Appeal No. 2006-3234
Application No. 90/006,410
“auxiliary ingredient.” Appellant discloses and claims polyvinylpyrrolidone
as a hydrocolloid forming retarding agent within the scope of claim 1. Thus
polyvinylpyrrolidone, on its face, appears to meet the claim limitation of
“hydrocolloid forming retarding agent.”
Appellant argues that “various substances such as
polyvinylpyrrolidone and methylhydroxypropyl cellulose may or may not
act as hydrocolloid forming retarding agents, depending on factors such as
molecular weight and/or viscosity of the specific grade that is used.” (Brief
at 6). Appellant directs us to the following statement in the Handbook of
Pharmaceutical Excipients, Fourth Edition (2003), p 296:
High viscosity grades [of hydroxypropylmethylcellulose]
may be used to retard the release of drugs from a matrix at
levels of 10-30% w/w in tablets and capsules.
It is Appellant’s burden to show that the polyvinylpyrrolidone of
Mediabet is not a “hydrocolloid forming retarding agent” within the
meaning of claim 1. This statement, which is not directed to
polyvinylpyrrolidone, does not show that the polyvinylpyrrolidone of
Mediabet cannot act as a hydrocolloid retarding agent within the meaning of
claim 1. Furthermore, Appellant has not pointed out where, within claim 1,
there is a requirement for polyvinylpyrrolidone having a particular molecular
weight or viscosity.
Appellant argues that the Red List “does not teach that the
MEDIABET tablets were an extended release product” and that the product
specifications found in the Schneider declaration indicate that
“[u]nquestionably, this release profile [of Mediabet] is that of an immediate
release product.” (Brief at 6). Appellant has not explained why we should
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