Ex parte KOSLEY JR. et al. - Page 17




          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                 

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