Ex Parte Kovatchev et alDownload PDFPatent Trial and Appeal BoardJul 11, 201612664444 (P.T.A.B. Jul. 11, 2016) Copy Citation 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.) Appeal2014-001168 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. 2 Appeal2014-001168 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. 3 Appeal2014-001168 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.) 4 Appeal2014-001168 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.) 5 Appeal2014-001168 Application 12/664,444 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 6 Appeal2014-001168 Application 12/664,444 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 7 Appeal2014-001168 Application 12/664,444 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 8 Appeal2014-001168 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 9 Appeal2014-001168 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 10 Appeal2014-001168 Application 12/664,444 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. 11 Appeal2014-001168 Application 12/664,444 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 12 Copy with citationCopy as parenthetical citation