Ex Parte Nair et al - Page 14


               Appeal No. 2006-1245                                                                        Page 14                   
               Application No. 10/294,106                                                                                            

               roots of the plant exhibit antiinflammatory activity.”  Id., at page 534, right column.  “The                         
               plant also inhibited antiinflammatory and antitumor activities.”  Id., citations omitted.                             
                       Thus, Thakur discloses that the whole plant, leaves, or roots of W. somnifera                                 
               have been administered to treat pathogenic conditions in which COX-2 is active.                                       
               Because the whole plant, leaves and roots inherently contain the claimed withanolides,                                
               Thakur discloses that the claimed withanolides have been administered to treat                                        
               pathogenic conditions where COX-2 is active.  Regarding the requirement in claim 3 of                                 
               a pharmaceutically acceptable carrier, we note that any of the non-withanolide                                        
               ingredients present in Thakur’s leaf, root, or whole-plant preparations can properly be                               
               considered a carrier.                                                                                                 
                       Based on the evidence before us, Thakur also discloses that the claimed                                       
               withanolides were administered in amounts effective to selectively inhibit COX-2.                                     
               Specifically, Appellants’ specification discloses the percentages of the claimed                                      
               withanolides within dried leaves.  Specification, page 17, lines 21-22 (“Yields of the                                
               withanolides are expressed in percentage dry weight of the leaves.”).                                                 
                       Compounds “1” through “5” correspond to the five withanolides recited in claims                               
               1 and 3, and the first Markush group in claim 15.  Specification, page 8, lines 5-15.  The                            
               concentrations of the claimed withanolides, based on the dry weight of leaves are:                                    
                       0.0068% for compound 1 (Specification, page 19, lines 3-4),                                                   
                       0.0078% for compound 2 (page 18, lines 26-27),                                                                
                       0.0055% for compound 3 (page 19, line 1),                                                                     
                       0.0032% for compound 4 (recovered as a mixture with compound 12, page 19,                                     
               lines 4-5), and                                                                                                       





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