Ex Parte Krieger et al - Page 6


                     Appeal No. 2006-1993                                                                            Page 6                         
                     Application No. 10/147,651                                                                                                     

                              While the examiner engages in a Wands analysis, see In re Wands, 858                                                  
                     F.2d 731, 737, 8 USPQ2d 1400, 1403 (Fed. Cir. 1988) (noting that facts that                                                    
                     should be considered in determining whether a specification is enabling include:                                               
                     (1) the quantity of experimentation necessary to practice the invention, (2) the                                               
                     amount of direction or guidance presented, (3) the presence or absence of                                                      
                     working examples, (4) the nature of the invention, (5) the state of the prior art, (6)                                         
                     the relative skill of those in the art, (7) the predictability or unpredictability of the                                      
                     art, and (8) the breadth of the claims), the examiner’s primary concern appears to                                             
                     be that “[t]he specification, however, discloses only one mouse that exhibits this                                             
                     claimed combination of genotype and phenotype, that is a transgenic mouse                                                      
                     whose genome comprises a homozygous disruption of SR-BI and ApoE.”                                                             
                     Examiner’s Answer, page 4.  According to the examiner, “[t]here is no disclosure                                               
                     in the specification that other mice are available with decreased expression of                                                
                     active SR-BI and ApoE that develop atherosclerotic plaques in the aortic sinuses                                               
                     and progressive heart block.”  Id.  The examiner, however, provides no evidence                                                
                     that it would require an undue amount of experimentation to produce additional                                                 
                     knockout mice and test them for the phenotype required by the claims.                                                          
                              The examiner notes that single knockout mice are reported in the                                                      
                     specification, but that no analysis of the genotypes of those mice is reported.                                                
                     See id. at 5.  The examiner thus concludes that “there is no guidance in the                                                   
                     specification for a mouse with decreased expression of active SR-BI and Apo-E                                                  
                     that develop atherosclerotic plaques in the aortic sinuses and progressive heart                                               
                     block other than the SR-BI -/- ApoE -/- mouse.”  Id.                                                                           





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