Appeal No. 2007-0056 Page 4
Application No. 09/906,511
mixture. According to this embodiment the sensitized particles comprise carrier
particles having a binding partner for the analyte immobilized on the particles.
In the alternative, a second embodiment requires the mixing of a sample
comprising an unknown concentration of analyte with a known concentration of
the binding partner and a known amount of sensitized particles in an assay
medium to form a second reaction mixture. According to this embodiment the
sensitized particles comprise carrier particles having the analyte of interest
immobilized on the particles.
The second step requires the first or second reaction mixture be incubated
under conditions allowing the formation of an aggregation reaction mixture. As a
result of the interaction between the analyte and the binding partner during
incubation, different sized aggregates are formed. Accordingly, this step requires
that the aggregation reaction mixture comprise the sensitized particles and
different sized aggregates thereof.
The third step requires the size distribution of the sensitized particles and
different sized aggregates thereof contained in the reaction mixture be
determined by polarization intensity differential scattering (PIDS).
The last step requires the concentration of the analyte in the sample be
determined using the distribution of the sensitized particles and the different
sized aggregates.
According to the examiner, “Kosako teach[es] a method of analyzing
particle size distributions in antigen-antibody binding assays.” Answer, page 4.
In this regard, the examiner finds Kosako discloses that “[a]ntibodies or antigens
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