Appeal No. 2001-2401
Application 08/277,225
teaches “mixing similar concentrations of analyte and antibody, and performing the
contacting step under conditions and for a time sufficiently limited that no readjustment
of the liquid phase equilibrium occurs during the step of contacting the mixture with the
solid phase”.... Id.
Woods is relied on by the examiner for the disclosure of “a method for
quantitatively determining the presence of a ligand in a sample in a sandwich
immunoassay” ... Id.
The examiner summarizes (Answer, pages 5-6)
It would have been obvious to one of ordinary skill in the art at the
time the invention was made to perform the assay of Friguet et al using
the sequential injection method and short contact time taught by Pollema
et al because Pollema et al teach that sequential injection offers several
advantages for immunoassays. The highly reproducible timing obtained
with the sequential injection allows for accurate analysis that can extend
into non-equilibrium measurements in a very short time frame not
generally considered or achieved by a batch technique. Sequential
injection accelerates sample handling, which in batch method is too slow
thus preventing the utilization of short-time kinetics. Stop-flow techniques
enhance the usefulness of immunoassay by allowing well-controlled
contact times between antibody and antigen, which can range from only a
fraction of a second into the traditional equilibrium time frame.
The examiner also finds the fact that the contacting step in Pollema is inherently
“performed for a time so that equilibrium is not reached and the binding curve does not
level off”.... Answer, page 6.
We do not find the examiner has presented sufficient evidence to support a
prima facie case of obviousness.
Pollema teaches a sequential injection immunoassay (SIA) which utilizes
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