In This Issue
· Federal
Circuit, Inter Alia, Reverses
District Court Finding Of Indefiniteness And Noninfringement Of Ethicon Utility
Patents
· Federal
Circuit Clarifies That The Presumption Of Patent Validity Does Not Apply In An Ex Parte Reexamination
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Federal
Circuit, Inter Alia, Reverses District Court Finding Of Indefiniteness And Noninfringement
Of Ethicon Utility Patents
In the appeal
from the U.S. District Court for the Southern District of Ohio in Ethicon Endo-Surgery, Inc. v. Covidien,
Inc., the Court of Appeals for the the Federal Circuit (“CAFC”), inter alia, reversed the District
Court’s finding of: (i) invalidity for indefiniteness of U.S. Patent No. 8,182,501
(“the ‘501 patent”); and (ii) noninfringement of U.S. Patent No. 5,989,275 (“the
‘275 patent”).
The asserted
Ethicon utility patents are directed to surgical instruments that use
ultrasonic energy created by high frequency vibrating blades to cut tissue
and blood vessels, and when pressed against the blood vessel walls, the
vibrating blades cause blood to coagulate thereby sealing the blood vessels and
preventing bleeding. Both Ethicon and
Covidien develop and market such devices. After Covidien launched a competing line of ultrasonic surgical
equipment, Ethicon filed suit alleging infringement of the ‘501 patent and
the ‘275 patent. After the close of
discovery, the District Court granted summary judgment finding, inter alia, the ‘501 patent is invalid
as indefinite and the ‘275 patent not infringed. Ethicon appealed.
Each of the
asserted claims of the ‘501 patent includes a limitation requiring clamping
pressure values in a range. The
asserted claims specifically recite either an “average” clamping/coaptation
pressure or simply a “clamping pressure.” The ‘501 patent specification uses “clamping pressure” interchangeably
with “average” clamping/coaptation pressure, and describes the “exert
coaptation pressure” step as the exertion of “an average coaptation pressure
on the blood vessel between and including 60 psi and 210 psi.”
The District
Court held the asserted claims of the ‘501 patent invalid as indefinite on
the grounds that nothing in the specification or in the state of the art
specified “a method of measurement, the location of measurement, and the type
and amount of tissue used for the measurement of clamping forces and clamping
pressures.” The District Court further
noted that “measuring at different locations along the clamp arm provided
different force and pressure values” and “when the clamp arm was fully
engaged with tissue, the tissue could be thin or thick, stiff or
compressible, and depending on the type of tissue, the measurement of the
clamping force and pressure would differ.”
On appeal, Ethicon
argued that the District Court ignored the proffered evidence and improperly
resolved disputed issues in favor of movant Covidien. Ethicon further argued that one skilled in
the art reading the ‘501 patent specification would understand that the clamping
force measurements recited in the claims must be made when the clamping arm
and blade are in a closed position, and in a manner that reflects the average
pressure applied by the clamping arm on the clamping surface, which can be
measured at the midpoint of the recited clamping surface area.
The CAFC
agreed with Ethicon, noting that a finding of indefiniteness was reviewed de novo and only proper where a claim,
when read in light of the specification and prosecution history, failed to
inform skilled artisans about the scope of the invention with reasonable
certainty. The CAFC also observed that
the ‘501 patent specification made clear that the claimed clamping or
coaptation pressure on the blood vessel is an average pressure that should be
measured when the clamping arm and the blade are in a closed position and
exerting pressure on a blood vessel disposed between them.
The CAFC further
discussed that, although the ‘501 patent specification disclosed four (4)
techniques to measure pressure, the District Court ignored expert testimony
that each of these methods was designed to provide the same clamping force
measurement, and that while there may have been slight variation(s) between
the methods, any variation(s) are simply due to natural variances in
real-world testing conditions. The
CAFC ultimately concluded that the definiteness requirement of 35 U.S.C §112 only
requires that one skilled in the art must be able to understand which
pressures are relevant to the claims and how these pressures are to be
measured, so as to discern the scope of the claimed average pressure, and that
if these requirements are satisfied—there is no requirement for the
specification to identify a particular measurement technique. The CAFC accordingly reversed the District
Court’s summary judgment of indefiniteness.
The ‘275
patent similarly claims a particular configuration of an ultrasonic surgical
shears device that generates and then propagates ultrasonic energy to the
clamping end of the device while dampening undesired vibrations. Only vibrational motions directly forward
and backward along the transmission rod axis towards the blade and clamping
arm are desirable because transverse motion can lead to suboptimal
performance; to reduce undesirable transverse vibrational motion, the device
includes a damping sheath that “loosely surrounds” the transmission rod.
After the
close of discovery, Covidien also filed a summary judgment motion seeking noninfringement
of the asserted claims arguing that the damping sheath surrounding the
transmission rod of its shears is not “configured to loosely contact” the
transmission rod or “adapted to absorb undesired vibrations.” The District Court construed “configured to
loosely contact” as “structured to have contact other than at fixed support
points, but not tightly fitted” and granted summary judgment of
noninfringement.
On appeal,
Ethicon asserted that: (i) the District Court improperly imported a
limitation into the term inconsistent with its ordinary meaning improperly
resolved issues of fact and conflicting expert testimony in Covidien’s favor;
and (ii) “loose contact” is contact “other than at fixed support points.”
.
In finding
for Ethicon, the CAFC observed that the claims recite that the damping sheath
surrounding the transmission rod “loosely contacts the transmission rod over
a portion of the transmission rod,” and that the recitation of “over a
portion” suggests that such “loose contact” is not contact only at discrete
fixed points. The CAFC further
observed that the ‘271 patent specification reinforces an understanding that
a longitudinal slit extends along the damping sheath from one end to the
other in order to allow the sheath to fit over the transmission rod, and that
without this slit, the damping sheath “may not be able to loosely contact the
transmission rod” over its cross-sectional diameter.
The CAFC then
noted that there was contradictory expert testimony as to whether the sheath
of the accused device would “loosely contact” the transmission rod, and that
the District Court’s finding did not take into account contrary evidence from
Ethicon’s expert showing that the sheath of Covidien’s accused shears appears
to contact the transmission rod at points other than the nodal ribs during
operation. Given the contradictory
expert testimony, the CAFC, taking all inferences in favor of non-movant Ethicon
on motion for summary judgment, vacated the District Court’s finding of noninfringement.
Federal Circuit Clarifies That The
Presumption Of Patent Validity Does Not Apply In An Ex Parte Reexamination
In Dome Patent L.P. v. Lee, the
CAFC clarified that when the U.S. Patent and Trademark Office (“USPTO”)
institutes an ex parte reexamination,
the prosecution is “reopened” to determine whether the claimed subject matter
should have been allowed in the first place, such that the presumption of
validity for an issued patent is no longer applicable.
Dome’s U.S. Patent No. 4,306,042 (“’the ‘042 patent”) issued in 1981 and
expired in 1998. In December 1997,
Dome sued six parties for infringement of the ‘042 patent, and one of the
defendants sought an ex parte reexamination,
which was granted in 1999; the District Court stayed the lawsuit pending resolution
of the reexamination. The USPTO issued
the reexamination certificate in 2007 finding several claims patentable, but cancelling
independent claim 1 as obvious under 35 U.S.C. § 103. Thereafter, Dome filed a Section 146 action
in the U.S. District Court for the District of Columbia challenging the
USPTO’s findings, and the District Court affirmed.
Dome then appealed to the CAFC, arguing that the District Court erred in
affirming the finding of obviousness because the USPTO applied a
“preponderance of the evidence” standard, and not the more onerous “clear and
convincing evidence” standard. Dome
specifically asserted that, while the USPTO need only show unpatentability by
a preponderance of the evidence in reexamination, this was a different
situation because the ‘042 patent was an issued patent such that the statutory
presumption of validity applied requiring application of the “clear and
convincing” standard per typical patent litigation practice.
The CAFC affirmed the District Court, noting that “[w]hen the Patent
Office institutes ex parte reexamination, it reopens prosecution to determine
whether the claimed subject matter should have been allowed in the first
place. At that point, there is no need
to presume that the Patent Office had ‘done its job’ in the previous
examination. Accordingly, the
presumption of validity is no longer applicable.”
The CAFC observed that this conclusion aligns with the purpose of
reexamination, including allowing the USPTO to take a second look at patents
thought “doubtful,” And that “[i]n a very real sense, the intent underlying
reexamination is a ‘start over.’” The
CAFC then held that this intent would be hindered if a district court was
required to presume that a reexamined claim is valid simply because of the
USPTO’s previous determination, which would inappropriately impose a burden
on the USPTO to defend its own subsequent decision of invalidity on reexamination
decision by clear and convincing evidence. |