DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/14/2025 has been entered.
Claim Status
Applicants' response and amendments to the claims, filed 11/14/2025, are acknowledged and entered. No claims were cancelled or newly added.
Claims 9-11, 13-15, 17-18, 20, 25, 30, and 36-37 are pending and under examination.
Information Disclosure Statement
Applicant’s Information Disclosure Statement filed 11/14/2025 has been received and entered into the present application. As reflected by the attached, completed copy of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
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 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 9-11, 17-18, 20, 25, 30, and 36-37
Claims 9-11, 17-18, 20, 25, 30, and 36-37 are rejected under 35 U.S.C. 103(a) as being unpatentable over DANFORTH ET AL. (Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2016, vol. 64, p.237-249) (hereinafter “Danforth 2016”), DANFORTH ET AL. (Psychopharmacology, 2018, vol. 235, p.3137-3148) (hereinafter “Danforth 2018”), CURRY ET AL. (Neuropharmacology, 2018, vol. 128, p.196-206) and PITTS ET AL. (Psychopharmacology, 2018, vol. 235, p.377-392) in view of HYSEK ET AL. (Journal of Clinical Psychopharmacology, 2013, 33(5), p.658-666), BOUSO ("Using MDMA in the treatment of post-traumatic stress disorder" in Julie Holland (Ed.), Ecstasy: The Complete Guide: A Comprehensive Look at the Risks and Benefits of MDMA. 2001:248-260), and GREER ET AL. (Journal of Psychoactive Drugs, 1998, 30(4), p.371-379).
The amended claims recite methods of treating autism spectrum disorder in an individual that include a step of administering an oral dosage form of a composition comprising an R(-) enantiomer of MDMA or MDA, and wherein the method is not an adjunct to psychotherapy. See independent Claim 9.
DANFORTH 2016 teach MDMA-assisted therapy as a new treatment model for social anxiety in autistic adults (Title; Abstract). They teach ample anecdotal data regarding the MDMA/Ecstasy experiences of autistic individuals available through spontaneous, first-person accounts posted in online discussion forums provided foundational support for clinical research on MDMA-assisted therapy for social anxiety with autistic adults (p.243, right column, first full paragraph). They teach for the present FDA-compliant, IRB-approved pilot investigation of the effects of MDMA-assisted therapy on social anxiety in autistic adults, a placebo-controlled, double-blind methodology is being employed, utilizing an MDMA dosage in the range of 75 mg–125 mg (p.244, left column, second full paragraph).
DANFORTH 2018 report on the findings of the MDMA-assisted therapy for social anxiety in autistic adults study first taught in Danforth 2016. They teach autistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) or inactive placebo (0 mg, n = 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting (Abstract). Improvement in Leibowitz Social Anxiety Scale (LSAS) scores from baseline to the primary endpoint was significantly greater for MDMA group
compared to the placebo group (P = 0.037) (Id.). Regarding administering an “oral dosage form of a composition comprising the R(-)-enantiomer of MDMA”, e.g., a capsule as recited in Claim 18, they teach MDMA was synthesized by David Nichols at Purdue University, compounded with lactose, and placed into gelatin capsules by a research pharmacist (p.3138, left column, first full paragraph).
CURRY ET AL. teach S,R(+/-)-3,4-methylenedioxymethamphetamine (SR-MDMA) is an amphetamine derivative with pro-social and putative therapeutic effects and that ongoing clinical trials are investigating it as a treatment for PTSD and other conditions. They teach its potential adverse effects such as hyperthermia and neurotoxicity may limit its clinical viability. They hypothesized that R-MDMA would retain prosocial and therapeutic effects but with fewer adverse effects (Abstract). They teach administration of R-MDMA significantly increased murine social interaction and facilitated extinction of conditioned freezing, yet unlike racemic MDMA, it did not increase locomotor activity, produce signs of neurotoxicity, or increase body temperature (Id.). They teach R-MDMA could be a more viable therapeutic option for the treatment of PTSD and other disorders for which SR-MDMA is currently being investigated (Id.). Regarding Claim 17, they teach dissolving R(-)-3,4-methylenedioxymethamphetamine (R-MDMA) in 0.9% sterile saline and administering via intraperitoneal injection at a volume of 10 ml/kg to male C57BL/6 mice aged 10-16 weeks in the fear conditioning experiments and to C57BL/6 mice aged 7-10 weeks in all other experiments (p.197, right column, “Methods”). They teach administering R-MDMA (50 mg/kg) given twice at a two-hour interval (p.198, left column, “Body temperature monitoring”).
PITTS ET AL. teach the use of (±)-3,4-methylenedioxymethamphetamine ((±)-MDMA) as an adjunct to psychotherapy in the treatment of psychiatric and behavioral disorders dates back over 50 years. They teach the clinical utility of (±)-MDMA is potentially mitigated by a range of demonstrated adverse effects and that one potential solution could lie in the individual S(+) and R(−) enantiomers that comprise (±)-MDMA. They teach the current preclinical evidence suggests that R(−)-MDMA may provide an improved therapeutic index, maintaining the therapeutic effects of (±)-MDMA with a reduced side effect profile, and that future investigations should investigate the therapeutic potential of R(−)-MDMA (Abstract). They teach (±)-MDMA was said to facilitate the therapeutic alliance between patient and therapist, i.e., patients were more at ease, willing to engage in therapy, and to talk honestly about themselves and their problems when (±)-MDMA was administered as an adjunct during therapy (paragraph bridging p.377-378). They teach (±)-MDMA demonstrates enantiospecific effects on multiple receptors, including dopamine, serotonin, and norepinephrine (p.379-380). With regard to reducing neurotoxicity of MDMA and MDA as recited in Claim 20, they teach that while few studies have assessed the toxicity of the individual enantiomers, there is some compelling evidence from rodent studies that the neurotoxicity of (±)-MDMA is driven by the S(+) enantiomer, and that R(−)-MDMA has substantially lower or potentially no neurotoxicity (p.381-382, “Neurotoxicity”). With regard to reducing physical dependence or abuse liability of MDMA and MDA as recited in Claim 30, they teach the one human study of the behavioral effects of the enantiomers of (±)-MDMA concluded that S(+)-MDMA was the active enantiomer because no dose of R(−)-MDMA produced even “nominal” intoxication, pupil dilation, or jaw clenching and that this lack of intoxication following R(−)-MDMA could indicate lower abuse liability. They also teach a study in nonhuman primates suggests that R(−)-MDMA may have lower abuse liability than (±)-MDMA or S(+)-MDMA (p.384, “Abuse-related behavioral effects”). They suggest that, based on the literature reviewed therein, which currently indicates that R(−)-MDMA has reduced DA release and neurotoxic and abuse liability while maintaining equal efficacy in increasing social behavior and enhancing fear conditioning extinction, R(−)-MDMA may permit a greater breadth of clinical viability (p.385, paragraph bridging left and right columns). They teach the reduced liability for toxicity, hyperthermia, and acute hypertension induced by R(−)-MDMA could further increase the clinical utility of MDMA, opening the door to a wider range of psychiatric conditions and treatment regimens. Importantly, they teach that recent preclinical studies on the therapeutic-like effects of (±)-MDMA have shown that R(−)-MDMA is equally efficacious to (±)-MDMA (p.386, left column, first full paragraph). Also see paragraph bridging p.386-387 (“R(−)-MDMA is equally effective in several preclinical studies of therapeutic-like effects, with reduced liability for toxicity, hyperthermia, hypertension, and abuse”).
It would have been obvious to a person of ordinary skill in the art to orally administer a composition comprising R(−)-MDMA in an oral dosage form to an autistic individual because the prior art teaches MDMA-assisted therapy for social anxiety in autistic adults and teaches that R(−)-MDMA is equally effective in several preclinical studies of therapeutic-like effects, with reduced liability for toxicity, hyperthermia, hypertension, and abuse. A person of ordinary skill in the art would have a reasonable expectation of success in formulating R(−)-MDMA into an oral dosage form, e.g., a solution or capsule, and orally administering the composition to an individual because such compositions were already known in the art and expressly taught to be equally effective in several preclinical studies of therapeutic-like effects, with reduced liability for toxicity, hyperthermia, hypertension, and abuse, compared to racemic MDMA.
Regarding the newly added limitation “wherein the method is not an adjunct to psychotherapy”, a person of ordinary skill in the art would have been well aware of the beneficial therapeutic effects of MDMA outside of its use as an adjunct to psychotherapy. Indeed, psychotherapy is completely unrelated to the biological effects of MDMA administration. For example, HYSEK ET AL. teach that administration of MDMA enhances emotional empathy and prosocial behavior (Abstract). A person of ordinary skill in the art would reasonably expect that such beneficial therapeutic to also occur in autistic individuals outside of an adjunct psychotherapy session. BOUSO teaches that MDMA “is both a facilitator of psychotherapy and a type of therapy in and of itself (p.253, 1st full paragraph) (Emphasis Added). GREER ET AL. teach that they “rarely initiated psychotherapeutic interaction with people during their sessions [sessions of MDMA ingestion]”. They teach their role was to be available for physical needs, to comfort, and to help give perspective when requested (p.375, right column, 2nd full paragraph). Thus, even when characterized by the authors as “therapeutic sessions with MDMA”, it was the MDMA itself that was the therapy, not psychotherapy, i.e., MDMA was not an “adjunct to psychotherapy”, it was the therapy.
One exemplary rationale for the Examiner’s determination of obvious is the combination of prior elements according to known methods to yield predictable results. Here, the Examiner finds that the prior art teaches each element claimed, i.e., a teaching of oral compositions comprising MDMA and oral administration of such compositions in MDMA-assisted therapy for social anxiety in autistic adults (Danforth 2016 and Danforth 2018) and a teaching that R(−)-MDMA is equally effective as racemic MDMA in several preclinical studies of therapeutic-like effects, with reduced liability for toxicity, hyperthermia, hypertension, and abuse (Curry et al. and Pitts et al.). The Examiner finds that one of ordinary skill in the art could have combined these elements by known methods, i.e., formulating R(−)-MDMA in known oral dosage forms such as solutions or capsules and orally administering these compositions to an individual. A person of ordinary skill in the art would have recognized that administering a composition comprising R(−)-MDMA would reasonably have similar therapeutic efficacy as racemic MDMA with reduced liability for toxicity, hyperthermia, hypertension, and abuse as expressly suggested in the cited prior art.
Another exemplary rationale supporting the Examiner’s determination of obviousness is the substitution of R(−)-MDMA for racemic MDMA to obtain predictable results. Here, the Examiner finds that the prior art taught a method of orally administering racemic MDMA to autistic individuals to enhance the effectiveness of psychotherapy (Danforth 2016 and Danforth 2018), which differs from the claimed methods by the substitution of R(−)-MDMA with racemic MDMA. It should be noted, however, that racemic MDMA comprises about 50% S(+)-MDMA and 50% R(-)-MDMA. The prior art teaches R(−)-MDMA is equally effective as racemic MDMA in several preclinical studies of therapeutic-like effects, with reduced liability for toxicity, hyperthermia, hypertension, and abuse (Curry et al. and Pitts et al.). The prior art teaches that MDMA has beneficial therapeutic effects outside of as an adjunct to psychotherapy. As such, a person of ordinary skill in the art could have readily and predictably substituted racemic MDMA with R(−)-MDMA and the results of such substitution, e.g., similar therapeutic efficacy as racemic MDMA with reduced liability for toxicity, hyperthermia, hypertension, and abuse, would have been predictable because they are expressly suggested by the cited prior art.
Claim 10 requires the R(-)-enantiomer of MDMA is administered in a dose of 10-1000 mg R(−)-MDMA and administering 10-1000 mg R(−)-MDMA. Danforth 2018 teach autistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) and that the MDMA was compounded with lactose and placed into gelatin capsules by a research pharmacist. As racemic MDMA comprises about 50% of S(+)-MDMA and 50% R(-)-MDMA, Danforth 2018 teaches administering the R(-)-enantiomer of MDMA at a dose of 37.5 mg to 62.5 mg, thus meeting the limitation of claim 10. Furthermore, Pitts et al. teach that maximal effects of R(−)-MDMA were achieved with slightly higher doses of R(−)-MDMA compared to (±)-MDMA. In squirrel monkeys, they teach MDMA dose dependently increased huddling among socially housed conspecifics and increased the number of affiliative vocalizations, with both effects being maximally increased following 1 mg/kg (±)-MDMA. They teach R(−)-MDMA had equivalent efficacy for increasing both behaviors with peak effects at doses of 3.0 and 1.7 mg/kg, respectively (p.383, right column, last paragraph). Curry et al. expressly suggest that “an effective dose of R-MDMA in humans may be around 267 mg” (p.204, left column, last paragraph). Accordingly, formulating R(−)-MDMA in the same or higher dose than the 75-125 mg used for administering (±)-MDMA would have been prima facie obvious and expected to have similar effects to (±)-MDMA while limiting toxicity, hyperthermia, hypertension, and abuse. Furthermore, "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, the generally conditions for orally administering R(−)-MDMA to an autistic individual undergoing psychotherapy are taught in the cited prior art. It is therefore not inventive to discover the optimal oral dose of R(−)-MDMA for treating a human subject, e.g., the 267 mg dose as expressly suggested by Curry et al.
Claim 11 requires administering the R(−)-MDMA “daily”. Danforth 2018 teach that the MDMA is administered on the day of psychotherapy. It would be obvious, therefore, to administer R(−)-MDMA on each day an autistic individual undergoes psychotherapy.
Accordingly, claims 9-11, 17-18, 20, 25, 30, and 36-37 are properly rejected as being prima facie obvious over the combined teachings of the cited prior art.
Response to Arguments
Applicant’s arguments are moot in view of the modified ground of rejection set forth supra, which was necessitated by the addition of the limitation “wherein the method is not an adjunct to psychotherapy” to the claims. Applicants argue that the Office characterizes both Danforth 2016 and Danforth 2018 as relating to MDMA-assisted therapy and that the Office has not identified any teaching in the references of using MDMA to treat ASD, much less in a method that is not an adjunct to psychotherapy.
In response, the Examiner has additionally cited HYSEK ET AL., BOOSO, and GREER ET AL. to address the newly added limitation and to provide the requisite motivation to administer MDMA as a therapeutic agent in the absence of psychotherapy.
Claim(s) 13-15
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over DANFORTH ET AL. (Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2016, vol. 64, p.237-249) (hereinafter “Danforth 2016”), DANFORTH ET AL. (Psychopharmacology, 2018, vol. 235, p.3137-3148) (hereinafter “Danforth 2018”), CURRY ET AL. (Neuropharmacology, 2018, vol. 128, p.196-206) and PITTS ET AL. (Psychopharmacology, 2018, vol. 235, p.377-392) in view of HYSEK ET AL. (Journal of Clinical Psychopharmacology, 2013, 33(5), p.658-666), BOUSO ("Using MDMA in the treatment of post-traumatic stress disorder" in Julie Holland (Ed.), Ecstasy: The Complete Guide: A Comprehensive Look at the Risks and Benefits of MDMA. 2001:248-260), and GREER ET AL. (Journal of Psychoactive Drugs, 1998, 30(4), p.371-379) as applied to claims 9-11, 17-18, 20, 25, 30, and 36-37 above, and further in view of ELLIOTT ET AL. (J. Forensic Sci., 2020, vol. 65, no. 3, p.913-920).
Claims 13-15 require the R-MDMA is chemically modified to include a prodrug bound to an amine group, wherein the prodrug in an amino acid selected from, inter alia, lysine.
The teachings of Danforth 2016, Danforth 2018, Curry et al., and Pitts et al. are as applied to claims 9-11, 17-18, 20, 25, 30, and 36-37 supra, which teachings are herein incorporated by reference in their entirely and applied equally to claims 13-15.
ELLIOTT ET AL. teach prodrugs of psychoactive substances (Abstract). They teach lisdexamfetamine consists of dextroamphetamine (d-amphetamine) derivatized with the amino acid L-lysine chemically modified with the L-lysine bound to an amine group.
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(p.914, left column, “Amphetamines”; Fig. 1A). They teach that while lisdexamfetamine is itself pharmacologically inactive, in vivo peptidase enzymes associated with red blood cells hydrolyze the amide bond, thereby allowing pharmacological effects being exerted through d-amphetamine. They teach this delayed absorption and metabolic profile for formation of the active drug reduces lisdexamfetamine’s abuse liability and increases its safety profile (Id.). They teach lysine-MDMA has been mentioned in some Internet user forums (p.914, paragraph bridging left and right columns).
It would have been obvious to a person of ordinary skill in the art to chemically modify R(−)-MDMA by attaching an amino acid such as lysine to the free amine group to form a prodrug. The use of known technique to improve a similar product in the same way is prima facie obvious. Here, the prior art teaches racemic MDMA and R(−)-MDMA and teaches R(−)-MDMA would be expected to have similar therapeutic efficacy as racemic MDMA with reduced liability for toxicity, hyperthermia, hypertension, and abuse. The prior art teaches chemical modification of amphetamines into prodrugs via attachment of an amino acid such as lysine to an amine group, which has been applied to d-amphetamine, whereas lysine-MDMA has been mentioned in some Internet user forms (Elliott et al.). Given their close structural similarity, a person of ordinary skill in the art would have recognized that R(−)-MDMA could have predictably been modified in the same way to afford an R(−)-MDMA prodrug.
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A person of ordinary skill in the art would have had a reasonable expectation that the so formed Lysine-R(-)-MDMA prodrug would be physiologically inactive until cleaved by in vivo peptidase enzymes to hydrolyze the amide bond, thereby allowing pharmacological effects being exerted through R(-)-MDMA.
Regarding Claim 15, which requires the composition is in a “continual slow-release formulation”, because a lysine prodrug of R(-)-MDMA would need to be cleaved in vivo by peptidase enzymes to hydrolyze the amide bond thereby releasing the pharmaceutically active R(-)-MDMA, a composition comprising Lysine-R(-)-MDMA prodrug would also be reasonably construed to be a “continual slow-release formulation”, i.e., it would continually release R(-)-MDMA as the Lysine-R(-)-MDMA prodrug is metabolized in vivo.
Accordingly, claims 13-15 are properly rejected as being prima facie obvious over the combined teachings of the cited prior art.
Response to Arguments
The Examiner’s response to Applicant’s traversal of the rejection of claims 9-11, 17-18, 20, 25, 30, and 36-37 is herein incorporated by reference in its entirety and applied equally to claims 13-15.
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.
Copending Application No. 18/186,494
Claims 9-11, 13-15, 17-18, 20, 25, 30, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 18/186,494 (reference application) in view of DANFORTH ET AL. (Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2016, vol. 64, p.237-249) (hereinafter “Danforth 2016”) and DANFORTH ET AL. (Psychopharmacology, 2018, vol. 235, p.3137-3148) (hereinafter “Danforth 2018”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application claims are generic to the claimed methods, encompassing the treatment of any medical condition comprising administering an effective amount of a composition of an R(-)-enantiomer of MDMA. The present amendments do not patentably distinguish the claims from those of the ‘682 application because the oral administration of a composition comprising an R(-)-enantiomer of MDMA to an individual having autism would be prima facie in view of Danforth 2016 and Danforth 2018.
DANFORTH 2016 teach MDMA-assisted therapy as a new treatment model for social anxiety in autistic adults (Title; Abstract). They teach ample anecdotal data regarding the MDMA/Ecstasy experiences of autistic individuals available through spontaneous, first-person accounts posted in online discussion forums provided foundational support for clinical research on MDMA-assisted therapy for social anxiety with autistic adults (p.243, right column, first full paragraph). They teach for the present FDA-compliant, IRB-approved pilot investigation of the effects of MDMA-assisted therapy on social anxiety in autistic adults, a placebo-controlled, double-blind methodology is being employed, utilizing an MDMA dosage in the range of 75 mg–125 mg (p.244, left column, second full paragraph).
DANFORTH 2018 report on the findings of the MDMA-assisted therapy for social anxiety in autistic adults study first taught in Danforth 2016. They teach autistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) or inactive placebo (0 mg, n = 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting (Abstract). Improvement in Leibowitz Social Anxiety Scale (LSAS) scores from baseline to the primary endpoint was significantly greater for MDMA group
compared to the placebo group (P = 0.037) (Id.). Regarding administering an “oral dosage form of a composition comprising the R(-)-enantiomer of MDMA”, they teach MDMA
was synthesized by David Nichols at Purdue University, compounded with lactose, and placed into gelatin capsules by a research pharmacist (p.3138, left column, first full paragraph).
Accordingly, it would have been prima facie obvious to treat autism spectrum disorder, e.g., autism, in an individual comprising administering an oral dosage form of an effective amount of a composition of an R(-)-enantiomer of MDMA.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 18/186,764
Claims 9-11, 13-15, 17-18, 20, 25, 30, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 18/186,764 (reference application) in view of DANFORTH ET AL. (Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2016, vol. 64, p.237-249) (hereinafter “Danforth 2016”) and DANFORTH ET AL. (Psychopharmacology, 2018, vol. 235, p.3137-3148) (hereinafter “Danforth 2018”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application claims are generic to the claimed methods, encompassing the treatment of any medical condition comprising administering an effective amount of a composition of an R(-)-enantiomer of MDMA. The present amendments do not patentably distinguish the claims from those of the ‘682 application because the oral administration of a composition comprising an R(-)-enantiomer of MDMA to an individual having autism would be prima facie in view of Danforth 2016 and Danforth 2018.
DANFORTH 2016 teach MDMA-assisted therapy as a new treatment model for social anxiety in autistic adults (Title; Abstract). They teach ample anecdotal data regarding the MDMA/Ecstasy experiences of autistic individuals available through spontaneous, first-person accounts posted in online discussion forums provided foundational support for clinical research on MDMA-assisted therapy for social anxiety with autistic adults (p.243, right column, first full paragraph). They teach for the present FDA-compliant, IRB-approved pilot investigation of the effects of MDMA-assisted therapy on social anxiety in autistic adults, a placebo-controlled, double-blind methodology is being employed, utilizing an MDMA dosage in the range of 75 mg–125 mg (p.244, left column, second full paragraph).
DANFORTH 2018 report on the findings of the MDMA-assisted therapy for social anxiety in autistic adults study first taught in Danforth 2016. They teach autistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) or inactive placebo (0 mg, n = 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting (Abstract). Improvement in Leibowitz Social Anxiety Scale (LSAS) scores from baseline to the primary endpoint was significantly greater for MDMA group
compared to the placebo group (P = 0.037) (Id.). Regarding administering an “oral dosage form of a composition comprising the R(-)-enantiomer of MDMA”, they teach MDMA
was synthesized by David Nichols at Purdue University, compounded with lactose, and placed into gelatin capsules by a research pharmacist (p.3138, left column, first full paragraph).
Accordingly, it would have been prima facie obvious to treat autism spectrum disorder, e.g., autism, in an individual comprising administering an oral dosage form of an effective amount of a composition of an R(-)-enantiomer of MDMA.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending Application No. 18/331,682
Claims 9-11, 13-15, 17-18, 20, 25, 30, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of copending Application No. 18/331,682 (reference application) in view of DANFORTH ET AL. (Progress in Neuro-Psychopharmacology & Biological Psychiatry, 2016, vol. 64, p.237-249) (hereinafter “Danforth 2016”) and DANFORTH ET AL. (Psychopharmacology, 2018, vol. 235, p.3137-3148) (hereinafter “Danforth 2018”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application claims are generic to the claimed methods, encompassing the treatment of any medical condition comprising administering an effective amount of a composition of an R(-)-enantiomer of MDMA. The present amendments do not patentably distinguish the claims from those of the ‘682 application because the oral administration of a composition comprising an R(-)-enantiomer of MDMA to an individual having autism would be prima facie in view of Danforth 2016 and Danforth 2018.
DANFORTH 2016 teach MDMA-assisted therapy as a new treatment model for social anxiety in autistic adults (Title; Abstract). They teach ample anecdotal data regarding the MDMA/Ecstasy experiences of autistic individuals available through spontaneous, first-person accounts posted in online discussion forums provided foundational support for clinical research on MDMA-assisted therapy for social anxiety with autistic adults (p.243, right column, first full paragraph). They teach for the present FDA-compliant, IRB-approved pilot investigation of the effects of MDMA-assisted therapy on social anxiety in autistic adults, a placebo-controlled, double-blind methodology is being employed, utilizing an MDMA dosage in the range of 75 mg–125 mg (p.244, left column, second full paragraph).
DANFORTH 2018 report on the findings of the MDMA-assisted therapy for social anxiety in autistic adults study first taught in Danforth 2016. They teach autistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) or inactive placebo (0 mg, n = 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting (Abstract). Improvement in Leibowitz Social Anxiety Scale (LSAS) scores from baseline to the primary endpoint was significantly greater for MDMA group
compared to the placebo group (P = 0.037) (Id.). Regarding administering an “oral dosage form of a composition comprising the R(-)-enantiomer of MDMA”, they teach MDMA
was synthesized by David Nichols at Purdue University, compounded with lactose, and placed into gelatin capsules by a research pharmacist (p.3138, left column, first full paragraph).
Accordingly, it would have been prima facie obvious to treat autism spectrum disorder, e.g., autism, in an individual comprising administering an oral dosage form of an effective amount of a composition of an R(-)-enantiomer of MDMA.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue they will consider filing a terminal disclaimer over these co-pending applications after receiving an indication that each of the currently rejected claims is allowable.
As no such terminal disclaimers have been filed and no claims are in condition for allowance, the rejections are maintained.
Conclusion
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
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/James D. Anderson/Primary Examiner, Art Unit 1629
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