Appeal No. 2002-0091 Page 4
Application No. 08/479,884
one of the multiple-position variants fell into this category; the F191A variant (page
79) bound best, with a Kd(variant)/Kd(wt) value of 0.6.
Two of the exemplified variants within the scope of claim 88 had a
Kd(variant)/Kd(wt) value of 1, meaning that they bound the relevant target with the
same affinity as wild-type hGH. See page 54. Thus, among the exemplified
single- and multiple-position variants that are encompassed by claim 88, 43 out of
54 bound the target worse than wild-type hGH, while 9 out of 54 bound better and
2 out of 54 bound with the same affinity as wild-type hGH. In other words, 52 out
of 54 (about 96%) of the exemplified variants bound the target with an affinity
different from the affinity of wild-type hGH.
Discussion
Claim 88 is the broadest claim on appeal, and is directed to DNA encoding
an hGH variant having at least one amino acid substitution compared to the wild-
type protein; the substitution can be at any one of fifty-three specified sites in the
protein. The claim also requires that the variant encoded by the claimed DNA
must bind “to a target with an affinity different from the affinity of [wild-type] human
growth hormone.” Finally, the claim excludes DNA encoding naturally occurring
variants and a variant known as hGH-V.
The examiner acknowledged that the specification is “enabling for those
exemplified human growth hormone (hGH) variants in which specified amino acids
are replaced by alanine or by other amino acids.” Examiner’s Answer, page 3.
She concluded, however, that the claims are nonenabled because the specification
Page: Previous 1 2 3 4 5 6 7 8 9 10 Next
Last modified: November 3, 2007