Ex Parte Davidson et al - Page 5

                 Appeal 2007-0860                                                                                      
                 Application 10/148,535                                                                                
                 concerns regarding the presumably innocuous nature of methylphenidate in                              
                 children whose seizures are not well controlled.”  (Id. at 673-674.)  Gross-                          
                 Tsur concludes that “[c]aution is warranted for children still having seizures,                       
                 but the benefits of methylphenidate on the child’s behavior and academic                              
                 achievements should be weighed against the possible risks of additional                               
                 seizures.”  (Id. at 674.)                                                                             
                        Gross-Tsur, therefore, does not relate to the treatment of epilepsy                            
                 using methylphenidate, but to looking at the possible side effects of the drug                        
                 in epileptic children who are concurrently taking antiepileptic drugs.  Gross-                        
                 Tsur saw promising results with the use of methylphenidate in epileptics                              
                 with ADHD who had their seizures under control.  In those, who did not,                               
                 Gross-Tsur cautioned against, and repeatedly referenced the PDR’s caution                             
                 against, giving methylphenidate to patients who experience seizures                                   
                 apparently, because of the PDR’s warning that methylphenidate reduces the                             
                 seizure threshold.  While Gross-Tsur reports their results indicate that                              
                 methylphenidate does not increase the frequency of seizures in epileptics                             
                 with ADHD, there is nothing in Gross-Tsur that would render obvious the                               
                 treatment of a seizure disorder, such as epilepsy, using methylphenidate.  To                         
                 the contrary, Gross-Tsur specifically cautions against using methylphenidate                          
                 to treat ADHD in patients who also have a seizure disorder, stating that the                          
                 benefits as to behavior and academic achievements need to be weighed                                  
                 against the risks of additional seizures.                                                             
                        Thus, contrary to the findings of the Examiner, Gross-Tsur does not                            
                 disclose the treatment of a convulsant state such as epilepsy using the                               
                 racemic form of methylphenidate, and in fact cautions against its use in                              
                 children whose seizures who are not under control.  Combined with the                                 

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