Ex Parte Mathur et al - Page 11


                 Appeal No. 2003-2017                                                        Page 11                    
                 Application No. 09/802,116                                                                             

                 the time of the filing of the German application; but in that application Ziegler had                  
                 not yet gotten there.”  Id., 26 USPQ2d at 1605.                                                        
                        On the other hand, the CCPA reversed a rejection for lack of utility in In re                   
                 Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980).  The applicant in Jolles                              
                 claimed pharmaceutical compositions that were disclosed to be useful in treating                       
                 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                        





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