Appeal No. 2003-1765 Page 3
Application No. 09/319,735
analgesic agent and a pharmaceutically acceptable excipient for topical administration.
The composition is intended for topical use, without systemic effectiveness - in keeping
with this, each of the claims requires that the excipient “not enhance transdermal or
transmucosal transmission of the opioid analgesic agent” (see claim 8). As explained in
the specification, such excipients “are substantially nonocclusive, and generally include
those which are water-soluble, such as oil-in-water emulsion bases (creams or
hydrophilic ointments) and water-soluble bases such as polyethylene glycol-based
vehicles and aqueous solutions gelled with various agents such as methylcellulose . . .”
(specification, page 10). The examiner does not address this aspect of the claims in
the statement of the rejection (except to assert that “MacLean teaches that the
composition can be administered in combination with pharmaceutically acceptable
carriers or diluents in a wide variety of dosage forms for oral, parenteral, or topical
administration” (answer, page 4)), but nevertheless concludes that “MacLean
anticipates the limitations of applicant’s composition claims” (id.).
Appellants argue that “the examiner appears to be overlooking the fact that
applicants’ claims require that the amount of active agent administered be ‘systemically
ineffective for induction of analgesia’” (Brief, page 3). In our view, this issue is not
relevant to these composition claims. MacLean broadly describes compositions
comprising opioid analgesics and “carriers and diluents” suitable for topical use. The
admonition in claim 8 that “a unit dosage,” i.e., the amount applied, contains a
systemically ineffective amount of the opioid analgesic, is tantamount to a statement of
intended use, rather than a physical limitation serving to distinguish over MacLean’s
composition. Nevertheless, as discussed above, claim 8 explicitly requires an excipient
that “does not enhance transdermal or transmucosal transmission of the opioid
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