Ex Parte Thukral et al

Patent Trial and Appeal Board

Jan 27, 2014

12119143 (P.T.A.B. Jan. 27, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte AJAY THUKRAL, PAUL GALLEY, SIVA CHITTAJALLU,
and STEFAN WEINERT1
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Appeal 2012-004388
Application 12/119,143
Technology Center 1600
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Before ERICA A. FRANKLIN, ULRIKE W. JENKS, and
TINA E. HULSE, Administrative Patent Judges.

HULSE, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims relating to
chronic disease management. The Examiner rejected all claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

1 Appellants identify the Real Party in Interest as Roche Diagnostics
Operations, Inc. (App. Br. 1.)
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STATEMENT OF THE CASE
The claimed invention relates to “a computerized system for
developing patient specific therapies for chronic disease management based
on dynamic modeling of patient physiology.” (Spec. ¶ 2.) In general, the
claimed system “helps analyze treatment and managing of diseases . . .
which are chronic in nature by analyzing human physiology and metabolic
activity of an individual in a dynamic system, and enabling a user to define
protocol, analyze collected data, fine tune therapy requirements, and provide
patient-specific diagnosis, therapy advice, and prognosis.” (Spec. ¶ 49.)
Claims 1-10 and 12-25 are on appeal. (App. Br. 2.)
Claim 1 is representative and is reproduced below:
l. A computerized system used by a user(s) to developing
patient specific therapies for chronic disease management of a
patient(s) having a known disease, the system comprising:
a server computer having a processor and a database; and
a client computer operably connected to the server
computer, the client computer having a monitor, memory, and
an input device operably connected to a processor, and wherein
the processor of at least one of the server computer and the
client computer is running:
a data collection module which enables the system to
collect patient specific data according to a data collection
protocol selected from multiple different data collection
protocols provided in at least one of the memory of the client
computer and the database of the server computer, and performs
integrity and quality checks on the patient specific data to
ensure that the collection of the patient specific data has been
according to the data collection protocol, each of the different
data collection protocols being specialized to identify or
determine a particular aspect of the known disease of the
patient;
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a user interface which enables the user to select a patient
model from a plurality of patient models provided by the
system;
a model validation module which enables the system to
validate the selected patient model to determine at least one of
how well the patient model simulates the known disease and
how well the patient model simulates reaction of the known
disease to prescribed therapy, over varying operating ranges or
conditions or both;
an analyses module which enables the system to apply
the patient specific data to the selected patient model to extract
useful patient specific physiological information, and to use the
extracted patient specific physiological information to develop
one or more patient specific therapies for treating the chronic
disease of the patient;
a result validation and presentation module which
enables the system to validate the one or more patient specific
therapies and to present validated ones of the one or more
patient specific therapies on the user interface for approval.

The claims stand rejected as unpatentable under 35 U.S.C. § 103(a)
over Bangs2 and Hennessy.3 (Ans. 4-10.)
DISCUSSION
The Examiner rejected each of the claims under 35 U.S.C. § 103.
Thus, the sole issue we consider is whether the preponderance of the
evidence supports the Examiner’s conclusion that the claims are
unpatentable as obvious over Bangs and Hennessy.

2 Bangs et al., US 2005/0131663 A1, published June 16, 2005.
3 Hennessy et al., US 6,277,071 B1, issued August 21, 2001.
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Analysis
The Examiner found that Bangs teaches each of the limitations of
claim 1, except for a data collection module that performs integrity and
validity checks on patient data or a system that can be used specifically for
management of chronic diseases. (Id. at 5.) The Examiner found that
Hennessy teaches these limitations, and found that it would have been
obvious to combine the data validation software module of Hennessy with
the therapy-simulation software modules of Bangs, because both inventions
are directed to “analysis of medical data on a per-patient basis, so one of
ordinary skill in the art would have readily predicted that the combination
would successfully result in a system that manages a disease in a patient-
specific manner using specific data-collection protocols.” (Id. at 7.)
In response, Appellants assert that the prior art references do not teach
or suggest certain limitations of the claims and that the Examiner has
therefore failed to establish a prima facie case of obviousness for each of the
claims. Appellants’ arguments have been carefully considered, but are not
found to be convincing. We address each of the arguments in turn below.
“data collection protocol . . .”
Appellants argue that the combination of Bangs and Hennessy does
not teach “data collection protocols [that are] specialized to identify or
determine a particular aspect of the known disease of the patient,” which
appears in each of the claims on appeal. (App. Br. 15) (emphasis omitted.)
Appellants assert that Bangs is limited to “first assessing which diseases may
be relevant to the patient” and does not disclose simulating potential
therapies for a known disease, as required by the claims. (Id.)
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We do not find Appellants’ argument persuasive. As the Examiner
noted (Ans. 11), in addition to providing a diagnosis, Bangs teaches that
“[b]ased on the results of the set of tests, the clinical decision support system
can then provide to a doctor a . . . prognosis for the subject.” (Bangs ¶ 51.)
Providing a prognosis for a patient suggests that the disease for which the
prognosis is given is presumably known. We also agree with the Examiner
that Hennessy teaches a data collection protocol that is specialized to
identify a particular aspect of a known disease. (See Ans. 11-12.)
Specifically, Hennessy discloses collecting data to monitor a patient with
diabetes, including test data such as blood glucose levels and lipid profiles.
(See Hennessy at 6:6-36.)
Thus, we find that the preponderance of the evidence of record
supports the Examiner’s findings that Bangs and Hennessy teach a data
collection protocol “specialized to identify or determine a particular aspect
of the known disease of the patient.”
“a user interface which enables the user to select a patient model”
Appellants assert that the prior art does not teach “a user interface
which enables the user to select a patient model.” (App. Br. 15.) In
particular, Appellants argue that Bangs teaches that the virtual patient or
patient model is selected by subsystem 120 of the system 100, and not the
user. (Id. at 15-16.)
We disagree with Appellants’ characterization of Bangs. As the
Examiner noted (Ans. 12), Bangs teaches a system with a user interface “[t]o
provide for interaction with a user.” (See Bangs ¶ 154.) Moreover, Bangs
teaches that “[i]t is contemplated that a medical practitioner can manually
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input processing options to associate a subject with a virtual patient or to
confirm results of an automated association between the subject and the
virtual patient.” (Bangs ¶ 66.) That is, through the user interface, the doctor
can manually select a virtual patient, or a “patient model,” according to the
claims. Thus, we find that the preponderance of the evidence of record
supports the Examiner’s findings that Bangs teaches “a user interface which
enables the user to select a patient model.”
“defining at least a type of patient-specific data to be collected and a manner
in which the patient-specific data is to be collected”
Independent claim 12 is similar to claim 1, but further recites that the
data collection protocols “defin[e] at least a type of patient-specific data to
be collected and a manner in which the patient-specific data is to be
collected.” (Claim 12.) Appellants assert that because the Examiner failed
to address this limitation explicitly in the Final Rejection, the Examiner
failed to establish a prima facie case of obviousness for this claim. (App. Br.
16-17.) In response, the Examiner noted that a “protocol” inherently defines
a specific manner in which data must be collected. (Ans. 12.) Moreover,
the Examiner found that Bangs teaches that subjects are monitored over
time, “which constitutes a defined manner in which data are collected.” (Id.)
We find that the preponderance of the evidence supports the
Examiner’s findings. In the Final Rejection, the Examiner stated that
“Claim 12 is directed to a system similar to that of claim 1.” (Id. at 8.) With
respect to claim 1, the Examiner found that Hennessy discloses:
[A] software module for receiving entry of patient records in a
defined format (i.e. ‘according to a data collection protocol’;
6:17-29), for receiving data related to the patient record from
various medical tests intended to monitor the patient’s disease
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(6:30-51 and 9:31-32), and for verifying and processing the test
data using a test-specific data collection protocol (9:32-63).
(Id. at 6.) That is, Hennessy teaches a data collection protocol where the
user enters data for a specific test type into the system, such as blood
glucose, and the system then updates the “planned events data . . . based on
the criteria for the quality plan.” (Hennessy at 6:30-36; 9:31-63.) For
example, the system will automatically schedule a test if there is a
predetermined frequency for taking the test. (Id. at 9:55-57.) We therefore
find that Hennessy teaches a data collection protocol that defines a type of
patient-specific data to be collected (e.g., blood glucose) and the manner in
which the data is to be collected (e.g., frequency).
Thus, we find that the preponderance of the evidence supports the
Examiner’s conclusion that this limitation of claim 12 would have been
obvious in view of Bangs and Hennessy.
“relevance rating”
Appellants argue that the prior art fails to teach claim 25’s “data
collections protocols module which . . . provides to the user for selection
therapy assessments/recommendations each with a relevance rating that is
based on the integrity and quality of the collected patient specific data.”
(Claim 25.) Specifically, Appellants assert that the prior art does not
disclose or suggest the “relevance rating” of the claim. (App. Br. 17-18;
Reply Br. 2-3.) The Examiner found that the “knowledge gap” taught in
Bangs constituted a “relevance rating” of the claim. (Ans. 12-13.)
We agree with Appellants. According to the Specification, a
“relevance rating is provided next to each therapy assessment/
recommendation that is based on the effect selection of such a therapy
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assessment/recommendation based on the collected data quality will have on
generating changes to the patient’s therapy.” (Spec. ¶ 113.) That is, the
relevance rating determines how effective the recommended treatment will
be based on the data collected about a patient. The “knowledge gap” of
Bangs, however, is different. According to Bangs, the “knowledge gap”
refers to the probability of a virtual patient being associated with a particular
subject. (Bangs ¶ 122.) This teaching is unrelated to predicting the efficacy
of a recommended treatment. Accordingly, we conclude that the
preponderance of the evidence does not support the Examiner’s conclusion
that claim 25 is obvious over Bangs and Hennessy, and we reverse as to this
claim alone.
Conclusions of Law
The preponderance of the evidence supports the Examiner’s
conclusion that claims 1 and 12 are unpatentable as obvious over Bangs and
Hennessy. Because Appellants did not separately argue the patentability of
claims 2-10 and 13-24, these claims fall with claims 1 and 12. 37 C.F.R. §
41.37(c)(1)(vii).
The preponderance of the evidence does not support the Examiner’s
conclusion that claim 25 is unpatentable as obvious over Bangs and
Hennessy.

SUMMARY
We affirm the rejections of claims 1-10 and 12-24, but we reverse the
rejection of claim 25 under § 103.

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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).

AFFIRMED-IN-PART

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