Ex Parte DIMARCHI et al - Page 6



              Appeal No. 2004-0250                                                               Page 6                
              Application No. 09/226,412                                                                               

              appellants’ claims and Jensen’s claims.  Reply Brief, page 2.  Appellants explain that                   
              this Board requires a two-way test be applied to determine whether claims in a patent                    
              application and an issued patent are directed to the same patentable invention, citing                   
              Winter v. Fujita, 53 USPQ2d 1234, 1243 (Bd. Pat. App. & Int. 1999).  Appellants then                     
              explain why the two-way test does not apply under the present circumstances.                             
                     Appellants are correct that the so-called two-way test must be met before an                      
              interference can be declared.  Eli Lilly & Co. v. Board of Regents of the Univ. of Wash.,                
              334 F.3d 1264, 1270, 67 USPQ2d 1161, 1166 (Fed. Cir. 2003) (“[W]e hold that the                          
              Director’s interpretation of 37 CFR § 1.601(n) as establishing a two-way test for                        
              determining whether two parties are claiming the ‘same patentable invention’ is neither                  
              plainly erroneous nor inconsistent with the language of the regulation.”).5  We have                     
              considered appellants’ position set forth in the Reply Brief as to why the two-way test                  
              cannot be met under the present circumstances, i.e., the Jensen patent claims are                        
              patentably distinct from the claims pending in this application.  We disagree and find                   
              that the two-way test is met.                                                                            
                     The relevant Jensen patent claims are claims 1, 14, and 15, which read as                         
              follows:                                                                                                 
                     1.  A therapeutic powder formulation suitable for pulmonary administration,                       
              comprising particles which comprise (i) human insulin, any analogue or derivative                        
              thereof, or combinations of the foregoing; and (ii) an enhancer which enhances the                       
              absorption of insulin in the lower respiratory tract, wherein at least 50% by weight of                  
              said particles are crystalline and herein the molar ratio of insulin to enhancer is between              
              about 9:1 and 1:9.                                                                                       

                     5  The present real party in interest is Eli Lilly and Company.  Amended Brief,                   
              page 2.                                                                                                  





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