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Spine v. Biedermann Motech GMBH

November 15, 2010

STRYKER SPINE, PLAINTIFF,
v.
BIEDERMANN MOTECH GMBH, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge

MEMORANDUM OPINION

This case involves a dispute between Plaintiff Stryker Spine ("Stryker"), a French corporation, and Defendants Biedermann Motech GmbH ("Biedermann") and DePuy Spine, Inc. ("DePuy"), over a patent interference proceeding at the United States Patent and Trademark Office ("PTO"). Stryker seeks judicial review of decisions made by the PTO's Board of Patent Appeals and Interferences (the "Board") pursuant to 35 U.S.C. § 146. In a prior ruling issued on February 16, 2010, the Court denied Stryker's motions for summary judgment and granted-in-part and denied-in-part Defendants' motion for summary judgment. See Stryker Spine v. Biedermann Motech GmbH, 684 F. Supp. 2d 68 (D.D.C. 2010). The Court found that there were genuine issues of material fact relating to whether the Board erred by failing to redefine the interference count to account for two alleged patentably distinct inventions. Accordingly, the Court held a bench trial to hear the parties' evidence regarding this issue. This Memorandum Opinion sets forth the Court's findings of fact and conclusions of law.

The bench trial was held over two days on August 25 and 26, 2010. Stryker called one witness, Dr. Bret A. Ferree, to testify as an expert in the fields of orthopedic surgery, spinal surgery, spinal bone fixation technology, and pedicle fixation assemblies. Defendants also called one witness, Dr. Erik K. Antonsson, to testify as an expert in the field of mechanical engineering and the application of mechanical engineering principles to orthopedic medical devices. Prior to the trial, Stryker filed a [66] Motion in Limine to Exclude Expert Testimony of Dr. Erik K. Antonsson. The Court took Stryker's motion in limine under advisement prior to and during the bench trial and allowed Dr. Antonsson to present his testimony on the record. Following the bench trial, the parties submitted proposed findings of fact and conclusions of law with citations to the record.

Having considered the evidence presented during the bench trial, the parties' proposed findings of fact and conclusions of law, the relevant authorities, and the record as a whole, the Court concludes that the Board properly declared a single interference count that does not encompass two patentably distinct inventions. Accordingly, Defendants are entitled to judgment on Stryker's claim that the Board erred by failing to redefine the interference count into two separate counts. Because the remainder of Stryker's claims are contingent upon a redefined interference count, the Court shall enter final judgment for Defendants and dismiss this action.

I. FINDINGS OF FACT*fn1

The following findings of fact are based on the administrative record,*fn2 the evidence (testimony and exhibits) submitted by the parties during the bench trial, the parties' stipulations of undisputed facts, and the record as a whole.

A. Stryker's Patent (the '460 Patent)

Plaintiff Stryker Spine ("Stryker") is the assignee of U.S. Patent No. 6,974,460 ("the '460 Patent"), which is titled "Biased Angulation Bone Fixation Assembly." See Joint Ex. ("JX")*fn3 1 (the '460 Patent). John Carbone, Aaron Markworth, Michael Horan, and Yves Crozet are named as the inventors of the '460 Patent. Id.;Stip. Fact*fn4 ¶ 4. The '460 Patent was issued on December 13, 2005. JX 1 at 1.

The invention described by the '460 Patent relates to spinal fixation devices, more specifically, pedicle fixation assemblies. JX 1 at col. 1, lines 12-14. Spinal fixation is a surgical technique in which surgical implants are used to fuse together and/or mechanically immobilize two or more vertebral bodies of the spinal column. See id. at lines 41-44. One technique for spinal fixation involves immobilizing the spine using orthopedic stabilizing rods, or spine rods, fastened with bone screws into the pedicles of vertebral bodies. See id. at lines 55-60. Under prior patents identified in the '460 Patent, the pedicle screw (or anchoring element) has a spherically shaped head that fits within a rod capturing assembly (which captures the spine rod) so as to permit movement of the assembly relative to the pedicle screw. See id. at col. 2, lines 29-40.

According to the inventors of the '460 Patent, there was a need for spinal fixation devices that provide a greater degree of angulation between the rod capturing assemblies and the anchoring elements. Id. at lines 41-47. Therefore, one stated goal of the '460 Patent is to provide for a bone fixation assembly that allows greater angulation so that the rod capturing assembly can be manipulated to cover a broader range of angles for capturing an orthopedic stabilizing rod. Id. at lines 64-67. A further goal of the '460 Patent is to provide for greater "biased" angulation, meaning that there is greater angulation in one direction compared to another. See id.; Tr. (8/25/10 AM) at 86:22-87:5 (Testimony of Dr. Bret Ferree).

The '460 Patent contains 39 claims, five of which are independent (claims 1, 18, 24, 33, and 38). Stip. Fact ¶ 11. Independent claim 1 of the '460 Patent reads as follows:

1. A bone fixation assembly comprising:

a coupling element having an inner surface defining a first bore coaxial with a first longitudinal axis and a second bore coaxial with a second longitudinal axis, wherein said first and second longitudinal axes intersect and are in communication with one another; said coupling element including a seat adjacent said lower end of said coupling element, said seat being defined by the inner surface of said coupling element; and an anchoring element assembled with said coupling element, said anchoring element having a first end for insertion into bone and a head spaced from the first end, said head being in contact with seat of said coupling element.

JX 1 at col. 15, lines 42-55; Stip. Fact ¶ 41. Claim 1 thus requires a coupling element with two bores having intersecting longitudinal axes.

Independent claim 18 of the '460 Patent reads as follows:

18. A bone fixation assembly comprising: a coupling element having an upper end defining a first plane, a lower end defining a second plane, and at least one bore extending from said upper end toward said lower end, wherein said first and second planes intersect one another; an anchoring element assembled with said coupling element, said anchoring element being adapted for insertion into bone; and said coupling element having a U-shaped opening that extends from the upper end of said coupling element toward the lower end of said coupling element, wherein said U-shaped opening is adapted to receive a stabilizing rod.

JX 1 at col. 16, lines 50-63; Stip. Fact ¶ 43. Claim 18 thus requires end surfaces defining planes, with the upper and lower planes intersecting. Claim 18 calls for "at least one bore" but does not require two bores.

B. Defendants' Patent Application & Suggestion of Interference Defendant

Biedermann is the assignee of U.S. Patent Application No. 10/763,431 ("the '431 Application"), which is titled "Bone Screw." Stip. Fact ¶ 9; JX 2 (the '431 Application) at 1. Defendant DePuy has been identified as the exclusive licensee of the '431 Application. Stip. Fact ¶ 10. The '431 Application was filed on January 22, 2004. Stip. Fact ¶ 22. The '431 Application claimed to be a continuation of Application No. 10/037,698, filed November 9, 2001, which claimed priority from German Application No. 10055888.7, filed November 10, 2000, and German Application No. 10065397.7, filed December 27, 2000. JX 2 at 1. The named inventors for the '431 Application are Lutz Biedermann and Jurgen Harms. Stip. Fact ¶ 8.

Like the '460 Patent, the '431 Application describes a device that connects a bone screw to a coupling element for the receipt of an anchoring rod. The abstract of the '431 Application reads as follows:

A bone screw having a screw member (1) possessing a threaded section (2) and a head (3) and a receiving part (5) at the head end for receiving a rod to be connected to the bone screw is provided. The receiving part (5) has on [sic] open first bore (6) and a substantially U-shaped cross-section having two free legs provided with a thread. Furthermore, the receiving part has a second bore (7) on the end opposite to the first bore (6) whose diameter is greater than that of the threaded section (20 and smaller than that of the head (3). On the bottom of the first bore a seat for the head (3) is provided. In order that the screw member can be pivoted to at least one side by an enlarged angle, the edge bounding the free end of the second bore (7) viewed relative to the axis of the first bore (6) is of asymmetric construction.

JX 2 at 1 (figures omitted).

On July 9, 2004, Beidermann filed a "Request for Declaration of Interference Under 37 CFR 1.604(a)" between the '431 Application and the application for the '460 Patent. See JX 3 ('431 Application File History) at DPS00558-69. Biedermann proposed two interference counts, one of which was directed to an "assembly or coupling element" as described by either claims 1-9, 11-13, 15-18, 20, 22-31, 34-37, 41 and 42 of the '460 Patent or claims 6-35 and 40-42 of the '431 Application, and the other of which was directed to a "method" as defined by either claims 44-47 of the '460 Patent or claims 36-39 of the '431 Application. JX 3 at DPS000559. On January 10, 2006, Biedermann filed a "Suggestion of Interference Under 37 CFR 41.202(a)" proposing only a single count of interference directed toward an assembly or coupling element. JX 3 at DPS000471-85. On May 16, 2007, Biedermann filed a "Supplemental Suggestion of Interference" with the PTO. See JX 3 at DPS000348-63. Biedermann proposed what it called a "Simplified McKelvey Count," defined as "[t]he assembly or coupling element of Carbone claims 1, 18, 24, 33, or 38, or the assembly or coupling element of Biedermann claims 6, 18, 28, 33 or 35." JX 3 at DPS000351. Biedermann explained that the simplified McKelvey count "has the advantage of combining the parties' independent claims, which are not patentably distinct from one another, while sweeping in the remaining dependent claims, which do not add features that render their subject matter as a whole each separately patentable over the parties' combined independent claims." Id.

C. The Interference Proceeding

On October 10, 2007, the Board issued a notice declaring Patent Interference No. 105,578 involving the '460 Patent and the '431 Application. Stip. Fact ¶ 12; Admin. R. ("AR") 2-7. Administrative Patent Judge (APJ) Jameson Lee was assigned to manage the interference proceeding. AR 3; Stip. Fact ¶ 29. The inventors of the '431 Application (Biedermann and Harms) were identified as the senior party, whereas the inventors of the '460 Patent (Carbone et al.) were identified as the junior party. AR 4; Stip. Fact ¶ 23. The interference was declared on the basis of a single count ("Count 1"), defined as claim 1, 18, 24, 33, or 38 of the '460 Patent or claim 6, 18, 28, 33, or 35 of the '431 Application. Stip. Fact ¶ 23; AR 5. All remaining claims of the '460 Patent and the '431 Application were said to "correspond to" the sole interference count, such that they would rise or fall with the count itself. Stip. Fact ¶ 23. The interference count was later redeclared to substitute Biedermann's claim 22 for Biedermann's claim 18. See AR 153-54; Stip. Fact ¶ 30.

During a motions conference held on December 5, 2007, Stryker explained its proposal to file a motion to redefine the interference by replacing Count 1 with two new counts, Count 2 and Count 3. Stip. Fact ¶ 31; AR 156-61. In an order dated December 6, 2007, APJ Lee authorized Stryker to file a motion to redefine the interference. Stip. Fact ¶ 32; AR 160. On February 15, 2008, Stryker filed its "Revised Substantive Motion 1" to redefine the interference. Stip. Fact ¶ 33;AR 307-59. Claims 1, 24, or 38 of the '460 Patent and claims 6, 28, or 35 of the '431 Application define what Stryker called proposed Count 2. Stip. Fact ¶ 37; AR 319. Claims 18 or 33 of the '460 Patent and claims 22 or 33 of the '431 Application define what Stryker called proposed Count 3. Stip. Fact ¶ 38; AR 320. In its motion, Stryker argued that Count 1 "includes two separate inventions which are patentably distinct from each other, and that it is therefore inappropriate to include these two separate inventions in a single count." AR 310. Stryker explained that the first invention, expressed by Count 2, is represented by claim 1 of the '460 Patent. AR 311. Stryker explained that the second invention, expressed by Count 3, ...


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