Ex Parte Donoho et al - Page 12


                 Appeal No. 2003-1794                                                       Page 12                    
                 Application No. 09/804,969                                                                            

                 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).                         
                        By contrast, Brenner’s standard has been interpreted to mean that “vague,                      
                 general disclosures or arguments of ‘useful in research’ or ‘useful as building                       
                 blocks of value to the researcher’” would not satisfy § 101.  See Kirk, 376 F.2d at                   
                 945, 153 USPQ at 55 (interpreting Brenner).  Likewise, a disclosure of a “plastic-                    
                 like” polypropylene capable of being pressed into a flexible film was held to show                    
                 that the applicant was “at best . . . on the way to discovering a practical utility for               
                 polypropylene at the time of the filing,” but not yet there.  Ziegler, 992 F.2d at                    
                 1203, 26 USPQ2d at 1605.                                                                              









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