Appeal No. 2003-1668 Page 8
Application No. 08/479,883
With site 2 mutations, again, the examiner’s position ignores the
specification’s guidance. The specification states that site 2 should be mutated
in such a way as to disrupt receptor binding; thus, site 2 mutations should be
selected so as to change the characteristics of the naturally occurring amino acid
as much as possible. See Table 1a, page 11. While the number of possible
substitutions is therefore larger than at site 1, each substitution is more likely to
achieve the desired result. That is, it is much easier to make an amino acid
substitution that destroys a given function than it is to make a substitution that
preserves or enhances it.
Thus, while the scope of the claims as written may encompass variants
that have any of 19 possible substitutions at any of a variety of positions, the
specification guides those of skill in the art toward subsets of potential mutations
that are more likely than others to have the desired biological activity. This
guidance considerably reduces the amount of experimentation that would be
expected to be necessary to practice the claimed invention.
In addition, the examiner has conceded that “the skill in the art is known to
be high,” Examiner’s Answer, page 8, and does not dispute that the specification
provides the methods and assays needed to practice the invention. See id.,
page 11:
Appellant [sic] asserts that “the specification also provides
considerable direction and guidance on how to practice the claimed
invention” in that tools for practicing the invention and assays are
provided for assessing affinity. It is not disputed that the instant
specification provides these elements, however, this is not the type
of guidance that is lacking and which is necessary for practicing the
invention as claimed.
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