Ex Parte Belenky et alDownload PDFBoard of Patent Appeals and InterferencesMar 1, 201111089261 (B.P.A.I. Mar. 1, 2011) 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. 11/089,261 03/24/2005 Alexander Belenky BYR-84 (MST-2432) 8134 28524 7590 03/01/2011 SIEMENS CORPORATION INTELLECTUAL PROPERTY DEPARTMENT 170 WOOD AVENUE SOUTH ISELIN, NJ 08830 EXAMINER FOSTER, CHRISTINE E ART UNIT PAPER NUMBER 1641 MAIL DATE DELIVERY MODE 03/01/2011 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ALEXANDER BELENKY, LAURIE ANN LIVSHIN, and MINAS BARBARAKIS __________ Appeal 2010-007512 Application 11/089,261 Technology Center 1600 __________ Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and JEFFREY N. FREDMAN, and Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134 involving claims to a reagent composition. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-007512 Application 11/089,261 2 STATEMENT OF THE CASE Claims 5 and 21 are on appeal (App. Br. 3).2 The claims have not been argued separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). We will focus on claim 21, the only independent claim on appeal, which reads as follows: 21. An automated immunoanalyzer reagent composition adapted to extract cyclosporine analyte from a heterogeneous biological test sample selected from the group consisting of serum, plasma, whole blood, urine, and spinal fluid; in the absence of an organic solvent, in the absence of a precipitating agent, and without separation of the cyclosporine from the test sample, comprising an aqueous solution of: (a) about 0.25 weight % to about 0.5 weight % of a zwitterionic detergent selected from the group consisting of: 3-[N, N-dimethyl(3-myristoylaminopropyl)ammonio]-propanesulfate, 3-(4-heptyl)phenyl 3-hydroxy propyl)dimethylammonio propane sulfate, 3-(decyldimethylammonio)propanesulfonate inner salt, 3-(N, N-dimethylmyristylammonio)propanesulfonate, 3-(N, N-dimethyloctadecylammonio)propanesulfonate, 3-(N, N-dimethyloctylammonio)propanesulfonate inner salt, 3-(N, N-dimethylpalmitylammonio)propanesulfonate, and 3-(dodecyldimethylammonio)propanesulfonate inner salt; (b) about 0.25 weight % to about 0.5 weight % of saponin; and (c) about 5 weight % to about 50 weight % of a viscosity additive selected from the group consisting of glycerin and sucrose. 2 Claims 11-20 are also pending but have been withdrawn from consideration (App. Br. 3). Appeal 2010-007512 Application 11/089,261 3 Claims 5 and 21 stand rejected under 35 U.S.C. § 103(a) as obvious over Zeggari3 in view of VandenBerg,4 Anilionis,5 or Schneider6 in light of Sigma-Aldrich,7 EMD Biosciences,8 and Pitha9 (Ans. 5-6). Claims 5 and 21 stand rejected under 35 U.S.C. § 103(a) as obvious over Tajima10 in view of Hoiseth11 and Fang12 in light of Sigma-Aldrich 213 and Pitha (Ans. 9). I With regard to the obviousness rejection of claims 5 and 21 over Zeggari in view of various references, we affirm this rejection for the reasons set forth in the Examiner’s Answer. In particular, we conclude that the Examiner has set forth a prima facie case that Zeggari, as combined with other applied references, suggests a composition that is capable of being used according to the recited intended use. See In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969) (“[M]ere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition 3 Zeggari et al., Solubilization and characterization of guinea-pig pancreatic somatostatin receptors, 164 EUR. J. BIOCHEM. 667-673 (1987). 4 VandenBerg et al., Solubilization and characterization of high-affinity [3H]serotonin binding sites from bovine cortical membranes, 80 PROC. NATL. ACAD. SCI. USA 3508-3512 (1983). 5 Anilionis et al., US 5,098,997, Mar. 24, 1992. 6 Schneider et al., US 2007/0157326 A1, Jul. 5, 2007. 7 Sigma-Aldrich, product information for T7763. 8 EMD Biosciences, product information for Zwittergent® 3-14 Detergent. 9 Pitha, US 4,546,097, Oct. 8, 1985. 10 Tajima et al., US 7,045,593 B2, May 16, 2006. 11 Hoiseth et al., WO 2005/065708 A2, Jul. 21, 2005. 12 Fang et al., US 2005/0048648 A1, Mar. 3, 2005. 13 Sigma-Aldrich, product information for D4516. Appeal 2010-007512 Application 11/089,261 4 patentable.”). In addition, we agree with the Examiner that Appellants have not provided sufficient evidence that the claimed composition provides unexpectedly superior properties as compared to the closest prior art. II With regard to the obviousness rejection over Tajima in view of Fang, as well as other references, the Examiner relies on Tajima for teaching “a reagent (‘cell-free protein synthesis system’) comprising a mild detergent in aqueous solution” and that “suitable detergents can be used as a single species, or as a combination” (Ans. 10). The Examiner relies on Pitha and Sigma-Aldrich 2 for providing evidence that one of Tajima’s detergents, digitonin, is a saponin and that another of Tajima’s detergents, N,N-dimethyldodecylammonio propanesulfonate, is one of the claimed zwitterionic detergents, 3-(dodecyldimethylammonio)propanesulfonate (id.). Regarding the amounts of detergents, the Examiner finds that Tajima “teaches digitonin in amounts of 0.1-2%” (id. at 11). In addition, the Examiner finds that Tajima generally “directs the skilled artisan to employ amounts that are preferably 3 to 10 times the CMC of the detergent” (id.). The Examiner relies on Hoiseth for teaching that the “CMC of 3-(dodecyl- dimethylammonio)propanesulfonate . . . was known in the prior art to be 0.047%-0.13%” (id.). The Examiner concludes that “it would have been further obvious when including 3-(dodecyldimethylammonio)propane- sulfonate to employ this detergent in the claimed amounts because using 3 to 10 times the CMC as directed by Tajima . . . would give amounts of 0.14%- 1.3%” (id.). Appeal 2010-007512 Application 11/089,261 5 The Examiner relies on Fang for teaching “membrane stabilizers that can be used to stabilize arrays of membrane proteins [0045]” (Ans. 13). In particular, the Examiner finds that Fang teaches “that about 10% glycerol (glycerin) can be added in order to enhance the stability of membrane- embedded receptor arrays” (id.). The Examiner concludes that “it would have been further obvious to include glycerol in amounts falling within the claimed range in the reagent of Tajima . . . and Hoiseth . . . because Fang . . . taught that glycerol also acts to stabilize membrane proteins, which is the same purpose for which the reagent of Tajima . . . is used” (id.). Appellants argue that “the combination of Fang with [Tajima and Hoiseth] would result in a collection of disparate teachings, without any unifying theme, that would not collectively suggest Applicants’ claimed invention in an obvious manner” (App. Br. 10). Issue Has the Examiner set forth a prima facie case that it would have been obvious, based on the disclosures in Fang, to include glycerol (or sucrose) in a composition according to Tajima that comprises the claimed amounts of a zwitterionic detergent and a saponin? Findings of Fact 1. Tajima discloses a “method for producing a protein using a cell-free protein synthesis system comprising a detergent so that the protein can be synthesized without aggregation” (Tajima, Abstract). 2. Tajima also discloses that the “protein is a protein comprising a hydrophobic region in at least a portion thereof, for example, a membrane protein or its fragment” (id.). Appeal 2010-007512 Application 11/089,261 6 3. In addition, Tajima discloses that the “synthesized protein is found to have biological functions with great probability, even though it is not in the native states in vivo, such as a membrane bound state” (id. at col. 2, ll. 25-27). 4. Tajima also discloses: “It is further preferable to reconstitute the protein synthesized in the cell-free protein synthesis system with artificial membranes, liposomes or the like. . . . The synthesized protein is reconstituted in a lipid membrane by decreasing the concentration of detergent . . . in a cell-free protein synthesis system supplemented with the detergent and lipid.” (Id. at col. 7, ll. 58-67.) 5. Fang discloses a “buffered solution or ‘ink’ composition for re- formulating or suspending biological membranes used in the fabrication of membrane arrays,” the composition comprising “at least two of the following six classes of reagents: 1) a pH buffer reagent; 2) a monovalent or divalent, inorganic salt; 3) a membrane stabilizer; 4) a solution viscosity control reagent; 5) a water-soluble protein; or, 6) a protease inhibitor” (Fang, Abstract). 6. Fang also discloses: The membrane stabilizer is preferably either trehalose or sucrose. Glycerol or the like also can be included so as to achieve better viscosity in the receptor solution for sample pick- up and deposition by a pin. . . . Most preferably, the receptor membrane preparations are re-suspended in a buffer containing: 50 m/M Tris-HCl, pH 7.4, 10 mM MgCl2, 0.5% BSA, ~10% trehalose or sucrose, and ~10% glycerol. (Id. at ¶ [0045].) Appeal 2010-007512 Application 11/089,261 7 Principles of Law A claim “composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The relevant question is “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. Analysis Tajima discloses a composition comprising a detergent that can be used for synthesizing a membrane protein (Findings of Fact (FF) 1-2). Fang discloses a “buffered solution or ‘ink’ composition for re-formulating or suspending biological membranes” (FF 5). Fang discloses adding glycerol “to achieve better viscosity” (FF 6). However, the Examiner has not adequately explained why one of ordinary skill in the art would have added a viscosity additive to Tajima’s detergent composition. Fang also discloses adding sucrose as a membrane stabilizer (FF 6). However, the Examiner has not adequately explained why one of ordinary skill in the art would have added a membrane stabilizer to Tajima’s detergent composition. The Examiner finds that, “as both Tajima et al. and Fang are directed to the problems of stabilizing hydrophobic analytes (and specifically, membrane proteins), . . . the prior art inventions do share in common this unifying theme” (Ans. 26). However, whereas Tajima teaches using its detergent composition in the synthesis of a membrane protein that is not membrane bound (FF 1-3), Fang discloses including sucrose to stabilize the membrane itself (FF 6). Therefore, we do not agree with the Appeal 2010-007512 Application 11/089,261 8 Examiner’s conclusion that the detergents of Tajima and the membrane stabilizers of Fang are directed to the same purpose. In addition, although Tajima does disclose reconstituting the synthesized protein with a membrane (FF 4), the Examiner has not shown that it would have been obvious to include the claimed amounts of detergents during the reconstitution. Conclusion The Examiner has not set forth a prima facie case that it would have been obvious, based on the disclosures in Fang, to include glycerol (or sucrose) in a composition according to Tajima that comprises the claimed amounts of a zwitterionic detergent and a saponin. We therefore reverse the obviousness rejection of claims 5 and 21 over Tajima in view of Fang, as well as other references. 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). AFFIRMED cdc SIEMENS CORPORATION INTELLECTUAL PROPERTY DEPARTMENT 170 WOOD AVENUE SOUTH ISELIN, NJ 08830 Copy with citationCopy as parenthetical citation