Appeal No. 2004-0394 Page 9
Application No. 09/915,467
such as, for example, pregnancy testing and the use of
contraception (in the case of teratogenic drugs), and the dangers
associated with sharing the drug with others, among other aspects.
At page 4 of the Decision, “we note that the last two steps (step g and step h) of the
Elsayed method require (step g) pharmacies to fill prescriptions for non-pregnant
patients, and (step h) provide patients who are capable of becoming pregnant a
contraceptive device or formulation. See e.g., Elsayed, claim 1 and claim 10.”
Accordingly, Elsayed recognizes the need5; and satisfies the need6 – provide
educational materials to both the consumer and distributor, as well as, providing the
drug with warnings regarding the risks associated with teratogenic drugs7, together with
a contraceptive device or formulation.
Appellant’s claim 1 is drawn to an educational article of manufacture, wherein a
teratogenic pharmaceutical is packaged together with a contraceptive and labeling
specifying avoidance of pregnancy while using the teratogenic pharmaceutical. The
only difference between claim 1 and Elsayed, is that while Elsayed provides patients
who are capable of becoming pregnant a contraceptive device or formulation together
with a teratogenic drug; Elsayed does not expressly state that the two components are
“packaged together.” However, as set forth on page 5 of the Decision, alteration
5 “It is undisputed that the prior art acknowledges a long-felt need for the problem of teratogen-related
birth defects.” Request, page 2.
6 See Decision, page 3 (footnote omitted):
According to Elsayed (column 1, lines 48-57),
… A pregnancy prevention program was developed, and the Slone Epidemiology
Unit of Boston University designed and implemented a survey to evaluate these
efforts. The survey identified relatively low rates of pregnancy during Accutane
treatment, which suggests that such a program can be effective.
7 As set forth on page 2 of the Decision, according to appellant’s specification (page 7),
the term ‘teratogenic’ … include[s] pharmaceuticals associated with an increased risk of
birth defects. The term thus includes pharmaceuticals with FDA-approved labeling citing
an increased risk of birth defects as a potential side effect. Such teratogenic
pharmaceuticals currently listed in the PHYSICIANS’ DESK REFERENCE (Medical
Economics Company, publ. 2000) include, for example, isotretinoin (ACCUTANE®)….
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