Ex Parte Bhavaraju et alDownload PDFPatent Trial and Appeal BoardMay 31, 201813836260 (P.T.A.B. May. 31, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/836,260 03/15/2013 68851 7590 06/04/2018 KNOBBE, MARTENS, OLSON & BEAR, LLP DEXCOM, INC. 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 FIRST NAMED INVENTOR Naresh C. Bhavaraju 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. DEXCOM.214A 8398 EXAMINER MESSERSMITH, ERIC J ART UNIT PAPER NUMBER 3735 NOTIFICATION DATE DELIVERY MODE 06/04/2018 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): j ayna.cartee@knobbe.com efiling@knobbe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NARESH C. BHA V ARAJU, SEBASTIAN BOHM, ROBERT J. BOOCK, DAITING RONG, and PETER C. SIMPSON1 Appeal2017-006221 Application 13/836,260 Technology Center 3700 Before DEMETRA J. MILLS, ERIC B. GRIMES, and RY ANH. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims to a method for processing data from a continuous glucose sensor. 2 The Examiner's rejections of claims 1-10, 12-16, and 20-23 under 35 U.S.C. § 102(b) and§ 103(a) are appealed. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 The Real Party in Interest is identified as "DexCom, Inc." Appeal Br. 3. 2 We have considered, and herein refer to, the Specification of Mar. 15, 2013 ("Spec."); Final Office Action of Dec. 4, 2015 ("Final Action"); Appeal Brief of Aug. 3, 2016 ("Appeal Br."); Examiner's Answer of Dec. 22, 2016 ("Answer"); and Reply Brief of Feb. 21, 2017 ("Reply Br."). Appeal2017-006221 Application 13/836,260 STATEMENT OF THE CASE The Specification states: Electrochemical sensors are useful in chemistry and medicine to determine the presence or concentration of a biological analyte. Such sensors are useful, for example, to monitor glucose in diabetic patients and lactate during critical care events. A variety of intravascular, transcutaneous and implantable sensors have been developed for continuously detecting and quantifying blood glucose values. Many conventional implantable glucose sensors suffer from complications within the body and provide only short-term or less-than-accurate sensing of blood glucose. Spec. ,r 4. Independent claim 1, reproduced below, is representative: 1. A method for processing data from a continuous glucose sensor, the method comprising: receiving sensor data generated by a continuous glucose sensor, wherein the sensor data is indicative of a concentration of glucose in a user; identifying, using a processor module, a post-implantation loss of sensitivity of the continuous glucose sensor, wherein identifying the post-implantation loss of sensitivity comprises determining a severity of the loss of sensitivity; processing the sensor data, using the processor module, responsive to the identification of the loss of sensitivity; and deactivating continuous glucose sensor system responsive to the determination of the occurrence of the post-implantation loss of sensitivity event. Appeal Br. 14 (Claims App'x). 2 Appeal2017-006221 Application 13/836,260 The following rejections are appealed: 3 Claims 1--4, 8, 10, 12-16, 20-21, and 23 stand rejected under 35 U.S.C. § I02(b) as anticipated by Keimel. 4 Final Action 3. Claim 5 stands rejected under 35 U.S.C. § I03(a) over Keimel and Willis. 5 Id. at 7. Claims 6, 7, and 22 stand rejected under 35 U.S.C. § I03(a) over Keimel and Bohm. 6 Id. Claim 9 stands rejected under 35 U.S.C. § I03(a) over Keimel and Brauker. 7 Id. at 8. DISCUSSION Only those arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision. Arguments not so presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BP AI 2010) (informative) ("Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived."). Statements in a brief that "merely mention [a] claim ... and lack any type of separate, substantive argument concerning the claim" are not sufficient to constitute 3 Claim 3 also stands rejected under 35 U.S.C. § 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim ( claim 1) upon which it depends. Appellants indicate that they do not appeal this rejection; thus, we affirm it. See Appeal Br. 5. 4 US 6,666,821 B2 (issued Dec. 23, 2003) ("Keimel"). 5 US 2007/0299617 Al (published Dec. 27, 2007) ("Willis"). 6 US 2012/0265035 Al (published Oct. 18, 2012) ("Bohm"). 7 US 2007 /0208246 Al (published Sept. 6, 2007) ("Brauker"). 3 Appeal2017-006221 Application 13/836,260 separate argument regarding that claim under 37 C.F.R. § 4I.37(c)(l)(iv). In re Kao, 639 F.3d 1057, 1065 (Fed. Cir. 2011). "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prim a f acie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference." In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Regarding obviousness, "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under§ 103." Id. at 419. The Examiner determined that the appealed claims are anticipated by Keimel and, regarding claims 5-7, 9, and 22, would have been obvious over Keimel in combination with one of Willis, Bohm, or Brauker, as respectively indicated in the Final Action and Answer. Final Action 2-9; Answer 2-12. 4 Appeal2017-006221 Application 13/836,260 Appellants present a single substantive argument for patentability and argue all claims as a group based on the patentability of claim 1. Appellants argue Keimel fails to teach the "identifying, using a processor module, a post-implantation loss of sensitivity of the continuous glucose sensor" claim 1 element ( emphasis added) because Keimel does not discuss "sensitivity," and, regarding the obviousness rejections, the combined prior art references fail to remedy this alleged shortcoming of Keimel. See Appeal Br. 9--12; Reply Br. 5-11. The determinative issue here is the interpretation of the claim 1 term "sensitivity." The Specification illuminates the meaning of this term in the context of the claims as follows: The terms "sensitivity" or "sensor sensitivity," as used herein, are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art ( and is not to be limited to a special or customized meaning), and refer without limitation to an amount of signal produced by a certain concentration of a measured analyte, or a measured species (such as, for example, H202) associated with the measured analyte (such as, for example, glucose). For example, in one embodiment, a sensor has a sensitivity of from about 1 to about 300 picoAmps of current for every 1 mg/dL of glucose analyte. Spec. ,r 122 (emphasis added). We, therefore, in accordance with the Specification and the ordinary and customary meaning of the claim term, interpret "sensitivity" broadly so as to refer to an amount of signal produced by a certain concentration of a measured analyte. Thus, if a given concentration of glucose or 02 or H202, for example, at a sensor produces a specific amount of signal, e.g., X picoAmps, at the sensor, if the amount of signal increases ( e.g., X + 1 picoAmps) or decreases ( e.g., X - 1 picoAmps) 5 Appeal2017-006221 Application 13/836,260 while the concentration of glucose or 02 or H202 is constant, that represents a loss in sensitivity; the sensor can no longer accurately indicate the analyte concentration by its signal - sensitivity is lost. Keimel discloses using a processor to determine if a sensor's performance is degrading/deteriorating/becoming inaccurate. Keimel 1 :37- 39, 4:24---63, 5:38-50, 7:20-27, Figure 7, claims 8, 26. Keimel explains that one reason for such loss of sensor performance relates to the deterioration of the catalyst of the sensor needed for the electrochemical reaction at the sensor that creates an electrical signal in response to the presence of an analyte. Keimel 4:52-60. Once (or as) this catalyst is lost, sensor sensitivity to the analyte is lost. Id. Keimel's system detects this loss in sensitivity. See, e.g., id. at 5:38-50. Because we are not persuaded by Appellants' arguments that Keimel' s system does not measure sensitivity loss, as discussed above, we affirm each of the rejections on appeal. All claims were argued together and fall with claim 1. SUMMARY The rejection under 35 U.S.C. § 112, paragraph four, is affirmed. The anticipation rejection is affirmed. The obviousness rejections are each 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 6 Copy with citationCopy as parenthetical citation