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

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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.

BACKGROUND

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).

DISCUSSION

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: Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr in the portion of the protein sequenced by N-terminal sequence analysis, said protein having the ability to inhibit the cytotoxic effect of TNF, wherein said naturally occurring TBP-II protein is the same as that protein having the ability to inhibit the cytotoxic effect of TNF which, after being purified by subjecting a crude protein recovered from a dialyzed concentrate of human urine to affinity chromatography on a column of immobilized TNF, elutes from a reversed-phase high pressure liquid chromatography column as a single peak in a fraction corresponding to about 31% acetonitrile and shows a molecular weight of about 30 kDa when measured by SDS-PAGE under reducing conditions.

On appeal, Appellants argue that the PTO has effectively conceded that the TBP-II protein, which the claimed isolated DNA encodes, is sufficiently described in the specification to comply with § 112, because the claims of United States patent application 07/930,443, of which the '129 application is a division (which, by definition, has the same specification), have been allowed but for their involvement in an interference proceeding. According to Appellants, those claims do not differ in substance from the present claims except insofar as they are directed to a partial protein sequence, rather than to the DNA sequences encoding the protein. Appellants contend that that is not a meaningful distinction, because the genetic code is based on an unequivocal correspondence between amino acids and encoding DNA codons, and determination of the amino

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acid sequence of a protein automatically puts one in possession of all DNA sequences encoding that protein. Appellants also argue that the complete amino acid sequence of a protein is an inherent property of an isolated protein that has been fully characterized by partial amino acid sequence and other characteristics, and that the complete amino acid sequence of a protein therefore puts one in possession of all DNA sequences encoding it. Therefore,...

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