Appeal No. 2004-0494 Page 3
Application No. 09/215,831
system or composition is a surfactant system….” In this regard, appellants point
out (id.),
Lacy discloses a carrier system for a hydrophobic drug which
comprises a digestible oil and a surfactant comprising 1) a
hydrophilic surfactant that does not substantially inhibit the lipolysis
of the digestible oil, or 2) a hydrophilic surfactant which
substantially inhibits the in vivo lipolysis of the digestible oil and a
lipophilic surfactant capable of at least substantially reducing the
inhibitory effect of the hydrophilic surfactant.
Accordingly, appellants assert (Brief, page 4), Lacy teaches away from the
present invention at column 1, lines 21-23 by disclosing “the administration of a
drug in oil alone is not advantageous because of the poor miscibility of the oil
with the aqueous environment of the gastrointestinal tract.” According to
appellants (Brief, page 4), contrary to the disclosure of Lacy, their claimed
composition “specifically exclude[s] a surfactant.” In addition, appellants argue
(id.), to the extent that the examiner relies on example 6 of Lacy, “[w]hile this
example does purport to disclose a solution of fenofibrate, there are four other
components, none of which is a monoglyceride as is required by each [of
appellants’] claim[s].”
Appellants are correct in that Lacy discloses in the background of the
specification (column 1, lines 21-23), “the administration of drug in oil alone is not
advantageous because of the poor miscibility of the oil with the aqueous
environment of the gastrointestinal tract.” Upon review of Lacy, we find that Lacy
discloses (column 3, lines 39-45), the invention “in its broadest aspect provides a
carrier system for a hydrophobic drug which comprises: (a) a digestible oil, and
(b) a pharmaceutically acceptable surfactant for dispersing the oil in vivo upon
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