Appeal No. 1999-1330
Application No. 08/527,373
the claimed method which requires that the tumor cells have been transduced with a
polynucleotide encoding wild-type p53.
The examiner relies on Orkin as indicating the “importance of relevant animal
models” and as stating “that 'many mouse models often do not faithfully mimic the
relevant human conditions.'” (Answer, page 10). The examiner, additionally, notes the
statements of Orkin which are urged to establish that “the relevance of results from
animal models with respect to correlation of human treatment are even more
unpredictable ‘with respect to the efficiency of gene delivery and the host response to
viral vectors.’” (Answer, page 10).
The examiner, further, urges that (Answer, paragraph bridging pages 10-11):
[a]ppellants’ nude mouse model cancer system does not
measure or take into account the immune response that
would be generated in a human patient, for example, against
the adenoviral vector or any other viral vector embodied in
the claimed invention. Thus, a nude mouse model, where
the animal lacks T-cells to mount an effective immune
response, is not a representative animal model for
evaluating naturally occurring cancer regression in an
immunocompetent animal such as a human due to the
unpredictability of the immune reaction to the viral vector,
the unpredictability of generating a threshold protein
expression level in transduced cells, and the unknown effect
of the experimental system on naturally occurring cancers
which evaded immune detection in vivo.
The examiner concludes that (Answer, page 11):
in view of the quantity of experimentation necessary to
determine the treatment parameters for naturally occurring
5
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007