Appeal No. 2001-1293 Page 2
Application No. 08/464,271
said method comprising administering to said organism an
amount of said latent toxin effective to trigger generation of said cell
toxin by enzymatic conversion of the latent toxin; thereby
selectively inhibiting growth or causing death of at least a
substantial portion of said tissue-type or cell line.
38. A method according to Claim 42 wherein said exogenous enzyme
is selected from non-mammalian enzymes that catalyze the
conversion of the latent toxin into a cell toxin for said cell line.
40. A method according to Claim 39 wherein said viral enzyme is
herpes simplex thymidine kinase.
The examiner relies on the following references:
Ledley, “Somatic gene therapy for human disease: Background and prospects.
Part I,” The Journal of Pediatrics, Vol. 110, pp. 1-8 (1987)
Kappel et al. (Kappel), ”Regulating gene expression in transgenic animals,”
Current Opinion in Biotechnology, Vol. 3, pp. 548-553 (1992)
Mullen, “Metabolic suicide genes in gene therapy,” Pharmac. Ther., Vol. 63, pp.
199-207 (1994)
Claims 3-8, 12, 29, 31-41, 44, and 45 stand rejected under 35 U.S.C.
§ 112, first paragraph, as nonenabled.
We affirm in part.
Background
The specification discloses a method of “establishing stable transgenic cell
populations and then selectively ablating (i.e., negatively selecting for) specific
cell types and/or cell lineages in such transgenic cell populations at desired
stages of development or differentiation.” Page 1.
According to the invention method, (C) cells that express
exogenous gene (G) and thus contain enzyme (E) within the
transgenic cell population, when exposed to a specific latent toxin,
i.e., non-toxic drug substance that enzyme (E) converts into a
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