Appeal No. 2006-3290 Page 9
Application No. 10/072,823
presented as drug products, non-drug products, and food products for possible
long term use.” All of the references relied upon by Examiner teach oridonin or
lupulone extracts from herbal medicine oriented plants. Ito distinguishes drugs
from herbal medicine oriented plants from “strong drugs with adverse reactions
[which] are used in the treatment of cancer . . . .” Therefore, unlike Exhibit 2’s
reference to chemotherapeutics that have a harmful effect on healthy cells, the
references relied upon by Examiner teach that oridonin is a “safe and effective”
agent (see e.g., ‘434, page 3 and ‘016, page 3); lupulone “is nontoxic and
harmless to the human body” (Matsui, page 10); and “it is known that the safety
of these plants and extracts is high” (Ito, paragraph 41).
Regarding the combination of oridonin and lupulone in a composition to
treat cancer, Ito teaches (paragraph 6), “[t]hese metastasis control substances
[(e.g., lupulone)] are used as complementary treatment agents for controlling the
metastasis before and after surgery or radiation treatment, and it is expected
they will also find use as a combination therapy agent.” According to Ito
(paragraph 43), “[t]here is no special limitation for other cited additives” when
lupulone is “used for preparation of the usual drugs, non-drugs, food products . . .
.” Therefore, contrary to Appellant’s assertion, Ito provides evidence to suggest
that lupulone can be combined with a variety of other ingredients without adverse
effect. Given that the references relied upon teach that oridonin and lupulone
have no harmful effect when administered, and the suggestion that lupulone can
be used as a complementary or combination drug, we find no error in Examiner’s
assertion that it would have been prima facie obvious to combine oridonin and
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