from the United States District Court for the Eastern
District of Virginia in No. 2:13-cv-00486-HCM-DEM, Senior
Judge Henry C. Morgan Jr.
CONSTANTINE L. Trela, Jr., Sidley Austin LLP, Chicago, IL,
argued for plaintiff-appellee. Also represented by Joshua
John Fougere, Washington, DC; Michael Songer, Vincent John
Galluzzo, Michael H. Jacobs, Crowell & Moring, LLP,
Washington, DC; STEPHEN Edward Noona, Kaufman & Canoles,
P.C., Norfolk, VA.
M. Desmarais, Desmarais LLP, New York, NY, argued for
defendant-appellant. Also represented by Paul a. bondor,
dustin guzior, laurie stempler; jeffrey Howard Lerner, George
Frank Pappas, Gary Rubman, Covington & Burling LLP,
Prost, Chief Judge, Reyna and Chen, Circuit Judges.
LifeCell Corporation ("LifeCell") appeals from a
final judgment of the U.S. District Court for the Eastern
District of Virginia entered in favor of Plaintiff-Appellee
LifeNet Health ("LifeNet"). Following claim
construction and trial, a jury found LifeNet's U.S.
Patent No. 6, 569, 200 ("'200 patent")
infringed by LifeCell and not invalid. The district court
denied LifeCell's motion for a new trial and renewed
motion for judgment as a matter of law ("JMOL") on,
inter aha, claim construction, non-infringement, and
invalidity. The district court subsequently entered a final
judgment consistent with the jury's findings on
infringement, validity, and damages. We affirm.
'200 patent claims plasticized soft tissue grafts
suitable for transplantation into humans. Such grafts are
useful in various medical, orthopedic, dental, and cosmetic
surgery applications. The '200 patent explains that
tissue grafts are typically preserved and provided in a
dehydrated state, such as through freeze-drying, then
rehydrated before implantation. The patent explains that the
freeze-drying process is not optimal: it can cause the tissue
to become brittle with a tendency to fracture; it requires
time in the operating room to rehydrate the tissue; and even
after rehydration the tissue's properties do not
approximate that of normal tissue, and the graft can fail.
'200 patent's "plasticized" tissue grafts
avoid these problems. The tissue is preserved not by
freeze-drying but by replacing the tissue's water with
biocompatible plasticizers, such as glycerol, that provide
the hydrating functions of water. These plasticized grafts
exhibit properties similar to that of normal tissue and avoid
the rehydration process required for freeze-dried tissue.
specification explains that, while the plasticizers
can be removed prior to implantation, they need not
be. It therefore discloses various options for the implanting
clinician: (1) "direct implantation of the grafts
without further processing following removal from the
packaging"; (2) "implantation following a brief
washing in sterile isotonic saline to remove any remaining
traces of plasticizer associated with the immediate surfaces
of the grafts"; or (3) "implantation following an
extended (approximately 1 hour) washing with sterile isotonic
saline to remove as much plasticizer as possible."
'200 patent col. 12 ll.9-16.
asserted claims 1-4, 7, 8, and 10 in this case. Claims 1-4
are apparatus claims, while claims 7, 8, and 10 are method
claims. All of the asserted claims require that "one or
more plasticizers are not removed from [an] internal matrix
of [the] plasticized soft tissue graft prior to
transplantation into a human" (or "the non-removal
limitation"). For example, claim 1 recites:
1. A plasticized soft tissue graft suitable for
transplantation into a human, comprising:
a cleaned soft tissue graft having an internal matrix; and
one or more plasticizers contained in said internal matrix;
said one or more plasticizers are not removed from said
internal matrix of said plasticized soft tissue graft prior
to transplantation into a human.
Id. at col. 24 ll. 10-16 (emphasis added).
non-removal limitation was added to the claims during
prosecution in response to a rejection based on the Cavallaro
reference, U.S. Patent No. 5, 718, 012 ("'012
patent"). Cavallaro also discloses using plasticizers in
tissue constructs. In Cavallaro, the plasticizers are used to
improve the tensile strength of collagen threads, and after
such "conditioning treatment, the plasticizer must ...
be removed." '012 patent col. 7 ll. 40-43. Following
the examiner's rejection for anticipation by Cavallaro,
LifeNet amended its claims to add the requirement that
"one or more plasticizers are not removed from an
internal matrix of [the] plasticized soft tissue graft prior
to transplantation into a human." J.A. 192. As support
for the amendment, LifeNet recited the following language
from the specification: "Replacement of the chemical
plasticizers by water prior to implantation is not required
and thus, the . . . soft tissue plasticized product can be
place[d] directly into an implant site without . . . ."
J.A. 193 (first and third alterations in original).
accused products are soft tissue grafts preserved in a
plasticizer solution called Solution E. It is undisputed that
users of the accused products are instructed to soak the
tissue grafts in saline solution for a minimum of two minutes
prior to implantation and that a significant amount of
plasticizers are removed during this two-minute rinse.
LifeCell contends there is no evidence to suggest that
surgeons have ever implanted the accused products without
following those instructions.
claim construction proceedings, the parties disputed the
meaning of several terms, including the non-removal
limitation. The parties' dispute at the time centered on
the degree of plasticizer removal-whether this limitation
required that no plasticizer be removed
(LifeCell's position) or allowed for some, but not all,
plasticizer to be removed (LifeNet's position).
Specifically, LifeCell's proposed construction was that
"no processing steps are taken, before transplantation
into a human, that result in any amount of the one
or more plasticizers being taken out of the internal matrix
of the plasticized soft tissue graft." J.A. 409
(emphasis added). LifeNet proposed that the term meant
"without complete replacement of the
plasticizer or plasticizers in the internal matrix of the
tissue graft prior to direct implantation into a human."
Id. (emphasis added). The district court concluded
in its Markman order that construction of the entire
term was "unnecessary, " observing that the
two-word phrase "'not removed' is easily
understood by a person of ordinary skill in the art to have
its plain meaning that no plasticizers are removed prior to
transplantation." J.A. 65. The district court later
denied LifeCell's motion for summary judgment that this
limitation rendered claims 1-4 indefinite for allegedly
including a method step in an apparatus claim.
trial, LifeCell argued non-infringement based on evidence
showing that as much as 50% of the plasticizer in the accused
products is removed during the two-minute saline rinse.
According to LifeCell, this undisputed removal of
plasticizers meant that its products do not meet the claim
limitation requiring that plasticizers are "not
removed." In response, LifeNet did not dispute that
plasticizers are removed from the accused tissue grafts
during the two-minute rinse but maintained that no
plasticizers are removed from the internal matrix of
the tissue graft, as recited in the non-removal limitation.
According to LifeNet's expert, Dr. David Kaplan, the only
plasticizer removed during the ...