DETAILED ACTION
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
This application, filed 7 October, 2022, is a national stage application of PCT/US2021/026481, filed 8 April, 2021, which claims the benefit of U.S. Provisional Application 63/126,494, filed 16 December, 2020, U.S. Provisional Application 63/072,922, filed 31 August, 2020, U.S. Provisional Application 63/044,318, filed 25 June, 2020, and U.S. Provisional Application 63/007,331, filed 8 April, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 December, 2025 is acknowledged and has been considered.
Election/Restrictions
Applicant’s election without traverse of Group I and Species – Compound 265 in the reply filed on 11 August, 2025, is acknowledged.
Claims 23-24, 26, 28, 30, 32, 34, 43-48, 50, 52, 55-56, 58, 67-70, 77-78, 80-83, and 86-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim.
Based on amendment, the broader genus of claimed species within Group I does not read on prior art and therefore, the species election within Group I has been withdrawn.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 29 December, 2025, in the matter of Application N° 17/917,729. Said documents have been entered on the record.
Claims 1-2, 8, 20, 22 and 75 are amended. Claims 18-19, and 21 are canceled. No new matter has been introduced.
Thus, Claims 1-2, 6, 8, 12, 14, 20, 22, 71-72, and 75 represent all claims currently under consideration.
Response to Amendment
Claims 18-19, and 21 have been canceled. Therefore, the rejections of these claims under 35 U.S.C. 102(a)(1), and Double Patenting are moot.
Applicant’s amendments are sufficient to overcome the prior rejection of Claims under 35 USC 112(b) and 102(a)(1).
The rejections of claims under non-statutory Double Patenting are maintained, or updated based on Amendment.
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting (MAINTAINED)
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 1-2, 6, 8, 12, 14, 20, 71-72 and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2, 4, 6, 8, 10, 18-23, 25, 27, 29, 31, 39-43 and 46 of copending Application No. 17/917,734 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the only differences reside in the position of substituents (i.e., positional isomers) and/or the placement of heteroatoms within the core claimed structure. Such variations represent obvious modifications that do not render the claimed compounds patentably distinct.
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- 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). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). See MPEP §2144.09(II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 6, 8, 12, 14, 20, 71-72 and 75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 3, 5, 18, 26, 35, 78, 84, 113, 123, 145, 160, 172, 216, 228, 240-241, 243-244, 268, 281, 298, 300, 324, 332, 334-335, 337, 339, 364, 371, 374, 407, 413, 415-416, and 431-432 of copending Application No. 17/700,632 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the only differences reside in the position of substituents (i.e., positional isomers) and/or the placement of heteroatoms within the core claimed structure. Such variations represent obvious modifications that do not render the claimed compounds patentably distinct.
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- 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). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). See MPEP §2144.09(II).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627