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 .
Claim Objections
Claims 33-39 are objected to because of the following informalities: on the 1st line of each of claims 33-39, applicant need to change “a psychiatric” to --- the psychiatric --- . Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 32, 33, 36-38, 40-42, 61, 65 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1).
Londesbrough teaches (claims 1, 2, 5 and 6) a method of treating an anxiety disorder, such as generalized anxiety disorder (GAD), social anxiety disorder, obsessive-compulsive disorder (OCD), in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of psilocybin (instant 5-HT2A receptor agonist – see pg.36, lines 19-24) or an active metabolite thereof. Londesbrough further teaches (pg.70, lines 14-18) that the subject with an anxiety disorder is administered at least one additional therapeutic, prior to, after or concurrently with psilocybin. Londesbrough teaches (pg.70, lines 25-26) that the additional therapy can be a N-methyl-DI-aspartate (NMDA) receptor antagonist, such as ketamine (instant NMDA receptor antagonist of claim 61). Thus, it would be obvious to one skilled in the art to administer to the subject a therapeutically effective amount of psilocybin (or an active metabolite thereof) with a NMDA receptor antagonist (prior to, after or concurrently with psilocybin) with a reasonable expectation of treating an anxiety disorder, such as generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder.
Thus, Londesbrough renders obvious instant claims 32, 33, 36, 37, 38 and 61.
With respect to instant claim 40, as discussed above, Londesbrough teaches administering psilocybin or an active metabolite thereof. Londesbrough further teaches (pg.64, lines 1-3) that the active metabolite is psilocin. According to Londesbrough’s teaching, it would be obvious to one skilled in the art to administer psilocin together with a NMDA receptor antagonist with a reasonable expectation of success. Psilocin has the following chemical structure (as obtained from the Wikipedia website: https://en.wikipedia.org/wiki/Psilocin):
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, and its meets instant Formula (I) of claim 40 (instant R9 and R10 are -CH3 (unsubstituted alkyl); instant Y1, Y2, X1, X2 are hydrogen atoms; R2, R5, R6 and R7 are hydrogen atoms; and R4 is hydroxyl). Thus, Londesbrough renders obvious instant claim 40.
With respect to instant claim 41, Londesbrough teaches (pg.126, item nos. 67-76) that at least one dose of psilocybin can be administered over a period of anywhere from a day or up to 12 months. Since Londesbrough teaches administering psilocybin with a NMDA receptor antagonist (prior to, after or concurrently with psilocybin), It would be obvious to one skilled in the art to administer at least one dose of psilocybin together with a NMDA receptor antagonist (prior to, after or concurrently with psilocybin) over a period of from a day or up to 12 months as taught by Londesbrough. Thus, Londesbrough renders obvious instant claim 41.
With respect to instant claims 42, 65 and 66 (pg.163, item no.36), as already discussed above, Londesbrough teaches that the NMDA receptor antagonist can be taken prior to, after or concurrently with psilocybin. This means that (i) If the NMDA receptor antagonist is taken prior to or after psilocybin, psilocybin (instant 5-HT2A receptor agonist) and the NMDA receptor antagonist would have to be administered sequentially as separate pharmaceutical compositions (thus teaching instant limitation of claim 65). Or, (ii) if the NMDA receptor antagonist is taken concurrently with psilocybin (instant 5-HT2A receptor agonist), this means that psilocybin and the NMDA receptor antagonist would have be administered concurrently either as separate pharmaceutical compositions (thus teaching instant limitation of claim 66) or as a single pharmaceutical composition (thus teaching instant limitation of claim 42). Since Londesbrough teaches the equivalence of taking NMDA receptor antagonist prior to , after or concurrently with psilocybin, Londesbrough renders obvious all the limitations of claims 42, 65 and 66. Thus, Londesbrough renders obvious instant claims 42, 65 and 66.
Claim(s) 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of McGowan et al (US 2020/0261379 A1).
Londesbrough does not explicitly teach that its psilocybin administered together with a NMDA receptor antagonist (the NMDA receptor antagonist taken prior to, after or concurrently with psilocybin) can be used to treat a major depressive disorder (MDD) or treatment-resistant depression (TRD). However, as discussed above, Londesbrough teaches (pg.70, lines 25-26) that the NMDA receptor antagonist can be ketamine, and it is known in the art, as evidenced by McGowan et al (see [0005]), that NMDA receptor antagonist, such as ketamine, has been shown to have rapid acting antidepressant effects in treatment-resistant MDD and TRD. Since Londesbrough teaches that its NMDA receptor antagonist can be ketamine, it would have been obvious to one skilled in the art to administer psilocybin with a NMDA receptor antagonist (ketamine) to a subject in need thereof to treat MDD and TRD with a reasonable expectation of success. Thus, Londesbrough in view of McGowan render obvious instant claims 34 and 35.
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Bisaga et al (“Therapeutic potential of NMDA receptor antagonists in the treatment of alcohol and substance use disorders”, Expert Opinion on Investigational Drugs, (Feb. 2005) vol.9(10), pg.2233-2248, obtained from the website: https://www.tandfonline.com/doi/10.1517/13543784.9.10.2233?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed ).
Londesbrough does not explicitly teach that its psilocybin administered together with a NMDA receptor antagonist can be used to treat alcohol use disorder. However, as evidenced by Bisaga et al (see abstract), a substantial amount of research supports the therapeutic potential use of NMDA receptor antagonists in alcohol and substance use disorders. Thus, it would have been obvious to one skilled in the art to administer Londesbrough’s psilocybin with a NMDA receptor antagonist to a subject in need thereof to treat alcohol use disorders with a reasonable expectation of success. Thus, Londesbrough in view of Bisaga renders obvious instant claim 39.
Claim(s) 30, 31, 43, 44, 48, 49 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Nagele et al (“Exploring Nitrous Oxide as Treatment for Mood Disorders: Basic Concepts”, J Clin Psychopharmacol. Apr 2018, vol.38(2), pg.144-148).
With respect to instant claim 67, Londesbrough teaches (pg.43, lines 19-20) that its psilocybin can be administered intravenously. Londesbrough does not teach that its NMDA receptor antagonist (such as ketamine) is administered via inhalation. Nagele teaches (see the paragraph following the abstract) the NMDA receptor antagonist, nitrous oxide, shows great promise like ketamine in treating treatment-resistant major depression. Nagele further teaches (see the 2nd and 3rd paragraphs under “Known side effects of nitrous oxide” on pg.4) that unlike ketamine, nitrous oxide does not cause hallucinations, delusions or other psychotomimetic side effects. Most of the side effects are of brief duration and dissipate after discontinuation of nitrous oxide. It would be obvious to one skilled in the art to use nitrous oxide (instead of ketamine) as the NMDA receptor antagonist (which is to be administered prior to, after or concurrently with psilocybin) with a reasonable expectation of treating treatment-resistant major depression while reducing hallucinations, delusions or other psychotomimetic side effects, as taught by Nagele. Nagele further teaches (pg.2, 3rd paragraph and pg.3, 1st paragraph) that nitrous oxide is a gas and is administered by inhalation. Thus, It would be obvious to one skilled in the art to administer psilocybin (5-HT2A receptor agonist) intravenously and administer nitrous oxide via inhalation (prior to, after or concurrently with psilocybin) with a reasonable expectation of success. Thus, Londesbrough in view of Nagele renders obvious instant claim 67.
With respect to instant claims 43, 48 and 49, Londesbrough teaches (pg.43, lines 19-24) that its psilocybin (5-HT2A receptor agonist) can be administered by inhalation via an aerosol. The Examiner established above (in relation to instant claim 67) that it would be obvious to administer nitrous oxide (NMDA receptor antagonist) via inhalation. The Examiner also established above that NMDA receptor antagonist (such as nitrous oxide) can be administered prior to, after or concurrently with psilocybin and that if the NMDA receptor antagonist is taken concurrently with psilocybin, this means that psilocybin and the NMDA receptor antagonist would have be administered concurrently either as separate pharmaceutical compositions or as a single pharmaceutical composition. It would be obvious to one skilled in the art to administer psilocybin (5-HT2A receptor agonist) and nitrous oxide (NMDA receptor antagonist) concurrently as a single pharmaceutical composition by inhalation via an aerosol with a reasonable expectation of success. Thus, Londesbrough in view of Nagele renders obvious instant claims 43, 48 and 49 (as to instant claim 49, as stated above, nitrous oxide is a gas and thus, it would naturally be in a gas phase of the aerosol as instantly recited).
With respect to instant claim 44, Londesbrough teaches (pg.21, lines 14-17) that psilocybin is water-soluble. An aerosol is defined as a suspension of fine solid particles or fine liquid droplets in air or another gas (such as nitrous oxide) (see the Wikipedia definition of “aerosol” at https://en.wikipedia.org/wiki/Aerosol ). Since it is much more convenient and cost-effective to dissolve psilocybin in water (so that when aerosolized, it forms fine liquid droplets) than to grind psilocybin crystals into fine powders (so that when aerosolized, it forms fine solid particles), it would be obvious to one skilled in the art to dissolve the psilocybin in water so as to form fine liquid droplets when aerosolized. The fine liquid droplets of psilocybin suspended in nitrous oxide is an aerosol in the form of a mist. Thus, Londesbrough in view of Nagele renders obvious instant claim 44.
With respect to instant claims 30-31, as discussed above, Londesbrough in view of Nagele teaches instant pharmaceutical composition formulated for administration via inhalation, comprising a 5-HT2A receptor agonist (psilocybin), nitrous oxide and water (instant pharmaceutically acceptable excipient – see pg.95, lines 24-27 of present specification). Thus, Londesbrough in view of Nagele renders obvious instant claims 30-31.
Claim(s) 73 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Nagele et al (“Exploring Nitrous Oxide as Treatment for Mood Disorders: Basic Concepts”, J Clin Psychopharmacol. Apr 2018, vol.38(2), pg.144-148) as applied to claim 67 above, and further in view of Gilligan et al (WO 2022/195489 A2).
As already discussed above (in relation to claim 67), Londesbrough teaches (pg.43, lines 19-20) that its psilocybin can be administered intravenously, but the reference does not teach instant limitations of claims 73 and 74. However, Gilligan teaches (see abstract, [0004] and [0005]) a method of treating a psychological disorder in a subject by administering to the subject a sufficient amount of a psychedelic (such as psilocybin) to induce a dissociative state in the subject less than 30 minutes after administration, and thereafter maintaining the mean plasma concentration of the psychedelic at a predetermined value in order to maintain the dissociative state during a therapeutic window. Gilligan further teaches ([0028]-[0029], [0031]) that the dissociative state is induced by intravenous administration of a loading dose of the psychedelic, which comprises administration of an initial bolus of the psychedelic (psilocybin) in the amount of about 0.02 mg/kg to about 0.2 mg/kg. Gilligan also teaches ([0036]-[0037] and [0043]) that the maintenance dose of the psychedelic is administered by intravenous infusion (instant perfusion of claims 73-74) at a rate of about 0.2 mg/min to about 1 mg/min over a period of about 30 – 120 minutes. As to instant range about 0.1 mg/kg to about 0.8 mg/kg (for the initial bolus), Gilligan’s range about 0.02 mg/kg to about 0.2 mg/kg overlaps with instant range, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). As to instant range about 0.1 mg/kg to about 0.8 mg/kg (for the perfusion), Gilligan’s intravenous infusion rate of about 0.2 mg/min to about 1 mg/min for a time period of about 30-120 minutes gives a total amount of infused psychedelic to range from about 6 mg to about 120 mg. Assuming that the subject weighs from 60 kg to 100 kg, this gives a range of from 0.06 mg/kg to 2 mg/kg. Such range overlaps with instant range about 0.1 mg/kg to about 0.8 mg/kg, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Londesbrough in view of Nagele, and further in view of Gilligan renders obvious instant claims 73 and 74.
Claim(s) 78 is rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Geddes (“Psychedelic drug DMT to be trialled in UK to treat depression”, a newspaper article from The Guardian published on Dec 9, 2020 (obtained from the website: https://www.theguardian.com/science/2020/dec/09/psychedelic-drug-dmt-to-be-trialled-in-uk-to-treat-depression ).
Londesbrough does not teaches instant 5-HT2A receptor agonist of claim 78 (N,N-dimethyltryptamine (DMT) or its acceptable salt or solvate thereof). As evidenced by Geddes (see the 1st paragraph), it has been known in the art that DMT can treat depression. Geddes further teaches (10th and 11th paragraphs) that the difference between DMT and psilocybin is that for DMT, the psychedelic experience comes faster and more intensely but is over more quickly. A psilocybin treatment session can last all day – which is a large time constraint – whereas DMT treatment session will probably take under 2 hours. DMT is a rapid-acting equivalent of psilocybin. Therefore, rapid-acting relief from depression can be obtained within hours of a session, and the effect will be sustained over a similar time period as psilocybin. Thus, it would be obvious to one skilled in the art to use DMT as Londesbrough’s 5-HT2A receptor agonist so as to achieve rapid-acting relief from depression within hours of a session while sustaining the effect over a similar time period as psilocybin. Thus, Londesbrough in view of Geddes renders obvious instant claim 78.
Claim(s) 80 is rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Geddes (“Psychedelic drug DMT to be trialled in UK to treat depression”, a newspaper article from The Guardian published on Dec 9, 2020 (obtained from the website: https://www.theguardian.com/science/2020/dec/09/psychedelic-drug-dmt-to-be-trialled-in-uk-to-treat-depression ) and Rands et al (WO 2020/245133 A1).
Londesbrough in view of Geddes does not teaches instant 5-HT2A receptor agonist of claim 80 (DMT-D10 or its acceptable salt or solvate thereof). Rands teaches (pg.1, last paragraph) that DMT has therapeutic value as a short=acting psychedelic, however its duration of action (under 20 minutes) is so short as to limit effective therapy. Administration protocols have been developed to extend the immersive psychedelic experience of DMT through intravenous infusion. However, these protocols carry risk of toxic buildup in patients who are poor metabolisers of DMT. Rands further teaches (pg.2, 1st paragraph) that deuterated forms of DMT, such as a,a,b,b-tetradeutero-N,N-dimethyltryptamine, exhibits a kinetic isotope effect, the half-life of the deuterated form of DMT is longer than half-life of the undeuterated form. This would allow a patient to be maintained in “DMT space” for longer than therapeutically essential. Rands further teaches (pg.18, 2nd paragraph) that increasing deuterium enrichment at the a-carbon (I.e., the carbon attached to the dimethylamino moiety) of N,N-dimethyltryptamine increases metabolic stability, leading to a decrease in clearance and longer half-life. A linear relationship also exists between molecular weight and half-life. Thus, it would be obvious to one skilled in the art to deuterate DMT so that it reaches the fully deuterated form of DMT (i.e., d10) in order to maximize the half-life of DMT so as to allow a patient to be maintained tin DMT space for longer than therapeutically essential. Thus, Londesbrough in view of Geddes and Rands render obvious instant claim 80.
Claim(s) 79 is rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Terwey (WO 2020/169851 A1).
Londesbrough does not teach instant 5-HT2A receptor agonist (5-MeO-DMT) or its acceptable salt or solvate). Terwey teaches (see pg.11, last paragraph and pg.12, 1st paragraph) the use of therapeutically effective amounts of 5-MeO-DMT in the treatment of mental disorders, such as major depressive disorder, obsessive-compulsive disorder and anxiety disorder. Terwey teaches (see pg.15, 1st paragraph) that as compared to the previously studied psychedelics, 5-MeO-DMT can provide (i) a similar or better clinical response with a shorter duration of the acute psychoactive effects after dosing and therefore improved convenience and compliance, (ii) an improved dosing regimen with higher propensity for and better reproducibility of achievement of peak psychedelic experiences while avoiding unnecessary high doses and associated side effects, and (iii) with better tolerability, and therefore improved compliance. Thus, it would be obvious to one skilled in the art to use 5-MeO-DMT as Londesbrough’s 5-HT2A receptor agonist with a reasonable expectation of achieving all the advantages listed above. Thus, Londesbrough in view of Terwey renders obvious instant claim 79.
Claim(s) 81 is rejected under 35 U.S.C. 103 as being unpatentable over Londesbrough et al (WO 2020/212951 A1) in view of Terwey (WO 2020/169851 A1) and Rands et al (WO 2020/245133 A1).
Londesbrough in view of Terwey renders obvious the use of 5-Me-O-DMT as Londesbrough’s 5-HT2A receptor agonist. Although the prior arts do not teach the use of the deuterated form of 5-Me-O-DMT, it is the Examiner’s position that by the same logic as discussed above in relation to the rejection of instant claim 80, under the teaching of Rands et al, it would be obvious to one skilled in the art to deuterate 5-Me-O-DMT so that it reaches the fully deuterated form of 5-Me-O-DMT (i.e., d10) in order to maximize the half-life of 5-Me-O-DMT so as to allow a patient to be maintained in 5-Me-O-DMT space for longer than therapeutically essential. Thus, Londesbrough in view of Terwey and Rands render obvious instant claim 81.
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 30, 32-40, 61, 65-67 and 78-81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 18, 22-25 and 36 of copending Application No. 18/852,115 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 12 of App.’115 teaches a method of treating a subject with CNS disorder or a psychiatric disease, the method comprising administering to the subject a therapeutic amount of NMDA receptor antagonist, which is nitrous oxide, and a therapeutic amount of 5-HT2A receptor agonist, which is a compound of instant Formula (I) or its salt, stereoisomer, solvate or prodrug thereof. Claim 18 of App.’115 teaches that the compound of Formula (I) can be
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(which teaches instant DMT-d10 of claim 80) or
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(which teaches instant 5-MeO-DMT-d10 of claim 81). Claims 22-25 of App.’115 teach that the CNS disorder or psychiatric diseas can be MDD, TRD, GAD, social anxiety disorder, OCD or alcohol use disorder. Claim 36 of App.’115 teaches that its 5-HT2A receptor agonist is administered intravenously and the NMDA receptor antagonist is administered via inhalation. Thus, claims 12, 18, 22-25 and 36 of App.’115 render obvious instant claims 30, 32-40, 61, 65-67 and 78-81: (i) as to instant claim 30, it is a common pratice in the art to include at least a carrier for a drug when administering the drug. Thus, it would be obvious to one skilled in the art to use a carrier (instant excipient of claim 30) for the NMDA receptor antagonist and 5-HT2A receptor antagonist with a reasonable expectation of success; (ii) as to instant calims 65 and 66, since claim 36 of App.’115 teaches that the 5-HT2A receptor agonist is administered intravenously and the NMDA receptor antagonist is administered via inhalation, this means that the 5-HT2A receptor agonist and the NMDA receptor antagonist would have to be administered either sequentially as separate compositions or concurrently as spearate compositions; (iii) as to instant claims 78 and 79, as discussed above, claim 18 of App.’115 teaches instatnt DMT-d10 (which is instant DMT of claim 78 in deuterated form) and instant 5-MeO-DMT-d10 (which is instatn 5-MeO-DMT of claim 79 in deuterated form).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 30-38, 40, 42-44, 48, 49, 61, 78 and 80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 25, 28, 29 and 31 of copending Application No. 18/027,810 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claims 24-25 of App.’810 teach a method of treating CNS disorder or psychological disorder in a patient, comprising administering to the patient, via inhalation, an aerosol (in the form of a mist) comprising a psychedelic drug compound of Formula (II) (that teaches instant compound of Formula (I)) in a carrier (instant excipient). Claims 29 and 31 of App.’810 teaches that the aerosol is prepared by nebulization of the psychedelic drug wherein the nebulization is performed using a driving gas comprising nitrous oxide (instant NMDA receptor antagonist). Claim 24 and 28 of App.’810 teach that the method can treat MDD, TRD, GAD, social anxiety disorder and OCD. Thus, claims 24, 25, 28, 29 and 31 of App.’810 render obvious instant claims 30-38, 40, 42-44, 48, 49, 61, 78 and 80 (as to instant 43, since claims 29 and 31 of App.’10 teaches that the aerosol is prepared by nebulization of the psychedelic drug wherein the nebulization is performed using nitrous oxide, it is the Examiner’s position that the drug and the nitrous oxide are being administered concurrently as a single pharmaceutical composition; as to instant claims 78 and 80, in the compound of Formula (II) shown in claim 1 of App.’810, it would be obvious to have all of X1, X2, Y1, Y2, R2, and R4-R7 either to be H atoms (which gives instant DMT of claim 78) or deuterium atoms (which gives instant DMT-d10 of claim 80) with a reasonable expectation of success).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
May 16, 2026
Prosecution Insights