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 .
Issues Resolved
All issues in the Office Action mailed 04/21/2026 have been resolved, other than the issues set forth below.
The filing receipt dated 04/22/2026 removed a comma from Applicant’s name, as was requested in the corrected ADS filed 03/16/2026. Additionally, a miscellaneous communication mailed by the Office on 04/22/2026 refused entry of changes to domestic benefit information (the priority chain) in the corrected ADS filed 03/16/2026. Applicant (Remarks, p. 146) confirmed that they did not intend to change the priority chain. Applicant also confirmed that the filing receipt dated 04/22/2026 has correct information. Accordingly, a new corrected ADS is not needed.
Amendment to the Title Page
The amendment to section (71), i.e., the Applicant, on the title page was not part of the certificate of correction issued 10/03/2023 for the ‘660 patent and thus, must not be part of the amendment to the title page. A reissue patent for the instant application will display “Carmot Therapeutics Inc., South San Francisco, CA” as the Applicant, as per the filing receipt mailed 04/22/2026. It is requested that Applicant resubmit the amendment to the tile page without the change to section (71).
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 1-36 and 41-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/091,745 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1-36 and 41-45, claim 1 of the reference application is a broader compound genus than the compound genus set forth in instant claim 1. However, the reference application specification (section D spanning pp. 310-463) discloses numerous compound species within the scope of claim 1 of the reference application and also within the scope of the compounds in instant claims 1-36 and 41-45.
Since the reference application specification teaches numerous compound species within the scope of instant claims 1-36 and 41-45, it would have been obvious for a person of ordinary skill in the art to select such compound species to practice the compound genus in claim 1 of the reference application. One of ordinary skill in the art would understand that the instantly claimed compounds are within the scope of the generic compounds claimed in the reference application. Accordingly, claim 1 of the reference application renders obvious the compounds in instant claims 1-36 and 41-45.
Instant claims 26-31 and 43-45 further set forth methods of using the compounds. Instant claim 26 sets forth a method for modulating GLP-1R and/or GIPR activity. Instant claim 27 sets forth a method for treating GLP-1R and/or GIPR induced aversion, nausea and/or vomiting. Instant claims 28 and 43 set forth a method for increasing insulin levels in a subject. Instant claims 29 and 44 set forth a method for decreasing glucose levels in a subject. Instant claims 30 and 31 set forth a method for treating a disease, disorder, or condition selected from the group consisting of diabetes, NASH, obesity, fatty liver disease, and steatohepatitis. Instant claim 45 sets forth a method for treating metabolic syndrome, diabetes, obesity, obesity-related disorders, impaired glucose tolerance, insulin resistance, non-alcoholic steatohepatitis, fatty liver disease, or steatohepatitis.
However, all of the above uses are taught in the reference application specification as suitable uses of the compounds (see pp.10-11). As noted in MPEP 804.II.B.1, “when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”
It would have been obvious to one of ordinary skill in the art to have used the compound species within the scope of claim 1 of the reference application for the instantly claimed uses because such uses are taught in reference application specification as suitable uses of the compound. Accordingly, the methods in instant claims 26-31 and 43-45 are rendered obvious by claim 1 of the reference application.
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 July 21, 2026 have been fully considered but they are not persuasive.
With respect to the provisional non-statutory double patenting rejection, Applicant argues that the facts in the instant case are analogous to Allergan, and that is it wrong for a child patent application, i.e. the 19/091,745 reference application, to be cited as an obviousness double patenting reference against the parent (Remarks, pp. 149-150).
This argument is unpersuasive. Allergan is not on point since in Allergan, the parent had patent term adjustment and thus, was later expiring than the child. The CAFC ruled that a first-filed, first-issued patent claim in a patent family cannot be invalidated for obviousness double patenting by a later-filed, later-issued, earlier-expiring reference claim.
The ‘660 patent that is the subject of the instant reissue application is the first-filed and first issued in the family. However, the ‘660 patent does not have patent term adjustment and does not expire later than the 19/091,745 reference application. In fact, the instant reissue application and the 19/091,745 reference application expire on the same date and have the same patent term filing date. As noted in MPEP 1490.VI.D.2(b), “[i]f both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome.” Accordingly, the instant provisional non-statutory double patenting rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,535,660 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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