Appeal No. 2001-2401
Application 08/277,225
immunomagnetic beads to investigate short-time antibody binding. The SIA assay
format is entirely different from that of the claimed invention, as acknowledged by the
examiner on page 5 of the Answer. At first blush, the Pollema reference looks relevant
because of its emphasis on short-time binding kinetics, i.e., measuring analyte/antibody
binding in that limited window of time before non-selective binding and/or dissociation-
reassociation become a factor. According to Pollema, the stop flow techniques
described therein enhance the usefulness of the sequential injection 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. Pollema,
page 1391. In addition, Pollema suggests rather generically that the “technique is quite
flexible and should be adaptable to most of the detection schemes which have been
utilized for clinical immunoassays. Pollema, page 1356, column 2. However, reading
the reference in its entirety, it is clear that the “technique” to which Pollema refers here
is that of the steps of the “sequential injection immunoassay” and not any specific time
frame of the SIA technique. Interestingly, the entire SIA assay time of Pollema would
appear to be about 120 seconds. Pollema, page 1358, column 2.
Friguet is cited by the examiner for the disclosure of a competitive ELISA assay
which allows the determination of the dissociation constant of the antigen-monoclonal
antibody equilibrium in solution, provided it is used after the equilibrium is reached to
measure the amount of free antibody in solution. Friguet, page 306. Thus, the Friguet
assay must be conducted after equilibrium is reached. In contrast, the claimed
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