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 .
DETAILED ACTION
This is a response to Applicant’s communication filed on June 12, 2026. Application No. 18/622,057, is a U.S. Nonprovisional application, filed March 29, 2024, and claims the benefit of U.S. Provisional applications Nos.: 63/610,244, filed December 14, 2023; 63/587,861, filed October 4, 2023; 63/579,257, filed August 28, 2023; and 63/492,895, filed March 29, 2023. In a preliminary amendment filed July 15, 2024, Applicant cancelled claims 2, 3, 7, 9, 10, 13-15, 23, 28, 32, 35, 39, 46-61, 63, and 64; and added new claims 65 and 66. Claims 1, 4-6, 8, 11, 12, 16-22, 24-27, 29-31, 33, 34, 36-38, 40-45, 62, 65, and 66 are pending.
Election/Restriction
Applicant’s elections without traverse of the invention of Group I and the species Compound 249, in the reply filed on June 12, 2026, are acknowledged.
Claims 38, 40-45, 62, and 66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. The elections were made without traverse in the reply filed on June 12, 2026.
Claims 1, 4-6, 8, 12, 16-18, 20, 21, 27, 29, 30, 34, 36, 37, and 65 are examined below.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 1, 12, 17, 18, 20, 21, 27, 29, 30, 34, 36, 37, and 65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brizgys et al., WO2022/109182 (cited on the September 25, 2025, IDS) (citing the CAS Abstract for the compounds disclosed therein). The CAS Abstract for Brizgys discloses the following compounds and pharmaceutical compositions thereof:
PNG
media_image1.png
266
685
media_image1.png
Greyscale
PNG
media_image2.png
266
685
media_image2.png
Greyscale
PNG
media_image3.png
266
685
media_image3.png
Greyscale
PNG
media_image4.png
295
685
media_image4.png
Greyscale
PNG
media_image5.png
289
685
media_image5.png
Greyscale
PNG
media_image6.png
134
150
media_image6.png
Greyscale
(Brizgys et al., citing the CAS Abstract for the compounds depicted above; see Brizgys et al., WO ‘182, Abstract, for pharmaceutical compositions thereof.) The compounds read on compound of Formula (I**), wherein Formula (I**), R1 is halogen, R2 is –(O)-alkyl, heterocyclyl, or -CN, n is 1 or 2; R12 is -C(O)OH; X3 is CH; X6 is CR4, where R4 is hydrogen or halogen; X1 is CH2; Ring A is piperidine; L’ is a bond; Ring B is heteroarylene (pyrdinene), L is a -O-CH2 alky; and Ring C is a halogen and -CN substituted phenyl (aryl) ring.
Claims 1, 6, 8, 12, 16, 17, 20, 21, 27, 29, 30, 34, 36, 37, and 65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al., WO2022/001237 (cited on the September 25, 2025, IDS) (citing the CAS Abstract for the compounds disclosed therein). The CAS Abstract for Xu discloses the following compounds and pharmaceutical compositions thereof:
PNG
media_image7.png
375
646
media_image7.png
Greyscale
PNG
media_image8.png
343
658
media_image8.png
Greyscale
PNG
media_image9.png
343
646
media_image9.png
Greyscale
PNG
media_image10.png
373
646
media_image10.png
Greyscale
PNG
media_image11.png
375
646
media_image11.png
Greyscale
PNG
media_image12.png
343
658
media_image12.png
Greyscale
(Xu et al., citing the CAS Abstract for the compounds depicted above; see Xu et al., WO ‘237, Abstract, for pharmaceutical compositions thereof.) The compounds read on compound of Formula (I**), wherein Formula (I**), R1 is –(O)-X4, X4 is an alkyl, haloalkyl, or deuterium substituted alkyl; R2 is heterocyclyl, n is 1; R12 is -C(O)OH; X3 and X6 are CH; X1 is CH2; Ring A is azabicyclo[3.1.0]hex-e-yl; L’ is a bond; Ring B is heteroarylene (pyrdinene), L is a -O-CH2 alky; and Ring C is a halogen, -CN, or methoxy substituted phenyl (aryl) ring.
Claim Rejections - 35 USC § 102(a)(2)
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)(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.
Claims 1, 6, 8, 12, 16, 17, 20, 21, 27, 29, 30, 34, 36, 37, and 65 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Polla et al., WO2023/111144, which claims the benefit of U.S. Provisional application No. 63/265496, filed December 16, 2021 (cited on the September 25, 2025, IDS) (citing the CAS Abstract for the compounds disclosed therein). The CAS Abstract for Polla discloses the following compounds and pharmaceutical compositions thereof:
.
PNG
media_image13.png
318
699
media_image13.png
Greyscale
PNG
media_image14.png
318
699
media_image14.png
Greyscale
PNG
media_image15.png
378
699
media_image15.png
Greyscale
PNG
media_image16.png
378
669
media_image16.png
Greyscale
PNG
media_image17.png
378
669
media_image17.png
Greyscale
PNG
media_image18.png
318
669
media_image18.png
Greyscale
PNG
media_image19.png
311
669
media_image19.png
Greyscale
PNG
media_image20.png
318
665
media_image20.png
Greyscale
PNG
media_image21.png
318
636
media_image21.png
Greyscale
PNG
media_image22.png
326
665
media_image22.png
Greyscale
PNG
media_image23.png
318
661
media_image23.png
Greyscale
PNG
media_image24.png
410
699
media_image24.png
Greyscale
(Polla et al., citing the CAS Abstract for the compounds depicted above; see Polla et al., WO ‘144, Abstract, for pharmaceutical compositions thereof.) The compounds read on compound of Formula (I**), wherein Formula (I**), R1 -O-CH3; R2 is heterocyclyl or heteroaryl, and n is 1; R12 is -C(O)OH; X3 and X6 are CH; X1 is CH2; Ring A is azabicyolo[3.1.0]hex-3-yl; L’ is a bond; Ring B is an optionally substituted heteroarylene (pyrdinene), L is a -O-CH2 alky; and Ring C is a halogen, alkyl, haloalkyloxy, and/or -CN substituted phenyl (aryl) ring.
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, 4-6, 8, 12, 16-18, 20, 21, 27, 29, 30, 34, 36, 37, and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No.12,485,118. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘118 patent claim the same GLP-1 agonist claimed by the present invention.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY R ROZOF/
Primary Examiner, Art Unit 1625
Prosecution Insights