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Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 

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NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________ 

ROCHE DIAGNOSTICS OPERATIONS, INC., 

CORANGE INTERNATIONAL LIMITED,

Plaintiffs-Appellants

v.

LIFESCAN INCORPORATED, NOVA BIOMEDICAL 

CORPORATION,

Defendants-Appellees

______________________ 

2015-1356

______________________ 

Appeal from the United States District Court for the 

District of Delaware in No. 1:07-cv-00753-RGA, Judge 

Richard G. Andrews.

______________________ 

Decided: September 22, 2016

______________________ 

GRANTLAND GILBERT DRUTCHAS, McDonnell, Boehnen, 

Hulbert & Berghoff, LLP, Chicago, IL, argued for plaintiffs-appellants. Also represented by PAULA FRITSCH. 

WILLIAM C. ROOKLIDGE, Gibson, Dunn & Crutcher 

LLP, Irvine, CA, argued for defendant-appellee Lifescan 

Incorporated. Also represented by JAYSEN CHUNG, San 

Francisco, CA.

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2 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 

BRADFORD J. BADKE, Sidley Austin LLP, New York, 

NY, argued for defendant-appellee Nova Biomedical 

Corporation. Also represented by SONA DE. 

______________________ 

Before PROST, Chief Judge, MAYER, and REYNA, Circuit Judges.

REYNA, Circuit Judge. 

Roche Diagnostics Operations, Inc. and Corange International Limited (“Roche”) appeal from the United 

States District Court for the District of Delaware’s grant 

of summary judgment in favor of Lifescan Incorporated 

and Nova Biomedical Corporation (“Defendants”). The 

district court entered judgment of non-infringement after 

construing the term “electrode” in a way that excluded 

Defendants’ products. The district court’s claim construction was correct and we therefore affirm the court’s judgment of non-infringement. 

BACKGROUND

I. Patents

This case involves U.S. Patent Nos. 7,276,146 (“’146 

patent”) and 7,276,147 (“’147 patent”). Both patents claim 

priority to the same provisional application and have 

similar specifications.1 

The patents claim methods for determining the concentration of glucose in a blood sample. Claim 1 of the 

’146 patent is representative of the asserted claims:

1. A method of determining the concentration of 

glucose in a blood sample, comprising;

1 This opinion refers to the specification portions 

shared by both patents as the “shared specification.”

 

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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 μl and about 1.0 μl 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 electroreduced electroactive reaction product to the concentration of glucose in the blood sample.

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’146 patent col. 29 ll. 38–67. 

II. Procedural History

Roche sued Defendants for infringement of the ’146 

and ’147 patents. The parties disagreed about the proper 

construction of certain claim limitations that included the 

term “electrode.” Roche initially proposed constructions 

describing the function of particular electrodes. For 

example, it argued that “working electrode” should be 

construed as “[a]n electrode in an electrochemical cell at 

which the reaction of interest occurs.” J.A. 12. Roche 

argued that the claimed electrodes “may be of any dimension that provides useful or advantageous results with 

relatively small samples.” J.A. 14487. Defendants argued that the term “electrode” should be construed as 

“microelectrode having a width of 15 to 100 μm.”2 J.A. 12. 

For example, Defendants proposed that “working electrode” should be construed as “[a] working microelectrode 

having a width of 15 to 100 μm.” Id.

At a Markman hearing, Roche opposed Defendants’ 

“electrode” constructions, alleging that “electrode” included not only microelectrodes but also macroelectrodes. 

Roche argued that the term “electrode” included certain

electrodes with widths from 300 to 1,000 μm, which Roche 

asserted were macroelectrodes, not microelectrodes. 

Roche did not dispute that microelectrodes only included 

electrodes up to 100 μm in width.

The district court found that the claimed electrodes 

were limited to microelectrodes by assertions in the 

shared specification about “the invention” and arguments

during prosecution distinguishing prior art. Roche Diagnostics Operations, Inc. v. Abbott Diabetes Care, 667 F.

2 The unit of measurement is μm, the abbreviation 

for micrometer, which is a millionth of a meter and is also 

referred to as a micron.

 

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Supp. 2d 429, 435 (D. Del. 2009). It construed “electrode” 

to mean “microelectrode having a width of 15 μm up to 

approximately 100 μm.” Id. at 442–43.

Roche moved for reconsideration. While Roche conceded that the claim term “electrode” did not include

macroelectrodes, Roche argued that microelectrodes 

included electrodes up to 1,000 μm in width.

The district court denied Roche’s motion for reconsideration, but said “[i]t’s a great point for the Federal Circuit, and I actually think you might have a point. But it 

will be interesting to see what they say.” J.A. 35. The 

court entered summary judgment of non-infringement on 

the basis that Defendants’ products contain electrodes 

larger than 100 μm. 

Roche appealed to this court and repeated the argument it had first raised in its motion for reconsideration: 

it asserted that microelectrodes included electrodes up to 

1,000 μm in width. Roche Diagnostics Operations, Inc. v. 

Lifescan Inc., 452 F. App’x 989, 994–95 (Fed. Cir. 2012)

(Roche I). Defendants opposed Roche’s arguments, but 

did not challenge whether these arguments were properly 

before the court. Id. at 994–97. 

As the district court had not previously addressed the 

parties’ arguments regarding 1,000 μm microelectrodes, 

we declined to address them and remanded so that the 

district court could consider them in the first instance. 

Id. 

On remand, the district court considered the parties’ 

arguments and affirmed its earlier decision that “electrode” meant “microelectrode having a width of 15 μm up 

to approximately 100 μm.” Roche Diagnostics Operations, 

Inc. v. Abbott Diabetes Care, Inc., No. CV 07-753-RGA, 

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6 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 

2014 WL 6871579, at *4–6 (D. Del. Dec. 5, 2014) (“Remand Op.”).3

This appeal followed. We have jurisdiction under 28 

U.S.C. § 1295(a)(1).

DISCUSSION

Roche challenges the district court’s claim construction. We review a district court’s claim construction de 

novo. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 

831, 841 (2015). If a district court makes factual findings 

3 On appeal previously, this court noted uncertainty 

as to whether Roche’s motion for reconsideration was 

procedurally appropriate. Roche I, 452 F. App’x at 994. 

On remand, the case was assigned to a different district 

court judge. The district court judge stated that it appeared that Roche’s motion for reconsideration had originally been denied on procedural grounds, but that it was 

uncertain whether Defendants waived procedural challenges to arguments first asserted in Roche’s reconsideration motion by not raising them before this court on 

appeal. Remand Op., 2014 WL 6871579, at *3–4. 

On appeal now, Defendants contend that Roche’s current claim construction arguments, which are premised 

on microelectrodes including electrodes up to 1000 μm in 

width, are procedurally barred because they were first 

raised in Roche’s reconsideration motion, and Roche did 

not appeal the district court’s denial of that motion in the 

prior appeal. Roche asserts that Defendants have waived 

procedural challenges to these arguments by not raising 

them when this case was previously on appeal. Roche 

also argues that the district court erred in applying the 

Third Circuit’s standards for motions for reconsideration. 

We need not address these procedural issues, because 

we affirm the district court’s claim construction even 

when we consider Roche’s arguments. 

 

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about extrinsic evidence that underlie its construction, we 

review the factual findings for clear error. Id. at 842.

Claim terms are “generally given their ordinary and 

customary meaning.” Phillips v. AWH Corp., 415 F.3d 

1303, 1312–13 (Fed. Cir. 2005) (quoting Vitronics Corp. v. 

Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). A 

term’s ordinary meaning is “its meaning to the ordinary

artisan after reading the entire patent.” Id. at 1321. A 

specification may define claim terms expressly or by 

implication. Id. at 1320–21.

The district court construed “electrode” to mean a 

“microelectrode having a width of 15 μm up to approximately 100 μm.” Remand Op., 2014 WL 6871579, at *6. 

It interpreted part of the shared specification as indicating “that an electrode might be characterized as a microelectrode in one of two situations: (1) where there is 

greater than 50% non-planar diffusion, or (2) where the 

electrode has a width less than 100 μm.” Id. at *4–5 

(referencing ’146 patent col. 4 ll. 29–48 and ’147 patent 

col. 4 ll. 10–29). The district court explained that converting the diffusion characteristic into a size was difficult, 

and its construction of which electrodes are microelectrodes relied on the 100 μm width description. Id. at *5. 

The only aspect of the district court’s construction of 

“electrode” that Roche challenges on appeal is the upper 

width limit of “up to approximately 100 μm.”4 Roche 

4 Roche does not appeal the district court’s determination that Roche disclaimed macroelectrodes during 

the patents’ prosecution. Roche also does not dispute that 

the claimed microelectrodes should be distinguished from 

macroelectrodes on the basis of their width or that the 

lower limit for width should be 15 μm. See Roche Br. 62 

(arguing that “electrode” should be construed as “microe-

 

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8 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 

argues that the claimed electrodes include electrodes up 

to 1,000 μm. Defendants disagree. 

Roche presents several arguments why the district 

court improperly construed “electrode.” First, Roche 

argues that the district court based the construction on a 

width the shared specification describes as a preferred 

embodiment. Second, Roche asserts that the district court 

erred in its analysis of diffusion, examples 3–5 of the ’146 

patent, and claim 48 of the ’146 patent. Finally, Roche 

claims that “microelectrode” has an ordinary meaning of

any electrode measured in micrometers or μm, up to 

1,000 μm. We address these arguments in turn.

I 

According to Roche, the district court improperly limited “electrode” based on a width the shared specification 

describes as a preferred embodiment. The district court’s 

construction was based on a portion of the shared specification which stated, in part, that “[i]t is also understood 

that some electrode configurations can cause diffusion to 

take place by a mix of planar and non-planar paths, in 

which case the electrodes can be considered a microelectrode array, especially if the diffusion occurs predominantly (e.g., greater than 50%) according to a non-planar 

path, or if the size of the electrodes is less than 100 μm, 

e.g., less than 50 μm.” See, e.g., ’146 patent col. 4 ll. 42–48

(emphasis added). 

Roche argues that the word “especially” in the paragraph’s final sentence means that this paragraph merely 

describes a preferred embodiment. We disagree. 

Roche is correct that a claim term expressed in general descriptive words typically will not be limited to a 

lectrode[] having a width of 15 μm up to approximately 

1,000 μm.”).

 

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numerical range described in the written description as 

referring to a preferred embodiment. RF Del., Inc. v. Pac. 

Keystone Techs., Inc., 326 F.3d 1255, 1263 (Fed. Cir. 

2003). But the paragraph the district court’s construction 

relies on includes the only mention of macroelectrodes in 

either patent’s specification. The paragraph distinguishes 

microelectrodes from macroelectrodes based on the type of

diffusion they cause. An electrode that causes “a mix of 

planar and non-planar” diffusion will be considered a 

microelectrode especially when the diffusion is predominantly nonplanar or the electrode’s size is less than 100 

μm. ’146 patent col. 4 ll. 42–48; ’147 patent col. 4 ll. 23–

29. 

Considering the specifications as a whole, we agree 

with the district court that the language it cited defines 

how a microelectrode can be distinguished from a macroelectrode. See, e.g., Phillips, 415 F.3d at 1315 (The specification is “the single best guide to the meaning of a 

disputed term.”). While other parts of the shared specification refer to various widths including 100 μm as being 

“preferred,” see, e.g., ’146 patent col. 3 ll. 9–12, this does 

not prevent the portion of the shared specification that 

the district court’s interpretation relied on from providing 

a definition of microelectrodes.

II

Roche also argues that the shared specification’s discussion of diffusion precludes a 100 μm limit for microelectrode width. However, Roche states that “diffusion 

alone does not provide a clear demarcation of where a 

microelectrode ends and where a macroelectrode begins.” 

Roche Br. 41. Roche also admits that “diffusion simply 

depends on far too many variables to be limited to any 

particular size electrode.” Remand Op., 2014 WL 

6871579, at *5.

Roche fails to provide a persuasive rationale for why 

its proposed 1,000 μm width limit is more consistent with

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the shared specification’s discussion of diffusion than any 

other width limit. We disagree that the shared specification’s discussion of diffusion precludes a 100 μm limit. 

III

Roche further argues that certain examples in the 

’146 patent show that microelectrodes can have a width 

greater than 100 μm. Examples 3, 4, and 5 of the ’146 

patent disclose electrodes that are wider than 100 μm. 

While the ’146 specification does not identify the electrodes in these examples as microelectrodes, Roche asserts that an inventor declaration filed during the 

prosecution of the patents identified electrodes that either 

are the same electrodes or are “similar to” these electrodes as being microelectrodes. Roche Br. 11, 42–43. 

On remand, the district court noted that, while the 

parties agreed that the term “electrode” was to be construed the same way for both patents, the examples from 

the ’146 patent were not included in the ’147 patent. 

Remand Op., 2014 WL 6871579, at *5. The district court 

decided that these examples “must be read in light of the 

microelectrode definition” in the shared specification. Id. 

For this principle, the district court cited Sinorgchem Co., 

Shandong v. International Trade Commission, 511 F.3d 

1132, 1138 (Fed. Cir. 2007), and quoted Sinorgchem’s

statement that “[w]here . . . 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.” Id.

We agree with the district court’s decision not to 

adopt a construction that is inconsistent with the definitional paragraph discussed above. Finding these electrodes to be microelectrodes would be inconsistent with 

the shared specification’s explanation that the microelectrodes cause diffusion “in a non-planar fashion,” and that, 

where electrodes “cause diffusion to take place by a mix of 

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planar and non-planar paths,” electrodes will be considered microelectrodes when the diffusion is predominantly 

“according to a non-planar path” or “if the size of the 

electrodes is less than 100 μm.” ’146 patent col. 4 ll. 42–

48; ’147 patent col. 4 ll. 23–29. As a result, we find that 

these examples are unclaimed embodiments because they 

include electrodes larger than 100 μm.

This determination is consistent with other indications that examples 3–5 of the ’146 patent are unclaimed 

embodiments. For example, the patents’ claims are 

limited to methods testing blood samples, while the

examples disclose embodiments that were evaluated 

testing saline, which is not blood. ’146 patent at col. 26 ll. 

10–col. 28 ll. 51; Figs. 10–12. Although Roche claims that 

the embodiments disclosed in the examples could be used 

with blood, the shared specification includes language 

suggesting that these embodiments could only be used for 

body fluids other than blood, such as serum or plasma. 

Specifically, all of the independent claims recite “a capillary chamber having a depth suitable for capillary flow of 

blood.” See, e.g., ’146 patent col. 29 ll. 42–43. Examples 

3–5 in the ’146 patent disclose embodiments having

capillary depths of 62 μm, but the shared specification 

suggests that a capillary depth of at least 100 μm is

needed for blood:

Capillaries with depths of greater than or equal to 

100 μm have been found to allow fast fill of blood 

with hematocrits from 20 to 70% to reliably flow 

into the chamber. Capillary depths of less than 

100 microns to 25 microns can be used for other 

biological fluids such as serum, plasma, intersti[t]ial fluid, and the like.

’146 patent col. 19 ll. 45–50; ’147 patent col. 18 ll. 27–32 

(emphasis added).

Because we agree with the district court that interpreting these ’146 examples as microelectrodes would be 

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12 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 

inconsistent with the shared specification’s disclosure 

distinguishing macroelectrodes from microelectrodes, we 

need not decide whether the patents’ claimed “depth 

suitable for capillary flow of blood” includes depths less 

than 100 μm. Therefore, we also need not address the 

district court’s related determination that dependent 

claim 48 of the ’146 patent—which claims depths below 

100 μm—was not enabled, and whether it was invalid for 

lack of written description.

IV 

Finally, Roche argues that extrinsic evidence demonstrates that the ordinary meaning of microelectrode is any 

electrode measured in micrometers, up to 1,000 μm. The 

district court found this extrinsic evidence was unpersuasive, and that it did not “trump the intrinsic evidence.” 

Remand Op., 2014 WL 6871579, at *6. To the extent that 

this is a factual finding, we review it for clear error.

We find that the court did not clearly err in finding 

Roche’s extrinsic evidence unpersuasive. In fact, Roche’s 

extrinsic sources do not demonstrate that microelectrode 

has an ordinary meaning of any electrode measured in 

micrometers, up to 1,000 μm. For example, one of the 

sources Roche cites is the Kirk-Othmer Encyclopedia of 

Chemical Technology. This encyclopedia states that 

“[s]mall, referring to the diameter of the electrode, is 

about a millimeter for microelectrodes.” 9 Raymond E. 

Kirk et al., Kirk-Othmer Encyclopedia of Chemical Technology, 97, 4th ed. (1994). This statement arguably 

supports Roche’s proposed construction, as it mentions

1,000 μm microelectrodes. (1 millimeter is equal to 1,000 

μm.) However, it appears to declare that a 1,000 μm 

electrode is a small microelectrode. As Defendants note,

the encyclopedia cites 15 R. Mark Wightman and David

O. Wipf, Voltammetry at Ultramicroelectrodes (1989) as 

support for this statement. That article, provided by 

Defendants, states that “[t]he term ‘microelectrode’ is 

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already in routine use for electrodes with dimensions 

approaching a centimeter or greater,” which is ten times 

larger than the 1,000 μm limit Roche proposes. J.A. 

28261. The article further states that “[t]his area is still 

sufficiently new that a uniform nomenclature for these 

electrodes has not yet been developed.” Id. Even the 

extrinsic evidence Roche cited is inconsistent with its 

assertion that 1,000 μm is an established width limit for 

microelectrodes.

CONCLUSION

We affirm the district court’s construction of electrode 

as a “microelectrode having a width of 15 μm up to approximately 100 μm.”

AFFIRMED

COSTS

Costs to Defendants.

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