Ex Parte BINDER et al

Patent Trials and Appeals Board

Jun 10, 2019

14749779 - (D) (P.T.A.B. Jun. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/749,779 06/25/2015
27752 7590 06/12/2019
THE PROCTER & GAMBLE COMPANY
Global IP Services
Central Building, C9
One Procter and Gamble Plaza
CINCINNATI, OH 45202
FIRST NAMED INVENTOR
Robert Lloyd BINDER
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.
12002MD2 3870
EXAMINER
AULT, ADDISON D
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
06/12/2019 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 ROBERT LLOYD BINDER, ROBERT SCOTT YOUNGQUIST,
JUN XU, KENTON DUANE JUHLIN, ROSEMARIE OSBORNE, and
SCOTT MICHAEL HARTMAN
Appeal2017-008235
Application 14/749,779
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from Examiner's
decision to reject claims as being indefinite, lacking written descriptive
support, and for being directed to non-statutory subject matter. We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
1 The Appeal Brief ("Br.") lists The Procter & Gamble Company of
Cincinnati, Ohio, the assignee of record, as the real party in interest. Br. 1.
We have considered, and herein refer to, the Specification of June 25, 2015
("Spec."); Final Office Action of Aug. 26, 2016 ("Final Act."); Appeal Brief
of Jan. 30, 2017 ("Appeal Br."); Examiner's Answer of Mar. 17, 2017
("Ans."); and Reply Brief of May 11, 2017 ("Reply Br.").
Appeal2017-008235
Application 14/749,779
STATEMENT OF THE CASE
Claims 1 and 7-18 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1. A method of making a skin care composition,
compnsmg:
(a) accessing a computer readable medium having stored
thereon a plurality of instances and at least one skin aging gene
expression signature, wherein each instance is associated with a
cosmetic agent and wherein each instance comprises an ordered
list of identifiers representing a plurality of up-regulated and a
plurality of down regulated genes differentially expressed in
response to contact between the cosmetic agent and a human
dermal fibroblast cell or a human keratinocyte cell, the skin aging
gene expression signature comprises one or more lists
comprising a plurality of identifiers representing a plurality of
up-regulated genes and a plurality of down-regulated genes
associated with a skin aging condition, and from about 80% to
about 100% of the plurality of identifiers associated with the skin
aging gene expression signature represent a gene set forth in any
of Tables A to D;
(b) comparing the skin aging gene expression signature to
each of the instances, wherein the comparison comprises
comparing each identifier in the gene expression signature list( s)
with the position of the same identifier in the ordered lists for
each of the instances;
( c) assigning a connectivity score to each instance based
on the comparison in (b );
( d) generating a list of cosmetic agents associated with
each instance that has a negative connectivity score; and
( e) incorporating at least one of the cosmetic agents from
the list in ( d) into a skin care composition; and
wherein at least one of steps (a), (b ), ( c) and ( d) are
performed by a programmable computing device comprising
computer-readable instructions for executing the at least one
step.
Appeal Br. 14--15 (Claims Appendix).
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Application 14/749,779
Appellant requests review of following rejections made by Examiner:
I. Claims 1 and 7-18 under 35 U.S.C. § 112, second paragraph as
being unclear what the standard is to calculate the connectivity score.
II. Claims 1 and 7-18 under 35 U.S.C. § 112, first paragraph as
failing to sufficiently describe the structure/function relationship to
encompass the genus of cosmetic agents now claimed.
III. Claims 1 and 7-18 under 35 U.S.C. § 101, as being directed to
an abstract idea.
I. Indefiniteness
Examiner found that the term "negative connectivity score" as recited
in claim 1 step ( d) is indefinite because "[i]t is unclear what standard of
reference is contemplated for evaluating whether connectivity score has a
'negative correlation.'" Ans. 2. Specifically, Examiner explains "that
because none of [steps] (a)-( c) of claim 1 clearly define what is used as a
standard of comparison, the steps to be carried out in ( d) and ( e) are
unclear." Id. at 8. Examiner further explains that "the claim fails to set forth
specific method steps that would allow a 'connectivity score' to be
calculated as set forth in the specification, and thus an artisan would not
know how to practice the method as claimed." Id. at 9.
Appellant contends that the claim does not recite "negative
correlation" and that the Specification "discloses that negative connectivity
occurs when the up-regulated genes of a gene expression signature are
predominately found among the down-regulated genes of an instance, and
vice-versa." Appeal. Br. 3 (citing Spec. 34:29-35:17, Fig. 6, and Fig. 7), see
Reply Br. 1-2.
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Application 14/749,779
We are not persuaded by Examiner's contention that an artisan would
not know how to practice the invention as claimed. We agree with
Appellant that the Specification provides sufficient guidance on how to
determine a connectivity score for a particular gene and to be able to
determine if the gene shows a negative connectivity when compared to a
gene expression signature. A "connectivity score" as recited in the
Specification "refers to a derived value representing the degree to which
an instance2 correlates to a query." Spec. 19:14--15. Example 1 of the
Specification, explains how each gene expression profile for each instance is
generated. See Spec. 43--44. Tables A-D disclose skin aging gene
expression signatures. See Spec. 44--49. To obtain the connectivity score
requires comparing each identifier result of an instance with the results of
the same identifier in one of the skin aging gene expression signatures set
out in Tables A-D. See Spec. 50-64, Fig. 6-8. The Specification explains
that those instances that have a negative connectivity score "are predicted to
have [a] beneficial effect" because they are counter acting the activity
associated with photo-aging or intrinsic aging. See Spec. 51: 1-3, 65, Fig. 6-
8. "Since both intrinsic aging and photo-aging are considered adverse
conditions, it is preferential to find materials that tend to reverse one or both
of the gene expression signatures. Such materials will have negative
connectivity score, and the more negative the score the stronger the negative
connection." Spec. 65:4--7.
2 The Specification defines an instance: as data from a gene expression
profiling experiment in which skin cells are exposed to a perturbagen.
Spec. 16:22-23.
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Appeal2017-008235
Application 14/749,779
Claim 1 (b) instructs to compare the skin aging gene expression
signature identifier as set out in Tables A-D of the Specification to each the
identifiers listed for each instance. The result of the comparison in step (b)
leads to the assignment of a connectivity score set out in step ( c ). The
Specification explains that it is "preferential to find materials that tend to
reverse one or both of the gene expression signatures. Such materials will
have negative connectivity score, and the more negative the score the
stronger the negative connection." Spec. 65:5-7. Figure 7, reproduced
below, shows an example of extreme negative connectivity.
9l
1
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., ·: .. ·'., ... ~., ..... :
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.•,i f'!(J, 7
FIG. 7[, reproduced above,] schematically illustrates an extreme
example of a negative connectivity between signature 94 and the
instance 88 comprising the probe IDs 90, wherein the probe IDs
of the instance are ordered from most up-regulated to most down-
regulated. In this example, the probe IDs of the up list 93 ( e.g.,
X1, X2, X3, X4) correspond exactly with the most down-regulated
genes of the instance 88, and the probe IDs of the down list 95
( e.g.,Xs, X6, X7, Xs) correspond exactly to the most up-regulated
probe IDs of the instance 88.
Spec. 35:14--21. When "the up-regulated genes of the signature are
predominantly found among the down-regulated genes of the instance, and
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Appeal2017-008235
Application 14/749,779
vice versa, this is scored as negative connectivity." Spec. 35:6-8. Based on
these disclosures in the Specification, we agree with Appellant that the term
negative connectivity score as claimed is sufficiently described.
The preponderance of the evidence of record does not support
Examiner's conclusion that step ( d) of claim 1 is indefinite. Accordingly,
we reverse the rejection of claim 1 and any of its dependents.
II. Written Description
Examiner found that the Specification does not provide adequate
written descriptive support for the "claimed genus, the specification must
provide sufficient distinguishing identifying characteristics of the genus."
Ans. 4. Examiner acknowledges that the Specification "describes tests of
carob seed extract and artichoke leaf extract. 3 [But maintains that n Jo
description is provided of a genus of cosmetic agents having a connectivity
score with a negative correlation." Id. Examiner's position is "[i]f the
cosmetic agents of the claims are not already known in the literature, then it
is Appellant's responsibility to disclose them in the specification." Id. at 10.
"Adequate written description requires more than a mere statement that it is
part of the invention and reference to a potential method of isolating it. The
compound itself is required." Ans. 6 ( citing Fiers v. Revel, 25 USPQ2d
3 The Specification disclosed that both artichoke leaf extract and carob seed
extract linked negatively to photo-aging gene expression. See Spec. 64--7 4
(Examples 6 and 7). Although the description of two agents is not a great
number, it is also not zero. Additionally, we note that the two cosmetic
agents were obtained using the imbedded screening method set out in steps
(a}-( c) of claim 1.
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Application 14/749,779
1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co.
Ltd., ... [927 F.2d 1200 (Fed. Cir. 1991))]."
Appellant takes the position that there is a strong presumption that
adequate written description is found in an application as filed. Appeal Br.
3--4. Specifically, Appellant contends that "claim 1 does not attempt to
claim a particular genus of cosmetic agents per se." Id. at 4. The
Specification additionally "indicates that a negative connectivity score
occurs when the up-regulated genes of the signature are predominantly
found among the down-regulated genes of the instance." Reply Br. 3.
Appellant contends that the "techniques for creating instances and
identifying/screening cosmetic agents associated with those instances are
clearly described in the specification." Id. Appellant contends that "[i]n
contrast with Fiers, pending claim 1 recites a specific method of identifying
a cosmetic agent, and the present application provides numerous specific
examples of cosmetic agents. Thus, Fiers is not applicable to the facts of the
present case." Id. Additionally, Appellant notes that Amgen is not relevant
to the facts in this case. Id. at 4.
On this record, we find that Appellant has the better position. Claim 1
is directed to a method of making a cosmetic skin care composition by
incorporating cosmetic agents. See claim 1 (preamble and step ( e) ). The
written description requirement "serves a teaching function, as a 'quid pro
quo' in which the public is given 'meaningful disclosure in exchange for
being excluded from practicing the invention for a limited period of time."'
Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir.
2004).
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Appeal2017-008235
Application 14/749,779
We find that the Specification describes at least two compositions,
artichoke leaf extract and carob seed extract, that possess the requisite
negative connectivity score for incorporation into the cosmetic composition.
See Spec. 64--74 (Examples 6 and 7). Additionally, the activity of these two
compounds was determined using the screening method set out in steps (a}-
( c) of the claim 1. See Spec. 65 ("Of the 20 candidates screened, 2 showed
consistent connections to the photo-aging gene expression signatures when
tested in BJ fibroblasts" (Human skin fibroblasts (BJ cell line from ATCC,
Manassas, VA))). Thus, the disclosure in the Specification establishes that
the screening method is not just hypothetical but is actually proven to work
and thereby satisfies the basic quid pro quo underlying the patent system.
See Rochester, 358 F.3d at 929.
Examiner's rejection, however, focuses on the list of cosmetic agents
having a negative connectivity score as recited in step ( d) of claim 1. See
Final Act. 10 ("A computational method of screening for agents may not
suffer the same deficiencies, but the claims make clear that the method is a
method of making a skin care product. Thus written description of the
agents to be incorporated in the skin care product is required"). By focusing
on the list, Examiner ignores the additional claim elements found in steps
(a}-( c) of the claim that incorporates the screening method. As discussed
above, the Specification establishes that the disclosed screening method
successfully identified known cosmetic compounds that have a requisite
negative connectivity score. In other words, the Specification provides
sufficient guidance that would steer the skilled practitioner toward
compounds useful for successfully carrying out the claimed method of
producing a skin care composition.
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Application 14/749,779
On this record, the preponderance of the evidence of record does not
support Examiner's conclusion that Specification lacks sufficient written
descriptive support for the method recited in claim 1. Accordingly, we
reverse the rejection of claim 1 and any of its dependents.
III. Abstract Idea
Examiner's position is that "[t]he idea of using gene expression
patterns to identify agents is an abstract idea and thus the claims must be
analyzed for subject matter eligibility under USC 101." Ans. 6. In
particular, "Examiner's position is that the specific steps implemented on the
computer and the algorithm/workflow used to identify cosmetic agents are
abstract ideas that have been implemented on a computer." Ans. 11. 4
Appellant contends that Examiner's 35 U.S.C. § 101 analysis is over-
simplified. Appeal Br. 7. Appellant contends that Examiner (1) did not
identify a judicial exception, (2) did not identify the additional elements, and
(3) did not consider the combination as a whole. See id. at 6. Specifically,
Appellant contends that "the limitation of accessing the database in step (a)
and the physical step of incorporating the cosmetic agent into a skin care
composition in step ( e) [ of claim 1]. Both of these steps require some form
of action that cannot be performed in the human mind." Id. at 8.
4 Examiner's rejection under 35 U.S.C. § 101, is based on the claims being
directed to an abstract idea. See Ans. 6-7, 12. Examiner acknowledges that
the use of skin care agents that prevent aging touches a "law of nature" (see
id. at 7) but ultimately concludes that "[t]he claims, in their current form,
lack any data, correlations or facts that could be construed as laws of
nature . . . because the 'judicial exception' in the claims is an abstract idea,
not a law of nature" (id. at 12).
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Appeal2017-008235
Application 14/749,779
We analyze this appeal under the framework set forth by the Supreme
Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566
U.S. 66 (2012), and applied by our reviewing court in Ariosa Diagnostics,
Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). As theAriosa court
explained:
In Mayo ... , the Supreme Court set forth a framework for
distinguishing patents that claim laws of nature, natural
phenomena, and abstract ideas from those that claim patent-
eligible applications of those concepts. First, we determine
whether the claims at issue are directed to a patent-ineligible
concept. If the answer is yes, then we next 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 the second step 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."
Id. at 1375 (alteration in original) (internal citations omitted).
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 test (i.e., Step 2A of the Revised Guidance) is "a two-
prong inquiry." Id. at 54. In prong one, we evaluate whether the claim
recites a judicial exception, such as a law of nature, natural phenomenon, or
an abstract idea. Id. If the claim recites a judicial exception, the claim is
further analyzed under prong two, which requires "evaluat[ion ofJ whether
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Application 14/749,779
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]." Id.
Step 2A - Prong One
In our analysis, we must determine whether Appellant's claims are
directed to a judicial exception. We select claim 1 as representative.
Concepts determined to be abstract ideas, and thus patent ineligible judicial
exceptions, 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); Diamond v. Diehr, 450 U.S. 175, 191 (1981)); and mental processes
( Gottschalk v. Benson, 409 U.S. 63, 69 (1972)). With respect to the first
prong of Step 2A of the Revised Guidance, we do not agree with Examiner
that independent claim 1 recites a patent-ineligible abstract idea.
Appellant's claim 1 is not directed to a method of organizing human
activity, nor has Examiner established that the accessing, comparing, and
assigning steps of Appellant's claimed method could practicably be
performed in the human mind, and, therefore, amount to a mental process.
See Appeal Br. 8 ("the limitation of accessing the database in step (a) and
the physical step of incorporating the cosmetic agent into a skin care
composition in step ( e ). Both of these steps require some form of action that
cannot be performed in the human mind"). The final category of abstract
ideas identified by the courts is mathematical concepts. See 84 Fed. Reg. at
52. Appellant's claim 1 does not recite a mathematical concept, such as a
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Application 14/749,779
specific mathematical algorithm or formula. See Parker, 437 U.S. at 586;
Diehr, 450 U.S. at 187. Although Appellant's claim 1 may recite steps that
tangentially involve mathematics ( e.g. comparing two lists by use of a
computer), claim 1 does not recite a specific mathematical concept such as
an algorithm or formula. Appellant's 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 and 7-18 are not directed to a judicial exception.");
see also Reply Br. 5). Because we find that claim 1 does not recite a judicial
exception, our analysis of the 35 U.S.C. § 101 rejection could end here. For
the reasons discussed below, we additionally determine that prong two of
step 2A of the Revised Guidance is also not met.
Step 2A - Prong Two
Even if we were to interpret Appellant's claim 1 to recite a patent-
ineligible mathematical concept, under the Revised Guidance, we would
then also determine "whether the claim recites additional elements that
integrate the exception into a practical application of that exception." 84
Fed. Reg. at 54. Limitations that are indicative of integration into a practical
application include applying the natural law to effect a particular treatment
or prophylaxis for a disease or medical condition. See, e.g., Classen
Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68 (Fed. Cir.
2011); see Vanda Pharms. Inc. v. West-Ward Pharms. Int'! Ltd., 887 F.3d
1117, 1134--35 (Fed. Cir. 2018).
Here, claim 1 is directed to making a skin care composition by
incorporating cosmetic agents that have a negative connectivity score and
thereby incorporates beneficial substances that counter act the effects of
photo-aging or intrinsic aging into a practical formulation for application to
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the skin. See Spec. 51: 1-3, see also id. at 65:3-7 ("Since both intrinsic
aging and photo-aging are considered adverse conditions, it is preferential to
find materials that tend to reverse one or both of the gene expression
signatures."). We agree with Appellant's and conclude that the physical step
of incorporating the cosmetic agent identified in steps (a}-( d) of claim 1 into
a skin care composition as set out in step ( e) is a practical application of the
knowledge gathered in these prior steps and thereby transforms the gathering
information into a practical use. See Classen, 659 F.3d at 1067-1068.
For the reasons discussed above, we are not persuaded that Examiner
has established by a preponderance of the evidence of record that claim 1 is
patent ineligible. Accordingly, we reverse the rejection of claim 1 and any
of its dependents.
SUMMARY
We reverse the rejection of all claims.
REVERSED
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