Appeal No. 1996-2442
Application 08/062,021
On pages 5 and 6 of the Examiner’s Answer, the examiner establishes that many
of the individual process parameters and reagents required by the claims were known
in the art at the time of the invention:
Simultaneous amplification of two distinct viral target[s] and the motivation
to do so are taught by [Nedjar] . . . Primers directed to hCMV are taught
by [Brytting]. One critical element of the invention is the design of primers
which have the same range of melting temperature (Tm) and have Tm’s
within about 2°C or about 5°C of one another to allow all the primers to
function in the same amplification condition. This is taught in the multiplex
method by [Gibbs]. Indeed, [Gibbs] teach[es] that all the primers are
designed to conform to specific parameters regarding the melting
temperature . . . [Gibbs’] primers are found in the Tm range as specified in
the instant claims, i.e., between about 65°C to 74°C and within about 5°C
of one another . . .
Other elements of the invention including pH, the concentrations of
primers and DNA polymerase, length of primers, additional PCR reagents,
capturing probes, and water-insoluble supports are all taught in the prior
art.
In addition, according to the examiner, Chamberlain is newly cited to show that
“the use of two-temperature PCR and 10 units of DNA polymerase is taught in the prior
art” (Examiner’s Answer, page 13).
Without further analysis, the examiner concludes that “[i]t would have been prima
facie obvious to one of ordinary skill in the art at the time the instant invention was
made to incorporate the teachings presented above to develop the instant method to
simultaneously amplify and detect human CMV and other infectious agent[s] such as
HIV” (Examiner’s Answer, pages 4-5) and “[o]ne of ordinary skill in the art would have
reasonably [sic] to empirically determine the specified parameters or conditions claimed
. . . [i]n a time period where more diseases are found to be caused by bacterial or viral
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