Mark T. Rise et al.

Patent Trials and Appeals Board

Jan 13, 2020

12425758 - (D) (P.T.A.B. Jan. 13, 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.
12/425,758 04/17/2009 Mark T. Rise 1023-778US01/
P0031776.01
3326
71996 7590 01/13/2020
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
WU, TONG E
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
01/13/2020 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):
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 MARK T. RISE AND JONATHON E. GIFTAKIS
__________

Appeal 2018-008502
Application 12/425,758
Technology Center 3700
__________

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
ROBERT A. POLLOCK, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–7, 12–16, 18–23, 25–29, 35–42, and
44–59. 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 states that “[t]he real parties in interest are
Medtronic Inc. of Minneapolis, Minnesota, the assignee of record, and
Medtronic plc of Dublin, Ireland, the ultimate parent entity of Medtronic
Inc.” Appeal Br. 3 (entered February 26, 2018).
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STATEMENT OF THE CASE
This application has been before this Board previously, in Appeal
2012-011101. See Decision entered September 18, 2015; Decision on
Reconsideration entered December 21, 2015.
In the present appeal, the following rejections are before us for
review:2
(1) Claims 42, 52, 53, 57 and 58, under 35 U.S.C. § 112, second
paragraph, as being indefinite (Final Act. 13–14);3
(2) Claims 52 and 57, under 35 U.S.C. § 112, fourth paragraph, as
being of improper dependent form (Final Act. 14–15);
(3) Claims 1–7, 12–16, 18–23, 25–29, 35–42, and 44–59, under 35
U.S.C. § 101 as being directed to subject matter ineligible for patenting
(Final Act. 18–19); and
(4) Claims 22, 23, and 25, under 35 U.S.C. § 102(b) as being
anticipated by Morrell4 (Final Act. 19–21);
(75) Claims 1–4, 6, 7, 12–16, 19–23, 25–29, 35–42, and 44–59, under
35 U.S.C. § 103(a) as being unpatentable over Morrell (Final Act. 21–32);
(6) Claim 5, under 35 U.S.C. § 103(a) as being unpatentable over
Morrell and Hamilton5 (Final Act. 32–33); and
(7) Claim 18, under 35 U.S.C. § 103(a) as being unpatentable over
Morrell and Tadlock6 (Final Act. 33).

2 The Examiner withdrew a number of rejections in the Examiner’s Answer.
See Ans. 2 (entered June 28, 2018).
3 Final Action entered August 24, 2017.
4 US 2006/0058856 A1 (published Mar. 16, 2006).
5 Max Hamilton, A Rating Scale for Depression, 23 J. NEUROL. NEUROSURG.
PSYCHIAT. 56-62 (1960).
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Claims 1, 22, 26, and 42 are the independent claims on appeal. See
Appeal Br. 49–63. Claims 1 and 22 illustrate the subject matter on appeal
and read as follows:
Claim 1: A method of identifying target tissue sites, the method
comprising:
determining, with a processor, a first patient symptom
and a second patient symptom of a patient, wherein the first
patient symptom differs from the second patient symptom;
selecting, with the processor, a first target tissue site
within the patient for psychiatric disorder therapy delivery
based on the first patient symptom;
selecting, with the processor, a second target tissue site
within the patient for the psychiatric disorder therapy delivery
based on the second patient symptom, wherein the second
target tissue site is different than the first target tissue site;
establishing, with the processor and based on at least one
of a severity, a duration, or a type of the first patient symptom,
a first weighting factor for the first target tissue site;
establishing, with the processor and based on at least one
of a severity, a duration, or a type of the second patient
symptom, a second weighting factor for the second target tissue
site; and
controlling, by the processor, a medical device to deliver
the psychiatric disorder therapy to the first and second target
tissue sites substantially simultaneously according to the
respective weighting factors, wherein, for each of the first and
second target tissue sites, the corresponding weighting factor
indicates at least one of:
an intensity of therapy to be delivered to the
respective target tissue site when the medical device
delivers the psychiatric disorder therapy to the first and
second target tissue sites substantially simultaneously,

6 US 2006/0136008 A1 (published June 22, 2006).
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a frequency of therapy to be delivered to the
respective target tissue site when the medical device
delivers the psychiatric disorder therapy to the first and
second target tissue sites substantially simultaneously, or
a therapy program according to which therapy is to
be delivered to the respective target tissue site when the
medical device delivers the psychiatric disorder therapy
to the first and second target tissue sites substantially
simultaneously.

Claim 22: A method comprising:
selecting a first target tissue site within a patient for
psychiatric disorder therapy delivery;
selecting a second target tissue site within the patient for
the psychiatric disorder therapy delivery;
establishing, with a processor and based on a severity, a
duration, or a type of a first patient symptom, a first weighting
factor for the first target tissue site;
establishing, with the processor and based on a severity, a
duration, or a type of a second patient symptom, a second
weighting factor for the second target tissue site; and
controlling, by the processor, a medical device to deliver
the psychiatric disorder therapy delivery to the first and second
target tissue sites according to the respective weighting factors,
wherein, for each of the first and second target tissue
sites, the corresponding weighting factor indicates at least one
of:
an intensity of therapy to be delivered to the
respective target tissue site when the medical device
delivers the psychiatric disorder therapy to the first and
second target tissue sites substantially simultaneously,
a frequency of therapy to be delivered to the
respective target tissue site when the medical device
delivers the psychiatric disorder therapy to the first and
second target tissue sites substantially simultaneously, or
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a therapy program according to which therapy is to
be delivered to the respective target tissue site when the
medical device delivers the psychiatric disorder therapy
to the first and second target tissue sites substantially
simultaneously.
Id. at 49–50, 54.
INDEFINITENESS—CLAIM 42
The Examiner’s Rejection
The Examiner determined that the recitations of “means for
determining, selecting, and establishing” in claim 42 are indefinite because
“it is unclear what are the corresponding structures in the [S]pecification.”
Final Act. 13.
In particular, the Examiner determined that the Specification discloses
only “general neurostimulation hardware and functional boxes (Figures 1-4),
which do not identify any specific structures responsible for the functions.”
Id. The Examiner reasoned, therefore, that a skilled artisan would not
understand from the Specification what specific structures perform the
functions recited in claim 42. Id. (citing MPEP § 2181(II)(A)).
The Examiner also determined that the Specification did not include
any specific instructions or algorithms describing how to program a
processor to perform the functions recited in claim 42, contrary to the
requirements set forth in MPEP § 2181(II)(B). Id. at 13–14.
The Examiner further determined that the Specification did not clearly
link or associate any specific structure with any of the particular functions
recited in claim 42, contrary to the requirements set forth in MPEP
§ 2181(II)(C). Id. at 14.
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Analysis
Terms recited using means plus function language are indefinite when
the Specification does not provide specific structures or algorithms for
performing the functions associated with the claimed means. Ex parte
Rodriguez, 92 USPQ2d 1395, 1400–1403 (BPAI 2009) (precedential).
In the present case, claim 42 recites “[a] system.” Appeal Br. 59.
The language at issue in claim 42 identified by the Examiner recites the
following components of the claimed system:
[a] means for determining a first patient symptom and a
second patient symptom of a patient, wherein the first patient
symptom differs from the second patient symptom;
[a] means for selecting a first target tissue site for
psychiatric disorder therapy delivery based on the first patient
symptom;
[a] means for selecting a second target tissue site for the
psychiatric disorder therapy delivery based on the second
patient symptom, wherein the second target tissue site is
different than the first target tissue site;
[a] means for establishing, based on a severity, a
duration, or a type of the first patient symptom, a first
weighting factor for the first target tissue site; [and]
[a] means for establishing, based on a severity, a
duration, or a type of the second patient symptom, a second
weighting factor for the second target tissue site.
Id.
Appellant does not persuade us that the Examiner erred in determining
that the Specification fails to provide specific structures or algorithms for
performing the functions associated with the means quoted above.
As seen above, the means in claim 42 identified by the Examiner are
recited as performing five distinct and specific functions: (1) “determining a
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first patient symptom and a second patient symptom of a patient, wherein the
first patient symptom differs from the second patient symptom;” (2)
“selecting a first target tissue site for psychiatric disorder therapy delivery
based on the first patient symptom;” (3) “selecting a second target tissue site
for the psychiatric disorder therapy delivery based on the second patient
symptom, wherein the second target tissue site is different than the first
target tissue site;” (4) “establishing, based on a severity, a duration, or a type
of the first patient symptom, a first weighting factor for the first target tissue
site;” and (5) “establishing, based on a severity, a duration, or a type of the
second patient symptom, a second weighting factor for the second target
tissue site.” Appeal Br. 59.
Appellant asserts that the Specification clearly links or associates the
structures, materials, or acts that correspond to the functions recited in claim
42, and cites a number of portions of the Specification in support of that
assertion. Appeal Br. 22–24 (citing Spec. ¶¶ 132, 149–151, 153, 159; Figs.
5–11); Reply Br. 3–4.
None of the portions of the Specification cited by Appellant, however,
clearly or expressly states that the disclosures therein are intended to
describe structures or algorithms corresponding to any particular “means.”
Appellant, moreover, does not explain with any specificity which of the
identified disclosures corresponds to which specific function recited in claim
42. Nor does Appellant explain specifically how or why any of the
identified disclosures corresponds to any of the specific functions at issue
recited in claim 42 and identified by the Examiner.
Given the absence of a specific or detailed explanation as to how and
why there is a linkage between the means plus function language identified
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by the Examiner and the portions of the Specification and drawings cited by
Appellant, we are not persuaded that Appellant has shown Examiner error in
this instance. Indeed, in the arguments traversing the Examiner’s rejection,
Appellant does not state expressly or specifically which particular structures
or components disclosed in the cited drawings and portions of the
Specification are contemplated as corresponding to the means recited in
claim 42.
We note that all of the portions of the Specification cited by Appellant
refer to processors that perform certain described functions. See Appeal Br.
23–24 (processors 40, 34, and 70 disclosed in Spec. ¶¶ 132, 149–151, 153,
and 159 cited by Appellant). To the extent Appellant argues that the
disclosed processors correspond to the means at issue, claim 42 is directed to
a computer-implemented invention. To avoid a conclusion of indefiniteness,
the Specification must include an algorithm for performing each of the
means identified by the Examiner as lacking support in the Specification.
See Aristocrat Techs. Austl. Pty Ltd. v. Inter. Game Tech., 521 F.3d 1328,
1333–34, 1338 (Fed. Cir. 2008).
In that regard, Appellant contends that its “disclosure includes
numerous flowcharts and tables describing the algorithm to be performed
including, for example, the flowcharts and tables shown in Figures 5–11.”
Appeal Br. 23; Reply Br. 3. Again, however, Appellant does not provide a
specific or detailed explanation as to which particular flowchart or table in
which particular figure provides an algorithm that corresponds to a particular
function in claim 42 identified by the Examiner. We are not persuaded,
therefore, that Appellant has shown error in the Examiner’s determination
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that the Specification only provides a generalized disclosure inadequate to
support the means plus function recitations at issue.
We acknowledge that the first two means in claim 42 identified by the
Examiner as being indefinite are means for determining first and second
patient symptoms. See Appeal Br. 59. We further acknowledge that certain
portions of the Specification cited by Appellant include examples of criteria
for determining a patient symptom, such as the “number of symptom
indications within a particular time frame” (Spec. ¶ 149), “activity level” (id.
¶¶ 150, 152), and “sleep quality” (id. ¶ 153). Appellant, however, does not
identify a specific algorithm, i.e., a finite sequence of steps that employs
those criteria in determining a patient symptom, as recited in claim 42.
The fact that a skilled artisan might be able to devise an algorithm that
uses the criteria identified in the Specification to determine a patient
symptom does not demonstrate that the Specification adequately describes
the specific means for determining a patient symptom recited in claim 42.
See Aristocrat, 521 F.3d at 1337 (“The inquiry is whether one of skill in the
art would understand the specification itself to disclose a structure, not
simply whether that person would be capable of implementing that
structure.”) (quoting Biomedino, LLC v. Waters Technologies Corp., 490
F.3d 946, 953 (Fed. Cir. 2007)).
The Examiner also rejected as indefinite the means for selecting first
and second target tissue sites for psychiatric disorder therapy delivery based
on the first and second patient symptoms. Final Act. 13–14.
We acknowledge that Appellant’s Figures 6 and 9 list target tissue
sites that correspond to patient symptoms and mood states. See Figs. 6, 9.
We acknowledge the statement in the Specification that “[p]rocessor 70
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determines the target tissue sites and the respective weighting factors.”
Appeal Br. 24 (quoting Spec. ¶ 132). Again, however, the fact that a skilled
artisan might be able to devise an algorithm that uses the criteria identified
in the drawings and Specification to select a target tissue does not
demonstrate that the Specification adequately describes the specific means
for performing that function. See Aristocrat, 521 F.3d at 1337.
The Examiner also rejected claim 42 as indefinite based on the
recitation of means for establishing first and second weighting factors for the
target tissue sites, based on the severity, duration, or type of the first and
second symptoms. See Final Act. 13–14.
Although not identified specifically by Appellant, the flow chart in
Figure 5 includes a step entitled “ESTABLISH WEIGHTING FACTORS
FOR TARGET TISSUE SITES BASED ON SYMPTOM INFORMATION”
and the flow chart in Figure 10 includes a step entitled “ESTABLISH
WEIGHTING FACTORS FOR TARGET TISSUE SITES BASED ON
MOOD STATE INFORMATION.” Figs. 5, 10. Thus, at best, Figures 5
and 10 simply restate the function to be performed, without providing an
actual algorithm that achieves that function.
Similarly, ¶¶ 132 and 159 of the Specification identified by Appellant
state that processor 70 determines weighting factors, including by the
technique shown in Figure 10. See Appeal Br. 24. Appellant, however,
identifies no disclosure in the Specification of any specific algorithm used
by the processor to determine the weighting factors. Again, therefore, rather
than providing an actual algorithm that performs the function of establishing
a weighting factor, the cited portions of the Specification merely restate the
function to be performed.
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In sum, we have carefully reviewed the drawings and portions of the
Specification cited by Appellant as providing structures corresponding to the
“means for” elements rejected by the Examiner as being indefinite. For the
reasons discussed above, Appellant does not persuade us that the Examiner
erred in concluding that claim 42 is indefinite based on the means plus
function recitations. We therefore affirm the Examiner’s rejection of claim
42 for indefiniteness.
INDEFINITENESS—CLAIMS 52 AND 57
The Examiner’s Rejection
The Examiner’s rejection of claims 52 and 57 for indefiniteness, in its
entirety, states that “[i]t is unclear how rephrasing the weighting factors to
be weighting ‘coefficients’ affects the scope.” Final Act. 14.
Subsequently, in response to Appellant’s arguments, the Examiner
explains further:
[T]o explain the basis of the rejection, if we consider the plain
meaning of the terms recited, a “weighting factor” is going to
be some value that modulates the therapy. A “weighting
coefficient” is, likewise, going to be some value that modulates
the therapy. There does not appear to be a discernible
difference in scope.
Ans. 11.
Analysis
The Supreme Court has stated that “a patent is invalid for
indefiniteness if its claims, read in light of the specification delineating the
patent, and the prosecution history, fail to inform, with reasonable certainty,
those skilled in the art about the scope of the invention.” Nautilus, Inc. v.
Biosig, Insts., Inc., 572 U.S. 898, 901 (2014) (internal quotations omitted);
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see also id. at 910 (“The definiteness requirement, so understood, mandates
clarity, while recognizing that absolute precision is unattainable.”).
In the present case, we are not persuaded that the Examiner has shown
that skilled artisans would not understand the scope of the language at issue.
Claim 52 recites “[t]he method of claim 1, wherein the weighting
factors are weighting coefficients.” Appeal Br. 62. Claim 57 depends from
claim 26 (which essentially recites a system configured to perform the
process of claim 1), and also recites that the weighting factors are weighting
coefficients. Id. at 63.
As seen above, the Examiner concedes that a skilled artisan would
understand that “coefficient” means “[a] value that modulates the therapy.”
Ans. 11.
Thus, rather than establishing that skilled artisans would not
understand the scope of the language at issue, the Examiner at best has
shown only that the disputed language is relatively broad. It is well settled,
however, that “breadth is not to be equated with indefiniteness.” In re
Miller, 441 F.2d 689, 693 (CCPA 1971). Accordingly, we reverse the
Examiner’s rejection of claims 52 and 57 for indefiniteness.
INDEFINITENESS—CLAIMS 53 AND 58
The Examiner’s Rejection
In rejecting claims 53 and 58 for indefiniteness, the Examiner stated
that it is “unclear how a weighting factor that indicates an intensity would be
different in scope than a weighting factor that indicates a ‘relative’ intensity,
since the term ‘weighting factor’ itself connotes some degree of relativity.”
Final Act. 14. The Examiner concluded, in addition, that “a ‘relative’
intensity is indefinite, since there is no context for what it is relative to.” Id.
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Analysis
Claim 53 recites:
The method of claim 1, wherein, for one of the first and
second target tissue sites, the corresponding weighting factor
indicates the intensity of therapy to be delivered to the
corresponding target tissue site, the intensity being indicated as
a relative intensity of stimulation to be delivered at the one of
the first and second target tissue sites.
Appeal Br. 62 (emphasis added). Claim 58 is identical to claim 53, except
that claim 58 depends from claim 26. Id. at 63.
We are not persuaded that the Examiner has shown that skilled
artisans would not understand the scope of the language at issue. As seen
above, claims 53 and 58 expressly state that the intensity of stimulation to be
delivered to a target site must be indicated as a relative intensity of
stimulation “delivered at one of the first and second target tissue sites.”
Appeal Br. 62, 63.
Contrary to the Examiner’s conclusion, therefore, claims 53 and 58
expressly state the basis for indicating the relative intensity. Accordingly,
because we are not persuaded that the Examiner has explained adequately
why a skilled artisan would fail to understand the scope of claims 53 and 58,
we reverse the Examiner’s rejection of claims 53 and 58 for indefiniteness.
35 U.S.C. § 112, FOURTH PARAGRAPH
The Examiner’s Rejection
The Examiner rejected claims 52 and 57 under 35 U.S.C. § 112,
fourth paragraph. Final Act. 15. In this rejection, the Examiner stated that,
“[a]s noted above, the claim does not further limit the subject matter.” Final
Act. 15. As noted above, in explaining the rejection of claims 52 and 57 for
indefiniteness, the Examiner determined that “a ‘weighting factor’ is going
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to be some value that modulates the therapy. A ‘weighting coefficient’ is,
likewise, going to be some value that modulates the therapy. There does not
appear to be a discernible difference in scope.” Ans. 11.
Analysis
The fourth paragraph of section 112 states, in relevant part, that “a
claim in dependent form shall contain a reference to a claim previously set
forth and then specify a further limitation of the subject matter claimed.”
As noted above, claim 52 recites “[t]he method of claim 1, wherein
the weighting factors are weighting coefficients” and claim 57 reads
identically except that it depends from claim 26. Appeal Br. 62, 63.
As noted above, claim 1 recites the use of “weighting factors” in the
claimed process, and claim 26 recites a system configured to use “weighting
factors” in a process similar to that recited in claim 1. Id. at 49, 56.
As noted above, the Examiner contends that, when given their
broadest reasonable interpretation consistent with the Specification, the
terms “weighting factor[s]” and “weighting coefficient[s]” mean the same
thing: a “value that modulates the therapy.” Ans. 11.
Appellant contends that the Specification uses weighting factors and
weighting coefficients in a manner demonstrating clearly that weighting
coefficients are narrower in scope than weighting factors, and that the
Examiner therefore unreasonably interprets weighting factors and weighting
coefficients as meaning the same thing. See Appeal Br. 25 (citing Spec.
¶ 41); Reply Br. 5 (citing Spec. ¶¶ 125, 132); Reply Br. 8). We are not
persuaded.
We note the Specification’s disclosure that “[w]eighting factors may
be, for example, weighting variables or weighting coefficients that control
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therapy.” Spec. ¶ 41. We also note the Specification’s disclosure that the
“weighting factors may be used to control therapy delivery.” Id. ¶ 125; see
also id. ¶ 132 (therapy delivery to the target tissue sites may be controlled
“based on the respective weighting factors”).
Appellant, however, does not explain specifically how or why the
context of the usages of weighting factors and coefficients identified in the
Specification demonstrates that a skilled artisan would have understood
those terms to have different meanings. Nor does Appellant identify in the
Specification, or anywhere else in the record, a specific definition of either a
weighting factor or a weighting coefficient that demonstrates error or
unreasonableness in the Examiner’s determination that a skilled artisan
would understand those terms to both mean the same thing—a value that
modulates the therapy. Indeed, according to the Specification, and
consistent with the Examiner’s determination, weighting factors and
weighting coefficients perform the same function: controlling (i.e.,
modulating) therapy. See Spec. ¶¶ 41, 125, 132.
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in determining that claims 52 and 57 fail to further limit
the claims from which they depend. We therefore affirm the Examiner’s
rejection of claims 52 and 57 under § 112, fourth paragraph.
ELIGIBILITY FOR PATENTING—35 U.S.C. § 101
The Examiner’s Rejection
The Examiner rejected claims 1–7, 12–16, 18–23, 25–29, 35–42, and
44–59 (all of the pending claims), under 35 U.S.C. § 101 as being directed to
subject matter ineligible for patenting. Final Act. 18–19. The Examiner
determined that “(1) detecting symptoms, (2) selecting appropriate target
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tissue sites, and (3) establishing weighting factors for individual target sites
. . . are essentially the steps to any standard medical treatment protocol (i.e.
observe symptoms, target the problem, treat appropriately), and as such,
constitute the abstract idea.” Id. at 18.
The Examiner then determined that Appellant’s claims do not include
additional elements that amount to “significantly more than the judicial
exception because further describing routine and conventional types of
symptoms, types of target tissues, and different forms of potential therapy
merely provide further context in which the abstract idea is practiced,
without further specifying any particular solution to the problem.” Id.
Principles of Law
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101. The
Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit
exceptions, however: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patentable. Alice, 573 U.S. at 216.
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
Collaborative Services v. Prometheus Laboratories., Inc., 566 U.S. 66
(2012) and Alice, 573 U.S. at 217–18 (citing Mayo, 566 U.S. at 75–77). In
accordance with that framework, we first determine what concept 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.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
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economic practices (Alice, 573 U.S. at 219–20; Bilski v. Kappos, 561 U.S.
593, 611 (2010)); mathematical formulas (Parker v. Flook, 437 U.S. 584,
594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63,
69 (1972)).
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).
Early in 2019, the PTO published revised guidance on the application
of § 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance,
84 Fed. Reg. 50 (January 7, 2019) (“Memorandum” or “2019 Office
Guidance” or “Office Guidance”).7 In light of comments received in
response to the Office Guidance, the PTO subsequently issued the October
2019 Patent Eligibility Guidance Update (“October 2019 Update”).8
Following the Office Guidance and the October 2019 Update, under
Revised Step 2A, we first look to whether the claim recites the following:
(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)).

7 Available at https://www.govinfo.gov/content/pkg/FR-2019-01-
07/pdf/2018-28282.pdf.
8 https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_
update.pdf.
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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 of the
Office Guidance, to whether the claim:
(3) adds specific limitations beyond the judicial exception that
are 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.
See Memorandum.
Analysis
Office Guidance—Revised Step 2A, Prong 1
Claim 1 is illustrative for the purposes of our eligibility analysis.
Claim 1 recites “[a] method of identifying target tissue sites.” Appeal Br.
49.
As discussed below, however, claim 1 also recites a step of
controlling a medical device to deliver psychiatric disorder therapy to first
and second target tissue sites substantially simultaneously according to
weighting factors established by analyzing patient symptoms. See id. Thus,
despite the preamble’s stated purpose of the claimed process, claim 1
actually recites a method of delivering psychiatric disorder therapy. Id.
Applying Revised Step 2A, Prong 1, of the 2019 Office Guidance, we
agree with the Examiner that Appellant’s claim 1 recites abstract ideas in a
number of instances. Specifically, although claim 1 recites the use of a
processor, each of the claimed steps of determining first and second patient
symptoms, selecting first and second tissue sites for psychiatric therapy
delivery based on the symptoms, and establishing weighting factors for the
target tissue site based on the symptoms, can be performed in the human
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mind, and therefore are mental processes that constitute abstract ideas. See
Office Guidance (84 Fed. Reg. at 52 (abstract ideas include “(c) Mental
processes—concepts performed in the human mind (including an
observation, evaluation, judgment, opinion”) (citations omitted); see also id.
n.14 (“If a claim, under its broadest reasonable interpretation, covers
performance in the mind but for the recitation of generic computer
components, then it is still in the mental processes category unless the claim
cannot practically be performed in the mind.”) (citing Intellectual Ventures I
LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016)))).
Office Guidance—Revised Step 2A, Prong 2
Having determined that Appellant’s claim 1 recites abstract ideas
under Revised Step 2A, Prong 1, of the 2019 Office Guidance, we turn to
Revised Step 2A, Prong 2, of the Office Guidance to determine whether
claim 1 recites additional elements that integrate the judicial exceptions into
a practical application. See Office Guidance (84 Fed. Reg. at 54–55).
In this instance, we find that Appellant’s claim 1 recites additional
elements sufficient to integrate the judicial exceptions into a practical
application. Specifically, as noted above, claim 1 recites a step of
controlling a medical device to deliver psychiatric disorder therapy to first
and second target tissue sites substantially simultaneously according to the
weighting factors established by analyzing patient symptoms. Appeal Br.
49.
Because claim 1 recites a treatment for a specific type of disorder
(psychiatric disorder therapy), performed in a specific manner (directly to
two different target tissue sites), according to a specific regimen
(substantially simultaneously), we find that Appellant’s claim 1 recites
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additional elements sufficient to integrate the judicial exceptions recited in
the claim into a practical application. See Office Guidance (84 Fed. Reg. at
55) (example of additional element that integrates a judicial exception into a
practical application includes “an additional element that applies or uses a
judicial exception to effect a particular treatment or prophylaxis for a disease
or medical condition”) (citing Classen Immunotherapies, Inc. v. Biogen
IDEC, 659 F.3d 1057, 1066–68 (Fed. Cir. 2011); Vanda Pharm. Inc. v.
West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1135 (Fed. Cir. 2018)).
Eligibility Conclusion
Because we find that claim 1 integrates the abstract ideas recited in
the claim into a practical application, we are not persuaded that claim 1
recites subject matter ineligible for patenting. We therefore reverse the
Examiner’s rejection of claim 1, and its dependent claims, on that ground.
As to the remaining independent claims, claim 22 recites a process
that, similar to claim 1, delivers psychiatric disorder therapy to two distinct
target tissue sites, and claims 26 and 42 recite systems that include devices
configured to deliver psychiatric disorder therapy simultaneously to two
distinct tissue sites according to the weighting factors established by
analyzing patient symptoms. See Appeal Br. 54–56, 59–60. Accordingly,
for essentially the same reasons discussed as to claim 1, we also reverse the
Examiner’s rejections of claims 22, 26, 42, and their dependent claims, on
the ground of ineligibility for patenting.
ANTICIPATION
The Examiner’s Rejection
The Examiner rejected claims 22, 23, and 25 as anticipated by
Morrell. Final Act. 19–21. As to claim 22, the independent claim subject to
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this rejection, the Examiner cited Morrell as describing the selection of a
number of first and second tissue sites for psychiatric disorder therapy
delivery, as well the establishment of weighting factors for those target
tissues, as recited in the claim. Id. at 19–20.
The Examiner cited Morrell as describing claim 22’s delivery of the
psychiatric disorder therapy “to the first and second target tissue sites via a
medical device (Figure 1; abstract; Paragraphs 22, 23) according to the
weighting factors. No relationship between weighting factors is recited, and
each and any stimulation can be considered to have a weighting factor
associated with it.” Id. at 20.
The Examiner determined that, in claim 22, “[t]he phrase ‘when a
medical device delivers the psychiatric disorder therapy to the first and
second target tissue sites substantially simultaneously’ merely modifies a
context in which the weighting factors are defined and does not directly
require delivering therapy to the first and second target tissue sites
substantially simultaneously.” Id.
Analysis
We are not persuaded that the Examiner has shown that Morrell
describes a process that has all of the features required by claim 22. As seen
above, the Examiner concludes that claim 22 does not require simultaneous
delivery of psychiatric disorder therapy to two different tissue sites, and
therefore does not identify any disclosure in Morrell in which the described
device delivers therapy to two distinct target tissue sites simultaneously.
Indeed, as seen below in the discussion of the Examiner’s obviousness
rejection, the Examiner concedes that “Morrell does not explicitly disclose
the combination of delivering therapy to first and second tissue sites
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simultaneously.” Final Act. 23; see also Ans. 17 (“[A]ccording to the claim,
the weighting factors are established based on the corresponding symptom.
The weighting factors will assume their established values and indicate the
associated effect on therapy (intensity, frequency, program) regardless of
whether therapy is actually delivered simultaneously or not.”).
We are not persuaded, however, that the Examiner’s interpretation of
claim 22 is reasonable. In particular, we agree with Appellant that the
language of claim 22 necessarily requires the medical device to include a
configuration that delivers psychiatric disorder therapy simultaneously to
two different tissue sites. See Appeal Br. 54.
Specifically, claim 22 recites a process in which a medical device
delivers psychiatric disorder therapy to first and second target tissue sites.
Appeal Br. 54. Claim 22 recites that the therapy is delivered according to
weighting factors that are based on the severity, duration, or type, of two
symptoms of a patient (first and second symptoms). Id.
As Appellant points out, claim 22 recites that the weighting factors
must indicate either an intensity, a frequency, or a therapy program “to be
delivered to the respective target tissue site when the medical device delivers
the psychiatric disorder therapy to the first and second target tissue sites
substantially simultaneously.” Id.
Thus, for the weighting factors in claim 22 to indicate the intensity,
frequency, or therapy program to be delivered to the target tissue when the
medical device delivers the therapy to the first and second target sites
simultaneously, the device necessarily must at least include a configuration
that delivers psychiatric disorder therapy simultaneously to two different
tissue sites. In rejecting claim 22 as anticipated, the Examiner did not
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identify in Morrell any device having the required configuration, being used
in a process having the other steps recited in claim 22. Indeed, to the
contrary, as noted above, the Examiner conceded that “Morrell does not
explicitly disclose the combination of delivering therapy to first and second
tissue sites simultaneously.” Final Act. 23
Accordingly, for the reasons discussed, the Examiner does not
persuade us that Morrell describes a process having all of the steps and
features recited in Appellant’s claim 22. We therefore reverse the
Examiner’s rejection of claim 22 and its dependent claims, as being
anticipated by Morrell.
OBVIOUSNESS
The Examiner’s Rejection
In rejecting claims 1–4, 6, 7, 12–16, 19–23, 25–29, 35–42, and 44–59
for obviousness over Morrell, the Examiner found that Morrell described
processes and systems having nearly all of the claimed features, including
selecting major depression as a first symptom and bipolar disorder as a
second symptom, and selecting the anterior cingulate as the brain tissue site
corresponding to the first symptom (major depression), and the cingulate
gyrus as a distinct therapy target site corresponding to the second symptom
(bipolar disorder). Final Act. 22.
The Examiner conceded that Morrell differed from the claims in that
“Morrell does not explicitly disclose the combination of delivering therapy
to first and second tissue sites simultaneously.” Final Act. 23.
The Examiner found, however, that “Morrell discloses delivering
therapy to each of the first and second sites. Combining therapy delivery to
first and second sites simultaneously would simply involve implementing
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both therapies on the same patient, with each therapy predictably performing
the same function as it does separately.” Id.
The Examiner reasoned further:
[T]here is no evidence that delivering therapy to first and
second tissue sites simultaneously yields any critical or
different results than delivering therapy sequentially.
Therefore, it would have been obvious to one with ordinary
skill in the art at the time the invention was made to modify
Morrell to include delivering therapy to first and second tissue
sites simultaneously, since all the claimed elements were
known in the prior art and one skilled in the art could have
combined the elements as claimed by known methods with no
change in their respective functions, and the combination would
yield nothing more than predictable results to one of ordinary
skill in the art. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,
415-421, 82 USPQ2d 1385, 1395-97 (2007) and MPEP
2143(I)(A).
Id. at 23–24.
Analysis
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, although the Supreme
Court emphasized “an expansive and flexible approach” to the obviousness
analysis, id. at 415, it also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
Thus, as the Federal Circuit has since explained, “obviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d
1064, 1073 (Fed. Cir. 2015)
We agree with Appellant that a preponderance of the evidence does
not support the Examiner’s conclusion of obviousness. In particular, we are
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not persuaded that the Examiner has explained adequately why Morrell
would have motivated a skilled artisan to deliver psychiatric therapy,
substantially simultaneously, to two distinct target tissue sites.
We acknowledge the teachings in Morrell that the anterior cingulate
cortex and cingulate gyrus, which are undisputedly distinct target tissue
sites, are associated with major depression and bipolar disorder,
respectively. See Morrell ¶ 94 (“Functional and structural brain
neuroimaging in persons with major depressive disorder reveal
abnormalities in the anterior cingulate cortex.”); id. ¶ 98 (“Bipolar disorder
is associated with disturbances in attention, cognition and impulse regulation
thought to be related to disturbances in the cingulate gyrus.”).
We acknowledge Morrell’s teaching that, when treating major
depressive disorder, excitatory or inhibitory therapy may be delivered to
target sites within the brain. See id. ¶ 96.
We acknowledge Morrell’s teaching that, when treating bipolar
disorder, excitatory or inhibitory therapy may be delivered to target sites
within the brain, similar to major depressive disorder. See id. ¶¶ 99–100.
The Examiner, however, has not identified any specific teaching in
Morrell suggesting that a patient with major depressive disorder would also
have bipolar disorder, such that a skilled artisan would have been motivated
to treat both of those disorders at the same time, by simultaneously
delivering therapy to both of the brain tissues associated with those
disorders, the anterior cingulate and the cingulate gyrus. Nor has the
Examiner supplied any other rationale as to why a skilled artisan would have
stimulated the anterior cingulate and the cingulate gyrus simultaneously.
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The fact that Appellant’s disclosure might not assert criticality for
simultaneous therapy delivery to two distinct tissue sites (see Final Act. 23)
does not negate the fact Appellant’s claims all require either simultaneous
delivery to two distinct tissue sites, or a device configured to perform that
delivery. In order to establish prima facie obviousness, therefore, the
Examiner must advance a specific evidence-based explanation as to why a
skilled artisan would have performed simultaneous therapy delivery to two
distinct tissue sites. The fact that Appellant’s disclosure might not assert any
criticality to simultaneous delivery is not an adequate substitute for a
specific evidence-based explanation as to why a skilled artisan would have
performed simultaneous therapy delivery to two distinct tissue site, in the
manner recited in the claims.
At best, the Examiner has shown that a skilled artisan could have
performed the simultaneous delivery recited in Appellant’s claims. As noted
above, however, that showing is not sufficient to establish a prima facie case
of obviousness. See Belden Inc. v. Berk-Tek LLC, 805 F.3d at 1073
(“[O]bviousness concerns whether a skilled artisan not only could have
made but would have been motivated to make the combinations or
modifications of prior art to arrive at the claimed invention.”).
Accordingly, for the reasons discussed, we are not persuaded that the
Examiner has shown by a preponderance of the evidence that the subject
matter recited in claims 1–4, 6, 7, 12–16, 19–23, 25–29, 35–42, and 44–59
would have been obvious in view of Morrell. We therefore reverse the
Examiner’s rejection of those claims over Morrell.
In rejecting claims 5 and 18, which both depend ultimately from claim
1, the Examiner cited Morrell in combination with additional references to
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show the obviousness of further features recited those dependent claims.
See Final Act. 32–33. Because the additional references cited by the
Examiner fail to remedy the deficiencies discussed above of Morrell in
relation to claim 1, we also reverse the Examiner’s obviousness rejections of
claims 5 and 18.
CONCLUSION
In summary:
Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
42, 52, 53, 57, 58 112, second
paragraph
indefiniteness 42 52, 53, 57, 58
52, 57 112, fourth
paragraph
failure to further
limit
52, 57
1–7, 12–16, 18–
23, 25–29, 35–
42, 44–59
101 ineligibility for
patenting
1–7, 12–16, 18–
23, 25–29, 35–
42, 44–59
22, 23, 25 102(b) Morrell 22, 23, 25
1–4, 6, 7, 12–16,
19–23, 25–29,
35–42, 44–59
103(a) Morrell 1–4, 6, 7, 12–16,
19–23, 25–29,
35–42, 44–59
5 103(a) Morrell, Hamilton 5
18 103(a) Morrell, Tadlock 18
Overall
Outcome
42, 52, 57 1–7, 12–16, 18–
23, 25–29, 35–
41, 44–51, 53–
55, 58, 59

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