Interference 102,413 Page 19
Pitha v. Muller
2. Solubilizing lipophilic drugs into the
aqueous media to form a solution and form a
solubilized drug/cyclodextrin derivative complex;
or
the composition of matter made by the method which
contains an amorphous complex of cyclodextrin
derivatives and a drug.
[Emphasis added]
To establish a reduction to practice Pitha must show (1)
solubilization of lipophilic drug in an aqueous mixture of
intrinsically amorphous cyclodextrin derivatives or (2) a
composition of matter made by the method which contains an
amorphous complex of cyclodextrin derivatives and a drug. We
have not been directed to evidence on this record which
discloses that the term “derivatives” is accorded a definition
other than normally prescribed for the term. Thus, we
interpret the count as requiring more than one cyclodextrin
derivative.
Pitha relies on the research of Dr. Ciesielski,
Dr. Czajkowska and Dr. Szente to establish an actual
reduction to practice of an embodiment which falls within the
scope of the count.
Dr. Pitha testified (PR 1-147) about the activities
performed in his laboratory said to establish an actual
reduction to practice of an embodiment within the scope of the
count. To show the reduction to practice, Dr. Pitha discusses
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