Pedro, Victor M.

Patent Trials and Appeals Board

Aug 3, 2020

14033004 - (D) (P.T.A.B. Aug. 3, 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.
14/033,004 09/20/2013 Victor M. Pedro 3958/1001 3585
2101 7590 08/03/2020
Sunstein LLP
100 High Street
Boston, MA 02110-2321
EXAMINER
JENNESS, NATHAN JAY
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
08/03/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
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 2019-004855
Application 14/033,004
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 January 16, 2018 Final Action rejecting claims 1, 4, 7, 10, and
15–17. See Final Act. 1. An oral hearing in accordance with 37 C.F.R.
§ 41.47 was held on July 23, 2020, a transcript of which will be entered into
the record in due course. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to the applicant as defined by 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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CLAIMED SUBJECT MATTER
The claims are directed to a method for treating a subject with
traumatic brain injury. Claim 1, reproduced below, is illustrative of the
claimed subject matter:
1. A method of treating a subject with traumatic brain injury by
stimulation of afferent fibers so as indirectly to cause
improvement in the area of the brain affected by the injury, and
in overall brain function, the method providing a protocol
comprising:
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;
having the subject sequentially assume each selected
posture;
in each of the selected postures, subjecting the subject to
each of the selected stimuli sequentially, while measuring a set
of autonomic physiological responses of the subject, to such
stimulation, the set having at least one member and selected
from the group consisting of oxygen saturation, heart rate,
pupillary response, blood pressure, sweat production,
pseudomotor activity, and respiration;
evaluating the autonomic physiological responses in each of
the selected postures to identify the posture wherein the
autonomic physiological responses of the subject exhibit a least
amount of dysfunction relative to corresponding statistical
norms for such responses;
identifying the stimulus with respect to which the
autonomic physiological responses of the subject exhibit a
change in the amount of dysfunction towards corresponding
statistical norms for such responses when in the identified
posture;
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repeatedly subjecting the subject to the identified stimulus
while the subject is in the identified posture until a desired
endpoint physiological condition is achieved in which the
autonomic physiological responses to the identified stimulus
approach a state of normalcy relative to corresponding
statistical norms for such responses;
upon achieving the desired endpoint physiological
condition, for at least one posture different from the identified
posture, subjecting the subject to a stimulus selected from the
stimulus set and determining whether the autonomic
physiological responses of the subject to the stimulus selected
at the different posture exhibit dysfunction relative to
corresponding statistical norms for such responses; and
upon existence of such a dysfunction, repeatedly subjecting
the subject to the stimulus selected at the different posture until
a further desired endpoint physiological condition is achieved
in which the autonomic physiological responses to the stimulus
selected at the different posture approach a state of normalcy
relative to corresponding statistical norms for such responses,
wherein the foregoing protocol promotes thalamocortical
pathways within the brain.
REJECTION
Claims Rejected 35 U.S.C. § Reference(s)/Basis
1, 4, 7, 10, and 15–17 101 Ineligible Subject Matter
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
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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.
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, inter alia,
“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.

2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01-
07/pdf/2018-28282.pdf.
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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 Parties’ Positions
The Examiner finds that the claims “are directed to a method for
treating a subject with brain injury by having the subject perform movement
during the application of stimuli under the direction of the physician,” and
therefore “claim an abstract idea.” Final Act. 3. The Examiner also finds
that the claims are directed to “a naturally occurring correlation between the
application of sensory stimuli and autonomic physiological responses.” Id.
at 4. The Examiner determines that the elements of the claims do not
transform the judicial exceptions into a patent-eligible application because
the claims “are not required to be performed on a particular machine” and
“do not transform an article.” Id. at 3 (citing In re Bilski, 545 F.3d 943, 954
(Fed. Cir. 2009)). According to the Examiner:
Under the broadest reasonable interpretation of the claims, each
step of the claims could be performed mentally or by hand. A
physician could direct a subject to assume various postures
(walking, standing, etc. . . .), measure an autonomic response
(heart rate, respiration, etc. . . .) manually or with known
measurement devices, and evaluate the physiological response
of the subject.
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Id. at 4.
Appellant responds that, “[b]ecause the claims at issue on appeal are
directed to a method of treatment, 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 the claims on appeal are directed to a
method of treating traumatic brain injury that “affect[s] the autonomous
physiological condition of the subject and that have a transformative effect
on the brain.” Id.
The Examiner disputes that the claims are directed to a treatment
method, and asserts that they are distinguishable from the claims at issue in
Vanda. Ans. 10–11. According to the Examiner, “the Office considers one
of the distinctions the fact that the treatment steps in the present claim are
identical to the diagnostic steps of the present claims and both the diagnostic
and treatment steps involve only natural correlations invoked, in the broadest
reasonable interpretation of the claim, by stimuli received by humans in
everyday life.” Id. at 9. The Examiner asserts that “[t]he treatment steps
may be applied entirely by hand, are not specific, and 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.” Id. at 10. The Examiner also notes that “[t]he method
steps are not limited to treatment of a specific medical condition (there is no
step of identifying a patient with a traumatic brain injury).” Id. at 13.
B. 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
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claimed “posture set,” and “selecting a plurality of distinct stimuli” from the
claims “stimulus 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
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
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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 characterizes 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 initially 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] a
state of normalcy relative to corresponding statistical norms for such
responses.” Appeal Br. 15–16 (claims app.). 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
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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.” Ans. 9. 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 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. 15–16 (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.” Ans. 9. It is
true that, for example, a person may experience “non-painful cold” while
“sitting.” But, again, the claim goes beyond simply measuring a response to
a stimulus in a particular posture, 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.” Ans. 9. 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
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Examiner’s determination that the claims fail the machine-or-transformation
test for patent eligibility (Final Act. 3), we note that a claim may be patent
eligible even if it fails this test. Bilski, 561 U.S. at 604.
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.”
Ans. 10. 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 “a state of normalcy
relative to corresponding statistical norms for such responses.” 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.
Finally, the Examiner argues that “[t]he method steps are not limited
to treatment of a specific medical condition (there is no step of identifying a
patient with a traumatic brain injury).” Ans. 13 (emphasis omitted). But the
claims here are limited to a method of treating traumatic brain injury to the
same extent that the claims in Vanda were limited to treating patients with
schizophrenia. That is, the representative claim considered by the Vanda
court also did not include a step of identifying a patient with schizophrenia.
See Vanda, 887 F.3d at 1121.
CONCLUSION
The Examiner’s rejection is reversed.
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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4, 7, 10,
15–17
101 Ineligible Subject
Matter
1, 4, 7, 10,
15–17
REVERSED