Appeal No. 2001-1651 Page 10
Application No. 09/238,972
the examiner failed to provide the evidence necessary to establish that
appellant’s specification does not support appellant’s claimed invention.
To emphasize the inconsistent approach taken by the examiner, we note
that claim 17 is drawn to an antisense CAT2 oligonucleotide having the
sequence set forth in SEQ. ID. NO.: 2; and claim 2 is drawn to a method of using
an antisense CAT2 oligonucleotide having the sequence set forth in SEQ. ID.
NO.: 2. Notwithstanding the examiner’s finding that the specification enables a
method of inhibiting CAT2 expression using an antisense oligonucleotide
consisting of SEQ ID NO.: 2, the examiner excludes claim 17 from the rejection,
but includes claim 2 in the rejection.
In addition, we recognize the examiner’s reliance on Rojanasakul (Answer
page 7), which according to the examiner “gives evidence that the use of
antisense oligonucleotides in vivo caused renal failure due to toxicity of the
antisense oligonucleotide which could be due to nonspecific effects of the oligo
itself….” The examiner, however, appears to confuse the requirements under
the law for obtaining a patent with the requirements for obtaining government
approval to market a particular drug for human consumption. See Scott v.
Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994) (“Testing
for the full safety and effectiveness of a prosthetic device is more properly left to
the Food and Drug Administration (FDA). Title 35 does not demand that such
human testing occur within the confines of Patent and Trademark Office (PTO)
proceedings”).
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