the improvement comprising employing monoclonal antibodies having
an affinity for the antigenic substance of at least about 10 liters/mole for each8
of said labeled antibody and said antibody bound to a solid carrier.
[Emphasis added.]
8 8 3
We interpret the limitation “10 liters/mole” to mean 1x10 liters/mole. The phrase “at least”
indicates that the stated value for the affinity constant is a minimum value. The effect of the word
“about” is to broaden the count to encompass values of the affinity constant somewhat lower than
8
1x10 liters/mole.
Prior to the invention of the subject matter of the count, immunometric or sandwich assays
used polyclonal antibodies. The improvement recited in the count resides partially in the substitution
of monoclonal antibodies for polyclonals. It also resides in the use of ?monoclonal antibodies having
an affinity for the antigenic substance of at least about 10 liters/mole for each of said labeled antibody8
and said antibody bound to a solid carrier.” Thus, the count does not encompass the use of all
monoclonal antibodies and their respective antigens. It is limited to the subgenus of monoclonals and
antigens having an affinity constant beginning at about 1 x 10 liters/mole and ranging up to infinity.8
In other words “about 10 liters per mole” sets the minimum of the affinity range.8
Engvall’s claims 1 to 45 and David’s claims 1 to 29 correspond to the sole count of this
interference.
3
To interpret this limitation any other way would render the limitation meaningless. In scientific
8 7 9
notation 5 X 10 may also be properly written as 50 X 10 or 0.5 X 10 .
2
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