Appeal 2007-1633
Application 09/480,236
Therefore, the issue distills down to whether one skilled in the art
would be able to determine which CD3-binding domains having 90%
identity to the variable region of UCHT-1 using the Bestfit program and at
least one sequence segment of at least five amino acids of human origin, are
also at least about 90% as effective on a molar basis in competing with
UCHT-1 for binding to human CD3 antigen. In this regard, Appellants
direct attention to Hexham2 to support the assertion that “determining the
binding affinity of a given antibody for CD3 relative to UCHT-1 is well
within the skill in the art . . .” (Br. 6). The problem with this argument,
however, is that Hexham is a post-filing date reference. As set forth in In re
Glass, 492 F.2d 1228, 1232, n. 6, 181 USPQ 31, 34-35, n. 6 (Fed. Cir.
1974), “later issuing patents or publications may not be relied upon to
establish that the Specification is enabling under . . .” 35 U.S.C. § 112, first
paragraph. Accordingly, we look to Appellants’ Specification for an
enabling description of determining whether a CD3-binding domain is at
least about 90% as effective on a molar basis in competing with UCHT-1 for
binding to human CD3. However, we do not find, and Appellants do not
identify, any disclosure in the Specification that teaches a person of skill in
the art how to determine whether a CD3-binding domain is at least about
90% as effective on a molar basis in competing with UCHT-1 for binding to
human CD3. At best, we find that Appellants’ Specification discloses that
such CD3-binding domains are considered to be within the scope of their
claimed invention (Specification 21).
2 Hexham et al., Influence of relative binding affinity on efficacy in a panel
of anti-CD3 scFv immunotoxins, 38 Mol. Immunol. 397-408 (2001).
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