Appeal No. 2003-1817 Page 3
Application No. 09/501,714
judicially created doctrine of obviousness-type double patenting over the claims of U.S.
Patent Nos. 5,922,567 or 6,001,598. We reverse the written description rejection and
affirm the obviousness rejection and obviousness-type double patenting rejections. In
addition, we make a new ground of rejection under 37 CFR § 1.196(b).
Discussion
1. Written description.
The examiner considers that claims 45, 47-49, 52, 54-56 and 66-68 do not
comply with the written description requirement of 35 U.S.C. § 112, first paragraph,
since:
Allelic variants are alternate forms of a gene which have at least one
mutation in the nucleotide sequence which may result in mRNAs
(polypeptides) with altered function. With regard to a naturally-occurring
human polynucleotide sequence variant, there is no description in the
specification of any mutational site that exist in nature, and there is no
description of how the structure of SEQ ID NOs: 2 or 4 relates to the
structure of any allele including strictly neutral alleles. The general
knowledge in the art concerning alleles does not provide any indication of
how the structure of one allele is representative of unknown alleles. The
nature of alleles is that they are variant structures, and in the present state
of the art the structure of one does not provide guidance to the structure of
others.
Examiner’s Answer, page 6.
The Federal Circuit discussed the application of the written description
requirement to inventions in the field of biotechnology in University of California v. Eli
Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997), stating
that “[a] written description of an invention involving a chemical genus, like a description
of a chemical species, ‘requires a precise definition, such as by structure, formula, [or]
chemical name,’ of the claimed subject matter sufficient to distinguish it from other
materials” Id. at 1567, 43 USPQ2d at 1405. The court also stated that
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