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 .
Priority
This application, filed 9 May, 2024, is a CIP of 18/065,665 filed 14 December, 2022, which claims benefit of the prior-filed Application N° 63/297,322 filed 1 January 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 14 March, 2025 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 9 May, 2024, in the matter of Application N° 18/659,197. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, Claims 1-19 represent all claims currently under consideration.
Specification
The disclosure is objected to because of the following informalities: inconsistent reference to the working example. Throughout the Specification, the working example is referred to as “EXAMPLE 1”, except in two instances that refer to it as only “EXAMPLE” found in Paragraph [0007], Line 5 and again in Paragraph [00050], Line 8. This discrepancy allows for the possibility that there are two working examples.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-9, 11 and 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites both “a method of treating an individual” and the separate step of “treating the individual,” without clearly setting forth whether the recited “treating” step is distinct from or merely the intended result of the administration step.
Claim 8 recites the phrase “inducing positive acute affects in the individual” which is subjective and fails to define the claimed method with reasonable clarity. The claim does not identify what constitutes a “positive acute affect,” how such an affect is measured, or what degree of effect is required.
Claim 9 recites the further step of “reducing adverse effects associated with MDMA” which is a result rather than a definite affirmative process step. The claim does not identify which adverse effects are reduced, how reduction is measured, or the degree of reduction required.
Claim 11 recites the phrase “for couples therapy”. It is unclear what additional limitation(s) is intended with the phrase “for couples therapy”. This phrase could mean: that the individual being treated with the compound should also be undergoing couple’s therapy, or that administering this composition to two individuals is considered couple’s therapy, or that a couple should simultaneously have the composition be administered then receive psychotherapy together, etc.
Claim 16 recites the phrase “determining if there are characteristics of the individual present that would not be suitable for MDMA treatment.” It is unclear what additional limitation(s) this phrase is intended to require. The Specification (Para [00058], Lines 5-7) provides two examples (cardiac issues or low mood) as criteria as not suitability for MDMA treatment. It is unclear, however, if these are the sole defining limitations or just examples and therefore indefinite.
Claim 17 recites the phrase “determining if the individual has cardiac issues”, but it is unclear if that qualifies or disqualifies the individual to be treated with R-MDMA.
Claim 18 recites the phrase “determining if the individual has previously experienced low mood after treatment with MDMA”, but it is unclear if that qualifies or disqualifies the individual to be treated with R-MDMA.
Claim 19 recites the phrase “thereby reducing abuse compared to administering MDMA” which is subjective and fails to provide objective boundaries for determining claim scope. The claim does not define what constitutes “abuse,” how abuse is measured, what degree of reduction is required, or the conditions under which the comparison to MDMA administration is made. Further, it is uncertain to which form of MDMA is referred (e.g., racemic MDMA, aka Ecstasy, etc.)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 and 16-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Pitts et al, (Psychopharmacology vol. 235,2, 2018, cited in IDS), hereinafter Pitts, as evidenced by Murnane et al (Journal of Pharmacology and Experimental Therapeutics, vol. 334, no. 2, 13 May 2010, cited in parent Application 18/065,665 IDS filed 28 February, 2023) hereinafter Murnane, Curry et al. (Neuropharmacology, vol. 128, 2018, cited in IDS) hereinafter Curry, and Schmidt et al. (Biochemical Pharmacology, vol. 36, no. 5, Mar. 1987, cited in parent Application 18/065,665 IDS filed 28 February, 2023) hereinafter Schmidt.
Regarding Claim 1, Pitts teaches that S(+) and R(-) enantiomers comprise (+)-MDMA, and that the use of (+)- MDMA as an adjunct to psychotherapy in the treatment of psychiatric and behavioral disorders dates back over 50 years (see Abstract). Furthermore, Pitts discloses a study of the effects of MDMA and its enantiomers (Pg. 1963, Col 1, Para 2) showing that the stereoisomers have different pharmacological profiles; S(+) MDMA increases dopamine and serotonin (5-HT), while R(-) MDMA less potently releases 5-HT but has little effect on dopamine release. Additionally, R(-) MDMA binds to specific receptors (Pg. 1962, Introduction.)
As Pitts expressly discloses the individual R(-)-MDMA and S(+)-MDMA enantiomers, including systemic in vivo administration and evaluation of their pharmacological effects, it therefore anticipates compositions comprising the enantiomers and methods of administering the enantiomers for treatment.
In Claims 2-6, Pitts discloses the composition which has inherent functional limitations known in the art, as further evidenced below by Murnane, Curry, and Schmidt.
Regarding Claim 2, Pitts teaches the lack of intoxication following R(−)-MDMA could indicate lower abuse liability (see § Abuse Related Behavioral Effects, Para 2).
Regarding Claim 3, Curry further teaches that R-MDMA appeared to decrease body temperature (see §3.4). To those in the art, decreased body temperature is an example of lower autonomic stimulation.
Regarding Claim 4, Curry further teaches R-MDMA would retain the prosocial and therapeutic effects but with fewer adverse effects (see Abstract).
Regarding Claim 5, Schmidt further teaches the (+)-enantiomer produced the most dramatic serotonin depletion, which is known in the art to lower mood (see Abstract).
Regarding Claim 6, Pitts teaches S(+)-MDMA released oxytocin…with twice the potency of (±)-MDMA (see Page 5, Col 1, Para 2).
Regarding Claim 7, Pitts teaches that S(+) and R(-) enantiomers comprise (+)-MDMA, and that the use of (+)- MDMA as an adjunct to psychotherapy in the treatment of psychiatric and behavioral disorders dates back over 50 years (see Abstract).
Regarding Claim 8, Pitts teaches (±)-MDMA…is considered by some researchers to be the prototypical member of a unique class of substances called entactogens [which are] characterized by their unique ability to increase feelings of love and empathy, closeness towards others, and inner peace (see Introduction).
Regarding Claim 9, Pitts discloses the composition with inherent functional limitations as further evidenced by Curry who teaches R-MDMA, would retain the prosocial and therapeutic effects but with fewer adverse effects (see Abstract).
Regarding Claim 10, Pitts teaches (±)-MDMA was useful for treating a wide range of conditions, including post-traumatic stress disorder (PTSD), phobias, psychosomatic disorders, depression, drug addiction, relationship difficulties, and end-of-life anxiety (see Intro).
Regarding Claim 16, Pitts teaches that S(+) and R(-) enantiomers comprise (+)-MDMA, and that the use of (+)- MDMA as an adjunct to psychotherapy in the treatment of psychiatric and behavioral disorders dates back over 50 years (see Abstract). The step of “evaluating an individual” is implicit in the disclosure of Pitts because it is routine and a matter of common sense that a patient is evaluated before administering therapy.
Regarding Claim 17, Pitts teaches that S(+)-MDMA has an EC50 for the dopamine transporter that is 25 times greater than R(−)-MDMA, which is known in the art to impact cardiac function.
Regarding Claim 18, Schmidt further teaches the (+)-enantiomer produced the most dramatic serotonin depletion, which is known in the art to lower mood (see Abstract).
Regarding Claim 19, Pitts teaches that 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...The lack of intoxication following R(−)-MDMA could indicate lower abuse liability (see § Abuse Related Behavioral Effects, Para 2).
Therefore, Claims 1-10 and 16-19 are anticipated by the prior art.
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.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pitts.
The teachings of Pitts are set forth in the above 35 U.S.C. 102 Rejections and
are incorporated herein. Pitts teaches that S(+) and R(-) enantiomers comprise (+)-MDMA, and that the use of (+)- MDMA as an adjunct to psychotherapy in the treatment of psychiatric and behavioral disorders dates back over 50 years (see Abstract).
Regarding Claims 12-15, Pitts discloses a study of the effects of MDMA and its enantiomers (Pg. 1963, Col 1, Para 2), and cites dosages for both in the Experimental Protocol section: racemic MDMA (0.03-1.0 mg/kg, i.m.), S(+) or R(-) MDMA (0.3-3.0 mg/kg, i.m.) (Pg. 1963, Col 2, Para 2, § Experimental Protocol.) In an average 70 kg subject, 0.3-3.0 mg/kg would be approximately 21-210 mg.
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). See MPEP § 2144.05(I)
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8, 10-11 and 21 of copending Application No. 18/065,665 and Claims 1-20 of copending Application No. 19/642,435.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed to the same or substantially the same subject matter, differing only in non-patentably distinct variations in claim scope or wording. The applications originally contained identical or substantially identical claim sets, and the presently claimed subject matter remains directed to substantially the same compositions and methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 7-8, 10 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 6, 9-10 and 20 of copending Application No. 18/191,632.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims directed to administering R-MDMA are not patentably distinct from the reference claims directed to administering a prodrug of R-MDMA that metabolizes and releases R-MDMA in the individual. The reference claims therefore define an obvious variant of the same therapeutic method, differing only in the form in which R-MDMA is administered and delivered to the individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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