Appeal No. 2001-2379 Page 3
Application No. 08/931,666
The specification discloses an “approach for the targeting of an
intracellular protein which is based on the discovery that cationized proteins are
not necessarily sequestered in intracellular vesicles when taken up by a cell.”
Page 3. The disclosed method is “based on the discovery that a cationized
antibody specific for the HIV-1[-]encoded Tat protein effectively inhibits
replication of the HIV-1 virus when taken up by infected cells. . . . If the
cationized anti-Tat antibody were sequestered in intracellular vesicles, as the
prior art suggested, the antibodies would not come to contact with the Tat protein
which is produced in the cytoplasm and transported into the nucleus.” Id. The
specification provides examples showing that cationized anti-Tat monoclonal
antibodies counteracted the growth inhibitory effect of exogenous Tat on
lymphocytes in vitro. See pages 14-19.
Discussion
The claims are directed to a method of targeting an intracellular protein
such as the HIV-1 Tat transactivating factor, by contacting the cell with a
cationized antibody. The examiner rejected the claims as nonenabled and as
obvious.
1. Enablement
The examiner rejected the claimed methods as nonenabled, on the basis
that the “evidence is not sufficient to allow one skilled in the art to make and use
the claimed invention with a reasonable expectation of success and without
undue experimentation.” Examiner’s Answer, page 4. The examiner noted that
Appellant had provided only in vitro data to support the claimed method, and had
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