Martin G. Reese et al.

Patent Trials and Appeals Board

Aug 28, 2019

14879912 - (D) (P.T.A.B. Aug. 28, 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.
14/879,912 10/09/2015 Martin G. Reese 28436-701.305 8720
21971 7590 08/28/2019
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
BRUSCA, JOHN S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
08/28/2019 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):
patentdocket@wsgr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte MARTIN G. REESE and CHARLES WHITE
____________________

Appeal 2018-006646
Application 14/879,912
Technology Center 1600
____________________

Before DEMETRA J. MILLS, JOHN E. SCHNEIDER, and
DAVID COTTA, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

This is an Appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims as directed to patent ineligible subject matter.1 We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 The rejections of the claims under 37 under 35 U.S.C.112 (pre AIA),
second paragraph and on the ground of nonstatutory double patenting have
been withdrawn by the Examiner and are thus no longer part of this appeal.
Ans. 3.

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THE CLAIMED SUBJECT MATTER
The Specification provides that, “a comprehensive analysis of the
relationship between an individual’s genotype and phenotype requires a
scoring matrix of variables along various dimensions and a method of using
this matrix to determine the probability that a given genotype in a given
individual will result in a given phenotype.” Spec. ¶ 28.
Regarding the claimed multivariate scoring matrix, the Specification
discloses that, all gene splice sites relevant to a variant
are first identified by mRNA identification and alignments
to the genomic DNA either through existing annotations or new
annotations, thereby enabling both informatic and chemical
retrieval of 5’ and 3’ splice site sequence regions. Second, variants
with SNPs within these splice site regions and the associated sites
are identified by the integrating and mapping of public and private
mutations within these splicing associated sites. Third, the wild-
type or original sequences and the mutated sequences are scored
with one or more predictive models selected from the universe of:
statistical models, such as weight matrix, Bayesian, hidden
Markov models, semi- or general hidden Markov models;
artificial intelligence models; and discriminative and predictive
models related to binding affinity. This process results in splicing
strength scores for the original variant and the variant with the
SNP. The difference of these scores or any other metric applied to
these scores can then be used to preselect markers for genotyping
analysis and to score, rank, and prioritize factors in the
construction of a multivariate scoring matrix.

Spec. ¶ 69.

Appellants do not argue the claims separately in the Brief, therefore
we select claim 1, as a representative claim for purposes of this decision.
Claim 1 reads as follows:
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1. A computer-implemented method for providing a
therapeutic intervention to an individual based on an evaluation
that is with respect to a probability that said individual will
exhibit one or more phenotypic attributes using a multivariate
scoring matrix that relates a plurality of genomic markers with
probabilities of exhibiting phenotypic attributes, comprising:
(a) evaluating each member of a set of genomic markers
in data generated from sequencing a biological sample of said
individual, wherein said genomic markers of said set are
preselected based on association or other studies to be linked
with at least a subset of said phenotypic attributes, and further
wherein said genomic markers map to at least 1,000 sites;
(b) accessing a database that comprises said multivariate
scoring matrix comprising scoring matrix vectors, wherein said
multivariate scoring matrix is algorithmically constructed and
manipulated to relate said plurality of genomic markers with
said probabilities of exhibiting said phenotypic attributes,
wherein said probabilities are based at least in part on
ontological relevance, and wherein said plurality of genomic
markers comprise said genomic markers that map to said at
least 1,000 sites;
(c) using said database to compare each of said genomic
markers of said set to said multivariate scoring matrix to obtain
marker scores for each of said genomic markers, wherein each
of said marker scores is indicative of a probability of exhibiting
said one or more phenotypic attributes;
(d) based on said marker scores, determining said
probability that said individual will exhibit said one or more
phenotypic attributes among said phenotypic attributes, to yield
said evaluation; and
(e) providing said therapeutic intervention to said
individual based on said evaluation.

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DISCUSSION
I. Patent Eligible Subject Matter, Principles of Law
To determine whether claims are patent eligible under 35 U.S.C.
§ 101, we apply the Supreme Court’s two-step framework articulated in
Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). First, we determine
whether the claims are directed to a patent-ineligible concept: laws of
nature, natural phenomena, and abstract ideas. Id. at 216–17. If so, we then
proceed to the second step to consider the elements of the claims
“individually and ‘as an ordered combination’” to determine whether there
are additional elements that “‘transform the nature of the claim’ into a
patent-eligible application.” Id. at 217. In other words, the second step is to
“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
217–18 (alteration in original).
The Federal Circuit has described the Alice step-one inquiry as
looking at the “focus” of the claims, their “character as a whole,” and the
Alice step-two inquiry as looking more precisely at what the claim elements
add—whether they identify an “inventive concept” in the application of the
ineligible matter to which the claim is directed. See Elec. Power Grp., LLC
v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016); Enfish, LLC v.
Microsoft Corp., 822 F.3d 1327, 1335–36 (Fed. Cir. 2016); Internet Pat.
Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed. Cir. 2015).

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A. 2019 Revised Guidance
The PTO recently published revised guidance that governs all patent-
eligibility analysis under Alice and § 101 effective as of January 7, 2019.
See USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, 84
Fed. Reg. 50 (January 7, 2019) (“2019 Revised Guidance”). According to
the 2019 Revised Guidance and under Alice step 1 (abstract idea), we first
look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, mental processes,
or certain methods of organizing human activity such as a
fundamental economic practice or managing personal
behavior or relationships or interactions between people);
and

(2) additional elements that integrate the judicial exception
into a practical application (see Manual of Patent Examining
Procedure (“MPEP”) §§ 2106.05(a)–(c), (e)–(h)).2
See id. at 51–52, 55, Revised Step 2A, Prong One (Abstract Idea) and Prong
Two (Integration into A Practical Application).
A claim that integrates a judicial exception into a practical application
applies, relies on, or uses 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. See id. at 54.
When the judicial exception is so integrated, then the claim is not directed to
a judicial exception and is patent eligible under § 101. Id.
Only if a claim: (1) recites a judicial exception, and (2) does not
integrate that exception into a practical application, do we then evaluate

2 All references to the MPEP are to the Ninth Edition, Revision 08–2017
(rev. Jan. 2018).
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whether the claim provides an “inventive concept” under Alice step 2. See
id. at 56; Alice, 573 U.S. at 217–18. For example, we look to whether the
claim:
1) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field
(see MPEP § 2106.05(d)); or

2) simply appends well-understood, routine, and conventional
activities previously known to the industry, specified at a
high level of generality, to the judicial exception.
See, 2019 Revised Guidance, 84 Fed. Reg. at 56.
Because there is no single definition of an “abstract idea” under Alice
step 1, the PTO has recently recognized, for purposes of clarity,
predictability, and consistency, key concepts identified by the courts as
abstract ideas to explain the “abstract idea” exception. These concepts
include the following three groupings:
1. Mathematical concepts—mathematical relationships, mathematical
formulas or equations, mathematical calculations;

2. Mental processes—concepts performed in the human mind
(including an observation, evaluation, judgment, opinion); and

3. Certain methods of organizing human activity—fundamental
economic principles or practices (including hedging, insurance,
mitigating risk); commercial or legal interactions (including
agreements in the form of contracts; legal obligations; advertising,
marketing or sales activities or behaviors; business relations);
managing personal behavior or relationships or interactions
between people (including social activities, teaching, and
following rules or instructions).
See id. at 52.
According to the 2019 Revised Guidance, “[c]laims that do not recite
[subject] matter that falls within these enumerated groupings of abstract
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ideas should not be treated as reciting abstract ideas,” except in rare
circumstances. Id. at 53. Even if the claims recite any one of these three
groupings of abstract ideas, these claims are still not “directed to” a judicial
exception (abstract idea), and thus are patent eligible, if “the claim as a
whole integrates the recited judicial exception into a practical application of
that exception.” Id.
For example, limitations that are indicative of “integration into a
practical application” include:
1. Improvements to the functioning of a computer, or to any other
technology or technical field — see MPEP § 2106.05(a);
2. Applying the judicial exception with, or by use of, a particular
machine — see MPEP § 2106.05(b);
3. Effecting a transformation or reduction of a particular article to
a different state or thing — see MPEP § 2106.05(c); and
4. Applying or using the judicial exception in some other
meaningful way beyond generally linking the use of the judicial
exception to a particular technological environment, such that
the claim as a whole is more than a drafting effort designed to
monopolize the exception — see MPEP § 2106.05(e).
In contrast, limitations that are not indicative of “integration into a
practical application” include:
1. Adding the words “apply it” (or an equivalent) with the judicial
exception, or merely include instructions to implement an
abstract idea on a computer, or merely uses a computer as a tool
to perform an abstract idea — see MPEP § 2106.05(f);
2. Adding insignificant extra-solution activity to the judicial
exception — see MPEP § 2106.05(g); and
3. Generally linking the use of the judicial exception to a
particular technological environment or field of use — see
MPEP § 2106.05(h). v
See 2019 Revised Guidance, 84 Fed. Reg. at 54–55 (“Prong Two”).

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B. Rejection of Claims 1, 3, 9, 11, 13, 15, 17–19, 22–27, 29,
and 31–373 under 35 U.S.C. § 101

The Examiner’s Rejection
The Examiner rejects representative claim 1 under 35 U.S.C. § 101
because the claim is directed to a law of nature/abstract idea and does not
recite additional elements that amount to significantly more than the judicial
exception itself. Final Act. 4–5. The Examiner finds that claim 1 recites a
natural correlation between genomic markers and a phenotype and also
recites mental steps.
The Examiner finds that,
Independent claim 1 is directed to a judicial exception of
an abstract idea of evaluating genomic markers of an individual
by use of a database that relates markers with a probability of
an associated phenotype, which is similar to the abstract idea of
comparing information regarding a sample or test subject to a
control or target data at issue in Univ. of Utah Research Found.
v. Ambry Genetics Corp., (774 F.3d 755, 113 USPQ2d 1241
(Fed. Cir. 2014)).

Final Act. 5.
Appellants’ Position
Appellants submit that,
the claims are not directed to a judicial exception for at least the
reason that (i) the claims are directed to an improvement to a
computer-related technology, and (ii) the claims are directed to
a particular way to achieve a desired outcome that do not
altogether preempt an outcome or idea.
App. Br. 12. Appellants argue that, the claimed method “improves upon

3 Claims 5–7, 10, 16, 20, and 21 have been withdrawn from consideration.
App. Br. 25, 26 (Claims App’x).
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computer-implemented bioinformatics methods.” Id. at 14 (emphasis
omitted). Appellants argue that:
The method of claim 1 provides improvements to a
computer technology at least because it allows for analysis of
many markers (e.g., genomic markers that map to at least 1,000
sites) and providing a therapeutic intervention based on a
phenotypic attribute without requiring the phenotypic attribute
to be manifest ( e.g., “determining said probability that said
individual will exhibit said one or more phenotypic attributes
among said phenotypic attributes, to yield said evaluation; and [
] providing said therapeutic intervention to said individual
based on said evaluation”).
Id.
For the reasons discussed below, we are not persuaded that the
Examiner erred in determining that the pending claims are directed to patent
ineligible subject matter including, a law of nature and an abstract idea.

C. Application of 2019 Revised Guidance
Turning now to the 2019 Revised Guidance, we consider whether the
claims are directed to any judicial exceptions, including certain groupings of
abstract ideas, in particular: (a) mathematical concepts, (b) methods of
organizing human activity, (c) mental steps, and (d) laws of nature. 2019
Revised Guidance, 84 Fed. Reg. at 52.

Alice/Mayo—Step 1 (Law of Nature/Abstract Idea)
Step 2A–Prongs 1 and 2 identified in the Revised Guidance
Step 2A—Prong 1
The Judicial Exception
Viewing the Examiner’s rejection through the lens of the Office’s
recent guidance, we first determine whether the claim recites a judicial
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exception to patentability and then determine whether the claim—considered
as a whole-is directed to that judicial exception.
Claim 1 recites the mental processes of “evaluating” (step a, b, d),
“comparing” (step c), and “determining” (step d), which fall into the
category of “abstract ideas”. If a claim, under its broadest reasonable
interpretation, covers performance in the mind but for the recitation of
generic computer components, then it is still in the mental processes
category unless the claim cannot practically be performed in the mind. See
Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed.
Cir. 2016).
The claim also recites the judicial exception of mathematical
concepts, including an “algorithmically constructed” “multivariate scoring
matrix,” and “probabilities of exhibiting phenotypic attributes.” The
mathematical concepts used in the claimed method can also be considered as
abstract ideas for evaluation of the law of nature. Parker v. Flook, 437 U.S.
584, 594 (1978) (“[T]he discovery of [a mathematical formula] cannot
support a patent unless there is some other inventive concept in its
application.”) (See also mathematical concepts - 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)).
Thus, representative claim 1 is directed to a judicial exception to
patentability.

Step 2A—Prong 2 (Integration into Practical Application)
See 2019 Revised Guidance, Revised Step 2A, Prong Two.
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As discussed above, we find that Appellant’s claim 1 recites a judicial
exception to patentability of mental processes and mathematical concepts.
Under the Revised Guidance, we next determine “whether the claim recites
additional elements that integrate the exception into a practical application
of that exception.” 84 Fed. Reg. at 54, italicized emphasis added.
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’l Ltd., 887 F.3d
1117, 1134–35 (Fed. Cir. 2018). (emphasis added).
The Examiner finds that independent claim 1 comprises an additional
element of providing a generic therapeutic intervention to an individual. Final
Act. 6.
We agree with the Examiner that claim 1 comprises an additional
element of providing a generic therapeutic intervention to an individual,
which is a routine clinical practice, and is not a practical application of an
abstract idea.

Evaluation of additional claim elements/specific claim steps
The mathematical applications recited in claims 1 do not: (1) improve
the functioning of a computer or other technology; (2) are not applied with
any particular machine (except for a generic computer); (3) do not effect a
transformation of a particular article to a different state; and (4) are not
applied in any meaningful way beyond generally linking the use of the
judicial exception to a particular technological environment, such that the
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claim as a whole is more than a drafting effort designed to monopolize the
exception. See MPEP §§ 2106.05(a)–(c), (e)–(h).
The additional elements recited in Appellants’ claims do not contain
any “inventive concept” or add anything “significantly more” to transform
the abstract concept into a patent-eligible application. We find that
Appellants’ invention does not (1) provide a technical solution to a technical
problem unique to the Internet, i.e., a “solution . . . necessarily rooted in
computer technology in order to overcome a problem specifically arising in
the realm of computer networks” (see DDR Holdings, LLC v. Hotels.com,
L.P., 773 F.3d 1245, 1257 (Fed. Cir. 2014)) or (2) “entail[] an
unconventional technological solution (enhancing data in a distributed
fashion) to a technological problem (massive record flows which previously
required massive databases)” and “improve the performance of the system
itself” (see Amdocs Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1300, 1302
(Fed. Cir. 2016)).
In particular, claim 1 recites, “A computer-implemented method for
providing a therapeutic intervention to an individual based on an evaluation
that is with respect to a probability that said individual will exhibit one or
more phenotypic attributes using a multivariate scoring matrix that relates a
plurality of genomic markers with probabilities of exhibiting phenotypic
attributes.” The preamble of the claims does not indicate how the detected
genomic marker phenotypic probability is specifically used to treat patients.
Nor does the preamble of the claim specify a particular treatment protocol
for the probable phenotypic attribute, or address epigenetic considerations
with respect to gene expression of phenotype.
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Step (a) of claim 1 recites, “evaluating each member of a set of
genomic markers in data generated[]from sequencing a biological sample of
said individual, wherein said genomic markers of said set are preselected
based on association or other studies to be linked with at least a subset of
said phenotypic attributes, and further wherein said genomic markers map to
at least 1,000 sites.” As discussed above, this step recites a judicial
exception and thus does not, by itself integrate the judicial exception into a
practical application. Moreover, This step does not specifically indicate how
the genomic markers are evaluated, and only specifies that the markers are
preselected based on a generic subset of phenotypic attributes. How the
subset of attributes is determined is not indicated. This step is considered a
mental step/process as it is a process of evaluation, see 2019 Revised
Guidance, 84 Fed. Reg. at 52, and is thus not a practical application of a
judicial exception. To the extent this step is considered to require one to
perform physical steps, it would not change the results of our analysis,
because those steps involve the collection of information that is necessary to
perform the evaluation of genomic markers and subsequent correlation with
phenotype, i.e. mere data gathering.
The end result of performing the steps of claim 1, is an analysis of
naturally occurring genomes and their associated phenotype. This
information is generically specified to determine a “treatment,” and, without
more, amounts to “applying” the recited judicial exception to a field of use.
Claims that amount to nothing more than an instruction to apply the abstract
idea using a generic computer do not render an abstract idea patent eligible.
Nor does adding the words “apply it” (or an equivalent) to a judicial
exception, or merely including instructions to implement an abstract idea on
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a computer, or merely using a computer as a tool to perform an abstract idea,
render an abstract idea patent eligible. See MPEP § 2106.05(f).
Significantly, unlike the claim in Vanda Pharms. Inc. v. West-Ward
Pharms. Int’l Ltd., 887 F.3d 1117, 1135 (Fed. Cir. 2018), claim 1 recites a
use of the claimed method at a high level of generality, requiring only that
“therapeutic intervention” be provided to “said individual based on said
evaluation.” In Vanda, the claim was found to be a patent-eligible
application because the claimed step of identifying a patient’s CYP2D6
genotype was used to determine how much of a drug to actually administer
to the patient experiencing a particular condition, schizophrenia, i.e., the
claim was directed to treating a specific patient rather is a specific way. The
court in Vanda found that the genotype of the patient (a naturally-occurring
phenomenon) was integrated into a new way of using a specific existing
drug, iloperidone, to treat a patient having a specific condition, and thus was
patent-eligible. Id.
Rejected claim 1 uses the natural occurring genomic relationship
between genes and their phenotypic expression, but unlike Vanda, the
appealed claim does not require this result to be applied in a specific,
practical way, such as a specific/particular treatment. Thus, like Mayo, the
“ordered combination [of steps] adds nothing to the laws of nature that is not
already present when the steps are considered separately.” Mayo, 566 U.S.
at 79. The claims provide no specific instruction to the skilled artisan who
wants to use the correlation between the phenotypic expression of a gene
and a treatment regimen.
Claim 1, step (b), describes “accessing a database that comprises said
multivariate scoring matrix comprising scoring matrix vectors, wherein said
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multivariate scoring matrix is algorithmically constructed and manipulated
to relate said plurality of genomic markers with said probabilities of
exhibiting said phenotypic attributes, wherein said probabilities are based at
least in part on ontological relevance, and wherein said plurality of genomic
markers comprise said genomic markers that map to said at least 1,000
sites.” This step is directed to an abstract idea as it recites purely
mathematical concepts, mathematic data manipulation and statistical
analysis of data and thus does not integrate the recited judicial exception into
a practical application.
Claim 1, step (c) recites, “using said database to compare each of said
genomic markers of said set to said multivariate scoring matrix to obtain
marker scores for each of said genomic markers, wherein each of said
marker scores is indicative of a probability of exhibiting said one or more
phenotypic attributes.” This step is directed to an abstract idea as it recites
purely mathematic concepts, data manipulation and statistical calculations
and thus does not integrate the recited judicial exception into a practical
application.
Claim 1, step (d), recites, “based on said marker scores, determining
said probability that said individual will exhibit said one or more phenotypic
attributes among said phenotypic attributes, to yield said evaluation.” This
step is directed to an abstract idea as it recites purely mathematic data
manipulation and statistical calculations and thus does not integrate the
recited judicial exception into a practical application.
Finally, claim 1 step (e) recites, “providing said therapeutic
intervention to said individual based on said evaluation.” The claim in Mayo
is similar to the recited claim in that it was directed to using naturally-
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occurring levels of a drug metabolite to determine how much of the drug to
subsequently administer to a patient. Mayo, 566 U.S. at 74–75. This is
analogous to how naturally-occurring genomic markers are correlated in the
rejected claims to a phenotypic attribute and generic treatment in the present
case. As stated by the Court in Mayo, the combination of steps in the claim
“amounts to nothing significantly more than an instruction to doctors to
apply the applicable laws when treating their patients.” Mayo, 566 U.S. at
79. The Court found that steps of the claim “simply tell doctors to gather
data from which they may draw an inference in light of the correlations.” Id.
Here, as in Mayo, rejected claim 1 sets forth a law of nature, namely, a
natural relationship or natural correlation between genotype and phenotype
and an unspecified treatment based on that phenotype. For these reasons, is
not directed to a practical application of an abstract idea.
In summary, steps (a)-(d) of claim 1 recite mental processes; steps (b),
(c) and (d) recite the abstract ideas of mathematical concepts/operations; and
step (e) recites applying a law of nature for a generic treatment, with nothing
more. Accordingly, we conclude that claim 1 recites, and is directed to
multiple judicial exceptions to patentability. Claim 1 is not directed to a
practical application of an abstract idea.
In contrast to DDR and Amdocs, the application of statistical
calculations to the natural phenomenon inherent in genomic material, does
not provide a technical solution to a technical problem, i.e., a “solution . . .
necessarily rooted in computer technology in order to overcome a problem
specifically arising in the realm of computer networks.” DDR, 773 F.3d at
1257. Nor does Appellants’ invention entail, like Amdocs, any
“unconventional technological solution (enhancing data in a distributed
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fashion) to a technological problem (massive record flows which previously
required massive databases)” that “improve[s] the performance of the system
itself.” Amdocs, 841 F.3d at 1300, 1302. Instead, the claimed method
applies statistical calculations to evaluate a natural phenomenon relating to
genomic material and does not to improve any underlying technology or
provide a solution to any technological problem.
For these reasons, we agree with the Examiner’s determination that
Appellants’ claim 1 is directed to an abstract idea, mental processes, and
data manipulation, that find that this judicially excepted subject matter is not
integrated into a practical application.
Alice/Mayo—Step 2 (Inventive Concept)
Step 2B identified in the Revised Guidance
Under the 2019 Revised Guidance, only if a claim: (1) recites a
judicial exception, and (2) does not integrate that exception into a practical
application, do we then look to whether the claim adds a specific limitation
beyond the judicial exception that is not “well-understood, routine,
conventional” in the field (see MPEP § 2106.05(d)); or, simply appends
well-understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception.
See 2019 Revised Guidance, 84 Fed. Reg. at 56.
The Examiner found that providing a generic therapeutic intervention
to an individual, was a routine clinical practice, and was well known, routine
and conventional. Final Act. 7.
In particular, the Examiner found that
The additional [claim] elements are conventional. Cooper
et al. (Nucleic Acids Research Vol. 26, pages 285-287 (1998)
cited in the Information Disclosure Statement received 27
October 2015) provides evidence that generating a database of
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mutations with at least 1,000 genomic markers of relevance to
human phenotypes is conventional by showing a prior art
database that relates genotypes and phenotypes. Cooper et al.
shows in Table 1 that the database has 11.972 different
mutations in the database. Vogelstein et al. (Proceedings of the
National Academy of Sciences USA Vol. 96, pages 9236-9241
(1999)) provides evidence that assaying genomic markers in a
human genome by amplification is conventional. Vogelstein et
al. shows a polymerase chain reaction procedure that detects
mutations in a sample in figures 2-5 and Table 1. Shi (Clinical
Chemistry Vol. 4 7, pages 164-172 (2001)) reviews methods of
detecting mutations, and shows on page 166 that sequencing
may be used to detect mutations in a sample. The additional
elements do not comprise an inventive concept when
considered individually or as an ordered combination that
transforms the claimed judicial exception into a patent-eligible
application of the judicial exception.

Final Act. 7
Appellants rely on the Declaration of Dr. Reese4 to show that the
claimed method includes elements that are not routine and conventional.
App. Br. 21. Dr. Reese states that:
At the time of the claimed invention, rapid advances in
sequencing technology were vastly increasing the amount of
sequencing data available for analysis. This increase created a
number of obstacles that were addressed using the multivariate
scoring matrix of the claimed invention. Examples of such
improvements are outlined below.
The multivariate scoring matrix of the claimed invention
allows for the rapid evaluation of multiple phenotype risks, as
the entire genotypic dataset may only need to be evaluated a
single time to determine risks for all evaluated phenotypes.

4 Declaration of Martin D. Reese, Ph.D., pursuant to 37 C.F.R. § 1.132 dated
June 29, 2016 (“Reese Declaration”).
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Reese Declaration ¶¶ 6, 7. Appellants contend that, in the claimed method
the “analysis uses complex relationships between genotype and phenotype to
provide a many to many analysis of input genotype information, rather than
a mere one-to-one correlation.” App. Br. 12. Appellants further argue that,
the Declaration evidences that,
the method of claim 1 [-] (1) improves upon computer related-
technology by performing a function not previously
performable by a computer (“evaluation that is with respect to a
probability that said individual will exhibit one or more
phenotypic attributes using a multivariate scoring matrix that
relates a plurality of genomic markers with probabilities of
exhibiting phenotypic attributes”), and (2) provides a particular
way to achieve a desired outcome, as opposed to merely
claiming an idea of a solution or outcome.
Id. at 13–14. Appellants argue that:
As in McRO, … claim 1 sets forth detailed limitations
that define a way to produce an outcome (e.g., determining a
probability that an individual will exhibit said one or more
phenotypic attributes to yield said evaluation and providing a
therapeutic intervention based on the evaluation) without
claiming all methods of doing so.
Id. at 18.
We disagree because Appellants have not shown that the claims on
appeal add a specific limitation beyond the judicial exception that is not
well-understood, routine, and conventional in the field. See MPEP
§ 2106.05(d). As the Federal Circuit explained “after Alice, there can
remain no doubt: recitation of generic computer limitations does not make
an otherwise ineligible claim patent-eligible.” DDR, 773 F.3d at 1256
(citing Alice, 573 U.S. at 223).
Appellants have not identified any additional element recited in
Appellants’ claims that is not well-understood, routine, and conventional to
Appeal 2018-006646
Application 14/879,912

20

a skilled artisan. The law is clear that the claim element to be considered
under Alice step 2 cannot be the abstract idea itself. Berkheimer v. HP Inc.,
890 F.3d 1369, 1374 (Fed. Cir. 2018) (Moore, J., concurring) (“Berkheimer
. . . leave[s] untouched the numerous cases from [the Federal Circuit] which
have held claims ineligible because the only alleged ‘inventive concept’ is
the abstract idea.”); BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1283
(Fed. Cir. 2018) (indicating same). “Groundbreaking, innovative, or even
brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for
Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013) (
emphasis added).
For these reasons, we conclude, under the 2019 Revised Guidance,
that each of Appellants’ claims, when considered as a whole, are directed to
a patent-ineligible abstract idea that is not integrated into a practical
application, and is not directed to an inventive concept.

DECISION
The Examiner’s rejection of the claims as directed to an abstract idea
or law of nature under 35 U.S.C. § 101 is AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED