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
Claims 17, 21-22, 24, 27-28, 30, 33-34, 36, 39-40, 42, 51-52, 56, 59, 63, and 65-66 are pending and examined on the merits.
Election/Restrictions
Applicant’s election without traverse of the species ginger, long COVID, in the reply filed on Aug. 12, 2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/23/25, 10/26/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 40 is 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.
In Claim 40, the claim depends from Claim 17, which requires all the ingredients administered together in a therapeutic combination. The language of Claim 40 is administering anyone of the ingredients to be administered separately in a separate composition. Please clarify what is the combination or composition. Are all the ingredients required and administered together in one composition or are they individual compositions each to be administered separately?
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.
Claims 17, 21-22, 24, 27-28, 30, 33-34, 36, 39-40, 42, 51, 56, 59, 63, and 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over Nkadimeng et al. (2021, Journal of Inflammation Research, 14: 3729–3738), Kozela et al. (from IDS), Yu et al. (CN 106928181 A), and Yanagido et al. (2018, International Journal of Biological Macromolecules, 117: 78–86).
Nkadimeng et al. teaches a method of treating inflammation with anti-inflammatory effects of Psilocybe cubensis extracted in hot water (Abstract). The mushrooms are considered safe with lethal concentrations of 17 kg/70 kg in humans (page 3731, right column, paragraph 1). IC50 >250 microgram/mL (page 3733, Table 1). Psilocybe cubensis extracted in hot water would inherently contain psilocybin and psilocin. Humans with inflammation would be subject in need thereof. Water is a diluent. Thus, the limitation of Claim 56 is met. The treatment of inflammation would result in reduction in the severity of a symptom of the inflammatory condition. Thus, the limitation of Claim 63 is met. Long Covid involved inflammation thus the treatment of inflammation would result in treating long Covid inflammation. Thus, the limitation of Claim 65-66 are met.
However, Nkadimeng et al. does not teach Cannabis sativa extract, Dipteryx odorata extract, Pyropia yezoensis extract, and their concentrations.
Kozela et al. teaches a method of treating inflammation with THC and CBD from Cannabis extract (Abstract). THC and CBD are used at 1, 5, 10 microMolar (page 1619, Table A). Cannabis extract would include Cannabis sativa.
Yu et al. teaches a method of treating inflammation with tonka-bean derivative (Abstract). Tonka-bean derivative would include coumarin. Tonka-bean is also known as Dipteryx odorata.
Yanagido et al. teaches a method treating inflammation with porphyrans (Abstract) obtained from Pyropia yezoensis extracted in ethanol and water (page 79, left column, 2.2. Preparation of porphyrin from discolored nori).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use Psilocybe cubensis extract, Cannabis sativa extract, Dipteryx odorata extract, and Pyropia yezoensis extract because Nkadimeng et al. teaches a method of treating inflammation with anti-inflammatory effects of Psilocybe cubensis extracted in hot water (Abstract). Kozela et al. teaches a method of treating inflammation with THC and CBD from Cannabis extract (Abstract). Yu et al. teaches a method of treating inflammation with tonka-bean derivative (Abstract). Yanagido et al. teaches a method treating inflammation with porphyrans (Abstract) obtained from Pyropia yezoensis extracted in ethanol and water (page 79, left column, 2.2. Preparation of porphyrin from discolored nori). One would have been motivated to make a method of treating inflammation with Psilocybe cubensis extract, Cannabis sativa extract, Dipteryx odorata extract, and Pyropia yezoensis extract for the expected benefit of treating inflammation. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising psilocybin and psilocin in a weight ratio from about 1:5 to about 5:1, from about 50 microgram to about 500 microgram and from about 20 microgram to about 200 microgram of psilocin, THC and CBD in a weight ratio from about 1:5 to about 5:1, from about 0.1 mg to about 5 mg of THC and from about 0.1 mg to about 5 mg of CBD, from about 1 mg to about 10 mg of coumarin, from about 1 mg to about 20 mg of Pyropia yezoensis extract, about 10 mg and about 200 mg of the single composition per single dose of the active agent combination for the following reasons. The references do teach the composition for treating inflammation. Nkadimeng et al. teaches a method of treating inflammation with anti-inflammatory effects of Psilocybe cubensis extracted in hot water (Abstract). The mushrooms are considered safe with lethal concentrations of 17 kg/70 kg in humans (page 3731, right column, paragraph 1). IC50 >250 microgram/mL (page 3733, Table 1). Kozela et al. teaches a method of treating inflammation with THC and CBD from Cannabis extract (Abstract). THC and CBD are used at 1, 5, 10 microMolar (page 1619, Table A). Yu et al. teaches a method of treating inflammation with tonka-bean derivative (Abstract). Yanagido et al. teaches a method treating inflammation with porphyrans (Abstract) obtained from Pyropia yezoensis extracted in ethanol and water (page 79, left column, 2.2. Preparation of porphyrin from discolored nori). Thus, it would have been obvious to make a concentrated composition containing Psilocybe cubensis extract, Cannabis sativa extract, Dipteryx odorata extract, and Pyropia yezoensis extract for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claim(s) 17, 21-22, 24, 27-28, 30, 33-34, 36, 39-40, 42, 51-52, 56, 59, 63, and 65-66are rejected under 35 U.S.C. 103 as being unpatentable over Nkadimeng et al. (2021, Journal of Inflammation Research, 14: 3729–3738), Kozela et al. (from IDS), Yu et al. (CN 106928181 A), and Yanagido et al. (2018, International Journal of Biological Macromolecules, 117: 78–86) as applied to claims 17, 21-22, 24, 27-28, 30, 33-34, 36, 39-40, 42, 51, 56, 59, 63, and 65-66 above, and further in view of Wu et al. (FR 2811573 A1).
Wu et al. teaches a method of treating inflammation with Zingiber officinale extract (Claim 1). Zingiber officinale is also known as ginger.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use Psilocybe cubensis extract, Cannabis sativa extract, Dipteryx odorata extract, and Pyropia yezoensis extract because Nkadimeng et al. teaches a method of treating inflammation with anti-inflammatory effects of Psilocybe cubensis extracted in hot water (Abstract). Kozela et al. teaches a method of treating inflammation with THC and CBD from Cannabis extract (Abstract). Yu et al. teaches a method of treating inflammation with tonka-bean derivative (Abstract). Yanagido et al. teaches a method treating inflammation with porphyrans (Abstract) obtained from Pyropia yezoensis extracted in ethanol and water (page 79, left column, 2.2. Preparation of porphyrin from discolored nori). Wu et al. teaches a method of treating inflammation with Zingiber officinale extract (Claim 1).
One would have been motivated to make a method of treating inflammation with Psilocybe cubensis extract, Cannabis sativa extract, Dipteryx odorata extract, Pyropia yezoensis extract, and ginger extract for the expected benefit of treating inflammation. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655