Ex Parte DIMARCHI et al - Page 3



              Appeal No. 2004-0250                                                               Page 3                
              Application No. 09/226,412                                                                               

                     Patent documents discussed by this merits panel are:                                              
              Rubsamen                          5,364,838            Nov. 15,1994                                      
              Baker et al. (Baker)              5,504,188            Apr.   2, 1996                                    
              Chance et al. (Chance)            5,514,646            May   7, 1996                                     
              Gonda et al. (Gonda)              5,743,250            April 28, 1998                                    
                     Claims 30 through 32, 34 through 46, 48 through 67 stand rejected under 35                        
              U.S.C. § 102(e) as anticipated by Jensen.  In reviewing the examiner’s rejection, we                     
              find ourselves in agreement with the examiner’s conclusion that Jensen is an                             
              anticipation under 35 U.S.C. § 102(e) and that the proffered declarations under 37 CFR                   
              § 1.131 are ineffective in removing Jensen as a basis for rejection.  However, we reach                  
              our conclusion based upon a significantly different basis than the examiner.  Thus, we                   
              denominate our affirmance of this rejection as a new ground of rejection under 37 CFR                    
              § 1.196(b).  In addition, we make additional rejections under 37 CFR § 1.196(b) on                       
              other prior art grounds.                                                                                 
                                                     Background                                                        
                     The claimed invention is directed to administering a monomeric insulin analog to                  
              a patient in need.  Claim 30 is specific to the modified human insulins to be                            
              administered and requires that the stated modified human insulins be “inhaled through                    
              the mouth of said patient” by “pulmonary means.” Claims 50 and 59 on the other hand                      
              do not require the specific monomeric insulin analogs of claim 30 and only require that                  
              the monomeric insulin analog be administered by “pulmonary means.”                                       
                     Insulin is used to treat patients suffering from diabetes mellitus.  Specification,               
              page 1.  A certain percentage of diabetics self-administer one or more doses of insulin                  
              per day by subcutaneous injection.  Id., page 2.  A non-injectable form of insulin is                    





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