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 .
Priority
Instant application 18/850,362 filed on 09/24/2024 claims benefit as follows:
CONTINUING DATA:
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Status of the Application
Claims 70-100 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/23/2026, 01/21/2026, 12/15/2025, 10/31/2025, 09/26/2025, 09/29/2025, 07/31/2025, 05/30/2025, 04/30/2025, 03/28/2025, 02/27/2025 and 01/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 70-82, 85-95 and 96-100 are rejected under 35 U.S.C. 102(a)(1) as being anticipated WO-2020169850-A1 (published August 27, 2020) evidenced by Buyukdura (Buyukdura et al., Progress in Neuro-Psychopharmacology & Biological Psychiatry 35 (2011) 395–409).
WO-2020169850-A1 teaches and claims 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for use in treating depression (see title and claim 1).
Further, WO-2020169850-A1 teaches evaluation of motor retardation (see p. 118, last 6 lines):
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As evidenced by Buyukdura, psychomotor retardation is a major feature of depression (see abstract and introduction):
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Since WO-2020169850-A1 teaches and claims 5-MeO-DMT is effective in treating depression, the treatment inherently treats (reduces or eliminates) features of depression including psychomotor retardation, a result that logically flows from the administration of 5-MeO-DMT recited by WO-2020169850-A1.
Regarding instant claim 72, WO-2020169850-A1 teaches use of 5-MeO-DMT in mental disorders:
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Further, WO-2020169850-A1 teaches current major depressive episode (see p. 130, first paragraph):
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Further, WO-2020169850-A1 teaches treatments of resistant form of major depressive disorder (see page 19, third paragraph):
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Regarding claim 79, WO-2020169850-A1 teaches an improvement is observed not later than 2 hours after the last administration of 5-MeO-DMT (“2 hours after the last administration of 5-MeO-DMT” meets the instant limitations “observed on day 1 after the last administration of 5-MeO-DMT”):
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Regarding claim 80, WO-2020169850-A1 teaches that improvement persist until at least 14 days after the last administration (see claim 25). Therefore, the WO-2020169850-A1 meets the limitation of improvement observed on day 7.
Regarding claim 85, WO-2020169850-A1 teaches and claims the same dosage as recited in the instant claims:
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Regarding claim 86, WO-2020169850-A1 teaches at least one administration within 24 hours (see claim 15):
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Regarding claims 87, 88 ,90 and 92, WO-2020169850-A1 teaches each subsequent administration uses a higher dosage amount unless the patient experiences a peak psychedelic experience:
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Regarding claim 91, WO-2020169850-A1 teaches:
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Regarding claim 94, WO-2020169850-A1 teaches:
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Regarding claim 95, WO-2020169850-A1 teaches:
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Regarding claim 96, WO-2020169850-A1 teaches Peak Experience Scale Total Score of at least 75 (see page 23, 5th paragraph):
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Regarding claim 97, WO-2020169850-A1 teaches 5-MeO-DMT is administered via inhalation:
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Regarding claim 98, WO-2020169850-A1 teaches 5-MeO-DMT is administered by nasal administration (see page 23, 6th paragraph):
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Regarding claim 100, WO-2020169850-A1 teaches 5-MeO-DMT is administered at a dose sufficient to result in the patient having a peak psychedelic experience (see page 34):
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As discussed above, treating depression inherently treats (reduces or eliminates) features of depression including psychomotor retardation, a result that logically flows from the administration of 5-MeO-DMT. It should be noted "where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the characteristics relied on"); In
re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (indicating that the burden of proof can be shifted
to the applicant to show that the subject matter of the prior art does not possess the characteristic
relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness under 35
U.S.C. 103 (MPEP 2183).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 70-100 are rejected under 35 U.S.C. 103 as being unpatentable over WO-2020169850-A1 (published August 27, 2020) in view of Buyukdura (Buyukdura et al., Progress in Neuro-Psychopharmacology & Biological Psychiatry 35 (2011) 395–409) and in view of Busner (Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
The teachings of WO-2020169850-A1 and Buyukdura have been discussed above, and those teachings are incorporated herein by reference.
As disused above, treating depression inherently treats (reduces or eliminates) features of depression including psychomotor retardation, a result that logically flows from the administration of 5-MeO-DMT.
Regarding claims 82-84 WO-2020169850-A1 does not teach Clinical Global Impression-Severity (CGI-S) scores.
Busner teaches Clinical Global Impressions Scale (CGI) is a research tool which “can make an expert clinical global judgment about the severity of the illness across various time points
within the context of that clinical experience” (see abstract and page 30).
Further, Busner teaches CGI has two components: the CGI-Severity, which rates illness severity, and the CGI-Improvement, which rates change from the initiation (baseline) of treatment (see page 30, What is the CGI).
Since CGI test is a widely recognized 7-point rating scale used by clinicians to measure the overall severity of a patient's illness (see page 30 of Busner), it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the tool of Busner with a reasonable expectation of success. One of ordinary skill would be motivated to use the additional test to monitor patients during treatments. The scores recited in instant claims are results of the administration steps and logically flows from the administration of 5-MeO-DMT.
It should be noted "where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the characteristics relied on"); In
re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (indicating that the burden of proof can be shifted
to the applicant to show that the subject matter of the prior art does not possess the characteristic
relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness under 35
U.S.C. 103 (MPEP 2183).
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 70-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 6, 15-17, 19-24 and 28-31 of copending Application No. 18/675,614 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/675,614 recite:
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Because psychomotor retardation is a major feature of depression, a person having ordinary skill in the art would expect that treatments for depression reduce psychomotor retardation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 70-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18,28, 32, 35-38 of copending Application No. 18/373,903 (reference application) in view of Garset-Zamani, (Sofie Garset-Zamani Infant Behavior and Development, Volume 61, 2020, 101486).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/373,903 recite a method of treating a patient suffering from postpartum depression (PPD), comprising administering to the patient an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT).
As taught by Garset-Zamani (see page 2, 3rd full paragraph), psychomotor retardation is a feature of postpartum depression (PPD), therefore, one of ordinary skill would expect that treatments of PPD reduce psychomotor retardation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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