Ex Parte Davidson et al - Page 9

                 Appeal 2007-0860                                                                                      
                 Application 10/148,535                                                                                
                 “[i]n children with symptom[s] of disruptive behavior disorder                                        
                 (ADHD/conduct disorder) and a mood disorder (principally bipolar                                      
                 disorder), is there a differential improvement of their hyperactive or                                
                 inattention symptoms that is meaningful diagnostically or clinically to                               
                 [methylphenidate] or lithium treatment?”  (Id. at 263).  Seven psychiatrically                        
                 hospitalized children made up the study population (id.), and patients were                           
                 given placebo, methylphenidate alone, lithium alone, and a combination of                             
                 methylphenidate and lithium (id. at 264).  Carlson reports that “[s]everal                            
                 children had problems with increasing irritability and depressive symptoms                            
                 during the stay, and reports of even worse behavior in the late afternoons                            
                 and evenings on [methylphenidate] alone,” concluding that                                             
                 “[methylphenidate] may have worsened certain affective symptoms                                       
                 (depression and irritability) in some children without significantly improving                        
                 target symptoms.”  (Id. at 268-269.)  The reference does note, however, that                          
                 in “the behavioral arena [i.e., ADHD], at least in this sample, lithium does                          
                 not block MPH effects, it may enhance them.”  (Id. at 269.)                                           
                        From our reading of the reference, at best, Carlson seems to suggest                           
                 that methylphenidate is effective in treating some components of ADHD in                              
                 patients that may have both ADHD and bipolar disorder.  That reading,                                 
                 however, is tempered by the statement that methylphenidate may have                                   
                 worsened certain affective symptoms (depression and irritability) in some                             
                 children without significantly improving the target symptoms of the ADHD.                             
                 Again, contrary to the findings of the Examiner, we can find no teaching in                           
                 Carlson that bipolar disorder may be treated with methylphenidate, or even a                          
                 combination of methylphenidate and lithium.  Thus, while there may be                                 
                 some association between bipolar disorder and ADHD, we cannot dismiss                                 

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