Appeal No. 2004-0394 Page 8
Application No. 09/915,467
if taken by a woman who [is] pregnant,” and therefore teaches, “[t]he
incorporation of oral contraceptive medication would eliminate the
potential for pregnancy while medicated.” Note again, by way of
illustration, that claim 11 of Abrams is drawn to “[a] pharmaceutical
delivery package comprising a mixture of [i]sotretinoin and an oral
contraceptive.”
Accordingly, Abrams recognizes the need – the severe danger of isotretinion if taken by
a woman who is pregnant; and satisfies the need – a pharmaceutical delivery package
(a pharmaceutical composition), comprising a mixture of isotretinioin and an oral
contraceptive.3 Appellant’s claim 6 is drawn to a pharmaceutical composition
comprising a unit dose form4 of a teratogen (e.g. isotretinoin, see appellant’s claim 9),
and a contraceptive. Contrary to appellant’s assertion (Request, page 6), Abrams
supports our finding of fact and conclusion of law.
Furthermore, as set forth at page 11 of the Decision, “Elsayed discloses the
need to provide educational materials to both the consumer and distributor, as well as,
providing isotretinion together with a contraceptive device or formulation.” See also
Decision, pages 3-4. Note as set forth at page 3 of the Decision, “Elsayed discloses
(column 3, lines 26-31), … the methods of the present invention may be desirably and
advantageously used to educate and reinforce the actions and behaviors of patients
who are taking the drug….” In addition, as set forth on pages 3-4 of the Decision,
Elsayed discloses (column 9, lines 21-29),
The drug is preferably supplied to the pharmacy (as well as the
patient) in packaging, such as individual blister packs, which
includes warnings regarding the risks associated with the drug, as
well as the importance of various aspects of the present methods
3 We note that appellant does not maintain his assertion that Abrams does not contain an enabling
disclosure. Cf. Brief, pages 3-4.
4 According to appellant’s specification, page 13, “[t]he term unit dose form means in a form wherein both
components are intended to be taken together as one big pill or as two small pills together.” Appellant
recognizes (Brief, page 4) that Abrams discloses “combining the two components into a unitary pill,” e.g.,
“one big pill.” Cf. Decision page 10.
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