Ex Parte Davidson et al - Page 4

                 Appeal 2007-0860                                                                                      
                 Application 10/148,535                                                                                
                 we considered the factors set forth in Graham v. John Deere Co., 383 U.S.                             
                 1, 17 (1996); (1) the scope and content of the prior art; (2) the differences                         
                 between the prior art and the claims at issue; (3) the level of ordinary skill in                     
                 the relevant art; and (4) objective evidence of nonobviousness, if present.                           
                        Appellants argue that Harris discloses nothing about the use of l-                             
                 threo-methylphenidate, and even with respect to the d-threo isomer, they                              
                 only teach treating ADHD and narcolepsy (Br.2 3).  Gross-Tsur, Appellants                             
                 assert, does not remedy the deficiencies of Harris, as Gross-Tsur is drawn to                         
                 the use of a racemic mixture of methylphenidate in treating children having                           
                 ADHD (id. at 5).                                                                                      
                        Gross-Tsur is drawn to the study of “the safety and efficacy of                                
                 methylphenidate in children with the dual diagnosis of epilepsy and attention                         
                 deficit hyperactivity disorder (ADHD).”  (Abstract).  The study consisted of                          
                 30 children with the dual diagnosis and lasted for eight weeks (Id at 671).  In                       
                 the initial eight weeks, the children received only an antiepileptic drug, and                        
                 in the last eight weeks, both the antiepileptic drug and the methylphenidate                          
                 (id.).  During the first eight weeks, 25 children were seizure free and 5 had a                       
                 maximum of two seizures a week (id. at 672).  After the addition of                                   
                 methylphenidate, the seizure free children remained seizure free, whereas of                          
                 the 5 children with active seizures, three had an increase in seizures, one had                       
                 no change in seizures, and one was seizure free (id.).  Gross-Tsur states that                        
                 “changes in seizure frequency were noted when methylphenidate was given                               
                 to the five children who were still having seizures.  This observation may                            
                 simply reflect a normal variation in seizure frequency, but is does raise                             
                                                                                                                      
                 2 All references to the Brief (Br.) are to the Substitute Appeal Brief dated                          
                 March 28, 2006.                                                                                       
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