Ex parte MATTSSON et al. - Page 9




                  Appeal No. 1997-2795                                                                                                                    
                  Application No. 08/438,933                                                                                                              


                  prior art as to render the instant products prima facie obvious to the worker of ordinary skill in the art                              

                  at the time the invention was made” (answer, page 7) and, therefore, “the burden is on the appellants to                                

                  show a novel or unobvious difference between the claimed products and the product of the prior art”                                     
                  (answer, page 8).   We disagree.4                                                                                                                   

                           While the heparin derivatives of the prior art do show a sulfur content, i.e., degree of sulfation,                            

                  equal to or higher than the starting heparin from which they were derived, they have molecular weights                                  

                  lower than that of the starting heparin.  In fact, both the anti-Xa activities and APTT/anti-Xa ratios of                               

                  the derivatives of Naggi ‘063, to the extent that they are disclosed, do not meet the limitations of the                                

                  heparin derivatives in the claimed invention.  Moreover, Naggi ‘063 explicitly states that it is the anti-                              

                  Xa/APTT ratio which allows evaluation of “the anticoagulant component of the potential antithrombotic                                   

                  activity of the depolymerized and supersulfated heparins of the present invention without associated                                    

                  hemorragic risks” (col. 9, lines 20-24).  Given the difference in anti-Xa/APTT (or APTT/anti-Xa) ratio                                  

                  between the heparin derivatives of Naggi ‘063 and the claimed derivatives in combination with the                                       


                           4As stated in In re Best, 562 F.2d 1252, 1255-56, 195 USPQ 430, 433-34  (CCPA 1977):                                           
                                    Where, as here, the claimed and prior art products are identical or substantially                                     
                                    identical, or are produced by identical or substantially identical processes, the                                     
                                    PTO can require an applicant to prove that the prior art products do not                                              
                                    necessarily or inherently possess the characteristics of his claimed product.  ...                                    
                                    Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima                                        
                                    facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of                                     
                                    proof is the same, and its fairness is evidenced by the PTO's inability to                                            
                                    manufacture products or to obtain and compare prior art products.                                                     

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