Ex Parte Muller et al - Page 4

                  Appeal 2007-2524                                                                                         
                  Application 10/194,834                                                                                   
                  4.  “[T]he compositions . . . contain one or more antibiotics in a                                       
                  concentration of from about 0.03 to about 30.0 percent by weight, based on                               
                  the total weight of the compositions (“wt. %”) (Cagle, at col. 4, ll. 7-11).                             
                  5.  Cagle’s disclosure that ciprofloxacin is a preferred antibiotic (Cagle, at                           
                  col. 2, ll. 63, at col. 3, l. 39) in its ophthalmic composition constitutes a                            
                  description of a composition comprising ciprofloxacin.                                                   
                  6.  The description of a composition comprising ciprofloxacin in Cagle, at                               
                  column 2, line 63 to column 3, line 39, does not describe the presence of a                              
                  preservative in describing a preferred composition comprising ciprofloxacin.                             
                  7.  Cagle does not state that a preservative is necessary to achieve the                                 
                  compositions’s purpose in sterilizing and treating post surgical infections.                             
                  8.  Example 1 shows a composition comprising 0.35 wt % ciprofloxacin and                                 
                  benzalkonium chloride (“BAC”) (Cagle, at col. 7, ll. 40-45).                                             
                  9.  Example 2 shows a composition comprising 0.03 wt % ciprofloxacin                                     
                  (Cagle, at col. 8, l. 18) which is within the range of “0.03 to about 30.0                               
                  percent by weight” described as being therapeutically effective (Cagle, at                               
                  col. 4, ll. 7-11).                                                                                       
                  10.  The composition of Example 2 does not contain BAC.                                                  
                  11.  The composition of Example 2 was used to determine the corneal                                      
                  penetration coefficient of the ciprofloxacin (Cagle, at col. 8, ll. 20-40).                              
                  12.  Example 3 shows formulations A, B, and C, each which comprise 0.35                                  
                  wt % ciprofloxacin and BAC (Cagle, at col. 8, ll. 41-65).                                                
                  13.  Claim 1 of Cagle is a topical ophthalmic solution comprising an                                     
                  antimicrobial effective amount of ciprofloxacin (Cagle, at col. 10, ll. 15-25).                          
                  14.  Claim 1 does not describe the presence of a preservative in the claimed                             
                  composition.                                                                                             

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