Appeal No. 2006-1304 Page 8
Application No. 10/214,058
This interpretation is confirmed by the Orekhov abstract.6 The Orekhov abstract
states that “[i]n the frame of the Regression Growth Evaluation Statin Study
(REGRESS) trial synergistic anti-atherogenic effect of lipid antagonists has recently
been shown.” The researchers “tried to elucidate the mechanism of more pronounced
effect of statin-calcium antagonist combination on atherosclerotic lesion.” Even though
they were building on the REGRESS trial, however, the authors did not use the
pravastatin that had been used in that trial; instead, they used another statin
(lovastatin). The Orekhov abstract therefore provides evidence that those skilled in the
art considered pravastatin and lovastatin to be equivalents. In addition to the instant
specification’s statement that all statins are HMG-CoA reductase inhibitors and lipid-
lowering agents, the abstract provides further evidence that those skilled in the art
considered statins to be equivalents for purposes of lipid-lowering therapy.
Finally, Jukema 19957 provides further evidence that those skilled in the art
would have interpreted Jukema’s results to be significant, notwithstanding the caveats
attached to the Jukema paper. Jukema 1995 presents the results of a review of the
REGRESS trial data and reports that in patients taking pravastatin “less progression . . .
6 Orekhov et al., “Anti-atherogenic effect of calcium antagonist plus statin combination,” Cardiovascular
Drugs and Therapy, Vol. 11, pp. 350 (1997). The Orekhov abstract is cited in the specification (page 5)
and was submitted in the Information Disclosure Statement filed January 15, 2003. We note that this
reference, an abstract, was published before the effective filing date of the present application, in contrast
to the full-text Orekhov paper (Orekhov et al, “Antiatherosclerotic and antiatherogenic effects of a calcium
antagonist plus statin combination: amlodipine and lovastatin,” Int’l Journal of Cardiology, Vol. 62 (Suppl.
2), pp. S67-S77 (Dec. 31, 1997)). See the Supplement to Appeal Brief, filed January 11, 2005, page 3.
7 Jukema et al., “Evidence for a synergistic effect of calcium channel blockers with lipid lowering therapy
in retarding progression of coronary atherosclerosis in symptomatic patients,” Circulation, Suppl. 1, pp.
I-197 (1995). Jukema 1995 appears to be an abstract of a presentation at a meeting (the top of the page
bears the heading “Abstracts from the 68th Scientific Sessions”) that summarizes the results presented in
the Jukema paper, published in 1996. Jukema 1995 was cited in the specification (page 5) and made of
record in the IDS filed January 15, 2003.
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