The Procter & Gamble Company

Patent Trials and Appeals Board

Jun 1, 2020

2019005573 (P.T.A.B. Jun. 1, 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.
14/367,392 06/20/2014 Deborah Ruth Finlay 12322MC 1081
27752 7590 06/01/2020
THE PROCTER & GAMBLE COMPANY
GLOBAL IP SERVICES
CENTRAL BUILDING, C9
ONE PROCTER AND GAMBLE PLAZA
CINCINNATI, OH 45202
EXAMINER
BROWN, MINDY G
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
06/01/2020 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 DEBORAH RUTH FINLAY, TOMOHIRO HAKOZAKI,
CHARLES CARSON BASCOM, and HEATHER EILEEN MATHENY
Appeal 2019-005573
Application 14/367,392
Technology Center 1600
Before ULRIKE W. JENKS, TAWEN CHANG, and
JAMIE T. WISZ, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–5, 7–11, and 13–17. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

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. Appeal Br. 1.
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BACKGROUND
The Specification states that “[o]ne aspect of the invention relates to
novel ex-vivo skin models and screening methods for identifying tone agents
that may be suitable for use in cosmetic composition.” Spec. 1:5–8.

CLAIMED SUBJECT MATTER
The claims are directed to a screening method for identifying a test
agent as a potential skin tone agent. Claim 1 is illustrative:
1. A screening method for identifying a test agent as a potential
skin tone agent, comprising:
culturing a first human skin tissue sample at a temperature
of 33 °C to 37 °C, the first human skin tissue sample being
obtained only from a human donor rated from II to IV on the
Fitzpatrick Scale and comprising an epidermal layer and a
dermal layer;
contacting the first human skin tissue sample with the test
agent;
generating a transcriptional profile from the first human skin
tissue sample, wherein the transcriptional profile comprises
data related to transcription of at least two genes selected
from propriomelancortin (POMC), melanocortin 1 receptor
(MClR), microphthalmia-associated transcription factor
(MITF), tyrosinase (TYR), tyrosine related protein 1
(TYRPl), dochrachrome tautaomerase (DCT), transforming
growth factor 1 (TGFB 1), and endothelin 1 (ENDl); and
identifying the test agent as a potential skin tone agent when
the at least two genes show a decrease in expression level
with a statistical significance of p ≤ 0.1 in comparison to a
control.
Appeal Br. 8 (Claims App.).

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REJECTION(S)
Claims 1–5, 7–11, and 13–17 are rejected under 35 U.S.C. § 101 as
being directed to a judicial exception (i.e., a law of nature, a natural
phenomenon, or an abstract idea) to patent-eligible subject matter, without
significantly more.

OPINION
A. Issue(s)
The Examiner concludes that “[t]he claims recite generating a
transcriptional profile for a group of genes and identifying a potential test
agent based on the comparison of the transcriptional profile to a control” and
that “[t]hese steps are mental processes of gathering data about a group of
genes and comparing that data to a control.” Ans. 4. The Examiner further
concludes that the claims “do not recite a practical application because the
claims do not recite any step that utilize the information obtained by the data
gathering. . . . For example, the skin tone agent is not used or
administered.” Id. Finally, the Examiner finds that the claims do not “recite
additional elements that amount to significantly more than the judicial
exception,” because the additional steps of “culturing a human skin sample
and contacting the skin sample with the test agent” are “routine and
conventional in the art,” and “[d]etecting DNA or an enzyme in a sample,
amplifying or sequencing nucleic acid structures, or hybridizing gene probes
are all recited in the MPEP as well-understood, routine, conventional
activity.” Id. at 5.
Appellant contends that the Examiner failed to identify the specific
category of abstract idea recited in the claim and also failed to analogize the
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pending claims to claims previously found by courts to be directed to
judicial exceptions to patent-eligible subject matter. Appeal Br. 3, 5. In the
Reply Brief, Appellant contends that “generating a transcriptional profile
from a human skin tissue sample and conducting the complex statistical
analysis needed to identify a potential skin care agent is not something that
can be performed in the human mind.” Reply Br. 2.
Appellant contends that, assuming that the claims recite a judicial
exception, the claims integrate the judicial exception into a practical
application because (1) the claimed method “reflects an improvement in the
cosmetic skin care field,” (2) the claims “implement[] the recited limitations
with a particular article (i.e., skin sample) that is integral to the claim,” and
(3) “generating the transcriptional profile in claim 1 requires the destruction
of cells to extract mRNA,” which constitutes “transformation of an article to
a different state or thing.” Appeal Br. 4–5. Appellant contends that the
Examiner’s analysis regarding whether the claims recite a practical
application is impermissibly conclusory. Reply Br. 2.
Finally, Appellant contends that, even assuming that the claims are
directed to judicial exceptions to patent-eligible subject matter, the Examiner
has not established that the claims do not “amount[] to significantly more
than a patent upon the ineligible concept itself,” because the Examiner has
not shown that additional elements in the claim are well-known, routine, and
conventional. Appeal Br. 5–6; see also Reply Br. 2–3.
The dispositive issue with respect to this rejection is whether, to the
extent the claims are directed to a judicial exception to patent-eligible
subject matter, the additional elements of the claims, individually or in an
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ordered combination, amounts to significantly more than the judicial
exception.
B. Analysis
We analyze this case under the framework set forth by the Supreme
Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566
U.S. 66 (2012), and elaborated by Alice Corp. Pty. Ltd. v. CLS Bank Int’l,
573 U.S. 208 (2014):
First, we determine whether the claims at issue are directed to
[laws of nature, natural phenomena, or abstract ideas]. 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
whether additional elements “transform the nature of the claim”
into a patent-eligible application. [The Supreme Court has]
described step two of this analysis as a search for an
“ ‘inventive concept’ ”—i.e., an element or combination of
elements that is “sufficient to ensure that the patent in practice
amounts to significantly more than a patent upon the [ineligible
concept] itself.”
Alice, 566 U.S. at 217–218 (second and fourth alterations original) (citations
omitted).

Mayo Step One: Whether Claims Are Directed to Patent-Ineligible Concept
We begin with the first step of the Mayo test, namely whether a claim
is “directed to” a patent-ineligible concept. On January 7, 2019, the Director
of the USPTO issued the “2019 Revised Patent Subject Matter Eligibility
Guidance” (“Revised Guidance”), which provides further details regarding
how the Patent Office analyzes patent-eligibility questions under 35 U.S.C.
§ 101. 84 Fed. Reg. 50–57 (Jan. 7, 2019). Under the Revised Guidance, the
first step of the Mayo/Alice test (i.e., Step 2A of the Revised Guidance) is “a
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two-pronged inquiry.” Id. at 54. In prong one, we evaluate whether the
claim recites a judicial exception, such as laws of nature, natural
phenomena, or abstract ideas. Id. If the claim recites a judicial exception,
the claim is further analyzed under prong two, which “evaluate[s] whether
the claim recites additional elements that integrate the exception into a
practical application of that exception.” Id.
The Revised Guidance explains that, “[i]f the recited exception is
integrated into a practical application of the exception, then the claim is
eligible at Prong Two of . . . Step 2A [of the Revised Guidance].” 84 Fed.
Reg. at 54. However, if a claim recites a judicial exception and is not
integrated into a practical application of the exception, the claim is directed
to patent-ineligible subject matter, and we move to the second step of the
Mayo/Alice analysis, i.e., whether the claim recites “an element or
combination of elements that is ‘sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the [ineligible
concept] itself.’” Alice, 566 U.S. at 217–218 (citation omitted).

First Prong of Revised Guidance Step 2A
With respect to the first prong of Step 2A of the Revised Guidance,
we agree with the Examiner that claim 1 recites a patent-ineligible judicial
exception. In particular, as the Examiner explains, the claim recites a mental
process, i.e., “identifying the test agent as a potential skin tone agent when
the at least two genes show a decrease in expression level with a statistical
significance of p ≤ 0.1 in comparison to a control.” Ans. 4. Additionally,
the claim also recites a law of nature, specifically the correlation between a
test agent’s ability to act as “a potential skin tone agent” and the test agent’s
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ability to “decrease . . . expression level” of “at least two genes selected
from” the recited list of genes, “with a statistical significance of p ≤ 0.1 in
comparison to a control.” Appeal Br. 8 (Claims App.).
In Mayo, for instance, the Supreme Court found that a claim was
directed to a natural law, where the claim required administering a drug and
determining the levels of a metabolite following administration, where the
level of metabolite was indicative of a need to increase or decrease the
dosage of the drug. See Mayo Collaborative Services v. Prometheus Labs.,
Inc., 566 U.S. 66, 74 (2012). Here, similarly, the claims require contacting a
human skin tissue sample with a test agent, wherein a decrease in expression
level of at least two genes selected from the recited list, with a statistical
significance of p ≤ 0.1 in comparison to a control, was indicative of the test
agent’s potential to act as a skin tone agent. Likewise, in In re BRCA1 &
BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir.
2014), our reviewing court held that comparing nucleotide sequences and
determining the existence of alterations is an abstract mental process. Id. at
763. The pending claims recite a similar comparison of gene expression
levels to determine whether expression levels were decreased.
We are not persuaded by Appellant’s arguments to the contrary. As to
Appellant’s contention that no specific category of abstract idea was
identified in the rejection, Appeal Br. 3, we note that the claims recite a
mental process, which is identified in the Revised Guidance as a category of
abstract ideas, 84 Fed. Reg. at 52, as well as a law of nature. As to
Appellant’s contention that the pending claims have not been analogized to
claims previously found by courts to be patent-ineligible, we note that, as
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discussed above, the claims on appeal are similar to those found to be
patent-ineligible in Mayo and In re BRCA1.
Finally, Appellant argues that “generating a transcriptional profile . . .
and conducting the complex statistical analysis needed to identify a potential
skin care agent” cannot be performed in the human mind. Reply Br. 2.
While we agree that generating a transcriptional profile is not solely a
mental process, identification of a test agent as a potential skin tone agent
based on characteristics of the generated transcriptional profile (i.e.,
decrease in expression level of certain genes) is a mental process. Appellant
has not persuasively explained why determination of statistical significance
cannot be performed in the human mind.

Second Prong of Revised Guidance Step 2A
Prong two of Step 2A of the Revised Guidance “evaluate[s] whether
[a] claim recites additional elements that integrate [a judicial] exception [to
patent-eligible subject matter] into a practical application of that exception.”
84 Fed. Reg. at 54. However, as discussed in the next section of our
opinion, assuming the claims are not patent-eligible under this prong, we
nevertheless find that the Examiner has not established a prima facie case
under the second step of the Mayo/Alice analysis. Thus, we need not
determine whether the pending claims integrate the recited mental process
and law of nature into a practical application.

Mayo Step Two: Whether Claim 1 Recites “Significantly More”
Claims are patent-eligible under the second step of the Mayo/Alice test
“when the claim limitations involve more than performance of well-
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understood, routine, [and] conventional activities previously known to the
industry.” Berkheimer v. HP Inc., 881 F.3d 1360, 1367 (Fed. Cir. 2018)
(internal quotation marks omitted).) “The question of whether a claim
element or combination of elements is well-understood, routine and
conventional to a skilled artisan in the relevant field is a question of fact.”
Id. at 1368. Moreover, “[w]hether a particular technology is well-
understood, routine, and conventional goes beyond what was simply known
in the prior art,” and “[t]he mere fact that something is disclosed in a piece
of prior art . . . does not mean it was well-understood, routine, and
conventional.” Id.
Because the Examiner has not sufficiently shown that the additional
limitations of the claims constitute well-understood, routine, and
conventional activity, we find that the Examiner has not established a prima
facie case that the claims are patent-ineligible under this step of the
Mayo/Alice analysis.
The elements of claim 1 that are not a mental process or a statement of
the natural law are (1) “culturing a . . . human skin tissue sample at a
temperature of 33 °C to 37 °C, the . . . sample being obtained only from a
human donor rated from II to IV on the Fitzpatrick Scale and comprising an
epidermal layer and a dermal layer”; (2) “contacting the first human skin
tissue sample with the test agent”; and (3) “generating a transcriptional
profile from the . . . sample, wherein the transcriptional profile comprises
data related to transcription of at least two genes selected from” the list
recited in claim 1. Appeal Br. 8 (Claims App.).
The Examiner asserts that “the steps of culturing a human skin sample
and contacting the skin sample with the test agent . . . are routine and
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conventional in the art and do not amount to significantly more than the
judicial exception” and that, similarly, “[d]etecting DNA or an enzyme in a
sample, amplifying or sequencing nucleic acid structures, or hybridizing
gene probes are all recited in the MPEP as well-understood, routine,
conventional activity.” Ans. 5, 7. The Examiner also asserts that the
specific limitations relating to sample types and culturing conditions are
merely “matter[s] of experimental design” and “do not add something
significantly more to the claims.” Id. at 6.
The Examiner cites no authority, and we are not aware of any, that
matters of experimental design are necessarily well-understood, routine and
conventional, or that such matters cannot add something significantly more
to the claims. The Examiner provides no other evidence that the limitations
relating to the culturing step are well-understood, routine, and conventional.
Likewise, although the Examiner cites to the MPEP for the proposition that
“generating a transcriptional profile” does not amount to significantly more
than the recited judicial exception because “detecting DNA or an enzyme in
a sample, amplifying or sequencing nucleic acid structures, or hybridizing
gene probes” are all well-understood, routine, and conventional, the
Examiner does not provide sufficient analysis as to whether this limitation,
considered as an ordered combination with the other additional claim
limitations, constitutes routine and conventional activity.
It is the Examiner’s burden to establish, for the purposes of this
rejection, that the elements of the claims were routine and conventional. See
MPEP § 1213.02 (“The Board’s primary role is to review the adverse
decision as presented by the Examiner, and not to conduct its own separate
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examination of the claims.”). Accordingly, the rejection of the claims under
35 U.S.C. § 101 is reversed.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 7–11,
13–17
101 Eligibility 1–5, 7–11,
13–17

REVERSED