Appeal No. 2002-0870 Page 2
Application No. 09/208,206
Claims 6 and 23 stand rejected under the first paragraph of 35 U.S.C. § 112,
“because the specification, while being enabling for polypeptides that contain SEQ ID
NO: 2, does not reasonably provide enablement for all naturally occurring polypeptides
found in humans that have 90% sequence identity to SEQ ID NO:2.” Answer, page 3.
According to the examiner (id.),
[t]he instant application does not provide guidance for one of skill in the art
to obtain active or otherwise useful embodiments of the claimed invention
commensurate with the scope of the claims without performing undue
experimentation. For example, the number of insertion embodiments
alone that are 90% identical to SEQ ID NO:2 is 2.95 x 1042. Additionally,
there are approximately 3.38 x 1082 nucleotide sequences that encode the
amino acid sequence that is SEQ ID NO:2; thus yielding about 10120
nucleotide sequences that would encode amino acid sequences that are
at least 90% identical to SEQ ID NO:2. With this vast number of
sequence[s], there exist sequences that would not hybridize specifically to
any probe sequence disclosed in the instant application and that will not
be amplified in a PCR run by any set of primers disclosed in that instant
application and yet would encode either SEQ ID NO:2 or a polypeptide
sequence at least 90% similar to SEQ ID NO:2.
If we understand the examiner’s principal concern, it is that the claims are
extremely broad, and it is likely that the amplification and hybridization protocol
provided in the specification will fail to identify some polypeptides with naturally-
occurring sequences that are at least 90% identical to SEQ ID NO:2.
“The first paragraph of 35 U.S.C. § 112 requires, inter alia, that the specification
of a patent enable any person skilled in the art to which it pertains to make and use the
claimed invention. Although the statute does not say so, enablement requires that the
specification teach those in the art to make and use the invention without ‘undue
experimentation.’ In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir.
1988). That some experimentation may be required is not fatal; the issue is whether the
amount of experimentation is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d
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