Appeal No. 2004-0543 Page 5
Application No. 10/010,678
Appellants rely on two forms of evidence in support of their position: their original
disclosure, and an excerpt from The Merck Manual.3 With respect to their original
disclosure, appellants argue that Athe fact that [ ] transdermal administration and topical
administration [are taught] in two different paragraphs [on page 6] suggests that the two
routes of administration are not interchangeable@ (Brief, page 7). Nevertheless, we find
that there is some overlap between the two terms as they are used in the specification.
That is, the specification teaches that Atransdermal@ administration is systemic and
Acontinuous rather than intermittent@ (Specification, page 7), but does not restrict
Atopical@ administration to local or intermittent administration. As used in the
specification, Atopical@ administration can also include systemic administration: for
example, the specification teaches that A5α-reductase 2 inhibitor compounds . . . can be
administered in a wide variety of therapeutic dosage forms in conventional vehicles for
systemic administration. For example, the compounds can be administered in such oral
dosage forms as tablets, capsules [ ], pills, powders, granules, elixirs, tinctures,
solutions, suspensions, syrups and emulsions. Likewise, they may also be
administered in intravenous [form], intraperitoneal [form], subcutaneous [form], topical
[form] with or without occlusion, or intramuscular form . . .@ (Page 6, emphasis added).
Similarly, The Merck Manual teaches that drugs Amay be applied to the skin
(cutaneously) for a local (topical) or bodywide (systemic) effect; or delivered through the
skin by a patch (transdermally) for a systemic effect@ (Appendix II, page 1). Under the
heading ACutaneous Route,@ the manual indicates that A[d]rugs applied to the skin are
3 The Merck Manual, Second Home Edition, Chapter 11, Drug Administration and Kinetics,
Thomas N. Tozer, Ph.D., Drug Administration, Appendix I; submitted with appellants= Brief as Appendix II,
and available at http:// www.merck.com/pubs/mmanual_home2/sec02/ch011/ch011b.htm .
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