DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. The election of species requirement dated December 19, 2025 is withdrawn.
Information Disclosure Statement
3. The information disclosure statements (dated January 22, 2024 and April 23, 2024 and April 21, 2025 and December 30, 2025 and March 31, 2026 and May 27, 2026) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
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.
4. Claims 4-7, 17 and 19 recite the limitation "said treatment.” There is insufficient antecedent basis for this limitation in the claim. The independent claim does not recite a treatment.
Claim Rejections - 35 USC § 102
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.
5. Claim(s) 1, 4-7, 15, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CorceptTherapeutics. The reference has a date of November 8, 2019 which antedates the present claims having a filing date of December 11, 2020 and priority claim to provisional application dated December 11, 2019.
The reference teaches the administration of 10 mg of olanzapine (an antipsychotic medication) and either placebo or 600 mg of miricorilant. The reference teaches that miricorilant significantly reduces amount of weight gain: subjects receiving olanzapine plus placebo gained an average of 3.5 kg, subjects receiving the combination gained 2.6 kg at 7 days. At 14 days the difference widened (5 kg vs. 3.9 kg). The reference also teaches levels of liver enzymes, ALT and AST, markers of liver damage increased less markedly in the miricorilant group. The reference also teaches that miricorilant is effective in both preventing and reversing olanzapine-induced weight gain. The reference is a transcript outlining results from clinical trial (see reference of ClinicalTrials), which evidences oral administration.
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.
6. Claims 1, 4-7, 15, 17 and 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,903,945. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons provided below.
The claims are directed to method of treating a subject suffering from antipsychotic-induced weight gain, comprising administering to the subject an effective amount of GRM miricorilant
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. Treatment includes amelioration.
The present claims anticipate the claims of the patent.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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