Appeal No. 96-2137
Application 07/668,920
of the specification as follows:
[T]he antibody has been selected by screening a library of antibodies that
have been generated to insoluble intracellular antigen and selecting
those antibodies that are specific to insoluble intracellular antigen present
in both neoplastic and normal cells, but not to antigen released into the
general circulation upon cell death or to antigen on the exterior of living
cells.
The specification also describes the antigens to which the present antibodies
bind at page 7, lines 2-13, as follows:
Upon cell death and lysis in an animal, soluble components of the cell,
primarily from the cytoplasm, are released. The remainder of the necrotic
cell comprises a “cell ghost” made up of various generally insoluble
materials that remain “fixed” in situ in the tissue. The insoluble cell ghost
is gradually destroyed by phagocytosis and enzymatic degradation. At
least a portion of the cell ghost remains intact for as long as several
weeks. It has been discovered that certain intracellular cell ghost
constituents are antigenic. These antigens include nuclear antigens,
structural elements, and organelles.
The initial screening procedure used in the present invention in order to make a
first determination of antibodies which would be candidates for use in the present
invention is described at page 8, lines 15-32, of the specification as follows:
In order to screen for monoclonal antibodies that bind specifically to cell
ghosts with little or no binding to live cells, equal aliquots of normal and
neoplastic live cells are prepared. To obtain cell ghosts, one aliquot each
of neoplastic and normal cells is subjected to several rapid freeze-thaw
cycles, and is then washed with buffer to remove soluble components.
The ability of monoclonal antibody from each tested culture to bind,
respectively, the cell ghosts and the intact cells is then quantitatively
measured. One appropriate measurement technique is a
radioimmunoassay. Thus, when using murine monoclonal antibody,
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