Ex Parte HAKOZAKI et al

Patent Trial and Appeal Board

Feb 13, 2019

13851864 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/851,864 03/27/2013
27752 7590 02/15/2019
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.
12359M2 4323
EXAMINER
WHALEY, PABLO S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
02/15/2019 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 TOMOHIRO HAKOZAKI, WENZHU ZHAO,
ROBERT LLOYD BINDER, and JUN XU
(APPLICANT: THE PROCTER & GAMBLE COMP ANY)
Appeal2018-003293
Application 13/851,864 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 1-8 and 13-19
(Final Act. 2 1 ). 3 Examiner entered rejections under 35 U.S.C. § 112, second
paragraph, 35 U.S.C. § 101, and obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify "The Procter & Gamble Company" as the real party in
interest (Appellants' May 8, 2017 Appeal Brief ("App. Br.") 1).
2 Examiner's December 7, 2016 Final Office Action.
3 Pending claims 9-12 and 20 stand withdrawn from consideration (Final
Act. 1).
Appeal2018-003293
Application 13/851,864
STATEMENT OF THE CASE
Appellants' 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). Appellants'
claims 1 and 2 are representative and reproduced below:
1. A method of formulating a skin-lightening composition,
compnsmg:
(a) constructing a database for use in identifying connections
between perturbagens and genes associated with skin tone,
compnsmg
i. 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,
11. generating a gene expression profile for a human cell
exposed to a perturbagen, wherein the cell is from the
same cell line as the control cell,
111. identifying genes differentially expressed in response
to the perturbagen by comparing the gene expression
profiles of (a)(i) and (a)(ii),
1v. creating an ordered list comprising identifiers
representing the differentially expressed genes,
wherein the identifiers are ordered according to the
differential expression of the genes,
v. 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)(i), and
v1. constructing a database of stored instances by
repeating (a)(i) through (a)(v), wherein the at least one
perturbagen of step (a)(ii) is different qualitatively or
quantitatively for each instance;
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Application 13/851,864
(b) querying the database to identify at least one putative skin
active agent; and
( c) confirming that the putative skin active agent provides skin-
pigmentation modifying efficacy using in vitro assays or
clinical methods; and
( d) mixing the putative skin active agent with a
dermatologically acceptable carrier to provide a skin-
lightening composition.
(Claims Appendix4 3--4.)
2. The method of claim 1, wherein querying the data
architecture comprises
(a) querying the database with a gene expression signature, and
comparing the gene expression signature to each stored cell
instance,
(b) the gene expression signature represents genes differentially
expressed in skin affected with a skin hyperpigmentation
condition as compared to non-hyperpigmented skin, or
genes differentially expressed in cells treated with a
benchmark skin active agent having known efficacy in
treating a skin hyperpigmentation condition as compared to
a control, and
( c) the gene expression signature is derived from a cell line cell
corresponding to the cell line from which the instances are
derived.
(Id. at 4.)
Grounds of rejection before this Panel for review:
Claims 1-8 and 13-19 stand provisionally rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims of co-pending Application 13/851,858.
Claim 2 stands rejected under 35 U.S.C. § 112, second paragraph.
Claims 1-8 and 13-19 stand rejected under 35 U.S.C. § 101.
4 Appellants' August 8, 2017 Corrected Appeal Brief.
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Application 13/851,864
Obviousness-type Double Patenting:
ISSUE
Should the obviousness-type double patenting rejection on this record
be summarily affirmed?
ANALYSIS
Examiner provisionally rejected Appellants' claims 1-8 and 13-19
"on the ground of nonstatutory obviousness-type double patenting as being
unpatentable over [claims] ... of [co-pending] Application No. 13/851858"
(Final Act. 13).
Appellants do not contest this provisional rejection, arguing instead
that because the co-pending Application has not issued as a Patent, "the
provisional rejection is not ripe for appeal" (App. Br. 13). If a ground of
rejection stated by Examiner is not addressed in the Appellants' Brief,
Appellants waived any challenge to that ground of rejection and that ground
of rejection will be summarily sustained by the Board. See Manual of Patent
Examining Procedure ("MPEP") § 1205.02. Therefore, we summarily
affirm the provisional nonstatutory obviousness-type double patenting
rejection on this record.
CONCLUSION
The obviousness-type double patenting rejection on this record be
summarily affirmed. The provisional rejection of claim 1 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims of co-pending Application No. 13/851,858 is
summarily affirmed. Claims 2-8 and 13-19 are not separately argued and
fall with claim 1.
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Definiteness:
ISSUE
Does the preponderance of evidence support Examiner's conclusion
that the phrase "'pigment-relevant gene expression signature,'" as set forth
in Appellants' claim 2, is indefinite?
ANALYSIS
According to Examiner, Appellants' claim 2 is indefinite in the
recitation of the phrase "'pigment-relevant gene expression signature"' (see
Final Act. 12-13; see also Ans. 10). Notwithstanding Examiner's assertion
to the contrary, the phrase "pigment-relevant gene expression signature"
does not appear in Appellants' claim 2 (see Claims Appendix 4). Thus,
Examiner failed to establish that Appellants' claim 2 is indefinite.
CONCLUSION
The preponderance of evidence fails to support Examiner's conclusion
that the phrase "pigment-relevant gene expression signature," as set forth in
Appellants' claim 2, is indefinite. The rejection of claim 2 under 35 U.S.C.
§ 112, second paragraph is reversed.
Subject Matter Eligibility:
ISSUE
Does the preponderance of evidence of record support Examiner's
finding that Appellants' claimed invention is directed to patent ineligible
subject matter?
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PRINCIPLES OF LAW
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 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. Pty. Ltd. 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 Supreme Court's two-step 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. Kappas, 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);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and
mental processes ( Gottschalk v. Benson, 409 U.S. 63, 69 (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 183 n.7 (quoting Corning v. Burden, 56 U.S.
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252, 267---68 (1854))); and manufacturing flour (Gottschalk, 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
Supreme 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 176; 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 Supreme 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. (citing Gottschalk and Parker); 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 tum 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 ( quotation marks 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. (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.
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The PTO recently published revised guidance on the application of
§ 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50 (January 7, 2019) ("Memorandum"). Under that guidance,
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 interactions such as a fundamental economic
practice, or mental processes); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP § 2106.05(a}-(c), (e}-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
are 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.
See Memorandum.
ANALYSIS
Examiner rejects all pending claims as directed to ineligible subject
matter under 35 U.S.C § 101 (see Final Act. 2-6). According to Examiner,
the steps of Appellants' claim 1, 5 relating to "constructing a data architecture
(step a, parts i-vi); querying the database (step b ); and confirming that the
putative skin agent provides ... modifying efficacy using in vitro assays or
clinical methods (step c )" are abstract ideas and the phrase "'clinical
methods' broadly encompass computational algorithms used by a physician
5 Appellants' claims 2-8 and 13-19 depend directly or indirectly from
Appellants' claim 1.
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in the clinic" (Final Act 2-3 ( emphasis omitted; alteration original); see also
Ans. 4, 5---6). We are not persuaded.
Appellants' claim 1 is not directed to a method of organizing human
interactions, nor has Examiner established that the constructing, querying,
and confirming steps of Appellants' claimed method could practicably be
performed in the human mind, and, therefore, amount to a mental process.
The final category of abstract ideas identified by the courts is mathematical
concepts. See Memorandum. Appellants' claim 1, however, does not recite
a mathematical concept, such as a specific mathematical algorithm or
formula (see Parker, 437 U.S. at 586; Diehr, 450 U.S. at 187). Although
Appellants' claim 1 may recite steps that involve mathematics, claim 1 does
not recite a specific mathematical concept such as an algorithm or formula.
Appellants' claim 1, therefore, does not recite an abstract idea that would
make it patent-ineligible under 35 U.S.C. § 101 (see App. Br. 7 ("[C]laim 1
is not directed to a judicial exception."); see also Reply Br. 11-12).
In addition, even if we interpret Appellants' claim 1 to recite a
mathematical concept and, therefore, an abstract idea, it integrates any
recited mathematical concept into a practical application. Specifically, a
method of formulating a skin-lightening composition, wherein the method
comprises the steps of, inter alia, ( c) confirming that a putative skin active
agent provides skin-pigmentation modifying efficacy using in vitro assays or
clinical methods and ( d) mixing a putative skin active agent with a
dermatologically acceptable carrier to provide a skin-lightening composition
(see Claims Appendix 3--4; cf Ans. 5 (Appellants' claims "do not include
additional steps/ elements appended to the judicial exception that are
sufficient to amount to significantly more than the judicial exception(s).")).
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Thus, Appellants' claim 1 is a chemical process and is, therefore, a patent
eligible process. See Diehr, 450 U.S. at 192.
In this regard, we are not persuaded by Examiner's unsupported
assertion that the mixing of two reagents to form a skin-lightening
composition is nothing more than the application of an abstract idea (see id.
(the mixing step of Appellants' claimed invention "amounts to nothing more
than merely applying or using the judicial exception(s)") (Final Act. 3).
We are also not persuaded by Examiner's unsupported assertions that the use
of clinical methods to confirm whether a putative skin active agent provides
skin-pigmentation modifying efficacy "broadly encompass computational
algorithms used by a physician in the clinic" or, in the alternative, are
"nothing more than well-understood, routine, and conventional activities
previously known to the industry, e.g. spectrophotometry" (Final Act. 3--4;
see also Ans. 7-8; cf Reply Br. 10).
Whether something is well-understood, routine, and
conventional 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).
CONCLUSION
The preponderance of evidence of record fails to support Examiner's
finding that Appellants' claimed invention is directed to patent ineligible
subject matter. The rejection of claims 1-8 and 13-19 under 35 U.S.C.
§ 101 is reversed.
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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
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