Ex Parte Crabtree et al - Page 4

                Appeal 2007-1040                                                                               
                Application 09/960,708                                                                         
                2.  FK506 and CsA are immunosuppressive agents (Jiang 67,                                      
                col. 1, ll. 1-5).                                                                              
                3.  The term “effective amount” means “the amount required to achieve the                      
                desired result . . . where such amounts may readily be determined                              
                empirically”1 (Specification 8: ¶ 24).                                                         
                4.  The active “agent may be administered to the host using any convenient                     
                means capable of producing the desired result” (Specification 8: ¶ 25).  We                    
                understand this to mean that the agent can be administered both topically                      
                and systemically.                                                                              
                5.  The term “inhibiting” means “prevented from happening, or stopped”                         
                (Specification 11: ¶ 34).                                                                      
                6.  The term “host” encompasses “rodentia (e.g., mice, guinea pigs, and rats)                  
                . . . ” (Specification 11: ¶ 35).                                                              
                7.  “[S]ystemic administration of immunosuppressants promotes                                  
                carcinogenesis in parallel with the suppression of T cell functions” (Jiang                    
                69, col. 2, ll. 49-51).                                                                        
                8.  “In contrast to the case of systemic administration, topical application of                
                CsA . . . markedly suppressed skin tumor promotion caused by TPA . . .”                        
                (Jiang 69, col. 2, ll. 12-20).                                                                 
                9.  Jiang teaches “the inhibition of tumor formation in mice comprising the                    
                [topical] administration of FK506” (Answer 3; Br. 7).                                          


                                                                                                              
                1 According to Appellants’ Specification “[t]hose of skill will readily                        
                appreciate that dose levels can vary as a function of the specific compound,                   
                the severity of the symptoms and the susceptibility of the subject to side                     
                effects.  Preferred dosages for a given compound are readily determinable by                   
                those of skill in the art by a variety of means.”  (Specification 10: ¶ 33).                   
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