Ex Parte Labgold et alDownload PDFPatent Trial and Appeal BoardJul 10, 201412212007 (P.T.A.B. Jul. 10, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 12/212,007 09/17/2008 Marc Robert Labgold SIOM-0002-UT1 9536 80308 7590 07/10/2014 Steven B. Kelber Alchemy-Partners, PC 5885 Trinity Parkway Suite 370 Centreville, VA 20120 EXAMINER KESSEL, MARIS R ART UNIT PAPER NUMBER 1759 MAIL DATE DELIVERY MODE 07/10/2014 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 MARC ROBERT LABGOLD and GEORGE G. JOKHADZE ____________ Appeal 2013-002227 Application 12/212,007 Technology Center 1700 ____________ Before CHUNG K. PAK, TERRY J. OWENS , and PETER F. KRATZ, Administrative Patent Judges. PAK, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal1under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1, 3 through 7, 9 through 11, and 13 through 21. Claims 2, 8, and 12, and 22 through 27, the other claims pending in the above-identified application, stand withdrawn from consideration by the Examiner. A hearing was held on June 19, 2014. We have jurisdiction pursuant to 35 U.S.C. § 6. We AFFIRM-IN-PART. STATEMENT OF THE CASE The subject matter on appeal is directed to assay systems and methods for “the detection of target substances in a larger volume.” (Spec. 2, ¶ 5.) Details of 1 Appeal Brief filed July 30, 2012 (“App. Br.”) at 1 and 4. Appeal 2013-002227 Application 12/212,007 2 the appealed subject matter are recited in representative claims 1, 5, 11, and 21 reproduced below from the Claims Appendix of the Appeal Brief: 1. An assay system for the detection of a target in a liquid sample, wherein said assay system consists essentially of: a first capture moiety which binds to any target present in said sample, said first capture moiety complexed with an enzymatic redox reaction component which enzyme is a an oxidase or dehydrogenase of a substrate; a second capture moiety which bind to any said target present in said sample in a way not to interfere with binding of said first capture moiety to said target, said second capture moiety being bound to a an element that facilitates separation of target bound thereby from the remainder of said sample; a substrate recognized by said enzyme, which substrate, when acted upon by said enzyme, releases electrons; and a circuit which detects the presence of electric potential, electric current, or both, developed by the release of electrons from said substrate when digested by said enzyme. 5. An assay system for the detection of a target in a sample, wherein said assay system consists essentially of: a first capture moiety which binds to any target present in said sample, said first capture moiety complexed with an enzymatic redox reaction component which enzyme is a an oxidase or dehydrogenase of a substrate; a substrate recognized by said enzyme, which substrate, when acted upon by said enzyme, releases electrons; and a circuit which detects the presence of electric potential, electric current, or both, developed by the release of electrons from said substrate when acted upon by said enzyme. Appeal 2013-002227 Application 12/212,007 3 11. An assay method for detecting the presence of a target in a sample, said method comprising using the assay system of Claim 1 wherein said first capture moiety and said second capture moiety are combined with said sample under conditions which permit binding of said first and second capture moiety to any said target in said sample, any said target in said sample bound by said first and second capture moieties is retained by retaining said collection moiety, thereafter said substrate is added to said bound target, wherein any potential or current generated by reaction between said oxidase or dehydrogenase and said substrate is detected as a signal reflecting the presence of said target in said sample. 21. An assay method for detecting the presence of a target in a sample, said method comprising using the assay system of Claim 5, wherein said first capture moiety complexed with an oxidase or dehydrogenase of a substrate is combined with said sample under conditions which permit binding of said first capture moiety to and said target in said sample and thereafter said substrate is added to said sample, wherein any electric potential or current generated by the action of said enzyme upon said substrate is detected as indicating the presence of said target in said sample. (Emphasis added.) The Examiner maintains the following grounds of rejection in the Examiner’s Answer mailed October 2, 2012 (“Ans.”): 1. Claims 1, 4 through 7, 9, 11, 13, 15 through 17, and 21 stand provisionally rejected on the ground of non-statutory obviousness-type double patenting over claims 1, 2, 4, 7 through 14, 16, 18 through 22 and 24 of U.S. Patent Application 12/211,992 filed September 17, 2008; 2. Claims 1, 3 through 7, 9 through 11, 13, 14, 16, and 19 through 21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Robinson;2 2 G.A. Robinson et al., Bioelectrochemical Enzyme Immunoassay of Human Choriogonadotropin with Magnetic Electrodes, 31 CLINICAL CHEMISTRY 1449 (1985) (“Robinson”). Appeal 2013-002227 Application 12/212,007 4 3. Claim 15 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Robinson in view of Yamauchi;3 and 4. Claims 17 and 18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Robinson in view of Boitieux.4 DISCUSSION I. OBVIOUSNESS-TYPE DOUBLE PATENTING Appellants do not question the propriety of the Examiner’s obviousness-type double patenting rejection of claims 1, 4 through 7, 9, 11, 13, 15 through 17and 21 as unpatentable over the claims of U.S. Patent Application 12/211,992 set forth in the Answer. (App. Br. 18.) Thus, we summarily affirm this rejection. II. 35 U.S.C. § 103 Upon consideration of the evidence on this record, we concur with Appellants that the Examiner has not demonstrated that one of ordinary skill in the art, armed with the knowledge reflected in the applied prior art, would have been led to the subject matter recited in claims 1, 3 through 7, 9 through 11, and 13 through 21 within the meaning of 35 U.S.C. § 103(a). In particular, the Examiner has not carried the burden of demonstrating that Robinson’s circuit for amperometric measurement of glucose oxidase reaction5 or for detection of an 3 U.S. Patent 5,516,644 issued to Yamauchi et al. on May 14, 1996 (“Yamauchi”). 4 Jean-Louis Boitieux et al, Oxygen Electrode-Based Enzyme Immunoassay for the Amperometric Determination of Hepatitis B Surface Antigen, 163 ANALYTICA CHIMICA ACTA 309 (1984) (“Boitieux”). 5 Moreover, the Examiner has not shown that the amperometric measurement of glucose oxidase reaction taught by Robinson involves the measurement of “electric potential, electric current, or both, developed by the release of electrons from [a] substrate” when digested or acted upon by an enzyme. The Examiner has not contradicted or explained relevance of Appellants’ literature evidence, e.g., Appeal 2013-002227 Application 12/212,007 5 applied current required to reoxidize a ferrocene derivative is capable of detecting the presence of electric potential and/or electric current developed by the release of electrons from a substrate when it is digested or acted upon by an enzyme as explained by Appellants at pages 18 through 22 of the Appeal Brief and pages 2 through 7 of the Reply Brief. On the present record, the Examiner has not proffered any evidence to show that the claimed functionally defined circuit designs are identical or substantially identical to the circuit design taught by Robinson. Cf. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Nor has the Examiner proffered any evidence to show that any known circuit design, inclusive of Robinson’s circuit design, is capable of detecting the presence of electric potential and/or electric current developed by the release of electrons from a substrate digested by or acted upon by an enzyme as asserted by the Examiner. (Ans. 4-23.) In other words, the Examiner has not demonstrated that the circuit design taught by Robinson inherently or necessarily has the function recited in the claims on appeal. As stated by the predecessor to our reviewing court in In re Oelrich, 666 F.2d 578, 581 (CCPA 1981), “[i]nherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” The Examiner has also relied upon the disclosure of Yamauchi or Boitieux to show the features recited in dependent claims 15, 17, and/or 18. However, neither Boitieux relied upon by the Examiner, which is said to show that amperometric detection or measurement involves the measurement of oxygen consumption. (Compare App. Br. 22 with Ans. 4-23.) The Examiner has not shown that the circuit used for oxygen consumption measurement taught by Robinson, as explained by Boitieux, is capable of detecting the presence of electric potential and/or electric current developed by the release of electrons from a substrate digested by or acted upon by an enzyme as required by the claims on appeal. (Ans. 4-23.) Appeal 2013-002227 Application 12/212,007 6 Yamauchi nor Boitieux is relied upon to provide a disclosure that would remedy the above discussed deficiency in Robinson. Accordingly, we are constrained to reverse the Examiner’s § 103(a) rejections for the reasons set forth by Appellants in the Appeal Brief. ORDER Upon consideration of the record, and for the reasons given above, it is ORDERED that the decision of the Examiner to provisionally reject claims 1, 4 through 7, 9, 11, 13, 15 through 17 and 21 on the ground of non-statutory obviousness-type double patenting over the claims of U.S. Patent Application 12/211,992 filed September 17, 2008 is AFFIRMED; FURTHER ORDERED that the decision of the Examiner to reject claims 1, 3 through 7, 9 through 11, and 13 through 21 under 35 U.S.C. § 103(a) is REVERSED; and FURTHER ORDERED that 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). AFFIRMED-IN-PART bar Copy with citationCopy as parenthetical citation