contemporaneous recognition and appreciation that the affinity constants of antibodies 50/3, 73/3 and
73/8 were at least about 10 liters per mole at the time of the alleged reductions to practice in8
October, 1979, or prior to David’s filing date of August 4, 1980. Engvall, therefore, has not proved
an actual reduction to practice of an embodiment falling within the subject matter set out in the count
prior to David’s filing date.
Our discussion of Silvestri v. Grant at pages 45 to 47 of this opinion is relevant on this point
also. As we noted there, the requirement of the count, that both monoclonal antibodies have an
affinity constant of “at least about 10 liters/mole” is not merely superfluous extra information. It is8
a positive limitation which excludes subject matter from the scope of the count. It was necessary,
therefor, for Engvall to prove recognition and appreciation of the affinity constant limitation.
In her reply brief, Engvall argues for the first time that Bergland’s tests merely confirmed what
the Engvall inventors knew all along. Engvall Reply Brief, pp. 28-29. Engvall asserts (Engvall Reply
Brief, pp. 25-26):
Engvall has demonstrated conception of the use of high affinity
monoclonal antibodies in the Fall of 1978. Likewise, when Engvall’s
first successful sandwich assays were carried out in October 1979,
Engvall recognized and appreciated that high affinity antibodies, i.e.,
having affinities of at least about 10 liters per mole, had been used.8
More particularly, Engvall asserts that prior to the alleged actual reductions to practice in October,
1979, the inventors were looking for “high affinity” monoclonal antibodies comparable to the minimal
clinically required affinity for conventional anti-AFP polyclonals; that Dr. Uotila had compared
monoclonal antibodies including 50/3, 73/3, and 73/8 to conventional anti-AFP polyclonals and
believed they were of high affinity comparable to “conventional” polyclonal antibodies; and that the
inhibition assays run by Dr. Uotila told the inventors that antibodies 50/3, 73/3 and 73/8 had the
“requisite affinity.” In addition Dr. Engvall testified that in an assay that can detect antigen in
amounts of nanomoles per liter the affinity constants for the antibodies are going to be nanomoles per
liter. Engvall Reply Brief, pp. 26-28.
We view the above arguments, raised in Section II.B. of Engvall’s reply brief (pages 25-29),
to be new arguments. Such belated arguments do not give the opposing party adequate notice and
a fair opportunity to respond. Section 1.656(b) of 37 CFR requires that all arguments be presented
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