Appeal 2007-2212 Application 10/667,472 Appellants further argue that if a prima facie case of obviousness has been established, it has been rebutted with evidence of unexpected results. (Br. 4.) In particular, Appellants argue that Example 1 of the specification describes the preparation of a nanoparticulate beclomethasone composition . . . and compares it to a conventional beclomethasone composition. The specification states that “only about 7% of the [beclomethasone] presented as a suspension or raw drug substance reaches the impactor.” On the other hand, "the use of nanoparticles led to a significantly higher fraction reaching the impactor." In addition, a greater fraction of beclomethasone remained in the nebulizer when raw drug substance rather than the nanoparticulate form was used. Thus, the experimental results demonstrate that the nanoparticulate form of beclomethasone results in less waste and more effective delivery. (Id. at 9.) We are not persuaded by Appellants’ presentation of alleged unexpected results. Liversidge discloses that "extremely small effective average particle size can be prepared by wet milling in the presence of grinding media in conjunction with a surface modifier, and that such particles are stable and do not appreciably flocculate or agglomerate due to interparticle attractive forces". (Liversidge, col. 3, ll. 15-31). These particles “can be formulated into pharmaceutical compositions exhibiting unexpectedly high bioavailability.” (Liversidge, col. 3, ll. 15-31). Liversidge further teaches surface modified nanoparticles of corticosteroids. (Liversidge, col. 11, l. 40 to col. 12, l. 25.) We do not find that Appellants have compared the nanoparticles of the claimed invention with the closest prior art, Steroid A of Liversidge. When relying on comparative testing, the applicant is under a duty to compare his claimed invention with the closest prior art (i.e., steroid A of 7Page: Previous 1 2 3 4 5 6 7 8 9 Next
Last modified: September 9, 2013