Ex parte ARUFFO et al. - Page 12

                Appeal No. 94-1696                                                                                                            
                Application 07/811,129                                                                                                        

                         In the case before us, the specification provides only two                                                           
                working examples of fusion proteins which are capable of binding                                                              
                to CD11a/CD18; i.e., fusion proteins comprising ICAM-1 or ICAM-2.                                                             
                The specification fails to provide any guidance as to (i) the                                                                 
                construction of fusion proteins comprising other, structurally                                                                
                different, polypeptides, such as those indicated by Makgoba,                                                                  
                supra, which have the claimed binding specificity, or (ii) how to                                                             
                identify and isolate other such polypeptides.  Moreover, the                                                                  
                structural features of molecules having the claimed binding                                                                   
                characteristics are unpredictable.  That is, it is not possible                                                               
                to predict the structure of an LFA-1 ligand from the disclosed                                                                
                1 and ICAM-2 sequences.   Accordingly, in view of the breadth of5                                                                                      
                the claim language, the limited number of working examples, the                                                               
                unpredictable nature as to the types of ligands capable of                                                                    
                binding to the LFA-1 receptor, we hold that one skilled in the                                                                

                         5We note that the specification discloses that “the two                                                              
                most N-terminal domains of ICAM-1 and ICAM-2 which contribute to                                                              
                their interactions with LFA-1" only have 34 % identity on the                                                                 
                amino acid level.  Specification, p. 12, lines 26-27.  Moreover,                                                              
                ICAM-1 has three additional “immunoglobulin-like” domains which                                                               
                appear to play a role in the avidity for LFA-1.  Specification,                                                               
                sentence bridging pp. 12-13.                                                                                                  

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