Appeal No. 2004-0482 Page 3
Application No. 09/216,247
drug carrier system that necessitates the inclusion of a surfactant.” In this
regard, appellants point out (Brief, bridging paragraph, pages 5-6),
Lacy discloses a carrier system for a hydrophobic drug
including a digestible oil and a surfactant component. The
surfactant component includes 1) a hydrophilic surfactant
component that fails to substantially inhibit the lipolysis of the
digestible oil, or 2) a hydrophilic surfactant component that
substantially inhibits the in vivo lipolysis of the digestible oil and a
lipophilic surfactant component capable of at least substantially
reducing the inhibitory effect of the hydrophilic surfactant….
Accordingly, appellants assert (Brief, page 4), Lacy teaches away from the
claimed invention. According to appellants (Brief, page 6), contrary to the
disclosure of Lacy, their claimed composition “specifically excludes a surfactant.”
Appellants are correct (see e.g., Brief, page 6) 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 administration of the carrier system, said surfactant comprising a
hydrophilic surfactant component….” As we understand Lacy’s disclosure, Lacy
overcomes the disadvantages of using drug in oil alone by including a hydrophilic
surfactant to the drug in oil composition.
However, as Lacy points out (column 3, lines 50-52), the majority of
hydrophilic surfactants “will inhibit the lipolysis of the digestible oil component.”
Therefore, to overcome the inhibitory effect of the hydrophilic surfactant, Lacy’s
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