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
The Amendments filed on 6/10/2026 has been received and entered.
Claims 17, 21-24, 27-28, 30, 33-34, 36, 39-40, 42, 51-52, 56, 59, 63, and 65-66 are pending and examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
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.
Response to Amendment
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, 21-24, 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), Yanagido et al. (2018, International Journal of Biological
Macromolecules, 117: 78–86) and CADTH (2019, Rapid Response Service, pages 1-14). This is a new rejection.
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, separate administration of the ingredients.
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).
CADTH teaches CBD is used separately from other drugs because of drug-drug interaction concerns (see page 9, paragraph 1).
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 etal. 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.
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 Cannabis sativa extract separately from other drugs because CADTH teaches CBD is used separately from other drugs because of drug-drug interaction concerns (see page 9, paragraph 1). 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 minimizing drug-drug interaction complications be administering CBD separately. 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.
Claim(s) 17, 21-22, 24, 27-28, 30, 33-34, 36, 39-40, 42, 51-52, 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), and CADTH (2019, Rapid Response Service, pages 1-14) 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). This is a new rejection.
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.
Response to Arguments
Applicant argues that there is no reason to combine all the ingredients together.
In response to Applicant’s argument, Psilocybe cubensis extract,
Cannabis sativa extract, Dipteryx odorata extract, Pyropia yezoensis extract, and Zingiber officinale extract are all taught by the references for treating inflammation. Therefore, a method of treating inflammation would be obvious for one to combine in treating inflammation.
Applicant argues that there is synergistic effect for anti-inflammatory treatment with the combination of ingredients.
In response to Applicant’s argument, for synergistic data to be convincing, Applicant needs to show amounts and ingredients with their controls and inflammation indices before and after treatment. All the ingredients are known for treating inflammation; therefore, there is nothing unpredictable. The amounts are not commensurate in scope with the claimed invention because Claim 17 has no amounts. Therefore, the data is not convincing.
Applicant argues that the amounts are not taught.
In response to Applicant’s argument, the ingredients are known for treating inflammation. One of ordinary skill in the art would know 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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