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 16 February, 2021, is a national stage application of PCT/US2021/029828, filed 29 April, 2021, which claims the benefit of U.S. Provisional Application N° 63/149,803, filed 16 February, 2021, and U.S. Provisional Application N° 63/018,774, filed 1 May, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 25 September, 2025 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 25 September, 2025, in the matter of Application N° 17/997,594. Said documents have been entered on the record.
Claims 11-13, 35, 39-40, 43, 48, and 51 are amended. Claims 1-10, 14-34, and 36 are canceled. No new matter was introduced.
Thus, Claims 11-13, 35, and 37-53 represent all claims currently under consideration.
Response to Amendment
Applicant’s amendments and cancelations are sufficient to overcome the previous objections of Claims 26, 28, and 43-53, and rejections of Claims 33 and 48 under 35 U.S.C. 112(b), and Claims 1-10, 14-15, 21, 34-36, and 40-42 under 35 U.S.C. 103.
Claims 43-53 were objected to as they depended from multiple dependencies and were therefore not previously treated on the merits.
Below can be found new grounds of rejection necessitated by amendments.
Double Patenting
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 11-13, 35, and 37-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-7 of U.S. Patent N° 12,110,294.
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Although the claims at issue are not identical, they are not patentably distinct from each other because the instant genus claims are obvious over the patented species and compositions.
For example, Patent ‘294 Claim 1, Structure 1, shown top right, is fully encompassed by instant Formula I, shown bottom right, wherein W1 is N, W2 is C, Z1 and Z2 are each independently CR2 wherein R2 is H, Z3 is N, Y is a C3 cycloalkyl (cyclopropyl), and R1 is a C6 aryl (phenyl.)
The method claims do not present a patentably distinct invention from the compound or composition claims of Patent ‘294, since the methods merely recite administering or using previously claimed compounds or compositions for the same purpose taught therein.
Conclusion
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 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