Roche Diagnostics Operations, Inc. et al. v. Lifescan Incorporated et al.
Docket No. 2015-1356
September 22, 2016


Brief Summary: DC grant of SJ of non-infringement to Lifescan based on its construction of the term “electrode” affirmed.

Summary: Roche appealed from DC judgment of non-infringement to Lifescan based on its construction of the term “electrode” in US Pat. Nos. 7,276,146 and 7,276,147 such that the accused products were excluded. Representative claim 1 of the ‘146 patent is directed to “[a] method of determining the concentration of glucose in a blood sample” by “providing a disposable biosensor test strip including a capillary chamber”, “a working electrode and a counter or reference electrode diposed within the capillary chamber, and a reagent [that reacts with glucose] proximal to or in contact with at least the working electrode”. After “detecting the blood sample in the capillary chamber”, “voltage or current” is applied “across the working and counter or reference electrodes” to produce an “electroxidized or electroreduced electroactive product” that is correlated “to the concentration of glucose in the blood sample.” At the Markman hearing, Roche argued the “working electrode” could be of any dimension (e.g., a microelectrode (agreed by the parties to include those up to 100 micrometer in width) or a macroelectrode (300-1000 micrometer)). The DC concluded “the claimed electrodes were limited to microelectrodes [15-100 micrometer] by assertions in the shared specification about ‘the invention’ and arguments during prosecution distinguishing prior art” and entered SJ of non-infringement. This case was remanded in 2012 for the DC to consider Roche’s arguments that “microelectrodes included electrodes up to 1,000 micrometer in width”, which the DC did and affirmed its earlier decision. This appeal followed that decision. Roche argued the DC’s upper size limit was based on a preferred embodiment (RF Del., FC 2003), that it erred in its analysis of diffusion in the claims (i.e., which preclude a 100 micrometer limit), and “‘microelectrode’ has an ordinary meaning of any electrode…up to 1,000 micrometer.” The FC panel disagreed with Roche that the word “especially” at one point in the specification indicated a preferred embodiment and found that the DC properly relied on the section of the shared specification that “defines how a microelectrode can be distinguished from a macroelectrode”. It also disagreed with Roche’s diffusion-related arguments because, e.g., “Roche state[d] that ‘diffusion alone does not provide a clear demarcation of where a microelectrode ends and where a macroelectrode begins.” Roche also argued that “certain examples…show that microelectrodes can have a width greater than 100 micrometer” but the DC found that “while the parties agreed that the term ‘electrode’ was to be construed the same way in both patents, the examples from the ‘146 patent were not included in the ‘147 patent” and “that these examples ‘must be read in light of the microelectrode definition’ in the shared specification” (Sinorgchem, FC 2007 (“Where…multiple embodiments are disclosed, we have previously interpreted claims to exclude embodiments where those embodiments are inconsistent with unambiguous language in the patent’s specification or prosecution history.”)). The FC panel agreed with the DC on this point as well. It also found the DC did not clearly err in finding Roche’s extrinsic evidence regarding the ordinary meaning of microelectrode unpersuasive.

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