Ex Parte Cicciarelli et alDownload PDFPatent Trial and Appeal BoardJan 12, 201814134342 (P.T.A.B. Jan. 12, 2018) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/134,342 12/19/2013 James Cicciarelli NITF-006-US 1063 89633 7590 Brian Pangrle Pangrle Patent, Brand & Design Law, P.C. 3500 W Olive Ave 3rd Floor Burbank, CA 91505 EXAMINER SCHWADRON, RONALD B ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 01/17/2018 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): brian@ppbdlaw.com docket @ ppbdlaw .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES CICCIARELLI, NORI KASAHARA, and NATHAN LEMP1 (Applicant: NATIONAL INSTITUTE OF TRANSPLANTATION FOUNDATION) Appeal 2016-008686 Application 14/134,342 Technology Center 1600 Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and DAVID COTTA, 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 comprising administering a donor-specific IgG4 antibody to a tissue transplant recipient. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellants, the real party in interest is The National Institute of Transplantation Foundation. (Appeal Br. 2.) Appeal 2016-008686 Application 14/134,342 STATEMENT OF THE CASE Background “For transplant recipients, various donor-specific human leukocyte antigen (HLA) antibodies have been associated with rejection.” (Spec. 116.) “[D]ata indicate that level of IgG subclass G4 plays a role [in transplant recipients], for example, where a higher level of G4 is beneficial to transplant recipients.” {Id. 117.) Claims on Appeal Claims 1—6 are on appeal. (Appeal Br. 15 (APPENDIX A—Appealed Claims).) Claim 1 is illustrative and reads as follows: 1. A method comprising: administering a donor-specific human leukocyte antigen antibody to a tissue transplant recipient wherein the antibody comprises an immunoglobulin G subclass 4 antibody (G4). Examiner’s Rejections 1. Claims 2—6 stand rejected under 35 U.S.C. § 112(b) or 35 U.S.C. §112 (pre-AIA), second paragraph, as being incomplete for omitting essential steps. (Ans. 2.) 2. Claims 1—6 stand rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Cicciarelli2 and Zand.3 (Id. at 2 4.) 3. Claims 2—6 stand rejected under 35 U.S.C. § 101 as directed to non- 2 Cicciarelli et al., US 2010/0261203 Al, pub. Oct. 14, 2010 (“Cicciarelli”). 3 M. Zand, HLA-ABC blocking antibodies, Internet entry (dated 2002) at https://lists.purdue.edu/pipermail/cytometry/2002-November/023367.html (“Zand”). 2 Appeal 2016-008686 Application 14/134,342 statutory subject matter. (Id. at 4—6.) DISCUSSION Rejection No. 1 Issue Whether a preponderance of evidence of record supports the Examiner’s rejection under Section 112. Analysis Dependent claim 2 recites “[t]he method of claim 1 comprising monitoring level of G4 in the recipient.” (Appeal Br. 15.) Claims 3—6 depend, directly or indirectly, on claim 2. (Id.) The Examiner rejects claim 2—6 “as being incomplete for omitting essential steps, such omission amounting to a gap between the steps.” (Ans. 2, citing MPEP § 2172.01.) According to the Examiner, “[t]he omitted steps are steps related to how the level of G4 is actually monitored.” (Id.) Appellants argue that “[t]he Examiner does not demonstrate that dependent claim 2 ‘fails to interrelate essential elements of the invention as defined by applicant(s) in the specification’ nor that dependent claim 2 fails ‘to point out and distinctly claim the invention’.” (Appeal Br. 5.) Appellants also refer to page 12 of the Specification as describing how the presence and specificity of antibodies was determined. (Id. at 5—6.) We find that Appellants have the better position. MPEP § 2172.01 reads in pertinent part: “a claim which fails to interrelate essential elements of the invention as defined by applicant(s) in the specification may be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, for failure to point out and distinctly claim the invention.” (Id.) Nowhere does the Examiner explain why a particular method of monitoring 3 Appeal 2016-008686 Application 14/134,342 the level of G4 is an essential element of the claimed invention, or why the “how” of monitoring G4 level would not be clear to a person of ordinary skill in the art. See In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014). See also Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (“[A] patent need not teach, and preferably omits, what is well known in the art.”). Accordingly, we reverse the Examiner’s rejection under Section 112. Rejection No. 2 Issue Whether a preponderance of evidence of record supports the Examiner’s rejection under pre-AIA 35 U.S.C. § 103(a). Analysis The Examiner finds that Cicciarelli teaches that transplant patients are monitored for the presence of donor specific human HLA antibodies, that measurements can be used to determine the amount of IgG4, and that increased levels of IgG4 antibodies correlate with a favorable clinical outcome. (Ans. 2, citing Cicciarelli claims 1, 9 and Tflf 95, 169.) However, the Examiner acknowledges that Cicciarelli “[does] not teach the method of claim 1.” {Id. at 3.) The Examiner cites to Zand to show “[t]he use of blocking antibodies to block binding of alio antibodies to a target cell was known in the art.” {Id.) Zand is an Internet entry from a Dr. Martin S. Zand that reads (in its entirety) as follows: Fellow Flow'ers We are interested in blocking the binding of allo-antibodies directed against HLA-ABC on human CD4+ cells. Does 4 Appeal 2016-008686 Application 14/134,342 anybody know of a good mono or polyclonal reagent that will do this? Thanks. Martin (Zand. 1) Appellants contest the obviousness rejection. (Appeal Br. 10-13.) The Examiner bears the initial burden of establishing a prima facie case of obviousness and has not done so. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We agree with the Examiner that Cicciarelli does not teach the method of claim 1, but we do not agree that the Zand remedies the deficiency of Cicciarelli. Zand does not mention IgG4 and appears to be an inquiry about an experimental “reagent.” Moreover, the Examiner has not established that Cicciarelli and Zand teach or suggest “administering ... to a tissue transplant recipient... an immunoglobulin G subclass 4 antibody (G4)” as recited in claim 1. CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) (a prima facie case for obviousness requires a suggestion of all limitations in a claim). Accordingly, we reverse the rejection of claims 1—6 for obviousness. Rejection No. 3 Issue Whether a preponderance of evidence of record supports the Examiner’s rejection under 35 U.S.C. § 101. Analysis The Examiner rejects dependent claims 2—6 (but not independent claim 1) as directed to non-statutory subject matter, i.e. claiming a law of nature. (Ans. 4—6.) Appellants contest the rejection, arguing (in part) that 5 Appeal 2016-008686 Application 14/134,342 “[t]he law as to analysis under 35 U.S.C. 101 is settled in that a claim must be considered in its entirety.” (Reply Br. 9—10.) In analyzing patent eligibility questions under 35 U.S.C. § 101, the Supreme Court instructs us to “first determine whether the claims at issue are directed to a patent-ineligible concept.” Alice Corp. Pty Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014). If this threshold is met, we move to a second step of the inquiry and “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id. (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1297 (2012)). As to this second step of the analysis, our reviewing court has recently held that in examining claims under step two, we must view them as a whole, considering their elements “both individually and ‘as an ordered combination.’” Alice, 134 S.Ct. at 2355 (quoting Mayo, 132 S.Ct. at 1298). RapidLitig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1051 (Fed. Cir. 2016). We find that Appellants have the better position. Dependent claims 2—6 include the limitations of claim 1, which the Examiner finds is directed to statutory subject matter. Thus, regardless of the conclusion as to step one of the Alice inquiry, when dependent claims 2—6 are properly viewed in their entirety, they are (like claim 1) directed to statutory subject matter. See id. Accordingly, we reverse the rejection of claims 2—6 under Section 101. 6 Appeal 2016-008686 Application 14/134,342 Conclusions A preponderance of evidence of record fails to support the Examiner’s rejections of (1) claims 2-6 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre- AIA), second paragraph; (2) claims 1—6 under pre-AIA 35 U.S.C. § 103(a); and (3) claims 2—6 under 35 U.S.C. § 101. SUMMARY We reverse the rejections of all claims on appeal. REVERSED 7 Copy with citationCopy as parenthetical citation