DETAILED ACTION
This office action is in response to applicant’s filing dated August 25, 2025.
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 .
Status of Claims
Claims 1-14 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed August 25, 2025.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a compound represented by the formula of claim 1:
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as the elected invention and a formulation species requiring no additional components in the reply filed on August 25, 2025 is acknowledged.
Claims 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 25, 2025.
Claims 1-5 are presently under examination.
Priority
The present application is a continuation of US Application No. 18/785,844 filed on July 26, 2024, which is a divisional of US Application No. 17/922,804 filed on November 2, 2022, which is a 371 of PCT/US2021/030728 filed on May 4, 2021, which claims benefit of foreign priority to PCTCN2020088585 filed on May 5, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 22, 2025; July 2, 2025; and August 7, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,285,429 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a compound represented by the following structural formula:
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Previously allowed claims 1, 2, and 4-7 are directed to a compound represented by the following structural formula:
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or a pharmaceutically acceptable salt thereof. Previously allowed claims 3 and 8-12 are directed to a stereoisomer of the above compound or a pharmaceutically acceptable salt thereof. Each enantiomer of the previously allowed claims are claimed to have an optical purity of 70%, 90%, or 99%. The previously allowed claims also claim a pharmaceutically composition comprising said compounds or pharmaceutically acceptable salts. Thus, the compound of previously allowed claims 1, 2, and 4-7 would anticipate the instantly claimed compound. Previously allowed claims 3 and 8-12 are directed to a stereoisomer of the instantly claimed compound and 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). Thus, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the instantly claimed compounds from the compound of previously allowed claims 3 and 8-12.
Conclusion
Claims 1-5 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628