Ex Parte MCDONALD - Page 21





                Interference No. 104,544 Paper149                                                                                                 
                McDonald v. Miyazaki Page 21                                                                                                      
                        (b) Under this section, information is material to patentability when it is not                                           
                        cumulative to information already of record or being made of record in the                                                
                        application, and                                                                                                          
                        (1) It establishes, by itself or in combination with other information, a                                                 
                        prima facie case of unpatentability of a claim; or                                                                        
                        (2) It refutes, or is inconsistent with, a position the applicant takes in:                                               
                        (i) Opposing an argument of unpatentability relied on by the Office, or                                                   
                        (ii) Asserting an argument of patentability,                                                                              


                        In requiring both materiality and intent, United States Patent and Trademark                                              
                Office practice corresponds to the practice in Article III courts:                                                                
                        Inequitable conduct includes affirmative misrepresentation of a material                                                  
                        fact, failure to disclose material information, or submission of false                                                    
                        material information, coupled with an intent to deceive.                                                                  
                Board of Ed. v. Am. Bioscience, Inc., 333 F.3d 1330,1343, 67 USPQ2d 1252, 1261                                                    
                (Fed. Cir. 2003). The standard methodology for determining inequitable conduct                                                    
                involves three steps. First, find whether the conduct meets a threshold level of                                                  
                materiality. Second, find whether the conduct meets a threshold level of intent. Finally,                                         
                if the threshold levels have been found, weigh them to determine whether the conduct                                              
                is so culpable that the patent should be held unenforceable. Id., 333 F.3d at 1343,                                               
                67 USPQ2d at 1261-62.                                                                                                             
                        In proceedings before the United States Patent and Trademark Office, as in                                                
                Article III court proceedings, the facts of inequitable conduct must be established by                                            
                clear and convincing evidence for both applications and patents. See In re Harita,                                                
                847 F.2d 801, 808, 6 USPC12d 1930, 1935 (Fed. Cir. 1988) (ex parte application);                                                  







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