Opinion ID: 785735
Heading Depth: 3
Heading Rank: 1

Heading: The Marshall '093 Patent

Text: 33 The parties dispute whether substantial evidence supports the jury's finding that Nidek infringed the beam dimension control means limitation of the Marshall '093 patent. The district court construed the beam dimension control means limitation as a means-plus-function limitation subject to 35 U.S.C. § 112, ¶ 6. The district court's claim construction stated in relevant part: 34 The function of this limitation is, using optical component(s) in the path of the laser beam, to vary an area on the surface to which 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. Pulses delivered to the surface have substantially the same energy per unit area if they each ablate approximately the same depth of material. 35 Claim Construction Order, slip op. at 2. The district court further clarified that each claim [of the Marshall '093 patent] requires that as the area of the 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.' JMOL Order, 2002 WL 31844693, at . To establish infringement under the district court's claim construction, Summit was required to prove that each pulse delivered to the surface in Nidek's EC-5000 device ablated approximately the same depth of corneal material. 36 The district court entered judgment as a matter of law based on Summit's failure to present evidence that the pulses in Nidek's system ablated approximately the same depth of corneal material as the aperture size varied. Summit argues the district court's judgment was incorrect because it presented substantial evidence of Nidek's infringement in the form of testimony by its expert Dr. Feld, admissions by Nidek's experts, and Nidek's statements to the Food and Drug Administration (FDA) concerning its EC-5000 Excimer Laser System. Nidek argues the district court properly entered a judgment of non-infringement because Summit failed to present substantial evidence of infringement. Nidek also argues in the alternative that it does not infringe because the individual pulses do not ablate approximately the same depth of corneal tissue because the Gaussian-shaped energy distributions of the pulses ablate a non-uniform depth across each laser pulse. We agree with the district court that judgment as a matter of law of non-infringement is in order, not on the grounds cited by the district court, but on the basis of Nidek's alternative argument. 37 Because the evidence at trial indicated that the individual laser pulses delivered to the surface of the eye by Nidek's EC-5000 device have Gaussian- or bell-shaped energy distributions and thus ablate non-uniform depths of corneal tissue, rather than ablating approximately the same depth of corneal tissue as required by the district court's claim construction, we conclude that Summit failed in its burden of proving literal infringement of the Marshall '093 patent. 38 Nidek correctly points out that Summit failed to produce any data from the accused EC-5000 or any other evidence to establish that the individual pulses delivered to the corneal surface ablate substantially the same depth of corneal material. To the contrary, the evidence presented at trial establishes that the pulses delivered to the surface do not have substantially the same energy per unit area, but instead have a Gaussian-shaped energy density distribution. 39 Nidek's statements to the FDA concerning the operation of its EC-5000 establish that the individual pulses are Gaussian-shaped. EC-5000 Excimer Laser System, Response to FDA Questions of July 20, 1994 ( FDA Response ). In its FDA submissions, Nidek stated in relevant part: 40 In practice, the laser pulse has a rectangular cross section [which] is reduced to a maximum size of 2 mm × 7.5 mm at the surface of the cornea. Because the pulse width is much less than the scanning width and because the energy distribution of the pulse is Gaussian across the pulse width, each pulse ablates an area of the cornea which is determined by the ablation threshold of the cornea (see Appendix 1, Figures 6-8). Ten sequential pulses are emitted as the beam axis is scanned across the cornea in a direction perpendicular to the long dimension of the pulse cross section. Scan timing and pulse rate is set so that successive pulses overlap along the long direction of the rectangle so as to give uniform ablation depth of the corneal surface. 41 FDA Response at 1 (emphasis added). 42 On cross-examination, Summit's expert Dr. Feld admitted that the depth of ablation for individual pulses was not substantially the same, but instead created Gaussian — or crater — shaped ablation profiles: 43 Q. Is it your testimony that Nidek told the FDA that the pulse on the top will create an ablation in the corneal tissue that looks like the crater on the bottom? 44 A. That is absolutely correct what Nidek told the FDA. I'm just clarifying your question. 45 Q. Is this crater on the bottom ... the same crater of uniform depth that Marshall produces? 46 A. No. 47 Q. It's not, is it? It's much shallower, is it not, in the tapered portion than at the deepest part, right? Correct? 48 A. It looks like Marshall is on the one side, then it tapers off on the other side. 49 Trial Tr. day 4, p. 93, l. 17 — p. 94, l. 3 (emphases added). 50 Nidek's defense exhibits further emphasize that the energy densities delivered to the cornea, and hence ablation profiles, were not uniform and did not ablate approximately the same depth of material. Based on these exhibits, Dr. Feld admitted on cross-examination that the individual pulses delivered to the surface ablated non-uniform depths of corneal material. Trial Tr. day 4, p. 110, ll. 10-19 (Feld testimony) (We should explain [that in Defendant's Exhibit 138 diagram displaying energy densities of EC-5000 pulses] the different colors here correspond to different ablation depths.... Here you can see, [at] the steepest part, the most fluence of this pulse is in the center, and it falls off at the edges, according to this color coded manner....). 51 Relying on the same set of Nidek defense exhibits depicting the energy densities of EC-5000 pulses about which Dr. Feld was questioned, Nidek's expert Dr. Oesterlin also agreed that the energy per unit area, and hence the depth of ablation, was not substantially the same throughout the pulse: 52 Q. Let's look at Defendant's Exhibit 134. Let's explain what this is and contrast this to the prior exhibit? 53 A. Yes. This is a pulse where the iris diaphragm is wide open now, so the circle is much larger. Much more of the pulse can pass through this iris diaphragm opening. 54 We see again the center and both rings pass through, but the amount of or the light which passes through this aperture is not constant in energy per unit area. 55 Q. And does a pulse as illustrated here in Exhibit 134 have substantially the same energy per unit area? 56 A. No. It does not. 57 Q. Now, Doctor, if a pulse satisfied the requirements of the Marshall patent Claim 1, what color would we see there? 58 A. We would see the entire circle in yellow. 59 Q. What is the significance of seeing one color? A. The significance of seeing one color is that it is [a, sic] homogenous energy distribution. The pulse has everywhere the same energy intensity. 60 Trial Tr. day 8, p. 102, l. 14 — p. 103, l. 6 (emphases added). 61 Summit argues that Nidek's alternative ground for affirming the district court's judgment as a matter of law is flawed because it relates to the energy distribution instead of the energy per unit area specified in the claim. Summit failed to present any evidence at trial to show a meaningful difference between energy density distributions and energy per unit area. Summit's only evidence that it presented at trial in support of this argument is the cross-examination testimony of Nidek's expert Dr. Oesterlin to the effect that the words profile and energy distribution do not appear in the district court's construction of claim 15 of the Marshall '093 patent. See Trial Tr. day 8, p. 134, l. 21 — p. 136, l. 5. Critically, Summit ignores the second part of the district court's construction of claim 1, which requires that the pulses delivered to the surface of the eye ablate approximately the same depth of material, and failed to present evidence from which a reasonable juror could conclude that each laser pulse ablates a substantially uniform depth of material across the pulse. 62 Based on the foregoing, we conclude that Summit failed to present more than a mere scintilla of evidence that the individual pulses in Nidek's EC-5000 result in a substantially uniform depth of ablation across each pulse, and thus that Nidek infringed the Marshall '093 patent. The district court's grant of judgment as a matter of law of non-infringement of the Marshall '093 patent is affirmed.