Opinion
Civil Action No. 98-12611-EFH
December 19, 2002.
MEMORANDUM AND ORDER
Following an eleven-day trial, a jury found that the defendants' EC-5000 excimer laser system, a device used to perform laser vision surgery to correct refractive vision disorders, literally infringed all the claims of the "Marshall patent," U.S. Patent No. 4,941,093 (issued Jul. 10, 1990), and the "Azema patent," U.S. Patent No. 4,973,330 (issued Nov. 27, 1990), that were asserted by the plaintiff (Summit Technology, Inc.). Before this Court now is the defendants' (Nidek Co., Ltd., et al.) renewed motion for a judgment as a matter of law (JMOL) seeking to overturn the jury's verdict of literal infringement of both patents.
In deciding defendants' motion for JMOL, the Court must consider all the evidence in a light most favorable to the non-mover (Summit) and draw reasonable inferences favorable to Summit, without determining the credibility of witnesses or substituting the Court's own choice for that of the jury. E.g., Forest Laboratories, Inc. v. Abbott Laboratories, 239 F.3d 1305, 1309 (Fed. Cir. 2001); Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir. 1984). Following these guidelines, the Court must determine whether the evidence introduced at trial constitutes "substantial evidence" in support of the jury's findings. Perkin-Elmer, 732 F.2d at 893. "Substantial evidence" is such relevant evidence, from the record taken as a whole, as might be accepted by a reasonable mind as adequate to support the finding under review. Id. If Nidek shows that substantial evidence does not support the jury's factual findings, it will prevail on its motion for JMOL. See Forest Laboratories, 239 F.3d at 1309 (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). The ultimate inquiry is whether a reasonable jury, given the record before it viewed as a whole, could have arrived at the conclusion it did. Dawn Equip. Co. v. Kentucky Farms, Inc., 140 F.3d 1009, 1014 (Fed. Cir. 1998); accord Lifescan, Inc. v. Home Diagnostics, Inc., 103 F. Supp.2d 345, 350-51 (D.Del. 2000); 9A Charles A. Wright Arthur R. Miller, Federal Practice and Procedure § 2524 (3d ed. 1995) ("[T]he federal courts do not follow the rule that a scintilla of evidence is enough to create an issue for the jury. The question is not whether there is literally no evidence supporting the party against whom the motion is directed but whether there is evidence upon which the jury properly could find a verdict for that party.").
A jury's determination of infringement is considered to be a question of fact. Union Carbide Chemicals Plastics Technology Corp. v. Shell Oil Co., 308 F.3d 1167, 1177 (Fed. Cir. 2002).
The defendants argue that there is no legally sufficient evidentiary basis for a reasonable jury to have found for Summit on its claims of patent infringement, and that Nidek is therefore entitled to judgment of non-infringement as a matter of law with respect to all asserted claims of the Marshall and Azema patents.
The Marshall Patent
With regard to the Marshall patent, there are three independent claims at issue: claims 1, 15 and 25. In order for the jury to have decided that the EC-5000 infringes the Marshall patent, it needed only to have found that the Nidek machine literally infringes at least one of these independent claims. See Teleflex, Inc. v. Ficosa North America Corp., 299 F.3d 1313, 1323 (Fed. Cir. 2002) (stating that a finding of infringement requires the fact finder to determine whether all of the limitations of at least one claim are present in the allegedly infringing device). Before this Court can lawfully overturn the verdict as to the Marshall patent, then, Nidek must show that there was not "substantial evidence" at trial sufficient for the jury to find that any of the asserted independent claims was infringed. In other words, Nidek bears the heavy burden of establishing that no reasonable jury, given the record before it, could have concluded that even one of the asserted independent claims was infringed. If Nidek can satisfy this burden, however, this Court must overturn the jury's verdict as to the entire Marshall patent.
Asserted claims 3, 17, 27, 28, 29 and 30 of the Marshall patent are dependent on one of claims 1, 15 or 25 and cannot be infringed unless the claim on which they depend is also infringed. See Wahpeton Canvas Co., Inc. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed Cir. 1989) ("It is axiomatic that dependent claims cannot be found infringed unless the claims from which they depend have been found to have been infringed . . .").
Claims 1, 15 and 25 of the Marshall patent each contain an element that requires a beam dimension control means to "vary" the area of the eye exposed to the laser, "while maintaining a substantially constant energy per unit area during each pulse." (U.S. Patent No. 4,941,093, column 24, lines 26-28; column 25, lines 67-68; column 27, lines 31-33) (emphasis added). Nidek argues that this language, which is common to each of the asserted independent claims, is not literally met by the EC-5000 and, therefore, the EC-5000 does not literally infringe the Marshall patent. In other words, Nidek contends that the EC-5000's beam dimension control means does not function in the precise manner described in claims 1, 15 or 25 of the Marshall patent.
Claim 1 actually uses the word "varying." Claims 15 and 25 use the word "vary."
In its claim construction order dated June 25, 2002, the Court interpreted the asserted independent claims. The Court construed the portion of claim 1 that is now at issue as requiring "optical component(s) in the path of the laser beam, to vary an area on the surface to which the pulses from the laser are delivered but, at the same time, to have each pulse delivered to the surface have substantially the same energy per unit area." (emphasis added). Similarly, the Court construed the relevant portion of claim 15 as requiring the laser light to be "controlled so as to optically vary the area hit by the light during a succession of pulses of the laser, which pulses have substantially the same energy per unit area. . . ." (emphasis added). Finally, the Court's construction of claim 25 requires "a beam dimension control means to vary the area of exposure of the cornea to the light, while maintaining substantially the same energy per unit area for each pulse to which the cornea is exposed. . . ." (emphasis added). In each of these claim constructions the Court used slightly different words to say the same thing: the energy per unit area of each pulse that hits the eye must remain substantially constant even as the area of the cornea being exposed to the laser pulses is varied (i.e., when the aperture size changes).
The Court's claim construction makes it clear, then, that the contested portion of the beam dimension control means element in claims 1, 15 and 25 requires simultaneity. In other words, each claim requires that as the area of cornea exposed to the laser pulses changes (i.e., as the area of exposure "varies"), the energy per unit area of each pulse that hits the eye must also remain "substantially the same." The beam dimension control means element in each asserted independent claim is not satisfied if the energy per unit area of pulses hitting the eye is substantially the same when one area of the cornea is exposed to the laser, but not substantially the same when a different area is being exposed.
The only question left to be resolved is how the phrase "substantially the same energy per unit area" should be defined. The claim construction order makes it clear that pulses that hit the cornea have substantially the same energy per unit area if they "ablate approximately the same depth of material." (emphasis added). When we implement this definition into the Court's analysis we see that claims 1, 15 and 25 of the Marshall patent each require a "beam dimension control means" to function in a manner that: (1) varies the area of cornea exposed to the excimer laser pulses, and at the same time (2) has each laser pulse that hits the cornea ablate approximately the same depth of material. If the trial testimony failed to provide "substantial evidence" sufficient for a reasonable jury to find that the EC-5000 contains a structure that performs this identical function, as it has been explicated in the Court's construction of claim 1, then this Court must overturn the jury's verdict that the Nidek machine literally infringes claim 1. See Kemco Sales, Inc. v. Control Papers Co., Inc., 208 F.3d 1352, 1364 (Fed. Cir. 2000). Likewise, if the trial record fails to show "substantial evidence" sufficient for a reasonable jury to properly decide that the Nidek machine literally meets the limitations in claims 15 and 25, as they have been construed, then this Court also must overturn the jury's verdict as to claims 15 and 25. See, e.g., Biovail Corp. International v. Andrx Pharmaceuticals, Inc., 239 F.3d 1297, 1302 (Fed. Cir. 2001); Johnston v. IVAC Corp., 885 F.2d 1574, 1577-78 (Fed. Cir. 1989).
The infringement standard applicable to claim 1 differs slightly from the standard applied to claims 15 and 25 because claim 1 is the only claim of the three in which the element at issue is a means-plus-function limitation. A means-plus-function limitation is infringed only if the accused device contains a structure that performs the identical function to that recited in the limitation, and that structure is either identical or equivalent to the corresponding structure or structures disclosed in the patent specification. See Kemco Sales, 208 F.3d at 1364.
Trial Evidence Pertaining to the Marshall Patent
In response to the defendants' motion, the plaintiff has set forth essentially three evidentiary bases which it claims amount to substantial evidence sufficient to support the jury's verdict that the EC-5000 infringes the independent claims of the Marshall patent. First, the plaintiff cites the following portion of Dr. Ray Sayano's (a Nidek employee) trial testimony as he was being examined by the plaintiff's attorney:
Q. So, isn't it true that the EC-5000 excimer laser system, each pulse delivered to the cornea ablates approximately the same depth of material?
A. I don't know.
Q. You don't know. You told the FDA that is the way it works, right?
A. Yes. That is what I said.
Q. And you told the FDA the truth, right?
A. Yes.
(Tr. day 4, p. 155, lines 16-24 [Sayano]). The plaintiff construes this testimony as an admission of infringement upon which the jury could have relied. It was no such thing. Defendants correctly point out that Dr. Sayano's testimony cannot be fully understood without reading it in context. Dr. Sayano's answers to questions which immediately preceded the excerpted testimony above, provide the necessary context:
Q. We can agree Figures 8(a) through 8(e) show that each pulse delivered to the cornea ablates approximately the same depth of material, right?
A. Each pulse can, yes.
Q. That is what you told the FDA, right?
A. Yes. At a given aperture.
(Tr. day 4, p. 155, lines 10-15 [Sayano]) (emphasis added). In other words, Doctor Sayano did not admit that each pulse delivered to the cornea by the EC-5000 system always ablates approximately the same depth of material. Rather, Doctor Sayano's testimony admitted only that Figure 8(a) through 8(e) in Nidek's FDA submissions illustrate that pulses ablate the same depth of material at one particular "given aperture." This is not sufficient evidence to prove that the EC-5000 literally infringes any of the Marshall patent's asserted claims. As was explained earlier, the claims at issue require that each pulse ablate approximately the same depth of material not only at one particular aperture, but also as the area exposed to the laser changes. In this instance, then, the plaintiff's evidence that pulses ablate to a uniform depth at one particular aperture size lacked the one additional component necessary to find literal infringement, namely, what happens when the aperture size changes, and the area of the cornea exposed to the pulses is thereby varied? Doctor Sayano's testimony, when read in context, simply cannot be relied on to prove infringement in this case.
The second evidentiary basis upon which Summit attempts to support the jury's verdict is closely related to the first. During cross examination of Dr. Peter Oesterlin (an expert testifying for Nidek), Summit's attorney posed the following hypothetical question:
Q. Sure. If we assume that each pulse delivered to the surface in the EC-5000 ablates approximately the same depth of material, then the EC-5000 and Nidek infringe every single asserted claim of the Marshall patent?
A. That's right.
(Tr. day 8, p. 128, lines 8-12 [Oesterlin]). Because the question was hypothetical in nature, Doctor Oesterlin's answer, by itself, could not be properly relied on by the jury to find infringement. Plaintiff's attorney followed this hypothetical by trying to get Doctor Oesterlin to testify that each pulse emitted by the EC-5000 ablates approximately the same depth of material. The attempt failed:
Q. What his honor said was that each pulse delivered to the surface has substantially the same energy per unit area, which means that each pulse ablates approximately the same depth of material, right?
A. Right.
Q. And that is the way the EC-5000 works, isn't it?
A. No.
(Tr. day 8, p. 128, lines 24-25 — p. 129, lines 1-5 [Oesterlin]) (emphasis added). Doctor Oesterlin's testimony clearly states his opinion that each pulse of the EC-5000 does not ablate approximately the same depth of material. Immediately thereafter, then, plaintiff's attorney turned Doctor Oesterlin's attention to the excerpted portion of Doctor Sayano's testimony discussed earlier in this decision. After being presented with this testimony, Doctor Oesterlin testified to the following:
Doctor Sayano's testimony was as follows:
Q. So, isn't it true that the EC-5000 excimer laser system, each pulse delivered to the cornea ablates approximately the same depth of material.
A. I don't know.
Q. You don't know. You told the FDA that is the way it works, right?
A. Yes. That is what I said.
Q. And you told the FDA the truth, right?
A. Yes.
(Tr. day 4, p. 155, lines 16-24 [Sayano]).
Q. If the jury believes Dr. Sayano, the EC-5000 infringes the Marshall patent, right?
A. Yes.
(Tr. day 8, p. 130, lines 14-16 [Oesterlin]). The plaintiff now argues that Doctor Oesterlin's answer to this question is evidence upon which the jury could have properly relied to find infringement. The plaintiff is mistaken. As was explained earlier in this decision, the portion of Doctor Sayano's testimony that Doctor Oesterlin considered in answering this question was not presented to Doctor Oesterlin in its full and proper context and was therefore misleading. As such, no jury could properly rely upon this portion of Doctor Oesterlin's testimony as grounds for finding the EC-5000 literally infringed the Marshall patent.
Finally, the third evidentiary basis upon which Summit attempts to support the jury's verdict with regard to claims 1, 15 and 25 of the Marshall patent was the trial testimony of Summit's expert, Dr. Michael Feld. Toward the beginning of his testimony, Doctor Feld offered a general conclusion that the Nidek EC-5000 device infringes "nine claims" of the Marshall patent. (Tr. day 3, p. 22, lines 12-20 [Feld]). Through the course of his direct testimony, Doctor Feld offered additional conclusions as to each element of each claim at issue in the Marshall patent. These additional conclusions were directed toward the precise language of the claim construction order. (Tr. day 3, pp. 30-50 [claim 1]; pp. 51-56 [claim 15]; pp. 58-61 [claim 25] [Feld]). No matter how precisely they were worded however, Doctor Feld's conclusions, on their own, are not sufficient evidence upon which a reasonable jury could properly find infringement. Summit failed to set forth any evidence sufficient to sustain Doctor Feld's conclusions concerning the beam dimension control means element in each of claims 1, 15 and 25, thereby rendering such conclusions baseless.
Virtually all of the testimony Doctor Feld gave that was relevant to Nidek's alleged infringement of claims 1, 15 and 25 was made in response to direct examination questions regarding claim 1. Doctor Feld acknowledged at trial that with regard to the portion of claim 1 at issue in this case, he relied only on the Court's claim construction order and "the FDA submissions that Nidek provided" to form the basis for his opinion on infringement. (Tr. day 8, p. 43, lines 19-20 [Feld]). Doctor Feld relied on no scientific data other than Nidek's FDA submissions. The portions of FDA submissions on which he relied most heavily were Figures 7 and 8 of Nidek's patent application (Joint Exhibit 10 at NTI-FDA 00011218). With regard to Figure 8, Doctor Feld testified as follows:
With regard to Nidek's alleged infringement of the relevant portions of claims 15 and 25, Doctor Feld offered nothing but bare conclusions. In making these conclusions, Doctor Feld relied on the answers he gave concerning claim 1. For example, when being questioned regarding claim 15, Doctor Feld testified:
Q. And do those pulses have substantially the same energy per unit area, meaning ablate approximately the same depth of material?
A. Yes, they do, as we saw.
(Tr. day 3, p. 55, lines 18-21 [Feld]) (emphasis added)
And with regard to claim 25:
Q. Does the EC-5000 work that way?
A. That is exactly how it works, as we've seen in numerous other claims.
(Tr. day 3, p. 61, lines 13-15 [Feld]) (emphasis added)
Q. This Figure 8, the diagram that Nidek gave to the FDA show[s] that each pulse delivered to the cornea ablates approximately the same depth of material?
A. Yes, it does.
Q. All right. Do you agree?
A. I do, of course.
(Tr. day 3, p. 44, lines 18-23 [Feld]). This testimony is not evidence upon which a reasonable jury could rely to find infringement. Figure 8 provides an insufficient basis for a finding of infringement because it shows the ablation process of an EC-5000 device when it is set at one particular aperture only. Defendants concede that Figure 8-A through 8-E depicts each pulse ablating approximately the same depth of material, but correctly refute that such evidence can, by itself, support a finding of literal infringement. The jury is bound by the Court's claim construction which requires that each pulse ablate approximately the same depth of material not only at one aperture size, but also as the aperture size changes and the area of the cornea exposed to the laser is thereby varied. Figure 8 and, therefore, Doctor Feld's testimony, simply do not speak to this additional requirement because Figure 8 relates to one particular aperture only.
During direct examination, Doctor Feld offered no evidence as to the effect each individual pulse has when the aperture (the iris diaphragm) in the EC-5000 is at a size different than that shown in Figures 7 and 8 of Nidek's FDA submissions. In other words, Doctor Feld failed to offer any evidence that could sustain his conclusion that the EC-5000 literally infringes the beam dimension control means element in claim 1. The only further testimony Doctor Feld gave regarding Nidek's alleged infringement of claim 1 concerned the overall, combined effect of successive EC-5000 pulses. (Tr. day 3, pp. 45-50 [Feld]). The remainder of Nidek's FDA submissions upon which Doctor Feld relied also went to this issue of combined effect.
On the subject of combined effect, Doctor Feld testified that a succession of EC-5000 pulses ultimately achieves a uniform depth of ablation. Defendants do not dispute this testimony because uniform ablation is, after all, the ultimate end which the EC-5000 seeks. This fact, however, does not mean the EC-5000 literally infringes claims 1, 15 or 25 of the Marshall patent. The EC-5000 can only infringe these claims if each pulse ablates approximately the same depth of material, no matter what the size of the aperture. Testimony regarding the combined effect of individual pulses is inapposite on the issue of literal infringement and could not properly be relied on by the jury for purposes of determining whether the EC-5000 infringes.
A sampling of Doctor Feld's testimony is as follows:
Q. But does the EC-5000 produce a uniform ablation of corneal tissue?
A. Yes, it does.
(Tr. day 3, p. 45, lines 8-10 [Feld]) (emphasis added)
A. It says: This means that . . . the pulses are combined and a uniform depth of ablation is achieved.
Q. Is that an accurate description of the way the EC-5000 works?
A. Yes, it is.
(Tr. day 3, p. 45, lines 16-23 [Feld]) (emphasis added)
Q. As a physicist, from that set of conditions, would that achieve a uniform depth of ablation?
A. Yes, those are just the conditions needed to be able to achieve a uniform depth of ablation[.]
(Tr. day 3, p. 49, lines 14-17 [Feld])
Q. . . . it says that the pulses are combined and a uniform depth of ablation is achieved. What does it mean for pulses to be combined?
A. In this case, what it means is that the individual pulses produced this wide area beam which is a composite beam. They're combined spatially so that the net effect is to, is to have wide area of removal of material.
(Tr. day 3, p. 49, lines 22-25 — p. 50, lines 1-3 [Feld]) (emphasis added)
In none of these examples was Doctor Feld referring to the effect of an individual pulse. Rather, he was referring only to the combined effect of numerous pulses.
The plaintiff offers no additional evidence which it believes the jury could have properly relied on to find that each asserted independent claim in the Marshall patent was infringed. This Court rules that the plaintiff's evidence, taken as a whole, does not constitute substantial evidence in support of the jury's verdict with regard to claims 1, 15 and 25. The Court's conclusion that no reasonable jury could have properly arrived at the finding made by this jury is rendered even clearer when one considers the totality of relevant evidence presented at trial, namely, the evidence favoring the defendants.
During cross examination of Doctor Feld, the defendants' attorney asked him to reconsider Figures 7 and 8, the same diagrams on which Doctor Feld had previously relied in concluding that the EC-5000 infringed the Marshall patent. Because Doctor Feld's direct examination testimony explained only the ablation caused by pulses that pass through at one particular aperture size, defendants' counsel, during cross-examination, had Doctor Feld testify as to what happens when the opening of the iris diaphragm is made smaller, thereby varying the area of ablation (i.e., the area of cornea exposed to the laser). Once defendants' counsel presented Figures 7 and 8 in this manner, Doctor Feld admitted that as the iris diaphragm in the EC-5000 changes size, the individual pulses emitted by the machine ablate to different depths:
Q. In the Nidek system, isn't it true that different pulses ablate corneal tissue to different depths?
A. The word substantially is also in there, but, yes.
Q. So that as that iris diaphragm opens or closes, pulses get through, and the depth of ablation on those pulses is different, correct?
A. Well, Counselor, I've studied this mathematically, let me just say that.
Mr. Seigel: Your honor, could I get an answer to the question?
A. Correct.
Q. Thank you. And in fact Nidek's data to the FDA said that, didn't it?
A. Said what?
Q. That the pulses ablate to different depths, because the pulses are not uniform?
A. That's correct.
(Tr. day 4, p. 108, lines 5-21 [Feld]). This testimony demonstrates precisely in what respect the plaintiff's evidence at trial was lacking. The plaintiff failed to confront the essential issue as to what happens when, during the course of an EC-5000 procedure, the area of ablation changes. Once the plaintiff's expert was cross-examined on that topic, he gave testimony that cut against the plaintiff's case regarding infringement of the Marshall patent. Doctor Feld conceded not only that different pulses ablate "different" depths of corneal material, but also that the difference in ablation depths between pulses can be substantial. This testimony was corroborated by Nidek's expert Doctor Oesterlin who testified that the ablation depth caused by one pulse can be up to six times greater than the ablation depth caused by another pulse. (Tr. day 8, p. 110, lines 7-13 [Oesterlin]).
During cross examination, Doctor Feld testified to the following while referring to Figures 7 and 8 of Nidek's FDA submissions:
Q. And that pulse, correct, gets through to the eye, right?
A. Yes, absolutely.
Q. And it ablates corneal tissue, right?
A. Yes. A little nibble is taken out.
Q. It ablates tissue to a substantially different depth than that pulse, doesn't it?
A. Yes, it does.
(Tr. day 4, p. 106, line 25 — p. 107, lines 1-6 [Feld]) (emphasis added).
The Court need not revisit the multitude of additional testimony and scientific data that the defendants presented at trial to bolster their case for non-infringement of the Marshall patent. The insufficiency of plaintiff's evidence, along with Doctor Feld's admissions during cross examination, are adequate grounds to decide that no reasonable jury, given the record before it viewed as a whole, could have found that the EC-5000 literally infringed the asserted claims of the Marshall patent.
The Azema Patent
With regard to the Azema patent, there is only one independent claim at issue: claim 21. Asserted claims 22, 24, 25 and 27 are all dependent on claim 21 and cannot be infringed unless claim 21 is infringed. See Wahpeton Canvas, 870 F.2d at 1553. As the Court instructed the jury in this case, if any element of a claim is not infringed the claim itself cannot be infringed. (Tr. day 10, p. 116, line 24 — p. 118, line 5; Tr. day 11, p. 15, lines 5-8); see also Southwall Technologies, Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995); Mannesmann Demag Corp. v. Engineered Metal Products Co., 793 F.2d 1279, 1282 (Fed. Cir. 1986) ("Literal infringement requires that the accused device embody every element of the patent claim."). In order to arrive at the verdict that the EC-5000 infringes the Azema patent, then, the jury in this case must have found that the Nidek machine literally infringes every element of claim 21. Before the defendants can succeed in petitioning this Court to overturn that verdict, Nidek must show that there was not substantial evidence at trial upon which a reasonable jury could have properly found each and every element of claim 21 to be literally infringed. To put it another way, Nidek will succeed if it can select even one element from claim 21 and show that no reasonable jury could have found, based on the record before it, that the EC-5000 literally infringes that element.
In its renewed motion for JMOL, the defendants concentrate their argument for non-infringement of the Azema patent on elements (b), (c), and (d) of claim 21 — each of which the Court has construed to be a means-plus-function claim limitation. As has already been explained with regard to claim 1 of the Marshall patent, in order for Summit to prove literal infringement of these means-plus-function limitations, it had to establish at trial that (1) the EC-5000 contains a structure or structures that perform the identical functions to those recited in each means-plus-function limitation, and (2) said structures are either identical or equivalent to the corresponding structure or structures disclosed in the patent specification. See Kemco Sales, 208 F.3d at 1364.
The Court will first discuss the jury's decision with regard to element (c) of claim 21. The relevant portion of element (c) reads as follows:
(c) means for focusing said beam of light onto the anterior surface of a patient's cornea, whereby a light spot having an area a [sic] configuration is formed, the area of said light spot having a maximum area at least as large as the area of the cornea desired to be operated upon . . . (U.S. Patent No. 4,973,330, column 11, lines 26-31)
In construing this portion of element (c), the Court distilled the particular "function" that was called for by the language of the claim, and the precise "means" structure described in the patent specification for carrying out that function:
The "function" of this limitation is to focus the beam to direct a spot of light onto the front surface of the cornea. The area of this spot is at least as large as the area of the cornea one wishes to operate upon. The "means" structure described in the patent specification for performing this function is a lens.
At trial Nidek did not dispute that its EC-5000 contains a lens that focuses the laser beam to direct a spot of light onto the front surface of the cornea. What Nidek argued is that the EC-5000 directs no spot of light onto the cornea that is at least as large as the area of the cornea one wishes to operate upon. In other words, the defendants contend that the EC-5000 does not perform a function identical to that which is called for by the Court's construction of element (c), and that Summit failed to provide sufficient evidence to prove otherwise at trial. If Nidek is correct, and the trial record fails to provide "substantial evidence" sufficient for a reasonable jury to properly decide that the EC-5000 functions in a manner identical to the function recited in element (c) of claim 21, as construed, then this Court must overturn the jury's verdict that the Nidek machine infringes the Azema patent.
Trial Evidence Pertaining to Claim 21, Element (c) of the Azema Patent
In response to the defendants' motion for JMOL, Summit has presented to the Court evidence from trial which it believes supports three separate theories of infringement with regard to element (c) of claim 21. The Court finds that substantial evidence does not support any of these theories and that Nidek, thereby, infringes neither claim 21 nor the Azema patent as a whole. Summit's First Theory of Infringement
Because a ruling of non-infringement with regard to element (c) is all that is needed to find non-infringement of the entire claim, it is not necessary that the Court discuss any other of the elements at issue in claim 21.
The first theory argued by Summit is that Nidek infringes element (c) because at some of the EC-5000's smallest aperture sizes, it is possible for each individual laser pulse to be larger than the light spot produced on the cornea. Whenever this phenomenon occurs, Summit contends, the area of the light spot produced by the pulse is necessarily as large as the area of the cornea that is being ablated at that particular moment of the procedure. To say it another way, Summit asserts that the EC-5000 infringes element (c) whenever an individual pulse fills the entire aperture, and thereby produces a light spot on the cornea that is as large as the area being ablated at that instant. Because element (c), as construed, requires a light spot that is as big as "the area of the cornea one wishes to operate upon," however, the success of Summit's first theory of infringement depends entirely upon the premise that this "area" is dynamic, rather than static. In other words, the necessary premise underlying Summit's first theory is that the phrase "the area of the cornea one wishes to operate upon" refers to whatever area of the cornea is being exposed to the laser pulses at any given time during a procedure. This premise is not supported by substantial evidence.
Summit's first theory of infringement is gleaned from testimony given by Doctor Feld and Doctor Oesterlin. Doctor Feld testified that at some aperture sizes, "each of the individual pulses which is producing the composite pulse is larger than that little spot." (Tr. day 3, p. 75, lines 13-19 [Feld]). In addition, Doctor Oesterlin testified that "[f]or some aperture openings" individual pulses create light spots as big as the areas of cornea that can be ablated at those aperture sizes. (Tr. day 9, p. 17, lines 4-20 [Oesterlin]).
During the trial Summit called only one witness, Doctor Feld, to give testimony about what the area of the cornea one wishes to operate upon" actually means. This is what Doctor Feld said:
Q. . . . [W]e talked about the area of the cornea one wishes to operate upon. Does that area stay the same or does it change through the course of one of these procedures?
A. It changes as each different area of the cornea is approached. For example, at the beginning, a very wide spot might be used. And in that case, the area to be operated on is that entire wide spot. Then the spot will get smaller, and in that case, the area to be operated on will be the smallest region and then it will get smaller and smaller and smaller. And at each progressive step, the area to be operated on will be that area which is exposed to the cornea.
(Tr. day 3, p. 74, lines 21-25 — p. 75, lines 1-8 [Feld])
Clearly, Doctor Feld espouses the view that the "area of the cornea one wishes to operate upon" is an ever-changing area that must be defined numerous times over the course of a surgical procedure. Doctor Feld's opinion on this matter, however, cannot be relied upon.
Doctor Feld is a physicist, not a medical doctor. Cross examination of Doctor Feld revealed previous deposition testimony in which Feld declared that he would "defer to [Dr. Steinert] on this matter completely" because "[t]his is essentially a medical issue. . . ." (Tr. day 4, p. 21, lines 9-10 [Feld]). When Summit called Doctor Steinert to the stand, however, Summit's counsel did not ask for his opinion on the meaning of the terminology in question, despite the fact that Steinert is a medical doctor who has performed numerous laser vision surgeries. Defendants' exhibit 32 reveals, however, that Doctor Steinert does have an opinion on this matter which he previously gave in the context of another case. Doctor Steinert's position in that case directly contradicts the premise necessary to support Summit's first theory of infringement for element (c). In fact, Doctor Steinert's opinion was precisely in line with Nidek's position that "the area of the cornea one wishes to operate upon" must refer to the entire area of the cornea that is to be ablated during the course of a surgical procedure.
In his initial expert report for Summit Technology, Inc. v. Visx, Inc., CV 95-524 SLR (D. Del), Doctor Steinert explained that the Azema patent requires the function of "centering on the cornea a spot the size of the entire area of the cornea desired to be ablated and then varying the size and/or shape of that spot to achieve the desired differential ablation of corneal tissue." (Defendant's Exhibit 32, Initial Expert Report of Roger F. Steinert, M.D. Re: Infringement, p. 3) (emphasis added).
In addition to Doctor Feld's testimony, Summit cites an excerpted portion of Doctor Oesterlin's deposition testimony which Summit claims supports its premise regarding "the area of the cornea one wishes to operate upon." In his deposition, Doctor Oesterlin stated that "[t]he area of the cornea I wish to ablate at a certain time during the procedure is defined by the iris. . . . In order to achieve a differential ablation I have to change that area during the course of the procedure." (Tr. day 9, p. 16, lines 16-25 — p. 17, line 1 [Oesterlin]). This testimony, however, fails to provide support for Summit's position. Doctor Oesterlin spoke only of "the area of cornea I wish to ablate at a certain time during the procedure," and made no mention whatsoever of the area of the cornea he wishes to "operate upon." The terminology is clearly dissimilar, yet Summit tried to argue the terms are synonymous nevertheless. When counsel for the plaintiff attempted to equate the terms at trial, Doctor Oesterlin resisted unequivocally:
Q. Now, if we assume that the area you wish to operate upon is the area at each point in the procedure you wish to ablate, can you assume that?
A. No.
(Tr. day 9, p. 17, lines 4-7 [Oesterlin]) (emphasis added). Clearly, Doctor Oesterlin did not intend for his use of the phrase "area of the cornea I wish to ablate at a certain time during the procedure" to be made synonymous with "the area of the cornea one wishes to operate upon." It was only after the Court directed him to assume that the terms were synonymous for purposes of counsel's question, that Doctor Oesterlin gave testimony that was at all agreeable to Summit's position:
THE COURT: No, you have to assume it for the sake of the question.
THE WITNESS: Okay, I see.
BY MR. STONER:
Q. If you assume that the area you wish to operate upon in using, in performing these procedures changes during the course of the procedure; can you assume that?
A. Yes.
Q. Isn't it true that the EC-5000 does, individual pulses do create light spots as big as those areas for some aperture openings?
A. For some aperture openings, that is true.
(Tr. day 9, p. 17, lines 9-20 [Oesterlin]). Because Doctor Oesterlin clearly disagreed with the premise behind the last question in this sequence, his testimony cannot correctly be interpreted as supportive of Summit's position that "the area one wishes to operate upon" changes during the course of a procedure. Before being forced to assume a fact with which he did not agree, Doctor Oesterlin testified only that the area one wishes to ablate at a certain time during the procedure changes during the course of a surgery.
It is apparent that Summit has failed to introduce substantial evidence sufficient to support its first theory of infringement with regard to element (c) of claim 21. The trial record reveals that no reliable evidence was put before the jury that is adequate to support the necessary premise behind said theory. Specifically, the jury was given no reason to believe that whatever area of the cornea is being exposed to the laser light at any given moment during a procedure must be considered "the area of the cornea one wishes to operate upon." To the contrary, the defendants introduced competent testimony that the area desired to be operated upon is actually the entire or maximum area one wishes to ablate with the laser over the course of a procedure.
An example of such testimony was given by one of Nidek's experts, Dr. Peter Rapoza. Doctor Rapoza is a board certified ophthalmologist who specializes in refractive surgery and laser vision correction. At the time of his trial testimony, Doctor Rapoza had operated on close to 8,000 eyes for refractive surgical procedures. (See Tr. day 7, p. 35, lines 17-35 [Rapoza]). Doctor Rapoza testified that from the perspective of a refractive surgeon, it is not reasonable to consider each delivery of an individual excimer laser pulse, or even each delivery of a cluster of pulses, as constituting separate "operations" on the eye. (Tr. day 7, p. 80, lines 17-21 [Rapoza]). His opinion as to the meaning of the contested portion of the claim is as follows:
Q. Okay. Now from the perspective of a refractive surgeon, what in your professional opinion is the area to be operated on when doing a refractive procedure using an excimer laser?
A. It is the entire area that one wishes to ablate with the laser.
(Tr. day 7, p. 75, lines 14-19 [Rapoza])
To summarize, Summit has brought forth evidence sufficient to establish that at certain of the EC-5000's smallest aperture sizes, it is possible for a single laser pulse to fill the entire opening, thereby producing a light spot on the cornea that is as large as the areas being ablated at the instants where the aperture is sufficiently small. Nidek does not contest this. What Nidek does contest, however, and what Summit fails to establish, is that this evidence identically satisfies the functionality requirement in element (c) that said light spot be at least as large as "the area one wishes to operate upon." Summit fails because it produced no reliable evidence at trial that "the area one wishes to operate upon" may be defined as whatever area that is being ablated at any given time during a procedure. To make matters worse for Summit, while the trial record lacks evidence sufficient to support the necessary premise behind its theory, there is considerable evidence in the record to support Nidek's stance that "the area one wishes to operate upon" is the entire area to be ablated over the course of a procedure. In light of the totality of the evidence, then, this Court rules that Summit's first theory of infringement must fail for lack of substantial evidence, and that no reasonable jury could have properly found infringement pursuant to said theory.
Summit's Second Theory of Infringement
As an alternative to its first theory of infringement, Summit offers a second argument attempting to explain how the Nidek EC-5000 infringes element (c) of claim 21. Namely, Summit attests that "spatially combining" individual EC-5000 laser pulses results in the formation of a "composite beam" that is always as large or larger than the entire area that one wishes to operate upon. For purposes of arguing the merits of this second theory, Summit clearly appears willing to temporarily abandon the necessary premise behind its first theory. In its place, Summit simply accepts the fact that "the area of the cornea one wishes to operate upon" refers to the entire or maximum area to be ablated over the course of a procedure.
Said premise being that the claim construction's use of the phrase "the area one wishes to operate upon" refers to whatever portion of the cornea is being exposed to the laser pulses at any given time during a surgery, and is therefore a dynamic, ever-changing area that must be defined at numerous instants during the course of a procedure.
Summit offers three evidentiary bases which it claims support this second theory and amount to substantial evidence sufficient for the jury to have properly found infringement of element (c). First, Summit presents a portion of Doctor Feld's direct examination testimony where he declared that "the composite beam of the EC-5000, which is composed of the spatially combined pulses, all of them together, is always as large or larger than the area that is wished to be operated upon." (Tr. day 3, p. 75, line 25 — p. 76, lines 1-3 [Feld]) (emphasis added). Precisely what Doctor Feld meant when he used the terms "composite beam" and "spatially combined pulses" is not entirely clear from his testimony. Doctor Feld made no attempt to explain or present scientific evidence regarding how it is possible to "spatially combine" excimer laser pulses so as to form a "composite beam." What Doctor Feld's testimony appears to imply, however, is that individual EC-5000 pulses are somehow joined together to form a single beam which, in turn, shines a spot of light onto the cornea. This view cannot be supported by the trial evidence.
In direct opposition Doctor Feld's view is abundant and undisputed scientific evidence that it is physically impossible to combine excimer laser pulses in a manner where consecutive pulses are made to occupy the same space at the same time. In light of this overwhelming evidence, the terminology used by Doctor Feld simply cannot be understood to mean that multiple pulses are actually combined together to form one, single, coherent beam.
Indeed, Summit's own experts testified that combining individual pulses in time is physically impossible. For example, while giving testimony regarding Figure 3 in the Azema patent, Doctor Botineau, one of the inventors listed on the Azema patent, said:
Q. And so the technique that you show in Figure 3 is to have a series of pulses one at a time?
A. Yes. In a case there cannot be two pulses at the same time.
Q. Physically impossible with an excimer laser; right?
A. Yes, it doesn't make much sense.
(Tr. day 2, p. 105, lines 8-13 [Botineau]) (emphasis added)
Similarly, Doctor Feld testified as follows:
Q. Each pulse in the Nidek system that strikes the eye does so as a separate event spaced in time; is that correct?
A. That's correct.
(Tr. day 3, p. 120, lines 4-7 [Feld]) (emphasis added)
And Doctor Raven, another of Summit's experts, testified to the following on cross examination:
Q. The pulses can come out of the laser a little faster or a little slower but there is always a space in time between the laser pulses; correct?
A. Yes, there is.
Q. And the energy of one pulse is not combined with the energy of a second pulse to hit the surface; correct?
A. Not at the same time.
(Tr. day 2, p. 67, lines 10-16 [Raven]) (emphasis added)
The next piece of evidence upon which Summit relies to support its second theory of infringement is a diagram, entitled "Scan Rotate," which was taken from one of Nidek's FDA submissions. This diagram, which can be found at N.C. 00630338 of Joint Exhibit 11, illustrates the EC-5000's scanning mechanism and shows a series of rotated "scans" across various aperture sizes. Each "scan" consists of ten individual laser pulses, the boundaries of which are indicated in the illustration as broken lines set parallel to one another.
The diagram repeatedly illustrates only eight pulses rather than the full ten which make up a complete "scan."
During direct examination of Doctor Feld, counsel for Summit asked Feld to explain this "Scan Rotate" diagram. In the context of the Nidek illustration, Doctor Feld again chose to use the term "composite beam," and he even added a new term, "composite pulse." Specifically, he described each of the ten pulse "scans" depicted in the diagram as being a "composite pulse." (Tr. day 3, p. 76, lines 11-12 [Feld]). Doctor Feld further pointed out with regard to the Nidek diagram, that even when the EC-5000 aperture is at its largest dimension, the so-called "composite beam" always fills the entire opening. (Tr. day 3, p. 76, lines 24-25 — p. 77, lines 1-3 [Feld]).
Doctor Feld's use of this "composite beam" phraseology in the context of the Nidek diagram, once again does nothing to explicate precisely how it would be physically possible for such a "composite beam" to be formed. No matter what terminology Doctor Feld elected to use to describe the contents of the "Scan Rotate" diagram, said diagram simply does not stand for the proposition that individual pulses may be physically combined in time to form one beam. Rather, it illustrates only the fact that the sum of the areas of the cornea covered by all of the individual pulses in a "scan" will always be at least as large as the entire area to be operated upon.
In light of the overwhelming scientific evidence, the Court finds that it would be entirely unreasonable to believe that a so-called "composite beam" of "spatially combined pulses" refers to an actual, physical laser beam. Instead, this "composite beam," as the term has been used in this case, can only be comprehended as a symbolic representation of the total area that ten separate beams (pulses) occupy over the course of a very short period of time (i.e., one EC-5000 "scan").
At trial, Summit pointed out that Nidek's own FDA submissions make a passing reference to "pulses [that are] combined [in order to achieve] a uniform depth of ablation." (See Joint Exhibit 10 at NTI-FDA 00011205) (emphasis added). Once again, however, given the evidence introduced at trial, it would not be possible for a reasonable jury to understand this to mean that pulses may be physically combined to form a single beam.
The third and final evidentiary basis set forth by Summit to support its second theory of infringement, is an excerpted portion of Doctor Oesterlin's cross-examination testimony:
Q. Now, can we make that assumption if we assume that the pulses in a scan are combined together to form a uniform beam; right?
A. I already said yesterday that this is not possible and what is combined is the effect of the pulses within one scan.
Q. It's true that in the course of a scan, even at the maximum area you wish to operate upon, that entire area is covered by pulses within a quarter of a second; right?
A. By individual pulses, yes.
(Tr. day 9, p. 20, lines 15-24 [Oesterlin]) (emphasis added).
Here, Doctor Oesterlin most certainly admits that a scan of ten pulses occurs within a fraction of a second. His testimony, however, does nothing to advance Summit's theory that pulses can be "combined" to form one beam. The only things that can be "combined," according to Doctor Oesterlin, are the effects of the pulses, not the pulses themselves. Furthermore, Doctor Oesterlin testifies clearly that the amount of time that separates the individual pulses in a scan (even if it is an extremely short amount of time) is entirely immaterial. No matter how quickly the individual pulses cover the maximum area one wishes to operate upon, the pulses can never be made into one, physical beam. As such, this portion of Doctor Oesterlin's testimony provides no evidence upon which a finding of infringement may be properly based.
The three evidentiary bases offered by Summit in support of its second theory of infringement are not substantial evidence upon which a reasonable jury may find infringement of element (c). Neither the limitation itself, nor the Court's construction of it, make any mention of a "composite" beam that shines a "composite" spot of light onto the cornea. Instead, the Court, in its claim construction order, has clearly stated that "[t]he `function' of this limitation is to focus the beam to direct a spot of light onto the front surface of the cornea." And that "[t]he area of this spot is at least as large as the area of the cornea one wishes to operate upon." (emphasis added). Where Summit falls short of proving infringement, then, is its failure to provide any evidence that the EC-5000 produces a "beam" that is large enough to create a "spot" of light on the cornea that is as big as the area one wishes to operate upon. The trial record, taken as a whole, indicates that Summit's evidence is sufficient to establish only one fact: that the area covered by a scan of ten individual EC-5000 pulses is always as large as the entire area one wishes to operate upon. Summit has failed to produce evidence to establish that the ten individual pulses which cover this area comprise a "beam," rather than ten beams. Nor has the plaintiff shown that ten individual pulses are capable of creating "a spot" of light, rather than ten spots. Clearly, Summit's evidence provides an insufficient basis for the jury to find that the EC-5000 identically satisfies the functionality requirement of element (c) as it has been construed, and is not substantial evidence upon which a reasonable jury could find literal infringement.
Summit's Third Theory of Infringement
The third and final theory posed by Summit as to how the Nidek EC-5000 infringes element (c) of claim 21, revolves entirely around the meaning of the term "large-area ablation." Essentially, Summit theorizes that because Nidek itself has referred to its EC-5000 device as being a "large area ablation" system, then the EC-5000 must, by definition, be able to cover the entire area one wishes to ablate with a single pulse of the laser. As was the case with Summit's second theory, for purposes of its final theory of infringement Summit again appears willing to concede that "the area of the cornea one wishes to operate upon," refers to the entire area to be ablated over the course of a procedure. In addition, Summit's third theory does not require one to accept Summit's "composite beam" hypothesis. To support its final theory of infringement, Summit cites only the following excerpted portions of testimony given by Mr. Kan Ohtsuki, a Nidek employee:
Q. Well, a system where you cover the entire area that you wish to ablate with one pulse of the laser is called a wide-area ablation system, right?
A. Yes. It is my understanding that that is the general way it is referred to.
Q. That kind of system is also called a large-area ablation system, is it not?
A. Yes. I think it is sometimes called that.
Q. Nidek's EC-5000 laser is a wide- or large-area ablation system, is it not?
A. Given the meaning of large-area ablation, and as you, Mr. Stoner, have just used it, the EC-5000 does not correspond to that.
(Tr. day 5, p. 86, lines 4-16 [Ohtsuki])
Mr. Ohtsuki was clearly objecting to the manner in which the EC-5000 was being characterized by Summit's counsel. In response, Summit's counsel confronted Mr. Ohtsuki with a Nidek document which used the words "large-area ablation" to describe a 1991 prototype predecessor to today's EC-5000.
Q. And you say in this document, Joint Exhibit 13, that in 1990, there was an evolution of the R D project plan to include large-area ablation?
A. Yes.
Q. That was true, right?
A. Yes.
Q. In 1991, according to Joint Exhibit 13, you built a prototype for large-area ablation?
A. Yes.
Q. This was the prototype that became the EC-5000, right?
A. Yes.
(Tr. day 5, p. 87, lines 19-25 — p. 88, lines 1-4 [Ohtsuki])
Mr. Ohtsuki does not deny that Nidek has referred to the prototype which became the modern EC-5000 as a machine that performed "large-area ablation." From this fact alone, however, it does not necessarily follow that the EC-5000 functions in a manner identical to that which is called for by element (c). Noticeably absent from Summit's argument is any documentary or testimonial evidence clearly establishing that the defining characteristic of "large-area ablation" is a machine's ability to function in a manner whereby one pulse from the laser covers the entire area to be ablated over the course of a procedure. In other words, Summit's evidence does not address, and fails to eliminate the possibility that a machine may indeed perform "large-area ablation" without also being capable of having one pulse cover the entire area desired to be operated upon. This possibility that "large-area ablation" may take on more than the one meaning that Summit was trying to assign to it, was made abundantly clear when Doctor Ohtsuki testified to the following:
Q. And it was a large-area ablation system, was it not?
A. What is meant by a large-area ablation here is that compared with the system that we had had until that time, which we referred to as the linear cut system that worked on a narrow area or small area and, in particular, illuminated a small area.THE COURT: Keep your voice up.
A. Compared to the system we used previously that we referred to as the linear cut system, which illuminated a small area, this system illuminated a wider area. In particular, this was a system which moved from addressing RK surgery to addressing PRK surgery.
(Tr. day 5, p. 88, lines 5-16 [Ohtsuki])
Given the apparent uncertainty and somewhat inconsistent testimony surrounding precisely how "large-area ablation" should be defined, the Court, for purposes of Nidek's motion for JMOL, considers the evidence in a light most favorable to the non-mover and therefore resolves the ambiguity in favor of Summit. See, e.g., Forest Laboratories, 239 F.3d at 1309. The Court infers, then, that "large-area ablation" requires the function of a single pulse covering the entire or maximum area to be ablated during the course of a procedure and thereby producing a spot of light on the cornea that is at least as large as the area one wishes to operate upon. Even so, however, the fact that Nidek merely used the term "large-area ablation" to describe a function of its machine, does not, on its own, condemn the EC-5000 to the status of an infringing device. The one and only way Summit could prove literal infringement at trial was by showing that the allegedly infringing EC-5000 contains a structure that actually performs the identical function to that recited in element (c), and that structure is either identical or equivalent to the corresponding structure or structures disclosed in the patent specification. See Kemco Sales, 208 F.3d at 1364. As has already been discussed, though, the overwhelming and undisputed scientific evidence introduced at trial clearly establishes that the Nidek EC-5000 simply does not produce a single pulse that covers the entire area to be operated upon, and therefore does not perform a function identical to that recited in element (c). The question as to whether Nidek used the "large-area ablation" terminology in an erroneous or even fallacious fashion in a piece of descriptive literature available to the public, therefore, is inapposite on the issue of literal infringement and is not substantial evidence upon which a reasonable jury could find element (c) literally infringed by Nidek.
Conclusion
Summit has failed to introduce substantial evidence sufficient for a reasonable jury to find that the Nidek EC-5000 literally infringes either the Marshall or Azema patents. Defendants' renewed motion for judgment as a matter of law is hereby granted with respect to both patents at issue. The jury's verdict is vacated and judgment is for the defendants.
SO ORDERED.