Appeal No. 2004-1982 Page 4
Application No. 09/878,034
shown in Figure 3 of that reference, appellants contend, “indicates that less than
80 % of the drug had been released after 30 minutes in a pH 7.5 solution.” Id.
In response, the examiner asserts
that the composition of Example 3 of the Canadian Patent provides
a release profile, which indicates that less than 80% of the drug is
released after 30 minutes in a pH 7.5 solution, the examiner points
out that Applicant is testing his dissolution rate at pH 7.2, thus the
slight difference in dissolution profiles between Applicant’s
invention and the invention disclosed by the prior art could be a
result of the pH difference. Furthermore, it is noted that the
examples in the prior art are the inventor’s best mode. It is not
necessary for the prior art to disclose Appellant’s claimed release
profile as best mode, but merely to suggest to one of ordinary skill
in the art that the amounts of water-insoluble polymer and enteric
polymer in the coating may be varied according to the desired rate
of release of the active agent. Thus the skilled artisan would have
determined the optimal concentration of the water-insoluble
polymer and enteric polymer in the coating by routine
experimentation, in order to achieve the desired dissolution profile
of the active agent in the composition.
Examiner’s Answer, page 6.
We find that Example 3 of the Morella reference does not have the
dissolution profile as required by the claimed invention. As noted by appellants,
the release profile as shown in Figure 3 of Morella demonstrates that less than
80% of the active agent had been released after 30 minutes in a pH 7.5 solution.
In addition, we do not agree with the examiner’s contention that the difference
may be discounted because the claims require a pH of 7.2, whereas the pH used
by Morella to generate the release profile as shown in Figure 3 was a pH of 7.5.
As can be seen from Figure 3 of Morella, as the pH is decreased from 7.5 to 1.2,
the amount of active agent is decreased, rather than increased. That
observation is also supported by the language in the claims, which state that “the
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