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Partial Protein Sequence Does Not Provide Sufficient Written Description

03-1327
August 11, 2004

Decision icon Decision

Last Month at the Federal Circuit - September 2004

Judges: Lourie (author), Mayer, and Gajarsa

In In re Wallach, No. 03-1327 (Fed. Cir. Aug. 11, 2004), the Federal Circuit affirmed a decision of the Board that upheld a rejection of several claims of U.S. Patent Application No. 08/485,129 (“the ‘129 application”) by David Wallach et al. (collectively “Wallach”) for failure to provide an adequate written description.

The ‘129 application is directed to two specific tumor necrosis binding proteins (“TBP-I” and “TBP-II”) that inhibit the cyto toxic effect of tumor necrosis factor (“TNF”). Among other aspects of the invention, Wallach claimed proteins having a partial sequence, a particular molecular weight, and the ability to inhibit the cytotoxic effect of TNF. The disclosed sequence included only the partial amino acid sequence for the N-terminal portion of TBP-II. The complete DNA sequence encoding the proteins was claimed in divisional application 07/930,443 (“the ‘443 application”), which had been allowed subject to an interference proceeding.

The patent Examiner rejected the claims of the ‘129 application under 35 U.S.C. § 112 because the specification did not provide an adequate written description of the claimed invention. The Board affirmed the rejections because Wallach did not describe the invention with sufficient specificity.

Wallach appealed, contending that because the ‘443 application had been allowed, the identical specification of the ‘129 application could not be viewed as inadequate. Wallach argued that the two applications differed substantively only because the ‘129 application claimed the partial protein sequence, whereas the ‘443 application claimed the DNA sequence encoding the protein. Citing the correspondence between the amino acid sequence and encoding DNA codons, Wallach argued that the distinction was not meaningful and, in fact, the amino acid sequence of a protein automatically puts one of ordinary skill in the art in possession of all DNA sequences encoding that protein. Moreover, Wallach argued that the complete amino acid sequence is an inherent property of an isolated protein that has been fully characterized by a partial amino acid sequence and other characteristics, such as molecular weight. Therefore, according to Wallach, the ‘129 application provided sufficient description for the entire claimed genus of DNA sequences. As a final point, Wallach also argued that the ‘129 application satisfied the written description requirement by providing a functional description of the identified protein, namely, the ability to selectively inhibit TNF.

The Federal Circuit recognized that a complete amino acid sequence of a protein may put one in possession of the genus DNA sequence that encodes it and, therefore, may satisfy the written-description requirement. Wallach, however, did not claim the nucleic acid sequence for the protein they disclosed. Rather, Wallach claimed only a partial sequence (approximately 5%) of the disclosed protein. The Court stated that mere possession of the protein does not amount to knowledge of that protein’s sequence absent any evidence that the sequence of the full protein can be deduced from a partial sequence.

Finally, the Court rejected Wallach’s functional-description argument. Acknowledging that the written-description requirement may be met by a functional description of the genetic material, the Court explained that there must be a relationship between the chemical structure and the biological function. Finding that no correlation existed between a protein’s partial structure, biological activity, and molecular weight on the one hand and the complete structure of the DNA encoding the protein on the other, the Federal Circuit affirmed the Board’s rejection of the claims.