Appeal No. 2006-1304 Page 9
Application No. 10/214,058
and less new lesion formation . . . was observed if co-treated with CCBs as compared to
PRAV [pravastatin] alone. . . . This is the first report which shows that CCBs act
synergisticly [sic] with lipid lowering therapy to retard the progression of coronary
atherosclerosis.”
We therefore conclude that a person of ordinary skill in the art would have been
led by Jukema to combine atorvastatin and amlodipine to make a pharmaceutical
composition for treating coronary atherosclerosis. The skilled artisan would have been
motivated to make the combination by Jukema’s positive results in combining CCBs and
pravastatin, the limited genus of specific CCBs disclosed by Jukema, and the
recognition by those in the art that statins as a group are HMG-CoA reductase inhibitors
and potent lipid lowering agents.
Appellant argues that “Jukema actually teaches away from the specific claimed
combination,” because “patients receiving the combination of a CCB with pravastatin
experienced more adverse ‘clinical events’ as compared to patients that received
pravastatin alone.” Appeal Brief, pages 10 and 11.
We do not find this argument persuasive. Jukema acknowledges the increased
“clinical events” experienced by patients receiving CCBs but attaches no significance to
that finding. See page 428, right-hand column (“not statistically significant”). Jukema
also explains that the result is largely due to an increase in unscheduled coronary
bypass operations in patients taking non-dihydropyridine CCBs; that is, the group of
CCBs that does not include amlodipine. See id. Thus, if the number of clinical events
would have had any effect, it would have been to steer those skilled in the art toward
dihydropyridine CCBs such as amlodipine. Finally, Jukema states that the “apparent
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