Ex Parte Lasic et al - Page 7


              Appeal No. 2006-2213                                                                Page 7                
              Application No. 09/771,151                                                                                

              precipitated compound, and selecting a liposome size that corresponds to liposomes                        
              having no precipitated compound.3                                                                         
                     Regarding the claimed step of preparing liposomes at selected sizes, page 12 of                    
              Abra (cited in the examiner’s rejection) states at lines 13-14, that “[t]he liposomes,                    
              following diafiltration and dialysis, were extruded through 0.2 μm and 0.1 μm                             
              polycarbonate filters to size the liposomes to between about 100-120 nm.”  (Emphasis                      
              added.)   In our view, this disclosure meets the limitation in claims 1 and 16 requiring                  
              the preparation of liposomes of selected sizes.                                                           
                     Regarding the claimed step of analyzing the liposomes for the presence or                          
              absence of precipitated compound, Abra performed a number of analyses on the                              
              liposomes described on page 12.  Specifically, Abra determined (page 12, lines 17-18)                     
              the concentration of cisplatin within the internal phase of the liposomes.  (“The final                   
              liposomes contained an internal phase of cisplatin encapsulated at a concentration of                     
              8.5 mg/ml in 0.9% sodium chloride . . . .”).  Abra also evaluated the stability of the                    
              liposomes (page 12, line 23, through page 14, line 8).  The stability analysis required                   
              “determining the percent of encapsulated platinum” (page 12, lines 25-26), as well as                     
              verifying that the encapsulated platinum was “in the form of cisplatin” (page 13, lines 32-               
              33).                                                                                                      


                                                                                                                        
              3 Regarding Appellants’ statement that “Abra et al. fail to teach each of steps (ii), (iii) and (iv) as set forth
              in independent claims 1 and 16” (Brief, page 8), we note that the second, third, and fourth steps of claim 1
              actually correspond, albeit not identically, to the third, fourth and fifth steps of claim 16.  Despite   
              Appellants’ numbering scheme, however, it is clear from their argument that Appellants assert that Abra   
              does not disclose the claimed steps of preparing liposomes at selected size intervals, analyzing the      
              liposomes for the presence or absence of precipitated compound, and based on the analyzing, selecting     
              a liposome size that corresponds to liposomes having no precipitated compound.                            






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