DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
2. Applicant's amendment and response, filed March 4, 2025, has been reviewed by the examiner and entered of record in the file.
3. Claims 1 and 2 are amended, and claims 4-9 are cancelled.
4. Claims 1, 2 and 10 are under examination and are the subject of this office action.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on December 15, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Previous Claim Rejections - 35 USC § 112(a)
6. Claims 1, 2, 4, 5 and 10 were previously rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement regarding the scope of a composition comprising a combination of any empathogen/ entactogen with any psychedelic, as previously claimed.
7. In view of Applicant’s amendatory changes, canceling claims 4-9 and limiting the scope of claims 1, 2 and 10 to a composition comprising MDMA and LSD, the previous rejection under 35 USC § 112(a) for lack of written description is overcome and is withdrawn.
Previous Claim Rejections - 35 USC § 103
8. Claims 1, 2, 4-6, 8 and 10 were previously rejected under 35 U.S.C. 103 as being unpatentable over M. D. Schechter, (European Journal of Pharmacology, 1998).
9. In view of Applicant’s amendments to incorporate the limitations of claims 7 and 9 into claim 1, the previous obviousness rejection is withdrawn. However, please refer to the newly applied obviousness rejection, below.
10. Claims 1, 2 and 10 are newly rejected under 35 U.S.C. 103 as being unpatentable over M. D. Schechter, European Journal of Pharmacology (1998), further in view of Sessa and Fischer, Drug Science 2015 (cited on Applicant’s IDS of March 4, 2025).
This rejection is newly applied as necessitated by Applicant’s amendments to the claims.
Claim 1, as amended, is drawn to a dosage form comprising:
(a) 3,4-methylenedioxymethamphetamine (MDMA); and
(b) lysergic acid diethylamide (LSD),
wherein MDMA is present in a dose of 20-200 mg and LSD is present in a dose of 0.05 mg-0.3 mg.
11. Schechter teaches the combined administration of MDMA and LSD in fawn-hooded rats wherein MDMA and LSD potentiate each other, i.e., “a sub-threshold discriminative dose of MDMA combined with a sub-threshold dose of LSD produce a large and significant increase in MDMA stimulus discrimination,” (see page 133, right column, last paragraph). Schechter teaches the co-administration of MDMA and LSD, wherein each drug is administered in the form of a saline solution, via intraperitoneal injection, at the same time (see page 132, left column).
12. Schecter additionally teaches that MDMA is administered at a dose of from 0.0315 — 2.0 mg/kg, which is equivalent to a total dose of 2.0 mg – 130 mg (assuming an average 65 kg human) and overlaps the instantly recited dosage range of from 20 mg -200 mg, (see page 132, left column, last paragraph -right column, first paragraph). Though Schecter does not disclose the exact claimed weight values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness, In re Peterson. 65 USPQ2d 1379,1382 (Fed. Cir. 2003). And, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Thus, one of skill in the art would be motivated to optimize the dose amount of MDMA in a composition comprising MDMA and the psychedelic LSD, with a reasonable expectation of success.
18. Schecter does not teach a composition comprising both MDMA and LSD in the same dosage form.
19. Yet, Schecter provides evidence that humans take the combination of LSD and MDMA, i.e., “the co-administration of LSD and MDMA has reached a prevalence that has allowed for the street terminology ‘candyflipping’ to describe the combination” (see abstract). As such, Schecter teaches the administration of both drugs at the same time, with the same excipients (i.e., saline solution); therefor it would be obvious for one of skill in the art before the effective filing date of the claimed invention to combine said drugs in the same dosage form for ease of administration. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law, please see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings). Furthermore, MPEP 2144 teaches that the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
20. In the instant case, two known compounds administered together as taught by Schecter could be combined in a composition in order to achieve an additive antidepressive effect, with the expected result of a composition suitable for the treatment of depression.
Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Thus, one skilled in the art before the effective filing date of the claimed invention would have been motivated to combine MDMA and LSD in composition, in the same unit dosage form, with a reasonable expectation of success.
21. Schecter does not teach the dosage of LSD.
22. Yet, Sessa and Fischer teach that LSD is commonly employed at a dosage of 50-200 g (i.e., equivalent to 0.05-0.200 mg), (page 3, left column, under “The choice of and dosages of substances used for the sessions”).
23. Thus, the range of 0.05-0.3 mg of LSD is reasonably suggested by 0.05-0.200 mg taught by Sessa and Fischer. The prior art does not disclose the exact claimed weight values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See In re Peterson. 65 USPQ2d 1379,1382 (Fed. Cir. 2003). And, the optimization of result effective parameters (e.g., dosage range) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that "[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 optimization with a reasonable expectation of success.
24. Thus, in view of Sessa and Fischer, one of skill in the art before the effective filing date of the claimed invention would have been motivated to optimize the dose amount of LSD to arrive at a dose of between 0.05-0.3 mg.
As such, claim 1 is prima facie obvious.
Claim 2 is drawn to claim 1, and limits wherein the MDMA and LSD have different release profiles.
25. Schechter teaches the additive effects of the combined administration of MDMA and LSD in the same form of administration at the same time (i.e., saline solution for intraperitoneal injection), but is silent to the limitation of the MDMA and LSD having different release profiles.
26. Yet, claim 2 is drafted in terms of the intended outcome of the administration of MDMA and a psychedelic, i.e., “...wherein MDMA and said psychedelic have different release profiles.” A claimed composition maybe obvious because it was suggested by, or structurally similar to, a prior art composition even though a particular benefit of the claimed composition asserted by patentee is not expressly disclosed in the prior art. It is the differences in fact in their respective properties which are determinative of nonobviousness. If the prior art composition does in fact possess a particular benefit, even though the benefit is not recognized in the prior art, Applicant's recognition of the benefit is not in itself sufficient to distinguish the claimed composition from the prior art, In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). In this case, the release profiles are considered latent properties of the combined administration of MDMA and LSD as previously disclosed by Schechter, and the alleged unexpected result does not confer patentability.
27. And, the limitation of different release profiles is a functional limitation that characterizes intrinsic properties of the claimed composition, which is taught by Schechter. As recognized by MPEP § 2112.01(II), "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
As such, claim 2 is prima facie obvious.
Claim 10 is drawn to claim 1, and limits wherein the dosage form is in oral dosage form.
28. Schecter suggests the combined administration of MDMA and LSD in the same dosage form, but does not teach an oral composition comprising MDMA and LSD. However, the optimization of result-effective parameters (e.g., route of administration) is obvious as being within the skill of the artisan. In this case, combining both MDMA and LSD into a single oral composition for ease/ efficiency of administration to a patient in need thereof is recognized as within the ordinary capabilities of one skill in the art. Thus, it would be obvious for one of skill in the art to optimize the route/form of administration of the composition taught by Schecter.
As such, claim 10 is prima facie obvious.
29. Claims 7 and 9 were previously rejected under 35 U.S.C. 103 as being unpatentable over M. D. Schechter, European Journal of Pharmacology 1998, as applied to claims 1, 2, 4-6, 8 and 10, further in view of Sessa and Fischer, Drug Science 2015.
30. In view of Applicant’s cancellation of claims 7 and 9, the previous obviousness rejection is withdrawn.
Response to Arguments
31. Applicant traverses the previous obviousness rejection over Schecter, further in view of Sessa and Fischer, and argues the following points:
(i) Applicant argues that that Claim 1, as amended recites the following features:
a) A composition comprising 3,4-methylenedioxymethamphetamine (MDMA),
b) and a psychedelic lysergic acid diethylamide (LSD)
c) in the same dosage form,
d) wherein MDMA is present in a dose of 20-200 mg and
e) LSD is present in a dose of 0.05-0.3 mg.
Applicant alleges that, “the Office appears to be impermissibly determining whether the differences themselves would have been obvious, rather than whether the claimed invention as a whole would have been obvious.7 At least because the Office has failed to identify why a composition comprising all of features a), b), c), d), and e) together, a prima facie case of obviousness has not been established.
(ii) Applicant disagrees that the overlapping ranges asserted by the Office for features d) and e) are sufficient to establish a prima facie case of obviousness. Applicant contends that, "invocation of the presumption is not independent of different inventive contexts."8 Applicant alleges that “[t]he number of differences between the prior art and the claims, and the relationship of those differences, is relevant to the question of whether the presumption of obviousness, truncating usual full case- specific obviousness inquiry, is appropriate.9 As the Office has failed to identify why a skilled artisan would find the claimed invention obvious, based solely on the overlapping ranges identified in the office action, a prima facie of obviousness has not been established.”
32. Applicant's arguments have been fully considered but they are not persuasive. The combined art of record suggests the administration of MDMA and LSD in the same dosage form, in the dosage ranges recited, at least for the following reasons:
Schechter teaches the co-administration of MDMA and LSD, wherein each drug is administered in the form of a saline solution, at the same time (see page 132, left column), thus the administration of both drugs at the same time, with the same excipients (i.e., saline solution) would have been obvious to combine in the same dosage form for ease of administration. Please refer to MPEP 2144.06 “I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE” wherein Kerkhoven is specifically referenced:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As Schecter teaches both the of the components (a) MDMA and (b) LSD, as well as the suggestion of concurrent administration, the limitations of a), b), and c) are satisfied by Schecter.
Schecter additionally teaches that MDMA is administered at a dose of from 0.0315 — 2.0 mg/kg, which is equivalent to a total dose of 2.0 mg – 130 mg (assuming an average 65 kg human), and within the range of 20-200 mg required by d) above.
Sessa and Fischer, which is directed to dosage and administration of psychedelics, specifically teach that LSD is commonly employed at a dosage of 50-200 g (i.e., equivalent to 0.05-0.200 mg), (page 3, left column), which is within the scope of 0.05-0.3 mg required by e) above. And, it is not inventive to discover the optimum or workable ranges by routine optimization with a reasonable expectation of success.
Moreover, the determination of known effective amounts of known active agents is considered well in the competence level of one of ordinary skill in the art, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As each of Schecter, and Sessa and Fischer, teaches a dosage range that either completely embraces or overlaps the recited range, it would have been obvious to have chosen a dose from among those known in order to achieve a beneficial effect upon administering the composition in a single dosage form.
As such, the combined prior art of record teaches every one of a)-e) above, such that it would have been obvious for one of skill in the art to follow the teachings of the prior art to arrive at the claimed invention, with a reasonable expectation of success.
Previous Double Patenting Rejections
33. 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).
34. 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).
35. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
36. Claims 1, 2 and 10 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,364,221.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Applicant’s instant claims are discussed in detail, above.
37. CLAIM 1 of U.S. Pat. No. 11,364,221 recites a method of enhancing positive therapeutic effects of a psychedelic, including the steps of: administering an empathogen/ entactogen and a psychedelic in a same single oral dosage form to an individual, wherein the empathogen/entactogen induces a positive psychological state in the individual and is administered in a dose of 20-200 mg; and enhancing a positive response to the psychedelic [emphasis added]. CLAIM 2 recites the method of claim 1, wherein the empathogen/entactogen and psychedelic have different release profiles. CLAIM 3 recites the method of claim 1, wherein the psychedelic is chosen from the group consisting of psilocybin, psilocin, lysergic acid diethylamide (LSD), mescaline, dimethyltryptamine (DMT), 2,5-dimethoxy-4-iodoamphetamine (DOI), 2,5-dimethoxy-4-bromo-amphetamine (DOB), phenethylamine or tryptamine psychedelics, salts thereof, analogs thereof, prodrugs thereof, and homologues thereof. CLAIM 4 recites the method of claim 1, wherein the psychedelic is LSD and is administered in a dose of 0.05-0.3 mg. CLAIM 5 recites the method of claim 1, wherein the empathogen/ entactogen is chosen from the group consisting of 3,4-methylenedioxymeth-amphetamine (MDMA), 3,4-methylen-dioxyamphetamine (MDA), 3,4,-methylene-dioxyethylamphetamine (MDEA), 5,6-methylenedioxy-2-aminoindane (MDAI), mephedrone, methylone, 3-methylmeth-cathinone (3-MMC), homologues thereof, analogues thereof, and prodrugs thereof. CLAIM 6 recites the method of claim 1, wherein the psychedelic is a short-acting psychedelic.
38. Thus, the subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
39. The claims of the ‘221 patent and the instant claims recite an empathogen/ entactogen and a psychedelic in a same single oral dosage form wherein the empathogen/ entactogen is MDMA and is administered at a dose of 20-200 mg, and wherein the psychedelic is LSD and is administered in a dose of 0.05-0.3 mg.
38. Thus, nothing unobvious is seen in one skilled in the art picking and choosing from the limited genus of empathogens/ entactogens recited in claim 5 of the ‘221 patent and selecting MDMA, together with LSD as recited in claim 4, in composition, in the same oral dosage form.
Response to Arguments
39. Applicant asserts that they will address the nonstatutory double
patenting rejections over the reference patent, and will consider filing a terminal disclaimer, once the claims are acknowledged by the Office as otherwise allowable.
40. Accordingly, the previous obviousness-type double patenting rejection is maintained.
Conclusion
41. Claims 1, 2 and 10 are present in the application. Claims 1, 2 and 10 are currently rejected. No claim is presently allowed.
42. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
43. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-13101310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JANET L COPPINS/Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
Prosecution Insights