Appeal No. 1999-0494
Application 08/482,768
Johnson describes pharmaceutical compositions comprising cromolyn sodium
and a pharmaceutically acceptable carrier. See, e.g., column 1, lines 57-66 of Johnson.
The question becomes twofold. First, does Johnson describe a cromolyn sodium
containing pharmaceutical composition which contains cromolyn sodium in the
"therapeutically effective amount" of the claims? Second, is the cromolyn sodium
pharmaceutical composition described in Johnson "capable of crossing the blood-brain
barrier?"
In regard to the "therapeutically effective amount" language of claim 13 on
appeal, we note that the claim does not specifically state what the therapeutic effect of
the composition is to be. The claim language regarding inhibiting formation of amyloid
fibrils is directed to a property of the active agent, here, cromolyn sodium, not to the
amount of the active agent to be present in the composition. Thus, the pharmaceutical
composition described in Johnson, of necessity, contains a "therapeutically effective
amount" of cromolyn sodium, at least for the purposes described in Johnson. In other
words, the "therapeutically effective amount" language of claim 13 does not serve to
distinguish the claimed composition from those described in Johnson.
Turning to the other possible point of distinction between the respective
compositions, i.e., the requirement of claim 13 that the composition is capable of
crossing the blood-brain barrier, we note that Johnson does not discuss this property
whatsoever. However, this does not mean that claims 13-15 are patentably distinct
from the cromolyn sodium compositions described in Johnson.
Under these circumstances, it is reasonable to shift the burden to applicant to
provide evidence establishing in the first instance that the cromolyn sodium
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