Appeal No. 2002-1353 Page 3
Application No. 09/268,353
“[E]xcipients in tablets play various roles. . . . [T]hey are used above all to
facilitate the compression of the different ingredients in order to make a tablet
having good characteristics of hardness, disintegration and dissolution.” Id. The
specification discloses tablets comprising natural progesterone and estradiol and
“contain[ing] significantly lower quantities of excipients than tablets of the prior
art.” Page 5. Specifically, the tablets contain 20% or less by weight of
excipients, relative to the total dry matter of the tablet. See id.
Discussion
The claims are directed to tablets comprising synthetic natural
progesterone and estradiol, where the tablets have an excipient content of no
more than 20% by weight (based on total dry matter weight of the tablet) and a
disintegration time of less than 15 minutes.
The examiner rejected the claims as obvious in view of Gram. The
examiner characterized Gram as teaching tablets containing progesterone and
estradiol. Examiner’s Answer, page 3. The examiner acknowledged that Gram
does not teach tablets containing less than 20% by weight of excipients, or
tablets having a disintegration time of less than 15 minutes, but concluded that
the claimed tablets would have been obvious anyway. See the Examiner’s
Answer, page 3:
[T]he formulation of tablets having various disintegration times,
amounts of excipients, dissolution profile and hardness is well
known in the pharmaceutical art and, thus, is within the level of skill
of the ordinary artisan in the art (see for example Gram et al., page
2, paragraph #3; page 8, line 29 – page 10, line) [sic]. The
motivation to make tablets having various disintegration times,
amounts of excipients, dissolution profile and hardness is based on
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