Smith & Nephew, Inc. v. Rea (Fed. Cir. 2013)

Smith & NephewLast week, in Smith & Newphew, Inc. v. Rea, the Federal Circuit reversed a decision of the Patent Trial and Appeal Board, finding U.S. Patent No. 7,128,744 (the '744 patent), which is owned by Synthes, to be obvious.  Smith & Nephew originally submitted a request for reexamination of the '744 patent, which was granted.  Upon review under reexamination, the Examiner found all of the claims of the patent to be obvious.  Synthes appealed the Examiner's decision to the Patent Trial and Appeal Board, which reversed the Examiner's decision with respect to certain claims (claims 1-23 and 32).  Smith & Nephew then appealed the Board's decision to the Federal Circuit.  Despite the deferential standard of review (substantial evidence) to be applied for a Board decision, the Federal Circuit found claims 1-23 and 32 to be obvious.

Both parties and the Court treated claim 1 as representative for all claims under appeal.  Claim 1 is related to a bone plating system designed to improve the stability of a bone fracture in a long bone.  The claimed system includes a plate with a shaft portion that runs along the outside of a fractured bone, and a flared head portion to accommodate the wider portion of the bone near a joint.  Predrilled holes are formed on both the shaft and the head portions of the plate.  The dispute in the case focused on the structure of the holes in the head portion of the plate; in particular, 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, as required by claim 1.

DePuySynthesA number of prior art references were applied.  First, the Court found that a prior art Synthes condylar buttress plate disclosed most of the limitations of claim 1 of the '744 patent, including a head portion of a plate with at least three screw holes.  An article by Kenneth Koval and an FDA submission by Synthes (dubbed the K982222 reference) each disclosed modifying the Synthes prior art plate to include partially threaded holes to engage the threads on the head of a locking screw.  A Synthes patent, U.S. Patent No. 5,709,686 (the '686 patent) disclosed anchor holes that were all partially threaded and intended to accommodate either locking screws or compression screws.  Another article, by N.P. Haas, disclosed holes in the head portion of a plate that were both conically tapered and partially threaded; however, unlike the other prior art plates, the Haas plate merely stabilized the femur and did not contact, let alone, compress, bone fragments directly.

The Board found that these prior art references did not teach or suggest the exclusive use of conical, partially threaded holes in a condylar buttress plate because it was not believed that conical, partially threaded holes could be used with non-locking (compression) screws to provide compression against a bone.  The Court held that the Board erred in its analysis, since claim 1 of the '744 patent does not require that the screws drilled into the head holes provide compression ("the patentability of the invention . . . turns on the structure of the holes, not the special nature of the non-locking screw"), and, contrary to Synthes' suggestion that compression is needed in the head portion of the plate, the specification of the '744 patent indicated that locking screws are sometimes used in all of the threaded holes of the head portion of the plate.

The Court also found the Board erred in determining the prior art showed that using a compression screw in a conical, partially threaded hole would cause the screw to undesirably protrude above the line of the plate.  The Court pointed to a chamfer disclosed in the Haas reference that could be used to countersink a screw head so that it does not sit above the top surface of the plate.  The Board had disregarded the Haas chamfer because a drawing in Haas showed the chamfer to be too narrow to prevent protrusion of a compression screw.  The Court held that the Board erred in disregarding the Haas chamfer, and that the chamfer should not be limited to the narrow one shown in the drawing, as chamfers are "conventional features in the art and can be sized to accommodate screw threads of varying heights."  The Court also reasoned that a person of ordinary skill in the art would not have necessarily selected a "rounded-bottom head" that would stick out from the plate, but would have chosen an appropriately shaped screw for the plate holes.

Finally, the Court held that the Board erred in relying on distinguishing the partially threaded, partly conical, holes discussed in the '686 patent from the fully conical threaded holes in the Haas reference for obviousness.  The Court noted that the '744 patent discloses that partially threaded holes, regardless of shape, could provide compression, and held that "a person of skill could adjust a plate hole's geometry -- whether conical, cylindrical, or otherwise -- to fit any standard screw without sacrificing compression."

Thus, the Court held that the motivation to combine the holes in the Haas reference with the prior art condylar plates was there:  the use of threads in all of the holes offers flexibility to the surgeon to choose either locking or non-locking (compression) screws in any of the holes in the head portion of the plate.

The Court additionally held that the Board should have considered two other prior art references that the Board had discounted because the Examiner had not relied on the references in making his rejections.  The fact that the Examiner had incorporated Smith & Nephew's arguments by reference (which included the two references) allowed for Board review of those references.  The Court held that the two references were "clearly probative" regarding whether it was known at the time of the invention that non-locking screws could be used in threaded holes.

Thus, the Court, despite taking a deferential approach to the Board's findings due to the substantial evidence standard of review, concluded that the Board erred in its decision, and reversed the Board's decision for claims 1-23 and 32.  In addressing the deference owed the Board, The Court noted that it did not dispute the Board's resolution of the factual questions of the case, and that the Board's decision was "mainly the result of the [Board's] analytical errors," as discussed above.

Smith & Nephew, Inc. v. Rea (Fed. Cir. 2013)
Panel: Circuit Judges Dyk, Bryson, and Wallach
Opinion by Circuit Judge Bryson

 

Topics:  Medical Devices, Patent Infringement, Patent Litigation, Patents, Prior Art, USPTO

Published In: Civil Procedure Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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