Appeal No. 2001-1432 Page 3
Application No. 08/469,416
variations’ of the assays and methods recited in claims 1-16 of the ‘058 patent” (Brief,
page 13), none of which requires a nucleic acid probe of any kind, let alone a probe
capable of recognizing a single base difference within a restriction site of an oncogene
or its corresponding proto-oncogene. Further, we see nothing in Wallace’s study of the
thermal stability of single base pair mismatches which would have led one skilled in the
art to generate probes with the required functional characteristics.
Accordingly, we reverse the rejection of claims 93, 99 and 100 under the doctrine
of obviousness-type double patenting.
NEW GROUND OF REJECTION
Written Description
Under the provisions of 37 CFR § 1.196(b), we make the following new ground of
rejection: Claim 93 is rejected under the first paragraph of 35 U.S.C. § 112 as lacking
an adequate written description of the claimed invention.
In Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568,
43 USPQ2d 1398, 1406 (Fed. Cir, 1997) (citation omitted), the court stated that,
In claims to genetic material, [ ] a generic statement such as “vertebrate
insulin cDNA” or “mammalian insulin cDNA,” without more, is not an
adequate written description of the genus because it does not distinguish
the claimed genus from others, except by function. It does not specifically
define any of the genes that fall within its definition. . . . One skilled in the
art therefore cannot, as one can do with a fully described genus, visualize
or recognize the identity of the members of the genus. A definition by
function . . . does not suffice to define the genus because it is only an
indication of what the gene does, rather than what it is. [ ] It is only a
definition of a useful result rather than a definition of what achieves that
result.
The court recently clarified this position, emphasizing that “[not] all functional
descriptions of genetic material fail to meet the written description requirement,” for
example, “the written description requirement would be met for [a claim] . . . if the
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