Ex Parte Kovatchev et al

Patent Trial and Appeal Board

Jul 11, 2016

12664444 (P.T.A.B. Jul. 11, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/664,444 12/14/2009
134006 7590 07113/2016
V orys, Sater, Seymour and Pease LLP (UV A)
1909 K St., NW
Ninth Floor
Washington, DC 20006
FIRST NAMED INVENTOR
Boris P. Kovatchev
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.
070239.000004 2315
EXAMINER
RIGGS II, LARRY D
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
07/13/2016 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):
vmdeluca@vorys.com
patlaw@vorys.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BORIS P. KOVATCHEV, MARC D. BRETON,
CLAUDIO COBELL!, and CHIARA DALLA MAN 1
Appeal2014-001168
Application 12/664,444
Technology Center 1600
Before ERIC B. GRIMES, TINA E. HULSE, and RICHARD J. SMITH,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
to test monitoring or treatment strategies for diabetes, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
"In September 2006 the Juvenile Diabetes Research Foundation
(JDRF) initiated the Artificial Pancreas Project," which combines
1 Appellants identify the Real Party in Interest as University of Virginia
Patent Foundation. (Appeal Br. 1.)
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Application 12/664,444
continuous glucose monitoring and an insulin infusion pump. (Spec. 1 :26-
31.) The Specification states that "[t]he future development of the artificial
pancreas will be greatly accelerated by employing mathematical modeling
and computer simulation." (Id. at 2:3--4.) Several diabetes simulators based
on population models are known. (Id. at 2: 13-18.) The Specification states
that, "for the purposes of artificial pancreas development, a different type of
computer simulator is needed - a system that is capable of simulating the
glucose-insulin dynamics of a particular person." (Id. at 3:3-5.)
Claims 1, 3, 9-12, 14, and 20-23 are on appeal. Claim 1 is illustrative
and reads as follows:
1. A computer-implemented method for testing of monitoring and/or
treatment strategies for diabetes using a computer simulation
environment including a computer-executable mathematical model of
the human glucose-insulin metabolic system and a database of a
population of simulated human subjects collectively having a set of
metabolic parameters with values encompassing a distribution of
observed parameters in diabetic subjects, comprising determining
effects of various monitoring and/or treatment strategies on said
metabolic parameters by executing said strategies using said
mathematical model in a computer processor.
The other independent claims are directed to a system environment
(claim 12) for carrying out the method of claim 1 and a computer program
product (claim 23) having instructions enabling a processor to practice the
method of claim 1.
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Application 12/664,444
The claims stand rejected as follows:
Claims 1, 3, 9, 12, 14, 20, and 23 under 35 U.S.C. § 103(a) as obvious
based on Schlessinger2 and Mougiakakou3 (Ans. 5) and
Claims 10, 11, 21, and 22 under 35 U.S.C. § 103(a) as obvious based
on Schlessinger, Mougiakakou, and Porumbescu4 (Ans. 7).
I
Issue
The Examiner has rejected claims 1, 3, 9, 12, 14, 20, and 23 as
obvious based on Schlessinger and Mougiakakou. The Examiner finds that
Schlessinger teaches a computer simulation method for testing monitoring or
treatment of diabetes that generates a population of simulated people,
including some with diabetes, having particular metabolic parameters. (Ans.
5.)
The Examiner finds that Mougiakakou teaches a mathematical model
of the human glucose-insulin metabolic system that includes metabolic
parameters of diabetic patients. (Id. at 6.) The Examiner concludes that it
would have been obvious to modify Schlessinger' s method to include
Mougiakakou's glucose-insulin metabolic model "in order to assist diabetes
patients to handle their blood glucose profile and recognize dangerous
metabolic states," as disclosed by Mougiakakou. (Id.)
2 Schlessinger et al., US 2007/0038475 Al, published Feb. 15, 2007.
3 Mougiakakou et al., A Real Time Simulation Model of Glucose-Insulin
Metabolism for Type 1 Diabetes Patients, Proceedings of the 2005 IEEE
Engineering in Medicine and Biology 27th Annual Conference 298-301
(2005).
4 Porumbescu, US 6,835,175 Bl, issued Dec. 28, 2004.
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Application 12/664,444
Appellants contend that "Schlessinger does not disclose a database of
simulated human subjects collectively having a set of metabolic parameters
with values encompassing a distribution of observed parameters in diabetic
subjects." (Appeal Br. 5.) Appellants also contend that "Mougiakakou
discloses a glucose-insulin metabolism simulation model for short-term
prediction of the glucose levels of a particular diabetes patient" (id. at 6) and
"[t]here simply would be no reason or purpose to be served by providing a
model to predict an actual patient's short-term blood glucose levels from
such patient's actual data in Schlessinger" (id. at 7).
The issue with respect to this rejection is whether it would have been
obvious to use Mougiakakou's glucose-insulin metabolic model in
Schlessinger's diabetes simulation.
Findings of Fact
1. Schlessinger states that its "invention relates to dynamic healthcare
modeling including applications to clinical trials and to diabetes
management and prevention." (Schlessinger i-f 2.)
2. Schlessinger states that"[ o ]ne can conceptualize the physiology of
a person as a collection of continuously interacting objects or 'features.'
The concept of a feature is very general, but they correspond roughly to
anatomic and biological variables." (Id. at i-f 29.)
3. Schlessinger discloses an embodiment in which "a virtual
population was generated 102 by 'giving birth' to a large number of
simulated people without restriction based on the trial procedure," after
which "the simulation grew each individual up from age=O." (Id. at i-f 46.)
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Application 12/664,444
(Id.)
4. Schlessinger states that
[t]he simulated babies spanned a wide distribution not only by
sex and race/ethnicity, but by all the other variables that
determine people's fates as they grow up, such as behaviours like
smoking, genetic propensities to be obese or develop plaque in
coronary arteries, and so forth.
5. Schlessinger states that its method was used to simulate the
CARDS (Collaborative Atorvastatin Diabetes Study) trial. (Id. at i-f 45.)
6. Schlessinger states that 4000 "simulated subjects" were selected as
trial candidates, the key characteristics of which (including incidence of
diabetes) were compared to actual CARDS trial subjects and were found to
be an acceptable statistical match. (Id. at i-f 54.)
7. Schlessinger states that the trial was then simulated using a
"simulated model [that] included hundreds of equations," including
equations for "glucose; basal hepatic glucose production; efficiency of
insulin use ... , insulin, [and] type 1 diabetes." (Id. at i-f 55.)
8. Schlessinger discloses "additional exemplary embodiments applied
to diabetes management and prevention." (Id. at i-f 59.)
9. Mougiakakou presents "a simulation model of glucose-insulin
metabolism for Type 1 diabetes patients." (Mougiakakou 298, abstract.)
10. Mougiakakou states that its "model aims at the development of an
accurate system, in order to assist Type 1 diabetes patients to handle their
blood glucose profile and recognize dangerous metabolic states." (Id.)
11. Mougiakakou states that "[t]he result[ing] blood glucose
predictions are promising for the use of the proposed model for blood
glucose level estimation for Type 1 diabetes patient[ s]." (Id.)
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Analysis
We agree with the Examiner that the method of claim 1 would have
been obvious based on the disclosures of the cited references. Schlessinger
discloses a method of modeling clinical trials having application to diabetes
management and prevention (FF 1 ). Schlessinger discloses an embodiment
in which a virtual population was generated having a wide distribution of
variables that affect health, and the subjects' health was simulated as they
grew up (FF3, FF 4 ). Schlessinger discloses that a set of its simulated
subjects was used to simulate an actual clinical trial using a model that
included equations to calculate various diabetes-related parameters for the
subjects (FF5-7).
Mougiakakou discloses a model for simulating glucose-insulin
metabolism in diabetic patients (FF9) and states that the predictions from the
model are promising for use in estimating blood glucose levels in a diabetic
patient (FF 11 ). Schlessinger' s method includes equations for calculating
"glucose, basal hepatic glucose production, efficiency of insulin use ... ,
insulin, [and] type 1 diabetes" in its simulated subjects (FF7). Thus, it
would have been obvious to use Mougiakakou' s model in Schlessinger' s
method in order to simulate glucose-insulin metabolism for the simulated
subjects in Schlessinger's database who have diabetes, and accurately
calculate diabetes-related parameters such as blood-glucose levels.
Appellants argue that "Schlessinger does not disclose a database of
simulated human subjects collectively having a set of metabolic parameters
with values encompassing a distribution of observed parameters in diabetic
subjects." (Appeal Br. 5.) Appellants also argue that "[t]he virtual
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population of Schlessinger thus is intended to mimic real life" (id.) and does
not "encompass[] a distribution of observed parameters in diabetic subjects."
(Id. at 6.)
This argument is unpersuasive, because the broadest reasonable
interpretation of claim 1 does not require that the database be limited to one
that includes only simulated subjects with diabetes. For example,
Appellants' Specification states that "[t]he population may be a
representative of the general diabetic population or other desired
demographic" (Spec. 3 :29-30); thus, the broadest reasonable interpretation
of the claim language includes a database that simulates real life and
includes subjects who collectively encompass a distribution of parameters
observed in diabetic patients, along with subjects who do not have diabetes.
Schlessinger' s database meets this limitation, because it includes
4000 simulated subjects whose characteristics were compared to actual
subjects in the CARDS (Collaborative Atorvastatin Diabetes Study), and the
comparison was found to be a statistically acceptable match. (Schlessinger
i-f 54: "If the comparison of the key characteristics had not been acceptable,
the selection process 108 could have been adjusted ... to achieve an
acceptable statistical match.")
Appellants also argue that "Mougiakakou discloses a glucose-insulin
metabolism simulation model for short-term prediction of the glucose levels
of a particular diabetes patient, based on information about that patient's
glucose levels, insulin intake, and diet during previous time periods."
(Appeal Br. 6.) Appellants argue that "[t]here simply would be no reason or
purpose to be served by providing a model to predict an actual patient's
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short-term blood glucose levels from such patient's actual data in
Schlessinger." (Id. at 7.)
This argument also does not persuade us that the rejection is in error.
Schlessinger' s method calculates individual parameters for each of the
simulated subjects in its database, as indicated by the disclosure that the
simulated babies are generated having a wide distribution of health-related
characteristics (FF4), after which "the simulation grew each individual up
from age=O" (FF3, emphasis added). Thus, it would have been obvious to
use a model, like Mougiakakou's, that accurately predicts blood glucose
levels in actual patients in Schlessinger' s method, in order to ensure that
Schlessinger's model accurately simulates the effect on its subjects of
parameters that affect the blood glucose level of real-life patients with
diabetes.
Conclusion of Law
It would have been obvious to use Mougiakakou's glucose-insulin
metabolic model in Schlessinger's diabetes simulation.
Claims 3, 9, 12, 14, 20, and 23 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
II
The Examiner has rejected claims 10, 11, 21, and 22 as obvious based
on Schlessinger, Mougiakakou, and Porumbescu. Claims 10 and 11 depend
from claim 1; claims 21 and 22 depend from claim 12. Claims 10 and 21
add the further limitation that the method or system includes a mathematical
model of subcutaneous insulin delivery via insulin pump. Claims 11 and 22
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Application 12/664,444
add the limitation that the method or system includes an interactive module
for allowing a user or device to interact with the method or system in order
to implement testing.
The Examiner finds that Porumbescu teaches "products capable to
make contemporaneous accurate predictions regarding how a person's
biological system will respond to a series of stimuli," including generating
time functions describing the time course of exogenous insulin following
infusion pump action. (Answer 7-8.) The Examiner also finds that
Porumbescu discloses that "the products include an interactive module for
allowing a user or device to interact with the testing method to implement
the testing method." (Id. at 8.)
The Examiner concludes that it would have been obvious to include
the features taught by Porumbescu in the method made obvious by
Schlessinger and Mougiakakou, "in order to provide a means of entering
data with new variables into the system in order to a [sic] run a specific
simulation and to create a realistic model wherein one of the variables is the
well-known patient's use of insulin in the treatment of their diabetes." (Id.)
We agree with the Examiner's fact-finding and conclusions. The
Examiner points to Porumbescu's disclosure that "[c]ontemporaneous
decision support in metabolic control may be achieved for diabetes, by ...
generating time functions describing the time course of the exogenous
insulin following an injection or infusion pump action," among other things.
(Porumbescu 7: 10-58.) We agree with the Examiner that it would have
been obvious to include a mathematical model of subcutaneous insulin
delivery via insulin pump, in order to increase the accuracy of diabetes
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Application 12/664,444
management and prevention (FF 1) in the method made obvious by
Schlessinger and Mougiakakou.
We also agree with the Examiner that it would have been obvious to
include an interactive module that allows a user or device to implement the
testing in the method suggested by Schlessinger and Mougiakakou.
Schlessinger discloses that after the characteristics of its simulated subjects
were compared to the real patients in the CARDS trial, "the trial was
simulated 110 and the trial data were collected 112." (Schlessinger i-f 55.)
Logically, in order for the trial to be simulated, a user or device must interact
with the hardware and software carrying out the simulation in order to
implement the testing. That additional feature therefore would have been
obvious to a person of ordinary skill in the art.
Appellants contend that Porumbescu's disclosure of "generating time
functions describing the time course of exogenous insulin following an
injection or infusion pump action ... does not correspond to a mathematical
model of subcutaneous insulin delivery via insulin pump used in a simulated
testing method as claimed." (Appeal Br. 8.)
However, "[ n ]on-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed.
Cir. 1986). Here, while Porumbescu does not teach use of its time functions
in a simulated testing method, such a method is taught by Schlessinger, and
the rejection is based on the combined disclosures of the cited references.
Appellants' argument does not persuade us that the method of claim 10
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would not have been obvious based on Schlessinger, Mougiakakou, and
Porumbescu.
Appellants also argue that Porumbescu' s disclosure of "entering
information from a user-patient and from bioassay equipment ... does not
correspond to an interactive module for allowing a user or device to interact
with said with said [sic] testing method to implement said testing method, as
set forth in the present claims." (Appeal Br. 8.)
As the Examiner pointed out (Ans. 12), however, the Specification
does not define the claimed module, other than stating that it allows a user or
device to interact with the testing method. (Spec. 4:1-3.) The broadest
reasonable interpretation of the claim language, read in light of the
Specification, is that it only requires the computer that implements the
method of claim 11 to include some programming ("module") that allows
either a user or a device to interact with the computer in order to implement
the method. Such a provision is implicit in Schlessinger's method, as
discussed above. Appellants' argument is therefore unpersuasive.
Claims 21 and 22 have not been argued separately and therefore fall
with claims 10 and 11. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm both of the rejections on appeal.
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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
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