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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 12, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of the following species:
Claim 3 as the elected patient species shown as follows:
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Claim 2 as the elected diagnostic criteria species shown as follows:
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Claim 13 as the elected criteria species to identify the occurrence of a peak psychedelic experience shown as follows:
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Claim 22 as the elected assessment species for a clinical response shown as follows:
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Claim 24 as the elected assessment species for a remission of depressive symptoms shown as follows:
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are maintained.
Claims 16-21, 23, and 25-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on March 12, 2026, wherein claims 1, 2-4, 6-7, 15-17, 19-23, 28-30 are amended; claims 5, 8-14, 18 and 25-27 are cancelled; and claims 24 is unchanged.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-7, 15-17, 19-24, and 28-30 are pending. Claims 16-17, 19-21, 23, and 28-30 remain withdrawn.
Claims 1-4, 6-7, 15, 22 and 24 are under examination in accordance with the elected species.
Priority
The instant application 18/675,614 filed on May 28, 2024 is a continuation of U.S. Application No. 17/431,626 filed on August 21, 2021, which is a 371 of PCT/EP2020/054803 filed on February 24, 2020, which claims priority to and the benefits of Foreign Application No. EP19158774.0 filed on February 22, 2019.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/431,626, filed on August 17, 2021.
Receipt is acknowledged of a certified copy of foreign application EP19158774.0, however the present application does not properly claim priority to the submitted foreign application. It is noted that the foreign application fails to discloses the followings:
the major depressive disorder is moderate or severe major depressive disorder as indicated by Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more or by a 17-item Hamilton Depression Rating Scale (HAM-D) score of 17 or more; the major depressive disorder is severe major depressive disorder as indicated by a MADRS score of 35 or more or by a HAM-D score of 25 or more;
the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide;
wherein a clinical response, as assessed by at least 50% improvement of a MADRS or HAM-D score, compared to a respective score prior to the administration of the 5-MeODMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof;
the patient is in remission of depressive symptoms, as assessed by a MA DRS score equal to or less than 10, or a HAM-D score equal to or less than 7, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof; and
the Peak Psychedelic Experience Questionnaire as part of the elected criteria species to identify the occurrence of a peak psychedelic experience.
Therefore, each of these findings demonstrate that claims 3-4, 7, 15, 22, 24, drawn to a method of major
depressive disorder that includes one of the limitations noted above, are not entitled to the benefit of the foreign application, and will receive an effective filing date of February 24, 2020, which is the filing date of 371 of PCT/EP2020/054803.
If this copy is being filed to obtain priority to the foreign filing date under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a), applicant must also file a claim for such priority as required by 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55. If the application was filed before September 16, 2012, the priority claim must be made in either the oath or declaration or in an application data sheet; if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet.
If the application being examined is an original application filed under 35 U.S.C. 111(a) (other than a design application), the claim for priority must be presented during the pendency of the application, and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. See 37 CFR 1.55(d)(1). If the application being examined is a national stage application under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and Regulations under the PCT. See 37 CFR 1.55(d)(2). Any claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) not presented within the time period set forth in 37 CFR 1.55 is considered to have been waived. If a claim for foreign priority is presented after the time period set forth in 37 CFR 1.55, the claim may be accepted if the claim properly identifies the prior foreign application and is accompanied by a grantable petition under 37 CFR 1.55(e) to accept an unintentionally delayed claim for priority and the applicable petition fee under 37 CFR 1.17(m)(1) or (m)(2).
Response to Arguments
Applicant's arguments filed on March 12, 2016 with respect to the priority of instant application have been fully considered but they are not persuasive.
In Summary, applicant argues the claim amendments removes any inference that the claims are not entitled priority.
In response, applicant’s argument is not found persuasive, because the claims noted above still includes limitations that are not described in the foreign application. Therefore, the claims indicated above are not entitled to the benefit of the foreign application for the reasons set forth herein.
Action Summary
Claims 1-2, 6-7, 10-11, 15, 22, and 24 rejected under 35 U.S.C. 103 as being unpatentable over Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024), in view of Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024) and Santos et al. (Arc Clin Psychiatr, 2018. Vol. 45 (1):22-24; cited under “Other Documents”, cite no. 35 in the IDS filed on June 26, 2024), as evidenced by Nestler et al. (Elsevier Science, 2012: 53-57) and APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-11, 15, 22, and 24 rejected under 35 U.S.C. 103 as being unpatentable over Russ et al. (WO2018/195455A1), in view of Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792) and Santos et al. (Arc Clin Psychiatr, 2018. Vol. 45 (1):22-24) as applied to claims 1-2, 6-7, 10-11, 15, 22, and 24 above, and further in view of Osório et al. (Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999), 2015. Vol. 37(1): 13-20; cited in the IDS filed on June 26, 2024) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-11, 15, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Russ et al. (WO2018/195455A1), in view of Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792) and Santos et al. (Arc Clin Psychiatr, 2018. Vol. 45 (1):22-24) as applied to claims 1-2, 6-7, 10-11, 15, 22, and 24 above, and further in view of McCormack et al. (CMAJ., 2011. Vol. 183(1): 65-69) and Erowid (5-MEO-DMT dosage. The Vaults of Erowid [online]; cited under “other documents”, cite no. 90 in the IDS filed on June 26, 2024) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-41, 43, and 46-47 of copending Application No. 18/679,917 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 19-23, 29, 32-33 and 36-37 of copending Application No. 18/373,904 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 19-23, 26-27, and 30-35 of copending Application No. 18/373,903 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 50-51, 69-70, 72, 79-80 and 81-82 of copending Application No. 18/373,906 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
Claims 1-15, 22, and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 50-51, 69-72, 78, 82 and 85-86 of copending Application No. 18/373,914 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/801,389 (reference application) are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 106-108, and 110-118 of copending Application No. 18/850,376; claims 1, 9-10, 50, 56-58, 60-61, 63-68 of copending Application No. 18/850,362; claims 1, 3, 12-14, 16, and 19-26 of copending Application No. 18/850,394; claims 1, 8-11, 96, 99-103, 105, and 108-113 of copending Application No. 18/850,348; claims 1, 9-16, 100-102, 104-105, and 107-112 of copending Application No. 18/851,346; claims 1, 8-11, 100-106, and 111-112 of copending Application No. 18/851,294; claims 1, 10-14, 84-87, 89, and 94-96 of copending Application No. 18/851,301; claims 1, 9-12, 56-59, 61, 62, and 66-67 of copending Application No. 18/851,311; claims 1-6, 9-17, 19-21, 31, 33 of copending Application No. 18/851,322; claims 1, 10-14, 84-86, 88-89, and 91-96 of copending Application No. 18/850,370; claims 1, 13-16, 106-109, 111, and 116-117 of copending Application No. 18/851,362; claims 1-6, 9-11, 13-14, 16-21, 32 and 34 of copending Application No. 18/851,356; and claims 1, 13-16, 100-103, 105, and 110-111 of copending Application No. 18/851,349 are withdrawn in light of the claim amendments.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-13, 77-80, 82, 87-89 of copending Application No. 18/851,316; and claims 1, 10-13, 77-79, 81-82, and 84-89 of copending Application No. 18/850,383 are withdrawn in light of the abandonment of the copending applications.
Claims 1-4, 6-7, 10-13, 15, 22 and 24 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 12-15, 17, 22-23, 25 of copending Application No. 18/851,329 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) are withdrawn in light of the claim amendments.
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 15, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627; cited in the IDS filed on June 26, 2024), in view of Stamets (US 2019/0105313 A1) and Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited in the IDS filed on June 26, 2024).
Carhart-Harris et al. teaches patients with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”). Carhart-Harris et al. further teaches the inclusion criteria were major depression of a moderate to severe degree (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), and no improvement despite two adequate courses of antidepressant treatment of different pharmacological classes lasting at least 6 weeks within the current depressive episode (see e.g., p. 620, left column, last two lines to right column, line 5). Carhart-Harris et al. further teaches the baseline and demographic characteristics of the patients, including patient 2 shown below:
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(see e.g., Table 1). Carhart-Harris et al. further the clinician-administered ratings, including MADRS, were completed at baseline and 1 week after the high-dose session shown below:
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291
175
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(see e.g., Table 3).
Carhart-Harris et al. does not teach 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT).
Stamets teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin dephosphorylates into psilocin in the liver (see e.g., [0030]):
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197
445
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.
Stamets further teaches psilocybin and psilocin prodrugs and analogs that may similarly prove useful include those where the hydroxyl group is modified or the methyl groups of the terminal amine nitrogen have been modified (see e.g., p. 3, right column, line 9-12). Stamets further teaches preferred analogs include: analogs substituted at other positions such as, inter alia, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT); In general, equimolar amounts of an analog may be used in place of psilocybin and/or psilocin in the formulas above, or amounts producing equivalent functional effects may be utilized (see e.g., p. 3, right column, last 3 lines to p. 4, left column, line 2 and line 11-14). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches in a 5-MeO-DMT survey study, which includes respondents that used 5-MeO-DMT at least once in their lifetime (see e.g., p. 780, “procedure” section), 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration (see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3). Davis et al. further teaches current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph). Davis et al. further teaches the incidence of self-reported lifetime psychiatric disorders in this sample included depression (61%), wherein 77% of the survey respondents with depression reported improvement of their psychiatric conditions (see e.g., p. 784, right column, 1st paragraph; Table 6). Davis et al. further teaches the typical dose of 5-MeO-DMT used by the survey respondents shown as follows (see e.g., Table 3):
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.
In short, Carhart-Harris et al. teaches the administration of two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) for treating treatment-resistant major depression. The difference between the method of Carhart-Harris et al. and the claimed method is that the prior art method administers a therapeutically effective amount of psilocybin rather than the claimed 5-MeO-DMT to a subject with treatment-resistant major depression. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Carhart-Harris et al. by replacing the psilocybin with its analog as taught by Stamets et al., and selectively choose the 5-MeO-DMT taught by Davis et al. as the analog to arrive at the claimed invention. One would have been motivated to do so, because Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), may similarly prove useful for treating or improving neurological or mental health conditions comprising depression; and Davis et al. teaches the 5-MeO-DMT survey respondents with depression reported improvement of their psychiatric conditions after the administration of 5-MeO-DMT. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT , as taught by Stamets et al. and Davis et al., would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully treat treatment-resistant major depression.
Regarding the limitation of “wherein the major depressive disorder is moderate or severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more or by a 17-item Hamilton Depression Rating Scale (HAM-D) score of 17 or more” in claim 3, and the limitation of “wherein the major depressive disorder is severe major depressive disorder as indicated by a MADRS score of 35 or more or by a HAM-D score of 25 or more” in claim 4, each of these limitations is drawn to the severity of major depressive disorder. According to MPEP 2144.05 I, “[i]n 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)”. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of Carhart-Harris et al., Stamets et al. and Davis et al. set forth above for treating moderate to severe major depressive disorder with 17+ on the HAM-D scale. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), including HADM score of 28. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT, as taught by Stamets et al. and Davis et al., would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully treat moderate to severe treatment-resistant major depression with 17+ on the HAM-D scale; and that renders obvious the limitation of “a HAM-D score of 25 or more”.
Regarding the limitation of “wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via inhalation” in claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of Carhart-Harris et al., Stamets et al. and Davis et al. set forth above for set forth above for administering the 5-MeO-DMT via inhalation. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents through a smoking/vaporizing route of administration, and inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT; and therefore, one would have reasonably expected by administering the 5-MeO-DMT via inhalation would have successfully deliver said compound to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of Carhart-Harris et al., Stamets et al. and Davis et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT, as taught by Stamets et al. and Davis et al., would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of Carhart-Harris et al., Stamets et al. and Davis et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT, as taught by Stamets et al. and Davis et al., would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-4, 15, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), in view of Stamets (US 2019/0105313 A1) and Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792) as applied to claims 1, 3-4, 15, 22 and 24 above, and further in view of Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The teachings of Carhart-Harris et al., Stamets and Davis et al. are set forth above and applied as before.
Carhart-Harris et al., Stamets and Davis et al. does not teach the major depressive disorder is diagnosed in accordance with a Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association in claim 2; However, Carhart-Harris et al. teaches the patient’s general practitioner or psychiatrist provided written documentation of the patient’s diagnosis and mental health background in every case (see e.g., p. 622, right column, line 24-27).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Carhart-Harris et al., Stamets and Davis et al. set forth above to treat major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Carhart-Harris et al. teaches each and every patients with the major depression are diagnosed by general practitioner; and Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depression diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth in the method of Carhart-Harris et al., Stamets and Davis et al. above.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1, 3-4, 6-7, 15, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), in view of Stamets (US 2019/0105313 A1) and Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024) as applied to claims 1, 3-4, 15, 22 and 24 above, and further in view of Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043).
The teachings of Carhart-Harris et al., Stamets and Davis et al. are set forth above and applied as before.
Carhart-Harris et al., Stamets and Davis et al. does not teach the patient is suffering from suicidal ideation in claim 6. Carhart-Harris et al., Stamets and Davis et al. also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7; However, Carhart-Harris et al. teaches data obtained from large-scale population studies have recently challenged the view that psychedelics negatively affect mental health, with one study’s findings showing lower rates of psychological distress and suicidality among people who had used psychedelics within their lifetime than among those who used no psychedelics but an equivalent amount of other drugs (see e.g., p. 619, right column, line 12 to p. 20, left column, line 3).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Carhart-Harris et al., Stamets and Davis et al. set forth above to treat the patient with suicidal thinking, including those with suicidal planning, to arrive at the claimed invention. One would have been motivated to do so, because Carhart-Harris et al. teaches the lifetime use of psychedelics lower rates of psychological distress and suicidality; and Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking, past year suicidal planning, and past year suicide attempt, which hold promise as an innovative mental health intervention and suicide prophylaxis. One would have reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT, as taught by Stamets et al. and Davis et al., would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully treat the patient suffering from suicidal ideation, including those with suicidal planning; and that renders obvious the limitation of “suicidal ideation with intent to act”.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the rejection of claims 1-2, 6-7, 10-11, 15, 22, and 24 under 35 U.S.C. 103 as being unpatentable over Russ et al. (WO2018/195455A1), in view of Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792) and Santos et al. (Arc Clin Psychiatr, 2018. Vol. 45 (1):22-24), as evidenced by Nestler et al. (Elsevier Science, 2012: 53-57) and APA Dictionary of Psychology ([online]. Published on April 14, 2018); claims 1-4, 6-7, 10-11, 15, 22, and 24 under 35 U.S.C. 103 as being unpatentable over Russ et al., in view of Davis et al., and Santos et al. as applied to claims 1-2, 6-7, 10-11, 15, 22, and 24 above, and further in view of Osório et al. (Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999), 2015. Vol. 37(1): 13-20); and claims 1-4, 6-7, 10-11, 15, 22, and 24 under 35 U.S.C. 103 as being unpatentable over Russ et al., in view of Davis et al. and Santos et al. as applied to claims 1-2, 6-7, 10-11, 15, 22, and 24 above, and further in view of McCormack et al. (CMAJ., 2011. Vol. 183(1): 65-69) and Erowid (5-MEO-DMT dosage. The Vaults of Erowid [online]) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-38, and 46-47 of copending Application No. 18/679,917 (reference application), in view of Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), and Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application is also drawn to a method that administers the same compound (a therapeutically effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof) to the subject that overlaps in scope with the instant claims (a patient diagnosed with treatment-resistant form of major depressive disorder; and the major depressive disorder is diagnosed in accordance with DSM-5 published by the American Psychiatric Association). It is noted that the reference application administers said 5-MeO-DMT via intravenous, intramuscular or subcutaneous route. The claims of the reference application also teaches the patient suffers from moderate or severe major depressive disorder as indicated by the same MADRS score and HAM-D score. The claims of reference application also teaches the same clinical response as assessed by the MADRS and HAM-D score. Please see the reference claims indicated in the statement above.
The difference between the method of the reference application and the claimed method is that the reference application does not teach the 5-MeO-DMT is administered via inhalation in claim 15. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7.
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method as set forth in the claims of the reference application to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis; and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT , as taught by Stamets et al. and Davis et al., would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully treat patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of reference application set forth above by replacing the intravenous, intramuscular, or subcutaneous route with inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT over injection; and therefore, one would have reasonably expected by replacing the intravenous, intramuscular, or subcutaneous route with inhalation would have successfully deliver 5-MeO-DMT to the patient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of claims 1-4, 6-7, 10-13, 15, 22 and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 34-41, 43, and 46-47 of copending Application No. 18/679,917 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) have been fully considered.
In Summary, applicant argues the pending claims are patentably distinct, because the claim amendments overcomes the provisional non-statutory double patenting rejection(s).
In response, Applicant’s argument is not found persuasive. This assertion appears to be applicant’s argument without any supporting evidence. The claims of the reference application clearly administer the same compound (a therapeutically effective amount of 5-MeO-DMT) to the subject that overlaps in scope with the claimed invention (a patient diagnosed with a treatment-resistant form of major depressive disorder). In the absence of unexpected results, by practicing the method of reference application, the major depressive disorder would necessarily be treated.
Therefore, the rejection has been reconsidered, but revisited and modified in light of the claim amendments.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9 of copending Application No. 18/373,904 (referred to herein as “’904”); and over claims 1-5, 9 and 32-35 of copending Application No. 18/373,903 (referred to herein as “’903”), in view of Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of each reference application are drawn to a method that administers the same compound (an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof) to the patient that overlaps in scope with the instant application (a patient suffers from postpartum depression and moderate or severe depression and from compromised or severely comprised maternal functioning); wherein the patients is in remission of depressive symptoms on day 7. Please note the claimed term “postpartum depression (PPD)” refers to a major depressive disorder with peripartum onset according to the definition set forth in the reference application(s); therefore, the patient of the reference application is a patient who is diagnosed with major depressive disorder. Please see the reference claims indicated in the statement above.
The difference between each of these reference application is that the ‘904 application teaches the administration via intravenous, intramuscular, or subcutaneous route; and the ‘903 application teaches the administration via inhalation.
The difference between the method of reference application and the claimed method is that the claims of reference application does not teach the patient is suffering from a treatment-resistant form of major depressive disorder. The claims of reference application also does not teach the patient is diagnosed in accordance with DSM-5 as claimed in claim 2. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The claims of ‘903 application does not teach the 5-MeO-DMT is administered via inhalation as claimed in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the method of each reference application and the claimed invention is that the reference application does not teach treatment-resistant form of major depressive disorder. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method set forth in the claims of each reference application to incorporate the patient suffering from a treatment-resistant form of major depressive disorder as the postpartum depression (a major depressive disorder with peripartum onset), as taught by Carhart-Harris et al. and Stamets, to arrive at the claimed invention. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder as the postpartum depression; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of each reference application, Carhart-Harris and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with postpartum depression (a major depressive disorder with peripartum onset), in which the major depressive disorder is diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association, would reasonably be treated by administering the 5-MeO-DMT set forth in the above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of each reference application, Carhart-Harris and Stamets set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the 5-MeO-DMT, which is a psilocybin analog, would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of ‘904 application, Carhart-Harris and Stamets set forth above by replacing the intravenous, intramuscular, or subcutaneous route with inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT over injection; and therefore, one would have reasonably expected by replacing the intravenous, intramuscular, or subcutaneous route with inhalation would have successfully deliver 5-MeO-DMT to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of each reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT of the reference application would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of each reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT of the reference application would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of
claims 1-4, 6-7, 10-13, 15, 22 and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 19-23, 29, 32-33 and 36-37 of copending Application No. 18/373,904 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) have been fully considered.
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of claims 1-4, 6-7, 10-13, 15, 22 and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 19-23, 26-27, and 30-35 of copending Application No. 18/373,903 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) have been fully considered.
In Summary, applicant argues the pending claims are patentably distinct, because the claim amendments overcomes the provisional non-statutory double patenting rejection(s).
In response, Applicant’s argument is not found persuasive. This assertion appears to be applicant’s argument without any supporting evidence. Therefore, the rejection has been reconsidered, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 50-51, and 81-84 of copending Application No. 18/373,906 (referred to herein as “’906”); over claims 1 and 49-51 of copending Application No. 18/373,914 (referred to herein as “’914”), in view of Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of each of these reference applications are drawn to a method of treating a breastfeeding mother suffers from postpartum depression (PPD) as the mental or nervous system disorder, comprising administering to said mother the same compound (an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof); wherein a remission of depressive symptoms, as assessed by the same MADRS and HAM-D score, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Please note the claimed term “postpartum depression (PPD)” refers to a major depressive disorder with peripartum onset according to the definition set forth in the reference application. Please see the reference claims indicated in the statement above.
The difference between each of these reference application is that the ‘914 application teaches the administration via intravenous, intramuscular, or subcutaneous route; and the ‘906 application teaches the administration via inhalation.
The claims of reference application do not teach the patient is suffering from a treatment-resistant form of major depressive disorder. The claims of reference application also do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The claims of ‘914 application does not teach the 5-MeO-DMT is administered via inhalation in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the method of each reference application and the claimed invention is that the reference application does not teach treatment-resistant form of major depressive disorder, and moderate or severe major depressive disorder. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method set forth in the claims of each reference application to incorporate the patient suffering from a treatment-resistant form of major depressive disorder as the postpartum depression (a major depressive disorder with peripartum onset), including moderate or severe major depressive disorder, as taught by Carhart-Harris et al. and Stamets to arrive at the claimed invention. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder as the postpartum depression; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of each reference application, Carhart-Harris and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with postpartum depression (a major depressive disorder with peripartum onset), in which the major depressive disorder is diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association, would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of each reference application, Carhart-Harris and Stamets set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the 5-MeO-DMT, which is a psilocybin analog, would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of ‘914 application, Carhart-Harris and Stamets set forth above by replacing the intravenous, intramuscular, or subcutaneous route with inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT over injection; and therefore, one would have reasonably expected by replacing the intravenous, intramuscular, or subcutaneous route with inhalation would have successfully deliver 5-MeO-DMT to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of each reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT of the reference application would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of each reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT of the reference application would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of
claims 1-4, 6-7, 10-13, 15, 22 and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 50-51, 69-70, 72, 79-80 and 81-82 of copending Application No. 18/373,906 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) have been fully considered.
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of claims 1-15, 22, and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 50-51, 69-72, 78, 82 and 85-86 of copending Application No. 18/373,914 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) have been fully considered.
In Summary, applicant argues the pending claims are patentably distinct, because the claim amendments overcomes the provisional non-statutory double patenting rejection(s).
In response, Applicant’s argument is not found persuasive. This assertion appears to be applicant’s argument without any supporting evidence. Therefore, the rejection has been reconsidered, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24 and 35-36 of copending Application No. 17/801,389 (reference application), in view of Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of reference application is drawn to a method of treating major depressive disorder in a patient comprising administering a pharmaceutical aerosol to the patient, the pharmaceutical aerosol comprising, inter alia, aerosol particles of 5-MeO-DMT freebase and/or pharmaceutical aerosol, wherein, inter alia, the pharmaceutical aerosol is configured for treating a human patient having the major depressive disorder.
The claims of reference application do not teach the patient is suffering from a treatment-resistant form of major depressive disorder. The claims of reference application also do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The claims of ‘914 application does not teach the 5-MeO-DMT is administered via inhalation in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the method of reference application and the claimed invention is that the reference application does not teach treatment-resistant form of major depressive disorder, and moderate or severe major depressive disorder. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method set forth in the claims of reference application to incorporate the patient suffering from a treatment-resistant form of major depressive disorder as the major depressive disorder. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering the pharmaceutical aerosol comprising aerosol particles of 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder as the major depressive disorder; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the pharmaceutical aerosol set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the pharmaceutical aerosol comprising the 5-MeO-DMT, which is a psilocybin analog, would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the pharmaceutical aerosol comprising the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the pharmaceutical aerosol comprising a therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the pharmaceutical aerosol comprising the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering the pharmaceutical aerosol comprising a therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of
claims 1-4, 6-7, 10-13, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/801,389 (reference application) have been fully considered.
In Summary, applicant argues the pending claims are patentably distinct, because the claim amendments overcomes the provisional non-statutory double patenting rejection(s).
In response, Applicant’s argument is not found persuasive. This assertion appears to be applicant’s argument without any supporting evidence. Therefore, the rejection has been reconsidered, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 120, 126-127, 131 and 147 of copending Application No. 18/850,376 (referred to herein as “‘376”); claims 70, 76-77, 81, 97 of copending Application No. 18/850,362 (referred to herein as “’362”); claims 33, 35, 58 and 60-61 of copending Application No. 18/850,394 (referred to herein as “’394”); claims 115-121, 125 and 141 of copending Application No. 18/850,348 (referred to herein as “’348”); claims 114-120, 124 and 135 of copending Application No. 18/851,294 (referred to herein as “’294”); claims 97, 106-112 and 123 of copending Application No. 18/851,301 (referred to herein as “’301”); claims 98, 107-111, 112 and 125 of copending Application No. 18/850,370 (referred to herein as “’370”; and claims 119, 121-126, 130 and 141 of copending Application No. 18/851,362 (referred to herein as “’362”), in view of Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of each of these reference application are drawn to a method comprising administering the same compound (an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof to the patient that overlaps in scope with the instant application (a patient is also suffering from major depressive disorder, and the patient suffers from a treatment resistant form of the disorder), wherein the treatments leads to an improvement in the disorder in a patient. Please see the reference claims indicated in the statement above.
The difference between each of these reference application is that the ‘294, ‘301, and ‘141 applications teach the administration via intravenous injection; and the ‘376, ‘362, ‘394, ‘348 and ‘370 applications teach the administration via inhalation.
The claims of reference application do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The claims of ‘294, ‘301, and ‘141 application does not teach the 5-MeO-DMT is administered via inhalation in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the method of each of these reference applications and the claimed invention is that the reference application does not teach moderate or severe major depressive disorder. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method set forth in the claims of reference application to incorporate moderate or severe major depressive disorder as the major depressive disorder. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the administration of psilocybin analog 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder as the major depressive disorder; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of each of the 294, ‘301, and ‘141 applications, Carhart-Harris and Stamets set forth above by replacing the intravenous injection with inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT over injection; and therefore, one would have reasonably expected by replacing the intravenous injection with inhalation would have successfully deliver 5-MeO-DMT to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that a therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-55, 70 and 76 of copending Application No. 18/851,322; and claims 78-85, 100 and 106 of copending Application No. 18/851,356, in view of Stamets (US 2019/0105313 A1), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of each of these reference applications are drawn to a method comprising administering the same compound (an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof) via inhalation to the patient that overlaps in scope with the instant application (a patient is suffering from treatment resistant form of postpartum depression; wherein the patient has a MADRS score 20 or more, 28 or more, or 35 or more; the patient has HAM-D score 16 or more, 22 or more, or 27 or more). Please note the claimed term “postpartum depression (PPD)” is major depressive disorder with peripartum. The claims of reference application also teaches the same clinical response as assessed by the MADRS and HAM-D score. Please see the reference claims indicated in the statement above.
The claims of reference application do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7.
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis; and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, and the limitation of “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. The method of the reference application renders obvious the limitation(s) instantly claimed, because by administering the same compound (an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof) via inhalation to the same patient (a patient is suffering from treatment resistant form of postpartum depression, which is a major depressive disorder with peripartum onset; wherein the patient has a MADRS score 20 or more, 28 or more, or 35 or more; the patient has HAM-D score 16 or more, 22 or more, or 27 or more) would necessarily treat the major depressive disorder by presenting the same clinical response, even though the copending applications are not aware of it.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-16, and 109-112 of copending Application No. 18/851,346; claims 1, 9-12, 56-59, 61, 62, and 66-67 of copending Application No. 18/851,311; and claims 1, 13-16, 100-103, 105, and 110-111 of copending Application No. 18/851,349.
Please note the claim language of “5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use” in the claims of each reference application is interpreted by the Examiner as being drawn to a compound that is 5-MeO-DMT or a pharmaceutically acceptable salt thereof with an intended use.
The claims of each reference application teach the same compound (5-MeO-DMT or a pharmaceutically acceptable salt thereof) is useful for the same patient (patient suffering treatment resistant form of major depressive disorder); wherein the 5-MeO DMT or a pharmaceutical acceptable salt thereof is administered via inhalation. Please see reference claims for each reference application as indicated in the statement above.
The conflicting claims of each reference applications are drawn to a compound (“5-MeO-DMT or a pharmaceutically acceptable salt thereof”), the claims and the specification of these reference applications also disclose the utility of the recited compounds as covered by the instant methods of using the compounds, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
Please note “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the provisional rejection of claims 1-4, 6-7, 10-13, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 106-108, and 110-118 of copending Application No. 18/850,376; claims 1, 9-10, 50, 56-58, 60-61, 63-68 of copending Application No. 18/850,362; claims 1, 3, 12-14, 16, and 19-26 of copending Application No. 18/850,394; claims 1, 8-11, 96, 99-103, 105, and 108-113 of copending Application No. 18/850,348; claims 1, 9-16, 100-102, 104-105, and 107-112 of copending Application No. 18/851,346; claims 1, 8-11, 100-106, and 111-112 of copending Application No. 18/851,294; claims 1, 10-14, 84-87, 89, and 94-96 of copending Application No. 18/851,301; claims 1, 9-12, 56-59, 61, 62, and 66-67 of copending Application No. 18/851,311; claims 1-6, 9-17, 19-21, 31, 33 of copending Application No. 18/851,322; claims 1, 10-14, 84-86, 88-89, and 91-96 of copending Application No. 18/850,370; claims 1, 13-16, 106-109, 111, and 116-117 of copending Application No. 18/85,1362; claims 1-6, 9-11, 13-14, 16-21, 32 and 34 of copending Application No. 18/851,356; and claims 1, 13-16, 100-103, 105, and 110-111 of copending Application No. 18/851,349 have been fully considered.
All provisional rejections pertaining to claims 1-4, 6-7, 10-13, 15, 22 and 24 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-13, 77-80, 82, 87-89 of copending Application No. 18/851,316; and claims 1, 10-13, 77-79, 81-82, and 84-89 of copending Application No. 18/850,383 are moot in light of the abandonment of the copending applications.
In Summary, applicant argues the pending claims are patentably distinct, because the claim amendments overcomes the provisional non-statutory double patenting rejection(s).
In response, Applicant’s argument is not found persuasive. This assertion appears to be applicant’s argument without any supporting evidence. Therefore, the rejection has been reconsidered, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33, 35 and 54-55 of copending Application No. 18/851,329 (reference application), in view of Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of the reference application are directed to a method for treating a mental or nervous system disorder, including major depressive disorder, that administer the same compound (an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof) via the intravenous, intramuscular or subcutaneous routes to the subject that overlaps in scope with the instant application (a breastfeeding mother suffers from a treatment resistant form of the mental or nervous system disorder, including major depressive disorder). Please see the reference claims indicated in the statement above.
The reference application do not teach the patient is diagnosed in accordance with DSM-5 as claimed in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The reference application do not teach the 5-MeO-DMT is administered via inhalation as claimed in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the method of each of these reference applications and the claimed invention is that the reference application does not teach moderate or severe major depressive disorder. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method set forth in the claims of reference application to incorporate moderate or severe major depressive disorder as the major depressive disorder. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the administration of psilocybin analog 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder as the major depressive disorder; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris and Stamets set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of each of the reference applications, Carhart-Harris and Stamets set forth above by replacing the intravenous route with inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT over injection; and therefore, one would have reasonably expected by replacing the intravenous route with inhalation would have successfully deliver 5-MeO-DMT to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on March 12, 2026 with respect to the rejection of claims 1-4, 6-7, 10-13, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 12-15, 17, 22-23, 25 of copending Application No. 18/851,329 (reference application), in view of Russ et al. (WO2018/195455A1; cited under “foreign patent documents”, cited letter a in the IDS filed on June 26, 2024) and Carhart-Harris (The Lancet Psychiatry, 2016. Vol. 3(7): 619-627; cited under “other documents”, cited no. 45 in the IDS filed on June 26, 2024), as evidenced by APA Dictionary of Psychology ([online]. Published on April 14, 2018) have been fully considered.
In response, Applicant’s argument is not found persuasive. This assertion appears to be applicant’s argument without any supporting evidence. Therefore, the rejection has been reconsidered, but revisited and modified in light of the claim amendments for the reasons set forth herein.
Claims 1-4, 6-7, 15, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,172,960 B2 in view of Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of the reference patent is drawn to a hydrobromide salt of 5-MeO-DMT in crystalline form; and a pharmaceutical composition comprising said salt.
The claims of reference application do not teach administering a therapeutically effective amount of the salt to a patient suffering from a treatment-resistant form of major depressive disorder. The claims of reference application also do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The claims of ‘914 application does not teach the 5-MeO-DMT is administered via inhalation in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches also preferred, where possible, are the salts of the tryptamine compounds, for example hydrochloride, fumarate, maleate, picrate, oxalate, tartrate and sulfate salts, which are typically more stable (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the reference patent and the claimed invention is that the reference application is drawn to a hydrobromide salt of 5-MeO-DMT whereas the instant application is drawn to a method of use. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to administer the hydrobromide salt of 5-MeO-DMT of reference patent at a therapeutically effective amount for treating treatment-resistant form of major depressive disorder, including moderate or severe major depressive disorder, to arrive at the claimed invention. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT and salts of the tryptamine compounds, may be similarly useful for treating or improving neurological or mental health conditions comprising depression; and Davis et al. teaches the 5-MeO-DMT survey respondents with depression reported improvement of their psychiatric conditions after the administration of 5-MeO-DMT. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering the hydrobromide salt of 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference patent, Carhart-Harris, Stamets and Davis et al. set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference patent, Carhart-Harris, Stamets and Davis et al. set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog, hydrobromide salt of 5-MeO-DMT, would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of reference patent, Carhart-Harris, Stamets and Davis et al. set forth above to administer the 5-MeO-DMT via inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering the 5-MeO-DMT; and therefore, one would have reasonably expected by administering the hydrobromide salt of 5-MeO-DMT via inhalation would have successfully deliver 5-MeO-DMT to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference patent, Carhart-Harris et al., Stamets et al. and Davis et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog, hydrobromide salt of 5-MeO-DMT, would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of a hydrobromide salt of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference patent, Carhart-Harris et al., Stamets et al. and Davis et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog, hydrobromide salt of 5-MeO-DMT, would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of hydrobromide salt of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/920,063 (reference application), in view Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Davis et al. (J Psychopharmacol, 2018. Vol. 32(7): 779-792; cited under “other documents”, cite no. 69 in the IDS filed on June 26, 2024), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of the reference application is drawn to a hydrobromide salt of 5-MeO-DMT in crystalline form; and a pharmaceutical composition comprising said salt.
The claims of reference application do not teach administering a therapeutically effective amount of the salt to a patient suffering from a treatment-resistant form of major depressive disorder. The claims of reference application also do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7. The claims of ‘914 application does not teach the 5-MeO-DMT is administered via inhalation in claim 15.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches also preferred, where possible, are the salts of the tryptamine compounds, for example hydrochloride, fumarate, maleate, picrate, oxalate, tartrate and sulfate salts, which are typically more stable (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Davis et al. teaches 81% of survey respondents had consumed 5-MeO-DMT through a smoking/vaporizing route of administration, and 3% using other route (e.g., injected, sublingual, rectal)(see e.g., p. 783, left column, 1st paragraph under Table 2; Table 3); and current unpublished reports of 5-MeO-DMT use describe inhalation (e.g., smoking or vaporizing) as a common means of consumption (see e.g., p. 780, left column, 3rd paragraph).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the reference application and the claimed invention is that the reference application is drawn to a hydrobromide salt of 5-MeO-DMT whereas the instant application is drawn to a method of use. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to administer the hydrobromide salt of 5-MeO-DMT of reference application at a therapeutically effective amount for treating treatment-resistant form of major depressive disorder, including moderate or severe major depressive disorder, to arrive at the claimed invention. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT and salts of the tryptamine compounds, may be similarly useful for treating or improving neurological or mental health conditions comprising depression; and Davis et al. teaches the 5-MeO-DMT survey respondents with depression reported improvement of their psychiatric conditions after the administration of 5-MeO-DMT. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering the hydrobromide salt of 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris, Stamets and Davis et al. set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris, Stamets and Davis et al. set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog, hydrobromide salt of 5-MeO-DMT, would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding claim 15, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the method of reference application, Carhart-Harris, Stamets and Davis et al. set forth above to administer the 5-MeO-DMT via inhalation to arrive at the claimed invention. One would have been motivated to do so, because Davis et al. teaches 81% of the 5-MeO-DMT survey respondents consumed 5-MeO-DMT through a smoking/vaporizing route of administration whereas 3% consumed it via other routes (e.g., injected); and further teaches inhalation (e.g., smoking or vaporizing) is a common means of 5-MeO-DMT consumption. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that inhalation is the most common route of administering 5-MeO-DMT; and therefore, one would have reasonably expected by administering the hydrobromide salt of 5-MeO-DMT via inhalation would have successfully deliver 5-MeO-DMT to the patient.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., Stamets et al. and Davis et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog, hydrobromide salt of 5-MeO-DMT, would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of a hydrobromide salt of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., Stamets et al. and Davis et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog, hydrobromide salt of 5-MeO-DMT, would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of hydrobromide salt of 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-7, 15, 22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-30 of copending Application No. 19/573,936 (reference application), in view Carhart-Harris et al. (The Lancet Psychiatry, 2016. Vol. 3: 619-627), Stamets (US 2019/0105313 A1), Hendricks et al. (J Psychopharmacol. 2015;29(9):1041-1043), and Tolentino et al. (Front Psychiatry, 2018. Vol. 9: 450).
The claims of the reference application is drawn to a method of treating major depressive disorder (MDD), the method comprising administering to the same patient (a patient diagnosed with major depressive with major depressive disorder; wherein the patient suffers from a treatment resistant form of major depressive disorder) a pharmaceutical aerosol comprising the same compound (a therapeutically effective amount of aerosol particles of 5-MeO-DMT and/or a pharmaceutically acceptable salt thereof); wherein clinical remission with the same MADRS score is achieved at least days from the administration.
The claims of reference application also do not teach the patient is diagnosed in accordance with DSM-5 in claim 2. The claims of reference application also do not teach the patient is suffer from the moderate or severe major depressive disorder in claims 3-4. The reference application also does not teach the patient is suffering from suicidal ideation in claim 6. The reference application also does not teach the patient is suffering from suicidal ideation with intent to act or wherein the patient is at imminent risk for suicide in claim 7.
Carhart-Harris et al. teaches patients with moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), unipolar, treatment-resistant major depression received two oral doses of psilocybin (a low oral dose of psilocybin 10 mg on a first dosing day and a high oral dose of psilocybin 25 mg on a second dosing day, separated by 1 week), and the depressive symptoms relative to baseline were markedly reduced 1 week and 3 after high-dose treatment (see e.g., p. 621, right column, last paragraph; abstract, “methods”; p.620, left column, last two lines to right column, line 5). Carhart-Harris further teaches the mean MADRS score decreased from a baseline of 31.0 to 9.7 at 1 week post-treatment (see e.g., Table 3).
Stamets further teaches a method for treating or improving neurological or mental health conditions comprising administration of an effective amount of a composition comprising psilocybin or psilocin to a subject in need thereof, where the neurological or mental health conditions comprise, inter alia, depression (see e.g., claims 1 and 4-5). Stamets further teaches psilocybin and psilocin prodrugs and analogs (compounds having a structure similar to another, but differing from it in respect of a certain substituent in which one or more atoms or functional groups which are replaced with other atoms or groups or substituents) that may similarly prove useful, including 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) (see e.g., [0018]). Stamets further teaches also preferred, where possible, are the salts of the tryptamine compounds, for example hydrochloride, fumarate, maleate, picrate, oxalate, tartrate and sulfate salts, which are typically more stable (see e.g., [0018]). Stamets further teaches formulating a composition into a dosage form comprising, inter alia, inhalers (see e.g., [0021]).
Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past month psychological distress, past year suicidal thinking, past year suicidal planning, and past year suicide attempt in the United States adult population (see e.g., p. 1, line1-7 and line 16-20; Table 1). Hendricks et al. further teaches psilocybin in particular may thus hold promise as an innovative mental health intervention and suicide prophylaxis (see e.g., p. 3, line 25-26).
Tolentino et al. teaches depression diagnosis requires five or more symptoms (Diagnostic and Statistical Manual of Mental Disorders-DSM-5) (see e.g., abstract). Tolentino et al. further teaches according to the DSM-5 criteria, the symptoms are summed to determine the presence or the absence of a major depression episode by citing the Diagnostic and Statistical Manual of Mental Disorders, 5th edition published by American Psychiatric Association (see e.g., p. 2, left column, 2nd paragraph; p. 7, reference 4).
In the instant case, the difference between the method of the reference applications and the claimed invention is that the reference application does not teach moderate or severe major depressive disorder. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method set forth in the claims of reference application to incorporate moderate or severe major depressive disorder as the major depressive disorder. One would have been motivated to do so, because Carhart-Harris et al. teaches psilocybin treats moderate-to-severe treatment-resistant major depression (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]); and Stamets teaches psilocybin and psilocin prodrugs and analogs, including 5-MeO-DMT, may be similarly useful for treating or improving neurological or mental health conditions comprising depression. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the administration of psilocybin analog 5-MeO-DMT at a therapeutically effective amount would have successfully exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al. for treating moderate-to-severe (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]) treatment-resistant form of major depressive disorder as the major depressive disorder; and thar renders obvious the limitation(s) in claim 3-4.
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris et al., and Stamets set forth above to incorporate the major depressive disorder diagnosed by general practitioner using the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) published by the American Psychiatric Association as taught by Tolentino et al. to arrive at the claimed invention. One would have been motivated to do so, because Tolentino et al. teaches depression diagnosis requires five or more symptoms to determine the presence or the absence of a major depression episode according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) published by American Psychiatric Association. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the patient with major depressive disorder diagnosed by a general practitioner using the DSM-5 published by American Psychiatric Association would reasonably be treated by administering the 5-MeO-DMT set forth above.
Regarding claims 6-7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of reference application, Carhart-Harris et al., and Stamets set forth above to treat the patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act, to arrive at the claimed invention. One would have been motivated to do so, because Hendricks et al. teaches lifetime psilocybin use reduces likelihood of past year suicidal thinking and past year suicidal planning thus hold promise as an innovative mental health intervention and suicide prophylaxis. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar suicide prophylaxis effect as the psilocybin taught by Hendricks et al. for treating a patient suffering from suicidal ideation, including the patient suffering from suicidal ideation with intent to act.
Regarding the limitation of “wherein a clinical response, as assessed by at least 50% improvement of a MADRS… compared to a respective score prior to the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof, is observed on the 6th day or later after the administration of the 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 22, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al., and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a baseline MADRS of 31.0 and MADRS of 9.7 at 1 week after the last dose of psilocybin. Please note the percentage improvement can be calculated using the MADRS score observed 1 week after the administration of psilocybin and the baseline MADRS score, which when calculated by
100
%
-
9.7
31.0
×
100
%
=
68.71
%
, gives 68.1% improvement of the MADRS score on day 7; and that lies within the claimed range of “at least 50% improvement”. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of the 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
With respect to “wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10…, on day 7 or later after the administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof” in claim 24, the claimed limitation is drawn to the intended result or outcome of the method steps positively recited. According to MPEP 2144.05 I, “[i]n 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)”. The method of reference application, Carhart-Harris et al. and Stamets et al. set forth above renders obvious the claimed limitation, because Carhart-Harris et al. teaches the patients with treatment-resistant major depression treated with two oral doses of psilocybin has a MADRS of 9.7 at 1 week after the last dose of psilocybin. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the psilocybin analog 5-MeO-DMT would have exerted the same or substantially similar antidepressant effect as the psilocybin taught by Carhart-Harris et al.; and therefore, one would have reasonably expected that administering a therapeutically effective amount of the 5-MeO-DMT can successfully improves a clinical response assessed by MADRS score similar to the psilocybin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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