Appeal 2007-3261
Application 09/854,802
95% of the melatonin is released within 10 minutes in an
oscillating tray containing gastric/intestinal juice at 37°C.
DISCUSSION
Enablement rejection
The Specification provides one working example of a controlled
release melatonin tablet comprising a slow release nucleus and a fast release
cortex as recited in claim 16 (Spec. 7-8). The Examiner contends that the
Specification is only enabled for this single embodiment, but does not enable
other formulations (Answer 4). Thus, the Examiner concludes that the
Specification is not in incompliance with the enablement requirement of §
112, first paragraph, because it does not enable persons of skill in the art to
make and use the full scope of the claims (Answer 4).
“To be enabling, the specification of a patent must teach those skilled
in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In
re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).
In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), a number
of factors were set forth which may be considered in determining whether a
disclosure would require undue experimentation. These factors are as
follows: (1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior art, (6) the
relative skill of those in the art, (7) the predictability or unpredictability of
the art, and (8) the breadth of the claims. Wands, 858 F.2d at 737,
3
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: September 9, 2013