Appeal No. 2006-1608 Page 4
Application No. 09/978,593
be that “the use of in vitro tests is not an acceptable predicator of in vivo activity
when claiming treatments to HIV.” Examiner’s Answer, page 6.
According to the examiner, the “[c]haracteristics of a compound’s activity
in vitro using purified or partially purified components generally differs
significantly with the compound when used in a living body.” Id. at 3. The
examiner asserts that clinical correlation of in vitro activity to in vivo efficacy is
generally lacking, as cultured cell lines “differ significantly from in vivo animal
models.” Id. at 4.
Moreover, as explained by the examiner, “[t]he greatly increased
complexity of the in vivo environment as compared to the very narrowly defined
and controlled conditions of an in vitro assay does not permit a single
extrapolation of in vitro assays to human diagnostic efficacy with any reasonable
degree of predictability.” Id. The examiner cites Planchon,3 Kerr4 and
Chomienne5 to demonstrate the lack of correlation of in vitro testing to in vivo
efficacy. See id. at 5. The examiner then cites a statement by Joanne
Shellenbach, a spokeswoman for the American Cancer Society, quoted in the
3 Planchon et al. (Planchon), “Differential Effects of Butyrate Derivatives on Human Breast
Cancer Cells Grown as Organotypic Nodules in Vitro and as Xenografts in Vivo,” In Vivo, Vol. 6,
pp. 605-10 (1992).
4 Kerr et al. (Kerr), “The relationship between Cytotoxic Drug Exposure and Tumour Cell Kill, in
Vitro and in Vivo,” In Vivo, Vol. 5, pp. 385-88 (1991).
5 Chomienne et al. (Chomienne), “Discrepancy Between in Vitro and in Vivo Passaged U-937
Human Leukemic Cells: Tumorigenicity and Sensitivity to Differentiating Drugs, “ In Vivo, Vol. 2,
pp. 281-88 (1988).
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