Roche Diagnostics Operations, Inc. v. Lifescan Inc.

452 F. App'x 989
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 25, 2012
Docket2010-1439, 2010-1539
StatusUnpublished
Cited by4 cases

This text of 452 F. App'x 989 (Roche Diagnostics Operations, Inc. v. Lifescan Inc.) 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
Roche Diagnostics Operations, Inc. v. Lifescan Inc., 452 F. App'x 989 (Fed. Cir. 2012).

Opinion

PROST, Circuit Judge.

Roche Diagnostics Operations, Inc. and Corange International Limited (collectively “Roche”) appeal from a judgment of non-infringement that the district court entered in favor of Lifescan Incorporated (“Lifescan”) and Nova Biomedical Corporation (“Nova”). Only two claim construction issues are before us with respect to the judgment of non-infringement: one raised by Roche, the other raised by Nova. Roche argues that the district court erred in construing the term “electrode” in the asserted patent claims and that the judgment of non-infringement should thus be vacated. Nova disagrees with Roche’s argument, of course, but it also argues that in the alternative, the judgment of non-infringement could be affirmed on the ground that the district court’s construction of the term “detecting” was erroneous. We see no error in the district court’s construction of “detecting” and thus reject Nova’s argument. The argument raised by Roche regarding “electrode,” however, has not been considered by the district court, and the record is not sufficiently developed for us to address it for the first time on appeal. We therefore vacate the judgment of non-infringement and remand for the district court for further proceedings consistent with this opinion.

Nova also cross-appeals, arguing that the district court and the jury erred in resolving Nova’s various non-patent counterclaims in Roche’s favor. We hold that the district court did not commit any reversible error, and that the jury verdict is supported by substantial evidence. We thus affirm the district court’s and the jury’s resolution of Nova’s counterclaims.

I. Background

A. Roche’s Infringement Suit

Roche is the owner of U.S. Patent No. 7,276,146 (“'146 patent”) and U.S. Patent No. 7,276,147 (“'147 patent”), (collectively, “patents in suit”). The patents in suit teach methods of determining the concentration of glucose in a blood sample. Roche brought suit in the district court, alleging that Nova’s and Lifescan’s glucose monitoring products (“accused devices”) infringe the patents in suit. Although the patents in suit are directed at methods for measuring glucose, they recite a specific type of electrochemical sensor, also referred to as a “test strip.” The structure and working-mechanism of the glucose sensor are the focus of the parties’ claim construction dispute.

The sensor comprises a capillary chamber and a pair of electrodes. The capillary chamber contains certain enzymes and other chemicals. When blood enters the capillary chamber, the glucose in the blood mixes and reacts with the enzymes. As a result of the reaction, electric charges are released. Meanwhile, using the electrodes, an electric voltage is applied to the glucose-enzyme mixture. The electric charges that are released from the mixture *992 thus flow from one electrode to the other, resulting in an electric current, which can then be measured. The more glucose exists in the blood, the higher the electric current measurement will be. By comparing the current in the test sample with the current in control samples (for which the glucose concentration is already known), the device determines the glucose concentration in the test sample. Claim 1 of the '146 patent is representative and recites,

1. A method of determining the concentration of glucose in a blood sample, comprising;
providing a disposable biosensor test strip including a capillary chamber having a depth suitable for capillary flow of blood and holding a volume of between about 0.1 pi and about 1.0 ¡xl of the blood sample, a working electrode and a counter or reference electrode disposed within the capillary chamber, and a reagent proximal to or in contact with at least the working electrode, the reagent including an enzyme and a mediator, the reagent reacting with glucose to produce an electroactive reaction product; applying a blood sample containing glucose into the capillary chamber, the capillary chamber directing capillary flow of the blood sample into contact with the reagent to cause the blood sample to at least partially solubilize or hydrate the reagent;
detecting the blood sample in the capillary chamber;
following said detecting, applying or controlling the voltage or current across the working and counter or reference electrodes;
electrooxidizing or electroreducing the electroactive reaction product at the working electrode; and within 10 seconds after said detecting, determining and providing a readout of the glucose concentration in the blood sample, said determining comprising correlating the electrooxidized or elect-roreduced electroactive reaction product to the concentration of glucose in the blood sample.

'146 patent col.29 11.38-67 (emphasis added).

Only two claim construction arguments are raised on appeal — one by Roche, and the other by Nova. The first (raised by Roche) concerns the construction of the term “electrode.” 1 Indeed, the district court’s judgment of non-infringement was based solely on the construction of that term, as the district court found that all the other limitations of the asserted patents exist in the accused devices. Initially, at the claim construction stage, Roche argued to the district court that the term “electrode” in the asserted patent claims includes both “micro” and “macro” electrodes. Roche asserted that micro-electrodes are up to approximately 100 jxm wide, whereas macro-electrodes are up to 1,000 p,m wide. Nova and Lifescan agreed with Roche’s characterization of “micro” versus “macro” electrodes, but they contended that Roche’s patent claims only cover micro-electrodes, not macro-electrodes. That is, they argued that the term “electrode” in the patents in suit covers widths up to approximately 100 p,m, but not much more. The district court essentially agreed with Nova and Lifescan and construed the term “electrode” as “microe-lectrode having a width of 15 urn up to approximately 100 pm.” J.A. 3.

The second claim construction dispute *993 pertains to the term “detecting.” 2 Nova and Lifescan argued to the district court that the specification of the patents in suit limits the patent claims by teaching that electric voltage cannot be applied to the working electrode immediately after blood enters the capillary chamber. Rather, according to Nova and Lifescan, the sensor can only measure the electric current in the test sample after a small time-delay (“open circuit delay”), which is necessary to allow the glucose and the chemicals in the capillary chamber to mix well together. Nova and Lifescan argued that because the accused devices do not require an open circuit delay before measuring the glucose concentration, there could be no infringement. The district court rejected this theory, reasoning that it improperly imported a limitation from the specification into the claim terms, which did not expressly require an open circuit delay.

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452 F. App'x 989, Counsel Stack Legal Research, https://law.counselstack.com/opinion/roche-diagnostics-operations-inc-v-lifescan-inc-cafc-2012.