DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed November 3, 2025 has been received and entered.
3. Claims 1-5, 7-10, 15, 20, and 35-43 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Group I, claims 1-5, 7-10, 15, and 37-43, and both refluxing and distilling for the species in the reply filed on November 3, 2025 is acknowledged.
5. Claims 20, 35, and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
6. Claims 1-5, 7-10, 15, and 37-43 are examined on the merits.
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.
7. Claim(s) 1-5, 7-10, 37, and 40-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin (US 8,784,835) in view of Chadeayne (WO 2022/132691 – priority date 12/16/2020).
Austin teaches a method for obtaining an Amanita muscaria extract having a reduced ibotenic acid content and an increased muscimol content. The reference teaches that the method comprises selecting biomass from A. muscaria, drying the biomass to a powder with a moisture content of 0.3 to 5%, performing aqueous extraction on the biomass at a temperature of 175-200°F (79 to 93°C) for at least an hour, reducing the pH of the extract to a pH of 2.6 or lower, refluxing, and obtaining the extract with the reduced ibotenic acid content and increased muscimol content where the ratio of muscimol to ibotenic acid can be at least 75 to 1 (see column 2, lines 16-34, Example 2, and claims 10 and 12). The reference does not explicitly state that the biomass is analyzed prior to the extraction. However, since the reference discusses the content of the muscimol and ibotenic acid both before and after the extraction, an artisan would appreciate that analysis of the biomass would need to be performed to obtain this data. The reference also does not teach that distillation is used to obtain the extract.
However, Chadeayne teaches using distillation to obtain extracts from A. muscaria that contain decreased ibotenic acid content and an increased muscimol content. In addition, the reference teaches that the A. muscaria extracts can be optimized to remove components such as stizolobinic acid and heavy metals including cadmium, arsenic, lead, and mercury (see paragraphs 27, 44, 49-50 and 65). Thus, an artisan of ordinary skill would have reasonably expected that distillation could be used with success to obtain the extract taught by Austin and remove any undesirable components such as heavy metals and stizolobinic acid. This reasonable expectation of success would have motivated the artisan to modify Austin to include the use of distillation to obtain the extract.
The references do not specifically teach using all of the extraction and distillation parameters claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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).” Varying the specific extraction and distillation parameters are not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed parameters produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
8. Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin (US 8,784,835) in view of Chadeayne (WO 2022/132691 – priority date 12/16/2020) as applied to claims 1-5, 7-10, 37, and 40-43 above, and further in view of Falandysz (Fungal Biology (2020), vol. 124, pp. 174-182).
The teachings of Austin and Chadeayne are discussed above. The references teach that heavy metals including cadmium, arsenic, lead, and mercury can be removed from the extract. However, the references do not teach the removal of arsenic. Falandysz teaches that arsenic is present in A. muscaria (see abstract). Thus, the artisan of ordinary skill would reasonably expect that the extract of Austin and Chadeayne should be modified to remove any arsenic present in the extract. This reasonable expectation of success would have motivated the artisan to modify the references to include removal of arsenic from the extract.
9. Claim(s) 38 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin (US 8,784,835) in view of Chadeayne (WO 2022/132691 – priority date 12/16/2020) as applied to claims 1-5, 7-10, 37, and 40-43 above, and further in view of Chilton (Lloydia (1976), vol. 39, no. 2-3, pp. 150-157 – abstract).
The teachings of Austin and Chadeayne are discussed above. The references do not specifically teach testing for the presence of Amanita pantherina in the biomass or that this testing to done by determining the concentration of stizolobinic acid in the extract. However, Chilton teaches that stizolobinic acid was present in all samples of A. pantherina and only one sample of A. muscaria. Thus, an artisan of ordinary skill would reasonably expect that stizolobinic acid could be used as a biomarker to determine if an A. muscaria sample is contaminated with A. pantherina. This reasonable expectation of success would have motivated the artisan to modify Austin and Chadeayne to include testing for A. pantherina using stizolobinic acid as a biomarker. This reasonable expectation of success would have motivated the artisan to modify the references to include this step of testing for A. pantherina using stizolobinic acid as a biomarker.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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