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Combination of Prior Art Elements, Each Used According to Their Established Functions, Without a Surprising Result, Invalidates Bone Plate Patent
Thursday, August 1, 2013

In a case arising from two inter partes reexaminations, the U.S. Court of Appeals for the Federal Circuit reversed a decision of the Patent Trial and Appeal Board (Board) and concluded that the claimed subject matter would have been obvious.  Smith & Nephew, Inc. v. Rea, Case No. 12-1343 (Fed. Cir., July 9, 2013) (Bryson, J.). 

Smith & Nephew requested reexamination of a patent assigned to Synthes.  On reexamination, the examiner rejected all of the patent’s claims as obvious. The Board reversed the rejections of some claims.

The patent claimed a system for using plates to repair fractures in long bones. The dispute focused on the structure of holes in a head portion of the plate through which screws are inserted. The representative claim required at least three screw holes in the head portion that are conically tapered from the top surface of the plate to the bottom surface and that are at least partially threaded to engage the threads on the head of a screw. Although not required by the claim, the specification indicated that the holes could advantageously be used with both locking screws, which have threaded heads, and compression screws, which have heads without threads.

A prior art Synthes plate satisfied all of the claim limitations except for the holes’ configuration. The prior art also included a modified version of the prior art Synthes plate with threaded holes and another plate having a mix of threaded and unthreaded holes. A prior art article suggested “selective locking of the screws to the plate” as a solution to the problem that screws “can angulate . . . and are not fixed in a constant relationship.”  Smith & Nephew appealed. 

The Board ruled that removing the non-threaded holes from the head portion of the prior art plates would not have been expected to allow the plates to impart compression between the head portion and the bone.

On appeal, the Federal Circuit criticized the Board ruling that the claim did not require compression. The Federal Circuit explained that “[t]he patentability of the invention . . . turns on the structure of the holes, not the special nature of the non-locking screw that is to be used with those holes.”

The Federal Circuit also criticized the Board’s analysis for failing to read the prior art for all that it teaches. Another modified version of the prior art Synthes plate used only conically tapered, threaded holes. However, the Board disregarded the conical geometry of this plate because it concluded that conventional compression screws would sit too high in these holes and therefore cause complications to the patient.

Additionally, the Federal Circuit criticized the Board’s analysis for failing to consider prior art plates that supported rebuttal of Synthes’s argument that the prior art combinations would have been inoperable. Two prior art Synthes plates, for fractures in other types of bones, that included only partially threaded holes for using either locking screws or compression screws.  The holes of one of these two plates also included unthreaded, conically flared upper portions.

The Federal Circuit concluded that compelling evidence indicated that it would have been obvious to modify prior art plates to have only threaded holes in the head portion.

The Federal Circuit also concluded that it would have been obvious to combine the partially threaded, untapered holes of the prior art plates, with the conically tapered, partially threaded holes of the prior art stabilization plate, observing that no evidence before the Board indicated that the claimed conically tapered holes “would produce a surprising result or involve anything more than a choice among designs already found in the prior art.”

Because conical, partially threaded holes were well known in the art, as was the advantage of adding more of them to the head in place of unthreaded holes, and the screws and the holes perform their conventional, expected function in securing the plate, the Federal Circuit concluded that claims would have been obvious.

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