specification indicates Engvall never conveyed any concern with the magnitude of the affinity of the
monoclonals and antigens used.
On the other hand, Engvall did have concern for the specificity of the monoclonals. Indeed,
the reason stated in the specification for employing monoclonals in her assays was the high specificity
of the these antibodies. Engvall Application 06/539,754, specification, p. 4, lines 13 to 25.
Engvall's specification begins by identifying that the technological field of the invention is
sandwich assays involving the use of two antibodies which are active against the same antigen:
[T]he present invention relates to a method for the determination of
an antigen (I) in solution, in which determination said antigen (I) is
reacted with an antibody (II), which is directed against the antigen (I)
and with an antibody (III), which is directed against the antigen (I)
and is labeled with an analytically indicatable atom or group and is
soluble in the liquid in the presence of which the determination is
carried out, to the formation of a conjugate comprising said antigen
(I) and said antibodies (II) and (III), which conjugate is insoluble or
is made insoluble, whereafter the analytically indicatable atom or
group is determined in the insoluble or insolubilized conjugate and/or
in the solution.
Engvall Application 06/539,754, specification, p. 1, lines 3-14. The specification goes on to indicate
that assay methods using biospecific affinity reactions are well known. At page 2, lines 1-11, of her
specification Engvall states:
A great number of assay methods involving biospecific affinity
reactions [are] known in which methods a first immunochemical
reactant is reacted with a second immunochemical reactant exhibiting
biospecific affin[ity] to said first reactant and then a third
immunochemical reactant, which exhibits biospecific affinity to the
first or the . . . second reactant (i.e., is an immunochemical
counterpart to the first or the second reactant) is reacted with its
counterpart to the formation of a conjugate comprising said first,
second and third reactants, one of said reactants being labeled with an
analytically indicatable atom or group of atoms.
Engvall further notes that in order to determine the presence of the second reactant, the
labeled conjugate must be separated from the labeled but unreacted component. She indicates that
this is commonly done by using, as one of the reactants, a component bound to an insoluble polymer.
The labeled conjugate is removed by simply removing the polymer with the bound conjugate from
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