Ex Parte Steiner et al - Page 12

                 Appeal 2007-0318                                                                                      
                 Application 09/766,362                                                                                
                 ADDITIONAL FINDINGS OF FACT RELATING TO CLAIM 7                                                       
                        23.  Steiner discloses or suggests all the limitations of claim 7,                             
                 including nasal administration of an imaging agent (FFs 4-9), but does not                            
                 expressly disclose any device for nasal administration.                                               
                        24.  Nasal administration of drugs, including dry powder forms and                             
                 appropriate devices for doing so, was known in the art.  (See, e.g., Illum, col.                      
                 1, l. 22 to col. 4, l. 2 (describing the prior art).)                                                 
                        25.  Appellants’ single, general disclosure in the Specification of                            
                 methods of nasal administration supports the finding that such methods were                           
                 well known in the art.  (See Spec. 13, Example 1 (“The dry powder                                     
                 formulation can be administered by the use of a nasal insufflator . . .                               
                 preferably . . . provided with means to ensure administration of a                                    
                 substantially fixed amount of the composition.”).)                                                    
                        26.  One skilled in the art would have known the necessity of                                  
                 “delivering a measured dose” of a drug nasally and would have known how                               
                 to do so.  (FFs 24-25.)                                                                               
                        27.  Thus, given Steiner’s express disclosure of administering an                              
                 imaging agent to the nasal mucosa, the skilled artisan would have known to                            
                 use an appropriate “delivery device for delivering a measured dose of the                             
                 drug to the nasal mucosa.”  (FFs 23-26.)                                                              
                 Discussion of the Patentability of Claim 7                                                            
                        Based on our findings and those of the Examiner, we conclude the                               
                 subject matter of claim 7, including the delivery device, would have been                             
                 obvious to the skilled artisan in view of Steiner’s teachings and the skill in                        
                 the art, absent evidence establishing the criticality of the claimed average                          
                 particle size range.  (FFs 4-9, 24-27.)                                                               

                                                          12                                                           

Page:  Previous  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  Next

Last modified: September 9, 2013