Appeal No. 2004-2314 Page 6
Application No. 09/971,101
In this case, the complete structure of SEQ ID NO:2 and SEQ ID NO:4
has been described, and the polypeptides of the claimed genus share at least 10
contiguous amino acids of the structure of SEQ ID NO:2 or SEQ ID NO:4.4 Thus,
the structural features that are common to the genus make up at least 10
contiguous amino acids of the structure set forth in SEQ ID NO: 2 or SEQ ID
NO:4. The examiner has not adequately explained why this degree of structural
similarity is inadequate to “constitute a substantial portion of the genus,” as
required by Lilly. Accordingly, we reverse the rejection of claims 26-31 under 35
U.S.C. § 112, first paragraph, as the specification that fails to adequately
describe the claimed invention.
Enablement:
The examiner concedes (Answer, page 16), “the specification teaches
how to make the genus of polypeptides comprising an ‘isolated and purified
polypeptide fragment of SEQ ID NO: 2 or 4’ that has ‘at least’ 10, 20, 30, 40, 75,
or 100 ‘contiguous amino acids of SEQ ID NO:2 or SEQ ID NO:4’.” The
examiner also concedes (Answer, bridging sentence, pages 12-13), “a small
population, of the polypeptides encompassed by the claimed genus would be
useful in preparing … antibodies.”5 Nevertheless, the examiner finds (Answer,
page 17), “[a]ppellants[’] specification has failed to enable the claimed genus of
4 In this regard, we note that the examiner concedes (Answer, page 10), “that a polypeptide
which consists of contiguous amino acids from SEQ ID NO:2 or SEQ ID NO: 4 is fully described
by the specification….”
5 We note, however, that the examiner fails to identify which “population” would be useful in
preparing antibodies, or why only a “small population would have this utility.
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