Appeal No. 2003-2017 Page 17
Application No. 09/802,116
We are not persuaded by Appellants’ argument. We find that the asserted
uses of the claimed polynucleotides—as a component of a DNA chip for
monitoring gene expression, as a marker for a given chromosomal locus, or for
defining the exon splice-junctions of a gene—do not satisfy the utility requirement
of § 101. Such uses do not provide a specific benefit in currently available form.
For example, with regard to the asserted “DNA chip” utility, we accept for
argument’s sake that a person skilled in the art could attach one of the claimed
polynucleotides (or a part of it) to a solid substrate, in combination with other
polynucleotides, to form a DNA chip. We can also accept that such a DNA chip
could be used to monitor changes in expression of the corresponding gene.
However, the specification provides no guidance to allow a skilled artisan to use
data relating to the expression of the putative KIP gene in any practical way. The
specification provides no guidance regarding what the KIP gene-specific
information derived from a DNA chip would mean.
Assume, for example, that a fragment of SEQ ID NO:1 was attached to a
DNA chip and the researcher observed that expression of the corresponding
gene was increased when a cell was treated with a particular agent. The
specification provides no basis on which a skilled worker would be able to
determine whether that result is meaningful. Maybe the meaning in a change in
expression of the gene would depend on other factors, but again the specification
provides no hint what other factors might be important. Would it depend on what
agent is used, what cell type is used, the behavior of other genes (if so, which
genes and what behavior is significant), the degree of increase? Because the
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