Appeal No. 2004-2319 Page 6
Application No. 09/915,694
specific structural /catalytic amino acids and the structural motifs essential for
protein activity/function which cannot be altered.” Id. The rejection asserts
further that
The amount of experimentation to make the claimed polynucleotide
is enormous and undue and entails selecting specific nucleotides to
change (deletion insertion, substitution, or combinations thereof) in
any polynucleotide to make a polynucleotide encoding a
polypeptide comprising an amino acid sequence that is at least
95% identical to SEQ ID NO: 1 or selecting specific nucleotides to
change (deletion, insertion, substitution, or combinations thereof) in
the nucleotide sequence of SEQ ID NO: 2 to make a polynucleotide
that has a nucleotide sequence that is at least 95% identical to
SEQ ID NO: 2 and determining by assays whether the encoded
polypeptide has malate dehydrogenase activity.
Id. at 5.
Appellants argue that “[i]ndependent claim 3 recites not only that the
‘variant’ polynucleotides encode polypeptides that are at least 95% identical to
SEQ ID NO: 1, but also have ‘a naturally occurring amino acid sequence.’”
Appeal Brief, page 10 (emphasis in original). Thus, appellants contend, “through
the process of natural selection, nature will have determined the appropriate
amino acid sequences,” and given the information provided by SEQ ID NO: 1,
the specification enables one skilled in the art to obtain a polynucleotide
encoding a polypeptide comprising a naturally-occurring amino acid sequence at
least 95% identical to the amino acid sequence of SEQ ID NO: 1. We agree.
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
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007