Appeal 2007-3261
Application 09/854,802
total of release active ingredient after a specified time” (Reply Br. 12). As
shown in Lee,3 provided by the Examiner, “a typical release curve . . . shows
that the release vs. time is computed cumulatively and is not based on a
release within any period of time within the middle of the test” (Reply Br.
2).
With respect to the second ground, however, we concur with the
Examiner’s reasoning. The Examiner has the initial burden of presenting
evidence or reasons why a person skilled in the art would not recognize in an
applicant’s disclosure a description of the invention defined by the claims.
In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976). In this
case, the Examiner finds that the Specification describes “volume excipients,
gliding and lubricating excipients” (Spec. 7: 1-2) for the slow release layer.
However, the Examiner states the Specification does not teach the use of
these additives to obtain the rapid release profile required for the rapid
release cortex. (Answer 6). While there is no requirement that the invention
be claimed in the identical wording that was used in the specification, there
must be sufficient disclosure to show one of skill in this art that the inventor
“invented what is claimed.” See Union Oil Co. of California v. Atlantic
Richfield Co., 208 F.3d 989, 1000, 54 USPQ2d 1227, 1235 (Fed. Cir. 2000).
In view of the lack of literal support for the limitation, it is our opinion that
the Examiner has reason to question the written description for the recited
limitation, shifting the burden to Appellant to rebut it. Because Appellant
does not address this deficiency in either the Substitute Appeal Brief or
2 This is a reference to the Reply Brief dated Feb. 5, 2007.
3 Lee, Int. J. Pharmacol., 188: 71-80 (1990).
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