Ex Parte John et al

Patent Trial and Appeal Board

Apr 27, 2016

12744549 (P.T.A.B. Apr. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121744,549 07/15/2010 Erwin Roy John
30636 7590 04/27/2016
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
50124/04203 3367
EXAMINER
BERHANU, ETSUB D
ART UNIT PAPER NUMBER
3735
MAILDATE DELIVERY MODE
04/27/2016 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 ERWIN ROY JOHN and LESLIE S. PRICHEP 1
Appeal2014-004733
Application 12/744,549
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
device and a method for assessing efficacy of therapeutic agents. The claims
are rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is New York University
(App. Br. 2).
Appeal2014-004733
Application 12/744,549
STATEMENT OF THE CASE
The Specification describes a device and a method for assessing an
effect of a therapeutic agent that purport to estimate a probability that a
baseline profile corresponds to a predetermined pathophysiological
condition (Spec. i-f 4). Claims 1-20, 22, and 23 are on appeal. Claim 1 is
illustrative and reads as follows (emphasis added):
1. A method for assessing an effect of a therapeutic agent,
comprising the steps of:
detecting, via a computing device, brain electrical activity
of a subject to generate a first set of brain wave data;
extracting, via the computing device, from the first set of
brain wave data first data features sensitive to a neurological
disorder; and
comparing, via a central processing unit, the first data
features to control data to define a baseline profile of brain
electropathophysiology; and
computing, via the central processing unit, a first
quantitative score indicative of a probability that the baseline
profile corresponds to a predetermined pathophysiological
condition.
Claims 1-20, 22, and 23 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Suffin. 2
2 Suffin et al., US 2003/0135128 Al, published July 17, 2003.
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Application 12/744,549
Findings ofFact
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-7). For clarity, we highlight the
following.
FF 1. Suffin discloses that "[t]he present invention relates to the field
of electroencephalography (EEG), and more specifically includes methods
and systems for selecting therapies for behaviorally-diagnosed psychiatric
conditions and for predicting outcomes from therapies." (Suffin i-f 2; see
also Ans. 2.)
FF 2. Suffin discloses that "[t]he present invention is based, in part,
upon the inventors' discoveries that quantitative neurophysiologic
information, preferably including quantitative electrophysiologic
information, is a reliable indicator by which to choose therapies for
individuals with behaviorally-diagnosed psychiatric conditions and to
predict outcomes from selected therapies." (Suffin i-f 51; see also Ans. 5, 7.)
FF 3. Suffin discloses that "therapies for behaviorally-diagnosed
psychiatric conditions are selected according to the indications of
quantitative neurophysiologic information. . . . Thus, this invention provides
a method and system for improving the likelihood of selecting an effective
treatment the first time, with or without a preceding traditional diagnosis of
a mental disorder." (Suffin i-f 53 (emphasis added); see also Ans. 5, 7.)
FF 4. Suffin discloses that "[p]referably (and not limiting), the
individuals in the database have a behaviorally-diagnosed psychiatric
condition" (Suffin i-f 56; see also Ans. 7). Suffin further discloses that the
database "can include additional data on each individual, for example, the
traditional behavioral diagnosis" (Suffin i-f 56; see also Ans. 7).
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Appeal2014-004733
Application 12/744,549
FF 5. Suffin discloses that
"Z-scores," a type of normalization transformation, are uniform
differential probability scores. The difference between an
observed neurophysiologic value and the expected reference
mean, such as "age-adjusted normal" mean divided by the
expected reference standard deviation, such as "age-adjusted
normal" standard deviation yields a Z-score corresponding to the
observed neurophysiologic value.
(Suffin f 80; see also Ans. 6.)
FF 6. Suffin discloses
An EEG/QEEG instrument, such as the Spectrum 32,
manufactured by Caldwell Laboratories, Inc. (Kennewick,
Wash.), readily executes these univariate neurometric Z
transformations .... The instrument subsequently evaluates the
probability that the observed value in the patient belongs to the
"normal" group, taking into account the distribution of values in
the "normal" group.
(Suffin i-f 97; see also Ans. 2, 4.)
FF 7. Suffin discloses
The Z-score, obtained by comparing an individual patient's
QEEG information with the information for the reference
asymptomatic population, represents the patient's statistical
deviation from the reference-asymptomatic database. Thus, if a
patient's Z-score for a particular measure does not statistically
deviate from the reference asymptomatic population, the patient
would be determined to be "asymptomatic" for that measure.
However, if a patient's Z-score statistically deviates from the
reference population for a particular measure, the patient is
determined to be symptomatic for that measure. Notably, mere
examination of a Z-score reveals the extent of deviation since a
value of greater than one indicates a deviation of more than one
standard deviation from the expected mean.
(Suffin i-f 98; see also Ans. 2, 4, 6.)
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Appeal2014-004733
Application 12/744,549
Analysis
We agree with the Examiner that the claims are anticipated by Suffin
(Ans. 2-7; FF 1-7). We address Appellants' arguments below.
Appellants contend that "Suffin fails to teach or suggest a central
processing unit computing 'a first quantitative score indicative of a
probability that the baseline profile corresponds to a predetermined
pathophysiological condition"' because it does not disclose "determining a
probability that a patient has a pathophysiological condition" (App. Br. 4;
see also Reply Br. 2). Appellants assert that Suffin instead "compares
subject neurophysiological information to like data from other subjects" and
uses treatment response data from those like subjects "to estimate how the
subject will respond to a treatment" (App. Br. 4). Appellants further argue
that Suffin teaches away from a system wherein EEG is used for diagnosis
(App. Br. 4--5; Reply Br. 3--4). Lastly, Appellants assert that Suffin's
calculation of a Z-score "is simply a normalized score based on a reference
population and is not indicative of a measure of probability much less a
probability that a baseline profile corresponds to a predetermined
pathophysiological condition" (App. Br. 6; see also Reply Br. 3-5).
We are not persuaded. As an initial matter, we agree with the
Examiner that the claims do not require the determination of a probability
that a patient has a pathological condition. Rather, as the claims recite, it is
only necessary that "a first quantitative score indicative of a probability that
the baseline profile corresponds to a predetermined pathophysiological
condition" be computed (Ans. 5---6) (emphasis added).
We likewise agree with the Examiner that independent claims 1
and 19 do not require that EEG data be used for diagnosis of a
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Application 12/744,549
pathophysiological condition. As the Examiner observes, "[t]here is no
explicit step of diagnosing a pathophysiological condition in the claims.
Corresponding to a pathophysiological condition is not the same as having a
pathophysiological condition." (Ans. 5---6.) Furthermore, contrary to
Appellants' position that Suffin teaches away from a system in which EEG
data is used for diagnosis, we agree with the Examiner that Suffin teaches
that a subject is diagnosed with a neurological condition (id. at 5, 7; see, e.g.,
FF 2 ("quantitative neurophysiologic information, preferably including
quantitative electrophysiologic information, is a reliable indicator by which
to choose therapies for individuals with behaviorally-diagnosed psychiatric
conditions and to predict outcomes from selected therapies"); FF 3 ("this
invention provides a method and system for improving the likelihood of
selecting an effective treatment the first time")).
Regarding independent claim 20, which recites, inter alia, selecting
"a therapeutic agent based on a comparison of the subject to a plurality of
individuals who responded favorably to the therapeutic agent, wherein the
individuals include at least one having data features similar to those of the
baseline profile and diagnosed with a neurological disorder diagnosed for
the subject" (emphasis added), we agree with the Examiner that Suffin
teaches this claim element (Ans. 7). In particular, as the Examiner observes,
section [0051] of Suffin teaches that the subject is diagnosed with
a behaviorally-diagnosed psychiatric condition (a neurological
disorder). Section [0053] states that a preceding traditional
diagnosis of a mental disorder (a neurological condition) is
capable of being used with the method and apparatus of Suffin.
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Application 12/744,549
Finally, section [0056] discloses that the plurality of individuals
to which the subject are compared are also diagnosed with a
neurological disorder.
(Ans. 7; FF 2--4.)
We also agree with the Examiner that Suffin teaches that a Z-score is
a unit of probability, which is used to determine whether a patient is in a
normal group or a symptomatic group, and thereby determine whether a
baseline profile corresponds to one of two predetermined pathophysiological
conditions (Ans. 6-7; FF 5-7). Therefore, we are not persuaded by
Appellants' contention that the computation of a Z-score in relation to
Suffin's EEG data is not necessarily correlative with an associated disorder
or a diagnosis.
SUMMARY
We affirm the rejection of claims 1, 9, and 20 under 35 U.S.C.
§ 102(b) based on Suffin. Claims 2-8 fall with claim 1, claims 10-19 fall
with claim 9, and claims 22 and 23 fall with claim 21.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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