) ªOn Saleº 2141.01 Scope and Content of the Prior Art 2133.03(c) The ªInventionº 2141.01(a) Analogous and Nonanalogous Art 2133.03(d) ªIn This Countryº 2141.02 Differences Between Prior Art and 2133.03(e) Permitted Activity; Experimental Claimed Invention Use 2141.03 Level of Ordinary Skill in the Art 2133.03(e)(1) Commercial Exploitation 2142 Legal Concept of Prima Facie 2133.03(e)(2) Intent Obviousness 2133.03(e)(3) ªCompletenessº of the 2143 Examples of Basic Requirements of a Invention Prima Facie Case of Obviousness 2133.03(e)(4) Factors Indicative of an 2143.01 Suggestion or Motivation To Modify Experimental Purpose the References 2133.03(e)(5) Experimentation and Degree 2143.02 Reasonable Expectation of Success of Supervision and Control Is Required 2133.03(e)(6) Permitted Experimental 2143.03 All Claim Limitations Must Be Activity and Testing Considered 2133.03(e)(7) Activity of an Independent 2144 Supporting a Rejection Under 35 U.S.C. Third Party Inventor 103 2134 Pre-AIA 35 U.S.C. 102(c) 2144.01 Implicit Disclosure 2135 Pre-AIA 35 U.S.C. 102(d) 2144.02 Reliance on Scienti®c Theory 2135.01 The Four Requirements of Pre-AIA 2144.03 Reliance on Common Knowledge in 35 U.S.C. 102(d) the Art or ªWell Knownº Prior Art 2136 Pre-AIA 35 U.S.C. 102(e) 2144.04 Legal Precedent as Source of 2136.01 Status of U.S. Application as a Supporting Rationale Reference 2144.05 Obviousness of Ranges 2136.02 Content of the Prior Art Available 2144.06 Art Recognized Equivalence for the Against the Claims Same Purpose 2136.03 Critical Reference Date 2144.07 Art Recognized Suitability for an 2136.04 Different Inventive Entity; Meaning Intended Purpose of ªBy Anotherº 2144.08 Obviousness of Species When Prior 2136.05 Overcoming a Rejection Under Art Teaches Genus Pre-AIA 35 U.S.C. 102(e) 2144.09 Close Structural Similarity Between 2137 Pre-AIA 35 U.S.C. 102(f) Chemical Compounds (Homologs, 2137.01 Inventorship Analogues, Isomers) 2137.02 Applicability of Pre-AIA 35 U.S.C. 2145 Consideration of Applicant's Rebuttal 103(c) Arguments 2138 Pre-AIA 35 U.S.C. 102(g) 2146 Pre-AIA 35 U.S.C. 103(c) 2138.01 Interference Practice 2147 [Reserved] 2138.02 ªThe Invention Was Made in This -2149 Countryº 2150 Examination Guidelines for 35 U.S.C. 2138.03 ªBy Another Who Has Not 102 and 103 as Amended by the First Abandoned, Suppressed, or Inventor To File Provisions of the Concealed Itº Leahy-Smith America Invents Act 2138.04 ªConceptionº 2151 Overview of the Changes to 35 U.S.C. 2138.05 ªReduction to Practiceº 102 and 103 in the AIA 2138.06 ªReasonable Diligenceº 2152 Detailed Discussion of AIA 35 U.S.C. 2139 [Reserved] 102(a) and (b) -2140 2152.01 Effective Filing Date of the Claimed Invention

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2152.02 Prior Art Under AIA 35 U.S.C. Inventor-Originated Prior Public 102(a)(1) (Patented, Described in a Disclosure Exception) Printed Publication, or in Public Use, 2154.02(c) Prior Art Exception Under AIA on Sale, or Otherwise Available to the 35 U.S.C. 102(b)(2)(C) to AIA Public) 35 U.S.C. 102(a)(2) (Common 2152.02(a) Patented Ownership or Obligation of 2152.02(b) Described in a Printed Publication Assignment) 2152.02(c) In Public Use 2155 Use of Af®davits or Declarations Under 2152.02(d) On Sale 37 CFR 1.130 To Overcome Prior Art 2152.02(e) Otherwise Available to the Public Rejections 2152.02(f) No Requirement of "By Others" 2155.01 Showing That the Disclosure Was 2152.03 Admissions Made by the Inventor or a Joint 2152.04 The Meaning of "Disclosure" Inventor 2153 Prior Art Exceptions Under 35 U.S.C. 2155.02 Showing That the Subject Matter 102(b)(1) to AIA 35 U.S.C. 102(a)(1) Disclosed Had Been Previously 2153.01 Prior Art Exception Under AIA 35 Publicly Disclosed by the Inventor or U.S.C. 102(b)(1)(A) To AIA 35 a Joint Inventor U.S.C. 102(a)(1) (Grace Period 2155.03 Showing That the Disclosure was Inventor Or Inventor-Originated Made, or That Subject Matter had Disclosure Exception) Been Previously Publicly Disclosed, 2153.01(a) Grace Period Inventor Disclosure by Another Who Obtained the Subject Exception Matter Disclosed Directly or 2153.01(b) Grace Period Inventor-Originated Indirectly From the Inventor or a Joint Disclosure Exception Inventor 2153.02 Prior Art Exception Under AIA 35 2155.04 Enablement U.S.C. 102(b)(1)(B) to AIA 35 U.S.C. 2155.05 Who May File an Af®davit or 102(a)(1) (Inventor Or Declaration Under 37 CFR 1.130 Inventor-Originated Prior Public 2155.06 Situations in Which an Af®davit or Disclosure Exception) Declaration Is Not Available 2154 Provisions Pertaining to Subject Matter 2156 Joint Research Agreements in a U.S. Patent or Application 2157 Improper Naming of Inventors Effectively Filed Before the Effective 2158 AIA 35 U.S.C. 103 Filing Date of the Claimed Invention 2159 Applicability Date Provisions and 2154.01 Prior Art Under AIA 35 U.S.C. Determining Whether an Application 102(a)(2) ªU.S. Patent Documentsº Is Subject to the First Inventor To File 2154.01(a) WIPO Published Applications Provisions of the AIA 2154.01(b) Determining When Subject 2159.01 Applications Filed Before March 16, Matter Was Effectively Filed 2013 Under AIA 35 U.S.C. 102(d) 2159.02 Applications Filed on or After March 2154.01(c) Requirement Of ªNames Another 16, 2013 Inventorº 2159.03 Applications Subject to the AIA but 2154.02 Prior Art Exceptions Under 35 U.S.C. Also Containing a Claimed Invention 102(b)(2) to AIA 35 U.S.C. 102(a)(2) Having an Effective Filing Date 2154.02(a) Prior Art Exception Under AIA Before March 16, 2013 35 U.S.C. 102(b)(2)(A) to AIA 2159.04 Applicant Statement in Transition 35 U.S.C. 102(a)(2) Applications Containing a Claimed (Inventor-Originated Disclosure Invention Having an Effective Filing Exception) Date on or After March 16, 2013 2154.02(b) Prior Art Exception Under AIA 2160 [Reserved] 35 U.S.C. 102(b)(2)(B) to AIA 35 U.S.C. 102(a)(2) (Inventor or

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2161 Three Separate Requirements for 2164.06 Quantity of Experimentation Speci®cation Under 35 U.S.C. 112(a) or 2164.06(a) Examples of Enablement Pre-AIA 35 U.S.C. 112, First Paragraph Issues-Missing Information 2161.01 Computer Programming and 35 2164.06(b) Examples of Enablement Issues U.S.C. 112(a) or Pre-AIA 35 U.S.C. Ð Chemical Cases 112, First Paragraph 2164.06(c) Examples of Enablement Issues 2162 Policy Underlying 35 U.S.C. 112(a) or ± Computer Programming Cases Pre-AIA 35 U.S.C. 112, First Paragraph 2164.07 Relationship of Enablement 2163 Guidelines for the Examination of Requirement to Utility Requirement Patent Applications Under the 35 of 35 U.S.C. 101 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, 2164.08 Enablement Commensurate in Scope para. 1, ªWritten Descriptionº With the Claims Requirement 2164.08(a) Single Means Claim 2163.01 Support for the Claimed Subject 2164.08(b) Inoperative Subject Matter Matter in Disclosure 2164.08(c) Critical Feature Not Claimed 2163.02 Standard for Determining Compliance 2165 The Best Mode Requirement With the Written Description 2165.01 Considerations Relevant to Best Mode Requirement 2165.02 Best Mode Requirement Compared 2163.03 Typical Circumstances Where to Enablement Requirement Adequate Written Description Issue 2165.03 Requirements for Rejection for Lack Arises of Best Mode 2163.04 Burden on the Examiner with Regard 2165.04 Examples of Evidence of to the Written Description Concealment Requirement 2166 [Reserved] 2163.05 Changes to the Scope of Claims -2170 2163.06 Relationship of Written Description 2171 Two Separate Requirements for Claims Requirement to New Matter Under 35 U.S.C. 112 (b) or Pre-AIA 35 2163.07 Amendments to Application Which U.S.C. 112, Second Paragraph Are Supported in the Original 2172 Subject Matter Which the Inventor or Description a Joint Inventor Regards as The 2163.07(a) Inherent Function, Theory, or Invention Advantage 2172.01 Unclaimed Essential Matter 2163.07(b) Incorporation by Reference 2173 Claims Must Particularly Point Out 2164 The Enablement Requirement and Distinctly Claim the Invention 2164.01 Test of Enablement 2173.01 Interpreting the Claims 2164.01(a) Undue Experimentation Factors 2173.02 Determining Whether Claim 2164.01(b) How to Make the Claimed Language is De®nite Invention 2173.03 Correspondence Between 2164.01(c) How to Use the Claimed Speci®cation and Claims Invention 2173.04 Breadth Is Not Inde®niteness 2164.02 Working Example 2173.05 Speci®c Topics Related to Issues 2164.03 Relationship of Predictability of the Under 35 U.S.C. 112(b) or Pre-AIA Art and the Enablement Requirement 35 U.S.C. 112, Second Paragraph 2164.04 Burden on the Examiner Under the 2173.05(a) New Terminology Enablement Requirement 2173.05(b) Relative Terminology 2164.05 Determination of Enablement Based 2173.05(c) Numerical Ranges and Amounts on Evidence as a Whole Limitations 2164.05(a) Speci®cation Must Be Enabling 2173.05(d) Exemplary Claim Language (ªfor as of the Filing Date example,º ªsuch asº) 2164.05(b) Speci®cation Must Be Enabling 2173.05(e) Lack of Antecedent Basis to Persons Skilled in the Art

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2173.05(f) Reference to Limitations in -2102 [Reserved] Another Claim 2173.05(g) Functional Limitations 2173.05(h) Alternative Limitations 2103 Patent Examination Process 2173.05(i) Negative Limitations [R-07.2015] 2173.05(j) Old Combination 2173.05(k) Aggregation I. DETERMINE WHAT APPLICANT HAS 2173.05(l) [Reserved] INVENTED AND IS SEEKING TO PATENT 2173.05(m) Prolix 2173.05(n) Multiplicity It is essential that patent applicants obtain a prompt 2173.05(o) Double Inclusion yet complete examination of their applications. 2173.05(p) Claim Directed to Product-By- Under the principles of compact prosecution, each Process or Product and Process claim should be reviewed for compliance with every 2173.05(q) ªUseº Claims statutory requirement for patentability in the initial 2173.05(r) Omnibus Claim review of the application, even if one or more claims 2173.05(s) Reference to Figures or Tables are found to be de®cient with respect to some 2173.05(t) Chemical Formula statutory requirement. Thus, USPTO personnel 2173.05(u) Trademarks or Trade Names in a should state all reasons and bases for rejecting claims Claim in the ®rst Of®ce action. De®ciencies should be 2173.05(v) Mere Function of Machine explained clearly, particularly when they serve as a 2173.06 Practice Compact Prosecution basis for a rejection. Whenever practicable, USPTO 2174 Relationship Between the Requirements personnel should indicate how rejections may be of 35 U.S.C. 112(a) and (b) or Pre-AIA overcome and how problems may be resolved. A 35 U.S.C. 112, First and Second failure to follow this approach can lead to Paragraphs unnecessary delays in the prosecution of the 2175 [Reserved] application. -2180 2181 Identifying and Interpreting a 35 U.S.C. Prior to focusing on speci®c statutory requirements, 112(f) or Pre-AIA 35 U.S.C. 112, Sixth USPTO personnel must begin examination by Paragraph Limitation determining what, precisely, the applicant has 2182 Search and Identi®cation of the Prior invented and is seeking to patent, and how the claims Art relate to and de®ne that invention. USPTO personnel 2183 Making a Prima Facie Case of will review the complete speci®cation, including the Equivalence detailed description of the invention, any speci®c 2184 Determining Whether an Applicant Has embodiments that have been disclosed, the claims Met the Burden of Proving and any speci®c, substantial, and credible utilities Nonequivalence After a Prima Facie that have been asserted for the invention. Case Is Made 2185 Related Issues Under 35 U.S.C. 112(a) After obtaining an understanding of what applicant or (b) and Pre-AIA 35 U.S.C. 112, First invented, the examiner will conduct a search of the or Second Paragraphs prior art and determine whether the invention as 2186 Relationship to the Doctrine of claimed complies with all statutory requirements. Equivalents 2187 [Reserved] A. Identify and Understand Any Utility for the -2189 Invention 2190 Prosecution Laches 2101 The claimed invention as a whole must be useful. The purpose of this requirement is to limit patent protection to inventions that possess a certain level of ªreal worldº value, as opposed to subject matter

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that represents nothing more than an idea or concept, Patent applicants can assist the USPTO by preparing or is simply a starting point for future investigation applications that clearly set forth these aspects of an or research (Brenner v. Manson, 383 U.S. 519, invention. 528-36, 148 USPQ 689, 693-96 (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); C. Review the Claims In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d 1600, 1603-06 (Fed. Cir. 1993)). The claims de®ne the property rights provided by a patent, and thus require careful scrutiny. The goal USPTO personnel should review the application to of claim analysis is to identify the boundaries of the identify any asserted utility. The applicant is in the protection sought by the applicant and to understand best position to explain why an invention is believed how the claims relate to and de®ne what the useful. Accordingly, a complete disclosure should applicant has indicated is the invention. USPTO contain some indication of the practical application personnel must ®rst determine the scope of a claim for the claimed invention, i.e., why the applicant by thoroughly analyzing the language of the claim believes the claimed invention is useful. Such a before determining if the claim complies with each statement will usually explain the purpose of the statutory requirement for patentability. See In re invention or how the invention may be used (e.g., a Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, compound is believed to be useful in the treatment 1529 (Fed. Cir. 1998) (ª[T]he name of the game is of a particular disorder). Regardless of the form of the claim.º). statement of utility, it must enable one ordinarily skilled in the art to understand why the applicant USPTO personnel should begin claim analysis by believes the claimed invention is useful. See MPEP identifying and evaluating each claim limitation. For § 2107 for utility examination guidelines. An processes, the claim limitations will de®ne steps or applicant may assert more than one utility and acts to be performed. For products, the claim practical application, but only one is necessary. limitations will de®ne discrete physical structures Alternatively, an applicant may rely on the or materials. Product claims are claims that are contemporaneous art to provide that the claimed directed to either machines, manufactures or invention has a well-established utility. compositions of matter.

B. Review the Detailed Disclosure and Speci®c USPTO personnel are to correlate each claim Embodiments of the Invention To Understand What the limitation to all portions of the disclosure that Applicant Has Invented describe the claim limitation. This is to be done in all cases, regardless of whether the claimed invention The written description will provide the clearest is de®ned using means- (or step-) plus- function explanation of the applicant's invention, by language. The correlation step will ensure that exemplifying the invention, explaining how it relates USPTO personnel correctly interpret each claim to the prior art and explaining the relative limitation. signi®cance of various features of the invention. Accordingly, USPTO personnel should continue The subject matter of a properly construed claim is their evaluation by de®ned by the terms that limit its scope. It is this subject matter that must be examined. As a general (A) determining the function of the invention, matter, the grammar and intended meaning of terms that is, what the invention does when used as used in a claim will dictate whether the language disclosed (e.g., the functionality of a programmed limits the claim scope. Language that suggests or computer); and makes optional but does not require steps to be (B) determining the features necessary to performed or does not limit a claim to a particular accomplish at least one asserted practical application. structure does not limit the scope of a claim or claim limitation. The following are examples of language that may raise a question as to the limiting effect of the language in a claim:

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(A) statements of intended use or ®eld of use, patent protection under § 101, their claims must be (B) ªadapted toº or ªadapted forº clauses, considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to (C) "wherein" clauses, or ignore the presence of the old elements in the (D) ªwherebyº clauses. analysis. This is particularly true in a process claim because a new combination of steps in a process may This list of examples is not intended to be be patentable even though all the constituents of the exhaustive. The determination of whether particular combination were well known and in common use language is a limitation in a claim depends on the before the combination was made.º). speci®c facts of the case. See, e.g., Grif®n v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 II. CONDUCT A THOROUGH SEARCH OF THE (Fed. Cir. 2002)(®nding that a ªwhereinº clause PRIOR ART limited a process claim where the clause gave ªmeaning and purpose to the manipulative stepsº). Prior to evaluating the claimed invention under 35 See also MPEP §§ 2111.02 and 2111.04. U.S.C. 101, USPTO personnel are expected to conduct a thorough search of the prior art. Generally, USPTO personnel are to give claims their broadest a thorough search involves reviewing both U.S. and reasonable interpretation in light of the supporting foreign patents and nonpatent literature. In many disclosure. See MPEP § 2111. Disclosure may be cases, the result of such a search will contribute to express, implicit, or inherent. USPTO personnel are USPTO personnel's understanding of the invention. to give the claimed means- (or step-) plus- function Both claimed and unclaimed aspects of the invention limitations their broadest reasonable interpretation described in the speci®cation should be searched if consistent with all corresponding structures or there is a reasonable expectation that the unclaimed materials described in the speci®cation and their aspects may be later claimed. A search must take equivalents including the manner in which the into account any structure or material described in claimed functions are performed. See Kemco Sales, the speci®cation and its equivalents which Inc. v. Control Papers Company, Inc., 208 F.3d correspond to the claimed means- (or step-) plus- 1352, 54 USPQ2d 1308 (Fed. Cir. 2000). Further function limitation, in accordance with 35 U.S.C. guidance in interpreting the scope of equivalents is 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph provided in MPEP § 2181 through MPEP § 2186. and MPEP § 2181 through MPEP § 2186.

While it is appropriate to use the speci®cation to III. DETERMINE WHETHER THE CLAIMED determine what applicant intends a term to mean, a INVENTION COMPLIES WITH 35 U.S.C. 101 positive limitation from the speci®cation cannot be read into a claim that does not itself impose that A. Consider the Breadth of 35 U.S.C. 101 Under limitation. A broad interpretation of a claim by Controlling Law USPTO personnel will reduce the possibility that the claim, when issued, will be interpreted more Section 101 of title 35, United States Code, provides: broadly than is justi®ed or intended. An applicant can always amend a claim during prosecution to Whoever invents or discovers any new and better re¯ect the intended scope of the claim. useful process, machine, manufacture, or composition of matter, or any new and useful Finally, when evaluating the scope of a claim, every improvement thereof, may obtain a patent limitation in the claim must be considered. USPTO therefor, subject to the conditions and personnel may not dissect a claimed invention into requirements of this title. discrete elements and then evaluate the elements in isolation. Instead, the claim as a whole must be considered. See, e.g., Diamond v. Diehr, 450 U.S. 35 U.S.C. 101 de®nes four categories of inventions 175, 188-89, 209 USPQ 1, 9 (1981) (ªIn determining that Congress deemed to be the appropriate subject the eligibility of respondents' claimed process for matter of a patent: processes, machines, manufactures and compositions of matter. The latter

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three categories de®ne ªthingsº or ªproductsº while 1293, 101 USPQ2d 1961, 1965 (2012) (citing the ®rst category de®nes ªactionsº (i.e., inventions Gottschalk v. Benson, 409 U.S. 63, 67, 97, 175 that consist of a series of steps or acts to be USPQ 673, 675 (1972)). Thus, the courts have performed). See 35 U.S.C. 100(b) (ªThe term expressed concern that monopolizing these tools by `process' means process, art, or method, and includes granting patent rights may impede innovation rather a new use of a known process, machine, than promote it. See Alice Corp., 134 S. Ct. at 2354, manufacture, composition of matter, or material.º). 110 USPQ2d at 1980 (citing Mayo, 132 S. Ct. at 1293, 101 USPQ2d at 1965). However, the courts The subject matter which courts have found to be have carefully construed this "exclusionary principle outside of, or exceptions to, the four statutory lest it swallow all of patent law" because "all categories of invention is limited to abstract ideas, inventions at some level embody, use, re¯ect, rest laws of nature and natural phenomena (i.e., the upon, or apply laws of nature, natural phenomenon, judicial exceptions). Alice Corp. Pty. Ltd. v. CLS or abstract ideas." Alice, 134 S. Ct. at 2354, 110 Bank Int©l, 573 U.S. _, 134 S. Ct. 2347, 2354, 110 USPQ2d at 1980 (citing Mayo, 132 S. Ct. at 1293, USPQ2d 1976, 1980 (2014) (citing Association for 101 USPQ2d at 1965). Therefore, an invention is Molecular Pathology v. Myriad Genetics, Inc., 569 not considered to be ineligible for patent simply U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, because it involves a judicial exception. Alice, 134 1979 (2013)). See also Bilski v. Kappos, 561 S. Ct. at 2354, 110 USPQ2d at 1980-81 (citing U.S.593, 601, 130 S. Ct. 3218, 3225, 95 USPQ2d Diamond v. Diehr, 450 U.S. 174, 187 (1981)). 1001, 1005-06 (2010) (citing Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, The courts have held that an application of an 197 (1980)). abstract idea, law of nature or natural phenomenon "to a new and useful end" is eligible for patent The Supreme Court©s concern that drives this protection. Alice, 134 S. Ct. at 2354, 110 USPQ2d "exclusionary principle" is pre-emption. Alice Corp., at 1980 (citing Benson, 409 U.S. at 67, 175 USPQ 134 S. Ct. at 2354, 110 USPQ2d at 1980 (citing at 675). However, to transform an abstract idea, law Bilski, 561 U.S. at 611-612, 95 USPQ2d at 1010 of nature or natural phenomenon into "a ("upholding the patent ©would pre-empt use of this patent-eligible application", the claim must recite approach in all ®elds, and would effectively grant a more than simply the judicial exception "while monopoly over an abstract idea©"). The courts have adding the words ©apply it.©" Mayo, 132 S. Ct. at held that a claim may not preempt abstract ideas, 1294, 101 USPQ2d at 1965. Further, patent laws of nature, or natural phenomena, i.e., one may eligibility under 35 U.S.C. section 101 must not not patent every "substantial practical application" depend simply on the draftsman©s art. Alice, 134 S. of an abstract idea, law of nature, or natural Ct. at 2360, 110 USPQ2d at 1985 (citing Mayo 132 phenomenon. This is because such a patent would S. Ct. at 1294, 101 USPQ2d at 1966). "in practical effect be a patent on the [abstract idea, law of nature or natural phenomenon] itself." Determining whether an applicant is seeking to Gottschalk v. Benson, 409 U.S. 63, 71, 72, 175 patent a judicial exception, namely an abstract idea, USPQ 673, 676 (1972). The concern over a law of nature or a natural phenomenon, or a preemption was expressed as early as 1852. See Le patent-eligible application of the judicial exception Roy v. Tatham, 55 U.S. 156, 175 (1852) (ªA has proven to be challenging. The Supreme Court principle, in the abstract, is a fundamental truth; an in Mayo Collaborative Serv. v. Prometheus Labs., original cause; a motive; these cannot be patented, Inc., 566 U.S. _, 132 S. Ct. 1289, 1301, 101 USPQ2d as no one can claim in either of them an exclusive 1961, 1966 (2013) laid out a framework for making right.º). this determination. See also Alice, 134 S. Ct. at 2355, 110 USPQ2d at 1981. This framework, which Abstract ideas, laws of nature, and natural is referred to as the Mayo test, is discussed in further phenomenon "are the basic tools of scienti®c and detail in MPEP § 2106. The ®rst part of the test is technological work." Mayo Collaborative Serv. v. to determine whether the claims are directed to an Prometheus Labs., Inc., 566 U.S. _, 132 S. Ct. 1289, abstract idea, a law of nature or a natural

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phenomenon (i.e., a judicial exception). If the claims 35 U.S.C. 102, and 35 U.S.C. 103, and should avoid are directed to a judicial exception, the second part treating an application solely on the basis of of the test is to determine when the claim recites patent-eligibility under 35 U.S.C. 101 except in the additional elements that amount to signi®cantly more most extreme cases. than the judicial exception. The Supreme Court has described the second part of the test as the "search See MPEP § 2106 for determining whether a claim for an ©inventive concept©". Alice, 134 S. Ct. at 2355, is directed to patent-eligible subject matter. 110 USPQ2d at 1981 (citing Mayo 132 S. Ct. at 1294, 101 USPQ2d at 1966). See MPEP § 2107 for a detailed discussion of utility, which is a separate requirement from eligibility The Supreme Court in Bilski v. Kappos, 561 U.S. under 35 U.S.C. 101, and requires that inventions 593, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010), made be useful or have a utility that is speci®c, substantial clear that business methods are not "categorically and credible. outside of § 101's scope," stating that "a business method is simply one kind of `method' that is, at IV. EVALUATE APPLICATION FOR least in some circumstances, eligible for patenting COMPLIANCE WITH 35 U.S.C. 112 under § 101." Thus, examiners are reminded that software and business methods are not excluded A. Determine Whether the Claimed Invention Complies categories of subject matter. For example, software with 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second is not automatically an abstract idea. While some Paragraph Requirements software may include an abstract idea (such as a step that employs a mathematical relationship), further 35 U.S.C. 112(b) and the second paragraph of analysis of the claim as a whole would be required pre-AIA 35 U.S.C. 112 contains two separate and to determine eligibility. distinct requirements: (A) that the claim(s) set forth the subject matter applicants regard as the invention, In addition, examiners are reminded that 35 U.S.C. and (B) that the claim(s) particularly point out and 101 is not the sole tool for determining patentability; distinctly claim the invention. An application will where a claim encompasses an abstract idea, law of be de®cient under the ®rst requirement of 35 U.S.C. nature, or natural phenomenon, 35 U.S.C. 112 , 35 112(b) or pre-AIA 35 U.S.C. 112, second paragraph U.S.C. 102 , and 35 U.S.C. 103 will provide when evidence including admissions, other than in additional tools for ensuring that the claim meets the the application as ®led, shows that an applicant has conditions for patentability. As the Supreme Court stated what he or she regards the invention to be made clear in Bilski: different from what is claimed (see MPEP § 2171 - MPEP § 2172.01). The § 101 patent-eligibility inquiry is only a threshold test. Even if an invention quali®es as An application fails to comply with the second a process, machine, manufacture, or requirement of 35 U.S.C. 112(b) or pre-AIA 35 composition of matter, in order to receive the U.S.C. 112, second paragraph when the claims do Patent Act's protection the claimed invention not set out and de®ne the invention with a reasonable must also satisfy ``the conditions and degree of precision and particularity. In this regard, requirements of this title.'' § 101. Those the de®niteness of the language must be analyzed, requirements include that the invention be not in a vacuum, but always in light of the teachings novel, see § 102, nonobvious, see § 103, and of the disclosure as it would be interpreted by one fully and particularly described, see § 112. of ordinary skill in the art. Applicant's claims, interpreted in light of the disclosure, must reasonably apprise a person of ordinary skill in the art of the Therefore, examiners should avoid focusing on invention. issues of patent-eligibility under 35 U.S.C. 101 to the detriment of considering an application for The scope of a ªmeansº limitation is de®ned as the compliance with the requirements of 35 U.S.C. 112, corresponding structure or material set forth by the

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inventor in the written description and equivalents (1) at the time the application was ®led, did the thereof that perform the claimed function. See MPEP inventor possess a best mode for practicing the § 2181 through MPEP § 2186. See MPEP § 2173 et invention; and seq. for a discussion of a variety of issues pertaining (2) if the inventor did possess a best mode, does to the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, the written description disclose the best mode such second paragraph requirement that the claims that a person skilled in the art could practice it. particularly point out and distinctly claim the invention. See MPEP § 2165 et seq. for additional guidance. De®ciencies related to disclosure of the best mode B. Determine Whether the Claimed Invention Complies for carrying out the claimed invention are not usually with 35 U.S.C. 112(a) or 35 U.S.C. 112, First Paragraph encountered during examination of an application Requirements because evidence to support such a de®ciency is seldom in the record. Fonar Corp. v. General Elec. 35 U.S.C. 112(a) and the ®rst paragraph of pre-AIA Co., 107 F.3d 1543, 1548-49, 41 USPQ2d at 35 U.S.C. 112 contain three separate and distinct 1804-05. requirements: V. DETERMINE WHETHER THE CLAIMED (A) adequate written description, INVENTION COMPLIES WITH 35 U.S.C. 102 AND 103 (B) enablement, and (C) best mode. Reviewing a claimed invention for compliance with 35 U.S.C. 102 and 35 U.S.C.103 begins with a 1. Adequate Written Description comparison of the claimed subject matter to what is known in the prior art. See MPEP § 2131 - MPEP For the written description requirement, an § 2146 and for speci®c guidance on patentability applicant's speci®cation must reasonably convey to determinations under 35 U.S.C. 102 and 35 U.S.C. those skilled in the art that the applicant was in 103. If no differences are found between the claimed possession of the claimed invention as of the date invention and the prior art, then the claimed of invention. See MPEP § 2163 for further guidance invention lacks novelty and is to be rejected by with respect to the evaluation of a patent application USPTO personnel under 35 U.S.C. 102. Once for compliance with the written description differences are identi®ed between the claimed requirement. invention and the prior art, those differences must be assessed and resolved in light of the knowledge 2. Enabling Disclosure possessed by a person of ordinary skill in the art. Against this backdrop, one must determine whether An applicant's speci®cation must enable a person the invention would have been obvious. If not, the skilled in the art to make and use the claimed claimed invention satis®es 35 U.S.C. 103. invention without undue experimentation. The fact that experimentation is complex, however, will not VI. CLEARLY COMMUNICATE FINDINGS, make it undue if a person of skill in the art typically CONCLUSIONS AND THEIR BASES engages in such complex experimentation. Once USPTO personnel have concluded the above See MPEP § 2164 et seq. for detailed guidance with analyses of the claimed invention under all the regard to the enablement requirement of 35 U.S.C. statutory provisions, including 35 U.S.C. 101, 35 112(a) and pre-AIA 35 U.S.C. 112, ®rst paragraph. U.S.C. 112, 35 U.S.C. 102, and 35 U.S.C. 103, they should review all the proposed rejections and their 3. Best Mode bases to con®rm that they are able to set forth a prima facie case of unpatentability. Only then Determining compliance with the best mode should any rejection be imposed in an Of®ce action. requirement requires a two-prong inquiry: The Of®ce action should clearly communicate the

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®ndings, conclusions and reasons which support MPEP § 2107 for a detailed discussion of the utility them. requirement.

2104 Patentable Subject Matter [R-07.2015] 2105 Patentable Subject Matter Ð Living Subject Matter [R-07.2015] 35 U.S.C. 101 Inventions patentable

Whoever invents or discovers any new and useful process, I. INTRODUCTION machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefor, The decision of the Supreme Court in Diamond v. subject to the conditions and requirements of this title. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held that microorganisms produced by genetic 35 U.S.C. 101 has been interpreted as imposing four engineering are not excluded from patent protection requirements. by 35 U.S.C. 101. It is clear from Chakrabarty and subsequent judicial decisions that the question of First, whoever invents or discovers an eligible whether or not an invention embraces living matter invention may obtain only ONE patent therefor. This is irrelevant to the issue of patentability. Note, requirement forms the basis for statutory double however, that Congress has excluded claims directed patenting rejections when two applications claim the to or encompassing a human organism from same invention, i.e. claim identical subject matter. patentability. See The Leahy-Smith America Invents See MPEP § 804 for a full discussion of the Act (AIA), Pub. L. 112-29, sec. 33(a), 125 Stat. 284 prohibition against double patenting. (September 16, 2011).

Second, the inventor(s) must be the applicant in an II. LIVING SUBJECT MATTER MAY BE application ®led before September 16, 2012, (except PATENTABLE as otherwise provided in pre-AIA 37 CFR 1.41(b)) and the inventor or each joint inventor must be A. Living Subject Matter May Be Directed To A identi®ed in an application ®led on or after Statutory Category September 16, 2012. See MPEP § 2137.01 for a detailed discussion of inventorship, MPEP § In Chakrabarty, the Supreme Court held that a claim 602.01(c) et seq. for details regarding correction of to a genetically engineered bacterium was directed inventorship, and MPEP § 706.03(a), subsection IV, to at least one of the four statutory categories, for rejections under 35 U.S.C. 101 and 115 (and because the bacterium was a ªmanufactureº and/or pre-AIA 35 U.S.C. 102(f) for applications subject a ªcomposition of matter.º to pre-AIA 35 U.S.C. 102) for failure to set forth the correct inventorship). The Supreme Court made the following points in the Chakrabarty opinion: Third, a claimed invention must fall within one of the four eligible categories of invention, i.e., process, 1. ªGuided by these canons of construction, machine, manufacture, or composition of matter, as this Court has read the term `manufacture' in these categories have been interpreted by the courts. § 101 in accordance with its dictionary See MPEP § 2106 for a detailed discussion of the de®nition to mean `the production of articles subject matter eligibility requirements and MPEP § for use from raw or prepared materials by 2105 for special considerations for living subject giving to these materials new forms, qualities, matter. properties, or combinations, whether by hand-labor or by machinery.'º Fourth, a claimed invention must be useful or have 2. ªIn choosing such expansive terms as a utility that is speci®c, substantial and credible. See `manufacture' and `composition of matter,' modi®ed by the comprehensive `any,' Congress

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plainly contemplated that the patent laws would With respect to plant subject matter, the Supreme be given wide scope.º Court held that patentable subject matter under 35 3. ªThe Act embodied Jefferson's philosophy U.S.C. 101 includes newly developed plant breeds, that `ingenuity should receive a liberal even though plant protection is also available under encouragement.' 5 Writings of Thomas the Plant Patent Act (35 U.S.C. 161 - 164) and the Jefferson, 75-76 Washintgon ed. 1871). See Plant Variety Protection Act (7 U.S.C. 2321 et. Graham v . John Deere Co., 383 U.S. 1, 7-10, seq.). J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred 148 USPQ459, 462-464 (1966). Subsequent Int' l, Inc., 534 U.S. 124, 143-46, 122 S.Ct. 593, patent statutes in 1836, 1870, and 1874 605-06, 60 USPQ2d 1865, 1874 (2001) (The scope employed this same broad language. In 1952, of coverage of 35 U.S.C. 101 is not limited by the when the patent laws were recodi®ed, Congress Plant Patent Act or the Plant Variety Protection Act; replaced the word `art' with `process,' but each statute can be regarded as effective because of otherwise left Jefferson's language intact. The its different requirements and protections). In Committee Reports accompanying the 1952 analyzing the history of the Plant Patent Act of 1930 act inform us that Congress intended statutory in Chakrabarty, the Court stated: ªIn enacting the subject matter to `include any thing under the Plant Patent Act, Congress addressed both of these sun that is made by man.' S. Rep. No. 1979, concerns [the concern that plants, even those 82d Cong., 2d Sess., 5 (1952); H. R. Rep. No. arti®cially bred, were products of nature for purposes 1923, 82d Cong., 2d Sess., 6 (1952)º of the patent law and the concern that plants were 4. ªCongress thus recognized that the relevant thought not amenable to the written description distinction was not between living and requirements of the patent law]. It explained at length inanimate things, but between products of its belief that the work of the plant breeder `in aid nature, whether living or not, and human-made of nature' was patentable invention. S. Rep. No. 315, inventions. Here, respondent's microorganism 71st Cong., 2d Sess., 6-8 (1930); H.R. Rep. No. is the result of human ingenuity and research.º 1129, 71st Cong., 2d Sess., 7-9 (1930).º See also Ex parte Hibberd, 227 USPQ 443 (Bd. Pat. App. & Inter. 1985), wherein the Board held that plant A review of these statements as well as the whole subject matter may be the proper subject of a patent Chakrabarty opinion reveals that the Court did not under 35 U.S.C. 101 even though such subject matter limit its decision to genetically engineered living may be protected under the Plant Patent Act or the organisms, and that the Court enunciated a very Plant Variety Protection Act. broad interpretation of ªmanufactureº and ªcomposition of matterº in 35 U.S.C. 101. See MPEP § 2106, subsection I, for a discussion of the categories of statutory subject matter. Following the reasoning in Chakrabarty, the Board of Patent Appeals and Interferences determined that B. Living Subject Matter May Be Eligible for Patent animals are patentable subject matter under 35 Protection U.S.C. 101. In Ex parte Allen, 2 USPQ2d 1425 (Bd. Pat. App. & Inter. 1987), the Board decided that a The Supreme Court in Chakrabarty held a claim to polyploid Paci®c coast oyster could have been the a genetically engineered bacterium eligible, because proper subject of a patent under 35 U.S.C. 101 if all the claimed bacterium was not a ªproduct of natureº the criteria for patentability were satis®ed. Shortly exception. In so holding, the Court made the after the Allen decision, the Commissioner of following points: Patents and Trademarks issued a notice (Animals - Patentability, 1077 O.G. 24, April 21, 1987) that the Patent and Trademark Of®ce would now consider 1. ªThis is not to suggest that § 101 has no nonnaturally occurring, nonhuman multicellular limits or that it embraces every discovery. The living organisms, including animals, to be patentable laws of nature, physical phenomena, and subject matter within the scope of 35 U.S.C. 101. abstract ideas have been held not patentable.º 2. ªThus, a new mineral discovered in the earth or a new plant found in the wild is not

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patentable subject matter. Likewise, Einstein Of®ce personnel are to consult the 2014 Interim 2 Guidance on Patent Subject Matter Eligibility, 79 could not patent his celebrated law that E=mc ; Fed. Reg. 74618 (December 16, 2014) and related nor could Newton have patented the law of materials available at www.uspto.gov/patent/ gravity.º laws-and-regulations/examination-policy/2014-interim- 3. ªHis claim is not to a hitherto unknown guidance-subject-matter-eligibility-0 to determine natural phenomenon, but to a nonnaturally whether a nature-based product such as living subject occurring manufacture or composition of matter matter is eligible for patent protection. See also - a product of human ingenuity `having a MPEP § 2106, subsection II. distinctive name, character [and] use.'º 4. After reference to Funk Seed Co. & Kalo III. HUMAN ORGANISMS ARE NONSTATUTORY Co., 333 U.S. 127, 76 USPQ 280 (1948), ªHere, SUBJECT MATTER by contrast, the patentee has produced a new bacterium with markedly different Congress has excluded claims directed to or characteristics from any found in nature and encompassing a human organism from patentability. one having the potential for signi®cant utility. The Leahy-Smith America Invents Act (AIA), Public His discovery is not nature's handiwork, but Law 112-29, sec. 33(a), 125 Stat. 284, states: his own; accordingly it is patentable subject matter under § 101.º Notwithstanding any other provision of law, no patent may issue on a claim directed to or A review of these statements as well as the whole encompassing a human organism. Chakrabarty opinion reveals that ªlaws of nature, physical phenomena and abstract ideasº are not patentable subject matter. See MPEP § 2106, The legislative history of the AIA includes the subsection II, for a discussion of the judicial following statement, which sheds light on the exceptions. meaning of this provision:

A more recent judicial decision from the Federal [T]he U.S. Patent Of®ce has already issued Circuit indicated that ªdiscoveries that possess patents on genes, stems cells, animals with `markedly different characteristics from any found human genes, and a host of non-biologic in nature,' ¼ are eligible for patent protection.º In products used by humans, but it has not issued re Roslin Institute (Edinburgh), 750 F.3d 1333, 1336, patents on claims directed to human organisms, 110 USPQ2d 1668, 1671 (Fed. Cir. 2014), quoting including human embryos and fetuses. My Chakrabarty, 447 U.S. at 310. In Roslin, the amendment would not affect the former, but claimed invention was a live-born clone of a would simply af®rm the latter. pre-existing, non-embryonic, donor mammal selected from cattle, sheep, pigs, and goats. An embodiment 157 Cong. Rec. E1177-04 (testimony of of the claimed invention was the famous Dolly the Representative Dave Weldon previously presented Sheep, which the court stated was ªthe ®rst mammal in connection with the Consolidated Appropriations ever cloned from an adult somatic cell.º Despite Act, 2004, Public Law 108-199, 634, 118 Stat. 3, acknowledging that the method used to create the 101, and later resubmitted with regard to the AIA; claimed clones ªconstituted a breakthrough in see 149 Cong. Rec. E2417-01). Thus, section 33(a) scienti®c discoveryº, the court held the claims of the AIA codi®es existing Of®ce policy that human ineligible because ªDolly herself is an exact genetic organisms are not patent-eligible subject matter. replica of another sheep and does not possess `markedly different characteristics from any [farm If the broadest reasonable interpretation of the animals] found in nature.'º Roslin, 750 F.3d at 1337, claimed invention as a whole encompasses a human 110 USPQ2d at 1671. organism, then a rejection under 35 U.S.C. 101 and AIA sec. 33(a) must be made indicating that the claimed invention is directed to a human organism

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and is therefore nonstatutory subject matter. Form ii. Machine ± a concrete thing, consisting of paragraph 7.04.03 should be used; see MPEP § parts, or of certain devices and combination of 706.03(a). Furthermore, the claimed invention must devices. Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570, be examined with regard to all issues pertinent to 17 L. Ed. 650 (1863). This includes every patentability, and any applicable rejections under 35 mechanical device or combination of mechanical U.S.C. 102, 103, or 112 must also be made. powers and devices to perform some function and produce a certain effect or result. Corning v. Burden, 2106 Patent Subject Matter Eligibility 56 U.S. 252, 267, 14 L. Ed. 683 (1854). [R-07.2015] iii. Manufacture ± an article produced from raw or prepared materials by giving to these materials There are two criteria for determining subject matter new forms, qualities, properties, or combinations, eligibility under 35 U.S.C. 101 and both must be whether by hand labor or by machinery. Diamond satis®ed. The claimed invention (1) must be directed v. Chakrabarty, 447 U.S. 303, 308, 206 USPQ 193, to one of the four statutory categories, and (2) must 197 (1980) (emphasis added) (quoting Am. Fruit not be wholly directed to subject matter Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11, 51 S. encompassing a judicially recognized exception, as Ct. 328, 75 L. Ed. 801, 1931 (Dec. Comm©r Pat. 711 de®ned below. The following two step analysis is (1931))). used to evaluate these criteria. iv. Composition of matter ± all compositions of two or more substances and all composite articles, I. THE FOUR CATEGORIES OF STATUTORY whether they be the results of chemical union, or of SUBJECT MATTER mechanical mixture, or whether they be gases, ¯uids, powders or solids, for example. Chakrabarty, 447 Step 1: Is the claim directed to one of the four U.S. at 308, 206 USPQ at 197. patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? Non-limiting examples of claims that are not directed The subject matter of the claim must be directed to to one of the statutory categories: one of the four subject matter categories. If it is not, the claim is not eligible for patent protection and i. transitory forms of signal transmission (for should be rejected under 35 U.S.C. 101, for at least example, a propagating electrical or electromagnetic this reason. A summary of the four categories of signal per se), In re Nuijten, 500 F.3d 1346, 1357, invention, as they have been de®ned by the courts, 84 USPQ2d 1495, 1503 (Fed. Cir. 2007); are: ii. a human per se, The Leahy-Smith America Invents Act (AIA), Public Law 112-29, sec. 33, 125 i. Process ± an act, or a series of acts or steps. Stat. 284 (September 16, 2011); See Gottschalk v. Benson, 409 U.S. 63, 70, 175 iii. a legal contractual agreement between two USPQ 673, 676 (1972) ("A process is a mode of parties, see In re Ferguson, 558 F.3d 1359, 1364, treatment of certain materials to produce a given 90 USPQ2d 1035, 1039-40 (Fed. Cir. 2009) (cert. result. It is an act, or a series of acts, performed denied); upon the subject-matter to be transformed and reduced to a different state or thing." (emphasis iv. a computer program per se, Gottschalk v. added) (quoting Cochrane v. Deener, 94 U.S. 780, Benson, 409 U.S. at 72, 175 USPQ at 676-77; 788, 24 L. Ed. 139, 1877 Dec. Comm©r Pat. 242 v. a company, Ferguson, 558 F.3d at 1366, 90 (1876))); NTP, Inc. v. Research in Motion, Ltd., 418 USPQ at 1040; F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of acts." (quoting vi. a mere arrangement of printed matter, In re Minton v. Natl. Ass'n. of Securities Dealers, 336 Miller, 418 F.2d 1392, 1396, 164 USPQ 46, 49 F.3d 1373, 336 F.3d 1373, 1378, 67 USPQ2d 1614, (CCPA 1969); and 1681 (Fed. Cir. 2003))). See also 35 U.S.C. 100(b); vii. data per se, Digitech Image Tech., LLC v. Bilski v. Kappos, 561 U.S. 593, 130 S. Ct. 3218, 95 Electronics for Imaging, Inc., 758 F.3d 1344, 1350, USPQ2d 1001 (2010). 111 USPQ2d 1717, 1720 (Fed. Cir. 2014).

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A claim that covers both statutory and non-statutory 3225, 95 USPQ2d 1001, 1005-06 (2010) (stating embodiments (under the broadest reasonable ªThe Court©s precedents provide three speci®c interpretation of the claim when read in light of the exceptions to § 101©s broad patent-eligibility speci®cation and in view of one skilled in the art) principles: `laws of nature, physical phenomena, and embraces subject matter that is not eligible for patent abstract ideas.'º) (quoting Diamond v. Chakrabarty, protection and therefore is directed to non-statutory 447 U.S. 303, 309, 206 USPQ 193, 197 (1980)). subject matter. Such claims fail the ®rst step (Step 1: NO) and should be rejected under 35 U.S.C. 101, Determining that a claim falls within one of the four for at least this reason. enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, For example, machine readable media can manufacture, or composition of matter) does not end encompass non-statutory transitory forms of signal the eligibility analysis because claims directed to transmission, such as, a propagating electrical or nothing more than abstract ideas (such as electromagnetic signal per se. See In re Nuijten, mathematical algorithms), natural phenomena, and 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). laws of nature are not eligible for patent protection. When the broadest reasonable interpretation of Diamond v. Diehr, 450 U.S. 175, 185, 209 USPQ machine readable media in light of the speci®cation 1, 7 (1981); accord, e.g., Chakrabarty, 447 U.S. at as it would be interpreted by one of ordinary skill in 309, 206 USPQ at 197; Parker v. Flook, 437 U.S. the art encompasses transitory forms of signal 584, 589, 198 USPQ 193, 197 (1978); Benson, 409 transmission, a rejection under 35 U.S.C. 101 as U.S. at 67-68 , 175 USPQ at 675. failing to claim statutory subject matter would be appropriate. Thus, a claim to a computer readable In addition to the terms "laws of nature," "natural medium that can be a compact disc or a carrier wave phenomena," and "abstract ideas," judicially covers a non-statutory embodiment and therefore recognized exceptions have been described using should be rejected under 35 U.S.C. 101 as being various other terms, including "physical directed to non-statutory subject matter. phenomena," "scienti®c principles," "systems that depend on human intelligence alone," "disembodied If the claimed invention is clearly not within one of concepts," "mental processes" and "disembodied the four categories, then a rejection under 35 U.S.C. mathematical algorithms and formulas," for example. 101 must be made indicating that the claimed The exceptions re¯ect the courts' view that the basic invention is directed to non-statutory subject matter. tools of scienti®c and technological work are not Form paragraphs 7.05 and 7.05.01 should be used; patentable. ªA principle, in the abstract, is a see MPEP § 706.03(a). However, when the claim fundamental truth; an original cause; a motive; these fails under Step 1 and it appears from applicant's cannot be patented, as no one can claim in either of disclosure that the claim could be amended to be them an exclusive right.º Le Roy v. Tatham,55 U.S. directed to a statutory category, Step 2 below should (14 How.) 156, 175 (1852). Instead, such still be conducted. ªmanifestations of laws of natureº are ªpart of the storehouse of knowledge,º ªfree to all men and II. JUDICIAL EXCEPTIONS TO THE FOUR reserved exclusively to none.º Funk Bros. Seed Co. CATEGORIES v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Step 2: Does the claim wholly embrace a judicially recognized exception, which includes laws of nature, Thus, ªa new mineral discovered in the earth or a natural phenomena, and abstract ideas? Alice Corp. new plant found in the wild is not patentable subject Pty. Ltd. v. CLS Bank Int©l, 573 U.S. _, 134 S. Ct. matterº under Section 101. Chakrabarty, 447 U.S. 2347, 2354, 110 USPQ2d 1976, 1980 (2014) (citing at 309, 206 USPQ at 197. ªLikewise, Einstein could Association for Molecular Pathology v. Myriad not patent his celebrated law that E=mc2; nor could Genetics, Inc. 569 U.S. _, 133 S. Ct. 2107, 2116, Newton have patented the law of gravity.º Id. Nor 106 USPQ2d 1972, 1979 (2013)). See also See can one patent ªa novel and useful mathematical Bilski v. Kappos, 561 U.S.593, 601, 130 S. Ct. 3218, formula,º Flook, 437 U.S. at 585, 198 USPQ at 195;

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electromagnetism or steam power, O'Reilly v. or within one of the exceptions to statutory subject Morse, 56 U.S. (15 How.) 62, 113-114 (1853); or matter. ªThe examiner bears the initial burden ¼ of ª[t]he qualities of ... bacteria, ... the heat of the sun, presenting a prima facie case of unpatentability.º electricity, or the qualities of metals,º Funk, 333 In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d U.S. at 130, 76 USPQ at 281; see Le Roy, 55 U.S. 1443, 1444 (Fed. Cir. 1992). If the record as a whole (14 How.) at 175. suggests that it is more likely than not that the claimed invention would be considered signi®cantly Analysis Of Subject Matter Eligibility more than an abstract idea, natural phenomenon, or law of nature, then USPTO personnel should not While abstract ideas, natural phenomena, and laws reject the claim. of nature are not eligible for patenting, methods and products employing abstract ideas, natural After USPTO personnel identify and explain in the phenomena, and laws of nature to perform a record the reasons why a claim is for an abstract real-world function may well be. Thus, if a claim is idea, natural phenomenon, or law of nature without directed to a judicial exception, it must be analyzed signi®cantly more, then the burden shifts to the to determine whether the elements of the claim, applicant to either amend the claim or make a considered both individually and as an ordered showing of why the claim is eligible for patent combination, are suf®cient to ensure that the claim protection. See, e.g., In re Brana, 51 F.3d 1560, as a whole amounts to signi®cantly more than the 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995). exception itself - this has been termed a search for an inventive concept. Alice Corp., 134 S. Ct. at Under the principles of compact prosecution, 2357, 110 USPQ2d at 1981. This analysis considers regardless of whether a rejection under 35 U.S.C. whether the claim as a whole is for a particular 101 is made based on lack of subject matter application of an abstract idea, natural phenomenon, eligibility, a complete examination should be made or law of nature, as opposed to the abstract idea, for every claim under each of the other patentability natural phenomenon, or law of nature itself. Mayo requirements: 35 U.S.C. 102, 103, 112, and 101 Collaborative Serv. v. Prometheus Labs., Inc., 566 (utility, inventorship and double patenting) and U.S. _, 132 S. Ct. 1289, 1293-94, 101 USPQ2d 1961, non-statutory double patenting. Thus, Of®ce 1965-66 (2012) (citing Diehr, 450 U.S. at 187, 209 personnel should state all non-cumulative reasons USPQ at 7). and bases for rejecting claims in the ®rst Of®ce action. For a detailed discussion of the analysis required to determine whether a claim is directed to 2106.01 [Reserved] patent-eligible subject matter, see the 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 2107 Guidelines for Examination of Fed. Reg. 74618 (December 16, 2014) and related Applications for Compliance with the Utility materials available at www.uspto.gov Requirement [R-11.2013] /patent/laws-and-regulations/examination-policy/2014- interim-guidance-subject-matter-eligibility-0. I. INTRODUCTION III. Establish on the Record a Prima Facie Case The following Guidelines establish the policies and procedures to be followed by Of®ce personnel in USPTO personnel should review the totality of the the evaluation of any patent application for evidence (e.g., the speci®cation, claims, relevant compliance with the utility requirements of 35 prior art) before reaching a conclusion with regard U.S.C. 101 and 35 U.S.C. 112(a), or pre-AIA 35 to whether the claimed invention sets forth patent U.S.C. 112, ®rst paragraph. These Guidelines have eligible subject matter. USPTO personnel must reach been promulgated to assist Of®ce personnel in their a conclusion as to whether it is more likely than not review of applications for compliance with the utility that the claimed invention as a whole either falls requirement. The Guidelines do not alter the outside of one of the enumerated statutory classes

Rev. 07.2015, October 2015 2100-16 PATENTABILITY § 2107

substantive requirements of 35 U.S.C. 101 and 35 the art, do not impose a rejection based on lack of U.S.C. 112, nor are they designed to obviate the utility. examiner's review of applications for compliance with all other statutory requirements for patentability. (i) A claimed invention must have a The Guidelines do not constitute substantive speci®c and substantial utility. This requirement rulemaking and hence do not have the force and excludes ªthrow-away,º ªinsubstantial,º or effect of law. Rejections will be based upon the ªnonspeci®cº utilities, such as the use of a complex substantive law, and it is these rejections which are invention as land®ll, as a way of satisfying the utility appealable. Consequently, any perceived failure by requirement of 35 U.S.C. 101. Of®ce personnel to follow these Guidelines is neither (ii) Credibility is assessed from the appealable nor petitionable. perspective of one of ordinary skill in the art in view of the disclosure and any other evidence of record II. EXAMINATION GUIDELINES FOR THE (e.g., test data, af®davits or declarations from experts UTILITY REQUIREMENT in the art, patents or printed publications) that is probative of the applicant's assertions. An applicant Of®ce personnel are to adhere to the following need only provide one credible assertion of speci®c procedures when reviewing patent applications for and substantial utility for each claimed invention to compliance with the ªuseful inventionº (ªutilityº) satisfy the utility requirement. requirement of 35 U.S.C. 101 and 35 U.S.C. 112(a) (2) If no assertion of speci®c and substantial or pre-AIA 35 U.S.C. 112, ®rst paragraph. utility for the claimed invention made by the applicant is credible, and the claimed invention does (A) Read the claims and the supporting written not have a readily apparent well-established utility, description. reject the claim(s) under 35 U.S.C. 101 on the (1) Determine what the applicant has grounds that the invention as claimed lacks utility. claimed, noting any speci®c embodiments of the Also reject the claims under 35 U.S.C. 112(a) or invention. pre-AIA 35 U.S.C. 112, ®rst paragraph, on the basis (2) Ensure that the claims de®ne statutory that the disclosure fails to teach how to use the subject matter (i.e., a process, machine, manufacture, invention as claimed. The 35 U.S.C. 112(a) or composition of matter, or improvement thereof). pre-AIA 35 U.S.C. 112, ®rst paragraph, rejection imposed in conjunction with a 35 U.S.C. 101 (3) If at any time during the examination, it rejection should incorporate by reference the grounds becomes readily apparent that the claimed invention of the corresponding 35 U.S.C. 101 rejection. has a well-established utility, do not impose a rejection based on lack of utility. An invention has (3) If the applicant has not asserted any a well-established utility if (i) a person of ordinary speci®c and substantial utility for the claimed skill in the art would immediately appreciate why invention and it does not have a readily apparent the invention is useful based on the characteristics well-established utility, impose a rejection under 35 of the invention (e.g., properties or applications of U.S.C. 101, emphasizing that the applicant has not a product or process), and (ii) the utility is speci®c, disclosed a speci®c and substantial utility for the substantial, and credible. invention. Also impose a separate rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst (B) Review the claims and the supporting written paragraph, on the basis that the applicant has not description to determine if the applicant has asserted disclosed how to use the invention due to the lack for the claimed invention any speci®c and substantial of a speci®c and substantial utility. The 35 U.S.C. utility that is credible: 101 and 35 U.S.C. 112 rejections shift the burden (1) If the applicant has asserted that the of coming forward with evidence to the applicant claimed invention is useful for any particular to: practical purpose (i.e., it has a ªspeci®c and (i) Explicitly identify a speci®c and substantial utilityº) and the assertion would be substantial utility for the claimed invention; and considered credible by a person of ordinary skill in

2100-17 Rev. 07.2015, October 2015 § 2107 MANUAL OF PATENT EXAMINING PROCEDURE

(ii) Provide evidence that one of ordinary applicant for the claimed invention. The prima facie skill in the art would have recognized that the showing must contain the following elements: identi®ed speci®c and substantial utility was (i) An explanation that clearly sets well-established at the time of ®ling. The examiner forth the reasoning used in concluding that the should review any subsequently submitted evidence asserted speci®c and substantial utility is not of utility using the criteria outlined above. The credible; examiner should also ensure that there is an adequate nexus between the evidence and the properties of (ii) Support for factual ®ndings relied the now claimed subject matter as disclosed in the upon in reaching this conclusion; and application as ®led. That is, the applicant has the (iii) An evaluation of all relevant burden to establish a probative relation between the evidence of record, including utilities taught in the submitted evidence and the originally disclosed closest prior art. properties of the claimed invention. (3) Where no speci®c and substantial (C) Any rejection based on lack of utility utility is disclosed or is well-established, a prima should include a detailed explanation why the facie showing of no speci®c and substantial utility claimed invention has no speci®c and substantial need only establish that applicant has not asserted a credible utility. Whenever possible, the examiner utility and that, on the record before the examiner, should provide documentary evidence regardless of there is no known well-established utility. publication date (e.g., scienti®c or technical journals, (D) A rejection based on lack of utility excerpts from treatises or books, or U.S. or foreign should not be maintained if an asserted utility for patents) to support the factual basis for the prima the claimed invention would be considered speci®c, facie showing of no speci®c and substantial credible substantial, and credible by a person of ordinary skill utility. If documentary evidence is not available, the in the art in view of all evidence of record. examiner should speci®cally explain the scienti®c basis for his or her factual conclusions. Of®ce personnel are reminded that they must treat (1) Where the asserted utility is not as true a statement of fact made by an applicant in speci®c or substantial, a prima facie showing must relation to an asserted utility, unless countervailing establish that it is more likely than not that a person evidence can be provided that shows that one of of ordinary skill in the art would not consider that ordinary skill in the art would have a legitimate basis any utility asserted by the applicant would be to doubt the credibility of such a statement. speci®c and substantial. The prima facie showing Similarly, Of®ce personnel must accept an opinion must contain the following elements: from a quali®ed expert that is based upon relevant facts whose accuracy is not being questioned; it is (i) An explanation that clearly sets improper to disregard the opinion solely because of forth the reasoning used in concluding that the a disagreement over the signi®cance or meaning of asserted utility for the claimed invention is not both the facts offered. speci®c and substantial nor well-established; (ii) Support for factual ®ndings relied Once a prima facie showing of no speci®c and upon in reaching this conclusion; and substantial credible utility has been properly (iii) An evaluation of all relevant established, the applicant bears the burden of evidence of record, including utilities taught in the rebutting it. The applicant can do this by amending closest prior art. the claims, by providing reasoning or arguments, or by providing evidence in the form of a declaration (2) Where the asserted speci®c and under 37 CFR 1.132 or a patent or a printed substantial utility is not credible, a prima facie publication that rebuts the basis or logic of the prima showing of no speci®c and substantial credible utility facie showing. If the applicant responds to the prima must establish that it is more likely than not that a facie rejection, the Of®ce personnel should review person skilled in the art would not consider credible the original disclosure, any evidence relied upon in any speci®c and substantial utility asserted by the establishing the prima facie showing, any claim

Rev. 07.2015, October 2015 2100-18 PATENTABILITY § 2107.01

amendments, and any new reasoning or evidence regarding correction of inventorship, and MPEP § provided by the applicant in support of an asserted 706.03(a), subsection IV, for rejections under 35 speci®c and substantial credible utility. It is essential U.S.C. 101 and 115 (and pre-AIA 35 U.S.C. 102(f) for Of®ce personnel to recognize, fully consider and for applications subject to pre-AIA 35 U.S.C. 102) respond to each substantive element of any response for failure to set forth the correct inventorship). to a rejection based on lack of utility. Only where Third, 35 U.S.C. 101 de®nes which categories of the totality of the record continues to show that the inventions are eligible for patent protection. An asserted utility is not speci®c, substantial, and invention that is not a machine, an article of credible should a rejection based on lack of utility manufacture, a composition or a process cannot be be maintained. patented. See Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980); Diamond v. Diehr, 450 If the applicant satisfactorily rebuts a prima facie U.S. 175, 209 USPQ 1 (1981); In re Nuijten, 500 rejection based on lack of utility under 35 U.S.C. F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 101, withdraw the 35 U.S.C. 101 rejection and the 2007). Fourth, 35 U.S.C. 101 serves to ensure that corresponding rejection imposed under 35 U.S.C. patents are granted on only those inventions that are 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. ªuseful.º This second purpose has a Constitutional footing Ð Article I, Section 8 of the Constitution 2107.01 General Principles Governing Utility authorizes Congress to provide exclusive rights to Rejections [R-07.2015] inventors to promote the ªuseful arts.º See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 35 U.S.C. 101 Inventions patentable USPQ2d 1094 (Fed. Cir. 1991). Thus, to satisfy the requirements of 35 U.S.C. 101, an applicant must Whoever invents or discovers any new and useful process, claim an invention that is statutory subject matter machine, manufacture, or composition of matter, or any new and must show that the claimed invention is ªusefulº and useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title. for some purpose either explicitly or implicitly. Application of this latter element of 35 U.S.C. 101 See MPEP § 2107 for guidelines for the examination is the focus of these guidelines. of applications for compliance with the utility requirement of 35 U.S.C. 101. De®ciencies under the ªuseful inventionº requirement of 35 U.S.C. 101 will arise in one of The Of®ce must examine each application to ensure two forms. The ®rst is where it is not apparent why compliance with the ªuseful inventionº or utility the invention is ªuseful.º This can occur when an requirement of 35 U.S.C. 101. In discharging this applicant fails to identify any speci®c and substantial obligation, however, Of®ce personnel must keep in utility for the invention or fails to disclose enough mind several general principles that control information about the invention to make its application of the utility requirement. 35 U.S.C. 101 usefulness immediately apparent to those familiar has been interpreted as imposing four purposes. First, with the technological ®eld of the invention. 35 U.S.C. 101 limits an inventor to ONE patent for Brenner v. Manson, 383 U.S. 519, 148 USPQ 689 a claimed invention. If more than one patent is (1966); In re Fisher, 421 F.3d 1365, 76 USPQ2d sought, a patent applicant will receive a statutory 1225 (Fed. Cir. 2005); In re Ziegler, 992 F.2d 1197, double patenting rejection for claims included in 26 USPQ2d 1600 (Fed. Cir. 1993). The second type more than one application that are directed to the of de®ciency arises in the rare instance where an same invention. See MPEP § 804. Second, the assertion of speci®c and substantial utility for the inventor(s) must be the applicant in an application invention made by an applicant is not credible. ®led before September 16, 2012, (except as otherwise provided in pre-AIA 37 CFR 1.41(b)) and I. SPECIFIC AND SUBSTANTIAL the inventor or each joint inventor must be identi®ed REQUIREMENTS in an application ®led on or after September 16, 2012. See MPEP § 2137.01 for a detailed discussion To satisfy 35 U.S.C. 101, an invention must be of inventorship, MPEP § 602.01(c) et seq. for details ªuseful.º Courts have recognized that the term

2100-19 Rev. 07.2015, October 2015 § 2107.01 MANUAL OF PATENT EXAMINING PROCEDURE

ªusefulº used with reference to the utility invention. Of®ce personnel should distinguish requirement can be a dif®cult term to de®ne. between situations where an applicant has disclosed Brenner v. Manson, 383 U.S. 519, 529, 148 USPQ a speci®c use for or application of the invention and 689, 693 (1966) (simple everyday word like ªusefulº situations where the applicant merely indicates that can be ªpregnant with ambiguity when applied the invention may prove useful without identifying to the facts of life.º). Where an applicant has set with speci®city why it is considered useful. For forth a speci®c and substantial utility, courts have example, indicating that a compound may be useful been reluctant to uphold a rejection under 35 U.S.C. in treating unspeci®ed disorders, or that the 101 solely on the basis that the applicant's opinion compound has ªuseful biologicalº properties, would as to the nature of the speci®c and substantial utility not be suf®cient to de®ne a speci®c utility for the was inaccurate. For example, in Nelson v. Bowler, compound. See, e.g., In re Kirk, 376 F.2d 936, 153 626 F.2d 853, 206 USPQ 881 (CCPA 1980), the USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, court reversed a ®nding by the Of®ce that the 153 USPQ 45 (CCPA 1967). Similarly, a claim to applicant had not set forth a ªpracticalº utility under a polynucleotide whose use is disclosed simply as a 35 U.S.C. 101. In this case the applicant asserted ªgene probeº or ªchromosome markerº would not that the composition was ªusefulº in a particular be considered to be speci®c in the absence of a pharmaceutical application and provided evidence disclosure of a speci®c DNA target. See In re to support that assertion. Courts have used the labels Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232 (ªAny ªpractical utility,º ªsubstantial utility,º or ªspeci®c EST [expressed sequence tag] transcribed from any utilityº to refer to this aspect of the ªuseful gene in the maize genome has the potential to inventionº requirement of 35 U.S.C. 101. The Court perform any one of the alleged uses¼. Nothing of Customs and Patent Appeals has stated: about [applicant's] seven alleged uses set the ®ve claimed ESTs apart from the more than 32,000 ESTs Practical utility is a shorthand way of disclosed in the [ ] application or indeed from any attributing ªreal-worldº value to claimed EST derived from any organism. Accordingly, we subject matter. In other words, one skilled in conclude that [applicant] has only disclosed general the art can use a claimed discovery in a manner uses for its claimed ESTs, not speci®c ones that which provides some immediate bene®t to the satisfy § 101.º). A general statement of diagnostic public. utility, such as diagnosing an unspeci®ed disease, would ordinarily be insuf®cient absent a disclosure of what condition can be diagnosed. Contrast the Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ situation where an applicant discloses a speci®c 881, 883 (CCPA 1980). biological activity and reasonably correlates that activity to a disease condition. Assertions falling Practical considerations require the Of®ce to rely within the latter category are suf®cient to identify a on the inventor's understanding of his or her speci®c utility for the invention. Assertions that fall invention in determining whether and in what regard in the former category are insuf®cient to de®ne a an invention is believed to be ªuseful.º Because of speci®c utility for the invention, especially if the this, Of®ce personnel should focus on and be assertion takes the form of a general statement that receptive to assertions made by the applicant that an makes it clear that a ªusefulº invention may arise invention is ªusefulº for a particular reason. from what has been disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 A. Speci®c Utility (CCPA 1973).

A ªspeci®c utilityº is speci®c to the subject matter B. Substantial Utility claimed and can ªprovide a well-de®ned and particular bene®t to the public.º In re Fisher, 421 ª[A]n application must show that an invention is F.3d 1365, 1371, 76 USPQ2d 1225, 1230 (Fed. Cir. useful to the public as disclosed in its current form, 2005). This contrasts with a general utility that not that it may prove useful at some future date after would be applicable to the broad class of the further research. Simply put, to satisfy the

Rev. 07.2015, October 2015 2100-20 PATENTABILITY § 2107.01

`substantial' utility requirement, an asserted use must (D) A method of making a material that itself show that the claimed invention has a signi®cant has no speci®c, substantial, and credible utility; and and presently available bene®t to the public.º (E) A claim to an intermediate product for use Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The in making a ®nal product that has no speci®c, claims at issue in Fisher were directed to expressed substantial and credible utility. sequence tags (ESTs), which are short nucleotide sequences that can be used to discover what genes Of®ce personnel must be careful not to interpret the and downstream proteins are expressed in a cell. The phrase ªimmediate bene®t to the publicº or similar court held that ªthe claimed ESTs can be used only formulations in other cases to mean that products or to gain further information about the underlying services based on the claimed invention must be genes and the proteins encoded for by those genes. ªcurrently availableº to the public in order to satisfy The claimed ESTs themselves are not an end of the utility requirement. See, e.g., Brenner v. [applicant's] research effort, but only tools to be Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695 used along the way in the search for a practical (1966). Rather, any reasonable use that an applicant utility¼. [Applicant] does not identify the function has identi®ed for the invention that can be viewed for the underlying protein-encoding genes. Absent as providing a public bene®t should be accepted as such identi®cation, we hold that the claimed ESTs suf®cient, at least with regard to de®ning a have not been researched and understood to the point ªsubstantialº utility. of providing an immediate, well-de®ned, real world bene®t to the public meriting the grant of a patent.º C. Research Tools Id. at 1376, 76 USPQ2d at 1233-34). Thus a ªsubstantial utilityº de®nes a ªreal worldº use. Some confusion can result when one attempts to Utilities that require or constitute carrying out further label certain types of inventions as not being capable research to identify or reasonably con®rm a ªreal of having a speci®c and substantial utility based on worldº context of use are not substantial utilities. the setting in which the invention is to be used. One For example, both a therapeutic method of treating example is inventions to be used in a research or a known or newly discovered disease and an assay laboratory setting. Many research tools such as gas method for identifying compounds that themselves chromatographs, screening assays, and nucleotide have a ªsubstantial utilityº de®ne a ªreal worldº sequencing techniques have a clear, speci®c and context of use. An assay that measures the presence unquestionable utility (e.g., they are useful in of a material which has a stated correlation to a analyzing compounds). An assessment that focuses predisposition to the onset of a particular disease on whether an invention is useful only in a research condition would also de®ne a ªreal worldº context setting thus does not address whether the invention of use in identifying potential candidates for is in fact ªusefulº in a patent sense. Instead, Of®ce preventive measures or further monitoring. On the personnel must distinguish between inventions that other hand, the following are examples of situations have a speci®cally identi®ed substantial utility and that require or constitute carrying out further research inventions whose asserted utility requires further to identify or reasonably con®rm a ªreal worldº research to identify or reasonably con®rm. Labels context of use and, therefore, do not de®ne such as ªresearch tool,º ªintermediateº or ªfor ªsubstantial utilitiesº: research purposesº are not helpful in determining if an applicant has identi®ed a speci®c and substantial (A) Basic research such as studying the utility for the invention. properties of the claimed product itself or the mechanisms in which the material is involved; II. WHOLLY INOPERATIVE INVENTIONS; ªINCREDIBLEº UTILITY (B) A method of treating an unspeci®ed disease or condition; An invention that is ªinoperativeº (i.e., it does not (C) A method of assaying for or identifying a operate to produce the results claimed by the patent material that itself has no speci®c and/or substantial applicant) is not a ªusefulº invention in the meaning utility; of the patent law. See, e.g., Newman v. Quigg,

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877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. USPQ 209 (CCPA 1977). However cast, the Cir. 1989); In re Harwood, 390 F.2d 985, 989, underlying ®nding by the court in these cases was 156 USPQ 673, 676 (CCPA 1968) (ªAn inoperative that, based on the factual record of the case, it was invention, of course, does not satisfy the requirement clear that the invention could not and did not work of 35 U.S.C. 101 that an invention be useful.º). as the inventor claimed it did. Indeed, the use of However, as the Federal Circuit has stated, ª[t]o many labels to describe a single problem (e.g., a violate [35 U.S.C.] 101 the claimed device must be false assertion regarding utility) has led to some of totally incapable of achieving a useful result.º the confusion that exists today with regard to a Brooktree Corp. v. Advanced Micro Devices, Inc., rejection based on the ªutilityº requirement. 977 F.2d 1555, 1571, 24 USPQ2d 1401, 1412 (Fed. Examples of such cases include: an invention Cir. 1992) (emphasis added). See also E.I. du Pont asserted to change the taste of food using a magnetic De Nemours and Co. v. Berkley and Co., 620 F.2d ®eld (Fregeau v. Mossinghoff, 776 F.2d 1034, 227 1247, 1260 n.17, 205 USPQ 1, 10 n.17 (8th Cir. USPQ 848 (Fed. Cir. 1985)), a perpetual motion 1980) (ªA small degree of utility is suf®cient . . . machine (Newman v. Quigg, 877 F.2d 1575, 11 The claimed invention must only be capable of USPQ2d 1340 (Fed. Cir. 1989)), a ¯ying machine performing some bene®cial function . . . An operating on ª¯apping or ¯utter functionº (In re invention does not lack utility merely because the Houghton, 433 F.2d 820, 167 USPQ 687 (CCPA particular embodiment disclosed in the patent lacks 1970)), a ªcold fusionº process for producing energy perfection or performs crudely . . . A commercially (In re Swartz, 232 F.3d 862, 56 USPQ2d 1703 (Fed. successful product is not required . . . Nor is it Cir. 2000)), a method for increasing the energy essential that the invention accomplish all its output of fossil fuels upon combustion through intended functions . . . or operate under all conditions exposure to a magnetic ®eld (In re Ruskin, 354 F.2d . . . partial success being suf®cient to demonstrate 395, 148 USPQ 221 (CCPA 1966)), uncharacterized patentable utility . . . In short, the defense of compositions for curing a wide array of cancers (In non-utility cannot be sustained without proof of total re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA incapacity.º If an invention is only partially 1963)), and a method of controlling the aging process successful in achieving a useful result, a rejection (In re Eltgroth, 419 F.2d 918, 164 USPQ 221 of the claimed invention as a whole based on a lack (CCPA 1970)). These examples are fact speci®c and of utility is not appropriate. See In re Brana, 51 should not be applied as a per se rule. Thus, in view F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995); In of the rare nature of such cases, Of®ce personnel re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA), should not label an asserted utility ªincredible,º reh'g denied, 480 F.2d 879 (CCPA 1973); In re ªspeculativeº or otherwise unless it is clear that a Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA rejection based on ªlack of utilityº is proper. 1971). III. THERAPEUTIC OR PHARMACOLOGICAL Situations where an invention is found to be UTILITY ªinoperativeº and therefore lacking in utility are rare, and rejections maintained solely on this ground by Inventions asserted to have utility in the treatment a federal court even rarer. In many of these cases, of human or animal disorders are subject to the same the utility asserted by the applicant was thought to legal requirements for utility as inventions in any be ªincredible in the light of the knowledge of the other ®eld of technology. In re Chilowsky, 229 F.2d art, or factually misleadingº when initially 457, 461-2, 108 USPQ 321, 325 (CCPA 1956) considered by the Of®ce. In re Citron, 325 F.2d (ªThere appears to be no basis in the statutes or 248, 253, 139 USPQ 516, 520 (CCPA 1963). Other decisions for requiring any more conclusive evidence cases suggest that on initial evaluation, the Of®ce of operativeness in one type of case than another. considered the asserted utility to be inconsistent with The character and amount of evidence needed may known scienti®c principles or ªspeculative at bestº vary, depending on whether the alleged operation as to whether attributes of the invention necessary described in the application appears to accord with to impart the asserted utility were actually present or to contravene established scienti®c principles or in the invention. In re Sichert, 566 F.2d 1154, 196 to depend upon principles alleged but not generally

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recognized, but the degree of certainty as to the persuasively disclose in his application a practical ultimate fact of operativeness or inoperativeness utility for the invention. Nelson had developed and should be the same in all casesº); In re Gazave, 379 claimed a class of synthetic prostaglandins modeled F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967) on naturally occurring prostaglandins. Naturally (ªThus, in the usual case where the mode of occurring prostaglandins are bioactive compounds operation alleged can be readily understood and that, at the time of Nelson's application, had a conforms to the known laws of physics and recognized value in pharmacology (e.g., the chemistry, operativeness is not questioned, and no stimulation of uterine smooth muscle which resulted further evidence is required.º). As such, in labor induction or abortion, the ability to raise or pharmacological or therapeutic inventions that lower blood pressure, etc.). To support the utility he provide any ªimmediate bene®t to the publicº satisfy identi®ed in his disclosure, Nelson included in his 35 U.S.C. 101. The utility being asserted in Nelson application the results of tests demonstrating the related to a compound with pharmacological utility. bioactivity of his new substituted prostaglandins Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ relative to the bioactivity of naturally occurring 881, 883 (CCPA 1980). Of®ce personnel should rely prostaglandins. The court concluded that Nelson had on Nelson and other cases as providing general satis®ed the practical utility requirement in guidance when evaluating the utility of an invention identifying the synthetic prostaglandins as that is based on any therapeutic, prophylactic, or pharmacologically active compounds. In reaching pharmacological activities of that invention. this conclusion, the court considered and rejected arguments advanced by Bowler that attacked the Courts have repeatedly found that the mere evidentiary basis for Nelson's assertions that the identi®cation of a pharmacological activity of a compounds were pharmacologically active. compound that is relevant to an asserted pharmacological use provides an ªimmediate bene®t In In re Jolles, 628 F.2d 1322, 206 USPQ 885 to the publicº and thus satis®es the utility (CCPA 1980), an inventor claimed protection for requirement. As the Court of Customs and Patent pharmaceutical compositions for treating Appeals held in Nelson v. Bowler: leukemia. The active ingredient in the compositions was a structural analog to a known anticancer agent. Knowledge of the pharmacological activity of The applicant provided evidence showing that the any compound is obviously bene®cial to the claimed analogs had the same general public. It is inherently faster and easier to pharmaceutical activity as the known anticancer combat illnesses and alleviate symptoms when agents. The court reversed the Board's ®nding that the medical profession is armed with an arsenal the asserted pharmaceutical utility was ªincredible,º of chemicals having known pharmacological pointing to the evidence that showed the relevant activities. Since it is crucial to provide pharmacological activity. researchers with an incentive to disclose pharmacological activities in as many In Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 compounds as possible, we conclude that (Fed. Cir. 1985), the Federal Circuit af®rmed a adequate proof of any such activity constitutes ®nding by the Board of Patent Appeals and a showing of practical utility. Interferences that a pharmacological utility had been disclosed in the application of one party to an interference proceeding. The invention that was the Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ subject of the interference count was a chemical 881, 883 (CCPA 1980). compound used for treating blood disorders. Cross had challenged the evidence in Iizuka's speci®cation In Nelson v. Bowler, the court addressed the that supported the claimed utility. However, the practical utility requirement in the context of an Federal Circuit relied extensively on interference proceeding. Bowler challenged the Nelson v. Bowler in ®nding that Iizuka's application patentability of the invention claimed by Nelson on had suf®ciently disclosed a pharmacological utility the basis that Nelson had failed to suf®ciently and for the compounds. It distinguished the case from

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cases where only a generalized ªnebulousº associated costs would prevent many companies expression, such as ªbiological properties,º had been from obtaining patent protection on promising disclosed in a speci®cation. Such statements, the new inventions, thereby eliminating an court held, ªconvey little explicit indication incentive to pursue, through research and regarding the utility of a compound.º Cross, 753 development, potential cures in many crucial F.2d at 1048, 224 USPQ at 745 (citing In re Kirk, areas such as the treatment of cancer. 376 F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)). In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Similarly, courts have found utility for therapeutic Cir. 1995). Accordingly, Of®ce personnel should inventions despite the fact that an applicant is at a not construe 35 U.S.C. 101, under the logic of very early stage in the development of a ªpracticalº utility or otherwise, to require that an pharmaceutical product or therapeutic regimen based applicant demonstrate that a therapeutic agent based on a claimed pharmacological or bioactive on a claimed invention is a safe or fully effective compound or composition. The Federal Circuit, in drug for humans. See, e.g., In re Sichert, 566 F.2d Cross v. Iizuka, 753 F.2d 1040, 1051, 224 USPQ 1154, 196 USPQ 209 (CCPA 1977); In re Hartop, 739, 747-48 (Fed. Cir. 1985), commented on the 311 F.2d 249, 135 USPQ 419 (CCPA 1962); In re signi®cance of data from in vitro testing that showed Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA pharmacological activity: 1969); In re Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975). We perceive no insurmountable dif®culty, under appropriate circumstances, in ®nding that These general principles are equally applicable to the ®rst link in the screening chain, in vitro situations where an applicant has claimed a process testing, may establish a practical utility for the for treating a human or animal disorder. In such compound in question. Successful in vitro cases, the asserted utility is usually clear Ð the testing will marshal resources and direct the invention is asserted to be useful in treating the expenditure of effort to further in vivo testing particular disorder. If the asserted utility is credible, of the most potent compounds, thereby there is no basis to challenge such a claim on the providing an immediate bene®t to the public, basis that it lacks utility under 35 U.S.C. 101. analogous to the bene®t provided by the showing of an in vivo utility. See MPEP § 2107.03 for special considerations for asserted therapeutic or pharmacological utilities. The Federal Circuit has reiterated that therapeutic utility suf®cient under the patent laws is not to be IV. RELATIONSHIP BETWEEN 35 U.S.C. 112(a) confused with the requirements of the FDA with or Pre-AIA 35 U.S.C. 112, FIRST PARAGRAPH, regard to safety and ef®cacy of drugs to marketed AND 35 U.S.C. 101 in the United States. A de®ciency under the utility prong of35 U.S.C. 101 FDA approval, however, is not a prerequisite also creates a de®ciency under 35 U.S.C. 112(a) or for ®nding a compound useful within the pre-AIA 35 U.S.C. 112, ®rst paragraph. See In re meaning of the patent laws. Scott v. Finney, Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 1995); In re Jolles, 628 F.2d 1322, 1326 n.10, 206 [(Fed.Cir. 1994)]. Usefulness in patent law, and USPQ 885, 889 n.11 (CCPA 1980); In re Fouche, in particular in the context of pharmaceutical 439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA inventions, necessarily includes the expectation 1971) (ªIf such compositions are in fact useless, of further research and development. The stage appellant's speci®cation cannot have taught how to at which an invention in this ®eld becomes use them.º). Courts have also cast the 35 U.S.C. useful is well before it is ready to be 101/35 U.S.C. 112 relationship such that 35 U.S.C. administered to humans. Were we to require 112 presupposes compliance with 35 U.S.C. 101. Phase II testing in order to prove utility, the See In re Ziegler, 992 F.2d 1197, 1200-1201, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993) (ªThe how to

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use prong of section 112 incorporates as a matter of must be provided if a rejection under 35 U.S.C. law the requirement of 35 U.S.C. 101 that the 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, speci®cation disclose as a matter of fact a practical is to be imposed on ªlack of utilityº grounds. utility for the invention. ... If the application fails as a matter of fact to satisfy 35 U.S.C. § 101, then the It is important to recognize that 35 U.S.C. 112(a) or application also fails as a matter of law to enable pre-AIA 35 U.S.C. 112, ®rst paragraph, addresses one of ordinary skill in the art to use the invention matters other than those related to the question of under 35 U.S.C. § 112.º); In re Kirk, 376 F.2d 936, whether or not an invention lacks utility. These 942, 153 USPQ 48, 53 (CCPA 1967) (ªNecessarily, matters include whether the claims are fully compliance with § 112 requires a description of how supported by the disclosure (In re Vaeck, 947 F.2d to use presently useful inventions, otherwise an 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991)), applicant would anomalously be required to teach whether the applicant has provided an enabling how to use a useless invention.º). For example, the disclosure of the claimed subject matter (In re Federal Circuit noted, ª[o]bviously, if a claimed Wright, 999 F.2d 1557, 1561-1562, 27 USPQ2d invention does not have utility, the speci®cation 1510, 1513 (Fed. Cir. 1993)), whether the applicant cannot enable one to use it.º In re Brana, 51 F.3d has provided an adequate written description of the 1560, 34 USPQ2d 1436 (Fed. Cir. 1995). As such, invention and whether the applicant has disclosed a rejection properly imposed under 35 U.S.C. 101 the best mode of practicing the claimed invention for lack of utility should be accompanied with a (Chemcast Corp. v. Arco Indus. Corp., 913 F.2d rejection under 35 U.S.C. 112(a) or pre-AIA 35 923, 927-928, 16 USPQ2d 1033, 1036-1037 (Fed. U.S.C. 112, ®rst paragraph. It is equally clear that a Cir. 1990)). See also Transco Products Inc. v. rejection based on ªlack of utility,º whether Performance Contracting Inc., 38 F.3d 551, 32 grounded upon 35 U.S.C. 101 or 35 U.S.C. 112(a) USPQ2d 1077 (Fed. Cir. 1994); Glaxo or pre-AIA 35 U.S.C. 112, ®rst paragraph, rests on Inc. v. Novopharm Ltd., 52 F.3d 1043, 34 USPQ2d the same basis (i.e., the asserted utility is not 1565 (Fed. Cir. 1995). The fact that an applicant has credible). To avoid confusion, any lack of utility disclosed a speci®c utility for an invention and rejection that is imposed on the basis of 35 U.S.C. provided a credible basis supporting that speci®c 101 should be accompanied by a rejection based on utility does not provide a basis for concluding that 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst the claims comply with all the requirements of 35 paragraph. The 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst U.S.C. 112, ®rst paragraph, rejection should be set paragraph. For example, if an applicant has claimed out as a separate rejection that incorporates by a process of treating a certain disease condition with reference the factual basis and conclusions set forth a certain compound and provided a credible basis in the 35 U.S.C. 101 rejection. The 35 U.S.C. 112(a) for asserting that the compound is useful in that or pre-AIA 35 U.S.C. 112, ®rst paragraph, rejection regard, but to actually practice the invention as should indicate that because the invention as claimed claimed a person skilled in the relevant art would does not have utility, a person skilled in the art would have to engage in an undue amount of not be able to use the invention as claimed, and as experimentation, the claim may be defective under such, the claim is defective under 35 U.S.C. 112(a) 35 U.S.C. 112, but not 35 U.S.C. 101. To avoid or pre-AIA 35 U.S.C. 112, ®rst paragraph. A 35 confusion during examination, any rejection under U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, rejection based on lack of utility should paragraph, based on grounds other than ªlack of not be imposed or maintained unless an appropriate utilityº should be imposed separately from any basis exists for imposing a utility rejection under rejection imposed due to ªlack of utilityº under 35 35 U.S.C. 101. In other words, Of®ce personnel should not impose a 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, rejection grounded on a ªlack of utilityº basis unless a 35 U.S.C. 101 rejection is proper. In particular, the factual showing needed to impose a rejection under 35 U.S.C. 101

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U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 meets at least one stated objective, utility under 35 U.S.C. 112, ®rst paragraph. U.S.C. 101 is clearly shown.º); In re Gottlieb, 328 F.2d 1016, 1019, 140 USPQ 665, 668 (CCPA 1964) 2107.02 Procedural Considerations Related (ªHaving found that the antibiotic is useful for some to Rejections for Lack of Utility [R-11.2013] purpose, it becomes unnecessary to decide whether it is in fact useful for the other purposes `indicated' I. THE CLAIMED INVENTION IS THE FOCUS OF in the speci®cation as possibly useful.º); In re THE UTILITY REQUIREMENT Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976); Hoffman v. Klaus, 9 USPQ2d 1657 (Bd. Pat. The claimed invention is the focus of the assessment App. & Inter. 1988). Thus, if applicant makes one of whether an applicant has satis®ed the utility credible assertion of utility, utility for the claimed requirement. Each claim (i.e., each ªinventionº), invention as a whole is established. therefore, must be evaluated on its own merits for compliance with all statutory requirements. Statements made by the applicant in the speci®cation Generally speaking, however, a dependent claim or incident to prosecution of the application before will de®ne an invention that has utility if the the Of®ce cannot, standing alone, be the basis for a independent claim from which the dependent claim lack of utility rejection under 35 U.S.C. 101 or 35 depends is drawn to the same statutory class of U.S.C. 112. Tol-O-Matic, Inc. v. Proma invention as the dependent claim and the independent Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d claim de®nes an invention having utility. An 1546, 1553, 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) exception to this general rule is where the utility (It is not required that a particular characteristic set speci®ed for the invention de®ned in a dependent forth in the prosecution history be achieved in order claim differs from that indicated for the invention to satisfy 35 U.S.C. 101.). An applicant may include de®ned in the independent claim from which the statements in the speci®cation whose technical dependent claim depends. Where an applicant has accuracy cannot be easily con®rmed if those established utility for a species that falls within an statements are not necessary to support the identi®ed genus of compounds, and presents a patentability of an invention with regard to any generic claim covering the genus, as a general statutory basis. Thus, the Of®ce should not require matter, that claim should be treated as being an applicant to strike nonessential statements relating suf®cient under 35 U.S.C. 101. Only where it can to utility from a patent disclosure, regardless of the be established that other species clearly encompassed technical accuracy of the statement or assertion it by the claim do not have utility should a rejection presents. Of®ce personnel should also be especially be imposed on the generic claim. In such cases, the careful not to read into a claim unclaimed results, applicant should be encouraged to amend the generic limitations or embodiments of an invention. See claim so as to exclude the species that lack utility. Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991); In re Krimmel, It is common and sensible for an applicant to identify 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing several speci®c utilities for an invention, particularly so can inappropriately change the relationship of an where the invention is a product (e.g., a machine, an asserted utility to the claimed invention and raise article of manufacture or a composition of matter). issues not relevant to examination of that claim. However, regardless of the category of invention that is claimed (e.g., product or process), an applicant II. IS THERE AN ASSERTED OR need only make one credible assertion of speci®c WELL-ESTABLISHED UTILITY FOR THE utility for the claimed invention to satisfy 35 U.S.C. CLAIMED INVENTION? 101 and 35 U.S.C. 112; additional statements of utility, even if not ªcredible,º do not render the Upon initial examination, the examiner should claimed invention lacking in utility. See, e.g., review the speci®cation to determine if there are Raytheon v. Roper, 724 F.2d 951, 958, 220 USPQ any statements asserting that the claimed invention 592, 598 (Fed. Cir. 1983), cert. denied, 469 U.S. is useful for any particular purpose. A complete 835 (1984) (ªWhen a properly claimed invention disclosure should include a statement which

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identi®es a speci®c and substantial utility for the particular therapeutic application of the compound invention. does contain an assertion of speci®c and substantial utility for the invention. A. An Asserted Utility Must Be Speci®c and Substantial Situations where an applicant either fails to indicate A statement of speci®c and substantial utility should why an invention is considered useful, or where the fully and clearly explain why the applicant believes applicant inaccurately describes the utility should the invention is useful. Such statements will usually rarely arise. One reason for this is that applicants are explain the purpose of or how the invention may be required to disclose the best mode known to them used (e.g., a compound is believed to be useful in of practicing the invention at the time they ®le their the treatment of a particular disorder). Regardless application. An applicant who omits a description of the form of statement of utility, it must enable of the speci®c and substantial utility of the invention, one ordinarily skilled in the art to understand why or who incompletely describes that utility, may the applicant believes the claimed invention is useful. encounter problems with respect to the best mode requirement of 35 U.S.C. 112(a) or pre-AIA 35 Except where an invention has a well-established U.S.C. 112, ®rst paragraph. utility, the failure of an applicant to speci®cally identify why an invention is believed to be useful B. No Statement of Utility for the Claimed Invention renders the claimed invention de®cient under 35 in the Speci®cation Does Not Per Se Negate Utility U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. In such cases, the Occasionally, an applicant will not explicitly state applicant has failed to identify a ªspeci®c and in the speci®cation or otherwise assert a speci®c and substantial utilityº for the claimed invention. For substantial utility for the claimed invention. If no example, a statement that a composition has an statements can be found asserting a speci®c and unspeci®ed ªbiological activityº or that does not substantial utility for the claimed invention in the explain why a composition with that activity is speci®cation, Of®ce personnel should determine if believed to be useful fails to set forth a ªspeci®c and the claimed invention has a well-established utility. substantial utility.º Brenner v. Manson, 383 US An invention has a well-established utility if (i) a 519, 148 USPQ 689 (1966) (general assertion of person of ordinary skill in the art would immediately similarities to known compounds known to be useful appreciate why the invention is useful based on the without suf®cient corresponding explanation why characteristics of the invention (e.g., properties or claimed compounds are believed to be similarly applications of a product or process), and (ii) the useful insuf®cient under 35 U.S.C. 101); In re utility is speci®c, substantial, and credible. If an Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, invention has a well- established utility, rejections 1604 (Fed. Cir. 1993) (disclosure that composition under 35 U.S.C. 101 and 35 U.S.C. 112(a) or is ªplastic-likeº and can form ª®lmsº not suf®cient pre-AIA 35 U.S.C. 112, ®rst paragraph, based on to identify speci®c and substantial utility for lack of utility should not be imposed. In re Folkers, invention); In re Kirk, 376 F.2d 936, 153 USPQ 48 344 F.2d 970, 145 USPQ 390 (CCPA 1965). For (CCPA 1967) (indication that compound is example, if an application teaches the cloning and ªbiologically activeº or has ªbiological propertiesº characterization of the nucleotide sequence of a insuf®cient standing alone). See also In re Joly, well-known protein such as insulin, and those skilled 376 F.2d 906, 153 USPQ 45 (CCPA 1967); in the art at the time of ®ling knew that insulin had Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ a well-established use, it would be improper to reject 158, 165 (CCPA 1973) (contrasting description of the claimed invention as lacking utility solely invention as sedative which did suggest speci®c because of the omitted statement of speci®c and utility to general suggestion of ªpharmacological substantial utility. effects on the central nervous systemº which did not). In contrast, a disclosure that identi®es a If a person of ordinary skill would not immediately particular biological activity of a compound and recognize a speci®c and substantial utility for the explains how that activity can be utilized in a claimed invention (i.e., why it would be useful)

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based on the characteristics of the invention or Court of Customs and Patent Appeals in evaluation statements made by the applicant, the examiner of rejections under 35 U.S.C. 112(a) or pre-AIA 35 should reject the application under 35 U.S.C. 101 U.S.C. 112, ®rst paragraph, where the rejection is and under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. based on a de®ciency under 35 U.S.C. 101. In In re 112, ®rst paragraph, as failing to identify a speci®c Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. and substantial utility for the claimed invention. The 1995), the Federal Circuit explicitly adopted the rejection should clearly indicate that the basis of the Court of Customs and Patent Appeals formulation rejection is that the application fails to identify a of the ªLangerº standard for 35 U.S.C. 112(a) or speci®c and substantial utility for the invention. The pre-AIA 35 U.S.C. 112, ®rst paragraph rejections, rejection should also specify that the applicant must as it was expressed in a slightly reworded format in reply by indicating why the invention is believed In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, useful and where support for any subsequently 369 (CCPA 1971), namely: asserted utility can be found in the speci®cation as ®led. See MPEP § 2701. [A] speci®cation disclosure which contains a teaching of the manner and process of making If the applicant subsequently indicates why the and using the invention in terms which invention is useful, Of®ce personnel should review correspond in scope to those used in describing that assertion according to the standards articulated and de®ning the subject matter sought to be below for review of the credibility of an asserted patented must be taken as in compliance with utility. the enabling requirement of the ®rst paragraph of § 112 unless there is reason to doubt the III. EVALUATING THE CREDIBILITY OF AN objective truth of the statements contained ASSERTED UTILITY therein which must be relied on for enabling support. (emphasis added). A. An Asserted Utility Creates a Presumption of Utility Thus, Langer and subsequent cases direct the Of®ce In most cases, an applicant's assertion of utility to presume that a statement of utility made by an creates a presumption of utility that will be suf®cient applicant is true. See In re Langer, 503 F.2d at 1391, to satisfy the utility requirement of 35 U.S.C. 101. 183 USPQ at 297; In re Malachowski, 530 F.2d See, e.g., In re Jolles, 628 F.2d 1322, 206 USPQ 1402, 1404, 189 USPQ 432, 435 (CCPA 1976); In 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144 re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1995). For obvious reasons of ef®ciency and in 1380, 183 USPQ 288 (CCPA 1974); In re Sichert, deference to an applicant's understanding of his or 566 F.2d 1154, 1159, 196 USPQ 209, 212-13 (CCPA her invention, when a statement of utility is 1977). As the Court of Customs and Patent Appeals evaluated, Of®ce personnel should not begin by stated in In re Langer: questioning the truth of the statement of utility. Instead, any inquiry must start by asking if there is As a matter of Patent Of®ce practice, a any reason to question the truth of the statement of speci®cation which contains a disclosure of utility. This can be done by simply evaluating the utility which corresponds in scope to the subject logic of the statements made, taking into matter sought to be patented must be taken as consideration any evidence cited by the applicant. suf®cient to satisfy the utility requirement of If the asserted utility is credible (i.e., believable § 101 for the entire claimed subject matter based on the record or the nature of the invention), unless there is a reason for one skilled in the a rejection based on ªlack of utilityº is not art to question the objective truth of the appropriate. Clearly, Of®ce personnel should not statement of utility or its scope. begin an evaluation of utility by assuming that an asserted utility is likely to be false, based on the In re Langer, 503 F.2d at 1391, 183 USPQ at 297 technical ®eld of the invention or for other general (emphasis in original). The ªLangerº test for utility reasons. has been used by both the Federal Circuit and the

Rev. 07.2015, October 2015 2100-28 PATENTABILITY § 2107.02

Compliance with 35 U.S.C. 101 is a question of fact. assertion of utility is believable to a person of Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ ordinary skill in the art based on the totality of 592, 596 (Fed. Cir. 1983) cert. denied, 469 U.S. 835 evidence and reasoning provided). An assertion is (1984). Thus, to overcome the presumption of truth credible unless (A) the logic underlying the assertion that an assertion of utility by the applicant enjoys, is seriously ¯awed, or (B) the facts upon which the Of®ce personnel must establish that it is more likely assertion is based are inconsistent with the logic than not that one of ordinary skill in the art would underlying the assertion. Credibility as used in this doubt (i.e., ªquestionº) the truth of the statement of context refers to the reliability of the statement based utility. The evidentiary standard to be used on the logic and facts that are offered by the throughout ex parte examination in setting forth a applicant to support the assertion of utility. rejection is a preponderance of the totality of the evidence under consideration. In re Oetiker, 977 One situation where an assertion of utility would not F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. be considered credible is where a person of ordinary 1992) (ªAfter evidence or argument is submitted by skill would consider the assertion to be ªincredible the applicant in response, patentability is determined in view of contemporary knowledgeº and where on the totality of the record, by a preponderance of nothing offered by the applicant would counter what evidence with due consideration to persuasiveness contemporary knowledge might otherwise suggest. of argument.º); In re Corkill, 771 F.2d 1496, Of®ce personnel should be careful, however, not to 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A label certain types of inventions as ªincredibleº or preponderance of the evidence exists when it ªspeculativeº as such labels do not provide the suggests that it is more likely than not that the correct focus for the evaluation of an assertion of assertion in question is true. Herman v. Huddleston, utility. ªIncredible utilityº is a conclusion, not a 459 U.S. 375, 390 (1983). To do this, Of®ce starting point for analysis under 35 U.S.C. 101. A personnel must provide evidence suf®cient to show conclusion that an asserted utility is incredible can that the statement of asserted utility would be be reached only after the Of®ce has evaluated both considered ªfalseº by a person of ordinary skill in the assertion of the applicant regarding utility and the art. Of course, a person of ordinary skill must any evidentiary basis of that assertion. The Of®ce have the bene®t of both facts and reasoning in order should be particularly careful not to start with a to assess the truth of a statement. This means that if presumption that an asserted utility is, per se, the applicant has presented facts that support the ªincredibleº and then proceed to base a rejection reasoning used in asserting a utility, Of®ce personnel under 35 U.S.C. 101 on that presumption. must present countervailing facts and reasoning suf®cient to establish that a person of ordinary skill Rejections under 35 U.S.C. 101 based on a lack of would not believe the applicant's assertion of utility. credible utility have been sustained by federal courts In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. when, for example, the applicant failed to disclose Cir. 1995). The initial evidentiary standard used any utility for the invention or asserted a utility that during evaluation of this question is a preponderance could only be true if it violated a scienti®c principle, of the evidence (i.e., the totality of facts and such as the second law of thermodynamics, or a law reasoning suggest that it is more likely than not that of nature, or was wholly inconsistent with the statement of the applicant is false). contemporary knowledge in the art. In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). B. When Is an Asserted Utility Not Credible? Special care should be taken when assessing the credibility of an asserted therapeutic utility for a Where an applicant has speci®cally asserted that an claimed invention. In such cases, a previous lack of invention has a particular utility, that assertion success in treating a disease or condition, or the cannot simply be dismissed by Of®ce personnel as absence of a proven animal model for testing the being ªwrong,º even when there may be reason to effectiveness of drugs for treating a disorder in believe that the assertion is not entirely accurate. humans, should not, standing alone, serve as a basis Rather, Of®ce personnel must determine if the for challenging the asserted utility under 35 U.S.C. assertion of utility is credible (i.e., whether the 101. See MPEP § 2107.03 for additional guidance

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with regard to therapeutic or pharmacological Where the asserted utility is not speci®c or utilities. substantial, a prima facie showing must establish that it is more likely than not that a person of IV. INITIAL BURDEN IS ON THE OFFICE TO ordinary skill in the art would not consider that any ESTABLISH A PRIMA FACIE CASE AND utility asserted by the applicant would be speci®c PROVIDE EVIDENTIARY SUPPORT THEREOF and substantial. The prima facie showing must contain the following elements: To properly reject a claimed invention under 35 U.S.C. 101, the Of®ce must (A) make a prima (A) An explanation that clearly sets forth the facie showing that the claimed invention lacks utility, reasoning used in concluding that the asserted utility and (B) provide a suf®cient evidentiary basis for for the claimed invention is neither both speci®c and factual assumptions relied upon in establishing the substantial nor well-established; prima facie showing. In re Gaubert, 524 F.2d 1222, (B) Support for factual ®ndings relied upon in 1224, 187 USPQ 664, 666 (CCPA 1975) reaching this conclusion; and "Accordingly, the PTO must do more than merely question operability - it must set forth factual reasons (C) An evaluation of all relevant evidence of which would lead one skilled in the art to question record, including utilities taught in the closest prior the objective truth of the statement of operability." art. If the Of®ce cannot develop a proper prima facie Where the asserted speci®c and substantial utility is case and provide evidentiary support for a rejection not credible, a prima facie showing of no speci®c under 35 U.S.C. 101, a rejection on this ground and substantial credible utility must establish that it should not be imposed. See, e.g., In re Oetiker, 977 is more likely than not that a person skilled in the F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. art would not consider credible any speci®c and 1992) (ª[T]he examiner bears the initial burden, on substantial utility asserted by the applicant for the review of the prior art or on any other ground, of claimed invention. The prima facie showing must presenting a prima facie case of unpatentability. If contain the following elements: that burden is met, the burden of coming forward with evidence or argument shifts to the applicant.... (A) An explanation that clearly sets forth the If examination at the initial stage does not produce reasoning used in concluding that the asserted a prima facie case of unpatentability, then without speci®c and substantial utility is not credible; more the applicant is entitled to grant of the patent.º). See also Fregeau v. Mossinghoff, 776 F.2d 1034, (B) Support for factual ®ndings relied upon in 227 USPQ 848 (Fed. Cir. 1985) (applying prima reaching this conclusion; and facie case law to 35 U.S.C. 101); In re Piasecki, (C) An evaluation of all relevant evidence of 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984). record, including utilities taught in the closest prior art. The prima facie showing must be set forth in a Where no speci®c and substantial utility is disclosed well-reasoned statement. Any rejection based on or is well-established, a prima facie showing of no lack of utility should include a detailed explanation speci®c and substantial utility need only establish why the claimed invention has no speci®c and that applicant has not asserted a utility and that, on substantial credible utility. Whenever possible, the the record before the examiner, there is no known examiner should provide documentary evidence well-established utility. regardless of publication date (e.g., scienti®c or technical journals, excerpts from treatises or books, It is imperative that Of®ce personnel use speci®city or U.S. or foreign patents) to support the factual in setting forth and initial rejection under 35 U.S.C. basis for the prima facie showing of no speci®c and 101 and support any factual conclusions made in the substantial credible utility. If documentary evidence prima facie showing. is not available, the examiner should speci®cally explain the scienti®c basis for his or her factual conclusions. By using speci®city, the applicant will be able to identify the assumptions made by the Of®ce in

Rev. 07.2015, October 2015 2100-30 PATENTABILITY § 2107.02

setting forth the rejection and will be able to address Circuit recently noted, ª[o]nly after the PTO those assumptions properly. provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility V. EVIDENTIARY REQUESTS BY AN EXAMINER does the burden shift to the applicant to provide TO SUPPORT AN ASSERTED UTILITY rebuttal evidence suf®cient to convince such a person of the invention's asserted utility.º In re Brana, 51 In appropriate situations the Of®ce may require an F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995) (citing applicant to substantiate an asserted utility for a In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 claimed invention. See In re Pottier, 376 F.2d 328, (CCPA 1981)). In Brana, the court pointed out that 330, 153 USPQ 407, 408 (CCPA 1967) (ªWhen the the purpose of treating cancer with chemical operativeness of any process would be deemed compounds does not suggest, per se, an incredible unlikely by one of ordinary skill in the art, it is not utility. Where the prior art disclosed ªstructurally improper for the examiner to call for evidence of similar compounds to those claimed by applicants operativeness.º). See also In re Jolles, 628 F.2d which have been proven in vivo to be effective as 1322, 1327, 206 USPQ 885, 890 (CCPA 1980); In chemotherapeutic agents against various tumor re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA models . . ., one skilled in the art would be without 1963); In re Novak, 306 F.2d 924, 928, 134 USPQ basis to reasonably doubt applicants' asserted utility 335, 337 (CCPA1962). In In re Citron, the court on its face.º 51 F.3d at 1566, 34 USPQ2d at 1441. held that when an ªalleged utility appears to be As courts have stated, ªit is clearly improper for the incredible in the light of the knowledge of the art, examiner to make a demand for further test data, or factually misleading, applicant must establish the which as evidence would be essentially redundant asserted utility by acceptable proof.º 325 F.2d at and would seem to serve for nothing except perhaps 253, 139 USPQ at 520. The court approved of the to unduly burden the applicant.º In re Isaacs, 347 board's decision which af®rmed the rejection under F.2d 887, 890, 146 USPQ 193, 196 (CCPA 1965). 35 U.S.C. 101 ªin view of the art knowledge of the lack of a cure for cancer and the absence of any VI. CONSIDERATION OF A REPLY TO A PRIMA clinical data to substantiate the allegation.º 325 F.2d FACIE REJECTION FOR LACK OF UTILITY at 252, 139 USPQ at 519 (emphasis in original). The court thus established a higher burden on the If a rejection under 35 U.S.C. 101 has been properly applicant where the statement of use is incredible or imposed, along with a corresponding rejection under misleading. In such a case, the examiner should 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst challenge the use and require suf®cient evidence of paragraph, the burden shifts to the applicant to rebut operativeness. The purpose of this authority is to the prima facie showing. In re Oetiker, 977 F.2d enable an applicant to cure an otherwise defective 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992) factual basis for the operability of an invention. (ªThe examiner bears the initial burden, on review Because this is a curative authority (e.g., evidence of the prior art or on any other ground, of presenting is requested to enable an applicant to support an a prima facie case of unpatentability. If that burden assertion that is inconsistent with the facts of record is met, the burden of coming forward with evidence in the application), Of®ce personnel should indicate or argument shifts to the applicant. . . After evidence not only why the factual record is defective in or argument is submitted by the applicant in relation to the assertions of the applicant, but also, response, patentability is determined on the totality where appropriate, what type of evidentiary showing of the record, by a preponderance of evidence with can be provided by the applicant to remedy the due consideration to persuasiveness of argument.º). problem. An applicant can do this using any combination of the following: amendments to the claims, arguments Requests for additional evidence should be imposed or reasoning, or new evidence submitted in an rarely, and only if necessary to support the scienti®c af®davit or declaration under 37 CFR 1.132, or in a credibility of the asserted utility (e.g., if the asserted printed publication. New evidence provided by an utility is not consistent with the evidence of record applicant must be relevant to the issues raised in the and current scienti®c knowledge). As the Federal rejection. For example, declarations in which

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conclusions are set forth without establishing a nexus Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ between those conclusions and the supporting 881, 883-84 (CCPA 1980) (reversing the Board and evidence, or which merely express opinions, may rejecting Bowler's arguments that the evidence of be of limited probative value with regard to rebutting utility was statistically insigni®cant. The court a prima facie case. In re Grunwell, 609 F.2d 486, pointed out that a rigorous correlation is not 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 necessary when the test is reasonably predictive of F.2d 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See the response). See also Rey-Bellet v. Englehardt, MPEP § 716.01(a) through MPEP § 716.01(c). 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from animal testing is relevant to asserted human If the applicant responds to the prima facie rejection, therapeutic utility if there is a ªsatisfactory Of®ce personnel should review the original correlation between the effect on the animal and that disclosure, any evidence relied upon in establishing ultimately observed in human beingsº). Instead, the prima facie showing, any claim amendments, evidence will be suf®cient if, considered as a whole, and any new reasoning or evidence provided by the it leads a person of ordinary skill in the art to applicant in support of an asserted speci®c and conclude that the asserted utility is more likely than substantial credible utility. It is essential for Of®ce not true. personnel to recognize, fully consider and respond to each substantive element of any response to a 2107.03 Special Considerations for Asserted rejection based on lack of utility. Only where the Therapeutic or Pharmacological Utilities totality of the record continues to show that the [R-08.2012] asserted utility is not speci®c, substantial, and credible should a rejection based on lack of utility The federal courts have consistently reversed be maintained. If the record as a whole would make rejections by the Of®ce asserting a lack of utility for it more likely than not that the asserted utility for inventions claiming a pharmacological or therapeutic the claimed invention would be considered credible utility where an applicant has provided evidence that by a person of ordinary skill in the art, the Of®ce reasonably supports such a utility. In view of this, cannot maintain the rejection. In re Rinehart, 531 Of®ce personnel should be particularly careful in F.2d 1048, 1052, 189 USPQ 143, 147 (CCPA 1976). their review of evidence provided in support of an asserted therapeutic or pharmacological utility. VII. EVALUATION OF EVIDENCE RELATED TO UTILITY I. A REASONABLE CORRELATION BETWEEN THE EVIDENCE AND THE ASSERTED UTILITY There is no predetermined amount or character of IS SUFFICIENT evidence that must be provided by an applicant to support an asserted utility, therapeutic or otherwise. As a general matter, evidence of pharmacological Rather, the character and amount of evidence needed or other biological activity of a compound will be to support an asserted utility will vary depending on relevant to an asserted therapeutic use if there is a what is claimed (Ex parte Ferguson, 117 USPQ 229 reasonable correlation between the activity in (Bd. App. 1957)), and whether the asserted utility question and the asserted utility. Cross v. Iizuka, appears to contravene established scienti®c 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In principles and beliefs. In re Gazave, 379 F.2d 973, re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 978, 154 USPQ 92, 96 (CCPA 1967); In re 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 881 (CCPA 1980). An applicant can establish this (CCPA 1956). Furthermore, the applicant does not reasonable correlation by relying on statistically have to provide evidence suf®cient to establish that relevant data documenting the activity of a an asserted utility is true ªbeyond a reasonable compound or composition, arguments or reasoning, doubt.º In re Irons, 340 F.2d 974, 978, 144 USPQ documentary evidence (e.g., articles in scienti®c 351, 354 (CCPA 1965). Nor must an applicant journals), or any combination thereof. The applicant provide evidence such that it establishes an asserted does not have to prove that a correlation exists utility as a matter of statistical certainty. between a particular activity and an asserted

Rev. 07.2015, October 2015 2100-32 PATENTABILITY § 2107.03

therapeutic use of a compound as a matter of not particularly receptive to rejections under 35 statistical certainty, nor does he or she have to U.S.C. 101 based on inoperability. Most striking is provide actual evidence of success in treating the fact that in those cases where an applicant humans where such a utility is asserted. Instead, as supplied a reasonable evidentiary showing the courts have repeatedly held, all that is required supporting an asserted therapeutic utility, almost is a reasonable correlation between the activity and uniformly the 35 U.S.C. 101-based rejection was the asserted use. Nelson v. Bowler, 626 F.2d 853, reversed. See, e.g., In re Brana, 51 F.3d 1560, 34 857, 206 USPQ 881, 884 (CCPA 1980). USPQ 1436 (Fed. Cir. 1995); Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re II. STRUCTURAL SIMILARITY TO COMPOUNDS Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); WITH ESTABLISHED UTILITY Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980); In re Malachowski, 530 Courts have routinely found evidence of structural F.2d 1402, 189 USPQ 432 (CCPA 1976); In re similarity to a compound known to have a particular Gaubert, 530 F.2d 1402, 189 USPQ 432 (CCPA therapeutic or pharmacological utility as being 1975); In re Gazave, 379 F.2d 973, 154 USPQ 92 supportive of an assertion of therapeutic utility for (CCPA 1967); In re Hartop, 311 F.2d 249, 135 a new compound. In In re Jolles, 628 F.2d 1322, USPQ 419 (CCPA 1962); In re Krimmel, 292 F.2d 206 USPQ 885 (CCPA 1980), the claimed 948, 130 USPQ 215 (CCPA 1961). Only in those compounds were found to have utility based on a cases where the applicant was unable to come ®nding of a close structural relationship to forward with any relevant evidence to rebut a ®nding daunorubicin and doxorubicin and shared by the Of®ce that the claimed invention was pharmacological activity with those compounds, inoperative was a 35 U.S.C. 101 rejection af®rmed both of which were known to be useful in cancer by the court. In re Citron, 325 F.2d 248, 253, 139 chemotherapy. The evidence of close structural USPQ 516, 520 (CCPA 1963) (therapeutic utility similarity with the known compounds was presented for an uncharacterized biological extract not in conjunction with evidence demonstrating supported or scienti®cally credible); In re Buting, substantial activity of the claimed compounds in 418 F.2d 540, 543, 163 USPQ 689, 690 (CCPA animals customarily employed for screening 1969) (record did not establish a credible basis for anticancer agents. Such evidence should be given the assertion that the single class of compounds in appropriate weight in determining whether one question would be useful in treating disparate types skilled in the art would ®nd the asserted utility of cancers); In re Novak, 306 F.2d 924, 134 USPQ credible. Of®ce personnel should evaluate not only 335 (CCPA 1962) (claimed compounds did not have the existence of the structural relationship, but also capacity to effect physiological activity upon which the reasoning used by the applicant or a declarant to utility claim based). Contrast, however, In re Buting explain why that structural similarity is believed to to In re Gardner, 475 F.2d 1389, 177 USPQ 396 be relevant to the applicant©s assertion of utility. (CCPA 1973), reh©g denied, 480 F.2d 879 (CCPA 1973), in which the court held that utility for a genus III. DATA FROM IN VITRO OR ANIMAL was found to be supported through a showing of TESTING IS GENERALLY SUFFICIENT TO utility for one species. In no case has a federal court SUPPORT THERAPEUTIC UTILITY required an applicant to support an asserted utility with data from human clinical trials. If reasonably correlated to the particular therapeutic or pharmacological utility, data generated using in If an applicant provides data, whether from in vitro vitro assays, or from testing in an animal model or assays or animal tests or both, to support an asserted a combination thereof almost invariably will be utility, and an explanation of why that data supports suf®cient to establish therapeutic or pharmacological the asserted utility, the Of®ce will determine if the utility for a compound, composition or process. A data and the explanation would be viewed by one cursory review of cases involving therapeutic skilled in the art as being reasonably predictive of inventions where 35 U.S.C. 101 was the dispositive the asserted utility. See, e.g., Ex parte Maas, 9 issue illustrates the fact that the federal courts are USPQ2d 1746 (Bd. Pat. App. & Inter. 1987); Ex

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parte Balzarini, 21 USPQ2d 1892 (Bd. Pat. App. & done clearly is not, in itself, a suf®cient basis for Inter. 1991). Of®ce personnel must be careful to rejecting all applications purporting to disclose how evaluate all factors that might in¯uence the to do it.º). conclusions of a person of ordinary skill in the art as to this question, including the test parameters, IV. HUMAN CLINICAL DATA choice of animal, relationship of the activity to the particular disorder to be treated, characteristics of Of®ce personnel should not impose on applicants the compound or composition, relative signi®cance the unnecessary burden of providing evidence from of the data provided and, most importantly, the human clinical trials. There is no decisional law that explanation offered by the applicant as to why the requires an applicant to provide data from human information provided is believed to support the clinical trials to establish utility for an invention asserted utility. If the data supplied is consistent with related to treatment of human disorders (see In re the asserted utility, the Of®ce cannot maintain a Isaacs, 347 F.2d 889, 146 USPQ 193 (CCPA 1963); rejection under 35 U.S.C. 101. In re Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974)), even with respect to situations where no Evidence does not have to be in the form of data art-recognized animal models existed for the human from an art-recognized animal model for the disease encompassed by the claims. Ex parte particular disease or disease condition to which the Balzarini, 21 USPQ2d 1892 (Bd. Pat. App. & Inter. asserted utility relates. Data from any test that the 1991) (human clinical data is not required to applicant reasonably correlates to the asserted utility demonstrate the utility of the claimed invention, even should be evaluated substantively. Thus, an applicant though those skilled in the art might not accept other may provide data generated using a particular animal evidence to establish the ef®cacy of the claimed model with an appropriate explanation as to why therapeutic compositions and the operativeness of that data supports the asserted utility. The absence the claimed methods of treating humans). Before a of a certi®cation that the test in question is an drug can enter human clinical trials, the sponsor, industry-accepted model is not dispositive of whether often the applicant, must provide a convincing data from an animal model is in fact relevant to the rationale to those especially skilled in the art (e.g., asserted utility. Thus, if one skilled in the art would the Food and Drug Administration (FDA)) that the accept the animal tests as being reasonably predictive investigation may be successful. Such a rationale of utility in humans, evidence from those tests should would provide a basis for the sponsor's expectation be considered suf®cient to support the credibility of that the investigation may be successful. In order to the asserted utility. In re Hartop, 311 F.2d 249, 135 determine a protocol for phase I testing, the ®rst USPQ 419 (CCPA 1962); In re Krimmel, 292 F.2d phase of clinical investigation, some credible 948, 953, 130 USPQ 215, 219 (CCPA 1961); Ex rationale of how the drug might be effective or could parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & be effective would be necessary. Thus, as a general Inter. 1986). Of®ce personnel should be careful not rule, if an applicant has initiated human clinical trials to ®nd evidence unpersuasive simply because no for a therapeutic product or process, Of®ce personnel animal model for the human disease condition had should presume that the applicant has established been established prior to the ®ling of the application. that the subject matter of that trial is reasonably See In re Chilowsky, 229 F.2d 457, 461, 108 USPQ predictive of having the asserted therapeutic utility. 321, 325 (CCPA 1956) (ªThe mere fact that something has not previously been done clearly is V. SAFETY AND EFFICACY CONSIDERATIONS not, in itself, a suf®cient basis for rejecting all applications purporting to disclose how to do it.º); The Of®ce must con®ne its review of patent In re Wooddy, 331 F.2d 636, 639, 141 USPQ 518, applications to the statutory requirements of the 520 (CCPA 1964) (ªIt appears that no one on earth patent law. Other agencies of the government have is certain as of the present whether the process been assigned the responsibility of ensuring claimed will operate in the manner claimed. Yet conformance to standards established by statute for absolute certainty is not required by the law. The the advertisement, use, sale or distribution of drugs. mere fact that something has not previously been The FDA pursues a two-prong test to provide

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approval for testing. Under that test, a sponsor must would be impossible. Such a determination has show that the investigation does not pose an always required a good understanding of the state unreasonable and signi®cant risk of illness or injury of the art as of the time that the invention was made. and that there is an acceptable rationale for the study. For example, prior to the 1980's, there were a As a review matter, there must be a rationale for number of cases where an asserted use in treating believing that the compound could be effective. If cancer in humans was viewed as ªincredible.º In re the use reviewed by the FDA is not set forth in the Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); speci®cation, FDA review may not satisfy 35 U.S.C. In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA 101. However, if the reviewed use is one set forth 1969); Ex parte Stevens, 16 USPQ2d 1379 (Bd. Pat. in the speci®cation, Of®ce personnel must App. & Inter. 1990); Ex parte Busse, 1 USPQ2d be extremely hesitant to challenge utility. In such a 1908 (Bd. Pat. App. & Inter. 1986); Ex parte situation, experts at the FDA have assessed the Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter. rationale for the drug or research study upon which 1986); Ex parte Jovanovics, 211 USPQ 907 (Bd. an asserted utility is based and found it satisfactory. Pat. App. & Inter. 1981). The fact that there is no Thus, in challenging utility, Of®ce personnel must known cure for a disease, however, cannot serve as be able to carry their burden that there is no sound the basis for a conclusion that such an invention rationale for the asserted utility even though experts lacks utility. Rather, Of®ce personnel must designated by Congress to decide the issue have determine if the asserted utility for the invention is come to an opposite conclusion. ªFDA approval, credible based on the information disclosed in the however, is not a prerequisite for ®nding a application. Only those claims for which an asserted compound useful within the meaning of the patent utility is not credible should be rejected. In such laws.º In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 cases, the Of®ce should carefully review what is (Fed. Cir. 1995) (citing Scott v. Finney, 34 F.3d being claimed by the applicant. An assertion that the 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. claimed invention is useful in treating a symptom 1994)). of an incurable disease may be considered credible by a person of ordinary skill in the art on the basis Thus, while an applicant may on occasion need to of a fairly modest amount of evidence or support. provide evidence to show that an invention will work In contrast, an assertion that the claimed invention as claimed, it is improper for Of®ce personnel to will be useful in ªcuringº the disease may require a request evidence of safety in the treatment of signi®cantly greater amount of evidentiary support humans, or regarding the degree of effectiveness. to be considered credible by a person of ordinary See In re Sichert, 566 F.2d 1154, 196 USPQ 209 skill in the art. In re Sichert, 566 F.2d 1154, 196 (CCPA 1977); In re Hartop, 311 F.2d 249, 135 USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d USPQ 419 (CCPA 1962); In re Anthony, 414 F.2d 1322, 206 USPQ 885 (CCPA 1980). See also Ex 1383, 162 USPQ 594 (CCPA 1969); In re Watson, parte Ferguson, 117 USPQ 229 (Bd. Pat. App. & 517 F.2d 465, 186 USPQ 11 (CCPA 1975); In re Inter. 1957). Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961); Ex parte Jovanovics, 211 USPQ 907 (Bd. In these cases, it is important to note that the Food Pat. App. & Inter. 1981). and Drug Administration has promulgated regulations that enable a party to conduct clinical VI. TREATMENT OF SPECIFIC DISEASE trials for drugs used to treat life threatening and CONDITIONS severely-debilitating illnesses, even where no alternative therapy exists. See 21 CFR 312.80-88 Claims directed to a method of treating or curing a (1994). Implicit in these regulations is the disease for which there have been no previously recognition that experts quali®ed to evaluate the successful treatments or cures warrant careful review effectiveness of therapeutics can and often do ®nd for compliance with 35 U.S.C. 101. The credibility a suf®cient basis to conduct clinical trials of drugs of an asserted utility for treating a human disorder for incurable or previously untreatable illnesses. may be more dif®cult to establish where current Thus, af®davit evidence from experts in the art scienti®c understanding suggests that such a task indicating that there is a reasonable expectation of

2100-35 Rev. 07.2015, October 2015 § 2108 MANUAL OF PATENT EXAMINING PROCEDURE -2110 success, supported by sound reasoning, usually infringement and validity, and can be interpreted should be suf®cient to establish that such a utility is based on a fully developed prosecution record. In credible. contrast, an examiner must construe claim terms in the broadest reasonable manner during prosecution 2108 as is reasonably allowed in an effort to establish a -2110 [Reserved] clear record of what applicant intends to claim. Thus, the Of®ce does not interpret claims in the same manner as the courts. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997); In 2111 Claim Interpretation; Broadest re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, Reasonable Interpretation [R-07.2015] 1321-22 (Fed. Cir. 1989).

CLAIMS MUST BE GIVEN THEIR BROADEST Because applicant has the opportunity to amend the REASONABLE INTERPRETATION IN LIGHT OF THE SPECIFICATION claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more During patent examination, the pending claims must broadly than is justi®ed. In re Yamamoto, 740 F.2d be ªgiven their broadest reasonable interpretation 1569, 1571 (Fed. Cir. 1984); In re Zletz, 893 F.2d consistent with the speci®cation.º The Federal 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) Circuit's en banc decision in Phillips v. AWH (ªDuring patent examination the pending claims Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 must be interpreted as broadly as their terms (Fed. Cir. 2005) expressly recognized that the reasonably allow.º); In re Prater, 415 F.2d 1393, USPTO employs the ªbroadest reasonable 1404-05, 162 USPQ 541, 550-51 (CCPA 1969) interpretationº standard: (Claim 9 was directed to a process of analyzing data generated by mass spectrographic analysis of a gas. The Patent and Trademark Of®ce (ªPTOº) The process comprised selecting the data to be determines the scope of claims in patent analyzed by subjecting the data to a mathematical applications not solely on the basis of the claim manipulation. The examiner made rejections under language, but upon giving claims their broadest 35 U.S.C. 101 and 35 U.S.C. 102. In the 35 U.S.C. reasonable construction ªin light of the 102 rejection, the examiner explained that the claim speci®cation as it would be interpreted by one was anticipated by a mental process augmented by of ordinary skill in the art.º In re Am. Acad. of pencil and paper markings. The court agreed that Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 the claim was not limited to using a machine to carry USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, out the process since the claim did not explicitly set the rules of the PTO require that application forth the machine. The court explained that ªreading claims must ªconform to the invention as set a claim in light of the speci®cation, to thereby forth in the remainder of the speci®cation and interpret limitations explicitly recited in the claim, the terms and phrases used in the claims must is a quite different thing from `reading limitations ®nd clear support or antecedent basis in the of the speci®cation into a claim,' to thereby narrow description so that the meaning of the terms in the scope of the claim by implicitly adding disclosed the claims may be ascertainable by reference limitations which have no express basis in the to the description.º 37 CFR 1.75(d)(1). claim.º The court found that applicant was advocating the latter, i.e., the impermissible See also In re Suitco Surface, Inc., 603 F.3d 1255, importation of subject matter from the speci®cation 1259, 94 USPQ2d 1640, 1643 (Fed. Cir. 2010); In into the claim.). See also In re Morris, 127 F.3d re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. 1667 (Fed. Cir. 2000). Cir. 1997) (The court held that the PTO is not required, in the course of prosecution, to interpret Patented claims are not given the broadest reasonable claims in applications in the same manner as a court interpretation during court proceedings involving would interpret claims in an infringement suit.

Rev. 07.2015, October 2015 2100-36 PATENTABILITY § 2111.01

Rather, the ªPTO applies to verbiage of the proposed See MPEP § 2173.02 for further discussion of claim claims the broadest reasonable meaning of the words interpretation in the context of analyzing claims for in their ordinary usage as they would be understood compliance with 35 U.S.C. 112(b) or pre-AIA 35 by one of ordinary skill in the art, taking into account U.S.C. 112, second paragraph. whatever enlightenment by way of de®nitions or otherwise that may be afforded by the written 2111.01 Plain Meaning [R-07.2015] description contained in applicant's speci®cation.º). [Editor Note: This MPEP section is applicable to The broadest reasonable interpretation does not mean applications subject to the ®rst inventor to ®le the broadest possible interpretation. Rather, the (FITF) provisions of the AIA except that the relevant meaning given to a claim term must be consistent date is the "effective ®ling date" of the claimed with the ordinary and customary meaning of the term invention instead of the "time of the invention," (unless the term has been given a special de®nition which is only applicable to applications subject to in the speci®cation), and must be consistent with the pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) use of the claim term in the speci®cation and and MPEP § 2150 et seq.] drawings. Further, the broadest reasonable interpretation of the claims must be consistent with I. THE WORDS OF A CLAIM MUST BE GIVEN the interpretation that those skilled in the art would THEIR ªPLAIN MEANINGº UNLESS SUCH reach. In re Cortright, 165 F.3d 1353, 1359, 49 MEANING IS INCONSISTENT WITH THE USPQ2d 1464, 1468 (Fed. Cir. 1999) (The Board's SPECIFICATION construction of the claim limitation ªrestore hair growthº as requiring the hair to be returned to its Under a broadest reasonable interpretation, words original state was held to be an incorrect of the claim must be given their plain meaning, interpretation of the limitation. The court held that, unless such meaning is inconsistent with the consistent with applicant's disclosure and the speci®cation. The plain meaning of a term means disclosure of three patents from analogous arts using the ordinary and customary meaning given to the the same phrase to require only some increase in term by those of ordinary skill in the art at the time hair growth, one of ordinary skill would construe of the invention. The ordinary and customary ªrestore hair growthº to mean that the claimed meaning of a term may be evidenced by a variety of method increases the amount of hair grown on the sources, including the words of the claims scalp, but does not necessarily produce a full head themselves, the speci®cation, drawings, and prior of hair.). Thus the focus of the inquiry regarding the art. However, the best source for determining the meaning of a claim should be what would be meaning of a claim term is the speci®cation - the reasonable from the perspective of one of ordinary greatest clarity is obtained when the speci®cation skill in the art. In re Suitco Surface, Inc., 603 F.3d serves as a glossary for the claim terms. The words 1255, 1260, 94 USPQ2d 1640, 1644 (Fed. Cir. of the claim must be given their plain meaning unless 2010); In re Buszard, 504 F.3d 1364, 84 USPQ2d the plain meaning is inconsistent with the 1749 (Fed. Cir. 2007). In Buszard, the claim was speci®cation. In re Zletz, 893 F.2d 319, 321, 13 directed to a ¯ame retardant composition comprising USPQ2d 1320, 1322 (Fed. Cir. 1989) (discussed a ¯exible polyurethane foam reaction mixture. 504 below); Chef America, Inc. v. Lamb-Weston, Inc., F.3d at 1365, 84 USPQ2d at 1750. The Federal 358 F.3d 1371, 1372, 69 USPQ2d 1857 (Fed. Cir. Circuit found that the Board's interpretation that 2004) (Ordinary, simple English words whose equated a ª¯exibleº foam with a crushed ªrigidº meaning is clear and unquestionable, absent any foam was not reasonable. Id. at 1367, 84 USPQ2d indication that their use in a particular context at 1751. Persuasive argument was presented that changes their meaning, are construed to mean exactly persons experienced in the ®eld of polyurethane what they say. Thus, ªheating the resulting foams know that a ¯exible mixture is different than batter-coated dough to a temperature in the range of a rigid foam mixture. Id. at 1366, 84 USPQ2d at about 400oF to 850oFº required heating the dough, 1751. rather than the air inside an oven, to the speci®ed temperature.).

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The presumption that a term is given its ordinary Symantec Corp., 318 F.3d 1363, 1371, 65 USPQ2d and customary meaning may be rebutted by the 1865, 1869-70 (Fed. Cir. 2003) (Although the applicant by clearly setting forth a different speci®cation discussed only a single embodiment, de®nition of the term in the speci®cation. In re the court held that it was improper to read a speci®c Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, order of steps into method claims where, as a matter 1028 (Fed. Cir. 1997) (the USPTO looks to the of logic or grammar, the language of the method ordinary use of the claim terms taking into account claims did not impose a speci®c order on the de®nitions or other ªenlightenmentº contained in performance of the method steps, and the the written description); But c.f. In re Am. Acad. of speci®cation did not directly or implicitly require a Sci. Tech. Ctr., 367 F.3d 1359, 1369, 70 USPQ2d particular order). See also subsection IV., below. 1827, 1834 (Fed. Cir. 2004) (ªWe have cautioned When an element is claimed using language falling against reading limitations into a claim from the under the scope of 35 U.S.C. 112(f) or pre-AIA preferred embodiment described in the speci®cation, 35 U.S.C. 112, 6th paragraph (often broadly referred even if it is the only embodiment described, absent to as means- (or step-) plus- function language), the clear disclaimer in the speci®cation.º). When the speci®cation must be consulted to determine the speci®cation sets a clear path to the claim language, structure, material, or acts corresponding to the the scope of the claims is more easily determined function recited in the claim, and the claimed and the public notice function of the claims is best element is construed as limited to the corresponding served. structure, material, or acts described in the speci®cation and equivalents thereof. In re Donaldson, 16 F.3d 1189, 29 USPQ2d 1845 (Fed. II. IT IS IMPROPER TO IMPORT CLAIM Cir. 1994) (see MPEP § 2181- MPEP § 2186). LIMITATIONS FROM THE SPECIFICATION In Zletz, supra, the examiner and the Board had ªThough understanding the claim language may be interpreted claims reading ªnormally solid aided by explanations contained in the written polypropyleneº and ªnormally solid polypropylene description, it is important not to import into a claim having a crystalline polypropylene contentº as being limitations that are not part of the claim. For limited to ªnormally solid linear high homopolymers example, a particular embodiment appearing in the of propylene which have a crystalline polypropylene written description may not be read into a claim content.º The court ruled that limitations, not present when the claim language is broader than the in the claims, were improperly imported from the embodiment.º Superguide Corp. v. DirecTV speci®cation. See also In re Marosi, 710 F.2d 799, Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 802, 218 USPQ 289, 292 (Fed. Cir. 1983) (ª©[C]laims 1865, 1868 (Fed. Cir. 2004). See also are not to be read in a vacuum, and limitations Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, therein are to be interpreted in light of the 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) speci®cation in giving them their `broadest (discussing recent cases wherein the court expressly reasonable interpretation.©º (quoting In re Okuzawa, rejected the contention that if a patent describes only 537 F.2d 545, 548, 190 USPQ 464, 466 (CCPA a single embodiment, the claims of the patent must 1976)). The court looked to the speci®cation to be construed as being limited to that embodiment); construe ªessentially free of alkali metalº as E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, including unavoidable levels of impurities but no 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) more.). (ªInterpretation of descriptive statements in a patent's written description is a dif®cult task, as an III. ªPLAIN MEANINGº REFERS TO THE inherent tension exists as to whether a statement is ORDINARY AND CUSTOMARY MEANING GIVEN a clear lexicographic de®nition or a description of TO THE TERM BY THOSE OF ORDINARY SKILL a preferred embodiment. The problem is to interpret IN THE ART claims `in view of the speci®cation' without unnecessarily importing limitations from the ª[T]he ordinary and customary meaning of a claim speci®cation into the claims.º); Altiris Inc. v. term is the meaning that the term would have to a

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person of ordinary skill in the art in question at the scope and content of a claim term, there is no need time of the invention, i.e., as of the effective ®ling to turn to extrinsic evidence for claim interpretation. date of the patent application.º Phillips v. AWH 3M Innovative Props. Co. v. Tredegar Corp., 725 Corp.,415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326 F.3d 1315, 1326-28, 107 USPQ2d 1717, 1726-27 (Fed. Cir. 2005) (en banc); Sunrace Roots Enter. (Fed. Cir. 2013) (holding that ªcontinuous Co. v. SRAM Corp., 336 F.3d 1298, 1302, 67 microtextured skin layer over substantially the entire USPQ2d 1438, 1441 (Fed. Cir. 2003); laminateº was clearly de®ned in the written Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., description, and therefore, there was no need to turn 334 F.3d 1294, 1298 67 USPQ2d 1132, 1136 (Fed. to extrinsic evidence to construe the claim). Cir. 2003) (ªIn the absence of an express intent to impart a novel meaning to the claim terms, the words IV. APPLICANT MAY BE OWN are presumed to take on the ordinary and customary LEXICOGRAPHER AND/OR MAY DISAVOW meanings attributed to them by those of ordinary CLAIM SCOPE skill in the art.º). The only exceptions to giving the words in a claim The ordinary and customary meaning of a term may their ordinary and customary meaning in the art are be evidenced by a variety of sources, including the (1) when the applicant acts as his own lexicographer; words of the claims themselves, the speci®cation, and (2) when the applicant disavows or disclaims drawings, and prior art. However, the best source the full scope of a claim term in the speci®cation. for determining the meaning of a claim term is the To act as his own lexicographer, the applicant must speci®cation ± the greatest clarity is obtained when clearly set forth a special de®nition of a claim term the speci®cation serves as a glossary for the claim in the speci®cation that differs from the plain and terms. See, e.g., In re Abbott Diabetes Care Inc., ordinary meaning it would otherwise possess. The 696 F.3d 1142, 1149-50, 104 USPQ2d 1337, speci®cation may also include an intentional 1342-43 (Fed. Cir. 2012) (construing the term disclaimer, or disavowal, of claim scope. In both of ªelectrochemical sensorº as ªdevoid of external these cases, ªthe inventor's intention, as expressed connection cables or wires to connect to a sensor in the speci®cation, is regarded as dispositive.º control unitº to be consistent with ªthe language of Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. the claims and the speci®cationº); In re Suitco Cir. 2005) (en banc). See also Starhome GmbH v. Surface, Inc., 603 F.3d 1255, 1260-61, 94 USPQ2d AT&T Mobility LLC, 743 F.3d 849, 857, 109 1640, 1644 (Fed. Cir. 2010) (construing the term USPQ2d 1885, 1890-91 (Fed. Cir. 2014) (holding ªmaterial for ®nishing the top surface of the ¯oorº that the term ªgatewayº should be given its ordinary to mean ªa clear, uniform layer on the top surface and customary meaning of ªa connection between of a ¯oor that is the ®nal treatment or coating of a different networksº because nothing in the surfaceº to be consistent with ªthe express language speci®cation indicated a clear intent to depart from of the claim and the speci®cationº); Vitronics Corp. that ordinary meaning); Thorner v. Sony Computer v. Conceptronic Inc., 90 F.3d 1576, 1583, 39 Entm't Am. LLC, 669 F.3d 1362, 1367-68, 101 USPQ2d 1573, 1577 (Fed. Cir. 1996) (construing USPQ2d 1457, 1460 (Fed. Cir. 2012) (The asserted the term ªsolder re¯ow temperatureº to mean ªpeak claims of the patent were directed to a tactile re¯ow temperatureº of solder rather than the feedback system for video game controllers ªliquidus temperatureº of solder in order to remain comprising a ¯exible pad with a plurality of consistent with the speci®cation). actuators ªattached to said pad.º The court held that the claims were not limited to actuators attached to It is also appropriate to look to how the claim term the external surface of the pad, even though the is used in the prior art, which includes prior art speci®cation used the word ªattachedº when patents, published applications, trade publications, describing embodiments af®xed to the external and dictionaries. Any meaning of a claim term taken surface of the pad but the word ªembeddedº when from the prior art must be consistent with the use of describing embodiments af®xed to the internal the claim term in the speci®cation and drawings. surface of the pad. The court explained that the plain Moreover , when the speci®cation is clear about the and ordinary meaning of ªattachedº includes both

2100-39 Rev. 07.2015, October 2015 § 2111.01 MANUAL OF PATENT EXAMINING PROCEDURE

external and internal attachments. Further, there is However, it is important to note that any special no clear and explicit statement in the speci®cation meaning assigned to a term ªmust be suf®ciently to rede®ne ªattachedº or disavow the full scope of clear in the speci®cation that any departure from the term.) common usage would be so understood by a person of experience in the ®eld of the invention.º A. Lexicography Multiform Desiccants Inc. v. Medzam Ltd., 133 F.3d 1473, 1477, 45 USPQ2d 1429, 1432 (Fed. Cir. An applicant is entitled to be his or her own 1998). See also Process Control Corp. v. lexicographer and may rebut the presumption that HydReclaim Corp., 190 F.3d 1350, 1357, claim terms are to be given their ordinary and 52 USPQ2d 1029, 1033 (Fed. Cir. 1999) and MPEP customary meaning by clearly setting forth a § 2173.05(a). de®nition of the term that is different from its ordinary and customary meaning(s) in the In some cases, the meaning of a particular claim speci®cation at the time of ®ling. See In re Paulsen, term may be de®ned by implication, that is, 30 F.3d 1475, 1480, 31 USPQ2d 1671, 1674 (Fed. according to the usage of the term in the context in Cir. 1994) (holding that an inventor may de®ne the speci®cation. See Phillips v. AWH Corp., 415 speci®c terms used to describe invention, but must F.3d 1303, 1320-21, 75 USPQ2d 1321, 1332 (Fed. do so ªwith reasonable clarity, deliberateness, and Cir. 2005) (en banc); Vitronics Corp. v. precisionº and, if done, must ª`set out his uncommon Conceptronic Inc., 90 F.3d 1576, 1583, 39 USPQ2d de®nition in some manner within the patent 1573, 1577 (Fed. Cir. 1996). But where the disclosure' so as to give one of ordinary skill in the speci®cation is ambiguous as to whether the inventor art notice of the changeº in meaning) (quoting used claim terms inconsistent with their ordinary Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d meaning, the ordinary meaning will apply. Merck 1384, 1387-88, 21 USPQ2d 1383, 1386 (Fed. Cir. & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1992)). 1370 (Fed. Cir. 2005) (The Federal Circuit reversed the district court's construction of the claim term Where an explicit de®nition is provided by the ªaboutº as ªexactly.º The appellate court explained applicant for a term, that de®nition will control that a passage in the speci®cation the district court interpretation of the term as it is used in the claim. relied upon for the de®nition of ªaboutº was too Toro Co. v. White Consolidated Industries Inc., 199 ambiguous to rede®ne ªaboutº to mean ªexactlyº in F.3d 1295, 1301, 53 USPQ2d 1065, 1069 (Fed. Cir. clear enough terms. The appellate court held that 1999) (meaning of words used in a claim is not ªaboutº should instead be given its plain and construed in a ªlexicographic vacuum, but in the ordinary meaning of ªapproximately.º). context of the speci®cation and drawingsº). Thus, if a claim term is used in its ordinary and customary B. Disavowal meaning throughout the speci®cation, and the written description clearly indicates its meaning, then the Applicant may also rebut the presumption of plain term in the claim has that meaning. Old Town Canoe meaning by clearly disavowing the full scope of the Co. v. Con¯uence Holdings Corp., 448 F.3d 1309, claim term in the speci®cation. Disavowal, or 1317, 78 USPQ2d 1705, 1711 (Fed. Cir. 2006) (The disclaimer of claim scope, is only considered when court held that ªcompletion of coalescenceº must be it is clear and unmistakable. See SciMed Life Sys., given its ordinary and customary meaning of Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d reaching the end of coalescence. The court explained 1337, 1341 (Fed.Cir.2001) (ªWhere the speci®cation that even though coalescence could theoretically be makes clear that the invention does not include a ªcompletedº by halting the molding process earlier, particular feature, that feature is deemed to be the speci®cation clearly intended that completion of outside the reach of the claims of the patent, even coalescence occurs only after the molding process though the language of the claims, read without reaches its optimum stage.) reference to the speci®cation, might be considered broad enough to encompass the feature in question.º); see also In re Am. Acad. Of Sci. Tech

Rev. 07.2015, October 2015 2100-40 PATENTABILITY § 2111.01

Ctr., 367 F.3d 1359, 1365-67 (Fed. Cir. 2004) whether plain meaning applies or a special de®nition (refusing the limit claim term ªuser computerº to applies. only ªsingle-user computersº even though ªsome of the language of the speci®cation, when viewed in The ®rst question is to determine whether a claim isolation, might lead a reader to conclude that the term has an ordinary and customary meaning to those term . . . is meant to refer to a computer that serves of ordinary skill in the art. If so, then the examiner only a single user, the speci®cation as a whole should check the speci®cation to determine whether suggests a construction that is not so narrowº). But, it provides a special de®nition for the claim term. If in some cases, disavowal of a broader claim scope the speci®cation does not provide a special de®nition may be made by implication, such as where the for the claim term, the examiner should apply the speci®cation contains only disparaging remarks with ordinary and customary meaning to the claim term. respect to a feature and every embodiment in the If the speci®cation provides a special de®nition for speci®cation excludes that feature. In re Abbott the claim term, the examiner should use the special Diabetes Care Inc., 696 F.3d 1142, 1149-50, 104 de®nition. However, because there is a presumption USPQ2d 1337, 1342-43 (Fed. Cir. 2012) (holding that claim terms have their ordinary and customary that the broadest reasonable interpretation of the meaning and the speci®cation must provide a clear claim term ªelectrochemical sensorº does not include and intentional use of a special de®nition for the a sensor having ªexternal connection cables or wiresº claim term to be treated as having a special because the speci®cation ªrepeatedly, consistently, de®nition, an Of®ce action should acknowledge and and exclusively depict[s] an electrochemical sensor identify the special de®nition in this situation. without external cables or wires while simultaneously disparaging sensors with external Moving back to the ®rst question, if a claim term cables or wiresº). If the examiner believes that the does not have an ordinary and customary meaning, broadest reasonable interpretation of a claim is the examiner should check the speci®cation to narrower than what the words of the claim otherwise determine whether it provides a meaning to the claim suggest as the result of implicit disavowal in the term. If no reasonably clear meaning can be ascribed speci®cation, then the examiner should make his or to the claim term after considering the speci®cation her interpretation clear on the record. and prior art, the examiner should apply the broadest reasonable interpretation to the claim term as it can See also MPEP § 2173.05(a). be best understood. Also, the claim should be rejected under 35 U.S.C. 112(b) and the speci®cation V. Summary of determining the meaning of a claim objected to under 37 CFR 1.75(d). term that does not invoke 35 U.S.C. 112(f ) If the speci®cation provides a meaning for the claim This ¯ow chart indicates the decisions an examiner term, the examiner should use the meaning provided would follow in order to ascertain the proper claim by the speci®cation. It may be appropriate for an interpretation based on the plain meaning de®nition Of®ce action to clarify the meaning acknowledge of BRI. With each decision in the ¯ow chart, a and identify the special de®nition in this situation. different path may need to be taken to conclude

2100-41 Rev. 07.2015, October 2015 § 2111.02 MANUAL OF PATENT EXAMINING PROCEDURE

2111.02 Effect of Preamble [R-08.2012] 1995). ªIf the claim preamble, when read in the context of the entire claim, recites limitations of the The determination of whether a preamble limits a claim, or, if the claim preamble is `necessary to give claim is made on a case-by-case basis in light of the life, meaning, and vitality' to the claim, then the facts in each case; there is no litmus test de®ning claim preamble should be construed as if in the when a preamble limits the scope of a claim. balance of the claim.º Pitney Bowes, Inc. v. Catalina Mktg. Int'l v. Coolsavings.com, Inc., 289 Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 F.3d 801, 808, 62 USPQ2d 1781, 1785 (Fed. Cir. USPQ2d 1161, 1165-66 (Fed. Cir. 1999). See also 2002). See id. at 808-10, 62 USPQ2d at 1784-86 Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, for a discussion of guideposts that have emerged 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In from various decisions exploring the preamble's considering the effect of the preamble in a claim effect on claim scope, as well as a hypothetical directed to a method of treating or preventing example illustrating these principles. pernicious anemia in humans by administering a certain vitamin preparation to ªa human in need ª[A] claim preamble has the import that the claim thereof,º the court held that the claims' recitation of as a whole suggests for it.º Bell Communications a patient or a human ªin needº gives life and Research, Inc. v. Vitalink Communications Corp., meaning to the preamble's statement of purpose.). 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed. Cir. Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478,

Rev. 07.2015, October 2015 2100-42 PATENTABILITY § 2111.02

481 (CCPA 1951) (A preamble reciting ª[a]n II. PREAMBLE STATEMENTS RECITING abrasive articleº was deemed essential to point out PURPOSE OR INTENDED USE the invention de®ned by claims to an article comprising abrasive grains and a hardened binder The claim preamble must be read in the context of and the process of making it. The court stated ªit is the entire claim. The determination of whether only by that phrase that it can be known that the preamble recitations are structural limitations or subject matter de®ned by the claims is comprised mere statements of purpose or use ªcan be resolved as an abrasive article. Every union of substances only on review of the entirety of the [record] to gain capable inter alia of use as abrasive grains and a an understanding of what the inventors actually binder is not an `abrasive article.'º Therefore, the invented and intended to encompass by the claim.º preamble served to further de®ne the structure of Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d the article produced.). at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed I. PREAMBLE STATEMENTS LIMITING invention, and the preamble merely states, for STRUCTURE example, the purpose or intended use of the invention, rather than any distinct de®nition of any Any terminology in the preamble that limits the of the claimed invention's limitations, then the structure of the claimed invention must be treated preamble is not considered a limitation and is of no as a claim limitation. See, e.g., Corning Glass Works signi®cance to claim construction. Pitney Bowes, v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also determination of whether preamble recitations are Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, structural limitations can be resolved only on review 1553 (Fed. Cir. 1997) (ªwhere a patentee de®nes a of the entirety of the application ªto gain an structurally complete invention in the claim body understanding of what the inventors actually and uses the preamble only to state a purpose or invented and intended to encompass by the claim.º); intended use for the invention, the preamble is not Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, a claim limitationº); Kropa v. Robie, 187 F.2d at 14 USPQ2d 1871, 1876 (Fed. Cir. 1990) 152, 88 USPQ2d at 480-81 (preamble is not a (determining that preamble language that constitutes limitation where claim is directed to a product and a structural limitation is actually part of the claimed the preamble merely recites a property inherent in invention). See also In re Stencel, 828 F.2d 751, 4 an old product de®ned by the remainder of the USPQ2d 1071 (Fed. Cir. 1987) (The claim at issue claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 was directed to a driver for setting a joint of a USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that threaded collar; however, the body of the claim did the preamble phrase ªwhich provides improved not directly include the structure of the collar as part playing and handling characteristicsº in a claim of the claimed article. The examiner did not consider drawn to a head for a lacrosse stick was not a claim the preamble, which did set forth the structure of the limitation). Compare Jansen v. Rexall Sundown, collar, as limiting the claim. The court found that Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, the collar structure could not be ignored. While the 1158 (Fed. Cir. 2003) (In a claim directed to a claim was not directly limited to the collar, the collar method of treating or preventing pernicious anemia structure recited in the preamble did limit the in humans by administering a certain vitamin structure of the driver. ª[T]he framework - the preparation to ªa human in need thereof,º the court teachings of the prior art - against which patentability held that the preamble is not merely a statement of is measured is not all drivers broadly, but drivers effect that may or may not be desired or appreciated, suitable for use in combination with this collar, for but rather is a statement of the intentional purpose the claims are so limited.º Id. at 1073, 828 F.2d at for which the method must be performed. Thus the 754.). claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); In re Cruciferous Sprout Litig., 301 F.3d

2100-43 Rev. 07.2015, October 2015 § 2111.02 MANUAL OF PATENT EXAMINING PROCEDURE

1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. a de®ciency of vitamin B12 or folic acid, involving Cir. 2002) (A claim at issue was directed to a method (i) assaying a body ¯uid for an ªelevated levelº of of preparing a food rich in glucosinolates wherein homocysteine, and (ii) ªcorrelatingº an ªelevatedº cruciferous sprouts are harvested prior to the 2-leaf level with a vitamin de®ciency. Id. at 1358-59, 71 stage. The court held that the preamble phrase ªrich USPQ2d at 1084. The court stated that the disputed in glucosinolatesº helps de®ne the claimed invention, claim term ªcorrelatingº can include comparing with as evidenced by the speci®cation and prosecution either an unelevated level or elevated level, as history, and thus is a limitation of the claim opposed to only an elevated level because adding (although the claim was anticipated by prior art that the ªcorrelatingº step in the claim during prosecution produced sprouts inherently ªrich in to overcome prior art tied the preamble directly to glucosinolatesº)). the ªcorrelatingº step. Id. at 1362, 71 USPQ2d at 1087. The recitation of the intended use of During examination, statements in the preamble ªdetectingº a vitamin de®ciency in the preamble reciting the purpose or intended use of the claimed rendered the claimed invention a method for invention must be evaluated to determine whether ªdetecting,º and, thus, was not limited to detecting the recited purpose or intended use results in a ªelevatedº levels. Id. structural difference (or, in the case of process claims, manipulative difference) between the claimed See also Catalina Mktg. Int'l, 289 F.3d at 808-09, invention and the prior art. If so, the recitation serves 62 USPQ2d at 1785 (ª[C]lear reliance on the to limit the claim. See, e.g., In re Otto, 312 F.2d preamble during prosecution to distinguish the 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claimed invention from the prior art transforms the claims were directed to a core member for hair preamble into a claim limitation because such curlers and a process of making a core member for reliance indicates use of the preamble to de®ne, in hair curlers. The court held that the intended use of part, the claimed invention.¼Without such reliance, hair curling was of no signi®cance to the structure however, a preamble generally is not limiting when and process of making.); In re Sinex, 309 F.2d 488, the claim body describes a structurally complete 492, 135 USPQ 302, 305 (CCPA 1962) (statement invention such that deletion of the preamble phrase of intended use in an apparatus claim did not does not affect the structure or steps of the claimed distinguish over the prior art apparatus). If a prior invention.º Consequently, ªpreamble language art structure is capable of performing the intended merely extolling bene®ts or features of the claimed use as recited in the preamble, then it meets the invention does not limit the claim scope without claim. See, e.g., In re Schreiber, 128 F.3d 1473, clear reliance on those bene®ts or features as 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) patentably signi®cant.º). In Poly-America LP v. (anticipation rejection af®rmed based on Board's GSE Lining Tech. Inc., 383 F.3d 1303, 1310, 72 factual ®nding that the reference dispenser (a spout USPQ2d 1685, 1689 (Fed. Cir. 2004), the court disclosed as useful for purposes such as dispensing stated that ªa `[r]eview of the entirety of the '047 oil from an oil can) would be capable of dispensing patent reveals that the preamble language relating popcorn in the manner set forth in appellant's claim to `blown-®lm' does not state a purpose or an 1 (a dispensing top for dispensing popcorn in a intended use of the invention, but rather discloses a speci®ed manner)) and cases cited therein. See also fundamental characteristic of the claimed invention MPEP § 2112 - MPEP § 2112.02. that is properly construed as a limitation of the claim.'º Compare Intirtool, Ltd. v. Texar Corp., 369 However, a ªpreamble may provide context for claim F.3d 1289, 1294-96, 70 USPQ2d 1780, 1783-84 construction, particularly, where ¼ that preamble's (Fed. Cir. 2004) (holding that the preamble of a statement of intended use forms the basis for patent claim directed to a ªhand-held punch pliers distinguishing the prior art in the patent's prosecution for simultaneously punching and connecting history.º Metabolite Labs., Inc. v. Corp. of Am. overlapping sheet metalº was not a limitation of the Holdings, 370 F.3d 1354, 1358-62, 71 USPQ2d claim because (i) the body of the claim described a 1081, 1084-87 (Fed. Cir. 2004). The patent claim at ªstructurally complete inventionº without the issue was directed to a two-step method for detecting preamble, and (ii) statements in prosecution history

Rev. 07.2015, October 2015 2100-44 PATENTABILITY § 2111.03

referring to ªpunching and connectingº function of open-ended.º Id. In contrast, the court noted the invention did not constitute ªclear relianceº on the phrase ªgroup consisting ofº is a closed term, which preamble needed to make the preamble a limitation). is often used in claim drafting to signal a ªMarkush groupº that is by its nature closed. Id. The court also 2111.03 Transitional Phrases [R-08.2012] emphasized that reference to ª®rst,º ªsecond,º and ªthirdº blades in the claim was not used to show a The transitional phrases ªcomprisingº, ªconsisting serial or numerical limitation but instead was used essentially ofº and ªconsisting ofº de®ne the scope to distinguish or identify the various members of the of a claim with respect to what unrecited additional group. Id. components or steps, if any, are excluded from the scope of the claim. The determination of what is or The transitional phrase ªconsisting ofº excludes any is not excluded by a transitional phrase must be made element, step, or ingredient not speci®ed in the on a case-by-case basis in light of the facts of each claim. In re Gray, 53 F.2d 520, 11 USPQ 255 case. (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (ªconsisting ofº de®ned as ªclosing The transitional term ªcomprisingº, which is the claim to the inclusion of materials other than synonymous with ªincluding,º ªcontaining,º or those recited except for impurities ordinarily ªcharacterized by,º is inclusive or open-ended and associated therewithº). But see Norian Corp. v. does not exclude additional, unrecited elements or Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 1508, 1516 (Fed. Cir. 2004) (holding that a bone 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. repair kit ªconsisting ofº claimed chemicals was Cir. 2004) (ª[L]ike the term `comprising,' the terms infringed by a bone repair kit including a spatula in `containing' and `mixture' are open-ended.º). addition to the claimed chemicals because the Invitrogen Corp. v. Biocrest Manufacturing, L.P., presence of the spatula was unrelated to the claimed 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. invention). A claim which depends from a claim Cir. 2003) (ªThe transition `comprising' in a method which ªconsists ofº the recited elements or steps claim indicates that the claim is open-ended and cannot add an element or step. When the phrase allows for additional steps.º); Genentech, Inc. v. ªconsists ofº appears in a clause of the body of a Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, claim, rather than immediately following the 1613 (Fed. Cir. 1997) (ªComprisingº is a term of art preamble, it limits only the element set forth in that used in claim language which means that the named clause; other elements are not excluded from the elements are essential, but other elements may be claim as a whole. Mannesmann Demag added and still form a construct within the scope of Corp. v. Engineered Metal Products Co., 793 F.2d the claim.); Moleculon Research Corp. v. CBS, Inc., 1279, 230 USPQ 45 (Fed. Cir. 1986). See also In 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Crish, 393 F.3d 1253, 73 USPQ2d 1364 (Fed. re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 Cir. 2004) (The claims at issue ªrelated to puri®ed (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 DNA molecules having promoter activity for the (Bd. App. 1948) (ªcomprisingº leaves ªthe claim human involucrin gene (hINV).º Id., 73 USPQ2d open for the inclusion of unspeci®ed ingredients at 1365. In determining the scope of applicant's even in major amountsº). In Gillette Co. v. claims directed to ªa puri®ed oligonucleotide Energizer Holdings Inc., 405 F.3d 1367, 1371-73, comprising at least a portion of the nucleotide 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the sequence of SEQ ID NO:1 wherein said portion court held that a claim to ªa safety razor blade unit consists of the nucleotide sequence from ¼ to 2473 comprising a guard, a cap, and a group of ®rst, of SEQ ID NO:1, and wherein said portion of the second, and third bladesº encompasses razors with nucleotide sequence of SEQ ID NO:1 has promoter more than three blades because the transitional activity,º the court stated that the use of ªconsistsº phrase ªcomprisingº in the preamble and the phrase in the body of the claims did not limit the ªgroup ofº are presumptively open-ended. ªThe word open-ended ªcomprisingº language in the claims `comprising' transitioning from the preamble to the (emphases added). Id. at 1257, 73 USPQ2d at 1367. body signals that the entire claim is presumptively The court held that the claimed promoter sequence

2100-45 Rev. 07.2015, October 2015 § 2111.03 MANUAL OF PATENT EXAMINING PROCEDURE

designated as SEQ ID NO:1 was obtained by claims of what the basic and novel characteristics sequencing the same prior art plasmid and was actually are, ªconsisting essentially ofº will be therefore anticipated by the prior art plasmid which construed as equivalent to ªcomprising.º See, e.g., necessarily possessed the same DNA sequence as PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (ªPPG the claimed oligonucleotides. Id. at 1256 and 1259, could have de®ned the scope of the phrase 73 USPQ2d at 1366 and 1369. The court af®rmed `consisting essentially of' for purposes of its patent the Board's interpretation that the transition phrase by making clear in its speci®cation what it regarded ªconsistsº did not limit the claims to only the recited as constituting a material change in the basic and numbered nucleotide sequences of SEQ ID NO:1 novel characteristics of the invention.º). See also and that ªthe transition language `comprising' AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41, allowed the claims to cover the entire involucrin 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003) gene plus other portions of the plasmid, as long as (Applicant's statement in the speci®cation that the gene contained the speci®c portions of SEQ ID ªsilicon contents in the coating metal should not NO:1 recited by the claim[s].º Id. at 1256, 73 exceed about 0.5% by weightº along with a USPQ2d at 1366.). discussion of the deleterious effects of silicon provided basis to conclude that silicon in excess of The transitional phrase ªconsisting essentially ofº 0.5% by weight would materially alter the basic and limits the scope of a claim to the speci®ed materials novel properties of the invention. Thus, ªconsisting or steps ªand those that do not materially affect the essentially ofº as recited in the preamble was basic and novel characteristic(s)º of the claimed interpreted to permit no more than 0.5% by weight invention. In re Herz, 537 F.2d 549, 551-52, of silicon in the aluminum coating.); In re 190 USPQ 461, 463 (CCPA 1976) (emphasis in Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ original) (Prior art hydraulic ¯uid required a 893, 895-96 (CCPA 1963). If an applicant contends dispersant which appellants argued was excluded that additional steps or materials in the prior art are from claims limited to a functional ¯uid ªconsisting excluded by the recitation of ªconsisting essentially essentially ofº certain components. In ®nding the of,º applicant has the burden of showing that the claims did not exclude the prior art dispersant, the introduction of additional steps or components would court noted that appellants' speci®cation indicated materially change the characteristics of applicant's the claimed composition can contain any well-known invention. In re De Lajarte, 337 F.2d 870, 143 additive such as a dispersant, and there was no USPQ 256 (CCPA 1964). See also Ex parte evidence that the presence of a dispersant would Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. materially affect the basic and novel characteristic & Inter. 1989) (ªAlthough `consisting essentially of the claimed invention. The prior art composition of' is typically used and de®ned in the context of had the same basic and novel characteristic compositions of matter, we ®nd nothing intrinsically (increased oxidation resistance) as well as additional wrong with the use of such language as a modi®er enhanced detergent and dispersant characteristics.). of method steps. . . [rendering] the claim open only ªA `consisting essentially of' claim occupies a for the inclusion of steps which do not materially middle ground between closed claims that are written affect the basic and novel characteristics of the in a `consisting of' format and fully open claims that claimed method. To determine the steps included are drafted in a `comprising' format.º PPG versus excluded the claim must be read in light of Industries v. Guardian Industries, 156 F.3d 1351, the speci®cation. . . . [I]t is an applicant's burden to 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). establish that a step practiced in a prior art method See also Atlas Powder v. E.I. duPont de Nemours is excluded from his claims by `consisting essentially & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. of' language.º). 1984); In re Janakirama-Rao, 317 F.2d 951, 137 USPQ 893 (CCPA 1963); Water Technologies OTHER TRANSITIONAL PHRASES Corp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097 (Fed. Cir. 1988). For the purposes of searching for Transitional phrases such as ªhavingº must be and applying prior art under 35 U.S.C. 102 and 103, interpreted in light of the speci®cation to determine absent a clear indication in the speci®cation or whether open or closed claim language is intended.

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See, e.g., Lampi Corp. v. American Power Products (®nding that a ªwhereinº clause limited a process Inc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453 claim where the clause gave ªmeaning and purpose (Fed. Cir. 2000) (interpreting the term ªhavingº as to the manipulative stepsº). In In re Giannelli, 739 open terminology, allowing the inclusion of other F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. components in addition to those recited); Crystal Cir. 2014), the court found that an "adapted to" Semiconductor Corp. v. TriTech Microelectronics clause limited a machine claim where "the written Int'l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953, description makes clear that ©adapted to,© as used in 1959 (Fed. Cir. 2001) (term ªhavingº in transitional the [patent] application, has a narrower meaning, phrase ªdoes not create a presumption that the body viz., that the claimed machine is designed or of the claim is openº); Regents of the Univ. of Cal. constructed to be used as a rowing machine whereby v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d a pulling force is exerted on the handles." In Hoffer 1398, 1410 (Fed. Cir. 1997) (in the context of a v. Microsoft Corp., 405 F.3d 1326, 1329, 74 cDNA having a sequence coding for human PI, the USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held term ªhavingº still permitted inclusion of other that when a ª`whereby' clause states a condition that moieties). The transitional phrase ªcomposed ofº is material to patentability, it cannot be ignored in has been interpreted in the same manner as either order to change the substance of the invention.º Id. ªconsisting ofº or ªconsisting essentially of,º However, the court noted that a ª`whereby clause depending on the facts of the particular case. See in a method claim is not given weight when it simply AFG Industries, Inc. v. Cardinal IG Company, 239 expresses the intended result of a process step F.3d 1239, 1245, 57 USPQ2d 1776, 1780-81 (Fed. positively recited.'º Id. (quoting Minton v. Nat'l Cir. 2001) (based on speci®cation and other Ass'n of Securities Dealers, Inc., 336 F.3d 1373, evidence, ªcomposed ofº interpreted in same manner 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). as ªconsisting essentially ofº); In re Bertsch, 132 F.2d 1014, 1019-20, 56 USPQ 379, 384 (CCPA 2111.05 Functional and Nonfunctional 1942) (ªComposed ofº interpreted in same manner Descriptive Material [R-07.2015] as ªconsisting ofº; however, the court further remarked that ªthe words `composed of' may under USPTO personnel must consider all claim limitations certain circumstances be given, in patent law, a when determining patentability of an invention over broader meaning than `consisting of.'º). the prior art. In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 403-04 (Fed. Cir. 1983). Since a 2111.04 ªAdapted to,º ªAdapted for,º claim must be read as a whole, USPTO personnel ªWherein,º and ªWherebyº Clauses may not disregard claim limitations comprised of [R-07.2015] printed matter. See Id. at 1384, 217 USPQ at 403; see also Diamond v. Diehr, 450 U.S. 175, 191, 209 Claim scope is not limited by claim language that USPQ 1, 10 (1981). However, USPTO personnel suggests or makes optional but does not require steps need not give patentable weight to printed matter to be performed, or by claim language that does not absent a new and unobvious functional relationship limit a claim to a particular structure. However, between the printed matter and the substrate. See In examples of claim language, although not re Lowry, 32 F.3d 1579, 1583-84, 32 USPQ2d 1031, exhaustive, that may raise a question as to the 1035 (Fed. Cir. 1994); In re Ngai, 367 F.3d 1336, limiting effect of the language in a claim are: 70 USPQ2d 1862 (Fed. Cir. 2004). The rationale behind the printed matter cases, in which, for (A) ªadapted toº or ªadapted forº clauses; example, written instructions are added to a known (B) ªwhereinº clauses; and product, has been extended to method claims in which an instructional limitation is added to a (C) ªwherebyº clauses. method known in the art. Similar to the inquiry for The determination of whether each of these clauses products with printed matter thereon, in such method is a limitation in a claim depends on the speci®c cases the relevant inquiry is whether a new and facts of the case. See, e.g., Grif®n v. Bertina, 283 unobvious functional relationship with the known F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) method exists. See In re Kao, 639 F.3d 1057,

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1072-73, 98 USPQ2d 1799, 1811-12 (Fed. Cir. properly rejected on prior art because there was no 2011); King Pharmaceuticals Inc. v. Eon Labs Inc., new feature of physical structure and no new relation 616 F.3d 1267, 1279, 95 USPQ2d 1833, 1842 (Fed. of printed matter to physical structure. These Cir. 2010). situations may arise where the claim as a whole is directed towards conveying a message or meaning I. DETERMINING WHETHER A FUNCTIONAL to a human reader independent of the supporting RELATIONSHIP EXISTS BETWEEN PRINTED product. For example, a claimed measuring tape MATTER AND ASSOCIATED PRODUCT (OR having electrical wiring information thereon, or a PROCESS) generically claimed substrate having a picture of a golf ball thereupon, would lack a functional A. Evidence Supporting a Functional Relationship relationship as the claims as a whole are directed towards conveying wiring information (unrelated to To be given patentable weight, the printed matter the measuring tape) or an aesthetically pleasing and associated product must be in a functional image (unrelated to the substrate) to the reader. relationship. A functional relationship can be found Additionally, where the printed matter and product where the printed matter performs some function do not depend upon each other, no functional with respect to the product to which it is associated. relationship exists. For example, in a kit containing See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035 a set of chemicals and a printed set of instructions (citing Gulack, 703 F.2d at 1386, 217 USPQ at 404). for using the chemicals, the instructions are not For instance, indicia on a measuring cup perform related to that particular set of chemicals. In re Ngai, the function of indicating volume within that 367 F.3d at 1339, 70 USPQ2d at 1864. measuring cup. See In re Miller, 418 F.2d 1392, 1396, 164 USPQ 46, 49 (CCPA 1969). A functional II. FUNCTIONAL RELATIONSHIP BETWEEN relationship can also be found where the product PRINTED MATTER AND ASSOCIATED PRODUCT performs some function with respect to the printed (OR PROCESS) MUST BE NEW AND UNOBVIOUS matter to which it is associated. For instance, where a hatband places a string of numbers in a certain Once a functional relationship between the product physical relationship to each other such that a and associated printed matter is found, the claimed algorithm is satis®ed due to the physical investigation shifts to the determination of whether structure of the hatband, the hatband performs a the relationship is new and unobvious. For example, function with respect to the string of numbers. See a claim to a color-coded indicia on a container in Gulack, 703 F.2d at 1386-87, 217 USPQ at 405. which the color indicates the expiration date of the container may give rise to a functional relationship. B. Evidence Against a Functional Relationship The claim may, however, be anticipated by prior art that reads on the claimed invention, or by a However, where a product merely serves as a support combination of prior art that teaches the claimed for printed matter, no functional relationship exists. invention. Such a situation would occur for a hatband with images displayed on the hatband but not arranged III. MACHINE-READABLE MEDIA in any particular sequence. See Gulack, 703 F.2d at 1386, 217 USPQ at 404. Another example in When determining the scope of a claim directed to which a product merely serves as a support would a computer-readable medium containing certain occur for a deck of playing cards having images on programming, the examiner should ®rst look to the each card. See In re Bryan, 2009 U.S. App. LEXIS relationship between the programming and the 6667 (Fed. Cir. 2009) (unpublished). See also Ex intended computer system. Where the programming parte Gwinn, 112 USPQ 439, 446-47 (Bd. Pat. App. performs some function with respect to the computer & Int. 1955), in which the invention was directed to with which it is associated, a functional relationship a set of dice by means of which a game may be will be found. For instance, a claim to played. The claims differed from the prior art solely computer-readable medium programmed with by the printed matter in the dice. The claims were attribute data objects that perform the function of

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facilitating retrieval, addition, and removal of I. SOMETHING WHICH IS OLD DOES NOT information in the intended computer system, BECOME PATENTABLE UPON THE DISCOVERY establishes a functional relationship such that the OF A NEW PROPERTY claimed attribute data objects are given patentable weight. See Lowry, 32 F.3d at 1583-84, 32 USPQ2d ª[T]he discovery of a previously unappreciated at 1035. property of a prior art composition, or of a scienti®c explanation for the prior art's functioning, does not However, where the claim as a whole is directed render the old composition patentably new to the conveying a message or meaning to a human reader discoverer.º Atlas Powder Co. v. Ireco Inc., 190 independent of the intended computer system, and/or F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. the computer-readable medium merely serves as a 1999). Thus the claiming of a new use, new function support for information or data, no functional or unknown property which is inherently present in relationship exists. For example, a claim to a the prior art does not necessarily make the claim memory stick containing tables of batting averages, patentable. In re Best, 562 F.2d 1252, 1254, 195 or tracks of recorded music, utilizes the intended USPQ 430, 433 (CCPA 1977). In In re Crish, 393 computer system merely as a support for the F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. information. Such claims are directed toward 2004), the court held that the claimed promoter conveying meaning to the human reader rather than sequence obtained by sequencing a prior art plasmid towards establishing a functional relationship that was not previously sequenced was anticipated between recorded data and the computer. by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed A claim directed to a computer readable medium oligonucleotides . The court stated that ªjust as the storing instructions or executable code that recites discovery of properties of a known material does an abstract idea must be evaluated for eligibility not make it novel, the identi®cation and under 35 U.S.C. 101. See MPEP § 2106. characterization of a prior art material also does not make it novel.º Id. See also MPEP § 2112.01 with regard to inherency and product-by-process claims 2112 Requirements of Rejection Based on and MPEP § 2141.02 with regard to inherency and Inherency; Burden of Proof [R-07.2015] rejections under 35 U.S.C. 103.

[Editor Note: This MPEP section is applicable to II. INHERENT FEATURE NEED NOT BE applications subject to the ®rst inventor to ®le RECOGNIZED AT THE TIME OF THE (FITF) provisions of the AIA except that the relevant INVENTION date is the "effective ®ling date" of the claimed invention instead of the "time of the invention," There is no requirement that a person of which is only applicable to applications subject to ordinary skill in the art would have recognized the pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) inherent disclosure at the time of invention, but only and MPEP § 2150 et seq.] that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. The express, implicit, and inherent disclosures of a Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 prior art reference may be relied upon in the rejection (Fed. Cir. 2003) (rejecting the contention that of claims under 35 U.S.C. 102 or 103. ªThe inherent inherent anticipation requires recognition by a person teaching of a prior art reference, a question of fact, of ordinary skill in the art before the critical date and arises both in the context of anticipation and allowing expert testimony with respect to obviousness.º In re Napier, 55 F.3d 610, 613, 34 post-critical date clinical trials to show inherency); USPQ2d 1782, 1784 (Fed. Cir. 1995) (af®rmed a see also Toro Co. v. Deere & Co., 355 F.3d 1313, 35 U.S.C. 103 rejection based in part on inherent 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) disclosure in one of the references). See also In re (ª[T]he fact that a characteristic is a necessary Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 feature or result of a prior-art embodiment (that is (Fed. Cir. 1983). itself suf®ciently described and enabled) is enough for inherent anticipation, even if that fact was

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unknown at the time of the prior invention.º); Abbott 102.º In re Best, 562 F.2d 1252, 1255 n.4, 195 Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, USPQ 430, 433 n.4 (CCPA 1977). This same 51 USPQ2d 1307, 1310 (Fed.Cir.1999) (ªIf a product rationale should also apply to product, apparatus, that is offered for sale inherently possesses each of and process claims claimed in terms of function, the limitations of the claims, then the invention is property or characteristic. Therefore, a 35 U.S.C. on sale, whether or not the parties to the transaction 102/103 rejection is appropriate for these types of recognize that the product possesses the claimed claims as well as for composition claims. characteristics.º); Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 IV. EXAMINER MUST PROVIDE RATIONALE (Fed. Cir. 1999) (ªBecause `suf®cient aeration' was OR EVIDENCE TENDING TO SHOW INHERENCY inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] The fact that a certain result or characteristic may invention.... An inherent structure, composition, or occur or be present in the prior art is not suf®cient function is not necessarily known.º); SmithKline to establish the inherency of that result or Beecham Corp. v. Apotex Corp., 403 F.3d 1331, characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) 28 USPQ2d 1955, 1957 (Fed. Cir. 1993) (reversed (holding that a prior art patent to an anhydrous form rejection because inherency was based on what of a compound ªinherentlyº anticipated the claimed would result due to optimization of conditions, not hemihydrate form of the compound because what was necessarily present in the prior art); In re practicing the process in the prior art to manufacture Oelrich, 666 F.2d 578, 581-82, 212 USPQ 323, 326 the anhydrous compound ªinherently results in at (CCPA 1981). Also, ª[a]n invitation to investigate least trace amounts ofº the claimed hemihydrate is not an inherent disclosureº where a prior art even if the prior art did not discuss or recognize the reference ªdiscloses no more than a broad genus of hemihydrate); In re Omeprazole Patent Litigation, potential applications of its discoveries.º Metabolite 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d Cir. 2007) (The court noted that although the 1354, 1367, 71 USPQ2d 1081, 1091 (Fed. Cir. 2004) inventors may not have recognized that a (explaining that ª[a] prior art reference that discloses characteristic of the ingredients in the prior art a genus still does not inherently disclose all species method resulted in an in situ formation of a within that broad categoryº but must be examined separating layer, the in situ formation was to see if a disclosure of the claimed species has been nevertheless inherent. ªThe record shows formation made or whether the prior art reference merely of the in situ separating layer in the prior art even invites further experimentation to ®nd the species). though that process was not recognized at the time. The new realization alone does not render that ªIn relying upon the theory of inherency, the necessary [sic] prior art patentable.º) examiner must provide a basis in fact and/or technical reasoning to reasonably support the III. A REJECTION UNDER 35 U.S.C. 102/103 CAN determination that the allegedly inherent BE MADE WHEN THE PRIOR ART PRODUCT characteristic necessarily ¯ows from the teachings SEEMS TO BE IDENTICAL EXCEPT THAT THE of the applied prior art.º Ex parte Levy, 17 USPQ2d PRIOR ART IS SILENT AS TO AN INHERENT 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis CHARACTERISTIC in original) (Applicant's invention was directed to a biaxially oriented, ¯exible dilation catheter balloon Where applicant claims a composition in terms of a (a tube which expands upon in¯ation) used, for function, property or characteristic and the example, in clearing the blood vessels of heart composition of the prior art is the same as that of patients). The examiner applied a U.S. patent to the claim but the function is not explicitly disclosed Schjeldahl which disclosed injection molding a by the reference, the examiner may make a rejection tubular preform and then injecting air into the under both 35 U.S.C. 102 and 103, expressed as a preform to expand it against a mold (blow molding). 102/103 rejection. ªThere is nothing inconsistent in The reference did not directly state that the end concurrent rejections for obviousness under product balloon was biaxially oriented. It did 35 U.S.C. 103 and for anticipation under 35 U.S.C.

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disclose that the balloon was ªformed from a thin INHERENCY, THE BURDEN OF PRODUCTION ¯exible inelastic, high tensile strength, biaxially SHIFTS TO THE APPLICANT oriented synthetic plastic material.º Id. at 1462 (emphasis in original). The examiner argued that ª[T]he PTO can require an applicant to prove that Schjeldahl's balloon was inherently biaxially the prior art products do not necessarily or inherently oriented. The Board reversed on the basis that the possess the characteristics of his [or her] claimed examiner did not provide objective evidence or product. Whether the rejection is based on cogent technical reasoning to support the conclusion `inherency' under 35 U.S.C. 102, on ` prima facie of inherency.). obviousness' under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.º In In In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429 re Best, 562 F.2d 1252, 1255, 195 USPQ 430, (Fed. Cir. 1997), the court af®rmed a ®nding that a 433-34 (CCPA 1977) (footnote and citation omitted). prior patent to a conical spout used primarily to The burden of proof is similar to that required with dispense oil from an oil can inherently performed respect to product-by-process claims. In re the functions recited in applicant's claim to a conical Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 container top for dispensing popped popcorn. The (CCPA 1980) (citing Best, 562 F.2d at 1255. examiner had asserted inherency based on the structural similarity between the patented spout and In Fitzgerald, the claims were directed to a applicant's disclosed top, i.e., both structures had self-locking screw-threaded fastener comprising a the same general shape. The court stated: metallic threaded fastener having patches of crystallizable thermoplastic bonded thereto. The [N]othing in Schreiber's [applicant's] claim claim further speci®ed that the thermoplastic had a suggests that Schreiber's container is ©of a reduced degree of crystallization shrinkage. The different shape' than Harz's [patent]. In fact, [ speci®cation disclosed that the locking fastener was ] an embodiment according to Harz (Fig. 5) and made by heating the metal fastener to melt a the embodiment depicted in ®gure 1 of thermoplastic blank which is pressed against the Schreiber's application have the same general metal. After the thermoplastic adheres to the metal shape. For that reason, the examiner was fastener, the end product is cooled by quenching in justi®ed in concluding that the opening of a water. The examiner made a rejection based on a conically shaped top as disclosed by Harz is U.S. patent to Barnes. Barnes taught a self-locking inherently of a size suf®cient to `allow [ ] fastener in which the patch of thermoplastic was several kernels of popped popcorn to pass made by depositing thermoplastic powder on a through at the same time' and that the taper of metallic fastener which was then heated. The end Harz's conically shaped top is inherently of product was cooled in ambient air, by cooling air or such a shape `as to by itself jam up the popped by contacting the fastener with a water trough. The popcorn before the end of the cone and permit court ®rst noted that the two fasteners were identical the dispensing of only a few kernels at a shake or only slightly different from each other. ªBoth of a package when the top is mounted to the fasteners possess the same utility, employ the same container.' The examiner therefore correctly crystallizable polymer (nylon 11), and have an found that Harz established a prima facie case adherent plastic patch formed by melting and then of anticipation. cooling the polymer.º Id. at 596 n.1, 619 F.2d at 70 n.l. The court then noted that the Board had found that Barnes' cooling rate could reasonably be Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. expected to result in a polymer possessing the claimed crystallization shrinkage rate. Applicants V. ONCE A REFERENCE TEACHING PRODUCT had not rebutted this ®nding with evidence that the APPEARING TO BE SUBSTANTIALLY shrinkage rate was indeed different. They had only IDENTICAL IS MADE THE BASIS OF A argued that the crystallization shrinkage rate was REJECTION, AND THE EXAMINER PRESENTS EVIDENCE OR REASONING TENDING TO SHOW dependent on the cool down rate and that the cool down rate of Barnes was much slower than theirs.

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Because a difference in the cool down rate does not 1655, 1658 (Fed. Cir. 1990). Therefore, the prima necessarily result in a difference in shrinkage, facie case can be rebutted by evidence showing that objective evidence was required to rebut the the prior art products do not necessarily possess the 35 U.S.C. 102/103 prima facie case. characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also In Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d Titanium Metals Corp. v. Banner, 778 F.2d 775, 1429, 1432 (Fed.Cir.1997), the court held that 227 USPQ 773 (Fed. Cir. 1985) (Claims were applicant's declaration failed to overcome a prima directed to a titanium alloy containing 0.2-0.4% Mo facie case of anticipation because the declaration did and 0.6-0.9% Ni having corrosion resistance. A not specify the dimensions of either the dispensing Russian article disclosed a titanium alloy containing top that was tested or the popcorn that was used. 0.25% Mo and 0.75% Ni but was silent as to Applicant's declaration merely asserted that a conical corrosion resistance. The Federal Circuit held that dispensing top built according to a ®gure in the prior the claim was anticipated because the percentages art patent was too small to jam and dispense popcorn of Mo and Ni were squarely within the claimed and thus could not inherently perform the functions ranges. The court went on to say that it was recited in applicant's claims. The court pointed out immaterial what properties the alloys had or who the disclosure of the prior art patent was not limited discovered the properties because the composition to use as an oil can dispenser, but rather was broader is the same and thus must necessarily exhibit the than the precise con®guration shown in the patent's properties.). ®gure. The court also noted that the Board of Patent Appeals and Interferences found as a factual matter See also In re Ludtke, 441 F.2d 660, 169 USPQ 563 that a scaled-up version of the top disclosed in the (CCPA 1971) (Claim 1 was directed to a parachute patent would be capable of performing the functions canopy having concentric circumferential panels recited in applicant's claim. radially separated from each other by radially extending tie lines. The panels were separated ªsuch See MPEP § 2113 for more information on the that the critical velocity of each successively larger analogous burden of proof applied to panel will be less than the critical velocity of the product-by-process claims. previous panel, whereby said parachute will sequentially open and thus gradually decelerate.º 2112.01 Composition, Product, and The court found that the claim was anticipated by Apparatus Claims [R-07.2015] Menget. Menget taught a parachute having three circumferential panels separated by tie lines. The I. PRODUCT AND APPARATUS CLAIMS Ð court upheld the rejection ®nding that applicant had WHEN THE STRUCTURE RECITED IN THE failed to show that Menget did not possess the REFERENCE IS SUBSTANTIALLY IDENTICAL functional characteristics of the claims.); Northam TO THAT OF THE CLAIMS, CLAIMED Warren Corp. v. D. F. New®eld Co., 7 F. Supp . 773, PROPERTIES OR FUNCTIONS ARE PRESUMED 22 USPQ 313 (E.D.N.Y. 1934) (A patent to a pencil TO BE INHERENT for cleaning ®ngernails was held invalid because a pencil of the same structure for writing was found Where the claimed and prior art products are in the prior art.). identical or substantially identical in structure or composition, or are produced by identical or II. COMPOSITION CLAIMS Ð IF THE substantially identical processes, a prima facie case COMPOSITION IS PHYSICALLY THE SAME, IT of either anticipation or obviousness has been MUST HAVE THE SAME PROPERTIES established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ªWhen the PTO ªProducts of identical chemical composition can not shows a sound basis for believing that the products have mutually exclusive properties.º In re Spada, of the applicant and the prior art are the same, the 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. applicant has the burden of showing that they are Cir. 1990). A chemical composition and its not.º In re Spada, 911 F.2d 705, 709, 15 USPQ2d properties are inseparable. Therefore, if the prior art

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teaches the identical chemical structure, the of numbers and had a wild-card label instead of one properties applicant discloses and/or claims are of the letters); In re Bryan, 323 Fed. Appx. 898, 901 necessarily present. Id. (Applicant argued that the (Fed. Cir. 2009) (non-precedential) (printed matter claimed composition was a pressure sensitive on game cards bears no new and unobvious adhesive containing a tacky polymer while the functional relationship to game board). product of the reference was hard and abrasion resistant. ªThe Board correctly found that the virtual The court has extended the rationale in the printed identity of monomers and procedures suf®ced to matter cases, in which, for example, written support a prima facie case of unpatentability of instructions are added to a known product, to method Spada's polymer latexes for lack of novelty.º). claims in which "an instruction limitation" (i.e., a limitation ªinformingº someone about the existence III. PRODUCT CLAIMS ± NONFUNCTIONAL of an inherent property of that method) is added to PRINTED MATTER DOES NOT DISTINGUISH a method known in the art. King Pharmaceuticals, CLAIMED PRODUCT FROM OTHERWISE Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279, 95 IDENTICAL PRIOR ART PRODUCT USPQ2d 1833, 1842 (2010). Similar to the inquiry for products with printed matter thereon, for such Where the only difference between a prior art method cases the relevant inquiry is whether a new product and a claimed product is printed matter that and unobvious functional relationship with the is not functionally related to the product, the content known method exists. In King Pharma, the court of the printed matter will not distinguish the claimed found that the relevant determination is whether the product from the prior art. In re Ngai, 367 F.3d "instruction limitation" has a "new and unobvious 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) functional relationship" with the known method of (Claim at issue was a kit requiring instructions and administering the drug with food. Id.. The court a buffer agent. The Federal Circuit held that the held that the relationship was non-functional because claim was anticipated by a prior art reference that "[i]nforming a patient about the bene®ts of a drug taught a kit that included instructions and a buffer in no way transforms the process of taking the drug agent, even though the content of the instructions with food." Id. That is, the actual method of taking differed, explaining ª[i]f we were to adopt a drug with food is the same regardless of whether [applicant's] position, anyone could continue the patient is informed of the bene®ts. Id. ªIn other patenting a product inde®nitely provided that they words, the `informing' limitation `in no way depends add a new instruction sheet to the product.º). See on the method, and the method does not depend on also In re Gulack, 703 F.2d 1381, 1385-86, 217 the `informing' limitation.'" Id. (citing In re Ngai, USPQ 401, 404 (Fed. Cir. 1983) (ªWhere the printed 367 F.3d 1336, 1339 (Fed. Cir. 2004)); see also In matter is not functionally related to the substrate, re Kao, 639 F.3d 1057, 1072-73, 98 USPQ2d 1799, the printed matter will not distinguish the invention 1811-12 (Fed. Cir. 2011). from the prior art in terms of patentability¼.[T]he critical question is whether there exists any new and 2112.02 Process Claims [R-07.2015] unobvious functional relationship between the printed matter and the substrate.º); In re Miller, 418 I. PROCESS CLAIMS Ð PRIOR ART DEVICE F.2d 1392, 1396 (CCPA 1969) (®nding a new and ANTICIPATES A CLAIMED PROCESS IF THE unobvious relationship between a measuring cup DEVICE CARRIES OUT THE PROCESS DURING and writing showing how to ªhalfº a recipe); In re NORMAL OPERATION Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (matters relating to ornamentation only which have Under the principles of inherency, if a prior art no mechanical function cannot be relied upon to device, in its normal and usual operation, would patentably distinguish the claimed invention from necessarily perform the method claimed, then the the prior art); In re Xiao, 462 Fed. Appx. 947, method claimed will be considered to be anticipated 950-51 (Fed. Cir. 2011) (non-precedential) by the prior art device. When the prior art device is (af®rming an obviousness rejection of claims the same as a device described in the speci®cation directed to a tumbler lock that used letters instead for carrying out the claimed method, it can be

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assumed the device will inherently perform the bacteria for protecting the plant from fungal disease. claimed process. In re King, 801 F.2d 1324, 231 Dart was silent as to nematode inhibition but the USPQ 136 (Fed. Cir. 1986) (The claims were Board concluded that nematode inhibition was an directed to a method of enhancing color effects inherent property of the bacteria. The Board noted produced by ambient light through a process of that applicant had stated in the speci®cation that absorption and re¯ection of the light off a coated Wisconsin 526 possesses an 18% nematode substrate. A prior art reference to Donley disclosed inhibition rating.). a glass substrate coated with silver and metal oxide 200-800 angstroms thick. While Donley disclosed II. PROCESS OF USE CLAIMS Ð NEW AND using the coated substrate to produce architectural UNOBVIOUS USES OF OLD STRUCTURES AND colors, the absorption and re¯ection mechanisms of COMPOSITIONS MAY BE PATENTABLE the claimed process were not disclosed. However, King's speci®cation disclosed using a coated The discovery of a new use for an old structure based substrate of Donley's structure for use in his process. on unknown properties of the structure might be The Federal Circuit upheld the Board's ®nding that patentable to the discoverer as a process of using. ªDonley inherently performs the function disclosed In re Hack, 245 F.2d 246, 248, 114 USPQ 161, in the method claims on appeal when that device is 163 (CCPA 1957). However, when the claim recites used in `normal and usual operation'º and found that using an old composition or structure and the ªuseº a prima facie case of anticipation was made out. is directed to a result or property of that composition Id. at 138, 801 F.2d at 1326. It was up to applicant or structure, then the claim is anticipated. In re May, to prove that Donley©s structure would not perform 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA the claimed method when placed in ambient light.). 1978) (Claims 1 and 6, directed to a method of See also In re Best, 562 F.2d 1252, 1255, 195 USPQ effecting nonaddictive analgesia (pain reduction) in 430, 433 (CCPA 1977) (Applicant claimed a process animals, were found to be anticipated by the applied for preparing a hydrolytically-stable zeolitic prior art which disclosed the same compounds for aluminosilicate which included a step of ªcooling effecting analgesia but which was silent as to the steam zeolite ... at a rate suf®ciently rapid that addiction. The court upheld the rejection and stated the cooled zeolite exhibits a X-ray diffraction pattern that the applicants had merely found a new property ....º All the process limitations were expressly of the compound and such a discovery did not disclosed by a U.S. patent to Hansford except the constitute a new use. The court went on to reverse cooling step. The court stated that any sample of the obviousness rejection of claims 2-5 and 7-10 Hansford's zeolite would necessarily be cooled to which recited a process of using a new compound. facilitate subsequent handling. Therefore, a prima The court relied on evidence showing that the facie case under 35 U.S.C. 102/103 was made. nonaddictive property of the new compound was Applicant had failed to introduce any evidence unexpected.). See also In re Tomlinson, 363 F.2d comparing X-ray diffraction patterns showing a 928, 150 USPQ 623 (CCPA 1966) (The claim was difference in cooling rate between the claimed directed to a process of inhibiting light degradation process and that of Hansford or any data showing of polypropylene by mixing it with one of a genus that the process of Hansford would result in a of compounds, including nickel dithiocarbamate. A product with a different X-ray diffraction. Either reference taught mixing polypropylene with nickel type of evidence would have rebutted the prima dithiocarbamate to lower heat degradation. The court facie case under 35 U.S.C. 102. A further analysis held that the claims read on the obvious process of would be necessary to determine if the process was mixing polypropylene with the nickel unobvious under 35 U.S.C. 103.); Ex parte Novitski, dithiocarbamate and that the preamble of the claim 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The was merely directed to the result of mixing the two Board rejected a claim directed to a method for materials. ªWhile the references do not show a protecting a plant from plant pathogenic nematodes speci®c recognition of that result, its discovery by by inoculating the plant with a nematode inhibiting appellants is tantamount only to ®nding a property strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526

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in the old composition.º 363 F.2d at 934, 150 USPQ The structure implied by the process steps should at 628 (emphasis in original)). be considered when assessing the patentability of product-by-process claims over the prior art, 2113 Product-by-Process Claims [R-08.2012] especially where the product can only be de®ned by the process steps by which the product is made, or I. PRODUCT-BY-PROCESS CLAIMS ARE NOT where the manufacturing process steps would be LIMITED TO THE MANIPULATIONS OF THE expected to impart distinctive structural RECITED STEPS, ONLY THE STRUCTURE characteristics to the ®nal product. See, e.g., In re IMPLIED BY THE STEPS Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding ªinterbonded by interfusionº ª[E]ven though product-by-process claims are to limit structure of the claimed composite and limited by and de®ned by the process, determination noting that terms such as ªwelded,º ªintermixed,º of patentability is based on the product itself. The ªground in place,º ªpress ®tted,º and ªetchedº are patentability of a product does not depend on its capable of construction as structural limitations). method of production. If the product in the product-by-process claim is the same as or obvious II. ONCE A PRODUCT APPEARING TO BE from a product of the prior art, the claim is SUBSTANTIALLY IDENTICAL IS FOUND AND A unpatentable even though the prior product was made 35 U.S.C. 102/103 REJECTION MADE, THE by a different process.º In re Thorpe, 777 F.2d 695, BURDEN SHIFTS TO THE APPLICANT TO SHOW 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations AN UNOBVIOUS DIFFERENCE omitted) (Claim was directed to a novolac color developer. The process of making the developer was ªThe Patent Of®ce bears a lesser burden of proof in allowed. The difference between the inventive making out a case of prima facie obviousness for process and the prior art was the addition of metal product-by-process claims because of their peculiar oxide and carboxylic acid as separate ingredients natureº than when a product is claimed in the instead of adding the more expensive pre-reacted conventional fashion. In re Fessmann, 489 F.2d metal carboxylate. The product-by-process claim 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once was rejected because the end product, in both the the examiner provides a rationale tending to show prior art and the allowed process, ends up containing that the claimed product appears to be the same or metal carboxylate. The fact that the metal similar to that of the prior art, although produced by carboxylate is not directly added, but is instead a different process, the burden shifts to applicant to produced in-situ does not change the end product.). come forward with evidence establishing an Furthermore, ª[b]ecause validity is determined based unobvious difference between the claimed product on the requirements of patentability, a patent is and the prior art product. In re Marosi, 710 F.2d invalid if a product made by the process recited in 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) (The a product-by-process claim is anticipated by or claims were directed to a zeolite manufactured by obvious from prior art products, even if those prior mixing together various inorganic materials in art products are made by different processes.º Amgen solution and heating the resultant gel to form a Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, crystalline metal silicate essentially free of alkali 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. metal. The prior art described a process of making 2009). However, in the context of an infringement a zeolite which, after ion exchange to remove alkali analysis, a product-by-process claim is only infringed metal, appeared to be ªessentially free of alkali by a product made by the process recited in the metal.º The court upheld the rejection because the claim. Id. at 1370 (ªa product in the prior art made applicant had not come forward with any evidence by a different process can anticipate a that the prior art was not ªessentially free of alkali product-by-process claim, but an accused product metalº and therefore a different and unobvious made by a different process cannot infringe a product.). product-by-process claimº). See also Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior art disclosed human

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nerve growth factor (b-NGF) isolated from human means-plus-function limitations see MPEP § 2181 placental tissue. The claim was directed to b-NGF - § 2186. produced through genetic engineering techniques. The factor produced seemed to be substantially the I. INHERENCY AND FUNCTIONAL same whether isolated from tissue or produced LIMITATIONS IN APPARATUS CLAIMS through genetic engineering. While the applicant questioned the purity of the prior art factor, no Features of an apparatus may be recited either concrete evidence of an unobvious difference was structurally or functionally. In re Schreiber, 128 presented. The Board stated that the dispositive issue F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. is whether the claimed factor exhibits any 1997). See also MPEP § 2173.05(g). If an examiner unexpected properties compared with the factor concludes that a functional limitation is an inherent disclosed by the prior art. The Board further stated characteristic of the prior art, then to establish a that the applicant should have made some prima case of anticipation or obviousness, the comparison between the two factors to establish examiner should explain that the prior art structure unexpected properties since the materials appeared inherently possesses the functionally de®ned to be identical or only slightly different.). limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also III. THE USE OF 35 U.S.C. 102/103 REJECTIONS Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 FOR PRODUCT-BY-PROCESS CLAIMS HAS BEEN F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. APPROVED BY THE COURTS Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the ª[T]he lack of physical description in a characteristic relied on. In re Schreiber, 128 F.3d product-by-process claim makes determination of at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 the patentability of the claim more dif®cult, since F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971) in spite of the fact that the claim may recite only (ªwhere the Patent Of®ce has reason to believe that process limitations, it is the patentability of the a functional limitation asserted to be critical for product claimed and not of the recited process steps establishing novelty in the claimed subject matter which must be established. We are therefore of the may, in fact, be an inherent characteristic of the prior opinion that when the prior art discloses a product art, it possesses the authority to require the applicant which reasonably appears to be either identical with to prove that the subject matter shown to be in the or only slightly different than a product claimed in prior art does not possess the characteristic relied a product-by-process claim, a rejection based onº). alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a II. MANNER OF OPERATING THE DEVICE DOES practical matter, the Patent Of®ce is not equipped NOT DIFFERENTIATE APPARATUS CLAIM to manufacture products by the myriad of processes FROM THE PRIOR ART put before it and then obtain prior art products and make physical comparisons therewith.º In re Brown, ª[A]pparatus claims cover what a device is, not 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA what a device does.º Hewlett-Packard 1972). Of®ce personnel should note that reliance on Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, the alternative grounds of 35 U.S.C. 102 or 35 U.S.C. 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis 103 does not eliminate the need to explain both the in original). A claim containing a ªrecitation with anticipation and obviousness aspects of the respect to the manner in which a claimed apparatus rejections. is intended to be employed does not differentiate the claimed apparatus from a prior art apparatusº if the 2114 Apparatus and Article Claims Ð prior art apparatus teaches all the structural Functional Language [R-07.2015] limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The For a discussion of case law which provides preamble of claim 1 recited that the apparatus was guidance in interpreting the functional portion of ªfor mixing ¯owing developer materialº and the

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body of the claim recited ªmeans for mixing ..., said terminals `coupled to receive' ®rst and second input mixing means being stationary and completely variables,º the court held that ªthe claimed circuit submerged in the developer material.º The claim does not require any speci®c input or connection ¼ was rejected over a reference which taught all the [a]s such, `coupled to' and `coupled to receive' are structural limitations of the claim for the intended clearly different ¼ [a]s shown in [the ®gures of the] use of mixing ¯owing developer. However, the patent, input terminals ¼ only need to be `capable mixer was only partially submerged in the developer of receiving' an input variable for the multiplexer material. The Board held that the amount of circuit as claimedº. Therefore, the speci®cation submersion is immaterial to the structure of the supported the claim construction ªthat `coupled to mixer and thus the claim was properly rejected.). receive' means `capable of receiving.'º); Intel Corp. v. U.S. Int©l Trade Comm'n, 946 F.2d 821, 832, 20 III. A PRIOR ART DEVICE CAN PERFORM ALL USPQ2d 1161, 1171 (Fed. Cir. 1991) (The court THE FUNCTIONS OF THE APPARATUS CLAIM held that ªprogrammableº claim language required AND STILL NOT ANTICIPATE THE CLAIM only that the accused product could be programmed to perform the claimed functionality.); In re Even if the prior art device performs all the functions Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, recited in the claim, the prior art cannot anticipate 1432 (Fed. Cir. 1997); In re Best, 562 F.2d 1252, the claim if there is any structural difference. It 1254, 195 USPQ 430, 433 (CCPA 1977); In re should be noted, however, that means-plus-function Ludtke, 441 F.2d 660, 663-64, 169 USPQ 563, limitations are met by structures which are equivalent 566-67 (CCPA 1971); In re Swinehart, 439 F.2d to the corresponding structures recited in the 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971) speci®cation. In re Donaldson, 16 F.3d 1189, 1193, (ª[I]t is elementary that the mere recitation of a 29 USPQ2d 1845, 1848 (Fed. Cir. 1994). See also newly discovered function or property, inherently In re Robertson, 169 F.3d 743, 745, 49 USPQ2d possessed by things in the prior art, does not cause 1949, 1951 (Fed. Cir. 1999) (The claims were drawn a claim drawn to those things to distinguish over the to a disposable diaper having three fastening prior artº). See MPEP § 2112 for more information. elements. The reference disclosed two fastening elements that could perform the same function as Conversely, computer-implemented functional claim the three fastening elements in the claims. The limitations may narrow the functionality of the court construed the claims to require three separate device, by limiting the speci®c structure capable of elements and held that the reference did not disclose performing the recited function. Nazomi a separate third fastening element, either expressly Communications, Inc. v. Nokia Corp., 739 F.3d or inherently.). 1339, 1345, 109 USPQ2d 1258, 1262 (Fed Cir. 2014) (The claims were drawn to a CPU that can IV. DETERMINING WHETHER A perform processing of both register-based and COMPUTER-IMPLEMENTED FUNCTIONAL stack-based instructions. Appellant alleged CLAIM LIMITATION IS PATENTABLE OVER infringement of the claims based on claim THE PRIOR ART UNDER 35 U.S.C. 102 AND 103 construction requiring only hardware capable of performing the claimed functionalities. Contrasted Functional claim language that is not limited to a with the ®nding of Intel Corp. v. U.S. Int©l Trade speci®c structure covers all devices that are capable Comm'n, 846 F.2d 821, 832, 20 USPQ2d 1161, 1171 of performing the recited function. Therefore, if the (Fed. Cir. 1991), the court found that ª[s]ince prior art discloses a device that can inherently hardware cannot meet these limitations in the perform the claimed function, a rejection under 35 absence of enabling software, the claims are properly U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate. construed as claiming an apparatus comprising a See In re Translogic Technology, Inc., 504 F.3d combination of hardware and software capable of 1249, 1258, 84 USPQ2d 1929, 1935-1936 (Fed. Cir. practicing the claim limitations.º). 2007) (The claims were drawn to multiplexer circuit. The patent at issue claimed ªcoupled toº and Computer-implemented functional claim limitations ªcoupled to receiveº between various portions of may also be broad because the term ªcomputerº is the circuitry. In reference to the claim phrase ªinput

2100-57 Rev. 07.2015, October 2015 § 2115 MANUAL OF PATENT EXAMINING PROCEDURE

commonly understood by one of ordinary skill in Inc. v. Thomson Corp., 532 F.3d 1318, 1326-27, 87 the art to describe a variety of devices with varying USPQ2d 1350, 1357 (Fed. Cir. 2008). degrees of complexity and capabilities. In re Paulsen, 30 F.3d 1475, 1479-80, 31 USPQ2d 1671, For more information on the obviousness 1674 (Fed. Cir. 1994). Therefore, a claim containing determination, see MPEP § 2141. the term ªcomputerº should not be construed as limited to a computer having a speci®c set of 2115 Material or Article Worked Upon by characteristics and capabilities, unless the term is Apparatus [R-07.2015] modi®ed by other claim terms or clearly de®ned in the speci®cation to be different from its common MATERIAL OR ARTICLE WORKED UPON DOES meaning. Id. In Paulsen, the claims, directed to a NOT LIMIT APPARATUS CLAIMS portable computer, were rejected as anticipated under 35 U.S.C. 102 by a reference that disclosed a Claim analysis is highly fact-dependent. A claim is calculator, because the term ªcomputerº was given only limited by positively recited elements. Thus, the broadest reasonable interpretation consistent with ª[i]nclusion of the material or article worked upon the speci®cation to include a calculator, and a by a structure being claimed does not impart calculator was considered to be a particular type of patentability to the claims.º In re Otto, 312 F.2d computer by those of ordinary skill in the art. Id. 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). When determining whether a computer-implemented functional claim would have been obvious, In Otto, the claims were directed to a core member examiners should note that broadly claiming an for hair curlers (i.e., a particular device) and a automated means to replace a manual function to method of making the core member (i.e., a particular accomplish the same result does not distinguish over method of making that device) and ªnot to a method the prior art. See Leapfrog Enters., Inc. v. of curling hair wherein th[e] particular device is Fisher-Price, Inc., 485 F.3d 1157, 1161, 82 USPQ2d used.º 312 F.2d at 940. The court held that 1687, 1691 (Fed. Cir. 2007) (ªAccommodating a patentability of the claims cannot be based ªupon a prior art mechanical device that accomplishes [a certain procedure for curling hair using th[e] device desired] goal to modern electronics would have been and involving a number of steps in the process.º The reasonably obvious to one of ordinary skill in court noted that ªthe process is irrelevant as is the designing children's learning devices. Applying recitation involving the hair being wound around modern electronics to older mechanical devices has the coreº in terms of determining patentability of been commonplace in recent years.º); In re Venner, the particular device. Id. Therefore, the inclusion 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958); of the material or article worked upon by a structure see also MPEP § 2144.04. Furthermore, being claimed does not impart patentability to the implementing a known function on a computer has claims. been deemed obvious to one of ordinary skill in the art if the automation of the known function on a In Young, a claim to a machine for making concrete general purpose computer is nothing more than the beams included a limitation to the concrete predictable use of prior art elements according to reinforced members made by the machine as well their established functions. KSR Int'l Co. v. Tele¯ex as the structural elements of the machine itself. The Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 court held that the inclusion of the article formed (2007); see also MPEP § 2143, Exemplary within the body of the claim did not, without more, Rationales D and F. Likewise, it has been found to make the claim patentable. be obvious to adapt an existing process to incorporate Internet and Web browser technologies In In re Casey, 370 F.2d 576, 152 USPQ 235 for communicating and displaying information (CCPA 1967), an apparatus claim recited ª[a] taping because these technologies had become machine comprising a supporting structure, a brush commonplace for those functions. Muniauction, attached to said supporting structure, said brush being formed with projecting bristles which

Rev. 07.2015, October 2015 2100-58 PATENTABILITY § 2116.01

terminate in free ends to collectively de®ne a surface Pharmaceuticals, Inc., 336 F.3d 1322, 1327, 67 to which adhesive tape will detachably adhere, and USPQ2d 1511, 1514 (Fed. Cir. 2003). means for providing relative motion between said brush and said supporting structure while said Interpreting the claimed invention as a whole adhesive tape is adhered to said surface.º An requires consideration of all claim limitations. Thus, obviousness rejection was made over a reference to proper claim construction requires treating language Kienzle which taught a machine for perforating in a process claim which recites the making or using sheets. The court upheld the rejection stating that of a nonobvious product as a material limitation. ªthe references in claim 1 to adhesive tape handling The decision in Ochiai speci®cally dispelled any do not expressly or impliedly require any particular distinction between processes of making a product structure in addition to that of Kienzle.º Id. at and methods of using a product with regard to the 580-81. The perforating device had the structure of effect of any product limitations in either type of the taping device as claimed, the difference was in claim. the use of the device, and ªthe manner or method in which such machine is to be utilized is not germane As noted in Brouwer, 77 F.3d at 425, 37 USPQ2d to the issue of patentability of the machine itself.º at 1666, the inquiry as to whether a claimed Id. at 580. invention would have been obvious is ªhighly fact-speci®c by design.º Accordingly, obviousness Note that this line of cases is limited to claims must be assessed on a case-by-case basis. The directed to machinery which works upon an article following decisions are illustrative of the lack of or material in its intended use. per se rules in applying the test for obviousness under 35 U.S.C. 103 and of the fact-intensive 2116 [Reserved] comparison of claimed processes with the prior art: In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985) (The examiner rejected a claim directed 2116.01 Novel, Unobvious Starting Material to a process in which patentable starting materials or End Product [R-08.2012] were reacted to form patentable end products. The prior art showed the same chemical reaction mechanism applied to other chemicals. The court All the limitations of a claim must be considered held that the process claim was obvious over the when weighing the differences between the claimed prior art.); In re Albertson, 332 F.2d 379, 141 USPQ invention and the prior art in determining the 730 (CCPA 1964) (Process of chemically reducing obviousness of a process or method claim. See one novel, nonobvious material to obtain another MPEP § 2143.03. novel, nonobvious material was claimed. The process was held obvious because the reduction reaction was In re Ochiai, 71 F.3d 1565, 37 USPQ2d 1127 (Fed. old.); In re Kanter, 399 F.2d 249, 158 USPQ 331 Cir. 1995) and In re Brouwer, 77 F.3d 422, (CCPA 1968) (Process of siliconizing a patentable 37 USPQ2d 1663 (Fed. Cir. 1996) addressed the base material to obtain a patentable product was issue of whether an otherwise conventional process claimed. Rejection based on prior art teaching the could be patented if it were limited to making or siliconizing process as applied to a different base using a nonobvious product. In both cases, the material was upheld.); Cf. In re Pleuddemann, 910 Federal Circuit held that the use of per se rules is F.2d 823, 15 USPQ2d 1738 (Fed. Cir. 1990) improper in applying the test for obviousness under (Methods of bonding polymer and ®ller using a 35 U.S.C. 103. Rather, 35 U.S.C. 103 requires a novel silane coupling agent held patentable even highly fact-dependent analysis involving taking the though methods of bonding using other silane claimed subject matter as a whole and comparing it coupling agents were well known because the to the prior art. ªA process yielding a novel and process could not be conducted without the new nonobvious product may nonetheless be obvious; agent); In re Kuehl, 475 F.2d 658, 177 USPQ 250 conversely, a process yielding a well-known product (CCPA 1973) (Process of cracking hydrocarbons may yet be nonobvious.º TorPharm, Inc. v. Ranbaxy using novel zeolite catalyst found to be patentable

2100-59 Rev. 07.2015, October 2015 § 2117 MANUAL OF PATENT EXAMINING PROCEDURE -2120 even though catalytic cracking process was old. ªThe III. EFFICACY IS NOT A REQUIREMENT FOR test under 103 is whether in view of the prior art the PRIOR ART ENABLEMENT invention as a whole would have been obvious at the time it was made, and the prior art here does not A prior art reference provides an enabling disclosure include the zeolite, ZK-22. The obviousness of the and thus anticipates a claimed invention if the process of cracking hydrocarbons with ZK-22 as a reference describes the claimed invention in catalyst must be determined without reference to suf®cient detail to enable a person of ordinary skill knowledge of ZK-22 and its properties.º 475 F.2d in the art to carry out the claimed invention; ªproof at 664-665, 177 USPQ at 255.); and In re Mancy, of ef®cacy is not required for a prior art reference 499 F.2d 1289, 182 USPQ 303 (CCPA 1974) (Claim to be enabling for purposes of anticipation.º Impax to a process for the production of a known antibiotic Labs. Inc. v. Aventis Pharm . Inc., 468 F.3d 1366, by cultivating a novel, unobvious microorganism 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See was found to be patentable.). also MPEP § 2122.

2117 2121.01 Use of Prior Art in Rejections Where -2120 [Reserved] Operability is in Question [R-08.2012]

ªIn determining that quantum of prior art disclosure 2121 Prior Art; General Level of Operability which is necessary to declare an applicant's Required to Make a Prima Facie Case invention `not novel' or `anticipated' within section [R-08.2012] 102, the stated test is whether a reference contains an `enabling disclosure'... .º In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968). The I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING disclosure in an assertedly anticipating reference must provide an enabling disclosure of the desired subject matter; mere naming or description of the When the reference relied on expressly anticipates subject matter is insuf®cient, if it cannot be produced or makes obvious all of the elements of the claimed without undue experimentation. Elan Pharm., Inc. invention, the reference is presumed to be operable. v. Mayo Found. For Med. Educ. & Research, 346 Once such a reference is found, the burden is on F.3d 1051, 1054, 68 USPQ2d 1373, 1376 (Fed. Cir. applicant to provide facts rebutting the presumption 2003) (At issue was whether a prior art reference of operability. In re Sasse, 629 F.2d 675, 207 USPQ enabled one of ordinary skill in the art to produce 107 (CCPA 1980). See also MPEP § 716.07. Elan's claimed transgenic mouse without undue experimentation. Without a disclosure enabling one II. WHAT CONSTITUTES AN ªENABLING DISCLOSUREº DOES NOT DEPEND ON THE skilled in the art to produce a transgenic mouse TYPE OF PRIOR ART THE DISCLOSURE IS without undue experimentation, the reference would CONTAINED IN not be applicable as prior art.). A reference contains an ªenabling disclosureº if the public was in The level of disclosure required within a reference possession of the claimed invention before the date to make it an ªenabling disclosureº is the same no of invention. ªSuch possession is effected if one of matter what type of prior art is at issue. It does not ordinary skill in the art could have combined the matter whether the prior art reference is a U.S. publication's description of the invention with his patent, foreign patent, a printed publication or other. [or her] own knowledge to make the claimed There is no basis in the statute (35 U.S.C. 102 or invention.º In re Donohue, 766 F.2d 531, 226 USPQ 103) for discriminating either in favor of or against 619 (Fed. Cir. 1985). prior art references on the basis of nationality. In re Moreton, 288 F.2d 708, 129 USPQ 227 (CCPA 1961).

Rev. 07.2015, October 2015 2100-60 PATENTABILITY § 2121.02

I. 35 U.S.C. 102 REJECTIONS AND ADDITION OF re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA EVIDENCE SHOWING REFERENCE IS 1968). Note, however, that a reference is presumed OPERABLE operable until applicant provides facts rebutting the presumption of operability. In re Sasse, 629 F.2d It is possible to make a 35 U.S.C. 102 rejection even 675, 207 USPQ 107 (CCPA 1980). Therefore, if the reference does not itself teach one of ordinary applicant must provide evidence showing that a skill how to practice the invention, i.e., how to make process for making was not known at the time of the or use the article disclosed. If the reference teaches invention. See the following subsection for the every claimed element of the article, secondary evidentiary standard to be applied. evidence, such as other patents or publications, can be cited to show public possession of the method of II. A REFERENCE DOES NOT CONTAIN AN making and/or using. In re Donohue, 766 F.2d at ªENABLING DISCLOSUREº IF ATTEMPTS AT 533, 226 USPQ at 621. See MPEP § 2131.01 for MAKING THE COMPOUND OR COMPOSITION more information on 35 U.S.C. 102 rejections using WERE UNSUCCESSFUL BEFORE THE DATE OF secondary references to show that the primary INVENTION reference contains an ªenabling disclosure.º When a prior art reference merely discloses the II. 35 U.S.C. 103 REJECTIONS AND USE OF structure of the claimed compound, evidence INOPERATIVE PRIOR ART showing that attempts to prepare that compound were unsuccessful before the date of invention will ªEven if a reference discloses an inoperative device, be adequate to show inoperability. In re Wiggins, it is prior art for all that it teaches.º Beckman 488 F.2d 538, 179 USPQ 421 (CCPA 1971). Instruments v. LKB Produkter AB, 892 F.2d 1547, However, the fact that an author of a publication did 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). not attempt to make the compound disclosed, without Therefore, ªa non-enabling reference may qualify more, will not overcome a rejection based on that as prior art for the purpose of determining publication. In re Donohue, 766 F.2d 531, 226 obviousness under 35 U.S.C. 103.º Symbol Techs. USPQ 619 (Fed. Cir. 1985) (In this case, the Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 examiner had made a rejection under USPQ2d 1241, 1247 (Fed. Cir. 1991). pre-AIA 35 U.S.C. 102(b) over a publication, which disclosed the claimed compound, in combination 2121.02 Compounds and Compositions Ð with two patents teaching a general process of What Constitutes Enabling Prior Art making the particular class of compounds. The [R-08.2012] applicant submitted an af®davit stating that the authors of the publication had not actually synthesized the compound. The court held that the [Editor Note: This MPEP section is applicable to fact that the publication's author did not synthesize applications subject to the ®rst inventor to ®le the disclosed compound was immaterial to the (FITF) provisions of the AIA except that the relevant question of reference operability. The patents were date is the "effective ®ling date" of the claimed evidence that synthesis methods were well known. invention instead of the "time of the invention" or The court distinguished Wiggins, in which a very "date of invention," which are only applicable to similar rejection was reversed. In Wiggins, attempts applications subject to pre-AIA 35 U.S.C. 102. See to make the compounds using the prior art methods 35 U.S.C. 100 (note) and MPEP § 2150 et seq.] were all unsuccessful.). Compare In re Hoeksema, 399 F.2d 269, 158 USPQ 596 (CCPA 1968) (A claim I. ONE OF ORDINARY SKILL IN THE ART MUST to a compound was rejected over a patent to De BE ABLE TO MAKE OR SYNTHESIZE Boer which disclosed compounds similar in structure to those claimed (obvious homologs) and a process Where a process for making the compound is not of making these compounds. Applicant responded developed until after the date of invention, the mere with an af®davit by an expert named Wiley which naming of a compound in a reference, without more, stated that there was no indication in the De Boer cannot constitute a description of the compound. In patent that the process disclosed in De Boer could

2100-61 Rev. 07.2015, October 2015 § 2121.03 MANUAL OF PATENT EXAMINING PROCEDURE

be used to produce the claimed compound and that plant had been sold in Germany and a foreign Plant he did not believe that the process disclosed in De Breeder's Rights (PBR) application for the same Boer could be adapted to the production of the plant had been published in the Community Plant claimed compound. The court held that the facts Variety Of®ce Of®cial Gazette. The court held that stated in this af®davit were legally suf®cient to when (i) a publication identi®es claimed the plant, overcome the rejection and that applicant need not (ii) a foreign sale occurs that puts one of ordinary show that all known processes are incapable of skill in the art in possession of the plant itself, and producing the claimed compound for this showing (iii) such possession permits asexual reproduction would be practically impossible.). of the plant without undue experimentation to one of ordinary skill in the art, then that combination of 2121.03 Plant Genetics Ð What Constitutes facts and events directly conveys the essential Enabling Prior Art [R-08.2012] knowledge of the invention and constitutes a pre-AIA 35 U.S.C. 102(b) statutory bar. Id. at 1129, THOSE OF ORDINARY SKILL MUST BE ABLE 72 USPQ2d at 1041. Although the court agreed with TO GROW AND CULTIVATE THE PLANT the Board that foreign sales may enable an otherwise non-enabling printed publication, the case was When the claims are drawn to plants, the reference, remanded for additional fact-®nding in order to combined with knowledge in the prior art, must determine if the foreign sales of the plant were enable one of ordinary skill in the art to reproduce known to be accessible to the skilled artisan and if the plant. In re LeGrice, 301 F.2d 929, 133 USPQ the skilled artisan could have reproduced the plant 365 (CCPA 1962) (National Rose Society Annual asexually after obtaining it without undue of England and various other catalogues showed experimentation. Id. at 1131, 72 USPQ2d at 1043. color pictures of the claimed roses and disclosed that applicant had raised the roses. The publications were 2121.04 Apparatus and Articles Ð What published more than 1 year before applicant©s ®ling Constitutes Enabling Prior Art [R-08.2012] date. The court held that the publications did not place the rose in the public domain. Information on PICTURES MAY CONSTITUTE AN ªENABLING the grafting process required to reproduce the rose DISCLOSUREº was not included in the publications and such information was necessary for those of ordinary skill Pictures and drawings may be suf®ciently enabling in the art (plant breeders) to reproduce the rose.). to put the public in the possession of the article Compare Ex parte Thomson, 24 USPQ2d 1618 (Bd. pictured. Therefore, such an enabling picture may Pat. App. & Inter. 1992) (Seeds were commercially be used to reject claims to the article. However, the available more than 1 year prior to applicant's ®ling picture must show all the claimed structural features date. One of ordinary skill in the art could grow the and how they are put together. Jockmus v. Leviton, claimed cotton cultivar from the commercially 28 F.2d 812 (2d Cir. 1928). See also MPEP § 2125 available seeds. Thus, the publications describing for a discussion of drawings as prior art. the cotton cultivar had ªenabled disclosures.º The Board distinguished In re LeGrice by ®nding that 2122 Discussion of Utility in the Prior Art the catalogue picture of the rose of In re LeGrice [R-08.2012] was the only evidence in that case. There was no evidence of commercial availability in enabling form UTILITY NEED NOT BE DISCLOSED IN since the asexually reproduced rose could not be REFERENCE reproduced from seed. Therefore, the public would not have possession of the rose by its picture alone, In order to constitute anticipatory prior art, a but the public would have possession of the cotton reference must identically disclose the claimed cultivar based on the publications and the availability compound, but no utility need be disclosed by the of the seeds.). In In re Elsner, 381 F.3d 1125, 1126, reference. In re Schoenwald, 964 F.2d 1122, 1124, 72 USPQ2d 1038, 1040 (Fed. Cir. 2004), prior to 22 USPQ2d 1671, 1673 (Fed. Cir. 1992) (The the critical date of a plant patent application, the application claimed compounds used in ophthalmic

Rev. 07.2015, October 2015 2100-62 PATENTABILITY § 2123

compositions to treat dry eye syndrome. The See also MPEP § 2131.05 and § 2145, subsection examiner found a printed publication which X.D., which discuss prior art that teaches away from disclosed the claimed compound but did not disclose the claimed invention in the context of anticipation a use for the compound. The court found that the and obviousness, respectively. claim was anticipated since the compound and a process of making it was taught by the reference. II. NONPREFERRED AND ALTERNATIVE The court explained that ªno utility need be disclosed EMBODIMENTS CONSTITUTE PRIOR ART for a reference to be anticipatory of a claim to an old compound.º It is enough that the claimed compound Disclosed examples and preferred embodiments do is taught by the reference.). See also Impax Labs. not constitute a teaching away from a broader Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 8 disclosure or nonpreferred embodiments. In re Susi, USPQ2d 1001, 1013 (Fed. Cir. 2006) (ª[P]roof of 440 F.2d 442, 169 USPQ 423 (CCPA 1971). ªA ef®cacy is not required for a prior art reference to known or obvious composition does not become be enabling for purposes of anticipation.º). patentable simply because it has been described as somewhat inferior to some other product for the 2123 Rejection Over Prior Art's Broad same use.º In re Gurley, 27 F.3d 551, 554, 31 Disclosure Instead of Preferred Embodiments USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention [R-08.2012] was directed to an epoxy impregnated ®ber-reinforced printed circuit material. The applied I. PATENTS ARE RELEVANT AS PRIOR ART prior art reference taught a printed circuit material FOR ALL THEY CONTAIN similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The ªThe use of patents as references is not limited to reference, however, disclosed that epoxy was known what the patentees describe as their own inventions for this use, but that epoxy impregnated circuit or to the problems with which they are concerned. boards have ªrelatively acceptable dimensional They are part of the literature of the art, relevant for stabilityº and ªsome degree of ¯exibility,º but are all they contain.º In re Heck, 699 F.2d 1331, inferior to circuit boards impregnated with 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) polyester-imide resins. The court upheld the rejection (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 concluding that applicant's argument that the USPQ 275, 277 (CCPA 1968)). reference teaches away from using epoxy was insuf®cient to overcome the rejection since ªGurley asserted no discovery beyond what was known in A reference may be relied upon for all that it would the art.º Id. at 554, 31 USPQ2d at 1132.). have reasonably suggested to one having ordinary Furthermore, ª[t]he prior art's mere disclosure of skill the art, including nonpreferred embodiments. more than one alternative does not constitute a Merck & Co. v. Biocraft Laboratories, 874 F.2d teaching away from any of these alternatives because 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 such disclosure does not criticize, discredit, or U.S. 975 (1989). See also Upsher-Smith Labs. v. otherwise discourage the solution claimed¼.º In Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. ªThe fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.º).

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re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, the invention was made. Ex parte Erlich, 22 USPQ 1146 (Fed. Cir. 2004). 1463 (Bd. Pat. App. & Inter. 1992).

2124 Exception to the Rule That the Critical 2124.01 Tax Strategies Deemed Within the Reference Date Must Precede the Filing Date Prior Art [R-08.2012] [R-11.2013] [Editor Note: This MPEP section is applicable to IN SOME CIRCUMSTANCES A FACTUAL applications subject to the ®rst inventor to ®le REFERENCE NEED NOT ANTEDATE THE FILING (FITF) provisions of the AIA except that the relevant DATE date is the "effective ®ling date" of the claimed invention instead of the "time of the invention," In certain circumstances, references cited to show a which is only applicable to applications subject to universal fact need not be available as prior art pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) before applicant's ®ling date. In re Wilson, 311 F.2d and MPEP § 2150 et seq.] 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a I. OVERVIEW material or a scienti®c truism. Some speci®c examples in which later publications showing factual The Leahy-Smith America Invents Act (AIA), Public evidence can be cited include situations where the Law 112-29, sec. 14, 125 Stat. 284 (September 16, facts shown in the reference are evidence ªthat, as 2011) provides that for purposes of evaluating an of an application's ®ling date, undue experimentation invention for novelty and nonobviousness under 35 would have been required, In re Corneil, 347 F.2d U.S.C. 102 and 35 U.S.C. 103, any strategy for 563, 568, 145 USPQ 702, 705 (CCPA 1965), or that reducing, avoiding, or deferring tax liability a parameter absent from the claims was or was not (hereinafter "tax strategy"), whether known or critical, In re Rainer, 305 F.2d 505, 507 n.3, 134 unknown at the time of the invention or application USPQ 343, 345 n.3 (CCPA 1962), or that a statement for patent, shall be deemed insuf®cient to in the speci®cation was inaccurate, In re Marzocchi, differentiate a claimed invention from the prior art. 439 F.2d 220, 223 n.4, 169 USPQ 367, 370 n.4 As a result, applicants will no longer be able to rely (CCPA 1971), or that the invention was inoperative on the novelty or non-obviousness of a tax strategy or lacked utility, In re Langer, 503 F.2d 1380, 1391, embodied in their claims to distinguish them from 183 USPQ 288, 297 (CCPA 1974), or that a claim the prior art. Any tax strategy will be considered was inde®nite, In re Glass, 492 F.2d 1228,1232 n.6, indistinguishable from all other publicly available 181 USPQ 31, 34 n.6 (CCPA 1974), or that information that is relevant to a patent's claim of characteristics of prior art products were known, In originality. This provision aims to keep the ability re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA to interpret the tax law and to implement such 1962).º In re Koller, 613 F.2d 819, 823 n.5, interpretation in the public domain, available to all 204 USPQ 702, 706 n.5 (CCPA 1980) (quoting In taxpayers and their advisors. re Hogan, 559 F.2d 595, 605 n.17, 194 USPQ 527, 537 n.17 (CCPA 1977) (emphasis in original)). The term "tax liability" is de®ned for purposes of However, it is impermissible to use a later factual this provision as referring to any liability for a tax reference to determine whether the application is under any federal, state, or local law, or the law of enabled or described as required under 35 U.S.C. any foreign jurisdiction, including any statute, rule, 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. regulation, or ordinance that levies, imposes, or In re Koller, 613 F.2d 819, 823 n. 5, 204 USPQ assesses such tax liability. 702, 706 n.5 (CCPA 1980). References which do not qualify as prior art because they postdate the There are two exclusions to this provision. The ®rst claimed invention may be relied upon to show the is that the provision does not apply to that part of an level of ordinary skill in the art at or around the time invention that is a method, apparatus, technology, computer program product, or system, that is used solely for preparing a tax or information return or

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other tax ®ling, including one that records, transmits, relating to a tax strategy as being within the prior transfers, or organizes data related to such ®ling. art, and not as a patentable difference between the claim and the prior art. This approach is analogous The second is that the provision does not apply to to the treatment of printed matter limitations in a that part of an invention that is a method, apparatus, claim as discussed at MPEP § 2112.01, subsection technology, computer program product, or system, III. that is used solely for ®nancial management, to the Form paragraph 7.06 may be used to indicate claim extent that it is severable from any tax strategy or limitation(s) interpreted as a tax strategy. See MPEP does not limit the use of any tax strategy by any § 706.02(m). taxpayer or tax advisor. III. EXAMPLES DIRECTED TO This provision took effect on September 16, 2011, COMPUTER-IMPLEMENTED METHODS and applies to any patent application that is pending on, or ®led on or after, September 16, 2011, and to A computer-implemented method that is deemed any patent issued on or after September 16, 2011. novel and non-obvious would not be affected by this Accordingly, this provision will apply in a provision even if used for a tax purpose. For reexamination or other post-grant proceeding only example, a novel and non-obvious to patents issued on or after September 16, 2011. computer-implemented method for manipulating data would not be affected by this provision even if II. EXAMINATION GUIDANCE FOR CLAIMS the method organized data for a future tax ®ling. RELATING TO TAX STRATEGIES However, a prior art computer-implemented method would not become non-obvious by implementing a The following procedure should be followed when novel and non-obvious tax strategy. That is, the examining claims relating to tax strategies. presence of limitations relating to the tax strategy would not cause a claim that is otherwise within the 1. Construe the claim in accordance with MPEP prior art to become novel or non-obvious over the § 2111 et seq. prior art. 2. Analyze the claim for compliance with 35 U.S.C. 101 and 112 in accordance with current Thus, for purposes of applying art to a guidance, which is unaffected by this provision. software-related invention under 35 U.S.C. 102 and 3. Identify any limitations relating to a tax 35 U.S.C. 103, claim limitations that are directed strategy, as de®ned above (note the listed solely to enabling individuals to ®le their income exclusions). tax returns or assisting them with managing their ®nances should be given patentable weight, except a. Inventions that fall within the scope of that claim limitations directed to a tax strategy AIA section 14 include those tax strategies especially should not be given patentable weight. suitable for use with tax-favored structures that must meet certain requirements, such as employee bene®t 2125 Drawings as Prior Art [R-08.2012] plans, tax-exempt organizations, or other entities that must be structured or operated in a particular I. DRAWINGS CAN BE USED AS PRIOR ART manner to obtain certain tax consequences. b. Thus, AIA section 14 applies if the effect Drawings and pictures can anticipate claims if they of an invention is to aid in satisfying the quali®cation clearly show the structure which is claimed. In re requirements for a desired tax-favored entity status, Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). to take advantage of the speci®c tax bene®ts offered However, the picture must show all the claimed in a tax-favored structure, or to allow for tax structural features and how they are put together. reduction, avoidance, or deferral not otherwise Jockmus v. Leviton, 28 F.2d 812 (2d Cir. 1928). The automatically available in such entity or structure. origin of the drawing is immaterial. For instance, 4. Evaluate the claim in view of the prior art drawings in a design patent can anticipate or make under 35 U.S.C. 102 and 103, treating any limitations

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obvious the claimed invention as can drawings in U.S.C. 102(a) or Pre-AIA 35 U.S.C. 102(a), utility patents. When the reference is a utility patent, (b), and (d) [R-11.2013] it does not matter that the feature shown is unintended or unexplained in the speci®cation. The I. THE NAME ªPATENTº ALONE DOES NOT drawings must be evaluated for what they reasonably MAKE A DOCUMENT AVAILABLE AS A PRIOR disclose and suggest to one of ordinary skill in the ART PATENT UNDER 35 U.S.C. 102(a) or Pre-AIA art. In re Aslanian, 590 F.2d 911, 200 USPQ 500 35 U.S.C. 102(a) OR (b) (CCPA 1979). See MPEP § 2121.04 for more information on prior art drawings as ªenabled What a foreign country designates to be a patent may disclosures.º not be a patent for purposes of rejection under 35 U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) and (b); II. PROPORTIONS OF FEATURES IN A DRAWING it is the substance of the rights conferred and the ARE NOT EVIDENCE OF ACTUAL way information within the ªpatentº is controlled PROPORTIONS WHEN DRAWINGS ARE NOT TO that is determinative. In re Ekenstam, 256 F.2d 321, SCALE 118 USPQ 349 (CCPA 1958). See the next subsection for further explanation with respect to When the reference does not disclose that the when a document can be applied in a rejection as a drawings are to scale and is silent as to dimensions, ªpatent.º See MPEP § 2135.01 for a further arguments based on measurement of the drawing discussion of the use of ªpatentsº in pre-AIA 35 features are of little value. See U.S.C. 102(d) rejections. Hockerson-Halberstadt, Inc. v. Avia Group Int'l, 222 F.3d 951, 956, 55 USPQ2d 1487, 1491 (Fed. II. A SECRET PATENT IS NOT AVAILABLE AS Cir. 2000) (The disclosure gave no indication that A REFERENCE UNDER 35 U.S.C. 102(a) or Pre-AIA the drawings were drawn to scale. ª[I]t is well 35 U.S.C. 102(a) or (b) UNTIL IT IS AVAILABLE established that patent drawings do not de®ne the TO THE PUBLIC BUT IT MAY BE AVAILABLE precise proportions of the elements and may not be UNDER Pre-AIA 35 U.S.C. 102(d) AS OF GRANT relied on to show particular sizes if the speci®cation DATE is completely silent on the issue.º). However, the description of the article pictured can be relied on, Secret patents are de®ned as patents which are in combination with the drawings, for what they insuf®ciently accessible to the public to constitute would reasonably teach one of ordinary skill in the ªprinted publications.º Decisions on the issue of art. In re Wright, 569 F.2d 1124, 193 USPQ 332 what is suf®ciently accessible to be a ªprinted (CCPA 1977) (ªWe disagree with the Solicitor's publicationº are located in MPEP § 2128 - MPEP § conclusion, reached by a comparison of the relative 2128.01. dimensions of appellant's and Bauer's drawing ®gures, that Bauer `clearly points to the use of a Even if a patent grants an exclusionary right (is chime length of roughly 1/2 to 1 inch for a whiskey enforceable), it is not available as prior art under 35 barrel.' This ignores the fact that Bauer does not U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) or (b) if disclose that his drawings are to scale. ... However, it is secret or private. In re Carlson, 983 F.2d 1032, we agree with the Solicitor that Bauer's teaching 1037, 25 USPQ2d 1207, 1211 (Fed. Cir. 1992). The that whiskey losses are in¯uenced by the distance document must be at least minimally available to the liquor needs to `traverse the pores of the wood' the public to constitute prior art. The patent is (albeit in reference to the thickness of the suf®ciently available to the public for the purposes barrelhead)º would have suggested the desirability of 35 U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) or of an increased chime length to one of ordinary skill (b) if it is laid open for public inspection or in the art bent on further reducing whiskey losses.º disseminated in printed form. See, e.g., In re 569 F.2d at 1127, 193 USPQ at 335-36.) Carlson, 983 F.2d at 1037, 25 USPQ2d at 1211 (ªWe recognize that Geschmacksmuster on display for 2126 Availability of a Document as a public view in remote cities in a far-away land may ªPatentº for Purposes of Rejection Under 35 create a burden of discovery for one without the time, desire, or resources to journey there in person

Rev. 07.2015, October 2015 2100-66 PATENTABILITY § 2126.02

or by agent to observe that which was registered the Reference Is a ªPatentº but Not a under German law. Such a burden, however, is by ªPublicationº [R-11.2013] law imposed upon the hypothetical person of ordinary skill in the art who is charged with OFTEN UNCLAIMED DETAILS FOUND IN THE knowledge of all contents of the relevant prior art.º). PATENT SPECIFICATION CAN BE RELIED ON The date that the patent is made available to the EVEN IF PATENT IS SECRET public is the date it is available as a 35 U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a) or (b) reference. In re When the patented document is used as a patent and Ekenstam, 256 F.2d 321, 118 USPQ 349 (CCPA not as a publication, the examiner is not restricted 1958). But a period of secrecy after granting the to the information conveyed by the patent claims patent has been held to have no effect in connection but may use any information provided in the with pre-AIA 35 U.S.C. 102(d). These patents are speci®cation which relates to the subject matter of usable in rejections under pre-AIA 35 U.S.C. 102(d) the patented claims when making a rejection under as of the date patent rights are granted. In re 35 U.S.C. 102(a) or pre-AIA 35 U.S.C. 102(a), (b) Kathawala, 9 F.3d 942, 946, 28 USPQ2d 1789, or (d). Ex parte Ovist, 152 USPQ 709, 710 (Bd. 1788-89 (Fed. Cir. 1993). See MPEP § 2135 - MPEP App. 1963) (The claim of an Italian patent was § 2135.01 for more information on pre-AIA generic and thus embraced the species disclosed in 35 U.S.C. 102(d). the examples, the Board added that the entire speci®cation was germane to the claimed invention 2126.01 Date of Availability of a Patent as a and upheld the examiner's pre-AIA 35 U.S.C. 102(b) Reference [R-11.2013] rejection.); In re Kathawala, 9 F.3d 942, 28 USPQ2d 1785 (Fed. Cir. 1993) (The claims at issue DATE FOREIGN PATENT IS EFFECTIVE AS A where rejected under pre-AIA 35 U.S.C. 102(d) by REFERENCE IS USUALLY THE DATE PATENT applicant's own parent applications in Greece and RIGHTS ARE FORMALLY AWARDED TO ITS Spain. The applicant argued that the ªinvention ... APPLICANT patented in Spain was not the same `invention' claimed in the U.S. application because the Spanish The date the patent is available as a reference is patent claimed processes for making [compounds generally the date that the patent becomes for inhibition of cholesterol biosynthesis] and claims enforceable. This date is the date the sovereign 1 and 2 were directed to the compounds themselves.º formally bestows patents rights to the applicant. In Id. at 944, 28 USPQ2d at 1786. The Federal Circuit re Monks, 588 F.2d 308, 200 USPQ 129 (CCPA held that ªwhen an applicant ®les a foreign 1978). There is an exception to this rule when the application fully disclosing his invention and having patent is secret as of the date the rights are awarded. the potential to claim his invention in a number of In re Ekenstam, 256 F.2d 321, 118 USPQ 349 ways, the reference in section 102(d) to `invention (CCPA 1958). ... patented' necessarily includes all disclosed aspects of the invention.º Id. at 945-46, 28 USPQ2d at Note that MPEP § 901.05 summarizes in tabular 1789.). form dates of patenting for many foreign patents. For a list of cases that discuss the date of patenting Note that In re Fuge, 272 F.2d 954, 957, 124 USPQ countries for purposes of pre-AIA 35 U.S.C. 102 in 105, 107 (CCPA 1959), does not con¯ict with the particular, see Chisum, Patents § 3.06[4] n.2. above decisions. This decision simply states ªthat, at the least, the scope of the patent embraces 2126.02 Scope of Reference's Disclosure everything included in the [claim].º (emphasis Which Can Be Used to Reject Claims When added).

The courts have interpreted the phrase ªinvention ... patentedº in pre-AIA 35 U.S.C. 102(a), (b), and (d) the same way and have cited decisions without regard to which of these subsections of pre-AIA 35

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U.S.C. 102 was at issue in the particular case at hand. patent claiming priority under 35 U.S.C. 119 or 35 Therefore, it does not seem to matter to which U.S.C. 120. See MPEP § 2154 for prior art under 35 subsection of pre-AIA 35 U.S.C. 102 the cases are U.S.C. 102(a)(2). directed; the court decisions are interchangeable as to this issue. II. APPLICATIONS WHICH HAVE ISSUED AS PATENTS 2127 Domestic and Foreign Patent Applications as Prior Art [R-07.2015] A. A 35 U.S.C. 102(a)(2) or Pre-AIA 35 U.S.C. 102(e) Rejection Cannot Rely on Matter Which Was Canceled from the Application and Thus Did Not Get Published I. ABANDONED APPLICATIONS, INCLUDING in the Issued Patent PROVISIONAL APPLICATIONS Canceled matter in the application ®le of a U.S. Abandoned Applications Disclosed to the Public Can Be Used as Prior Art patent cannot be relied upon in a rejection under 35 U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 102(e). Ex Parte Stalego, 154 USPQ 52, 53 (Bd. App. 1966). ªAn abandoned patent application may become The canceled matter only becomes available as prior evidence of prior art only when it has been art as of the date the application issues into a patent appropriately disclosed, as, for example, when the since this is the date the application ®le history abandoned patent [application] is reference[d] in the becomes available to the public. In re Lund, 376 disclosure of another patent, in a publication, or by F.2d 982, 153 USPQ 625 (CCPA 1967). However, voluntary disclosure under [former Defensive as discussed below, such matter may be available as Publication rule] 37 CFR 1.139 [Reserved].º Lee prior art under 35 U.S.C. 102(a)(1) or pre-AIA 35 Pharmaceutical v. Kreps, 577 F.2d 610, 613, 198 U.S.C. 102(b). For more information on available USPQ 601, 605 (9th Cir. 1978). An abandoned prior art for use in pre-AIA 35 U.S.C. 102(e) patent application becomes available as prior art rejections see MPEP § 2136.02. For more only as of the date the public gains access to it. See information on available prior art for use in 35 37 CFR 1.14(a)(1)(ii) and (iv). However, the subject U.S.C. 102(a)(2) rejections see MPEP § 2154 et seq. matter of an abandoned application, including both provisional and nonprovisional applications, referred to in a prior art U.S. patent or U.S. patent application B. A 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(b) Rejection Over a Published Application May Rely on publication may be relied on in a 35 U.S.C. 102(a)(2) Information that Was Canceled Prior to Publication or pre-AIA 35 U.S.C. 102(e) rejection based on that patent or patent application publication if the Figures that had been canceled from a Canadian disclosure of the abandoned application is actually patent application before issuance of the patent were included or incorporated by reference in the patent. available as prior art under pre-AIA 35 U.S.C. 102(b) Compare In re Lund, 376 F.2d 982, 991, 153 USPQ as of the date the application became publicly 625, 633 (CCPA 1967) (The court reversed a accessible. The patent at issue and its underlying rejection over a patent which was a application were available for public inspection at continuation-in-part of an abandoned application. the Canadian Patent Of®ce more than one year Applicant's ®ling date preceded the issue date of the before the effective ®ling date of the patents in suit. patent reference. The abandoned application Bruckelmyer v. Ground Heaters, Inc., 445 F.3d contained subject matter which was essential to the 1374, 78 USPQ2d 1684 (Fed. Cir. 2006). rejection but which was not carried over into the continuation-in-part. The court held that the subject matter of the abandoned application was not available to the public as of either the parent's or the child's ®ling dates and thus could not be relied on in the pre-AIA 35 U.S.C. 102(e) rejection.). See also MPEP § 901.02. See MPEP § 2136.02 and MPEP § 2136.03 for the 35 U.S.C. 102(e) date of a U.S.

Rev. 07.2015, October 2015 2100-68 PATENTABILITY § 2128

III. FOREIGN APPLICATIONS OPEN FOR that has not been published has an assignee or PUBLIC INSPECTION (LAID OPEN inventor in common with the application being APPLICATIONS) examined, a rejection will be proper in some circumstances. For instance, when the claims Laid Open Applications May Constitute ªPublishedº between the two applications are not independent or Documents distinct, a provisional double patenting rejection is made. See MPEP § 804. If the copending When the speci®cation is not issued in printed form applications differ by at least one inventor and at but is announced in an of®cial journal and anyone least one of the applications would have been can inspect or obtain copies, it is suf®ciently obvious in view of the other, a provisional rejection accessible to the public to constitute a ªpublicationº over 35 U.S.C. 102(a)(2) or 35 U.S.C. 102(e) or 35 within the meaning of 35 U.S.C. 102(a)(1) or U.S.C. 103 is made when appropriate. See MPEP § pre-AIA 35 U.S.C. 102(a) and (b). See In re Wyer, 706.02(f)(2), § 706.02(k), § 706.02(l)(1), § 655 F.2d 221, 210 USPQ 790 (CCPA 1981). 706.02(l)(3) and § 2154.

Older cases have held that laid open patent See MPEP § 706.02(a), § 804 , § 2136 et seq. and applications are not ªpublishedº and cannot § 2154 for information pertaining to rejections constitute prior art. Ex parte Haller, 103 USPQ 332 relying on U.S. application publications. (Bd. App. 1953). However, whether or not a document is ªpublishedº for the purposes of 35 2128 ªPrinted Publicationsº as Prior Art U.S.C. 102 and 35 U.S.C. 103 depends on how [R-11.2013] accessible the document is to the public. As technology has made reproduction of documents easier, the accessibility of the laid open applications I. A REFERENCE IS A ªPRINTED PUBLICATIONº IF IT IS ACCESSIBLE TO THE PUBLIC has increased. Items provided in easily reproducible form have thus become ªprinted publicationsº as the A reference is proven to be a ªprinted publicationº phrase is used in 35 U.S.C. 102. In re Wyer, 655 ªupon a satisfactory showing that such document F.2d 221, 226, 210 USPQ 790, 794 (CCPA 1981) has been disseminated or otherwise made available (Laid open Australian patent application held to be to the extent that persons interested and ordinarily a ªprinted publicationº even though only the abstract skilled in the subject matter or art, exercising was published because it was laid open for public reasonable diligence, can locate it.º In re Wyer, 655 inspection, micro®lmed, ªdiazo copiesº were F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting distributed to ®ve subof®ces having suitable I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. reproduction equipment and the diazo copies were 738, 743, 148 USPQ 537, 540 (SDNY 1966)) (ªWe available for sale.). The contents of a foreign patent agree that `printed publication' should be approached application should not be relied upon as prior art as a unitary concept. The traditional dichotomy until the date of publication (i.e., the insertion into between `printed' and `publication' is no longer the laid open application) can be con®rmed by an valid. Given the state of technology in document examiner's review of a copy of the document. See duplication, data storage, and data retrieval systems, MPEP § 901.05. the `probability of dissemination' of an item very often has little to do with whether or not it is IV. PENDING U.S. APPLICATIONS `printed' in the sense of that word when it was introduced into the patent statutes in 1836. In any As speci®ed in 37 CFR 1.14(a), all pending U.S. event, interpretation of the words `printed' and applications are preserved in con®dence except for `publication' to mean `probability of dissemination' published applications (see also 35 U.S.C. 122(b)), and `public accessibility' respectively, now seems reissue applications, and applications in which a to render their use in the phrase `printed publication' request to open the complete application to somewhat redundant.º) In re Wyer, 655 F.2d at 226, inspection by the public has been granted by the 210 USPQ at 794. Of®ce (37 CFR 1.11(b)). However, if an application

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See also Carella v. Starlight Archery, 804 F.2d 135, The Of®ce policy requiring recordation of the ®eld 231 USPQ 644 (Fed. Cir. 1986) (Starlight Archery of search and search results (see MPEP § 719.05) argued that Carella's patent claims to an archery weighs in favor of ®nding that Internet and on-line sight were anticipated under pre-AIA 35 U.S.C. database references cited by the examiner are 102(a) by an advertisement in a Wisconsin Bow ªaccessible to persons concerned with the art to Hunter Association (WBHA) magazine and a which the document relates and thus most likely to WBHA mailer prepared prior to Carella's ®ling date. avail themselves of its contents.º Wyer, 655 F.2d However, there was no evidence as to when the at 221, 210 USPQ at 790. Of®ce copies of an mailer was received by any of the addressees. Plus, electronic document must be retained if the same the magazine had not been mailed until 10 days after document may not be available for retrieval in the Carella's ®ling date. The court held that since there future. This is especially important for sources such was no proof that either the advertisement or mailer as the Internet and online databases. was accessible to any member of the public before the ®ling date there could be no rejection under B. Date of Availability pre-AIA 35 U.S.C. 102(a).). Prior art disclosures on the Internet or on an on-line II. ELECTRONIC PUBLICATIONS AS PRIOR ART database are considered to be publicly available as of the date the item was publicly posted. Absent A. Status as a ªPrinted Publicationº evidence of the date that the disclosure was publicly posted, if the publication itself does not include a An electronic publication, including an on-line publication date (or retrieval date), it cannot be relied database or Internet publication, is considered to be upon as prior art under 35 U.S.C. 102(a)(1) and a ªprinted publicationº within the meaning of 35 pre-AIA 35 U.S.C. 102(a) or (b). However, it may U.S.C. 102(a)(1) and pre-AIA 35 U.S.C. 102(a) and be relied upon to provide evidence regarding the (b) provided the publication was accessible to state of the art. Examiners may ask the Scienti®c persons concerned with the art to which the and Technical Information Center to ®nd the earliest document relates. See In re Wyer, 655 F.2d 221, date of publication or posting. See MPEP § 227, 210 USPQ 790, 795 (CCPA 1981) 901.06(a), subsection IV.G. (ªAccordingly, whether information is printed, handwritten, or on micro®lm or a magnetic disc or C. Extent of Teachings Relied Upon tape, etc., the one who wishes to characterize the information, in whatever form it may be, as a An electronic publication, like any publication, may `printed publication' ... should produce suf®cient be relied upon for all that it would have reasonably proof of its dissemination or that it has otherwise suggested to one having ordinary skill in the art. See been available and accessible to persons concerned MPEP § 2121.01 and § 2123. Note, however, that with the art to which the document relates and thus if an electronic document which is the abstract of a most likely to avail themselves of its contents.'º patent or printed publication is relied upon in a (citations omitted).). See also Amazon.com v. rejection under 35 U.S.C. 102 or 35 U.S.C. 103, only Barnesandnoble.com, 73 F. Supp. 2d 1228, the text of the abstract (and not the underlying 53 USPQ2d 1115, 1119 (W.D. Wash. 1999) (Pages document) may be relied upon to support the from a website were relied on by defendants as an rejection. In situations where the electronic version anticipatory reference (to no avail), however status and the published paper version of the same or a of the reference as prior art was not challenged.); In corresponding patent or printed publication differ re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. appreciably, each may need to be cited and relied Cir. 1994) (Database printouts of abstracts which upon as independent references based on what they were not themselves prior art publications were disclose. properly relied as providing evidence that the software products referenced therein were ª®rst installedº or ªreleasedº more than one year prior to applicant's ®ling date.).

Rev. 07.2015, October 2015 2100-70 PATENTABILITY § 2128.01

D. Internet Usage Policy thesis could only be found if the researcher's name was known, but the name bears no relationship to See MPEP § 904.02(c) for the portions of the the subject of the thesis. Notably, a dissenting judge, Internet Usage Policy pertaining to Internet searching in Cronyn, indicated that since the theses were and documenting search strategies. See MPEP shelved in the library, it was enough to make them § 707.05 for the proper citation of electronic suf®ciently accessible to the public. The nature of documents. the index was not determinative. The dissenting judge relied on prior Board decisions III. EXAMINER NEED NOT PROVE ANYONE (Gulliksen v. Halberg, 75 USPQ 252, 257 (Bd. App. ACTUALLY LOOKED AT THE DOCUMENT 1937) and Ex parte Hershberger, 96 USPQ 54, 56 (Bd. App. 1952)), which held that shelving a single One need not prove someone actually looked at a copy in a public library makes the work a ªprinted publication when that publication is accessible to publication.º While these Board decisions have not the public through a library or patent of®ce. See In been expressly overruled, they have been criticized re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA in other decisions. See In re Tenney, 254 F.2d 619, 1981); In re Hall, 781 F.2d 897, 228 USPQ 453 117 USPQ 348 (CCPA 1958) (concurring opinion (Fed. Cir. 1986). by J.Rich) (A document, of which there is but one copy, whether it be handwritten, typewritten or on 2128.01 Level of Public Accessibility micro®lm, may be technically accessible to anyone Required [R-07.2015] who can ®nd it. Such a document is not ªprintedº in the sense that a printing press has been used to I. A THESIS PLACED IN A UNIVERSITY reproduce the document. If only technical LIBRARY MAY BE PRIOR ART IF SUFFICIENTLY accessibility were required ªlogic would require the ACCESSIBLE TO THE PUBLIC inclusion within the term [printed] of all unprinted public documents for they are all `accessible.' While A doctoral thesis indexed and shelved in a library is some tribunals have gone quite far in that direction, suf®ciently accessible to the public to constitute as in the `college thesis cases' I feel they have done prior art as a ªprinted publication.º In re Hall, 781 so unjusti®ably and on the wrong theory. Knowledge F.2d 897, 228 USPQ 453 (Fed. Cir. 1986). Even if is not in the possession of the public where there access to the library is restricted, a reference will has been no dissemination, as distinguished from constitute a ªprinted publicationº as long as a technical accessibility...º The real signi®cance of presumption is raised that the portion of the public the word ªprintedº is grounded in the ª probability concerned with the art would know of the invention. of wide circulation.º). See also Deep Welding, Inc. In re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA v. Sciaky Bros., 417 F.2d 1227, 163 USPQ 144 (7th 1978). Cir. 1969) (calling the holding of Ex parte Hershberger ªextremeº). Compare In re Bayer, 568 In In re Hall, general library cataloging and shelving F.2d 1357, 196 USPQ 670 (CCPA 1978) (A practices showed that a doctoral thesis deposited in reference will constitute a ªprinted publicationº as university library would have been indexed, long as a presumption is raised that the portion of cataloged and shelved and thus available to the the public concerned with the art would know of the public before the critical date. Compare In re invention even if accessibility is restricted to only Cronyn, 890 F.2d 1158, 13 USPQ2d 1070 (Fed. Cir. this part of the public. But accessibility to applicant's 1989) wherein doctoral theses were shelved and thesis was restricted to only three members of a indexed by index cards ®led alphabetically by graduate committee. There can be no presumption student name and kept in a shoe box in the chemistry that those concerned with the art would have known library. The index cards only listed the student name of the invention in this case.). and title of the thesis. In Cronyn, the court held that the students' theses were not accessible to the public. II. ORALLY PRESENTED PAPER CAN The court reasoned that the theses had not been either CONSTITUTE A ªPRINTED PUBLICATIONº IF cataloged or indexed in a meaningful way since

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WRITTEN COPIES ARE AVAILABLE WITHOUT Corporation's library. Access to this library was RESTRICTION restricted to those involved in the AESOP-B project. The court held that public access was insuf®cient to A paper which is orally presented in a forum open make the documents ªprinted publications.º). to all interested persons constitutes a ªprinted publicationº if written copies are disseminated IV. PUBLICLY DISPLAYED DOCUMENTS CAN without restriction. Massachusetts Institute of CONSTITUTE A ªPRINTED PUBLICATIONº EVEN Technology v. AB Fortia, 774 F.2d 1104, 1109, 227 IF THE DURATION OF DISPLAY IS FOR ONLY USPQ 428, 432 (Fed. Cir. 1985) (Paper orally A FEW DAYS AND THE DOCUMENTS ARE NOT presented to between 50 and 500 persons at a DISSEMINATED BY COPIES OR INDEXED IN A scienti®c meeting open to all persons interested in LIBRARY OR DATABASE the subject matter, with written copies distributed without restriction to all who requested, is a printed A publicly displayed document where persons of publication. Six persons requested and obtained ordinary skill in the art could see it and are not copies.). An oral presentation at a scienti®c meeting precluded from copying it can constitute a ªprinted or a demonstration at a trade show may be prior art publication,º even if it is not disseminated by the under 35 U.S.C. 102(a)(1)'s provision: ªotherwise distribution of reproductions or copies and/or available to the public.º See MPEP § 2152.02(e). indexed in a library or database. As stated in In re Klopfenstein, 380 F.3d 1345, 1348, 72 USPQ2d III. INTERNAL DOCUMENTS INTENDED TO BE 1117, 1119 (Fed. Cir. 2004), ªthe key inquiry is CONFIDENTIAL ARE NOT ªPRINTED whether or not a reference has been made `publicly PUBLICATIONSº accessible.'º Prior to the critical date, a fourteen-slide presentation disclosing the invention Documents and items only distributed internally was printed and pasted onto poster boards. The within an organization which are intended to remain printed slide presentation was displayed with no con®dential are not ªprinted publicationsº no matter con®dentiality restrictions for approximately three how many copies are distributed. There must be an cumulative days at two different industry events. Id. existing policy of con®dentiality or agreement to at 1347, 72 USPQ2d at 1118. The court noted that remain con®dential within the organization. Mere ªan entirely oral presentation at a scienti®c intent to remain con®dential is insuf®cient. In re conference that includes neither slides nor copies of George, 2 USPQ2d 1880 (Bd. Pat. App. & Inter. the presentation is without question not a ©printed 1987) (Research reports disseminated in-house to publication© for the purposes of [pre-AIA] 35 U.S.C. only those persons who understood the policy of § 102(b). Furthermore, a presentation that includes con®dentiality regarding such reports are not printed a transient display of slides is likewise not publications even though the policy was not necessarily a `printed publication.'º Id. at 1349 n.4, speci®cally stated in writing.); Garret Corp. v. 72 USPQ2d at 1120 n.4. In resolving whether or not United States, 422 F.2d 874, 878, 164 USPQ 521, a temporarily displayed reference that was neither 524 (Ct. Cl.1970) (ªWhile distribution to government distributed nor indexed was nonetheless made agencies and personnel alone may not constitute suf®ciently publicly accessible to count as a ªprinted publication ... distribution to commercial companies publicationº under pre-AIA 35 U.S.C. 102(b), the without restriction on use clearly does.º); Northern court considered the following factors: ªthe length Telecom Inc. v. Datapoint Corp., 908 F.2d 931, 15 of time the display was exhibited, the expertise of USPQ2d 1321 (Fed. Cir. 1990) (Four reports on the the target audience, the existence (or lack thereof) AESOP-B military computer system which were not of reasonable expectations that the material displayed under security classi®cation were distributed to about would not be copied, and the simplicity or ease with ®fty organizations involved in the AESOP-B project. which the material displayed could have been One document contained the legend ªReproduction copied.º Id. at 1350, 72 USPQ2d at 1120. Upon or further dissemination is not authorized.º The other reviewing the above factors, the court concluded documents were of the class that would contain this that the display ªwas suf®ciently publicly accessible legend. The documents were housed in Mitre to count as a `printed publication.'º Id. at 1352, 72 USPQ2d at 1121. See also Diomed, Inc. v.

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Angiodynamics, 450 F.Supp.2d 130 (D. Mass. In re Schlittler, 234 F.2d 882, 110 USPQ 304 2006)(a video that accompanied oral presentations (CCPA 1956). in Austria, Belgium, France, and Italy was held not a printed publication). 2129 Admissions as Prior Art [R-08.2012]

Note that an oral presentation at a scienti®c meeting I. ADMISSIONS BY APPLICANT CONSTITUTE or a demonstration at a trade show may be prior art PRIOR ART under 35 U.S.C. 102(a)(1)'s provision: ªotherwise available to the public.º See MPEP § 2152.02(e). A statement by an applicant in the speci®cation or made during prosecution identifying the work of 2128.02 Date Publication Is Available as a another as ªprior artº is an admission which can be Reference [R-08.2012] relied upon for both anticipation and obviousness determinations, regardless of whether the admitted I. DATE OF ACCESSIBILITY CAN BE SHOWN prior art would otherwise qualify as prior art under THROUGH EVIDENCE OF ROUTINE BUSINESS the statutory categories of 35 U.S.C. 102. Riverwood PRACTICES Int'l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1354, 66 USPQ2d 1331, 1337 (Fed. Cir. 2003); Constant Evidence showing routine business practices can be v. Advanced Micro-Devices Inc., 848 F.2d 1560, used to establish the date on which a publication 1570, 7 USPQ2d 1057, 1063 (Fed. Cir. 1988). became accessible to the public. Speci®c evidence However, even if labeled as ªprior art,º the work of showing when the speci®c document actually the same inventive entity may not be considered became available is not always necessary. Constant prior art against the claims unless it falls under one v. Advanced Micro-Devices, Inc., 848 F.2d 1560, of the statutory categories. Id.; see also Reading & 7 USPQ2d 1057 (Fed. Cir.), cert. denied, 988 U.S. Bates Construction Co. v. Baker Energy Resources 892 (1988) (Court held that evidence submitted by Corp., 748 F.2d 645, 650, 223 USPQ 1168, 1172 Intel regarding undated speci®cation sheets showing (Fed. Cir. 1984) (ª[W]here the inventor continues how the company usually treated such to improve upon his own work product, his speci®cation sheets was enough to show that the foundational work product should not, without a sheets were accessible by the public before the statutory basis, be treated as prior art solely because critical date.); In re Hall, 781 F.2d 897, 228 USPQ he admits knowledge of his own work. It is common 453 (Fed. Cir. 1986) (Librarian's af®davit sense that an inventor, regardless of an admission, establishing normal time frame and practice for has knowledge of his own work.º). indexing, cataloging and shelving doctoral theses established that the thesis in question would have Consequently, the examiner must determine whether been accessible by the public before the critical the subject matter identi®ed as ªprior artº is date.). applicant's own work, or the work of another. In the absence of another credible explanation, examiners II. A JOURNAL ARTICLE OR OTHER should treat such subject matter as the work of PUBLICATION BECOMES AVAILABLE AS PRIOR another. ART ON DATE OF IT IS RECEIVED BY A MEMBER OF THE PUBLIC II. DISCUSSION OF PRIOR ART IN SPECIFICATION A publication disseminated by mail is not prior art until it is received by at least one member of the Where the speci®cation identi®es work done by public. Thus, a magazine or technical journal is another as ªprior art,º the subject matter so identi®ed effective as of the date when ®rst person receives it, is treated as admitted prior art. In re Nomiya, 509 not the date it was mailed or sent to the publisher. F.2d 566, 571, 184 USPQ 607, 611 (CCPA 1975) (holding applicant's labeling of two ®gures in the application drawings as ªprior artº to be an

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admission that what was pictured was prior art to be, material to patentability as de®ned in § relative to applicant's improvement). 1.56(b).º).

III. JEPSON CLAIMS 2130 [Reserved]

Drafting a claim in Jepson format (i.e., the format described in 37 CFR 1.75(e); see MPEP § 2131 Anticipation Ð Application of 35 U.S.C. 608.01(m)) is taken as an implied admission that the 102 [R-11.2013] subject matter of the preamble is the prior art work of another. In re Fout, 675 F.2d 297, 301, 213 A claimed invention may be rejected under 35 U.S.C. USPQ 532, 534 (CCPA 1982) (holding preamble of 102 when the invention is anticipated (or is ªnot Jepson-type claim to be admitted prior art where novelº) over a disclosure that is available as prior applicant's speci®cation credited another as the art. To anticipate a claim, the disclosure must teach inventor of the subject matter of the preamble). every element of the claim. However, this implication may be overcome where applicant gives another credible reason for drafting the claim in Jepson format. In re Ehrreich, 590 ªA claim is anticipated only if each and every F.2d 902, 909-910, 200 USPQ 504, 510 (CCPA element as set forth in the claim is found, either 1979) (holding preamble not to be admitted prior art expressly or inherently described, in a single prior where applicant explained that the Jepson format art reference.º Verdegaal Bros. v. Union Oil Co. of was used to avoid a double patenting rejection in a California, 814 F.2d 628, 631, 2 USPQ2d 1051, co-pending application and the examiner cited no 1053 (Fed. Cir. 1987). ªWhen a claim covers several art showing the subject matter of the preamble). structures or compositions, either generically or as Moreover, where the preamble of a Jepson claim alternatives, the claim is deemed anticipated if any describes applicant's own work, such may not be of the structures or compositions within the scope used against the claims. Reading & Bates of the claim is known in the prior art.º Brown v. Construction Co. v. Baker Energy Resources Corp., 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 748 F.2d 645, 650, 223 USPQ 1168, 1172 (Fed. Cir. (Fed. Cir. 2001) (claim to a system for setting a 1984); Ehrreich, 590 F.2d at 909-910, 200 USPQ computer clock to an offset time to address the Year at 510. 2000 (Y2K) problem, applicable to records with year date data in ªat least one of two-digit, three-digit, or IV. INFORMATION DISCLOSURE STATEMENT four-digitº representations, was held anticipated by (IDS) a system that offsets year dates in only two-digit formats). See also MPEP § 2131.02. ªThe identical Mere listing of a reference in an information invention must be shown in as complete detail as is disclosure statement is not taken as an admission contained in the ... claim.º Richardson v. Suzuki that the reference is prior art against the claims. Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, Riverwood Int'l Corp. v. R.A. Jones & Co., 324 F.3d 1920 (Fed. Cir. 1989). The elements must be 1346, 1354-55, 66 USPQ2d 1331, 1337-38 (Fed Cir. arranged as required by the claim, but this is not an 2003) (listing of applicant's own prior patent in an ipsissimis verbis test, i.e., identity of terminology IDS does not make it available as prior art absent a is not required. In re Bond, 910 F.2d 831, 15 statutory basis); see also 37 CFR 1.97(h) (ªThe USPQ2d 1566 (Fed. Cir. 1990). Note that, in some ®ling of an information disclosure statement shall circumstances, it is permissible to use multiple not be construed to be an admission that the information cited in the statement is, or is considered

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references in a 35 U.S.C. 102 rejection. See MPEP II. TO EXPLAIN THE MEANING OF A TERM § 2131.01. USED IN THE PRIMARY REFERENCE

2131.01 Multiple Reference 35 U.S.C. 102 Extra References or Other Evidence Can Be Used to Rejections [R-11.2013] Show Meaning of a Term Used in the Primary Reference Extrinsic evidence may be used to explain but not Normally, only one reference should be used in expand the meaning of terms and phrases used in making a rejection under 35 U.S.C. 102. However, the reference relied upon as anticipatory of the a 35 U.S.C. 102 rejection over multiple references claimed subject matter. In re Baxter Travenol Labs., has been held to be proper when the extra references 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) are cited to: (Baxter Travenol Labs. invention was directed to a blood bag system incorporating a bag containing (A) Prove the primary reference contains an DEHP, an additive to the plastic which improved ªenabled disclosure;º the bag's red blood cell storage capability. The (B) Explain the meaning of a term used in the examiner rejected the claims over a technical primary reference; or progress report by Becker which taught the same (C) Show that a characteristic not disclosed in blood bag system but did not expressly disclose the the reference is inherent. presence of DEHP. The report, however, did disclose using commercial blood bags. It also disclosed the See subsections I-III below for more explanation of blood bag system as ªvery similar to [Baxter] each circumstance. Travenol's commercial two bag blood container.º Extrinsic evidence (depositions, declarations and I. TO PROVE REFERENCE CONTAINS AN Baxter Travenol's own admissions) showed that ªENABLED DISCLOSUREº commercial blood bags, at the time Becker's report was written, contained DEHP. Therefore, one of Extra References and Extrinsic Evidence Can Be Used ordinary skill in the art would have known that To Show the Primary Reference Contains an ªEnabled ªcommercial blood bagsº meant bags containing Disclosureº DEHP. The claims were thus held to be anticipated.). When the claimed composition or machine is III. TO SHOW THAT A CHARACTERISTIC NOT disclosed identically by the reference, an additional DISCLOSED IN THE REFERENCE IS INHERENT reference may be relied on to show that the primary reference has an ªenabled disclosure.º In re Samour, Extra Reference or Evidence Can Be Used To Show an 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re Inherent Characteristic of the Thing Taught by the Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. Primary Reference 1985) (Compound claims were rejected under pre-AIA 35 U.S.C. 102(b) over a publication in view ªTo serve as an anticipation when the reference is of two patents. The publication disclosed the claimed silent about the asserted inherent characteristic, such compound structure while the patents taught methods gap in the reference may be ®lled with recourse to of making compounds of that general class. The extrinsic evidence. Such evidence must make clear applicant argued that there was no motivation to that the missing descriptive matter is necessarily combine the references because no utility was present in the thing described in the reference, and previously known for the compound and that the 35 that it would be so recognized by persons of ordinary U.S.C. 102 rejection over multiple references was skill.º Continental Can Co. USA v. Monsanto Co., improper. The court held that the publication taught 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 all the elements of the claim and thus motivation to (Fed. Cir. 1991) (The court went on to explain that combine was not required. The patents were only ªthis modest ¯exibility in the rule that `anticipation' submitted as evidence of what was in the public©s requires that every element of the claims appear in possession before applicant's invention.). a single reference accommodates situations in which the common knowledge of technologists is not

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recorded in the reference; that is, where would anticipate the claims unless applicant was technological facts are known to those in the ®eld entitled to his foreign priority date.). of the invention, albeit not known to judges.º 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as II. A REFERENCE THAT CLEARLY NAMES THE long as there is evidence of record establishing CLAIMED SPECIES ANTICIPATES THE CLAIM inherency, failure of those skilled in the art to NO MATTER HOW MANY OTHER SPECIES ARE contemporaneously recognize an inherent property, NAMED function or ingredient of a prior art reference does not preclude a ®nding of anticipation. Atlas Powder A genus does not always anticipate a claim to a Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 species within the genus. However, when the species USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art is clearly named, the species claim is anticipated no references disclosed blasting compositions matter how many other species are additionally containing water-in-oil emulsions with identical named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. ingredients to those claimed, in overlapping ranges App. & Inter. 1990) (The claimed compound was with the claimed composition. The only element of named in a reference which also disclosed 45 other the claims arguably not present in the prior art compounds. The Board held that the compositions was ªsuf®cient aeration . . . entrapped comprehensiveness of the listing did not negate the to enhance sensitivity to a substantial degree.º The fact that the compound claimed was speci®cally Federal Circuit found that the emulsions described taught. The Board compared the facts to the situation in both references would inevitably and inherently in which the compound was found in the Merck have ªsuf®cient aerationº to sensitize the compound Index, saying that ªthe tenth edition of the Merck in the claimed ranges based on the evidence of record Index lists ten thousand compounds. In our view, (including test data and expert testimony). This each and every one of those compounds is ®nding of inherency was not defeated by the fact `described' as that term is used in [pre-AIA] 35 that one of the references taught away from air U.S.C. 102(a), in that publication.º). Id. at 1718. entrapment or purposeful aeration.). See also In re See also In re Sivaramakrishnan, 673 F.2d 1383, King, 801 F.2d 1324, 1327, 231 USPQ 136, 139 213 USPQ 441 (CCPA 1982) (The claims were (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, directed to polycarbonate containing cadmium 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. laurate as an additive. The court upheld the Board's 1985). See MPEP § 2112 - § 2112.02 for case law ®nding that a reference speci®cally naming cadmium on inherency. Also note that the critical date of laurate as an additive amongst a list of many suitable extrinsic evidence showing a universal fact need not salts in polycarbonate resin anticipated the claims. antedate the ®ling date. See MPEP § 2124. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was 2131.02 Genus-Species Situations [R-11.2013] expected to have the same properties as the other salts listed while, as shown in the application, I. A SPECIES WILL ANTICIPATE A CLAIM TO cadmium laurate had unexpected properties. The A GENUS court held that it did not matter that the salt was not disclosed as being preferred, the reference still ªA generic claim cannot be allowed to an applicant anticipated the claims and because the claim was if the prior art discloses a species falling within the anticipated, the unexpected properties were claimed genus.º The species in that case will immaterial.). anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re III. A GENERIC DISCLOSURE WILL Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES 1989) (Gosteli claimed a genus of 21 speci®c CAN BE ªAT ONCE ENVISAGEDº FROM THE chemical species of bicyclic thia-aza compounds in DISCLOSURE Markush claims. The prior art reference applied against the claims disclosed two of the chemical ª[W]hether a generic disclosure necessarily species. The parties agreed that the prior art species anticipates everything within the genus ¼ depends

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on the factual aspects of the speci®c disclosure and of substituents was low at each site, the ring the particular products at issue.º Sano®-Synthelabo positions were limited, and there was a large v. Apotex, Inc., 550 F.3d 1075, 1083, 89 USPQ2d unchanging structural nucleus, resulted in a ®nding 1370, 1375 (Fed. Cir. 2008). See also Osram that the reference suf®ciently described ªeach of the Sylvania Inc. v. American Induction Tech., 701 F.3d various permutations here involved as fully as if he 698, 706, 105 USPQ2d 1368, 1374 (Fed. Cir. 2012) had drawn each structural formula or had written (ªhow one of ordinary skill in the art would each name.º The claimed compound was 1 of these understand the relative size of a genus or species in 20 compounds. Therefore, the reference ªdescribedº a particular technology is of critical importanceº). the claimed compound and the reference anticipated the claims. For example, when a claimed compound is not speci®cally named in a reference, but instead it is In In re Schauman, 572 F.2d 312, 197 USPQ necessary to select portions of teachings within the 5 (CCPA 1978), claims to a speci®c compound were reference and combine them, e.g., select various anticipated because the prior art taught a generic substituents from a list of alternatives given for formula embracing a limited number of compounds placement at speci®c sites on a generic chemical closely related to each other in structure and the formula to arrive at a speci®c composition, properties possessed by the compound class of the anticipation can only be found if the classes of prior art was that disclosed for the claimed substituents are suf®ciently limited or well compound. The broad generic formula seemed to delineated. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. describe an in®nite number of compounds but claim App. & Inter. 1990). If one of ordinary skill in the 1 was limited to a structure with only one variable art is able to ªat once envisageº the speci®c substituent R. This substituent was limited to low compound within the generic chemical formula, the alkyl radicals. One of ordinary skill in the art would compound is anticipated. One of ordinary skill in at once envisage the subject matter within claim 1 the art must be able to draw the structural formula of the reference.). or write the name of each of the compounds included in the generic formula before any of the compounds Compare In re Meyer, 599 F.2d 1026, 202 USPQ can be ªat once envisaged.º One may look to the 175 (CCPA 1979) (A reference disclosing ªalkaline preferred embodiments to determine which chlorine or bromine solutionº embraces a large compounds can be anticipated. In re Petering, 301 number of species and cannot be said to anticipate F.2d 676, 133 USPQ 275 (CCPA 1962). claims to ªalkali metal hypochlorite.º); Akzo N.V. v. International Trade Comm'n, 808 F.2d 1471, In In re Petering, the prior art disclosed a generic 1 USPQ2d 1241 (Fed. Cir. 1986) (Claims to a chemical formula ªwherein X, Y, Z, P, and R©- process for making aramid ®bers using a 98% represent either hydrogen or alkyl radicals, R a side solution of sulfuric acid were not anticipated by a chain containing an OH group.º The court held that reference which disclosed using sulfuric acid this formula, without more, could not anticipate a solution but which did not disclose using a 98% © concentrated sulfuric acid solution.). See MPEP § claim to 7-methyl-9-[d, l -ribityl]-isoalloxazine 2144.08 for a discussion of obviousness in because the generic formula encompassed a vast genus-species situations. number and perhaps even an in®nite number of compounds. However, the reference also disclosed 2131.03 Anticipation of Ranges [R-11.2013] preferred substituents for X, Y, Z, P, R, and R© as follows: where X, P, and R© are hydrogen, where Y I. A SPECIFIC EXAMPLE IN THE PRIOR ART and Z may be hydrogen or methyl, and where R is WHICH IS WITHIN A CLAIMED RANGE ANTICIPATES THE RANGE one of eight speci®c isoalloxazines. The court determined that this more limited generic class consisted of about 20 compounds. The limited ª[W]hen, as by a recitation of ranges or otherwise, number of compounds covered by the preferred a claim covers several compositions, the claim is formula in combination with the fact that the number `anticipated' if one of them is in the prior art.º

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Titanium Metals Corp. v. Banner, 778 F.2d 775, anticipatory, even though there was a slight overlap 227 USPQ 773 (Fed. Cir. 1985) (citing In between the reference's preferred range (150-350 re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 degrees C) and the claimed range. ª[T]he disclosure (CCPA 1962)) (emphasis in original) (Claims to of a range is no more a disclosure of the end points titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and of the range than it is each of the intermediate 0.2-0.4% molybdenum (Mo) were held anticipated points.º Id. at 1000, 78 USPQ2d at 1424. Patentee by a graph in a Russian article on Ti-Mo-Ni alloys described claimed temperature range as ªcriticalº to because the graph contained an actual data point enable the process to operate effectively, and showed corresponding to a Ti alloy containing 0.25% Mo that one of ordinary skill would have expected the and 0.75% Ni and this composition was within the synthesis process to operate differently outside the claimed range of compositions.). claimed range.

II. PRIOR ART WHICH TEACHES A RANGE If the prior art disclosure does not disclose a claimed OVERLAPPING OR TOUCHING THE CLAIMED range with ªsuf®cient speci®cityº to anticipate a RANGE ANTICIPATES IF THE PRIOR ART claimed invention, any evidence of unexpected RANGE DISCLOSES THE CLAIMED RANGE results within the narrow range may render the WITH ªSUFFICIENT SPECIFICITYº claims unobvious. See MPEP § 716.02 et seq. The question of ªsuf®cient speci®cityº is similar to that When the prior art discloses a range which touches of ªclearly envisagingº a species from a generic or overlaps the claimed range, but no speci®c teaching. See MPEP § 2131.02. examples falling within the claimed range are disclosed, a case by case determination must be A 35 U.S.C. 102/103 combination rejection is made as to anticipation. In order to anticipate the permitted if it is unclear if the reference teaches the claims, the claimed subject matter must be disclosed range with ªsuf®cient speci®city.º The examiner in the reference with ªsuf®cient speci®city to must, in this case, provide reasons for anticipation constitute an anticipation under the statute.º What as well as a reasoned statement regarding constitutes a ªsuf®cient speci®cityº is fact obviousness. Ex parte Lee, 31 USPQ2d 1105 (Bd. dependent. If the claims are directed to a narrow Pat. App. & Inter. 1993) (expanded Board). For a range, and the reference teaches a broader range, discussion of the obviousness of ranges see MPEP other facts of the case, must be considered when § 2144.05. determining whether the narrow range is disclosed with ªsuf®cient speci®cityº to constitute an III. PRIOR ART WHICH TEACHES A VALUE OR anticipation of the claims. Compare ClearValue Inc. RANGE THAT IS VERY CLOSE TO, BUT DOES v. Pearl River Polymers Inc., 668 F.3d 1340, 101 NOT OVERLAP OR TOUCH, THE CLAIMED USPQ2d 1773 (Fed. Cir. 2012) with Ato®na v. RANGE DOES NOT ANTICIPATE THE CLAIMED Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 RANGE USPQ2d 1417, 1423 (Fed. Cir. 2006). ª[A]nticipation under § 102 can be found only when In ClearValue, the claim at issue was directed to a the reference discloses exactly what is claimed and process of clarifying water with alkalinity below 50 that where there are differences between the ppm, whereas the prior art taught that the same reference disclosure and the claim, the rejection must process works for systems with alkalinity of 150 be based on § 103 which takes differences into ppm or less. In holding the claim anticipated, the account.º Titanium Metals Corp. v. Banner, 778 court observed that ªthere is no allegation of F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims criticality or any evidence demonstrating any to titanium (Ti) alloy with 0.8% nickel (Ni) and 0.3% difference across the range.º Id. at 1345, 101 molybdenum (Mo) were not anticipated by, although USPQ2d at 1777. In Ato®na, the court held that a they were held obvious over, a graph in a Russian reference temperature range of 100-500 degrees C article on Ti-Mo-Ni alloys in which the graph did not describe the claimed range of 330-450 degrees C with suf®cient speci®city to be

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contained an actual data point corresponding to a Ti that expressly excluded an ingredient held alloy containing 0.25% Mo and 0.75% Ni.). anticipated by reference composition that optionally included that same ingredient); see also Atlas 2131.04 Secondary Considerations Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, [R-08.2012] 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Claimed composition was anticipated by prior art reference Evidence of secondary considerations, such as that inherently met claim limitation of ªsuf®cient unexpected results or commercial success, is aerationº even though reference taught away from irrelevant to 35 U.S.C. 102 rejections and thus cannot air entrapment or purposeful aeration.). overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). 2132 Pre-AIA 35 U.S.C. 102(a) [R-11.2013]

2131.05 Nonanalogous or Disparaging Prior [Editor Note: This MPEP section is not applicable Art [R-08.2012] to applications subject to examination under the ®rst inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et ªArguments that the alleged anticipatory prior art is seq. to determine whether an application is subject `nonanalogous art' or `teaches away from the to examination under the FITF provisions, and invention' or is not recognized as solving the MPEP § 2150 et seq. for examination of applications problem solved by the claimed invention, [are] not subject to those provisions. See MPEP § 2152 et `germane' to a rejection under section 102.º Twin seq. for a detailed discussion of AIA 35 U.S.C. Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. 102(a) and (b).] Ct. 1986) (quoting In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also State Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty Contracting & Eng' g Corp. v. Condotte America, and loss of right to patent. Inc., 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003) (The question of whether a reference A person shall be entitled to a patent unless - is analogous art is not relevant to whether that reference anticipates. A reference may be directed (a) the invention was known or used by others in this to an entirely different problem than the one country, or patented or described in a printed publication in this addressed by the inventor, or may be from an entirely or a foreign country, before the invention thereof by the applicant for a patent. different ®eld of endeavor than that of the claimed ***** invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation I. ªKNOWN OR USEDº recited in the claims.). A. ªKnown or Usedº Means Publicly Known or Used A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. The ªThe statutory language `known or used by others question whether a reference ªteaches awayº from in this country' [pre-AIA 35 U.S.C. 102(a)], means the invention is inapplicable to an anticipation knowledge or use which is accessible to the public.º analysis. Celeritas Technologies Ltd. v. Rockwell Carella v. Starlight Archery, 804 F.2d 135, 231 International Corp., 150 F.3d 1354, 1361, 47 USPQ 644 (Fed. Cir. 1986). The knowledge or use USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The prior is accessible to the public if there has been no art was held to anticipate the claims even though it deliberate attempt to keep it secret. W. L. Gore & taught away from the claimed invention. ªThe fact Assoc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ that a modem with a single carrier data signal is 303 (Fed. Cir. 1983). shown to be less than optimal does not vitiate the fact that it is disclosed.º). See Upsher-Smith Labs. See MPEP § 2128 - § 2128.02 for case law v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d concerning public accessibility of publications. 1213, 1215 (Fed. Cir. 2005)(claimed composition

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B. Another's Sale of a Product Made by a Secret year [grace] period afforded under § 102(b).º In re Process Can Be a Pre-AIA 35 U.S.C. 102(a) Public Use Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982). if the Process Can Be Determined by Examining the Product IV. ªPATENTED IN THIS OR A FOREIGN COUNTRYº ªThe nonsecret use of a claimed process in the usual course of producing articles for commercial purposes See MPEP § 2126 for information on the use of is a public use.º But a secret use of the process secret patents as prior art. coupled with the sale of the product does not result in a public use of the process unless the public could 2132.01 Publications as Pre-AIA 35 U.S.C. learn the claimed process by examining the product. 102(a) Prior Art [R-11.2013] Therefore, secret use of a process by another, even if the product is commercially sold, cannot result in a rejection under pre-AIA 35 U.S.C. 102(a) if an [Editor Note: This MPEP section is not applicable examination of the product would not reveal the to applications subject to examination under the ®rst process. Id. inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et II. ªIN THIS COUNTRYº seq. to determine whether an application is subject to examination under the FITF provisions, and Only Knowledge or Use in the U.S. Can Be Used in a MPEP § 2150 et seq. for examination of applications Pre-AIA 35 U.S.C. 102(a) Rejection subject to those provisions. See MPEP § 2152 et seq. for a detailed discussion of AIA 35 U.S.C. The knowledge or use relied on in a pre-AIA 35 102(a) and (b).] U.S.C. 102(a) rejection must be knowledge or use ªin this country.º Prior knowledge or use which is I. Pre-AIA 35 U.S.C. 102(a) PRIMA FACIE CASE not present in the United States, even if widespread IS ESTABLISHED IF REFERENCE PUBLICATION IS ªBY OTHERSº in a foreign country, cannot be the basis of a rejection under pre-AIA 35 U.S.C. 102(a). In A prima facie case is made out under pre-AIA 35 re Ekenstam, 256 F.2d 321, 118 USPQ 349 (CCPA U.S.C. 102(a) if, within 1 year of the ®ling date, the 1958). Note that the changes made to pre-AIA 35 invention, or an obvious variant thereof, is described U.S.C. 104 by NAFTA (Public Law 103-182) and in a ªprinted publicationº whose authorship differs Uruguay Round Agreements Act (Public Law in any way from the inventive entity unless it is 103-465) do not modify the meaning of ªin this stated within the publication itself that the countryº as used in pre-AIA 35 U.S.C. 102(a) and publication is describing the applicant's work. In thus ªin this countryº still means in the United States re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA 1982). for purposes of pre-AIA 35 U.S.C. 102(a) rejections. See MPEP § 2128 for case law on what constitutes a ªprinted publication.º Note that when the reference III. ªBY OTHERSº is a U.S. patent published within the year prior to the application ®ling date, a pre-AIA 35 U.S.C. ªOthersº Means Any Combination of Authors or Inventors Different Than the Inventive Entity 102(e) rejection should be made. See MPEP § 2136 - § 2136.05 for case law dealing with pre-AIA 35 U.S.C. 102(e). The term ªothersº in pre-AIA 35 U.S.C. 102(a) refers to any entity which is different from the inventive entity. The entity need only differ by one person to II. APPLICANT CAN REBUT PRIMA FACIE CASE BY SHOWING REFERENCE'S DISCLOSURE WAS be ªby others.º This holds true for all types of DERIVED FROM APPLICANT'S OWN WORK references eligible as prior art under pre-AIA 35 U.S.C. 102(a) including publications as well as Applicant's disclosure of his or her own work within public knowledge and use. Any other interpretation the year before the application ®ling date cannot be of pre-AIA 35 U.S.C. 102(a) ªwould negate the one used against him or her under pre-AIA 35 U.S.C.

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102(a). In re Katz, 687 F.2d 450, 215 USPQ 14 evidence in the case, it would be established, under (CCPA 1982) (discussed below). Therefore, where In re Katz, that Kroger and Rod were the only the applicant is one of the co-authors of a publication inventors. However, in this case, there was evidence cited against his or her application, the publication that Knaster had refused to sign an af®davit may be removed as a reference by the ®ling of disclaiming inventorship and Knaster had introduced af®davits made out by the other authors establishing evidence into the case in the form of a letter to the that the relevant portions of the publication PTO in which he alleged that he was a co-inventor. originated with, or were obtained from, applicant. The Board held that the evidence had not been fully Such af®davits are called disclaiming af®davits. Ex developed enough to overcome the rejection. Note parte Hirschler, 110 USPQ 384 (Bd. App. 1952). that the rejection had been made under pre-AIA 35 The rejection can also be overcome by submission U.S.C. 102(f) but the Board treated the issue the of a speci®c declaration by the applicant establishing same as if it had arisen under pre-AIA 35 U.S.C. that the article is describing applicant's own work. 102(a). See also case law dealing with overcoming In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA pre-AIA 35 U.S.C. 102(e) rejections as presented in 1982). However, if there is evidence that the MPEP § 2136.05. Many of the issues are the same. co-author has refused to disclaim inventorship and believes himself or herself to be an inventor, III. A 37 CFR 1.131 AFFIDAVIT CAN BE USED TO applicant's af®davit will not be enough to establish OVERCOME A Pre-AIA 35 U.S.C. 102(a) that applicant is the sole inventor and the rejection REJECTION will stand. Ex parte Kroger, 219 USPQ 370 (Bd. Pat. App. & Int. 1982) (discussed below). It is also When the reference is not a statutory bar under possible to overcome the rejection by adding the pre-AIA 35 U.S.C. 102(b), (c), or (d), applicant can coauthors as inventors to the application if the overcome the rejection by swearing back of the requirements of 35 U.S.C. 116, third paragraph are reference through the submission of an af®davit met. In re Searles, 422 F.2d 431, 164 USPQ 623 under 37 CFR 1.131. In re Foster, 343 F.2d 980, (CCPA 1970). 145 USPQ 166 (CCPA 1965). If the reference is disclosing applicant's own work as derived from In In re Katz, 687 F.2d 450, 215 USPQ 14 (CCPA him or her, applicant may submit either a 37 CFR 1982), Katz stated in a declaration that the coauthors 1.131 af®davit to antedate the reference or a 37 CFR of the publication, Chiorazzi and Eshhar, ªwere 1.132 af®davit to show derivation of the reference students working under the direction and supervision subject matter from applicant and invention by of the inventor, Dr. David H. Katz.º The court held applicant. In re Facius, 408 F.2d 1396, 161 USPQ that this declaration, in combination with the fact 294 (CCPA 1969). See MPEP § 715 for more that the publication was a research paper, was information on when an af®davit under 37 CFR enough to establish Katz as the sole inventor and 1.131 can be used to overcome a reference and what that the work described in the publication was his evidence is required. own. In research papers, students involved only with assay and testing are normally listed as coauthors 2133 Pre-AIA 35 U.S.C. 102(b) [R-07.2015] but are not considered co-inventors. [Editor Note: This MPEP section is not applicable In Ex parte Kroger, 219 USPQ 370 (Bd. Pat. App. to applications subject to examination under the ®rst & Inter. 1982), Kroger, Knaster and others were inventor to ®le (FITF) provisions of the AIA as set listed as authors on an article on photovoltaic power forth in 35 U.S.C. 100 (note). See MPEP § 2159 et generation. The article was used to reject the claims seq. to determine whether an application is subject of an application listing Kroger and Rod as inventors. to examination under the FITF provisions, and Kroger and Rod submitted af®davits declaring MPEP § 2150 et seq. for examination of applications themselves to be the inventors. The af®davits also subject to those provisions. See MPEP § 2152 et stated that Knaster merely carried out assignments seq. for a detailed discussion of AIA 35 U.S.C. and worked under the supervision and direction of 102(a) and (b).] Kroger. The Board stated that if this were the only

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Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. these. In addition, the prior art need not be identical to the claimed invention but will bar patentability if A person shall be entitled to a patent unless - it is an obvious variant thereof. In re Foster, 343 F.2d 980, 145 USPQ 166 (CCPA 1966). See MPEP ***** § 706.02 regarding the effective U.S. ®ling date of an application. (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of 2133.01 Rejections of Continuation-In-Part application for patent in the United States. (CIP) Applications [R-11.2013] *****

I. THE 1-YEAR GRACE PERIOD IS EXTENDED [Editor Note: This MPEP section is not applicable TO THE NEXT WORKING DAY IF IT WOULD to applications subject to examination under the ®rst OTHERWISE END ON A HOLIDAY OR WEEKEND inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et Publications, patents, public uses and sales must seq. to determine whether an application is subject occur ªmore than one year prior to the date of to examination under the FITF provisions, and application for patent in the United Statesº in order MPEP § 2150 et seq. for examination of applications to bar a patent under pre-AIA 35 U.S.C. 102(b). subject to those provisions. See MPEP § 2152 et However, applicant's own activity will not bar a seq. for a detailed discussion of AIA 35 U.S.C. patent if the 1-year grace period expires on a 102(a) and (b).] Saturday, Sunday, or federal holiday and the application's U.S. ®ling date is the next succeeding When applicant ®les a continuation-in-part whose business day. Ex parte Olah, 131 USPQ 41 (Bd. claims are not supported by the parent application, App. 1960). Despite changes to 37 CFR 1.6(a)(2) the effective ®ling date is the ®ling date of the child and 37 CFR 1.10 which require the PTO to accord CIP. Any prior art disclosing the invention or an a ®ling date to an application as of the date of deposit obvious variant thereof having a critical reference as Priority Express Mail® with the U.S. Postal date more than 1 year prior to the ®ling date of the Service in accordance with 37 CFR 1.10 (e.g., a child will bar the issuance of a patent under pre-AIA Saturday ®ling date), the rule changes do not affect 35 U.S.C. 102(b). Paperless Accounting v. Bay applicant©s concurrent right to defer the ®ling of an Area Rapid Transit System, 804 F.2d 659, 665, 231 application until the next business day when the last USPQ 649, 653 (Fed. Cir. 1986). day for ªtaking any actionº falls on a Saturday, Sunday, or a federal holiday (e.g., the last day of the 2133.02 Rejections Based on Publications 1-year grace period falls on a Saturday). and Patents [R-11.2013]

II. THE 1-YEAR TIME BAR IS MEASURED FROM [Editor Note: This MPEP section is not applicable THE U.S. FILING DATE to applications subject to examination under the ®rst inventor to ®le (FITF) provisions of the AIA as set If one discloses his or her own work more than 1 forth in 35 U.S.C. 100 (note). See MPEP § 2159 et year before the ®ling of the patent application, that seq. to determine whether an application is subject person is barred from obtaining a patent. In re Katz, to examination under the FITF provisions, and 687 F.2d 450, 454, 215 USPQ 14, 17 (CCPA 1982). MPEP § 2150 et seq. for examination of applications The 1-year time bar is measured from the U.S. ®ling subject to those provisions. See MPEP § 2152 et date. Thus, applicant will be barred from obtaining seq. for a detailed discussion of AIA 35 U.S.C. a patent if the public came into possession of the 102(a) and (b).] invention on a date before the 1-year grace period ending with the U.S. ®ling date. It does not matter I. APPLICANT'S OWN WORK WHICH WAS how the public came into possession of the invention. AVAILABLE TO THE PUBLIC BEFORE THE Public possession could occur by a public use, public sale, a publication, a patent or any combination of

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GRACE PERIOD MAY BE USED IN A PRE-AIA 35 together although it is quite clear that either may U.S.C. 102(b) REJECTION apply when the other does not.º Dart Indus. v. E.I. du Pont de Nemours & Co., 489 F.2d 1359, 1365, ªAny invention described in a printed publication 179 USPQ 392, 396 (7th Cir. 1973). There may be more than one year prior to the date of a patent a public use of an invention absent any sales activity. application is prior art under Section 102(b), even Likewise, there may be a nonpublic, e.g., ªsecret,º if the printed publication was authored by the patent sale or offer to sell an invention which nevertheless applicant.º De Graffenried v. United States, constitutes a statutory bar. Hobbs v. United States, 16 USPQ2d 1321, 1330 n.7 (Cl. Ct. 1990). ªOnce 451 F.2d 849, 859-60, 171 USPQ 713, 720 (5th Cir. an inventor has decided to lift the veil of secrecy 1971). from his [or her] work, he [or she] must choose between the protection of a federal patent, or the In similar fashion, not all ªpublic useº and ªon saleº dedication of his [or her] idea to the public at large.º activities will necessarily occasion the identical Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 result. Although both activities affect how an U.S. 141, 148, 9 USPQ2d 1847, 1851 (1989). inventor may use an invention prior to the ®ling of a patent application, ªnon-commercialº pre-AIA 35 II. A PRE-AIA 35 U.S.C. 102(b) REJECTION U.S.C. 102(b) activity may not be viewed the same CREATES A STATUTORY BAR TO as similar ªcommercialº activity. See MPEP PATENTABILITY OF THE REJECTED CLAIMS § 2133.03(a) and § 2133.03(e)(1). Likewise, ªpublic useº activity by an applicant may not be considered A rejection under pre-AIA 35 U.S.C. 102(b) cannot in the same light as similar ªpublic useº activity by be overcome by af®davits and declarations under one other than an applicant. See MPEP § 2133.03(a) 37 CFR 1.131 (Rule 131 Declarations), foreign and § 2133.03(e)(7). Additionally, the concept of priority dates, or evidence that applicant himself ªexperimental useº may have different signi®cance invented the subject matter. Outside the 1-year grace in ªcommercialº and ªnon-commercialº period, applicant is barred from obtaining a patent environments. See MPEP § 2133.03(c) and containing any anticipated or obvious claims. In re § 2133.03(e) - § 2133.03(e)(6). Foster, 343 F.2d 980, 984, 145 USPQ 166, 170 (CCPA 1965). It should be noted that pre-AIA 35 U.S.C. 102(b) may create a bar to patentability either alone, if the 2133.03 Rejections Based on ªPublic Useº device in public use or placed on sale anticipates a or ªOn Saleº [R-11.2013] later claimed invention, or in conjunction with 35 U.S.C. 103, if the claimed invention would have [Editor Note: This MPEP section has limited been obvious from the device in conjunction with applicability to applications subject to examination the prior art. LaBounty Mfg. v. United States Int'l under the ®rst inventor to ®le (FITF) provisions of Trade Comm'n, 958 F.2d 1066, 1071, 22 USPQ2d the AIA as set forth in 35 U.S.C. 100 (note). See 1025, 1028 (Fed. Cir. 1992). MPEP § 2159 et seq. to determine whether an application is subject to examination under the FITF I. POLICY CONSIDERATIONS provisions, and MPEP § 2150 et seq. for examination of applications subject to those (A) ªOne policy underlying the [on-sale] bar is provisions. See MPEP § 2152.02(c) through (e) for to obtain widespread disclosure of new inventions a detailed discussion of the public use and on sale to the public via patents as soon as possible.º RCA provisions of AIA 35 U.S.C. 102.] Corp. v. Data Gen. Corp., 887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed. Cir. 1989). Pre-AIA 35 U.S.C. 102(b) ªcontains several distinct (B) Another policy underlying the public use bars to patentability, each of which relates to activity and on-sale bars is to prevent the inventor from or disclosure more than one year prior to the date of commercially exploiting the exclusivity of his [or the application. Two of these - the `public use' and her] invention substantially beyond the statutorily the `on sale' objections - are sometimes considered authorized period. RCA Corp. v. Data Gen. Corp.,

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887 F.2d 1056, 1062, 12 USPQ2d 1449, 1454 (Fed. test, another necessary requirement of a public Cir. 1989). See MPEP § 2133.03(e)(1). use bar (C) Another underlying policy for the public use and on-sale bars is to discourage ªthe removal of Id. at 1380, 76 USPQ2d at 1744 (citations omitted). inventions from the public domain which the public See MPEP § 2133.03(c) for a discussion of the justi®ably comes to believe are freely available.º ªready for patentingº prong of the public use and on Manville Sales Corp. v. Paramount Sys., Inc., sale statutory bars. 917 F.2d 544, 549, 16 USPQ2d 1587, 1591 (Fed. Cir. 1990). ª[T]o constitute the public use of an invention it is 2133.03(a) ªPublic Useº [R-11.2013] not necessary that more than one of the patent articles should be publicly used. The use of a great [Editor Note: This MPEP section is not applicable number may tend to strengthen the proof, but one to applications subject to examination under the ®rst well de®ned case of such use is just as effectual to inventor to ®le (FITF) provisions of the AIA as set annul the patent as many.º Likewise, it is not forth in 35 U.S.C. 100 (note) . See MPEP § 2159 et necessary that more than one person use the seq. to determine whether an application is subject invention. Egbert v. Lippmann, 104 U.S. 333, 336 to examination under the FITF provisions, and (1881). MPEP § 2150 et seq. for examination of applications subject to those provisions. See MPEP § 2152.02(c) II. PUBLIC KNOWLEDGE IS NOT NECESSARILY through (e) for a detailed discussion of the public PUBLIC USE UNDER Pre-AIA 35 U.S.C. 102(b) use and on sale provisions of AIA 35 U.S.C. 102.] Mere knowledge of the invention by the public does I. TEST FOR ªPUBLIC USE not warrant rejection under pre-AIA 35 U.S.C. 102(b). Pre-AIA 35 U.S.C. 102(b) bars public use or sale, not public knowledge. TP Labs., Inc. v. The public use bar under pre-AIA 35 U.S.C. 102(b) Professional Positioners, Inc., 724 F.2d 965, 970, arises where the invention is in public use before the 220 USPQ 577, 581 (Fed. Cir. 1984). critical date and is ready for patenting. Invitrogen Corp. v. Biocrest Manufacturing L.P., 424 F.3d 1374, 76 USPQ2d 1741 (Fed. Cir. 2005). As Note, however, that public knowledge may provide explained by the court, grounds for rejection under pre-AIA 35 U.S.C. 102(a). See MPEP § 2132.

The proper test for the public use prong of the A. Commercial Versus Noncommercial Use and the pre-AIA § 102(b) statutory bar is whether the Impact of Secrecy purported use: (1) was accessible to the public; or (2) was commercially exploited. Commercial There are limited circumstances in which a secret exploitation is a clear indication of public use, or con®dential use of an invention may give rise to but it likely requires more than, for example, a the public use bar. ª[S]ecrecy of use alone is not secret offer for sale. Thus, the test for the public suf®cient to show that existing knowledge has not use prong includes the consideration of been withdrawn from public use; commercial evidence relevant to experimentation, as well exploitation is also forbidden.º Invitrogen, 424 F.3d as, inter alia , the nature of the activity that at 1382, 76 USPQ2d at 1745-46 (The fact that occurred in public; public access to the use; patentee secretly used the claimed invention con®dentiality obligations imposed on members internally before the critical date to develop future of the public who observed the use; and products that were never sold was by itself commercial exploitation¼. That evidence is insuf®cient to create a public use bar to relevant to discern whether the use was a public patentability.). use that could raise a bar to patentability, but it is distinct from evidence relevant to the ready for patenting component of Pfaff 's two-part

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1. ªPublic Useº and ªNon-secret Useº Are Not Expectation of Privacy and the Use Was for His or Necessarily Synonymous Her Own Enjoyment

ªPublicº is not necessarily synonymous with ªnon- An inventor's private use of the invention, for his secret.º The fact ªthat non-secret uses of the device or her own enjoyment is not a public use. Moleculon were made [by the inventor or someone connected Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265, with the inventor] prior to the critical date is not 229 USPQ 805, 809 (Fed. Cir. 1986) (Inventor itself dispositive of the issue of whether activity showed inventive puzzle to close friends while in barring a patent under pre-AIA 35 U.S.C. 102(b) his dorm room and later the president of the company occurred. The fact that the device was not hidden at which he was working saw the puzzle on the from view may make the use not secret, but inventor's desk and they discussed it. Court held that nonsecret use is not ipso facto `public use' activity. the inventor retained control and thus these actions Nor, it must be added, is all secret use ipso facto did not result in a ªpublic use.º). not `public use' within the meaning of the statute,º if the inventor is making commercial use of the 4. The Presence or Absence of a Con®dentiality invention under circumstances which preserve its Agreement is Not Dispositive of the Public Use Issue secrecy. TP Labs., Inc. v. Professional Positioners, Inc., 724 F.2d 965, 972, 220 USPQ 577, 583 (Fed. ªThe presence or absence of a con®dentiality Cir. 1983) (citations omitted). agreement is not dispositive of the public use issue, but `is one factor to be considered in assessing all 2. Even If the Invention Is Hidden, Inventor Who the evidence.'º Bernhardt, L.L.C. v. Collezione Puts Machine or Article Embodying the Invention in Europa USA, Inc., 386 F.3d 1371, 1380-81, 72 Public View Is Barred from Obtaining a Patent as the USPQ2d, 1901, 1909 (Fed. Cir. 2004) (quoting Invention Is in Public Use Moleculon Research Corp. v. CBS Inc., 793 F.2d 1261, 1266, 229 USPQ 805, 808 (Fed. Cir. 1986)). When the inventor or someone connected to the The court stressed that it is necessary to analyze the inventor puts the invention on display or sells it, evidence of public use in the context of policies that there is a ªpublic useº within the meaning of underlie the public use and on sale bar that include pre-AIA 35 U.S.C. 102(b) even though by its very ª`discouraging removal of inventions from the public nature an invention is completely hidden from view domain that the public justi®ably believes are freely as part of a larger machine or article, if the invention available, prohibiting an extension of the period for is otherwise used in its natural and intended way and exploiting an invention, and favoring prompt and the larger machine or article is accessible to the widespread disclosure of inventions.'º Bernhardt, public. In re Blaisdell, 242 F.2d 779, 783, 113 386 F.3d at 1381, 72 USPQ2d at 1909. See also USPQ 289, 292 (CCPA 1957); Hall v. Macneale, Invitrogen, 424 F.3d at 1379, 76 USPQ2d at 1744; 107 U.S. 90, 96-97 (1882); Ex parte Kuklo, 25 MPEP § 2133.03, subsection I. Evidence that the USPQ2d 1387, 1390 (Bd. Pat. App. & Inter. 1992) court emphasized included the ª`nature of the (Display of equipment including the structural activity that occurred in public; the public access to features of the claimed invention to visitors of and knowledge of the public use; [and] whether there laboratory is public use even though public did not were any con®dentiality obligations imposed on see inner workings of device. The person to whom persons who observed the use.'º Bernhardt, 386 the invention is publicly disclosed need not F.3d at 1381, 72 USPQ2d at 1909. For example, the understand the signi®cance and technical court in Bernhardt noted that an exhibition display complexities of the invention.). at issue in the case ªwas not open to the public, that the identi®cation of attendees was checked against 3. There Is No Public Use If Inventor Restricted Use a list of authorized names by building security and to Locations Where There Was a Reasonable later at a reception desk near the showroom, that attendees were escorted through the showroom, and that the attendees were not permitted to make written notes or take photographs inside the showroom.º

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Id. The court remanded the issue of whether the ordinary course of a business for trade or pro®t may exhibition display was a public use for further be a ªpublic use,º Bird Provision Co. v. Owens proceedings since the district court ªfocused on the Country Sausage, Inc., 568 F.2d 369, 374-76, 197 absence of any con®dentiality agreements and did USPQ 134, 138-40 (5th Cir. 1978). Additionally, not discuss or analyze how the totality of the even a ªsecretº use by another inventor of a machine circumstances surroundingº the exhibition ªcomports or process to make a product is ªpublicº if the details with the policies underlying the public use bar.º Id. of the machine or process are ascertainable by inspection or analysis of the product that is sold or B. Use by Third Parties Deriving the Invention from publicly displayed. Gillman v. Stern, 114 F.2d 28, Applicant 46 USPQ 430 (2d Cir. 1940); Dunlop Holdings, Ltd. v. Ram Golf Corp., 524 F.2d 33, 36-7, 188 An Invention Is in Public Use If the Inventor Allows USPQ 481, 483-484 (7th Cir. 1975). If the details Another To Use the Invention Without Restriction or of an inventive process are not ascertainable from Obligation of Secrecy the product sold or displayed and the third party has kept the invention as a trade secret then that use is ªPublic useº of a claimed invention under pre-AIA not a public use and will not bar a patent issuing to 35 U.S.C. 102(b) occurs when the inventor allows someone unconnected to the user. W.L. Gore & another person to use the invention without Assocs. v. Garlock, Inc., 721 F.2d 1540, 1550, 220 limitation, restriction or obligation of secrecy to the USPQ 303, 310 (Fed. Cir. 1983). However, a device inventor.º In re Smith, 714 F.2d 1127, 1134, 218 quali®es as prior art if it places the claimed features USPQ 976, 983 (Fed. Cir. 1983). The presence or in the public©s possession before the critical date absence of a con®dentiality agreement is not itself even if other unclaimed aspects of the device were determinative of the public use issue, but is one not publicly available. Lockwood v. American factor to be considered along with the time, place, Airlines, Inc., 41 USPQ2d 1961, 1964-65 (Fed. Cir. and circumstances of the use which show the amount 1997) (Computer reservation system was prior art of control the inventor retained over the invention. even though ªessential algorithms of the SABRE Moleculon Research Corp. v. CBS, Inc., 793 F.2d software were proprietary and con®dential 1261, 1265, 229 USPQ 805, 809 (Fed. Cir. 1986). and...those aspects of the system that were readily See Ex parte C, 27 USPQ2d 1492, 1499 (Bd. Pat. apparent to the public would not have been suf®cient App. & Inter. 1992) (Inventor sold inventive soybean to enable one skilled in the art to duplicate the seeds to growers who contracted and were paid to [unclaimed aspects of the] system.º). The extent that plant the seeds to increase stock for later sale. The the public becomes ªinformedº of an invention commercial nature of the use of the seed coupled involved in public use activity by one other than an with the ªon-saleº aspects of the contract and applicant depends upon the factual circumstances apparent lack of con®dentiality requirements rose surrounding the activity and how these comport with to the level of a ªpublic useº bar.); Egbert the policies underlying the on sale and public use v. Lippmann, 104 U.S. 333, 336 (1881) (Public use bars. Manville Sales Corp. v. Paramount Sys., Inc., found where inventor allowed another to use 917 F.2d 544, 549, 16 USPQ2d 1587, 1591 (Fed. inventive corset insert, though hidden from view Cir. 1990) (quoting King Instrument Corp. v. Otari during use, because he did not impose an obligation Corp., 767 F.2d 833, 860, 226 USPQ 402, 406 (Fed. of secrecy or restrictions on its use.). Cir. 1985)). By way of example, in an allegedly ªsecretº use by a third party other than an applicant, C. Use by Independent Third Parties if a large number of employees of such a party, who are not under a promise of secrecy, are permitted Use by an Independent Third Party Is Public Use If It unimpeded access to an invention, with af®rmative Suf®ciently ªInformsº the Public of the Invention or a steps by the party to educate other employees as to Competitor Could Reasonably Ascertain the Invention the nature of the invention, the public is ªinformed.º Chemithon Corp. v. Proctor & Gamble Co., 287 F. Any ªnonsecretº use of an invention by someone Supp. 291, 308, 159 USPQ 139, 154 (D.Md. 1968), unconnected to the inventor, such as someone who aff'd., 427 F.2d 893, 165 USPQ 678 (4th Cir. 1970). has independently made the invention, in the

Rev. 07.2015, October 2015 2100-86 PATENTABILITY § 2133.03(b)

Even if public use activity by one other than an I. THE MEANING OF ªSALEº applicant is not suf®ciently ªinforming,º there may be adequate grounds upon which to base a rejection A sale is a contract between parties wherein the seller under pre-AIA 35 U.S.C. 102(f) and pre-AIA 35 agrees ªto give and to pass rights of propertyº in U.S.C. 102(g). See Dunlop Holdings Ltd. v. Ram return for the buyer's payment or promise ªto pay Golf Corp., 524 F.2d 33, 188 USPQ 481 (7th Cir. the seller for the things bought or sold.º In re 1975). See MPEP § 2137 and § 2138. Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed. Cir. 1985). A contract for the sale of goods requires 2133.03(b) ªOn Saleº [R-11.2013] a concrete offer and acceptance of that offer. See, e.g., Linear Tech., 275 F.3d at 1052-54, 61 USPQ2d [Editor Note: This MPEP section is not applicable at 1233-34 (Court held there was no sale within the to applications subject to examination under the ®rst meaning of pre-AIA 35 U.S.C. 102(b) where inventor to ®le (FITF) provisions of the AIA as set prospective purchaser submitted an order for goods forth in 35 U.S.C. 100 (note) . See MPEP § 2159 et at issue, but received an order acknowledgement seq. to determine whether an application is subject reading ªwill advise-not booked.º Prospective to examination under the FITF provisions, and purchaser would understand that order was not MPEP § 2150 et seq. for examination of applications accepted.). subject to those provisions. See MPEP § 2152.02(c) through (e) for a detailed discussion of the public A. Conditional Sale May Bar a Patent use and on sale provisions of AIA 35 U.S.C. 102.] An invention may be deemed to be ªon saleº even An impermissible sale has occurred if there was a though the sale was conditional. The fact that the de®nite sale, or offer to sell, more than 1 year before sale is conditioned on buyer satisfaction does not, the effective ®ling date of the U.S. application and without more, prove that the sale was for an the subject matter of the sale, or offer to sell, fully experimental purpose. Strong v. General Elec. Co., anticipated the claimed invention or would have 434 F.2d 1042, 1046, 168 USPQ 8, 12 (5th Cir. rendered the claimed invention obvious by its 1970). addition to the prior art. Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1565, 33 USPQ2d 1512, 1514 (Fed. B. Nonpro®t Sale May Bar a Patent Cir. 1995). The on-sale bar of pre-AIA 35 U.S.C. 102(b) is triggered if the invention is both (1) the A ªsaleº need not be for pro®t to bar a patent. If the subject of a commercial offer for sale not primarily sale was for the commercial exploitation of the for experimental purposes and (2) ready for invention, it is ªon saleº within the meaning of patenting. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, pre-AIA 35 U.S.C. 102(b). In re Dybel, 524 F.2d 67, 48 USPQ2d 1641, 1646-47 (1998). Traditional 1393, 1401, 187 USPQ 593, 599 (CCPA 1975) contract law principles are applied when determining (ªAlthough selling the devices for a pro®t would whether a commercial offer for sale has occurred. have demonstrated the purpose of commercial See Linear Tech. Corp. v. Micrel, Inc., 275 F.3d exploitation, the fact that appellant realized no pro®t 1040, 1048, 61 USPQ2d 1225, 1229 (Fed. Cir. from the sales does not demonstrate the contrary.º). 2001), petition for cert. ®led, 71 USLW 3093 (July 03, 2002) (No. 02-39); Group One, Ltd. v. Hallmark C. A Single Sale or Offer To Sell May Bar a Patent Cards, Inc., 254 F.3d 1041,1047, 59 USPQ2d 1121, 1126 (Fed. Cir. 2001) (ªAs a general proposition, Even a single sale or offer to sell the invention may we will look to the Uniform Commercial Code bar patentability under pre-AIA 35 U.S.C. 102(b). (`UCC') to de®ne whether ¼ a communication or Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92, series of communications rises to the level of a 94 (1876); Atlantic Thermoplastics Co. v. Faytex commercial offer for sale.º). Corp., 970 F.2d 834, 836-37, 23 USPQ2d 1481, 1483 (Fed. Cir. 1992).

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D. A Sale of Rights Is Not a Sale of the Invention and A. Rejected or Unreceived Offer for Sale Is Enough Will Not in Itself Bar a Patent To Bar a Patent

ª[A]n assignment or sale of the rights in the Since the statute creates a bar when an invention is invention and potential patent rights is not a sale of placed ªon sale,º a mere offer to sell is suf®cient `the invention' within the meaning of [pre-AIA] commercial activity to bar a patent. In re Theis, 610 section 102(b).º Moleculon Research Corp. v. CBS, F.2d 786, 791, 204 USPQ 188, 192 (CCPA 1979). Inc., 793 F.2d 1261, 1267, 229 USPQ 805, 809 (Fed. Even a rejected offer may create an on sale bar. Cir. 1986); see also Elan Corp., PLC v. Andrx UMC Elecs. v. United States, 816 F.2d 647, 653, 2 Pharms. Inc., 366 F.3d 1336, 1341, 70 USPQ2d USPQ2d 1465, 1469 (Fed. Cir. 1987). In fact, the 1722, 1728 (Fed. Cir. 2004); In re Kollar, 286 F.3d offer need not even be actually received by a 1326, 1330 n.3, 1330-1331, 62 USPQ2d 1425, 1428 prospective purchaser. Wende v. Horine, 225 F. 501 n.3, 1428-1429 (Fed. Cir. 2002) (distinguishing (7th Cir. 1915). licenses which trigger the on-sale bar (e.g., a standard computer software license wherein the B. Delivery of the Offered Item Is Not Required product is just as immediately transferred to the licensee as if it were sold), from licenses that merely ªIt is not necessary that a sale be consummated for grant rights to an invention which do not per se the bar to operate.º Buildex v. Kason Indus., Inc., trigger the on-sale bar (e.g., exclusive rights to 849 F.2d 1461, 1463-64, 7 USPQ2d 1325, 1327-28 market the invention or potential patent rights)); (Fed. Cir. 1988) (citations omitted). See also Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d Weatherchem Corp. v. J.L. Clark Inc., 163 F.3d 1041, 1049 n. 2, 59 USPQ2d 1121, 1129 n. 2 (Fed. 1326, 1333, 49 USPQ2d 1001, 1006-07 (Fed. Cir. Cir. 2001). 1998) (A signed purchase agreement prior to the critical date constituted a commercial offer; it was E. Buyer Must Be Uncontrolled by the Seller or Offerer immaterial that there was no delivery of later patented caps and no exchange of money until after A sale or offer for sale must take place between critical date.). separate entities. In re Caveney, 761 F.2d 671, 676, 226 USPQ 1, 4 (Fed. Cir. 1985). ªWhere the parties C. Seller Need Not Have the Goods ªOn Handº When to the alleged sale are related, whether there is a the Offer for Sale Is Made statutory bar depends on whether the seller so controls the purchaser that the invention remains out Goods need not be ªon handº and transferred at the of the public's hands. Ferag AG v. Quipp, Inc., 45 time of the sale or offer. The date of the offer for F.3d 1562, 1566, 33 USPQ2d 1512, 1515 (Fed. Cir. sale is the effective date of the ªon saleº activity. J. 1995) (Where the seller is a parent company of the A. La Porte, Inc. v. Norfolk Dredging Co., 787 F.2d buyer company, but the President of the buyer 1577, 1582, 229 USPQ 435, 438 (Fed. Cir. 1986). company had ªessentially unfetteredº management However, the invention must be complete and ªready authority over the operations of the buyer company, for patentingº (see MPEP § 2133.03(c)) before the the sale was a statutory bar.). critical date. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67, 48 USPQ2d 1641, 1647 (1998). See also Micro II. OFFERS FOR SALE Chemical, Inc. v. Great Plains Chemical Co., 103 F.3d 1538, 1545, 41 USPQ2d 1238, 1243 (Fed. Cir. ªOnly an offer which rises to the level of a 1997) (The on-sale bar was not triggered by an offer commercial offer for sale, one which the other party to sell because the inventor ªwas not close to could make into a binding contract by simple completion of the invention at the time of the alleged acceptance (assuming consideration), constitutes an offer and had not demonstrated a high likelihood offer for sale under §102(b).º Group One, Ltd. v. that the invention would work for its intended Hallmark Cards, Inc., 254 F.3d 1041,1048, 59 purpose upon completion.º); Shatterproof Glass USPQ2d 1121, 1126 (Fed. Cir. 2001). Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 225 USPQ 634 (Fed. Cir. 1985) (Where there was no

Rev. 07.2015, October 2015 2100-88 PATENTABILITY § 2133.03(b)

evidence that the samples shown to the potential B. Inventor's Consent to the Sale Is Not a Prerequisite customers were made by the new process and To Finding an On Sale Bar apparatus, the offer to sell did not rise to the level of an on sale bar.). Compare Barmag Barmer If the invention was placed on sale by a third party Maschinenfabrik AG v. Murata Mach., Ltd., 731 who obtained the invention from the inventor, a F.2d 831, 221 USPQ 561 (Fed. Cir. 1984) (Where patent is barred even if the inventor did not consent a ªmake shiftº model of the inventive product was to the sale or have knowledge that the invention was shown to the potential purchasers in conjunction embodied in the sold article. Electric Storage with the offer to sell, the offer was enough to bar a Battery Co. v. Shimadzu, 307 U.S. 5, 41 USPQ 155 patent under pre-AIA 35 U.S.C. 102(b).). (1938); In re Blaisdell, 242 F.2d 779, 783, 113 USPQ 289, 292 (CCPA 1957); CTS Corp. v. Electro D. Material Terms of an Offer for Sale Must be Present Materials Corp. of America, 469 F. Supp. 801, 819, 202 USPQ 22, 38 (S.D.N.Y. 1979). ª[A] communication that fails to constitute a de®nite offer to sell the product and to include material terms C. Objective Evidence of Sale or Offer To Sell Is is not an `offer' in the contract sense.º Elan Corp., Needed PLC v. Andrx Pharms. Inc., 366 F.3d 1336, 1341, 70 USPQ2d 1722, 1728 (Fed. Cir. 2004). The court In determining if a sale or offer to sell the claimed stated that an ªoffer to enter into a license under a invention has occurred, a key question to ask is patent for future sale of the invention covered by the whether the inventor sold or offered for sale a patent when and if it has been developed... is not an product that embodies the invention claimed in the offer to sell the patented invention that constitutes application. Objective evidence such as a description an on-sale bar.º Id., 70 USPQ2d at 1726. of the inventive product in the contract of sale or in Accordingly, the court concluded that Elan's letter another communication with the purchaser controls was not an offer to sell a product. In addition, the over an uncommunicated intent by the seller to court stated that the letter lacked material terms of deliver the inventive product under the contract for a commercial offer such as pricing for the product, sale. Ferag AG v. Quipp, Inc., 45 F.3d 1562, 1567, quantities, time and place of delivery, and product 33 USPQ2d 1512, 1516 (Fed. Cir. 1995) (On sale speci®cations and that the dollar amount in the letter bar found where initial negotiations and agreement was not a price term for the sale of the product but containing contract for sale neither clearly speci®ed rather the amount requested was to form and nor precluded use of the inventive design, but an continue a partnership, explicitly referred to as a order con®rmation prior to the critical date did ªlicensing fee.º Id. specify use of inventive design.). The purchaser need not have actual knowledge of the invention for it to III. SALE BY INVENTOR, ASSIGNEE OR OTHERS be on sale. The determination of whether ªthe offered ASSOCIATED WITH THE INVENTOR IN THE product is in fact the claimed invention may be COURSE OF BUSINESS established by any relevant evidence, such as memoranda, drawings, correspondence, and A. Sale Activity Need Not Be Public testimony of witnesses.º RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1060, 12 USPQ2d 1449, 1452 Unlike questions of public use, there is no (Fed. Cir. 1989). However, ªwhat the purchaser requirement that ªon saleº activity be ªpublic.º reasonably believes the inventor to be offering is ªPublicº as used in pre-AIA 35 U.S.C. 102(b) relevant to whether, on balance, the offer objectively modi®es ªuseº only. ªPublicº does not modify may be said to be of the patented invention.º ªsale.º Hobbs v. United States, 451 F.2d 849, 171 Envirotech Corp. v. Westech Eng'g, Inc., 904 F.2d USPQ 713, 720 (5th Cir. 1971). 1571, 1576, 15 USPQ2d 1230, 1234 (Fed. Cir. 1990) (Where a proposal to supply a general contractor with a product did not mention a new design but, rather, referenced a prior art design, the uncommunicated intent of the supplier to supply the

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new design if awarded the contract did not constitute examination of applications subject to those an ªon saleº bar to a patent on the new design, even provisions. See MPEP § 2152.02(c) through (e) for though the supplier's bid re¯ected the lower cost of a detailed discussion of the public use and on sale the new design.). provisions of AIA 35 U.S.C. 102.]

Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty IV. SALES BY INDEPENDENT THIRD PARTIES and loss of right to patent.

A. Sales or Offers for Sale by Independent Third A person shall be entitled to a patent unless - Parties Will Bar a Patent ***** Sale or offer for sale of the invention by an (b) the invention was¼in public use or on sale in this independent third party more than 1 year before the country, more than one year prior to the date of the application ®ling date of applicant's patent will bar applicant for patent in the United States from obtaining a patent. ªAn exception to this rule ***** exists where a patented method is kept secret and remains secret after a sale of the unpatented product (Emphasis added). of the method. Such a sale prior to the critical date is a bar if engaged in by the patentee or patent I. THE INVENTION MUST BE ªREADY FOR PATENTINGº applicant, but not if engaged in by another.º In re Caveney, 761 F.2d 671, 675-76, 226 USPQ 1, 3-4 (Fed. Cir. 1985). In Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 66-68, 48 USPQ2d 1641, 1647 (1998), the Supreme Court enunciated a two-prong test for determining whether B. Nonprior Art Publications Can Be Used as Evidence of Sale Before the Critical Date an invention was ªon saleº within the meaning of pre-AIA 35 U.S.C. 102(b) even if it has not yet been Abstracts identifying a product's vendor containing reduced to practice. ª[T]he on-sale bar applies when information useful to potential buyers such as whom two conditions are satis®ed before the critical date to contact, price terms, documentation, warranties, [more than one year before the effective ®ling date training and maintenance along with the date of of the U.S. application]. First, the product must be product release or installation before the inventor's the subject of a commercial offer for sale¼. Second, critical date may provide suf®cient evidence of prior the invention must be ready for patenting.º Id. at sale by a third party to support a rejection based on 67, 119 S.Ct. at 311-12, 48 USPQ2d at 1646-47. pre-AIA 35 U.S.C. 102(b) or 103. In re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994) The Federal Circuit explained that the Supreme (Examiner©s rejection was based on nonprior art Court's ªready for patentingº prong applies in the published abstracts which disclosed software context of both the on sale and public use bars. products meeting the claims. The abstracts speci®ed Invitrogen Corp. v. Biocrest Manufacturing L.P., software release dates and dates of ®rst installation 424 F.3d 1374, 1379, 76 USPQ2d 1741, 1744 (Fed. which were more than 1 year before applicant's Cir. 2005) (ªA bar under [pre-AIA] section 102(b) ®ling date.). arises where, before the critical date, the invention is in public use and ready for patenting.º). ªReady 2133.03(c) The ªInventionº [R-11.2013] for patenting,º the second prong of the Pfaff test, ªmay be satis®ed in at least two ways: by proof of reduction to practice before the critical date; or by [Editor Note: This MPEP section has limited proof that prior to the critical date the inventor had applicability to applications subject to examination prepared drawings or other descriptions of the under the ®rst inventor to ®le (FITF) provisions of invention that were suf®ciently speci®c to enable a the AIA as set forth in 35 U.S.C. 100 (note). See person skilled in the art to practice the invention.º MPEP § 2159 et seq. to determine whether an Id. at 67, 199 S.Ct. at 311-12, 48 USPQ2d at 1647 application is subject to examination under the FITF (The patent was held invalid because the invention provisions, and MPEP § 2150 et seq. for for a computer chip socket was ªready for patentingº

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when it was offered for sale more than one year prior playing and handling characteristics.º ªSubjective to the application ®ling date. Even though the qualities inherent in a product, such as `improved invention had not yet been reduced to practice, the playing and handling', cannot serve as an escape manufacturer was able to produce the claimed hatch to circumvent an on-sale bar.º). Actual computer chip sockets using the inventor's detailed reduction to practice in the context of an on-sale bar drawings and speci®cations, and those sockets issue usually requires testing under actual working contained all elements of invention claimed in the conditions in such a way as to demonstrate the patent.). See also Weatherchem Corp. v. J.L. Clark practical utility of an invention for its intended Inc., 163 F.3d 1326, 1333, 49 USPQ2d 1001, purpose beyond the probability of failure, unless by 1006-07 (Fed. Cir. 1998) (The invention was held virtue of the very simplicity of an invention its ªready for patentingº since the detailed drawings of practical operativeness is clear. Field v. Knowles, plastic dispensing caps offered for sale ªcontained 183 F.2d 593, 601, 86 USPQ 373, 379 (CCPA 1950); each limitation of the claims and were suf®ciently Steinberg v. Seitz, 517 F.2d 1359, 1363, 186 USPQ speci®c to enable person skilled in art to practice 209, 212 (CCPA 1975). the inventionº.). The invention need not be ready for satisfactory If the invention was actually reduced to practice commercial marketing for sale to bar a patent. before being sold or offered for sale more than 1 Atlantic Thermoplastics Co. v. Faytex Corp., 970 year before ®ling of the application, a patent will be F.2d 834, 836-37, 23 USPQ2d 1481, 1483 (Fed. Cir. barred. Vanmoor v. Wal-Mart Stores, Inc., 201 F.3d 1992). 1363, 1366-67, 53 USPQ2d 1377, 1379 (Fed. Cir. 2000) (ªHere the pre-critical date sales were of II. INVENTOR HAS SUBMITTED A 37 CFR 1.131 completed cartridges made to speci®cations that AFFIDAVIT OR DECLARATION remained unchanged to the present day, showing that any invention embodied in the accused Af®davits or declarations submitted under 37 CFR cartridges was reduced to practice before the critical 1.131 to swear behind a reference may constitute, date. The Pfaff ready for patenting condition is also among other things, an admission that an invention satis®ed because the speci®cation drawings, was ªcompleteº more than 1 year before the ®ling available prior to the critical date, were actually used of an application. See In re Foster, 343 F.2d 980, to produce the accused cartridges.º); In re Hamilton, 987-88, 145 USPQ 166, 173 (CCPA 1965); Dart 882 F.2d 1576, 1580, 11 USPQ2d 1890, 1893 (Fed. Indus. v. E.I. duPont de Nemours & Co., 489 F.2d Cir. 1989). ªIf a product that is offered for sale 1359, 1365, 179 USPQ 392, 396 (7th Cir. 1973). inherently possesses each of the limitations of the Also see MPEP § 715.10. claims, then the invention is on sale, whether or not the parties to the transaction recognize that the III. SALE OF A PROCESS product possesses the claimed characteristics.º Abbott Laboratories v. Geneva A claimed process, which is a series of acts or steps, Pharmaceuticals, Inc., 182 F.3d 1315, 1319, 51 is not sold in the same sense as is a claimed product, USPQ2d 1307, 1310 (Fed. Cir. 1999) (Claim for a device, or apparatus, which is a tangible item. particular anhydrous crystalline form of a ª`Know-how' describing what the process consists pharmaceutical compound was held invalid under of and how the process should be carried out may the on-sale bar of pre-AIA 35 U.S.C. 102(b), even be sold in the sense that the buyer acquires though the parties to the U.S. sales of the foreign knowledge of the process and obtains the freedom manufactured compound did not know the identity to carry it out pursuant to the terms of the of the particular crystalline form.); STX LLC. v. transaction. However, such a transaction is not a Brine Inc., 211 F.3d 588, 591, 54 USPQ2d 1347, `sale' of the invention within the meaning of 1350 (Fed. Cir. 2000) (Claim for a lacrosse stick [pre-AIA] §102(b) because the process has not been was held invalid under the on-sale bar despite the carried out or performed as a result of the argument that it was not known at the time of sale transaction.º In re Kollar, 286 F.3d 1326, 1332, whether the sticks possessed the recited ªimproved 62 USPQ2d 1425, 1429 (Fed. Cir. 2002). However,

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sale of a product made by the claimed process by forth in 35 U.S.C. 100 (note). See MPEP § 2159 et the patentee or a licensee would constitute a sale of seq. to determine whether an application is subject the process within the meaning of pre-AIA 35 U.S.C. to examination under the FITF provisions, and 102(b). See id. at 1333, 62 USPQ2d at 1429; D.L. MPEP § 2150 et seq. for examination of applications Auld Co. v. Chroma Graphics Corp., 714 F.2d 1144, subject to those provisions. See MPEP § 2152.02(c) 1147-48, 219 USPQ 13, 15-16 (Fed. Cir. 1983) through (e) for a detailed discussion of the public (Even though the sale of a product made by a use and on sale provisions of AIA 35 U.S.C. 102.] claimed method before the critical date did not reveal anything about the method to the public, the sale For purposes of judging the applicability of the resulted in a ªforfeitureº of any right to a patent to pre-AIA 35 U.S.C. 102(b) bars, public use or on sale that method); W.L. Gore & Assocs., Inc. v. Garlock, activity must take place in the United States. The Inc., 721 F.2d 1540, 1550, 220 USPQ 303, 310 (Fed. ªon saleº bar does not generally apply where both Cir. 1983). The application of pre-AIA 35 U.S.C. manufacture and delivery occur in a foreign country. 102(b) would also be triggered by actually Gandy v. Main Belting Co., 143 U.S. 587, 593 performing the claimed process itself for (1892). However, ªon saleº status can be found if consideration. See Scaltech, Inc. v. Retec/Tetra, substantial activity prefatory to a ªsaleº occurs in L.L.C., 269 F.3d 1321, 1328, 60 USPQ2d 1687, the United States. Robbins Co. v. Lawrence Mfg. 1691(Fed. Cir. 2001) (Patent was held invalid under Co., 482 F.2d 426, 433, 178 USPQ 577, 583 (9th pre-AIA 35 U.S.C. 102(b) based on patentee's offer Cir. 1973). An offer for sale, made or originating in to perform the claimed process for treating oil this country, may be suf®cient prefatory activity to re®nery waste more than one year before ®ling the bring the offer within the terms of the statute, even patent application). Moreover, the sale of a device though sale and delivery take place in a foreign embodying a claimed process may trigger the on-sale country. The same rationale applies to an offer by a bar. Minton v. National Ass'n. of Securities Dealers, foreign manufacturer which is communicated to a Inc., 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1618 prospective purchaser in the United States prior to (Fed. Cir. 2003) (®nding a fully operational the critical date. CTS Corp. v. Piher Int'l Corp., 593 computer program implementing and thus F.2d 777, 201 USPQ 649 (7th Cir. 1979). embodying the claimed method to trigger the on-sale bar). However, the sale of a prior art device different 2133.03(e) Permitted Activity; Experimental from that disclosed in a patent that is asserted after Use [R-11.2013] the critical date to be capable of performing the claimed method is not an on-sale bar of the process. [Editor Note: This MPEP section is not applicable Poly-America LP v. GSE Lining Tech. Inc., 383 to applications subject to examination under the ®rst F.3d 1303, 1308-09, 72 USPQ2d 1685, 1688-89 inventor to ®le (FITF) provisions of the AIA as set (Fed. Cir. 2004) (stating that the transaction forth in 35 U.S.C. 100 (note). See MPEP § 2159 et involving the sale of the prior art device did not seq. to determine whether an application is subject involve a transaction of the claimed method but to examination under the FITF provisions, and instead only a device different from that described MPEP § 2150 et seq. for examination of applications in the patent for carrying out the claimed method, subject to those provisions. See MPEP § 2152.02(c) where the device was not used to practice the through (e) for a detailed discussion of the public claimed method until well after the critical date, and use and on sale provisions of AIA 35 U.S.C. 102.] where there was evidence that it was not even known whether the device could perform the claimed The question posed by the experimental use doctrine process). is ªwhether the primary purpose of the inventor at the time of the sale, as determined from an objective 2133.03(d) ªIn This Countryº [R-11.2013] evaluation of the facts surrounding the transaction, was to conduct experimentation.º Allen Eng'g Corp. [Editor Note: This MPEP section is not applicable v. Bartell Indus., Inc., 299 F.3d 1336, 1354, 63 to applications subject to examination under the ®rst USPQ2d 1769, 1780 (Fed. Cir. 2002) (quoting EZ inventor to ®le (FITF) provisions of the AIA as set Dock v. Schafer Sys., Inc., 276 F.3d 1347, 1356-57,

Rev. 07.2015, October 2015 2100-92 PATENTABILITY § 2133.03(e)(1)

61 USPQ2d 1289, 1295-96 (Fed. Cir. 2002)) (Linn, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA J., concurring). Experimentation must be the primary 1979). purpose and any commercial exploitation must be incidental. I. THE COMMERCIAL ACTIVITY MUST LEGITIMATELY ADVANCE DEVELOPMENT OF If the use or sale was experimental, there is no bar THE INVENTION TOWARDS COMPLETION under pre-AIA 35 U.S.C. 102(b). ªA use or sale is experimental for purposes of pre-AIA section 102(b) As the degree of commercial exploitation if it represents a bona ®de effort to perfect the surrounding pre-AIA 35 U.S.C. 102(b) activity invention or to ascertain whether it will answer its increases, the burden on an applicant to establish intended purpose.¼ If any commercial exploitation clear and convincing evidence of experimental does occur, it must be merely incidental to the activity with respect to a public use becomes more primary purpose of the experimentation to perfect dif®cult. Where the examiner has found a prima the invention.º LaBounty Mfg. v. United States Int'l facie case of a sale or an offer to sell, this burden Trade Comm'n, 958 F.2d 1066, 1071, 22 USPQ2d will rarely be met unless clear and convincing 1025, 1028 (Fed. Cir. 1992) (quoting Pennwalt necessity for the experimentation is established by Corp. v. Akzona Inc., 740 F.2d 1573, 1581, 222 the applicant. This does not mean, of course, that USPQ 833, 838 (Fed. Cir. 1984)). ªThe experimental there are no circumstances which would permit use exception¼does not include market testing alleged experimental activity in an atmosphere of where the inventor is attempting to gauge consumer commercial exploitation. In certain circumstances, demand for his claimed invention. The purpose of even a sale may be necessary to legitimately advance such activities is commercial exploitation and not the experimental development of an invention if the experimentation.º In re Smith, 714 F.2d 1127, 1134, primary purpose of the sale is experimental. In re 218 USPQ 976, 983 (Fed. Cir. 1983). Theis, 610 F.2d 786, 793, 204 USPQ 188, 194 (CCPA 1979); Robbins Co. v. Lawrence Mfg. Co., 2133.03(e)(1) Commercial Exploitation 482 F.2d 426, 433, 178 USPQ 577, 582 (9th Cir. [R-11.2013] 1973). However, careful scrutiny by the examiner of the objective factual circumstances surrounding such a sale is essential. See Ushakoff v. United [Editor Note: This MPEP section is not applicable States, 327 F.2d 669, 140 USPQ 341 (Ct.Cl. 1964); to applications subject to examination under the ®rst Cloud v. Standard Packaging Corp., 376 F.2d 384, inventor to ®le (FITF) provisions of the AIA as set 153 USPQ 317 (7th Cir. 1967). forth in 35 U.S.C. 100 (note). See MPEP § 2159 et seq. to determine whether an application is subject II. SIGNIFICANT FACTORS INDICATIVE OF to examination under the FITF provisions, and ªCOMMERCIAL EXPLOITATIONº MPEP § 2150 et seq. for examination of applications subject to those provisions. See MPEP § 2152.02(c) As discussed in MPEP § 2133.03, a policy through (e) for a detailed discussion of the public consideration in questions of pre-AIA 35 U.S.C. use and on sale provisions of AIA 35 U.S.C. 102.] 102(b) activity is premature ªcommercial exploitationº of a ªcompletedº or ªready for One policy of the on sale and public use bars is the patentingº invention (see MPEP § 2133.03(c)). The prevention of inventors from exploiting their extent of commercial activity which constitutes inventions commercially more than 1 year prior to pre-AIA 35 U.S.C. 102(b) ªon saleº status depends the ®ling of a patent application. Therefore, if upon the circumstances of the activity, the basic applicant's precritical date activity is a sale or offer indicator being the subjective intent of the inventor for sale that is an attempt at market penetration, a as manifested through objective evidence. The patent is barred. Thus, even if there is bona ®de following activities should be used by the examiner experimental activity, an inventor may not as indicia of this subjective intent: commercially exploit an invention more than 1 year prior to the ®ling date of an application. In re Theis,

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(A) Preparation of various contemporaneous See MPEP § 2133.03(e)(4) for factors indicative of ªcommercialº documents, e.g., orders, invoices, an experimental purpose. receipts, delivery schedules, etc.; (B) Preparation of price lists (Akron 2133.03(e)(2) Intent [R-11.2013] Brass Co. v. Elkhart Brass Mfg. Co., 353 F.2d 704, 709, 147 USPQ 301, 305 (7th Cir. 1965) and [Editor Note: This MPEP section is not applicable distribution of price quotations (Amphenol Corp. v. to applications subject to examination under the ®rst General. Time Corp., 158 USPQ 113, 117 (7th Cir. inventor to ®le (FITF) provisions of the AIA as set 1968)); forth in 35 U.S.C. 100 (note). See MPEP § 2159 et (C) Display of samples to prospective customers seq. to determine whether an application is subject (Cataphote Corp. v. DeSoto Chemical to examination under the FITF provisions, and Coatings, Inc., 356 F.2d 24, 27, 148 USPQ 527, 529 MPEP § 2150 et seq. for examination of applications (9th Cir. 1966) mod. on other grounds, 358 F.2d subject to those provisions. See MPEP § 2152.02(c) 732, 149 USPQ 159 (9th Cir.), cert. denied, 385 through (e) for a detailed discussion of the public U.S. 832 (1966); Chicopee Mfg. Corp. v. Columbus use and on sale provisions of AIA 35 U.S.C. 102.] Fiber Mills Co., 165 F.Supp. 307, 323-325, 118 USPQ 53, 65-67 (M.D.Ga. 1958)); ªWhen sales are made in an ordinary commercial environment and the goods are placed outside the (D) Demonstration of models or prototypes inventor's control, an inventor's secretly held (General Elec. Co. v. United States, 206 USPQ 260, subjective intent to `experiment,' even if true, is 266-67 (Ct. Cl. 1979); Red Cross Mfg. v. Toro Sales unavailing without objective evidence to support the Co., 525 F.2d 1135, 1140, 188 USPQ 241, 244-45 contention. Under such circumstances, the customer (7th Cir. 1975); Philco Corp. v. Admiral Corp., 199 at a minimum must be made aware of the F. Supp. 797, 815-16, 131 USPQ 413, 429-30 experimentation.º LaBounty Mfg., Inc. v. United (D.Del. 1961)), especially at trade conventions States Int'l Trade Comm'n, 958 F.2d 1066, 1072, (InterRoyal Corp. v. Simmons Co., 204 USPQ 562, 22 USPQ2d 1025, 1029 (Fed. Cir. 1992) (quoting 563-65 (S.D. N.Y. 1979)), and even though no orders Harrington Mfg. Co. v. Powell Mfg. Co., 815 F.2d are actually obtained (Monogram Mfg. v. F. & H. 1478, 1480 n.3, 2 USPQ2d 1364, 1366 n.3 (Fed. Cir. Mfg., 144 F.2d 412, 62 USPQ 409, 412 (9th Cir. 1986); Paragon Podiatry Laboratory, Inc. v. KLM 1944)); Labs., Inc., 984 F.2d 1182, 25 USPQ2d 1561 (Fed. (E) Use of an invention where an admission fee Cir. 1993) (Paragon sold the inventive units to the is charged (In re Josserand, 188 F.2d 486, 491, 89 trade as completed devices without any disclosure USPQ 371, 376 (CCPA 1951); Greenewalt v. to either doctors or patients of their involvement in Stanley, 54 F.2d 195, 12 USPQ 122 (3d Cir. 1931)); alleged testing. Evidence of the inventor's secretly and held belief that the units were not durable and may (F) Advertising in publicity releases, brochures, not be satisfactory for consumers was not suf®cient, and various periodicals (In re Theis, 610 F.2d 786, alone, to avoid a statutory bar.). 792 n.6, 204 USPQ 188, 193 n. 6 (CCPA 1979); InterRoyal Corp. v. Simmons Co., 204 USPQ 562, 2133.03(e)(3) ªCompletenessº of the 564-66 (S.D.N.Y.1979); Akron Brass, Inc. v. Elkhart Invention [R-11.2013] Brass Mfg., Inc., 353 F.2d 704, 709, 147 USPQ 301, 305 (7th Cir.1965); Tucker Aluminum Prods. v. [Editor Note: This MPEP section is not applicable Grossman, 312 F.2d 393, 394, 136 USPQ 244, 245 to applications subject to examination under the ®rst (9th Cir. 1963)). inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et seq. to determine whether an application is subject to examination under the FITF provisions, and MPEP § 2150 et seq. for examination of applications subject to those provisions. See MPEP § 2152.02(c)

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through (e) for a detailed discussion of the public reasonable disposal of a prototype involves use and on sale provisions of AIA 35 U.S.C. 102.] incidental income is not necessarily fatal. In re Dybel, 524 F.2d 1393, 1399, n.5, 187 USPQ 593, I. EXPERIMENTAL USE ENDS WHEN THE 597 n.5 (CCPA 1975). However, if a prototype is INVENTION IS ACTUALLY REDUCED TO considered ªcompleteº by an inventor and all PRACTICE experimentation on the underlying invention has ceased, unrestricted disposal of the prototype Experimental use ªmeans perfecting or completing constitutes a bar under pre-AIA 35 U.S.C. 102(b). an invention to the point of determining that it will In re Blaisdell, 242 F.2d 779, 113 USPQ 289 work for its intended purpose.º Therefore, (CCPA 1957); contra, Watson v. Allen, 254 F.2d experimental use ªends with an actual reduction to 342, 117 USPQ 68 (D.C. Cir. 1958). practice.º RCA Corp. v. Data Gen. Corp., 887 F.2d 1056, 1061, 12 USPQ2d 1449, 1453 (Fed. Cir. 2133.03(e)(4) Factors Indicative of an 1989). If the examiner concludes from the evidence Experimental Purpose [R-11.2013] of record that an applicant was satis®ed that an invention was in fact ªcomplete,º awaiting approval [Editor Note: This MPEP section is not applicable by the applicant from an organization such as to applications subject to examination under the ®rst Underwriters' Laboratories will not normally inventor to ®le (FITF) provisions of the AIA as set overcome this conclusion. InterRoyal Corp. v. forth in 35 U.S.C. 100 (note). See MPEP § 2159 et Simmons Co., 204 USPQ 562, 566 (S.D.N.Y. 1979); seq. to determine whether an application is subject Skil Corp. v. Rockwell Manufacturing Co., 358 F. to examination under the FITF provisions, and Supp. 1257, 1261, 178 USPQ 562, 565 (N.D.Ill. MPEP § 2150 et seq. for examination of applications 1973), aff'd. in part, rev'd in part sub nom. Skil subject to those provisions. See MPEP § 2152.02(c) Corp. v. Lucerne Products Inc., 503 F.2d 745, 183 through (e) for a detailed discussion of the public USPQ 396, 399 (7th Cir. 1974), cert. denied, 420 use and on sale provisions of AIA 35 U.S.C. 102.] U.S. 974, 185 USPQ 65 (1975). See MPEP § 2133.03(c) for more information of what The courts have considered a number of factors in constitutes a ªcompleteº invention. determining whether a claimed invention was the subject of a commercial offer for sale primarily for The fact that alleged experimental activity does not purposes of experimentation. ªThese factors include: lead to speci®c modi®cations or re®nements of an (1) the necessity for public testing, (2) the amount invention is evidence, although not conclusive of control over the experiment retained by the evidence, that such activity is not within the realm inventor, (3) the nature of the invention, (4) the permitted by the statute. This is especially the case length of the test period, (5) whether payment was where the evidence of record clearly demonstrates made, (6) whether there was a secrecy obligation, to the examiner that an invention was considered (7) whether records of the experiment were kept, (8) ªcompleteº by an inventor at the time of the activity. who conducted the experiment, ... (9) the degree of Nevertheless, any modi®cations or re®nements commercial exploitation during testing[,] ... (10) which did result from such experimental activity whether the invention reasonably requires evaluation must at least be a feature of the claimed invention under actual conditions of use, (11) whether testing to be of any probative value. In re Theis, 610 F.2d was systematically performed, (12) whether the 786, 793, 204 USPQ 188, 194 (CCPA 1979). inventor continually monitored the invention during testing, and (13) the nature of contacts made with II. DISPOSAL OF PROTOTYPES potential customers.º Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1353, 63 USPQ2d 1769, Where a prototype of an invention has been disposed 1780 (Fed. Cir. 2002) (quoting EZ Dock v. Schafer of by an inventor before the critical date, inquiry by Sys., Inc., 276 F.3d 1347, 1357, 61 USPQ2d 1289, the examiner should focus upon the intent of the 1296 (Fed. Cir. 2002)) (Linn, J., concurring). inventor and the reasonableness of the disposal under Another critical attribute of experimentation is the all circumstances. The fact that an otherwise ªcustomer's awareness of the purported testing in

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the context of a sale.º Electromotive Div. of Gen. unrestricted subsequent use of the invention is a Motors Corp. v. Transportation Sys. Div. of Gen. pre-AIA 35 U.S.C. 102(b) bar. In re Blaisdell, 242 Elec. Co., 417 F.3d 1203, 1241, 75 USPQ2d 1650, F.2d 779, 784, 113 USPQ 289, 293 (CCPA 1957). 1658 (Fed. Cir. 2005). 2133.03(e)(6) Permitted Experimental Once alleged experimental activity is advanced by Activity and Testing [R-11.2013] an applicant to explain a prima facie case under pre-AIA 35 U.S.C. 102(b), the examiner must [Editor Note: This MPEP section is not applicable determine whether the scope and length of the to applications subject to examination under the ®rst activity were reasonable in terms of the experimental inventor to ®le (FITF) provisions of the AIA as set purpose intended by the applicant and the nature of forth in 35 U.S.C. 100 (note). See MPEP § 2159 et the subject matter involved. No one of, or particular seq. to determine whether an application is subject combination of, factors is necessarily determinative to examination under the FITF provisions, and of this purpose. MPEP § 2150 et seq. for examination of applications subject to those provisions. See MPEP § 2152.02(c) See MPEP § 2133.03(e)(1) for factors indicative of through (e) for a detailed discussion of the public commercial exploitation. use and on sale provisions of AIA 35 U.S.C. 102.]

2133.03(e)(5) Experimentation and Degree I. DEVELOPMENTAL TESTING IS PERMITTED of Supervision and Control [R-11.2013] Testing of an invention in the normal context of its [Editor Note: This MPEP section is not applicable technological development is generally within the to applications subject to examination under the ®rst realm of permitted experimental activity. Likewise, inventor to ®le (FITF) provisions of the AIA as set experimentation to determine utility, as that term forth in 35 U.S.C. 100 (note). See MPEP § 2159 et is applied in 35 U.S.C. 101, may also constitute seq. to determine whether an application is subject permissible activity. See General Motors Corp. v. to examination under the FITF provisions, and Bendix Aviation Corp., 123 F. Supp. 506, 521, 102 MPEP § 2150 et seq. for examination of applications USPQ 58, 69 (N.D.Ind. 1954). For example, where subject to those provisions. See MPEP § 2152.02(c) an invention relates to a chemical composition with through (e) for a detailed discussion of the public no known utility, i.e., a patent application for the use and on sale provisions of AIA 35 U.S.C. 102.] composition could not be ®led (35 U.S.C. 101; 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst THE INVENTOR MUST MAINTAIN SUFFICIENT paragraph), continued testing to ®nd utility would CONTROL OVER THE INVENTION DURING likely be permissible under pre-AIA 35 U.S.C. TESTING BY THIRD PARTIES 102(b), absent a sale of the composition or other evidence of commercial exploitation. The signi®cant determinative factors in questions of experimental purpose are the extent of supervision II. MARKET TESTING IS NOT PERMITTED and control maintained by an inventor over an invention during an alleged period of Experimentation to determine product acceptance, experimentation , and the customer's awareness of i.e., market testing, is typical of a trader's and not the experimentation. Electromotive Div. of Gen. an inventor's experiment and is thus not within the Motors Corp. v. Transportation Sys. Div. of Gen. area of permitted experimental activity. Smith & Elec. Co., 417 F.3d 1203, 1214,75 USPQ2d 1650, Davis Mfg. Co. v. Mellon, 58 F. 705, 707 (8th Cir. 1658 (Fed. Cir. 2005)(ªcontrol and customer 1893) Likewise, testing of an invention for the awareness ordinarily must be proven if bene®t of appeasing a customer, or to conduct experimentation is to be foundº). Once a period of ªminor `tune up' procedures not requiring an experimental activity has ended and supervision and inventor's skills, but rather the skills of a competent control has been relinquished by an inventor without technician,º are also not within the exception. In re any restraints on subsequent use of an invention, an

Rev. 07.2015, October 2015 2100-96 PATENTABILITY § 2134

Theis, 610 F.2d 786, 793, 204 USPQ 188, 193-94 206, 210 (S.D. Fla. 1951), aff©d., 207 F.2d 173, 98 (CCPA 1979). USPQ 205 (5th Cir. 1953), cert. denied, 346 U.S. 897, 99 USPQ 490 (1953); contra, Watson v. Allen, III. EXPERIMENTAL ACTIVITY IN THE 254 F.2d 342, 117 USPQ 68 (D.C.Cir. 1957). In CONTEXT OF DESIGN APPLICATIONS other words, the experimental use activity exception is personal to an applicant. The public use of an ornamental design which is directed toward generating consumer interest in the 2134 Pre-AIA 35 U.S.C. 102(c) [R-11.2013] aesthetics of the design is not an experimental use. In re Mann, 861 F.2d 1581, 8 USPQ2d 2030 (Fed. [Editor Note: This MPEP section is not applicable Cir. 1988) (display of a wrought iron table at a trade to applications subject to examination under the ®rst show held to be public use). However, inventor to ®le (FITF) provisions of the AIA as set ªexperimentation directed to functional features of forth in 35 U.S.C. 100 (note). See MPEP § 2159 et a product also containing an ornamental design may seq. to determine whether an application is subject negate what otherwise would be considered a public to examination under the FITF provisions, and use within the meaning of section 102(b).º Tone MPEP § 2150 et seq. for examination of applications Brothers, Inc. v. Sysco Corp., 28 F.3d 1192, 1196, subject to those provisions.] 31 USPQ2d 1321, 1326 (Fed. Cir. 1994) (A study wherein students evaluated the effect of the Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty functional features of a spice container design may and loss of right to patent. be considered an experimental use.). A person shall be entitled to a patent unless -

2133.03(e)(7) Activity of an Independent ***** Third Party Inventor [R-11.2013] (c) he has abandoned the invention. ***** [Editor Note: This MPEP section is not applicable to applications subject to examination under the ®rst I. UNDER 35 U.S.C. 102(c), AN ABANDONMENT inventor to ®le (FITF) provisions of the AIA as set MUST BE INTENTIONAL forth in 35 U.S.C. 100 (note) . See MPEP § 2159 et seq. to determine whether an application is subject ªActual abandonment under pre-AIA 35 U.S.C. to examination under the FITF provisions, and 102(c) requires that the inventor intend to abandon MPEP § 2150 et seq. for examination of applications the invention, and intent can be implied from the subject to those provisions. See MPEP § 2152.02(c) inventor's conduct with respect to the invention. In through (e) for a detailed discussion of the public re Gibbs, 437 F.2d 486, 168 USPQ 578 (CCPA use and on sale provisions of AIA 35 U.S.C. 102.] 1971). Such intent to abandon the invention will not be imputed, and every reasonable doubt should be EXPERIMENTAL USE EXCEPTION IS PERSONAL resolved in favor of the inventor.º Ex parte Dunne, TO AN APPLICANT 20 USPQ2d 1479 (Bd. Pat. App. & Inter. 1991).

The statutory bars of pre-AIA 35 U.S.C. 102(b) are II. DELAY IN MAKING FIRST APPLICATION applicable even though public use or on sale activity is by a party other than an applicant. Where an Abandonment under pre-AIA 35 U.S.C. 102(c) applicant presents evidence of experimental activity requires a deliberate, though not necessarily express, by such other party, the evidence will not overcome surrender of any rights to a patent. To abandon the the prima facie case under pre-AIA 35 U.S.C. invention the inventor must intend a dedication to 102(b) based upon the activity of such party unless the public. Such dedication may be either express the activity was under the supervision and control or implied, by actions or inactions of the inventor. of the applicant. Magnetics v. Arnold Eng'g Co., Delay alone is not suf®cient to infer the requisite 438 F.2d 72, 74, 168 USPQ 392, 394 (7th Cir. 1971), intent to abandon. Moore v. United States, 194 Bourne v. Jones, 114 F.Supp. 413, 419, 98 USPQ USPQ 423, 428 (Ct. Cl. 1977) (The drafting and

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retention in his own ®les of two patent applications under pre-AIA 35 U.S.C. 102(g) and applicant by inventor indicates an intent to retain his invention; abandons, suppresses or conceals the invention. delay in ®ling the applications was not suf®cient to Panduit Corp. v. Dennison Mfg. Co., 774 F.2d 1082, establish abandonment); but see Davis Harvester 1101, 227 USPQ 337, 350 (Fed. Cir. 1985). Co., Inc. v. Long Mfg. Co., 252 F. Supp. 989, Abandonment, suppression and concealment are 1009-10, 149 USPQ 420, 435-436 (E.D. N.C. 1966) treated by the courts under pre-AIA 35 U.S.C. (Where the inventor does nothing over a period of 102(g). See MPEP § 2138.03 for more information time to develop or patent his invention, ridicules the on this issue. attempts of another to develop that invention and begins to show active interest in promoting and 2135 Pre-AIA 35 U.S.C. 102(d) [R-11.2013] developing his invention only after successful marketing by another of a device embodying that [Editor Note: This MPEP section is not applicable invention, the inventor has abandoned his invention to applications subject to examination under the ®rst under pre-AIA 35 U.S.C. 102(c).). inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et III. DELAY IN REAPPLYING FOR PATENT seq. to determine whether an application is subject AFTER ABANDONMENT OF PREVIOUS PATENT to examination under the FITF provisions, and APPLICATION MPEP § 2150 et seq. for examination of applications subject to those provisions.] Where there is no evidence of expressed intent or conduct by inventor to abandon his invention, delay Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty in reapplying for patent after abandonment of a and loss of right to patent. previous application does not constitute abandonment under pre-AIA 35 U.S.C. 102(c). A person shall be entitled to a patent unless - Petersen v. Fee Int'l, Ltd., 381 F. Supp. 1071, 182 ***** USPQ 264 (W.D. Okla. 1974). (d) the invention was ®rst patented or caused to be patented, IV. DISCLOSURE WITHOUT CLAIMING IN A or was the subject of an inventor's certi®cate, by the applicant or his legal representatives or assigns in a foreign country prior PRIOR ISSUED PATENT to the date of the application for patent in this country on an application for patent or inventor's certi®cate ®led more than Any inference of abandonment (i.e., intent to twelve months before the ®ling of the application in the United dedicate to the public) of subject matter disclosed States. but not claimed in a previously issued patent is ***** rebuttable by an application ®led at any time before GENERAL REQUIREMENTS OF 35 U.S.C. 102(d) a statutory bar arises. Accordingly, a rejection of a claim of a patent application under pre-AIA Pre-AIA 35 U.S.C. 102(d) establishes four conditions 35 U.S.C. 102(c) predicated solely on the issuance which, if all are present, establish a bar against the of a patent which discloses the subject matter of the granting of a patent in this country: claim in the application without claiming it would be improper, regardless of whether there is (A) The foreign application must be ®led more copendency between the application at issue and the than 12 months before the effective U.S. ®ling date application which issued as the patent. In re Gibbs, (See MPEP § 706.02 regarding effective U.S. ®ling 437 F.2d 486, 168 USPQ 578 (CCPA 1971). date of an application);

V. ONLY WHEN THERE IS A PRIORITY (B) The foreign application must have been ®led CONTEST CAN A LAPSE OF TIME BAR A by the same applicant as in the United States or by PATENT his or her legal representatives or assigns. (C) The foreign patent or inventor's certi®cate The mere lapse of time will not bar a patent. The must be actually granted (e.g., by sealing of the only exception is when there is a priority contest papers in Great Britain) before the U.S. ®ling date. It need not be published.

Rev. 07.2015, October 2015 2100-98 PATENTABILITY § 2135.01

(D) The same invention must be involved. B. A Continuation-in-Part Breaks the Chain of Priority as to Foreign as Well as U.S. Parents If such a foreign patent or inventor's certi®cate is discovered by the examiner, the rejection is made In the case where applicant ®les a foreign under pre-AIA 35 U.S.C. 102(d) on the ground of application, later ®les a U.S. application claiming statutory bar. See MPEP § 2135.01 for further priority based on the foreign application, and then clari®cation of each of the four requirements of ®les a continuation-in-part (CIP) application whose pre-AIA 35 U.S.C. 102(d). claims are not entitled to the ®ling date of the U.S. parent, the effective ®ling date is the ®ling date of 2135.01 The Four Requirements of Pre-AIA the CIP and applicant cannot obtain the bene®t of 35 U.S.C. 102(d) [R-11.2013] either the U.S. parent or foreign application ®ling dates. In re Van Langenhoven, 458 F.2d 132, 137, [Editor Note: This MPEP section is not applicable 173 USPQ 426, 429 (CCPA 1972). If the foreign to applications subject to examination under the ®rst application issues into a patent before the ®ling date inventor to ®le (FITF) provisions of the AIA as set of the CIP, it may be used in a pre-AIA 35 U.S.C. forth in 35 U.S.C. 100 (note). See MPEP § 2159 et 102(d)/103 rejection if the subject matter added to seq. to determine whether an application is subject the CIP does not render the claims nonobvious over to examination under the FITF provisions, and the foreign patent. Ex parte Appeal No. 242-47, 196 MPEP § 2150 et seq. for examination of applications USPQ 828 (Bd. App. 1976) (Foreign patent can be subject to those provisions.] combined with other prior art to bar a U.S. patent in an obviousness rejection based on pre-AIA 35 U.S.C. I. FOREIGN APPLICATION MUST BE FILED 102(d)/103). MORE THAN 12 MONTHS BEFORE THE EFFECTIVE U.S. FILING DATE II. FOREIGN APPLICATION MUST HAVE BEEN FILED BY SAME APPLICANT, HIS OR HER A. An Anniversary Date Ending on a Weekend or LEGAL REPRESENTATIVE OR ASSIGNS Holiday Results in an Extension to the Next Business Day Note that where the U.S. application was made by two or more inventors, it is permissible for these The U.S. application is ®led in time to prevent a inventors to claim priority from separate pre-AIA 35 U.S.C. 102(d) bar from arising if it is applications, each to one of the inventors or a ®led on the 1 year anniversary date of the ®ling date subcombination of inventors. For instance, a U.S. of the foreign application. If this day is a Saturday, application naming inventors A and B may be Sunday or federal holiday, the year would be entitled to priority from one application to A and extended to the following business day. See Ex parte one to B ®led in a foreign country. Olah, 131 USPQ 41 (Bd. App. 1960). Despite changes to 37 CFR 1.6(a)(2) and 37 CFR 1.10, which III. THE FOREIGN PATENT OR INVENTOR'S require the PTO to accord a ®ling date to an CERTIFICATE WAS ACTUALLY GRANTED application as of the date of deposit as Priority BEFORE THE U.S. FILING DATE Express Mail® with the U.S. Postal Service in accordance with 37 CFR 1.10 (e.g., a Saturday ®ling A. To Be ªPatentedº an Exclusionary Right Must Be date), the rule changes do not affect applicant's Awarded to the Applicant concurrent right to defer the ®ling of an application until the next business day when the last day for ªPatentedº means ªa formal bestowal of patent rights ªtaking any actionº falls on a Saturday, Sunday, or from the sovereign to the applicant.º In re Monks, a federal holiday (e.g., the last day of the 1-year 588 F.2d 308, 310, 200 USPQ 129, 131 (CCPA grace period falls on a Saturday). 1978); American Infra-Red Radiant Co. v. Lambert Indus., 360 F.2d 977, 149 USPQ 722 (8th Cir.), cert. denied, 385 U.S. 920 (1966) (German Gebrauchsmuster petty patent was held to be a patent usable in a pre-AIA 35 U.S.C. 102(d) rejection.

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Gebrauchmustern are not examined and only grant for purposes of rejection under pre-AIA 35 U.S.C. a 6-year patent term. However, except as to duration, 102(d).). the exclusionary patent right granted is as extensive as in the U.S.). D. Grant Occurs When Patent Becomes Enforceable

B. A Published Application Is Not a ªPatentº The critical date of a foreign patent as a reference under pre-AIA 35 U.S.C. 102(d) is the date the An application must issue into a patent before it can patent becomes enforceable (issued, sealed or be applied in a pre-AIA 35 U.S.C. 102(d) rejection. granted). In re Monks, 588 F.2d 308, 310, 200 Ex parte Fujishiro, 199 USPQ 36 (Bd. App. 1977) USPQ 129, 131 (CCPA 1978) (British reference (ªPatenting,º within the meaning of pre-AIA 35 became available as prior art on date the patent was U.S.C. 102(d), does not occur upon laying open of ªsealedº because as of this date applicant had the a Japanese utility model application (kokai or right to exclude others from making, using or selling kohyo)); Ex parte Links, 184 USPQ 429 (Bd. App. the claimed invention.). 1974) (German applications, which have not yet been published for opposition, are published in the E. Pre-AIA 35 U.S.C. 102(d) Applies as of Grant Date form of printed documents called Even If There Is a Period of Secrecy After Patent Grant Offenlegungsschriften 18 months after ®ling. These applications are unexamined or in the process of A period of secrecy after granting the patent, as in being examined at the time of publication. The Board Belgium and Spain, has been held to have no effect held that an Offenlegungsschrift is not a patent under in connection with pre-AIA 35 U.S.C. 102(d). These pre-AIA 35 U.S.C. 102(d) even though some patents are usable in rejections under pre-AIA 35 provisional rights are granted. The Board explained U.S.C. 102(d) as of the date patent rights are granted. that the provisional rights are minimal and do not In re Kathawala, 9 F.3d 942, 28 USPQ2d 1789 come into force if the application is withdrawn or (Fed. Cir. 1993) (An invention is ªpatentedº for refused.). purposes of pre-AIA 35 U.S.C. 102(d) when the patentee's rights under the patent become ®xed. The C. An Allowed Application Can Be a ªPatentº for fact that applicant's Spanish application was not Purposes of Pre-AIA 35 U.S.C. 102(d) as of the Date published until after the U.S. ®ling date is immaterial Published for Opposition Even Though It Has Not Yet since the Spanish patent was granted before U.S. Been Granted as a Patent ®ling.); Gramme Elec. Co. v. Arnoux and Hochhausen Elec. Co., 17 F. 838, 1883 C.D. 418 An examined application which has been allowed (S.D.N.Y. 1883) (Rejection made under a by the examiner and published to allow the public predecessor of pre-AIA 35 U.S.C. 102(d) based on to oppose the grant of a patent has been held to be an Austrian patent granted an exclusionary right for a ªpatentº for purposes of rejection under pre-AIA 1 year but was kept secret, at the option of the 35 U.S.C. 102(d) as of the date of publication for patentee, for that period. The court held that the opposition if substantial provisional enforcement Austrian patent grant date was the relevant date rights arise. Ex parte Beik, 161 USPQ 795 (Bd. App. under the statute for purposes of pre-AIA 35 U.S.C. 1968) (This case dealt with examined German 102(d) but that the patent could not have been used applications. After a determination that an to in a rejection under pre-AIA 35 U.S.C. 102(a) or application is allowable, the application is published (b).); In re Talbott, 443 F.2d 1397, 170 USPQ 281 in the form of a printed document called an (CCPA 1971) (Applicant cannot avoid a pre-AIA Auslegeschrift. The publication begins a period of 35 U.S.C. 102(d) rejection by exercising an option opposition were the public can present evidence to keep the subject matter of a German showing unpatentability. Provisional patent rights Gebrauchsmuster (petty patent) in secrecy until time are granted which are substantially the same as those of U.S. ®ling.). available once the opposition period is over and the patent is granted. The Board found that an Auslegeschrift provides the legal effect of a patent

Rev. 07.2015, October 2015 2100-100 PATENTABILITY § 2136

IV. THE SAME INVENTION MUST BE INVOLVED and MPEP § 2150 et seq. for examination of applications subject to those provisions.] ªSame Inventionº Means That the Application Claims Could Have Been Presented in the Foreign Patent Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent.

Under pre-AIA 35 U.S.C. 102(d), the ªinvention... A person shall be entitled to a patent unless- patentedº in the foreign country must be the same as the invention sought to be patented in the U.S. ***** When the foreign patent contains the same claims as the U.S. application, there is no question that ªthe (e) the invention was described in Ð (1) an application for patent, published under section 122(b), by another ®led in the invention was ®rst patented... in a foreign country.º United States before the invention by the applicant for patent In re Kathawala, 9 F.3d 942, 945, 28 USPQ2d 1785, or (2) a patent granted on an application for patent by another 1787 (Fed. Cir. 1993). However, the claims need ®led in the United States before the invention by the applicant not be identical or even within the same statutory for patent, except that an international application ®led under the treaty de®ned in section 351(a) shall have the effects for the class. If applicant is granted a foreign patent which purposes of this subsection of an application ®led in the United fully discloses the invention and which gives States only if the international application designated the United applicant a number of different claiming options in States and was published under Article 21(2) of such treaty in the U.S., the reference in pre-AIA 35 U.S.C. 102(d) the English language. to ª`invention... patented' necessarily includes all ***** the disclosed aspects of the invention. Thus, the Pre-AIA 35 U.S.C. 102(e) allows the use of certain [pre-AIA] section 102(d) bar applies regardless international application publications and U.S. patent whether the foreign patent contains claims to less application publications, and certain U.S. patents as than all aspects of the invention.º 9 F.3d at 946, prior art under pre-AIA 35 U.S.C. 102(e) as of their 28 USPQ2d at 1788. In essence, a pre-AIA 35 U.S.C. respective U.S. ®ling dates, including certain 102(d) rejection applies if applicant's foreign international ®ling dates. The prior art date of a application supports the subject matter of the U.S. reference under pre-AIA 35 U.S.C. 102(e) may be claims. Id. at 944, 947, 28 USPQ2d at 1786, 1789 the international ®ling date if the international ®ling (Applicant was granted a Spanish patent claiming a date was on or after November 29, 2000, the method of making a composition. The patent international application designated the United disclosed compounds, methods of use and processes States, and the international application was of making the compounds. After the Spanish patent published by the World Intellectual Property was granted, the applicant ®led a U.S. application Organization (WIPO) under the Patent Cooperation with claims directed to the compound but not the Treaty (PCT) Article 21(2) in the English language. process of making it. The Federal Circuit held that See MPEP § 706.02(f)(1) for examination guidelines it did not matter that the claims in the U.S. on the application of pre-AIA 35 U.S.C. 102(e). application were directed to the composition instead References based on international applications that of the process because the foreign speci®cation were ®led prior to November 29, 2000 are subject would have supported claims to the composition. It to the pre-AIPA version of 35 U.S.C. 102(e) (i.e., was immaterial that the formulations were the version in force on November 28, 2000). See unpatentable pharmaceutical compositions in Spain.). MPEP § 2136.03 for additional information.

2136 Pre-AIA 35 U.S.C. 102(e) [R-11.2013] I. STATUTORY INVENTION REGISTRATIONS (SIRs) ARE ELIGIBLE AS PRIOR ART UNDER 35 [Editor Note: This MPEP section is not applicable U.S.C. 102 and Pre-AIA 35 U.S.C. 102(e) to applications subject to examination under the ®rst inventor to ®le (FITF) provisions of the AIA as set In accordance with former 35 U.S.C. 157(c), a forth in 35 U.S.C. 100 (note), except for determining published SIR will be treated the same as a U.S. eligibility of SIRs as eligible prior art. See MPEP § patent for all defensive purposes, usable as a 2159 et seq. to determine whether an application is reference as of its ®ling date in the same manner as subject to examination under the FITF provisions, a U.S. patent. A SIR is prior art under all applicable

2100-101 Rev. 07.2015, October 2015 § 2136.01 MANUAL OF PATENT EXAMINING PROCEDURE

sections of 35 U.S.C. 102 including pre-AIA 35 publication), it is permissible to provisionally reject U.S.C. 102(e). See MPEP § 1111. a later application over an earlier ®led, and unpublished, application under pre-AIA 35 U.S.C. II. DEFENSIVE PUBLICATIONS ARE NOT PRIOR 102(e) when there is a common assignee or inventor. ART AS OF THEIR FILING DATE In re Irish, 433 F.2d 1342, 167 USPQ 764 (CCPA 1970). In addition, a provisional pre-AIA 35 U.S.C. The Defensive Publication Program, available 102(e) rejection may be made if the earlier ®led between April 1968 and May 1985, provided for the copending U.S. application has been published as voluntary publication of the abstract of the technical redacted (37 CFR 1.217) and the subject matter disclosure of a pending application under certain relied upon in the rejection is not supported in the conditions. A defensive publication is not a patent redacted publication of the patent application. Such or an application publication under 35 U.S.C. 122(b); a provisional rejection ªserves to put applicant on it is a publication. Therefore, it is prior art only as notice at the earliest possible time of the possible of its publication date. Ex parte Osmond, 191 USPQ prior art relationship between copending 334 (Bd. App. 1973). See MPEP § 711.06(a) for applicationsº and gives applicant the fullest more information on Defensive Publications. opportunity to overcome the rejection by amendment or submission of evidence. In addition, since both 2136.01 Status of U.S. Application as a applications are pending and usually have the same Reference [R-11.2013] assignee, more options are available to applicant for overcoming the provisional rejection than if the other [Editor Note: This MPEP section is not applicable application were already issued. Ex parte Bartfeld, to applications subject to examination under the ®rst 16 USPQ2d 1714 (Bd. Pat. App. & Int. 1990) aff'd inventor to ®le (FITF) provisions of the AIA as set on other grounds, 925 F.2d 1450, 17 USPQ2d 1885 forth in 35 U.S.C. 100 (note). See MPEP § 2159 et (Fed. Cir. 1991). Note that provisional rejections seq. to determine whether an application is subject over pre-AIA 35 U.S.C. 102(e) are only authorized to examination under the FITF provisions, and when there is a common inventor or assignee, MPEP § 2150 et seq. for examination of applications otherwise the copending application prior to subject to those provisions.] publication must remain con®dential. MPEP § 706.02(f)(2) and MPEP § 706.02(k) discuss the I. WHEN THERE IS NO COMMON ASSIGNEE OR procedures to be used in provisional rejections over INVENTOR, A U.S. APPLICATION MUST ISSUE pre-AIA 35 U.S.C. 102(e) and pre-AIA 35 U.S.C. AS A PATENT OR BE PUBLISHED AS A SIR OR 102(e)/103. AS AN APPLICATION PUBLICATION BEFORE IT IS AVAILABLE AS PRIOR ART UNDER Pre-AIA For applications ®led on or after November 29, 1999 35 U.S.C. 102(e) or pending on or after December 10, 2004, a provisional rejection under 35 U.S.C. 103(a) using In addition to U.S. patents and SIRs, certain U.S. prior art under pre-AIA 35 U.S.C. 102(e) is not application publications and certain international proper if the application contains evidence that the application publications are also available as prior application and the prior art reference were owned art under pre-AIA 35 U.S.C. 102(e) as of their by the same person, or subject to an obligation of effective U.S. ®ling dates (which will include certain assignment to the same person, at the time the international ®ling dates). See MPEP § 706.02(a). invention was made. The changes to pre-AIA 35 U.S.C. 102(e) in the Intellectual Property and High II. WHEN THERE IS A COMMON ASSIGNEE OR Technology Technical Amendments Act of 2002 INVENTOR, A PROVISIONAL Pre-AIA 35 U.S.C. (Pub. L. 107-273, 116 Stat. 1758 (2002)) did not 102(e) REJECTION OVER AN EARLIER FILED affect 35 U.S.C. 103(c) as amended on November UNPUBLISHED APPLICATION CAN BE MADE 29, 1999. See MPEP § 706.02(l)(1) through § 706.02(l)(3) for information relating to rejections Based on the assumption that an application will under pre-AIA 35 U.S.C. 103 and evidence of ripen into a U.S. patent (or into an application common ownership.

Rev. 07.2015, October 2015 2100-102 PATENTABILITY § 2136.02

In addition, certain non-commonly owned references publication having an earlier effective U.S. ®ling may be disquali®ed from being applied in a rejection date (which will include certain international ®ling under pre-AIA 35 U.S.C. 103(a) due to the dates) can be relied on to reject the claims. Sun Cooperative Research and Technology Enhancement Studs, Inc. v. ATA Equip. Leasing, Inc., 872 F.2d Act of 2004 (CREATE Act) (Pub. L. 108-453; 118 978, 983, 10 USPQ2d 1338, 1342 (Fed. Cir. 1989). Stat. 3596 (2004)), which was enacted on December See MPEP § 706.02(a). 10, 2004 and was effective for all patents granted on or after December 10, 2004. The CREATE Act II. REFERENCE MUST ITSELF CONTAIN THE amended pre-AIA 35 U.S.C. 103(c) to provide that SUBJECT MATTER RELIED ON IN THE subject matter developed by another person shall be REJECTION treated as owned by the same person or subject to an obligation of assignment to the same person for When a U.S. patent, a U.S. patent application purposes of determining obviousness if certain publication, or an international application conditions are met. Pre-AIA 35 U.S.C.103(c), as publication is used to reject claims under pre-AIA amended by the CREATE Act, continues to apply 35 U.S.C. 102(e), the disclosure relied on in the only to subject matter which quali®es as prior art rejection must be present in the issued patent or under pre-AIA 35 U.S.C. 102(e), (f) or (g), and application publication. It is the earliest effective which is being relied upon in a rejection under 35 U.S. ®ling date (which will include certain U.S.C. 103. It does not apply to or affect subject international ®ling dates) of the U.S. patent or matter which is applied in a rejection under pre-AIA application publication being relied on as the critical 35 U.S.C. 102 or a double patenting rejection (see reference date and subject matter not included in the 37 CFR 1.78(c) and MPEP § 804). In addition, if patent or application publication itself can only be the subject matter quali®es as prior art under any used when that subject matter becomes public. other subsection of pre-AIA 35 U.S.C. 102 (e.g., Portions of the patent application which were pre-AIA 35 U.S.C. 102(a) or (b)) it will not be canceled are not part of the patent or application disquali®ed as prior art under pre-AIA 35 U.S.C. publication and thus cannot be relied on in a pre-AIA 103(c). See also MPEP § 706.02(l)(1) through § 35 U.S.C. 102(e) rejection over the issued patent or 706.02(l)(3) for information relating to rejections application publication. Ex parte Stalego, 154 USPQ under pre-AIA 35 U.S.C. 103 and evidence of joint 52 (Bd. App. 1966). Likewise, subject matter which research agreements. is disclosed in a parent application, but not included in the child continuation-in-part (CIP) cannot be 2136.02 Content of the Prior Art Available relied on in a pre-AIA 35 U.S.C. 102(e) rejection Against the Claims [R-11.2013] over the issued or published CIP. In re Lund, 376 F.2d 982, 153 USPQ 625 (CCPA 1967) (The examiner made a pre-AIA 35 U.S.C. 102(e) rejection Editor Note: This MPEP section is not applicable over an issued U.S. patent which was a to applications subject to examination under the ®rst continuation-in-part (CIP). The parent application inventor to ®le (FITF) provisions of the AIA as set of the U.S. patent reference contained an example forth in 35 U.S.C. 100 (note). See MPEP § 2159 et II which was not carried over to the CIP. The court seq. to determine whether an application is subject held that the subject matter embodied in the canceled to examination under the FITF provisions, and example II could not be relied on as of either parent MPEP § 2150 et seq. for examination of applications or child ®ling date. Thus, the use of example II subject to those provisions.] subject matter to reject the claims under pre-AIA 35 U.S.C. 102(e) was improper.). I. A 35 U.S.C. 102(e) REJECTION MAY RELY ON ANY PART OF THE PATENT OR APPLICATION PUBLICATION DISCLOSURE

Under pre-AIA 35 U.S.C. 102(e), the entire disclosure of a U.S. patent, a U.S. patent application publication, or an international application

2100-103 Rev. 07.2015, October 2015 § 2136.03 MANUAL OF PATENT EXAMINING PROCEDURE

III. THE SUPREME COURT HAS AUTHORIZED priority date of the reference under 35 U.S.C. 35 U.S.C. 103 REJECTIONS BASED ON PRE-AIA 119(a)-(d), (f), and 35 U.S.C. 365(a) cannot be used 35 U.S.C. 102(e) to antedate the application ®ling date. In contrast, applicant may be able to overcome the pre-AIA 35 U.S. patents may be used as of their ®ling dates to U.S.C. 102(e) rejection by proving he or she is show that the claimed subject matter is anticipated entitled to his or her own 35 U.S.C. 119 priority date or obvious. Obviousness can be shown by combining which is earlier than the reference's U.S. ®ling date. other prior art with the U.S. patent reference in a In re Hilmer, 359 F.2d 859, 149 USPQ 480 (CCPA 35 U.S.C. 103 rejection. Hazeltine Research v. 1966) (Hilmer I) (Applicant ®led an application Brenner, 382 U.S. 252, 147 USPQ 429 (1965). with a right of priority to a German application. The Similarly, certain U.S. application publications and examiner rejected the claims over a U.S. patent to certain international application publications may Habicht based on its Swiss priority date. The U.S. also be used as of their earliest effective U.S. ®ling ®ling date of Habicht was later than the application's dates (which will include certain international ®ling German priority date. The court held that the dates) to show that the claimed subject matter would reference's Swiss priority date could not be relied have been anticipated or obvious. on in a pre-AIA 35 U.S.C. 102(e) rejection. Because the U.S. ®ling date of Habicht was later than the See MPEP § 706.02(1)(1) through § 706.02(l)(3) for earliest effective ®ling date (German priority date) additional information on rejections under 35 U.S.C. of the application, the rejection was reversed.). See 103 and evidence of common ownership or a joint MPEP § 216 for information on procedures to be research agreement. followed in considering applicant©s right of priority.

2136.03 Critical Reference Date [R-11.2013] Note that certain international application (PCT) ®lings are considered to be ª®lings in the United [Editor Note: This MPEP section is not applicable Statesº for purposes of applying an application to applications subject to examination under the ®rst publication as prior art. See MPEP § 706.02(a). inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et II. INTERNATIONAL (PCT) APPLICATIONS; seq. to determine whether an application is subject INTERNATIONAL APPLICATION to examination under the FITF provisions, and PUBLICATIONS MPEP § 2150 et seq. for examination of applications subject to those provisions.] A. International Application Filed On or After November 29, 2000 I. FOREIGN PRIORITY DATE If the potential reference resulted from, or claimed Reference's Foreign Priority Date Under 35 U.S.C. the bene®t of, an international application, the 119(a)-(d) and (f) Cannot Be Used as the Pre-AIA 35 following must be determined: U.S.C. 102(e) Reference Date (A) If the international application meets the Pre-AIA 35 U.S.C. 102(e) is explicitly limited to following three conditions: certain references ª®led in the United States before (1) an international ®ling date on or after the invention thereof by the applicantº (emphasis November 29, 2000; added). Foreign applications' ®ling dates that are (2) designated the United States; and claimed (via 35 U.S.C. 119(a)±(d), (f) or 35 U.S.C. 365(a)) in applications, which have been published (3) published under PCT Article 21(2) in as U.S. or WIPO application publications or patented English, in the U.S., may not be used as pre-AIA 35 U.S.C. 102(e) dates for prior art purposes. This includes the international ®ling date is a U.S. ®ling date for international ®ling dates claimed as foreign priority prior art purposes under pre-AIA 35 U.S.C. 102(e). dates under 35 U.S.C. 365(a).Therefore, the foreign If such an international application properly claims bene®t to an earlier-®led U.S. or international

Rev. 07.2015, October 2015 2100-104 PATENTABILITY § 2136.03

application, or priority to an earlier-®led U.S. provisional application, apply the reference under the invention thereof by the applicant for patent, or on an international application by another who has ful®lled the pre-AIA 35 U.S.C. 102(e) as of the earlier ®ling requirements of paragraphs (1), (2), and (4) of section 371(c) date, assuming all the conditions of pre-AIA 35 of this title before the invention thereof by the applicant for U.S.C. 102(e) and 35 U.S.C. 119(e), 120, or 365(c) patent. are met. In addition, the subject matter relied upon ***** in the rejection must be disclosed in the earlier-®led If an international application has an international application in compliance with 35 U.S.C. 112(a) ®ling date prior to November 29, 2000, the reference /pre-AIA 35 U.S.C. 112, ®rst paragraph, in order to should be applied under the provisions of 35 U.S.C. give that subject matter the bene®t of the earlier 102 and 374 as in force on November 28, 2000 (prior ®ling date under pre-AIA 35 U.S.C. 102(e). Note, to the AIPA amendments): where the earlier application is an international application, the earlier international application must (1) For U.S. patents, apply the reference under satisfy the same three conditions (i.e., ®led on or 35 U.S.C. 102(e) as in force on November 28, 2000 after November 29, 2000, designated the U.S., and as of the earlier of the date of completion of the had been published in English under PCT Article requirements of 35 U.S.C. 371(c)(1), (2) and (4) or 21(2)) for the earlier international ®ling date to be the ®ling date of the later-®led U.S. application that a U.S. ®ling date for prior art purposes under claimed the bene®t of the international application; pre-AIA 35 U.S.C.102(e). (2) For U.S. application publications and WIPO (B) If the international application was ®led on publications directly resulting from international or after November 29, 2000, but did not designate applications under PCT Article 21(2), never apply the United States or was not published in English these references under 35 U.S.C. 102(e) as in force under PCT Article 21(2), do not treat the on November 28, 2000. These references may be international ®ling date as a U.S. ®ling date. In this applied as of their publication dates under pre-AIA situation, do not apply the reference as of its 35 U.S.C. 102(a) or (b); international ®ling date, its date of completion of the 35 U.S.C. 371(c)(1), (2) and (4) requirements, (3) For U.S. application publications of or any earlier ®ling date to which such an applications that claim the bene®t under 35 U.S.C. international application claims bene®t or priority. 120 or 365(c) of an international application ®led The reference may be applied under pre-AIA prior to November 29, 2000, apply the reference 35 U.S.C. 102(a) or (b) as of its publication date, or under 35 U.S.C. 102(e) as in force on November 28, pre-AIA 35 U.S.C. 102(e) as of any later U.S. ®ling 2000 as of the actual ®ling date of the later-®led date of an application that properly claimed the U.S. application that claimed the bene®t of the bene®t of the international application (if applicable). international application. B. International Application Filed Before November Examiners should be aware that although a 29, 2000 publication of, or a U.S. patent issued from, an international application may not be available as References based on international applications that prior art under former 35 U.S.C. 102(e) as in force were ®led prior to November 29, 2000 are subject on November 28, 2000 or under pre-AIA 35 U.S.C. to the pre-AIPA version of 35 U.S.C. 102(e) (i.e., 102(e), the corresponding WIPO publication of an the version in force on November 28, 2000) as set international application may have an earlier forth below. pre-AIA 35 U.S.C. 102(a) or (b) date.

Former 35 U.S.C. 102 Conditions for patentability; novelty III. PRIORITY FROM PROVISIONAL and loss of right to patent (as in force on November 28, 2000) APPLICATION UNDER 35 U.S.C. 119(e)

A person shall be entitled to a patent unless- The pre-AIA 35 U.S.C. 102(e) critical reference date ***** of a U.S. patent or U.S. application publications and certain international application publications entitled (e) the invention was described in a patent granted on an to the bene®t of the ®ling date of a provisional application for patent by another ®led in the United States before

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application under 35 U.S.C. 119(e) is the ®ling date variant, the reference is not prior art under pre-AIA of the provisional application with certain exceptions 35 U.S.C. 102(g). Furthermore, the reference does if the provisional application(s) properly supports not qualify as ªprior artº under 35 U.S.C. 102 as of the subject matter relied upon to make the rejection a date earlier than its ®ling date based upon any prior in compliance with 35 U.S.C 112(a)/ pre-AIA 35 inventive activity that is disclosed in the U.S. patent U.S.C. 112, ®rst paragraph. See MPEP § or U.S. patent application publication in the absence 706.02(f)(1), examples 5 to 9. Note that international of evidence that the subject matter was actually applications which (1) were ®led prior to November reduced to practice in this country on an earlier date. 29, 2000, or (2) did not designate the U.S., or (3) See MPEP § 2138. When the cases are not in were not published in English under PCT Article interference, the effective date of the reference as 21(2) by WIPO, may not be used to reach back prior art is its ®ling date in the United States (which (bridge) to an earlier ®ling date through a priority will include certain international ®ling dates), as or bene®t claim for prior art purposes under pre-AIA stated in pre-AIA 35 U.S.C. 102(e). See MPEP 35 U.S.C. 102(e). § 706.02(a). The date that the prior art subject matter was conceived or reduced to practice is of no IV. PARENT'S FILING DATE WHEN REFERENCE importance when pre-AIA 35 U.S.C. 102(g) is not IS A CONTINUATION-IN-PART OF THE PARENT at issue. Sun Studs, Inc. v. ATA Equip. Leasing, Inc., 872 F.2d 978, 983, 10 USPQ2d 1338, 1342 (Fed. Filing Date of U.S. Parent Application Can Only Be Cir. 1989) (The defendant sought to invalidate Used as the Pre-AIA 35 U.S.C. 102(e) Date If It Supports patents issued to Mason and Sohn assigned to Sun the Subject Matter Relied Upon in the Child Studs. The earliest of these patents issued in June 1973. A U.S. patent to Mouat was found which For prior art purposes, a U.S. patent or patent issued in March 1976 and which disclosed the application publication that claims the bene®t of an invention of Mason and Sohn. While the patent to earlier ®ling date under 35 U.S.C. 120 of a prior Mouat issued after the Mason and Sohn patents, it nonprovisional application would be accorded the was ®led 7 months earlier than the earliest of the earlier ®ling date as its prior art date under pre-AIA Mason and Sohn patents. Sun Studs submitted 35 U.S.C. 102(e), provided the earlier-®led af®davits showing conception in 1969 and diligence application properly supports the subject matter to the constructive reduction to practice and therefore relied upon in any rejection in compliance with 35 antedated the patent to Mouat. The defendant sought U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst to show that Mouat conceived the invention in 1966. paragraph. In other words, the subject matter used The court held that conception of the subject matter in the rejection must be disclosed in the earlier-®led of the reference only becomes an issue when the application in compliance with 35 U.S.C. 112(a) or claims of the con¯icting patents cover inventions pre-AIA 35 U.S.C. 112, ®rst paragraph, in order for which are the same or obvious over one another. that subject matter to be entitled to the earlier ®ling When pre-AIA 35 U.S.C. 102(e) applies but not date under pre-AIA 35 U.S.C. 102(e). pre-AIA 35 U.S.C. 102(g), the ®ling date of the prior art patent is the earliest date that can be used to reject See also MPEP § 706.02(f)(1), examples 2 and 5 to or invalidate claims.). 9. 2136.04 Different Inventive Entity; Meaning V. DATE OF CONCEPTION OR REDUCTION TO of ªBy Anotherº [R-11.2013] PRACTICE [Editor Note: This MPEP section is not applicable Pre-AIA 35 U.S.C. 102(e) Reference Date Is the Filing Date, Not Date of Inventor's Conception or Reduction to applications subject to examination under the ®rst to Practice inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et If a reference available under pre-AIA 35 U.S.C. seq. to determine whether an application is subject 102(e) discloses, but does not claim the subject to examination under the FITF provisions, and matter of the claims being examined or an obvious

Rev. 07.2015, October 2015 2100-106 PATENTABILITY § 2136.05

MPEP § 2150 et seq. for examination of applications for discussion of methods of overcoming pre-AIA subject to those provisions.] 35 U.S.C. 102(e) rejections.

I. IF THERE IS ANY DIFFERENCE IN THE 2136.05 Overcoming a Rejection Under INVENTIVE ENTITY, THE REFERENCE IS ªBY Pre-AIA 35 U.S.C. 102(e) [R-11.2013] ANOTHERº [Editor Note: This MPEP section is not applicable ªAnotherº means other than applicants, In re Land, to applications subject to examination under the ®rst 368 F.2d 866, 151 USPQ 621 (CCPA 1966), in other inventor to ®le (FITF) provisions of the AIA as set words, a different inventive entity. The inventive forth in 35 U.S.C. 100 (note). See MPEP § 2159 et entity is different if not all inventors are the same. seq. to determine whether an application is subject The fact that the application and reference have one to examination under the FITF provisions, and or more inventors in common is immaterial. Ex MPEP § 2150 et seq. for examination of applications parte DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. subject to those provisions.] & Inter. 1992) (The examiner made a pre-AIA 35 U.S.C. 102(e) rejection based on an issued U.S. patent to three inventors. The rejected application was a continuation-in-part of the issued parent with I. A PRE-AIA 35 U.S.C. 102(e) REJECTION CAN BE OVERCOME BY ANTEDATING THE FILING an extra inventor. The Board found that the patent DATE OR SHOWING THAT DISCLOSURE was ªby anotherº and thus could be used in a RELIED ON IS APPLICANT©S OWN WORK pre-AIA 35 U.S.C. 102(e)/103 rejection of the application.). When a prior U.S. patent, U.S. patent application publication, or international application publication II. A DIFFERENT INVENTIVE ENTITY IS PRIMA is not a statutory bar, a pre-AIA 35 U.S.C. 102(e) FACIE EVIDENCE THAT THE REFERENCE IS rejection can be overcome by antedating the ®ling ªBY ANOTHERº date (see MPEP § 2136.03 regarding critical reference date of pre-AIA 35 U.S.C. 102(e) prior As stated by the House and Senate reports on the art) of the reference by submitting an af®davit or bills enacting section pre-AIA 35 U.S.C. 102(e) as declaration under 37 CFR 1.131 or by submitting an part of the 1952 Patent Act, this subsection of 102 af®davit or declaration under 37 CFR 1.132 codi®es the Milburn rule of Milburn v. establishing that the relevant disclosure is applicant's Davis-Bournonville, 270 U.S. 390 (1926). The own work. In re Mathews, 408 F.2d 1393, 161 Milburn rule authorized the use of a U.S. patent USPQ 276 (CCPA 1969). The ®ling date can also containing a disclosure of the invention as a be antedated by applicant's earlier foreign priority reference against a later ®led application as of the application or provisional application if 35 U.S.C. U.S. patent ®ling date. The existence of an earlier 119 is met and the foreign application or provisional ®led U.S. application containing the subject matter application ªsupportsº (conforms to 35 U.S.C. 112(a) claimed in the application being examined indicates or pre-AIA 35 U.S.C. 112, ®rst paragraph, that applicant was not the ®rst inventor. Therefore, requirements) all the claims of the U.S. application. a U.S. patent, a U.S. patent application publication In re Gosteli,, 872 F.2d 1008, 10 USPQ2d 1614 or international application publication, by a different (Fed. Cir. 1989). But a prior application which was inventive entity, whether or not the application not copending with the application at issue cannot shares some inventors in common with the patent, be used to antedate a reference. In re Costello, 717 is prima facie evidence that the invention was made F.2d 1346, 219 USPQ 389 (Fed. Cir. 1983). A ªby anotherº as set forth in pre-AIA 35 U.S.C. terminal disclaimer also does not overcome a 102(e). In re Mathews, 408 F.2d 1393, 161 USPQ pre-AIA 35 U.S.C. 102(e) rejection. See, e.g., In re 276 (CCPA 1969); In re Facius, 408 F.2d 1396, Bartfeld, 925 F.2d 1415, 17 USPQ2d 1885 (Fed. 161 USPQ 294 (CCPA 1969); Ex parte Cir. 1991). DesOrmeaux, 25 USPQ2d 2040 (Bd. Pat. App. & Inter. 1992). See MPEP § 706.02(b) and § 2136.05

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See MPEP § 706.02(b) for a list of methods which described in the sole applicant's patent, or was can be used to overcome rejections based on pre-AIA thereafter described in the sole applicant's U.S. 35 U.S.C. 102(e) rejections. For information on the patent application publication or international required contents of a 37 CFR 1.131 af®davit or application publication, and then the joint application declaration and the situations in which such was ®led. In re Land, 368 F.2d 866, 151 USPQ 621 af®davits and declarations are permitted see MPEP (CCPA 1966). § 715. An af®davit or declaration is not appropriate if the reference describes applicant's own work. In In In re Land, separate U.S. patents to Rogers and this case, applicant must submit an af®davit or to Land were used to reject a joint application to declaration under 37 CFR 1.132. See the next Rogers and Land under pre-AIA 35 U.S.C. subsection for more information concerning the 102(e)/103. The inventors worked for the same requirements of 37 CFR 1.132 af®davits and company (Polaroid) and in the same laboratory. All declarations. the patents ¯owed from the same research. In addition, the patent applications were prepared by II. A PRE-AIA 35 U.S.C. 102(e) REJECTION CAN the same attorneys, were interrelated and contained BE OVERCOME BY SHOWING THE REFERENCE cross-references to each other. The court af®rmed IS DESCRIBING APPLICANT'S OWN WORK the rejection because (1) the inventive entities of the patents (one to Rogers and one to Land) were ªThe fact that an application has named a different different from the inventive entity of the joint inventive entity than a patent does not necessarily application (Rogers and Land) and (2) Land and make that patent prior art.º Applied Materials Inc. Rogers brought their knowledge of their individual v. Gemini Research Corp., 835 F.2d 279, 15 work with them when they made the joint invention. USPQ2d 1816 (Fed. Cir. 1988). The issue turns on There was no indication that the portions of the what the evidence of record shows as to who references relied on disclosed anything they did invented the subject matter. In re Whittle, 454 F.2d jointly. Neither was there any showing that what 1193, 1195, 172 USPQ 535, 537 (CCPA 1972). In they did jointly was done before the ®ling of the fact, even if applicant's work was publicly disclosed reference patent applications. prior to his or her application, applicant's own work may not be used against him or her in an application See also In re Carreira, 532 F.2d 1356, 189 USPQ subject to pre-AIA 35 U.S.C. 102 unless there is a 461 (CCPA 1976) (The examiner rejected claims to time bar under pre-AIA 35 U.S.C. 102(b). In re a joint application to Carreira, Kyrakakis, Solodar, DeBaun, 687 F.2d 459, 214 USPQ 933 (CCPA 1982) and Labana under pre-AIA 35 U.S.C. 102(e) and (citing In re Katz, 687 F.2d 450, 215 USPQ 14 103 in view of a U.S. patent issued to Tulagin and (CCPA 1982)). Therefore, when the unclaimed Carreira or a patent issued to Clark. The applicants subject matter of a reference is applicant's own submitted declarations under 37 CFR 1.132 by invention, applicant may overcome a prima facie Tulagin and Clark in which each declarant stated he case based on the patent, U.S. patent application was ªnot the inventor of the use of compounds publication, or international application publication, having a hydroxyl group in a position ortho to an by showing that the disclosure is a description of azo linkage.º The court held that these statements applicant's own previous work. Such a showing can were vague and inconclusive because the declarants be made by proving that the patentee, or the did not disclose the use of this generic compound inventor(s) of the U.S. patent application publication but rather species of this generic compound in their or the international application publication, was patents and it was the species which met the claims. associated with applicant (e.g. worked for the same The declaration that each did not invent the use of company) and learned of applicant's invention from the generic compound does not establish that Tulagin applicant. In re Mathews, 408 F.2d 1393, 161 USPQ and Clark did not invent the use of the species.) 276 (CCPA 1969). In the situation where one application is ®rst ®led by inventor X and then a MPEP § 715.01(a), § 715.01(c), and § 716.10 set later application is ®led by X & Y, it must be proven forth more information pertaining to the contents that the joint invention was made ®rst, was thereafter and uses of af®davits and declarations under 37 CFR

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1.132 for antedating references. See MPEP 687 F.2d 459, 214 USPQ 933 (CCPA 1982) (citing § 706.02(l)(1) for information pertaining to rejections In re Facius, 408 F.2d 1396, 1406, 161 USPQ 294, under pre-AIA 35 U.S.C. 102(e)/103 and the 301 (CCPA 1969)). applicability of pre-AIA 35 U.S.C. 103(c). See also In re Mathews, 408 F.2d 1393, 161 USPQ III. APPLICANT NEED NOT SHOW DILIGENCE 276 (CCPA 1969) (On September 15, 1961, Dewey OR REDUCTION TO PRACTICE WHEN THE ®led an application disclosing and claiming a time SUBJECT MATTER DISCLOSED IN THE delay protective device for an electric circuit. In REFERENCE IS APPLICANT'S OWN WORK disclosing the invention, Dewey completely described, but did not claim, a ªgating means 19º When the reference re¯ects applicant's own work, invented by Mathews which was usable in the applicant need not prove diligence or reduction to protective device. Dewey and Mathews were practice to establish that he or she invented the coworkers at General Electric Company, the subject matter disclosed in the reference. A showing assignee. Mathews ®led his application on March that the reference disclosure arose from applicant's 7, 1963, before the Dewey patent issued but almost work coupled with a showing of conception by the 18 months after its ®ling. The Mathews application applicant before the ®ling date of the reference will disclosed that ªone illustration of a circuit overcome the pre-AIA 35 U.S.C. 102(e) rejection. embodying the present invention is shown in The showing can be made by submission of an copending patent application S.N. 138,476-Dewey.º af®davit by the inventor under 37 CFR 1.132. The The examiner used Dewey to reject all the Mathews other patentees need not submit an af®davit claims under pre-AIA 35 U.S.C. 102(e). In response, disclaiming inventorship, but, if submitted, a Mathews submitted an af®davit by Dewey under disclaimer by all other patentees should be 37 CFR 1.132. In the af®davit, Dewey stated that considered by the examiner. In re DeBaun, 687 F.2d he did not invent the gating means 19 but had learned 459, 214 USPQ 933 (CCPA 1982) (Declaration of the gating means through Mathews and that GE submitted by DeBaun stated that he was the inventor attorneys had advised that the gating means be of subject matter disclosed in the U.S. patent disclosed in Dewey's application to comply with 35 reference of DeBaun and Noll. Exhibits were U.S.C. 112, ®rst paragraph. The examiner argued attached to the declaration showing conception and that the only way to overcome a pre-AIA 35 U.S.C. included drawings DeBaun had prepared and given 102(e) rejection was by submitting an af®davit or to counsel for purposes of preparing the application declaration under 37 CFR 1.131 to antedate the ®ling which issued as the reference patent. The court held date of the reference. The court reversed the that, even though the evidence was not suf®cient to rejection, holding that the totality of the evidence antedate the prior art patent under 37 CFR 1.131, on record showed that Dewey derived his knowledge diligence and/or reduction to practice was not from Mathews who is ªthe original, ®rst and sole required to show DeBaun invented the subject inventor.º). matter. Declarant's statement that he conceived the invention ®rst was enough to overcome the pre-AIA 2137 Pre-AIA 35 U.S.C. 102(f) [R-11.2013] 35 U.S.C. 102(e) rejection.). [Editor Note: This MPEP section is not applicable IV. CLAIMING OF INDIVIDUAL ELEMENTS OR SUBCOMBINATIONS IN A COMBINATION to applications subject to examination under the ®rst CLAIM OF THE REFERENCE DOES NOT ITSELF inventor to ®le (FITF) provisions of the AIA as set ESTABLISH THAT THE PATENTEE INVENTED forth in 35 U.S.C. 100 (note). See MPEP § 2159 et THOSE ELEMENTS seq. to determine whether an application is subject to examination under the FITF provisions, and The existence of combination claims in a reference MPEP § 2150 et seq. for examination of applications is not evidence that the patentee invented the subject to those provisions. For information individual elements or subcombinations included if pertaining to derivation proceedings see 37 CFR the elements and subcombinations are not separately 42.401.] claimed apart from the combination. In re DeBaun,

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Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. inquiry regarding the appropriate inventorship under pre-AIA subsection (f), or to rebut a rejection under A person shall be entitled to a patent unless - pre-AIA 35 U.S.C. 102(a) or (e), to provide a satisfactory showing by way of af®davit under 37 ***** CFR 1.132 that the inventorship of the application is correct in that the reference discloses subject (f) he did not himself invent the subject matter sought to be patented. matter invented by the applicant rather than derived ***** from the author or patentee notwithstanding the authorship of the article or the inventorship of the Where it can be shown that an applicant ªderivedº patent. In re Katz, 687 F.2d 450, 455, 215 USPQ an invention from another, a rejection under pre-AIA 14, 18 (CCPA 1982) (inquiry is appropriate to clarify 35 U.S.C. 102(f) is proper. Ex parte Kusko, 215 any ambiguity created by an article regarding USPQ 972, 974 (Bd. App. 1981) (ªmost, if not all, inventorship, and it is then incumbent upon the determinations under section 102(f) involve the applicant to provide ªa satisfactory showing that question of whether one party derived an invention would lead to a reasonable conclusion that from anotherº). [applicant] is the¼inventorº of the subject matter disclosed in the article and claimed in the While derivation will bar the issuance of a patent to application). the deriver, a disclosure by the deriver, absent a bar under pre-AIA 35 U.S.C. 102(b), will not bar the I. DERIVATION REQUIRES COMPLETE issuance of a patent to the party from which the CONCEPTION BY ANOTHER AND subject matter was derived. In re Costello, 717 F.2d COMMUNICATION TO THE ALLEGED DERIVER 1346, 1349, 219 USPQ 389, 390-91 (Fed. Cir. 1983) (ª[a] prior art reference that is not a statutory bar ªThe mere fact that a claim recites the use of various may be overcome [in an application subject to components, each of which can be argumentatively pre-AIA 35 U.S.C. 102] by two generally recognized assumed to be old, does not provide a proper basis methodsº: an af®davit under 37 CFR 1.131, or an for a rejection under pre-AIA 35 U.S.C. 102(f).º Ex af®davit under 37 CFR 1.132 ªshowing that the parte Billottet, 192 USPQ 413, 415 (Bd. App. 1976). relevant disclosure is a description of the applicant's Derivation requires complete conception by another own workº); In re Facius, 408 F.2d 1396, 1407, and communication of that conception by any means 161 USPQ 294, 302 (CCPA 1969) (subject matter to the party charged with derivation prior to any date incorporated into a patent that was brought to the on which it can be shown that the one charged with attention of the patentee by applicant, and hence derivation possessed knowledge of the invention. derived by the patentee from the applicant, is Kilbey v. Thiele, 199 USPQ 290, 294 (Bd. Pat. Inter. available for use against applicant unless applicant 1978). had actually invented the subject matter placed in the patent). See also Price v. Symsek, 988 F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir. 1993); Hedgewick Where there is a published article identifying the v. Akers, 497 F.2d 905, 908, 182 USPQ 167, 169 authorship (MPEP § 715.01(c)) or a patent (CCPA 1974). ªCommunication of a complete identifying the inventorship (MPEP § 715.01(a)) conception must be suf®cient to enable one of that discloses subject matter being claimed in an ordinary skill in the art to construct and successfully application undergoing examination, the designation operate the invention.º Hedgewick, 497 F.2d at 908, of authorship or inventorship does not raise a 182 USPQ at 169. See also Gambro Lundia AB v. presumption of inventorship with respect to the Baxter Healthcare Corp., 110 F.3d 1573, 1577, 42 subject matter disclosed in the article or with respect USPQ2d 1378, 1383 (Fed. Cir. 1997) (Issue in to the subject matter disclosed but not claimed in proving derivation is ªwhether the communication the patent so as to justify a rejection under pre-AIA enabled one of ordinary skill in the art to make the 35 U.S.C. 102(f). However, it is incumbent upon the patented invention.º). inventors named in the application, in reply to an

Rev. 07.2015, October 2015 2100-110 PATENTABILITY § 2137.01

II. PARTY ALLEGING DERIVATION DOES NOT a declaration by the applicant that he is the sole HAVE TO PROVE AN ACTUAL REDUCTION TO inventor.). PRACTICE, DERIVATION OF PUBLIC KNOWLEDGE, OR DERIVATION IN THIS 2137.01 Inventorship [R-07.2015] COUNTRY

The party alleging derivation ªneed not prove an The requirement that the applicant for a patent in an actual reduction to practice in order to show application ®led before September 16, 2012 be the derivation.º Scott v. Brandenburger, 216 USPQ inventor(s) (except as otherwise provided in pre-AIA 326, 327 (Bd. App. 1982). Furthermore, the 37 CFR 1.41), and that the inventor or each joint application of subsection (f) is not limited to public inventor be identi®ed in applications ®led on or after knowledge derived from another, and ªthe site of September 16, 2012, are characteristics of U.S. derivation need not be in this country to bar a deriver patent law not generally shared by other countries. from patenting the subject matter.º Ex parte Consequently, foreign applicants may misunderstand Andresen, 212 USPQ 100, 102 (Bd. App. 1981). U.S. law regarding naming of the actual inventors causing an error in the inventorship of a U.S. III. DERIVATION DISTINGUISHED FROM application that may claim priority to a previous PRIORITY OF INVENTION foreign application under 35 U.S.C. 119. A request under 37 CFR 1.48 is required to correct any error Although derivation and priority of invention both in naming the inventors in the U.S. application as focus on inventorship, derivation addresses ®led. See MPEP § 602.01(c) et seq. Foreign originality (i.e., who invented the subject matter), applicants may need to be reminded of the whereas priority focuses on which party ®rst requirement for the same inventor or at least one invented the subject matter. Price v. Symsek, 988 common joint inventor between a U.S. application F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir. and a 35 U.S.C. 119 priority application. See MPEP 1993). § 213.02, subsection II.

IV. PRE-AIA 35 U.S.C. 102(f) MAY APPLY WHERE If a determination is made that the inventive entity Pre-AIA 35 U.S.C. 102(a) AND PRE-AIA 35 U.S.C. named in a U.S. application is not correct, such as 102(e) ARE NOT AVAILABLE STATUTORY when a request under 37 CFR 1.48(a) is not granted GROUNDS FOR REJECTION or is not entered for technical reasons, but the admission therein regarding the error in inventorship Pre-AIA 35 U.S.C. 102(f) does not require an inquiry is uncontroverted, a rejection should be made on this into the relative dates of a reference and the basis. See MPEP § 706.03(a), subsection IV, for application, and therefore may be applicable where rejections under 35 U.S.C. 101 and 35 U.S.C. 115 pre-AIA subsections (a) and (e) are not available for (and pre-AIA 35 U.S.C. 102(f) for applications references having an effective date subsequent to subject to pre-AIA 35 U.S.C. 102) for failure to set the effective date of the application being examined. forth the correct inventorship. However for a reference having a date later than the date of the application some evidence may exist that I. NAMING INVENTORSHIP the subject matter of the reference was derived from the applicant in view of the relative dates. Ex parte The inventor, or each individual who is a joint Kusko, 215 USPQ 972, 974 (Bd. App. 1981) (The inventor of a claimed invention, in an application relative dates of the events are important in for patent (other than a provisional application) must determining derivation; a publication dated more execute an oath or declaration directed to the than a year after applicant's ®ling date that merely application, except as provided for in 37 CFR 1.64. lists as literary coauthors individuals other than See MPEP § 602.01(a) for the requirements of an applicant is not the strong evidence needed to rebut inventor's oath or declaration in an application ®led on or after September 16, 2012. See MPEP § 602.01(b) for the requirements of an original oath

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or declaration in an application ®led before biological properties of groups of complex chemical September 16, 2012. compounds is insuf®cient to confer inventorship status with respect to speci®cally claimed For applications ®led before September 16, 2012, compounds.º); Ex parte Smernoff, 215 USPQ 545, pre-AIA 37 CFR 1.41(a)(1) de®nes the inventorship 547 (Bd. App. 1982) (ªone who suggests an idea of of a nonprovisional application as that inventorship a result to be accomplished, rather than the means set forth in the oath or declaration ®led to comply of accomplishing it, is not an coinventorº). See with the requirements of pre-AIA 37 CFR 1.63, MPEP § 2138.04 - § 2138.05 for a discussion of except as otherwise provided. Thus the party or what evidence is required to establish conception or parties executing an oath or declaration under reduction to practice. pre-AIA 37 CFR 1.63 are presumed to be the inventors. Driscoll v. Cebalo, 5 USPQ2d 1477, 1481 III. AS LONG AS THE INVENTOR MAINTAINS (Bd. Pat. Inter. 1982); In re DeBaun, 687 F.2d 459, INTELLECTUAL DOMINATION OVER MAKING 463, 214 USPQ 933, 936 (CCPA 1982) (The THE INVENTION, IDEAS, SUGGESTIONS, AND inventor of an element, per se, and the inventor of MATERIALS MAY BE ADOPTED FROM OTHERS that element as used in a combination may differ. ªThe existence of combination claims does not ªIn arriving at ¼ conception [the inventor] may evidence inventorship by the patentee of the consider and adopt ideas and materials derived from individual elements or subcombinations thereof if many sources ¼ [such as] a suggestion from an the latter are not separately claimed apart from the employee, or hired consultant ¼ so long as he combination.º (quoting In re Facius, 408 F.2d 1396, maintains intellectual domination of the work of 1406, 161 USPQ 294, 301 (CCPA 1969) (emphasis making the invention down to the successful testing, in original)); Brader v. Schaeffer, 193 USPQ 627, selecting or rejecting as he goes¼even if such 631 (Bd. Pat. Inter. 1976) (in regard to an suggestion [or material] proves to be the key that inventorship correction: ª[a]s between inventors unlocks his problem.º Morse v. Porter, 155 USPQ their word is normally taken as to who are the actual 280, 283 (Bd. Pat. Inter. 1965). See also New inventorsº when there is no disagreement). England Braiding Co. v. A.W. Chesterton Co., 970 F.2d 878, 883, 23 USPQ2d 1622, 1626 (Fed. Cir. II. AN INVENTOR MUST CONTRIBUTE TO THE 1992) (Adoption of the ideas and materials from CONCEPTION OF THE INVENTION another can become a derivation.).

The de®nition for inventorship can be simply stated: IV. THE INVENTOR IS NOT REQUIRED TO ªThe threshold question in determining inventorship REDUCE THE INVENTION TO PRACTICE is who conceived the invention. Unless a person contributes to the conception of the invention, he is Dif®culties arise in separating members of a team not an inventor. ¼ Insofar as de®ning an inventor effort, where each member of the team has is concerned, reduction to practice, per se, is contributed something, into those members that irrelevant [except for simultaneous conception and actually contributed to the conception of the reduction to practice, Fiers v. Revel, 984 F.2d 1164, invention, such as the physical structure or operative 1168, 25 USPQ2d 1601, 1604-05 (Fed. Cir. 1993)]. steps, from those members that merely acted under One must contribute to the conception to be an the direction and supervision of the conceivers. inventor.º In re Hardee, 223 USPQ 1122, 1123 Fritsch v. Lin, 21 USPQ2d 1737, 1739 (Bd. Pat. (Comm'r Pat. 1984). See also Board of Education App. & Inter. 1991) (The inventor ªtook no part in ex rel. Board of Trustees of Florida State Univ. v. developing the procedures¼for expressing the EPO American Bioscience Inc., 333 F.3d 1330, 1340, 67 gene in mammalian host cells and isolating the USPQ2d 1252, 1259 (Fed. Cir. 2003) (ªInvention resulting EPO product.º However, ªit is not essential requires conception.º With regard to the inventorship for the inventor to be personally involved in carrying of chemical compounds, an inventor must have a out process steps¼where implementation of those conception of the speci®c compounds being claimed. steps does not require the exercise of inventive ª[G]eneral knowledge regarding the anticipated skill.º); In re DeBaun, 687 F.2d 459, 463, 214

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USPQ 933, 936 (CCPA 1982) (ªthere is no the contribution of that means was simply a requirement that the inventor be the one to reduce reduction to practice of the sole inventor's broader the invention to practice so long as the reduction to concept.º Ethicon Inc. v. United States Surgical practice was done on his behalfº). Corp., 135 F.3d 1456, 1460-63, 45 USPQ2d 1545, 1548-1551 (Fed. Cir. 1998) (The electronics See also Mattor v. Coolegem, 530 F.2d 1391, 1395, technician who contributed to one of the two 189 USPQ 201, 204 (CCPA 1976) (one following alternative structures in the speci®cation to de®ne oral instructions is viewed as merely a technician); ªthe means for detainingº in a claim limitation was Tucker v. Naito, 188 USPQ 260, 263 (Bd. Pat. Inter. held to be a joint inventor.). 1975) (inventors need not ªpersonally construct and test their inventionº); Davis v. Carrier, 81 F.2d 250, 2137.02 Applicability of Pre-AIA 35 U.S.C. 252, 28 USPQ 227, 229 (CCPA 1936) (noninventor's 103(c) [R-11.2013] work was merely that of a skilled mechanic carrying out the details of a plan devised by another). [Editor Note: This MPEP section is not applicable to applications subject to examination under the ®rst V. REQUIREMENTS FOR JOINT INVENTORSHIP inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et The inventive entity for a particular application is seq. to determine whether an application is subject based on some contribution to at least one of the to examination under the FITF provisions, and claims made by each of the named inventors. MPEP § 2150 et seq. for examination of applications ªInventors may apply for a patent jointly even subject to those provisions.] though (1) they did not physically work together or at the same time, (2) each did not make the same Pre-AIA 35 U.S.C. 103(c) states that subsection (f) type or amount of contribution, or (3) each did not of pre-AIA 35 U.S.C. 102 will not preclude make a contribution to the subject matter of every patentability where subject matter developed by claim of the patent.º 35 U.S.C. 116. ª[T]he statute another person, that would otherwise qualify under neither states nor implies that two inventors can be pre-AIA 35 U.S.C. 102(f), and the claimed invention `joint inventors' if they have had no contact of an application under examination were owned by whatsoever and are completely unaware of each the same person, subject to an obligation of other©s work.º What is required is some ªquantum assignment to the same person, or involved in a joint of collaboration or connection.º In other words, research agreement, which meets the requirements ª[f]or persons to be joint inventors under Section of pre-AIA 35 U.S.C. 103(c)(2) and (c)(3), at the 116, there must be some element of joint behavior, time the invention was made. See MPEP § 706.02(l) such as collaboration or working under common and § 2146. direction, one inventor seeing a relevant report and building upon it or hearing another's suggestion at Inventorship is generally ªby anotherº where there a meeting.º Kimberly-Clark Corp. v. Procter & are different inventive entities with at least one Gamble Distrib. Co., 973 F.2d 911, 916-17, 23 inventor in common. For case law relating to USPQ2d 1921, 1925-26 (Fed. Cir. 1992); Moler v. inventorship by ªanotherº involving different Purdy, 131 USPQ 276, 279 (Bd. Pat. Inter. 1960) inventive entities with at least one inventor in (ªit is not necessary that the inventive concept come common see Ex parte DesOrmeaux, 25 USPQ2d to both [joint inventors] at the same timeº). 2040 (Bd. Pat. App. & Inter. 1992) (the presence of a common inventor in a reference patent and a Each joint inventor must generally contribute to the pending application does not preclude the conception of the invention. A coinventor need not determination that the reference inventive entity is make a contribution to every claim of a patent. A to ªanotherº within the meaning of [pre-AIA] 35 contribution to one claim is enough. ªThe contributor U.S.C. 102(e)) and the discussion of prior art of any disclosed means of a means-plus-function claim element is a joint inventor as to that claim, unless one asserting sole inventorship can show that

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available under pre-AIA 35 U.S.C. 102(e) in MPEP 1129, 1132 (Fed. Cir. 1988); Kimberly-Clark v. § 2136.04. Johnson & Johnson, 745 F.2d 1437, 1444-46, 223 USPQ 603, 606-08 (Fed. Cir. 1984). To qualify as 2138 Pre-AIA 35 U.S.C. 102(g) [R-11.2013] prior art under pre-AIA 35 U.S.C. 102(g), however, there must be evidence that the subject matter was [Editor Note: This MPEP section has limited actually reduced to practice, in that conception alone applicability to applications subject to examination is not suf®cient. See Kimberly-Clark, 745 F.2d at under the ®rst inventor to ®le (FITF) provisions of 1445, 223 USPQ at 607. While the ®ling of an the AIA as set forth in 35 U.S.C. 100 (note). See application for patent is a constructive reduction to MPEP § 2159 et seq. to determine whether an practice, the ®ling of an application does not in itself application is subject to examination under the FITF provide the evidence necessary to show an actual provisions, MPEP § 2159.03 for the conditions under reduction to practice of any of the subject matter which this section applies to an AIA application, and disclosed in the application as is necessary to provide MPEP § 2150 et seq. for examination of applications the basis for an ex parte rejection under pre-AIA subject to those provisions.] 35 U.S.C. 102(g). Thus, absent evidence showing an actual reduction to practice (which is generally Pre-AIA 35 U.S.C. 102 Conditions for patentability; novelty not available during ex parte examination), the and loss of right to patent. disclosure of a United States patent application publication or patent falls under pre-AIA 35 U.S.C. A person shall be entitled to a patent unless - 102(e) and not under pre-AIA 35 U.S.C. 102(g). ***** Cf. In re Zletz, 893 F.2d 319, 323, 13 USPQ2d 1320, 1323 (Fed. Cir. 1990) (the disclosure in a reference (g) (1) during the course of an interference conducted under United States patent does not fall under pre-AIA 35 section 135 or section 291, another inventor involved therein U.S.C. 102(g) but under pre-AIA 35 U.S.C. 102(e)). establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or In addition, subject matter qualifying as prior art (2) before such person's invention thereof, the invention was only under pre-AIA 35 U.S.C. 102(g) may also be made in this country by another inventor who had not the basis for an ex parte rejection under pre-AIA abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not 35 U.S.C. 103. See In re Bass, 474 F.2d 1276, 1283, only the respective dates of conception and reduction to practice 177 USPQ 178, 183 (CCPA 1973) (in an of the invention, but also the reasonable diligence of one who unsuccessful attempt to utilize a 37 CFR 1.131 was ®rst to conceive and last to reduce to practice, from a time af®davit relating to a combination application, prior to conception by the other. applicants admitted that the subcombination screen Pre-AIA 35 U.S.C. 102(g) issues such as conception, of a copending application which issued as a patent reduction to practice and diligence, while more was earlier conceived than the combination). commonly applied to interference matters, also arise Pre-AIA 35 U.S.C. 103(c), however, states that in other contexts. subsection (g) of pre-AIA 35 U.S.C. 102 will not preclude patentability where subject matter Pre-AIA 35 U.S.C. 102(g) may form the basis for developed by another person, that would otherwise an ex parte rejection if: (1) the subject matter at qualify under pre-AIA 35 U.S.C. 102(g), and the issue has been actually reduced to practice by claimed invention of an application under another before the applicant's invention; and (2) examination were owned by the same person, subject there has been no abandonment, suppression or to an obligation of assignment to the same person, concealment. See, e.g., Amgen, Inc. v. Chugai or involved in a joint research agreement, which Pharmaceutical Co., 927 F.2d 1200, 1205, 18 meets the requirements of pre-AIA 35 U.S.C. USPQ2d 1016, 1020 (Fed. Cir. 1991); New Idea 103(c)(2) and (c)(3), at the time the invention was Farm Equipment Corp. v. Sperry Corp., 916 F.2d made. See MPEP § 706.02(l) and § 2146. 1561, 1566, 16 USPQ2d 1424, 1428 (Fed. Cir. 1990); E.I. DuPont de Nemours & Co. v. Phillips For additional examples of pre-AIA 35 U.S.C. Petroleum Co., 849 F.2d 1430, 1434, 7 USPQ2d 102(g) issues such as conception, reduction to

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practice and diligence outside the context of diligence from a time just prior to when the second interference matters, see In re Costello, 717 F.2d conceiver entered the ®eld to the ®rst conceiver's 1346, 219 USPQ 389 (Fed. Cir. 1983) (discussing reduction to practice. Hull v. Davenport, 90 F.2d the concepts of conception and constructive 103, 105, 33 USPQ 506, 508 (CCPA 1937). See the reduction to practice in the context of a declaration priority time charts below illustrating this point. under 37 CFR 1.131), and Kawai v. Metlesics, 480 Upon conclusion of an interference, subject matter F.2d 880, 178 USPQ 158 (CCPA 1973) (holding claimed by the losing party that was the basis of the constructive reduction to practice for priority under interference is rejected under pre-AIA 35 U.S.C. 35 U.S.C. 119 requires meeting the requirements of 102(g), unless the acts showing prior invention were 35 U.S.C. 101 and 35 U.S.C. 112). not in this country.

2138.01 Interference Practice [R-11.2013] It is noted that 35 U.S.C. 101 requires that whoever invents or discovers is the party who may obtain a [Editor Note: This MPEP section has limited patent for the particular invention or discovery. applicability to applications subject to examination 35 U.S.C. 111 (applicant) or 35 U.S.C. 116 under the ®rst inventor to ®le (FITF) provisions of (applicants) set forth the requirement that the actual the AIA as set forth in 35 U.S.C. 100 (note). See inventor(s) be the party who applies for a patent or MPEP § 2159 et seq. to determine whether an that a patent be applied for on behalf of the inventor. application is subject to examination under the FITF Where it can be shown that an applicant has provisions, MPEP § 2159.03 for the conditions under ªderivedº an invention from another, a rejection which this section applies to an AIA application, and under pre-AIA 35 U.S.C. 102(f) is proper. Ex parte MPEP § 2150 et seq. for examination of applications Kusko, 215 USPQ 972, 974 (Bd. App. 1981) (ªmost, subject to those provisions.] if not all, determinations under [pre-AIA] Section 102(f) involve the question of whether one party I. PRE-AIA 35 U.S.C. 102(g) IS THE BASIS OF derived an invention from anotherº); Price v. INTERFERENCE PRACTICE Symsek, 988 F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir. 1993) (Although derivation and Subsection (g) of pre-AIA 35 U.S.C. 102 is the basis priority of invention both focus on inventorship, of interference practice for determining priority of derivation addresses originality, i.e., who invented invention between two parties. See Bigham v. the subject matter, whereas priority focuses on which Godtfredsen, 857 F.2d 1415, 1416, 8 USPQ2d 1266, party invented the subject matter ®rst.). 1267 (Fed. Cir. 1988), 35 U.S.C. 135, 37 CFR Part 41, Subparts D and E and MPEP Chapter 2300. An II. PRIORITY TIME CHARTS interference is an inter partes proceeding directed at determining the ®rst to invent as among the parties The following priority time charts illustrate the to the proceeding, involving two or more pending award of invention priority in several situations. The applications naming different inventors or one or time charts apply to interference proceedings and more pending applications and one or more are also applicable to declarations or af®davits ®led unexpired patents naming different inventors. The under 37 CFR 1.131 to antedate references which United States is unusual in having a ®rst to invent are available as prior art under pre-AIA 35 U.S.C. rather than a ®rst to ®le system. Paulik v. Rizkalla, 102(a) or 102(e). Note, however, in the context of 760 F.2d 1270, 1272, 226 USPQ 224, 225 (Fed. Cir. 37 CFR 1.131, an applicant does not have to show 1985) (reviews the legislative history of the that the invention was not abandoned, suppressed, subsection in a concurring opinion by Judge Rich). or concealed from the time of an actual reduction to The ®rst of many to reduce an invention to practice practice to a constructive reduction to practice around the same time will be the sole party to obtain because the length of time taken to ®le a patent a patent, Radio Corp. of America v. Radio Eng'g application after an actual reduction to practice is Labs., Inc., 293 U.S. 1, 2, 21 USPQ 353, 353-4 generally of no consequence except in an (1934), unless another was the ®rst to conceive and interference proceeding. Paulik v. Rizkalla, 760 F.2d couple a later-in-time reduction to practice with 1270, 226 USPQ 224 (Fed. Cir. 1985). See the

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Example 3 discussion of abandonment, suppression, and concealment in MPEP § 2138.03.

For purposes of analysis under 37 CFR 1.131, the conception and reduction to practice of the reference to be antedated are both considered to be on the effective ®ling date of domestic patent or foreign patent or the date of printed publication.

In the charts, C = conception, R = reduction to practice (either actual or constructive), Ra = actual A is awarded priority in an interference in the absence of reduction to practice, Rc = constructive reduction to abandonment, suppression, or concealment from Ra to Rc, practice, and TD = commencement of diligence. because A conceived the invention before B, actually reduced the invention to practice before B reduced the invention to Example 1 practice, and did not abandon, suppress, or conceal the invention after actually reducing the invention to practice and before constructively reducing the invention to practice.

A antedates B as a reference in the context of a declaration or af®davit ®led under 37 CFR 1.131 because A conceived the invention before B and actually reduced the invention to practice before B reduced the invention to practice.

Example 4

A is awarded priority in an interference, or antedates B as a reference in the context of a declaration or af®davit ®led under 37 CFR 1.131, because A conceived the invention before B and constructively reduced the invention to practice before B reduced the invention to practice. The same result would be reached if the conception date was the same for both inventors A and B.

Example 2

A is awarded priority in an interference if A can show reasonable diligence from TD (a point just prior to B's conception) until Ra in the absence of abandonment, suppression, or concealment from Ra to Rc, because A conceived the invention before B, diligently actually reduced the invention to practice (after B reduced the invention to practice), and did not abandon, suppress, or conceal the invention after actually reducing the invention to practice and before constructively reducing the invention to practice.

A antedates B as a reference in the context of a declaration or af®davit ®led under 37 CFR 1.131 because A conceived the A is awarded priority in an interference, or antedates B as a invention before B, and diligently actually reduced the invention reference in the context of a declaration or af®davit ®led under to practice, even though this was after B reduced the invention 37 CFR 1.131, if A can show reasonable diligence from T (a D to practice. point just prior to B's conception) until Rc because A conceived the invention before B, and diligently constructively reduced the invention to practice even though this was after B reduced the invention to practice.

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III. 37 CFR 1.131 DOES NOT APPLY IN provisions, MPEP § 2159.03 for the conditions under INTERFERENCE PROCEEDINGS which this section applies to an AIA application, and MPEP § 2150 et seq. for examination of applications Interference practice operates to the exclusion of ex subject to those provisions.] parte practice under 37 CFR 1.131 which permits an applicant to show an actual date of invention prior An invention is made when there is a conception to the effective date of a reference or activity applied and a reduction to practice. Dunn v. Ragin, 50 USPQ under pre-AIA 35 U.S.C. 102 or 103, as long as the 472, 474 (Bd. Pat. Inter. 1941). Prior art under reference is not a statutory bar under pre-AIA 35 pre-AIA 35 U.S.C. 102(g) is limited to an invention U.S.C. 102(b) or a U.S. patent application that is made. In re Katz, 687 F.2d 450, 454, 215 publication claiming the same patentable invention. USPQ 14, 17 (CCPA 1982) (the publication of an Ex parte Standish, 10 USPQ2d 1454, 1457 (Bd. Pat. article, alone, is not deemed a constructive reduction App. & Inter. 1988) (An application claim to the to practice, and therefore its disclosure does not ªsame patentable inventionº claimed in a domestic prove that any invention within the meaning of patent requires interference rather than an af®davit pre-AIA 35 U.S.C. 102(g) has ever been made). under 37 CFR 1.131 to antedate the patent. The term ªsame patentable inventionº encompasses a claim Subject matter under pre-AIA 35 U.S.C. 102(g) is that is either anticipated by or obvious in view of available only if made in this country. Pre-AIA 35 the subject matter recited in the patent claim.). U.S.C. 104. Kondo v. Martel, 220 USPQ 47 (Bd. Subject matter which is prior art under pre-AIA 35 Pat. Inter. 1983) (acts of conception, reduction to U.S.C. 102(g) and is subject to an interference is not practice and diligence must be demonstrated in this open to further inquiry under 37 CFR 1.131 during country). Compare Colbert v. Lofdahl, 21 USPQ2d the interference proceeding. 1068, 1071 (Bd. Pat. App. & Inter. 1991) (ª[i]f the invention is reduced to practice in a foreign country IV. LOST COUNTS IN AN INTERFERENCE ARE and knowledge of the invention was brought into NOT, PER SE, STATUTORY PRIOR ART this country and disclosed to others, the inventor can derive no bene®t from the work done abroad and Loss of an interference count alone does not make such knowledge is merely evidence of conception its subject matter statutory prior art to losing party; of the inventionº). however, lost count subject matter that is available as prior art under 35 U.S.C. 102 may be used alone In accordance with pre-AIA 35 U.S.C. 102(g)(1), a or in combination with other references under 35 party involved in an interference proceeding under U.S.C. 103. But see In re Deckler, 977 F.2d 1449, pre-AIA 35 U.S.C. 135 or 291 may establish a date 24 USPQ2d 1448 (Fed. Cir. 1992) (Under the of invention under pre-AIA 35 U.S.C. 104. Pre-AIA principles of res judicata and collateral estoppel, 35 U.S.C. 104, as amended by GATT (Public Law Deckler was not entitled to claims that were 103-465, 108 Stat. 4809 (1994)) and NAFTA (Public patentably indistinguishable from the claim lost in Law 103-182, 107 Stat. 2057 (1993)), provides that interference even though the subject matter of the an applicant can establish a date of invention in a lost count was not available for use in an obviousness NAFTA member country on or after December 8, rejection under 35 U.S.C. 103.). 1993 or in WTO member country other than a NAFTA member country on or after January 1, 1996. 2138.02 ªThe Invention Was Made in This Accordingly, an interference count may be won or Countryº [R-11.2013] lost on the basis of establishment of invention by one of the parties in a NAFTA or WTO member [Editor Note: This MPEP section has limited country, thereby rendering the subject matter of that applicability to applications subject to examination count unpatentable to the other party under the under the ®rst inventor to ®le (FITF) provisions of principles of res judicata and collateral estoppel, the AIA as set forth in 35 U.S.C. 100 (note). See even though such subject matter is not available as MPEP § 2159 et seq. to determine whether an statutory prior art under pre-AIA 35 U.S.C. 102(g). application is subject to examination under the FITF

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See MPEP § 2138.01 regarding lost interference a patent application was ®led. The court held ®ling counts which are not statutory prior art. a patent application within 1 year of a public disclosure is not an unreasonable delay, therefore 2138.03 ªBy Another Who Has Not reasonable diligence must only be shown between Abandoned, Suppressed, or Concealed Itº the date of the actual reduction to practice and the [R-11.2013] public disclosure to avoid the inference of abandonment. [Editor Note: This MPEP section has limited applicability to applications subject to examination I. DURING AN INTERFERENCE PROCEEDING, AN INFERENCE OF SUPPRESSION OR under the ®rst inventor to ®le (FITF) provisions of CONCEALMENT MAY ARISE FROM DELAY IN the AIA as set forth in 35 U.S.C. 100 (note). See FILING PATENT APPLICATION MPEP § 2159 et seq. to determine whether an application is subject to examination under the FITF Once an invention is actually reduced to practice an provisions, MPEP § 2159.03 for the conditions under inventor need not rush to ®le a patent application. which this section applies to an AIA application, and Shindelar v. Holdeman, 628 F.2d 1337, 1341, MPEP § 2150 et seq. for examination of applications 207 USPQ 112, 116 (CCPA 1980). The length of subject to those provisions.] time taken to ®le a patent application after an actual reduction to practice is generally of no consequence Pre-AIA 35 U.S.C. 102(g) generally makes available except in an interference proceeding. Paulik v. as prior art within the meaning of 35 U.S.C. 103, the Rizkalla, 760 F.2d 1270, 1271, 226 USPQ 225, 226 prior invention of another who has not abandoned, (Fed. Cir. 1985) (suppression or concealment may suppressed or concealed it. In re Bass, 474 F.2d be deliberate or may arise due to an inference from 1276, 177 USPQ 178 (CCPA 1973); In re Suska, a ªtoo longº delay in ®ling a patent application). 589 F.2d 527, 200 USPQ 497 (CCPA 1979) (The Peeler v. Miller, 535 F.2d 647, 656, 190 USPQ result of applying the suppression and concealment 117,124 (CCPA 1976) (ªmere delay, without more, doctrine is that the inventor who did not conceal (but is not suf®cient to establish suppression or was the de facto last inventor) is treated legally as concealment.º ªWhat we are deciding here is that the ®rst to invent, while the de facto ®rst inventor Monsanto's delay is not `merely delay' and that who suppressed or concealed is treated as a later Monsanto©s justi®cation for the delay is inadequate inventor. The de facto ®rst inventor, by his to overcome the inference of suppression created by suppression and concealment, lost the right to rely the excessive delay.º The word ªmereº does not on his actual date of invention not only for priority imply a total absence of a limit on the duration of purposes, but also for purposes of avoiding the delay. Whether any delay is ªmereº is decided only invention of the counts as prior art.). on a case-by-case basis.).

ªThe courts have consistently held that an invention, Where a junior party in an interference relies upon though completed, is deemed abandoned, suppressed, an actual reduction to practice to demonstrate ®rst or concealed if, within a reasonable time after inventorship, and where the hiatus in time between completion, no steps are taken to make the invention the date for the junior party©s asserted reduction to publicly known. Thus failure to ®le a patent practice and the ®ling of its application is application; to describe the invention in a publicly unreasonably long, the hiatus may give rise to an disseminated document; or to use the invention inference that the junior party in fact suppressed or publicly, have been held to constitute abandonment, concealed the invention and the junior party will not suppression, or concealment.º Correge v. Murphy, be allowed to rely upon the earlier actual reduction 705 F.2d 1326, 1330, 217 USPQ 753, 756 (Fed. Cir. to practice. Young v. Dworkin, 489 F.2d 1277, 1280 1983) (quoting International Glass Co. v. United n.3, 180 USPQ 388, 391 n.3 (CCPA 1974) States, 408 F.2d 395, 403, 159 USPQ 434, 441 (Ct. (suppression and concealment issues are to be Cl. 1968)). In Correge, an invention was actually addressed on a case-by-case basis). reduced to practice, 7 months later there was a public disclosure of the invention, and 8 months thereafter

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II. SUPPRESSION OR CONCEALMENT NEED IV. ABANDONMENT NOT BE ATTRIBUTED TO INVENTOR A ®nding of suppression or concealment may not Suppression or concealment need not be attributed amount to a ®nding of abandonment wherein a right to the inventor. Peeler v. Miller, 535 F.2d 647, to a patent is lost. Steierman v. Connelly, 197 USPQ 653-54, 190 USPQ 117, 122 (CCPA 1976) (ªfour 288, 289 (Comm©r Pat. 1976); Correge v. Murphy, year delay from the time an inventor ¼ completes 705 F.2d 1326, 1329, 217 USPQ 753, 755 (Fed. Cir. his work ¼ and the time his assignee-employer ®les 1983) (an invention cannot be abandoned until it is a patent application is, prima facie, unreasonably ®rst reduced to practice). long in an interference with a party who ®led ®rstº); Shindelar v. Holdeman, 628 F.2d 1337, 1341-42, 2138.04 ªConceptionº [R-11.2013] 207 USPQ 112, 116-17 (CCPA 1980) (A patent attorney's workload will not preclude a holding of [Editor Note: This MPEP section has limited an unreasonable delayÐa total of 3 months was applicability to applications subject to examination identi®ed as possible of excuse in regard to the ®ling under the ®rst inventor to ®le (FITF) provisions of of an application.). the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et seq. to determine whether an III. INFERENCE OF SUPPRESSION OR application is subject to examination under the FITF CONCEALMENT IS REBUTTABLE provisions, MPEP § 2159.03 for the conditions under which this section applies to an AIA application, and Notwithstanding a ®nding of suppression or MPEP § 2150 et seq. for examination of applications concealment, a constructive reduction to practice subject to those provisions.] such as renewed activity just prior to other party's entry into ®eld coupled with the diligent ®ling of an Conception has been de®ned as ªthe complete application would still cause the junior party to performance of the mental part of the inventive actº prevail. Lutzker v. Plet, 843 F.2d 1364, 1367-69, 6 and it is ªthe formation in the mind of the inventor USPQ2d 1370, 1371-72 (Fed. Cir. 1988) (activities of a de®nite and permanent idea of the complete and directed towards commercialization not suf®cient operative invention as it is thereafter to be applied to rebut inference); Holmwood v. Cherpeck, 2 in practice¼.º Townsend v. Smith, 36 F.2d 292, USPQ2d 1942, 1945 (Bd. Pat. App. & Inter. 1986) 295, 4 USPQ 269, 271 (CCPA 1930). ª[C]onception (the inference of suppression or concealment may is established when the invention is made suf®ciently be rebutted by showing activity directed to perfecting clear to enable one skilled in the art to reduce it to the invention, preparing the application, or preparing practice without the exercise of extensive other compounds within the scope of the generic experimentation or the exercise of inventive skill.º invention); Engelhardt v. Judd, 369 F.2d 408, 411, Hiatt v. Ziegler, 179 USPQ 757, 763 (Bd. Pat. Inter. 151 USPQ 732, 735 (CCPA 1966) (ªWe recognize 1973). Conception has also been de®ned as a that an inventor of a new series of compounds should disclosure of an invention which enables one skilled not be forced to ®le applications piecemeal on each in the art to reduce the invention to a practical form new member as it is synthesized, identi®ed and without ªexercise of the inventive faculty.º Gunter tested for utility. A reasonable amount of time should v. Stream, 573 F.2d 77, 197 USPQ 482 (CCPA be allowed for completion of the research project on 1978). See also Coleman v. Dines, 754 F.2d 353, the whole series of new compounds, and a further 224 USPQ 857 (Fed. Cir. 1985) (It is settled that in reasonable time period should then be allowed for establishing conception a party must show drafting and ®ling the patent application(s) possession of every feature recited in the count, and thereon.º); Bogoslowsky v. Huse, 142 F.2d 75, 77, that every limitation of the count must have been 61 USPQ 349, 351 (CCPA 1944) (The doctrine of known to the inventor at the time of the alleged suppression and concealment is not applicable to conception. Conception must be proved by conception without an actual reduction to practice.). corroborating evidence.); Hybritech Inc. v. Monoclonal Antibodies Inc., 802 F. 2d 1367, 1376, 231 USPQ 81, 87 (Fed. Cir. 1986) (Conception is

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the ªformation in the mind of the inventor, of a III. CONCEPTION REQUIRES de®nite and permanent idea of the complete and CONTEMPORANEOUS RECOGNITION AND operative invention, as it is hereafter to be applied APPRECIATION OF THE INVENTION in practice.º) ; Hitzeman v. Rutter, 243 F.3d 1345, 58 USPQ2d 1161 (Fed. Cir. 2001) (Inventor's There must be a contemporaneous recognition and ªhopeº that a genetically altered yeast would produce appreciation of the invention for there to be antigen particles having the particle size and conception. Silvestri v. Grant, 496 F.2d 593, 596, sedimentation rates recited in the claims did not 181 USPQ 706, 708 (CCPA 1974) (ªan accidental establish conception, since the inventor did not show and unappreciated duplication of an invention does that he had a ªde®nite and permanent understandingº not defeat the patent right of one who, though later as to whether or how, or a reasonable expectation in time was the ®rst to recognize that which that, the yeast would produce the recited antigen constitutes the inventive subject matterº); particles.). Invitrogen, Corp. v. Clontech Laboratories, Inc., 429 F.3d 1052, 1064, 77 USPQ2d 1161, 1169 (Fed. I. CONCEPTION MUST BE DONE IN THE MIND Cir. 2005) (In situations where there is unrecognized OF THE INVENTOR accidental duplication, establishing conception requires evidence that the inventor actually made The inventor must form a de®nite and permanent the invention and understood the invention to have idea of the complete and operable invention to the features that comprise the inventive subject establish conception. Bosies v. Benedict, 27 F.3d matter at issue). Langer v. Kaufman, 465 F.2d 915, 539, 543, 30 USPQ2d 1862, 1865 (Fed. Cir. 1994) 918, 175 USPQ 172, 174 (CCPA 1972) (new form (Testimony by a noninventor as to the meaning of of catalyst was not recognized when it was ®rst a variable of a generic compound described in an produced; conception cannot be established nunc inventor's notebook was insuf®cient as a matter of pro tunc). However, an inventor does not need to law to establish the meaning of the variable because know that the invention will work for there to be the testimony was not probative of what the complete conception. Burroughs Wellcome Co. v. inventors conceived.). Barr Labs., Inc., 40 F.3d 1223, 1228, 32 USPQ2d 1915, 1919 (Fed. Cir. 1994) (Draft patent application II. AS LONG AS THE INVENTOR MAINTAINS disclosing treatment of AIDS with AZT reciting INTELLECTUAL DOMINATION OVER MAKING dosages, forms, and routes of administration was THE INVENTION, IDEAS, SUGGESTIONS, AND suf®cient to collaborate conception whether or not MATERIALS MAY BE ADOPTED FROM OTHERS the inventors believed the inventions would work based on initial screening tests.) Furthermore, the An inventor may consider and adopt ideas, inventor does not need to appreciate the patentability suggestions and materials derived from many of the invention. Dow Chem. Co. v. Astro-Valcour, sources: a suggestion from an employee, a hired Inc., 267 F.3d 1334, 1341, 60 USPQ2d 1519, 1523 consultant or a friend even if the adopted material (Fed. Cir. 2001). proves to be the key that unlocks the problem so long as the inventor ªmaintains intellectual The ®rst to conceive of a species is not necessarily domination of the work of making the invention the ®rst to conceive of the generic invention. In re down to the successful testing, selecting or Jolley, 308 F.3d 1317, 1323 n.2, 64 USPQ2d 1901, rejecting¼.º Morse v. Porter, 155 USPQ 280, 283 1905 n.2 (Fed. Cir. 2002). Further, while conception (Bd. Pat. Inter. 1965); Staehelin v. Secher, of a species within a genus may constitute 24 USPQ2d 1513, 1522 (Bd. Pat. App. & Inter. conception of the genus, conception of one species 1992) (ªevidence of conception naming only one of and the genus may not constitute conception of the actual inventive entity inures to the bene®t of another species in the genus. Oka v. Youssefyeh, and serves as evidence of conception by the complete 849 F.2d 581, 7 USPQ2d 1169 (Fed. Cir. 1988) inventive entityº). (conception of a chemical requires both the idea of the structure of the chemical and possession of an operative method of making it). See also Amgen v.

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Chugai Pharmaceutical Co., 927 F.2d 1200, 1206, SUBSEQUENT APPLICATION IS EVIDENCE 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (in the ONLY OF CONCEPTION isolation of a gene, de®ning a gene by its principal biological property is not suf®cient for conception An abandoned application with which no subsequent absent an ability to envision the detailed constitution application was copending serves to abandon bene®t as well as a method for obtaining it); Fiers v. Revel, of the application's ®ling as a constructive reduction 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1605 (Fed. to practice and the abandoned application is evidence Cir. 1993) (ª[b]efore reduction to practice, only of conception. In re Costello, 717 F.2d 1346, conception only of a process for making a substance, 1350, 219 USPQ 389, 392 (Fed. Cir. 1983). without conception of a structural or equivalent de®nition of that substance, can at most constitute 2138.05 ªReduction to Practiceº [R-11.2013] a conception of the substance claimed as a processº but cannot constitute conception of the substance; [Editor Note: This MPEP section has limited as ªconception is not enablement,º conception of a applicability to applications subject to examination puri®ed DNA sequence coding for a speci®c protein under the ®rst inventor to ®le (FITF) provisions of by function and a method for its isolation that could the AIA as set forth in 35 U.S.C. 100 (note). See be carried out by one of ordinary skill in the art is MPEP § 2159 et seq. to determine whether an not conception of that material). application is subject to examination under the FITF provisions, MPEP § 2159.03 for the conditions under On rare occasions conception and reduction to which this section applies to an AIA application, and practice occur simultaneously. Alpert v. Slatin, MPEP § 2150 et seq. for examination of applications 305 F.2d 891, 894, 134 USPQ 296, 299 (CCPA subject to those provisions.] 1962). ª[I]n some unpredictable areas of chemistry and biology, there is no conception until the Reduction to practice may be an actual reduction or invention has been reduced to practice.º MacMillan a constructive reduction to practice which occurs v. Moffett, 432 F.2d 1237, 1234-40, 167 USPQ 550, when a patent application on the claimed invention 552-553 (CCPA 1970). See also Hitzeman v. Rutter, is ®led. The ®ling of a patent application serves as 243 F.3d 1345, 58 USPQ2d 1161 (Fed. Cir. 2001) conception and constructive reduction to practice of (conception simultaneous with reduction to practice the subject matter described in the application. Thus where appellant lacked reasonable certainty that the inventor need not provide evidence of either yeast's performance of certain intracellular processes conception or actual reduction to practice when would result in the claimed antigen particles); Dunn relying on the content of the patent application. v. Ragin, 50 USPQ 472, 475 (Bd. Pat. Inter. 1941) Hyatt v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d (a new variety of asexually reproduced plant is 1128, 1130 (Fed. Cir. 1998). A reduction to practice conceived and reduced to practice when it is grown can be done by another on behalf of the inventor. and recognized as a new variety). Under these De Solms v. Schoenwald, 15 USPQ2d 1507, 1510 circumstances, conception is not complete if (Bd. Pat. App. & Inter. 1990). ªWhile the ®ling of subsequent experimentation reveals factual the original application theoretically constituted a uncertainty which ªso undermines the speci®city of constructive reduction to practice at the time, the the inventor's idea that it is not yet a de®nite and subsequent abandonment of that application also permanent re¯ection of the complete invention as it resulted in an abandonment of the bene®t of that will be used in practice.º Burroughs Wellcome Co. ®ling as a constructive reduction to practice. The v. Barr Labs., Inc., 40 F.3d 1223, 1229, 32 USPQ2d ®ling of the original application is, however, 1915, 1920 (Fed. Cir. 1994). evidence of conception of the invention.º In re Costello, 717 F.2d 1346, 1350, 219 USPQ 389, 392 IV. A PREVIOUSLY ABANDONED APPLICATION (Fed. Cir. 1983)(The second application was not WHICH WAS NOT COPENDING WITH A co-pending with the original application and it did not reference the original application. Because of the requirements of 35 U.S.C. 120 had not been satis®ed, the ®ling of the original application was

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not recognized as constructive reduction to practice read as describing subject matter other than that of of the invention.). the count and thus did not establish that the applicant was in possession of the invention of the count.). I. CONSTRUCTIVE REDUCTION TO PRACTICE See also Bigham v. Godtfredsen, 857 F.2d 1415, REQUIRES COMPLIANCE WITH 35 U.S.C. 112(a) 1417, 8 USPQ2d 1266, 1268 (Fed. Cir. 1988) (ª[t]he or PRE-AIA 35 U.S.C. 112, FIRST PARAGRAPH generic term halogen comprehends a limited number of species, and ordinarily constitutes a suf®cient When a party to an interference seeks the bene®t of written description of the common halogen species,º an earlier-®led U.S. patent application, the earlier except where the halogen species are patentably application must meet the requirements of 35 U.S.C. distinct). 120 and 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph for the subject matter of the count. II. REQUIREMENTS TO ESTABLISH ACTUAL The earlier application must meet the enablement REDUCTION TO PRACTICE requirement and must contain a written description of the subject matter of the interference count. Hyatt ªIn an interference proceeding, a party seeking to v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, establish an actual reduction to practice must satisfy 1130 (Fed. Cir. 1998). Proof of a constructive a two-prong test: (1) the party constructed an reduction to practice requires suf®cient disclosure embodiment or performed a process that met every under the ªhow to useº and ªhow to makeº element of the interference count, and (2) the requirements of 35 U.S.C. 112(a) or pre-AIA 35 embodiment or process operated for its intended U.S.C. 112, ®rst paragraph. Kawai v. Metlesics, 480 purpose.º Eaton v. Evans, 204 F.3d 1094, 1097, 53 F.2d 880, 886, 178 USPQ 158, 163 (CCPA 1973) USPQ2d 1696, 1698 (Fed. Cir. 2000). (A constructive reduction to practice is not proven unless the speci®cation discloses a practical utility The same evidence suf®cient for a constructive where one would not be obvious. Prior art which reduction to practice may be insuf®cient to establish disclosed an anticonvulsant compound which an actual reduction to practice, which requires a differed from the claimed compound only in the showing of the invention in a physical or tangible absence of a -CH2- group connecting two functional form that shows every element of the count. groups was not suf®cient to establish utility of the Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ claimed compound because the compounds were 223, 227 (CCPA 1976). For an actual reduction to not so closely related that they could be presumed practice, the invention must have been suf®ciently to have the same utility.). The purpose of the written tested to demonstrate that it will work for its intended description requirement is ªto ensure that the purpose, but it need not be in a commercially inventor had possession, as of the ®ling date of the satisfactory stage of development. See, e.g., Scott application relied on, of the speci®c subject matter v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, later claimed by him.º In re Edwards, 568 F.2d 1118-19 (Fed. Cir. 1994) (citing numerous cases 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). wherein the character of the testing necessary to The written description must include all of the support an actual reduction to practice varied with limitations of the interference count, or the applicant the complexity of the invention and the problem it must show that any absent text is necessarily solved). If a device is so simple, and its purpose and comprehended in the description provided and would ef®cacy so obvious, construction alone is suf®cient have been so understood at the time the patent to demonstrate workability. King Instrument Corp. application was ®led. Furthermore, the written v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, description must be suf®cient, when the entire 407 (Fed. Cir. 1985). speci®cation is considered, such that the ªnecessary and only reasonable constructionº that would be For additional cases pertaining to the requirements given it by a person skilled in the art is one that necessary to establish actual reduction to practice clearly supports each positive limitation in the count. see DSL Dynamic Sciences, Ltd. v. Union Switch & Hyatt v. Boone, 146 F.3d at 1354-55, 47 USPQ2d Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, at 1130-1132 (Fed. Cir. 1998) (The claim could be 1155 (Fed. Cir. 1991) (ªevents occurring after an

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alleged actual reduction to practice can call into recognition may not be used to show that a party had question whether reduction to practice has in fact contemporaneous appreciation of the invention. occurredº); Fitzgerald v. Arbib, 268 F.2d 763, However, evidence of subsequent testing may be 765-66, 122 USPQ 530, 531-32 (CCPA 1959) (ªthe admitted for the purpose of showing that an reduction to practice of a three-dimensional design embodiment was produced and that it met the invention requires the production of an article limitations of the count.º Cooper v. Goldfarb, 154 embodying that designº in ªother than a mere F.3d 1321, 1331, 47 USPQ2d 1896, 1904 (Fed. Cir. drawingº); Birmingham v. Randall, 171 F.2d 957, 1998) (citations omitted). Meitzner v. Corte, 537 80 USPQ 371, 372 (CCPA 1948) (To establish an F.2d 524, 528, 190 USPQ 407, 410 (CCPA 1976) actual reduction to practice of an invention directed (there can be no conception or reduction to practice to a method of making a product, it is not enough to of a new form or of a process using such a new form show that the method was performed. ª[S]uch an of an otherwise old composition where there has invention is not reduced to practice until it is been no recognition or appreciation of the existence established that the product made by the process is of the new form); Estee Lauder, Inc. v. L'Oreal S.A., satisfactory, and [ ] this may require successful 129 F.3d 588, 593, 44 USPQ2d 1610, 1615 (Fed. testing of the product.º). Cir. 1997) (ª[W]hen testing is necessary to establish utility, there must be recognition and appreciation III. TESTING REQUIRED TO ESTABLISH AN that the tests were successful for reduction to practice ACTUAL REDUCTION TO PRACTICE to occur.º A showing that testing was completed before the critical date, and that testing ultimately ªThe nature of testing which is required to establish proved successful, was held insuf®cient to establish a reduction to practice depends on the particular facts a reduction to practice before the critical date, since of each case, especially the nature of the invention.º the success of the testing was not appreciated or Gellert v. Wanberg, 495 F.2d 779, 783, 181 USPQ recognized until after the critical date.); Parker v. 648, 652 (CCPA 1974) (ªan invention may be tested Frilette, 462 F.2d 544, 547, 174 USPQ 321, 324 suf®ciently ¼ where less than all of the conditions (CCPA 1972) (ª[an] inventor need not understand of actual use are duplicated by the testsº); Wells v. precisely why his invention works in order to achieve Fremont, 177 USPQ 22, 24-5 (Bd. Pat. Inter. 1972) an actual reduction to practiceº). (ªeven where tests are conducted under `bench' or laboratory conditions, those conditions must `fully V. RECOGNITION OF THE INVENTION BY duplicate each and every condition of actual use' or ANOTHER MAY INURE TO THE BENEFIT OF if they do not, then the evidence must establish a THE INVENTOR relationship between the subject matter, the test condition and the intended functional setting of the ªInurement involves a claim by an inventor that, as invention,º but it is not required that all the a matter of law, the acts of another person should conditions of all actual uses be duplicated, such as accrue to the bene®t of the inventor.º Cooper v. rain, snow, mud, dust and submersion in water). Goldfarb, 154 F.3d 1321, 1331, 47 USPQ2d 1896, 1904 (Fed. Cir. 1998). Before a non-inventor's IV. REDUCTION TO PRACTICE REQUIRES recognition of the utility of the invention can inure RECOGNITION AND APPRECIATION OF THE to the bene®t of the inventor, the following INVENTION three-prong test must be met: (1) the inventor must have conceived of the invention, (2) the inventor The invention must be recognized and appreciated must have had an expectation that the embodiment for a reduction to practice to occur. ªThe rule that tested would work for the intended purpose of the conception and reduction to practice cannot be invention, and (3) the inventor must have submitted established nunc pro tunc simply requires that in the embodiment for testing for the intended purpose order for an experiment to constitute an actual of the invention. Genentech Inc. v. Chiron Corp., reduction to practice, there must have been 220 F.3d 1345, 1354, 55 USPQ2d 1636, 1643 (Fed. contemporaneous appreciation of the invention at Cir. 2000). In Genentech, a non-inventor hired by issue by the inventor¼. Subsequent testing or later the inventors to test yeast samples for the presence

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of the fusion protein encoded by the DNA construct does not recite any particular utility, evidence of the invention recognized the growth-enhancing establishing a substantial utility for any purpose is property of the fusion protein, but did not suf®cient to prove a reduction to practiceº; ªthe communicate this recognition to the inventors. The demonstrated similarity of ion exchange and court found that because the inventors did not submit adsorptive properties between the newly discovered the samples for testing growth-promoting activity, zeolites and known crystalline zeolites ¼ have the intended purpose of the invention, the third prong established utility for the zeolites of the countº); was not satis®ed and the uncommunicated Engelhardt v. Judd, 369 F.2d 408, 411, 151 USPQ recognition of the activity of the fusion protein by 732, 735 (CCPA 1966) (When considering an actual the non-inventor did not inure to their bene®t. See reduction to practice as a bar to patentability for also Cooper v. Goldfarb, 240 F.3d 1378, 1385, 57 claims to compounds, it is suf®cient to successfully USPQ2d 1990, 1995 (Fed. Cir. 2001) (Cooper sent demonstrate utility of the compounds in animals for to Goldfarb samples of a material for use in vascular somewhat different pharmaceutical purposes than grafts. At the time the samples were sent, Cooper those asserted in the speci®cation for humans.); was unaware of the importance of the ®bril length Rey-Bellet v. Engelhardt, 993 F.2d 1380, 1384, 181 of the material. Cooper did not at any time later USPQ 453, 455 (CCPA 1974) (Two categories of convey to, or request from, Goldfarb any information tests on laboratory animals have been considered regarding ®bril length. Therefore, Goldfarb's adequate to show utility and reduction to practice: determination of the ®bril lengths of the material ®rst, tests carried out to prove utility in humans could not inure to Cooper's bene®t.). where there is a satisfactory correlation between humans and animals, and second, tests carried out VI. IN AN INTERFERENCE PROCEEDING, ALL to prove utility for treating animals.). LIMITATIONS OF A COUNT MUST BE REDUCED TO PRACTICE VIII. A PROBABLE UTILITY MAY NOT BE SUFFICIENT TO ESTABLISH UTILITY The device reduced to practice must include every limitation of the count. Fredkin v. Irasek, 397 F.2d A probable utility does not establish a practical 342, 158 USPQ 280, 285 (CCPA 1968); every utility, which is established by actual testing or limitation in a count is material and must be proved where the utility can be ªforetold with certainty.º to establish an actual reduction to practice. Meitzner Bindra v. Kelly, 206 USPQ 570, 575 (Bd. Pat. Inter. v. Corte, 537 F.2d 524, 528, 190 USPQ 407, 410. 1979) (Reduction to practice was not established for See also Hull v. Bonis, 214 USPQ 731, 734 (Bd. an intermediate useful in the preparation of a second Pat. Inter. 1982) (no doctrine of intermediate with a known utility in the preparation equivalentsÐremedy is a preliminary motion to of a pharmaceutical. The record established there amend the count to conform to the proofs). was a high degree of probability of a successful preparation because one skilled in the art may have VII. CLAIMED INVENTION IS NOT ACTUALLY been motivated, in the sense of 35 U.S.C. 103, to REDUCED TO PRACTICE UNLESS THERE IS A prepare the second intermediate from the ®rst KNOWN UTILITY intermediate. However, a strong probability of utility is not suf®cient to establish practical utility.); Wu Utility for the invention must be known at the time v. Jucker, 167 USPQ 467, 472 (Bd. Pat. Inter. 1968) of the reduction to practice. Wiesner v. Weigert, 666 (screening test where there was an indication of F.2d 582, 588, 212 USPQ 721, 726 (CCPA 1981) possible utility is insuf®cient to establish practical (except for plant and design inventions); Azar v. utility). But see Nelson v. Bowler, 628 F.2d 853, Burns, 188 USPQ 601, 604 (Bd. Pat. Inter. 1975) (a 858, 206 USPQ 881, 885 (CCPA 1980) (Relevant composition and a method cannot be actually evidence is judged as a whole for its persuasiveness reduced to practice unless the composition and the in linking observed properties to suggested uses. product produced by the method have a practical utility); Ciric v. Flanigen, 511 F.2d 1182, 1185, 185 USPQ 103, 105-6 (CCPA 1975) (ªwhen a count

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Reasonable correlation between the two is suf®cient 191 USPQ 342, 345 (Bd. Pat. Inter. 1975)) or for an actual reduction to practice.). reliance upon priority under 35 U.S.C. 119 of a foreign application (Justus v. Appenzeller, 2138.06 ªReasonable Diligenceº [R-11.2013] 177 USPQ 332, 339 (Bd. Pat. Inter. 1971) (chain of priorities under 35 U.S.C. 119 and 120, priority [Editor Note: This MPEP section has limited under 35 U.S.C. 119 denied for failure to supply applicability to applications subject to examination certi®ed copy of the foreign application during under the ®rst inventor to ®le (FITF) provisions of pendency of the application ®led within the twelfth the AIA as set forth in 35 U.S.C. 100 (note). See month)). MPEP § 2159 et seq. to determine whether an application is subject to examination under the FITF II. THE ENTIRE PERIOD DURING WHICH provisions, MPEP § 2159.03 for the conditions under DILIGENCE IS REQUIRED MUST BE which this section applies to an AIA application, and ACCOUNTED FOR BY EITHER AFFIRMATIVE ACTS OR ACCEPTABLE EXCUSES MPEP § 2150 et seq. for examination of applications subject to those provisions.] An applicant must account for the entire period during which diligence is required. Gould v. The diligence of pre-AIA 35 U.S.C. 102(g) relates Schawlow, 363 F.2d 908, 919, 150 USPQ 634, 643 to reasonable ªattorney-diligenceº and (CCPA 1966) (Merely stating that there were no ªengineering-diligenceº (Keizer v. Bradley, 270 weeks or months that the invention was not worked F.2d 396, 397, 123 USPQ 215, 216 (CCPA 1959)), on is not enough.); In re Harry, 333 F.2d 920, 923, which does not require that ªan inventor or his 142 USPQ 164, 166 (CCPA 1964) (statement that attorney ¼ drop all other work and concentrate on the subject matter ªwas diligently reduced to the particular invention involved¼.º Emery v. practiceº is not a showing but a mere pleading). A Ronden, 188 USPQ 264, 268 (Bd. Pat. Inter. 1974). 2-day period lacking activity has been held to be fatal. In re Mulder, 716 F.2d 1542, 1545, 219 USPQ I. CRITICAL PERIOD FOR ESTABLISHING 189, 193 (Fed. Cir. 1983) (37 CFR 1.131 issue); DILIGENCE BETWEEN ONE WHO WAS FIRST TO CONCEIVE BUT LATER TO REDUCE TO Fitzgerald v. Arbib, 268 F.2d 763, 766, 122 USPQ PRACTICE THE INVENTION 530, 532 (CCPA 1959) (Less than 1 month of inactivity during critical period. Efforts to exploit The critical period for diligence for a ®rst conceiver an invention commercially do not constitute but second reducer begins not at the time of diligence in reducing it to practice. An actual conception of the ®rst conceiver but just prior to the reduction to practice in the case of a design for a entry in the ®eld of the party who was ®rst to reduce three-dimensional article requires that it should be to practice and continues until the ®rst conceiver embodied in some structure other than a mere reduces to practice. Hull v. Davenport, 90 F.2d 103, drawing.); Kendall v. Searles, 173 F.2d 986, 993, 105, 33 USPQ 506, 508 (CCPA 1937) (ªlack of 81 USPQ 363, 369 (CCPA 1949) (Diligence requires diligence from the time of conception to the time that applicants must be speci®c as to dates and immediately preceding the conception date of the facts.). second conceiver is not regarded as of importance except as it may have a bearing upon his subsequent The period during which diligence is required must actsº). What serves as the entry date into the ®eld be accounted for by either af®rmative acts or of a ®rst reducer is dependent upon what is being acceptable excuses. Rebstock v. Flouret, 191 USPQ relied on by the ®rst reducer, e.g., conception plus 342, 345 (Bd. Pat. Inter. 1975); Rieser v. Williams, reasonable diligence to reduction to practice (Fritsch 225 F.2d 419, 423, 118 USPQ 96, 100 (CCPA 1958) v. Lin, 21 USPQ2d 1731, 1734 (Bd. Pat. App. & (Being last to reduce to practice, party cannot prevail Inter. 1991), Emery v. Ronden, 188 USPQ 264, 268 unless he has shown that he was ®rst to conceive (Bd. Pat. Inter. 1974)); an actual reduction to practice and that he exercised reasonable diligence during or a constructive reduction to practice by the ®ling the critical period from just prior to opponent's entry of either a U.S. application (Rebstock v. Flouret, into the ®eld); Grif®th v. Kanamaru, 816 F.2d 624,

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2 USPQ2d 1361 (Fed. Cir. 1987) (Court generally were evidence of diligence. The court distinguished reviewed cases on excuses for inactivity including cases where diligence was not found because vacation extended by ill health and daily job inventors either discontinued development or failed demands, and held lack of university funding and to complete the invention while pursuing ®nancing personnel are not acceptable excuses.); Litch®eld or other commercial activity.); In re Jolley, 308 F.3d v. Eigen, 535 F.2d 72, 190 USPQ 113 (CCPA 1976) 1317, 1326-27, 64 USPQ2d 1901, 1908-09 (Fed. (budgetary limits and availability of animals for Cir. 2002) (diligence found based on research and testing not suf®ciently described); Morway v. Bondi, procurement activities related to the subject matter 203 F.2d 741, 749, 97 USPQ 318, 323 (CCPA 1953) of the interference count). ª[U]nder some (voluntarily laying aside inventive concept in pursuit circumstances an inventor should also be able to rely of other projects is generally not an acceptable on work on closely related inventions as support for excuse although there may be circumstances creating diligence toward the reduction to practice on an exceptions); Anderson v. Crowther, 152 USPQ 504, invention in issue.º Ginos v. Nedelec, 220 USPQ 512 (Bd. Pat. Inter. 1965) (preparation of routine 831, 836 (Bd. Pat. Inter. 1983) (work on other periodic reports covering all accomplishments of the closely related compounds that were considered to laboratory insuf®cient to show diligence); Wu v. be part of the same invention and which were Jucker, 167 USPQ 467, 472-73 (Bd. Pat. Inter. 1968) included as part of a grandparent application). ªThe (applicant improperly allowed test data sheets to work relied upon must be directed to attaining a accumulate to a suf®cient amount to justify reduction to practice of the subject matter of the interfering with equipment then in use on another counts. It is not suf®cient that the activity relied on project); Tucker v. Natta, 171 USPQ 494,498 (Bd. concerns related subject matter.º Gunn v. Bosch, Pat. Inter. 1971) (ª[a]ctivity directed toward the 181 USPQ 758, 761 (Bd. Pat. Inter. 1973) (An actual reduction to practice of a genus does not establish, reduction to practice of the invention at issue which prima facie, diligence toward the reduction to occurred when the inventor was working on a practice of a species embraced by said genusº); different invention ªwas fortuitous, and not the result Justus v. Appenzeller, 177 USPQ 332, 340-1 (Bd. of a continuous intent or effort to reduce to practice Pat. Inter. 1971) (Although it is possible that patentee the invention here in issue. Such fortuitousness is could have reduced the invention to practice in a inconsistent with the exercise of diligence toward shorter time by relying on stock items rather than reduction to practice of that invention.º 181 USPQ by designing a particular piece of hardware, patentee at 761. Furthermore, evidence drawn towards work exercised reasonable diligence to secure the required on improvement of samples or specimens generally hardware to actually reduce the invention to practice. already in use at the time of conception that are but ª[I]n deciding the question of diligence it is one element of the oscillator circuit of the count does immaterial that the inventor may not have taken the not show diligence towards the construction and expeditious course¼.º). testing of the overall combination.); Broos v. Barton, 142 F.2d 690, 691, 61 USPQ 447, 448 (CCPA 1944) III. WORK RELIED UPON TO SHOW (preparation of application in U.S. for foreign ®ling REASONABLE DILIGENCE MUST BE DIRECTLY constitutes diligence); De Solms v. Schoenwald, RELATED TO THE REDUCTION TO PRACTICE 15 USPQ2d 1507 (Bd. Pat. App. & Inter. 1990) (principles of diligence must be given to inventor's The work relied upon to show reasonable diligence circumstances including skill and time; requirement must be directly related to the reduction to practice of corroboration applies only to testimony of of the invention in issue. Naber v. Cricchi, 567 F.2d inventor); Huelster v. Reiter, 168 F.2d 542, 78 382, 384, 196 USPQ 294, 296 (CCPA 1977), cert. USPQ 82 (CCPA 1948) (if inventor was not able to denied, 439 U.S. 826 (1978). See also Scott v. make an actual reduction to practice of the invention, Koyama, 281 F.3d 1243, 1248-49, 61 USPQ2d 1856, he must also show why he was not able to 1859 (Fed. Cir. 2002) (Activities directed at building constructively reduce the invention to practice by a plant to practice the claimed process of producing the ®ling of an application). tetra¯uoroethane on a large scale constituted efforts toward actual reduction to practice, and thus

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IV. DILIGENCE REQUIRED IN PREPARING AND pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) FILING PATENT APPLICATION and MPEP § 2150 et seq.]

The diligence of attorney in preparing and ®ling 35 U.S.C. 103 Conditions for patentability; non-obvious subject matter patent application inures to the bene®t of the inventor. Conception was established at least as early A patent for a claimed invention may not be obtained, as the date a draft of a patent application was notwithstanding that the claimed invention is not identically ®nished by a patent attorney on behalf of the disclosed as set forth in section 102, if the differences between inventor. Conception is less a matter of signature the claimed invention and the prior art are such that the claimed than it is one of disclosure. Attorney does not prepare invention as a whole would have been obvious before the effective ®ling date of the claimed invention to a person having a patent application on behalf of particular named ordinary skill in the art to which the claimed invention pertains. persons, but on behalf of the true inventive entity. Patentability shall not be negated by the manner in which the Six days to execute and ®le application is acceptable. invention was made. Haskell v. Coleburne, 671 F.2d 1362, 213 USPQ Pre-AIA 35 U.S.C. 103 Conditions for patentability; 192, 195 (CCPA 1982). See also Bey v. Kollonitsch, nonobvious subject matter 866 F.2d 1024, 231 USPQ 967 (Fed. Cir. 1986) (Reasonable diligence is all that is required of the (a) A patent may not be obtained though the invention is attorney. Reasonable diligence is established if not identically disclosed or described as set forth in section 102, attorney worked reasonably hard on the application if the differences between the subject matter sought to be during the continuous critical period. If the attorney patented and the prior art are such that the subject matter as a has a reasonable backlog of unrelated cases which whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said he takes up in chronological order and carries out subject matter pertains. Patentability shall not be negatived by expeditiously, that is suf®cient. Work on a related the manner in which the invention was made. case(s) that contributed substantially to the ultimate ***** preparation of an application can be credited as diligence.). EXAMINATION GUIDELINES FOR DETERMINING OBVIOUSNESS UNDER 35 U.S.C. 103 V. END OF DILIGENCE PERIOD IS MARKED BY EITHER ACTUAL OR CONSTRUCTIVE REDUCTION TO PRACTICE These guidelines are intended to assist Of®ce personnel to make a proper determination of ª[I]t is of no moment that the end of that period [for obviousness under 35 U.S.C. 103, and to provide an diligence] is ®xed by a constructive, rather than an appropriate supporting rationale in view of the recent actual, reduction to practice.º Justus v. Appenzeller, decision by the Supreme Court in KSR International 177 USPQ 332, 340-41 (Bd. Pat. Inter. 1971). Co. v. Tele¯ex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007). The guidelines are based on the Of®ce's current understanding of the law, and are 2139 believed to be fully consistent with the binding -2140 [Reserved] precedent of the Supreme Court. The KSR decision reinforced earlier decisions that validated a more ¯exible approach to providing reasons for 2141 Examination Guidelines for obviousness. However, the Supreme Court's Determining Obviousness Under 35 U.S.C. pronouncement in KSR overruled cases such as In 103 [R-07.2015] re Lee, 277 F.3d 1338, 61 USPQ2d 1430 (Fed. Cir. 2002), insofar as those cases require record evidence [Editor Note: This MPEP section is applicable to of an express reason to modify the prior art. As the applications subject to the ®rst inventor to ®le Federal Circuit has explained: (FITF) provisions of the AIA except that the relevant date is the "effective ®ling date" of the claimed At the time [of the decision in In re Lee], we invention instead of the "time of the invention," required the PTO to identify record evidence which is only applicable to applications subject to

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of a teaching, suggestion, or motivation to by showing that the combination of elements was combine references because ª[o]mission of a `obvious to try'º (Id. at 421, USPQ2d at 1397); and relevant factor required by precedent is both (4) by overemphasizing ªthe risk of courts and patent legal error and arbitrary agency action.º examiners falling prey to hindsight biasº and as a However, this did not preclude examiners from result applying ª[r]igid preventative rules that deny employing common sense. More recently [in fact®nders recourse to common senseº (Id.). DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed.Cir. 2006)], we In KSR, the Supreme Court particularly emphasized explained that use of common sense does not ªthe need for caution in granting a patent based on require a ªspeci®c hint or suggestion in a the combination of elements found in the prior particular reference,º only a reasoned art,º Id. at 415, 82 USPQ2d at 1395, and discussed explanation that avoids conclusory circumstances in which a patent might be determined generalizations. to be obvious. Importantly, the Supreme Court reaf®rmed principles based on its precedent that ª[t]he combination of familiar elements according Perfect Web Technologies, Inc. v. InfoUSA, Inc., to known methods is likely to be obvious when it 587 F.3d 1324, 1329, 92 USPQ2d 1849, 1854 (Fed. does no more than yield predictable results.º Id. at Cir. 2009) (citations omitted). 415-16, 82 USPQ2d at 1395. The Supreme Court stated that there are ª[t]hree cases decided after These guidelines do not constitute substantive rule Graham [that] illustrate this doctrine.º Id. at 416, making and hence do not have the force and effect 82 USPQ2d at 1395. (1) ªIn United States v. Adams, of law. They have been developed as a matter of . . . [t]he Court recognized that when a patent claims internal Of®ce management and are not intended to a structure already known in the prior art that is create any right or bene®t, substantive or procedural, altered by the mere substitution of one element for enforceable by any party against the Of®ce. another known in the ®eld, the combination must Rejections will continue to be based upon the do more than yield a predictable result.º Id. (2) ªIn substantive law, and it is these rejections that are Anderson's-Black Rock, Inc. v. Pavement Salvage appealable. Consequently, any failure by Of®ce Co., . . . [t]he two [pre-existing elements] in personnel to follow the guidelines is neither combination did no more than they would in appealable nor petitionable. separate, sequential operation.º Id. at 416-17, 82 USPQ2d at 1395. (3) ª[I]n Sakraida v. AG Pro, Inc., I. THE KSR DECISION AND PRINCIPLES OF THE the Court derived . . . the conclusion that when a LAW OF OBVIOUSNESS patent simply arranges old elements with each performing the same function it had been known to The Supreme Court in KSR reaf®rmed the familiar perform and yields no more than one would expect framework for determining obviousness as set forth from such an arrangement, the combination is in Graham v. John Deere Co., 383 U.S. 1, 148 obvious.º Id. at 417, 82 USPQ2d at 1395-96 USPQ 459 (1966), but stated that the Federal Circuit (Internal quotations omitted.). The principles had erred by applying the underlining these cases are instructive when the teaching-suggestion-motivation (TSM) test in an question is whether a patent application claiming overly rigid and formalistic way. KSR, 550 U.S. at the combination of elements of prior art would have 404, 82 USPQ2d at 1391. Speci®cally, the Supreme been obvious. The Supreme Court further stated that: Court stated that the Federal Circuit had erred in four ways: (1) ªby holding that courts and patent examiners should look only to the problem the When a work is available in one ®eld of patentee was trying to solve º (Id. at 420, 82 endeavor, design incentives and other market USPQ2d at 1397); (2) by assuming ªthat a person forces can prompt variations of it, either in the of ordinary skill attempting to solve a problem will same ®eld or a different one. If a person of be led only to those elements of prior art designed ordinary skill can implement a predictable to solve the same problemº (Id.); (3) by concluding variation, § 103 likely bars its patentability. For ªthat a patent claim cannot be proved obvious merely the same reason, if a technique has been used

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to improve one device, and a person of ordinary Objective evidence relevant to the issue of skill in the art would recognize that it would obviousness must be evaluated by Of®ce personnel. improve similar devices in the same way, using Id. at 17-18, 148 USPQ at 467. Such evidence, the technique is obvious unless its actual sometimes referred to as ªsecondary considerations,º application is beyond his or her skill. Id. at may include evidence of commercial success, 417, 82 USPQ2d at 1396. long-felt but unsolved needs, failure of others, and unexpected results. The evidence may be included in the speci®cation as ®led, accompany the When considering obviousness of a combination of application on ®ling, or be provided in a timely known elements, the operative question is thus manner at some other point during the prosecution. ªwhether the improvement is more than the The weight to be given any objective evidence is predictable use of prior art elements according to made on a case-by-case basis. The mere fact that an their established functions.º Id. applicant has presented evidence does not mean that the evidence is dispositive of the issue of The Supreme Court's ¯exible approach to the obviousness. obviousness inquiry is re¯ected in numerous pre- KSR decisions; see MPEP § 2144. That section The question of obviousness must be resolved on provides many lines of reasoning to support a the basis of the factual inquiries set forth above. determination of obviousness based upon earlier While each case is different and must be decided on legal precedent that had condoned the use of its own facts, the Graham factors, including particular examples of what may be considered secondary considerations when present, are the common sense or ordinary routine practice (e.g., controlling inquiries in any obviousness analysis. making integral, changes in shape, making The Graham factors were reaf®rmed and relied adjustable). Thus, the type of reasoning sanctioned upon by the Supreme Court in its consideration and by the opinion in KSR has long been part of the determination of obviousness in the fact situation patent examination process. presented in KSR, 550 U.S. at 406-07, 82 USPQ2d at 1391 (2007). The Supreme Court has utilized the II. THE BASIC FACTUAL INQUIRES OF Graham factors in each of its obviousness decisions GRAHAM v. JOHN DEERE CO. since Graham. See Sakraida v. Ag Pro, Inc., 425 U.S. 273, 189 USPQ 449, reh'g denied, 426 U.S. An invention that would have been obvious to a 955 (1976); Dann v. Johnston, 425 U.S. 219, 189 person of ordinary skill at the time of the invention USPQ 257 (1976); and Anderson's-Black Rock, Inc. is not patentable. See 35 U.S.C. 103 or pre-AIA 35 v. Pavement Salvage Co., 396 U.S. 57, 163 USPQ U.S.C. 103(a). As reiterated by the Supreme Court 673 (1969). As stated by the Supreme Court in KSR, in KSR, the framework for the objective analysis ªWhile the sequence of these questions might be for determining obviousness under 35 U.S.C. 103 is reordered in any particular case, the [ Graham] stated in Graham v. John Deere Co., 383 U.S. 1, factors continue to de®ne the inquiry that 148 USPQ 459 (1966). Obviousness is a question controls.º KSR, 550 U.S. at 407, 82 USPQ2d at 1391. of law based on underlying factual inquiries. The factual inquiries enunciated by the Court are as Of®ce Personnel As Fact®nders follows:

(A) Determining the scope and content of the Of®ce personnel ful®ll the critical role of fact®nder prior art; and when resolving the Graham inquiries. It must be remembered that while the ultimate determination (B) Ascertaining the differences between the of obviousness is a legal conclusion, the underlying claimed invention and the prior art; and Graham inquiries are factual. When making an (C) Resolving the level of ordinary skill in the obviousness rejection, Of®ce personnel must pertinent art. therefore ensure that the written record includes ®ndings of fact concerning the state of the art and the teachings of the references applied. In certain

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circumstances, it may also be important to include might reasonably be expected to be claimed. See explicit ®ndings as to how a person of ordinary skill MPEP § 904.02. Although a rejection need not be would have understood prior art teachings, or what based on a teaching or suggestion to combine, a a person of ordinary skill would have known or could preferred search will be directed to ®nding references have done. Factual ®ndings made by Of®ce that provide such a teaching or suggestion if they personnel are the necessary underpinnings to exist. establish obviousness. 2. Where To Search: Once the ®ndings of fact are articulated, Of®ce personnel must provide an explanation to support Of®ce personnel should continue to follow the an obviousness rejection under 35 U.S.C. 103. 35 general search guidelines set forth in MPEP § 904 U.S.C. 132 requires that the applicant be noti®ed of to § 904.03 regarding search of the prior art. Of®ce the reasons for the rejection of the claim so that he personnel are reminded that, for purposes of 35 or she can decide how best to proceed. Clearly U.S.C. 103, prior art can be either in the ®eld of setting forth ®ndings of fact and the rationale(s) to applicant's endeavor or be reasonably pertinent to support a rejection in an Of®ce action leads to the the particular problem with which the applicant was prompt resolution of issues pertinent to patentability. concerned. See MPEP § 2141.01(a) for a discussion of analogous art. Furthermore, prior art that is in a In short, the focus when making a determination of ®eld of endeavor other than that of the applicant (as obviousness should be on what a person of ordinary noted by the Court in KSR, ª[w]hen a work is skill in the pertinent art would have known at the available in one ®eld of endeavor, design incentives time of the invention, and on what such a person and other market forces can prompt variations of it, would have reasonably expected to have been able either in the same ®eld or a different one,º 550 U.S. to do in view of that knowledge. This is so regardless at 417, 82 USPQ2d at 1396 (emphasis added)), or of whether the source of that knowledge and ability solves a problem which is different from that which was documentary prior art, general knowledge in the applicant was trying to solve, may also be the art, or common sense. What follows is a considered for the purposes of 35 U.S.C. 103. (The discussion of the Graham factual inquiries. Court in KSR stated that ª[t]he ®rst error¼in this case was¼holding that courts and patent examiners A. Determining the Scope and Content of the Prior Art should look only to the problem the patentee was trying to solve. The Court of Appeals failed to In determining the scope and content of the prior art, recognize that the problem motivating the patentee Of®ce personnel must ®rst obtain a thorough may be only one of many addressed by the patent's understanding of the invention disclosed and claimed subject matter¼The second error [was]¼that a in the application under examination by reading the person of ordinary skill attempting to solve a speci®cation, including the claims, to understand problem will be led only to those elements of prior what the applicant has invented. See MPEP § 904. art designed to solve the same problem.º 550 U.S. The scope of the claimed invention must be clearly at 420, 82 USPQ2d at 1397. Federal Circuit case determined by giving the claims the ªbroadest law prior to the Supreme Court's decision in KSR reasonable interpretation consistent with the is generally in accord with these statements by the speci®cation.º See Phillips v. AWH Corp., 415 F.3d KSR Court. See e.g., In re Dillon, 919 F.2d 688, 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) 693, 16 USPQ2d 1897, 1902 (Fed. Cir. 1990) (en and MPEP § 2111. Once the scope of the claimed banc) (ª[I]t is not necessary in order to establish a invention is determined, Of®ce personnel must then prima facie case of obviousness that both a determine what to search for and where to search. structural similarity between a claimed and prior art compound (or a key component of a composition) 1. What To Search For: be shown and that there be a suggestion in or expectation from the prior art that the claimed The search should cover the claimed subject matter compound or composition will have the same or a and should also cover the disclosed features which similar utility as one newly discovered by

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applicantº) (emphasis added); In re Lintner, 458 ªA person of ordinary skill in the art is also a person F.2d 1013, 1018, 173 USPQ 560, 562 (CCPA 1972) of ordinary creativity, not an automaton.º KSR, 550 (ªThe fact that [applicant] uses sugar for a different U.S. at 421, 82 USPQ2d at 1397. ª[I]n many cases purpose does not alter the conclusion that its use in a person of ordinary skill will be able to ®t the a prior art composition would be prima facie teachings of multiple patents together like pieces of obvious from the purpose disclosed in the a puzzle.º Id. at 420, 82 USPQ2d at 1397. Of®ce references.º). personnel may also take into account ªthe inferences and creative steps that a person of ordinary skill in For a discussion of what constitutes prior art, see the art would employ.º Id. at 418, 82 USPQ2d at MPEP § 901 to § 901.06(d) and § 2121 to § 2129. 1396. See MPEP § 2141.01(a) for a discussion of analogous art. In addition to the factors above, Of®ce personnel may rely on their own technical expertise to describe B. Ascertaining the Differences Between the Claimed the knowledge and skills of a person of ordinary skill Invention and the Prior Art in the art. The Federal Circuit has stated that examiners and administrative patent judges on the Ascertaining the differences between the claimed Board are ªpersons of scienti®c competence in the invention and the prior art requires interpreting the ®elds in which they workº and that their ®ndings claim language, see MPEP § 2111, and considering are ªinformed by their scienti®c knowledge, as to both the invention and the prior art as a whole. See the meaning of prior art references to persons of MPEP § 2141.02. ordinary skill in the art.º In re Berg, 320 F.3d 1310, 1315, 65 USPQ2d 2003, 2007 (Fed. Cir. 2003). In C. Resolving the Level of Ordinary Skill in the Art addition, examiners ªare assumed to have some expertise in interpreting the references and to be Any obviousness rejection should include, either familiar from their work with the level of skill in the explicitly or implicitly in view of the prior art art .º PowerOasis, Inc. v. T-Mobile USA, Inc., 522 applied, an indication of the level of ordinary skill. F.3d 1299, 86 USPQ2d 1385 (Fed. Cir. 2008) A ®nding as to the level of ordinary skill may be (quoting Am. Hoist & Derrick Co. v. Sowa & Sons, used as a partial basis for a resolution of the issue 725 F.2d 1350, 1360, 220 USPQ 763, 770 (Fed. Cir. of obviousness. 1984). See MPEP § 2141 for a discussion of the level of ordinary skill. The person of ordinary skill in the art is a hypothetical person who is presumed to have known III. RATIONALES TO SUPPORT REJECTIONS the relevant art at the time of the invention. Factors UNDER 35 U.S.C. 103 that may be considered in determining the level of ordinary skill in the art may include: (1) ªtype of Once the Graham factual inquiries are resolved, problems encountered in the art;º (2) ªprior art Of®ce personnel must determine whether the solutions to those problems;º (3) ªrapidity with claimed invention would have been obvious to one which innovations are made;º (4) ªsophistication of of ordinary skill in the art. the technology; andº (5) ªeducational level of active workers in the ®eld." In re GPAC, 57 F.3d 1573, The obviousness analysis cannot be con®ned 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995). "In by . . . overemphasis on the importance of a given case, every factor may not be present, and published articles and the explicit content of one or more factors may predominate.º Id. See also issued patents. . . . . In many ®elds it may be Custom Accessories, Inc. v. Jeffrey-Allan Indust., that there is little discussion of obvious Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. techniques or combinations, and it often may Cir. 1986); Environmental Designs, Ltd. V. Union be the case that market demand, rather than Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 scienti®c literature, will drive design (Fed. Cir. 1983). trends. KSR, 550 U.S. at 419, 82 USPQ2d at 1396.

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Prior art is not limited just to the references being other rationales set forth below support a conclusion applied, but includes the understanding of one of of obviousness. The Court in KSR identi®ed a ordinary skill in the art. The prior art reference (or number of rationales to support a conclusion of references when combined) need not teach or suggest obviousness which are consistent with the proper all the claim limitations, however, Of®ce personnel ªfunctional approachº to the determination of must explain why the difference(s) between the prior obviousness as laid down in Graham. KSR, 550 art and the claimed invention would have been U.S. at 415-21, 82 USPQ2d at 1395-97. Note that obvious to one of ordinary skill in the art. The ªmere the list of rationales provided below is not intended existence of differences between the prior art and to be an all-inclusive list. Other rationales to support an invention does not establish the invention's a conclusion of obviousness may be relied upon by nonobviousness.º Dann v. Johnston, 425 U.S. 219, Of®ce personnel. 230, 189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may not be The key to supporting any rejection under 35 U.S.C. ªso great as to render the [claim] nonobvious to one 103 is the clear articulation of the reason(s) why the reasonably skilled in the art.º Id . In determining claimed invention would have been obvious. The obviousness, neither the particular motivation to Supreme Court in KSR noted that the analysis make the claimed invention nor the problem the supporting a rejection under 35 U.S.C. 103 should inventor is solving controls. The proper analysis is be made explicit. The Court quoting In re Kahn, whether the claimed invention would have been 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. obvious to one of ordinary skill in the art after Cir. 2006), stated that ª`[R]ejections on obviousness consideration of all the facts. See 35 U.S.C. 103 or cannot be sustained by mere conclusory statements; pre-AIA 35 U.S.C. 103(a). Factors other than the instead, there must be some articulated reasoning disclosures of the cited prior art may provide a basis with some rational underpinning to support the legal for concluding that it would have been obvious to conclusion of obviousness.'º KSR, 550 U.S. at 418, one of ordinary skill in the art to bridge the gap. The 82 USPQ2d at 1396. Exemplary rationales that may rationales discussed below outline reasoning that support a conclusion of obviousness include: may be applied to ®nd obviousness in such cases. (A) Combining prior art elements according to If the search of the prior art and the resolution of the known methods to yield predictable results; Graham factual inquiries reveal that an obviousness (B) Simple substitution of one known element rejection may be made using the familiar for another to obtain predictable results; teaching-suggestion-motivation (TSM) rationale, then such a rejection should be made. Although the (C) Use of known technique to improve similar Supreme Court in KSR cautioned against an overly devices (methods, or products) in the same way; rigid application of TSM, it also recognized that (D) Applying a known technique to a known TSM was one of a number of valid rationales that device (method, or product) ready for improvement could be used to determine obviousness. (According to yield predictable results; to the Supreme Court, establishment of the TSM (E) ªObvious to tryº ± choosing from a ®nite approach to the question of obviousness ªcaptured number of identi®ed, predictable solutions, with a a helpful insight.º 550 U.S. at 418, 82 USPQ2d at reasonable expectation of success; 1396 (citing In re Bergel, 292 F.2d 955, 956-57, 130 USPQ 206, 207-208 (1961)). Furthermore, the (F) Known work in one ®eld of endeavor may Court explained that ª[t]here is no necessary prompt variations of it for use in either the same inconsistency between the idea underlying the TSM ®eld or a different one based on design incentives test and the Graham analysis.º 550 U.S. at 419, 82 or other market forces if the variations are USPQ2d at 1396. The Supreme Court also predictable to one of ordinary skill in the art; commented that the Federal Circuit ªno doubt has (G) Some teaching, suggestion, or motivation applied the test in accord with these principles [set in the prior art that would have led one of ordinary forth in KSR] in many cases.º Id. Of®ce personnel skill to modify the prior art reference or to combine should also consider whether one or more of the

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prior art reference teachings to arrive at the claimed success, long felt but unsolved needs, [and] failure invention. of othersº (Graham v. John Deere Co., 383 U.S. at See MPEP § 2143 for a discussion of the rationales 17, 148 USPQ at 467), and may also include listed above along with examples illustrating how evidence of unexpected results. As set forth above, the cited rationales may be used to support a ®nding Of®ce personnel must articulate ®ndings of fact that of obviousness. See also MPEP § 2144 - § 2144.09 support the rationale relied upon in an obviousness for additional guidance regarding support for rejection. As a result, applicants are likely to submit obviousness determinations. evidence to rebut the fact ®nding made by Of®ce personnel. For example, in the case of a claim to a combination, applicants may submit evidence or IV. APPLICANT'S REPLY argument to demonstrate that: Once Of®ce personnel have established the Graham (A) one of ordinary skill in the art could not have factual ®ndings and concluded that the claimed combined the claimed elements by known methods invention would have been obvious, the burden then (e.g., due to technological dif®culties); shifts to the applicant to (A) show that the Of®ce erred in these ®ndings or (B) provide other evidence (B) the elements in combination do not merely to show that the claimed subject matter would have perform the function that each element performs been nonobvious. 37 CFR 1.111(b) requires separately; or applicant to distinctly and speci®cally point out the (C) the results of the claimed combination were supposed errors in the Of®ce's action and reply to unexpected. every ground of objection and rejection in the Of®ce action. The reply must present arguments pointing Once the applicant has presented rebuttal evidence, out the speci®c distinction believed to render the Of®ce personnel should reconsider any initial claims patentable over any applied references. obviousness determination in view of the entire record. See, e.g., In re Piasecki, 745 F.2d 1468, If an applicant disagrees with any factual ®ndings 1472, 223 USPQ 785, 788 (Fed. Cir. 1984); In re by the Of®ce, an effective traverse of a rejection Eli Lilly & Co., 90 F.2d 943, 945, 14 USPQ2d 1741, based wholly or partially on such ®ndings must 1743 (Fed. Cir. 1990). All the rejections of record include a reasoned statement explaining why the and proposed rejections and their bases should be applicant believes the Of®ce has erred substantively reviewed to con®rm their continued viability. The as to the factual ®ndings. A mere statement or Of®ce action should clearly communicate the argument that the Of®ce has not established a prima Of®ce's ®ndings and conclusions, articulating how facie case of obviousness or that the Of®ce's the conclusions are supported by the ®ndings. The reliance on common knowledge is unsupported by procedures set forth in MPEP § 706.07(a) are to be documentary evidence will not be considered followed in determining whether an action may be substantively adequate to rebut the rejection or an made ®nal. effective traverse of the rejection under 37 CFR 1.111(b). Of®ce personnel addressing this situation See MPEP § 2145 concerning consideration of may repeat the rejection made in the prior Of®ce applicant's rebuttal evidence. See also MPEP § 716 action and make the next Of®ce action ®nal. See to § 716.10 regarding af®davits or declarations ®led MPEP § 706.07(a). under 37 CFR 1.132 for purposes of traversing grounds of rejection. V. CONSIDERATION OF APPLICANT'S REBUTTAL EVIDENCE 2141.01 Scope and Content of the Prior Art [R-11.2013] Of®ce personnel should consider all rebuttal evidence that is timely presented by the applicants [Editor Note: This MPEP section is applicable to when reevaluating any obviousness determination. applications subject to the ®rst inventor to ®le Rebuttal evidence may include evidence of (FITF) provisions of the AIA except that the relevant ªsecondary considerations,º such as ªcommercial date is the "effective ®ling date" of the claimed

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invention instead of the "time the invention was For an overview of what constitutes prior art under made," which is only applicable to applications 35 U.S.C. 102, see MPEP § 901 - § 901.06(d), subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 § 2121 - § 2129 and § 2151 - § 2155. (note) and MPEP § 2150 et seq.] II. SUBSTANTIVE CONTENT OF THE PRIOR ART I. PRIOR ART AVAILABLE UNDER 35 U.S.C. 102 IS AVAILABLE UNDER 35 U.S.C. 103 See MPEP § 2121 - § 2129 for case law relating to the substantive content of the prior art (e.g., ªBefore answering Graham's `content' inquiry, it availability of inoperative devices, extent to which must be known whether a patent or publication is in prior art must be enabling, broad disclosure rather the prior art under 35 U.S.C. § 102.º Panduit Corp. than preferred embodiments, admissions, etc.). v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, 1597 (Fed. Cir.), cert. denied, 481 III. CONTENT OF THE PRIOR ART IS U.S. 1052 (1987). Subject matter that is prior art DETERMINED AT THE TIME THE INVENTION under 35 U.S.C. 102 can be used to support a WAS MADE TO AVOID HINDSIGHT rejection under section 103. Ex parte Andresen, 212 USPQ 100, 102 (Bd. Pat. App. & Inter. 1981) (ªit The requirement ªat the time the invention was appears to us that the commentator [of 35 U.S.C.A.] madeº is to avoid impermissible hindsight. See and the [congressional] committee viewed section MPEP § 2145, subsection X.A. for a discussion of 103 as including all of the various bars to a patent rebutting applicants' arguments that a rejection is as set forth in section 102.º). based on hindsight.

Furthermore, admitted prior art can be relied upon ªIt is dif®cult but necessary that the decisionmaker for both anticipation and obviousness determinations, forget what he or she has been taught . . . about the regardless of whether the admitted prior art would claimed invention and cast the mind back to the time otherwise qualify as prior art under the statutory the invention was made (often as here many years), categories of 35 U.S.C. 102. Riverwood Int'l Corp. to occupy the mind of one skilled in the art. ...º W.L. v. R.A. Jones & Co., 324 F.3d 1346, 1354, 66 Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d USPQ2d 1331, 1337 (Fed. Cir. 2003); Constant v. 1540, 220 USPQ 303, 313 (Fed. Cir. 1983), cert. Advanced Micro-Devices Inc., 848 F.2d 1560, 1570, denied, 469 U.S. 851 (1984). 7 USPQ2d 1057, 1063 (Fed. Cir. 1988). See MPEP § 2129 for discussion of admissions as prior art. IV. PRE-AIA 35 U.S.C. 103(c) Ð EVIDENCE REQUIRED TO SHOW CONDITIONS OF PRE-AIA A 35 U.S.C. 103 rejection is based on 35 U.S.C. 35 U.S.C. 103(c) APPLY 102(a)(1) or (a)(2) or pre-AIA 35 U.S.C. 102(a), 102(b), 102(e), etc. depending on the type of prior An applicant subject to pre-AIA 35 U.S.C. 102 who art reference used and its publication or issue date. wants to avail himself or herself of the bene®ts of For instance, an obviousness rejection over a U.S. pre-AIA 35 U.S.C. 103(c) has the burden of patent which was issued more than 1 year before the establishing that subject matter which only quali®es ®ling date of the application subject to pre-AIA 35 as prior art under subsection (e), (f) or (g) of pre-AIA U.S.C. 102 is said to be a statutory bar just as if it 35 U.S.C. 102 used in a rejection under pre-AIA 35 anticipated the claims under pre-AIA 35 U.S.C. U.S.C. 103(a) and the claimed invention were, at the 102(b). Analogously, an obviousness rejection based time the invention was made, owned by the same on a publication which would be applied under person or subject to an obligation of assignment to pre-AIA 35 U.S.C. 102(a) if it anticipated the claims the same person. Ex parte Yoshino, 227 USPQ 52 can be overcome by swearing behind the publication (Bd. Pat. App. & Inter. 1985). Likewise, an applicant date of the reference by ®ling an af®davit or who wants to avail himself or herself of the bene®ts declaration under 37 CFR 1.131. of the joint research provisions of pre-AIA 35 U.S.C. 103(c) (for applications pending on or after

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December 10, 2004) has the burden of establishing pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) that: and MPEP § 2150 et seq.]

(A) the claimed invention was made by or on I. TO RELY ON A REFERENCE UNDER 35 U.S.C. behalf of parties to a joint research agreement that 103, IT MUST BE ANALOGOUS PRIOR ART was in effect on or before the date the claimed invention was made; In order for a reference to be proper for use in an (B) the claimed invention was made as a result obviousness rejection under 35 U.S.C. 103 , the of activities undertaken within the scope of the joint reference must be analogous art to the claimed research agreement; and invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). The examiner (C) the application for patent for the claimed must determine what is ªanalogous prior artº for the invention discloses or is amended to disclose the purpose of analyzing the obviousness of the subject names of the parties to the joint research agreement. matter at issue. ªUnder the correct analysis, any need This prior art disquali®cation is only applicable for or problem known in the ®eld of endeavor at the subject matter which only quali®es as prior art under time of the invention and addressed by the patent subsection (e), (f) or (g) of pre-AIA 35 U.S.C. 102 [or application at issue] can provide a reason for used in a rejection under pre-AIA 35 U.S.C. 103(a). combining the elements in the manner claimed. º KSR Int©l Co. v. Tele¯ex Inc., 550 U.S. 398, 420, Note that for applications ®led prior to November 82 USPQ2d 1385, 1397 (2007). This does not require 29, 1999, and granted as patents prior to December that the reference be from the same ®eld of endeavor 10, 2004, pre-AIA 35 U.S.C. 103(c) is limited on its as the claimed invention, in light of the Supreme face to subject matter developed by another person Court©s instruction that ª[w]hen a work is available which quali®es as prior art only under subsection in one ®eld of endeavor, design incentives and other (f) or (g) of pre-AIA 35 U.S.C. 102. See MPEP § market forces can prompt variations of it, either in 706.02(l)(1). See also In re Bartfeld, 925 F.2d 1450, the same ®eld or a different one.º Id. at 417, 82 1453-54, 17 USPQ2d 1885, 1888 (Fed. Cir. 1991) USPQ2d 1396. Rather, a reference is analogous art (Applicant attempted to overcome a pre-AIA 35 to the claimed invention if: (1) the reference is from U.S.C. 102(e)/103 rejection with a terminal the same ®eld of endeavor as the claimed invention disclaimer by alleging that the public policy intent (even if it addresses a different problem); or (2) the of pre-AIA 35 U.S.C 103(c) was to prohibit the use reference is reasonably pertinent to the problem of ªsecretº prior art in obviousness determinations. faced by the inventor (even if it is not in the same The court rejected this argument, holding ªWe may ®eld of endeavor as the claimed invention). See not disregard the unambiguous exclusion of § 102(e) Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. from the statute's purview.º). In order for a reference to be "reasonably pertinent" See MPEP § 706.02(l)(2) for the requirements which to the problem, it must ªlogically [] have commended must be met to establish common ownership or a itself to an inventor©s attention in considering his joint research agreement. problem. º In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In re 2141.01(a) Analogous and Nonanalogous Art Clay, 966 F.2d 656,658, 23 USPQ2 1058, 1061 (Fed. Cir. 1992)). A recent decision from the U.S. Court [R-08.2012] of Appeals for the Federal Circuit, In re Klein, 647 F.3d 1343, 98 USPQ2d 1991 (Fed. Cir. 2011), is [Editor Note: This MPEP section is applicable to instructive as to the "reasonably pertinent" prong for applications subject to the ®rst inventor to ®le determining whether a reference is analogous art. In (FITF) provisions of the AIA except that the relevant determining whether a reference is reasonably date is the "effective ®ling date" of the claimed pertinent, an examiner should consider the problem invention instead of the "time of the invention," faced by the inventor, as re¯ected - either explicitly which is only applicable to applications subject to or implicitly - in the speci®cation. In order to support

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a determination that a reference is reasonably III. ANALOGY IN THE CHEMICAL ARTS pertinent, it may be appropriate to include a statement of the examiner©s understanding of the See, for example, Ex parte Bland, 3 USPQ2d 1103 problem. The question of whether a reference is (Bd. Pat App. & Inter. 1986) (Claims were drawn reasonably pertinent often turns on how the problem to a particulate composition useful as a preservative to be solved is perceived. If the problem to be solved for an animal foodstuff (or a method of inhibiting is viewed in a narrow or constrained way, and such fungus growth in an animal foodstuff therewith) a view is not consistent with the speci®cation, the comprising verxite having absorbed thereon scope of available prior art may be inappropriately propionic acid. All references were concerned with limited. It may be necessary for the examiner to absorbing biologically active materials on carriers, explain why an inventor seeking to solve the and therefore the teachings in each of the various identi®ed problem would have looked to the references would have been pertinent to the problems reference in an attempt to ®nd a solution to the in the other references and the invention at hand.); problem, i.e., factual reasons why the prior art is Strato¯ex, Inc. v. Aeroquip Corp., 713 F.2d 1530, pertinent to the identi®ed problem. 218 USPQ 871 (Fed. Cir. 1983) (Problem confronting inventor was preventing electrostatic Any argument by the applicant that the examiner buildup in PTFE tubing caused by hydrocarbon fuel has misconstrued the problem to be solved, and as ¯ow while precluding leakage of fuel. Two prior art a result has improperly relied on nonanalogous art, references relied upon were in the rubber hose art, should be fully considered in light of the both referencing the problem of electrostatic buildup speci®cation. In evaluating the applicant©s argument, caused by fuel ¯ow. The court found that because the examiner should look to the teachings of the PTFE and rubber are used by the same hose speci®cation and the inferences that would manufacturers and experience the same and similar reasonably have been drawn from the speci®cation problems, a solution found for a problem by a person of ordinary skill in the art as a guide to experienced with either PTFE or rubber hosing understanding the problem to be solved. A prior art would be looked to when facing a problem with the reference not in the same ®eld of endeavor as the other.); In re Mlot-Fijalkowski, 676 F.2d 666, 213 claimed invention must be reasonably pertinent to USPQ 713 (CCPA 1982) (Problem faced by the problem to be solved in order to qualify as appellant was enhancement and immobilization of analogous art and be applied in an obviousness dye penetrant indications. References which taught rejection. the use of dyes and ®nely divided developer materials to produce colored images preferably in, II. CONSIDER SIMILARITIES AND but not limited to, the duplicating paper art were DIFFERENCES IN STRUCTURE AND FUNCTION properly relied upon because the court found that appellant's problem was one of dye chemistry, and While Patent Of®ce classi®cation of references and a search for its solution would include the dye arts the cross-references in the of®cial search notes of in general.). the class de®nitions are some evidence of ªnonanalogyº or ªanalogyº respectively, the court IV. ANALOGY IN THE MECHANICAL ARTS has found ªthe similarities and differences in structure and function of the inventions to carry far See, for example, Stevenson v. Int©l Trade Comm., greater weight.º In re Ellis, 476 F.2d 1370, 1372, 612 F.2d 546, 550, 204 USPQ 276, 280 (CCPA 177 USPQ 526, 527 (CCPA 1973) (The structural 1979) (ªIn a simple mechanical invention a broad similarities and functional overlap between the spectrum of prior art must be explored and it is structural gratings shown by one reference and the reasonable to permit inquiry into other areas where shoe scrapers of the type shown by another reference one of ordinary skill in the art would be aware that were readily apparent, and therefore the arts to which similar problems exist.º). See also In re Bigio, the reference patents belonged were reasonably 381 F.3d 1320, 1325-26, 72 USPQ2d 1209, 1211-12 pertinent to the art with which appellant's invention (Fed. Cir. 2004). The patent application claimed a dealt (pedestrian ¯oor gratings).). "hair brush" having a speci®c bristle con®guration.

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The Board af®rmed the examiner's rejection of the V. ANALOGY IN THE ELECTRICAL ARTS claims as being obvious in view of prior art patents disclosing toothbrushes. Id. at at 1323, 72 USPQ2d See, for example, Medtronic, Inc. v. Cardiac at 1210. The applicant disputed that the patent Pacemakers, 721 F.2d 1563, 220 USPQ 97 (Fed. references constituted analogous art. On appeal, the Cir. 1983) (Patent claims were drawn to a cardiac court upheld the Board's interpretation of the claim pacemaker which comprised, among other term ªhair brushº to encompass any brush that may components, a runaway inhibitor means for be used for any bodily hair, including facial hair. preventing a pacemaker malfunction from causing Id. at 1323-24, 72 USPQ2d at 1211. With this claim pulses to be applied at too high a frequency rate. interpretation, the court applied the ª®eld of Two references disclosed circuits used in high endeavor testº for analogous art and determined that power, high frequency devices which inhibited the the references were within the ®eld of applicant's runaway of pulses from a pulse source. The court endeavor and hence was analogous art because held that one of ordinary skill in the pacemaker toothbrushes are structurally similar to small brushes designer art faced with a rate-limiting problem would for hair, and a toothbrush could be used to brush look to the solutions of others faced with rate facial hair. Id. at 1326, 72 USPQ2d at 1212. limiting problems, and therefore the references were in an analogous art.). Also see In re Deminski, 796 F.2d 436, 230 USPQ 313 (Fed. Cir. 1986) (Applicant's claims related to VI. EXAMPLES OF ANALOGY IN THE DESIGN double-acting high pressure gas transmission line ARTS compressors in which the valves could be removed easily for replacement. The Board relied upon See MPEP § 1504.03 for a discussion of the relevant references which taught either a double-acting piston case law setting forth the general requirements for pump or a double-acting piston compressor. The analogous art in design applications. court agreed that since the cited pumps and compressors have essentially the same function and For examples of analogy in the design arts, see In structure, the ®eld of endeavor includes both types re Rosen, 673 F.2d 388, 213 USPQ 347 (CCPA of double-action piston devices for moving ¯uids.); 1982) (The design at issue was a coffee table of Pentec, Inc. v. Graphic Controls Corp., 776 F.2d contemporary styling. The court held designs of 309, 227 USPQ 766 (Fed. Cir. 1985) (Claims at issue contemporary furniture other than coffee tables, such were directed to an instrument marker pen body, the as the desk and circular glass table top designs of improvement comprising a pen arm holding means the references relied upon, would reasonably fall having an integrally molded hinged member for within the scope of the knowledge of the designer folding over against the pen body. Although the of ordinary skill.); Ex parte Pappas, 23 USPQ2d patent owners argued the hinge and fastener art was 1636 (Bd. Pat. App. & Inter. 1992) (At issue was an nonanalogous, the court held that the problem ornamental design for a feed bunk with an inclined confronting the inventor was the need for a simple corner con®guration. Examiner relied upon holding means to enable frequent, secure attachment references to a bunk lacking the inclined corners and easy removal of a marker pen to and from a pen claimed by appellant and the Architectural Precast arm, and one skilled in the pen art trying to solve Concrete Drafting Handbook. The Board found the that problem would have looked to the fastener and Architectural Precast Concrete Drafting Handbook hinge art.); and Ex parte Goodyear Tire & Rubber was analogous art, noting that a bunk may be a wood Co., 230 USPQ 357 (Bd. Pat. App. & Inter. 1985) or concrete trough, and that both references relied (A reference in the clutch art was held reasonably upon ªdisclose structures in which at least one pertinent to the friction problem faced by applicant, upstanding leg is generally perpendicular to a base whose claims were directed to a braking material, portion to de®ne a corner con®guration between the because brakes and clutches utilize interfacing leg and base portion.º); In re Butera, 1 F.3d 1252, materials to accomplish their respective purposes.). 28 USPQ2d 1399, 1400 (Fed. Cir. 1993) (unpublished - not citable as precedent) (The claimed invention, a spherical design for a combined insect

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repellent and air freshener, was rejected by the Board perceived a need for mechanisms to dampen as obvious over a single reference to a design for a resonance, whereas the inventor eliminated the need metal ball anode. The court reversed, holding the for dampening via the one-piece gapless support reference design to be nonanalogous art. ªA prior structure. ªBecause that insight was contrary to the design is of the type claimed if it has the same understandings and expectations of the art, the general use as that claimed in the design patent structure effectuating it would not have been obvious application . . . . One designing a combined insect to those skilled in the art.º 713 F.2d at 785, 218 repellent and air freshener would therefore not have USPQ at 700 (citations omitted).). reason to know of or look to a design for a metal ball anode.º). See also In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) (Claims were directed to a three step 2141.02 Differences Between Prior Art and process for preparing sweetened foods and drinks. Claimed Invention [R-08.2012] The ®rst two steps were directed to a process of producing high purity maltose (the sweetener), and [Editor Note: This MPEP section is applicable to the third was directed to adding the maltose to foods applications subject to the ®rst inventor to ®le and drinks. The parties agreed that the ®rst two steps (FITF) provisions of the AIA except that the relevant were unobvious but formed a known product and date is the "effective ®ling date" of the claimed the third step was obvious. The Solicitor argued the invention instead of the "time the invention was preamble was directed to a process for preparing made," which is only applicable to applications foods and drinks sweetened mildly and thus the subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 speci®c method of making the high purity maltose (note) and MPEP § 2150 et seq.] (the ®rst two steps in the claimed process) should not be given weight, analogizing with Ascertaining the differences between the prior art product-by-process claims. The court held ªdue to and the claims at issue requires interpreting the claim the admitted unobviousness of the ®rst two steps of language, and considering both the invention and the claimed combination of steps, the subject matter the prior art references as a whole. See MPEP § 2111 as a whole would not have been obvious to one of - § 2116.01 for case law pertaining to claim ordinary skill in the art at the time the invention was interpretation. made.º 535 F.2d at 69, 190 USPQ at 17 (emphasis in original). The preamble only recited the purpose I. THE CLAIMED INVENTION AS A WHOLE of the process and did not limit the body of the claim. MUST BE CONSIDERED Therefore, the claimed process was a three step process, not the product formed by two steps of the In determining the differences between the prior art process or the third step of using that product.). and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have II. DISTILLING THE INVENTION DOWN TO A been obvious, but whether the claimed invention as ªGISTº OR ªTHRUSTº OF AN INVENTION DISREGARDS ªAS A WHOLEº REQUIREMENT a whole would have been obvious. Strato¯ex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 Distilling an invention down to the ªgistº or ªthrustº (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 of an invention disregards the requirement of F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims analyzing the subject matter ªas a whole.º W.L. were directed to a vibratory testing machine (a Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, hard-bearing wheel balancer) comprising a holding 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 structure, a base structure, and a supporting means U.S. 851 (1984) (restricting consideration of the which form ªa single integral and gaplessly claims to a 10% per second rate of stretching of continuous piece.º Nortron argued the invention is unsintered PTFE and disregarding other limitations just making integral what had been made in four resulted in treating claims as though they read bolted pieces, improperly limiting the focus to a differently than allowed); Bausch & Lomb structural difference from the prior art and failing to v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, consider the invention as a whole. The prior art

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447-49, 230 USPQ 416, 419-20 (Fed. Cir. 1986), inherently present in molded or blown glass. The cert. denied, 484 U.S. 823 (1987) (District court court found the inventor discovered the cause of focused on the ªconcept of forming ridgeless moisture transmission was through the center plug, depressions having smooth rounded edges using a and there was no teaching in the prior art which laser beam to vaporize the material,º but would suggest the necessity of selecting applicant©s ªdisregarded express limitations that the product be plug material which was more impervious to liquids an ophthalmic lens formed of a transparent than the natural rubber plug of the prior art. cross-linked polymer and that the laser marks be surrounded by a smooth surface of unsublimated In In re Wiseman, 596 F.2d at 1022, 201 USPQ at polymer.º). See also Jones v. Hardy, 727 F.2d 1524, 661, claims directed to grooved carbon disc brakes 1530, 220 USPQ 1021, 1026 (Fed. Cir. 1984) wherein the grooves were provided to vent steam or (ªtreating the advantage as the invention disregards vapor during a braking action to minimize fading of statutory requirement that the invention be viewed the brakes were rejected as obvious over a reference `as a whole'º); Panduit Corp. v. Dennison Mfg. Co., showing carbon disc brakes without grooves in 810 F.2d 1561, 1 USPQ2d 1593 (Fed. Cir. 1987), combination with a reference showing grooves in cert. denied, 481 U.S. 1052 (1987) (district court noncarbon disc brakes for the purpose of cooling the improperly distilled claims down to a one word faces of the braking members and eliminating dust, solution to a problem). thereby reducing fading of the brakes. The court af®rmed the rejection, holding that even if applicants III. DISCOVERING SOURCE/CAUSE OF A discovered the cause of a problem, the solution PROBLEM IS PART OF ªAS A WHOLEº INQUIRY would have been obvious from the prior art which contained the same solution (inserting grooves in ª[A] patentable invention may lie in the discovery disc brakes) for a similar problem. of the source of a problem even though the remedy may be obvious once the source of the problem is IV. APPLICANTS ALLEGING DISCOVERY OF A identi®ed. This is part of the `subject matter as a SOURCE OF A PROBLEM MUST PROVIDE whole' which should always be considered in SUBSTANTIATING EVIDENCE determining the obviousness of an invention under 35 U.S.C. § 103.º In re Sponnoble, 405 F.2d 578, Applicants who allege they discovered the source 585, 160 USPQ 237, 243 (CCPA 1969). However, of a problem must provide evidence substantiating ªdiscovery of the cause of a problem . . does not the allegation, either by way of af®davits or always result in a patentable invention. . . . [A] declarations, or by way of a clear and persuasive different situation exists where the solution is assertion in the speci®cation. In re Wiseman, 596 obvious from prior art which contains the same F.2d 1019, 201 USPQ 658 (CCPA 1979) solution for a similar problem.º In re Wiseman, 596 (unsubstantiated statement of counsel was F.2d 1019, 1022, 201 USPQ 658, 661 (CCPA 1979) insuf®cient to show appellants discovered source of (emphasis in original). the problem); In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983) (Claims were directed In In re Sponnoble, the claim was directed to a to a method for redeeming merchandising coupons plural compartment mixing vial wherein a center which contain a UPC ª5-by-5º bar code wherein, seal plug was placed between two compartments for among other steps, the memory at each supermarket temporarily isolating a liquid-containing would identify coupons by manufacturer and compartment from a solids-containing compartment. transmit the data to a central computer to provide an The claim differed from the prior art in the selection audit thereby eliminating the need for clearinghouses of butyl rubber with a silicone coating as the plug and preventing retailer fraud. In challenging the material instead of natural rubber. The prior art propriety of an obviousness rejection, appellant recognized that leakage from the liquid to the solids argued he discovered the source of a problem compartment was a problem, and considered the (retailer fraud and manual clearinghouse operations) problem to be a result of moisture passing around and its solution. The court found appellant's the center plug because of microscopic ®ssures speci®cation did not support the argument that he

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discovered the source of the problem with respect would lead away from the claimed invention. W.L. to retailer fraud, and that the claimed invention failed Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, to solve the problem of manual clearinghouse 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 operations.). U.S. 851 (1984) (Claims were directed to a process of producing a porous article by expanding shaped, V. DISCLOSED INHERENT PROPERTIES ARE unsintered, highly crystalline PART OF ªAS A WHOLEº INQUIRY poly(tetra¯uoroethylene) (PTFE) by stretching said PTFE at a 10% per second rate to more than ®ve ªIn determining whether the invention as a whole times the original length. The prior art teachings would have been obvious under 35 U.S.C. 103, we with regard to unsintered PTFE indicated the must ®rst delineate the invention as a whole. In material does not respond to conventional plastics delineating the invention as a whole, we look not processing, and the material should be stretched only to the subject matter which is literally recited slowly. A reference teaching rapid stretching of in the claim in question... but also to those properties conventional plastic polypropylene with reduced of the subject matter which are inherent in the subject crystallinity combined with a reference teaching matter and are disclosed in the speci®cation. . . Just stretching unsintered PTFE would not suggest rapid as we look to a chemical and its properties when we stretching of highly crystalline PTFE, in light of the examine the obviousness of a composition of matter disclosures in the art that teach away from the claim, it is this invention as a whole, and not some invention, i.e., that the conventional polypropylene part of it, which must be obvious under 35 U.S.C. should have reduced crystallinity before stretching, 103.º In re Antonie, 559 F.2d 618, 620, 195 USPQ and that PTFE should be stretched slowly.). 6,8 (CCPA 1977) (emphasis in original) (citations omitted) (The claimed wastewater treatment device However, ªthe prior art's mere disclosure of more had a tank volume to contractor area of 0.12 gal./sq. than one alternative does not constitute a teaching ft. The court found the invention as a whole was the away from any of these alternatives because such ratio of 0.12 and its inherent property that the disclosure does not criticize, discredit, or otherwise claimed devices maximized treatment capacity discourage the solution claimed¼.º In re Fulton, regardless of other variables in the devices. The prior 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. art did not recognize that treatment capacity was a Cir. 2004). See also MPEP § 2123. function of the tank volume to contractor ratio, and therefore the parameter optimized was not 2141.03 Level of Ordinary Skill in the Art recognized in the art to be a result-effective [R-08.2012] variable.). See also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) (ªFrom the [Editor Note: This MPEP section is applicable to standpoint of patent law, a compound and all its applications subject to the ®rst inventor to ®le properties are inseparable.º). (FITF) provisions of the AIA except that the relevant date is the "effective ®ling date" of the claimed Obviousness cannot be predicated on what is not invention instead of the "time of the invention" or known at the time an invention is made, even if the "time the invention was made," which are only inherency of a certain feature is later established. In applicable to applications subject to pre-AIA 35 re Rijckaert, 9 F.2d 1531, 28 USPQ2d 1955 (Fed. U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP § Cir. 1993). See MPEP § 2112 for the requirements 2150 et seq.] of rejections based on inherency. I. FACTORS TO CONSIDER IN DETERMINING VI. PRIOR ART MUST BE CONSIDERED IN ITS LEVEL OF ORDINARY SKILL ENTIRETY, INCLUDING DISCLOSURES THAT TEACH AWAY FROM THE CLAIMS The person of ordinary skill in the art is a hypothetical person who is presumed to have known A prior art reference must be considered in its the relevant art at the time of the invention. Factors entirety, i.e., as a whole, including portions that that may be considered in determining the level of

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ordinary skill in the art may include: (A) ªtype of may be used to demonstrate the level of ordinary problems encountered in the art;º (B) ªprior art skill in the art. For example, the document may be solutions to those problems;º (C) ªrapidity with relevant to establishing "a motivation to combine which innovations are made;º (D) ªsophistication which is implicit in the knowledge of one of ordinary of the technology; andº (E) ªeducational level of skill in the art." Nat©l Steel Car, Ltd. v. Can. Pac. active workers in the ®eld. In a given case, every Ry., Ltd., 357 F.3d 1319, 1338, 69 USPQ2d 1641, factor may not be present, and one or more factors 1656 (Fed. Cir. 2004) (holding that a drawing made may predominate.º In re GPAC, 57 F.3d 1573, by an engineer that was not prior art can, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); nonetheless, ª... be used to demonstrate a motivation Custom Accessories, Inc. v. Jeffrey-Allan Indus., to combine implicit in the knowledge of one of Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. ordinary skill in the artº). Cir. 1986 ); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 II. SPECIFYING A PARTICULAR LEVEL OF (Fed. Cir. 1983). SKILL IS NOT NECESSARY WHERE THE PRIOR ART ITSELF REFLECTS AN APPROPRIATE ªA person of ordinary skill in the art is also a person LEVEL of ordinary creativity, not an automaton.º KSR Int©l Co. v. Tele¯ex Inc., 550 U.S. 398, 421, 82 USPQ2d If the only facts of record pertaining to the level of 1385, 1397 (2007). ª[I]n many cases a person of skill in the art are found within the prior art of ordinary skill will be able to ®t the teachings of record, the court has held that an invention may be multiple patents together like pieces of a puzzle.º held to have been obvious without a speci®c ®nding Id. at 420, 82 USPQ2d 1397. Of®ce personnel may of a particular level of skill where the prior art itself also take into account ªthe inferences and creative re¯ects an appropriate level. Chore-Time steps that a person of ordinary skill in the art would Equipment, Inc. v. Cumberland Corp., 713 F.2d 774, employ.º Id. at 418, 82 USPQ2d at 1396. 218 USPQ 673 (Fed. Cir. 1983). See also Okajima v. Bourdeau, 261 F.3d 1350, 1355, 59 USPQ2d The ªhypothetical `person having ordinary skill in 1795, 1797 (Fed. Cir. 2001). the art' to which the claimed subject matter pertains would, of necessity have the capability of III. ASCERTAINING LEVEL OF ORDINARY understanding the scienti®c and engineering SKILL IS NECESSARY TO MAINTAIN OBJECTIVITY principles applicable to the pertinent art.º Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. ªThe importance of resolving the level of ordinary & Inter. 1988) (The Board disagreed with the skill in the art lies in the necessity of maintaining examiner's de®nition of one of ordinary skill in the objectivity in the obviousness inquiry.º Ryko Mfg. art (a doctorate level engineer or scientist working Co. v. Nu-Star, Inc., 950 F.2d 714, 718, 21 USPQ2d at least 40 hours per week in semiconductor research 1053, 1057 (Fed. Cir. 1991). The examiner must or development), ®nding that the hypothetical person ascertain what would have been obvious to one of is not de®nable by way of credentials, and that the ordinary skill in the art at the time the invention was evidence in the application did not support the made, and not to the inventor, a judge, a layman, conclusion that such a person would require a those skilled in remote arts, or to geniuses in the art doctorate or equivalent knowledge in science or at hand. Environmental Designs, Ltd. v. Union Oil engineering.). Co., 713 F.2d 693, 218 USPQ 865 (Fed. Cir. 1983), cert. denied, 464 U.S. 1043 (1984). References which do not qualify as prior art because they postdate the claimed invention may be relied upon to show the level of ordinary skill in the art at 2142 Legal Concept of Prima Facie or around the time the invention was made. Ex parte Obviousness [R-07.2015] Erlich, 22 USPQ 1463 (Bd. Pat. App. & Inter. 1992). Moreover, documents not available as prior art The legal concept of prima facie obviousness is a because the documents were not widely disseminated procedural tool of examination which applies broadly

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to all arts. It allocates who has the burden of going hindsight must be avoided and the legal conclusion forward with production of evidence in each step of must be reached on the basis of the facts gleaned the examination process. See In re Rinehart, 531 from the prior art. F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA ESTABLISHING A PRIMA FACIE CASE OF 1972); In re Saunders, 444 F.2d 599, 170 USPQ OBVIOUSNESS 213 (CCPA 1971); In re Tif®n, 443 F.2d 394, 170 USPQ 88 (CCPA 1971), amended, 448 F.2d 791, The key to supporting any rejection under 35 U.S.C. 171 USPQ 294 (CCPA 1971); In re Warner, 379 103 is the clear articulation of the reason(s) why the F.2d 1011, 154 USPQ 173 (CCPA 1967), cert. claimed invention would have been obvious. The denied, 389 U.S. 1057 (1968). The examiner bears Supreme Court in KSR Int©l Co. v. Tele¯ex Inc., 550 the initial burden of factually supporting any prima U.S. 538, 418, 82 USPQ2d 1385, 1396 (2007) noted facie conclusion of obviousness. If the examiner that the analysis supporting a rejection under 35 does not produce a prima facie case, the applicant U.S.C. 103 should be made explicit. The Federal is under no obligation to submit secondary evidence Circuit has stated that "rejections on obviousness to show nonobviousness. If, however, the examiner cannot be sustained with mere conclusory does produce a prima facie case, the burden of statements; instead, there must be some articulated coming forward with evidence or arguments shifts reasoning with some rational underpinning to support to the applicant who may submit additional evidence the legal conclusion of obviousness.º In re Kahn, of nonobviousness, such as comparative test data 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. showing that the claimed invention possesses Cir. 2006); see also KSR, 550 U.S. at 418, 82 improved properties not expected by the prior art. USPQ2d at 1396 (quoting Federal Circuit statement The decision of whether to submit evidence after a with approval). rejection should be in¯uenced by the goals of compact prosecution, which encourages the early It remains true that ª[t]he determination of submission of such evidence. It is also noted that obviousness is dependent on the facts of each case.º evidence submitted after ®nal rejection may be Sano®-Synthelabo v. Apotex, Inc., 550 F.3d 1075, denied entry into the record. The initial evaluation 1089, 89 USPQ2d 1370, 1379 (Fed. Cir. 2008) of prima facie obviousness thus relieves both the (citing Graham, 383 U.S. at 17-18, 148 USPQ 459, examiner and applicant from evaluating evidence 467 (1966)). If the examiner determines there is beyond the prior art and the evidence in the factual support for rejecting the claimed invention speci®cation as ®led until the art has been shown to under 35 U.S.C. 103, the examiner must then render obvious the claimed invention. consider any evidence supporting the patentability of the claimed invention, such as any evidence in To reach a proper determination under 35 U.S.C. the speci®cation or any other evidence submitted by 103, the examiner must step backward in time and the applicant. The ultimate determination of into the shoes worn by the hypothetical ªperson of patentability is based on the entire record, by a ordinary skill in the artº when the invention was preponderance of evidence, with due consideration unknown and just before it was made. In view of all to the persuasiveness of any arguments and any factual information, the examiner must then make a secondary evidence. In re Oetiker, 977 F.2d 1443, determination whether the claimed invention ªas a 24 USPQ2d 1443 (Fed. Cir. 1992). The legal wholeº would have been obvious at that time to that standard of ªa preponderance of evidenceº requires person. Knowledge of applicant's disclosure must the evidence to be more convincing than the be put aside in reaching this determination, yet kept evidence which is offered in opposition to it. With in mind in order to determine the ªdifferences,º regard to rejections under 35 U.S.C. 103, the conduct the search and evaluate the ªsubject matter examiner must provide evidence which as a whole as a wholeº of the invention. The tendency to resort shows that the legal determination sought to be to ªhindsightº based upon applicant©s disclosure is proved (i.e., the reference teachings establish a often dif®cult to avoid due to the very nature of the prima facie case of obviousness) is more probable examination process. However, impermissible than not.

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When an applicant submits evidence, whether in the Cir. 2009), the Federal Circuit offered additional speci®cation as originally ®led or in reply to a instruction as to the need for an explicit analysis. rejection, the examiner must reconsider the The Federal Circuit explained that the Supreme patentability of the claimed invention. The decision Court's requirement for an explicit analysis does not on patentability must be made based upon require record evidence of an explicit teaching of a consideration of all the evidence, including the motivation to combine in the prior art. evidence submitted by the examiner and the evidence submitted by the applicant. A decision to make or "[T]he analysis that "should be made explicit" refers maintain a rejection in the face of all the evidence not to the teachings in the prior art of a motivation must show that it was based on the totality of the to combine, but to the court's analysis. . . . Under evidence. Facts established by rebuttal evidence must the ¯exible inquiry set forth by the Supreme Court, be evaluated along with the facts on which the the district court therefore erred by failing to take conclusion of obviousness was reached, not against account of ©the inferences and creative steps,© or even the conclusion itself. In re Eli Lilly & Co., 902 F.2d routine steps, that an inventor would employ and by 943, 14 USPQ2d 1741 (Fed. Cir. 1990). failing to ®nd a motivation to combine related pieces from the prior art." Ball Aerosol, 555 F.3d at 993, See In re Piasecki, 745 F.2d 1468, 223 USPQ 785 89 USPQ2d at 1877. (Fed. Cir. 1984) for a discussion of the proper roles of the examiner's prima facie case and applicant's The Federal Circuit's directive in Ball Aerosol was rebuttal evidence in the ®nal determination of addressed to a lower court, but it applies to Of®ce obviousness. See MPEP § 706.02(j) for a discussion personnel as well. When setting forth a rejection, of the proper contents of a rejection under 35 U.S.C. Of®ce personnel are to continue to make appropriate 103. ®ndings of fact as explained in MPEP § 2141 and § 2143, and must provide a reasoned explanation as 2143 Examples of Basic Requirements of a to why the invention as claimed would have been Prima Facie Case of Obviousness [R-08.2012] obvious to a person of ordinary skill in the art at the time of the invention. This requirement for [Editor Note: This MPEP section is applicable to explanation remains even in situations in which applications subject to the ®rst inventor to ®le Of®ce personnel may properly rely on intangible (FITF) provisions of the AIA except that the relevant realities such as common sense and ordinary date is the "effective ®ling date" of the claimed ingenuity. invention instead of the "time of the invention" or "time the invention was made," which are only I. EXEMPLARY RATIONALES applicable to applications subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP § Exemplary rationales that may support a conclusion 2150 et seq.] of obviousness include:

The Supreme Court in KSR Int©l Co. v. Tele¯ex Inc., (A) Combining prior art elements according to 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 known methods to yield predictable results; (2007) identi®ed a number of rationales to support (B) Simple substitution of one known element a conclusion of obviousness which are consistent for another to obtain predictable results; with the proper ªfunctional approachº to the (C) Use of known technique to improve similar determination of obviousness as laid down in devices (methods, or products) in the same way; Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the (D) Applying a known technique to a known reason(s) why the claimed invention would have device (method, or product) ready for improvement been obvious. The Supreme Court in KSR noted to yield predictable results; that the analysis supporting a rejection under 35 (E) ªObvious to tryº ± choosing from a ®nite U.S.C. 103 should be made explicit. In Ball Aerosol number of identi®ed, predictable solutions, with a v. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed. reasonable expectation of success;

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(F) Known work in one ®eld of endeavor may A. Combining Prior Art Elements According to Known prompt variations of it for use in either the same Methods To Yield Predictable Results ®eld or a different one based on design incentives or other market forces if the variations are To reject a claim based on this rationale, Of®ce predictable to one of ordinary skill in the art; personnel must resolve the Graham factual (G) Some teaching, suggestion, or motivation inquiries. Then, Of®ce personnel must articulate the in the prior art that would have led one of ordinary following: skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed (1) a ®nding that the prior art included each invention. element claimed, although not necessarily in a single prior art reference, with the only difference between Note that the list of rationales provided is not the claimed invention and the prior art being the lack intended to be an all-inclusive list. Other rationales of actual combination of the elements in a single to support a conclusion of obviousness may be relied prior art reference; upon by Of®ce personnel. Any rationale employed (2) a ®nding that one of ordinary skill in the art must provide a link between the factual ®ndings and could have combined the elements as claimed by the legal conclusion of obviousness. known methods, and that in combination, each element merely performs the same function as it It is important for Of®ce personnel to recognize that does separately; when they do choose to formulate an obviousness rejection using one of the rationales suggested by (3) a ®nding that one of ordinary skill in the art the Supreme Court in KSR and discussed herein, would have recognized that the results of the they are to adhere to the guidance provided regarding combination were predictable; and the necessary factual ®ndings. It remains Of®ce (4) whatever additional ®ndings based on the policy that appropriate factual ®ndings are required Graham factual inquiries may be necessary, in view in order to apply the enumerated rationales properly. of the facts of the case under consideration, to explain a conclusion of obviousness. The subsections below include discussions of each The rationale to support a conclusion that the claim rationale along with examples illustrating how the would have been obvious is that all the claimed cited rationales may be used to support a ®nding of elements were known in the prior art and one skilled obviousness. Some examples use the facts of in the art could have combined the elements as pre- KSR cases to show how the rationales suggested claimed by known methods with no change in their by the Court in KSR may be used to support a respective functions, and the combination yielded ®nding of obviousness. The cases cited (from which nothing more than predictable results to one of the facts were derived) may not necessarily stand ordinary skill in the art. KSR, 550 U.S. at 416, 82 for the proposition that the particular rationale is the USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 basis for the court's holding of obviousness, but they U.S. 273, 282, 189 USPQ 449, 453 (1976); do illustrate consistency of past decisions with the Anderson's-Black Rock, Inc. v. Pavement Salvage lines of reasoning laid out in KSR. Other examples Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); are post- KSR decisions that show how the Federal Great Atl. & P. Tea Co. v. Supermarket Equip. Circuit has applied the principles of KSR. Cases are Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). included that illustrate ®ndings of obviousness as ª[I]t can be important to identify a reason that would well as nonobviousness. Note that, in some instances, have prompted a person of ordinary skill in the a single case is used in different subsections to relevant ®eld to combine the elements in the way illustrate the use of more than one rationale to the claimed new invention does.º KSR, 550 U.S. at support a ®nding of obviousness. It will often be the 418, 82 USPQ2d at 1396. If any of these ®ndings case that, once the Graham inquiries have been cannot be made, then this rationale cannot be used satisfactorily resolved, a conclusion of obviousness to support a conclusion that the claim would have may be supported by more than one line of been obvious to one of ordinary skill in the art. reasoning.

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Example 1: showed the two elements of the claimed invention ± screw The claimed invention in Anderson's-Black Rock, Inc. v. anchor and metal bracket ± used together. The court found that Pavement Salvage Co., 396 U.S. 57, 163 USPQ 673 (1969) was ªartisans knew that a foundation underpinning system requires a paving machine which combined several well-known elements a means of connecting the foundation to the load-bearing onto a single chassis. Standard prior art paving machines member.º Id. at 1276, 69 USPQ2d at 1691. typically combined equipment for spreading and shaping asphalt onto a single chassis. The patent claim included the well-known The nature of the problem to be solved ± underpinning unstable element of a radiant-heat burner attached to the side of the paver foundations ± as well as the need to connect the member to the for the purpose of preventing cold joints during continuous strip foundation to accomplish this goal, would have led one of paving. The prior art used radiant heat for softening the asphalt ordinary skill in the art to choose an appropriate load bearing to make patches, but did not use radiant heat burners to achieve member and a compatible attachment. Therefore, it would have continuous strip paving. All of the component parts were known been obvious to use a metal bracket (as shown in Gregory) in in the prior art. The only difference was the combination of the combination with the screw anchor (as shown in Fuller) to ªold elementsº into a single device by mounting them on a single underpin unstable foundations. chassis. The Court found that the operation of the heater was in no way dependent on the operation of the other equipment, and Example 3: that a separate heater could also be used in conjunction with a standard paving machine to achieve the same results. The Court The case of In re Omeprazole Patent Litigation, 536 F.3d 1361, concluded that ª[t]he convenience of putting the burner together 87 USPQ2d 1865 (Fed. Cir. 2008), is one in which the claims with the other elements in one machine, though perhaps a matter in question were found to be nonobvious in the context of an of great convenience, did not produce a `new' or `different argument to combine prior art elements. The invention involved function'º and that to those skilled in the art the use of the old applying enteric coatings to a drug in pill form for the purpose elements in combination would have been obvious. Id. at 60, of ensuring that the drug did not disintegrate before reaching 163 USPQ at 674. its intended site of action. The drug at issue was omeprazole, the generic name for gastric acid inhibitor marketed as Prilosec®. The claimed formulation included two layers of Note that combining known prior art elements is not suf®cient coatings over the active ingredient. to render the claimed invention obvious if the results would not have been predictable to one of ordinary skill in the art. United States v. Adams, 383 U.S. 39, 51-52, 148 USPQ 479, 483-84 The district court found that Astra's patent in suit was infringed (1966). In Adams, the claimed invention was to a battery with by defendants Apotex and Impax. The district court rejected one magnesium electrode and one cuprous chloride electrode Apotex's defense that the patents were invalid for obviousness. that could be stored dry and activated by the addition of plain Apotex had argued that the claimed invention was obvious water or salt water. Although magnesium and cuprous chloride because coated omeprazole tablets were known from a prior art were individually known battery components, the Court reference, and because secondary subcoatings in pharmaceutical concluded that the claimed battery was nonobvious. The Court preparations generally were also known. There was no evidence stated that ª[d]espite the fact that each of the elements of the of unpredictability associated with applying two different enteric Adams battery was well known in the prior art, to combine them coatings to omeprazole. However, Astra's reason for applying as did Adams required that a person reasonably skilled in the an intervening subcoating between the prior art coating and prior art must ignoreº the teaching away of the prior art that omeprazole had been that the prior art coating was actually such batteries were impractical and that water-activated batteries interacting with omeprazole, thereby contributing to undesirable were successful only when combined with electrolytes degradation of the active ingredient. This degradation of detrimental to the use of magnesium electrodes. Id. at 42-43, omeprazole by interaction with the prior art coating had not 50-52, 148 USPQ at 480, 483. ª[w]hen the prior art teaches been recognized in the prior art. Therefore, the district court away from combining certain known elements, discovery of reasoned that based on the evidence available, a person of successful means of combining them is more likely to be ordinary skill in the art would have had no reason to include a nonobvious.º KSR, 550 U.S. at 416, 82 USPQ2d at 1395. subcoating in an omeprazole pill formulation.

Example 2: The Federal Circuit af®rmed the district court's decision that the claimed invention was not obvious. Even though subcoatings The claimed invention in Ruiz v. AB Chance Co., 357 F.3d for enteric drug formulation were known, and there was no 1270, 69 USPQ2d 1686 (Fed. Cir. 2004) was directed to a evidence of undue technical hurdles or lack of a reasonable system which employs a screw anchor for underpinning existing expectation of success, the formulation was nevertheless not foundations and a metal bracket to transfer the building load obvious because the ¯aws in the prior art formulation that had onto the screw anchor. The prior art (Fuller) used screw anchors prompted the modi®cation had not been recognized. Thus there for underpinning existing structural foundations. Fuller used a would have been no reason to modify the initial formulation, concrete haunch to transfer the load of the foundation to the even though the modi®cation could have been done. Moreover, screw anchor. The prior art (Gregory) used a push pier for a person of skill in the art likely would have chosen a different underpinning existing structural foundations. Gregory taught a modi®cation even if he or she had recognized the problem. method of transferring load using a bracket, speci®cally: a metal bracket transfers the foundation load to the push pier. The pier is driven into the ground to support the load. Neither reference

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Of®ce personnel should note that in this case the modi®cation The Federal Circuit disagreed. The Federal Circuit stated that of the prior art that had been presented as an argument for the prior art did not teach foam heel straps, or that a foam heel obviousness was an extra process step that added an additional strap should be placed in contact with a foam base. The Federal component to a known, successfully marketed formulation. The Circuit pointed out that the prior art actually counseled against proposed modi®cation thus amounted to extra work and greater using foam as a material for the heel strap of a shoe. expense for no apparent reason. This is not the same as combining known prior art elements A and B when each would have been expected to contribute its own known properties to The record shows that the prior art would actually the ®nal product. In the Omeprazole case, in view of the discourage and teach away from the use of foam straps. expectations of those of ordinary skill in the art, adding the An ordinary artisan in this ®eld would not add a foam subcoating would not have been expected to confer any strap to the foam Aqua Clog because foam was likely to particular desirable property on the ®nal product. Rather, the stretch and deform, in addition to causing discomfort for ®nal product obtained according to the proposed modi®cations a wearer. The prior art depicts foam as unsuitable for would merely have been expected to have the same functional straps. properties as the prior art product. Id. at 1309, 93 USPQ2d at 1787-88. The Omeprazole case can also be analyzed in view of the discovery of a previously unknown problem by the patentee. If The Federal Circuit continued, stating that even if ± contrary to the adverse interaction between active agent and coating had fact ± the claimed invention had been a combination of elements been known, it might well have been obvious to use a that were known in the prior art, the claims still would have subcoating. However, since the problem had not been previously been nonobvious. There was testimony in the record that the known, there would have been no reason to incur additional loose ®t of the heel strap made the shoe more comfortable for time and expense to add another layer, even though the addition the wearer than prior art shoes in which the heel strap was would have been technologically possible. This is true because constantly in contact with the wearer's foot. In the claimed the prior art of record failed to mention any stability problem, footwear, the foam heel strap contacted the wearer's foot only despite the acknowledgment during testimony at trial that there when needed to help reposition the foot properly in the shoe, was a known theoretical reason that omeprazole might be subject thus reducing wearer discomfort that could arise from constant to degradation in the presence of the known coating material. contact. This desirable feature was a result of the friction between the base section and the strap that kept the strap in place Example 4: behind the Achilles portion of the wearer's foot. The Federal Circuit pointed out that this combination ªyielded more than The case of Crocs, Inc. v. U.S. Int©l Trade Comm©n, 598 F.3d predictable results.º Id. at 1310, 93 USPQ2d at 1788. Aguerre 1294, 93 USPQ 1777 (Fed. Cir. 2010), is a decision in which had taught that friction between the base section and the strap the claimed foam footwear was held by the Federal Circuit to was a problem rather than an advantage, and had suggested the be nonobvious over a combination of prior art references. use of nylon washers to reduce friction. Thus the Federal Circuit stated that even if all elements of the claimed invention had The claims involved in the obviousness issue were from Crocs' been taught by the prior art, the claims would not have been U.S. Patent No. 6,993,858, and were drawn to footwear in which obvious because the combination yielded more than predictable a one-piece molded foam base section formed the top of the results. shoe (the upper) and the sole. A strap also made of foam was attached to the foot opening of the upper, such that the strap The Federal Circuit's discussion in Crocs serves as a reminder could provide support to the Achilles portion of the wearer's to Of®ce personnel that merely pointing to the presence of all foot. The strap was attached via connectors that allowed it to claim elements in the prior art is not a complete statement of a be in contact with the base section, and to pivot relative to the rejection for obviousness. In accordance with MPEP § 2143, base section. Because both the base portion and the strap were subsection I.A.(3), a proper rejection based on the rationale that made of foam, friction between the strap and the base section the claimed invention is a combination of prior art elements also allowed the strap to maintain its position after pivoting. In other includes a ®nding that results ¯owing from the combination words, the foam strap did not fall under the force of gravity to would have been predictable to a person of ordinary skill in the a position adjacent to the heel of the base section. art. MPEP § 2143, subsection I.A.(3). If results would not have been predictable, Of®ce personnel should not enter an The International Trade Commission (ITC) determined that the obviousness rejection using the combination of prior art elements claims were obvious over the combination of two pieces of prior rationale, and should withdraw such a rejection if it has been art. The ®rst was the Aqua Clog, which was a shoe that made. corresponded to the base section of the footwear of the `858 patent. The second was the Aguerre patent, which taught heel Example 5: straps made of elastic or another ¯exible material. In the ITC's view, the claimed invention was obvious because the prior art Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, Aqua Clog differed from the claimed invention only as to the 89 USPQ2d 1535 (Fed. Cir. 2008), involved a segmented and presence of the strap, and a suitable strap was taught by Aguerre. mechanized cover for trucks, swimming pools, or other structures. The claim was found to be obvious over the prior art applied.

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A ®rst prior art reference taught that a reason for making a When considering the question of obviousness, Of®ce personnel segmented cover was ease of repair, in that a single damaged should keep in mind the capabilities of a person of ordinary segment could be readily removed and replaced when necessary. skill. In Ecolab, the Federal Circuit stated: A second prior art reference taught the advantages of a mechanized cover for ease of opening. The Federal Circuit noted that the segmentation aspect of the ®rst reference and the Ecolab's expert admitted that one skilled in the art would mechanization function of the second perform in the same way know how to adjust application parameters to determine after combination as they had before. The Federal Circuit further the optimum parameters for a particular solution. The observed that a person of ordinary skill in the art would have question then is whether it would have been obvious to expected that adding replaceable segments as taught by the ®rst combine the high pressure parameter disclosed in the reference to the mechanized cover of the other would result in Bender patent with the PAA methods disclosed in FMC's a cover that maintained the advantageous properties of both of '676 patent. The answer is yes. Id. the prior art covers. If optimization of the application parameters had not been within Thus, the Sundance case points out that a hallmark of a proper the level of ordinary skill in the art, the outcome of the Ecolab obviousness rejection based on combining known prior art case may well have been different. elements is that one of ordinary skill in the art would reasonably have expected the elements to maintain their respective Example 7: properties or functions after they have been combined. In the case of Wyers v. Master Lock Co., 616 F.3d 1231, 95 Example 6: USPQ2d 1525 (Fed. Cir. 2010), the Federal Circuit held that the claimed barbell-shaped hitch pin locks used to secure trailers In the case of Ecolab, Inc. v. FMC Corp., 569 F.3d 1335, 91 to vehicles were obvious. USPQ2d 1225 (Fed Cir. 2009), an ªapparent reason to combineº in conjunction with the technical ability to optimize led to the The court discussed two different sets of claims in Wyers, both conclusion that the claimed invention would have been obvious. drawn to improvements over the prior art hitch pin locks. The ®rst improvement was a removable sleeve that could be placed The invention in question was a method of treating meat to over the shank of the hitch pin lock so that the same lock could reduce the incidence of pathogens, by spraying the meat with be used with towing apertures of varying sizes. The second an antibacterial solution under speci®ed conditions. The parties improvement was an external ¯at ¯ange seal adapted to protect did not dispute that a single prior art reference had taught all of the internal lock mechanism from contaminants. Wyers had the elements of the claimed invention, except for the pressure admitted that each of several prior art references taught every limitation of ªat least 50 psi.º element of the claimed inventions except for the removable sleeve and the external covering. Master Lock had argued that these references, in combination with additional references FMC had argued at the district court that the claimed invention teaching the missing elements, would have rendered the claims would have been obvious in view of the ®rst prior art reference obvious. The court ®rst addressed the question of whether the mentioned above in view of a second reference that had taught additional references relied on by Master Lock were analogous the advantages of spray-treating at pressures of 20 to 150 psi prior art. As to the reference teaching the sleeve improvement, when treating meat with a different antibacterial agent. The the court concluded that it dealt speci®cally with using a vehicle district court did not ®nd FMC's argument to be convincing, to tow a trailer, and was therefore in the same ®eld of endeavor and denied the motion for judgment as a matter of law that the as Wyers' sleeve improvement. The reference teaching the claim was obvious. sealing improvement dealt with a padlock rather than a lock for a tow hitch. The court noted that Wyers' speci®cation had Disagreeing with the district court, the Federal Circuit stated characterized the claimed invention as being in the ®eld of that ªthere was an apparent reason to combine these known locking devices, thus at least suggesting that the sealed padlock elements ± namely to increase contact between the [antibacterial reference was in the same ®eld of endeavor. However, the court solution] and the bacteria on the meat surface and to use the also observed that even if sealed padlocks were not in the same pressure to wash additional bacteria off the meat surface.º Id. ®eld of endeavor, they were nevertheless reasonably pertinent at 1350, 91 USPQ2d at 1234. The Federal Circuit explained that to the problem of avoiding contamination of a locking because the second reference had taught ªusing high pressure mechanism for tow hitches. The court explained that the to improve the effectiveness of an antimicrobial solution when Supreme Court's decision in KSR ªdirects [it] to construe the sprayed onto meat, and because an ordinarily skilled artisan scope of analogous art broadly.º Id. at 1238, 95 USPQ2d at would have recognized the reasons for applying [the claimed 1530. For these reasons, the court found that Master Lock's antibacterial solution] using high pressure and would have asserted references were analogous prior art, and therefore known how to do so, Ecolab's claims combining high pressure relevant to the obviousness inquiry. with other limitations disclosed in FMC's patent are invalid as obvious.º Id. The court then turned to the question of whether there would have been adequate motivation to combine the prior art elements as had been urged by Master Lock. The court recalled the Graham inquiries, and also emphasized the ªexpansive and

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Example 8: ¯exibleº post-KSR approach to obviousness that must not ªdeny fact®nders recourse to common sense.º Id. at 1238, 95 USPQ2d The claim in DePuy Spine, Inc. v. Medtronic Sofamor Danek, at 1530-31. (quoting KSR, 550 U.S. at 415, 421, 82 USPQ2d Inc., 567 F.3d 1314, 90 USPQ2d 1865 (Fed. Cir. 2009), was at 1395, 1397). The court stated: directed to a polyaxial pedicle screw used in spinal surgeries that included a compression member for pressing a screw head KSR and our later cases establish that the legal against a receiver member. A prior art reference (Puno) disclosed determination of obviousness may include recourse to all of the elements of the claim except for the compression logic, judgment, and common sense, in lieu of expert member. Instead, the screw head in Puno was separated from testimony. . . . Thus, in appropriate cases, the ultimate the receiver member to achieve a shock absorber effect, allowing inference as to the existence of a motivation to combine some motion between receiver member and the vertebrae. The references may boil down to a question of ªcommon missing compression member was readily found in another prior sense,º appropriate for resolution on summary judgment art reference (Anderson), which disclosed an external fracture or JMOL. immobilization splint for immobilizing long bones with a swivel clamp capable of polyaxial movement until rigidly secured by a compression member. It was asserted during trial that a person Id. at 1240, 82 USPQ2d at 1531 (citing Perfect Web Techs., of ordinary skill would have recognized that the addition of Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1330, 92 USPQ2d, 1849, Anderson's compression member to Puno's device would have 1854 (Fed. Cir. 2009); Ball Aerosol, 555 F.3d at 993, 89 achieved a rigidly locked polyaxial pedicle screw covered by USPQ2d 1870, 1875 (Fed. Cir. 2009)). the claim.

After reviewing these principles, the court proceeded to explain In conducting its analysis, the Federal Circuit noted that the why adequate motivation to combine had been established in ªpredictable resultº discussed in KSR refers not only to the this case. With regard to the sleeve improvement, it pointed out expectation that prior art elements are capable of being that the need for different sizes of hitch pins was well known physically combined, but also that the combination would have in the art, and that this was a known source of inconvenience worked for its intended purpose. In this case, it was successfully and expense for users. The court also mentioned the marketplace argued that Puno ªteaches awayº from a rigid screw because aspect of the issue, noting that space on store shelves was at a Puno warned that rigidity increases the likelihood that the screw premium, and that removable sleeves addressed this economic will fail within the human body, rendering the device inoperative concern. As to the sealing improvement, the court pointed out for its intended purpose. In fact, the reference did not merely that both internal and external seals were well-known means to express a general preference for pedicle screws having a ªshock protect locks from contaminants. The court concluded that the absorberº effect, but rather expressed concern for failure and constituent elements were being employed in accordance with stated that the shock absorber feature ªdecrease[s] the chance their recognized functions, and would have predictably retained of failure of the screw of the bone-screw interfaceº because ªit their respective functions when combined as suggested by prevent[s] direct transfer of load from the rod to the bone-screw Master Lock. The court cited In re O'Farrell, 853 F.2d 894, interface.º Thus, the alleged reason to combine the prior art 904 (Fed. Cir. 1988) for the proposition that a reasonable elements of Puno and AndersonÐincreasing the rigidity of the expectation of success is a requirement for a proper screwÐran contrary to the prior art that taught that increasing determination of obviousness. rigidity would result in a greater likelihood of failure. In view of this teaching and the backdrop of collective teachings of the Of®ce personnel should note that although the Federal Circuit prior art, the Federal Circuit determined that Puno teaches away invoked the idea of common sense in support of a conclusion from the proposed combination such that a person of ordinary of obviousness, it did not end its explanation there. Rather, the skill would have been deterred from combining the references court explained why a person of ordinary skill in the art at the as proposed. Secondary considerations evaluated by the Federal time of the invention, in view of the facts relevant to the case, Circuit relating to failure by others and copying also supported would have found the claimed inventions to have been obvious. the view that the combination would not have been obvious at The key to supporting any rejection under 35 U.S.C. 103 is the the time of the invention. clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted B. Simple Substitution of One Known Element for that the analysis supporting a rejection under 35 U.S.C. 103 Another To Obtain Predictable Results should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that ª[R]ejections on obviousness cannot be sustained by mere To reject a claim based on this rationale, Of®ce conclusory statements; instead, there must be some articulated personnel must resolve the Graham factual reasoning with some rational underpinning to support the legal inquiries. Then, Of®ce personnel must articulate the conclusion of obviousness.º See MPEP § 2141, subsection III. Of®ce personnel should continue to provide a reasoned following: explanation for every obviousness rejection. (1) a ®nding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some

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components (step, element, etc.) with other to protein production, because one of ordinary skill in the art components; would have been able to carry out such a substitution, and the results were reasonably predictable. (2) a ®nding that the substituted components and their functions were known in the art; In response to applicant's argument that there had been (3) a ®nding that one of ordinary skill in the art signi®cant unpredictability in the ®eld of molecular biology at the time of the invention, the court stated that the level of skill could have substituted one known element for was quite high and that the teachings of Polisky, even taken another, and the results of the substitution would alone, contained detailed enabling methodology and included have been predictable; and the suggestion that the modi®cation would be successful for synthesis of proteins. (4) whatever additional ®ndings based on the Graham factual inquiries may be necessary, in view This is not a situation where the rejection is a statement that it of the facts of the case under consideration, to would have been ªobvious to tryº without more. Here there was explain a conclusion of obviousness. a reasonable expectation of success. ªObviousness does not require absolute predictability of success.º Id. at 903, 7 USPQ2d The rationale to support a conclusion that the claim at 1681. would have been obvious is that the substitution of Example 3: one known element for another yields predictable results to one of ordinary skill in the art. If any of The fact pattern in Ruiz v. AB Chance Co., 357 F.3d 1270, 69 these ®ndings cannot be made, then this rationale USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2 cannot be used to support a conclusion that the claim in subsection I.A., above. would have been obvious to one of ordinary skill in the art. The prior art showed differing load-bearing members and differing means of attaching the foundation to the member. Therefore, it would have been obvious to one of ordinary skill Example 1: in the art to substitute the metal bracket taught in Gregory for The claimed invention in In re Fout, 675 F.2d 297, 213 USPQ Fuller's concrete haunch for the predictable result of transferring 532 (CCPA 1982) was directed to a method for decaffeinating the load. coffee or tea. The prior art (Pagliaro) method produced a Example 4: decaffeinated vegetable material and trapped the caffeine in a fatty material (such as oil). The caffeine was then removed from The claimed invention in Ex parte Smith, 83 USPQ2d 1509 the fatty material by an aqueous extraction process. Applicant (Bd. Pat. App. & Int. 2007), was a pocket insert for a bound (Fout) substituted an evaporative distillation step for the aqueous book made by gluing a base sheet and a pocket sheet of paper extraction step. The prior art (Waterman) suspended coffee in together to form a continuous two-ply seam de®ning a closed oil and then directly distilled the caffeine through the oil. The pocket. The prior art (Wyant) disclosed at least one pocket court found that ª[b]ecause both Pagliaro and Waterman teach formed by folding a single sheet and securing the folder portions a method for separating caffeine from oil, it would have been along the inside margins using any convenient bonding method. prima facie obvious to substitute one method for the other. The prior art (Wyant) did not disclose bonding the sheets to Express suggestion to substitute one equivalent for another need form a continuous two-ply seam. The prior art (Dick) disclosed not be present to render such substitution obvious.º Id. at 301, a pocket that is made by stitching or otherwise securing two 213 USPQ at 536. sheets along three of its four edges to de®ne a closed pocket with an opening along its fourth edge. Example 2:

The claimed invention in In re O'Farrell, 853 F.2d 894, In considering the teachings of Wyant and Dick, the Board 7 USPQ2d 1673 (Fed. Cir. 1988) was directed to a method for ªfound that (1) each of the claimed elements is found within the synthesizing a protein in a transformed bacterial host species scope and content of the prior art; (2) one of ordinary skill in by substituting a heterologous gene for a gene native to the host the art could have combined the elements as claimed by methods species. Generally speaking, protein synthesis in vivo follows known at the time the invention was made; and (3) one of a path from DNA to mRNA. Although the prior art Polisky ordinary skill in the art would have recognized at the time the article (authored by two of the three inventors of the application) invention was made that the capabilities or functions of the had explicitly suggested employing the method described for combination were predictable.º Citing KSR, the Board protein synthesis, the inserted heterologous gene exempli®ed concluded that ª[t]he substitution of the continuous, two-ply in the article was one that normally did not proceed all the way seam of Dick for the folded seam of Wyant thus is no more than to the protein production step, but instead terminated with the the simple substitution of one known element for another or the mRNA. A second reference to Bahl had described a general mere application of a known technique to a piece of prior art method of inserting chemically synthesized DNA into a plasmid. ready for improvement. Thus, it would have been obvious to one of ordinary skill in the art to replace the prior art gene with another gene known to lead

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Example 5: folding mechanism,º and because ªnothing about ICON's The claimed invention in In re ICON Health & Fitness, Inc., folding mechanism requires any particular focus on treadmills,º 496 F.3d 1374, 83 USPQ2d 1746 (Fed. Cir. 2007), was directed Id. at 1378, 1380, 83 USPQ2d at 1749-50. to a treadmill with a folding tread base that swivels into an upright storage position, including a gas spring connected ICON is also informative as to the relationship between the between the tread base and the upright structure to assist in problem to be solved and existence of a reason to combine. stably retaining the tread base in the storage position. On ªIndeed, while perhaps not dispositive of the issue, the ®nding reexamination, the examiner rejected the claims as obvious that Teague, by addressing a similar problem, provides based on a combination of references including an advertisement analogous art to ICON's application goes a long way towards (Damark) for a folding treadmill demonstrating all of the claim demonstrating a reason to combine the two references. Because elements other than the gas spring, and a patent (Teague) with ICON's broad claims read on embodiments addressing that a gas spring. Teague was directed to a bed that folds into a problem as described by Teague, the prior art here indicates a cabinet using a novel dual-action spring that reverses force as reason to incorporate its teachings.º Id. at 1380-81, 83 USPQ2d the mechanism passes a neutral position, rather than a at 1751. single-action spring that would provide a force pushing the bed closed at all times. The dual-action spring reduced the force The Federal Circuit's discussion in ICON also makes clear that required to open the bed from the closed position, while reducing if the reference does not teach that a combination is undesirable, the force required to lift the bed from the open position. then it cannot be said to teach away. An assessment of whether a combination would render the device inoperable must not The Federal Circuit addressed the propriety of making the ªignore the modi®cations that one skilled in the art would make combination since Teague was in a different ®eld than the to a device borrowed from the prior art.º Id. at 1382, 83 application. Teague was found to be reasonably pertinent to the USPQ2d at 1752. problem addressed in the application because the folding mechanism did not require any particular focus on treadmills, Example 6: but rather generally addressed problems of supporting the weight of such a mechanism and providing a stable resting position. Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 86 USPQ2d 1110 (Fed. Cir. 2008), involved a stationary pest control device for electrocution of pests such as rats and gophers, in which the The court also considered whether one skilled in the art would device is set in an area where the pest is likely to encounter it. have been led to combine the teachings of Damark and Teague. The only difference between the claimed device and the prior Appellant argued that Teague teaches away from the invention art stationary pest control device was that the claimed device because it directs one skilled in the art not to use single-action employed a resistive electrical switch, while the prior art device springs and does not satisfy the claim limitations as the used a mechanical pressure switch. A resistive electrical switch dual-action springs would render the invention inoperable. The was taught in two prior art patents, in the contexts of a hand-held Federal Circuit considered these arguments and found that, while pest control device and a cattle prod. Teague at most teaches away from using single-action springs to decrease the opening force, it actually instructed that single-action springs provide the result desired by the inventors, In determining that the claimed invention was obvious, the which was to increase the opening force provided by gravity. Federal Circuit noted that ª[t]he asserted claims simply substitute As to inoperability, the claims were not limited to single-action a resistive electrical switch for the mechanical pressure switchº springs and were so broad as to encompass anything that assists employed in the prior art device. Id. at 1344, 86 USPQ2d at in stably retaining the tread base, which is the function that 1115. In this case, the prior art concerning the hand-held devices Teague accomplished. Additionally, the fact that the revealed that the function of the substituted resistive electrical counterweight mechanism from Teague used a large spring, switch was well known and predictable, and that it could be which appellant argued would overpower the treadmill used in a pest control device. According to the Federal Circuit, mechanism, ignores the modi®cations that one skilled in the art the references that taught the hand-held devices showed that would make to a device borrowed from the prior art. One skilled ªthe use of an animal body as a resistive switch to complete a in the art would size the components from Teague appropriately circuit for the generation of an electric charge was already well for the application. known in the prior art.º Id. Finally, the Federal Circuit noted that the problem solved by using the resistive electrical switch in the prior art hand-held devices ± malfunction of mechanical ICON is another useful example for understanding the scope switches due to dirt and dampness ± also pertained to the prior of analogous art. The art applied concerned retaining art stationary pest control device. mechanisms for folding beds, not treadmills. When determining whether a reference may properly be applied to an invention in a different ®eld of endeavor, it is necessary to consider the The Federal Circuit recognized Agrizap as ªa textbook case of problem to be solved. It is certainly possible that a reference when the asserted claims involve a combination of familiar may be drawn in such a way that its usefulness as a teaching is elements according to known methods that does no more than narrowly restricted. However, in ICON, the problem to be yield predictable results.º Id. Agrizap exempli®es a strong case solved was not limited to the teaching of the ªtreadmillº concept. of obviousness based on simple substitution that was not The Teague reference was analogous art because ªTeague and overcome by the objective evidence of nonobviousness offered. the current application both address the need to stably retain a It also demonstrates that analogous art is not limited to the ®eld

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of applicant's endeavor, in that one of the references that used The record showed that the presence of multiple S stereocenters an animal body as a resistive switch to complete a circuit for in drugs similar to ramipril was known to be associated with the generation of an electric charge was not in the ®eld of pest enhanced therapeutic ef®cacy. For example, when all of the control. stereocenters were in the S form in the related drug enalapril (SSS enalapril) as compared with only two stereocenters in the Example 7: S form (SSR enalapril), the therapeutic potency was 700 times as great. There was also evidence to indicate that conventional The invention at issue in Muniauction, Inc. v. Thomson Corp., methods could be used to separate the various stereoisomers of 532 F.3d 1318, 87 USPQ2d1350 (Fed. Cir. 2008), was a method ramipril. for auctioning municipal bonds over the Internet. A municipality could offer a package of bond instruments of varying principal amounts and maturity dates, and an interested buyer would then The district court saw the issue as a close case, because, in its submit a bid comprising a price and interest rate for each view, there was no clear motivation in the prior art to isolate maturity date. It was also possible for the interested buyer to 5(S) ramipril. However, the Federal Circuit disagreed, and found bid on a portion of the offering. The claimed invention that the claims would have been obvious. The Federal Circuit considered all of the noted parameters to determine the best bid. cautioned that requiring such a clearly stated motivation in the It operated on conventional Web browsers and allowed prior art to isolate 5(S) ramipril ran counter to the Supreme participants to monitor the course of the auction. Court's decision in KSR, and the court stated:

The only difference between the prior art bidding system and Requiring an explicit teaching to purify the 5(S) the claimed invention was the use of a conventional Web stereoisomer from a mixture in which it is the active browser. At trial, the district court had determined that ingredient is precisely the sort of rigid application of the Muniauction's claims were not obvious. Thomson argued that TSM test that was criticized in KSR. the claimed invention amounted to incorporating a Web browser into a prior art auction system, and was therefore obvious in Id. at 1301, 84 USPQ2d at 1204. The Aventis court also relied light of KSR. Muniauction rebutted the argument by offering on the settled principle that in chemical cases, structural evidence of skepticism by experts, copying, praise, and similarity can provide the necessary reason to modify prior art commercial success. Although the district court found the teachings. The Federal Circuit also addressed the kind of evidence to be persuasive of nonobviousness, the Federal Circuit teaching that would be suf®cient in the absence of an explicitly disagreed. It noted that a nexus between the claimed invention stated prior art-based motivation, explaining that an expectation and the proffered evidence was lacking because the evidence of similar properties in light of the prior art can be suf®cient, was not coextensive with the claims at issue. For this reason, even without an explicit teaching that the compound will have the Federal Circuit determined that Muniauction's evidence of a particular utility. secondary considerations was not entitled to substantial weight.

In the chemical arts, the cases involving so-called ªlead The Federal Circuit analogized this case to Leapfrog Enters., compoundsº form an important subgroup of the obviousness Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 82 USPQ2d 1687 cases that are based on substitution. The Federal Circuit has had (Fed. Cir. 2007). The Leapfrog case involved a determination a number of opportunities since the KSR decision to discuss of obviousness based on application of modern electronics to a the circumstances under which it would have been obvious to prior art mechanical children's learning device. In Leapfrog, modify a known compound to arrive at a claimed compound. the court noted that market pressures would have prompted a The following cases explore the selection of a lead compound, person of ordinary skill to use modern electronics in the prior the need to provide a reason for any proposed modi®cation, and art device. Similarly in Muniauction, market pressures would the predictability of the result. have prompted a person of ordinary skill to use a conventional Web browser in a method of auctioning municipal bonds. Example 9:

Example 8: Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 87 USPQ2d 1452 (Fed. Cir. 2008), concerns the pharmaceutical In Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, compound rabeprazole. Rabeprazole is a proton pump inhibitor 84 USPQ2d 1197 (Fed. Cir. 2007), the claims were drawn to for treating stomach ulcers and related disorders. The Federal the 5(S) stereoisomer of the blood pressure drug ramipril in Circuit af®rmed the district court's summary judgment of stereochemically pure form, and to compositions and methods nonobviousness, stating that no reason had been advanced to requiring 5(S) ramipril. The 5(S) stereoisomer is one in which modify the prior art compound in a way that would destroy an all ®ve stereocenters in the ramipril molecule are in the S rather advantageous property. than the R con®guration. A mixture of various stereoisomers including 5(S) ramipril had been taught by the prior art. The question before the court was whether the puri®ed single Co-defendant Teva based its obviousness argument on the stereoisomer would have been obvious over the known mixture structural similarity between rabeprazole and lansoprazole. The of stereoisomers. compounds were recognized as sharing a common core, and the Federal Circuit characterized lansoprazole as a ªlead compound.º The prior art compound lansoprazole was useful for the same indications as rabeprazole, and differed from rabeprazole only

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in that lansoprazole has a tri¯uoroethoxy substituent at the The Federal Circuit in Eisai makes it clear that from the 4-position of the pyridine ring, while rabeprazole has a perspective of the law of obviousness, any known compound methoxypropoxy substituent. The tri¯uoro substituent of might possibly serve as a lead compound: ªObviousness based lansoprazole was known to be a bene®cial feature because it on structural similarity thus can be proved by identi®cation of conferred lipophilicity to the compound. The ability of a person some motivation that would have led one of ordinary skill in of ordinary skill to carry out the modi®cation to introduce the the art to select and then modify a known compound (i.e. a lead methoxypropoxy substituent, and the predictability of the result compound) in a particular way to achieve the claimed were not addressed. compound.º Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455. Thus, Of®ce personnel should recognize that a proper obviousness Despite the signi®cant similarity between the structures, the rejection of a claimed compound that is useful as a drug might Federal Circuit did not ®nd any reason to modify the lead be made beginning with an inactive compound, if, for example, compound. According to the Federal Circuit: the reasons for modifying a prior art compound to arrive at the claimed compound have nothing to do with pharmaceutical activity. The inactive compound would not be considered to be Obviousness based on structural similarity thus can be a lead compound by pharmaceutical chemists, but could proved by identi®cation of some motivation that would potentially be used as such when considering obviousness. Of®ce have led one of ordinary skill in the art to select and then personnel might also base an obviousness rejection on a known modify a known compound (i.e. a lead compound) in a compound that pharmaceutical chemists would not select as a particular way to achieve the claimed compound. . . . In lead compound due to expense, handling issues, or other business keeping with the ¯exible nature of the obviousness considerations. However, there must be some reason for starting inquiry, the requisite motivation can come from any with that lead compound other than the mere fact that the ªlead number of sources and need not necessarily be explicit in compoundº merely exists. See Altana Pharma AG v. Teva the art. Rather ªit is suf®cient to show that the claimed Pharm. USA, Inc., 566 F.3d 999, 1007, 91 USPQ2d 1018, 1024 and prior art compounds possess a `suf®ciently close (Fed. Cir. 2009) (holding that there must be some reason ªto relationship . . . to create an expectation,' in light of the select and modify a known compoundº); Ortho-McNeil Pharm., totality of the prior art, that the new compound will have Inc. v. Mylan Labs, Inc., 520 F.3d 1358, 1364, 86 USPQ2d 1196, `similar properties' to the old.º Id. at 1357, 87 USPQ2d 1201 (Fed. Cir. 2008). at 1455. (citations omitted) Example 10:

The prior art taught that introducing a ¯uorinated substituent The claimed chemical compound was also found to be was known to increase lipophilicity, so a skilled artisan would nonobvious in Procter & Gamble Co. v. Teva Pharm. USA, have expected that replacing the tri¯uoroethoxy substituent with Inc., 566 F.3d 989, 90 USPQ2d 1947 (Fed. Cir. 2009). The a methoxypropoxy substituent would have reduced the compound at issue was risedronate ± the active ingredient of lipophilicity of the compound. Thus, the prior art created the Procter & Gamble's osteoporosis drug Actonel®. Risedronate expectation that rabeprazole would be less useful than is an example of a bisphosphonate, which is a class of lansoprazole as a drug for treating stomach ulcers and related compounds known to inhibit bone resorption. disorders because the proposed modi®cation would have destroyed an advantageous property of the prior art compound. The compound was not obvious as argued by Teva because, When Procter & Gamble sued Teva for infringement, Teva upon consideration of all of the facts of the case, a person of defended by arguing invalidity for obviousness over one of ordinary skill in the art at the time of the invention would not Procter & Gamble's earlier patents. The prior art patent did not have had a reason to modify lansoprazole so as to form teach risedronate, but instead taught thirty-six other similar rabeprazole. compounds including 2-pyr EHDP that were potentially useful with regard to osteoporosis. Teva argued obviousness on the basis of structural similarity to 2-pyr EHDP, which is a positional Of®ce personnel are cautioned that the term ªlead compoundº isomer of risedronate. in a particular opinion can have a contextual meaning that may vary from the way a pharmaceutical chemist might use the term. In the ®eld of pharmaceutical chemistry, the term ªlead The district court found no reason to select 2-pyr EHDP as a compoundº has been de®ned variously as ªa chemical compound lead compound in light of the unpredictable nature of the art, that has pharmacological or biological activity and whose and no reason to modify it so as to obtain risedronate. In chemical structure is used as a starting point for chemical addition, there were unexpected results as to potency and modi®cations in order to improve potency, selectivity, or toxicity. Therefore the district court found that Teva had not pharmacokinetic parameters;º ª[a] compound that exhibits made a prima facie case, and even if it had, it was rebutted by pharmacological properties which suggest its development;º evidence of unexpected results. and ªa potential drug being tested for safety and ef®cacy.º See, e.g., http://en.wikipedia.org/wiki/Lead_compound, accessed The Federal Circuit af®rmed the district court's decision. The January 13, 2010; www.combichemistry.com/glossary_k.html, Federal Circuit did not deem it necessary in this case to consider accessed January 13, 2010; and the question of whether 2-pyr EHDP had been appropriately www.buildingbiotechnology.com/glossary4.php, accessed selected as a lead compound. Rather, the Federal Circuit January 13, 2010. reasoned that, if 2-pyr EHDP is presumed to be an appropriate

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lead compound, there must be both a reason to modify it so as found to have been obvious if there would have been a reason to make risedronate and a reasonable expectation of success. to link the two, if one of ordinary skill would have known how Here, there was no evidence that the necessary modi®cations to do so, and if the resulting compound would have been the would have been routine, so there would have been no predictable result of the linkage procedure. Thus, Of®ce reasonable expectation of success. personnel should recognize that in certain situations, it may be proper to reject a claimed chemical compound as obvious even Procter & Gamble is also informative in its discussion of the without identifying a single lead compound. treatment of secondary considerations of non-obviousness. Example 11: Although the court found that no prima facie case of obviousness had been presented, it proceeded to analyze Procter The decision reached by the Federal Circuit in Altana Pharma & Gamble's proffered evidence countering the alleged prima AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 91 USPQ2d 1018 facie case in some detail, thus shedding light on the proper (Fed. Cir. 2009), as discussed below, involved a motion for treatment of such evidence. preliminary injunction and did not include a ®nal determination of obviousness. However, the case is instructive as to the issue The Federal Circuit noted in dicta that even if a prima facie of selecting a lead compound. case of obviousness had been established, suf®cient evidence of unexpected results was introduced to rebut such a showing. The technology involved in Altana was the compound At trial, the witnesses consistently testi®ed that the properties pantoprazole, which is the active ingredient in Altana's antiulcer of risedronate were not expected, offering evidence that ® researchers did not predict either the potency or the low dose at drug Protonix . Pantoprazole belongs to a class of compounds which the compound was effective. Tests comparing risedronate known as proton pump inhibitors that are used to treat gastric to a compound in the prior art reference showed that risedronate acid disorders in the stomach. outperformed the other compound by a substantial margin, could be administered in a greater amount without an observable toxic Altana accused Teva of infringement. The district court denied effect, and was not lethal at the same levels as the other Altana's motion for preliminary injunction for failure to establish compound. The weight of the evidence and the credibility of a likelihood of success on the merits, determining that Teva had the witnesses were suf®cient to show unexpected results that demonstrated a substantial question of invalidity for obviousness would have rebutted an obviousness determination. Thus, in light of one of Altana's prior patents. Altana's patent nonobviousness can be shown when a claimed invention is discussed a compound referred to as compound 12, which was shown to have unexpectedly superior properties when compared one of eighteen compounds disclosed. The claimed compound to the prior art. pantoprazole was structurally similar to compound 12. The district court found that one of ordinary skill in the art would The court then addressed the evidence of commercial success have selected compound 12 as a lead compound for of risedronate and the evidence that risedronate met a long felt modi®cation, and the Federal Circuit af®rmed. need. The court pointed out that little weight was to be afforded to the commercial success because the competing product was Obviousness of a chemical compound in view of its structural also assigned to Procter & Gamble. However, the Federal Circuit similarity to a prior art compound may be shown by identifying af®rmed the district court's conclusion that risedronate met a some line of reasoning that would have led one of ordinary skill long-felt, but unsatis®ed need. The court rejected Teva's in the art to select and modify the prior art compound in a contention that because the competing drug was available before particular way to produce the claimed compound. The necessary Actonel7, there was no unmet need that the invention satis®ed. line of reasoning can be drawn from any number of sources and The court emphasized that whether there was a long-felt but need not necessarily be explicitly found in the prior art of record. unsatis®ed need is to be evaluated based on the circumstances The Federal Circuit determined that ample evidence supported as of the ®ling date of the challenged invention ± not as of the the district court's ®nding that compound 12 was a natural date that the invention is brought to market. choice for further development. For example, Altana's prior art patent claimed that its compounds, including compound 12, It should be noted that the lead compound cases do not stand were improvements over the prior art; compound 12 was for the proposition that identi®cation of a single lead compound disclosed as one of the more potent of the eighteen compounds is necessary in every obviousness rejection of a chemical disclosed; the patent examiner had considered the compounds compound. For example, one might envision a suggestion in of Altana's prior art patent to be relevant during the prosecution the prior art to formulate a compound having certain structurally of the patent in suit; and experts had opined that one of ordinary de®ned moieties, or moieties with certain properties. If a person skill in the art would have selected the eighteen compounds to of ordinary skill would have known how to synthesize such a pursue further investigation into their potential as proton pump compound, and the structural and/or functional result could inhibitors. reasonably have been predicted, then a prima facie case of obviousness of the claimed chemical compound might exist In response to Altana's argument that the prior art must point even without identi®cation a particular lead compound. As a to only a single lead compound for further development, the second example, it could be possible to view a claimed Federal Circuit stated that a ªrestrictive view of the lead compound as consisting of two known compounds attached via compound test would present a rigid test similar to the a chemical linker. The claimed compound might properly be teaching-suggestion-motivation test that the Supreme Court

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explicitly rejected in KSR . . . . The district court in this case be used to support a conclusion that the claim would employed a ¯exible approach ± one that was admittedly have been obvious to one of ordinary skill in the art. preliminary ± and found that the defendants had raised a substantial question that one of skill in the art would have used Example 1: the more potent compounds of [Altana's prior art] patent, including compound 12, as a starting point from which to pursue The claimed invention in In re Nilssen, 851 F.2d 1401, 7 further development efforts. That ®nding was not clearly USPQ2d 1500 (Fed. Cir. 1988) was directed to a ªmeans by erroneous.º Id. at 1008, 91 USPQ2d at 1025. which the self-oscillating inverter in a power-line-operated inverter-type ¯uorescent lamp ballast is disabled in case the C. Use of Known Technique To Improve Similar output current from the inverter exceeds some pre-established Devices (Methods, or Products) in the Same Way threshold level for more than a very brief period.º Id. at 1402, 7 USPQ2d at 1501 That is, the current output was monitored, and if the current output exceeded some threshold for a speci®ed To reject a claim based on this rationale, Of®ce short time, an actuation signal was sent and the inverter was personnel must resolve the Graham factual disabled to protect it from damage. inquiries. Then, Of®ce personnel must articulate the following: The prior art (a USSR certi®cate) described a device for protecting an inverter circuit in an undisclosed manner via a control means. The device indicated the high-load condition by (1) a ®nding that the prior art contained a ªbaseº way of the control means, but did not indicate the speci®c device (method, or product) upon which the claimed manner of overload protection. The prior art (Kammiller) invention can be seen as an ªimprovement;º disclosed disabling the inverter in the event of a high-load current condition in order to protect the inverter circuit. That is, (2) a ®nding that the prior art contained a the overload protection was achieved by disabling the inverter ªcomparableº device (method, or product that is not by means of a cutoff switch. the same as the base device) that has been improved in the same way as the claimed invention; The court found ªit would have been obvious to one of ordinary skill in the art to use the threshold signal produced in the USSR (3) a ®nding that one of ordinary skill in the art device to actuate a cutoff switch to render the inverter could have applied the known ªimprovementº inoperative as taught by Kammiller.º Id. at 1403, 7 USPQ2d technique in the same way to the ªbaseº device at 1502. That is, using the known technique of a cutoff switch (method, or product) and the results would have been for protecting a circuit to provide the protection desired in the inverter circuit of the USSR document would have been obvious predictable to one of ordinary skill in the art; and to one of ordinary skill. (4) whatever additional ®ndings based on the Example 2: Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to The fact pattern in Ruiz v. AB Chance Co., 357 F.3d 1270, 69 explain a conclusion of obviousness. USPQ2d 1686 (Fed. Cir. 2004) is set forth above in Example 2 in subsection I.A. The rationale to support a conclusion that the claim would have been obvious is that a method of The nature of the problem to be solved may lead inventors to enhancing a particular class of devices (methods, or look at references relating to possible solutions to that problem. products) has been made part of the ordinary Id. at 1277, 69 USPQ2d at 1691. Therefore, it would have been obvious to use a metal bracket (as shown in Gregory) with the capabilities of one skilled in the art based upon the screw anchor (as shown in Fuller) to underpin unstable teaching of such improvement in other situations. foundations. One of ordinary skill in the art would have been capable of applying this known method of D. Applying a Known Technique to a Known Device enhancement to a ªbaseº device (method, or product) (Method, or Product) Ready for Improvement To Yield in the prior art and the results would have been Predictable Results predictable to one of ordinary skill in the art. The Supreme Court in KSR noted that if the actual To reject a claim based on this rationale, Of®ce application of the technique would have been beyond personnel must resolve the Graham factual the skill of one of ordinary skill in the art, then using inquiries. Then, Of®ce personnel must articulate the the technique would not have been obvious. KSR, following: 550 U.S. at 417, 82 USPQ2d at 1396. If any of these ®ndings cannot be made, then this rationale cannot

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(1) a ®nding that the prior art contained a ªbaseº for transactions and for posting to the appropriate accounts. device (method, or product) upon which the claimed These systems included generating periodic statements for each invention can be seen as an ªimprovement;º account, such as the monthly statement sent to checking account customers. (2) a ®nding that the prior art contained a known technique that is applicable to the base device IMPROVED SYSTEM - The claimed invention supplemented (method, or product); this system by recording a category code which could be used to track expenditures by category. Again, the category code will (3) a ®nding that one of ordinary skill in the art be a number recorded on the check (or deposit slip) which will would have recognized that applying the known be read, converted into a magnetic ink imprint, and then technique would have yielded predictable results processed in the data system to include the category code. This and resulted in an improved system; and enabled reporting of data by category as opposed to only allowing reporting by account number. (4) whatever additional ®ndings based on the Graham factual inquiries may be necessary, in view KNOWN TECHNIQUE - This is an application of a technique of the facts of the case under consideration, to from the prior art ± the use of account numbers (generally used to track an individual©s total transactions) to solve the problem explain a conclusion of obviousness. of how to track categories of expenditures to more ®nely account The rationale to support a conclusion that the claim for a budget. That is, account numbers (identifying data capable of processing in the automatic data processing system) were would have been obvious is that a particular known used to distinguish between different customers. Furthermore, technique was recognized as part of the ordinary banks have long segregated debits attributable to service charges capabilities of one skilled in the art. One of ordinary within any given separate account and have rendered their skill in the art would have been capable of applying customers subtotals for those charges. Previously, one would have needed to set up separate accounts for each category and this known technique to a known device (method, thus receive separate reports. Supplementing the account or product) that was ready for improvement and the information with additional digits (the category codes) solved results would have been predictable to one of the problem by effectively creating a single account that can be ordinary skill in the art. If any of these ®ndings treated as distinct accounts for tracking and reporting services. cannot be made, then this rationale cannot be used That is, the category code merely allowed what might previously have been separate accounts to be handled as a single account, to support a conclusion that the claim would have but with a number of sub-accounts indicated in the report. been obvious to one of ordinary skill in the art. The basic technique of putting indicia on data to enable standard Example 1: sorting, searching, and reporting yielded no more than the The claimed invention in Dann v. Johnston, 425 U.S. 219, 189 predictable outcome which one of ordinary skill would have USPQ 257 (1976) was directed towards a system (i.e., computer) expected to achieve with this common tool of the trade and was for automatic record keeping of bank checks and deposits. In therefore an obvious expedient. The Court held that ª[t]he gap this system, a customer would put a numerical category code between the prior art and respondent's system is simply not so on each check or deposit slip. The check processing system great as to render the system nonobvious to one reasonably would record these on the check in magnetic ink, just as it does skilled in the art.º Id. at 230, 189 USPQ at 261. for amount and account information. With this system in place, Example 2: the bank can provide statements to customers that are broken down to give subtotals for each category. The claimed system The fact pattern in In re Nilssen, 851 F.2d 1401, 7 USPQ2d also allowed the bank to print reports according to a style 1500 (Fed. Cir. 1988) is set forth above in Example 1 in requested by the customer. As characterized by the Court, subsection C. ª[u]nder respondent's invention, then, a general purpose computer is programmed to provide bank customers with an individualized and categorized breakdown of their transactions The court found ªit would have been obvious to one of ordinary during the period in question.º Id. at 222, 189 USPQ at 259. skill in the art to use the threshold signal produced in the USSR device to actuate a cutoff switch to render the inverter inoperative as taught by Kammiller.º Id. at 1403, 7 USPQ2d BASE SYSTEM - The nature of the use of data processing at 1502. The known technique of using a cutoff switch would equipment and computer software in the banking industry was have predictably resulted in protecting the inverter circuit. that banks routinely did much of the record-keeping Therefore, it would have been within the skill of the ordinary automatically. In routine check processing, the system read any artisan to use a cutoff switch in response to the actuation signal magnetic ink characters identifying the account and routing. to protect the inverter. The system also read the amount of the check and then printed that value in a designated area of the check. The check was then sent through a further data processing step which used the magnetic ink information to generate the appropriate records

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E. ªObvious To Tryº ± Choosing From a Finite will survive scrutiny under an obvious to try Number of Identi®ed, Predictable Solutions, With a standard. The cases decided since KSR have proved Reasonable Expectation of Success this fear to have been unfounded. Courts appear to be applying the KSR requirement for ªa ®nite To reject a claim based on this rationale, Of®ce number of identi®ed predictable solutionsº in a personnel must resolve the Graham factual manner that places particular emphasis on inquiries. Then, Of®ce personnel must articulate the predictability and the reasonable expectations of following: those of ordinary skill in the art.

(1) a ®nding that at the time of the invention, The Federal Circuit pointed out the challenging there had been a recognized problem or need in the nature of the task faced by the courts ± and likewise art, which may include a design need or market by Of®ce personnel ± when considering the viability pressure to solve a problem; of an obvious to try argument: ªThe evaluation of (2) a ®nding that there had been a ®nite number the choices made by a skilled scientist, when such of identi®ed, predictable potential solutions to the choices lead to the desired result, is a challenge to recognized need or problem; judicial understanding of how technical advance is (3) a ®nding that one of ordinary skill in the art achieved in the particular ®eld of science or could have pursued the known potential solutions technology.º Abbott Labs. v. Sandoz, Inc., 544 F.3d with a reasonable expectation of success; and 1341, 1352, 89 USPQ2d 1161, 1171 (Fed. Cir. 2008). The Federal Circuit cautioned that an (4) whatever additional ®ndings based on the obviousness inquiry based on an obvious to try Graham factual inquiries may be necessary, in view rationale must always be undertaken in the context of the facts of the case under consideration, to of the subject matter in question, ªincluding the explain a conclusion of obviousness. characteristics of the science or technology, its state The rationale to support a conclusion that the claim of advance, the nature of the known choices, the would have been obvious is that ªa person of speci®city or generality of the prior art, and the ordinary skill has good reason to pursue the known predictability of results in the area of interest.º Id. options within his or her technical grasp. If this leads Example 1: to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and The claimed invention in P®zer, Inc. v. Apotex, Inc., 480 F.3d common sense. In that instance the fact that a 1348, 82 USPQ2d 1321 (Fed. Cir. 2007), was directed to the amlodipine besylate drug product, which was sold in tablet form combination was obvious to try might show that it in the United States under the trademark Norvasc®. Amlodipine was obvious under § 103.º KSR, 550 U.S. at 421, and the use of besylate anions were both known at the time of 82 USPQ2d at 1397. If any of these ®ndings cannot the invention. Amlodipine was known to have the same be made, then this rationale cannot be used to therapeutic properties as were being claimed for the amlodipine support a conclusion that the claim would have been besylate, but P®zer discovered that the besylate form had better obvious to one of ordinary skill in the art. manufacturing properties (e.g., reduced ªstickinessº).

P®zer argued that the results of forming amlodipine besylate The question of whether a claimed invention can be would have been unpredictable and therefore nonobvious. The shown to be obvious based on an ªobvious to tryº court rejected the notion that unpredictability could be equated line of reasoning has been explored extensively by with nonobviousness here, because there were only a ®nite the Federal Circuit in several cases since the KSR number (53) of pharmaceutically acceptable salts to be tested for improved properties. decision. The case law in this area is developing quickly in the chemical arts, although the rationale The court found that one of ordinary skill in the art having has been applied in other art areas as well. problems with the machinability of amlodipine would have looked to forming a salt of the compound and would have been Some commentators on the KSR decision have able to narrow the group of potential salt-formers to a group of expressed a concern that because inventive activities 53 anions known to form pharmaceutically acceptable salts, which would be an acceptable number to form ªa reasonable are always carried out in the context of what has expectation of success.º come before and not in a vacuum, few inventions

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Example 2: expectation that a nucleic acid molecule within the claimed The claimed invention in Alza Corp. v. Mylan Labs., Inc., 464 scope could have been successfully obtained. F.3d 1286, 80 USPQ2d 1001 (Fed. Cir. 2006) was drawn to sustained-release formulations of the drug oxybutynin in which Relying on In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. the drug is released at a speci®ed rate over a 24-hour period. Cir. 1995), appellant argued that it was improper for the Of®ce Oxybutynin was known to be highly water-soluble, and the to use the polypeptide of the Valiante patent together with the speci®cation had pointed out that development of methods described in Sambrook to reject a claim drawn to a sustained-release formulations of such drugs presented particular speci®c nucleic acid molecule without providing a reference problems. showing or suggesting a structurally similar nucleic acid molecule. Citing KSR, the Board stated that ªwhen there is A prior art patent to Morella had taught sustained-release motivation to solve a problem and there are a ®nite number of compositions of highly water-soluble drugs, as exempli®ed by identi®ed, predictable solutions, a person of ordinary skill has a sustained-release formulation of morphine. Morella had also good reason to pursue the known options within his or her identi®ed oxybutynin as belonging to the class of highly technical grasp. If this leads to anticipated success, it is likely water-soluble drugs. The Baichwal prior art patent had taught the product not of innovation but of ordinary skill and common a sustained-release formulation of oxybutynin that had a different sense.º The Board noted that the problem facing those in the release rate than the claimed invention. Finally, the Wong prior art was to isolate a speci®c nucleic acid, and there were a limited art patent had taught a generally applicable method for delivery number of methods available to do so. The Board concluded of drugs over a 24-hour period. Although Wong mentioned that the skilled artisan would have had reason to try these applicability of the disclosed method to several categories of methods with the reasonable expectation that at least one would drugs to which oxybutynin belonged, Wong did not speci®cally be successful. Thus, isolating the speci®c nucleic acid molecule mention its applicability to oxybutynin. claimed was ªthe product not of innovation but of ordinary skill and common sense.º

The court found that because the absorption properties of oxybutynin would have been reasonably predictable at the time The Board's reasoning was substantially adopted by the Federal of the invention, there would have been a reasonable expectation Circuit. However, it is important to note that in the Kubin of successful development of a sustained-release formulation decision, the Federal Circuit held that ªthe Supreme Court in of oxybutynin as claimed. The prior art, as evidenced by the KSR unambiguously discreditedº the Federal Circuit's decision speci®cation, had recognized the obstacles to be overcome in in Deuel, insofar as it ªimplies the obviousness inquiry cannot development of sustained-release formulations of highly consider that the combination of the claim's constituent elements water-soluble drugs, and had suggested a ®nite number of ways was `obvious to try.'º Kubin, 561 F.3d at 1358, 90 USPQ2d at to overcome these obstacles. The claims were obvious because 1422. Instead, Kubin stated that KSR ªresurrectsº the Federal it would have been obvious to try the known methods for Circuit's own wisdom in O'Farrell, in which ªto differentiate formulating sustained-release compositions, with a reasonable between proper and improper applications of `obvious to try,'º expectation of success. The court was not swayed by arguments the Federal Circuit ªoutlined two classes of situations where of a lack of absolute predictability. `obvious to try' is erroneously equated with obviousness under § 103.º Kubin, 561 F.3d at 1359, 90 USPQ2d at 1423. These Example 3: two classes of situations are: (1) when what would have been ªobvious to tryº would have been to vary all parameters or try The Federal Circuit's decision in In re Kubin, 561 F.3d 1351, each of numerous possible choices until one possibly arrived at 90 USPQ2d 1417 (Fed. Cir. 2009), af®rmed the Of®ce's a successful result, where the prior art gave either no indication determination in Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. of which parameters were critical or no direction as to which of App. & Int. 2007) that the claims in question, directed to an many possible choices is likely to be successful; and (2) when isolated nucleic acid molecule, would have been obvious over what was ªobvious to tryº was to explore a new technology or the prior art applied. The claim stated that the nucleic acid general approach that seemed to be a promising ®eld of encoded a particular polypeptide. The encoded polypeptide was experimentation, where the prior art gave only general guidance identi®ed in the claim by its partially speci®ed sequence, and as to the particular form of the claimed invention or how to by its ability to bind to a speci®ed protein. achieve it. Id. (citing In re O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir.)). A prior art patent to Valiante taught the polypeptide encoded Example 4: by the claimed nucleic acid, but did not disclose either the sequence of the polypeptide, or the claimed isolated nucleic acid Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d molecule. However, Valiante did disclose that by employing 1350, 83 USPQ2d 1169 (Fed. Cir. 2007), is an example of a conventional methods such as those disclosed by a prior art chemical case in which the Federal Circuit found that the laboratory manual by Sambrook, the sequence of the polypeptide claimed invention was not obvious. The claimed compound was could be determined, and the nucleic acid molecule could be pioglitazone, a member of a class of drugs known as isolated. In view of Valiante's disclosure of the polypeptide, thiazolidinediones (TZDs) marketed by Takeda as a treatment and of routine prior art methods for sequencing the polypeptide for Type 2 diabetes. The Takeda case brings together the and isolating the nucleic acid molecule, the Board found that a concept of a ªlead compoundº and the obvious-to-try argument. person of ordinary skill in the art would have had a reasonable

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Alphapharm had ®led an Abbreviated New Drug Application rendered it unsuitable as a starting point for further research, with the Food and Drug Administration, which was a technical and taught the skilled artisan away from its use. Furthermore, act of infringement of Takeda's patent. When Takeda brought even if there had been reason to select compound b, there had suit, Alphapharm's defense was that Takeda's patent was invalid been no reasonable expectation of success associated with the due to obviousness. Alphapharm argued that a two-step particular modi®cations necessary to transform compound b modi®cation ± involving homologation and ring-walking ± of into the claimed compound pioglitazone. Thus, an obviousness a known compound identi®ed as ªcompound bº would have rejection based on an obvious to try rationale was not appropriate produced pioglitazone, and that it was therefore obvious. in this situation.

Example 5: The district court found that there would have been no reason to select compound b as a lead compound. There were a large The case of Ortho-McNeil Pharm., Inc. v. Mylan Labs, Inc., number of similar prior art TZD compounds; ®fty-four were 520 F.3d 1358, 86 USPQ2d 1196 (Fed. Cir. 2008), provides speci®cally identi®ed in Takeda's prior patent, and the district another example in which a chemical compound was determined court observed that ªhundreds of millionsº were more generally not to be obvious. The claimed subject matter was topiramate, disclosed. Although the parties agreed that compound b which is used as an anti-convulsant. represented the closest prior art, one reference taught certain disadvantageous properties associated with compound b, which according to the district court would have taught the skilled In the course of working toward a new anti-diabetic drug, artisan not to select that compound as a lead compound. The Ortho-McNeil's scientist had unexpectedly discovered that a district court found no prima facie case of obviousness, and reaction intermediate had anti-convulsant properties. Mylan's stated that even if a prima facie case had been established, it defense of invalidity due to obviousness rested on an obvious would have been overcome in this case in view of the unexpected to try argument. However, Mylan did not explain why it would lack of toxicity of pioglitazone. have been obvious to begin with an anti-diabetic drug precursor, especially the speci®c one that led to topiramate, if one had been seeking an anti-convulsant drug. The district court ruled on The Federal Circuit af®rmed the decision of the district court, summary judgment that Ortho-McNeil's patent was not invalid citing the need for a reason to modify a prior art compound. The for obviousness. Federal Circuit quoted KSR, stating:

The Federal Circuit af®rmed. The Federal Circuit pointed out The KSR Court recognized that ª[w]hen there is a design that there was no apparent reason a person of ordinary skill need or market pressure to solve a problem and there are would have chosen the particular starting compound or the a ®nite number of identi®ed, predictable solutions, a particular synthetic pathway that led to topiramate as an person of ordinary skill has good reason to pursue the intermediate. Furthermore, there would have been no reason to known options within his or her technical grasp.º KSR, test that intermediate for anticonvulsant properties if treating 550 U.S. at 421, 82 USPQ2d at 1397. In such diabetes had been the goal. The Federal Circuit recognized an circumstances, ªthe fact that a combination was obvious element of serendipity in this case, which runs counter to the to try might show that it was obvious under § 103.º Id. requirement for predictability. Summarizing their conclusion That is not the case here. Rather than identify predictable with regard to Mylan's obvious to try argument, the Federal solutions for antidiabetic treatment, the prior art disclosed Circuit stated: a broad selection of compounds any one of which could have been selected as a lead compound for further investigation. Signi®cantly, the closest prior art compound [T]his invention, contrary to Mylan's characterization, (compound b, the 6-methyl) exhibited negative properties does not present a ®nite (and small in the context of the that would have directed one of ordinary skill in the art art) number of options easily traversed to show away from that compound. Thus, this case fails to present obviousness. . . . KSR posits a situation with a ®nite, and the type of situation contemplated by the Court when it in the context of the art, small or easily traversed, number stated that an invention may be deemed obvious if it was of options that would convince an ordinarily skilled artisan ªobvious to try.º The evidence showed that it was not of obviousness. . . . [T]his clearly is not the easily obvious to try. traversed, small and ®nite number of alternatives that KSR suggested might support an inference of obviousness. Id. at 1364, 86 USPQ2d at 1201. Takeda, 492 F.3d at 1359, 83 USPQ2d at 1176.

Thus, Ortho-McNeil helps to clarify the Supreme Court's Accordingly, Of®ce personnel should recognize that the obvious requirement in KSR for ªa ®nite numberº of predictable to try rationale does not apply when the appropriate factual solutions when an obvious to try rationale is applied: under the ®ndings cannot be made. In Takeda, there was a recognized Federal Circuit's case law ª®niteº means ªsmall or easily need for treatment of diabetes. However, there was no ®nite traversedº in the context of the art in question. As taught in number of identi®ed, predictable solutions to the recognized Abbott, discussed above, it is essential that the inquiry be placed need, and no reasonable expectation of success. There were in the context of the subject matter at issue, and each case must numerous known TZD compounds, and although one clearly be decided on its own facts. represented the closest prior art, its known disadvantages

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Example 6: Example 7:

In Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d The case of Sano®-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1341, 91 USPQ2d 1569 (Fed. Cir. 2009), the claimed invention 89 USPQ2d 1370 (Fed. Cir. 2008), also sheds light on the was an oral contraceptive containing micronized drospirenone obvious to try line of reasoning. The claimed compound was marketed as Yasmin®. The prior art compound drospirenone clopidogrel, which is the dextrorotatory isomer of methyl alpha- was known to be a poorly water-soluble, acid-sensitive 5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate. compound with contraceptive effects. It was also known in the Clopidogrel is an anti-thrombotic compound used to treat or art that micronization improves the solubility of poorly water prevent heart attack or stroke. The racemate, or mixture of soluble drugs. dextrorotatory and levorotatory (D- and L-) isomers of the compound, was known in the prior art. The two forms had not previously been separated, and although the mixture was known Based on the known acid sensitivity, Bayer had studied how to have anti-thrombotic properties, the extent to which each of effectively an enteric-coated drospirenone tablet delivered a the individual isomers contributed to the observed properties of formulation as compared to an intravenous injection of the same the racemate was not known and was not predictable. formulation to measure the ªabsolute bioavailabilityº of the drug. Bayer added an unprotected (normal) drospirenone tablet and compared its bioavailability to that of the enteric-coated The district court assumed that in the absence of any additional formulation and the intravenous delivery. Bayer expected to information, the D-isomer would have been prima facie obvious ®nd that the enteric-coated tablet would produce a lower over the known racemate. However, in view of the evidence of bioavailability than an intravenous injection, while the normal unpredicted therapeutic advantages of the D-isomer presented pill would produce an even lower bioavailability than the in the case, the district court found that any prima facie case enteric-coated tablet. However, they found that despite of obviousness had been overcome. At trial, the experts for both observations that drospirenone would quickly isomerize in a parties testi®ed that persons of ordinary skill in the art could highly acidic environment (supporting the belief that an enteric not have predicted the degree to which the isomers would have coating would be necessary to preserve bioavailability), the exhibited different levels of therapeutic activity and toxicity. normal pill and the enteric-coated pill resulted in the same Both parties' experts also agreed that the isomer with greater bioavailability. Following this study, Bayer developed therapeutic activity would most likely have had greater toxicity. micronized drospirenone in a normal pill, the basis for the Sano® witnesses testi®ed that Sano®'s own researchers had disputed patent. believed that the separation of the isomers was unlikely to have been productive, and experts for both parties agreed that it was dif®cult to separate isomers at the time of the invention. The district court found that a person having ordinary skill in Nevertheless, when Sano® ultimately undertook the task of the art would have considered the prior art result that a separating the isomers, it found that they had the ªrare structurally related compound, spirorenone, though characteristic of `absolute stereoselectivity,'º whereby the acid-sensitive, would nevertheless absorb in vivo, would have D-isomer provided all of the favorable therapeutic activity but suggested the same result for drospirenone. It also found that no signi®cant toxicity, while the L-isomer produced no while another reference taught that drospirenone isomerizes in therapeutic activity but virtually all of the toxicity. Based on vitro when exposed to acid simulating the human stomach, a this record, the district court concluded that Apotex had not met person of ordinary skill would have been aware of the study's its burden of proving by clear and convincing evidence that shortcomings, and would have veri®ed the ®ndings as suggested Sano®'s patent was invalid for obviousness. The Federal Circuit by a treatise on the science of dosage form design, which would af®rmed the district court's conclusion. have then showed that no enteric coating was necessary. Of®ce personnel should recognize that even when only a small The Federal Circuit held that the patent was invalid because the number of possible choices exist, the obvious to try line of claimed formulation was obvious. The Federal Circuit reasoned reasoning is not appropriate when, upon consideration of all of that the prior art would have funneled the formulator toward the evidence, the outcome would not have been reasonably two options. Thus, the formulator would not have been required predictable and the inventor would not have had a reasonable to try all possibilities in a ®eld unreduced by the prior art. The expectation of success. In Bayer, there were art-based reasons prior art was not vague in pointing toward a general approach to expect that both the normal pill and the enteric-coated pill or area of exploration, but rather guided the formulator precisely would be therapeutically suitable, even though not all prior art to the use of either a normal pill or an enteric-coated pill. studies were in complete agreement. Thus, the result obtained was not unexpected. In Sano®, on the other hand, there was It is important for Of®ce personnel to recognize that the mere strong evidence that persons of ordinary skill in the art, prior to existence of a large number of options does not in and of itself the separation of the isomers, would have had no reason to lead to a conclusion of nonobviousness. Where the prior art expect that the D-isomer would have such strong therapeutic teachings lead one of ordinary skill in the art to a narrower set advantages as compared with the L-isomer. In other words, the of options, then that reduced set is the appropriate one to result in Sano® was unexpected. consider when determining obviousness using an obvious to try rationale. Example 8: In Rolls-Royce, PLC v. United Tech. Corp., 603 F.3d 1325, 95 USPQ2d 1097 (Fed. Cir. 2010), the Federal Circuit addressed

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the obvious to try rationale in the context of a fan blade for jet been obvious. Failure to meet a desired quota of e-mail recipients engines. The case had arisen out of an interference proceeding. was a recognized problem in the ®eld of e-mail marketing. The Finding that the district court had correctly determined that there prior art had also recognized three potential solutions: increasing was no interference-in-fact because Rolls-Royce's claims would the size of the initial recipient list; resending e-mails to recipients not have been obvious in light of United's application, the who did not receive them on the ®rst attempt; and selecting a Federal Circuit af®rmed. new recipient list and sending e-mails to them. The last option corresponded to the fourth step of the invention as claimed. The Federal Circuit described the fan blade of the count as follows: The Federal Circuit noted that based on ªsimple logic,º selecting a new list of recipients was more likely to result in the desired outcome than resending to those who had not received the e-mail Each fan blade has three regions ± an inner, an on the ®rst attempt. There had been no evidence of any intermediate, and an outer region. The area closest to the unexpected result associated with selecting a new recipient list, axis of rotation at the hub is the inner region. The area and no evidence that the method would not have had a farthest from the center of the engine and closest to the reasonable likelihood of success. Thus, the Federal Circuit casing surrounding the engine is the outer region. The concluded that, as required by KSR, there were a ª®nite number intermediate region falls in between. The count de®nes a of identi®ed, predictable solutions,º and that the obvious to try fan blade with a swept-forward inner region, a inquiry properly led to the legal conclusion of obviousness. swept-rearward intermediate region, and forward-leaning outer region. The Federal Circuit in Perfect Web also discussed the role of common sense in the determination of obviousness. The district Id. at 1328, 95 USPQ2d at 1099. court had cited KSR for the proposition that ª[a] person of ordinary skill is also a person of ordinary creativity, not an United had argued that it would have been obvious for a person automaton,º and found that ªthe ®nal step [of the claimed of ordinary skill in the art to try a fan blade design in which the invention] is merely the logical result of common sense sweep angle in the outer region was reversed as compared with application of the maxim `try, try again.'º In af®rming the prior art fan blades from rearward to forward sweep, in order district court, the Federal Circuit undertook an extended to reduce endwall shock. The Federal Circuit disagreed with discussion of common sense as it has been applied to the United's assessment that the claimed fan blade would have been obviousness inquiry, both before and since the KSR decision. obvious based on an obvious to try rationale. The Federal Circuit pointed out that in a proper obvious to try approach to The Federal Circuit pointed out that application of common obviousness, the possible options for solving a problem must sense is not really an innovation in the law of obviousness when have been ªknown and ®nite.º Id. at 1339, 95 USPQ2d at 1107 it stated, ªCommon sense has long been recognized to inform (citing Abbott, 544 F.3d at 1351, 89 USPQ2d at 1171). In this the analysis of obviousness if explained with suf®cient case, nothing in the prior art would have suggested that changing reasoning.º Perfect Web, 587 F.3d at 1328, 92 USPQ2d at 1853 the sweep angle as Rolls-Royce had done would have addressed (emphasis added). The Federal Circuit then provided a review the issue of endwall shock. Thus, the Federal Circuit concluded of a number of precedential cases that inform the understanding that changing the sweep angle ªwould not have presented itself of common sense, including In re Bozek, 416 F.2d 1385, 1390, as an option at all, let alone an option that would have been 163 USPQ 545, 549 (CCPA 1969) (explaining that a patent obvious to try.º Id. The decision in Rolls-Royce is a reminder examiner may rely on ªcommon knowledge and common sense to Of®ce personnel that the obvious to try rationale can properly of the person of ordinary skill in the art without any speci®c be used to support a conclusion of obviousness only when the hint or suggestion in a particular referenceº) and In re Zurko, claimed solution would have been selected from a ®nite number 258 F.3d 1379, 1383, 1385, 59 USPQ2d 1693 at 1695, 1697 of potential solutions known to persons of ordinary skill in the (Fed. Cir. 2001) (clarifying that a factual foundation is needed art. in order for an examiner to invoke ªgood common senseº in a case in which ªbasic knowledge and common sense was not Example 9: based on any evidence in the recordº). The Federal Circuit implicitly acknowledged in Perfect Web that the kind of strict The case of Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d evidence-based teaching, suggestion, or motivation required in 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), In re Lee, 277 F.3d 1338, 1344, 61 USPQ2d 1430, 1434 (Fed. provides an example in which the Federal Circuit held that a Cir. 2002), is not an absolute requirement for an obviousness claimed method for managing bulk e-mail distribution was rejection in light of the teachings of KSR. The Federal Circuit obvious on the basis of an obvious to try argument. In Perfect explained that ª[a]t the time [of the Lee decision], we required Web, the method required selecting the intended recipients, the PTO to identify record evidence of a teaching, suggestion, transmitting the e-mails, determining how many of the e-mails or motivation to combine references.º However, Perfect Web had been successfully received, and repeating the ®rst three went on to state that even under Lee, common sense could steps if a pre-determined minimum number of intended properly be applied when analyzing evidence relevant to recipients had not received the e-mail. obviousness. Citing DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 80 USPQ2d 1641 (Fed. Cir. 2006), and In The Federal Circuit af®rmed the district court's determination re Kahn, 441 F.3d 977, 78 USPQ2d 1329 (Fed. Cir. 2006), two on summary judgment that the claimed invention would have cases decided shortly before the Supreme Court's decision in

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Example 1: KSR, the Federal Circuit noted that although ªa reasoned explanation that avoids conclusory generalizationsº is required The fact pattern in Dann v. Johnston, 425 U.S. 219, 189 USPQ to use common sense, identi®cation of a ªspeci®c hint or 257 (1976) is set forth above in Example 1 in subsection D. suggestion in a particular referenceº is not.

The Court found that the problem addressed by applicant ± the F. Known Work in One Field of Endeavor May Prompt need to give more detailed breakdown by a category of Variations of It for Use in Either the Same Field or a transactions ± was closely analogous to the task of keeping track Different One Based on Design Incentives or Other of the transaction ®les of individual business units. Id. at 229, Market Forces if the Variations Are Predictable to One 189 USPQ at 261. Thus, an artisan in the data processing area of Ordinary Skill in the Art would have recognized the similar class of problem and the known solutions of the prior art and it would have been well within the ordinary skill level to implement the system in the To reject a claim based on this rationale, Of®ce different environment. The Court held that ª[t]he gap between personnel must resolve the Graham factual the prior art and respondent's system is simply not so great as inquiries. Then, Of®ce personnel must articulate the to render the system nonobvious to one reasonably skilled in following: the art.º Id. at 230, 189 USPQ at 261. Example 2: (1) a ®nding that the scope and content of the prior art, whether in the same ®eld of endeavor as The claimed invention in Leapfrog Enterprises, Inc. v. that of the applicant's invention or a different ®eld Fisher-Price, Inc., 485 F.3d 1157, 82 USPQ2d 1687 (Fed. Cir. 2007) was directed to a learning device to help young children of endeavor, included a similar or analogous device read phonetically. The claim read as follows: (method, or product); (2) a ®nding that there were design incentives An interactive learning device, comprising: or market forces which would have prompted adaptation of the known device (method, or product); a housing including a plurality of switches;

(3) a ®nding that the differences between the a sound production device in communication with the switches claimed invention and the prior art were and including a processor and a memory; encompassed in known variations or in a principle known in the prior art; at least one depiction of a sequence of letters, each letter being associable with a switch; and (4) a ®nding that one of ordinary skill in the art, in view of the identi®ed design incentives or other a reader con®gured to communicate the identity of the depiction market forces, could have implemented the claimed to the processor, variation of the prior art, and the claimed variation would have been predictable to one of ordinary skill wherein selection of a depicted letter activates an associated in the art; and switch to communicate with the processor, causing the sound production device to generate a signal corresponding to a sound (5) whatever additional ®ndings based on the associated with the selected letter, the sound being determined Graham factual inquiries may be necessary, in view by a position of the letter in the sequence of letter. of the facts of the case under consideration, to explain a conclusion of obviousness. The court concluded that the claimed invention would have been obvious in view of the combination of two pieces of prior art, The rationale to support a conclusion that the (1) Bevan (which showed an electro-mechanical toy for phonetic claimed invention would have been obvious is that learning), (2) the Super Speak & Read device (SSR) (an design incentives or other market forces could have electronic reading toy), and the knowledge of one of ordinary skill in the art. prompted one of ordinary skill in the art to vary the prior art in a predictable manner to result in the The court made clear that there was no technological advance claimed invention. If any of these ®ndings cannot beyond the skill shown in the SSR device. The court stated that be made, then this rationale cannot be used to ªone of ordinary skill in the art of children's learning toys would support a conclusion that the claim would have been have found it obvious to combine the Bevan device with the obvious to one of ordinary skill in the art. SSR to update it using modern electronic components in order to gain the commonly understood bene®ts of such adaptation, such as decreased size, increased reliability, simpli®ed operation, and reduced cost. While the SSR only permits generation of a

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sound corresponding to the ®rst letter of a word, it does so using detect the pedal's position was a pivot point. The Court electronic means. The combination is thus the adaptation of an concluded that it would have been obvious to upgrade Asano's old idea or invention (Bevan) using newer technology that is ®xed pivot point adjustable pedal by replacing the mechanical commonly available and understood in the art (the SSR).º assembly for throttle control with an electronic throttle control and to mount the electronic sensor on the pedal support structure. The court found that the claimed invention was but a variation Example 4: on already known children's toys. This variation presented no nonobvious advance over other toys. The court made clear that The claimed invention in Ex parte Catan, 83 USPQ2d 1568 there was no technological advance beyond the skill shown in (Bd. Pat. App. & Int. 2007), was a consumer electronics device the SSR device. The court found that ª[a]ccomodating a prior using bioauthentication to authorize sub-users of an authorized art mechanical device that accomplishes that goal to modern credit account to place orders over a communication network electronics would have been reasonably obvious to one of up to a pre-set maximum sub-credit limit. ordinary skill in designing children's learning devices. Applying modern electronics to older mechanical devices has been commonplace in recent years.º The prior art (Nakano) disclosed a consumer electronics device like the claimed invention, except that security was provided Example 3: by a password authentication device rather than a bioauthentication device. The prior art (Harada) disclosed that The claimed invention in KSR Int©l Co. v. Tele¯ex Inc., 550 the use of a bioauthentication device (®ngerprint sensor) on a U.S. 398, 82 USPQ2d 1385 (2007), was an adjustable pedal consumer electronics device (remote control) to provide assembly with a ®xed pivot point and an electronic bioauthentication information (®ngerprint) was known in the pedal-position sensor attached to the assembly support. The prior art at the time of the invention. The prior art (Dethloff) ®xed pivot point meant that the pivot was not changed as the also disclosed that it was known in the art at the time of the pedal was adjusted. The placement of the sensor on the assembly invention to substitute bioauthentication for PIN authentication support kept the sensor ®xed while the pedal was adjusted. to enable a user to access credit via a consumer electronics device. Conventional gas pedals operated by a mechanical link which adjusted the throttle based on the travel of the pedal from a set The Board found that the prior art ªshows that one of ordinary position. The throttle controlled the combustion process and the skill in the consumer electronic device art at the time of the available power generated by the engine. Newer cars used invention would have been familiar with using bioauthentication computer controlled throttles in which a sensor detected the information interchangeably with or in lieu of PINs to motion of the pedal and sent signals to the engine to adjust the authenticate users.º The Board concluded that one of ordinary throttle accordingly. At the time of the invention, the skill in the art of consumer electronic devices would have found marketplace provided a strong incentive to convert mechanical it obvious to update the prior art password device with the pedals to electronic pedals, and the prior art taught a number of modern bioauthentication component and thereby gain, methods for doing so. The prior art (Asano) taught an adjustable predictably, the commonly understood bene®ts of such pedal with a ®xed pivot point with mechanical throttle control. adaptation, that is, a secure and reliable authentication procedure. The prior art (`936 patent to Byler) taught an electronic pedal sensor which was placed on a pivot point in the pedal assembly G. Some Teaching, Suggestion, or Motivation in the and that it was preferable to detect the pedal's position in the Prior Art That Would Have Led One of Ordinary Skill pedal mechanism rather than in the engine. The prior art (Smith) taught that to prevent the wires connecting the sensor to the To Modify the Prior Art Reference or To Combine Prior computer from cha®ng and wearing out, the sensor should be Art Reference Teachings To Arrive at the Claimed put on a ®xed part of the pedal assembly rather than in or on Invention the pedal's footpad. The prior art (Rixon) taught an adjustable pedal assembly (sensor in the footpad) with an electronic sensor To reject a claim based on this rationale, Of®ce for throttle control. There was no prior art electronic throttle control that was combined with a pedal assembly which kept personnel must resolve the Graham factual the pivot point ®xed when adjusting the pedal. inquiries. Then, Of®ce personnel must articulate the following: The Court stated that ª[t]he proper question to have asked was whether a pedal designer of ordinary skill, facing the wide range (1) a ®nding that there was some teaching, of needs created by developments in the ®eld of endeavor, would suggestion, or motivation, either in the references have seen a bene®t to upgrading Asano with a sensor.º Id. at themselves or in the knowledge generally available 424, 82 USPQ2d at 1399. The Court found that technological developments in the automotive design would have prompted to one of ordinary skill in the art, to modify the a designer to upgrade Asano with an electronic sensor. The next reference or to combine reference teachings; question was where to attach the sensor. Based on the prior art, a designer would have known to place the sensor on a (2) a ®nding that there was reasonable nonmoving part of the pedal structure and the most obvious expectation of success; and nonmoving point on the structure from which a sensor can easily

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(3) whatever additional ®ndings based on the suggestion, or motivation to do so. In re Kahn, 441 Graham factual inquiries may be necessary, in view F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. of the facts of the case under consideration, to 2006) (discussing rationale underlying the explain a conclusion of obviousness. motivation-suggestion-teaching test as a guard The rationale to support a conclusion that the claim against using hindsight in an obviousness analysis). would have been obvious is that "a person of ordinary skill in the art would have been motivated I. PRIOR ART SUGGESTION OF THE CLAIMED INVENTION NOT NECESSARILY NEGATED BY to combine the prior art to achieve the claimed DESIRABLE ALTERNATIVES invention and whether there would have been a reasonable expectation of success in doing so." The disclosure of desirable alternatives does not DyStar Textilfarben GmbH & Co. Deutschland KG necessarily negate a suggestion for modifying the v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 prior art to arrive at the claimed invention. In In re USPQ2d 1641, 1645 (Fed. Cir. 2006). If any of these Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. ®ndings cannot be made, then this rationale cannot 2004), the claims of a utility patent application were be used to support a conclusion that the claim would directed to a shoe sole with increased traction having have been obvious to one of ordinary skill in the art. hexagonal projections in a ªfacing orientation.º 391 F.3d at 1196-97, 73 USPQ2d at 1142. The Board The courts have made clear that the teaching, combined a design patent having hexagonal suggestion, or motivation test is ¯exible and an projections in a facing orientation with a utility explicit suggestion to combine the prior art is not patent having other limitations of the independent necessary. The motivation to combine may be claim. 391 F.3d at 1199, 73 USPQ2d at 1144. implicit and may be found in the knowledge of one Applicant argued that the combination was improper of ordinary skill in the art, or, in some cases, from because (1) the prior art did not suggest having the the nature of the problem to be solved. Id. at 1366, hexagonal projections in a facing (as opposed to a 80 USPQ2d at 1649. ª[A]n implicit motivation to ªpointingº) orientation was the ªmost desirableº combine exists not only when a suggestion may be con®guration for the projections, and (2) the prior gleaned from the prior art as a whole, but when the art ªtaught awayº by showing desirability of the `improvement' is technology-independent and the ªpointing orientation.º 391 F.3d at 1200-01, 73 combination of references results in a product or USPQ2d at 1145-46. The court stated that ªthe prior process that is more desirable, for example because art's mere disclosure of more than one alternative it is stronger, cheaper, cleaner, faster, lighter, does not constitute a teaching away from any of these smaller, more durable, or more ef®cient. Because alternatives because such disclosure does not the desire to enhance commercial opportunities by criticize, discredit, or otherwise discourage the improving a product or process is universal-and even solution claimed¼.º Id. In af®rming the Board's common-sensical-we have held that there exists in obviousness rejection, the court held that the prior these situations a motivation to combine prior art art as a whole suggested the desirability of the references even absent any hint of suggestion in the combination of shoe sole limitations claimed, thus references themselves. In such situations, the proper providing a motivation to combine, which need not question is whether the ordinary artisan possesses be supported by a ®nding that the prior art suggested knowledge and skills rendering him capable of that the combination claimed by the applicant was combining the prior art references.º Id. at 1368, 80 the preferred, or most desirable combination over USPQ2d at 1651. the other alternatives. Id.

2143.01 Suggestion or Motivation To Modify In Ruiz v. A.B. Chance Co., 357 F.3d 1270, the References [R-11.2013] 69 USPQ2d 1686 (Fed. Cir. 2004), the patent claimed underpinning a slumping building Obviousness can be established by combining or foundation using a screw anchor attached to the modifying the teachings of the prior art to produce foundation by a metal bracket. One prior art the claimed invention where there is some teaching, reference taught a screw anchor with a concrete

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bracket, and a second prior art reference disclosed SUFFICIENT TO ESTABLISH PRIMA FACIE a pier anchor with a metal bracket. The court found OBVIOUSNESS motivation to combine the references to arrive at the claimed invention in the ªnature of the problem to The mere fact that references can be combined or be solvedº because each reference was directed ªto modi®ed does not render the resultant combination precisely the same problem of underpinning obvious unless the results would have been slumping foundations.º Id. at 1276, 69 USPQ2d at predictable to one of ordinary skill in the art. KSR 1690. The court also rejected the notion that ªan Int©l Co. v. Tele¯ex Inc., 550 U.S. 538, 417, 82 express written motivation to combine must appear USPQ2d 1385, 1396 (2007) (ªIf a person of ordinary in prior art references¼.º Id. at 1276, 69 USPQ2d skill can implement a predictable variation, § 103 at 1690. likely bars its patentability. For the same reason, if a technique has been used to improve one device, II. WHERE THE TEACHINGS OF THE PRIOR and a person of ordinary skill in the art would ART CONFLICT, THE EXAMINER MUST WEIGH recognize that it would improve similar devices in THE SUGGESTIVE POWER OF EACH the same way, using the technique is obvious unless REFERENCE its actual application is beyond his or her skill.º).

The test for obviousness is what the combined IV. MERE STATEMENT THAT THE CLAIMED teachings of the references would have suggested to INVENTION IS WITHIN THE CAPABILITIES OF one of ordinary skill in the art, and all teachings in ONE OF ORDINARY SKILL IN THE ART IS NOT the prior art must be considered to the extent that SUFFICIENT BY ITSELF TO ESTABLISH PRIMA they are in analogous arts. Where the teachings of FACIE OBVIOUSNESS two or more prior art references con¯ict, the examiner must weigh the power of each reference A statement that modi®cations of the prior art to to suggest solutions to one of ordinary skill in the meet the claimed invention would have been ª`well art, considering the degree to which one reference within the ordinary skill of the art at the time the might accurately discredit another. In re Young, 927 claimed invention was made'º because the references F.2d 588, 18 USPQ2d 1089 (Fed. Cir. 1991) (Prior relied upon teach that all aspects of the claimed art patent to Carlisle disclosed controlling and invention were individually known in the art is not minimizing bubble oscillation for chemical suf®cient to establish a prima facie case of explosives used in marine seismic exploration by obviousness without some objective reason to spacing seismic sources close enough to allow the combine the teachings of the references. Ex parte bubbles to intersect before reaching their maximum Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. radius so the secondary pressure pulse was reduced. 1993). ```[R]ejections on obviousness cannot be An article published several years later by Knudsen sustained by mere conclusory statements; instead, opined that the Carlisle technique does not yield there must be some articulated reasoning with some appreciable improvement in bubble oscillation rational underpinning to support the legal conclusion suppression. However, the article did not test the of obviousness.'º KSR, 550 U.S. at 418, 82 USPQ2d Carlisle technique under comparable conditions at 1396 (quoting In re Kahn, 441 F.3d 977, 988, 78 because Knudsen did not use Carlisle's spacing or USPQ2d 1329, 1336 (Fed. Cir. 2006)). seismic source. Furthermore, where the Knudsen model most closely approximated the patent V. THE PROPOSED MODIFICATION CANNOT technique there was a 30% reduction of the RENDER THE PRIOR ART UNSATISFACTORY secondary pressure pulse. On these facts, the court FOR ITS INTENDED PURPOSE found that the Knudsen article would not have deterred one of ordinary skill in the art from using If proposed modi®cation would render the prior art the Carlisle patent teachings.). invention being modi®ed unsatisfactory for its intended purpose, then there is no suggestion or III. FACT THAT REFERENCES CAN BE motivation to make the proposed modi®cation. In COMBINED OR MODIFIED MAY NOT BE re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984) (Claimed device was a blood ®lter assembly

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for use during medical procedures wherein both the 1959) (Claims were directed to an oil seal inlet and outlet for the blood were located at the comprising a bore engaging portion with outwardly bottom end of the ®lter assembly, and wherein a gas biased resilient spring ®ngers inserted in a resilient vent was present at the top of the ®lter assembly. sealing member. The primary reference relied upon The prior art reference taught a liquid strainer for in a rejection based on a combination of references removing dirt and water from gasoline and other disclosed an oil seal wherein the bore engaging light oils wherein the inlet and outlet were at the top portion was reinforced by a cylindrical sheet metal of the device, and wherein a pet-cock (stopcock) casing. Patentee taught the device required rigidity was located at the bottom of the device for for operation, whereas the claimed invention required periodically removing the collected dirt and water. resiliency. The court reversed the rejection holding The reference further taught that the separation is the ªsuggested combination of references would assisted by gravity. The Board concluded the claims require a substantial reconstruction and redesign of were prima facie obvious, reasoning that it would the elements shown in [the primary reference] as have been obvious to turn the reference device well as a change in the basic principle under which upside down. The court reversed, ®nding that if the the [primary reference] construction was designed prior art device was turned upside down it would be to operate.º). inoperable for its intended purpose because the gasoline to be ®ltered would be trapped at the top, 2143.02 Reasonable Expectation of Success the water and heavier oils sought to be separated Is Required [R-08.2012] would ¯ow out of the outlet instead of the puri®ed gasoline, and the screen would become clogged.). [Editor Note: This MPEP section is applicable to applications subject to the ®rst inventor to ®le ªAlthough statements limiting the function or (FITF) provisions of the AIA except that the relevant capability of a prior art device require fair date is the "effective ®ling date" of the claimed consideration, simplicity of the prior art is rarely a invention instead of the "time the invention was characteristic that weighs against obviousness of a made," which is only applicable to applications more complicated device with added function.º In subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 re Dance, 160 F.3d 1339, 1344, 48 USPQ2d 1635, (note) and MPEP § 2150 et seq.] 1638 (Fed. Cir. 1998) (Court held that claimed catheter for removing obstruction in blood vessels A rationale to support a conclusion that a claim would have been obvious in view of a ®rst reference would have been obvious is that all the claimed which taught all of the claimed elements except for elements were known in the prior art and one skilled a ªmeans for recovering ¯uid and debrisº in in the art could have combined the elements as combination with a second reference describing a claimed by known methods with no change in their catheter including that means. The court agreed that respective functions, and the combination would the ®rst reference, which stressed simplicity of have yielded nothing more than predictable results structure and taught emulsi®cation of the debris, did to one of ordinary skill in the art. KSR Int©l Co. v. not teach away from the addition of a channel for Tele¯ex Inc., 550 U.S. 538, 416, 82 USPQ2d 1385, the recovery of the debris.). 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); VI. THE PROPOSED MODIFICATION CANNOT Anderson's-Black Rock, Inc. v. Pavement Salvage CHANGE THE PRINCIPLE OF OPERATION OF Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); A REFERENCE Great Atlantic & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). If the proposed modi®cation or combination of the prior art would change the principle of operation of I. OBVIOUSNESS REQUIRES A REASONABLE the prior art invention being modi®ed, then the EXPECTATION OF SUCCESS teachings of the references are not suf®cient to render the claims prima facie obvious. In re Ratti, Where there is a reason to modify or combine the 270 F.2d 810, 813, 123 USPQ 349, 352 (CCPA prior art to achieve the claimed invention, the claims

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may be rejected as prima facie obvious provided over a reference which taught the claimed method there is also a reasonable expectation of success. In at atmospheric pressure in view of a reference which re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ taught the claimed process except for the presence 375 (Fed. Cir. 1986) (Claims directed to a method of a solvent. The court reversed, ®nding there was of treating depression with amitriptyline (or nontoxic no reasonable expectation that a process combining salts thereof) were rejected as prima facie obvious the prior art steps could be successfully scaled up in over prior art disclosures that amitriptyline is a view of unchallenged evidence showing that the compound known to possess psychotropic properties prior art processes individually could not be and that imipramine is a structurally similar commercially scaled up successfully.). See also psychotropic compound known to possess Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, antidepressive properties, in view of prior art 1207-08, 18 USPQ2d 1016, 1022-23 (Fed. Cir.), suggesting the aforementioned compounds would cert. denied, 502 U.S. 856 (1991) (In the context of be expected to have similar activity because the a biotechnology case, testimony supported the structural difference between the compounds conclusion that the references did not show that there involves a known bioisosteric replacement and was a reasonable expectation of success.); In re because a research paper comparing the O'Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 pharmacological properties of these two compounds (Fed. Cir. 1988) (The court held the claimed method suggested clinical testing of amitriptyline as an would have been obvious over the prior art relied antidepressant. The court sustained the rejection, upon because one reference contained a detailed ®nding that the teachings of the prior art provide a enabling methodology, a suggestion to modify the suf®cient basis for a reasonable expectation of prior art to produce the claimed invention, and success.); Ex parte Blanc, 13 USPQ2d 1383 (Bd. evidence suggesting the modi®cation would be Pat. App. & Inter. 1989) (Claims were directed to a successful.). process of sterilizing a polyole®nic composition with high-energy radiation in the presence of a phenolic III. PREDICTABILITY IS DETERMINED AT THE polyester antioxidant to inhibit discoloration or TIME THE INVENTION WAS MADE degradation of the polyole®n. Appellant argued that it is unpredictable whether a particular antioxidant Whether an art is predictable or whether the will solve the problem of discoloration or proposed modi®cation or combination of the prior degradation. However, the Board found that because art has a reasonable expectation of success is the prior art taught that appellant's preferred determined at the time the invention was made. Ex antioxidant is very ef®cient and provides better parte Erlich, 3 USPQ2d 1011, 1016 (Bd. Pat. App. results compared with other prior art antioxidants, & Inter. 1986) (Although an earlier case reversed a there would have been a reasonable expectation of rejection because of unpredictability in the ®eld of success.). monoclonal antibodies, the court found ªin this case at the time this invention was made, one of ordinary II. AT LEAST SOME DEGREE OF skill in the art would have been motivated to produce PREDICTABILITY IS REQUIRED; APPLICANTS monoclonal antibodies speci®c for human ®broplast MAY PRESENT EVIDENCE SHOWING THERE interferon using the method of [the prior art] with a WAS NO REASONABLE EXPECTATION OF reasonable expectation of success.º) (emphasis in SUCCESS original).

Obviousness does not require absolute predictability, 2143.03 All Claim Limitations Must Be however, at least some degree of predictability is Considered [R-08.2012] required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, ªAll words in a claim must be considered in judging 189 USPQ 143 (CCPA 1976) (Claims directed to a the patentability of that claim against the prior art.º method for the commercial scale production of In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, polyesters in the presence of a solvent at 496 (CCPA 1970). If an independent claim is superatmospheric pressure were rejected as obvious nonobvious under 35 U.S.C. 103, then any claim

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depending therefrom is nonobvious. In re Fine, 837 invention would have been obvious in view of the F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988). prior art.).

I. INDEFINITE LIMITATIONS MUST BE 2144 Supporting a Rejection Under 35 U.S.C. CONSIDERED 103 [R-07.2015]

A claim limitation which is considered inde®nite When considering obviousness, Of®ce personnel cannot be disregarded. If a claim is subject to more are cautioned against treating any line of reasoning than one interpretation, at least one of which would as a per se rule. This section discusses supporting a render the claim unpatentable over the prior art, the rejection under 35 U.S.C. 103 by reliance on examiner should reject the claim as inde®nite under scienti®c theory and legal precedent. In keeping with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second the ¯exible approach to obviousness under KSR, as paragraph (see MPEP § 706.03(d)) and should reject well as the requirement for explanation, Of®ce the claim over the prior art based on the personnel may invoke legal precedent as a source interpretation of the claim that renders the prior art of supporting rationale when warranted and applicable. Ex parte Ionescu, 222 USPQ 537 (Bd. appropriately supported. See MPEP § 2144.04. So, Pat. App. & Inter. 1984) (Claims on appeal were for example, automating a manual activity, making rejected on inde®niteness grounds only; the rejection portable, making separable, reversing or duplicating was reversed and the case remanded to the examiner parts, or purifying an old product may form the basis for consideration of pertinent prior art.). Compare of a rejection. However, such rationales should not In re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA be treated as per se rules, but rather must be 1970) (if no reasonably de®nite meaning can be explained and shown to apply to the facts at hand. ascribed to certain claim language, the claim is A similar caveat applies to any obviousness analysis. inde®nite, not obvious) and In re Steele, 305 F.2d Simply stating the principle (e.g., ªart recognized 859,134 USPQ 292 (CCPA 1962) (it is improper to equivalent,º ªstructural similarityº) without rely on speculative assumptions regarding the providing an explanation of its applicability to the meaning of a claim and then base a rejection under facts of the case at hand is generally not suf®cient 35 U.S.C. 103 on these assumptions). to establish a prima facie case of obviousness.

II. LIMITATIONS WHICH DO NOT FIND I. RATIONALE MAY BE IN A REFERENCE, OR SUPPORT IN THE ORIGINAL SPECIFICATION REASONED FROM COMMON KNOWLEDGE IN MUST BE CONSIDERED THE ART, SCIENTIFIC PRINCIPLES, ART-RECOGNIZED EQUIVALENTS, OR LEGAL When evaluating claims for obviousness under PRECEDENT 35 U.S.C. 103, all the limitations of the claims must be considered and given weight, including limitations The rationale to modify or combine the prior art does which do not ®nd support in the speci®cation as not have to be expressly stated in the prior art; the originally ®led (i.e., new matter). Ex parte Grasselli, rationale may be expressly or impliedly contained 231 USPQ 393 (Bd. App. 1983) aff'd mem. 738 in the prior art or it may be reasoned from knowledge F.2d 453 (Fed. Cir. 1984) (Claim to a catalyst generally available to one of ordinary skill in the art, expressly excluded the presence of sulfur, halogen, established scienti®c principles, or legal precedent uranium, and a combination of vanadium and established by prior case law. In re Fine, 837 F.2d phosphorous. Although the negative limitations 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, excluding these elements did not appear in the 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). speci®cation as ®led, it was error to disregard these See also In re Kotzab, 217 F.3d 1365, 1370, 55 limitations when determining whether the claimed USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502

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(Fed. Cir. 1988) (references do not have to explicitly by the court to support an obviousness rejection. suggest combining teachings); Ex parte Clapp, 227 ªThe value of the exceedingly large body of USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner precedent wherein our predecessor courts and this must present convincing line of reasoning supporting court have applied the law of obviousness to rejection); and Ex parte Levengood, 28 USPQ2d particular facts, is that there has been built a wide 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic spectrum of illustrations and accompanying and sound scienti®c reasoning). reasoning, that have been melded into a fairly consistent application of law to a great variety of II. THE EXPECTATION OF SOME ADVANTAGE facts.º In re Eli Lilly & Co., 902 F.2d 943, 14 IS THE STRONGEST RATIONALE FOR USPQ2d 1741 (Fed. Cir. 1990). COMBINING REFERENCES IV. RATIONALE DIFFERENT FROM The strongest rationale for combining references is APPLICANT'S IS PERMISSIBLE a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based The reason or motivation to modify the reference on established scienti®c principles or legal precedent, may often suggest what the inventor has done, but that some advantage or expected bene®cial result for a different purpose or to solve a different would have been produced by their combination. In problem. It is not necessary that the prior art suggest re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, the combination to achieve the same advantage or 5-6 (Fed. Cir. 1983). See also Dystar Textilfarben result discovered by applicant. See, e.g., In re Kahn, GmbH & Co. Deutschland KG v. C.H. Patrick, 464 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. Cir. 2006) (motivation question arises in the context 2006) (ªIndeed, we have repeatedly held that an of the general problem confronting the inventor implicit motivation to combine exists not only when rather than the speci®c problem solved by the a suggestion may be gleaned from the prior art as a invention); Cross Med. Prods., Inc. v. Medtronic whole, but when the `improvement' is Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 technology-independent and the combination of USPQ2d 1662, 1685 (Fed. Cir. 2005) (ªOne of references results in a product or process that is more ordinary skill in the art need not see the identical desirable, for example because it is stronger, cheaper, problem addressed in a prior art reference to be cleaner, faster, lighter, smaller, more durable, or motivated to apply its teachings.º); In re Lintner, more ef®cient. Because the desire to enhance 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) commercial opportunities by improving a product (discussed below); In re Dillon, 919 F.2d 688, 16 or process is universalÐand even USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 common-sensicalÐwe have held that there exists in U.S. 904 (1991) (discussed below). these situations a motivation to combine prior art references even absent any hint of suggestion in the In In re Lintner, the claimed invention was a laundry references themselves.º). composition consisting essentially of a dispersant, cationic fabric softener, sugar, sequestering III. LEGAL PRECEDENT CAN PROVIDE THE phosphate, and brightener in speci®ed proportions. RATIONALE SUPPORTING OBVIOUSNESS ONLY The claims were rejected over the combination of a IF THE FACTS IN THE CASE ARE SUFFICIENTLY primary reference which taught all the claim SIMILAR TO THOSE IN THE APPLICATION limitations except for the presence of sugar, and secondary references which taught the addition of The examiner must apply the law consistently to sugar as a ®ller or weighting agent in compositions each application after considering all the relevant containing cationic fabric softeners. Appellant facts. If the facts in a prior legal decision are argued that in the claimed invention, the sugar is suf®ciently similar to those in an application under responsible for the compatibility of the cationic examination, the examiner may use the rationale softener with the other detergent components. The used by the court. If the applicant has demonstrated court sustained the rejection, stating ªThe fact that the criticality of a speci®c limitation, it would not appellant uses sugar for a different purpose does not be appropriate to rely solely on the rationale used

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alter the conclusion that its use in a prior art was found to be met by a reference which expressly composition would be [ sic, would have been] prima taught the same process at 700°C because the facie obvious from the purpose disclosed in the reference recognized the possibility of using references.º 173 USPQ at 562. temperatures greater than 750°C. The reference disclosed that catalytic processes for converting In In re Dillon, applicant claimed a composition methane with sulfur vapors into carbon disul®de at comprising a hydrocarbon fuel and a suf®cient temperatures greater than 750°C (albeit without amount of a tetra-orthoester of a speci®ed formula charcoal) was known, and that 700°C was ªmuch to reduce the particulate emissions from the lower than had previously proved feasible.º); In re combustion of the fuel. The claims were rejected as Lamberti, 545 F.2d 747, 750, 192 USPQ 278, 280 obvious over a reference which taught hydrocarbon (CCPA 1976) (Reference disclosure of a compound fuel compositions containing tri-orthoesters for where the R-S-R¢ portion has ªat least one dewatering fuels, in combination with a reference methylene group attached to the sulfur atomº implies teaching the equivalence of tri-orthoesters and that the other R group attached to the sulfur atom tetra-orthoesters as water scavengers in hydraulic can be other than methylene and therefore suggests (nonhydrocarbon) ¯uids. The Board af®rmed the asymmetric dialkyl moieties.). rejection ®nding ªthere was a `reasonable expectation' that the tri- and tetra-orthoester fuel 2144.02 Reliance on Scienti®c Theory compositions would have similar properties based [R-08.2012] on `close structural and chemical similarity' between the tri- and tetra-orthoesters and the fact that both The rationale to support a rejection under 35 U.S.C. the prior art and Dillon use these compounds `as fuel 103 may rely on logic and sound scienti®c principle. additives'.º 919 F.2d at 692, 16 USPQ2d at 1900. In re Soli, 317 F.2d 941, 137 USPQ 797 (CCPA The court held ªit is not necessary in order to 1963). However, when an examiner relies on a establish a prima facie case of obviousness . . . that scienti®c theory, evidentiary support for the there be a suggestion or expectation from the prior existence and meaning of that theory must be art that the claimed [invention] will have the same provided. In re Grose, 592 F.2d 1161, 201 USPQ or a similar utility as one newly discovered by 57 (CCPA 1979) (Court held that different crystal applicant,º and concluded that here a prima facie forms of zeolites would not have been structurally case was established because ª[t]he art provided the obvious one from the other because there was no motivation to make the claimed compositions in the chemical theory supporting such a conclusion. The expectation that they would have similar properties.º known chemical relationship between structurally 919 F.2d at 693, 16 USPQ2d at 1901 (emphasis in similar compounds (homologs, analogs, isomers) original). did not support a ®nding of prima facie obviousness of claimed zeolite over the prior art because a zeolite See MPEP § 2145, subsection II for case law is not a compound but a mixture of compounds pertaining to the presence of additional advantages related to each other by a particular crystal or latent properties not recognized in the prior art. structure.).

2144.01 Implicit Disclosure [R-08.2012] 2144.03 Reliance on Common Knowledge in the Art or ªWell Knownº Prior Art ª[I]n considering the disclosure of a reference, it is [R-08.2012] proper to take into account not only speci®c teachings of the reference but also the inferences In certain circumstances where appropriate, an which one skilled in the art would reasonably be examiner may take of®cial notice of facts not in the expected to draw therefrom.º In re Preda, 401 F.2d record or rely on ªcommon knowledgeº in making 825, 826, 159 USPQ 342, 344 (CCPA 1968) (A a rejection, however such rejections should be process for catalytically producing carbon disul®de judiciously applied. by reacting sulfur vapor and methane in the presence of charcoal at a temperature of ªabout 750-830°Cº

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PROCEDURE FOR RELYING ON COMMON reasonable to take of®cial notice of the fact that it KNOWLEDGE OR TAKING OFFICIAL NOTICE is desirable to make something faster, cheaper, better, or stronger without the speci®c support of The standard of review applied to ®ndings of fact is documentary evidence. Furthermore, it might be the ªsubstantial evidenceº standard under the reasonable for the examiner in a ®rst Of®ce action Administrative Procedure Act (APA), 5 U.S.C. 500 to take of®cial notice of facts by asserting that et seq. See In re Gartside, 203 F.3d 1305, 1315, certain limitations in a dependent claim are old and 53 USPQ2d 1769, 1775 (Fed. Cir. 2000). See also well known expedients in the art without the support MPEP § 1216.01. In light of recent Federal Circuit of documentary evidence provided the facts so decisions as discussed below and the substantial noticed are of notorious character and serve only to evidence standard of review now applied to USPTO ª®ll in the gapsº which might exist in the evidentiary Board decisions, the following guidance is provided showing made by the examiner to support a in order to assist the examiners in determining when particular ground of rejection. In re Zurko, 258 F.3d it is appropriate to take of®cial notice of facts 1379, 1385, 59 USPQ2d 1693, 1697 (Fed. Cir. without supporting documentary evidence or to rely 2001); Ahlert, 424 F.2d at 1092, 165 USPQ at 421. on common knowledge in the art in making a rejection, and if such of®cial notice is taken, what It would not be appropriate for the examiner to take evidence is necessary to support the examiner's of®cial notice of facts without citing a prior art conclusion of common knowledge in the art. reference where the facts asserted to be well known are not capable of instant and unquestionable A. Determine When It Is Appropriate To Take Of®cial demonstration as being well-known. For example, Notice Without Documentary Evidence To Support the assertions of technical facts in the areas of esoteric Examiner's Conclusion technology or speci®c knowledge of the prior art must always be supported by citation to some Of®cial notice without documentary evidence to reference work recognized as standard in the support an examiner's conclusion is permissible only pertinent art. In re Ahlert, 424 F.2d at 1091, 165 in some circumstances. While ªof®cial noticeº may USPQ at 420-21. See also In re Grose, 592 F.2d be relied on, these circumstances should be rare 1161, 1167-68, 201 USPQ 57, 63 (CCPA 1979) when an application is under ®nal rejection or action (ª[W]hen the PTO seeks to rely upon a chemical under 37 CFR 1.113. Of®cial notice unsupported by theory, in establishing a prima facie case of documentary evidence should only be taken by the obviousness, it must provide evidentiary support for examiner where the facts asserted to be well-known, the existence and meaning of that theory.º); In re or to be common knowledge in the art are capable Eynde, 480 F.2d 1364, 1370, 178 USPQ 470, of instant and unquestionable demonstration as being 474 (CCPA 1973) (ª[W]e reject the notion that well-known. As noted by the court in In re Ahlert, judicial or administrative notice may be taken of the 424 F.2d 1088, 1091, 165 USPQ 418, 420 (CCPA state of the art. The facts constituting the state of the 1970), the notice of facts beyond the record which art are normally subject to the possibility of rational may be taken by the examiner must be ªcapable of disagreement among reasonable men and are not such instant and unquestionable demonstration as to amenable to the taking of such notice.º). defy disputeº (citing In re Knapp Monarch Co., 296 F.2d 230, 132 USPQ 6 (CCPA 1961)). In Ahlert, It is never appropriate to rely solely on ªcommon the court held that the Board properly took judicial knowledgeº in the art without evidentiary support notice that ªit is old to adjust intensity of a ¯ame in in the record, as the principal evidence upon which accordance with the heat requirement.º See also In a rejection was based. Zurko, 258 F.3d at 1385, 59 re Fox, 471 F.2d 1405, 1407, 176 USPQ 340, 341 USPQ2d at 1697 (ª[T]he Board cannot simply reach (CCPA 1973) (the court took ªjudicial notice of the conclusions based on its own understanding or fact that tape recorders commonly erase tape experienceÐor on its assessment of what would be automatically when new `audio information' is basic knowledge or common sense. Rather, the recorded on a tape which already has a recording on Board must point to some concrete evidence in the itº). In appropriate circumstances, it might be record in support of these ®ndings.º). While the

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court explained that, ªas an administrative tribunal Common Knowledge, the Examiner Must Support the the Board clearly has expertise in the subject matter Finding With Adequate Evidence over which it exercises jurisdiction,º it made clear that such ªexpertise may provide suf®cient support To adequately traverse such a ®nding, an applicant for conclusions [only] as to peripheral issues.º Id. must speci®cally point out the supposed errors in at 1385-86, 59 USPQ2d at 1697. As the court held the examiner's action, which would include stating in Zurko, an assessment of basic knowledge and why the noticed fact is not considered to be common common sense that is not based on any evidence in knowledge or well-known in the art. See 37 CFR the record lacks substantial evidence support. Id. at 1.111(b). See also Chevenard, 139 F.2d at 713, 60 1385, 59 USPQ2d at 1697. USPQ at 241 (ª[I]n the absence of any demand by appellant for the examiner to produce authority for B. If Of®cial Notice Is Taken of a Fact, Unsupported his statement, we will not consider this contention.º). by Documentary Evidence, the Technical Line of A general allegation that the claims de®ne a Reasoning Underlying a Decision To Take Such Notice patentable invention without any reference to the Must Be Clear and Unmistakable examiner's assertion of of®cial notice would be inadequate. If applicant adequately traverses the In certain older cases, of®cial notice has been taken examiner's assertion of of®cial notice, the examiner of a fact that is asserted to be ªcommon knowledgeº must provide documentary evidence in the next without speci®c reliance on documentary evidence Of®ce action if the rejection is to be maintained. See where the fact noticed was readily veri®able, such 37 CFR 1.104(c)(2). See also Zurko, 258 F.3d at as when other references of record supported the 1386, 59 USPQ2d at 1697 (ª[T]he Board [or noticed fact, or where there was nothing of record examiner] must point to some concrete evidence in to contradict it. See In re Soli, 317 F.2d 941, 945-46, the record in support of these ®ndingsº to satisfy the 137 USPQ 797, 800 (CCPA 1963) (accepting the substantial evidence test). If the examiner is relying examiner's assertion that the use of ªa control is on personal knowledge to support the ®nding of standard procedure throughout the entire ®eld of what is known in the art, the examiner must provide bacteriologyº because it was readily veri®able and an af®davit or declaration setting forth speci®c disclosed in references of record not cited by the factual statements and explanation to support the Of®ce); In re Chevenard, 139 F.2d 711, 713, 60 ®nding. See 37 CFR 1.104(d)(2). USPQ 239, 241 (CCPA 1943) (accepting the examiner's ®nding that a brief heating at a higher If applicant does not traverse the examiner's temperature was the equivalent of a longer heating assertion of of®cial notice or applicant's traverse is at a lower temperature where there was nothing in not adequate, the examiner should clearly indicate the record to indicate the contrary and where the in the next Of®ce action that the common knowledge applicant never demanded that the examiner produce or well-known in the art statement is taken to be evidence to support his statement). If such notice is admitted prior art because applicant either failed to taken, the basis for such reasoning must be set forth traverse the examiner's assertion of of®cial notice explicitly. The examiner must provide speci®c or that the traverse was inadequate. If the traverse factual ®ndings predicated on sound technical and was inadequate, the examiner should include an scienti®c reasoning to support his or her conclusion explanation as to why it was inadequate. of common knowledge. See Soli, 317 F.2d at 946, 37 USPQ at 801; Chevenard, 139 F.2d at 713, 60 D. Determine Whether the Next Of®ce Action Should USPQ at 241. The applicant should be presented Be Made Final with the explicit basis on which the examiner regards the matter as subject to of®cial notice so as to If the examiner adds a reference in the next Of®ce adequately traverse the rejection in the next reply action after applicant's rebuttal, and the newly added after the Of®ce action in which the common reference is added only as directly corresponding knowledge statement was made. evidence to support the prior common knowledge ®nding, and it does not result in a new issue or C. If Applicant Challenges a Factual Assertion as Not constitute a new ground of rejection, the Of®ce Properly Of®cially Noticed or Not Properly Based Upon

2100-171 Rev. 07.2015, October 2015 § 2144.04 MANUAL OF PATENT EXAMINING PROCEDURE

action may be made ®nal. If no amendments are bottle, wherein the hollow member and the bottle made to the claims, the examiner must not rely on together give the impression of a human body. any other teachings in the reference if the rejection Appellant argued that certain limitations in the upper is made ®nal. If the newly cited reference is added part of the body, including the arrangement of the for reasons other than to support the prior common arms, were not taught by the prior art. The court knowledge statement and a new ground of rejection found that matters relating to ornamentation only is introduced by the examiner that is not necessitated which have no mechanical function cannot be relied by applicant's amendment of the claims, the rejection upon to patentably distinguish the claimed invention may not be made ®nal. See MPEP § 706.07(a). from the prior art.). But see Ex parte Hilton, 148 USPQ 356 (Bd. App. 1965) (Claims were E. Summary directed to fried potato chips with a speci®ed moisture and fat content, whereas the prior art was Any rejection based on assertions that a fact is directed to french fries having a higher moisture well-known or is common knowledge in the art content. While recognizing that in some cases the without documentary evidence to support the particular shape of a product is of no patentable examiner's conclusion should be judiciously applied. signi®cance, the Board held in this case the shape Furthermore, as noted by the court in Ahlert, any (chips) is important because it results in a product facts so noticed should be of notorious character and which is distinct from the reference product (french serve only to ª®ll in the gapsº in an insubstantial fries).). manner which might exist in the evidentiary showing made by the examiner to support a particular ground II. ELIMINATION OF A STEP OR AN ELEMENT for rejection. It is never appropriate to rely solely on AND ITS FUNCTION common knowledge in the art without evidentiary support in the record as the principal evidence upon A. Omission of an Element and Its Function Is Obvious which a rejection was based. See Zurko, 258 F.3d if the Function of the Element Is Not Desired at 1386, 59 USPQ2d at 1697; Ahlert, 424 F.2d at 1092, 165 USPQ 421. Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for 2144.04 Legal Precedent as Source of inhibiting corrosion on metal surfaces using a Supporting Rationale [R-11.2013] composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed As discussed in MPEP § 2144, if the facts in a prior an anticorrosion composition of epoxy resin, legal decision are suf®ciently similar to those in an hydrocarbon diluent, and polybasic acid salts application under examination, the examiner may wherein said salts were taught to be bene®cial when use the rationale used by the court. Examples employed in a freshwater environment, in view of directed to various common practices which the court secondary references which clearly suggested the has held normally require only ordinary skill in the addition of petroleum sulfonate to corrosion art and hence are considered routine expedients are inhibiting compositions. The Board af®rmed the discussed below. If the applicant has demonstrated rejection, holding that it would have been obvious the criticality of a speci®c limitation, it would not to omit the polybasic acid salts of the primary be appropriate to rely solely on case law as the reference where the function attributed to such salt rationale to support an obviousness rejection. is not desired or required, such as in compositions for providing corrosion resistance in environments I. AESTHETIC DESIGN CHANGES which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1965) (Omission of additional framework and axle 1947) (Claim was directed to an advertising display which served to increase the cargo carrying capacity device comprising a bottle and a hollow member in of prior art mobile ¯uid carrying unit would have the shape of a human ®gure from the waist up which been obvious if this feature was not desired.); and was adapted to ®t over and cover the neck of the

Rev. 07.2015, October 2015 2100-172 PATENTABILITY § 2144.04

In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA a lift truckº where held unpatentable over prior art 1975) (deleting a prior art switch member and lumber packages which could be lifted by hand thereby eliminating its function was an obvious because limitations relating to the size of the package expedient). were not suf®cient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 B. Omission of an Element with Retention of the USPQ 143 (CCPA 1976) (ªmere scaling up of a prior Element©s Function Is an Indicia of Unobviousness art process capable of being scaled up, if such were the case, would not establish patentability in a claim Note that the omission of an element and retention to an old process so scaled.º 531 F.2d at 1053, 189 of its function is an indicia of unobviousness. In USPQ at 148.). re Edge, 359 F.2d 896, 149 USPQ 556 (CCPA 1966) (Claims at issue were directed to a printed sheet In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 having a thin layer of erasable metal bonded directly USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. to the sheet wherein said thin layer obscured the 830, 225 USPQ 232 (1984), the Federal Circuit held original print until removal by erasure. The prior art that, where the only difference between the prior art disclosed a similar printed sheet which further and the claims was a recitation of relative dimensions comprised an intermediate transparent and of the claimed device and a device having the erasure-proof protecting layer which prevented claimed relative dimensions would not perform erasure of the printing when the top layer was erased. differently than the prior art device, the claimed The claims were found unobvious over the prior art device was not patentably distinct from the prior art because the although the transparent layer of the device. prior art was eliminated, the function of the transparent layer was retained since appellant's metal B. Changes in Shape layer could be erased without erasing the printed indicia.). In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the con®guration of the III. AUTOMATING A MANUAL ACTIVITY claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 the art would have found obvious absent persuasive (CCPA 1958) (Appellant argued that claims to a evidence that the particular con®guration of the permanent mold casting apparatus for molding trunk claimed container was signi®cant.). pistons were allowable over the prior art because the claimed invention combined ªold permanent-mold C. Changes in Sequence of Adding Ingredients structures together with a timer and solenoid which automatically actuates the known pressure valve Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) system to release the inner core after a predetermined (Prior art reference disclosing a process of making time has elapsed.º The court held that broadly a laminated sheet wherein a base sheet is ®rst coated providing an automatic or mechanical means to with a metallic ®lm and thereafter impregnated with replace a manual activity which accomplished the a thermosetting material was held to render prima same result is not suf®cient to distinguish over the facie obvious claims directed to a process of making prior art.). a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d IV. CHANGES IN SIZE, SHAPE, OR SEQUENCE 690, 69 USPQ 330 (CCPA 1946) (selection of any OF ADDING INGREDIENTS order of performing process steps is prima facie obvious in the absence of new or unexpected results); A. Changes in Size/Proportion In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA is prima facie obvious.). 1955) (Claims directed to a lumber package ªof appreciable size and weight requiring handling by

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V. MAKING PORTABLE, INTEGRAL, art's] holder to which the cap is applied, it would be SEPARABLE, ADJUSTABLE, OR CONTINUOUS obvious to make the cap removable for that purpose.º). A. Making Portable D. Making Adjustable In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952) (Fact that a claimed device is portable or In re Stevens, 212 F.2d 197, 101 USPQ 284 (CCPA movable is not suf®cient by itself to patentably 1954) (Claims were directed to a handle for a ®shing distinguish over an otherwise old device unless there rod wherein the handle has a longitudinally are new or unexpected results.). adjustable ®nger hook, and the hand grip of the handle connects with the body portion by means of B. Making Integral a universal joint. The court held that adjustability, where needed, is not a patentable advance, and In re Larson, 340 F.2d 965, 968, 144 USPQ 347, because there was an art-recognized need for 349 (CCPA 1965) (A claim to a ¯uid transporting adjustment in a ®shing rod, the substitution of a vehicle was rejected as obvious over a prior art universal joint for the single pivot of the prior art reference which differed from the prior art in would have been obvious.). claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior E. Making Continuous art comprise several parts rigidly secured together as a single unit. The court af®rmed the rejection In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA holding, among other reasons, ªthat the use of a one 1963) (Claim directed to a method of producing a piece construction instead of the structure disclosed cementitious structure wherein a stable air foam is in [the prior art] would be merely a matter of obvious introduced into a slurry of cementitious material engineering choice.º); but see Schenck v. Nortron differed from the prior art only in requiring the Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) addition of the foam to be continuous. The court (Claims were directed to a vibratory testing machine held the claimed continuous operation would have (a hard-bearing wheel balancer) comprising a been obvious in light of the batch process of the prior holding structure, a base structure, and a supporting art.). means which form ªa single integral and gaplessly continuous piece.º Nortron argued that the invention VI. REVERSAL, DUPLICATION, OR is just making integral what had been made in four REARRANGEMENT OF PARTS bolted pieces. The court found this argument unpersuasive and held that the claims were A. Reversal of Parts patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA inventor eliminated the need for dampening via the 1955) (Prior art disclosed a clock ®xed to the one-piece gapless support structure, showing insight stationary steering wheel column of an automobile that was contrary to the understandings and while the gear for winding the clock moves with expectations of the art.). steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an C. Making Separable obvious modi®cation.).

In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, B. Duplication of Parts 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA prior art except that in the prior art the cap is ªpress 1960) (Claims at issue were directed to a water-tight ®ttedº and therefore not manually removable. The masonry structure wherein a water seal of ¯exible court held that ªif it were considered desirable for material ®lls the joints which form between adjacent any reason to obtain access to the end of [the prior pours of concrete. The claimed water seal has a

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ªwebº which lies in the joint, and a plurality of ªribsº of the claimed material or suitable methods of projecting outwardly from each side of the web into obtaining that form or structure. In re Cofer, 354 one of the adjacent concrete slabs. The prior art F.2d 664, 148 USPQ 268 (CCPA 1966) (Claims to disclosed a ¯exible water stop for preventing passage the free-¯owing crystalline form of a compound of water between masses of concrete in the shape of were held unobvious over references disclosing the a plus sign (+). Although the reference did not viscous liquid form of the same compound because disclose a plurality of ribs, the court held that mere the prior art of record did not suggest the claimed duplication of parts has no patentable signi®cance compound in crystalline form or how to obtain such unless a new and unexpected result is produced.). crystals.).

C. Rearrangement of Parts See also Ex parte Stern, 13 USPQ2d 1379 (Bd. Pat. App. & Inter. 1987) (Claims to interleukin-2 (a In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA protein with a molecular weight of over 12,000) 1950) (Claims to a hydraulic power press which read puri®ed to homogeneity were held unpatentable over on the prior art except with regard to the position of references which recognized the desirability of the starting switch were held unpatentable because purifying interleukin-2 to homogeneity in a view of shifting the position of the starting switch would not a reference which taught a method of purifying have modi®ed the operation of the device.); In re proteins having molecular weights in excess of Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) 12,000 to homogeneity wherein the prior art method (the particular placement of a contact in a was similar to the method disclosed by appellant for conductivity measuring device was held to be an purifying interleukin-2). obvious matter of design choice). However, ª[t]he mere fact that a worker in the art could rearrange the 2144.05 Obviousness of Ranges [R-08.2012] parts of the reference device to meet the terms of the claims on appeal is not by itself suf®cient to support See MPEP § 2131.03 for case law pertaining to a ®nding of obviousness. The prior art must provide rejections based on the anticipation of ranges under a motivation or reason for the worker in the art, 35 U.S.C. 102 and 35 U.S.C. 102/103. without the bene®t of appellant's speci®cation, to make the necessary changes in the reference device.º I. OVERLAP OF RANGES Ex parte Chicago Rawhide Mfg. Co., 223 USPQ 351, 353 (Bd. Pat. App. & Inter. 1984). In the case where the claimed ranges ªoverlap or lie inside ranges disclosed by the prior artº a prima VII. PURIFYING AN OLD PRODUCT facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In Pure materials are novel vis-à-vis less pure or re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. impure materials because there is a difference Cir. 1990) (The prior art taught carbon monoxide between pure and impure materials. Therefore, the concentrations of ªabout 1-5%º while the claim was issue is whether claims to a pure material are limited to ªmore than 5%.º The court held that unobvious over the prior art. In re Bergstrom, 427 ªabout 1-5%º allowed for concentrations slightly F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer above 5% thus the ranges overlapped.); In re forms of known products may be patentable, but the Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, mere purity of a product, by itself, does not render 1365-66 (Fed. Cir. 1997) (Claim reciting thickness the product unobvious. of a protective layer as falling within a range of ª50 to 100 Angstromsº considered prima facie obvious Factors to be considered in determining whether a in view of prior art reference teaching that ªfor puri®ed form of an old product is obvious over the suitable protection, the thickness of the protective prior art include whether the claimed chemical layer should be not less than about 10 nm [i.e., 100 compound or composition has the same utility as Angstroms].º The court stated that ªby stating that closely related materials in the prior art, and whether `suitable protection' is provided if the protective the prior art suggests the particular form or structure layer is `about' 100 Angstroms thick, [the prior art

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reference] directly teaches the use of a thickness court further stated that the ªrangeº disclosed in within [applicant's] claimed range.º). Similarly, a multiple prior art patents is ªa distinction without a prima facie case of obviousness exists where the differenceº from previous range cases which claimed ranges and prior art ranges do not overlap involved a range disclosed in a single patent since but are close enough that one skilled in the art would the ªprior art suggested that a larger number of have expected them to have the same properties. elongated grips in the weight plates was bene®cial¼ Titanium Metals Corp. of Amer. v. Banner, 778 F.2d thus plainly suggesting that one skilled in the art 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as look to the range appearing in the prior art.º Id. proper a rejection of a claim directed to an alloy of ªhaving 0.8% nickel, 0.3% molybdenum, up to 0.1% II. OPTIMIZATION OF RANGES iron, balance titaniumº as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% A. Optimization Within Prior Art Conditions or molybdenum, balance titanium and 0.94% nickel, Through Routine Experimentation 0.31% molybdenum, balance titanium.). Generally, differences in concentration or ª[A] prior art reference that discloses a range temperature will not support the patentability of encompassing a somewhat narrower claimed range subject matter encompassed by the prior art unless is suf®cient to establish a prima facie case of there is evidence indicating such concentration or obviousness.º In re Peterson, 315 F.3d 1325, 1330, temperature is critical. ª[W]here the general 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See conditions of a claim are disclosed in the prior art, also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 it is not inventive to discover the optimum or (Fed. Cir. 2005) (claimed alloy held obvious over workable ranges by routine experimentation.º In prior art alloy that taught ranges of weight re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 percentages overlapping, and in most instances (CCPA 1955) (Claimed process which was completely encompassing, claimed ranges; performed at a temperature between 40°C and 80°C furthermore, narrower ranges taught by reference and an acid concentration between 25% and 70% overlapped all but one range in claimed invention). was held to be prima facie obvious over a reference However, if the reference's disclosed range is so process which differed from the claims only in that broad as to encompass a very large number of the reference process was performed at a temperature possible distinct compositions, this might present a of 100°C and an acid concentration of 10%.); see situation analogous to the obviousness of a species also Peterson, 315 F.3d at 1330, 65 USPQ2d at when the prior art broadly discloses a genus. Id. See 1382 (ªThe normal desire of scientists or artisans to also In re Baird, 16 F.3d 380, 29 USPQ2d 1550 improve upon what is already generally known (Fed. Cir. 1994); In re Jones, 958 F.2d 347, 21 provides the motivation to determine where in a USPQ2d 1941 (Fed. Cir. 1992); MPEP § 2144.08. disclosed set of percentage ranges is the optimum combination of percentages.º); In re Hoeschele, 406 A range can be disclosed in multiple prior art F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed references instead of in a single prior art reference elastomeric polyurethanes which fell within the depending on the speci®c facts of the case. Iron broad scope of the references were held to be Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d unpatentable thereover because, among other 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. reasons, there was no evidence of the criticality of 2004). The patent claim at issue was directed to a the claimed ranges of molecular weight or molar weight plate having 3 elongated openings that served proportions.). For more recent cases applying this as handles for transporting the weight plate. Multiple principle, see Merck & Co. Inc. v. Biocraft Lab. prior art patents each disclosed weight plates having Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), 1, 2 or 4 elongated openings. 392 F.3d at 1319, 73 cert. denied, 493 U.S. 975 (1989); In re Kulling, USPQ2d at 1226. The court stated that the claimed 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); weight plate having 3 elongated openings fell within and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 the ªrangeº of the prior art and was thus presumed (Fed. Cir. 1997). obvious. 392 F.3d at 1322, 73 USPQ2d at 1228. The

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B. Only Result-Effective Variables Can Be Optimized invention. ªZehender suggests that there are bene®ts to be derived from keeping the protective layer as A particular parameter must ®rst be recognized as thin as possible, consistent with achieving adequate a result-effective variable, i.e., a variable which protection. A thinner coating reduces light absorption achieves a recognized result, before the and minimizes manufacturing time and expense. determination of the optimum or workable ranges Thus, while Zehender expresses a preference for a of said variable might be characterized as routine thicker protective layer of 200-300 Angstroms, at experimentation. In re Antonie, 559 F.2d 618, 195 the same time it provides the motivation for one of USPQ 6 (CCPA 1977) (The claimed wastewater ordinary skill in the art to focus on thickness levels treatment device had a tank volume to contractor at the bottom of Zehender's `suitable' range- about area of 0.12 gal./sq. ft. The prior art did not 100 Angstroms- and to explore thickness levels recognize that treatment capacity is a function of the below that range. The statement in Zehender that tank volume to contractor ratio, and therefore the `[i]n general, the thickness of the protective layer parameter optimized was not recognized in the art should be not less than about [100 Angstroms]' falls to be a result- effective variable.). See also In far short of the kind of teaching that would re Boesch, 617 F.2d 272, 205 USPQ 215 discourage one of skill in the art from fabricating a (CCPA 1980) (prior art suggested proportional protective layer of 100 Angstroms or less. [W]e are balancing to achieve desired results in the formation therefore `not convinced that there was a suf®cient of an alloy). teaching away in the art to overcome [the] strong case of obviousness' made out by Zehender.º). See III. REBUTTAL OF PRIMA FACIE CASE OF MPEP § 2145, subsection X.D., for a discussion of OBVIOUSNESS ªteaching awayº references.

Applicants can rebut a prima facie case of Applicant can rebut a presumption of obviousness obviousness based on overlapping ranges by showing based on a claimed invention that falls within a prior the criticality of the claimed range. ªThe law is art range by showing ª(1) [t]hat the prior art taught replete with cases in which the difference between away from the claimed invention...or (2) that there the claimed invention and the prior art is some range are new and unexpected results relative to the prior or other variable within the claims. . . . In such a art.º Iron Grip Barbell Co., Inc. v. USA Sports, Inc., situation, the applicant must show that the particular 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. range is critical, generally by showing that the Cir. 2004). The court found that patentee offered claimed range achieves unexpected results relative neither evidence of teaching away of the prior art to the prior art range.º In re Woodruff, 919 F.2d nor new and unexpected results of the claimed 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP invention drawn to a weight plate having 3 elongated § 716.02 - § 716.02(g) for a discussion of criticality handle openings. 392 F.3d at 1323, 73 USPQ2d at and unexpected results. 1229. The court then turned to considering substantial evidence of pertinent secondary factors A prima facie case of obviousness may also be such as commercial success, satisfaction of a rebutted by showing that the art, in any material long-felt need, and copying by others may also respect, teaches away from the claimed invention. support patentability. Id. Nevertheless, the court In re Geisler, 116 F.3d 1465, 1471, 43 USPQ2d found that Iron Grip failed to show evidence of 1362, 1366 (Fed. Cir. 1997) (Applicant argued that commercial success, copying by others, or the prior art taught away from use of a protective satisfaction of a long felt need for the following layer for a re¯ective article having a thickness within reasons: (A) Iron Grip's licensing of its patent to the claimed range of ª50 to 100 Angstroms.º three competitors was insuf®cient to show nexus Speci®cally, a patent to Zehender, which was relied between the ªmerits of the invention and the upon to reject applicant's claim, included a statement licenses,º and thus did not establish secondary that the thickness of the protective layer ªshould be consideration of commercial success; (B) in response not less than about [100 Angstroms].º The court held to Iron Grip's argument that the competitor's that the patent did not teach away from the claimed production of a three-hole plate is evidence of

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copying, the court stated that ª[n]ot every competing the components at issue are functional or mechanical product that falls within the scope of a patent is equivalents. In re Ruff, 256 F.2d 590, 118 USPQ evidence of copyingº since ª[o]therwise every 340 (CCPA 1958) (The mere fact that components infringement suit would automatically con®rm the are claimed as members of a Markush group cannot nonobviousness of the patent;º and (C) although be relied upon to establish the equivalency of these Iron Grip offered as evidence that the absence of the components. However, an applicant's expressed three-grip plate on the market prior to its patent recognition of an art-recognized or obvious showed that the invention was nonobviousness, the equivalent may be used to refute an argument that court stated that ª[a]bsent a showing of a long-felt such equivalency does not exist.); Smith v. Hayashi, need or the failure of others, the mere passage of 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere time without the claimed invention is not evidence fact that phthalocyanine and selenium function as of nonobviousness.º 392 F.3d at 1324-25, equivalent photoconductors in the claimed 73 USPQ2d at 1229-30. environment was not suf®cient to establish that one would have been obvious over the other. However, 2144.06 Art Recognized Equivalence for the there was evidence that both phthalocyanine and Same Purpose [R-08.2012] selenium were known photoconductors in the art of electrophotography. ªThis, in our view, presents I. COMBINING EQUIVALENTS KNOWN FOR strong evidence of obviousness in substituting one THE SAME PURPOSE for the other in an electrophotographic environment as a photoconductor.º 209 USPQ at 759.). ªIt is prima facie obvious to combine two compositions each of which is taught by the prior An express suggestion to substitute one equivalent art to be useful for the same purpose, in order to component or process for another is not necessary form a third composition to be used for the very to render such substitution obvious. In re Fout, 675 same purpose.... [T]he idea of combining them ¯ows F.2d 297, 213 USPQ 532 (CCPA 1982). logically from their having been individually taught in the prior art.º In re Kerkhoven, 626 F.2d 846, 2144.07 Art Recognized Suitability for an 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations Intended Purpose [R-08.2012] omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two The selection of a known material based on its conventional spray-dried detergents were held to be suitability for its intended use supported a prima prima facie obvious.). See also In re Crockett, 279 facie obviousness determination in Sinclair & F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims Carroll Co. v. Interchemical Corp., 325 U.S. 327, directed to a method and material for treating cast 65 USPQ 297 (1945) (Claims to a printing ink iron using a mixture comprising calcium carbide and comprising a solvent having the vapor pressure magnesium oxide were held unpatentable over prior characteristics of butyl carbitol so that the ink would art disclosures that the aforementioned components not dry at room temperature but would dry quickly individually promote the formation of a nodular upon heating were held invalid over a reference structure in cast iron.); and Ex parte Quadranti, teaching a printing ink made with a different solvent 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) that was nonvolatile at room temperature but highly (mixture of two known herbicides held prima facie volatile when heated in view of an article which obvious). taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a II. SUBSTITUTING EQUIVALENTS KNOWN FOR catalog teaching the boiling point and vapor pressure THE SAME PURPOSE characteristics of butyl carbitol. ªReading a list and selecting a known compound to meet known In order to rely on equivalence as a rationale requirements is no more ingenious than selecting supporting an obviousness rejection, the equivalency the last piece to put in the last opening in a jig-saw must be recognized in the prior art, and cannot be puzzle.º 325 U.S. at 335, 65 USPQ at 301.). based on applicant's disclosure or the mere fact that

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See also In re Leshin, 277 F.2d 197, 125 USPQ 416 PERTINENT ART AT THE TIME THE INVENTION (CCPA 1960) (selection of a known plastic to make WAS MADE a container of a type made of plastics prior to the invention was held to be obvious); Ryco, The patentability of a claim to a speci®c compound, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d species, or subgenus embraced by a prior art genus 1323 (Fed. Cir. 1988) (Claimed agricultural bagging should be analyzed no differently than any other machine, which differed from a prior art machine claim for purposes of 35 U.S.C. 103. ªThe section only in that the brake means were hydraulically 103 requirement of unobviousness is no different in operated rather than mechanically operated, was held chemical cases than with respect to other categories to be obvious over the prior art machine in view of of patentable inventions.º In re Papesch, 315 F.2d references which disclosed hydraulic brakes for 381, 385, 137 USPQ 43, 47 (CCPA 1963). A performing the same function, albeit in a different determination of patentability under 35 U.S.C. 103 environment.). should be made upon the facts of the particular case in view of the totality of the circumstances. See, e.g., 2144.08 Obviousness of Species When Prior In re Dillon, 919 F.2d 688, 692-93, 16 USPQ2d Art Teaches Genus [R-07.2015] 1897, 1901 (Fed. Cir. 1990) (en banc). Use of per se rules by Of®ce personnel is improper for determining whether claimed subject matter would [Editor Note: This MPEP section is applicable to have been obvious under 35 U.S.C. 103. See, e.g., applications subject to the ®rst inventor to ®le In re Brouwer, 77 F.3d 422, 425, 37 USPQ2d 1663, (FITF) provisions of the AIA except that the relevant 1666 (Fed. Cir. 1996); In re Ochiai, 71 F.3d 1565, date is the "effective ®ling date" of the claimed 1572, 37 USPQ2d 1127, 1133 (Fed. Cir. 1995); In invention instead of the "time the invention was re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 made," which is only applicable to applications (Fed. Cir. 1994). The fact that a claimed species or subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 subgenus is encompassed by a prior art genus is not (note) and MPEP § 2150 et seq.] suf®cient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 I. EXAMINATION OF CLAIMS DIRECTED TO SPECIES BASED UPON A SINGLE PRIOR ART USPQ2d 1550, 1552 (Fed. Cir. 1994) (ªThe fact that REFERENCE a claimed compound may be encompassed by a disclosed generic formula does not by itself render When a single prior art reference which discloses a that compound obvious.º); In re Jones, 958 F.2d genus encompassing the claimed species or subgenus 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) but does not expressly disclose the particular claimed (Federal Circuit has ªdecline[d] to extract from species or subgenus, Of®ce personnel should attempt Merck [ & Co. v. Biocraft Laboratories Inc., 874 to ®nd additional prior art to show that the F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the differences between the prior art primary reference rule that... regardless of how broad, a disclosure of and the claimed invention as a whole would have a chemical genus renders obvious any species that been obvious. Where such additional prior art is not happens to fall within it.º). found, Of®ce personnel should consider the factors discussed below to determine whether a single A. Establishing a Prima Facie Case of Obviousness reference 35 U.S.C. 103 rejection would be appropriate. A proper obviousness analysis involves a three-step process. First, Of®ce personnel should establish a II. DETERMINE WHETHER THE CLAIMED prima facie case of unpatentability considering the SPECIES OR SUBGENUS WOULD HAVE BEEN factors set out by the Supreme Court in Graham v. OBVIOUS TO ONE OF ORDINARY SKILL IN THE John Deere, 383 U.S. 1, 148 USPQ 459 (1966). See, e.g., In re Bell, 991 F.2d 781, 783, 26 USPQ2d 1529, 1531 (Fed. Cir. 1993) (ªThe PTO bears the burden of establishing a case of prima facie obviousness.º); In re Rijckaert, 9 F.3d 1531, 1532,

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28 USPQ2d 1955, 1956 (Fed. Cir. 1993); In re and any problems alleged to be addressed by the Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, genus; 1444 (Fed. Cir. 1992). Graham at 17-18, 148 USPQ (C) the predictability of the technology; and at 467 requires that to make out a case of obviousness, one must: (D) the number of species encompassed by the genus taking into consideration all of the variables (A) determine the scope and contents of the prior possible. art; 2. Ascertain the Differences Between the Closest (B) ascertain the differences between the prior Disclosed Prior Art Species or Subgenus of Record art and the claims in issue; and the Claimed Species or Subgenus (C) determine the level of ordinary skill in the Once the structure of the disclosed prior art genus pertinent art; and and that of any expressly described species or (D) evaluate any evidence of secondary subgenus within the genus are identi®ed, Of®ce considerations. personnel should compare it to the claimed species or subgenus to determine the differences. Through If a prima facie case is established, the burden shifts this comparison, the closest disclosed species or to applicant to come forward with rebuttal evidence subgenus in the prior art reference should be or argument to overcome the prima facie case. See, identi®ed and compared to that claimed. Of®ce e.g., Bell, 991 F.2d at 783-84, 26 USPQ2d at 1531; personnel should make explicit ®ndings on the Rijckaert, 9 F.3d at 1532, 28 USPQ2d at 1956; similarities and differences between the closest Oetiker, 977 F.2d at 1445, 24 USPQ2d at 1444 . disclosed prior art species or subgenus of record and Finally, Of®ce personnel should evaluate the totality the claimed species or subgenus including ®ndings of the facts and all of the evidence to determine relating to similarity of structure, properties and whether they still support a conclusion that the utilities. In Strato¯ex, Inc. v. Aeroquip Corp., 713 claimed invention would have been obvious to one F.2d 1530, 1537, 218 USPQ 871, 877 (Fed. Cir. of ordinary skill in the art at the time the invention 1983), the court noted that ªthe question under was made. Graham, at 17-18, 148 USPQ at 467. 35 U.S.C. § 103 is not whether the differences [between the claimed invention and the prior art] 1. Determine the Scope and Content of the Prior Art would have been obviousº but ªwhether the claimed invention as a whole would have been obvious.º As an initial matter, Of®ce personnel should (emphasis in original). determine the scope and content of the relevant prior art. Each reference must qualify as prior art under 3. Determine the Level of Skill in the Art 35 U.S.C. 102 (e.g., Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, 1597 Of®ce personnel should evaluate the prior art from (Fed. Cir. 1987) (ªBefore answering Graham's the standpoint of the hypothetical person having `content' inquiry, it must be known whether a patent ordinary skill in the art at the time the claimed or publication is in the prior art under 35 U.S.C. invention was made. See, Ryko Mfg. Co. v. Nu-Star § 102.º)) and should be analogous art. See MPEP § Inc., 950 F.2d 714, 718, 21 USPQ2d 1053, 1057 2141.01(a) . (Fed. Cir. 1991) (ªThe importance of resolving the level of ordinary skill in the art lies in the necessity In the case of a prior art reference disclosing a genus, of maintaining objectivity in the obviousness Of®ce personnel should make ®ndings as to: inquiry.º); Uniroyal Inc. v. Rudkin-Wiley Corp., 837 F.2d 1044, 1050, 5 USPQ2d 1434, 1438 (Fed. (A) the structure of the disclosed prior art genus Cir. 1988) (evidence must be viewed from position and that of any expressly described species or of ordinary skill, not of an expert). In most cases, subgenus within the genus; the only facts of record pertaining to the level of (B) any physical or chemical properties and skill in the art will be found within the prior art utilities disclosed for the genus, as well as any suggested limitations on the usefulness of the genus,

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reference. However, any additional evidence positions, and a large unchanging parent presented by applicant should be evaluated. structural nucleus. With these circumstances in mind, it is our opinion that Karrer has 4. Determine Whether One of Ordinary Skill in the described to those with ordinary skill in this art Art Would Have Been Motivated To Select the each of the various permutations here involved Claimed Species or Subgenus as fully as if he had drawn each structural formula or had written each name. In light of the ®ndings made relating to the three Graham factors, Of®ce personnel should determine whether it would have been obvious to one of Id. (emphasis in original). Accord In re Schaumann, ordinary skill in the relevant art to make the claimed 572 F.2d 312, 316, 197 USPQ 5, 9 (CCPA 1978) invention as a whole, i.e., to select the claimed (prior art genus encompassing claimed species which species or subgenus from the disclosed prior art disclosed preference for lower alkyl secondary genus. To address this key issue, Of®ce personnel amines and properties possessed by the claimed should consider all relevant prior art teachings, compound constituted description of claimed focusing on the following, where present. compound for purposes of pre-AIA 35 U.S.C. 102(b)). C.f., In re Ruschig, 343 F.2d 965, 974, 145 USPQ 274, 282 (CCPA 1965) (Rejection of claimed (a) Consider the Size of the Genus compound in light of prior art genus based on Petering is not appropriate where the prior art does Consider the size of the prior art genus, bearing in not disclose a small recognizable class of compounds mind that size alone cannot support an obviousness with common properties.). rejection. There is no absolute correlation between the size of the prior art genus and a conclusion of (b) Consider the Express Teachings obviousness. See, e.g., Baird, 16 F.3d at 383, 29 USPQ2d at 1552. Thus, the mere fact that a prior art genus contains a small number of members does not If the prior art reference expressly teaches a create a per se rule of obviousness. However, a particular reason to select the claimed species or genus may be so small that, when considered in light subgenus, Of®ce personnel should point out the of the totality of the circumstances, it would express disclosure and explain why it would have anticipate the claimed species or subgenus. For been obvious to one of ordinary skill in the art to example, it has been held that a prior art genus select the claimed invention. An express teaching containing only 20 compounds and a limited number may be based on a statement in the prior art reference of variations in the generic chemical formula such as an art recognized equivalence. For example, inherently anticipated a claimed species within the see Merck & Co. v. Biocraft Labs., 874 F.2d 804, genus because ªone skilled in [the] art would... 807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989) envisage each memberº of the genus. In re (holding claims directed to diuretic compositions Petering, 301 F.2d 676, 681, 133 USPQ 275, comprising a speci®c mixture of amiloride and 280 (CCPA 1962) (emphasis in original). More hydrochlorothiazide were obvious over a prior art speci®cally, the court in Petering stated: reference expressly teaching that amiloride was a pyrazinoylguanidine which could be coadministered with potassium excreting diuretic agents, including A simple calculation will show that, excluding hydrochlorothiazide which was a named example, isomerism within certain of the R groups, the to produce a diuretic with desirable sodium and limited class we ®nd in Karrer contains only potassium eliminating properties). See also, In re 20 compounds. However, we wish to point out Kemps, 97 F.3d 1427, 1430, 40 USPQ2d 1309, 1312 that it is not the mere number of compounds in (Fed. Cir. 1996) (holding it would have been obvious this limited class which is signi®cant here but, to combine teachings of prior art to achieve claimed rather, the total circumstances involved, invention where one reference speci®cally refers to including such factors as the limited number the other). of variations for R, only two alternatives for Y and Z, no alternatives for the other ring

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(c) Consider the Teachings of Structural Similarity proteins only one amino acid is allowed at a given position. For example, the gain or loss of even one Consider any teachings of a ªtypical,º ªpreferred,º methyl group can destabilize the structure if close or ªoptimumº species or subgenus within the packing is required in the interior of domains. James disclosed genus. If such a prior art species or Darnell et al., Molecular Cell Biology 51 (2d ed. subgenus is structurally similar to that claimed, its 1990). disclosure may provide a reason for one of ordinary skill in the art to choose the claimed species or The closer the physical and/or chemical similarities subgenus from the genus, based on the reasonable between the claimed species or subgenus and any expectation that structurally similar species usually exemplary species or subgenus disclosed in the prior have similar properties. See, e.g., Dillon, 919 F.2d art, the greater the expectation that the claimed at 693, 696, 16 USPQ2d at 1901, 1904. See also subject matter will function in an equivalent manner Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214 to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 (ªStructural relationships may provide the requisite USPQ2d at 1904 (and cases cited therein). Cf. Baird, motivation or suggestion to modify known 16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosure compounds to obtain new compounds. For example, of dissimilar species can provide teaching away). a prior art compound may suggest its homologs because homologs often have similar properties and Similarly, consider any teaching or suggestion in the therefore chemists of ordinary skill would ordinarily reference of a preferred species or subgenus that is contemplate making them to try to obtain compounds signi®cantly different in structure from the claimed with improved properties.º). species or subgenus. Such a teaching may weigh against selecting the claimed species or subgenus In making an obviousness determination, Of®ce and thus against a determination of obviousness. personnel should consider the number of variables Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 which must be selected or modi®ed, and the nature (reversing obviousness rejection of species in view and signi®cance of the differences between the prior of large size of genus and disclosed ªoptimumº art and the claimed invention. See, e.g., In re Jones, species which differed greatly from and were more 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. complex than the claimed species); Jones, 958 F.2d Cir. 1992) (reversing obviousness rejection of novel at 350, 21 USPQ2d at 1943 (reversing obviousness dicamba salt with acyclic structure over broad prior rejection of novel dicamba salt with acyclic structure art genus encompassing claimed salt, where over broad prior art genus encompassing claimed disclosed examples of genus were dissimilar in salt, where disclosed examples of genus were structure, lacking an ether linkage or being cyclic); dissimilar in structure, lacking an ether linkage or In re Susi, 440 F.2d 442, 445, 169 USPQ 423, 425 being cyclic). For example, teachings of preferred (CCPA 1971) (the difference from the particularly species of a complex nature within a disclosed genus preferred subgenus of the prior art was a hydroxyl may motivate an artisan of ordinary skill to make group, a difference conceded by applicant ªto be of similar complex species and thus teach away from little importanceº). In the area of biotechnology, an making simple species within the genus. Baird, 16 exempli®ed species may differ from a claimed F.3d at 382, 29 USPQ2d at 1552. See also Jones, species by a conservative substitution (ªthe 958 F.2d at 350, 21 USPQ2d at 1943 (disclosed salts replacement in a protein of one amino acid by of genus held not suf®ciently similar in structure to another, chemically similar, amino acid... [which] render claimed species prima facie obvious). is generally expected to lead to either no change or only a small change in the properties of the protein.º Concepts used to analyze the structural similarity of Dictionary of Biochemistry and Molecular Biology chemical compounds in other types of chemical cases 97 (John Wiley & Sons, 2d ed. 1989)). The effect are equally useful in analyzing genus-species cases. of a conservative substitution on protein function For example, a claimed tetra-orthoester fuel depends on the nature of the substitution and its composition was held to be obvious in light of a location in the chain. Although at some locations a prior art tri-orthoester fuel composition based on conservative substitution may be benign, in some their structural and chemical similarity and similar

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use as fuel additives. Dillon, 919 F.2d at 692-93, discovered property in order for there to be a prima 16 USPQ2d at 1900-02. Likewise, claims to facie case of obviousness. Dillon, 919 F.2d at 697, amitriptyline used as an antidepressant were held 16 USPQ2d at 1904-05 (and cases cited therein). If obvious in light of the structural similarity to the claimed invention and the structurally similar imipramine, a known antidepressant prior art prior art species share any useful property, that compound, where both compounds were tricyclic will generally be suf®cient to motivate an artisan of dibenzo compounds and differed structurally only ordinary skill to make the claimed species, e.g., id. in the replacement of the unsaturated carbon atom For example, based on a ®nding that a tri-orthoester in the center ring of amitriptyline with a nitrogen and a tetra-orthoester behave similarly in certain atom in imipramine. In re Merck & Co., 800 F.2d chemical reactions, it has been held that one of 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. ordinary skill in the relevant art would have been 1986). Other structural similarities have been found motivated to select either structure. 919 F.2d at 692, to support a prima facie case of obviousness. See, 16 USPQ2d at 1900-01. In fact, similar properties e.g., In re May, 574 F.2d 1082, 1093-95, 197 USPQ may normally be presumed when compounds are 601, 610-11 (CCPA 1978) (stereoisomers); In re very close in structure. Dillon, 919 F.2d at 693, 696, Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 16 USPQ2d at 1901, 1904. See also In re Grabiak, (CCPA 1977) (adjacent homologs and structural 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. isomers); In re Hoch, 428 F.2d 1341, 1344, 166 1985) (ªWhen chemical compounds have `very USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); close' structural similarities and similar utilities, In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 without more a prima facie case may be made.º). (CCPA 1963) (omission of methyl group from Thus, evidence of similar properties or evidence of pyrazole ring). Generally, some teaching of a any useful properties disclosed in the prior art that structural similarity will be necessary to suggest would be expected to be shared by the claimed selection of the claimed species or subgenus. Id. invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, (d) Consider the Teachings of Similar Properties or 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Uses Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, Consider the properties and utilities of the 1016, 173 USPQ 560, 562 (CCPA 1972). structurally similar prior art species or subgenus. It is the properties and utilities that provide real world (e) Consider the Predictability of the Technology motivation for a person of ordinary skill to make species structurally similar to those in the prior art. Consider the predictability of the technology. See, Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In re e.g., Dillon, 919 F.2d at 692-97, 16 USPQ2d at Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 1901-05; In re Grabiak, 769 F.2d 729, 732-33, 226 (CCPA 1971). Conversely, lack of any known useful USPQ 870, 872 (Fed. Cir. 1985). If the technology properties weighs against a ®nding of motivation to is unpredictable, it is less likely that structurally make or select a species or subgenus. In re Albrecht, similar species will render a claimed species obvious 514 F.2d 1389, 1392, 1395-96, 185 USPQ 585, 587, because it may not be reasonable to infer that they 590 (CCPA 1975) (The prior art compound so would share similar properties. See, e.g. , In re May, irritated the skin that it could not be regarded as 574 F.2d 1082, 1094, 197 USPQ 601, 611 (CCPA useful for the disclosed anesthetic purpose, and 1978) (prima facie obviousness of claimed analgesic therefore a person skilled in the art would not have compound based on structurally similar prior art been motivated to make related compounds.); isomer was rebutted with evidence demonstrating Stemniski, 444 F.2d at 586, 170 USPQ at 348 (close that analgesia and addiction properties could not be structural similarity alone is not suf®cient to create reliably predicted on the basis of chemical structure); a prima facie case of obviousness when the In re Schechter, 205 F.2d 185, 191, 98 USPQ 144, reference compounds lack utility, and thus there is 150 (CCPA 1953) (unpredictability in the insecticide no motivation to make related compounds.). ®eld, with homologs, isomers and analogs of known However, the prior art need not disclose a newly effective insecticides having proven ineffective as

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insecticides, was considered as a factor weighing ordinary skill in the relevant art at the time the against a conclusion of obviousness of the claimed invention was made. compounds). However, obviousness does not require absolute predictability, only a reasonable expectation 2144.09 Close Structural Similarity Between of success, i.e., a reasonable expectation of obtaining Chemical Compounds (Homologs, Analogues, similar properties. See , e.g. , In re O'Farrell, 853 Isomers) [R-08.2012] F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). [Editor Note: This MPEP section is applicable to applications subject to the ®rst inventor to ®le (f) Consider Any Other Teaching To Support the (FITF) provisions of the AIA except that the relevant Selection of the Species or Subgenus date is the "effective ®ling date" of the claimed invention instead of the "time the invention was The categories of relevant teachings enumerated made," which is only applicable to applications above are those most frequently encountered in a subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 genus-species case, but they are not exclusive. Of®ce (note) and MPEP § 2150 et seq.] personnel should consider the totality of the evidence in each case. In unusual cases, there may be other I. REJECTION BASED ON CLOSE STRUCTURAL relevant teachings suf®cient to support the selection SIMILARITY IS FOUNDED ON THE of the species or subgenus and, therefore, a EXPECTATION THAT COMPOUNDS SIMILAR conclusion of obviousness. IN STRUCTURE WILL HAVE SIMILAR PROPERTIES 5. Make Express Fact-Findings and Determine Whether They Support a Prima Facie Case of A prima facie case of obviousness may be made Obviousness when chemical compounds have very close structural similarities and similar utilities. ªAn obviousness Based on the evidence as a whole (In re Bell, 991 rejection based on similarity in chemical structure F.2d 781,784, 26 USPQ2d 1529, 1531 (Fed. Cir. and function entails the motivation of one skilled in 1993); In re Kulling, 897 F.2d 1147, 1149, the art to make a claimed compound, in the 14 USPQ2d 1056, 1057 (Fed. Cir. 1990)), Of®ce expectation that compounds similar in structure will personnel should make express fact-®ndings relating have similar properties.º In re Payne, 606 F.2d 303, to the Graham factors, focusing primarily on the 313, 203 USPQ 245, 254 (CCPA 1979). See In prior art teachings discussed above. The fact-®ndings re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA should speci®cally articulate what teachings or 1963) (discussed in more detail below) and In suggestions in the prior art would have motivated re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. one of ordinary skill in the art to select the claimed 1991) (discussed below and in MPEP § 2144) for species or subgenus. Kulling, 897 F.2d at 1149, 14 an extensive review of the case law pertaining to USPQ2d at 1058; Panduit Corp. v. Dennison Mfg. obviousness based on close structural similarity of Co., 810 F.2d 1561, 1579 n.42, 1 USQP2d 1593, chemical compounds. See also MPEP § 2144.08, 1606 n.42 (Fed. Cir. 1987). Thereafter, it should be subsection II.A.4.(c). determined whether these ®ndings, considered as a whole, support a prima facie case that the claimed II. HOMOLOGY AND ISOMERISM ARE FACTS invention would have been obvious to one of WHICH MUST BE CONSIDERED WITH ALL OTHER RELEVANT FACTS IN DETERMINING OBVIOUSNESS

Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2-

Rev. 07.2015, October 2015 2100-184 PATENTABILITY § 2144.09

groups) are generally of suf®ciently close structural art compounds were both directed to heterocyclic similarity that there is a presumed expectation that carbamoyloximino compounds having pesticidal such compounds possess similar properties. In activity. The only structural difference between the re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA claimed and prior art compounds was that the ring 1977). See also In re May, 574 F.2d 1082, 197 structures of the claimed compounds had two carbon USPQ 601 (CCPA 1978) (stereoisomers prima facie atoms between two sulfur atoms whereas the prior obvious). art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that Isomers having the same empirical formula but although the prior art compounds were not true different structures are not necessarily considered homologs or isomers of the claimed compounds, the equivalent by chemists skilled in the art and therefore similarity between the chemical structures and are not necessarily suggestive of each other. Ex properties is suf®ciently close that one of ordinary parte Mowry, 91 USPQ 219 (Bd. App. 1950) skill in the art would have been motivated to make (claimed cyclohexylstyrene not prima facie obvious the claimed compounds in searching for new over prior art isohexylstyrene). Similarly, homologs pesticides.). which are far removed from adjacent homologs may not be expected to have similar properties. In See also In re Mayne, 104 F.3d 1339, 41 USPQ2d re Mills, 281 F.2d 218, 126 USPQ 513 (CCPA 1960) 1451 (Fed. Cir. 1997) (claimed protein was held to (prior art disclosure of C8 to C12 alkyl sulfates was be obvious in light of structural similarities to the not suf®cient to render prima facie obvious claimed prior art, including known structural similarity of C1 alkyl sulfate). Ile and Lev); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (claimed and prior art compounds used in a method of treating Homology and isomerism involve close structural depression would have been expected to have similar similarity which must be considered with all other activity because the structural difference between relevant facts in determining the issue of the compounds involved a known bioisosteric obviousness. In re Mills, 281 F.2d 218, 126 USPQ replacement) (see MPEP § 2144.08, subsection 513 (CCPA 1960); In re Wiechert, 370 F.2d 927, II.A.4(c) for a more detailed discussion of the facts 152 USPQ 247 (CCPA 1967). Homology should not in the Mayne and Merck cases); In re Dillon, 919 be automatically equated with prima facie F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) (The obviousness because the claimed invention and the tri-orthoester fuel compositions of the prior art and prior art must each be viewed ªas a whole.º In re the claimed tetra-orthoester fuel compositions would Langer, 465 F.2d 896, 175 USPQ 169 (CCPA 1972) have been expected to have similar properties based (Claims to a polymerization process using a sterically on close structural and chemical similarity between hindered amine were held unobvious over a similar the orthoesters and the fact that both the prior art prior art process because the prior art disclosed a and applicant used the orthoesters as fuel additives.) large number of unhindered amines and only one (See MPEP § 2144 for a more detailed discussion sterically hindered amine (which differed from a of the facts in the Dillon case.). claimed amine by 3 carbon atoms), and therefore the reference as a whole did not apprise the ordinary artisan of the signi®cance of hindered amines as a Compare In re Grabiak, 769 F.2d 729, 226 USPQ class.). 871 (Fed. Cir. 1985) (substitution of a thioester group for an ester group in an herbicidal safener compound was not suggested by the prior art); In III. PRESENCE OF A TRUE HOMOLOGOUS OR ISOMERIC RELATIONSHIP IS NOT re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. CONTROLLING 1993) (The established relationship between a nucleic acid and the protein it encodes in the genetic Prior art structures do not have to be true homologs code does not render a gene prima facie obvious or isomers to render structurally similar compounds over its corresponding protein in the same way that prima facie obvious. In re Payne, 606 F.2d 303, closely related structures in chemistry may create a 203 USPQ 245 (CCPA 1979) (Claimed and prior prima facie case because there are a vast number

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of nucleotide sequences that might encode for a and the overall logic of the rejection.º Ex parte speci®c protein as a result of degeneracy in the Goldgaber, 41 USPQ2d 1172, 1176 (Bd. Pat. App. genetic code (i.e., the fact that most amino acids are & Inter. 1996). speci®ed by more than one nucleotide sequence or codon).); In re Deuel, 51 F.3d 1552, 1558-59, 34 V. PRESUMPTION OF OBVIOUSNESS BASED ON USPQ2d 1210, 1215 (Fed. Cir. 1995) (ªA prior art STRUCTURAL SIMILARITY IS OVERCOME disclosure of the amino acid sequence of a protein WHERE THERE IS NO REASONABLE does not necessarily render particular DNA EXPECTATION OF SIMILAR PROPERTIES molecules encoding the protein obvious because the redundancy of the genetic code permits one to The presumption of obviousness based on a reference hypothesize an enormous number of DNA sequences disclosing structurally similar compounds may be coding for the protein.º The existence of a general overcome where there is evidence showing there is method of gene cloning in the prior art is not no reasonable expectation of similar properties in suf®cient, without more, to render obvious a structurally similar compounds. In re May, 574 F.2d particular cDNA molecule.). 1082, 197 USPQ 601 (CCPA 1978) (appellant produced suf®cient evidence to establish a IV. PRESENCE OR ABSENCE OF PRIOR ART substantial degree of unpredictability in the pertinent SUGGESTION OF METHOD OF MAKING A art area, and thereby rebutted the presumption that CLAIMED COMPOUND MAY BE RELEVANT IN structurally similar compounds have similar DETERMINING PRIMA FACIE OBVIOUSNESS properties); In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953). See also Ex parte Blattner, 2 ª[T]he presenceÐor absenceÐof a suitably USPQ2d 2047 (Bd. Pat. App. & Inter. 1987) (Claims operative, obvious process for making a composition directed to compounds containing a 7-membered of matter may have an ultimate bearing on whether ring were rejected as prima facie obvious over a that composition is obviousÐor nonobviousÐunder reference which taught 5- and 6-membered ring 35 U.S.C. 103.º In re Maloney, 411 F.2d 1321, homologs of the claimed compounds. The Board 1323, 162 USPQ 98, 100 (CCPA 1969). reversed the rejection because the prior art taught that the compounds containing a 5-membered ring ª[I]f the prior art of record fails to disclose or render possessed the opposite utility of the compounds obvious a method for making a claimed compound, containing the 6-membered ring, undermining the at the time the invention was made, it may not be examiner's asserted prima facie case arising from legally concluded that the compound itself is in the an expectation of similar results in the claimed possession of the public. In this context, we say that compounds which contain a 7-membered ring.). the absence of a known or obvious process for making the claimed compounds overcomes a VI. IF PRIOR ART COMPOUNDS HAVE NO presumption that the compounds are obvious, based UTILITY, OR UTILITY ONLY AS on the close relationships between their structures INTERMEDIATES, CLAIMED STRUCTURALLY and those of prior art compounds.º In re Hoeksema, SIMILAR COMPOUNDS MAY NOT BE PRIMA 399 F.2d 269, 274-75, 158 USPQ 597, 601 (CCPA FACIE OBVIOUS OVER THE PRIOR ART 1968). If the prior art does not teach any speci®c or signi®cant utility for the disclosed compounds, then See In re Payne, 606 F.2d 303, 203 USPQ 245 the prior art is unlikely to render structurally similar (CCPA 1979) for a general discussion of claims prima facie obvious in the absence of any circumstances under which the prior art suggests reason for one of ordinary skill in the art to make methods for making novel compounds which are of the reference compounds or any structurally related close structural similarity to compounds known in compounds. In re Stemniski, 444 F.2d 581, the prior art. It may be proper to apply ªmethodology 170 USPQ 343 (CCPA 1971). in rejecting product claims under 35 U.S.C. 103, depending on the particular facts of the case, the manner and context in which methodology applies, See also In re Albrecht, 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA 1975) (prior art reference

Rev. 07.2015, October 2015 2100-186 PATENTABILITY § 2145

studied the local anesthetic activity of various See MPEP § 716.02 - § 716.02(g) for a discussion compounds, and taught that compounds structurally of evidence alleging unexpectedly advantageous or similar to those claimed were irritating to human superior results. skin and therefore ªcannot be regarded as useful anesthetics.º 514 F.2d at 1393, 185 USPQ at 587). 2145 Consideration of Applicant's Rebuttal Arguments [R-08.2012] Similarly, if the prior art merely discloses compounds as intermediates in the production of a [Editor Note: This MPEP section is applicable to ®nal product, one of ordinary skill in the art would applications subject to the ®rst inventor to ®le not ordinarily stop the reference synthesis and (FITF) provisions of the AIA except that the relevant investigate the intermediate compounds with an date is the "effective ®ling date" of the claimed expectation of arriving at claimed compounds which invention instead of the "time the invention was have different uses. In re Lalu, 747 F.2d 703, made," which is only applicable to applications 223 USPQ 1257 (Fed. Cir. 1984). subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP § 2150 et seq.] VII. PRIMA FACIE CASE REBUTTABLE BY EVIDENCE OF SUPERIOR OR UNEXPECTED If a prima facie case of obviousness is established, RESULTS the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima A prima facie case of obviousness based on facie case. See, e.g., In re Dillon, 919 F.2d 688, structural similarity is rebuttable by proof that the 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990). claimed compounds possess unexpectedly Rebuttal evidence and arguments can be presented advantageous or superior properties. In re Papesch, in the speci®cation, In re Soni, 54 F.3d 746, 750, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (af®davit 34 USPQ2d 1684, 1687 (Fed. Cir. 1995), by counsel, evidence which showed that claimed triethylated In re Chu, 66 F.3d 292, 299, 36 USPQ2d 1089, compounds possessed anti-in¯ammatory activity 1094-95 (Fed. Cir. 1995), or by way of an af®davit whereas prior art trimethylated compounds did not or declaration under 37 CFR 1.132, e.g., Soni, 54 was suf®cient to overcome obviousness rejection F.3d at 750, 34 USPQ2d at 1687; In re Piasecki, based on the homologous relationship between the 745 F.2d 1468, 1474, 223 USPQ 785, 789-90 (Fed. prior art and claimed compounds); In re Wiechert, Cir. 1984). However, arguments of counsel cannot 370 F.2d 927, 152 USPQ 247 (CCPA 1967) (a 7-fold take the place of factually supported objective improvement of activity over the prior art held evidence. See, e.g., In re Huang, 100 F.3d 135, suf®cient to rebut prima facie obviousness based 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); on close structural similarity). In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). However, a claimed compound may be obvious because it was suggested by, or structurally similar Of®ce personnel should consider all rebuttal to, a prior art compound even though a particular arguments and evidence presented by applicants. bene®t of the claimed compound asserted by See, e.g., Soni, 54 F.3d at 750, 34 USPQ2d at 1687 patentee is not expressly disclosed in the prior art. (error not to consider evidence presented in the It is the differences in fact in their respective speci®cation). C.f., In re Alton, 76 F.3d 1168, 37 properties which are determinative of USPQ2d 1578 (Fed. Cir. 1996) (error not to consider nonobviousness. If the prior art compound does in factual evidence submitted to counter a 35 U.S.C. fact possess a particular bene®t, even though the 112 rejection); In re Beattie, 974 F.2d 1309, 1313, bene®t is not recognized in the prior art, applicant's 24 USPQ2d 1040, 1042-43 (Fed. Cir. 1992) (Of®ce recognition of the bene®t is not in itself suf®cient personnel should consider declarations from those to distinguish the claimed compound from the prior skilled in the art praising the claimed invention and art. In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 opining that the art teaches away from the (Fed. Cir. 1991). invention.); Piasecki, 745 F.2d at 1472, 223 USPQ at 788 (ª[Rebuttal evidence] may relate to any of

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the Graham factors including the so-called making the compound, which would preclude a secondary considerations.º). conclusion of obviousness of the compound. A conclusion of obviousness requires that the Rebuttal evidence may include evidence of reference(s) relied upon be enabling in that it put the ªsecondary considerations,º such as ªcommercial public in possession of the claimed invention. The success, long felt but unsolved needs, [and] failure court in In re Hoeksema, 399 F.2d 269, 274, of others.º Graham v. John Deere Co., 383 U.S. 1, 158 USPQ 596, 601 (CCPA 1968), stated: 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. Thus, upon careful reconsideration it is our 1984) (commercial success). Rebuttal evidence may view that if the prior art of record fails to also include evidence that the claimed invention disclose or render obvious a method for making yields unexpectedly improved properties or a claimed compound, at the time the invention properties not present in the prior art. Rebuttal was made, it may not be legally concluded that evidence may consist of a showing that the claimed the compound itself is in the possession of the compound possesses unexpected properties. Dillon, public. [footnote omitted.] In this context, we 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing say that the absence of a known or obvious of unexpected results must be based on evidence, process for making the claimed compounds not argument or speculation. In re Mayne, 104 F.3d overcomes a presumption that the compounds 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. are obvious, based on close relationships Cir. 1997) (conclusory statements that claimed between their structures and those of prior art compound possesses unusually low immune response compounds. or unexpected biological activity that is unsupported by comparative data held insuf®cient to overcome The Hoeksema court further noted that once a prima prima facie case of obviousness). Rebuttal evidence facie case of obviousness is made by the PTO may include evidence that the claimed invention was through citation of references, the burden is on the copied by others. See, e.g., In re GPAC, 57 F.3d applicant to produce contrary evidence establishing 1573, 1580, 35 USPQ2d 1116, 1121 (Fed. Cir. that the reference being relied on would not enable 1995); Hybritech Inc. v. Monoclonal Antibodies, a skilled artisan to produce the different compounds 802 F.2d 1367, 1380, 231 USPQ 81, 90 (Fed. Cir. claimed. Id. at 274-75, 158 USPQ at 601. See also 1986). It may also include evidence of the state of Ashland Oil, Inc. v. Delta Resins & Refractories, the art, the level of skill in the art, and the beliefs of Inc., 776 F.2d 281, 295, 297, 227 USPQ 657, 666, those skilled in the art. See, e.g., In re Oelrich, 579 667 (Fed. Cir. 1985) (citing Hoeksema for the F.2d 86, 91-92, 198 USPQ 210, 214 (CCPA 1978) proposition above); In re Grose, 592 F.2d 1161, (Expert opinions regarding the level of skill in the 1168, 201 USPQ 57, 63-64 (CCPA 1979) (ªOne of art were probative of the Nonobviousness of the the assumptions underlying a prima facie claimed invention.); Piasecki, 745 F.2d at 1471, obviousness rejection based upon a structural 1473-74, 223 USPQ at 790 (Evidence of relationship between compounds, such as adjacent nontechnological nature is pertinent to the conclusion homologs, is that a method disclosed for producing of obviousness. The declarations of those skilled in one would provide those skilled in the art with a the art regarding the need for the invention and its method for producing the other... Failure of the prior reception by the art were improperly discounted by art to disclose or render obvious a method for making the Board.); Beattie, 974 F.2d at 1313, 24 USPQ2d any composition of matter, whether a compound or at 1042-43 (Seven declarations provided by music a mixture of compounds like a zeolite, precludes a teachers opining that the art teaches away from the conclusion that the composition would have been claimed invention must be considered, but were not obvious.º). probative because they did not contain facts and did not deal with the speci®c prior art that was the subject of the rejection.). For example, rebuttal Consideration of rebuttal evidence and arguments evidence may include a showing that the prior art requires Of®ce personnel to weigh the proffered fails to disclose or render obvious a method for evidence and arguments. Of®ce personnel should avoid giving evidence no weight, except in rare

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circumstances. Id. See also In re Alton, 76 F.3d 646, 2 USPQ2d 1437, 1439 (Fed. Cir. 1987). 1168, 1174-75, 37 USPQ2d 1578, 1582-83 (Fed. Evidence that the compound or composition Cir. 1996). However, to be entitled to substantial possesses superior and unexpected properties in one weight, the applicant should establish a nexus of a spectrum of common properties can be suf®cient between the rebuttal evidence and the claimed to rebut a prima facie case of obviousness. Id. invention, i.e., objective evidence of nonobviousness must be attributable to the claimed invention. The For example, a showing of unexpected results for a Federal Circuit has acknowledged that applicant single member of a claimed subgenus, or a narrow bears the burden of establishing nexus, stating: portion of a claimed range would be suf®cient to rebut a prima facie case of obviousness if a skilled In the ex parte process of examining a patent artisan ªcould ascertain a trend in the exempli®ed application, however, the PTO lacks the means data that would allow him to reasonably extend the or resources to gather evidence which supports probative value thereof.º In re Clemens, 622 F.2d or refutes the applicant's assertion that the sales 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) constitute commercial success. C.f. Ex parte (Evidence of the unobviousness of a broad range Remark, 15 USPQ2d 1498, 1503 ([BPAI] 1990) can be proven by a narrower range when one skilled (evidentiary routine of shifting burdens in civil in the art could ascertain a trend that would allow proceedings inappropriate in ex parte him to reasonably extend the probative value prosecution proceedings because examiner has thereof.). But see, Grasselli, 713 F.2d at 743, 218 no available means for adducing evidence). USPQ at 778 (evidence of superior properties for Consequently, the PTO must rely upon the sodium containing composition insuf®cient to applicant to provide hard evidence of establish the non-obviousness of broad claims for a commercial success. catalyst with ªan alkali metalº where it was well known in the catalyst art that different alkali metals were not interchangeable and applicant had shown In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d unexpected results only for sodium containing 1685, 1689 (Fed. Cir. 1996). See also GPAC, 57 materials); In re Green®eld, 571 F.2d 1185, 1189, F.3d at 1580, 35 USPQ2d at 1121; In re Paulsen, 197 USPQ 227, 230 (CCPA 1978) (evidence of 30 F.3d 1475, 1482, 31 USPQ2d 1671, 1676 (Fed. superior properties in one species insuf®cient to Cir. 1994) (Evidence of commercial success of establish the nonobviousness of a subgenus articles not covered by the claims subject to the 35 containing hundreds of compounds); In re Lindner, U.S.C. 103 rejection was not probative of 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA nonobviousness.). Additionally, the evidence must 1972) (one test not suf®cient where there was no be reasonably commensurate in scope with the adequate basis for concluding the other claimed claimed invention. See, e.g., In re Kulling, 897 F.2d compounds would behave the same way). However, 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. an exemplary showing may be suf®cient to establish 1990); In re Grasselli, 713 F.2d 731, 743, 218 a reasonable correlation between the showing and USPQ 769, 777 (Fed. Cir. 1983). In re Soni, 54 F.3d the entire scope of the claim, when viewed by a 746, 34 USPQ2d 1684 (Fed. Cir. 1995) does not skilled artisan. See, e.g., Chupp, 816 F.2d at 646, 2 change this analysis. In Soni, the court declined to USPQ2d at 1439; Clemens, 622 F.2d at 1036, 206 consider the Of®ce's argument that the evidence of USPQ at 296. On the other hand, evidence of an nonobviousness was not commensurate in scope unexpected property may not be suf®cient regardless with the claim because it had not been raised by the of the scope of the showing. Usually, a showing of examiner Id. 54 F.3d at 751, 34 USPQ2d at 1688. unexpected results is suf®cient to overcome a prima facie case of obviousness. See, e.g., In re Albrecht, When considering whether proffered evidence is 514 F.2d 1389, 1396, 185 USPQ 585, 590 (CCPA commensurate in scope with the claimed invention, 1975). However, where the claims are not limited Of®ce personnel should not require the applicant to to a particular use, and where the prior art provides show unexpected results over the entire range of other motivation to select a particular species or properties possessed by a chemical compound or subgenus, a showing of a new use may not be composition. See, e.g., In re Chupp, 816 F.2d 643,

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suf®cient to confer patentability. See Dillon, 919 The following cases exemplify the continued F.2d at 692, 16 USPQ2d at 1900-01. Accordingly, application of the principle that when evidence has each case should be evaluated individually based on been presented to rebut an obviousness rejection, it the totality of the circumstances. should not be evaluated simply for its ªknockdownº value. Rather, all evidence must be reweighed to Evidence pertaining to secondary considerations determine whether the claims are nonobvious. must be taken into account whenever present; Example 1: however, it does not necessarily control the obviousness conclusion. See, e.g., P®zer, Inc. v. The claims at issue in PharmaStem Therapeutics, Inc. v. Viacell, Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d Inc., 491 F.3d 1342, 83 USPQ2d 1289 (Fed. Cir. 2007), were 1321, 1339 (Fed. Cir. 2007) (ªthe record establish directed to compositions comprising hematopoietic stem cells from umbilical cord or placental blood, and to methods of using [ed] such a strong case of obviousnessº that allegedly such compositions for treatment of blood and immune system unexpectedly superior results were ultimately disorders. The composition claims required that the stem cells insuf®cient to overcome obviousness conclusion); be present in an amount suf®cient to effect hematopoietic Leapfrog Enterprises Inc. v. Fisher-Price Inc., 485 reconstitution when administered to a human adult. The trial court had found that PharmaStem's patents were infringed and F.3d 1157, 1162, 82 USPQ2d 1687, 1692 (Fed. Cir. not invalid on obviousness or other grounds. On appeal, the 2007) (ªgiven the strength of the prima facie Federal Circuit reversed the district court, determining that the obviousness showing, the evidence on secondary claims were invalid for obviousness. considerations was inadequate to overcome a ®nal conclusionº of obviousness); and Newell Cos., Inc. The Federal Circuit discussed the evidence presented at trial. It v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d pointed out that the patentee, PharmaStem, had not invented an entirely new procedure or new composition. Rather, 1417, 1426 (Fed. Cir. 1988). Of®ce personnel should PharmaStem's own speci®cation acknowledged that it was not evaluate rebuttal evidence for its ªknockdownº already known in the prior art that umbilical cord and placental value against the prima facie case, Piasecki, 745 blood-based compositions contained hematopoietic stem cells, F.2d at 1473, 223 USPQ at 788, or summarily and that hematopoietic stem cells were useful for the purpose dismiss it as not compelling or insuf®cient. If the of hematopoietic reconstitution. PharmaStem's contribution was to provide experimental proof that umbilical cord and placental evidence is deemed insuf®cient to rebut the prima blood could be used to effect hematopoietic reconstitution in facie case of obviousness, Of®ce personnel should mice. By extrapolation, one of ordinary skill in the art would speci®cally set forth the facts and reasoning that have expected this reconstitution method to work in humans as justify this conclusion. See MPEP § 716 - § 716.10 well. for additional information pertaining to the evaluation of rebuttal evidence submitted under 37 The court rejected PharmaStem's expert testimony that hematopoietic stem cells had not been proved to exist in cord CFR 1.132. blood prior to the experiments described in PharmaStem's patents. The court explained that the expert testimony was Many basic approaches that a practitioner may use contrary to the inventors' admissions in the speci®cation, as to demonstrate nonobviousness also continue to well as prior art teachings that disclosed stem cells in cord blood. In this case, PharmaStem's evidence of nonobviousness was apply in the post- KSR era. Since it is now clear that outweighed by contradictory evidence. a strict teaching-suggestion-motivation approach is not the only way to establish a prima facie case of Despite PharmaStem's useful experimental validation of obviousness, it is true that practitioners have been hematopoietic reconstitution using hematopoietic stem cells required to shift the emphasis of their from umbilical cord and placental blood, the Federal Circuit nonobviousness arguments to a certain degree. found that the claims at issue would have been obvious. There had been ample suggestion in the prior art that the claimed However, familiar lines of argument still apply, method would have worked. Absolute predictability is not a including teaching away from the claimed invention necessary prerequisite to a case of obviousness. Rather, a degree by the prior art, lack of a reasonable expectation of of predictability that one of ordinary skill would have found to success, and unexpected results. Indeed, they may be reasonable is suf®cient. The Federal Circuit concluded that ª[g]ood science and useful contributions do not necessarily have even taken on added importance in view of the result in patentability.º Id. at 1364, 83 USPQ2d at 1304. recognition in KSR of a variety of possible rationales.

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Example 2: protective covering for the portion of a hearing aid that is It was found to be an error in In re Sullivan, 498 F.3d 1345, 84 inserted into the ear canal. The covering was such that it could USPQ2d 1034 (Fed. Cir. 2007), for the Board to fail to consider be readily replaced by a user as needed. evidence submitted to rebut a prima facie case of obviousness. At the district court, Shure had argued that Hearing Components' The claimed invention was directed to an antivenom composition patents were obvious over one or more of three different comprising F(ab) fragments used to treat venomous rattlesnake combinations of prior art references. The jury disagreed, and bites. The composition was created from antibody molecules determined that the claims were nonobvious. The district court that include three fragments, F(ab)2, F(ab) and F(c), which have upheld the jury verdict, stating that in view of the con¯icting separate properties and utilities. There have been commercially evidence presented by the parties as to the teachings of the available antivenom products that consisted of whole antibodies references, motivation to combine, and secondary considerations, and F(ab)2 fragments, but researchers had not experimented the nonobviousness verdict was suf®ciently grounded in the with antivenoms containing only F(ab) fragments because it evidence. was believed that their unique properties would prevent them from decreasing the toxicity of snake venom. The inventor, Shure appealed to the Federal Circuit, but the Federal Circuit Sullivan, discovered that F(ab) fragments are effective at agreed with the district court that the jury's nonobviousness neutralizing the lethality of rattlesnake venom, while reducing verdict had been supported by substantial evidence. Although the occurrence of adverse immune reactions in humans. On Shure had argued before the jury that the Carlisle reference appeal of the examiner's rejection, the Board held that the claim taught an ear piece positioned inside the ear canal, Hearing was obvious because all the elements of the claimed composition Components' credible witness countered that only the molded were accounted for in the prior art, and that the composition duct and not the ear piece itself was taught by Carlisle as being taught by that prior art would have been expected by a person inside the ear canal. On the issue of combining references, of ordinary skill in the art at the time the invention was made Shure's witness had given testimony described as ªrather sparse, to neutralize the lethality of the venom of a rattlesnake. and lacking in speci®c details.º Id. at 1364, 94 USPQ2d at 1397. In contradistinction, Hearing Components' witness Rebuttal evidence had not been considered by the Board because ªdescribed particular reasons why one skilled in the art would it considered the evidence to relate to the intended use of the not have been motivated to combine the references.º Id. Finally, claimed composition as an antivenom, rather than the as to secondary considerations, the Federal Circuit determined composition itself. Appellant successfully argued that even if that Hearing Components had shown a nexus between the the Board had shown a prima facie case of obviousness, the commercial success of its product and the patent by providing extensive rebuttal evidence must be considered. The evidence evidence that ªthe licensing fee for a covered product was more included three expert declarations submitted to show that the than cut in half immediately upon expirationº of the patent. prior art taught away from the claimed invention, an unexpected property or result from the use of F(ab) fragment antivenom, Although the Hearing Components case involves substantial and why those having ordinary skill in the art expected evidence of nonobviousness in a jury verdict, it is nevertheless antivenoms comprising F(ab) fragments to fail. The declarations instructive for Of®ce personnel on the matter of weighing related to more than the use of the claimed composition. While evidence. Of®ce personnel routinely must consider evidence in a statement of intended use may not render a known composition the form of prior art references, statements in the speci®cation, patentable, the claimed composition was not known, and whether or declarations under 37 CFR 1.131 or 1.132 . Other forms of it would have been obvious depends upon consideration of the evidence may also be presented during prosecution. Of®ce rebuttal evidence. Appellant did not concede that the only personnel are reminded that evidence that has been presented distinguishing factor of its composition is the statement of in a timely manner should not be ignored, but rather should be intended use and extensively argued that its claimed composition considered on the record. However, not all evidence need be exhibits the unexpected property of neutralizing the lethality of accorded the same weight. In determining the relative weight rattlesnake venom while reducing the occurrence of adverse to accord to rebuttal evidence, considerations such as whether immune reactions in humans. The Federal Circuit found that a nexus exists between the claimed invention and the proffered such a use and unexpected property cannot be ignored ± the evidence, and whether the evidence is commensurate in scope unexpected property is relevant and thus the declarations with the claimed invention, are appropriate. The mere presence describing it should have been considered. of some credible rebuttal evidence does not dictate that an obviousness rejection must always be withdrawn. See MPEP § Nonobviousness can be shown when a person of ordinary skill 2145. Of®ce personnel must consider the appropriate weight to in the art would not have reasonably predicted the claimed be accorded to each piece of evidence. An obviousness rejection invention based on the prior art, and the resulting invention should be made or maintained only if evidence of obviousness would not have been expected. All evidence must be considered outweighs evidence of nonobviousness. See MPEP § 706, when properly presented. subsection I. (ªThe standard to be applied in all cases is the `preponderance of the evidence' test. In other words, an Example 3: examiner should reject a claim if, in view of the prior art and evidence of record, it is more likely than not that the claim is The case of Hearing Components, Inc. v. Shure Inc., 600 F.3d unpatentable.º). MPEP § 716.01(d) provides further guidance 1357, 94 USPQ2d 1385 (Fed. Cir. 2010), involved a disposable on weighing evidence in making a determination of patentability.

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I. ARGUMENT DOES NOT REPLACE EVIDENCE 1281 (Fed. Cir. 1991) (Appellant argued that the WHERE EVIDENCE IS NECESSARY presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis Attorney argument is not evidence unless it is an and therefore rebutted any prima facie showing of admission, in which case, an examiner may use the obviousness, however the closest prior art utilizing admission in making a rejection. See MPEP § 2129 a DEHP plasticized blood collection bag inherently and § 2144.03 for a discussion of admissions as prior achieved same result, although this fact was art. unknown in the prior art.).

The arguments of counsel cannot take the place of ªThe fact that appellant has recognized another evidence in the record. In re Schulze, 346 F.2d 600, advantage which would ¯ow naturally from 602, 145 USPQ 716, 718 (CCPA 1965); In re following the suggestion of the prior art cannot be Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. the basis for patentability when the differences would 1997) (ªAn assertion of what seems to follow from otherwise be obvious.º Ex parte Obiaya, 227 USPQ common experience is just attorney argument and 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art not the kind of factual evidence that is required to taught combustion ¯uid analyzers which used rebut a prima facie case of obviousness.º). See labyrinth heaters to maintain the samples at a MPEP § 716.01(c) for examples of attorney uniform temperature. Although appellant showed statements which are not evidence and which must an unexpectedly shorter response time was obtained be supported by an appropriate af®davit or when a labyrinth heater was employed, the Board declaration. held this advantage would ¯ow naturally from following the suggestion of the prior art.). See also II. ARGUING ADDITIONAL ADVANTAGES OR Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d LATENT PROPERTIES 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished Ð not Prima Facie Obviousness Is Not Rebutted by Merely citable as precedent) (ªThe recitation of an additional Recognizing Additional Advantages or Latent Properties advantage associated with doing what the prior art Present But Not Recognized in the Prior Art suggests does not lend patentability to an otherwise unpatentable invention.º). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 1972) and In re Dillon, 919 F.2d 688, 16 USPQ2d 658 (CCPA 1979) (Claims were directed to grooved 1897 (Fed. Cir. 1990) discussed in MPEP § 2144 carbon disc brakes wherein the grooves were are also pertinent to this issue. provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc See MPEP § 716.02 - § 716.02(g) for a discussion brakes which were grooved for the purpose of of declaratory evidence alleging unexpected results. cooling the faces of the braking members and eliminating dust. The court held the prior art III. ARGUING THAT PRIOR ART DEVICES ARE references when combined would overcome the NOT PHYSICALLY COMBINABLE problems of dust and overheating solved by the prior art and would inherently overcome the steam or ªThe test for obviousness is not whether the features vapor cause of the problem relied upon for of a secondary reference may be bodily incorporated patentability by applicants. Granting a patent on the into the structure of the primary reference.... Rather, discovery of an unknown but inherent function (here the test is what the combined teachings of those venting steam or vapor) ªwould remove from the references would have suggested to those of ordinary public that which is in the public domain by virtue skill in the art.º In re Keller, 642 F.2d 413, 425, 208 of its inclusion in, or obviousness from, the prior USPQ 871, 881 (CCPA 1981). See also In re Sneed, art.º 596 F.2d at 1022, 201 USPQ at 661.); In re 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1983) (ª[I]t is not necessary that the inventions of

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the references be physically combinable to render appellant relied were not stated in the claims; the obvious the invention under review.º); and In speci®cation did not provide evidence indicating re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA these limitations must be read into the claims to give 1973) (ªCombining the teachings of references does meaning to the disputed terms.); Ex not involve an ability to combine their speci®c parte McCullough, 7 USPQ2d 1889, 1891 (Bd. Pat. structures.º). App. & Inter. 1987) (Claimed electrode was rejected as obvious despite assertions that electrode functions However, the claimed combination cannot change differently than would be expected when used in the principle of operation of the primary reference nonaqueous battery since ªalthough the demonstrated or render the reference inoperable for its intended results may be germane to the patentability of a purpose. See MPEP § 2143.01. battery containing appellant's electrode, they are not germane to the patentability of the invention claimed IV. ARGUING AGAINST REFERENCES on appeal.º). INDIVIDUALLY See MPEP § 2111 - § 2116.01, for additional case One cannot show nonobviousness by attacking law relevant to claim interpretation. references individually where the rejections are based on combinations of references. In re Keller, VII. ARGUING ECONOMIC INFEASIBILITY 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ The fact that a combination would not be made by 375 (Fed. Cir. 1986). businessmen for economic reasons does not mean that a person of ordinary skill in the art would not V. ARGUING ABOUT THE NUMBER OF make the combination because of some technological REFERENCES COMBINED incompatibility. In re Farrenkopf, 713 F.2d 714, 219 USPQ 1 (Fed. Cir. 1983) (Prior art reference Reliance on a large number of references in a taught that addition of inhibitors to rejection does not, without more, weigh against the radioimmunoassay is the most convenient, but obviousness of the claimed invention. In re Gorman, costliest solution to stability problem. The court held 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991) that the additional expense associated with the (Court af®rmed a rejection of a detailed claim to a addition of inhibitors would not discourage one of candy sucker shaped like a thumb on a stick based ordinary skill in the art from seeking the convenience on thirteen prior art references.). expected therefrom.).

VI. ARGUING LIMITATIONS WHICH ARE NOT VIII. ARGUING ABOUT THE AGE OF CLAIMED REFERENCES

Although the claims are interpreted in light of the ªThe mere age of the references is not persuasive of speci®cation, limitations from the speci®cation are the unobviousness of the combination of their not read into the claims. In re Van Geuns, 988 F.2d teachings, absent evidence that, notwithstanding 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to knowledge of the references, the art tried and failed a superconducting magnet which generates a to solve the problem.º In re Wright, 569 F.2d 1124, ªuniform magnetic ®eldº were not limited to the 1127, 193 USPQ 332, 335 (CCPA 1977) (100 year degree of magnetic ®eld uniformity required for old patent was properly relied upon in a rejection Nuclear Magnetic Resonance (NMR) imaging. based on a combination of references.). See also Ex Although the speci®cation disclosed that the claimed parte Meyer, 6 USPQ2d 1966 (Bd. Pat. App. & Inter. magnet may be used in an NMR apparatus, the 1988) (length of time between the issuance of prior claims were not so limited.); Constant v. Advanced art patents relied upon (1920 and 1976) was not Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 persuasive of unobviousness). USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which

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IX. ARGUING THAT PRIOR ART IS combination was obvious to try might show that it NONANALOGOUS was obvious under § 103.º KSR Int©l Co. v. Tele¯ex Inc., 550 U.S. 538, 421, 82 USPQ2d 1385, 1397 See MPEP § 2141.01(a) for case law pertaining to (2007). analogous art. ªThe admonition that `obvious to try' is not the X. ARGUING IMPROPER RATIONALES FOR standard under § 103 has been directed mainly at COMBINING REFERENCES two kinds of error. In some cases, what would have been `obvious to try' would have been to vary all A. Impermissible Hindsight parameters or try each of numerous possible choices until one possibly arrived at a successful result, Applicants may argue that the examiner's conclusion where the prior art gave either no indication of which of obviousness is based on improper hindsight parameters were critical or no direction as to which reasoning. However, ª[a]ny judgment on of many possible choices is likely to be successful.... obviousness is in a sense necessarily a reconstruction In others, what was `obvious to try' was to explore based on hindsight reasoning, but so long as it takes a new technology or general approach that seemed into account only knowledge which was within the to be a promising ®eld of experimentation, where level of ordinary skill in the art at the time the the prior art gave only general guidance as to the claimed invention was made and does not include particular form of the claimed invention or how to knowledge gleaned only from applicant's disclosure, achieve it.º In re O'Farrell, 853 F.2d 894, 903, 7 such a reconstruction is proper.º In re McLaughlin, USPQ2d 1673, 1681 (Fed. Cir. 1988) (citations 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA omitted) (The court held the claimed method would 1971). Applicants may also argue that the have been obvious over the prior art relied upon combination of two or more references is ªhindsightº because one reference contained a detailed enabling because ªexpressº motivation to combine the methodology, a suggestion to modify the prior art references is lacking. However, there is no to produce the claimed invention, and evidence requirement that an ªexpress, written motivation to suggesting the modi®cation would be successful.). combine must appear in prior art references before a ®nding of obviousness.º See Ruiz v. A.B. Chance C. Lack of Suggestion To Combine References Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP § 2141 and § 2143 for A suggestion or motivation to combine references guidance regarding establishment of a prima facie is an appropriate method for determining case of obviousness. obviousness, however it is just one of a number of valid rationales for doing so. The Court in KSR B. Obvious To Try Rationale identi®ed several exemplary rationales to support a conclusion of obviousness which are consistent with An applicant may argue the examiner is applying an the proper ªfunctional approachº to the improper ªobvious to tryº rationale in support of an determination of obviousness as laid down in obviousness rejection. Graham. KSR, 550 U.S. at 415-21, 82 USPQ2d at 1395-97. See MPEP § 2141 and § 2143. An ªobvious to tryº rationale may support a conclusion that a claim would have been obvious D. References Teach Away from the Invention or where one skilled in the art is choosing from a ®nite Render Prior Art Unsatisfactory for Intended Purpose number of identi®ed, predictable solutions, with a reasonable expectation of success. ª [A] person of In addition to the material below, see MPEP ordinary skill has good reason to pursue the known § 2141.02 (prior art must be considered in its options within his or her technical grasp. If this leads entirety, including disclosures that teach away from to the anticipated success, it is likely that product the claims) and MPEP § 2143.01 (proposed [was] not of innovation but of ordinary skill and modi®cation cannot render the prior art common sense. In that instance the fact that a

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unsatisfactory for its intended purpose or change the 3. Proceeding Contrary to Accepted Wisdom Is principle of operation of a reference). Evidence of Nonobviousness

1. The Nature of the Teaching Is Highly Relevant The totality of the prior art must be considered, and proceeding contrary to accepted wisdom in the art A prior art reference that ªteaches awayº from the is evidence of nonobviousness. In re Hedges, 783 claimed invention is a signi®cant factor to be F.2d 1038, 228 USPQ 685 (Fed. Cir. 1986) considered in determining obviousness; however, (Applicant's claimed process for sulfonating ªthe nature of the teaching is highly relevant and diphenyl sulfone at a temperature above 127ëC was must be weighed in substance. A known or obvious contrary to accepted wisdom because the prior art composition does not become patentable simply as a whole suggested using lower temperatures for because it has been described as somewhat inferior optimum results as evidenced by charring, to some other product for the same use.º In decomposition, or reduced yields at higher re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 temperatures.). (Fed. Cir. 1994) (Claims were directed to an epoxy resin based printed circuit material. A prior art Furthermore, ª[k]nown disadvantages in old devices reference disclosed a polyester-imide resin based which would naturally discourage search for new printed circuit material, and taught that although inventions may be taken into account in determining epoxy resin based materials have acceptable stability obviousness.º United States v. Adams, 383 U.S. 39, and some degree of ¯exibility, they are inferior to 52, 148 USPQ 479, 484 (1966). polyester-imide resin based materials. The court held the claims would have been obvious over the prior E. Applicability of KSR to All Technologies art because the reference taught epoxy resin based material was useful for applicant's purpose, applicant At the time the KSR decision was handed down, did not distinguish the claimed epoxy from the prior some observers questioned whether the principles art epoxy, and applicant asserted no discovery discussed were intended by the Supreme Court to beyond what was known to the art.). apply to all ®elds of inventive endeavor. Arguments were made that because the technology at issue in Furthermore, ªthe prior art's mere disclosure of more KSR involved the relatively well-developed and than one alternative does not constitute a teaching predictable ®eld of vehicle pedal assemblies, the away from any of these alternatives because such decision was relevant only to such ®elds. The disclosure does not criticize, discredit, or otherwise Federal Circuit has soundly repudiated such a notion, discourage the solution claimed¼.º In re Fulton, stating that KSR applies across technologies: 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). This court also declines to cabin KSR to the ªpredictable artsº (as opposed to the 2. References Cannot Be Combined Where Reference ªunpredictable artº of biotechnology). In fact, Teaches Away from Their Combination this record shows that one of skill in this advanced art would ®nd these claimed ªresultsº It is improper to combine references where the profoundly ªpredictable.º references teach away from their combination. In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769, 779 In re Kubin, 561 F.3d 1351, 1360, 90 USPQ2d 1417, (Fed. Cir. 1983) (The claimed catalyst which 1424 (Fed. Cir. 2009). Thus, Of®ce personnel should contained both iron and an alkali metal was not not withdraw any rejection solely on the basis that suggested by the combination of a reference which the invention lies in a technological area ordinarily taught the interchangeability of antimony and alkali considered to be unpredictable. metal with the same bene®cial result, combined with a reference expressly excluding antimony from, and adding iron to, a catalyst.).

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XI. FORM PARAGRAPHS art against the claimed invention if that subject matter and the claimed invention ªwere, at the time See MPEP § 707.07(f) for form paragraphs 7.37 the invention was made, owned by the same person through 7.38 which may be used where applicant's or subject to an obligation of assignment to the same arguments are not persuasive or are moot. person.º This amendment to pre-AIA 35 U.S.C. 103(c) was made pursuant to section 4807 of the 2146 Pre-AIA 35 U.S.C. 103(c) [R-11.2013] American Inventors Protection Act of 1999 (AIPA); see Pub. L. 106-113, 113 Stat. 1501, 1501A-591 [Editor Note: This MPEP section has limited (1999). The changes to pre-AIA 35 U.S.C. 102(e) applicability to applications subject to examination in the Intellectual Property and High Technology under the ®rst inventor to ®le (FITF) provisions of Technical Amendments Act of 2002 (Pub. L. the AIA as set forth in 35 U.S.C. 100 (note). See 107-273, 116 Stat. 1758 (2002)) did not affect the MPEP § 2159 et seq. to determine whether an exclusion under pre-AIA 35 U.S.C. 103(c) as application is subject to examination under the FITF amended on November 29, 1999. Subsequently, the provisions, MPEP § 2156 for joint research Cooperative Research and Technology Enhancement agreement prior art disquali®cation for application Act of 2004 (CREATE Act) (Pub. L. 108-453, 118 subject to those provisions, and MPEP § 2150 et Stat. 3596 (2004)) further amended pre-AIA 35 seq. for examination of applications subject to those U.S.C. 103(c) to provide that subject matter provisions.] developed by another person shall be treated as owned by the same person or subject to an obligation Pre-AIA 35 U.S.C. 103 Conditions of patentability; of assignment to the same person for purposes of non-obvious subject matter. determining obviousness if three conditions are met: ***** (A) the claimed invention was made by or on (c)(1) Subject matter developed by another person, behalf of parties to a joint research agreement that which quali®es as prior art only under one or more of was in effect on or before the date the claimed subsections (e), (f), and (g) of section 102, shall not preclude invention was made; patentability under this section where the subject matter and the claimed invention were, at the time the claimed invention was (B) the claimed invention was made as a result made, owned by the same person or subject to an obligation of of activities undertaken within the scope of the joint assignment to the same person. research agreement; and (2) For purposes of this subsection, subject matter (C) the application for patent for the claimed developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to invention discloses or is amended to disclose the an obligation of assignment to the same person if Ð names of the parties to the joint research agreement (hereinafter ªjoint research agreement (A) the claimed invention was made by or on disquali®cationº). behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; These changes to pre-AIA 35 U.S.C. 103(c) apply (B) the claimed invention was made as a result of to all patents (including reissue patents) granted on activities undertaken within the scope of the joint research or after December 10, 2004 that are subject to agreement; and pre-AIA 35 U.S.C. 102. The amendment to pre-AIA (C) the application for patent for the claimed 35 U.S.C. 103(c) made by the AIPA to change invention discloses or is amended to disclose the names of the ªsubsection (f) or (g)º to ªone of more of subsections parties to the joint research agreement. (e), (f), or (g)º applies to applications ®led on or (3) For purposes of paragraph (2), the term ªjoint after November 29, 1999. It is to be noted that, for research agreementº means a written contract, grant, or cooperative agreement entered into by two or more persons or all applications (including reissue applications), if entities for the performance of experimental, developmental, or the application is pending on or after December 10, research work in the ®eld of the claimed invention. 2004, the 2004 changes to pre-AIA 35 U.S.C. 103(c), which effectively include the 1999 changes, apply; Effective November 29, 1999, subject matter which thus, the November 29, 1999 date of the prior was prior art under former 35 U.S.C. 103 via revision to pre-AIA 35 U.S.C. 103(c) is no longer pre-AIA 35 U.S.C. 102(e) was disquali®ed as prior

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relevant. In a reexamination proceeding, however, Leahy-Smith America Invents Act one must look at whether or not the patent being [R-11.2013] reexamined was granted on or after December 10, 2004 to determine whether pre-AIA 35 U.S.C. [Editor Note: See MPEP § 2159 et seq. to determine 103(c), as amended by the CREATE Act, applies. whether an application is subject to examination For a reexamination proceeding of a patent granted under the FITF provisions, and MPEP § prior to December 10, 2004 on an application ®led 2131-MPEP § 2138 for examination of applications on or after November 29, 1999, it is the 1999 subject to pre-AIA 35 U.S.C. 102.] changes to pre-AIA 35 U.S.C. 103(c) that are applicable to the disqualifying commonly Continued Applicability of pre-AIA 35 U.S.C. 102 assigned/owned prior art provisions of pre-AIA 35 and 103: The Leahy-Smith America Invents Act U.S.C. 103(c). See MPEP § 706.02(l)(1) for (AIA) revised 35 U.S.C. 102 and thereby, the additional information regarding disquali®ed prior standard to determine what prior art is available art under pre-AIA 35 U.S.C. 102(e)/103. For a during examination of an application. See Pub. L. reexamination proceeding of a patent granted prior 112-29, 125 Stat. 284 (2011). The changes to 35 to December 10, 2004 on an application ®led prior U.S.C. 102 and 103 in the AIA do not apply to any to November 29, 1999, neither the 1999 nor the 2004 application ®led before March 16, 2013. Thus, any changes to pre-AIA 35 U.S.C. 103(c) are applicable. application ®led before March 16, 2013, is governed Therefore, only prior art under pre-AIA 35 U.S.C. by pre-AIA 35 U.S.C. 102 and 103 (i.e., the 102(f) or (g) used in a rejection under pre-AIA 35 application is a pre-AIA (®rst to invent) application U.S.C. 103(a) may be disquali®ed under the (hereinafter ªpre-AIA applicationº)). Note that commonly assigned/owned prior art provision neither the ®ling of a request for continued pre-AIA of 35 U.S.C. 103(c). examination, nor entry into the national stage under 35 U.S.C. 371, constitutes the ®ling of a new Pre-AIA 35 U.S.C. 103(c), as amended by the application. Accordingly, even if a request for CREATE Act, applies only to subject matter which continued examination under 37 CFR 1.114 is ®led quali®es as prior art under pre-AIA 35 U.S.C. on or after March 16, 2013, in an application that 102(e), (f), or (g), and which is being relied upon in was ®led before March 16, 2013, the application a rejection under 35 U.S.C. 103. If the rejection is remains subject to pre-AIA 35 U.S.C. 102 and 103. anticipation under pre-AIA 35 U.S.C. 102(e), (f), or Submission of an amendment including a claim that (g), pre-AIA 35 U.S.C. 103(c) cannot be relied upon includes new matter on or after March 16, 2013, also to disqualify the subject matter in order to overcome does not affect an application's status as a pre-AIA or prevent the anticipation rejection. Likewise, application. See 35 U.S.C. 132(a). Similarly, a PCT pre-AIA 35 U.S.C. 103(c) cannot be relied upon to application ®led under 35 U.S.C. 363 before March overcome or prevent a double patenting rejection. 16, 2013, is subject to pre-AIA 35 U.S.C. 102 and See 37 CFR 1.78(c) and MPEP § 804. See also 103, regardless of whether the application enters the MPEP § 706.02(l) - § 706.02(l)(3). national stage under 35 U.S.C. 371 before or after March 16, 2013. Applications ®led on or after March 2147 16, 2013 are also subject to pre-AIA 35 U.S.C. 102 -2149 [Reserved] if the application has never contained a claim with an effective ®ling date on or after March 16, 2013 and has never claimed the bene®t of an application 2150 Examination Guidelines for 35 U.S.C. that ever contained such a claim. MPEP §§ 102 and 103 as Amended by the First 2131-2138 provide examination guidance on the Inventor To File Provisions of the

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prior art available in the examination of applications application or reissued patent) in 35 U.S.C. 100(i)(1) subject to pre-AIA 35 U.S.C. 102. as meaning the earlier of: (1) The actual ®ling date of the patent or the application for the patent 2151 Overview of the Changes to 35 U.S.C. containing the claimed invention; or (2) the ®ling 102 and 103 in the AIA [R-11.2013] date of the earliest provisional, nonprovisional, international (PCT), or foreign patent application to [Editor Note: This MPEP section is only applicable which the patent or application is entitled to bene®t to applications subject to examination under the ®rst or priority as to such claimed invention. The AIA inventor to ®le (FITF) provisions of the AIA as set de®nes the term ªinventorº in 35 U.S.C. 100(f) as forth in 35 U.S.C. 100 (note). See MPEP § 2159 et the individual or, if a joint invention, the individuals seq. to determine whether an application is subject collectively who invented or discovered the subject to examination under the FITF provisions, and matter of the invention, and in 35 U.S.C. 100(g) MPEP § 2131-MPEP § 2138 for examination of de®nes the term ªjoint inventorº and ªcoinventorº applications subject to pre-AIA 35 U.S.C. 102.] to mean any one of the individuals who invented or discovered the subject matter of a joint invention. After the AIA, 35 U.S.C. 102 continues to set forth the scope of prior art that will preclude the grant of As discussed previously, AIA 35 U.S.C. 102(a)(1) a patent on a claimed invention, but revises what provides that a person is not entitled to a patent if quali®es as prior art. Speci®cally, AIA 35 U.S.C. the claimed invention was patented, described in a 102(a)(1) and (a)(2) set forth what quali®es as prior printed publication, or in public use, on sale, or art. AIA 35 U.S.C. 102(a)(1) provides that a person otherwise available to the public before the effective is not entitled to a patent if the claimed invention ®ling date of the claimed invention. Under pre-AIA was patented, described in a printed publication, or 35 U.S.C. 102(a) and (b), knowledge or use of the in public use, on sale, or otherwise available to the invention (pre-AIA 35 U.S.C. 102(a)), or public use public before the effective ®ling date of the claimed or sale of the invention (pre-AIA 35 U.S.C. 102(b)), invention. AIA 35 U.S.C. 102(a)(2) provides that a was required to be in the United States to qualify as person is not entitled to a patent if the claimed a prior art activity. Under the AIA, a prior public invention was described in a patent issued under 35 use, sale activity, or other disclosure has no U.S.C. 151, or in an application for patent published geographic requirement (i.e., need not be in the or deemed published under 35 U.S.C. 122(b), in United States) to qualify as prior art. which the patent or application, as the case may be, names another inventor, and was effectively ®led AIA 35 U.S.C. 102(b)(1) provides that certain before the effective ®ling date of the claimed disclosures made one year or less before the effective invention. AIA 35 U.S.C. 102(b) sets forth ®ling date of a claimed invention shall not be prior exceptions to prior art established in AIA 35 U.S.C. art under 35 U.S.C. 102(a)(1) with respect to the 102(a). Speci®cally, AIA 35 U.S.C. 102(b)(1) sets claimed invention if: (1) The disclosure was made forth exceptions to prior art established in AIA 35 by the inventor or joint inventor or by another who U.S.C. 102(a)(1), and AIA 35 U.S.C. 102(b)(2) sets obtained the subject matter disclosed directly or forth exceptions to prior art established in AIA 35 indirectly from the inventor or a joint inventor; or U.S.C. 102(a)(2). (2) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor The AIA also provides de®nitions in 35 U.S.C. 100 or a joint inventor or by another who obtained the of the meaning of the terms ªclaimed invention,º subject matter disclosed directly or indirectly from ªeffective ®ling date,º ªinventor,º and ªjoint the inventor or a joint inventor. Thus, AIA 35 U.S.C. inventorº (or ªcoinventorº). The AIA de®nes the 102(b)(1) effectively provides a one-year grace term ªclaimed inventionº in 35 U.S.C. 100(j) as the period (grace period) after a ®rst inventor-originated subject matter de®ned by a claim in a patent or an disclosure of an invention within which the inventor, application for a patent. The AIA de®nes the term assignee, obligated assignee, or other party having ªeffective ®ling dateº for a claimed invention in a suf®cient interest may ®le a patent application which patent or application for patent (other than a reissue is not subject to such disclosure and certain other

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disclosures as prior art. The one-year grace period the United States is treated as a U.S. patent in AIA 35 U.S.C. 102(b)(1) is measured from the application publication only if the PCT application ®ling date of the earliest U.S. or foreign patent was ®led on or after November 29, 2000, and application to which a proper bene®t or priority published under PCT Article 21(2) in the English claim to such invention has been asserted in the language. See MPEP § 2136.03, subsection III. patent or application and the earlier application supports the claimed invention in the manner AIA 35 U.S.C. 102(d) de®nes ªeffectively ®ledº for required by 35 U.S.C. 112(a). Under pre-AIA 35 the purpose of determining whether a particular U.S. U.S.C. 102(b), the one-year grace period is measured patent document is prior art under AIA 35 U.S.C. from the ®ling date of the earliest application ®led 102(a)(2) to a claimed invention. A U.S. patent in the United States (directly or through the PCT) document is considered to have been effectively ®led and not from the dates of earlier ®led foreign patent for purposes of its prior art effect under 35 U.S.C. applications. 102(a)(2) with respect to any subject matter it describes on the earlier of: (1) The actual ®ling date The date of invention is not relevant under AIA 35 of the patent or the application for patent; or (2) if U.S.C. 102. Thus, a prior art disclosure could not be the patent or application for patent is entitled to claim disquali®ed or antedated by showing that the the bene®t of, or priority to, the ®ling date of an inventor invented the claimed invention prior to the earlier U.S. provisional, U.S. nonprovisional, effective date of the prior art disclosure of the subject international (PCT), or foreign patent application, matter (e.g., under the provisions of 37 CFR 1.131). the ®ling date of the earliest such application that describes the subject matter of the claimed invention. As discussed previously, AIA 35 U.S.C. 102(a)(2) Thus, a U.S. patent document is effective as prior provides that a person is not entitled to a patent if art as of the ®ling date of the earliest application to the claimed invention was described in a U.S. patent, which bene®t or priority is claimed and which a U.S. patent application publication, or an describes the subject matter relied upon, regardless application for patent deemed published under 35 of whether the earliest such application is a U.S. U.S.C. 122(b) (collectively referred to as ªU.S. provisional or nonprovisional application, an patent documentsº), that names another inventor and international (PCT) application, or a foreign patent was effectively ®led before the effective ®ling date application. of the claimed invention. Under 35 U.S.C. 374, a World Intellectual Property Organization (WIPO) AIA 35 U.S.C. 102(b)(2)(A) and (B) provide that a publication of a Patent Cooperation Treaty (PCT) disclosure shall not be prior art to a claimed international application that designates the United invention under 35 U.S.C. 102(a)(2) if: (1) The States is an application for patent deemed published subject matter disclosed was obtained directly or under 35 U.S.C. 122(b) for purposes of AIA 35 indirectly from the inventor or a joint inventor; or U.S.C. 102(a)(2). Thus, under the AIA, WIPO (2) the subject matter disclosed had, before such publications of PCT applications that designate the subject matter was effectively ®led under 35 U.S.C. United States are treated as U.S. patent application 102(a)(2), been publicly disclosed by the inventor publications for prior art purposes, regardless of the or a joint inventor or another who obtained the international ®ling date, whether they are published subject matter disclosed directly or indirectly from in English, or whether the PCT international the inventor or a joint inventor. Thus, under the AIA, application enters the national stage in the United a U.S. patent document that was not issued or States. Accordingly, a WIPO publication of a PCT published more than one year before the effective application (WIPO published application) that ®ling date of the claimed invention is not prior art designates the United States, a U.S. patent, or a U.S. to the claimed invention if: (1) The U.S. patent patent application publication that names another document was by another who obtained the subject inventor and was effectively ®led before the effective matter disclosed from the inventor or a joint ®ling date of the claimed invention, is prior art under inventor; or (2) the inventor or a joint inventor, or AIA 35 U.S.C. 102(a)(2). Under pre-AIA 35 U.S.C. another who obtained the subject matter disclosed 102(e), a WIPO published application designating from an inventor or joint inventor, had publicly

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disclosed the subject matter before the 35 U.S.C. is likewise not relevant to patentability under the 102(d) (ªeffectively ®ledº) date of the U.S. patent AIA unless there is a prior disclosure or ®ling of an document. application by another. A situation in which an application names a person who is not the actual Additionally, AIA 35 U.S.C. 102(b)(2)(C) provides inventor as the inventor (pre-AIA 35 U.S.C. 102(f)) that a disclosure made in a U.S. patent document will be handled in a derivation proceeding under 35 shall not be prior art to a claimed invention under U.S.C. 135, by a correction of inventorship under 35 U.S.C. 102(a)(2) if, not later than the effective 37 CFR 1.48 to name the actual inventor, or through ®ling date of the claimed invention, the subject a rejection under 35 U.S.C. 101 and 35 U.S.C. 115. matter disclosed and the claimed invention were See form paragraphs 7.04.101.aia and 7.04.102.aia. owned by the same person or subject to an obligation of assignment to the same person. This provision AIA 35 U.S.C. 102(c) provides for common replaces the exception in pre-AIA 35 U.S.C. 103(c) ownership of subject matter made pursuant to joint that applied only in the context of an obviousness research agreements. Under 35 U.S.C. 100(h), the analysis under 35 U.S.C. 103 to prior art that was term ªjoint research agreementº as used in AIA 35 commonly owned at the time the claimed invention U.S.C. 102(c) is de®ned as a written contract, grant, was made, and which quali®ed as prior art only or cooperative agreement entered into by two or under pre-AIA 35 U.S.C. 102(e), (f), and/or (g). more persons or entities for the performance of Thus, the AIA provides that certain prior patents and experimental, developmental, or research work in published patent applications of co-workers and the ®eld of the claimed invention. AIA 35 U.S.C. collaborators are not prior art either for purposes of 102(c) speci®cally provides that subject matter determining novelty (35 U.S.C. 102) or disclosed and a claimed invention shall be deemed nonobviousness (35 U.S.C. 103). This exception, to have been owned by the same person or subject however, only removes disclosures as prior art under to an obligation of assignment to the same person AIA 35 U.S.C. 102(a)(2), namely, U.S. patent in applying the provisions of AIA 35 U.S.C. documents that were not published, but that were 102(b)(2)(C) if: (1) The subject matter disclosed was effectively ®led, before the effective ®ling date of developed and the claimed invention was made by, the claimed invention. This exception is not effective or on behalf of, one or more parties to a joint to except prior art that is also available under 35 research agreement that was in effect on or before U.S.C. 102(a)(1), that is, patents, printed the effective ®ling date of the claimed invention; (2) publications, public uses, sale activities, or other the claimed invention was made as a result of publicly available disclosures published or occurring activities undertaken within the scope of the joint before the effective ®ling date of the claimed research agreement; and (3) the application for patent invention. A prior disclosure, as de®ned in AIA 35 for the claimed invention discloses or is amended to U.S.C. 102(a)(1), by a co-worker or collaborator is disclose the names of the parties to the joint research prior art under AIA 35 U.S.C. 102(a)(1) unless it agreement. falls within an exception under AIA 35 U.S.C. 102(b)(1), regardless of whether the subject matter AIA 35 U.S.C. 103 provides that a patent for a of the prior disclosure and the claimed invention was claimed invention may not be obtained, commonly owned not later than the effective ®ling notwithstanding that the claimed invention is not date of the claimed invention. identically disclosed as set forth in 35 U.S.C. 102, if the differences between the claimed invention and The AIA eliminates the provisions in pre-AIA 35 the prior art are such that the claimed invention as U.S.C. 102(c) (abandonment of the invention), a whole would have been obvious before the 102(d) (premature foreign patenting), 102(f) effective ®ling date of the claimed invention to a (derivation), and 102(g) (prior invention by another, person having ordinary skill in the art to which the but see below for discussion of continued limited claimed invention pertains. In addition, AIA 35 applicability). Under the AIA, abandonment of the U.S.C. 103 provides that patentability shall not be invention or premature foreign patenting is not negated by the manner in which the invention was relevant to patentability. Prior invention by another made. This provision tracks pre-AIA 35 U.S.C.

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103(a), except that the temporal focus for the 120, 121, or 365(c) based upon an earlier application obviousness inquiry is before the effective ®ling that ever contained a claimed invention having an date of the claimed invention, rather than at the time effective ®ling date as de®ned in 35 U.S.C. 100(i) of the invention. The provisions of pre-AIA 35 that is before March 16, 2013, and (2) also contains U.S.C. 103(c) have been replaced with AIA 35 or contained at any time any claimed invention U.S.C. 102(b)(2)(C) and (c), and the provisions of having an effective ®ling date as de®ned in 35 pre-AIA 35 U.S.C. 103(b) pertaining to U.S.C. 100(i) that is on or after March 16, 2013, or biotechnological processes have been eliminated. ever claimed the bene®t of an earlier ®ling date under 35 U.S.C. 120, 121, or 365 based upon an AIA 35 U.S.C. 102 and 103 took effect on March earlier application that ever contained a claimed 16, 2013. These new provisions apply to any patent invention having an effective ®ling date as de®ned application that contains or contained at any time: in 35 U.S.C. 100(i) that is on or after March 16, (1) a claim to a claimed invention that has an 2013, then AIA 35 U.S.C. 102 and 103 apply to the effective ®ling date as de®ned in 35 U.S.C. 100(i) application, and each claimed invention in the that is on or after March 16, 2013; or (2) a application is also subject to pre-AIA 35 U.S.C. designation as a continuation, divisional, or 102(g). continuation-in-part of an application that contains or contained at any time a claim to a claimed 2152 Detailed Discussion of AIA 35 U.S.C. invention that has an effective ®ling date that is on 102(a) and (b) [R-11.2013] or after March 16, 2013. Such an application is referred to as an AIA (®rst inventor to ®le) [Editor Note: This MPEP section is only applicable application (hereinafter ªAIA applicationº). AIA 35 to applications subject to examination under the ®rst U.S.C. 102 and 103 also apply to any patent resulting inventor to ®le (FITF) provisions of the AIA as set from an AIA application. See Pub. L. 112-29, § forth in 35 U.S.C. 100 (note). See MPEP § 2159 et 3(n)(1), 125 Stat. at 293. See also MPEP § 2159 et seq. to determine whether an application is subject seq. for guidance in determining whether an to examination under the FITF provisions, and application is subject to AIA 35 U.S.C. 102 and 103. MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] The AIA provides that the provisions of pre-AIA 35 U.S.C. 102(g) apply to each claim of an AIA AIA 35 U.S.C. 102(a) de®nes the prior art that will application for patent if the patent application: (1) preclude the grant of a patent on a claimed invention contains or contained at any time a claim to a unless an exception in AIA 35 U.S.C. 102(b) is claimed invention having an effective ®ling date as applicable. Speci®cally, AIA 35 U.S.C. 102(a) de®ned in 35 U.S.C. 100(i) that occurs before March provides that: 16, 2013; or (2) is ever designated as a continuation, divisional, or continuation-in-part of an application [a] person shall be entitled to a patent unlessÐ that contains or contained at any time a claim to a claimed invention that has an effective ®ling date (1) the claimed invention was patented, before March 16, 2013. Pub. L. 112-29, § 3(n)(2), described in a printed publication, or in public 125 Stat. at 293. Pre-AIA 35 U.S.C. 102(g) also use, on sale, or otherwise available to the public applies to any patent resulting from an AIA before the effective ®ling date of the claimed application to which pre-AIA 35 U.S.C. 102(g) invention; or applied. See MPEP § 2138 for guidance on (2) the claimed invention was described in application of pre-AIA 35 U.S.C. 102(g) and form a patent issued under section 151, or in an paragraph 7.14.aia. application for patent published or deemed published under section 122(b), in which the If an application (1) contains or contained at any patent or application, as the case may be, names time a claimed invention having an effective ®ling another inventor and was effectively ®led date that is before March 16, 2013, or ever claimed before the effective ®ling date of the claimed the bene®t of an earlier ®ling date under 35 U.S.C. invention.

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As an initial matter, Of®ce personnel should note not be prior art if it falls within an exception under that the introductory phrase ª[a] person shall be AIA 35 U.S.C. 102(b). entitled to a patent unlessº remains unchanged from the pre-AIA version of 35 U.S.C. 102. Thus, 35 Exceptions to the categories of prior art de®ned in U.S.C. 102 continues to provide that the Of®ce bears AIA 35 U.S.C. 102(a)(1) are provided in AIA 35 the initial burden of explaining why the applicable U.S.C. 102(b)(1). Speci®cally, AIA 35 U.S.C. statutory or regulatory requirements have not been 102(b)(1) states that ª[a] disclosure made 1 year or met if a claim in an application is to be rejected. The less before the effective ®ling date of a claimed AIA also does not change the requirement that invention shall not be prior art to the claimed whenever a claim for a patent is rejected or an invention under subsection (a)(1) ifÐ objection or requirement is made, the Of®ce shall notify the applicant thereof and state the reasons for (A) the disclosure was made by the inventor or such rejection, objection, or requirement, and provide a joint inventor or by another who obtained the such information and references as may be useful to subject matter disclosed directly or indirectly from the applicant in judging of the propriety of the inventor or a joint inventor; or continuing the prosecution of the application. See (B) the subject matter disclosed had, before such 35 U.S.C. 132, 37 CFR 1.104(c) and MPEP § 706. disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the The categories of prior art documents and activities subject matter disclosed directly or indirectly from are set forth in AIA 35 U.S.C. 102(a)(1) and the the inventor or a joint inventor.º categories of prior art patent documents are set forth in AIA 35 U.S.C. 102(a)(2). These documents and Exceptions to the categories of prior art de®ned in activities are used to determine whether a claimed AIA 35 U.S.C. 102(a)(2) are provided in AIA 35 invention is novel or nonobvious. The documents U.S.C. 102(b)(2). Speci®cally, AIA 35 U.S.C. upon which a prior art rejection under 35 U.S.C. 102(b)(2) states that ª[a] disclosure shall not be prior 102(a)(1) may be based are an issued patent, a art to a claimed invention under subsection (a)(2) published application, and a non-patent printed ifÐ publication. The documents upon which a prior art rejection under 35 U.S.C. 102(a)(2) may be based (A) the subject matter disclosed was obtained are U.S. patent documents only (see discussion of directly or indirectly from the inventor or a joint U.S. patent documents in MPEP § 2151). Evidence inventor; that the claimed invention was in public use, on sale, (B) the subject matter disclosed had, before such or otherwise available to the public may also be used subject matter was effectively ®led under subsection as the basis for a prior art rejection under 35 U.S.C. (a)(2), been publicly disclosed by the inventor or a 102(a)(1). Note that a printed publication that does joint inventor or another who obtained the subject not have a suf®ciently early publication date to itself matter disclosed directly or indirectly from the qualify as prior art under AIA 35 U.S.C. 102(a)(1) inventor or a joint inventor; or may be competent evidence of a previous public use, (C) the subject matter disclosed and the claimed sale activity, or other availability of a claimed invention, not later than the effective ®ling date of invention to the public where the public use, sale the claimed invention, were owned by the same activity, or other public availability does have a person or subject to an obligation of assignment to suf®ciently early date to qualify as prior art under the same person.º AIA 35 U.S.C. 102(a)(1). See In re Epstein, 32 F.3d 1559, 31 USPQ2d 1817 (Fed. Cir. 1994) and MPEP Although some of the provisions of AIA 35 U.S.C. § 2133.03(b), subsection III.C. 102(a) and (b) are similar to pre-AIA 35 U.S.C. 102(a), (b), and (e), the AIA has introduced a number AIA 35 U.S.C. 102(b) sets out exceptions to AIA of important changes with respect to prior art 35 U.S.C. 102(a), in that prior art that otherwise documents and activities (collectively, would be included in AIA 35 U.S.C. 102(a) shall ªdisclosuresº). First, the availability of a U.S. patent document as prior art to a claimed invention is

Rev. 07.2015, October 2015 2100-202 PATENTABILITY § 2152.02

measured from the effective ®ling date of the under 35 U.S.C. 119, 120, 121, or 365. See 35 U.S.C. claimed invention as de®ned in 35 U.S.C. 100(i), 100(i)(1). Thus, the one-year grace period (as de®ned which takes into account both foreign priority and in MPEP § 2151) in AIA 35 U.S.C. 102(b)(1) is domestic bene®t dates. Note that this differs from measured from the ®ling date of any U.S. or foreign practice under pre-AIA 35 U.S.C. 102 wherein the patent application to which the patent or application availability of a patent document as prior art is is entitled to bene®t or priority as to such invention, measured from either ªthe date of the application whereas the one-year grace period in pre-AIA 35 for patent in the United Statesº (pre-AIA 35 U.S.C. U.S.C. 102(b) is measured from only the ®ling date 102(b)) or ªthe invention thereof by the applicant of the earliest application ®led in the United States for patentº (pre-AIA 35 U.S.C. 102(a) and (e)). (directly or through the PCT). Second, the AIA adopts a global view of prior art disclosures and thus does not require that a public As under pre-AIA law, the effective ®ling date of a use or sale activity be ªin this countryº to be a prior claimed invention is determined on a claim-by-claim art activity. Finally, a catch-all ªotherwise available basis and not an application-by-application basis. to the publicº category of prior art is added. That is, the principle that different claims in the same application may be entitled to different effective 2152.01 Effective Filing Date of the Claimed ®ling dates vis-à-vis the prior art remains unchanged Invention [R-11.2013] by the AIA. See MPEP § 706.02, subsection VI. However, it is important to note that although prior [Editor Note: This MPEP section is only applicable art is applied on a claim-by-claim basis, the to applications subject to examination under the ®rst determination of whether pre-AIA 35 U.S.C. 102 inventor to ®le (FITF) provisions of the AIA as set and 35 U.S.C. 103 or AIA 35 U.S.C. 102 and 103 forth in 35 U.S.C. 100 (note). See MPEP § 2159 et apply is made on an application-by-application basis. seq. to determine whether an application is subject MPEP § 2151 and MPEP § 2159 discuss the to examination under the FITF provisions, and applicability date provisions of section 3 of the AIA. MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] Finally, the AIA provides that the ªeffective ®ling dateº for a claimed invention in a reissued patent or Pre-AIA 35 U.S.C. 102(a) and (e) reference application for a reissue patent shall be determined patent-defeating activities occurring before the by deeming the claim to the claimed invention to applicant invented the claimed invention. AIA 35 have been contained in the patent for which reissue U.S.C. 102(a)(1) and (a)(2) make no mention of the was sought. See 35 U.S.C. 100(i)(2). date of the invention, but instead concern documents that existed or activities that occurred ªbefore the 2152.02 Prior Art Under AIA 35 U.S.C. effective ®ling date of the claimed invention.º As a 102(a)(1) (Patented, Described in a Printed result, it is no longer possible to antedate or ªswear Publication, or in Public Use, on Sale, or behindº certain prior art disclosures by making a Otherwise Available to the Public) showing under 37 CFR 1.131 that the applicant [R-11.2013] invented the claimed subject matter prior to the effective date of the prior art disclosure. [Editor Note: This MPEP section is only applicable to applications subject to examination under the ®rst The AIA de®nes the term ªeffective ®ling dateº for inventor to ®le (FITF) provisions of the AIA as set a claimed invention in a patent or application for forth in 35 U.S.C. 100 (note). See MPEP § 2159 et patent (other than a reissue application or reissued seq. to determine whether an application is subject patent) as the earliest of: (1) the actual ®ling date of to examination under the FITF provisions, and the patent or the application for the patent containing MPEP § 2131-MPEP § 2138 for examination of the claimed invention; or (2) the ®ling date of the applications subject to pre-AIA 35 U.S.C. 102.] earliest application for which the patent or application is entitled, as to such invention, to a right of priority or the bene®t of an earlier ®ling date

2100-203 Rev. 07.2015, October 2015 § 2152.02(a) MANUAL OF PATENT EXAMINING PROCEDURE

Prior art documents and activities which may Although an invention may be described in a patent preclude patentability are set forth in AIA 35 U.S.C. and not claimed therein, the grant date would also 102(a)(1). Such documents and activities include be the applicable prior art date for purposes of prior patenting of the claimed invention, descriptions relying on the subject matter disclosed therein as of the claimed invention in a printed publication, ªdescribed in a printed publication,º provided that public use of the claimed invention, placing the the patent was made available to the public on its claimed invention on sale, and otherwise making the grant date. Note that a U.S. patent that issues after claimed invention available to the public. MPEP §§ the effective ®ling date of a claimed invention and 2154.02(a)±2152.02(f) discuss each prior art is not available as prior art against that invention document and activity that might preclude under AIA 35 U.S.C. 102(a)(1) could be available patentability under AIA in turn.35 U.S.C. 102(a)(1) as prior art under AIA 35 U.S.C. 102(a)(2).

2152.02(a) Patented [R-11.2013] 2152.02(b) Described in a Printed Publication [R-11.2013] [Editor Note: This MPEP section is only applicable to applications subject to examination under the ®rst [Editor Note: This MPEP section is only applicable inventor to ®le (FITF) provisions of the AIA as set to applications subject to examination under the ®rst forth in 35 U.S.C. 100 (note). See MPEP § 2159 et inventor to ®le (FITF) provisions of the AIA as set seq. to determine whether an application is subject forth in 35 U.S.C. 100 (note). See MPEP § 2159 et to examination under the FITF provisions, and seq. to determine whether an application is subject MPEP § 2131-MPEP § 2138 for examination of to examination under the FITF provisions, and applications subject to pre-AIA 35 U.S.C. 102.] MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] AIA 35 U.S.C. 102(a)(1) indicates that a prior patent of a claimed invention will preclude the grant of a If a claimed invention is described in a patent, subsequent patent on the claimed invention. This published patent application, or printed publication, means that if a claimed invention was patented in such a document may be available as prior art under this or a foreign country before the effective ®ling AIA 35 U.S.C. 102(a)(1). Both pre-AIA 35 U.S.C. date of the claimed invention, AIA 35 U.S.C. 102(a) and (b) and AIA 35 U.S.C. 102(a)(1) use the 102(a)(1) precludes the grant of a patent on the term ªdescribedº with respect to an invention in a claimed invention. The effective date of the patent prior art printed publication. Likewise, AIA 35 for purposes of determining whether the patent U.S.C. 102(a)(2) uses that term with respect to U.S. quali®es as prior art under AIA 35 U.S.C. 102(a)(1) patents, U.S. patent application publications, and is the grant date of the patent. There is an exception WIPO published applications. Thus, the Of®ce does to this rule if the patent is secret as of the date the not view the AIA as changing the extent to which a rights are awarded. See In re Ekenstam, 256 F.2d claimed invention must be described for a prior art 321, 323, 118 USPQ 349, 353 (CCPA 1958); see document to anticipate the claimed invention under also MPEP § 2126.01. In such situations, the patent 35 U.S.C. 102. is available as prior art as of the date the patent was made available to the public by being laid open for While the conditions for patentability of AIA 35 public inspection or disseminated in printed form. U.S.C. 112(a) require a written description of the See In re Carlson, 983 F.2d 1032, 1037, 25 USPQ2d claimed invention that would have enabled a person 1207 (Fed. Cir. 1992); see also MPEP § 2126. The skilled in the art to make as well as use the invention, phrase ªpatentedº in AIA 35 U.S.C. 102(a)(1) has the prior art provisions of AIA 35 U.S.C. 102(a)(1) the same meaning as ªpatentedº in pre-AIA 35 and (a)(2) require only that the claimed invention is U.S.C. 102(a) and (b). For a discussion of ªpatentedº ªdescribedº in a prior art document (patent, as used in pre-AIA 35 U.S.C. 102(a) and (b), see published patent application, or printed publication). generally MPEP § 2126. The two basic requirements that must be met by a prior art document in order to describe a claimed invention such that it is anticipated under AIA 35

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U.S.C. 102 are the same as those under pre-AIA 35 There is an additional important distinction between U.S.C. 102. First, ªeach and every element of the the written description that is necessary to support claimed inventionº must be disclosed either a claim under 35 U.S.C. 112(a) and the description explicitly or inherently, and the elements must be suf®cient to anticipate the subject matter of the claim ªarranged or combined in the same way as in the under AIA 35 U.S.C. 102(a)(1) or (a)(2). See claim.º See In re Gleave, 560 F.3d 1331, 1334, 90 Rasmussen v. SmithKline Beecham Corp., 413 F.3d USPQ2d 1235, 1237-38 (Fed. Cir. 2009), citing Eli 1318, 75 USPQ2d 1297 (Fed. Cir. 2005). To provide Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 support for a claim under 35 U.S.C. 112(a), it is F.3d 1369, 1375, 81 USPQ2d 1324,1328 (Fed. Cir. necessary that the speci®cation describe and enable 2006); Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d the entire scope of the claimed invention. However, 1359, 1370, 88 USPQ2d 1751, 1759 (Fed. Cir. in order for a prior art document to describe a 2008); In re Bond, 910 F.2d 831, 832-33, 15 claimed invention under AIA 35 U.S.C. 102(a)(1) USPQ2d 1566, 1567 (Fed. Cir. 1990). Second, a or (a)(2), the prior art document need only describe person of ordinary skill in the art must have been and enable one skilled in the art to make a single enabled to make the invention without undue species or embodiment of the claimed invention. See experimentation. See Gleave, 560 F.3d at 1334, 90 Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562, USPQ2d at 1238 (citing Impax Labs., Inc. v. Aventis 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) (ªAs the Pharms. Inc., 545 F.3d 1312, 1314, 88 USPQ2d court pointed out, `the description of a single 1381, 1383 (Fed. Cir. 2008), and In re LeGrice, 301 embodiment of broadly claimed subject matter F.2d 929, 940-44, 133 USPQ 365, 372 (CCPA constitutes a description of the invention for 1962)). Thus, in order for a prior art document to anticipation purposes..., whereas the same describe a claimed invention such that it is information in a speci®cation might not alone be anticipated under AIA 35 U.S.C. 102(a)(1) or (a)(2), enough to provide a description of that invention for it must disclose all elements of the claimed invention purposes of adequate disclosure.'º) (quoting In re arranged as they are in the claim, and also provide Lukach, 442 F.2d 967, 970, 169 USPQ 795, 797 suf®cient guidance to enable a person skilled in the (CCPA 1971)); see also In re Van Langenhoven, art to make the claimed invention. There is, however, 458 F.2d 132, 173 USPQ 426 (CCPA 1972), and In no requirement that a prior art document meet the re Ruscetta, 255 F.2d 687, 118 USPQ 101 (CCPA ªhow to useº requirement of 35 U.S.C. 112(a) in 1958). order to qualify as prior art. See Gleave, 560 F.3d at 1334, 90 USPQ2d at 1237-38; see also In re An anticipatory description it is not required in order Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, for a disclosure to qualify as prior art, unless the 1673 (Fed. Cir. 1992) (holding that a claimed disclosure is being used as the basis for an compound was anticipated even though the prior art anticipation rejection. In accordance with pre-AIA reference did not disclose a use for the compound); case law concerning obviousness, a disclosure may Schering Corp. v. Geneva Pharms., Inc., 339 F.3d be cited for all that it would reasonably have made 1373, 1380-81, 67 USPQ2d 1664, 1670 (Fed. Cir. known to a person of ordinary skill in the art. Thus, 2003) (pointing out that actually reducing the the description requirement of AIA 35 U.S.C. invention to practice is not necessary in order for a 102(a)(1) and (a)(2) does not preclude an examiner prior art reference to anticipate); Impax Labs, 468 from applying a disclosure in an obviousness F.3d at 1382 (stating that ªproof of ef®cacy is not rejection under AIA 35 U.S.C. 103 simply because required for a prior art reference to be enabling for the disclosure is not adequate to anticipate the purposes of anticipationº). Furthermore, compliance claimed invention. with the ªhow to makeº requirement is judged from the viewpoint of a person of ordinary skill in the art, 2152.02(c) In Public Use [R-11.2013] and thus does not require that the prior art document explicitly disclose information within the knowledge Under pre-AIA 35 U.S.C. 102(b), an invention that of such a person. See In re Donohue, 766 F.2d 531, was ªin public useº precluded the grant of a patent 533, 226 USPQ 619, 621 (Fed. Cir. 1985). only if such public use occurred ªin this country.º See MPEP § 2133.03(d).

2100-205 Rev. 07.2015, October 2015 § 2152.02(d) MANUAL OF PATENT EXAMINING PROCEDURE

Under AIA 35 U.S.C. 102(a)(1), there is no Further, under pre-AIA 35 U.S.C. 102(a), ªin order geographic limitation on where prior public use or to invalidate a patent based on prior knowledge or public availability occurs. Furthermore, a public use useº by another in this country prior to the patent©s would need to occur before the effective ®ling date priority date, ªthat knowledge or use must have been of the claimed invention to constitute prior art under available to the public.º See Woodland Trust, 148 AIA 35 U.S.C. 102(a)(1). F.3d at 1370, 47 USPQ2d at 1366 and MPEP § 2132, subsection I. Patent-defeating ªuse,º under pre-AIA The pre-AIA case law also indicates that a public 35 U.S.C. 102(a) includes only that ªuse which is use will bar patentability if the public use occurs accessible to the public.º See id. (quoting Carella before the critical date and the invention is ready for v. Starlight Archery, 804 F.2d 135, 139, 231 USPQ patenting. Under pre-AIA 35 U.S.C. 102(b), the 644, 646 (Fed. Cir. 1986)). critical date is the date that is one year prior to the date of application for patent in the United States. As discussed previously, public use under AIA 35 See Invitrogen Corp. v. Biocrest Manufacturing. U.S.C. 102(a)(1) is limited to those uses that are L.P., 424 F.3d 1374, 1379-80, 76 USPQ2d 1741, available to the public. The public use provision of 1744 (Fed. Cir. 2005) and MPEP § 2133. Under AIA 35 U.S.C. 102(a)(1) thus has the same pre-AIA 35 U.S.C. 102(b), the uses of an invention substantive scope, with respect to uses by either the before the patent©s critical date that constitute a inventor or a third party, as public uses under ªpublic useº fall into two categories: the use either pre-AIA 35 U.S.C. 102(b) by unrelated third parties ª(1) was accessible to the public; or (2) was or others under pre-AIA 35 U.S.C. 102(a). commercially exploited.º See American Seating Co. v. USSC Group, Inc., 514 F.3d 1262, 1267, 85 As also discussed previously, once an examiner USPQ2d 1683, 1685 (Fed. Cir. 2008) and MPEP § becomes aware that a claimed invention has been 2133.03(a). Whether a use is a pre-AIA 35 U.S.C. the subject of a potentially public use, the examiner 102(b) public use also depends on who is making should require the applicant to provide information the use of the invention. ª[W]hen an asserted prior showing that the use did not make the claimed use is not that of the applicant, [pre-AIA 35 U.S.C.] process accessible to the public. 102(b) is not a bar when that prior use or knowledge is not available to the public.º See Woodland Trust 2152.02(d) On Sale [R-11.2013] v. Flowertree Nursery, Inc., 148 F.3d 1368, 1371, 47 USPQ2d 1363, 1366 (Fed. Cir. 1998). In other [Editor Note: This MPEP section is only applicable words, a use by a third party who did not obtain the to applications subject to examination under the ®rst invention from the inventor named in the application inventor to ®le (FITF) provisions of the AIA as set or patent is an invalidating use under pre-AIA 35 forth in 35 U.S.C. 100 (note). See MPEP § 2159 et U.S.C. 102(b) only if it falls into the ®rst category: seq. to determine whether an application is subject That the use was accessible to the public. See MPEP to examination under the FITF provisions, and § 2133.03(a), subsection II.C. On the other hand, MPEP § 2133.03 et seq. for information about on ªan inventor©s own prior commercial use, albeit kept sale in regard to applications subject to pre-AIA 35 secret, may constitute a public use or sale under U.S.C. 102.] [pre-AIA 35 U.S.C.] 102(b), barring him from obtaining a patent.º See Woodland Trust, 148 F.3d The pre-AIA case law indicates that on sale activity at 1370, 47 USPQ2d at 1366 and MPEP § will bar patentability if the claimed invention was: 2133.03(a), subsection II.A. Also, an inventor creates (1) the subject of a commercial sale or offer for sale, a public use bar under pre-AIA 35 U.S.C. 102(b) not primarily for experimental purposes; and (2) when the inventor shows the invention to, or allows ready for patenting. See Pfaff v. Wells Elecs., Inc., it to be used by, another person who is ªunder no 525 U.S. 55, 67, 48 USPQ2d 1641, 1646-47 (1998). limitation, restriction, or obligation of Contract law principles apply in order to determine con®dentialityº to the inventor. See American whether a commercial sale or offer for sale occurred. Seating, 514 F.3d at 1267 and MPEP § 2133.03(a), In addition, the enablement inquiry is not applicable subsection II.B. to the question of whether a claimed invention is

Rev. 07.2015, October 2015 2100-206 PATENTABILITY § 2152.02(f)

ªon saleº under pre-AIA 35 U.S.C. 102(b). See the publicº before its effective ®ling date. This Epstein, 32 F.3d at 1568, 31 USPQ2d at 1824. The ªcatch-allº provision permits decision makers to phrase ªon saleº in AIA 35 U.S.C. 102(a)(1) is focus on whether the disclosure was ªavailable to treated as having the same meaning as ªon saleº in the public,º rather than on the means by which the pre-AIA 35 U.S.C. 102(b), except that the sale must claimed invention became available to the public or make the invention available to the public. For a whether a disclosure constitutes a ªprinted discussion of ªon saleº as used in pre-AIA 35 U.S.C. publicationº or falls within another category of prior 102(b), see generally MPEP § 2133.03(b) et seq. art as de®ned in AIA 35 U.S.C. 102(a)(1). The availability of the subject matter to the public may Under pre-AIA 35 U.S.C. 102(b), if an invention arise in situations such as a student thesis in a was ªon sale,º patentability was precluded only if university library (see, e.g., In re Cronyn, 890 F.2d the invention was on sale ªin this country.º See 1158, 13 USPQ2d 1070 (Fed. Cir. 1989); In re Hall, MPEP § 2133.03(d). Under AIA 35 U.S.C. 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986); In 102(a)(1), there is no geographic limitation on where re Bayer, 568 F.2d 1357, 196 USPQ 670 (CCPA the sale or offer for sale may occur. When 1978) and MPEP § 2128.01, subsection I.); a poster formulating a rejection, Of®ce personnel should display or other information disseminated at a consider evidence of sales activity, regardless of scienti®c meeting (see, e.g., In re Klopfenstein, 380 where the sale activity took place. F.3d 1345, 72 USPQ2d 1117 (Fed. Cir. 2004), Massachusetts Institute of Technology v. AB Fortia, The pre-AIA 35 U.S.C. 102(b) ªon saleº provision 774 F.2d 1104, 227 USPQ 428 (Fed. Cir. 1985) and has been interpreted as including commercial activity MPEP § 2128.01, subsection IV.); subject matter in even if the activity is secret. See MPEP § 2133.03(b), a laid-open patent application or patent (see, e.g., subsection III.A. AIA 35 U.S.C. 102(a)(1) uses the In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA same ªon saleº term as pre-AIA 35 U.S.C. 102(b). 1981); see also Bruckelmyer v. Ground Heaters, The ªor otherwise available to the publicº residual Inc., 445 F.3d 1374, 78 USPQ2d 1684 (Fed. Cir. clause of AIA 35 U.S.C. 102(a)(1), however, 2006)); a document electronically posted on the indicates that AIA 35 U.S.C. 102(a)(1) does not Internet (see, e.g., Voter Veri®ed, Inc. v. Premier cover secret sales or offers for sale. For example, an Election Solutions, Inc., 698 F.3d 1374, 104 USPQ2d activity (such as a sale, offer for sale, or other 1553 (Fed. Cir. 2012), In re Lister, 583 F.3d 1307, commercial activity) is secret (non-public) if it is 92 USPQ2d 1225 (Fed. Cir. 2009), SRI Int©l, Inc. v. among individuals having an obligation of Internet Sec. Sys., Inc., 511 F.3d 1186, 85 USPQ2d con®dentiality to the inventor. 1489 (Fed. Cir. 2008), and MPEP § 2128); or a commercial transaction that does not constitute a 2152.02(e) Otherwise Available to the Public sale under the Uniform Commercial Code (see, e.g., [R-11.2013] Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 59 USPQ2d 1121 (Fed. Cir. 2001) and MPEP § 2133.03(e)(1)). Even if a document or other [Editor Note: This MPEP section is only applicable disclosure is not a printed publication, or a to applications subject to examination under the ®rst transaction is not a sale, either may be prior art under inventor to ®le (FITF) provisions of the AIA as set the ªotherwise available to the publicº provision of forth in 35 U.S.C. 100 (note). See MPEP § 2159 et AIA 35 U.S.C. 102(a)(1), provided that the claimed seq. to determine whether an application is subject invention is made suf®ciently available to the public. to examination under the FITF provisions, and MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] 2152.02(f) No Requirement of "By Others" [R-11.2013] AIA 35 U.S.C. 102(a)(1) provides a ªcatch-allº provision, which de®nes a new additional category [Editor Note: This MPEP section is only applicable of potential prior art not provided for in pre-AIA 35 to applications subject to examination under the ®rst U.S.C. 102. Speci®cally, a claimed invention is not inventor to ®le (FITF) provisions of the AIA as set entitled to a patent if it was ªotherwise available to forth in 35 U.S.C. 100 (note). See MPEP § 2159 et

2100-207 Rev. 07.2015, October 2015 § 2152.03 MANUAL OF PATENT EXAMINING PROCEDURE

seq. to determine whether an application is subject (Fed. Cir.1988). For a discussion of admissions as to examination under the FITF provisions, and prior art, see generally MPEP § 2129. MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] 2152.04 The Meaning of "Disclosure" [R-11.2013] A key difference between pre-AIA 35 U.S.C. 102(a) and AIA 35 U.S.C. 102(a)(1) is the requirement in [Editor Note: This MPEP section is only applicable pre-AIA 35 U.S.C. 102(a) that the prior art relied on to applications subject to examination under the ®rst was ªby others.º Under AIA 35 U.S.C. 102(a)(1), inventor to ®le (FITF) provisions of the AIA as set there is no requirement that the prior art relied upon forth in 35 U.S.C. 100 (note). See MPEP § 2159 et be by others. Thus, any prior art which falls under seq. to determine whether an application is subject AIA 35 U.S.C. 102(a)(1) need not be by another to to examination under the FITF provisions, and constitute potentially available prior art. However, MPEP § 2131-MPEP § 2138 for examination of disclosures of the subject matter made one year or applications subject to pre-AIA 35 U.S.C. 102.] less before the effective ®ling date of the claimed invention by the inventor or a joint inventor or The AIA does not de®ne the term ªdisclosure,º and another who obtained the subject matter directly or AIA 35 U.S.C. 102(a) does not use the term indirectly from the inventor or a joint inventor may ªdisclosure.º AIA 35 U.S.C. 102(b)(1) and (b)(2), fall within an exception under AIA 35 U.S.C. however, each state conditions under which a 102(b)(1) to AIA 35 U.S.C. 102(a)(1). ªdisclosureº that otherwise falls within AIA 35 U.S.C. 102(a)(1) or 102(a)(2) is not prior art under 2152.03 Admissions [R-11.2013] AIA 35 U.S.C. 102(a)(1) or 102(a)(2). Thus, the Of®ce is treating the term ªdisclosureº as a generic [Editor Note: This MPEP section is only applicable expression intended to encompass the documents to applications subject to examination under the ®rst and activities enumerated in AIA 35 U.S.C. 102(a) inventor to ®le (FITF) provisions of the AIA as set (i.e., being patented, described in a printed forth in 35 U.S.C. 100 (note). See MPEP § 2159 et publication, in public use, on sale, or otherwise seq. to determine whether an application is subject available to the public, or being described in a U.S. to examination under the FITF provisions, and patent, U.S. patent application publication, or WIPO MPEP § 2131-MPEP § 2138 for examination of published application). applications subject to pre-AIA 35 U.S.C. 102.] 2153 Prior Art Exceptions Under 35 U.S.C. The Of®ce will continue to treat admissions by the 102(b)(1) to AIA 35 U.S.C. 102(a)(1) applicant as prior art under the AIA. A statement by [R-11.2013] an applicant in the speci®cation or made during prosecution identifying the work of another as ªprior [Editor Note: This MPEP section is only applicable artº is an admission which can be relied upon for to applications subject to examination under the ®rst both anticipation and obviousness determinations, inventor to ®le (FITF) provisions of the AIA as set regardless of whether the admitted prior art would forth in 35 U.S.C. 100 (note). See MPEP § 2159 et otherwise qualify as prior art under AIA 35 U.S.C. seq. to determine whether an application is subject 102. See Riverwood Int©l Corp. v. R.A. Jones & Co., to examination under the FITF provisions, and 324 F.3d 1346, 1354, 66 USPQ2d 1331, 1337 (Fed. MPEP § 2131-MPEP § 2138 for examination of Cir. 2003); Constant v. Advanced Micro-Devices applications subject to pre-AIA 35 U.S.C. 102.] Inc., 848 F.2d 1560, 1570, 7 USPQ2d 1057, 1063 See MPEP § 2153.01 for prior art exceptions based on grace period inventor or inventor-originated disclosures as provided for under AIA 35 U.S.C. 102(b)(1)(A). See MPEP § 2153.02 for prior art

Rev. 07.2015, October 2015 2100-208 PATENTABILITY § 2153.01(a)

exceptions based on inventor or inventor-originated disclosuresº). MPEP § 2152.01 discusses the prior public disclosures. ªeffective ®ling dateº of a claimed invention.

2153.01 Prior Art Exception Under AIA 35 2153.01(a) Grace Period Inventor Disclosure U.S.C. 102(b)(1)(A) To AIA 35 U.S.C. Exception [R-11.2013] 102(a)(1) (Grace Period Inventor Or Inventor-Originated Disclosure Exception) [Editor Note: This MPEP section is only applicable [R-11.2013] to applications subject to examination under the ®rst inventor to ®le (FITF) provisions of the AIA as set [Editor Note: This MPEP section is only applicable forth in 35 U.S.C. 100 (note). See MPEP § 2159 et to applications subject to examination under the ®rst seq. to determine whether an application is subject inventor to ®le (FITF) provisions of the AIA as set to examination under the FITF provisions, and forth in 35 U.S.C. 100 (note). See MPEP § 2159 et MPEP § 2131-MPEP § 2138 for examination of seq. to determine whether an application is subject applications subject to pre-AIA 35 U.S.C. 102.] to examination under the FITF provisions, and MPEP § 2131-MPEP § 2138 for examination of AIA 35 U.S.C. 102(b)(1)(A) ®rst provides that a applications subject to pre-AIA 35 U.S.C. 102.] disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) may be AIA 35 U.S.C. 102(b)(1)(A) provides exceptions to disquali®ed as prior art if the disclosure is made: (1) the prior art provisions of AIA 35 U.S.C. 102(a)(1). one year or less before the effective ®ling date of These exceptions limit the use of an inventor©s own the claimed invention; and (2) by the inventor or a work as prior art, when the inventor©s own work has joint inventor. Thus, a disclosure that would been publicly disclosed by the inventor, a joint otherwise qualify as prior art under AIA 35 U.S.C. inventor, or another who obtained the subject matter 102(a)(1) will not be treated as prior art by Of®ce directly or indirectly from the inventor or joint personnel if the disclosure is made one year or less inventor not more than one year before the effective before the effective ®ling date of the claimed ®ling date of the claimed invention. AIA 35 U.S.C. invention, and the evidence shows that the disclosure 102(b)(1)(A) provides that a disclosure which would is by the inventor or a joint inventor. What evidence otherwise qualify as prior art under AIA 35 U.S.C. is necessary to show that the disclosure is by the 102(a)(1) is not prior art if the disclosure was made: inventor or a joint inventor requires case-by-case (1) One year or less before the effective ®ling date treatment, depending upon whether it is apparent of the claimed invention; and (2) by the inventor or from the disclosure itself or the patent application a joint inventor, or by another who obtained the speci®cation that the disclosure is by the inventor subject matter directly or indirectly from the inventor or a joint inventor. or joint inventor. MPEP § 2153.01(a) discusses issues pertaining to disclosures within the grace Of®ce personnel will not apply a disclosure as prior period by the inventor or a joint inventor (ªgrace art under AIA 35 U.S.C. 102(a)(1) if it is apparent period inventor disclosuresº) and MPEP § from the disclosure itself that it is by the inventor or 2153.01(b) discusses issues pertaining to disclosures a joint inventor. Speci®cally, Of®ce personnel will within the grace period by another who obtained the not apply a disclosure as prior art under AIA 35 subject matter directly or indirectly from the inventor U.S.C. 102(a)(1) if the disclosure: (1) was made one or joint inventor (ªgrace period inventor-originated year or less before the effective ®ling date of the claimed invention; (2) names the inventor or a joint inventor as an author or an inventor; and (3) does not name additional persons as authors on a printed publication or joint inventors on a patent. This means that in circumstances where an application names additional persons as joint inventors relative to the persons named as authors in the publication (e.g., the application names as joint inventors A, B, and

2100-209 Rev. 07.2015, October 2015 § 2153.01(b) MANUAL OF PATENT EXAMINING PROCEDURE

C, and the publication names as authors A and B), made by the inventor or a joint inventor under the and the publication is one year or less before the exception of AIA 35 U.S.C. 102(b)(1)(A) for a grace effective ®ling date, it is apparent that the disclosure period inventor disclosure. is a grace period inventor disclosure, and the publication would not be treated as prior art under 2153.01(b) Grace Period Inventor-Originated AIA 35 U.S.C. 102(a)(1). If, however, the Disclosure Exception [R-11.2013] application names fewer joint inventors than a publication (e.g., the application names as joint [Editor Note: This MPEP section is only applicable inventors A and B, and the publication names as to applications subject to examination under the ®rst authors A, B and C), it would not be readily apparent inventor to ®le (FITF) provisions of the AIA as set from the publication that it is by the inventor (i.e., forth in 35 U.S.C. 100 (note). See MPEP § 2159 et the inventive entity) or a joint inventor and the seq. to determine whether an application is subject publication would be treated as prior art under AIA to examination under the FITF provisions, and 35 U.S.C. 102(a)(1). MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] Applicants can include a statement designating any grace period inventor disclosures in the speci®cation AIA 35 U.S.C. 102(b)(1)(A) also provides that a See 37 CFR 1.77(b)(6) and MPEP § 608.01(a). An disclosure which would otherwise qualify as prior applicant is not required to use the format speci®ed art under AIA 35 U.S.C. 102(a)(1) may be in 37 CFR 1.77 or identify any prior disclosures by disquali®ed as prior art if the disclosure was made: the inventor or a joint inventor (unless necessary to (1) one year or less before the effective ®ling date overcome a rejection), but identifying any prior of the claimed invention; and (2) by another who disclosures by the inventor or a joint inventor may obtained the subject matter directly or indirectly expedite examination of the application and save from the inventor or a joint inventor. Thus, if a prior applicants (and the Of®ce) the costs related to an disclosure upon which the rejection is based is by Of®ce action and reply. If the patent application someone who obtained the subject matter from the speci®cation contains a speci®c reference to a grace inventor or a joint inventor, and was made one year period inventor disclosure, the Of®ce will consider or less before the effective ®ling date of the claimed it apparent from the speci®cation that the prior invention, the applicant may establish by way of an disclosure is by the inventor or a joint inventor, af®davit or declaration that the prior disclosure is provided that the prior disclosure does not name not prior art under AIA 35 U.S.C. 102(a)(1) because additional authors or joint inventors and there is no the prior disclosure was by another who obtained other evidence to the contrary. The applicant may the subject matter directly or indirectly from the also provide a copy of the grace period inventor inventor or a joint inventor. MPEP § 718 and MPEP disclosure (e.g., copy of a printed publication). § 2155.03 discuss the use of af®davits or declarations to show that a prior disclosure was by another who The Of®ce has provided a mechanism for ®ling an obtained the subject matter disclosed directly or af®davit or declaration (under 37 CFR 1.130) to indirectly from the inventor or a joint inventor under establish that a disclosure is not prior art under AIA the exception of AIA 35 U.S.C. 102(b)(1)(A) for a 35 U.S.C. 102(a) due to an exception in AIA 35 grace period inventor-originated disclosure. U.S.C. 102(b). See MPEP § 717. In the situations in which it is not apparent from the prior disclosure or 2153.02 Prior Art Exception Under AIA 35 the patent application speci®cation that the prior U.S.C. 102(b)(1)(B) to AIA 35 U.S.C. disclosure is by the inventor or a joint inventor, the applicant may establish by way of an af®davit or 102(a)(1) (Inventor Or Inventor-Originated declaration that a grace period disclosure is not prior Prior Public Disclosure Exception) art under AIA 35 U.S.C. 102(a)(1) because the prior [R-11.2013] disclosure was by the inventor or a joint inventor. MPEP § 2155.01 discusses the use of af®davits or [Editor Note: This MPEP section is only applicable declarations to show that the prior disclosure was to applications subject to examination under the ®rst

Rev. 07.2015, October 2015 2100-210 PATENTABILITY § 2153.02

inventor to ®le (FITF) provisions of the AIA as set matter disclosed directly or indirectly from the forth in 35 U.S.C. 100 (note). See MPEP § 2159 et inventor or a joint inventor. seq. to determine whether an application is subject to examination under the FITF provisions, and The exception in AIA 35 U.S.C. 102(b)(1)(B) applies MPEP § 2131-MPEP § 2138 for examination of if the ªsubject matter disclosed [in the intervening applications subject to pre-AIA 35 U.S.C. 102.] disclosure] had, before such [intervening] disclosure, been publicly disclosed by the inventor or a joint AIA 35 U.S.C. 102(b)(1)(B) provides additional inventor (or another who obtained the subject matter exceptions to the prior art provisions of AIA 35 directly or indirectly from the inventor or joint U.S.C. 102(a)(1). These exceptions disqualify a inventor).º See 35 U.S.C. 102(b)(1)(B). The disclosure of subject matter that occurs after the exception in AIA 35 U.S.C. 102(b)(1)(B) focuses subject matter had been publicly disclosed by the on the ªsubject matterº that had been publicly inventor, a joint inventor, or another who obtained disclosed by the inventor or a joint inventor (or the subject matter directly or indirectly from the another who obtained the subject matter directly or inventor or joint inventor. Speci®cally, AIA 35 indirectly from the inventor or joint inventor). There U.S.C. 102(b)(1)(B) provides that a disclosure which is no requirement under AIA 35 U.S.C. 102(b)(1)(B) would otherwise qualify as prior art under AIA 35 that the mode of disclosure by the inventor or a joint U.S.C. 102(a)(1) (patent, printed publication, public inventor (or another who obtained the subject matter use, sale, or other means of public availability) may directly or indirectly from the inventor or joint be disquali®ed as prior art if: (1) the disclosure was inventor) be the same as the mode of disclosure of made one year or less before the effective ®ling date the intervening grace period disclosure (e.g., of the claimed invention; and (2) the subject matter patenting, publication, public use, sale activity). disclosed had been previously publicly disclosed by There is also no requirement that the disclosure by the inventor, a joint inventor, or another who the inventor or a joint inventor be a verbatim or obtained the subject matter directly or indirectly ipsissimis verbis disclosure of the intervening grace from the inventor or joint inventor. The previous period disclosure. See In re Kao, 639 F.3d 1057, public disclosure of the subject matter by the 1066 98 USPQ2d 1799, 1806 (Fed. Cir. 2011) inventor, a joint inventor, or another who obtained (subject matter does not change as a function of how the subject matter directly or indirectly from the one chooses to describe it). What is required for inventor or joint inventor typically will be a subject matter in an intervening grace period disclosure within the one-year grace period (i.e., be disclosure to be excepted under AIA 35 U.S.C. either a grace period inventor disclosure by the 102(b)(1)(B) is that the subject matter of the inventor or a joint inventor or be a grace period disclosure to be disquali®ed as prior art must have inventor-originated disclosure by another who been previously publicly disclosed by the inventor obtained the subject matter directly or indirectly or a joint inventor (or by another who obtained the from the inventor or joint inventor). However, if the subject matter therefrom). previous public disclosure of the subject matter was made outside the grace period, it would qualify as The exception in AIA 35 U.S.C. 102(b)(1)(B) applies prior art under AIA 35 U.S.C. 102(a)(1) that could to the subject matter in the intervening grace period not be disquali®ed under AIA 35 U.S.C. disclosure being relied upon as prior art for a 102(b)(1)(A). MPEP § 2152.01 discusses the rejection under AIA 35 U.S.C. 102(a)(1) (an ªeffective ®ling dateº of a claimed invention. MPEP intervening disclosure) that was also publicly § 2155.02 discusses the use of af®davits or disclosed by the inventor or a joint inventor (or by declarations to show that the subject matter disclosed another who obtained the subject matter therefrom) had, before such disclosure, been publicly disclosed before such intervening disclosure. The subject by the inventor or a joint inventor, and MPEP § matter of an intervening grace period disclosure that 2155.03 discusses the use of af®davits or is not in the inventor or inventor-originated prior declarations to show that the disclosure was made, public disclosure is available as prior art under AIA or that the subject matter had been previously 35 U.S.C. 102(a)(1). For example, if the inventor or publicly disclosed, by another obtained the subject a joint inventor had publicly disclosed elements A,

2100-211 Rev. 07.2015, October 2015 § 2154 MANUAL OF PATENT EXAMINING PROCEDURE

B, and C, and a subsequent intervening grace period subject matter of the subsequent intervening grace disclosure discloses elements A, B, C, and D, then period disclosure. only element D of the intervening grace period disclosure is available as prior art under AIA 35 2154 Provisions Pertaining to Subject Matter U.S.C. 102(a)(1). in a U.S. Patent or Application Effectively Filed Before the Effective Filing Date of the In addition, if subject matter of an intervening grace Claimed Invention [R-11.2013] period disclosure is simply a more general description of the subject matter in the inventor or [Editor Note: This MPEP section is only applicable inventor-originated prior public disclosure, the to applications subject to examination under the ®rst exception in AIA 35 U.S.C. 102(b)(1)(B) applies to inventor to ®le (FITF) provisions of the AIA as set such subject matter of the intervening grace period forth in 35 U.S.C. 100 (note). See MPEP § 2159 et disclosure. For example, if the inventor or a joint seq. to determine whether an application is subject inventor had publicly disclosed a species, and a to examination under the FITF provisions, and subsequent intervening grace period disclosure MPEP § 2131-MPEP § 2138 for examination of discloses a genus (i.e., provides a more generic applications subject to pre-AIA 35 U.S.C. 102.] disclosure of the species), the intervening grace period disclosure of the genus is not available as AIA 35 U.S.C. 102(a)(2) sets forth three types of prior art under AIA 35 U.S.C. 102(a)(1). Conversely, U.S. patent documents that are available as prior art if the inventor or a joint inventor had publicly as of the date they were effectively ®led with respect disclosed a genus, and a subsequent intervening to the subject matter relied upon in the document if grace period disclosure discloses a species, the they name another inventor. See MPEP §§ 2151, intervening grace period disclosure of the species 2154.01, and 2154.01(a) for a discussion of the types would be available as prior art under AIA 35 U.S.C. of patent documents that qualify as prior art under 102(a)(1). Likewise, if the inventor or a joint 35 U.S.C. 102(a)(2). See MPEP § 2154.02 et seq. inventor had publicly disclosed a species, and a for prior art exceptions under 35 U.S.C. 102(b)(2) subsequent intervening grace period disclosure to AIA 35 U.S.C. 102(a)(2). discloses an alternative species not also disclosed by the inventor or a joint inventor, the intervening grace period disclosure of the alternative species 2154.01 Prior Art Under AIA 35 U.S.C. would be available as prior art under AIA 35 U.S.C. 102(a)(2) ªU.S. Patent Documentsº 102(a)(1). [R-11.2013]

Finally, AIA 35 U.S.C. 102(b)(1)(B) does not discuss [Editor Note: This MPEP section is only applicable ªthe claimed inventionº with respect to either the to applications subject to examination under the ®rst subject matter disclosed by the inventor or a joint inventor to ®le (FITF) provisions of the AIA as set inventor, or the subject matter of the subsequent forth in 35 U.S.C. 100 (note). See MPEP § 2159 et intervening grace period disclosure. Any inquiry seq. to determine whether an application is subject with respect to the claimed invention is whether or to examination under the FITF provisions, and not the subject matter in the prior art disclosure being MPEP § 2131-MPEP § 2138 for examination of relied upon anticipates or renders obvious the applications subject to pre-AIA 35 U.S.C. 102.] claimed invention. A determination of whether the exception in AIA 35 U.S.C. 102(b)(1)(B) is AIA 35 U.S.C. 102(a)(2) sets forth three types of applicable to subject matter in an intervening grace patent documents that are available as prior art as of period disclosure does not involve a comparison of the date they were effectively ®led with respect to the subject matter of the claimed invention to either the subject matter relied upon in the document if the subject matter in the inventor or they name another inventor: (1) U.S. patents; (2) inventor-originated prior public disclosure, or to the U.S. patent application publications; and (3) certain WIPO published applications. These documents are referred to collectively as ªU.S. patent documents.º

Rev. 07.2015, October 2015 2100-212 PATENTABILITY § 2154.01(b)

These documents may have different prior art effects U.S.C. 102(a)(2). This differs from the treatment of under pre-AIA 35 U.S.C. 102(e) than under AIA 35 a WIPO published application under pre-AIA 35 U.S.C. 102(a)(2). Note that a U.S. patent document U.S.C. 102(e), where a WIPO published application may also be prior art under AIA 35 U.S.C. 102(a)(1) is treated as a U.S. patent application publication if its issue or publication date is before the effective only if the PCT application was ®led on or after ®ling date of the claimed invention in question. November 29, 2000, designated the United States, and is published under PCT Article 21(2) in the If the issue date of the U.S. patent or publication English language. See MPEP § 2136.03, subsection date of the U.S. patent application publication or II. WIPO published application is not before the effective ®ling date of the claimed invention, it may 2154.01(b) Determining When Subject be applicable as prior art under AIA 35 U.S.C. Matter Was Effectively Filed Under AIA 35 102(a)(2) if it was ªeffectively ®ledº before the U.S.C. 102(d) [R-11.2013] effective ®ling date of the claimed invention in question with respect to the subject matter relied [Editor Note: This MPEP section is only applicable upon to reject the claim. MPEP § 2152.01 discusses to applications subject to examination under the ®rst the ªeffective ®ling dateº of a claimed invention. inventor to ®le (FITF) provisions of the AIA as set AIA 35 U.S.C. 102(d) sets forth the criteria to forth in 35 U.S.C. 100 (note). See MPEP § 2159 et determine when subject matter described in a U.S. seq. to determine whether an application is subject patent document was ªeffectively ®ledº for purposes to examination under the FITF provisions, and of AIA 35 U.S.C. 102(a)(2). MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] 2154.01(a) WIPO Published Applications [R-11.2013] AIA 35 U.S.C. 102(d) provides that a U.S. patent, U.S. patent application publication, or WIPO [Editor Note: This MPEP section is only applicable published application (ªU.S. patent documentº) is to applications subject to examination under the ®rst prior art under AIA 35 U.S.C. 102(a)(2) with respect inventor to ®le (FITF) provisions of the AIA as set to any subject matter described in the patent or forth in 35 U.S.C. 100 (note). See MPEP § 2159 et published application as of either its actual ®ling seq. to determine whether an application is subject date (AIA 35 U.S.C. 102(d)(1)), or the ®ling date of to examination under the FITF provisions, and a prior application to which there is a priority or MPEP § 2131-MPEP § 2138 for examination of bene®t claim (AIA 35 U.S.C. 102(d)(2)). A U.S. applications subject to pre-AIA 35 U.S.C. 102.] patent document ªis entitled to claimº priority to, or the bene®t of, a prior-®led application if it ful®lls The WIPO publication of a PCT international the ministerial requirements of: (1) containing a application that designates the United States is an priority or bene®t claim to the prior-®led application; application for patent deemed published under 35 (2) being ®led within the applicable ®ling period U.S.C. 122(b) for purposes of AIA 35 U.S.C. requirement (copending with or within twelve 102(a)(2) under 35 U.S.C. 374. Thus, under the AIA, months of the earlier ®ling, as applicable); and (3) WIPO publications of PCT applications that having a common inventor or being by the same designate the United States are treated as U.S. patent applicant. See MPEP § 211 et. seq. application publications for prior art purposes, regardless of the international ®ling date, whether The AIA draws a distinction between actually being they are published in English, or whether the PCT entitled to priority to, or the bene®t of, a prior-®led international application enters the national stage in application according to the de®nition of ªeffective the United States. Accordingly, a U.S. patent, a U.S. ®ling dateº of a claimed invention in AIA 35 U.S.C. patent application publication, or a WIPO published 100(i)(1)(B), and merely being entitled to claim application that names another inventor and was priority to, or the bene®t of, a prior-®led application effectively ®led before the effective ®ling date of according to the use of ªeffectively ®ledº in AIA 35 the claimed invention, is prior art under AIA 35 U.S.C. 102(d). As a result of this distinction, the

2100-213 Rev. 07.2015, October 2015 § 2154.01(c) MANUAL OF PATENT EXAMINING PROCEDURE

question of whether a patent or published application U.S.C. 102(e) prior art date under pre-AIA law under is actually entitled to priority or bene®t with respect certain circumstances. See MPEP § 706.02(f). to any of its claims is not at issue in determining the date the patent or published application was 2154.01(c) Requirement Of ªNames Another ªeffectively ®ledº for prior art purposes. Thus, as Inventorº [R-11.2013] was the case even prior to the AIA, there is no need to evaluate whether any claim of a U.S. patent [Editor Note: This MPEP section is only applicable document is actually entitled to priority or bene®t to applications subject to examination under the ®rst under 35 U.S.C. 119, 120, 121, or 365 when applying inventor to ®le (FITF) provisions of the AIA as set such a document as prior art. See MPEP § 2136.03, forth in 35 U.S.C. 100 (note). See MPEP § 2159 et subsection IV. seq. to determine whether an application is subject to examination under the FITF provisions, and AIA 35 U.S.C. 102(d) requires that a prior-®led MPEP § 2131-MPEP § 2138 for examination of application to which a priority or bene®t claim is applications subject to pre-AIA 35 U.S.C. 102.] made must describe the subject matter from the U.S. patent document relied upon in a rejection. However, To qualify as prior art under AIA 35 U.S.C. AIA 35 U.S.C. 102(d) does not require that this 102(a)(2), the prior art U.S. patent, U.S. patent description meet the enablement requirements of 35 application publication, or WIPO published U.S.C. 112(a). As discussed previously with respect application (ªU.S. patent documentº) must ªname[ to AIA 35 U.S.C. 102(a)(1), the Of®ce does not view ] another inventor.º This means that if there is any the AIA as changing the extent to which a claimed difference in inventive entity between the prior art invention must be described for a prior art document U.S. patent document and the application under to anticipate the claimed invention under AIA 35 examination or patent under reexamination, the U.S. U.S.C. 102. patent document satis®es the ªnames another inventorº requirement of AIA 35 U.S.C. 102(a)(2). The AIA also eliminates the so-called Hilmer Thus, in the case of joint inventors, only one joint doctrine. Under the Hilmer doctrine, pre-AIA 35 inventor needs to be different for the inventive U.S.C. 102(e) limited the effective ®ling date for entities to be different. Even if there are one or more U.S. patents (and published applications) as prior joint inventors in common in a U.S. patent document art to their earliest U.S. ®ling date. In re Hilmer, and the later-®led application under examination or 359 F.2d 859, 149 USPQ 480 (CCPA 1966). In patent under reexamination, the U.S. patent contrast, AIA 35 U.S.C. 102(d) provides that if the document quali®es as prior art under AIA 35 U.S.C. U.S. patent document claims priority to one or more 102(a)(2) unless an exception in AIA 35 U.S.C. prior-®led foreign or international applications under 102(b)(2) is applicable. 35 U.S.C. 119 or 365, the patent or published application was effectively ®led on the ®ling date 2154.02 Prior Art Exceptions Under 35 of the earliest such application that describes the U.S.C. 102(b)(2) to AIA 35 U.S.C. 102(a)(2) subject matter. Therefore, if the subject matter relied upon is described in the application to which there [R-11.2013] is a priority or bene®t claim, the U.S. patent document is effective as prior art as of the ®ling date [Editor Note: This MPEP section is only applicable of the earliest such application, regardless of where to applications subject to examination under the ®rst ®led. When examining an application to which the inventor to ®le (FITF) provisions of the AIA as set AIA changes in 35 U.S.C. 102 and 103 do not apply, forth in 35 U.S.C. 100 (note). See MPEP § 2159 et Of®ce personnel will continue to apply the Hilmer seq. to determine whether an application is subject doctrine, and foreign priority dates may not be used to examination under the FITF provisions, and in determining pre-AIA 35 U.S.C. 102(e) prior art MPEP § 2131-MPEP § 2138 for examination of dates. Note that the international ®ling date of a applications subject to pre-AIA 35 U.S.C. 102.] published PCT application may be the pre-AIA 35

Rev. 07.2015, October 2015 2100-214 PATENTABILITY § 2154.02(b)

See MPEP § 2154.02(a) for prior art exceptions to matter disclosed directly or indirectly from the 35 U.S.C. 102(a)(2) under AIA 35 U.S.C. inventor or a joint inventor under the exception of 102(b)(2)(A) based on the inventor-originated AIA 35 U.S.C. 102(b)(2)(A) for an disclosure exception. See MPEP § 2154.02(b) for inventor-originated disclosure. prior art exceptions to AIA 35 U.S.C. 102(a)(2) based on inventor or inventor-originated prior public 2154.02(b) Prior Art Exception Under AIA disclosures as provided for in AIA 35 U.S.C. 35 U.S.C. 102(b)(2)(B) to AIA 35 U.S.C. 102(b)(2)(B). See MPEP § 2154.02(c) the prior art 102(a)(2) (Inventor or Inventor-Originated exception under AIA 35 U.S.C. 102(b)(2)(C) to AIA Prior Public Disclosure Exception) 35 U.S.C. 102(a)(2) based on common ownership [R-11.2013] or obligation of assignment. [Editor Note: This MPEP section is only applicable 2154.02(a) Prior Art Exception Under AIA to applications subject to examination under the ®rst 35 U.S.C. 102(b)(2)(A) to AIA 35 U.S.C. inventor to ®le (FITF) provisions of the AIA as set 102(a)(2) (Inventor-Originated Disclosure forth in 35 U.S.C. 100 (note). See MPEP § 2159 et Exception) [R-11.2013] seq. to determine whether an application is subject to examination under the FITF provisions, and [Editor Note: This MPEP section is only applicable MPEP § 2131-MPEP § 2138 for examination of to applications subject to examination under the ®rst applications subject to pre-AIA 35 U.S.C. 102.] inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et AIA 35 U.S.C. 102(b)(2)(B) provides additional seq. to determine whether an application is subject exceptions to the prior art provisions of AIA 35 to examination under the FITF provisions, and U.S.C. 102(a)(2). These exceptions disqualify subject MPEP § 2131-MPEP § 2138 for examination of matter that was effectively ®led by another after the applications subject to pre-AIA 35 U.S.C. 102.] subject matter had been publicly disclosed by the inventor, a joint inventor, or another who obtained AIA 35 U.S.C. 102(b)(2)(A) provides an exception the subject matter directly or indirectly from the to the prior art provisions of AIA 35 U.S.C. inventor or joint inventor. 102(a)(2). This exception limits the use of an inventor©s own work as prior art, when the inventor©s Speci®cally, AIA 35 U.S.C. 102(b)(2)(B) provides own work is disclosed in a U.S. patent, U.S. patent that a disclosure which would otherwise qualify as application publication, or WIPO published prior art under AIA 35 U.S.C. 102(a)(2) (a U.S. application (ªU.S. patent documentº) by another patent, U.S. patent application publication, or WIPO who obtained the subject matter directly or indirectly published application (ªU.S. patent documentº)) from the inventor or joint inventor. may be disquali®ed as prior art if the subject matter disclosed had been previously publicly disclosed by Speci®cally, AIA 35 U.S.C. 102(b)(2)(A) provides the inventor, a joint inventor, or another who that a disclosure which would otherwise qualify as obtained the subject matter directly or indirectly prior art under AIA 35 U.S.C. 102(a)(2) may be from the inventor or joint inventor. The previous disquali®ed as prior art if the subject matter public disclosure of the subject matter by the disclosed was obtained directly or indirectly from inventor, a joint inventor, or another who obtained the inventor or a joint inventor. Thus, if the subject the subject matter directly or indirectly from the matter in a U.S. patent document upon which the inventor or joint inventor must itself be a public rejection is based is by another who obtained the disclosure (i.e., be either an inventor disclosure by subject matter from the inventor or a joint inventor, the inventor or a joint inventor or be an the applicant may establish by way of an af®davit inventor-originated disclosure by another who or declaration that a disclosure is not prior art under obtained the subject matter directly or indirectly AIA 35 U.S.C. 102(a)(2). MPEP § 2155.03 discusses from the inventor or joint inventor). If a previous the use of af®davits or declarations to show that the public disclosure by the inventor or which originated disclosure was by another who obtained the subject

2100-215 Rev. 07.2015, October 2015 § 2154.02(b) MANUAL OF PATENT EXAMINING PROCEDURE

with the inventor is not within the grace period of another who obtained the subject matter directly or AIA 35 U.S.C. 102(b)(1), it would qualify as prior indirectly from the inventor or joint inventor) before art under AIA 35 U.S.C. 102(a)(1), and could not the date the subject matter relied upon was be disquali®ed under AIA 35 U.S.C. 102(b)(1). effectively ®led. The subject matter of an intervening MPEP § 2155.02 discusses the use of af®davits or U.S. patent document that was not previously declarations to show that the subject matter disclosed publicly disclosed by the inventor or a joint inventor had, before such disclosure, been publicly disclosed (or by another who obtained the subject matter from by the inventor or a joint inventor, and MPEP § the inventor or joint inventor) is available as prior 2155.03 discusses the use of af®davits or art under AIA 35 U.S.C. 102(a)(2). For example, if declarations to show that another who obtained the the inventor or a joint inventor had publicly disclosed subject matter disclosed directly or indirectly from elements A, B, and C, and a subsequent intervening the inventor or a joint inventor. U.S. patent document discloses elements A, B, C, and D, then only element D of the intervening U.S. Similar to the previous discussion of AIA 35 U.S.C. patent document is available as prior art under AIA 102(b)(1)(B), the exception in AIA 35 U.S.C. 35 U.S.C. 102(a)(2). 102(b)(2)(B) applies if the ªsubject matter disclosed [in the intervening disclosure] had, before such In addition, if subject matter of an intervening U.S. [intervening] disclosure was effectively ®led under patent document is simply a more general description subsection (a)(2), been publicly disclosed by the of the subject matter previously publicly disclosed inventor or a joint inventor or another who obtained by the inventor or a joint inventor (or another who the subject matter directly or indirectly from the obtained the subject matter directly or indirectly inventor or joint inventor.º The exception in AIA from the inventor or joint inventor), the exception 35 U.S.C. 102(b)(2)(B) focuses on the ªsubject in AIA 35 U.S.C. 102(b)(1)(B) applies to such matterº that had been publicly disclosed by the subject matter of the intervening U.S. patent inventor or a joint inventor (or another who obtained document. For example, if the inventor or a joint the subject matter directly or indirectly from the inventor had publicly disclosed a species, and a inventor or joint inventor). There is no requirement subsequent intervening U.S. patent document under 35 U.S.C. 102(b)(2)(B) that the mode of prior discloses a genus (i.e., provides a more generic disclosure by the inventor or a joint inventor (or disclosure of the species), the disclosure of the genus another who obtained the subject matter directly or in the intervening U.S. patent document is not indirectly from the inventor or joint inventor) be the available as prior art under AIA 35 U.S.C. 102(a)(2). same as the mode of disclosure of the intervening Conversely, if the inventor or a joint inventor had U.S. patent document(e.g., patenting, publication, publicly disclosed a genus, and a subsequent public use, sale activity). There is also no intervening U.S. patent document discloses a species, requirement that the prior disclosure by the inventor the disclosure of the species in the subsequent or a joint inventor be a verbatim or ipsissimis verbis intervening U.S. patent document would be available disclosure of the intervening U.S. patent document. as prior art under AIA 35 U.S.C. 102(a)(2). What is required for subject matter in the intervening Likewise, if the inventor or a joint inventor had U.S. patent document to be excepted under AIA 35 publicly disclosed a species, and a subsequent U.S.C. 102(b)(2)(B) is that the subject matter must intervening U.S. patent document discloses an have been previously publicly disclosed by the alternative species not also disclosed by the inventor inventor or a joint inventor (or another who obtained or a joint inventor, the disclosure of the alternative the subject matter directly or indirectly from the species in the intervening U.S. patent document inventor or joint inventor). would be available as prior art under AIA 35 U.S.C. 102(a)(2). The exception in AIA 35 U.S.C. 102(b)(2)(B) applies only to the subject matter in the intervening U.S. Finally, AIA 35 U.S.C. 102(b)(2)(B) does not discuss patent document being relied upon for a rejection ªthe claimed inventionº with respect to either the under AIA 35 U.S.C. 102(a)(2) that was also publicly subject matter disclosed by the inventor or a joint disclosed by the inventor or a joint inventor (or inventor, or the subject matter of the subsequent

Rev. 07.2015, October 2015 2100-216 PATENTABILITY § 2154.02(c)

intervening U.S. patent document. Any inquiry with U.S.C. 102 or 103. This differs from pre-AIA 35 respect to the claimed invention is whether or not U.S.C. 103(c) in which prior art can preclude the subject matter in the prior art disclosure being patentability under pre-AIA 35 U.S.C. 102, even if relied upon anticipates or renders obvious the the conditions of pre-AIA 35 U.S.C. 103(c) are met. claimed invention. A determination of whether the The consequence of this distinction is that a exception in AIA 35 U.S.C. 102(b)(2)(B) is published application or an issued patent that falls applicable to subject matter in an intervening U.S. under the common ownership exception of AIA 35 patent document does not involve a comparison of U.S.C. 102(b)(2)(C) may not be applied in either an the subject matter of the claimed invention to either anticipation or an obviousness rejection. the subject matter disclosed by the inventor or a joint inventor, or to the subject matter of the subsequent It is important to note the circumstances in which intervening U.S. patent document. the AIA 35 U.S.C. 102(b)(2)(C) exception does not remove a U.S. patent document as a basis for a 2154.02(c) Prior Art Exception Under AIA rejection. The AIA 35 U.S.C. 102(b)(2)(C) exception 35 U.S.C. 102(b)(2)(C) to AIA 35 U.S.C. does not apply to a disclosure that quali®es as prior 102(a)(2) (Common Ownership or Obligation art under AIA 35 U.S.C. 102(a)(1) (disclosures made of Assignment) [R-11.2013] before the effective ®ling date of the claimed invention). Thus, if the issue date of a U.S. patent document is before the effective ®ling date of the [Editor Note: This MPEP section is only applicable claimed invention, it may be prior art under AIA 35 to applications subject to examination under the ®rst U.S.C. 102(a)(1), regardless of common ownership inventor to ®le (FITF) provisions of the AIA as set or the existence of an obligation to assign. Also, forth in 35 U.S.C. 100 (note). See MPEP § 2159 et even if a U.S. patent or U.S. published application seq. to determine whether an application is subject is not prior art under AIA 35 U.S.C. 102 or 103 as to examination under the FITF provisions, and a result of AIA 35 U.S.C. 102(b)(2)(C), a double MPEP § 2131-MPEP § 2138 for examination of patenting rejection (either statutory under 35 U.S.C. applications subject to pre-AIA 35 U.S.C. 102.] 101 or non-statutory, sometimes called obviousness-type) may still be made on the basis of AIA 35 U.S.C. 102(b)(2)(C) provides an additional the U.S. patent or U.S. patent application publication. exception to the prior art provisions of AIA 35 Furthermore, the U.S. patent document that does not U.S.C. 102(a)(2). The exception of AIA 35 U.S.C. qualify as prior art as a result of AIA 35 U.S.C. 102(b)(2)(C) disquali®es subject matter disclosed 102(b)(2)(C) may still be cited, in appropriate in a U.S. patent, U.S. patent application publication, situations, to indicate the state of the art when or WIPO published application (ªU.S. patent making a lack of enablement rejection under 35 documentº) from constituting prior art under AIA U.S.C. 112(a). A document need not qualify as prior 35 U.S.C. 102(a)(2) if the subject matter disclosed art to be applied in the context of double patenting, and the claimed invention, not later than the effective see MPEP § 804.03 (prior art disquali®ed under the ®ling date of the claimed invention, ªwere owned CREATE Act may be the basis for a double by the same person or subject to an obligation of patenting rejection), or enablement. See MPEP § assignment to the same person.º AIA 35 U.S.C. 2124. 102(b)(2)(C) resembles pre-AIA 35 U.S.C. 103(c) in that both concern common ownership, and offer The Of®ce revised the rules of practice to include an avenue by which an applicant may avoid certain provisions that pertain to commonly owned or joint prior art. However, there are signi®cant differences research agreement subject matter (37 CFR between AIA 35 U.S.C. 102(b)(2)(C) and pre-AIA 1.104(c)(4) and (c)(5)). 37 CFR 1.104(c)(4) applies 35 U.S.C. 103(c). to an application that is subject to AIA 35 U.S.C. 102 and 35 U.S.C. 103, and 37 CFR 1.104(c)(5) If the provisions of AIA 35 U.S.C. 102(b)(2)(C) are applies to an application that is subject to pre-AIA met, a U.S. patent document that might otherwise 35 U.S.C. 102 and 103. Commonly owned subject qualify as prior art under AIA 35 U.S.C. 102(a)(2) matter under AIA 35 U.S.C. 102 and 103 is treated is not available as prior art under either AIA 35

2100-217 Rev. 07.2015, October 2015 § 2155 MANUAL OF PATENT EXAMINING PROCEDURE

under 37 CFR 1.104(c)(4)(i), and commonly owned joint inventor, or the subject matter disclosed was obtained subject matter under pre-AIA 35 U.S.C. 102 and 103 directly or indirectly from the inventor or a joint inventor. is treated under 37 CFR 1.104(c)(5)(i). See MPEP (b) Af®davit or declaration of prior public disclosure. § 706.02(l)(1). When any claim of an application or a patent under reexamination is rejected, the applicant or patent owner may submit an appropriate af®davit or declaration to disqualify a A clear and conspicuous statement by the applicant disclosure as prior art by establishing that the subject matter (or the applicant©s representative of record) that the disclosed had, before such disclosure was made or before such claimed invention of the application under subject matter was effectively ®led, been publicly disclosed by examination and the subject matter disclosed in the the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor U.S. patent document applied as prior art were or a joint inventor. An af®davit or declaration under this owned by the same person or subject to an obligation paragraph must identify the subject matter publicly disclosed of assignment to the same person not later than the and provide the date such subject matter was publicly disclosed effective ®ling date of the claimed invention will be by the inventor or a joint inventor or another who obtained the suf®cient to establish that the AIA 35 U.S.C. subject matter disclosed directly or indirectly from the inventor or a joint inventor. 102(b)(2)(C) exception applies. Likewise, when relying on the provisions of pre-AIA 35 U.S.C. (1) If the subject matter publicly disclosed on that date 103(c), the applicant (or the applicant©s was in a printed publication, the af®davit or declaration must representative of record) can provide a similar be accompanied by a copy of the printed publication. statement required to disqualify the cited prior art. (2) If the subject matter publicly disclosed on that date The applicant may present supporting evidence such was not in a printed publication, the af®davit or declaration must describe the subject matter with suf®cient detail and particularity as copies of assignment documents, but is not to determine what subject matter had been publicly disclosed required to do so. Furthermore, the Of®ce will not on that date by the inventor or a joint inventor or another who request corroborating evidence in the absence of obtained the subject matter disclosed directly or indirectly from independent evidence which raises doubt as to the the inventor or a joint inventor. veracity of such a statement. The statement under (c) When this section is not available . The provisions of AIA 35 U.S.C. 102(b)(2)(C) will generally be treated this section are not available if the rejection is based upon a by Of®ce personnel analogously to statements made disclosure made more than one year before the effective ®ling date of the claimed invention. The provisions of this section under pre-AIA 35 U.S.C. 103(c). See MPEP § may not be available if the rejection is based upon a U.S. patent 706.02(l)(2), subsection II. or U.S. patent application publication of a patented or pending application naming another inventor, the patent or pending application claims an invention that is the same or substantially 2155 Use of Af®davits or Declarations Under the same as the applicant©s or patent owner©s claimed invention, 37 CFR 1.130 To Overcome Prior Art and the af®davit or declaration contends that an inventor named Rejections [R-07.2015] in the U.S. patent or U.S. patent application publication derived the claimed invention from the inventor or a joint inventor named in the application or patent, in which case an applicant [Editor Note: This MPEP section is only applicable or a patent owner may ®le a petition for a derivation proceeding to applications subject to examination under the ®rst pursuant to § 42.401 et seq. of this title. inventor to ®le (FITF) provisions of the AIA as set (d) Applications and patents to which this section is forth in 35 U.S.C. 100 (note). See MPEP § 2159 et applicable. The provisions of this section apply to any seq. to determine whether an application is subject application for patent, and to any patent issuing thereon, that to examination under the FITF provisions, and contains, or contained at any time: MPEP § 2131-MPEP § 2138 for examination of (1) A claim to a claimed invention that has an effective applications subject to pre-AIA 35 U.S.C. 102.] ®ling date as de®ned in § 1.109 that is on or after March 16, 2013; or 37 CFR 1.130 Af®davit or declaration of attribution or prior (2) A speci®c reference under 35 U.S.C. 120, 121, public disclosure under the Leahy-Smith America Invents 365(c), or 386(c) to any patent or application that contains, or Act. contained at any time, a claim to a claimed invention that has an effective ®ling date as de®ned in § 1.109 that is on or after (a) Af®davit or declaration of attribution. When any claim March 16, 2013. of an application or a patent under reexamination is rejected, the applicant or patent owner may submit an appropriate af®davit The Of®ce has provided a mechanism in 37 CFR or declaration to disqualify a disclosure as prior art by establishing that the disclosure was made by the inventor or a 1.130 for ®ling an af®davit or declaration to establish

Rev. 07.2015, October 2015 2100-218 PATENTABILITY § 2155.02

that a disclosure is not prior art under AIA 35 U.S.C. acceptable in the absence of evidence to the contrary. 102(a) due to an exception in AIA 35 U.S.C. 102(b). See In re DeBaun, 687 F.2d 459, 463, 214 USPQ Under 37 CFR 1.130(a), an af®davit or declaration 933, 936 (CCPA 1982). However, a mere statement of attribution may be submitted to disqualify a from the inventor or a joint inventor without any disclosure as prior art because it was made by the accompanying reasonable explanation may not be inventor or a joint inventor, or the subject matter suf®cient where there is evidence to the contrary. disclosed was obtained directly or indirectly from See Ex parte Kroger, 219 USPQ 370 (Bd. App. the inventor or a joint inventor. Under 37 CFR 1982) (af®rming rejection notwithstanding 1.130(b), an af®davit or declaration of prior public declarations by the alleged actual inventors as to disclosure may be submitted to disqualify an their inventorship in view of a nonapplicant author intervening disclosure as prior art if the subject submitting a letter declaring the nonapplicant matter disclosed had, before such disclosure was author©s inventorship). This is similar to the current made or before such subject matter was effectively process for disqualifying a publication as not being ®led in a U.S. patent, U.S. patent application by ªothersº discussed in MPEP § 2132.01, except publication, or WIPO published application, been that AIA 35 U.S.C. 102(b)(1)(A) requires only that publicly disclosed by the inventor or a joint inventor the disclosure be by the inventor or a joint inventor. or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint 2155.02 Showing That the Subject Matter inventor. Disclosed Had Been Previously Publicly Disclosed by the Inventor or a Joint Inventor 2155.01 Showing That the Disclosure Was [R-11.2013] Made by the Inventor or a Joint Inventor [R-11.2013] [Editor Note: This MPEP section is only applicable to applications subject to examination under the ®rst [Editor Note: This MPEP section is only applicable inventor to ®le (FITF) provisions of the AIA as set to applications subject to examination under the ®rst forth in 35 U.S.C. 100 (note). See MPEP § 2159 et inventor to ®le (FITF) provisions of the AIA as set seq. to determine whether an application is subject forth in 35 U.S.C. 100 (note). See MPEP § 2159 et to examination under the FITF provisions, and seq. to determine whether an application is subject MPEP § 2131-MPEP § 2138 for examination of to examination under the FITF provisions, and applications subject to pre-AIA 35 U.S.C. 102.] MPEP § 2131-MPEP § 2138 for examination of applications subject to pre-AIA 35 U.S.C. 102.] AIA 35 U.S.C. 102(b)(1)(B) provides that a grace period disclosure shall not be prior art to a claimed AIA 35 U.S.C. 102(b)(1)(A) provides that a grace invention under AIA 35 U.S.C. 102(a)(1) if subject period disclosure shall not be prior art to a claimed matter disclosed had, before such disclosure, been invention under AIA 35 U.S.C. 102(a)(1) if the publicly disclosed by the inventor or a joint inventor. disclosure was made by the inventor or a joint Similarly, AIA 35 U.S.C. 102(b)(2)(B) provides that inventor. An applicant may show that a disclosure a disclosure shall not be prior art to a claimed was made by the inventor or a joint inventor by way invention under AIA 35 U.S.C. 102(a)(2) if the of an af®davit or declaration under 37 CFR 1.130(a) subject matter disclosed had, before such subject (an af®davit or declaration of attribution). See In matter was effectively ®led under AIA 35 U.S.C. re Katz, 687 F.2d 450, 455, 215 USPQ 14, 18 (CCPA 102(a)(2), been publicly disclosed by the inventor 1982) and MPEP § 718. Where the authorship of the or a joint inventor. An applicant may show that the prior art disclosure includes the inventor or a joint subject matter disclosed had been publicly disclosed inventor named in the application, an ªunequivocalº by the inventor or a joint inventor before the statement from the inventor or a joint inventor that disclosure or effective ®ling date of the subject he/she (or some speci®c combination of named matter on which the rejection was based by way of inventors) invented the subject matter of the an af®davit or declaration under 37 CFR 1.130(b) disclosure, accompanied by a reasonable explanation (an af®davit or declaration of prior public of the presence of additional authors, may be disclosure). Speci®cally, the af®davit or declaration

2100-219 Rev. 07.2015, October 2015 § 2155.03 MANUAL OF PATENT EXAMINING PROCEDURE

must identify the subject matter publicly disclosed seq. to determine whether an application is subject and establish the date and content of their earlier to examination under the FITF provisions, and public disclosure. If the earlier public disclosure is MPEP § 2131-MPEP § 2138 for examination of a printed publication, the af®davit or declaration applications subject to pre-AIA 35 U.S.C. 102.] must be accompanied by a copy of the printed publication in accordance with37 CFR 1.130(b)(1). AIA 35 U.S.C. 102(b)(1)(A), 102(b)(1)(B), If the earlier disclosure is not a printed publication, 102(b)(2)(A), and 102(b)(2)(B) each provide similar the af®davit or declaration must describe the earlier treatment for disclosures of subject matter by another disclosure with suf®cient detail and particularity to who obtained the subject matter disclosed directly determine that the earlier disclosure is a public or indirectly from the inventor or a joint inventor. disclosure of the subject matter, as required by 37 Speci®cally, AIA 35 U.S.C. 102(b)(1)(A) provides CFR 1.130(b)(2). that a grace period disclosure shall not be prior art to a claimed invention under AIA 35 U.S.C. The manner of disclosure of subject matter 102(a)(1) if the disclosure was made by another who referenced in an af®davit or declaration under 37 obtained the subject matter disclosed directly or CFR 1.130(b)(2) is not critical. Just as the prior art indirectly from the inventor or a joint inventor, and provision of AIA 35 U.S.C. 102(a)(1) encompasses AIA 35 U.S.C. 102(b)(2)(A) provides that a any disclosure that renders a claimed invention disclosure shall not be prior art to a claimed ªavailable to the public,º any manner of disclosure invention under AIA 35 U.S.C. 102(a)(2) if the may be evidenced in an af®davit or declaration under subject matter disclosed was obtained directly or 37 CFR 1.130(b). That is, when using an af®davit indirectly from the inventor or a joint inventor. or declaration under 37 CFR 1.130(b) to disqualify an intervening disclosure as prior art based on a prior In addition, AIA 35 U.S.C. 102(b)(1)(B) and public disclosure by an inventor or a joint inventor, 102(b)(2)(B) respectively provide that a grace period it is not necessary for the subject matter to have been disclosure under AIA 35 U.S.C. 102(a)(1), and that disclosed in the same manner or using the same a disclosure under AIA 35 U.S.C. 102(a)(2) shall words. For example, the inventor or a joint inventor not be prior art to a claimed invention, if the subject may have publicly disclosed the subject matter in matter disclosed had, before such grace disclosure question via a slide presentation at a scienti®c was made or before such subject matter was meeting, while the intervening disclosure of the effectively ®led according to 35 U.S.C. 102(a)(2), subject matter may have been made in a journal been publicly disclosed by another who obtained the article. This difference in the manner of disclosure subject matter disclosed directly or indirectly from or differences in the words used to describe the the inventor or a joint inventor. An applicant may subject matter will not preclude the inventor from also show that another obtained the subject matter submitting an af®davit or declaration under 37 CFR disclosed directly or indirectly from the inventor or 1.130(b) to disqualify the intervening disclosure a joint inventor in an af®davit or declaration under (e.g., a journal article) as prior art. 37 CFR 1.130(a) or (b). Thus, an applicant may establish a prior public disclosure by another during 2155.03 Showing That the Disclosure was the grace period if the applicant can establish that Made, or That Subject Matter had Been subject matter disclosed originated with the inventor Previously Publicly Disclosed, by Another or a joint inventor and that the subject matter was Who Obtained the Subject Matter Disclosed communicated by the inventor or a joint inventor, Directly or Indirectly From the Inventor or directly or indirectly. Any documentation which provides evidence of the communication of the a Joint Inventor [R-11.2013] subject matter by the inventor or a joint inventor to the entity that made the disclosure of the subject [Editor Note: This MPEP section is only applicable matter directly or indirectly, such as by an assignee to applications subject to examination under the ®rst inventor to ®le (FITF) provisions of the AIA as set forth in 35 U.S.C. 100 (note). See MPEP § 2159 et

Rev. 07.2015, October 2015 2100-220 PATENTABILITY § 2155.06

of the inventor, should accompany the af®davit or showing suf®cient proprietary interest is the declaration. applicant under 35 U.S.C. 118 rather than the inventor, the inventor may sign an af®davit or 2155.04 Enablement [R-11.2013] declaration under 37 CFR 1.130 to disqualify a disclosure of the invention as prior art, but the [Editor Note: This MPEP section is only applicable declaration must be ®led by a party having authority to applications subject to examination under the ®rst to take action in the application. Authority to ®le inventor to ®le (FITF) provisions of the AIA as set papers in an application generally does not lie with forth in 35 U.S.C. 100 (note). See MPEP § 2159 et the inventor if the inventor is not the applicant. seq. to determine whether an application is subject to examination under the FITF provisions, and 2155.06 Situations in Which an Af®davit or MPEP § 2131-MPEP § 2138 for examination of Declaration Is Not Available [R-11.2013] applications subject to pre-AIA 35 U.S.C. 102.] [Editor Note: This MPEP section is only applicable An af®davit or declaration under 37 CFR 1.130(a) to applications subject to examination under the ®rst or (b) need not demonstrate that the disclosure by inventor to ®le (FITF) provisions of the AIA as set the inventor, a joint inventor, or another who forth in 35 U.S.C. 100 (note). See MPEP § 2159 et obtained the subject matter disclosed directly or seq. to determine whether an application is subject indirectly from an inventor or a joint inventor was to examination under the FITF provisions, and an ªenablingº disclosure of the subject matter within MPEP § 2131-MPEP § 2138 for examination of the meaning of 35 U.S.C. 112(a). Rather, an af®davit applications subject to pre-AIA 35 U.S.C. 102.] or declaration under 37 CFR 1.130 must show that: (1) the disclosure in question was made by the The provisions of 37 CFR 1.130 are not available if inventor or a joint inventor, or the subject matter the rejection is based upon a disclosure made more disclosed was obtained directly or indirectly from than one year before the effective ®ling date of the the inventor or a joint inventor (37 CFR 1.130(a)); claimed invention. A disclosure made more than one or (2) the subject matter disclosed had, before such year before the effective ®ling date of a claimed disclosure was made or before such subject matter invention is prior art under AIA 35 U.S.C. 102(a)(1) was effectively ®led, been publicly disclosed by the that cannot be disquali®ed under AIA 35 U.S.C. inventor or a joint inventor or another who obtained 102(b)(1). the subject matter disclosed directly or indirectly from the inventor or a joint inventor (37 CFR Additionally, the provisions of 37 CFR 1.130 may 1.130(b)). not be available if the rejection is based upon a U.S. patent or U.S. patent application publication naming 2155.05 Who May File an Af®davit or another inventor if: (1) the patent or pending Declaration Under 37 CFR 1.130 [R-11.2013] application claims an invention that is the same or substantially the same as the applicant©s or patent [Editor Note: This MPEP section is only applicable owner©s claimed invention; and (2) the af®davit or to applications subject to examination under the ®rst declaration contends that an inventor named in the inventor to ®le (FITF) provisions of the AIA as set U.S. patent or U.S. patent application publication forth in 35 U.S.C. 100 (note). See MPEP § 2159 et derived the claimed invention from the inventor or seq. to determine whether an application is subject a joint inventor named in the application or patent. to examination under the FITF provisions, and The provisions of 37 CFR 1.130 are not available if MPEP § 2131-MPEP § 2138 for examination of it would result in the Of®ce issuing or con®rming applications subject to pre-AIA 35 U.S.C. 102.] two patents containing patentably indistinct claims to two different parties. See In re Deckler, 977 F.2d In accordance with 37 CFR 1.130, the applicant or 1449, 1451-52, 24 USPQ2d 1448, 1449 (Fed. Cir. patent owner may submit an af®davit or declaration. 1992) (35 U.S.C. 102 , 103, and 135 ªclearly When an assignee, obligated assignee, or person contemplateÐwhere different inventive entities are concernedÐonly one patent should issue for

2100-221 Rev. 07.2015, October 2015 § 2156 MANUAL OF PATENT EXAMINING PROCEDURE

inventions which are either identical to or not AIA de®nes the term ªjoint research agreementº as patentably distinct from each otherº) (quoting Aelony a written contract, grant, or cooperative agreement v. Arni, 547 F.2d 566, 570, 192 USPQ 486, 490 entered into by two or more persons or entities for (CCPA 1977)). In this situation, an applicant or the performance of experimental, developmental, or patent owner may ®le a petition for a derivation research work in the ®eld of the claimed invention. proceeding pursuant to 37 CFR 42.401 et seq. (37 See 35 U.S.C. 100(h). Second, the claimed invention CFR 1.130(c)). must have been made as a result of activities undertaken within the scope of the joint research 2156 Joint Research Agreements [R-11.2013] agreement. See 35 U.S.C. 102(c)(2). Third, the application for patent for the claimed invention must [Editor Note: This MPEP section is only applicable disclose, or be amended to disclose, the names of to applications subject to examination under the ®rst the parties to the joint research agreement. See 35 inventor to ®le (FITF) provisions of the AIA as set U.S.C. 102(c)(3). Joint research agreement subject forth in 35 U.S.C. 100 (note). See MPEP § 2159 et matter under AIA 35 U.S.C. 102 and 103 is treated seq. to determine whether an application is subject under 37 CFR 1.104(c)(5)(ii), joint research to examination under the FITF provisions, and agreement subject matter under pre-AIA 35 U.S.C. MPEP § 2131-MPEP § 2138 and MPEP § 2146 for 102 and 103 is treated under 37 CFR 1.104(c)(5)(ii). examination of applications subject to pre-AIA 35 If these conditions are met, the joint research U.S.C. 102 and 35 U.S.C. 103.] agreement prior art is not available as prior art under AIA 35 U.S.C. 102(a)(2). 35 U.S.C. 102(c) Conditions for patentability; novelty. The provisions of AIA 35 U.S.C. 102(c) generally (c) COMMON OWNERSHIP UNDER JOINT RESEARCH track those of the Cooperative Research and AGREEMENTS.ÐSubject matter disclosed and a claimed Technology Enhancement Act of 2004 (CREATE invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same Act). See MPEP § 706.02(l)(1). The major person in applying the provisions of subsection (b)(2)(C) ifÐ differences between AIA 35 U.S.C. 102(c) and the CREATE Act are that: (1) the AIA provision is (1) the subject matter disclosed was developed and the keyed to the effective ®ling date of the claimed claimed invention was made by, or on behalf of, 1 or more parties to a joint research agreement that was in effect on or invention, while the CREATE Act focuses on the before the effective ®ling date of the claimed invention; date that the claimed invention was made; and (2) (2) the claimed invention was made as a result of the CREATE Act provisions only apply to activities undertaken within the scope of the joint research obviousness rejections and not to anticipation agreement; and rejections. (3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to In order to invoke a joint research agreement to the joint research agreement. disqualify a disclosure as prior art, the applicant (or AIA 35 U.S.C. 102(c) provides three conditions that the applicant©s representative of record) must provide must be satis®ed in order for subject matter disclosed a statement that the disclosure of the subject matter which might otherwise qualify as prior art, and a on which the rejection is based and the claimed claimed invention, to be treated as having been invention were made by or on behalf of parties to a owned by the same person or subject to an obligation joint research agreement under AIA 35 U.S.C. of assignment to the same person in applying 102(c). The statement must also assert that the common ownership provisions of AIA 35 U.S.C. agreement was in effect on or before the effective 102(b)(2)(C) in the context of a joint research ®ling date of the claimed invention, and that the agreement. First, the subject matter disclosed must claimed invention was made as a result of activities have been developed and the claimed invention must undertaken within the scope of the joint research have been made by, or on behalf of, one or more agreement. When relying on the provisions of parties to a joint research agreement that was in pre-AIA 35 U.S.C. 103(c), the applicant or his effect on or before the effective ®ling date of the attorney or agent of record can provide a similar claimed invention. See 35 U.S.C. 102(c)(1). The statement to disqualify the cited prior art as to the

Rev. 07.2015, October 2015 2100-222 PATENTABILITY § 2158

issue of obviousness. If the names of the parties to personnel should reject the claims under 35 U.S.C. the joint research agreement are not already stated 101 and 35 U.S.C. 115. See MPEP § 706.03(a), in the application, it is necessary to amend the subsection IV. Note that a rejection under pre-AIA application to include the names of the parties to the 35 U.S.C. 102(f) should not be made if the joint research agreement in accordance with 37 CFR application is subject to examination under the ®rst 1.71(g). inventor to ®le (FITF) provisions of the AIA. See MPEP § 2159 et seq. to determine whether an As is the case with establishing common ownership, application is subject to examination under the FITF the applicant may, but is not required to, present provisions, and MPEP § 2137 for information evidence supporting the existence of the joint pertaining to pre-AIA 35 U.S.C. 102(f). research agreement. Furthermore, the Of®ce will not request corroborating evidence in the absence 2158 AIA 35 U.S.C. 103 [R-07.2015] of independent evidence which raises doubt as to the existence of the joint research agreement. [Editor Note: This MPEP section is only applicable to applications subject to examination under the ®rst As discussed previously, the AIA 35 U.S.C. inventor to ®le (FITF) provisions of the AIA as set 102(b)(2)(C) exception does not apply to a disclosure forth in 35 U.S.C. 100 (note). See MPEP § 2159 et that quali®es as prior art under AIA 35 U.S.C. seq. to determine whether an application is subject 102(a)(1) (disclosures made before the effective to examination under the FITF provisions, and ®ling date of the claimed invention). Thus, if the MPEP § 2141-MPEP § 2146 for information on issue date or publication date of a U.S. patent pre-AIA 35 U.S.C. 103 and AIA 35 U.S.C. 103.] document is before the effective ®ling date of the claimed invention, it may be prior art under AIA 35 AIA 35 U.S.C. 103 continues to set forth the U.S.C. 102(a)(1), regardless of the fact that the nonobviousness requirement for patentability. There claimed invention resulted from a joint research are, however, some important changes from pre-AIA agreement and the disclosure was by a party to the 35 U.S.C. 103. agreement. The most signi®cant difference between the AIA 35 2157 Improper Naming of Inventors U.S.C. 103 and pre-AIA 35 U.S.C. 103(a) is that [R-07.2015] AIA 35 U.S.C. 103 determines obviousness as of the effective ®ling date of the claimed invention, Although the AIA eliminated pre-AIA 35 U.S.C. rather than as of the time that the claimed invention 102(f), the patent laws still require the naming of was made. Under pre-AIA examination practice, the the actual inventor or joint inventors of the claimed Of®ce uses the effective ®ling date as a proxy for subject matter. See 35 U.S.C. 115(a) (ª[a]n the invention date, unless there is evidence of record application for patent that is ®led under [35 U.S.C.] to establish an earlier date of invention. Thus, as a 111(a) or commences the national stage under [35 practical matter during examination, this distinction U.S.C.] 371 shall include, or be amended to include, between the AIA 35 U.S.C. 103 and pre-AIA 35 the name of the inventor for any invention claimed U.S.C. 103 will result in a difference in practice only in the applicationº). The Of®ce presumes that the when the case under examination is subject to named inventor or joint inventors in the application pre-AIA 35 U.S.C. 103 , and there is evidence in the are the actual inventor or joint inventors to be named case concerning a date of invention prior to the on the patent. See MPEP § 2137.01. Where an effective ®ling date. Such evidence is ordinarily application names an incorrect inventorship, the presented by way of an af®davit or declaration under applicant should submit a request to correct 37 CFR 1.131. inventorship under 37 CFR 1.48. See MPEP § 602.01(c) et seq. In the rare situation where it clear Next, AIA 35 U.S.C. 103 differs from that of that the application does not name the correct pre-AIA 35 U.S.C. 103 in that AIA 35 U.S.C. 103 inventorship and the applicant has not ®led a request requires consideration of ªthe differences between to correct inventorship under 37 CFR 1.48, Of®ce the claimed invention and the prior art,º while

2100-223 Rev. 07.2015, October 2015 § 2158 MANUAL OF PATENT EXAMINING PROCEDURE

pre-AIA 35 U.S.C. 103 refers to ªthe differences commonly owned with the claimed invention, or if between the subject matter sought to be patented and the subject matter was subject to an obligation of the prior art.º This difference in terminology does assignment to the same person, at the time the not indicate the need for any difference in approach claimed invention was made, then pre-AIA 35 U.S.C. to the question of obviousness. As pointed out by 103(a) did not preclude patentability. Furthermore, the Federal Circuit, ª[t]he term `claims© has been under pre-AIA 35 U.S.C. 103(c), if a joint research used in patent legislation since the Patent Act of agreement was in place on or before the date that 1836 to de®ne the invention that an applicant the claimed invention was made, the claimed believes is patentable.º Hoechst-Roussel Pharms., invention was made as a result of activities Inc. v. Lehman, 109 F.3d 756, 758, 42 USPQ2d undertaken within the scope of the joint research 1220, 1222 (Fed. Cir. 1997) (citing Act of July 4, agreement, and the application for patent disclosed 1836, ch. 357, § 6, 5 Stat. 117). Furthermore, in or was amended to disclose the names of the parties Graham v. John Deere, the second of the Supreme to the joint research agreement, common ownership Court©s factual inquiries (the ªGraham factorsº) is or an obligation to assign was deemed to exist. As that the ªdifferences between the prior art and the discussed previously, AIA 35 U.S.C. 102(b)(2)(C) claims at issue are to be ascertained.º 383 U.S. 1, and 102(c) expand on this concept. Under the AIA, 17, 148 USPQ 459, 467. Thus, in interpreting 35 the common ownership, obligation to assign, or joint U.S.C. 103 as enacted in the 1952 Patent research agreement must exist on or before the ActÐlanguage that remained unchanged until effective ®ling date of the claimed invention, rather enactment of the AIAÐthe Court equated ªthe than on or before the date the invention was made. subject matter sought to be patentedº with the claims. If the provisions of AIA 35 U.S.C. 102(b)(2)(C) are met, a disclosure is not prior art at all, whereas under Further, AIA 35 U.S.C. 103 does not contain any pre-AIA 35 U.S.C. 103(c) , certain prior art merely provision similar to pre-AIA 35 U.S.C. 103(b). was de®ned as not precluding patentability. Finally, Pre-AIA 35 U.S.C. 103(b) is narrowly drawn, disclosures disquali®ed as prior art under AIA 35 applying only to nonobviousness of biotechnological U.S.C. 102(b)(2)(C) and 102(c) may not be applied inventions, and even then, only when speci®cally in either an anticipation or an obviousness rejection. invoked by the patent applicant. Pre-AIA 35 U.S.C. However, such disclosures could be the basis for 103(b) provides that under certain conditions, ªa statutory double patenting or non-statutory biotechnological process using or resulting in a (sometimes referred to as obviousness-type) double composition of matter that is novel under section patenting rejections. 102 and nonobvious under subsection [103(a)] of this section shall be considered nonobvious.º In view Generally speaking, and with the exceptions noted of the case law since 1995, the need to invoke herein, pre-AIA notions of obviousness will continue pre-AIA 35 U.S.C. 103(b) has been rare. As stated to apply under the AIA. AIA 35 U.S.C. 102(a) in MPEP § 706.02(n), in view of the Federal Circuit©s de®nes what is prior art both for purposes of novelty decisions in In re Ochiai, 71 F.3d 1565, 37 USPQ2d under AIA 35 U.S.C. 102 as well as for purposes of 1127 (Fed. Cir. 1995) and In re Brouwer, 77 F.3d obviousness under AIA 35 U.S.C. 103. See Hazeltine 422, 37 USPQ2d 1663 (Fed. Cir. 1996), the need to Res., Inc. v. Brenner, 382 U.S. 252, 256, 147 USPQ invoke pre-AIA 35 U.S.C. 103(b) rarely arose. Those 429, 430 (1965) (a previously ®led patent application cases continue to retain their validity under the AIA. to another pending in the Of®ce, but not patented or published, at the time an application is ®led Finally, AIA 35 U.S.C. 103 eliminates pre-AIA 35 constitutes part of the ªprior artº within the meaning U.S.C. 103(c), but corresponding provisions have of 35 U.S.C. 103). Thus, if a document quali®es as been introduced in AIA 35 U.S.C. 102(b)(2)(C) and prior art under AIA 35 U.S.C. 102(a)(1) or (a)(2), 102(c). Pre-AIA 35 U.S.C. 103(c) applied if subject and is not subject to an exception under AIA 35 matter quali®ed as prior art only under pre-AIA 35 U.S.C. 102(b), it may be applied for what it describes U.S.C. 102(e), (f), and/or (g), and only in the context or teaches to those skilled in the art in a rejection of obviousness under pre-AIA 35 U.S.C. 103(a). If under AIA 35 U.S.C. 103. This is in accordance with subject matter developed by another person was pre-AIA case law indicating that in making

Rev. 07.2015, October 2015 2100-224 PATENTABILITY § 2159.02

determinations under 35 U.S.C. 103, ªit must be ®led on or after March 16, 2013, in an application known whether a patent or publication is in the prior that was ®led before March 16, 2013, the application art under 35 U.S.C. 102.º Panduit Corp. v. Dennison remains subject to pre-AIA 35 U.S.C. 102 and 103. Mfg. Co., 810 F.2d 1561, 1568, 1 USPQ2d 1593, Similarly, a PCT application ®led under 35 U.S.C. 1597 (Fed. Cir. 1987). However, while a disclosure 363 before March 16, 2013, is subject to pre-AIA must enable those skilled in the art to make the 35 U.S.C. 102 and 103, regardless of whether the invention in order to anticipate under 35 U.S.C. 102, application enters the national stage under 35 U.S.C. a non-enabling disclosure is prior art for all it teaches 371 before or after March 16, 2013. Additionally, for purposes of determining obviousness under 35 adding claims after March 16, 2013 in an application U.S.C. 103 . Symbol Techs. Inc. v. Opticon Inc., 935 ®led before March 16, 2013 via an amendment F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. which contains new matter does not make the 1991); Beckman Instruments v. LKB Produkter AB, changes to 35 U.S.C. 102 and 35 U.S.C. 103 in the 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. AIA applicable to the application because 35 U.S.C. Cir. 1989) (ªEven if a reference discloses an 132(a) prohibits the introduction of new matter into inoperative device, it is prior art for all that it the disclosure. If new matter is added via teaches.º). Of®ce personnel should continue to amendment, claims directed to the new matter will follow guidance for formulating an appropriate be rejected under pre-AIA 35 U.S.C. 112, ®rst rationale to support any conclusion of obviousness. paragraph. See MPEP § 608.04. See MPEP § 2141 et seq. and the guidance documents available at www.uspto.gov/ 2159.02 Applications Filed on or After patent/laws-and-regulations/examination-policy/examination- March 16, 2013 [R-11.2013] guidelines-training-materials-view-ksr . AIA 35 U.S.C. 102 and 103 took effect on March 2159 Applicability Date Provisions and 16, 2013. AIA 35 U.S.C. 102 and 103 apply to any Determining Whether an Application Is patent application that contains or contained at any Subject to the First Inventor To File time a claim to a claimed invention that has an Provisions of the AIA [R-11.2013] effective ®ling date that is on or after March 16, 2013. If a patent application (1) contains or contained Because the changes to 35 U.S.C. 102 and 35 U.S.C. at any time a claim to a claimed invention having 103 in the AIA apply only to speci®c applications an effective ®ling date as de®ned in 35 U.S.C. 100(i) ®led on or after March 16, 2013, determining the that is on or after March 16, 2013 or (2) claims or effective ®ling date of a claimed invention for ever claimed the bene®t of an earlier ®ling date purposes of applying AIA 35 U.S.C. 102 and 103 under 35 U.S.C. 120 , 121, or 365 based upon an provisions or pre-AIA 35 U.S.C. 102 and 103 earlier application that ever contained such a claim, provisions is critical. then AIA 35 U.S.C. 102 and 103 apply to the application, (i.e., the application is an AIA 2159.01 Applications Filed Before March 16, application). If there is ever even a single claim to 2013 [R-11.2013] a claimed invention in the application having an effective ®ling date on or after March 16, 2013, AIA 35 U.S.C. 102 and 103 apply in determining the The changes to 35 U.S.C. 102 and 103 in the AIA patentability of every claimed invention in the do not apply to any application ®led before March application. This is the situation even if the 16, 2013. Thus, any application ®led before March remaining claimed inventions all have an effective 16, 2013, is governed by pre-AIA 35 U.S.C. 102 and ®ling date before March 16, 2013, and even if the 103 (i.e., the application is a pre-AIA ®rst to invent claim to a claimed invention having an effective application). Note that neither the ®ling of a request ®ling date on or after March 16, 2013, is canceled. for continued examination, nor entry into the national stage under 35 U.S.C. 371, constitutes the ®ling of If an application ®led on or after March 16, 2013, a new application. Accordingly, even if a request that did not previously contain any claim to a for continued examination under 37 CFR 1.114 is claimed invention having an effective ®ling date on

2100-225 Rev. 07.2015, October 2015 § 2159.03 MANUAL OF PATENT EXAMINING PROCEDURE

or after March 16, 2013, (a pre-AIA application) is would actually introduce new matter into the amended to contain a claim to a claimed invention disclosure of the invention. Therefore, an amendment having an effective ®ling date on or after March 16, (other than a preliminary amendment ®led on the 2013, the application becomes an AIA application same day as such application) seeking to add a claim (AIA 35 U.S.C. 102 and 103 apply to the to a claimed invention that is directed to new matter application), provided that the newly added claimed in an application ®led on or after March 16, 2013, invention has support under 35 U.S.C. 112(a) in the that, as originally ®led, discloses and claims only application ®led on or after March 16, 2013. The subject matter also disclosed in an earlier application application also becomes subject to AIA 35 U.S.C. ®led before March 16, 2013 to which the application 102 and 103 even if the claim to a claimed invention ®led on or after March 16, 2013, is entitled to having an effective ®ling date on or after March 16, priority or bene®t under 35 U.S.C. 119, 120, 121, 2013, is subsequently canceled. If an amendment or 365, would not change the application from a after an Of®ce action causes the application to pre-AIA application into an AIA application. change from being governed by pre-AIA 35 U.S.C. 102 and 103 (from being a pre-AIA application) to 2159.03 Applications Subject to the AIA but being governed by AIA 35 U.S.C. 102 and 103 (to Also Containing a Claimed Invention Having being a AIA application), any new ground of an Effective Filing Date Before March 16, rejection necessitated by the change in applicable 2013 [R-11.2013] law would be considered a new ground of rejection necessitated by an amendment for purposes of Even if AIA 35 U.S.C. 102 and 103 apply to a patent determining whether the next Of®ce action may be application, pre-AIA 35 U.S.C. 102(g) also applies made ®nal. See MPEP § 706.07(a). to every claim in the application if it: (1) contains or contained at any time a claimed invention having As 35 U.S.C. 132(a) prohibits the introduction of an effective ®ling date as de®ned in 35 U.S.C. 100(i) new matter into the disclosure, an application may that occurs before March 16, 2013; or (2) is ever not contain a claim to a claimed invention that does designated as a continuation, divisional, or not have support under 35 U.S.C. 112(a) in the continuation-in-part of an application that contains application (that is directed to new matter). Thus, or contained at any time such a claim. Pre-AIA 35 an application cannot ªcontainº a claim to a claimed U.S.C. 102(g) also applies to any patent resulting invention that is directed to new matter for purposes from an application to which pre-AIA 35 U.S.C. of determining whether the application ever 102(g) applied. See MPEP § 2138. contained a claim to a claimed invention having an effective ®ling date on or after March 16, 2013. Thus, if an application contains, or contained at any Amendments that are believed to contain new matter time, any claim having an effective ®ling date that should be treated as follows: (1) a new drawing occurs before March 16, 2013, and also contains, or should not be entered if the examiner discovers that contained at any time, any claim having an effective the drawing contains new matter (MPEP § 608.02, ®ling date that is on or after March 16, 2013, each subsection II.); and (2) amendments to the written claim must be patentable under AIA 35 U.S.C. 102 description or claims involving new matter are and 103, as well as pre-AIA 35 U.S.C. 102(g), for ordinarily entered, but the new matter is required to the applicant to be entitled to a patent. However, an be canceled from the written description and the application will not otherwise be concurrently claims directed to the new matter are rejected under subject to both pre-AIA 35 U.S.C. 102 and 103 and 35 U.S.C. 112(a) (MPEP § 608.04). This process for AIA 35 U.S.C. 102 and 103. treating amendments containing new matter is purely an administrative process for handling an amendment seeking to introduce new matter into the disclosure For these reasons, when subject matter is claimed of the invention in violation of 35 U.S.C. 132(a), in an application ®led on or after March 16, 2013 and for resolving disputes between the applicant and having priority to or the bene®t (e.g., under 35 an examiner as to whether a new drawing or U.S.C. 120, 121, or 365(c)) of a prior application amendment to the written description or claims ®led before March 16, 2013, care must be taken to accurately determine whether AIA or pre-AIA 35

Rev. 07.2015, October 2015 2100-226 PATENTABILITY § 2161

U.S.C. 102 and 103 applies to the application. See terms as to enable any person skilled in the art Also MPEP § 2151. to which it pertains, or with which it is most nearly connected, to make and use the same, 2159.04 Applicant Statement in Transition and shall set forth the best mode contemplated Applications Containing a Claimed Invention by the inventor or joint inventor of carrying out Having an Effective Filing Date on or After the invention. March 16, 2013 [R-11.2013] The ®rst paragraph of pre-AIA 35 U.S.C. 112 The Of®ce revised 37 CFR 1.55 and 1.78 to require (applicable to applications ®led before September that if a nonprovisional application ®led on or after 16, 2012) provides: March 16, 2013, claims the bene®t of or priority to an application where the ®ling date of a foreign, U.S. The speci®cation shall contain a written provisional, U.S. nonprovisional, or international description of the invention, and of the manner application is prior to March 16, 2013 (termed as ªa and process of making and using it, in such full, transition applicationº), and also contains or clear, concise, and exact terms as to enable any contained at any time a claimed invention having an person skilled in the art to which it pertains, or effective ®ling date on or after March 16, 2013, the with which it is most nearly connected, to make applicant must provide a statement to that effect and use the same, and shall set forth the best (ªthe 37 CFR 1.55 or 1.78 statementº). This mode contemplated by the inventor of carrying information will assist the Of®ce in determining out his invention. [emphasis added]. whether the transition application is subject to AIA 35 U.S.C. 102 and 103 or pre-AIA 35 U.S.C. 102 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, ®rst and 103. However, applicant is not required to paragraph require that the speci®cation include the provide this information if the transition application following: claims the bene®t of an earlier transition application in which a 37 CFR 1.55 or 37 CFR 1.78 statement (A) A written description of the invention; has been ®led. See 37 CFR 1.78(c)(6)(i). See also MPEP § 210. (B) The manner and process of making and using the invention (the enablement requirement); and 2160 [Reserved] (C) The best mode contemplated by the inventor of carrying out his invention. II. THE THREE REQUIREMENTS ARE 2161 Three Separate Requirements for SEPARATE AND DISTINCT FROM EACH OTHER Speci®cation Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph The written description requirement is separate and [R-07.2015] distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, I. THE SPECIFICATION MUST INCLUDE A 1341, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en WRITTEN DESCRIPTION OF THE INVENTION, banc) (If Congress had intended enablement to be ENABLEMENT, AND BEST MODE OF CARRYING the sole description requirement of § 112, ®rst OUT THE CLAIMED INVENTION paragraph, the statute would have been written differently.) Vas-Cath, Inc. v. Mahurkar, 935 F.2d 35 U.S.C. 112(a) (applicable to applications ®led on or 1555, 1562, 19 USPQ2d 1111, 1115 (Fed. Cir. 1991) after September 16, 2012) provides: (While acknowledging that some of its cases concerning the written description requirement and (a) IN GENERAL.ÐThe speci®cation shall the enablement requirement are confusing, the contain a written description of the invention, Federal Circuit reaf®rmed that under 35 U.S.C. 112, and of the manner and process of making and ®rst paragraph, the written description requirement using it, in such full, clear, concise, and exact is separate and distinct from the enablement

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requirement and gave an example thereof.); In re three separate and distinct requirements of 35 U.S.C. Barker, 559 F.2d 588, 194 USPQ 470 (CCPA 1977), 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. cert. denied, 434 U.S. 1064 (1978). See also, e.g., In addition, claims with computer-implemented Vasudevan Software, Inc. v. MicroStrategy, Inc., functional claim limitations may invoke 35 U.S.C. 782 F.3d 671, 682-683, 684, 114 USPQ2d 1349, 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 1356, 1357 (Fed. Cir. 2015) (reversing the district See MPEP § 2181, subsection II.B. and § 2181, court©s grants of summary judgment because there subsection IV. for information regarding means- (or were genuine issues of material fact regarding 1) step-) plus- function limitations. whether the claims were enabled (ªthe effort it took the inventor to reduce the invention to practice does I. DETERMINING WHETHER THERE IS not conclusively show lack of enablementº) and 2) ADEQUATE WRITTEN DESCRIPTION FOR A whether the claims had suf®cient written description COMPUTER-IMPLEMENTED FUNCTIONAL support (ª[t]he fact that . . . the speci®cation do[es] CLAIM LIMITATION not speak in haec verba of accessing `disparate databases' does not eliminate as a genuine issue of The 35 U.S.C. 112(a) or ®rst paragraph of pre-AIA material fact that the existence of at least some 35 U.S.C. 112 contains a written description discussion, and therefore, possession, of the requirement that is separate and distinct from the accessing of disparate databases, as claimedº). An enablement requirement. Ariad Pharm., Inc. v. Eli invention may be described without the disclosure Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, being enabling (e.g., a chemical compound for which 1167 (Fed. Cir. 2010) (en banc). To satisfy the there is no disclosed or apparent method of making), written description requirement, the speci®cation and a disclosure could be enabling without must describe the claimed invention in suf®cient describing the invention (e.g., a speci®cation detail that one skilled in the art can reasonably describing a method of making and using a paint conclude that the inventor had possession of the composition made of functionally de®ned ingredients claimed invention. LizardTech, Inc. v. Earth Res. within broad ranges would be enabling for Mapping, Inc., 424 F.3d 1336, 1344-45, 76 USPQ2d formulations falling within the description but would 1724, 1731-32 (Fed. Cir. 2005); Vas-Cath, Inc. v. not describe any speci®c formulation). See In Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d re Armbruster, 512 F.2d 676, 677, 185 USPQ 152, 1111, 1115-16 (Fed. Cir. 1991). Speci®cally, the 153 (CCPA 1975) (ª[A] speci®cation which speci®cation must describe the claimed invention in `describes' does not necessarily also `enable' one a manner understandable to a person of ordinary skilled in the art to make or use the claimed skill in the art and show that the inventor actually invention.º). Best mode is a separate and distinct invented the claimed invention. Id.; Ariad, 598 F.3d requirement from the enablement requirement. In at 1351, 94 USPQ2d at 1172. The function of the re Newton, 414 F.2d 1400, 163 USPQ 34 (CCPA written description requirement is to ensure that the 1969). inventor had possession of, as of the ®ling date of the application relied on, the speci®c subject matter 2161.01 Computer Programming and 35 later claimed by him or her; how the speci®cation U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First accomplishes this is not material. In re Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA Paragraph [R-07.2015] 1979) and further reiterated in In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983). See The statutory requirements for also MPEP § 2163 - § 2163.04. computer-implemented inventions are the same as for all inventions, such as the subject matter The written description requirement of 35 U.S.C. eligibility and utility requirements under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, 101 (see MPEP §§ 2106 and 2107, respectively), the applies to all claims including original claims that novelty requirement of 35 U.S.C. 102, the are part of the disclosure as ®led. Ariad, 598 F.3d nonobviousness requirement of 35 U.S.C. 103, the at 1349, 94 USPQ2d at 1170. As stated by the de®niteness requirement of 35 U.S.C. 112(b) or Federal Circuit, ª[a]lthough many original claims pre-AIA 35 U.S.C. 112, second paragraph, and the

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will satisfy the written description requirement, no evidence that the speci®cation contemplated a certain claims may not.º Id. at 1349, 94 USPQ2d more generic way of creating a seamless array of at 1170-71; see also LizardTech, Inc. v. Earth Res. DWT coef®cients. Therefore, the written description Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d requirement was not satis®ed in this case because 1724, 1730-33 (Fed. Cir. 2005); Regents of the Univ. the speci®cation did not provide suf®cient evidence of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 that the inventor invented the generic claim. ª[T]he USPQ2d 1398, 1405-06 (Fed. Cir. 1997). Problems description of one method for creating a seamless satisfying the written description requirement for DWT does not entitle the inventor . . . to claim any original claims often occur when claim language is and all means for achieving that objective.º generic or functional, or both. Ariad, 593 F.3d at LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733. 1349, 94 USPQ2d at 1171 ("The problem is especially acute with genus claims that use functional Similarly, original claims may fail to satisfy the language to de®ne the boundaries of a claimed written description requirement when the invention genus. In such a case, the functional claim may is claimed and described in functional language simply claim a desired result, and may do so without (whether or not the functional claim language describing species that achieve that result. But the invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, speci®cation must demonstrate that the applicant sixth paragraph) but the speci®cation does not has made a generic invention that achieves the suf®ciently identify how the invention achieves the claimed result and do so by showing that the claimed function. applicant has invented species suf®cient to support a claim to the functionally-de®ned genus."). The level of detail required to satisfy the written description requirement varies depending on the For instance, generic claim language in the original nature and scope of the claims and on the complexity disclosure does not satisfy the written description and predictability of the relevant technology. Ariad, requirement if it fails to support the scope of the 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. genus claimed. Ariad, 598 F.3d at 1349-50, 94 Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, USPQ2d at 1171 (ª[A]n adequate written description 1083-84 (Fed. Cir. 2005). Computer-implemented of a claimed genus requires more than a generic inventions are often disclosed and claimed in terms statement of an invention's boundaries.º) (citing Eli of their functionality. This is because writing Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); computer programming code for software to perform Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d speci®c functions is normally within the skill of the 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) art once those functions have been adequately (holding that generic claim language appearing in disclosed. Fonar Corp. v. General Elec. Co., 107 ipsis verbis in the original speci®cation did not F.3d 1543, 1549, 41 USPQ2d 1801, 1805 (Fed. Cir. satisfy the written description requirement because 1997). Nevertheless, for computer-implemented it failed to support the scope of the genus claimed); inventions, the determination of the suf®ciency of Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d disclosure will require an inquiry into both the 1601, 1606 (Fed. Cir. 1993) (rejecting the argument suf®ciency of the disclosed hardware as well as the that ªonly similar language in the speci®cation or disclosed software due to the interrelationship and original claims is necessary to satisfy the written interdependence of computer hardware and software. description requirementº). For example, in LizardTech, the claim was directed to a method of When examining computer-implemented functional compressing digital images using seamless discrete claims, examiners should determine whether the wavelet transformation (ªDWTº). The court found speci®cation discloses the computer and the that the claim covered all ways of performing algorithm (e.g., the necessary steps and/or DWT-based compression processes that lead to a ¯owcharts) that perform the claimed function in seamless DWT because there were no limitations as suf®cient detail such that one of ordinary skill in the to how the seamless DWT was to be accomplished. art can reasonably conclude that the inventor However, the speci®cation provided only one invented the claimed subject matter. Speci®cally, if method for creating a seamless DWT, and there was one skilled in the art would know how to program

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the disclosed computer to perform the necessary Inc., 214 USPQ 796, 824 (S.D. Mich. 1982), aff'd steps described in the speci®cation to achieve the on related grounds, 713 F.2d 788, 218 USPQ 961 claimed function and the inventor was in possession (Fed. Cir. 1983). See also MPEP § 2165 - § 2165.04. of that knowledge, the written description requirement would be satis®ed. Id. If the There are two factual inquiries to be made in speci®cation does not provide a disclosure of the determining whether a speci®cation satis®es the best computer and algorithm in suf®cient detail to mode requirement. First, there must be a subjective demonstrate to one of ordinary skill in the art that determination as to whether at the time the the inventor possessed the invention including how application was ®led, the inventor knew of a best to program the disclosed computer to perform the mode of practicing the invention. Second, if the claimed function, a rejection under 35 U.S.C. 112(a) inventor had a best mode of practicing the invention or pre-AIA 35 U.S.C. 112, ®rst paragraph, for lack in mind, there must be an objective determination of written description must be made. For more as to whether that best mode was disclosed in information regarding the written description suf®cient detail to allow one skilled in the art to requirement, see MPEP § 2161.01- § 2163.07(b). If practice it. Fonar Corp. v. Gen. Elect. Co., 107 F.3d the speci®cation does not provide a disclosure of 1543, 41 USPQ2d 1801, 1804 (Fed. Cir. 1997); suf®cient corresponding structure, materials, or acts Chemcast Corp. v. Arco Indus., 913 F.2d 923, that perform the entire claimed function of a means- 927-28, 16 USPQ2d 1033, 1036 (Fed. Cir. 1990). (or step-) plus- function limitation in a claim under ªAs a general rule, where software constitutes part 35 U.S.C. 112(f) or the sixth paragraph of pre-AIA of a best mode of carrying out an invention, 35 U.S.C. 112, "the applicant has in effect failed to description of such a best mode is satis®ed by a particularly point out and distinctly claim the disclosure of the functions of the software. This is invention" as required by the 35 U.S.C. 112(b) [or because, normally, writing code for such software the second paragraph of pre-AIA 35 U.S.C. 112]. is within the skill of the art, not requiring undue In re Donaldson Co., 16 F.3d 1189, 1195, 29 experimentation, once its functions have been USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). A disclosed. . . . [F]low charts or source code listings rejection under 35 U.S.C. 112(b) or the second are not a requirement for adequately disclosing the paragraph of pre-AIA 35 U.S.C. 112 must be made functions of software.º Fonar Corp., 107 F.3d at in addition to the written description rejection. 1549, 41 USPQ2d at 1805 (citations omitted).

II. BEST MODE III. DETERMINING WHETHER THE FULL SCOPE OF A COMPUTER-IMPLEMENTED FUNCTIONAL The purpose of the best mode requirement is to CLAIM LIMITATION IS ENABLED ªrestrain inventors from applying for patents while at the same time concealing from the public the To satisfy the enablement requirement of 35 U.S.C. preferred embodiments of their inventions which 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, they have in fact conceived.º In re Gay, 309 F.2d the speci®cation must teach those skilled in the art 769, 772, 135 USPQ 311, 315 (CCPA 1962). Only how to make and use the full scope of the claimed evidence of concealment, ªwhether accidental or invention without ªundue experimentation.º See, intentional,º is considered in judging the adequacy e.g., In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d of the disclosure for compliance with the best mode 1510, 1513 (Fed. Cir. 1993); In re Wands, 858 F.2d requirement. Spectra-Physics, Inc. v. Coherent, 731, 736-37, 8 USPQ2d 1400, 1402 (Fed. Cir. 1988). Inc.,827 F.2d 1524, 1535, 3 USPQ 2d 1737, 1745 In In re Wands, the court set forth the following (Fed. Cir. 1987). That evidence, in order to result in factors to consider when determining whether undue af®rmance of a best mode rejection, must tend to experimentation is needed: (1) the breadth of the show that the quality of an applicant's best mode claims; (2) the nature of the invention; (3) the state disclosure is so poor as to effectively result in of the prior art; (4) the level of one of ordinary skill; concealment.º In re Sherwood, 613 F.2d 809, (5) the level of predictability in the art; (6) the 816-817, 204 USPQ 537, 544 (CCPA 1980). Also, amount of direction provided by the inventor; (7) see White Consol. Indus. v. Vega Servo-Control the existence of working examples; and (8) the

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quantity of experimentation needed to make or use knowledge is enriched by the patent speci®cation to the invention based on the content of the disclosure. a degree at least commensurate with the scope of Wands, 858 F.2d at 737, 8 USPQ2d 1404. The the claims.º) (quotation omitted). undue experimentation determination is not a single factual determination. Rather, it is a conclusion For example, the claims in Sitrick were directed to reached by weighing all the factual considerations. ªintegratingº or ªsubstitutingº a user's audio signal Id. or visual image into a pre-existing video game or movie. While the claims covered both video games When basing a rejection on the failure of the and movies, the speci®cation only taught the skilled applicant's disclosure to meet the enablement artisan how to substitute and integrate user images provisions of 35 U.S.C. 112(a) or the ®rst paragraph into video games. The Federal Circuit held that the of pre-AIA 35 U.S.C. 112, USPTO personnel must speci®cation failed to enable the full scope of the establish on the record a reasonable basis for claims because the skilled artisan could not substitute questioning the adequacy of the disclosure to enable a user image for a preexisting character image in a person of ordinary skill in the art to make and use movies without undue experimentation. Speci®cally, the claimed invention without resorting to undue the court recognized that one skilled in the art could experimentation. See In re Brown, 477 F.2d 946, not apply the teachings of the speci®cation regarding 177 USPQ 691 (CCPA 1973); In re Ghiron, 442 video games to movies, because movies, unlike video F.2d 985, 169 USPQ 723 (CCPA 1971). Once games, do not have easily separable character USPTO personnel have advanced a reasonable basis functions. Because the speci®cation did not teach for questioning the adequacy of the disclosure, it how the substitution and integration of character becomes incumbent on the applicant to rebut that functions for a user image would be accomplished challenge and factually demonstrate that his or her in movies, the claims were not enabled. Sitrick, 516 application disclosure is in fact suf®cient. See In re F.3d at 999-1001, 85 USPQ2d at 1830-32. Doyle, 482 F.2d 1385, 1392, 179 USPQ 227, 232 (CCPA 1973); In re Scarbrough, 500 F.2d 560, 566, In Magsil Corp. v. Hitachi Global Storage 182 USPQ 298, 302 (CCPA 1974); In re Ghiron, Technologies, 687 F.3d 1377, 103 USPQ2d 1769 supra. See also MPEP § 2164 - § 2164.08(c). (Fed. Cir. 2012), the Federal Circuit stated that ªa patentee chooses broad claim language at the peril Functional claim language may render the claims of losing any claim that cannot be enabled across its broad when the claim is not limited to any particular full scope of coverage,º ®nding ªone skilled in the structure for performing the claimed function. In re art could not have taken the disclosure in the Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 229 speci®cation regarding `change in the resistance by (CCPA 1971). Since such a claim covers all devices at least 10% at room temperature' and achieved a which perform the recited function, there is a concern change in resistance in the full scope of that term regarding whether the scope of enablement provided without undue experimentation ¼ [t]hus, the to one skilled in the art by the disclosure is speci®cation enabled a marginal advance over the commensurate with the scope of protection sought prior art, but did not enable at the time of ®ling.º by the claim. Id; AK Steel Corp. v. Sollac, 344 F.3d The court held that the ªclaims [were] invalid for 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. lack of enablement because their broad scope [was] 2003); In re Moore, 439 F.2d 1232, 1236, 169 not reasonably supported by the scope of enablement USPQ 236, 239 (CCPA 1971). Applicants who in the speci®cation.º 687 F.3d at 1381-1382, 1384, present broad claim language must ensure the claims 103 USPQ2d at 1771, 1772, 1774. See also are fully enabled. Speci®cally, the scope of the Convolve, Inc. v. Compaq Computer Corp., 527 claims must be less than or equal to the scope of the F.App'x 910, 931 (Fed. Cir. 2013) enablement provided by the speci®cation. Sitrick (non-precedential), quoting Magsil Corp.)( ªBy v. Dreamworks, LLC, 516 F.3d 993, 999, 85 choosing such broad claim language, [patentee] put USPQ2d 1826, 1830 (Fed. Cir. 2008) (ªThe scope itself `at the peril of losing any claim that cannot be of the claims must be less than or equal to the scope enabled across its full scope of coverage.'º). of the enablement to ensure that the public

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The speci®cation need not teach what is well known impact sensor, and thus, it failed to apprise one of in the art. However, applicant cannot rely on the ordinary skill how to make and use the electronic knowledge of one skilled in the art to supply sensor. Since the novel aspect of the invention was information that is required to enable the novel side impact sensors, the patentee could not rely on aspect of the claimed invention when the enabling the knowledge of one skilled in the art to supply the knowledge is in fact not known in the art. ALZA missing information. Auto. Technologies, 501 F.3d Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 941, at 1283, 84 USPQ2d at 1114. 94 USPQ2d 1823, 1827 (Fed. Cir. 2010) (ªALZA was required to provide an adequate enabling A rejection under 35 U.S.C. 112(a) or pre-AIA 35 disclosure in the speci®cation; it cannot simply rely U.S.C. 112, ®rst paragraph for lack of enablement on the knowledge of a person of ordinary skill to must be made when the speci®cation does not enable serve as a substitute for the missing information in the full scope of the claim. USPTO personnel should the speci®cation.º); Auto. Techs. Int'l, Inc. v. BMW establish a reasonable basis to question the of N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d enablement provided for the claimed invention and 1108, 1114-15 (Fed. Cir. 2007) (ªAlthough the provide reasons for the uncertainty of the knowledge of one skilled in the art is indeed relevant, enablement. For more information regarding the the novel aspect of an invention must be enabled in enablement requirement, see MPEP § 2164.01(a) - the patent.º). The Federal Circuit has stated that ª`[i]t MPEP § 2164.08(c), e.g., MPEP § 2164.06(c) on is the speci®cation, not the knowledge of one skilled examples of computer programming cases. in the art, that must supply the novel aspects of an invention in order to constitute adequate 2162 Policy Underlying 35 U.S.C. 112(a) or enablement.'º Auto. Technologies, 501 F.3d at 1283, Pre-AIA 35 U.S.C. 112, First Paragraph 84 USPQ2d at 1115 (quoting Genentech, Inc. v. [R-11.2013] Novo Nordisk A/S, 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997)). The rule that a To obtain a valid patent, a patent application must speci®cation need not disclose what is well known be ®led that contains a full and clear disclosure of in the art is ªmerely a rule of supplementation, not the invention in the manner prescribed by 35 U.S.C. a substitute for a basic enabling disclosure.º 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. Genentech, 108 F.3d at 1366, 42 USPQ2d 1005; The requirement for an adequate disclosure ensures see also ALZA Corp., 603 F.3d at 940-41, 94 that the public receives something in return for the USPQ2d at 1827. Therefore, the speci®cation must exclusionary rights that are granted to the inventor contain the information necessary to enable the novel by a patent. The grant of a patent helps to foster and aspects of the claimed invention. Id. at 941, 94 enhance the development and disclosure of new ideas USPQ2d at 1827; Auto. Technologies, 501 F.3d at and the advancement of scienti®c knowledge. Upon 1283-84, 84 USPQ2d at 1115 (ª[T]he `omission of the grant of a patent in the U.S., information minor details does not cause a speci®cation to fail contained in the patent becomes a part of the to meet the enablement requirement. However, when information available to the public for further there is no disclosure of any speci®c starting material research and development, subject only to the or of any of the conditions under which a process patentee's right to exclude others during the life of can be carried out, undue experimentation is the patent. required.'º) (quoting Genentech, 108 F.3d at 1366, 42 USPQ2d at 1005). For instance, in Auto. Technologies, the claim limitation ªmeans responsive In exchange for the patent rights granted, 35 U.S.C. to the motion of said massº was construed to include 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, both mechanical side impact sensors and electronic sets forth the minimum requirements for the quality side impact sensors for performing the function of and quantity of information that must be contained initiating an occupant protection apparatus. Auto. in the patent to justify the grant. As discussed in Technologies, 501 F.3d at 1282, 84 USPQ2d at 1114. more detail below, the patentee must disclose in the The speci®cation did not disclose any discussion of patent suf®cient information to put the public in the details or circuitry involved in the electronic side possession of the invention and to enable those skilled in the art to make and use the invention. The

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applicant must not conceal from the public the best DESCRIPTIONº REQUIREMENT FOR way of practicing the invention that was known to APPLICATIONS the patentee at the time of ®ling the patent application. Failure to fully comply with the 35 U.S.C. 112(a) and the ®rst paragraph of pre-AIA disclosure requirements could result in the denial of 35 U.S.C. 112 require that the ªspeci®cation shall a patent, or in a holding of invalidity of an issued contain a written description of the invention ....º patent. This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli 2163 Guidelines for the Examination of Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, Patent Applications Under the 35 U.S.C. 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. 112(a) or Pre-AIA 35 U.S.C. 112, para. 1, Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991). See also Univ. of Rochester ªWritten Descriptionº Requirement v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 [R-07.2015] USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing history and purpose of the written description The following Guidelines establish the policies and requirement); In re Curtis, 354 F.3d 1347, 1357, 69 procedures to be followed by Of®ce personnel in USPQ2d 1274, 1282 (Fed. Cir. 2004) (ªconclusive the evaluation of any patent application for evidence of a claim's enablement is not equally compliance with the written description requirement conclusive of that claim's satisfactory written of 35 U.S.C. 112. These Guidelines are based on the descriptionº). The written description requirement Of®ce's current understanding of the law and are has several policy objectives. ª[T]he `essential goal' believed to be fully consistent with binding precedent of the description of the invention requirement is to of the U.S. Supreme Court, as well as the U.S. Court clearly convey the information that an applicant has of Appeals for the Federal Circuit and its predecessor invented the subject matter which is claimed.º In courts. re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to put The Guidelines do not constitute substantive the public in possession of what the applicant claims rulemaking and hence do not have the force and as the invention. See Regents of the Univ. of Cal. effect of law. They are designed to assist Of®ce v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, personnel in analyzing claimed subject matter for 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 compliance with substantive law. Rejections will be (1998). ªThe `written description' requirement based upon the substantive law, and it is these implements the principle that a patent must describe rejections which are appealable. Consequently, any the technology that is sought to be patented; the perceived failure by Of®ce personnel to follow these requirement serves both to satisfy the inventor's Guidelines is neither appealable nor petitionable. obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate These Guidelines are intended to form part of the that the patentee was in possession of the invention normal examination process. Thus, where Of®ce that is claimed.º Capon v. Eshhar, 418 F.3d 1349, personnel establish a prima facie case of lack of 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). written description for a claim, a thorough review Further, the written description requirement of the prior art and examination on the merits for promotes the progress of the useful arts by ensuring compliance with the other statutory requirements, that patentees adequately describe their inventions including those of 35 U.S.C. 101, 102, 103, and 112, in their patent speci®cations in exchange for the right is to be conducted prior to completing an Of®ce to exclude others from practicing the invention for action which includes a rejection for lack of written the duration of the patent's term. description. To satisfy the written description requirement, a I. GENERAL PRINCIPLES GOVERNING patent speci®cation must describe the claimed COMPLIANCE WITH THE ªWRITTEN invention in suf®cient detail that one skilled in the art can reasonably conclude that the inventor had

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possession of the claimed invention. See, e.g., speci®cation may show actual reduction to practice Moba, B.V. v. Diamond Automation, Inc., 325 F.3d by describing testing of the claimed invention or, in 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. the case of certain biological materials, by 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at speci®cally describing a deposit made in accordance 1563, 19 USPQ2d at 1116. However, a showing of with 37 CFR 1.801 et seq. See Enzo Biochem, 323 possession alone does not cure the lack of a written F.3d at 965, 63 USPQ2d at 1614 (ªreference in the description. Enzo Biochem, Inc. v. Gen-Probe, Inc., speci®cation to a deposit may also satisfy the written 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. description requirement with respect to a claimed Cir. 2002). While early opinions suggested that the materialº); see also Deposit of Biological Materials Patent and Trademark Of®ce was unwilling to ®nd for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 written descriptive support when the only description (August 22, 1989) (ªThe requirement for a speci®c was found in the claims, this viewpoint was rejected. identi®cation is consistent with the description See In re Koller, 613 F.2d 819, 204 USPQ 702 requirement of the ®rst paragraph of 35 U.S.C. 112, (CCPA 1980) (original claims constitute their own and to provide an antecedent basis for the biological description); accord In re Gardner, 475 F.2d 1389, material which either has been or will be deposited 177 USPQ 396 (CCPA 1973); accord In re before the patent is granted.º Id. at 34,876. ªThe Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA description must be suf®cient to permit veri®cation 1976). It is now well accepted that a satisfactory that the deposited biological material is in fact that description may be in the claims or any other portion disclosed. Once the patent issues, the description of the originally ®led speci®cation. These early must be suf®cient to aid in the resolution of opinions did not address the quality or speci®city of questions of infringement.º Id. at 34,880.) Such a particularity that was required in the description, deposit is not a substitute for a written description i.e., how much description is enough. of the claimed invention. The written description of the deposited material needs to be as complete as An applicant shows possession of the claimed possible because the examination for patentability invention by describing the claimed invention with proceeds solely on the basis of the written all of its limitations using such descriptive means as description. See, e.g., In re Lundak, 773 F.2d 1216, words, structures, ®gures, diagrams, and formulas 227 USPQ 90 (Fed. Cir. 1985). See also 54 Fed. that fully set forth the claimed invention. Lockwood Reg. at 34,880 (ªAs a general rule, the more v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, information that is provided about a particular 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession deposited biological material, the better the examiner may be shown in a variety of ways including will be able to compare the identity and description of an actual reduction to practice, or by characteristics of the deposited biological material showing that the invention was ªready for patentingº with the prior art.º). such as by the disclosure of drawings or structural chemical formulas that show that the invention was A question as to whether a speci®cation provides an complete, or by describing distinguishing identifying adequate written description may arise in the context characteristics suf®cient to show that the applicant of determining whether an original claim is described was in possession of the claimed invention. See, e.g., suf®ciently (see, e.g., LizardTech, Inc. v. Earth Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. Resource Mapping, Inc., 424 F.3d 1336, 1345, 76 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, USPQ2d 1724, 1733 (Fed. Cir. 2005); Enzo 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. Biochem, 323 F.3d at 968, 63 USPQ2d at 1616 (Fed. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d Cir. 2002); Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must de®ne a 1398), whether new or amended claims are supported compound by ªwhatever characteristics suf®ciently by the description of the invention in the application distinguish itº). ªCompliance with the written as ®led (see, e.g., In re Wright, 866 F.2d 422, 9 description requirement is essentially a fact-based USPQ2d 1649 (Fed. Cir. 1989)), whether a claimed inquiry that will `necessarily vary depending on the invention is entitled to the bene®t of an earlier nature of the invention claimed.'º Enzo Biochem, priority date or effective ®ling date under 35 U.S.C. 323 F.3d at 963, 63 USPQ2d at 1613. An application 119, 120, 365, or 386 (see, e.g., New Railhead Mfg.

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L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 63 The claimed invention as a whole may not be USPQ2d 1843 (Fed. Cir. 2002); Tronzo v. Biomet, adequately described where an invention is described Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. solely in terms of a method of its making coupled 1998); Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d with its function and there is no described or art 1601 (Fed. Cir. 1993); In re Ziegler, 992 F.2d 1197, recognized correlation or relationship between the 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993)), or structure of the invention and its function. A whether a speci®cation provides support for a claim biomolecule sequence described only by a functional corresponding to a count in an interference (see, e.g., characteristic, without any known or disclosed Martin v. Mayer, 823 F.2d 500, 503, 3 USPQ2d correlation between that function and the structure 1333, 1335 (Fed. Cir. 1987); Fields v. Conover, 443 of the sequence, normally is not a suf®cient F.2d 1386, 170 USPQ 276 (CCPA 1971)). identifying characteristic for written description Compliance with the written description requirement purposes, even when accompanied by a method of is a question of fact which must be resolved on a obtaining the claimed sequence. For example, even case-by-case basis. Vas-Cath, Inc. v. Mahurkar, 935 though a genetic code table would correlate a known F.2d at 1563, 19 USPQ2d at 1116 (Fed. Cir. 1991). amino acid sequence with a genus of coding nucleic acids, the same table cannot predict the native, A. Original Claims naturally occurring nucleic acid sequence of a naturally occurring mRNA or its corresponding There is a presumption that an adequate written cDNA. Cf. In re Bell, 991 F.2d 781, 26 USPQ2d description of the claimed invention is present when 1529 (Fed. Cir. 1993), and In re Deuel, 51 F.3d the application is ®led. In re Wertheim, 541 F.2d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding 257, 263, 191 USPQ 90, 97 (CCPA 1976) (ªwe are that a process could not render the product of that of the opinion that the PTO has the initial burden of process obvious under 35 U.S.C. 103). The Federal presenting evidence or reasons why persons skilled Circuit has pointed out that under United States law, in the art would not recognize in the disclosure a a description that does not render a claimed invention description of the invention de®ned by the claimsº). obvious cannot suf®ciently describe the invention However, as discussed in subsection I., supra, the for the purposes of the written description issue of a lack of adequate written description may requirement of 35 U.S.C. 112. Eli Lilly, 119 F.3d arise even for an original claim when an aspect of at 1567, 43 USPQ2d at 1405. Compare Fonar Corp. the claimed invention has not been described with v. Gen. Elec. Co., 107 F.3d 1543, 1549, 41 USPQ2d suf®cient particularity such that one skilled in the 1801, 1805 (Fed. Cir. 1997) (ªAs a general rule, art would recognize that the applicant had possession where software constitutes part of a best mode of of the claimed invention. The claimed invention as carrying out an invention, description of such a best a whole may not be adequately described if the mode is satis®ed by a disclosure of the functions of claims require an essential or critical feature which the software. This is because, normally, writing code is not adequately described in the speci®cation and for such software is within the skill of the art, not which is not conventional in the art or known to one requiring undue experimentation, once its functions of ordinary skill in the art. For example, consider have been disclosed.... Thus, ¯ow charts or source the claim ªA gene comprising SEQ ID NO:1.º A code listings are not a requirement for adequately determination of what the claim as a whole covers disclosing the functions of software.º). may result in a conclusion that speci®c structures such as a promoter, a coding region, or other A lack of adequate written description issue also elements are included. Although all genes arises if the knowledge and level of skill in the art encompassed by this claim share the characteristic would not permit one skilled in the art to of comprising SEQ ID NO:1, there may be immediately envisage the product claimed from the insuf®cient description of those speci®c structures disclosed process. See, e.g., Fujikawa v. Wattanasin, (e.g., promoters, enhancers, coding regions, and 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. other regulatory elements) which are also included. Cir. 1996) (a ªlaundry listº disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus

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because it would not ªreasonably leadº those skilled 169 USPQ 795 (CCPA 1971) (subgenus range was in the art to any particular species); In re Ruschig, not supported by generic disclosure and speci®c 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA example within the subgenus range); In re Smith, 1967) (ª If n-propylamine had been used in making 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA the compound instead of n-butylamine, the 1972) (a subgenus is not necessarily described by a compound of claim 13 would have resulted. genus encompassing it and a species upon which it Appellants submit to us, as they did to the board, an reads). imaginary speci®c example patterned on speci®c example 6 by which the above butyl compound is While there is no in haec verba requirement, newly made so that we can see what a simple change would added claim limitations must be supported in the have resulted in a speci®c supporting disclosure speci®cation through express, implicit, or being present in the present speci®cation. The inherent disclosure. An amendment to correct an trouble is that there is no such disclosure, easy obvious error does not constitute new matter where though it is to imagine it.º) (emphasis in original); one skilled in the art would not only recognize Purdue Pharma L.P. v. Faulding Inc., 230 F.3d the existence of the error in the speci®cation, but 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000) also recognize the appropriate correction. In re Oda, (ªthe speci®cation does not clearly disclose to the 443 F.2d 1200, 170 USPQ 268 (CCPA 1971). With skilled artisan that the inventors ... considered the respect to the correction of sequencing errors in ratio... to be part of their invention .... There is applications disclosing nucleic acid and/or amino therefore no force to Purdue's argument that the acid sequences, it is well known that sequencing written description requirement was satis®ed because errors are a common problem in molecular biology. the disclosure revealed a broad invention from which See, e.g., Peter Richterich, Estimation of Errors in the [later-®led] claims carved out a patentable `Raw' DNA Sequences: A Validation Study, 8 portionº). Genome Research 251-59 (1998). If an application as ®led includes sequence information and references B. New or Amended Claims a deposit of the sequenced material made in accordance with the requirements of 37 CFR 1.801 The proscription against the introduction of new et seq., amendment may be permissible. Deposits matter in a patent application (35 U.S.C. 132 and made after the application ®ling date cannot be relied 251) serves to prevent an applicant from adding upon to support additions to or correction of information that goes beyond the subject matter information in the application as ®led. Corrections originally ®led. See In re Rasmussen, 650 F.2d of minor errors in the sequence may be possible 1212, 1214, 211 USPQ 323, 326 (CCPA 1981). See based on the argument that one of skill in the art MPEP § 2163.06 through § 2163.07 for a more would have resequenced the deposited material and detailed discussion of the written description would have immediately recognized the minor error. requirement and its relationship to new matter. The Deposits made after the ®ling date can only be relied claims as ®led in the original speci®cation are part upon to provide support for the correction of of the disclosure and, therefore, if an application as sequence information if applicant submits a originally ®led contains a claim disclosing material statement in compliance with 37 CFR 1.804 stating not found in the remainder of the speci®cation, the that the biological material which is deposited is a applicant may amend the speci®cation to include biological material speci®cally de®ned in the the claimed subject matter. In re Benno, 768 F.2d application as ®led. 1340, 226 USPQ 683 (Fed. Cir. 1985). Thus, the written description requirement prevents an applicant Under certain circumstances, omission of a limitation from claiming subject matter that was not adequately can raise an issue regarding whether the inventor described in the speci®cation as ®led. New or had possession of a broader, more generic invention. amended claims which introduce elements or See, e.g., PIN/NIP, Inc. v. Platte Chem. Co., 304 limitations which are not supported by the as-®led F.3d 1235, 1248, 64 USPQ2d 1344, 1353 (Fed. Cir. disclosure violate the written description 2002) (Claim for a method of inhibiting sprout requirement. See, e.g., In re Lukach, 442 F.2d 967, growth on tubers by treating them with spaced,

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sequential application of two chemicals was held or pre-AIA 35 U.S.C. 112, para. 2. See In re invalid for lack of adequate written description where Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA the speci®cation indicated that invention was a 1976); In re Venezia, 530 F.2d 956, 189 USPQ 149 method of applying a ªcomposition,º or mixture, of (CCPA 1976); and In re Collier, 397 F.2d 1003, the two chemicals.); Gentry Gallery, Inc. v. Berkline 158 USPQ 266 (CCPA 1968). See also MPEP Corp., 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. § 2172.01. 1998) (claims to a sectional sofa comprising, inter alia, a console and a control means were held invalid The fundamental factual inquiry is whether the for failing to satisfy the written description speci®cation conveys with reasonable clarity to those requirement where the claims were broadened by skilled in the art that, as of the ®ling date sought, removing the location of the control means); applicant was in possession of the invention as now Johnson Worldwide Assoc. v. Zebco Corp., 175 F.3d claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 985, 993, 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) 1563-64, 19 USPQ2d at 1117. (In Gentry Gallery, the ªcourt's determination that the patent disclosure did not support a broad meaning II. METHODOLOGY FOR DETERMINING for the disputed claim terms was premised on clear ADEQUACY OF WRITTEN DESCRIPTION statements in the written description that described the location of a claim element--the `control means' A. Read and Analyze the Speci®cation for Compliance --as `the only possible location' and that variations with 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, para. were `outside the stated purpose of the invention.' 1 Gentry Gallery, 134 F.3d at 1479, 45 USPQ2d at 1503. Gentry Gallery, then, considers the situation Of®ce personnel should adhere to the following where the patent's disclosure makes crystal clear procedures when reviewing patent applications for that a particular (i.e., narrow) understanding of a compliance with the written description requirement claim term is an `essential element of [the inventor's] of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. invention.'º); Tronzo v. Biomet, 156 F.3d at 1. There is a presumption that an adequate written 1158-59, 47 USPQ2d at 1833 (Fed. Cir. 1998) description of the claimed invention is present in the (claims to generic cup shape were not entitled to speci®cation as ®led, Wertheim, 541 F.2d at 262, ®ling date of parent application which disclosed 191 USPQ at 96, thus the examiner has the initial ªconical cupº in view of the disclosure of the parent burden, after a thorough reading and evaluation of application stating the advantages and importance the content of the application, of presenting evidence of the conical shape.). A claim that omits an element or reasons why a person skilled in the art would not which applicant describes as an essential or critical recognize that the written description of the invention feature of the invention originally disclosed does not provides support for the claims. While it is not comply with the written description requirement. necessary for the examiner to present factual See Gentry Gallery, 134 F.3d at 1480, 45 USPQ2d evidence, to make a prima facie case it is necessary at 1503; In re Sus, 306 F.2d 494, 504, 134 USPQ to point out the claim limitations that are not 301, 309 (CCPA 1962) (ª[O]ne skilled in this art adequately supported and explain any other reasons would not be taught by the written description of the that the claim is not fully supported by the disclosure invention in the speci®cation that any `aryl or to show that the inventor had possession of the substituted aryl radical' would be suitable for the invention. See for example, Hyatt v. Dudas, 492 purposes of the invention but rather that only certain F.3d 1365, 1371, 83 USPQ2d 1373, 1376-1377 (Fed. aryl radicals and certain speci®cally substituted aryl Cir. 2007) in which the examiner made a prima radicals [i.e., aryl azides] would be suitable for such facie case by clearly and speci®cally explaining that purposes.º) (emphasis in original). A claim which the written description did not support the particular omits matter disclosed to be essential to the invention claimed combination of elements, even listing each as described in the speci®cation or in other and every element of the allegedly unsupported statements of record may also be subject to rejection combination. The court found the ªexaminer was under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, explicit that while each element may be individually para. 1, as not enabling, or under 35 U.S.C. 112(b) described in the speci®cation, the de®ciency was

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lack of adequate description of their combinationº 1. For Each Claim, Determine What the Claim as a and therefore ª[t]he burden was then properly shifted Whole Covers to [inventor] to cite to the examiner where adequate written description could be found or to make an Claim construction is an essential part of the amendment to address the de®ciency.º Id. See also examination process. Each claim must be separately Stored Value Solutions, Inc. v. Card Activation analyzed and given its broadest reasonable Technologies, 499 Fed.App'x 5, 13-14 (Fed. Cir. interpretation in light of and consistent with the 2012) (non-precedential) (The claims drawn to a written description. See, e.g., In re Katz Interactive method for processing debit purchase transactions, Call Processing Patent Litigation, 639 F.3d 1303, requiring three separate authorization codes, were 1319-1320, 97 USPQ2d 1737, 1750 (Fed. Cir. 2011) found to be invalid because ªthe written description (The court stated ª[t]he construction of the claims [did] not contain a method that include[d] all three [is] important to the written description analysisº codesº and ª[e]ach authorization code is an and patent holder's failure ªto point to a genuine important claim limitation, and the presence of factual dispute over whether the speci®cation multiple authorization codes in [the claim] was disclosedº the claimed subject matter made summary essentialº.). judgment proper.); In re Morris, 127 F.3d 1048, 1053-54, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). With respect to newly added or amended claims, The entire claim must be considered, including the applicant should show support in the original preamble language and the transitional phrase. disclosure for the new or amended claims. See MPEP ªPreamble languageº is that language in a claim § 714.02 and § 2163.06 (ªApplicant should ... appearing before the transitional phase, e.g., before speci®cally point out the support for any ªcomprising,º ªconsisting essentially of,º or amendments made to the disclosure.º); and MPEP ªconsisting of.º The transitional term ªcomprisingº § 2163.04 (ªIf applicant amends the claims and (and other comparable terms, e.g., ªcontaining,º and points out where and/or how the originally ®led ªincludingº) is ªopen-endedº -it covers the expressly disclosure supports the amendment(s), and the recited subject matter, alone or in combination with examiner ®nds that the disclosure does not unrecited subject matter. See, e.g., Genentech, Inc. reasonably convey that the inventor had possession v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d of the subject matter of the amendment at the time 1608, 1613 (Fed. Cir. 1997) (ª`Comprising' is a term of the ®ling of the application, the examiner has the of art used in claim language which means that the initial burden of presenting evidence or reasoning named elements are essential, but other elements to explain why persons skilled in the art would not may be added and still form a construct within the recognize in the disclosure a description of the scope of the claim.º); Ex parte Davis, 80 USPQ invention de®ned by the claims.º). The inquiry into 448, 450 (Bd. App. 1948) (ªcomprisingº leaves the whether the description requirement is met is a ªclaim open for the inclusion of unspeci®ed question of fact that must be determined on a ingredients even in major amountsº). See also MPEP case-by-case basis. AbbVie Deutschland GmbH & § 2111.03. ªBy using the term `consisting essentially Co., KG v. Janseen Biotech, Inc., 759 F.3d 1285, of,' the drafter signals that the invention necessarily 1297, 111 USPQ2d 1780, 1788 (Fed. Cir. 2014) includes the listed ingredients and is open to unlisted ("Whether a patent claim is supported by an adequate ingredients that do not materially affect the basic written description is a question of fact."); In re and novel properties of the invention. A `consisting Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 essentially of' claim occupies a middle ground (CCPA 1972) (ªPrecisely how close [to the claimed between closed claims that are written in a invention] the description must come to comply with `consisting of' format and fully open claims that are Sec. 112 must be left to case-by-case drafted in a `comprising' format.º PPG Indus. v. development.º); In re Wertheim, 541 F.2d at 262, Guardian Indus., 156 F.3d 1351, 1354, 48 USPQ2d 191 USPQ at 96 (inquiry is primarily factual and 1351, 1353-54 (Fed. Cir. 1998). For the purposes of depends on the nature of the invention and the searching for and applying prior art under 35 U.S.C. amount of knowledge imparted to those skilled in 102 and 103, absent a clear indication in the the art by the disclosure). speci®cation or claims of what the basic and novel

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characteristics actually are, ªconsisting essentially well-established terms or procedures should not be ofº will be construed as equivalent to ªcomprising.º the basis of a rejection under 35 U.S.C. 112(a) or See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at pre-AIA 35 U.S.C. 112, para. 1, for lack of adequate 1355 (ªPPG could have de®ned the scope of the written description. Limitations may not, however, phrase `consisting essentially of' for purposes of its be imported into the claims from the speci®cation. patent by making clear in its speci®cation what it regarded as constituting a material change in the 2. Review the Entire Application to Understand How basic and novel characteristics of the invention.º). Applicant Provides Support for the Claimed Invention See also AK Steel Corp. v. Sollac, 344 F3.d 1234, Including Each Element and/or Step 1239-1240, 68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003); In re Janakirama-Rao, 317 F.2d 951, 954, Prior to determining whether the disclosure satis®es 137 USPQ 893, 895-96 (CCPA 1963). If an applicant the written description requirement for the claimed contends that additional steps or materials in the subject matter, the examiner should review the prior art are excluded by the recitation of ªconsisting claims and the entire speci®cation, including the essentially of,º applicant has the burden of showing speci®c embodiments, ®gures, and sequence listings, that the introduction of additional steps or to understand how applicant provides support for components would materially change the the various features of the claimed invention. An characteristics of applicant's invention. In re De element may be critical where those of skill in the Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). art would require it to determine that applicant was See also MPEP § 2111.03. The claim as a whole, in possession of the invention. Compare Rasmussen, including all limitations found in the preamble (see 650 F.2d at 1215, 211 USPQ at 327 (ªone skilled in Pac-Tec Inc. v. Amerace Corp., 903 F.2d 796, 801, the art who read Rasmussen's speci®cation would 14 USPQ2d 1871, 1876 (Fed. Cir. 1990) understand that it is unimportant how the layers are (determining that preamble language that constitutes adhered, so long as they are adheredº) (emphasis in a structural limitation is actually part of the claimed original), with Amgen, Inc. v. Chugai Pharm.Co., invention)), the transitional phrase, and the body of Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 the claim, must be suf®ciently supported to satisfy (Fed. Cir. 1991) (ªit is well established in our law the written description requirement. An applicant that conception of a chemical compound requires shows possession of the claimed invention by that the inventor be able to de®ne it so as to describing the claimed invention with all of its distinguish it from other materials, and to describe limitations. Lockwood, 107 F.3d at 1572, how to obtain itº). The analysis of whether the 41 USPQ2d at 1966. speci®cation complies with the written description requirement calls for the examiner to compare the The examiner should evaluate each claim to scope of the claim with the scope of the description determine if suf®cient structures, acts, or functions to determine whether applicant has demonstrated are recited to make clear the scope and meaning of possession of the claimed invention. Such a review the claim, including the weight to be given the is conducted from the standpoint of one of skill in preamble. See, e.g., Bell Communications Research, the art at the time the application was ®led (see, e.g., Inc. v. Vitalink Communications Corp., 55 F.3d 615, Wang Labs. v. Toshiba Corp., 993 F.2d 858, 865, 620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995) (ª[A] 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should claim preamble has the import that the claim as a include a determination of the ®eld of the invention whole suggests for it.º); Corning Glass Works v. and the level of skill and knowledge in the art. For Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, some arts, there is an inverse correlation between 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The the level of skill and knowledge in the art and the determination of whether preamble recitations are speci®city of disclosure necessary to satisfy the structural limitations can be resolved only on review written description requirement. Information which of the entirety of the application ªto gain an is well known in the art need not be described in understanding of what the inventors actually detail in the speci®cation. See, e.g., Hybritech, Inc. invented and intended to encompass by the claim.º). v. Monoclonal Antibodies, Inc., 802 F.2d 1367, The absence of de®nitions or details for 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986).

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However, suf®cient information must be provided USPQ2d 1465, 1468 (Fed. Cir. 1987) (ª[T]here to show that the inventor had possession of the cannot be a reduction to practice of the invention ... invention as claimed. without a physical embodiment which includes all limitations of the claim.º); Estee Lauder Inc. v. 3. Determine Whether There is Suf®cient Written L'Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, Description to Inform a Skilled Artisan That Applicant 1614 (Fed. Cir. 1997) (ª[A] reduction to practice was in Possession of the Claimed Invention as a Whole does not occur until the inventor has determined that at the Time the Application Was Filed the invention will work for its intended purpose.º); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, (a) Original claims 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its Possession may be shown in many ways. For intended purpose may require testing depending on example, possession may be shown by describing the character of the invention and the problem it an actual reduction to practice of the claimed solves). Description of an actual reduction to practice invention. Possession may also be shown by a clear of a biological material may be shown by speci®cally depiction of the invention in detailed drawings or in describing a deposit made in accordance with the structural chemical formulas which permit a person requirements of 37 CFR 1.801 et seq. See especially skilled in the art to clearly recognize that applicant 37 CFR 1.804 and 1.809. See also subsection I., had possession of the claimed invention. An supra. adequate written description of the invention may be shown by any description of suf®cient, relevant, An applicant may show possession of an invention identifying characteristics so long as a person skilled by disclosure of drawings or structural chemical in the art would recognize that the inventor had formulas that are suf®ciently detailed to show that possession of the claimed invention. See, e.g., applicant was in possession of the claimed invention Purdue Pharma L.P. v. Faulding Inc., 230 F.3d as a whole. See, e.g., Vas-Cath, 935 F.2d at 1565, 1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000) 19 USPQ2d at 1118 (ªdrawings alone may provide (the written description ªinquiry is a factual one and a `written description' of an invention as required must be assessed on a case-by-case basisº); see also by Sec. 112º); In re Wolfensperger, 302 F.2d 950, Pfaff v. Wells Elect., Inc., 55 U.S. at 66, 119 S.Ct. 133 USPQ 537 (CCPA 1962) (the drawings of at 311, 48 USPQ2d at 1646 (ªThe word `invention' applicant's speci®cation provided suf®cient written must refer to a concept that is complete, rather than descriptive support for the claim limitation at issue); merely one that is `substantially complete.' It is true Autogiro Co. of Am. v. United States, 384 F.2d 391, that reduction to practice ordinarily provides the best 398, 155 USPQ 697, 703 (Ct. Cl. 1967) (ªIn those evidence that an invention is complete. But just instances where a visual representation can ¯esh out because reduction to practice is suf®cient evidence words, drawings may be used in the same manner of completion, it does not follow that proof of and with the same limitations as the speci®cation.º); reduction to practice is necessary in every case. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (ªIn Indeed, both the facts of the Telephone Cases and claims involving chemical materials, generic the facts of this case demonstrate that one can prove formulae usually indicate with speci®city what the that an invention is complete and ready for patenting generic claims encompass. One skilled in the art can before it has actually been reduced to practice.º). distinguish such a formula from others and can identify many of the species that the claims A speci®cation may describe an actual reduction to encompass. Accordingly, such a formula is normally practice by showing that the inventor constructed an an adequate description of the claimed genus.º). The embodiment or performed a process that met all the description need only describe in detail that which limitations of the claim and determined that the is new or not conventional. See Hybritech v. invention would work for its intended purpose. Monoclonal Antibodies, 802 F.2d at 1384, 231 USPQ Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 at 94. This is equally true whether the claimed USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC invention is directed to a product or a process. Elecs. Co. v. United States, 816 F.2d 647, 652, 2

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An applicant may also show that an invention is chemical name, physical properties, or deposit in a complete by disclosure of suf®ciently detailed, public depository provides an adequate written relevant identifying characteristics which provide description of an antibody claimed by its binding evidence that applicant was in possession of the af®nity to that antigen, if ªgenerating the claimed claimed invention, i.e., complete or partial structure, antibody is so routine that possessing the [antigen] other physical and/or chemical properties, functional places the applicant in possession of an antibody.º characteristics when coupled with a known or Centocor Ortho Biotech, Inc. v. Abbott disclosed correlation between function and structure, Laboratories, 636 F.3d 1341, 1351-52, 97 USPQ2d or some combination of such characteristics. Enzo 1870, 1877 (Fed. Cir. 2011), distinguishing Noelle Biochem, 323 F.3d at 964, 63 USPQ2d at 1613. For v. Lederman, 355 F.3d 1343, 1349, 69 USPQ2d example, the presence of a restriction enzyme map 1508, 1514 (Fed. Cir. 2004) (holding there is a lack of a gene may be relevant to a statement that the of written descriptive support for an antibody de®ned gene has been isolated. One skilled in the art may by its binding af®nity to an antigen that itself was be able to determine whether the gene disclosed is not adequately described). ). In Centocor, the patent the same as or different from a gene isolated by at issue claimed antibodies with speci®c properties another by comparing the restriction enzyme maps. including high af®nity to a particular antigen. The In contrast, evidence that the gene could be digested patent did disclose the antigen, but did not disclose with a nuclease would not normally represent a any antibodies with the speci®c claimed properties. relevant characteristic since any gene would be The court held that the claimed antibodies were not digested with a nuclease. Similarly, isolation of an adequately described, because as of the priority date mRNA and its expression to produce the protein of of the patent, the generation of such antibodies was interest is strong evidence of possession of an mRNA not possible using conventional, routine or for the protein. well-developed technology. Additionally, unique cleavage by particular enzymes, isoelectric points For some biomolecules, examples of identifying of fragments, detailed restriction enzyme maps, a characteristics include a sequence, structure, binding comparison of enzymatic activities, or antibody af®nity, binding speci®city, molecular weight, and cross-reactivity may be suf®cient to show possession length. Although structural formulas provide a of the claimed invention to one of skill in the art. convenient method of demonstrating possession of See Lockwood, 107 F.3d at 1572, 41 USPQ2d at speci®c molecules, other identifying characteristics 1966 (ªwritten descriptionº requirement may be or combinations of characteristics may demonstrate satis®ed by using ªsuch descriptive means as words, the requisite possession. As explained by the Federal structures, ®gures, diagrams, formulas, etc., that Circuit, ª(1) examples are not necessary to support fully set forth the claimed inventionº). A de®nition the adequacy of a written description; (2) the written by function alone ªdoes not suf®ceº to suf®ciently description standard may be met ¼ even where describe a coding sequence ªbecause it is only an actual reduction to practice of an invention is absent; indication of what the gene does, rather than what and (3) there is no per se rule that an adequate it is.º Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. written description of an invention that involves a See also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at biological macromolecule must contain a recitation 1605-06 (discussing Amgen Inc. v. Chugai Pharm. of known structure.º Falkner v. Inglis, 448 F.3d Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1357, 1366, 79 USPQ2d 1001, 1007 (Fed. Cir. 1991)). An adequate written description of a 2006). See also Capon v. Eshhar, 418 F.3d at 1358, chemical invention also requires a precise de®nition, 76 USPQ2d at 1084 (ªThe Board erred in holding such as by structure, formula, chemical name, or that the speci®cations do not meet the written physical properties, and not merely a wish or plan description requirement because they do not reiterate for obtaining the chemical invention claimed. See, the structure or formula or chemical name for the e.g., Univ. of Rochester v. G.D. Searle & Co., 358 nucleotide sequences of the claimed chimeric genesº F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. where the genes were novel combinations of known 2004) (The patent at issue claimed a method of DNA segments.). For example, disclosure of an selectively inhibiting PGHS-2 activity by antigen fully characterized by its structure, formula, administering a non-steroidal compound that

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selectively inhibits activity of the PGHS-2 gene 1999); Biomedino, LLC v. Waters Technologies product, however the patent did not disclose any Corp., 490 F.3d 946, 953, 83 USPQ2d 1118, 1123 compounds that can be used in the claimed methods. (Fed. Cir. 2007) ("The inquiry is whether one of skill While there was a description of assays for screening in the art would understand the speci®cation itself compounds to identify those that inhibit the to disclose a structure, not simply whether that expression or activity of the PGHS-2 gene product, person would be capable of implementing a there was no disclosure of which peptides, structure."). Note also that a rejection under 35 polynucleotides, and small organic molecules U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, para. 2, selectively inhibit PGHS-2. The court held that ªcannot stand where there is adequate description ª[w]ithout such disclosure, the claimed methods in the speci®cation to satisfy 35 U.S.C. 112(a) or cannot be said to have been described.º). pre-AIA 35 U.S.C. 112, ®rst paragraph, regarding means-plus-function recitations that are not, per se, If a claim limitation invokes 35 U.S.C. 112(f) or challenged for being unclear.º In re Noll, 545 F.2d pre-AIA 35 U.S.C. 112, para. 6, it must be 141, 149, 191 USPQ 721, 727 (CCPA 1976). See interpreted to cover the corresponding structure, "Supplemental Examination Guidelines for materials, or acts in the speci®cation and Determining the Applicability of 35 U.S.C. 112, ªequivalents thereof.º See 35 U.S.C. 112(f) or para. 6," 65 Fed. Reg. 38510, June 21, 2000. See pre-AIA 35 U.S.C. 112, para. 6. See also B. Braun also MPEP § 2181. However, when a means- (or Medical, Inc. v. Abbott Lab., 124 F.3d 1419, 1424, step-) plus-function claim limitation is found to be 43 USPQ2d 1896, 1899 (Fed. Cir. 1997). In inde®nite based on failure of the speci®cation to considering whether there is 35 U.S.C. 112(a) or disclose suf®cient corresponding structure, materials, pre-AIA 35 U.S.C. 112, para. 1, support for a means- or acts that perform the entire claimed function, then (or step) plus- function claim limitation, the the claim limitation necessarily lacks an adequate examiner must consider not only the original written description. Thus, when a claim is rejected disclosure contained in the summary and detailed as inde®nite under 35 U.S.C. 112(b) or pre-AIA 35 description of the invention portions of the U.S.C. 112, second paragraph because there is no speci®cation, but also the original claims, abstract, corresponding structure, materials, or acts, or an and drawings. A means- (or step-) plus- function inadequate disclosure of corresponding structure, claim limitation is adequately described under 35 materials, or acts, for a means- (or step-) U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. 1, if: plus-function claim limitation, then the claim must (1) The written description adequately links or also be rejected under 35 U.S.C. 112(a) or pre-AIA associates adequately described particular structure, 35 U.S.C. 112, ®rst paragraph, for lack of an material, or acts to perform the function recited in a adequate written description. means- (or step-) plus- function claim limitation; or (2) it is clear based on the facts of the application What is conventional or well known to one of that one skilled in the art would have known what ordinary skill in the art need not be disclosed in structure, material, or acts disclosed in the detail. See Hybritech Inc. v. Monoclonal Antibodies, speci®cation perform the function recited in a means- Inc., 802 F.2d at 1384, 231 USPQ at 94. See also (or step-) plus- function limitation. See Aristocrat Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d Techs. Australia Pty Ltd. v. Int'l Game Tech., 521 1078, 1085 (Fed. Cir. 2005) (ªThe `written F.3d 1328, 1336-37, 86 USPQ2d 1235, 1242 (Fed. description' requirement must be applied in the Cir. 2008) ("©consideration of the understanding of context of the particular invention and the state of one skilled in the art in no way relieves the patentee the knowledge¼. As each ®eld evolves, the balance of adequately disclosing suf®cient structure in the also evolves between what is known and what is speci®cation.© It is not enough for the patentee added by each inventive contribution.º). If a skilled simply to state or later argue that persons of ordinary artisan would have understood the inventor to be in skill in the art would know what structures to use to possession of the claimed invention at the time of accomplish the claimed function."), quoting Atmel ®ling, even if every nuance of the claims is not Corp. v. Information Storage Devices, Inc., 198 F.3d explicitly described in the speci®cation, then the 1374, 1380, 53 USPQ2d 1225, 1229 (Fed. Cir. adequate description requirement is met. See, e.g.,

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Vas-Cath, 935 F.2d at 1563, 19 USPQ2d at 1116; rejection under 35 U.S.C. 112(a) or pre-AIA 35 Martin v. Johnson, 454 F.2d 746, 751, 172 USPQ U.S.C. 112, para. 1, for lack of written description 391, 395 (CCPA 1972) (stating ªthe description need must not be made. not be in ipsis verbis [i.e., ªin the same wordsº] to be suf®cientº). (2) If the application as ®led does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine A claim which is limited to a single disclosed whether the speci®cation discloses other relevant embodiment or species is analyzed as a claim drawn identifying characteristics suf®cient to describe the to a single embodiment or species, whereas a claim claimed invention in such full, clear, concise, and which encompasses two or more embodiments or exact terms that a skilled artisan would recognize species within the scope of the claim is analyzed as applicant was in possession of the claimed invention. a claim drawn to a genus. See also MPEP § For example, in the biotech art, if a strong correlation 806.04(e). has been established between structure and function, one skilled in the art would be able to predict with i) For Each Claim Drawn to a Single Embodiment or a reasonable degree of con®dence the structure of Species: the claimed invention from a recitation of its (A) Determine whether the application describes function. Thus, the written description requirement an actual reduction to practice of the claimed may be satis®ed through disclosure of function and invention. minimal structure when there is a well-established correlation between structure and function. In (B) If the application does not describe an actual contrast, without such a correlation, the capability reduction to practice, determine whether the to recognize or understand the structure from the invention is complete as evidenced by a reduction mere recitation of function and minimal structure is to drawings or structural chemical formulas that are highly unlikely. In this latter case, disclosure of suf®ciently detailed to show that applicant was in function alone is little more than a wish for possession of the claimed invention as a whole. possession; it does not satisfy the written description (C) If the application does not describe an actual requirement. See Eli Lilly, 119 F.3d at 1568, 43 reduction to practice or reduction to drawings or USPQ2d at 1406 (written description requirement structural chemical formula as discussed above, not satis®ed by merely providing ªa result that one determine whether the invention has been set forth might achieve if one made that inventionº); In re in terms of distinguishing identifying characteristics Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 as evidenced by other descriptions of the invention (Fed. Cir. 1984) (af®rming a rejection for lack of that are suf®ciently detailed to show that applicant written description because the speci®cation does was in possession of the claimed invention. ªlittle more than outline goals appellants hope the claimed invention achieves and the problems the (1) Determine whether the application as invention will hopefully ameliorateº). ®led describes the complete structure (or acts of a process) of the claimed invention as a whole. The Whether the speci®cation shows that applicant was complete structure of a species or embodiment in possession of the claimed invention is not a single, typically satis®es the requirement that the description simple determination, but rather is a factual be set forth ªin such full, clear, concise, and exact determination reached by considering a number of termsº to show possession of the claimed invention. factors. Factors to be considered in determining 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. whether there is suf®cient evidence of possession 1. Cf. Fields v. Conover, 443 F.2d 1386, 1392, 170 include the level of skill and knowledge in the art, USPQ 276, 280 (CCPA 1971) (®nding a lack of partial structure, physical and/or chemical properties, written description because the speci®cation lacked functional characteristics alone or coupled with a the ªfull, clear, concise, and exact written known or disclosed correlation between structure descriptionº which is necessary to support the and function, and the method of making the claimed claimed invention). If a complete structure is invention. Disclosure of any combination of such disclosed, the written description requirement is identifying characteristics that distinguish the satis®ed for that species or embodiment, and a

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claimed invention from other materials and would preparation, its physical or chemical properties, or lead one of skill in the art to the conclusion that the whatever characteristics suf®ciently distinguish it. applicant was in possession of the claimed species It is not suf®cient to de®ne it solely by its principal is suf®cient. See Eli Lilly, 119 F.3d at 1568, 43 biological property, e.g., encoding human USPQ2d at 1406. The description needed to satisfy erythropoietin, because an alleged conception having the requirements of 35 U.S.C. 112 ªvaries with the no more speci®city than that is simply a wish to nature and scope of the invention at issue, and with know the identity of any material with that biological the scienti®c and technologic knowledge already in property. We hold that when an inventor is unable existence.º Capon v. Eshhar, 418 F.3d at 1357, 76 to envision the detailed constitution of a gene so as USPQ2d at 1084. Patents and printed publications to distinguish it from other materials, as well as a in the art should be relied upon to determine whether method for obtaining it, conception has not been an art is mature and what the level of knowledge and achieved until reduction to practice has occurred, skill is in the art. In most technologies which are i.e., until after the gene has been isolated.º) (citations mature, and wherein the knowledge and level of skill omitted). In such instances the alleged conception in the art is high, a written description question fails not merely because the ®eld is unpredictable should not be raised for claims present in the or because of the general uncertainty surrounding application when originally ®led, even if the experimental sciences, but because the conception speci®cation discloses only a method of making the is incomplete due to factual uncertainty that invention and the function of the invention. undermines the speci®city of the inventor's idea of the invention. Burroughs Wellcome Co. v. Barr Lab. In contrast, for inventions in emerging and Inc., 40 F.3d 1223, 1229, 32 USPQ2d 1915, 1920 unpredictable technologies, or for inventions (Fed. Cir. 1994). Reduction to practice in effect characterized by factors not reasonably predictable provides the only evidence to corroborate conception which are known to one of ordinary skill in the art, (and therefore possession) of the invention. Id. more evidence is required to show possession. For example, disclosure of only a method of making the Any claim to a species that does not meet the test invention and the function may not be suf®cient to described under at least one of (a), (b), or (c) must support a product claim other than a be rejected as lacking adequate written description product-by-process claim. See, e.g., Fiers v. Revel, under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, para. 1. 927 F.2d at 1206, 18 USPQ2d at 1021. Where the process has actually been used to produce the ii) For each claim drawn to a genus: product, the written description requirement for a product-by-process claim is clearly satis®ed; The written description requirement for a claimed however, the requirement may not be satis®ed where genus may be satis®ed through suf®cient description it is not clear that the acts set forth in the of a representative number of species by actual speci®cation can be performed, or that the product reduction to practice (see i)(A), above), reduction is produced by that process. Furthermore, disclosure to drawings (see i)(B), above), or by disclosure of of a partial structure without additional relevant, identifying characteristics, i.e., structure characterization of the product may not be suf®cient or other physical and/or chemical properties, by to evidence possession of the claimed invention. functional characteristics coupled with a known or See, e.g., Amgen, 927 F.2d at 1206, 18 USPQ2d at disclosed correlation between function and structure, 1021 (ªA gene is a chemical compound, albeit a or by a combination of such identifying complex one, and it is well established in our law characteristics, suf®cient to show the applicant was that conception of a chemical compound requires in possession of the claimed genus (see i)(C), above). that the inventor be able to de®ne it so as to See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. distinguish it from other materials, and to describe how to obtain it. Conception does not occur unless A ªrepresentative number of speciesº means that the one has a mental picture of the structure of the species which are adequately described are chemical, or is able to de®ne it by its method of representative of the entire genus. Thus, when there

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is substantial variation within the genus, one must ªuse of known chemical compounds in a manner describe a suf®cient variety of species to re¯ect the auxiliary to the invention must have a corresponding variation within the genus. See AbbVie Deutschland written description only so speci®c as to lead one GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d having ordinary skill in the art to that class of 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. compounds. Occasionally, a functional recitation of 2014) (Claims directed to a functionally de®ned those known compounds in the speci®cation may genus of antibodies were not supported by a be suf®cient as that description.º); In re Smythe, disclosure that ªonly describe[d] one type of 480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA structurally similar antibodiesº that ªare not 1973) (the phrase ªair or other gas which is inert to representative of the full variety or scope of the the liquidº was suf®cient to support a claim to ªinert genus.º). The disclosure of only one species ¯uid mediaº because the description of the properties encompassed within a genus adequately describes a and functions of the air or other gas segmentizing claim directed to that genus only if the disclosure medium would suggest to a person skilled in the art ªindicates that the patentee has invented species that appellant's invention includes the use of ªinert suf®cient to constitute the gen[us].º See Enzo ¯uidº broadly.). Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 The Federal Circuit has explained that a speci®cation USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. cannot always support expansive claim language 2004) (ª[A] patentee of a biotechnological invention and satisfy the requirements of 35 U.S.C. 112 cannot necessarily claim a genus after only ªmerely by clearly describing one embodiment of describing a limited number of species because there the thing claimed.º LizardTech v. Earth Resource may be unpredictability in the results obtained from Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d species other than those speci®cally enumerated.º). 1731, 1733 (Fed. Cir. 2005). The issue is whether a ªA patentee will not be deemed to have invented person skilled in the art would understand applicant species suf®cient to constitute the genus by virtue to have invented, and been in possession of, the of having disclosed a single species when ¼ the invention as broadly claimed. In LizardTech, claims evidence indicates ordinary artisans could not predict to a generic method of making a seamless discrete the operability in the invention of any species other wavelet transformation (DWT) were held invalid than the one disclosed.º In re Curtis, 354 F.3d 1347, under 35 U.S.C. 112, ®rst paragraph, because the 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) speci®cation taught only one particular method for (Claims directed to PTFE dental ¯oss with a making a seamless DWT and there was no evidence friction-enhancing coating were not supported by a that the speci®cation contemplated a more generic disclosure of a microcrystalline wax coating where method. See also Tronzo v. Biomet, 156 F.3d at 1159, there was no evidence in the disclosure or anywhere 47 USPQ2d at 1833 (Fed. Cir. 1998), wherein the else in the record showing applicant conveyed that disclosure of a species in the parent application did any other coating was suitable for a PTFE dental not suf®ce to provide written description support for ¯oss.) On the other hand, there may be situations the genus in the child application where the where one species adequately supports a genus. See, speci®cation taught against other species. e.g., Rasmussen, 650 F.2d at 1214, 211 USPQ at 326-27 (disclosure of a single method of adheringly Satisfactory disclosure of a ªrepresentative numberº applying one layer to another was suf®cient to depends on whether one of skill in the art would support a generic claim to ªadheringly applyingº recognize that the applicant was in possession of the because one skilled in the art reading the necessary common attributes or features possessed speci®cation would understand that it is unimportant by the members of the genus in view of the species how the layers are adhered, so long as they are disclosed. For inventions in an unpredictable art, adhered); In re Herschler, 591 F.2d 693, 697, adequate written description of a genus which 200 USPQ 711, 714 (CCPA 1979) (disclosure of embraces widely variant species cannot be achieved corticosteroid in DMSO suf®cient to support claims by disclosing only one species within the genus. See, drawn to a method of using a mixture of a e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at ªphysiologically active steroidº and DMSO because 1406. Instead, the disclosure must adequately re¯ect

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the structural diversity of the claimed genus, either Priority Date or Filing Date under 35 U.S.C. 119, 120, through the disclosure of suf®cient species that are 365, or 386 ªrepresentative of the full variety or scope of the genus,º or by the establishment of ªa reasonable The examiner has the initial burden of presenting structure-function correlation.º Such correlations evidence or reasoning to explain why persons skilled may be established ªby the inventor as described in in the art would not recognize in the original the speci®cation,º or they may be ªknown in the art disclosure a description of the invention de®ned by at the time of the ®ling date.º See AbbVie, 759 F.3d the claims. See Wertheim, 541 F.2d at 263, 191 at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. USPQ at 97 (ª[T]he PTO has the initial burden of 2014) (Claims to all human antibodies that bind presenting evidence or reasons why persons skilled IL-12 with a particular koff rate constant were not in the art would not recognize in the disclosure a adequately disclosed by speci®cation describing description of the invention de®ned by the claims.º). only a single type of human antibody having a However, when ®ling an amendment an applicant particular type of heavy and light chain, because should show support in the original disclosure for such disclosure was not representative of other types new or amended claims. See MPEP § 714.02 and § of the claimed antibodies. For example, the 2163.06 (ªApplicant should ... speci®cally point out speci®cation failed to disclose other antibodies the support for any amendments made to the encompassed by the claimed genus that bound to disclosure.º). different epitopes on IL-12, had different types of heavy and light chains, and shared only a 50% To comply with the written description requirement sequence similarity in their variable regions with the of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. disclosed antibodies.). Description of a representative 1, or to be entitled to an earlier priority date or ®ling number of species does not require the description date under 35 U.S.C. 119, 120, 365, or 386, each to be of such speci®city that it would provide claim limitation must be expressly, implicitly, or individual support for each species that the genus inherently supported in the originally ®led embraces. For example, in the molecular biology disclosure. When an explicit limitation in a claim arts, if an applicant disclosed an amino acid ªis not present in the written description whose sequence, it would be unnecessary to provide an bene®t is sought it must be shown that a person of explicit disclosure of nucleic acid sequences that ordinary skill would have understood, at the time encoded the amino acid sequence. Since the genetic the patent application was ®led, that the description code is widely known, a disclosure of an amino acid requires that limitation.º Hyatt v. Boone, 146 F.3d sequence would provide suf®cient information such 1348, 1353, 47 USPQ2d 1128, 1131 (Fed. Cir. that one would accept that an applicant was in 1998). See also In re Wright, 866 F.2d 422, 425, 9 possession of the full genus of nucleic acids USPQ2d 1649, 1651 (Fed. Cir. 1989) (Original encoding a given amino acid sequence, but not speci®cation for method of forming images using necessarily any particular species. Cf. In re Bell, photosensitive microcapsules which describes 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. removal of microcapsules from surface and warns Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 that capsules not be disturbed prior to formation of USPQ2d 1550, 1552 (Fed. Cir. 1994). If a image, unequivocally teaches absence of representative number of adequately described permanently ®xed microcapsules and supports species are not disclosed for a genus, the claim to amended language of claims requiring that that genus must be rejected as lacking adequate microcapsules be ªnot permanently ®xedº to written description under 35 U.S.C. 112(a) or underlying surface, and therefore meets description pre-AIA 35 U.S.C. 112, para. 1. requirement of 35 U.S.C. 112.); In re Robins, 429 F.2d 452, 456-57, 166 USPQ 552, 555 (CCPA 1970) (b) New Claims, Amended Claims, or Claims (ª[W]here no explicit description of a generic Asserting Entitlement to the Bene®t of an Earlier invention is to be found in the speci®cation[,] ... mention of representative compounds may provide an implicit description upon which to base generic claim language.º); In re Smith, 458 F.2d 1389, 1395,

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173 USPQ 679, 683 (CCPA 1972) (a subgenus is then should any rejection be imposed in an Of®ce not necessarily implicitly described by a genus action. The Of®ce action should clearly encompassing it and a species upon which it reads); communicate the ®ndings, conclusions, and reasons In re Robertson, 169 F.3d 743, 745, 49 USPQ2d which support them. When possible, the Of®ce 1949, 1950-51 (Fed. Cir. 1999) (ªTo establish action should offer helpful suggestions on how to inherency, the extrinsic evidence `must make clear overcome rejections. that the missing descriptive matter is necessarily present in the thing described in the reference, and A. For Each Claim Lacking Written Description that it would be so recognized by persons of ordinary Support, Reject the Claim Under 35 U.S.C. 112(a) or skill. Inherency, however, may not be established Pre-AIA 35 U.S.C. 112, para. 1, for Lack of Adequate by probabilities or possibilities. The mere fact that Written Description a certain thing may result from a given set of circumstances is not suf®cient.'º) (citations omitted). A description as ®led is presumed to be adequate, Furthermore, each claim must include all elements unless or until suf®cient evidence or reasoning to which applicant has described as essential. See, e.g., the contrary has been presented by the examiner to Johnson Worldwide Assoc. Inc. v. Zebco Corp., 175 rebut the presumption. See, e.g., In re Marzocchi, F.3d at 993, 50 USPQ2d at 1613; Gentry Gallery, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA Inc. v. Berkline Corp., 134 F.3d at 1479, 45 USPQ2d 1971). The examiner, therefore, must have a at 1503; Tronzo v. Biomet, 156 F.3d at 1159, reasonable basis to challenge the adequacy of the 47 USPQ2d at 1833. written description. The examiner has the initial burden of presenting by a preponderance of evidence If the originally ®led disclosure does not provide why a person skilled in the art would not recognize support for each claim limitation, or if an element in an applicant's disclosure a description of the which applicant describes as essential or critical is invention de®ned by the claims. Wertheim, 541 F.2d not claimed, a new or amended claim must be at 263, 191 USPQ at 97. In rejecting a claim, the rejected under 35 U.S.C. 112(a) or pre-AIA 35 examiner must set forth express ®ndings of fact U.S.C. 112, para. 1, as lacking adequate written regarding the above analysis which support the lack description, or in the case of a priority or bene®t of written description conclusion. These ®ndings claim under 35 U.S.C. 119, 120, 365, or 386, the should: priority or bene®t claim must be denied. (A) Identify the claim limitation at issue; and III. COMPLETE PATENTABILITY (B) Establish a prima facie case by providing DETERMINATION UNDER ALL STATUTORY reasons why a person skilled in the art at the time REQUIREMENTS AND CLEARLY the application was ®led would not have recognized COMMUNICATE FINDINGS, CONCLUSIONS, that the inventor was in possession of the invention AND THEIR BASES as claimed in view of the disclosure of the application as ®led. A general allegation of The above only describes how to determine whether ªunpredictability in the artº is not a suf®cient reason the written description requirement of 35 U.S.C. to support a rejection for lack of adequate written 112(a) or pre-AIA 35 U.S.C. 112, para. 1, is description. satis®ed. Regardless of the outcome of that determination, Of®ce personnel must complete the When appropriate, suggest amendments to the claims patentability determination under all the relevant which can be supported by the application's written statutory provisions of title 35 of the U.S. Code. description, being mindful of the prohibition against the addition of new matter in the claims or Once Of®ce personnel have concluded analysis of description. See Rasmussen, 650 F.2d at 1214, the claimed invention under all the statutory 211 USPQ at 326. provisions, including 35 U.S.C. 101, 112, 102, and 103, they should review all the proposed rejections B. Upon Reply by Applicant, Again Determine the and their bases to con®rm their correctness. Only Patentability of the Claimed Invention, Including Whether the Written Description Requirement Is

2100-247 Rev. 07.2015, October 2015 § 2163.01 MANUAL OF PATENT EXAMINING PROCEDURE

Satis®ed by Reperforming the Analysis Described Above and statutory basis for addressing these issues differ. in View of the Whole Record See MPEP § 2163.06.

Upon reply by applicant, before repeating any 2163.02 Standard for Determining rejection under 35 U.S.C. 112(a) or pre-AIA 35 Compliance With the Written Description U.S.C. 112, para. 1, for lack of written description, Requirement [R-11.2013] review the basis for the rejection in view of the record as a whole, including amendments, The courts have described the essential question to arguments, and any evidence submitted by applicant. be addressed in a description requirement issue in a If the whole record now demonstrates that the written variety of ways. An objective standard for description requirement is satis®ed, do not repeat determining compliance with the written description the rejection in the next Of®ce action. If the record requirement is, ªdoes the description clearly allow still does not demonstrate that the written description persons of ordinary skill in the art to recognize that is adequate to support the claim(s), repeat the he or she invented what is claimed.º In re Gosteli, rejection under 35 U.S.C. 112(a) or pre-AIA 35 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. U.S.C. 112, para. 1, fully respond to applicant's Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 rebuttal arguments, and properly treat any further F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. showings submitted by applicant in the reply. When Cir. 1991), to satisfy the written description a rejection is maintained, any af®davits relevant to requirement, an applicant must convey with the 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. reasonable clarity to those skilled in the art that, as 1, written description requirement, must be of the ®ling date sought, he or she was in possession thoroughly analyzed and discussed in the next Of®ce of the invention, and that the invention, in that action. See In re Alton, 76 F.3d 1168, 1176, 37 context, is whatever is now claimed. The test for USPQ2d 1578, 1584 (Fed. Cir. 1996). suf®ciency of support in a parent application is whether the disclosure of the application relied upon 2163.01 Support for the Claimed Subject ªreasonably conveys to the artisan that the inventor Matter in Disclosure [R-11.2013] had possession at that time of the later claimed subject matter.º Ralston Purina Co. v. Far-Mar-Co., A written description requirement issue generally Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. involves the question of whether the subject matter Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, of a claim is supported by [conforms to] the 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). disclosure of an application as ®led. If the examiner concludes that the claimed subject matter is not Whenever the issue arises, the fundamental factual supported [described] in an application as ®led, this inquiry is whether the speci®cation conveys with would result in a rejection of the claim on the ground reasonable clarity to those skilled in the art that, as of a lack of written description under 35 U.S.C. of the ®ling date sought, applicant was in possession 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, of the invention as now claimed. See, e.g., Vas-Cath, or denial of the bene®t of the ®ling date of a Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 previously ®led application. The claim should not USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant be rejected or objected to on the ground of new shows possession of the claimed invention by matter. As framed by the court in In re Rasmussen, describing the claimed invention with all of its 650 F.2d 1212, 211 USPQ 323 (CCPA 1981), the limitations using such descriptive means as words, concept of new matter is properly employed as a structures, ®gures, diagrams, and formulas that fully basis for objection to amendments to the abstract, set forth the claimed invention. Lockwood v. Am. speci®cation or drawings attempting to add new Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d disclosure to that originally presented. While the test 1961, 1966 (Fed. Cir. 1997). Possession may be or analysis of description requirement and new shown in a variety of ways including description of matter issues is the same, the examining procedure an actual reduction to practice, or by showing that the invention was ªready for patentingº such as by the disclosure of drawings or structural chemical

Rev. 07.2015, October 2015 2100-248 PATENTABILITY § 2163.03

formulas that show that the invention was complete, amendment to the speci®cation (e.g., a change in or by describing distinguishing identifying the de®nition of a term used both in the speci®cation characteristics suf®cient to show that the applicant and claim) may indirectly affect a claim even though was in possession of the claimed invention. See, e.g., no actual amendment is made to the claim. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents II. RELIANCE ON FILING DATE OF PARENT of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, APPLICATION UNDER 35 U.S.C. 120 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 Under 35 U.S.C. 120, the claims in a U.S. application USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must are entitled to the bene®t of the ®ling date of an de®ne a compound by ªwhatever characteristics earlier ®led U.S. application if the subject matter of suf®ciently distinguish itº). the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst The subject matter of the claim need not be described paragraph in the earlier ®led application. See, e.g., literally (i.e., using the same terms or in haec verba) Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d in order for the disclosure to satisfy the description 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, requirement. If a claim is amended to include subject 199 USPQ 782 (CCPA 1978). matter, limitations, or terminology not present in the application as ®led, involving a departure from, III. RELIANCE ON PRIORITY UNDER 35 U.S.C. addition to, or deletion from the disclosure of the 119 application as ®led, the examiner should conclude that the claimed subject matter is not described in Under 35 U.S.C. 119(a) or (e), the claims in a U.S. that application. This conclusion will result in the application are entitled to the bene®t of a foreign rejection of the claims affected under 35 U.S.C. priority date or the ®ling date of a provisional 112(a) or pre-AIA 35 U.S.C.112, ®rst paragraph - application if the corresponding foreign application description requirement, or denial of the bene®t of or provisional application supports the claims in the the ®ling date of a previously ®led application, as manner required by 35 U.S.C. 112(a) or pre-AIA 35 appropriate. U.S.C. 112, ®rst paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. See MPEP § 2163 for examination guidelines 1993); Kawai v. Metlesics, 480 F.2d 880, 178 pertaining to the written description requirement. USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). 2163.03 Typical Circumstances Where Adequate Written Description Issue Arises IV. SUPPORT FOR A CLAIM CORRESPONDING TO A COUNT IN AN INTERFERENCE [R-07.2015] In an interference proceeding, the claim A description requirement issue can arise in a corresponding to a count must be supported by the number of different circumstances where it must be speci®cation in the manner provided by 35 U.S.C. determined whether the subject matter of a claim is 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. supported in an application as ®led. See MPEP § Fields v. Conover, 443 F.2d 1386, 170 USPQ 276 2163 for examination guidelines pertaining to the (CCPA 1971) (A broad generic disclosure to a class written description requirement. Most typically, the of compounds was not a suf®cient written issue will arise in the following circumstances: description of a speci®c compound within the class.). Furthermore, when a party to an interference seeks I. AMENDMENT AFFECTING A CLAIM the bene®t of an earlier-®led U.S. patent application, the earlier application must meet the requirements An amendment to the claims or the addition of a new of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst claim must be supported by the description of the paragraph for the subject matter of the count. Hyatt invention in the application as ®led. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). An

2100-249 Rev. 07.2015, October 2015 § 2163.04 MANUAL OF PATENT EXAMINING PROCEDURE

v. Boone, 146 F.3d 1348, 1352, 47 USPQ2d 1128, paragraph. In re Donaldson Co., 16 F.3d 1189, 1130 (Fed. Cir. 1998). 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). Such a limitation also lacks an adequate V. ORIGINAL CLAIM NOT SUFFICIENTLY written description as required by 35 U.S.C. 112(a) DESCRIBED or pre-AIA 35 U.S.C. 112, ®rst paragraph because an inde®nite, unbounded functional limitation would While there is a presumption that an adequate written cover all ways of performing a function and indicate description of the claimed invention is present in the that the inventor has not provided suf®cient speci®cation as ®led, In re Wertheim, 541 F.2d 257, disclosure to show possession of the invention. 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a speci®cation provides an adequate 2163.04 Burden on the Examiner with written description may arise in the context of an Regard to the Written Description original claim. An original claim may lack written Requirement [R-11.2013] description support when (1) the claim de®nes the invention in functional language specifying a desired The inquiry into whether the description requirement result but the disclosure fails to suf®ciently identify is met must be determined on a case-by-case basis how the function is performed or the result is and is a question of fact. In re Wertheim, 541 F.2d achieved or (2) a broad genus claim is presented but 257, 262, 191 USPQ 90, 96 (CCPA 1976). A the disclosure only describes a narrow species with description as ®led is presumed to be adequate, no evidence that the genus is contemplated. See unless or until suf®cient evidence or reasoning to Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, the contrary has been presented by the examiner to 1349-50 (Fed. Cir. 2010) en banc. The written rebut the presumption. See, e.g., In re Marzocchi, description requirement is not necessarily met when 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA the claim language appears in ipsis verbis in the 1971). The examiner, therefore, must have a speci®cation. ªEven if a claim is supported by the reasonable basis to challenge the adequacy of the speci®cation, the language of the speci®cation, to written description. The examiner has the initial the extent possible, must describe the claimed burden of presenting by a preponderance of evidence invention so that one skilled in the art can recognize why a person skilled in the art would not recognize what is claimed. The appearance of mere indistinct in an applicant's disclosure a description of the words in a speci®cation or a claim, even an original invention de®ned by the claims. Wertheim, 541 F.2d claim, does not necessarily satisfy that at 263, 191 USPQ at 97. requirement.º Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 I. STATEMENT OF REJECTION REQUIREMENTS (Fed. Cir. 2002). In rejecting a claim, the examiner must set forth VI. INDEFINITENESS REJECTION OF A MEANS- (OR STEP-) PLUS-FUNCTION LIMITATION express ®ndings of fact which support the lack of written description conclusion (see MPEP § 2163 for examination guidelines pertaining to the written A claim limitation expressed in means- (or step-) description requirement). These ®ndings should: plus-function language ªshall be construed to cover the corresponding structure, material, or acts (A) Identify the claim limitation(s) at issue; and described in the speci®cation and equivalents thereof.º 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. (B) Establish a prima facie case by providing 112, sixth paragraph. If the speci®cation fails to reasons why a person skilled in the art at the time disclose suf®cient corresponding structure, materials, the application was ®led would not have recognized or acts that perform the entire claimed function, then that the inventor was in possession of the invention the claim limitation is inde®nite because the as claimed in view of the disclosure of the applicant has in effect failed to particularly point out application as ®led. A general allegation of and distinctly claim the invention as required by 35 ªunpredictability in the artº is not a suf®cient reason U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second to support a rejection for lack of adequate written description. A simple statement such as ªApplicant

Rev. 07.2015, October 2015 2100-250 PATENTABILITY § 2163.05

has not pointed out where the new (or amended) U.S.C. 112, ®rst paragraph, commonly arises when claim is supported, nor does there appear to be a the claims are changed after ®ling to either broaden written description of the claim limitation `____' in or narrow the breadth of the claim limitations, or to the application as ®led.º may be suf®cient where alter a numerical range limitation or to use claim the claim is a new or amended claim, the support for language which is not synonymous with the the limitation is not apparent, and applicant has not terminology used in the original disclosure. To pointed out where the limitation is supported. comply with the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 1, or to be entitled to an earlier priority date or ®ling USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that date under 35 U.S.C. 119, 120, or 365(c), each claim ª[MPEP] § 2163.04 [subsection] (I)(B) as written is limitation must be expressly, implicitly, or inherently a lawful formulation of the prima facie standard for supported in the originally ®led disclosure. See a lack of written description rejection.º). MPEP § 2163 for examination guidelines pertaining to the written description requirement. When appropriate, suggest amendments to the claims which can be supported by the application's written I. BROADENING CLAIM description, being mindful of the prohibition against the addition of new matter in the claims or A. Omission of a Limitation description. See Rasmussen, 650 F.2d at 1214, 211 USPQ at 326. Under certain circumstances, omission of a limitation can raise an issue regarding whether the inventor II. RESPONSE TO APPLICANT'S REPLY had possession of a broader, more generic invention. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., Upon reply by applicant, before repeating any 134 F.3d 1473, 45 USPQ2d 1498 (Fed. Cir. 1998) rejection under 35 U.S.C. 112(a) or pre-AIA 35 (claims to a sectional sofa comprising, inter alia, a U.S.C. 112, para. 1, for lack of written description, console and a control means were held invalid for review the basis for the rejection in view of the failing to satisfy the written description requirement record as a whole, including amendments, where the claims were broadened by removing the arguments, and any evidence submitted by applicant. location of the control means.); Johnson Worldwide If the whole record now demonstrates that the written Assoc. v. Zebco Corp., 175 F.3d 985, 993, description requirement is satis®ed, do not repeat 50 USPQ2d 1607, 1613 (Fed. Cir. 1999) (In Gentry the rejection in the next Of®ce action. If the record Gallery, the ªcourt's determination that the patent still does not demonstrate that the written description disclosure did not support a broad meaning for the is adequate to support the claim(s), repeat the disputed claim terms was premised on clear rejection under 35 U.S.C. 112(a) or pre-AIA 35 statements in the written description that described U.S.C. 112, para. 1, fully respond to applicant's the location of a claim element--the `control rebuttal arguments, and properly treat any further means'--as `the only possible location' and that showings submitted by applicant in the reply. When variations were `outside the stated purpose of the a rejection is maintained, any af®davits relevant to invention.' Gentry Gallery, 134 F.3d at 1479, 45 the 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. USPQ2d at 1503. Gentry Gallery, then, considers 1, written description requirement, must be the situation where the patent's disclosure makes thoroughly analyzed and discussed in the next Of®ce crystal clear that a particular (i.e., narrow) action. See In re Alton, 76 F.3d 1168, 1176, 37 understanding of a claim term is an `essential USPQ2d 1578, 1584 (Fed. Cir. 1996). element of [the inventor's] invention.'º); Tronzo v. Biomet, 156 F.3d at 1158-59, 47 USPQ2d at 1833 2163.05 Changes to the Scope of Claims (Fed. Cir. 1998) (claims to generic cup shape were [R-07.2015] not entitled to ®ling date of parent application which disclosed ªconical cupº in view of the disclosure of The failure to meet the written description the parent application stating the advantages and requirement of 35 U.S.C. 112(a) or pre-AIA 35 importance of the conical shape.); In re Wilder, 736

2100-251 Rev. 07.2015, October 2015 § 2163.05 MANUAL OF PATENT EXAMINING PROCEDURE

F.2d 1516, 222 USPQ 369 (Fed. Cir. 1984) (reissue describe a suf®cient variety of species to re¯ect the claim omitting ªin synchronismº limitation with variation within the genus. See AbbVie Deutschland respect to scanning means and indexing means was GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d not supported by the original patent's disclosure in 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. such a way as to indicate possession, as of the 2014) (Claims directed to a functionally de®ned original ®ling date, of that generic invention.). genus of antibodies were not supported by a disclosure that ªonly describe[d] one type of A claim that omits an element which applicant structurally similar antibodiesº that ªare not describes as an essential or critical feature of the representative of the full variety or scope of the invention originally disclosed does not comply with genus.º). The disclosure of only one species the written description requirement. See Gentry encompassed within a genus adequately describes a Gallery, 134 F.3d at 1480, 45 USPQ2d at 1503; In claim directed to that genus only if the disclosure re Sus, 306 F.2d 494, 504, 134 USPQ 301, 309 ªindicates that the patentee has invented species (CCPA 1962) (ª[O]ne skilled in this art would not suf®cient to constitute the gen[us].º See Enzo be taught by the written description of the invention Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. ªA in the speci®cation that any `aryl or substituted aryl patentee will not be deemed to have invented species radical' would be suitable for the purposes of the suf®cient to constitute the genus by virtue of having invention but rather that only certain aryl radicals disclosed a single species when ¼ the evidence and certain speci®cally substituted aryl radicals [i.e., indicates ordinary artisans could not predict the aryl azides] would be suitable for such purposes.º) operability in the invention of any species other than (emphasis in original). Compare In re Peters, 723 the one disclosed.º In re Curtis, 354 F.3d 1347, F.2d 891, 221 USPQ 952 (Fed. Cir. 1983) (In a 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) reissue application, a claim to a display device was (Claims directed to PTFE dental ¯oss with a broadened by removing the limitations directed to friction-enhancing coating were not supported by a the speci®c tapered shape of the tips without disclosure of a microcrystalline wax coating where violating the written description requirement. The there was no evidence in the disclosure or anywhere shape limitation was considered to be unnecessary else in the record showing applicant conveyed that since the speci®cation, as ®led, did not describe the any other coating was suitable for a PTFE dental tapered shape as essential or critical to the operation ¯oss.) On the other hand, there may be situations or patentability of the claim.). A claim which omits where one species adequately supports a genus. See, matter disclosed to be essential to the invention as e.g., In re Rasmussen, 650 F.2d 1212, 1214, 211 described in the speci®cation or in other statements USPQ 323, 326-27 (CCPA 1981) (disclosure of a of record may also be subject to rejection under 35 single method of adheringly applying one layer to U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, para. 1, as another was suf®cient to support a generic claim to not enabling, or under 35 U.S.C. 112(b) or pre-AIA ªadheringly applyingº because one skilled in the art 35 U.S.C. 112, para. 2. See In re Mayhew, 527 F.2d reading the speci®cation would understand that it is 1229, 188 USPQ 356 (CCPA 1976); In re Venezia, unimportant how the layers are adhered, so long as 530 F.2d 956, 189 USPQ 149 (CCPA 1976); and In they are adhered); In re Herschler, 591 F.2d 693, re Collier, 397 F.2d 1003, 158 USPQ 266 (CCPA 697, 200 USPQ 711, 714 (CCPA 1979) (disclosure 1968). See also MPEP § 2172.01. of corticosteriod in DMSO suf®cient to support claims drawn to a method of using a mixture of a B. Addition of Generic Claim ªphysiologically active steroidº and DMSO because ªuse of known chemical compounds in a manner The written description requirement for a claimed auxiliary to the invention must have a corresponding genus may be satis®ed through suf®cient description written description only so speci®c as to lead one of a representative number of species. A having ordinary skill in the art to that class of ªrepresentative number of speciesº means that the compounds. Occasionally, a functional recitation of species which are adequately described are those known compounds in the speci®cation may representative of the entire genus. Thus, when there be suf®cient as that description.º); In re Smythe, is substantial variation within the genus, one must 480 F.2d 1376, 1383, 178 USPQ 279, 285 (CCPA

Rev. 07.2015, October 2015 2100-252 PATENTABILITY § 2163.05

1973) (the phrase ªair or other gas which is inert to language possible during prosecution, cannot now the liquidº was suf®cient to support a claim to ªinert improperly narrow its language by importing ¯uid mediaº because the description of the properties limitations not supported by the claim language or and functions of the air or other gas segmentizing written description.º). In Ex parte Ohshiro, medium would suggest to a person skilled in the art 14 USPQ2d 1750 (Bd. Pat. App. & Inter. 1989), the that appellant's invention includes the use of ªinert Board af®rmed the rejection under 35 U.S.C. 112, ¯uidº broadly.). However, in Tronzo v. Biomet, 156 ®rst paragraph, of claims to an internal combustion F.3d 1154, 1159, 47 USPQ2d 1829, 1833 (Fed. Cir. engine which recited ªat least one of said piston and 1998), the disclosure of a species in the parent said cylinder (head) having a recessed channel.º The application did not suf®ce to provide written Board held that the application which disclosed a description support for the genus in the child cylinder head with a recessed channel and a piston application where the speci®cation taught against without a recessed channel did not speci®cally other species. See also In re Gosteli, 872 F.2d 1008, disclose the ªspeciesº of a channeled piston. 10 USPQ2d 1614 (Fed. Cir. 1989) (generic and subgeneric claims in the U.S. application were not While these and other cases ®nd that recitation of entitled to the bene®t of foreign priority where the an undisclosed species may violate the description foreign application disclosed only two of the requirement, a change involving subgeneric species encompassed by the broad generic claim and terminology may or may not be acceptable. the subgeneric Markush claim that encompassed 21 Applicant was not entitled to the bene®t of a parent compounds). ®ling date when the claim was directed to a subgenus (a speci®ed range of molecular weight ratios) where II. NARROWING OR SUBGENERIC CLAIM the parent application contained a generic disclosure and a speci®c example that fell within the recited The introduction of claim changes which involve range because the court held that subgenus range narrowing the claims by introducing elements or was not described in the parent application. In limitations which are not supported by the as-®led re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA disclosure is a violation of the written description 1971). On the other hand, in Ex parte Sorenson, 3 requirement of 35 U.S.C. 112(a) or pre-AIA 35 USPQ2d 1462 (Bd. Pat. App. & Inter. 1987), the U.S.C. 112, ®rst paragraph. See, e.g., Fujikawa v. subgeneric language of ªaliphatic carboxylic acidº Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, and ªaryl carboxylic acidº did not violate the written 1905 (Fed. Cir. 1996) (a ªlaundry listº disclosure of description requirement because species falling every possible moiety does not constitute a written within each subgenus were disclosed as well as the description of every species in a genus because it generic carboxylic acid. See also In re Smith, 458 would not ªreasonably leadº those skilled in the art F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) to any particular species); In re Ruschig, 379 F.2d (ªWhatever may be the viability of an 990, 995, 154 USPQ 118, 123 (CCPA 1967) (ª If inductive-deductive approach to arriving at a claimed n-propylamine had been used in making the subgenus, it cannot be said that such a subgenus is compound instead of n-butylamine, the compound necessarily described by a genus encompassing it of claim 13 would have resulted. Appellants submit and a species upon which it reads.º (emphasis to us, as they did to the board, an imaginary speci®c added)). Each case must be decided on its own facts example patterned on speci®c example 6 by which in terms of what is reasonably communicated to the above butyl compound is made so that we can those skilled in the art. In re Wilder, 736 F.2d 1516, see what a simple change would have resulted in a 1520, 222 USPQ 369, 372 (Fed. Cir. 1984). speci®c supporting disclosure being present in the present speci®cation. The trouble is that there is no III. RANGE LIMITATIONS such disclosure, easy though it is to imagine it.º) (emphasis in original); Rozbicki v. Chiang, 590 With respect to changing numerical range Fed.App'x 990, 996 (Fed. Cir. 2014) limitations, the analysis must take into account which (non-precedential) (The court found that patentee, ranges one skilled in the art would consider ªwhile attempting to obtain the broadest claim inherently supported by the discussion in the original

2100-253 Rev. 07.2015, October 2015 § 2163.06 MANUAL OF PATENT EXAMINING PROCEDURE

disclosure. In the decision in In re Wertheim, 541 part of the application without introducing new F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges matter. described in the original speci®cation included a range of ª25%- 60%º and speci®c examples of There are two statutory provisions that prohibit the ª36%º and ª50%.º A corresponding new claim introduction of new matter. The ®rst provision is 35 limitation to ªat least 35%º did not meet the U.S.C. 132, which provides that no amendment shall description requirement because the phrase ªat leastº introduce new matter into the disclosure of the had no upper limit and caused the claim to read invention. The second provision is 35 U.S.C. 251, literally on embodiments outside the ª25% to 60%º which provides that no new matter shall be range, however a limitation to ªbetween 35% and introduced into the application for reissue. 60%º did meet the description requirement. I. TREATMENT OF NEW MATTER See also Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 If new subject matter is added to the disclosure, (Fed. Cir. 2000) (ª[T]he speci®cation does not whether it be in the abstract, the speci®cation, or the clearly disclose to the skilled artisan that the drawings, the examiner should object to the inventors... considered the... ratio to be part of their introduction of new matter under 35 U.S.C. 132 or invention.... There is therefore no force to Purdue's 251 as appropriate, and require applicant to cancel argument that the written description requirement the new matter. If new matter is added to the claims, was satis®ed because the disclosure revealed a broad the examiner should reject the claims under 35 invention from which the [later-®led] claims carved U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst out a patentable portionº). Compare Union Oil of paragraph - written description requirement. In re Cal. v. Atl. Rich®eld Co., 208 F.3d 989, 997, 54 Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA USPQ2d 1227, 1232-33 (Fed. Cir. 2000) 1981). The examiner should still consider the subject (Description in terms of ranges of chemical matter added to the claim in making rejections based properties which work in combination with ranges on prior art since the new matter rejection may be of other chemical properties to produce an overcome by applicant. automotive gasoline that reduces emissions was found to provide an adequate written description When the claims have not been amended, per se, even though the exact chemical components of each but the speci®cation has been amended to add new combination were not disclosed and the speci®cation matter, a rejection of the claims under 35 U.S.C. did not disclose any distinct embodiments 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, corresponding to any claim at issue. ª[T]he Patent should be made whenever any of the claim Act and this court's case law require only suf®cient limitations are affected by the added material. description to show one of skill in the . . . art that the inventor possessed the claimed invention at the When an amendment is ®led in reply to an objection time of ®ling.º). or rejection based on 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, a study of the entire 2163.06 Relationship of Written Description application is often necessary to determine whether Requirement to New Matter [R-11.2013] or not ªnew matterº is involved. Applicant should therefore speci®cally point out the support for any Lack of written description is an issue that generally amendments made to the disclosure. arises with respect to the subject matter of a claim. If an applicant amends or attempts to amend the II. REVIEW OF NEW MATTER OBJECTIONS abstract, speci®cation or drawings of an application, AND/OR REJECTIONS an issue of new matter will arise if the content of the amendment is not described in the application as A rejection of claims is reviewable by the Patent ®led. Stated another way, information contained in Trial and Appeal Board, whereas an objection and any one of the speci®cation, claims or drawings of requirement to delete new matter is subject to the application as ®led may be added to any other supervisory review by petition under 37 CFR 1.181.

Rev. 07.2015, October 2015 2100-254 PATENTABILITY § 2163.07

If both the claims and speci®cation contain new polypeptide and since the committee found that matter either directly or indirectly, and there has leukocytes also produced other types of interferon. been both a rejection and objection by the examiner, The court held that the subsequent amendment to the issue becomes appealable and should not be the speci®cation and claims substituting the term decided by petition. ªIFN-(a)º for ªleukocyte interferonº merely renamed the invention and did not constitute new matter. The III. CLAIMED SUBJECT MATTER NOT claims were limited to cover only the interferon DISCLOSED IN REMAINDER OF SPECIFICATION subtype coded for by the inventor's original deposits.

The claims as ®led in the original speci®cation are II. OBVIOUS ERRORS part of the disclosure and therefore, if an application as originally ®led contains a claim disclosing An amendment to correct an obvious error does not material not disclosed in the remainder of the constitute new matter where one skilled in the art speci®cation, the applicant may amend the would not only recognize the existence of error in speci®cation to include the claimed subject matter. the speci®cation, but also the appropriate correction. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. In re Odd, 443 F.2d 1200, 170 USPQ 268 (CCPA Cir. 1985). Form paragraph 7.44 may be used where 1971). originally claimed subject matter lacks proper antecedent basis in the speci®cation. See MPEP § Where a foreign priority document under 35 U.S.C. 608.01(o). 119 is of record in the U.S. application ®le, applicant may not rely on the disclosure of that document to 2163.07 Amendments to Application Which support correction of an error in the pending U.S. Are Supported in the Original Description application. Ex parte Bondiou, 132 USPQ 356 (Bd. [R-08.2012] App. 1961). This prohibition applies regardless of the language of the foreign priority documents Amendments to an application which are supported because a claim for priority is simply a claim for the in the original description are NOT new matter. bene®t of an earlier ®ling date for subject matter that is common to two or more applications, and I. REPHRASING does not serve to incorporate the content of the priority document in the application in which the Mere rephrasing of a passage does not constitute claim for priority is made. This prohibition does not new matter. Accordingly, a rewording of a apply where the U.S. application explicitly passage where the same meaning remains intact is incorporates the foreign priority document by permissible. In re Anderson, 471 F.2d 1237, reference. For applications ®led on or after 176 USPQ 331 (CCPA 1973). The mere inclusion September 21, 2004, where all or a portion of the of dictionary or art recognized de®nitions known at speci®cation or drawing(s) is inadvertently omitted the time of ®ling an application may not be from the U.S. application, a claim under 37 CFR considered new matter. If there are multiple 1.55 for priority of a prior-®led foreign application de®nitions for a term and a de®nition is added to the that is present on the ®ling date of the application is application, it must be clear from the application as considered an incorporation by reference of the ®led that applicant intended a particular de®nition, prior-®led foreign application as to the inadvertently in order to avoid an issue of new matter and/or lack omitted portion of the speci®cation or drawing(s), of written description. See, e.g., Scarring Corp. v. subject to the conditions and requirements of 37 CFR Megan, Inc., 222 F.3d 1347, 1352-53, 55 USPQ2d 1.57(a). See 37 CFR 1.57(a) and MPEP § 217 . 1650, 1654 (Fed. Cir. 2000). In Scarring, the original disclosure was drawn to recombinant DNA Where a U.S. application as originally ®led was in molecules and used the term ªleukocyte interferon.º a non-English language and an English translation Shortly after the ®ling date, a scienti®c committee thereof was subsequently submitted pursuant to abolished the term in favor of ªIFN-(a),º since the 37 CFR 1.52(d), if there is an error in the English latter term more speci®cally identi®ed a particular translation, applicant may rely on the disclosure of

2100-255 Rev. 07.2015, October 2015 § 2163.07(a) MANUAL OF PATENT EXAMINING PROCEDURE

the originally ®led non-English language U.S. when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, application to support correction of an error in the sixth paragraph is invoked. English translation document. 2164 The Enablement Requirement 2163.07(a) Inherent Function, Theory, or [R-11.2013] Advantage [R-08.2012] The enablement requirement refers to the By disclosing in a patent application a device that requirement of 35 U.S.C. 112(a) or pre-AIA 35 inherently performs a function or has a property, U.S.C. 112, ®rst paragraph that the speci®cation operates according to a theory or has an advantage, describe how to make and how to use the invention. a patent application necessarily discloses that The invention that one skilled in the art must be function, theory or advantage, even though it says enabled to make and use is that de®ned by the nothing explicit concerning it. The application may claim(s) of the particular application or patent. later be amended to recite the function, theory or advantage without introducing prohibited new The purpose of the requirement that the speci®cation matter. In re Reynolds, 443 F.2d 384, 170 USPQ describe the invention in such terms that one skilled 94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178 in the art can make and use the claimed invention is USPQ 279 (CCPA 1973). ªTo establish inherency, to ensure that the invention is communicated to the the extrinsic evidence `must make clear that the interested public in a meaningful way. The missing descriptive matter is necessarily present in information contained in the disclosure of an the thing described in the reference, and that it would application must be suf®cient to inform those skilled be so recognized by persons of ordinary skill. in the relevant art how to both make and use the Inherency, however, may not be established by claimed invention. However, to comply with 35 probabilities or possibilities. The mere fact that a U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst certain thing may result from a given set of paragraph, it is not necessary to ªenable one of circumstances is not suf®cient.'º In re Robertson, ordinary skill in the art to make and use a perfected, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. commercially viable embodiment absent a claim Cir. 1999) (citations omitted). limitation to that effect.º CFMT, Inc. v. Yieldup Int'l Corp., 349 F.3d 1333, 1338, 68 USPQ2d 1940, 1944 2163.07(b) Incorporation by Reference (Fed. Cir. 2003) (an invention directed to a general [R-11.2013] system to improve the cleaning process for semiconductor wafers was enabled by a disclosure Instead of repeating some information contained in showing improvements in the overall system). another document, an application may attempt to Detailed procedures for making and using the incorporate the content of another document or part invention may not be necessary if the description of thereof by reference to the document in the text of the invention itself is suf®cient to permit those the speci®cation. The information incorporated is skilled in the art to make and use the invention. A as much a part of the application as ®led as if the patent claim is invalid if it is not supported by an text was repeated in the application, and should be enabling disclosure. treated as part of the text of the application as ®led. Replacing the identi®ed material incorporated by The enablement requirement of 35 U.S.C. 112(a) or reference with the actual text is not new matter. See pre-AIA 35 U.S.C. 112, ®rst paragraph, is separate 37 CFR 1.57 and MPEP § 608.01(p) for Of®ce and distinct from the written description requirement. policy regarding incorporation by reference. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, MPEP § 2181 for the impact of incorporation by 19 USPQ2d 1111, 1116-17 (Fed. Cir. 1991) (ªthe reference on the determination of whether applicant purpose of the `written description' requirement is has complied with the requirements of 35 U.S.C. broader than to merely explain how to `make and 112(b) or pre-AIA 35 U.S.C. 112, second paragraph use'º). See also MPEP § 2161. Therefore, the fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally

Rev. 07.2015, October 2015 2100-256 PATENTABILITY § 2164.01(a)

®led does not necessarily mean that the limitation reasonably skilled in the art could make or use the is also not enabled. In other words, even if a new invention from the disclosures in the patent coupled limitation is not described in the original disclosure, with information known in the art without undue the addition of a new limitation in and of itself may experimentation.º). A patent need not teach, and not create an enablement problem provided that one preferably omits, what is well known in the art. In skilled in the art could make and use the claimed re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, invention with the new limitation. Consequently, 1332 (Fed. Cir. 1991); Hybritech, Inc. v. such limitations must be analyzed for both Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, enablement and description using their separate and 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, distinct criteria. 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Furthermore, when the limitation is not described in Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, the speci®cation portion of the application as ®led 489 (Fed. Cir. 1984). Any part of the speci®cation but is in the claims, the limitation in and of itself can support an enabling disclosure, even a may enable one skilled in the art to make and use background section that discusses, or even the claimed invention. When claimed subject matter disparages, the subject matter disclosed therein. is only presented in the claims and not in the Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361, speci®cation portion of the application, the 77 USPQ2d 1041 (Fed. Cir. 2005)(discussion of speci®cation should be objected to for lacking the problems with a prior art feature does not mean that requisite support for the claimed subject matter using one of ordinary skill in the art would not know how form paragraph 7.44. See MPEP § 2163.06. This is to make and use this feature). Determining an objection to the speci®cation only and enablement enablement is a question of law based on underlying issues should be treated separately. factual ®ndings. In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991); Atlas Powder 2164.01 Test of Enablement [R-08.2012] Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). Any analysis of whether a particular claim is supported by the disclosure in an application requires UNDUE EXPERIMENTATION a determination of whether that disclosure, when ®led, contained suf®cient information regarding the The fact that experimentation may be complex does subject matter of the claims as to enable one skilled not necessarily make it undue, if the art typically in the pertinent art to make and use the claimed engages in such experimentation. In re Certain invention. The standard for determining whether the Limited-Charge Cell Culture Microcarriers, 221 speci®cation meets the enablement requirement was USPQ 1165, 1174 (Int'l Trade Comm©n 1983), cast in the Supreme Court decision of Mineral aff'd. sub nom., Massachusetts Institute of Separation v. Hyde, 242 U.S. 261, 270 (1916) which Technology v. A.B. Fortia, 774 F.2d 1104, 227 postured the question: is the experimentation needed USPQ 428 (Fed. Cir. 1985). See also In re Wands, to practice the invention undue or unreasonable? 858 F.2d at 737, 8 USPQ2d at 1404. The test of That standard is still the one to be applied. In re enablement is not whether any experimentation is Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 necessary, but whether, if experimentation is (Fed. Cir. 1988). Accordingly, even though the necessary, it is undue. In re Angstadt, 537 F.2d 498, statute does not use the term ªundue 504, 190 USPQ 214, 219 (CCPA 1976). experimentation,º it has been interpreted to require that the claimed invention be enabled so that any 2164.01(a) Undue Experimentation Factors person skilled in the art can make and use the [R-08.2012] invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. There are many factors to be considered when Cir. 1988). See also United States v. Telectronics, determining whether there is suf®cient evidence to Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. support a determination that a disclosure does not Cir. 1988) (ªThe test of enablement is whether one satisfy the enablement requirement and whether any

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necessary experimentation is ªundue.º These factors A conclusion of lack of enablement means that, include, but are not limited to: based on the evidence regarding each of the above factors, the speci®cation, at the time the application (A) The breadth of the claims; was ®led, would not have taught one skilled in the (B) The nature of the invention; art how to make and/or use the full scope of the claimed invention without undue experimentation. (C) The state of the prior art; In re Wright, 999 F.2d 1557,1562, 27 USPQ2d (D) The level of one of ordinary skill; 1510, 1513 (Fed. Cir. 1993). (E) The level of predictability in the art; The determination that ªundue experimentationº (F) The amount of direction provided by the would have been needed to make and use the claimed inventor; invention is not a single, simple factual (G) The existence of working examples; and determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (H) The quantity of experimentation needed to In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404. make or use the invention based on the content of These factual considerations are discussed more fully the disclosure. in MPEP § 2164.08 (scope or breadth of the claims), In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, § 2164.05(a) (nature of the invention and state of 1404 (Fed. Cir. 1988) (reversing the PTO's the prior art), § 2164.05(b) (level of one of ordinary determination that claims directed to methods for skill), § 2164.03 (level of predictability in the art detection of hepatitis B surface antigens did not and amount of direction provided by the inventor), satisfy the enablement requirement). In Wands, the § 2164.02 (the existence of working examples) and court noted that there was no disagreement as to the § 2164.06 (quantity of experimentation needed to facts, but merely a disagreement as to the make or use the invention based on the content of interpretation of the data and the conclusion to be the disclosure). made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The Court held that 2164.01(b) How to Make the Claimed the speci®cation was enabling with respect to the Invention [R-08.2012] claims at issue and found that ªthere was considerable direction and guidanceº in the As long as the speci®cation discloses at least one speci®cation; there was ªa high level of skill in the method for making and using the claimed invention art at the time the application was ®led;º and ªall of that bears a reasonable correlation to the entire scope the methods needed to practice the invention were of the claim, then the enablement requirement of well known.º 858 F.2d at 740, 8 USPQ2d at 1406. 35 U.S.C. 112 is satis®ed. In re Fisher, 427 F.2d After considering all the factors related to the 833, 839, 166 USPQ 18, 24 (CCPA 1970). Failure enablement issue, the court concluded that ªit would to disclose other methods by which the claimed not require undue experimentation to obtain invention may be made does not render a claim antibodies needed to practice the claimed invention.º invalid under 35 U.S.C. 112. Spectra-Physics, Inc. Id., 8 USPQ2d at 1407. v. Coherent, Inc., 827 F.2d 1524, 1533, 3 USPQ2d 1737, 1743 (Fed. Cir. 1987), cert. denied, 484 U.S. It is improper to conclude that a disclosure is not 954 (1987). enabling based on an analysis of only one of the above factors while ignoring one or more of the Naturally, for unstable and transitory chemical others. The examiner's analysis must consider all intermediates, the ªhow to makeº requirement does the evidence related to each of these factors, and any not require that the applicant teach how to make the conclusion of nonenablement must be based on the claimed product in stable, permanent or isolatable evidence as a whole. 858 F.2d at 737, 740, 8 form. In re Breslow, 616 F.2d 516, 521, 205 USPQ USPQ2d at 1404, 1407. 221, 226 (CCPA 1980).

Rev. 07.2015, October 2015 2100-258 PATENTABILITY § 2164.02

A key issue that can arise when determining whether of being expressed in any cyanobacterium and thus the speci®cation is enabling is whether the starting de®ning the claimed gene by its use). materials or apparatus necessary to make the invention are available. In the biotechnical area, this In contrast, when a compound or composition claim is often true when the product or process requires a is not limited by a recited use, any enabled use that particular strain of microorganism and when the would reasonably correlate with the entire scope of microorganism is available only after extensive that claim is suf®cient to preclude a rejection for screening. nonenablement based on how to use. If multiple uses for claimed compounds or compositions are The court in In re Ghiron, 442 F.2d 985, 991, 169 disclosed in the application, then an enablement USPQ 723, 727 (CCPA 1971), made clear that if the rejection must include an explanation, suf®ciently practice of a method requires a particular apparatus, supported by the evidence, why the speci®cation the application must provide a suf®cient disclosure fails to enable each disclosed use. In other words, if of the apparatus if the apparatus is not readily any use is enabled when multiple uses are disclosed, available. The same can be said if certain chemicals the application is enabling for the claimed invention. are required to make a compound or practice a chemical process. In re Howarth, 654 F.2d 103, 2164.02 Working Example [R-11.2013] 105, 210 USPQ 689, 691 (CCPA 1981). Compliance with the enablement requirement of 35 2164.01(c) How to Use the Claimed Invention U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst [R-11.2013] paragraph, does not turn on whether an example is disclosed. An example may be ªworkingº or If a statement of utility in the speci®cation contains ªprophetic.º A working example is based on work within it a connotation of how to use, and/or the art actually performed. A prophetic example describes recognizes that standard modes of administration an embodiment of the invention based on predicted are known and contemplated, 35 U.S.C. 112 is results rather than work actually conducted or results satis®ed. In re Johnson, 282 F.2d 370, 373, 127 actually achieved. USPQ 216, 219 (CCPA 1960); In re Hitchings, 342 F.2d 80, 87, 144 USPQ 637, 643 (CCPA 1965). See An applicant need not have actually reduced the also In re Brana, 51 F.2d 1560, 1566, 34 USPQ2d invention to practice prior to ®ling. In Gould v. 1437, 1441 (Fed. Cir. 1993). Quigg, 822 F.2d 1074, 1078, 3 USPQ 2d 1302, 1304 (Fed. Cir. 1987), as of Gould's ®ling date, no person For example, it is not necessary to specify the dosage had built a light ampli®er or measured a population or method of use if it is known to one skilled in the inversion in a gas discharge. The court held that ªThe art that such information could be obtained without mere fact that something has not previously been undue experimentation. If one skilled in the art, done clearly is not, in itself, a suf®cient basis for based on knowledge of compounds having similar rejecting all applications purporting to disclose how physiological or biological activity, would be able to do it.º 822 F.2d at 1078, 3 USPQ2d at 1304 to discern an appropriate dosage or method of use (quoting In re Chilowsky, 229 F.2d 457, 461, 108 without undue experimentation, this would be USPQ 321, 325 (CCPA 1956)). suf®cient to satisfy 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. The applicant need not The speci®cation need not contain an example if the demonstrate that the invention is completely safe. invention is otherwise disclosed in such manner that See also MPEP § 2107.01 and § 2107.03. one skilled in the art will be able to practice it without an undue amount of experimentation. In When a compound or composition claim is limited re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, by a particular use, enablement of that claim should 645 (CCPA 1970). be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 Lack of a working example, however, is a factor to (Fed. Cir. 1991) (claiming a chimeric gene capable be considered, especially in a case involving an

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unpredictable and undeveloped art. But because only evidence, the examiner must weigh the evidence for an enabling disclosure is required, applicant need and against correlation and decide whether one not describe all actual embodiments. skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, I. NONE OR ONE WORKING EXAMPLE 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing the PTO decision based on When considering the factors relating to a ®nding that in vitro data did not support in vivo determination of non-enablement, if all the other applications). factors point toward enablement, then the absence of working examples will not by itself render the Since the initial burden is on the examiner to give invention non-enabled. In other words, lack of reasons for the lack of enablement, the examiner working examples or lack of evidence that the must also give reasons for a conclusion of lack of claimed invention works as described should never correlation for an in vitro or in vivo animal model be the sole reason for rejecting the claimed invention example. A rigorous or an invariable exact on the grounds of lack of enablement. A single correlation is not required, as stated in Cross v. working example in the speci®cation for a claimed Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747 invention is enough to preclude a rejection which (Fed. Cir. 1985): states that nothing is enabled since at least that embodiment would be enabled. However, a rejection [B]ased upon the relevant evidence as a whole, stating that enablement is limited to a particular there is a reasonable correlation between the scope may be appropriate. disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is The presence of only one working example should not necessary where the disclosure of never be the sole reason for rejecting claims as being pharmacological activity is reasonable based broader than the enabling disclosure, even though it upon the probative evidence. (Citations is a factor to be considered along with all the other omitted.) factors. To make a valid rejection, one must evaluate all the facts and evidence and state why one would III. WORKING EXAMPLES AND A CLAIMED not expect to be able to extrapolate that one example GENUS across the entire scope of the claims. For a claimed genus, representative examples II. CORRELATION: IN VITRO/ IN VIVO together with a statement applicable to the genus as a whole will ordinarily be suf®cient if one skilled The issue of ªcorrelationº is related to the issue of in the art (in view of level of skill, state of the art the presence or absence of working examples. and the information in the speci®cation) would ªCorrelationº as used herein refers to the relationship expect the claimed genus could be used in that between in vitro or in vivo animal model assays manner without undue experimentation. Proof of and a disclosed or a claimed method of use. An in enablement will be required for other members of vitro or in vivo animal model example in the the claimed genus only where adequate reasons are speci®cation, in effect, constitutes a ªworking advanced by the examiner to establish that a person exampleº if that example ªcorrelatesº with a skilled in the art could not use the genus as a whole disclosed or claimed method invention. If there is without undue experimentation. no correlation, then the examples do not constitute ªworking examples.º In this regard, the issue of 2164.03 Relationship of Predictability of the ªcorrelationº is also dependent on the state of the prior art. In other words, if the art is such that a Art and the Enablement Requirement particular model is recognized as correlating to a [R-08.2012] speci®c condition, then it should be accepted as correlating unless the examiner has evidence that The amount of guidance or direction needed to the model does not correlate. Even with such enable the invention is inversely related to the

Rev. 07.2015, October 2015 2100-260 PATENTABILITY § 2164.04

amount of knowledge in the state of the art as well on its face, contrary to generally accepted as the predictability in the art. In re Fisher, 427 F.2d scienti®c principles. Most often, additional 833, 839, 166 USPQ 18, 24 (CCPA 1970). The factors, such as the teachings in pertinent ªamount of guidance or directionº refers to that references, will be available to substantiate any information in the application, as originally ®led, doubts that the asserted scope of objective that teaches exactly how to make or use the enablement is in fact commensurate with the invention. The more that is known in the prior art scope of protection sought and to support any about the nature of the invention, how to make, and demands based thereon for proof. [Footnote how to use the invention, and the more predictable omitted.] the art is, the less information needs to be explicitly stated in the speci®cation. In contrast, if little is The scope of the required enablement varies known in the prior art about the nature of the inversely with the degree of predictability involved, invention and the art is unpredictable, the but even in unpredictable arts, a disclosure of every speci®cation would need more detail as to how to operable species is not required. A single make and use the invention in order to be enabling. embodiment may provide broad enablement in cases See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d involving predictable factors, such as mechanical or 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) electrical elements. In re Vickers, 141 F.2d 522, (ªNascent technology, however, must be enabled 526-27, 61 USPQ 122, 127 (CCPA 1944); In with a `speci®c and useful teaching.' The law re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 requires an enabling disclosure for nascent (CCPA 1971). However, in applications directed to technology because a person of ordinary skill in the inventions in arts where the results are unpredictable, art has little or no knowledge independent from the the disclosure of a single species usually does not patentee's instruction. Thus, the public's end of the provide an adequate basis to support generic claims. bargain struck by the patent system is a full enabling In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 disclosure of the claimed technology.º (citations (CCPA 1938). In cases involving unpredictable omitted)). factors, such as most chemical reactions and physiological activity, more may be required. In The ªpredictability or lack thereofº in the art refers re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 to the ability of one skilled in the art to extrapolate (CCPA 1970) (contrasting mechanical and electrical the disclosed or known results to the claimed elements with chemical reactions and physiological invention. If one skilled in the art can readily activity). See also In re Wright, 999 F.2d 1557, anticipate the effect of a change within the subject 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In matter to which the claimed invention pertains, then re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 there is predictability in the art. On the other hand, (Fed. Cir. 1991). This is because it is not reasonably if one skilled in the art cannot readily anticipate the predictable from the disclosure of one species, what effect of a change within the subject matter to which other species will work. that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of 2164.04 Burden on the Examiner Under the predictability. In particular, the court in In re Enablement Requirement [R-11.2013] Marzocchi, 439 F.2d 220, 223-24, 169 USPQ 367, 369-70 (CCPA 1971), stated: Before any analysis of enablement can occur, it is necessary for the examiner to construe the claims. For terms that are not well-known in the art, or for [I]n the ®eld of chemistry generally, there may terms that could have more than one meaning, it is be times when the well-known unpredictability necessary that the examiner select the de®nition that of chemical reactions will alone be enough to he/she intends to use when examining the create a reasonable doubt as to the accuracy of application, based on his/her understanding of what a particular broad statement put forward as applicant intends it to mean, and explicitly set forth enabling support for a claim. This will the meaning of the term and the scope of the claim especially be the case where the statement is,

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when writing an Of®ce action. See Genentech v. requirement to the utility requirement of 35 U.S.C. Wellcome Foundation, 29 F.3d 1555, 1563-64, 31 101). USPQ2d 1161, 1167-68 (Fed. Cir. 1994). While the analysis and conclusion of a lack of In order to make a rejection, the examiner has the enablement are based on the factors discussed in initial burden to establish a reasonable basis to MPEP § 2164.01(a) and the evidence as a whole, it question the enablement provided for the claimed is not necessary to discuss each factor in the invention. In re Wright, 999 F.2d 1557, 1562, 27 enablement rejection. Instead, the explanation of the USPQ2d 1510, 1513 (Fed. Cir. 1993) (examiner rejection should focus on those factors, reasons, and must provide a reasonable explanation as to why the evidence that lead the examiner to conclude e.g., scope of protection provided by a claim is not that the speci®cation fails to teach how to make and adequately enabled by the disclosure). A use the claimed invention without undue speci®cation disclosure which contains a teaching experimentation, or that the scope of any enablement of the manner and process of making and using an provided to one skilled in the art is not invention in terms which correspond in scope to commensurate with the scope of protection sought those used in describing and de®ning the subject by the claims. This can be done by making speci®c matter sought to be patented must be taken as being ®ndings of fact, supported by the evidence, and then in compliance with the enablement requirement of drawing conclusions based on these ®ndings of fact. 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst For example, doubt may arise about enablement paragraph, unless there is a reason to doubt the because information is missing about one or more objective truth of the statements contained therein essential parts or relationships between parts which which must be relied on for enabling support. one skilled in the art could not develop without Assuming that suf®cient reason for such doubt undue experimentation. In such a case, the examiner exists, a rejection for failure to teach how to make should speci®cally identify what information is and/or use will be proper on that basis. In missing and why one skilled in the art could not re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, supply the information without undue 370 (CCPA 1971). As stated by the court, ªit is experimentation. See MPEP § 2164.06(a). incumbent upon the Patent Of®ce, whenever a References should be supplied if possible to support rejection on this basis is made, to explain why it a prima facie case of lack of enablement, but are doubts the truth or accuracy of any statement in a not always required. In re Marzocchi, 439 F.2d 220, supporting disclosure and to back up assertions of 224, 169 USPQ 367, 370 (CCPA 1971). However, its own with acceptable evidence or reasoning which speci®c technical reasons are always required. is inconsistent with the contested statement. Otherwise, there would be no need for the applicant In accordance with the principles of compact to go to the trouble and expense of supporting his prosecution, if an enablement rejection is presumptively accurate disclosure.º 439 F.2d at 224, appropriate, the ®rst Of®ce action on the merits 169 USPQ at 370 (emphasis in original). should present the best case with all the relevant reasons, issues, and evidence so that all such According to In re Bowen, 492 F.2d 859, 862-63, rejections can be withdrawn if applicant provides 181 USPQ 48, 51 (CCPA 1974), the minimal appropriate convincing arguments and/or evidence requirement is for the examiner to give reasons in rebuttal. Providing the best rejection in the ®rst explaining the uncertainty of the enablement. This Of®ce action will also allow the second Of®ce action standard is applicable even when there is no evidence to be made ®nal should applicant fail to provide in the record of operability without undue appropriate convincing arguments and/or evidence. experimentation beyond the disclosed embodiments. Citing new references and/or expanding arguments See also In re Brana, 51 F.3d 1560, 1566, 34 in a second Of®ce action could prevent that Of®ce USPQ2d 1436, 1441 (Fed. Cir. 1995) (citing In action from being made ®nal. The principles of re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 compact prosecution also dictate that if an (CCPA 1981)) (discussed in MPEP § 2164.07 enablement rejection is appropriate and the examiner regarding the relationship of the enablement recognizes limitations that would render the claims

Rev. 07.2015, October 2015 2100-262 PATENTABILITY § 2164.05(a)

enabled, the examiner should note such limitations 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994) to applicant as early in the prosecution as possible. (ªTesting for full safety and effectiveness of a prosthetic device is more properly left to the In other words, the examiner should always look for [FDA].º). Once that evidence is submitted, it must enabled, allowable subject matter and communicate be weighed with all other evidence according to the to applicant what that subject matter is at the earliest standards set forth above so as to reach a point possible in the prosecution of the application. determination as to whether the disclosure enables the claimed invention. 2164.05 Determination of Enablement Based on Evidence as a Whole [R-08.2012] To overcome a prima facie case of lack of enablement, applicant must demonstrate by argument Once the examiner has weighed all the evidence and and/or evidence that the disclosure, as ®led, would established a reasonable basis to question the have enabled the claimed invention for one skilled enablement provided for the claimed invention, the in the art at the time of ®ling. This does not preclude burden falls on applicant to present persuasive applicant from providing a declaration after the ®ling arguments, supported by suitable proofs where date which demonstrates that the claimed invention necessary, that one skilled in the art would be able works. However, the examiner should carefully to make and use the claimed invention using the compare the steps, materials, and conditions used in application as a guide. In re Brandstadter, 484 F.2d the experiments of the declaration with those 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973). disclosed in the application to make sure that they The evidence provided by applicant need not be are commensurate in scope; i.e., that the experiments conclusive but merely convincing to one skilled in used the guidance in the speci®cation as ®led and the art. what was well known to one of skill in the art at the time of ®ling. Such a showing also must be commensurate with the scope of the claimed Applicant may submit factual af®davits under 37 invention, i.e., must reasonably enable the full scope CFR 1.132 or cite references to show what one of the claimed invention. skilled in the art knew at the time of ®ling the application. A declaration or af®davit is, itself, evidence that must be considered. The weight to give The examiner must then weigh all the evidence a declaration or af®davit will depend upon the before him or her, including the speci®cation, any amount of factual evidence the declaration or new evidence supplied by applicant, and any af®davit contains to support the conclusion of evidence and scienti®c reasoning previously enablement. In re Buchner, 929 F.2d 660, 661, 18 presented in the rejection and then decide whether USPQ2d 1331, 1332 (Fed. Cir. 1991) (ªexpert's the claimed invention is enabled. The examiner opinion on the ultimate legal conclusion must be should never make this determination based on supported by something more than a conclusory personal opinion. The determination should always statementº); cf. In re Alton, 76 F.3d 1168, 1174, be based on the weight of all the evidence. 37 USPQ2d 1578, 1583 (Fed. Cir. 1996) (declarations relating to the written description 2164.05(a) Speci®cation Must Be Enabling requirement should have been considered). as of the Filing Date [R-08.2012]

Applicant should be encouraged to provide any Whether the speci®cation would have been enabling evidence to demonstrate that the disclosure enables as of the ®ling date involves consideration of the the claimed invention. In chemical and biotechnical nature of the invention, the state of the prior art, and applications, evidence actually submitted to the FDA the level of skill in the art. The initial inquiry is into to obtain approval for clinical trials may be the nature of the invention, i.e., the subject matter submitted. However, considerations made by the to which the claimed invention pertains. The nature FDA for approving clinical trials are different from of the invention becomes the backdrop to determine those made by the PTO in determining whether a the state of the art and the level of skill possessed claim is enabled. See Scott v. Finney, 34 F.3d 1058, by one skilled in the art.

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The state of the prior art is what one skilled in the document cannot enable technology that arises after art would have known, at the time the application the date of applicationº). Publications dated after was ®led, about the subject matter to which the the ®ling date providing information publicly ®rst claimed invention pertains. The relative skill of those disclosed after the ®ling date generally cannot be in the art refers to the skill of those in the art in used to show what was known at the time of ®ling. relation to the subject matter to which the claimed In re Gunn, 537 F.2d 1123, 1128, 190 USPQ invention pertains at the time the application was 402,405-06 (CCPA 1976); In re Budnick, 537 F.2d ®led. See MPEP § 2164.05(b). 535, 538, 190 USPQ 422, 424 (CCPA 1976) (In general, if an applicant seeks to use a patent to prove The state of the prior art provides evidence for the the state of the art for the purpose of the enablement degree of predictability in the art and is related to requirement, the patent must have an issue date the amount of direction or guidance needed in the earlier than the effective ®ling date of the speci®cation as ®led to meet the enablement application.). While a later dated publication cannot requirement. The state of the prior art is also related supplement an insuf®cient disclosure in a prior dated to the need for working examples in the application to make it enabling, applicant can offer speci®cation. the testimony of an expert based on the publication as evidence of the level of skill in the art at the time The state of the art for a given technology is not the application was ®led. Gould v. Quigg, 822 F.2d static in time. It is entirely possible that a disclosure 1074, 1077, 3 USPQ2d 1302, 1304 (Fed. Cir. 1987). which would not have been enabled if ®led on January 2, 1990 might be enabled if the same In general, the examiner should not use post-®ling disclosure had been ®led on January 2, 1996. date references to demonstrate that a patent is not Therefore, the state of the prior art must be evaluated enabled. Exceptions to this rule could occur if a for each application based on its ®ling date. later-dated reference provides evidence of what one skilled in the art would have known on or before the 35 U.S.C. 112 requires the speci®cation to be effective ®ling date of the patent application. In re enabling only to a person ªskilled in the art to which Hogan, 559 F.2d 595, 605, 194 USPQ 527, 537 it pertains, or with which it is most nearly (CCPA 1977). If individuals of skill in the art state connected.º In general, the pertinent art should be that a particular invention is not possible years after de®ned in terms of the problem to be solved rather the ®ling date, that would be evidence that the than in terms of the technology area, industry, trade, disclosed invention was not possible at the time of etc. for which the invention is used. ®ling. In In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513-14 (Fed. Cir. 1993) (an article The speci®cation need not disclose what is published 5 years after the ®ling date of the well-known to those skilled in the art and preferably application adequately supported the examiner's omits that which is well-known to those skilled and position that the physiological activity of certain already available to the public. In re Buchner, 929 viruses was suf®ciently unpredictable so that a F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. person skilled in the art would not have believed that 1991); Hybritech, Inc. v. Monoclonal Antibodies, the success with one virus and one animal could be Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. extrapolated successfully to all viruses with all living Cir. 1986), cert. denied, 480 U.S. 947 (1987); and organisms. Claims not directed to the speci®c virus Lindemann Maschinenfabrik GMBH v. American and the speci®c animal were held nonenabled). Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984). 2164.05(b) Speci®cation Must Be Enabling to Persons Skilled in the Art [R-08.2012] The state of the art existing at the ®ling date of the application is used to determine whether a particular The relative skill of those in the art refers to the skill disclosure is enabling as of the ®ling date. Chiron level of those in the art in the technological ®eld to Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 which the claimed invention pertains. Where USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (ªa patent different arts are involved in the invention, the

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speci®cation is enabling if it enables persons skilled In the chemical arts, the guidance and ease in in each art to carry out the aspect of the invention carrying out an assay to achieve the claimed applicable to their specialty. In re Naquin, 398 F.2d objectives may be an issue to be considered in 863, 866, 158 USPQ 317, 319 (CCPA 1968). determining the quantity of experimentation needed. For example, if a very dif®cult and time consuming When an invention, in its different aspects, involves assay is needed to identify a compound within the distinct arts, the speci®cation is enabling if it enables scope of a claim, then this great quantity of those skilled in each art, to carry out the aspect experimentation should be considered in the overall proper to their specialty. ªIf two distinct technologies analysis. Time and dif®culty of experiments are not are relevant to an invention, then the disclosure will determinative if they are merely routine. Quantity be adequate if a person of ordinary skill in each of of examples is only one factor that must be the two technologies could practice the invention considered before reaching the ®nal conclusion that from the disclosures.º Technicon Instruments undue experimentation would be required. In re Corp. v. Alpkem Corp., 664 F. Supp. 1558, 1578, 2 Wands, 858 F.2d at 737, 8 USPQ2d at 1404. USPQ2d 1729, 1742 (D. Ore. 1986), aff'd in part, vacated in part, rev'd in part, 837 F. 2d 1097 (Fed. I. EXAMPLE OF REASONABLE Cir. 1987) (unpublished opinion), appeal after EXPERIMENTATION remand, 866 F. 2d 417, 9 USPQ 2d 1540 (Fed. Cir. 1989). In Ex parte Zechnall, 194 USPQ 461 (Bd. In United States v. Telectronics, Inc., 857 F.2d 778, App. 1973), the Board stated ªappellants' disclosure 8 USPQ2d 1217 (Fed. Cir. 1988), cert. denied, must be held suf®cient if it would enable a person 490 U.S. 1046 (1989), the court reversed the ®ndings skilled in the electronic computer art, in cooperation of the district court for lack of clear and convincing with a person skilled in the fuel injection art, to make proof that undue experimentation was needed. The and use appellants' invention.º 194 USPQ at 461. court ruled that since one embodiment (stainless steel electrodes) and the method to determine 2164.06 Quantity of Experimentation dose/response was set forth in the speci®cation, the [R-08.2012] speci®cation was enabling. The question of time and expense of such studies, approximately $50,000 and 6-12 months standing alone, failed to show undue The quantity of experimentation needed to be experimentation. performed by one skilled in the art is only one factor involved in determining whether ªundue experimentationº is required to make and use the II. EXAMPLE OF UNREASONABLE EXPERIMENTATION invention. ª[A]n extended period of experimentation may not be undue if the skilled artisan is given In In re Ghiron, 442 F.2d 985, 991-92, 169 USPQ suf®cient direction or guidance.º In re Colianni, 723, 727-28 (CCPA 1971), functional ªblock 561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA diagramsº were insuf®cient to enable a person 1977).ª `The test is not merely quantitative, since a skilled in the art to practice the claimed invention considerable amount of experimentation is with only a reasonable degree of experimentation permissible, if it is merely routine, or if the because the claimed invention required a speci®cation in question provides a reasonable ªmodi®cation to prior art overlap computers,º and amount of guidance with respect to the direction in because ªmany of the components which appellants which the experimentation should proceed.'º In re illustrate as rectangles in their drawing necessarily Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 are themselves complex assemblages . . . . It is (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d common knowledge that many months or years 489, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)). elapse from the announcement of a new computer Time and expense are merely factors in this by a manufacturer before the ®rst prototype is consideration and are not the controlling factors. available. This does not bespeak of a routine United States v. Telectronics Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988), cert. denied, 490 U.S. 1046 (1989).

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operation but of extensive experimentation and speci®cation as to whether the parts represented by development work. . . .º boxes were ªoff the shelfº or must be speci®cally constructed or modi®ed for applicant's system. Also 2164.06(a) Examples of Enablement there were no details in the speci®cation of how the Issues-Missing Information [R-07.2015] parts should be interconnected, timed and controlled so as to obtain the speci®c operations desired by the It is common that doubt arises about enablement applicant. In In re Donohue, 550 F.2d 1269, 193 because information is missing about one or more USPQ 136 (CCPA 1977), the lack of enablement essential claim elements or relationships between was caused by lack of information in the elements which one skilled in the art could not speci®cation about a single block labelled ªLOGICº develop without undue experimentation. In such a in the drawings. See also Union Paci®c Resources case, the examiner should speci®cally identify what Co. v. Chesapeake Energy Corp., 236 F.3d 684, 57 information is missing and why the missing USPQ2d 1293 (Fed. Cir. 2001) (Claims directed to information is needed to provide enablement. a method of determining the location of a horizontal borehole in the earth failed to comply with I. ELECTRICAL AND MECHANICAL DEVICES enablement requirement of 35 U.S.C. 112 because OR PROCESSES certain computer programming details used to perform claimed method were not disclosed in the Enablement serves the dual function of ensuring speci®cation, and the record showed that a person adequate disclosure of the claimed invention and of of skill in art would not understand how to preventing claims broader than the disclosed ªcompareº or ªrescaleº data as recited in the claims invention. Broad claim language is used at the peril in order to perform the claimed method.). of losing any claim that cannot be enabled across its full scope. For example, in MagSil Corp. v. Hitachi In re Ghiron, 442 F.2d 985, 169 USPQ 723 (CCPA Global Storage Technologies Inc., 103 USPQ2d 1971), involved a method of facilitating transfers 1769 (Fed. Cir. 2012), the claim recited a change in from one subset of program instructions to another resistance by at least 10% at room temperature, but which required modi®cation of prior art ªoverlap the speci®cation contained no showing that the modeº computers. The Board rejected the claims on knowledge of a person of ordinary skill in the art at the basis, inter alia, that the disclosure was the time of ®ling would have been able to achieve insuf®cient to satisfy the requirements of 35 U.S.C. resistive changes in values that greatly exceed 10% 112, ®rst paragraph and was af®rmed. The Board without undue experimentation (noting that it took focused on the fact that the drawings were ªblock nearly 12 years of experimentation to achieve diagrams, i.e., a group of rectangles representing the modern values above 600%). See also Auto. Techs. elements of the system, functionally labelled and Intl, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, interconnected by lines.º 442 F.2d at 991, 169 USPQ 1283 (Fed. Cir. 2007) in which the claim limitation at 727. The speci®cation did not particularly identify means responsive to the motion of said mass was each of the elements represented by the blocks or construed to include both mechanical and electronic the relationship therebetween, nor did it specify side impact sensors for performing the function of particular apparatus intended to carry out each initiating an occupant protection apparatus. The function. The Board further questioned whether the speci®cation did not disclose any details or circuitry selection and assembly of the required components for electronic side impact sensors, and thus, failed could be carried out routinely by persons of ordinary to apprise one of ordinary skill how to make and use skill in the art. the electronic sensor. An adequate disclosure of a device may require A disclosure of an electrical circuit apparatus, details of how complex components are constructed depicted in the drawings by block diagrams with and perform the desired function. The claim before functional labels, was held to be nonenabling in In the court in In re Scarbrough, 500 F.2d 560, 182 re Gunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406 USPQ 298 (CCPA 1974) was directed to a system (CCPA 1976). There was no indication in the which comprised several component parts (e.g.,

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computer, timing and control mechanism, A/D had been appropriately deposited. The issue focused converter, etc.) only by generic name and overall on whether the speci®cation enabled one skilled in ultimate function. The court concluded that there the art to make any member of the species other than was not an enabling disclosure because the the three strains which had been deposited. The speci®cation did not describe how ªcomplex Board concluded that the verbal description of the elements known to perform broadly recited functions species was inadequate to allow a skilled artisan to in different systems would be adaptable for use in make any and all members of the claimed species. Appellant's particular system with only a reasonable Ex parte Jackson, 217 USPQ 804, 806 (Bd. App. amount of experimentationº and that ªan 1982). unreasonable amount of work would be required to arrive at the detailed relationships appellant says that See MPEP § 2402 - § 2411.03 for a detailed he has solved.º 500 F.2d at 566, 182 USPQ at 302. discussion of the deposit rules. See MPEP § 2411.01 for rejections under 35 U.S.C. 112 based on deposit II. MICROORGANISMS issues.

Patent applications involving living biological III. DRUG CASES products, such as microorganisms, as critical elements in the process of making the invention, See MPEP § 2107 - § 2107.03 for a discussion of present a unique question with regard to availability. the utility requirement under 35 U.S.C. 112(a) or The issue was raised in a case involving claims pre-AIA 35 U.S.C. 112, ®rst paragraph, in drug drawn to a fermentative method of producing two cases. novel antibiotics using a speci®c microorganism and claims to the novel antibiotics so produced. In 2164.06(b) Examples of Enablement Issues re Argoudelis, 434 F.2d 1390, 168 USPQ 99 (CCPA Ð Chemical Cases [R-08.2012] 1970). As stated by the court, ªa unique aspect of using microorganisms as starting materials is that a The following summaries should not be relied on to suf®cient description of how to obtain the support a case of lack of enablement without microorganism from nature cannot be given.º 434 carefully reading the case. F.2d at 1392, 168 USPQ at 102. It was determined by the court that availability of the biological product I. SEVERAL DECISIONS RULING THAT THE via a public depository provided an acceptable means DISCLOSURE WAS NONENABLING of meeting the written description and the enablement requirements of 35 U.S.C. 112, ®rst (A) In Enzo Biochem, Inc. v. Calgene, Inc., paragraph. 188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999), the court held that claims in two patents directed to To satisfy the enablement requirement a deposit must genetic antisense technology (which aims to control be made ªprior to issueº but need not be made prior gene expression in a particular organism), were to ®ling the application. In re Lundak, 773 F.2d invalid because the breadth of enablement was not 1216, 1223, 227 USPQ 90, 95 (Fed. Cir. 1985). commensurate in scope with the claims. Both speci®cations disclosed applying antisense The availability requirement of enablement must technology in regulating three genes in E. coli. also be considered in light of the scope or breadth Despite the limited disclosures, the speci®cations of the claim limitations. The Board of Appeals asserted that the ª[t]he practices of this invention considered this issue in an application which claimed are generally applicable with respect to any organism a fermentative method using microorganisms containing genetic material which is capable of being belonging to a species. Applicants had identi®ed expressed ¼ such as bacteria, yeast, and other three novel individual strains of microorganisms that cellular organisms.º The claims of the patents were related in such a way as to establish a new encompassed application of antisense methodology species of microorganism, a species being a broader in a broad range of organisms. Ultimately, the court classi®cation than a strain. The three speci®c strains relied on the fact that (1) the amount of direction

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presented and the number of working examples as the limited disclosure by appellants of the provided in the speci®cation were very narrow particular cyanobacterial genera operative in the compared to the wide breadth of the claims at issue, claimed invention....º The claims at issue were not (2) antisense gene technology was highly limited to any particular genus or species of unpredictable, and (3) the amount of experimentation cyanobacteria and the speci®cation mentioned nine required to adapt the practice of creating antisense genera and the working examples employed one DNA from E. coli to other types of cells was quite species of cyanobacteria. high, especially in light of the record, which included (E) In In re Colianni, 561 F.2d 220, 222-23, notable examples of the inventor's own failures to 195 USPQ 150, 152 (CCPA 1977), the court control the expression of other genes in E. coli and af®rmed a rejection under 35 U.S.C. 112, ®rst other types of cells. Thus, the teachings set forth in paragraph, because the speci®cation, which was the speci®cation provided no more than a ªplanº or directed to a method of mending a fractured bone ªinvitationº for those of skill in the art to experiment by applying ªsuf®cientº ultrasonic energy to the using the technology in other types of cells. bone, did not de®ne a ªsuf®cientº dosage or teach (B) In In re Wright, 999 F.2d 1557, 27 USPQ2d one of ordinary skill how to select the appropriate 1510 (Fed. Cir. 1993), the 1983 application disclosed intensity, frequency, or duration of the ultrasonic a vaccine against the RNA tumor virus known as energy. Prague Avian Sarcoma Virus, a member of the Rous II. SEVERAL DECISIONS RULING THAT THE Associated Virus family. Using functional language, DISCLOSURE WAS ENABLING Wright claimed a vaccine ªcomprising an immunologically effective amountº of a viral (A) In PPG Indus. v. Guardian Indus., 75 F.3d expression product. Id. at 1559, 27 USPQ2d at 1511. 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. Rejected claims covered all RNA viruses as well as 1996), the court ruled that even though there was a avian RNA viruses. The examiner provided a software error in calculating the ultraviolet teaching that in 1988, a vaccine for another retrovirus transmittance data for examples in the speci®cation (i.e., HIV) remained an intractable problem. This making it appear that the production of a cerium evidence, along with evidence that the RNA viruses oxide-free glass that satis®ed the transmittance were a diverse and complicated genus, convinced limitation would be dif®cult, the speci®cation the Federal Circuit that the invention was not enabled indicated that such glass could be made. The for either all retroviruses or even for avian speci®cation was found to indicate how to minimize retroviruses. the cerium content while maintaining low ultraviolet (C) In In re Goodman, 11 F.3d 1046, 29 transmittance. USPQ2d 2010 (Fed. Cir. 1993), a 1985 application (B) In In re Wands, 858 F.2d 731, 8 USPQ2d functionally claimed a method of producing protein 1400 (Fed. Cir. 1988), the court reversed the in plant cells by expressing a foreign gene. The court rejection for lack of enablement under 35 U.S.C. stated: ª[n]aturally, the speci®cation must teach 112, ®rst paragraph, concluding that undue those of skill in the art `how to make and use the experimentation would not be required to practice invention as broadly as it is claimed.'º Id. at 1050, the invention. The nature of monoclonal antibody 29 USPQ2d at 2013. Although protein expression technology is such that experiments ®rst involve the in dicotyledonous plant cells was enabled, the claims entire attempt to make monoclonal hybridomas to covered any plant cell. The examiner provided determine which ones secrete antibody with the evidence that even as late as 1987, use of the claimed desired characteristics. The court found that the method in monocot plant cells was not enabled. Id. speci®cation provided considerable direction and at 1051, 29 USPQ2d at 2014. guidance on how to practice the claimed invention (D) In In re Vaeck, 947 F.2d 488, 495, and presented working examples, that all of the 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the court methods needed to practice the invention were well found that several claims were not supported by an known, and that there was a high level of skill in the enabling disclosure ª[t]aking into account the art at the time the application was ®led. Furthermore, relatively incomplete understanding of the biology the applicant carried out the entire procedure for of cyanobacteria as of appellants' ®ling date, as well making a monoclonal antibody against HBsAg three

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times and each time was successful in producing at elements are totally within the con®nes of a least one antibody which fell within the scope of the computer. For instances where a computer invention claims. is claimed using functional language, that is not (C) In In re Bundy, 642 F.2d 430, 434, 209 limited to a speci®c structure, see MPEP § 2161.01. USPQ 48, 51-52 (CCPA 1981), the court ruled that appellant's disclosure was suf®cient to enable one I. BLOCK ELEMENTS MORE COMPREHENSIVE skilled in the art to use the claimed analogs of THAN A COMPUTER naturally occurring prostaglandins even though the speci®cation lacked any examples of speci®c The ®rst category of such block diagram cases dosages, because the speci®cation taught that the involves systems which include a computer as well novel prostaglandins had certain pharmacological as other system hardware and/or software properties and possessed activity similar to known components. In order to meet his or her burden of E-type prostaglandins. establishing a reasonable basis for questioning the adequacy of such disclosure, the examiner should 2164.06(c) Examples of Enablement Issues initiate a factual analysis of the system by focusing ± Computer Programming Cases [R-07.2015] on each of the individual block element components. More speci®cally, such an inquiry should focus on To establish a reasonable basis for questioning the the diverse functions attributed to each block element adequacy of a disclosure, the examiner must present as well as the teachings in the speci®cation as to a factual analysis of a disclosure to show that a how such a component could be implemented. If person skilled in the art would not be able to make based on such an analysis, the examiner can and use the claimed invention without resorting to reasonably contend that more than routine undue experimentation. experimentation would be required by one of ordinary skill in the art to implement such a In computer applications, it is not unusual for the component or components, then enablement of the claimed invention to involve two areas of prior art component or components should speci®cally be or more than one technology, e.g., an appropriately challenged by the examiner as part of a 35 U.S.C. programmed computer and an area of application of 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph said computer. White Consol. Indus. v. Vega rejection. Additionally, the examiner should Servo-Control, Inc., 214 USPQ 796, 821 (S.D.Mich. determine whether certain of the hardware or 1982). In regard to the ªskilled in the artº standard, software components depicted as block elements are in cases involving both the art of computer themselves complex assemblages which have widely programming, and another technology, the examiner differing characteristics and which must be precisely must recognize that the knowledge of persons skilled coordinated with other complex assemblages. Under in both technologies is the appropriate criteria for such circumstances, a reasonable basis may exist for determining suf®ciency. See In re Naquin, 398 F.2d challenging such a functional block diagram form 863, 158 USPQ 317 (CCPA 1968); In re Brown, of disclosure. See In re Ghiron, 442 F.2d 985, 169 477 F.2d 946, 177 USPQ 691 (CCPA 1973); White USPQ 723 (CCPA 1971) and In re Brown, supra. Consol. Indus., 214 USPQ at 822, aff'd on related Even if the applicant has cited prior art patents or grounds, 713 F.2d 788, 218 USPQ 961 (Fed. Cir. publications to demonstrate that particular block 1983). diagram hardware or software components are old, it should not always be considered as self-evident In a typical computer application, system how such components are to be interconnected to components are often represented in a ªblock function in a disclosed complex manner. See In re diagramº format, i.e., a group of hollow rectangles Scarbrough, 500 F.2d 560, 566, 182 USPQ 298, 301 representing the elements of the system, functionally (CCPA 1974) and In re Forman, 463 F.2d 1125, labeled, and interconnected by lines. Such block 1129, 175 USPQ 12, 16 (CCPA 1972). diagram computer cases may be categorized into (A) systems that include but are more comprehensive For example, where the speci®cation provides in a than a computer and (B) systems wherein the block block diagram disclosure of a complex system that

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includes a microprocessor and other system found that particular kinds of block diagram components controlled by the microprocessor, a disclosures were suf®cient to meet the enabling mere reference to a commercially available requirement of 35 U.S.C. 112(a) or pre-AIA 35 microprocessor, without any description of the U.S.C. 112, ®rst paragraph. See In re Knowlton, precise operations to be performed by the 481 F.2d 1357, 178 USPQ 486 (CCPA 1973), In re microprocessor, fails to disclose how such a Comstock, 481 F.2d 905, 178 USPQ 616 (CCPA microprocessor would be properly programmed to 1973). The Comstock and Knowlton decisions (1) either perform any required calculations or (2) turned on the appellants' disclosure of (1) a reference coordinate the other system components in the proper to and reliance on an identi®ed prior art computer timed sequence to perform the functions disclosed system and (2) an operative computer program for and claimed. If a particular program is disclosed in the referenced prior art computer system. In such a system, the program should be carefully Knowlton, the disclosure was presented in such a reviewed to ensure that its scope is commensurate detailed fashion that the individual program©s steps with the scope of the functions attributed to such a were speci®cally interrelated with the operative program in the claims. In re Brown, 477 F.2d at structural elements in the referenced prior art 951, 177 USPQ at 695. If (1) the disclosure fails to computer system. The court in Knowlton indicated disclose any program and (2) more than routine that the disclosure did not merely consist of a cursory experimentation would be required of one skilled in explanation of ¯ow diagrams or a bare group of the art to generate such a program, the examiner program listings together with a reference to a clearly would have a reasonable basis for challenging proprietary computer in which they might be run. the suf®ciency of such a disclosure. The amount of The disclosure was characterized as going into experimentation that is considered routine will vary considerable detail in explaining the depending on the facts and circumstances of interrelationships between the disclosed hardware individual cases and should be reviewed on a and software elements. Under such circumstances, case-by-case basis. No exact numerical standard has the court considered the disclosure to be concise as been ®xed by the courts, but the ªamount of required well as full, clear, and exact to a suf®cient degree experimentation must, however, be reasonable.º to satisfy the literal language of 35 U.S.C. 112, ®rst White Consol. Indus., 713 F.2d at 791, 218 USPQ paragraph. It must be emphasized that because of at 963. One court apparently found that the amount the signi®cance of the program listing and the of experimentation involved was reasonable where reference to and reliance on an identi®ed prior art a skilled programmer was able to write a general computer system, absent either of these items, a computer program, implementing an embodiment block element disclosure within the con®nes of a form, within 4 hours. Hirsch®eld v. Banner, 462 F. computer should be scrutinized in precisely the same Supp. 135, 142, 200 USPQ 276, 279 (D.D.C. 1978), manner as the ®rst category of block diagram cases aff'd, 615 F.2d 1368 (D.C. Cir. 1986), cert. denied, discussed above. 450 U.S. 994 (1981). Another court found that, where the required period of experimentation for Regardless of whether a disclosure involves block skilled programmers to develop a particular program elements more comprehensive than a computer or would run to 1 to 2 man years, this would be ªa block elements totally within the con®nes of a clearly unreasonable requirementº (White Consol. computer, USPTO personnel, when analyzing Indus., 713 F.2d at 791, 218 USPQ at 963). method claims, must recognize that the speci®cation must be adequate to teach how to practice the II. BLOCK ELEMENTS WITHIN A COMPUTER claimed method. If such practice requires a particular apparatus, then the application must provide a The second category of block diagram cases occurs suf®cient disclosure of that apparatus if such is not most frequently in pure data processing applications already available. See In re Ghiron, 442 F.2d 985, where the combination of block elements is totally 991, 169 USPQ 723, 727 (CCPA 1971) and In re within the con®nes of a computer, where there is no Gunn, 537 F.2d 1123, 1128, 190 USPQ 402, 406 interfacing with external apparatus other than normal (CCPA 1976). When USPTO personnel question input/output devices. In some instances, it has been the adequacy of computer system or computer

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programming disclosures, the reasons for ®nding burden involve submitting af®davits, referencing the speci®cation to be nonenabling should be prior art patents or technical publications, presenting supported by the record as a whole. In this regard, arguments of counsel, or combinations of these it is also essential for USPTO personnel to approaches. reasonably challenge evidence submitted by the applicant. For example, in In re Naquin, supra, an III. AFFIDAVIT PRACTICE (37 CFR 1.132) af®ant's statement that the average computer programmer was familiar with the subroutine In computer cases, af®davits must be critically necessary for performing the claimed process, was analyzed. Af®davit practice at the outset usually held to be a statement of fact as it was unchallenged involves analyzing the skill level and/or by USPTO personnel. In other words, unless USPTO quali®cations of the af®ant, which should be of the personnel present a reasonable basis for challenging person of ordinary skill in the art. When an af®ant's the disclosure in view of the record as a whole, a 35 skill level is higher than that required by the person U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst of ordinary skill in the art for a particular application, paragraph rejection in a computer system or an examiner may challenge the af®davit as computer programming application may not be insuf®cient should the af®ant not submit evidence sustained on appeal. See In re Naquin, supra, and demonstrating the amount of experimentation In re Morehouse, 545 F.2d 162, 165-66, 192 USPQ required by a person of ordinary skill in the art to 29, 32 (CCPA 1976). implement the invention. An af®ant having a skill level or quali®cations above that of the person of While no speci®c universally applicable rule exists ordinary skill in the art would require less for recognizing an insuf®ciently disclosed experimentation to implement the claimed invention application involving computer programs, an than that for the person of ordinary skill. Similarly, examining guideline to generally follow is to an af®ant having a skill level or quali®cations below challenge the suf®ciency of such disclosures which that of the person of ordinary skill in the art would fail to include either the programmed steps, require more experimentation to implement the algorithms or procedures that the computer performs claimed invention than that for the person of ordinary to accomplish the claimed function. These can be skill in the art. In either situation, the standard of the described in any way that would be understood by person of ordinary skill in the art would not have one of ordinary skill in the art, such as with a been met. reasonably detailed ¯owchart which delineates the sequence of operations the program must perform. In computer systems or programming cases, the In programming applications where the software problems with a given af®davit, which relate to the disclosure only includes a ¯owchart, as the suf®ciency of disclosure issue, generally involve complexity of functions and the generality of the af®ants submitting few facts to support their individual components of the ¯owchart increase, the conclusions or opinions. Some af®davits may go so basis for challenging the suf®ciency of such a far as to present conclusions on the ultimate legal ¯owchart becomes more reasonable because the question of suf®ciency. In re Brandstadter, 484 likelihood of more than routine experimentation F.2d 1395, 179 USPQ 286 (CCPA 1973), illustrates being required to generate a working program from the extent of the inquiry into the factual basis such a ¯owchart also increases. underlying an af®ant's conclusions or opinions. In Brandstadter, the invention concerned a stored As stated earlier, once USPTO personnel have program controller (computer) programmed to advanced a reasonable basis or presented evidence control the storing, retrieving, and forwarding of to question the adequacy of a computer system or messages in a communications system. The computer programming disclosure, the applicant disclosure consisted of broadly de®ned block must show that his or her speci®cation would enable diagrams of the structure of the invention and no one of ordinary skill in the art to make and use the ¯owcharts or program listings of the programs of claimed invention without resorting to undue the controller. The court quoted extensively from experimentation. In most cases, efforts to meet this the examiner's Of®ce actions and examiner's answer

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in its opinion where it was apparent that the examiner ®led his application. See In re Gunn, 537 F.2d 1123, consistently argued that the disclosure was merely 1128, 190 USPQ 402, 406 (CCPA 1976). In that a broad system diagram in the form of labeled block case, each of the af®ants stated what was known at diagrams along with statements of a myriad of the time he executed the af®davit, and not what was desired results. Various af®davits were presented in known at the time the applicant ®led his application. which the af®ants stated that all or some of the system circuit elements in the block diagrams were IV. REFERENCING PRIOR ART DOCUMENTS either well-known in the art or ªcould be constructedº by the skilled design engineer, that the The commercial availability of an identi®ed prior controller was ªcapable of being programmedº to art computer system is very pertinent to the issue of perform the stated functions or results desired, and enablement. But in some cases, this approach may that the person having ordinary skill in the art ªcould not be suf®cient to meet the applicant's burden. design or construct or was able to programº the Merely citing excerpts from technical publications system. The court did consider the af®ants' in an af®davit in order to satisfy the enablement statements as being some evidence on the ultimate requirement is not suf®cient if it is not made clear legal question of enablement but concluded that the that a person skilled in the art would know which, statements failed in their purpose since they recited or what parts, of the cited circuits could be used to conclusions or opinions with few facts to support or construct the claimed device or how they could be buttress these conclusions. With reference to the lack interconnected to act in combination to produce the of a disclosed computer program or even a ¯owchart required results. See In re Forman, 463 F.2d 1125, of the program to control the message switching 1129, 175 USPQ 12, 16 (CCPA 1972). This analysis system, the record contained no evidence as to the would appear to be less critical where the circuits number of programmers needed, the number of comprising applicant's system are essentially man-hours and the level of skill of the programmers standard components of an identi®ed prior art to produce the program required to practice the computer system and a standard device attached invention. thereto.

Factual evidence directed to the amount of time and Prior art patents are often relied on by applicants to effort and level of knowledge required for the show the state of the art for purposes of enablement. practice of the invention from the disclosure, and However, these patents must have an issue date knowledge in the art can be expected to rebut a earlier than the effective ®ling date of the application prima facie case of nonenablement, but not opinion under consideration. See In re Budnick, 537 F.2d evidence directed to the ultimate legal question of 535, 538, 190 USPQ 422, 424 (CCPA 1976). An enablement. See Hirsch®eld, 462 F. Supp. at 143, analogous point was made in In re Gunn, supra, 200 USPQ at 281. Where an af®davit shows that an where the court indicated that patents issued after inventor described the problem to be solved to an the ®ling date of the application under examination af®ant, which then enabled the af®ant to generate a are not evidence of subject matter known to any computer program to solve the problem, such an person skilled in the art since their subject matter af®davit will fail to demonstrate that the application may have been known only to the patentees and the alone would have taught a person of ordinary skill Patent and Trademark Of®ce. in the art how to make and use the claimed invention. See In re Brown, 477 F.2d at 951, 177 USPQ at Merely citing prior art patents to demonstrate that 695. In Brown, the court indicated that it had not the challenged components are old may not be been factually established that the applicant had not suf®cient proof since, even if each of the enumerated conveyed to the af®ant vital and additional devices or labelled blocks in a block diagram information in their several meetings in addition to disclosure were old, per se, this would not make it that set out in the application. For an af®davit to be self-evident how each would be interconnected to relevant to the determination of enablement, it must function in a disclosed complex combination manner. be probative of the level of skill of the personal of Therefore, the speci®cation in effect must set forth ordinary skill in the art as of the time the applicant the integration of the prior art; otherwise, it is likely

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that undue experimentation, or more than routine that some speci®c, substantial, and credible use be experimentation would be required to implement the set forth for the invention. On the other hand, 35 claimed invention. See In re Scarbrough, 500 F.2d U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst 560, 565, 182 USPQ 298, 301 (CCPA 1974). The paragraph requires an indication of how the use court also noted that any cited patents which are used (required by 35 U.S.C. 101) can be carried out, i.e., by the applicant to demonstrate that particular box how the invention can be used. diagram hardware or software components are old must be analyzed as to whether such patents are If an applicant has disclosed a speci®c and germane to the instant invention and as to whether substantial utility for an invention and provided a such patents provide better detail of disclosure as to credible basis supporting that utility, that fact alone such components than an applicant's own disclosure. does not provide a basis for concluding that the Also, any patent or publication cited to provide claims comply with all the requirements of 35 U.S.C. evidence that a particular programming technique 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph. is well-known in the programming art does not For example, if an applicant has claimed a process demonstrate that one of ordinary skill in the art could of treating a certain disease condition with a certain make and use correspondingly disclosed compound and provided a credible basis for asserting programming techniques unless both programming that the compound is useful in that regard, but to techniques are of approximately the same degree of actually practice the invention as claimed a person complexity. See In re Knowlton, 500 F.2d 566, 572, skilled in the relevant art would have to engage in 183 USPQ 33, 37 (CCPA 1974). an undue amount of experimentation, the claim may be defective under 35 U.S.C. 112, but not 35 U.S.C. V. ARGUMENTS OF COUNSEL 101. To avoid confusion during examination, any rejection under 35 U.S.C. 112(a) or pre-AIA 35 Arguments of counsel may be effective in U.S.C. 112, ®rst paragraph, based on grounds other establishing that an examiner has not properly met than ªlack of utilityº should be imposed separately his or her burden or has otherwise erred in his or her from any rejection imposed due to ªlack of utilityº position. However, it must be emphasized that under 35 U.S.C. 101 and 35 U.S.C. 112(a) or arguments of counsel alone cannot take the place of pre-AIA 35 U.S.C. 112, ®rst paragraph. evidence in the record once an examiner has advanced a reasonable basis for questioning the I. WHEN UTILITY REQUIREMENT IS NOT disclosure. See In re Budnick, 537 F.2d at 538, SATISFIED 190 USPQ at 424; In re Schulze, 346 F.2d 600, 145 USPQ 716 (CCPA 1965); In re Cole, 326 F.2d 769, A. Not Useful or Operative 140 USPQ 230 (CCPA 1964). For example, in a case where the record consisted substantially of If a claim fails to meet the utility requirement of arguments and opinions of applicant's attorney, the 35 U.S.C. 101 because it is shown to be nonuseful court indicated that factual af®davits could have or inoperative, then it necessarily fails to meet the provided important evidence on the issue of how-to-use aspect of the enablement requirement of enablement. See In re Knowlton, 500 F.2d at 572, 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst 183 USPQ at 37; In re Wiseman, 596 F.2d 1019, paragraph. As noted in In re Fouche, 439 F.2d 1237, 201 USPQ 658 (CCPA 1979). 169 USPQ 429 (CCPA 1971), if ªcompositions are in fact useless, appellant's speci®cation cannot have 2164.07 Relationship of Enablement taught how to use them.º 439 F.2d at 1243, 169 Requirement to Utility Requirement of 35 USPQ at 434. The examiner should make both U.S.C. 101 [R-11.2013] rejections (i.e., a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph and a rejection under 35 U.S.C. 101) where the subject The requirement of 35 U.S.C. 112(a) or pre-AIA 35 matter of a claim has been shown to be nonuseful U.S.C. 112, ®rst paragraph as to how to use the or inoperative. invention is different from the utility requirement of 35 U.S.C. 101. The requirement of 35 U.S.C. 101 is

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The 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 1441 (Fed. Cir. 1995) (citing In re Bundy, 642 F.2d ®rst paragraph, rejection should indicate that because 430, 433, 209 USPQ 48, 51 (CCPA 1981)). the invention as claimed does not have utility, a person skilled in the art would not be able to use the C. Rebuttal by Applicant invention as claimed, and as such, the claim is defective under 35 U.S.C. 112(a) or pre-AIA 35 If a rejection under 35 U.S.C. 101 has been properly U.S.C. 112, ®rst paragraph. A 35 U.S.C. 112(a) or imposed, along with a corresponding rejection under pre-AIA 35 U.S.C. 112, ®rst paragraph, rejection 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst should not be imposed or maintained unless an paragraph, the burden shifts to the applicant to rebut appropriate basis exists for imposing a rejection the prima facie showing. In re Oetiker, 977 F.2d under 35 U.S.C. 101. In other words, Of®ce 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. personnel should not impose a 35 U.S.C. 112(a) or 1992). There is no predetermined amount or pre-AIA 35 U.S.C. 112, ®rst paragraph, rejection character of evidence that must be provided by an grounded on a ªlack of utilityº basis unless a 35 applicant to support an asserted utility. Rather, the U.S.C. 101 rejection is proper. In particular, the character and amount of evidence needed to support factual showing needed to impose a rejection under an asserted utility will vary depending on what is 35 U.S.C. 101 must be provided if a 35 U.S.C. claimed (Ex parte Ferguson, 117 USPQ 229, 231 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, (Bd. App. 1957)), and whether the asserted utility rejection is to be imposed on ªlack of utilityº appears to contravene established scienti®c grounds. See MPEP § 2107 - § 2107.03 for a more principles and beliefs. In re Gazave, 379 F.2d 973, detailed discussion of the utility requirements of 35 978, 154 USPQ 92, 96 (CCPA 1967 ); In re U.S.C. 101 and 35 U.S.C. 112(a) or pre-AIA 112, Chilowsky, 229 F.2d 457, 462, 108 USPQ 321, 325 ®rst paragraph. (CCPA 1956). Furthermore, the applicant does not have to provide evidence suf®cient to establish that B. Burden on the Examiner an asserted utility is true ªbeyond a reasonable doubt.º In re Irons, 340 F.2d 974, 978, 144 USPQ When the examiner concludes that an application 351, 354 (CCPA 1965). Instead, evidence will be claims an invention that is nonuseful, inoperative, suf®cient if, considered as a whole, it leads a person or contradicts known scienti®c principles, the burden of ordinary skill in the art to conclude that the is on the examiner to provide a reasonable basis to asserted utility is more likely than not true. See support this conclusion. Rejections based on 35 MPEP § 2107.02 for a more detailed discussion of U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst consideration of a reply to a prima facie rejection paragraph, and 35 U.S.C. 101 should be made. for lack of utility and evaluation of evidence related to utility. Examiner Has Initial Burden To Show That One of Ordinary Skill in the Art Would Reasonably Doubt II. WHEN UTILITY REQUIREMENT IS the Asserted Utility SATISFIED

The examiner has the initial burden of challenging In some instances, the utility of the claimed invention an asserted utility. Only after the examiner has will be provided, but the skilled artisan will not know provided evidence showing that one of ordinary skill how to effect that use. In such a case, no rejection in the art would reasonably doubt the asserted utility will be made under 35 U.S.C. 101, but a rejection does the burden shift to the applicant to provide will be made under 35 U.S.C. 112(a) or pre-AIA 35 rebuttal evidence suf®cient to convince one of U.S.C. 112, ®rst paragraph. As pointed out in ordinary skill in the art of the invention's asserted Mowry v. Whitney, 81 U.S. (14 Wall.) 620 (1871), utility. In re Fisher, 421 F.3d 1365, 76 USPQ2d an invention may in fact have great utility, i.e., may 1225 (Fed. Cir. 2005); In re Swartz, 232 F.3d 862, be ªa highly useful invention,º but the speci®cation 863, 56 USPQ2d 1703, 1704 (Fed. Cir. 2000); In may still fail to ªenable any person skilled in the art re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436,

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or scienceº to use the invention. 81 U.S. (14 Wall.) claims. See, e.g., In re Fisher, 427 F.2d 833, 839, at 644. 166 USPQ 18, 24 (CCPA 1970).

2164.08 Enablement Commensurate in Scope With respect to the breadth of a claim, the relevant With the Claims [R-11.2013] concern is whether the scope of enablement provided to one skilled in the art by the disclosure is All questions of enablement are evaluated against commensurate with the scope of protection sought the claimed subject matter. The focus of the by the claims. AK Steel Corp. v. Sollac, 344 F.3d examination inquiry is whether everything within 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. the scope of the claim is enabled. Accordingly, the 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ ®rst analytical step requires that the examiner 236, 239 (CCPA 1971). See also Plant Genetic Sys., determine exactly what subject matter is N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, encompassed by the claims. See, e.g., AK Steel 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d ªpioneer statusº of invention irrelevant to 1280, 1287 (Fed. Cir. 2003) (When a range is enablement determination). claimed, there must be reasonable enablement of the scope of the range. Here, the claims at issue The propriety of a rejection based upon the scope of encompassed amounts of silicon as high as 10% by a claim relative to the scope of the enablement weight, however the speci®cation included concerns (1) how broad the claim is with respect to statements clearly and strongly warning that a silicon the disclosure and (2) whether one skilled in the art content above 0.5% by weight in an aluminum could make and use the entire scope of the claimed coating causes coating problems. Such statements invention without undue experimentation. indicate that higher amounts will not work in the claimed invention.). The examiner should determine An enabling disclosure may be set forth by speci®c what each claim recites and what the subject matter example or broad terminology; the exact form of is when the claim is considered as a whole, not when disclosure is not dispositive. In re Marzocchi, 439 its parts are analyzed individually. No claim should F.2d 220, 223-24 169 USPQ 367, 370 (CCPA 1971). be overlooked. With respect to dependent claims, A rejection of a claim under 35 U.S.C. 112 as 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth broader than the enabling disclosure is a 35 U.S.C. paragraph, should be followed. These paragraphs 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, state ªa claim in a dependent form shall be construed enablement rejection and not a 35 U.S.C. 112(b) or to incorporate by reference all the limitations of the pre-AIA 35 U.S.C. 112, second paragraph, claim to which it refersº and requires the dependent de®niteness rejection. Claims are not rejected as claim to further limit the subject matter claimed. broader than the enabling disclosure under 35 U.S.C. 112 for noninclusion of limitations dealing with The Federal Circuit has repeatedly held that ªthe factors which must be presumed to be within the speci®cation must teach those skilled in the art how level of ordinary skill in the art; the claims need not to make and use the full scope of the claimed recite such factors where one of ordinary skill in the invention without `undue experimentation'.º In re art to whom the speci®cation and claims are directed Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, would consider them obvious. In re Skrivan, 427 1513 (Fed. Cir. 1993). Nevertheless, not everything F.2d 801, 806, 166 USPQ 85, 88 (CCPA 1970). One necessary to practice the invention need be disclosed. does not look to the claims but to the speci®cation In fact, what is well-known is best omitted. In re to ®nd out how to practice the claimed invention. Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d (Fed. Cir. 1991). All that is necessary is that one 1540, 1558, 220 USPQ 303, 316-17 (Fed. Cir. 1983); skilled in the art be able to practice the claimed In re Johnson, 558 F.2d 1008, 1017, 194 USPQ invention, given the level of knowledge and skill in 187, 195 (CCPA 1977). In In re Goffe, 542 F.2d the art. Further the scope of enablement must only 564, 567, 191 USPQ 429, 431 (CCPA 1976), the bear a ªreasonable correlationº to the scope of the court stated:

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[T]o provide effective incentives, claims must support for Amgen's desire to claim all EPO adequately protect inventors. To demand that gene analogs. There may be many other genetic the ®rst to disclose shall limit his claims to sequences that code for EPO-type products. what he has found will work or to materials Amgen has told how to make and use only a which meet the guidelines speci®ed for few of them and is therefore not entitled to ªpreferredº materials in a process such as the claim all of them. one herein involved would not serve the constitutional purpose of promoting progress 927 F.2d at 1213-14, 18 USPQ2d at 1027. However, in the useful arts. when claims are directed to any puri®ed and isolated DNA sequence encoding a speci®cally named When analyzing the enabled scope of a claim, the protein where the protein has a speci®cally identi®ed teachings of the speci®cation must not be ignored sequence, a rejection of the claims as broader than because claims are to be given their broadest the enabling disclosure is generally not appropriate reasonable interpretation that is consistent with the because one skilled in the art could readily determine speci®cation. ªThat claims are interpreted in light any one of the claimed embodiments. of the speci®cation does not mean that everything in the speci®cation must be read into the claims.º See also In re Wright, 999 F.2d 1557, 1562, Raytheon Co. v. Roper Corp., 724 F.2d 951, 957, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993) (The 220 USPQ 592, 597 (Fed. Cir. 1983), cert. denied, evidence did not show that a skilled artisan would 469 U.S. 835 (1984). have been able to carry out the steps required to practice the full scope of claims which encompass The record must be clear so that the public will have ªany and all live, non-pathogenic vaccines, and notice as to the patentee's scope of protection when processes for making such vaccines, which elicit the patent issues. If a reasonable interpretation of immunoprotective activity in any animal toward any the claim is broader than the description in the RNA virus.º (original emphasis)); In re Goodman, speci®cation, it is necessary for the examiner to 11 F.3d 1046, 1052, 29 USPQ2d 2010, 2015 (Fed. make sure the full scope of the claim is enabled. Cir. 1993) (The speci®cation did not enable the Limitations and examples in the speci®cation do not broad scope of the claims for producing mammalian generally limit what is covered by the claims. peptides in plant cells because the speci®cation contained only an example of producing The breadth of the claims was a factor considered gamma-interferon in a dicot species, and there was in Amgen v. Chugai Pharm. Co., 927 F.2d 1200, 18 evidence that extensive experimentation would have USPQ2d 1016 (Fed. Cir. 1991), cert. denied, been required for encoding mammalian peptide into 502 U.S. 856 (1991). In Amgen, the patent claims a monocot plant at the time of ®ling); In re Fisher, were directed to a puri®ed DNA sequence encoding 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) polypeptide analogs of the protein erythropoietin (Where applicant claimed a composition suitable for (EPO). The court stated that: the treatment of arthritis having a potency of ªat leastº a particular value, the court held that the claim Amgen has not enabled preparation of DNA was not commensurate in scope with the enabling sequences suf®cient to support its disclosure because the disclosure was not enabling all-encompassing claims. . . . [D]espite for compositions having a slightly higher potency. extensive statements in the speci®cation Simply because applicant was the ®rst to achieve a concerning all the analogs of the EPO gene that composition beyond a particular threshold potency can be made, there is little enabling disclosure did not justify or support a claim that would of particular analogs and how to make them. dominate every composition that exceeded that Details for preparing only a few EPO analog threshold value.); In re Vaeck, 947 F.2d 488, 495, genes are disclosed. . . . This disclosure might 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (Given the well justify a generic claim encompassing these relatively incomplete understanding in the and similar analogs, but it represents inadequate biotechnological ®eld involved, and the lack of a reasonable correlation between the narrow disclosure

Rev. 07.2015, October 2015 2100-276 PATENTABILITY § 2164.08(c)

in the speci®cation and the broad scope of protection those embodiments that are operable. A disclosure sought in the claims, a rejection under 35 U.S.C. of a large number of operable embodiments and the 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph identi®cation of a single inoperative embodiment for lack of enablement was appropriate.). did not render a claim broader than the enabled scope because undue experimentation was not involved in If a rejection is made based on the view that the determining those embodiments that were operable. enablement is not commensurate in scope with the In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ claim, the examiner should identify the subject 214, 218 (CCPA 1976). However, claims reading matter that is considered to be enabled. on signi®cant numbers of inoperative embodiments would render claims nonenabled when the 2164.08(a) Single Means Claim [R-11.2013] speci®cation does not clearly identify the operative embodiments and undue experimentation is involved A single means claim, i.e., where a means recitation in determining those that are operative. Atlas does not appear in combination with another recited Powder Co. v. E.I. duPont de Nemours & Co., 750 element of means, is subject to an enablement F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. rejection under 35 U.S.C. 112(a) or pre-AIA 35 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ U.S.C. 112, ®rst paragraph. In re Hyatt, 708 F.2d 298, 302 (CCPA 1971). 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which covered every 2164.08(c) Critical Feature Not Claimed conceivable means for achieving the stated purpose [R-08.2012] was held nonenabling for the scope of the claim because the speci®cation disclosed at most only A feature which is taught as critical in a speci®cation those means known to the inventor.). When claims and is not recited in the claims should result in a depend on a recited property, a fact situation rejection of such claim under the enablement comparable to Hyatt is possible, where the claim provision section of 35 U.S.C. 112. See In covers every conceivable structure (means) for re Mayhew, 527 F.2d 1229, 1233, 188 USPQ 356, achieving the stated property (result) while the 358 (CCPA 1976). In determining whether an speci®cation discloses at most only those known to unclaimed feature is critical, the entire disclosure the inventor. must be considered. Features which are merely preferred are not to be considered critical. In 2164.08(b) Inoperative Subject Matter re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 [R-08.2012] (CCPA 1976).

The presence of inoperative embodiments within the Limiting an applicant to the preferred materials in scope of a claim does not necessarily render a claim the absence of limiting prior art would not serve the nonenabled. The standard is whether a skilled person constitutional purpose of promoting the progress in could determine which embodiments that were the useful arts. Therefore, an enablement rejection conceived, but not yet made, would be inoperative based on the grounds that a disclosed critical or operative with expenditure of no more effort than limitation is missing from a claim should be made is normally required in the art. Atlas Powder Co. v. only when the language of the speci®cation makes E.I. du Pont de Nemours & Co., 750 F.2d 1569, it clear that the limitation is critical for the invention 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) to function as intended. Broad language in the (prophetic examples do not make the disclosure disclosure, including the abstract, omitting an nonenabling).

Although, typically, inoperative embodiments are excluded by language in a claim (e.g., preamble), the scope of the claim may still not be enabled where undue experimentation is involved in determining

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allegedly critical feature, tends to rebut the argument disclose for the claimed subject matter the best mode of criticality. contemplated by the inventor even if the inventor was not the discoverer of that mode. Benger Labs. 2165 The Best Mode Requirement Ltd. v. R.K. Laros Co., 209 F. Supp. 639, 135 USPQ [R-11.2013] 11 (E.D. Pa. 1962).

I. REQUIREMENT FOR A DISCLOSURE OF THE Failure to disclose the best mode need not rise to the BEST MODE level of active concealment or inequitable conduct in order to support a rejection. Where an inventor A third requirement of 35 U.S.C. 112(a) (applicable knows of a speci®c material or method that will to applications ®led on or after September 16, 2012) make possible the successful reproduction of the is that: claimed invention, but does not disclose it, the best mode requirement has not been satis®ed. Union Carbide Corp. v. Borg-Warner, 550 F.2d 555, 193 The speci®cation. . . shall set forth the best USPQ 1 (6th Cir. 1977). mode contemplated by the inventor or joint inventor of carrying out the invention. II. IMPACT OF FAILURE TO DISCLOSE THE BEST MODE PURSUANT TO THE AIA The third requirement of the ®rst paragraph of pre-AIA 35 U.S.C. 112 (applicable to applications Section 15 of the Leahy-Smith America Invents Act ®led before September 16, 2012) is that: (AIA), Pub. L. 112-29, 125 Stat. 284 (September 16, 2011), did not eliminate the requirement in The speci®cation. . . shall set forth the best pre-AIA 35 U.S.C. 112 , ®rst paragraph, for a mode contemplated by the inventor of carrying disclosure of the best mode, (see 35 U.S.C. 112(a)) out his invention. but effective September 16, 2011, it amended 35 U.S.C. 282 (the provision that sets forth defenses in The best mode requirement is a safeguard against a patent validity or infringement proceeding) to the desire on the part of some people to obtain patent provide that the failure to disclose the best mode protection without making a full disclosure as shall not be a basis on which any claim of a patent required by the statute. The requirement does not may be canceled or held invalid or otherwise permit inventors to disclose only what they know to unenforceable. As this change is applicable only in be their second-best embodiment, while retaining patent validity or infringement proceedings, it does the best for themselves. In re Nelson, 280 F.2d 172, not alter current patent examining practices as set 126 USPQ 242 (CCPA 1960). forth above for evaluation of an application for compliance with the best mode requirement of 35 U.S.C. 112 . Determining compliance with the best mode requirement requires a two-prong inquiry. First, it must be determined whether, at the time the Prior to September 16, 2011, for an invention application was ®led, the inventor possessed a best claimed in a later-®led application to receive the mode for practicing the invention. This is a bene®t of the ®ling date of an earlier-®led subjective inquiry which focuses on the inventor's application, 35 U.S.C. 119(e) and 120 required that state of mind at the time of ®ling. Second, if the the invention claimed in the later-®led application inventor did possess a best mode, it must be be disclosed in the earlier-®led application in the determined whether the written description disclosed manner provided by pre-AIA 35 U.S.C. 112, ®rst the best mode such that a person skilled in the art paragraph. Section 15 of the Leahy-Smith America could practice it. This is an objective inquiry, Invents Act also amended 35 U.S.C. 119(e) and 120 focusing on the scope of the claimed invention and to modify this requirement such that the disclosure the level of skill in the art. Eli Lilly & Co. v. Barr in the earlier ®led application must be made in the Lab. Inc., 251 F.3d 955, 963, 58 USPQ2d 1865, 1874 manner provided by pre-AIA 35 U.S.C. 112, ®rst (Fed. Cir. 2001). All applicants are required to paragraph, "other than the requirement to disclose

Rev. 07.2015, October 2015 2100-278 PATENTABILITY § 2165.01

the best mode." This change should not noticeably The absence of a speci®c working example is not impact patent examining procedure. MPEP § 201.08 necessarily evidence that the best mode has not been provides that there is no need to determine whether disclosed, nor is the presence of one evidence that the earlier-®led application contains a disclosure of it has. Best mode may be represented by a preferred the invention claimed in the later ®led application range of conditions or group of reactants. In re in compliance with pre-AIA 35 U.S.C. 112, ®rst Honn, 364 F.2d 454, 150 USPQ 652 (CCPA 1966). paragraph, unless the ®ling date of the earlier-®led application is actually necessary (e.g., to overcome III. DESIGNATION AS BEST MODE IS NOT a reference). Examiners should consult with their REQUIRED supervisors if it appears that an earlier-®led application does not disclose the best mode for There is no requirement in the statute that applicants carrying out a claimed invention and the ®ling date point out which of their embodiments they consider of the earlier-®led application is actually necessary. to be their best; that the disclosure includes the best 35 U.S.C. 119(e) and 120 were further amended mode contemplated by applicants is enough to satisfy effective for applications ®led on or after September the statute. Ernsthausen v. Nakayama, 1 USPQ2d 16, 2012 to refer to 35 U.S.C. 112(a) rather than 1539 (Bd. Pat. App. & Inter. 1985). pre-AIA 35 U.S.C. 112, ®rst paragraph. IV. UPDATING BEST MODE IS NOT REQUIRED 2165.01 Considerations Relevant to Best Mode [R-11.2013] There is no requirement to update in the context of a foreign priority application under 35 U.S.C. 119, I. DETERMINE WHAT IS THE INVENTION Standard Oil Co. v. Montedison, S.p.A., 494 F.Supp. 370, 206 USPQ 676 (D.Del. 1980) (better catalyst Determine what the invention is Ð the invention is developed between Italian priority and U.S. ®ling de®ned in the claims. The speci®cation need not set dates). Furthermore, it is not necessary to update the forth details not relating to the essence of the best mode in applications claiming the bene®t of an invention. In re Bosy, 360 F.2d 972, 149 USPQ 789 earlier ®ling date under 35 U.S.C. 119(e) or 120, (CCPA 1966). See also Northern Telecom Ltd. v. which indicate that the disclosure in the earlier ®led Samsung Elec. Co., 215 F.3d 1281, 55 USPQ2d 1065 application must be made in the manner provided (Fed. Cir. 2000) (Unclaimed matter that is unrelated by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst to the operation of the claimed invention does not paragraph, "other than the requirement to disclose trigger the best mode requirement); Eli Lilly & Co. the best mode." See MPEP § 2165, subsection II. v. Barr Lab. Inc., 251 F.3d 955, 966, 58 USPQ2d 1865, 1877 (Fed. Cir. 2001) (ª[P]atentee's failure V. DEFECT IN BEST MODE CANNOT BE CURED to disclose an unclaimed preferred mode for BY NEW MATTER accomplishing a routine detail does not violate the best mode requirement because one skilled in the If the best mode contemplated by the inventor at the art is aware of alternative means for accomplishing time of ®ling the application is not disclosed, such the routine detail that would still produce the best a defect cannot be cured by submitting an mode of the claimed invention.º). amendment seeking to put into the speci®cation something required to be there when the patent II. SPECIFIC EXAMPLE IS NOT REQUIRED application was originally ®led. In re Hay, 534 F.2d 917, 189 USPQ 790 (CCPA 1976). There is no statutory requirement for the disclosure of a speci®c example Ð a patent speci®cation is not Any proposed amendment of this type (adding a intended nor required to be a production speci®c mode of practicing the invention not speci®cation. In re Gay, 309 F.2d 768, 135 USPQ described in the application as ®led) should be 311 (CCPA 1962). treated as new matter. New matter under 35 U.S.C.

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132 and 251 should be objected to and coupled with WHETHER THE DISCLOSURE IS ADEQUATE TO a requirement to cancel the new matter. ENABLE ONE OF ORDINARY SKILL IN THE ART TO PRACTICE THE BEST MODE 2165.02 Best Mode Requirement Compared to Enablement Requirement [R-11.2013] According to the approach used by the court in Chemcast Corp. v. Arco Indus., 913 F.2d 923, 16 USPQ2d 1033 (Fed. Cir. 1990), a proper best The best mode requirement is a separate and distinct mode analysis has two components: requirement from the enablement requirement of 35 U.S.C. 112(a) or the ®rst paragraph of pre-AIA 35 (A) Determine whether, at the time the U.S.C. 112. In re Newton, 414 F.2d 1400, 163 application was ®led, the inventor knew of a mode USPQ 34 (CCPA 1969). of practicing the claimed invention that the inventor considered to be better than any other. The best mode provision of 35 U.S.C. 112 is not directed to a situation where the application fails to The ®rst component is a subjective inquiry because set forth any mode Ð such failure is equivalent to it focuses on the inventor's state of mind at the time nonenablement. In re Glass, 492 F.2d 1228, the application was ®led. Unless the examiner has 181 USPQ 31 (CCPA 1974). evidence that the inventors had information in their possession The enablement requirement looks to placing the subject matter of the claims generally in the (1) at the time the application was ®led possession of the public. If, however, the applicant (2) that a mode was considered to be better develops speci®c instrumentalities or techniques than any others by the inventors, which are recognized by the applicant at the time of ®ling as the best way of carrying out the invention, there is no reason to address the second component then the best mode requirement imposes an and there is no proper basis for a best mode rejection. obligation to disclose that information to the public If the facts satisfy the ®rst component, then, and as well. Spectra-Physics, Inc. v. Coherent, Inc., 827 only then, is the following second component F.2d 1524, 3 USPQ 2d 1737 (Fed. Cir.), cert. analyzed: denied, 484 U.S. 954 (1987). (B) Compare what was known in (A) with what was disclosed - is the disclosure adequate to enable 2165.03 Requirements for Rejection for Lack one skilled in the art to practice the best mode? of Best Mode [R-11.2013] Assessing the adequacy of the disclosure in this I. ASSUME BEST MODE IS DISCLOSED UNLESS regard is largely an objective inquiry that depends THERE IS EVIDENCE TO THE CONTRARY on the level of skill in the art. Is the information contained in the speci®cation disclosure suf®cient The examiner should assume that the best mode is to enable a person skilled in the relevant art to make disclosed in the application, unless evidence is and use the best mode? presented that is inconsistent with that assumption. It is extremely rare that a best mode rejection A best mode rejection is proper only when the ®rst properly would be made in ex parte prosecution. inquiry can be answered in the af®rmative, and the The information that is necessary to form the basis second inquiry answered in the negative with reasons for a rejection based on the failure to set forth the best mode is rarely accessible to the examiner, but is generally uncovered during inter partes proceedings.

II. EXAMINER MUST DETERMINE WHETHER THE INVENTOR KNEW THAT ONE MODE WAS BETTER THAN ANOTHER, AND IF SO,

Rev. 07.2015, October 2015 2100-280 PATENTABILITY § 2165.04

to support the conclusion that the speci®cation is claimed invention. ªKnown ways of performing a nonenabling with respect to the best mode. known operation cannot be deemed intentionally concealed absent evidence of intent to deliberately 2165.04 Examples of Evidence of withhold that information.º High Concrete Concealment [R-08.2012] Structures Inc. v. New Enter. Stone & Lime Co., 377 F.3d 1379, 1384, 71 USPQ2d 1948, 1951 (Fed. In determining the adequacy of a best mode Cir. 2004). The unintentional failure to disclose in disclosure, only evidence of concealment (accidental the speci®cation the use of a crane to support the or intentional) is to be considered. That evidence patented frame in order to carry out the method of must tend to show that the quality of an applicant's loading and tilting the frame was held not to defeat best mode disclosure is so poor as to effectively the best mode requirement because one of ordinary result in concealment. skill in the art would understand and use a crane to move heavy loads. Id. ªThe best mode requirement I. EXAMPLES Ð BEST MODE REQUIREMENT of [35 U.S.C.] § 112 is not violated by unintentional SATISFIED omission of information that would be readily known to persons in the ®eld of the invention.º Id. In one case, even though the inventor had more information in his possession concerning the There was no best mode violation where there was contemplated best mode than was disclosed (a known no evidence that the monoclonal antibodies used by computer program) the speci®cation was held to the inventors differed from those obtainable delineate the best mode in a manner suf®cient to according to the processes described in the require only the application of routine skill to speci®cation. It was not disputed that the inventors produce a workable digital computer program. In obtained the antibodies used in the invention by re Sherwood, 613 F.2d 809, 204 USPQ 537 (CCPA following the procedures in the speci®cation, that 1980). these were the inventors' preferred procedures, and that the data reported in the speci®cation was for the In another case, the claimed subject matter was a antibody that the inventors had actually used. time controlled thermostat, but the application did Scripps Clinic and Research Found. v. Genentech, not disclose the speci®c Quartzmatic motor which Inc., 927 F.2d 1565, 18 USPQ 2d 1001 (Fed. Cir. was used in a commercial embodiment. The court 1991). concluded that failure to disclose the commercial motor did not amount to concealment since similar Where an organism was created by the insertion of clock motors were widely available and widely genetic material into a cell obtained from generally advertised. There was no evidence that the speci®c available sources, all that was required to satisfy the Quartzmatic motor was superior except possibly in best mode requirement was an adequate description price. Honeywell v. Diamond, 208 USPQ 452 of the means for carrying out the invention, not (D.D.C. 1980). deposit of the cells. As to the observation that no scientist could ever duplicate exactly the cell used There was held to be no violation of the best mode by applicants, the court observed that the issue is requirement even though the inventor did not whether the disclosure is adequate, not that an exact disclose the only mode of calculating the stretch rate duplication is necessary. Amgen, Inc. v. Chugai for plastic rods that he used because that mode would Pharm. Co., 927 F.2d 1200, 18 USPQ 2d 1016 (Fed. have been employed by those of ordinary skill in the Cir. 1991). art at the time the application was ®led. W.L. Gore & Assoc., Inc. v. Garlock Inc., 721 F.2d 1540, 220 There was held to be no violation of the best mode USPQ 303 (Fed. Cir. 1983). requirement where the Solicitor argued that concealment could be inferred from the disclosure There was no best mode violation where the patentee in a speci®cation that each analog is ªsurprisingly failed to disclose in the speci®cation ª[k]nown ways and unexpectedly more useful than one of the to perform a known operationº to practice the corresponding prostaglandins . . . for at least one of

2100-281 Rev. 07.2015, October 2015 § 2166 MANUAL OF PATENT EXAMINING PROCEDURE -2170

Pre-AIA 35 U.S.C. 112 Speci®cation the pharmacological purposes.º It was argued that appellant must have had test results to substantiate ***** this statement and this data should have been disclosed. The court concluded that no withholding The speci®cation shall conclude with one or more claims particularly pointing out and distinctly claiming the subject could be inferred from general statements of matter which the applicant regards as his invention. increased selectivity and narrower spectrum of ***** potency for these novel analogs, conclusions which could be drawn from the elementary pharmacological Two separate requirements are set forth in 35 U.S.C. testing of the analogs. In re Bundy, 642 F.2d 430, 112(b) and pre-AIA 35 U.S.C. 112, second 435, 209 USPQ 48, 52 (CCPA 1981). paragraph, namely that:

II. EXAMPLES Ð BEST MODE REQUIREMENT (A) the claims must set forth the subject matter NOT SATISFIED that the inventor or a joint inventor regards as the invention; and The best mode requirement was held to be violated (B) the claims must particularly point out and where inventors of a laser failed to disclose details distinctly de®ne the metes and bounds of the subject of their preferred TiCuSil brazing method which matter to be protected by the patent grant. were not contained in the prior art and were contrary to criteria for the use of TiCuSil as contained in the The ®rst requirement is a subjective one because it literature. Spectra-Physics, Inc. v. Coherent, Inc., is dependent on what the inventor or a joint inventor 827 F.2d 1524, 3 USPQ 2d 1737 (Fed. Cir. 1987). for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, The best mode requirement was violated because an uses the phrase "which applicant regards as his inventor failed to disclose whether to use a speci®c invention," pre-AIA 37 CFR 1.41(a) provides that surface treatment that he knew was necessary to the a patent is applied for in the name or names of the satisfactory performance of his invention, even actual inventor or inventors. though how to perform the treatment itself was known in the art. The argument that the best mode The second requirement is an objective one because requirement may be met solely by reference to what it is not dependent on the views of the inventor or was known in the prior art was rejected as incorrect. any particular individual, but is evaluated in the Dana Corp. v. IPC Ltd. P©ship, 860 F.2d 415, context of whether the claim is de®nite Ð i.e., 8 USPQ2d 1692 (Fed. Cir. 1988). whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of 2166 skill in the pertinent art. -2170 [Reserved] Although an essential purpose of the examination process is to determine whether or not the claims de®ne an invention that is both novel and 2171 Two Separate Requirements for Claims nonobvious over the prior art, another essential Under 35 U.S.C. 112 (b) or Pre-AIA 35 U.S.C. purpose of patent examination is to determine 112, Second Paragraph [R-11.2013] whether or not the claims are precise, clear, correct, and unambiguous. The uncertainties of claim scope 35 U.S.C. 112 Speci®cation should be removed, as much as possible, during the ***** examination process.

(b) CONCLUSION.ÐThe speci®cation shall conclude with one or more claims particularly pointing out and distinctly The inquiry during examination is patentability of claiming the subject matter which the inventor or a joint inventor the invention as the inventor or a joint inventor regards as the invention. regards it. If the claims do not particularly point out ***** and distinctly claim that which the inventor or a joint inventor regards as his or her invention, the

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appropriate action by the examiner is to reject the is irrelevant to compliance with the 35 U.S.C. 112(b) claims under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. or pre-AIA 35 U.S.C. 112, second paragraph. 112, second paragraph. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989). If a rejection is III. SHIFT IN CLAIMS PERMITTED based on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, the examiner should further 35 U.S.C. 112(b) or the second paragraph of pre-AIA explain whether the rejection is based on 35 U.S.C. 112 does not prohibit the inventor or a inde®niteness or on the failure to claim what the joint inventor from changing what he or she regards inventor or a joint invention regards as the invention. as the invention during the pendency of the Ex parte Ionescu, 222 USPQ 537, 539 (Bd. Pat. application. In re Saunders, 444 F.2d 599, 170 App. & Inter. 1984). USPQ 213 (CCPA 1971) (permitting claims and submission of comparative evidence with respect to 2172 Subject Matter Which the Inventor or claimed subject matter which originally was only a Joint Inventor Regards as The Invention the preferred embodiment within much broader [R-11.2013] claims (directed to a method)). The fact that claims in a continuation application were directed to I. FOCUS FOR EXAMINATION originally disclosed subject matter which had not been regarded as part of the invention when the A rejection based on the failure to satisfy this parent application was ®led was held not to prevent requirement is appropriate only where an inventor the continuation application from receiving bene®ts has stated, somewhere other than in the application of the ®ling date of the parent application under 35 as ®led, that the invention is something different U.S.C. 120. In re Brower, 433 F.2d 813, 167 USPQ from what is de®ned by the claims. In other words, 684 (CCPA 1970). the invention set forth in the claims must be presumed, in the absence of evidence to the contrary, 2172.01 Unclaimed Essential Matter to be that which the inventor or a joint inventor [R-11.2013] regards as the invention. In re Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971). A claim which omits matter disclosed to be essential to the invention as described in the speci®cation or II. EVIDENCE TO THE CONTRARY in other statements of record may be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst Evidence that shows that a claim does not correspond paragraph, as not enabling. In re Mayhew, 527 F.2d in scope with that which an inventor regards as an 1229, 188 USPQ 356 (CCPA 1976). See also MPEP inventor's invention may be found, for example, in § 2164.08(c). Such essential matter may include contentions or admissions contained in briefs or missing elements, steps or necessary structural remarks ®led by applicant (see e.g., Solomon v. cooperative relationships of elements described by Kimberly-Clark Corp., 216 F.3d 1372, 55 USPQ2d the applicant(s) as necessary to practice the 1279 (Fed. Cir. 2000) and In re Prater, 415 F.2d invention. 1393, 162 USPQ 541 (CCPA 1969)), or in af®davits ®led under 37 CFR 1.132 (see, e.g., In re Cormany, In addition, a claim which fails to interrelate essential 476 F.2d 998, 177 USPQ 450 (CCPA 1973)). The elements of the invention as de®ned by applicant(s) content of the speci®cation is not used as evidence in the speci®cation may be rejected under 35 U.S.C. that the scope of the claims is inconsistent with the 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, subject matter which an inventor regards as his or for failure to point out and distinctly claim the her invention. As noted in In re Ehrreich, 590 F.2d invention. See In re Venezia, 530 F.2d 956, 189 902, 200 USPQ 504 (CCPA 1979), agreement, or USPQ 149 (CCPA 1976); In re Collier, 397 F.2d lack thereof, between the claims and the speci®cation 1003, 158 USPQ 266 (CCPA 1968). But see Ex is properly considered only with respect to 35 U.S.C. parte Nolden, 149 USPQ 378, 380 (Bd. Pat. App. & 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph; it Inter. 1965) (ª[I]t is not essential to a patentable combination that there be interdependency between

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the elements of the claimed device or that all the It is of utmost importance that patents issue with elements operate concurrently toward the desired de®nite claims that clearly and precisely inform resultº); Ex parte Huber, 148 USPQ 447, 448-49 persons skilled in the art of the boundaries of (Bd. Pat. App. & Inter. 1965) (A claim does not protected subject matter. Therefore, claims that do necessarily fail to comply with 35 U.S.C. 112, not meet this standard must be rejected under 35 second paragraph where the various elements do not U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second function simultaneously, are not directly functionally paragraph as inde®nite. Such a rejection requires related, do not directly intercooperate, and/or serve that the applicant respond by explaining why the independent purposes.). language is de®nite or by amending the claim, thus making the record clear regarding the claim 2173 Claims Must Particularly Point Out boundaries prior to issuance. As an inde®niteness and Distinctly Claim the Invention rejection requires the applicant to respond by [R-11.2013] explaining why the language is de®nite or by amending the claim, such rejections must clearly identify the language that causes the claim to be Optimizing patent quality by providing clear notice inde®nite and thoroughly explain the reasoning for to the public of the boundaries of the inventive the rejection. subject matter protected by a patent grant fosters innovation and competitiveness. Accordingly, providing high quality patents is one of the agency's 2173.01 Interpreting the Claims [R-07.2015] guiding principles. The Of®ce recognizes that issuing patents with clear and de®nite claim language is a [Editor Note: This MPEP section is applicable to key component to enhancing the quality of patents applications subject to the ®rst inventor to ®le and raising con®dence in the patent process. (FITF) provisions of the AIA except that the relevant date is the "effective ®ling date" of the claimed 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second invention instead of the "time of the invention," paragraph requires that a patent application which is only applicable to applications subject to speci®cation shall conclude with one or more claims pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) particularly pointing out and distinctly claiming the and MPEP § 2150 et seq.] subject matter which the applicant regards as his or her invention. In patent examining parlance, the A fundamental principle contained in 35 U.S.C. claim language must be ªde®niteº to comply with35 112(b) or pre-AIA 35 U.S.C. 112, second paragraph U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second is that applicants are their own lexicographers. They paragraph. Conversely, a claim that does not comply can de®ne in the claims what they regard as their with this requirement of 35 U.S.C. 112(b) or pre-AIA invention essentially in whatever terms they choose 35 U.S.C. 112, second paragraph is ªinde®nite.º so long as any special meaning assigned to a term is clearly set forth in the speci®cation. See MPEP § The primary purpose of this requirement of 2111.01. Applicant may use functional language, de®niteness of claim language is to ensure that the alternative expressions, negative limitations, or any scope of the claims is clear so the public is informed style of expression or format of claim which makes of the boundaries of what constitutes infringement clear the boundaries of the subject matter for which of the patent. A secondary purpose is to provide a protection is sought. As noted by the court in In re clear measure of what applicants regard as the Swinehart, 439 F.2d 210, 160 USPQ 226 (CCPA invention so that it can be determined whether the 1971), a claim may not be rejected solely because claimed invention meets all the criteria for of the type of language used to de®ne the subject patentability and whether the speci®cation meets the matter for which patent protection is sought. criteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph with respect to the claimed I. BROADEST REASONABLE INTERPRETATION invention. The ®rst step to examining a claim to determine if the language is de®nite is to fully understand the

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subject matter of the invention disclosed in the customary meaning may be rebutted by the applicant application and to ascertain the boundaries of that by clearly setting forth a different de®nition of the subject matter encompassed by the claim. During term in the speci®cation. In re Morris, 127 F.3d examination, a claim must be given its broadest 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. 1997) reasonable interpretation consistent with the (the USPTO looks to the ordinary use of the claim speci®cation as it would be interpreted by one of terms taking into account de®nitions or other ordinary skill in the art. Because the applicant has ªenlightenmentº contained in the written the opportunity to amend claims during prosecution, description); But c.f. In re Am. Acad. of Sci. Tech. giving a claim its broadest reasonable interpretation Ctr., 367 F.3d 1359, 1369, 70 USPQ2d 1827, 1834 will reduce the possibility that the claim, once issued, (Fed. Cir. 2004) (ªWe have cautioned against reading will be interpreted more broadly than is justi®ed. In limitations into a claim from the preferred re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984); embodiment described in the speci®cation, even if In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, it is the only embodiment described, absent clear 1322 (Fed. Cir. 1989) (ªDuring patent examination disclaimer in the speci®cation.º); In re Bigio, 381 the pending claims must be interpreted as broadly F.3d 1320, 1325, 72 USPQ2d 1209, 1211 (Fed. Cir. as their terms reasonably allow.º). The focus of the 2004) (The claims at issue were drawn to a ªhair inquiry regarding the meaning of a claim should be brush.º The Court upheld the Board's refusal to what would be reasonable from the perspective of import from the speci®cation a limitation that would one of ordinary skill in the art. In re Suitco Surface, apply the term only to hairbrushes for the scalp. Inc., 603 F.3d 1255, 1260, 94 USPQ2D 1640, 1644 ª[T]his court counsels the PTO to avoid the (Fed. Cir. 2010); In re Buszard, 504 F.3d 1364, 84 temptation to limit broad claim terms solely on the USPQ2d 1749 (Fed. Cir. 2007). In Buszard, the basis of speci®cation passages. Absent claim claim was directed to a ¯ame retardant composition language carrying a narrow meaning, the PTO should comprising a ¯exible polyurethane foam reaction only limit the claim based on the speci®cation or mixture. Buszard, 504 F.3d at 1365, 84 USPQ2d at prosecution history when those sources expressly 1749. The Federal Circuit found that the Board's disclaim the broader de®nition.º). When the interpretation that equated a ª¯exibleº foam with a speci®cation sets a clear path to the claim language, crushed ªrigidº foam was not reasonable. Id. at the scope of the claims is more easily determined 1367, 84 USPQ2d at 1751. Persuasive argument was and the public notice function of the claims is best presented that persons experienced in the ®eld of served. See MPEP § 2111.01 for a full discussion polyurethane foams know that a ¯exible mixture is of the plain meaning of claim language. different than a rigid foam mixture. Id. at 1366, 84 USPQ2d at 1751. See MPEP § 2111 for a full II. DETERMINE WHETHER OR NOT EACH discussion of broadest reasonable interpretation. CLAIM LIMITATION INVOKES 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, sixth paragraph Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, As part of the claim interpretation analysis, unless such meaning is inconsistent with the examiners should determine whether each limitation speci®cation. The plain meaning of a term means invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, the ordinary and customary meaning given to the sixth paragraph or not. If the claim limitation invokes term by those of ordinary skill in the art at the time 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth of the invention. The ordinary and customary paragraph, the claim limitation must ªbe construed meaning of a term may be evidenced by a variety of to cover the corresponding structure, material, or sources, including the words of the claims acts described in the speci®cation and equivalents themselves, the speci®cation, drawings, and prior thereof.º 35 U.S.C. 112(f) and pre-AIA 35 U.S.C. art. However, the best source for determining the 112, sixth paragraph; see also In re Donaldson Co., meaning of a claim term is the speci®cation - the 16 F.3d 1189, 1193 (Fed. Cir. 1994) (en banc) greatest clarity is obtained when the speci®cation (ª[W]e hold that paragraph six applies regardless of serves as a glossary for the claim terms. The the context in which the interpretation of presumption that a term is given its ordinary and means-plus-function language arises, i.e., whether

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as part of a patentability determination in the PTO Inc., 806 F.2d 1565, 1 USPQ2d 1081 (Fed. Cir. or as part of a validity or infringement determination 1986). In Orthokinetics, a claim directed to a wheel in a court.º). See MPEP § 2181, subsection I. for chair included the phrase ªso dimensioned as to be more information regarding the determination of insertable through the space between the doorframe whether a limitation invokes 35 U.S.C. 112(f) or of an automobile and one of the seats thereof.º 806 pre-AIA 35 U.S.C. 112, sixth paragraph, and means- F.2d at 1568, 1 USPQ2d at 1082. The court found (or step-) plus- function claim limitations. the phrase to be as accurate as the subject matter permits, since automobiles are of various sizes. Id. 2173.02 Determining Whether Claim at 1576, 1 USPQ2d at 1088. ªAs long as those of Language is De®nite [R-07.2015] ordinary skill in the art realized the dimensions could be easily obtained, § 112, 2d para. requires nothing [Editor Note: This MPEP section is applicable to more.º Id. Claim terms are typically given their applications subject to the ®rst inventor to ®le ordinary and customary meaning as understood by (FITF) provisions of the AIA except that the relevant one of ordinary skill in the pertinent art, and the date is the "effective ®ling date" of the claimed generally understood meaning of particular terms invention instead of the "time the invention was may vary from art to art. Therefore, it is important made," which is only applicable to applications to analyze claim terms in view of the application's subject to pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 speci®cation from the perspective of those skilled (note) and MPEP § 2150 et seq.] in the relevant art since a particular term used in one patent or application may not have the same meaning when used in a different application. Medrad, Inc. During prosecution, applicant has an opportunity v. MRI Devices Corp., 401 F.3d 1313, 1318, 74 and a duty to amend ambiguous claims to clearly USPQ2d 1184, 1188 (Fed. Cir. 2005). and precisely de®ne the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee's right to exclude. I. CLAIMS UNDER EXAMINATION ARE CONSTRUED DIFFERENTLY THAN PATENTED See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. CLAIMS Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Patented claims are not given the broadest reasonable Circuit stated in Halliburton Energy Servs., Inc. v. interpretation during court proceedings involving M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, infringement and validity, and can be interpreted 1663 (Fed. Cir. 2008): based on a fully developed prosecution record. While "absolute precision is unattainable" in patented We note that the patent drafter is in the best claims, the de®niteness requirement "mandates position to resolve the ambiguity in the patent clarity." Nautilus, Inc. v. Biosig Instruments, Inc., claims, and it is highly desirable that patent 527 U.S. __, 134 S. Ct. 2120, 2129, 110 USPQ2d examiners demand that applicants do so in 1688, 1693 (2014). A court will not ®nd a patented appropriate circumstances so that the patent claim inde®nite unless the claim interpreted in light can be amended during prosecution rather than of the speci®cation and the prosecution history fails attempting to resolve the ambiguity in to "inform those skilled in the art about the scope of litigation. the invention with reasonable certainty." Id. at 1689.

A decision on whether a claim is inde®nite under The Of®ce does not interpret claims when examining 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second patent applications in the same manner as the courts. paragraph requires a determination of whether those In re Packard, 751 F.3d 1307, 1312, 110 USPQ2d skilled in the art would understand what is claimed 1785, 1788 (Fed. Cir. 2014); In re Morris, 127 F.3d when the claim is read in light of the speci®cation. 1048, 1054, 44 USPQ2d 1023, 1028 (Fed. Cir. Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1997); In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1343, 1350, 94 USPQ2d 1241, 1245 (Fed. Cir. 1989). The Of®ce construes claims by giving them 2010); Orthokinetics, Inc. v. Safety Travel Chairs, their broadest reasonable interpretation during

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prosecution in an effort to establish a clear record the language of a claim, given its broadest reasonable of what the applicant intends to claim. Such claim interpretation, is such that a person of ordinary skill construction during prosecution may effectively in the relevant art would read it with more than one result in a lower threshold for ambiguity than a reasonable interpretation, then a rejection under 35 court©s determination. Packard, 751 F.3d at 1323-24, U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second 110 USPQ2d at 1796-97 (Plager, J., concurring). paragraph is appropriate. Examiners, however, are However, applicant has the ability to amend the cautioned against confusing claim breadth with claim claims during prosecution to ensure that the meaning inde®niteness. A broad claim is not inde®nite merely of the language is clear and de®nite prior to issuance because it encompasses a wide scope of subject or provide a persuasive explanation (with evidence matter provided the scope is clearly de®ned. Instead, as necessary) that a person of ordinary skill in the a claim is inde®nite when the boundaries of the art would not consider the claim language unclear. protected subject matter are not clearly delineated In re Buszard, 504 F.3d 1364, 1366 (Fed. Cir. and the scope is unclear. For example, a genus claim 2007)( claims are given their broadest reasonable that covers multiple species is broad, but is not interpretation during prosecution ªto facilitate inde®nite because of its breadth, which is otherwise sharpening and clarifying the claims at the clear. But a genus claim that could be interpreted in application stageº); see also In re Yamamoto, 740 such a way that it is not clear which species are F.2d 1569, 1571 (Fed. Cir. 1984); In re Zletz, 893 covered would be inde®nite (e.g., because there is F.2d 319, 322, 13 USPQ2d 1320, 1322 (Fed. Cir. more than one reasonable interpretation of what 1989). species are included in the claim). See MPEP § 2173.05(h), subsection I., for more information See MPEP § 2111 et seq. for a detailed discussion regarding the determination of whether a Markush of claim interpretation during the examination claim satis®es the requirements of 35 U.S.C. 112(b) process. The lower threshold is also applied because or pre-AIA 35 U.S.C. 112, second paragraph. the patent record is in development and not ®xed during examination, and the agency does not rely II. THRESHOLD REQUIREMENTS OF CLARITY on it for interpreting claims. Packard, 751 F.3d at AND PRECISION 1325 (Plager, J., concurring). Burlington Indus. Inc. v. Quigg, 822 F.2d 1581, 1583, 3 USPQ2d 1436, The examiner's focus during examination of claims 1438 (Fed. Cir. 1987) (ªIssues of judicial claim for compliance with the requirement for de®niteness construction such as arise after patent issuance, for of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, example during infringement litigation, have no second paragraph, is whether the claim meets the place in prosecution of pending claims before the threshold requirements of clarity and precision set PTO, when any ambiguity or excessive breadth may forth in the statute, not whether more suitable be corrected by merely changing the claim.º). language or modes of expression are available. When the examiner is satis®ed that patentable subject During examination, after applying the broadest matter is disclosed, and it is apparent to the examiner reasonable interpretation to the claim, if the metes that the claims are directed to such patentable subject and bounds of the claimed invention are not clear, matter, he or she should allow claims which de®ne the claim is inde®nite and should be rejected. the patentable subject matter with the required degree Packard, 751 F.3d at 1310 (ª[W]hen the USPTO of particularity and distinctness. Some latitude in has initially issued a well-grounded rejection that the manner of expression and the aptness of terms identi®es ways in which language in a claim is should be permitted so long as 35 U.S.C. 112(b) or ambiguous, vague, incoherent, opaque, or otherwise pre-AIA 35 U.S.C. 112, second paragraph, is unclear in describing and de®ning the claimed satis®ed. Examiners are encouraged to suggest claim invention, and thereafter the applicant fails to language to applicants to improve the clarity or provide a satisfactory response, the USPTO can precision of the language used, but should not insist properly reject the claim as failing to meet the on their own preferences if other modes of statutory requirements of § 112(b).º); Zletz, 893 expression selected by applicants satisfy the statutory F.2d at 322, 13 USPQ2d at 1322. For example, if requirement.

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The essential inquiry pertaining to this requirement Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d is whether the claims set out and circumscribe a 1190, 1195 (Fed. Cir. 1993). However, if the particular subject matter with a reasonable degree language used by applicant satis®es the statutory of clarity and particularity. ªAs the statutory requirements of 35 U.S.C. 112(b) or pre-AIA 35 language of `particular[ity]© and ©distinct[ness]© U.S.C. 112, second paragraph, the claim must not indicates, claims are required to be cast in clearÐas be rejected under 35 U.S.C. 112(b) or pre-AIA 35 opposed to ambiguous, vague, inde®niteÐterms. It U.S.C. 112, second paragraph. is the claims that notify the public of what is within the protections of the patent, and what is not.º Examiners should note that Of®ce policy is not to Packard, 751 F.3d at 1313. De®niteness of claim employ per se rules to make technical rejections. language must be analyzed, not in a vacuum, but in Examples of claim language which have been held light of: to be inde®nite set forth in MPEP § 2173.05(d) are fact speci®c and should not be applied as per se (A) The content of the particular application rules. disclosure; (B) The teachings of the prior art; and III. RESOLVING INDEFINITE CLAIM LANGUAGE (C) The claim interpretation that would be given by one possessing the ordinary level of skill in the A. Examiner Must Establish a Clear Record pertinent art at the time the invention was made. In reviewing a claim for compliance with 35 U.S.C. Examiners are urged to carefully carry out their 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, responsibilities to see that the application ®le the examiner must consider the claim as a whole to contains a complete and accurate picture of the determine whether the claim apprises one of ordinary Of®ce's consideration of the patentability of an skill in the art of its scope and, therefore, serves the application. See MPEP § 1302.14, subsection I. In notice function required by 35 U.S.C. 112(b) or order to provide a complete application ®le history pre-AIA 35 U.S.C. 112, second paragraph, by and to enhance the clarity of the prosecution history providing clear warning to others as to what record, an examiner should provide clear constitutes infringement of the patent. See, e.g., explanations of all actions taken during prosecution Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, of the application. See MPEP § 707.07(f). Thus, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). See when a rejection under 35 U.S.C. 112(b) or pre-AIA also In re Larsen, No. 01-1092 (Fed. Cir. May 9, 35 U.S.C. 112, second paragraph, is appropriate 2001) (unpublished) (The preamble of the Larsen based on the examiner's determination that a claim claim recited only a hanger and a loop but the body term or phrase is prima facie inde®nite, the of the claim positively recited a linear member. The examiner should clearly communicate in an Of®ce court observed that the totality of all the limitations action any ®ndings and reasons which support the of the claim and their interaction with each other rejection and avoid a mere conclusion that the claim must be considered to ascertain the inventor's term or phrase is inde®nite. See MPEP § 706.03 and contribution to the art. Upon review of the claim in MPEP § 707.07(g). its entirety, the court concluded that the claim at issue apprises one of ordinary skill in the art of its MPEP § 2173.05 provides numerous examples of scope and, therefore, serves the notice function rationales that may support a rejection under 35 required by 35 U.S.C. 112.). U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, such as functional claim limitations, If the language of the claim is such that a person of relative terminology/terms of degree, lack of ordinary skill in the art could not interpret the metes antecedent basis, etc. Only by providing a complete and bounds of the claim so as to understand how to explanation in the Of®ce action as to the basis for avoid infringement, a rejection of the claim under determining why a particular term or phrase used in 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second the claim is ªvague and inde®niteº will the examiner paragraph, is appropriate. See Morton Int'l, Inc. v. enhance the clarity of the prosecution history record.

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B. An Of®ce Action Should Provide a Suf®cient the administrative process.º Zletz, 893 F.2d at 322, Explanation 13 USPQ2d at 1322.

The Of®ce action must set forth the speci®c term or Accordingly, when rejecting a claim as prima facie phrase that is inde®nite and why the metes and inde®nite under 35 U.S.C. 112(b) or pre-AIA 35 bounds are unclear. Since a rejection requires the U.S.C. 112, second paragraph, the examiner should applicant to respond by explaining why claim provide enough information in the Of®ce action to language would be recognized by a person of permit applicant to make a meaningful response, as ordinary skill in the art as de®nite or by amending the inde®niteness rejection requires the applicant to the claim, the Of®ce action should provide enough explain or provide evidence as to why the claim information for the applicant to prepare a meaningful language is not inde®nite or amend the claim. For response. ªBecause claims delineate the patentee's example, in making a prima facie case of right to exclude, the patent statute requires that the inde®niteness, the examiner should point out the scope of the claims be suf®ciently de®nite to inform speci®c term or phrase that is inde®nite, explain in the public of the bounds of the protected invention, detail why such term or phrase renders the metes i.e., what subject matter is covered by the exclusive and bounds of the claim scope unclear and, whenever rights of the patent.º Halliburton Energy Servs., practicable, indicate how the inde®niteness issues Inc. v. M-I LLC, 514 F.3d 1244, 1249, 85 USPQ2d may be resolved to overcome the rejection. See 1654, 1658 (Fed. Cir. 2008). Thus, claims are given MPEP § 707.07(d). If the applicant does not their broadest reasonable interpretation during adequately respond to the prima facie case, the prosecution ªto facilitate sharpening and clarifying examiner may make the inde®niteness rejection ®nal. the claims at the application stageº when claims are Packard, 751 F.3d at 1312. readily changed. In re Buszard, 504 F.3d 1364, 1366 (Fed. Cir. 2007); see also In re Yamamoto, 740 F.2d The focus during the examination of claims for 1569, 1571 (Fed. Cir. 1984); In re Zletz, 893 F.2d compliance with the requirement for de®niteness 319, 322, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989). under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is whether the claim meets the To comply with 35 U.S.C. 112(b) or pre-AIA 35 threshold requirements of clarity and precision, not U.S.C. 112, second paragraph, applicants are whether more suitable language or modes of required to make the terms that are used to de®ne expression are available. See MPEP § 2173.02, the invention clear and precise, so that the metes and subsection II. Examiners are encouraged to suggest bounds of the subject matter that will be protected claim language to applicants to improve the clarity by the patent grant can be ascertained. See MPEP § or precision of the language used, but should not 2173.05(a), subsection I. It is important that a person insist on their own preferences if other modes of of ordinary skill in the art be able to interpret the expression selected by applicants satisfy the statutory metes and bounds of the claims so as to understand requirement. Furthermore, when the examiner how to avoid infringement of the patent that determines that more information is necessary to ultimately issues from the application being ascertain the meaning of a claim term, a requirement examined. See MPEP § 2173.02, subsection II (citing for information under 37 CFR 1.105 may be Morton Int 'l, Inc. v. Cardinal Chem. Co., 5 F.3d appropriate. See MPEP § 704.10 regarding 1464, 1470 (Fed. Cir. 1993)); see also Halliburton requirements for information. Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (ªOtherwise, competitors cannot avoid infringement, It is highly desirable to have applicants resolve defeating the public notice function of patent ambiguity by amending the claims during claims.º). Examiners should bear in mind that ª[a]n prosecution of the application rather than attempting essential purpose of patent examination is to fashion to resolve the ambiguity in subsequent litigation of claims that are precise, clear, correct, and the issued patent. Halliburton Energy Servs., 514 unambiguous. Only in this way can uncertainties of F.3d at 1255. Thus, in response to an examiner's claim scope be removed, as much as possible, during rejection for inde®niteness, an applicant may resolve the ambiguity by amending the claim, or by

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providing a persuasive explanation on the record equivalent in question.º Id. at 1842, 62 USPQ2d at that a person of ordinary skill in the relevant art 1713. Thus, whenever possible, the examiner should would not consider the claim language unclear. In make the record clear by providing explicit reasoning re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014). for making or withdrawing any rejection related to For the latter option, in some cases, it may be 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second necessary for the applicant to provide a separate paragraph. de®nition (such as from an art-recognized dictionary) to show how the ordinarily-skilled artisan would C. Provide Claim Interpretation in Reasons for have understood the claim language at issue. Id. Allowance When Record is Unclear

If the examiner considers applicant's arguments Pursuant to 37 CFR 1.104(e), if the examiner and/or amendments to be persuasive, the examiner believes that the record of the prosecution as a whole should indicate in the next Of®ce communication does not make clear his or her reasons for allowing that the previous rejection under 35 U.S.C. 112(b) a claim or claims, the examiner may set forth such or pre-AIA 35 U.S.C. 112, second paragraph, has reasoning in reasons for allowance. Further, prior to been withdrawn and provide an explanation as to allowance, the examiner may also specify allowable what prompted the change in the examiner's position subject matter and provide reasons for indicating (e.g., by making speci®c reference to portions of such allowable subject matter in an Of®ce applicant's remarks). communication. See MPEP § 1302.14, subsection I. One of the primary purposes of 37 CFR 1.104(e) By providing an explanation as to the action taken, is to improve the quality and reliability of issued the examiner will enhance the clarity of the patents by providing a complete ®le history which prosecution history record. As noted by the Supreme should clearly re¯ect the reasons why the application Court in Festo Corp. v. Shoketsu Kinzoku Kogyo was allowed. Such information facilitates evaluation Kabushiki Co., 535 U.S. 722, 122 S.Ct. 1831, 1838, of the scope and strength of a patent by the patentee 62 USPQ2d 1705, 1710 (2002), a clear and complete and the public and may help avoid or simplify prosecution ®le record is important in that subsequent litigation of an issued patent. See MPEP ª[p]rosecution history estoppel requires that the § 1302.14, subsection I. In meeting the need for the claims of a patent be interpreted in light of the application ®le history to speak for itself, it is proceedings in the PTO during the application incumbent upon the examiner in exercising his or process.º In Festo, the court held that ªa narrowing her responsibility to the public to see that the ®le amendment made to satisfy any requirement of the history is complete. See MPEP § 1302.14, subsection Patent Act may give rise to an estoppel.º With I. respect to amendments made to comply with the requirements of 35 U.S.C. 112, the court stated that For example, when allowing a claim based on a ª[i]f a § 112 amendment is truly cosmetic, then it claim interpretation which might not be readily would not narrow the patent's scope or raise an apparent from the record of the prosecution as a estoppel. On the other hand, if a § 112 amendment whole, the examiner should set forth in reasons for is necessary and narrows the patent's scopeÐeven allowance the claim interpretation that he or she if only for the purpose of better applied in determining that the claim is allowable descriptionÐestoppel may apply.º Id. at 1840, 62 over the prior art. See MPEP § 1302.14, subsection USPQ2d at 1712. The court further stated that ªwhen II.G. This is especially the case where the application the court is unable to determine the purpose is allowed after an interview. The examiner should underlying a narrowing amendmentÐand hence a ensure, however, that statements of reasons for rationale for limiting the estoppel to the surrender allowance do not place unwarranted interpretations, of particular equivalentsÐthe court should presume whether broad or narrow, upon the claims. See that the patentee surrendered all subject matter MPEP § 1302.14, subsection I. between the broader and the narrower language¼the patentee should bear the burden of showing that the D. Open Lines of Communication with the Applicant amendment does not surrender the particular ± When Inde®niteness Is the Only Issue, Attempt

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Resolution through an Interview before Resorting to a claim amendments discussed that would resolve Rejection identi®ed ambiguities.

Examiners are reminded that interviews can be an 2173.03 Correspondence Between effective examination tool and are encouraged to Speci®cation and Claims [R-07.2015] initiate an interview with the applicant or applicant's representative at any point during the pendency of The speci®cation should ideally serve as a glossary an application, if the interview can help further to the claim terms so that the examiner and the public prosecution, shorten pendency, or provide a bene®t can clearly ascertain the meaning of the claim terms. to the examiner or applicant. Issues of claim Correspondence between the speci®cation and claims interpretation and clarity of scope may lend is required by 37 CFR 1.75(d)(1), which provides themselves to resolution through an examiner that claim terms must ®nd clear support or interview. For example, the examiner may initiate antecedent basis in the speci®cation so that the an interview to discuss, among other issues, the meaning of the terms may be ascertainable by broadest reasonable interpretation of a claim, the reference to the speci®cation. Glossaries of terms meaning of a particular claim limitation, and the used in the claims are a helpful device for ensuring scope and clarity of preamble language, functional adequate de®nition of terms used in claims. If the language, intended use language, and speci®cation does not provide the needed support means-plus-function limitations, etc. or antecedent basis for the claim terms, the speci®cation should be objected to under 37 CFR An interview can serve to develop and clarify such 1.75(d)(1). See MPEP § 608.01(o) and MPEP § issues and lead to a mutual understanding between 2181, subsection IV. Applicant will be required to the examiner and the applicant, potentially make appropriate amendment to the description to eliminating the need for the examiner to resort to provide clear support or antecedent basis for the making a rejection under 35 U.S.C. 112(b) or claim terms provided no new matter is introduced, pre-AIA 35 U.S.C. 112, second paragraph. The or amend the claim. examiner is reminded that the substance of any interview, whether in person, by video conference, A claim, although clear on its face, may also be or by telephone must be made of record in the inde®nite when a con¯ict or inconsistency between application, whether or not an agreement was the claimed subject matter and the speci®cation reached at the interview. See MPEP § 713.04; see disclosure renders the scope of the claim uncertain also 37 CFR 1.2 (ªThe action of the Patent and as inconsistency with the speci®cation disclosure or Trademark Of®ce will be based exclusively on the prior art teachings may make an otherwise de®nite written record in the Of®ce. No attention will be claim take on an unreasonable degree of uncertainty. paid to any alleged oral promise, stipulation, or In re Moore, 439 F.2d 1232, 1235-36 (CCPA 1971); understanding in relation to which there is In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA disagreement or doubt.º). Examples of 35 U.S.C. 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 112 issues that should be made of record after the 204 (CCPA 1970). For example, a claim with a interview include: why the discussed claim term is limitation of ªthe clamp means including a clamp or is not suf®ciently clear; why the discussed claim body and ®rst and second clamping members, the term is or is not inconsistent with the speci®cation; clamping members being supported by the clamp why the discussed claim term does or does not bodyº was determined to be inde®nite because the invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, terms ª®rst and second clamping membersº and sixth paragraph (and if it does, the identi®cation of ªclamp bodyº were found to be vague in light of the corresponding structure, material, or acts in the speci®cation which showed no ªclamp memberº speci®cation for a 35 U.S.C. 112(f) or pre-AIA 35 structure being ªsupported by the clamp body.º In U.S.C. 112, sixth paragraph limitation); and any re Anderson, 1997 U.S. App. Lexis 167 (Fed. Cir. January 6, 1997) (unpublished). In Cohn, a claim was directed to a process of treating an aluminum surface with an alkali silicate solution and included

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a further limitation that the surface has an ªopaqueº because it reads on the prior art, a rejection under appearance. Id. The speci®cation, meanwhile, either 35 U.S.C. 102 or 103 would be appropriate. associated the use of an alkali silicate with a glazed or porcelain-like ®nish, which the speci®cation 2173.05 Speci®c Topics Related to Issues distinguished from an opaque ®nish. Cohn, 438 Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. F.2d at 993. Noting that no claim may be read apart 112, Second Paragraph [R-11.2013] from and independent of the supporting disclosure on which it is based, the court found that the claim The following sections are devoted to a discussion was internally inconsistent based on the description, of speci®c topics where issues under 35 U.S.C. de®nitions and examples set forth in the speci®cation 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, relating to the appearance of the surface after have been addressed. These sections are not intended treatment, and therefore inde®nite. Id. to be an exhaustive list of the issues that can arise under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 2173.04 Breadth Is Not Inde®niteness second paragraph, but are intended to provide [R-07.2015] guidance in areas that have been addressed with some frequency in recent examination practice. The Breadth of a claim is not to be equated with court and Board decisions cited are representative. inde®niteness. In re Miller, 441 F.2d 689, 169 As with all appellate decisions, the results are largely USPQ 597 (CCPA 1971); In re Gardner, 427 F.2d dictated by the facts in each case. The use of the 786, 788, 166 USPQ 138, 140 (CCPA 1970) same language in a different context may justify a ("Breadth is not inde®niteness."). A broad claim is different result. not inde®nite merely because it encompasses a wide scope of subject matter provided the scope is clearly See MPEP § 2181 for guidance in de®ned. But a claim is inde®nite when the determining whether an applicant has complied with boundaries of the protected subject matter are not the requirements of 35 U.S.C. 112(b) or pre-AIA 35 clearly delineated and the scope is unclear. For U.S.C. 112, second paragraph, when 35 U.S.C. example, a genus claim that covers multiple species 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is broad, but is not inde®nite because of its breadth, is invoked. which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear 2173.05(a) New Terminology [R-07.2015] which species are covered would be inde®nite (e.g., because there is more than one reasonable I. THE MEANING OF EVERY TERM SHOULD BE interpretation of what species are included in the APPARENT claim). The meaning of every term used in a claim should Undue breadth of the claim may be addressed under be apparent from the prior art or from the different statutory provisions, depending on the speci®cation and drawings at the time the application reasons for concluding that the claim is too broad. is ®led. Claim language may not be ªambiguous, If the claim is too broad because it does not set forth vague, incoherent, opaque, or otherwise unclear in that which applicants regard as their invention as describing and de®ning the claimed invention.º evidenced by statements outside of the application Packard, 751 F.3d at 1311. Applicants need not as ®led, a rejection under 35 U.S.C. 112(b) or con®ne themselves to the terminology used in the pre-AIA 35 U.S.C. 112, second paragraph, would prior art, but are required to make clear and precise be appropriate. If the claim is too broad because it the terms that are used to de®ne the invention is not supported by the original description or by an whereby the metes and bounds of the claimed enabling disclosure, a rejection under 35 U.S.C. invention can be ascertained. During patent 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, examination, the pending claims must be given the would be appropriate. If the claim is too broad broadest reasonable interpretation consistent with the speci®cation. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re

Rev. 07.2015, October 2015 2100-292 PATENTABILITY § 2173.05(b)

Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA her own lexicographer, a patentee or applicant may 1969). See also MPEP § 2111 - § 2111.01. When use terms in a manner contrary to or inconsistent the speci®cation states the meaning that a term in with one or more of their ordinary meanings if the the claim is intended to have, the claim is examined written description clearly rede®nes the terms. See, using that meaning, in order to achieve a complete e.g., Process Control Corp. v. HydReclaim Corp., exploration of the applicant's invention and its 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. relation to the prior art. In re Zletz, 893 F.2d 319, Cir. 1999) (ªWhile we have held many times that a 13 USPQ2d 1320 (Fed. Cir. 1989). patentee can act as his own lexicographer to speci®cally de®ne terms of a claim contrary to their II. THE REQUIREMENT FOR CLARITY AND ordinary meaning,º in such a situation the written PRECISION MUST BE BALANCED WITH THE description must clearly rede®ne a claim term ªso LIMITATIONS OF THE LANGUAGE as to put a reasonable competitor or one reasonably skilled in the art on notice that the patentee intended Courts have recognized that it is not only to so rede®ne that claim term.º); Hormone Research permissible, but often desirable, to use new terms Foundation Inc. v. Genentech Inc., 904 F.2d 1558, that are frequently more precise in describing and 15 USPQ2d 1039 (Fed. Cir. 1990). Accordingly, de®ning the new invention. In re Fisher, 427 F.2d when there is more than one meaning for a term, it 833, 166 USPQ 18 (CCPA 1970). Although it is is incumbent upon applicant to make clear which dif®cult to compare the claimed invention with the meaning is being relied upon to claim the invention. prior art when new terms are used that do not appear Until the meaning of a term or phrase used in a claim in the prior art, this does not make the new terms is clear, a rejection under 35 U.S.C. 112(b) or inde®nite. pre-AIA 35 U.S.C. 112, second paragraph is appropriate. It is appropriate to compare the meaning New terms are often used when a new technology of terms given in technical dictionaries in order to is in its infancy or is rapidly evolving. The ascertain the accepted meaning of a term in the art. requirements for clarity and precision must be In re Barr, 444 F.2d 588, 170 USPQ 330 (CCPA balanced with the limitations of the language and 1971). See also MPEP § 2111.01. the science. If the claims, read in light of the speci®cation, reasonably apprise those skilled in the 2173.05(b) Relative Terminology [R-07.2015] art both of the utilization and scope of the invention, and if the language is as precise as the subject matter The use of relative terminology in claim language, permits, the statute (35 U.S.C. 112(b) or pre-AIA including terms of degree, does not automatically 35 U.S.C. 112, second paragraph) demands no more. render the claim inde®nite under 35 U.S.C. 112(b) Packard, 751 F.3d at 1313 (ª[H]ow much clarity is or pre-AIA 35 U.S.C. 112, second paragraph. Seattle required necessarily invokes some standard of Box Co., Inc. v. Industrial Crating & Packing, Inc., reasonable precision in the use of language in the 731 F.2d 818, 221 USPQ 568 (Fed. Cir. 1984). context of the circumstances.º). This does not mean Acceptability of the claim language depends on that the examiner must accept the best effort of whether one of ordinary skill in the art would applicant. If the language is not considered as precise understand what is claimed, in light of the as the subject matter permits, the examiner should speci®cation. provide reasons to support the conclusion of inde®niteness and is encouraged to suggest I. TERMS OF DEGREE alternatives that would not be subject to rejection. Terms of degree are not necessarily inde®nite. III. TERMS USED CONTRARY TO THEIR ªClaim language employing terms of degree has ORDINARY MEANING MUST BE CLEARLY long been found de®nite where it provided enough REDEFINED IN THE WRITTEN DESCRIPTION certainty to one of skill in the art when read in the context of the invention. Interval Licensing LLC v. Consistent with the well-established axiom in patent AOL, Inc., 766 F.3d 1364, 1370, 112 USPQ2d 1188, law that a patentee or applicant is free to be his or 1192-93 (Fed. Cir. 2014) (citing Eibel Process Co.

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v. Minnesota & Ontario Paper Co., 261 U.S. 45, rejection over ªnot interfering substantiallyº claim 65-66 (1923) (®nding `substantial pitch' suf®ciently language by submitting a declaration under 37 CFR de®nite because one skilled in the art `had no 1.132 listing eight speci®c linkage groups that dif®culty ¼ in determining what was the substantial applicant declared did not substantially interfere with pitch needed' to practice the invention)). Thus, when hybridization or detection). a term of degree is used in the claim, the examiner should determine whether the speci®cation provides Even if the speci®cation uses the same term of some standard for measuring that degree. Hearing degree as in the claim, a rejection is proper if the Components, Inc. v. Shure Inc., 600 F.3d 1357, 1367, scope of the term is not understood when read in 94 USPQ2d 1385, 1391 (Fed. Cir. 2010); Enzo light of the speci®cation. While, as a general Biochem, Inc., v. Applera Corp., 599 F.3d 1325, proposition, broadening modi®ers are standard tools 1332, 94 USPQ2d 1321, 1326 (Fed. Cir. 2010); in claim drafting in order to avoid reliance on the Seattle Box Co., Inc. v. Indus. Crating & Packing, doctrine of equivalents in infringement actions, when Inc., 731 F.2d 818, 826, 221 USPQ 568, 574 (Fed. the scope of the claim is unclear a rejection under Cir. 1984). If the speci®cation does not provide some 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second standard for measuring that degree, a determination paragraph, is proper. See In re Wiggins, 488 F. 2d must be made as to whether one of ordinary skill in 538, 541, 179 USPQ 421, 423 (CCPA 1973). the art could nevertheless ascertain the scope of the claim (e.g., a standard that is recognized in the art When relative terms are used in claims wherein the for measuring the meaning of the term of degree). improvement over the prior art rests entirely upon For example, in Ex parte Oetiker, 23 USPQ2d 1641 size or weight of an element in a combination of (Bd. Pat. App. & Inter. 1992), the phrases ªrelatively elements, the adequacy of the disclosure of a shallow,º ªof the order of,º ªthe order of about standard is of greater criticality. 5mm,º and ªsubstantial portionº were held to be inde®nite because the speci®cation lacked some II. REFERENCE TO AN OBJECT THAT IS standard for measuring the degrees intended. VARIABLE MAY RENDER A CLAIM INDEFINITE

The claim is not inde®nite if the speci®cation A claim may be rendered inde®nite by reference to provides examples or teachings that can be used to an object that is variable. See, e.g., Ex parte measure a degree even without a precise numerical Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. measurement (e.g., a ®gure that provides a standard 2008) (precedential) and Ex parte Brummer, 12 for measuring the meaning of the term of degree). USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). In See, e.g., Interval Licensing LLC v. AOL, Inc., 766 Miyazaki, the Board held that claims to a large F.3d 1364, 1371-72, 112 USPQ2d 1188, 1193 (Fed. printer were not suf®ciently de®nite because: Cir. 2014) (observing that although there is no absolute or mathematical precision required, ª[t]he The language of claim 1 attempts to claim the claims, when read in light of the speci®cation and height of the paper feeding unit in relation to a the prosecution history, must provide objective user of a speci®c height who is performing boundaries for those of skill in the artº). operations on the printer.... Claim 1 fails to specify, however, a positional relationship of During prosecution, an applicant may also overcome the user and the printer to each other. an inde®niteness rejection by providing evidence that the meaning of the term of degree can be ascertained by one of ordinary skill in the art when Miyazaki, 89 USPQ2d at 1212. In Brummer, the reading the disclosure. For example, in Enzo Board held that a limitation in a claim to a bicycle Biochem, the applicant submitted a declaration that recited ªsaid front and rear wheels so spaced as under 37 CFR 1.132 showing examples that met the to give a wheelbase that is between 58 percent and claim limitation and examples that did not. Enzo 75 percent of the height of the rider that the bicycle Biochem, 599 F.3d at 1335, 94 USPQ2d at 1328 was designed forº was inde®nite because the (noting that applicant overcame an inde®niteness relationship of parts was not based on any known

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standard for sizing a bicycle to a rider, but on a rider starting materials and essential ingredients. In of unspeci®ed build. Brummer, 12 USPQ2d at 1655. re Marosi, 710 F.2d 799, 218 USPQ 289 (CCPA 1983). The court further observed that it would be On the other hand, a claim limitation specifying that impractical to require applicants to specify a a certain part of a pediatric wheelchair be ªso particular number as a cutoff between their invention dimensioned as to be insertable through the space and the prior art. between the doorframe of an automobile and one of the seatsº was held to be de®nite. Orthokinetics, C. ªSimilarº Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1 USPQ2d 1081 (Fed. Cir. 1986). The court stated that The term ªsimilarº in the preamble of a claim that the phrase ªso dimensionedº is as accurate as the was directed to a nozzle ªfor high-pressure cleaning subject matter permits, noting that the patent law units or similar apparatusº was held to be inde®nite does not require that all possible lengths since it was not clear what applicant intended to corresponding to the spaces in hundreds of different cover by the recitation ªsimilarº apparatus. Ex automobiles be listed in the patent, let alone that parte Kristensen, 10 USPQ2d 1701 (Bd. Pat. App. they be listed in the claims. & Inter. 1989).

III. APPROXIMATIONS A claim in a design patent application which read: ªThe ornamental design for a feed bunk or similar A. ªAboutº structure as shown and described.º was held to be inde®nite because it was unclear from the In determining the range encompassed by the term speci®cation what applicant intended to cover by ªaboutº, one must consider the context of the term the recitation of ªsimilar structure.º Ex as it is used in the speci®cation and claims of the parte Pappas, 23 USPQ2d 1636 (Bd. Pat. App. & application. Ortho-McNeil Pharm., Inc. v. Caraco Inter. 1992). Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). In W.L. Gore D. ªSubstantiallyº & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that The term ªsubstantiallyº is often used in conjunction a limitation de®ning the stretch rate of a plastic as with another term to describe a particular ªexceeding about 10% per secondº is de®nite characteristic of the claimed invention. It is a broad because infringement could clearly be assessed term. In re Nehrenberg, 280 F.2d 161, 126 USPQ through the use of a stopwatch. However, in another 383 (CCPA 1960). The court held that the limitation case, the court held that claims reciting ªat least ªto substantially increase the ef®ciency of the aboutº were invalid for inde®niteness where there compound as a copper extractantº was de®nite in was close prior art and there was nothing in the view of the general guidelines contained in the speci®cation, prosecution history, or the prior art to speci®cation. In re Mattison, 509 F.2d 563, 184 provide any indication as to what range of speci®c USPQ 484 (CCPA 1975). The court held that the activity is covered by the term ªabout.º Amgen, Inc. limitation ªwhich produces substantially equal E and v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 H plane illumination patternsº was de®nite because USPQ2d 1016 (Fed. Cir. 1991). one of ordinary skill in the art would know what was meant by ªsubstantially equal.º Andrew B. ªEssentiallyº Corp. v. Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir. 1988). The phrase ªa silicon dioxide source that is essentially free of alkali metalº was held to be E. ªTypeº de®nite because the speci®cation contained guidelines and examples that were considered The addition of the word ªtypeº to an otherwise suf®cient to enable a person of ordinary skill in the de®nite expression (e.g., Friedel-Crafts catalyst) art to draw a line between unavoidable impurities in extends the scope of the expression so as to render

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it inde®nite. Ex parte Copenhaver, 109 USPQ 118 and ªsuperiorº were held to be inde®nite in the (Bd. Pat. App. & Inter. 1955). Likewise, the phrase context of a limitation relating the characteristics of ªZSM-5-type aluminosilicate zeolitesº was held to the claimed material to other materials). be inde®nite because it was unclear what ªtypeº was intended to convey. The interpretation was made During prosecution, the applicant may overcome a more dif®cult by the fact that the zeolites de®ned in rejection by amending the claim to remove the the dependent claims were not within the genus of subjective term, or by providing evidence that the the type of zeolites de®ned in the independent claim. meaning of the term can be ascertained by one of Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & ordinary skill in the art when reading the disclosure. Inter. 1986). However, ª[f]or some facially subjective terms, the de®niteness requirement is not satis®ed by merely IV. SUBJECTIVE TERMS offering examples that satisfy the term within the speci®cation.º DDR Holdings, LLC v. Hotels.com, When a subjective term is used in the claim, the L.P., 773 F.3d 1245, 1261 (Fed. Cir. 2014). examiner should determine whether the speci®cation supplies some standard for measuring the scope of 2173.05(c) Numerical Ranges and Amounts the term, similar to the analysis for a term of degree. Limitations [R-11.2013] Some objective standard must be provided in order to allow the public to determine the scope of the Generally, the recitation of speci®c numerical ranges claim. A claim that requires the exercise of in a claim does not raise an issue of whether a claim subjective judgment without restriction may render is de®nite. the claim inde®nite. In re Musgrave, 431 F.2d 882, 893 (CCPA 1970). Claim scope cannot depend solely I. NARROW AND BROADER RANGES IN THE on the unrestrained, subjective opinion of a particular SAME CLAIM individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d Use of a narrow numerical range that falls within a 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. broader range in the same claim may render the 2005)); see also Interval Licensing LLC v. AOL, claim inde®nite when the boundaries of the claim Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. are not discernible. Description of examples and Cir. 2014) (holding the claim phrase ªunobtrusive preferences is properly set forth in the speci®cation mannerº inde®nite because the speci®cation did not rather than in a single claim. A narrower range or ªprovide a reasonably clear and exclusive de®nition, preferred embodiment may also be set forth in leaving the facially subjective claim language another independent claim or in a dependent claim. without an objective boundaryº). If stated in a single claim, examples and preferences lead to confusion over the intended scope of the For example, in Datamize, the invention was claim. In those instances where it is not clear whether directed to a computer interface screen with an the claimed narrower range is a limitation, a rejection ªaesthetically pleasing look and feel.º Datamize, under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 417 F.3d at 1344-45. The meaning of the term second paragraph should be made. The Examiner ªaesthetically pleasingº depended solely on the should analyze whether the metes and bounds of the subjective opinion of the person selecting features claim are clearly set forth. Examples of claim to be included on the interface screen. Nothing in language which have been held to be inde®nite are the intrinsic evidence (e.g., the speci®cation) (A) ªa temperature of between 45 and 78 degrees provided any guidance as to what design choices Celsius, preferably between 50 and 60 degrees would result in an ªaesthetically pleasingº look and Celsiusº; and (B) ªa predetermined quantity, for feel. Id. at 1352. The claims were held inde®nite example, the maximum capacity.º because the interface screen may be ªaesthetically pleasingº to one user but not to another. Id. at 1350. While a single claim that includes both a broad and See also Ex parte Anderson, 21 USPQ2d 1241 (Bd. a narrower range may be inde®nite, it is not improper Pat. App. & Inter. 1991) (the terms ªcomparableº under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C.112,

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second paragraph, to present a dependent claim that reported cases: the term ªup toº includes zero as a sets forth a narrower range for an element than the lower limit, In re Mochel, 470 F.2d 638, 176 USPQ range set forth in the claim from which it depends. 194 (CCPA 1974); and ªa moisture content of not For example, if claim 1 reads ªA circuit ¼ wherein more than 70% by weightº reads on dry material, the resistance is 70-150 ohms.º and claim 2 reads Ex parte Khusid, 174 USPQ 59 (Bd. App. 1971). ªThe circuit of claim 1 wherein the resistance is 70-100 ohms.º, then claim 2 should not be rejected III. ªEFFECTIVE AMOUNTº as inde®nite. The common phrase ªan effective amountº may or II. OPEN-ENDED NUMERICAL RANGES may not be inde®nite. The proper test is whether or not one skilled in the art could determine speci®c Open-ended numerical ranges should be carefully values for the amount based on the disclosure. See analyzed for de®niteness. For example, when an In re Mattison, 509 F.2d 563, 184 USPQ 484 independent claim recites a composition comprising (CCPA 1975). The phrase ªan effective amount . . . ªat least 20% sodiumº and a dependent claim sets for growth stimulationº was held to be de®nite where forth speci®c amounts of nonsodium ingredients the amount was not critical and those skilled in the which add up to 100%, apparently to the exclusion art would be able to determine from the written of sodium, an ambiguity is created with regard to disclosure, including the examples, what an effective the ªat leastº limitation (unless the percentages of amount is. In re Halleck, 422 F.2d 911, 164 USPQ the nonsodium ingredients are based on the weight 647 (CCPA 1970). The phrase ªan effective amountº of the nonsodium ingredients). On the other hand, has been held to be inde®nite when the claim fails the court held that a composition claimed to have a to state the function which is to be achieved and theoretical content greater than 100% (i.e., 20-80% more than one effect can be implied from the of A, 20-80% of B and 1-25% of C) was not speci®cation or the relevant art. In re Fredericksen, inde®nite simply because the claims may be read in 213 F.2d 547, 102 USPQ 35 (CCPA 1954). The theory to include compositions that are impossible more recent cases have tended to accept a limitation in fact to formulate. It was observed that subject such as ªan effective amountº as being de®nite when matter which cannot exist in fact can neither read in light of the supporting disclosure and in the anticipate nor infringe a claim. In re Kroekel, 504 absence of any prior art which would give rise to F.2d 1143, 183 USPQ 610 (CCPA 1974). uncertainty about the scope of the claim. In Ex parte Skuballa, 12 USPQ2d 1570 (Bd. Pat. App. & In a claim directed to a chemical reaction process, Inter. 1989), the Board held that a pharmaceutical a limitation required that the amount of one composition claim which recited an ªeffective ingredient in the reaction mixture should ªbe amount of a compound of claim 1º without stating maintained at less than 7 mole percentº based on the the function to be achieved was de®nite, particularly amount of another ingredient. The examiner argued when read in light of the supporting disclosure which that the claim was inde®nite because the limitation provided guidelines as to the intended utilities and sets only a maximum amount and is inclusive of how the uses could be effected. substantially no ingredient resulting in termination of any reaction. The court did not agree, holding that 2173.05(d) Exemplary Claim Language (ªfor the claim was clearly directed to a reaction process, example,º ªsuch asº) [R-07.2015] and explaining that ª[t]he imposition of a maximum limit on the quantity of one of the reactants without Description of examples or preferences is properly specifying a minimum does not warrant distorting set forth in the speci®cation rather than the claims. the overall meaning of the claim to preclude If stated in the claims, examples and preferences performing the claimed process.º In re Kirsch, 498 may lead to confusion over the intended scope of a F.2d 1389, 1394, 182 USPQ 286, ___ (CCPA 1974). claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection Some terms have been determined to have the under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, following meanings in the factual situations of the second paragraph should be made. The examiner

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should analyze whether the metes and bounds of the claim inde®nite. If the scope of a claim would be claim are clearly set forth. Note that the mere use of reasonably ascertainable by those skilled in the art, the phrase "such as" or "for example" in a claim does then the claim is not inde®nite. Ex parte Porter, 25 not by itself render the claim inde®nite. USPQ2d 1144, 1145 (Bd. Pat. App. & Inter. 1992) (ªcontrolled stream of ¯uidº provided reasonable Examples of claim language which have been held antecedent basis for ªthe controlled ¯uidº). Inherent to be inde®nite because the intended scope of the components of elements recited have antecedent claim was unclear are: basis in the recitation of the components themselves. For example, the limitation ªthe outer surface of said (A) ªR is halogen, for example, chlorineº; sphereº would not require an antecedent recitation (B) ªmaterial such as rock wool or asbestosº Ex that the sphere has an outer surface. See Bose Corp. parte Hall, 83 USPQ 38 (Bd. App. 1949); v. JBL, Inc., 274 F.3d 1354, 1359, 61 USPQ2d 1216, 1218-19 (Fed. Cir 2001) (holding that recitation of (C) ªlighter hydrocarbons, such, for example, ªan ellipseº provided antecedent basis for ªan ellipse as the vapors or gas producedº Ex parte Hasche, having a major diameterº because ª[t]here can be 86 USPQ 481 (Bd. App. 1949); no dispute that mathematically an inherent (D) ªnormal operating conditions such as while characteristic of an ellipse is a major diameterº). in the container of a proportionerº Ex parte Steigerwald, 131 USPQ 74 (Bd. App. 1961); I. EXAMINER SHOULD SUGGEST and CORRECTIONS TO ANTECEDENT PROBLEMS (E) ªcoke, brick, or like materialº. Ex parte Antecedent problems in the claims are typically Caldwell, 1906 C.D. 58 (Comm'r Pat. 1906). drafting oversights that are easily corrected once The above examples of claim language which have they are brought to the attention of applicant. The been held to be inde®nite are fact speci®c and should examiner's task of making sure the claim language not be applied as per se rules. See MPEP § 2173.02 complies with the requirements of the statute should for guidance regarding when it is appropriate to be carried out in a positive and constructive way, make a rejection under 35 U.S.C. 112(b) or pre-AIA so that minor problems can be identi®ed and easily 35 U.S.C. 112, second paragraph. corrected, and so that the major effort is expended on more substantive issues. However, even though 2173.05(e) Lack of Antecedent Basis inde®niteness in claim language is of semantic [R-07.2015] origin, it is not rendered unobjectionable simply because it could have been corrected. In re Hammack, 427 F.2d 1384, 1388 n.5, 166 USPQ 209, A claim is inde®nite when it contains words or 213 n.5 (CCPA 1970). phrases whose meaning is unclear. In re Packard, 751 F.3d 1307, 1314 (Fed. Cir. 2014). The lack of clarity could arise where a claim refers to ªsaid II. A CLAIM TERM WHICH HAS NO ANTECEDENT BASIS IN THE DISCLOSURE IS leverº or ªthe lever,º where the claim contains no NOT NECESSARILY INDEFINITE earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation The mere fact that a term or phrase used in the claim was making reference. Similarly, if two different has no antecedent basis in the speci®cation levers are recited earlier in the claim, the recitation disclosure does not mean, necessarily, that the term of ªsaid leverº in the same or subsequent claim or phrase is inde®nite. There is no requirement that would be unclear where it is uncertain which of the the words in the claim must match those used in the two levers was intended. A claim which refers to speci®cation disclosure. Applicants are given a great ªsaid aluminum lever,º but recites only ªa leverº deal of latitude in how they choose to de®ne their earlier in the claim, is inde®nite because it is invention so long as the terms and phrases used uncertain as to the lever to which reference is made. de®ne the invention with a reasonable degree of Obviously, however, the failure to provide explicit clarity and precision. antecedent basis for terms does not always render a

Rev. 07.2015, October 2015 2100-298 PATENTABILITY § 2173.05(g)

III. A CLAIM IS NOT PER SE INDEFINITE IF THE 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second BODY OF THE CLAIM RECITES ADDITIONAL paragraph. ELEMENTS WHICH DO NOT APPEAR IN THE PREAMBLE When examining a dependent claim, the examiner should also determine whether the claim complies The mere fact that the body of a claim recites with 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, additional elements which do not appear in the fourth paragraph. See MPEP § 608.01(n), subsection claim's preamble does not render the claim inde®nite II. under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Larsen, No. 01-1092 2173.05(g) Functional Limitations (Fed. Cir. May 9, 2001) (unpublished) (The preamble of the Larsen claim recited only a hanger and a loop [R-07.2015] but the body of the claim positively recited a linear member. The examiner rejected the claim under 35 A claim term is functional when it recites a feature U.S.C. 112, second paragraph, because the omission ªby what it does rather than by what it isº (e.g., as from the claim's preamble of a critical element (i.e., evidenced by its speci®c structure or speci®c a linear member) renders that claim inde®nite. The ingredients). In re Swinehart, 439 F.2d 210, 212, court reversed the examiner's rejection and stated 169 USPQ 226, 229 (CCPA 1971). There is nothing that the totality of all the limitations of the claim and inherently wrong with de®ning some part of an their interaction with each other must be considered invention in functional terms. Functional language to ascertain the inventor's contribution to the art. does not, in and of itself, render a claim improper. Upon review of the claim in its entirety, the court Id. In fact, 35 U.S.C. 112(f) and pre-AIA 35 U.S.C. concluded that the claim at issue apprises one of 112, sixth paragraph, expressly authorize a form of ordinary skill in the art of its scope and, therefore, functional claiming (means- (or step-) plus- function serves the notice function required by 35 U.S.C. 112, claim limitations discussed in MPEP § 2181 et seq.). paragraph 2.). Functional language may also be employed to limit the claims without using the means-plus-function 2173.05(f) Reference to Limitations in format. See, e.g., K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363 (Fed. Cir. 1999). Unlike Another Claim [R-11.2013] means-plus-function claim language that applies only to purely functional limitations, Phillips v. A claim which makes reference to a preceding claim AWH Corp, 415 F.3d 1303, 1311 (Fed. Cir. 2005) to de®ne a limitation is an acceptable claim (en banc) (ªMeans-plus-function claiming applies construction which should not necessarily be rejected only to purely functional limitations that do not as improper or confusing under 35 U.S.C. 112(b) or provide the structure that performs the recited pre-AIA 35 U.S.C. 112, second paragraph. For function.º), functional claiming often involves the example, claims which read: ªThe product produced recitation of some structure followed by its function. by the method of claim 1.º or ªA method of For example, in In re Schreiber, the claims were producing ethanol comprising contacting amylose directed to a conical spout (the structure) that with the culture of claim 1 under the following ªallow[ed] several kernels of popped popcorn to pass conditions .....º are not inde®nite under 35 U.S.C. through at the same timeº (the function). In re 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). As merely because of the reference to another claim. noted by the court in Schreiber, ª[a] patent applicant See also Ex parte Porter, 25 USPQ2d 1144 (Bd. is free to recite features of an apparatus either Pat. App. & Inter. 1992) (where reference to ªthe structurally or functionally.º Id. nozzle of claim 7º in a method claim was held to comply with 35 U.S.C. 112, second paragraph). A functional limitation must be evaluated and However, where the format of making reference to considered, just like any other limitation of the claim, limitations recited in another claim results in for what it fairly conveys to a person of ordinary confusion, then a rejection would be proper under skill in the pertinent art in the context in which it is used. A functional limitation is often used in

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association with an element, ingredient, or step of a 2008) (noting that the Supreme Court explained that process to de®ne a particular capability or purpose a vice of functional claiming occurs ªwhen the that is served by the recited element, ingredient or inventor is painstaking when he recites what has step. In Innova/Pure Water Inc. v. Safari Water already been seen, and then uses conveniently Filtration Sys. Inc., 381 F.3d 1111, 1117-20, 72 functional language at the exact point of noveltyº) USPQ2d 1001, 1006-08 (Fed. Cir. 2004), the court (quoting General Elec. Co. v. Wabash Appliance noted that the claim term ªoperatively connectedº Corp., 304 U.S. 364, 371 (1938)); see also United is ªa general descriptive claim term frequently used Carbon Co. v. Binney & Smith Co., 317 U.S. 228, in patent drafting to re¯ect a functional relationship 234 (1942) (holding inde®nite claims that recited between claimed components,º that is, the term substantially pure carbon black ªin the form of ªmeans the claimed components must be connected commercially uniform, comparatively small, rounded in a way to perform a designated function.º ªIn the smooth aggregates having a spongy or porous absence of modi®ers, general descriptive terms are exteriorº). Further, without reciting the particular typically construed as having their full meaning.º structure, materials or steps that accomplish the Id. at 1118, 72 USPQ2d at 1006. In the patent claim function or achieve the result, all means or methods at issue, ªsubject to any clear and unmistakable of resolving the problem may be encompassed by disavowal of claim scope, the term `operatively the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly connected' takes the full breath of its ordinary & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 meaning, i.e., `said tube [is] operatively connected (Fed. Cir. 2010) (en banc). See also Datamize LLC to said cap' when the tube and cap are arranged in v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. a manner capable of performing the function of Cir. 2005) where a claim directed to a software based ®ltering.º Id. at 1120, 72 USPQ2d at 1008. system for creating a customized computer interface screen recited that the screen be "aesthetically Other examples of permissible function language pleasing," which is an intended result and does not include the following. provide a clear cut indication of scope because it imposed no structural limits on the screen. Unlimited It was held that the limitation used to de®ne a radical on a functional claim limitations that extend to all means chemical compound as ªincapable of forming a dye with said or methods of resolving a problem may not be oxidizing developing agentº although functional, was perfectly adequately supported by the written description or acceptable because it set de®nite boundaries on the patent protection sought. In re Barr, 444 F.2d 588, 170 USPQ may not be commensurate in scope with the enabling 330(CCPA 1971). disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, ®rst paragraph. In a claim that was directed to a kit of component parts capable In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 of being assembled, the court held that limitations such as (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 ªmembers adapted to be positionedº and ªportions . . . being USPQ2d at 1167. For instance, a single means claim resiliently dilatable whereby said housing may be slidably positionedº serve to precisely de®ne present structural attributes covering every conceivable means for achieving the of interrelated component parts of the claimed assembly. In re stated result was held to be invalid under 35 U.S.C. Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976). 112, ®rst paragraph because the court recognized that the speci®cation, which disclosed only those Notwithstanding the permissible instances, the use means known to the inventor, was not commensurate of functional language in a claim may fail ªto in scope with the claim. Hyatt, 708 F.2d at 714-715, provide a clear-cut indication of the scope of the 218 USPQ at 197. For more information regarding subject matter embraced by the claimº and thus be the written description requirement and enablement inde®nite. In re Swinehart, 439 F.2d 210, 213 requirement under 35 U.S.C. 112(a) or pre-AIA 35 (CCPA 1971). For example, when claims merely U.S.C. 112, ®rst paragraph, see MPEP §§ recite a description of a problem to be solved or a 2161-2164.08(c). Examiners should keep in mind function or result achieved by the invention, the that whether or not the functional limitation complies boundaries of the claim scope may be unclear. with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, Halliburton Energy Servs., Inc. v. M-I LLC, 514 second paragraph, is a different issue from whether F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. the limitation is properly supported under 35 U.S.C.

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112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, unhelpful in distinguishing the claimed invention or is distinguished over the prior art. from the prior art. Id. at 233.

When a claim limitation employs functional In comparison, a claim limitation reciting language, the examiner's determination of whether ªtransparent to infrared raysº was held to be de®nite the limitation is suf®ciently de®nite will be highly because the speci®cation showed that a substantial dependent on context (e.g., the disclosure in the amount of infrared radiation was always transmitted speci®cation and the knowledge of a person of even though the degree of transparency varied ordinary skill in the art). Halliburton Energy Servs., depending on certain factors. Swinehart, 439 F.2d 514 F.3d at 1255, 85 USPQ2d at 1663. For example, at 214, 169 USPQ at 230. Likewise, the claims in a claim that included the term ªfragile gelº was another case were held de®nite because applicant found to be inde®nite because the de®nition of the provided ªa general guideline and examples term in the speci®cation was functional, i.e., the ¯uid suf®cient to enable a person of ordinary skill in the is de®ned by what it does rather than what it is art to determine whether a process uses a silicon (ªability of the ¯uid to transition quickly from gel dioxide source `essentially free of alkali metal' to to liquid, and the ability of the ¯uid to suspend drill make a reaction mixture `essentially free of alkali cuttings at restº), and it was ambiguous as to the metal' to produce a zeolitic compound `essentially requisite degree of the fragileness of the gel, the free of alkali metal.'º In re Marosi, 710 F.2d 799, ability of the gel to suspend drill cuttings (i.e., gel 803, 218 USPQ 289, 293 (Fed. Cir. 1983). strength), and/or some combination of the two. Halliburton Energy Servs., 514 F.3d at 1255-56, 85 Examiners should consider the following factors USPQ2d at 1663. In another example, the claims when examining claims that contain functional directed to a tungsten ®lament for electric language to determine whether the language is incandescent lamps were held invalid for including ambiguous: (1) whether there is a clear cut indication a limitation that recited ªcomparatively large grains of the scope of the subject matter covered by the of such size and contour as to prevent substantial claim; (2) whether the language sets forth sagging or offsetting during a normal or well-de®ned boundaries of the invention or only commercially useful life for such a lamp or other states a problem solved or a result obtained; and (3) device.º General Elec. Co., 304 U.S. at 370-71, whether one of ordinary skill in the art would know 375. The Court observed that the prior art ®laments from the claim terms what structure or steps are also ªconsisted of comparatively large crystalsº but encompassed by the claim. These factors are they were ªsubject to offsettingº or shifting, and the examples of points to be considered when court further found that the phrase ªof such size and determining whether language is ambiguous and are contour as to prevent substantial sagging and not intended to be all inclusive or limiting. Other offsetting during a normal or commercially useful factors may be more relevant for particular arts. The life for a lamp or other deviceº did not adequately primary inquiry is whether the language leaves room de®ne the structural characteristics of the grains for ambiguity or whether the boundaries are clear (e.g., the size and contour) to distinguish the claimed and precise. invention from the prior art. Id. at 370. Similarly, a claim was held invalid because it recited ªsustantially During prosecution, applicant may resolve the (sic) pure carbon black in the form of commercially ambiguities of a functional limitation in a number uniform, comparatively small, rounded smooth of ways. For example: (1) ªthe ambiguity might be aggregates having a spongy or porous exterior.º resolved by using a quantitative metric (e.g., numeric United Carbon Co., 317 U.S. at 234. In the latter limitation as to a physical property) rather than a example, the Court observed various problems with qualitative functional featureº (see Halliburton the limitation: ªcommercially uniformº meant only Energy Servs., 514 F.3d at 1255-56, 85 USPQ2d at the degree of uniformity buyers desired; 1663); (2) applicant could demonstrate that the ªcomparatively smallº did not add anything because ªspeci®cation provide[s] a formula for calculating no standard for comparison was given; and ªspongyº a property along with examples that meet the claim and ªporousº are synonyms that the Court found limitation and examples that do notº (see id. at 1256,

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85 USPQ2d at 1663 (citing Oakley, Inc. v. Sunglass A Markush claim may encompass a large number Hut Int'l, 316 F.3d 1331, 1341, 65 USPQ2d 1321, of alternative species, but is not necessarily inde®nite 1326 (Fed. Cir. 2003))); (3) applicant could under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, demonstrate that the speci®cation provides a general second paragraph for such breadth. In re Gardner, guideline and examples suf®cient to teach a person 427 F.2d 786, 788 (CCPA 1970) (ªBreadth is not skilled in the art when the claim limitation was inde®niteness.º). In certain circumstances, however, satis®ed (see Marosi, 710 F.2d at 803, 218 USPQ a Markush group may be so expansive that persons at 292); or (4) applicant could amend the claims to skilled in the art cannot determine the metes and recite the particular structure that accomplishes the bounds of the claimed invention. For example, a function. Markush group that encompasses a massive number of distinct alternative species may be inde®nite under 2173.05(h) Alternative Limitations 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second [R-11.2013] paragraph if one skilled in the art cannot determine the metes and bounds of the claim due to an inability I. MARKUSH GROUPS to envision all of the members of the Markush group. In such a circumstance, an examiner may reject the Alternative expressions are permitted if they present claim for inde®niteness under 35 U.S.C. 112(b) or no uncertainty or ambiguity with respect to the pre-AIA 35 U.S.C. 112, second paragraph. question of scope or clarity of the claims. A ªMarkushº claim recites a list of alternatively Similarly, the double inclusion of an element by useable species. In re Harnisch, 631 F.2d 716, members of a Markush group is not, in itself, 719-20, 206 USPQ 300, 303-04 (CCPA 1980); Ex suf®cient basis for objection to or rejection of claims. parte Markush, 1925 Dec. Comm'r Pat. 126, 127 Rather, the facts in each case must be evaluated to (1924). A Markush claim is commonly formatted determine whether or not the multiple inclusion of as: ªselected from the group consisting of A, B, and one or more elements in a claim renders that claim C;º however, the phrase ªMarkush claimº means inde®nite. The mere fact that a compound may be any claim that recites a list of alternatively useable embraced by more than one member of a Markush species regardless of format. group recited in the claim does not necessarily render the scope of the claim unclear. For example, the Ex parte Markush sanctions claiming a genus Markush group, ªselected from the group consisting expressed as a group consisting of certain speci®ed of amino, halogen, nitro, chloro and alkylº should materials. Inventions in metallurgy, refractories, be acceptable even though ªhalogenº is generic to ceramics, pharmacy, pharmacology and biology are ªchloro.º most frequently claimed under the Markush formula but purely mechanical features or process steps may The materials set forth in the Markush group also be claimed by using the Markush style of ordinarily must belong to a recognized physical or claiming. See Ex parte Head, 214 USPQ 551 (Bd. chemical class or to an art-recognized class. App. 1981); In re Gaubert, 524 F.2d 1222, 187 However, when the Markush group occurs in a claim USPQ 664 (CCPA 1975); In re Harnisch, 631 F.2d reciting a process or a combination (not a single 716, 206 USPQ 300 (CCPA 1980). It is improper to compound), it is suf®cient if the members of the use the term ªcomprisingº instead of ªconsisting group are disclosed in the speci®cation to possess of.º Ex parte Dotter, 12 USPQ 382 (Bd. App. 1931). at least one property in common which is mainly responsible for their function in the claimed The use of Markush claims of diminishing scope relationship, and it is clear from their very nature or should not, in itself, be considered a suf®cient basis from the prior art that all of them possess this for objection to or rejection of claims. However, if property. While in the past the test for Markush-type such a practice renders the claims inde®nite or if it claims was applied as liberally as possible, present results in undue multiplicity, an appropriate rejection practice which holds that claims reciting Markush should be made. groups are not generic claims (MPEP § 803) may subject the groups to a more stringent test for

Rev. 07.2015, October 2015 2100-302 PATENTABILITY § 2173.05(i)

propriety of the recited members. Where a Markush and optionally Cº was considered acceptable expression is applied only to a portion of a chemical alternative language because there was no ambiguity compound, the propriety of the grouping is as to which alternatives are covered by the claim. A determined by a consideration of the compound as similar holding was reached with regard to the term a whole, and does not depend on there being a ªoptionallyº in Ex parte Wu, 10 USPQ2d 2031 (Bd. community of properties in the members of the Pat. App. & Inter. 1989). In the instance where the Markush expression. list of potential alternatives can vary and ambiguity arises, then it is proper to make a rejection under 35 When materials recited in a claim are so related as U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second to constitute a proper Markush group, they may be paragraph, and explain why there is confusion. recited in the conventional manner, or alternatively. For example, if ªwherein R is a material selected 2173.05(i) Negative Limitations [R-11.2013] from the group consisting of A, B, C and Dº is a proper limitation, then ªwherein R is A, B, C or Dº The current view of the courts is that there is nothing shall also be considered proper. inherently ambiguous or uncertain about a negative limitation. So long as the boundaries of the patent Subgenus Claim protection sought are set forth de®nitely, albeit negatively, the claim complies with the requirements Genus, subgenus, and Markush-type claims, if of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, properly supported by the disclosure, are all second paragraph. Some older cases were critical of acceptable ways for applicants to claim their negative limitations because they tended to de®ne inventions. They provide different ways to present the invention in terms of what it was not, rather than claims of different scope. Examiners should therefore pointing out the invention. Thus, the court observed not reject Markush-type claims merely because there that the limitation ªR is an alkenyl radical other than are genus claims that encompass the Markush-type 2-butenyl and 2,4-pentadienylº was a negative claims. limitation that rendered the claim inde®nite because it was an attempt to claim the invention by excluding See also MPEP § 608.01(p) and § 715.03. what the inventors did not invent rather than distinctly and particularly pointing out what they did See MPEP § 803.02 for restriction practice re invent. In re Schechter, 205 F.2d 185, 98 USPQ Markush-type claims. 144 (CCPA 1953).

II. ªORº TERMINOLOGY A claim which recited the limitation ªsaid homopolymer being free from the proteins, soaps, Alternative expressions using ªorº are acceptable, resins, and sugars present in natural Hevea rubberº such as ªwherein R is A, B, C, or D.º The following in order to exclude the characteristics of the prior phrases were each held to be acceptable and not in art product, was considered de®nite because each violation of 35 U.S.C. 112, second paragraph in In recited limitation was de®nite. In re Wake®eld, 422 re Gaubert, 524 F.2d 1222, 187 USPQ 664 (CCPA F.2d 897, 899, 904, 164 USPQ 636, 638, 641 (CCPA 1975): ªmade entirely or in part ofº; ªat least one 1970). In addition, the court found that the negative pieceº; and ªiron, steel or any other magnetic limitation ªincapable of forming a dye with said material.º oxidized developing agentº was de®nite because the boundaries of the patent protection sought were III. ªOPTIONALLYº clear. In re Barr, 444 F.2d 588, 170 USPQ 330 (CCPA 1971). An alternative format which requires some analysis before concluding whether or not the language is Any negative limitation or exclusionary proviso must inde®nite involves the use of the term ªoptionally.º have basis in the original disclosure. If alternative In Ex parte Cordova, 10 USPQ2d 1949 (Bd. Pat. elements are positively recited in the speci®cation, App. & Inter. 1989) the language ªcontaining A, B, they may be explicitly excluded in the claims. See

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In re Johnson, 558 F.2d 1008, 1019, 194 USPQ The court pointed out in In re Bernhart, 417 F.2d 187, 196 (CCPA 1977) (ª[the] speci®cation, having 1395, 163 USPQ 611 (CCPA 1969) that the statutory described the whole, necessarily described the part language (particularly point out and distinctly claim) remaining.º). See also Ex parte Grasselli, 231 is the only proper basis for an old combination USPQ 393 (Bd. App. 1983), aff'd mem., 738 F.2d rejection, and in applying the rejection, that language 453 (Fed. Cir. 1984). The mere absence of a positive determines what an applicant has a right and recitation is not basis for an exclusion. Any claim obligation to do. A majority opinion of the Board of containing a negative limitation which does not have Appeals held that Congress removed the underlying basis in the original disclosure should be rejected rationale of Lincoln Engineering in the 1952 Patent under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, Act, and thereby effectively legislated that decision ®rst paragraph, as failing to comply with the written out of existence. Ex parte Barber, 187 USPQ 244 description requirement. Note that a lack of literal (Bd. App. 1974). Finally, the Court of Appeals for basis in the speci®cation for a negative limitation the Federal Circuit, in Radio Steel and Mfg. Co. v. may not be suf®cient to establish a prima facie case MTD Products, Inc., 731 F.2d 840, 221 USPQ 657 for lack of descriptive support. Ex parte Parks, 30 (Fed. Cir. 1984), followed the Bernhart case, and USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). ruled that a claim was not invalid under Lincoln See MPEP § 2163 - § 2163.07(b) for a discussion Engineering because the claim complied with the of the written description requirement of 35 U.S.C. requirements of 35 U.S.C. 112, second paragraph. 112(a) and pre-AIA 35 U.S.C. 112, ®rst paragraph. Accordingly, a claim should not be rejected on the ground of old combination. 2173.05(j) Old Combination [R-11.2013] 2173.05(k) Aggregation [R-08.2012] A CLAIM SHOULD NOT BE REJECTED ON THE GROUND OF OLD COMBINATION A claim should not be rejected on the ground of ªaggregation.º In re Gustafson, 331 F.2d 905, 141 With the passage of the 1952 Patent Act, the courts USPQ 585 (CCPA 1964) (an applicant is entitled to and the Board have taken the view that a rejection know whether the claims are being rejected under based on the principle of old combination is NO 35 U.S.C. 101, 102, 103, or 112); In re Collier, LONGER VALID. Claims should be considered 397 F.2d 1003, 1006, 158 USPQ 266, 268 (CCPA proper so long as they comply with the provisions 1968) (ª[A] rejection for `aggregation' is of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, non-statutory.º). second paragraph. If a claim omits essential matter or fails to interrelate A rejection on the basis of old combination was essential elements of the invention as de®ned by based on the principle applied in Lincoln applicant(s) in the speci®cation, see MPEP Engineering Co. v. Stewart-Warner Corp., 303 U.S. § 2172.01. 545, 37 USPQ 1 (1938). The principle was that an inventor who made an improvement or contribution to but one element of a generally old combination, 2173.05(l) [Reserved] should not be able to obtain a patent on the entire combination including the new and improved element. A rejection required the citation of a single reference which broadly disclosed a combination of 2173.05(m) Prolix [R-08.2012] the claimed elements functionally cooperating in substantially the same manner to produce Examiners should reject claims as prolix only substantially the same results as that of the claimed when they contain such long recitations or combination. The case of In re Hall, 208 F.2d 370, unimportant details that the scope of the claimed 100 USPQ 46 (CCPA 1953) illustrates an application invention is rendered inde®nite thereby. Claims are of this principle. rejected as prolix when they contain long recitations

Rev. 07.2015, October 2015 2100-304 PATENTABILITY § 2173.05(o)

that the metes and bounds of the claimed subject based on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. matter cannot be determined. 112, second paragraph, should be made in the next Of®ce action along with an action on the merits on 2173.05(n) Multiplicity [R-11.2013] the selected claims. If applicant refuses to comply with the telephone request, an undue multiplicity 37 CFR 1.75 Claim(s). rejection of all the claims based on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, should (a) The speci®cation must conclude with a claim particularly pointing out and distinctly claiming the subject be made in the next Of®ce action. Applicant's reply matter which the applicant regards as his invention or discovery. must include a selection of claims for purpose of (b) More than one claim may be presented provided they examination, the number of which may not be greater differ substantially from each other and are not unduly than the number speci®ed by the examiner. In multiplied. response to applicant's reply, if the examiner adheres ***** to the undue multiplicity rejection, it should be repeated and the selected claims will be examined Where, in view of the nature and scope of applicant's on the merits. This procedure preserves applicant's invention, applicant presents an unreasonable right to have the rejection on undue multiplicity number of claims which are repetitious and reviewed by the Patent Trail and Appeal Board. multiplied, the net result of which is to confuse rather than to clarify, a rejection on undue multiplicity based on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. Also, it is possible to reject one claim over an 112, second paragraph, may be appropriate. As noted allowed claim if they differ only by subject matter by the court in In re Chandler, 319 F.2d 211, 225, old in the art. This ground of rejection is set forth in 138 USPQ 138, 148 (CCPA 1963), ªapplicants Ex parte Whitelaw, 1915 C.D. 18, 219 O.G. 1237 should be allowed reasonable latitude in stating their (Comm'r Pat. 1914). The Ex parte Whitelaw claims in regard to number and phraseology doctrine is restricted to cases where the claims are employed. The right of applicants to freedom of unduly multiplied or are substantial duplicates. Ex choice in selecting phraseology which truly points parte Kochan, 131 USPQ 204, 206 (Bd. App. 1961). out and de®nes their inventions should not be abridged. Such latitude, however, should not be 2173.05(o) Double Inclusion [R-08.2012] extended to sanction that degree of repetition and multiplicity which beclouds de®nition in a maze of There is no per se rule that ªdouble inclusionº is confusion. The rule of reason should be practiced improper in a claim. In re Kelly, 305 F.2d 909, 916, and applied on the basis of the relevant facts and 134 USPQ 397, 402 (CCPA 1962) (ªAutomatic circumstances in each individual case.º See also In reliance upon a `rule against double inclusion' will re Flint, 411 F.2d 1353, 1357, 162 USPQ 228, 231 lead to as many unreasonable interpretations as will (CCPA 1969). Undue multiplicity rejections based automatic reliance upon a `rule allowing double on 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, inclusion'. The governing consideration is not second paragraph, should be applied judiciously and double inclusion, but rather is what is a reasonable should be rare. construction of the language of the claims.º). Older cases, such as Ex parte White, 759 O.G. 783 (Bd. If an undue multiplicity rejection under 35 U.S.C. App. 1958) and Ex parte Clark, 174 USPQ 40 (Bd. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, App. 1971) should be applied with care, according is appropriate, the examiner should contact applicant to the facts of each case. by telephone explaining that the claims are unduly multiplied and will be rejected under 35 U.S.C. The facts in each case must be evaluated to 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. determine whether or not the multiple inclusion of Note MPEP § 408. The examiner should also request one or more elements in a claim gives rise to that applicant select a speci®ed number of claims inde®niteness in that claim. The mere fact that a for purpose of examination. If applicant is willing compound may be embraced by more than one to select, by telephone, the claims for examination, member of a Markush group recited in the claim an undue multiplicity rejection on all the claims does not lead to any uncertainty as to the scope of

2100-305 Rev. 07.2015, October 2015 § 2173.05(p) MANUAL OF PATENT EXAMINING PROCEDURE

that claim for either examination or infringement rather to actions of the individual callers, which purposes. On the other hand, where a claim directed creates confusion as to when direct infringement to a device can be read to include the same element occurs. Katz, 639 F.3d at 1318 (citing IPXL twice, the claim may be inde®nite. Ex parte Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, Kristensen, 10 USPQ2d 1701 (Bd. Pat. App. & Inter. 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which 1989). a system claim that recited ªan input meansº and required a user to use the input means was found to 2173.05(p) Claim Directed to Product-By- be inde®nite because it was unclear ªwhether Process or Product and Process [R-11.2013] infringement ¼ occurs when one creates a system that allows the user [to use the input means], or There are many situations where claims are whether infringement occurs when the user actually permissively drafted to include a reference to more uses the input means.º); Ex parte Lyell, 17 USPQ2d than one statutory class of invention. 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the I. PRODUCT-BY-PROCESS method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph). A product-by-process claim, which is a product claim that de®nes the claimed product in terms of 2173.05(q) ªUseº Claims [R-11.2013] the process by which it is made, is proper. In re Luck, 476 F.2d 650, 177 USPQ 523 (CCPA 1973); Attempts to claim a process without setting forth In re Pilkington, 411 F.2d 1345, 162 USPQ 145 any steps involved in the process generally raises an (CCPA 1969); In re Steppan, 394 F.2d 1013, 156 issue of inde®niteness under 35 U.S.C. 112(b) or USPQ 143 (CCPA 1967). A claim to a device, pre-AIA 35 U.S.C. 112, second paragraph. For apparatus, manufacture, or composition of matter example, a claim which read: ª[a] process for using may contain a reference to the process in which it is monoclonal antibodies of claim 4 to isolate and intended to be used without being objectionable purify human ®broblast interferonº was held to be under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, inde®nite because it merely recites a use without second paragraph, so long as it is clear that the claim any active, positive steps delimiting how this use is is directed to the product and not the process. actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). An applicant may present claims of varying scope even if it is necessary to describe the claimed product Other decisions suggest that a more appropriate basis in product-by-process terms. Ex parte Pantzer, 176 for this type of rejection is 35 U.S.C. 101. In Ex USPQ 141 (Bd. App. 1972). parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper II. PRODUCT AND PROCESS IN THE SAME de®nition of a process: ªThe use of a high carbon CLAIM austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by A single claim which claims both an apparatus and sliding friction.º In Clinical Products Ltd. v. the method steps of using the apparatus is inde®nite Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 1966), the district court held the following claim second paragraph. See In re Katz Interactive Call was de®nite, but that it was not a proper process Processing Patent Litigation, 639 F.3d 1303, 97 claim under 35 U.S.C. 101: ªThe use of a sustained USPQ2d 1737 (Fed. Cir. 2011). In Katz, a claim release therapeutic agent in the body of ephedrine directed to ª[a] system with an interface means for absorbed upon polystyrene sulfonic acid.º providing automated voice messages¼to certain of said individual callers, wherein said certain of said Although a claim should be interpreted in light of individual callers digitally enter dataº was the speci®cation disclosure, it is generally considered determined to be inde®nite because the italicized improper to read limitations contained in the claim limitation is not directed to the system, but speci®cation into the claims. See In re Prater, 415

Rev. 07.2015, October 2015 2100-306 PATENTABILITY § 2173.05(t)

F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re For cancellation of such a claim by examiner's Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA amendment, see MPEP § 1302.04(b). 1975), which discuss the premise that one cannot rely on the speci®cation to impart limitations to the 2173.05(s) Reference to Figures or Tables claim that are not recited in the claim. [R-08.2012]

I. A ªUSEº CLAIM SHOULD BE REJECTED Where possible, claims are to be complete in UNDER ALTERNATIVE GROUNDS BASED ON 35 themselves. Incorporation by reference to a speci®c U.S.C 101 AND 112 ®gure or table ªis permitted only in exceptional circumstances where there is no practical way to In view of the split of authority as discussed above, de®ne the invention in words and where it is more the most appropriate course of action would be to concise to incorporate by reference than duplicating reject a ªuseº claim under alternative grounds based a drawing or table into the claim. Incorporation by on 35 U.S.C. 101 and 112 . reference is a necessity doctrine, not for applicant's convenience.º Ex parte Fressola, 27 USPQ2d 1608, II. BOARD HELD STEP OF ªUTILIZINGº WAS 1609 (Bd. Pat. App. & Inter. 1993) (citations NOT INDEFINITE omitted). It is often dif®cult to draw a ®ne line between Reference characters corresponding to elements what is permissible, and what is objectionable from recited in the detailed description and the drawings the perspective of whether a claim is de®nite. In the may be used in conjunction with the recitation of case of Ex parte Porter, 25 USPQ2d 1144 (Bd. Pat. the same element or group of elements in the claims. App. & Inter. 1992), the Board held that a claim See MPEP § 608.01(m). which clearly recited the step of ªutilizingº was not inde®nite under 35 U.S.C. 112, second paragraph. (Claim was to ªA method for unloading nonpacked, 2173.05(t) Chemical Formula [R-11.2013] nonbridging and packed, bridging ¯owable particle catalyst and bead material from the opened end of Claims to chemical compounds and compositions a reactor tube which comprises utilizing the nozzle containing chemical compounds often use formulas of claim 7.º). that depict the chemical structure of the compound. These structures should not be considered inde®nite 2173.05(r) Omnibus Claim [R-11.2013] nor speculative in the absence of evidence that the assigned formula is in error. The absence of corroborating spectroscopic or other data cannot be Some applications are ®led with an omnibus claim the basis for ®nding the structure inde®nite. See Ex which reads as follows: A device substantially as parte Morton, 134 USPQ 407 (Bd. App. 1961), and shown and described. This claim should be rejected Ex parte Sobin, 139 USPQ 528 (Bd. App. 1962). under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it is inde®nite in that it fails to point out what is included or excluded by the A claim to a chemical compound is not inde®nite claim language. See Ex parte Fressola, 27 USPQ2d merely because a structure is not presented or 1608 (Bd. Pat. App. & Inter. 1993), for a discussion because a partial structure is presented. For example, of the history of omnibus claims and an explanation the claim language at issue in In re Fisher, 427 F.2d of why omnibus claims do not comply with the 833, 166 USPQ 18 (CCPA 1970) referred to a requirements of 35 U.S.C. 112(b) or pre-AIA 35 chemical compound as a ªpolypeptide of at least 24 U.S.C. 112, second paragraph. amino acids having the following sequence.º A rejection under pre-AIA 35 U.S.C. 112, second paragraph, for failure to identify the entire structure Such a claim can be rejected using form paragraph was reversed and the court held: ªWhile the absence 7.35. See MPEP § 706.03(d). of such a limitation obviously broadens the claim and raises questions of suf®ciency of disclosure, it

2100-307 Rev. 07.2015, October 2015 § 2173.05(u) MANUAL OF PATENT EXAMINING PROCEDURE

does not render the claim inde®nite.º Chemical should be rejected under 35 U.S.C. 112(b) or compounds may be claimed by a name that pre-AIA 35 U.S.C. 112, second paragraph. adequately describes the material to one skilled in the art. See Martin v. Johnson, 454 F.2d 746, 172 2173.05(v) Mere Function of Machine USPQ 391 (CCPA 1972). A compound of unknown [R-11.2013] structure may be claimed by a combination of physical and chemical characteristics. See Ex Process or method claims are not subject to rejection parte Brian, 118 USPQ 242 (Bd. App. 1958). A by U.S. Patent and Trademark Of®ce examiners compound may also be claimed in terms of the under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, process by which it is made without raising an issue second paragraph, solely on the ground that they of inde®niteness. de®ne the inherent function of a disclosed machine or apparatus. In re Tarczy-Hornoch, 397 F.2d 856, 2173.05(u) Trademarks or Trade Names in 158 USPQ 141 (CCPA 1968). The court in a Claim [R-11.2013] Tarczy-Hornoch held that a process claim, otherwise patentable, should not be rejected merely because The presence of a trademark or trade name in a claim the application of which it is a part discloses an is not, per se, improper under 35 U.S.C. 112(b) or apparatus which will inherently carry out the recited pre-AIA 35 U.S.C. 112, second paragraph, but the steps. claim should be carefully analyzed to determine how the mark or name is used in the claim. It is important 2173.06 Practice Compact Prosecution to recognize that a trademark or trade name is used [R-07.2015] to identify a source of goods, and not the goods themselves. Thus a trademark or trade name does I. INTERPRET THE CLAIM AND APPLY ART not identify or describe the goods associated with WITH AN EXPLANATION OF HOW AN the trademark or trade name. See de®nitions of INDEFINITE TERM IS INTERPRETED trademark and trade name in MPEP § 608.01(v). The goal of examination is to clearly articulate any If the trademark or trade name is used in a claim as rejection early in the prosecution process so that the a limitation to identify or describe a particular applicant has the chance to provide evidence of material or product, the claim does not comply with patentability and otherwise reply completely at the the requirements of the 35 U.S.C. 112(b) or pre-AIA earliest opportunity. See MPEP § 706. Under the 35 U.S.C. 112, second paragraph. Ex parte Simpson, principles of compact prosecution, the examiner 218 USPQ 1020 (Bd. App. 1982). The claim scope should review each claim for compliance with every is uncertain since the trademark or trade name cannot statutory requirement for patentability in the initial be used properly to identify any particular material review of the application and identify all of the or product. In fact, the value of a trademark would applicable grounds of rejection in the ®rst Of®ce be lost to the extent that it became descriptive of a action to avoid unnecessary delays in the prosecution product, rather than used as an identi®cation of a of the application. See 37 CFR 1.104(a)(1) (ªOn source or origin of a product. Thus, the use of a taking up an application for examination or a patent trademark or trade name in a claim to identify or in a reexamination proceeding, the examiner shall describe a material or product would not only render make a thorough study thereof and shall make a a claim inde®nite, but would also constitute an thorough investigation of the available prior art improper use of the trademark or trade name. relating to the subject matter of the claimed invention. The examination shall be complete with If a trademark or trade name appears in a claim and respect both to compliance of the application . . . is not intended as a limitation in the claim, the with the applicable statutes and rules and to the question of why it is in the claim should be patentability of the invention as claimed, as well as addressed. If its presence in the claim causes with respect to matters of form, unless otherwise confusion as to the scope of the claim, then the claim indicated.º).

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Thus, when the examiner determines that a claim proper interpretation of the limitations of a claim, it term or phrase renders the claim inde®nite, the would not be proper to reject such a claim on the examiner should make a rejection based on basis of prior art. As stated in In re Steele, 305 F.2d inde®niteness under 35 U.S.C. 112(b) or pre-AIA 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 112, second paragraph, as well as a 35 U.S.C. 103 should not be based on considerable rejection(s) in view of the prior art under 35 U.S.C. speculation about the meaning of terms employed 102 or 103 that renders the prior art applicable based in a claim or assumptions that must be made as to on the examiner's interpretation of the claim. See the scope of the claims. In re Packard, 751 F.3d 1307, 1312 (Fed. Cir. 2014) (stating that the prima facie case is appropriately The ®rst approach is recommended from an used for making an inde®niteness rejection). When examination standpoint because it avoids piecemeal making a rejection over prior art in these examination in the event that the examiner's 35 circumstances, it is important that the examiner U.S.C. 112, second paragraph rejection is not state on the record how the claim term or phrase af®rmed, and may give applicant a better is being interpreted with respect to the prior art appreciation for relevant prior art if the claims are applied in the rejection. By rejecting each claim on redrafted to avoid the 35 U.S.C. 112(b) or pre-AIA all reasonable grounds available, the examiner can 35 U.S.C. 112, second paragraph rejection. avoid piecemeal examination. See MPEP § 707.07(g) (ªPiecemeal examination should be avoided as much 2174 Relationship Between the Requirements as possible. The examiner ordinarily should reject of 35 U.S.C. 112(a) and (b) or Pre-AIA 35 each claim on all valid grounds available . . . .º). U.S.C. 112, First and Second Paragraphs [R-11.2013] II. PRIOR ART REJECTION OF CLAIM REJECTED AS INDEFINITE The requirements of 35 U.S.C. 112(a) and (b) or the All words in a claim must be considered in judging ®rst and second paragraphs of pre-AIA 35 U.S.C. the patentability of a claim against the prior art. In 112 are separate and distinct. If a description or the re Wilson, 424 F.2d 1382, 165 USPQ 494 (CCPA enabling disclosure of a speci®cation is not 1970). The fact that terms may be inde®nite does commensurate in scope with the subject matter not make the claim obvious over the prior art. When encompassed by a claim, that fact alone does not the terms of a claim are considered to be inde®nite, render the claim imprecise or inde®nite or otherwise at least two approaches to the examination of an not in compliance with 35 U.S.C. 112(b) or pre-AIA inde®nite claim relative to the prior art are possible. 35 U.S.C. 112, second paragraph; rather, the claim is based on an insuf®cient disclosure (35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph) First, where the degree of uncertainty is not and should be rejected on that ground. In great, and where the claim is subject to more than re Borkowski, 422 F.2d 904, 164 USPQ 642 (CCPA one interpretation and at least one interpretation 1970). If the speci®cation discloses that a particular would render the claim unpatentable over the prior feature or element is critical or essential to the art, an appropriate course of action would be for the practice of the invention, failure to recite or include examiner to enter two rejections: (A) a rejection that particular feature or element in the claims may based on inde®niteness under 35 U.S.C. 112(b) or provide a basis for a rejection based on the ground pre-AIA 35 U.S.C. 112, second paragraph; and (B) that those claims are not supported by an enabling a rejection over the prior art based on the disclosure. In re Mayhew, 527 F.2d 1229, 188 USPQ interpretation of the claims which renders the prior 356 (CCPA 1976). In Mayhew, the examiner argued art applicable. See, e.g., Ex parte Ionescu, that the only mode of operation of the process 222 USPQ 537 (Bd. App. 1984). When making a disclosed in the speci®cation involved the use of a rejection over prior art in these circumstances, it is cooling zone at a particular location in the processing important for the examiner to point out how the cycle. The claims were rejected because they failed claim is being interpreted. Second, where there is a to specify either a cooling step or the location of the great deal of confusion and uncertainty as to the step in the process. The court was convinced that

2100-309 Rev. 07.2015, October 2015 § 2175 MANUAL OF PATENT EXAMINING PROCEDURE -2180 the cooling bath and its location were essential, and The Court of Appeals for the Federal Circuit, in its held that claims which failed to recite the use of a en banc decision In re Donaldson Co., 16 F.3d cooling zone, speci®cally located, were not 1189, 1194, 29 USPQ2d 1845, 1850 (Fed. Cir. supported by an enabling disclosure (35 U.S.C. 112, 1994), held that a ªmeans-or-step-plus-functionº ®rst paragraph). limitation should be interpreted as follows:

In addition, if a claim is amended to include an Per our holding, the ªbroadest reasonable invention that is not described in the application as interpretationº that an examiner may give ®led, a rejection of that claim under 35 U.S.C. 112(a) means-plus-function language is that statutorily or pre-AIA 35 U.S.C. 112, ®rst paragraph, as being mandated in paragraph six. Accordingly, the directed to subject matter that is not described in the PTO may not disregard the structure disclosed speci®cation as ®led may be appropriate. In in the speci®cation corresponding to such re Simon, 302 F.2d 737, 133 USPQ 524 (CCPA language when rendering a patentability 1962). In Simon, which involved a reissue determination. application containing claims to a reaction product of a composition, applicant presented claims to a Therefore, the broadest reasonable interpretation of reaction product of a composition comprising the a claim limitation that invokes 35 U.S.C. 112(f) or subcombination A+B+C, whereas the original claims pre-AIA 35 U.S.C. 112, sixth paragraph, is the and description of the invention were directed to a structure, material or act described in the composition comprising the combination speci®cation as performing the entire claimed A+B+C+D+E. The court found no signi®cant function and equivalents to the disclosed structure, support for the argument that ingredients D+E were material or act. As a result, section 112(f) or pre-AIA not essential to the claimed reaction product and section 112, sixth paragraph, limitations will, in concluded that claims directed to the reaction product some cases, be afforded a more narrow interpretation of a subcombination A+B+C were not described (35 than a limitation that is not crafted in ªmeans plus U.S.C. 112, ®rst paragraph) in the application as functionº format. ®led. See also In re Panagrossi, 277 F.2d 181, 125 USPQ 410 (CCPA 1960). I. DETERMINING WHETHER A CLAIM LIMITATION INVOKES 35 U.S.C. 112(f) or 2175 PRE-AIA 35 U.S.C. 112, SIXTH PARAGRAPH -2180 [Reserved] The USPTO must apply 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph in appropriate cases, 2181 Identifying and Interpreting a 35 U.S.C. and give claims their broadest reasonable 112(f) or Pre-AIA 35 U.S.C. 112, Sixth interpretation, in light of and consistent with the Paragraph Limitation [R-07.2015] written description of the invention in the application. See Donaldson, 16 F.3d at 1194, 29 This section sets forth guidelines for the examination USPQ2d at 1850 (stating that 35 U.S.C. 112, sixth of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph ªmerely sets a limit on how broadly the paragraph, ªmeans or step plus functionº limitations PTO may construe means-plus-function language in a claim. These guidelines are based on the Of®ce's under the rubric of reasonable interpretation'º). The current understanding of the law and are believed to Federal Circuit has held that applicants (and be fully consistent with binding precedent of the reexamination patentees) before the USPTO have Supreme Court, the Federal Circuit and the Federal the opportunity and the obligation to de®ne their Circuit's predecessor courts. These guidelines do inventions precisely during proceedings before the not constitute substantive rulemaking and hence do USPTO. See In re Morris, 127 F.3d 1048, 1056±57, not have the force and effect of law. 44 USPQ2d 1023, 1029±30 (Fed. Cir. 1997) (35 U.S.C. 112, second paragraph places the burden of precise claim drafting on the applicant); In re Zletz, 893 F.2d 319, 322, 13 USPQ2d 1320, 1322 (Fed.

Rev. 07.2015, October 2015 2100-310 PATENTABILITY § 2181

Cir. 1989) (manner of claim interpretation that is 115 USPQ2d 1105, 2015 WL 3687459, at *6-7 (Fed. used by courts in litigation is not the manner of claim Cir. 2015) ( en banc) (quoting Watts v. XL Systems, interpretation that is applicable during prosecution Inc., 232 F.3d 877, 880 (Fed. Cir. 2001); see also of a pending application before the USPTO); Sage Personalized Media Communications, LLC v. Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, International Trade Commission, 161 F. 3d 696, 704 1425, 44 USPQ2d 1103, 1107 (Fed. Cir. 1997) (Fed. Cir. 1998). Instead of using "means" or "step" (patentee who had a clear opportunity to negotiate in such cases, a substitute term acts as a generic broader claims during prosecution but did not do so, placeholder for the term "means" and would not be may not seek to expand the claims through the recognized by one of ordinary skill in the art as being doctrine of equivalents, for it is the patentee, not the suf®ciently de®nite structure for performing the public, who must bear the cost of failure to seek claimed function. "The standard is whether the words protection for this foreseeable alteration of its of the claim are understood by persons of ordinary claimed structure). skill in the art to have a suf®ciently de®nite meaning as the name for structure." Williamson, 2015 WL If a claim limitation recites a term and associated 3687459, at *7; see also Greenberg v. Ethicon functional language, the examiner should determine Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir. whether the claim limitation invokes 35 U.S.C. 1996). 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The claim limitation is presumed to invoke 35 U.S.C. Accordingly, examiners will apply 35 U.S.C. 112(f) 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph or pre-AIA 35 U.S.C. 112, sixth paragraph to a claim when it explicitly uses the term ªmeansº or ªstepº limitation if it meets the following 3-prong analysis: and includes functional language. That presumption is overcome when the limitation further includes the (A) the claim limitation uses the term ªmeansº structure necessary to perform the recited function. or ªstepº or a term used as a substitute for ªmeansº TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, that is a generic placeholder (also called a nonce 1259-60, 85 USPQ2d 1787, 1789 (Fed. Cir. 2008) term or a non-structural term having no speci®c (ªSuf®cient structure exists when the claim language structural meaning) for performing the claimed speci®es the exact structure that performs the function; function in question without need to resort to other (B) the term ªmeansº or ªstepº or the generic portions of the speci®cation or extrinsic evidence placeholder is modi®ed by functional language, for an adequate understanding of the structure.º); typically, but not always linked by the transition see also Altiris, Inc. v. Symantec Corp., 318 F.3d word ªforº (e.g., ªmeans forº) or another linking 1363, 1376, 65 USPQ2d 1865, 1874 (Fed. Cir. word or phrase, such as "con®gured to" or "so that"; 2003). and

By contrast, a claim limitation that does not use the (C) the term ªmeansº or ªstepº or the generic term ªmeansº or ªstepº will trigger the rebuttable placeholder is not modi®ed by suf®cient structure, presumption that 35 U.S.C. 112(f) or pre-AIA 35 material, or acts for performing the claimed function. U.S.C. 112, sixth paragraph does not apply. See, A. The Claim Limitation Uses the Term ªMeansº or e.g., Phillips v. AWH Corp., 415 F.3d 1303, 1310, ªStepº or a Generic Placeholder (A Term That Is Simply 75 USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc); A Substitute for ªMeansº) CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1369, 62 USPQ2d 1658, 1664 (Fed. Cir. With respect to the ®rst prong of this analysis, a 2002); Personalized Media Commc'ns, LLC v. ITC, claim element that does not include the term ªmeansº 161 F.3d 696, 703-04, 48 USPQ2d 1880, 1886±87 or ªstepº triggers a rebuttable presumption that 35 (Fed. Cir. 1998). The presumption is overcome when U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth "the claim term fails to ©recite suf®ciently de®nite paragraph, does not apply. When the claim limitation structure© or else recites ©function without reciting does not use the term ªmeans,º examiners should suf®cient structure for performing that function.©" determine whether the presumption that 35 U.S.C. Williamson v. Citrix Online, LLC, ___F.3d ____, 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6 does

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not apply is overcome. The presumption may be paragraph). The following are examples of structural overcome if the claim limitation uses a generic terms that have been found not to invoke 35 U.S.C. placeholder (a term that is simply a substitute for 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: the term ªmeansº). The following is a list of ªcircuit,º ªdetent mechanism,º ªdigital detector,º non-structural generic placeholders that may invoke ªreciprocating member,º ªconnector assembly,º 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, ªperforation,º ªsealingly connected joints,º and paragraph 6: ªmechanism for,º ªmodule for,º ªeyeglass hanger member.º See Mass. Inst. of Tech., ªdevice for,º ªunit for,º ªcomponent for,º 462 F.3d at 1355-1356, 80 USPQ2d at 1332 (the ªelement for,º ªmember for,º ªapparatus for,º court found the recitation of "aesthetic correction ªmachine for,º or ªsystem for.º Welker Bearing circuitry" suf®cient to avoid pre-AIA 35 U.S.C. 112, Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d paragraph 6, treatment because the term circuit, 1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst. combined with a description of the function of the of Tech. v. Abacus Software, 462 F.3d 1344, 1354, circuit, connoted suf®cient structure to one of 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); ordinary skill in the art.); Linear Tech. Corp. v. Personalized Media, 161 F.3d at 704, 48 USPQ2d Impala Linear Corp., 379 F.3d 1311, 1321, 72 at 1886±87; Mas-Hamilton Group v. LaGard, Inc., USPQ2d 1065, 1071 (Fed. Cir. 2004); Apex, 325 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 F.3d at 1373, 66 USPQ2d at 1452; Greenberg, 91 (Fed. Cir. 1998). This list is not exhaustive, and other F.3d at 1583-84, 39 USPQ2d at 1786; Personalized generic placeholders may invoke 35 U.S.C. 112(f) Media, 161 F.3d at 704-05, 39 USPQ2d at 1786; or pre-AIA 35 U.S.C. 112, paragraph 6. CCS Fitness, 288 F.3d at 1369-70, 62 USPQ2d at 1664-65; Cole v. Kimberly-Clark Corp., 102 F.3d However, 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 524, 531 (Fed. Cir. 1996); Watts, 232 F.3d at 881, 112, paragraph 6 will not apply if persons of ordinary 56 USPQ2d at 1839; Al-Site Corp. v. VSI Int'l, Inc., skill in the art reading the speci®cation understand 174 F.3d 1308, 1318-19, 50 USPQ2d 1161, 1166-67 the term to have a suf®ciently de®nite meaning as (Fed. Cir. 1999). the name for the structure that performs the function, even when the term covers a broad class of structures For a term to be considered a substitute for ªmeans,º or identi®es the structures by their function (e.g., and lack suf®cient structure for performing the ª®lters,º ªbrakes,º ªclamp,º ªscrewdriver,º and function, it must serve as a generic placeholder and ªlocksº). Apex Inc. v. Raritan Computer, Inc., 325 thus not limit the scope of the claim to any speci®c F.3d 1364, 1372-73, 66 USPQ2d 1444, 1451-52 manner or structure for performing the claimed (Fed. Cir. 2003); CCS Fitness, 288 F.3d at 1369, function. It is important to remember that there are 62 USPQ2d at 1664; Watts v. XL Sys. Inc., 232 F.3d no absolutes in the determination of terms used as 877, 880-81, 56 USPQ2d 1836, 1839 (Fed. Cir. a substitute for ªmeansº that serve as generic 2000); Personalized Media, 161 F.3d at 704, 48 placeholders. The examiner must carefully consider USPQ2d at 1888; Greenberg v. Ethicon the term in light of the speci®cation and the Endo-Surgery, Inc., 91 F.3d 1580, 1583, 39 USPQ2d commonly accepted meaning in the technological 1783, 1786 (Fed. Cir. 1996) (ªMany devices take art. Every application will turn on its own facts. their names from the functions they perform.º) The term is not required to denote a speci®c structure or If the examiner has not interpreted a claim limitation a precise physical structure to avoid the application as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, 112, sixth paragraph and an applicant wishes to have paragraph 6. See Watts, 232 F.3d at 880, 56 the claim limitation treated under 35 U.S.C. 112(f) USPQ2d at 1838; Inventio AG v. Thyssenkrupp or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant Elevator Americas Corp., 649 F.3d 1350, 99 must either: (A) amend the claim to include the USPQ2d 1112 (Fed. Cir. 2011) (holding that the phrase ªmeansº or ªstepº; or (B) rebut the claim terms "modernizing device" and "computing presumption that 35 U.S.C. 112(f) or pre-AIA 35 unit" when read in light of the speci®cation connoted U.S.C. 112, sixth paragraph does not apply by suf®cient, de®nite structure to one of skill in the art showing that the claim limitation is written as a to preclude application of 35 U.S.C. 112, sixth function to be performed and does not recite

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suf®cient structure, material, or acts to perform that holding the lever¼and for releasing the leverº were function. See Watts, 232 F.3d at 881, 56 USPQ2d construed as means-plus-function limitations at 1839 (Fed. Cir. 2000) (Claim limitations were invoking 35 U.S.C. 112, sixth paragraph since the held not to invoke 35 U.S.C. 112, sixth paragraph, claimed limitations were described in terms of their because the absence of the term ªmeansº raised the function rather than their mechanical structure); presumption that the limitations were not in Ethicon, Inc. v. United States Surgical Corp., 135 means-plus-function form and the applicant did not F.3d 1456, 1463, 45 USPQ2d 1545, 1550 (Fed. Cir. rebut that presumption.); see also Masco Corp. v. 1998) (ªuse of the word `means' gives rise to a United States, 303 F.3d 1316, 1327, 64 USPQ2d presumption that the inventor used the term 1182, 1189 (Fed. Cir. 2002) (ª[W]here a method advisedly to invoke the statutory mandates for claim does not contain the term `step[s] for,' a means-plus-function clausesº) (quotation omitted). limitation of that claim cannot be construed as a However, compare Al-Site Corp. v. VSI Int'l, Inc., step-plus-function limitation without a showing that 174 F.3d 1308, 1317-19, 50 USPQ2d 1161, 1166-67 the limitation contains no act.º). (Fed. Cir. 1999) (holding that although the claim elements ªeyeglass hanger memberº and ªeyeglass Some of the following examples illustrate situations contacting memberº include a function, these claim where the term ªmeansº or ªstepº was not used but elements do not invoke 35 U.S.C. 112, sixth either the Board or courts nevertheless determined paragraph because the claims themselves contain that the claim limitation fell within the scope of 35 suf®cient structural limitations for performing these U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth functions); O.I. Corp. v. Tekmar, 115 F.3d 1576, paragraph. Note that the examples are fact speci®c 1583, 42 USPQ2d 1777, 1782 (Fed. Cir. 1997) and should not be applied as per se rules. See (method claim that paralleled means-plus-function Signtech USA, Ltd. v. Vutek, Inc., 174 F.3d 1352, apparatus claim but lacked ªstep forº language did 1356, 50 USPQ2d 1372, 1374±75 (Fed. Cir.1999) not invoke 35 U.S.C. 112, sixth paragraph). (ªink delivery means positioned on ¼º invokes 35 U.S.C. 112, sixth paragraph since the phrase ªink When applicant uses the term ªmeansº or ªstepº in delivery meansº is equivalent to ªmeans for ink the preamble, a rejection under 35 U.S.C. 112(b) or deliveryº); Seal-Flex, Inc. v. Athletic Track and pre-AIA 35 U.S.C. 112, second paragraph may be Court Construction, 172 F.3d 836, 850, 50 USPQ2d appropriate when it is unclear whether the preamble 1225, 1234 (Fed. Cir. 1999) (Rader, J., concurring) is reciting a means- (or step-) plus- function (ªClaim elements without express step-plus-function limitation or whether the preamble is merely stating language may nevertheless fall within Section 112, the intended use of the claimed invention. If Para. 6 if they merely claim the underlying function applicant uses a structural or generic placeholder without recitation of acts for performing that with the word ªforº or other linking word in the function¼. In general terms, the `underlying preamble, the examiner should not construe such function' of a method claim element corresponds to phrase as reciting a means-plus-function limitation. what that element ultimately accomplishes in relationship to what the other elements of the claim The Examiner is reminded that, absent a and the claim as a whole accomplish. `Acts,' on the determination that a claim limitation invokes 35 other hand, correspond to how the function is U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth accomplished¼. If the claim element uses the phrase paragraph, the broadest reasonable interpretation `step for,' then Section 112, Para. 6 is presumed to will not be limited to ªcorresponding structure¼ apply¼. On the other hand, the term `step' alone and equivalents thereof.º Morris, 127 F.3d at 1055, and the phrase `steps of' tend to show that Section 44 USPQ2d at 1028 (ªno comparable mandate in 112, Para. 6 does not govern that limitation.º); the patent statute that relates the claim scope of Personalized Media, 161 F.3d at 703±04, 48 non-§ 112 paragraph 6 claims to particular matter USPQ2d at 1886±87 (Fed. Cir. 1998); found in the speci®cationº). Mas-Hamilton, 156 F.3d at 1213, 48 USPQ2d at 1016 (Fed. Cir. 1998) (ªlever moving element for moving the leverº and ªmovable link member for

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B. The Term ªMeansº or ªStepº or the Generic functions). Also, a statement of function appearing Placeholder Must Be Modi®ed By Functional Language only in the claim preamble is generally insuf®cient to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. With respect to the second prong of this analysis, it 112, sixth paragraph. O.I. Corp., 115 F.3d at 1583, must be clear that the element in the claims is set 42 USPQ2d at 1782 (ª[A] statement in a preamble forth, at least in part, by the function it performs as of a result that necessarily follows from performing opposed to the speci®c structure, material, or acts a series of steps does not convert each of those steps that perform the function. See York Prod., Inc. v. into step- plus-function clauses. The steps of Central Tractor Farm & Family Center, 99 F.3d `passing' are not individually associated in the claims 1568, 1574, 40 USPQ2d 1619, 1624 (Fed. Cir. 1996) with functions performed by the steps of passing.º). (holding that a claim limitation containing the term ªmeansº does not invoke 35 U.S.C. 112, sixth The mere use of the term ªmeansº with no associated paragraph, if the claim limitation does not link the function rebuts the presumption that 35 U.S.C. 112(f) term ªmeansº to a speci®c function). Caterpillar or pre-AIA 35 U.S.C. 112, sixth paragraph, is Inc. v. Detroit Diesel Corp., 41 USPQ2d 1876, 1882 invoked. A function must be recited within the claim (N.D. Ind. 1996) (stating that 35 U.S.C. 112, sixth limitation, but it is not necessary that a particular paragraph, ªapplies to functional method claims format be used. Typically, the claim limitation will where the element at issue sets forth a step for use the linking word ªforº to associate ªmeansº or reaching a particular result, but not the speci®c a generic placeholder with the function. However, technique or procedure used to achieve the result.º); other linking words may be used, such as ªso thatº O.I. Corp., 115 F.3d at 1582-83, 42 USPQ2d at 1782 or ªcon®gured toº, provided it is clear that the claim (With respect to process claims, ª[35 U.S.C. 112, element is reciting a function. In certain sixth paragraph] is implicated only when steps plus circumstances, it is also not necessary to use a function without acts are present¼. If we were to linking word if other words used with ªmeansº, or construe every process claim containing steps the generic placeholder, convey the function. Such described by an `ing' verb, such as passing, heating, words, however, cannot convey speci®c structure reacting, transferring, etc., into a step-plus-function, for performing the function or the phrase will not be we would be limiting process claims in a manner treated as invoking 35 U.S.C. 112(f) or pre-AIA 35 never intended by Congress.º (emphasis in original)); U.S.C. 112, sixth paragraph. For example, ªink see also Baran v. Medical Device Techs., Inc., 616 delivery meansº, ªmodule con®gured to deliver inkº F.3d 1309, 1317, 96 USPQ2d 1057, 1063 (Fed. Cir. and ªmeans for ink deliveryº could all be interpreted 2010) (the claimed function may include the as claim elements that invoke 35 U.S.C. 112(f) or functional language that precedes the phrase ªmeans pre-AIA 35 U.S.C. 112, sixth paragraph. See for.º). However, ªthe fact that a particular Signtech USA, 174 F.3d at 1356. mechanism¼is de®ned in functional terms is not suf®cient to convert a claim element containing that C. The Term ªMeansº or ªStepº or the Generic term into a `means for performing a speci®ed Placeholder Must Not Be Modi®ed By Suf®cient function' within the meaning of section 112(6).º Structure, Material, or Acts for Achieving the Speci®ed Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d Function 1580, 1583, 39 USPQ2d 1783, 1786 (Fed. Cir. 1996) (ªdetent mechanismº de®ned in functional terms With respect to the third prong of this analysis, the was not intended to invoke 35 U.S.C. 112, sixth term ªmeansº or ªstepº or the generic placeholder paragraph); see also Al-Site Corp. v. VSI recited in the claim must not be modi®ed by International Inc., 174 F.3d 1308, 1318, 50 USPQ2d suf®ciently de®nite structure, material, or acts for 1161, 1166±67 (Fed. Cir. 1999) (although the claim achieving the speci®ed function. See Seal-Flex, 172 elements ªeyeglass hanger memberº and ªeyeglass F.3d at 849, 50 USPQ2d at 1234 (Radar, J., contacting memberº include a function, these claim concurring) (ªEven when a claim element uses elements do not invoke 35 U.S.C. 112, sixth language that generally falls under the paragraph, because the claims themselves contain step-plus-function format, however, [35 U.S.C.] 112 suf®cient structural limitations for performing those ¶ 6 still does not apply when the claim limitation

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itself recites suf®cient acts for performing the USPQ2d at 1786 (holding that the term ªdetent speci®ed function.º); Envirco Corp. v. Clestra mechanismº did not to invoke 35 U.S.C. 112, sixth Cleanroom, Inc., 209 F.3d 1360, 54 USPQ2d 1449 paragraph because the structural modi®er ªdetentº (Fed. Cir. 2000) (holding ªsecond baf¯e meansº denotes a type of structural device with a generally does not invoke 35 U.S.C. 112, sixth paragraph, understood meaning in the mechanical arts). By because the word ªbaf¯eº itself imparts structure contrast, a generic placeholder (e.g., ªmechanism,º and the claim further recites the structure of the ªelement,º ªmemberº) coupled with a function may baf¯e); Rodime PLC v. Seagate Technology, Inc., invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, 174 F.3d 1294, 1303±04, 50 USPQ2d 1429, 1435±36 sixth paragraph when it is preceded by a (Fed. Cir. 1999) (holding ªpositioning means for non-structural modi®er that does not have any movingº does not invoke 35 U.S.C. 112, sixth generally understood structural meaning in the art paragraph, because the claim further provides a list (e.g., ªcolorant selection mechanism,º ªlever moving of the structure underlying the means and the element,º or ªmovable link memberº). See detailed recitation of the structure for performing Massachusetts Inst. of Tech., 462 F.3d at 1354, 80 the moving function removes this element from the USPQ2d at 1231 (The claim recited use of a colorant purview of 35 U.S.C. 112, sixth paragraph); Cole selection mechanism, to which the court performed v. Kimberly-Clark Corp., 102 F.3d 524, 531, 41 a means-plus-function analysis under pre-AIA 35 USPQ2d 1001, 1006 (Fed. Cir. 1996) (holding U.S.C. 112, sixth paragraph. The court held that the ªperforation means¼for tearingº does not invoke term "colorant selection", which modi®es the generic 35 U.S.C. 112, sixth paragraph, because the claim term "mechanism", was not de®ned in the describes the structure supporting the tearing speci®cation, had no dictionary de®nition, nor any function (i.e., perforation)). In other situations, the generally understood meaning in the art, the term Federal Circuit has come to a different conclusion. does not connote suf®cient structure to a person of See Unidynamics Corp. v. Automatic Prod. Int'l, ordinary skill in the art to avoid pre-AIA 35 U.S.C. 157 F.3d 1311, 1319, 48 USPQ2d 1099, 1104 (Fed. 112, sixth paragraph treatment.); Mas-Hamilton, Cir. 1998) (holding that ªspring meansº invokes 156 F.3d at 1214-1215, 48 USPQ2d at 1017. 35 U.S.C. 112, sixth paragraph). To determine whether a word, term, or phrase Examiners will apply 35 U.S.C. 112(f) or pre-AIA coupled with a function denotes structure, examiners 35 U.S.C. 112, sixth paragraph to a claim limitation should check whether: (1) the speci®cation provides that uses the term ªmeansº or ªstepº or generic a description suf®cient to inform one of ordinary placeholder associated with functional language, skill in the art that the term denotes structure; (2) unless that term is (1) preceded by a structural general and subject matter speci®c dictionaries modi®er, de®ned in the speci®cation as a particular provide evidence that the term has achieved structure or known by one skilled in the art, that recognition as a noun denoting structure; and (3) the denotes the type of structural device (e.g., ª®ltersº), prior art provides evidence that the term has an or (2) modi®ed by suf®cient structure or material art-recognized structure to perform the claimed for achieving the claimed function. function. Ex parte Rodriguez, 92 USPQ2d 1395, 1404 (Bd. Pat. App. & Int. 2009) (precedential). A limitation will not invoke 35 U.S.C. 112(f) or ªThe standard is whether the words of the claim are pre-AIA 35 U.S.C. 112, sixth paragraph if there is understood by persons of ordinary skill in the art to a structural modi®er that further describes the term have a suf®ciently de®nite meaning as the name for ªmeansº or ªstepº or the generic placeholder. For structure.º Williamson v. Citrix Online, LLC, example, although a generic placeholder like ___F.3d ____, 115 USPQ2d 1105, 2015 WL 367459, ªmechanismº standing alone may invoke 35 U.S.C. at *7 (Fed. Cir. June 16, 2015). 112(f) 35 U.S.C. 112, sixth paragraph when coupled with a function, it will not invoke 35 U.S.C. 112(f) During examination, however, applicants have the or pre-AIA 35 U.S.C. 112, sixth paragraph when it opportunity and the obligation to de®ne their is preceded by a structural modi®er (e.g., ªdetent inventions precisely, including whether a claim mechanismº). Greenberg, 91 F.3d at 1583, 39 limitation invokes 35 U.S.C. 112(f) or pre-AIA 35

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U.S.C. 112, sixth paragraph. Thus, if the term If a claim limitation uses the term ªmeansº or ªstep,º ªmeansº or ªstepº or a generic placeholder is but the examiner determines that either the second modi®ed by suf®cient structure, material or acts for prong or the third prong of the 3-prong analysis is achieving the speci®ed function, the USPTO will not met, then in these situations, the examiner must consider that presumption has been rebutted and will include a statement in the Of®ce action explaining not apply 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. the reasons why a claim limitation which uses the 112, sixth paragraph, until such modifying language term ªmeansº or ªstepº is not being treated under is deleted from the claim limitation. 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. It is necessary to decide on an element by element basis whether 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. In the event that it is unclear whether the claim 112, sixth paragraph, applies. Not all terms in a limitation falls within the scope of 35 U.S.C. 112(f) means-plus-function or step-plus-function clause are or pre-AIA 35 U.S.C. 112, sixth paragraph, a limited to what is disclosed in the written description rejection under 35 U.S.C. 112(b) or pre-AIA 35 and equivalents thereof, since 35 U.S.C. 112(f) or U.S.C. 112, second paragraph, may be appropriate. pre-AIA 35 U.S.C. 112, sixth paragraph, applies only to the interpretation of the means or step that II. DESCRIPTION NECESSARY TO SUPPORT A performs the recited function. See, e.g., IMS CLAIM LIMITATION WHICH INVOKES 35 U.S.C. Technology Inc. v. Haas Automation Inc., 206 F.3d 112(f) or Pre-AIA 35 U.S.C. 112, SIXTH 1422, 54 USPQ2d 1129 (Fed. Cir. 2000) (the term PARAGRAPH ªdata blockº in the phrase ªmeans to sequentially display data block inquiriesº was not the means that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth caused the sequential display, and its meaning was paragraph states that a claim limitation expressed in not limited to the disclosed embodiment and means- (or step-) plus-function language ªshall be equivalents thereof). Each claim must be construed to cover the corresponding independently reviewed to determine the structure¼described in the speci®cation and applicability of 35 U.S.C. 112(f) or pre-AIA 35 equivalents thereof.º ªIf one employs means plus U.S.C. 112, sixth paragraph, even where the function language in a claim, one must set forth in application contains substantially similar process the speci®cation an adequate disclosure showing and apparatus claims. O.I. Corp., 115 F.3d at what is meant by that language. If an applicant fails 1583-1584, 42 USPQ2d at 1782 (ªWe understand to set forth an adequate disclosure, the applicant has that the steps in the method claims are essentially in in effect failed to particularly point out and distinctly the same language as the limitations in the apparatus claim the invention as required by the 35 U.S.C. claim, albeit without the `means for' quali®cation¼. 112(b) [or the second paragraph of pre-AIA section Each claim must be independently reviewed in order 112].º In re Donaldson Co., 16 F.3d 1189, 1195, to determine if it is subject to the requirements of 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). section 112, ¶ 6. Interpretation of claims would be confusing indeed if claims that are not means- or A. The Corresponding Structure Must Be Disclosed step- plus function were to be interpreted as if they In the Speci®cation Itself in a Way That One Skilled In were, only because they use language similar to that the Art Will Understand What Structure Will Perform used in other claims that are subject to this the Recited Function provision.º). The proper test for meeting the de®niteness requirement is that the corresponding structure (or Where a claim limitation meets the 3-prong analysis material or acts) of a means- (or step-) plus-function and is being treated under 35 U.S.C. 112(f) or limitation must be disclosed in the speci®cation itself pre-AIA 35 U.S.C. 112, sixth paragraph, the in a way that one skilled in the art will understand examiner will include a statement in the Of®ce what structure (or material or acts) will perform the action that the claim limitation is being treated under recited function. See Atmel Corp. v. Information 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth Storage Devices, Inc., 198 F.3d 1374, 1381, 53 paragraph. See MPEP § 2181, subsection VI., below. USPQ2d 1225, 1230 (Fed. Cir. 1999). In Atmel, the

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patentee claimed an apparatus that included a ªhigh the claimed dual functions. Because no structure voltage generating meansº limitation, thereby disclosed in the embodiments of the invention invoking 35 U.S.C. 112, sixth paragraph. The actually performs the claimed dual functions, the speci®cation incorporated by reference a non-patent speci®cation lacks corresponding structure as document from a technical journal, which described required by 35 U.S.C. 112, sixth paragraph, and fails a particular high voltage generating circuit. The to comply with 35 U.S.C. 112, second paragraph.). Federal Circuit concluded that the title of the article in the speci®cation may, by itself, be suf®cient to Whether a claim reciting an element in means- (or indicate to one skilled in the art the precise structure step-) plus-function language fails to comply with of the means for performing the recited function, 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second and it remanded the case to the district court ªto paragraph, because the speci®cation does not consider the knowledge of one skilled in the art that disclose adequate structure (or material or acts) for indicated, based on unrefuted testimony, that the performing the recited function is closely related to speci®cation disclosed suf®cient structure the question of whether the speci®cation meets the corresponding to the high-voltage means limitation.º description requirement in 35 U.S.C. 112(a) or Id. at 1382, 53 USPQ2d at 1231. pre-AIA 35 U.S.C. 112, ®rst paragraph. See In re Noll, 545 F.2d 141, 149, 191 USPQ 721, 727 (CCPA The disclosure of the structure (or material or acts) 1976) (unless the means-plus-function language is may be implicit or inherent in the speci®cation if it itself unclear, a claim limitation written in would have been clear to those skilled in the art what means-plus- function language meets the de®niteness structure (or material or acts) corresponds to the requirement in 35 U.S.C. 112, second paragraph, so means- (or step-) plus-function claim limitation. See long as the speci®cation meets the written id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 description requirement in 35 U.S.C. 112, ®rst F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. paragraph). In Aristocrat Techs. Australia Pty Ltd. 1997). If there is no disclosure of structure, material v. Int'l Game Tech., 521 F.3d 1328, 1336-37, 86 or acts for performing the recited function, the claim USPQ2d 1235, 1242 (Fed. Cir. 2008), the court fails to satisfy the requirements of 35 U.S.C. 112(b) stated: or pre-AIA 35 U.S.C. 112, second paragraph. ª[A] bare statement that known techniques or methods Enablement of a device requires only the can be used does not disclose structureº in the disclosure of suf®cient information so that a context of a means plus function limitation. person of ordinary skill in the art could make Biomedino, LLC v. Waters Technology Corp., 490 and use the device. A section 112[(f) or F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. pre-AIA] paragraph 6 disclosure, however, 2007) (Disclosure that an invention ªmay be serves the very different purpose of limiting controlled by known differential pressure, valving the scope of the claim to the particular structure and control equipmentº was not a disclosure of any disclosed, together with equivalents. ¼ For structure corresponding to the claimed ªcontrol example, in Atmel Corp. v. Information means for operating [a] valving º and the claim was Storage Devices, Inc., 198 F.3d 1374, 1380[, held inde®nite). See also Budde v. Harley-Davidson, 53 USPQ2d 1225, 1230] (Fed. Cir. 1999), the Inc., 250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806 court embraced the proposition that (Fed. Cir. 2001); Cardiac Pacemakers, Inc. v. St. `consideration of the understanding of one Jude Med., Inc., 296 F.3d 1106, 1115-18, 63 skilled in the art in no way relieves the patentee USPQ2d 1725, 1731-34 (Fed. Cir. 2002) (Court of adequately disclosing suf®cient structure in interpreted the language of the ªthird monitoring the speci®cation.' It is not enough for the means for monitoring the ECG signal¼for activating patentee simply to state or later argue that ¼º to require the same means to perform both persons of ordinary skill in the art would know functions and the only entity referenced in the what structures to use to accomplish the speci®cation that could possibly perform both claimed function. The court in Biomedino, LLC functions is the physician. The court held that v. Waters Technologies Corp., 490 F.3d 946, excluding the physician, no structure accomplishes 953[, 83 USPQ2d 1118, 1123] (Fed. Cir. 2007),

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put the point this way: "The inquiry is whether does not simply state `computer' or some equivalent one of skill in the art would understand the phrase).º). speci®cation itself to disclose a structure, not simply whether that person would be capable B. Computer-Implemented Means-Plus-Function of implementing that structure." Limitations

As noted above, when rendering patentability The invocation of 35 U.S.C. 112(f) or pre-AIA determinations the Of®ce may not disregard the 35 U.S.C. 112, sixth paragraph, does not exempt an structure disclosed in the speci®cation corresponding applicant from compliance with 35 U.S.C. 112(a) to the means-plus-function language. ª[W]hen the and 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, disclosed structure is a computer programmed to ®rst and second paragraphs. See Donaldson, 16 carry out an algorithm, `the disclosed structure is F.3d at 1195, 29 USPQ2d at 1850; In re Knowlton, not the general purpose computer, but rather that 481 F.2d 1357, 1366, 178 USPQ 486, 493 (CCPA special purpose computer programmed to perform 1973) (ª[The sixth paragraph of section 112] cannot the disclosed algorithm.'º In re Aoyama, 656 F.3d be read as creating an exception either to the 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) description requirement of the ®rst paragraph ¼ or (quoting WMS Gaming, Inc. v. Int'l Game Tech., to the de®niteness requirement found in the second 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. paragraph of section 112. Means-plus-function Cir. 1999)); see also In re Alappat, 33 F.3d 1526, language can be used in the claims, but the claims 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994) (en must still accurately de®ne the invention.º). banc). In cases involving a special purpose computer-implemented means-plus-function Under certain limited circumstances, the written limitation, the Federal Circuit has consistently description does not have to explicitly describe the required that the structure be more than simply a structure (or material or acts) corresponding to a general purpose computer or microprocessor and means- (or step-) plus-function limitation to that the speci®cation must disclose an algorithm for particularly point out and distinctly claim the performing the claimed function. See, e.g., Noah invention as required by 35 U.S.C. 112(b) or Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 pre-AIA 35 U.S.C. 112, second paragraph. See USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, Dossel, 115 F.3d at 946, 42 USPQ2d at 1885. Under 521 F.3d at 1333, 86 USPQ2d at 1239. proper circumstances, drawings may provide a written description of an invention as required by For a computer-implemented means-plus-function 35 U.S.C. 112. Vas-Cath, Inc. v. Mahurkar, 935 claim limitation invoking 35 U.S.C. 112(f) or F.2d 1555, 1565, 19 USPQ2d 1111, 1118 (Fed. Cir. pre-AIA 35 U.S.C. 112, sixth paragraph, a general 1991). Further, disclosure of structure corresponding purpose computer is usually only suf®cient as the to a means-plus-function limitation may be implicit corresponding structure for performing a general in the written description if it would have been clear computing function (e.g., ªmeans for storing dataº), to those skilled in the art what structure must perform but the corresponding structure for performing a the function recited in the means-plus-function speci®c function is required to be more than simply limitation. See Atmel Corp. v. Information Storage a general purpose computer or microprocessor. In Devices Inc., 198 F.3d 1374, 1379, 53 USPQ2d In re Katz Interactive Call Processing Patent 1225, 1228 (Fed. Cir. 1999) (stating that the ªone Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, skilled in the artº analysis should apply in 1747 (Fed. Cir. 2011) (citations omitted), the court determining whether suf®cient structure has been stated: disclosed to support a means-plus-function limitation); Dossel, 115 F.3d at 946±47, 42 USPQ2d at 1885 (ªClearly, a unit which receives digital data, Those cases involved speci®c functions that performs complex mathematical computations and would need to be implemented by programming outputs the results to a display must be implemented a general purpose computer to convert it into by or on a general or special purpose computer a special purpose computer capable of (although it is not clear why the written description performing those speci®ed functions. By

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contrast, in the seven claims identi®ed above, computer programmed to perform the disclosed Katz has not claimed a speci®c function algorithm.'º (quoting WMS Gaming, 184 F.3d at performed by a special purpose computer, but 1349, 51 USPQ2d at 1391.)) An algorithm is de®ned, has simply recited the claimed functions of for example, as ªa ®nite sequence of steps for `processing,' `receiving,' and `storing.' Absent solving a logical or mathematical problem or a possible narrower construction of the terms performing a task.º Microsoft Computer Dictionary, `processing,' `receiving,' and `storing,' Microsoft Press, 5th edition, 2002. Applicant may discussed below, those functions can be express the algorithm in any understandable terms achieved by any general purpose computer including as a mathematical formula, in prose, in a without special programming. As such, it was ¯ow chart, or ªin any other manner that provides not necessary to disclose more structure than suf®cient structure.º Finisar, 523 F.3d at 1340, 86 the general purpose processor that performs USPQ2d at 1623; see also Intel Corp. v. VIA Techs., those functions. Those seven claims do not run Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 afoul of the rule against purely functional (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, claiming, because the functions of `processing,' 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); `receiving,' and `storing' are coextensive with Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, the structure disclosed, i.e., a general purpose 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In processor. re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.

The Federal Circuit case law regarding special To claim a means for performing a speci®c purpose computer-implemented means-plus-function computer-implemented function and then to disclose claims is divided into two distinct groups. The ®rst only a general purpose computer as the structure group includes cases in which the speci®cation designed to perform that function amounts to pure discloses no algorithm, and the second group functional claiming. Aristocrat, 521 F.3d 1328 at includes cases in which the speci®cation does 1333, 86 USPQ2d at 1239. In this instance, the disclose an algorithm, but an issue exists as to structure corresponding to a 35 U.S.C. 112(f) or whether the disclosure is adequate to perform the pre-AIA 35 U.S.C. 112, sixth paragraph claim entire claimed function(s). The suf®ciency of the limitation for a computer-implemented function must algorithm is determined in view of what one of include the algorithm needed to transform the general ordinary skill in the art would understand as purpose computer or microprocessor disclosed in suf®cient to de®ne the structure and make the the speci®cation. Aristocrat, 521 F.3d at 1333, 86 boundaries of the claim understandable. See Noah, USPQ2d at 1239; Finisar Corp. v. DirecTV Group, 675 F.3d at 1313, 102 USPQ2d at 1417. Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 Accordingly, a rejection under 35 U.S.C. 112(b) or (Fed. Cir. 1999). The corresponding structure is not pre-AIA 35 U.S.C. 112, second paragraph is simply a general purpose computer by itself but the appropriate if the speci®cation discloses no special purpose computer as programmed to perform corresponding algorithm associated with a computer the disclosed algorithm. Aristocrat, 521 F.3d at or microprocessor. Aristocrat, 521 F.3d at 1337-38, 1333, 86 USPQ2d at 1239. Thus, the speci®cation 86 USPQ2d at 1242. For example, mere reference must suf®ciently disclose an algorithm to transform to a general purpose computer with appropriate a general purpose microprocessor to the special programming without providing an explanation of purpose computer. See Aristocrat, 521 F.3d at 1338, the appropriate programming, or simply reciting 86 USPQ2d at 1241. (ªAristocrat was not required ªsoftwareº without providing detail about the means to produce a listing of source code or a highly to accomplish a speci®c software function, would detailed description of the algorithm to be used to not be an adequate disclosure of the corresponding achieve the claimed functions in order to satisfy 35 structure to satisfy the requirements of 35 U.S.C. U.S.C. § 112 ¶ 6. It was required, however, to at 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. least disclose the algorithm that transforms the Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239; general purpose microprocessor to a `special purpose Finisar, 523 F.3d at 1340-41, 86 USPQ2d at 1623.

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In addition, merely referencing a specialized function cannot ®ll in the gaps in the speci®cation computer (e.g., a ªbank computerº), some unde®ned for structure needed to perform a different function. component of a computer system (e.g., ªaccess Where a disclosed algorithm supports some, but not control managerº), ªlogic,º ªcode,º or elements that all, of the functions associated with a are essentially a black box designed to perform the means-plus-function limitation, the speci®cation is recited function, will not be suf®cient because there treated as if no algorithm has been disclosed at all. must be some explanation of how the computer or Moreover, attempting to ®ll in the gaps of the the computer component performs the claimed speci®cation by importing off the shelf software or function. Blackboard, Inc. v. Desire2Learn, Inc., asserting that individuals of ordinary skill in the art 574 F.3d 1371, 1383-85, 91 USPQ2d 1481, 1491-93 would understand how to accomplish the function (Fed. Cir. 2009); Net MoneyIN, Inc. v. VeriSign, described with the assistance of such off the shelf Inc., 545 F.3d 1359, 1366-67, 88 USPQ2d 1751, software does not solve the inadequacy of the 1756-57 (Fed. Cir. 2008); Rodriguez, 92 USPQ2d disclosure. Noah, 675 F.3d at 1318, 102 USPQ2d at 1405-06. at 1421.

If the speci®cation explicitly discloses an algorithm, In several Federal Circuit cases, the patentees argued the suf®ciency of the disclosure of the algorithm that the requirement for the disclosure of an must be determined in light of the level of ordinary algorithm can be avoided if one of ordinary skill in skill in the art. Aristocrat, 521 F.3d at 1337, 86 the art is capable of writing the software to convert USPQ2d at 1241; AllVoice Computing PLC v. a general purpose computer to a special purpose Nuance Commc'ns, Inc., 504 F.3d 1236, 1245, 84 computer to perform the claimed function. See, e.g., USPQ2d 1886, 1893 (Fed. Cir. 2007); Intel Corp., Blackboard, 574 F.3d at 1385, 91 USPQ2d at 1493; 319 F.3d at 1366-67, 65 USPQ2d 1934, 1941 Biomedino, 490 F.3d at 952, 83 USPQ2d at 1123; (knowledge of a person of ordinary skill in the art Atmel Corp., 198 F.3d at 1380, 53 USPQ2d at 1229. can be used to make clear how to implement a Such argument was found to be unpersuasive disclosed algorithm). The examiner should determine because the understanding of one skilled in the art whether one skilled in the art would know how to does not relieve the patentee of the duty to disclose program the computer to perform the necessary steps suf®cient structure to support means-plus-function described in the speci®cation (i.e., the invention is claim terms. Blackboard, 574 F.3d at 1385, 91 enabled), and that the inventor was in possession of USPQ2d at 1493 (ªA patentee cannot avoid the invention (i.e., the invention meets the written providing speci®city as to structure simply because description requirement). Thus, the speci®cation someone of ordinary skill in the art would be able must suf®ciently disclose an algorithm to transform to devise a means to perform the claimed function.º); a general purpose microprocessor to a special Atmel Corp., 198 F.3d at 1380, 53 USPQ2d at 1229 purpose computer so that a person of ordinary skill (ª[C]onsideration of the understanding of one skilled in the art can implement the disclosed algorithm to in the art in no way relieves the patentee of achieve the claimed function. Aristocrat, 521 F.3d adequately disclosing suf®cient structure in the at 1338, 86 USPQ2d at 1242. speci®cation.º). The speci®cation must explicitly disclose the algorithm for performing the claimed A rejection under 35 U.S.C. 112(b) or pre-AIA 35 function, and simply reciting the claimed function U.S.C. 112, second paragraph is also appropriate if in the speci®cation will not be a suf®cient disclosure the speci®cation discloses an algorithm but the for an algorithm which, by de®nition, must contain algorithm is not suf®cient to perform the entire a sequence of steps. Blackboard, 574 F.3d at 1384, claimed function. For example, for a function that 91 USPQ2d at 1492 (stating that language that includes two distinct functional components, simply describes the function to be performed disclosure of an algorithm that is suf®cient to describes an outcome, not a means for achieving that perform one of the functions but not the other would outcome); Microsoft Computer Dictionary, Microsoft not be adequate to satisfy the requirements of 35 Press, 5th edition, 2002; see also Encyclopaedia U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second Britannica, Inc. v. Alpine Elecs., Inc., 355 Fed. paragraph. The disclosure of structure to support one Appx. 389, 394-95, 2009 U.S. App. Lexis. 26358,

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10-16 (Fed. Cir. 2009) (holding that implicit or C. The Supporting Disclosure Clearly Links or inherent disclosure of a class of algorithms for Associates the Disclosed Structure, Material, or Acts to performing the claimed functions is not suf®cient, the Claimed Function and the purported ªone-stepº algorithm is not an algorithm at all) (unpublished). The structure disclosed in the written description of the speci®cation is the corresponding structure only Often the supporting disclosure for a if the written description of the speci®cation or the computer-implemented invention discusses the prosecution history clearly links or associates that implementation of the functionality of the invention structure to the function recited in a means- (or step-) through hardware, software, or a combination of plus-function claim limitation under 35 U.S.C. 112(f) both. In this situation, a question can arise as to or pre-AIA 35 U.S.C. 112, sixth paragraph. See B. which mode of implementation supports the Braun Medical Inc., v. Abbott Laboratories, 124 means-plus-function limitation. The language of 35 F.3d 1419, 1424, 43 USPQ2d 1896, 1900 (Fed. Cir. U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth 1997). The requirement that a particular structure paragraph requires that the recited ªmeansº for be clearly linked with the claimed function in order performing the speci®ed function shall be construed to qualify as corresponding structure is the quid pro to cover the corresponding ªstructure or materialº quo for the convenience of employing 35 U.S.C. described in the speci®cation and equivalents 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, thereof. Therefore, by choosing to use a and is also supported by the requirement of 35 means-plus-function limitation and invoke 35 U.S.C. U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, paragraph, that an invention must be particularly applicant limits that claim limitation to the disclosed pointed out and distinctly claimed. See Medical structure, i.e., implementation by hardware or the Instrumentation & Diagnostics Corp. v. Elekta AB, combination of hardware and software, and 344 F.3d 1205, 1211, 68 USPQ2d 1263, 1268. For equivalents thereof. Therefore, the examiner should a means- (or step-) plus- function claim limitation not construe the limitation as covering pure software that invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. implementation. 112, sixth paragraph, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, However, if there is no corresponding structure is appropriate if one of ordinary skill in the art cannot disclosed in the speci®cation (i.e., the limitation is identify what structure, material, or acts disclosed only supported by software and does not correspond in the written description of the speci®cation perform to an algorithm and the computer or microprocessor the claimed function. programmed with the algorithm), the limitation should be deemed inde®nite as discussed above, and III. DETERMINING 35 U.S.C. 112(b) or Pre-AIA 35 the claim should be rejected under 35 U.S.C. 112(f) U.S.C. 112 SECOND PARAGRAPH COMPLIANCE WHEN 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112 or pre-AIA 35 U.S.C. 112, second paragraph. It is SIXTH PARAGRAPH IS INVOKED important to remember that claims must be interpreted as a whole; so, a claim that includes a Once the examiner determines that a claim limitation means-plus-function limitation that corresponds to is a means-plus-function limitation invoking 35 software per se (and is thus inde®nite for lacking U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth structural support in the speci®cation) is not paragraph, the examiner should determine the necessarily directed as a whole to software per se claimed function and then review the written unless the claim lacks other structural limitations. description of the speci®cation to determine whether the corresponding structure, material, or acts that As noted below in subsection III., if it is unclear perform the claimed function are disclosed. Note whether there is suf®cient supporting structure or that drawings may provide a written description of whether the algorithm is adequate to perform the an invention as required by 35 U.S.C. 112. See entire claimed function, it is appropriate to reject the Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1565, claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). The 112, second paragraph. corresponding structure, material, or acts may be

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disclosed in the original drawings, ®gures, tables, (1) when it is unclear whether a claim limitation or sequence listing. However, the corresponding invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, structure, material, or acts cannot include any sixth paragraph; structure, material, or acts disclosed only in the (2) when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. material incorporated by reference or a prior art 112, sixth paragraph is invoked and there is no reference. See Pressure Prods. Med. Supplies, Inc. disclosure or there is insuf®cient disclosure of v. Greatbatch Ltd., 599 F.3d 1308, 1317, 94 USPQ2d structure, material, or acts for performing the claimed 1261, 1267 (Fed. Cir. 2010) (stating, ª[s]imply function; and/or mentioning prior art references in a patent does not suf®ce as a speci®cation description to give the (3) when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. patentee outright claim to all of the structures 112, sixth paragraph is invoked and the supporting disclosed in those references.º); Atmel Corp. v. Info. disclosure fails to clearly link or associate the Storage Devices, Inc., 198 F.3d 1374, 1381, 53 disclosed structure, material, or acts to the claimed USPQ2d 1225, 1230 (Fed. Cir. 1999). The disclosure function. must be reviewed from the point of view of one When the examiner cannot identify the skilled in the relevant art to determine whether that corresponding structure, material, or acts, a rejection person would understand the written description to under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, disclose the corresponding structure, material, or second paragraph should be made. In some cases, a acts. Tech. Licensing Corp. v. Videotek, Inc., 545 requirement for information under 37 CFR 1.105 F.3d 1316, 1338, 88 USPQ2d 1865, 1879 (Fed. Cir. may be made to require the identi®cation of the 2008); Med. Instrumentation & Diagnostics Corp. corresponding structure, material, or acts. See MPEP v. Elekta AB, 344 F.3d 1205, 1211-12, 68 USPQ2d § 704.11(a), Example R. If a requirement for 1263, 1269 (Fed. Cir. 2003). To satisfy the information under 37 CFR 1.105 is made and the de®niteness requirement under 35 U.S.C. 112(b) or applicant states that he or she lacks such information 35 U.S.C. 112, second paragraph, the written or the reply does not identify the corresponding description must clearly link or associate the structure, material, or acts, a rejection under 35 corresponding structure, material, or acts to the U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second claimed function. Telcordia Techs., Inc. v. Cisco paragraph should be made. For more information, Systems, Inc., 612 F.3d 1365, 1376, 95 USPQ2d see MPEP § 704.12 (ªReplies to requirements for 1673, 1682 (Fed. Cir. 2010). A rejection under 35 information must be complete and ®led within the U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second time period set including any extensions. Failure to paragraph is appropriate if the written description reply within the time period set will result in the fails to link or associate the disclosed structure, abandonment of the application.º). material, or acts to the claimed function, or if there is no disclosure (or insuf®cient disclosure) of If the written description sets forth the corresponding structure, material, or acts for performing the claimed structure, material, or acts in compliance with 35 function. Donaldson, 16 F.3d at 1195, 29 USPQ2d U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second at 1850. A bare statement that known techniques or paragraph, the claim limitation must ªbe construed methods can be used would not be a suf®cient to cover the corresponding structure, material, or disclosure to support a means-plus-function acts described in the speci®cation and equivalents limitation. Biomedino, LLC v. Waters Techs. Corp., thereof.º 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 490 F.3d 946, 953, 83 USPQ2d 1118, 1123 (Fed. 112, sixth paragraph. However, functional limitations Cir. 2007). that are not recited in the claim, or structural limitations from the written description that are A rejection under 35 U.S.C. 112(b) or pre-AIA 35 unnecessary to perform the claimed function, cannot U.S.C. 112, second paragraph may be appropriate be imported into the claim. Welker Bearing, 550 in the following situations when examining F.3d at 1097, 89 USPQ2d at 1294; Wenger Mfg., means-plus-function claim limitations under 35 Inc. v. Coating Mach. Sys., Inc., 239 F.3d 1225, 1233 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth (Fed. Cir. 2001). paragraph:

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The following guidance is provided to determine USPQ2d at 1885 (The function recited in the whether applicant has complied with the means-plus-function limitation involved requirements of 35 U.S.C. 112(b) or pre-AIA 35 ªreconstructingº data. The issue was whether the U.S.C. 112, second paragraph, when 35 U.S.C. structure underlying this ªreconstructingº function 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, was adequately described in the written description is invoked: to satisfy 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The court stated that (A) If the corresponding structure, material or ª[n]either the written description nor the claims uses acts are described in the speci®cation in speci®c the magic word `computer,' nor do they quote terms (e.g., an emitter-coupled voltage comparator), computer code that may be used in the invention. are linked to or associated with the claimed function Nevertheless, when the written description is and one skilled in the art could identify the structure, combined with claims 8 and 9, the disclosure material or acts from that description as being satis®es the requirements of Section 112, Para. 2.º adequate to perform the claimed function, then the The court concluded that based on the speci®c facts requirements of 35 U.S.C. 112(b) and (f) or pre-AIA of the case, one skilled in the art would recognize 35 U.S.C. 112, second and sixth paragraphs and are the structure for performing the ªreconstructingº satis®ed. See Atmel, 198 F.3d at 1382, 53 USPQ2d function since ªa unit which receives digital data, 1231. performs complex mathematical computations and (B) If the corresponding structure, material or outputs the results to a display must be implemented acts are described in the speci®cation in broad by or on a general or special purpose computer.º). generic terms and the speci®c details of which are See also Intel Corp. v. VIA Technologies, Inc, 319 incorporated by reference to another document (e.g., F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. attachment means disclosed in U.S. Patent No. X, 2003) (The ªcore logicº structure that was modi®ed which is hereby incorporated by reference, or a to perform a particular program was held to be comparator as disclosed in the Y article, which is adequate corresponding structure for a claimed hereby incorporated by reference), Of®ce personnel function although the speci®cation did not disclose must review the description in the speci®cation, internal circuitry of the core logic to show exactly without relying on any material from the how it must be modi®ed.) incorporated document, and apply the ªone skilled (2) If one skilled in the art would not be able in the artº analysis to determine whether one skilled to identify the structure, material or acts from in the art could identify the corresponding structure description in the speci®cation for performing the (or material or acts) for performing the recited recited function, then applicant will be required to function to satisfy the de®niteness requirement of amend the speci®cation to contain the material 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second incorporated by reference, including the clear link paragraph. See Default Proof Credit Card System, or associated structure, material or acts to the Inc. v. Home Depot U.S.A., Inc., 412 F.3d 1291, 75 function recited in the claim. See 37 CFR 1.57(c)(3). USPQ2d 1116 (Fed. Cir. 2005) (ªThe inquiry under Applicant should not be required to insert all of the [35 U.S.C.] § 112, ¶ 2, does not turn on whether a subject matter described in the entire referenced patentee has `incorporated by reference' material document into the speci®cation. To maintain a into the speci®cation relating to structure, but instead concise speci®cation, applicant should only include asks ®rst `whether structure is described in the the relevant portions of the referenced document that speci®cation, and, if so, whether one skilled in the correspond to the means- (or step-) plus-function art would identify the structure from that limitation. See Atmel, 198 F.3d at 1382, 53 USPQ2d description.'º). at 1230 (ªAll one needs to do¼is to recite some (1) If one skilled in the art would be able to structure corresponding to the means in the identify the structure, material or acts from the speci®cation¼so that one can readily ascertain what description in the speci®cation for performing the the claim means and comply with the particularity recited function, then the requirements of 35 U.S.C. requirement of Para. 2.º). 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, are satis®ed. See Dossel, 115 F.3d at 946-47, 42

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IV. DETERMINING WHETHER 35 U.S.C. 112(a) and drawings. See In re Mott, 539 F.2d 1291, 1299, or Pre-AIA 35 U.S.C. 112, FIRST PARAGRAPH 190 USPQ 536, 542±43 (CCPA 1976) (claims); In SUPPORT EXISTS re Anderson, 471 F.2d 1237, 1240, 176 USPQ 331, 333 (CCPA 1973) (claims); Hill-Rom Co. v. Kinetic A means- (or step-) plus-function limitation that is Concepts, Inc., 209 F.3d 1337, 54 USPQ2d 1437 found to be inde®nite under 35 U.S.C. 112(b) or (Fed. Cir. 2000) (unpublished) (abstract); In re pre-AIA 35 U.S.C. 112, second paragraph, based on Armbruster, 512 F.2d 676, 678±79, 185 USPQ 152, failure of the speci®cation to disclose corresponding 153±54 (CCPA 1975) (abstract); Anderson, 471 structure, material or act that performs the entire F.2d at 1240, 176 USPQ at 333 (abstract); Vas-Cath claimed function may also lack adequate written Inc. v. Mahurkar, 935 F.2d 1555, 1564, 19 USPQ2d description and/or not be suf®ciently enabled to 1111, 1117 (drawings); In re Wolfensperger, 302 support the full scope of the claim. The principal F.2d 950, 955±57, 133 USPQ 537, 541± 43 (CCPA function of claims is to provide notice of the 1962) (drawings). boundaries of the right to exclude by de®ning the limits of the invention, and means-plus-function Merely restating a function associated with a claims rely on the disclosure to de®ne those limits. means-plus-function limitation is insuf®cient to Accordingly, an inadequate disclosure may give rise provide the corresponding structure for de®niteness. to both an inde®niteness rejection for a See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at means-plus-function limitation and a failure to 1419; Blackboard, 574 F.3d at 1384; Aristocrat, satisfy the written description and enablement 521 F.3d at 1334, 86 USPQ2d at 1239. It follows requirements of section 112(a) or pre-AIA section therefore that such a mere restatement of function 112, ®rst paragraph. The Federal Circuit has in the speci®cation without more description of the recognized the problem of providing a suf®cient means that accomplish the function would also likely disclosure for functional claiming, particularly with fail to provide adequate written description under generic claim language, explaining that ªThe section 112(a) or pre-AIA section 112, ®rst problem is especially acute with genus claims that paragraph. use functional language to de®ne the boundaries of a claimed genus. In such a case, the functional claim 37 CFR 1.75(d)(1) provides, in part, that ªthe terms may simply claim a desired result, and may do so and phrases used in the claims must ®nd clear without describing species that achieve that result. support or antecedent basis in the description so that But the speci®cation must demonstrate that the the meaning of the terms in the claims may be applicant has made a generic invention that achieves ascertainable by reference to the description.º In the the claimed result and do so by showing that the situation in which the written description only applicant has invented species suf®cient to support implicitly or inherently sets forth the structure, a claim to the functionally-de®ned genus.º Ariad materials, or acts corresponding to a means- (or Pharmaceuticals Inc. v. Eli & Lilly Co., 598 F.3d step-) plus-function, and the examiner concludes 1336, 1349, 94 USPQ2d 1161, 1171 (Fed. Cir. 2010) that one skilled in the art would recognize what (en banc). structure, materials, or acts perform the function recited in a means- (or step-) plus-function, the Thus, the means- (or step-) plus- function claims examiner should either: (A) have the applicant clarify must still be analyzed to determine whether there the record by amending the written description such exists corresponding adequate support for such claim that it expressly recites what structure, materials, or under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, acts perform the function recited in the claim ®rst paragraph. In considering whether there is 35 element; or (B) state on the record what structure, U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst materials, or acts perform the function recited in the paragraph support for the claim limitation, the means- (or step-) plus-function limitation. Even if examiner must consider not only the original the disclosure implicitly sets forth the structure, disclosure contained in the summary and detailed materials, or acts corresponding to a means- (or description of the invention portions of the step-) plus-function claim element in compliance speci®cation, but also the original claims, abstract, with 35 U.S.C. 112(a) and (b) or pre-AIA 35 U.S.C.

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112, ®rst and second paragraphs, the USPTO may means known to the inventor. In re Hyatt, 708 F.2d still require the applicant to amend the speci®cation 712, 218 USPQ 195 (Fed. Cir. 1983). A single means pursuant to 37 CFR 1.75(d) and MPEP § 608.01(o) claim does not comply with 35 U.S.C. 112(a) or to explicitly state, with reference to the terms and pre-AIA 35 U.S.C. 112, ®rst paragraph requiring phrases of the claim element, what structure, that the enabling disclosure of the speci®cation be materials, or acts perform the function recited in the commensurate in scope with the claim under claim element in a manner that does not add consideration. As Donaldson applies only to an prohibited new matter to the speci®cation. See 35 interpretation of a limitation drafted to correspond U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth to 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (ªAn element in a claim for a combination paragraph, by its terms is limited to ªan element in may be expressed as a means or step for performing a claim for a combination.º Therefore, single means a speci®ed function without the recital of structure, claims that do not recite a combination cannot invoke material, or acts in support thereof, and such claim section 112(f) or pre-AIA section 112, sixth shall be construed to cover the corresponding paragraph. As such, they are not limited to the structure, material, or acts described in the structure, material or act disclosed in the speci®cation and equivalents thereof.º (emphasis speci®cation. Thus, a single means limitation that added)); see also B. Braun Medical, 124 F.3d at is properly construed will cover all means of 1424, 43 USPQ2d at 1900 (holding that ªpursuant performing the claimed function. A claim of such to this provision [35 U.S.C. 112, sixth paragraph], breadth reads on subject matter that is not enabled structure disclosed in the speci®cation is by the speci®cation, and therefore, should be rejected `corresponding' structure only if the speci®cation under section 112(a) or pre-AIA section 112, ®rst or prosecution history clearly links or associates that paragraph. See also MPEP § 2164.08(a). structure to the function recited in the claim. This duty to link or associate structure to function is the VI. ENSURE THAT THE RECORD IS CLEAR quid pro quo for the convenience of employing 112, paragraph 6.º); Medical Instrumentation and When an examiner interprets a claim limitation under Diagnostic Corp. v. Elekta AB, 344 F.3d 1205, 1218, the provisions of 35 U.S.C. 112(f) or pre-AIA 35 68 USPQ2d 1263, 1268 (Fed. Cir. 2003) (Although U.S.C. 112, sixth paragraph, the Of®ce action should one of skill in the art would have been able to write specify that the examiner has done so. When claim a software program for digital to digital conversion, terms other than ªmeansº or "step" are determined such software did not fall within the scope of ªmeans to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. for convertingº images as claimed because nothing 112, sixth paragraph, the reasons why the claim was in the speci®cation or prosecution history clearly interpreted as invoking 35 U.S.C. 112(f) or pre-AIA linked or associated such software with the function 35 U.S.C. 112, sixth paragraph, should also be of converting images into a selected format.); clearly stated in the Of®ce action. For example, the Wolfensperger, 302 F.2d at 955, 133 USPQ at 542 Of®ce action can include a statement that a certain (just because the disclosure provides support for a claim limitation is expressed in functional terms claim element does not mean that the USPTO cannot coupled to a generic placeholder (e.g., ªmodule for,º) enforce its requirement that the terms and phrases that does not connote structure and therefore invokes used in the claims ®nd clear support or antecedent treatment under 35 U.S.C. 112(f) or pre-AIA 35 basis in the written description). U.S.C. 112, sixth paragraph. When the examiner has determined that 35 U.S.C. 112(f) or pre-AIA 35 V. SINGLE MEANS CLAIMS U.S.C. 112, sixth paragraph applies, the examiner may also specify what the speci®cation identi®es as A single means claim is a claim that recites a the corresponding structure. means-plus-function limitation as the only limitation of a claim. The long-recognized problem with a The two rebuttable presumptions regarding the single means claim is that it covers every application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. conceivable means for achieving the stated result, 112, sixth paragraph, noted in subsection I., above, while the speci®cation discloses at most only those should be established in the prosecution record. If

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one of the presumptions is rebutted, an explanation explanation has not previously been made of record. of the reasons that the presumption is rebutted should As noted above, the indication should also clarify be provided on the record. In particular, clari®cation the associated structure if not readily apparent in the should be provided when the claim uses the word speci®cation. ªmeansº or "step" and section 112(f) or pre-AIA section 112, sixth paragraph, is not invoked or when 2182 Search and Identi®cation of the Prior the claim uses a substitute for the word ªmeansº or Art [R-11.2013] "step" (a generic placeholder) and section 112(f) or pre-AIA section 112, sixth paragraph, is invoked. The application of a prior art reference to a means- By this, the applicant and the public are noti®ed as (or step-) plus-function limitation requires that the to the claim construction used by the examiner prior art element perform the identical function during prosecution. Also, if the applicant intends a speci®ed in the claim. However, if a prior art different claim construction, the issue can be reference only teaches identity of function to that clari®ed early in prosecution. speci®ed in a claim, then an examiner carries the initial burden of proof for showing that the prior art The presumptions noted above are as follows. The structure or step is the same as or equivalent to the ®rst presumption is that use of the word ªmeansº or structure, material, or acts described in the "step" in a claim creates a rebuttable presumption speci®cation which has been identi®ed as that the claim element is to be treated in accordance corresponding to the claimed means- (or step-) with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, plus-function. sixth paragraph. The presumption is rebutted when ªmeansº or "step" is not modi®ed by function or The means- (or step-) plus- function limitation when the function is recited with suf®cient structure should be interpreted in a manner consistent with or material within the claim itself to perform the the speci®cation disclosure. The Federal Circuit recited function. The second presumption is that explained the two step analysis involved in absence of the word ªmeansº or "step" in a claim construing means- (or step-) plus- function creates a rebuttable presumption that the claim limitations in Golight Inc. v. Wal-Mart Stores Inc., element is not to be treated in accordance with 35 355 F.3d 1327, 1333-34, 69 USPQ2d 1481, 1486 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth (Fed. Cir. 2004): paragraph. The presumption is rebutted when the claim element recites function but fails to recite suf®ciently de®nite structure or material to perform The ®rst step in construing a that function. See MPEP § 706.03 for applicable means-plus-function claim limitation is to form paragraphs. Additionally, if the corresponding de®ne the particular function of the claim structure for the claimed function is not clearly limitation. Budde v. Harley-Davidson, Inc., identi®able in the speci®cation, the Of®ce action 250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806 should, nevertheless, attempt to identify what (Fed. Cir. 2001). ªThe court must construe the structure is most closely associated with the means- function of a means-plus-function limitation to (or step-) plus-function limitation to facilitate a prior include the limitations contained in the claim art search. This is especially true when there may language, and only those limitations.º Cardiac be confusion as to which disclosed implementation Pacemakers, Inc. v. St. Jude Med., Inc., 296 of the invention supports the limitation, as explained F.3d 1106, 1113, 63 USPQ2d 1725, 1730 (Fed. in subsection II.B., above. Cir. 2002). The next step in construing a means-plus-function claim limitation is to look to the speci®cation and identify the When allowing a claim that was treated under 35 corresponding structure for that function. U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth ªUnder this second step, `structure disclosed paragraph, the examiner should indicate that the in the speci®cation is ªcorrespondingº structure claim was interpreted under the provisions of 35 only if the speci®cation or prosecution history U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth clearly links or associates that structure to the paragraph in reasons for allowance if such an

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function recited in the claim.'º Med. (C) is an equivalent of the means- (or step-) Instrumentation & Diagnostics Corp. v. Elekta plus-function limitation, AB, 344 F.3d 1205, 1210, 68 USPQ2d 1263, the examiner should provide an explanation and 1267 (Fed. Cir. 2003) (quoting B. Braun Med. rationale in the Of®ce action as to why the prior Inc. v. Abbott Labs., 124 F.3d 1419, 1424, 43 art element is an equivalent. See In re Bond, 910 USPQ2d 1896, 1900 (Fed. Cir. 1997)). F.2d 831, 833, 15 USPQ2d 1566, 1568 (Fed. Cir. 1990) ("The disclosed and prior art structures are If the speci®cation de®nes what is meant by the not identical, but the claim may nonetheless be limitation for the purposes of the claimed invention, anticipated. ¼ However, the Board made no ®nding the examiner should interpret the limitation as having that the delay means of claim 1 and that embodied that meaning. If no de®nition is provided, some in the Curtis device are structurally equivalent. judgment must be exercised in determining the scope Accordingly, its decision as to the anticipation of of the limitation. See, e.g., B. Braun Medical, Inc. claim 1 is de®cient and must be vacated.º) v. Abbott Labs., 124 F.3d 1419, 1424, 43 USPQ2d 1896, 1900 (Fed. Cir. 1997) (ªWe hold that, pursuant Factors that will support a conclusion that the prior to [35 U.S.C. 112, sixth paragraph], structure art element is an equivalent are: disclosed in the speci®cation is `corresponding' structure only if the speci®cation or prosecution (A) the prior art element performs the identical history clearly links or associates that structure to function speci®ed in the claim in substantially the the function recited in the claim. This duty to link same way, and produces substantially the same or associate structure to function is the quid pro quo results as the corresponding element disclosed in the for the convenience of employing 112, paragraph speci®cation. Kemco Sales, Inc. v. Control Papers 6.º The court refused to interpret a Co., 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir. means-plus-function limitation as corresponding to 2000) (An internal adhesive sealing the inner a disclosed valve seat structure, as argued by surfaces of an envelope pocket was not held to be patentee, since there was no indication in the equivalent to an adhesive on a ¯ap which attached speci®cation or prosecution history that this structure to the outside of the pocket. Both the claimed corresponds to the recited function, and there was invention and the accused device performed the same an explicitly clear association between that function function of closing the envelope. But the accused and a traverse cross section bar structure disclosed device performed it in a substantially different way in the speci®cation.). (by an internal adhesive on the inside of the pocket) with a substantially different result (the adhesive 2183 Making a Prima Facie Case of attached the inner surfaces of both sides of the Equivalence [R-11.2013] pocket)); Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United [Editor Note: This MPEP section is applicable to States, 193 USPQ 449, 461 (Ct. Cl. 1977). The applications subject to the ®rst inventor to ®le concepts of equivalents as set forth in Graver Tank (FITF) provisions of the AIA except that the relevant & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 date is the "effective ®ling date" of the claimed USPQ 328 (1950) are relevant to any ªequivalentsº invention instead of the "time of the invention," determination. Polumbo v. Don-Joy Co., 762 F.2d which is only applicable to applications subject to 969, 975 n.4, 226 USPQ 5, 8-9 n.4 (Fed. Cir. 1985). pre-AIA 35 U.S.C. 102. See 35 U.S.C. 100 (note) and MPEP § 2150 et seq.] (B) a person of ordinary skill in the art would have recognized the interchangeability of the element If the examiner ®nds that a prior art element shown in the prior art for the corresponding element disclosed in the speci®cation. Caterpillar Inc. v. (A) performs the function speci®ed in the claim, Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int' l, Inc., (B) is not excluded by any explicit de®nition 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. provided in the speci®cation for an equivalent, and Cir. 1999); Chiuminatta Concrete Concepts, Inc.

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v. Cardinal Indus. Inc., 145 F.3d 1303, 1309, 46 equivalents is required of the examiner until USPQ2d 1752, 1757 (Fed. Cir. 1998); Lockheed applicant disagrees with the examiner's conclusion, Aircraft Corp. v. United States, 193 USPQ 449, 461 and provides reasons why the prior art element (Ct. Cl. 1977 ); Data Line Corp. v. Micro should not be considered an equivalent. See also In Technologies, Inc., 813 F.2d 1196, 1 USPQ2d 2052 re Walter, 618 F.2d 758, 768, 205 USPQ 397, (Fed. Cir. 1987). 407-08 (CCPA 1980) (treating 35 U.S.C. 112, sixth (C) there are insubstantial differences between paragraph, in the context of a determination the prior art element and the corresponding element of statutory subject matter and noting ª[i]f disclosed in the speci®cation. IMS Technology, Inc. the functionally-de®ned disclosed means and their v. Haas Automation, Inc., 206 F.3d 1422, 1436, equivalents are so broad that they encompass any 54 USPQ2d 1129, 1138 (Fed. Cir. 2000); and every means for performing the recited functions Warner-Jenkinson Co. v. Hilton Davis Chemical . . . the burden must be placed on the applicant to Co., 117 S. Ct. 1040, 41 USPQ2d 1865, 1875 demonstrate that the claims are truly drawn to (1997); Valmont Industries, Inc. v. Reinke Mfg. speci®c apparatus distinct from other apparatus Co., 983 F.2d 1039, 25 USPQ2d 1451 (Fed. Cir. capable of performing the identical functionsº); In 1993). See also Caterpillar Inc. v. Deere & Co., re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000) 229 (CCPA 1971) (treating as improper a rejection (A structure lacking several components of the under 35 U.S.C. 112, second paragraph, of functional overall structure corresponding to the claimed language, but noting that ªwhere the Patent Of®ce function and also differing in the number and size has reason to believe that a functional limitation of the parts may be insubstantially different from asserted to be critical for establishing novelty in the the disclosed structure. The limitation in a means- claimed subject matter may, in fact, be an inherent (or step-) plus-function claim is the overall structure characteristic of the prior art, it possesses the corresponding to the claimed function. The authority to require the applicant to prove that the individual components of an overall structure that subject matter shown to be in the prior art does not corresponds to the claimed function are not claim possess the characteristics relied onº); In limitations. Also, potential advantages of a structure re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA that do not relate to the claimed function should not 1980) (indicating that the burden of proof can be be considered in an equivalents determination under shifted to the applicant to show that the subject 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth matter of the prior art does not possess the paragraph). characteristic relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness A showing of at least one of the above-noted factors under 35 U.S.C. 103). by the examiner should be suf®cient to support a conclusion that the prior art element is an equivalent. See MPEP § 2184 when determining whether the The examiner should then conclude that the claimed applicant has successfully met the burden of proving limitation is met by the prior art element. In addition that the prior art element is not equivalent to the to the conclusion that the prior art element is an structure, material or acts described in the applicant's equivalent, examiners should also demonstrate, speci®cation. where appropriate, why it would have been obvious to one of ordinary skill in the art at the time of the IF NONEQUIVALENCE SHOWN, EXAMINER invention to substitute applicant's described MUST CONSIDER OBVIOUSNESS structure, material, or acts for that described in the prior art reference. See In re Brown, 459 F.2d 531, However, even where the applicant has met that 535, 173 USPQ 685, 688 (CCPA 1972). The burden burden of proof and has shown that the prior art then shifts to applicant to show that the element element is not equivalent to the structure, material shown in the prior art is not an equivalent of the or acts described in the applicant's speci®cation, the structure, material or acts disclosed in the examiner must still make a 35 U.S.C. 103 analysis application. In re Mulder, 716 F.2d 1542, 219 USPQ to determine if the claimed means- (or step-) 189 (Fed. Cir. 1983). No further analysis of plus-function is obvious from the prior art to one of

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ordinary skill in the art. Thus, while a ®nding of If the applicant disagrees with the inference of nonequivalence prevents a prior art element from equivalence drawn from a prior art reference, the anticipating a means- (or step-) plus-function applicant may provide reasons why the applicant limitation in a claim, it does not prevent the prior art believes the prior art element should not be element from rendering the claim limitation obvious considered an equivalent to the speci®c structure, to one of ordinary skill in the art. Because the exact material or acts disclosed in the speci®cation. Such scope of an ªequivalentº may be uncertain, it would reasons may include, but are not limited to: be appropriate to apply a 35 U.S.C. 102/103 rejection where the balance of the claim limitations are (A) Teachings in the speci®cation that particular anticipated by the prior art relied on. A similar prior art is not equivalent; approach is authorized in the case of (B) Teachings in the prior art reference itself product-by-process claims because the exact identity that may tend to show nonequivalence; or of the claimed product or the prior art product cannot be determined by the examiner. In re Brown, (C) 37 CFR 1.132 af®davit evidence of facts 450 F.2d 531, 173 USPQ 685 (CCPA 1972). In tending to show nonequivalence. addition, although it is normally the best practice to I. TEACHINGS IN APPLICANT'S SPECIFICATION rely on only the best prior art references in rejecting a claim, alternative grounds of rejection may be When the applicant relies on teachings in applicant's appropriate where the prior art shows elements that own speci®cation, the examiner must make sure that are different from each other, and different from the the applicant is interpreting the means- (or step-) speci®c structure, material or acts described in the plus- function limitation in the claim in a manner speci®cation, yet perform the function speci®ed in which is consistent with the disclosure in the the claim. speci®cation. If the speci®cation de®nes what is meant by ªequivalentsº to the disclosed 2184 Determining Whether an Applicant embodiments for the purpose of the claimed means- Has Met the Burden of Proving (or step-) plus- function, the examiner should Nonequivalence After a Prima Facie Case Is interpret the limitation as having that meaning. If no Made [R-11.2013] de®nition is provided, some judgment must be exercised in determining the scope of ªequivalents.º The speci®cation need not necessarily describe the Generally, an ªequivalentº is interpreted as equivalents of the structures, material, or acts embracing more than the speci®c elements described corresponding to the means-(or step-) plus-function in the speci®cation for performing the speci®ed claim element. See In re Noll, 545 F.2d 141, 149-50, function, but less than any element that performs the 191 USPQ 721, 727 (CCPA 1976) (if the meaning function speci®ed in the claim. See, e.g., NOMOS of equivalents is well understood in patent law, then Corp. v. BrainLAB USA Inc., 357 F.3d, 1364, 1368, an applicant need not describe in his speci®cation 69 USPQ2d 1853, 1856 (Fed. Cir. 2004) (where only the full range of equivalents of his invention). one embodiment is described, the corresponding Cf. Hybritech Inc. v. Monoclonal Antibodies, Inc., structure is limited to that embodiment and 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. equivalents thereof). To interpret means- (or step-) 1986) (ªa patent need not teach, and preferably plus-function limitations as limited to a particular omits, what is well known in the artº). Where, means (or step) set forth in the speci®cation would however, the speci®cation is silent as to what nullify the provisions of 35 U.S.C. 112 requiring constitutes equivalents and the examiner has made that the limitation shall be construed to cover the out a prima facie case of equivalence, the burden structure described in the speci®cation and is placed upon the applicant to show that a prior art equivalents thereof. D.M.I., Inc. v. Deere & Co., element which performs the claimed function is not 755 F.2d 1570, 1574, 225 USPQ 236, 238 (Fed. Cir. an equivalent of the structure, material, or acts 1985). disclosed in the speci®cation. See In re Mulder, 716 F.2d 1542, 1549, 219 USPQ 189, 196 (Fed. Cir. The scope of equivalents embraced by a claim 1983). limitation is dependent on the interpretation of an

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ªequivalent.º The interpretation will vary depending describes the invention only in the context of a on how the element is described in the supporting speci®c structure, material or act that is used to speci®cation. The claim may or may not be limited perform the function speci®ed in the claim. to particular structure, material or acts (e.g., steps) as opposed to any and all structure, material or acts II. FACTORS TO BE CONSIDERED IN DECIDING performing the claimed function, depending on how EQUIVALENCE the speci®cation treats that question. See, e.g., Ishida Co. v. Taylor, 221 F.3d 1310, 55 USPQ2d When deciding whether an applicant has met the 1449 (Fed. Cir. 2000) (The court construed the scope burden of proof with respect to showing of a means-plus-function claim element where the nonequivalence of a prior art element that performs speci®cation disclosed two structurally very different the claimed function, the following factors may be embodiments for performing the claimed function considered. First, unless an element performs the by looking separately to each embodiment to identical function speci®ed in the claim, it cannot determine corresponding structures. The court be an equivalent for the purposes of 35 U.S.C. 112(f) declined to adopt a single claim construction or pre-AIA 35 U.S.C. 112, sixth paragraph. encompassing both embodiments since it would be Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d so broad as to describe systems both with and 931, 4 USPQ2d 1737 (Fed. Cir. 1987), cert. denied, without the fundamental structural features of each 484 U.S. 961 (1988). embodiment.). Second, while there is no litmus test for an If the disclosure is so broad as to encompass any and ªequivalentº that can be applied with absolute all structures, materials or acts for performing the certainty and predictability, there are several indicia claimed function, the claims must be read that are suf®cient to support a conclusion that one accordingly when determining patentability. When element is or is not an ªequivalentº of a different this happens the limitation otherwise provided by element in the context of 35 U.S.C. 112(f) or ªequivalentsº ceases to be a limitation on the scope pre-AIA 35 U.S.C. 112, sixth paragraph. Indicia that of the claim in that an equivalent would be any will support a conclusion that one element is or is structure, material or act other than the ones not an equivalent of another are set forth in MPEP described in the speci®cation that perform the § 2183. claimed function. For example, this situation will often be found in cases where (A) the claimed III. MERE ALLEGATIONS OF invention is a combination of elements, one or more NONEQUIVALENCE ARE NOT SUFFICIENT of which are selected from elements that are old, per se, or (B) apparatus claims are treated as In determining whether arguments or 37 CFR 1.132 indistinguishable from method claims. See, for evidence presented by an applicant are persuasive example, In re Meyer, 688 F.2d 789, 215 USPQ that the element shown in the prior art is not an 193 (CCPA 1982); In re Abele, 684 F.2d 902, 909, equivalent, the examiner should consider and weigh 214 USPQ 682, 688 (CCPA 1982); In re Walter, as many of the above-indicated or other indicia as 618 F.2d 758, 767, 205 USPQ 397, 406-07 (CCPA are presented by applicant, and should determine 1980); In re Maucorps, 609 F.2d 481, 203 USPQ whether, on balance, the applicant has met the 812 (CCPA 1979); In re Johnson, 589 F.2d 1070, burden of proof to show nonequivalence. However, 200 USPQ 199 (CCPA 1978); and In re Freeman, under no circumstance should an examiner accept 573 F.2d 1237, 1246, 197 USPQ 464, 471 (CCPA as persuasive a bare statement or opinion that the 1978). element shown in the prior art is not an equivalent embraced by the claim limitation. Moreover, if an On the other end of the spectrum, the ªequivalentsº applicant argues that the means- (or step-) limitation as applied to a claim may also operate to plus-function language in a claim is limited to certain constrict the claim scope to the point of covering speci®c structural or additional functional virtually only the disclosed embodiments. This can characteristics (as opposed to ªequivalentsº thereof) happen in circumstances where the speci®cation where the speci®cation does not describe the

Rev. 07.2015, October 2015 2100-330 PATENTABILITY § 2185

invention as being only those speci®c characteristics, (A) under 35 U.S.C. 112(a) or pre-AIA 35 the claim should not be allowed until the claim is U.S.C. 112, ®rst paragraph, as not being supported amended to recite those speci®c structural or by an enabling disclosure because the person skilled additional functional characteristics. Otherwise, a in the art would not know how to make and use the claim could be allowed having broad functional invention without a description of elements to language which, in reality, is limited to only the perform the function. Note that the description of an speci®c structure or steps disclosed in the apparatus with block diagrams describing the speci®cation. This would be contrary to public policy function, but not the structure, of the apparatus is of granting patents which provide adequate notice not fatal under the enablement requirement of 35 to the public as to a claim's true scope. U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, as long as the structure is conventional IV. APPLICANT MAY AMEND CLAIMS and can be determined without an undue amount of experimentation. In re Ghiron, 442 F.2d 985, 991, Finally, as in the past, applicant has the opportunity 169 USPQ 723, 727 (CCPA 1971); during proceedings before the Of®ce to amend the (B) under 35 U.S.C. 112(a) or pre-AIA 35 claims so that the claimed invention meets all the U.S.C. 112, ®rst paragraph as lacking adequate statutory criteria for patentability. An applicant may written description because the speci®cation does choose to amend the claim by further limiting the not describe the claimed invention in suf®cient detail function so that there is no longer identity of function that one skilled in the art can reasonably conclude with that taught by the prior art element, or the that the inventor had possession of the claimed applicant may choose to replace the claimed means- invention. As an example, if the means- (or step-) (or step-) plus-function limitation with speci®c plus-function limitation is computer-implemented, structure, material or acts that are not described in and the speci®cation does not provide a disclosure the prior art. of the computer and algorithm in suf®cient detail to demonstrate to one of ordinary skill in the art that 2185 Related Issues Under 35 U.S.C. 112(a) the inventor possessed the invention including how or (b) and Pre-AIA 35 U.S.C. 112, First or to program the disclosed computer to perform the Second Paragraphs [R-07.2015] claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, ®rst paragraph, for lack Interpretation of claims as set forth in MPEP § 2181 of written description must be made; may create some uncertainty as to what applicant (C) under 35 U.S.C. 112(b) or pre-AIA 35 regards as the invention. If this issue arises, it should U.S.C. 112, second paragraph, as being inde®nite. be addressed in a rejection under 35 U.S.C. 112(b) See Biomedino, LLC v. Waters Technology Corp., or pre-AIA 35 U.S.C. 112, second paragraph. While 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth Cir. 2007), In re Dossel, 115 F.3d 942, 946, paragraph, permits a particular form of claim 42 USPQ2d 1881, 1884 (Fed. Cir. 1997) and MPEP limitation, it cannot be read as creating an exception § 2181; and either to the description, enablement or best mode (D) under 35 U.S.C. 102 or 103 where the prior requirements of 35 U.S.C. 112(a) or pre-AIA 35 art anticipates or renders obvious the claimed subject U.S.C. 112, ®rst paragraph or the de®niteness matter including the means or step that performs the requirement of 35 U.S.C. 112(b) or pre-AIA 35 function speci®ed in the claim, the theory being that U.S.C. 112, second paragraph. In re Knowlton, 481 since there is no corresponding structure, etc., in the F.2d 1357, 178 USPQ 486 (CCPA 1973). speci®cation to limit the means- (or step-) plus- If a means- (or step-) plus-function limitation recited in a claim is not supported by corresponding structure, material or acts in the speci®cation disclosure, the following rejections should be considered:

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function limitation, an equivalent is any element that of prosecution history laches for unreasonable and performs the speci®ed function. undue delay in prosecution. In re Bogese, 303 F.3d 2186 Relationship to the Doctrine of 1362, 1369, 64 USPQ2d 1448, 1453 (Fed. Cir. 2002) (Applicant ª®led twelve continuation applications Equivalents [R-11.2013] over an eight-year period and did not substantively advance prosecution when required and given an The doctrine of equivalents arises in the context of opportunity to do so by the PTO.º). While there are an infringement action. If an accused product or no ®rm guidelines for determining when laches is process does not literally infringe a patented triggered, it applies only in egregious cases of invention, the accused product or process may be unreasonable and unexplained delay in prosecution. found to infringe under the doctrine of equivalents. For example, where there are ªmultiple examples of The essential objective inquiry is: ªDoes the accused repetitive ®lings that demonstrate a pattern of product or process contain elements identical or unjusti®ed delayed prosecution,º laches may be equivalent to each claimed element of the patented triggered. Symbol Tech. Inc. v. Lemelson Med., invention?º Warner-Jenkinson Co. v. Hilton Davis Educ., & Research Found., 422 F.3d 1378, 1385, Chemical Co., 117 S. Ct. 1040, 41 USPQ2d 1865, 76 USPQ2d 1354, 1360 (Fed. Cir. 2005)(Court 1875 (1997). In determining equivalence, ª[a]n discussed difference between legitimate reasons for analysis of the role played by each element in the re®ling patent applications and re®lings for the context of the speci®c patent claim will thus inform business purpose of delaying the issuance of the inquiry as to whether a substitute element previously allowed claims.). An examiner should matches the function, way, and result of the claimed obtain approval from the TC Director before making element, or whether the substitute plays a role a rejection on the grounds of prosecution history substantially different from the claimed element.º laches. 41 USPQ2d at 1875.

35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, permit means- (or step-) plus-function limitations in claims to combinations, ªwith the proviso that application of the broad literal language of such claims must be limited to only those means that are `equivalent' to the actual means shown in the patent speci®cation. This is an application of the doctrine of equivalents in a restrictive role, narrowing the application of broad literal claim elements.º 41 USPQ2d at 1870. Accordingly, decisions involving the doctrine of equivalents should be considered, but should not unduly in¯uence a determination under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, during ex parte examination. See MPEP § 2183.

2187 -2189 [Reserved]

2190 Prosecution Laches [R-08.2012]

The Federal Circuit af®rmed a rejection of claims in a patent application on the ground that applicant had forfeited his right to a patent under the doctrine

Rev. 07.2015, October 2015 2100-332