Appeal No. 2003-1469 Page 5
Application No. 08/479,886
Discussion
Claim 57, the broadest claim on appeal, is directed to a nucleic acid
encoding a variant of the class of proteins that includes growth hormone,
prolactin, etc. The variant encoded by the claimed nucleic acid has at least two
mutations compared to the wild-type protein: one in a portion of the protein
corresponding to receptor-interacting “site 2” and one in a portion of the protein
corresponding to receptor-interacting “site 1”.
The examiner acknowledged that the claims were enabled for nucleic
acids “encoding those exemplified human growth hormone (hGH) variants in
which specified amino acids are replaced by alanine or by other exemplified
amino acids (such as D26E or Q29S)” but rejected the claims on the basis that
practicing their full scope (specifically “nucleic acids encoding 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 nucleic acids encoding 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).”
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