Appeal No. 94-2894
Application 07/725,222
said drug depot containing a drug formulation comprising a transdermally
administrable pharmaceutically acceptable pharmaceutically active agent or a precursor
thereof, water and lower alkanol;
said active agent or precursor thereof being present in a pharmaceutically effective
amount;
said lower alkanol and said water being present in a volume:volume ratio of from
30:70 up to less than 95:5 such that said lower alkanol, water and drug are delivered to a
patient's skin, which patient has applied said system absent said removable covering layer
to said patient's skin, in amounts that said drug is delivered in a transdermally
administrable efficacious amount, said water has an activity at said patient's skin of about
0.4 to about 0.95 and said lower alkanol, at said patient's skin, has an activity of 0.3 to
about 0.9, and
wherein, once applied to said patient's skin, said lower alkanol has a flux from said
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system to said skin of at least 1500 mcg/cm /hr and through said skin of at least 1500
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mcg/cm /hr.
7. The system of claim 15 wherein said water and said lower alkanol are delivered
to said patient's skin so as to result in an ethanol activity of at least 0.5.
The examiner does not rely upon prior art references in rejecting the claims on
appeal. Rather, claims 2, 5 through 7, and 9 through 15 are rejected under 35 U.S.C. §
101 as claiming the same invention as that of claims 1 through 11 of U.S. Patent No.
5,064,654 ('654 patent). In addition, claims 2, 5 through 7, and 9 through 15 stand rejected
under 35 U.S.C. § 112, first and second paragraphs, as being nonenabled and indefinite.
We reverse each of these rejections. In addition, we make new grounds of rejection under
37 CFR § 1.196(b) and statements under 37 CFR § 1.196(c).
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