Ex Parte DIMARCHI et al - Page 18






              Appeal No. 2004-0250                                                              Page 18                
              Application No. 09/226,412                                                                               

                    Independent claim 30 and dependent claims 41, 48, 52, 58, 61, and 67 are                           
              rejected under 35 U.S.C. § 103(a).  As evidence of obviousness we rely upon                              
              Rubsamen and Chance.                                                                                     
                    These claims differ from the method described in Rubsamen by requiring a                           
              specified monomeric insulin analog such as Lyspro.  Chance describes Lyspro and the                      
              advantages it possesses over native human insulin.  Id., Column 1, lines 14-20                           
              (“[Lyspro] is less prone to dimerization or self-association to higher molecular weight                  
              forms thereby possessing a comparatively more rapid onset of activity while retaining                    
              the biological activity of native human insulin.”).                                                      
                    It would have been obvious to one of ordinary skill in the art to use Lyspro as the                
              monomeric insulin analog in Rubsamen for the advantages described by Chance.  As                         
              to the requirement of claim 41 that at least about 10% of the monomeric insulin be                       
              delivered to the lung, we direct attention to column 9, lines 23-35 of Rubsamen.                         
                    Dependent claims 31, 32, 34-40, and 42-46 are rejected under 35 U.S.C. §                           
              103(a).  As evidence of obviousness, we rely upon Rubsamen and Chance.                                   
                    The references are combined for the reasons set forth above.  The limitations                      
              added by these dependent claims are accounted for as follows:                                            












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