Appeal No. 2003-1668 Page 9
Application No. 08/479,883
The examiner’s main concern seems to be that the effect of a given
mutation, or set of mutations, on the biological activity of a given protein can be
unpredictable. Thus, making and using the full range of variants encompassed
by the claims will require those skilled in the art to make such variants and to test
them to see which have the desired properties.
This concern, however, is not sufficient to support the instant rejection.
Appellants have disclosed those parts of the growth hormone molecule that are
relevant for receptor binding, have identified structurally related proteins that
would be expected to behave similarly, have suggested which types of mutations
in which sites would be expected to provide the desired function, and have made
exemplary mutations to support these disclosures. Thus, while practicing the
invention will undoubtedly require some experimentation, that experimentation
appears to be of a routine nature and Appellants have provided those skilled in
the art with substantial guidance regarding the direction in which the
experimentation should proceed. The experimentation required, therefore, does
not appear to be undue. See, e.g., PPG Indus. Inc. v. Guardian Indus. Corp, 75
F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996): “[A] considerable
amount of experimentation is permissible, if it is merely routine, or if the
specification in question provides a reasonable amount of guidance with respect
to the direction in which the experimentation should proceed” (quoting Ex parte
Jackson, 217 USPQ 804, 807 (POBA 1982)).
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