Steven Pashko LLC

Patent Trials and Appeals Board

Jun 1, 2020

2019003258 (P.T.A.B. Jun. 1, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/351,561 04/12/2014 Steven Michael Pashko PASH003USNP 4222
10879 7590 06/01/2020
Pinnacle IP Strategies, LLC
PO Box 2498
cinnaminson, NJ 08077
EXAMINER
TIEDEMAN, JASON S
ART UNIT PAPER NUMBER
3626
MAIL DATE DELIVERY MODE
06/01/2020 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 STEVEN MICHAEL PASHKO
Appeal 2019-003258
Application 14/351,561
Technology Center 3600
Before JEREMY J. CURCURI, MICHAEL M. BARRY, and
IFTIKHAR AHMED, Administrative Patent Judges.
AHMED, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 88–91, 98–100, and 103–116, which are all of the
claims pending in the application. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Steven Pashko, LLC as the real party
in interest. Appeal Br. 3.
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TECHNOLOGY
The claims relate to predicting placebo response or response shift in
people undergoing assessment of health or therapeutic treatment. Spec. ¶ 1.
ILLUSTRATIVE CLAIM
Claim 88 is illustrative:
88. A method for determining the likelihood that a candidate for
a biomedical or health-related research study (“clinical trial”)
will respond to a placebo used in the clinical trial, the method
comprising the steps of:
establishing a baseline of a candidate’s perception of what
constitutes their own body (“bodily self-image”) by
administering a first assessment comprising administering
questions via paper and pencil or computerized questionnaires
about what constitutes the candidate’s own body;
subjecting the candidate to a sensory experience
comprising a visual illusion, visual effects, or digital imagery
during which the candidate is exposed to a simulated or artificial
body or body part positioned relative to the candidate so as to
challenge the candidate’s perception of what constitutes their
own body; wherein the sensory experience involves the
candidate’s visual sense and at least one other sense, both of
which are stimulated;
administering a second assessment to determine the
candidate’s bodily self-image after the sensory experience, the
second assessment comprising administering questions via paper
and pencil or computerized questionnaires about what constitutes
the candidate’s own body;
comparing the candidate’s bodily self-image in the
baseline and the second assessment to determine the adaptability
of the candidate’s bodily self-image wherein the more the
candidate perceives that the artificial body or artificial body part
constitutes their own body, the more adaptable the candidate’s
bodily self-image is; and
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determining a likelihood that the candidate will respond
favorably to a placebo based on the adaptability of the
candidate’s bodily self-image;
wherein the adaptability of the candidate’s bodily self-
image:
a) comprises a measure of time required for,
duration of, intensity of, extent of, or any combination
thereof, the candidate’s response to the sensory
experience; or
b) is a function of
i) how life-like a simulated or artificial body
or body part used during the sensory experience is;
ii) position, relative to the participant, of a
simulated or artificial body or body part used during
the sensory experience; or
iii) timing of the stimulation of the visual
sense and at least one other sense during the sensory
experience.
REJECTION
Claims 88–91, 98–100, and 103–116 stand rejected under 35 U.S.C.
§ 101 as directed to a judicial exception without significantly more.
Non-Final Act. 3.
ISSUE
Did the Examiner err in concluding that claims 88–91, 98–100, and
103–116 are directed to a judicial exception without significantly more?
ANALYSIS
35 U.S.C. § 101 defines patentable subject matter, but the Supreme
Court has “long held that this provision contains an important implicit
exception” that “[l]aws of nature, natural phenomena, and abstract ideas are
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not patentable.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66, 70 (2012) (quotation omitted). “Eligibility under 35 U.S.C. § 101 is
a question of law, based on underlying facts.” SAP Am., Inc. v. InvestPic,
LLC, 898 F.3d 1161, 1166 (Fed. Cir. 2018). To determine patentable subject
matter, the Supreme Court has set forth a two-part test.
“First, we determine whether the claims at issue are directed to one of
those patent-ineligible concepts” of “laws of nature, natural phenomena, and
abstract ideas.” Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014). A
court must be cognizant that “all inventions at some level embody, use,
reflect, rest upon, or apply laws of nature, natural phenomena, or abstract
ideas” (Mayo, 566 U.S. at 71), and “describing the claims at . . . a high level
of abstraction and untethered from the language of the claims all but ensures
that the exceptions to § 101 swallow the rule.” Enfish, LLC v. Microsoft
Corp., 822 F.3d 1327, 1337 (Fed. Cir. 2016). Instead, “we evaluate the
focus of the claimed advance over the prior art to determine if the character
of the claim as a whole, considered in light of the specification, is directed to
excluded subject matter.” Trading Techs. Int’l, Inc. v. IBG LLC, 921 F.3d
1084, 1092 (Fed. Cir. 2019) (quotation omitted). “The inquiry often is
whether the claims are directed to ‘a specific means or method’ for
improving technology or whether they are simply directed to an abstract
end-result.” RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1326 (Fed.
Cir. 2017).
If the claims are directed to an abstract idea or other ineligible
concept, then we continue to the second step and “consider the elements of
each claim both individually and ‘as an ordered combination’ to determine
whether the additional elements ‘transform the nature of the claim’ into a
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patent-eligible application.” Alice, 573 U.S. at 217 (quoting Mayo, 566 U.S.
at 79, 78). The Supreme Court has “described step two of this analysis as a
search for an ‘inventive concept’—i.e., an element or combination of
elements that is sufficient to ensure that the patent in practice amounts to
significantly more than a patent upon the ineligible concept itself.” Id. at
217–18 (quotation omitted). However, “[t]he abstract idea itself cannot
supply the inventive concept, no matter how groundbreaking the advance.”
Trading Techs., 921 F.3d at 1093 (quotation omitted).
In 2019, the U.S. Patent & Trademark Office published revised
guidance on the application of § 101. USPTO, 2019 Revised Patent Subject
Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”);
USPTO, October 2019 Update: Subject Matter Eligibility, available at
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p
df (“Oct. Update”). Under that guidance, we look to whether the claim
recites
(1) a judicial exception, such as a law of nature or any of the
following groupings of abstract ideas:
(a) mathematical concepts, such as mathematical formulas;
(b) certain methods of organizing human activity, such as a
fundamental economic practice; or
(c) mental processes, such as an observation or evaluation
performed in the human mind;
(2) any additional limitations such that the claim as a whole
integrates the judicial exception into a practical application (see
MPEP § 2106.05(a)–(c), (e)–(h)); and
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(3) any additional limitations beyond the judicial exception that,
alone or in combination, were not “well-understood, routine,
conventional” in the field (see MPEP § 2106.05(d)).
See Guidance, 84 Fed. Reg. at 52, 55, 56.
USPTO Step 2A, Prong One
Prong 1 asks whether the claim recites an abstract idea, such as a
mental process. Here, claim 88 recites:
establishing a baseline of a candidate’s perception of what
constitutes their own body (“bodily self-image”) by
administering a first assessment comprising administering
questions via paper and pencil or computerized questionnaires
about what constitutes the candidate’s own body;
subjecting the candidate to a sensory experience
comprising a visual illusion, visual effects, or digital imagery
during which the candidate is exposed to a simulated or artificial
body or body part positioned relative to the candidate so as to
challenge the candidate’s perception of what constitutes their
own body; wherein the sensory experience involves the
candidate’s visual sense and at least one other sense, both of
which are stimulated;
administering a second assessment to determine the
candidate’s bodily self-image after the sensory experience, the
second assessment comprising administering questions via paper
and pencil or computerized questionnaires about what constitutes
the candidate’s own body;
comparing the candidate’s bodily self-image in the
baseline and the second assessment to determine the adaptability
of the candidate’s bodily self-image wherein the more the
candidate perceives that the artificial body or artificial body part
constitutes their own body, the more adaptable the candidate’s
bodily self-image is; and
determining a likelihood that the candidate will respond
favorably to a placebo based on the adaptability of the
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candidate’s bodily self-image . . . wherein the adaptability of the
candidate’s bodily self-image . . . comprises a measure of . . . or
is a function of . . . .
“[W]ith the exception of generic computer-implemented steps, there
is nothing in the claims themselves that foreclose them from being
performed by a human, mentally or with pen and paper.” Intellectual
Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016).
Here, other than the generic computer components discussed below
(specifically, the “computerized questionnaires”), the “establishing . . . by
administering,” “subjecting,” “administering,” “comparing,” and
“determining” steps can all be performed mentally, verbally, or with a pen
and paper. In fact, the “establishing . . . by administering” and
“administering” steps expressly recite the use of “paper and pencil” to
collect information.
Next, “comparing” one thing (a candidate’s bodily self-image in the
baseline) to another thing (the second assessment) is an evaluation that can
be performed in the human mind, or with pen and paper. In re BRCA1 &
BRCA2-Based Hereditary Cancer Test Pat. Litig., 774 F.3d 755, 763 (Fed.
Cir. 2014) (concluding that the concept of “comparing BRCA sequences and
determining the existence of alterations” is an “abstract mental process”);
Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016)
(holding that collecting and analyzing information fall within the realm of
abstract ideas).
The results from the comparing step are then used to “determine” the
adaptability of the candidate’s bodily self-image and “determine” a
likelihood that the candidate will respond favorably to a placebo based on a
number of factors. Making a determination based on the comparison is an
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evaluation, judgment, or opinion as to changes or similarities in assessment
data, which could be performed in the human mind, or with pen and paper.
Thus, the “determining” recitations in claim 88 are also mental processes
(concepts which could be performed in the human mind). As the Federal
Circuit has said, “analyzing information by steps people go through in their
minds,” without more, constitutes “mental processes within the abstract-idea
category.” Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146
(Fed. Cir. 2016) (quotation omitted); Guidance, 84 Fed. Reg. at 52. Claim
88 therefore recites mental processes, which are an abstract idea.
Lastly, the “subjecting” step recites subjecting the candidate to a
sensory experience, that is, administering a test to the candidate during
which the candidate is exposed to a simulated or artificial body or body part,
and observes visually and through one other sense, a visual illusion, visual
effects, or digital imagery. This step, under the broadest reasonable
interpretation, encompasses the candidate viewing an artificial body part
(with his or her view of the actual body part being blocked) while the
experimenter simultaneously touches the artificial body part and the
corresponding actual body part. Spec. ¶ 75. Such a test constitutes
“managing personal behavior . . . or interactions between people,” including
following instructions, which falls within “certain methods of organizing
human activity” that forms one grouping of abstract ideas. Guidance 52; see
also OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362 (Fed. Cir.
2015) (the concept of testing how potential customers responded to different
price offers is an abstract idea); Interval Licensing LLC v. AOL, Inc., 896
F.3d 1335, 1344 (Fed. Cir. 2018) (the act of providing someone additional
information is an abstract idea, such as “the nontechnical human activity of
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passing a note to a person who is in the middle of a meeting or
conversation”). Moreover, “[a]dding one abstract idea . . . to another
abstract idea . . . does not render the claim non-abstract.” RecogniCorp, 855
F.3d at 1327.
Accordingly, claim 88 recites an abstract idea.
USPTO Step 2A, Prong Two
Prong 2 asks whether the claim recites any additional limitations that
integrate the judicial exception into a practical application.
Appellant asserts that the claims are not directed to an abstract idea
but are “new and useful methods of identifying placebo responders,”
“employing real world steps,” such as “administration of a sensory
experience wherein two different senses are stimulated in a human being.”
Appeal Br. 35. According to Appellant, “[t]he claims are, on their face,
highly specific applications that provide a ‘new and useful’ solution to a
problem in the field.” Id. Appellant argues that “the character of the claims
on the whole is overwhelming[ly] of a specific, practical inventive
application of such ideas to solve a problem in industry (the healthcare
industry, and more specifically the clinical research industry).” Id. at 36.
Appellant argues that the evidence submitted supports that the claims
involve neither a clinical test nor an abnormal condition, and that the results
cannot be achieved by thinking about data.2 See id. at 42–51 (citing Ex. 1,
¶¶ 18, 19, 20, 22, 23; Ex. 2, ¶¶ 17, 19, 23, 24; Ex. 3, ¶¶ 56, 57); see also
Reply Br. 48–50.

2 In addition to a declaration from the inventor, Appellant submits two other
declarations in support of its arguments. See Exs. 1–3.
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We are not persuaded of Examiner error by Appellant’s argument that
the claims are directed to methods of improving clinical research studies and
data analysis. The Federal Circuit is clear that “[t]he abstract idea itself
cannot supply the inventive concept, no matter how groundbreaking the
advance.” Trading Techs. Int’l, Inc. v. IBG LLC, 921 F.3d 1084, 1093 (Fed.
Cir. 2019) (quotation omitted); INO Therapeutics LLC v. Praxair Distrib.
Inc., 782 F. App’x 1001, 1007 (Fed. Cir. 2019) (holding that an “invention
[that] does not improve treatment of the underlying conditions in question”
and “does not recite a specific method of treating the disease using an
improved set of specific doses” collapses into a claim focused on the
abstract idea); SmartGene, Inc. v. Adv. Biological Labs., SA, 555 F. App’x
950, 954 (Fed. Cir. 2014) (holding that a “method for guiding the selection
of a therapeutic treatment regimen for a patient” is directed to a mental
process). As discussed above, other than the recited “computerized
questionnaires,” which are provided as an alternative to “paper and pen”
questionnaires, the claim steps can be performed mentally or verbally, or are
directed to organizing human activity. Thus, Appellant cannot rely on the
abstract idea as providing significantly more. Moreover the “computerized
questionnaires” are claimed at a high level and do no more than automate a
question and answer system that could be done manually with a pen and
paper. See Credit Acceptance Corp. v. Westlake Servs., 859 F.3d 1044, 1055
(Fed. Cir. 2017) (“mere automation of manual processes using generic
computers does not constitute a patentable improvement in computer
technology”). The problem with which the claims are concerned is
determining whether a candidate’s condition is suitable for a placebo study
by evaluating a first and second assessment of the candidate’s bodily self-
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image. Those are the types of evaluations that medical professionals
routinely and consciously perform. See SmartGene, 555 F. App’x at 954–
55.
To the extent Appellant relies on statements by the three declarants
that the claimed invention is not directed to an abstract idea, the Federal
Circuit has clarified that “step one of the Alice framework does not require
an evaluation of the prior art or facts outside of the intrinsic record regarding
the state of the art at the time of the invention.” CardioNet, LLC v.
InfoBionic, Inc., 955 F.3d 1358, 1374 (Fed. Cir. 2020). Instead, “Alice step
one presents a legal question that can be answered based on the intrinsic
evidence.” Id. at 1372.
We are therefore not persuaded that any additional limitation, alone or
in combination, reflects an improvement in the functioning of a computer or
other technology. See MPEP §§ 2106.05(a), (b). Nor do the claimed steps
effect “a transformation or reduction of a particular article to a different state
or thing.” See MPEP §§ 2106.05(c).
Appellant also argues that the claims do not preempt the use of a
“sensory experience” in the areas of psychology research, study of extreme
neurological defects, and gaming/virtual reality given the specific
application claimed in the specific field. Appeal Br. 38, 39. We agree with
the Examiner, however, that preemption is not the test. Ans. 8–9. “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).
“Where a patent’s claims are deemed only to disclose patent ineligible
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subject matter under the Mayo framework, as they are in this case,
preemption concerns are fully addressed and made moot.” Id.
Therefore, claim 1 does not integrate the abstract idea into a practical
application.
USPTO Step 2B
This step asks whether the recited additional limitations beyond the
judicial exception were not “well-understood, routine, conventional.”
Appellant argues that the claim steps are not well-known, routine and
conventional because the claims involve enough else, applying the abstract
idea in the realm of tangible physical actions. Appeal Br. 60. Appellant
faults the Examiner for refusing to accept “the opinion evidence of experts”
that the claimed methods are not routine or well-known in the field of
healthcare. Id. at 60–64 (citing Ex. 1, ¶¶ 25, 26; Ex. 2, ¶¶ 26–28); Reply Br.
41–47, 50–51. Appellant and the declarants state that the steps as claimed
have never been known in the relevant field. Id. at 62; Exhibit 1, ¶ 26
(“Such an assessment has never been used in any clinical study or clinical
setting to my knowledge.”); Ex. 2, ¶ 28 (“It is unquestionable that if specific
methods to identify placebo responders were available or known, such
individuals would be treated with placebos and could have avoided the side
effect burden associated with active treatment, and such methods would
have been in widespread use.”).
In essence, Appellant argues that the claimed method is patent eligible
because it was not previously used to identify placebo responders. However,
that misstates the test. The “well-understood, routine, conventional” portion
of the test applies only to additional limitations beyond the abstract idea.
E.g., Mayo, 566 U.S. at 79–80 (“any additional steps consist of well-
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understood, routine, conventional activity already engaged in by the
scientific community; and those steps, when viewed as a whole, add nothing
significant beyond the sum of their parts taken separately” (emphasis
added)). As noted above, “[t]he abstract idea itself cannot supply the
inventive concept, no matter how groundbreaking the advance.” Trading
Techs., 921 F.3d at 1093 (internal quotation omitted); Cleveland Clinic
Found. v. True Health Diagnostics LLC, 859 F.3d 1352, 1363 (Fed. Cir.
2017) (“[E]ven such valuable contributions can fall short of statutory
patentable subject matter, as it does here.”).
In sum, neither Appellant nor the declarants identify any additional
limitations in claim 88 that when considered individually or in ordered
combination recite an inventive concept beyond the abstract idea.
Appellant contends independent claims 98 and 108 are patent-eligible
under § 101 for the same reasons as for claim 88, identifying specific
limitations that differ from those of claim 88. See Appeal Br. 52–54
(arguing based on claim 98’s recitation of “creating a modified clinical data
set by modifying the raw clinical data to identify, eliminate, or statistically
adjust data pertaining to those participants determined to have more
adaptable bodily self-images”), 55–58 (arguing based on claim 108’s
“establishing” and “eliminating” steps). Because the additionally identified
limitations are abstract for the same reasons discussed above for claim 88,
Appellant’s arguments with respect to claims 98 and 108 are unpersuasive.
Accordingly, we sustain the rejection under § 101 of claim 88, and
claims 89–91, 98–100 and 103–116, which Appellant argues are patentable
for similar reasons. See Appeal Br. 52–58; 37 C.F.R. § 41.37(c)(1)(iv).
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DECISION
The following table summarizes the outcome of the rejection:
Claims
Rejected 35 U.S.C. § Basis Affirmed Reversed
88–91, 98–100,
103–116
101 Eligibility 88–91, 98–
100, 103–
116

TIME TO RESPOND
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.
§ 1.36(a)(1)(iv).
AFFIRMED