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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed September 10th, 2025 have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 103
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.
Claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 are rejected under 35 U.S.C. 103 as being unpatentable over Curry et. al. ((2018), Separating the agony from ecstasy: R(e)-3,4-methylenedioxymethamphetamine has prosocial and therapeutic-like effects without signs of neurotoxicity in mice, Neuropharmacology, 128, 196 – 206; cited in the Office action mailed 11/19/2024), as evidence by Brooks et al. ((2011), The Significance of Chirality in Drug Design and Development, Curr Top Med Chem., 11, 760 – 770; cited in the Office action mailed 11/19/2024), in view of International Publication No. WO 2009/089494 A2 to Bosse et.al. (herein after Bosse’494; cited in the Office action mailed 11/19/2024).
Regarding claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27, Curry et. al. teach that the first of these trials found that just two SR-MDMA-paired psychotherapy sessions significantly reduced the symptoms of post-traumatic stress disorder (PTSD) (claim 13), with a sustained clinical response in 83% of SR-MDMA-treated patients compared to just 25% of those treated with placebo-paired psychotherapy (page 196 column 2 paragraph 1). Additionally, Curry et. al. teach that SR-MDMA is a racemic mixture of two enantiomers: R-MDMA and S-MDMA and that little is known about their relative contributions to the prosocial and therapeutic effects of SR-MDMA (page 197 column 1 paragraph 3). Furthermore, Curry et. al. teach that to asses therapeutic-like effects we followed up on a previous study in mice that demonstrated a single treatment of SR-MDMA can facilitate extinction learning and a long-lasting (page 197 column 1 paragraph 4).
Curry et. al. teach that the R(-)-3,4-methylenedioxymethamphetamine (R-MDMA) were supplied by the National Institute on Drug Abuse (Research Technology Branch, Research Triangle Park, NC) and was expressed as HCl salt (claims 2 and 14) (page 197 column 2 paragraph 4). While Currey et.al. is silent about the enantiomeric purity of the R-MDMA given that the study of Curry et. al. was to determine the specific enantiomeric effect of both R-MDMA and S-MDMA separately, it would have been obvious to one of ordinary skill in the art the R-MDMA sample was substantial enantiomerically pure of at least 100 % (claims 19 and 20) which would render obvious the limitation for an enantiomerically pure greater than 95 % (claim 1) and greater than 98% pure (claim 13). Additionally, as evidenced by Brooks et.al., chirality can be defined as the potential of a molecule to occur in two asymmetric forms that are non-superimposable mirror images of each other without changing the atomic composition, atom-atom connections, or bond orders (page 3 paragraph 3). Moreover, Brooks et.al. teach that proteins are often enantioselective towards their binding partners (page 1 paragraph 1 abstract).
Additionally, Curry et. al. teach that the R(-)-3,4-methylenedioxymethamphetamine (R-MDMA) were dissolved in 0.9 % sterile saline which is a pharmaceutically acceptable carrier (claim 1) and administered via intraperitoneal injection at a volume of 10 ml/kg (page 197 column 2 paragraph 4). Furthermore, Curry et. al. teach that by using the interspecies scaling equation Dose1 ¼ Dose2(Weight1/Weight2), approximate human doses can be calculated from the doses used in mice (page 204 column 1 paragraph 2). Moreover, Curry et. al. teach that assuming a 30 g mouse, 75 kg human, and an exponent of 0.8, the peak effective dose of SR-MDMA in this study is estimated to be 122 mg in a human, approximately the same dose used in recent clinical trials of SR-MDMA (125 mg) (page 204 column 1 paragraph 2). Additionally, Curry et.al. teach that based on the above equation an effective dose of R-MDMA in humans may be around 267 mg or 3.55 mg/kg (page 204 column 1 paragraph 2).
As suggested by Curry et.al. the value of 125 mg and 267 mg or 3.55 mg/kg are estimations and thus depending on the subject it would have been obvious to one of ordinary skill in the art increase or decrease the dosage for the individualized treatment outcome. Given that the prior art of Curry et. al. teach an estimated starting point of 267 mg or 3.55 mg/kg in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05). Thus the value of 125 mg and 267 mg render obvious the values of 75 mg (claims 4 and 13), 125 mg (claims 5 and 15), 175 mg (claims 6 and 16), or 225 mg of (R)-MDMA, based on (R )-MDMA free base (claims 3, 9 – 10, and 13).
However, the prior art of Curry et. al. fails to teach a solid oral dosage (claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27) wherein the solid oral dosage form is a tablet (claim 26) or a capsule (claim 27).
Nevertheless, Bosse’494 teach compositions which comprise effective amounts of analgesic to treat a subject (abstract). Additionally, Bosse’494teach one embodiment this invention provides compositions comprising (1) an effective amount of: (a) an opioid analgesic; (b) a stimulant; (c) an antiemetic; and (2) a pharmaceutically acceptable carrier or vehicle (substitute sheet Rule 26 paragraph 0008). Moreover, Bosse’494 teach compositions wherein the stimulant agent includes MDMA (3,4-methylenedioxy-N-methylamphetamine ) (page 24 paragraph 00174). Furthermore, Bosse’494 teach that the compositions can be formulated in a solid (claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27) or liquid form for oral administration which includes capsules (claim 27) or tablets (claim 26), as a powder or granule, or present in a tablet conventionally formed by compression molding (page 45 paragraph 00242). Moreover, Bosse’494 teach that dosage forms of the invention can comprise acceptable carriers or salts known in the art, such as those described in the Handbook of Pharmaceutical Excipients, American Pharmaceutical Association (1986), incorporated by reference herein in its entirety (page 45 paragraph 00242).
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition and method taught by Curry et. al. in view of Bosse’494 for a solid dosage form. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success because pharmaceutical formulations is well established in the art and within the purview of one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed September 10th, 2025, see applicant’s remarks pages 2 – 4, regarding the prior art rejection of claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 have been fully considered but they are not persuasive.
Applicant argues that a prima facie case hasn’t been meet because of the prior rejection has not shown how the cited references teach all of the claim elements (page 2 paragraph 4) which include the recitation for 75 to 225 mg R-MDMA with a purity greater than 95 % (page 2 paragraphs 1 – 2 and page 3 paragraph 2). Additionally, applicant argues that Curry et. al. teaches aways from the use of R-MDMA at the recited dosage between 75 mg and 225 mg for the treatment of PTSD (page 3 paragraph 3).
However, as stated above, Curry et.al. suggest the value of 125 mg and 267 mg or 3.55 mg/kg are estimations and thus depending on the subject it would have been obvious to one of ordinary skill in the art increase or decrease the dosage for the individualized treatment outcome. Additionally, a prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984). Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Moreover, as evidenced by the Multidisciplinary Association for Psychedelic Studies (MAPS) ((August 2021), A Manual for Adherence Ratings of MDMA-Assisted Therapy for Treatment of Posttraumatic Stress Disorder, Version 6), and NCT03537014 ((08-18-2021) Study Record Version 46) MDMA was already associated with the treatment of Post traumatic disorders with the 80 or 120 mg MDMA being useful in the study.
Furthermore, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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) (MPEP 2144.05). Therefore, the provisional prior art rejection of instant claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 is deemed proper, maintained, and made final.
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 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4 – 5, 10, 17, 20, and 22 of copending Application No. 18/990840 to Rao et.al. (herein after Rao’840) in view of International Publication No. WO 2009/089494 A2 to Bosse et.al. (herein after Bosse’494; cited in the Office action mailed 11/19/2024).
Rao’840 recite a method of treating an anxiety disorder in a subject in need thereof, comprising administering to the subject a composition comprising an enantiomerically enriched form of R(-)-3,4-methylenedioxymethamphetamine (R(-)-MDMA) (instant claim 1), or a pharmaceutically acceptable salt or prodrug thereof, wherein the administration provides a R(-)-MDMA Tmax of about 2 hours to about 10 hours and a R(-)-MDMA Cmax of about 150 ng/mL to about 3000 ng/mL following administration (reference claim 1); wherein the anxiety disorder is social anxiety disorder, or generalized anxiety disorder (reference claim 2); wherein the subject has one or more conditions comorbid with the anxiety disorder (reference claim 4) more specifically post-traumatic stress disorder (PTSD) (reference claim 5; instant claim 13).
Additionally, Rao’840 recite a method wherein about 75 mg to about 350 mg, about 75 mg to about 225 mg (instant claim 9), about 75 mg (instant claims 4 and 15), about 125 mg, about 175 mg, or about 225 mg (instant claim 6) R(-)-MDMA free base (instant claim 3, 10, 13, and 16) or an equivalent dose of the pharmaceutically acceptable salt or prodrug thereof is administered to the subject (reference claim 10); wherein administering the composition comprises injection, oral delivery (instant claim 1 and 13), transdermal delivery, or transmucosal delivery (reference claim 17); wherein the composition comprises a weight ratio of R(-)-MDMA to S(+)-MDMA ranging from about 50.1:49.9 to about 100:0 (reference claim 20; instant claims 1, 8, 12 – 13, and 19 – 20); wherein the composition comprises R(-)-MDMA in an enantiomerically enriched form of >90%,>95% (instant claim 1), >96%, >97% (instant claim 8), >98%(instant claim 13), >99%, >99.5%, >99.9%, or >99.99% (instant claim 19), or 100% (instant claim 20) relative to total MDMA (reference claim 22).
However, while copending application Rao’840 recite oral delivery Rao’840 fails to recite a solid oral dosage form (claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27) wherein the oral dosage form is a tablet (claim 26) or a capsule (claim 27).
Nevertheless, Nevertheless, Bosse’494 teach compositions which comprise effective amounts of analgesic to treat a subject (abstract). Additionally, Bosse’494teach one embodiment this invention provides compositions comprising (1) an effective amount of: (a) an opioid analgesic; (b) a stimulant; (c) an antiemetic; and (2) a pharmaceutically acceptable carrier or vehicle (substitute sheet Rule 26 paragraph 0008). Moreover, Bosse’494 teach compositions wherein the stimulant agent includes MDMA (3,4-methylenedioxy-N-methylamphetamine ) (page 24 paragraph 00174). Furthermore, Bosse’494 teach that the compositions can be formulated in a solid (claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27) or liquid form for oral administration which includes capsules (claim 27) or tablets (claim 26), as a powder or granule, or present in a tablet conventionally formed by compression molding (page 45 paragraph 00242). Moreover, Bosse’494 teach that dosage forms of the invention can comprise acceptable carriers or salts known in the art, such as those described in the Handbook of Pharmaceutical Excipients, American Pharmaceutical Association (1986), incorporated by reference herein in its entirety (page 45 paragraph 00242).
Therefore, it would have been obvious before the effective filing date of the instant application to modify the composition and method recited by copending Rao’840 in view of Bosse’494 for a solid dosage form. One of ordinary skill in the art would have been motivated to make this modification and have a reasonable expectation of success because pharmaceutical formulations is well established in the art and within the purview of one of ordinary skill in the art.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed September 10th, 2025, see applicant’s remarks page 4, regarding the provisional NSDP rejection of instant claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 over claims 1, 2, 4 – 5, 10, 17, 20, and 22 of copending Application No. 18/990840 to Rao et.al. (herein after Rao’840) have been fully considered but they are not persuasive.
Applicant request to address the provisional non-statutory double patenting rejection when the application is otherwise in condition for allowance (see applicant’s remarks page 4 paragraph 4).
The examiner contends that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. (MPEP 804). As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, the provisional NSDP rejection of instant claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 is deemed proper, maintained, and made final.
Conclusion
Claims 1 – 6, 8 – 10, 12 – 16, 19 – 20, and 26 – 27 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682