Appeal No. 2006-0674 Page 6
Application No. 10/083,565
together with an MDR inhibitor, results in a much higher level of the antitumor agent in
the liver than is possible with IV infusion:
The active ingredients will penetrate the gut wall as a result of the prior
and/or concomitant administration of the MDR inhibitors . . . and will be
taken up by the portal circulation rapidly, providing a higher local initial
concentration of the chemotherapeutic agents in the liver (a far higher local
concentration than is currently achieved with IV infusion therapy) than in
the general systemic circulation or in most other organs at seven days.
Furthermore, . . . the higher levels of paclitaxel in the liver after oral
administration may not be reflected in increased plasma levels because of
the high first pass effect of the liver . . . [I]n selectively producing high blood
concentrations of antitumor agents, [the method] is particularly valuable in
the treatment of liver cancers (e.g., hepatocellular carcinoma and liver
metastases), gastrointestinal cancers (e.g., colon, rectal) and lung cancers.
Id., column 15, line 52 to column 16, line 6.
Apart from the higher than previously achieved local concentration of the
active ingredients in the liver, the plasma and tissue distribution of the
active target agents administered orally with the [ ] enhancing agents . . .
[is] similar to that observed upon IV administration.
Id., column 16, lines 28-33.
In our view, a reasonable inference is that selective concentration of the
antitumor agent in the liver, a consequence of Broder’s particular method of
administration, is what makes these antitumor agents “valuable in the treatment of
liver cancers” (id., column 16, lines 3-4). That being the case, we agree with
appellants that “Broder’s passing comments . . . that taxanes have previously
been administered parenterally cannot sustain an argument that Broder somehow
discloses parenteral (intravenous) use of docetaxel specifically in the treatment of
hepatocellular cancer” (Reply Brief, page 4).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial
burden of presenting a prima facie case of obviousness. Only if that burden is
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