Ex Parte Donoho et al - Page 11


                 Appeal No. 2003-1794                                                       Page 11                    
                 Application No. 09/804,969                                                                            

                 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                      







Page:  Previous  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  Next 

Last modified: November 3, 2007