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Regents of University of Minnesota v. AGA Medical Corp.

United States Court of Appeals, Federal Circuit

June 3, 2013

REGENTS OF THE UNIVERSITY OF MINNESOTA, Plaintiff-Appellant,
v.
AGA MEDICAL CORPORATION, Defendant-Appellee.

Appeal from the United States District Court for the District of Minnesota in No. 07-CV-4732, Judge Patrick J. Schiltz.

Kevin D. Conneely, Leonard, Street and Deinard Professional Association, of Minneapolis, Minnesota, argued for the plaintiff-appellant. With him on the brief were David D. Axtell, Ruth A. Rivard and Katherine A. Moerke.

J. Derek Vandenburgh, Carlson, Caspers, Vanden-burgh, Lindquist & Schuman, P.A., of Minneapolis, Minnesota, argued for defendant-appellee. With him on the brief were Alan G. Carlson, R.J. Zayed, and Tara C. Norgard.

Before Rader, Chief Judge, and Dyk and Wallach, Circuit Judges.

Dyk, Circuit Judge.

Appellant Regents of the University of Minnesota ("the University") owns U.S. Patent No. 6, 077, 281 ("the '281 patent") and U.S. Patent No. 6, 077, 291 ("the '291 patent"), which are directed to medical devices for repairing heart defects. The University accused AGA Medical Corporation ("AGA") of infringing both patents. After claim construction, the district court granted summary judgment that the '291 patent was not infringed and that the asserted claims of the '281 patent were invalid as anticipated. The University appeals, arguing that the district court erred in its construction of the claims of the '291 patent, and in finding the '281 patent anticipated by a prior art device. We affirm.

Background

The '291 and '281 patents are directed toward "septal occluders, " which are medical devices used to block holes in a thin wall of muscle and tissue (a "septum") dividing two chambers of the heart. "Transcatheter" septal occluders can be delivered to the heart and positioned in a septal defect using a catheter threaded through a vein. In 1975, King and Mills received a patent on the first transcatheter septal occluder ("the King device"). U.S. Pat. No. 3, 874, 388 (filed Feb. 12, 1973).

In 1992, the University filed Patent Application No. 07/822, 951 ("the '951 application") claiming a transcatheter septal occluder invented by Dr. Gladwin Das. Four patents eventually issued from successive divisions of the '951 application, including U.S. Patent No. 5, 334, 217 ("the '217 patent"), issued in April 1994, another patent not at issue here, and the '291 and '281 patents, which were both issued in June 2000. The patents have different claims, but generally share the same specification. The "Summary of the Invention" explains that the claimed device has "first and second occluding disks which are attached to one another" centrally. '291 patent col. 3 ll. 7–8; '281 patent col. 3 ll. 11–12. Each disk comprises a membrane and a frame, and can be "collapsed" to fit in a catheter. '291 patent col. 3 ll. 8–12. The device is delivered through the catheter to the heart, where it is positioned with one disk on each side of the defective septum. As the catheter is withdrawn, the disks expand, covering both sides of the defective septum and blocking the hole. See id. at col. 3 ll. 10–14. The patents' shared specification acknowledges prior art septal occluders with expandable membranes, including the patented King device and a device described in an article by Dr. James Lock ("the Lock device"). The Lock and King devices both have "umbrella-like" structures mounted on radial frames. The specification of the patents-in-suit disparages prior art radial frame devices as "mechanically complex and requir[ing] a great deal of remote manipulation for deployment, " '291 patent col. 2 ll. 44–45; '281 patent col. 2 ll. 48–49, and because the "single point or pivot" connecting the two umbrella structures can drift within the septal defect, allowing the device to become decentered. '291 patent col. 2 ll. 52–56; '281 patent col. 2 ll. 56–60.

In 2007, the University filed suit against AGA, alleging infringement of the '291 and '281 patents. AGA's accused septal occluders are one-piece devices made from tubes of wire mesh. The mesh is molded into a preset shape with two large flat regions separated by a narrow waist. The device can be compressed into an elongated shape to fit in a catheter. Upon deployment from the catheter inside the heart, the device spontaneously springs back to the preset shape and blocks the septal defect.

At the parties' request, the district court held a Markman hearing and construed various disputed terms in the '291 and '281 patents. See Regents of the Univ. of Minn. v. AGA Med. Corp., 660 F.Supp.2d 1037 (D. Minn. 2009). In January 2011, the court partially granted AGA's motion for summary judgment of non-infringement, ruling that no reasonable jury could find that AGA's one-piece mesh device infringed the '291 patent. Regents of the Univ. of Minn. v. AGA Med. Corp., No. 07-CV-4732, 2011 WL 13943, at *9, *15–16 (D. Minn. Jan. 4, 2011). In December 2011, the court granted AGA's motion for summary judgment of invalidity with respect to asserted claims 1, 4, and 5 of the '281 patent, Regents of the Univ. of Minn. v. AGA Med. Corp., 835 F.Supp.2d 711 (D. Minn. 2011), finding that all three claims were anticipated by the prior art Lock device, id. at 723–26.[1]The district court dismissed AGA's remaining counterclaims as moot. Id. at 713–14.[2] The University timely appealed, and we have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). Although the patents in this case are related, they present distinct legal issues on appeal, so we discuss them separately.

Discussion

I. The '291 Patent

A. Claim construction

The dispute as to the '291 patent turns almost entirely on claim construction. Claim construction is a question of law, Markman v. Westview Instruments, Inc., 52 F.3d 967, 976–80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996), which we review without deference, Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454–55 (Fed. Cir. 1998) (en banc).

Representative claim 1 of the '291 patent describes a septal occluder with two occluding disks "affixed" to one another at their centers, to "define a conjoint disk":

1. A septal defect closure device comprising first and second occluding disks, each disk comprising a flexible, biologically compatible membrane capable of being collapsed for passage through a catheter and elastically returning to a predetermined shape for tautly holding a portion of the membrane against a septum; a central portion of the membrane of the first disk being affixed to a central portion of the membrane of the second disk to define a conjoint disk . . . .

'291 patent col. 17 ll. 54–61 (emphases added).

As shown in Figures 3 and 4, a preferred embodiment of the claimed invention comprises two membrane disks (20, 30), each having a jointed pentagonal frame (24) "attached to and desirably extend[ing] substantially around the periphery of the membrane." '291 patent col. 5 ll. 5–6. The flexible frames can be compressed to allow the device to pass through a catheter for delivery to the heart. As the catheter is withdrawn and the device is released, the frames expand to pull the membrane disks taut. Figure 3 depicts a side view of the device with the two membrane disks fully expanded (22, 32) and the smaller "conjoint disk" (40) between them:

(IMAGE OMITTED)

'291 patent figs. 3, 4. Figure 4 illustrates how, in this preferred embodiment, the two membrane disks are "sewn to one another . . . with the stitching defining the shape and size of the conjoint disk" (40). '291 patent col. 7 11. 55-57. An appropriately sized conjoint disk is positioned inside the septal defect, while the expanded frames (which are larger than the defect) rest against either side of the septum to hold the device in place.

With respect to the '291 patent, one issue of claim construction is disputed on appeal: whether the district court correctly construed the patent to require two discrete disks. All independent claims of the '291 patent relate to a device with "first and second disks" or "first and second occluding disks." Regents, 660 F.Supp.2d at 1042. The two disks are described as "affixed" (claims 1, 4, 23, 24, 30), "joined" (claims 17, 24, 25), or "connected" (claim 28) to one another, forming a "conjoint" structure (claims 1–5, 9, 11, 12, 14, 15, 23, 25–27). As the district court noted, "[t]he parties . . . agreed to treat the terms 'affixed, ' 'joined, ' and 'connected' as essentially synonymous." Id. at 1041. Nor does either party dispute that throughout the '291 patent, the term "conjoint" is used to denote the affixed, joined, or connected portions of the disks. The district court concluded that "a person of ordinary skill in the art . . . would read the '291 patent as covering only a device made up of two physically separate disks that are attached to one another, " and therefore construed the phrase "first and second [occluding] disks" to mean "physically distinct and separate disks." Id. at 1045. The court reasoned that "one does not ordinarily speak of the parts of a unitary structure as being 'affixed' or 'joined' or 'connected' to each other, " id. at 1044, and concluded that this "clear implication . . . should be made explicit" in its claim construction by requiring that the disks had been originally separate, id. at 1043. The court "reached this decision in part based on how the phrase 'conjoint disk' is used throughout the patent, " that is, to describe a structure formed by affixing, joining, or connecting the two disks. Id. at 1044; see also id. at 1056. A subsequent order elaborated that "[t]he word 'disks' in the phrases 'first and second occluding disks' and 'first and second disks' means 'disks that, before being affixed, joined, or connected, exist separately as individual, physically distinct disks.'" Regents, 2011 WL 13943, at *2. It is undisputed that this construction excludes AGA's device, which is molded from a single tubular piece of mesh.

On appeal, the University argues that the district court's construction improperly imported limitations from outside the claims, and is unsupported by the specification or prosecution history. We disagree.

The claim language fully supports a requirement of separateness. Independent claim 1 explains that the "conjoint disk" is formed by "affix[ing]" the membranes of the "first and second occluding disks" to one another. '291 patent col. 17 ll. 54–64. Dependent method claim 23 describes the occluder as having "a central portion of the flexible structure of the first disk being affixed directly to a central portion of the flexible structure of the second disk to define [a] conjoint disk." Id. at col. 19 ll. 16–19. Both dependent claims 11 and 12 describe a "conjoint disk" "compris[ing] a piece of another material disposed between the first and second disks, " further supporting the conclusion that the two disks must be discrete structures.[3] Id. at col. 18 ll. 23–29.

The separateness requirement is also fully supported by the specification, which is "the single best guide to the meaning of a disputed term." Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) (quoting Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). The '291 specification never teaches an embodiment constructed as a single piece. Quite the opposite: "every single embodiment disclosed in the '291 patent's drawings and its written ...


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