Ex Parte OSI PHARMACEUTICALS, INC. et al - Page 5

               Appeal 2007-4007                                                                             
               Application 90/006,954                                                                       
               serves to distinguish claim 3 from the daily therapy of Probiodrug was, in                   
               fact, an inherent benefit of that therapy.                                                   
                      We find the anticipation rejection over the Probiodrug publication to                 
               be supported by a preponderance of the evidence of record on appeal.                         

                            Anticipation by the Villhauer published application                             
                      Villhauer is also interested in regulating the inactivation of GLP-1 by               
               regulating dipeptidyl peptidase IV (which Villhauer labels DPP-IV) in                        
               mammalian systems to treat diabetes and related conditions.  Villhauer calls                 
               the DPP-IV effectors "inhibitors" since their effect is to inhibit DPP-IV                    
               (Villhauer 1).  Villhauer also contemplates daily doses, beginning with a                    
               small dose that is increased until an optimal dosing level for the patient is                
               determined (Villhauer 19-20).                                                                
                      OSI again stresses the difference in the effect disclosed in Villhauer                
               versus the effect now claimed.  OSI also again urges that Villhauer teaches                  
               an acute treatment.  We again find the reference is not so limited.  Villhauer               
               expressly describes a program of repeated doses of the inhibitor in a                        
               mammal.  Villhauer also describes therapeutic effectiveness in treating                      
               diabetic symptoms.                                                                           
                      Although the Villhauer publication describes a different biological                   
               mechanism for the benefits it describes, we cannot read the reference to                     
               exclude other biological effects, including those now claimed.  Again,                       
               Villhauer teaches inhibitors targeting the same enzyme (DP IV) in the same                   
               pathway (GLP-1 inactivation) in the same patients to relieve diabetes-related                
               symptoms.  In the absence of any evidence to the contrary, we find that the                  
               inhibitors must inherently have the same effect that is now claimed for them.                


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