Paul Stamets

Patent Trials and Appeals Board

Nov 25, 2020

2020006595 (P.T.A.B. Nov. 25, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
16/211,281 12/06/2018 Paul Edward Stamets 215261-9002-US03 1085
23409 7590 11/25/2020
MICHAEL BEST & FRIEDRICH LLP (Mke)
790 N WATER ST
SUITE 2500
MILWAUKEE, WI 53202
EXAMINER
HAYES, ROBERT CLINTON
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
11/25/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mkeipdocket@michaelbest.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PAUL EDWARD STAMETS
____________

Appeal 2020-006595
Application 16/211,281
Technology Center 1600
____________

BEFORE DONALD E. ADAMS, ERIC B. GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 6, 11, 20, and 21 (Appeal Br. 5). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Paul Edward
Stamets,” who “is the founder and owner of Fungi Perfecti LLC, a
Washington Limited Liability Company” (Appellant’s May 13, 2020 Appeal
Brief (Appeal Br.) 3).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to neuroregenerative compositions
based upon constituents isolated from or contained within mushroom
fruitbodies or mycelia, or the corresponding synthetic molecules, combined
with niacin” (Spec.2 1:9–11). Appellant’s claims 1 and 21 are reproduced
below:
1. A composition comprising:
0.1 mg to 0.6 mg of psilocybin, psilocin, or a combination
thereof;
1 mg to 20 mg of an erinacine, a hericenone, or a combination
thereof; and
1 mg to 50 mg of niacin.
(Appeal Br. 31.)
21. A composition comprising:
0.1 mg to 0.6 mg of psilocybin, psilocin, baeocystin,
norbaeocystin, salts thereof, or combinations thereof;
1 mg to 20 mg of an erinacine, a hericenone, or a combination
thereof;
1 mg to 50 mg of niacin; and
one or more pharmaceutically acceptable excipients comprising
solvents, buffering agents, antimicrobial preservatives,
antioxidants, suspension agents, a tablet or capsule diluent,
or a tablet disintegrant.
(Id. 35.)

2 Appellant’s December 6, 2018 Specification.
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Grounds of rejection before this Panel for review:
Claim 21 stands rejected under the written description provision of 35
U.S.C. § 112(a).
Claims 1–3, 6–8, 11–13, 20, and 21 stand rejected under 35 U.S.C.
§ 101.

WRITTEN DESCRIPTION:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s Specification fails to provide written
descriptive support for the claimed invention?
ANALYSIS
Examiner finds “that the formulations disclosed [on] pages 5-9 & 15
of [Appellant’s] [S]pecification fail to contemplate ‘baeocystin’ nor
‘norbaeocystin’ mg concentrations” (Ans. 5). In addition, Examiner finds
“that ‘equivalent molar’ amounts . . ., which must include amounts of a
solution, by definition, are not equivalent to mg amounts” (id.). Thus,
Examiner finds that Appellant’s Specification fails to provide written
descriptive support for the phrase “0.1 mg to 0.6 mg of . . . baeocystin,
norbaeocystin” as it appears in Appellant’s claim 21 (id.).
In response, Appellant contends that “[p]erhaps the term ‘equimolar’
is inaccurate with respect to mg quantities” (Appeal Br. 28). Examiner
emphasizes that this “is the issue” (see Ans. 11).
We acknowledge Appellant’s contention that its Specification
“expressly states that ‘equimolar amounts of analog’ or ‘amounts producing
equivalent functional effects’ may be used” and “the phrase ‘amounts
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producing equivalent functional effects’ makes clear that the same amount of
the analog may be used as psilocybin or psilocin, as is present in claim 21”
(Appeal Br. 28). As Examiner explains, however, “without reciting what
‘equivalent functional effect’ in the claims is to be assayed, one cannot
reasonably conclude what exact amount results in an ‘equivalent functional
effect’, especially when different amounts could be required for different
functions” (Ans. 11). In this regard, Examiner reasons that “any specific
functional characteristic of a compound is directly related to its actual
structure, and reasonably, different analogs possess different relative
functions and/or efficacies” (id.; cf. Reply Br.3 13 (Appellant contends that
its Specification defines ‘[t]he term ‘effective amount’ or ‘therapeutic
amount’ refers to an amount sufficient to have neurogenerative activity’”)
(alteration original)). We agree with Examiner’s rationale.
We acknowledge Appellant’s calculations regarding the conversion of
micromolar–to–microgram amounts (see Reply Br. 11–12). We decline,
however, Appellant’s invitation to consider this evidence and associated
contentions. See Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) (“[T]he reply brief [is not] an opportunity to make arguments
that could have been made in the principal brief on appeal to rebut the
Examiner’s rejections, but were not.”).
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s Specification fails to provide written descriptive

3 Appellant’s September 18, 2020 Reply Brief.
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support for the claimed invention. The rejection of claim 21 under the
written description provision of 35 U.S.C. § 112(a) is affirmed.

SUBJECT MATTER ELIGIBILITY:
ISSUE
Does the preponderance of evidence of record support Examiner’s
finding that Appellant’s claimed invention is directed to patent ineligible
subject matter?
PRINCIPLES OF LAW
Although 35 U.S.C. § 101 provides that “[w]hoever 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 . . .,” the Supreme Court has determined that there
are exceptions to what is patentable. Specifically, “laws of nature, natural
phenomena, and abstract ideas” are not eligible subject matter. See
Diamond v. Diehr, 450 U.S. 175, 185 (1981). To determine if claimed
subject matter is statutorily eligible in light of these judicial exceptions the
Supreme Court has articulated a two-step framework in Mayo Collaborative
Services v. Prometheus Labs., Inc., 566 U.S. 66 (2012), and later cases.
Specifically,
[f]irst, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts. . . . If so, we then ask,
“[w]hat else is there in the claims before us?” . . . To answer
that question, we consider the elements of each claim both
individually and “as an ordered combination” to determine
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whether the additional elements “transform the nature of the
claim” into a patent-eligible application.
Alice Corp. v. CLS Bank Int’l, 573 U.S. 216, 217 (2014) (quoting Mayo, 566
U.S. at 78). Thus, we must determine whether the claim is directed to a
judicially determined patent-ineligible concept and, if so, then ask if there is
anything in the claim that transforms it into patent-eligible subject matter.
On January 7, 2019 the USPTO published revised guidance on the
application of § 101 (see 2019 Guidelines4). After determining that claimed
subject matter falls within the four categories of patentable subject matter
identified in 35 U.S.C. § 101, the 2019 Guidelines provide a “revised step
2A,” which corresponds to the first step of the Alice/Mayo test articulated
above, to determine whether a claim is directed to a judicial exception (see
2019 Guidelines, 84 Fed. Reg. at 53–54). In a first prong of revised step 2A,
the Examiner must determine whether the claim recites a judicial exception
(see id. at 54). If a judicial exception is identified, the second prong requires
a determination of whether the judicial exception is integrated into a
practical application (see id.). If so, the inquiry ends and the claim is
determined to be directed to eligible subject matter under the 2019
Guidelines (see id. at 54 (“When the exception is so integrated [into a
practical application], then the claim is not directed to a judicial exception
(Step 2A: NO) and is eligible. This concludes the eligibility analysis.”)). If
not, the analysis continues to determine if the claim provides an inventive
concept (see id. at 56).

4 USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50–57 (2019).
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The USPTO subsequently updated the 2019 Guidelines (see October
2019 Update5). The October 2019 Update provides that when evaluating
whether a claim recites a judicial exception at the first prong of step 2A, the
claim is evaluated to determine whether it sets forth or describes a product of
nature in accordance with the guidance in MPEP §§ 2016.04(b) and (c),
including the markedly different characteristics analysis (see id. at 1).
ANALYSIS
(Step 1)
Appellant claims compositions of matter, a statutory category of
invention (see Appeal Br. 17 (“Each of independent claims 1, 6, 11, 20, and
21 is drawn to a composition of matter, which is a category of statutory
eligible subject matter”)). Therefore, we proceed to the next steps of the
analysis.
(Step 2A, Prong 1)
The composition of Appellant’s claim 1 comprises specified amounts
of (a) psilocybin, psilocin, or a combination thereof; (b) erinacine, a
hericenone, or a combination thereof; and (c) niacin (see Appeal Br. 31). As
Examiner explains, psilocybin, psilocin; erinacine and hericenone; and
niacin are products of nature, “which are naturally contained within different
mushrooms” (see Ans. 3–4 (citing Diet and Fitness Today6); see, e.g., Spec.
1:26–30 (Psilocybin and psilocin are obtained from “Psilocybe and
psilocybin containing mushrooms;” erinacine and hericenone are obtained

5 October 2019 Update: Subject Matter Eligibility, available at
https://www.uspto.gov/PatentEligibility.
6 Amount of Niacin in Mushrooms, available at
http://www.dietandfitnesstoday.com/niacin-in-mushrooms.php, last accessed
May 28, 2019.
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from “Hericium mushroom species;” and niacin, a product of nature,
“known as vitamin B3”); see also Appeal Br. 35 (Appellant concedes that
“[u]nder Step 2A, Prong One, claim 1 recites five natural products: (i)
psilocybin, (ii) psilocin (or the combination); (iii) erinacine, (iv) hericenone
(or the combination) and (v) niacin.”)).
In addition to comprising specified amounts of the natural products
discussed above, Appellant’s claim 21 further requires “one or more
pharmaceutically acceptable excipients comprising, [inter alia,] solvents”
(see Appeal Br. 35). Appellant discloses that pharmaceutically acceptable
excipients within the scope of its claimed invention include “solvents” such
as “water for injection” (Spec. 8:30–10:6–7). As Examiner explains, “the
diluent water is . . . naturally-occurring” (Ans. 4). For the foregoing reasons,
we are not persuaded by Appellant’s contention that Appellant’s
Specification does not list water as a suspension agent, tablet/capsule
diluent, or tablet disintegrant (Reply Br. 10).
In sum, Appellant’s claimed invention recites mixtures of nature-
based products. Because Appellant’s claimed invention recites nature-based
product limitations, the markedly different characteristics analysis is used to
determine if the nature-based product limitation is a product of nature
exception (see October 2019 Update 1).
Applying the markedly different characteristics analysis we find that
there is no indication on this record that mixing the nature-based products
according to Appellant’s claimed invention results in a transformation of the
products or that the claimed mixtures have properties not possessed by the
products in nature. See Ass’n for Molecular Pathology v. Myriad Genetics,
Inc., 569 U.S. 576, 591 (2013) (explaining that the bacterial mixture of Funk
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Brothers7 “was not patent eligible because the patent holder did not alter the
bacteria in any way.”); see also, In re Bhagat, 726 F. App’x 772, 779 (Fed.
Cir. 2018) (non-precedential) (“Applicant has not shown that the claimed
mixtures are a ‘transformation’ of the natural products, or that the claimed
mixtures have properties not possessed by these products in nature.”).
Appellant contends that its claimed compositions have “neurogenic
effects as discussed in the specification” (Reply Br. 6). Appellant failed,
however, to establish that the neurogenic effects of the nature-based
products of its claimed mixture have markedly different neurogenic effects
than the individual products themselves. See, e.g., Myriad Genetics, Inc.,
569 U.S. at 591 (explaining that the bacterial mixture of Funk Brothers “was
not patent eligible because the patent holder did not alter the bacteria in any
way.”). Thus, we are not persuaded by Appellant’s contention that its
claimed composition is patent eligible simply because it is the result of a
mixture of different nature-based products (see Reply Br. 7 (Appellant
contends that “the combination of a tryptamine compound (e.g., psilocybin)
with an erinacine or hericenone creates a new composition that is not found
in nature”); see id. at 9 (Appellant contends that its “claimed composition
is . . . a transformation (i.e., combination) . . . that, as a whole, has markedly
different characteristics from that found in nature”)).
For the foregoing reasons, we are not persuaded that Appellant’s
claimed mixtures are markedly different from the nature-based products and,
thus, we find that Appellant’s claims recite a judicial exception, i.e., a
product of nature.

7 See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131
(1948).
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(Step 2A, Prong 2)
Having determined that Appellant’s claims recite a judicial exception,
the Guidance requires an evaluation as to whether the claim as a whole
integrates the recited judicial exception into a practical application of the
exception. See Guidance, 84 Fed. Reg. at 54–55.
Appellant’s claims do not recite additional elements that are beyond
the judicial exception. Thus, Appellant’s claimed invention fails to integrate
the recited judicial exception into a practical application of the exception
(see Ans. 7 (“[T]here are no additional elements recited in the claims that
integrate the judicial exception . . . into a practical application . . . . Instead,
the claims merely recite a mixture of individual naturally-occurring
components, and nothing else additionally.”)).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that a “combination of natural products” that “are not produced
together by any known natural organism” results in “a practical application
of the judicial exception” (Appeal Br. 18–19). See, e.g., Myriad Genetics,
Inc., 569 U.S. at 591 (explaining that the bacterial mixture of Funk Brothers
“was not patent eligible because the patent holder did not alter the bacteria in
any way.”).
We are not persuaded by Appellant’s contention that the “specific
milligram quantities” of the nature-based products recited in its claims “do
not exist in nature” and, thus, “the claimed compositions recite additional
elements that integrate the judicial exception into a practical application”
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(Appeal Br. 19). As Example 308 explains, although “not discussed in the
opinion, it is noted that several of the claims held ineligible in Funk Brothers
recited specific amounts of the bacterial species in the mixture, e.g., claims
6, 7 and 13” (see Example 30 at 20, citing Funk Brothers, 333 U.S. at 128
n.1.). Thus, Appellant’s recitation of a mixture of specific amounts of
nature-based products does not support a finding of subject matter eligibility
on this record (cf. Appeal Br. 19; see also id. at 24–25; Reply Br. 9
(Appellant contends that its “claimed composition is . . . a practical
application of distinct natural products that, as a whole, has markedly
different characteristics from that found in nature”)).
(Step 2B)
Having determined that Appellant’s claims: (1) recite a judicial
exception and (2) do not integrate that exception into a practical application,
the Guidance requires that we evaluate whether Appellant’s claims: (a) add
a specific limitation beyond the judicial exception that is not “well-
understood, routine, conventional” in the field or (b) simply appends well-
understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception.
Guidance, 84 Fed. Reg. at 52–56.
As discussed above, Appellant’s claims do not recite additional
elements that are beyond the judicial exception (see Ans. 7 (“[T]here are no
additional elements recited in the claims that . . . ‘recites additional elements

8 Example 30 — Dietary Sweeteners, Subject Matter Eligibility Examples:
Life Sciences, 16–23, available at
https://www.uspto.gov/sites/default/files/documents/101_examples_
1to36.pdf.).
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that amount to significantly more than the judicial exception’ in the pending
claims . . . . Instead, the claims merely recite a mixture of individual
naturally-occurring components, and nothing else additionally.”)). For the
reasons set forth above, we are not persuaded by Appellant’s contentions
under Step 2B, which are the same contentions set forth above, with respect
to Step 2A, Prong 2 (see Appeal Br. 19 (“[T]he . . . aspects discussed above
under Prong Two are directly applicable in Step 2B”)).
For the reasons set forth above, we are not persuaded by Appellant’s
contention that its claimed invention is patent eligible in view of Funk
Brothers (see Appeal Br. 19–20).
We are not persuaded by Appellant’s contention that its claimed
invention is patent eligible in view of Diamond v. Chakrabarty, 447 U.S.
303 (1980) (see Appeal Br. 19–20). As Appellant explains, “Chakrabarty
transformed plasmids into Pseudomonas bacteria, thus creating both a
structural and functional change to the bacteria” (id. at 20). As discussed
above, on this record, Appellant failed to establish that its claimed mixture
of nature-based products have a different structure or function than those
possessed by the products in nature.
We are not persuaded by Appellant’s contention that its claimed
invention is patent eligible in view of Natural Alternatives International,
Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019); United
Cannabis Corp. v. Pure Hemp Collective Inc., Civil Action No. 18-cv-1922-
WJM-NYW, 2019 WL 1651846 (D. Colo. Apr. 17, 2019); and Ex parte
McCausland, 2016-004128, 2017 WL 4180263 (PTAB Aug. 31, 2017) (see
Appeal Br. 19–20). As Appellant explains, “[e]ach of Natural Alternatives,
United Cannabis, and Ex parte McCausland involved the use of natural
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product(s) in specific formulations that had different structures (e.g.,
combinations or formulations), functions, and utilities than the original
natural compounds” (id. at 20). As discussed above, on this record,
Appellant failed to establish that its claimed mixture of nature-based
products have a different structure, function, or utility than those possessed
by the products in nature.
Appellant also contends that its claimed invention is patent eligible in
view of Example 109 (see Appeal Br. 19–20). According to Appellant in
Example 10, “two species of bacteria that do not naturally coexist were
combined in milk, forming a patent eligible composition” (id. at 20; see
Reply Br. 6 (“the claimed compositions are combinations of naturally
occur[r]ing components that do not naturally coexist together, particularly in
the mass quantities specified”)). We are not persuaded. As Example 10
explains,
As described in the specification, when S. thermophilus and L.
alexandrinus are mixed, the two bacterial species have different
characteristics than either species does on its own, e.g., they act
together to ferment milk into a lower fat yogurt than either
bacteria can produce when individually mixed with the milk.
Thus, the mixture of the bacteria and milk has different
functional characteristics (lower fat content) than the naturally
occurring bacteria (or milk) by itself. These differences rise to
the level of a marked difference, and accordingly the claimed
starter culture is not a “product of nature” exception. Thus, the

9 Example 10 — Food, Subject Matter Eligibility Examples: Nature-Based
Products, 16–17, available at
https://www.uspto.gov/sites/default/files/documents/101_examples_
1to36.pdf.).
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claim is not directed to an exception (Step 2A: NO), and
qualifies as eligible subject matter.
(Example 10 at 17.) As discussed above, on this record, Appellant failed to
establish that its claimed mixture of nature-based products have different
characteristics than those possessed by the products in nature.
To be complete, we acknowledge Appellant’s contention that its
“claims recite specific doses and the specification describes the practical
application as a nootropic or nutraceutical composition for ‘neurogenesis,’
‘improving neurologic function,’ and ‘neurological health’” (Reply Br. 9).
We note, however, that Appellant claims a composition, not a method of
using the composition. In addition, as discussed above Appellant failed to
establish that its claimed mixture of nature-based products have a different
structure or function than those possessed by the products in nature. Thus,
on this record, Appellant’s claimed composition is patent ineligible.
CONCLUSION
The preponderance of evidence of record supports Examiner’s finding
that Appellant’s claimed invention is directed to patent ineligible subject
matter. The rejection of claims 1 and 21 under 35 U.S.C. § 101 is affirmed.
Claims 2, 3, 6–8, 11–13, and 20 are not separately argued and fall with claim
1.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
21 112(a) Written
Description
21
1–3, 6–8, 11–
13, 20, 21
101 Eligibility 1–3, 6–8,
11–13, 20,
21

Overall
Outcome
1–3, 6–8,
11–13, 20,
21

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED