Interference No. 103,906
paragraph of 35 U.S.C. § 112.
According to Dionne (DRB 8-9), the NIH test data relied upon
by Liotta is not conclusive because 100 micromolar is not the
highest reasonable test dosage which could have been employed.
To prove the point, Dionne refers to literature publications of
Dr. Schinazi where tests were purportedly conducted at higher
concentrations, e.g., 200 micromolar. We find this line of
reasoning unpersuasive since, as explained by Schinazi (LR 178-
184), activity may be related to toxicity at such high
concentrations. In other words, according to Schinazi, compounds
may be tested at concentrations exceeding 100 micromolar to
determine toxicity, but such high doses are not a reasonable or
practical basis for determining antiviral activity (LR 92-93,
107).
Dionne has not shown otherwise. In fact, Dionne has failed
to adduce any rebuttal evidence showing antiviral activity for a
sufficiently representative number of viruses, or showing that
the compounds in question would exhibit practical antiviral
activity against the viruses investigated at NIH if administered
at dosages above 100 micromolar without also producing excessive
toxicity with regard to a host cell or patient.
III. Alternative Finding
15
Page: Previous 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Next
Last modified: November 3, 2007