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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed June 23rd, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Election/Restrictions
Claims 1 – 14, and 18 – 26 are currently pending in the application. However, due to a restriction requirement, claims 3 – 4, 6 – 9, 11 – 12, 20, and 23 – 25 are withdrawn from further consideration and claims 1 – 2, 5, 10, 13 – 14, 18 – 19, 21 – 22, and 26 are being examined on the merits herein. Nevertheless, upon the initial search the elected specie
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was found to be free of the prior art; therefore, the search was expanded to include all non-elected species. Consequently, claims 3 – 4, 6 – 9, 11 – 12, and 20 are rejoined and will be examined on the merits. Thus, the election of species required in the Restriction Requirement mailed December 4th, 2025 is withdrawn; but, the restriction between Group I and Group II is maintained.
Hence claims 1 – 14, 18 – 19, 21 – 22, and 26 are being examined on the merits.
Claim Rejections - 35 USC § 102
Response to Arguments
Applicant’s arguments and claim amendments, see page 11 – 12, filed June 23rd, 2026, with respect to the 35 U.S.C. 102(a)(1) rejection of claims 1 – 2, 5, 10, and 22 have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) rejection of claims 1 – 2, 5, 10, and 22 has been withdrawn.
Claim Rejections - 35 USC § 103
Response to Arguments
Applicant’s arguments and claim amendments, see page 12 – 13, filed June 23rd, 2026, with respect to the 35 U.S.C. 103 rejection of claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1 – 2, 5, 10, 13 – 14, 18 – 19, and 21 – 22 has been withdrawn.
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 1 – 14, 18 – 22, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5, 8 – 11, 12, 14, 16, 18, 21 – 24, 28 – 29, and 30 – 31 of U.S. Patent No. US 12528791 B2 to Kirschberg et. al. (herein after Kirschberg’791; cited in the IDS dated March 3rd, 2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the conflicting copending application and the invention direct to a compound of formula (I),
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(reference claims 1 and 30; instant claims 1 and 21) wherein
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is
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(reference claims 5, and 8 – 10; instant claim 1); wherein A is
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(reference claim 2; instant claims 1 – 2); wherein Z1-3 are CH (reference claims 12, 14, 16, and 18; instant claim 1); wherein R1 is cyclopropyl (reference claims 21 – 22, and 24; instant claims 5, 10, and 18 – 19); and wherein R2 is ethyl disubstituted with F (reference claim 23 and 28 – 29; instant claims 13 – 14). Moreover, both copending applications direct to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient (reference claim 31; instant claim 22).
Claims 1 – 14, 18 – 22, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 9 – 11, 18, 21 – 23, 28 – 31, 35, and 37 – 39 of copending Application No. 19/426869 to Kirschberg et. al. (reference application; herein after Kirschberg’869).
Although the claims at issue are not identical, they are not patentably distinct from each other because both conflicting copending applications direct to a compound of formula (I),
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(reference claims 1 and 30; instant claims 1 and 21) wherein
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is
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, and
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(reference claims 5, 7, and 10; instant claims 1 and 21); wherein A is
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(reference claims 2 – 3; instant claims 1 – 2); wherein Z1-3 are CH (reference claims 12, 14, 16, and 18; instant claim 1); wherein R1 is cyclopropyl (reference claims 21 – 22; instant claims 5, 10, and 18 – 19); and wherein R2 is ethyl disubstituted with F (reference claim 23; instant claims 13 – 14). Moreover, both copending applications direct to a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient (reference claim 31; instant claim 22).
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 June 23rd, 2026 have been fully considered but they are not persuasive.
Applicant states that until claims are deemed allowable there is no real way of assessing the merits of the double patent rejections or determining whether the filing of a terminal disclaimer is appropriate. See applicants remarks page 14 paragraph 7.
The examiner maintains that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804.
Discussion of the closet prior art
The teachings of the closet prior art of International Publication Number WO 2020/169069 A1 to Zhang et. al. (herein after Zhang’069; cited in the IDS dated August 28th, 2025) as they relate to the prior art rejection of claims 1 – 14, 18 – 22, and 26 are given in the office action dated March 23rd, 2026 and are incorporated here. However, Zhang’069 does not teach a compound where instant R1 is as delineated in amended claim 1 in combination with the benzodiazole scaffold. Moreover, Zhang’069 fails to teach any compound that renders obvious the compounds of claim 21. Moreover, the prior art of Zhang’069 fails to provide motivation to make the modifications needed to anticipate or render obvious the compound species of claim 21. Thus claims 1 – 14, 18 – 22, and 26 are free of the prior art.
Conclusion
Claims 1 – 14, 18 – 22, and 26 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 DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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