Appeal No. 2004-0670 Page 3
Application No. 09/276,741
[t]he instant claims differ from the prior art by reciting a dosage
exceeding 1300 mg. However, the determination of dosages is
dependent on a number of factors including age, sex, weight and/or
severity and type of illness. In the medical art, said determination is
routine and, thus, is well within the level of skill of the ordinary
artisan in the art. Thus, depending on the patient to be treated, it is
within the level of the skill of the ordinary artisan to administer
estramustine phosphate intravenously at a dose exceeding 1300
mg or 950 mg/m2.[2]
However, as set forth in In re Sebek, 465 F.2d 904, 907, 175 USPQ 93, 95
(CCPA 1972), “while it may ordinarily be the case that the determination of
optimum values for the parameters of a prior art process would be at least prima
facie obvious, that conclusion depends upon what the prior art discloses with
respect to those parameters.” As appellants point out (Brief, page 4), Bishop
teaches away from administering a dosage of estramustine phosphate (EM) that
exceeds 1300 mg as set forth in claims 1-8, 48 and 49, by teaching that such an
agent should be administered in an amount of only 0.1 to 1 µg/kg/day. According
to appellants (id.), “[e]ven for a 250 lb person, this recommended dosage is only
about 11.3 to 113 µg/day or 0.0113 to 0.113 mg/day….” Similarly, appellants
argue (Brief, page 5), Maier “discloses the intravenous administration of EM at a
dosage of 300, 600 or 900 mg….” As for Ramu and Rahman appellants point
out (Brief, pages 4 and 5), that neither reference suggests administering EM at a
dose that exceeds 1300 mg.
In response, the examiner asserts (Answer, bridging paragraph, pages 5-
6),
2 Appellants’ claim 2 is drawn to “[a] method of administering estramustine phosphate as an
intravenous dose, whereby the dosage of a single infusion exceeds 950 mg/m2. According to
appellants’ specification (page 7), mg/m2 refers to milligrams per square meter of body surface
area. According to page 8 of appellants’ specification, a dose of 900 mg/m2 is generally greater
than 1300 mg per dose. Accordingly, we limit our discussion to a dose in excess of 1300 mg.
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