Ex Parte Sharma et alDownload PDFPatent Trial and Appeal BoardApr 26, 201310727576 (P.T.A.B. Apr. 26, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte PRAVEEN SHARMA and ANDERS LONNEBORG __________ Appeal 2011-009764 Application 10/727,576 Technology Center 1600 __________ Before FRANCISCO C. PRATS, ERICA A. FRANKLIN, and JOHN G. NEW, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a process of obtaining mRNA or cDNA species useful for diagnosing or identifying breast cancer. The Examiner entered rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 18-35 stand rejected and appealed (App. Br. 4). Claim 18 is representative and reads as follows: Appeal 2011-009764 Application 10/727,576 2 18. A method of obtaining isolated selected mRNA species or isolated selected cDNA species useful for diagnosing or identifying breast cancer in a human comprising the steps of: (a) isolating mRNA from cells from blood of more than one human who are known to have very early stage breast cancer (breast cancer sample), wherein the resulting isolated mRNA is optionally subjected to reverse transcription to obtain isolated cDNA; (b) isolating mRNA from corresponding cells from blood of more than one normal human (normal sample), wherein the resulting isolated mRNA is optionally subjected to reverse transcription to obtain isolated cDNA; (c) separating mRNA species or cDNA species present within each of the resulting isolated mRNA or isolated cDNA of step (a) and step (b), wherein the resulting separated mRNA species are optionally subject to reverse transcription to obtain separated cDNA species; (d) selecting 10 or more mRNA species or 10 or more cDNA species from the resulting separated mRNA species or resulting separated cDNA species obtained in step (c), respectively, which are present at a different level in the normal sample than in the breast cancer sample by identifying a signal corresponding to each mRNA species or cDNA species, wherein the resulting selected 10 or more mRNA species are optionally subjected to reverse transcription to obtain 10 or more selected cDNA species; and (e) isolating the resulting 10 or more selected mRNA species or resulting 10 or more selected cDNA species obtained in step (d) to obtain isolated selected mRNA species or isolated selected cDNA species, wherein the resulting isolated selected mRNA species are optionally subjected to reverse transcription to obtain isolated selected cDNA species. The following rejections are before us for review: (1) Claims 18 and 20-25, under 35 U.S.C. § 103(a) as obvious over Ralph 1 and Lukas 2 (Ans. 4-6); and 1 U.S. Patent No. 6,190,857 B1 (filed March 24, 1998). Appeal 2011-009764 Application 10/727,576 3 (2) Claims 19, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35, under 35 U.S.C. § 103(a) as obvious over Ralph, Lukas, and Wadhwa 3 (Ans. 6-8). DISCUSSION As Appellants do not argue any of the claims subject to rejection (1) over Ralph and Lukas separately, we select claim 18 as representative of the claims subject to that rejection. See 37 C.F.R. § 41.37(c)(1)(vii). We have carefully considered the Examiner’s position. We have also carefully considered all of Appellants’ arguments, the Examiner’s rebuttal, and the evidence of record, including the Declaration of inventor Dr. Praveen Sharma under 37 C.F.R. § 1.132 (see App. Br., Evidence Appendix (Declaration entered September 21, 2007)), as well as the first and second Declarations under 37 C.F.R. § 1.132 of Dr. James Mackay (see id. (Declarations entered March 27, 2009, and December 1, 2009)). We affirm the Examiner’s rejection of claim 18 as obvious over Ralph and Lukas for the reasons set forth in the Examiner’s Answer. As they were not argued separately, claims 20-25 fall with claim 18. See 37 C.F.R. § 41.37(c)(1)(vii). As to rejection (2), Appellants argue that “Wadhwa does not cure the deficiencies of Ralph and Lukas discussed above, and does nothing further to render the claimed invention obvious, because Wadhwa is merely relied 2 J.J. Lukas, Identification and Characterization of Genes Differentially Expressed in Breast Ductal Carcinoma In Situ, 45 JOURNAL OF INVESTIGATIVE MEDICINE 132A (1997). 3 Renu Wadhwa et al., An Effective Elimination of False Positives Isolated from Differential Display of mRNAs, 6 MOLECULAR BIOTECHNOLOGY 213- 217 (1996). Appeal 2011-009764 Application 10/727,576 4 upon for teaching a technical assay, i.e., reverse Northern assay of DNA fragments isolated from differential display” (App. Br. 24). As noted above, however, we are not persuaded, for the reasons set forth in the Examiner’s Answer, that the Examiner’s ultimate conclusion of obviousness in view of Ralph and Lukas is erroneous. Thus, as Appellants identify no error in the Examiner’s conclusion of obviousness as to claims 19, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35, and as we detect none, we affirm the Examiner’s rejection of those claims as well. SUMMARY We affirm the Examiner’s obviousness rejection of claims 18 and 20- 25 over Ralph and Lukas. We also affirm the Examiner’s obviousness rejection of claims 19, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 over Ralph, Lukas, and Wadhwa. 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 cdc Copy with citationCopy as parenthetical citation