Appeal No. 1997-2532
Application No. 08/427,569
isolates suggests that diagnostic assays should be useful in detection [sic, detecting]
virtually all substrains of the virus. The positions of sequence variation outlined here should
assist in the design of future diagnostic reagents.' " (answer, p. 6). Thus, the dispositive
issue is whether the "methodology of selection" of Ratner or Hogan (or any other applied
prior art reference) discloses or suggests the claimed synthetic oligonucleotides
comprising a first segment selected from SEQ ID NOs. 6-41 and from SEQ ID NOs. 42-53
suitable for use as amplifier and capture probes, respectively, in a solution sandwich
hybridization assay for HTLV-1.
First, we note that neither appellants nor the examiner appear to appreciate that
Hogan is directed to nucleic acid probes for non-viral organisms based on unique rRNA
sequences (see e.g., p. 3, ll. 22-30) found in 5S rRNA, 16S rRNA and 23S rRNA (see e.g.,
p. 9; claim 5). Hogan expressly states, "With the exception of viruses, all prokaryotic
organisms contain rRNA molecules including 5S rRNA, 16S rRNA, and a larger rRNA
molecule known as 23S rRNA" (emphasis added, p. 9, ll. 5-8). There is no evidence of
record establishing that HTLV-1 contains 5S rRNA, 16S rRNA and/or 23S rRNA. The
examiner has not provided any fact-based or reasoned explanation of why one of ordinary
skill in the art would have looked to Hogan's method of selecting non-viral probes for
detecting non-viral organisms for guidance in selecting viral nucleic acid probes for
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