Ex Parte Steiner et al - Page 14

                Appeal 2007-0318                                                                                
                Application 09/766,362                                                                          
                             Appellant's argument that 'the delivery systems of                                 
                       Illum contain absorption enhancers to increase bioavailability                           
                       and requires the formation of a gel' is not persuasive since                             
                       the instant 'comprising' claim language permits the presence                             
                       of additional components or additional steps aside from those                            
                       recited.   . . .                                                                         
                             . . .  The prior art teaches the use of the same                                   
                       ingredients (i.e., diketopiperazines, antihistamines), used for                          
                       the same field of endeavor (i.e.,mucosal applications) to treat                          
                       the same problems (i.e., retention of drug in nasal cavity) as                           
                       that desired by Applicants.  Since the prior art recognizes and                          
                       explicitly teaches drug delivery systems based on the                                    
                       formation of diketopiperazine microparticles and teaches the                             
                       microparticles to be in a suitable size range (between 0.1 and                           
                       10 microns -Steiner & between 10 and 100 microns -Illum),                                
                       the instant invention when taken as a whole, is rendered                                 
                       prima facie obvious to one of ordinary skill in the art.                                 
                (Answer 10-14 (emphasis in original).)                                                          
                       We frame the § 103 issue with respect to claim 3 as follows:  Would it                   
                have been obvious to one of ordinary skill in the art to incorporate a                          
                vasoconstrictor, antiinflammatory, analgesic, or chlorpheniramine as the                        
                drug of claim 1 in view of Steiner’s and Illum’s teachings?                                     
                ADDITIONAL FINDINGS RELATING TO THE COMBINATION OF REFERENCES                                   
                       28.  Illum discloses a drug delivery system for nasal administration,                    
                including microsphere particles containing an active drug, including                            
                chlorpheniramine (col. 9, ll. 48-55), and having a “size between 10 and 100                     
                microns.”  (Illum, col. 6, ll. 13-15.)  “Preferably, the particles are                          
                administered in the form of a powder by spraying and have bioadhesive                           
                properties.”  (Col. 4, ll. 13-14.)                                                              




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