EDWARDS et al. V. LEVEEN - Page 12






         Interference No. 104,290                                                            



         mass" to mean a preselected mass. There is no evidence that any                     

         area in the explanted livers was first targeted, the apparatus                      

         used, and the target area inspected to compare the actual abla                      

         tion accomplished to that ablation desired in the targeted area.                    

                    Next, there is no convincing evidence that the experi                    

         ments were successful. Discounting conclusory statements from                       

         Fox, LeVeen and Kilzer made years after the experiments were                        

         undertaken, no standards for success were ever established and                      

         no contemporaneous recognition of success can be found in the                       

         records. Indeed, a grant proposal indicates the results were                        

         preliminary, and testimony and the grant proposal indicates the                     

         experiments were merely exploratory in nature.                                      

                    Thirdly, the invention was not tested in its intended                    

         functional setting, so the inventors did not determine that it                      

         would work for its intended purpose. The interference subject                       

         matter was tested in an explanted liver in repose on an electrode                   

         plate. Credible testimony establishes that such experimental                        

         conditions do not simulate the impedance of the body of a                           

         patient, the movement of the organs in a patient under surgical                     

         conditions, or the heat-sink/cooling effect of blood flow of a                      

         living organism. Our findings of fact and conclusion of law                         

         follow.                                                                             

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