Ex Parte De La Monte et al - Page 2


                   Appeal No. 2006-0275                                                                  Page 2                      
                   Application No. 09/964,667                                                                                        

                                                         BACKGROUND                                                                  
                           AD7c-NTP cDNA was isolated from a cDNA library prepared from the                                          
                   temporal lobe of an individual with end-stage Alzheimer’s disease.  Specification,                                
                   page 33.  According to appellants, the 1442-nucleotide AD7c-NTP cDNA “is an                                       
                   Alu sequence-containing gene” and “encodes a ~41 kD membrane spanning                                             
                   protein” (id., page 17).  AD7c-NTP is expressed in normal brain tissue, but                                       
                   “[q]uantitation of data obtained from 17 AD and 11 age-matched control brains                                     
                   demonstrated significantly higher levels of AD7c-NTP gene expression in AD.  In                                   
                   situ hybridization and immunostaining studies localized AD7c-NTP gene                                             
                   expression in neurons, and confirmed the over-expression associated with AD                                       
                   neurodegeneration . . . [These] results suggest that . . . abnormal expression of                                 
                   AD7c-NTP is a phenotype associated with Alzheimer’s disease.”  Id., page 18.                                      
                           In addition, various neuronal cell lines were stably transfected with AD7c-                               
                   NTP cDNA and examined for growth properties, morphology, and expression of                                        
                   AD7c-NTP.  Specification, pages 45 and 46.  “Over-expression of AD7c-NTP . . .                                    
                   resulted in significantly lower densities of viable cells in the cultures, despite                                
                   normal or elevated levels of DNA synthesis” (id., page 46).  The “[r]educed cell                                  
                   density in the cultures was caused by increased cell death” (id.), as shown by the                                
                   invariable presence of “numerous round, refractile floating [dead] cells” (id.).                                  
                   According to appellants, “[t]he attendant increase in nuclear p53 expression in                                   
                   AD7c-NTP transfected cells suggests that the cell death is likely to be mediated                                  
                   by apoptosis” (id.), i.e., that “over-expression of AD7c-NTP in neuronal cells                                    
                   causes apoptosis” (id., page 9).  Finally, viable cells in the AD7c-NTP transfected                               





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