Appeal No. 2001-2401
Application 08/277,225
It is the examiner’s position that (Answer, pages 3-4):
Pollema et al teach a sequential immunoassay for the investigation
of a short-time kinetic study of antibody binding. Pollema et al teach
using immunomagnetic beads as the solid phase surface which are
coated with antibodies against the protein to be detected. ... The beads
are packed into a reaction coil to form an immobilized reaction surface.
Next, labeled protein is aspirated into the reaction coil, and the flow is
stopped for a specified contact time. .... Following the stopped flow,
unbound portion of the sample is measured to determine the amount of
unbound labeled reagent present. this yield signal which can be related
to the protein concentration. Pollema et al. tech a competitive binding
reaction of a serum sample by ?spiking” an unlabeled antibody with a
known quantity of an identical FITC-labeled antibody. first the beads are
placed into a magnetic field and held, next the spiked sample is
introduced into the beads. ... This competitive assay is optimized if there
is a slight excess of labeled antibodies for the sites available. Pollema
also teach that in a sandwich assay, an excess of both labeled and
unlabeled antibodies are used to drive the reaction to the maximum
bound state. ...
The examiner finds that (Answer, page 5):
Pollema et al differ from the instant invention in failing to
specifically teach the steps of the competitive and sandwich
immunoassays, and measuring the bound label as an indication of the
amount of analyte present in the sample.
To remedy the deficiencies of Pollema, the examiner relies on Friguet.
According to the examiner, Friguet teaches “an enzyme-linked immunosorbent assay
involving mixing antigen (analyte) with an antigen-specific antibody (second ligand),
contacting the resulting mixture with a solid phase coated with the antigen (first ligand),
binding a detectable tag (a second antibody) to the antigen-specific antibody, and
detecting the portion of the tag bound to the solid phase (bound to the first
ligand/second ligand complexes to the solid phase)”. Answer, page 5. Friguet
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