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 .
Status of the Application
Claims 1-17 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 12/12/2025 are acknowledged. Claims 4-9 and 13-16 remain withdrawn, as being drawn to an unelected invention or specie. Claims under consideration in the instant office action are claims 1-3, 10-12, and 17.
Applicants' arguments, filed 12/12/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1-3, 10-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Uthaug et al. (A single inhalation of vapor from dried toad secretion containing 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms, Psychopharmacology, 2019, 236, pp. 2653-2666, as disclosed in IDS) in view of Turner (US 2013/0281401, as disclosed in IDS).
Uthaug et al. teaches the effect of 5-MeO-DMT on cognition (see abstract). Uthaug et al. teaches dried toad secretion comprising 5-MeO-DMT and 5-hydroxy-dimethyltryptamine (bufotenin, 5-HO-DMT) (pg. 2656, right column, first paragraph). Uthaug et al. teaches the secretion administered in an amount of 100-120 mg, wherein 5-Meo-DMT can be present in an amount of 283.3 mg/g and 5-OH-DMT is present in an amount of 3.530 mg/g (pg. 2656, right column, first paragraph; see Table 2). Thus, 5-MeO-DMT can be administered in an amount of 34 mg (283.3 mg / 1,000 mg x 120 mg = 34 mg) and 5-OH-DMT in an amount of 0.42 mg (3.530 mg / 1,000 mg x 120 mg = 0.42 mg). The molar amount of 5-MeO-DMT would be 1.5 x 10-4 mol (34 mg / 218,300 mg/mol = 1.5 x 10-4 mol) and the molar amount of 5-OH-DMT would be (0.42 mg / 204,273 mg/mol = 2.1 x 10-6 mol), which results in a molar ratio of 71.4:1. Uthaug et al. teaches “a single administration of vapor from toad secretion containing 5-MeO-DMT produces rapid and persistent improvements in satisfaction with life, mindfulness and psychopathological symptoms, and that these changes are associated to the strength of the psychedelic experience. These results provide evidence supporting further research examining the potential therapeutic effect of 5-MeODMT.” (pp. 2664-2665, bridging paragraph).
Uthaug et al. does not teach a purified form of 5-Meo-DMT and bufotenin.
Turner is drawn towards compositions for the treatment of psychiatric disorders comprising methylsulfonylmethane, glucosamine, L-glycine, vitamin B12, and monoamine oxidase inhibitors such as 5-MeO-DMT (paragraphs 0001, 0009, 0079). Such a composition would read on the limitation “purposefully engineered” as recited in claim 1. Regarding claims 1 and 17, Turner teaches that the compounds can be prepared in purified form (paragraphs 0062, 0085). Turner teaches compositions further comprising an excipient (paragraph 0016).
It would have been obvious to one of ordinary skill in the art to formulate 5-Meo-DMT in a purified form, as suggested by Turner, and produce the claimed invention.
One of ordinary skill in the art would have been motivated to do so since Turner teaches that active compounds such as 5-MeO-DMT can be formulated in a desired degree of purity (paragraph 0085), with a reasonable expectation of success absent evidence of criticality of the particular formulation.
With regards to the limitation wherein therapeutically amount each of the purified toad secretion tryptamine and of the second active compound separately ranges from about 0.5 mg - about 200 mg, Uthaug et al. does not specifically teach the exact amounts claimed in claim 12. However, it would be within the skill of an ordinary artisan to be able to modify the concentration in order to obtain the desired psychiatric activity. It is 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant argues that “the compositions disclosed by Uthaug cannot be used to teach or suggest a composition consisting of a homogenous mixture of purified toad secretion tryptamine and a second active compound according to the claimed invention. The transitional phrase "consisting of" "excludes any element, step, or ingredient not specified in the claim." See MPEP, § 2111.03. The dried toad secretion comprising bufotenin of Uthaug would affect the novel characteristics of the claimed invention.” The Examiner respectfully disagrees since Uthaug et al. teaches “a single administration of vapor from toad secretion containing 5-MeO-DMT produces rapid and persistent improvements in satisfaction with life, mindfulness and psychopathological symptoms, and that these changes are associated to the strength of the psychedelic experience. These results provide evidence supporting further research examining the potential therapeutic effect of 5-MeODMT.” (pp. 2664-2665, bridging paragraph). Additionally, Turner teaches that the compounds can be prepared in purified form (paragraph 0062, 0085). Thus, one of ordinary skill in the art would thus be motivated to isolate and purify the recited active agents and combine them for their additive effect, which would read on the composition as recited.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that “Even if, arguendo, a person of ordinary skill the art would have been motivated to modify the composition of Uthaug by purifying 5-MeO-DMT as suggested by Turner, they still would not arrive at the claimed invention, because the only source of 5-HO-DMT/bufotenin from Uthaug is the dried toad secretions, which, as established above, comprise several other toad secretion compounds and would affect the novel characteristics of the claimed invention.” The Examiner respectfully disagrees since based on the teachings of Turner as discussed above, one of ordinary skill in the art would have been motivated to isolate and purify 5-MeO-DMT from any source, including dried toad secretions.
Conclusion
Claims 1-3, 10-12, and 17 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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691