Appeal No. 2006-0674 Page 3
Application No. 10/083,565
Thus, the claims require intravenous administration of docetaxel to a patient with
hepatocellular carcinoma, in an amount sufficient to treat the hepatocellular carcinoma.
Discussion
The examiner rejected claims 7-9, 12 and 16-22 under 35 U.S.C. § 103 as
unpatentable in view of Broder.1 Broder teaches that “[m]any valuable
pharmacologically active compounds cannot be effectively administered by the oral route
because of poor systemic absorption from the gastrointestinal tract . . . [t]hese
pharmaceutical agents are, therefore, generally administered via intravenous or
intramuscular routes, . . . entailing considerable discomfort . . . and even requiring
administration in a hospital setting . . . in the case of certain IV infusions.” Broder,
column 1, lines 29-39. According to Broder, “certain agents which [ ] inhibit P-
glycoprotein drug transport activity, particularly cyclosporins, can be used to increase
substantially the oral bioavailability of otherwise poorly available or non-available
pharmaceutical agents” (id., column 4, lines 13-17).
Broder specifically mentions paclitaxel and docetaxel2 among a number of
“antitumor agents which heretofore were administered only parenterally”3 that “can now
be administered . . . by the oral route with sufficient bioavailability to provide . . . blood
concentrations which will be particularly effective in the treatment of patients with primary
1 Broder et al., U.S. Patent 6,245,805, issued June 12, 2001
2 According to Broder, “[d]ocetaxel has become commercially available as TAXOTEREŽ in parenteral form
for the treatment of breast cancer.” Broder, column 10, lines 17-18.
3 Parenteral administration is defined as “[b]y some other means than through the gastrointestinal tract or
lungs; referring particularly to the introduction of substances into an organism; i.e., by intravenous,
subcutaneous, intramuscular, or intramedullary injection.” Illustrated Stedman’s Medical Dictionary, 24th
Edition, Waverly Press, Inc., Baltimore, MD (1982).
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: November 3, 2007