Ex Parte Yao

Patent Trial and Appeal Board

Feb 23, 2017

13160245 (P.T.A.B. Feb. 23, 2017)

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.
13/160,245 06/14/2011 Mylene Yao 6000-0001US 2981
91029 7590
CANAANLAW, P.C.
PO Box 1860
Los Gatos, CA 95031-1860
EXAMINER
PAULSON, SHEETAL R.
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
02/27/2017 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):
karen@canaanlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MYLENE YAO
Appeal 2014-0085771
Application 13/160,2452
Technology Center 3600
Before BIBHU R. MOHANTY, JAMES A. WORTH, and
TARA L. HUTCHINGS, Administrative Patent Judges.
HUTCHINGS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1—21, 24—28, 35, 36, and 39-44. We have jurisdiction
under 35 U.S.C. § 6(b).
1 Our decision references Appellant’s Appeal Brief (“Appeal Br.,” filed
Apr. 6, 2014) and Reply Brief (“Reply Br.,” filed Aug. 6, 2014), and the
Examiner’s Answer (“Ans.,” mailed June 6, 2014), Advisory Action (“Adv.
Act., mailed Dec. 31, 2013), and Final Office Action (“Final Act.,” mailed
Nov. 7, 2013).
2 Appellant identifies UNIVFY, Inc. as the real party in interest. Appeal
Br. 3.
Appeal 2014-008577
Application 13/160,245
We AFFIRM.
CLAIMED INVENTION
Appellant’s claimed invention “relates generally to the delivery of
decision support system (DSSs) and electronic health records (EHRs).”
Spec. 12.
Claims 1 and 39 are the independent claims on appeal. Claims 1 and
39, reproduced below, are illustrative:
1. A method comprising the steps of:
(a) establishing an electronic decision support system
(DSS) comprising a prediction model, wherein the DSS is
integrated with an electronic health record (EHR), wherein the
EHR is specific for fertility treatments and the DSS provides a
personalized prediction of a probability of a live birth event; and
(b) delivering the DSS to an individual or healthcare
provider, wherein the prediction model is developed and
validated based upon clinic-specific, region-specific, and/or
population-specific variables.
39. A system comprising:
(a) an electronic health care (EHR) platform by way of an
internet connection, wherein a user enters information into the
EHR platform;
(b) an application server (AP) that communicates with the
computer terminal, wherein the AP comprises customized
algorithms, wherein the algorithms are used to interpret the
information entered into the EHR platform and provide a
prediction model for a health condition or disease state; and
(c) a database server (DP) that communicates with the AP,
wherein the DB stores the information entered on the EHR
platform and provides encryption to keep the information secure,
wherein the customized algorithm provides a prediction
model based upon the information provided by the user in the
EHR, and
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Application 13/160,245
wherein the information provided by the user in the EHR
is specific for fertility treatments and the DSS provides a
personalized prediction of a probability of a live birth event.
REJECTION
Claims 1—21, 24—28, 35, 36, and 39-44 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Rabinowitz (US 2006/0052945 Al, Mar. 9,
2006) and Williams (US 2007/0082329 Al, pub. Apr. 12, 2007).
ANALYSIS
Independent Claim 1 and Dependent Claims 2—21, 24—28, 35, and 36
We are not persuaded by Appellant’s argument that the Examiner
erred in rejecting claim 1 under § 103(a) because Rabinowitz fails to
disclose or suggest a decision support system (DSS) integrated with an
electronic health record (EHR), as recited in claim 1, limitation (a). Appeal
Br. 7—8. Instead, we agree with, and adopt, the Examiner’s findings as set
forth in the response to Appellant’s argument at pages 8—9 of the Answer.
See Ans. 8 (citing Rabinowitz || 27—28); see also id. at 2 (citing
Rabinowitz, || 27—28).
Appellant argues that Rabinowitz teaches a DSS “populated with a
large amount of information from multiple sources,” not an EHR from a
patient that is integrated into the Rabinowitz system to generate the
prediction model. Here, Appellant’s Specification describes that the term
EHR refers to both electronic personal health records (EPHR) and electronic
medical records (EMR). Spec. 127. EPHR refers to health information
provided in response to a questionnaire, and EMR refers to medical records
that are generated by a health care provider, clinic, hospital, and/or
laboratory. Id.
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Application 13/160,245
Rabinowitz at Figure 1 and paragraphs 27—28 and 35 describes
integrating patient profile information 112, patient symptomatic information
113, and patient preferences 114, patient diagnostic information, genetic
data 114, and patient treatment information 115 into a standardized data
model. We find that patient profile information, patient symptomatic
information, and patient preferences, as described by Rabinowitz, are
examples of health information provided by a patient in response to verbal
or written questions and/or forms, akin to an EPHR. We further find that
patient diagnostic information and treatment information, as described by
Rabinowitz, are medical records akin to an EMR. See Reply Br. 4
(acknowledging that Rabinowitz teaches the use of EMR data to populate
the model). The Examiner finds, and we agree, that integrating EPHR and
EMR data into a standardized data model, as described by Rabinowitz,
constitutes a DSS integrated with an EHR, as required by claim 1, under the
broadest, reasonable interpretation standard.
We are not persuaded by Appellant’s argument that the Examiner
erred in rejecting claim 1 under 35 U.S.C. § 103(a) because Rabinowitz does
not describe or suggest that “the prediction model is developed and validated
based upon clinic-specific, region-specific, and/or population-specific
variables,” as recited in claim 1, limitation (b). Appeal Br. 8—10. Instead,
we agree with, and adopt, the Examiner’s findings as set forth in the
response to Appellant’s argument at page 9 of the Answer. See Ans. 9
(citing Rabinowitz, || 48, 53—55); see also id. 12 (citing Rabinowitz, || 53—
55).
Appellant acknowledges that Rabinowitz at paragraph 48 and Figures
1, 4, and 8 describes a patient subgroup having similar characteristics in
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Application 13/160,245
categories such as: profile information, patient preferences, treatment
information and diagnostic information, including genetic data. Reply Br. 6.
But Appellant contends that such characteristics are not clinic-specific,
region-specific, and/or population-specific, as required by claim 1. Id.
Here, however, the Specification describes selecting “clinic-specific,
region-specific, and/or population-specific variables” from a group
consisting of “demographic variables, clinical variables, laboratory
variables, or combinations thereof.” Spec. 110. Laboratory variables
include test results of body fluids, tissue level data, imaging results, and
biomarker test results. Id. Accordingly, we agree with the Examiner that
diagnostic information, as described by Rabinowitz, constitutes “clinic-
specific, region-specific, and/or population-specific variables,” as required
by claim 1, under the broadest, reasonable interpretation standard.
We are not persuaded by Appellant’s argument that the Examiner
erred in rejecting claim 1 under 35 U.S.C. § 103(a) because Williams
provides a diagnostic model instead of a prediction model and does not
determine the outcome of a live birth event. Appeal Br. 14—18. In rejecting
claim 1 under 35 U.S.C. § 103(a), the Examiner acknowledges that
Rabinowitz does not explicitly teach wherein the EHR is specific for fertility
and the DSS provides a personalized prediction of a probability of a live
birth event. Final Act. 3. However, the Examiner finds that Williams
teaches fertility treatments, and Rabinowitz teaches prediction models. Adv.
Act. 2. And the Examiner determines that it would have been obvious to
modify Rabinowitz’s EHR, to focus on fertility, as disclosed by Williams,
and predict the outcome of the treatment (i.e., the probability of a live birth).
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See Ans. 11—12. Appellant’s arguments against the references individually
is not persuasive where the rejection is made over the combination.
In view of the foregoing, we sustain the rejection of claim 1. We also
sustain the rejection of dependent claims 2—21, 24—28, 35, and 36, which are
not separately argued.
Independent Claim 39 and Dependent Claims 40—44
We are not persuaded by Appellant’s argument that the Examiner
erred in rejecting claim 39 under 35 U.S.C. § 103(a) because Rabinowitz
does not include a step where the user enters information into an EHR
platform, as recited in claim 39, limitation (a). Appeal Br. 12. Specifically,
Appellant argues that the user interface described with reference to Figures
1, 4, and 8 at paragraphs 56, 206, and 286 of Rabinowitz “is not a computer
terminal where a patient enters medical information,” and “[njowhere in
Rabinowitz et al. is a step described where the patient enters relevant
information.” Id.', see also Reply Br. 6 (“Rabinowitz et al. do not describe
the user taught therein as entering patient information directly into the
DAME database.”)
Appellant’s argument is not persuasive, at least because claim 39
recites that a user, not a patient, enters information, and claim 39 does not
specify how the user enters medical information into the platform. See Spec.
116 (“[t]he EHR [platform] may comprise an internet platform that supports
entry of personal health data of an individual, wherein the personal health
data may be entered into the EHR platform by the individual, a physician, a
healthcare provider, or a clinic administrator, each of which may
individually designate sharing privileges for the EHR, wherein the sharing
privileges may be tailored to specify time limits for sharing.”)
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The Examiner finds that Rabinowitz’s description of data acquisition
beginning with data feeders through a network constitutes a user entering
information into an EHR platform under a broad but reasonable
interpretation of the claim language. Ans. 10. And Appellant’s arguments
in light of the claim language do not apprise us of error.
We are not persuaded by Appellant’s argument that the Examiner
erred in rejecting claim 39 under 35 U.S.C. § 103(a) because Rabinowitz
does not describe or suggest customized algorithms based on information
entered by users in an EHR, as recited in claim 39, limitation (b). Appeal
Br. 12. Appellant disputes the EHR aspect of limitation (b). Id. But we
find this argument unpersuasive for the reasons set forth above with respect
to claim 1. As correctly noted by Appellant, Rabinowitz describes at
paragraph 48 three statistical models. See Appeal Br. 12. Each statistical
model specifies a patient subgroup so that data from a particular patient can
be evaluated against all other patients in the subgroup, thereby constituting
the claimed customized algorithm used to interpret the information entered
into the EHR platform, as recited in claim 39, under the broadest reasonable
interpretation standard.
We are not persuaded by Appellant’s argument that the Examiner
erred in rejecting claim 39 under 35 U.S.C. § 103(a) because Rabinowitz
does not describe or suggest a database server (DP) that communicates with
the AP, wherein the DB stores the information entered on the EHR platform
and provides encryption to keep the information secure, as recited in claim
39, limitation (c). Appeal Br. 13. Instead, we agree with the Examiner’s
findings that Rabinowitz at paragraph 57 discloses the argued limitation.
Final Act. 8. Appellants argue, in particular, that Rabinowitz does not
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describe the “EHR aspect of step (c) of claim 39.” Appeal Br. 13. We find
this argument regarding the EHR unpersuasive for similar reasons described
with respect to claim 1.
Appellant argues that the Examiner erred in rejecting claim 39 under
35 U.S.C. § 103(a) because Williams does not cure the deficiencies of
Rabinowitz. Appeal Br. 13. We are not persuaded by this argument for the
same reasons set forth with respect to claim 1.
Therefore, we sustain the Examiner’s rejection of claim 39 under
35 U.S.C. § 103(a). We also sustain the rejection of dependent claims 40-
44, which are not separately argued.
DECISION
The Examiner’s rejection of claims 1—21, 24—28, 35, 36, and 39-44
under 35 U.S.C. § 103(a) is affirmed.
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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