Appeal No. 1999-1510
Application No. 08/447,997
in vitro results i n expression of the proliferation-promoting gene,
thereby permitting cell proliferation in vitro.
Pages 15-16. Thus, the in vitro culture conditions can be manipulated to “turn
on” the regulatable promoter controlling the proliferation-promoting gene, thereby
expanding the cell population. When the cells are implanted in vivo, the signal
that activates transcription from the regulatable promoter is removed, the
proliferation-promoting gene is no longer expressed, and the cells stop dividing.
The claims are directed to compositions and methods representing a
specific embodiment of this general approach. In all of the claims on appeal, the
proliferation-promoting gene is under the control of the Mx-1 interferon-inducible
promoter.
Discussion
1. The indefiniteness rejection
The examiner rejected all of the claims under 35 U.S.C. § 112, second
paragraph, as indefinite. The examiner stated that
[n]one of claims 32-43 indicate any characteristic phenotype for the
cells nor the transgenic non-human animals. Induction to
proliferate is not a phenotype nor is it apparent that induction to
proliferate is a genotype nor does the application as filed define
induction to proliferate as a phenotype or genotype. . . . None of
claims 32-43 indicate any characteristic phenotype and therefore of
the genotype for the cells nor the transgenic nonhuman mammals.
Examiner’s Answer, page 4.
Appellants argue that
it is not necessary for patentability that the cells or transgenic
mammals differ in phenotype – it is sufficient that they differ in
genotype from the cells or mammals found in nature. . . . Here, the
claimed cells or transgenics clearly require a genotypic change –
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