Ex parte CALANCHI et al. - Page 9




          Appeal No. 95-4962                                                          
          Application No. 07/972,660                                                  


          Tables I and II at pages 5 and 6.  These studies indicate that              
          the dissolution rate is dependent on the amount of polymers                 
          employed.  See also the paragraph bridging pages 4 and 5.                   
          Moreover, the desired sustained-release rate of a drug is                   
          dependent on the desired concentration of a drug in a blood                 
          stream, thus avoiding the risk of toxicity associated with a                
          higher concentration of the drug therein.  See page 3, lines                
          60-65 and page 4, lines 1-9.  Accordingly, we conclude that                 
          optimizing the amount of the polymers employed to obtain                    
          desired dissolution rates presumably as claimed would have                  
          been obvious to one of ordinary skill in the art.  See In re                
          Woodruff,                                                                   
          919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990);              
          In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980)              
          (optimizing a known result-effective variable is well within                
          the ambit of one of ordinary skill in the art).  One of                     
          ordinary skill in the art would have had a reasonable                       
          expectation of avoiding the risk of toxicity associated with a              
          high concentration of a drug in the blood stream via                        
          controlling the rate of its dissolution.                                    


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