NESTEC S.A.

Patent Trials and Appeals Board

May 21, 2021

2020005090 (P.T.A.B. May. 21, 2021)

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.
15/050,343 02/22/2016 SHARAT SINGH 088473-1002391-026710US 8975
20350 7590 05/21/2021
Kilpatrick Townsend & Stockton LLP - West Coast
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
HALVORSON, MARK
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
05/21/2021 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):
KTSDocketing2@kilpatrick.foundationip.com
ipefiling@kilpatricktownsend.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SHARAT SINGH, NICHOLAS HOE, and KELLY D. HESTER
____________

Appeal 2020-005090
Application 15/050,343
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 3, 6–18, and 23–28 (Br. 5).2 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 “Société des
Produits Nestlé S.A.” (Appellant’s February 28, 220, Appeal Brief (Br.) 3).
2 Appellant’s pending claim 4 stands withdrawn from consideration (see Br.
5).
Appeal 2020-005090
Application 15/050,343

2
STATEMENT OF THE CASE
Appellant’s disclosure “provides assays and methods for determining
an individual’s risk of developing colorectal cancer (CRC) by analyzing a
pre-cancerous polyp tissue sample” and “assay[s] and methods for selecting
an anticancer therapeutic drug for an individual diagnosed as having early
stage CRC” (Spec.3 Abstract). Appellant’s claim 1 is reproduced below:
1. A method for diagnosing and treating a subject having
polyps in the colon, the method comprising:
a) lysing a cell from a polyp sample taken from the
subject to form a cell lysate;
b) measuring the activation and/or expression level of at
least one signal transduction analyte selected from the group
consisting of HERl, HER2, HER3, cMET, PI3K, IGF1R, SHC,
CK, AKT, ERK, MEK, RSK, PRAS, RPS6 in the cell lysate,
wherein the measuring is performed with a proximity dual
detection assay;
c) determining the stage of cancer from step b, wherein
the stage of cancer is between Stage 0 to Stage IV; and
d) treating the subject with a therapeutic drug or a
polypectomy when the polyp sample is pre-cancerous or
cancerous and depending on the stage of cancer.
(Br. 23.) Appellant’s claims 3, 6–18, and 23–28 depend directly or
indirectly from Appellant’s claim 1 (see id. at 23–26).

Grounds of rejection before this Panel for review:
Claims 1, 3, 6–18, and 23–28 stand rejected under the written
description provision of 35 U.S.C. § 112(a).

3 Singh et al., US 2016/0305944 A1, published Oct. 20, 2016.
Appeal 2020-005090
Application 15/050,343

3
Claims 1, 3, 6–18, and 23–28 stand rejected under the written
description provision of 35 U.S.C. § 112(a).
Claims 1, 3, and 6–18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pevsner,4 Cortés,5 Li,6 Philp,7 and
Liu.8
Claims 1, 3, 6–18, 23, and 24 stand rejected under 35 U.S.C. § 101.

WRITTEN DESCRIPTION:
ISSUE
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?
FACTUAL FINDINGS (FF)
FF 1. Appellant discloses:
The term “colon cancer staging” includes the TNM
(tumors/nodes/metastases) system from the American Joint
Committee on Cancer as well as the broader Stage I-IV
groupings. Stage 0 or T is corresponds to a colon tumor
confined to the mucosa. Stage I or T1 corresponds to a colon
tumor that invades the submucosa. Stage I or T2 corresponds

4 Pevsner, US 2009/0170132 A1, published July 2, 2009.
5 Isabel Cortés et al., p85β phosphoinositide 3-kinase subunit regulates
tumor progression, 109 PNAS 11318–23 (2012).
6 Li Li et al., Association between Phosphatidylinositol 3-Kinase Regulatory
Subunit p85α Met326Ile Genetic Polymorphism and Colon Cancer Risk, 14
CLIN. CANCER RES. 633–37 (2008) (see also id. at 7963: Correction to Table
2).
7 Amanda J. Philp et al., The Phosphatidylinositol 3’-kinase p85α Gene Is an
Oncogene in Human Ovarian and Colon Tumors, 61 CANCER RESEARCH
7426–29 (2001).
8 Liu et al., WO 2011/088149 A2, published July 21, 2011.
Appeal 2020-005090
Application 15/050,343

4
to a colon tumor that invades the muscularis propria. Stage II-
A or T3 corresponds to a colon tumor that invades the
subserosa or beyond, though without involved of other organs.
Stage II-B or T4 indicates that a colon tumor invades adjacent
organs or perforates the viscreal peritoneum. Stage III-A or T1-
2 N1 corresponds to colon tumor metastasis to 1-3 regional
lymph nodes. Stage III-B or T3-4 N2 corresponds to colon
tumor metastasis to 4 or more regional lymph nodes. Stage IV
or any T, any N, and M1 corresponds to the presence of
distance metastasis.
(Spec. ¶ 309; see Ans.10 19 (Examiner finds that “[p]aragraph 30
of . . . [Appellant’s Specification] only discloses the definition of colon
cancer staging.”).)
FF 2. Appellant discloses:
In some embodiments, the invention provides a method for
staging colorectal cancer in a subject. In particular, the method
is useful for determining that an individual has localized (Stage
0 to Stage II; T to T3) colorectal cancer wherein the cancer cells
are confined within the wall of the colon.
(Spec. ¶ 59.11)
FF 3. Appellant discloses:
The method described herein can be used to monitor CRC
progression in an individual such that the activation and/or
expression levels of at least one analyte are measured samples
from both a first time point and a second (later) time point. An
increase in the activation level and/or expression of the analyte
indicates that the individual is progressing towards a late stage

9 Appellant and Examiner refer to this subject matter as found in Appellant’s
February 22, 2016, Specification paragraph 26 (see Br. 8, 17, 21; Ans. 20,
22–23).
10 Examiner’s April 27, 2020 Answer.
11 Appellant and Examiner refer to this subject matter as found in
Appellant’s February 22, 2016, Specification paragraph 49 (see Br. 8, 17;
Ans. 20).
Appeal 2020-005090
Application 15/050,343

5
of CRC. The method can also be used to determine whether the
individual should receive a therapeutic drug for the treatment of
CRC. In some instances, the therapeutic drug is directed to one
or more of the signal transduction analytes that are activated in
the patient.
(Spec. ¶ 69.12)
FF 4. Appellant discloses “[o]ne skilled in the art will appreciate that the
anticancer drugs described herein can be administered alone or as part of a
combined therapeutic approach with conventional chemotherapy,
radiotherapy, hormonal therapy, immunotherapy, and/or surgery” (Spec.
¶ 190).
ANALYSIS
Appellant’s claim 1, reproduced above, requires, inter alia, the
determination of the stage of cancer, wherein the stage of cancer is between
Stage 0 to Stage IV; and treating the subject with a therapeutic drug or a
polypectomy when the polyp sample is pre-cancerous or cancerous and
depending on the stage of cancer (see Br. 23).
Examiner finds that Appellant’s Specification “does not disclose
methods for treating a subject based on the stage of cancer, wherein the
stage of cancer is between Stage 0 to Stage IV” (Ans. 19).
Appellant contends that its Specification “recite[s] the various stages
of cancer” and this disclosure coupled with the disclosure in paragraphs 59
and 69 of Appellant’s Specification, “allow a skilled person to understand
and determine not only the cancer stage, but what therapeutic or therapy to
administer at that stage” (Br. 17). Thus, Appellant contends “a skilled

12 Appellant and Examiner refer to this subject matter as found in
Appellant’s February 22, 2016, Specification paragraph 55 (see Br. 8, 17–
18, 20; Ans. 20, 22).
Appeal 2020-005090
Application 15/050,343

6
person would understand that Appellant was in possession of the
embodiment of staging the cancer and administering a drug commensurate
with the stage of the cancer” (id. at 18). We are not persuaded.
As Examiner explains,
Although the stages are listed in . . . [Appellant’s
Specification] and [Appellant’s Specification discloses] . . . that
“[o]ne skilled in the art will appreciate that the anticancer drugs
described herein can be administered alone or as part of a
combined therapeutic approach with conventional
chemotherapy, radiotherapy, hormonal therapy,
immunotherapy, and/or surgery” there is nothing recited in the
specification which discloses the specific treatment for a
specific stage of colorectal cancer.
(Ans. 20–21 (citing Spec. ¶¶ 30, 190).) We find that Examiner has the better
position and, therefore, affirm the rejection of Appellant’s claim 1 under the
written description provision of 35 U.S.C. § 112(a).
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s Specification fails to provide written descriptive
support for the claimed invention. The rejection of claim 1 under the written
description provision of 35 U.S.C. § 112(a) is affirmed. Claims 3, 6–18, and
23–28 are not separately argued and fall with claim 1.

ENABLEMENT:
ISSUE
Does the evidence of record support Examiner’s conclusion that
undue experimentation would be required to practice the claimed invention?

Appeal 2020-005090
Application 15/050,343

7
FACTUAL FINDINGS (FF)
FF 5. We incorporate FF 1–4 herein.
FF 6. Examiner finds that Appellant’s “[S]pecification discloses that using
a known assay, activation levels of analytes, including the elected species
PI3K, in lysates from polyps with higher levels of phosphorylated HER3
were higher that polyps with normal levels of phosphorylated HER3
(Example 1)” (Ans. 21 (citing Spec. ¶¶ 204–217); see also Ans. 23).
FF 7. Appellant discloses:
The analyte data shows that activation levels of HER1, HER2,
HER3, PI3K, AKT, ERK, MEK and RSK of Group B were
statistically significantly higher than those of Group A. Thus, it
has been contemplated that the presence of high levels of
activated analytes in a polyp sample taken from a subject can
indicate that the subject is at risk of developing cancer.
(Spec. ¶ 21313; see Ans. 21.)
FF 8. Examiner finds that Cortés and Li “disclose[] that levels of activated
levels of PI3K were elevated in colorectal cancer tumors” (Ans. 21).
FF 9. Examiner finds that it was not known in the art “that the level of
activated PI3K was correlated with a particular stage of colorectal
carcinoma” (id.).
ANALYSIS
We agree with Appellant’s contention that “[t]he relative skill of those
in th[is] art . . . is high (M.D. or Ph.D. level)” (Br. 19).
We acknowledge Appellant’s characterization of the nature and
breadth of Appellant’s claim 1 (Br. 19–20) and further note that Appellant’s
claim 1, reproduced above, requires, inter alia, measuring the activation

13 Examiner refers to this subject matter as found in Appellant’s February
22, 2016, Specification paragraph 152 (see Ans. 19, 21).
Appeal 2020-005090
Application 15/050,343

8
and/or expression level of PI3K in the cell lysate, wherein the measuring is
performed with a proximity dual detection assay, determining the stage of
cancer, wherein the stage of cancer is between Stage 0 to Stage IV; and
treating the subject with a therapeutic drug or a polypectomy when the polyp
sample is pre-cancerous or cancerous and depending on the stage of cancer
(see Br. 23).
With regard to the direction, guidance, working examples provided by
Appellant’s disclosure, Examiner finds that Appellant’s “[S]pecification
does not disclose an actual correlation between the presence of high levels of
activated PI3K in a polyp sample and the stage of cancer” and that, although
it was known in the art that activated PI3K levels were elevated in colorectal
cancer tumors, it was not known in the art “that the level of activated PI3K
was correlated with a particular stage of colorectal carcinoma” (Ans. 21; see
also FF 8–9; cf. Br. 20–22). Stated differently, Examiner finds that
Appellant’s
[S]pecification discloses that it has been contemplated that the
presence of high levels of activated analytes in a polyp sample
can indicate that the subject is at risk of developing cancer but
does not actually demonstrate that high levels of activated
analytes in a polyp sample are correlated with the risk of
developing colorectal cancer, let alone any correlation between
activation levels of analytes and a specific stage of colorectal
carcinoma. The specification does not disclose any information
that would lead one to believe that levels of activated analytes
in a polyp sample could be used to determine the stage of
cancer.
(Ans. 23.)
We acknowledge Appellant’s contention that its disclosed method
can be used to monitor CRC progression in an individual such
that the activation and/or expression levels of the analyte(s) is
Appeal 2020-005090
Application 15/050,343

9
measured. An increase in the activation level and/or expression
of the analyte indicates that the individual is progressing
towards a late stage of CRC. The method can also be used to
determine whether the individual should receive a therapeutic
drug for the treatment of CRC. In some instances, the
therapeutic drug is directed to one or more of the signal
transduction analytes that are activated in the patient.
(Br. 20–21 (citing Spec. ¶ 69); see FF 3.)
As discussed above, however, we find that Examiner has the better
position, wherein Examiner explains,
Although the stages are listed in . . . [Appellant’s
Specification] and [Appellant’s Specification discloses] . . . that
“[o]ne skilled in the art will appreciate that the anticancer drugs
described herein can be administered alone or as part of a
combined therapeutic approach with conventional
chemotherapy, radiotherapy, hormonal therapy,
immunotherapy, and/or surgery” there is nothing recited in the
specification which discloses the specific treatment for a
specific stage of colorectal cancer.
(Ans. 20–21 (citing Spec. ¶¶ 30, 190).)
We recognize Appellant’s contentions that its Specification
exemplifies “how detecting the activation and/or expression level of at least
one signal transduction molecule in a cell lysate prepared from a polyp
sample taken from the individual, and comparing the activation and/or
expression level to a control,” discloses the various stages of CRC, discloses
that “an increase in the activation level and/or expression of the analyte
indicates that the individual is progressing towards a late stage of CRC,” and
discloses various anticancer therapy drugs (see Br. 21 (citing Spec. ¶¶ 30,
Appeal 2020-005090
Application 15/050,343

10
67,14 179,15 180,16 18917)). We find, however, that Examiner has the better
position. Specifically, Examiner finds
no data in [Appellant’s] [S]pecification nor the art that disclose
that levels of activated PI3 kinase in cancerous polyps can
distinguish the different stages of colorectal cancer. In fact,
Li . . . did not find any difference in genotypes typifying
activated PI3K and stage distribution . . . . Given the disclosure
of the specification and the art regarding the lack of any data
demonstrating that the stage of colorectal cancer can be
determined by measuring the activation level of PI3K, in the
cell lysate from polyps, one skilled in the art could not
predictably treat a subject depending on the stage of cancer
based on the activation level of PI3K in the cell lysate from
polyps.
(Ans. 24 (citing Li 636: col. 2, paragraph 2).)
For the foregoing reasons, we are not persuaded by Appellant’s
contention that because “the scope of the working Examples in the instant
specification meets the requirement to practice the invention commensurate
in scope with the currently pending claims, the specification clearly provides
working examples to enable the full scope of the invention as now claimed”
(Br. 22). For the same reasons, we are not persuaded by Appellant’s
contention that “[a]fter considering all the factors related to the enablement

14 Appellant and Examiner refer to this subject matter as found in
Appellant’s February 22, 2016, Specification paragraph 53 (see Br. 21; Ans.
22).
15 Appellant refers to this subject matter as found in Appellant’s February
22, 2016, Specification paragraph 118 (see Br. 21).
16 Appellant and Examiner refer to this subject matter as found in
Appellant’s February 22, 2016, Specification paragraph 119 (see Br. 21;
Ans. 23).
17 Appellant refers to this subject matter as found in Appellant’s February
22, 2016, Specification paragraph 128 (see Br. 21).
Appeal 2020-005090
Application 15/050,343

11
issue, Appellant concludes it would not require undue experimentation in
order to practice the claimed invention” (Br. 22).
CONCLUSION
The evidence of record supports Examiner’s conclusion that undue
experimentation would be required to practice the claimed invention. The
rejection of claim 1 under the enablement provision of 35 U.S.C. § 112(a) is
affirmed. Claims 3, 6–18, and 23–28 are not separately argued and fall with
claim 1.

OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 10. Pevsner “relates to methods of diagnosing carcinoma, providing a
prognosis for a carcinoma or assessing the likelihood that a tissue may
become cancerous” (Pevsner ¶ 2; see also id. ¶ 6 (Pevsner discloses “that
CRC tumors appear to arise as a result of the mutational activation of
oncogenes coupled with the mutational inactivation of tumor suppressor
genes”); Ans. 12).
FF 11. Pevsner discloses that “[a]lterations in signaling pathways
of . . . [, inter alia,] PI3K were detected in nearly two-thirds of breast and
colorectal tumors that were comprehensively examined” (Pevsner ¶ 16; see
Ans. 12).
FF 12. Pevsner discloses that “[t]he relative abundance of one or more
carcinoma associated marker may be compared to values obtained from
Appeal 2020-005090
Application 15/050,343

12
samples known to contain no cancerous cells to values representative of one
or more subjects known to have cancer at a particular stage” (Pevsner ¶ 22;
see id. ¶ 23 (Pevsner discloses that “the relative abundance of one or more
carcinoma marker may be predictive of the relative stage of carcinoma or of
benign cell changes. Such benign cell changes may be predictive of the
likelihood that a cell will become cancerous.”); see also Ans. 12 (Examiner
finds that “Pevsner disclose[s] that the relative abundance of one or more
carcinoma marker may be predictive of the relative stage of colorectal
carcinoma” (citing Pevsner ¶¶ 22, 23)); Ans. 18).
FF 13. Pevsner discloses that “[t]he sample used for determining the
presence of one or more carcinoma associated markers may be an in vivo
tissue sample . . . such as, for instance, a . . . biopsy of a colon polyp”
(Pevsner ¶ 25).
FF 14. Pevsner:
[P]rovides methods for diagnosing cancer or for assessing the
risk that a tissue or cell may become cancerous comprising the
steps of: (a) obtaining a biological sample from a patient; (b)
measuring an amount of one or more carcinoma associated
markers present in the biological sample; and (c) comparing the
amount of one or more carcinoma associated marker with a
predetermined value, whereby the amount of carcinoma
associated markers relative to the predetermined value indicates
the relative likelihood of a biological sample containing
cancerous cells or of a biological sample containing cells that in
the future will become cancerous. The predetermined value
may represent the amount of the carcinoma associated marker
present in a sample of tissue that is known to be non-cancerous
or to contain substantially no cancer cells.
(Pevsner ¶ 26; see also id. ¶ 74 (Pevsner exemplifies obtaining a colon tissue
biopsy from a patient and extracting proteins from the extracted colon
tissue); Ans. 11 (Examiner finds that Pevsner discloses “assessing the risk of
Appeal 2020-005090
Application 15/050,343

13
colorectal carcinoma development by detecting the presence of carcinoma
associated markers from a colon polyp using MALDI mass spectrometry”
(citing Pevsner ¶¶ 25–27)); Ans. 11–12 (Examiner finds that “Pevsner
disclose[s] measuring carcinoma associated markers using MALDI mass
spectrometry from trypsin digests of colon polyps” (citing Pevsner ¶¶ 22, 23,
25–27, 68)).)
FF 15. Examiner finds that “Philp disclose[s] methods for measuring
activation of PI3K” (Ans. 12 (citing Philp 7427: col. 1; 7428: col. 1)).
FF 16. Li discloses “that activation of the PI3K pathway occurs in most
tumor types through a variety of mechanisms” and that
[s]omatic mutations in the PIK3R1 gene, which encodes the
p85α regulatory subunit, have also been reported in primary
colon tumors. Expression of one of these mutant proteins led to
constitutive activation of the PI3K complex, providing the first
evidence that PIK3R1 could act as an oncogene in colon tumor
cells.
(Li 633: col. 2; see also id. at 635: col. 2 (Li “found a statistically significant
association between the PIK3R1 Met326Ile polymorphism and risk of colon
cancer”); Ans. 12, 17.)
FF 17. Cortés discloses “that increased p85β expression correlates with
PI3K pathway activation and tumor progression in [breast carcinoma (BC)]
and [colon adenocarcinoma (CC)]” (Cortés 11322: col. 1; see Ans. 12, 17).
FF 18. Examiner finds that the combination of Philp, Cortés, Li, and
Pevsner fails to “disclose measuring activation of PI3K using a
[Collaborative Enzyme Enhanced Reactive ImmunoAssay (CEER)]” and
relies on Liu to “disclose lysis of tumor cells to measure the expression
and/or activation of signal transduction molecules using CEER” and “that
CEER can detect the level of expression and/or activation of one or more
Appeal 2020-005090
Application 15/050,343

14
signal transduction molecules in cells obtained from colorectal tumor tissue
with a high level of sensitivity” (Ans. 13 (citing Liu ¶¶ 23, 36, 38, 42, 199,
Figure 6); see also Spec. ¶ 18 (Appellant discloses that CEER is a
“proximity dual detection assay”)).
FF 19. Liu discloses that “[i]nformation on the expression and/or activation
levels of components of signal transduction pathways derived from use of
the present invention can be used for cancer diagnosis, prognosis, and in the
design of cancer treatments” (Liu, Abstract; see also id. ¶ 33 (Liu discloses
“knowledge of the activity level of a particular signal transduction system
within a cancer cell prior to, during, and after treatment provides a physician
with highly relevant information that may be used to select an appropriate
course of treatment to adopt”); id. ¶ 89 (Liu discloses anticancer drugs); id.
¶ 155 (Liu discloses methods of administering anticancer drugs and that its
methods “can be used to select a suitable anticancer drug or combination of
anticancer drugs for the treatment of a tumor”)).
ANALYSIS
Based on the combination of Pevsner, Cortés, Li, Philp, and Liu,
Examiner concludes that, at the time Appellant’s invention was made,
[i]t would have been prima facie obvious to combine Pevsner
method for assessing the risk of colorectal carcinoma
development by detecting the presence of carcinoma associated
markers from a colon polyp with Philp, [Cortés,] and Li’s
disclosure that the activation of PI3K correlated with colorectal
cancer and risk of colorectal cancer to have a method for
diagnosing the risk of developing colorectal cancer (CRC) in a
subject comprising measuring the activation and/or expression
level of PI3K in the cell lysate from a polyp sample taken from
the subject.
(Ans. 12–13; see FF 10–17.) In this regard, Examiner reasons:
Appeal 2020-005090
Application 15/050,343

15
One of ordinary skill in the art would have been motivated to
apply Philp, [Cortés,] and Li’s disclosure that the activation of
PI3K correlated with colorectal cancer and risk of colorectal
cancer to Pevsner[’s] method for assessing the risk of colorectal
carcinoma development by detecting the presence of carcinoma
associated markers from a colon polyp because Pevsner
disclose[s] that colorectal carcinoma tumors appear to arise as a
result of the mutational activation of oncogenes . . . [and] that
alteration in the signaling pathway of PI3K were detecting in
nearly two-thirds of colorectal tumors.
(Ans. 12 (citing Pevsner ¶¶ 6, 16).)
Examiner further concludes that, at the time Appellant’s invention
was made, it would have been prima facie obvious to combine the “method
for diagnosing the risk of developing colorectal cancer (CRC) in a subject
comprising measuring the activation and/or expression level of PI3K in the
cell lysate from a polyp sample taken from the subject” made obvious by the
combination of Pevsner, Cortés, Li, and Philp
with Liu’s method of measuring the expression and/or
activation of signal transduction molecules using CEER to have
a method for diagnosing the risk of developing colorectal
cancer in a subject, comprising lysing a cell from a polyp
sample taken from the subject to form a cell lysate and
measuring the activation and/or expression level of PI3K in the
cell lysate, wherein the measuring step is performed with a
CEER.
(Ans. 13; see FF 10–19.) In this regard, Examiner reasons:
One of ordinary skill in the art would have been
motivated to apply Liu’s method of measuring the expression
and/or activation of signal transduction molecules using CEER
to Philp, [Cortés,] Li and Pevsner’s method for diagnosing the
risk of developing colorectal cancer (CRC) in a subject
comprising measuring the activation and/or expression level of
PI3K in the cell lysate from a polyp sample taken from the
subject because Liu disclose that CEER can detect the level of
Appeal 2020-005090
Application 15/050,343

16
expression and/or activation of one or more signal transduction
molecules in cells obtained from colorectal tumor tissue with a
high level of sensitivity.
(Ans. 13 (citing Liu ¶¶ 36, 42).) We find no error in Examiner’s prima facie
case of obviousness.
Appellant views each reference in isolation and, from this perspective,
asserts deficiencies in each reference taken alone, rather than in combination
(see Br. 13–15; cf. Ans. 17 (Examiner finds that “Appellant has not
specifically demonstrated which claim limitation is not present in the
complete set of art”)). As Examiner explains, “one cannot show
nonobviousness by attacking references individually where the rejections are
based on combinations of references” (Ans. 16). See In re Keller, 642 F.2d
413, 425 (CCPA 1981); see also In re Merck & Co., 800 F.2d 1091, 1097
(Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.”).
The combination of Pevsner, Cortés, Li, Philp, and Liu makes obvious
a method that comprises measuring the activation and/or expression level of
PI3K, a transduction analyte within the scope of Appellant’s claimed
invention (see generally FF 2, 6–9). Therefore, we are not persuaded by
Appellant’s contention to the contrary (see Br. 14–15).
The combination of Pevsner, Cortés, Li, Philp, and Liu makes obvious
a method that comprises taking a polyp sample from a subject to form a cell
lysate (see generally FF 4–5, 9). Therefore, we are not persuaded by
Appellant’s contention to the contrary (see Br. 14–15).
Appeal 2020-005090
Application 15/050,343

17
The combination of Pevsner, Cortés, Li, Philp, and Liu makes obvious
a method that comprises measuring the activation and/or expression level of
signal transduction analyte, within the scope of Appellant’s claim 1, in a cell
lysate using a proximity dual detection assay (see generally FF 2, 4–6, 9).
Therefore, we are not persuaded by Appellant’s contention to the contrary
(see Br. 14–15).
The combination of Pevsner, Cortés, Li, Philp, and Liu makes obvious
a method that comprises using markers to determine the stage of cancer and
administration of a therapy based upon the stage of cancer (see generally FF
3, 10). Therefore, we are not persuaded by Appellant’s contention to the
contrary (see Br. 14–15).
For the foregoing reasons, we are not persuaded by Appellant’s
unsupported contention that “[t]here is no reasonable expectation of success
of measuring . . . [PI3K] analytes . . . from polyp samples to determine the
stage of cancer and thereafter treat the same” (Br. 16).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Pevsner, Cortés, Li, Philp,
and Liu is affirmed. Claims 3 and 6–18 are not separately argued and fall
with claim 1.

Appeal 2020-005090
Application 15/050,343

18
SUBJECT MATTER ELIGIBILITY:
ISSUE
Does the preponderance of evidence of record support Examiner’s
finding that Appellant’s claimed invention is directed to patent-ineligible
subject matter?
PRINCIPLES OF LAW
A. Section 101
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 U.S. 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. 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 Court’s two-part framework, described in Mayo and Alice.
Alice, 573 U.S. 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. Kappos, 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);
Appeal 2020-005090
Application 15/050,343

19
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (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 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1853))); and manufacturing flour (Benson, 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
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 187; 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 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. (citation omitted)
(citing Benson and Flook); 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 turn 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 (internal quotation marks
Appeal 2020-005090
Application 15/050,343

20
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. (alterations in original) (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.
B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“Guidance”).18 “All USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance.” Id. at 51; see also October
2019 Update at 1.
Under the Guidance and the October 2019 Update, 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 activity such as a fundamental economic
practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)
(9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).19

18 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
19 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
Appeal 2020-005090
Application 15/050,343

21
Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is 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.
Guidance, 84 Fed. Reg. at 52–56.
ANALYSIS
Appellant’s claim 1 is representative and reproduced above.
(Step 1)
We first consider whether the claimed subject matter falls within the
four statutory categories set forth in § 101, namely “[p]rocess, machine,
manufacture, or composition of matter.” Guidance, 84 Fed. Reg. at 53–54;
see 35 U.S.C. § 101. Appellant’s claim 1 is directed to a method, i.e.,
processes, and, therefore, is directed to statutory subject matter (see Br. 23;
see also id. at 10 (Appellant contends that “it is clear that claim 1 is drawn to
a process or method”)). Therefore, proceed to the next steps of the analysis.
(Step 2A, Prong 1)
The method of Appellant’s claim 1 comprises the steps of:
b) measuring the activation and/or expression level of at least
one signal transduction analyte selected from the group
consisting of HER1, HER2, HER3, cMET, PI3K, IGFIR, SHC,

practical application. See Guidance — Section III(A)(2), 84 Fed. Reg. at
54–55.
Appeal 2020-005090
Application 15/050,343

22
CK, AKT, ERK, MEK, RSK, PRAS, RPS6 in the cell lysate,
and
c) determining the stage of cancer from step b, wherein the
stage of cancer is between Stage 0 to Stage IV.
(Br. 23.)
Examiner finds “the relationship between activation and/or expression
of a signal transduction analyte in a polyp sample and the stage of colorectal
cancer” is a natural phenomenon (Ans. 4). See, e.g., Cleveland Clinic
Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361 (Fed.
Cir. 2017) (a correlation between the presence of an analyte in a bodily
sample and disease risk is a natural phenomenon).
Examiner further finds that “‘determining the stage of cancer from
step b, wherein the stage of cancer is between Stage 0 to Stage IV[] is drawn
to an abstract idea’,” specifically a mental process, because it “merely
[requires] reviewing the data mentally and mentally comparing the
activation levels of PI3K and determining the stage of cancer” (Ans. 5). See
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1373 (Fed. Cir.
2011) (“[A] method that can be performed by human thought alone is
merely an abstract idea and is not patent-eligible under § 101.”); see also
FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1093 (Fed. Cir.
2016) (“[A]nalyzing information by steps people go through in their minds,
or by mathematical algorithms, without more,” are “essentially mental
processes within the abstract-idea category”); Guidance, 84 Fed. Reg. at 52–
55.
We find no error in Examiner’s finding that Appellant’s claim 1
“recite[s] judicial exceptions” (Ans. 5).

Appeal 2020-005090
Application 15/050,343

23
(Step 2A, Prong 2)
Having determined that Appellant’s claims recite a judicial exception,
the Guidance requires an evaluation as to whether the claim as a whole
integrates the recited judicial exception into a practical application of the
exception. See Guidance, 84 Fed. Reg. at 54.
The method of Appellant’s claim 1 comprises the additional steps or
limitations of:
a) lysing a cell from a polyp sample taken from the subject to
form a cell lysate;
b) measuring performed with a proximity dual detection assay;
and
d) treating the subject with a therapeutic drug or a polypectomy
when the polyp sample is pre-cancerous or cancerous and
depending on the stage of cancer.
(Br. 23.) The lysing and measuring steps of Appellant’s claim 1 are extra-
solution activities and, therefore, are not sufficient to integrate the recited
judicial exception into a practical application of the exception (see Ans. 10
(Examiner finds that “extra-solution activity does not transform th[e] patent-
ineligible claim into a patent-eligible claim”)). See Guidance, 84 Fed. Reg.
at 55; see also MPEP § 2106.05(g).
Further, although Appellant’s claim 1 includes a treatment step, it is
recited generically and does not provide any information as to how the
patient is to be treated, or what the treatment is, but instead covers any
possible treatment that a doctor decides to administer to the patient (see Ans.
9–10 (Examiner finds that “just inserting a generic treatment limitation does
not transform [a] patent-ineligible claim into a patent-eligible claim”)). See
Appeal 2020-005090
Application 15/050,343

24
Subject Matter Eligibility Example 42.20 “Like the claims in Mayo[, 566
U.S. at] 78 . . . , claim 1 here tells the relevant audience (doctors) about the
mathematical concepts and at most adds a suggestion that the doctors take
those laws into account when treating their patients.” (Id. at 4; see also Ans.
10.)
As Subject Matter Eligibility Example 42 makes clear, in contrast to
the generic therapy limitation recited in Appellant’s claim 1, Vanda “used a
judicial exception to identify patients in need of a particular treatment, and
then administered th[at] treatment to the identified patients” (Example 42 at
6 (citing Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d
1117 (Fed. Cir. 2018))). Thus, we are not persuaded by Appellant’s
contention that the limitations recited in Appellant’s claim 1 “encompass the
administration of a ‘particular treatment or prophylaxis’ . . . i.e., the
[generically recited] administration of a therapeutic agent that is capable of
treating cancer” or reliance on Vanda generally (see Br. 10–13).
(Step 2B)
Having determined that Appellant’s claims: (1) recite a judicial
exception and (2) do not integrate that exception into a practical application,
the Guidance requires that we evaluate whether Appellant’s claims: (a) add
a specific limitation beyond the judicial exception that is not “well-
understood, routine, conventional” in the field or (b) simply appends well-
understood, routine, conventional activities previously known to the

20 Appendix 1 to the October 2019 Update: Subject Matter Eligibility Life
Sciences & Data Processing Examples, Example 43,
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_app1.pdf.
https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_
20190107.pdf, Jan. 7, 2019.
Appeal 2020-005090
Application 15/050,343

25
industry, specified at a high level of generality, to the judicial exception.
Guidance, 84 Fed. Reg. at 52–56.
On this record, Examiner finds, and we agree, that when considered
individually and in combination Appellant’s claim 1 recites
the active method steps of “lysing a cell from a polyp sample
taken from the subject to form a cell lysate” and “measuring the
activation level of PI3K, in the cell lysate, wherein the
measuring is performed with a proximity dual detection assay”
set forth well-understood, routine and conventional activity
engaged in by scientists at the time the application was filed
and are the activities that a scientist would have relied upon to
achieve the goals of the invention.
(Ans. 6–7; see also FF 10–19.)
CONCLUSION
The preponderance of evidence of record supports Examiner’s finding
that Appellant’s claimed invention is directed to patent-ineligible subject
matter. The rejection of claim 1 under 35 U.S.C. § 101 is affirmed. Claims
3, 6–18, 23, and 24 are not separately argued and fall with claim 1.

Appeal 2020-005090
Application 15/050,343

26
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 6–18,
23, 24
101 Eligibility 1, 3, 6–18,
23, 24

1, 3, 6–18,
23–28
112(a) Written
Description
1, 3, 6–18,
23–28

1, 3, 6–18,
23–28
112(a) Enablement 1, 3, 6–18,
23–28

1, 3, 6–18 103 Pevsner, Cortés,
Li, Philp, Liu
1, 3, 6–18
Overall
Outcome
1, 3, 6–18,
23–28

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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2019).

AFFIRMED