Appeal No. 2006-3234
Application No. 90/006,410
construe its claim 1 as requiring a particular release rate. While the ‘106
disclosure states that the tablets of the invention release metformin “over a
period of .5-10 hours” a release limitation is not found in the pharmaceutical
composition of claim 1.4 While we construe a claim in view of the
specification, we will not add a limitation to a claim where that limitation
appears only in the specification. We also do not find that the specification
gives a special definition of the term “hydrocolloid forming retarding agent”
that would result in the term requiring the claimed composition to have a
particular release rate.
As noted by the examiner, the Red List does not identify the residual
moisture content of Mediabet. However, Schneider’s declaration indicates
that the product known as Mediabet had a pre-tableting residual moisture
content of “no more than 2.0 weight % (measured as drying loss) [and that
t]he residual moisture content also exceeded a lower threshold of 0.5%...”
Appellant does not take issue with this portion of the Schneider declaration.
We find that the examiner has met her burden of showing a sufficient
basis to support a determination that Mediabet would inherently have the
residual moisture content required by claim 1. Given this showing, it is
Appellant’s burden to show that Mediabet does not inherently possess the
claimed residual moisture content.
Appellant argues, but has not directed us to evidence sufficient to
show, that the pre-tablet composition of Mediabet “could be altered by
additional drying steps or by the use of additional excipients, such as a
4 We note that the Schneider declaration contains a record of a test of
Mediabet showing a required release of the active ingredient at a rate of “>
70% in 30 min” and a finding of a “95.75%” release in 30 minutes.
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