Ex Parte TICE et al - Page 2




                Appeal No. 1998-0143                                                                                                            
                Application No. 08/268,177                                                                                                      


                Claims 11 and 12 are illustrative:                                                                                              
                                 11.  A method for eliciting neural fiber growth within the central                                             
                         nervous system which comprises:                                                                                        
                                 gaining access to the central nervous system of a patient;                                                     
                                 providing a microsphere comprising an effective neural fiber growth                                            
                         amount of neuro-active agent encapsulated within a polymer sufficient to                                               
                         elicit neural fiber growth, said polymer (1) being permeable to the neuro-                                             
                         active agent, (2) being biocompatible with the tissues of the central                                                  
                         nervous system, (3) being biodegradable within the tissues of the central                                              
                         nervous system without producing toxic byproducts of degradation, and                                                  
                         (4) having kinetic characteristics that may be manipulated to allow for the                                            
                         permeation of the neuro-active agent through the polymer at a controlled                                               
                         rate and a predetermined period of time; and                                                                           
                                 implanting said microsphere into the central nervous system of the                                             
                         patient.                                                                                                               
                                 12.  A method for delivering a pharmaceutically-active agent                                                   
                         directly into astrocyte cells of the nervous system which comprises                                                    
                                 (A) gaining access to the central nervous system of a patient;                                                 
                                 (B) implanting microspheres of an encapsulated pharmaceutically-                                               
                         active agent in a therapeutically effective amount within the presence of                                              
                         astrocyte cells within the central nervous system of a patient, wherein the                                            
                         microspheres have a diameter of less than about 45 :m and comprise a                                                   
                         polymer, said polymer (1) being permeable to the pharmaceutically-active                                               
                         agent, (2) being biocompatible with the tissues of the central nervous                                                 
                         system, and (3) having kinetic characteristics that may be manipulated to                                              
                         allow for the permeation of the pharmaceutically-active agent through the                                              
                         polymer at a controlled rate and a predetermined period of time.                                                       
                                                                  ISSUES                                                                        
                         Claims 11-15 stand rejected under 35 U.S.C. § 112, sixth paragraph, as failing to                                      
                adequately express a means or step for performing a specified function without recital                                          
                of structure, material, or acts in support thereof.  Claims 11-15 stand rejected under the                                      



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