Appeal No. 2004-2319 Page 7
Application No. 09/915,694
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).
The examiner argues that “[t]he recitation of ‘naturally occurring amino
acid sequence’ in the claims does not meet the enablement requirement since
the specification must still provide guidance regarding the specific amino acid
residues in the amino acid sequence of SEQ ID NO: 1 which cannot be changed
and amino acid residues which can be changed but still retain malate
dehydrogenase.” Examiner’s Answer, page 14. That argument is not agreed
with because the examiner has not explained and/or provided evidence why a
naturally occurring polynucleotide sequence that is at least 95% identical to the
polynucleotide sequence of SEQ ID NO: 2, or a naturally occurring polypeptide
that is at least 95% identical to the amino acid sequence of SEQ ID NO: 1 would
not have malate dehydrogenase activity. As explained by appellants, “through
the process of natural selection, nature will have determined the appropriate
amino acid sequences.” Thus, the rejection of claims 3, 6, 7, 9 and 12 under 35
U.S.C. § 112, first paragraph, for lack of enablement, is reversed.
NEW GROUND OF REJECTION
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