Ex Parte Kleiber et alDownload PDFPatent Trial and Appeal BoardJul 26, 201613269195 (P.T.A.B. Jul. 26, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/269, 195 10/07/2011 Jorg Kleiber 22829 7590 07/28/2016 Roche Molecular Systems, Inc, 4300 Hacienda Drive Pleasanton, CA 94588 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. 18242-US6 4540 EXAMINER HUMPHREY, LOUISE WANG ZHIYING ART UNIT PAPER NUMBER 1657 NOTIFICATION DATE DELIVERY MODE 07/28/2016 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): misty.prasad@roche.com pair_roche@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte JORG KLEIBER, THOMAS WALTER, HERBERT HARTTIG, CHRISTOPH LESNIAK, MARTIN MENNIG, MICHAEL RIEDLING, and HELMUT SCHMIDT1 Appeal2014-005661 Application 13/269,195 Technology Center 1600 Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for separating nucleic acids from a fluid. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 According to Appellants, the real party in interest is ROCHE MOLECULAR SYSTEMS, INC. (Br. 5.) Appeal2014-005661 Application 13/269,195 STATEMENT OF THE CASE Claims on Appeal Claims 13-18 are on appeal. (Claims Appendix, Br. 22-23.) Claim 13 is illustrative and reads as follows: 13. A method for separating nucleic acids from a fluid containing the nucleic acids comprising: a) bringing a sample that contains the nucleic acids in a fluid in contact with a magnetic particle, the magnetic particle comprising a magnetic core and an outer glass layer, said outer glass layer completely covers the magnetic core and does not contain boron oxide; and has an outer glass surface, under conditions such that the nucleic acids bind to the glass surface; and thereafter b) separating the bound nucleic acids from the fluid. Examiner Rejections 1. Claims 13-18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Hawkins,2 Groves, 3 and Padhye,4 and if necessary5 in further view of Woodard,6 Falleroni,7 Palladino,8 or Whitehead. 9 (Final Act. 2.) 10 2. Claims 13-18 stand rejected on the ground of nonstatutory obviousness-type double patenting over claims 1-27 of U.S. Patent No. 2 Hawkins, US 5,898,071, issued Apr. 27, 1999 ("Hawkins"). 3 Groves et al., EP 0343934 A2, published Nov. 29, 1989 ("Groves"). 4 Padhye et al., US 5,658,548, issued Aug. 19, 1997 ("Padhye"). 5 The subsequent references are not at issue in the instant appeal, and are identified herein only for the sake of completeness. 6 Woodard et al., US 5,503,816, issued Apr. 2, 1996. 7 Falleroni et al., US 4,824,712, issued Apr. 25, 1989. 8 Palladino, US 5,458,813, issued Oct. 17, 1995. 9 Whitehead et al., 4,698,302, issued Oct. 6, 1987. 10 Office Action dated May 21, 2013. 2 Appeal2014-005661 Application 13/269,195 6,562,568, or claims 1---6 of U.S. Patent No. 6,870,047, or claims 1-11 of U.S. Patent No. 6,255,477, or claims 1--4 of U.S. Patent No. 7,371,830, in view of Groves and Padhye. 11 (Id. at 8.) With respect to Rejection No. 1, Appellants argue claims 13-18 as a group. Accordingly, we limit our consideration of that rejection to claim 13. FINDINGS OF FACT We adopt as our own the Examiner's findings and analysis concerning the scope and content of the prior art. The following findings are included for emphasis and reference convenience. FF 1. The Examiner finds that Hawkins discloses DNA purification and isolation, from a solution containing DNA, using magnetic microparticles having a metal oxide core and a silane coating. (Final Act. 3, citing Hawkins col. 1, 1. 30-col. 2, 1. 17; col. 3, 11. 1-15.) FF 2. The Examiner finds that Groves discloses magnetic particles having a core of magnetic material encapsulated in a metal oxide coating. The metal oxide may include "biocompatible glasses," and provide "reactive sites for binding to molecules of biological interest." The magnetic particles can be used for separations. (Id., citing Groves col. 1, 1. 54; col. 4, 11. 13, 29-35.) FF 3. The Examiner finds that Padhye discloses the use of silica materials, such as glass particles, to separate DNA from other substances. (Id. at 4, citing Padhye col. 2, 11. 61---68.) 11 No additional information is provided herein regarding these patents because Appellants do not argue Rejection No. 2. 3 Appeal2014-005661 Application 13/269,195 DISCUSSION Issue Whether a preponderance of evidence of record supports the Examiner's conclusion of obviousness under 35 U.S.C. § 103(a). Analysis Rejection No. I-Obviousness The Examiner concluded that it would have been obvious "to substitute a glass coating for the silane coating on the magnetic microparticles" taught by Hawkins. (Ans. 5.) Furthermore, the glass coating would "bind and separate nucleic acids from a solution," as suggested by Groves, and as further suggested by Padhye' s teaching of using glass particles for DNA separation. (Id.) Moreover, according to the Examiner, "[g]lass coated magnetic particles would have been an obvious alternative to the silane coated magnetic particles of Hawkins." (Id.) We find that the Examiner has satisfied the burden of showing "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, the Examiner has established a prima facie case of obviousness and, as discussed below, Appellants have not overcome that prima facie case. Combination of References Appellants acknowledge that "Hawkins teaches isolating nucleic acids using microparticles with a metal oxide core and a silane coating" and that Padhye "teaches using glass powder to isolate nucleic acids." (Br. 14.) However, Appellants argue that, in analyzing Groves, "the examiner put incorrect emphasis on the fact that magnetic particles are encapsulated in a 4 Appeal2014-005661 Application 13/269,195 metal oxide coating that can be Si02 (i.e., glass like)." (Id. at 14-15.) As a result, according to Appellants, "the combination of glass and magnetic particles to isolate nucleic acids, is not found in the prior art." (Id. at 15.) We are not persuaded. The test for obviousness is what the combined teachings of Hawkins, Groves, and Padhye would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases). Here, we agree with the Examiner that it would have been obvious to coat the magnetic particles of Hawkins with the glass coating of Groves because Padhye teaches using glass particles for DNA separation. (FF 1-3.) Reasonable Expectation of Success Appellants argue that a person of ordinary skill in the art would not have had any expectation of success in replacing the silane coating of Hawkins with glass. (Br. 15-16.) In support of that argument, Appellants point to Padhye' s statement that contaminants bind "with some tenacity" to glass, requiring "at least four separate washes before nucleic acids can be eluted." (Id. at 16, citing Padhye col. 8, 1. 24-col. 9, 1. 29.) Appellants also point to the Walter Declaration, 12 discussed further below, for the proposition that the combination of magnetic particles and glass was thought to be unworkable. (Id.) We are not persuaded. The reasonable expectation of success requirement "refers to the likelihood of success in combining references to meet the limitations of the claimed invention." Intelligent Bio-Systems, Inc. 12 Declaration Submitted with Response to an Office Action, by Thomas Walter, dated Mar. 1, 2013 ("Walter Declaration"). 5 Appeal2014-005661 Application 13/269,195 v. lllumina Cambridge Ltd., 821F.3d1359, 1367 (Fed. Cir. 2016). Here, claim 13 does not exclude the possibility of multiple washes to remove contaminants (if any). Furthermore, Groves teaches magnetic particles, having a coating that may include glasses (FF 2), that are "suitable for use in biological separations." (Groves, col. 1, 11. 4--5.) Moreover, the unsupported Walter Declaration does not overcome the reasonable expectation of success evidenced by the prior art (e.g. Groves), or provide any basis for concluding that overcoming any purported challenges in combining magnetic particles and glass would not have been within the skill of an ordinary artisan. See KSR, 550 U.S. at 421 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton."); In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (skill is presumed on the part of one of ordinary skill in the art). Hindsight Appellants argue that "[t]he teachings of Padhye regarding impurities tightly bound to glass would be of concern to a person of ordinary skill contemplating adding glass coating to magnetic particles" and that "the examiner dismissed this concern by simply stating that ' [ t ]he glass coating would have been expected to bind and separate nucleic acids as desired by Hawkins, and provide the function of glass for nucleic acid purification as disclosed by Padhye. '" (Br. 16-17, quoting Final Act. 5---6, emphasis Appellants'.) According to Appellants, " [ s ]uch certainty [by the Examiner] in the success of the method is possible only in hindsight." (Id. at 17.) We are not persuaded. The sentence immediately preceding the one quoted by Appellants specifically refers to Groves and Padhye as "disclosing glass binding biological material and nucleic acids" and states that "it would 6 Appeal2014-005661 Application 13/269,195 have been obvious [that] a glass coating on the magnetic microparticles of Hawkins will provide the function of the silane coating." (Final Act. 5.) Accordingly, rather than using hindsight, the Examiner points to specific disclosures in the prior art that describe the limitations of Appellants' claimed method. (Id. at 2-7.) Declaration Appellants argue that the Walter Declaration was not given adequate weight by the Examiner, apparently because if it had been given adequate weight, the obviousness rejection would have been rebutted. (Br. 17-21.) Appellants also argue specific "anticipated difficulties" raised in the Walter Declaration, and conclude by stating "[t]he correct inquiry would have asked whether the alleged combination could have been made despite the concern for the problems set forth in Padhye and the Declaration." (Id. at 20-21.) We are not persuaded. We note that the Examiner addressed the Walter Declaration and the issues raised therein. (Final Act. 6-7.) Moreover, the Examiner addressed the unsupported contentions in the Walter Declaration by referencing the teachings of the prior art. (Id.) Accordingly, we agree with the Examiner that the Walter Declaration does not rebut the prima facie case of obviousness and, in particular, we are not persuaded by Appellants' argument that the Examiner did not give the Walter Declaration adequate weight. Appellants also argue that the Walter Declaration supports the position that magnetic particles and glass "were believed to be incompatible during isolation of nucleic acids." (Br. 18.) Specifically, Appellants point to paragraphs 7 and 8 of the Walter Declaration as support for the belief that multiple washes of the particles would be necessary, that the presence of the 7 Appeal2014-005661 Application 13/269,195 magnetic core would make the washes ineffective, and that "chaotropic salts necessary for binding of nucleic acids to glass would be especially difficult to get rid of ... and detrimental to subsequent uses of the isolated nucleic acids." (Id. at 18-19.) We find that these unsupported contentions (e.g., the need for multiple washes or "subsequent uses" of the nucleic acids) are not pertinent to the claim limitations or, at most, the type of concerns or problems that a person of ordinary skill would have had sufficient skill to address. See Sovish, 769 F.2d at 743. Conclusion of Law A preponderance of evidence of record supports the Examiner's conclusion that claim 13 is obvious under 35 U.S.C. § 103(a). Claims 14--18 were not argued separately and fall with claim 13. Rejection No. 2-0bviousness-type Double Patenting Appellants present no arguments in response to Rejection No. 2. Accordingly, Rejection No. 2 is affirmed. See 37 C.F.R. § 41.37(c)(l)(iv); Hyattv. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008). SUMMARY We affirm the rejections of all claims on appeal. 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 8 Copy with citationCopy as parenthetical citation