Appeal No. 2004-1761 Page 16
Application No. 10/044,807
Here, there is no evidence of record showing that any of the seven
polymorphisms disclosed to exist in SEQ ID NO:1 occur in the recognition site of a
restriction endonuclease, as required in order for them to be useful in RFLP analysis.
Appellants have not pointed to any specific restriction enzyme that cuts or fails to cut at
a specific position in SEQ ID NO:1 depending on the presence or absence of a specific
polymorphism. Thus, the evidence of record does not support the asserted utility of
SEQ ID NO:1 in RFLP analysis.
Appellants also argue that the claimed nucleic acids are useful in “gene chip”
methods of tracking gene expression, and that “[e]xpression profiling does not require a
knowledge of the function of the particular nucleic acid on the chip.” Appeal Brief, page
12. See also page 11:
Such “DNA chips” clearly have utility, as evidenced by hundreds of issued
U.S. Patents. . . . Clearly, compositions that enhance the utility of such
DNA gene chips, such as the presently claimed nucleotide sequences,
must in themselves be useful.
Appellants argue that, in addition to their use in “DNA chips”, the claimed
sequences also have “utility in mapping the protein encoding regions of the
corresponding human chromosome, specifically chromosome 9.” Id., page 10.
Appellants also argue that
[t]he presently claimed polynucleotide sequence provides biologically
validated empirical data (e.g., showing which sequences are transcribed,
spliced, and polyadenylated) that specifically defines that portion of the
corresponding genomic locus that actually encodes exon sequence.
Id., pages 10-11. Appellants argue that “the described sequences are useful for
functionally defining exon splice-junctions,” id., page 11, and that “the practical scientific
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