Medtronic, Inc. v. Barry

Citation891 F.3d 1368
Decision Date11 June 2018
Docket Number2017-1169, 2017-1170
Parties MEDTRONIC, INC., Appellant v. Mark A. BARRY, Appellee
CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit

Mark Christopher Fleming, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, argued for appellant. Also represented by Eric Fletcher ; Brittany Blueitt Amadi, Washington, DC; Ryan North Miller, Fox Rothschild, LLP, Philadelphia, PA; Jeff E. Schwartz, Washington, DC.

John C. Alemanni, Kilpatrick Townsend & Stockton LLP, Raleigh, NC, argued for appellee. Also represented by Sean Paul Debruine, Law Office of Sean DeBruine, Menlo Park, CA.

Before Taranto, Plager, and Chen, Circuit Judges.

Chen, Circuit Judge.

This is a consolidated appeal from two related decisions of the U.S. Patent and Trademark Office's Patent Trial and Appeals Board (Board) in inter partes review (IPR) proceedings. The Board concluded that the petitioner, Medtronic, Inc., had not proven that the challenged patent claims are unpatentable.

We affirm-in-part and vacate-in-part. Substantial evidence supports the Board's determination that the challenged claims would not have been obvious over two references: (1) U.S. Patent Application No. 2005/0245928 (the '928 Application) ; and (2) a book chapter which appears in Masters Techniques in Orthopaedic Surgery: The Spine (2d ed.) (MTOS). However, we vacate the Board's conclusion that certain other references, i.e., a video entitled "Thoracic Pedicle Screws

for Idiopathic Scoliosis" and slides entitled "Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and Kyphosis Surgery" (Video and Slides), were not prior art because the Board did not fully consider all the factors for determining whether the Video and Slides were publicly accessible. We thus remand for further proceedings.1

BACKGROUND

Medtronic manufactures surgical systems and tools used in spinal surgeries. In February 2014, spine surgeon Dr. Mark Barry sued Medtronic for patent infringement in the Eastern District of Texas. Barry alleged that Medtronic's products infringed a group of Barry's patents, including U.S. Patent Nos. 7,670,358 (the '358 Patent) and 7,776,072 (the '072 Patent). Medtronic then petitioned for, and the Board instituted, IPR proceedings for all claims in both patents.

I. The '358 Patent

The '358 Patent is directed to a method for ameliorating aberrant spinal column deviation conditions, such as scoliosis

. In addition to abnormal curvature of the spine, scoliosis may involve the rotation of vertebrae out of proper axial alignment. '358 Patent col. 2, ll. 51–56. The purported invention in the '358 Patent spreads corrective derotational (i.e., untwisting) forces across multiple vertebrae, thus reducing the risk of fracture during derotation. Id. at col. 3, ll. 15–25. The system includes pedicle screws implanted in the pedicle regions of vertebrae to which a surgeon, using a derotation tool, applies derotational forces. As a result, "the spinal column is manipulated en mass to achieve an over-all correction." Id. at col. 3, ll. 37–42.

Figure 1 of the '358 Patent shows a "pedicle screw cluster derotation tool" engaged with a spinal column:

As depicted in Figure 1, each pedicle screw cluster derotation tool (30) comprises a grouping of pedicle screw wrenches (32) connected by a linking member (42) to act in unison during use by a surgeon. Id. at col. 5, ll. 1–6. Each pedicle screw

wrench (32) includes a handle (34) and a shaft (36) having a distal end (38) ("pedicle screw engagement member"), which is engaged with the pedicle screw. Id. at col. 5, ll. 12–18.

By grasping the linked handles as a group ("handle means"), the surgeon can apply derotational forces during a spinal corrective procedure. Id. at col. 3, ll. 48–54. "[A]s manipulative forces are applied to the handle means ... [such] forces are transferred and dispersed simultaneously among the engaged vertebrae." Id. at col. 3, ll. 56–59.

Claim 1 of the '358 Patent is representative of the challenged claims for purposes of this appeal:

1. A method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions comprising the steps of:
selecting a first set of pedicle screws

, said pedicle screws each having a threaded shank segment and a head segment;

selecting a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having first handle means and a first group of pedicle screw engagement members which are mechanically linked with said first handle means, each pedicle screw engagement member being configured

for engaging with, and transmitting manipulative forces applied to said first handle means to said head segment of each pedicle screw of said first set of pedicle screws,
implanting a each [sic] pedicle screw

in a pedicle region of each of a first group of multiple vertebrae of a spinal column which exhibits an aberrant spinal column deviation condition;

engaging each pedicle screw engagement member respectively with said head segment of each pedicle screw of said first set of pedicle screws; and

applying manipulative force to said first handle means in a manner for simultaneously engaging said first group of pedicle screw engagement members and first set of pedicle screws and thereby in a single motion simultaneously rotating said vertebrae

of said first group of multiple vertebrae in which said pedicle screws are implanted to achieve an amelioration of an aberrant spinal column deviation condition ;

selecting a first length of a spinal rod member; wherein one or more of said pedicle screws of said first set of pedicle screws each includes:

a spinal rod conduit formed substantially transverse of the length of said pedicle screw and sized and shaped for receiving passage of said spinal rod member therethrough; and

spinal rod engagement means for securing said pedicle screw and said spinal rod member, when extending through said spinal rod conduit, in a substantially fixed relative position and orientation;

extending said first length of said spinal rod member through said spinal rod conduits of one or more of said pedicle screws of said first set of pedicle screws ; and

after applying said manipulative force to said first handle means, actuating said spinal rod engagement means to secure said vertebrae in their respective and relative positions and orientations as achieved through application of said manipulative force thereto.

'358 Patent, claim 1 (emphasis added). The issues raised in Medtronic's appeal concern the italicized language of claim 1 set out above. We will refer to the language as the "Simultaneously Rotating" limitation.

II. The '072 Patent

The '072 Patent is a continuation-in-part of the application that led to the '358 Patent and shares substantially the same specification.

Claim 1 of the '072 Patent is representative of the challenged claims of this patent, and, like Claim 1 of the '358 Patent, recites a derotation tool that engages with pedicle screws:

1. A system for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions comprising:
a first set of pedicle screw

, each pedicle screw having a threaded shank segment and a head segment; and

a first pedicle screw cluster derotation tool, said first pedicle screw cluster derotation tool having a first handle means for facilitating simultaneous application of manipulative forces to said first set of pedicle screws and a first group of three or more pedicle screw engagement members which are mechanically linked with said first handle means, said first handle

means configured to move simultaneously each pedicle screw engagement member;
wherein each pedicle screw engagement member is configured to engage respectively with said head segment of each pedicle screw of said first set of pedicle screws; and wherein each pedicle screw engagement member is configured to transmit manipulative forces applied to said first handle means to said head segment of each pedicle screw of said first set of pedicle screws.

'072 Patent, claim 1 (emphasis added). We will refer to the italicized claim language as the "Derotation Tool" limitation.

III. Relevant Prior Art

Medtronic submitted the following prior art references relevant to the issues raised in this appeal: (1) the '928 Application; (2) MTOS; and (3) Video and Slides.

A. '928 Application

The '928 Application is common to all of Medtronic's asserted grounds of obviousness that we consider on appeal. J.A. 1789–1805. The '928 Application discloses a tool ("the '928 device") for displacing vertebrae, relative to each other, during spinal surgery. J.A. 1789 at Abstract, J.A. 1798 at ¶ 8. "Displacement" in the '928 Application refers to the movement of two vertebrae either closer together (compression) or farther apart (distraction). The '928 Application discloses how a surgeon makes small incisions in the skin that are just large enough to insert the portions of the '928 device that engage pedicle screws

implanted in the vertebrae. J.A. 1801–02 at ¶ 46. The skin remains intact between these incisions, allowing the procedure to remain minimally invasive. J.A. 1799 at ¶ 24. Unlike the '358 or the '072 Patents, the surgical technique described in the '928 Application does not involve a large incision between the vertebrae that exposes substantial portions of the spine. See id. ; J.A. 1798 at ¶ 6.

B. MTOS

MTOS is a book chapter describing techniques of using pedicle screws

in the thoracic and lumbar spine. J.A. 2546–61. In one technique taught in MTOS, a surgeon places "correcting posts" on pedicle screws on both the convex and concave sides of the spinal curve and uses these posts to apply manipulative force in a spinal derotation procedure. J.A. 2557. MTOS describes performing multiple "apical vertebral derotation" (AVD) maneuvers to derotate the spine but does not explicitly disclose manipulating multiple posts simultaneously as part of the AVD maneuvers. J.A. 2557–60.

C. The Video and Slides

Medtronic distributed a video demonstration and a...

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