Appeal No. 2003-1469 Page 8
Application No. 08/479,886
specification states that substitutions in site 1 should be with amino acids that are
closely related to the naturally occurring amino acid. See id.
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 this may entail a greater
number of possible substitutions compared to site 1, it evidences a
correspondingly higher degree of predictability in achieving 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 level of 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
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