Victor Pedro

Patent Trials and Appeals Board

Feb 1, 2021

2020003459 (P.T.A.B. Feb. 1, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/284,864 05/22/2014 Victor M. Pedro 3958/1002 9160
2101 7590 02/01/2021
Sunstein LLP
100 High Street
Boston, MA 02110-2321
EXAMINER
JENNESS, NATHAN JAY
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
02/01/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
usptomail@sunsteinlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VICTOR M. PEDRO
Appeal 2020-003459
Application 14/284,864
Technology Center 3700
Before BENJAMIN D. M. WOOD, BRANDON J. WARNER, and
LEE L. STEPINA, Administrative Patent Judges.
WOOD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 4, 7, 10, and 15, which constitute all
the claims pending in this application. See Final Act. 1. Claims 2, 3, 5, 6, 8,
9, and 11–14 have been cancelled. An oral hearing in accordance with 37
C.F.R. § 41.47 was held on January 14, 2021, a transcript of which will be

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies the real party in interest as Rhode Island Integrated
Medicine. Appeal Br. 3.
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entered into the record in due course. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
CLAIMED SUBJECT MATTER
The claims are directed to a method for treating a subject having post-
concussion syndrome. Sole independent claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A method of treating a subject having post-concussion
syndrome (PCS), the method providing a protocol comprising:
identifying post-concussion syndrome in the subject;
selecting a plurality of distinct postures, to be sequentially
assumed by the subject, from a posture set of walking, standing,
sitting, and supine;
selecting a plurality of distinct stimuli, to which the
subject will be sequentially subjected, from a stimulus set of
TENS, non-painful heat, non-painful cold, visual, occulomotor
stimulation, crude touch, olfactory stimulation, vestibular
stimulation, and auditory stimulation;
selecting an autonomic physiological response parameter,
to be quantitatively measured as of when the subject is subjected
to each selected stimulus, from the response parameter set of
oxygen saturation, heart rate, pupillary response, blood pressure,
sweat production, pseudomotor activity, and respiration;
having the subject sequentially assume each selected
posture;
in each of the selected postures, subjecting the subject to
each of the selected stimuli sequentially, quantitatively
measuring the selected autonomic physiological response
parameter as of when the subject has been subjected to each of
the selected stimuli, and recording each of the quantitative
measures in association with the corresponding posture and
stimulus;
analyzing the recorded quantitative measures to identify
the posture with respect to which the subject exhibits a least
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amount of dysfunction relative to a statistical norm, and identify
the stimulus with respect to which the subject exhibits a least
amount of dysfunction relative to the statistical norm when in the
identified posture;
repeatedly:
subjecting the subject to the identified stimulus
while the subject is in the identified posture and while using an
instrument to provide a quantitative measure of the selected
autonomic physiological response parameter as of each instance
when the subject has been subjected to the identified stimulus,
and
recording each of the quantitative measures relating
to each such instance, until the recorded quantitative measures
indicate that a desired endpoint physiological condition has been
achieved approaching normalcy relative to the statistical norm;
upon achievement of the desired endpoint physiological
condition, having the subject assume a posture different from the
identified posture, and, when the subject is in such posture,
subjecting the subject to one of the selected stimuli while using
the instrument to provide a quantitative measure of the selected
autonomic physiological response parameter and recording the
quantitative measure for the different posture;
analyzing the recorded quantitative measure for the
different posture to determine whether there is a dysfunction in
response of the subject, relative to a further statistical norm, to
the one of the selected stimuli; and
upon existence of such a dysfunction, repeatedly
subjecting the subject to the one of the selected stimuli at the
different posture until a further desired endpoint physiological
condition is achieved approaching normalcy relative to the
further statistical norm, wherein the post-concussion syndrome
is associated with at least one symptom selected from the group
consisting of headaches, dizziness, neck pain, stiff neck, cold
sweats, excessive eye sensitivity to light and combinations
thereof, the treatment resulting in a decrease in the at least one
symptom, and wherein the foregoing protocol promotes
thalamocortical pathways within the brain.
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REJECTION
Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis
1, 4, 7, 10, 15 101 Eligibility

OPINION
I. PRINCIPLES OF LAW
To determine whether a claim falls within a judicially recognized
exception to patent eligibility under 35 U.S.C. § 101, we apply the two-step
framework set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012), and reaffirmed in Alice Corporation
Proprietary LTD. v. CLS Bank International, 573 U.S. 208 (2014). For the
first Alice step (Step 2A of the USPTO’s Patent Subject Matter Eligibility
guidance, MPEP § 2106), we determine whether the claims at issue are
directed to a patent-ineligible concept such as an abstract idea, law of nature,
or natural phenomenon. Alice, 573 U.S. 208 (citing Mayo, 566 U.S. at 78–
79). If so, we advance to the second Alice step (Step 2B of the USPTO’s
Patent Subject Matter Eligibility guidance) where “we consider the elements
of each claim both individually and ‘as an ordered combination’ to
determine whether the additional elements ‘transform the nature of the
claim’ into a patent-eligible application” of the otherwise patent-ineligible
concept. Id. (quoting Mayo, 566 U.S. 78–79).
We also follow the USPTO’s additional guidance on applying Step
2A. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
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Reg. 50 (Jan. 7, 2019) (“Revised Guidance”).2 The Revised Guidance
establishes a “two-prong inquiry” for determining whether a claim is
directed to a judicial exception. Id. at 54. In prong one, we determine
whether the claim recites a judicial exception, such as a law of nature,
natural phenomenon, or abstract idea. Id. If so, we look to whether the
claim recites additional elements that integrate the judicial exception into a
practical application. Id. at 50. Thus, a claim is directed to a judicial
exception only if the claim recites a judicial exception and does not integrate
that exception into a practical application. Id. Relevant to this case, the
Revised Guidance instructs that an additional limitation that “applies or uses
a judicial exception to effect a particular treatment or prophylaxis for a
disease or medical condition” may integrate the judicial exception into a
practical application. Id. at 55.
If we determine that the judicial exception is not integrated into a
practical application, we proceed to Step 2B and determine whether the
claim adds a specific limitation beyond the judicial exception that is not
well-understood, routine, and conventional activity in the field, or,
alternatively, whether the claim simply appends well-understood, routine,
and conventional activities previously known to the industry, specified at a
high level of generality, to the judicial exception. Id. at 56.
II. DISCUSSION
A. The Examiner’s and Appellant’s Positions
For Step 2A, Prong 1, the Examiner finds that:

2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01-
07/pdf/2018-28282.pdf.
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the claims describe the natural correlation of postures and
stimuli to autonomic response and determining a desired
endpoint which involve the mental process of forming a
judgment/observation/evaluation/opinion of the amount of
dysfunction present in a human subject and at to when an
endpoint physiological condition is achieved as well as
organizing human activity by having a human subject
following instructions presented by a physician/himself.
Final Act. 9. For Step 2A, Prong 2, the Examiner finds that
the claims are not considered to be directed towards a particular
treatment . . . The exception/natural correlation is defined as
the treatment, and the remaining limitations are considered
nominal or field of use/extra-solution activity because they
merely indicate autonomic responses to stimuli should be
evaluated on a subject identified as having post-concussion
syndrome. The claims do not contain specific steps for
identifying post-concussion syndrome and do not describe a
particular treatment. The claims merely recite a desired
endpoint physiological condition. Again, this indicates that any
non-particular “treatment” resulting in a return toward “normal”
autonomic responses, e.g. lowering heart rate from an elevated
state, results in the treatment of post-concussion syndrome.
Id. at 9–10. For Step 2B, the Examiner finds that “[t]he claims do not
include additional elements that are sufficient to amount to significantly
more than the judicial exception because the claims are not required to be
performed on a particular machine, do not transform an article, describe a
naturally occurring correlation, and relate to a general concept.” Id. at 7.
Appellant responds that “[b]ecause the claims at issue on appeal are
directed to a method of treatment that practically applies a natural
relationship to effect a particular treatment for a medical condition, they are
patent eligible.” Appeal Br. 7 (citing Vanda Pharm. Inc. v. West-Ward
Pharm., 887 F.3d 1117, 1135 (Fed. Cir. 2018)). Appellant asserts that
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claim 1 recites a series of treatment steps to treat post-concussion syndrome.
Id. According to Appellant, the claimed steps “have a transformative effect
on the brain,” e.g., “promot[ing] thalamocortical pathways within the brain.”
Id. at 8.
A. Analysis
1. Step 2A, Prong 1
We agree with the Examiner that claim 1 recites a judicial exception.
For example, the steps of “selecting a plurality of distinct postures” from the
claimed “posture set,” “selecting a plurality of distinct stimuli” from the
claims “stimulus set,” and “selecting an autonomic physiological response
parameter from a “response parameter set” concern judgments that can be
performed in the human mind, and therefore fall within the mental-process
grouping of abstract ideas. Revised Guidance, 84 Fed. Reg. at 52. Further,
the steps directed to having the subject assume various postures relate to
managing personal behavior, which falls within the certain-methods-of-
organizing-human-activity grouping of abstract ideas. Id. Accordingly, we
proceed to Prong 2 to determine whether additional elements integrate the
judicial exception into a practical application of the judicial exception.
2. Step 2A, Prong 2
As noted above, the Revised Guidance states that an element that
“applies or uses a judicial exception to effect a particular treatment or
prophylaxis for a disease or medical condition” may integrate a recited
judicial exception into a practical application. The Revised Guidance cites
in part to Vanda in support of this proposition. In Vanda, the claims at issue
involved a method of treating persons with schizophrenia, where the method
first required performing a genetic test to determine the person’s ability to
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metabolize iloperidone and other drugs (i.e., the patient’s “CYP2D6
metabolizer genotype”), and then administering a particular dose of
iloperidone based on the results of the test; a lower dose of iloperidone is
administered to patients with lower CYP2D6 activity comparing with those
with normal CYP2D6 activity to avoid a potentially harmful side effect of
the drug. Vanda, 887 F.3d at 1121, 1134. The court determined that the
claims “are not directed to patent-ineligible subject matter” because they
included specific steps to treat a particular disease. Id. at 1134. The court
contrasted Vanda’s claims with those at issue in Mayo, which, even though
they recited administering a drug to a patient, they did so only as a
diagnostic method “based on the ‘relationships between concentrations of
certain metabolites in the blood and the likelihood that a dosage of [the] drug
will prove ineffective or cause harm.’” Id. (quoting Mayo, 566 U.S. at 77).
The court characterized Mayo’s claims as directed to the “entirely natural
process” of the body’s metabolizing of the drug. Id. (citing Mayo, 566 U.S.
at 77).
We agree with Appellant that claim 1 is drawn to a method of
treatment rather than a diagnostic method, and therefore is patent eligible
under Vanda. While the claimed method requires measuring a subject’s
autonomic physiological responses to various stimuli while the patient
assumes various postures (to determine an optimal combination of posture
and stimulus for treatment), the claim also requires that the patient be
repeatedly subjected to the selected stimulus while in the selected posture
until the autonomic physiological response changes to a desired endpoint
physiological response, i.e., until the autonomic response “approach[es]
normalcy relative to [a] statistical norm.” Appeal Br. 16–17 (claims app.).
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The Specification explains that “different body postures affect the autonomic
nervous system differently, and therefore various external stimuli may have
different therapeutic efficacies when a patient or subject is in each body
posture.” Spec. ¶ 8. Repeatedly subjecting the patient to the selected
stimulus while in the selected posture “stimulates the nervous system,”
thereby promoting “the formation of pathways that help transfer information
throughout the brain” to improve “overall brain function.” Id. The repeated
application of the stimulus to change an autonomic response, as claimed,
distinguishes this claim from one that would merely measure a pre-existing
autonomic response.
The Examiner asserts that the claims at issue here are distinguishable
from the claims found to be patent eligible in Vanda because “the treatment
steps in the present claim are identical to the diagnostic steps.” Final Act. 3.
We disagree. As stated above, the diagnostic steps are performed to select
the optimum combination of posture and stimulus based on pre-treatment
autonomic responses to multiple stimuli as the patient alternates between
multiple postures; conversely, the treatment steps then repeatedly subject the
patient to the selected stimuli while in the selected posture to eventually
change the autonomic response, which evidences the formation of
“thalamocortical pathways within the brain.” Appeal Br. 18 (claims app.).
The Examiner further asserts that the present claims are
distinguishable from Vanda because they “involve only natural correlations
invoked . . . by stimuli received by humans in everyday life.” Final Act. 3.
It is true that, for example, a person may experience “non-painful cold”
while “sitting.” See Appeal Br. 16 (claims app.). But, again, claim 1 goes
beyond simply measuring a response to a stimulus in a particular posture,
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and instead includes steps designed to change a person’s response to a
stimulus.
The Examiner further argues that “[t]he treatment steps may be
applied entirely by hand.” Final Act. 3. It is true that the claimed set of
stimuli includes “crude touch,” which arguably can be performed by hand.
But the Examiner has not provided legal support for the notion that patent-
eligible treatment methods must involve a pharmaceutical, or at least cannot
be performed by hand. To the extent that this argument is a reflection of the
Examiner’s determination that the claims fail the machine-or-transformation
test for patent eligibility (Final Act. 4), we note that a claim may be patent
eligible even if it fails this test. Bilski v. Kappos, 561 U.S. 593, 604 (2010).
The Examiner also asserts that the claims “do not require a particular
end result to define the treatment i.e. treatment is considered rendered if
there is any movement of an autonomic response towards a statistical norm.”
Final Act. 3. We disagree that the claims do not require an end result; on the
contrary, they require application of the selected stimulus until an autonomic
physiological response changes such that it approaches “normalcy relative to
[a] statistical norm.” Appeal Br. 16 (claims app.). We further note that the
representative claim in Vanda does not require any particular end result
(Vanda, 887 F.3d at 1121), and was nonetheless determined to be patent
eligible.
CONCLUSION
The Examiner’s rejection is reversed.
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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4, 7, 10,
15
101 Eligibility 1, 4, 7, 10,
15

REVERSED