Appeal No. 2004-1731 Page 4
Application No. 09/524,113
that does not substantially inhibit lipolysis of an oil is an important property of
Lacy’s compositions … this is NOT a property of the presently claimed invention.”
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 composition
must also include a lipophilic co-surfactant. Lacy, column 3, lines 52-55.
Accordingly, as we understand Lacy’s disclosure, Lacy’s composition
includes four components,
1. a hydrophobic drug (such as fenofibrate2, see e.g., Lacy, column
12, line 23),
2. a hydrophilic surfactant (e.g., castor oil or hydrogenated caster oil
ethoxylates, see Lacy, column 7, line 10)
3. a digestible oil, and
4. a lipophilic surfactant.
In contrast, as discussed above, appellants’ claimed invention includes three
components,
1. a hydrophobic drug (a fibrate, such as fenofibrate3),
2 We find no argument on this record that Lacy does not teach fenofibrate. Accordingly, we find
that appellants’ have conceded these facts.
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