378 F.3d 1330 (Fed. Cir. 2004), 03-1327, In re Wallach

Docket Nº:03-1327.
Citation:378 F.3d 1330
Party Name:In re David WALLACH, Hartmut Engelmann, Dan Aderka, Daniela Novick and Menachem Rubinstein.
Case Date:August 11, 2004
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit

Page 1330

378 F.3d 1330 (Fed. Cir. 2004)

In re David WALLACH, Hartmut Engelmann, Dan Aderka, Daniela Novick and Menachem Rubinstein.

No. 03-1327.

United States Court of Appeals, Federal Circuit

August 11, 2004

Page 1331

Roger L. Browdy, Browdy and Neimark, P.L.L.C., of Washington, DC, argued for appellants.

Mary L. Kelly, Associate Solicitor, Office of the Solicitor, United States Patent and Trademark Office, of Arlington, VA, argued for the Director of the U.S. Patent and Trademark Office. With her on the brief were John M. Whealan, Solicitor; and Raymond T. Chen, Associate Solicitor. Of counsel were Stephen Walsh and William LaMarca, Associate Solicitors.

Before MAYER, Chief Judge, LOURIE and GAJARSA, Circuit Judges.

LOURIE, Circuit Judge.

David Wallach, Hartmut Engelmann, Dan Aderka, Daniela Novick, and Menachem Rubinstein (collectively, "Appellants") appeal from the decision of the United States Patent and Trademark Office ("PTO") Board of Patent Appeals and Interferences affirming the rejection of claims 11-13, 35-38, 43, 44, 46-49, 51-54, 56-61, 63, and 64 of United States patent application 08/485,129 under the written description requirement of 35 U.S.C. § 112. In re Wallach, Appeal No. 2002-1363 (Bd. Pat. Apps. & Interfs. Dec. 26, 2002). We affirm.


In the 1980s, Appellants apparently discovered two specific proteins isolated from human urine that, among other things, selectively inhibit the cytotoxic effect of tumor necrosis factor ("TNF"). They named the compounds TNF binding proteins I & II ("TBP-I" and "TBP-II"). After obtaining a partial amino acid sequence of the N-terminal portion of TBP-II and determining that the complete protein has a molecular weight of about 30 kilodaltons ("kDa") when measured by sodium dodecyl sulfate polyacrylamide gel electrophoresis ("SDS-PAGE") under reducing conditions, Appellants filed a patent application including, inter alia, claims directed to proteins having that molecular weight and partial sequence (i.e., threonin e-proline-tyrosine-alanine-proline-glutamic acid-proline-glycine-serine-threonine, or "Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr") and having the ability to inhibit the cytotoxic effect of TNF. Appellants' application also included

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claims to isolated DNA molecules that encode the claimed proteins. The PTO issued a restriction requirement and Appellants filed divisional applications. The claims directed to the proteins having the stated partial sequence are currently involved in an interference proceeding and are not at issue here. The claims at issue, those directed to the DNA, were rejected under § 112 "as based on a specification which does not provide an adequate written description of the claimed invention." Wallach, slip op. at 2. After several unsuccessful attempts to traverse that rejection, Appellants appealed to the Board.

Citing this court's decisions in Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed.Cir. 1991), Fiers v. Revel, 984 F.2d 1164 (Fed.Cir. 1993), and Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir. 1997), the Board affirmed the examiner's rejection. In particular, the Board held that "(1) applicants do not describe the genetic material sought to be patented in claim 11 with sufficient specificity in their specification; and (2) the examiner did not err in finding that claim 11 is based on a specification which does not provide adequate, written descriptive support for the claimed subject matter." Wallach, slip op. at 8-9.1

Appellants now appeal. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).


Claim 11 of the '129 application reads as follows:

11. An isolated DNA molecule comprising a contiguous nucleotide sequence coding for a protein consisting of naturally occurring human Tumor Necrosis Factor (TNF) Binding Protein II, herein designated TBP-II, said TBP-II including the amino acid sequence...

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