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
This application is a continuation of PCT/US2023/022720.
The amendment filed on March 25, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on March 25, 2026 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 25, 2026.
Status of Claims
Claims 1-20 are pending.
Claims 12-20 are withdrawn.
Claims 1-11 are under examination.
Claim for Domestic Priority
Applicants' claim for domestic priority under 35 USC 119(e) to US provisional application 63/364,927, filed 05/18/2022, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 2, 2023, September 22, 2023, and March 13, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: A conjunction is missing between the steps “forming a mixture..” and “separating solids..”. Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solecki (WO 2021/159213 “Neonmind” - form PTO-1449) and Yoshihiro (JP 2011236183 “Unitika" and the English Translation of JP 201123618 – form PTO-1449).
Regarding claim 1, Solecki discloses a method comprising (A) forming a mixture comprising (i) a fungus comprising chitin and psilocybin or psilocin (page 4 line 15 through page 4, line 6, page 5, lines 11-21, page 6, lines 22-24, and page 8, lines 12-21), and (ii) an extraction solution (page 5, lines 12-15), and (B) separating solids from the mixture to yield an extract comprising the psilocybin and/or the psilocin (page 5, lines 11-21 and page 8, lines 12-21).
Regarding claim 2, Solecki discloses purifying the extract to isolate the psilocybin and/or the psilocin (solution is first contacted with aqueous solvent for fractionation (extract) and after filtering first solid fraction, solution is contacted with alcohol solvent for further isolation of compound, wherein resulting extract comprises psilocybin) (page 5, lines 13-19 and page 8, lines 12-21).
Regarding claim 3, Solecki discloses contacting the extract with a solvent that is immiscible with the extraction solution, wherein psilocybin and/or psilocin is more soluble in the solvent than in the extraction solution, and separating the solvent comprising the psilocybin and/or psilocin from the extract (solution is first contacted with aqueous solvent for fractionation (extract) and after filtering first solid, fraction, solution is contacted with alcohol solvent for further isolation of compound, wherein further filtering the fractions (separating the solvent) resulting extract comprises psilocybin)) (page 5, lines 13-19 and page 8, lines 12-21).
Regarding claim 4, Solecki discloses grinding the fungus prior to forming the mixture, such as cutting into pieces or grinding via a food processor (page 5, lines 13-19 and 21 and page 8, lines 4-7).
Regarding claim 5, Solecki discloses heating the mixture to a temperature of 100°C and maintaining the mixture at said temperature for at least 6 hours prior to the separating step (page 8, lines 23-26).
Regarding claim 8, Solecki discloses an extraction solution comprising of water (page 8, lines 9-10).
Solecki does not disclose forming a mixture comprising a chitinase capable of digesting the chitin. However, Solecki discloses that chitin, comprised in the cell wall of mushrooms, is a relatively tough material, which is typically degraded by chitinase (page 5, lines 4-6). Solecki discloses that chitin creates a challenge when manufacturing mushroom extracts at an industrial scale.
Regarding claim 1, Yoshihiro discloses a chitinase capable of digesting the chitin (extraction of fungus includes enzyme such as chitinase for extraction of compound (page 4, last paragraph).
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to further modify the method of Solecki by adding a chitinase into the mixture comprising a fungus comprising chitin and psilocybin/psilocin. One having ordinary skill in the art would have been motivated to do so in order to degrade chitin and increase extraction of psilocybin/psilocin. One having ordinary skill in the art would have has a reasonable expectation of success since Solecki discloses a method extracting psilocybin/psilocin from a fungus, Solecki discloses that chitinase digests chitin, a tough material of the fungus cell wall, and Yoshihiro discloses using chitinase for extraction of compounds from fungus.
Therefore, the above references render claims 1-5 and 8 prima facie obvious.
Claim(s) 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solecki (WO 2021/159213 “Neonmind” - form PTO-1449) and Yoshihiro (JP 2011236183 “Unitika" and the English Translation of JP 201123618 – form PTO-1449). as applied to claims 1-5 and 8 above, and further in view of Hateet (GC-MS Analysis of extract for Endophytic fungus Acremonium coenophialum and its Antimicrobial and Antidiabetic. Research Journal of Pharmacy and Technology. Vol. 13, No. 1, January 2020. – form PTO-1449).
Solecki and Yoshihiro do not disclose purifying the psilocybin and/or psilocin or using ethyl acetate and/or chromatography.
Regarding claim 6, Hateet discloses purifying fungal extracts by chromatography (purification of fungus was performed with column chromatography) (abstract and Section 2.4 at page 120).
Regarding claim 9, Hateet discloses using the solvent ethyl acetate (abstract and Section 2.2 at page 120).
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to purify the psilocybin and/or psilocin via chromatography and use ethyl acetate. One having ordinary skill in the art would have been motivated to do so in order to purify psilocybin/psilocin. One having ordinary skill in the art would have has a reasonable expectation of success since Solecki discloses a method extracting psilocybin/psilocin from a fungus, Solecki discloses that chitinase digests chitin, a tough material of the fungus cell wall, and Yoshihiro discloses using chitinase for extraction of compounds from fungus, and Hateet discloses purifying fugal extracts by chromatography and ethyl acetate.
Therefore, the above references render claims 1-6 and 8-9 prima facie obvious.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solecki (WO 2021/159213 “Neonmind” - form PTO-1449) and Yoshihiro (JP 2011236183 “Unitika" and the English Translation of JP 201123618 – form PTO-1449). as applied to claims 1-5 and 8 above, and further in view of Londesbrough (US 10,954,259 “Compass Pathfinder Limited” – form PTO-1449) and Shaba (Development of an improved psilocybin synthesis. Uppsala Universitet. June 2020 - form PTO-1449).
Solecki and Yoshihiro do not disclose using a phosphate salt to extract psilocybin.
Regarding claim 7, Londesbrough discloses adding a phosphate salt to the extract until psilocybin falls out of the mixture and separating the psilocybin from the mixture (large scale synthesis can use tetra benzyl pyrophosphate (phosphate salt) in intermediate step for obtaining psilocybin in higher quantities and purification by recrystallization and removal of impurity (adding a phosphate salt to the extract until psilocybin falls out of the mixture) before final drying in vacuum (separating psilocybin from mixture) (Column 23, lines 38-55 and Column 49, lines 29-36 and 52-57).
Shaba also discloses adding a phosphate salt to the extract until psilocybin falls out of the mixture and separating the psilocybin from the mixture (page 5, top paragraph and Scheme 2 and Section 3.4 at pages 10-13).
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to purify the psilocybin by adding a phosphate salt. One having ordinary skill in the art would have been motivated to do so in order to purify psilocybin. One having ordinary skill in the art would have has a reasonable expectation of success since Solecki discloses a method extracting psilocybin/psilocin from a fungus, Solecki discloses that chitinase digests chitin, a tough material of the fungus cell wall, and Yoshihiro discloses using chitinase for extraction of compounds from fungus, and Londesbrough and Shaba disclose purifying psilocybin with a phosphate salt.
Therefore, the above references render claims 1-5 and 7-8 prima facie obvious.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solecki (WO 2021/159213 “Neonmind” - form PTO-1449) and Yoshihiro (JP 2011236183 “Unitika" and the English Translation of JP 201123618 – form PTO-1449). as applied to claims 1-5 and 8 above, and further in view of Bergstrom (Enzymatic Pre-Treatment of Shiitake Mushroom. Lulea tekniska universitet. 2006. – form PTO-1449).
Solecki and Yoshihiro do not disclose the weight ratio of chitinase to the fungus in the mixture.
Regarding claim 10, Bergstrom discloses a weight ratio of the chitinase to the fungus in the mixture is from 0.1 to 2 (chitinase enzyme mixture is present in mixture at 200g to fungus 1000g, a 0.2 weight ratio (page 7, 3rd paragraph). It would have been well within the knowledge of one having ordinary skill in the art to vary and optimize the weights of chitinase to a fungus standard techniques and protocols. “[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.”, see MPEP 2144.
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to vary and optimize the ratio of chitinase to the fungus in the mixture using standard techniques and protocols. One having ordinary skill in the art would have been motivated to do so in order to optimize psilocybin and/or psilocin extraction and production. One having ordinary skill in the art would have has a reasonable expectation of success since Solecki discloses a method extracting psilocybin/psilocin from a fungus, Solecki discloses that chitinase digests chitin, a tough material of the fungus cell wall, and Yoshihiro discloses using chitinase for extraction of compounds from fungus, and Bergstrom discloses a weight ratio of the chitinase to the fungus in the mixture is from 0.1 to 2.
Therefore, the above references render claims 1-5, 8, and 10 prima facie obvious.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solecki (WO 2021/159213 “Neonmind” - form PTO-1449) and Yoshihiro (JP 2011236183 “Unitika" and the English Translation of JP 201123618 – form PTO-1449). as applied to claims 1-5 and 8 above, and further in view of Lightburn (US 11,331,357 – form PTO-1449).
Solecki and Yoshihiro do not disclose forming the mixture comprises agitating the fungus, the extraction solution, and the chitinase for 6 to 24 hours before the separating step.
Regarding claim 11, Lightburn discloses agitating the mixture comprising the fungus, the extraction solution, and the chitinase for 6 to 24 hours before the separating step (soaking step comprising extraction solution and fungus is performed with agitation up to 12 hours) (Column 74, lines 62-64 and Column 87, lines 1-14).
Therefore, in combining the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to agitate the mixture. One having ordinary skill in the art would have been motivated to do so in order to optimize psilocybin and/or psilocin extraction and production. One having ordinary skill in the art would have has a reasonable expectation of success since Solecki discloses a method extracting psilocybin/psilocin from a fungus, Solecki discloses that chitinase digests chitin, a tough material of the fungus cell wall, and Yoshihiro discloses using chitinase for extraction of compounds from fungus, and Lightburn discloses agitating a mixture comprising the fungus, the extraction solution, and the chitinase for 6 to 24 hours before the separating step.
Therefore, the above references render claims 1-5, 8, and 11 prima facie obvious.
Conclusion
Claims 1-20 are pending.
Claims 12-20 are withdrawn.
Claims 1-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652
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