Appeal No. 2004-0394 Page 5
Application No. 09/915,467
report is based on data obtained prior to 1999, and that which is not is only relevant up
to the March 31, 2000 cut-off date. Thus, it follows from appellant’s assertion (Request,
page 3) that the FDA’s comments are based on an interpretation of the Roche data,
that this interpretation would be accurate only with regard to the data obtained prior to
1999. Any inference drawn from data covering the period from 1999 through the March
31, 2000 cut-off data would be based on data that is characterized by Roche as
unstable.
Accordingly, we find appellant’s characterization of the Roche data as “2001
data” to be factually unsupported on this record. Therefore, we are not persuaded by
appellant’s assertion that our earlier finding is “baseless, directly contradicted by the
subsequent 2001 data, and thus unsustainable as a matter of law.”
III. Appellant’s assertion regarding Elsayed is factually incorrect:
Appellant’s assertion (Request, page 4, fn. 1, alteration original) that “ELSAYED
does not ‘provide[ ] patients with a contraceptive device or formulation’ Cf. DECISION at
7,” is also factually incorrect. See Decision, page 4, emphasis added, “the last two
steps (step g and step h) of the Elsayed method require (step g) pharmacies to fill
prescriptions for non-pregnant patients, and (step h) provide patients who are capable
of becoming pregnant a contraceptive device or formulation. See e.g., Elsayed, claim 1
and claim 10.”
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