In re Wallach, 03-1327.

Citation378 F.3d 1330
Decision Date11 August 2004
Docket NumberNo. 03-1327.,03-1327.
PartiesIn re David WALLACH, Hartmut Engelmann, Dan Aderka, Daniela Novick and Menachem Rubinstein.
CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit

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 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 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, according to Appellants, the specification establishes that the present inventors were in fact in possession of the entire claimed genus of DNA sequences at the time the application was filed.

Appellants also argue that this case is distinguishable from past written description cases such as Amgen v. Chugai and Fiers, because Appellants have provided an actual amino acid sequence that is encoded by the claimed DNA, not simply the name of the protein and a statement that the DNA can be obtained by reverse transcription. Appellants contend that this case is also distinguishable from Lilly because the inventors here are not attempting to claim DNA molecules encoding a plurality of unknown proteins from various species having no common features, but only those encoding the single protein sequence that is actually set forth in the specification. Finally, Appellants argue that, because there is a known correlation between the function (i.e., encoding a specified amino acid sequence) and structure, this is the quintessential example of the sort of functional description permitted by § 112 in view of our decision in Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed.Cir.2002). Appellants argue that our recent decision in Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed.Cir.2003), which issued after the Board's opinion in the present case, reaffirmed that § 112 only requires a court to determine whether a specification conveys to one of ordinary skill in the art as of the filing date that the inventors invented the claimed subject matter.

The PTO responds by arguing that Appellants' specification includes neither any actual DNA sequence within the scope of the claims nor the complete amino acid sequence of the TBP-II protein, but only the sequence of ten out of the 185-192 amino acids that make up the protein. Furthermore, the PTO argues, the only disclosed function of the claimed DNA molecules is to encode the TBP-II protein, and no information is provided from which the claimed DNA molecules can be distinguished from other DNA molecules. According to the PTO, the identity of the nucleic acid encoding a protein is not an inherent property of the protein. If Appellants' reasoning were accepted, the PTO asserts, the result would be that the disclosure of an isolated protein would be prior art under § 102 with respect to claims directed to any nucleic acid encoding the protein. Finally, the PTO contends, substantial evidence supports the Board's factual finding that Appella...

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