N OTE : This disposition is nonprecedential. 

# United States **Court of Appeals**  **for the Federal Circuit**

______________________
ROCHE DIAGNOSTICS OP ERATIONS, INC., CORANGE INTERNATIONA L LIMITED, Plaintiffs

- Appellants

v.

LIFESCAN INCORPORATE D, 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

______________________
G RANTLAND G ILBERT D RUTCHAS , McDonnell, Boehnen, Hulbert & Berghoff, LLP, Chicago, IL, argued for plai ntiffs

- appellants. Also represented by P AULA F RITSCH

.

W ILLIAM C. R OOKLIDGE , Gibson, Dunn & Crutcher LLP, Irvine, CA, argued for defendant -appellee Lifescan Incorporated. Also represented by J AYSEN C HUNG , San Francisco, CA.ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 2

B RADFORD J. B ADKE , Sidley Austin LLP , New York, NY, argued for defendant

- appellee Nova Biomedical Corporation. Also represented by S ONA D E

.

______________________
Before P ROST , Chief Judge, M AYER , and R EYNA , Ci rcuit Judges.

R EYNA , Circuit Judge

. Roche Diagnostics Operations, Inc. and Corang e I nternational 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. T he district court’s claim constru ction was c orrect and we therefore affirm the court’s jud gment of non -infringement.

B ACKGROUND

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 co ncentration 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.”ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 3

providing a disposable biosensor test strip including a capillary chamber having a depth suitable for capillary flow of blood and holdin g a volume of between about 0.1 μ l and about 1.0 μ l of the blood sa mple, 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 e nzyme and a mediator, the reagent reacting with glucose to produce an electroactive reaction product;
applying a blood sample containing gl ucose into the capillary chamber, th e capi llary chamber directing capillary flow of the blood sample into contact with the r eagent 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 co ntrolling the voltage or current across the working and counter or reference ele ctrodes;
electrooxidizing or electroreducing the electroactive reaction product at the wor king electrode; and
within 10 seconds after said detecting, d etermining and providing a readout of the glucose concentration in the blood sample, said determining comprising correlating the electrooxidized or electroreduced ele ctroactive reaction product to the conce ntration of glucose in the blood sample.ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 4

’146 patent col. 29 ll. 38

– 67. II. Procedural History
Roche sued Defendants for infringement of the ’ 146 and ’147 patent s

. T he parties disagree d about the proper construction of certain claim limitations that includ ed the term “elec trode.” 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. Roch e argued that the claimed electrodes “may be of any dime nsion that provides useful or advantageous results with relatively small samples.” J. A

. 14487. Defendants a rgued that the term “electrode” should be construed as “microelectrode having a width of 15 to 100 μ m.” 2 J. A

. 12. For example, Defendants proposed that “working ele ctrode” should be construed as “[a] working microelectrode having a width of 15 to 100 μ m.” Id.

At a Markman hearing , Roche opposed Defendants’ “electrode” construction s, alleging that “electrode” inclu ded not only microelectrodes but also macroelectrodes. Roche argued that the term “electrode” included certain electrodes with widths from 300 to 1,000 μ m, which Roche asserted were macroelectrodes, not microelectrodes

. Roche did not dispute that microelectrodes only included electrodes up to 100 μ m in width.

The d istrict c ourt 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 μ m, the abbreviation for micrometer, which is a millionth of a meter and is also referred to as a micron.ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 5

Supp. 2d 429, 435 (D. Del. 2009). I t construed “electrode”
to mean “microelectrode having a width of 15 μ m up to approximately 100 μ m.” Id. at 4 42

– 43.

Roche moved for reconsideration. While Roche co nceded that the claim term “electrode” did not include macroelectrodes, Roche argued that microelectrodes included electrodes up to 1

, 000 μ m in width.

The d istrict c ourt denied Roche’s motion for r econsi deration, but said “[i]t’s a great point for the Federal Ci rcuit, and I actually think you might have a point. But it will be interesting to see what they say.” J. A

. 35. T he court entered summary judgment of non -infringement on the basis that Defe ndants’ products contain electrodes larger than 100 μ m.
Roche appealed to this court and repeated the arg ument it had first raised in its motion for reconsideration: it asserted that microelectrodes included electrodes up to 1, 000 μ m in width

. Roche Diagnostics Operations, Inc. v. Lifescan Inc. , 452 F. App’x 989, 994

– 95 (Fed. Cir. 2012) ( Roche I )

. Defendants oppos ed Roche’s arguments, but did not challenge whether the se argument s were properly before the court

. Id. at 994

– 97

. As the district court had not previously addressed the parties’ arguments regarding 1

, 000 μ m 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 “ele ctrode” meant “ microelectrode having a width of 15 μ m up to approximately 100 μ m. ” Roche Diagnostics Operations, Inc. v. Abbott Diabetes Care, Inc. , No. CV 07

- 753

- RGA,ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 6

2014 WL 6871579, at * 4–6 (D. Del. Dec. 5, 2014) (“ R emand Op. ”). 3
This appeal followed. We have jurisdiction un der 28 U.S.C. § 1295(a)(1).

D ISCUSSION Roche challenges the district court’s claim constru ction. 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 pr eviously, 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. T he district court judge stated that it a ppeared that Roche’s motion for reconsideration had originally been denied on proce dural grounds, but that it was uncertain whether Defendants waived procedural cha llenges to arguments first asserted in Roche’s reconsider ation motion by not raisin g them before this court on appeal. Remand Op.

, 2014 WL 6871579, at *3 –4. On appeal now, Defendants contend that Roche ’s cu rrent claim construction arguments
, which are premised

on microelectrodes includ ing electrodes up to 1000 μ m in width, are proc edur a lly 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 challenge s 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 c ourt’s claim construction even when we consider Roche’s argu ments

.ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 7

about extrinsic evidence that underlie its construction, we review the factual findings for clear error. Id. at 842. Claim terms are “general ly given their ordi nary 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 μ m up to approx imately 100 μ m.” Remand Op.

, 2014 WL 6871579, at *6. It interpreted part of the shared specification as indica ting “that an electrode might be characterized as a micro electrode 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 μ m.” 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 conver ting the diffusion characteristic into a size was difficult

, and its construction of wh ich electrode s are microele ctrode s relied on the 100 μ m width description. Id. at *5.
The only aspect of the district court’s construction of “e lectrode” that Roche challenges on appeal is the upper width limit of “ up to approximately 100 μ m .” 4 Roche

4 Roche does not appeal the district court’s dete rmination that Roche disclaimed macroelectrodes during the patents’ prosecution. Roche also does not dispute that the claimed microelectrodes should be distinguished from macroelectro des on the basis of their width or that the lower limit for width should be 15 μ m

. See Roche Br. 62 (arguing that “ele ctrode” should be construed as “ micro e-ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 8

argues that the claimed electrodes in clude electrodes up to 1
, 000 μ m

. 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

an y electrod e measu red in micrometers or μm , up to 1, 00 0 μm

. We address these arguments in turn.

I
According to Roche

, the district court improperly li mited “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 c onfigurations can cause diffusion to take place by a mix of planar and non

- planar paths, in which case the electrodes can be considered a micro

electrode array, especially if the diffusion occurs predom inantly (e.g., greater than 50%) according to a non

- pl anar path, or if the size of the electrodes is less than 100 μ m, e.g., less than 50 μ m. ” See, e.g.

, ’146 patent col. 4 ll. 42

– 48 (emphasis add ed).
Roche argues that the word “especially” in the par agraph’s final sentence means that this paragraph merely describes a preferred embodiment. We disagree.

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

lectrode[] having a width of 15 μ m up to approximately 1,000 μ m.” ).ROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 9

numerical range described in the written descrip tion as referring to a pre ferred 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 paragr aph distinguishes microelectrodes from macroelectrodes based on the type of diffusion they cause

. A n electrode that causes “a mix of planar and non

- planar ” diffusion will be considered a microelectrode especially when the diffusion is predom inantly nonpla nar or the electrode’s size is less than 100

μ m. ’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 th e language it cited defines how a microelectrode can be distinguished from a macro electrode. 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 μ m a s 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 di scussion of diffusion precludes a 100 μ m limit for micro electrode width. However, Roche state s that “ diffusion alone does not provide a clear demarcation of where a microelectrode ends and where a macroelectrode begins.” Roche B r. 41. Roche also admit s 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 μ m width limit is more consistent withROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 10

the shared specification ’ s discussion of diffusion than any other width limit. We disagree that the shared specific ation’s discussion of diffusion precludes a 100 μ m limit.

III
Roche further argues that certain examples in the ’146 patent show that microelectrode s can have a width greater than 100 μ m

. E xamples 3, 4, and 5 of the ’146 patent disclose electrodes that are wider than 100 μ m

. While the ’146 specification do es not identify the ele ctrodes in these examples as mi croelectrodes, Roche a sserts that an inventor declaration filed during the prosecution of the patents identified electrodes that either are the same electrodes or are “similar to” these ele ctrodes as being microelectrodes. Roche Br. 11 , 42

– 43.
On remand, t he district court noted that, while the parties agreed that the term “electrode” was to be co nstrued 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 Commissio n , 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 e xclude embodiments where those embodiments are inco nsistent 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 defin itional paragraph discussed above. F inding these ele ctrodes to be microelectrodes would be inco nsistent with the shared specification ’ s explanation that the microele ctrodes cause diffusion “ in a non

- planar fashion,” and that, where electrodes “cause diffusion to take place by a mix ofROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 11

planar and non

- planar paths,” electrodes will be consi dered microelectrodes when the diffusion is predominantly “according to a non

- planar path” or “if the size of the electrodes is less than 100 μ m.” ’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 μ m.
This determination is consistent with other indic ations 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; F igs. 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 capi llary chamber having a d epth 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 μ m, but the shared specification suggests that a capillary depth of at least 100 μ m is needed for blood:
Capillaries with depths of greater than or equal to 100 μ m 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 u sed for other biological fluids such as serum, plasma, inte rsti[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 inte rpreting these ’146 examples as microelectrodes would beROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 12

inc onsistent 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 μ m. 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 μ m

— wa s not enabled, and whether it was invalid for lack of written description.

IV
Finally, Roche argues that extrinsic evidence demo nstrates that the ordinary meaning of microelectrode is any electrode measured in micrometers, up to 1, 00 0 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 extrinsi c sources do not demonstrate that microelectrode ha s an ordinary meaning of any electrode measured in micrometers, up to 1, 00 0 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 Tec hnology , 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 D efendants note, th e encyclopedia cites 15 R. Mark Wight man and David O. Wipf, Voltammetry at Ultramicroelectrodes (1989) as support for this statement. That article, prov ided by Defendants, states that “[t] he term ‘microelectrode’ isROCHE DIAGNOSTICS OP ERATIONS v. LIFESCAN INC

. 13

already in routine use for electrodes with dimensions approaching a centimeter or greater,” which is ten times larger than the 1,000 μ m limit Roche proposes. J. A

. 28261. Th e article further states that “[t]his area is still sufficiently new that a unifor m 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.

C ONCLUSION

W e affirm the district court’s con struction of electrode as a “microelectrode having a width of 15 μ m up to a pproximately 100 μ m.”

AFFIRMED

C OSTS
Costs to Defendants.