Appeal No. 2005-0548
Application No. 09/839,164
As indicated above, for purposes of this appeal, we will consider the issues only
as they apply to representative claim 30, although the indefiniteness issue here applies
to all the claims. We agree with the examiner that claim 30 is indefinite in that it is
incomplete. As pointed out by the examiner, a pharmaceutical composition must
include more than simply the mass otherwise one skilled in the art can not ascertain the
metes and bounds of the claim. For example, given the only mass as recited in claim
30 one has no way of knowing whether the claimed pharmaceutical composition is a
liquid or a solid. We recognize that the claim states that the composition is suitable for
subcutaneous administration; however, we point out that it nevertheless encompasses a
lyophilized alpha globin which can be reconstituted and administered subcutaneously.
If we assume, arguendo, that the appellants intend a pharmaceutical composition which
is in a liquid form, we would still find the claim incomplete. Lacking a volume as
suggested by the examiner (e.g., mg/ml), one skilled in the art cannot determine
whether a solution having 0.1 mg alpha globin/ml or 0.1 mg alpha globin/l, for example,
constitute pharmaceutical compositions within the scope of the claim.
Accordingly, in view of the foregoing, we find that the claims “fail to set out and
circumscribe a particular area with a reasonable degree of precision and particularity.”
In re Moore, 439 F.2d at 1235, 169 USPQ at 238.
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