Ex Parte Shah et al

Patent Trial and Appeal BoardNov 4, 2014

11397543 (P.T.A.B. Nov. 4, 2014)

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. 11/397,543 04/04/2006 Rajiv Shah G&C 130.77-US-01 5966 12813 7590 11/05/2014 Gates & Cooper LLP - Minimed 6701 Center Drive West Los Angeles, CA 90045 EXAMINER CARLSON, KOURTNEY SALZMAN ART UNIT PAPER NUMBER 1756 MAIL DATE DELIVERY MODE 11/05/2014 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RAJIV SHAH, UDO HOSS, REBECCA K. GOTTLIEB, GOPIKRISHNAN SOUNDARARAJAN, and JAMES D. HOLKER1 ____________ Appeal 2013-001732 Application 11/397,543 Technology Center 1700 ____________ Before CHARLES F. WARREN, PETER F. KRATZ, and JEFFREY W. ABRAHAM, Administrative Patent Judges. ABRAHAM, Administrative Patent Judge. DECISION ON APPEAL This is a decision on an appeal under 35 U.S.C. § 134 from the decision of the Primary Examiner finally rejecting claims 1, 5, 6, 8, 12, 13, 53, 57, and 58.2 We have jurisdiction pursuant to 35 U.S.C. § 6(b). We affirm. 1 According to the Appeal Brief, the Real Party in Interest is Medtronic, MiniMed, Inc. App. Br. 2. 2 The Examiner also rejected claims 14, 16–18, 56, and 59–65 in the Final Action, but Appellants subsequently cancelled these claims. See Amendment filed January 26, 2012 at 2. Appeal 2013-001732 Application 11/397,543 2 BACKGROUND Appellants’ claimed invention relates to “devices and methods for controlling the electrochemistry of analyte sensors such as glucose sensors used in the management of diabetes.” Spec. 1:11–12. Claim 1 is the only independent claim on appeal, and is reproduced below from the Claims Appendix (App. Br. 8): 1. A method of performing an electrochemical reaction within an analyte sensor, the method comprising: using an analyte sensor constructed to perform an electrochemical reaction when exposed to an analyte, wherein the analyte sensor includes: at least one electrode disposed upon a base substrate comprising an electrically insulative material having a geometric feature comprising at least three rows of depressions or at least three rows of ridges, wherein the geometric feature is selected to increase the surface area of an electrochemically reactive surface on the electrode disposed thereon such that surface area to volume ratio of the electrochemically reactive surface area of the electrode disposed on the geometric feature is greater than surface area-to-volume ratio of the reactive surface of the electrode when disposed on a flat surface; an analyte sensing layer disposed on the electrode, wherein the analyte sensing layer comprises albumin in combination with glucose oxidase; an analyte modulating layer disposed on the analyte sensing layer, wherein the analyte modulating layer is formed from a siloxane composition and modulates the diffusion of the analyte therethrough; and a cover layer disposed on at least a portion of the analyte modulating layer; and Appeal 2013-001732 Application 11/397,543 3 exposing the analyte sensor to an analyte so that a electrochemical reaction is performed within the analyte sensor. Appellants appeal (i) the rejection of claims 1, 5, 6, 8, 12, 13, and 53 as unpatentable under 35 U.S.C. § 103 over Moser (US 2005/0205422 A1, published Sep. 22, 2005) in view of Shah (US 2004/0064156 A1, published Apr. 1, 2004); (ii) the rejection of claim 57 as unpatentable under 35 U.S.C. § 103 over Moser in view of Shah, and further in view of Holker (US 2004/0074785 A1, published April 22, 2004); and (iii) the rejection of claim 58 as unpatentable under 35 U.S.C. § 103 over Moser in view of Shah, and further in view of Rhodes (US 2005/0103625 A1, published May 19, 2005). Appellants present arguments directed at limitations in independent claim 1. Appellants state, without elaboration, that dependent claims 5, 6, 8, 12, 13, 53, 57, and 58 “recite a number of additional novel elements not shown by combinations” of the cited prior art. App. Br. 7. In the absence of any persuasive arguments directed towards specific elements of the dependent claims, claims 5, 6, 8, 12, 16, 53, 57, and 58 will stand or fall together with our analysis of independent claim 1. OPINION The dispositive issue in this appeal is: Did the Examiner err in determining that Moser teaches a base substrate having a geometric feature comprising at least three rows of depressions or at least three rows of ridges, as required in claim 1? We answer this question in the negative. Appeal 2013-001732 Application 11/397,543 4 Moser discloses an enzyme electrode arrangement comprising a substrate (7) with a roughened surface as depicted in Figure 3. See Moser, Abstract and Fig. 3. Moser teaches that the surface roughness helps to enable “the fast and highly precise measurement of the respective analytes without the occurrence of interference effects during prolonged use.” Id. at ¶ 19. According to Moser, the roughened surface can be generated by etching the substrate. Id. at ¶¶ 26–27. The Examiner finds that the roughened surface of Moser’s substrate features a curvilinear design, and, therefore, comprises geometric features. Ans. 4–5, 11. The Examiner further finds that “each roughened part of the strip creates a depression or trough and as shown in figure 3 there are an excess of three depressions.” Id. at 5. It is the Examiner’s position that Moser’s substrate contains more than three rows of depressions or ridges because Figure 3 represents only one row or cross section of the substrate, and there are an infinite number of other cross sections or rows that can be taken along the length of the strip. Id. The Examiner also finds that each ridge or depression shown in Figure 3 represents a row extending along the longitudinal length of the substrate (into the plane of the page). Id. According to the Examiner, under this interpretation, Figure 3 depicts more than three rows of ridges. Id. at 5– 6. The Examiner thus concludes that Moser discloses the required geometric feature of claim 1. Appeal 2013-001732 Application 11/397,543 5 Appellants argue that “the Moser disclosure fails to teach or suggest a geometric feature comprising at least three rows of depressions or at least three rows of ridges as recited in claim 1.” App. Br. 5. According to Appellants, Moser discloses only rough, irregular substrates, which are different from the repeating patterns of geometric features recited in claim 1. Id. Appellants further argue that the disclosure in Moser is not sufficient to have motivated those skilled in this technology to: (1) slice and/or dice the base structure shown in Figure 3 into “an infinite number of other cross sections” and/or extend each ridge so that it represents one row which extends along the length of the sensor so that the magnified portion presented to artisans only represents a cross section. Reply Br. 5. Appellants contend that the Examiner has “employ[ed] mental gymnastics that are alien to those of skill in this technology” to find that Moser describes the recited patterns of geometric features, and that persons of skill in the art “would not agree with the logic used by the Examiner to expand the Moser disclosure.” Id. at 6. We are not persuaded by Appellants’ arguments. Claim 1 does not include specific requirements for the depressions or ridges that make up the “geometric feature” of the base substrate. The Specification is likewise largely silent in this regard, offering only that a row of ridges can resemble zebra stripes. Spec., e.g., 15:16–19. Accordingly, we find that the Examiner reasonably concluded that the substrate surface depicted in Figure 3 of Moser has a geometric feature comprising depressions and/or ridges. Appeal 2013-001732 Application 11/397,543 6 We also find that the Examiner reasonably concluded that the substrate in Moser contains at least three rows of ridges and/or depressions. Figure 3 is a two-dimensional depiction of a three-dimensional electrode. It does not require “mental gymnastics” that are alien to persons of ordinary skill in the art to envision that the roughened surface extends into the plane of the page, such that the multiple depressions shown in Figure 3 represent rows of depressions in the actual electrode structure disclosed in Moser. Moreover, aside from attorney argument, Appellants have not directed us to any factual evidence in this record demonstrating why persons of skill in the art “would not agree with the logic used by the Examiner.” See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)(holding that attorney argument cannot take the place of evidence). In addition, Appellants do not identify any error in the Examiner’s finding that both the subject Specification and Moser disclose the use of etching to create the required geometric feature comprising at least three rows of depressions or ridges. Ans. 14–15. Nor do Appellants provide any “further clarification in its arguments or [S]pecification as to how the etching or lithography practices of [their] own work and that of MOSER et al are different or how they create such argued different substrates.” Id. at 15. Accordingly, we agree with the Examiner that Moser discloses a substrate having a geometric feature comprising at least three rows of depressions or at least three rows of ridges, as required in claim 1. Appeal 2013-001732 Application 11/397,543 7 We have considered the additional arguments presented by Appellants, many of which relate to features or characteristics of analyte sensors that are not recited in the claims at issue on appeal. See App. Br. 4–7; Reply Br. 3–6. We find these arguments to be unpersuasive, substantially in view of the findings of fact and responses expressed by the Examiner in the Final Action and the Answer. See Ans. 11–18. CONCLUSION For the reasons set forth above, we affirm the rejection of claims 1, 5, 6, 8, 12, 13, 53, 57, and 58 under 35 U.S.C. § 103. The Primary Examiner’s decision 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). AFFIRMED lp