Citations
- 186 F. Supp. 2d 914
Full opinion text
CORRECTED ORDER ON CLAIM CONSTRUCTION
McKINNEY, Chief Judge.
This cause is now before the Court following a hearing held to assist the Court with construction of the claim language of the patent at issue in this infringement suit, U.S. Patent Reissue No. 36,268 (“'268 patent”). Guided by the Supreme Court’s opinion in Markman v. Westview Inst, Inc., 517 U.S. 370, 388-90, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996) (“Markman IF), and by the Federal Circuit’s opinion in Markman v. Westview Inst, Inc., 52 F.3d 967 (Fed.Cir.1995) (“Markman F), the claim construction rendered herein will not be a “tentative one” subject to change upon receipt of additional information and evidence, but a definitive one based on all of the evidence of record at this point in the litigation. See International Comm. Mat’ls, Inc. v. Ricoh Co., Ltd., 108 F.3d 316, 318-19 (Fed.Cir.1997) (noting that district court performed a “tentative construction” of the claim language to facilitate a decision of the preliminary injunction issue). Having been fully advised by the parties of their relative positions, the Court will discuss the relevant legal rules and application of those rules to the patent in dispute.
I. CLAIM CONSTRUCTION STANDARDS
When construing the '268 patent’s claims, the Court must determine the meaning of the language used before it can ascertain the scope of the claims Roche alleges are being infringed. See Markman I, 52 F.3d at 979. In doing so, the Court’s interpretive focus is not the subjective intent of the parties employing a certain term, but the objective test of what one of ordinary skill in the art at the time of the invention would havp understood the term to mean. See id. at 986. When the Court undertakes its duty to construe the claims, it first must look to the intrinsic evidence: the asserted and unasserted claims, the specification, and the prosecution history. See Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1366 (Fed.Cir.2001); Watts v. XL Sys. Inc., 232 F.3d 877, 882 (Fed.Cir.2000); Desper Prods. Inc. v. QSound Labs, Inc., 157 F.3d 1325, 1333 (Fed.Cir.1998) (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1581 (Fed.Cir.1996)); Markman I, 52 F.3d at 979. Most of the time, such evidence will provide sufficient information for construing the claims. See Vitronics, 90 F.3d at 1583.
The patent claims should “ ‘particularly point out and distinctly clai[m] the subject matter which the applicant regards as his invention.’ ” Markman II, 517 U.S. at 373, 116 S.Ct. 1384 (citing 35 U.S.C. § 112). During claim construction, the appropriate starting point for the court’s inquiry is always the words of both the asserted and unasserted claims. See Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 977 (Fed.Cir.1999); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed.Cir.1999); Comark Comms., Inc. v. Harris Corp., 156 F.3d 1182, 1186 (Fed.Cir.1998); Vitronics, 90 F.3d at 1582; see also Renishaw PLC v. Marposs Societa’ Per Azioni, 158 F.3d 1243,1248 (Fed.Cir.1998). It is the claims, not the written description, that define the scope of the patent and accordingly, the patentee’s rights. See Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1347 (Fed.Cir.1998); Markman I, 52 F.3d at 970-71. As the Federal Circuit has recently noted, “[c]ommon words, unless the context suggest otherwise, should be interpreted according to their ordinary meaning.” Desper Prods., 157 F.3d at 1336 (citing York Prods., Inc. v. Central Tractor Farm & Family Ctr., 99 F.3d 1568, 1572 (Fed.Cir.1996)). See also Ecolab, 264 F.3d at 1366; Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed.Cir.1999); Renishaw, 158 F.3d at 1249. Further, when there are several common meanings for a term, “the patent disclosure serves to point away from the improper meanings and toward the proper meaning.” Renishaw, 158 F.3d at 1250. Accord Desper Prods., 157 F.3d at 1336 (stating that the context of the claims can be found in the specification and drawings).
A claim term will not be given a common dictionary meaning, however, if such a reading would be nonsensical in light of the patent disclosure, or specification. See Renishaw, 158 F.3d at 1250. Accordingly, the correct claim construction is also the one that “stays true to the claim language and most naturally aligns with the patent’s description of the invention.” Id. That description, or specification, serves an important purpose. In it, the patentee must provide a written description of the invention that would allow a person of ordinary skill in the art to make and use the invention. See Markman I, 52 F.3d at 979. The applicable statute requires that “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains ... to make and use the same.... ” 35 U.S.C. § ¶ 112, ¶ 1. See also Johnson Worldwide Assocs., 175 F.3d at 993. Therefore, to discover the correct meaning of a disputed claim term, the court must refer to the specification’s description of the invention.
In addition, a patentee may be his or her own lexicographer and use terms in a manner different from their ordinary meaning. See Johnson Worldwide Assocs., 175 F.3d at 990; Vitronics, 90 F.3d at 1582. If the patentee chooses to do that, he or she must clearly state the special definition in the specification or file history of the patent. See id. The specification then serves as a dictionary when it defines terms, either expressly or by implication, that are used in the claims. See id. Therefore, it is also important to review the specification to discern whether the patentee has used a term in a way that is inconsistent with its ordinary meaning. See id. However, the specification should be used to clarify unclear claim terms, not to “trump the clear meaning of a claim term.” Comark, 156 F.3d at 1187 (citing E.I. du Pont de Nemours & Co. v. Phillips Petroleum, 849 F.2d 1430, 1433 (Fed.Cir.1988)).
Claims must be read in light of the specification. See Markman I, 52 F.3d at 979. However, limitations from the specification may not be read into the claims. See Comark, 156 F.3d at 1186; see also Laitram, 163 F.3d at 1347. In particular, the court should not limit the invention to the specific examples or preferred embodiment found in the specification. See Texas Instruments, Inc. v. United States Int’l Trade Comm’n, 805 F.2d 1558, 1563 (Fed.Cir.1986); see also Co-mark, 156 F.3d at 1186. Therefore, the “repetition in the written description of a preferred aspect of a claim invention does not limit the scope of an invention that is described in the claims in different and broader terms.” Laitram, 163 F.3d at 1348. See also Electro Med. Sys. v. Cooper Life Sciences, Inc., 34 F.3d 1048, 1054 (Fed.Cir.1994).
Interpreting the meaning of a claim term “is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.” Laitram, 163 F.3d at 1348 (quoting Intervet Am., Inc. v. Kee-Vet Lab., Inc., 887 F.2d 1050, 1053 (Fed.Cir.1989)). An extraneous limitation is a limitation added “wholly apart from any need to interpret what the patentee meant by particular words and phrases in the claim.” Hoganas AB v. Dresser Indus., Inc., 9 F.3d 948, 950 (Fed. Cir.1993). See also Renishaw, 158 F.3d at 1249. Although there is a fine line between reading a claim in light of the specification and reading a limitation from the specification into the claim, the court must look cautiously to the specification for assistance in defining unclear terms. See Watts, 232 F.3d at 882; Comark, 156 F.3d at 1186-87.
The third source of intrinsic evidence is the patent’s prosecution history. See Desper Prods., 157 F.3d at 1336-37; Vitronics, 90 F.3d at 1582. “Prosecution history is an important source of intrinsic evidence in interpreting claims because it is a contemporaneous exchange between the applicant and the examiner.” Desper Prods., 157 F.3d at 1336-37. In a patent’s prosecution history the court will find a complete record of the proceedings before the PTO leading to issuance of the patent. See Vitronics, 90 F.3d at 1582. The prosecution history contains both express representations made by the patentee concerning the scope of the patent, as well as interpretations of claim terms that were disclaimed during the prosecution. See id. at 1582-83; see also Ecolab, 264 F.3d at 1368; Elkay Mfg., 192 F.3d at 978; Southwall Tech. Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed.Cir.), cert. denied, 516 U.S. 987, 116 S.Ct. 515, 133 L.Ed.2d 424 (1995). Although the prosecution history is useful for understanding claim language, it “cannot enlarge, diminish, or vary the limitations in the claims.” Markman I, 52 F.3d at 979 (quotations omitted).
In some cases, it may be necessary for the court to consult extrinsic evidence to aid it in construing the claim language. See Pitney Bowes, 182 F.3d at 1308; Vitronics, 90 F.3d at 1584. Extrinsic evidence is any evidence outside of the patent and prosecution history, “including expert and inventor testimony, dictionaries, and learned treatises.” Markman I, 52 F.3d at 980. See also Pitney Bowes, 182 F.3d at 1308. It may be used to assist the court’s understanding of the patent, or the field of technology. See Markman I, 52 F.3d at 980-81. However, “courts [should] not rely on extrinsic evidence in claim construction to contradict the meaning of claims discernible from thoughtful examination of the claims, the written description, and the prosecution history- — the intrinsic evidence.” Pitney Bowes, 182 F.3d at 1308 (emphasis in original) (citing Vitronics, 90 F.3d at 1583). Judges are not usually “conversant in the particular technical art involved,” or capable of reading the patent specification and claims as one skilled in the art might. See Markman I, 52 F.3d at 986; see also Pitney Bowes, 182 F.3d at 1308-09. Therefore, “consultation of extrinsic evidence is particularly appropriate to ensure that [the court’s] understanding of the technical aspects of the patent is not entirely at variance with the understanding of one skilled in the art.” Pitney Bowes, 182 F.3d at 1309. When the court relies on extrinsic evidence to assist with claim construction, and the claim is susceptible to both a broader and a narrower meaning, the narrower meaning should be chosen if it is supported by the intrinsic evidence. See Digital Biometrics v. Identix, 149 F.3d 1335, 1344 (Fed.Cir.1998). It is entirely proper for the court to accept and admit extrinsic evidence, such as an expert’s testimony, to educate itself, but then base its construction solely on the intrinsic evidence. See Mantech Envt’l Corp. v. Hudson Envt’l Servs., Inc., 152 F.3d 1368, 1373 (Fed.Cir.1998).
Further, the Federal Circuit has taken special note of the use by courts of a specific type of extrinsic evidence: dictionaries. In its Vitronics opinion, the court explained that although technical treatises and dictionaries are extrinsic evidence, judges are free to consult these resources at any time in order to get a better understanding of the underlying technologies. 90 F.3d at 1584 n. 6. The Vitronics court stated that judges may rely on dictionaries when construing claim terms as long as the dictionary definition does not contradict the definition found in, or ascertained by, a reading of the patent. Id.
II. DISCUSSION
The allegedly infringing method in this suit is one that measures glucose using blood samples, test strips, and chronoam-perometry. Therefore, in its discussion of the claims and the context of the patent, the Court will often refer to glucose as the substance at issue.
In construing the terms of the '268 patent, the Court will apply the canons it finds relevant and reasonable in each particular instance because claim construction is a question of law, and because no canon of claim construction is “absolute in its application.” Renishaw, 158 F.3d at 1248. Of utmost importance to the process of construing claims is a consideration of the language of the claims in the necessary context. To learn that context, the Court will consult the patent specification, the prosecution history, expert reports from those skilled in the art provided by the parties, and other extrinsic evidence, if relevant. See Eastman Kodak Co. v. Goodyear Tire & Rubber Co., 114 F.3d 1547, 1552 (Fed.Cir.1997). “Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to develop with the claim.” Renishaw, 158 F.3d at 1250 (citing Markman II, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996)).
Therefore, the Court will first review the purpose for the invention as described by the '268 patent’s specification, which entails an understanding of the problem identified in the prior art that the inventor sought to solve. See Eastman Kodak, 114 F.3d at 1554. “These teachings provide valuable context for the meaning of the claim language.” Id. Then the Court will examine each of the disputed terms from the '268 patent claims and construe them according to the context and the applicable rules of construction. The result will be a definition for each disputed term and ultimately a determination of the scope of the claim in which it is used.
A. THE '268 PATENT
The Patent & Trademark Office (“PTO”) issued the '268 patent on August 17, 1999, to Neil J. Szuminsky (“Szuminsky”), Joseph Jordan, Paul A. Pottgen, and Jonathan L. Talbott (“Talbott”) (collectively, the “inventors”), and was assigned to Boehringer Mannheim Corporation (“BMC”), predecessor in interest to the plaintiff, Roche. The '268 patent matured from a continuation of application serial number 08/1776,863,. filed December 30, 1993, that was abandoned, and was a reissue of application serial number 07/745,-544, filed August 15, 1991, which matured into U.S. Patent No. 5,108, 564 (“'564 patent”). The '564 patent matured from a division of application serial number 07/322,598, filed March 13,1989, which was a continuation-in-part of an earlier filed application serial number 07/168,295, filed March 15,1988, now abandoned.
The '268 patented invention includes the method for using a disposable electroana-lytical cell to quantitatively determine the amount of biologically significant compounds, such as glucose, from body fluids. '268 Patent, Abstract; id. col. 1, ll. 18-25. The invention was designed to permit both physician and patient self-testing of such compounds with greater reliability than either the colorimetric or enzymatic ampero-metry methods that existed at the time of the invention. Id. col. 2, ll. 40-65.
Colorimetry, a technique used by physicians and patients to determine blood glucose levels, “is based upon visual or instrumental determination of color change produced by enzymatic reactions on a dry reagent pad on a small plastic strip.” Id. col. 1, ll. 47-49. This method uses oxygen, glucose’s natural oxidant, to oxidize the glucose in a sample to gluconic acid and hydrogen peroxide. Id. col. 1, ll. 49-55. Then, the hydrogen peroxide is measured either directly or indirectly by color change or by spectroscope, to determine the corresponding amount of glucose in the sample. Id. col. 2, ll. 6-12. Problems associated with the colorimetric method include (a) poor precision and accuracy because the steps are dependent upon good and consistent operating technique, id. col. 2, ll. 22-27; and (b) wide variation in calibration method, id. col. 2, ll. 27-30.
“Enzymatic amperometry methods have been applied to the laboratory based measurement of ... analytes including glucose .... ” Id. col. 2, ll. 49-51. But, this method requires individualistic calibration for each electrode in the device and “meticulous attention to electrode maintenance for continued reliable use,” both of which are training intensive and are costly. Id. col. 2, ll. 54-58. These characteristics make the method unusable for patients doing self-testing. Id. col. 2, ll. 58-62.
The '268 patent professes to address the issues of reliability, ease of maintenance and cost effectiveness so that self-testing by patients is more effective. Specifically, “[e]nzymatic amperometry provides several advantages for controlling or eliminated operator dependant techniques as well as providing a greater linear dynamic range.” Id. col. 2, ll. 43 — 46. In addition, the '268 patented invention solves the difficulties of prior art enzyme amperometry methods because it is “based on a disposable sensor that can be produced in a manner that allows it to give reproducible output from sensor to sensor and at a cost well below that of traditional electrodes.” Id. col. 2, ll. 62-65. Specifically, the '268 patented invention calls for “miniaturized disposable electroanalytic sample cells for precise micro-aliquote sampling, a self-contained, automatic means for measuring the electrochemical reduction of the sample, and a method for using the cell and apparatus ....” Id. col. 2, l. 67 to col. 3, ll. 1-4. In other words, the disposable cell acts both as a precise sample measuring device and as the site for an electrochemical reaction from which the blood glucose level can be ascertained by a reading device. See id. col. 4, ll. 15-18.
The '268 patent teaches a two-step reaction sequence. Id. col. 3, l. 16. The first step is a chemical oxidation, which utilizes an oxidant other than oxygen, preferably in an amount large enough to ensure that the oxidant is not the limiting reagent. Id. col. 3, ll. 17-25. Apparently, the test cell is configured such that the sample size is controlled without premeasurement, which adds to the invention’s advantages over prior systems for patient self-testing. Id. col. 4, ll. 3-9. In the case of glucose, the '268 patent also discloses catalytic oxidation with preferred oxidants “to convert substantially all of the B D glucose to gluconic acid.” Id. col. 4, ll. 37-41. The patent also contemplates an incubation period, “the length of which is chemistry dependent[,] to allow the enzymatic reaction to reach completion.” Id. col. 4, ll. 56-58.
In the second step, electro-chemical reduction -is used to quantify the reaction production of the first step. Id. col. 3, ll. 18-19. The '268 patent states that the second step, for the determination of glucose concentration, “utilizes Cottrell current micro-chronoamperometry in which glucose plus an oxidized electron acceptor produces gluconic acid and a reduced receptor.” Id. col. 3, ll. 43-47. “Cottrell current micro-chronoamperometry” involves “the measurement of a diffusion controlled current at an accurately specified time ... after the instant of application of a [controlled] potential....” Id. col. 3, ll. 51-54. Measurement of the current due to reoxidation of the acceptors is proportional to the glucose concentration in the sample. Id. col. 3, ll. 64-67. Because measurement of the glucose by this method is direct, it is an advantage over prior art. Id. col. 4, ll. 1-3. Moreover, the patent teaches that the method of the invention “permits automatic functioning and timing of the reaction allowing for patient self-testing with a very high degree of precision and accuracy,” another advantage over the prior art. Id. col. 4, ll. 7-9. This method practiced by the preferred embodiment measures glucose in the range of 1 mg of glucose to 1000 mg of glucose per deciliter of sample, a range of “results which have not previously been obtained using other glucose self-testing systems.” Id. col. 4, ll. 42-46.
In summary, the '268 patent discloses a method for using a disposable chemical reaction cell and an amperometry system to determine the level of biologically significant compounds, such as glucose, from body fluids, such as blood. The system is an advantage over prior colorimetric-based systems because it boasts a controlled sample size, it allows for the reaction to incubate such that the initial reaction is complete or nearly complete, and it measures the biologically significant compound directly. These advantages translate into more precise and accurate results for patients using self-testing. Because meeting these objectives is a requirement for patentability, see 35 U.S.C. § 101, the '268 patent’s claim language will be construed in the context of the problems the invention was designed to solve and in a way that renders the claims “capable of being used to effect the object proposed.” Stiftung v. Renishaw, 945 F.2d 1173, 1180 (Fed.Cir.1991) (citing Mitchell v. Tilghman, 86 U.S. (19 Wall.) 287, 396, 22 L.Ed. 125 (1873)).
The parties dispute the meaning of four terms in the '268 patent: buffer, substantially to completion (or substantially completed), Cottrell current, and electrode. Roche asserts that Inverness and Bayer infringe twenty-nine claims, however, only four of those claims, claims 1, 12, 43, and 47, are independent claims. The terms at issue are contained in these independent claims. Those claims state, in their entirety:
1. A method of measuring the amount of a selected compound in body fluids comprising:
a) providing a measuring cell having at least a first and second electrode and said cell containing an oxidant and a buffer,
b) placing a sample of fluid to be tested into said cell,
c) reconstituting said oxidant and buffer with said sample fluid to generate a predetermined reaction,
d) allowing said reaction to proceed substantially to completion,
e) applying a potential across said electrodes and sample, and
f) measuring the resulting Cottrell current to determine the concentration of said selected compound present in said sample.
12. A method of measuring the amount of an analyte in a blood sample, comprising:
a) adding the blood sample to an electrochemical cell that includes an electron transfer agent that will react in a reaction involving the analyte, thereby forming a detectable species;
b) incubating the reaction involving analyte and electron transfer agent in an open circuit until the reaction has substantially completed;
c) applying a sufficient potential difference between the electrodes of the electrochemical cell, after the incubation step, to readily transfer at least one electron between the detectable species and one of the electrodes, thereby resulting in a Cottrell current;
d) measuring the Cottrell current; and
e) correlating the measured Cottrell current to the amount of analyte in the blood sample.
* * * * i'fi *
43. A method for measuring the amount of a selected compound in a blood sample, comprising:
providing a measuring cell having at least first and second electrodes for contact with the blood sample introduced into the cell,
applying a potential to the electrodes to detect the presence of the blood sample in the cell,
placing the blood sample into the cell, removing the potential to the electrodes after the blood sample is detected in the cell,
selectively oxidizing the compound in the blood sample with an oxidized electron acceptor to produce an oxidized form of the selected compound and a reduced electron acceptor, and
re-applying a potential across the cell electrodes after the selective oxidation of the compound in the blood sample has substantially completed and measuring the resulting Cottrell current, said current being proportional to the concentration of the reduced electron acceptor and the selected compound in the blood sample.
‡ H ‡ %
47. A method for measuring the amount of glucose in blood, comprising:
providing a measuring cell with at least first and second electrodes for contact with blood introduced into the cell,
applying a potential across the electrodes,
placing a volume of blood into the cell,
removing the potential across the electrodes after the volume of blood is placed into the measuring cell,
oxidizing the glucose in the blood with an oxidized electron acceptor in the presence of glucose oxidase to produce gluconic acid and a reduced electron acceptor,
re-applying a potential across the measuring cell electrodes after the oxidation of glucose has substantially completed, and
measuring the Cottrell current through the cell, the Cottrell current being proportional to the glucose concentration in the blood.
Id. col. 13, ll. 58-67 to col. 14, ll. 1-5; id. col. 14, ll. 53-67 to col. 15, ll. 1-2; id. col. 17, ll. 47-54 to col. 18, ll. 1-15; id. col. 18, ll. 30-49 (emphasis added in all claims). The Court will construe each of the disputed terms in turn.
B. “BUFFER”
Defendant Bayer disputes the definition of the term “buffer” that is used in claim 1 of the '268 patent. Bayer argues that “buffer,” in the context of claim 1 means a solute that maintains the pH of the reaction solution during oxidation. Bayer Br. on Claim Constr. of U.S. Reissue Patent No. 36,268, at 28 (“Bayer Br.”). Bayer argues that the plain meaning of buffer is “a dissolved material in a solution that maintains the pH of the solution when acid or base is added.” Id. (citing Weber Dep. at 203; Lowe Report ¶¶ 8-10). Moreover, in the context of the '268 patent, “[t]here is only one solution involved in the method of the '268 patent — that created when the oxidant and buffer dissolve in the sample fluid (ie., are reconstituted).” Id. at 29. Finally, Bayer argues that the prosecution history confirms that the reconstituted solution is the relevant solution because the inventors “explained that the buffer functioned to maintain pH during the reactions in the cell.” Id.
In contrast, Roche urges that “buffer” means “a substance or solution capable of resisting a change in pH.” Roche Opening Br. on Claim Constr., at 24-25 (citing Van Nostrand Reinhold, Encyclopedia of ChemistRy 149 (4th ed.1984)) (“Roche Br”). The dictionary definition reads in its entirety:
When acid is added to an aqueous solution, the pH (hydrogen ion concentration) falls. When alkali is added, it rises. If the original solution contains only typical salts without acidic or basic properties, this rise or fall may be very large. There are, however, many other solutions which can receive such additions without a significant change in pH. The solutes responsible for this resistance to change in pH, or the solutions themselves, are known as buffers.
Encyclopedia of Chemistry, at 149. Roche avers that this dictionary definition is part of the prosecution history, therefore, it should provide the basis for the definition of buffer in the context of the '268 patent. Moreover, during the Markman hearing, Roche argued that the claim language and the patent specification do not require that the buffer perform its function during the oxidation reaction; it could buffer any solution referenced in the claims or the specification, including the solution used to apply the reagents to a substrate.
In the context of the '268 patent, the Court finds that “buffer” means a solute that resists a change in pH of the reaction solution. Apparently the term “buffer,” as suggested by Roche, was well known to those skilled in the art at the time of the invention to mean a solute capable of resisting a change in pH. See Encyclopedia of Chemistry, at 149 (stating that “[t]he solutes responsible for this resistance to change in pH, or the solutions themselves, are known as buffers”). During prosecution of the '268 patent, the inventors described the function of a buffer similarly:
A concise explanation of the general purpose and mechanism of buffers is disclosed by the Encyclopedia of Chemistry (Van Nostrand Reinhold Co., 1984). Buffers keep the pH of the system in a desired range. This is especially helpful for systems which include enzymes. For example, Claim 16 of the reissue application recites a method which employs enzymes.
Respective enzymes have optimum pH ranges for operation as taught by Biochemical Information, (J. Keesey, ed., Boehringer Mannheim Biochemicals, 1987). Buffer solution is used to maintain the optimum pH during detection of the sample. This achieves a precise and reliable assay.
Defs.’ Joint App. at D124. These explanations also confirm that the buffer must perform its function in a solution. But, the only solution referenced in Claim 1 of the '268 patent is the solution in which the buffer and oxidant are reconstituted — the sample where oxidation takes place.
The Court starts with the language of claim 1, in which the word “buffer” appears. Claim 1 requires that the buffer be contained in the measuring cell along with an oxidant. '268 Patent, col. 13, ll. 60-62. The claim also requires that both the buffer and the oxidant reconstitute in the sample fluid “to generate a predetermined reaction.” Id. col. 13, ll. 64-65. Because the claim requires that the buffer be reconstituted with the oxidant in the sample fluid to generate the oxidation reaction in the cell, it seems clear that the buffer is meant to function during the oxidation reaction.
This interpretation is supported by the '268 patent specification. In the description of the preferred embodiment, the patent states that in experiments run to prove the technology described in the patent, “[t]he electrolyte consisted of a phosphate buffer of pH 6.8 which was about 0.1 molar total phosphate and 0.5M potassium chloride reagent.” Id. col. 7, ll. 63-66. In addition, the patent teaches that the reagent layer of the preferred embodiment “imbibes” the sample fluid and has those concentrations of buffer and reagent. Id. col. 7, ll. 29-30 & 47-53. The patent also teaches that the relevant measurement made by the method is the current in the electrolytic solution containing the sample and the reagent. See id. col. 3, ll. 43-47; id. col. 3, ll. 64-67; id. col. 4, ll. 28-31; id. col. 6, ll. 31-37; col. 7, ll. 63-67 to col. 8, ll. 1-12; id. col. 11, ll. 11-13. Taken together, these passages identify the buffer as part of the electrolytic solution that contains the sample and the reagent before a potential is applied to measure the current.
Similarly, the disclosure in the specification related to another preferred embodiment for the measurement of cholesterol evidences that the inventors intended for the buffer to perform its function in the solution used to oxidize the cholesterol in the blood sample. For example, the patent states:
Additional examples where CO catalyzes cholesterol oxidation by ferricyanide include a Noeardia source in TRIS buffer with a variety of surfactants.... Furthermore, CO from Noeardia will also catalyze substrate oxidation with ferri-cyanide in phosphate buffer.... The buffer concentration is from 0.1 to 0.4 molar.
Id. col. 10, ll. 47-56. See also id. col. 10, ll. 26-29 (describing catalyzation of the oxidation reaction of cholesterol with CO in phosphate buffer); id. col. 10, ll. 36 — 46 (describing oxidation of cholesterol with cholesterol oxidase in 0.2 molar TRIS buffer, with ferricyanide in TRIS buffer, and with either ferricyanide or benzoquinone in phosphate buffer). Moreover, the patent teaches that for certain catalyst enzymes used in the oxidation of cholesterol, “[bluffers acceptable for this reaction to occur with the enzyme include phosphate, TRIS, MOPS, MES, HEPES, Tricine, Bicine, ACES, CAPS, and TAPS.” Id. col. 11, ll. 1-14.
The prosecution history of the '268 patent confirms that the “buffered” solution in claim 1 is the reaction solution. Claim 1 of the '268 patent is one that appeared in parent application disclosures. See Defs.’ Joint App. at A18 (File History of U.S. Patent Application No. 07/168,295, Claim 1); id. at B41 (File History of U.S. Patent No. 5,128,015 (“'015 Patent”), Claim 1, that matured from Application No. 07/322,598, a continuation in part of Application No. 07/168,295). In their reissue application for the '268 patent the inventors stated: “All claims of the original patent require the presence of a buffer and oxidant when the claimed methods are practiced.” Id. at D40. Moreover, the inventors stated that “[although Applicants do not view [a] buffer as being absolutely required in the invention, the inclusion of [a] buffer is preferred. To include a buffer when practicing the Applicants’ invention, the buffer can either be included in the electrochemical cell when a sample to be analyzed is added to the cell, or the buffer can be in the sample being analyzed.” Id. at D41. Therefore, the inventors make clear that if a buffer is necessary, it must be in the electrochemical cell during the oxidation reaction. The plain language of claim 1 requires a buffer in the cell; therefore, the buffer “buffers” the solution in which the oxidation reaction occurs.
For these reasons, the Court finds that “buffer” in the context of the '268 patent means a solute that resists a change in pH of the reaction solution.
C. “SUBSTANTIALLY TO COMPLETION” OR “Substantially completed”
1. Judicial Estoppel
As a preliminary matter, the Court finds that judicial estoppel is inappropriate in this case. Inverness argues that judicial estoppel should apply to Roche’s proposed claim construction for the term “substantially completed” or “substantially to completion.” Inverness Opening Br. on Claim Constr. at 41-46 (“Inverness Br.”). Inverness avers that Roche won the issue of the proper construction for this term in a prior proceeding before an arbitrator because the opposing party, Tall Oak Ventures, lost on the claim to which claim construction was an issue (a claim for fraud), and because Tall Oak Ventures stopped pressing its construction in a brief written after the arbitration hearing.
In contrast, Roche argues that judicial estoppel is not appropriate in this case because it did not win the arbitration and because the arbitrator’s ruling does not specify the grounds on which it was based. Roche Reply Br. on Claim Constr. at 40-43 (“Roche Reply”). Therefore, any argument that the arbitrator accepted Roche’s position on claim construction and not the Tall Oak Ventures’ position is speculation.
Apparently, Seventh Circuit law applies to this procedural issue. Lampi Corp. v. American Power Prods., Inc., 228 F.3d 1365, 1377 (Fed.Cir.2000) (citing U.S. Philips Corp. v. Sears Roebuck & Co., 55 F.3d 592, 596 n. 3 (Fed.Cir.1995)). Judicial estoppel is an equitable doctrine “that prevents a party who prevails on one ground in a lawsuit from then repudiating that ground in order to prevail in another lawsuit.” Id. (citing McNamara v. City of Chicago, 138 F.3d 1219, 1225 (7th Cir.1998)). Moreover, “[t]he doctrine also applies to administrative proceedings in which a party obtains a favorable order by making an argument that it seeks to repudiate in a subsequent judicial proceeding.” Id. (citing Chaveriat v. Williams Pipe Line Co., 11 F.3d 1420, 1427 (7th Cir.1993)). Some courts have held that judicial estoppel applies to positions taken before an arbitrator. See, e.g., Lydon v. Boston Sand & Gravel Co., 175 F.3d 6 (1st Cir.1999); Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc., 149 F.Supp.2d 610, 613-14 (S.D.Ind.2001). The Court is persuaded that judicial estoppel may apply to positions taken before an arbitrator. See Kale v. Obuchowski, 985 F.2d 360, 362 (7th Cir.1993) (stating that the Seventh Circuit could not find a case that “makes application of judicial estoppel depend on the existence of a judicial opinion adqpting the litigant’s position; it is enough that the litigant win”).
Here, the Court cannot conclude that Roche obtained a favorable ruling on the appropriate construction of the term “substantially to completion” or “substantially completed” in the '268 patent during a prior arbitration proceeding. Claim construction of the '564 and '015 patents, parent patents to the '268 patent, was a sub-issue in Tall Oak Ventures’ claim that Roche fraudulently represented that its glucose meter did not infringe the '564 and '015 patented technology. Inverness avers that Roche argued in its pre-hearing brief that the term “substantially to completion” or “substantially completed” in the '564 and '015 patents means “99.9% of the glucose in the entire sample is converted into gluconic acid before the potential is applied.” Inv.App., Exh. 10, Pre-Hearing Br. of Respondent, BMC, Tall Oak Ventures v. Boehringer Mannheim Corp. Ref. No. 55-199-0078-95, at 33 (“Roche Pre-Hearing Arb. Br.”). But see Inv.App., Exh. 11, Post Hearing Br. of Respondent, BMC, Tall Oak Ventures v. Boehringer Mannheim Corp., Ref. No. 55-199-0078-95, at 5 (stating that “the evidence of record, all from Tall Oak documents or witnesses, conclusively establishes that the claims of the '564 patent require that substantially all of the glucose in the sample or drop is converted to gluconic acid before the potential is applied”) (“Roche Post Hearing Arb. Br”). Roche came to this conclusion based on the specification and the file history of the '564 and '015 patents. Inv.App., Exh. 10, Roche Pre-Hear-ing Br., at 33. Inverness argues that the arbitrator’s award of $1,100,000 to Tall Oak Ventures evidences that Roche won the issues relevant to Tall Oak Ventures’ fraud claim because Tall Oak Ventures had sought damages of $71,000,000 on that claim. Inv. Br. at 43. In addition, if Tall Oak Ventures had prevailed on the fraud claim, it would have been entitled to rescission of the patent purchase agreement it had with Roche. Id. at 45.
Instead, Inverness speculates that the arbitrator’s award to Tall Oak Ventures was premised on Roche’s breach of its obligation of good faith and fair dealing. Id. Inverness argues that testimony by a Roche representative during the arbitration hearing would support such a finding. Id. (citing Inv.App., Exh. 14, Transcript of Proceedings, Vol. IV, Tall Oak Ventures v. Boehringer Mannheim, Ref. No. 55-199-0078-95, at 2659-2660 (“Arbitration Hrg. Tr.”)). Further, Inverness opines that “[t]he arbitrator clearly signaled during the hearing that he was moving in this direction.” Id. Specifically, Inverness points to the following comments and questions in the arbitration hearing transcript:
THE ARBITRATOR: Suppose that we were to find that there was a trade secret involved and that [Roche] did take the trade secret of Tall Oak’s personnel in coming up with the palladium same size, same material, and that’s all, and not go into the question of the patents, just—
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THE ARBITRATOR: But suppose that was [Tall Oak Ventures’] trade secret and [Roche] took it and [Roche is] going to pay [Tall Oak Ventures] for it, and as a result of [Roche’s] payment for the trade secret, [Roche] now become[s] the owner and [Roche] becomefs] the owner of the patent and so therefore [Roche] could work in that fashion, couldn’t you?
* * * * *
THE ARBITRATOR: As a result of the damages, whatever they may be, for the misappropriation of trade secrets, I assume what you’re saying is that the trade secret, whatever that property right is, then turns over and becomes the property of [Roche] after [Tall Oak Ventures is] paid and [Roche] has a right to retain the patent.
MR. KLINE [Counsel for Roche]: Yes.
Inv.App., Exh. 14, Arbitration Hrg. Tr., Vol. VI, at 1698 1700. Inverness argues that this commentary indicates that the arbitrator was clearly thinking about an award premised only on Roche’s conduct in the 1988-1989 time frame, not for Roche’s alleged misrepresentation on infringement in 1992. Inv. Br. at 45-46.
The Court is not convinced that this combination of award amount and arbitration hearing conversation indicate that Roche won the argument on claim construction. There is nothing in the arbitrator’s original decision to indicate the basis for the $1,100,000 award to Tall Oak Ventures. It merely orders BMC to pay Tall Oak Ventures that amount and sets forth other rules for the award including that it “is in full settlement of all claims, counterclaims, and all matters submitted to the arbitrator by motion or otherwise.” Inv. App, Exh. 15, Award of Arbitrator, Tall Oak Ventures v. David Giddings, Chief Executive Officer, Boehringer Mannheim Corp., Ref. No. 55-199-000078-95, ¶¶ 1, 6 (Sept. 25, 1996). Therefore, the arbitrator’s award could have been predicated on a finding of liability for any of Tall Oak Ventures’ claims against Roche. The arbitrator’s clarification of the award provides little further clarity. The clarification states in relevant part:
By way of clarification, my award of $1.1 million dollars was to compensate Tall Oak for past liability. The award was not intended to discharge BMC from making the contingency and interest payments due under Section 1.2 of the Patent Estate Purchase Agreement (“PEPA”) upon issuance of European Patent Office (“EPO”) and Japanese patents.
Moreover, since the basis for Tall Oak’s alleged ground for Breach of the PEPA, as mentioned in its October 3, 1996 letter, was not raised at the hearing, there is no basis for Tall Oak’s claim of a default rate of 18% interest, as provided by Section 7.2 of PEPA, on the $350,000.00 and $150,000.00 payments that will be due from BMC upon issuance of European and Japanese patents respectively or, in the alternative, for return of the EPO and Japanese patent applications to Tall Oak.
Inv.App., Exh. 15, Clarification of Award of Arbitrator, Tall Oak Ventures v. David Giddings, Chief Executive Officer, Boehringer Mannheim Corp., Ref. No. 55-199-0078-95 (Oct. 9, 1996). The context of this clarification suggests that the $1,100,000 award was based on some type of breach of contract damages because the arbitrator references additional obligations for Roche under the contract at issue. In addition, as Inverness points out, if the arbitrator had found for Tall Oak Ventures on the fraud claim, presumably he would have rescinded the PEPA. However, the clarification still makes no definitive ruling on the fraud claim.
Even if the Court were to accept Inverness’ argument that the arbitrator found for Roche on Tall Oak Ventures’ fraud claim, there is no evidence that the arbitrator accepted Roche’s position on claim construction in making such a ruling. Roche specifically argued that Tall Oak Ventures could not prove three elements of fraud against it. Those elements were: “(1) a misrepresentation made with (2) intent to deceive, and (3) justifiable reliance.” Inv.App., Exh. 10, Roche Pre Hearing Br., at 31. Claim construction, as the first step of an infringement analysis, is relevant to only one of these elements, “misrepresentation.” Id. Moreover, Roche argued that Tall Oak Ventures could not prove by “clear, precise and convincing” evidence that it justifiably relied upon Roche’s assertion that its product did not infringe the patents. Roche based it argument on the fact that one of the principals of Tall Oak Ventures admitted that the $1, 250,000 Roche paid for the patents gave him “ ‘some comfort should [Tall Oak Ventures] come to a different conclusion [on infringement] regarding the technology embodied in the BMC glucose bio-sensor, once it becomes available.’ ” Id. at 37 (quoting Letter, From Dr. Pottgen, To Max Kenemore, Patent Counsel, May 11, 1992). Arguably, then, the arbitrator could have made a ruling for Roche and against Tall Oak Ventures on the fraud claim for reasons completely unrelated to claim construction of the patents at issue. With this finding, the Court is persuaded that judicial estoppel cannot apply in this case.
The cases that Inverness cites for the proposition that judicial estoppel may apply if a party prevails only on a subsidiary issue are not apposite. See Bethesda Lutheran Homes & Servs., Inc. v. Born, 238 F.3d 853, 857-58 (7th Cir.2001); In re Cassidy, 892 F.2d 637, 641-42 (7th Cir.1990). In those cases, it was clear that the first court had ruled in favor of the party who changed its position in the second case. See Bethesda Lutheran Homes & Servs., 238 F.3d at 857-58 (“The plaintiffs argued in the first suit that the relevant Medicaid regulations and Wisconsin state law were unconstitutional. Having won that suit to the extent of getting the legal obstacles to Medicaid reimbursement removed, they could not turn around and in the next suit seek additional relief by arguing that the regulations and state law were constitutional after all and compelled the defendants to grant them benefits.”); In re Cassidy, 892 F.2d at 641 (“[Party] unequivocally urged the [first] court to consider the defense of discharge. His present position is that it was error for the court to give him what he then wanted.”). As described above, it is not clear whether the arbitrator ruled in favor of Roche on the fraud claim. Even if the Court accepted Inverness’ argument that the arbitrator did rule in favor of Roche on Tall Oak Ventures’ fraud claim, it is not clear that the arbitrator ruled in favor of Roche on that claim because he accepted Roche’s claim construction over that of Tall Oak Ventures’.
Inverness also argues that Tall Oak Ventures capitulated the issue of claim construction on the “substantially completed” patent term; therefore, judicial estop-pel is appropriate for that reason. Inv. Br. at 43-44 (citing Kale v. Obuchowski, 985 F.2d 360, 362 (7th Cir.1993); Inv.App., Exh. 13, Tall Oak Ventures’ Post Hearing Br., at 6). In Kale, the Seventh Circuit stated that “[p]ersons who triumph by inducing their opponents to surrender have ‘prevailed’ as surely as persons who induce the judge to grant summary judgment.” Kale, 985 F.2d at 362 (citing Maher v. Gagne, 448 U.S. 122, 100 S.Ct. 2570, 65 L.Ed.2d 653 (1980)). Inverness points to a portion of Tall Oak Ventures’ post-hearing brief that talks about whether Roche’s product might infringe the Tall Oak Ventures patents for its argument that Tall Oak Ventures capitulated the issue of claim construction for the term “substantially to completion.” The relevant paragraphs state in part:
On January 2, 1992, Walling of BMC wrote an internal memorandum in which he stated “the Magellan product may infringe patent claims that will issue to [Tall Oak Ventures].” PX 607. Walling stated therein that “utilizing the Magellan product to conduct an assay of an analyte may infringe some of [Tall Oak Ventures’] method claims.” Walling further concluded “if the Magellan product measure Cottrell current before the reaction goes substantially to completion, then we have an argument that utilizing the Magellan product to measure an analyte does not infringe [Tall Oak Ventures’] method claims.” Dr. Kissinger, BMC’s own expert elec-troehemist, testified at the hearing that [tests on the Magellan product] were flawed. TR 3441. Critically, Kissinger was never consulted on this issue prior to the time BMC purchased [Tall Oak Ventures’] patents even though he was consulted by BMC on other issues. TR 3247.... Most importantly, as Dr. Kissinger testified “the reaction always goes to completion.” TR 3454. By this, he meant that “99.9 percent of them (glucose molecules) are converted to gluconic acid in this reaction. [”] TR 3454; 3459.
The reaction of glucose in the 4 microli-ter well of the Accu Chek Advantage product has proceeded substantially to completion before the 300 mV potential is applied, and BMC has never had, and does not now have, a reasonable basis for believing otherwise.
InvApp., Exh. 13, Tall Oak’s Post Hearing Br., at 6-7. Inverness avers that with this argument, Tall Oak Ventures failed “to rebut Roche’s arguments with respect to the correct interpretation of the ‘substantial completion’ limitation!” Inv. Br. at 44. But, it is clear that Roche’s interpretation of the '564 and '015 “substantial completion” limitation was more narrow than that proposed by Tall Oak Ventures. The passage above, in reference to the Roche glucose meter, describes how the Roche product infringes the “substantial completion” limitation even under Roche’s more narrow construction. It follows that if the “substantial completion” limitation in its more narrow interpretation reads on Roche’s device, the Tall Oak Ventures’ more broad interpretation of that limitation will also read on the device. In other words, the Court does not read Tall Oak Ventures’ argument as a capitulation on the construction for the term “substantially to completion.” Rather, the argument cleverly uses Roche’s expert’s testimony about what the Roche product does to prove that Roche’s device infringed the '564 and '015 patents, regardless of how the arbitrator resolved the claim construction issue.
In addition, Tall Oak Ventures’ post-hearing brief only argues about the accuracy of Roche’s assertion that its product did not infringe Tall Oak Ventures’ patents. There is no argument that its reliance on such assertions was justified. Applying Inverness’ argument to this finding, Tall Oak Ventures capitulated on this issue and lost the fraud claim because the arbitrator found against it on this element. But, there is no more evidence that the arbitrator found against Tall Oak Ventures on the fraud claim because he agreed with Roche’s position on this element than there is evidence that the arbitrator found against Tall Oak Ventures on the fraud claim because he agreed with Roche’s position on construction for the term “substantially to completion.” As discussed above, the arbitrator neither clearly found in favor of Roche on the fraud claim nor clearly accepted Roche’s claim construction if he found for Roche on the fraud claim.
The Court finds that any decision to limit Roche’s arguments in this Court based on a position it took on the fraud claim during the arbitration would force the Court to speculate on the basis for the arbitrator’s decision in the first action. Because the case lav/ on judicial estoppel supports application of the doctrine only in those cases where the first court accepted the argument of the party sought to be estopped, the Court declines Inverness’ invitation to apply judicial estoppel to Roche’s arguments about the proper construction for the “substantially completed” limitation in the '268 patent.
2. Claim Construction
The “substantially to completion” or “substantially completed” phrase used in the '268 patent is found in all of the independent claims; the step in which it appears requires a reaction between the sample and the reagent to proceed “substantially to completion” or to be “substantially completed” before the next step. See '268 Patent, col. 13, ll. 66-67; col. 14, l. 61; col. 18, l. 11; col. 18, ll. 45-46. The parties dispute two facets of this phrase: what “substantially completed” actually means and where the reaction must reach “substantial completion.”
Roche argues that the common meaning for the term “substantially” as defined in binding precedent, see York Products, Inc. v. Central Tractor Farm & Family Center, 99 F.3d 1568, 1572 (Fed.Cir.1996), is the correct meaning in the context of the '268 patent. Specifically, “substantially” means either “largely but not wholly,” or “considerable in extent.” Id. (quoting from WebsteR’s Collegiate DICTIONARY and American Heritage Dictionary 2nd College Edition, respectively). Moreover, Roche argues that the predetermined reaction that happens when the sample is placed on the cell “does not have to proceed to completion in the entire sample, but rather only in that portion of the sample in which the re[a]gents have dissolved before the potential is applied.” Roche Reply Br. on Claim Constr., at 6 (“Roche Reply”). In other words, the reaction need only go to substantial completion in the “reagent layer.” Id. at 10 (citing '268 Patent, col. 7, ll. 29-30). See also '268 Patent, col. 12, ll. 28-32.
In contrast, Bayer asserts that “[t]he glucose/oxidant reaction has gone ‘substantially to completion’ when at least 99.9% of the glucose in the sample placed in the cell is oxidized [before the potential is applied]; the reaction is not substantially completed when substantially all of the analyte in only a thin layer of the sample placed in the cell has been oxidized.” Bayer Br. at 22. Bayer contends that this construction is consistent with the specification and the prosecution history of the '268 patent. Id. at 23-28. In particular, the fact that this step must be “substantially completed” before measurement of the Cottrell current implies that the concentration of the sample is constant before the potential is applied. See id. at 23-24. In addition, Bayer contends that the PTO specifically allowed these claims in the '268 patent over prior art because the inventors argued that in their invention the entire sample in the well had to react in order for the Cottrell equation to accurately predict that amount of biological compound in the sample. See id. at 12-13 (citing Defs.’ Joint App. at B78-79, B276-78, B280, B284); id. at 24 (citing Defs.’ Joint App. at 73, 82, D183).
Similarly, Inverness argues that the “substantially completed” limitation means “the reaction involving the glucose in the entire sample must proceed as far as it can, at which point, the specification teaches, ’99.9+ percent’ of the glucose in the sample has been converted to gluconic acid.” Inverness Br. at 21. Inverness avers that “substantial” is an open-ended word or a “word of degree” that would render the claims meaningless without quantification. Id. at 21-22. Moreover, Inverness relies upon the portion of the specification that states, “Gluconic acid yields of 99.9+ percent were attained in the presence of glucose oxidase,” for the proposition that “substantially” must mean “99.9+ percent.” Id. at 23 (citing '268 Patent, col. 8, ll. 23-25). In addition, like Bayer, Inverness argues that the prosecution history confirms that the inventors distinguished their invention on the basis that the “entire well volume” was reacted. Id. at 23-24. Therefore, substantial completion requires that the “entire well volume” react before a potential is applied.
In the context of the '268 patent, including the disputed claims, the undisputed claims, the specification and the prosecution history, the Court finds that “substantially to completion” or “substantially completed” means nearly to the end or nearly ended. With respect to where the reaction must be substantially completed, the Court finds that the reaction must be substantially completed in the entire sample,
a.) The Meaning of “Substantially Completed”
The Court starts with the plain meaning of the claim language. Claim 1 uses the term “substantially to completion” in the context of what happens to the reaction between the sample fluid and the oxidant. See '268 Patent, col. 13, ll. 63-67. Similarly, the other independent claims at issue, claims 12, 43, and 47, talk about a reaction or an oxidation that has “substantially completed.” Id. col. 14, ll. 59-61; id. col. 18, ll. 10-11; id. col. 18, ll. 45^6. The non-asserted independent claims also teach reactions that have “substantially completed.” Id. col. 16, l. 6; id. col. 16, l. 33; id. col. 16, l. 65; id. col. 17, l. 21. In the context of the claim language where the focus is on what happens to a chemical reaction or oxidation (a special type of chemical reaction), the term “substantially to completion” or “substantially completed” likely means that the reactants are nearly all used up and there is little transformation continuing. This understanding is more succinctly phrased by consulting a dictionary, keeping in mind the context of a reaction between two or more chemicals.
The term “substantially” in normal usage implies considerable in amount or extent. See WebsteR’s Third New International Dictionary 2280 (Unabridged 1981) (“Webster’s Unabridged”); AMErican Heritage Dictionary (3d Ed. SoftKey Int’l Inc. 1994). Or, as suggested by Roche, largely but not wholly. See Roche Br. at 28 (citing York Prods., 99 F.3d at 1572 (quoting Webster’s Collegiate Dictionary)). Completed, or completion, in normal usage implies finished, done or ended. This common language definition comports with the dictionary definition for complete: “brought to an end or to a final or intended condition.” Webster’s Unabridged, at 465. In the context of the claims, where the subject at issue is a reaction between chemicals, “substantially completed” likely means considerably or largely finished.
In contrast to the claim language where the extent of the reaction is qualified by the word “substantially,” the '268 patent’s specification rarely makes such qualification. Specifically, the patent teaches that a preferred embodiment “involves a two-step reaction sequence utilizing a chemical oxidation step using other oxidants than oxygen, and an electro-chemical reduction step suitable for quantifying the reaction production of the first step.” '268 Patent, col. 3, ll. 16-19. There are no words of limitation here on the extent of the oxidation reaction. Moreover, the patent teaches the importance of a chemical reaction system that uses an oxidant other than oxygen “in a large excess of the analyte” to “ensure that the oxidant is not the limiting reagent” because the inventors wanted “a quantitative conversion of the analyte.” Id. col. 3, ll. 19-25. Therefore, it appears that largeness in quantity of the oxidized chemical is important to the invention. Moreover, in the preferred embodiment where the analyte is glucose, the patent reads that the “chemical oxidation reaction has been found to precede to completion in the presence of an enzyme.... ” Id. co. 3, ll. 29-30. Similarly, the patent teaches: “The first reaction is an oxidation reaction which proceeds to completion in the presence of the enzyme glucose oxi-dase.” Id. col. 4, ll. 26-28. Again, there are no words qualifying the extent of the oxidation reaction in these descriptions of the preferred embodiment, implying that the reaction is fully complete. This conclusion follows from the earlier emphasis on the importance of the quantity of the oxidized reaction product.
In another description of the preferred embodiment, the patent teaches:
The main difference between these two techniques consists of applying the appropriate controlled potential after the glueose-benzoquinone reaction is complete....
It should be noted that Cottrell chro-noamperometiy of metabolites needs the dual safeguards of enzymatic catalysis and controlled potential electrolysis. Gluconic acid yields of 99.9+ percent were attained in the presence of glucose oxidase.
Id. col. 8, ll. 13-25. Again, there are no words of limitation on the extent of completeness of the oxidation reaction. In fact, the patent teaches that when the catalyst glucose oxidase is used in the method described, experiments showed that 99.9+ percent of the glucose was converted to gluconic acid. All of these descriptions, however, specifically refer to a preferred embodiment of the invention where glucose is the analyte and glucose oxidase is used as the catalyst.
In addition, the patent also states that “[i]t has now been discovered that the preferred oxidants described [in the patent for glucose, ferricyanide, ferricinium, cobalt III orthophenanthroline and cobalt (III) dipyridyl,] have sufficiently positive potentials to convert substantially all of the B D glucose to gluconic acid.” Id. col. 4, ll. 384Ü. Here, even with reference to the preferred embodiment of oxidation of glucose to gluconic acid, the patent qualifies the extent of the reaction using “substantially.” However, it seems that the patent teaches the importance of allowing the reaction between the analyte and the oxidant to proceed as close to completion as reasonably possible. As described above, the description of the preferred embodiments for glucose make this apparent. Therefore, a definition for “substantially to completion” or “substantially completed” that incorporates the concept that the reaction has nearly ended best captures the intent of the claims.
Both Bayer and Inverness argue that “substantially” is a word of degree, which in the context of the '268 patent is specifically defined as “99.9+ percent.” Bayer Br. at 23; Inverness Br. at 23