Appeal No. 2000-1930 Page 4
Application No. 08/232,452
Miller is cited by the rejection for teaching retrovirus-mediated gene
transfer and expression in diploid human fibroblasts, where upon re-implantation,
a protein product is provided to the patient. Anson is cited for its demonstration
of the secretion of factor IX from human fibroblasts after retrovirus-mediated
gene transfer, and for its teaching that the fibroblasts may be reintroduced to the
patient by subcutaneous injection or as part of a full thickness skin equivalent
structure. Finally, Palmer is cited for disclosing the use of retrovirus-mediated
gene transfer of the adenosine deaminase gene in human diploid fibroblasts,
and also for teaching that the fibroblasts may be reintroduced to the patient by
subcutaneous injection or as part of a full thickness skin equivalent structure.
The rejection concedes that “[n]one of the above three references teaches the
reintroduction of genetically modified fibroblasts by implantation of a collagen
matrix containing said cells into the loose connective tissue of the dermis.”
Examiner’s Answer, page 4.
Garver I and II are cited by the examiner for teaching mouse fibroblasts
that have been genetically modified to express human a1-antitrypsin, and their
implantation into mice. Garver II is also cited for its teaching that as the
a1-antitrypsin was secreted into the bloodstream, “gene therapy need not target
the cell type that normally produces the protein of interest.” Id. at 6. Selden is
cited for its disclosure of genetically modified fibroblasts that secrete human
growth hormone, and their implantation into mice. Again, the examiner admits
that “[n]one of the above three references teaches the reintroduction of
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