Ex Parte Stapleton et al - Page 8


                 Appeal No.  2005-1797                                                         Page 8                  
                 Application No.  09/954,975                                                                           
                 attempt to distinguish (Reply Brief, page 8), gallium “in and of itself” from gallium                 
                 containing compositions, appellants’ claim 11 is open to include gallium                              
                 containing compositions as taught by Collery.  Further, appellants fail to direct                     
                 our attention to any evidence on this record to suggest that the gallium                              
                 compositions within the scope of their claims exhibited any unexpected benefit                        
                 over that taught by the combination of prior art relied upon by the examiner.  In                     
                 this regard, while appellants remain hesitant to acknowledge it, Collery discloses                    
                 that the gallium containing compositions disclosed therein exhibit anti-viral                         
                 activity.                                                                                             
                        Further, while appellants make reference to what they characterize as a                        
                 “low EC50/IC50 ratio”, they make no attempt on this record to explain to what this                    
                 “ratio” refers.  Accordingly, we offer the following.  We understand IC50 to refer to                 
                 “the half maximal inhibitory concentration.”5  Stated differently IC50 represents the                 
                 concentration of a drug that is required for 50% inhibition of viral replication in                   
                 vitro.  According to the data provided in Table VII (column 16) of Collery, all but                   
                 one of the gallium compositions exhibited a higher IC50 than AZT.  As for EC50,                       
                 we understand this term to refer to “the concentration of a compound that is                          
                 required to obtain 50% of the maximum effect.”6  Stated differently, EC50                             
                 represents the plasma concentration required for obtaining 50% of the maximum                         
                 effect in vivo.  As seen in Collery’s Table VII, a higher plasma concentration is                     
                 required for the gallium compositions to obtain their maximum effect relative to                      

                                                                                                                       
                 5 See “IC50” at Wikipedia, http://en.wikipedia.org/wiki/IC50.                                         
                 6 Id. n. 5.                                                                                           






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