Appeal No. 2004-0670 Page 6
Application No. 09/276,741
infiltration or extravasation into tissue surrounding an injection or infusion site.
Vesicant compounds include … estramustine phosphate … [and] taxol.”
However, as appellants point out (Brief, page 4, emphasis removed), “the
purpose of Ramu is to treat or prevent extravasation injury caused by
intravenous administration of even conventional dosages of vesicant
compounds.” While Ramu teach photochemical methods to address this issue,
the examiner asserts (Answer, page 5), Rahman3 teach “encapsulation of a
pharmaceutical agent within a liposome minimizes some of its side effects or
drawbacks such as the ability to administer the compound as a bolus … as well
as reduction in irritation caused by said pharmaceutical agent.” Thus, according
to the examiner (id.), “the encapsulation of estramustine phosphate would have
been prima facie [sic] obvious to the ordinary artisan in the art.”
However, contrary to the examiner’s assertion, Rahman does not broadly
teach “encapsulation of a pharmaceutical agent within a liposome,” instead,
Rahman teach liposomal-encapsulated taxol. Furthermore, contrary to the
examiner’s assertion Rahman does not teach that liposomal-encapsulation of a
vesicant compound will result in a reduction of the irritation caused by the
vesicant compound. Instead, Rahman teach (column 1, lines 60-65), “[i]n clinical
trials, a consistent problem of anaphylactoid reaction, dyspnea, hypertension and
flushing have been encountered [with taxol treatment]. The cardiac toxicity of
taxol is treatment limiting and because of this the patient has to be hospitalized
3 Contrary to appellants’ assertion (Brief, page 10), Rahman is not limited to parenteral
administration of liposomal formulations. To the contrary, Rahman teach the liposomal
formulations are generally administered intravenously or intraperitoneally. Rahman, column 8,
lines 37-40.
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