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“Consisting Of” May Not Mean What You Think

April 06, 2004
Hartmann, Anthony A.

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Last Month at the Federal Circuit - May 2004

Judges: Newman (author), Friedman, and Schall (dissenting-in-part)

In Norian Corp. v. Stryker Corp., No. 02- 1490 (Fed. Cir. Apr. 6, 2004), the Federal Circuit affirmed-in-part and reversed-in-part various pre- and post-trial rulings of the district court regarding Norian Corporation’s (“Norian”) U.S. Patent Nos. 5,336,264 and 6,002,065 (“the ‘264 patent” and “the ’065 patent,” respectively).

Both patents are generally directed to certain rapidly setting calcium phosphate compositions (cements) for the repair of bones or teeth. The ‘264 patent claims methods of preparing these compositions comprising, inter alia, combining a calcium source, a phosphoric acid source, and a lubricant. The ‘065 patent claims recite kits for preparing these compositions “consisting of” at least one calcium source, at least one phosphoric acid source, and a solution consisting of water and a sodium phosphate.

Norian filed suit against Stryker Corporation (“Stryker”), alleging willful infringement by Stryker’s BoneSource® kit, which comprised a sodium phosphate component, a mixture of tetracalcium phosphate and dicalcium phosphate, a spatula, and instructions for combining the components.

The district court had found the specification’s use of “phosphoric acid source,” the only disputed term, to be different from its natural reading and construed the term to mean “an acid chemical that acts as a source of phosphate.” The Federal Circuit affirmed, in view of the specification and the lack of a contradictory prosecution history.

After affirming a jury determination that the claims of the ‘264 patent were obvious, the Federal Circuit addressed the district court’s denial of a motion for new trial on obviousness. Norian contended prejudice due to the jury having heard evidence of Norian’s misstatements to the PTO during prosecution of the ‘264 patent. Specifically, Norian’s counsel had admitted that a factual misstatement had been made regarding the prior art. While the district court ruled in a SJ determination that this did not constitute inequitable conduct, it instructed the jury to consider such evidence. The district court explained that “it was for purposes of allowing the jury to test the strength of the presumption that goes with the presumption of validity . . . whether or not the examiner really did understand what he was ruling . . . .”

The Federal Circuit noted that introspection and speculation into the Examiner’s understanding of the prior art or the correctness of the examination process is not part of the objective review of patentability. However, while the Court concluded that the district court had erred in the jury instructions, it noted that the motion for new trial was denied because Norian had failed to object to the instructions. In view of the failure to object and the entirety of the prosecution history, the Court affirmed the denial of a new trial.

With respect to anticipation, the Federal Circuit affirmed the district court’s ruling that the claims of the ‘264 patent are not anticipated by a certain extended abstract (“the Abstract”). The parties agreed that the Abstract described the ‘264 patent invention; however, Norian argued that the Abstract was not a publication under 35 U.S.C. § 102, because it was available only upon individual request to the authors. The Federal Circuit agreed that there was a lack of substantial evidence presented of dissemination of the Abstract.

The Federal Circuit reviewed the grant of Stryker’s SJ motion of noninfringement of the ‘065 patent. The district court had held “consisting of” to mean that kits include nothing beyond what is claimed and ruled that Stryker’s kit, which included a spatula, did not infringe as a matter of law. The Federal Circuit reversed and remanded, finding that the term “consisting of” permits no other chemicals in the kit, but that a spatula is not part of the invention that is described.

Judge Schall dissented from this finding of no infringement, explaining that it was inconsistent with the Court’s precedent, which precludes all components, and the public-notice function of patent claims. Judge Schall noted that there is nothing in the prosecution history to justify the majority’s claim construction and that Norian could easily have written the claims to permit mechanical components, but chose not to.

Finally, the Federal Circuit reviewed the district court’s grant of JMOL, dismissing the issue of willfulness after Norian had presented its case-in-chief. The Court noted that there is no evidentiary presumption of willfulness and it was not enough that Stryker had stipulated that it had knowledge of the Norian patents. The Federal Circuit agreed that Stryker never had the burden to rebut willfulness, since Norian never presented a prima facie case of willful infringement.