Roche Diagnostics Operations v. Lifescan Incorporated

• Court: Court of Appeals for the Federal Circuit
• Decided: September 22, 2016
• Docket: 15-1356
• Status: Unpublished

Opinion

NOTE: This disposition is nonprecedential.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 plain- tiffs-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. 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, Cir- cuit Judges. REYNA, Circuit Judge. Roche Diagnostics Operations, Inc. and Corange In- ternational 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 construc- tion was correct and we therefore affirm the court’s judg- ment 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 con- centration 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 OPERATIONS v. LIFESCAN INC. 3

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 sam- ple, 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 en- zyme and a mediator, the reagent reacting with glucose to produce an electroactive reaction product; applying a blood sample containing glu- cose into the capillary chamber, the capil- lary chamber directing capillary flow of the blood sample into contact with the re- agent 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 con- trolling the voltage or current across the working and counter or reference elec- trodes; electrooxidizing or electroreducing the electroactive reaction product at the work- ing electrode; and within 10 seconds after said detecting, de- termining and providing a readout of the glucose concentration in the blood sample, said determining comprising correlating the electrooxidized or electroreduced elec- troactive reaction product to the concen- tration of glucose in the blood sample. 4 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC.

’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 dimen- sion that provides useful or advantageous results with relatively small samples.” J.A. 14487. Defendants ar- gued 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 elec- trode” 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” includ- ed 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 Diag- nostics 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. ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 5

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 con- ceded 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 reconsid- eration, but said “[i]t’s a great point for the Federal Cir- cuit, 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 argu- ment 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 “elec- trode” 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, 6 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC.

2014 WL 6871579, at *4–6 (D. Del. Dec. 5, 2014) (“Re- mand Op.”). 3 This appeal followed. We have jurisdiction under 28 U.S.C. § 1295(a)(1). DISCUSSION Roche challenges the district court’s claim construc- tion. 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 ap- peared that Roche’s motion for reconsideration had origi- nally been denied on procedural grounds, but that it was uncertain whether Defendants waived procedural chal- lenges to arguments first asserted in Roche’s reconsidera- tion 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 cur- rent 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. ROCHE DIAGNOSTICS OPERATIONS 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 “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 approxi- mately 100 μm.” Remand Op., 2014 WL 6871579, at *6. It interpreted part of the shared specification as indicat- ing “that an electrode might be characterized as a microe- lectrode 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 convert- ing the diffusion characteristic into a size was difficult, and its construction of which electrodes are microelec- trodes 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 deter- mination 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- 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 lim- ited “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 specifi- cation 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 micro- electrode array, especially if the diffusion occurs predomi- nantly (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 para- graph’s final sentence means that this paragraph merely describes a preferred embodiment. We disagree. Roche is correct that a claim term expressed in gen- eral descriptive words typically will not be limited to a

lectrode[] having a width of 15 μm up to approximately 1,000 μm.”). ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 9

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 predomi- nantly 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 macroe- lectrode. See, e.g., Phillips, 415 F.3d at 1315 (The specifi- cation is “the single best guide to the meaning of a disputed term.”). While other parts of the shared specifi- cation 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 dis- cussion of diffusion precludes a 100 μm limit for microe- lectrode 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 10 ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC.

the shared specification’s discussion of diffusion than any other width limit. We disagree that the shared specifica- tion’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 elec- trodes in these examples as microelectrodes, Roche as- serts that an inventor declaration filed during the prosecution of the patents identified electrodes that either are the same electrodes or are “similar to” these elec- trodes 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 con- strued 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 ex- clude embodiments where those embodiments are incon- sistent 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 defini- tional paragraph discussed above. Finding these elec- trodes to be microelectrodes would be inconsistent with the shared specification’s explanation that the microelec- trodes cause diffusion “in a non-planar fashion,” and that, where electrodes “cause diffusion to take place by a mix of ROCHE DIAGNOSTICS OPERATIONS v. LIFESCAN INC. 11

planar and non-planar paths,” electrodes will be consid- ered 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 indica- tions 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 capil- lary 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, inter- sti[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 inter- preting these ’146 examples as microelectrodes would be 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 demon- strates 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 unpersua- sive, 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 Tech- nology, 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 ROCHE DIAGNOSTICS OPERATIONS 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 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 ap- proximately 100 μm.” AFFIRMED COSTS Costs to Defendants.