Ex Parte Stray et al

Patent Trial and Appeal BoardMar 7, 2016

12882194 (P.T.A.B. Mar. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/882, 194 09/14/2010 52059 7590 03/09/2016 LIFE TECHNOLOGIES CORPORATION Attn: IP Department 5823 Newton Drive Carlsbad, CA 92008 FIRST NAMED INVENTOR James Stray 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. LT00060 2481 EXAMINER DAUNER, JOSEPH G ART UNIT PAPER NUMBER 1634 NOTIFICATION DATE DELIVERY MODE 03/09/2016 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): LifetechDocket@system.foundationip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES STRAY, JASON YINGJIE LIU, MAXIM BREVNOV, JAIPRAKASH SHEW ALE, and ALLISON HOL T1 Appeal2014-001388 Application 12/882, 194 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to lysis buffer solutions used in connection with DNA extraction, which have been rejected as anticipated. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Life Technologies Corp. Br. 3. Appeal2014-001388 Application 12/882, 194 STATEMENT OF THE CASE As stated in the Specification, the present invention relates to "the extraction of nucleic acid from solid materials such as bone, tooth and calcified tissues, or biological samples embedded or adherent to adhesive materials or denim materials." c,-i 2.) The extraction of nucleic acid from solid biological materials such as calcified bone and tooth, or biological samples containing nucleic acids embedded and/or adherent to adhesive and gum-containing materials as well as biological materials on dried or embedded in denim materials presents sample processing challenges and potential delays in sample processing in the forensic laboratory. (,-i 3.) The Specification states that the disclosed invention provides "useful compositions and methods for obtaining nucleic acids, such as genomic DNA and RNA, from a solid biological sample, an adhesive material having a biological material adherent or embedded \"1ithin the adhesive substrate or a denim materials or soil." (Id.) Claims 1 and 101 are on appeal. Claim 1 is illustrative and reads as follows: 1. A composition comprising each of the following: a detergent, a chelating agent, a reducing agent, and an enzyme, wherein the detergent is selected from one or more of-N-lauroyl sarcosine, sodium deoxycholate, cetyltrimethylammonium bromide, dodecyl B-D-maltoside, nonanoyl-N- methylglucamide, polyethylene glycol p-(1, 1,3,3-tetramethylbutyl)-phenyl ether, sodium dodecyl sulfate, and combinations thereof, wherein the chelating agent comprises one or more of ethylene glycol tetraacetic acid, and citric acid and combinations thereof, wherein the reducing agent comprises one or more of tris(2-carboxyethyl)phosphine, dithioerythritol, and dithiothreitol, and wherein the enzyme is selected from caspase, chymotrypsin, pepsin, proteinase K, thombin, Staphylococcus V8 protease, 2 Appeal2014-001388 Application 12/882, 194 pronase, papain, Bacillus sp. ElA protease, and trypsin and combinations thereof. The claims stand rejected as follows: Claims 1and101 stand rejected under 35 U.S.C. Â§ 102(b) as being anticipated by Bille (US 2003/0215845 Al, published Nov. 20, 2003). DISCUSSION Issue The Examiner has rejected claims 1 and 101 as anticipated. The Examiner finds that "Bille discloses in three separate instances a lysis buffer or 'composition' that is a combination of reagents that includes EGTA [chelating agent], proteinase K [enzyme], N-lauroyl-sarcosine [detergent] and DTT [ dithiothreitol, reducing agent] as encompassed by claims 1 and 101 in accordance with their broadest reasonable interpretation" (Ans. 4). Appellants contend that Bille does not "clearly and unequivocally disclose[]" the combination recited in the claims nor does Bille provide specific direction that would lead one skilled in the art to the claimed compositions. (Br. 10.) The issue presented is whether the Examiner has established that Bille anticipates the claimed composition within the meaning ofÂ§ 102. Findings of Fact FFl. The Examiner rejects claims 1 and 101 under 35 U.S.C. Â§ 102(b) as anticipated by Bille. (Ans. 4.) 3 Appeal2014-001388 Application 12/882, 194 FF2. The Examiner finds that Bille discloses a lysis buffer that includes EGTA, proteinase K, N-lauroyl-sarcosine and DTT, a chelating agent, an enzyme, a detergent and reducing agent respectively. (Ans. 4.) FF3. Bille related to selective lysis of cells to allow extraction of DNA from the cells. (iJ 2.) FF4. Bille discloses a lysis buffer for extracting DNA from cells that comprises a reagent or combination of reagents selected from Tris-HCl, NaCl, Na2EDTA, EGTA, SDS (sodium dodecyl sulfate), proteinase, proteinase K, TNE, N-lauroyl-sarcosine, sarkosyl, Triton, sodium pyrophosphate, glycerophosphate, leupeptin, DTT, EGTA, MgCL2, KCl, NaF, sodium valdalate, sodium molybdate, B-glycerophosphate, RIPA buffer (1 % NP- 40, Triton X-100, 1 % sodium deoxycholate, 0.1 % SDS, 0.15 molar NaCl, 0.01 molar sodium phosphate, pH 7.2, 1 % Trasylol) without EDTA, NP40 buffer (1 % NP-40 or Triton X- 100, 0.15 molar NaCl, 0.01 molar sodium phosphate (pH 7.2), 1 % Trasylol), guanidine, guanine thiocyanate or certain other chaotropic agents and detergents, ionic detergents, bile acid salts, nonionic detergents, zwitterionic detergents, alkaline lysis extraction (1 M NaCl, 1 N NaOH and/or 0.1 % SDS), TWEEN 20 or a mixture of SDS or sarkosyl and Proteinase K with or without DTT. (iJ 119.) Principles of Law To anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim. Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). "[R]ejections under 35 U.S.C. Â§ 102 are proper only when the 4 Appeal2014-001388 Application 12/882, 194 claimed subject matter is identically disclosed or described in 'the prior art."' In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Thus, an anticipatory reference under 35 U.S.C. Â§ 102 "must clearly and unequivocally disclose the claimed [subject matter] or direct those skilled in the art to the [claimed subject matter] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference." Id. We recognize, however, that a generic disclosure may anticipate a claim to a species within the generic disclosure. E.g., In re Schaumann, 572 F.2d 312 (CCPA 1978). The test for anticipation "is not an 'ipsissimis verbis' test." In re Bond, 910 F.2d 831, 832 (Fed. Cir. 1990). Analysis Appellants argue that Bille does not clearly and unequivocally disclose what is claimed, namely a four component lysis buffer containing a detergent, a chelating agent, a reducing agent, and an enzyme. (Br. 10.) Appellants further argue that Bille fails to provide specific direction that would lead the skilled artisan to the claimed compositions. (Id.) We agree with the Appellants' arguments set forth above. While "[s]uch picking and choosing may be entirely proper in the making of a 103, obviousness rejection ... it has no place in the making of a 102, anticipation rejection." Arkley, 455 F.2d at 587-588. We agree that the reference need not literally disclose one single embodiment meeting all the claimed elements. In this case, however, Bille discloses a lysis buffer that may comprise a single reagent or a combination of reagents selected from a listing of over thirty possible reagents. Bille, however, does not direct one to a composition comprising the particular subset of elements required by 5 Appeal2014-001388 Application 12/882, 194 either claim 1 or claim 101. Thus, we conclude that there is nothing specifically directing the ordinary artisan to the specific claimed composition so as to render it anticipated by Bille. Conclusion of Law We conclude that the Examiner has not established that Bille anticipates the claimed composition within the meaning ofÂ§ 102. SUMMARY We reverse the rejection of claims 1and101under35 U.S.C Â§ 102(b) as anticipated by Bille. REVERSED 6