Appeal No. 1996-2539
Application 08/150,776
permitted amino acid substitutions are those that result in a variant having “less than 10%
crossreactivity with the parent peptide at either the B cell or T cell level” (page 14).
Written Description
As set forth in Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111,
1117 (Fed. Cir. 1991), “the original disclosure of the application need only convey the
concept now claimed in order for the written description requirement of 35 U.S.C. § 112,
first paragraph, to be satisfied.” The issue raised by the examiner is whether the original
disclosure describes a vaccine “essentially free of permitted variants of hepatitis B virus
surface antigen having the sequence (CTKPSDGNC) within residues S(139-147).”
The examiner notes that “the specification fails to explicitly teach the omission of
permitted variants from the vaccines of the invention” and concludes that “[t]his silence
cannot be construed as supporting a positive recitation of exclusion of permitted variants.”
Examiners Answer, Section (11). We disagree with the examiner’s conclusion.
The specification discloses both permitted and non-permitted variants of HBsAg,
and vaccine compositions comprising HBsAg and the non-permitted variants are
expressly described. There is no mention of including permitted variants in the vaccines.
On balance, we believe this speaks more towards not including permitted variants in the
compositions, but it is true that the specification does not expressly exclude them. Thus,
the specification conceivably conveys two concepts: (1) a vaccine composition including
HBsAg, non-permitted variants and permitted variants, and (2) an otherwise identical
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