Appeal No. 2006-0674 Page 2
Application No. 10/083,565
Background
“Hepatocellular carcinoma (HCC) is one of the most common cancers in
Southeast Asia and African countries . . . [and] [t]he survival rate of HCC patients is very
low.” Specification, page 1. Paclitaxel, an antimitotic drug isolated from the bark of Yew
trees, “inhibits tumour cell division by its action on microtubule assembly” and is “cell
cycle dependent, with cell cycle arrest occurring mainly at the G2/M phase” (id.).
“Recent studies have shown that paclitaxel is effective against various malignant tumour
cells such as brain tumour, gastric and prostate cancer, breast cancer, melanoma and
ovarian cancer” (id.), but “paclitaxel is not effective against hepatocellular carcinoma”
(id.).
Docetaxel is a semisynthetic taxoid structurally similar to paclitaxel. However,
according to appellants, “docetaxel can achieve non cell cycle dependent cytotoxicity in
HCC cells[,] . . . “indicat[ing] that the cytotoxic effect of docetaxel on HCC cells is
achieved by a different mechanism from that of paclitaxel” (id.). “Further, the in vitro
activity of docetaxel against HCC cells is significantly higher than that of paclitaxel at
concentrations of up to 1μM . . . suggest[ing] that docetaxel, unlike paclitaxel, will be of
practical use in the clinical treatment of hepatocellular carcinoma” (id.).
The Claims
Claims 7-9, 12 and 16-22 are on appeal. Claim 7, the only independent claim on
appeal, is representative:
7. A method of treating hepatocellular carcinoma, said method comprising
administering to a patient docetaxel in an amount sufficient to treat said hepatocellular
carcinoma, wherein said administering is intravenous.
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