Joseph P. Giuffrida et al.

Patent Trials and Appeals Board

May 27, 2020

13785273 - (D) (P.T.A.B. May. 27, 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.
13/785,273 03/05/2013 Joseph P. Giuffrida GLN-013 8834
14783 7590 05/27/2020
Great Lakes NeuroTechnologies Inc.
4415 Euclid Ave. Ste. 500
Cleveland, OH 44103
EXAMINER
FERNANDES, PATRICK M
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
05/27/2020 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JOSEPH P. GIUFFRIDA and DUSTIN A. HELDMAN
____________________

Appeal 2018-007783
Application 13/785,273
Technology Center 3700
____________________

Before JOSEPH A. FISCHETTI, ROBERT L. KINDER, and
CARL L. SILVERMAN, Administrative Patent Judges.

SILVERMAN, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 seeks our review under 35 U.S.C. § 134(a) of the
Examiner’s final rejection of claims 1–14 and 21–26, which constitute all
pending claims. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant’s invention relates to quantification of severity of a
subject’s movement disorder. Abstract; Spec. 1:11–14, 51–15–25; Fig. 8.

1 Throughout this Decision, we use the word “Appellant” to refer to
“applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies Great
Lakes NeuroTechnologies Incorporated as the real party in interest. Appeal
Br. 2.
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Claims 1 and 8 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal (emphases
added):
1. A method of quantifying severity of a subject’s movement
disorder comprising the steps of:
providing a device to a subject, the device comprising at
least one sensor having a signal corresponding to a subject’s
external body motion associated with a non-postural symptom of
a movement disorder, and the device adapted to be worn, held or
attached to the subject;
measuring the subject’s external body motion with the at
least one sensor while the subject performs at least one
movement disorder test corresponding to at least one movement
disorder symptom;
transmitting a signal from the at least one sensor to a
processor comprising a symptom severity quantification
algorithm;
calculating substantially in real time with the processor
and symptom severity quantification algorithm a symptom
severity quantification score based at least in part on the signal
from the at least one sensor; and
outputting the symptom severity quantification score or
data related to the symptom severity quantification score to treat
the subject or notify the subject or a clinician of the current
severity of the symptom;
wherein the method exhibits a real-time-average intraclass
correlation (ICC) of at least 0.80 corresponding to the calculated
symptom severity quantification score for repeated iterations of
the method while the subject performs the same test.

Appeal Br. 82 (Claims App’x).

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REFERENCES
Name Reference Date
Salarian et al. US 2011/0092860 A1 Apr. 21, 2011
DeVaul et al. US 2006/0282021 A1 Dec. 14, 2006
Avinash et al. US 2009/0292478 A1 Nov. 26, 2009
Jeansonne et al. US 2007/0162238 A1 July 12, 2007
Cowings US 5,694,939 Dec. 9, 1997
Chang et al. US 2013/0015976 A1 Jan.17, 2013
McNeil et al. US 2007/0032748 A1 Feb. 8, 2007
Scott US 2012/0046907 A1 Feb. 23, 2012
Huang et al. Minimal Detectable
Change of the Timed
“Up & Go” Test and
the Dynamic Gait
Index in People With
Parkinson Disease,
Physical Therapy
91:114–121
Oct. 14, 2010

REJECTIONS
Claims 1–14 and 21–26 are rejected under 35 U.S.C. § 101 as being
directed to patent-ineligible subject matter. Final Act. 5–7.
Claims 1 and 8 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C.
§ 112 (pre-AIA), first paragraph, as failing to comply with the written
description requirement. Final Act. 7–8.
Claims 1 and 8 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C.
§ 112 (pre-AIA), first paragraph, as failing to comply with the enablement
requirement. Final Act. 8–10.
Claims 1, 8, 22, 23, 25, and 26 are rejected under 35 U.S.C. § 112(b)
or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite for
failing to particularly point out and distinctly claim the subject matter which
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the inventor or a joint inventor, or for pre-AIA the applicant regards as the
invention. Final Act. 10–11.
Claims 1–3 and 21–23 are rejected under pre-AIA 35 U.S.C. § 103(a)
as being unpatentable over Salarian, DeVaul, Cowings, and Avinash. Final
Act. 11–13.
Claim 4 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Cowings, Avinash, Scott, and
Jeansonne. Final Act. 13–14.
Claim 5 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Cowings, Avinash, Scott, and Chang.
Final Act. 14.
Claim 6 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Cowings, Avinash, and Chang. Final
Act. 14–15.
Claim 7 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Cowings, Avinash, Scott, and McNeil.
Final Act. 15.
Claim 21 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Cowings, Avinash, and Huang. Final
Act. 15.
Claims 8–10 and 24–26 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Salarian, DeVaul, Huang, and Avinash.
Final Act. 15–18.
Claim 11 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Huang, Avinash, Scott, and Jeansonne.
Final Act. 18.
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Claims 12 and 13 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Salarian, DeVaul, Huang, Avinash, and Chang.
Final Act. 18–19.
Claim 14 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Salarian, DeVaul, Huang, Avinash, Scott, and McNeil.
Final Act. 19.

ANALYSIS
The § 112 rejections
§ 112(b) written description rejections
In the rejection of claims 1 and 8, the Examiner finds it is unclear how
the ICC (intraclass correlation) or MDC (minimal detectable change) values
are meant to correspond to the calculated symptom qualification
measurement because it is unclear how these values are obtained. Final Act.
7–8 (citing Spec. ¶¶ 106–109). The Examiner finds it is unclear what the
“symptom severity quantification algorithm” entails. Id. at 8.
In the Appeal Brief, Appellant argues the claimed ICC and MDC
values are an unexpected result from conducting the method with the
claimed elements in the configurations claimed and described in the
Specification. Appeal Br. 10–12.
In the Answer, the Examiner finds the Specification provides no
details for the “algorithm” or how the sensors or processor are more than
generic sensors/processors that would enable these values for ICC/MDC.
Ans. 20. The Examiner finds “Applicant is merely implying that the
claimed method would have a high degree of repeatability but Applicant’s
specification never shows exactly how or what is involved within either the
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claimed method or the movement disorder tests that achieve these values.”
Id. To the contrary, the Examiner finds the generic sensors and generic
processor do not provide the ability to achieve the claimed ICC and MDC
values. Id. at 20–23 (citing Spec.2 ¶¶ 79, 80, 106–109, 112).
In the Reply Brief, Appellant reiterates arguments and argues that “the
claimed values are an unexpected result from conducting the method with
the claimed elements in the configurations claimed and described in the
Specification.” Reply Br. 8.
A written “description must ‘clearly allow persons of ordinary skill in
the art to recognize that [the inventor] invented what is claimed.’” Ariad
Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc) (alteration in original) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d
1555, 1563 (Fed. Cir. 1991)). “In other words, the test for sufficiency is
whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.” Id. (citing Vas-Cath, 935 F.2d at
1563). “Although [the applicant] does not have to describe exactly the
subject matter claimed, . . . the description must clearly allow persons of
ordinary skill in the art to recognize that [he or she] invented what is
claimed.” Vas-Cath, 935 F.2d at 1563 (alteration in original) (quoting In re
Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)). Put another way, “the
applicant must . . . convey with reasonable clarity to those skilled in the art

2 The Specification of record does not include paragraph numbers.
However, discussion of generic sensors and processor are set forth at least in
Spec. 32:19–25 (Texas Instruments MSP430-169), 28:11–27 (Analog
Devices ADXRS300).
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that, as of the filing date sought, he or she was in possession of the
invention.” Id. at 1563–64.
We agree with the Examiner’s findings regarding the claimed ICC and
MDC values. Additionally, on the record before us, there is no evidence to
support Appellant’s assertion of unexpected results. Regarding “symptom
severity quantification algorithm,” although the Specification describes
mathematical techniques, there is no recitation of the term “symptom
severity quantification algorithm,” or explanation sufficient to convey to one
skilled in the art that the inventor had possession of the claimed subject
matter.
In view of the above, we sustain the written description rejection of
claims 1 and 8.
§ 112(b) enablement rejection
In the enablement rejection of claims 1 and 8, similar to the written
description rejection, supra, the Examiner finds the Specification provides
no details for the “algorithm” or how the sensors or processor are more than
generic sensors/processors that would enable the ICC or MDC values to
enable one skilled in the art to which it pertains, or with which it is most
nearly connected, to make and/or use the invention. Final Act. 8–9. The
Examiner similarly rejects “symptom severity quantification algorithm” as
the Specification does not describe the algorithm beyond just generically
stating that an algorithm is used. Id. at 9.
In the Appeal Brief, Appellant reiterates arguments and argues “the
claims are sufficiently enabled by the disclosure, and a person having
ordinary skill in the art would readily understand that the claimed device(s)
are sensitive and accurate to a degree sufficient to produce highly repeatable
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and reliable symptom severity quantification scores for repeated iterations of
the same movement disorder test(s).” Appeal Br. 14.
In the Answer and Reply, arguments are reiterated.
The test for compliance with the enablement requirement is whether
the disclosure, as filed, is sufficiently complete to enable one of ordinary
skill in the art to make and use the claimed invention without undue
experimentation. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); In re
Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Based on the record before
us, we agree with the Examiner that the disclosure, as filed, is not
sufficiently complete to enable one of ordinary skill in the art to make and
use the claimed invention.
Therefore, we sustain the rejection of claims 1 and 8.
§ 112(b) indefiniteness rejections
Regarding claims 1 and 8, similar to the written description and
enablement rejections, supra, the Examiner finds it is unclear how the ICC
or MDC values are meant to correspond to the calculated symptom
quantification measurement. Final Act. 10.
Regarding claims 1, 8, 22, 23, 25, and 26, the Examiner finds the
limitation “for repeated iterations of the method while the subject performs
the same test” is unclear exactly what the term “test” is referring to. Final
Act. 10–11. In particular, the Examiner questions: “Is the test supposed to
refer to the ‘movement disorder test? Or is it supposed to refer to the
claimed method overall? Further the claim states ‘at least one movement
disorder test’ thus the limitation ‘the same test’ is even more unclear as it’s
not clear what test it would refer to in the situation more than one test are
used.” Id.
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Regarding claims 1 and 8, which respectively recite “the method
exhibits a real-time average intraclass correlation (ICC)” and “the method
exhibits a real-time average minimal detectable change (MDC),” the
Examiner finds it is unclear what is meant by the method exhibiting a real-
time average statistical variable as it is not clear how the real-time average
aspect is meant to be incorporated with either the method or the statistical
variable. Id. at 11.
Appellant argues “the same test” refers to “repeated iterations of any
individual test that is employed.” Appeal Br. 12–13. Appellant argues the
“symptom severity quantification algorithm” is described sufficiently in the
Specification. Id. at 13 (citing Spec. Figs. 8–11; 60:8–61:7).
Appellant argues the claim states that the ICC or MDC values
correspond to the calculated symptom severity quantification score — which
is produced by performance of the method during the at least one movement
disorder test, and a person having ordinary skill in the art would understand
that ICC and MDC are measures of repeatability. Id. at 15. Appellant
argues that the claim language is clear in that iterations of the method
involve repetitions of the same movement disorder test and, in the event that
more than one movement disorder test is used, each of the movement
disorder tests would be repeated. Id. at 16–17.
Appellant argues the term “real time” is described in the Specification
and correlates the calculation of the claimed statistical variables to a real-
time constraint in regards to performance of the method as a means to
identifying the accuracy and repeatability of the method using the claimed
steps and elements. Id. at 17–18 (citing Spec. 45:6–46:6).
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In the Answer, the Examiner finds the term “same test” is a singular
term and thus does not apply should there be more than one test of the
movement disorder tests being performed. Ans. 23. According to the
Examiner, “same test” is not a plural term and thus in no way corresponds to
or is inherently tied to multiple tests. Id. Regarding the real-time average,
the Examiner finds it is unclear because
[p]er the section of Applicant’s specification cited by the
applicant the real-time is with respect to tests being repeated but
it is unclear again exactly what it is referring to within the context
of the claim. Is it meant to refer to the entire methods as a whole
or towards singular movement disorder tests, or is it meant
towards the specific calculation of the severity score?
Applicant’s cited section refers to the term ‘test’ but is that
referring to a movement disorder test or the method as a whole?
Thus it is still unclear.
Id. at 23–24.
In the Reply Brief, Appellant argues iterations of the method involve
repetition of the same movement disorder test and methods and tests are
distinct recitations where the method is the overall set of claimed tests and
test is the at least one movement disorder test. Reply Br. 10. Appellant
presents a similar argument regarding “whether the description of real time
operation is applicable to the method (again being the claimed method) or
the test (again being the claimed movement disorder test(s)).” Id. at 11.
We are not persuaded by the Examiner’s findings regarding
indefiniteness based on the understanding of one of ordinary skill in the
art. “[A] claim is indefinite when it contains words or phrases whose
meaning is unclear.” In re Packard, 751 F.3d 1307, 1310 (Fed. Cir. 2014).
To the contrary, we find the claim language “ICC or MDC values,” and their
correspondence to the calculated score, the same test, and real-time are
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sufficiently clear and would delineate the scope of the invention to a person
of ordinary skill in the art with reasonable certainty. Although the claim is
broad in scope, on the record before us, the scope of these terms are
sufficiently clear to one of ordinary skill in the art. “Breadth is not
indefiniteness.” In re Gardner, 427 F.2d 786, 788 (CCPA 1970). We are
persuaded by Appellant’s arguments regarding the “same test” as the context
of the claim and the Specification support the same test is repeating the
individual test that is employed.
In view of the above, we do not sustain the indefiniteness rejection of
claims 1, 8, 22, 23, 25 and 26.

The § 101 rejection
PRINCIPLES OF LAW
Patent-eligible subject matter is defined in 35 U.S.C. § 101 of the
Patent Act, which recites:
Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefor, subject
to the conditions and requirements of this title.
There are, however, three judicially created exceptions to the broad
categories of patent-eligible subject matter in 35 U.S.C. § 101: “[l]aws of
nature, natural phenomena, and abstract ideas.” Alice Corp. Pty. Ltd. v. CLS
Bank Int’l, 573 U.S. 208, 216 (2014) (quotation marks and citation omitted);
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70
(2012) (brackets in original).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court’s two-step framework, described in Mayo
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and Alice. See 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 id. at 219 (“On their face, the claims before us
are drawn to the concept of intermediated settlement, i.e., the use of a third
party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593,
611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic
concept of hedging, or protecting against risk.”).
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611);
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and
mental processes (Gottschalk v. Benson, 409 U.S. 63, 69 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191
(1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that “[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We
view respondents’ claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula.”). Having
said that, the Supreme Court also indicated that a claim “seeking patent
protection for that formula in the abstract . . . is not accorded the protection
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of our patent laws, . . . and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment.” Id. (citing Benson and Flook); see, e.g., id. at 187 (“It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.”).
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 (citation omitted). “A claim
that recites an abstract idea must include ‘additional features’ to ensure ‘that
the [claim] is more than a drafting effort designed to monopolize the
[abstract idea].’” Id. (quoting Mayo, 566 U.S. at 77 (alteration in original)).
“[M]erely requir[ing] generic computer implementation[] fail[s] to transform
that abstract idea into a patent-eligible invention.” Id.
The United States Patent and Trademark Office (“USPTO”) recently
published revised guidance on the application of § 101. USPTO, 2019
Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7,
2019) (“Guidance”). “All USPTO personnel are, as a matter of internal
agency management, expected to follow the guidance.” Id. at 51; see also
October 2019 Update at 1 (October 2019 Update: Subject Matter
Eligibility).
Under that guidance, we first determine whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
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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)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
See Guidance, 84 Fed. Reg. at 52–56.
A claim that integrates a judicial exception into a practical application
applies, relies on, or uses the judicial exception in a manner that imposes a
meaningful limit on the judicial exception, such that the claim is more than a
drafting effort designed to monopolize the judicial exception. See Guidance,
84 Fed. Reg. at 54. When the judicial exception is so integrated, then the
claim is not directed to a judicial exception and is patent eligible under
§ 101. Id.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
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See Guidance, 84 Fed. Reg. at 54–56.
Turning to Step 2B of the Guidance, “[t]he second step of the Alice
test is satisfied when the claim limitations ‘involve more than performance
of []well-understood, routine, [and] conventional activities previously
known to the industry.’” Berkheimer v. HP Inc., 881 F.3d 1360, 1367 (Fed.
Cir. 2018) (quoting Content Extraction & Transmission LLC v. Wells
Fargo Bank, Nat’l Ass’n, 776 F.3d 1343, 1347–48 (Fed. Cir. 2014), and
Alice, 573 U.S. at 225). “Whether something is well-understood, routine,
and conventional to a skilled artisan at the time of the patent is a factual
determination.” Berkheimer, 881 F.3d at 1369.
The USPTO has issued guidance regarding the required information
to support “routine and conventional” factual determinations. See
Berkheimer, 881 F.3d at 1369. In particular, the Memorandum of Changes
in Examination Procedure Pertaining to Subject Matter Eligibility, Recent
Subject Matter Eligibility Decision (Berkheimer v. HP, Inc.) (“Berkheimer
Memorandum”) requires the information listed below:
1. A citation to an express statement in the specification or to a
statement made by an applicant during prosecution that
demonstrates the well-understood, routine, conventional
nature of the additional element(s). . . .
2. A citation to one or more of the court decisions discussed in
MPEP § 2106.05(d)(II) as noting the well-understood,
routine, conventional nature of the additional element(s).
3. A citation to a publication that demonstrates the well-
understood, routine, conventional nature of the additional
element(s). . . .
4. A statement that the examiner is taking official notice of the
well-understood, routine, conventional nature of the
additional element(s). . . .

Berkheimer Memorandum at 3–4.
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The § 101 Rejection of claims 1−14 and 21−26
The Examiner determined that claims 1–14 and 21–26 are directed to
abstract ideas of receiving data such as data related to a user’s body motion,
transmitting that data, calculating a measure based on that data, and
outputting that data. Final Act. 5–6. According to the Examiner, much of
the claim limitations are directed to the abstract ideas of:
i. “Comparing information regarding a sample or test
subject to a control or target data” (Ambry/Myriad CAFC);
ii. “Data recognition and storage” (Content Extraction);
iii. “Collecting and comparing known information”
(Classen);
iv. “Collecting information, analyzing it, and displaying
certain results of the collection and analysis” (Electric Power
Group);
v. “Comparing new and stored information and using rules
to identify options” (Smartgene);
vi. “Storing, gathering, and analyzing data” (TOE
Petroleum);
vii. “Using categories to organize, store, and transmit
information” (Cyberfone);
viii. “Mental process that a neurologist should follow
when testing a patient for nervous system malfunctions”
(Meyer).
ix. “Collecting, displaying, and manipulating data” (Int.
Ventures v. Cap One Financial)
x. “Obtaining and comparing intangible data”
(CyberSource)
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xi. “Organizing and manipulating information through
mathematical correlations” (Digitech)
xii. “An algorithm for calculating parameters indicating an
abnormal condition” (Grams)
Id. at 6.
The Examiner then determines:
The additional elements recited in the claims are the
processor, the sensor, and the device having a real-time average
intraclass correlation (ICC) of at least .80 or MDC of 15% or
less. These additional elements do not provide significantly more
because they can be implemented by a generic
computer/processor and generic sensors. Neither individually
nor as a combination do the additional elements provide more
functionality than that of a generic computer/processor and
generic sensors. Further, there are no additional elements or
limitations that improve the functioning of a computer itself,
applies the abstract idea with a particular machine (in this case,
the method can be performed by a generic computer performing
generic computer functions), or adds meaningful limitations that
amount to more than generally linking the use of the abstract idea
to a particular technological environment. Furthermore the
device used in the method having an intraclass correlation of at
least 0.80 or MDC of 15% or less does not improve the process
itself. The dependent claims pertain to the above listed abstract
ideas and in combination do not provided significantly more.
Applicant’s specification provides no details for the
‘algorithm’ or how the sensors or processor are more than
generic sensors/processors that would enable these values for
ICC/MDC. Applicant is merely implying that the claimed
method would have a high degree of repeatability but
Applicant’s specification never shows exactly how or what is
involved within either the claimed method or the movement
disorder tests that achieve these values. One of ordinary skill in
the art would not be able to achieve these values without any
details exactly showing what provides these values. Applicant’s
disclosure states how to control the known in the art movement
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disorder tests to achieve better ICC and MDC values but
Applicant’s claims have the ICC and MDC values directed to the
claim method as a whole not just the known in the art movement
disorder tests. There is no disclosure concerning how exactly the
claimed method is made to achieve the desired ICC and MDC
values.

Id. at 6–7
In the Appeal Brief, Appellant argues the Examiner oversimplifies
and misinterprets the claim limitations, and “[t]he fact that it is the severity
being quantified, in the form of a symptom severity quantification score
alone is enough to establish that the system transforms the data in a manner
that extends beyond any of the listed abstract ideas.” Appeal Br. 5.
Appellant argues the claimed invention is “inextricably tied to physical
machines and distinct from the types of concepts found by the courts to be
abstract” and “does not preempt an entire field of endeavor.” Id. at 8.
Appellant argues, “like in DDR Holdings, the claimed solution in the present
invention is necessarily rooted in the technology in order to overcome a
problem specifically arising in the realm of this specific monitoring/therapy.
Id. at 9 (citing DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed.
Cir. 2014)).
Appellant argues the Examiner failed to recognize the transformation
of the data taking place because the claims do not merely collect, recognize
and store data, the claims take measured movement data and transform that
data using a processor into a system severity quantification score and this
quantification score is readily ascertainable to be much more than merely
recognized, stored and/or organized data obtained from the sensors. Id.
According to Appellant, “[a] person having ordinary skill in the art would
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readily understand that the claimed symptom quantification measure
requires far more than the judicial exceptions on which the Examiner relied,
and instead is a complex process that requires transforming measured data,
with a processor, into a wholly new form – which is not a judicially
recognized exception, and is eligible subject matter.” Id. at 10.
Regarding the claimed ICC and MDC values, Appellant argues:
The Examiner further argued that the specification fails to
provide details for the algorithm or how the claimed ICC/MDC
values are achieved, and that a person having ordinary skill in the
art would be unable to achieve these values. Office action,
11/9/2017, pg. 7. The Appellants, however, point out that as
detailed below and previously, the achieved values are an
unexpected result achieved by the components and arrangement
thereof detailed in the specification. The claimed methods are
carried out by the structures claimed and described in the
specification, and as a result of the combination of elements and
steps using those elements, their invention achieved unexpected
highly accurate and repeatable results. A person having ordinary
skill in the art would be able to achieve those results given the
disclosure describing each of the elements and steps.

Id. at 10.
In the Answer, the Examiner cites additional cases and asserts
Appellant’s argument attempts to provide more meaning to the claim
language than what readily appears in the claim. Ans. 17–20. Regarding the
additional elements, the Examiner finds:
The additional elements that have been identified are the
sensors, the processor, and the ICC/MDC values. There are no
significance provided by these additional elements. They can be
merely a generic processor and generic sensors such as
gyroscopes and accelerometers that are known in the art.
Applicant has not provided any specialized sensors or processors
that improve their known generic counterparts. Further as per the
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claimed ICC/MDC values there is no stated impact on the
method or how they improve the method. As shown in the
applied art ICC/MDC are just known statistical measures which
are things one of ordinary skill in the art would want to optimize.
Further as shown in the applied art devices with these values are
generic to the art. Neither alone nor in combination do the
additional elements provide significantly more because they are
again just merely a generic processor and generic sensors, all of
which are known in the art. Applicant’s method is merely
gathering data (the signal) and converting that data into another
mathematical representation or grouping (the symptom
quantification measure) applied with generic sensors and a
generic processor.
Examiner notes Paragraph 0079 of Applicant’s published
specification which details the use of multiple commercially
available sensors such as gyroscopes (ADXRS300) and
accelerometer, from Analog Devices (ADXL210). Examiner
notes these commercially available sensors would be commonly
known and thus are considered generic. Further Applicant states
using electrodes and sensors that one of ordinary skill in the art
would know of (See Paragraphs 0079-0080 of Applicant’s
published specification). Examiner even further notes Applicant
states the use of a commercial processor (Texas Instruments
mSP430-169) in Paragraph 0076 of Applicant’s published
specification.

Id. at 17–18.
The Examiner finds, when viewing the claims as a whole, there are no
additional elements or limitations that improve the functioning of a
computer itself, applies the abstract idea with a particular machine other than
a generic computer performing generic computer function, or adds
meaningful limitations that amount to more than generally linking the use of
the abstract idea to a particular technological environment. Id. at 19–20.
The Examiner determines that the additional elements are claimed with a
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high level of generality. Id. at 20. The Examiner asserts that the claims are
analogous to claims found ineligible in Electric Power. Id. at 19 (citing
Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016)).
In the Reply Brief, Appellant reiterates and argues the claims are
much more than the generic handling of data argued by the Examiner.
Reply Br. 2–5. Appellant argues the claimed ICC values are not taught by
the references, for the subject matter claimed, and these values are “an
unexpected result.” Id. at 8. Additionally, Appellant argues for the first
time3 that the Examiner’s analysis is not in compliance with Berkheimer and
the Berkheimer Memorandum. Id. at 5–7. In particular, Appellant argues:
With respect to the instant application, the Appellants note
that although the Examiner pointed to the exemplary
commercially available sensors disclosed in the Specification
and several cases from MPEP § 2106.05(d)(II), the fact is that
the claimed elements are sufficiently distinguishable from the
Examiner’s cited sources so as to render the analysis incorrect.
The Appellants have argued and differentiated the relevant facts
from the cited cases, and demonstrated how the claimed
inventions involve, at the very least, processing and
transformation of data that is not merely one of the abstract ideas
presented in the cases, but actually requires significantly more.
In short, the Appellants respectfully submit that the Examiner’s
factual analysis in comparing the claimed invention to the case
law under MPEP § 2106.0S(d)(II) involved unreasonable parsing
out of individual elements of the claims that, in a vacuum, might
be distilled and simplified into ineligible subject matter, but
ignored the claims as a whole which include processing and
transformation of data that are not only not disclosed in the prior
art, but clearly are not well-understood, routine, conventional.

3 The Berkheimer decision was issued February 18, 2018, the Appeal Brief
was filed February 28, 2018, the Berkheimer Memorandum was issued April
19, 2018, the Answer was issued May 25, 2018, and the Reply Brief was
filed July 19, 2018.
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This is specifically and most readily apparent with respect
to the claimed ICC and MDC values. Not only are such values
not disclosed in any citations of case law or prior art, but there is
nothing on the record at all to even suggest that such values are
known at all, let alone well-understood, routine, conventional, as
claimed. The Appellants respectfully point out the relevant claim
limitations read, for example, “wherein the method exhibits a
real-time average intraclass correlation (ICC) of at least 0.80
corresponding to the calculated symptom severity quantification
score for repeated iterations of the method while the subject
performs the same test,” and “wherein the method exhibits a real-
time average minimal detectable change (MDC) that represents
a change of about 15% or less of the total scale of the particular
test corresponding to the calculated symptom severity
quantification score for repeated iterations of the method while
the subject performs the same test .” Although ICC and MDC are
known statistical calculations, there is nothing to show that the
specifically claimed values are known for the explicitly defined
method and output. Clearly, at the very least, these claimed
values are not well-understood, routine, conventional given the
specific elements and steps required to achieve those values for
the claimed calculated symptom severity quantification sore.
Much like claims 4-7 of the Berkheimer case, the claims here
include limitations directed to purported improvement described
in the specification, which at the very least raises the question of
fact as to whether these improvements are well-understood,
routine, conventional, and which the Appellants maintain the
Examiner concluded based on incorrect interpretations and
conclusions. Thus, given that the Examiner’s analysis was based
on an unreasonable parsing of the elements, the Appellants
respectfully submit that the factual determinations are incorrect,
and that therefore the Examiner’s conclusion is also incorrect and
the claimed element(s) are, in fact, not well-understood, routine,
conventional.

Id. at 6–7.
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Below, pursuant to the Guidelines, claim 1 is reviewed with regard to
reciting the abstract ideas of mental processes and organizing human
activity. The claim 1 limitations may be parsed as set forth below wherein
elements that reflect recitation of these abstract ideas are italicized:
1. A method of quantifying severity of a subject's movement
disorder comprising the steps of:
providing a device to a subject, the device comprising at
least one sensor having a signal corresponding to a subject's
external body motion associated with a non-postural symptom of
a movement disorder, and the device adapted to be worn, held or
attached to the subject;
measuring the subject's external body motion with the at
least one sensor while the subject performs at least one movement
disorder test corresponding to at least one movement disorder
symptom;
transmitting a signal from the at least one sensor to a
processor comprising a symptom severity quantification
algorithm;
calculating substantially in real time with the processor
and symptom severity quantification algorithm a symptom
severity quantification score based at least in part on the signal
from the at least one sensor; and
outputting the symptom severity quantification score or
data related to the symptom severity quantification score to treat
the subject or notify the subject or a clinician of the current
severity of the symptom;
wherein the method exhibits a real-time-average intraclass
correlation (ICC) of at least 0.80 corresponding to the calculated
symptom severity quantification score for repeated iterations of
the method while the subject performs the same test.

In addition to the Examiner’s finding that much of the claim
limitations are directed to the abstract idea of “receiving data such as data
related to a user’s body motion, transmitting that data, calculating a measure
based on that data, and outputting that data” (Final Act. 6), each of the
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italicized limitations can be performed as mental processes. If a method can
be performed by human thought alone, or by a human using pen and paper,
it is merely an abstract idea and is not patent eligible under § 101.
CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372–73 (Fed.
Cir. 2011). “That purely mental processes can be unpatentable, even when
performed by a computer, was precisely the holding of the Supreme Court in
Gottschalk v. Benson.” Id. at 1375. See also Synopsys, Inc. v. Mentor
Graphics Corp., 839 F.3d 1138, 1146–47 (Fed. Cir. 2016).
Here, the claim is broadly written and recites quantifying a severity of
movement disorder of a subject. In particular, the italicized recitations can
be done by an observer of the subject and can be accomplished mentally and
by pen and paper. Additionally, the term “real-time” is used in the
Specification to broadly include 30 minutes to substantially simultaneously.
Spec. 41:2–42:3.
In view of the above, we determine that claim 1 recites the abstract
idea of mental processes, and is analogous to Electric Power Group
(concluding “a process of gathering and analyzing information of a specified
content, then displaying the results, and not any particular assertedly
inventive technology for performing those functions” as directed to an
abstract idea). Additionally, we note that the italicized limitations also recite
the abstract idea of organizing human activity, such as “managing personal
behavior or relationships or interactions between people,” such as “social
activities, teaching, and following rules or instructions.” See Guidance, 84
Fed. Reg. at 52.
The Federal Circuit explains the “directed to” inquiry is not simply
asking whether the claims involve a patent-ineligible concept:
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The “directed to” inquiry . . . cannot simply ask whether the
claims involve a patent-ineligible concept, because essentially
every routinely patent-eligible claim involving physical products
and actions involves a law of nature and/or natural
phenomenon—after all, they take place in the physical world.
See Mayo, 132 S.Ct. at 1293 (“For all inventions at some level
embody, use, reflect, rest upon, or apply laws of nature, natural
phenomena, or abstract ideas.”). Rather, the “directed to”
inquiry applies a stage-one filter to claims, considered in light of
the specification, based on whether “their character as a whole is
directed to excluded subject matter.”
Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016); see
also Diehr, 450 U.S. at 188 (“In determining the eligibility of respondents’
claimed process for patent protection under § 101, their claims must be
considered as a whole.”); McRO, Inc. v. Bandai Namco Games Am. Inc., 837
F.3d 1299, 1314 (Fed. Cir. 2016) (the question is whether the claims as a
whole “focus on a specific means or method that improves the relevant
technology or are instead directed to a result or effect that itself is the
abstract idea and merely invoke generic processes and machinery”).
Therefore, we proceed to Step 2A, Prong 2, of the Guidance to
determine whether additional elements recited in the claims beyond the
judicial exception of claim 1 integrate the abstract idea into a practical
application. Such additional elements may reflect an improvement to a
technology or technical field. See Guidance, 84 Fed. Reg. at 55.
As discussed below, there are no additional limitations recited beyond
the judicial exception itself that integrate the exception into a practical
application. More particularly, the claims do not recite: (i) an improvement
to the functionality of a computer or other technology or technical field (see
MPEP § 2106.05(a)); (ii) a “particular machine” to apply or use the judicial
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exception (see MPEP § 2106.05(b)); (iii) a particular transformation of an
article to a different thing or state (see MPEP § 2106.05(c)); or (iv) any other
meaningful limitation (see MPEP § 2106.05(e)). See also Guidance, 84 Fed.
Reg. at 55.
We determine the additional elements of claim 1 do not integrate the
abstract idea into a practical application. We refer to the additional
elements: a device, at least one sensor, and a processor.
These additional elements merely perform, or apply the abstract idea.
The claim is broadly written and the improvement, if any, of the claim is in
the abstract idea itself, not in the functionality of a computer or other
technology or technical field. No particular machine, no transformation, no
other meaningful limitation is persuasively argued by Appellant.
Additionally, the additional elements do not use the alleged abstract idea in a
meaningful way beyond generally linking the use of the judicial exception to
a particular technological environment, such that the claim as a whole is
more than a drafting effort designed to monopolize the exception. See
MPEP § 2106.05(e).
The additional elements merely implement an abstract idea using
known body worn sensors and a processor as tools to perform the abstract
idea. See MPEP § 2106.05(f). The limitations add insignificant extra-
solution activity to the abstract idea. See MPEP § 2106.05(g). The
limitations merely use the abstract idea by linking it to a particular
technological environment. See MPEP § 2106.05(e).
The limitations (ICC) of “at least 0.80” of claim 1 and (MDC) of
“about 15% or less” of independent claim 8 are broadly claimed and these
values are known desirable correlation values. See, e.g., Ans. 22–23.
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Because the additional elements of claims 1 and 8 do not integrate the
abstract idea into a practical application, we determine claim 1, and
independent claim 8, which is commensurate4 in scope with claim 1, are
directed to an abstract idea. See Guidance, Step 2A, Prong 2.
Because we determine the claims are directed to an abstract idea, we
analyze the claims under step two of Alice to determine whether there are
additional limitations that individually, or as an ordered combination, ensure
the claims amount to “significantly more” than the abstract idea. Alice, 573
U.S. at 217–18 (citing Mayo, 566 U.S. at 72–73, 77–79). As stated in the
Guidance, many of the considerations to determine whether the claims
amount to “significantly more” under step two of the Alice framework are
already considered as part of determining whether the judicial exception has
been integrated into a practical application. 84 Fed. Reg. at 56. Thus, at this
point of our analysis, we determine if the claims add a specific limitation, or
combination of limitations, that is not well-understood, routine, conventional
activity in the field, or simply appends well-understood, routine,
conventional activities at a high level of generality. Id.
As with the integration into a practical application analysis discussed
above, an inventive concept “cannot be furnished by the unpatentable law of
nature (or natural phenomenon or abstract idea) itself.” Genetic Techs. Ltd.
v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016); see also Guidance,
84 Fed. Reg. at 56; Alice, 573 U.S. at 217 (explaining that, after determining
a claim is directed to a judicial exception, “we then ask, ‘[w]hat else is there
in the claims before us?’” (emphasis added, brackets in original)
(quoting Mayo, 566 U.S. at 78)). Instead, an “inventive concept” is

4 Claim 8 recites an MDC value whereas claim 1 recites an ICC value.
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furnished by an element or combination of elements that is recited in the
claim in addition to the judicial exception and sufficient to ensure the claim
as a whole amounts to significantly more than the judicial exception
itself. Alice, 573 U.S. at 218–19 (citing Mayo, 566 U.S. at 72–73); see BSG
Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018)
(explaining that the Supreme Court in Alice “only assessed whether the
claim limitations other than the invention’s use of the ineligible concept to
which it was directed were well-understood, routine and conventional,”
(emphasis added)).
On the record before us, the claims fail to recite specific limitations
(or a combination of limitations) that are not well-understood, routine, and
conventional. Rather, the additional elements (i.e., a device, the sensors,
each having a signal, and a processor) are generic sensor and computer
components recited at a high level of generality or basic computer functions,
none of which Appellant persuasively argues is beyond what was well-
understood, routine, and conventional in the art. See Spec. 22:7–14, 27:16–
30, 39:9–29; see also Mortgage Grader, Inc. v. First Choice Loan Servs.
Inc., 811 F.3d 1314, 1324–25 (Fed. Cir. 2016) (generic computer
components such as an “interface,” “network,” and “database” fail to satisfy
the inventive concept requirement).
To the extent Appellant argues the claim recites a solution to a
problem in computer technology that adds significantly more, we note that
these steps are part of the ineligible abstract idea. “If a claim’s only
‘inventive concept’ is the application of an abstract idea using conventional
and well-understood techniques, the claim has not been transformed into a
patent-eligible application of an abstract idea.” BSG Tech, 899 F.3d at
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1290–91 (citing Berkheimer, 881 F.3d at 1370). “[I]t is irrelevant whether
[the claimed abstract idea] may have been non-routine or unconventional as
a factual matter . . . narrowing or reformulating an abstract idea does not add
‘significantly more’ to it.” BSG Tech, 899 F.3d at 1291.
We are not persuaded by Appellant’s arguments raised in the Reply
Brief regarding Berkheimer and the Berkheimer Memorandum. The
Examiner’s analysis and findings are consistent with Berkheimer and the
Berkheimer Memorandum. In particular, the Examiner identifies applicable
case law and also referred to Specification statements that demonstrate the
well-understood, routine, conventional nature of the additional elements.
See, e.g., Ans. 18 (citing Spec.5 ¶¶ 75, 76 (describing commercially
available sensors and commercial processors)). Additionally, as discussed,
supra, Appellant’s arguments are not commensurate with the broadly written
claims. Moreover, as discussed supra, on the record before us, there is
insufficient evidence to support Appellant’s arguments regarding unexpected
results of the claimed invention.
Regarding case law cited by the Examiner and Appellant, we are not
persuaded by Appellant’s arguments. The claims here are unlike Enfish and
DDR as the claims before us are broadly written and do not recite an
improvement to a computer. As discussed supra, if the claims recite any
improvement, this improvement is to an abstract idea. Because the claim
does not solve a problem in the software arts, claim 1 is unlike the
technology-based integrations cited by Appellant. For example in Enfish,
the patent-eligible claim was directed to a self-referential table to improve
computer databases. 822 F.3d at 1337. Likewise, in McRO, the patent-

5 See note 2, supra.
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eligible claim focused on a specific asserted improvement in computer
animation. By contrast, the claims are, at best, an improvement to
quantifying severity of movement disorder symptoms of a subject. Abstract;
Spec. 1:11–13. Considering the claim as a whole, Appellant’s invention
lacks a technical solution to a technical problem like the claims in these
cases.
Regarding preemption, our reviewing court provides applicable
guidance: “While preemption may signal patent ineligible subject matter,
the absence of complete preemption does not demonstrate patent eligibility.”
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir.
2015); Ultramercial, Inc. v. Hulu, LLC, 722 F.3d 1335, 1346 (Fed. Cir.
2013).
For the above reasons, Appellant has not persuaded us of Examiner
error, and we sustain the Examiner’s rejection of claim 1, independent claim
8, and dependent claims 2–7, 9–14, and 21–26 as these claims are not argued
separately.

The § 103 Rejections
Claims 1–3 and 216–23 over Salarian, DeVaul, Cowings, and
Avinash
The Examiner finds the combination of Salarian and Avinash teaches
the claim 1 limitations, except “(ICC) of at least 0.80 corresponding to the
calculated symptom severity quantification score for repeated iterations of

6 Although claim 21 is identified in the heading of this rejection, it is not
addressed by the Examiner in this rejection. See Final Act. 6, 2–7. Claim 21
is separately rejected over Salarian, DeVaul, Avinash, and Huang. See Final
Act. 15, and is addressed infra.
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the method while the subject performs the same test” and “calculating
substantially in real time,” and relies on Cowings and DeVaul, respectively,
for teaching these limitations. Final Act. 11–13 (citing Salarian ¶¶ 31–34;
DeVaul ¶¶ 3, 14–18; Avinash ¶¶ 6, 7, 39, 40, 62, 81, 89, 90; Cowlings
14:21–41). The Examiner determines it would have been obvious to one of
ordinary skill in the art to have modified Salarian with Avinash because, as
Appellant states in the Background of the Invention, the use of a severity
score is known in the art and because it facilities efficient diagnosis of a
patient by a healthcare provider. Id. at 12. The Examiner concludes that
“[i]t would have been obvious to one of ordinary skill in the art to have
modified Salarian with DeVaul such that the calculation of the symptom
quantification measure occurs in real-time so that diagnosis of the patient
can occur as soon as possible before further more severe symptoms may
arise and because it benefits people who have chronic conditions that require
continuous and proactive monitoring.” Id.
The Examiner refers to Salarian’s Figure 10 teaching of calculating an
ICC, and additionally finds:
Cowings teaches the use of intraclass correlations as being a
known statistic model and that it is a standard within the
scientific field to have a value greater than or equal to 0.80
(Column 14, Lines 21-41). It would have been obvious to one of
ordinary skill in the art to have modified Salarian with Cowings
because having excellent reliability is a necessity in the medical
field to help prevent false positives and false negatives and since
it has been held that discovering an optimum value of a result
effective variable involves only routine skill in the art. In re
Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and further
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because Cowings teaches an ICC of greater than 0.80 as being a
scientific standard.

Id. at 12–13.
Appellant argues Salarian teaches metrics to objectively quantify
movement disorders but not symptom severity, and additional processing
and analysis is required to turn the raw measured metrics taught by Salarian
into a score such as that claimed, and Salarian fails to teach these additional
steps. Appeal Br. 22. According to Appellant, Avinash teaches severity
scores but does not teach a symptom severity quantification score or the use
of a symptom severity quantification algorithm. Id. at 23. Appellant argues
that “[a]lthough DeVaul is being used to supply real time processing, the
fact is that there is no indication that DeVaul’s system is capable of
performing the advanced processing and analysis required by the present
invention in real-time.” Id. at 24. Appellant argues there is insufficient
basis for the suggested combination of references and the Examiner has not
established the level of skill in the art. Appeal Br. 21–33.
In the Answer, the Examiner finds Appellant’s arguments are directed
to the references individually but the rejections are based on the combination
of the references. Ans. 24–25. The Examiner notes that “the features upon
which applicant relies (i.e., exactly what Applicant intends the term
‘symptom severity quantification score’ to mean) are not recited in the
rejected claim(s).” Id. at 25. The Examiner notes Appellant never gives an
explicit definition for this term, and thus this term is simply interpreted to be
any value that can be produced as a result of a sensor being used to measure
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user performing some clinical test to show their severity of a disease. Id.
Regarding real time analysis,
Examiner notes DeVaul teaches the use of real-time
analysis and this it can be applied in various medical situations
Paragraph 0003). Further Salarian teaches all of the necessary
calculations and processing of sensor data as required by the
claims but is merely silent on the analysis being done in real-
time. DeVaul teaching the ability to process and the idea of
processing data in real-time is thus used to show that various
calculations such as those of Salarian could be done in real-time
and as stated in the office action would of ordinary skill in the art
would have been motivated to do so, so that diagnosis of the
patient can occur as soon as possible before further more severe
symptoms may arise and because it benefits people who have
chronic conditions that require continuous and proactive
monitoring.

Id.
The Examiner finds the Salarian “balance and gait deficits as well as a
neurological and musculoskeletal constraints . . . are symptoms/side effects
of a movement disorder and thus one would be looking at the severity of
these symptoms/side effects when looking at the severity of a movement
disorder.” Id. at 26 (citing Salarian ¶ 30). The Examiner finds Cowings
teaches the claimed ICC values and one of ordinary skill in the art to have
modified Salarian with Cowings because having excellent reliability is a
necessity in the medical field to help prevent false positives and false
negatives and since it has been held that discovering an optimum value of a
result effective variable involves only routine skill in the art, and Cowing
teaches an ICC of greater than 0.80 as being a scientific standard. Id. at 26
(citing In re Boesch, 617 F.2d 272 (CCPA 1980)). The Examiner finds
Huang teaches calculating MDC values based on a method of quantifying
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severity of a subject’s movement which Huang teaches as a known tool and
a crucial tool for interpretation of data which could thus be applied to the
combination of the other references as again Huang teaches the use of MDC
as being known in the art, and one of ordinary skill in the art would be able
to understand how to apply it to various situations whether using sensors or
not. Id. at 27 (citing Huang, p. 115, second paragraph).
In the Reply Brief, Appellant reiterates arguments including the
claimed invention yields unexpected exceptional results, including the ICC
values. Reply Br. 13.
During prosecution, claims must be given their broadest reasonable
interpretation when reading claim language in light of the Specification as it
would be interpreted by one of ordinary skill in the art. In re Am. Acad. of
Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). While we interpret
claims broadly but reasonably in light of the Specification, we nonetheless
must not import limitations from the Specification into the claims. See In re
Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). Our reviewing court
states that “the words of a claim ‘are generally given their ordinary and
customary meaning.’” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.
Cir. 2005) (en banc) (citations omitted). However, the broadest reasonable
interpretation differs from the broadest possible interpretation. In re Smith
Int’l, Inc., 871 F.3d 1375, 1383 (Fed. Cir. 2017). The correct inquiry in
giving a claim term its broadest reasonable interpretation in light of the
specification is “an interpretation that corresponds with what and how the
inventor describes his invention in the specification, i.e., an interpretation
that is ‘consistent with the specification.’” Id. at 1382–83 (quoting In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997)).
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Here, the Examiner’s interpretation of the disputed limitations of
claim 1 are broad, but reasonable, and we are not persuaded by Appellant’s
arguments to the contrary. On the record before us, applying the appropriate
claim interpretation, we agree with the Examiner’s findings that the
combination of references teaches “a symptom severity quantification
score,” “a system severity quantification algorithm,” “real time,” and
“symptom severity quantification score,” ICC of at least 0.80.” Final Act.
11–13 (citing Salarian ¶¶ 31–34; DeVaul ¶¶ 3, 14–18; Avinash ¶¶ 6, 7, 39,
40, 62, 81, 89, 90; Cowlings, 14:21–41).
We note much of Appellant’s arguments are unsupported by factual
evidence. Mere attorney arguments and conclusory statements that are
unsupported by factual evidence are entitled to little probative value. See In
re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); In re De Blauwe, 736 F.2d
699, 705 (Fed. Cir. 1984); Ex parte Belinne, Appeal 2009-004693, 2009 WL
2477843, at *3–4 (BPAI Aug. 10, 2009) (informative).
Along with the unreasonably narrow claim interpretations, supra,
Appellant also argues an unreasonably narrow teaching of Salarian, DeVaul,
Cowings, and Avinash to attempt to limit the teaching to the express
disclosures, and asserts an overly demanding standard of obviousness.
However, we note:
[t]he test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill in
the art.
In re Keller, 642 F.2d 413, 425 (CCPA 1981).
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As stated by the Supreme Court, the Examiner’s obviousness rejection
must be based on:
[S]ome articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness. . . . [H]owever, the
analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can
take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006)).
Neither the Examiner nor the Appellant has specifically addressed the
level of ordinary skill in the art. We will therefore consider the cited prior
art as representative of the level of ordinary skill in the art. See Okajima v.
Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific
findings on the level of skill in the art does not give rise to reversible error
‘where the prior art itself reflects an appropriate level and a need for
testimony is not shown.’” (quoting Litton Indus. Prods., Inc. v. Solid State
Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
Here, the Examiner provides sufficient evidence that one of ordinary
skill in the art would modify the Salarian system to include DeVaul real time
capability to enable real time diagnosis which benefits people who have
chronic conditions that require continuous and proactive monitoring. Final
Act. 10–11. These, and the additional cited references, discussed infra, are
generally concerned with the field of medicine, involving movement and
movement disorders. One of ordinary skill in the art would be interested in
achieving high reliability, such as that taught by Cowings. Moreover, the
Specification does not teach how the claimed ICC values are achieved, and
Appellant provides no persuasive evidence of unexpected results. Cowings
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is concerned with medicine and movement disorders, including
physiological responses in motion sickness, cardiovascular training,
hypertension, migraine, muscle tension, fecal incontinence, nauseagenic
effects of chemotherapy. See, e.g., for example, Cowings, 3:62–4:43; Fig. 2.
Additionally, Cowings is concerned with the common problem of employing
an acceptable statistical model for reliability. See, e.g., Cowings, 14:21–41.
As such, Cowings is both in the same field of endeavor and also reasonably
pertinent to the same problems faced by the inventor of this Application.
Therefore, we sustain the rejection of claim 1, and dependent claims 2
and 3 as Appellant relies on claim 1 arguments.
Dependent claims 22 and 23 recite “ICC of at least 0.95” and “at least
0.097,” respectively. As discussed, supra, these represent desirable values
similar to the ICC value of 0.80 recited in claim 1. Therefore, for the same
reasons, we sustain the rejections of claims 22 and 23.
Claim 4 over Salarian, DeVaul, Cowings, Avinash, Scott, and
Jeansonne
Dependent claim 4 recites “[t]he method of claim 1 wherein the at
least one sensor is user-programmable such that a user may define an
operating range in which the sensors will work, if the sensor is an
accelerometer it is programmable to operate between ±2g to± 16g”
(emphasis added). Although Appellant argues the Jeansonne reference does
not expressly teach the claimed range, we agree with the Examiner that the
cited combination of references teaches “[t]he method of claim 1 wherein
the at least one sensor is user-programmable such that a user may define an
operating range in which the sensors will work” and the term “if” precedes a
conditional limitation entitled to no patentable weight. Final Act. 13–14
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(citing Scott ¶ 23; Jeansonne ¶ 18); Appeal Br. 38–42; Ans. 27–28; Reply
Br. 15–16. The claim term “if” is conditional and, in a method claim, is
entitled to no patentable weight. Ex parte Schulhauser, Appeal No. 2013-
007847, at 9–10 (PTAB Apr. 28, 2016) (precedential).
Therefore, we sustain the rejection of claim 4.
Claim 5 over Salarian, DeVaul, Cowings, Avinash, Scott, and Chang
Dependent claim 5 recites “[t]he method of claim 4 wherein the
processor receiving the transmitted signal is a smartphone.”
The Examiner finds Chang teaches the use of a smartphone as a
processor and determines it would have been obvious to one of ordinary skill
in the art to have modified Salarian with Chang as Chang teaches these are
recognized equivalents for processing. Final Act. 14 (citing Chang ¶ 33).
The Examiner determines it would only require the routine skill of simple
substitution of one known element for another to obtain predictable results
of the processor of Salarian and the smartphone of Chang. Id. (citing MPEP
§ 2143 I. B).
Appellant argues that Chang does not remedy the deficiency,
discussed supra, of the cited references regarding claim 1, and makes similar
arguments regarding the Examiner’s suggested combination with Chang for
the limitation “smartphone.” Appeal Br. 45–47.
We agree with the findings and conclusion of the Examiner and are
not persuaded by Appellant’s arguments because they are similar to those
presented in the combination of cited references regarding claim 1 discussed
supra. Therefore, we sustain the rejection of claim 5.
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Claim 6 over Salarian, DeVaul, Cowings, Avinash, and Chang
Dependent claim 6 recites “[t]he method of claim 1 wherein the
processor receiving the transmitted signal is a tablet.”
The Examiner finds Chang teaches the use of a tablet as a processor
and it would have been obvious to one of ordinary skill in the art to have
modified Salarian with Chang as Chang teaches these are recognized
equivalents for processing and because it would only require the routine skill
of simple substitution of one known element for another to obtain
predictable results of the processor of Salarian with the tablet of Chang.
Final Act. 14–15 (citing Chang ¶ 33; MPEP § 2143 I. B).
We agree with the findings and conclusion of the Examiner and are
not persuaded by Appellant’s arguments because they are similar to those
presented in the combination of the cited references regarding claims 1 and 5
discussed supra. Therefore, we sustain the rejection of claim 6.
Claim 7 over Salarian, DeVaul, Cowings, Avinash, Scott, and McNeil
Claim 7 recites “[t]he method of claim 4 wherein the symptom
severity quantification scores are transmitted substantially simultaneously
with being calculated.”
The Examiner finds McNeil teaches the symptom severity
quantification scores are transmitted substantially simultaneously with being
calculated and it would have been obvious to one of ordinary skill in the art
to have modified Salarian with McNeil because it allows for quicker
diagnosis and quantification of a subject’s disorder. Final Act. 15 (citing
McNeil ¶ 183). The Examiner determines the modification would allow the
calculation of the symptom quantification score of Salarian and Avinash to
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be transmitted substantially simultaneously with being calculated by using
the calculation/transmitting teaching of McNeil. Id.
Appellant argues that McNeil does not remedy the deficiency,
discussed supra, of the cited references regarding claim 1, and makes similar
arguments regarding the Examiner’s suggested combination with McNeil for
the claim 7 limitation. Appeal Br. 47–50.
We agree with the findings and conclusion of the Examiner and are
not persuaded by Appellant’s arguments and, therefore, we sustain the
rejection of claim 7.
Claim 21 over Salarian, DeVaul, Cowings, Avinash, and Huang
Dependent claim 21 recites “[t]he method of claim 1, wherein the
non-postural symptom severity quantified by the calculated symptom
severity quantification score is selected from the group consisting of tremor,
bradykinesia, rigidity, gait/balance disturbances, and dyskinesias.”
In this rejection, the Examiner finds Salarian and Huang teach the
limitations and it would have been obvious to one of ordinary skill in the art
to have modified Salarian and Huang because those, such as gait and
balance, are known in the art symptoms of Parkinson’s. Final Act. 15 (citing
Salarian ¶¶ 4, 5, 8; Huang, 115, ¶ 2).
Appellant argues, although Salarian and Huang may disclose analysis
of one or more of the claimed symptoms, neither reference teaches
quantifying the severity of such symptoms by calculating a symptom
severity quantification score, as claimed. Appeal Br. 51–53. Appellant
argues the Examiner provides insufficient basis for the suggested
combination of the cited references. Id. at 51–52.
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We agree with the findings and conclusion of the Examiner and are
not persuaded by Appellant’s arguments because they are similar to those
arguments presented in the combination of cited references regarding claim
1 and 21, discussed supra. For the same reasons set forth above, we sustain
this rejection of claim 21.
Claims 8–10 and 24–26 over Salarian, DeVaul, Huang, and Avinash
Independent claim 8 is similar to claim 1 except that claim 8 recites
“wherein the method exhibits a real-time average minimal detectable change
(MDC) that represents a change of about 15% or less of the total scale of the
particular test corresponding to the calculated symptom severity
quantification score for repeated iterations of the method while the subject
performs the same test.” Claim 1 recites “wherein the method exhibits a
real-time-average intraclass correlation (ICC) of at least 0.80 corresponding
to the calculated symptom severity quantification score for repeated
iterations of the method while the subject performs the same test.”
The Examiner refers to Huang’s teaching calculating a MDC for TUG
tests and the values being about 15% or less. Final Act. 16–17 (citing
Huang, Table 2 and Data Analysis Section and Results Section). The
Examiner concludes it would have been obvious to one of ordinary skill in
the art to have modified Salarian with Huang because Huang teaches MDC
as being a measure that is crucial for the interpretation of data in both
research and clinical settings and enables clinicians and researchers to
determine whether a change score in a measure for an individual patient
represents a true change or is within the bounds of a random error thus
allowing them to provide better treatment. Id. at 17.
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Appellant’s arguments to the contrary are not persuasive and are
simply attorney arguments. We agree with the findings and conclusion of
the Examiner regarding the teachings of Salarian and Huang and are not
persuaded by Appellant’s arguments because they are similar to those
presented in the combination of cited references regarding claim 1, discussed
supra.
Therefore, we sustain the rejection of claim 8. We also sustain the
rejection of dependent claims 9 and 10 as these claims are similar to
dependent claims 2 and 3 discussed supra.
Dependent claim 24 depends from independent claim 8 and recites
“[t]he method of claim 8, wherein the non-postural symptom severity
quantified by the calculated symptom severity quantification score is
selected from the group consisting of tremor, bradykinesia, rigidity,
gait/balance disturbances, and dyskinesias.” Claim 24 recites the same
limitations as claim 21, which depends from claim 1, and is discussed supra.
The Examiner finds Salarian and Huang teaches the claim 24
limitations, and it would have been obvious to one of ordinary skill in the art
to have modified Salarian and Huang because those are known in the art
symptoms of Parkinson’s. Final Act. 17 (citing Salarian ¶¶ 4, 5, 8; Huang,
114, ¶ 1).
Appellant refers to claim 8 arguments and notes that the claim
specifies that it is the symptom severity that is being quantified by the
calculated symptom severity quantification score. Appeal Br. 63–65.
According to Appellant, although Salarian and Huang may disclose analysis
of one or more of the claimed symptoms, neither reference teaches
quantifying the severity of such symptoms by calculating a symptom
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severity quantification score, as claimed. Appellant argues Salarian
discloses measurements and metrics pertaining to raw sensor data
measurements.
We agree with the findings and conclusion of the Examiner and are
not persuaded by Appellant’s arguments because they are similar to those
presented in the combination of cited references regarding claims 1, 8, and
21, discussed supra.
Therefore, we sustain the rejection of claim 24.
Dependent claims 25 and 26 recite “[t]he method of claim 8, wherein
the method exhibits a real-time average minimal detectable change (MDC)
that represents a change of about 5% or less [or about 2% or less recited in
claim 26] of the total scale of the particular test corresponding to the
calculated symptom severity quantification score for repeated iterations of
the method while the subject performs the same test.”
The Examiner finds Salarian is silent on the MDC being about 5% or
less or about 2% or less, and the Specification provides no technical details
on how the values for the MDC are achieved. Final Act. 18. According to
the Examiner, it would have been obvious to one of ordinary skill in the art
to have gotten the values to be at 5% or less or 2% or less since it has been
held that discovering an optimum value of a result effective variable
involves only routine skill in the art. Id. (citing In re Boesch, 617 F.2d 272
(CCPA 1980)). The Examiner determines one of ordinary skill in the art in
light of the teaching of Huang would acknowledge that intraclass correlation
is a known statistical model and thus one of ordinary skill in the art would be
able to alter the device/method of Salarian in various ways as is routine in
order to achieve the highest reliability possible. Id.
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Appellant refers to claim 8 arguments and argues the claimed system
and methods have displayed an unexpected exceptional performance for the
specifically claimed method based on the design and configuration of the
sensor device and the processor and algorithms employed. Appeal Br. 65–
69. According to Appellant, the claimed MDC values are a measure of this
unexpected performance, and are not a matter of design choice. Id. at 66.
As discussed supra regarding claims 1 and 8, we are not persuaded by
Appellant’s arguments. Again, we note the record before us provides
insufficient support for Appellant’s assertion of unexpected performance.
Therefore, we sustain the rejection of claims 25 and 26.
Claim 11 over Salarian, DeVaul, Huang, Avinash, Scott, and
Jeansonne
Claim 11 recites “[t]he method of claim 8, wherein the at least one
sensor is user-programmable such that a user may define an operating range
in which the sensors will work, if the sensor is an accelerometer it is
programmable to operate between ±2g to ±16g.”
As in the rejection of claim 4, discussed supra, claim 11 includes
conditional language “if” and for the same reasons, we sustain the rejection
of claim 11.
Claims 12 and 13 over Salarian, DeVaul, Huang, Avinash, and Chang
Claims 12 (“smartphone’) and 13 (“tablet”) correspond respectively to
claims 5 and 6, discussed supra. We sustain the rejection of claims 12 and
13 for the same reasons.
Claim 14 over Salarian, DeVaul, Huang, Avinash, Scott, and McNeil
Claim 14 recites “[t]he method of claim 11 wherein the symptom
severity quantification score is transmitted substantially simultaneously with
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being calculated” and corresponds to claim 7, discussed supra. We sustain
the rejection of claim 14 for the same reasons.

In view of the above, we sustain the rejections of claims 1–14 and
21–26.

CONCLUSION
We affirm the Examiner’s decision rejecting claims 1 and 8 under
35 U.S.C. § 112(a) written description.
We affirm the Examiner’s decision rejecting claims 1 and 8 under
35 U.S.C. § 112(a) enablement.
We reverse the Examiner’s decision rejecting claims 1, 8, 22, 23, 25,
and 26 under 35 U.S.C. § 112(b) indefiniteness.
We affirm the Examiner’s decision rejecting claims 1–14 and 21–26
under 35 U.S.C. § 101.
We affirm the Examiner’s decision rejecting claims 1–14 and 21–26
under 35 U.S.C. § 103.

DECISION

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 8 112(a) Written Description 1, 8
1, 8 112(a) Enablement 1, 8
1, 8, 22, 23,
25, 26
112(b) Indefiniteness 1, 8, 22, 23,
25, 26
1−14,
21−26
101 Eligibility 1–14,
21–26

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1–3, 21–23 103(a) Salarian, DeVaul,
Cowings, Avinash
1–3,
21–23

4 103(a) Salarian, DeVaul,
Cowings, Avinash,
Scott, Jeansonne
4
5 103(a) Salarian, DeVaul,
Cowings, Avinash,
Scott, Chang
5
6 103(a) Salarian, DeVaul,
Cowings, Avinash,
Chang
6
7 103(a) Salarian, DeVaul,
Cowings, Avinash,
Scott, McNeil
7
21 103(a) Salarian, DeVaul,
Cowings, Avinash,
Huang
21
8–10,
24–26
103(a) Salarian, DeVaul,
Avinash, Huang
8–10,
24–26

11 103(a) Salarian, DeVaul,
Huang, Avinash,
Scott, Jeansonne
11
12, 13 103(a) Salarian, DeVaul,
Huang, Avinash,
Chang
12, 13
14 103(a) Salarian, DeVaul,
Huang, Avinash,
Scott, McNeil
14
Overall
Outcome
1–14,
21–26

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
See 37 C.F.R. § 1.136(a)(1)(iv) (2011).

AFFIRMED