DETAILED ACTION
This office action is in response to applicant’s filing dated March 5, 2026.
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 2-25 and 27-32 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed March 5, 2026. Acknowledgement is made of Applicant's amendment of claims 2, 17, and 27; and cancelation of claims 1 and 26.
Applicants elected with traverse Group III, drawn to a method for maintenance or improvement of body composition compared to semaglutide monotherapy, comprising co-administering to the subject a composition comprising a pharmaceutical composition of Formula IX, or an optical isomer, a racemic mixture, a pharmaceutically acceptable salt, a pharmaceutical product, a hydrate, an N-oxide, or a crystal thereof and a pharmaceutical composition of semaglutide in the reply filed on December 30, 2025. The requirement is still deemed proper.
Claims 2-25 and 27-32 are presently under examination.
Priority
The present application is a CIP of US Application No. 19/248,412 filed on June 24, 2025, which is a CIP of US Application No. 19/037,276 filed on January 26, 2025, which is a CIP of US Application No. 18/905,976 filed on October 3, 2024, which claims benefit of priority to US Provisional Application Nos. 63/587,708; 63/608,780; 63/644,426; and 63/660,989 filed on October 3, 2023; December 11, 2023; May 8, 2024; and June 17, 2024.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional Application No. 63/587,708; 63/608,780; 63/644,426; and 63/660,989, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
In a review of the prior applications, disclosure of “wherein the loss in lean body mass if from about 3% to 20% of the total body weight in the subject” (instant claim 5); “reducing subcutaneous or intramuscular fat accumulation” (instant claim 7); “A method for reducing or treating rebound in a subject in need thereof” (instant claims 27-30); or “semaglutide is formulated for administration at a dose of from 0.25 mg per week to 1.7 mg per week” (instant claims 31 and 32) was not identified in the ‘708, 780, ‘426, or ‘989 Applications. Thus, the effective filing date of claims 5, 7, and 27-32 is October 3, 2024.
In a review of the prior applications, disclosure of “wherein the bone fractures are fractures of the hip or pelvis in the subject” (instant claim 10) was not identified in the ‘708 or 780 Applications. Thus, the effective filing date of claim 10 is May 8, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 23, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Withdrawn Objections and/or Rejections
Double Patenting
The terminal disclaimer filed on February 23, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Nos. 18/905,976; 19/037,276; and 19/248,412 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the provisional rejections of claims 2-25 and 27-32 on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/905,976 (reference application); over claim 1-38 of copending Application No. 19/037,276 (reference application); and over claim 1-42 of copending Application No. 19/248,412 (reference application) has been withdrawn.
Maintained Objections and/or Rejections
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 2-25 and 27-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-38 of copending Application No. 19/345,346 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method for reducing or treating adverse effects caused by semaglutide monotherapy in a subject, comprising co-administering to the subject a composition comprising a pharmaceutical composition of Formula IX and the a pharmaceutical composition of semaglutide; a method for maintenance or improvement of body composition compared to semaglutide monotherapy in a subject, comprising co-administering to the subject the a composition comprising a pharmaceutical composition of Formula IX and the a pharmaceutical composition of semaglutide; and a method for reducing or treating rebound in a subject in need thereof, wherein the rebound is in one or more of (i) weight gain, (ii) fat mass gain, and (iii) lean mass loss when the semaglutide is discontinued in said subject but Formula IX treatment continues as monotherapy; wherein the subject was previously administered the composition of claim 1 a composition comprising a pharmaceutical composition of Formula IX and a pharmaceutical composition of semaglutide; wherein Formula (IX) has the structure:
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The copending claims are directed to a method for preventing, reducing, or treating adverse effects caused by an incretin agonist or antagonist containing drug monotherapy comprising co-administering to the subject a pharmaceutical composition of a SARM compound and an incretin agonist or antagonist (see claim 15), wherein said SARM compound is Formula (IX) (see claim 10) and the incretin agonist or antagonist includes semaglutide (see claim 6); wherein the method decreases fat mass while preserving or increasing lean mass (see claim 19). The copending claims are directed to a method for maintenance or improvement of body composition (claim 30) and reducing or treating rebound in a subject (see claim 34).
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 method with a reasonable expectation of success from the method of the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues:
Application under examination has the earlier patent term filing date. If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 804 states:
The patent term filing date of an original utility or plant application filed on or after June 8, 1995 is the earliest of:
(1) The actual filing date of the application; or
(2) The filing date of the earliest application for which the application claims the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c). See 37 CFR 1.78. See also MPEP § 211.
In the instant case, the earliest patent date is the filing date of the earliest application for which the application claims benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c), US Application No. 18/905,976, which is October 3, 2024.
The copending case also claims benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) to US Application No. 18/905,976. Thus, the copending case and the instant case have the same patent term filing date.
MPEP 804 states:
If 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. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection.
Thus, the provisional rejection is maintained.
Conclusion
Claims 2-25 and 27-32 are rejected.
No claim is allowed.
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.
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.
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, 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