Ex Parte Fleischner - Page 10

                  Appeal 2007-1615                                                                                         
                  Application 10/693,442                                                                                   

                         Appellant argues that Van Heerden “teaches a reasonable expectation                               
                  not of success, but of failure” (Appeal Br. 18), because Van Heerden’s data                              
                  shows that the active ingredient in Hoodia “suppresses appetite transiently,                             
                  then stimulates appetite” (id. at 15), which “causes marked weight gain”                                 
                  (id.).  Appellant cites Van Heerden’s Figures 5 and 6 in support of this                                 
                  contention.  Figures 5 and 6 represent data from Example 45, and they do                                 
                  show some inconsistencies - some animals given certain extracts lost body                                
                  mass, while some gained.  However, Van Heerden states that                                               
                         [a]nimals in this study received a restricted diet i.e. animals                                   
                         only received food between 12:00 and 3:00 pm daily.  This is                                      
                         different from all other biological assays conducted thus far,                                    
                         whereby food was available to the rats a[d] lib.  Animals were                                    
                         acclimati[z]ed over a seven day period (days -7 to -1), dosing                                    
                         took place from day 0 to day 6 at 9:00 am by oral gavage . . .                                    
                         The results generated during the study showed that the                                            
                         acclimatization period was too short.  Rats feed mainly during                                    
                         the night and the sudden change to a restricted access to feed                                    
                         for three hours during day-time, resulted in low daily feed                                       
                         intakes.  The daily intake of feed was still increasing in most                                   
                         groups at the end of the acclimatization period when dosing                                       
                         with the test items started.  As a result of this, the effect of the                              
                         test materials did not significantly affect the food intake of the                                
                         rats during the period of dosing.                                                                 
                  Van Heerden, col. 63, l. 53 to col. 64, l. 57.  In other words, Van Heerden                              
                  acknowledges that this particular experiment was flawed.  Therefore, we                                  
                  find that the data shown in Figures 5 and 6 do not support Appellant’s                                   
                  contention that “hoodia extracts cause body mass to increase, not decrease”                              
                  (Decl. I, ¶ 17).  Indeed, as discussed above, Van Heerden’s Example 44                                   
                  shows just the opposite.                                                                                 

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