Ex Parte Carrington et alDownload PDFPatent Trial and Appeal BoardAug 21, 201813805186 (P.T.A.B. Aug. 21, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/805, 186 12/18/2012 Nathan Allen Carrington 77741 7590 08/23/2018 Brannon Sowers & Cracraft PC 47 South Meridian Street Suite 400 Indianapolis, IN 46204 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. P26930-US-l-dc 9248 EXAMINER ROSENWALD, STEVEN ERIC ART UNIT PAPER NUMBER 1795 NOTIFICATION DATE DELIVERY MODE 08/23/2018 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): docket@bscattorneys.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte NATHAN ALLEN CARRINGTON, LEON SCOTT VAN DYKE, and STACY HUNT DUVALL Appeal2017-009986 Application 13/805, 186 Technology Center 1700 Before JEFFREY B. ROBERTSON, MONTE T. SQUIRE, and JENNIFER R. GUPTA, Administrative Patent Judges. GUPTA, Administrative Patent Judge. DECISION ON APPEAL 1 Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner's final decision rejecting claims 1-17 and 19-24. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 In this Decision, we refer to the Specification filed December 18, 2012 ("Spec."), the Final Office Action dated August 25, 2016 ("Final Act."), the Appeal Brief filed March 23, 2017 ("Appeal Br."), the Examiner's Answer dated May 18, 2017 ("Ans."), and the Reply Brief filed July 18, 2017 ("Reply Br."). 2 Appellant is the Applicant, Roche Diabetes Care, Inc., which, according to the Appeal Brief, is the real party in interest. Appeal Br. 2. We note that Roche Diagnostics Operations, Inc., identified as the assignee in the Appeal2017-009986 Application 13/805, 186 The subject matter on appeal relates to an electrochemical sensor for analytical detection, for example, an electrochemical sensor for monitoring blood glucose concentrations in an analyte. Spec. ,r,r 2--4. In one embodiment, the electrochemical sensor uses a test strip that includes an electrode, a chamber for depositing a sample, and a reagent composition that reacts with an analyte. Id. ,r 5. Claim 1, reproduced below from the Claims Appendix of the Appeal Brief, is illustrative of the claims on appeal. 1. An electrochemical sensor comprising an electrode, and a composition comprising a dried residue of (a) one or more enzymes selected from the group consisting of glucose dehydrogenases (GDH), glucose oxidoreductases, and combinations thereof; (b) one or more co-factors, co-enzymes, or a combination thereof for the one or more enzymes; ( c) one or more mediators, mediator precursors, or a combination thereof, wherein at least one mediator or mediator precursor is aqueous soluble; ( d) one or more zwitterionic buffers; and ( e) optionally one or more adjuvants. Appeal Br. 41 (Claims App.). REJECTIONS The Examiner maintains the following rejections on appeal: Rejection 1: Claims 1, 3, 6-16, and 19-24 are rejected under pre-AIA 35 U.S.C. § I03(a) as unpatentable over Nagakawa et al. (US 2007/0053790 Al, published March 8, 2007) ("Nagakawa") in view of Bhullar et al. (US 2005/0019212 Al, published January 27, 2005) ("Bhullar") (Ans. 2); Application Data Sheet filed December 2, 2014, assigned its rights to Roche Diabetes Care, Inc. on March 2, 2015. 2 Appeal2017-009986 Application 13/805, 186 Rejection 2: Claims 2 and 4 are rejected under pre-AIA 35 U.S.C. § I03(a) over Nagakawa in view of Bhullar and Yamoaka et al. (US 7,776,575 B2, issued August 17, 2010) ("Yamoaka") (Ans. 7); Rejection 3: Claim 5 is rejected under pre-AIA 35 U.S.C. § I03(a) over Nagakawa in view of Bhullar and Inamori et al. (US 2008/0248514 Al, published October 9, 2008) ("Inamori") (Ans. 8); Rejection 4: Claim 17 is rejected under pre-AIA 35 U.S.C. § I03(a) over N agakawa in view of Bhullar and Sparkes et al. (US 2006/01804 79 A 1, published August 17, 2006) ("Sparkes") (Ans. 9). DISCUSSION Rejection 1 Appellant argues the claims subject to the first-stated ground of rejection as a group. We limit our discussion to independent claim 1, and dependent claims 3, 6-16, and 19--24 will stand or fall with that claim. 37 C.F.R. § 4I.37(c)(l)(iv). Upon consideration of the evidence on this record and each of Appellant's contentions, we find that the preponderance of evidence supports the Examiner's conclusion that the subject matter of Appellant's claims is unpatentable over the applied prior art. We sustain the Examiner's first§ I03(a) rejection essentially for the reasons set out by the Examiner in the Final Office Action and Answer. We add the following. The Examiner finds that Nagakawa teaches claim 1 's composition, as shown in Table 1 reproduced below. Ans. 2-3 (citing Nagakawa ,r 96). 3 Appeal2017-009986 Application 13/805, 186 Thid,:nt:.ss Df TABLE I doubk-sided ---~R-e;_'lg-·r:,_ri_~-ol-u!-:io-n_~,~')'-np_. ~~~-\-tt_r>I-1 ___ Appfa,atk,u Pl (1) Glm:nse pmMJ U}O 1-un PIPES (pI-ni (BO n1\{1 ,1rnc,ur,t 4 pL '..: p.L Table 1 discloses a reagent solution applied to a region between a pair of double-sided tape of a glucose sensor. 3 Although Nagakawa primarily teaches a glucose sensor for measuring glucose concentration by colorimetry, the Examiner finds that Nagakawa also teaches glucose sensors for measuring glucose concentration by an electrode method. Ans. 3 (citing Nagakawa, ,r,r 12, 91). Based on this teaching, the Examiner finds that it would have been obvious to a person having ordinary skill in the art to use Nagakawa's reagent solution with an electrode to measure glucose concentration. Ans. 3. 3 In Table 1, PQQGDH is the abbreviation for glucose dehydrogenase (GDH) having pyrroloquinoline quinone (PQQ) as a coenzyme, PMS is the abbreviation for 5-methylphenazinium methylsulfate, MMT is the abbreviation for 3-(4,5-Dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide, and PIPES, a zwitterionic buffer, is the abbreviation for piperazine- 1,4-bis(2-ethanesulfonic acid). 4 Appeal2017-009986 Application 13/805, 186 Because Nagakawa does not teach any further detail regarding an electrode, the Examiner finds that one of ordinary skill in the art would look to the prior art in electrochemical sensing for guidance on placement of the electrode in the sensor, and electrochemical measurement. Final Act. 4. The Examiner finds that Bhullar teaches a system for assessing an analyte, preferably glucose, in a sample fluid, for example blood or interstitial fluid. Id. ( citing Bhullar, ,r 49). Bhullar teaches that one component of its system is an electrochemical sensor that has a sample-receiving chamber including an electrode and a suitable reagent to provide the electrochemical signal to an electrode positioned within the chamber. Id. ,r,r 51-52, 70-71. The Examiner finds that it would have been obvious to one of ordinary skill in the art, based on Bhullar, to provide an electrochemical sensor that includes a sample chamber with an electrode and Nagakawa's reagent composition overlying the electrodes to analyze a sample by an electrode method, as taught by Nagakawa. Final Act. 4. Appellant's argument that the combination ofNagakawa and Bhullar fail to teach, and actually teach away from an "electrochemical sensor that includes only a single reagent layer" (Appeal Br. 11-12) is not well-taken because as the Examiner aptly points out, claim 1 is not limited to a single reagent layer. Ans. 11. Appellant argues that hindsight gleaned from their disclosure was used improperly to pluck Nagakawa from the sea of prior art references known to the skilled artisan. Appeal Br. 12. Appellant further argues that once Nagakawa was in hand, "the Examiner compounded the taint of hindsight by again using Appellant's claimed invention as a lens through which the Examiner improperly focused on isolated disclosure within 5 Appeal2017-009986 Application 13/805, 186 Nagakawa in framing the standing obviousness rejection." Id. Appellant, therefore, contends that "[t]he only way to arrive at Appellant's invention is to use hindsight bias and improperly cherry pick the Example tools from the disclosure ofNagakawa and ignore the broader variations therein." Id. at 17. As Appellant admits, Nagakawa teaches that the first embodiment of its glucose sensor includes two facing reagent layers, and further teaches that the first embodiment of its glucose sensor can be used to measure glucose by colorimetry or an electrode method. Appeal Br. 8, 1 O; see also Nagakawa, ,r,r 12, 50-51, 91, and Ans. 11. Nagakawa's Table 1 teaches examples of reagent compositions used with the first embodiment of its glucose sensor. Appellant does not dispute that Table 1 's compositions fall within the scope of claim 1 's composition. See generally Appeal Br. 5-37. Based on Nagakawa's disclosure we are not persuaded that the Examiner erred in determining that claim 1 's electrochemical sensor would have been obvious over Nagakawa. Ans. 2-3. In re Mills, 470 F.2d 649, 651 ( CCP A 1972) ("All the disclosures in a reference must be evaluated, including nonpreferred embodiments"). Moreover, despite Appellant's contention (Appeal Br. 14), picking and choosing may be entirely proper in making an obviousness rejection. In re Arkley, 455 F.2d 586, 587-88 (CCPA 1972). Appellant argues that the Examiner has failed to articulate the requisite motivation to use Bhullar's electrode with Nagakawa's sensor. Appeal Br. 19. We disagree. As discussed above, Nagakawa expressly teaches that its reagent composition can be used for analyzing a sample by an electrode method. Nagkawa ,r,r 12, 91. Bhullar teaches an electrode method that uses a sensor 6 Appeal2017-009986 Application 13/805, 186 that has a sample-receiving chamber including an electrode and a reagent composition comprising an enzyme and a mediator. Appellant does not explain by persuasive technical reasoning or demonstrate by sufficient evidence that one of ordinary skill in the art would not have understood that Nagakawa's reagent solution is applicable to electrode methods that include a chamber with an electrode and a reagent composition overlying the electrode, as disclosed in Bhullar. KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) ( "When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability."); see also id. at 421 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton."). Appellant argues that the evidence presented in the Appeal Brief demonstrates that the claimed electrochemical sensor including a composition comprising a zwitterionic buffer have unexpected properties as compared to conventional electrochemical sensors including a composition comprising a phosphate buffer. Appeal Br. 24--31. Nagakawa teaches glucose sensors that use a reagent solution that includes a zwitterionic buffer, PIPES, not a phosphate buffer. Nagakawa ,r 96 (Table 1 ). Thus, Appellant's evidence is not persuasive because it does not provide a comparison with the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art."). 7 Appeal2017-009986 Application 13/805, 186 Moreover, despite Appellant's contentions (Appeal Br. 36), the Examiner does not rely on inherency to support the obvious rejection of claim 1. Rather, because Nagakawa teaches the same composition as recited in claim 1, the Examiner simply explains that it would be expected to have the same properties as claim 1 's composition, i.e., (a) improved maximum signal, (b) improved reaction kinetics to steady-state, ( c) improved performance across a wide range of operating temperatures, ( d) improved stability at elevated temperature, and ( e) improved long-term storage stability. Ans. 24--25; In re Spada, 911 F.2d 705, 708 (Fed Cir. 1990) ("Products of identical chemical composition cannot have mutually exclusive properties."). We also point out that those properties are not recited in claim 1. In sum, Appellant's arguments have been carefully considered, but are unpersuasive as to error in the rejection. Accordingly we sustain the Examiner's rejection of claims 1, 3, 6-16, and 19--24. Rejections 2-4 Although set out under separate headings, Appellant does not make additional arguments for the patentability of separately rejected claims 2, 4, 5, and 17. Rather, Appellant merely argues that the additional prior art relied on to reject those claims, i.e., Yamaoka (claims 2 and 4), Inamori ( claim 5), and Sparkes ( claim 17), does not cure the insufficiency of Nagakawa and Bhullar as to claim 1. Appeal Br. 37-39. Because we find no insufficiency in the Examiner's rejection of claim 1 over Nagakawa and Bhullar, we sustain the rejections of claims 2, 4, 5, and 17. 8 Appeal2017-009986 Application 13/805, 186 DECISION The rejection of claims 1, 3, 6-16, and 19--24 underpre-AIA 35 U.S.C. § 103(a) over Nagakawa and Bhullar is affirmed. The rejection of claims 2 and 4 under pre-AIA 35 U.S.C. § 103(a) over Nagakawa, Bhullar, and Yamoaka is affirmed. The rejection of claim 5 under pre-AIA 35 U.S.C. § 103(a) over Nagakawa in view of Bhullar and Inamori is affirmed. The rejection of claim 17 under pre-AIA 35 U.S.C. § 103(a) over Nagakawa in view of Bhullar and Sparkes 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 9 Copy with citationCopy as parenthetical citation