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 .
Claims 56-75 are pending in the application.
This action is in response to applicants' amendment dated January 12, 2026. Claims 63, 68 and 72 have been amended.
Response to Amendment
Applicant's arguments filed January 12, 2026 have been fully considered with the following effect:
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, labeled paragraph 1a) and b) in the last office action, which are hereby withdrawn.
The applicant's amendments and arguments are sufficient to overcome the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 2) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the nonstatutory double patenting rejection, labeled paragraph 3) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the nonstatutory double patenting rejection, labeled paragraph 4) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the nonstatutory double patenting rejection, labeled paragraph 5) in the last office action, which is hereby withdrawn.
The applicant's filing of a terminal disclaimer is sufficient to overcome the nonstatutory double patenting rejection, labeled paragraph 6) in the last office action, which is hereby withdrawn.
In view of the amendment dated January 12, 2026, the following new grounds of rejection apply:
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 56-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1541365-83-6 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclobutyl and Y1 is -C(=O)OH.
Claim(s) 56-59 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1280061-59-7 where n is 2, R1 is methyl; R2 is methyl; X1 is -C(O)NH-; A1 is 2-butoxyphenyl and Y2 is methoxy.
Claim(s) 56-58 and 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1050831-16-7 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is 1,2,3,4-tetrahydronaphthalenyl.
Claim(s) 56-58 and 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 422537-28-8 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is 4-phenoxyphenyl.
Claim(s) 56-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1775586-63-4 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclobutyl and Y1 is 1-(hydroxymethyl).
Claim(s) 56-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1713613-74-1 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclopropyl and Y1 is 1-(hydroxymethyl).
Claim(s) 56-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1487377-87-6 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclopentyl; and Y1 is 1-(aminomethyl).
Claim(s) 56-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1486188-70-8 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclopentyl; and Y1 is 1-(hydroxymethyl).
Claim(s) 56-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS registry number 1477723-10-6 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclopentyl; and Y1 is 2-(aminomethyl).
Claim(s) 56, 62-65 and 67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marugan et al., WO 2012/078855 (U.S. Patent No. 9,353,117) where n is 2, R1 is methyl, cyclopropyl, difluoromethyl, etc.; R2 is H; X1 is -C(O)NH-; A1 is phenyl substituted by phenyl, 1,2,3,4-tetrahydronaphthalen-1-yl, etc.; Y1 is and Y2 is cyano, NH2, methoxy, methyl, etc. as set forth in Compound # NCGC00182176-01, CGB2-39-1, CGB2-41-1, CGB2-42-1, CGB2-43-1, CGB2-62-1, CGB2-63-1, CGB2-56-1, CGB2-57-1, CGB2-58-1, CGB2-59-1, CGB2-60-1, CGB2-67-1, etc.
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 56-58 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 114 and 118 of copending Application No. 2025/0340558 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound and composition of the instant application embraces the compositions of U.S. ‘340558 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclohexyl and Y1 is -O-CH2-CH2-CH2-CH2-CH3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 56-58 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of copending Application No. 19/160,807 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound and composition of the instant application embraces the compositions of U.S. ‘807 where n is 2, R1 is methyl; R2 is H; X1 is -C(O)NH-; A1 is cyclohexyl and Y1 is -O-CH2-CH2-CH2-CH2-CH3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 60 and 66 are 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.
Allowable Subject Matter
Claims 68-75 are allowed. None of the prior art of record nor a search in the pertinent art area teaches the compounds, compositions and method of use of the compounds of Formula (IIa) and (III) as claimed herein.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on January 12, 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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, Jeffrey H. Murray can be reached at 571-272-9023. 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.
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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