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
The present application claims priority to the following applications: PCT/EP2023/057873, EP 22000086.3, EP 23153939.6, EP 23153995.8, and EP 22000083.0, with effective filing dates of 27 March 2023, 27 March 2022, 30 January 2023, 30 January 2023, and 27 March 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Amendment filed, 12 December 2023, wherein the Applicant amended claims 1-36.
Claim 1-36 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed in the below table and the references cited therein have been considered, unless indicated otherwise.
IDS Filing Date
Document Identifier
22 January 2024
P69742 05985799.DOC
22 January 2024
P69742 05985815.DOC
22 January 2024
P69742 05985823.DOC
22 January 2024
P69742 05985853.DOC
22 January 2024
P69742 05985854.DOC
22 January 2024
P69742 05985869.DOC
22 January 2024
P69742 05985907.DOC
22 January 2024
P69742 05985955.DOC
22 January 2024
P69742 05985972.DOC
22 January 2024
P69742 05985986.DOC
22 January 2024
P69742 05986055.DOC
22 January 2024
P69742 05986071.DOC
22 January 2024
P69742 05986079.DOC
22 January 2024
P69742 05986088.DOC
22 January 2024
P69742 05986140.DOC
22 January 2024
P69742 05986101.DOC
22 January 2024
P69742 05986153.DOC
22 January 2024
P69742 05987654.DOC
23 July 2024
P69742 06237976.DOC
23 July 2024
P69742 06237988.DOC
23 July 2024
P69742 06237990.DOC
23 July 2024
P69742 06238000.DOC
23 July 2024
P69742 06238005.DOC
23 July 2024
P69742 06238006.DOC
23 July 2024
P69742 06238017.DOC
23 July 2024
P69742 06238018.DOC
23 July 2024
P69742 06252472.DOC
23 July 2024
P69742 06238009.DOC
23 July 2024
P69742 06238015.DOC
23 July 2024
P69742 06237978.DOC
26 August 2024
P69742 06289659.DOC
27 September 2024
P69742 06317410.DOC
28 October 2024
P69742 06370895.DOC
26 November 2024
P69742 06409509.DOC
27 December 2024
P69742 06438322.DOC
31 January 2025
P69742 06491350.DOC
27 February 2025
P69742 06523661.DOC
28 March 2025
P69742 06561924.DOC
30 April 2025
P69742 06601495.DOC
30 May 2025
P69742 06640467.DOC
31 July 2025
P69742 06718174.DOC
29 August 2025
P69742 06753887.DOC
26 September 2025
P69742 06788974.DOC
31 October 2025
P69742 06832069.DOC
15 December 2025
P69742 06888655.DOC
The references, wherein a copy was provided but is illegible, are lined through. These references are the following: Kurtz, J.S. Cureus, 2022, 14(9) (P69742 06238006.DOC); Harwood, Experimental Chemistry-Organic Chemistry and Reaction, 1998, 129-130 (P69742 06237976.DOC); Zal, Science.org, 2008, XP093099402 (P69742 06237976.DOC); M.V. Uthaug, Beyond Psychedics, 2018 (P69742 06237990.DOC); Suryawashi, Cureus, 2022, 14(12), e32745 (P69742 06491350.DOC); GH Research PLC, GH Research Announced Successful Outcome of the Phase 2 part of its Phase 1/2 Trial of GH001 in Treatment-Resistant Depression, GlobalNewswire (P69742 06491350.DOC), How Much and How Often to Breastfeed, CDC, 2022 (P69742 06491350.DOC); and Devlin, October 11-14, 2025, PS03-2265 (P69742 06888655.DOC).
The references, wherein a copy was not provided are lined through. These references are the following: E Susser, World Psychiatry, 2018, 17(3), 357-358 (P69742 0623799.DOC); EP 0933093 (P69742 05987654.DOC); EP 1884254 (P69742 05987654.DOC); Sauras Queteuti, “A psychotic episode after ayahuasca and secretion of Bufo Alvarius toad consumption: a case report,” 2021 (P69742 06237978.DOC); Written Opinion issued in WIPO Patent Application No. PCT/EP2023/057878, July 7, 2023 (P69742 06289659.DOC); WO2023/186826 (P69742 06238015.DOC); Written Opinion issued in WIPO Patent Application No. PCT/EP2023/057878, dated October 5, 2023 (P69742 06238015.DOC); Operating instructions for Volcano Digit (P69742 06888655.DOC); European Search Report on EP 4349407 (WO2020/169850), dated June 3, 2024 (P69742 06238017.DOC); and McCulloch, Neurosci. Biobehav. Rev., 2022, 138 (P69742 06238005.DOC).
The reference, wherein no copy was provided in that particular IDS submission but a copy was provided in a later IDS submission, are lined through in the IDS submission package wherein no copy was provided. These references are the following: C.t.A.S. Meeting, CPDD 80th Annual Scientific Meeting Program, CPDD 80th Scientific Meeting, 2018 (P69742 06237988.DOC); C.P., plc, COMPASS Pathways, plc F-1, 2020 (P69742 06237988.DOC); Office Action, issued in US Application No. 17/320,854, dated Jan 17 2025 (P69742 06491350.DOC); Third Party Submission, filed in USSN 18/373,914, dated October 4, 2024 (P69742 06491350.DOC); Office Action issued in JP 2021-575424, dated Jan 7, 2025 (P69742 06523661.DOC); ISR on WO2025/083212, dated Jan 23, 2025 (P69742 06640467.DOC); EP19158774.0 (P69742 05985869.DOC); and EP19158806.0 (P69742 05985869.DOC).
Additionally, the Third-Party Submission, submitted 1 October 2024, and the references cited therein have been considered, unless indicated otherwise.
The Examiner notes that due to the voluminous nature of the IDS submissions, there is a possibility that one or more relevant references may have been overlooked. The Examiner respectfully requests that Applicant kindly highlight the references they believe are most relevant to the claimed subject matter.
Claim Interpretation
Claim 31 recites “wherein the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score.” The Examiner interprets the Peak Experience Scale (PES) Total Score to be the Peak Psychedelic Experience Questionnaire (PPEQ) Total Score, as defined in the specification (page 70, paragraph 3).
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.
1. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws" 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025).
Lavasani teaches treating postpartum depression through natural psychedelics, such as ayahuasca (page 2, paragraph 1). The active ingredients of ayahuasca are N,N-dimethyltryptamine and 5-methoxy-N,N-dimethyltryptamine as evidenced by Halberstadt (Psychopharmacology, 2008, 201, 55-66; see IDS filed 22 Jan 2024 (P69742 05985823.DOC); abstract).
Lavasani further teaches treating severe postpartum depression with ayahuasca and that they [mothers] dreaded spending time with their newborn son and struggled to get out of bed (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3). Lavasani further specifies they [mothers] fantasized about taking their own life prior to treatment and that treating their postpartum depression with psychedelics allows them to engage in fun activities that previously felt like a chore (page 3, paragraph 3; page 3, paragraph 4).
Regarding claim 1, Lavasani teaches a method of treating a patient suffering from postpartum depression with an effective amount of 5-MeO-DMT wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
Regarding claim 2, Lavasani teaches an effective amount of 5-MeO-DMT to treat severe postpartum depression and compromised or severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
Regarding claim 3, Lavasani teaches that the patient suffers from severe depression and from severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
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.
2. Claims1-4, 5, 9-12, and 19-36 are rejected under 35 U.S.C. 103 as being unpatentable over Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws" 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025) in view of Terwey (WO 2020/169850, published 27 Aug 2020, see IDS filed 22 Jan 2024 (P69742 05987654.DOC)).
Lavasani "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws" 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025) is applied as discussed in the 35 U.S.C. 102 rejection above.
The Examiner notes the relevant teachings with respect to claims 1-3 are set forth above and are incorporated herein by reference.
Additional relevant teachings are set forth below.
Lavasani teaches treating postpartum depression through natural psychedelics, such as ayahuasca (page 2, paragraph 1).
Lavasani further teaches that their experience with ayahuasca not only helped them overcome their postpartum depression but also allowed them to reclaim their life on their own terms (page 4, paragraph 2).
Regarding claim 4, Lavasani fails to teach that the patient has a MADRS score of 20 or more.
Terwey teaches a method of treating depression and mental disorders via 5-MeO-DMT.
Terwey specifically teaches a method of treating of mental disorders, such as depression, with 5-MeO-DMT, wherein the patient has a MADRS score of 20 or more (page 33, embodiment 3).
It would have been prima facie obvious to one or ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the method of evaluating a patient’s readiness for treatment of mental disorder via 5-MeO-DMT of Terwey to develop a method of treating postpartum depression via administration of 5-MeO-DMT, to arrive at instant claim 4. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Lavasani teaches methods of treating postpartum depression through natural psychedelics, such as ayahuasca,
-Lavasani teaches motivations to investigate methods of treating moderate to severe postpartum depression via their pre-treatment suicidal ideation, post-treatment clarity, and enjoyment of activities that were previously chores,
-Terwey teaches methods of treating mental disorders, in particular major depressive disorder and anxiety disorder, via administration of 5-MeO-DMT, and
-Terwey teaches motivations to investigate treatment of mental disorders via psychoactive molecules as there is the suggestion in the art that some mental disorders are amenable for treatment with psychoactive molecules.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating postpartum depression via administration of 5-MeO-DMT, wherein the patient has a MARDS score of 20 or more.
Regarding claim 5, Terwey teaches the patient has a MADRS score of 35 or more (page 34, paragraph 4).
Regarding claim 9, Terwey teaches the patient is in remission of depressive symptoms on day 7 (page 37, embodiment 31).
Regarding claim 10, Terwey teaches a method of treating a mental disorder, wherein the patient is in remission of depressive symptoms on day 28 (page 37, embodiment 37).
Regarding claim 11, Lavasani teaches that treatment of their postpartum depression via ayahuasca (5-MeO-DMT) resulted in improved maternal functioning compared to pre-treatment (page 4, paragraph 2). Terwey then teaches the patient is in remission of depressive symptoms on day 7 (page 37, embodiment 31).
Regarding claim 12, Lavasani teaches that treatment of their postpartum depression via ayahuasca (5-MeO-DMT) resulted in improved maternal functioning compared to pre-treatment (page 4, paragraph 2). Terwey then teaches the patient is in remission of depressive symptoms on day 28 (page 37, embodiment 37).
Regarding claim 19, Terwey teaches 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience (page 34, embodiment 9).
Regarding claim 20, Terwey teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 34, embodiment 10).
Regarding claim 21, Terwey teaches a dosage of about 6 mg; or of about 12 mg; or of about 18 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (page 34, embodiment 11).
Regarding claim 22, Terwey teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (page 34, embodiment 12).
Regarding claim 23, Terwey teaches 5-MeO-DMT is administered in a dosage from about 2 mg to about 8 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 8 mg to about 14 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 14 mg to about 20 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 34, embodiment 13).
Regarding claim 24, Terwey teaches the first dosage of 5 -MeO-DMT is about 6 mg, the second dosage of 5-MeO-DMT is about 12 mg, and the third dosage of 5 -MeO-DMT is about 18 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (page 35, embodiment 14).
Regarding claim 25, Terwey teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (page 35, embodiment 15).
Regarding claim 26, Terwey teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 20, paragraph 1). Terwey further teaches use specific amounts of 5-MeO-DM: about 4 mg, about 6 mg, about 8 mg, about 10 mg, and about 12 mg (page 20, paragraph 1).
Regarding claim 27, Terwey teaches a dosage of about 6 mg; or of about 12 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 20, paragraph 1).
Regarding claim 28, Terwey teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (page 21, paragraph 1).
Regarding claim 29, Terwey teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (page 30, paragraph 3).
Regarding claim 30, Terwey teaches the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30) or is identified through achievement of at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire or is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (page 31, paragraph 2).
Regarding claim 31, Terwey teaches the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (page 31, paragraph 2).
Regarding claim 32, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation or by nasal, buccal or sublingual administration (page 24, paragraph 3).
Regarding claim 33, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 12.5 mg/l (page 24, paragraph 3). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. Terwey teaches use of 5-MeO-DMT in aerosol form for treating depression (page 24, paragraph 3). The range of the claimed invention (about 0.5 mg/l to about 18 mg/l) significantly overlaps with that of Terwey. Further, the range of the claimed invention does not provide an unexpected result in view of Terwey, who describes a method of treating mental disorders via aerosolized 5-MeO-DMT (page 24, paragraphs 3-8). Thus, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 18 mg/l.
Regarding claim 34, Terwey teaches the aerosol is generated by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, configured on a solid support, to thermal energy, and b) passing air over the thin layer to produce aerosol particle (page 24, paragraphs 5 and 8).
Regarding claim 35, Terwey teaches the dosage amount of 5-MeO-DMT or a pharmaceutically acceptable salt to be administered to the patient is inhaled with a single breath (page 25, paragraph 3).
Regarding claim 36, Terwey teaches5-MeO-DMT is used in the form of the free base (page 24, paragraph 6).
3. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws," 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025) and Terwey (WO 2020/169850, published 27 Aug 2020, see IDS filed 22 Jan 2024 (P69742 05985823.DOC)) as applied to claims 1-5, 9-12, and 19-36 above, and further in view of Barkin (J. Obstetric, Gynecologic, & Neonatal Nursing, 2014, 43(6), 792-802, see IDS filed 31 Jan 2025 (P69742 06491350.DOC)).
Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws," 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025) and Terwey (WO 2020/169850, published 27 Aug 2020, see IDS filed 22 Jan 2024 (P69742 05985823.DOC)) are applied as discussed in the 35 U.S.C. 103 rejection above.
Regarding claim 6, while the combination of Lavasani and Terwey teach methods of treating postpartum depression via administration of 5-MeO-DMT and evaluating patient mental health pre-treatment via MADRS score, they differ from that of the instantly claimed invention in that they do not explicitly teach a method of treating postpartum depression via administration of 5-MeO-DMT and evaluating patient mental health pre-treatment via Barkin Index of Maternal Functioning (BIMF).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to exemplify the methods of Lavasani and Terwey with the evaluation method of the BIMF score, as taught by Barkin to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to substitute the MADRS evaluation method of Terwey with the BIMF evaluation method of Barkin to evaluate a postpartum depression patient pre-treatment with a reasonable expectation of success, because Barkin teaches that the BIMF score was created to address that many mothers are not receptive to depression assessment and treatment due to the stigma associated with mental illness (page 2, paragraph 1). Barkin further teaches that the BIMF score was created to address the aforementioned need by employing a comprehensive, patient-centered approach with the goal of designing a measure that addressed all seven domains of maternal functioning; further, the BIMF score was viable in research and clinical settings and had favorable psychometric properties (page 3, paragraph 3). Further, Barkin teaches a patient suffering from postpartum depression with a BIMF score of 80 or below (page 5, paragraph 2). Thus, one of ordinary skill in the art would have substituted one known element for another, and the results would be predictable.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at instant claim 6: a method of treating postpartum depression via 5-MeO-DMT and evaluating patient mental health pre-treatment via BIMF score.
Regarding claim 7, Barkin teaches the compromised or severely compromised maternal functioning affects the functional domains of mother child interaction and/or management: the ability to measure the level to which the mother’s needs are being satisfied is particularly advantageous via the BIMF score, as women have described a challenge in managing infant and self-care concurrently (page 7, paragraph 3).
Regarding claim 8, Barkin teaches the scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) are not more than 60 % of the maximum score for the functional domain in Table 4 as item 12: I am taking good care of my baby’s physical needs: 53% (page 15, Table 4, Item 12).
4. Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws," 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025), Terwey (WO 2020/169850, published 27 Aug 2020, see IDS filed 22 Jan 2024 (P69742 05985823.DOC)), and Barkin (J. Obstetric, Gynecologic, & Neonatal Nursing, 2014, 43(6), 792-802, see IDS filed 31 Jan 2025 (P69742 05987654.DOC)) as applied to claims 1-12 and 19-36 above, and further in view of Deligiannidis (JAMA Psychiatry, 2021, 78(9), 951-959 and Supplemental Information).
Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws," 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025), Terwey (WO 2020/169850, published 27 Aug 2020, see IDS filed 22 Jan 2024 (P69742 05985823.DOC)), and Barkin (J. Obstetric, Gynecologic, & Neonatal Nursing, 2014, 43(6), 792-802, see IDS filed 31 Jan 2025 (P69742 05987654.DOC)) are applied as discussed in the 35 U.S.C. 103 rejection above.
Regarding claim 13, while the combination of Lavasani, Terwey, and Barkin teach methods of treating postpartum depression via administration of 5-MeO-DMT and evaluating patient mental health pre-treatment via BIMF score, they differ from that of the instantly claimed invention in that they do not explicitly teach a method of treating postpartum depression via small molecule leading to an improvement in BIMF score by at least 10 on day 7.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to exemplify the methods of Lavasani, Terwey, and Barkin with the method of evaluating small molecule treatment (e.g. zuranolone) versus placebo in postpartum depression in a clinical trial, as taught by Deligiannidis, to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to modify the post-treatment scoring of Terwey with the post-treatment scoring of Deligiannidis to evaluate small molecule treatment success in postpartum depression with a reasonable expectation of success, because Deligiannidis teaches the first Phase 3, randomized, placebo-controlled outpatient trial in women with postpartum depression, which demonstrated rapid (by day 3), clinically meaningful, and sustained (at all measured time points through day 45) antidepressant effects (page 956, column 2, paragraph 2). Deligiannidis further teaches rapid and sustained improvements in anxiety and improved global and maternal functioning compared with placebo, despite relatively high placebo response observed (page 956, column 2, paragraph 2). Further, Deligiannidis teaches BIMF LS mean change at day 8 for small molecule, zuranolone, of 12.9 points (eTable9, Supplement 2, page 11). Thus, one of ordinary skill in the art would have substituted one known element for another, and the results would be predictable.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at instant claim 13: a method of treating postpartum depression via 5-MeO-DMT and evaluating treatment success via BIMF score.
Regarding claim 14, Deligiannidis teaches the BIMF score is improved by at least 10 points (eTable9, Supplement 2, page 11).
Regarding claim 15, Deligiannidis teaches that the treatment leads to an improvement in scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) to more than 60 % of the maximum possible score (eTable9, Supplement 2, page 11). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. Deligiannidis teaches small molecule, zuranolone, was associated with clinically meaningful improvements in postpartum maternal functioning at day 45 using the patient report BIMF score (page 956, column 2, paragraph 3). The narrower range of the claimed invention does not provide an unexpected result in view of Deligiannidis, who describes a rapid treatment effect (by day 3) for postpartum depression in a randomized Phase 3 clinical trial (page 956, column 2, paragraph 2). Additionally, Terwey teaches treatment of depression with 5-MeO-DMT such that the patient is in remission on day 7 (page 37, embodiment 31). Thus, the combination of Deligiannidis and Terwey teaches that the treatment leads to an improvement in scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) on day 7 to more than 60 % of the maximum possible score.
Regarding claim 16, Deligiannidis teaches the BIMF score is improved by at least 10 % on days 8, 21, and 45 seeing improvement changes of 12.9, 19.6, and 26.9, respectively (page 956, column 2, paragraph 3; eTable 9, Supplement 2, page 11). Additionally, Terwey teaches treatment of depression with 5-MeO-DMT, such that the patient is in remission on day 28 (page 37, embodiment 37). Thus, the combination of Deligiannidis and Terwey teaches that the BIMF score is improved by at least 10% on day 28.
Regarding claim 17, Deligiannidis teaches the BIMF score is improved by at least 10 points with days 8, 21, and 45 seeing improvement changes of 12.9, 19.6, and 26.9, respectively (page 956, column 2, paragraph 3; eTable 9, Supplement 2, page 11). Additionally, Terwey teaches treatment of depression with 5-MeO-DMT such that the patient is in remission on day 28 (page 37, embodiment 37). Thus, the combination of Deligiannidis and Terwey teaches that the BIMF score is improved by at least 10 points on day 28.
Regarding claim 18, Deligiannidis teaches that the treatment leads to an improvement in scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) to more than 60 % of the maximum possible score (eTable9, Supplement 2, page 11). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. Deligiannidis teaches small molecule, zuranolone, was associated with clinically meaningful improvements in postpartum maternal functioning at day 45 using the patient report BIMF score (page 956, column 2, paragraph 3). The narrower range of the claimed invention does not provide an unexpected result in view of Deligiannidis, who describes a rapid treatment effect (by day 3) for postpartum depression in a randomized Phase 3 clinical trial (page 956, column 2, paragraph 2). Additionally, Terwey teaches treatment of depression with 5-MeO-DMT such that the patient is in remission on day 28 (page 37, embodiment 37). Thus, the combination of Deligiannidis and Terwey teaches that the treatment leads to an improvement in scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) on day 28 to more than 60 % of the maximum possible score.
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.
5. Claims 1-5, 9-12, and 19-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 69-85 of copending Application No. 18/373,906 (published as U.S. Publication No. 2024/0108602) in view of Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws," 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025) and Terwey (WO 2020/169850, published 27 Aug 2020; see IDS filed 22 Jan 2024 (P69742 05987654.DOC)). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/373,906 claims a method of treating a mental or nervous system disorder in a breastfeeding mother, comprising administering an effective amount of 5-MeO-DMT via a dosage of about 4 mg to about 20 mg of 5-MeO-DMT as a single dose or the highest dose in an uptitration scheme involving intervals between administrations of at least 1 hour (claims 1-5, 9-12, and 19-36).
Regarding claim 1, ‘906 fails to teach that the patient has postpartum depression.
Lavasani teaches treating postpartum depression through natural psychedelics, such as ayahuasca (page 2, paragraph 1). The active ingredients of ayahuasca are N,N-dimethyltryptamine and 5-methoxy-N,N-dimethyltryptamine as evidenced by Halberstadt (Psychopharmacology, 2008, 201, 55-66; see IDS filed 22 Jan 2024 (P69742 05985823.DOC); abstract). Thus, Lavasani teaches a method of treating a patient suffering from postpartum depression with an effective amount of 5-MeO-DMT wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
Lavasani further teaches that their experience with ayahuasca not only helped them overcome their postpartum depression but also allowed them to reclaim their life on their own terms (page 4, paragraph 2).
It would have been prima facie obvious to one or ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the method of treating postpartum depression via 5-MeO-DMT of Lavasani and the method of treating a mental disorder and dosing of ‘906 to develop a method of treating postpartum depression via administration of 5-MeO-DMT, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘906 teaches a method of treating mental disorders in breastfeeding mothers via psychedelics,
-‘906 teaches dosing regimens for psychoactive therapies with better safety profiles,
-Lavasani teaches methods of treating postpartum depression through natural psychedelics, such as ayahuasca, and
-Lavasani teaches motivations to investigate methods of treating moderate to severe postpartum depression via their pre-treatment suicidal ideation, post-treatment clarity, and enjoyment of activities that were previously chores.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating postpartum depression via administration of 5-MeO-DMT.
Regarding claim 2, ‘906 teaches an effective amount of 5-MeO-DMT to treat postpartum depression (claim 1 of ‘906).
Regarding claim 3, Lavasani teaches that the patient suffers from severe depression and from severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
Regarding claim 4, while the combination of ‘906 and Lavasani teach a method of treating postpartum depression via administration of 5-MeO-DMT, they differ from that of the instantly claimed invention in that they do not explicitly teach a method of treating postpartum depression via administration of 5-MeO-DMT and then evaluating patient mental health pre-treatment via MADRS score.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to exemplify the methods of ‘906 and Lavasani with the evaluation method of the MADRS score, as taught by Terwey (WO 2020/169850, published 27 Aug 2020; see IDS filed 22 Jan 2024 (P69742 05987654.DOC)) to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to substitute the HAM-D evaluation method of ‘906 with the MADRS evaluation method of Terwey to evaluate a postpartum depression patient pre-treatment with a reasonable expectation of success, because Terwey teaches a method of treating depression and mental disorders via 5-MeO-DMT. Terwey teaches motivations to investigate treatment of mental disorders via psychoactive molecules as there is the suggestion in the art that some mental disorders are amenable for treatment with psychoactive molecules fail to teach that the patient has a MADRS score of 20 or more. Thus, one of ordinary skill in the art would have substituted one known element for another, and the results would be predictable.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating postpartum depression via administration of 5-MeO-DMT, wherein the patient has a MARDS score of 20 or more.
Regarding claim 5, Terwey teaches the patient has a MADRS score of 35 or more (page 34, paragraph 4).
Regarding claim 9, Terwey teaches the patient is in remission of depressive symptoms on day 7 (page 37, embodiment 31).
Regarding claim 10, Terwey teaches a method of treating a mental disorder, wherein the patient is in remission of depressive symptoms on day 28 (page 37, embodiment 37).
Regarding claim 11, Lavasani teaches that treatment of their postpartum depression via ayahuasca (5-MeO-DMT) resulted in improved maternal functioning compared to pre-treatment (page 4, paragraph 2). Terwey then teaches the patient is in remission of depressive symptoms on day 7 (page 37, embodiment 31).
Regarding claim 12, Lavasani teaches that treatment of their postpartum depression via ayahuasca (5-MeO-DMT) resulted in improved maternal functioning compared to pre-treatment (page 4, paragraph 2). Terwey then teaches the patient is in remission of depressive symptoms on day 28 (page 37, embodiment 37).
Regarding claim 19, Terwey teaches 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience (page 34, embodiment 9).
Regarding claim 20, ‘906 teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (claim 1 of ‘906).
Regarding claim 21, ‘906 teaches a dosage of about 6 mg; or of about 12 mg; or of about 18 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (claim 70 of ‘906).
Regarding claim 22, ‘906 teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (claim 71 of ‘906).
Regarding claim 23, ‘906 teaches 5-MeO-DMT is administered in a dosage from about 2 mg to about 8 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 8 mg to about 14 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 14 mg to about 20 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (claim 72 of ‘906).
Regarding claim 24, ‘906 teaches the first dosage of 5 -MeO-DMT is about 6 mg, the second dosage of 5-MeO-DMT is about 12 mg, and the third dosage of 5 -MeO-DMT is about 18 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (claim 73 of ‘906).
Regarding claim 25, ‘906 teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (claim 74 of ‘906).
Regarding claim 26, ‘906 teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (claim 75 of ‘906).
Regarding claim 27, ‘906 teaches a dosage of about 6 mg; or of about 12 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (claim 76 of ‘906).
Regarding claim 28, ‘906 teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (claim 77 of ‘906).
Regarding claim 29, ‘906 teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (claim 78 of ‘906).
Regarding claim 30, ‘906 teaches the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30) or is identified through achievement of at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire or is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (claim 79 of ‘906).
Regarding claim 31, ‘906 teaches the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (claim 80 of ‘906).
Regarding claim 32, ‘906 teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation or by nasal, buccal or sublingual administration (claim 81 of ‘906).
Regarding claim 33, ‘906 teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 12.5 mg/l (claim 82 of ‘906).
Regarding claim 34, ‘906 teaches the aerosol is generated by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, configured on a solid support, to thermal energy, and b) passing air over the thin layer to produce aerosol particle (claim 83 of ‘906).
Regarding claim 35, ‘906 teaches the dosage amount of 5-MeO-DMT or a pharmaceutically acceptable salt to be administered to the patient is inhaled with a single breath (claim 84 of ‘906).
Regarding claim 36, ‘906 teaches 5-MeO-DMT is used in the form of the free base (claim 85 of ‘906).
6. Claims 1-5, 9-12, and 19-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 49, and 69-87 of copending Application No. 18/373,914 (published as U.S. Publication No. 2024/0115550) in view of Lavasani, "Psychedelics Helped Me Reclaim My Life and Push to Change Drug Laws," 2020, Petri-Flom Center: Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, petrieflom.law.harvard.edu/2020/10/28/decriminalize-nature-dc-initiative-81/, accessed 10 Dec 2025) and Terwey (WO 2020/169850, published 27 Aug 2020; see IDS filed 22 Jan 2024 (P69742 05987654.DOC)). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/373,914 claims a method of treating a mental or nervous system disorder in a breastfeeding mother, comprising administering an effective amount of 5-MeO-DMT via a dosage of about 4 mg to about 20 mg of 5-MeO-DMT as a single dose or the highest dose in an uptitration scheme involving intervals between administrations of at least 1 hour and the patient is advised to temporarily cease breastfeeding (claims 1-5, 9-12, and 19-36).
Regarding claim 1, ‘914 teaches that the patient has postpartum depression (claim 49 of ‘914).
Regarding claim 2, ‘914 fails to teach that the patient suffers from compromised or severely compromised maternal functioning.
Lavasani teaches treating postpartum depression through natural psychedelics, such as ayahuasca (page 2, paragraph 1). The active ingredients of ayahuasca are N,N-dimethyltryptamine and 5-methoxy-N,N-dimethyltryptamine as evidenced by Halberstadt (Psychopharmacology, 2008, 201, 55-66; see IDS filed 22 Jan 2024; abstract). Thus, Lavasani teaches a method of treating a patient suffering from postpartum depression with an effective amount of 5-MeO-DMT wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
Lavasani further teaches that their experience with ayahuasca not only helped them overcome their postpartum depression but also allowed them to reclaim their life on their own terms (page 4, paragraph 2).
It would have been prima facie obvious to one or ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the method of treating postpartum depression with compromised or severely compromised maternal functioning via 5-MeO-DMT of Lavasani and the method of treating a mental disorder and dosing of ‘914 to develop a method of treating postpartum depression via administration of 5-MeO-DMT, to arrive at instant claim 2. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘914 teaches a method of treating mental disorders in breastfeeding mothers via psychedelics,
-‘914 teaches dosing regimens for psychoactive therapies with better safety profiles,
-Lavasani teaches methods of treating postpartum depression through natural psychedelics, such as ayahuasca, and
-Lavasani teaches motivations to investigate methods of treating moderate to severe postpartum depression via their pre-treatment suicidal ideation, post-treatment clarity, and enjoyment of activities that were previously chores.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating postpartum depression with compromised or severely compromised maternal functioning via administration of 5-MeO-DMT.
Regarding claim 3, Lavasani teaches that the patient suffers from severe depression and from severely compromised maternal functioning (page 2, paragraph 3; page 3, paragraph 1; page 3, paragraph 3; page 3, paragraph 4).
Regarding claim 4, while the combination of ‘914 and Lavasani teach a method of treating postpartum depression via administration of 5-MeO-DMT, they differ from that of the instantly claimed invention in that they do not explicitly teach a method of treating postpartum depression via administration of 5-MeO-DMT and then evaluating patient mental health pre-treatment via MADRS score.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to exemplify the methods of ‘914 and Lavasani with the evaluation method of the MADRS score, as taught by Terwey (WO 2020/169850, published 27 Aug 2020; see IDS filed 22 Jan 2024 (P69742 05987654.DOC)) to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to substitute the HAM-D evaluation method of ‘914 with the MADRS evaluation method of Terwey to evaluate a postpartum depression patient pre-treatment with a reasonable expectation of success, because Terwey teaches a method of treating depression and mental disorders via 5-MeO-DMT. Terwey teaches motivations to investigate treatment of mental disorders via psychoactive molecules as there is the suggestion in the art that some mental disorders are amenable for treatment with psychoactive molecules. Thus, one of ordinary skill in the art would have substituted one known element for another, and the results would be predictable.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating postpartum depression via administration of 5-MeO-DMT, wherein the patient has a MARDS score of 20 or more.
Regarding claim 5, Terwey teaches the patient has a MADRS score of 35 or more (page 34, paragraph 4).
Regarding claim 9, Terwey teaches the patient is in remission of depressive symptoms on day 7 (page 37, embodiment 31).
Regarding claim 10, Terwey teaches a method of treating a mental disorder, wherein the patient is in remission of depressive symptoms on day 28 (page 37, embodiment 37).
Regarding claim 11, Lavasani teaches that treatment of their postpartum depression via ayahuasca (5-MeO-DMT) resulted in improved maternal functioning compared to pre-treatment (page 4, paragraph 2). Terwey then teaches the patient is in remission of depressive symptoms on day 7 (page 37, embodiment 31).
Regarding claim 12, Lavasani teaches that treatment of their postpartum depression via ayahuasca (5-MeO-DMT) resulted in improved maternal functioning compared to pre-treatment (page 4, paragraph 2). Terwey then teaches the patient is in remission of depressive symptoms on day 28 (page 37, embodiment 37).
Regarding claim 19, Terwey teaches 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience (page 34, embodiment 9).
Regarding claim 20, ‘914 teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (claim 1 of ‘914).
Regarding claim 21, Terwey teaches a dosage of about 6 mg; or of about 12 mg; or of about 18 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (page 34, embodiment 11).
Regarding claim 22, ‘914 teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (claim 73).
Regarding claim 23, Terwey teaches 5-MeO-DMT is administered in a dosage from about 2 mg to about 8 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 8 mg to about 14 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 14 mg to about 20 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 34, embodiment 13).
Regarding claim 24, Terwey teaches the first dosage of 5 -MeO-DMT is about 6 mg, the second dosage of 5-MeO-DMT is about 12 mg, and the third dosage of 5 -MeO-DMT is about 18 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (page 35, embodiment 14).
Regarding claim 25, ‘914 teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (claim 80 of ‘914).
Regarding claim 26, Terwey teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 20, paragraph 1). Terwey further teaches use specific amounts of 5-MeO-DM: about 4 mg, about 6 mg, about 8 mg, about 10 mg, and about 12 mg (page 20, paragraph 1).
Regarding claim 27, Terwey teaches a dosage of about 6 mg; or of about 12 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 20, paragraph 1).
Regarding claim 28, Terwey teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (page 21, paragraph 1).
Regarding claim 29, Terwey teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (page 30, paragraph 3).
Regarding claim 30, ‘914 teaches the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30) or is identified through achievement of at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire or is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (claim 85 of ‘914).
Regarding claim 31, ‘814 teaches the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (claim 86 of ‘914).
Regarding claim 32, ‘814 teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation or by nasal, buccal or sublingual administration (claim 1 of ‘914).
Regarding claim 33, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 12.5 mg/l (page 24, paragraph 3). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. Terwey teaches use of 5-MeO-DMT in aerosol form for treating depression (page 24, paragraph 3). The range of the claimed invention significantly overlaps with that of Terwey. Further, the range of the claimed invention does not provide an unexpected result in view of Terwey, who describes a method of treating mental disorders via aerosolized 5-MeO-DMT (page 24, paragraphs 3-8). Thus, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 18 mg/l.
Regarding claim 34, Terwey teaches the aerosol is generated by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, configured on a solid support, to thermal energy, and b) passing air over the thin layer to produce aerosol particle (page 24, paragraphs 5 and 8).
Regarding claim 35, Terwey teaches the dosage amount of 5-MeO-DMT or a pharmaceutically acceptable salt to be administered to the patient is inhaled with a single breath (page 25, paragraph 3).
Regarding claim 36, Terwey teaches 5-MeO-DMT is used in the form of the free base (page 24, paragraph 6).
7. Claims 1-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-37 of copending Application No. 18/373,904 (published as U.S. Publication No. 2024/0115549) in view of Terwey (WO 2020/169850, published 27 Aug 2020; see IDS filed 22 Jan 2024 (P69742 05987654.DOC)). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/373,904 claims a method of treating a postpartum depression, comprising administering an effective amount of 5-MeO-DMT, and treatment is administered via intravenous, intramuscular, or subcutaneous route (claims 1-36).
Regarding claim 1, ‘904 teaches a method of treating a patient suffering from moderate to severe depression and from compromised or severely compromised maternal functioning via 5-MeO-DMT (claim 1 of ‘904).
Regarding claim 2, ‘904 teaches that the patient suffers from compromised or severely compromised maternal functioning (claim 2 of ‘904).
Regarding claim 3, ‘904 teaches that the patient suffers from severe depression and from severely compromised maternal functioning claim 3 of ‘904).
Regarding claim 4, ‘904 teaches the patient has a MADRS score of 20 or more (claim 4 of ‘904).
Regarding claim 5, ‘904 teaches the patient has a MADRS score of 35 or more (claim 5 of ‘904).
Regarding claim 6, ‘904 teaches a method of treating postpartum depression via 5-MeO-DMT and evaluating patient mental health pre-treatment via BIMF score (claim 6 of ‘904).
Regarding claim 7, ‘904 teaches the compromised or severely compromised maternal functioning affects the functional domains of mother child interaction and/or management (claim 7 of ‘904).
Regarding claim 8, ‘904 teaches the scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) are not more than 60 % of the maximum score for the functional domain (claim 8 of ‘904).
Regarding claim 9, ‘904 teaches the patient is in remission of depressive symptoms on day 7 (claim 9 of ‘904).
Regarding claim 10, ‘904 teaches a method of treating a mental disorder, wherein the patient is in remission of depressive symptoms on day 28 (claim 10 of ‘904).
Regarding claim 11, ‘904 teaches that maternal functioning is improved as compared to pre-treatment functioning on day 7 (claim 11 of ‘904).
Regarding claim 12, ‘904 teaches that maternal functioning is improved, compared to pre-treatment functioning on day 28 (claim 12 of ‘904).
Regarding claim 13, ‘904 teaches a method of treating postpartum depression via 5-MeO-DMT and evaluating treatment success via BIMF score (claim 13 of ‘904).
Regarding claim 14, ‘904 teaches the BIMF score is improved by at least 10 points (claim 14 of ‘904).
Regarding claim 15, ‘904 teaches the treatment leads to an improvement in scores assigned to the functional domains of mother child interaction and/or management according to the Barkin Index of Maternal Functioning (BIMF) on day 7 to more than 60 % of the maximum possible score (claim 15 of ‘904).
Regarding claim 16, ‘904 teaches the BIMF score is improved by at least 10% on day 28 (claim 16 of ‘904).
Regarding claim 17, ‘904 teaches the BIMF score is improved by at least 10 points on day 28 (claim 17 of ‘904).
Regarding claim 18, ‘904 teaches the BIMF score is improved by at least 10 points on day 28 (claim 18 of ‘904).
Regarding claim 19, ‘904 teaches 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience (claim 19 of ‘904).
Regarding claim 20, ‘904 fails to teach a method of treating postpartum depression in dosages of 4 to 20 mg of 5-MeO-DMT.
Terwey teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 34, embodiment 10).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to exemplify the methods of ‘904 with the dosages, as taught by Terwey (WO 2020/169850, published 27 Aug 2020; see IDS filed 22 Jan 2024 (P69742 05987654.DOC)) to arrive at the instantly claimed invention.
One of ordinary skill in the art would have been motivated to substitute the dosages of ‘904 with the dosages of Terwey with a reasonable expectation of success, because Terwey teaches a method of treating depression and mental disorders via 5-MeO-DMT. Terwey teaches motivations to investigate treatment of mental disorders via psychoactive molecules as there is the suggestion in the art that some mental disorders are amenable for treatment with psychoactive molecules (page 1, paragraph 2). Thus, one of ordinary skill in the art would have substituted one known element for another, and the results would be predictable.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating postpartum depression via administration of 5-MeO-DMT in a range of about 4 mg to about 20 mg.
Regarding claim 21, Terwey teaches a dosage of about 6 mg; or of about 12 mg; or of about 18 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (page 34, embodiment 11).
Regarding claim 22, ‘904 teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (claim 24 of ‘904).
Regarding claim 23, Terwey teaches 5-MeO-DMT is administered in a dosage from about 2 mg to about 8 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 8 mg to about 14 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 14 mg to about 20 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 34, embodiment 13).
Regarding claim 24, Terwey teaches the first dosage of 5 -MeO-DMT is about 6 mg, the second dosage of 5-MeO-DMT is about 12 mg, and the third dosage of 5 -MeO-DMT is about 18 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5 -MeO-DMT (page 35, embodiment 14).
Regarding claim 25, ‘904 teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (claim 31 of ‘904).
Regarding claim 26, Terwey teaches a dosage of about 4 mg to about 20 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 20, paragraph 1). Terwey further teaches use specific amounts of 5-MeO-DM: about 4 mg, about 6 mg, about 8 mg, about 10 mg, and about 12 mg (page 20, paragraph 1).
Regarding claim 27, Terwey teaches a dosage of about 6 mg; or of about 12 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT (page 20, paragraph 1).
Regarding claim 28, Terwey teaches 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5 -MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience (page 21, paragraph 1).
Regarding claim 29, Terwey teaches the interval between two administrations is not less than 1 hour and not more than 24 hours (page 30, paragraph 3).
Regarding claim 30, ‘904 teaches the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30) or is identified through achievement of at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire or is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (claim 36 of ‘904).
Regarding claim 31, ‘904 teaches the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 (claim 37 of ‘904).
Regarding claim 32, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation or by nasal, buccal or sublingual administration (page 24, paragraph 3).
Regarding claim 33, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 12.5 mg/l (page 24, paragraph 3). A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. Terwey teaches use of 5-MeO-DMT in aerosol form for treating depression (page 24, paragraph 3). The range of the claimed invention significantly overlaps with that of Terwey. Further, the range of the claimed invention does not provide an unexpected result in view of Terwey, who describes a method of treating mental disorders via aerosolized 5-MeO-DMT (page 24, paragraphs 3-8). Thus, Terwey teaches 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in the form of an aerosol comprising (a) a pharmaceutically acceptable gas; (b) aerosol particles of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the aerosol has an aerosol particle mass density of about 0.5 mg/I to about 18 mg/l.
Regarding claim 34, Terwey teaches the aerosol is generated by a) exposing a thin layer of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, configured on a solid support, to thermal energy, and b) passing air over the thin layer to produce aerosol particle (page 24, paragraphs 5 and 8).
Regarding claim 35, Terwey teaches the dosage amount of 5-MeO-DMT or a pharmaceutically acceptable salt to be administered to the patient is inhaled with a single breath (page 25, paragraph 3).
Regarding claim 36, Terwey teaches 5-MeO-DMT is used in the form of the free base (page 24, paragraph 6).
Conclusion
No claim is allowed.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622