Appeal No. 1996-2468
Application 08/091,899
Moreover, the appellant submits Zuckerman to show that indomethacin has been
shown to inhibit the activity of prostaglandins and stop uterine contractions in in vivo clinical
trials of women in premature labor. It is argued that in view of “the demonstrated effect of
IGF-I on placental production of prostaglandin PGF and thromboxane, in view of the art
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recognized action of PGF for labor regulation previously described using indomethacin,
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establish a reasonable correlation between the use of IGF-I and the inhibition of labor.”
Brief, page 27.
The examiner responds to this argument, arguing indomethacin has a different
pharmacologic profile than indomethacin. We believe, however, that the evidence of
record adequately supports agreement in activity of IGF-I and indomethacin, at least with
respect to inhibition of prostaglandin and thromboxane.
We also find there to be literal support in the specification for the in vivo “how to
use” requirement. Example 7 of the specification demonstrates “that IGF-I specifically
inhibits vasoconstrictive prostanoid production by human placental explants in a dose
related manner, and that the active doses are well within the physiological range.
Therefore, appropriate doses of IGF-I may be determined for human use in the inhibition of
labor using standard pharmacological parameters known to those of skill
in the art to provide the described inhibition of thromboxane and prostaglandin F by
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placenta in vivo.” Specification, p. 51. Appellant appears to have adequately
demonstrated extrapolation of the in vitro model to in vivo use as it pertains to
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