Appeal No. 2002-0091 Page 6
Application No. 08/479,884
practicing the full scope of the claims would not have required undue
experimentation.
The examiner bears the initial burden of showing nonenablement. See In re
Wright, 999 F.2d 1557, 1561-62, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
“[E]nablement requires that the specification teach those in the art to make and
use the invention without ‘undue experimentation.’ . . . That some experimentation
may be required is not fatal; the issue is whether the amount of experimentation
required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444
(Fed. Cir. 1991) (emphasis in original). Some experimentation, even a
considerable amount, is not “undue” if, e.g., it is merely routine, or if the
specification provides a reasonable amount of guidance as to the direction in which
the experimentation should proceed. See In re Wands, 858 F.2d 731, 737, 8
USPQ2d 1400, 1404 (Fed. Cir. 1988).
In this case, the examiner has not adequately shown that practicing the full
scope of the claims would have required undue experimentation. The examiner
correctly notes that the open claim language of claim 88 encompasses a vast
number of potential hGH variants. See the Examiner’s Answer, page 7.2 We also
agree with the examiner’s position that the effect of any single amino acid
substitution cannot be precisely predicted in advance.
2 The examiner’s calculation of 5319 single-position substitutions alone, however, is incorrect. The
actual number of single-substitution variants is 1007: each of 53 positions can be substituted with
any of 19 amino acids; 53 x 19 = 1007. Since we’re only counting single-position mutants, only one
position can be changed in any given variant. The examiner’s calculation appears to be more in
line with the number of mutants having mutations in any or all of the recited positions, but even
there, the correct number would be 1953, not 5319.
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