Appeal No. 2006-3234
Application No. 90/006,410
26. The ‘106 disclosure lists “inadequate or excessive moisture
content of the granulate” as a possible cause of capping. (‘106
at 2:2-7).
27. Otaya also recognizes a link between moisture content and
capping.
28. Otaya “found that capping depended on the amount of moisture
and could be almost completely eliminated.” (Otaya at 1).
29. Otaya discloses that “it is a well-known fact that when a
medicine is made into a tablet by a stamping machine, in nearly
all cases a binding agent is added to the formation” and that
“even if a binding agent is added, capping often occurs.”
(Otaya at 1).
30. Otaya describes an “experiment” where the drug sulfamin was
made into tablets. (Otaya at 1).
31. Otaya used sulfamin tablets having various moisture contents in
the range of .24% to 1.25%. (Otaya at 4, Table 2).
32. Otaya concluded that “[g]ranule moisture is an important cause
of capping[,]…the greater the stamping pressure, the stronger
the capping tendency;…[t]here is no correlation between
hardness and capping;..[and] the size of sulfamin crystal
particles had little effect on capping”. (Otaya at 4).
33. Otaya does not disclose a tablet containing metformin.
Evenstad
34. Evenstad teaches tablets formed by a wet granulation technique
using an aqueous solvent, hydroxypropyl cellulose for
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