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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed December 27, 2024, is a reissue of U.S. Patent 11,535,660 (hereinafter the ‘660 patent), which issued from U.S. application Serial No. 17/040,653 (the ‘653 application) with claims 1-34 on December 22, 2022.
Maintenance Fee
Applicant is reminded that the 3.5-year maintenance fee is currently due for the ‘660 patent. As noted in MPEP 1415.01, “[i]f maintenance fees have not been paid on the original patent as required by 35 U.S.C. 41(b) and 37 CFR 1.20, and the patent has expired, no reissue patent can be granted.”
Application Data Sheet (ADS)
The Corrected ADS filed 03/16/2026 would change the 371 and provisional application data to state that the instant reissue application (i.e., the “null” entry) is a 371 of PCT/US19/23726, and that the instant reissue application (i.e., the “null” entry) claims the benefit of provisional application 62/647,604. Such is clearly incorrect. Accordingly, none of the corrections in the Corrected ADS will be entered. Since the Domestic Benefit/National Stage information in the ADS filed 12/27/2025 is correct, it is suggested that Applicant file a new Corrected ADS where the only changes made relative to the ADS filed 12/27/2024 are the Assignee name changes. A new Request to Correct or Update the Name of Applicant should also be filed with the new Corrected ADS.
Incomplete Document
MPEP § 1410 requires (emphasis added):
The copy of the printed patent must be submitted in double column format, each page of double column format being on only one side of the piece of paper. It should be noted that a re-typed specification is not acceptable in a reissue application; the full copy of the printed patent must be used.
The copy of the printed patent provided in the reissue file is incomplete since it is missing page 2, which follows the cover (abstract) page of the ‘660 patent. This page includes foreign patent documents and other publications. See also 37 CFR §1.173(a)(1). Applicant is required to provide a copy of page 2.
Certificate of Correction (CofC)
A copy of the CofC which issued October 3, 2023 is present in the reissue application. As noted in MPEP 1411.01, “[t]he applicant should include any changes, additions, or deletions that were made by a certificate of correction to the original patent grant in the reissue application without underlining or bracketing. This includes changes made by a certification of correction dated before the filing of the reissue application or dated during the pendency of the reissue application. The examiner should make certain that all certificate of correction changes in the patent have been properly incorporated into the reissue application.”
The CofC made a change to the title page. However, Applicant has not included in the present reissue application the change to the title page. Accordingly, as per the CofC, Applicant should provide an amendment to the tile page without underling or bracketing. For example, the amendment may recite:
On the Title Page: Under Item (73), please correct the Assignee name from “Cannot Therapeutics, Inc.” to --Carmot Therapeutics, Inc.--.
Non-Compliant Amendment
The amendment to the specification filed 12/27/2024 and the amendment to the claims filed 06/04/2025 are improper. The amendments do not comply with 37 CFR 1.173 which sets forth the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, Applicant’s next response should be a compliant amendment. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and (2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
The amendment to the specification has changed the two occurrences of “Mar.” to “March” without underlining and single bracketing.
The amendment to the specification indicates the month “March” to be deleted. However, col. 1, line 19 of the ‘660 patent specification recites “Mar.” not “March”. Accordingly, the amendment should be re-presented with “Mar.” to be deleted.
In claim 1, the fourth through fifth lines from the bottom on p. 7 of the amendment have added the phrase “(e.g., amide or tetrazolyl)” to claim 1 without underlining.
In claim 1, the fourth through fifth lines from the top on p. 8 of the amendment have added the phrase “(e.g., R4 and R3, taken together with the atoms to which each is attached form a ring including 5-8 ring atoms)” without underlining.
In claim 1, the tenth line from the top on p. 9 of the amendment has changed “-N(R’)(R’’)” to “- -N(Ra)(R’’)” without underlining and single bracketing. Note the extra hyphen should not be present since it is not present at col. 445, line 18 of the ‘660 patent and thus, should be left out of the term. It appears that the R’ should be Ra based on the Examiner’s Amendment mailed 06/23/2022 during prosecution of the ‘660 patent. The change from R’ in the issued claim to Ra will require single bracketing and underlining.
Amended claim 17 has changed “n + p ≥ 2” in issued claim 17 to “n + p > 2” without using single bracketing and underlining.
Multiple Dependent Claim Objection
Claims 37-40 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim must refer back to preceding claims, not to later claims. In particular, claims 37-40 depend from later claim 41. See MPEP § 608.01(n).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-23 and 25-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 has two instances of a broad range followed by a narrower range:
In a first instance, claim 1 recites the broad recitation “R3 is -C(O)OH, -C(O)OR31, -CH(C(O)OH)2 or a carboxylic acid isostere”, and the claim also recites “(e.g., amide or tetrazolyl)” which is the narrower statement of the range/limitation. See the fourth through the fifth line from the bottom on p. 7 of the reissue amendment.
In a second instance, claim 1 at page 8 of the amendment recites the broad recitation “R2’ and R4 taken together with the atoms connecting them form a ring including from 5-8 ring atoms, wherein from 3-7 are ring carbon atoms each substituted with from 1-2 substituents independently selected from H, halo, hydroxy, oxo, and C1-3 alkyl; and from 0-1 is a heteroatom (in addition to the N attached to R1) selected from O, -NH, -N(C1-3 alkyl), and S”, and the claim also recites “(e.g., R4 and R3, taken together with the atoms to which each is attached form a ring including 5-8 ring atoms)” which is the narrower statement of the range/limitation.
Claim 1 is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The same applies to dependent claims 2-23 and 25-34.
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 1-41 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 1-41, 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 1-41.
Since the reference application specification teaches numerous compound species within the scope of instant claims 1-41, 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 1-41.
Instant claims 26-31 and 38-40 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 38 set forth a method for increasing insulin levels in a subject. Instant claims 29 and 39 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 40 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 38-40 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.
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.
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.
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
Prosecution Insights