Research and Study concerning Differences in Determination of Unity of among IP5 offices

The First International Affairs Committee Japan Intellectual Property Association

Abstract: In recent years, the offices of major countries have been actively working on harmonizing their patent systems. Since unity of invention is one of the key issues addressed through such transnational efforts, the First International Affairs Committee, one of the expert committees organized under the Japan Intellectual Property Association (JIPA), surveyed the situation of in some major countries. Our survey ascertained that the percentage of recognizing lack of unity of invention in the first action was exceptionally high in the United States. We would like to explain this peculiarity in US patent prosecution, and hope that this document will assist in the practical patent management of JIPA members. This document also introduces our suggestions for achieving patent system harmonization.

Table of Contents 5.3 Why Many Patent Applications in 1. Introduction the Field of Chemistry Are 2. Comparison of Statutory Provisions Rejected in the First Action Due to Concerning Unity of Invention Lack of Unity of Invention 3. Statistical Survey Concerning Unity 5.4 Coexistence of PCT Criteria and of Invention Examinations Non-PCT Criteria 3.1 Preconditions for the Survey 5.5 Other Conceivable Causes 3.2 Survey Results 6. Conclusion 4. Differences in Determination of Unity of Invention between 1. Introduction International Searching Authorities and National Patent Offices With the progress of globalization 5. Why Are Many Patent Applications of business, enterprises are becoming Rejected in the First Action on the increasingly willing to file patent Grounds of Lack of Unity of applications internationally for each Invention in the US? invention. The international 5.1 Differences in Judgment Criteria convergence of patent systems between the US and Other (including patent filing procedures and Countries the criteria for judging ) is 5.2 Differences in Practical Guidelines keenly awaited by industry; if it is for Judging STFs achieved, enterprises will be able to

1034 Intellectual Property Management Vol.65 No.8 2015 reduce filing costs and more accurately predict the possibility of successful 2. Comparison of Statutory patent registration. To keep up with this Provisions Concerning Unity of trend, the Five IP Offices (IP5), i.e., the Invention patent offices in Japan, the US, the EU, China, and Korea, have recently been Table 1 compares the provisions working on harmonizing their patent concerning unity of invention enforced systems. As part of such efforts, the IP5 in the respective countries (including a agreed in the Meeting of IP5 Heads of region and a treaty): Japan, the US, the Office held on June 6, 2014 that the IP5 EU, China, Korea, and the Patent would focus discussions on the three Cooperation Treaty (PCT). key issues for the harmonization of With regard to patent applications patent systems: written description and in the US (excluding those entering the sufficiency of disclosure, citation of phase of international application under , and unity of invention.1) In the the PCT), there is no concept of unity wake of this IP5 agreement, we of invention. However, the provisions conducted a fact-finding survey on concerning restriction and election of unity of invention, the theory of which species in the US patent laws are had not yet been supported by actual treated as the provisions concerning circumstances, in order to identify unity of invention for the purpose of differences among the IP5 patent comparison of the provisions adopted offices in terms of the assessment of by the respective countries. Therefore, unity of invention. Then, we examined in all subsequent descriptions in this some differing tendencies identified in document explaining patent prosecution the survey. in the US, the term “unity of invention” This document was written by the includes the concept of members of the Third Working Group restriction/election of species when it is of the FY2014 First International used in such expressions as “failure to Affairs Committee, consisting of: fulfill the unity of invention Ryota Fukumoto (Aisan Industry, requirement,” “non-compliance with serving as chairperson), Hajime the requirement of unity of invention,” Inamori (Sumitomo Chemical), Hideki “finding of lack of unity of invention,” Iwasaki (Ricoh), Daisuke Uchikawa or the like. (Seiko Epson), Daisuke Okamura (Panasonic Healthcare), Kenichi Kobiki Table 1: Comparison of Statutory Provisions (Mitsubishi Electric), Yoichi Hirata Concerning Unity of Invention

(Renesas Electronics), Chieko Fukuyama (Panasonic Healthcare), and Masayuki Tsutsumi (Nissan Motors, serving as vice chairperson).

1035 Intellectual Property Management Vol.65 No.8 2015 special technical feature (STF) making Underlying Essence of the referenced a contribution over the prior art. provision of the provision relevant law On the other hand, the US patent JP Article 37 of the If two or more have law says that independent and distinct common “special technical Article 25-8 of the features,” a group of those inventions lack unity of invention, Ordinance for inventions is determined to without considering whether there is an Enforcement of fulfill the requirement of unity STF or not (MPEP 806.02). the Patent Act of invention. US 35 U.S.C. 121 “Independent and distinct According to the first criterion that (US patent law) inventions” are determined to an examiner must satisfy to issue a lack unity of invention. 37 CFR 1.141 notice of the reasons for rejection on (US patent regulations) the grounds of lack of unity of EU Article 82 of the If a relates invention under MPEP 803, the European Patent to one invention only or to “a group of inventions so linked claimed inventions must be Convention (EPC) as to form a single general independent or distinct inventions. In Rule 44(1) of the inventive concept,” the Implementing requirement of unity of other words, the examiner need only Regulations of the invention is determined to be show either independence or Convention fulfilled. CH Article 31 of the Two or more inventions distinctness. While 35 U.S.C. 121 (US Patent Law embodied in a single general patent law) and 37 CFR 1.141 (US invention concept may be Rule 35 of the determined to fulfill the unity patent regulations) stipulate that Implementing of invention requirement. Regulations of the independent and distinct inventions are Patent Law determined to lack unity of invention, KR Article 45(1) of A group of inventions so the USPTO has been adopting a the Patent Act linked as to form a single general inventive concept may Article 6(1) of the practice of explaining either be claimed under one patent Enforcement application. independence or distinctness, not both, Decree of the in its examination procedure, in light of Patent Act PC Article 17(3)(a) of The requirement of unity of the development of legislation (MPEP T the PCT invention will be fulfilled only 802.01). The second criterion to Rule 13 of the when there is a technical determine lack of unity of invention Regulations under relationship among two or more inventions involving one the Patent under MPEP 803 is whether there or more of the same or Cooperation corresponding special would be a serious burden in the Treaty technical features. examination procedure, which is a seemingly abstract criterion. However, Looking into the provisions the guidelines described in MPEP concerning unity of invention enforced 808.02 expressly mention the three in the respective countries, Japan, the requirements to establish a serious EU, China, Korea, and the PCT adopt a burden: (A) separate classification, (B) common approach to judge unity of separate status in the art, or (C) invention, regardless of slight different field of search. Therefore, the differences in details. Their judgments examiner must demonstrate that the are based on whether or not there is a claimed inventions meet at least one of

1036 Intellectual Property Management Vol.65 No.8 2015 these three requirements. In practice, (US patent law) stipulates that the separate classification (pattern A) Director may cause the question of seems to be the most frequently used unity of invention to be reexamined reasoning to show a serious burden and under section 121, within the scope of issue a notice of the reasons for the requirements of the treaty and the rejection on the grounds of lack of Regulations, after the PCT application unity of invention. enters the US national phase. This Table 2 indicates the provisions provision means that unity of invention concerning examination of unity of may be reexamined in the US national invention in the laws and regulations of phase, regardless of whether lack of the respective countries which are unity of invention has been found or applicable to PCT applications entering not in the international phase. However, the national or regional phase. Japan such reexamination is supposed to be and Korea have no particular provisions limited to the scope of the requirements in this respect. Under the provisions of the treaty and the Regulations. This enforced in the EU and China, the means that the USPTO’s reexamination adequacy of a finding of of unity of invention must be based on non-compliance with the unity of the PCT criteria. invention requirement in the international phase is supposed to be Table 2: Provisions Concerning Examination of Unity of Invention for PCT Applications checked in order to determine whether Underlying Essence of the referenced or not to carry out the examination provision of the provision relevant law process for the claims for which an JP N/A N/A additional search fee was not paid in US 35 U.S.C. The Director may cause the 372(b)(2) (US question of unity of invention to the international phase. These patent law) be reexamined under section provisions correspond to Article 37 CFR 1.475, 121, within the scope of the 1.499 (US requirements of the treaty and 17(3)(b) of the PCT. In other words, patent the Regulations. applications directly filed with the regulations) EU Rule 164 of the If the examiner considers that national or regional Implementing the application documents do not Regulations of comply with the requirement of (“non-PCT applications”) also are the European unity of invention, the examiner controlled by the provisions equivalent Patent will inform the applicant that a Convention further search fee must be paid to the judgment criteria under the PCT within a period of two months, in Japan, the EU, China, and Korea. In and then the examiner will draw up the supplementary European these countries, therefore, there is search report for the parts of the substantially no difference between application relating to inventions in respect of which search fees PCT applications and non-PCT have been paid. applications when they are treated by the national patent or regional patent office. In contrast, 35 U.S.C. 372(b)(2)

1037 Intellectual Property Management Vol.65 No.8 2015 Underlying Essence of the referenced MPEP 803 If an examiner intends to require that an provision of the provision application be restricted to one of the relevant law claimed inventions, those plural CH Rule 115 of the If some parts of an international inventions must be patentably distinct Implementing application enter the Chinese inventions meeting the following Regulations of national phase without going criteria: the Patent Law through international search or (A) Those inventions must be international preliminary independent or distinct. examination and the applicant (B) There would be a serious burden on requests that such parts be the the examiner if restriction is not basis of examination, the required. competent office must give MPEP 808.02 In order to explain why there would be a notice to direct the applicant to serious burden on the examiner, the pay the restoration fee for unity examiner must show one of the of invention within the specified following: time limit. (A) Separate classification KR N/A N/A (B) Separate status in the art PC Article 17(3)(b) The national law of any (C) Different field of search T of the PCT designated state may stipulate 35 U.S.C. With regard to a PCT application, the (for that the relevant parts of the 372(b)(2) Director may cause the question of unity refe international application shall be (US patent law) of invention to be reexamined under renc considered withdrawn unless the section 121, within the scope of the e) applicant pays a special fee to requirements of the treaty and the the competent office of that Regulations. state. 37 CFR 1.475 When a group of inventions claimed in (US patent one PCT application forms a “single regulations) general inventive concept” and involves As a result of comparing the one or more STFs, this application is determined to fulfill the unity of provisions concerning unity of invention requirement. invention enforced in the respective countries, as explained above, the US 3. Statistical Survey Concerning applies its own judgment criteria to Unity of Invention Examinations non-PCT applications and the criteria compatible with those of Japan, the EU, For the purpose of grasping actual China, and Korea to PCT applications. examinations of unity of invention by Under the latter criteria, whether there the respective national patent offices, is an STF or not is checked to judge we gathered their patent prosecution unity of invention. For reference, the data and attempted to understand an provisions concerning unity of overall trend through a statistical invention in the US patent law are approach. excerpted in Table 3. 3.1 Preconditions for the Survey Table 3: Provisions Concerning Unity of Invention in the US Patent Law Underlying Essence of the referenced provision The application filings to be provision of the relevant law surveyed were chosen in accordance 35 U.S.C. 121 Independent and distinct inventions are with the following conditions. (US patent law) determined to lack unity of invention. 37 CFR 1.141 Two or more independent and distinct (US patent inventions may not be claimed in one (1) Countries surveyed regulations) national application. Patent application examinations in

1038 Intellectual Property Management Vol.65 No.8 2015 Japan, the US, the EU, and China were period from October 1, 2010 to surveyed. Korea was excluded from the December 31, 2010 and pending on survey described in this Section 3 since September 30, 2013 it was difficult to gather Korean file (iv) EU wrapper information. Patent applications for which an extended European search report and a (2) Time periods surveyed partial search report had been issued For the purpose of analyzing during the period from October 1, 2013 examination activities performed to December 31, 2013 during the same time span, we tried to (v) China set a specific time period. We initially Patent applications for which a intended to preferably choose patent request for examination had been filed applications for which the first action during the period from October 15, had been issued during the period from 2012 to January 15, 2013 and which October 1, 2013 to December 31, 2013. were pending on September 30, 2013 In reality, however, we could not use the same conditions for choosing data (3) Classification of inventions and from all the surveyed countries because numbers of surveyed applications of restrictions arising from the The patent applications meeting the functionality of their respective conditions described above were databases. Alternatively, we chose chosen at random in accordance with patent applications under the conditions the following classification: described below, which were determined in light of the average first I. Electrical engineering 500 action period of each country. Due to II. Instruments 500 the same restriction, US applications III. Chemistry 500 IV. Mechanical engineering 500 were chosen separately from non-PCT (applications in each country) applications and PCT applications. (i) Japan The identification of these areas Patent applications for which the complies with the technology first action was issued during the period classification specified in the IPC and from October 1, 2013 to December 31, Technology Concordance Table, which 2013 has been prepared based on the (ii) US (non-PCT applications) International Patent Classification Patent applications filed during the (IPC) established by the World period from April 1, 2012 to June 30, Intellectual Property Organization 2012 and pending on September 30, (WIPO). 2013 (iii) US (PCT applications) (4) Survey content and judgment Patent applications filed during the criteria

1039 Intellectual Property Management Vol.65 No.8 2015 We reviewed the patent the same category” (Rule 43(2) of the applications chosen in the way Implementing Regulations of the described above, in order to check European Patent Convention). whether or not a judgment about unity of invention had been exhibited in the Table 4: Survey Results by Country and by Category first action. Then, we analyzed Electrical Mechanical Chemistry Instruments differences by country and by category engineering engineering JP 3% 2% 5% 1% (technology area) through comparing US the percentages of applications facing (non- 53% 15% 28% 28% such judgment. PCT) US (PCT 58% 15% 29% 28% 3.2 Survey Results ) 9% 7% 9% 4% EU Table 4 and Figure 1 indicate the (1%) (1%) (1%) (1%) CH 4% 1% 1% 2% percentages of patent applications Note:The parenthesized figures for the EU are the resulting in a finding of lack of unity of percentage of applications causing a violation of Article 43(2) of the Implementing Regulations of the EPC. invention by category and by country. Our comparison by country discovered Figure 1: Survey Results by Country and by that the US had an extremely high Category (graph) percentage of applications resulting in a finding of lack of unity of invention in Chemistry Electrical engineering each of the specified categories. We also found that both PCT applications Instruments Mechanical and non-PCT applications in the US engineering showed almost the same percentage resulting in a finding of lack of unity of invention. Looking into the percentages by category, the area of chemistry showed a high percentage in each country. Japan US US EU China (non-PCT) (PCT) Among others, in the US over 50% of applications resulted in a finding of lack of unity of invention, which is a 4. Differences in Determination of noteworthy figure. Unity of Invention between The figures for the EU include International Searching patent applications involving Authorities and National Patent non-compliance with the unity of Offices invention requirement, as well as patent applications failing to comply with the Section 3 explains the result of the principle of “one independent claim in statistical survey concerning

1040 Intellectual Property Management Vol.65 No.8 2015 examinations of unity of invention by judgments about unity of invention the respective national or regional generally match each other in the ISA’s patent offices. Section 4 analyzes examinations and each national office’s differences in determination of unity of examinations. invention by those patent offices in On the other hand, the USPTO greater depth. For this analysis, we issued a notice of the reasons for would like to explain the result of rejection for 19 applications (18%) on surveying 108 patent families covered the grounds of lack of unity of by PCT applications filed from 2005 to invention as a result of its own 2007 (extended to Japan, the US, the examinations, even though their ISR EU, China, or Korea), in order to had not recognized lack of unity of understand differences between the invention. Compared with other judgments about unity of invention by countries, the US had a tendency to International Searching Authorities render judgments about unity of (ISA) in the PCT phase and the invention differing from ISA’s judgments made after entry into the judgments. national phase in respective countries. The most typical reason for Since our survey was focused mainly determining non-compliance with the on applications filed by Japanese unity of invention requirement and enterprises, the PCT applications issuing a notice of the reasons for surveyed were chosen from those rejection in the US is described as examined by the Japan Patent Office follows: independent claims falling acting as the ISA. The file wrapper under separate categories (e.g., a claim information of the patent families for products and a claim for a surveyed was obtained from the First manufacturing method) do not involve Patent Committee of JIPA. any common STF based on citation of Regarding the applications prior art documents (11 of 19 examined in the countries other than applications). Among those the US (Japan, the EU, China, and applications, given below are the case Korea), there was no international examples wherein the ISA and the search report (ISR) identifying lack of USPTO made different judgments unity of invention. After entry into the about unity of invention. national phase in each country, the applications receiving a notice of the (1) Case where the USPTO judged reasons for rejection on the grounds of that there was no STF by citing prior lack of unity of invention were as art documents determined to fall follows: one application (1%) in Japan, under Category “Y” in an ISR nine applications (8%) in the EU, four Regarding an international applications (4%) in China, and three application containing independent applications (3%) in Korea. Thus, claims falling under separate categories

1041 Intellectual Property Management Vol.65 No.8 2015 (International Application Number: (3) Case where no prior art PCT/JP2006/319573), the ISR documents were indicated determined that the cited documents Regarding an international were classified into Category “Y” (a application containing independent category for documents to be cited to claims falling under separate categories deny inventive step) and there was no (International Application Number: mention of lack of unity of invention. PCT/JP2006/310780), the ISR However, in the process of the determined that the prior art documents examination of a US application after were classified into Category “A” entry into the US national phase (documents showing a technical (Application Number: 11/992646), the background that can be used only for examiner determined that there was no reference) and there was no mention of STF by using the same documents as lack of unity of invention. However, a those cited in the ISR and issued a notice of the reasons for rejection was notice of the reasons for rejection on issued for a US application after the grounds of lack of unity of entering the national phase invention in accordance with Rule 13 (Application Number: 11/914843) on of the PCT Regulations. the grounds of lack of unity of invention, without indicating any prior (2) Case where unity of invention art documents, while reference to Rule was judged based on non-PCT 13 of the PCT Regulations was made. criteria In this decision, each of the After an international application independent claims was determined to (International Application Number: be independent or distinct and to fall PCT/JP2006/319572) entered the US within a separate technology area and national phase and was identified as a the examiner demonstrated a serious US application (Application Number: burden by insisting on the necessity of 12/ 067996), this US application searching in different fields, etc. In fact, received a notice of the reasons for the examiner relied on the criteria for rejection, without indication of any non-PCT applications in this case. prior art documents and the applicable provision of the PCT Regulations. The 5. Why Are Many Patent applicant was informed that the claim Applications Rejected in the First for products and a manufacturing Action on the Grounds of Lack of method should be divided to fulfill the Unity of Invention in the US? unity of invention requirement based on MPEP 806.05, while this provision As explained in Section 3, the US refers to the criteria for non-PCT has a higher percentage of issuing a applications. notice of the reasons for rejection on the grounds of non-compliance with the

1042 Intellectual Property Management Vol.65 No.8 2015 unity of invention requirement than the criteria for judging unity of invention other countries. In this Section 5, we for non-PCT applications in the US consider the causes of such tendency deviate significantly from the judgment based on a comparison of the statutory criteria adopted in the other countries. provisions explained in Section 2 and We therefore consider that such the survey results described in Section difference in the judgment criteria 4. The conceivable causes that we constitutes one of the causes of a high inferred are listed as follows. percentage of issuing a notice of the reasons for rejection due to lack of (i) Compared with the criteria enforced unity of invention in the US. in the other countries, issuing a As noted before, patent applications notice of the reasons for rejection is are to be rejected due to easier under the US criteria. non-compliance with the unity of (ii) Since judgments about STFs in the invention requirement under MPEP 803 US differ from those in the other when the claimed inventions are countries or under the PCT, notices determined to be “independent or of the reasons for rejection due to distinct” and expected to cause a lack of unity of invention in the US “serious burden” on the examiner. We outnumber those in other countries. take a look at these two viewpoints (iii) Since the US maintains criteria based on differences in judgment different between PCT applications criteria between the US and the other and non-PCT applications, US countries. examiners are apt to mistakenly issue a notice of the reasons for rejection. (1) Being independent or distinct (iv) Other This viewpoint refers to the Section 5 provides detailed assessment to judge whether the explanations about these conceivable claimed inventions are independent or causes. As shown in Section 3, the distinct. Under MPEP 802.01, the term US has a particularly high percentage “independent” means that there is no of applications resulting in a finding disclosed relationship between the two of lack of unity of invention in the or more inventions claimed. area of chemistry. The causes of this Understandably, there is no STF among situation also are considered in two or more independent inventions. If Section 5. such independent inventions are claimed in one application, no 5.1 Differences in Judgment significant difference will arise in Criteria between the US and judgments about unity of invention Other Countries between the US and the other countries. In the meantime, judging whether As described in Section 2, the “distinct” or not seems to be based on

1043 Intellectual Property Management Vol.65 No.8 2015 different ideas and criteria, while both inventions of products and a the US and the other countries focus on manufacturing method in one the relationship between the claimed application are considered to be inventions in some way. independent or distinct under the US The countries other than the US criteria. judge unity of invention based on STFs, In this way, the claimed inventions as explained in Section 2; if the claims examined under the US criteria are falling under separate categories are more likely to be recognized as being determined to be related, they are to be independent or distinct, compared with treated as a single invention in the the assessment in the other countries. examination procedure in those countries. In contrast, the scope of (2) Serious burden inventions determined to be “distinct” This viewpoint refers to the is broader under the US criteria, assessment to judge whether or not whereby the claims falling under there would be a “serious burden” in separate categories are readily the examination process. No similar recognized as being distinct. judgment criteria are established in the Let us take an application claiming countries other than the US. This rule products and a manufacturing method seems to allow US examiners to easily as an example. In the countries other demonstrate that there would be a than the US, if the claimed serious burden. Below are the reasons manufacturing method is determined for such inference. appropriate for the manufacture of the As explained in Section 2, MPEP claimed products, those manufacturing 808.02 provides guidelines for applying method and products will be this rule. If multiple claims in one determined to be related to each other application involve different patent and unity of invention will be categories (separate classification), acknowledged. In the US, if the separate technology areas (separate invention claimed for the products can status in the art), or different scopes of be manufactured by any method other prior art search (separate field of the claimed manufacturing method, the search), they are considered to cause a claimed products and manufacturing serious burden on the examiner. method will be determined to be If the claimed inventions fall under distinct based on the patterns of different categories, they will be readily “related invention” listed in MPEP recognized as being distinct, as 806.05 (MPEP 806.05(f)). In reality, a explained in (1) above. In this event, situation where the claimed the requirements for demonstrating a manufacturing method is the only way serious burden also will be readily to manufacture the claimed products is satisfied. For example, even when a very rare. In most cases, therefore, the claim for products and a claim for a

1044 Intellectual Property Management Vol.65 No.8 2015 manufacturing method are closely criteria and abolish the criteria allowing related to each other, these claims are, for subjective and discretionary in general, to be classified into separate operation by examiners. We have patent categories. Therefore, the already proposed this reform in examiner has only to show separate conferences discussing patent system classification, and then the requirement harmonization and on other occasions, for a serious burden can be readily and the proposal has gained some satisfied. support by associations organized by With regard to at least the “separate patent applicants or owners, among field of search” requirement, it is others. The First International Affairs considered possible to insist on the Committee will continue to advocate necessity to examine a different scope this proposal on appropriate occasions. of search merely because one With the full-scale launch of the application involves separate claims. Cooperative Patent Classification This means that a “separate field of (CPC) system in the US from FY2015, search” is applicable based on each the patent classification used to examiner’s subjectivity. In other words, establish a serious burden has been if the examiner judges that there would shifted from the United States Patent be some burden in examination, the Classification (USPC) to the CPC examiner can conclude that it would be system. We are observing how this a serious burden. In this way, it is easy changeover will affect the percentage for examiners to apply the serious of issuing a notice of the reasons for burden criterion. rejection on the grounds of lack of Owing to these criteria which are unity of invention in the US. readily applicable based on either “independent or distinct” or “serious 5.2 Differences in Practical burden,” patent applications examined Guidelines for Judging STFs in the US are apt to be rejected in the first action on the grounds of As described before, US non-compliance with the unity of applications filed through the PCT invention requirement. route are supposed to undergo a process If these judgment criteria peculiar of judging unity of invention based on to the US impose a heavier burden on the PCT criteria in principle, namely, applicants in the US national phase based on the criteria for judging STFs, alone, such criteria must be corrected before commencement of substantive for the sake of patent system examination at the USPTO. Since some harmonization. As with the other applications may be rejected on the countries, the US should introduce the grounds of non-compliance with the assessment of unity of invention based unity of invention requirement in this on STFs in conformity with the PCT process, the number of applications to

1045 Intellectual Property Management Vol.65 No.8 2015 be covered by substantive examination multiple independent claims, but at can be reduced in advance. To enforce least one of those claims was this operation, the examiner is required determined to lack in their ISR. to demonstrate that there is no STF for It is therefore not surprising that even the inventions claimed in the though the ISR had stated that there application being examined. was no STF, the judgment made in the The practical procedure by US national phase is considered to examiners starts with the assessment of match the PCT criteria in this respect. an STF or STFs in the claims in With regard to the four applications comparison with the prior art mentioned above, the notice of the mentioned in the International Search reasons for rejection based on lack of Report (ISR). Since the criteria for unity of invention describes the reasons judging STFs are strict in the US, we for judging that there was no STF. In inferred that such strict criteria this sense, the US examination of each contributed to a high percentage of of those four applications is considered rejection notices on the grounds of lack to match the PCT criteria. In summary, of unity of invention in the US. while judgments about STFs in the US The survey as described in Section meet the PCT criteria in general, the 4 discovered 16 PCT applications practical guidelines for making such resulting in a finding of lack of unity of judgments in the US are more stringent invention in the US national phase than those in the other countries. This is whereas their ISR had not recognized considered to raise the percentage of lack of unity of invention. As a result of issuing a notice of the reasons for scrutinizing these 16 applications, we rejection due to lack of unity of found that three of them had received a invention in the US. While such notices notice of the reasons for rejection on state the reasons for judging that there the grounds of lack of unity of was no STF, we discovered that those invention, based on the citation of the statements are detailed in some cases documents classified into Category “X” and simplified in other cases. To (a category for documents to be cited to ascertain whether the reasons for such deny novelty) in their ISR to judgments are sufficiently explained or demonstrate that there was no STF. We not, we are going to continue our also found that four of the 16 observations and considerations in this applications had received a notice of respect. the reasons for rejection on the grounds We need to encourage efforts for of lack of unity of invention, based on patent system harmonization in terms the citation of the documents classified of judgments about STFs in the US. At into Category “Y” to demonstrate that the same time, however, we would like there was no STF. Each of the three to remind applicants of the high applications first mentioned contained likelihood of receiving a notice of the

1046 Intellectual Property Management Vol.65 No.8 2015 reasons for rejection on the grounds of invention relies on these provisions lack of unity of invention in the US probably because applications filed in when documents falling under the area of chemistry are usually Category X or Category Y are cited in drafted in such a form to claim a new the ISR. With this in mind, applicants substance as the first invention and to are recommended to consider claim a method for synthesizing or submitting a preliminary amendment in using this new substance or a advance to modify a claim composition of matter formed by appropriately according to mixing the new substance and other circumstances. ingredients as the second and subsequent inventions. Such 5.3 Why Many Patent composition of claims is apt to receive Applications in the Field of a judgment acknowledging unity of Chemistry Are Rejected in the invention in the surveyed countries First Action Due to Lack of Unity other than the US. On the contrary, the of Invention US tends to determine that such claims are “independent or distinct” and would As explained in Section 3, the potentially cause a “serious burden.” percentage of applications resulting in a finding of lack of unity of invention (2) Restriction requirement ratios by (i.e., the restriction requirement ratio in art unit the US) is remarkably high in the area Subsequently, our analysis focused of chemistry. In this subsection, we on examinations in the area of look into characteristics identified in chemistry by the respective units of the patent applications in the area of USPTO. The area of chemistry is chemistry. broadly divided into the chemical field and the medical and pharmaceutical (1) Composition of claims field. We reviewed the file wrappers for As a result of analyzing types of each of the patent families chosen, restriction, frequently used reasons for constituting 108 applications in total. requiring restriction are listed as These 108 applications include 12 follows in descending order: MPEP applications in the chemical field and 806.05(h) (Product and Process of 11 applications in the medical and Using) accounted for 62%, MPEP pharmaceutical field, for which a notice 806.05(j) (Related Products; Related of the reasons for rejection was issued Processes) for 35%, and MPEP 806.06 on the grounds of lack of unity of (Independent Inventions) for 15%. Two invention in the US. The units in charge or more types of the foregoing were of the examinations of those mentioned at the same time in some applications in the USPTO are as cases. A finding of lack of unity of follows: five applications in the

1047 Intellectual Property Management Vol.65 No.8 2015 chemical field and 11 applications in resulting in the USPTO’s finding of the medical and pharmaceutical field by lack of unity of invention while the ISR Art Unit 1600 (Biotechnology and acknowledged unity of invention in the Organic Chemistry), and seven PCT phase. applications in the chemical field and Why does the medical and zero in the medical and pharmaceutical pharmaceutical field show a field by Art Unit 1700 (Chemical and remarkably high restriction requirement Materials Engineering). In general, it ratio in the area of chemistry? We seems that Art Unit 1600 is responsible presume that this situation depends on for examinations in the medical and whether inventions of diagnostic or pharmaceutical field and that Art Unit therapeutic methods are claimed or not, 1700 is responsible for examinations in since diagnostic and therapeutic the chemical field. methods are not eligible for patent According to “PATENTLYO,” a protection in the countries other than website launched on June 15, 2010 to the US. In other words, such a situation offer information on published patent is considered to be caused by the applications that have been disposed of difference in the scope of patentable (http: inventions. //patentlyo.com/patent/2010/06/likeliho Two of the seven surveyed patent od-of-office-action-rejections.html), the families in the medical and restriction requirement ratio is 54% in pharmaceutical field received a notice Art Unit 1600 and 21% in Art Unit of the reasons for rejection due to lack 1700. In other words, a higher of unity of invention recognized in restriction requirement ratio is found in connection with diagnostic or the chemical field than in the medical therapeutic methods. The rejection and pharmaceutical field. notice for each of those two patent families refers separately to the claimed (3) Characteristics in the medical invention for products and the claimed and pharmaceutical field invention for a diagnostic or therapeutic Of the 108 patent families reviewed method using the products. as described in Section 3, we International Application Number scrutinized the patent families PCT/JP2006/311073 (US Application classified in the medical and Number: 11/916356) mentioned before pharmaceutical field. The applications is considered in more detail below. In scrutinized here are seven patent the examination process in the US, the families filed through the PCT route claimed invention for the products was and subsequently entering the US determined to lack novelty based on national phase, involving the same cited references which had not been compositions of claims in the PCT mentioned in the ISR. As a result, the phase and the US national phase, and claimed invention for a diagnostic or

1048 Intellectual Property Management Vol.65 No.8 2015 therapeutic method in a separate The area of chemistry as a whole category was determined to lack unity tends to show a high restriction of invention on the grounds that there requirement ratio, especially in the was no STF. Looking at the patent medical and pharmaceutical field. application bearing the International Since our survey this time covers Application Number of only a limited number of patent PCT/JP2006/319912 (US Application applications, we are going to continue Number: 11/992817), a therapeutic to observe and consider this issue. (preventive) drug was claimed in the PCT phase and the subject matter of the 5.4 Coexistence of PCT Criteria claim was changed to a therapeutic and Non-PCT Criteria (preventive) method when entering the US national phase. However, this As explained in the preceding application was determined to fail to sections, the US adopts separate criteria fall under any of the specified for PCT applications and for non-PCT categories (37 CFR 1.475) and resulted applications to judge unity of invention. in a finding of lack of unity of US examiners are therefore forced to invention in the US examination, use different criteria according to the without citing any references. filing route, even though their judgment While the propriety of a judgment is made for the same claim within the by a US examiner can be controversial, same nation. This may sometimes lead this is a problem peculiar to the medical to their misunderstanding or confusion and pharmaceutical field. Diagnostic or when adopting the judgment criteria, therapeutic methods are not eligible for and some applications may mistakenly patent protection in the countries other result in a finding of lack of unity of than the US. If a claim contains an invention which should otherwise be invention for a diagnostic or therapeutic avoided. method when entering the US national As a result of analyzing the details phase, US examiners seem to have a of 16 applications resulting in a finding tendency to recognize lack of unity of of unity of invention, we found that two invention. Therefore, the difference in of them were examined and judged the scope of patent protection between under the non-PCT criteria while they the US and the other countries is should have been controlled by the presumed to be a major factor leading PCT criteria. to a high restriction requirement ratio in While we cannot conclude at the medical and pharmaceutical field present that such situations raise the than in other fields in the area of percentage of recognizing lack of unity chemistry. of invention in the US, erroneous judgments are never acceptable to (4) Summary of Subsection 5.4 applicants. If an applicant faces such

1049 Intellectual Property Management Vol.65 No.8 2015 misjudgments, it would be worth species, resulting in the election of the considering traversing the examiner’s claim corresponding to the elected decision or action. embodiment. Determination of unity of Needless to say, patent systems invention in the countries other than the must be properly operated in such a US is a process of assessing unity of way as not to cause incorrect judgments. invention between the claims in one More importantly, however, such application, which resembles the misjudgments as explained here would concept of restriction between the never occur if the PCT criteria alone claims in the US. However, there is no were used as the standard for assessing concept equivalent to election of unity of invention. We therefore intend species in the assessment of unity of to advocate proper operation of patent invention in the countries other than the systems, as well as integrated adoption US. After the applicant elects one of the PCT criteria as the standard for species in response to an election of judging unity of invention. species recruitment, its claim may eventually be accepted as one 5.5 Other Conceivable Causes application if the generic claim withdrawn is considered. If, however, As illustrated in Section 2, this the claim is determined not to cover document is based on the assumption one species, the applicant will need to that the concept of a “finding of lack of divide the application. The burden on unity of invention” when used with the applicant in this event is similar to reference to the US includes a the burden in case of a restriction requirement for restriction or election requirement. This is why we consider of species. The provisions concerning a that an election of species requirement restriction requirement refer to unity of is similar to a finding of invention between the claimed species, non-compliance with the unity of which is intended to require the invention requirement. applicant to elect a single group According to our survey, the (species). On the other hand, an percentage of rejection notices due to election of species requirement is lack of unity of invention involving an related to a patent application for a election of species requirement only single generic claim covering multiple was 14% in the area of chemistry, 6% species and this is intended to require in the area of electrical engineering, the applicant to elect a species when 12% in the area of instruments, and such a generic claim is not patentable. 10% in the area of mechanical Since each species corresponds to a engineering. These figures show that specific embodiment in general, the the concept of election of species applicant usually elects one contributes to raising the total embodiment accompanied by one percentage of issuing a notice of the

1050 Intellectual Property Management Vol.65 No.8 2015 reasons for rejection due to lack of applications as possible. Therefore, it is unity of invention in the US. highly likely that US examiners are Another conceivable factor eager to issue a rejection notice based contributing to such a high ratio of on non-compliance with the unity of rejection notices is the trend toward invention requirement. timely patent prosecution in the US. The USPTO is promoting a strategy to 6. Conclusion achieve timely examination with specified goals. When former Director In this survey, we compared major David J. Kappos took office in the countries’ systems concerning unity of USPTO, the 2010-2015 Strategic Plan invention and investigated trends in was established to enhance patent their judgments in patent prosecution. quality and timeliness. Under this plan, The survey showed that the US is examiners were encouraged to identify peculiar in terms of the unity of patentable subject matter early and invention scheme, as well as in terms of strive for “compact prosecution” to the percentage of issuing a notice of the optimize patent pendency.2) This plan reasons for rejection on the grounds of set out the target time periods for patent lack of unity of invention. With a focus prosecution practices to be followed by on the US, which has a particularly each examiner for each application. high percentage of rejection notices in Such targets require examiners to the first action, we considered its complete the whole process from reasons and identified the key points in search through examination to first light of patent system harmonization. within this time constraint. Regarding non-PCT applications in US examiners therefore seem to prefer the US, we ascertained that they tend to to narrow the scope of examination face a notice of the reasons for rejection with the intention of reducing the time due to lack of unity of invention spent for reviewing each application. primarily because the US examination Furthermore, there are some criteria are prone to such judgments. opinions that the USPTO’s patent Regarding PCT applications in the US, examiner count system, i.e., the US statutory provisions concerning performance evaluation system for unity of invention conform to the PCT examiners, contributes to a high criteria, as is the case with other major percentage of rejection notices on the countries. Nevertheless, we found a grounds of lack of unity of invention. It strong tendency of willingly issuing a is a fact that examiners are supposed to notice of the reasons for rejection on be granted reward points according to the grounds of lack of unity of the number of applications processed, invention, while conforming to the and this reward point system may PCT-compatible criteria. motivate examiners to process as many When asking the US to harmonize

1051 Intellectual Property Management Vol.65 No.8 2015 the patent system in terms of unity of Notes: invention, it is not enough to call for 1)“Results of the Seventh Meeting of alignment with the other countries’ the IP5 Heads of Office Held in criteria, but it is also important to ask Busan, ROK,” News Release dated for harmonization in terms of operation June 6, 2014 (published in English of the criteria in parallel. on April 18, 2014) From the standpoint of applicants, http://www.meti.go.jp/english/press/i the decision to issue a notice of the ndex.html (accessed and confirmed reasons for rejection due to lack of in 2016) unity of invention in the US national 2)「米国特許商標庁の改革に伴う審 phase appears to have been somewhat 査環境の変化とそれに対応した実 unsatisfactory, but many of those 務 ｣ ( 知 財 管 理 (IP Management) applicants may not have bothered to Vol. 61, No. 8, 2011) object. Going forward, however, we recommend applicants to raise (Manuscript received on March 30, objections when the examiner’s 2015) decision does not meet the criteria, recognizing the judgment criteria in the US and their peculiarity. We expect that such responses by applicants will help improve the level of individual examiners in the US. If their examination quality is improved, the number of applications that are easily rejected on the grounds of lack of unity of invention is expected to be reduced, which will surely be advantageous for applicants. We hope the survey outlined in this document will help promote the harmonization of patent systems among the IP5 nations in terms of determination of unity of invention, and help JIPA members develop an understanding of the criteria concerning unity of invention of the IP5 nations.

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