DETAILED ACTION
Claims 1-27 are currently pending in the instant application. Claims 1-16 are rejected. Claim 13 is objected. Claims 17-27 are withdrawn from consideration as being for non-elected subject matter.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16, and the election of species of Polymorph A in the reply filed on 24 July 2026 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species does not appear allowable. Therefore, the search and examination has not been extended beyond the elected species.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 has multiple periods after the roman numerals in the claims. These periods should be deleted and could be replaced with “)” as seen with the letters, for example “a)”. Appropriate correction is required.
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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,505,564. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to a method for manufacturing crystalline Polymorph A of psilocybin from psilocin at a scale greater than 100g by:
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(conflicting claim 1). Conflicting claim 19 provides
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. Conflicting claim 21 provides wherein the heating with agitation is at a temperature from 75 degrees Celsius to 80 degrees Celsius. Conflicting claim 25 provides chemical purity of greater than 99%. Applicant’s instant claims are drawn to a process for preparing crystalline psilocybin (elected species of Polymorph A) by obtaining psilocybin and recrystallizing from water to provide the crystalline psilocybin where the temperature is less than 80 degrees Celsius (which is seen in conflicting claim 19). Instant claim 2 provides wherein the process produces about 100g or more (which is seen in conflicting claim 1). Instant claims 3 provides XRPD peaks (which are seen in conflicting claim 1). Instant claims 4, 5, and 8-10 provide the crystalline psilocybin with a chemical purity of greater than 97% and no single impurity of greater than 1%, such as psilocin or phosphoric acid impurity (which is seen in conflicting claim 25). Instant claim 6 provides heating to about 70 degrees Celsius and cooling to about 5 degrees Celsius for about 2 hours (which is seen in conflicting claim 19). Instant claim 7 provides wherein the psilocybin is obtained by the process as seen in conflicting claim 1 steps (i) and (ii). Instant claims 11-16 provide properties of crystalline psilocybin Polymorph A, which are necessarily present in the process of the conflicting claims as these properties are characteristicly inherent to the compound. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Additionally, see also In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable.").
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant’s instant claims are drawn to a process of preparing any crystalline psilocybin comprising obtaining psilocybin and recrystallizing the psilocybin from water to provide the crystalline psilocybin, wherein the temperature of the water is less than 80 degrees Celsius. However, the instant specification does not provide support for preparing any crystalline psilocybin form, but only provides support for preparing Form A or A’ . As seen in paragraph [00126]:
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and in this discussion of the seventh aspect of the present invention, paragraph [00129] provides:
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Form A is prepared. Additionally, paragraph [00202], paragraph [00210], and Stage 6, page 36, provide the process as claimed preparing high purity crystalline Polymorph A or A’ and no other forms of crystalline psilocybin. Example 1, paragraph [00246] provides the preparation of crystalline Polymorph A’. The preparation of polymorph Form A is found in paragraph [00250]-[00253]. Page 44 in paragraph [00275] that the additional crystallization step give rise to a defined crystalline form-Polymorph A (or A’). Paragraphs [00436] and [00437] provide different processes than the claimed process to prepare form Hydrate A and form Polymorph B
Conclusion
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.
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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.
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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 ____________________ 13 August 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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