Ex Parte Rabbani et alDownload PDFPatent Trial and Appeal BoardJun 27, 201612004842 (P.T.A.B. Jun. 27, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/004,842 12/20/2007 28171 7590 06/28/2016 ENZO BIOCHEM, INC Donna M. Tirella 527 MADISON A VENUE (9TH FLOOR) NEW YORK, NY 10022 FIRST NAMED INVENTOR Elazar Rabbani 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. ENZ-79 1603 EXAMINER HORLICK, KENNETH R ART UNIT PAPER NUMBER 1637 MAILDATE DELIVERY MODE 06/28/2016 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 PATENT TRIAL AND APPEAL BOARD Ex parte ELAZAR RABBANI, JANNIS G. STA VRIANOPOULOS, JAMES J. DONEGAN, WAYNE PATTON, and JUAN CARCAM0 1 Appeal 2014-001837 Application 12/004,842 Technology Center 1600 Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, 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 chimeric nucleic acid and a process for isolating one or more species of, or detecting the presence or quantity of, a nucleic acid of interest. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 According to Appellants, the real party in interest is Enzo Biochem, Inc. (Br. 2.) Appeal2014-001837 Application 12/004,842 STATEMENT OF THE CASE Background "This invention provides a composition which comprises a nucleic acid portion that provides specific hybridization to a nucleic acid analyte of interest and a nonnucleic acid portion that comprises at least one member of an affinity binding pair that allows capture of the composition to a solid matrix." (Spec. 14, 11. 2-5.) Claims on Appeal Claims 15-20, 23-28, 31-37, 40-48, and 51-54 are on appeal. (Claims Appendix, Br. 20-27.) Independent claim 15 is illustrative and reads as follows: 15. A chimeric nucleic acid comprising at least two portions, a first portion comprising a nucleic acid complementary to a nucleic acid sequence of interest, and a second portion comprising one member of a peptide affinity group, wherein said member is attached to one or more nucleotides of said nucleic acid in said first portion. (Id. at 20.) Examiner's Rejections 1. Claims 15-19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Hanna2 and Schneider. 3 (Final Act. 2.)4 Appellants argue claims 15- 19 as a group, and we therefore limit our discussion to claim 15. 2. Claims 20, 23-28, 31-37, and 40-47 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Hanna, Schneider, and Cocuzza. 5 (Id. at 4.) 2 Hanna, US 2005/0064414 Al, published Mar. 24, 2005 ("Hanna"). 3 Schneider et al., US 6,982,146 Bl, issued Jan. 3, 2006 ("Schneider"). 4 Office Action dated July 3, 2012. 5 Cocuzza, US 4,908,453, issued Mar. 13, 1990 ("Cocuzza"). 2 Appeal2014-001837 Application 12/004,842 Appellants argue claims 20, 23-28, 31-37, and 40-47 as a group, and we therefore limit our discussion to claim 20. 3. Claims 48 and 51-54 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Hanna, Schneider, Cocuzza, and Houghton. 6 (Id. at 5.) Appellants argue claims 48 and 51-54 as a group, and we therefore limit our discussion to claim 48. 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. Hanna teaches a chimeric nucleic acid comprising a nucleic acid and a polyhistidine affinity tag. (Hanna, i-fi-156, 125, 164--165, and Figs. 8, 20.) FF 2. Hanna teaches that target DNA or RNA can be attached to a "solid support, for example, to which an oligonucleotide that contains a second target-specific sequence, which is termed a 'capture sequence,' has been attached via any number of immobilization tags." (Hanna i-fi-172, 264.) FF 3. Hanna teaches the use of an immobilized capture probe to hybridize with a target pathogen polynucleotide to detect pathogens, and diagnostic assays. (Hanna i-fi-1267, 274.) FF 4. The Examiner finds that Schneider discloses that "the use of peptide affinity groups including S-peptide and GST7 was conventional in the art at the time of the invention." (Final Act. 3, citing Schneider col. 18, 1. 9-col. 19, 1. 32.) 6 Houghton et al., US 5,863,719, issued Jan. 26, 1999 ("Houghton"). 7 GST stands for glutathione-5-transferase. (Schneider col. 18, 1. 16.) 3 Appeal2014-001837 Application 12/004,842 FF 5. The Examiner finds that Cocuzza discloses "an oligonucleotide with affinity binding pair member biotin attached to the 5 '-phosphate through a linker arm." (Id. at 4, citing Cocuzza col. 13, 11. 15-21.) FF 6. Houghton teaches "hybridization assays which utilize both capture and label probes." (Houghton col. 21, 11. 43--44.) ISSUE Whether a preponderance of evidence of record supports the Examiner's conclusion of obviousness under 35 U.S.C. § 103(a). DISCUSSION Principles of Law "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'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417. Analysis Rejection No. I-Claim 15 The Examiner concluded that it would have been prima facie obvious to make the claimed chimeric nucleic acid by substituting a peptide affinity group, such as S-peptide or GST, for the polyhistidine affinity tag in the oligonucleotide capture probe of Hanna. (Final Act. 3.) Furthermore, the Examiner found that one of ordinary skill in the art would have been motivated to do so because Schneider discloses that, "besides polyhistidine which binds to metal, various peptide affinity group members like S-peptide and GST were conventionally used in the art in an analogous manner." (Id.) 4 Appeal2014-001837 Application 12/004,842 We note that, like the polyhistidine tag of Hanna (FF 2), Schneider discloses that its affinity tags are useful for allowing attachment of a target molecule to a substrate (see FF 4), as the Examiner contends. Accordingly, 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, 550 U.S. at 398. Moreover, the Examiner has established a prima facie case of obviousness and Appellants have not overcome that prima facie case. Appellants argue that the histidine tag taught by Hanna "will randomly bind to a site on a support that incorporates a metal" whereas the present invention uses chimeric nucleotides "that include one member of a peptide affinity group ... where the peptide does not comprise only one type of amino acid and does not bind indiscriminately to its binding partners." (Br. 15.) Appellants argue further that Schneider "discloses the use of protein affinity tags for purification of recombinant proteins" but "does not teach or suggest using a peptide affinity group attached to a nucleotide to immobilize, isolate, identify and/or quantify nucleic acids." (Id. at 16.) Finally, Appellants argue that "the skilled artisan would not consider the addition of a peptide or protein affinity tag to a protein ... to be analogous to addition of a peptide or protein to a polynucleotide." (Id.) We are not persuaded. We note at the outset that the test for obviousness is what the combined teachings of Hanna and Schneider would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases). Moreover, one cannot establish nonobviousness by attacking references individually where the Examiner bases the rejection on a combination of references. Id. at 426. 5 Appeal2014-001837 Application 12/004,842 The combination of references, as applied by the Examiner, involves the substitution of a known peptide affinity group member for the polyhistidine affinity tag of Hanna, yielding a predictable result--attachment of a target molecule to a substrate. See KSR, 550 U.S. at 416-17. Moreover, while Appellants argue that "polynucleotides are chemically different from proteins and methods of preparing a fusion protein are more straightforward than chemical methods of producing chimeric nucleic acid molecules" (Br. 16), Appellants have not provided a persuasive reason why a skilled artisan would not be able to make the substitution at issue here. The rejection of claim 15 is affirmed. Rejection No. 2-Claim 20 The Examiner concluded that the method of claim 20 would have been prima facie obvious to one of ordinary skill in the art, based on the combined teachings of Hanna, Schneider, and Cocuzza. (Final Act. 4--5.) Appellants rely on the same arguments as set forth above in connection with claim 15, and further state that "Cocuzza does not disclose compositions comprising chimeric oligonucleotides comprising a first member of a peptide affinity group, or their use in isolating, detecting, or quantifying nucleic acids of interest by binding to a matrix comprising a second member of the peptide affinity group." (Br. 18.) Accordingly, because we are not persuaded, for the reasons set forth above, that the Examiner failed to make out a prima facie case of obviousness as to claim 15, and because Appellants present no additional substantive arguments with respect to the rejection of claim 20, we affirm that rejection as well. See Hyattv. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008). 6 Appeal2014-001837 Application 12/004,842 Rejection No. 3-Claim 48 The Examiner concluded that the method of claim 48 would have been prima facie obvious to one of ordinary skill in the art, based on the combined teachings of Hanna, Schneider, Cocuzza, and Houghton. (Final Act. 5---6.) Appellants rely on the same arguments as set forth above in connection with claims 15 and 20, and further state that "Houghton does not disclose compositions comprising a chimeric oligonucleotide comprising a first member of a peptide affinity group or their use in isolating, detecting, or quantifying nucleic acids of interest by binding to a matrix comprising a second member of the peptide affinity group." (Br. 19.) Accordingly, for the reasons set forth above, and because Appellants present no additional arguments with respect to the rejection of claim 48, we affirm that rejection as well. See Hyatt, 551 F .3d at 1314. Conclusion of Law A preponderance of evidence of record supports the Examiner's conclusion that claim 15 is obvious under 35 U.S.C. § 103(a). Claims 16-19 were not argued separately and fall with claim 15. A preponderance of evidence of record supports the Examiner's conclusion that claim 20 is obvious under 35 U.S.C. § 103(a). Claims 23- 28, 31-37, and 40-47 were not argued separately and fall with claim 20. A preponderance of evidence of record supports the Examiner's conclusion that claim 48 is obvious under 35 U.S.C. § 103(a). Claims 51-54 were not argued separately and fall with claim 48. SUMMARY We affirm the rejections of all claims on appeal. 7 Appeal2014-001837 Application 12/004,842 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