Ex Parte Lind et al - Page 11


                 Appeal No.  2005-0792                                                        Page 11                  
                 Application No.  09/750,373                                                                           
                 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                      
                 flexible film, yet both lacked sufficient utility to satisfy § 101.  See Brenner, 383                 
                 U.S. at 529, 148 USPQ at 696; Ziegler, 992 F.2d at 1203, 26 USPQ2d at 1605.                           
                        Rather than setting a de minimis standard, § 101 requires a utility that is                    
                 “substantial”, i.e., one that provides a specific benefit in currently available form.                
                 Brenner, 383 U.S. at 534-35, 148 USPQ at 695.  This standard has been found                           
                 to be met by pharmaceutical compositions shown to be useful in mouse models                           
                 and in humans for treating acute myeloblastic leukemia (Jolles, 628 F.2d at                           
                 1327-28, 206 USPQ at 891); by evidence showing successful in vitro testing                            
                 supplemented by similar in vitro and in vivo activities of structurally similar                       
                 compounds (Cross, 753 F.2d at 1051, 224 USPQ at 748); and by evidence                                 
                 showing in vivo antitumor activity in mice, combined with a disclosure that the                       
                 claimed compounds had higher antitumor activity than a related compound                               
                 known to have antitumor activity (Brana, 51 F.3d at 1567, 34 USPQ2d at 1442).                         







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