Ex Parte 5955106 et al - Page 14

                Appeal No.  2006-3234                                                                           
                Application No.  90/006,410                                                                     

                construe its claim 1 as requiring a particular release rate.  While the ‘106                    
                disclosure states that the tablets of the invention release metformin “over a                   
                period of .5-10 hours” a release limitation is not found in the pharmaceutical                  
                composition of claim 1.4 While we construe a claim in view of the                               
                specification, we will not add a limitation to a claim where that limitation                    
                appears only in the specification.   We also do not find that the specification                 
                gives a special definition of  the term “hydrocolloid forming retarding agent”                  
                that would result in the term requiring the claimed composition to have a                       
                particular release rate.                                                                        
                       As noted by the examiner, the Red List does not identify the residual                    
                moisture content of Mediabet. However, Schneider’s declaration indicates                        
                that the product known as Mediabet had a pre-tableting residual moisture                        
                content of  “no more than 2.0 weight % (measured as drying loss) [and that                      
                t]he residual moisture content also exceeded a lower threshold of 0.5%...”                      
                Appellant does not take issue with this portion of the Schneider declaration.                   
                       We find that the examiner has met her burden of showing a sufficient                     
                basis to support a determination that Mediabet would inherently have the                        
                residual moisture content required by claim 1.  Given this showing, it is                       
                Appellant’s burden to show that Mediabet does not inherently possess the                        
                claimed residual moisture content.                                                              
                       Appellant argues, but has not directed us to evidence sufficient to                      
                show, that the pre-tablet composition of Mediabet “could be altered by                          
                additional drying steps or by the use of additional excipients, such as a                       
                                                                                                               
                4  We note that the Schneider declaration contains a record of a test of                        
                Mediabet showing a required release of the active ingredient at a rate of “>                    
                70% in 30 min” and a finding of a “95.75%” release in 30 minutes.                               

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