Soykan, Orhan et al.

Patent Trials and Appeals Board

Sep 16, 2019

14698812 - (D) (P.T.A.B. Sep. 16, 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.
14/698,812 04/28/2015 Orhan Soykan C00007108.USU3_10021.US 1654
148129 7590 09/16/2019
Hahn&Associates-Medtronic CRDM
Hahn&Associates-Medtronic CRDM
1012 14th Street, NW Suite 620
Washington, DC 20005
EXAMINER
SITTON, JEHANNE SOUAYA
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
09/16/2019 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):
roger.hahn@hvpatentlaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ORHAN SOYKAN, TARA NAHEY, and
JEFFREY LANDE1
__________

Appeal 2019-004078
Application 14/698,812
Technology Center 1600
__________

Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and DAVID COTTA,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134(a) involving claims to a
diagnostic kit, which have been rejected as being directed to patent-
ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification describes a study intended “to determine whether
any of seven single nucleotide polymorphisms (SNP) in three genes coding

1 Appellant identifies the Real Party in Interest as Medtronic plc. Appeal
Br. 3.
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for G-protein subunits were predictive of ventricular tachyarrhythmias (VT)
in patients with implantable cardioverter defibrillators (ICD) without a prior
history of VT.” Spec. ¶ 138. “Two SNPs in the GNAS gene, C393T and
C2273T, were significant univariate predictors of VT incidence.” Id. ¶ 154.
The Specification’s SEQ ID NOs 1 and 2 correspond to the loci of the
C393T and C2273T SNPs, respectively. Id. ¶ 13.
Claims 1–6, 8–12, and 21 are on appeal. Claim 1 is representative and
reads as follows:
1. A diagnostic kit, comprising:
a processor; and
at least one probe for assessing the presence of one or more Single
Nucleotide Polymorphisms (SNPs) associated with any one of Sudden
Cardiac Arrest (SCA), Sudden Cardiac Death (SCD), Ventricular
Arrhythmia (VA), or Heart Failure (HF) in a genetic sample,
wherein the SNP is contained in any one of the nucleotide sequences
of SEQ ID NO.’s 1–2; and
wherein the assessment by the probe determines whether to apply
treatment to SCA, SCD, VA or HF, the treatment comprising at least one of
a combination CRT pacemaker having defibrillation technology (CRT-D),
an Implantable Cardioverter Defibrillator (ICD), pharmacological therapy,
and biological therapy; and
wherein the processor is programmed to determine whether to implant
the CRT-D or ICD to treat the SCA, SCD, VA or HF based on the
assessment, and
wherein the at least one probe is affixed to a substrate;
the diagnostic kit for determining an increased risk of Ventricular
tachycardia (VT) and ventricular fibrillation (VF) with the treatment based
on the presence of the one or more SNPs comprising at least one of a TT
genotype in SEQ ID NO. 1 and a TT genotype in SEQ ID NO. 2.

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The claims stand rejected as follows:
Claims 1–6, 8–12, and 21 under 35 U.S.C. § 112(b) as indefinite
(Ans. 6) and
Claims 1–6, 8–12, and 21 under 35 U.S.C. § 101 as being directed to
patent-ineligible subject matter (Ans. 3).
I
The Examiner has rejected claims 1–6, 8–12, and 21 as indefinite, on
the basis that claim 1 “recites run on sentences and phrases that do not make
clear how the limitations structurally limit the kit being claimed. For
example, it is not clear how the last phrase after . . . ‘affixed to a substrate’
structurally limits the claim.” Ans. 7.
Appellant argues that,
[a]s described in the Specification, patients with a TT genotype
in either SEQ ID NO. 1 or SEQ ID. NO. 2 are at an increased
risk of VT or VF. See Specification at paragraph [0164]. The
diagnostic kit, by determining the presence of the recited
genotypes in a patient, can be used to determine the increased
risk of VT or VF, and whether or not to apply the recited
treatments. Id.
Appeal Br. 13.
We conclude that the Examiner has not shown that the scope of the
claims would have been unclear to those of ordinary skill in the art. The
claim language that the Examiner points to reads: “the diagnostic kit for
determining an increased risk of Ventricular tachycardia (VT) and
ventricular fibrillation (VF) with the treatment based on the presence of the
one or more SNPs comprising at least one of a TT genotype in SEQ ID NO.
1 and a TT genotype in SEQ ID NO. 2.” Claim 1.
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This limitation specifies that the “probe for assessing the presence of
one or more Single Nucleotide Polymorphisms (SNPs),” previously recited
in the claim, detects the presence of a TT genotype in SEQ ID NO. 1 or a TT
genotype in SEQ ID NO. 2, or both. Thus, the disputed limitation
structurally limits the probe that is part of the claimed kit, and does not make
the claim indefinite. The rejection under 35 U.S.C. § 112(b) is reversed.
II
The Examiner has rejected claims 1–6, 8–12, and 21 under 35 U.S.C.
§ 101. The Examiner finds that “[t]he claims are directed to multiple judicial
exceptions. With regard to the processor, the claim describes the abstract
idea of making a treatment determination.” Ans. 4. The Examiner notes that
the claims include the additional elements of “a ‘diagnostic’ kit, as well as
nucleic acid probes,” but “packaging processors and probes in kit format
was well understood, routine, and conventional in the field as was the use of
probes, including those affixed to substrates, for genetic analysis. The
polymorphisms in the claims are not new, and genetic tests already existed
prior to the effective filing date.” Id. at 5.
The Examiner concludes that these “additional elements alone, and in
combination, do not add significantly more to the abstract idea since they do
not structurally or functionally change the processor and are directed to
routine and conventional activity.” Id. The Examiner also concludes that
“[t]he additional recitation of ‘wherein the at least one probe . . . for
determining an increased risk of . . . VT . . . with the treatment based on the
presence of the one or more SNPs’, is itself merely describing a natural
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correlation between the alleles of the SNP, increased risk of VT and VF, and
treatment outcome which is also a judicial exception.” Id. at 6.
Appellant argues that “Claim 1 recites a processor that makes a
treatment decision . . . [which is] the application of human actions to treat a
patient, which is in no way a law of nature.” Appeal Br. 11. Appellant also
argues that “[p]rior to the invention, it was neither routine nor conventional
to make any treatment decisions based on the TT genotypes for a patient.”
Id. at 8–9. Finally, Appellant argues that “Claim 1 is confined to a specific
embodiment of a diagnostic kit, and does not seek to preempt any other use
of the correlation between the recited genotypes and an increased risk of VT
or VF.” Id. at 11.
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 Supreme Court has concluded that “[l]aws of nature, natural
phenomena, and abstract ideas” are not patentable under 35 U.S.C. § 101.
See, e.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014).
To determine if a claim falls into an excluded category, we apply a
two-step 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)). We first determine what the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging.”).
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Patent-ineligible abstract ideas 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, 69 (1972)). In contrast, patent-eligible inventions include
physical and chemical processes, such as “molding rubber products”
(Diamond v. Diehr, 450 U.S. 175, 192 (1981)); “tanning, dyeing, making
water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7
(quoting Corning v. Burden, 56 U.S. 252, 267–68 (1854))); and
manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94
U.S. 780, 785 (1876))).
In Diehr, the claimed method employed a mathematical formula, but
the Supreme Court held that “[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 176; see also id. at 191 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). The
Supreme Court noted, however, that a claim “seeking patent protection for
that formula in the abstract . . . is not accorded the protection of our patent
laws, . . . and this principle cannot be circumvented by attempting to limit
the use of the formula to a particular technological environment.” Id. (citing
Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an
application of a law of nature or mathematical formula to a known structure
or process may well be deserving of patent protection.”).
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If the claim is “directed to” an abstract idea, we turn to the second
step of the Alice and Mayo framework, and “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.
(quoting Mayo, 566 U.S. at 77 (alterations in original)). “[M]erely
requir[ing] generic computer implementation[] fail[s] to transform that
abstract idea into a patent-eligible invention.” Id.
The PTO recently published revised guidance on the application of
§ 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (January 7, 2019) (“Revised Guidance”). Under that guidance, we
first determine 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); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
See 84 Fed. Reg. at 54–55. Only if a claim (1) recites a judicial exception and
(2) does not integrate that exception into a practical application, do we then
determine whether the claim:
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(3) adds a specific limitation beyond the judicial exception that is not
a “well-understood, routine, conventional activity” 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.
See 84 Fed. Reg. at 56.
Revised Guidance Step 2(A), Prong 1
Following the Revised Guidance, we first consider whether the claims
recite a judicial exception. Claim 1 recites, among other elements, “the
processor is programmed to determine whether to implant the CRT-D or
ICD to treat the SCA, SCD, VA or HF based on the assessment”; i.e., “the
assessment by the probe [that] determines whether to apply treatment.” We
agree with the Examiner that this claim language “describes the abstract idea
of making a treatment determination.” Ans. 4. This determination can be
performed mentally, for example by a person observing whether a probe
specific to a TT genotype in SEQ ID NO: 1 or SEQ ID NO: 2 hybridizes to
DNA in a genetic sample.
In addition, we agree with the Examiner that claim 1 “describ[es] a
natural correlation between the alleles of the SNP, increased risk of VT and
VF, and treatment outcome which is also a judicial exception.” Ans. 6. The
Specification states that “[t]he two SNPs were associated with an increased
risk of VT.” Spec. ¶ 183. The Specification also states that “[t]he GNAS
SNPs described herein (e.g., SEQ ID No.’s 1 and 2) can affect the
expression level of the GNAS protein, which in turn can affect the efficacy
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of cardiac resynchronization therapy (CRT), generally. . . . [T]he SNPs
described herein may be predictors of the efficacy of CRT and/or ICD
therapy.” Id. ¶ 158.
In Mayo, the Court held that “Prometheus’ patents set forth laws of
nature—namely, relationships between concentrations of certain metabolites
in the blood and the likelihood that a dosage of a thiopurine drug will prove
ineffective or cause harm.” 566 U.S. at 77. Similarly here, the recitation in
claim 1 of “determining an increased risk of Ventricular tachycardia (VT)
and ventricular fibrillation (VF) with the treatment based on the presence of
the one or more SNPs comprising at least one of a TT genotype in SEQ ID
NO. 1 and a TT genotype in SEQ ID NO. 2” sets forth a law of nature—the
natural correlation between the recited SNPs and an increased risk of VT or
VF.
In summary, we agree with the Examiner that claim 1 recites an
abstract idea—the mental step of “determin[ing] whether to implant the
CRT-D or ICD to treat the SCA, SCD, VA or HF based on [a probe’s]
assessment”—as well as a law of nature—the correlation between a TT
genotype in SEQ ID NO: 1 or SEQ ID NO: 2 and an increased likelihood of
ventricular arrhythmia. See 84 Fed. Reg. at 52.
Revised Guidance Step 2(A), Prong 2
Although claim 1 recites an abstract idea, it would still be patent-
eligible if “the claim as a whole integrates the recited judicial exception into
a practical application of the exception”; i.e., if the claim “appl[ies], rel[ies]
on, or use[s] the judicial exception in a manner that imposes a meaningful
limit on the judicial exception.” 84 Fed. Reg. at 54. The analysis of
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determining whether the claim integrates the judicial exception into a
practical application includes “[i]dentifying whether there are any additional
elements recited in the claim beyond the judicial exception(s)” and
“evaluating those additional elements individually and in combination to
determine whether they integrate the exception into a practical application.”
Id. at 54–55.
The “examples in which a judicial exception has not been integrated
into a practical application” include “[a]n additional element . . . [that]
merely includes instructions to implement an abstract idea on a computer, or
merely uses a computer as a tool to perform an abstract idea” and “an
additional element [that] adds insignificant extra-solution activity,” such as
mere data-gathering, to the judicial exception. Id. at 55.
Here, claim 1 does not integrate the recited abstract idea and law of
nature into a practical application, because the claimed kit consists of only
two components: a processor and a probe affixed to a substrate. The claim
itself does not specify any hardware or software configuration that is
required for the processor to carry out the recited function. Consistent with
claim language, the Specification broadly defines the term “processor,”
Spec. ¶ 89, and does not provide any more specific description of a
processor as recited in claim 1. “[T]he mere recitation of a generic computer
cannot transform a patent-ineligible abstract idea into a patent-eligible
invention.” Alice, 573 U.S. at 223.
Claim 1 also does not require any specific structure for the
immobilized probe recited in the claims. Rather, the claims require only a
“probe for assessing the presence of one or more Single Nucleotide
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Polymorphisms (SNPs),” “wherein the SNP is contained in any one of the
nucleotide sequences of SEQ ID NO.’s 1–2,” and “the one or more SNPs
compris[e] at least one of a TT genotype in SEQ ID NO. 1 and a TT
genotype in SEQ ID NO. 2.”
That is, claim 1 simply requires any probe that determines the
presence or absence of one of the SNPs that correlates with an increased risk
of VT or VF. The probe is therefore required in order to carry out the data-
gathering needed to apply the natural law recited in the claim: the natural
correlation between the recited SNPs and an increased risk of VT or VF.
The upshot is that the probe recited in claim 1 simply allows the kit to
be used to gather data from which to draw an inference in light of the
correlation between the SNPs and the risk of VT or VF. Cf. Mayo, 566 U.S.
at 79 (“The upshot is that the three steps simply tell doctors to gather data
from which they may draw an inference in light of the correlations.”).
In summary, claim 1 recites an abstract idea and a law of nature and
does not integrate them into a practical application. It is therefore directed to
a judicial exception to patentability.
Revised Guidance Step 2(B)
Finally, the Revised Guidance directs us to consider whether claim 1
includes “additional elements . . . [that] provide[] ‘significantly more’ than
the recited judicial exception.” 84 Fed. Reg. at 56. The Revised Guidance
states that an additional element that “simply appends well-understood,
routine, conventional activities previously known in the industry, specified
at a high level of generality, to the judicial exception, . . . is indicative that
an inventive concept may not be present.” Id.
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Here, the only elements recited in claim 1, other than the abstract idea
and law of nature themselves, are a generic processor and a probe. As
discussed above, claim 1 does not recite, and the Specification does not
describe, any unconventional hardware or software as being needed for the
processor to carry out the recited function, and “the mere recitation of a
generic computer cannot transform a patent-ineligible abstract idea into a
patent-eligible invention.” Alice, 573 U.S. at 223.
With regard to the immobilized probe, the Specification provides
evidence that using immobilized probes to determine the presence of a
specific nucleic acid sequence in a sample is conventional in the art. For
example, the Specification states that
[n]umerous forms of diagnostic kits employing arrays of
nucleotides are known in the art. They can be fabricated by any
number of known methods. . . . The DNA microarrays
generally have probes that are supported by a substrate so that a
target sample is bound or hybridized with the probes. . . . The
hybridized targets and probes can also be detected by voltage,
current, or electronic means known in the art.
Spec. ¶ 118. The Specification also states that “[v]arious techniques can be
employed for affixing an oligonucleotide for use in a microarray. In situ
synthesis of oligonucleotide or polynucleotide probes on a substrate is
performed in accordance with well-known chemical processes.” Id. ¶ 120.
“Immobilization of probes or oligonucleotides on a substrate or surface may
be accomplished by well-known techniques.” Id. ¶ 121.
The Specification does not disclose any unconventional aspects of the
“probe . . . affixed to a substrate” that is recited in claim 1. The only thing
about the recited probe that is specific to the claimed invention is that it is
designed to indicate the presence of a SNP comprising a TT genotype in
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SEQ ID NO: 1 or SEQ ID NO: 2. That aspect of the recited probe, however,
merely requires that it be capable of determining the natural correlation to
which the claim is directed.
Therefore, claim 1 requires only a generic processor and an
immobilized probe, both of which are used in a routine and conventional
way to carry out the data-gathering needed to determine the natural
correlation to which the claimed kit is directed. The combination of elements
recited in the method of claim 1 does not amount to significantly more than
the judicial exception itself, and under 35 U.S.C. § 101 the claimed kit is
ineligible for patenting.
Appellant’s Arguments
Appellant argues that
Claim 1 recites a processor that makes a treatment decision
based on the genotype of a patient. The treatment decision is
not the correlation between the SNPs and an increased risk of
VT or VF, the alleged law of nature. Instead the treatment
decision is the application of human actions to treat a patient,
which is in no way a law of nature.
Appeal Br. 11.
This argument is unpersuasive. Claim 1 is directed to a kit, not a
method of treating a patient. The claimed kit supplies information to a
clinician, who then decides what, if any, action to take with respect to a
patient. The information supplied by the claimed kit is whether implantation
of a CRT-D or ICD is indicated because the kit’s probe detects the presence
of a SNP comprising a TT genotype in SEQ ID NO: 1 or SEQ ID NO: 2, and
therefore the patient is at an increased risk of ventricular tachycardia or
ventricular fibrillation. Thus, the claimed kit does no more than supply
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information regarding the natural correlation between a SNP and the risk of
VT/VF.
Appellant also argues that “[p]rior to the invention, it was neither
routine nor conventional to make any treatment decisions based on the TT
genotypes for a patient or to determine an increased risk of VT or VF based
on the TT genotypes recited.” Appeal Br. 8–9. Appellant argues that,
“[g]iven that no examples in the prior art have been cited showing that a
processor making a treatment determination based on homozygosity for the
T alleles in the recited sequences . . . , the Examiner has failed to show that
the limitations of Claim 1 are ‘routine, well-understood, or conventional.’”
Id. at 9, citing Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).
This argument is unpersuasive. The relevant question is not whether
the natural correlation, to which the claim is directed, was routine or
conventional—i.e., known—at the time the invention was made. The
question is whether the claim includes additional elements that are not well-
understood, routine, and conventional, and that transform the claim into a
patent-eligible application of the natural correlation. See Alice, 573 U.S. at
217 (If “the claims at issue are directed to one of th[e] patent-ineligible
concepts . . . we consider the elements of each claim both individually and
‘as an ordered combination’ to determine whether the additional elements
‘transform the nature of the claim’ into a patent-eligible application.”).
Here, while it is true that “whether a claim element or combination of
elements is well-understood, routine and conventional to a skilled artisan in
the relevant field is a question of fact,” Berkheimer, 881 F.3d at 1368,
Appellant’s Specification itself provides sufficient evidence (as discussed
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above) to support a finding that both the processor and immobilized probe
recited in claim 1 were routine and conventional in the art as of the instant
application’s filing date.
Finally, Appellant argues that “Claim 1 does not seek to tie up any
method of detecting an increased risk of VT or VF. . . . Claim 1 is confined
to a specific embodiment of a diagnostic kit, and does not seek to preempt
any other use of the correlation between the recited genotypes and an
increased risk of VT or VF.” Appeal Br. 11.
This argument is also unpersuasive. “While preemption may signal
patent ineligible subject matter, the absence of complete preemption does
not demonstrate patent eligibility.” Ariosa Diagnostics, Inc. v. Sequenom,
Inc., 788 F3d 1371, 1379 (Fed. Cir. 2015). Where “claims are deemed only
to disclose patent ineligible subject matter under the Mayo framework, . . .
preemption concerns are fully addressed and made moot.” Id. Here, for the
reasons discussed above, we conclude that the claims on appeal are directed
only to patent-ineligible subject matter under the Mayo framework.
Preemption concerns in this case are fully addressed by that conclusion.
Claims 2–6, 8–12, and 21 were not argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
1–6, 8–12, 21 § 112(b) 1–6, 8–12, 21
1–6, 8–12, 21 § 101 1–6, 8–12, 21
Overall Outcome 1–6, 8–12, 21
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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).

AFFIRMED