Ex parte Perc

July 14, 2011 – Blog Post

The claims in Perc (Appeal No. 2011-003119, Application No. 10/531,540, Decided on July 8, 2011) defined a pharmaceutical formulations comprising homogeneousmixtures of uncoated olanzapine or a pharmaceutically acceptable salt thereof with other pharmaceutically acceptable components. The issues on appeal were whether such claims were obvious: i) in view of EP 0830858 ("Morris") as evidenced by US 3,926,817 ("Nakajima"), and ii) in view of US 5,229,382 ("Chakrabarti") and Pharmaceutics: The Science of Dosage Form Design, 304-321, 2002 ("Rubinstein"). The Board of Patent Appeals and Interferences ("the Board") reversed the first rejection and affirmed the second rejection.

According to the Examiner, Morris disclosed the use of subcoated olanzapine in formulating pharmaceutical compositions, and disclosed that uncoated olanzapine is stable when stored in polyethylene bottles. Morris failed to disclose the use of the unpreferred uncoated olanzapine to make the formulations disclosed therein. However, the Examiner relied on the teaching of the storage stability of uncoated olanzapine and asserted that it would have been obvious to use the unpreferred uncoated olanzapine to make the Morris pharmaceutical compounds.

The Board sided with the Appellant’s on this issue finding that Morris taught away from the use of uncoated olanzapine, because Morris disclosed that formulations having uncoated olanzapine change color over time. Morris disclosed that patients most likely to be treated with olanzapine are patients suffering from hallucinations, where medications that change color over time would not be beneficial in treating the patient. Finding that “Morris strongly teaches away from the use of uncoated olanzapine” and citing In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994), the Board reversed this rejection.

On the other hand, the Board affirmed the obviousness rejection in view of Chakrabarti and Rubinstein. The Examiner asserted that Chakrabarti disclosed pharmaceutical compositions having uncoated olanzapine, and relied on the teachings of Rubinstein to assert that it would have been obvious to modify theChakrabarti formulations through routine experimentation to arrive at the claimed formulations. Appellant argued that the Chakrabarti methods of granulating the uncoated olanzapine would result in heterogeneous compositions, and therefore the prior art failed to disclose or suggest homogenousmixtures of the claimed components. The Board, however, rejected Appellant's arguments as "attorney argument" (citing In re Pearson, 494, F.2d 1399, 1405 (CCPA 1974) finding that there was no factual basis for this argument. The Board, citing KSR, considered that Rubinstein's teaching of combining the ingredients in a blender and blending the ingredients is sufficient to support the conclusion that the prior art disclosed homogenous formulations. The Board also rejected Appellant's assertion of unexpected results, arguing that Appellant did not provide a comparison between a claimed composition and a representative composition from Chakrabarti (citing In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991), and that the unexpected results presented by the Appellant were not commensurate-in-scope with the claims (citing In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005).