Ex Parte Fogel

Patent Trial and Appeal Board

Mar 5, 2019

14974236 (P.T.A.B. Mar. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/974,236 12/18/2015
24280 7590 03/07/2019
CHOATE, HALL & STEWARTLLP
TWO INTERNATIONAL PLACE
BOSTON, MA 02110
FIRST NAMED INVENTOR
Barry Fogel
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.
0422022-0013 5599
EXAMINER
REICHERT, RACHELLE LEIGH
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
03/07/2019 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):
patentdocket@choate.com
jnease@choate.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BARRY FOGEL
Appeal 2018-001628
Application 14/974,236
Technology Center 3600
Before ELENI MANTIS MERCADER, NORMAN H. BEAMER,
and ADAM J. PYONIN, Administrative Patent Judges.
MANTIS MERCADER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner's
final rejection of claims 1, 10, 11, and 13-29, which constitute all the
pending claims in this application. 2 We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
1 Appellant identifies PointRight, Inc. as the real party in interest (App. Br.
2).
2 We note that current dependent claim 10 is dependent on canceled claim
9; should there be further prosecution, the Examiner may wish to review the
claim dependencies for compliance.
Appeal 2018-001628
Application 14/974,236
THE INVENTION
Appellant's claimed invention is directed to "providing personalized
prognostic profiles" including a "personalized prognostic graph showing the
historical outcomes of a matched population that is a subset of a reference
population over a display interval" (Abstract).
Independent claim 1, reproduced below, is representative of the
subject matter on appeal:
1. A system for providing personalized prognostic profiles,
compnsmg:
at least one memory operable to store a reference
database associated with a plurality of individuals, the reference
database comprising a combination of time-independent and
time-dependent data items associated with each of the plurality
of individuals;
a processor communicatively coupled to the at least one
memory, the processor being operable to:
receive, over a network, from a client computing device,
time-independent and time-dependent data items associated
with an index patient,
wherein each time-dependent data item ( 1) associated
with the index patient, and (2) in the reference database is
linked to a corresponding time point or time interval;
receive, over the network, from a client computing
device, a first request to generate a personalized prognostic
profile corresponding to the index patient, the first request
compnsmg:
(1) a binary clinical outcome of interest;
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Application 14/974,236
(2) a display interval indicating the time interval that will
be covered by the personalized prognostic profile;
(3) either (a) two or more time intervals or time points of
interest that differ from each other and are each no greater than
or are within the display interval, or (b) one or more time
intervals or time points of interest and a treatment of interest,
and
( 4) forced match variables, wherein the forced match
variables comprise one or more clinical or demographic items
used to define a proper subset of the plurality of individuals, by
requiring that every person in the subset match the index patient
based on the forced match variables,
wherein, if there are two or more time intervals of
interest, each of the plurality of time intervals of interest is
associated with a corresponding priority level with respect to
the other time intervals; and
generate a personalized prognostic profile corresponding
to the index patient, the personalized prognostic profile
comprising: a personalized prognostic graph showing the
historical outcomes of a matched population that is a subset of
the plurality of individuals over the display interval, a
necessarily included widget containing identifying information
about the index patient, indicating the forced match variables,
the time interval( s) of interest, and the treatment of interest if
applicable, contextual data associated with one or more of the
index patient and the personalized prognostic graph, and one or
more supplemental widgets providing further information
concerning the index patient's clinical status, care received,
care plans, care preferences, or issues related to illness-related
clinical or personal concerns of the index patient, wherein:
( 1) the matched population is a subset of the plurality of
individuals in which every person matches the index patient on
the forced match variables and on a further property that an
estimated probability of occurrence of the outcome of interest
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Application 14/974,236
during one or more user-specified time intervals following a
starting point is within a preset interval of the estimated
probability of occurrence of the outcome of interest for the
index patient during that interval,
wherein predictions are made using predictive models
developed on a subset of the matched population that matches
the index patient on the forced match variables, and
wherein the starting point is a point in which there are
valid values in the reference database for all of the forced match
variables and known or imputable values of all variables used
in the predictive models; and
wherein the matched population is selected employing an
iterative process in which the predictive model at each step is
generated, validated, and applied to subsets of the subset of the
plurality of individuals created at the previous step, culminating
in the selection of the matched population in which each
member matches the index patient on the forced match
variables and each member's estimated probability in each of
two or more predictive models falls within a specified interval
of the estimated probability for the index patient;
(2) the personalized prognostic graph shows actual
outcomes over the display interval after a starting point for all
members of the matched population; and
(3) the necessarily included widget comprises sufficient
information for users to know facets of the prognostic profile
that were personalized; and
( 4) the one or more supplemental widgets comprise
checklists of issues for consideration.
Corrected App. Br. 3-5 (Corrected Claims Appendix).
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Application 14/974,236
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is the following:
Langhei er
Heywood
US 2006/0173663 Al Aug. 3, 2006
US 2009/0125333 Al May 14, 2009
REJECTIONS
The Examiner made the following rejections3:
Claims 1, 10, 11, and 13-29 stand rejected under 35 U.S.C. § 101
because the claimed invention is directed to a judicial exception (i.e., a law
of nature, a natural phenomenon, or an abstract idea) without significantly
more. Final Act. 3.
Claims 1, 10, 11, and 13-29 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Heywood and Langheier. Final Act. 8.
ISSUES
The issues are whether the Examiner erred in finding:
1. the claimed invention to be directed to a judicial exception without
significantly more; and
3 The rejection of claims 2-9 and 12 under 35 U.S.C. § 112(a) is now moot,
as claims 2-9 and 12 were canceled in an After-Final Amendment entered
on April 18, 2017. See Final Act. 6; Adv. Act. 1. Similarly, the rejection of
claims 1-15 and 17-29 under 35 U.S.C. § 112(b) is now moot, as
amendments to correct the identified errors were made to claim 1 and claim
17 in an After-Final Amendment entered on April 18, 2017. See Final Act.
7; Adv. Act. 1.
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Application 14/974,236
2. the combination of Heywood and Langheier teaches or suggests the
limitation of
wherein the matched population is selected employing an
iterative process in which the predictive model at each
step is generated, validated, and applied to subsets of the
subset of the plurality of individuals created at the
previous step, culminating in the selection of the matched
population in which each member matches the index
patient on the forced match variables and each member's
estimated probability in each of two or more predictive
models falls within a specified interval of the estimated
probability for the index patient,
as recited in independent claim 1 ( emphasis added), and similarly
recited in independent claim 16.
ANALYSIS
Except where indicated, we adopt the Examiner's findings in the
Answer and Final Office Action and we add the following primarily for
emphasis. We note that if Appellant failed to present arguments on a
particular rejection, we will not unilaterally review those uncontested
aspects of the rejection. See Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI
2010) (precedential); Hyatt v. Dudas, 551 F.3d 1307, 1313-14 (Fed. Cir.
2008) (the Board may treat arguments Appellant failed to make for a given
ground of rejection as waived).
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Application 14/974,236
Patent Eligibility
The Examiner determines the claims are patent ineligible under
35 U.S.C. § 101, because
[t]he abstract idea identified here is receiving patient data of an
index patient and a population of patients and generating a
personalized prognostic profile for an index patient using
predictive models developed from analyzing patient data from
the population
(Ans. 4). The Examiner further finds that "generic computer hardware"
performs "routine and conventional functions" and "Appellant's invention is
merely using the computer as a tool to carry out the claimed steps" (Ans. 6;
see also Alice Corp. Pty. Ltd. v. CLS Banklnt'l, 573 U.S. 208,217 (2014)
( describing the two-step framework "for distinguishing patents that claim
laws of nature, natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts")).
After the mailing of the Answer and the filing of the Brief in this case,
the US PTO published revised guidance on the application of§ 101 (2019
Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7,
2019) (hereinafter "Memorandum")). Under the Memorandum, the Office
first looks to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas
(i.e., mathematical concepts, certain methods of 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)).
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Application 14/974,236
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, does the Office then look to whether
the claim:
(3) adds a specific limitation beyond the judicial exception that are not
"well-understood, routine, conventional" in the field (see MPEP
§ 2106.0S(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 Memorandum.
We agree with the Examiner that the claim is directed to an abstract
idea, and we find that claim 1 recites both mathematical concepts and
organizing human activity. Claim 1 recites use of "predictive models" and
"each member's estimated probability in each of two or more predictive
models falls within a specified interval of the estimated probability for the
index patient," which in the context of determining a prognostic profile,
indicates these models typically estimate the probability that a patient will
still be alive at some point in the future, and are estimated using
mathematical tools. See Spec. ,r,r 127-145. Accordingly, claim 1 is directed
to an abstract idea involving mathematical concepts.
Claim 1 is further directed to organizing human activity and in
particular managing a relationship between a doctor and a patient, as the
"personalized prognostic profile" generated for a patient serves as a
diagnostic tool often used to decide a future treatment regimen for the
patient. "An accurate prognosis is the foundation of a rational discussion of
advance care plans, including decisions to forgo certain treatments" (Spec.
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,r 2). Additionally, claim 1 requires the "personalized prognostic profile" to
include "one or more supplemental widgets [that] comprise checklists of
issues for consideration." These elements of the claim directly relate to
organizing human activity, involving medical personnel and especially the
patient.
If the claim is "directed to" an abstract idea, we tum 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 (quoting Mayo Collaborative
Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72-73, 79 (2012)). "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. (alterations in original) (quoting Mayo, 566 U.S. at 77).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
Appellant contends that relevant data is "presented to the patient in an
interactive graphical interface to aid in making clinical decisions such as
whether to opt for palliative end-of-life care, or to undergo a specific
treatment" (Reply Br. 4) and that "[t]he nested, iterative process described in
the present claims enable a user to obtain predictions that are truly
meaningful to the patient" (Reply Br. 6).
We agree with Appellant, as the combination of the claimed:
1. "iterative process in which the predictive model at each step is
generated, validated, and applied to subsets of the subset of the
plurality of individuals created at the previous step,"
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Application 14/974,236
2. "estimated probability of occurrence of the outcome of interest," and
3. "personalized prognostic graph show[ing] actual outcomes over the
display interval after a starting point for all members of the matched
population,"
is integrated together into a practical application to provide useful and
potentially life-saving information allowing a physician "to communicate a
credible prognosis to patients, families and other stakeholders" (Spec. ,r 2).
See Memorandum, Step 2A, Prong Two.
There are no additional elements that need to be considered under
Step 2B.
Accordingly, we reverse the Examiner's rejection of claims 1, 10, 11,
and 13-29 under 35 U.S.C. § 101.
Obviousness
Appellant argues that "[ n ]either Heywood nor Langheier, alone or in
combination, describes a personalized prognostic survival graph that derives
its input, inter alia, from an iterative 'nested' approach of selecting a
matched population" (App. Br. 24). Particularly, Appellant contends that
"Heywood does not mention iterative or nested approaches, but focuses, e.g.,
on (forced) matching of an index patient to a single population, e.g., by
employing fuzzy logic" (App. Br. 24), and that
Langheier mentions an iterative concept, but this concept is
directed to improving a model for a given outcome within a
specified search space, not on modeling additional outcomes
within a search space defined by a combination of forced
matches and results of previous models of different binary
outcomes
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(App. Br. 25). Appellant further contends that "a person of ordinary skill
would not look to Langheier to modify the methods in Heywood and would
not be motivated to combine the references" (App. Br. 25), because
Langheier is about building a robust, accurate, and highly
generalizable model, rather than a valid, personally-relatable
model of an outcome especially meaningful for the patient
and/or to a specific user, that is tailored to an individual and
essentially single use
(Reply Br. 8).
The Examiner finds, and we agree, that Langheier "discusses the
iterative population matching steps found in the instant claims" (Ans. 11
(quoting Langheier ,r 112 and Fig 6); see Ans. 9-10). The Examiner
additionally finds, and we agree, that "[b ]oth Langheier and Heywood are
directed towards using data to determine an outcome for a patient, with
Langheier being used to teach the specifics on the predictive modeling"
(Ans. 11).
Appellant argues the references separately and does not consider
application of Heywood's dataset (which, as Applicant admits, is "matching
of an index patient to a single population defined by diagnoses and
demographics" (Reply Br. 8 ( emphasis omitted))) as the input for application
of Langheier's "hierarchy of predictive models" (Langheier ,r 112). Further,
while Appellant refers to Heywood's dataset as a "single population,"
Appellant provides no factual evidence or reasoning to distinguish
Heywood's "community of patients" having "matching profiles" (see
Heywood ,r 51 ( describing matching profiles of Multiple Sclerosis patients
matching a particular profile)) from the claimed "proper subset of the
plurality of individuals."
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We agree with the Examiner that both Langheier and Heywood are
directed towards using data to determine an outcome for a patient, and we
are not persuaded by Appellant's argument that one skilled in the art "would
not be motivated to combine the references," as Appellant fails to challenge
the Examiner's finding that Langheier supplies motivation by allowing "for
missing values to be considered as an additional category" (Ans. 11; see also
Final Act. 14 (citing Langheier ,r 44)). Further, Appellant's
characterizations of the invention as a "personally-relatable model" and
"single use" are not commensurate with the scope of the claim.
Accordingly, we sustain the rejection of independent claim 1, and
independent claim 16 commensurate in scope, as well as independent claim
17 and dependent claims 10, 11, 13-15, and 18-29 not argued separately. 4
See App. Br. 24--26.
CONCLUSION
The Examiner erred in finding:
1. the claimed invention to be directed to a judicial exception without
significantly more.
The Examiner did not err in finding:
2. the combination of Heywood and Langheier teaches or suggests the
limitation of
4 We note that independent claim 1 7 is not commensurate in scope to
independent claims 1 and 16 because independent claim 1 7 contains no
limitation corresponding to "wherein the matched population is selected
employing an iterative process" as appearing in independent claims 1 and
16.
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Application 14/974,236
wherein the matched population is selected employing an
iterative process in which the predictive model at each
step is generated, validated, and applied to subsets of the
subset of the plurality of individuals created at the
previous step, culminating in the selection of the matched
population in which each member matches the index
patient on the forced match variables and each member's
estimated probability in each of two or more predictive
models falls within a specified interval of the estimated
probability for the index patient,
as recited in independent claim 1 ( emphasis added), and similarly
recited in independent claim 16.
DECISION
The Examiner's decision rejecting claims 1, 10, 11, and 13-29 under
35 U.S.C. § 101 is reversed.
The Examiner's decision rejecting claims 1, 10, 11, and 13-29 under
35 U.S.C. § 103 is affirmed.
The Examiner's decision is affirmed because we have affirmed at
least one ground of rejection with respect to each claim on appeal. See 37
C.F.R. § 4I.50(a)(l).
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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