Ex Parte Lipps et al - Page 3


              Appeal No. 2006-2644                                                                Page 3                
              Application No. 10/047,945                                                                                

                     the mixture of saliva and LT-10, in comparison to the mixture of saliva and                        
                     water.  This shows that the binding of LT-10 to IgE in saliva in mouth.                            
              Page 8, lines 11-23.  “LT-10 treatment lowers the IgE level.”  Page 9, line 11.                           
                     The specification also describes an experiment in which co-inventor Binie Lipps                    
              self-administered LT-10 (2 mg per day) alone or in combination with Glucotrol® (a                         
              diabetes treatment) and monitored levels of various proteins.  See page 13.  IgE levels                   
              are shown in Table 4 (page 15).2                                                                          
                                                      Discussion                                                        
              1.  Claim construction                                                                                    
                     Claims 9-18 are on appeal.  Claims 1-8 are also pending but have been                              
              withdrawn from consideration by the examiner.  The claims have not been argued                            
              separately and therefore stand or fall together.  Claim 9 is representative and reads as                  
              follows:                                                                                                  
                     9.  A method for reducing free serum IgE in a human, comprising                                    
                     administering to said human an effective amount of a peptide comprising at least                   
              the first four amino acids from the N-terminal of SEQ.ID. NO:2 to reduce serum level of                   
              free IgE in said human.                                                                                   
                     SEQ ID NO:2 is a peptide having the sequence Leu-Lys-Ala-Met-Asp-Pro-Thr-                          
              Pro-Pro-Leu-Trp-Ile-Lys-Thr-Glu.  Specification, page 5, lines 20-21.  It corresponds to                  
              the fifteen amino acids at the N-terminus of LTNF.  Id., lines 13-21.  Thus, claim 9 is                   
              directed to a method of reducing the level of IgE in the serum of a human patient by                      
                                                                                                                        
              2 Figure 1 also purports to show IgE levels measured in certain experiments.  We do not credit the data   
              shown in the figure, however, because the specification provides no explanation of what the figure shows  
              or how the data were derived.  The figure does not show the same data as Table 4:  Table 4 shows seven    
              different measurements for each experiment while the figure shows only a single value for each            
              experiment.  In addition, the numbers shown in the y-axis of the figure do not correspond to any of the   
              values shown in Table 4.  Since the specification provides no meaningful explanation of what the figure   
              represents, the figure does not contribute to the sufficiency of the specification’s disclosure.          





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