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. Claims 1-16 are currently pending.
Election/Restrictions
3. Applicant’s election without traverse of Group III, claims 11 and 12, in the reply filed on December 17, 2025 is acknowledged.
4. Claims 1-10 and 13-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
5. Claims 11 and 12 are examined on the merits.
Information Disclosure Statement
In the Information Disclosure Statement filed May 15, 2024, applicant did not provide copies of NPL references 4-8. Thus, these references could not be considered and the citations have been lined through.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
6. Claims 11 and 12 rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite a composition comprising a purified component from Amanita muscaria which is substantially free of ibotenic acid. Claim 12 specifies that the purified compounds is muscimol. A. muscaria is a naturally occurring mushroom and its component muscimol is a naturally occurring compound. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, the claims read directly on natural compounds from A. muscaria and, more specifically, muscimol. There can be no markedly distinct characteristic between the claimed product and the closest naturally occurring counterpart because they are one and the same. Thus, the claims read directly on a product of nature. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, there are no elements in addition to the natural compound. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, there are no elements in addition to the natural compound. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection, rather than an enablement rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, first paragraph, "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Claim 11 is drawn to a purified compound from Amanita muscaria which is substantially free of ibotenic acid. However, the specification only discloses muscimol, muscazone, stizolobic acid, stizolobinic acid, muscarine, muscarufin, muscaflavin, betalamic acid, muscapurpurin, muscaaurins, acetylcholine, atropine, hyoscyamine, L-3,4-dihydroxyphenylalanine, phallolysin, scopolamine, fucomannogalactan, ß(1->6)-branched (1-3)-B-d-glucan, amatoxins, phallotoxins, or the salts as the purified compounds. In analyzing whether the written description requirement is met for genus claims, it is first determine whether a representative number of species have been sufficiently described. In this case, only 20 compounds have been described while there are numerous other compounds that can potentially be isolated from A. muscaria. Applicant has only demonstrated possession of a small number of these potential compounds. This limited information is not deemed sufficient to reasonably convey to one skill in the art that applicant was in possession of all compounds purified from A. muscaria at the time the application was filed. As discussed in MPEP section 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species… A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)…
Since there are at numerous compounds that can be found in A. muscaria, there would be considerable variation within this genus. The description of only 20 species within this large genus is not considered to adequately describe the entire genus. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
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.
6. Claims 11 and 12 are 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.
The term “substantially free” in claim 11 is a relative term which renders the claim indefinite. The term “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not provide a closed, limiting definition for what concentrations of ibotenic acid are encompassed by “substantially free”. The specification states that less than 10% of ibotenic acid can be considered “substantially free.” However, the specification states that this is only one embodiment (see paragraph 52). Thus, it is unclear what amounts of ibotenic acid can be in the composition and the composition still be considered “substantially free”. Therefore, the metes and bounds of the claim are unclear.
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.
7. Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Austin (US 2014/0004084).
This reference teaches extracting muscimol from A. muscaria using a procedure which maximizes the concentration of muscimol and minimizes the concentration of ibotenic acid (see paragraphs 2 and 4). The reference teaches a embodiment where the ratio of muscimol to ibotenic acid is 90 to 1. The reference teaches that this composition can be further purified (see paragraphs 21 and 22).
Applicant’s specification defines “purified compound” as a compound which has a higher purity than found in nature (see paragraph 65) and gives an example of less than 10% ibotenic acid as “substantially free” (see paragraph 52). Thus, the composition of Austin is considered to meet the limitations of a “purified compound” which is “substantially free” of ibotenic acid because the concentration of muscimol and ibotenic acid fall within the defined parameters.
8. Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Muscimol” (https://www.sigmaaldrich.com/US/en/product/sial/phl89495?srsltid=AfmBOoosLvX2Xmgn8oklith0sW5wghLFEkfxapA50RhuWQFN1XSVc2Ra – accessed 1/15/2026) with Schwarz (PhytoLab data analysis of muscimol batch 62592761 (https://www.sigmaaldrich.com/certificates/Graphics/COfAInfo/fluka/pdf/PDF658370.pdf) dated 2018) providing evidence.
The “Muscimol” reference indicates that muscimol with over 98% purity was commercially available at least as early as 2018 as batch 62592761 (see documentation of by Schwarz). The reference does not state that the muscimol is an A. muscaria compound. However, a chemical compound is identical no matter the source of the compound. Thus, the reference shows that a commercial product meeting applicant’s claims was available before the effective filing date of applicant’s invention.
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655