Appeal No. 2004-0670 Page 7
Application No. 09/276,741
for continuous infusion of the drug.” Rahman teach (column 2, lines 4-9),
“[a]ttempts to prevent taxol cardiotoxicity and anaphylactoid reaction have
included reliance on pretreatment of patients with antihistamine and
corticosteroids, and by prolonging the infusion time from six to twenty four hours.”
Accordingly, the Rahman invention provides for a taxol delivery system which is
characterized by, inter alia, “avoidance of anaphylactoid reactions and
cardiotoxicity, … [and the] ability to administer taxol as a bolus or short infusion
rather than extended (24-hour) infusion of free taxol.” See id., at lines 60-68.
The examiner, however, failed to establish a nexus between estramustine
phosphate administration, and the anaphylactoid reactions and cardiotoxicity
attributed to taxol administration. The same is true of the other advantages
attributed to Rahman’s liposomal-encapsulated taxol, such as the avoidance of
solubility problems of taxol, improved taxol stability, increased therapeutic
efficacy of taxol, and modulation of multidrug resistance in cancer cells. See
Rahman, column 2, lines 60-68.
While the examiner asserts (Answer, page 5), Rahman teach “reduction in
irritation caused by said pharmaceutical agent,” at best, we find4 the only
suggestion in Rahman of irritation caused by taxol administration is that “[n]o
further injections could be given in mice which received free taxol because of the
sclerosis of the vein.” Rahman, column 5, lines 25-27. Rahman, however, is
silent as to the effect of liposomal-encapsulation on the irritation caused by taxol
administration. Rather than acknowledging any effect on taxol induced irritation,
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