Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01549/USCOURTS-ca13-15-01549-0/pdf.json

Parties Involved:
LifeCell Corporation
Appellant
LifeNet Health
Appellee

Document Text:

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-HCMDEM, Senior Judge Henry C. Morgan Jr.

______________________ 

Decided: September 16, 2016

______________________ 

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.

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. 

Case: 15-1549 Document: 71-2 Page: 1 Filed: 09/16/2016
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 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. 

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 freezedrying, 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. 

The ’200 patent’s “plasticized” tissue grafts avoid 

these problems. The tissue is preserved not by freezedrying but by replacing the tissue’s water with biocompatCase: 15-1549 Document: 71-2 Page: 2 Filed: 09/16/2016
LIFENET HEALTH v. LIFECELL CORP. 3

ible 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. 

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 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. 

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] 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). 

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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 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). 

LifeCell’s 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. 

During claim construction proceedings, the parties 

disputed the meaning of several terms, including the nonremoval 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, 

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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 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 twoword 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. 

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” plasticizer 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 

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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] internal 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, independent 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.

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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 quotation 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 quotation marks omitted).

A 

As noted above, the district court found that no further 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 transplantation.” 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, however, 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 

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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 internal 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 OpenCase: 15-1549 Document: 71-2 Page: 8 Filed: 09/16/2016
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, pointing us to a motion in limine, objections and arguments 

made during trial, and a Rule 50(a) JMOL motion. However, in those instances, LifeCell merely sought to exclude

testimony contrary to the district court’s claim construction (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 plasticizer from the gaps and voids of the tissue graft. 

Nevertheless, LifeCell did not request a new or modified 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 instructions 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 needed” with a plain-meaning construction consistent with the 

court’s prior statements: “Plain meaning, that no plastiCase: 15-1549 Document: 71-2 Page: 9 Filed: 09/16/2016
10 LIFENET HEALTH v. LIFECELL CORP. 

cizer is deliberately removed from the internal matrix of 

the soft tissue graft prior to transplantation into a human.” 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 intercellular substance of such soft tissue including for example 

ligaments and tendons, including collagen and elastin 

fibers and base matrix substances.” J.A. 1521; ’200 patent 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 agreedupon construction of “internal matrix” or with the district 

court’s view of the longer phrase “said one or more plasticizers 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 violation. 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 

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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 purported inconsistencies in LifeNet’s evidence. For example,

LifeCell argues that LifeNet’s expert, Dr. Kaplan, contradicted 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 onehour 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 “present in the original claim”).

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12 LIFENET HEALTH v. LIFECELL CORP. 

plasticizers from the internal matrix of the accused products “deserves no weight” because it supposedly contradicted 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, contrasting it with Dr. Kaplan’s trial testimony that removing 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 witnesses agreed that an internal matrix is the same as a

tissue graft, such that the asserted claims prohibit removal 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 basically 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 

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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 crossexamination, 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 construction.

Against this background, we find that there was substantial 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 

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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 surgeon, 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 describe 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. Medtronic 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. 

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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 distinguishable. 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 contact 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 inventions in Cross Medical and Centillion affirmatively required 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 biocompatible, 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 manufactured 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 

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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 findings by the district court based on extrinsic evidence are 

reviewed for clear error.” UltimatePointer, LLC v. Nintendo 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 invention, 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 biocompatible 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 apparatus with a method of using that apparatus, and the 

district court did not err in denying JMOL as to indefiniteness.

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 plasticizers.” J.A. 63 (emphasis added).

LifeCell contends that the district court mistakenly 

failed to also require that the tissue graft be “dehydrated,” in the sense that the tissue can only have “low residual moisture.” Opening Br. 43-44. Under that 

construction, LifeCell contends there can be no infringeCase: 15-1549 Document: 71-2 Page: 16 Filed: 09/16/2016
LIFENET HEALTH v. LIFECELL CORP. 17

ment as a matter of law because the accused products 

have at least 60% moisture. LifeNet responds that “dehydration,” 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 specification discusses “soft tissue which is preserved by dehydration, 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 freezedried 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 embodiment where, as in this context, there is no indication that 

the “patentee . . . intend[ed] for the claims and the embodiments 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 construction would be redundant of the requirement for 

plasticizer to replace some water, which is already properly part of the district court’s construction. 

We decline to adopt LifeCell’s proposed construction of 

“plasticized soft tissue graft,” and LifeCell does not otherwise 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.

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18 LIFENET HEALTH v. LIFECELL CORP. 

E 

Finally, we address LifeCell’s argument that the asserted claims are either anticipated by Werner or obvious

in view of Werner and the knowledge of a person of ordinary 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. Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1324 (Fed. 

Cir. 2008).

Werner is a patent that discloses a process for treating 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, physical 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 

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LIFENET HEALTH v. LIFECELL CORP. 19

[as to invalidity] remains with the challenger during 

litigation.”). Aside from arguing for a different construction 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 “increas[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 nativelike tissue”). Although Dr. Kaplan conceded on crossexamination that the data was not statistically different, 

he maintained that the difference in mechanical properties 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 isCase: 15-1549 Document: 71-2 Page: 19 Filed: 09/16/2016
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 respect to the “cleaned” limitation. It does not point to any 

evidence that a “plasticized soft tissue graft,” if not disclosed by Werner, would have been an obvious modification 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

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