Ex Parte BrennerDownload PDFPatent Trial and Appeal BoardOct 29, 201211377462 (P.T.A.B. Oct. 29, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte SYDNEY BRENNER __________ Appeal 2011-012114 Application 11/377,462 Technology Center 1600 __________ Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and STEPHEN WALSH, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2011-012114 Application 11/377,462 2 STATEMENT OF THE CASE “The invention provides methods and compositions for labeling polynucleotides and for providing multiplex readouts from assays on polynucleotides. In one aspect, the invention provides compositions of oligonucleotide tags that have properties favorable for labeling polynucleotides and for permitting readouts on various analytical platforms, such as microarrays and DNA separation instruments, such as electrophoresis devices.” (Spec. 2.) “Preferably, sizes of fragments in fragment sets are selected so that distinguishable bands or peaks are formed for each metric tag in a separation profile after separation” (Spec. 14), including separation by electrophoresis. The following claim is representative and reads as follows: 13. A method of determining the number of copies of a polynucleotide in a sample, the method comprising the steps of: attaching to each copy of the polynucleotide in the sample a different nucleotide tag to form tag-polynucleotide conjugates, wherein each different nucleotide tag has a unique nucleotide sequence; attaching to each of said tag-polynucleotide conjugates a different metric tag to form metric tag-polynucleotide conjugates, wherein each different metric tag has a unique nucleotide length and each metric tag has a one-to-one correspondence with a different nucleotide tag; cleaving the attached metric tags from said metric tag-polynucleotide conjugates to generate cleaved metric tags; separating and detecting said cleaved metric tags by electrophoretically driven size separation; and counting the number of different cleaved metric tags to determine the number of copies of said polynucleotide in said sample. Cited References The Examiner relies on the following prior art references: Matray et al. US 2003/0207300 A1 Nov. 6, 2003 Appeal 2011-012114 Application 11/377,462 3 Mao et al. WO 02/097113 A2 Dec. 5, 2002 Sorge US 2003/0050453 A1 Mar. 13, 2003 Moore et al., Isolation and Purification of Large DNA Restriction Fragments from Agarose Gels, Current Protocols in Molecular Biology, 2.6.1-2.6.12 (2002). Grounds of Rejection Claims 7, 9-10, 13 and 22-23 are rejected under 35 U.S.C. §103(a) as being unpatentable over Matray in view of Mao and Sorge. Claims 24 and 25 are rejected under 35 U.S.C. §103(a) as being unpatentable over Matray in view of Mao, Sorge and Moore. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 5- 10. Discussion Claims 7, 9-10, 13 and 22-23 are rejected under 35 U.S.C. §103(a) as being unpatentable over Matray in view of Mao and Sorge. Appellants provide separate argument for claim 13 (Br. 5.), which we select as representative claim. ISSUE The Examiner concludes that it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to improve the method of Matray for detecting the abundance of a polynucleotide to include the use of cleavable tags with unique nucleic acid sequence tags of Mao and the unique length segments of Sorge that encode the sequence of Appeal 2011-012114 Application 11/377,462 4 the nucleic acid tag of Mao. The combined teachings of Matray, Mao and Sorge demonstrate all the elements of the known invention were known and used in the detection of nucleic acids in a population by use of a tag. The artisan would merely be providing the specific unique tagging method of Mao and encoding the unique tag of Mao by the methods of encoding polynucleotide sequences by length taught by Sorge for the general teaching of Matray to result in a method for quantitating the number of nucleic acids in the sample. The artisan would be motivated so as to be able to detect the amount of a nucleic acid as suggested by Matray. The artisan would have a reasonable expectation of success as the artisan is substituting the specific unique nucleic acid tags of Mao into the nucleic acids being labeled with length based codes as taught by Sorge in the method of detecting nucleic acid abundance by the use of cleavable tags taught by Matray. (Ans. 8-9.) Appellant principally argues, among other things, that 1) “Mao et al. teaches that each differently sized fragment in a size ladder has the same tag attached.” (App. Br. 7.) “Appellants submit that Mao et al. does not teach that fragments of a different size have a different tag attached (i.e., a tag of a different sequence).” (Id. at 8.) 2) The teachings of Mao et al., when considered in full, fail to teach “attaching to each of said tag-polynucleotide conjugates a different metric tag to form metric tag-polynucleotide conjugates, wherein each different metric tag has a unique nucleotide length and each metric tag has a one-to-one correspondence with a different nucleotide tag” as claimed. (Id. at 9.) 3) “Sorge et al. teaches that the same tag is attached to polynucleotides having the same sequence (similar to the size ladders in Mao et al.), which is in direct contrast to the claimed invention in which a different tag is attached to each copy of a polynucleotide in a sample.” (Id. at 10.) Appeal 2011-012114 Application 11/377,462 5 The issue is: Has the Examiner established with evidence and reasoning that the pending claims are obvious in view of the cited references? PRINCIPLES OF LAW “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). ANALYSIS We agree with the Examiner’s fact finding, statement of the rejection and responses to Appellant’s arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. We provide the following additional comment. The Examiner provided a thorough response to Appellant’s arguments in the Answer at pages 10-22, which we adopt as our own. More Appeal 2011-012114 Application 11/377,462 6 specifically, the Examiner addresses Appellant’s argument 1) on page 11 of the Answer, the Examiner addresses Appellant’s argument 2) on page 12-13 of the Answer, and the Examiner addresses Appellant’s argument 3) on page 11 of the Answer pages 14-15. Appellant presents similar arguments for the rejection of claims 24-25 as presented in the original obviousness rejection. The rejection of these claims is also affirmed for the reasons given by the Examiner in the Answer. We note that while Appellant’s Specification and figures provide a detailed method of determining the number of copies of a polynucleotide in a sample which are not claimed and which may include novel features not found in the prior art, the pending claim scope is broad and remains obvious in view of the cited prior art. CONCLUSION OF LAW The cited references support the Examiner’s obviousness rejection. TIME PERIOD 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 alw Copy with citationCopy as parenthetical citation