Appeal No. 1997-2167 Application 08/137,444 disclose how the claimed compounds may be administered, what constitutes effective quantities for administration and the form in which the compounds may be administered (page 8, lines 1 through page 9, line 28 of the specification). Possessed of this disclosure, we have no doubt but that the skilled routineer would be able to prepare and use the claimed compounds in the manner disclosed above. The examiner's criticism of the claims as set forth in the statement of his rationale for rejecting the claims appears to be an expression of his concern that the claimed compounds and method of using the same may not be efficacious or even work at all. While the examiner's concern is laudable, it is misplaced here. As the court observed in In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436, 1442 (Fed. Cir. 1995): The Commissioner, as did the Board, confuses the requirements under the law for obtaining a patent with the requirements for obtaining government approval to market a particular drug for human consumption. See Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir. 1994) Simply stated, approval of the Food and Drug Administration is not a prerequisite for finding a compound useful within the 17Page: Previous 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 NextLast modified: November 3, 2007