Full opinion text
FINDINGS OF FACT, CONCLUSIONS OF LAW AND ORDER ALSOP, Senior District Judge. TABLE OF CONTENTS Findings of Fact Page I. Background Facts 823 A. Nature of the Action and the Parties 823 B. Background of the Invention 824 C. The ’129 Patent 826 D. Reexamination of the ’129 Patent 827 II. Infringement 828 A. Claim Construction of the T29 Patent 828 (i) The “Integral” Limitation 828 (ii) The “Relatively Short”/“Substantially Distal” Limitations 830 (iii) The “First Tube” and “Sufficient Stiffness” Limitations 830 (iv) The “Stabilizing Wire” Limitation 831 (v) Scope of Coverage of the ’129 Patent Claims 831 B. The Structure of the EXPRESS and the RALLY 831 (i) The EXPRESS 831 (ii) The RALLY 831 C. Literal Infringement 832 (i) The EXPRESS 832 (ii) The RALLY 833 D. The Doctrine of Equivalents 833 (i) The “Integral” Limitation 833 (ii) The “Relatively Short”/“Substantially Distal” Limitations 833 (iii) The “First Tube” Limitation 834 (iv) The “Sufficient Stiffness” Limitation 834 (v) The “Integral Stabilizing Means” Limitation 834 III. Validity 834 A. One of Ordinary Skill in the Art 834 B. Scope and Content of Prior Art/Differences Between the Prior Art and the Claims at issue 834 (i) Scope of the Relevant Prior Art 834 (ii) Content of the Alleged Prior Art/Differences Between the Prior Art and the Claims at Issue 835 (a) Borisenko 835 (b) Nordenstrom 835 (c) Morton 836 (d) Esophagal Devices 837 (e) Hartzler 837 (f) Perfusion Catheters 837 (g) Kaltenbach 837 (h) Leary 838 C. The Claimed Catheter would not have been Obvious to One of Ordinary Skill in the Art 838 D. Secondary Considerations 838 (i) Background — Development of Schneider’s Catheters 838 (ii) Commercial Success of Schneider’s Catheters 839 Page (iii) Commercial Success of Infringing Catheters 889 (iv) Other Secondary Considerations 839 E. Inequitable Conduct 840 IV. Willfulness 841 V. Damages 844 A. Background 844 B. Lost Profits 845 (i) Demand for the Patented Product 845 (ii) Absence of Non-Infringing Alternatives 845 (iii) Ability to Meet Demand 846 (iv) The Amount of Loss 846 C. Reasonable Royalty 847 (i)Georgia-Pacific Factors 847 D. Prejudgment Interest 850 VI. Attorney Fees and Costs 850 VII. Permanent Injunction 850 Conclusions of Law I. Infringement 851 A. Claim Construction 851 B. Infringement by the SciMed EXPRESS™ and RALLY™ catheters 852 (i) Literal Infringement 852 (ii) Doctrine of Equivalents 852 II.Validity ' 852 A. Obviousness 853 B. Secondary Considerations 854 C. Inequitable Conduct 855 III. Willfulness 856 IV. Damages 857 A. Background 857 B. Lost Profits 858 (i) Demand for the Patented Product • .858 (ii) Absence of Non-Infringing Alternatives 858 (iii) Ability to Meet Demand 859 (iv) The Amount of Loss 859 C. Reasonable Royalty 859 D. Prejudgment Interest 860 V. Attorney Fees and Costs 860 VI. Permanent Injunction 861 Damage Tables 864 Order 869 Form of Permanent Injunction 869 Based on the evidence presented at trial, the oral and written arguments of counsel, and all the files, records, and proceedings herein, the Court makes the following Findings of Fact and Conclusions of Law: FINDINGS OF FACT I. Background Facts a. Nature of the Action and the Parties L This ig a patent infringement action with federal jurisdiction based upon 28 U.S.C. § 1338(a) (1988 & Supp.1993). Venue is proper pursuant to 28 U.S.C. § 1400(b) (1988 & Supp.1993). 2. Plaintiff Schneider (USA) Inc. is a corporation organized and existing under the laws of the State of Minnesota and having its principal place of business in Plymouth, Minnesota. Plaintiff Schneider (Europe) AG is a corporation organized and existing under the laws of Switzerland and having its principal place of business in Bulach, Switzerland. 3. Defendant SciMed Life Systems, Inc. (“SciMed”) is a corporation organized and existing under the laws of the State of Minnesota and having its principal place of business in Maple Grove, Minnesota. 4. U.S. Patent No. 4,762,129 originally issued on August 9, 1988 (“’129 patent”). Subsequently, the ’129 patent was subject to a reexamination proceeding in the Patent and Trademark Office (“PTO”) pursuant to 35 U.S.C. § 304 (1981 & Supp.1993). At the conclusion of the proceeding, Reexamination Certificate BI 4,762,129 (“ ’129 reexamination certificate” or “reexamination certificate”) was issued on July 2, 1991. 5. Plaintiff Schneider (Europe) AG is the exclusive licensee of the ’129 patent and the ’129 reexamination certificate under a license agreement with the patentee, Dr. Tassilo Bonzel. Plaintiff Schneider (USA) Inc. is a licensee of Schneider (Europe) AG under the ’129 patent and the ’129 reexamination certificate. See Schneider (Europe) AG and Schneider (USA) Inc. v. SciMed Life Systems, Inc., No. 3-91 CIV 241, slip op. at 11, 1993 WL 463204, at *3-4 (D.Minn. May 14, 1993) (Alsop, J.) (setting forth relationship and rights between Schneider (Europe) and Schneider (USA) under the license agreement). 6. Schneider filed suit against SciMed on April 23, 1991, alleging that, by making, using, and selling its EXPRESS™ dilatation catheter, SciMed wilfully infringed the ’129 patent. Schneider seeks damages, increased damages, and attorney fees. Schneider also seeks a permanent injunction enjoining SciMed from manufacturing and selling the EXPRESS™. 7. Schneider amended its complaint on October 16, 1992 to specifically allege that SciMed’s actions in connection with its new dilatation catheter, the RALLY™, infringe the ’129 patent. 8. On June 11,1993, Schneider moved for a preliminary injunction to prevent SciMed from making, using, or selling the RALLY ™ in the United States. That motion was subsequently withdrawn and then renewed at trial. Schneider now seeks a permanent injunction enjoining SciMed from manufacturing and selling the RALLY™. B. Background of the Invention 9. The ’129 patent relates to a medical device, referred to as a “balloon dilatation catheter,” which is used for treating coronary artery disease. A balloon dilatation catheter is a long, thin, plastic tube with an expandable balloon near its tip. The end of the catheter where the balloon is located is referred to as the “distal” end, while the opposite end is called the “proximal” end. During use, the proximal end of the catheter is adjacent the physician and the distal end is inside the patient’s body near the heart. 10. The coronary arteries supply blood to the heart, carrying nutrients and oxygen to heart muscle tissue. Coronary artery disease results from fatty plaque deposits on the interior surfaces of the artery. These deposits (or “lesions”) cause a reduction in the area available for blood to flow through the artery. The areas where these deposits form are referred to as “stenoses.” 11. A procedure, known as “angioplasty,” is used to open up the lesions with a guiding catheter, a guide wire, and a balloon dilatation catheter. A Percutaneous Transluminal Coronary Angioplasty (“PTCA”) procedure is a special angioplasty procedure that is a less invasive alternative to coronary artery bypass surgery. PTCA procedures are performed by specialists known as “interventional cardiologists.” Interventional cardiology is a medical specialty dealing with interventional procedures in the heart. This specialty is distinct from radiology or vascular surgery. 12. PTCA was first performed in a human by Dr. Andreas Gruntzig in 1977. Dr. Gruntzig was the first person to discover that a balloon dilatation catheter could be used for angioplasty in the coronary arteries if the balloon is constructed from inelastic material. 13. A PTCA procedure is begun by inserting a guiding catheter into the femoral artery in the patient’s groin area. The guiding catheter is a long, hollow, plastic tube that serves as a tunnel from the patient’s groin to the coronary arteries. The guiding catheter is passed through the vasculature from the groin area up through the aorta to the entrance of the coronary arteries. The entrance to the coronary arteries is called the “ostium.” 14. Dr. Gruntzig developed the first balloon dilatation catheter, which became known as a “fixed-wire” catheter (“FWC”). When a FWC is used in a PTCA procedure, the catheter is inserted directly through the guiding catheter up to the entrance to the coronary arteries. The dilatation catheter is then pushed beyond the end of the guiding catheter and into the coronary arteries. During this time, an X-ray device called a “fiuoroscope” is used by the cardiologist to monitor the position of the dilatation catheter. The dilatation catheter is then positioned so that the deflated balloon is located at the stenosis. At that point, liquid is injected into the catheter and the balloon is inflated. Inflation of the balloon causes a compression force on the stenosis that cracks the stenosis and stretches the artery. Normal blood flow through the artery is thereby restored. 15. The next major advance in PTCA occurred in 1978 with the development of what became known as the “over-the-wire” catheter (“OTW”). This advance has been generally attributed to Dr. John Simpson and Dr. Edward Robert. In an OTW catheter, the dilatation catheter contains two internal tubes that run the length of the catheter. One tube, the “inflation lumen” (or “inflation tube”), is connected to the interior of the balloon and is used to inflate the balloon. The second tube, known as the “guide wire lumen” (or “guide wire tube”), receives an independently moveable guide wire. 16. In November 1984, there were three predominant manufacturers of OTW catheters. Advanced Cardiovascular Systems (“ACS”) made the catheter originally designed by Drs. Simpson and Robert. In the ACS OTW catheter, the guide wire tube is located inside the inflation tube in a “coaxial” construction. The other two major manufacturers of OTW catheters in 1984 were Schneider Medintag (a predecessor company to Plaintiff Schneider (Europe)) and the USCI division of C.R. Bard (“Bard”). Both Schneider Medintag and Bard sold OTW catheters in which the guide wire tube was laterally displaced from the inflation tube. This design is referred to as a “dual-lumen” construction. 17. The standard-length guide wire used with OTW catheters in November 1984 was about 175 centimeters. The typical length of OTW catheters available in November 1984 was about 135 centimeters. 18. When a cardiologist uses an OTW catheter, the guide wire is placed into the guide wire lumen of the OTW catheter prior to insertion into the guiding catheter. The OTW catheter and guide wire are inserted together and advanced to the tip of the guiding catheter. Next, the guide wire is advanced independently and located at the stenosis. This part of the procedure is difficult and time-consuming. As a result, the majority of cardiologists in November 1984 believed that, once proper guide wire placement was achieved, it was highly desirable to maintain the guide wire in place, across the stenosis. After the guide wire is located at the stenosis, the OTW catheter is advanced along the guide wire until the balloon is located at the stenosis. If the balloon is the correct outside diameter to fit through the stenosis, the balloon is expanded by injecting inflation fluid through the inflation lumen. The stenosis is thereby expanded and normal blood flow is restored through the artery. 19. During a PTCA procedure, it is sometimes necessary to exchange the dilatation catheter for a second catheter with a different diameter balloon. For example, exchange is necessary if the balloon on the original catheter is either too large to fit through the stenosis in its uninflated state or its inflated diameter is too small to properly expand the stenosis. 20. Due to the difficult and time-consuming procedure of locating the guide wire at the stenosis, the typical interventional cardiologist in 1984 preferred to leave the guide wire in place during a catheter exchange. In order to do so, the operator needed to hold the end of the guide wire that extended from the patient throughout the exchange process. Because of the length of the standard guide wire compared to the OTW catheter, a cardiologist who tried to withdraw the OTW catheter would lose the end of the standard-length guide wire. 21. Prior to November 1984, the typical interventional cardiologist faced with the problem of exchanging an OTW catheter had three basic options. First, the dilatation catheter and guide wire could both be withdrawn together. Then, the-entire procedure described above could be repeated with the second OTW catheter and guide wire. The second option was for the cardiologist to use an exchange wire. The standard wire is removed before the exchange wire is used. The typical exchange wire is 300 centimeters long and is inserted into the OTW catheter that needs to be exchanged. The old OTW catheter is withdrawn and a new OTW catheter is inserted over the exchange wire. The proximal end of the exchange wire typically extends to the ankles of the patient. Therefore, a second operator is needed to hold the end of the wire while the dilatation catheters are exchanged. In addition to being awkward and time-consuming, this option is problematic because the end of the wire sometimes falls off the table and becomes contaminated. Another problem is that the exchange wire can injure the operators if it “springs up” during the procedure. The third option involves starting the procedure with a 300 centimeter wire, as described by Kaltenbach, rather than with a standard-length wire. The benefit of this option is that, should an exchange become necessary, a long wire is immediately available. The third option, however, suffers from the same disadvantages as the second option. Beginning in 1986, a fourth option was practiced, which involved using an “extension” or “docking” wire. These are wires which are attached to the proximal end of the standard-length guide wire when an exchange becomes necessary. The total length of the extension and standard-length guide wire is about 300 centimeters. Balloon catheter exchange over the extension wire created difficulties. The second, third, and fourth options discussed above involve modifying the guide wire. They do not involve modifying the configuration of the OTW dilatation catheters, which had full-length inflation and guide wire lumens. 22. The conventional, prevalent view among the majority of cardiologists in November 1984 was that it was necessary for an OTW catheter to have a full-length guide wire lumen. The full-length lumen provided advantages which were considered important. First, the full-length guide wire lumen was used to measure blood pressure through the distal end of the catheter after a PTCA procedure to determine if the procedure was successful. Second, the full-length guide wire lumen was used to inject dye into the coronary artery through the distal end of the catheter to view the stenosis on an X-ray. Third, the cardiologist preferred to have the ability to leave the dilatation catheter in place while withdrawing the guide wire, reshaping its tip, and reinserting the guide wire. None of these capabilities were available on a catheter without a full-length guide wire lumen. C. The ’129 Patent 23. The 129 patent is entitled to a priority date of November 23, 1984. On that date, Dr. Tassilo Bonzel filed his priority patent application in the Federal Republic of Germany. Subsequently, on November 15, 1985, a Patent Cooperation Treaty application was filed designating the United States. Under 35 U.S.C. § 363 (1981 & Supp.1993), this date is deemed to be the filing date of the 129 patent in the United States. The United States application was perfected on July 14, 1986 and assigned application number 893,-558. The ’129 patent issued on August 9, 1988. 24. The claims of the ’129 patent cover a dilatation catheter and the method of using that catheter. The dilatation catheter claimed in the ’129 patent represents a major improvement over the conventional OTW catheters that were available in November 1984. It allows for rapid exchange of the catheter by a single cardiologist using a standard-length guide wire, while the guide wire remains in place with its distal end across the stenosis. 25. The ’129 patented device is within a distinct market segment. This segment is called interchangeably, “SOE”, “rapid-exchange,” “monorail,” and “monorail-type.” “Monorail” is the trade name of the original Schneider rapid-exchange catheter, but it is also used generically to describe all catheters within the rapid-exchange segment of the PTCA market. 26. Dr. Bonzel realized that, by making the guide wire tube relatively short compared to the inflation tube, a single cardiologist could easily and rapidly exchange one dilatation catheter for another over a stationary standard-length guide wire. Since the guide wire tube is relatively short compared to the inflation tube, the guide wire is not enclosed within the entire length of the dilatation catheter. As a result, the cardiologist can hold the end of the guide wire during the entire exchange procedure without using an exchange wire. 27. Other important advantages of the invention listed in Dr. Bonzel’s patent specification include the ability to achieve bare wire or “wire first” access to the stenosis with a standard-length guide wire (the physician can place the standard-length wire across the stenosis before loading the dilatation catheter onto the wire) and reduced friction between the guide wire and dilatation catheter. The Bonzel invention is also advantageous in that it reduces the amount of exposure to radiation during a PTCA procedure. The primary feature, however, of the ’129 patented device, is its rapid-exchange capability. D. Reexamination of the ’129 Patent 28. On November 25, 1988, Bard filed a Request for Reexamination of the ’129 patent with the PTO. Bard filed two additional Requests for Reexamination of the ’129 patent on October 25, 1989 and on May 1, 1990. In addition, Advanced Cardiovascular Systems, Inc. (“ACS”) filed a Request for Reexamination of the ’129 patent on March 16, 1990. All four Requests for Reexamination were granted and merged into a single proceeding before the PTO. SciMed did not file a Request. 29. Each Request for Reexamination is considered by a primary examiner in the PTO. The examiner in the 129 patent reexamination proceedings was Michael H. Thaler. 30. During the reexamination proceedings, the examiner considered an extensive list of prior art references, including, but not limited to, the following: the Leary reference; the Samson 181 patent; the British Journal of Surgery article (“Erlem”); the Dotter reference; the Kaltenbach article; the Seldinger Technique article; the Nordenstrom 1962,1965, and 1966 articles; the Borisenko patented device; various Fogarty references; and the Cardiospasm article by Moersch, which refers to an esophagus dilator. The examiner determined that the claims in the 129 reexamination certificate were patentable after considering these and many other references. See Reexamination Certificate B1 4,762,129 (Plaintiffs’ Trial Exhibit 1). Perfusion prior art, such as Erbel, was not before the examiner, but was presented by SciMed at trial. 31. On March 4, 1991, the PTO issued an Office Action in which it indicated that certain pending claims were allowed and certain claims were rejected. The allowed claims ultimately became the claims of the 129 reexamination certificate. On April 19, 1991, the PTO issued a Notice of Intent to Issue a Reexamination Certificate. 32. On July 2, 1991, the PTO issued Reexamination Certificate B1 4,762,129. As of that date, the claims in the reexamination certificate replaced those in the original 129 patent. Thus, Schneider’s claim for infringement against SciMed is based on the claims in the reexamination certificate. II. Infringement A. Claim Construction of the T29 Patent 33. Schneider contends that the SciMed EXPRESS™ and the SciMed RALLY™ catheters infringe apparatus and method claims 1, 3-11, 13, 14 and 16-27. 34. Reexamination Claim 5 includes all of the elements in dispute in this case. The disputed elements are italicized and in bold: (a) providing an elongated guide wire having distal and proximal ends and a dilatation catheter comprising an expandable balloon having distal and proximal ends, a first, relatively long, elongated kollou) tube having distal and proximal ends and opening adjacent its distal end into interior of the expandable balloon, the first tube being sealingly connected to the proximal end of the balloon, and a second, relatively short, elongated hollow tube integral with said first tube, having distal and proximal ends, and adapted to receive said guide wire in a sliding fit, the second tube traversing the interior of the expandable balloon from the distal end to the proximal end of the balloon and being sealingly connected to the distal end of the balloon, and the second tube terminating at its proximal end substantially distally of the proximal end of the first tube in an aperture open to the exterior of the catheter, said first tube having sufficient stiffness that the second tube and expandable balloon can readily be advanced or withdrawn together in use along the guide wire by exerting a pushing or pulling force upon the first tube____ Reexamination Certificate B1 4,762,129, Claim 5, Col. 2, Lines 40-65. 35. SciMed also takes issue with the “stabilizing wire” limitation recited in Claims 3, 7, and 10 with respect to the RALLY™. 36. Thus, the claim construction issues identified by the parties regarding infringement relate to: 1) the meaning of “integral” in relation to the first and second tubes (inflation and guide wire tubes). SciMed claims that “integral” should be narrowly defined to mean a dual-lumen catheter where the tubes are laterally displaced from each other and made of one-piece; 2) the limits on the length of the guide wire tube due to the claim terms “substantially distally” and “relatively short.” SciMed claims that the length of the guide wire tube can be only about as long as the balloon; 3) whether the EXPRESS ™ and the RALLY ™ catheters possess a “first tube” (inflation tube) that both i) opens adjacent its distal end into the interior of the balloon and ii) alone possesses “sufficient stiffness” to advance the distal end of the catheter (the balloon and the guide wire tube); and 4) whether the RALLY ™ catheter possesses the “stabilizing means” of reexamination claims 3, 7, and 10. (i) The “Integral” Limitation 37. SciMed’s assertion that the term “integral” is limited to a one-piece, dual-lumen construction is contrary to the understanding of those of ordinary skill in the art in November 1984. The ordinary meaning of “integral” within the catheter industry supports a broader definition than that advocated by Defendant. 38. A person of ordinary skill in the art would have looked to the specification, the prosecution history, and the reexamination history and concluded that “integral” refers to components that are attached together or joined in some manner, forming a unit so that the two pieces move together. It does not only refer to a structure that is made in one piece, laterally displaced, or arranged side-by-side in a “dual-lumen” formation. There is no language in the claims or in the prosecution history that precludes a coaxial construction. 39. During the reexamination proceedings, the examiner cited the Simpson-Robert article and the Leary patent interchangeably in discussing the scope of the prior art. The examiner therefore treated the ’129 patent claims as commensurate in scope with either a coaxial or dual-lumen construction. 40. The examiner referred to a tube construction where two tubes are glued together as an “integral” construction. The examiner stated, “Turning now to a discussion of the cited patent to Rusch. Note the first tube (6-9) integral with a second short tube 1 having a balloon 3 mounted thereon.” Reexamination File History, Information Disclosure Statement and Notice of Concurrent Proceedings (April 10, 1989) (Defendant’s Trial Exhibit 2, Tab 4, at 3). In the Rusch patent, the two tubes are glued together. 41. The Detailed Description of the Invention describes a “one piece” construction of the claimed catheter. It states, “The tube 3 [the inflation tube] with its inner lumen 17 and the segment of tubing 7 [the guide wire tube] with balloon passage 8 are made in one piece in the region shown in FIG. 3.” However, nothing in the actual claims of the T29 suggests that integral means “made in one piece.” In addition, while figures 1 and 3 of the ’129 patent and reexamination certificate show a laterally displaced, one-piece, dual-lumen construction of the inflation tube and guide wire tube, the Court notes that patented claims are not necessarily limited to the specification or drawings. 42. The ’129 patent Summary of the Invention describes the claimed catheter as having an inflation tube “laterally displaced” from the guide tube. It also states that the inflation tube “no longer encloses the guide wire and the guide tubing enclosing it.” SciMed argues that this language precludes a co-axial construction. Again, however, nothing in the claims suggests that the patent is limited to a co-axial construction. During the second preliminary amendment of the original prosecution history, in proposed Claims 9 and 10, Schneider used “integral” in the independent claim to indicate a construction broader than “laterally displaced and molded,” which appeared in the dependent claim. 43. In the drawing of the ’129 patented invention, a marker band goes around the stabilizing wire. A reasonable interpretation of the drawing is that the wire is held onto the tube by the clamping of the marker band. In claim 3 of the patent, this stabilizing wire is called “integral.” 44. In the reexamination file history, the examiner stated “Although the patentee also adds stiffness by stabilizing member [four], this stabilizing member is an integral part of the tube, while mandrin [sixteen] of Borisenko is not part of the tube [twelve].” Reexamination File History, Office Action in Merged Reexamination (Oct. 26, 1990) (Defendant’s Trial Exhibit 2, tab 24, at 18). This portion of the file history indicates that the stabilizing means disclosed in the Bonzel patent is integral. 45. According to Dr. Solar, an expert witness at trial, “integral” has a broader ordinary meaning within the catheter industry than that advocated by SciMed. In accordance with his expert testimony, the Court finds that “integral” in the claims of the ’129 patent necessarily includes co-axial catheters and catheters not made in one piece, as long as the elements of the catheter are somehow attached or bonded together. 46. The Court finds other evidence that the ordinary meaning of “integral” is consistent with Schneider’s definition. SeiMed’s attorney, James Young, received advice from a German translator that, in the original German text of the priority application, the two tubes did not have to be manufactured as one piece. The translator indicated that the German word “angeformt,” which was used in the original text, means “could be made in one pass or by subsequent assembly” and “indicates some ass[embl]y (not one piece).” (Plaintiffs’ Trial Exhibit 607). 47. The term “integral” has a fundamentally different meaning than “formed integral,” which is illustrated by U.S. Patent 4,582,181 to Samson for the Hartzler catheter (“ ’181 patent”). In describing the construction of the shaft and balloon from one piece of material, the ’181 patent at Column 2, lines 30-31, states that “the balloon is formed as an integral part of the tubular member by distending a portion of the wall.of the member.” This catheter also contains a guide wire adhesively bonded to the tubular member. Such an arrangement is referred to as an “integral” guide wire in the patent. 48. During the prosecution of ACS’s Simpson-Robert patent, U.S. Patent No. 4,323,071, the PTO initially construed the term “integral” to mean “attached” in rejecting the claims over the Gruntzig patent. ACS was able to distinguish its invention over this reference by drawing a distinction between the term “integral” (meaning “attached”) and the term “formed integral” (meaning “made in one piece”). 49. The ordinary meaning of “integral” within the catheter industry, as well as the way in which the term was used in the reexamination proceedings, convinces the Court that one of ordinary skill in the art would not limit “integral” in the 129 patent to a dual-lumen, one-piece construction. (ii) The “Relatively Short”/“Substantially Distal” Limitations 50. A person of ordinary skill in the art would have looked to the 129 patent specification, the reexamination history, and the prosecution history and concluded that the catheter claimed in the 129 patent and reexamination certificate as having a “relatively short” guide lumen with its proximal opening “substantially distally of the proximal end” of the inflation tube does not limit the guide lumen to “about the length of the balloon.” 51. The 129 patent covers various guide wire lumen lengths. It does not contain a narrow definition of the term “relatively short.” Rather, the patent refers to various relative distances. The language, “about as long as the balloon,” appears in the Summary of the Invention, but it does not appear in any of the claims of the 129 patent. Similarly, the figures of the 129 patent and reexamination certificate show the guide wire lumen as being about the length of the balloon. Again, however, the figures are merely examples of the Bonzel invention. 52. The claim language suggests that “relatively short” covers any guide wire tube that is at least about as long as the balloon, but is limited to a length less than the full length of the catheter. The second tube (guide wire tube) must be “relatively short” compared to the “relatively long” first tube (inflation tube). As long as the dilatation catheter can be rapidly exchanged over a standard-length guide wire, the guide wire tube is “relatively short.” This interpretation of the ’129 patent is consistent with the primary object of the invention, which is rapid exchange over a standard-length guide wire. To further the purpose of the invention, the guide wire lumen must be short enough so that one person can hold both ends of the wire. As long as the guide wire is equal to or less than approximately 55 or 50 centimeters, the guide wire lumen is sufficiently short to facilitate a rapid exchange. 53. In determining whether the ’129 patent limits the guide wire lumen to “about the length of the balloon,” Judge Ingram stated, “Plaintiff argues that the second tube is positioned substantially distally to the first tube because the second tube does not begin until 110 centimeters away from the proximal end of the first tube. The court agrees with Plaintiff.” Schneider (Europe) v. Advanced Cardiovascular Systems, Inc., No. C-88-20742-WAI at 7 (N.D.Cal.1990). Judge Ingram’s order is included in the file history of the reexamination. See Reexamination File History, Exhibit 10 Accompanying Response to Final Office Action of December 26, 1989 (Feb. 20, 1990) (Defendant’s Trial Exhibit 2, Tab 13A, Exhibit 10, at 7). 54. One of the objects of the ’129 patent is to reduce friction. SeiMed claims that “relatively short” must mean “only about as long as the balloon” because, at that length, the friction in the system is reduced to the maximum extent. The ’129 patent specification, however, does not state that the invention completely reduces friction. It merely states that friction is reduced to some extent. (in) The “First Tube” and “Sufficient Stiffness” Limitations 55. Each of the asserted ’129 patent and reexamination certificate claims requires that the inflation tube have “sufficient stiffness that the [guide wire] tube and expandable balloon can readily be advanced or withdrawn in use along the guide wire by exerting a pushing or pulling force upon the [inflation tube].” 56. A person of ordinary skill in the art would have looked to the specification, prosecution history, and the reexamination history and concluded that a tube can have “sufficient stiffness” even if it is constructed of several materials and pieees to achieve the requisite “sufficient stiffness.” 57. The claim language in the 129 patent does not limit how the first tube is made as long as it has “sufficient stiffness” to advance the second tube (guide wire tube) and the expandable balloon. The inflation tube can be of “sufficient stiffness” even if it is constructed of several pieces. This is true even if the individual pieces making up the first tube do not, by themselves, perform the required functions of the claimed “first tube.” (iv) The “Stabilizing Wire” Limitation 58. Claims 3, 7, and 10 of the 129 patent and reexamination certificate require that the inflation tube be reinforced by means of a “longitudinally-extending stabilizing means.” Claims 3 and 10 further require that the “longitudinally-extending stabilizing means” be “integral” and “non-removable.” The stabilizing wire stiffens the inflation tube. 59. There is no limitation in the 129 patent regarding how the “stabilizing wire” is connected to the inflation tube. One of ordinary skill in the art in November 1984 would have looked to the specification, the prosecution history, and the reexamination history and concluded that the wire can be “integral” if it is glued, forced into a tight hold, or extruded. (v) Scope of Coverage of the T29 Patent Claims 60. SciMed argues that Schneider’s own rapid-exchange catheters are not within the scope of the 129 patent because they contain elements not covered by the 129 patented claims. For example, some of Schneider’s rapid-exchange catheters have guide wire lumens longer than “about the length of the balloon.” The Court rejects this argument based on the claim construction set forth above. 61. The length of the guide wire lumen on Schneider’s rapid-exchange catheters has varied in length from 5 centimeters to 17 centimeters. SciMed alleges that any catheter, including Schneider’s own products, with a guide wire lumen longer than the length of the balloon, is not covered by the 129 patent. 62. Mr. Kagan testified that the ACS RX™ catheter does not infringe the 129 patent because of the length of its guide wire tube (25 centimeters). In a report Mr. Kagan wrote in 1990, however, he stated, “ACS RX catheter. First filed in 1986. RX as currently marketed appears to infringe on Bonzel.” Novel Biomedical, Inc. and TFX Medical, “Percutaneous Transluminal Coronary Angioplasty Patent Search and Evaluation Overview,” March 27, 1990, at 7 (Plaintiffs’ Trial Exhibit 1052). Mr. Kagan wrote this report before he was hired by SciMed as an expert. 63. The 129 patent covers the Schneider MONORAIL™ products, the ACS RX,™ and the SYNERGY ™ catheters because the claims of the 129 patent are not limited to guide wire lumens that are “about the length of the balloon.” Nor are the claims of the 129 patent limited to a dual-lumen construction. B. The Structure of the EXPRESS™ and the RALLY™ (i) The EXPRESS ™ 64. The SciMed EXPRESS™ is a balloon dilatation catheter designed by SciMed for use in PTCA procedures. The overall length of the EXPRESS™ is 135 centimeters. The EXPRESS™ catheter incorporates a stainless steel hypotube segment approximately 105 centimeters long. The guide wire lumen is 35 centimeters long. The distal end of the hypotube is soldered to the proximal end of a stainless steel crimp segment. The crimp segment is glued to a polyethylene outer distal shaft, a polyethylene inner distal shaft, a sheath, and an approximately 5 centimeter push coil. The inner distal shaft and outer distal shaft are glued as part of this assembly for a length of about .5 centimeters at their proximal ends. 65. The distal end of the outer distal shaft is glued to the proximal end of the balloon. The guide wire tube traverses the interior of the balloon from the proximal end to the distal end of the balloon. The guide wire tube is sealed to the balloon by an adhesive bond on the distal end of the balloon. The distal outer shaft and the guide wire tube are coaxial for their entire length, except for the approximately .5 centimeter exit port where the guide tube exits the catheter. 66. The EXPRESS ™ balloon is made of Polyolefin Copolymer (or “POC”), which is a compliant material that stretches to defined diameters upon inflation to specified pressures. The balloon is elongated in the longitudinal direction and exhibits a substantially cylindrical central working surface between distal and proximal conical sections when inflated. (ii) The RALLY™ 67. The SciMed RALLY™ is a balloon dilatation catheter designed by SciMed for use in PTCA procedures. The overall length of the RALLY™ is 135 centimeters. The length of the guide wire tube is 3.5 centimeters. The guide wire tube, which is made from polyethylene, traverses the interior of the balloon from the distal end to the proximal end of the balloon. 68. The inflation tube on the RALLY™ incorporates a stainless steel hypotube segment approximately 105 centimeters long and a polyethylene outer distal shaft bonded to the distal end of the hypotube. The inflation medium used to inflate the balloon is passed through the hypotube and the outer polyethylene tube to the balloon. The polyethylene outer distal shaft of the RALLY ™ is crimped at its distal-most end. The polyethylene outer distal shaft is glued to both the guide wire tube and the proximal end of the balloon. 69. A stainless steel core wire is brazed to the distal end of the hypotube and extends through the polyethylene outer distal shaft and into the middle of the balloon, where it is glued to the marker band on the guide wire tube. 70.The RALLY™ balloon is made of the same POC material as the EXPRESS™ balloon. The balloon is elongated in the longitudinal direction and exhibits a substantially cylindrical central working surface between distal and proximal conical sections when inflated. C. Literal Infringement (i) The EXPRESS ™ 71. The EXPRESS ™ meets every element of the ’129 patent claims in dispute. 72. All of the claims of the 129 patent and the 129 reexamination certificate require that the guide wire tube be “integral” with the inflation tube of the catheter. “Integral” refers to components which are attached together or joined in some manner, forming a unit so that the two pieces move together. The EXPRESS ™ has a guide wire tube that is integral with its inflation tube because its components are attached or joined in a manner such that the pieces of the unit move together. The two tubes on the EXPRESS™ are bonded together such that pushing on the inflation tube moves the guide wire tube. 73. The guide wire tube is not “about the length of the balloon” since the balloon is approximately 30 millimeters long. The 129 reexamination certificate at Column 1, Lines 35-45, however, refers to a “second, relatively short, elongated hollow tube ... terminating at its proximal end substantially distally of the proximal end of the [inflation] tube.” The critical question, therefore, is whether the guide wire tube on the EXPRESS ™ is relatively short compared to the length of the inflation tube, as opposed to whether the guide wire tube is about the length of the balloon. The Court finds that the guide wire tube on the EXPRESS ™ (35 centimeters) is relatively short compared to the length of the relatively long (135 centimeters) inflation tube. 74. The EXPRESS™ has an inflation tube that is a combination of several elements. The inflation tube opens at its distal end into the interior of the balloon. The outer distal polyethylene shaft does not alone possess sufficient stiffness to advance the distal end of the catheter. However, when the combination of elements that form the inflation tube receive a pushing or pulling force, the balloon and guide wire tube are readily advanced or withdrawn together, in use, along the guide wire. The EXPRESS ™ brochure actually states that the plastic or polyethylene distal shaft transmits push to the lesion. 75. The SciMed marketing brochure for the EXPRESS™ instructs the cardiologist to use the EXPRESS™ with the wire first technique. In this technique, the guide wire is first inserted into the patient and located at the stenosis. The EXPRESS ™ is then backloaded onto the guide wire and advanced to the stenosis. This procedure literally infringes the steps in method Claims 5, 6, 9,10, 22, 23, 24, 25, and 26. 76. SciMed’s brochure for the EXPRESS ™ also teaches rapid exchange over a standard-length guide wire. This procedure literally infringes method Claims 17,18, 19, 20, and 21. (ii) The RALLY™ 77. The RALLY™ meets all of the disputed elements of the claims of the ’129 patent and reexamination certificate as construed above. 78. The RALLY’S™ guide wire tube is integral with its inflation tube. The two tubes are bonded together such that when a pushing or pulling force is applied to the inflation tube, the guide wire tube moves in response. A combination of elements creates an inflation tube in the RALLY™. 79. Specifically, the inflation tube is a combination of a stainless steel hypotube shaft and a distal polyethylene shaft. It opens at its distal end into the interior of the balloon and possesses sufficient stiffness, when actually used, to advance the distal end of the catheter. 80. The guide wire tube (3.5 centimeters) is relatively short compared to the relatively long (135 centimeters) inflation tube. As SciMed concedes, even under its definition of “relatively short,” which is “about the length of the balloon,” this element of the claim is met. 81. The inflation tube of the RALLY™ catheter is “reinforced by means of longitudinally extending stabilizing means.” The stabilizing means is an “integral non-removable stabilizing means” within the meaning of the ’129 patent. 82. The instructions for use for the SciMed RALLY™ instruct the cardiologist to use the RALLY™ with the wire first technique. In this technique, the guide wire is first inserted into the patient and located at the stenosis. The RALLY™ is then backloaded onto the guide wire and advanced to the stenosis. This procedure literally infringes the steps of method claims 5, 6, 7, 9, 10, 22, 23, 24, 25, and 26. SciMed’s instructions for use for the RALLY ™ also teaches rapid exchange of the RALLY™ over a standard-length guide wire. This procedure literally infringes method claims 17, 18, 19, 20, and 21. D. The Doctrine of Equivalents (i) The “Integral” Limitation 83. Dual-lumen and coaxial rapid exchange catheters perform the same function in a similar manner to produce the same result. Thus, the coaxial structures in the EXPRESS™ and RALLY™ are substantially equivalent to the dual-lumen construction disclosed in the ’129 patent. 84. The inflation tube and the guide wire tube of the EXPRESS™ and the RALLY™ are bonded or attached together to form a unit. As in the one-piece construction in the example in the ’129 patent, the bonded tubes of the EXPRESS™ and RALLY™ allow an operator to push on the first tube to move the second tube. Thus, the bonded nature of the EXPRESS™ and RALLY™ is substantially equivalent to the structure shown in the 129 patent. (ii) The “Relatively Short”/“Substantially Distal” Limitations 85. To perform the same function (single operator exchange) and obtain the same re-suit (more efficient, faster PTCA procedure) as the catheter claimed in the 129 patent, the EXPRESS™ and the RALLY™ catheters have a relatively short guide wire tube compared to the inflation tube. This structure allows a cardiologist to easily and rapidly exchange catheters during a PTCA procedure. It is substantially the same, if not identical, to that used in the claimed invention of the 129 patent. (in) The “First Tube” Limitation 86. In both the EXPRESS ™ and RALLY ™ catheters, the function of the inflation tube is to receive inflation fluid and discharge the fluid into the interior of the catheter balloon. Passing inflation fluid through the inflation tube expands the catheter balloon to clear the artery. The function performed and result accomplished by the inflation tube in the EXPRESS™ and RALLY™ catheters are the same as in the claimed invention of the 129 patent. 87. The 129 patented invention performs the inflation function with a hollow tube that extends from the proximal end to the distal end, terminating at the interior of the catheter balloon. Similarly, the aggregated segments of the EXPRESS™ catheter are bound together to form a hollow structure that receives inflation fluid and discharges the fluid into the interior of the catheter balloon. The RALLY™ catheter is also functionally equivalent to the 129 patent because the hypotube segment and the tubing shaft segment are bound together to form a hollow, tubular structure, through which the catheter balloon is inflated. (iv) The “Sufficient Stiffness” Limitation 88. The EXPRESS™ and RALLY™ catheters perform the same function to obtain the same result as the catheter claimed in the 129 patent. In the 129 patent, the guide wire tube and expandable balloon advance or withdraw when the inflation tube receives a pushing or pulling force. SeiMed catheters work in substantially the same way. The combination of elements forming the first tube, when receiving a pushing or pulling force, readily advance or withdraw the guide wire tube and the expandable balloon along the guide wire in the same way as the catheter claimed in the 129 patent. (v) “Integral Stabilizing Means” 89.Relying on the expert testimony of Dr. Solar, the Court finds that the core wire of the RALLY ™ catheter performs substantially the same function as the “stabilizing means” requirement of Claims 3, 7, and 10 of the 129 patent and reexamination certificate. III. Validity A. One of Ordinary Skill in the Art 90. One of ordinary skill in the art on November 23, 1984 (the 129 patent’s effective filing date) was a practicing interventional cardiologist who performed dilation or coronary angioplasty dilatation procedures. Persons of ordinary skill in the art included knowledgeable PTCA practitioners, such as Dr. Robert Meier and Dr. Robert Van Tassel, who offered credible testimony at trial in support' of Schneider’s definition. 91. SeiMed argued throughout trial that one of ordinary skill in the art was an engineer working in the area of dilatation catheter design or a physician who had an understanding of and skill in the design of dilatation catheters. The Court expressly rejects SciMed’s proffered definition. B. Scope and Content of Prior Art/Differences Between the Prior Art and the Claims at Issue (i) Scope of the Relevant Prior Art 92. The 129 patent specification defines a dilatation catheter as a catheter “employed to enlarge constrictions in vessels and body cavities, in particular coronary arteries.” During the reexamination proceedings, Schneider (Europe) acknowledged that some claims in the 129 patent were broadly directed to “dilatation catheters,” while others were specific to vascular and coronary dilatation catheters. 93. The subject matter of the 129 patent invention relates to balloon dilatation catheters. As the patent examiner found, PTA and PTCA practitioners in 1984 would have had little, if any, exposure to non-dilatation medical devices, such as emboleetomy, esophageal, thrombectomy, and urology catheters. The scope of relevant prior art is therefore limited to balloon dilatation catheters. 94. SciMed argued at trial that various prior art references, both inside and outside the balloon dilatation catheter field, are relevant and render the Bonzel invention obvious. The most arguably relevant of these references, which are identified below, were before the patent examiner during the reexamination. The only devices listed below that were not before the patent examiner are the perfusion catheter references. (ii) Content of the Alleged Prior Art/Differences Between the Prior Art and the Claims at Issue (a) Borisenko 95. The Borisenko Russian Inventor’s Certificate No. 627,828 (1978) (“Borisenko”) describes a thrombectomy catheter for removing occluded blood clots from main vessels, such as veins. Thrombectomy catheters, such as the Borisenko device, cannot not be used in the coronary arteries or in PTCA procedures. 96. PTCA catheters have balloons made of inelastic materials that assume a controlled, cylindrical shape when inflated. They are not performed with catheters having elastic balloon material because elastic balloons do not inflate to a predetermined size and shape. Instead, they tend to assume the shape of the vessel upon inflation. The soft elastic balloon disclosed in Borisenko does not hold a high enough pressure to compress a stenosis against the coronary artery wall. The occlusion balloon on the tip of the Borisenko catheter, if used in the coronary arteries, would be dangerous to the patient because it would stop blood from flowing through the artery to the heart muscle tissue downstream. In addition, the balloon in Borisenko has a reinforcing ring on its outer circumference, which is not used on PTCA catheter balloons. 97. The Borisenko device, like other thrombectomy devices, does not use a PTCA guide wire or PTCA guide wire lumen. Thus, Borisenko does not disclose a first relatively short tube for receiving a guide wire in a sliding fit, which is a required feature of the ’129 patent. It does, however, possess a short guide lumen. 98. The Borisenko reference does not disclose a method for exchanging catheters. Any effort to exchange Borisenko’s slider, balloon, and connecting tube would require the deflation of the balloon and the dismantling of the entire device during the procedure. Because the exchange could result in thrombus particles entering the circulatory system, such an exchange is not performed. 99. The Borisenko reference is a two-operator system. According to Borisenko, “By drawing up the guide tube 1, the mouth of the vena iliaca is closed off, and the tube is secured by the hand of the assistant.” Borisenko et al., Russian Inventor’s Certificate No. 627,828, at 2. 100. Modifying the Borisenko device into a PTCA catheter would involve changing the balloon material and the guide wire, inserting a guide wire lumen, removing the reinforcing ring on the balloon, and changing the balloon’s shape. The Court finds that the Borisenko reference would not motivate one of ordinary skill in the art to invent the claimed invention. (b) Nordenstrom 101. The Nordenstrom articles, “Balloon Catheters For Percutaneous Insertion Into the Vascular System” and “New Instruments For Catheterization And Angiocardiography,” published in 1962 and 1965 respectively, describe a single lumen angiography catheter for diagnostic investigation of blood vessels and heart cavities. The Nordenstrom catheters were not designed for dilatation in a PTCA procedure or for any other therapeutic purpose. 102. Figure 1 of the 1962 Nordenstrom article discloses a series of occlusion balloon catheters with soft elastic balloons for percutaneous insertion into vessels for diagnostic occlusion. The main advantage taught by Nordenstrom is the ability to introduce the catheter percutaneously into a vessel with a guide wire. The article contains no diselosure of catheter exchange or rapid exchange. The 1962 Nordenstrom device is not used in the coronary arteries. 103. Prior to the 1962 and 1965 articles, the ability to inject a large amount of contrast dye into a cavity using a catheter that was blocked at the distal end was important. This function improved the visibility of the cavity on an X-ray machine. A catheter with a blocked distal end is not capable of receiving a guide wire to maintain the catheter access in the vessel. Dr. Nordenstrom solved this problem, as discussed in his 1962 and 1965 articles, by adding a short segment to the end of the catheter distal to the balloon, thereby allowing the use of a guide wire. Thus, Nordenstrom’s catheters possessed a short guide lumen. 104. The problem that motivated Dr. Nordenstrom to design the catheter described in his articles was not the same problem encountered by PTCA practitioners in 1984. A PTCA procedure in 1984 used a guiding catheter to maintain access to the puncture site. Doctors already knew how to introduce balloon catheters percutaneously, as Dr. Wholey and Mr. Kagan conceded. The percutaneous access method taught by Nordenstrom, therefore, was not needed in 1984. 105. Nordenstrom does not teach that the guide wire lumen should be moved into the interior of the balloon or that the catheter should be used with a guiding catheter, which are features required by the ’129 patent. In addition, as disclosed in the 1965 Nordenstrom article, the guide wire is removed prior to injection of contrast medium. 106. The “exchange” procedure set forth in the 1965 Nordenstrom article includes the following steps: 1) the catheter is pulled back; 2) a wire is placed next to the catheter; 3) the catheter is completely removed; and 4) a new catheter is inserted. This procedure is followed to keep the puncture-site open and thereby maintain access to the artery. This motivation was irrelevant in PTCA in 1984 because guiding catheters were used, which eliminated the problem of keeping the entrance to the artery open. 107. The 1966 Nordenstrom article discloses a device comprised of two catheters— an angiography catheter with no balloon or inflation tube and a balloon occlusion catheter. 108. The Court concludes that Nordenstrom would not have motivated one of ordinary skill in the art in 1984 to invent the rapid-exchange catheter disclosed in the ’129 patent. (c) Morton 109. A 1912 book by Dr. Henry H. Morton discloses a device called a “tunneled sound.” This type of device is not a balloon catheter, but a device referred to as a “dilator.” It was designed for dilating strictures in the urethra, not for use in the coronary or peripheral arteries. The instrument has a short lumen at its distal end for receiving a guide. In use, a guide is first passed through the stricture into the bladder. The instrument is passed over the guide and through the stricture to dilate it. While the guide is in place, the first catheter is withdrawn and a second, longer catheter is inserted over the same guide to further dilate the stricture. See Dr. Henry H. Morton, Genitourinary Diseases and Syphilis (3d ed. 1912). 110. The device disclosed in Morton is a surgical device that must be used with a knife, unlike a PTCA procedure, which in non-invasive. The procedure takes 18 months to complete. In 1984, a PTCA procedure took approximately 25-35 minutes. 111. None of the devices shown in the Morton reference have balloons or tubes for inflating balloons. In addition, dilating by placing increasingly large solid dilators through a constriction was rejected as a technique in PTCA in 1984. The stenosis treated in Morton is a different type of stenosis than the type treated in PTCA. Using the technique shown by Morton in a PTCA procedure would cause the stenosis to be pushed forward, producing a “snowplow” effect. 112. The tunnelled sounds illustrated in Figures 93, 97 and 98 of Morton’s book are used in combination with a device referred to as a “filiform whalebone guide.” There is no separate tube or lumen inside these tunnelled sounds through which the guide slides. In fact, there is no lumen at all inside the tunnelled sound. Rather, the sounds contain grooves on their exterior surfaces, over which the guide passes. 113. Morton would not have motivated one of ordinary skill in the art to invent the monorail-type catheter. (d) Esophagal Devices 114. The Jameson reference, dated 1822, discloses a device having a metal dilator for dilation in the esophagus. See Dr. H.G. Jameson, “An Account of a Case of Stricture of the Esophagus,” The Medical Recorder, January 1822. The device does not have a balloon or a hollow inflation tube. The procedure shown in the Jameson reference takes over two months, which is much longer than that required for a PTCA procedure in 1984. 115. An article by Dr. Keshishian discloses a device referred to as a “JacksonPlummer metal olive dilator” for dilation in the esophagus. The device did not have a hollow inflation tube or a balloon. See Dr. John M. Keshishian, “Dilatation of Difficult Strictures of the Esophagus,” 1984. 116. Both of these devices teach the use of a short guide wire lumen for guide wire first operation and exchange. However, neither of these references would have motivated one of ordinary skill in the art to invent a rapid-exchange catheter. (e) Hartzler 117. The Hartzler catheter had a guide wire fixed in the catheter running the length of the catheter (FWC). There was no separate guide wire lumen. Testimony at trial suggested that the Hartzler catheter was a catheter of “last resort,” to be used when no other catheter could cross a lesion. It was not used routinely because distal pressure measurement and distal dye injection could not be performed. Knowledge of the Hartzler catheter would not have motivated one of ordinary skill in the art to create a monorail catheter. (f) Perfusion Catheters 118. A perfusion catheter, such as that disclosed by Erbel, is an OTW dilatation catheter that contains a series of small holes on either side of the balloon. See Erbel, “A Newly Developed Balloon Catheter for Reduction of Myocardial Ischemia During Transluminal Angioplasty,” September 1984. The balloon- is located at a stenosis and then inflated. The guide wire is partially withdrawn to uncover the holes, which goes against Bonzel’s teachings that the guide wire should remain in place. Blood then flows through the guide wire lumen. The guide wire remains inside the full-length guide wire lumen throughout the procedure. The Erbel article does not mention exchange of catheters or use of the wire-first technique. 119. The Erbel perfusion catheter has a full-length guide wire lumen, but it does not provide distal pressure measurement or distal dye injection. Erbel sacrificed these features to achieve perfusion capability. Modifying the catheter by placing the guide wire through the perfusion holes to create a short guide wire lumen would have destroyed the purpose of Erbel’s device, which is to perfuse blood during a PTCA procedure. As a result, Erbel would not have motivated one of ordinary skill in the art in 1984 to invent the rapid-exchange catheter. (g) Kaltenbach 120. The December 1984 Kaltenbach article, “The Long Wire Technique — A New Technique For Steerable Balloon Dilatation Of Coronary Artery Stenosis,” teaches a wire first technique using a 300 centimeter guide wire and a conventional OTW catheter. It does not teach this technique'using a standard-length guide wire. Rather than shortening the guide wire lumen to effectuate an exchange, Kaltenbach taught using a longer guide wire, which is why it is called the “long wire technique.” The Court finds that Kaltenbach would not have motivated one of ordinary skill in the art to invent the patented catheter. (h) Leary 121. When references having a short guide wire lumen are combined with conventional OTW catheters in the PTCA field, such as the U.S. Patent Number 4,545,890 to Leary, teachings of distal dye injection and distal pressure measurement must be discarded because the full-length guide wire lumen is eliminated. Since none of the references cited by SciMed specifically teach how Leary can be modified to include a short guide lumen without destroying its intended function, and since the conventional wisdom among those of ordinary skill in the art in 1984 was that distal dye injection and distal pressure measurement were