Ex Parte DIMARCHI et al - Page 17






              Appeal No. 2004-0250                                                              Page 17                
              Application No. 09/226,412                                                                               

              column 2, line 65-column 3, line 38 (pulmonary means).  One purpose of the invention                     
              of Rubsamen is to control the symptoms of diabetes, i.e, control the blood glucose level                 
              of diabetic patients.  See, e.g., id., column 8, line 18-57.  Thus, Rubsamen describes                   
              the treatment of diabetic patients who are hypoglycemic and hyperglycemic in the                         
              manner required by claims 50 and 59.                                                                     
                     Dependent claims 51, 54-57, 60 and 63-66 are rejected under 35 U.S.C. §                           
              102(b) as anticipated by Rubsamen.                                                                       
                     Rubsamen is applied as above.  The details of these dependent claims are                          
              accounted for as follows:                                                                                
                                                       Table 2                                                         

               Claims 51 and 60 directed to                 Rubsamen, column 14, lines 40-45                           
               administering the monomeric insulin                                                                     
               analog as a pharmaceutical formulation                                                                  
               using a pharmaceutically acceptable                                                                     
               carrier.                                                                                                
               Claims 54-55, 63-64 directed to              Rubsamen, column 14, lines 40-60                           
               delivering the monomeric insulin analog                                                                 
               by way of an inhalation device such as a                                                                
               sprayer or dry powder inhaler in the lungs                                                              
               of the patient.                                                                                         
               Claims 56-57 and 65-66 directed to           Rubsamen, column 5, lines 55-68  In                        
               specific amounts of the monomeric            view of this disclosure it is reasonable to                
               insulin analog to be administered.           shift the burden to appellants to establish                
                                                            through objective evidence that the                        
                                                            amounts of the insulin analog delivered in                 
                                                            Rubsamen do not meet those required by                     
                                                            these claims.  In re Best, 562 F.2d 1252,                  
                                                            1255, 195 USPQ 430, 433 (CCPA 1977).                       






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