DETAILED ACTION
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 the Claims
Claims 1, 4, 7-9, 11, 13, and 22-25 are pending. Acknowledgment is made of the amendment of claims 1, 4, 7-9, 11, and 13, the cancellation of claims 2, 3, 10, 12, and 16-21, and the addition of new claims 22-25, in the reply filed 06/15/2026.
Withdrawn Objections/Rejections
Applicant’s amendment to the claims, filed 06/15/2026, overcomes the objection to claims 3, 4, 7, 8, 10-13, 16-18, 20, and 21 for minor informalities. The objection to claims 3, 4, 7, 8, 10-13, 16-18, 20, and 21 has been withdrawn.
Applicant’s amendment to the claims, filed 06/15/2026, overcomes the rejection of claims 1-4, 7-13, and 16-21 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 1-4, 7-13, and 16-21 has been withdrawn.
Applicant’s amendment to the claims, filed 06/15/2026, overcomes the rejection of claims 1-4, 7-13, and 16-21 under 35 U.S.C. 112(b) for indefiniteness. The rejection of claims 1-4, 7-13, and 16-21 has been withdrawn.
Applicant’s amendment to the claims, filed 06/15/2026, overcomes the rejection of claim 10 under 35 U.S.C. 112(d) for failing to further limit the scope. The rejection of claim 10 has been withdrawn.
Applicant’s amendment to the claims, filed 06/15/2026, overcomes the rejection of claims 1-3, 7-13, and 17-21 under 35 U.S.C. 102(a)(1) as being anticipated by, and claims 4 and 16 under 35 U.S.C. 103 as being unpatentable over, Yoon et al. (WO 2018075481 A1). The newly amended claims no longer the administration of ketamine in combination with naltrexone. The rejection of claims 1-4, 7-13, and 16-21 has been withdrawn.
Maintained/Modified Rejections
Nonstatutory 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, 4, 7-9, 11, 13, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 4, 8, and 12-14 of copending Application No. 18/572,637 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 2, 12, and 13 of Application ‘637 teach a method of treating a cognitive or neurological disorder, including Alzheimer’s, PTSD, OCD, MND, depression, psychosis, anxiety, paranoia, panic attacks, and flashbacks comprising administering 0.01-10 mg naltrexone and a 5-HT agonist, as in instant claims 1, 4, 9, 22, 24, and 25. The 5-HT agonists of reference claim 4 reads on the agonists of instant claims 7 and 8. The administration methods of reference claims 8 and 14 reads on the formulation and administration techniques of instant claims 11, 13, and 23.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the nonstatutory provisional double patenting rejection in abeyance.
Examiner Responds:
MPEP 1490 V. D. 2. 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. … If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection.” Therefore, the provisional rejection is maintained.
Claims 1, 4, 7-9, 11, 13, and 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 7-13, and 16-21 of copending Application No. 18/572,651 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1, 2, 7-9, 17-19, of Application ‘651 teach a method of treating a neurological or cognitive disorder comprising administering naltrexone and a 5-HT agonist, as in instant claim 1, 24, and 25. The method includes the neurological and cognitive disorders listed in instant claim 9 and 22, and the 5-HT agonists listed in instant claims 7 and 8. The administration methods of reference claims 3, 4, 10-13, 16, 20 and 21 read directly on instant claims 4, 11, 13, and 23.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant Argues:
Applicant holds the nonstatutory provisional double patenting rejection in abeyance.
Examiner Responds:
MPEP 1490 V. D. 2. 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. … If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has the later patent term filing date, the rejection should be maintained until applicant overcomes the rejection.” Therefore, the provisional rejection is maintained.
New Claim Objections
Claim 1 is objected to because of the following informalities:
The compound name for TMA-2 should read “2,4,5-Trimethoxyamphetamine” instead of “2,4,5-Trimethox-amphetamine”. The “y” in “trimethoxy” is missing.
The compound name for TMA is missing the “y” in “trimethoxy”.
Compound “SR7227 hydrochloride” should read “SR 57227 hydrochloride”.
Compound “PSEM 895” should read “PSEM 89S”.
Compounds RR-2b and SS-2c both appear to be synonyms for the same compound, [(6aR)-7-methyl-6,6a,8,9-tetrahydro-4H-indolo[4,3-fg]quinolin-9-yl]-[(2R,4R)-2,4-dimethylazetidin-1-yl]methanone. Therefore, only one of the synonyms is needed in the claims.
Appropriate correction is required.
Conclusion
Claims 1, 4, 7-9, 11, 13, and 22-25 are rejected.
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 RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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