Appeal No. 2006-2471 Page 7
Application No. 09/824,364
Eisman states that the “cholesterol lowering agent and ACE inhibitor may be
employed together in the same dosage form or in separate oral dosage forms, which
may be taken at the same time.” Eisman, column 15, lines 60-63. A statin (i.e., an
inhibitor of HMG CoA reductase) is an example of a drug that lowers cholesterol. Id.,
column 7, lines 43-46; column 22, claims 2, 3, and 10. The indication is for
atherosclerotic diseases or intermittent claudication. Id., column 7, lines 40-45.
Next, the examiner introduced Shell as evidence. Shell describes drug
combinations that contain two or more drugs in the same dosage form. Shell, column 9,
lines 48-52. As example, the combination of an ACE inhibitor plus a diuretic is
disclosed. Id., column 10, lines 16-24. The patent states these “particular combinations
are useful in cardiovascular medicine, and provide advantages of reduced cost over
separate administrations of the different drugs, plus the particular advantage of reduced
side effects and enhanced patient compliance.” Id., column 10, lines 25-30.
There is no explicit teaching that a statin and aspirin be formulated together.
However, both Eisman and Shell put two drugs into the same dosage unit to treat a
cardiovascular indication, the same field of treatment as claimed here. In Eisman, one
of these drugs is a cholesterol-lowering drug, the same class of compounds recited in
the instant claims. Together, these establish that the concept of combining
cardiovascular drugs, including a cholesterol-lowering drug, in a single dosage form was
known prior to the application filing date. Shell puts into words reasons for it: to reduce
cost, to reduce side effects, and to increase patient compliance. Shell, column 10, lines
25-30. In our view, the skilled worker – knowing that statins and aspirin are used to
treat cardiovascular diseases – would have recognized the advantages of placing the
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