SARS-COV-2 INHIBITORS FOR TREATING CORONAVIRUS INFECTIONS

§103 §DOUBLEPATENT

DETAILED ACTION All rejections and objections not listed below have been withdrawn. Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. PCTCN2021128243, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated a lack of support for the compounds: from the second row of compounds on instant claim page 24 through page 27. These compounds lacked support in the priority document PCTCN2021128243. Thus claim 49 received a priority date of 09/05/2022. The rest of the claims received a priority date of 11/02/2021. Claim Rejections - 35 USC § 103- Updated due to Amendment In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51, 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZAVORONKOVS (ZAVORONKOVS et al., WO 2021219089 A1, publication date 2021-11-04, effective filing date 2020-04-30, IDS). The reference ZAVORONKOVS teaches the following general formula [006] for the purpose of treating coronavirus infection(title). PNG media_image1.png 260 740 media_image1.png Greyscale PNG media_image2.png 32 311 media_image2.png Greyscale PNG media_image3.png 133 589 media_image3.png Greyscale PNG media_image4.png 47 673 media_image4.png Greyscale The reference ZAVORONKOVS teaches that in some embodiments R5 is methyl[0078]. PNG media_image5.png 114 319 media_image5.png Greyscale ZAVORONKOVS teaches this lead compound (above)(page 78). This is nearly the same as the instant compound on page 25(below) of the instant claims expect for the methyl group at R5 and the rotation of the 5-membered ring. The reference teaches R11 of the general formula as being thiazole without a specific orientation[0098]. PNG media_image6.png 192 314 media_image6.png Greyscale This helps to teach claims 1, 5, 6, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49, 51, 63. The reference ZAVORONKOVS teaches(reference claim 67): PNG media_image7.png 61 643 media_image7.png Greyscale This helps to teach claim 50. The reference ZAVORONKOVS does not teach a specific compound of instant claim 49 but instant requires picking and choosing several variables, the same is true for claims all claims. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified ZAVORONKOVS to achieve a compound of the instant invention because all necessary changes are suggested by embodiments under the general formula of the reference. For instance, the instant compound shown above only requires two changes to be made from the lead compound on reference page 78; an addition of a methyl which is suggested by paragraph [0078] and the rotation of the 5-membered ring suggested by page [0098]. One would be motivated to do so since the compound of the general formula of the reference are suggested for treating coronavirus infection and such slight modifications may keep the same overall activity but improve performance. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). One would have a reasonable expectation of success because these changes are suggested by the reference. The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Double Patenting- Updated due to Amendment 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. Claims 1, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51, 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11731944 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because: The patent ‘944 claims: PNG media_image8.png 258 300 media_image8.png Greyscale PNG media_image9.png 542 249 media_image9.png Greyscale PNG media_image10.png 853 577 media_image10.png Greyscale PNG media_image11.png 839 565 media_image11.png Greyscale PNG media_image12.png 844 592 media_image12.png Greyscale PNG media_image13.png 874 576 media_image13.png Greyscale PNG media_image14.png 854 595 media_image14.png Greyscale PNG media_image15.png 857 667 media_image15.png Greyscale PNG media_image16.png 788 618 media_image16.png Greyscale This anticipates claims 1, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51, 63. Claims 1, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51, 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of copending Application No. 19/522,024 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because: The application ‘024 claims: PNG media_image17.png 430 777 media_image17.png Greyscale PNG media_image18.png 562 655 media_image18.png Greyscale This anticipates claims 1, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51, 63. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Arguments Applicant's arguments filed 09/16/2026 have been fully considered but they are not persuasive. U.S.C. 103 Rejection The applicant argues that the reference ZAVORONKOVS does not qualify as prior art under 102(a)(1) because the publication of ZAVORONKOVS was after the priority date of the instant invention. However, this is not persuasive for claim 49 because a claim by claim analysis indicated a lack of support for the compounds: from the second row of compounds on instant claim page 24 through page 27. These compounds lacked support in the priority document PCTCN2021128243. Thus claim 49 received a priority date of 09/05/2022 which is after the publication date of the reference. The rest of the claims received a priority date of 11/02/2021 and do fall under 102(a)(2). However, the applicants argument for commonly owned disclosure is not persuasive because it requires a signed statement claiming common ownership must be shown to exist not later than the effective filing date of the claimed invention. “A clear and conspicuous statement by the applicant (or the applicant's representative) that the claimed invention of the application under examination and the subject matter disclosed in the U.S. patent document applied as prior art were owned by the same person or subject to an obligation of assignment to the same person not later than the effective filing date of the claimed invention will be sufficient to establish that the AIA 35 U.S.C. 102(b)(2)(C) exception applies” MPEP 2154.02(c). In re Onda was pre-AIA . Double Patenting Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. The applicant argues that the reference ZAVORONKOVS does not qualify as prior art under 102(a)(1) because the publication of ZAVORONKOVS was after the priority date of the instant invention. However, this is not persuasive for claim 49 because a claim by claim analysis indicated a lack of support for the compounds: from the second row of compounds on instant claim page 24 through page 27. These compounds lacked support in the priority document PCTCN2021128243. Thus claim 49 received a priority date of 09/05/2022 which is after the publication date of the reference. The rest of the claims received a priority date of 11/02/2021 and do fall under 102(a)(2). However, the applicants argument for commonly owned disclosure is not persuasive because it requires a signed statement claiming common ownership must be shown to exist not later than the effective filing date of the claimed invention. “A clear and conspicuous statement by the applicant (or the applicant's representative) that the claimed invention of the application under examination and the subject matter disclosed in the U.S. patent document applied as prior art were owned by the same person or subject to an obligation of assignment to the same person not later than the effective filing date of the claimed invention will be sufficient to establish that the AIA 35 U.S.C. 102(b)(2)(C) exception applies” MPEP 2154.02(c). In re Onda was pre-AIA . Furthermore, since there are still remaining rejections besides the provisional nonstatutory double patenting rejection it has not been withdrawn. Conclusion Claims 1, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51, 63 are rejected. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off). 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) 270-5239. 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. /A.A.H./ Examiner, Art Unit 1627 /Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627