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Failure to Enable Claimed Invention Without Unrecited Elements May Invalidate Otherwise Enabled “Comprising” Claims

06-1156
March 22, 2007
Raich Ph.D., William B.

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Last Month at the Federal Circuit - April 2007

Judges: Lourie (author), Rader, Bryson

[Appealed from: S.D. Ohio, Judge Beckwith]

In Liebel-Flarsheim Co. v. Medrad, Inc., Nos. 06-1156, -1157 (Fed. Cir. Mar. 22, 2007), the Federal Circuit affirmed the district court’s grant of SJ in favor of Medrad, Inc. (“Medrad”), holding that two patents asserted by Liebel-Flarsheim Company and Mallinckrodt, Inc. (collectively “Liebel”) are invalid for lack of enablement and two others are invalid for anticipation.

U.S. Patent Nos. 5,456,669 and 5,658,261 (collectively “the front-loading patents”) share a common specification and are directed to a front-loading fluid injector with a replaceable syringe capable of withdrawing high pressures for delivering a contrast agent to a patient. The claims in the originally filed application that gave rise to these patents expressly recited a “pressure jacket” associated with the high-pressure injector, and all of the disclosed embodiments included a pressure jacket. During prosecution, Liebel removed the references to a pressure jacket, and the issued claims do not explicitly recite a pressure jacket but recite the inclusive transitional phrase “comprising.” Notably, the injector in Medrad’s accused product did not include a pressure jacket.

U.S. Patent Nos. 5,662,612 and 5,928,197 (collectively “the syringe-sensing patents”) also share a common specification but are directed to a computer-controlled injector wherein a motor advances and retracts a plunger located within the syringe. The claims in the syringe-sensing patents recite a detector for detecting “physical indicia” on a syringe, where the indicia are related to the capacity of the syringe.

In an earlier appeal to the Federal Circuit, Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004) (“Liebel I”), the Court reversed the district court’s claim construction that the claims required a pressure jacket and determined that the asserted claims of the front-loading patents did not require a pressure jacket. The Court reasoned that none of the asserted claims expressly mention a pressure jacket, the disclosure does not clearly disavow embodiments lacking a pressure jacket, and the prosecution history indicates that the claims purposefully did not claim a pressure jacket.

On remand, in light of the claim construction in Liebel I, the district court concluded that Medrad’s devices infringed the asserted claims of the frontloading patents, but held that the claims were invalid as failing to comply with the written description and enablement requirements of 35 U.S.C. § 112.

With regard to enablement, the district court noted that the inventors of the front-loading patents admitted to their own unsuccessful experiments with jacketless systems. The district court also relied on the testimony of Liebel’s engineers that a jacketless system was not a mere design option and that one of skill in the art would not know how to make a jacketless system. Finally, the district court found that no prototypes of a jacketless injector had been made or described at the time of filing, and that the state of the art was such that a jacketless system would have been a “true innovation.” Slip op. at 6. The district court also explained that the claims were invalid for lack of written description because the specification of the front-loading patents did not describe a jacketless injector.

On appeal, the Federal Circuit affirmed the district court’s holding that the asserted claims of the front-loading patents were invalid for lack of enablement and reiterated that claims must be enabled across their full scope. The Court agreed with Medrad that, although every embodiment need not be disclosed in the specification, the disclosure must teach the full range of embodiments in order for the claims to be enabled, and here the specification did not teach an injector without a pressure jacket. Moreover, the specification taught away from a jacketless injector by describing jacketless syringes as “impractical.” The Court also cited to the testimonial evidence, noting that the inventors themselves admitted that they tried unsuccessfully to produce a jacketless system, and that they decided not to pursue such a system because it was “too risky.” Id. at 13.

Citing precedent, the Court emphasized that the quid pro quo of the patent bargain required the applicant’s specification to enable one of ordinary skill in the art to practice the full scope of the claimed invention. The Court suggested that Liebel overreached in amending its claims during prosecution to read on jacketless injectors, stating that “having won that battle,” enablement presented a challenge that Liebel “could not meet.” Id. at 15.

Because the Court resolved the case on the enablement ground, the Court did not consider the written description holding of invalidity.

With regard to the syringe-sensing patents, the Federal Circuit in Liebel I held that the district court correctly determined that the claim term “physical indicia” was not limited to indicia related to the length of an extender because the claims recited syringe properties other than the length of the extender.

On remand and in light of the claim construction, the district court found that Medrad’s device infringed the asserted claims of the syringe-sensing patents, but that those claims were invalid as anticipated and for lack of adequate written description. The district court found that there was nothing in the written description that described an invention for detecting indicia, other than a limited reference to a physical indicia relating to the length of the extender. With regard to anticipation, the district court found that the asserted claims of the syringe-sensing patents were anticipated by Medrad’s U.S. Patent No. 5,383,858 (“the ’858 patent”). In particular, the district court held that the ’858 patent disclosed “physical indicia” related to the “capacity” of the syringe by describing the use of a bar code that stored information about the device, such as information relating to the “dimensions” of the syringe. The district court found that distinctions between “capacity” and “dimensions” were “semantic differences” that did not affect its conclusion of anticipation.

On appeal, the Federal Circuit held that the district court correctly determined that there was no genuine issue of material fact that the ’858 patent anticipated the asserted claims of the syringe-sensing patents. The Federal Circuit agreed with the district court that detecting “dimensions” of the syringe, as disclosed in the ’858 patent, permitted calculation of capacity using a basic volumetric formula. The Court again noted that Liebel argued for a broad meaning during prosecution, and succeeded, but consequently “suffer[ed] a Pyrrhic victory.” Id. at 20.