Full opinion text
FINDINGS OF FACT, CONCLUSIONS OF LAW, AND ORDER ON DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT OF NONIN-FRINGEMENT HERNDON, Chief Judge: This matter came before the Court on the Motion, pursuant to Rule 56 of the Federal Rules of Civil Procedure, by Cordis Corporation and Johnson & Johnson (collectively “Cordis”) for Summary Judgment of Noninfringement of U.S. Patent Nos. 7,128,753 (“the '753 patent”) and 7,217,290 (“the '290 patent”) (collectively “the patents-in-suit” or “Bonutti patents”). D.I. 68. After consideration of that motion and subsequent briefing (D.I. 108, D.I. 125), the Court makes the following findings of fact, based on the Court’s claim construction and facts over which there is no dispute or can be no dispute as a matter of law, as well as, conclusions of law. FINDINGS OF FACT 1. On July 18, 2008, Cordis moved for summary judgment of noninfringement. D.I. 68. 2. On March 31, 2009, 2009 WL 910200, this Court issued an opinion and order construing disputed claim language from the '753 and '290 patents consistent with the specification and the prosecution history. D.I. 175. Cordis’s motion for summary judgment of noninfringement concerns limitations that were construed in that opinion. 3. In order to demonstrate that the Cypher stent infringes the patents-in-suit under the Court’s claim construction, MarcTec would need to show, inter alia, that: (1) Cypher is a surgical device or implant, (2) only a portion of the Cypher stent is expandable, (3) the polymers in Cypher’s drug-eluting coating do not adhere to the stent at room temperature, (4) the polymers in Cypher’s drug-eluting coating are bonded to the device by the application of heat, and (5) “that heat must be sufficient to cause the material to be bonded to become flowable, tacky and adherent.” D.I. 175 at 28; see also id. at 23, 26, 29. I. The Asserted Patents A. The Claims of the '290 Patent 4. In this action, plaintiff MarcTec L.L.C. (“MarcTec”) alleges that the Cypher stent, sold by defendant Cordis, infringes claims 1-6, 8, 10 and 14 of the '290 patent. Claim 1 is an independent claim. Claims 2-6, 8, 10 and 14 depend from claim 1 and thus incorporate all of its limitations. 5. Claim 1, with the five limitations which are the basis for Cordis’s Motion for Summary Judgment of Noninfringement in bold italics and numbered, reads as follows: [1] An implant for implantation in a human body comprising: a tubular member having a channel and mechanically expandable upon activation of a delivery mechanism from a contracted condition in which the tubular member has a first cross sectional size in a plane perpendicular to a longitudinal central ax is of the tubular member to an expanded condition in which [2] at least a portion of the tubular member has a second cross sectional size in a plane perpendicular to the longitudinal central ax is of the tubular member, the second cross sectional size being larger than the first cross sectional size to thereby lock the tubular member against tissue in the human body; and [3] a ñrst component bonded to at least a portion of the tubular member and formed of a heat bondable material that includes a therapeutic agent selected from the group consisting of a tissue ingrowth promoter and an antibiotic, wherein the heat bondable material is [4] non-flowable and non-adherent at room temperature and [5] becomes ñowable, tacky, and adherent upon the application of heat. B. The Claims of the '753 Patent 6. MarcTec also alleges that the Cypher stent infringes claims 1, 3 and 4 of the '753 patent. Claims 3 and 4 depend from independent claim 1 and thus incorporate all of its limitations. 7. Claim 1, with the five limitations which are the basis for Cordis’s motion for summary judgment in bold italics and numbered, reads as follows: [1] A surgical device for implantation in a body comprising: an [2] implant, at least a portion of which is expandable; and [3] a polymeric material bonded to the implant, wherein the polymeric material is a thermoplastic, includes a therapeutic agent, is [4] nonñowable and non-adherent at room temperature, and [5] becomes flow able, tacky, and adherent upon the application of heat. II. Prosecution History 8. Dr. Peter Bonutti is a named inventor on both of the patents-in-suit. 9. As the Court previously found, during prosecution of the patents-in-suit, the Patent Office (“PTO”) rejected Dr. Bonutti’s proposed claims as invalid over U.S. Patent No. 5, 102,417 (“the '417 patent”), which issued to Dr. Julio Palmaz. D.I. 175 at 9; D.I. 70, Ex. L at 3. Dr. Palmaz is the inventor of the balloon-expandable coronary stent. D.I. 175 at 9; D.I. 125, Ex. 2 (Denardo Tr.) 30:14-19. In his early patents, including the '417 patent — written before balloon-expandable stents existed— Dr. Palmaz used the terms “expandable intraluminal vascular graft” and “expandable prosthesis” to refer to stents. D.I. 175 at 9; D.I. 70, Ex. G (Palmaz '417 patent) at 5:26-35, 6:44-54. 10. In the '417 patent, Dr. Palmaz makes a point of distinguishing intraluminal procedures utilizing stents from conventional surgery. D.I. 175 at 9; D.I. 70, Ex. G at 1:26-35. 11. The Palmaz '417 patent is prior art to the patents-in-suit and teaches a polymer/drug coating “placed upon the wall surfaces” of the stent. D.I. 70, Ex. G at 11:3-8,11:26-34; D.I. 175 at 9. 12. As this Court has found (D.I. 175 at 9-10), when the PTO rejected Dr. Bonutti’s claims as invalid over the Palmaz stent (D.I. 70, Ex. L at 3), Dr. Bonutti represented to the PTO — and thus the public— that his invention did not include intraluminal grafts (ie., stents), and, further, that his invention is directed to devices for use in surgical applications, in contrast to Palmaz’s balloon-expandable stent, which is not a surgical device: Palmaz discloses an expandable intraluminal vascular graft, or expandable prosthesis for a body passageway (col. 6., Ins. 21-23)____ Applicants, on the other hand, disclose, inter alia, an assembly for use in surgical applications in humans. D.I. 70, Ex. M at 5. 13. In addition, Dr. Bonutti represented to the PTO that his invention is different from the device disclosed by Dr. Palmaz because his invention, unlike the device described by Dr. Palmaz, has a material bonded to it by the application of heat. D.I. 175 at 10; D.I. 70, Ex. M at 6. Thus, Dr. Bonutti represented to the PTO that “[i]n contrast [to the device disclosed by Dr. Palmaz], Applicants’ implant includes a heat bondable material which is bonded to an implant by the application of heat.” D.I. 70, Ex. M at 6 (emphasis added); D.I. 175 at 10. In his '417 patent, Dr. Palmaz does not disclose the use of heat to bond the coating to the stent. D.I. 175 at 10. Dr. Bonutti relied on this difference to differentiate his invention from the prior art Palmaz patent, and, thus, to obtain allowance of his claims. Id.; D.I. 70, Ex. M at 6. As this Court has held, in doing so, “Dr. Bonutti disclaimed devices in which a material is bonded to the device other than by the application of heat.” D.I. 175 at 10; see id. at 23. 14. Dr. Bonutti also amended the claims of the patents-in-suit to require that the material bonded to the implant or tubular member “is non-flowable and nonadherent at room temperature and becomes flowable, tacky, and adherent upon the application of heat.” D.I. 175 at 10-11; D.I. 70, Ex. M at 2; D.I. 70, Ex. O at 2. 15. The amendment was made in direct response to the Examiner’s rejection of the claims as anticipated by the disclosure of a coating with drug “placed upon wall surfaces of tubular shaped members” in the prior art Palmaz patent. D.I. 70, Ex. M at 5-6; D.I. 70, Ex. G at 11:3-8, 11:26-34; D.I. 175 at 11. 16. Dr. Bonutti told the PTO that the purpose of his amendment was to “highlight” the distinction between his invention and the prior art Palmaz patent: Palmaz teaches an implant including an absorbable polymer coating placed upon wall surfaces of tubular shaped members. In contrast, Applicant’s implant includes a heat bondable material which is bonded to an implant by the application of heat. To highlight this distinction, Applicants have amended independent claims 11 and 27 to include, inter alia, a polymer material which is non-flowable and non-adherent at room temperature and becomes flowable, tacky, and adherent upon the application of heat. D.I. 70, Ex. M at 6. 17. As this Court has explained, “this amendment made clear that Dr. Bonutti’s invention required the application of heat to a heat bondable material to cause that material to transform from one state (nonflowable and non-adherent) to a different state (flowable, tacky and adherent).” D.I. 175 at 11. III. Claim Construction 18. In moving for summary judgment of noinfringement, Cordis asserts that undisputed evidence establishes that its Cypher stent does not have several claim limitations of the Bonutti patents, as construed by this Court in its March 31, 2009 claim construction opinion and order (D.I. 175). A. Mechanical Claim Limitations 19. As construed by this Court, the claims of the patents-in-suit exclude stents. D.I. 175 at 19. Specifically, the Court has construed the terms “a surgical device” from claim 1 of the '753 patent and “an implant” from claim 1 of the '290 patent to mean “a device for use in surgical applications, but not including an expandable intraluminal vascular graft or expandable prosthesis for a body passageway.” Id. 20. The Court also construed the language of the claims as covering devices that expand in part, not completely. Id. at 20. Specifically, the Court construed the language “an implant, at least a portion of which is expandable” from claim 1 of the '753 patent to mean that “a portion, but not all of the implant, is expandable.” Id. at 20. In addition, the Court construed the language “a tubular member ... mechanically expandable ... from a contracted condition ... to an expanded condition in which at least a portion of the tubular member has a second cross sectional size ... larger than the first cross sectional size to thereby lock the tubular member against tissue in the human body” from claim 1 of the '290 patent to mean that “a portion, but not all, of the tubular member is expandable so that when expanded, its cross-sectional size is larger than its initial cross-sectional size. The expansion of only a portion of the tubular member enables it to be locked against tissue.” Id. B. Claim Limitations Requiring Heat 21. As construed by this Court, the claims of the patents-in-suit require heat to cause the polymeric material to bond to the implant. Id. at 26-29. 22. The Court construed the phrase “a polymeric material bonded to the implant” from claim 1 of the '753 patent to mean “a polymeric material is bonded to the implant by the application of heat.” Id. at 26. The Court construed the phrase “a first component bonded to at least a portion of the tubular member” from claim 1 of the '290 patent to mean “a material is bonded to the tubular member by the application of heat.” Id. 23. The Court construed the phrase “the polymeric material ... is non-flowable and non-adherent at room temperature” from claim 1 of the '753 patent to mean that “the polymeric material cannot flow at room temperature and cannot adhere to the implant if placed on the implant at room temperature.” Id. at 27. In addition, the Court construed the phrase “the heat bondable material is non-flowable and non-adherent at room temperature” from claim 1 of the '290 patent to mean that “the heat bondable material cannot flow at room temperature and cannot adhere to the tubular member if placed on the tubular member at room temperature.” Id. at 27-28. 24.The Court construed the phrase “the polymeric material ... becomes flow-able, tacky and adherent upon the application of heat” from claim 1 of the '753 patent to mean that “the polymeric material is bonded to the implant by the application of heat sufficient to cause the polymeric material to become flowable, tacky and adherent.” Id. at 28-29. In addition, the Court construed the phrase “the heat bondable material ... becomes flowable, tacky and adherent upon the application of heat” from claim 1 of the '290 patent to mean that “the heat bondable material is bonded to the tubular member by the application of heat sufficient to cause the heat bondable material to become flowable, tacky and adherent.” Id. at 29. IV. Cordis’s Cypher Stent A. The Cypher Stent And Its Mechanical Properties 25. In this action, MarcTec alleges that Cordis’s Cypher stent infringes the asserted claims of the '290 and '753 patents. The Cypher stent is a balloon-expandable drug-eluting stent. It is a small, slotted metal tube with a coating of polymers and drug adhered on its outer and inner surfaces. D.I. 70, Ex. X; D.I. 70, Ex. W at CMT16148. 26. The Cypher stent is introduced into a blood vessel by percutaneous (through the skin) insertion and delivered via a balloon catheter to the desired location in a coronary artery. The placement of the stent (or stenting) is a “non-surgical” procedure. D.I. 70. Ex. S at CMT510697. As this Court has found, a stent is a “nonsurgical” device. D.I. 175 at 4. 27. The stent is premounted on a balloon catheter in a contracted form and introduced in the body in this form. D.I. 70, Ex. Y at CMT1437997. Once the Cypher stent is positioned at a site of the blockage, the balloon is inflated and the stent fully expanded along its entire length. Id. After the Cypher stent is expanded by the balloon, it stays fully expanded. The balloon is then deflated and removed with the stent remaining in place. The expanded Cypher stent acts as a scaffold to keep the artery open and allow blood flow. Id. B. The Cypher Drug-Eluting Coating 28. Cypher’s polymer/drug coating (or drug-eluting coating) has three components: two polymers and a drug. D.I. 70, Ex. W at CMT16148; D.I. 68, Ex. 1 Declaration of Cynthia A. Maryanoff, Ph.D. (“Maryanoff Decl.”) ¶ 6. The polymers are poly-n-buryl methacrylate (“PBMA”) and poly(ethylene-co-vinyl acetate) (“PEVA”). The drug is sirolimus. D.I. 70, Ex. W at CMT16148; D.I. 68, Ex. 1 (Maryanoff Decl.) ¶ 6. 29. The technology used to place this polymer/drug coating on the wall surfaces of a stent is known as solution casting. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶ 7. Solution casting is a method of applying a material to a surface by first dissolving the material in a solvent, applying the mixture to a surface and allowing the solvent to evaporate, thus leaving the material behind, adhered to the surface. Id. at ¶ 8. Solution casting has been known for centuries. It is how paint is applied to a surface, by mixing pigment in a solvent, applying the mixture to the surface and allowing the solvent to evaporate. Paint dries as the solvent evaporates. Once the solvent evaporates, the pigment is adhered to the surface. Id. The Cypher stent is coated in exactly the same way. Id. 30. Before the polymer/drug coating is applied, the stent surface is first prepared with a silane reagent followed by the deposition of a Parylene C primer coat. Id. at ¶ 9. The polymers, PBMA and PEVA, and drug, sirolimus, are dissolved in a solvent. This solution is then sprayed on the surface of the primed stent. The polymer/drug coat is left on the surface once the solvent evaporates and adheres to that surface. Id. The placing of polymers and drug on the Cypher stent occurs entirely at room temperature. No heating is involved in placing the polymers and drugs on the stent. Id. at ¶ 10. i. Applying the Base Coat and Top Coat Solutions 31. The polymer/drug coat is applied by first spraying what is called a base coat solution onto a Parylene C-coated stent. The base coat solution is a 1:1:1 mixture of PBMA, PEVA and sirolimus dissolved in tetrahydrofuran (“THF”), a solvent. Id. at ¶¶ 9,11. 32. The base coat solution is sprayed onto the stent using a spraying device, similar to a spray gun. Id. at ¶ 11. Both the base coat solution and the spraying of the base coat solution are at room temperature. Id. 33. The stents are coated in a room where the normal room operating range is 17°C-24°C (64°F-76°F). Id. at ¶ 12; Ex. B at 10 to D.I. 68, Ex. 1 (Maryanoff Decl.). If the temperature in the coating facility drops below 15°C (60°F) or exceeds 26°C (80°F), the coating operation is “shut down.” D.I. 68, Ex. 1 (Maryanoff Decl.) ¶ 12; Ex. B at 10 to D.I. 68, Ex. 1 (Maryanoff Decl.). 34. The sprayed stent is air dried for thirty minutes or more at room temperature. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶ 13. This air drying process allows the solvent to evaporate, leaving the polymer/drug coating adhered to the stent at room temperature. Id.; see also D.I. 108, Ex. 2 Expert Report of Christopher Batich, Ph.D. (“Batich Rpt.”) ¶ 57 (“[d]uring the drying step, the solvent evaporates from the stent surface, leaving the polymers on the stent”); id. at ¶¶ 113 (“as the solvent evaporates from the stent, the polymers become adhered to the stent.”). 35. The stent is then weighed to ensure that the FDA-approved amount of polymers and drug has adhered to the stent. D.I. 68, Ex. 1 (Maryanoff Dec.) ¶ 15. The stent weight would not be representative of the correct dosage of drug for patients if the polymer/drug coating had not adhered to the stent and did not remain adhered for the remainder of manufacture. Id. at ¶ 16. After being weighed, a top coat solution is applied over the polymer/drug coating. Id. at ¶ 17. 36. The top coat solution consists of PBMA dissolved in THF. Id. As with the base coat application, the top coat solution is at room temperature when it is sprayed onto the stent and the spraying occurs at room temperature. Id. at ¶ 18. 37. The stent is then sprayed with toluene. Like THF, toluene is a solvent for PBMA, PEVA and sirolimus. Both the toluene and the spraying of the toluene are at room temperature. After the toluene is sprayed onto the stent, the stent is allowed to air dry at room temperature. Id. at ¶ 19. 38. Once the air drying process is complete, the polymer/drug coating is adhered to the Cypher stent. Because the coating has dried and adhered at room temperature, it can be handled. Id. at ¶ 20. 39. The stents are then visually inspected and manicured if necessary with a sharp cutting tool to remove any irregularities or defects in the polymer/drug coating. The stents are then weighed again to determine if the polymer/drug coating on the stent conforms to FDA requirements. This step is critical to ensure that patients receive the correct dosage of drug. Id. at ¶¶ 22-24. 40. All coated stents that conform to the drug-content specifications are crimped (attached by reducing the stent diameter) under pressure on a balloon catheter that ultimately delivers the stent to the diseased vessel. Id. at ¶ 25. 41. MarcTec’s expert, Dr. Batich, admits the entire coating process for the Cypher stent occurs at room temperature. D.I. 125, Ex. 3 (Batich Tr.) 156:17-22, 177:13-178:3, 209:3-20; see also id. at 154:13-155:2,180:7-17. ii. Sterilization 42. The stents are sterilized using a “low temperature ethylene oxide sterilization” process that was specially developed for Cordis’s drug-containing products. Id. at ¶ 29; see also Ex. D at 1 to D.I. 68, Ex. 1 (Maryanoff Deck). 43. Sirolimus is a sensitive drug and heat accelerates its degradation. Id. at D.I. 68, Ex. 1 (Maryanoff Deck) ¶ 30. Accordingly, Cordis uses a low temperature sterilization process for Cypher. Id. at ¶ 31. 44. The stents are sterilized in a sterilization chamber set at 30°C-35°C (86°F-95°F). Id. at ¶ 31; see also Ex. D at 1 to D.I. 68, Ex. 1 (Maryanoff Deck); D.I. 125, Ex. 3 (Batich Tr.) 148:20-22, 151:10-18. 45. Apart from the vacuum heating process used for stents sold in Japan, the sterilization process is the only time that the Cypher drug-eluting coating is exposed to temperatures above room temperature. D.I. 125, Ex. 3 (Batich Tr.) 152:2-14, 156:17-22; D.I. 68, Ex. 1 (Maryanoff Deck) ¶ 33. 46. Sterilization is conducted to sterilize the product, not to cause the polymer/drug coating to adhere. D.I. 68, Ex. 1 (Maryanoff Deck) at ¶ 34. Indeed, the Cypher coating has adhered to the stent well prior to sterilization and, thus, prior to any exposure to the temperatures used during the sterilization process. Id.; see also D.I. 125, Ex. 3 (Batich Tr.) 94:9-23, 95:8-13,155:3-156:8. 47. The temperatures used during sterilization do not cause the polymers in Cypher’s drug-eluting coating (PBMA and PEVA) to change their state so as to flow or become tacky. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶¶ 36, 39. Instead, the Cypher stent is sterilized at temperatures lower than the temperature in the human body, i.e. 37°C (98.6°F), where the stent is used. Id. at ¶ 32; D.I. 125, Ex. 3 (Batich Tr.) 151:10-18 (agreeing that “in practice, during sterilization of Cypher drug-eluting stents for the last two years, the temperature during sterilization has never exceeded 35 degrees Celsius.”). 48. Cypher would have to be exposed to temperatures above 62°C (144°F) for these polymers to change their state and become flowable and tacky. D.I. 68, Ex. 2 Declaration of Robson F. Storey, Ph.D. (“Storey Decl.”) ¶ 7; D.I. 108, Ex. 2 (Batich Rpt.) ¶¶ 72-73, 75-76, 103-105, Ex. H. Dr. Batich found that PEVA had to be exposed to a temperature of 70°C or above in order to become flowable, tacky and adherent due to heat. D.I. 125, Ex. 3, 107:6-12; see also D.I. 108, Ex. 2 (Batich Rpt.) ¶¶ 72-73, 103-105, Ex. H. The PEVA and PBMA polymers in Cypher’s drugeluting coating are never exposed to such temperatures. D.I. 125, Ex. 3 (Batich Tr.) 152:2-14 (agreeing that “the highest temperature during the Cordis manufacturing process that either the Cypher stent sold in the U.S. or the OUS markets are subjected to is 35 degrees Celsius” and that “the highest temperature that the Cypher stents designated for the Japanese market are exposed to is 45, plus or minus 5 degrees Celsius.”); see also D.I. 68, Ex. 1 (Maryanoff Decl.) ¶¶ 31, 33. 49. As a result, it is not scientifically possible for the polymers in Cypher to be bonded to the Cypher stent by the application of heat and, in fact, the polymers are not bonded to the Cypher stent by the application of heat. D.I. 114, Ex. 9 Rebuttal Expert Report of Robson F. Storey, Ph.D. (“Storey R. Rpt.”) at 33. They are applied and adhere to the stent at room temperature. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶¶10, 13, 20-21; D.I. 125, Ex. 3 (Batich Tr.) 154:13-155:2,156:17-22,177:2-180:17, 209:3-20. CONCLUSIONS OF LAW I. Literal Infringement 1. Summary judgment is just “as appropriate in a patent case as in any other.” Barmag Banner Maschinenfabrik AG v. Murata Mach., Ltd., 731 F.2d 831, 835 (Fed.Cir.1984); Nike, Inc. v. Wolverine World Wide, Inc., 43 F.3d 644, 646 (Fed. Cir.1994). 2. “A determination of patent infringement requires a two-step analysis. The court must first interpret the claims to determine their scope and meaning. It must then compare the properly construed claims to the allegedly infringing device.” PSC Computer Prods., Inc. v. Foxconn Int'l Inc., 355 F.3d 1353, 1357 (Fed.Cir. 2004) (citing Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed.Cir.1998) (en banc)). 3. The first step is an issue of law for the court; the second step is an issue of fact. Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed.Cir.2000). However, “[wjhere the parties do not dispute any relevant facts regarding the accused product, ... [and merely] disagree over possible claim interpretations, the question of literal infringement collapses into claim construction and is amenable to summary judgment.” General Mills, Inc. v. Hunt-Wesson, Inc., 103 F.3d 978, 983 (Fed.Cir.1997). 4. The burden of proving patent infringement falls on the patentee. PSC, 355 F.3d at 1357; Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1046 (Fed.Cir.2001). The patentee must prove that “all of the elements of the [asserted] claim, as correctly construed, [are] present in the accused” product. TechSearch, L.L.C. v. Intel Corp., 286 F.3d 1360, 1371 (Fed.Cir .2002). 5. There are two types of patent claims: independent claims and dependent claims. It is “a fundamental principle of patent law that ‘dependent claims cannot be found [to be] infringed unless the claims from which they depend have been found to have been infringed.’ ” Jeneric/Pentron, Inc. v. Dillon Co., 205 F.3d 1377, 1383 (Fed.Cir.2000) (quoting Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed.Cir.1989)). II. The Doctrine of Equivalents 6. An accused device that does not literally infringe may still be found to infringe under the doctrine of equivalents (“DOE”) “if only ‘insubstantial differences’ distinguish the missing claim element from the corresponding aspects of the accused device.” Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1423 (Fed.Cir. 1997). 7. “Whether equivalency exists may be determined based on the ‘insubstantial differences’ test or based on the ‘triple identity’ test, namely, whether the element of the accused device ‘performs substantially the same function in substantially the same way to obtain the same result.’ ” TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc., 529 F.3d 1364, 1376 (Fed.Cir. 2008) (citation omitted). 8. As with literal infringement, the patentee bears the burden of proof on the DOE. PSC, 355 F.3d at 1357. 9. The DOE cannot be used to recapture structures “specifically excluded” from the scope of the claims during claim construction. Decisioning.com, Inc. v. Federated Dep’t Stores, Inc., 527 F.3d 1300, 1315 (Fed.Cir.2008) (collecting cases). 10. Prosecution history estoppel bars the assertion of the DOE when (1) the patentee clearly and unmistakably surrenders subject matter by arguments made to the examiner (argument-based estoppel) or (2) makes a narrowing amendment for purposes of patentability (amendment-based estoppel). Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 736, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002); Pharmacia & Upjohn Co. v. Mylan Pharms., Inc., 170 F.3d 1373, 1376 (Fed.Cir.1999). 11. Argument-based estoppel precludes a patentee from obtaining the equivalent for subject matter relinquished during prosecution. Pharmacia, 170 F.3d at 1376; Bayer, 212 F.3d at 1253. The arguments must evince a clear and unmistakable surrender of subject matter in order for there to be an estoppel. Pharmacia, 170 F.3d at 1377; KCJ Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351, 1359 (Fed.Cir.2000). 12. Amendment-based estoppel precludes application of the DOE where an amendment is made for reasons of patent-ability and narrows the scope of the claim. Festo Corp., 535 U.S. at 727, 122 S.Ct. 1831; Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1366 (Fed.Cir.2003) (en banc). 13. Once it has been determined that the narrowing amendment has been made for a reason related to patentability, it is presumed that “the patentee has surrendered all territory between the original claim limitation and the amended claim limitation.” Festo, 344 F.3d at 1367; Festo, 535 U.S. at 740, 122 S.Ct. 1831. III. Role of Expert Testimony 14. “Under modern summary judgment law, a patentee who fails to provide probative evidence of infringement runs the risk of being peremptorily nonsuited.” Novartis, 271 F.3d at 1050-51 (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986)). “[A] party does not meet this evidentiary threshold merely by submitting the affidavit of an expert who opines that the accused device meets the claim limitations.” Novartis, 271 F.3d at 1051. 15. “It is well settled that an expert’s unsupported conclusion on the ultimate issue of infringement is insufficient to raise a genuine issue of material fact, and that a party may not avoid that rule simply by framing the expert’s conclusion as an assertion that a particular critical claim limitation is found in the accused device.” (Dynacore Holdings Corp. v. U.S. Philips Corp., 363 F.3d 1263, 1278 (Fed.Cir.2004)); see also Moore U.S.A., Inc. v. Standard Register Co., 229 F.3d 1091, 1112 (Fed.Cir. 2000) (finding conclusory declarations alleging infringement of accused devices insufficient to carry patentee’s burden of proving infringement, both literally and under the doctrine of equivalents); Zelinski v. Brunswick Corp., 185 F.3d 1311, 1317 (Fed.Cir.1999) (same); Phillips Petroleum Co. v. Huntsman Polymers Corp., 157 F.3d 866, 876 (Fed.Cir.1998) (same). 16. Rather, “the expert must set forth the factual foundation for his opinion ... in sufficient detail for the court to determine whether that factual foundation would support a finding of infringement under the claim construction adopted by the court, with all reasonable inferences drawn in favor of the nonmovant.” Novartis, 271 F.3d at 1051 (quoting Arthur A. Collins, Inc. v. N. Telecom Ltd., 216 F.3d 1042, 1047-48 (Fed.Cir.2000)). 17. Expert opinions under an incorrect claim construction have no relevance. PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1246 (Fed.Cir.2002); Liquid Dynamics Corp. v. Vaughan Co., 2004 WL 2260626, at *4-5 (N.D.Ill. Oct. 1, 2004) (excluding expert testimony that did not conform to the correct claim construction). Such evidence does not assist the trier of fact and is inadmissible. IV. The Cypher Stent Does Not Meet the Claim Terms Requiring a Surgical Implant and a Device at Least a Portion of Which is Expandable 18. All of the asserted claims of the '290 patent require “an implant” for implantation in a human body. All of the asserted claims of the '753 patent require “a surgical device” for implantation in a body. 19. Under the Court’s construction of these claim terms stents, are excluded from the scope of the claims, D.I. 175 at 19, and the Cypher stent cannot infringe either patent as a matter of law. See, e.g., K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1366-69 (Fed.Cir.1999) (affirming grant of summary judgment of no literal infringement where the only issue is claim construction); General Mills, 103 F.3d at 983-85 (same). A. Cypher is a Stent, Not a Surgical Device 20. The terms “a surgical device” from claim 1 of the '753 patent and “an implant” from claim 1 of the '290 patent have both been construed to mean “a device for use in surgical applications, but not including an expandable intraluminal vascular graft or expandable prosthesis for a body passageway.” D.I. 175 at 19. 21. Under this claim construction, “expandable intraluminal vascular grafts,” i.e., stents, are excluded from the scope of the claims because Dr. Bonutti disclaimed such devices in order to obtain allowance of his patents. Id. at 9-10,16. 22. MarcTec does not dispute that Cypher is a stent. Rather, it contends that stents are covered by the claims even though the Court construed the terms “surgical implant” and “implant” to exclude the “expandable intraluminal vascular grafts” that Dr. Palmaz disclosed and Dr. Bonutti disclaimed. D.I. 108 at 9-12; see also MarcTec’s Responses to Defendants’ Proposed Findings of Fact and Conclusions of Law and Counter-Statement of Facts in Support of MarcTec’s Opposition to Defendants’ Motion for Summary Judgment (“PI. Resp.”) at page 30. 23. MarcTec contends that Dr. Palmaz’s “expandable intraluminal vascular graft” and “expandable prosthesis for a body passageway” is not a stent. D.I. 108 at 11-12; see also Pl. Resp. at page 30. MarcTec also claims that an “expandable prosthesis for a body passageway” supposedly is “not for inclusion in a blood vessel, and thus cannot be a coronary stent.” D.I. 108 at 12 n. 11; Pl. Resp. at page 31. This mischaracterizes Dr. Palmaz’s invention, and is in conflict with admissions from MarcTec’s own witnesses. 24. MarcTec’s expert cardiologist, Dr. Denardo, admits that “just like a coronary stent, both the intraluminal vascular graft and the expandable prosthesis of the '417 patent can be used in a blood vessel.” D.I. 125, Ex. 2 (Denardo Tr.) 84:2-10; see also id, at 78:21-79:16, 83:8-23. 25. As already recognized by the Court, Dr. Palmaz, the inventor of the balloon-expandable stent, used the terms “intraluminal vascular graft” and “expandable prosthesis” in the '417 patent to refer to his invention of the balloon-expandable stent. D.I. 175 at 9,16. 26. The Federal Circuit and other district courts have recognized that the device disclosed in the Palmaz '417 patent (and in the Palmaz 4,739,762 patent (“'762 patent”) from which it claims priority), which was disclaimed by Dr. Bonutti during the prosecution of the patents-in-suit, is a stent. E.g., Cordis Corp. v. Medtronic Ave, Inc., 511 F.3d 1157, 1162 (Fed.Cir.2008) (“The [Palmaz] '762 patent discloses a coronary stent.”); Advanced Cardiovascular Sys. v. Medtronic Vascular, Inc., 485 F.Supp.2d 538, 550 (D.Del.2007) (Robinson, J.) (“Palmaz’ 417 discloses a stent.”); Medinol Ltd. v. Guidant Corp., 341 F.Supp.2d 301, 305 (S.D.N.Y.2004) (Scheindlin, J.) (“Palmaz patented a stent (Palmaz '417 Patent).”). 27. Figures 1A and IB of the Palmaz '762 (D.I. 70, Ex. E) and '417 patents (D.I. 70, Ex. G) “show the disclosed stent in its collapsed (Fig. 1A) and expanded (Fig. IB) forms,” Cordis, 511 F.3d at 1163, and this stent is for inclusion in a blood vessel. D.I. 70, Ex. G at Abstract (“intraluminal vascular grafts are expanded within a blood vessel by an angioplasty balloon ... to dilate and expand the lumen of a blood vessel”), see also id. at 5:26-35, 6:46-54. 28. “MarcTec admits that the Cypher drug-eluting stent would not meet ‘a surgical device for implementation in a body’ of claim 1 of the '753 patent and ‘an implant for implantation in a human body’ of claim 1 of the '290 patent based on the Court’s constructions and additional factual findings.” PL Resp. at page 33. 29. Cypher is a stent. As such, it cannot infringe either the '753 patent or the '290 patent under the Court’s claim construction. “Literal infringement requires that each and every limitation set forth in a claim appear in an accused product.” V-Formation, Inc. v. Benetton Group SpA, 401 F.3d 1307, 1312 (Fed.Cir.2005). B. The Cypher Stent is Fully Expandable From End-to-End 30. All of the asserted claims of the '753 patent require “an implant, at least a portion of which is expandable.” Similarly, ■ all the asserted claims of the '290 patent require that “at least a portion of the tubular member has a second cross sectional size ... larger than the first cross sectional size ... to thereby lock the tubular member against tissue in the human body.” 31. The Court has construed the phrase “an implant, at least a portion of which is expandable” from claim 1 of the '753 patent to mean that “a portion, but not all of the implant, is expandable.” D.I. 175 at 20. 32. Similarly, the Court has construed the phrase “a tubular member ... mechanically expandable ... from a contracted condition ... to an expanded condition in which at least a portion of the tubular member has a second cross sectional size ... larger than the first cross sectional size to thereby lock the tubular member against tissue in the human body” from claim 1 of the '290 patent to mean that “a portion, but not all, of the tubular member is expandable so that when expanded, its cross-sectional size is larger than its initial cross-sectional size. The expansion of only a portion of the tubular member enables it to be locked against tissue.” Id. 33. Because these constructions properly limit the language “at least a portion” to at least “a portion, but not all [of the device],” neither of the patents-in-suit can cover devices that expand in their entirety from end-to-end. Id. 34. MarcTec misreads the Court’s construction as requiring expansion in both the radial and longitudinal directions. D.I. 108 at 12-13; Pl. Resp. at pages 34-35. This is incorrect. As seen in claim 1 of the '290 patent, the relevant expansion is in the radial direction, such that “at least a portion of the tubular member has a second cross sectional size in a plane perpendicular to the longitudinal central ax is of the tubular member.” There is no requirement of longitudinal expansion in the claim language or in the Court’s construction of that language. 35. MarcTec’s medical expert concedes that Cypher is expandable along its entire length, from one end to the other. D.I. 125, Ex. 2 (Denardo Tr.) 174:24-175:7 (agreeing that “the diameter of the Cypher stent increases along its entire length once it’s balloon-expanded.”); see also PI. Resp. at page 35. Indeed, “MarcTec [itself] admits that the Cypher stent expands in its entirety in the radial direction.” PI. Resp. at page 8. 36. The Court’s construction requires expansion of a “portion, but not all” of the device and excludes devices where the device expands along its entire length. D.I. 175 at 20. As the Court previously found, a stent is a “fully expandable device.” Id. 37. Because the Cypher stent is expandable in its entirety from end-to-end, and indeed must be fully expanded to work, no reasonable juror could find infringement of either patent under the Court’s claim construction. V. The Cypher Coating Does Not Meet the Heat Bonding Claim Terms 38. All of the asserted claims require that the polymeric or heat bondable material must (1) be non-flowable and non-adherent at room temperature, (2) be bonded to the implant or tubular member, and (3) become flowable, tacky and adherent upon the application of heat. These terms, separately and together, require the use of heat to bond the polymer coating to the device. In particular, polymer coatings are excluded when, as in the Cypher stent, they adhere at room temperature. Rather, heat must be applied to cause the bond, and the heat must be such as to cause the otherwise non-adhering polymers to change state and become flow-able, tacky and adherent upon the application of heat. That is, heat must transform the material from one state to the opposite state (i.e., from being non-flowable and non-adherent at room temperature to being flowable and adherent upon the application of heat). 39. Under the Court’s construction of these terms, MarcTec cannot prove that the Cypher stent meets any of these limitations. Summary judgment of no literal infringement is therefore appropriate. See, e.g., K-2 Corp., 191 F.3d at 1366-69 (affirming grant of summary judgment of no infringement); General Mills, 103 F.3d at 983-85 (same). A. The Cypher Coating Adheres at Room Temperature 40. As construed by the Court, the phrase “non-flowable and non-adherent at room temperature,” means that the polymeric material (the '753 patent) and the heat bondable material (the '290 patent) cannot flow at room temperature and cannot adhere if placed on the device at room temperature. D.I. 175 at 27-28. Both requirements must be met for the claim to be infringed. V-Formation, 401 F.3d at 1312. 41. Undisputed evidence establishes that the polymers in Cypher’s drug-eluting coating adhere to the stent at room temperature. Room temperature polymer solutions are sprayed onto the stent at room temperature. D.I. 68, Ex. 1 (Maryanoff Decl.) ¶¶ 8, 10,12, 18. The stents are then air dried at room temperature. Id. at ¶¶ 13, 19. This air drying process allows the solvent to evaporate, leaving the polymers and drug adhered to the stent at room temperature. Id. at ¶¶ 9-10, 13, 20/ 42. MarcTec’s only expert on the ultimate issue of infringement, Dr. Batich, agreed that “the PEVA and PBMA polymers adhere to the Cypher stent at room temperature.” D.I. 125, Ex. 3 (Batich Tr.) 208:22-209:2. He agreed that “PEVA and PBMA polymers are applied to the stent at room temperature,” that “the solution that they’re applied in is at room temperature,” and that “you get some adhesion of PEVA and PBMA to the Cypher stent at room temperature.” Id. at 209:3-20; see also id. at 154:13-154:2, 156:17-22, 177:9-178:3. 43. With the evidence being undisputed on the relevant issue, MarcTec focuses on the use of a solvent during manufacture to excuse the fact that the polymers in the Cypher stent adhere at room temperature. D.I. 108 at 16-17, n. 13; D.I. 108, Ex.. 2 (Batich Rpt.) ¶ 100 (“When Defendants dissolve PEVA and PBMA in THF, that substance is no longer the polymeric material alone, but has become a solution of polymeric material and solvent.”); PI. Resp. at page 39 (same). MarcTec’s argument is incorrect. First, neither the-claims nor the Court’s construction requires the presence or absence of other materials (such as solvent). Moreover, Dr. Batich’s own admissions demonstrate that the polymers themselves adhere to the stent. 44. Dr. Batich readily admits that the polymers, not the solvent, adhere to the stent. In fact, the polymers adhere to the stent once the solvent evaporates, leaving the polymers behind. During the drying step, the solvent evaporates from the stent surface, leaving the polymers on the stent. It is after the THF evaporates that the polymers adhere to the stent. (D.I. 108, Ex. 2 (Batich Rpt.) ¶ 57). [A]s the solvent evaporates from the stent, the polymers become adhered to the stent. (Id. at ¶ 113). 45. In addition, Dr. Batich’s own testing shows that the polymers adhere at room temperature after the solvent, THF, evaporates. Q. And the PBMA coating adhered to the metal strips at room temperature when the THF evaporated, correct? A. Yes. D.I. 125, Ex. 3 (Batich Tr.) 124:7-10. Dr. Batich observed that this adherence occurred at room temperature after only thirty seconds of air drying. Id. at 124:1-10. This is precisely how solution casting works. Polymers are applied in solution and adhere to the substrate of interest at room temperate when the solvent evaporates. D.I. 68, Ex. 1 (Maryanoff Deck) ¶¶ 8-10; D.I. 114, Ex. 9 (Storey R. Rpt.) at 8. 46. Finally, MarcTec tries to change the frame of reference by asserting that the raw polymers do not “stick[] to the glass, to spatulas, or to anyone’s hand” and that “the final product does not adhere to external sources such as instruments or hands at room temperature.” D.I. 108 at 6, 8 and 17; see also PI. Resp. at pages 39-41, 63. This is irrelevant. Under the Court’s construction of the disputed claims, the issue is not whether the polymers adhere at room temperature to glass or spatulas or skin; rather, the issue is whether they adhere to the accused device. D.I. 175 at 27-28. The evidence on that issue is undisputed. D.I. 125, Ex. 3 (Batich Tr.) 209:3-20, 95:8-20, 177:9-178:3, 180:7-17. 47. Because the polymers adhere to the accused device at room temperature, the asserted claims of the '753 and '290 patents do not cover the Cypher stent. B. The Cypher Coating is Not Bonded By Heat 48. All of the asserted claims require a material to be bonded to the device. The claims of the '753 patent require “a polymeric material bonded to the implant” and the claims of the '290 patent require “a first component bonded to at least a portion of the tubular member.” 49. The Court has construed these claim terms as requiring that the material is bonded to the implant or tubular member “by the application of heat.” D.I. 175 at 26. This construction requires that the heat applied to the polymers must cause the bond, not simply facilitate the bonding process. 50. Testing by Cordis’s expert, Dr. Storey, showed that the Cypher drug-eluting coating would have to be exposed to temperatures above 62°C (144°F) to observe flow, tackiness or adherence due to heat. D.I. 68, Ex. 2 (Storey Deck) ¶ 7. MarcTec’s expert Dr. Batich showed that the polymers used in the Cypher stent would need to be heated to temperatures above 70°C (158°F) in order to become flowable, tacky or adherent by the application of heat so as to bond to the device. D.I. 108, Ex. 2 (Batich Rpt.) ¶¶ 72-73, 75-76, 103-105, Ex. H; D.I. 125, Ex. 3 (Batich Tr.) 107:6-20. 51. It is undisputed that the polymers in Cypher’s coating are never exposed to such temperatures. D.I. 125, Ex. 3 (Batich Tr.) 152:2-14 (agreeing that “the highest temperature during the Cordis manufacturing process that either the Cypher stent sold in the U.S. or the OUS markets are subjected to is 35 degrees Celsius” and that “the highest temperature that the Cypher stents designated for the Japanese market are exposed to is 45, plus or minus 5 degrees Celsius.”). The polymers in the Cypher coating are applied to the device by spraying at room temperature and bond to the device at room temperature. As Dr. Batich admits, the “entire coating process occurs at room temperature.” D.I. 125, Ex. 3 (Batich Tr.) 156:17-22; see also id. at 177:9-178:3, 209:3-20. Moreover, because the polymers in Cypher’s drug-eluting coating are not exposed to temperatures above 62°C or 70°C, it is not possible for the polymers to be bonded to the Cypher stent by the application of heat. D.I. 114, Ex. 9 (Storey R. Rpt.) at 33; D.I. 125, Ex. 3 (Batich Tr.) 107:6-20. 52. MarcTec mischaracterizes the claim construction adopted by the Court as merely requiring the use of heat to “facilitate the bonding of the polymeric material to the stent.” D.I. 108, Ex. 2 (Batich Rpt.) ¶49 (“[defendants’ proposed construction apparently requires the application of heat to facilitate the bonding of the polymeric material to the stent.”); D.I. 125 Ex. 3 (Batich Tr.) 170:7-12 (same). This is incorrect. Consistent with what Dr. Bonutti actually invented, the Court’s claim construction requires that heat applied to the polymers must cause the bond. D.I. ,175 at 25-26. As this Court has held, Dr. Bonutti’s amendments “made clear that Dr. Bonutti’s invention required the application of heat to a heat bondable material to cause that material to transform from one state (non-flowable and non-adherent) to a different state (flowable, tacky and adherent).” Id. at 11; see also id. at 23 (Dr. Bonutti’s argument “limits his claims so as to exclude devices where a material is bonded to the device other than by the application of heat”); id. at 28 (“It takes heat to bond in the Bonutti invention and that heat must be sufficient to cause the material to be bonded to become flowable, tacky and adherent.”); see also D.I. 70, Ex. A (’753 patent) at 1:66-2:18. 53. Under its incorrect “facilitation” standard, MarcTec relies on any step that involves heat regardless of what, if anything, is being heated and whether it causes the polymers to bond to the device. D.I. 108 at 14-16; Pl. Resp. at pages 16-17; D.I. 108, Ex. 2 (Batich Rpt.) ¶¶ 49-65. Such evidence is not premised on the correct judicial claim construction and has no relevance to Cordis’s motion. PIN/NIP, 304 F.3d at 1246 (arguments addressing an incorrect construction have no relevance). As MarcTec admits “ ‘[cjomparisons based on an incorrect claim construction have no relevance and cannot aid the fact finder.’ ” D.I. 117 at 4. 54.The undisputed facts establish that Cypher does not infringe under the Court’s claim construction. Cypher’s polymers are applied to the device at room temperature and bond to the device at room temperature. Plaintiffs expert Dr. Batich admits that the coating process occurs at room temperature and that heat is not applied to the polymers. D.I. 125, Ex. 3 (Batich Tr.) 156:17-158:6, 177:9-178:3, 209:3-20. Q: [A]re you aware of any evidence, whether tests or literature showing an increase in temperature above room temperature throughout the entire period from the application of the base coat solution through final weighing of a coated Cypher stent? • A: I am not aware of any experimental evidence showing any increase in temperature over the — that part of the coating process. (Id. at 180:7-17 (objection omitted)). 55. MarcTec’s expert, Dr. Batich, relies on an untested prediction by another MarcTec expert, Dr. Sojka, that spraying droplets at unrealistically high speeds will increase their temperature by 0.45-18°C depending on the size of the droplet and that spraying the smallest hypothetical droplet at “maximum velocity” would increase its temperature (from room temperature, 17-24°C, to 35-42°C) for an infinitesimally short period of time (five millionths of a second). D.I. 108 at 15; Pl. Resp. at pages 10, 17, 63-64; D.I. 115, Ex. 4 Expert Report of Paul E. Sojka, Ph.D. (“Sojka Rpt.”) at 5-6; D.I. 125, Ex. 4 (Sojka Tr.) 136:4-8, 163:17-23; 185:15-186:4. 56. MarcTec’s experts did not test Dr. Sojka’s theory and could not identify any tests or publications supporting his untested predictions. D.I. 125, Ex. 4 (Sojka Tr.) 72:15-74:9, 99:23-100:21; D.I. 125, Ex. 3 (Batich Tr.) 163:16-164:1, 165:24-166:4. In his deposition, Dr. Sojka admitted that the five millionths of a second (0.000005) period that his prediction is limited to is a period so infinitesimally brief his predicted temperature increase has not been and cannot be experimentally tested or verified. D.I. 125, Ex. 4 (Sojka Tr.) 58:18-59:3, 163:6-23. 57. Dr. Sojka admitted that he is not aware of any instrumentation that could detect an increase in temperature in the fleeting 0.000005-second interval that is the subject of his opinion. Id. at 161:11— 162:1 (“I know of no equipment that would be available to detect the temperature of a drop impacting a surface in that 5-micro-second interval.”); see also id. at 35:9-36:4 (“[t]emperature-measuring equipment typically cannot respond to anything like that time interval”); id. at 162:12-163:5 (“we don’t have techniques that will measure the temperature of the — of the substance that contained in the drop for that — for the 5 microseconds that each individual drop impacts the surface, not that I know of’); id. at 163:6-16 (“I don’t know of a technique that could be — ’that could be used to measure the temperature increase of that substance, the substance that is in the drop, in a roughly 5-microsecond time period.”). 58. Dr. Sojka had no opinions on any increase in temperature that is capable of being measured or tested. Thus, he had no opinions on whether there was any increase in temperature before or after the 0.000005 second interval, id. at 185:15-186:4, and had no opinions on whether spraying would result in any increase in the surface temperature of the Cypher stent itself. Id. at 36:24-37:10, 56:10-13. 59. Dr. Sojka’s theories are also contrary to everyday experience. If spraying a fluid on a surface automatically increased its temperature, a cold shower would feel hot, not cold. As MarcTec’s experts admit, this is not the case. D.I. 125, Ex. 3 (Batich Tr.) 165:6-17; D.I. 125, Ex. 4 (Sojka Tr.) 168:16-169:3. 60. Dr. Sojka also based his untested and untestable predictions on extreme conditions that are not related to the Cypher manufacturing process. Dr. Sojka admitted that he did not know anything about the Cordis spray process, including the actual droplet velocities. D.I. 125, Ex. 4 (Sojka Tr.) 85:14-16, 106:5-110:20. Although he assumed that the droplets used during spraying would travel at speeds up to % the speed of sound (248 meters per second or 575 m.p.h.), Dr. Sojka was not aware of a spraying process for any medical device that causes droplets to move at anything approaching this speed. Id. at 79:18-80:7, 94:14-18. 61. Dr. Sojka has published papers in which he has described the use of available equipment to measure the velocity of droplets in a spray. D.I. 114, Ex. 3 (Sojka Tr.) 39:6-23. In these studies what he found is that the droplets move at speeds of only 1.5-to-3.5 meters per second — a small fraction of the 248 meters per second that he assumed here. Id. at 175:2-24. 62. Dr. Sojka’s theory that spraying droplets at an unrealistic speed, approaching the speed of sound (and unrelated to anything that happens in the Cypher coating process) would increase the temperature of the droplets — in ways that cannot be measured — for 5 millionths of a second (0.000005 seconds) is an untested and untestable theory that is neither reliable not relevant to the issues at hand. Dr. Sojka’s testimony, accordingly, is inadmissible under Daubert v. Merrell Dow Pharms. Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) and Federal Rule of Evidence (“FRE”) 702. 63. Dr. Sojka did not know what heat bonding was, D.I. 125, Ex. 4 (Sojka Tr.) 70:1-9, and had no opinions concerning adhering polymers to a surface. Id. at 102:4-7. Dr. Batich relied upon Dr. Sojka’s untested prediction to conclude that spraying somehow “facilitates” the bonding of one polymer, PBMA, to Cypher. D.I. 108, Ex. 2 (Batich Rpt.) ¶51, 56. MarcTec offered no evidence to support Dr. Batich’s speculation that an increase in the temperature of polymer droplets that lasts only five millionths of a second — even if real — would allow PBMA. to bond to the device. 64. Dr. Batich’s opinions concerning spraying also are predicated on an assumption that PBMA will bond to the Cypher stent at 35°C. D.I. 108, Ex. 2 (Batich Rpt.) ¶ 56. Dr. Batich claims to have observed some adhesion at 35°C when using a 2.3 kg. weight that the PBMA in Cypher is never subjected to. Id.; D.I. 125, Ex. 3 (Batich Tr.) 182:2-184:6. In its manufacturing process, Cordis does not use a 2.3 kg. weight — or any other weight — to press the polymers onto the device. D.I. 125, Ex. 3 (Batich Tr.) 183:1-4, 143:7-10, 147:23-148:6. Indeed, Dr. Batich admitted that placing a 2.3 kg. weight on top of a Cypher stent “would destroy the product.” Id. at 143:21-144:1. As discussed further below, Dr. Batich’s experiment was performed under extreme experimental conditions unrelated to the actual manufacture of the Cypher stent, and testimony concerning this test is inadmissible under Daubert and FRE 702. See also In re: Silicone Gel Breast Implants Products Liab. Litig., 318 F.Supp.2d 879, 902-03 (C.D.Cal.2004) (Matz, J.) (excluding testing by Dr. Batich in another case because he employed “extreme” conditions). 65. Cordis’s expert Dr. Atwood conducted a simple experiment to test MarcTec’s hypothesis that spraying THF increases temperature. He sprayed THF on a thermistor (a device used to detect temperature change). The results showed that spraying cooled the thermistor over a period of seconds, rather than heating it. D.I. 114, Ex. 8, Expert Report of Professor Jerry L. Atwood, Ph.D. (“Atwood Rpt.”) ¶¶ 61-63; D.I. 125, Ex. 4 (Sojka Tr.) 152:9-153:23. His experiment provides uncontradicted empirical evidence that spraying does not cause an increase in temperature above room temperature. Dr. Batich “believe[s] [Dr. Atwood’s] results” and is “not aware of any experimental tests conducted by or on behalf of MarcTec showing that spraying THF will cause an increase in temperature.” D.I. 125, Ex. 3 (Batich Tr.) 162:12-163:20. Dr. Sojka also admitted that he did not “have any reason to question the validity of [Dr. Atwood’s] measurements.” D.I. 125, Ex. 4 (Sojka Tr.) 154:16-17. 66. Although MarcTec’s experts do not dispute Dr. Atwood’s findings (i.e., that spraying of THF results in a decrease in temperature over a period of seconds), MarcTec argues that Dr. Atwood’s findings do not refute Dr. Sojka’s untested prediction. PI. Resp. at page 45. This is because Dr. Sojka’s opinion is limited to a supposed temperature change that lasts only .000005 seconds — a period so brief that no instrument can measure it, whereas Dr. Atwood investigated a measurable effect — the effect of spraying THF on the “order of seconds.” D.I. 125, Ex. 4 (Sojka Tr.) 152:24-153:23. Dr. Sojka’s opinion is untestable and contrary to anything which can be measured and tested, such as Dr. Atwood’s demonstration that the spraying of THF does not increase temperature. Dr. Sojka’s spraying theory is inadmissible for this and the other reasons discussed above. 67. MarcTec also attempts to equate evaporation of solvent with heating. D.I. 108 at 15; PI. Resp. at pages 15, 17. If evaporation ■ of THF caused heating, then Dr. Atwood’s study would have shown an increase in temperature. But as discussed above, it showed the exact opposite. Again, this is not surprising. Everyday experience tells us that natural evaporative cooling, perspiration, cools the human body rather than heats it. D.I. 125, Ex. 3 (Batich Tr.) 166:5-10; Ex. 4, Sojka Tr. 129:3-10. Indeed, Dr. Batich admitted at his deposition that evaporation will not increase the temperature of the polymers. D.I. 125 Ex. 3 (Batich Tr.) 167:11-14. Q. Does the evaporation of THF increase the temperature of PEVA and PBMA? A. I don’t think the evaporation process would increase their temperature. 68. In short, MarcTec cannot show any use of heat when the polymers are being applied to the device and bond to it. Instead, it argues that heat is used earlier or later in Cypher’s manufacturing process. D.I. 108 at 14-16; Pl. Resp. at pages 16-18, 63-65. Neither has any bearing on whether the polymers are bonded to the device by the application of heat. Dr. Batich’s testimony that such steps “facilitate” bonding (D.I. 108, Ex. 2 (Batich Rpt.) ¶¶ 49-65) does not address the requirements of the Court’s claim construction and is irrelevant to the question of infringement. It is also inadmissible under Daubert. 69. Manufacturing steps that occur before the Cypher coating is applied cannot bond the polymers to the stent. For example, MarcTec points out that heat is used to cure silane and crack the precursor to Parylene C (paracyclophane dimer), which is used to coat the stent before the PEVA and PBMA polymers are applied, and to anneal Parylene C for the Japanese product. D.I. 108 at 14-15; Pl. Resp. at pages 16-17, 63. But this heat is not applied to PEVA or PBMA, the polymers in Cypher’s drug-eluting coating. It is undisputed that those polymers are applied at room temperature to a room-temperature Parylene-C coated stent. D.I. 125, Ex. 3 (Batich Tr.) 154:10-155:2 (agreeing that the room temperature “solution is applied by spraying [] a room temperature, parylene C-coated stent” and that there is no “reason to believe that [a] stent sitting in the room temperature environment is at anything other than room temperature”) id. at 209:3-9 (agreeing that “PEVA and PBMA polymers are applied to the stent at room temperature” and that “the solution that they’re applied in is at room temperature.”). 70. MarcTec’s reliance on solution preparation (D.I. 108 at 6-7; Pl. Resp. at pages 10-11, 16-17, 63) is similarly misplaced. Cordis uses temperatures of 32°C or below to dissolve PEVA and PBMA in solvent, but this is irrelevant to the question of infringement. Once the polymers are dissolved, the solution is lowered to room temperature and stored for up to 10 days at room temperature. D.I. 125, Ex. 3 (Batich Tr.) 154:3-12. Only then is the polymer solution applied and the polymers bonded at room temperature to a room temperature stent. Id. at 154:3-155:2, 209:3-20. 71. In addition, temperatures of 32°C and below are nowhere near 70°C and above, the temperature that MarcTec’s expert, Dr. Batich, agrees is necessary for PEVA or PBMA polymers to become flow-able, tacky and adherent due to heat, and, thus, to bond. Id. at 107:6-20. Dr. Batich also agreed that the polymers will adhere to the stent whether the solutions are warmed or not; warming the solution only impacts how quickly the polymers dissolve during solution preparation. Id. at 117:8-118:10. 72. Finally, Dr. Batich admitted that, just as for the silane and Parylene C steps, solution preparation occurs prior to the application of the PEVA and PBMA polymers to the stent and cannot bond the polymers to the stent (id. at 153:18-154:2): Q. And all of those steps — silane, parylene C deposition and solution making — precede the application of PEVA and PBMA polymers to the stent, correct? A. Yes. Q. And you’ll agree with me that PEVA and PBMA cannot be bonded to the stent before they’re even applied to the stent, correct? A. Correct. In arguing to the contrary, MarcTec simply ignores the testimony of its own expert. PL Resp. at page 46. It never explains how steps that occur long before the polymers are applied to the stent at room temperature can bond the polymers to the s