Ex Parte ZIMMERMANN et al - Page 8



              Appeal No. 2003-0919                                                                   Page 8                 
              Application No. 09/463,097                                                                                    
                     Respecting the rejection under 35 U.S.C. § 103(a), the examiner notes that                             
              Zimmermann's compounds can be used in the therapy of tumoral diseases.  Again, we                             
              shall assume arguendo, without deciding, that Zimmermann describes the                                        
              methanesulfonic acid addition salt of imatinib.  The examiner apparently would invoke a                       
              per se rule of obviousness, viz., that merely changing the form, purity, or another                           
              characteristic of an old product, the utility remaining the same as that for the old                          
              product, does not render the claimed product patentable.  See Ex parte Hartop, 139                            
              USPQ 525 (Bd. App. 1962).  The examiner argues that (1) the $-crystalline form of the                         
              methanesulfonic acid addition salt of imatinib is merely a different polymorphic form of                      
              Zimmermann's methanesulfonic acid addition salt of imatinib; (2) the $-crystalline form                       
              recited in applicants' claims and the compound described by Zimmermann both possess                           
              anti-tumoral activity; and (3) accordingly, the subject matter sought to be patented in the                   
              appealed claims would have been prima facie obvious in view of Zimmermann.  We                                
              disagree.                                                                                                     
                     First, as stated in In re Ochiai, 71 F.3d 1565, 1572, 37 USPQ2d 1127, 1133                             
              (Fed. Cir. 1995):                                                                                             
                     The use of per se rules, while undoubtedly less laborious than a searching                             
                     comparison of the claimed invention--including all its limitations--with the                           
                     teachings of the prior art, flouts section 103 and the fundamental case law                            
                     applying it. Per se rules that eliminate the need for fact-specific analysis of                        
                     claims and prior art may be administratively convenient for PTO                                        
                     examiners and the Board. Indeed, they have been sanctioned by the                                      
                     Board as well. But reliance on per se rules of obviousness is legally                                  
                     incorrect and must cease.                                                                              










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