Ex Parte Basu et al - Page 3




              Appeal No. 2005-1152                                                                                       
              Application No. 10/202,616                                                                                 
              Rockwell Int’l Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522 (Fed. Cir. 1998).  In                      
              addition, “An inherent structure, composition or function is not necessarily known. . . .                  
              Insufficient prior understanding of the inherent properties of a known composition does                    
              not defeat a finding of anticipation.”  Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342,                     
              1349, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).                                                               
                     Prior to discussion of the prior art, we must interpret claim 1 before us.    Claim 1               
              recites a method for delivery via the pulmonary system comprising:  administering to the                   
              respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective                 
              amount of particles comprising: a bioactive agent in association with a charged lipid                      
              wherein the charged lipid has an overall net positive charge, the agent has an overall                     
              net negative charge upon association, the agent is not a nucleic acid and wherein                          
              release of the agent is sustained.  The specification, page 8, lines 19-23, states that the                
              “particles suitable for pulmonary delivery can comprise a therapeutic, prophylactic or                     
              diagnostic agent which possesses an overall net negative charge in association with a                      
              lipid which possesses an overall net positive charge” (emphasis added).   Thus, we                         
              interpret the phrase “the agent has an overall net negative charge                                         


              upon association” in claim 1 to mean that the bioactive agent has a negative charge.1                      


                     1   Note that the phrase “upon association” when read in context, that is with the                  
              meaning set forth in the specification, does not mean when the bioactive agent is in                       
              association with the charged lipid that the complex has an overall negative charge or                      
              that the bioactive agent retains a negative charge.                                                        
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