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 .
Election/Restrictions
Claims 1-20 are pending. Applicant's election with traverse of Group I, Claims 1-8 in the reply filed on 29 August 2025 is acknowledged. The traversal is on the ground that the claims are linked by a common inventive concept, thus there is no serious search burden. This is not found persuasive because the inventions lack the same or corresponding special technical feature. Even though the inventions of the groups require the technical feature of psilocybin, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Krotzer (US 2001/0008641 A1). Krotzer teaches compositions that can comprise psilocybin (Claim 24, page 13), and thus the technical feature of psilocybin was known in the art prior to the effective filing date of the instant application. The shared technical feature is therefore not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 29 August 2025.
Claims 1-8 are being examined on the merits.
Claim Status
Please note for clarity of the record that Claims 21-24 of the original claim set are being treated as canceled claims. However, in response to this Office Action, applicant is required to submit a complete claim set indicating Claims 21-24 having such canceled status, and any new claims should be numbered starting with Claim 25 (see 37 CFR 1.121(c)).
Information Disclosure Statement
The information disclosure statements filed 8 July 2023 as third party submissions fail to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because foreign and non-patent literature documents were not provided in the file wrapper. It has been placed in the application file, but the information referred to therein has not been considered as to the merits where lined through. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim 3 is objected to because L-arginine is listed twice. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teles et al. (US 2015/0366815 A1).
The instant claims are as of record, drawn to a composition comprising a psychoactive compound selected from psilocybin, psilocin, and combinations thereof and a supplement selected from an amino acid, Vitamin B6, piracetam, GABA, theobromine, caffeine, resveratrol, and combinations thereof.
Teles et al., however, anticipates the claims by teaching enteric soft capsules (composition) comprising psilocybine or psilocine ([0123], page 15, col 2; as required for instant Claim 1) as an active drug substance (psychoactive compound) which may be present in an amount from 5-80% of the matrix fill mass (total weight of the composition; [0142], page 16, col. 2; as required for instant Claim 2). The composition may additionally include:
the amino acids 5-hydroxytryptophan, tryptophan (L-tryptophan; [0102], page 12, col. 1), and arginine (L-arginine; [0080], page 8, col. 1; as required for instant Claims 1, 3, and 7);
vitamins B1 (thiamine), B6, C, choline, and niacin ([0105], page 12, col. 2; as required for instant Claims 1, 4, 7, and 8);
piracetam ([0118], page 14, col. 1; as required for instant Claims 1 and 7);
caffeine ([0102], page 12, col. 1; as required for instant Claims 1 and 7);
resveratrol ([0102], page 12, col. 1; as required for instant Claims 1 and 7);
creatine ([0102], page 12, col. 1; as required for instant Claims 4 and 8);
glutathione ([0102], page 12, col. 1; as required for instant Claims 4 and 8); and
ginseng (plant herb; [0102], page 12, col. 1; as required for instant Claims 5 and 6).
Accordingly, the claimed invention as a whole was anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krotzer (US 2001/0008641 A1).
The instant claims are as of record, drawn to a composition comprising a psychoactive compound selected from psilocybin, psilocin, and combinations thereof and a supplement selected from an amino acid, Vitamin B6, piracetam, GABA, theobromine, caffeine, resveratrol, and combinations thereof.
Krotzer, however, anticipates the claims by teaching nutritionally beneficial compositions (supplement) comprising psilocybin as a substance that provides long term psychological feedback (psychoactive compound; Krotzer, Claim 24, page 13; as required for instant Claim 1) in addition to the amino acids L-glutamine, tryptophan, 5-hydroxytryptophan, L-tyrosine, and DL-phenylalanine, caffeine, theobromine, and/or GABA (Krotzer, Claims 1 and 4, page 12; as required for instant Claim 1), and Vitamin B6 (Krotzer, [0053], page 9; as required for instant Claim 1).
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Krotzer (US 2001/0008641 A1).
The instant claims are as of record, drawn to a composition comprising a psychoactive compound selected from psilocybin, psilocin, and combinations thereof and a supplement selected from an amino acid, Vitamin B6, piracetam, GABA, theobromine, caffeine, resveratrol, and combinations thereof.
Krotzer teaches nutritionally beneficial compositions (supplement) comprising psilocybin as a substance that provides long term psychological feedback (psychoactive compound; Krotzer, Claim 24, page 13; as required for instant Claim 1) in addition to:
the amino acids L-glutamine, tryptophan, 5-hydroxytryptophan, L-tyrosine, and DL-phenylalanine (Krotzer, Claims 1 and 4, page 12; as required for instant Claims 1, 3 and 7);
caffeine, theobromine, creatine monohydrate, GABA (Krotzer, Claims 1 and 4, page 12; as required for instant Claims 1, 3, 4, and 7);
Vitamin B6 (Krotzer, [0053], page 9; as required for instant Claims 1 and 8); and
the plant herbs ephedra, ginseng, and guarana (Krotzer, Claims 1 and 4, page 12; as required for instant Claims 5 and 6).
While Krotzer does not explicitly teach the specific amount of psychoactive compound of instant Claim 2, Krotzer does teach that the substituent that provides long term psychological feedback is present in an amount sufficient to provide a long term feeling of well-being or calmness (Krotzer, Claim 4, page 13). Based upon this overall beneficial teaching, the adjustments of particular conventional working conditions (e.g., determining one or more suitable range of psilocybin to provide in the composition) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. A skilled artisan would be motivated to modify the amount of psilocybin to obtain the desired effect of well-being or calmness as taught by Krotzer.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 10:00pm EST.
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, Terry McKelvey can be reached at (571)272-0775. 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.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655