Appeal No. 96-2137
Application 07/668,920
1. Neoplastic tissue.
As presently drafted, claim 18 makes reference to neoplastic tissue at least three
times. First, the preamble of claim 18 indicates that neoplastic tissue in a mammal is
being measured. Second, the antibody used in the claimed method must bind to
insoluble intracellular antigens of necrotic neoplastic tissue. Third, that antibody does
not substantially bind to living neoplastic tissue.
It appears from the disclosure of this application that the neoplastic tissue to be
measured can differ, e.g., tumor type or source, from the necrotic neoplastic tissue and
living neoplastic tissue used to define the differential binding ability of the claimed
antibody. What is not clear is whether the necrotic neoplastic tissue and the living
neoplastic tissue used to define the differential binding ability of the claimed antibody
must be from the same tissue source or tumor or whether these materials can be from
different tissue sources or tumors. This is an open question since the wording of the
first clause of claim 18, in defining the differential binding ability of the antibody, does
not require that the necrotic neoplastic tissue originate from the living neoplastic tissue.
Clarification of this ambiguity is required.
2. Binding of the antibody.
As set forth above, the first clause of claim 18 requires the use of an antibody
that exhibits a differential binding ability in that the antibody must bind to insoluble
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