KONINKLIJKE PHILIPS N.V.

Patent Trials and Appeals Board

Mar 8, 2021

2020003933 (P.T.A.B. Mar. 8, 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.
14/785,400 10/19/2015 WILHELMUS FRANCISCUS
JOHANNES VERHAEGH
2013P00315WOUS 6536
24737 7590 03/08/2021
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
WISE, OLIVIA M.
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/08/2021 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):
katelyn.mulroy@philips.com
marianne.fox@philips.com
patti.demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WILHELMUS FRANCISCUS JOHANNES VERHAEGH,
HENDRIK JAN VAN OOIJEN, ANJA VAN DE STOPLE, and
MARCIA ALVES DE INDA
____________

Appeal 2020-003933
Application 14/785,400
Technology Center 1600
____________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
JAMIE T. WISZ, Administrative Patent Judges.

WISZ, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 seeks review of claims 1–
12, 15, and 16. We have jurisdiction under 35 U.S.C. § 6(b).
For the reasons set forth below, 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
Koninklijke Philips N.V. Appeal Br. 3.
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Application 14/785,400
2

CLAIMED SUBJECT MATTER
The Specification describes “a specific method for determining a risk
score that indicates a risk that a clinical event will occur within a certain
period of time.” Spec. 2. Claims 1 and 11 are independent claims. Claim 1
is illustrative and is set forth below:
1. A method comprising:
inferring, by a processor, activities of two or more
cellular signaling pathways in a tissue and/or cells and/or a
body fluid of a subject based at least on the expression levels of
one or more target gene(s) of the cellular signaling pathways
measured in an extracted sample of the tissue and/or the cells
and/or the body fluid of the subject, and
determining, by the processor, a risk score that indicates
a risk that a clinical event will occur within a certain period of
time, based at least in part on a combination of the inferred
activities,
wherein the cellular signaling pathways comprise a Wnt
pathway, an ER pathway, and an HH pathway,
wherein the risk score is defined such that the indicated
risk that the clinical event will occur within the certain period
of time decreases with an increasing PER and increases with an
increasing max(PWnt, PHH), and
wherein PER, PWnt, and PHH denote the inferred activities
of the ER pathway, the Wnt pathway, and the HH pathway,
respectively.

Appeal Br. 15 (Claims Appendix). Independent claim 11 recites an
apparatus with a processor to implement these steps. Id. at 19–20.
REJECTIONS
The Examiner rejected claims 1–12, 15, and 16 under 35 U.S.C. § 101
as being directed to patent-ineligible subject matter.
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I. 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.
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 whether the claim recites an abstract idea. 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);
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
that recite abstract ideas, but are nonetheless 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,
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4
making waterproof cloth, vulcanizing India rubber, smelting ores” (id. at 182
n.7 (quoting Corning v. Burden, 56 U.S. 252, 267–68 (1854))); and
manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94
U.S. 780, 785 (1876))).
If the claim is “directed to” an abstract idea, we turn to the second part
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.
(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)
(“2019 Revised Guidance”).2 “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.

2 The Office issued further guidance on October 17, 2019. 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.p
df).
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Under the 2019 Revised 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”).3
2019 Revised 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 (“Step 2B”).
2019 Revised Guidance, 84 Fed. Reg. at 52–56.

3 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
practical application. See 2019 Revised Guidance — Section III(A)(2), 84
Fed. Reg. 54–55.
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II. ANALYSIS
Applying the 2019 Revised Guidance to the facts on this record, we
find that claims 1–12, 15, and 16 are directed to patent-ineligible subject
matter.
Claim 1 is directed to a method for determining a risk score that
indicates a risk that a clinical event will occur within a certain time period.
Following the first step of the Mayo/Alice analysis, we find that the claim is
directed to a “process,” and therefore falls into one of the broad statutory
categories of patent-eligible subject matter under 35 U.S.C. § 101. We thus
proceed to Step 2A, Prong One, of the 2019 Revised Guidance.
A. Guidance Step 2A, Prong 1
The 2019 Revised Guidance instructs us first to determine whether
any judicial exception to patent eligibility is recited in the claim. The 2019
Revised Guidance identifies three judicially-excepted groupings identified
by the courts as abstract ideas: (1) mathematical concepts, (2) certain
methods of organizing human activity such as fundamental economic
practices, and (3) mental processes.
The Examiner finds that the claims recite the abstract ideas of mental
processes and mathematical concepts. Final Act. 6–7. Specifically, the
Examiner finds that the limitation of “inferring activity of two or more
cellular signaling pathways . . . equate to mental evaluations and judgements
that can be practically performed in the human mind.” Id. at 6. The
Examiner also finds that
[t]he limitations for determining a risk score defined such that
the indicated risk that the clinical event will occur within the
certain period of time decreases with an increasing PER and
increases with an increasing max(PWnt, PHH), using the
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mathematical expression set forth in claim 2 or determining a
combined risk score in claim 9 equate to mathematical
calculations.
Id. at 7.
We find that the claims recite mental processes and mathematical
concepts. More specifically, claim 1, reproduced above, recites the steps of
“inferring . . . activities of two or more cellular signaling pathways” and
“determining . . . a risk score.” Appeal Br. 15. We agree with the Examiner
that the “‘inferring step’ requires evaluating or analyzing at least one data
point to make a determination on the activity of the cellular signaling
pathway at least two times” which “can be practically performed in the
human mind.” Ans. 4. We also find that, although a mathematical formula
is not recited, per se, under the broadest reasonable interpretation, the
“inferring step” involves mathematical relationships and is, therefore, a
mathematical concept. For example, the Specification states that the
inferring step may be performed by
constructing a probabilistic model (e.g., Bayesian model) and
incorporating conditional probabilistic relationships between
expression levels of a number of different target genes and the
activity of the cellular signaling pathway, such a model can be
used to determine the activity of the cellular signaling pathway
with a high degree of accuracy.
Spec. 12. Therefore, the “inferring” step encompasses mathematical
relationships/models.
With regard to the step of “determining . . . a risk score,” the
Specification states that “many different formulas can be devised for
determining a risk score that indicates a risk that a clinical event will occur
within a certain period.” Spec. 40. Therefore, the “determining” step
encompasses mathematical calculations.
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Appellant asserts that the “inferring” step of claim 1 “cannot be
practically performed in a human brain” and, therefore, does not recite a
mental process. Appeal Br. 9. Appellant also asserts that this step does not
include a limitation of a “mathematical model” and, similar to claim 4 of
Example 46 of the 2019 Subject Matter Eligibility Examples (“2019
Eligibility Examples”), the claim “does not set forth or describe
‘mathematical concepts’ such as mathematical relationships, mathematical
formulas or equations, and mathematical calculations.” Reply 5.
We are not persuaded by this argument. While the performance of the
“inferring step” may be made easier with the use of a computer, the recited
inferences can be performed in the human mind or with the aid of pen and
paper. Specifically, to infer the activities of two or more signaling pathways
as claimed, one need only look at the results of gene expression
measurements of the target genes. Furthermore, even if we were to find that
this step could not be performed in the human mind, this step still recites
mathematical concepts. The October 2019 Update provides examples of
claims that recite mathematical concepts without explicitly reciting a
numerical formula or equation. See October 2019 Update at 3–4. The
October 2019 Update cites to SAP Am., Inc. v. InvestPic, LLC, 898 F.3d
1161, 1163–65 (Fed. Cir. 2018) in which claims to “a method of providing a
statistical analysis of investment data” were found to be patent ineligible.
October 2019 Update at 4. Similarly, claim 1 recites “inferring . . . activities
of two or more cellular signaling pathways” and “determining . . . a risk
score” that recite the “act of calculating using mathematical methods to
determine a variable or number” and/or performing a mathematical
operation. See id.
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Accordingly, we conclude that the above-identified limitations of
claim 1 recite the judicial exceptions of mental processes and mathematical
concepts.4
B. Guidance Step 2A, Prong 2
Having determined that the claims recite a judicial exception, we next
consider whether the claims integrate the judicial exception into a practical
application. “[I]ntegration into a practical application” requires that the
claim recite an additional element or a combination of elements, that when
considered individually or in combination, “apply, rely on, or use the
judicial exception in a manner that imposes a meaningful limit on the
judicial exception, such that the claim is more than a drafting effort designed
to monopolize the judicial exception.” 2019 Revised Guidance 54.
Here, there is no practical integration of the abstract idea. Other than
the judicial exceptions, the claims do not recite any additional elements that
integrate the judicial exceptions into a practical application. We agree with
the Examiner that “[t]he claims do not recite an additional element that
applies or uses the judicial exception to effect a particular treatment or
prophylaxis for a disease or medical condition or reflects in an additional
element an improvement to a computer or other technology.” Final Act. 7.
While claim 5 recites determining a treatment recommendation based on the

4 The Examiner also found that the claims recite a law of nature because
they “recite a correlation between expression levels of target gene(s), which
is a natural product, in an individual and their risk of a clinical event.” Final
Act. 7. Appellant does not appear to respond to this aspect of the rejection.
See generally Appeal Br., Reply. Because we find that the claims recite
ineligible subject matter in that they recite mental processes and
mathematical concepts, we need not address this aspect of the rejection.
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risk of the clinical event, there are no limitations for a particular treatment or
particular condition. While a particular treatment may integrate the
exception into a practical application, “[t]he treatment or prophylaxis
limitation must be ‘particular,’ i.e., specifically identified so that it does not
encompass all applications of the judicial exception(s).” October 2019
Update at 14.
Here, the treatment step recited in claim 5 does not require any
particular treatment, but encompasses any treatment that is administered
based in part on the determination of an indicated risk that a clinical event
will occur within a certain period of time which itself is based on the judicial
exception. Thus, the treatment step of claim 5 amounts merely to
instructions to “apply” the recited judicial exception.
Appellant argues that claim 1 “improves the functioning of a
computer or other technology.” Appeal Br. 11. Appellant also argues that
claim 1 “may provide an improvement (e.g., “to make an educated guess on
the prognosis of a patient”) described in the specification.” Id. at 12.
We are not persuaded by Appellant’s arguments. Appellant has not
provided adequate evidence of a technical solution to a technical problem or
technology. Rather, the improvement is to the abstract idea itself (e.g.,
determining a risk score in order to provide a better prognosis to a patient).
In SAP, the court held the claims at issue to be patent ineligible, because
“the focus of the claims is not any improved computer or network, but the
improved mathematical analysis; and indeed, the specification makes clear
that off-the-shelf computer technology is usable to carry out the analysis.”
898 F.3d at 1168. The court explained:
We readily conclude that there is nothing in the claims
sufficient to remove them from the class of subject matter
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ineligible for patenting and transform them into an eligible
application. What is needed is an inventive concept in the non-
abstract application realm.
Id.
Here, the improvement is to the method of determining a risk score
that a clinical event will occur within a certain period of time. The
improvement is integral to the abstract idea of mathematical concepts and
therefore is not to the “non-abstract application realm.” SAP, 898 F.3d at
1168.
Therefore, on this record, we conclude that the mental processes and
mathematical concepts in Appellant’s claim 1 are not integrated into a
practical application.
C. Guidance Step 2B
Having determined that the judicial exception is not integrated into a
practical application, we next evaluate the additional elements individually
and in combination to determine whether they provide an inventive concept,
such as a specific limitation beyond the judicial exception that is not well-
understood, routine, and conventional in the field, or whether such elements
simply append well-understood, routine, conventional activities previously
known to the industry, specified at a high level of generality, to the judicial
exception. See 84 Fed. Reg. 51.
Appellant asserts that “claim 1 provides an inventive concept, and
thus that even if claim 1 is directed to a judicial exception, which Appellant
does not agree with, claim 1 is still patent eligible.” Appeal Br. 13.
We are not persuaded by Appellant’s arguments. First, novelty and
non-obviousness are not the test of eligibility under Section 101. A claim
can be new and unobvious and still be ineligible for a patent because it is
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directed to an abstract idea without significantly more. See Data Engine
Techs. LLC v. Google LLC, 906 F.3d 999, 1011 (Fed. Cir. 2018) (“The
eligibility question is not whether anyone has ever used tabs to organize
information. That question is reserved for §§ 102 and 103”).
Second, Appellant did not direct us to anything in the Specification
indicating that any steps or components recited in the claims are not generic
or conventional. For example, the Specification describes digital processing
devices such as a handheld device, a notebook computer, a desktop
computer, a tablet computer or device, or a remote network server for use in
the claimed method. Spec. 49. Appellant points to no additional steps that
could not be performed without using a generic computer. The use of a
generic computer to perform generic computer functions that are “well-
understood, routine, conventional activit[ies]” previously known in the
industry is not enough to transform the abstract idea into a patent-eligible
invention. See Alice, 573 U.S. at 225–26.
Accordingly, the preponderance of evidence of record supports the
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 2–12, 15, and 16 are not separately argued and fall with
claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
CONCLUSION
For the reasons described herein and those already of record, we
affirm the Examiner’s rejection of claims 1–12, 15, and 16.

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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–12, 15,
16
101 Eligibility 1–12, 15, 16
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).
AFFIRMED