Appeal No. 2001-2308
Application 07/704,578
that the reference products are identical, or substantially identical, to the product as
claimed.
Hirano describes a purified product designated “BCDF” containing two bands of
protein, and speculates that the difference in molecular weights “is the result of post-
translational modification or the formation of breakdown products.” Appellants argue that
without a comparison of the amino acid sequences of these protein species it is
impossible to assume that a single protein is present. The examiner argues that the
specific activity is an indication of a substantially pure protein and is sufficient to identify
the protein. The examiner also argues that the amino acid sequence is inherent to the
protein. However, we note that the reference relied upon by the examiner identified as JP
61-115025 discusses “BCDF” and lists Hirano as an inventor. In the Japanese patent,
“BCDF” was made from a similar cell line and purified by the same procedure as reported
in Hirano. The N-terminal sequence of “BCDF” is reported as
Pro Val Pro Pro Gly Glu Asp Ser Lys Asp Val Ala Ala which lacks the N-terminal Ala
residue recited in the claimed protein. Viewing these references together, we find that the
Japanese patent provides evidence that the protein(s) of Hirano do not necessarily meet
the particular limitations of claim 29. In our view, these circumstances are such that the
examiner needed to explain the discrepancy between the respective amino acid
sequences and explain how Hirano suggests the particular claimed product. The examiner
did not do so.
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