Ex Parte MANDEVILLE et al - Page 3


                 Appeal No. 2003-0564                                                        Page 3                   
                 Application No. 08/964,498                                                                           

                        Treatments for hyperphosphatemia include “oral administration of                              
                 insoluble phosphate binders to reduce gastrointestinal absorption.”  Id.                             
                 Phosphate binders that have been used in such therapies include calcium salts,                       
                 aluminum salts, and ion exchange resins.  See id., pages 2-3.  All of these                          
                 agents, however, can cause serious side effects.  See id.                                            
                        The specification discloses a method of lowering the serum phosphate                          
                 level of a patient by administering a polymer having diallylamine repeat units.                      
                 These poly(diallylamine) polymers are disclosed to have “excellent phosphate-                        
                 binding activity.”  Page 4.                                                                          
                                                     Discussion                                                       
                        Claim 9, the broadest claim on appeal, is directed to a method for lowering                   
                 the serum phosphate level in a patient by administering a therapeutically                            
                 effective amount of a poly(diallylamine) that comprises repeat units having one of                   
                 two recited structures.  The structures comprise a heterocyclic, five- or six-                       
                 membered ring that includes a quaternary ammonium group.                                             
                        The examiner rejected the claimed method as obvious in view of Howes                          
                 and Holmes-Farley.  The examiner’s statement of the rejection reads as follows:                      
                        [Howes] teaches polymers comprising heterocyclic diallyl                                      
                        ammonium monomers (Abstract).  [Holmes-Farley] teaches                                        
                        phosphate binding polymers for treating hyper phosphatemia                                    
                        (Abstract).  Quaternary amines are specified (claim 31).                                      
                        It would have been obvious to one of ordinary skill to use the                                
                        polyallylamines of [Howes] to treat hyper phosphatemia in view of                             

                                                                                                                      
                 intended to imply an alternative basis for the rejection, we vacate any implied rejection based on   
                 references other than Howes and Holmes-Farley.                                                       





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