Kinetic Concepts, Inc. v. Smith & Nephew, Inc.

• Citation: 688 F.3d 1342,104 U.S.P.Q.2d 1001
• Decision Date: 13 August 2012
• Docket Number: No. 2011–1105.,2011–1105.
• Parties: KINETIC CONCEPTS, INC., KCI Licensing, Inc., KCI USA, Inc., KCI Medical Resources, KCI Manufacturing, and Medical Holdings Limited, Plaintiffs, and Wake Forest University Health Sciences, Plaintiff–Appellant, v. SMITH & NEPHEW, INC., Defendant–Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

688 F.3d 1342

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

KINETIC CONCEPTS, INC., KCI Licensing, Inc., KCI USA, Inc., KCI Medical Resources, KCI Manufacturing, and Medical Holdings Limited, Plaintiffs,

and

Wake Forest University Health Sciences, Plaintiff–Appellant,

v.SMITH & NEPHEW, INC., Defendant–Appellee.

No. 2011–1105.

United States Court of Appeals,Federal Circuit.

Aug. 13, 2012.

Matthew D. Powers, Weil, Gotshal & Manges LLP, of Redwood Shores, CA, argued for plaintiff-appellant. With him on the brief were Elizabeth Stotland Weiswasser, Peter Sandel, Jennifer H. Wu, Danielle Rosenthal and Erin Wiggins, of New York, NY. Of counsel was Andrew Swanson Brown.

Joseph R. Re, Knobbe, Martens, Olson & Bear, LLP, of Irvine, CA, argued for defendant-appellee. With him on the brief were James F. Lesniak, Shelia N. Swaroop and Christy G. Lea. Of counsel on the brief was Mark J. Gorman, Smith & Nephew, Inc., of Cordova, TN.

Before BRYSON, DYK and O'MALLEY, Circuit Judges.

Opinion for the court filed by Circuit Judge O'MALLEY. Circuit Judge DYK concurs in the result.

O'MALLEY, Circuit Judge.

Wake Forest University Health Sciences (“Wake Forest”) appeals the district court's grant of judgment as a matter of law (“JMOL”) of invalidity for obviousness. In granting Smith & Nephew, Inc.'s (“S & N”) motion for JMOL, the district court overturned the jury's determination that S & N had failed to prove that the asserted claims of the patents in suit were obvious. We conclude that, on the basis of the jury's factual findings, S & N failed to establish by clear and convincing evidence that the claims were obvious. Accordingly, we reverse and remand.¹

Background

I. Asserted Patents

Kinetic Concepts, Inc., KCI Licensing, Inc., KCI USA, Inc., KCI Medical Resources, KCI Manufacturing, and Medical Holdings Limited (collectively “KCI”) and Wake Forest brought suit against S & N, alleging infringement of U.S. Patent Nos. 7,216,651 (“'651 patent”) and 5,645,081 (“'081 patent”). Wake Forest is the owner of the asserted patents, and KCI are the exclusive licensees of the patents. Both patents claim methods and apparatuses for treating difficult-to-heal wounds by applying suction or negative pressure, e.g., '651 patent Abstract; '081 patent Abstract. Wake Forest and KCI asserted that S & N infringes apparatus claims 2 and 5 of the '081 patent and induces infringement of method claims 42, 109, 116, and 121 of the '651 patent.

As described by the asserted patents, medical “treatment of open wounds that are too large to spontaneously close” is difficult. '081 patent col.1 ll.11–12; '651 patent col.1 ll.29–30. “Wound closure requires that epithelial and subcutaneous tissue migrate from the wound border toward the wound.” '081 patent col.2 ll.49–50. To facilitate such migration, doctors commonly use mechanical closures, such as sutures or staples. Id. at col.l 11.24–25. Such mechanical closures create tension on the skin, which encourages epithelial migration. Id. at col.l 11.25–28. “While suturing and stapling of wounds is widely practiced, it has a major drawback: the tensile force required to achieve closure with sutures or staples causes very high localized stresses at the suture insertion points, resulting in the rupture of the tissue at these points.” Id. at col.l 11.28–33. This rupturing inhibits healing of the wound. Id. at col.l 11.33–35. Additionally, it is not feasible to suture some large open wounds. Id. at col.1 ll.28–33.

To address these shortcomings, the invention applies “negative pressure to a wound over an area sufficient to promote migration of epithelial and subcutaneous tissue toward the wound, with the negative pressure being maintained for a time sufficient to facilitate closure of the wound.” Id. at col.2 ll.45–49; '651 patent col.4 ll.18–23 (“[A] method of treating tissue damage is provided which comprises applying a negative or reduced pressure to a wound over an area sufficient to promote the migration of epithelial and subcutaneous tissue toward the wound and for a time period sufficient to facilitate closure of the wound.”). Claim 2 of the '081 patent and claim 42 of the '651 patent are illustrative:

2. An apparatus for facilitating the healing of wounds, comprising:

vacuum means for creating a negative pressure between about 0.1 and 0.99 atmospheres on the area of skin including and surrounding the wound;

sealing means operatively associated with said vacuum means for maintaining said negative pressure on said wound by contacting the skin surrounding said wound; and

open-cell polymer for positioning at the wound within the sealing means for preventing the over-growth of tissue in the wound.

'081 patent col.9 ll.50–65.

42. A method of treating a wound comprising the steps of:

i. providing a vacuum source capable of providing at least 0.11 atm of reduced pressure;

ii. locating a flexible adhesive cover over the wound, said cover having a suction port;

iii. locating a porous material comprising a synthetic polymer under said cover at the wound;

iv. adhesively sealing and adhering the periphery of said cover to tissue surrounding the wound to form a continuous seal;

v. operably connecting said suction port with said vacuum system for producing said reduced pressure;

vi. interposing a fluid trap between said suction port and said vacuum source; and vii. maintaining reduced pressure of at least 0.11 atm at the wound until the wound had progressed toward a selected stage of healing.

'651 patent col.25 ll.31–48.

Figure 1 of the '651 patent discloses the key components of the claimed apparatus:

Image 1 (4.44" X 3.95") Available for Offline Print As depicted in this figure, the claimed apparatus includes: (1) a vacuum pump (30); (2) tubing (12); (3) an open-celled foam wound screen (10); and (4) an adhesive seal (18). '651 patent col.6 ll.31–61; see also '081 patent col.2 ll.30–35 (“FIG. 1 shows a cross-sectional view of a negative pressure device comprising a open-cell polymer screen, a flexible hose connecting the foam section to a suction pump, and a flexible polymer sheet overlying the foam-hose assembly to provide the necessary seal.”). To utilize the apparatus, “[f]irst, the open cell foam is cut to fit the shape of the wound and placed inside the wound. Then the adhesive seal is placed over the foam that is inside the wound.” Kinetic Concepts, Inc. v. Blue Sky Med. Grp., Inc., No. 08–cv–102, slip op. at 2 (W.D.Tex. Oct. 10, 2010) (order granting defendant's motion for judgment as a matter of law of invalidity for obviousness) (ECF No. 605) (“ JMOL Order ”). Once the seal is in place, “[o]ne end of the tubing is placed through the seal into the foam and the other end is attached to the vacuum pump. The vacuum pump is turned on and, because of the tight seal around the wound, the edges of the wound immediately begin to move together.” Id.

II. Prior Art

In the present litigation, S & N asserted prior art that generally falls into three primary categories: (1) the Bagautdinov references; (2) the Zamierowski reference; and (3) the Chariker–Jeter references. On appeal, there is no dispute that these references are all prior art.

A. Bagautdinov References

The Bagautdinov references consist of two articles written by Dr. Bagautdinov. The first reference (“Bagautdinov I”) was published in 1986. Joint Appendix (“J.A.”) 10001–03. It discusses “a method for vacuum treatment of primary and secondary purulent wounds.” J.A. 10002. The reference describes the method as follows:

After surgical treatment of the purulent wound and hemostasis, a drain of polyurethane foam adapted in shape and size is placed on the surface (or in the cavity). The surrounding skin is smeared with sterile vaseline, antiseptic or inert salve on an oil base and covered with a polyethylene film.... Regardless of the method of sealing, a tube is hermetically installed onto the foam through a hole in the polyethylene made beforehand. The latter is connected to the vacuum pump through a collection vessel. At a vacuum of 10 to 60 mmHg the film clenches the wound strictly along its skin boundaries with uniform vacuum treatment of the walls only on the side of the cavity and elimination of exudate because of the porous structure of the drain. The duration of the treatment sessions depends on the degree of vacuum and ranges from 30 minutes to 2 hours, whereupon the polyethylene is removed and a gauze bandage emplaced. The sessions are conducted daily until the wound is clean. On average this procedure takes 3 to 4 days.

Id. Bagautdinov I notes that use of this method “inevitably obtain[s] acceleration of the healing periods and rehabilitation of the patients.” J.A. 10003. The second reference (“Bagautdinov II”) was also published in 1986. J.A. 10026–27. Bagautdinov II describes application of a method similar to that described in Bagautdinov I to 170 patients. J.A. 10026. The method employed requires that,

[i]mmediately after surgical treatment of the infected area in the commonly accepted manner or using a Scalpel–1 laser, a drain made from polyurethane foam is placed in the wound. For sorption treatment, it is first filled with activated charcoal powder. The wound is sealed with polyethylene film in one of several ways, depending on the localization of the purulent focus. Vacuum aspiration is conducted through an aspiration tube using a constant suction pump. Thus, the polyethylene film “clenches” the wound strictly along its edges, and the sorbent makes secure contact with the walls. The porous structure of the drain allows for removal of exudate and vacuumization of the wound only from the cavity side. The session lasts 1–2 hours with negative pressure of 10–40 mmHg, after which the isolation is removed. The drain is changed 1–2 times daily. Vacuum treatment was continued for 3–4 days.

J.A. 10026–27. As a result of this method, “[o]n average, the wound became clean by day 4–5, with the appearance of granulated tissue.... The average duration of inpatient treatment was 11.8...