Full opinion text
MEMORANDUM ORDER LARSON, Senior District Judge. INTRODUCTION The matter before the Court began in 1979 as a relatively straightforward patent infringement action. In the six years which followed, however, the matter proliferated such that almost every federal district judge in Minnesota was involved in this matter at one time or another; the matter spawned related actions in Texas and Florida which now have been stayed pending this decision or transferred to Minnesota for decision; and the matter attracted the keen attention and required the significant investment of time, money, and effort of a number of corporations in the competitive field of pacemaker pulse generators and pacemaker leads. Now, in 1985, the Court, having given its careful consideration to the matter, hopes to render a decision which will show the matter to be the straightforward patent infringement action it is, and signal the beginning of the end for this unnecessarily protracted and unduly complicated litigation. Medtronic, Inc. and its wholly owned subsidiary Medtronic Puerto Rico, Inc. (Medtronic) commenced this patent infringement action against Daig Corporation (Daig) on May 29, 1979 in the United States District Court for the District of Minnesota. The action was assigned to Judge Harry H. MacLaughlin under Civil No. 4-79-256. Medtronic alleged that Daig had infringed the claims of its assigned United States Patent No. 3,902,501 (’501 patent) and No. 3,737,579 (’579 patent). Medtronic requested that Daig be enjoined from infringing the ’501 and ’579 patents and account for and pay damages which resulted from Daig’s infringement. Medtronic also asserted that Daig’s infringement was willful, deliberate, and intentional and requested that the damages be trebled. On July 18, 1979, Daig filed its Answer and Counterclaim and, on February 23, 1981, Daig, with leave of court, filed its Amended Answer and Counterclaim. In its Amended Answer and Counterclaim, Daig asserted the affirmative defenses that the ’501 and ’579 patents were invalid under 35 U.S.C. §§ 102, 103, and 112, that Medtronic was estopped by its actions in the negotiations and proceedings involving the ’501 and ’579 patent applications before the United States Patent and Trademark Office (PTO), that Medtronic had misused the ’501 and ’579 patents in this infringement action, and that, with respect to the ’501 patent, Medtronic had displayed a lack of candor with the PTO having failed to disclose the wedge tip pacemaker leads which Medtronic marketed commercially as Models Nos. 6901 and 6907. Daig sought declaratory judgment that the ’501 and ’579 patents were invalid; Daig also alleged that Medtronic’s conduct violated federal antitrust law, 15 .U.S.C. §§ 1 and 2, state antitrust law, Minn.Stat. §§ 325.8011-325.-8028 (renumbered Minn.Stat. §§ 325D.49-325D.66), and constituted unfair means and methods of competition. Daig requested that Medtronic’s conduct be enjoined and that Daig be awarded treble damages. On December 16, 1980, Daig commenced a separate patent infringement action against Medtronic in the United States District Court for the District of Minnesota. The action was assigned to Judge Diana E. Murphy under Civil No. 4-80-611. Daig alleged that Medtronic had infringed its assigned United States Patent No. 4,236,-529 (’529 patent) and sought injunctive relief and money damages as determined by an accounting. Medtronic filed its Answer and Counterclaim on January 12, 1981 in which it asserted the affirmative defenses of invalidity under 35 U.S.C. §§ 102, 103, and 112, file wrapper estoppel, and fraud in the procurement of the ’529 patent, and sought declaratory judgment that the ’529 patent was invalid. On January 13, 1981, the patent infringement actions, Civil Nos. 4-79-256 and 4-80-611, were consolidated for all pretrial purposes and trial before Judge MacLaughlin. These actions were subsequently reassigned to Judge Paul A. Magnuson upon his appointment to the federal bench on November 16, 1981. On June 10, 1981, a petition in involuntary bankruptcy for a liquidation proceeding under Chapter 7 of the Bankruptcy Code was filed against Daig. Daig promptly converted the proceeding to a reorganization proceeding under Chapter 11 on June 16, 1981. The infringement actions, Civil Nos. 4-79-256 and 4-80-611, were stayed pursuant to the automatic stay provisions of the Bankruptcy Code. On January 22, 1982, Medtronic commenced an adversary proceeding in the United States Bankruptcy Court for the District of Minnesota in which Medtronic sought modification of the automatic stay. The matter came on for trial before the Bankruptcy Court on March 9, 1982 and the Bankruptcy Court modified the automatic stay on April 15, 1982. The Bankruptcy Court permitted Medtronic to proceed against Daig in Civil No. 4-79-256 and to defend in Civil No. 4-80-611 to obtain an infringement determination and injunctive relief, if appropriate. Medtronic then filed a Motion for Expedited Trial Date which was denied on August 12, 1982. On October 13, 1982, Medtronic followed with a Motion for Preliminary Injunction seeking to enjoin Daig from manufacturing, using, or selling any pacemaker leads within the terms of the claims of the ’501 patent. Daig responded with its Motion to Stay on November 17, 1982 asking the Court to stay the litigation between Medtronic and Daig with respect to the '501 patent pending a determination of the validity of that patent in another infringement action, Medtronic, Inc. and Medtronic Puerto Rico, Inc. v. Intermedies, Inc., Civil No. G-80-295, which was then pending in the United States District Court for the Southern District of Texas. Daig, as a condition to a stay of the Medtronic litigation in Minnesota, agreed to be bound by the determination of the Intermedies litigation in Texas as to the validity of the '501 patent. On November 24, 1982, the Court denied Daig’s Motion to Stay and scheduled Medtronic’s Motion for Preliminary Injunction for January 10, 1983. Following a nine day hearing, the Court, on May 20, 1983, ordered Daig not to make, use, or sell silicone or other tined leads embodying the elements of Claim 1 of the '501 patent during the pendency of this action. On August 29, 1984, the Court, having found that the equities and the improved financial condition of Daig warranted lifting the injunction, vacated the preliminary injunction conditioned upon the ability and willingness of Daig to comply with an escrowed royalty arrangement with Medtronic. On August 21,1981, Pacesetter Systems, Inc. (Pacesetter) commenced a declaratory judgment action against Medtronic in the United States District Court for the Central District of California. Pacesetter sought to have the ’501 patent declared invalid and not infringed by Pacesetter. The action was transferred to the United States District Court for the District of Minnesota on February 11,1983 where it was assigned to Judge Donald D. Alsop under Civil No. 3-83-251. Medtronic filed its Answer and Counterclaim on March 28,1983 and asserted that Pacesetter had willfully, deliberately, and wantonly infringed the ’501 patent. Medtronic sought injunctive relief and treble money damages. This action, having been found to be a companion case to Civil Nos. 4-79-256 and 4-80-611, was reassigned to Judge Magnuson on June 13, 1983. Pacesetter, like Daig, filed a Motion to Stay on May 27, 1983 asking the Court to stay discovery and trial pending a final determination of the validity of the ’501 patent in Medtronic, Inc. and Medtronic Puerto Rico, Inc. v. Intermedies, Inc., Civil No. G-80-295, which was pending in the United States District Court for the Southern District of Texas. As a condition to a stay of the proceedings in Minnesota, Pacesetter agreed to be bound by the determination of the validity of the ’501 patent in the Intermedies litigation in Texas. On August 5, 1983, Pacesetter, following a determination in the Intermedies litigation that the ’501 patent was valid and infringed, withdrew its Motion to Stay. Medtronic then brought a Motion for Preliminary Injunction which was denied on August 30, 1983. Medtronic and Pacesetter later brought Cross-Motions for Summary Judgment which were denied on April 18, 1984. The Court, having determined that the issues of patent validity and infringement in Civil No. 3-83-251 involved common questions of law and fact with the issues of patent validity and infringement in consolidated Civil Nos. 4-79-256 and 4-80-611, consolidated Civil Nos. 3-83-251, 4-79-256, and 4-80-611 for trial. The Court then ordered the trial trifurcated with the issues of patent validity and infringement to be tried to the Court first, the issues of damages relating to patent infringement to be tried to the Court next, and the issues of liability and damages relating to the antitrust and unfair competition claims to be tried to a jury last. Trial commenced before Judge Earl R. Larson on February 14, 1985 and continued, with only the interruption of a classic Minnesota blizzard, until its conclusion on March 20, 1985. The Court heard and received evidence with respect to Claim 1 of the ’501 patent only. Essentially, the consolidated actions before the Court were Civil Nos. 4-79-256 and 3-83-251. Remaining issues await trial another day. This Memorandum Order comprises the findings of fact and conclusions of law of the Court pursuant to Rule 52(a) of the Federal Rules of Civil Procedure. This Order is the product of careful and detailed attention to the witnesses and evidence presented and the numerous legal issues raised. Where conflicts existed in the testimony, and conflicts there were, facts have been found on the basis of close observation of the appearance, conduct, and demeanor of the witnesses, and scrutiny of contemporaneous documentation or exhibits, if available. PATENT IN SUIT At issue in this trial is the validity of United States Patent No. 3,902,501 (PX 1) entitled “Endocardial Electrode.” Paul Citron and Eugene A. Dickhudt are the inventors of this endocardial electrode and they assigned their interest in it to Medtronic. Their patent application was filed on June 21, 1973 and the ’501 patent was issued on September 2, 1975. This endocardial electrode, or tined lead, provided a unique means of passively fixing a medical electrode to heart tissue, particularly the trabeculae of the ventricles and the right atrial appendage. The new lead employed a plurality of pliant nonconducting tine means adjacent to the electrode tip to cooperate with the heart tissue. The pliant nonconducting tines offered a more effective way of passively fixing the lead to heart tissue until natural fixation or fibrosis could occur and without damaging the affected venal or heart tissue. The ’501 patent specifically claimed: 1. In an endocardial lead of the type having an electrical conductor encased in a material which is generally inert to body fluids, the conductor terminating at an exposed electrically conductive electrode tip, the improvement which comprises: nonconducting tine means extending from said encasing material and away from said tip from a location adjacent said tip for cooperating with heart tissue, to hold the tip in position, said tine means forming a generally acute angle with said encasing material and being entirely of a pliant material having sufficient rigidity to maintain said angle when said tine means are unrestrained, but sufficiently pliant to prevent penetration of said heart tissue, said pliant material being generally inert to body fluids. (PX 1, column 6, lines 50-66). Claim 1 is the only claim of the ’501 patent in dispute here. Paul Citron came to Medtronic in February 1972 with a bachelor’s degree and a master’s degree in electrical engineering to develop an atrial pacing system. With essentially no experience in pacing, but with the background of a self-described hybrid masters program involving medical and veterinary courses in anatomy and physiology, Citron pondered his task. He studied the anatomy of the human heart, the literature involving atrial pacing, and the available technology. The study of his task made clear to him that the problem then confronting atrial pacing was twofold. First, the pacemaker or pulse generator, the device which both senses the rate and amplitude of electrical impulses of the heart and stimulates the heart with a self-generated electrical impulse to restore an acceptable heart rate, was itself a problem involving the capability of the pulse generator to sense accurately the electrical activity of the heart and to stimulate properly the heart as necessary. Second, the lead system, the means by which the pulse generator senses the electrical impulses of the heart and transmits stimulating electrical impulses to the desired location in the heart, was a problem because no reliable atrial pacing lead system existed. The absence of a reliable atrial pacing lead system, in Citron’s opinion, was of paramount concern and on that problem he focused his attention and energy. While no reliable atrial pacing system existed in 1972, a variety of epicardial or myocardial leads and endocardial or transvenous leads, commonly used in ventricular pacing, had been used in atrial pacing. Epicardial leads, which were actually attached to the outer surface or the epicardium or myocardium of the heart, included a screw-on lead (PX 29) and a suture-on lead (PX 28). A screw-on lead was actively fixed within the myocardium in a corkscrew-like fashion. A suture-on lead was actively fixed to the myocardium with silk sutures. The fixation of epicardial leads required one of three significant surgical procedures, including a major thoracotomy, a minor thoracotomy, or a subxiphoid approach. The major surgery necessary for the fixation of epicardial leads was a major disadvantage of epicardial leads because of the attendant trauma and risks of major surgery and the extended recuperation time. Endocardial or transvenous leads, which were positioned within the heart by insertion through a vein, included a straight-shank lead, a wedge tip or flange lead (PX 30), and a helical lead. A straight-shank lead and a flange lead were inserted transvenously into the heart and passively fixed within the trabeculae of the right atrial appendage or ventricular apex where it was hoped the lead tip would remain in contact with the endocardium. A helical lead was also inserted transvenously into the heart, but it involved a helically shaped barb or hook mechanism which was actively fixed to the endocardium by rotating the device. The placement or positioning of endocardial leads required a minor surgical procedure under local anesthesia which involved cannulating a vein and using a catheter through which the lead would be passed to the desired location in the heart. The relatively non-traumatic procedure and quick recovery time were significant advantages of endocardial leads. Endocardial leads, however, also had disadvantages involving acute dislodgement, where the electrode tip of the lead lost contact with the endocardium or wall of the heart, and perforation, where the electrode tip punctured the endocardium. Citron, along with Eugene Dickhudt, a mechanical technician for Medtronic, began to design atrial lead systems. As Citron’s laboratory notebook (PX 42) evidences, Citron and Dickhudt toyed with a number of lead designs in early 1972. Some of these lead designs included: the earthworm endocardial lead (PX 42, pp. 1-2) which was intended to allow both atrial and ventricular pacing through the same lead; the cyanoacrylate myocardial lead (PX 42, pp. 2 and 12-16) which envisioned literally gluing the lead to the myocardium; the barbed myocardial lead (PX 42, pp. 17 and 19) which used conductive fishhooks or barbs to fix the lead to the myocardium; the vacu-tach lead (PX 42, p. 17) which was intended to fix the fishhook lead to the myocardium of the atrium with a vacuum pump; the vena cava atrial lead (PX 42, pp. 20 and 24-25) which was a flat myocardial lead to be wrapped around the superior vena cava and secured with glue or sutures; and the double twang lead or endocardial s-a node electrode (PX 42, p. 26) which, upon positioning in the atrium, would bifurcate into two smaller J-shaped leads with electrode tips. On July 7, 1972, Citron entered in his lab notebook a sketch of “a new concept for an atrial endocardial lead” which he called the grapnel (PX 42, p. 50). Citron envisioned a flexible endocardial lead body with a skirt of a number of pliant silicone rubber tines which could be positioned in the right atrial appendage, and possibly the ventricles. Citron intended the tined skirt of the lead to extend approximately 45° from the axis of the lead body and to be positioned with a hold-down mechanism or with the tines free-standing. Dickhudt built the first prototype of the grapnel lead and Citron entered a picture of it in his lab notebook on July 13, 1972 (PX 42, p. 51). The grapnel would eventually come to be known as the tined endocardial lead which Claim 1 of the ’501 patent embraces. VALIDITY OF THE ’501 PATENT Presumption of Validity In order to be patentable, an invention must satisfy three explicit statutory conditions: (1) utility (35 U.S.C. § 101); novelty (35 U.S.C. § 102); and (3) nonobviousness (35 U.S.C. § 103). Graham v. John Deere Co., 383 U.S. 1, 12, 86 S.Ct. 684, 691, 15 L.Ed.2d 545 (1966). A patent once issued, however, is presumed valid and the burden of establishing that a patent is invalid rests on the party asserting such invalidity. 35 U.S.C. § 282. Section 282 “mandates not only a presumption shifting the burden of going forward in a purely procedural sense, but also places the burden of persuasion on the party who asserts that the patent is invalid.” Solder Removal Co. v. United States International Trade Commission, 582 F.2d 628, 632 (C.C.P.A.1978) (footnote omitted). That burden, which always remains with the party asserting invalidity, is to persuade the Court of invalidity by clear and convincing evidence. American Hoist & Derrick Co. v. Sowa & Sons, 725 F.2d 1350, 1360 (Fed.Cir.), cert. denied, — U.S. -, 105 S.Ct. 95, 83 L.Ed.2d 41 (1984). The only question for the Court is whether that burden has been successfully carried. Id. When the party asserting the invalidity of a patent relies only on the prior art which the PTO examiner considered, that party has the added burden of overcoming the deference due to the PTO. The PTO, through examiners of some expertise in scrutinizing and interpreting prior art references and familiarity with the level of skill in the art, is presumed to have properly performed its function of issuing only valid patents. The added burden on the challenger in this situation is to show that the PTO erred in granting the patent. Id. at 1359-60. When the party asserting invalidity offers prior art or other evidence which the PTO examiner did not consider, the deference due the PTO is reduced or eliminated because the PTO has not applied its expertise to this art and the Court, consequently, is not faced with having to disagree with the PTO. Id. The introduction of prior art which the PTO examiner did not consider does not weaken or otherwise affect the presumption of validity. The burden of persuasion remains clear and convincing evidence. That burden, however, may be met more easily when the prior art which was not considered is more pertinent than the cited art. Lindemann Maschinenfabrik v. American Hoist and Derrick, 730 F.2d 1452, 1459 (Fed.Cir.1984). Whether the uncited art is more pertinent turns on its relationship to the claimed invention. Pertinence is the touchstone with respect to the uncited art. A presumption that the examiner considered the uncited art because it is found in the classes and subclasses which the examiner searched is, therefore, unnecessary. To the extent that the examiner’s consideration of uncited art is material, the challenger incurs the additional burden of showing that the uncited prior art was not considered. The challenger can meet this added burden by showing that the uncited art is more pertinent than the cited art. Conversely, the patentee can thwart the challenger in this regard by showing that the pertinence of the uncited art is equal to or less than that of the cited art. Id. at 1460. § 102 Section 102 provides in relevant part that: A person shall be entitled to a patent unless— (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or ****** (g) before the applicant’s invention thereof the invention was made in this country by another who had not abandoned, suppressed, or concealed it. In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other. 35 U.S.C. § 102. A party asserting that a patent claim is anticipated under § 102 must establish that “each element of the claim in issue is found, either expressly described or under principles of inherency, in a single prior art reference, or that the claimed invention was previously known or embodied in a single prior art device or practice.” Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 771 (Fed.Cir.1983), cert. denied, — U.S. -, 104 S.Ct. 1284, 79 L.Ed.2d 687 (1984). The anticipating reference need not “teach” what the patent in suit teaches. Rather, it is sufficient that the claim being challenged “read on” something disclosed in the reference, i.e., all limitations of the claim are found in the reference or are “fully met” by it. Id. at 772. The Court, in considering anticipation, must first identify the elements of the claim in issue, determine the meaning of those elements in light of the specification and prosecution history, and identify corresponding elements disclosed in the allegedly anticipating reference. Id. at 771; Lindemann Maschinenfabrik v. American Hoist and Derrick, 730 F.2d 1452, 1458 (Fed.Cir.1984). When a party asserts that a prior use anticipates a patent claim under § 102(a) or (b), that party must also establish that such a use was of a complete invention, i.e., conceived and reduced to practice, and public. Coffin v. Ogden, 85 U.S. (18 Wall.) 120, 124, 21 L.Ed. 821 (1873); International Glass Company v. United States, 408 F.2d 395, 402,187 Ct.Cl. 376 (1969). Reduction to practice requires that an invention be sufficiently tested to demonstrate that it will work for its intended purpose. Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1444 (Fed.Cir.1984) (citing Barmag Barmer Maschinenfabrik AG v. Murata Machinery, Ltd., 731 F.2d 831, 838 (Fed.Cir.1984)). Reduction to practice does not require that the invention, when tested, be in a commercially satisfactory stage of development. Barmag Barmer Maschinenfabrik AG v. Murata Machinery, Ltd., 731 F.2d 831, 838 (Fed.Cir.1984). To determine whether a public use has occurred requires consideration of all the circumstances surrounding the use. TP Laboratories, Inc. v. Professional Positioners, Inc., 724 F.2d 965, 971-72 (Fed.Cir.) cert. denied, — U.S. -, 105 S.Ct. 108, 83 L.Ed.2d 51 (1984). Circumstances surrounding the use to be considered include whether payment is made for the device, whether a user agreed to use secretly, whether records were kept of progress, whether persons other than the inventor conducted tests or experiments, how many tests or experiments were conducted, and how long the testing period was in relationship to tests of other similar devices. Id. at 972. That a non-secret use of the device was made or that the device was not hidden from view is not ipso facto public use. Id. Where a party asserts that a prior invention anticipates a patent claim under § 102(g), that party must establish that such an invention is complete, i.e., conceived and reduced to practice, and not abandoned, suppressed, or concealed. Coffin v. Ogden, 85 U.S. (18 Wall.) 120,124, 21 L.Ed. 821 (1872); International Glass Company v. United States, 408 F.2d 395, 402, 187 Ct.Cl. 376 (1969). If the invention is not complete or reduced to practice, whether it was abandoned, suppressed, or concealed matters not for the inventor has nothing to offer or disclose to the public. Id. If the invention is complete or reduced to practice, however, it may be deemed abandoned, suppressed, or concealed if, within a reasonable time after completion, no steps, such as filing a patent application, describing the invention in a publicly disseminated document, or using the invention publicly, have been taken to make the invention publicly known. International Glass Company v. United States, 408 F.2d 395, 403, 187 Ct.Cl. 376 (1969). Claim 1 of the ’501 patent may be stated in terms of its elements as follows: 1. In an endocardial lead of the type having an electrical conductor encased in a material which is generally inert to body fluids, the conductor terminating at an exposed electrically conductive electrode tip, the improvement which comprises: nonconducting tine means extending from said encasing material and away from said tip from a location adjacent said tip for cooperating with heart tissue, to hold the tip in position, said tine means forming a generally acute angle with said encasing material and being entirely of a pliant material having sufficient rigidity to maintain said angle when said tine means are unrestrained, but sufficiently pliant to prevent penetration of said heart tissue, said pliant material being generally inert to body fluids. Claim 1 contemplates an improvement to an endocardial lead which increases the reliability of electrode securement and reduces the incidence of perforation. The improvement consists of the addition of a plurality of nonconductive tine means to the endocardial lead. The tine means extend from the lead body or encasing material and away from the tip of the lead. The tine means are located adjacent or near the tip of the lead and form an acute angle, such as 45°, with the lead body. The tine means are made entirely of a pliant material inert to body fluids, such as silicone rubber or polyurethane, which is sufficiently rigid to maintain the angle of the tine means when they are unrestrained, but sufficiently flexible to avoid penetration of heart tissue upon insertion and placement. The tine means are designed to hold the lead tip in electrical contact with heart tissue through cooperation with heart tissue, particularly trabeculae of the right atrial appendage or ventricles, until natural fixation or fibrosis has occurred (See PX 1, Figure 1). The elements of Claim 1 find support and correspondence in the specification and prosecution history of the '501 patent. Pacesetter contends that the ’501 patent was anticipated under § 102 in at least three ways: 1) anticipation by publication; (2) anticipation by prior use; and (3) anticipation by prior invention. Daig offers no serious argument for anticipation under § 102. According to Pacesetter, a barbed lead falling squarely within each element of Claim 1 of the ’501 patent was disclosed in a 1969 printed publication, Pacemaker Electrode, 4 Bio-Medical Engineering 383 (August 1969) (PSX 10b). This reference is prior art for purposes of § 102 because it is undisputed that the reference was published before the invention of the tined lead (July 7, 1972) and more than one year before the application for the ’501 patent (June 21, 1973). This reference, which was but a blurb relating to new products in medical instrumentation, is reprinted in its entirety as follows: PACEMAKER ELECTRODE Yitatron Medical N.V. of Holland has announced a new unipolar intracardiac catheter electrode, type MIP 135, for long term stimulation by implanted pacemakers. It can be used with all Vitatron pacemakers as well as with most other types of pacemaker including on-demand types. The new electrode consists of a platinumiridium electrode tip and a helically coiled lead of Elgiloy, insulated by a tube of silicone rubber. A stainless steel stylet can be placed in the lumen of the helical coil for the introduction of the catheter electrode. The tip is fitted with a small barbed silicone ring to prevent dislocation in the critical postoperative period. (PSX 10b, p. 383). To Pacesetter, this Vitatron reference discloses each element of Claim 1 of the ’501 patent (See PSX 8i). This reference discusses an improvement to an endocardial electrode which is designed to reduce dislodgement in the critical postoperative period and which is embodied in the Vitatron MIP 135. The improvement consists of the electrode tip being fitted with “a small barbed silicone ring.” For Pacesetter, the Vitatron improvement is clearly synonymous with the improvement of the ’501 patent. For the Court, however, the Vitatron improvement, as both stated and pictured (See PSX 10b, pp. 382 and 383), is ambiguous. This ambiguity precludes the Vitatron reference from anticipating Claim 1 of the ’501 patent because the Court cannot satisfactorily determine whether each element of Claim 1 is found in the reference. While some elements of Claim 1 are found in the Vitatron reference, such as an endocardial lead (a unipolar intracardiac catheter electrode, type MIP 135), with an electrical conductor (a helically coiled lead of elgiloy), encased in a material inert to body fluids (insulated by a tube of silicone rubber), and an exposed electrically conductive electrode tip (a platinum-iridium electrode tip), not all elements of Claim 1 are clearly found in the reference, particularly nonconducting tine means extending away from the lead body at an acute angle for cooperating with heart tissue to hold the tip in position. Because each element of Claim 1 cannot be found in the Vitatron reference, the Vitatron reference does not anticipate Claim 1 of the ’501 patent. Pacesetter focuses on the phrase “a small barbed silicone ring” as the Vitatron embodiment of the Claim 1 concept. In this phrase, Pacesetter finds each element of Claim 1. But the phrase “a small barbed silicone ring” alone discloses simply three adjectives loosely modifying a solitary noun. Read literally, the phrase describes a ring which is small, which is barbed, and which is silicone. The elements of Claim 1 are not apparent in this phrase. Read in the light of hindsight, however, the phrase gains the allure of being a rather convenient and shorthand description of a tined endocardial lead such as that of Claim 1. This description, according to Pacesetter, must surely anticipate the tined endocardial lead as disclosed in Claim 1. Yet, it is hindsight, as Pacesetter’s evidence on this point illustrates, which informs the phrase “a small barbed silicone ring” and allows one to “read on” the elements of Claim 1 in the Vitatron reference. Hindsight, however, has no place in considering anticipation and without it the Vitatron reference remains ambiguous and incapable of anticipating Claim 1. Perhaps telling of the weakness of the Vitatron reference as an anticipating publication was Medtronic’s introduction of clearer photographs of Vitatron leads which embodied “a small barbed silicone ring.” Because Pacesetter’s witness Dr. Tomlinson was unable to say whether the photograph of Vitatron MIP 135 in the Vitatron reference disclosed a tined endocardial lead (PSX 10b, p. 382), Medtronic sought to introduce a clearer picture as found in a Vitatron MIP 135 sales brochure (PX 208). Although Dr. Tomlinson found the photograph inadequate for purposes of determining whether the lead had tine means or similar projections, the Court finds the photograph sufficient to establish that the Vitatron MIP 135 did not have tine means as disclosed in Claim 1. The Court, in fact, finds the photograph sufficiently clear to establish that the Vitatron MIP 135 was a flange or wedge tip lead. Medtronic also introduced, over Pacesetter’s strenuous objection, other Vitatron sales brochures which used the phrase “a small barbed silicone ring” to describe a flange or wedge tip lead (See, e.g., PX 207). The Court is of the opinion that the phrase “a small barbed silicone ring” as used in connection with Vitatron endocardial leads does not refer to the improvement disclosed in Claim 1 of the ’501 patent. Rather, the phrase “a small barbed silicone ring” as used in the printed publications of 1969 referred to a common flange or wedge tip endocardial lead. Pacesetter also contends that barbed leads fulfilling each element of Claim 1 of the ’501 patent existed in August 1971 before the invention of the tined lead (July 7, 1972) and more than one year before the application for the ’501 patent (June 21, 1973) . According to Pacesetter, Dr. Schulman conceived the idea of a barbed pacemaker lead in 1970 and reduced the barbed lead to practice and publicly used it by August 1971. Pacesetter offered the testimony and related exhibits of Joseph Schulman, James Beazell, Gerald Adomian, Harry Fletcher, Leslie Lettau, Mary Craig, and Albert Rambo to show prior use and prior invention of a barbed or tined endocardial lead. This evidence, however, was largely without the support of contemporaneous and reliable notes, reports, photographs, or other documents, let alone the claimed barbed lead itself. Often the evidence was unclear, obscure, inaccurate, contradictory, inconsistent, and generally wanting of credibility. Nevertheless, Dr. Sehulman and others at Pacesetter believe that they actively researched and experimented with the barbed lead through 1974. This prior invention and public use of a barbed lead, Pacesetter concludes, clearly anticipates Claim 1 of the ’501 patent. Because Pacesetter offered mainly the unsupported oral testimony of witnesses to show prior use and invention, the Court views such testimony with suspicion and subjects it to close scrutiny. E.I. Du Pont de Nemours v. Berkley & Co., Inc., 620 F.2d 1247, 1261 (8th Cir.1980). The Court considers the sufficiency of this testimony in the light of various factors which include: (1) the delay between the event and trial; (2) the interest of the witnesses; (3) contradiction or impeachment; (4) corroboration; (5) the witnesses’ familiarity with details of the alleged prior structure; (6) the improbability of prior use considering state of the art; (7) the impact of the invention on the industry; and (8) the relationship between the witnesses and the alleged prior user. Id. at n. 20. Joseph Sehulman went to work for Standard Scientific Systems, Inc., now Pacesetter Systems, Inc., in April 1969 after receiving his doctorate in biology from the University of California at Los Angeles (UCLA). With the financial backing of A1 Mann, Sehulman rented a small garage facility in Van Nuys, California for Standard Scientific, ordered materials, parts, and testing equipment, and set out to develop a commercially feasible rechargeable pacemaker or pulse generator. The rechargeable pacemaker, not the pacemaker lead, was the primary interest of Sehulman and Pacesetter during Pacesetter’s early years, including 1970-72. All research and experimental efforts were directed primarily to the rechargeable pacemaker. Sehulman believes that he first saw an endocardial lead with silicone rubber tines or barbs when he made a prototype of such a lead in 1970. He described the barbs as being soft and flexible so that when the lead was inserted in the vein the barbs would fold down along the lead body, yet rigid enough that when the lead reached the heart the barbs would pop back out to their original position. In this way, the barbed lead would become entangled with the trabeculae in the ventricle and less likely to dislodge within the first two or three days of implantation. Sehulman contends that he came up with this tined lead design in response to the problem of lead dislodgement. Yet this contention strikes the Court as rather disingenuous because Sehulman testified, contrary to his deposition testimony of November 8-10, 1983, that in 1971 and 1972 he considered dis-lodgement not to be a serious problem. He, in fact, characterized dislodgement to be more like an infection or similar nuisance, but certainly not a serious problem. Nevertheless, Sehulman told of building two different styles of barbed leads prototypes. He described one style of barbed leads as a cloverleaf. The cloverleaf lead had flattened silicone rubber barbs which were petal-like and placed near the electrode tip at either a 90° or 75° angle {See PSX 114(3) and (4); See also PSX 8b). He described another style of lead as having between two and six tubular barbs which were longer and at a sharper angle, maybe 45°, to the lead body {See PSX 114(1) and (2)). Sehulman provided a crude sketch of his barbed lead prototypes (PSX 114). These prototype leads were handmade by cutting the barbs from room temperature silicone rubber with an Exacto knife and gluing them to an existing commercial endocardial lead with silicone adhesive. He remembers the cloverleaf lead as being the better quality handmade lead because the flattened barbs or petals were easier to slice from silicone rubber with a knife. After building the prototype barbed leads, Sehulman tested them in the hearts of living dogs. While Sehulman believes that 20 barbed leads were implanted in dogs in 1971, he cites the dog James as being the first recorded implant of a barbed lead. He remembers implanting a barbed lead in James on August 24,1971 at Harbor General Hospital in Los Angeles with Dr. Criley, the Chief of Cardiology of Harbor General, and James Beazell, the laboratory supervisor. James received a barbed endocardial lead of the cloverleaf variety. Sehulman is able to recall the August 24, 1971 implant date of James because of his personal handwritten record of such dog implants (PSX 48). He recalls that a barbed lead was implanted in James because another personal implant record (PSX 35) shows that the purpose of the James implant was “a new lead design.” “New lead design” meant barbed lead to Sehulman. The Court, however, wonders whether Schulman’s memory and records are perhaps deficient. Neither of these records was prepared contemporaneously with the implant of James. Rather, these records were prepared well after the implant of James. While Sehulman believed PSX 48 to have been prepared on February 5, 1973, it was clearly shown that PSX 48 was prepared sometime much later. Similarly, while Sehulman believed his notation of “new lead design” in the purpose column of PSX 35 to have been made shortly after November 26, 1973, it was shown that the notation to PSX 35 could possibly have been made in 1974. Documents and records related to PSX 48 and 35 were also shown to be flawed with numerous inconsistencies, ambiguities, and contradictions. “New lead design,” which keyed the barb lead to the James implant in Schulman’s mind, was also shown to refer to leads other than barbed leads. For example, Schulman admitted that “new lead design” also referred to a flange lead with a screw-in connector which was being developed at Pacesetter in 1971 and which Schulman sketched for the Court {See PX 206; See also PX 209). In no Pacesetter record is a structure referred to as a “new lead design” clearly shown to be a barbed lead. Supporting documentary evidence, contemporaneous or otherwise, is completely lacking with respect to Schulman’s testimony of a barbed lead implant in James in August 1971. James Beazell offered his oral testimony to corroborate Schulman’s recollection that a barbed lead had been implanted in James in 1971. Beazell, who has a master’s degree in physiology from UCLA, was the supervisor of the cardiology research laboratory at Harbor General Hospital in the early 1970’s when Schulman and Dr. Criley were working on the rechargeable pacemaker. While an employee of Harbor General, Beazell worked closely with Dr. Criley and Schulman in the study and development of the rechargeable pacemaker, especially implants and animal testing. Beazell later became a consultant for Schulman and eventually a full-time employee of Pacesetter. In connection with the pacemaker development, Beazell recalled at least three types of barbed leads. First, he remembered an harpoon- or anchor-shaped barbed lead {See PSX 103(a)). The second type of barbed lead, he recalled, had four or more silicone rubber projections coming off the lead body at an acute angle in a spiral fashion {See PSX 103(b)). The third type of barbed lead, which was developed-much later than the first two barbed leads, was a cloverleaf or umbrella tip lead {See PSX 103(c); See also PSX 8b). Beazell provided a rough sketch of these barbed leads (PSX 103) for the Court. All of these leads had an electrically conductive tip with soft pliant silicone rubber barbs at an acute angle and away from the lead tip. Beazell believed that all three types of these barbed leads had been implanted in dogs in the early 1970’s. He remembered personally implanting the first barbed lead in James in August 1971 at Harbor General Hospital. The implanted barbed lead was handmade and was either harpoon-shaped or spiral-fashion {See PSX 103(a) and (b)). It was not, in direct conflict with Schulman’s recollection, a cloverleaf barbed lead because the cloverleaf lead was not developed and implanted until some years later, possibly 1973 or 1974. Beazell remembered that James was implanted with a barbed lead in August 1971 with reference to one of his implant records {See, e.g., 56, 57 and 58). The implant records had both the implant date for James of August 24, 1971 and the notation “new lead design” which meant barbed lead to Beazell. None of the implant records, however, was contemporaneous with the James implant. Beazell, in fact, had no contemporaneous records of any implant of any barbed lead before June 21, 1973. He admitted that the records for James had been lost and had to be reconstructed. Beazell also admitted that these records were often annotated and information, such as dates, changed. Because Beazell’s testimony lacks sufficient contemporaneous documentation and because it raises conflicts with Sehulman’s testimony, Beazell’s testimony falls short of corroborating Schulman’s testimony with respect to prior use of a barbed lead. Gerald Adomian offered his account of the microscopic analysis of dog hearts with Schulman’s barbed leads to corroborate Schulman’s and Beazell’s testimony about barbed leads in dogs in the early 1970’s. Adomian is a research scientist with a doctorate in biological sciences from UCLA. He specializes in morphology and is expert with both light and electron microscopes. In December 1971, Schulman approached Adomian with respect to evaluating leads implanted within a couple of dog hearts. Schulman was concerned primarily with whether the leads were penetrating the wall of the dog hearts. Adomian states that he is well able to remember the events of 1971-72 for three reasons. First, he was defending his doctoral dissertation in January 1972 and, because of his dissertation defense, Adomian was not immediately able to accommodate Schulman in December 1971. Second, Adomian remembers the events of December 1971 because he believes that, after talking to Schulman and considering the problems and difficulties of implanting a pacemaker lead in the heart, he came up with an “interesting” idea of putting barbs at the end of a pacemaker lead. Third, Adomian remembers December 1971 because it was the first time he had ever seen, let alone analyzed, pacemaker leads in an animal heart. He had no previous experience of any kind with pacing. Adomian examined the two dog hearts from Schulman near the end of January 1972. He recalled that the leads in the dog hearts had a conductive wire covered with a polymer ending at an exposed tip. The leads also had four or five flexible silicone rubber barbs near the tip but pointing away from the tip at a 30° to 45° angle. The barbs were pliant yet rigid enough to maintain the angle to the lead body when unrestrained.' Adomian believed that, in view of the fibrotic process which surrounded portions of the lead tip, that the leads had been implanted in the hearts of living animals for about three months. He did not observe or participate in the lead implants in the living dogs, nor did he see the leads connected to a pulse generator and operating. Unfortunately, Adomian has no written report regarding these barbed leads, no notes of his examination of the dog hearts, no photographs of the leads or the examination, no documents in reference to the leads or the examination, and no tangible evidence of any kind relating to Schulman’s barbed leads or the examination of January 1972. Essentially, Adomian offers the Court completely unsupported oral testimony to corroborate the inadequately supported oral testimony of Schulman and Beazell. Adomian’s testimony, like Beazell’s testimony, fails to corroborate sufficiently Schulman’s testimony with respect to prior use of a barbed lead. Albert Rambo also offered his oral testimony to corroborate Schulman’s account of a prior use of a barbed lead in 1971. Rambo joined Pacesetter in July 1971 as an engineering aide whose duties included electroforming, electroplating, and drafting. He remembered that Schulman conducted several in-house classes for Pacesetter employees in which the various aspects of pacing were discussed. Rambo recalled Schulman talking about a four-barbed lead which was designed to become entangled with the trabeculae. Sometime between July 1971 and May 1972, Rambo remembers, Schulman asked him to photograph a barbed lead. This bipolar lead had a conductor covered with a rubbery material and extending from the lead body and away from the tip at a 45° angle were four barbs of the same rubbery material. The barbs were pliant and flexible. Rambo provided a sketch of the lead which he photographed {See PSX 108). Rambo photographed the lead with a tripod-mounted Polaroid camera with a microscope adapter. He returned the lead with the photographs to Schulman. Rambo thinks Schulman put the photographs in an engineering notebook and does not know what Schulman did with the lead. Rambo also remembers Beazell bringing Schulman a lead still connected to the pulse generator. Schulman had Rambo photograph this lead which differed from the previous lead only in that it was unipolar and had two barbs as opposed to four barbs. Rambo sketched the second lead {See PSX 109). Again, Rambo returned the lead and the photographs to Schulman and, again, Schulman put the photographs into an engineering notebook. Rambo does not know what Schulman did with the lead or pulse generator. Rambo photographed no other pacemaker leads for Schulman while at Pacesetter. Rambo never saw these barbed leads implanted in a dog or human heart. He, in fact, does not know if these leads were ever used. While Rambo is certain that Schulman put the photographs of the leads into a blue spiral binder engineering notebook, he does not know where that notebook is today and it was not produced at trial. Rambo’s testimony comes closest to corroborating Schulman’s testimony. Yet Rambo’s oral testimony remains unsupported and has failed to convince the Court that Schulman was responsible for a prior use or invention of a barbed lead in 1971. Pacesetter, in addition to the oral testimony of its witnesses, offered what it considered to be tangible evidence of barbed or tined leads existing before the conception of a tined lead as illustrated in the '501 patent. Pacesetter introduced a single cavity barbed lead mold (PSX 9a) which Les Lettau made at the direction of Harry Fletcher in the Spring of 1972. Pacesetter also introduced the testimony of Schulman, Fletcher, Lettau, Rambo, and Craig to establish the existence and use of a barbed lead mold in 1972. But the testimony with respect to the barbed lead mold, like the testimony with respect to Schulman’s conception, construction, and implantation of the barbed lead, is unclear and inconsistent. Harry Fletcher came to Pacesetter in March 1971 as an engineer of sorts. Fletcher’s main job in March 1971 was to develop a lead winding machine, but he also remembers working with Schulman on the development of the lead body. Fletcher recalled that at this time Schulman had spoken to him of developing a lead that would not slip inside the heart of a dog. Schulman designed such a lead styled as a barbed lead for which Fletcher made an aluminum mold. From this mold, Fletcher believes, a couple of dozen prototype barbed leads were made. The lead was coiled wire in a silicone rubber insulation ending in an electrically conductive tip. Extending from the lead body and away from the lead tip at an angle of 30° were soft, pliant silicone rubber barbs. Fletcher sketched this barbed lead (PSX 94). Fletcher also recalled that about 15 barbed leads were made in 1971 at an outside molding company with a transfer mold because Pacesetter did not have transfer molding equipment at that time. He believes that all these leads were implanted in dogs, but he himself witnessed only one implant with Schulman and Beazell in late Summer or early Fall 1971. Fletcher recalled that in February 1972 Les Lettau came to Pacesetter to do machine work, including making molds. In early 1972, at Fletcher’s direction, Lettau made a single cavity barbed lead steel mold (PSX 9a). From this mold were produced two-barbed leads which were similar to PSX 8a. The leads produced had a silicone rubber body ending in an electrically conductive tip. Coming off the lead body at an acute angle were silicone rubber barbs which appeared to hold their shape when unrestrained. Fletcher first saw the single cavity steel mold (PSX 9a), which Lettau made, in March 1972. At that time, the mold, which Fletcher sketched (PX 163), was a transfer mold with two sprues (B and C) and two gates (D and F) serving the main channel or cavity of the mold. Three or four days after receiving this mold from Lettau and before ever using the mold, Fletcher ordered that it be modified. Two more gates (green lines) were added. Because Fletcher could not find an outside firm to do the transfer molding and because Pacesetter did not then have the facilities to do transfer molding, Fletcher had Lettau convert the mold into a compression mold. To convert the mold to a compression mold, the channel or cavity of the mold was extended the length of the mold, the sprues (B and C) and the gates (D and F) were plugged, and the two remaining gates were enlarged to form a barb. Basically, the mold evolved from these two configurations of a transfer mold and compression mold. After the mold was completed sometime in 1972, Fletcher made a few leads with it. He would take an available commercial lead and center it in the mold so that the ring electrode of the lead rested in the little widening or groove just behind the plugged sprues. He then would put a silicone compound in the cavity, close the mold, and heat it up. Fletcher believes he made leads in this manner and similarly instructed others at Pacesetter. He never observed any of these leads being implanted, nor did he see any test results of these leads. Fletcher, in fact, has no knowledge of whether these leads were ever implanted in a dog. Leslie Lettau went to work for Pacesetter in February 1972 as a machinist. His first project at Pacesetter was to build an aluminum mold. He built a single cavity four-barbed lead aluminum mold. Lettau’s next project was to build a single cavity two-barbed steel mold (PSX 9a). He remembers this mold because he began the mold at the Pacesetter facility on Keswick in Van Nuys and completed it at the new Pacesetter facility in Sylmar in mid-May 1972. This mold, he assumed, was used to produce a two-barbed lead much the same as PSX 8a, but he never actually made a lead with the mold, nor did he see anyone else make a lead with the mold. When Lettau first made the mold at the Van Nuys facility, it was a compression mold with a single main channel and two small channels to form barbs {See PX 199; See also PSX 111(1) and 113). The mold was tried in that form and then he was ordered to convert it to a transfer mold. To convert the mold to a transfer mold, he drilled two sprues (A), two gates (B), and two barb cavities (C) {See PX 200; See also PSX 111(2) and 113). Lettau gave the transfer mold to Fletcher who soon returned it to Lettau to be reconverted to a compression mold. To reconvert the mold to a compression mold, Lettau effectively had to reorient the mold. He plugged the two sprues (black), filled in the gates and barb channels (green), cut two new barb channels (C), widened the area for the ring electrode placement (A), and drilled three vent holes (1, 2, 3) in the main cavity {See 201; See also PSX 111(3) and 113). For Lettau, the two-barbed lead steel mold evolved from three configurations. Mary Craig began working for Pacesetter in January 1973 as a lead person. As a lead person, Craig instructed other employees how to build the mechanical part of the lead. She remembers from January 1973 a number of leads, including a two-barbed lead. The barbed lead had a coil conductor encased in silicone rubber ending in a metal tip assembly. The silicone rubber barbs extended from the lead body away from the tip at approximately a 30° to 45° angle. Craig did not see the two-barbed lead mold (PSX 9a) until June 1973 when she was promoted to supervisor of the leads department. During the Summer of 1973, the two-barbed lead mold was used under her supervision to produce barbed leads. Craig believed that in this time approximately 100 barbed leads were made. At the end of the Summer of 1973, she gave the mold to the engineering department. Craig did not see the mold again until she was asked to make a barbed lead (PSX 8a) for the purposes of this litigation in November 1983 and January 1985. In using the two-barbed lead in the Summer of 1973, just as in November 1983 and January 1985, Craig stated that the technician filled the main cavity of the compression mold halves with silicone rubber and placed the existing commercial lead into the cavity. The commercial lead, however, was positioned with the ring-tip electrode in the relief area rather than the main cavity. The mold was then closed and pressed. After removing the mold, the lead was taken from the cavity and the excess silicone rubber or flash was trimmed. The lead was cured in the curing oven and then was ready for finishing touches (See PSX 9d(l) and 9d(2)). Albert Rambo also remembered leads being made in this manner from mid-1972 to mid-1973. The testimony of Fletcher, Lettau, and Craig may establish the existence of a single cavity mold (PSX 9a) at Pacesetter in 1972-73, but their testimony raises more questions than answers with respect to how the mold came to be through its various configurations, how the mold was used in production, and what types of leads were produced from the mold. For example, both Fletcher and Lettau identified the single-cavity mold (PSX 9a) as the final configuration of the mold which they, under the direction of Schulman, designed and built in early 1972. But Fletcher and Let-tau do not remember the mold evolving from the various configurations in the same way. Fletcher recalls the mold going through only two configurations, the transfer mold and the compression mold. Yet Lettau specifically recalls the mold going through three configurations, the compression mold, the transfer mold, and the reoriented compression mold. The two men most actively associated with the development of this rather important single cavity mold cannot agree on how the mold came to be in its final form. Their disagreement is curious because they both emphasized the clarity of their recollection at trial of the events relating to the development of the mold. Craig also identified the single-cavity mold (PSX 9a) as the final configuration of the mold which she used to make barbed leads in 1973. But Craig used the mold in a manner different from that which Fletcher and Lettau described as its intended manner of use. Craig told of positioning the commercially available lead body in the mold so that the ring-tip electrode rested in the relief area just at the end of the main cavity of the mold. Both Fletcher and Let-tau, on the other hand, said that the ring-tip electrode of the lead was intended to rest in a small specially grooved area of the main cavity of the mold. Craig, Fletcher, and Lettau were each clear in their own way on where the lead body was to be positioned and how the mold was to be used. That Craig’s use of the mold differed from that which Fletcher and Lettau, the designers and builders of the mold, intended is interesting because it suggests that the use of the mold and its resulting product are not necessarily limited by the apparent or intended design of the mold. Rather, the user of the mold has some play to fashion a lead in a desired configuration even though the mold design might not readily lend itself to the lead configuration that the user desires. The testimony of and exhibits related to Fletcher, Lettau, and Craig also raise questions with respect to exactly what types of leads could have been produced from the mold and what types of leads were actually produced from the mold. A source of these questions was a three-cavity wedge tip lead mold of Pacesetter (PX 165). Let-tau stated at trial, contrary to his deposition testimony of January 4, 1985, that he was sure he made this three-cavity mold in July and August 1972. Lettau now remembers that he built the three cavity mold (MX 165) shortly after the single-cavity mold (PSX 9a) in May 1972. Lettau also remembers that the three-cavity mold was used exclusively to make wedge tip leads, not barbed leads. Fletcher and Craig confirmed that the three-cavity mold was used to make wedge tip leads. Comparing the single-cavity mold to the three-cavity mold, the Court finds that the molds are not dissimilar. The molds, in fact, share a number of features common to a transfer mold, including similarly located sprues, gates, and injection holes in the main channel or cavity. The most noticeable difference between the two molds, other than the plugged sprues and gates in the single-cavity mold, is the tip configuration. The tip of the lead in the single-cavity mold was straight shanked and the tip of the lead in the three-cavity mold was wedged. The similarities between the two molds point to the not so unreasonable possibility that the single-cavity mold was once intended and crudely built to produce straight shank leads through the transfer mold process. The three-cavity mold which followed shortly was a more refined attempt at the transfer mold process intended and built to produce wedge tip leads. The Court is not convinced that the single-cavity mold (PSX 9a) was expressly intended, designed, constructed, and used to produce Schulman's two-barbed lead. In reaching this conclusion, the Court does not ignore Fletcher’s testimony that the single-cavity mold was intended to produce two-barbed leads, or Craig’s testimony that she observed and personally used the single-cavity mold to produce two-barbed leads. Rather, the Court notes, as Craig’s testimony illustrates, that a mold can be used in various ways to arrive at a desired lead configuration. Just