Ex Parte GorlachDownload PDFPatent Trial and Appeal BoardSep 1, 201613253366 (P.T.A.B. Sep. 1, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/253,366 10/05/2011 Jorn Gorlach 26259 7590 09/06/2016 LICATA & TYRRELL P.C. 66 E. MAIN STREET MARLTON, NJ 08053 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. ALA0005US.Cl 9196 EXAMINER BRISTOL, LYNN ANNE ART UNIT PAPER NUMBER 1643 NOTIFICATION DATE DELIVERY MODE 09/06/2016 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): PTOactions@licataandtyrrell.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JORN GORLACH Appeal2015-000643 Application 13/253,3661 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving a claim directed to a method for producing a plurality of isolated antibodies for profiling antigen expression. Claim 5 is on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is Montecito Bio-Sciences, Ltd. App. Br. 1. Appeal2015-000643 Application 13/253,366 STATEMENT OF THE CASE The Specification states that the invention meets the "need in the art for a high-throughput approach [for] producing antibodies with a high affinity and [that] are antigen-specific" where the "antibodies [are] rapidly produced with minimal or no selection to eliminate the time-consuming processes of panning or screening." Spec. i-f 6. The Specification also states that a first exposure to an antigen results in production of IgM immunoglobulins and that "subsequent exposure provides a selection process among B-cells whereby a genetic rearrangement occurs within the antibody gene of the corresponding B-cell," which results in "a higher binding affinity antibody of a non-IgM class of immunoglobulin such as IgG, IgA, or IgE." Spec. i-f 4. Further, the Specification explains, "[t]his in vivo response is critical for obtaining high quality antibodies with a high binding affinity and has yet to be routinely replicated in vitro." Id. The Specification describes a method of making an array of antibodies. See, e.g., Spec. i-fi-1 7, 11, 16. The arrays are disclosed as suitable for, inter alia, profiling antigens derived from patient tissue samples. Spec. ,-r 53. The appealed claim can be found in the Claims Appendix of the Appeal Brief and reads as follows: 5. A method for producing a plurality of isolated antibodies for profiling antigen expression comprising (a) binding, in vitro, an isolated plurality of antibody-producing B-cells to an isolated plurality of cognate antigens from a mammal; (b) isolating each cognate antigen-bound antibody-producing B- cell; 2 Appeal2015-000643 Application 13/253,366 ( c) amplifying each nucleic acid sequence encoding each antibody, or fragment thereof, from each B-cell; ( d) introducing each amplified nucleic acid sequence encoding each antibody, or fragment thereof, into an expression system; ( e) expressing and purifying each antibody, or fragment thereof; and (f) preparing an array consisting of each purified antibody, or fragment thereof, from step ( e) on a substrate for profiling antigen expression. App. Br. 12 (Claims App'x). DISCUSSION The Examiner rejected claim 5 under 35 U.S.C. § 103(a) over Wagner.2 Final Action 4. The Examiner determined Wagner disclosed an array of protein-capture agents, arranged in a plurality of patches across a substrate, where the protein-capture agents can be a variety of antibodies (or fragments). Final Action 4--5. The Examiner determined that Wagner disclosed the antibodies can be expressed from recombinant DNA in vivo or in vitro. Final Action 5. The Examiner determined "Wagner teaches using a cell and its expression product and the cognate ligand in order to screen and select the partners in the pairing using an array format to screen the pairs." Final Action 6. Appellant contends the Examiner did not establish that Wagner taught or suggested all the limitations of claim 5. App. Br. 7. Specifically, Appellant argues the Examiner did not identify where or how Wagner 2 U.S. Patent No. US 6,365,418 Bl to Wagner et al. (issued Apr. 2. 2002) (hereinafter "Wagner"). 3 Appeal2015-000643 Application 13/253,366 disclosed "binding and isolating cognate antigen-bound antibody-producing B cells; [and] amplifying and expressing nucleic acids encoding each antibody or antibody fragment from the B-cells," as these steps are recited by claim 5. Id. Appellant's argument is persuasive. A proper § 103 analysis requires "a searching comparison of the claimed invention-including all its limitations-with the teachings of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). Here, the Examiner did not explain where the first 3 steps of claim 5 are disclosed in or suggested by Wagner. The Examiner's rejection focuses on the results of the claimed process, not the recited steps of the method claim, which are the limitations of the method-invention. The Examiner responds to Appellant's arguments by urging that steps "a" and "b" recited by claim 5 are to the product produced and are, thus, product-by-process limitations (Ans. 11 ), but this is not so---these limitations are composed as steps in a method. Wagner presents no discussion of combining B-cells with antigens, then isolating B-cells, and then amplifying the antibodies. Appellant argues (App. Br. 7-8) portions of Wagner directed to using lymphoid cells for expression and cloning to produce antibodies or fragments for an array (e.g., col. 25, 11. 42--45) do not teach or suggest binding B-cells with cognate antigens, isolating those bound pairs, and deriving nucleic acid sequences from the cells for amplification, per claim 5. Appellant's argument is persuasive and the Examiner has offered no persuasive evidence to the contrary. 4 Appeal2015-000643 Application 13/253,366 For the reasons presented above, we find the preponderance of the evidence of record does not support the Examiner's determination that the claim would have been obvious over Wagner. Therefore, we reverse. SUMMARY The rejection of claim 5 under 35 U.S.C. § 103(a) over Wagner is reversed. REVERSED 5 Copy with citationCopy as parenthetical citation