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ENABLEMENT – YOU
GOTTA HAVE IT
All patent
applications, including
provisional applications, must
teach enablement of the claimed
inventions. This is required by 35
U.S.C. §112, paragraph 1. See
provisional-patent and
the patent application.
The specification of the application
must describe the manner and process
of making and using the invention in
such full, clear, concise and exact
terms as to enable any person
skilled in the art to which it
pertains, or with which it is most
nearly connected, to make and use
the invention.
The court has boiled
this requirement down to the
“enablement requirement is satisfied
when one skilled in the art, after
ready the specification, could
practice the claimed invention
without undue experimentation”.
AK Steel, 344 F.3d 1234 at
1244 (F.C.C.A. 2003), In re Wands,
858 F.2d 731 at 736-37 (F.C.C.A.
1988).
The court in Wands,
discussed “undue experimentation”.
It requires analysis of
reasonableness having due regard for
the nature of the invention and
state of the art. The test is not
merely quantitative since a
considerable amount of
experimentation is permissible, it
is merely routine or if the
specification in question provides a
reasonable amount of guidance with
respect to the direction in which
the experimentation should
proceed.
It is important to
note that the claims of the
application define the invention.
During the prosecution of the
application, the claims often are
amended. It is essential that the
amended claims are enabled by the
original specification of the
application. Since enablement is a
question of law, it will not be
decided by the jury in an
infringement action. Since patents
are presumed valid, the infringer
has the burden of proving invalidity
by clear and convincing evidence.
Whether a claim is anticipated by
the prior, i.e., it is not new, is a
question of fact which can be
decided by a jury. To continue, the
scope of the patent is determined as
a question of law by the judge based
upon review of the claims. Whether
the claims, as determined by the
judge, have been infringed, is a
question of fact that can be decided
by a jury.
The point of all this
is that the court again recently
held the claims of a patent holder
invalid based upon a challenger
successfully demonstrating the
specification did not meet the
enablement test. Reference
Liebel-Flarsheim Company and
Mallinckrodt, Inc., v. Medrad,
Inc. 06-1156-1157
March 24, 2007
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