Citations
- 315 F. Supp. 2d 552
Full opinion text
MEMORANDUM OPINION
THYNGE, United States Magistrate Judge.
I. INTRODUCTION
In July 2002, this court issued a claim construction opinion following a Markman hearing held in May 2002. In November 2002, a trial was held on the patent infringement dispute between Genzyme and Atrium regarding pulmonary drainage devices. Genzyme alleged damages caused by the marketing and sale of Atrium’s “OASIS” and “EXPRESS” devices, which allegedly infringed Genzyme’s “Elliot patents” (U.S. Patent Nos. 4,544,370; 4,715,-856; 4,747,844 and 4,822,346) and its “D’Antonio patent” (U.S. Patent No. 4,899,531). Both parties reserved the right after the verdict for the court to decide certain issues of law and fact. After the eight day trial, the jury found that Atrium did not infringe any claims of the patents-in-suit and that claims in issue in the ’531 and ’844 patents were invalid.
II. PROCEDURAL AND FACTUAL BACKGROUND
The technical overview and procedural history that follows is drawn from the trial record, the court’s claim construction, the evidence presented to the jury and the patents themselves. These sections address factual findings and procedural issues associated with each of the patents individually, and discuss the specific issues raised in the post trial motions before the court.
A. The D’Antonio Patent
Technology and Claims
The D’Antonio patent is directed toward a medical device used during surgical procedures to clear fluids and air from the body cavity. Chest drainage devices that used water columns as one-way valves to prevent the flow of fluid back into the patient also act to regulate the suction applied to the patient by preferentially allowing air from the atmosphere into the suction and collection chambers. Medical personnel would regulate the suction by varying the amount of water in U-shaped tubes within the device. Instead of employing a water-based control mechanism, the D’Antonio patent utilizes a mechanical valve that “preferentially applies suction pressure” to regulate the pressure between the chambers. This is accomplished, in part, by a gas port closing member positioned between the vacuum and collection chambers within the device.
The specific D’Antonio patent claims in dispute at trial were 1, 16, 17 and 18 of the ’531 patent. These claims provide for a “closing means” that functions to regulate the pressure between two chambers in the device.
The ’531 patent recites:
A system for draining fluids from a portion of the body comprising an inlet port, a suction chamber, a suction regulator consisting of two chambers (one connected to suction and the other to the atmosphere) with an opening and a closing means between the chambers, and a biasing means for adjusting the position of the closing means in order to regulate the pressure between the chambers (claim 1). It also claims a system similar to that in claim one where the closing means can be set to a predetermined position by applying a force to the closing means and that force dampened by a dampening means (claim 16). The dampening means is described as a dash pot (claim 17). The closing force applied in claim 16 to the closing means is determined by a biasing means (claim 18).
Procedural History
As a result of the Markman hearing and opinion, claim language in the ’531 patent was defined and subsequently included in the instructions to the jury. Relevant to the arguments before the court, a suction regulator “closing means” was defined as a mean-plus-function element of the claim. The functions set forth were opening and closing and the corresponding structure was “a ball that is disposed within the opening in the dividing means, or a hinged door, and structural equivalents thereof.” This definition was consistent with the construction that Genzyme proposed and was not subsequently disputed by Genzyme prior to or during the course of the trial, or as included in the jury instructions.
Throughout this case, including at trial, Genzyme contended that Atrium’s manufacture, use, offer for sale, and/or sale of its EXPRESS and OASIS chest drainage devices infringed claims of the D’Antonio patent. Before trial, Atrium pursued a motion for summary judgment for non-infringement of the D’Antonio patent, contending that its accused devices did not contain the disclosed “spherical ball” limitation defined by the “closing means” as specified in the patent. The court ruled in favor of Genzyme holding that the structural equivalence of “a ball disposed within the opening in the dividing means or a hinged door” was a disputed issue of material fact. Concomitantly, the issue of structural equivalents was the thrust of the dispute between the parties.
At trial, expert testimony distinguished Genzyme’s device from the prior art and established its functional equivalence to Atrium’s device. Testimony was also offered suggesting that a ball and flat plate were interchangeable structures. In addition, testimony revealed that other structures were present in the Atrium devices that had equivalent functions to the “closing means” described in the D’Antonio patent. Finally, expert testimony explained how the Atrium devices potentially infringed.
In contrast, testimony for the defense revealed that a weighted ball is not equivalent to a flat disk. Other evidence showed that Atrium invested in the research and development of its suction regulator and found that the use of a “ball” in its design was not commercially available nor economically feasible at the time. Under cross examination, Genzyme’s witnesses testified that Deknatel (a predecessor company of Genzyme) did not, nor did any commercial chest drainage device, use a ball within an opening or a hinged door as a suction regulator closing means. The prosecution history revealed that in distinguishing the ’531 patent from Willwrath et al., D’Antonio argued that Willwrath’s spherical element was not disposed within the opening, and he claimed that his “closing means was responsive to slight variations in pressure on the opposite sides thereof ... providing a preferential draw from the patient.” This feature also distinguished his claims from the Akiyama. However, Dr. D’Antonio testified on cross-examination that a ball within an opening is equivalent to a flat plate because “one could cut the top and bottom off the ball.”
B. The Elliot Patents
Technology and Claims
These patents disclose devices that remove fluid and air from a patient’s chest cavity through the use of vacuum suction. Body fluids are drained through a tube into a collection chamber within the device. Proper operation requires the use of one-way “valves” to prevent the reverse flow of collected fluids due to negative inhalation pressure. Prior art devices used a water column to act as a one-way valve or “water seal” to prevent reverse flow. The Elliot patents disclose a “waterless” or “dry” device that replaces water seals with a mechanical one-way valve. The patents further disclose a number of pressure relief and control valves to allow for accurate pressure regulation and reverse flow protection.
The Elliot patent claims in dispute were claims 1 and 6 of the ’370 patent; claims 5, 6, 12, 13, 16 and 21 of the ’844 patent; claims 5 and 11 of the ’346 patent; and claims 2, 3, and 4 of the ’856 patent. These claims primarily disclose structures within a device that provide for waterless operation and leak detection.
The ’370 patent recites:
A non-water seal thoracic drainage system comprising: a collection bottle, a fluid chamber, a one-way waterless valve in the flow path from the chamber to the outlet, which is the sole means to prevent reverse flow, unaided by water-based seals and a U-tube leak detector (claim 1). The patent further claims an air chamber in the device that is large enough to dampen leak detector fluctuations in response to positive pressure surges (claim 6).
The ’844 patent recites:
A non-water seal thoracic drainage apparatus comprising a negative pressure relief valve vented to the atmosphere (claims 5 and 6). It claims inlet and outlet tubes to a collection chamber that contains a one-way waterless valve means along the flow path between the inlet and outlet tubes (claim 12), and includes a high negative pressure relief valve, connected to a source of increased pressure or the atmosphere (claim 13) and designed to open when the pressure in the flow path exceeds a predetermined value. In addition, it claims a positive pressure relief valve to vent to the atmosphere (claim 16) and also claims the apparatus in claims 17-20 with a fluid filled air leak detector and high negative pressure relief valve (claim 21).
The ’346 patent recites:
A non-water seal thoracic drainage apparatus containing a high negative pressure relief valve which opens at a predetermined value and is connected to a source of high pressure (claims 5 and 11).
The ’856 patent (a continuation of the ’370 patent) recites:
An apparatus according to claim 1 (a device for draining a patient’s chest cavity) which includes a flow control valve connectable to a source of external suction which can control the suction to the upstream one-way valve seal (claim 2). It also claims the apparatus in claim 2 containing a positive pressure relief valve (claim 3) and a high negative suction relief valve (claim 4).
Procedural History
As noted previously, several terms in the Elliot patents were defined for the jury as a result of the Markman hearing. A “one-way” and “one-way waterless valve means” was defined as a “type of valve, also known as a check valve, that allows the flow of fluid in one direction but prevents flow in the reverse direction.” In addition, a “water seal” was defined as “a fluid filled structure that allows air to escape from a patient, but prevents back flow of air to the patient.” Finally, an “air leak detector” or “U-tube” was defined as an “air leak detector or U-tube that does not act as a water or fluid seal.” Similar to the D’Antonio claims, these definitions were consistent with the constructions Genzyme proposed throughout litigation, and were not subsequently disputed by Genzyme prior to or during the trial, including in the jury instructions.
At trial, Genzyme contended that Atrium’s manufacture, use, offer for sale, and/or sale of its EXPRESS chest drainage device infringed claims of the Elliot patents. The focus of the alleged infringement centered on Atrium’s one-way waterless valve and “U-tube” air leak detector. These structures were specified in patents ’370, ’346, ’856 and ’844. Expert testimony was presented to demonstrate how Atrium’s EXPRESS device met the claim limitations by including both structures. Evidence was also presented that air leak detectors could optionally be filled with fluid or left empty during normal operating conditions. Testimony also revealed that when the one-way valve in the EXPRESS device was working properly, under normal operating conditions, its fluid filled air leak detector could not act as a water seal.
Evidence, including test results and expert testimony, demonstrated that Atrium’s EXPRESS device, modified to simulate the failure of a one-way valve, would allow the U-tube air leak detector to function as a water seal and prevent reverse flow to the patient. In addition, the air leak detector could not act as a water “safety” seal, nor could it act as a “seal” or an air leak detector when it was not fluid filled.
Further, testimony was presented that the Elliot patents exclude a water seal and that a water seal is present in the EXPRESS model as a structure carried over from previous designs.
Moreover, the evidence showed that Dr. Elliot distinguished his invention from the prior art, which contained either mechanical or water seals, by explicitly requiring a “one-way waterless” valve means unaided by water seals. Finally, expert testimony was presented that a “one-way waterless valve means” requires that a mechanical check valve (a waterless valve) is the sole means for preventing reverse flow to a patient. At the conclusion of the evidence, Genzyme moved pursuant to Fed.R.Civ.P. 50(a) for judgment as a matter of law (JMOL) that Atrium infringed the claims of the D’Antonio and Elliot patents in question. That motion was denied and the issue of infringement was decided by the jury-
III. STANDARD OF REVIEW
A. Motion For Judgment As A Matter Of Law
Genzyme requests judgment as a matter of law to reverse the jury’s finding of non-infringement of the Elliot and D’Antonio patents, or in the alternative, seeks a new trial on infringement. In moving for JMOL, Genzyme seeks relief from an adverse jury verdict. To prevail on a renewed motion for JMOL following a jury trial, a party “must show that the jury’s findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) implied [by] the jury’s verdict cannot in law be supported by those findings.” Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed. Cir.1998), quoting Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed.Cir.1984), accord LifeScan, Inc. v. Home Diagnostics, Inc., 103 F.Supp.2d 345, 350 (D.Del.2000).
The inappropriateness of entering judgment as a matter of law “solely” on the basis of inconsistent verdicts is evident in the procedural requirements under Fed. R.Civ.P. 50(b), which requires a motion prior to the return of the verdict. See Mosley v. Wilson, 102 F.3d 85, 90 (3d Cir.1996). In addition, Fed.R.Civ.P. 49(b) instructs courts facing a jury’s inconsistent answers to special interrogatories to either return the question to the jury or to order a new trial. Id. On this point, Mosley references the dissenting opinion of Justice Stevens in Los Angeles v. Heller, 475 U.S. 796, 804-06, 106 S.Ct. 1571, 89 L.Ed.2d 806 (1986). Justice Stevens commented that the court has the option to let the verdict stand, attempt to read the verdict in a manner that will resolve inconsistencies, resubmit the question to the jury, or order a new trial where the evidence might support either of the “inconsistent” verdicts. Mosley, 102 F.3d at 90.
Substantial Evidence
The substantial evidence standard is established “if that minimum quantum of evidence” from which a jury might reasonably afford relief exists to support the jury’s verdict. In that circumstance “a motion for JMOL must be denied.” Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229, 59 S.Ct. 206, 83 L.Ed. 126 (1938) (“Substantial evidence is more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion”). In contrast, JMOL was granted where “reasonable jurors” could not have found otherwise because “the record before the jury contained no evidence to rebut the substantial evidence of infringement.” LNP Eng’g Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347, 1353, 1357 (Fed.Cir.2001). (emphasis added). In assessing the sufficiency of the evidence, the court must give the non-moving party the benefit of the doubt, resolve all conflicts in the evidence in his favor, and in general, view the record in the light most favorable to him. LifeScan, 103 F.Supp.2d at 350. A court may not substitute its view of the evidence for the jury’s view. Rather, the court must determine whether the evidence reasonably supports the jury’s verdict. See Dawn Equip. Co. v. Kentucky Farms, Inc., 140 F.3d 1009, 1014 (Fed.Cir.1998).
The Federal Rules of Evidence (FRE) require that the evidence presented be relevant to the matter in dispute and free from unfair prejudice. According to FRE 401-403, admissible evidence must be relevant, or tend to make a fact more or less probable. The trial judge is obligated to act as a “gatekeeper” and has broad discretion to balance the probative value of the evidence against its potential prejudicial harm. See Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 961 (Fed.Cir.1997). Further, error in the admission of evidence is not grounds for granting JMOL or a new trial, if its admission was harmless error. Fed.R.Civ.P. 61. The factors guiding the courts in determining harmless error are well documented. Statements made about prior art and infringement in closings that accurately reflected evidence, which has been admitted without objection, are not improper. See Loral Fairchild Corp. v. Victor Co. of Japan, Ltd., et al., 208 F.Supp.2d 344, 360 (E.D.N.Y.2002). Ultimately, it is within the trial court’s discretion to exclude evidence when the “probative value is outweighed by the danger of unfair prejudice, confusion of the issues or misleading the jury.” Fed. R.Evid. 401 and 403.
B. Motion For A New Trial
Federal Rule of Civil Procedure 59(a) provides that a “new trial may be granted ... for any of the reasons for which new trials have heretofore been granted in actions at law in the courts of the United States.” Fed.R.Civ.P. 59(a). New trials should be granted “when the record shows that the jury’s verdict resulted in a miscarriage of justice or where the verdict, on the record, cries out to be overturned or shocks our conscience.” Applera Corp. MDS., Inc. v. Micromass UK Ltd., 204 F.Supp.2d 724 (D.Del.2002) quoting Williamson v. Consol. Rail Corp., 926 F.2d 1344, 1353 (3d Cir.1991). However, the decision to grant or deny a new trial is “committed to the sound discretion of the district court.” Allied Chemical Corp. v. Daiflon, Inc., 449 U.S. 33, 36, 101 S.Ct. 188, 66 L.Ed.2d 193 (1980). Although the Federal Circuit has reviewed whether irrelevant and prejudicial evidence was presented at trial, this issue is not unique to patent law and Third Circuit law applies. See Union Carbide v. Shell, 308 F.3d 1167 (F.Cir.2002).
“Among the most common reasons for granting a new trial are the following: (1) the jury’s verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice; (2) newly discovered evidence exists that would likely alter the outcome of the trial; (3) improper conduct by an attorney or the court unfairly influenced the verdict; or (4) the jury’s verdict was facially inconsistent.” Lucent Techs., Inc. v. Newbridge Networks Corp., 168 F.Supp.2d 181 (D.Del.2001). In determining whether to grant a motion for a new trial, the court “need not view the evidence in the light most favorable to the verdict winner.” Id. at 251. Similar to a motion for JMOL, a court cannot grant a new trial “merely because the court would have weighed the evidence differently and reached a different conclusion.” Id. citing Markovich v. Bell Helicopter Textron, Inc., 805 F.Supp. 1231, 1235 (E.D.Pa.), aff'd, 977 F.2d 568 (3d Cir.1992). On a motion for a new trial where a party contends that the jury’s verdict was against the weight of the evidence, a new trial should “be granted to prevent a miscarriage of justice,” but a court should “proceed cautiously” since such a decision would necessarily substitute the court’s judgment for that of the jury. MLMC, Ltd. v. Airtouch Communications, Inc., 215 F.Supp.2d 464, 470 (D.Del.2002); Klein v. Hollings 992 F.2d 1285, 1290 (3d Cir.1993).
IV. GENZYME’S MOTION FOR JMOL THAT THE D’ANTONIO ’531 PATENT AND ELLIOT ’844 PATENT ARE VALID
A. Legal Standard
Anticipation
Patents are evaluated under a statutory presumption of validity. See 35 U.S.C. § 282. Nonetheless, patent claims may be invalidated when it is proven that a prior art reference “anticipates” the invention. Applied Medical Resources Corp. v. U.S. Surgical Corp., 147 F.3d 1374, 1378 (Fed.Cir.1998). A patent is anticipated by prior art and invalid if the invention was “described in a printed publication in this or a foreign country ... more than one year prior to the date of the application for patent in the United States.” 35 U.S.C. § 102(b). Determinating anticipation is a two step process of construing the claim and comparing the claim to prior art. The latter is a matter of fact for the jury and includes determining what a reference teaches by clear and convincing evidence. In Re Baird, 16 F.3d 380 (Fed.Cir.1994). Evidence offered to defeat the presumption of validity must always be clear and convincing. Ryco, Inc., v. Ag-Bag Corp., 857 F.2d 1418 (Fed.Cir.1988) (a patent is presumed valid, and the party attacking validity has the burden of proving facts supporting a conclusion of invalidity by clear and convincing evidence). Ultimately, the teachings of the prior art must place the invention claimed in possession of the public. W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540 (Fed. Cir.1983).
For a patent to be anticipated, every element of a patent claim must appear in a single reference. Other references and opinion may be used to reveal what the reference would have meant to those skilled in the art at the time of the invention. Studiengesellschaft Kohle, m.b.H. v. Dart Indus., Inc., 726 F.2d 724, 727 (Fed.Cir.1984). A trier of fact must identify the claimed elements, determine their meaning in light of the specification and prosecution history and identify those same elements in the anticipating reference. It is error to treat the claims as a mere catalog of parts, disregarding the part-to-part relationships set forth that give the claims their meaning. Lindemann Maschinenfabrik v. American Hoist & Derrick Co., 730 F.2d 1452 (Fed.Cir.1984). Experts often use the same words to describe the same device and a prior art reference. However, whether the terms are being used in different ways to connote different intended functions is the issue. The “prior art cannot anticipate a patent simply by possessing identically named parts, unless these parts also have the same structure or otherwise satisfy the claim limitations, and were understood to function in the same way by one skilled in the art.” Applied Med. Res. Corp., 147 F.3d at 1380. (emphasis added).
For a prior art reference to anticipate a claim, the reference must disclose each and every element of the claim with sufficient clarity to prove its existence in the prior art. Presumed knowledge of one skilled in the art does not allow an expert to read into the reference elements that are not there. See Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1473 (Fed.Cir.1997). An expert’s “conclusory testimony, unsupported by documentary evidence, cannot supplant the requirement for anticipatory disclosure in the prior art reference itself.” Id. Where no reasonable jury could find that the defendant has met its burden establishing that each and every limitation of the claim has been disclosed, the Federal Circuit will uphold a district court’s finding of validity on a motion for JMOL. Structural Rubber Prods. v. Park Rubber Co., 749 F.2d 707, 715 (Fed.Cir.1984).
Obviousness
“Invalidity based on obviousness is a question of law based on the underlying facts. The relevant facts relate to (1) the scope and content of the prior art, (2) the level of ordinary skill in the field of the invention, (3) the differences between the claimed invention and the prior art, and (4) any objective evidence of nonobviousness, such as, long felt need, commercial success, the failure of others, or copying.” C.R. Bard, Inc., v. M3 Systems, Inc., 157 F.3d 1340, 1351(Fed.Cir.1998), quoting Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). The subject matter of the claim constitutes what is “sought to be patented” and that is, therefore, the sole object of the court’s concern in determining obviousness. In re Sovish, 769 F.2d 738 (Fed.Cir.1985).
Where there is a new combination or arrangement of mechanical components, a conclusion of obviousness requires that there be “some suggestion, motivation, or teaching in the prior art whereby the person of ordinary skill would have selected the components that the inventor selected and used them to make the new device.” Id. Similar to the analysis under anticipation, there is a presumption of validity, and a “party seeking a judgment that a patent is obvious bears the burden of demonstrating by clear and convincing evidence that the teachings of the prior art would have suggested the claimed subject matter to one of ordinary skill in the art.” Union Carbide v. Shell Oil, 308 F.3d 1167, 1186 (Fed.Cir.2002). Concomitantly, substantial evidence must support the factual findings necessary to support that legal conclusion. Bard, 157 F.3d at 1362.
A single prior art reference may be used to render a claim obvious, but there must be a suggestion or motivation to modify its teachings to the claimed invention based on the reference itself, the knowledge of one of ordinary skill in the art, or from the nature of the problem to be solved to support the obviousness conclusion. SIBIA Neurosciences Inc. v. Cadus Pharm. Corp., 225 F.3d 1349 (Fed. Cir.2000). In contrast “where a reference discloses the exact element at issue and discloses the motivation for using the element to improve the properties of the invention,” obviousness in light of that reference alone is clear. In re Inland Steel Co., 265 F.3d 1354, 1361 (Fed.Cir.2001). (emphasis added).
In determining whether the clear and convincing evidence standard is met, the court must consider secondary factors of nonobviousness. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed.Cir.1983). While not conclusive, secondary factors of nonobviousness are an important part of the determination and must be given appropriate weight in the analysis. Factors, such as, commercial success, filling an unmet need, competitive copying, and licensing can contribute to that determination. Conclusory statements of success, for instance, are generally not enough. A nexus must exist between the invention and the commercial activity. That burden, through evidence of, such as, market share, growth of market share and replacement of earlier sales by others, must be met by the patentee and weighed against the challenger’s rebuttal. Kansas Jack, Inc. v. Kuhn, 719 F.2d 1144 (Fed. Cir.1983)
B. Validity of the ’531 Patent Claims
The Zuhdi-Kimmel Reference
Claims 1, 16, 17 and 18 of the ’531 were found to be both invalid as anticipated and obvious by the Zuhdi-Kimmel regulator. The Zuhdi-Kimmel regulator is described as a device that is approximately 13 cm in height, having a central knob to adjust vacuum pressure. The knob is connected to a spring and a seat disc that reacts to vacuum, which, in turn, modifies the influx of air to control the amount of vacuum in the line connected to a collection vessel. The figures in the reference show the regulator connected via a “T-type” tubing junction to a source of vacuum and to either a collection or return reservoir.
As an expert for the defense, Dr. Kamm testified that Atrium’s “closing means” was similar to the “closing means” in the Zuh-di-Kimmel regulator, but “quite different” from the ball in the D’Antonio patent. In reference to the closing means, he stated that if the D’Antonio and Zuhdi-Kimmel regulators were the same, then the D’Antonio claims are invalid.
Testifying for Genzyme, Dr. McDonald believed that Messrs. Hochberg and D’Antonio represented during the prosecution of the patent that the Zuhdi-Kimmel regulator appeared to be different. However, he was uncertain whether such representation was necessary for the issuance of the patent. Dr. McDonald testified that there were features in D’Antonio’s invention that were not in Zuhdi-Kimmel, specifically a unitary system configuration and a suction chamber. He also testified that the closing means in the Zuhdi-Kimmel regulator was structurally equivalent to the closing means in the D’Antonio patent.
D’Antonio also testified that there was no suction chamber in the Zuhdi reference. He stated that tubes could not operate as a suction chamber because a certain volume is required for the chamber to function properly, and tubes do not satisfy that requirement. Further, his testing indicated that sufficient chamber volume is needed to equilibrate the two flows; otherwise, the device would be inoperable.
Discussion
Anticipation of the ’531 patent by the Zuhdi-Kimmel Reference
The Zuhdi-Kimmel reference does not anticipate claims 1, 16, 17 and 18 of the ’531 patent. At trial, Atrium did not present clear and convincing evidence that this reference had each and every component of the ’531 patent claims. Specifically, substantial evidence was not proffered that the Zuhdi-Kimmel reference contains a suction chamber. For a finding of invalidity, Atrium bears the burden to support such a conclusion by clear and convincing evidence. Atrium relies primarily on a single statement — Dr. McDonald’s answer to a hypothetical question on cross examination — as its proof of invalidity. This response alone does not meet the standard required to render claims 1, 16, 17 and 18 invalid.
In addition, Atrium’s post trial argument that a “T” tubing junction meets the court’s definition of a vacuum chamber is without merit. No adequate evidence substantiating this argument was presented.
Substantial secondary indicia of validity shows that Genzyme was successful at increasing market growth and licensing products based on this technology. As a result, the Zuhdi-Kimmel reference does not anticipate and render the claims of the ’531 patent invalid.
In response to Genzyme’s post trial motion, Atrium argues that “expert opinion on ‘the ultimate issue of infringement’ even without detailed explanation created a prima facie showing that the fact finder was free to accept or reject.” Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1574-76 (Fed.Cir.1991). (emphasis added). However, meeting the clear and convincing standard is still required for invalidity. In Symbol Techs, there was competent evidence to uphold the trial court’s finding of patent validity. There, expert testimony of a co-inventor was sufficient when supported by the charts and drawings used by that inventor to demonstrate and explain infringement of means-plus-function claims. Id. at 1574. Unlike Dr. McDonald’s answer, the charts in Symbol Techs showed and described each asserted claim and the corresponding structural parts of the accused devices depicted in the drawings. Testimony described how each claim limitation was met by the corresponding structure of the device in the drawings. In addition, the co-inventor explained the bases for his conclusion. Id.
The thorough Symbol Techs point-to-point examination of the Zuhdi-Kimmel article, and how it meets each of the claims of the D’Antonio patent, did not occur at trial. Specifically absent from the analysis was reference to the suction chamber element in the ’531 patent. Rather than proving that the Zuhdi-Kimmel device satisfied this claim element, Atrium focused on comparing its regulator with the closing means in the D’Antonio device. In contrast, witnesses for Genzyme explained how tubing in the Zuhdi-Kimmel reference could not possibly function as a suction chamber. Further, those witnesses testified that the Zuhdi-Kimmel reference would not invalidate the D’Antonio patent due to a number of differences, including the lack of a suction chamber. No directly contrary evidence was presented by Atrium. Similar to the finding that Opticon failed to prove invalidity by clear and convincing evidence in Symbol Techs., Atrium has failed to do the same here.
Obviousness of the ’531 Patent by the Zuhdi-Kimmel Reference
The Zuhdi-Kimmel reference does not render the ’531 patent claims obvious since there is no evidence that this reference alone is enough to motivate, suggest or teach the combination of the elements in the D’Antonio patent. Atrium argues that the burden of clear and convincing evidence of obviousness was implicitly met since there were suggestions to combine a suction chamber and regulator in several prior art references other than Zuhdi-Kimmel. In adherence to the special verdict form, the jury’s determination required a finding based on a single reference. Therefore, a reasonable jury could not have found that the D’Antonio claims were obvious in light of the Zuhdi-Kimmel reference alone, since the reference lacks the element of a suction chamber.
According to Atrium, sufficient evidence exists to sustain a verdict of obviousness because the motivation or teaching implicit in the prior art as a whole would suggest the combination of the elements in the ’531 patent claims, specifically the teachings of the Akiyama and Willrath patents which suggest suction chambers in chest drainage devices. That evidence would support modifying the Zuhdi-Kimmel device to include a suction chamber. Atrium, however, did not meet its evidentiary burden on obviousness based on the Zuhdi-Kimmel reference alone. Although multiple references may be used to establish the knowledge of one skilled in the art at the time of the invention, here, pursuant to the verdict form, the jury was directed to make its decision on a single reference. The standard previously set forth herein that requires both disclosure of the missing element and motivation for using an element as a property of the invention, is not met by the evidence at trial. In re Inland Steel Co., 265 F.3d at 1361. Under similar circumstances, the court in Motorola found that evidence of obviousness from other sources, such as the teachings from other references not identified by the jury, could not be used to infer the disclosure of a missing claim limitation. Motorola, 121 F.3d at 1473.
Atrium also relies on its expert’s testimony that substituting a flat plate for the closing means would render the ’531 patent obvious in light of the Zuhdi-Kimmel reference. However, no testimony was elicited from that expert as to why it would be obvious to one skilled in the art to add the missing element of a suction chamber to the Zuhdi-Kimmel reference. Neither disclosure of the element nor the motivation for using that element in the invention is found or suggested by the Zuhdi-Kim-mel reference or by the testimony at trial. Without the missing claim limitation or evidence of the motivation by one skilled in the art to combine elements from other sources, Atrium failed to meet its burden of proving obviousness by clear and convincing evidence.
C. Validity of the ’844 Patent Claims
The Delta Medical Reference
Claims 12, 13 and 16 of the ’844 patent were determined to be both anticipated and obvious in light of the Delta Medical Reference and device described therein. This reference by Dr. Siposs describes a “triple-action” or three-way cardiotomy device (VRV-200B) for “left ventricle decompression.” The reference describes and depicts an 8 cm long “in-line” device, placed in tubing to drain the left ventricle of the heart of blood and air during cardiac surgery. Downstream from the device, is a peristaltic pump and, downstream from this pump, is a collection/return vessel or cardiotomy reservoir. The problem solved is maintaining “adequate suction without introducing air into the ventricle during bypass surgery.” It suggests that the device can be included in the sump line at any point between the heart and the pump. The three-way action of this device is 1) limiting the vacuum in the line to a safe efficient value, 2) preventing flow toward the heart and 3) automatically venting downstream pressure to the atmosphere.
On cross examination, Dr. Elliot testified that the thoracic cavity included the chest and all of the organs within the chest. When asked to identify the elements of the Delta Medical reference device, he confirmed that three of the elements contained in the ’844 patent were included in the reference. Specifically, he identified a check valve, a positive pressure relief valve and a negative pressure relief valve as components of both his patent and the device. Further, he was aware of Dr. Siposs’ 3-way device (valve) and had used it in cardiac surgery. Although he concluded that the device would not work in his invention, Dr. Elliot contacted Dr. Si-poss to learn if similar manufacturing techniques could be used to produce one that would. Dr. Elliot testified that the device in the Delta Medical reference “vented blood” and did not normally operate in the absence of liquid. Moreover, according to Dr. Elliot, although the Delta Medical device did not depend on an aqueous environment to function, because of its high opening pressure and small diameter, it could neither effectively nor safely be used in a chest drainage device. He agreed that the reference cited a one-way “check-valve” similar to the type described in his invention. With regard to the cardiotomy reservoir shown, he testified that a vent at the top of the reservoir exists to relieve trapped air.
Dr. Kamm testified that he agreed with Dr. Elliot that the components in the Delta Medical reference were in the ’844 patent claims. He also testified that the reference described a thoracic drainage device. By pointing out each component, he concluded that the reference disclosed each and every limitation of claims 12,13 and 16 of the ’844 patent. He also confirmed that every cardiotomy reservoir was vented to release air.
The Tamada References,
Two references attributed to Tamada et. al. were chosen by the jury as rendering the ’844 patent claims obvious. The Tama-da I reference describes the use of a Heimlich valve to prevent the back-flow of air into a patient’s pleural cavity during aspiration. In describing the novelty of the invention, Tamada I compares this valve to prior devices, including waterseal type valves. Tamada I points out that waterseals are susceptible to being breached if collection bottles tip over, and suggests that inserting a Heimlich flutter valve, or dry valve, ensures the effectiveness of the device. The Tamada I reference describes a negative pressure safety device that utilizes differences in water pressure to prevent hyper-negative intra-thoracic pressures. Its stated purpose is to control an extrinsic pneumothorax, which may occur when a patient coughs strongly. Such forceful coughing may overcome the vacuum and exert excessive pressure on the one-way valve. The negative safety pressure device also allows adjustment of the suction pressure to compensate for air leakage within the system.
Tamada II explains that the water level of the safety pressure device in Tamada I may indicate intrathoracic pressure, without causing the pressure to fluctuate. Ta-mada' II teaches that the pressure can be modified by adjusting the submerged depth of the hollow tube in the safety pressure device. Tamada II suggests monitoring the water level in the safety pressure device to prevent lung failure. It also depicts a one-way “dry” Heimlich valve added to the system to relieve positive pressure.
Dr. Kamm testified that the Tamada references contained all of the elements of claim 12, except they use a water column as a high negative pressure relief valve. The jury heard from him that other inventions exist which use a dry-type valve with an aspiration jar to relieve negative pressure. Dr. Kamm suggested that since mechanical negative pressure relief valves had been used in a number of other medical devices and patents, he would have been very surprised if one of ordinary skill in the art would not have made the combination. He further commented that the combination is suggested in a paper by Enerson. Moreover, Dr. Kamm testified that a positive pressure relief valve was present in the Tamada II reference and that it would have been obvious to insert the valve, along with the other elements of claims 12, 13, and 16, into a chest drain.
Under cross examination, Dr. Kamm confirmed that one of ordinary skill in the art would know that the water column in the Tamada references could be replaced with a mechanical check valve. He found support for this conclusion in the Puder-baugh and Enerson references. However, when specifically asked, Dr. Kamm neither confirmed that the Tamada references alone suggested using a dry valve as a high negative pressure relief device, nor the motivation for that substitution. He did not agree that mechanical valves operated differently than water columns.
Discussion
Claims 12, 13 and 16 of the ’844 patent were found anticipated by the Delta Medical reference. These claims were also found to be obvious in light of the Tamada I and Tamada II references. Claims 1,16, 17 and 18 of the ’531 patent were held anticipated and obvious in light of the Zuh-di-Kimmel regulator.
On a motion for JMOL, substantial evidence is required to support the jury’s finding under the clear and convincing standard that each and every element of the contested claims in the ’844 and ’531 patents is present in the prior art. The same evidentiary standard applies when determining obviousness. Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1570 (Fed.Cir.1986).
Anticipation of the ’844 patent by the Delta Medical Reference
The Delta Medical reference, and the device described therein, does not anticipate the claims of the ’844 patent, since a reasonable jury could not have found by the clear and convincing standard that the reference contained each and every claimed element with the same structure and functioned in the same way.
Atrium argued that the Delta Medical device has similarly named components as those in the ’844 patent claims. The device arguably is a thoracic drainage apparatus since it provides for drainage of the heart, an organ in the thoracic cavity. Atrium demonstrated that the device has a check valve to stop the return of blood and air to the heart, and another structure which relieves both positive and negative pressure. However, in light of the part-to-part relationships that give the claims in question their meaning, the Delta Medical device does not contain the same components which function similarly to those in the ’844 patent.
Dr. Elliot’s invention, a “dry-suction apparatus,” is an improvement over systems with water-based valves and designed to work in the absence of water to assist a patient’s breathing. The Delta Medical device, on the other hand, is designed to remove blood and air from the heart. Dr. Elliot testified the Delta Medical device “vented blood,” and although possibly is “waterless” relative to his invention, it is not interchangeable or a substitute for the waterless valves in his invention.
Dr. Elliot, as a thoracic surgeon, was familiar with and used the Delta Medial device. He considered the mechanical characteristics of the Delta Medical device and felt they were unusable and unsuitable in his invention. While Dr. Elliot confirmed that the device has a negative pressure relief valve, he never stated, nor was he asked, whether this valve is structurally or functionally the same in both devices. The negative pressure relief valve of the ’844 patent is designed to allow air back into a patient’s chest cavity when needed. However, the same valve described in the Delta Medical device automatically limits the vacuum in the “line” downstream between the device and the reservoir. It does not reintroduce air to the heart or thoracic cavity. Even if it could do so in sufficient volume to be effective, the reference describes this potential occurrence as a “tragic mistake” that the device is intended to prevent.
Claim 16 of the ’844 patent has a positive pressure relief valve “operatively associated with” and designed to vent the air space above the fluid collection chamber. Testimony was elicited by both parties that the cardiotomy reservoirs in the Delta Medical reference have built-in vents, but not positive pressure valves, to the atmosphere. Atrium points to the Delta Medical reference as suggesting that a positive pressure relief valve could prevent the problem of reservoir pressure. In fact, the reference states that the check valve prevents the tragic effects caused by reservoir pressure by preventing air or blood •flow towards the heart. It does not provide that a positive pressure relief valve can be used to vent the cardiotomy reservoir. Rather, the Delta Medical reference teaches away from venting the cardiotomy reservoir by suggesting that a surgeon can place the device at any point in the sump line between the heart and pump, since its principle use is as a safety device to prevent blood or air from flowing into the patient due to inadvertent pump reversal.
Considering the differences between the design and function of the Delta Medical device and the Elliot patent, a reasonable jury could not have found that the reference anticipated the ’844 patent claims by clear and convincing evidence. Atrium’s treatment of the claims as a catalog of parts ignored the part-to-part intra relationship of the claims and their relationship to the specification. Since the court is responsible to ensure that the patents are properly evaluated by the jury under the statutory presumption of validity, the verdict finding that the ’844 patent is invalid as anticipated is reversed.
Obviousness of the ’844 patent by the Tamada I and Tamada II References
The jury held that claims 12, 13 and 16 of the ’844 patent were obvious under the Tamada I and Tamada II references. The jury selected only these two references from a list of four possibilities. However, the Tamada references do not render the ’844 patent claims obvious since they do not suggest any motivation to replace a water based multi-function high negative pressure relief valve with a mechanical valve. Expert testimony provides no evidence that the Tamada references alone would render the claims obvious. The fact that the Tamada references suggest the use of a mechanical valve in one part of their inventions, and not in another, inherently teaches away from the ’844 invention. Although other prior art references in evidence indicate the knowledge of one skilled in the art at the time of the invention, the jury did not select those as rendering the ’844 patent obvious. This limited selection by the jury evidences that Atrium did not meet the clear and convincing standard.
The parties agree that the elements of the ’844 patent claims are met by the Tamada references, except that these publications describe a drainage device containing a water column-based high negative pressure relief valve instead of a mechanical valve. Atrium argues that the motivation existed to replace the water column-based, high pressure valve with a mechanical valve. Specifically, Dr. Kamm testified that one of ordinary skill in the art would have had the knowledge and motivation to modify the Tamada references. He indicated that the Puder-baugh reference suggests that mechanical check valves exist and the Enerson reference suggests that the substitution could be made, thereby insinuating that one skilled in the art would have had the invention in his possession. Atrium argues that Dr. Kamm’s testimony, combined with the Tamada references, is enough to meet the standard of clear and convincing evidence obviousness. However, contrary to Atrium’s argument, by only choosing the Tamada references, the jury explicitly concluded that teachings of these other references, despite being within the knowledge of one skilled in the art, were not helpful or relevant.
Atrium points to B.F. Goodrich as an example of where the Federal Circuit upheld a verdict of obviousness in light of a single prior art reference. B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1582 (Fed.Cir.1996). In contrast to B.F. Goodrich, where the court determined that the differences between the claimed and prior art inventions were minor, in the present matter the ’844 patent specifies a waterless high negative pressure valve, while the Tamada references recite a water-based valve. This distinction is clearly evident in the ’844 patent specification which details a “waterless” system for thoracic drainage. Atrium’s expert testified to an implicit suggestion or motivation to combine the understanding of one skilled in the art at the time of the invention with the Tamada references to render the ’844 patent claims obvious. The test for an “implicit showing” of obviousness is “what the combined teachings, knowledge of one of ordinary skill in the art, and the nature of the problem to be solved as a whole would have suggested to those of ordinary skill in the art.” In Re Kotzab, 217 F.3d 1365, 1370 (Fed.Cir.2000)
Kotzab requires that “broad conclusory statements standing alone are not ‘evidence’.” Id. Moreover, Kotzab overturned the PTO’s rejection due to obviousness. In Kotzab, a PTO examiner concluded that the term “one system” was the same as a limitation of “one sensor.” The court rejected the examiner’s decision, finding that there was no evidence on the record to support such a conclusion. The court determined that both the examiner and the Board fell into the “hindsight trap,” by comparing element by element, instead of, considering the invention in the context of the teaching of the entire reference. Id. Rather, the analysis must be based on the “reason [that] the skilled artisan, with no knowledge of the claimed invention, would have selected these components for combination in the manner claimed.” Id. Atrium’s implicit motivation is refuted by the jury’s limited selection.
The mere conclusory testimony elicited from Dr. McDonald regarding the Tamada references and the knowledge of one skilled in the art do not render the ’844 claims obvious by a clear and convincing standard. No evidence was presented as to why the Tamada references alone provide the motivation to-replace the water-based negative pressure valve with a mechanical valve. No suggestion exists in the Tamada references motivating a skilled artisan to select a mechanical valve as a replacement for the water-based multifunction valve. In fact, the Tamada references, by implication, teach away from this substitution because, despite suggesting the use of a mechanical valve to prevent back flow to a patient, they do not suggest its application as a high negative pressure relief device as the ’844 patent requires.
Atrium cannot now argue that the jury made its determination based on the prior art references in evidence or the testimony of knowledge of one skilled in the art at the time of invention. Motorola, Inc. v. Interdigital Tech. Corp., 121 F.3d 1461, 1467. In Motorola, the Federal Circuit affirmed the reversal by the trial court of a verdict of obviousness, since no motivation was evident to combine the elements from the two references selected, particularly in the absence of any evidentiary support from one skilled in the art. Neither con-clusory testimony regarding the knowledge of one skilled in the art, nor the other prior art references in evidence, but not relied upon by the jury, can be used to bootstrap the references selected.
Genzyme demonstrated long felt need and commercial success as secondary considerations of nonobviousness. Although these elements are never conclusive, they support the court’s finding of nonobviousness. Genzyme points to the testimony of Dr. McDonald, specifically, his review of seven secondary factors as indicia of non-obviousness. He discussed the commercial success of the patented products, selling over three million units, while competitors struggled to capture a tiny share of the market. The contrast was compelling. The technology at issue was licensed extensively prior to Genzyme’s purchase of the ’844 patent with payments in royalties to Dr. Elliot of several million dollars. Genzyme offered evidence that Atrium analyzed the features of the dry/dry devices under the Elliot patent and included them in its products. Thus, the evidence in support of the secondary considerations in conjunction with the other evidence of non-obviousness demonstrates the validity of the ’844 patent.
V. GENZYME’S MOTION FOR JMOL ON INFRINGEMENT OF THE ’531 AND ’844 PATENTS
A. Legal Standard
Infringement
A patent is directly infringed when a person “without authority makes, uses, or sells any patented invention, within the United States during the term of the patent -” 35 U.S.C 271(a). Novartis Pharmaceuticals Corp., v. Eon Labs Mfg., Inc., 234 F.Supp.2d 464, 467 (D.Del.2002). A patent owner may prove infringement by literal infringement or the doctrine of equivalents. Literal infringement occurs where each element of at least one claim of the patent is found in the alleged infringer’s product. Id. At trial, Genzyme did not proceed on the basis of the doctrine of equivalents, but solely on direct infringement.
Determining infringement is a two step process. First, the court must construe the asserted claims to ascertain their meaning and scope and then the claims are compared to the accused device. Union Carbide Chems., Plastics Tech. Corp. v. Shell Oil Co., 163 F.Supp.2d 426, 437 (D.Del.2001). Genzyme had to prove, by a preponderance of the evidence, that every claim limitation was met by the accused device. Unlike the analysis of infringement under a motion for summary judgment, where a court compares the accused products with properly construed claims, or when the Federal Circuit reviews an appeal de novo, the review of a jury’s decision of non-infringement via a JMOL motion should be limited to whether substantial evidence supports the verdict under the appropriate jury instruction. Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314, 1320 (Fed.Cir.2003).
A number of the asserted claims of the patents-in-suit include limitations drafted in “means-plus-function” form, where the limitation does not describe a specific structure, but instead describes a function and claims a “means” for accomplishing that function. Pursuant to 35 U.S.C. § 112, ¶ 6, limitations drafted in means-plus-function form are construed to “cover the [functionally] corresponding structure, material, or act described in the specification and equivalents thereof.” Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1266-67 (Fed.Cir.1999). Section 112, ¶ 6 provides a compromise: patentees may express a limitation in their patent claims “as a means or a step for performing a specified function without the recital or structure ... in support thereof.” Such a claim, however, will not be interpreted to cover all structures which would perform that function, but only “the corresponding structure ... described in the specification and equivalents thereof.” 35 U.S.C. § 112, ¶ 6; see also J & M Corp. v. Harley-Davidson, Inc., 269 F.3d 1360, 1367 (Fed.Cir.2001) (“the scope of such [means-plus-function] claim language is sharply limited to the structure disclosed in the specification and its equivalents”). J & M v. Harley-Davidson also reminds that comparing equivalents under literal infringement is a question of fact.
“Literal infringement of a claim containing a means clause requires that the accused device perform the identical function as that identified in the means clause and do so with structure which is the same as or equivalent to that disclosed in the specification.” Micro Chem., Inc. v. Great Plains Chem. Co., 103 F.3d 1538, 1547 (Fed.Cir.1997). The duty to link or associate structure to a claimed function is the quid pro quo for the convenience of employing the means-plus-function claiming technique of § 112, ¶ 6. B. Braun Medical Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed.Cir.1997). However, the word “equivalents” under § 112, ¶ 6 should not be confused with the doctrine of equivalents. When applying the means-plus-function paragraph of § 112, ¶ 6 the “sole question is whether the single means in the accused device which performs the function stated in the claim is the same as or an equivalent of the corresponding structure described in the patentee’s specification as performing that function.” Intel Corp. v. ITC, 946 F.2d 821, 842 (Fed. Cir.1991), quoting D.M.I., Inc. v. Deere & Co., 755 F.2d 1570, 1575 (Fed.Cir.1985). Further, paragraph 6 of § 112 limits a claim “from every possible means to those which are ‘equivalent.” ’ Id.
Properly understood section 112 ¶ 6 operates more like the reverse doctrine of equivalents than the doctrine of equivalents because it restricts the scope of the literal claim language.
Johnston v. IVAC Corp., 885 F.2d 1574, 1580 (Fed.Cir.1989). As a result, § 112, ¶ 6 “rules out the possibility that any and every means which performs the function specified in the claim literally satisfies that limitation.” Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 934 (Fed.Cir.1987) (en banc), (emphasis in the original).
Discussion
The D’Antonio Patent
Are a flat plate and a spherical ball equivalent structures?
In its post trial motion, Genzyme begins by arguing that no reasonable jury could find that a biased, pressure-regulating flat plate is not equivalent to a biased pressure-regulating ball within an opening, or a hinged door, if it achieves the same result. Genzyme maintains that each is equivalent and that Atrium’s chest drains literally include all elements of the asserted claims. Genzyme employs doctrine of equivalents language when expressing that the closing means in each device “operates in substantially the same way to perform the same function to achieve the same result.” Alternately, Atrium contends that there is no legally sufficient basis to find in favor of Genzyme under JMOL, since there is substantial evidence to support the jury’s verdict, citing Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed.Cir. 1998) and Dawn Equip. Co. v. Kentucky Farms, Inc., 140 F.3d 1009, 1014 (Fed.Cir.1998). Atrium emphasizes the prosecution history of the D’Antonio patent in which the “biased regulating ball” was distinguished over “flap-type” valves in the prior art. Atrium argues that the court must consider such evidence in a light most favorable to the non-moving party and disregard evidence that the jury was not “required to believe,” relying on Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000).
Here, the issue is whether there was substantial evidence presented during the trial that a flat plate and spherical ball are structural equivalents when placed between the dividing means and used to regulate the pressure between the chambers of a thoracic drainage device. Where substantial evidence of equivalents is found, the court then determines if the verdict of non-infringement would be a reasonable conclusion supported by the findings. Even if there is doubt that evidence existed to challenge equivalents, this court must still provide the benefit of doubt to Atrium, and resolve the motion in its favor. It is Genzyme’s burden to prove that there was little evidence to substantiate the verdict of non-infringement. Genzyme has not met that burden. Accordingly, this court concludes that substantial evidence was presented to the jury, and the jury came to the reasonable verdict of non-infringement as a result.
Genzyme’s argument that, as a matter of law, Atrium’s device is “the same as” the D’Antonio patent and that it is entitled to JMOL of infringement based on the claims construction provided to the jury, must fail for two reasons. First, it uses doctrine of equivalents “language” to convince the court that, in defining the. closing means at issue, both devices are the same. Gen-zyme exclusively argued (and the court only instructed the jury on) literal infringement.
At trial, there was significant evidence for the jury to consider regarding the structural equivalents of a spherical ball and flat plate as described within a suction regulator. Testimony from expert witnesses, the patent holder and opinions of representatives from both parties were presented. Numerous exhibits were provided to the jury to view and inspect, for example, DX 993 and PTX 1047, along with the patents and claim definitions to assist in its determination. Both sides presented extensive evidence on the issue of equivalents — clearly, more than a “mere scintilla” — and