EDWARDS et al. V. LEVEEN - Page 9





           Interference No. 104,290                                                            



                      Secondly, LeVeen argues that Hansen's testimony is                       
           irrelevant as based on a faulty legal conclusion that for a                         
           reduction to practice of the subject matter of the count, a                         
           successful test simulating or using the device in a living                          
           subject must be shown. LeVeen's argument is based on the premise                    
           that the count does not require the deployment or use of the                        
           device in living tissue. However, the case cited by LeVeen                          
           does not support LeVeen's argument. LeVeen cites Koval v.                           

           Bodenschatz, 463 F.2d 442, 447, 174 USPQ 451, 455 (CCPA 1972).                      
           While the case states that requirements derived from the objec                      
           tives of one of the parties that are not reflected in limitations                   
           embodied in the count ordinarily cannot be imposed on an asserted                   
           actual reduction to practice, 9 Koval affirmatively requires a                      
           relationship between the test conditions and the intended                           
           functional setting of the invention. Id. (citing Knowles v.                         

           Tibbets, 347 F.2d 591, 594, 146 USPQ 59, 61 (1965); Volsinet v.                     




                 9 In this instance, it appears that use in the organs of a                    
           living subject is an objective of both parties. See, for exam                       
           ple, LX-1002 at 8, lines 19 and 20: "treatment region may be                        
           located anywhere in the body" or "will comprise a solid tumor                       
           within an organ of the body" and EX-5004, col. 4, line 43-44,                       
           "the delivery catheter is advanced percutaneously to an internal                    
           body organ or site."                                                                
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