Ex parte TROFAST et al. - Page 7




          Appeal No. 1999-0400                                                        
          Application No. 08/316,938                                                  

         II. The 35 U.S.C. § 103(a) rejection of claims 1, 7, 8 and 31/1              
         as being unpatentable over Edwards in view of Szczesny, Edmonds              
         and Bremer                                                                   
              Edwards discloses a chemical compound for the treatment of              
         various medical conditions such as asthma, hay fever and                     
         bronchitis.  The compound has a physical form (form X) which                 
         can be administered to a patient as a micronised powder by                   
         inhalation.  The mean mass aerodynamic diameter of the powder                
         particles “is conveniently less than 50 microns, preferably in               
         the range of from 1 to 50 microns, more preferably 1 to 10                   
         microns, especially 1 to 5 microns” (page 3, lines 45 through                
         47).  In order to improve its flow and handling                              
         characteristics, the powder is formed into soft pellets which                
         readily break down to particle size in an inhaler to permit                  
         good penetration into the patient’s lungs.  As described in the              
         reference,                                                                   
                   . . . the invention provides a process for                         
              obtaining form X in the form of soft pellets, which                     
              comprises extruding micronised form X through a sieve                   
              having apertures with a diameter in the range of from                   
              150 to 700 microns, rolling the extruded material,                      
              and then screening the rolled material.                                 
                   The micronised form X is preferably extruded                       
              through a sieve having apertures with a diameter in                     
              the range of from 175 to 600 microns.  The extrusion                    
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