Blum, Kenneth

Patent Trials and Appeals Board

Apr 20, 2020

14863503 - (D) (P.T.A.B. Apr. 20, 2020)

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.
14/863,503 09/24/2015 Kenneth Blum 072191-20003 3226
35161 7590 04/20/2020
DICKINSON WRIGHT PLLC
1825 EYE ST., NW
SUITE 900
WASHINGTON, DC 20006
EXAMINER
SITTON, JEHANNE SOUAYA
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
04/20/2020 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):
dwpatents@dickinsonwright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENNETH BLUM
Appeal 2019-0039291
Application 14/863,503
Technology Center 1600

Before DONALD E. ADAMS, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

HARDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of detecting the presence of one or more particular alleles in a
biological sample. The Examiner rejected the claims as being directed to
patent-ineligible subject matter under 35 U.S.C. § 101, and as obvious under
35 U.S.C. § 103. 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 Igene
LLC. Appeal Br. 4.
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CLAIMED SUBJECT MATTER
According to the Specification, “[t]he present invention satisfies the
need to classify patients at genetic risk for drug/alcohol seeking behavior
prior to or upon entry to residential and or non-residential chemical
dependency and pain programs.” Spec. ¶ 11. Disclosed methods involve
determining the presence of particular alleles in a tested subject. Id. The
Specification states:
Utilization of the genetic addictive risk analysis test in
clinical practice should: (1) reduce denial; (2) reduce guilt; (3)
reduce erroneous - prediction of relapse chance; (4) lead to
appropriate therapeutic targets based on known gene
polymorphisms and medication dosing; (5) improve drug
selection and evaluation; (6) analyze patient risk for pain
medication tolerance, dependence, and/or abuse; and (7)
improve outcomes based on medical necessity.
Id. ¶ 99.
Claims 12 and 20–38 are on appeal. Final Act. 1. The claims are
directed to a method of detecting the presence of one or more alleles in a
biological sample. Appellant’s only independent claim, claim 12, is
illustrative and reproduced below:
12. A method comprising the steps of:
(i) obtaining a biological sample from a subject; and
(ii) detecting whether one or more alleles in a pre-
determined plurality of alleles is present in the biological
sample, wherein the step of detecting whether one or more of
the alleles in the predetermined plurality of alleles are present
comprises
(a) detecting whether one or more of allele G of gene
DRD1 are present in the biological sample;
(b) detecting whether one or more of allele A1 of gene
DRD2 are present in the biological sample;
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(c) detecting whether one or more of allele C of gene
DRD3 are present in the biological sample;
(d) detecting whether one or more of allele C of gene
DRD4 are present in the biological sample;
(e) detecting whether one or more of allele 9R of gene
DAT1 are present in the biological sample;
(f) detecting whether one or more of allele 7-11R of
gene DRD4 are present in the biological sample;
(g) detecting whether one or more of allele S or L of
gene HTTLPR are present in the biological
sample;
(h) detecting whether one or more of allele 4R of gene
MAOA are present in the biological sample;
(i) detecting whether one or more of allele G of gene
COMT are present in the biological sample;
(j) detecting whether one or more of allele G of gene
OPRM1 are present in the biological sample;
(k) detecting whether one or more of allele 181 of
gene GABRB3 are present in the biological
sample.
Appeal Br. 48–49 (Claims Appendix).
Several dependent claims recite additional steps of diagnosing the
subject with a predisposition to reward deficiency syndrome2 based on
detecting specific alleles, and the administration of treatment based on that
diagnosis. Claim 21, reproduced below, is representative of such dependent
claims:
21. The method of Claim 12 further comprising:
(i) diagnosing the subject with a predisposition to reward
deficiency syndrome when at least seven alleles in the

2 According to the Specification, reward deficiency syndromes include
alcohol abuse and drug abuse. Spec. ¶ 33.
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predetermined plurality of alleles were detected to be
present in the step of detecting whether one or more of
the alleles in the predetermined plurality of alleles are
present, wherein the reward deficiency syndrome
comprises alcohol abuse, and
(ii) administering treatment to the diagnosed subject,
wherein the treatment comprises entry of the diagnosed
subject in a residential alcohol dependency program and
medically monitoring alcohol use by the diagnosed
subject.
Appeal Br. 50 (Claims Appendix).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Blum III US 2011/0189161 A1 Aug. 4, 2011
Blum I US 2012/0053070 A1 Mar. 1, 2012
Batel et al., A Haplotype of the DRD1 Gene Is Associated With Alcohol
Dependence, 22 Alcoholism: Clinical and Experimental Research 567–
572 (2008) (“Batel”)
Blum et al., Genetic Addiction Risk Score (GARS): Testing For
Polygenetic Predisposition and Risk to Reward Deficiency Syndrome
(RDS), in Gene Therapy Applications 327–362 (Prof. Chunsheng Kang
ed. 2011) (“Blum II”)
AL-Eitan et al., Custom genotyping for substance addiction susceptibility
genes in Jordanians of Arab descent, 5 BMC Res. Notes 497–507 (“AL-
Eitan”)
REJECTIONS
Claims 12 and 20–38 stand rejected under 35 U.S.C. § 101 as directed
to patent-ineligible subject matter. Final Act. 3.
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Claims 12, 21–32, and 38 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Blum I, Blum II, Blum III, Batel, and AL-Eitan.3
Final Act. 8; Ans. 7, 10.
OPINION
We have considered those arguments made by Appellant in the
Appeal Brief and properly presented in the Reply Brief; arguments not so
presented in Appellant’s briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv)
(2015); see also Ex parte Borden IV, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) (“Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.”).
Subject Matter Eligibility
A. Principles of Law
1. 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.

3 Although the Examiner listed claims 33–37 as subject to the rejection
under 35 U.S.C. § 103 in the Final Action, the Examiner later withdrew
these claims from that rejection. See Ans. 10.

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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 what concept the claim is “directed to.” See Alice, 573 U.S. at
219.
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 (quotation marks omitted). A
claim that recites a law of nature must include “additional features that
provide practical assurance that the process is more than a drafting effort
designed to monopolize the law of nature itself.” Mayo, 566 U.S. at 77. “A
patent, for example, [cannot] simply recite a law of nature and then add the
instruction ‘apply the law.’” Id. at 77–78.
2. 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”).4 “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.

4 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the Guidance. USPTO, October
2019 Update: Subject Matter Eligibility (“October 2019 Update”) (available
at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
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Under the Guidance and the October 2019 Update, we first look to
whether the claim recites:
(1) any judicial exceptions, including laws of nature,
natural phenomena, and certain groupings of abstract ideas
(“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”).5
Guidance, 84 Fed. Reg. at 51–55.
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.
B. Analysis
For purposes of responding to the § 101 rejection, Appellant argues
the claims in two groups, with the first group consisting of claims 12 and 20
(with claim 12 being representative), and the second group consisting of

5 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 Guidance - Section III(A)(2), 84 Fed. Reg. at 54–
55.
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claims 21–38 (with claim 21 being representative). See, e.g., Appeal Br. 27
(“the § 101 inquiry for Claim 20 is th[e] same as that for Claim 12”), id.
(“Claim 21 is representative of” the grouping of claims 21–38), 36 (“Claim
21 . . . is representative of each of Claim[s] 22–38”). Accordingly, we focus
our § 101 analysis on representative claims 12 and 21.
1. Claim 12
a. Guidance Step 2A, Prong 1
Pursuant to the Guidance, we begin by determining whether claim 12
recites any judicial exception(s) to patent eligibility. Guidance, 84 Fed. Reg.
at 54.
Claim 12 comprises the steps of “obtaining a biological sample from a
subject” and “detecting whether one or more alleles in a pre-determined
plurality of alleles is present in the biological sample.” Appeal Br. 48
(Claims Appendix). The Examiner found that claim 12 recites multiple
judicial exceptions, i.e., a law of nature/natural phenomenon and a mental
process: “[A]ny association between the alleles listed in the claims and
reward deficiency syndrome is a law of nature/natural phenomenon. . . .
[T]he detecting step is an action tha[t] can be performed mentally.” Final
Act. 4; see also Ans. 5.
We agree with the Examiner that claim 12 is directed to a natural
phenomenon. Appellant’s claim 12 is similar to the claims held ineligible in
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015)
for being directed to a natural phenomenon. Claim 1 at issue in Ariosa is
illustrative:
1. A method for detecting a paternally inherited nucleic acid of
fetal origin performed on a maternal serum or plasma
sample from a pregnant female, which method comprises
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amplifying a paternally inherited nucleic acid from the
serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid
of fetal origin in the sample.
Id. at 1373–74. This claim recites a method for detecting paternally-
inherited fetal DNA in the blood or serum of a pregnant female. Id. The
Federal Circuit found that the existence and location of the fetal DNA in the
sample is a natural phenomenon, and thus the method begins and ends with a
natural phenomenon. Id. at 1376. As such, the court found that the claim is
directed to naturally occurring matter. Id. Here too, the existence of the
claimed alleles in the biological sample is a natural phenomenon, and thus
the method likewise begins and ends with a natural phenomenon.
Accordingly, claim 12 is directed to matter that is naturally occurring.
Appellant argues that claim 12 is patent-eligible because it parallels
claim 1 of Example 29 in the USPTO’s May 2016 Interim Guidance on
Patent Subject Matter Eligibility (“Interim Guidance”). Appeal Br. 21.
Claim 1 of Example 29 reads:
1. A method of detecting JUL-1 in a patient, said method
comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample
by contacting the plasma sample with an anti-JUL-1
antibody and detecting binding between JUL-1 and the
antibody.
Interim Guidance, Subject Matter Eligibility Examples: Life Sciences, at 10.
We are not persuaded that Appellant’s claim 12 is similar to this
example claim. Unlike Appellant’s claim 12, the example claim includes
steps of contacting the plasma sample with an antibody, and detecting
binding between that antibody and the naturally-occurring protein JUL-1.
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Because the antibody is added to the plasma sample, and because the
detecting step relates to detecting binding between the added antibody and
the naturally-occurring protein, the example claim materially differs from
both the Ariosa claim and Appellant’s claim 12, which lack such steps, and
which merely detect the existence of naturally-occurring genetic material in
a biological sample.
Appellant disputes that the use of the antibody in claim 1 of Example
29 is necessary to a finding of eligibility. Appeal Br. 24–25. In support of
this argument, Appellant asserts that claim 5 of Example 29 recites a
“detecting” step that does not require use of an antibody, and “but for the
additional[] recitations in Claim 5 (steps c and d), the analysis for Claim 5
would have ended at Step 2A, as the first two steps in Claim 5 (steps a and
b) do not recite or describe any recognized judicial exception.” Appeal Br.
25. We are not persuaded by this argument. The Interim Guidance does not
address Appellant’s hypothetical claim, and does not state that but for steps c
and d in Claim 5, the eligibility analysis would have concluded at Step 2A.
In fact, the analysis with respect to Claim 5 states: “Because claim 5 recites
the same correlation and critical thinking step (step c) as claim 2, which as
explained above is a law of nature and/or an abstract idea, the claim is
directed to a judicial exception.” Interim Guidance, Subject Matter
Eligibility Examples: Life Sciences, at 14. As such, we conclude
Appellant’s hypothetical claim analysis would not have ended at Step 2A,
but would have continued on to address whether there were additional
elements beyond the abstract idea that add any meaningful limitation.
Interim Guidance, Subject Matter Eligibility Examples: Life Sciences, at 11–
12.
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Because claim 12 recites at least one judicial exception, i.e., a natural
phenomenon, we proceed to the next inquiry under the Guidance.
b. Guidance Step 2A, Prong 2
Moving to the next inquiry under the Guidance, we find that claim 12
does not integrate the natural phenomenon into a practical application.
Guidance, 84 Fed. Reg. at 54–55. The method begins with obtaining a
biological sample, and ends with detecting one or more alleles in that
sample. The method does not require that any action be taken if the alleles
are detected. Again, like the claims in Ariosa, the method begins and ends
with the natural phenomenon. Ariosa Diagnostics, Inc., 788 F.3d at 1376;
see also Mayo, 566 U.S. at 79–80 (claims ineligible where they “simply tell
doctors to gather data from which they may draw an inference in light of the
correlations”). Accordingly, we conclude that the claim 12 does not
integrate the natural phenomenon into a practical application.
c. Guidance Step 2B
We next determine whether claim 12 adds specific limitation(s)
beyond the judicial exception that are not “well-understood, routine,
conventional activity in the field” (see MPEP § 2106.05(d)), or whether they
simply append well-understood, routine, conventional activities previously
known to the industry, specified at a high level of generality, to the judicial
exception. See Guidance, 84 Fed. Reg. at 56.
“For process claims that encompass natural phenomenon, the process
steps are the additional features that must be new and useful.” Ariosa
Diagnostics, Inc., 788 F.3d at 1377. Here, claim 12 contains no process
steps other than those that enable detection of the natural phenomenon.
Moreover, the Examiner found that both the “obtaining” and “detecting”
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steps in claim 12 “are extremely well understood, routine, and conventional
in the field of genetic analysis.” Final Act. 5; see also id. at 6; see also Spec.
¶ 52 (discussing obtaining saliva samples), ¶¶ 53–58 (discussing known
genotyping assays and methods). We agree with and adopt the Examiner’s
finding.6 See, e.g., Athena Diagnostics, Inc. v. Mayo Collaborative Servs.,
LLC, 915 F.3d 743, 754 (Fed. Cir. 2019) (“Because the specification defines
the individual immunoprecipitation and iodination steps and the overall
radioimmunoassay as conventional techniques, the claims fail to provide an
inventive concept.”).
Thus, claim 12 starts and ends with naturally-occurring
phenomenon—the detection of certain alleles in a biological sample—with
no meaningful non-routine steps in between. Claim 12 is therefore directed
to a natural phenomenon without significantly more. We thus affirm the
rejection of claim 12 under 35 U.S.C. § 101. We also affirm the rejection of
claim 20 for the same reasons. See, e.g., Appeal Br. 27 (conceding that “the
§ 101 inquiry for Claim 20 is th[e] same as that for Claim 12”).
2. Claim 21
a. Guidance Step 2A, Prong 1
Claim 21 depends from claim 12, and thus incorporates the same
natural phenomenon discussed above. Additionally, claim 21 recites the
following “diagnosing” step:
(i) diagnosing the subject with a predisposition to reward
deficiency syndrome when at least seven alleles in the

6 Appellant did not dispute this finding, and in fact did not make any
arguments specific to Step 2B for claim 12, instead arguing that the
eligibility analysis ends with a finding of eligibility at Step 2A. Appeal Br.
23.
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predetermined plurality of alleles were detected to be present in
the step of detecting whether one or more of the alleles in the
predetermined plurality of alleles are present, wherein the
reward deficiency syndrome comprises alcohol abuse
Appeal Br. 50 (Claims Appendix). This limitation recites a law of nature,
i.e., the natural relationship between the specified alleles and a
predisposition to reward deficiency syndrome. See, e.g., Mayo, 566 U.S. at
1296 (relationship between concentrations of metabolites in the blood and
the likelihood that a dosage of drug will be ineffective or cause harm was a
patent-ineligible law of nature); Athena, 915 F.3d at 750 (correlation
between the presence of MuSK autoantibodies in bodily fluid and certain
neurological diseases is an ineligible natural law). Thus we agree with the
Examiner that “any association between the alleles listed in the claims and
reward deficiency syndrome is a law of nature/natural phenomenon, as is the
existence of the alleles themselves.” Final Act. 4. Indeed, Appellant
concedes that this limitation recites a judicial exception. Reply Br. 10 (“[I]n
view of limitation 21(i), prong one of Step 2A is ‘yes’ . . . .”). Thus, we
move to the next step of the Guidance.
a. Guidance Step 2A, Prong 2
We next consider whether the claimed method includes additional
elements that integrate the natural phenomenon and natural law into a
practical application. A claim can integrate a judicial exception into a
practical application by applying or using the judicial exception to effect a
particular treatment or prophylaxis for a disease or medical condition. See,
e.g., October 2019 Update at 13; Vanda Pharm. Inc. v. West-Ward Pharm.
Int’l Ltd., 887 F.3d 1117, 1134–35 (Fed. Cir. 2018) (claims eligible where
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they recite administration of a specific dose of a drug in response to genetic
testing results).
Claim 21 recites the following treatment step:
(ii) administering treatment to the diagnosed subject, wherein the
treatment comprises entry of the diagnosed subject in a
residential alcohol dependency program and medically
monitoring alcohol use by the diagnosed subject.
Appeal Br. 50 (Claims Appendix). This step recites two treatments: entry
of the diagnosed subject in a residential alcohol dependency program, and
medically monitoring alcohol use by the diagnosed subject.
We begin our analysis with the treatment of “medically monitoring
alcohol use by the diagnosed subject.” The Examiner found that this step
“read[s] on nothing more than making observations and conclusions,” and
“appear[s] to be instructions.” Final Act. 5; Ans. 12. We agree with and
adopt the Examiner’s finding.
We note that the Specification uses the term “medical monitoring”
once, stating: “Other benefits include, but are not limited to, determination
of medical monitoring (treatment medication) as a function of different
reward gene polymorphisms.” Spec. ¶ 97. While this statement may
suggest that medical monitoring can encompass administering medication,
on this record, we are unable to equate “medically monitoring” a diagnosed
subject with the administration of any particular medication or any particular
dosing regimen. We further note that claim 32 specifies that “medically
monitoring chemical use by the diagnosed subject comprises
pharmacotherapy.” Although this limitation links “medically monitoring
chemical use” with “pharmacotherapy,” this claim also fails to link medical
monitoring with any particular medication or any particular dosing regimen.
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This lack of specificity stands in contrast to cases where the Federal
Circuit has found particular methods of treatment to be patent eligible. See,
e.g., Endo Pharms. Inc. v. Teva Pharms. USA, Inc., 919 F.3d 1347, 1350–51
(Fed. Cir. 2019) (claims eligible where they rely on a law of nature (the
relationship between oxymorphone and patients with renal impairment) to
identify a patient as requiring a particular treatment (a lower dosage of
oxymorphone), and then administering that particular treatment to the
patient); Natural Alternatives Int’l v. Creative Compounds LLC, 918 F.3d
1338, 1345 (Fed. Cir. 2019) (claims eligible where they rely on natural
relationship but also require administration of certain amounts of specific
compounds “in order to bring about a change in a subject, altering the
subject’s natural state”); Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd.,
887 F.3d 1117, 1134–35 (Fed. Cir. 2018) (claims eligible where they recite
administration of a specific dose of a drug in response to genetic testing
results); cf. October 2019 Update, Appendix 1 at 3–5 (claim 1 of Example
43 is ineligible where it recites judicial exceptions (a mental process and law
of nature), and includes only a “nominal” treatment limitation that does not
require any particular application of the judicial exceptions).
Accordingly, we find that “medically monitoring” fails to
meaningfully limit the claim, because such monitoring 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, including no treatment at all (mere monitoring). This limitation
at most tells doctors to take the natural law into account when treating their
patients, akin to merely adding the words “apply it” to the judicial exception.
Mayo, 566 U.S. at 72 (“To transform an unpatentable law of nature into a
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patent-eligible application of such a law, one must do more than simply state
the law of nature while adding the words ‘apply it.’”).
We now turn to the treatment of “entry of the diagnosed subject in a
residential alcohol dependency program.” We find that this limitation
similarly fails to transform the recited judicial exceptions into a patent-
eligible application. Neither the claims nor the Specification elaborate on
specific treatments that are provided in the claimed residential alcohol
dependency program, and on this record, Appellant has not directed us to
any evidence that such programs require any particular intervention, such as
a particular medication used in a particular dosing regimen. Indeed, entry
into a residential alcohol dependency program may simply be for purposes
of monitoring the patient. As discussed above, mere monitoring fails to
transform an unpatentable law of nature into a patent-eligible application of
that law.
For the above reasons, we determine that claim 21 does not integrate
the judicial exceptions into a practical application, and is therefore directed
to the judicial exceptions itself.
b. Guidance Step 2B
Proceeding to Guidance Step 2B, we agree with the Examiner that the
elements of claim 21, considered both individually and in combination, do
not provide an inventive concept beyond the judicial exception itself. Final
Act. 4–6. Aside from the obtaining, detecting, and diagnosing steps, the
remaining claim step is the “administering treatment” step, which again,
recites two treatments: entry of the diagnosed subject in a residential
alcohol dependency program, and medically monitoring alcohol use by the
diagnosed subject. The Examiner found, and we agree, that each of these
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steps, individually and in combination, is well known, routine, and
conventional activity in the field of substance abuse treatments. Final Act.
5, 7; Ans. 6, 11–12; see also Spec. ¶ 52 (discussing obtaining saliva
samples), ¶¶ 53–58 (discussing known genotyping assays and methods);
Blum II at 336, 349–50, 353 (teaching evaluation of multiple alleles to
assess genetic risk for reward deficiency predisposition in connection with
entry to residential treatment program and to understand need for medical
therapies).
Appellant argues that claim 21 parallels claims 5 and 6 of Example 29
of the Interim Guidance, which claims were deemed patent eligible. Appeal
Br. 28–31, 33. We are not persuaded by this argument, because Appellant
does not persuasively identify any specific parallels between claim 21 and
claims 5 and 6 of Example 29. Indeed, we see no parallel. Both claims 5
and 6 of Example 29 recite specific treatments involving specific drugs, i.e.,
administering an effective amount of topical vitamin D (claim 5) or anti-
tumor necrosis factor (TNF) antibodies (claim 6) to the diagnosed patient.
Interim Guidance, Subject Matter Eligibility Examples: Life Sciences, at
10–11. The specificity of these treatments stands in contrast to the generic
treatments recited in Appellant’s claim 21.
Accordingly, we affirm the rejection of claim 21 as patent-ineligible
under 35 U.S.C. § 101. Appellant did not separately argue claims 22–28.
Rather, in the Appeal Brief, Appellant listed the unique limitations of these
claims, but did not offer any arguments specific to those limitations. See
Appeal Br. 35–36. “A statement which merely points out what a claim
recites will not be considered an argument for separate patentability of the
claim.” 37 C.F.R. § 41.37(c)(1)(iv). Moreover, Appellant characterized
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claim 21 as representative of claims 22–38, and argued that these claims are
eligible “for similar reasons as for Claim 21.” Appeal Br. 36; see also id. at
27 (“Claim 21 is representative of” the grouping of claims 21–38); Reply Br.
11–12. Accordingly, for the same reasons discussed above with respect to
claim 21, we affirm the rejection of claims 22–38 as patent-ineligible under
35 U.S.C. § 101.
Obviousness
As to the rejection of claims 12, 21–32, and 38 as obvious, the
Examiner found that “Blum I, II, and III, Batel, and AL-Eitan each teach
performing genetic analysis on a number of different genes for
polymorphisms associated with addiction.” Final Act. 8; see also id. 8–9
(specifying which references teach which of the claimed alleles). The
Examiner found that it was routine in the art to select optimal combinations
of polymorphisms for association with addiction, and that a skilled artisan
would have been motivated to include the claimed polymorphisms in a
genotype analysis, because the cited combination of prior art teaches that
these polymorphisms are associated with addiction. Id. at 10. The Examiner
also found that it would have been obvious to treat subjects diagnosed with a
reward deficiency syndrome, including by use of in-patient residential
programs, monitoring patients, and providing dopamine regulators, as taught
in Blum II. Id. The Examiner additionally found that it would have been
obvious to avoid opioid pain medication in patients with opioid dependency,
and alternatively use NSAIDs, because such treatment strategies were
known and used. Id.
We agree with and adopt the Examiner’s findings of fact on the
obviousness of claims 12, 21–32, and 38, and determine that the Examiner
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has presented a prima facie case of obviousness with respect to these claims.
We address Appellant’s arguments below.
Appellant argues that the Examiner has impermissibly used
Appellant’s claim 12 as a template to pick and choose elements from five
different prior art references, because while claim 12 recites the detection of
eleven specific alleles, the prior art reflects a “potpourri of genes and a
variety of alleles for many of these genes.” Appeal Br. 40–41; see also id. at
43 (discussing the many other genes and alleles disclosed in the cited prior
art combination); Reply Br. 13–14. Appellant further argues that the
Examiner has not established a legitimate motivation for why a skilled
artisan “would have sifted through the incredible number of combinations
and permutations in the cited art, to have selected a determination step that
includes each of the eleven recited detection sub-steps of limitations
12(ii)(a)-(k).” Appeal Br. 42; see also id. at 43–44. Appellant also argues
that despite the fact that claim 12 uses the open-ended transitional phrase
“comprising,”
given the vast expanse of alleles and genes disclosed in Blum I,
Blum II, Blum III, Batel 2008, and Al-Eitan 2012, and the fact
that a person of ordinary skill in the art would have limited the
number of detection of alleles and genes to a reasonable and
useable number, based upon the number of combinations and
permutations alone, it is hardly obvious that a person of
ordinary skill would have come up with any combination to
detect particularly identified alleles of the specifically identified
genes set forth in limitations 12(ii)(a)-(k).
Id. at 44–45; see also Reply Br. 13–14.
We are not persuaded by Appellant’s arguments. We find that the
Examiner’s prima facie case is appropriately grounded in the teachings of
the prior art. Claim 12 recites the detection of eleven specific alleles, more
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than half of which are taught in Blum I. See Final Act. 9 (citing Blum I
¶¶ 73–80). Blum I also teaches that additional genes, including DRD1,
OPRMI, GABRB3, and DRD3 (each of which is recited in claim 12), are
involved in various reward dependence pathways. See Blum I ¶ 12 (Table
1). Blum II, Blum III, Batel, and AL-Eitan each teach that the specific
alleles on these genes recited in claim 12 are prevalent in alcohol and drug
dependence disorders. See Final Act. 9. Additionally, Blum II teaches that
reward deficiency syndrome involves multiple genes and many
polymorphisms, and likely requires a threshold number of reward deficiency
syndrome-associated polymorphisms to manifest in a particular subject. Id.
at 11 (citing Blum II 336, 354 (Table 7)). Based on these teachings, we
agree with the Examiner that a skilled artisan would have been motivated to
include the polymorphisms set forth in claim 12 in a method of genotype
analysis, because the cited prior art combination teaches that these
polymorphisms are associated with addiction.
We find nothing inventive in listing out this specific combination of
alleles in claim 12, because each allele was already taught to be associated
with addiction. Moreover, claim 12 uses the open-ended transition term
“comprising,” which means that the claimed method can be practiced even if
a skilled artisan detected many additional alleles in the biological sample.
See, e.g., Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed.
Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the
claim is open-ended and allows for additional steps.”). That is, the recitation
of detecting the presence of the eleven recited alleles does not preclude
detecting the presence of any of the multitude of other alleles taught in the
cited prior art combination to be associated with addiction. See also In re
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Mercier, 515 F.2d 1161, 1165 (CCPA 1975) (“[A]ll of the relevant teachings
of the cited references must be considered in determining what they fairly
teach to one having ordinary skill in the art.”). Moreover, we are not
persuaded by Appellant’s assertion that a person of ordinary skill in the art
“would have limited the number of detection of alleles and genes to a
reasonable and usable number” (Appeal Br. 44) because Appellant has not
pointed us to evidence supporting this assertion, nor has Appellant pointed
us to evidence identifying what a “reasonable and usable number” would be.
See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (noting
that attorney argument is “no substitute for evidence”).
Appellant also argues that the cited prior art includes “statements that
conflict with the selection of [the] eleven sets of particular alleles” recited in
claim 12. Appeal Br. 42–43; see also id. at 45 (referencing but not
identifying “teachings in the prior art that point away to [sic] some of the
limitations 12(ii)(a)-(k)”). We are not persuaded by this argument, because
with one exception, Appellant fails to point us to any such statement or
teaching. Appellant does cite a statement in Blum I which teaches that allele
A of the COMT gene was found to be much higher in heroin addicts than in
controls, whereas claim 12 recites detection of allele G of this gene. Id. at
43 (citing Blum I ¶ 77). We agree with the Examiner that this argument is
not persuasive because claim 12 only requires detecting “whether” allele G
of COMT is present. Final Act. 13. If allele A is detected, the requirement
of “detecting whether one or more of allele G of gene COMT are present in
the biological sample” would be met. Id.
Appellant additionally argues that the cited prior art combination does
not teach the additional limitations recited in claim 21, i.e., the requirements
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of diagnosing a subject with alcohol abuse when at least seven of the recited
alleles are detected, and administering specific treatments to the diagnosed
subject (entry into a residential program and medically monitoring alcohol
use). Appeal Br. 45. We are not persuaded by this argument. We agree
with the Examiner that Blum II teaches that testing for multiple
polymorphisms can be used to determine stratified genetic risk of patients
with addictive behaviors, and suggests using such genetic testing to classify
risk behavior in patients seeking in-patient residential treatment (where
patients are monitored). Final Act. 8; Blum II 336, 349–50, 353.
For the above reasons, we affirm the rejection of claims 12 and 21 as
obvious. Appellant asserts that claim 21 is representative of claims 21–32
and 38 with respect to the obviousness rejection. Appeal Br. 45; Reply Br.
2, 3. Accordingly, for the same reasons discussed above with respect to
claim 21, we also affirm the obviousness rejection of claims 22–32 and 38.
CONCLUSION
We affirm the rejection of claims 12 and 20–38 under 35 U.S.C. § 101
as directed to patent-ineligible subject matter.
We affirm the rejection of claims 12, 21–32, and 38 under 35 U.S.C.
§ 103 as being unpatentable over Blum I, Blum II, Blum III, Batel, and AL-
Eitan.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
12, 20–38 101 Eligibility 12, 20–38
12, 21–32,
38
103 Blum I, Blum II, Blum
III, Batel, AL-Eitan
12, 21–32,
38

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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
Overall
Outcome
12, 20–38

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