Ex Parte Donoho et al - Page 10


                 Appeal No. 2003-1794                                                       Page 10                    
                 Application No. 09/804,969                                                                            

                 acute myeloblastic leukemia.  See id. at 1323, 206 USPQ at 886.  The active                           
                 ingredients in the compositions were closely related to daunorubicin and                              
                 doxorubicin, both of which were “well recognized in the art as valuable for use in                    
                 cancer chemotherapy.”  Id., 206 USPQ at 887.  The applicant also submitted                            
                 declaratory evidence showing that eight of the claimed compositions were                              
                 effective in treating tumors in a mouse model, and one was effective in treating                      
                 humans.  See id. at 1323-24, 206 USPQ at 887-88.  The court noted that the                            
                 data derived from the mouse model were “relevant to the treatment of humans                           
                 and [were] not to be disregarded,” id. at 1327, 206 USPQ at 890, and held that                        
                 the evidence was sufficient to support the asserted therapeutic utility.  See id. at                  
                 1327-28, 206 USPQ at 891.                                                                             
                        The Federal Circuit held in Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739                       
                 (Fed. Cir. 1985), that in vivo testing (as in Jolles) was not necessarily required to                 
                 show utility in the pharmaceutical context.  The Cross court stated that “[it] is                     
                 axiomatic that an invention cannot be considered ‘useful,’ in the sense that a                        
                 patent can be granted on it, unless substantial or practical utility for the invention                
                 has been discovered and disclosed where such utility would not be obvious.”  Id.                      
                 at 1044, 224 USPQ at 742 (citing Brenner v. Manson).  The court “perceive[d] no                       
                 insurmountable difficulty, under appropriate circumstances, in finding that the first                 
                 link in the screening chain, in vitro testing, may establish a practical utility for the              
                 compound in question.”  Id. at 1051, 224 USPQ at 748.  Successful in vitro                            
                 testing could provide an immediate benefit to the public, by “marshal[ling]                           
                 resources and direct[ing] the expenditure of effort to further in vivo testing of the                 





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