Appeal No. 2003-1469 Page 9
Application No. 08/479,886
provided for assessing affinity (top of page 6 of the Brief). It is not
disputed that the instant specification provides these elements,
however, this is not the type of guidance that is lacking and which is
necessary for practicing the invention as claimed.
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 is not
predictable. 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, does not 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. Such experimentation would 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
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