Lifenet Health v. LifeCell Corp.

• Decision Date: 16 September 2016
• Docket Number: 2015–1549
• Citation: 837 F.3d 1316,120 U.S.P.Q.2d 1001
• Parties: LifeNet Health, Plaintiff–Appellee v. LifeCell Corporation, Defendant–Appellant
• Court: U.S. Court of Appeals — Federal Circuit

837 F.3d 1316

120 U.S.P.Q.2d 1001

LifeNet Health, Plaintiff–Appellee

v.LifeCell Corporation, Defendant–Appellant

2015–1549

United States Court of Appeals, Federal Circuit.

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.

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 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.

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 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.

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).

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 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.

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 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 ., ––– U.S. ––––, 135 S.Ct. 831, 841, ––– L.Ed.2d –––– (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. 2008). Under...