Appeal No. 2005-0731 Page 17
Application No. 09/974,712
polynucleotides (or a part of it) to a solid substrate, in combination with other
polynucleotides, to form a DNA chip, and 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 gene comprising SEQ ID NO:1 in any practical way. The specification provides no
guidance regarding what the SEQ ID NO:1-specific information derived from a DNA chip
would mean.
For example, assume 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 what, if anything, that result
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
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