Bruce Saffran v. Johnson & Johnson

712 F.3d 549, 106 U.S.P.Q. 2d (BNA) 1274, 2013 WL 1338910, 2013 U.S. App. LEXIS 6795
CourtCourt of Appeals for the Federal Circuit
DecidedApril 4, 2013
Docket2012-1043
StatusPublished
Cited by21 cases

This text of 712 F.3d 549 (Bruce Saffran v. Johnson & Johnson) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Bruce Saffran v. Johnson & Johnson, 712 F.3d 549, 106 U.S.P.Q. 2d (BNA) 1274, 2013 WL 1338910, 2013 U.S. App. LEXIS 6795 (Fed. Cir. 2013).

Opinions

Opinion for the court filed by Circuit Judge LOURIE, in which Circuit Judge MOORE joins except as to Parts II-A-2 and II-B-2, and in which Circuit Judge O’MALLEY joins except as to Parts II-A-1 and II-B-1.

Opinion concurring in part filed by Circuit Judge MOORE.

Opinion concurring in part filed by Circuit Judge O’MALLEY.

LOURIE, Circuit Judge.

Johnson & Johnson and Cordis Corporation (collectively, “Cordis”) appeal from the final judgment of the United States District Court for the Eastern District of Texas in favor of Dr. Bruce N. Saffian (“Saffian”), in which the district court held Cordis liable for infringing claims 1-3, 6, 8, 9, 11, 13, 15, and 17 of Saffran’s U.S. Patent 5,653,760 (the “ '760 patent”). Saffran v. Johnson & Johnson, No. 2:07-cv-451 (E.D. Tex. Mar. 31, 2011), ECF No. 326 (“Final Judgment”). We conclude that the district court erroneously construed the claims of the '760 patent and that, under the correct construction, Cor-dis is entitled to a judgment of nonin-fringement as a matter of law. Accordingly, we reverse.

I. Background

Saffian is the owner and sole named inventor of the '760 patent, which is entitled “Method and Apparatus for Managing Macromolecular Distribution” and concerns “the treatment of injured tissues within human or animal bodies, specifically ... the way injured tissues are joined and the way macromolecules are directed to promote healing.” '760 patent col. 111. 21-24. In particular, the '760 patent discloses methods and devices for treating injured tissues by sequestering particles and macromolecules in a defined space using a selectively permeable barrier.

The specification primarily describes the invention in terms of a strategy for treating serious bone fractures, known as complex or comminuted fractures, where the bone has been shattered into numerous fragments. In such cases, standard treatment may involve surgical intervention to align the bone fragments and affix a stabilizing device across the fracture site in order to enable new bone to form between, and eventually unite, the fragments during healing. The specification teaches that such complex fractures often heal poorly, requiring repeated operations and leading to permanent disability. See id. col. 1 1. 43 — col. 2 1.16.

The specification describes several cellular and molecular processes that may influence clinical outcomes following a complex fracture. For one, cells at the site of injury secrete growth-promoting proteins (growth factors) into the interfragmentary spaces, where those proteins can, in sufficient concentrations, stimulate cellular proliferation and the assembly of a “scaffolding” matrix between fragments that serves as a prelude to new bone formation. If the local concentration of growth factors is too low, the scaffolding process does not occur — small bone fragments instead remain isolated and are eventually absorbed by the body, leaving persistent and ever-larger gaps between the major fragments. In addition, when bone growth factors diffuse away from the fracture site and into adjacent soft tissues, they can spur calcifi[552]*552cation and heterotopic bone growth within the muscles, which can permanently limit the patient’s range of motion. Id. col. 2 11. 17-64.

To improve the treatment of such injuries, the '760 patent discloses “a unique method of fracture stabilization and a means to restrain interfragmentary macromolecules using a single, flexible minimally porous sheet.” Id. col. 7 11. 34-36. For purposes of the '760 patent, substances larger than about 500 daltons1 (e.g., proteins and many drugs) are considered macromolecules. Id. col. 8 11. 3-6. The single-layered sheet serves as a selective barrier that blocks macromolecules and larger particles, such as tissue fragments and cells, yet contains micropores sized to allow free passage for small molecules (e.g., water). See id. col. 13 11. 39-57. Other sheets might be designed to screen molecules according to properties such as ionic charge or hydrophobicity rather than size. Id. col. 8 11. 15-24. Once selected and cut to the desired size and shape, the sheet (1) is wrapped around or affixed to the fracture site, for example, with staples (6), as shown below.

[[Image here]]

'760 patent fig. 4a; see also id. col. 16 11. 13-47. Because of the invention’s barrier properties, the growth factors and other macromolecules (8) produced by the injured tissues at the fracture site are restrained and concentrated within the inter-fragmentary spaces (4), as illustrated in a cross-sectional diagram of the device after implantation:

[553]*553'760 patent fig. 4b. In addition to preformed sheets, the specification also discloses that “the invention can be applied to the site of injury as a spray ... such that it is deposited as a thin film on the tissue ... to maximize the surface area being treated while minimizing the need to dissect and staple.” I’d. col. 18 11. 2£M!7.

Id. fig. 6a; see also id. fig. 6b.

In addition to its above-described properties, the sheet can also be configured to deliver a drug or other therapeutic agent (a “treating material”) to the treatment site. In such embodiments, the '760 patent teaches that the treating material “is affixed directly to one surface of the minimally-porous sheet.” Id. col. 8 11. 31-32. In particular, the '760 patent describes affixing a treating material (12) to one side of the sheet (1) through a hydrolyzable chemical bond (24), which in the preferred embodiment can be severed to release the treating material by means of water molecules present at the treatment site.2 Id. col. 14 11. 65-67. Figure 3a of the '760 patent represents a sheet configured for drug delivery as described above:

'760 patent fig. 3a. Lysis of the bonds occurs at a constant rate, releasing a steady dose of treating material. Id. col. 14 1. 43 — col. 15 1. 20, col. 22 11. 4-17.

[554]*554Moreover, because the released treating material (10) is too large to pass through the minimally porous sheet, the disclosed device can deliver such therapeutics in a spatially directed manner — generally, the treating material is delivered from and then maintained adjacent to the side of the sheet facing the injured tissue, as illustrated in the '760 patent:

'760 patent fig. 3b.

As another use for the invention, the '760 patent also describes intravascular stents incorporating the disclosed technology. See id. col. 20 1. 9 — col. 21 1. 3. According to the specification, vascular plaques form in response to microscopic injuries to a blood vessel wall: “When the vessel attempts to heal, neighboring cells [secrete] a series of macromolecules to ‘patch’ the defect. If the macromolecules are not kept substantially in place, they will be swept away by moving blood.... [T]he sooner the injury is repaired, the smaller the resulting plaque will be.” Id. col. 20 11. 14-21. In this regard, the '760 patent criticizes prior art stents consisting of an open wire mesh because the holes (27) in the mesh between adjacent stent struts (29) are so large that “both cells and macromolecules [ (8) ] are free to move through them” and into the blood vessel lumen (38), id. col. 20 11. 34-38, as illustrated below.

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Bluebook (online)
712 F.3d 549, 106 U.S.P.Q. 2d (BNA) 1274, 2013 WL 1338910, 2013 U.S. App. LEXIS 6795, Counsel Stack Legal Research, https://law.counselstack.com/opinion/bruce-saffran-v-johnson-johnson-cafc-2013.