Ex Parte BONNEFOY - Page 3



             Appeal No. 2000-1783                                                               Page 3                
             Application No. 08/817,719                                                                               
             mediation of cell adhesion, regulation of IgE and histamine release, rescue of B cells                   
             from apoptosis and regulation of myeloid cell growth.@  Specification, page 1.  A[Its]                   
             functional activities are mediated through the binding to specific ligands of cell-                      
             associated CD23, or sCD23 [(soluble CD23)], the latter acting in a cytokine-like                         
             manner.@  Id.  Ligands of CD23 include CD21 (CD23-CD21 interactions are believed to                      
             play a role in IgE production), and the β-integrins (cell adhesion molecules) CD11b and                  
             CD11c.  Id., page 2.  According to appellant, CD23 binding agents that block the                         
             interaction between CD23 and its ligands Awork in vivo in treatment or prophylaxis of . . .              
             autoimmune diseases.@  Id., page 4.                                                                      
                                                   DISCUSSION                                                         
             Enablement                                                                                               
                    In its broadest aspect, the present invention is directed to treating autoimmune                  
             disorders by administering an agent that binds CD23 and blocks its interaction with a                    
             ligand it normally binds in vivo (e.g., claim 14).                                                       
                    The examiner notes two principal concerns in concluding that A[t]he specification                 
             does not enable any person skilled in the art . . . to make and use the invention                        
             commensurate in scope with [the] claims.@  Answer, page 4.  First, the examiner argues                   
             that A[t]he specification discloses the treatment of rheumatoid arthritis in mice but does               
             not disclose the treatment of any other autoimmune disease@ (Id.), thus A[a]ppellant has                 
             not established in vivo therapeutic efficacy . . . [for] the numerous autoimmune diseases                
             encompassed by the claims@ (Id., page 5), even though A[t]he therapy of autoimmune                       
             diseases . . . is highly experimental and unpredictable@ (Id., page 4).  Second, the                     
             examiner argues that Athe claims encompass an enormous number of potential CD23                          
             binding agents,@ but A[t]he specification does not disclose the administration of a binding              



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