F.3d 1269, 1276-77 (Fed. Cir. 2013) citing Diehr at 181. Tension exists between the If Flook and Diehr are Guidepost, broadness of § 101 and the judicially cre- ated exceptions; courts to date, have been where are we going? unable to decide whether the exceptions are to be read narrowly or as they were broadly written in §101. “If carried to its extreme, When is a process patentable? [the judicial exceptions] make all inven- tions unpatentable because all inventions BY R. LEE VAIL OF KEAN MILLER LLP Laboratories, Inc., 130 S.Ct. 3543 can be reduced to underlying principles (2010). The subsequent decision by the of nature which, once known, make their Lee Vail is an associate in the New Orleans United States Court of Appeal – Federal implementation obvious.” 450 U.S at 189, office of Kean Miller LLP. He joined the Circuit was appealed and upon return to FN12. The opinions in Diehr and Flook are firm in 2010 and practices in the intellectual the Supreme Court, Mayo Collaborative supposed to provide guidance in resolving property, patent, and corporate litigation Services v. Prometheus Laboratories, Inc., this tension; unfortunately they don’t. groups. He is a Registered Professional 132 S.Ct. 1289 (2012), the Court declared Diehr and Flook both applied the knowl- Engineer in Louisiana and Wisconsin. Lee that Flook and Diehr were “cases most edge gained through a calculation to new is also a registered Patent Attorney and directly on point, both addressed processes and useful ends; the calculation directed a is licensed to practice before the United using mathematical formulas that, like laws subsequent helpful activity. Flook referred States Patent and Trademark Office. His of nature, are not themselves patentable.” to this action as a post-solution activity.3 patent practice includes the prosecution 132 S.Ct. at 1292. A major finding of Flook was that “[t]he of patent applications, and patentability Flook stood for patent ineligible incor- notion that post-solution activity, no matter research and requirements. Prior to joining poration of mathematical algorithms, Diehr how conventional or obvious in itself, can Kean Miller, Lee served as Manager of stood for the converse. Both of the last two transform an unpatentable principle into Environmental Affairs for a worldwide oil Supreme Court decisions concerning pro- a patentable process exalts form over sub- and gas company. He can be reached at lee. cess patents held that process patent eligi- stance.” 437 U.S. at 590 (emphasis added). [email protected] bility was to be guided by Flook and Diehr. The Flook majority did not reject patent- Thus, via simple compare and contrast of ability of process relying on these judicially Flook and Diehr, it should be possible to excluded concerns per se. Inventive appli- hoever invents or discovers any establish criteria for patent eligibility. cation of a law of nature or a mathematical “ new and useful process, , algorithm may be patent eligible. See 437 manufacture, or composition of W PATENTABLE PROCESSES – U.S. at 594. The Flook Court recognized matter, or any new and useful improve- FLOOK AND DIEHR the patent eligibility of various machines ment thereof, may obtain a patent therefor, that rely on formulas and laws of natures: subject to the conditions of this title.” 35 Flook and Diehr were decided less than patents for adjustments to paper machines U.S.C. § 101. Although a simple state- three years apart; both applied mathemati- to better take advantage of gravity4; a new ment, the courts have failed to develop a cal algorithms to chemical processes. The chemical process based on a known prin- consistent criteria or guidepost to interpret patent issued to Mr. Flook was for a method ciple5; and an improved antenna that used this language. In 2008, the Federal Circuit to reset a process alarm in a chemical known equations to improve the design.6 attempted to develop a patent eligibility manufacturing process based on measured These prior inventions used equations and criterion by establishing the “machine-or- conditions. Mr. Diehr’s patent was for a laws of nature to create better machines transformation test.”1 While rejecting this method of manufacturing rubber and con- (not processes); thus Flook does not guide test as a rule, the Supreme Court agreed tained a calculation to reset the reaction us as to patentability of processes, except in Bilski v. Kappos, 130 S.Ct. 3218 (2010), time based on measured conditions. The that the post-solution activity may not be “that the machine-or-transformation test Court decided that the method of resetting . [was] a useful and important clue.”2 The the process alarm was not patent eligible, conventional or obvious Court said that a process or method patent while the method relating to the manu- The patent at issue in Flook was titled that did not involve a machine or trans- facture of rubber was patent eligible. The “Method for Updating Alarm Limits.” As formation might nonetheless be patent- majority in Flook did not see eye to eye with described by the Court, able, but failed to say when or how. While the majority in Diehr; the Flook authors An “alarm limit” is a number. During declining to further define eligible process wrote the dissent in Diehr and vice versa. catalytic conversion processes, oper- patents, the Court referred back to the Written from opposite points of view, the ating conditions such as tempera- “guideposts” of Parker v. Flook, 437 U.S. two cases together lack continuity. ture, pressure, and flow rates are 584 (1978) and Diamond v. Diehr, 450 U.S. “While the categories of patent-eligible constantly monitored. When any of 175 (1981). 130 S.Ct. at 3231. Since Flook subject matter recited in § 101 are broad, these “process variables” exceeds and Diehr are guidepost, they must be tell- their scope is limited by three important a predetermined “alarm limit,” an ing us which way to go. judicially created exceptions. ‘[L]aws of alarm may signal the presence of an Concurrent with the decision in Bilski, nature, natural phenomena, and abstract abnormal condition indicating either the Court vacated and remanded Mayo ideas’ are excluded from patent eligibility.” inefficiency or perhaps danger. Fixed Collaborative Services v. Prometheus CLS Bank Int’l v. Alice Corp. Pty. Ltd., 717 alarm limits may be appropriate for a

INTELLECTUAL PROPERTY TODAY OCTOBER, 2013 27 steady operation, but during transient involved in this case. 450 U.S. at than abstract ideas based on use of escrow operating situations, such as start-up, 215. accounts and record keeping associated it may be necessary to “update” the Jumping forward to Mayo, the Court with the settling of transactions. However, alarm limits periodically.7 stated that the inventor’s claim for patent- the Court failed to agree on the reasoning as In practice, at the time of Flook, after ability “is weaker than Diehr’s patent- to why such claims were ineligible subject an alarm limit was reached, a unit operator eligible claim and no stronger than Flook’s matter with the judges evenly split regard- responded to the alarm, at the very least by unpatentable one.” 132 S.Ct. at 1292. ing the eligibility of comparable computer acknowledging the alarm. If the operator Since Diehr, the Court has maintained the systems claims. assigned to monitor the alarm decides that distinction over and over; Diehr’s post- The panel of ten Federal Circuit Justices action is necessary, they will respond to solution activity was significant, whereas was so fractured in their reasoning that the the alarm by changing some process vari- Flook’s was not.8 In Mayo, the Court invali- “decision” constitutes six separate opin- able to mitigate undesirable consequences. dated the patent through the use of a ions. In the most basic sense, the Judges The information (that an alarm level had judicially created exclusion by ruling that agreed that prior Supreme Court prec- been reached), is visually or audible com- the process was based on a law of nature. edent require that patent claims contain- municated to an individual whose job it is Although it was proposed that the Mayo ing abstract ideas must have meaningful to make control decisions. That individual claims contained other non-law of nature limitations. However, a group of five Judges may decide to make a number of different elements such as administering drugs and (Lourie, Dyk, Prost, Reyna, and Wallach) process adjustments or to do nothing. measuring the results, the court was unper- rejected patent eligibility of the computer The Supreme Court rejected Flook’s suaded, holding: system claims, concluding that incorpora- tion of the method into a computer program method claim; “respondent’s application [these] step[s] tells doctors to engage was an insufficient limitation. This opinion simply provides a new and presumably in well-understood, routine, conven- begins with a statement consistent with better method for calculating alarm limit tional activity previously engaged in Flook and Mayo; “Limitations that repre- values.” 437 U.S. at 594. Inventive appli- by scientists who work in the field. sent a human contribution but are merely cation of a law of nature or a mathematical Purely “conventional or obvious” tangential, routine, well-understood, or con- formula may support a patent, but there “[pre]-solution activity” is normally ventional, or in practice fail to narrow the must be “some other inventive concept in not sufficient to transform an unpat- claim relative to the fundamental principle its application.” Id. Less than three years entable law of nature into a patent- therein, cannot confer patent eligibility.” later, a different majority would distinguish eligible application of such a law. 717 F.3d at 1269. CLS Bank is consistent Diehr from Flook by declaring that the post- 132 S.Ct. at 1298. with Flook and Mayo: all emphasize non- solution activity of Flook was insignificant. Thus the Court in Mayo returned to patentability of convention human activity. “Inventive concept” was mandatory under Flook; processes that rely on judicially CLS Bank extrapolates on prior opinions Flook, the only mention of the term in Diehr excluded concepts and otherwise contain noting that computers “have routinely been was in the dissent. conventional and obvious steps are not adapted by software consisting of abstract The similarities between Flook and patentable. Mayo’s patentability “was no ideas, and claimed as such, to do all sort of Diehr are striking, especially from the stronger than Flook’s.” 132 S.Ct. at 1292. task that formally were done by humans.” view of Diehr’s dissenting Justices. From This is consistent with Flook as the alarm 717 F.3d at 1291. This implication seems the majority’s viewpoint, Diehr patented provided information; implicit is that the to contradict long standing caselaw which a method of producing rubber (i.e., trans- operator should consider the alarm when has held that new computer software indeed forming matter) that used a repetitive cal- making operational decisions. Similarly, creates a new computer. In re Alappat, 33 culation to determine the proper cure time. the final step in the Mayo patent, “simply F.3d 1526 (Fed. Cir 1994). The opinion of The claims of Diehr included steps of gath- tell[s] a doctor that they should consider the five Judges strongly denote their belief ering temperature data for insertion into a the test results when making their treatment that recent Supreme Court decisions may formula that calculates the time required decision.” 132 S.Ct. at 1291. In the end, have overturned Alappat and, in light of for the rubber to cure. As soon as the time both patents provided information to allow the possible overruling of Allapat, that the required matches the time that the rubber a trained person to make a better decision. incorporation of a computer program into actually cured, a signal is sent to open the Both were not patent eligible subject mat- a computer, relying on an abstract idea, is press. 450 U.S. at 177; also see FN 5. The ter. not patent eligible. A second group of four minority however saw little difference in the Judges concluded that the “system claims two patents. FEDERAL CIRCUIT IN VIEW OF are indistinguishable from those in Diehr.” In its effort to distinguish Flook from BILSKI AND MAYO 717 F.3d at 1311. the instant case, the Court char- On May 10, 2013, the Federal Circuit, Although the system claims (contain- acterizes that postsolution activity sitting en banc, handed down its opinion in ing a computer) are similar to Diehr, they as “insignificant,” ante, at 1059, CLS Bank Int’l v. Alice Corp. The majority are distinguishable. The final step of the or as merely “token” activity, ante, of the Federal Circuit judges agreed on little Diehr claim results in a signal routed to at 1059, n. 14. As a practical mat- other than that the method and computer- a machine which performs a manufactur- ter however, the postsolution activity readable medium claims involved in the ing function; the Diehr invention controls described in the Flook application dispute were patent ineligible. Essentially, a machine. The final step of CLS Bank’s was no less significant than the auto- Alice Corporation owned patents that the system claim generates an instruction to an matic opening of the curing mold Federal Circuit found to be nothing more exchange institution to reconcile the party’s

28 INTELLECTUAL PROPERTY TODAY OCTOBER, 2013 accounts. Signals that operate a machine matter. By definition, however, per- ing patentable subject matter for process may be distinguishable from signals that forming operations, even known patents, is “reproducibility of results.” give instructions to bookkeepers. types of steps, on, or to create, In another recent case, Ass’n for novel, i.e., transformed subject REPRODUCIBILITY OF RESULTS Molecular Pathology v. U.S. Patent & matter is the stuff of which most Patent law embodies a process for allow- Trademark Office, 689 F.3d 1303 (Fed. process or method inventions ing the inventor to benefit for a period of Cir. 2012), the Federal Circuit allowed consists. 689 F.3d at 1336. years from his innovation for the price of one method claim while rejecting five The five disallowed method claims were fully disclosing to the public the extent of related, but distinguishable method claims. too similar to Prometheus’ claims in Mayo his discovery.9 Disclosures must comply Although the Supreme Court rendered a to survive. The five disallowed claims are with the enablement requirement contained further decision in the case it did not consistent with the findings in Flook, as in the first paragraph of 35 U.S.C. 112: involve the allowed method claim allowing the method only gathered information that The specification shall contain a an opportunity to examine rejected and required a subsequent human intervention. written description of the invention, allowed patent claims, side by side. Conversely, Claim 20 contained information and the manner and process of mak- Myriad Genetics, Inc., was the holder of gathering steps that depended on materials ing and using it, in such full, clear, multiple patents concerning the isolation that was made or transformed by humans. concise, and exact terms as to enable of deoxyribonucleic acid (DNA) sequences Diehr required the gathering of information any person skilled in the art to which associated with predisposition to breast to create a man made material, rubber. In it pertains, or with which it is most and ovarian cancers. These patents also this sense, although not stated as such, nearly connected, to make and use contained method claims for determining the guidepost of Flook and Diehr appear the same and shall set forth the best alterations or mutations in individual sam- to have guided the way. Furthermore, by mode contemplated by the inventor of ples. Five method claims were rejected; the allowing Claim 20 from “282” patent, the carrying out his invention. Federal Circuit found them indistinguish- Federal Circuit has tacitly reaffirmed their Scientific inquiry within the scientific able from Prometheus’ claims in Mayo. machine-or-transformation test. community proceeds along a similar path. Id. at 1335. The rejected claims typically After the scientist has formulated and tested comprised steps that included screening, his hypotheses, he publishes his results, comparing, and analyzing. Conversely, the FLOOK V. DIEHR with sufficient methodological information Federal Circuit allowed claim 20 of U.S. Considering the Diehr patent and the so that others in the scientific community Patent 5,747,282 (the “282” patent), a Flook patent as a whole, it is obvious that can attempt to replicate the experiments. claim “directed to a method for screening only a single difference exists between the Publication of a patent application (or potential cancer therapeutics via changes two methods; Flook returned the calculated issued patent) or of a technical paper starts in cell growth rates of transformed cells.” number to a human requiring human atten- a chain of activities where others attempt Id. Steps within the claim included grow- tion whereas the Diehr patent returned the to reproduce the experiments or method ing host cells, transformed with an altered calculated information to a machine as to find out if the “enabled” methodology gene, in the presence of a potential can- operating instructions. The result of the results in repeatable or concrete results. cer therapeutic, and comparing the growth Diehr patent was a process that proceeded “The process must have a result that can rates to similarly transformed cells that to a predictable result. The result of the be substantially repeatable or the process were not exposed to the potential drug (i.e., Flook patent was to suggest to an operator must substantially produce the same result a control). Id. at 1336. that he needed to think about what happens again.” MPEP 2106.IV.C.2(2)(c). next and the result is dependent on his Mayo taught, consistent with Flook, As with Flook before it, Mayo required method claims must do more than state an judgment and actions. that the output from a law of nature10 be abstract idea or a law of nature and then Considering Diehr, had Flook sent the placed in human hands with the “sugges- add the words “apply it.” 132 S.Ct at 1294. alarm signal to a processor (such as a tion that [the doctor] should take those laws The Federal Circuit held in this case: modern distributive control system with into account when treating his patients.” Here, claim 20 does do more; it does regulatory capability) with process operat- 132 S.Ct. at 1297. In applying the Flook not simply apply a law of nature. Of ing instructions to address the alarm, it process, the operator receives a number and course, all activity, whether chemi- would likely have been patentable. This takes action consistent with his knowledge cal, biological, or physical, relies on hypothetical modification of Flook suggests of natural laws controlling the catalytic pro- natural laws. But, more to the point a narrower test; a mathematical algorithm cess. In Mayo, the doctor receives a number here is that claim 20 applies certain output in a must be a control and takes action consistent with his knowl- steps to transformed cells that, input to a machine or transformation of edge. Flook, Bilski and Mayo have one as has been pointed out above, are a matter. The Court, in effect, tells us that the thing in common that distinguishes them product of man, not of nature. The “machines or transformation” criteria was from Diehr. They relied on human inter- Court, in its evaluation of the Mayo a “symptom” of patentability but not the vention, i.e., mental steps, which by their method claims, found that the addi- “cause.” Machines (such as computers that very nature result in inconsistent results. tional steps of those claims were not calculate algorithms) produce consistent, Many decisions by the Federal Circuit also sufficient to “transform” the nature reproducible results. Perhaps a viable sub- follow this pattern, repeatable processes of the claims from mere expression of stitute for “machine or transformation,” or are found to be patentable.11 Other repeat- natural laws to patent-eligible subject at least another clue to be used in determin- able processes utilizing a computer have

INTELLECTUAL PROPERTY TODAY OCTOBER, 2013 29 been rejected for an independent concept; applied the rule established in Flook and 1392 (C.C.P.A 1973) which held that a method “use of the machine must impose mean- would have invalidated the patent since it claim could not have a mathematical equation as 12 15 the final step. ingful limits on the claim’s scope.” The lacked an inventive concept. Is it possible 4. Eibel Process Co. v. Minnesota & Ontario Paper machine (computer) “must play a signifi- for Diehr to stand as precedent and require Co., 261 U.S. 45 (1923). cant part in permitting the claimed method that a process patent have an inventive 5. Tilghman v. Proctor, 102 U.S. 707 (1880). to be performed.”13 Considered together, concept? 6. 306 U.S. 86. 7. 437 U.S. at 585. algorithms produce concrete reproducible 8 For example, , 545 F.3d 943, 957 results; algorithms can be solved by com- CONCLUSION (Fed. Cir. 2008); Bilski v. Kappos, 130 S. Ct. puters; processes utilizing algorithms may Methods that calculate new informa- 3218, 3230 (U.S. 2010); Mayo Collaborative be patentable if the process would fail with- Services v. Prometheus Laboratories, Inc., 132 S. tion from gathered information may be Ct. 1289, 1294 (2012); Classen Immunotherapies, out use of the algorithms, and of course the patentable subject matter where that new Inc. v. Biogen IDEC, 659 F.3d 1057, 1067 (Fed. invention is novel and nonobvious. But con- information is used to operate a machine Cir. 2011); Fort Properties, Inc. v. Am. Master sidering one of the opinion in CLS Bank, or transform matter. Methods that use Lease LLC, 671 F.3d 1317, 1321 (Fed. Cir. 2012). at what point does reproducible become information, gathered from man-made 9. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., conventional and obvious? materials, may also be patentable mate- 489 U.S. 141, 150-51 (1989). If requiring reproducible results, are rial. Diehr and Flook can be reconciled 10. Calculated by Flook and chemically analyzed by we potentially muddling the analysis? An Prometheus. by accepting that new information, calcu- 11. See State Street Bank & Trust v. Signature enabling disclosure is needed to com- lated from gathered information must be Financial Group, 149 F.3d 1368 (Fed Cir. 1998), ply with the first Paragraph of 35 U.S.C used to operate a machine or transform (patent eligible process was for calculating a share Section 112. Section 112 establishes that matter. In addition to the machine-or price would result in a repeatable result): In re the specification shall describe the inven- Comisky, 554 F.3d 967 (Fed. Cir. 2009) (pat- transformation clue, reproducibility of ent ineligible process for mandatory arbitration tion sufficiently to enable a person skilled the core objective of the patent could be resolution regarding unilateral and contractual in that art to make and use the invention. another useful clue. Reconciling Diehr documents; arbitration by its very nature is not But what if the invention is fully described with the inventive concept requirement reproducible); See CLS Bank Int’l v Alice Corp. but fails to produce consistent results? Is Pty., 2012 WL 2708400 (Fed. Cir. 2012) (pat- can only be accomplished by narrowing ent eligible process for exchanging obligations 16 this not a different question? Perhaps what Diehr to the specific case. A careful through third party results in consistent out- is missing from many patents rejected as review of the Syllabus section of the comes). non-patent eligible is a lack of repeatable Diehr decision reveals that the Court was 12. See Fort Properties, Inc. v. American Master or verifiable results that should result in a Lease, 671 F.3d 1317, 1323 (Fed. Cir. 2012) cit- focused on a process “performed upon ing Cyber Source Corp. v. Retail Decisions, Inc. §112 rejection. the subject-matter to be transformed and 654 F.3d 1366 (Fed. Cir. 2011), quoting In re reduced to a different state or thing.”17 Bilski 545 F.3d at 961. INVENTIVE CONCEPT Perhaps the Court, knowingly or not, has 13. SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010). Bilski did not add to our understanding reserved Diehr to cases involving trans- 14. But consider CLS Bank Int’l at *14 (minority concerning the characteristics of a pat- formation of matter. If such, the Court chastises the majority for failure to include an ent eligible process. In Mayo, the Court should restrain itself from using Diehr as inventive concept analysis as required by Mayo v. a guidepost for patentability of non-trans- Prometheus). returned to the requirement that “a process 15. The patent application filed by Diehr and Lutton, that focuses upon use of a natural law also formation of matter cases. Narrowing the however, teaches nothing about the chemistry of contain other elements or combination of reach of Diehr may result in simpler the synthetic rubber-curing process, nothing about elements” have an “inventive concept.”14 development of a separate rule to address the raw materials to be used in curing synthetic non-transformation-of-matter process rubber, nothing about the equipment to be used in 132 S.Ct. at 1294. The Court rejected the process, and nothing about the significance or the patent in Flook because it lacked an patents. IPT effect of any process variable such as temperature, inventive concept. 98 S.Ct. at 2528. Was curing time, particular compositions of material, there an inventive concept in Diehr? The ENDNOTES or mold configurations. In short, Diehr and Lutton do not claim to have discovered anything new majority of the Court fails to consider the 1. In re Bilski, 545 F.3d 943, 957 (Fed. Cir. 2008). 2. Bilski v. Kappos, 130 S. Ct. 3218, 3227 (2010). about the process for curing synthetic rubber. See question and instead focuses on the use 3. Prior to review by the Supreme Court, the United 450 U.S. at 205-06. of a well known equation in a process as a States Court of Customs and Patent Appeals 16. Alternatively, the Court could articulate the inven- whole, for the “transformation or reducing coined the term “post-solution activity” in the tive concept found in Diehr, potentially leading Application of Dale R. Flook, 559 F.2d 21 to clarity and continuity in the cases and related an article to a different state or thing.” 450 (C.C.P.A. 1977) to distinguish the case from the rules. U.S. at 192. The Diehr minority would have Application of Dean M. Christensen, 478 F.2d 17. 450 U.S. at 175-76.

30 INTELLECTUAL PROPERTY TODAY OCTOBER, 2013