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 .
Claims 1-5 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statements filed 12/8/2023 fail to fully comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because no copies for non-patent literature cited in the IDS were provided and the citations have therefore been lined through. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). All references listed in the IDS that are not provided are lined through and not considered.
Claim Objections
Claims 2-5 are objected to because of the following informalities: Claims 2-5 depend from claim 1. Claim 1’s preamble reads as “a pharmaceutical composition” while the dependent claims’ preamble reads as “The composition of claim 1…”. Dependent claims need to match the preamble of independent claim 1 as “The pharmaceutical composition of claim 1…”. Appropriate correction is required.
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.
Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite compositions containing natural products. This judicial exception is not integrated into a practical application because the claimed compositions comprise naturally-occurring psilocybin, psilocin, erinacines and hericenones which all are naturally contained within mushrooms, and other natural products like niacin which is a natural vitamin or lavender (Lavandula species), ginger (Zingiber officinale), turmeric (Curcuma longa) and rosemary (Rosmarinus officinalis). This judicial exception is not integrated into a practical application because it is a composition of natural products that are not markedly different from what is obtained in nature. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (i.e., a natural phenomenon/nature product) because nothing within the recited composition presents markedly different characteristics functionally and structurally already present within the individual natural components within the claimed compositions.
Based upon an analysis with respect to the claim as a whole, 1-5 do not recite something significantly different than a judicial exception.
The rationale for this determination is explained below:
The unpatentability of laws of nature/natural phenomenon was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 101 USPQ2d 1961 (March 20, 2012), and Association for Molecular Pathology v. Myriad Genetics, Inc. 106 USPQ2d 1972 (2013).
Consistent with the Subject Matter Eligibility Guidelines, the Examiner’s analysis is as follows:
a) the claimed invention is a composition of matter (Step 1),
b) psilocybin, psilocin, as well as Hericium erinaceus and niacin, are products of nature, which are not structurally nor chemically nor functionally different from the naturally-occurring counterparts (Step 2A, Prong One). Likewise, the vitamin niacin is also not structurally nor chemically nor functionally different from naturally-occurring niacin,
c) no claim integrates the invention into a practical application both individually and as taken as a whole (Step 2A, Prong Two), because functionally and structurally each component still reasonably retains its equivalent structure and function as found in nature at the amounts recited in the instant claims, and in which nothing within the claimed compositions reasonably functionally nor structurally change the characteristics of the components individually or as a whole.
For example, psilocybin is still a hallucinogenic at specific doses, and niacin at high levels still cause “flushing, tingling…”. Likewise, other naturally occurring plant or fungi extracts, or chemicals contained within (e.g., as it relates to Lion’s Mane), still reasonably possess their own equivalent functional and structural characteristics as when analyzed alone or when analyzed as a whole in the recited compositions.
d) Accordingly, the claim compositions as a whole fail to recite significantly more or that is markedly different than that which occurs in nature individually (Step 2B). As far as the additional components recited in claims 2-5, the analysis becomes that formulations or tablets, etc. are routinely and conventional practiced within the art, and that the tablet disintegrants which include sucrose, gelatin or starch (see the instant specification) is also a naturally-occurring pharmaceutically acceptable excipient; thereby, making claims equivalent to merely “apply it”. See MPEP 2106.05(f).
Lastly, addition of “pharmaceutically acceptable excipients” to any pharmaceutical composition is routine and conventionally practiced within the art (Step 2B); especially when the natural products like sucrose, gelatin and starch functionally a “buffering agent” and “tablet disintegrant”, and therefore, reasonably changes nothing, because these are all naturally occurring products.
In summary, all of the products of the instant claims are products of nature, which do not reasonably possess markedly different function and utility than the functions of the individual components found in nature. For example, page 1 and bottom of page 6 of the specification describe “constituents isolated from or contained within mushroom fruitbodies or mycelia…” [emphasis added], and “[c]ompounds naturally produced by the mycelium of psilocybian mushrooms and their mycelium includes (sic) baeocystin, norbaeocystin, N, N-dimethyl-tryptamine, 5-hydroxytryptamine (serotonin), 5-hydroxy-tryptonphan, psilocybin and psilocin”, and in which routine and conventional techniques are well known in the art for making such naturally-occurring psilocybin and/or psilocin-containing compositions, as well as those containing niacin in pharmaceutically acceptable excipients. Accordingly, the current claims simply rely on the recognition of naturally-occurring compounds and niacin components being isolatable from psilocybin mushrooms, etc., as are all naturally-occurring compounds contained within the other mushrooms, and in which all of which possess their own equivalent functional and structural properties because they are all products of nature.
In Mayo Collaborative Services it was held that:
"Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. [emphasis added].
The claims recite nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature/product of nature into a patent-eligible application of such a law, one must do more than simply observe and restate a law of nature while adding the words "apply it." As set forth in the decision,
"[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself,"
further, "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately [emphasis added]."
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Wieser et al, US2016/0206670 (IDS, 12/8/2023) and Sarris et al., 2013 (IDS, 12/8/2023) and Prousky 2010 (IDS, 12/8/2023).
Wieser teaches medicinal fungal preparations with medicinal potency. Wieser teaches that the administration of a daily dose of a composition including Lion’s Mane (Hericium erinaceus) reduces anxiety and depression in the tested subjects (see paragraphs 204 and 209 and claims 6, 17-18 and 20) and reads on the required component of instant claim 2. Wieser teaches using Lion’s Mane mushrooms, Hericium erinaceus, along with other mushrooms which include Reishi (Ganoderma lucidum), and Maitake (Grifola frondosa), (see paragraph 98-100) as required in instant claim 5. Wieser teaches that Maitake, Grifola frondosa, that key nutrient values include niacin (see paragraph 181) as in instant claim 1. Wieser teaches using fruit bodies and culture mycelia of the mushroom (see paragraphs 3, 114 and 124) and that there are extracts of Lions’ Main which are hericenones and erinacines (see paragraph 127) as in instant claim 2. Weiser teaches using pills or capsules to administer their mushroom extracts and compositions (see paragraphs 126-127). Wieser teaches using pharmaceutically acceptable oil for ingestion in humans (see paragraph 6) as in instant claim 3. While Weiser teaches a dose of 250mg of Lion’s Mane mushrooms, Hericium erinaceus, (see paragraph 128) and other mushroom components, Weiser does no teach using psilocybin or psilocin as required in the instant claims.
Sarris teaches using plant-based medicines to treat anxiety disorders. Sarris teaches that the plants include Psilocybe species (aka psilocybin or psilocin), Bacopa monnien, ayahuasca (Banisteriopsis caapi and Psychotria viridus and Cannabis species (see page 301, 2nd column; page 302, bottom of 2nd column; page 305, 1st column) as in instant claims 1 and 4. Sarris also teaches that Gotu Kola is used to treat anxiety (see page 307, 1st column). Sarris teaches that doses of 20-30mg/70kg (285-428g/kg, p.o.) of psilocybin produced psychological effects but that lower doses, including 200 g/kg, were successful in treating patients for anxiety and a dose of 250mg niacin (see page 312, Section 3.1 Psilocybe (Psilocybe spp.)) as required in instant claim 1. Sarris does not specifically teach the instantly claimed doses for the composition or individual components, nor Hericium erinaceus.
Prousky teaches that vitamin B3, niacin, has beneficial effects in depression (see abstract and page 139, bottom of 2nd column ) and reads on the required component of instant claim 1. Prousky teaches that practitioners have be using vitamin B3 therapeutically for more than 50 years to treat numerous neuropsychiatric conditions (see page 137, 2nd column, 2nd paragraph). Prousky teaches doses of niacin that encompass 300-600 mg (see table 2) and 3000-6000mg of no-flush niacin (inositol Hexaniacinate/Hexanicotinate) (see page 139, bottom of 1st column). Prousky does not teach using psilocybin or psilocin as required in the instant claims.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Wieser, Sarris and Prousky. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because both Weiser and Sarris teaches mushroom components that are known to help reduce anxiety and depression symptoms in a subject while Prousky teaches that vitamin B3, aka niacin, is shown to also treat depression.
Weiser and Sarris teach ranges of doses for treatments with the claimed components but not the specifically required doses. The art already teaches lower dosages, or micro dosages, as taught by Sarris that lower doses, including 200 g/kg, were successful in treating patients for anxiety. Therefore, one of ordinary skill in the art would be able to determine the best dose required to produce a positive effect without producing undesired side effects through routine optimization of best doses for the treatment of a subject with depression and anxiety (see MPEP § 2144.05). The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No.11,590,120. Although the claims at issue are not identical, they are not patentably distinct from each other because '120 claims a composition comprising psilocybin, psilocin, Hericium erinaceus and niacin at the same dosages as in the instant claims.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,471,450. Although the claims at issue are not identical, they are not patentably distinct from each other because '450 claims a composition comprising psilocybin, psilocin, Hericium erinaceus and niacin at the same dosages as in the instant claims.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,701,348. Although the claims at issue are not identical, they are not patentably distinct from each other because '348 claims a method with the same composition comprising psilocybin, psilocin, Hericium erinaceus and niacin at the same dosages as in the instant claims. Therefore, ‘348 anticipates the instantly claimed composition.
Conclusion
No claims are allowed.
Advisory Information
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675