Appeal No. 2006-3234
Application No. 90/006,410
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.
(Vilkov declaration at ¶ 9).
c) Abdallah discloses that the wet granulation
technique was successful with the following water
insoluble polymers [including] ethyl cellulose. These
polymers, as described in Abdallah, are framework-
forming agents used in an organic solvent-based wet
granulation process. These polymers do not form
hydrocolloids.
(Vilkov declaration at ¶ 4).
40. In the second Vilkov declaration, Dr. Vilkov discusses testing
where he “reproduced Example 1 of the ‘106 patent.” (Second
Vilkov declaration at ¶ 1).
41. The tested tablets were said to have been formulated using
metformin, hydroxypropyl methylcellulose, povidone, purified
water and magnesium stearate and then compressed using
various levels of compression force. (Second Vilkov
declaration at ¶¶ 2-4).
42. The “results and observations” section of the testing showed
“capping” at all levels of compression force for tablets having a
residual moisture content of .49%, but “no capping” at all levels
of compression force for tablets having residual moisture
contents of 1%, 2%, and 2.25% . (Second Vilkov declaration at
¶ 4).
9
Page: Previous 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Next
Last modified: September 9, 2013