Ex Parte Nair et al - Page 18


               Appeal No. 2006-1245                                                                        Page 18                   
               Application No. 10/294,106                                                                                            

                       Patwardhan discloses the administration of a composition comprising an extract                                
               of W. somnifera for the treatment of rheumatoid arthritis and osteoarthritis.  Abstract.                              
               As discussed supra, arthritis is an inflammatory condition in which COX-2 is active.                                  
                       Patwardhan also teaches that the described therapeutic extract of W. somnifera                                
               contains withanolides.  Column 5, lines 13-25 (“Chemical constituents include . . .                                   
               steroidal glycosides (sitoindosides and withanolides).  Withaferin A is the most                                      
               important of the withanolides.  Sitoindosides and Withanolides are together mainly                                    
               responsible for the biological activity of Ashwagandha . . . .”).                                                     
                       Patwardhan therefore discloses the administration of a composition comprising                                 
               withanolides, including one of those purified by Appellants from leaves (Withaferin A;                                
               see Specification, page 8, lines 15-16), to a patient to treat a condition whereby COX-2                              
               is active.                                                                                                            
                       With respect to the requirement that the withanolide be “isolated,” we note that,                             
               for examination purposes, claims must be construed as broadly as reasonable, in a                                     
               manner consistent with the specification.  Sneed, 710 F.2d at 1548, 218 USPQ at 388.                                  
               At its broadest, the term “isolated” requires only that the withanolide be isolated from                              
               something.  Through the extraction process, the withanolides within Patwardhan’s                                      
               extract have necessarily been isolated from a number of the ingredients originally                                    
               present in the plant.  The withanolides within Partwardhan’s extract therefore meet the                               
               limitation that they be “isolated.”                                                                                   
                       Lastly, the therapeutic effect of the disclosed extract demonstrates that                                     
               Patwardhan’s composition contained an isolated withanolide in an amount effective to                                  
               selectively inhibit COX-2.  This is especially true in view of the disclosure in Appellants’                          





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