Ex Parte HAKOZAKI et al

Patent Trial and Appeal Board

Dec 4, 2018

13851858 (P.T.A.B. Dec. 4, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/851,858 03/27/2013
27752 7590 12/06/2018
THE PROCTER & GAMBLE COMPANY
Global IP Services
Central Building, C9
One Procter and Gamble Plaza
CINCINNATI, OH 45202
FIRST NAMED INVENTOR
Tomohiro HAKOZAKI
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
12359M 7753
EXAMINER
WHALEY, PABLO S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
12/06/2018 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
pair_pg@firsttofile.com
mayer.jk@pg.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KA TSUYUKI TERUY AMA
Appeal2017-010405
Application 13/851,858 1
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 3, 6, 9--11,
and 15-20 (Final Act. 2 2). Examiner entered rejections under 35 U.S.C.
§ 101; the written description provision of 35 U.S.C. § l 12(a); and 35
U.S.C. § 112(b). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies "The Procter & Gamble Company" as the real party in
interest (App. Br. 1).
2 Examiner's July 11, 2016 Final Office Action.
Appeal2017-010405
Application 13/851,858
STATEMENT OF THE CASE
Appellant's disclosure relates to "methods, systems and models useful
for generating potential new skin-active agents efficacious for the treatment
of skin conditions such as hyperpigmentation" (Spec. 7: 17-19). Claims 1
and 10 are representative and reproduced below:
1. A method of constructing a database for use in identifying
connections between perturbagens and genes associated with
skin tone, comprising:
(a) providing a gene expression profile for a control human cell,
wherein the control cell is from a human cell line selected from
the group consisting of keratinocyte, fibroblast, melanocyte and
melanoma cell lines;
(b) generating a gene expression profile for a human cell
exposed to at least one perturbagen, wherein the perturbagen
comprises a skin active agent that modifies skin pigmentation,
and wherein the cell is from the same cell line as the control
cell;
( c) identifying genes differentially expressed in response to the
at least one perturbagen by comparing the gene expression
profiles of (a) and (b );
( d) creating an ordered list comprising identifiers representing
the differentially expressed genes, wherein the identifiers are
ordered according to the differential expression of the genes;
( e) storing the ordered list as an instance on a non-transitory
computer readable medium, wherein the instance includes
metadata identifying the cell line from the selection in (a); and
( f) constructing a database of stored instances by repeating (a)
through ( e) for between about 50 and about 50,000 instances,
wherein the at least one perturbagen of step (b) is different
qualitatively or quantitatively for each instance, and steps c, d,
e, and fare performed using a programmable computer.
(App. Br. 3 15-16.)
3 Appellant's February 2, 2017 Appeal Brief.
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Application 13/851,858
10. A method of implementing the database of Claim 1 to
identify at least one putative skin active agent for treating a skin
hyperpigmentation condition, the method comprising:
(a) querying the database with a gene expression
signature, wherein
(i) querying comprises comparing the gene
expression signature to each stored instance and
assigning a connectivity score to each comparison,
wherein the connectivity score is a combination of
an up-score and a down-score, the up-score
representing the correlation between upregulated
genes of the gene signature and the stored instance
and the down-score representing the correlation
between the down-regulated genes of the gene
signature and the stored instance,
(ii) the gene expression signature represents genes
differentially expressed in cells derived from skin
affected with a skin hyperpigmentation condition
or genes differentially expressed in cells treated
with at least one benchmark skin active agent
having known efficacy in treating a skin
hyperpigmentation condition, and
(iii) the gene expression signature is derived from
the same cell line as the instances; and
(b) identifying a perturbagen associated with the instance
as a putative skin active agent for treating the
hyperpigmentation condition when the connectivity score
is positive, and identifying the perturbagen associated
with the instance as a putative skin active agent for
darkening skin when the connectivity score is negative.
(Id. at 16-17.)
Grounds of rejection before this Panel for review:
Claims 1, 3, 6, 9--11, and 15-20 stand rejected under 35 U.S.C.
§ 112(b).
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Application 13/851,858
Claims 1, 3, 6, 9--11, and 15-20 stand rejected under the written
description provision of 35 U.S.C. § 112(a).
Claims 1, 3, 6, 9--11, and 15-20 stand rejected under 35 U.S.C. § 101.
Definiteness:
ISSUE
Does the preponderance of evidence support Examiner's conclusion
that the phrase "skin active agent that modifies skin pigmentation," as set
forth in Appellant's claims, is indefinite?
ANALYSIS
Examiner finds the scope of the phrase "skin active agent that
modifies skin pigmentation," as it appears in Appellant's claims, to be
unclear (Final Act. 10). According to Examiner, Appellant's Specification
"does not provide any limiting definition for this [phrase] that would serve
to clarify [its] scope" (id.; see Ans. 4 13). Appellant discloses, however, that
"[ s ]kin active agents which modify skin pigmentation are known in the art"
(Spec. 18:29; see App. Br. 13). In addition, Appellant discloses several such
skin pigmentation modifying agents and "biological targets that
pigmentation modifying skin active agents are known to modulate" (see
Spec. 18:29--19:6; see App. Br. 13-14). Thus, on this record the claimed
active agents and biological targets were known in the art. We, therefore,
find that the preponderance of evidence falls in favor of Appellant.
[C]laims may use language that those skilled in the art
understand without the need for explicit, detailed definitions in
the written description. See, e.g., W.L. Gore & Assoc., Inc. v.
Garlock, Inc., 721 F.2d 1540, 1556-58 ... (Fed. Cir. 1983)
4 Examiner's June 1, 2017 Answer.
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( claims not indefinite because the evidence showed that those
skilled in the art understood their scope even though the written
description failed to disclose precise definitions of certain terms
of art).
Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1385 (Fed.
Cir. 1999).
For the foregoing reasons we find that Examiner failed to establish an
evidentiary basis on this record to support a finding that the phrase "skin
active agent that modifies skin pigmentation" is indefinite.
CONCLUSION
The preponderance of evidence fails to support Examiner's conclusion
that the phrase "skin active agent that modifies skin pigmentation," as set
forth in Appellant's claims, is indefinite. The rejection of claims 1, 3, 6, 9--
11, and 15-20 under 35 U.S.C. § 112(b) is reversed.
Written Description:
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 Appellant's Specification fails to demonstrate that
Appellant "was in possession of the full scope of genes and related gene
expression signatures, skin active agents, and connectivity scores capable of
achieving the intended result" (Final Act. 7). In addition, Examiner finds
that Appellant's Specification fails to exemplify "the full scope of genes,
gene expression signatures, skin active agents, and connectivity scores being
claimed with no more than routine experimentation" (id.). In this regard,
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Examiner finds that Appellant's Specification "does not indicate which
specific gene expression signatures correlate with different skin
pigmentation conditions" or the "requisite parameters, computer programs,
and/or algorithms needed to make/use a mathematical model capable of
predicting these signature changes and predicting a treatment," because
"probabilisitic models for achieving the claimed results require well-defined
variables (structure) in order to correlate data with a particular disease
(function) (id. at 7-8; see also Ans. 8-12). We are not persuaded.
The method of Appellant's claim 1 requires, inter alia, the generation
of a gene expression profile for a human cell exposed to at least one
perturbagen, which comprises a skin active agent that modifies skin
pigmentation, identifying genes that are differentially expressed in response
to that at least one perturbagen by comparing the gene expression profiles of
cells exposed to perturbagen to control cells, creating an ordered list
comprising identifiers representing the differentially expressed genes,
storing the ordered list as an instance on a non-transitory computer readable
medium, and constructing a database of stored instances by repeating the
method steps for between about 50 and about 50,000 instances (see App. Br.
15). Appellant's claim 10 is drawn to a method of implementing the
database of claim 1 to identify at least one putative skin active agent for
treating a skin hyperpigmentation condition (see id. at 16-17).
"[T]he test for sufficiency [ of written description] is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010). As Appellant explains, Appellant's Specification provides
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a disclosure of the steps necessary to implement and/or practice Appellant's
claimed methods (see App Br. 11-13). In addition, Appellant directs
attention to prior art that supports Appellant's assertion that those of
ordinary skill in this art would understand, based on Appellant's disclosure,
how to implement and/or practice Appellants' claimed methods (id).
Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1534 (Fed. Cir.
1987) ("[a] patent need not teach, and preferably omits, what is well known
in the art.").
In sum, we find that Examiner failed to establish an evidentiary basis
on this record to support a finding that Appellant's Specification fails to
provide adequate written descriptive support for Appellant's claimed
invention.
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's finding that Appellant's Specification fails to provide written
descriptive support for the claimed invention. The rejection of claims 1, 3,
6, 9-11, and 15-20 under the written description provision of 35 U.S.C.
§ 112(a) is reversed.
Subject Matter Eligibility:
ISSUE
Does the evidence of record support Examiner's finding that
Appellants' claimed invention is directed to patent ineligible subject matter?
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ANALYSIS
The scope of 35 U.S.C. § 101 "is subject to an implicit exception for
'laws of nature, natural phenomena, and abstract ideas,' which are not
patentable." Intellectual Ventures I LLC, v. Capital One Fin. Corp.,
850 F.3d 1332, 1338 (Fed. Cir. 2017) (citing Alice Corp. Pty. Ltd. v. CLS
Bankint'l, 134 S. Ct. 2347, 2355 (2014)).
To determine whether the exception applies ... a court must
determine: (1) whether the claim is directed to a patent-
ineligible concept, i.e., a law of nature, a natural phenomenon,
or an abstract idea [(the "abstract idea" step)]; and if so, (2)
whether the elements of the claim, considered "both
individually and 'as an ordered combination,"' add enough to
"'transform the nature of the claim' into a patent-eligible
application [(the 'inventive concept' step)]."
Intellectual Ventures, 850 F.3d at 1338 (quoting Alice Corp., 134 S.
Ct. at 2355).
On this record, Examiner finds that Appellant's claim 1 is directed to
the abstract idea of "identifying data, creating a list, storing the list, and
constructing a data architecture" (Final Act. 2). Similarly, Examiner finds
that Appellant's independent claim 10 is directed to the abstract idea of
"querying the data structure[] and identifying a perturbagen (based on
connectivity scores)" (id. at 3). We find no error in Examiner's application
of the "abstract idea" step. Intellectual Ventures, 850 F.3d at 1338.
"[ A ]11 inventions at some level[, however,] embody, use, reflect, rest
upon, or apply laws of nature, natural phenomena, or abstract ideas" and "a
process is not unpatentable simply because it contains a law of nature or a
mathematical algorithm." Mayo Collaborative Servs. v. Prometheus Labs,
Inc., 566 U.S. 66, 71 (2012) (quoting Diamond v. Diehr, 450 U.S. 175, 187
(1981)). Thus, we consider Examiner's application of the 'inventive
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concept" step. Intellectual Ventures, 850 F.3d at 1338. Here, Examiner
finds that "[t]he additional step(s) directed to providing and generating gene
expression profiles (i.e. data) amount to nothing more than routine data
collection and/or insignificant extra-solution activity. For example, these
steps are generally recited to include routine and conventional gene
expression technologies (as admitted in [Appellant's] own disclosure on
page 22)" (Final Act. 3). We are not persuaded by Examiner's finding that
Appellants' disclosure admits that the specific steps set forth in Appellant's
claims are routine and conventional gene expression technologies when
considered both individually and as an ordered combination.
The portion of Appellant's Specification relied upon by Examiner
discloses:
As used herein, the terms "gene expression profiling" and
"gene expression profiling experiment" refer to the
measurement of the expression of multiple genes in a biological
sample using any suitable profiling technology. For example,
the mRNA expression of thousands of genes may be
determined using microarray techniques. Other emerging
technologies that may be used include RNA-Seq or whole
transcriptome sequencing using N extGen sequencing
techniques.
(Spec. 22: 18-22.) We are not persuaded by Examiner's assertion that this is
a disclosure of "generating a gene expression profile for a human cell
exposed to at least one perturbagen, wherein the perturbagen comprises a
skin active agent that modifies skin pigmentation" or the identification of
"genes differentially expressed in response to the at least one perturbagen by
comparing the gene expression profiles" of cells exposed to a perturbagen to
controls, or a method of implementing a database obtained from such gene
expression profiles as required by Appellant's claimed invention (see App.
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Br. 15-17). To the contrary, the definitions of "gene expression profiling"
and "gene expression profiling experiment" set forth in Appellant's
Specification and relied upon by Examiner do not to address gene expression
profiling in the context of a skin active agent that modifies skin
pigmentation as required by Appellant's claimed invention (see Spec.
22:18-22; cf App. Br. 15-17). Thus, notwithstanding Examiner's assertion
to the contrary, it cannot be said on the record before us that the specific
gene expression steps required by Appellant's claimed invention were well-
known, routine, and conventional in this art at the time of Appellant's
claimed invention.
Whether something is well-understood, routine, and con-
ventional to a skilled artisan at the time of the patent is a factual
determination. Whether a particular technology is well-
understood, routine, and conventional goes beyond what was
simply known in the prior art. The mere fact that something is
disclosed in a piece of prior art, for example, does not mean it
was well-understood, routine, and conventional.
Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018). On this
record, Appellant discloses that "[ t ]hrough careful selection of cell type, and
by generation of a reference collection of gene-expression profiles for
known skin-active agents and recognized skin disorders, the present
inventor[] [was] surprisingly able to create connectivity map architecture
useful for testing and generating hypotheses about skin-active agents and
hyperpigmentation skin disorders" (Spec. 7: 17-19).
Thus, although methods of obtaining gene expression profiles may
have been known in this art at the time of Appellant's claimed invention,
Examiner failed to establish an evidentiary basis on this record to support a
finding that gene expression profiling was well-known, conventional, and
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routine in the context of a skin active agent that modifies skin pigmentation
(see generally App. Br. 4 ("Step (b) of pending Claim 1 requires generating
a gene expression profile for a human cell exposed to at least one
perturbagen, wherein the perturbagen comprises a skin active agent that
modifies skin pigmentation, and wherein the cell is from the same cell line
as the control cell"); id. at 7 ("Claim 10 recites assigning a connectivity
score and identifying the type of putative skin active agent based on the
positivity or negativity of the connectivity score, which involves even more
specificity and complexity than pending Claim 1 "); see generally Reply Br.
4--7).
CONCLUSION
The evidence of record fails to support Examiner's finding that
Appellant's claimed invention is directed to patent ineligible subject matter.
The rejection of claims 1, 3, 6, 9--11, and 15-20 under 35 U.S.C. § 101 is
reversed.
REVERSED
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