Peter Newman et al.Download PDFPatent Trials and Appeals BoardOct 19, 20212021002764 (P.T.A.B. Oct. 19, 2021) Copy Citation 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. 12/739,948 04/26/2010 Peter Michael Newman UBS-007US0 4274 160056 7590 10/19/2021 Aura IP Law PC 3217 Carson Street No. 294 Lakewood, CA 90712 EXAMINER RUFO, LOUIS J ART UNIT PAPER NUMBER 1795 NOTIFICATION DATE DELIVERY MODE 10/19/2021 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): USPTO@dockettrak.com docketing@auraiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PETER MICHAEL NEWMAN and ALASTAIR M. HODGES ____________ Appeal 2021-002764 Application 12/739,948 Technology Center 1700 ____________ Before JEFFREY T. SMITH, LILAN REN, and MERRELL C. CASHION, JR., Administrative Patent Judges. CASHION, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to finally reject claims 1–7 and 13.2 We have jurisdiction under 35 U.S.C. § 6(a). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Universal Biosensors Pty Ltd as the real party in interest. Appeal Br. 3. 2 An oral hearing was scheduled for September 28, 2021. However, the hearing was waived on August 26, 2021. Appeal 2021-002764 Application 12/739,948 2 The invention relates generally to a sensor with opposing electrodes and test strips using this sensor. Spec. ¶¶ 1, 19. Claim 1, reproduced from the Claims Appendix to the Appeal Brief, illustrates the invention: 1. An opposing-electrode sensor comprising a working electrode, a counter electrode, an activator, and an electrochemical thrombin substrate, wherein the working electrode and the counter electrode are coated on respective supports and are separated by an insulating separator layer, wherein the activator is coated onto one of the electrodes and the electrochemical thrombin substrate is coated onto the other electrode, wherein the sensor detects cleavage of the electrochemical thrombin substrate in the presence of a sample. Appeal Br. 24 (Claims App.). The Examiner maintains the following rejections for review on appeal: I. claims 1–7 rejected under 35 U.S.C. § 103(a) as unpatentable over Frenkel (US 6,352,630 B1, issued March 5, 2002), Hodges (US 6,444,115 B1, issued September 3, 2002), Harding (US 2007/0235329 Al, published October 11, 2007), and Unkrig (US 2003/0146113 Al, published August 7, 2003); and II. claim 13 rejected under 35 U.S.C. § 103(a) as unpatentable over Frenkel, Hodges, Harding, Unkrig, and Essenpreis et al (US 6,413,213 B1, issued July 2, 2002). Appellant presents arguments only for independent claim 1 (Rejection I) and dependent claim 13 (Rejection II). See generally Appeal Br. Appellant relies on these arguments to address the rejections of the remaining claims. Id. Accordingly, we select independent claims 1 and 13 as representative of the subject matter claimed and decide the appeal as to all grounds of rejections based on the arguments presented for claims 1 and 13. Appeal 2021-002764 Application 12/739,948 3 OPINION After review of the respective positions of Appellant and the Examiner, we affirm the Examiner’s rejection of claims 1–7 and 13 under 35 U.S.C. § 103(a) for essentially the reasons the Examiner presents. We add the following for emphasis. Claim 1 (Rejection I) Claim 1 recites an opposing-electrode sensor comprising a working electrode and a counter electrode coated on respective supports, where the working electrode and the counter electrode are separated by an insulating separator layer. The Examiner finds Frenkel discloses an opposing electrode sensor comprising a working electrode, a counter electrode, an activator, and an electrochemical thrombin substrate that differs from the claimed invention in that Frenkel fails to disclose (1) coating each of the activator and the electrochemical thrombin substrate on separate electrodes of the working electrode and the counter electrode and (2) the working electrode and the counter electrode are coated on respective supports and are separated by an insulating layer. Final Act. 3–4; Frenkel Abstr., Figures 1–2, col. 5, l. 48– col.6, l. 51. The Examiner relies on the combined teachings of Hodges, Harding, and Unkrig to meet the missing structural features recited in differences (1) and (2) above. Final Act. 4; Hodges Figure 2, col. 5, ll. 5–15, 35–40; Harding Abstr., Figure 2A; Unkrig ¶¶ 41. The Examiner determines it would have been obvious to one of ordinary skill in the art at the time the invention was made to arrive at the subject matter of claim 1 from the combined teachings of the cited art. Final Act. 4–5. Appeal 2021-002764 Application 12/739,948 4 Appellant argues Frenkel is directed to a sensor comprising co-planar electrodes and not opposing electrodes as claimed. Appeal Br. 7–9. According to Appellant, the ordinary meaning of the term “opposing” is “facing” or “opposite.” Id. at 9. Appellant further argues Frenkel does not teach the claimed sensor configuration. Id. at 7. Appellant’s arguments do not identify error in the Examiner’s determination of obviousness because the arguments do not address the rejection the Examiner presents. In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 425 (CCPA 1981) (“[T]he test [for obviousness] is what the combined teachings of the references would have suggested to those of ordinary skill in the art.”); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“the [obviousness] 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”). While Appellant’s arguments contend Frenkel does not teach certain claimed structural features, these arguments do not address the Examiner’s reliance on the secondary references to address those features. Final Act. 4–5; Ans. 8–11. Appellant argues Hodges cannot be combined with Frenkel because Hodges involves a chemical sensing technique different from the one Frenkel discloses. Appeal Br. 11–13. According to Appellant, Hodges opposing electrode configuration is limited to blood glucose measurement. Id. Appeal 2021-002764 Application 12/739,948 5 These arguments are also unpersuasive of reversible error in the Examiner’s determination of obviousness. Hodges discloses a co-planar electrode configuration (Figure 1) and an opposing electrode configuration (Figure 2) as known alternate ways of arranging electrodes in a sensing device. As the Examiner explains in the Answer, Hodges exemplifies the use of the opposing electrode configuration with blood glucose measurements. Ans. 9. Hodges discloses “[a] method [] useful in applications where it is desirable to follow the progress of a chemical reaction, particularly in sensor applications where the progress of the reaction of an analyte can be useful in determining the analyte concentration.” Hodges col. 1, ll. 8–12. Hodges further discloses the measurement of blood glucose is “[a]n example of a chemistry and reaction that is suitable for use with the current invention . . .” Hodges col. 5, ll. 66– 67. Appellant acknowledges this disclosure. See Appeal Br. 10 (citing to the noted passage from column 5 of Hodges). To the extent one exemplary embodiment of Hodges describes the measurement of blood glucose, we decline to limit Hodges’s teachings and suggestions to this particular exemplary embodiment. It is well settled that a reference may be relied upon for all that it discloses and not merely the preferred embodiments as suggested by Appellant. See Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“[A]ll disclosures of the prior art, including unpreferred embodiments, must be considered.”) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)); see also In re Fracalossi, 681 F.2d 792, 794 n.1 (CCPA 1982) (explaining that a prior art reference’s disclosure is not limited to its examples). The disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or Appeal 2021-002764 Application 12/739,948 6 non-preferred embodiments. In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). Appellant has not explained adequately why Hodges’s disclosure of this exemplary embodiment limits or teaches away from Hodges’s broader disclosure. Appellant’s arguments that Frenkel and Hodges employ different chemical sensing techniques are also unpersuasive given that both references disclose using the technique of amperometry to conduct measurements. Appeal Br. 11; Frenkel col. 1, l. 16; Hodges col. 1, l. 8. Appellant argues Unkrig is directed to a coplanar electrode sensor and, thus, does not teach or disclose providing the activator and the electrochemical thrombin substrate on opposing surfaces of the working electrode and the counter electrode. Appeal Br. 14. Appellant further argues Unkrig discloses drying reagents in different locations under specific conditions but does not teach coating the reagents on opposing electrodes. Id. at 14–15. Appellant’s arguments do not identify error in the Examiner’s determination of obviousness. Unkrig discloses using a two-electrode system in which one electrode operates as a counter electrode and the other electrode operates as a working electrode. Unkrig ¶¶ 7, 15. While Unkrig appears to exemplify a co-planar electrode configuration (Unkrig ¶ 44), we find no disclosure that the teachings of Unkrig are limited to this electrode configuration. On the contrary, Unkrig’s earlier disclosure in paragraph 15 suggests that Unkrig is not limited to any electrode configuration. Given that Hodges discloses a co-planar electrode configuration (Figure 1) and an opposing electrode Appeal 2021-002764 Application 12/739,948 7 configuration (Figure 2) as known alternate ways of arranging electrodes in a sensing device, Appellant fails to explain why one skilled in the art, using no more than ordinary creativity, would not have been capable of determining the appropriate electrode configuration for a given measurement and, thus, arrive at the claimed invention from the teachings of the cited art. See KSR, 550 U.S. at 421 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”); see also In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (presuming skill on the part of one of ordinary skill in the art). Regarding the reagents, both the Examiner and Appellant acknowledge that Unkrig teaches drying reagent at different locations. Appeal Br. 14; Ans. 10. Appellant, however, contends that Unkrig’s “different locations” does not include individual application of the reagents on opposing electrodes. Appeal Br. 14–15; Unkrig ¶ 41. We remain unpersuaded of reversible error in the Examiner’s determination of obviousness. The relevant portion of Unkrig discloses “[i]t is also possible to apply individual components of the reagent to different compartments of the test support, for example the thrombin substrate on or directly adjacent to the electrode, but the activator spatially separated therefrom ( e.g. further removed from the electrode)” (emphasis added). Unkrig ¶ 41. The Examiner explains in the Answer, “Unkrig provides no degree of required separation OR no disclosure that if the thrombin substrate in on one electrode, then the activator cannot be on the other electrode” to spatially separate the activator from the electrode comprising the thrombin substrate. Appeal 2021-002764 Application 12/739,948 8 Ans. 11–12. We agree with the Examiner’s determination that one skilled in the art would have reasonably inferred from Unkrig’s disclosure that the thrombin and the activator can be individually applied to the different electrodes. See In re Fritch, 972 F.2d 1260, 1264–65 (Fed. Cir. 1992) (holding that a reference stands for all of the specific teachings thereof as well as the inferences one of ordinary skill in the art would have reasonably been expected to draw therefrom). Moreover, per our discussion above, Unkrig is not limited to any electrode configuration and, thus, encompasses a parallel electrode configuration. Appellant fails to explain why one skilled in the art, using no more than ordinary creativity, would not have been capable of providing the requisite spatial separation between the thrombin substrate and the activator components of the reagents by coating these components on opposing surfaces of a working electrode and a counter electrode. See KSR, 550 U.S. at 421; see also Sovish, 769 F.2d at 743. We have also considered Appellant’s arguments with respect to Harding but find them unavailing for the reasons the Examiner presents. Appeal Br. 17–18; Ans. 13–14. Moreover, while Appellant argues that Frenkel and Harding solve a similar problem using different techniques (chemical reaction v. mechanical flow, respectively), they both rely on amperometry to obtain a measurement. Appeal Br. 17; Frenkel col. 1, l. 16; Harding ¶ 16. Thus, Appellant has not explained adequately why the teachings of Harding are not relevant to Frenkel. Nor has Appellant explained sufficiently why an opposing-electrode sensor having the structural features taught by Harding would be unsuitable for Frenkel’s purposes. Appeal 2021-002764 Application 12/739,948 9 Arguments not specifically addressed are deemed not persuasive for the reasons the Examiner presents. Accordingly, we affirm the Examiner’s prior art rejection of claims 1– 7 under 35 U.S.C. § 103(a) for the reasons the Examiner presents and we give above. Claim 13 (Rejection II) Claim 13 depends from claim 7 and, thus, recites a test strip for measuring blood or plasma coagulation time in a sample, where the test strip comprises the sensor of claim 1 and further comprises a means for verifying strip integrity. The Examiner relies on the additional reference to Essenpreis as disclosing it is known to use a test meter to verify strip integrity. Final Act. 6; Essenpreis col. 8, l. 63–col. 9, l. 14. Appellant contends the Examiner misapprehended the teachings of Essenpreis because the reference does not concern a means for verifying test strip integrity but instead concerns methods for ensuring compliance in a meter subscription scheme, such that the intended meters and strips are being used and that the subscription period has not expired. Appeal Br. 22. We understand this argument as asserting that Essenpreis’s integrity test meter cannot be combined with the teachings of the previously discussed prior art. However, the Examiner relies principally on Essenpreis to teach that the concept of conducting a test strip integrity check for a given purpose is known. Moreover, Appellant acknowledges in the Specification, through incorporation by reference of US 2005/0123441 A1 to Unkrig et al. (published June 9, 2005), that it is known to provide an analytical device (test strip) with a test meter to verify strip integrity. Spec. ¶ 52; see Unkrig Appeal 2021-002764 Application 12/739,948 10 et al., ¶ 13. Thus, Appellant fails to explain why one skilled in the art, using no more than ordinary creativity, would not have been capable of providing a test strip with a means for verifying strip integrity as recited in claim 13. Accordingly, we affirm the Examiner’s prior art rejection of claim 13 under 35 U.S.C. § 103(a) for the reasons the Examiner presents and we give above. CONCLUSION The Examiner’s prior art rejections of claims 1–7 and 13 are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–7 103 Frenkel, Hodges, Harding, Unkrig 1–7 13 103 Frenkel, Hodges, Harding, Unkrig, Essenpreis 13 Overall Outcome 1–7, 13 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)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation