Makio Tamura et al.

Patent Trials and Appeals Board

Dec 26, 2019

14851418 - (D) (P.T.A.B. Dec. 26, 2019)

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.
14/851,418 09/11/2015 Makio TAMURA 13533 5825
27752 7590 12/26/2019
THE PROCTER & GAMBLE COMPANY
GLOBAL IP SERVICES
CENTRAL BUILDING, C9
ONE PROCTER AND GAMBLE PLAZA
CINCINNATI, OH 45202
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
12/26/2019 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
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 MAKIO TAMURA, ROSEMARIE OSBORNE, and
HEATHER LYNN ROCCHETTA
Appeal 2018-005659
Application 14/851,418
Technology Center 1600
Before RICHARD M. LEBOVITZ, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 30 and 33. See Final Act. 4. 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.
Appeal 2018-005659
Application 14/851,418

2
CLAIMED SUBJECT MATTER
The claims are directed to a method for identifying an agent effective
for transcriptionally up-regulating an eigengene associated with a desirable
cosmetic phenotype of human skin. Claim 30, reproduced below (with
spacing added for ease of reading), is illustrative of the claimed subject
matter:
30. A method for identifying an agent effective for
transcriptionally up-regulating an eigengene associated with a
desirable cosmetic phenotype of human skin, the method
comprising:
deriving an eigengene for a co-expression module
determined from a set of genes transcriptionally up-regulated in
human skin exhibiting the desirable cosmetic phenotype and a
set of genes associated with a clean and detox biological theme
selected from the group consisting of protein catabolic process,
regulation of autophagy, regulation of endopeptidase activity,
and regulation of proteolysis;
treating skin with a putative agent;
conducting a transcriptional assessment of the eigengene
in the treated skin; and
identifying the putative agent as an effective clean and
detox agent if the eigengene is up-regulated in the treated skin.
Appeal Br. 6 (Claims Appendix).
REFERENCE
The prior art relied upon by the Examiner is:
Name Reference Date
Giuliani US 2014/0163118 A1 June 12, 2014
REJECTIONS
Claims 30 and 33 stand finally rejected by the Examiner under 35
U.S.C. § 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C.
§ 103 as obvious over, Giuliani. Final Act. 4.
Appeal 2018-005659
Application 14/851,418

3
OPINION
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We determine that the
Examiner has not carried the burden of presenting a prima facie case of
unpatentability.
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). In relevant part, independent claim 30
recites “deriving an eigengene” from two sets of genes, one of which is “a
set of genes associated with a clean and detox biological theme selected
from the group consisting of protein catabolic process, regulation of
autophagy, regulation of endopeptidase activity, and regulation of
proteolysis.” Appeal Br. 6 (Claims Appendix). The Specification teaches
that
[u]nder the Eigengene model, a “module” is a group of
interconnected genes that forms a biological pathway, process or
theme, and an intersecting set of two or more modules is called
a “co-expression module.” A gene expression profile of a
module or co-expression module may be represented by an
“eigengene,” and eigengene networks may be constructed to
represent the relationships between and within genetic co-
expression modules. Derivation of an “eigengene” collapses
many data points into a single vector. An eigengene may be
thought of as a summary of a module expression profile into a
single representative gene. An eigengene reflects the variance
between the genes comprising the modules.
Spec. 3:23–30. The Examiner found that Giuliani teaches the “deriving an
eigengene” limitation via its disclosure of “gene expression signature of
Appeal 2018-005659
Application 14/851,418

4
genes and coordinately expressed gene networks associated with skin
aging.” Final Act. 4 (citing Giuliani Abstract).
Appellant acknowledges that Giuliani teaches connected networks of
genes involved in skin aging, but argues that Giuliani does not teach
“‘deriving an eigengene’ from the connected networks.” Appeal Br. 2–3.
Appellant argues that “[a]t most, the disclosure in Guiliani [sic] might be
construed as recognizing that co-expression modules exist. But Giuliani
does not teach summarizing co-expression modules profiles into a single
representative gene, i.e., an eigengene.” Id. at 3; see also Reply Br. 3
(arguing that in Giuliani, there is “no disclosure of summarizing such a
higher order organization of interconnected networks into a single vector”).
On this record, we determine that in general, Giuliani teaches
derivation of eigengenes. For example, Giuliani teaches that “skin aging
results from the dysregulation of key regulatory genes (i.e., gene
signatures) that control thousands of genes in multiple, interacting and
overlapping networks and pathways.” Giuliani ¶ 4 (emphasis added).
Giuliani also teaches a method that includes the steps of identifying genes,
networks, and pathways associated with skin aging, and identifying a “small
number of genes whose expression can serve as predictors (i.e.
biomarkers) of skin aging.” Giuliani ¶ 69 (emphasis added). Giuliani also
teaches that “[k]ey to this and future work is the identification of nodes
(genes) that connect networks together. It is the gene signatures in
different but connected and interacting networks that determine the aging
process.” Giuliani ¶ 66 (emphasis added). Based on the current record,
Giuliani’s “key regulatory genes (i.e., gene signatures)” and “small number
of genes whose expression can serve as predictors (i.e. biomarkers of skin
Appeal 2018-005659
Application 14/851,418

5
aging)” appear to be akin to Appellant’s eigengene, which, again, is
described in the Specification as “a summary of a module expression profile
into a single representative gene.” Spec. 3:28–29.
Nevertheless, we determine that the Examiner has not demonstrated a
prima facie case of anticipation. As noted above, independent claim 30
requires that the eigengene be derived from two specific sets of genes, one
of which is “a set of genes associated with a clean and detox biological
theme selected from the group consisting of protein catabolic process,
regulation of autophagy, regulation of endopeptidase activity, and regulation
of proteolysis.” The Examiner has not demonstrated that Giuliani teaches
any genes that fall within this recited set. As such, the Examiner has not
demonstrated that Giuliani teaches all of the limitations of claim 30. Claim
33 depends from claim 30, and thus also requires presence of this limitation
in the prior art to support a finding of anticipation.
The Examiner asserts that “deriving an eigengene . . . determined
from a set of genes” is “a mental step, wherein the user determines what
would be considered ‘clean and detox’ selected from ‘protein catabolic
process . . . ,” and that “[i]t does not matter if this deriving/determining
mental step of the user is proven wrong or right by other scientists.” Id.
Final Act. 5. We are not persuaded by the Examiner’s arguments.
First, we agree with Appellant that the Examiner has not “provided
any evidence or reasoning beyond the conclusory statement in the Final
Rejection to show that these limitations could be performed entirely in the
human mind.” Appeal Br. 3. Appellant points to Example 2 in the
Specification, where an eigengene was derived via “[s]ingular value
decomposition [] applied to the transcriptome profile” for co-expression
Appeal 2018-005659
Application 14/851,418

6
modules for a “‘younger-appearance’ gene set and each of several biological
process/theme modules.” Appeal Br. 3 (quoting Spec. 19:27–20:2). The
Examiner has not explained how such steps could be performed in the
human mind. More importantly, however, even if the step of deriving the
eigengene step could be performed in the mind, that does not excuse the
Examiner from having to demonstrate that Giuliani teaches “a set of genes
associated with a clean and detox biological theme” selected from the recited
group in order to support a finding of anticipation, and the claim still
requires “conducting a transcriptional assessment of the eigengene in the
treated skin.” See, e.g., Metabolite Labs Inc. v. Lab. Corp. of Am. Holdings,
370 F.3d 1354, 1367 (Fed. Cir. 2004) (prior art did not anticipate because it
failed to teach, among other limitations, the claimed “correlating” step).
With respect to the alternative obviousness rejection, the Examiner
addresses only claim 33, stating that this claim “appears to be repeating the
same active steps, but using different deriving/determined mental steps,” and
that “[i]t would have been obvious for one skilled in the art to repeat the
same active steps to determine other genes associated in the aging process
and determining where [sic] wrong or right what those genes might do in
skin aging.” Final Act. 5. This analysis is deficient for the same reason
discussed above, i.e., that the Examiner has not demonstrated that Giuliani
teaches deriving an eigengene in part from “a set of genes associated with a
clean and detox biological theme” selected from the recited group, as
required by independent claim 30.
The Examiner does not provide a reasoned explanation for the
obviousness rejection of claim 30. In an ex parte appeal, the Board “is
basically a board of review—we review final rejections made by patent
Appeal 2018-005659
Application 14/851,418

7
examiners. In order to have meaningful review, we must be able to
understand the examiner’s rejection . . . .” Ex parte Gambogi, 62 USPQ2d
1209, 1211–12 (BPAI 2001). Because the Examiner has not detailed any
differences between claim 30 and Giuliani, or any reasons why a person of
ordinary skill in the art would have concluded that the invention defined by
the limitations of claim 30 would have been an obvious variation of what is
disclosed in Giuliani, we are constrained to reverse the obviousness rejection
of claim 30.
For the reasons discussed above, we determine that the Examiner has
not established a prima facie case of unpatentability of claims 30 and 33
based on anticipation or obviousness over Giuliani.
CONCLUSION
We reverse the rejection of claims 30 and 33 under 35 U.S.C.
§ 102(a)(1) as anticipated by Giuliani.
We reverse the rejection of claims 30 and 33 under 35 U.S.C. § 103 as
obvious over Giuliani.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
30, 33 102(a)(1) Giuliani 30, 33
30, 33 103 Giuliani 30, 33
Overall
Outcome:
  30, 33
REVERSED