Appeal No. 2003-2084 Page 9
Application No. 08/241,061
3. A method for identifying a crosstalk inhibitor for a ligand analogue conjugate,
wherein said ligand analogue conjugate comprises a binding site attached via a linkage
site to a protein, polypeptide or label, and wherein said crosstalk inhibitor competes with
said linkage site for binding to a ligand receptor, wherein said ligand receptor is an
antibody which binds said linkage site, said method comprising the steps of:
(a) making a potential crosstalk inhibitor comprising at least one analogue of a
linkage site of a ligand analogue conjugate,
(b) testing said potential crosstalk inhibitor by:
(i) performing a first assay utilizing a first reaction mixture comprising said
ligand analogue conjugate and a ligand receptor, wherein said ligand
receptor binds said linkage site causing a false positive result;
(ii) performing a second assay utilizing a second reaction mixture
comprising said ligand analogue conjugate, said potential crosstalk
inhibitor and said ligand receptor;
(iii) comparing the results of said first assay and said second assay, so
that no false positive result or a reduced false positive result in said
second assay indicates that said potential crosstalk inhibitor is useful
crosstalk inhibitor.
As seen from claim 3 of the '524 patent, the USPTO has already determined that
a method for identifying crosstalk inhibitors of the present invention is patentable
subject matter. The present enablement rejection questions whether one skilled in the
art would be able to identify crosstalk inhibitors without undue experimentation. It
appears that the USPTO has already answered that question in the affirmative by
issuing claim 3 of the '524 patent.
Furthermore, the examiner's analysis does not take into account the starting
point of a crosstalk inhibitor, i.e., knowledge of the linkage site which is part of the
ligand analogue conjugate. Development of a crosstalk inhibitor of the present
invention does not begin in a vacuum. Rather, the skilled artisan must start with
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