Acknowledging that a structure-function relationship can provide adequate written description for claims to genetic material, the U.S. Court of Appeals for the Federal Circuit nevertheless held that a partial amino acid sequence failed to provide the requisite correlation for describing a claimed nucleotide sequence. In re Wallach, Case No. 03-1327 (Fed. Cir. Aug. 11, 2004) (Lourie, J).
Wallach discovered tumor necrosis factor (TNF) binding proteins I and II (TBP-I and II), which selectively inhibit cytotoxic effects of tumor necrosis factor, based on a partial amino acid sequence, molecular weight and functional characteristics of TBP-II. The U.S. patent application 08/485,129 (the `129 application) is directed to an isolated DNA molecule encoding TBP-II characterized by partial amino acid sequence, molecular weight and TNF inhibitory effect. Affirming the U.S. Patent and Trademark Office’s rejection, the Board of Patent Appeals and Interferences (Board) concluded that the `129 application fails to describe the claimed genetic material with sufficient specificity to satisfy the written description requirement of §112, first paragraph.
On appeal Wallach argued that the DNA claims are sufficiently described because they do not differ in substance from previously allowed claims directed to TBP-II protein in view of the "unequivocal correspondence" between amino acids and the encoding genetic material. Wallach additionally asserted that the complete amino acid sequence of a protein is an inherent property of an isolated protein and distinguished the precedential Lilly decision, which rejected the description based on functional characteristics, because an actual partial amino acid sequence had not been provided. Wallach contended that a partial amino acid sequence of an isolated protein confers possession of the entire encoding DNA sequence given the known correlation between encoding function and protein structure.
Recognizing that the state of the art has sufficiently developed to where an amino acid sequence might confer possession of the genus of encoding DNA sequences, the Federal Circuit indicated that DNA molecules defined only in terms of the protein sequence, although containing a large number of species, are sufficiently definite to be deemed adequately described. However, rather than claiming a nucleic acid encoding the protein segment represented by the partial protein sequence, the `129 application instead encompasses the entire TBP-II protein. Absent the remaining 95 percent of the TBP-II amino acid sequence, the Court held that the `129 application failed to adequately describe the claimed DNA molecules. The Court further concluded that the additional functional characterizations were similarly insufficient to describe the full DNA sequence, reasoning that physical possession of the protein failed to confer knowledge of the protein’s sequence or other descriptive properties sufficient to deduce the encoding DNA sequence. The Court also rejected applicability of a structure-function relationship because without a complete amino acid sequence the well known relationship between a nucleic acid’s structure and its amino acid encoding function could not be exploited.
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