Ex Parte EKSTROM - Page 6

                Appeal 2007-1154                                                                             
                Application 09/367,950                                                                       
                      (a) a first active ingredient which is formoterol, a pharmaceutically                  
                acceptable salt or solvate thereof or a solvate of such a salt; and                          
                      (b) a second active ingredient which is budesonide.                                    

                Written descriptive support:                                                                 
                      As an initial matter, we note that Appellant’s Specification discloses                 
                the step of administering an effective amount of the composition set forth in                
                claim 13 to a patient in need thereof (see, e.g., Specification 3: 21-27), but               
                the Specification, including the originally filed claims, does not appear to                 
                contain a literal disclosure of a method wherein a patient is instructed to                  
                inhale an effective amount of a composition on demand.  “Although the                        
                exact terms need not be used in haec verba, . . . the [S]pecification must                   
                contain an equivalent description of the claimed subject matter” (Lockwood                   
                v. American Airlines Inc., 107 F.3d 1565, 1571-1572, 41 USPQ2d 1961,                         
                1966 (Fed. Cir. 1997)).                                                                      
                      The phrases “instructing a patient to inhale” and “instructing a patient               
                to inhale the composition on demand” were added to the claim in                              
                Appellant’s April 20, 2001 Response to the Examiner’s December 18, 2000                      
                Non-final Action (Response 1-3).  Accordingly, we remand the application                     
                to the Examiner to clarify where written descriptive support for the                         
                foregoing phrases is found in Appellant’s Specification.  In this regard, we                 
                encourage Appellant to be an active participant in this determination and                    
                clearly explain where written descriptive support for this added language is                 
                found in their Specification.                                                                




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