Appeal No. 2004-0543 Page 6
Application No. 10/010,678
usually used for their local effects and thus are most commonly used to treat superficial
skin disorders . . . depending on the consistency of [ ] inactive substances, the
formulation may be an ointment, a cream, a lotion, a solution, a powder or a gel@ (id.,
page 3, emphasis added). Under the heading ATransdermal Route,@ the manual
teaches that A[s]ome drugs are delivered bodywide through a patch on the skin. These
drugs, sometimes mixed with a chemical (such as alcohol) that enhances penetration of
the skin, pass through the skin to the bloodstream without injection. Through a patch,
the drug can be delivered slowly and continuously for many hours or days . . . As a
result, levels of a drug in the blood can be kept relatively constant@ (id., pages 3-4).
Having reviewed the evidence of record, we find that the terms transdermal
administration and topical administration are not always mutually exclusive. That is,
while transdermal administration of a substance results in systemic administration
(Athrough-the-skin@ administration), topical administration can result in strictly local, or
systemic administration B depending upon the carrier used. In other words, topical
administration can, in some circumstances, include transdermal administration. Thus,
the issue comes down to what Rasmusson means by Atopical@ administration.
Rasmusson describes Aa method of treating the hyperandrogenic conditions of
androgenic alopecia, including male pattern alopecia, acne vulgaris, seborrhea, and
female hirsutism by topical administration, and a method of treating all of the above
conditions as well as benign prostatic hypertrophy, by systemic administration@ of 5
alpha reductase inhibitors (page 6, emphasis added). According to Rasmusson,
Atopical pharmaceutical compositions may be in the form of a solution, cream, ointment,
gel, lotion, shampoo or aerosol formulation adapted for application to the skin@ (id.),
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