Appeal No. 2004-1982 Page 5
Application No. 09/878,034
active ingredient is at least 80% dissolved in 30 minutes at pH 7.2 phosphate
buffer when tested according to USP method II at 50 rpm and is at least 70%
dissolved in 60 minutes in pH 5.6 acetate buffer when tested according to USP
method II at 50 rpm.” Thus, the evidence of record suggests that if the pH of the
release profile of the particle of Example 3 of Morella were to be generated at a
pH of 7.2, as required by the claims, rather than a pH of 7.5 as shown in Figure 3
of Morella, one of ordinary skill in the art would expect the amount of drug
released to decrease, rather than increase.
Finally, the examiner asserts that “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. The examiner has not, however, pointed to any teaching or suggestion
in the Morella reference, nor provided any evidence or argument, to demonstrate
why the ordinary artisan would have been motivated to modify the particle having
the dissolution profile shown Figure 3 of Morella to obtain a particle having the
claimed dissolution profile. “[C]onclusory statements” as to teaching, suggestion
or motivation to arrive at the claimed invention “do not adequately address the
issue of obviousness.” In re Lee, 277 F.3d 1338, 1343-44, 61 USPQ2d 1430,
1433-34 (Fed. Cir. 2002). Thus, we find that the examiner has failed to meet the
burden of establishing a prima facie case that one of ordinary skill in the art
would have been motivated to modify the particle of Morella to arrive at the
claimed particle, and the rejection is reversed.
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