Interference 104,066
22. Even if we were to assume, arguendo14 that Vogelstein’s broad claims encompass
methods of diagnosis and prophylaxis, we find that Lee does not explain how its
arguments are applicable to claims 12-22.15 That is, Lee does not explain how the
14 We find Lee’s arguments that all of Vogelstein’s claims designated as
corresponding to the count encompass non-therapeutic methods such as diagnosis and
prophylaxis to be unconvincing.
First, Lee urges that Dr. Harris’s declaration (paras. 36 and 38) supports its
position (LB, p. 17), that Vogelstein’s claims are directed to diagnostic and prophylactic
methods. However, in the referenced sections of the declaration, we find that Dr. Harris
discusses another application; i.e., the ‘661 Application, not the involved ‘366
Application. With respect to the involved application, Dr. Harris acknowledges that it
contains numerous changes including a teaching of a therapeutic use for a wild-type
p53 suppressor gene (paras. 39, 42 and 43). Moreover, for the most part, we find that
Dr. Harris’s declaration is directed to the ‘366 specification and not to the claims. We
do not find, and Lee has not pointed out, any statement in Dr. Harris declaration as to
what one of ordinary skill in the art would understand Vogelstein’s claims to
encompass.
Second, we have reviewed the involved ‘366 Application and find that all the
diagnostic methods described therein are DNA hybridization assays. That is, p53 DNA
is hybridized to the DNA obtained from a lysate of the cell line in question. We find no
methods of diagnosis in the involved ‘366 Application which comprise the step of
“supplying wild-type p53 gene function to a cell which has lost said gene function by
virtue of a mutation in a p53 gene.” Moreover, it is not clear to us, and Lee does not
explain, how supplying wild-type p53 to a cell which is known not to have said function
in a manner such that the p53 gene is expressed acts as a diagnostic assay.
Third, the involved ‘366 Application is devoid of any teachings with respect to the
use of p53 for prophylactic purposes. Lee has not provided any evidence that those of
ordinary skill in the art would understand that the methods described in Vogelstein’s
claims designated as corresponding to the count encompass prophylactic treatments.
Accordingly, we find Lee’s position with respect to Vogelstein’s claims encompassing
prophylactic methods to be argument of counsel. As discussed above, we accord
arguments of counsel little, or no, evidentiary weight. Meitzner v. Mindick, 549 F.2d at
782, 193 USPQ at 22.
15 Vogelstein’s claims 12-22 read as follows:
12. The method of claim 11 wherein the tumor cell is a colorectal tumor
cell.
13
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