Appeal No. 2006-1035 Page 3
Application No. 09/925,140
The rejections on appeal focus on part (b) of the claim: polynucleotides encoding
“a polypeptide comprising a naturally occurring amino acid sequence at least 90%
identical to the amino acid [sequence] of SEQ ID NO:1.”
2. Enablement
The examiner rejected claims 3-7, 9, 11, and 12 under 35 U.S.C. § 112, first
paragraph, on the basis that the specification does not provide an enabling disclosure
with respect to polynucleotides encoding an amino acid sequence at least 90% identical
to SEQ ID NO:1. See the Examiner’s Answer, pages 3-4. The examiner noted that
claim 3 is not limited to polynucleotides encoding polypeptides that have the activity
disclosed in the specification for SEQ ID NO:1. Id., page 4.
The examiner reasoned that “even a small difference between sequences could
render substantial differences between the activities of the proteins.” Id., page 5. As
supporting evidence, the examiner cited:
• Burgess,1 as teaching that “the replacement of a single lysine at position 118
of the acidic fibroblast growth factor by a glutamic acid led to a substantial
loss of . . . biological activity”;
• Lazar,2 as teaching that the activity of TGF-α was not affected by replacing
the aspartic acid at position 47 with asparagine, but replacing it with serine or
glutamic acid sharply reduced biological activity;
• Schwartz,3 as teaching that “[r]eplacement of the histidine at position 10 of
the B-chain of human insulin with aspartic acid converts the molecule into a
superagonist”; and
1 Burgess et al., “Possible dissociation of the heparin-binding and mitogenic activities of heparin-binding
(acidic fibroblast) growth factor-1 from its receptor-binding activities by site-directed mutagenesis of a
single lysine residue,” Journal of Cell Biology, Vol. 111, pp. 2129-2138 (1990)
2 Lazar et al., “Transforming growth factor α: Mutation of aspartic acid 47 and leucine 48 results in
different biological activities,” Molecular and Cellular Biology, Vol. 8, pp. 1247-1252 (1988)
3 Schwartz et al., “A superactive insulin: [B10-Aspartic acid]insulin (human),” Proc. Natl. Acad. Sci. USA,
Vol. 84, pp. 6408-6411 (1987)
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