CTNF 18/704,814 CTNF 83498 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority This application is a 371 of PCT/EP2022/079807 (10/25/2022) and claims foreign priority to INDIA 202111048682 (10/25/2021). Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. Claims 16-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 16 and 17 use the language “preferably” which renders the claims indefinite. MPEP 2173.05(c). Claim Rejections - 35 USC § 112(a) 07-30-01 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. 07-31-02 Claims 1-3, 5, 7-10, 12-16, 19-21 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The scope of enablement provided in the disclosure is not commensurate in scope with the claims when considering the factors detailed in MPEP 2164.08: The courts have repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’” or that any experimentation must be “reasonable”. See Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023); McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 2020 USPQ2d 10550 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 107 USPQ2d 1273 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 2019 USPQ2d 415844 (Fed. Cir. 2019). See also In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). … With respect to the breadth of a claim, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. The Federal Circuit, citing McRO, provided guidance on the application of enablement to genus claims, holding that “[a]lthough a specification does not need to describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range.” Sanofi-Aventisub, 987 F.3d at 1085 (internal quotations omitted). AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In reMoore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention irrelevant to enablement determination). Claim 1 is to a “compound of formula (I)” with X1, G, R2, R7, and Q variable elements, for example, some of which include substituents such as substituted heteroaromatic systems. The instant disclosure does not contain sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention upon consideration of the factors set forth in In re Wands , 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), as follows. See also MPEP § 2164.01(a) and § 2164.04. The breadth of the claims – the claims are to a compound of formula (I) which is a large genus of compounds having in excess of billions of compounds. The state of the prior art – the specification does not describe a clear mechanism of action, however, pesticidal compounds have been shown to drastically change from inactive in activity upon small changes in structure such as the addition of a methyl group (i.e., US9439427, col. 50-64). The level of one of ordinary skill – the level of skill in the art is high as evidenced by US9439427. The level of predictability in the art – the art is highly unpredictable due to the complex nature of the mode of action of the compounds used. The particular art is also unpredictable because there is no known or demonstration of how the compounds produce an effect that would be effective. Furthermore, as evidenced US9439427 small changes in inhibitor structure can cause drastic changes in pesticidal efficacy. The amount of direction provided by the inventor – the primary guidance provided regarding the utility of the compounds and their ability to act as a pesticide or plant protection is of the biological examples on pages 116-118 wherein a small number of highly similar compounds were tested for activity. The chemical space of the compounds tested is extremely narrow when compared to the full scope of the claims. In addition, there is no guidance regarding how the alleged use would reasonably correlate with the entire scope of that claim based on the structure of the compounds of those tested – the capability to recognize or understand the structure from the mere recitation of function and minimal structure space is highly unlikely. This lack of supporting data and explanation would cause one of skill in the art to question whether the examples support the enablement of the full scope of the claims beyond those demonstrated to be useful – i.e., the following tested compounds P 2-5, 7-11, 13-16 Formula I PNG media_image1.png 131 199 media_image1.png Greyscale Q: PNG media_image2.png 175 346 media_image2.png Greyscale wherein, the tested compounds correspond to “X1” is N; “G” O N(1 example); “R7” is H, CH3(2 examples); “R2” CF3, OCHF2 (1), OCF3 (1); and “Q” (having groups XR1, R3, Q1): “XR1” has SO2Et, Set; “R3” has H; “Q1” has H, CpCN, 2-MePrCN, O-MePrCN, Br, Cp, 4-F-Ph. The existence of working examples – the examples described above were singularly tested in plants against common pests citing 200ppm application and at least 80% mortality without granular detail as to efficacy. The quantity of experimentation needed to make or use the invention based on the content of the disclosure – given the high level of unpredictability in the art, the lack of a significant chemical space of working examples, and the limited guidance provided in the examples, there would be a tremendous amount of experimentation required before one of skill in the art could practice the claimed invention including the asserted utility. In view of the specification and evidence of record, one of skill in the art would be required to perform an undue amount of experimentation to test each of the compounds of the claims including synthesizing the compounds, using additional appropriate models, select candidates for further development, perform testing to determine dosing, and finally efficacy testing. Thus, one of skill in the art would be required to start ab initio without any expectation of success and develop any other compound within the scope of the claims. Such a level of experimentation is undue. Weighing the above factors by a preponderance of the evidence results in the conclusion that the claims are not enabled for the full scope of Formula (I) beyond a genus of compounds predictably expected to show activity based on those shown to have activity. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-35 Claim s 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 19124741 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application to the same utility claims a positional isomer (P1) of the instant claim P4 – differing by the position of the trifluoromethyl. MPEP 2144.09 (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 -CH 2 - groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)) . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626 Application/Control Number: 18/704,814 Page 2 Art Unit: 1626 Application/Control Number: 18/704,814 Page 3 Art Unit: 1626 Application/Control Number: 18/704,814 Page 4 Art Unit: 1626 Application/Control Number: 18/704,814 Page 5 Art Unit: 1626
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