Appeal No. 2004-1040 Page 19
Application No. 09/770,643
means. Perhaps a change in expression of the gene would mean different things,
depending 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),
or the degree of increase? Because the specification provides no information about the
activity of the protein encoded by SEQ ID NO:1, it provides no guidance as to how to
interpret the results of a DNA chip-based gene expression assay based on the claimed
polynucleotides.
The same problem afflicts Appellants’ assertions that the claimed polynucleotides
can be used to map a particular chromosomal locus or to define the exon splice-
junctions of the genomic gene: the specification provides no meaningful guidance
regarding how to use such information in any practical way. What would it mean, for
example, if SEQ ID NO:1 hybridizes to a specific part of human chromosome 2, or if
SEQ ID NO:1 can be used to show that the chromosomal gene has an exon splice
junction between nucleotides 103 and 104? The specification provides no guidance on
how such information would allow those skilled in the art to use the claimed
polynucleotides in a specific, substantial way. By contrast, if the specification disclosed,
for example, that SEQ ID NO:1 hybridized adjacent to a chromosomal locus associated
with a known disease (e.g., a locus susceptible to a cancer-causing translocation), the
sequence would have an apparent utility in disease diagnosis. However, without
disclosure of a specific use for the resulting data, using the claimed sequences for
mapping or determining exon splice-junctions amounts to research on the claimed
polynucleotides themselves.
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