The Procter & Gamble Company

Patent Trials and Appeals Board

Dec 31, 2020

2020002777 (P.T.A.B. Dec. 31, 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.
15/590,598 05/09/2017 Qing NMN STELLA 14331 1460
27752 7590 12/31/2020
THE PROCTER & GAMBLE COMPANY
GLOBAL IP SERVICES
CENTRAL BUILDING, C9
ONE PROCTER AND GAMBLE PLAZA
CINCINNATI, OH 45202
EXAMINER
SALMON, KATHERINE D
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
12/31/2020 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):
centraldocket.im@pg.com
mayer.jk@pg.com
pair_pg@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte QING NMN STELLA,
MICHAEL KEITH ROBINSON, and KEVIN JOHN MILLS
____________

Appeal 2020-002777
Application 15/590,598
Technology Center 1600
____________

BEFORE DONALD E. ADAMS, JEFFREY N. FREDMAN, and
DEBORAH KATZ, 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, 8, 12, and 16 (Final Act.2 2).3 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

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 “The Procter
& Gamble Company” (Appellant’s September 18, 2019 Appeal Brief
(Appeal Br.) 1).
2 Examiner’s April 18, 2019 Final Office Action.
3 Pending Claims 7, 9–11, 13, and 14 stand withdrawn from consideration
(Final Act. 2).
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STATEMENT OF THE CASE
Appellant’s discloses “methods useful for the screening and
generation of potential skin moisturizing actives for the treatment of dry
skin” (Spec.4 2:32–33). Appellant’s independent claims 1 and 16 are
reproduced below:
1. A screening method for identifying a cosmetic test agent as a
skin moisturizing agent, the method comprising:
a) contacting a skin tissue sample with a cosmetic test
agent;
b) generating a transcriptional profile for the skin tissue
sample, wherein the transcriptional profile comprises
data related to the transcription of at least two genes
selected from the group consisting of v-rel avian
reticuloendotheliosis viral oncogene homolog gene
(REL); integrin beta-1 gene (ITGB1); transforming
growth factor beta receptor II gene (TGFBR2); YY1-
associated protein 1 gene (YY1AP1); mitogen-activated
protein kinase 3 gene (MAP3K); caspase 3, apoptosis-
related cysteine peptidase gene (CASP3); telomerase
reverse transcriptase gene (TERT); mdm2 p53 binding
protein homolog gene (MDM2); and laminin, gamma 2
gene (LAMC2);
c) comparing the transcriptional profile for the skin tissue
sample to a positive control transcriptional profile; and
d) identifying the cosmetic test agent as a skin
moisturizing agent for human skin when the
transcriptional profile for the skin tissue sample and
the positive control transcriptional profile are
concordant.
(Appeal Br. 16.)

4 Appellant’s May 9, 2017 Specification.
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16. A method of formulating a moisturizing skin care
composition for human skin, comprising:
a) identifying a cosmetic test agent as skin moisturizing
agent according to the screening method of claim 1; and
b) combining an effective amount of the cosmetic test
agent with a dermatologically acceptable carrier to
produce the skin care composition.
(Id. at 17–18.)
Due to a restriction requirement, the scope of the at least two genes set
forth in step (b) of Appellant’s claimed method is limited to v-rel avian
reticuloendotheliosis viral oncogene homolog gene (REL) and integrin beta-
1 gene (ITGB1) (see generally, Final Act. 2). Therefore, we review the
merits of Appellant’s claimed methods in the context of generating a
transcriptional profile for the skin tissue sample, wherein the transcriptional
profile comprises data related to the transcription of REL and ITGB1. See
Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).

Grounds of rejection before this Panel for review:
Claims 1–6, 8, 12, and 16 stand rejected as containing an improper
Markush group
Claims 1–6, 8, 12, and 16 stand rejected under the enablement
provision of 35 U.S.C. § 112(a).
Claims 1–6, 8, and 12 stand rejected under 35 U.S.C. § 101.

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IMPROPER MARKUSH GROUPING:
ISSUE
Does the evidence of record support Examiner’s conclusion that
Appellant’s claims include an improper Markush grouping?
ANALYSIS
“A ‘Markush’ claim recites a list of alternatively useable species”
regardless of format. 76 Fed. Reg. 7162, 7166 (2011) (footnote omitted).
“A Markush claim contains an ‘improper Markush grouping’ if: (1) The
species of the Markush group do not share a ‘single structural similarity,’ or
(2) the species do not share a common use.” Id. “Members of a Markush
group share a ‘single structural similarity’ when they belong to the same
recognized physical or chemical class or to the same art-recognized class.”
Id. “Members of a Markush group share a common use when they are
disclosed in the specification or known in the art to be functionally
equivalent.” Id.
Although, as Examiner asserts, individual sequences differ because
they are drawn to different genes, we agree with Appellant’s contention that
the nucleic acid sequences recited in the rejected claims are reasonably
understood to contain a nucleic acid backbone, which is a single structural
similarity and also share a common use in assessing skin moisturization
agents (see Appeal Br. 2; Reply Br.5 1–2; cf. Final Act. 4; Ans.6 4).
CONCLUSION
The evidence of record fails to support Examiner’s conclusion that
Appellant’s claims include an improper Markush grouping. The rejection of

5 Appellant’s February 27, 2020 Reply Brief.
6 Examiner’s December 31, 2019 Answer.
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claims 1–6, 8, 12, and 16 as containing an improper Markush group is
reversed.

ENABLEMENT:
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention.
ANALYSIS
Examiner finds that “while being enabling for methods of contacting
skin tissue samples with a cosmetic test agent and generating a
transcriptional profile, does not reasonably provide enablement for
identifying the agent as a moisturizing agent and formulating a moisturizing
composition” (Final Act. 5). In this regard, Examiner finds that Appellant’s
Specification fails to “provide predictable guidance for methods drawn to
any skin sample using any cosmetic test agent,” “for the identification of any
cosmetic agent as a skin moisturizing agent,” or for formulating moisturizing
skin care composition based on the identification, according to Appellant’s
claimed invention, of a cosmetic agent as a skin moisturizing agent (id. at 6;
see also id. at 7 (citing Wu7 and Evans8) (Examiner find that Appellant’s
Specification “does not provide clear guidance as to how to determine and
identify a cosmetic test agent based upon such determination in comparison
to a control and further, does not provide . . . [for formulating a moisturizing
skin care composition] based on such determination); Ans. 5 (Examiner

7 Wu, Analyzing gene expression data from DNA microarrays to identify
candidate genes, 195 J. Pathol. 53–65 (2001).
8 Evans et al., Moving towards individualized medicine with
pharmacogenomics, 429 Nature 464–68 (2004).
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finds that Appellant’s Specification “has not provided any guidance as to the
expression differences in the recited genes in samples such as ones with
disease, infection, or fungus and how these effect the screening of the
agents”)). Thus, Examiner concludes that it would require undue
experimentation to practice Appellant’s claimed invention (see Final Act. 9–
10). We are not persuaded.
As Appellant explains, its Specification provides an enabling
disclosure of a screening method for identifying a cosmetic test agent as a
skin moisturizing agent, wherein a skin tissue sample, as defined at page 7 of
Appellant’s Specification, is contacted with a cosmetic test agent, as defined
at pages 7–9 of Appellant’s Specification, to generate a transcriptional
profile for the skin tissue that comprising data related to the transcription of
REL and ITGB1 (see Appeal Br. 4–8). Appellant discloses that “reference
gene expression measurements can be from control samples that include
reference cells exposed to a positive control agent, such as known skin
moisturizing actives. Non-limiting examples of such known skin
moisturizing actives that can be used as a positive control agent include
glycerin, zinc pyrithione (ZPT), monoolein, and olivem1000” (Spec. 14–18).
Thus, we are not persuaded by Examiner’s intimation that a person of
ordinary skill in this art would not appreciate that Appellant enables the
foregoing steps, such that the results of a transcriptional provide for a skin
tissue sample may be compared to a positive control transcriptional profile,
that a cosmetic test agent may be identified as a skin moisturizing agent for
human skin when the transcriptional profile for the skin tissue sample and
positive control transcriptional profile are concordant, and that such an
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identified skin moisturizing agent can be formulated in a skin moisturizing
composition (see Appeal Br. 4–8; cf. Final Act. 5–10; Ans. 4–6).
We recognize Examiner’s reliance on Wu and Evans, but find that
Examiner failed to identify a disclosure in either reference that refutes
Appellant’s disclosure of the use of transcriptional profiles of REL and
ITGB1 to determine whether a cosmetic agent within the scope of
Appellant’s claimed invention is a skin moisturizing agent. We also
appreciate Examiner’s finding that the scope of the term skin tissue sample,
as set forth in Appellant’s claimed methods, may read on “samples such as
ones with disease, infection, or fungus” (see e.g., Final Act. 9–10). We find,
however, that Examiner failed to establish an evidentiary basis on this record
to support a conclusion that these types of skin samples would not be
capable of identifying a cosmetic test agent as a skin moisturizing agent.
Further, even if Appellant’s claimed invention included inoperable
embodiments, Examiner failed to establish an evidentiary basis on this
record to support a finding that the number of inoperable embodiments
would have been so significant that a person of ordinary skill in this art
would effectively be forced to experiment unduly in order to practice the
claimed invention. See Atlas Powder Co. v. E.I. DuPont De Nemours &
Co., 750 F.2d 1569, 1576–77 (Fed. Cir. 1984).
CONCLUSION
The evidence of record fails to support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention.
The rejection of claims 1–6, 8, 12, and 16 under the enablement provision of
35 U.S.C. § 112(a) is reversed.

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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
A. Section 101
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first
determine what concept the claim is “directed to.” See Alice, 573 U.S. at
219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
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mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Court held that “a claim drawn to subject matter otherwise statutory does not
become nonstatutory simply because it uses a mathematical formula.”
Diehr, 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as
nothing more than a process for molding rubber products and not as an
attempt to patent a mathematical formula.”). Having said that, the Court
also indicated that a claim “seeking patent protection for that formula in the
abstract . . . is not accorded the protection of our patent laws, and this
principle cannot be circumvented by attempting to limit the use of the
formula to a particular technological environment.” Id. (citation omitted)
(citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that
an application of a law of nature or mathematical formula to a known
structure or process may well be deserving of patent protection.”).
If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, where “we must examine the
elements of the claim to determine whether it contains an ‘inventive
concept’ sufficient to ‘transform’ the claimed abstract idea into a patent-
eligible application.” Alice, 573 U.S. at 221 (internal quotation marks
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omitted). “A claim that recites an abstract idea must include ‘additional
features’ to ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo,
566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[]
fail[s] to transform that abstract idea into a patent-eligible invention.” Id.
B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“Guidance”).9 “All USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance.” Id. at 51; see also October
2019 Update at 1.
Under the Guidance and the October 2019 Update, we first look to
whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)
(9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).10

9 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
10 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
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Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) 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.
ANALYSIS
(Step 1)
We first consider whether the claimed subject matter falls within the
four statutory categories set forth in § 101, namely “[p]rocess, machine,
manufacture, or composition of matter.” Guidance, 84 Fed. Reg. at 53–54;
see 35 U.S.C. § 101. Appellant’s claims are directed to methods, i.e.
processes. Thus, Appellant’s claims are directed to statutory subject matter
(see, e.g., Appeal Br. 16; see also Final Act. 16 (Examiner finds, “[i]n the
instant case the claims are drawn to a method comprising identifying a
cosmetic test agent. Thus the method passes the first inquiry”)). Therefore,
we proceed to the next steps of the analysis.

practical application. See Guidance — Section III(A)(2), 84 Fed. Reg. at
54–55.
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(Step 2A, Prong 1)
The screening method of Appellant’s claim 1 comprising, inter alia,
the steps of:
b) generating a transcriptional profile for the skin tissue
sample, wherein the transcriptional profile comprises
data related to the transcription of at least two genes
selected from the group consisting of . . . [REL] and
[ITGB1];
c) comparing the transcriptional profile for the skin tissue
sample to a positive control transcriptional profile; and
d) identifying the cosmetic test agent as a skin
moisturizing agent for human skin when the
transcriptional profile for the skin tissue sample and
the positive control transcriptional profile are
concordant.
(Appeal Br. 16.) Examiner finds that Appellant’s claimed invention recites
the steps of generating, comparing, and identifying, i.e. mental steps, which
are abstract ideas under the Guidance (see Ans. 6). See also 84 Fed. Reg. at
52–55. We find no error in Examiner’s finding that Appellant’s claim 1
“recite[s] an abstract idea” (Ans. 6).
The Examiner also finds the claims are drawn to a natural
phenomenon (see Ans. 6). We agree that claim 1 recites a natural law where
agents are identified as skin moisturizing based on a correlation to
transcriptional profiles of particular genes. “The claimed invention is
focused on screening for a natural law.” INO Therapeutics LLC. v. Praxair
Distribution, Inc., 782 Fed. Appx. 1001, 1008 (Fed. Cir. 2019). A

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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. The Guidance explains that
“courts have . . . identified examples in which a judicial exception has not
been integrated into a practical application,” such as when “an additional
element adds insignificant extra-solution activity to the judicial exception.”
84 Fed. Reg. at 55 (footnote omitted).
On this record, Appellant’s claim 1 includes the following additional
step, i.e., additional element:
a) contacting a skin tissue sample with a cosmetic test agent.
(See Appeal Br. 16.) This step, however, does no more than initiate the
gathering of data for use in conjunction with the mental process set forth in
the remaining steps of claim 1 (see MPEP § 2106.05(g)). Thus, this
remaining step of Appellant’s claimed invention is not sufficient to integrate
the judicial exception into a practical application.
(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.
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On this record, Examiner finds that “the step of contacting a skin
tissue sample with a cosmetic test agent is a routine step in the prior art and
is a general methodology” (Ans. 6 (citing Spec. 2); see also Ans. 6–7
(Examiner notes “that the step could be read . . . generally as placing lotion
on the ski[n] and therefore would read on any contacting of the sample with
an agent including providing lotion to a region of the skin”)). Thus,
Appellant “simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception.” See 84 Fed. Reg. at 52–56.
In sum, we find that Appellant’s claimed invention lacks subject
matter eligibility.
Appellant contends that Examiner failed to “provide the express
written reasoning required by the guidelines, and thus has not properly
shown that the additional elements recited in pending claim 1 are well-
known, routine, conventional activity” (Appeal Br. 15; see generally Reply
Br. 4). Stated differently, Appellant contends that the application of a
cosmetic agent to skin was not well-known, routine, conventional activity.
Because the cosmetic industry relies on the application of cosmetic agents to
skin, we are not persuaded by Appellant’s contention that such a process was
not well-known, routine, conventional activity.
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 claim 1 under 35 U.S.C. § 101 is affirmed. Claims
2–6, 8, and 12 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
1–6, 8, 12, 16 Improper Markush 1–6, 8, 12,
16
1–6, 8, 12, 16 112(a) Enablement 1–6, 8, 12,
16
1–6, 8, 12 101 Eligibility 1–6, 8,
12

Overall
Outcome
1–6, 8,
12
16

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-IN-PART