Medtronic, Inc. v. Boston Scientific Corp. (777 F. Supp. 2d 750, 2011)

OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

Plaintiff Medtronic, Inc. (“Medtronic” or “plaintiff’) filed this complaint on Decernber 17, 2007, against Boston Scientific Corporation (“BSC”), Guidant Corporation (“Guidant”), and Mirowski Family Ventures LLC (“MFV,” collectively “defendants”) for declaratory judgment of non-infringement and invalidity of United States Reissued Patent Nos. RE 38,119 (“the '119 patent”) and RE 39,897 (“the '897 patent,” collectively “the reissue patents”). (D.I. 1) Thereafter, plaintiff amended its complaint twice, first to add a defense of prosecution laches, and then to assert non-infringement of two new products. (D.I. 84; D.I. 108) BSC and Guidant filed an answer on February 2, 2008, and thereafter amended it twice. (D.I. 18; D.I. 88; D.I. 115) MFV also filed an answer on February 2, 2008 and amended it twice. (D.I. 20; D.I. 89; D.I. 114) On December 2, 2009, the parties submitted their joint claim construction chart. (D.I. 144) The court conducted a Markman hearing on January 7, 2010.

A bench trial was held January 25-28 and March 13, 2010 on validity and enforceability of the reissue patents and whether any of the accused products infringe any valid asserted claim. On March 30, 2010, the parties stipulated that in post-trial briefing, plaintiff would file opening and reply briefs, and defendants would file only an answering brief. (D.I. 187) On February 7, 2011, the court ordered that defendants may file a sur-reply brief addressing only the issue of infringement as discussed in plaintiffs reply post-trial brief. (D.I. 253) Pursuant to the court’s order, defendants filed a sur-reply brief on February 22, 2011. (D.I. 254) The issues at bar have been fully briefed post-trial. The court has jurisdiction pursuant to 35 U.S.C. §§ 1 et seq. and 28 U.S.C. §§ 1331, 1338(a), 1400(b) and 2201. Having considered the documentary evidence and testimony, the court makes the following findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a).

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. Background

1.The parties and litigation history

1. Medtronic, BSC, and Guidant are all leading manufacturers and sellers of medical devices. (D.I. 86 at 2) Medtronic is a Minnesota corporation with a principal place of business in Minneapolis, Minnesota. (D.I. 115 at 1) Medtronic is engaged in the business of manufacturing, promoting, offering for sale, and selling certain implantable cardiac stimulation devices that are capable of providing cardiac resynchronization therapy (“CRT”). (D.I. 114 at 1; D.I. 115 at 1) BSC is a Delaware corporation with a principal place of business' in Natick, Massachusetts. (D.I. 115 at 1) Guidant is an Indiana corporation with a principal place of business in Carmel, Indiana, and is a wholly-owned subsidiary of BSC. (Id) Guidant is the exclusive licensee of the reissue patents. (Id.) MFV is a Maryland limited liability company which holds the patent rights of Michel Mirowski, M.D., inventor of the implantable cardiac defibrillator (“ICD”), and is the assignee of the reissue patents. (D.I. 86 at 2; D.I. 114 at 1)

2. There is a long history of litigation involving the parties in the case at bar. (See D.I. 86 at 1-8) Ely Lilly & Co. (“Lilly”), Guidant’s predecessor-in-interest to the reissue patents, entered into a sublicense agreement (“Lilly agreement”) with Medtronic in 1991 covering, inter alia, the '119 patent. (DTX-87 at 1) The Lilly agreement gave Medtronic the right to challenge allegations of infringement of the '119 patent as well as the validity and enforceability of the '119 patent through one or more declaratory judgment actions. (Id)

3. In 2003, by agreement of the parties, Medtronic began paying royalties into escrow on sales of certain products, while at the same time challenging the validity of the '119 patent (“2003 litigation”). (Id.) In 2004, the validity and enforceability of the '119 patent was also placed at issue in litigation between Guidant and St. Jude Medical, Inc. (“St. Jude litigation”). (Id.)

4.In 2006, Medtronic, Guidant, and MFV entered into a “Litigation Tolling Agreement” (“LTA”). (DTX-87) The LTA recognized that “an actual controversy exists ... as to the scope, validity and enforceability of the '119 patent, and whether or not any valid and enforceable claims thereof cover Medtronic products, and consequently the proper distribution of substantial monies residing in or to be paid into various escrow accounts.” (Id. at 2) The LTA tolled and suspended various litigation and defenses thereto pending the conclusion of the “DJ Suspension Period” and for ninety (90) days after receipt by Medtronic of a notice of infringement from Guidant or MFV. (Id. at 5) The “DJ Suspension Period” was defined to be “the later of: (a) final resolution of the St. Jude Litigation (including settlement thereof), or (b) October 1, 2007.” (Id. at 2) The LTA provided that, within 60 days after the DJ Suspension Period, defendants could provide written notice to Medtronic of infringement of the '119 patent or subsequent reissue patents claiming priority to the '119 patent. (Id. at 5) The LTA further provided that, within 90 days after such notice, Medtronic could initiate a final declaratory judgment, in this court, challenging infringement, unenforceability and/or validity of the asserted claims of the '119 patent and any asserted claims of any subsequent reissue patent(s). (Id. at 6) The declaratory judgment complaint in the present action was filed pursuant to the LTA. (D.I. 1)

2. The heart, its maladies and treatment

5. The human heart is divided into four chambers. (D.I. 154, ex. 1 at ¶ 22; D.I. 146 at 3) The two upper chambers of the heart are called the left and right atria and receive blood from the body or lungs. (D.I. 154, ex. 1 at ¶¶22, 23; D.I. 146 at 3) “One upper chamber is called an ‘atrium,’ while both upper chambers together are called the ‘atria.’ ” (D.I. 154, ex. 1 at ¶ 22) The two lower chambers in the heart are called the left and right ventricles and are the pumping chambers of the heart. (Id.; D.I. 146 at 3) When the ventricles contract, blood is pumped out of the heart with enough force to push blood through the lungs and entire body. (Id.)

6. The left and right sides of the heart are separated by a wall, called the septum. (D.I. 154, ex. 1 at ¶23; D.I. 146 at 3) Deoxygenated blood (blood with no oxygen) returning to the heart from the body moves through the right side of the heart. (Id.) Oxygenated blood (blood with oxygen) returning from the lungs moves through the left side of the heart. (Id.)

7. The right atrium receives deoxygenated blood from the body. (D.I. 154, ex. 1 at ¶ 22; D.I. 146 at 3) When the right atrium contracts, blood is pushed into the right ventricle. (Id.) Once the right ventricle has filled, it contracts and pumps blood to both lungs. (Id.) Blood is circulated through the lungs where carbon dioxide is removed and oxygen is absorbed. (D.I. 146 at 3)

8. Oxygenated blood returns to the heart into the left atrium. (Id.) When the left atrium contracts, blood is pushed into the left ventricle. (Id.) When the left ventricle contracts, blood is pushed on to the rest of the body. (Id.) The circulatory cycle then begins again. (Id.)

9. A variety of problems can cause the heart to behave abnormally. (D.I. 148, ex. 1 at 5-6) One problem involves the heart’s electrical system, which can affect the timing of the heart, resulting in arrhythmias (rhythm disorders). (Id.) One such disorder is bradycardia, a condition in which the heart beats too slowly. (Id.) Tachycardia, on the other hand, is a condition in which the heart beats too rapidly. (Id. at 7) Fibrillation is a condition in which the heartbeat is chaotic, or irregular, and the heart may skip beats. (Id.)

10. Treatment of these electrical disorders usually involves an implantable electronic device for stimulating the heart. (Id.) Bradycardia is treated using a pacemaker, a device that sends electrical impulses to the heart through electrical leads (wires) in the right atrium and right ventricle to maintain a suitable heart rate. (Id. at 6-7) Tachycardia and fibrillation are usually treated using an implantable cardioverter defibrillator (“ICD”). (Id. at 7) Compared to pacemakers, ICDs deliver a massive high-energy pulse (shock) to the heart through electrical leads to stop the arrhythmias. (Id.)

11. Separate from the timing problem of arrhythmias, a heart may also suffer from structural problems that affect its pumping ability, such as heart failure. (Id. at 8) Heart failure is a disease in which the heart progressively loses its ability to effectively pump blood. (Id.)

12. Pacing of the heart, using a pacemaker, is performed in various modes described by a shorthand positional notation according to at least the following three parameters: (1) the chamber(s) where pacing occurs; (2) the chamber(s) where sensing occurs; and (3) the response to sensing. (D.I. 188 at 80:23-86:10) In this notation, the chambers paced and sensed are designated by characters, where “0” represents zero or none, “A” represents atrium, “V” represents ventricle, and “D” represents dual (A+V). (Id.) The response to sensing is designated by the characters “O” representing zero or none, “T” representing triggered output in response to a sensed event, “I” representing inhibited output in response to a sensed event, and “D” representing dual (T+l). (Id.)

13. The modes relevant to the reissue patents are: VOO, WI, VDI, VVT, VAT, and VDD. VOO mode, also known as “Fixed-rate Ventricular pacing,” describes ventricular pacing with no sensing. (D.I. 188 at 82:6-21; D.I. 193 at 42) WI mode indicates activity is sensed in the ventricle, and stimulation of one ventricle is inhibited if intrinsic electrical activity is sensed. (D.I. 188 at 83:2-24; D.I. 193 at 42) VDI mode indicates activity is sensed in the ventricle and/or atrial chambers, and stimulation of one ventricle is inhibited if intrinsic electrical activity is sensed. (D.I. 188 at 83:2-24; D.I. 193 at 42) WT mode, or “Triggered pacing,” indicates stimulation of one ventricle is triggered upon the sensing of an electrical signal in another ventricle. (D.I. 188 at 83:25-84:3; D.I. 193 at 42) VAT mode, or “atrial-triggered, ventricular pacing,” indicates that the ventricle is paced if electrical activity is sensed in an upper (atrial) chamber of the heart. (D.I. 188 at 84:19-85:4; D.I. 193 at 42) Finally, in VDD mode, stimulation of the ventricle can be inhibited or triggered if intrinsic activity in the atrial or ventricular chambers is sensed. (D.I. 188 at 85:23-86:9; D.I. 193 at 42)

3. Dr. Mower’s invention

14. Dr. Mower is a renowned researcher in the cardiology field, having been inducted into the National Inventors Hall of Fame for his invention, in the 1970s with Dr. Mirowski, of the first ICD. (D.I. 189 at 479:7-481:10) As a practicing cardiologist in the 1980s, Dr. Mower concerned himself with the treatment of congestive heart failure, a condition more widespread than ventricular fibrillation for which the ICD was invented. (Id. at 481:20-482:8) At the time, Dr. Mower was practicing at Sinai Hospital in Baltimore, Maryland, where he “ran the heart station, which ... did most of the EKG reading.” (Id.) Dr. Mower noticed that “those patients who were diagnosed [with] congestive heart failure generally had widened QRSs,” from which he inferred that “there was a slow conduction from one side of the heart to the other, and [ ] realized that there might be incoordinate contraction playing at least some role in the heart failure.” (Id. at 488:7-22) This insight led to the invention that is the subject of the reissue patents. (Id. at 488:12-489:2)

15. Dr. Mower’s invention is directed to a device to treat ventricular asynchrony. Medtronic v. Guidant Corp., Civ No. 03-848-SLR, 2004 WL 5501181 at *3-4 (D.Del. Oct. 6, 2004). Ventricular asynchrony is a condition in which the patient has a conduction defect in his ventricles causing the ventricles to contract at different times. Id. Dr. Mower’s invention addresses this defect by pacing the heart so as to cause substantially simultaneous ventricular contractions. Id. Unlike treating an arrhythmia (where the concern is the quantity of heartbeats), because the patient is suffering from heart failure, continuous bi-ventricular pacing improves the output of the heart and, therefore, the quality of the heartbeats, (D.I. 190 at 528:13-25) “Bi-ventricular pacing (or pacer/pacemaker),” a term used in the reissue patents, is now referred to as cardiac resynchronization therapy. ('119 patent at col. 3:56-57, col. 6:3-14, col. 7:17-20, and claims 9-13, 22-26; '897 patent, claims 132-133; D.I. 146, ex. 2 at 17)

4. The reissue patents

16. The reissue patents are both reissues of U.S. Patent No. 4,928,688 (“the '688 patent”). (Reissue patents at [64]) The '688, '119 and '897 patents are directed to a method and apparatus for treating hemodynamic dysfunction by using electrodes to simultaneously stimulate the ventricles of the heart. ('688, '119 and '897 patents, Abstract) The reissue patents share the specification and priority date of the '688 patent. (D.I. 147 at 2 n. 2) The '688 patent issued on May 29, 1990 from application No. 07/299,895 (“the '895 application”), filed on January 23, 1989. ('688 patent at [21, 22, 45])

17. The '119 patent issued on May 20, 2003 from application No. 08/547,691 (“the '691 application”), filed on October 19, 1995. ('119 patent at [21, 22, 45]) The '691 application was a continuation of application No. 10/214,474, (“the '474 application”) filed Aug. 8, 2002, which in turn was a continuation of application No. 07/890,-280, (“the '280 application”) filed May 29, 1992, which was later abandoned. ('119 patent at [63])

18. The '897 patent issued on October 23, 2007 from application No. 10/214,474, filed on August 8, 2002. ('897 patent at [21, 22, 45]) The '897 patent is a continuation of the '119 patent. ('897 patent at [63])

19. The named inventor of the reissue patents is Morton M. Mower. (Reissue patents at [75]) Since a reissued patent is valid only for the “unexpired term of the original patent,” the reissue patents each expired on January 23, 2009. See 35 U.S.C. 251.

20. Defendants allege that plaintiff infringed one or more of claims 15, 19, 20, 25 and 26 of the '119 patent and claims 15, 54, 84, 86, 120, 144, 172, 201, 217, 233, 248, 273, 288, 303, 308, 311, 315 and 324-328 of the '897 patent. (D.I. 188 at 4:22-25, 137:22-138:13; PTX-515)

5. Accused devices

21. Defendants accuse plaintiffs In-Sync, InSync ICD, InSync II Marquis, InSync Maximo, InSync II Protect, InSync Sentry, Concerto, Maximo II and Consulta devices (collectively “accused devices”) of infringing the reissue patents. (D.I. 192 at 868:8-17; PTX-567) The accused devices are all cardiac resynchronization therapy devices. (D.I. 189 at 334:11-335:4) Although similar, slight differences exist among the accused products. (Id.) The InSync device does not provide defibrillation therapy, whereas the remaining accused devices are all CRT devices coupled with defibrillators. (Id.) Additionally, the InSync pacemaker does not have separate sensing and pacing circuitry for the two ventricular leads; instead, the leads are coupled together. (Id.) Some modes available in the other devices are not found in the InSync ICD. (Id.)

B. Claim Construction

22. The parties dispute construction of ten different terms of the asserted claims of the '119 patent. For the reasons discussed below, the court finds that only two terms, involving claim preambles, are dis-positive of the issues at bar.

1. Legal standard

23. Claim construction is a question of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The words of a claim “are generally given their ordinary and customary meaning,” as understood by a person of ordinary skill in the art in question, read in the context of the particular claim and that of the entire patent, at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.Cir.2005) (citations omitted). The specification “is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996)). It is “entirely appropriate for a court, when conducting claim construction, to rely heavily on the written description for guidance as to the meaning of the claims.” Id. at 1317 “[A] court ‘should also consider the patent’s prosecution history, if it is in evidence.’ ” Id. (quoting Mark-man, 52 F.3d at 980).

24. “[A] claim preamble has the import that the claim as a whole suggests for it. In other words, when the claim drafter chooses to use both the preamble and the body to define the subject matter of the claimed invention, the invention so defined, and not some other, is the one the patent protects.” Bell Commc’ns Research, Inc. v. Vitalink Commc’ns Corp., 55 F.3d 615 (Fed.Cir.1995) (citations omitted). “[T]erms appearing in a preamble may be deemed limitations of a claim when they give meaning to the claim and properly define the invention.” In re Paulsen, 30 F.3d 1475, 1479 (Fed.Cir.1994).

25. “Although no ‘litmus test’ exists as to what effect should be accorded to words contained in a preamble, review of a patent in its entirety should be made to determine whether the inventors intended such language to represent an additional structural limitation or mere introductory language.” Id. “The effect preamble language should be given can be resolved only on review of the entirety of the patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed.Cir.1989) (holding that a preamble reciting “an optical waveguide” was limiting as to the specific type of waveguide taught by the specification, and not to any type, as would be the case without construing the preamble as a limitation). “Whether a preamble of intended purpose constitutes a limitation to the claim is, as has long been established, a matter to be determined on the facts of each case in view of the claimed invention as a whole.” In re Stencel, 828 F.2d 751, 754 (Fed.Cir.1987).

26. “ ‘In considering whether a preamble limits a claim, the preamble is analyzed to ascertain whether it states a necessary and defining aspect of the invention, or is simply an introduction to the general field of the claim.’ ” Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1375 (Fed.Cir.2008) (quoting On Demand Mach. Corp. v. Ingram Indus., 442 F.3d 1331, 1343 (Fed.Cir.2006)). “[W]hen reciting additional structure or steps underscored as important by the specification, the preamble may operate as a claim limitation.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed.Cir.2002). Conversely, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention,” the preamble is not limiting. Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997).

27. Having heard oral argument on, and having reviewed the papers submitted in connection with, the parties’ proposed claim construction, the court construes the disputed claim language consistent with the tenets of claim construction set forth by the Unites States Court of Appeals for the Federal Circuit in Phillips, as follows:

2. Improving the hemodynamic efficiency of a heart

28. The parties dispute whether the preambles of independent claims 15 and 19 of the '119 patent constitute limitations and, if so, their proper construction. The preambles of claims 15 and 19 are identical and recite: “A method for improving the hemodynamic efficiency of a heart comprising the steps of:.... ” At the very outset, the specification of the '119 patent defines an objective of the invention as “a method for increasing the cardiac output of a patient suffering from congestive heart failure,” and points to this objective to distinguish over the prior art. ('119 patent at col. 1:18-22) It is evident from the specification that the invention exists in the context of improving the pumping ability of a heart that is in a state of (congestive) heart failure and, thus, the preambles give meaning to the claims and properly define the invention. The court concludes that the preambles of claims 15 and 19 are limiting, and mean improving the heart’s pumping ability for treatment of congestive heart failure. This construction is consistent with the specification: col. 1:18-22; col. 2:28-33; col. 3:12-15, 32-51; col. 4:23-27.

3. Bi-ventricular pacemaker

29. The preambles of independent claim 25 and of dependent claim 26 of the '119 patent recite, “[a] bi-ventricular pacemaker .... ” Plaintiff argues that this phrase “merely describes the purpose of claims 25 and 26.” (D.I. 147 at 10) Although admitting that these claims require the capability to stimulate two ventricles, plaintiff argues that the language of the claim body alone, without consideration of the preamble, expressly creates this limitation. Claim 25 recites:

A bi-ventricular pacemaker comprising:

detecting means for detecting a cardiac signal resulting from a contraction of a first ventricle;

stimulating means for effecting immediate and unconditional contraction of a second ventricle in response to the detected cardiac signal, thereby effecting simultaneous contraction of both ventricles.

('119 patent at 11:1-7) (emphasis added)

30. Excluding the preamble, claim 25 discloses stimulating means for only one ventricle, the second. It is the preamble, with its term “bi-ventricular pacemaker,” that describes structure capable of stimulating two ventricles. ('119 patent at col. 3:39-55, 6:13-22) Therefore, the court finds that the preamble of claim 25 contains a structural limitation that is not present in the body of the claim and concludes that the preamble of claim 25 constitutes a limitation. A bi-ventricular pacemaker, as used in the preamble of claim 25, means a device capable of providing stimulation to either one or both ventricles to effect a coordinated contraction thereof for the treatment of congestive heart failure. This construction is consistent with the specification: col. 3:32-4:26, col. 6:3-14, col. 7:17-20. Due to its dependency on claim 25, the preamble to claim 26 is similarly construed.

C. Infringement

1. Legal standard

31. To prove direct infringement, the plaintiff must establish by a preponderance of the evidence that one or more claims of the patent read on the accused device literally or under the doctrine of equivalents. See Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 261 F.3d 1329, 1336 (Fed.Cir.2001). To establish literal infringement, “every limitation set forth in a claim must be found in an accused product, exactly.” Southwall Tech., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed.Cir.1995). “If any claim limitation is absent from the accused device, there is no literal infringement as a matter of law.” Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed.Cir.2000). Significant to the case at bar, if an accused product does not infringe an independent claim, it also does not infringe any claim depending thereon. Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed.Cir.1989).

32. To prove infringement by the doctrine of equivalents, a patentee must provide “particularized testimony and linking argument” as to the “insubstantiality of the differences” between the claimed invention and the accused product, or with respect to the function/way/result test. See Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1567 (Fed.Cir.1996).

33. Establishing the literal infringement of a means-plus-function limitation “requires that the relevant structure in the accused device perform the identical function recited in the claim and be identical or equivalent to the corresponding structure in the specification.” Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267 (Fed.Cir.1999). A patentee may show structural equivalence “if the assertedly equivalent structure performs the claimed function in substantially the same way to achieve substantially the same result as the corresponding structure described in the specification.” Id. The Odetics court differentiated between the “similar analysis” of equivalents under the doctrine of equivalents and 35 U.S.C. § 112, ¶ 6, noting that a component by component analysis is not required to establish structural equivalence in the latter. Id. Indeed, such an analysis would be improper to the extent that

[t]he individual components, if any, of an overall structure that corresponds to the claimed function are not claim limitations. Rather, the claim limitation is the overall structure corresponding to the claimed function.... The appropriate degree of specificity is provided by the statute itself; the relevant structure is that which “corresponds” to the claimed function. Further deconstruction or parsing is incorrect.

Id. at 1268 (internal citations omitted). Conversely, the relevant structure does not include “structure ‘unrelated to the recited function’ disclosed in the patent____” Id. (citing Chiuminatta Concrete Concepts, Inc. v. Cardinal Indus., 145 F.3d 1303, 1308 (Fed.Cir.1998)).

2. Burden of proof

34. The parties dispute which side has the burden to prove infringement at trial. Plaintiff argues that the burden is always on the patentee (defendants). (D.I. 193 at 7-9) Defendants assert that the burden of proof was always on Medtronic as plaintiff, and argue three theories in support thereof. First, defendants argue that the Lilly agreement and the LTA provide that Medtronic must file a declaratory judgment action in order to challenge infringement, and that “the plaintiff usually has the burden of proof.” (D.I. 247 at 38) Second, defendants argue that, due to these provisions, the case law cited by plaintiff is inapposite. (Id. at 38-39) Finally, defendants point to this court’s guidelines as to post-trial briefing, establishing that the party having the burden of proof on an issue is usually permitted both an opening brief and a reply brief, whereas the opposing party is usually limited to an answering brief. (Id. at 39) Defendants allege that “Medtronic has taken the unusual position that it does not have the burden of proof but it is entitled to both open and reply on [the issue of infringement].” (Id.)

35. “The burden is always on the patentee to show infringement.” Under Sea Indus., Inc. v. Dacor Corp., 833 F.2d 1551, 1557 (Fed.Cir.1987) (citing Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 758 (Fed.Cir.1984)). “Neither [the patentee’s] burden to prove infringement nor [the accused infringer’s] burden to prove invalidity, both ultimate burdens of persuasion, ever shifts to the other party — the risk of decisional uncertainty stays on the proponent of the proposition.” Technology Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed.Cir.2008) (citing Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1375 (Fed.Cir.1986); Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1574 (Fed.Cir.1985); Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1360 (Fed.Cir.1984)).

36. As the parties asserting infringement, defendants bear the burden of proof by a preponderance of the evidence. See Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed.Cir.1991) (citing Hughes Aircraft Co. v. United States, 717 F.2d 1351, 1361 (Fed.Cir.1983)).

3. Sufficiency of evidence

37. Plaintiff asserts that defendants’ evidence of infringement is insufficient. (D.I. 193 at 9-10) During pre-trial proceedings, plaintiff requested that the court preclude Dr. Berger, defendants’ expert on infringement, from testifying because “he failed to map every element of each asserted claim against the accused Medtronic devices in his expert report.” (D.I. 189 at 327:4-5; D.I. 193 at 9) (citing D.I. 177-2 at 25; D.I. 255 at 116:11-120:3) Pursuant to the court’s order of January 22, 2010 (D.I. 185), plaintiff again raised this issue during trial. (D.I. 189 at 472:2^474:11) The court, at the behest of the parties, reserved judgment on this issue pending post-trial briefing, allowing supplementation of the record. (Id.) In essence, plaintiff has raised a Daubert challenge, claiming that, in opining on infringement, Dr. Berger failed to apply reliable principles and methods to the facts of the case. See Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993).

a. Legal standard

38. The Supreme Court in Daubert made clear that courts have to play a gatekeeping role with respect to experts. Daubert, 509 U.S. at 600, 113 S.Ct. 2786. According to the Supreme Court, Rule 702 of the Federal Rules of Evidence is the primary locus of the gatekeeping role. Pursuant to Rule 702, a party can offer testimony of an expert witness at trial so long as the expert is qualified, the methodology the expert uses is reliable, and the opinion fits the facts of the case. See Elcock v. Kmart Corp., 233 F.3d 734, 741 (3d Cir.2000). A trial judge, then, is tasked with being a “ ‘gatekeeper’ to ensure that ‘any and all expert testimony is not only relevant, but also reliable.’ ” Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir.2008).

39. As recognized by the United States Court of Appeals for the Third Circuit, while an expert’s methodology is required to pass muster under Rule 702, the data underlying the expert’s opinion must pass muster under Rules 104 and 703. More specifically, the Third Circuit in In re Pao li R.R. Yard PCB Litig., 35 F.3d 717 (3d Cir.1994), made clear “that it is the judge who makes the determination of reasonable reliance, and that for the judge to make the factual determination under Rule 104(a) that an expert is basing his or her opinion on a type of data reasonably relied upon by experts, the judge must conduct an independent evaluation into reasonableness.” Id. at 748. The Third Circuit concluded in In re Paoli that, because the policy considerations underlying the rules of evidence are the same, the “reliability requirement” for admission under Rules 104, 702 and 703 should be the same— “there must be good grounds on which to find the data reliable.” Id.

b. Literal infringement

40. Having determined that defendants, as patentees, have the burden to prove infringement, the court recognizes at the outset of its discussion that there are litigation efficiencies in narrowing the issues to be resolved at trial. Therefore, if only certain limitations are in dispute, it makes sense to limit the presentation of evidence to such limitations. In this case, however, it is unclear from the record that there was an agreement among the parties to narrow the issues for trial. Aside from citing to an interrogatory response (DTX-71), it would appear that defendants relied primarily on their burden-shifting view of the case, thus leaving the court between a rock (the way the parties chose to litigate this case) and a hard place (the court’s responsibility to make an infringement determination based on appropriate evidence). Because plaintiff has asserted consistently that Dr. Berger failed to conduct an appropriate infringement analysis in his expert report, through his deposition and at trial, and because there is no affirmative evidence excusing Dr. Berger from this responsibility, the court will review the record to test the sufficiency of defendants’ infringement analysis in this regard.

41. In its post-trial brief, plaintiff points to Dr. Berger’s deposition testimony in support of its argument that “his expert report did not map every element of each asserted claim against each accused product.”

Q. Okay. And you understand that in undertaking an infringement analysis what you do is map each element of the asserted claim against the accused products; right?

A. Correct.

Q. Okay. In this case you did not do that for each limitation of the asserted claims; correct?

A. I believe I did do that.

Q. Okay. Well let’s take a look at your report. As an example if we could turn to page 56, and section O of your report is dealing with the '897 patent, Claim 217. Do you see that?

A. Yes.

Q. Okay. And what follows is your analysis with respect to that claim; correct?

A. I believe so, yes.

Q. Okay. And in fact there are certain limitations in Claim 217 for which you did not map it to the accused products; correct, doctor?

A. Let me read the—

Q. Sure.

A. —section. (Witness reviewing exhibit.) Well in this section here in the — in the area of this report it does not list my opinions on each of the claims limitations, correct.

Q. And in fact what you did, doctor, was respond to certain limitations that were addressed in the report of Dr. Love; correct?

A. I believe that’s — -I believe that was the philosophy that I took here, yes.

Q. Okay. So you didn’t in fact independently map each asserted limitation onto the accused devices; correct, doctor?

A. In this — In this report that’s correct.

(D.I. 193 at 910) (citing D.I. 193, ex. A at 7:11-8:21)

42.Plaintiff supplemented the record with a video clip on CD media (id., ex. B) purporting to show that “Dr. Berger’s admissions were not ‘off the cuff or made under time restraints. Dr. Berger carefully and deliberately reviewed his expert report for seven minutes before admitting that he failed to map the claims to the products.” (D.I. 193 at 10) Plaintiff further asserts that, “[i]n addition, in their original pre-trial submission of Exhibit 5 to the Joint Pretrial Order to Medtronic, [defendants admitted that Dr. Berger did not address each claim limitation, stating that ‘Dr. Berger was not required to map every element of each claim.’” (Id.) (citing id., ex. C at 2)

43. Dr. Berger’s expert report on infringement (D.I. 148, ex. 2, “Berger report”) covers combinations of 27 claims of two patents asserted against nine accused products, and comprises 72 pages. The Berger report does not contain or reference a typical infringement analysis chart whereby each element of each asserted claim is individually compared with each accused product. Plaintiff does not assert that such a chart is required to prove infringement, although it would have certainly aided the court’s determination of whether Dr. Berger’s analysis met the required standard. Instead, Dr. Berger provides only a narrative discussion of various claim limitations, organized to be responsive to Dr. Love’s expert report on non-infringement. (D.I. 148, ex. 1)

44. Dr. Berger’s analysis of claim 15 of the '897 patent serves as an example of the issue at bar. That claim recites, as the first of three limitations after the preamble, “a sense amplifier to receive ventricular depolarization signals originating from a first ventricle.” Dr. Berger’s analysis of the entire claim is limited to a recitation of the full claim language, followed by:

It is my opinion that each of Medtronic’s cardiac resynchronization systems marketed under the names InSync, InSync II Marquis, InSync II Protect, InSync Sentry, InSync Maximo, Concerto, Consulta and Maximo II delivers a stimulating pulse to the ventricles in response to a ventricular sense for the reasons discussed above in Section V(A)(3) [sic], or does not operate substantially differently than a device that operates in this manner.

(D.I. 148, ex. 2 at 47-48, § VI(G)) Section VI(A)(3) (id., at 30-31), in turn, is a narrative analysis of claim 15 of the '119 patent relating to the limitation, “stimulating both ventricles ... when a cardiac depolarization signal originating from a first ventricle is detected.” The court is unable to locate any reference to the term “sense amplifier” in section VI(A)(3). Section VI(A)(3) has a further reference to unspecified preceding sections relating to the WT mode and VSR feature. The court is also unable to locate any consideration of the “sense amplifier” limitation in preceding sections. Moreover, it is not incumbent on the court to do so.

45. Dr. Berger similarly performs his analysis of claims 54, 84, 86, 120, and 144 of the '897 patent and others. Only vague perfunctory language potentially covers the remaining elements of asserted claims. Defendants’ argument that they need only address elements identified in plaintiffs response to its interrogatories or in Dr. Love’s non-infringement report (collectively “non-infringement defense”) is inapposite as it does not address the issue at bar, whether Dr. Berger’s testimony lacks sufficient foundation..

46. The Berger report fails to demonstrate that Dr. Berger considered each limitation of each asserted claim in comparison to each accused product before rendering his infringement opinions. Plaintiffs non-infringement defense, even if considered an admission, would not relieve Dr. Berger of this requirement absent affirmative evidence to this effect. There is no way to determine if “every limitation set forth in a claim is found in an accused product, exactly,” without accounting for each limitation. Any such admission would merely render that task easier to accomplish. Defendants have failed to prove literal infringement by a preponderance of the evidence.

c. Doctrine of equivalents

47. Plaintiff contends that Dr. Berger’s doctrine of equivalents analysis consists solely of conclusory statements, and fails to provide particularized testimony and linking arguments required to sufficiently prove infringement under this doctrine. (D.I. 193 at 27-28) (citing id., ex. D at 19-23, 23-26, 31-33, 34-35, 36-39)

48. Defendants’ argument regarding doctrine of equivalents is subsumed in their term-by-term rebuttal to plaintiffs non-infringement defenses. (D.I. 247 at 34, ¶ 9) Defendants argue, for example, with respect to the term “contractions” and the doctrine of equivalents that

Dr. Mower’s invention is directed to resynchronization of the ventricles and not to any particular manner in which a contraction is sensed (by electrical or mechanical sensing). Therefore, the resynchronization would take place using either form of sensing. Accordingly, the difference would be “insubstantial.” As explained by Dr. Berger, “[t]he difference would not be substantial at all. The purpose is the same, to detect when the atria are activated.”

(D.I. 247 at 24) (citing D.I. 189 at 342:9— 13; D.I. 192 at 983:7-18; D.I. 246, ex. D, D.I. 148, ex. 2, at 31-33)

49. The Federal Circuit has explained that its “prior cases stand for the proposition that mere generalized testimony as to equivalence is insufficient as a matter of law to support a [ ] verdict finding infringement under the doctrine of equivalents.” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182 (Fed.Cir. 1998). “ ‘Generalized testimony as to the overall similarity between the claims and the accused infringer’s product or process will not suffice [to show infringement under the doctrine of equivalents].’ ” Id. (