Ex parte CALANCHI et al. - Page 7




          nor would have suggested, the claimed two membranes capable of              
          releasing a drug in the claimed rate.                                       
                           NEW REJECTION UNDER § 1.196(b)                             
               Under the provisions of 37 CFR § 1.196(b), the following               
          new ground of rejection is entered against claims 1, 3, 7 and               
          9 through 11.                                                               
               Claims 1, 3, 7 and 9 through 11 are rejected under 35                  
          U.S.C.  § 103 as unpatentable over the disclosure of the                    
          Eichel reference.                                                           
               The Eichel reference describes a “sustained-release                    
          pharmaceutical preparation comprising an admixture of uncoated              
          and/or single walled water soluble drug, such as aspirin, and               
          dual walled coated drug (emphasis supplied).”  See abstract.                
          The dual wall structure has an inner wall microencapsular                   
          control coating and an outer wall enteric coating.  Id.; see                
          also page 3, lines 15-18.  “The inner wall microencapsular                  
          control coating is preferably selected from the group                       
          consisting of ethyl cellulose, hydroxy propyl cellulose and                 
          carboxy methyl cellulose.”  See page 3, lines 27-28.  The                   
          preferred outer wall enteric coating is cellulose acetate                   
          phthalate which dissolves at pH 7.5 as found in the intestine.              
          See page 3, lines 31-34.  “Other enteric coatings may be used               
          as long as they do not readily dissolve or disperse in the                  

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