Appeal No. 2006-3234
Application No. 90/006,410
Appellant’s argument that Otaya is directed to a tablet that does not
contain metformin and one which does not contain a hydrocolloid forming
extended release agent is not persuasive. The rejection is not one of
anticipation. Otaya is relied upon to show that one skilled in the art of tablet
making would have known that moisture content is a variable that must be
controlled in order to avoid capping and not for the general teaching of
metformin tablets.
The Vilkov declarations
1. Unpredictability
We note Dr. Vilkov’s testimony regarding the unpredictability of the
art of pharmaceutical formulation where Dr. Vilkov states that:
Pharmaceutical formulation is a very unpredictable art. Every
active agent and excipient has unique tabletting properties.
Data pertaining to one active agent and type of excipient does
not necessarily apply to a different active agent and type of
excipient. Modifying one tablet parameter can furthermore
affect more than one tablet property in an unpredictable way.
As a result, one of ordinary skill in the art would not look to
sources examining optimum moisture content levels for a
different active agent in order to determine the appropriate
moisture content for an extended release metformin product.
Dr. Vilkov has not provided us with a specific discussion of why one
skilled in the art would not have expected metformin tablets to perform
similarly to Otaya’s sulfamin tablets when it comes to capping, i.e., Dr.
Vilkov has not explained why one skilled in the art having Otaya at hand
“[e]thyl cellulose is insoluble in water whatever the pH.” (Abdallah at 17).
Dr. Vilkov’s testimony that ethyl cellulose is insoluble and not a
hydrocolloid forming polymer is consistent with Abdallah on this point.
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