Appeal No. 2003-1668 Page 5
Application No. 08/479,883
hormone variant having at least two mutations: one each in the receptor-
interacting “site 1” and “site 2” regions.
The examiner acknowledged that the claims were enabled for “those
exemplified human growth hormone (hGH) variants in which specified amino
acids are replaced by alanine or by other exemplified amino acids” but rejected
the claims on the basis that practicing their full scope (specifically “hGH variants
in which any amino acid in a particular domain is replaced by any other amino
acid”) would have required undue experimentation. See the Examiner’s Answer,
page 3.
The examiner’s main concern seemed to be with the experimentation
required to use the claimed products rather than that required to make them.
See the Examiner’s Answer, page 7: “It can be said that the skilled artisan could
make molecules which meet the structural limitations of the claims but the
molecules could not be used without a knowledge of whether the molecules have
an increased or decreased affinity for the receptor (i.e. antagonistic or agonistic
properties).”
The examiner considered the factors set out in In re Wands, 858 F.2d 731,
737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), and concluded that “the breadth of
the instant claims is not commensurate in scope with the specification.”
Examiner’s Answer, pages 8-9. The examiner summed up her position as
follows: “Unless one has a reasonable expectation that any one material
embodiment of the claimed invention would be more likely than not to function in
the manner disclosed or the instant specification provides sufficient guidance to
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