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
This is a response to Applicant’s communication filed on June 24, 2025. Application No. 18/851,349, is a 371 of PCT/EP2023/057828, filed March 27, 2023, and claims foreign priority to European Patent applications Nos.: EP 22000085.5, filed March 27, 2022; EP 22000084.8, filed March 27, 2022; EP 23154014.7, filed January 30, 2023; and EP 23153996.6, filed January 30, 2023. In a preliminary amendment filed June 24, 2025, Applicant cancelled claims 1-112, and added new claims 113-138. Claims 113-138 are pending.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 113-138 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fielding-Mellen et al., WO2021/250/0259147 (publ’d (December 16, 2021) (citing US2022/0259147 A1, as the U.S. equivalent). Fielding-Mellen discloses a method for treating sleep disturbance in a patient comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route. Fielding-Mellen et al., US PG ‘147, claim 98-100, for a method of treating treatment-resistant depression; see Id., p. 53, para. [1130]-[1131], for conditions caused by dysfunction of the peripheral nervous system benefiting sleep regulation (such as insomnia).
Claims 113-138 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fielding-Russ et al., US2020/0147033. Russ discloses a method for treating sleep disturbance in a patient comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route. Russ et al., US PG ‘038, p. 15, para. [0140]-[0141] for a method of treating anxiety disorders including sleep disturbances.
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.
Claim 113-138 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim of copending Application No. 18/851,346 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘346 application are drawn to the same methods of using 5-MeO-DMT claimed by the present invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No Claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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