Ex Parte NIVEN et al - Page 2




               Appeal No. 1996-3791                                                                                                   
               Application 08/028,087                                                                                                 


               37 CFR § 1.142(b) as not readable on th elected invention.   The subject matter of the                                 
               claims on appeal is directed to a method for the systemic administration of pegylated                                  
               granulocyte colony stimulating factor (G-CSF).                                                                         
                       Representative claim 29 is reproduced below:                                                                   
               29.     A method for the systemic administration of pegylated G-CSF, comprising                                        
               depositing a therapeutically effective amount of said pegylated protein optionally in a                                
               pharmaceutically acceptable carrier in the lungs of a mammal in need thereof while the                                 
               mammal is inhaling.                                                                                                    
                       Prior art references relied upon by the examiner as evidence of obviousness are:                               
               Platz et al. (Platz)                            5,284,656                      Feb. 8. 1994                            
               Eur. Pat. App. (Ishikawa)               A1 401 384                             Dec. 12, 1990                           
               Debs et al. (Debs), “Lung-Specific Delivery of Cytokines Induces Sustained Pulmonary                                   
               and Systemic Immunomodulation in Rats,” Journal of Immunology, Vol. 140, No. 10,                                       
               pp. 3482-488 (May 15, 1988).                                                                                           
               Takada et al. (Takada), “Evidence for the Pulmonary Absorption of Fluorescent                                          
               Labelled Macromolecular Compounds,” J. Pharm. Dyn., Vol. 1, pp.  281-87 (1987).                                        

                       The appealed claims 29 through 33 and 46 through 55 stand rejected under                                       
               35 U.S.C. § 103.3  As evidence of obviousness, the examiner relies upon Ishikawa,                                      


               Platz and Takada.  We note that this is a new ground of rejection (Examiner’s Answer,                                  


                       3  The amendment filed May 22, 1995 (Paper No. 16), amending claims 29-31 and 46-52 and                        
               cancelling claims 34-37, 39-45 and 56-59, was authorized entry by the examiner in the advisory action                  
               mailed June 21, 1995 (Paper No. 19), who also indicated that the amendment overcame the final rejection                
               of claims 29-33 and 46-55 under 35 U.S.C. § 112, first paragraph (lack of enablement).                                 
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