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
Status of the Claims
Claims 7, 9-12 are pending and are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on December 30th 2025 and November 25th 2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 112(b) Rejections Overcome by Amendment
Applicant’s amendments to claim 7 in the response filed on January 30th 2026 are acknowledged. Applicant has amended claim 7 to recite a patient population, thus overcoming the 112(b) rejections for claims 7 and 9-12.
35 U.S.C. § 102 Rejections Overcome by Amendment
Applicant’s amendments in the response filed on January 30th 2026 are acknowledged. Applicant has amended the claims to only recite a method of treating cachexia accompanied by ghrelin resistance, and to necessitate that the opioid kappa receptor agonist administered is either of formula (I) or (II). As Suzuki does not teach the treatment of cachexia accompanied by ghrelin resistance, all 102 rejections are withdrawn.
Nonstatutory Double Patenting Rejections Overcome by Amendment
Applicant’s amendments in the response filed on January 30th 2026 are acknowledged. Applicant has amended the claims to only recite a method of treating cachexia accompanied by ghrelin resistance. As co-pending Application No. 18/012,099 does not teach the treatment of cachexia accompanied by ghrelin resistance, the nonstatutory double patenting rejections over co-pending application No. 18/012,099 are withdrawn.
Nonstatutory Double Patenting Rejections Maintained
Applicant’s remarks in the response filed on January 30th 2026 are acknowledged. Regarding co-pending Application No. 17/769,454, applicant states, “Applicant notes the rejection is preliminary in nature. As noted above, the claims as amended are believed to overcome the rejection.”
However, as described below, the reference claims obviate those of the instant application. Specifically, as the reference claims treat cachexia require both a compound of formula (I) and a ghrelin receptor agonist (i.e. a compound that would act on the ghrelin receptor to stimulate growh hormone release and increase hunger), one of ordinary skill in the art would have a reasonable expectation of success in using said combination to treat cachexia in a patient that also has ghrelin resistance. As the instant claims remain obvious over those of co-pending Application No. 17/769,454, the nonstatutory double patenting rejections over said application are maintained.
Nonstatutory Double Patenting Rejections Reiterated
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 7-12 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-16 of copending Application No. 17/769,454 (‘454 Application), which is directed towards a method of treating cachexia via administration of an identical compound to that of the instant application, alongside a ghrelin receptor agonist. As one of ordinary skill in the art would reasonably administer a ghrelin receptor agonist to a subject with ghrelin resistance (i.e. would apply the method of the ‘454 Application comprising administration of the instant compound to a subject with cachexia accompanied by ghrelin resistance), the instant claims are obvious over those of the ‘454 Application
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629