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 .
Detailed Action
Response to Amendments
The amendments made to the claims 07/29/2026 have been entered.
Restriction/Species Election
Claims 1, 3, and 19 are considered allowable. Claims 4-14, 16-18, and 20 are hereby rejoined.
Information Disclosure Statements
The information disclosure statement (IDS) submitted 07/30/2026 has been considered.
New Rejections
Claim Rejections - 35 USC § 103
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 17-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sherwood (Synthesis, 2020, 52, 688-694) in view of Yu (Advanced Drug Delivery Reviews 48, 2001, 27-42) and Llng (CNS Drugs, 2022, 36:17-30).
Claim 17 is drawn to “A method for producing an amorphous composition comprising psilocybin, the method comprising (a) synthesizing a psilocybin component; and (b) producing an amorphous composition comprising the psilocybin component.”
Sherwood is drawn to and teaches a method of synthesizing psilocybin (p. 691, Scheme 5). Yu in its abstract states “The importance of amorphous pharmaceutical solids lie in their useful properties, common occurrence, and physio-chemical instability relative to corresponding crystals.”
Regarding claim 18, Yu continues “Amorphous solids can be produced by common pharmaceutical processes, including melt quenching, freeze- and spray-drying, milling, wet granulation, and drying of solvated crystals.” Yu on p. 31, sec. 3.1.1 states “Grinding or milling of crystals can remove all traces of crystallinity according to XRD.”
Sherwood provides a method of synthesizing a psilocybin component. Yu teaches methods of creating an amorphous form and also provides motivation.
Regarding claim 20, Llng in Table 2 teaches studies showing that psilocybin has efficacy as medication for major depressive disorder (MDD). Llng in sec. 4 states “In consideration of the molecular mechanisms presented herein, administration of psilocybin may be a potentially efficacious treatment for MDD and TRD. The mechanisms discussed may underlie diverse physiological and behavioral outcomes of psilocybin exhibited in human molecular studies comprising health subjects and/or patients with MDD.”
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have combined the teachings of Sherwood, Yu, and Llng to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill in the art would find motivation to combine the references as Yu teaches advantages of amorphous forms over crystalline forms and because Llng teaches psilocybin’s efficacy as treatment for MDD.
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.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 19/706,946 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 20 is drawn to “A method of treating a mental, behavioral, or neuropsychiatric condition and/or symptoms thereof in a subject, said method comprising administering a composition comprising amorphous psilocybin to the subject.
Reference claim 19 states “A method of improving motivation or cognitive engagement in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising: (a)….psilocybin…and (b) a pharmaceutically acceptable excipient.” The instant specification in para. [0178] states “In some embodiments, the cognitive condition is a cognitive…impairment.” Improving cognitive engagement would therefore embrace the instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Comments
The instant application is a divisional application of co-pending application 18/764,635 (parent application). The instant application was filed after a restriction requirement/species election made in the parent application.
Additional references to support conversion of a crystalline form to an amorphous form are found in Hancock (Pharm. Res. 17(4), 397, 2000) and Sharma (US20070129385).
Allowable Subject Matter
Claims 1, 3-14, 16, and 19 are considered allowable over the art. The closest art found in Sherwood requires crystallization to purify the compound which is avoided by the instant claims.
Conclusion
Allowable subject matter indicated.
Claims 17-18 and 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
