DETAILED ACTION
This action is in response to papers filed on 01/30/2026. Claims 31-50 of Obidin et al., 18605819 (03/15/2024) are pending examination on the merits: claims 31-40, and 42-46 are amended. Claims 31-50 are rejected. Applicant is advised that going forward a different Examiner will handle the prosecution of the instant application. See signatures/initials at end of this office action.
Notice of Pre-AIA or AIA Status
The present applica5tion, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a CON of 18/230,142 filed on 08/03/2023 PAT 11,939,312 which is a CON of PCT/US22/32275 filed on 06/03/2022 which claims benefit of 63/196,226 filed on 06/03/2021.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/30/2026 has been entered.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 02/19/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Withdrawn Rejections
The rejection of claims 31-50 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30, of U.S. Patent No. 11,939,312 is withdrawn in view of the Terminal Disclaimer filed on 01/31/2026. Applicant’s Remarks at page 10.
Modified Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 42-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed ratio is the critical element of the invention. It lacks adequate support in the specification. Like the other claims, claims 40 and 46, cover a range beyond 9:1. Only a ratio of 9:1, see figure 6, is tested. But it does not relate to any particular disorder much less the disorders in claim 47. There is no nexus between the ratio and each disorder in claim 47. The claims are deemed speculative.
“Failure of patent applicants to provide basis for believing speculative statements placed in the specification as positive assertion is true, and failing such, ignorance of PTO in not being able to provide scientific reason why assertion is not sound is not justification for permitting assertion to be made, where those of ordinary skill in the art would not accept assertion as believable without some data or other evidence to support it.” In re Hozumi, 226 USPQ 353, (ComrPats, 1985). “Proof of utility is sufficient if it is convincing to one [of] ordinary skill in the art, amount of evidence required depends on facts of each individual case, character and amount of evidence needed may vary, depending on whether alleged utility appears to accord with or to contravene scientific principles and beliefs.” In re Jolles, 206 USPQ 885 (CCPA, 1980).
Response
Applicant’s arguments filed on 01/30/2026 have been fully considered but they are not persuasive. Applicant argues that independent claims 31, 36, and 42, which previously recited a non-racemic mixture of R-MDMA and S-MDMA in a molar ratio of “between about 4:1 and about 12:1,” now recite only a mixture comprising “about 9:1. The rejection has been modified in view of the amendments to the composition claims (c.f., claims 31-41). However, as previously stated, in figure 6 of the Specification, only a ratio of 9:1 is tested, but it does not relate to any particular disorder much less the disorders in claims 42-50. Therefore, the methods of use claims are deemed expected outcomes/results, after the appropriate specific ratio for each composition is ascertained and administered. Expected outcome is not given patentable weight in a method claim, wherein the step is not yet performed. In re Minton, 67 USPQ2D 1614, 1620 (Fed Cir, 2003). Method claims may be canceled to overcome the rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 42-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
[In re Sichert, 196 USPQ 209 (CCPA 1977)]
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
The nature of the invention & breadth of the claims: The claims are directed to generic methods of treating a multitude of mental health disorders, encompassing hundreds of disorders, along with those disclosed in claims 47-50, by administering a composition comprising a non-racemic mixture of R-, and S-MDMA in a ratio of about 9:1 ratio. Claim 47 also discloses, for example, “other binge behavior”, “avoidant” disorder, “narcissistic” disorder, autism spectrum disorder as some of the many forms of mental health disorders allegedly treatable by the claimed compositions, which is broad. Applicant’s specification is largely directed to the synthesis of the claimed compounds, but not to methods of treating the multitude of mental health disorders, encompassing hundreds of disorders in a subject by administering an effective amount of the claimed compositions in a ratio of about 9:1. The claims are therefore very broad as they are directed to the treatment of a multitude of mental health disorders with various pathologies, without being reasonably enabling.
The state of the prior art: However, the state of the art recognizes many of these mental health disorders, but does not link any emerging treatments with MDMA, for example, in the treatment of autism spectrum disorder (ASD). Kaye et al., Emerging Treatments and Therapies for Autism Spectrum Disorder: A Narrative Review. Cureus. 2024 Jul 2;16(7):e63671, teaches emerging treatments and therapies for autism spectrum disorder. Kaye et al teaches that “Although ASD does not have a cure, there are several management options available that can help reduce symptom severity.”. MDMA was not listed. Kaye discusses current literature involving novel pharmacological treatments such as oxytocin, bumetanide, acetylcholinesterase inhibitors, and memantine. It also discusses additional therapies such as diet intervention, acupuncture, music therapy, melatonin, and the use of technology to aid education. (Abstract).
Regarding premenstrual dysphoric disorder, emerging evidence included selective serotonin reuptake inhibitors, oral contraceptives, leuprolide (i.e., a gonadotrophin releasing hormone agonist), and an allopregnanolone antagonist as discussed by Carlini et al., Evidence-Based Treatment of Premenstrual Dysphoric Disorder: A Concise Review. J Clin Psychiatry. 2020 Feb 4;81(2):19ac13071.
Post-traumatic stress disorder (PTSD) is also addressed in the prior art as another complex mental health disorder that “In cases of confirmed PTSD, or clinically important symptoms of PTSD, NICE recommends eight to twelve 90-min sessions of individual Trauma-Focused CBT (TF-CBT), within which Cognitive Processing Therapy, Cognitive Therapy for PTSD, Narrative Exposure Therapy (NET), and Prolonged Exposure therapy are included. NICE also supports the use of Eye Movement Desensitization and Reprocessing (EMDR) therapy if this is the client’s preference, although notably NICE currently does not recommend EMDR for combat-related trauma…” as taught by Billings et al., PTSD and complex PTSD, current treatments and debates: a review of reviews, British Medical Bulletin, Volume 156, Issue 1, December 2025, ldaf015.
Regarding Major depressive disorder, “Major depressive disorder (MDD) affects a substantial portion of the population; however, much is still unknown about the pathophysiology of this disorder. Treatment resistance highlights the heterogeneous nature of MDD and the need for treatments to target more than monoamine neurotransmission. This review summarizes research into the new and emerging targets of MDD. These include drugs such as psychedelics, antibiotics, opioid modulators, neuropeptides, and onabotulinumtoxin. Neuromodulatory treatments such as light-based therapies and neuromodulation involving either magnetic or electrical stimulation are also discussed. Almost all interventions, pharmacological and neuromodulation, were trialed as adjunctive treatments to an antidepressant. Most research has been conducted on psychedelics, with trials suggesting rapid antidepressant and anti-suicidal effects. Trial findings, tolerability, study design limitations and quality of research have been considered throughout this review. There remain challenges in forming recommendations with the current research at present. With there being considerable interest into the research of new and emerging treatments—in particular, psychedelics.” Njenga et al., BMJ 2024;386:e073823.
It is clear from the state of the art, that there is not any one single treatment or compound that cures essentially all mental health. In addition to that, nothing in the prior art points to MDMA curing the claimed mental health disorders including narcissistic disorder, avoidant disorder, “other binge behavior”, PTSD, MDD, or any of the claimed mental health, and the Specification does not reasonably provide enablement for these limitations.
The level of the skill in the art & The predictability in the art: The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner contends that the term mental health encompasses various type of mental health disorders and yet applicant failed to provide enablement for a method of treating the claimed disorders utilizing the claimed composition. Further, the predictability of treating PTSD, and many other personality disorders such as avoidant disorder or narcissistic disorder using MDMA, is relatively low.
One skilled in the art would not reasonably expect that one agent (i.e., the claimed MDMA composition) would be effective in treating essentially all mental health.
Thus, given that applicant has failed to demonstrate treatment of the claimed mental health disorders utilizing the claimed composition and in light of the challenge in treating various types of mental health disorders, such as ASD, and MDD, the examiner maintains that applicant has not enabled the breadth of the claims. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. They have not shown a nexus to treat diseases but have provided only reports in vitro which, absent a correlation to treat of diseases, are not sufficient to enable the invention.
The quantity of experimentation necessary, the amount of direction or guidance provided, the presence or absence of working examples: The amount of guidance or direction needed to enable the invention is inversely related to the degree of predictability in the art. In re Fisher, 839, 166 USPQ 24. Thus, although a single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements, in cases involving unpredictable factors, such as most chemical reactions and physiological activity, more teaching or guidance is required. In re Fisher, 427 F.2d 839, 166 USPQ 24; Ex Parte Hitzeman, 9 USPQ 2d 1823. For example, the Federal Circuit determined that, given the unpredictability of the physiological activity of RNA viruses, a specification requires more than a general description and a single embodiment to provide an enabling disclosure for a method of protecting an organism against RNA viruses. In re Wright, 999 F.2d 1562-63, 27 USPQ2d 1575.
Regarding the Specification guidance, methods of treatment are introduced in para. [0248], mental health disorders are listed in paras. [0251]-[0257], generalized citations of: substance abuse disorders are discussed in para. [0264], opioids abuse in para. [0266], nicotine dependence and tobacco use disorder [0269], stimulant use disorder in para [0273], etc., are discussed throughout the disclosure, along with generalized methods of administration in para. [0278]. Applicant’s Specification essentially concludes in general in para. [0335]: “The potential side effects seen in the literature with racemic MDMA are expected to be absent or reduced in response to administration of 9:1 R:S-MDMA. The potential risk of a study participant being severely agitated, anxious or depressed is low. The enantiomeric mixture is expected to produce a slight increase in body temperature, if any, no risk of osmoregulatory changes. Following completion of the Phase I study, the safety profile of R- MDMA HCl and S-MDMA in a 9:1 ratio will be assessed and dose selection will be performed. If no serious adverse incidents are observed, the optimal dose will be selected for the Phase II trial.”. As it relates to the method claims for the treatment of mental health disorders, the Specification is speculative and not enabling the claimed invention.
Because of the known unpredictability of the art, and in the absence of experimental evidence to support the claimed mental health disorders, especially with no clear clinical nexus between MDMA and the treatment of all the claimed diseases, no one skilled in the art would accept the assertion that every instantly claimed composition could be predictably used for the treatment of all mental health disorders in a subject inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success. One of ordinary skill in the art, even with high level of skill, is unable to use the instant compounds as claimed without undue experimentation. As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”. Claims 42-50 are rejected.
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 31-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 216-221 and 227-234 of copending Application No. 18/577,183 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claim 216 recites:
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With the same claimed molar ratio amounts as the claimed invention (c.f., claim 221), and the claimed diseases in claim 231. The difference between the reference application and the claimed invention is the recitation of (b) a hallucinogenic agent. However, the comprising language of the instant invention does not preclude the incorporation of a hallucinogenic agent. Thus, the claims are not patentably distinct from each other, are obvious, and overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art
This application is a CON of 18/230,142 filed on 08/03/2023 PAT 11,939,312 (“’312”). A Terminal Disclaimer was approved on 01/31/2026.
The closest prior art is Stamets et al., US PG-PUB 2021/0069170 A1 published on March 11, 2021. A Third-Party Submission was included in Applicant’s IDS filed on 02/19/2026, citing Stamets, for the parent application 18/230,142 filed on 08/03/2023 PAT 11,939,312.
Stamets teaches tryptamine compositions for enhancing neurite outgrowth (title). Stamets teaches MDMA in para. [0224], and discusses a similar ratio to the claimed ratio in para. [0090], along with treatment of cognitive disorders in para. [0057]; however, Stamets does not describe MDMA with sufficient specificity to enable or render obvious a non-racemic R/S-MDMA mixture, at the defined molar ratio, with independently selected pharmaceutical salts. Furthermore, Stamets lacks MDMA enantiomer-specific teachings, while the instant claims require R-MDMA and S-MDMA in a defined non-racemic ratio. There’s no emphasis on enantiomeric mixtures or ratios, which is materially different from a general racemic or unspecified mixture as taught in Stamets. There’s also no motivation or direction toward the claimed composition. In other words, Stamets does not teach or provide a reason to combine R-, and S-MDMA in a specific ratio to arrive at the claimed invention with reasonable expectation of success.
Conclusion
Claims 31-50 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANTAL ADLAM whose telephone number is (571)270-0923. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/C A/Examiner, Art Unit 1622 March 31, 2026
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622