Appeal No. 2004-0005 Page 3
Application No. 07/644,361
Background
c-erbB-2 is a cell-surface oncogene, the amplification of which indicates a very
poor clinical prognosis, especially in breast and ovarian cancer. Specification, page 2,
lines 11-27. The present invention is directed toward a drug combination which
comprises an anti-neoplastic agent and a molecule that binds c-erbB-2 protein on tumor
cells. The molecule that binds c-erbB-2 protein must not be conjugated to the anti-
neoplastic agent and must induce an increase in the phosphorylation of c-erbB-2 protein
when placed in contact with the tumor cells. Claim 1.
The molecule required by claim 1 on appeal is defined in the specification as
follows:
A molecule that binds tumor cells for the purposes of the inventions
herein is one that is reactive with the c-erbB-2 protein. By ‘reactive’ it is
meant that the molecule binds the c-erbB-2 protein as measured or
determined by standard ligand-receptor binding assays, for example,
competitive binding assays or saturation assays or standard
immunoassays such as ELISA or RIA.
Specification, page 14, 2nd paragraph. Preferred molecules are stated to be
monoclonal antibodies that bind to the c-erbB-2 protein. Id., page 16, lines 25-28. A
preferred monoclonal antibody is denominated TAb 250. See, e.g., id., page 16, line 25
- page 17, line 2 and claim 9.
Example 8D of the present specification sets forth work stated to establish that
TAb 250 induces an increase in the phosphorylation of c-erbB-2 protein when placed in
contact with tumor cells expressing c-erbB-2. Specifically, SKBR3 cells were labeled
with 32p-orthophosphate and then incubated with TAb 250. Lysates were centrifuged
and immunoprecipations carried out using a polyclonal anti-peptide directed against the
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