Ex Parte LEE - Page 11


                 Appeal No.  2004-1369                                                        Page 11                  
                 Application No.  08/966,233                                                                           
                 most potent compounds . . ., analogous to the benefit provided by the showing of                      
                 an in vivo utility.”  Id.  On the facts of that case – successful in vitro testing                    
                 supplemented by similar in vitro and in vivo activities of structurally similar                       
                 compounds – the court held that in vitro activity was sufficient to meet the                          
                 requirements of § 101.  See id.                                                                       
                        The Federal Circuit confirmed in In re Brana, 51 F.3d 1560, 34 USPQ2d                          
                 1436 (Fed. Cir. 1995), that human testing is not necessary to establish utility for                   
                 a method of treatment.  The invention claimed in Brana was a group of                                 
                 compounds disclosed to have antitumor activity.  See id. at 1562, 34 USPQ2d at                        
                 1437-38.  The claimed compounds were disclosed to have higher antitumor                               
                 activity than related compounds known to have antitumor activity, and the                             
                 applicants provided declaratory evidence of in vivo activity against tumors in a                      
                 mouse model.  See id., 34 USPQ2d at 1438.  The court held that these data                             
                 were sufficient to satisfy § 101; usefulness in patent law does not require that the                  
                 invention be ready to be administered to humans.  See id. at 1567, 34 USPQ2d                          
                 at 1442.                                                                                              
                        Several lessons can be drawn from Brenner and its progeny.  First,                             
                 § 101’s requirement that an invention be “useful” is not to be given its broadest                     
                 reach, such that little or nothing of a chemical nature would be found to lack                        
                 utility.  See Brenner, 383 U.S. at 530, 148 USPQ at 694.  Thus, not every “use”                       
                 that can be asserted will be sufficient to satisfy § 101.  For example, the steroid                   
                 compound at issue in Brenner was useful as a possible object of scientific                            
                 inquiry, and the polypropylene claimed in Ziegler was useful for pressing into a                      







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