MEDTRONIC, INC.

Patent Trials and Appeals Board

Jun 8, 2021

2020002698 (P.T.A.B. Jun. 8, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/750,624 01/25/2013 Janardan Vaidyanathan P036302.USU1/1123-105US01 8824
71996 7590 06/08/2021
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
BERHANU, ETSUB D
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
06/08/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
pairdocketing@ssiplaw.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 JANARDAN VAIDYANATHAN
____________________

Appeal 2020-002698
Application 13/750,624
Technology Center 3700
____________________

Before PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and
TARA L. HUTCHINGS, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–41. Appeal Brief 8; see also Final
Act. 2–22. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real parties in interest as
Medtronic, Inc. and its parent, Medtronic plc of Dublin, Ireland. Appeal
Br. 3.
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CLAIMED SUBJECT MATTER
Appellant’s claimed invention relates to implantable medical devices,
such as used to treat chronic pain, seizure disorders, and other conditions.
Spec. ¶¶ 1–2. According to the Specification:
[O]ne or more processors are configured to determine, based on
a sensed bioelectrical brain signal, whether efficacy of one or
more therapy parameter values with which therapy is delivered
to a patient may have changed. . . . [A] processor is configured
to generate a notification (e.g., delivered to the patient, patient
caretaker, or clinician) in response to determining that the
bioelectrical brain signal indicates efficacy of one or more
therapy parameter values with which therapy is delivered to a
patient may have changed. The notification may, for example,
indicate that evaluation of the one or more therapy parameter
values may be desirable, e.g., to re-program the medical device.
Id. ¶ 4.
Claims 1, 17, 33, and 36 are independent, and claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A method comprising:
controlling, with one or more processors, a medical device
to deliver therapy to a patient according to a therapy program;
selecting, with the one or more processors, a biomarker
stored in a memory, wherein the biomarker indicates a response
of the patient to the therapy delivered by the medical device
according to the therapy program may have changed relative to a
response of the patient to the therapy delivered by the medical
device according to the therapy program when the patient was in
a baseline state in which efficacious therapy delivery by the
medical device according to the therapy program was observed;
receiving, with the one or more processors, information
representative of a bioelectrical brain signal of the patient;
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determining, with the one or more processors, whether the
bioelectrical brain signal includes the biomarker; and
generating, with the one or more processors, a notification
based on determining the bioelectrical brain signal includes the
biomarker.

REJECTIONS
I. Claims 40 and 41 are rejected under 35 U.S.C. § 112, fourth
paragraph, for improper dependency for failing to further limit the subject
matter of parent claims 1 and 17, respectively. Final Act. 2–3; Ans. 3.
II. Claims 1–12, 16–27, 31–34, 36, 40, and 41 are rejected under 35
U.S.C. § 101 as ineligible for patent protection. Final Act. 3–5; Ans. 3–5.
III. Claims 1, 2, 4, 5, 8–15, 17, 18, 20, 21, 23–30, and 33–41 are rejected
under 35 U.S.C. § 103(a) as unpatentable over Drew2 and Virag.3 Final Act.
6–14;4 Ans. 5–9.
IV. Claims 1, 2, 6, 8, 13–15, 17, 18, 22, 23, 28–30, 33, and 35–41 are
rejected under 35 U.S.C. § 103(a) as unpatentable over Drew and
Dilorenzo.5 Final Act. 14–18; Ans. 5–9.

2 Drew (US 2006/0094970 A1, published May 4, 2006).
3 Virag (US 2007/0249954 A1, published Oct. 25, 2007).
4 The Examiner additionally relies on Official Notice in rejecting dependent
claim 15. Final Act. 13. As support for the truth of the statement as to
which the Examiner takes Official Notice, the Examiner cites Adams
(US 5,449,377, issued Sept. 12, 1995). Id.
5 Dilorenzo (US 2007/0287931 A1, published Dec. 13, 2007).
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V. Claims 3 and 19 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Drew, Virag, and Lange.6 Final Act. 19; Ans. 9–10.
VI. Claims 3 and 19 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Drew, Dilorenzo, and Lange. Final Act. 19–20; Ans. 9–10.
VII. Claims 16 and 31 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Drew, Virag, Osorio ʼ407,7 and Osorio ʼ119.8 Final Act.
20.
VIII. Claims 16, 31, and 32 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Drew, Dilorenzo, Osorio ʼ407, and Osorio ʼ119. Final
Act. 21–22; Ans. 10.

ANALYSIS
I. Improper Dependency
The Examiner rejects claims 40 and 41 under 35 U.S.C. § 112, fourth
paragraph, for improper dependency from independent claims 1 and 17,
respectively. Final Act. 2–3; Ans. 3. See Pfizer, Inc. v. Ranbaxy Labs. Ltd.,
457 F.3d 1284, 1291–92 (Fed. Cir. 2006) (holding that 35 U.S.C. § 112,
fourth paragraph, is a proper ground for rejecting a claim); MANUAL OF
PATENT EXAMINING PROCEDURE (“MPEP”) § 608.01(n), ¶ III (9th edition,

6 Lange (US 2002/0123693 A1, published Sept. 5, 2002).
7 Osorio ʼ407 (US 2007/0244407 A1, published Oct. 18, 2007).
8 Osorio ʼ119 (US 2004/0133119 A1, published July 8, 2004).
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rev. Oct. 2019).9 As explained below, claim 40 does not further limit the
method recited in parent claim 1, and claim 41 does not further limit the
system recited in claim 17. Consequently, we sustain the rejection.
The limitation at issue in this rejection deals with when the medical
device observes the baseline response of the patient in relation to when the
medical device delivers the therapy.
Claim 1 recites a method including the step of selecting a biomarker
wherein the biomarker indicates there may have been a change between two
responses to therapy delivered by the medical device. The two responses
are: (1) a response when the patient was in a baseline state (“baseline
response”), and (2) another response (“subsequent response”). The baseline
response is taken when the patient is in a baseline state “in which efficacious
therapy delivery by the medical device according to the therapy program
was observed.”
The Specification describes that sensed bioelectrical brain signals of a
patient may be used to characterize the brain state of a patient. The
bioelectrical signal may include a biomarker that indicates efficacy of the
therapy delivered to the patient. Spec. ¶ 6. More specifically, a bioelectrical
brain signal indicative of a subsequent patient response to therapy may be
compared to a baseline response of the patient to therapy to determine if the
response to therapy changed. Id. ¶¶ 41, 42.

9 All references to the MPEP in this opinion will be to the most current
edition and revision, unless otherwise noted.
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Claim 40 recites:
The method of claim 1, wherein the baseline state is a state in
which the patient was receiving efficacious therapy delivery by
the medical device.
A baseline response, as required by claim 1, is taken when therapy for
the patient was observed, and claim 40 purports to further limit the baseline
response of parent claim 1 to when the patient was receiving therapy.
The Examiner determined that, “[i]n order for the baseline state to be
one in which efficacious therapy delivery by the medical device was
observed, the patient would need to be receiving the efficacious therapy
delivery by the medical device.” Final Act. 2. In other words, the Examiner
reasons that the response of patient in a baseline state can only be observed
(as required by claim 1) if the patient was receiving therapy while being
observed (as recited in claim 40). Id.
Appellant argues that claim 1 does explicitly recite that “the baseline
state is a state in which a patient was receiving therapy delivery.” Appeal
Br. 9. Appellant argues that claim 1 covers observing the response of the
patient both after the patient received the therapy and while the patient was
receiving therapy. Appeal Br. 9. According to Appellant, claim 40 is
narrower than claim 1 in that it is limited to one of the two possibilities of
claim 1, namely, observing the response while the patient is receiving
therapy. Id. Appellant asserts that the Examiner provided no support for the
assertion that the baseline response can only be observed while the patient is
receiving therapy. Id. at 10.
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Claim 1 recites that the baseline response is taken “when . . . therapy
delivery by the medical device . . . was observed.” The plain meaning of
this language is that the response is taken (observed) while the device
delivers therapy. In other words, the baseline response is taken as the
therapy is delivered. Appellant’s general assertion that the Examiner’s
position is unsupported does not effectively demonstrate error in the
Examiner’s position.
We disagree with Appellant’s assertion that the baseline response may
be observed either while the patient is receiving therapy or after the patient
is receiving therapy. See Appeal Br. 9. If the response is taken after the
therapy is delivered, the patient would no longer be in a baseline state. See
generally, Spec. ¶ 42 (describing that a baseline response means a response
accessed when “efficacious therapy was observed”); see also ¶¶ 43, 72
(making similar descriptions).
Appellant asserts that the baseline state does not have to “coincide
with the actual receipt of therapy by the patient, e.g., the same time period
during which an electrical stimulation signal, a drug, or other therapy was
actively being delivered to the patient.” Reply Br. 3. According to
Appellant, an ordinarily skilled artisan “would understand that the effects of
therapy delivery may be observed after a medical device delivers the
therapy, e.g., after the medical device delivers an electrical stimulation
signal to the patient, rather than during delivery of the electrical signal to the
patient” and “[t]he Examiner overlooks the possibility that the efficacious
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therapy delivery could be observed after the medical device actively delivers
an electrical stimulation signal or other therapy to a patient.” Id.; see also
Appeal Br. 9–10. However, there is no language recited in either claim 1 or
claim 40 aimed at “efficacious therapy delivery” being observed “after” the
medical device actively delivers an electrical stimulation signal or other
therapy to a patient. Additionally, the recitation in claim 1 that efficacious
therapy delivery by the medical device “was observed” is indicative of the
effects of therapy delivery taking place “during” delivery of the electrical
signal or other therapy to a patient. See Ans. 3.
For similar reasons, the Examiner properly rejected claim 41 under 35
U.S.C. § 112, fourth paragraph, for improper dependency from claim 17.
Appellant points out that parent claim 17, unlike parent claim 1, is a system
claim; and contends that “[c]laim 41 recites further structural limitations of
the claimed system at least because claim 41 specifies that the memory of
claim 17 stores a particular biomarker.” Appeal Br. 10. We need not reach
the question whether claim 41 recites a structural (rather than functional)
limitation of the subject matter of claim 17 (see Final Act. 2–3; Appeal Br.
11) because Appellant’s contention is based on a faulty premise, namely,
that claim 41 narrows the class of biomarkers that might be stored in the
memory recited in claim 17.
We sustain the rejection of claims 40 and 41 under 35 U.S.C. § 112,
fourth paragraph, for improper dependency from independent claims 1 and
17, respectively.
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II. Patent Eligibility
The Examiner rejects claims 1–12, 16–27, 31–34, 36, 40, and 41
under 35 U.S.C. § 101 as ineligible for patent protection. Final Act. 3–5;
Ans. 3–5. Appellant argues the patent eligibility of claim 1 (see Appeal Br.
11–23; Reply Br. 4–7), and asserts that independent claims 17, 33, and 36
and the dependent claims are patent-eligible for similar reasons (Appeal Br.
19–20, 22–23). Therefore, we select claim 1 as representative for purposes
of this rejection. See 37 U.S.C. § 41.37(c)(1)(iv).
Principles of Law
There are two criteria for determining patent subject matter eligibility.
MPEP § 2106 ¶ I. First, the claim must recite a “process, machine,
manufacture, or composition of matter.” 35 U.S.C. § 101; see also MPEP
§ 2106 ¶ I. Claim 1, according to its preamble and structure, recites a
method or process. Final Act. 3. Therefore, it falls within one of the four
categories of patentable subject matter enumerated in 35 U.S.C. § 101.
Second, the claimed invention must qualify as patent-eligible subject
matter (i.e., the claim must not be directed to a judicial exception unless the
claim as a whole includes additional limitations amounting to significantly
more than the exception). MPEP § 2106 ¶ I. As explained in the MPEP,
determining that a claim falls within one of the four enumerated
categories of patentable subject matter recited in 35 U.S.C. 101
(i.e., process, machine, manufacture, or composition of matter)
. . . does not end the eligibility analysis, because claims directed
to nothing more than abstract ideas (such as a mathematical
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formula or equation), natural phenomena, and laws of nature are
not eligible for patent protection.
MPEP § 2106.04 ¶ I10 (citing Diamond v. Diehr, 450 U.S. 175, 185 (1981);
Alice Corp. v. CLS Bank Int'l, 573 U.S. 208, 216 (2014) (citing Ass’n for
Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013));
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980); Parker v. Flook, 437
U.S. 584, 589 (1978); Gottschalk v. Benson, 409 U.S. 63, 67–68 (1972)).
The Supreme Court has laid out a two-step framework for determining
whether the claimed invention qualifies as patent-eligible subject matter.
Alice, 573 U.S. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66 (2012)).
In the first step of this framework, we must determine whether the
claim is “directed to” a judicial exception, such as a law of nature, natural
phenomenon, or abstract idea. See Alice, 573 U.S. at 219 (“On their face,
the claims before us are drawn to the concept of intermediated settlement,
i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v.

10 In 2019, the PTO published revised guidance on the application of
§ 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (Jan. 7, 2019). That guidance, together with a memorandum from
the Deputy Commissioner for Patent Examination Policy, entitled “Changes
in Examination Procedure Pertaining to Subject Matter Eligibility, Recent
Subject Matter Decision (Berkheimer v. HP, Inc.),” and dated April 19,
2018, has been incorporated into MPEP §§2103–2106.07(c). Subject Matter
Eligibility, https://www.uspto.gov/PatentEligibility (last accessed Nov. 2,
2020). In this opinion, we will cite to the MPEP rather than to the published
guidance or the memorandum. See id.

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Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’
application explain the basic concept of hedging, or protecting against
risk.”). As applied by the Patent and Trademark Office, this step (i.e., Step
2A) has two “prongs.” MPEP § 2106.04 ¶ II.A. In Step 2A, Prong One, we
evaluate whether the claim recites, that is, sets forth or describes, a judicial
exception. MPEP § 2106.04 ¶ II.A.1.
Nevertheless, “it is not enough to merely identify a patent-ineligible
concept underlying the claim; we must determine whether that
patent-ineligible concept is what the claim is ‘directed to.’” Endo Pharms.
Inc. v. Teva Pharms. USA, Inc., 919 F.3d 1347, 1353 (Fed. Cir. 2019)
(quoting Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.2d 1042, 1050
(Fed. Cir. 2016)). Therefore, in Step 2A, Prong Two, we must “evaluate
whether the claim as a whole integrates the exception into a practical
application of that exception.” MPEP § 2106.04 ¶ II.A.2; see also id.
§ 2106.04(d)(2).
In analyzing the claim under Step 2A, Prong Two:
One way to demonstrate [integration of a judicial exception into
a practical application] is when the additional elements apply or
use the recited judicial exception to effect a particular treatment
or prophylaxis for a disease or medical condition. The
application or use of the judicial exception in this manner
meaningfully limits the claim by going beyond generally linking
the use of the judicial exception to a particular technological
environment, and thus transforms a claim into patent-eligible
subject matter.
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MPEP § 2106.04(d)(2). Indeed, the case law recognizes a distinction
between claims to “diagnostic” methods, which typically are held to be
directed to exceptions, such as natural laws; and “treatment” methods, which
typically are held to be eligible for patent protection. Vanda Pharms. Inc. v.
West-Ward Pharms. Int’l Ltd., 887 F.3d 1117, 1134 (Fed. Cir. 2018).,
In Step 2B of the analysis, “we must examine the elements of the
claim to determine whether it contains an ‘inventive concept’ sufficient to
‘transform’ the claimed [judicial exception] into a patent-eligible
application.” Alice, 573 U.S. at 221. “Evaluating additional elements to
determine whether they amount to an inventive concept requires considering
them both individually and in combination to ensure that they amount to
significantly more than the judicial exception itself.” MPEP
§ 2106.05 ¶ I. One consideration that may be taken into account in
determining whether the claim amounts to significantly more that the
concept falling within the judicial exception is whether the claim merely
associates the concept with an article, machine, or activity, described at a
high level of generality, that is well-understood, routine, and conventional in
the industry. MPEP § 2106.05(d).
Step 2A, Prong One
Natural Law
Appellant argues that the Examiner erred in determining that claim 1
recites a law of nature, because the Examiner mischaracterized the claim by
omitting elements of the claim and overgeneralized the subject matter.
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Appeal Br. 13–14. For the reasons that follow, we are not persuaded by this
argument.
Appellant’s Specification is titled “NOTIFICATION INDICATIVE
OF A CHANGE IN EFFICACY OF THERAPY” and describes a problem
in the prior art involving therapy delivered to a patient by a medical device
becoming “less efficacious over time.” Spec. ¶ 49. Numerous potential
factors contribute to this decrease in efficacy, including: issues with the
medical device, such as leads at the therapy delivery site migrating; the
patient adapting to, becoming de-sensitized, or otherwise developing a
tolerance to the therapy delivered; the patient’s condition changing over
time, including symptoms improving or worsening; and disease progression.
See id. The inventor of the claimed invention recognized that sensed
bioelectrical brain signals of a patient may be used to characterize a patient’s
brain state when efficacious therapy is delivered and when less efficacious
therapy is delivered. See id. ¶¶ 41–42; see also id. ¶¶ 4, 6. In particular, the
patient’s bioelectrical brain signals may include a signal characteristic
(called a biomarker) that is indicative of the patient being in a state in which
the effects of therapy may have diminished. Id. ¶¶ 41–42, 72. The
biomarker may be specific to a patient, a patient condition, or both. Id. ¶ 42.
It may include a time domain characteristic of a bioelectrical brain signal, a
frequency domain characteristic, a pattern of the bioelectrical brain signal
over time, some other measurable characteristic a sensed bioelectrical brain
signal, or an absence of a particular characteristic (e.g., having no energy
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level in a particular frequency band above a threshold level). Id. The
Specification instructs that the biomarker is selected by the user of the
claimed invention “to be indicative of a patient state in which therapy
delivery by [the medical device] is not sufficiently efficacious.” Id. ¶ 44;
see also id. ¶ 72. In response to detecting a bioelectrical brain signal having
the biomarker, a notification is generated for the patient or patient caretaker,
indicating that the therapy should be evaluated to improve efficacy. Id. ¶ 41.
Consistent with this description, claim 1 recites a method comprising,
in part,
selecting . . . a biomarker . . . , wherein the biomarker
indicates a response of the patient to the therapy delivered by the
medical device according to the therapy program may have
changed relative to a response of the patient to the therapy
delivered by the medical device according to the therapy program
when the patient was in a baseline state in which efficacious
therapy delivery by the medical device according to the therapy
program was observed[.]
This limitation recites a relationship between a biomarker included in a
patient’s bioelectrical brain signal and a change in efficacy of the therapy
delivered to the patient. Because the presence of the biomarker in the
bioelectrical brain signal is simply the consequence of natural processes
performed by the brain of the patient in response to the therapy delivered by
the patient, this limitation sets forth a law of nature, i.e., a judicial exception.
See Final Act. 3 (concluding that claim 1 sets forth a law of nature).
We agree with the Examiner that this law of nature is similar (albeit at
a higher-level of generality) to the laws of nature identified by the Supreme
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Court in Mayo. Final Act. 3. The patents at issue in Mayo concerned the
use of thiopurine drugs in the treatment of autoimmune diseases, such as
Crohn’s disease and ulcerative colitis. Mayo, 566 U.S. at 73. Because
people metabolize thiopurine compounds differently, the same dose of
thiopurine drug affects different people differently. Id. The representative
claim11 in Mayo embodies findings that a level of the metabolite, 6-
thioguanine (6-TH) greater than about 400 picomoles (pmol) per 8x108 red
blood cells indicates that the dosage is likely too high for the patient, while
less than about 230 pmol per 8x108 red blood cells indicates that the dosage
is likely too low. Id. at 74. The Supreme Court held that the “relationships
between concentrations of certain metabolites in the blood and the likelihood

11 The representative claim read as follows:
1. A method of optimizing therapeutic efficacy for
treatment of an immune-mediated gastrointestinal disorder,
comprising:
(a) administering a drug providing 6-thioguanine
(“6-TG”) to a subject having said immune-mediated
gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said
subject having said immune-mediated gastrointestinal
disorder,
wherein the level of 6-thioguanine less than about 230
pmol per 8×10 8 red blood cells indicates a need to increase the
amount of said drug subsequently administered to said subject
and wherein the level of 6-thioguanine greater than about 400
pmol per 8×10 8 red blood cells indicates a need to decrease the
amount of said drug subsequently administered to said subject.
Mayo, 566 U.S. at 74–75 (internal quotations omitted).
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that a dosage of a thiopurine drug will prove ineffective or cause harm” was
a natural law, resulting from natural processes that occur when the body
metabolizes thiopurine compounds. Mayo, 566 U.S. at 77.
Here, claim 1 is broader than the representative claim of Mayo in that
it requires a user to “select” a biomarker that embodies the natural law (i.e.,
indicates when a patient’s response to the therapy has changed). That is,
unlike Mayo, which administered a particular drug and set forth upper and
lower thresholds for levels of that drug in the patient’s blood indicating that
the dosage is too high or too low, claim 1 covers any “therapy” and any
“biomarker” so long as it indicates that the patient’s response to the therapy
may have changed relative to the patient’s baseline state in which efficacious
therapy delivery was observed. See Spec. ¶ 26 (describing that the invention
includes delivering various types of therapy, including the delivery of drugs
and electrical stimulation).
We also are not persuaded of Examiner error by Appellant’s
arguments that claim 1 is eligible for a streamlined eligibility analysis, and
does not tie up a law of nature. Appeal Br. 12–13, 22. As an initial matter,
we note that the streamlined analysis “is not a means of avoiding a finding
of ineligibility,” because its results “will always be the same as the full
[eligibility] analysis.” MPEP § 2106.06. A streamlined eligibility analysis
is a discretionary tool available to examiners when the patent eligibility of a
claim is self-evident. Id. If there is any doubt as to eligibility, an examiner
should conduct a full analysis to determine whether the claim integrates the
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judicial exception into a practical application or recites significantly more
than the judicial exception. Id. Here, it is not self-evident that claim 1 is
patent eligible and, as such, the Examiner properly performed a full § 101
analysis of the claim.
To the extent Appellant maintains that claim 1 is patent eligible
because there is no risk of preemption of the natural law, Appellant
misapprehends the controlling precedent. Although the Supreme Court has
described “the concern that drives [the exclusion of abstract ideas from
patent-eligible subject matter] as one of pre-emption,” Alice, 573 U.S.
at 216, characterizing preemption as a driving concern for patent eligibility
is not the same as characterizing preemption as the sole test for patent
eligibility. “The Supreme Court has made clear that the principle of
preemption is the basis for the judicial exceptions to patentability” and “[f]or
this reason, questions on preemption are inherent in and resolved by the
§ 101 analysis.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371,
1379 (Fed. Cir. 2015) (citing Alice Corp., 573 U.S. at 216). “[P]reemption
may signal patent ineligible subject matter, [but] the absence of complete
preemption does not demonstrate patent eligibility.” Id.
For these reasons, we are not persuaded that the Examiner erred in
concluding that claim 1 recites a natural law. See Final Act. 3.

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Collecting, Analyzing, and Displaying Information
The Examiner also concludes that claim 1 is directed to the collection,
analysis, and display of information; and that the collection, analysis, and
display of information is an abstract idea ineligible for patent protection.
Final Act. 3 (citing Elec. Power Grp. v. Alstom S.A., 830 F.3d 1350 (Fed.
Cir. 2016)). In particular, the Examiner concludes that the first three steps
of claim 1 (controlling, selecting, and receiving) comprise data collection
steps; the “determining” step is an analysis step; and the final “generating”
step is the equivalent of a display step. Id. Appellant challenges this
conclusion, arguing (among other things) that the Examiner has not
identified a specific limitation setting forth, or describing, the purported
abstract idea. Appeal Br. 16.
As noted earlier, we agree with the Examiner that claim 1 recites a
natural law. Final Act. 3. Therefore, we need not further address whether
claim 1 recites an abstract idea, and we need not address to what extent,
claim 1 may be analogous to the claim at issue in Electric Power Group.
See Appeal Br. 15–16.

Step 2A, Prong Two
We are not persuaded by Appellant’s argument that claim 1 is not
directed to a natural law because it integrates the recited natural law into a
practical application (Step 2A, Prong Two). See Appeal Br. 17–19. In this
regard, Appellant contends that claim 1, like the patent-eligible claims at
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issue in Vanda, Endo Pharmaceuticals, and Natural Alternatives,12 applies
the natural law to effect a particular treatment or prophylaxis for a disease or
medical condition. Id.; see also MPEP § 2106.04(d)(2). According to
Appellant, claim 1 “enables active management of therapy delivered to a
patient when a patient’s response to a therapy program may have changed.”
Id. at 18; see also Reply Br. 6 (asserting that claim 1 “manag[es] when the
medical device may need to be reprogrammed or reassessed”). Appellant’s
argument is not persuasive, as described in more detail below, at least
because it is not commensurate in scope with claim 1.
Beyond the judicial exception, claim 1 additionally recites:
“controlling, with one or more processors, a medical device to deliver
therapy;” “selecting, with the one or more processors,” the biomarker
“stored in memory”; “receiving, with the one or more processors,
information representative of a bioelectrical brain signal of the patient;”
“determining, with the one or more processors, whether the bioelectrical
brain signal includes the biomarker;” and “generating, with the one or more
processors, a notification based on determining the bioelectrical brain signal
includes the biomarker.” Appeal Br. 52 (Claims Appendix). We agree with
the Examiner that none of these limitations, considered individually and in
combination, provides a treatment, much less a particular treatment that
would integrate the natural law into a practical application. See Ans. 4

12 Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d
1338 (Fed. Cir. 2019).
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(“There is no therapy provided to the patient in response to the generated
notification.”).
Instead, the additional limitations generally link the judicial exception
to a particular technological environment (i.e., involving one or more
processors, a medical device, a biomarker stored in memory) of field of use
(therapy delivered by a medical device), and amount to insignificant extra-
solution activity. See Final Act. 4; see also MPEP §§ 2106.05(g)–(h).
For example, the “controlling” and “receiving” steps, much like
Mayo’s “administering” step, are performed to obtain the data from which
an inference regarding therapy efficacy may be drawn in light of the
biomarker. Specifically, any “therapy” for any disease or medical condition
is delivered to a patient by any “medical device” according to any “therapy
program,” and the patient’s bioelectrical brain signal responding to such
therapy is received. See Mayo, 566 U.S. at 79 (“The upshot is that the
[claimed] steps simply tell doctors to gather data from which they may draw
an inference in light of the correlations.”); see also In re Grams, 888 F.2d
835, 840 (Fed. Cir. 1989) (holding that “patentability here is precluded by
the fact that [the step of ‘performing clinical tests on individuals’] merely
provides data for the [judicial exception]”).
The “selecting” and “determining” steps, much like the “determining”
step in Mayo, tell the user to select a biomarker (comprising the natural law)
by any means, and determine, by any means, whether the biomarker is
present in the data collected. See Mayo, 566 U.S. at 79 (holding that the
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“‘determining’ step tells the doctor to determine the level of the relevant
metabolites in the blood, through whatever process the doctor or laboratory
wishes to use” and, thus, does not transform an unpatentable law of nature
into a patent-eligible application of such a law). For example, after
describing exemplary techniques for determining whether a sensed
bioelectrical brain signal includes a biomarker, Appellant’s Specification
provides that “[o]ther techniques are also contemplated.” Spec. ¶ 43. See
also Spec. ¶¶ 42, 44, 72 (describing, at a high level, exemplary biomarkers
for selection), 45, 97 (describing, at a high level, exemplary ways to
determine whether a bioelectrical brain signal includes the biomarker).
The presence of the biomarker in the patient’s bioelectrical brain
signal indicates that therapy efficacy may have changed. See Spec. ¶¶ 4, 6,
49, 72. The final step of “generating . . . a notification based on determining
the bioelectrical brain signal includes the biomarker,” thus, is performed to
report this potential issue concerning a change in the therapy’s efficacy to a
patient, patient caretaker, or clinician. Id. ¶¶ 4, 6. According to the
Specification, the generated notification indicates to a patient, patient
caretaker, or clinician, a need to evaluate one or more therapy parameter
values and to re-program the medical device to improve efficacy. See id.;
see also id. ¶ 48 (describing actions that may be performed “[i]n response to
receiving the notification generated”); 49 (“By generating a notification. . . ,
therapy system 10 is configured to actively manage when [the medical
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device] may need to be reprogrammed or at least reassessed by a
clinician.”).
Put simply, the step of generating a notification is performed to report
certain results of the data collection and analysis recited in the prior method
steps. At most, this limitation amounts to a nominal or insignificant
relationship to the natural law. See MPEP § 2106.05(d)(2) ¶ (b) (providing
that the treatment limitation have more than a nominal or insignificant
relationship to the judicial exception). While further action may be
contemplated in view of receiving a notification (see, e.g., Spec. ¶ 48), no
such action is recited in claim 1. Claim 1, including the step of generating a
notification, does not “affirmatively recite an action that effects a particular
treatment or prophylaxis for a disease or medical condition,” as required in
order to quality as a “treatment” or “prophylaxis” limitation for purposes of
this consideration. Id. ¶ MPEP § 2106.05(d)(2); see also id.
§ 2106.05(d)(2) ¶ (a) (instructing that the treatment or prophylaxis limitation
must be “particular,” which means “specifically identified”).
Appellant argues that claim 1 “enables active management of therapy
delivered to a patient when a patient’s response to a therapy program may
have changed (e.g., by managing when the medical device may need to be
reprogrammed or reassessed).” Reply Br. 6 (citing Spec. ¶¶ 4, 5, 49). Yet,
any such subsequent action taken by the patient, caretaker, or clinician to
manage therapy delivered to a patient in response to the notification is
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beyond the scope of the claim because performing each of the method steps
recited in claim 1 results merely in generating a notification.
Here, Appellant does not persuade us that claim 1 recites an additional
limitation beyond the natural law demonstrating that the claim as a whole
integrates the natural law into a practical application. Instead, claim 1,
considered as a whole, focuses on detecting when the efficacy of the therapy
program has changed. See Endo, 919 F.3d at 1356 (distinguishing its patent-
eligible claims for “treating pain in patients with impaired renal function”
from patent-ineligible claims that result in “simply an observation or
detection”).
Appellant’s assertion that claim 1 is analogous to the claims at issue in
Vanda, Endo, and Natural Alternatives is non-availing for the same reasons.
Unlike claim 1, the claims at issue in each of the cases cited by Appellant
were directed to a particular treatment for a disease or medical condition, not
to a diagnostic method based on natural processes. For example, the claims
in Vanda involved a method of treating patients with schizophrenia that first
required performing a genetic test to determine if a patient was a CYPD2D6
performer. Vanda, 887 F.3d at 1121. Based on the results of that test, the
claimed method selected and internally administered a particular dose of
iloperidone, thereby decreasing the risk of a dangerous side effect, QTc
prolongation. Id. at 1121, n.2. The Federal Court explained that the claims
were not directed to the natural relationship between iloperidone, CYP2D6
metabolism, and the risk of QTc prolongation, but rather to a patent-eligible
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method of using iloperidone to treat schizophrenia. Id. at 1136 (“[T]he
claims here are directed to a specific method of treatment for specific
patients using a specific compound at specific doses to achieve a specific
outcome.”)
In Endo, the Federal Circuit determined that the claims at issue were
“legally indistinguishable from the representative claim in Vanda.” Endo,
919 F.3d at 1353. In that case, the claims at issue recited a method for
treating a patient with a particular dosage regimen based on the results of
kidney function testing. Id. at 1353–54; see also id. at 1354 (holding that the
claims recite “a method of treatment including specific steps to adjust or
lower the oxymorphone dose for patients with renal impairment” and, thus,
are “directed to more than just reciting the natural relationship”). Similarly,
in Natural Alternatives, the Federal Circuit also determined that the claims
at issue, which administered certain quantities of beta-alanine to increase the
anaerobic working capacity in a human, “are treatment claims and as such
they are patent eligible.” Natural Alternatives, 918 F.3d at 1344.
Unlike the claims at issue in the cases cited by Appellant, claim 1
does not recite a specific method of treatment for specific patients using a
specific compound at specific doses to achieve a specific outcome or
anything comparable. Quite the contrary, claim 1 does not go beyond
recognizing that the bioelectrical brain signal includes the biomarker (a
natural law), and generating a notification when it does. While this
notification may well indicate a need to modify the generically-claimed
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“therapy,” claim 1, like the representative claim in Mayo, does not require
any modification or further assessment of the therapy delivered to the patient
based on the recited “determining” step. See Mayo, 566 U.S. at 75 (“[A]
doctor . . . could violate the patent even if he did not actually alter his
treatment decision in light of the test.”). In this way, claim 1, like the
representative claim in Mayo (and contrary to Appellant’s arguments
regarding pre-emption (see Appeal Br. 13, 22)), would “tie up the doctor’s
subsequent treatment decision whether that treatment does, or does not
change in light of the inference he has drawn using the [biomarker].” Mayo,
566 U.S. at 86–87.
Appellant additionally argues that claim 1 “provides an improvement
to the technical process and the technical field of delivering therapy by a
medical device.” Appeal Br. 21; see also MPEP §§ 2106.04(d)(1)
(instructing that improvements to any other technology or technical field can
be evaluated at Step 2A, Prong Two). Specifically, Appellant contends that
claim 1 enables a clinician to improve a process for delivering therapy to a
patient based on the result of the claimed “determining” step. See Appeal
Br. 20–22. For example, based on the result from “determining,” a clinician
could improve the process for delivering therapy by: qualifying patients
prior to seeing a physician; reducing the frequency of patient visits;
prioritizing patients; and/or evaluating one or more therapy parameters. Id.
at 21 (citing Spec. ¶¶ 4, 50).
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However, the only step recited in claim 1 that uses the results from
performing the “determining” step is the step of generating a notification.
As discussed above, generating a notification amounts to reporting certain
results of the step of determining — namely, that the bioelectrical brain
signal includes the biomarker, i.e., the judicial exception. For at least this
reason, Appellant does not persuade us that the step of generating,
considered individually and as an ordered combination, reflects a
technological improvement, or otherwise imposes a meaningful limit on the
judicial exception, such that claim 1 as a whole integrates the judicial
exception into a practical application.
Appellant also argues that claim 1 is analogous to the claims at issue
in McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir.
2016), because it recites a “specific way to determine if a patient’s response
to a therapy program delivered by a medical device may have changed.”
Appeal Br. 19. According to Appellant, claim 1 is analogous to the claims at
issue in McRO because it provides “a particular solution to a problem or a
particular way to achieve a desired outcome defined by the claimed
invention, as opposed to merely claiming the idea of a solution or outcome.”
Id. Yet, we do not see any parallel between the rules described
in McRO that result in an improvement to technology in 3-D animation
techniques, and the result-based, functional limitations recited in claim 1.
For example, claim 1 recites the method steps of “controlling,” “selecting,”
“receiving,” “determining,” and “generating,” such that they are capable of
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being achieved by any means. Intellectual Ventures I LLC v. Capital One
Fin. Corp., 850 F.3d 1332, 1342 (Fed. Cir. 2017) (“[T]he claim language
here provides only a result-oriented solution, with insufficient detail for how
a computer accomplishes it. Our law demands more.”) (citing Elec. Power
Grp., 830 F.3d at 1356 (cautioning against claims “so result focused, so
functional, as to effectively cover any solution to an identified problem”).
Therefore, we are not persuaded that claim 1, as a whole, integrates
the judicial exception into a practical application.
Step 2B
We are not persuaded by Appellant’s argument that claim 1 adds
specific limitations beyond the natural law that amount to “significantly
more” than the natural law, so as to provide an inventive concept sufficient
to transform the natural law into a patent-eligible application. See Appeal
Br. 20–23; see also Reply Br. 6–7. Instead, we agree with the Examiner that
the additional elements recited in claim 1 beyond the judicial exception (i.e.,
“controlling, with one or more processors, a medical device to deliver
therapy;” “selecting, with the one or more processors” the biomarker “stored
in memory”; “receiving, with the one or more processors, information
representative of a bioelectrical brain signal of the patient;” “determining,
with the one or more processors, whether the bioelectrical brain signal
includes the biomarker;” and “generating, with the one or more processors, a
notification based on determining the bioelectrical brain signal includes the
biomarker”) considered individually and in combination do not amount to
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significantly more than the judicial exception. See Final Act. 3–5. We
address Appellant’s argument in more detail below.
Appellant asserts that Appellant does not concede that the steps of
controlling a medical device to deliver therapy to a patient according to a
therapy program and selecting a biomarker stored in memory are well-
understood, routine, and conventional activity. Appeal Br. 19 (citing Final
Act. 4). Yet, Appellant’s Specification in the Background section describes
known therapy systems for controlling a medical device to deliver therapy to
a patient according to a therapy program. See Spec. ¶¶ 2–3. Additionally,
the step of “selecting” involves no more than generic computer components
(i.e., “one or more processors” and “memory”) to implement the well-
understood, routine, and conventional computer function of retrieving data
(i.e., “selecting” the biomarker from “memory”). See Alice, 573 U.S. at 225
(determining that “the use of a computer to obtain data” is well-understood,
routine, and conventional activity).
Appellant also contends that claim 1 improves a technical process and
technical field of delivering therapy by a medical device by enabling active
management of therapy delivered to the patient when the patient’s response
to a therapy may have changed, such as by managing when the medical
device may be reprogrammed or reassessed. Appeal Br. 21–22. This
argument is unpersuasive for the same reasons set forth above with respect
to Step 2A, Prong Two of the analysis — namely, it is not commensurate
with the scope of claim 1.
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Appellant further contends that claim 1 recites “a method to determine
if a patient’s response to a therapy program delivered by a medical device
may have changed in a specific way.” Id. at 22. Yet, the step of
determining that a patient’s response to the delivered therapy may have
changed involves determining, by any manner, when the patient’s
bioelectrical brain signal includes the biomarker, i.e., the unpatentable law
of nature itself. It is well-settled that the inventive concept “cannot be
furnished by the unpatentable law of nature . . . itself.” Genetic Techs. v.
Merial LLC, 818 F.3d 1369, 1376 (Fed. Cir. 2016); see also Mayo, 566 U.S.
at 72–73 (requiring that “a process that focuses upon the use of a natural law
also contain other elements or a combination of elements, sometimes
referred to as an ‘inventive concept,’ sufficient to ensure that the patent in
practice amounts to significantly more than a patent upon the natural law
itself” (emphasis added) (citation omitted)); BSG Tech LLC v. BuySeasons,
Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018) (“It has been clear since Alice
that a claimed invention’s use of the ineligible concept to which it is directed
cannot supply the inventive concept that renders the invention ‘significantly
more’ than that ineligible concept.”); MPEP § 2106.05.
Here, the claimed step of “determining”, like the “determining” step
in Mayo, is recited at such a high-level of generality that it covers any
technological means for achieving the desired functionality, even later
discovered processes. See Final Act. 5 (concluding that the determining step
is recited at a “high level of generality” that compass conventional EEG
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signal analysis methods); see also Mayo, 566 U.S. at 79 (concluding that the
“determining” step instructs doctors “to determine the level of the relevant
metabolites in the blood, through whatever process the doctor or the
laboratory wishes to use” and, thus, is not sufficient to transform an
unpatentable law of nature into a patent-eligible application”); id. at 87
(further concluding that the “determining” step is “set forth in highly general
language, covering all processes that make use of the correlations after
measuring metabolites, including later discovered processes that measure
metabolite levels in new ways”). Appellant fails to persuade us that the
determining step of claim 1, considered individually and as an ordered
combination, provides an inventive concept sufficient to transform the
natural law into a patent-eligible application.
Appellant also misapprehends the controlling precedent to the extent
Appellant maintains that claim 1 is patent eligible because it allegedly is
novel and non-obvious in view of the cited prior art. See Reply Br. 6–7
(arguing that the Examiner has failed to show that the applied art discloses
or suggests the claimed subject matter). Neither a finding of novelty nor a
non-obviousness determination automatically leads to the conclusion that the
claimed subject matter is patent eligible. Although the second step in the
Mayo/Alice framework is termed a search for an “inventive concept,” the
analysis is not an evaluation of novelty or non-obviousness, but rather, a
search for “an element or combination of elements that is ‘sufficient to
ensure that the patent in practice amounts to significantly more than a patent
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upon the [ineligible concept] itself.’” Alice, 573 U.S. at 217–18 (citation
omitted) (alteration in original). “Groundbreaking, innovative, or even
brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for
Molecular Pathology, 569 U.S. at 591. A novel and non-obvious claim
directed to a judicial exception is, nonetheless, patent ineligible. See Mayo,
566 U.S. at 90; see also Diamond v. Diehr, 450 U.S. 175, 188–89 (1981)
(“The ‘novelty’ of any element or steps in a process, or even of the process
itself, is of no relevance in determining whether the subject matter of a claim
falls within the § 101 categories of possibly patentable subject matter.”).

Conclusion
We are not persuaded, on the present record, that the Examiner erred
in rejecting independent claim 1 under 35 U.S.C. § 101. Therefore, we
sustain the Examiner’s rejection of claim 1, and claims 2–12, 16–27, 31–34,
36, 40, and 41, which fall with claim 1.

III. Obviousness of Claims 1, 2, 4, 5, 8–15, 17, 18, 20, 21, 23–30,
and 33–41 over Drew and Virag
We are persuaded by Appellant’s argument that the Examiner erred in
rejecting independent claims 1, 17, 33, and 36, because the combination of
Drew and Virag fails to teach or suggest the claimed “biomarker,” which
“indicates [that] a response of the patient to the therapy delivered by the
medical device according to the therapy program may have changed relative
to a response of the patient to the therapy delivered by the medical device
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according to the therapy program when the patient was in a baseline state in
which efficacious therapy delivery by the medical device according to the
therapy program was observed,” as recited in claim 1, and similarly recited
in claims 17, 33, and 36.
In rejecting claim 1, the Examiner relies on Drew as teaching the step
of “determining . . . whether the bioelectrical brain signal includes a
biomarker.” Final Act. 6 (citing Drew ¶¶ 70, 79, 81). The Examiner
acknowledges that Drew does not teach the step of selecting the biomarker.
Id. at 7. However, the Examiner finds that Virag teaches this aspect of the
claim language. Id. at 8 (citing Virag ¶ 84). The Examiner makes similar
findings with respect to independent claims 17, 33, and 36. See id. at 13–14.
Drew relates to selecting, storing, and reporting data associated with
physiologic signals that may be further associated with a neurological event.
Drew ¶ 2. Drew teaches sensing and measuring an electroencephalogram to
detect a seizure. Id. ¶ 70. Specifically, a calculation is performed based on
the measurement data to determine the occurrence of a seizure. Id. ¶ 79,
Fig. 11. If no seizure is detected, the method continues to sense and measure
the electroencephalogram. Id. However, if a seizure is detected, the method
determines a type of therapy and duration of therapy to deliver. Id. ¶¶ 79–
80, Fig. 11. Once the therapy is complete, the method returns to monitoring
brain signal parameters. Id. ¶ 80, Fig. 11.
Thus, Drew teaches monitoring a patient’s brain signals to determine
if the brain signals indicate a seizure, and delivering therapy when it is
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determined that a seizure occurs. But Drew does not teach or suggest the
use of a biomarker that “indicates a response of the patient to the therapy
delivered by the medical device according to the therapy program may have
changed relative to a response of the patient to the therapy program when the
patient was in a baseline state in which efficacious therapy was delivered by
the medical device according to the therapy program was observed,” as
required by the steps of “selecting” and “determining” in claim 1. Put
another way, the patient in Drew does not receive therapy during the
monitoring of the patient’s brain signals. Because therapy is not delivered to
the patient while the brain signals are received, the received brain signals do
not and cannot include information regarding the patient’s response to such
therapy (i.e., that the patient’s response to the therapy may have changed).
Instead, Drew teaches monitoring brain signals for the occurrence of a
seizure, providing treatment when it occurs, and resuming monitoring after
treatment.
Virag does not cure the deficiencies of Drew. Virag relates to
detecting and/or treating nervous system disorders, such as seizures, in a
patient with an implantable medical device. Virag ¶ 2. Virag teaches
identifying a “precursor” to a neurological event, such as an epileptic
seizure. Id. ¶ 84. The technique involves keeping track of when a signal
amplitude of a brain signal transitioning from one range to another. Id.; see
also id. ¶ 86. By identifying a precursor to a seizure, rather than the seizures
themselves, Virag’s invention allows more time “to charge stimulation
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circuitry needed for therapy delivery” or “for the delivery of preliminary
therapy that may be able to prevent or lessen the severity of a subsequent
seizure.” Id. ¶ 85. Thus, Virag involves preparing for a seizure or
delivering a preliminary therapy in response to detecting a precursor to a
seizure. But, similar to the embodiment described in Drew, no therapy is
provided as the patient’s brain signals are received. As such, the patient’s
monitored brain signals would not include information regarding the
patient’s response to therapy (i.e., that the patient’s response to the therapy
may have changed from when the patient was in a baseline state in which
efficacious therapy was observed to be delivered).
Accordingly, we do not sustain the rejection of claims 1, 2, 4, 5, 8–15,
17, 18, 20, 21, 23–30, and 33–41 under 35 U.S.C. § 103(a) as unpatentable
over the teachings of Drew and Virag.

IV. Obviousness of Claims 1, 2, 6, 8, 13–15, 17, 18, 22, 23, 28–30, 33,
and 35–41 over Drew and Dilorenzo
The Examiner concludes that the subject matter of claims 1, 2, 6, 8,
13–15, 17, 18, 22, 23, 28–30, 33, and 35–41 would have been obvious from
the combined teachings of Drew and Dilorenzo. Final Act. 14–18; Ans. 5–7.
In this rejection, the Examiner relies on Dilorenzo rather than Virag as
disclosing the selecting step. Final Act. 16 (citing Dilorenzo ¶¶ 97, 100).
Dilorenzo describes implantable medical device 12 for notifying a
patient or caregiver of the onset of epileptic seizures. Dilorenzo ¶¶ 16, 76,
Figs. 3A–4. Dilorenzo monitors neural signals from a patient during an
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observation window. Id. ¶ 90. The measured signals are input into a
predictive algorithm to extract one or more features from the signals, which
are then classified to characterize the patient’s propensity for a seizure.
Dilorenzo ¶ 91. Classification may include comparing the extracted features
to historical or baseline features values. Id. ¶ 100. Exemplary extracted
features include beta band power and gamma band power. Id. ¶¶ 96–97.
After characterizing the patient’s propensity for seizure, the method
determines if any action is needed and, if so, a treatment algorithm is used to
determine an appropriate treatment for the patient. Id. ¶ 92.
The Examiner finds that Dilorenzo’s extracted features from the
patient signals teach the claimed biomarker. Ans. 6 (citing Spec. ¶ 72).
However, this finding suffers similar shortcomings to those described above
with respect the rejection over Drew and Virag. Specifically, Dilorenzo
describes extracting features from patient signals to determine whether a
patient should receive treatment. See Dilorenzo ¶ 92. However, Dilorenzo
does not teach receiving the patient signals while the patient receives
therapy, much less that the extracted features would indicate that:
a response of the patient to the therapy delivered by the medical
device according to the therapy program may have changed
relative to a response of the patient to the therapy delivered by
the medical device according to the therapy program when the
patient was in a baseline state in which efficacious therapy
delivery by the medical device according to the therapy program
was observed,
as required by claim 1. Appeal Br. 40–41.
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Accordingly, we do not sustain the rejection of claims 1, 2, 6, 8, 13–
15, 17, 18, 22, 23, 28–30, 33, and 35–41 under 35 U.S.C. § 103(a) as
unpatentable over the teachings of Drew and Dilorenzo.

V. Remaining Rejections
Each of the remaining rejections is based in part on the previous
combination of Drew and Virag, or Drew and Dilorenzo. Final Act. 19–22;
Ans. 9–10. The Examiner does not rely on the additional references to
correct the deficiencies of those combinations. Consequently, we do not
sustain those rejections under U.S.C. § 103(a).

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CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
40, 41 112, fourth
paragraph
Improper
Dependency
40, 41
1–12, 16–
27, 31–34,
36, 40, 41
101 Ineligibility 1–12, 16–
27, 31–34,
36, 40, 41

1, 2, 4, 5,
8–15, 17,
18, 20, 21,
23–30, 33–
41
103(a) Drew, Virag 1, 2, 4, 5,
8–15, 17,
18, 20, 21,
23–30, 33–
41
1, 2, 6, 8,
13–15, 17,
18, 22, 23,
28–30, 33,
35–41
103(a) Drew, Dilorenzo 1, 2, 6, 8,
13–15, 17,
18, 22, 23,
28–30, 33,
35–41
3, 19 103(a) Drew, Virag,
Lange
3, 19
3, 19 103(a) Drew, Dilorenzo,
Lange
3, 19
16, 31 103(a) Drew, Virag,
Osorio ʼ407,
Osorio ʼ119
16, 31
16, 31, 32 103(a) Drew, Dilorenzo,
Osorio ʼ407,
Osorio ʼ119
16, 31, 32
Overall
Outcome
1–12, 16–
27, 31–34,
36, 40, 41
13–15, 28–
30, 35, 37–
39

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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 IN PART