Lifenet Health v. Lifecell Corporation , 837 F.3d 1316 ( 2016 )

United States Court of Appeals
for the Federal Circuit
______________________
LIFENET HEALTH,
Plaintiff-Appellee
v.
LIFECELL CORPORATION,
Defendant-Appellant
______________________
2015-1549
______________________
Appeal 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.
______________________
Decided: September 16, 2016
______________________
CONSTANTINE L. TRELA, JR., Sidley Austin LLP, Chi-
cago, 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.
JOHN 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, Washington, DC.
2 LIFENET HEALTH v. LIFECELL CORP.
______________________
Before PROST, Chief Judge, REYNA and CHEN, Circuit
Judges.
PROST, Chief Judge.
Defendant-Appellant 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 alia, claim construc-
tion, 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.
BACKGROUND
LifeNet’s ’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 rehy-
drate the tissue; and even after rehydration the tissue’s
properties do not approximate that of normal tissue, and
the graft can fail.
The ’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 biocompat-
LIFENET HEALTH v. LIFECELL CORP. 3
ible plasticizers, such as glycerol, that provide the hydrat-
ing functions of water. These plasticized grafts exhibit
properties similar to that of normal tissue and avoid the
rehydration process required for freeze-dried tissue.
The 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 plasti-
cizer associated with the immediate surfaces of the
grafts”; or (3) “implantation following an extended (ap-
proximately 1 hour) washing with sterile isotonic saline to
remove as much plasticizer as possible.” ’200 patent col.
12 ll. 9-16.
LifeNet 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] inter-
nal 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 in-
ternal 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).
4 LIFENET HEALTH v. LIFECELL CORP.
The 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 inter-
nal 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).
LifeCell’s accused products are soft tissue grafts pre-
served in a plasticizer solution called Solution E. It is
undisputed that users of the accused products are in-
structed 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.
During 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,
LIFENET HEALTH v. LIFECELL CORP. 5
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 replace-
ment 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 mean-
ing that no plasticizers are removed prior to transplanta-
tion.” J.A. 65. The district court later denied LifeCell’s
motion for summary judgment that this limitation ren-
dered claims 1-4 indefinite for allegedly including a
method step in an apparatus claim.
At 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 rinse is “nonbound” plasti-
cizer that exists in the gaps and voids of the tissue grafts,
not plasticizer “bound” to the graft’s internal matrix. J.A.
8230-31.
After a two-week trial, the jury found that LifeCell’s
accused tissue grafts infringed the ’200 patent. It also
found that LifeCell had failed to establish any of its
invalidity defenses and awarded LifeNet $34,741,971 in
damages. After briefing and oral argument, the district
6 LIFENET HEALTH v. LIFECELL CORP.
court denied LifeCell’s post-trial motions. LifeCell timely
filed this appeal.
We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a)(1).
DISCUSSION
LifeCell raises several issues on appeal. First, it
submits that the district court erred by allowing the jury
to resolve a dispute about the scope of the limitation “said
one or more plasticizers are not removed from [an] inter-
nal matrix of [the] plasticized soft tissue graft” and that,
because the accused products do not meet this limitation,
JMOL of non-infringement is warranted. LifeCell also
argues that JMOL of no direct infringement is warranted
because, regardless of how the limitation is construed,
LifeCell itself does not directly infringe; rather, independ-
ent surgeons or their assistants prepare the grafts for
transplantation. LifeCell further argues that claims 1-4
are invalid as indefinite for covering both an apparatus
and, through the non-removal limitation, a method of
using that apparatus. Separately, LifeCell contends that
the district court misconstrued “plasticized soft tissue
graft” and that, under the correct construction, LifeCell
does not infringe as a matter of law. Finally, it seeks
JMOL of invalidity on grounds that the asserted claims
are either anticipated by the Werner reference, U.S.
Patent No. 4,357,274, or rendered obvious over Werner
and the knowledge of a person of ordinary skill. In the
alternative, LifeCell seeks a new trial on infringement or
invalidity.
The district court’s ultimate claim construction is a
question of law reviewed de novo, with any subsidiary
factual findings regarding extrinsic evidence reviewed for
clear error. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.
Ct. 831, 841 (2015). We review a district court’s denial of
JMOL or a new trial under the law of the regional circuit.
Voda v. Cordis Corp., 536 F.3d 1311, 1318 (Fed. Cir.
LIFENET HEALTH v. LIFECELL CORP. 7
2008). Under the law of the Fourth Circuit, we review the
denial of JMOL de novo, “examin[ing] whether there is
substantial evidence in the record upon which the jury
could find for the prevailing party, viewing the evidence
in the light most favorable to that party.” Carolina
Trucks & Equip., Inc. v. Volvo Trucks of N. Am., Inc., 492
F.3d 484, 488 (4th Cir. 2007) (citation and internal quota-
tion marks omitted). Denial of a motion for a new trial is
reviewed in the Fourth Circuit for abuse of discretion
“and will not be reversed save in the most exceptional
circumstances.” Minter v. Wells Fargo Bank, N.A., 762
F.3d 339, 346 (4th Cir. 2014) (citation and internal quota-
tion marks omitted).
A
As noted above, the district court found that no fur-
ther construction was needed for the limitation “said one
or more plasticizers are not removed from [an] internal
matrix of [the] plasticized soft tissue graft prior to trans-
plantation.” See J.A. 65. LifeCell argues that the district
court’s failure to resolve a legal dispute regarding the
scope of that limitation constituted error under O2 Micro
International Ltd. v. Beyond Innovation Technology Co.,
521 F.3d 1351 (Fed. Cir. 2008). LifeNet responds that the
infringement dispute was properly presented to the jury
as a factual issue: whether the two-minute wash of the
accused products removes plasticizers from the internal
matrix as opposed to the gaps and voids of the tissue
graft.
In O2 Micro, we held that “[w]hen the parties raise an
actual dispute regarding the proper scope of . . . claims,
the court, not the jury, must resolve that dispute.” Id. at
1360. There is not necessarily an O2 Micro issue, howev-
er, whenever further claim construction could resolve the
parties’ dispute. For instance, “[t]he fact that shortly
before trial [a party] became dissatisfied with its own
proposed construction and sought a new one does not give
8 LIFENET HEALTH v. LIFECELL CORP.
rise to an O2 Micro violation.” Nuance Commc’ns, Inc. v.
ABBYY USA Software House, Inc., 813 F.3d 1368, 1373
(Fed. Cir. 2016). Here, in light of LifeCell’s failure to
sufficiently request further construction of the relevant
limitation leading up to and during trial, we find that it
fails to properly raise an O2 Micro issue.
According to LifeCell, the district court should have
instructed the jury that the asserted claims prohibit the
removal of any plasticizer from any part of the tissue
graft, i.e., whether that plasticizer is bound to the inter-
nal matrix or nonbound in the gaps and voids of the tissue
graft. As an initial matter, we observe that LifeCell’s
arguments relate not only to the degree of non-removal
required but also, more pertinently, from where those
plasticizers are not to be removed. Regarding the degree
of removal, the district court agreed with LifeCell at the
Markman stage to the extent the two-word phrase “‘not
removed’ means that no plasticizer is removed.” J.A. 66.
The court did not, however, go on to discuss the second
issue presented to us: from where those plasticizers are
not to be removed. Indeed, the parties did not dispute at
the Markman stage that the non-removal, as expressly
recited in the asserted claims, is directed to “the internal
matrix of the . . . tissue graft.” J.A. 1522.
For context, LifeNet’s infringement theory at trial was
that, while a two-minute wash of the accused products
removes plasticizers from the gaps and voids of the tissue
grafts, it does not remove plasticizer bound to the internal
matrix. In other words, LifeNet did not dispute the
degree of removal, as LifeCell contends, but looked to the
remainder of the limitation to argue that, in the accused
products, plasticizers are not removed “from [the] internal
matrix.” LifeCell now argues that this evidence does not
support an infringement finding because the internal
matrix and tissue graft are one and the same—removal of
plasticizer from the gaps and voids of the tissue graft also
constitutes removal from the internal matrix. See Open-
LIFENET HEALTH v. LIFECELL CORP. 9
ing Br. 12 (asserting that “the internal matrix is the
tissue graft”).
The problem with LifeCell’s argument is that it did
not timely request modification of the district court’s
claim construction. LifeCell asserts that it raised the
claim construction dispute with the district court, point-
ing us to a motion in limine, objections and arguments
made during trial, and a Rule 50(a) JMOL motion. How-
ever, in those instances, LifeCell merely sought to exclude
testimony contrary to the district court’s claim construc-
tion (which, to be clear, was “[n]o further construction
needed”) or to have the court instruct the jury as to the
degree of removal. LifeCell did not dispute that the
plasticizer could not be removed “from the internal matrix
of the soft tissue graft.” J.A. 7790. The district court
granted-in-part LifeCell’s motion in limine but expressly
allowed LifeNet to “offer testimony that the plasticizers
removed do not come from the internal matrix.” J.A.
7609. The court also overruled objections at trial on the
same evidentiary issue. In doing so, the district court
made clear, if it was not clear already, that it was not
construing the limitation at issue to bar removal of plasti-
cizer from the gaps and voids of the tissue graft.
Nevertheless, LifeCell did not request a new or modi-
fied claim construction. In its Rule 50(a) motion for
JMOL filed at the close of LifeNet’s infringement case,
LifeCell continued to present the issue as a factual one,
arguing that LifeNet offered testimony in violation of the
court’s in limine order and that there was insufficient
evidence to find infringement.
LifeCell’s objection to the district court’s jury instruc-
tions at the end of trial was also insufficient to raise the
O2 Micro issue that it presses on appeal. LifeCell merely
asked the court to replace “No further construction need-
ed” with a plain-meaning construction consistent with the
court’s prior statements: “Plain meaning, that no plasti-
10 LIFENET HEALTH v. LIFECELL CORP.
cizer is deliberately removed from the internal matrix of
the soft tissue graft prior to transplantation into a hu-
man.” J.A. 7689. Even if the district court had agreed to
that jury instruction, it would not have been the claim
construction that LifeCell now seeks on appeal. LifeCell
did not ask for clarification of what constitutes removal
“from the internal matrix.” In fact, the parties agreed to
the construction of “internal matrix,” as expressly defined
in the ’200 patent’s specification to mean “the intercellu-
lar substance of such soft tissue including for example
ligaments and tendons, including collagen and elastin
fibers and base matrix substances.” J.A. 1521; ’200 pa-
tent col. 6 ll. 59-65. LifeCell never asked the court to
adopt its argument that “internal matrix” is synonymous
with “tissue graft.”
In sum, LifeCell’s evidentiary challenges and request
for a claim construction did not adequately present the
refashioned claim construction argument that it now
raises on appeal. Lazare Kaplan Int’l, Inc. v. Photoscribe
Techs., Inc., 628 F.3d 1359, 1376 (Fed. Cir. 2010) (“[I]t
was incumbent upon [the appellant] to raise its claim
construction argument before the district court, and,
having failed to do so, [it] cannot now resurrect that
argument on appeal by pointing to ambiguous statements
in the record.”). LifeCell’s discontent with the agreed-
upon construction of “internal matrix” or with the district
court’s view of the longer phrase “said one or more plasti-
cizers are not removed from [an] internal matrix of [the]
plasticized soft tissue graft prior to implantation into a
human” is not sufficient to give rise to an O2 Micro viola-
tion. See Nuance, 813 F.3d at 1373 (finding no O2 Micro
issue when the district court adopted the appellant’s
proposed plain-meaning construction and the appellant
LIFENET HEALTH v. LIFECELL CORP. 11
became dissatisfied with that construction shortly before
trial). 1
As LifeNet submits, the parties presented a factual
dispute at trial as to whether a two-minute rinse removes
plasticizers from the internal matrix of the accused tissue
grafts. Although LifeCell does not expressly challenge the
sufficiency of the evidence on this issue, it points to pur-
ported inconsistencies in LifeNet’s evidence. For example,
LifeCell argues that LifeNet’s expert, Dr. Kaplan, contra-
dicted his own sworn statements and that LifeNet’s
witnesses provided “uniform trial testimony . . . that the
internal matrix is the graft.” Opening Br. 35-37. We
disagree with these characterizations of the evidence.
We do not accept LifeCell’s argument that Dr.
Kaplan’s trial testimony regarding the non-removal of
1 Even if we were to reach the construction of the
non-removal limitation, we see no error with the court’s
construction under the principles of Phillips v. AWH
Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). The
patentee added the non-removal limitation in response to
a rejection during prosecution and cited a passage from
the specification stating that the claimed invention could
be directly implanted into a patient without preparation.
That statement, however, was just one example of the
non-removal limitation (no rinse prior to transplantation)
and did not necessarily disclaim other embodiments
disclosed in the specification (e.g., a brief rinse or a one-
hour wash prior to implantation) that are consistent with
the specification’s teaching that plasticizer need not be
replaced by water prior to implantation. See TurboCare
Div. of Demag Delaval Turbomachinery Corp. v. Gen.
Elec. Co., 264 F.3d 1111, 1125 (Fed. Cir. 2001) (rejecting
argument that a claim amendment narrowed the claims
at issue because the added limitation was already “pre-
sent in the original claim”).
12 LIFENET HEALTH v. LIFECELL CORP.
plasticizers from the internal matrix of the accused prod-
ucts “deserves no weight” because it supposedly contra-
dicted his Markman declaration. See id. at 36. LifeCell
points to an excerpt of Dr. Kaplan’s declaration stating
that the ’200 patent discloses plasticizing in a new way
that “does not require rehydration, or even washing, to
remove the plasticizer(s) from the internal matrix of the
graft.” J.A. 1220. LifeCell interprets that testimony to
imply that removal of plasticizer is not difficult, con-
trasting it with Dr. Kaplan’s trial testimony that remov-
ing plasticizer from the internal matrix would be “very
difficult because it’s strongly bound into the surrounding
structures” and that a two-minute rinse would not remove
plasticizer from the internal matrix. J.A. 8196, 8234. We
see no inconsistency in Dr. Kaplan’s testimony. In the
declaration excerpt, he was speaking to an advantage of
the claimed invention over the prior art, not to the degree
of difficulty of removing plasticizer from the internal
matrix. Nor did Dr. Kaplan say at trial that plasticizer
can never be removed from the internal matrix, only that,
in the context of the technology at issue, such removal
would disrupt the matrix.
We also reject LifeCell’s assertion that LifeNet’s wit-
nesses agreed that an internal matrix is the same as a
tissue graft, such that the asserted claims prohibit re-
moval of plasticizer from anywhere in the tissue graft.
LifeCell points to the testimony of a LifeNet witness, Dr.
Qin, who said that “when we implant the tissue it’s basi-
cally just the matrix.” J.A. 7955. However, not only did
Dr. Qin qualify his testimony, but that testimony was also
in response to a question about revascularization, not
what “internal matrix” means relative to “tissue” in the
context of the ’200 patent. Dr. Kaplan, meanwhile, did
opine on “internal matrix” in the context of the ’200
patent and stated that it is composed of the components
left after a soft tissue graft has been cleaned. When
asked if anything other than the internal matrix would be
LIFENET HEALTH v. LIFECELL CORP. 13
“left behind,” he responded: “Yes. When you go through
this process, you are going to leave a huge number of
voids in the tissue, . . . and also you’ll have a great deal of
water left in the [t]issue.” J.A. 8188. On cross-
examination, he again differentiated the internal matrix
from the tissue graft, opining that the graft “includes [the]
internal matrix, . . . but there’s other [sic] plenty of loose
water, unbound water,” as well as “voids and other spaces
where you’ve decellularized.” J.A. 8274-75. As noted
above, the parties agreed to the construction of “internal
matrix,” which was drawn from an express definition in
the specification that did not refer to voids or gaps, and
Dr. Kaplan’s testimony was consistent with that construc-
tion.
Against this background, we find that there was sub-
stantial evidence to support the jury’s determination that
plasticizer is not removed “from the internal matrix” of
the accused tissue grafts before transplantation. The jury
was free to rely on Dr. Kaplan’s testimony and to find, as
a factual matter, that the accused products meet the
limitation at issue. The district court did not err in
denying JMOL or a new trial on non-infringement.
B
Based on the non-removal limitation and under the
law of divided infringement, LifeCell also argues that it
cannot be liable for direct infringement regardless of how
that limitation is construed. Direct infringement of an
apparatus claim “requires that each and every limitation
set forth in a claim appear in an accused product.” Cross
Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424
F.3d 1293, 1310 (Fed. Cir. 2005). Direct infringement of a
method claim requires all steps of the claimed method to
be performed by or attributable to a single entity. BMC
Res., Inc. v. Paymentech, L.P., 498 F.3d 1373, 1379-81
(Fed. Cir. 2007). Although we may attribute a third
party’s performance of method steps to a single entity in
14 LIFENET HEALTH v. LIFECELL CORP.
some circumstances, see Akamai Techs., Inc. v. Limelight
Networks, Inc., 797 F.3d 1020 (Fed. Cir. 2015) (en banc)
(per curiam), LifeNet did not pursue an attribution theory
at trial.
LifeCell posits that the non-removal limitation cannot
be met until an independent third party, such as a sur-
geon, actually prepares and uses the accused products,
and it is unknown at the time that LifeCell sells a graft if
and how that graft will be used for transplantation. 2
LifeNet counters that “the final product that leaves
LifeCell’s hands is complete and . . . infringes in that
condition” without affirmative action by a third party.
Response Br. 44. We agree with LifeNet.
Functional limitations recited in the negative may de-
scribe a capability or structural element. See Amgen Inc.
v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1329 (Fed.
Cir. 2003) (holding that “non-naturally occurring” and
“not isolated” were structural elements defining the
source of the claimed material, rather than steps for
obtaining it). Here, the preceding language in each
asserted claim states that the relevant plasticizers are
already part of the tissue graft. See, e.g., ’200 patent col.
24 l. 12 (“plasticizers contained in [the] internal matrix”);
id. at col. 24 ll. 41-42 (“impregnating a cleaned, soft tissue
graft with one or more plasticizers”). The non-removal
limitation simply provides a negative limitation that
those plasticizers remain in the internal matrix prior to
transplantation.
LifeCell relies on Cross Medical Products, Inc. v. Med-
tronic Sofamor Danek, Inc., 424 F.3d 1293 (Fed. Cir.
2005), and Centillion Data Systems, LLC v. Qwest Com-
2 LifeCell does not argue that the apparatus and
method claims should be treated differently in our divided
infringement analysis.
LIFENET HEALTH v. LIFECELL CORP. 15
munications International, Inc., 631 F.3d 1279 (Fed. Cir.
2011), to argue that there can be no direct infringement
by a single entity when a limitation is absent until a third
party takes action. However, those cases are distinguish-
able. In Cross Medical, we held that surgical implants
with an interface that had to be “operatively joined” to a
segment of bone could not be directly infringed by the
manufacturer insofar as that party “d[id] not itself make
an apparatus” with the relevant portion already in con-
tact with bone. 424 F.3d at 1311. Rather, a third party
surgeon had to “actually bring the [relevant part] into
contact with bone.” Id. at 1310. Similarly, in Centillion,
we held that the accused infringer, who provided software
to customers, did not itself practice a limitation requiring
a “personal computer data processing means” because “it
is entirely the decision of the customer whether to install
and operate th[e] software on its personal computer data
processing means.” 631 F.3d at 1287. The claimed inven-
tions in Cross Medical and Centillion affirmatively re-
quired action by a third party, without which a limitation
would be absent. Here, in contrast, the non-removal
limitation clarifies that the recited plasticizer has not
been removed and, because the plasticizer is biocompati-
ble, can remain in the internal matrix of the tissue graft
during transplantation, i.e., it need not ever be removed.
This limitation is met without action by a third party. It
is satisfied by the graft from the moment it is manufac-
tured unless and until the plasticizer is removed from the
internal matrix before transplantation.
Therefore, the non-removal limitation does not relieve
LifeCell of direct infringement.
C
LifeCell also contends that because the non-removal
limitation describes a method of use while the remainder
of claims 1-4 describes an apparatus, those claims are
indefinite for covering both an apparatus and a method of
16 LIFENET HEALTH v. LIFECELL CORP.
using that apparatus. The ultimate determination of
indefiniteness is a question of law reviewed de novo,
“although, as with claim construction, any factual find-
ings by the district court based on extrinsic evidence are
reviewed for clear error.” UltimatePointer, LLC v. Nin-
tendo Co., 816 F.3d 816, 826 (Fed. Cir. 2016).
LifeCell relies on IPXL Holdings, LLC v. Amazon.com,
Inc., 430 F.3d 1377 (Fed. Cir. 2005), in which we held a
claim invalid for indefiniteness when “as a result of the
combination of two separate statutory classes of inven-
tion, a manufacturer or seller of the claimed apparatus
would not know from the claim whether it might also be
liable for contributory infringement because a buyer or
user of the apparatus later performs the claimed method
of using the apparatus.” Id. at 1384. As explained above,
however, the non-removal limitation defines a property of
the recited plasticizer in that the plasticizer is biocompat-
ible and does not need to be removed from the internal
matrix before transplantation in the context of apparatus
claims 1-4, so no later action by a user of the tissue graft
is necessary. Those claims therefore do not mix an appa-
ratus with a method of using that apparatus, and the
district court did not err in denying JMOL as to indefi-
niteness.
D
LifeCell separately argues that the district court erred
in its construction of “plasticized soft tissue graft.” The
district court construed this limitation to require, inter
alia, that “free and loosely bound waters of hydration in
the tissue have been replaced with one or more plasticiz-
ers.” J.A. 63 (emphasis added).
LifeCell contends that the district court mistakenly
failed to also require that the tissue graft be “dehydrat-
ed,” in the sense that the tissue can only have “low resid-
ual moisture.” Opening Br. 43-44. Under that
construction, LifeCell contends there can be no infringe-
LIFENET HEALTH v. LIFECELL CORP. 17
ment as a matter of law because the accused products
have at least 60% moisture. LifeNet responds that “dehy-
dration,” as that word is used in the ’200 patent, merely
means that some of the water has been replaced with
plasticizer and that the district court’s construction
already includes that understanding.
We agree with LifeNet. Although LifeCell is correct
that the written description repeatedly uses the word
“dehydrated,” it does so broadly. For example, the specifi-
cation discusses “soft tissue which is preserved by dehy-
dration, such drying methods including for example,
freeze-drying, and/or sublimation and/or air drying
and/or liquid substitution.” ’200 patent col. 6 ll. 35-39
(emphasis added). Although the specification states that
“[t]he present invention provides a dehydrated or freeze-
dried plasticized bone or soft tissue product, preferably
containing less than 5% residual moisture,” id. at col. 5 ll.
29-31, we decline to confine the claims to such an embod-
iment where, as in this context, there is no indication that
the “patentee . . . intend[ed] for the claims and the embod-
iments in the specification to be strictly coextensive,”
Phillips, 415 F.3d at 1323. There is no support for the
proposition that the claimed soft tissue graft must be
dehydrated to a certain degree or completely desiccated.
The addition of the word “dehydrated” to the claim con-
struction would be redundant of the requirement for
plasticizer to replace some water, which is already proper-
ly part of the district court’s construction.
We decline to adopt LifeCell’s proposed construction of
“plasticized soft tissue graft,” and LifeCell does not oth-
erwise argue that the jury’s infringement verdict lacks
substantial evidence. Therefore, we do not disturb the
court’s denial of JMOL of non-infringement or a new trial
on this ground.
18 LIFENET HEALTH v. LIFECELL CORP.
E
Finally, we address LifeCell’s argument that the as-
serted claims are either anticipated by Werner or obvious
in view of Werner and the knowledge of a person of ordi-
nary skill. Anticipation is a question of fact reviewed for
substantial evidence. DDR Holdings, LLC v. Hotels.com,
L.P., 773 F.3d 1245, 1252 (Fed. Cir. 2014). Obviousness is
a question of law reviewed de novo, with underlying
factual findings, such as whether a reference discloses a
limitation, reviewed for substantial evidence. Muniauc-
tion, Inc. v. Thomson Corp., 532 F.3d 1318, 1324 (Fed.
Cir. 2008).
Werner is a patent that discloses a process for treat-
ing a soft tissue with hydrogen peroxide and other steps
to increase biological stability. At trial, LifeNet disputed
whether Werner meets two limitations of the asserted
claims: “cleaned” and “plasticized soft tissue graft.”
LifeCell argues on appeal that “[t]he evidence allows only
one reasonable conclusion”—that Werner discloses both
limitations and therefore anticipates the asserted claims.
Opening Br. 57. Alternatively, it argues that Werner “at
most . . . would lack a sufficient degree of ‘cleaning’ the
tissue, which would have been an obvious modification to
a person skill in the art at the time of the invention.” Id.
With respect to a “plasticized soft tissue graft,” the
district court construed that limitation to specifically
require, inter alia, that plasticization occur “without
altering the orientation of the collagen fibers, such that
the mechanical properties, including the material, physi-
cal and use properties, of the tissue product are similar to
those of normal hydrated tissue.” J.A. 69 (emphases
added). LifeCell does not direct us to any evidence from
its affirmative case to support its burden of showing that
Werner discloses a “plasticized soft tissue graft.” See
Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d
1346, 1353 (Fed. Cir. 2013) (“[T]he burden of persuasion
LIFENET HEALTH v. LIFECELL CORP. 19
[as to invalidity] remains with the challenger during
litigation.”). Aside from arguing for a different construc-
tion of “plasticized soft tissue graft,” which we have
rejected, LifeCell focuses on trying to undermine Dr.
Kaplan’s testimony that Werner’s process renders the
mechanical properties of tissue different from native
tissue.
A review of the record shows that there is substantial
evidence to support a jury finding that Werner does not
disclose a plasticized soft tissue graft under the district
court’s construction. Dr. Kaplan explained that, unlike
the ’200 patent, in Werner, “the mechanical properties are
altered significantly from native tissue,” namely by “in-
creas[ing] . . . tensile strength by a factor of 1.7 to 7.0.”
J.A. 9262-63; see also J.A. 9279 (explaining that Werner
does not retain the “mechanical properties of the native-
like tissue”). Although Dr. Kaplan conceded on cross-
examination that the data was not statistically different,
he maintained that the difference in mechanical proper-
ties between Werner’s tissue and native tissue was still a
basis for finding those properties not similar enough to
meet the court’s construction of “plasticized soft tissue
graft.” LifeCell’s expert, Dr. Stephen Badylak, testified
that he could not say whether or not the tensile strength
difference that Dr. Kaplan relied on was “similar” under
the court’s construction. J.A. 9099. However, he agreed
on cross-examination that “the mechanical properties,
including the physical and use properties” of Werner
“have changed” and stated that he was “starting to think
[the change in tensile strength] is different.” J.A. 9097-
99.
The ultimate issue on this record was a classic factual
dispute that the jury was free to resolve in LifeNet’s
favor. See, e.g., Kinetic Concepts, Inc. v. Smith & Nephew,
Inc., 688 F.3d 1342, 1361 (Fed. Cir. 2012) (“[S]ubstantial
evidence supports the jury’s implied factual finding that
none of these references disclosed the [limitation at is-
20 LIFENET HEALTH v. LIFECELL CORP.
sue].”). Since there is substantial evidence to support a
finding that Werner fails to disclose “plasticized soft
tissue graft,” we need not reach the “cleaned” limitation.
The district court did not err in denying LifeCell’s request
for JMOL or a new trial with respect to anticipation.
LifeCell only argues obviousness on appeal with re-
spect to the “cleaned” limitation. It does not point to any
evidence that a “plasticized soft tissue graft,” if not dis-
closed by Werner, would have been an obvious modifica-
tion to a person of ordinary skill in the art. As LifeCell
fails to provide a basis for disclosure of a “plasticized soft
tissue graft” outside of Werner, the district court also did
not err in denying JMOL or a new trial on obviousness.
CONCLUSION
For the foregoing reasons, we affirm the district
court’s judgment.
AFFIRMED