Ex Parte DIMARCHI et al - Page 2



              Appeal No. 2004-0250                                                               Page 2                
              Application No. 09/226,412                                                                               

              Claims 30, 50, and 59 are representative of the subject matter on appeal and read as                     
              follows:                                                                                                 
                     30.  A method of administering a monomeric insulin analog comprising,                             
              administering an effective amount of the monomeric insulin analog to a patient in need                   
              thereof by pulmonary means, wherein said monomeric insulin analog:                                       
                     a)  is selected from the group consisting of modified human insulins wherein:                     
                           i) the amino acid residue at position B28 is substituted with Lys, Leu, Val,                
                           Asp, or Ala, and the amino acid residue at position B29 is Lys or Pro;                      
                           ii) the amino acid residues at positions B28, B29, and B30 are deleted; or                  
                           iii) the amino acid residue at position B27 is deleted; and                                 
                     b) is inhaled through the mouth of said patient.                                                  

                     50.   A method for treating diabetes comprising, administering an effective dose                  
              of monomeric insulin analog to a patient in need thereof by pulmonary means.                             

                     59.   A method for treating hyperglycemia comprising, administering an                            
              effective does of a monomeric insulin analog to a patient in need thereof by pulmonary                   
              means.                                                                                                   
                     The reference relied upon by the examiner is:                                                     
              Jensen et al. (Jensen)             5,898,028            Apr. 27, 19992                                   








                     2   Jensen was filed on March 20, 1998, and is stated to be related to Provisional                
              Application No. 60/041648 filed on March 27, 1997.  In addition, the face of the Jensen                  
              Patent indicates that a claim for priority under 35 U.S.C. § 119 is made on the basis of                 
              Denmark 0319/97 filed on March 20, 1997.                                                                 





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