Smith & Nephew, Inc. v. Rea

721 F.3d 1371, 107 U.S.P.Q. 2d (BNA) 1433, 2013 WL 3388454, 2013 U.S. App. LEXIS 13780
CourtCourt of Appeals for the Federal Circuit
DecidedJuly 9, 2013
Docket2012-1343
StatusPublished
Cited by10 cases

This text of 721 F.3d 1371 (Smith & Nephew, Inc. v. Rea) 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
Smith & Nephew, Inc. v. Rea, 721 F.3d 1371, 107 U.S.P.Q. 2d (BNA) 1433, 2013 WL 3388454, 2013 U.S. App. LEXIS 13780 (Fed. Cir. 2013).

Opinion

BRYSON, Circuit Judge.

Appellant Smith & Nephew, Inc., seeks review of a decision of the Board of Patent Appeals and Interferences (now known as the Patent Trial and Appeal Board). Reversing the decision of a patent examiner, the Board held that certain claims of a patent owned by appellee Synthes (U.S.A.) would not have been obvious and therefore were not invalid. Both Synthes and the Acting Director of the Patent and Trademark Office have filed briefs supporting the Board’s decision. While the “substantial evidence” standard of review for the Board’s factual findings makes Smith & Nephew’s burden on appeal a heavy one, we are satisfied, after careful review, that Smith & Nephew has met that burden and has shown that the claims at issue would have been obvious. We therefore reverse the decision of the Board.

I

Synthes owns U.S. Patent No. 7,128,744 (“the '744 patent”). The patent was issued in 2006, and it claims priority to a provisional application filed on September 13, 1999. The patent is directed to a system for using plates to repair bone fractures in long bones, such as the femur. The bone plate that is the subject of the patent runs along the outside of the fractured bone and is attached by bone anchors (typically, bone screws) that are inserted through predrilled holes in the plate and then into the bone. The dispute in this case focuses on the structure of the holes in the plate through which the screws are inserted.

In 2009, Smith & Nephew requested reexamination of the '744 patent, and the Patent and Trademark Office granted the request. After reviewing detailed eviden-tiary submissions, the examiner rejected all 55 claims of the '744 patent as obvious based on a number of prior art references. Synthes appealed the rejections to the Board of Patent Appeals and Interferences, which upheld the rejections of 31 of the claims (claims 24-31 and 33-55), but reversed the rejections of 24 of the claims (claims 1-23 and 32). Smith & Nephew appeals from the Board’s decision with respect to the 24 claims on which the Board reversed the rejections.

A

The parties have treated claim 1 as representative of the 24 claims of the '744 patent that survived the reexamination, and we do the same. Claim 1 recites a bone plating system for improving the stability of a bone fracture in a long bone, comprising a bone plate having a shaft portion that is configured to run along a portion of the bone and a head portion that flares out from the shaft portion so as to accommodate the wider portion of the bone near a joint. The head portion has at least three bone anchor holes, all of which are conically tapered from the top surface *1374 of the plate to the bottom surface. 1 All of the holes in the head portion are at least partially threaded to engage the threads on the head of a “locking” bone anchor (or screw). The shaft portion of the claimed plate has a plurality of holes in which at least a portion of the hole is threaded. The central issue in this case is whether it would have been obvious at the time of the invention to design a bone plate in which all of the holes in the plate’s head portion were conically tapered and at least partially threaded to engage threaded “locking” screws.

The '744 patent describes two basic types of screws that were used in prior art bone plates. First are nonlocking compression screws, which have threaded shafts but unthreaded heads and which typically pass through unthreaded holes in the plate. Upon being tightened, the compression screws draw the bone and plate together. Second are locking screws, which have threaded heads as well as threaded shafts. The threads on the heads of the locking screws engage with corresponding threads on the interior of the anchor holes in the plate, which results in fixing the screws to the plate.

The two types of screws perform different functions: compression (non-locking) screws draw the bone and the plate together for fracture reduction and quicker healing, while locking screws fix the relative position of the plate and bone so that the plate does not move relative to the bone. See '744 patent, col. 1, line 64-col. 2, line 7. The latter feature is especially important when the bone is a weight-bearing bone that is subject to pressure that can loosen the connection between the screws and the plate if only conventional compression screws are used to attach the plate to the bone.

Several commercial bone plates, as well as articles and descriptions of bone plates, are acknowledged to be prior art to the '744 patent. First is a condylar buttress plate that Synthes marketed in the 1990s. Designed for fractures in the femur near the knee, the Synthes plate had a shaft and head portion, both of which contained unthreaded holes designed for compression screws.

A 1997 article by Kenneth Koval described a modified version of the Synthes condylar buttress plate. In the Koval plate, threaded nuts were welded onto the top of four of the six holes in the head portion of the plate, enabling the use of locking screws in those holes.

In a 1998 prior art submission to the Food and Drug Administration, referred to as the K982222 application, Synthes sought permission to market a plate having four threaded holes and two unthreaded holes in the head portion of the plate. That device, like the Koval plate, allowed locking screws to be used in the head portion. The Koval plate and the K982222 application followed the suggestion in a 1996 article by Brett R. Bolhofner (one of the inventors of the '744 patent) and others, which noted a means of solving the problem that screws “can angulate ... and are not fixed in a constant relationship” to the plate by “selective locking of the screws to the plate.”

In 1997, N.P. Haas published an article describing a version of the Synthes plate *1375 that used only conically tapered, threaded holes in the shaft and head portions of the plate. Unlike other prior art plates, this one merely stabilized the femur and did not compress or even contact bone fragments directly.

The prior art background also included plates for fractures not involving the femur. During the 1990s Synthes marketed a Distal Radius Plate (“DRP”) for wrist fractures. The anchor holes of the DRP were all partially threaded and, importantly, were specifically designed for use with either locking screws or non-locking, compression screws. In 1997 Synthes marketed another device, known as the Locking Reconstruction Plate (“LRP”), which was designed to serve as an internal fixation plate for a lower jaw fracture. That plate, and a patent application for a similar device that ultimately issued as U.S. Patent No. 5,709,686 (“the '686 patent”), featured anchor holes that were all partially threaded and were intended to accommodate either locking screws or compression screws. 2 The screw holes in the LRP had a threaded lower portion and an unthread-ed, conically flared upper portion that enabled the screws to be countersunk so that the heads of the screws did not extend above the surface of the plate.

At the conclusion of the reexamination, the examiner rejected all of the claims of the '744 patent.

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721 F.3d 1371, 107 U.S.P.Q. 2d (BNA) 1433, 2013 WL 3388454, 2013 U.S. App. LEXIS 13780, Counsel Stack Legal Research, https://law.counselstack.com/opinion/smith-nephew-inc-v-rea-cafc-2013.