Appeal No. 2006-2471 Page 3
Application No. 09/824,364
The dosage form is required by the claim to reduce “interaction between the
statin and the aspirin.” According to the specification, the combined use of aspirin and a
statin “may require special care” because of physical and chemical incompatibility. Id.,
page 1, lines 21-25. Statins are alkali salts and aspirin is acid. Id., page 1, lines 26-29.
Mixing the two together “could result” in aspirin hydrolysis and statin degradation. Id.,
lines 28-34. In this context, we understand the term “interaction” to include contact
between the drugs, e.g., that could produce drug damage or destruction.
The specification does not provide a definition of what structures or other means
are required by the claim to reduce the interaction between the two drugs, but it
provides several examples of how this is achieved. These include, a bilayered tablet
where the drugs are segregated into different layers (id., page 3, lines 1-10), a cored
tablet where one drug is present in the core and the other is contained in an outer layer
(id., page 3, lines 14-21), and granular mixtures where at least one drug is granular and
separately coated, e.g., with a polymer (id., page 4, lines 3-24). In the latter
embodiment, the granules can be mixed together. Id., page 4, lines 20-page 5, line 3.
In all three cases, the “dosage form” lessens direct contact between the alkaline statin
and acidic aspirin as they exist together in the single formulation.
When at least one coated granule (e.g., enteric coated aspirin) is mixed with an
uncoated granule (e.g., statin), we also presume that the rate of dissolution of the
coated drug is slowed in comparison to the uncoated drug, reducing contact between
the two in as they are released. Thus, the interaction can be reduced in the formulation,
itself, but also as the drugs dissolve and become bioavailable to the patient. Although
claims must be read in view of the specification, we must be careful not to import
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