DETAILED ACTION
Claims 1-29 are currently pending in the instant application. Claims 1-7, and 27-29 are rejected. Claims 8-26 are objected.
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 .
Terminal Disclaimer
The terminal disclaimer filed on 23 July 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on pending reference Application Numbers:
18/433,051
19/296,350
19/296,543
and the expiration date of the full statutory term of prior patent numbers:
10,519,175
10,947,257
10,954,259
11,180,517
11,629,159
11,851,451
11,939,346
12,312,375 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 24 July 2026 have been fully considered and entered into the instant application.
Applicant’s amendment to claims 2-5 has overcome the 35 USC 112(b) rejection as being indefinite. While claims 27-29 have been amended to add “of crystalline forms of psilocybin” after “the mixture”, claims 27-29 are still considered indefinite as it is unclear what “crystalline psilocybin” has a specific chemical purity. It is unclear if “the crystalline psilocybin” refers to “the mixture of crystalline forms of psilocybin” or to one of the specific crystalline psilocybin in the mixture. It is unclear if it is one of the specific crystalline psilocybin in the mixture, which one it is. The 35 USC 112(b) rejection of claims 27-29 is therefore maintained.
Applicant’s amendment to claim 7 has overcome the 35 USC 112(d) rejection of claim 7.
In regards to the non-provisional rejections over patents with a later patent term filing date, 11,564,935; 12,377,112; 12,433,904; 11,738,035; 11,865,126; 12,447,164; and 12,611,418 and the provisional rejections over applications with a later patent term filing date, 18/703,950; 18/718,103; 19/234,582; and 19/423,663 Applicant argues that these patents and applications are improper references for non-statutory double patenting citing the Federal Circuit decision Allergan and Ex parte Baurin:
PNG
media_image1.png
48
624
media_image1.png
Greyscale
This argument is not persuasive as the office follows practice as discussed in MPEP 804. Current Office guidance instructs examiners to consider two rationales when making OTDP rejections. See MPEP § 804(II)(B). As spelled out in that guidance, "[a] rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent." Moreover, the guidance states, "[a] double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention.". In the instant application, the holding of Allergan does not apply to the facts here as the claims under examination are not the first filed, first-issued, and later-expiring. Specifically, at least for the fact that the instant application is still pending and the claims are therefore not “first issued”. It will rarely, if ever, arise in original examination, that the claims under examination are first-filed, first-issued, and later-expiring, because a patent examiner will rarely, if ever, be in the position to determine that the claims under examination will be first-filed, first-issued, and later-expiring. Additionally, patent term is only one aspect of terminal disclaimers where the other major aspect is to avoid the potential for harassment of an accused infringer by multiple parties with patents covering the same patentable invention. Terminal disclaimers are filed for the purpose of preventing the prolongation of monopoly for patentably indistinct inventions and to enforce the covenant against dual ownership. See 37 CFR 1.321(c)(3). The doctrine of nonstatutory double patenting also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). The submission of a terminal disclaimer in compliance with 37 CFR 1.321(c) or (d) to overcome a double patenting rejection ensures that a patent owner with multiple patents claiming obvious variations of one invention retains all those patents or sells them as a group. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767. See MPEP 804.
Lastly, In regards to the arguments citing Ex Parte Baurin, the examiner is unaware of any official guidance regarding the cited decision in Ex Parte Baurin. Accordingly, while said decision is carefully considered and compared to the fact pattern of the instant case, it is not considered as binding precedent.
In regards to the provisional rejections over applications with a later patent term filing date, 18/703,950; 18/718,103; 19/234,582; and 19/423,663, Applicant additionally argues that if a provisional nonstatutory double patenting rejection is the sole remaining rejection in the present application, the rejection should be withdrawn and the present application be allowed to issue as a patent. As the provisional nonstatutory double patenting rejections over 18/703,950; 18/718,103; 19/234,582; and 19/423,663 are not the sole remaining rejections, the rejections are considered proper and maintained.
As there are pending rejections, the objection to claims 8-26 is maintained.
The following provisional rejections over applications 19/661,190; 19/661,115; 19/629,952; and 19/569,250 are new rejections as the cases are new cases which were docketed after the examiner prepared the previous non-final rejection.
Claim Objections
Claims 8-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,447,164. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating an eating disorder by administering crystalline psilocybin characterized by XRPD peaks at 11.5, 12.0, 14.5, 17.5 and 19.7 +/- 0.1 which has a chemical purity of greater than 97% as determined by HPLC analysis, see for example, conflicting claims 1 and 17. Conflicting claims 15 and 32 provide an additional peak of 20.4, 22.2, 24.3 or 25.7. Conflicting claims 16 and 33 provide no greater than 1% of a single impurity. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘164 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12,433,904. Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claims are drawn to methods of treating a migraine by administering crystalline psilocybin characterized by XRPD peaks at 11.5, 12.0, 14.5, 17.5 and 19.7 +/- 0.1 which has a chemical purity of greater than 97% as determined by HPLC analysis, see for example, conflicting claims 1 and 17. Conflicting claims 13 and 28 provides additional XRPD peaks. Conflicting claims 74 and 29 provides having no single impurity of greater than 1%. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixture. The method claims of the ‘904 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No.12,377,112. Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claims are drawn to methods of treating ADHD and ASD by administering crystalline psilocybin characterized by XRPD peaks at 11.5, 12.0, 14.5, 17.5 and 19.7 +/- 0.1 which has a chemical purity of greater than 97% as determined by HPLC analysis, see for example, conflicting claim 1 and 6. Conflicting claims 12 and 20 provides no single impurity of greater than 1% . Conflicting claims 19 and 27 provides additional peaks. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7). The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘112 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,865,126. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating anxiety disorder by administering crystalline psilocybin characterized by XRPD peaks at 11.5, 12.0, 14.5, 17.5 and 19.7 +/- 0.1 which has a chemical purity of greater than 97% as determined by HPLC analysis, see for example, conflicting claims 1 and 14. Conflicting claims 10 and 24 provide an additional peak of 20.4, 22.2, 24.3 or 25.7. Conflicting claims 11 and 25 provide no greater than 1% of a single impurity. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘126 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,738,035. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating anorexia by administering crystalline psilocybin characterized by XRPD peaks at 11.5, 12.0, 14.5, 17.5 and 19.7 +/- 0.1 which has a chemical purity of greater than 97% as determined by HPLC analysis, see for example, conflicting claims 1 and 13. Conflicting claims 10 and 23 provide an additional peak of 20.4, 22.2, 24.3 or 25.7. Conflicting claims 11 and 24 provide no greater than 1% of a single impurity. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘035 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,564,935. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating post traumatic stress disorder by administering crystalline Polymorph A psilocybin characterized by XRPD peaks at 11.5, 12.0, 14.5, 17.5 and 19.7 +/- 0.1 which has a chemical purity of greater than 97% as determined by HPLC analysis, see for example, conflicting claim 1 and 14. Conflicting claims 10 and 24 provide an additional peak of 20.4, 22.2, 24.3 or 25.7. Conflicting claims 11 and 25 provide no greater than 1% of a single impurity. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline Polymorph A of psilocybin having a chemical purity of greater than 97% and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘935 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,611,418. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating a bipolar disorder with psilocybin with XRPD peaks at 11.5, 12.0, 14.5, 17.5, and 19.7. Conflicting claim 16 provides additional XRPD peaks. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘418 patent read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 of copending Application No. 19/234,582 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating a neurocognitive disorder with psilocybin with XRPD peaks at 11.5, 12.0, 14.5, 17.5, and 19.7. Conflicting claim 8 provides no single impurity of greater than 1%. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and no single impurity of greater than 1% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘582 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22, 25-27, 29, 34-37, 46 and 47 of copending Application No. 18/718,103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating treatment resistant depression with psilocybin. Conflicting claim 46 and 47 provides crystalline psilocybin with specific XRPD peaks including 17.5 and 19.7. Conflicting claim 45 provides chemical purity of greater than 97%. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7. The method claims of the ‘103 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 17-18, 23-26, 50, 51, 54 and 55 of copending Application No. 18/703,950 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating treatment resistant depression with psilocybin. Conflicting claim 23 provides crystalline psilocybin with specific XRPD peaks including 17.5 and 19.7. Conflicting claim 24 provides chemical purity of greater than 97%. Conflicting claim 25 provides no single impurity greater than 2%. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% and no single impurity of greater than 2% which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘950 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-162 of copending Application No.19/423,663 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating depression (conflicting claim 1) with crystalline psilocybin which comprises at least 95% by weight of Polymorph A (conflicting claim 35), or a formulation (conflicting claim 108), crystalline psilocybin (conflicting claim 109), methods of treating other diseases with crystalline psilocybin which comprises highly pure polymorph A (conflicting claim 130), with chemical purity of greater than 97% and no single impurity of greater than 1% (conflicting claim 132). The conflicting specification provides polymorph A XRPD peaks on page 23 in Table A-XRPD peak positions for polymorph A. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to products of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% which reads on the instantly claimed crystalline psilocybin mixtures. The product and methods of claims of the ‘663 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of copending Application No. 19/661,190 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to crystalline psilocybin with peaks at 17.5 and 19.7 (conflicting claim 1) with additional peaks in conflicting claims 2 and 3. Conflicting claims 4-8 provide chemical purity up to 99%. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to products of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7, having a chemical purity of greater than 97% which reads on the instantly claimed crystalline psilocybin mixtures. The product of the claims of the ‘190 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/661,115 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treatment of treatment resistant depression with crystalline psilocybin with peaks at 17.5 and 19.7 (conflicting claims 9 and 10 and pharmaceutical compositions of crystalline psilocybin with peaks at 17.5 and 19.7. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and pharmaceutical compositions which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘115 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 of copending Application No. 19/629,952 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to processes of preparing products of crystalline psilocybin with peaks at 17.5 and 19.7 (conflicting claim 3) with additional peaks in conflicting claim 14. Chemical purity wherein the crystalline psilocybin as a chemical puritye of greater than 97% is found in conflicting claim 4 with no single impurity of greater than 1% in conflicting claim 5. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to processes of preparing crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 and pharmaceutical compositions which reads on the instantly claimed crystalline psilocybin mixtures. The process claims of the ‘952 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/569.250 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to methods of treating a substance disorder with crystalline psilocybin with peaks at 17.5 and 19.7 (conflicting claims 1 and 20) with a chemical purity of greater than 97%. Conflicting claims 18 and 29 provide additional peaks. Applicant’s instant claims are drawn to a mixture of crystalline forms of psilocybin wherein the mixture comprises x-ray diffraction peaks at 17.5 and 19.7 (instant claim 1), 11.5 and 12.0 (instant claim 2), 11.5 and 14.5 (instant claim 3), 12.0 and 14.5 (instant claim 4), peaks at 20.4, 22.2, 24.3, and 25.7 (instant claim 5), peaks at 14.5 and 19.6 +/- 0.1 (instant claim 6) and at least one peak at 11.5, 12.0, 19.4 and 24.3 (instant claim 7) . The conflicting claims are drawn to methods of use of crystalline psilocybin with specific XRPD peaks, including 17.5 and 19.7 which reads on the instantly claimed crystalline psilocybin mixtures. The method claims of the ‘250 application read on Applicant’s instant product claims which are mixtures of crystalline psilocybin having the claimed XRPD peaks as the instant claims are drawn to mixtures comprising crystalline polymorph A as seen by the claimed XRPD peaks with +/- 0.1 and the purity of the conflicting claims allows for a mixture.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, claim 1 is drawn to a mixture of crystalline forms of psilocybin. Claims 27-29 are drawn to “the mixture of crystalline forms of psilocybin of claim 1” wherein “the crystalline psilocybin has a chemical purity of…”.
When referencing “the crystalline psilocybin” it is unclear of the reference is to a purity of “the mixture of crystalline forms of psilocybin of claim 1” as a whole, or, if not intended to reference “a mixture of crystalline forms of psilocybin”, it is unclear if 27-29 are referring to one specific “crystalline psilocybin” in the mixture, and if so, which one. For example, if claims 27-29 are referring to the chemical purity of a specific crystalline psilocybin in the mixture, it is unclear which one is being referred to, for example, form A, form A’, form B, etc.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format.
For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 11 August 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
Prosecution Insights