Opinion ID: 785735
Heading Depth: 3
Heading Rank: 2

Heading: The Azema '330 Patent

Text: 63 The parties dispute whether substantial evidence supports the jury's finding that Nidek infringed the means for focusing limitation of claim 21 of the Azema '330 patent. Claim 21 states in relevant part: 64 (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 configuration [sic] 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.... 65 Azema '330 patent, col. 11, ll. 28-33. In construing the disputed means for focusing limitation of the Azema '330 patent as a means-plus-function limitation subject to 35 U.S.C. § 112, ¶ 6, the district court stated in relevant part: 66 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 the 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. 67 Claim Construction Order, slip op. at 4. 68 It was undisputed at trial that Nidek's EC-5000 has a lens that focuses the laser beam and directs a spot of light onto the front surface of the cornea. JMOL Order, 2002 WL 31844693, at . The parties principally disputed whether Nidek's accused product satisfies the district court's requirement that [t]he area of the spot is at least as large as the area of the cornea one wishes to operate upon. Both in opposition to Nidek's motion for judgment as a matter of law and on appeal, Summit argues it presented evidence of Nidek's infringement under three separate theories: (1) that the area of the cornea one wishes to operate upon is dynamic and changes throughout the procedure; (2) even assuming the area of the cornea is static, individual laser pulses are physically combined to form a composite pulse which covers the entire area of the cornea; and (3) also assuming the area of the cornea is static, Nidek's description of the accused device as a large-area or wide-area ablation system in its product literature implies that the device necessarily infringes. Specifically, Summit points to testimony by its expert Dr. Feld, admissions by Nidek's experts, Nidek's statements to the FDA, and Nidek's public statements, as evidence of infringement under its theories sufficient to support the jury's verdict of infringement. Nidek responds that the district court properly found that no substantial evidence supports the jury's finding that Nidek literally infringed the Azema '330 patent.
69 Under its first theory, Summit argues that Nidek infringed the means for focusing limitation because at small aperture sizes, it is possible for each individual laser pulse to be larger than the light spot produced on the cornea. JMOL Order, 2002 WL 31844693, at . Thus, whenever this occurs, the light spot produced by the pulse is as large as the area that is being ablated at that particular moment of the procedure. Id. This infringement theory is necessarily premised on the assumption that the area of the cornea one wishes to operate upon in the district court's claim construction is dynamic, and encompasses the specific area of the cornea that is ablated at any given time during a procedure. Id. In support of this theory, Summit presented direct testimony by Dr. Feld that the area of operation progressively changes throughout the course of the procedure. Trial Tr. day 3, p. 74, l. 21 — p. 75, l. 8. In addition, Summit argues that admissions by Nidek's experts Dr. Oesterlin and Dr. Rapoza are consistent with Dr. Feld's testimony and provide further evidence of Nidek's infringement. 70 The district court's claim construction highlighted the portion of the claim that recited the function of the means for focusing limitation. Both the claim construction and the claim language were submitted to the jury. Trial Tr. day 11, p. 112, l. 16 — p. 113, l. 3. According to the claim construction and the claim language, the function of the means for focusing is to focus a beam of light so as to direct a spot of light onto the front surface of the cornea. The claim construction recites that the area of the spot of light is at least as large as the area of the cornea one wishes to operate upon. The claim language itself states that the area of said light spot ha[s] a maximum area at least as large as the area of the cornea desired to be operated upon. Azema '330 patent, col. 11, ll. 31-33 (emphasis added). While the district court's claim construction was not explicit, the claim language itself is clear that the area of the cornea desired to be operated upon is the frame of reference for determining the maximum area of the light spot. This has nothing to do with the extent of ablation produced by an impinging light spot at any one time during a surgical procedure. Thus, the testimony directed to the variation in character of the light spot as somehow related to the area of the cornea desired to be operated upon is misplaced. 71 The proper infringement inquiry is simply whether the accused device contains a beam of light that is focused by a lens into a spot of light on the cornea, the spot of light having a maximum area at least as large as the area of the cornea to be reshaped by the surgical procedure. The claim language the area of the cornea desired to be operated upon is the entire area of the cornea to be treated during the course of the laser eye surgical operation, not the area undergoing ablation at any one time, as Summit argues. 72 Summit's argument is premised on the area of the cornea desired to be operated upon being dynamic. That premise is misplaced. It is irrelevant whether the light beam is larger than the light spot produced on the cornea at certain points of the procedure. Thus, Dr. Feld's testimony that the area of operation is dynamic is not sufficient evidence to support the jury's verdict that Nidek infringed the Azema '330 patent, nor are the alleged admissions by Nidek's experts Dr. Oesterlin and Dr. Sayano to that effect.
73 Summit contends that even assuming the area of the cornea one wishes to operate upon is static and covers the entire area one wishes to operate upon throughout the procedure, Nidek's FDA submissions establish infringement. Specifically, Summit relies on Nidek's statement in a copy of a patent application submitted to the FDA that during scanning, individual [laser] pulses are combined and a uniform depth of ablation is achieved. Essentially, Summit argues that Nidek's device literally infringes because in the accused device, a series of pulses across the cornea are physically combined and cover the entire area of the cornea one wishes to operate upon. But the claim language requires the formation of  a light spot ... 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. Azema '330 patent, col. 11, ll. 29-33 (emphasis added). Thus, Summit must establish that Nidek's device is capable of creating a single light spot, the maximum area of which is at least as large as the area of the cornea desired to be operated upon. 74 The FDA submission and all of Summit's proffered trial testimony concern the net effect of individual and separate laser pulses in an EC-5000 scan to achieve uniform ablation, not the physical combination that Summit urges. None of the witnesses testified that the individual laser pulses in a scan were physically combined to form a single spot of light required by the claim language and the district court's claim construction. At best, the testimony established that the net ablation effect of the individual light spots of each laser pulse covered the entire area of the cornea one wishes to operate upon. 75 Summit cites to Dr. Ohtsuki's cross-examination to support its assertion that individual laser pulses are physically combined, but his testimony reveals otherwise: 76 Q. And it's correct that in the EC-5000, the pulses are combined, isn't it? 77 A. The problem is in the word combined, I believe. There are ten pulses in a single scan. The result of those pulses is that a uniform depth is achieved, and that was the meaning in which I answered that question, I believe. 78 Q. Well, in the EC-5000, those ten pulses in a scan, when you're treating the maximum area you want to ablate, are combined together within a quarter second to cover the entire maximum area you wish to ablate, right? 79 A. As I said before, with respect to the ten pulses that are illuminated on the cornea, it is the result which is the combination, not the pulses of light which are the combination. 80 Trial Tr. day 5, p. 93, l. 22 — p. 94, l. 10 (emphasis added). 81 Summit's expert, Dr. Feld, asserted on direct examination that the pulses were physically, or spatially, combined: 82 A.... In addition, 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. 83 Trial Tr. day 3, p. 75, l. 25 — p. 76, l. 3. However, Dr. Feld directly contradicted himself, twice admitting the exact opposite on cross-examination: 84 Q. Now, in the Nidek system, in the Nidek system each pulse is emitted one at a time; correct? 85 A. That's correct. 86 Q. A pulse is emitted and then it strikes the eye? 87 A. Yes. 88 Q. Second pulse is emitted and strikes the eye? 89 A. Yes. 90 Q. They're separate events; correct? 91 A. Yes. 92 Trial Tr. day 3, p. 119, ll. 17-25. 93 Q. And isn't it true, ... Professor Feld, that in the Nidek system no two pulses ever reach the cornea at the same time? 94 A. That's correct. 95 Trial Tr. day 3, p. 126, ll. 22-25. Summit's assertion of a scientifically flawed premise of the physical combination of individual laser pulses cannot be a basis for finding infringement. Because all of the witnesses agreed or admitted at trial that such physical combinations of separate laser pulses were technologically impossible, such testimony cannot provide the more than a mere scintilla of evidence needed to support the jury's finding of infringement of the Azema '330 patent.
96 Summit argues that Nidek's public statements contained in its product literature that its EC-5000 was a wide-area ablation system are tantamount to an admission of infringement of the Azema '330 patent. Essentially, Summit contends that Nidek's references to its accused EC-5000 as a large-area or wide-area ablation system, coupled with Dr. Oesterlin's testimony, inherently indicate that the EC-5000 is able to cover the entire area of the cornea one wishes to operate upon with a single pulse of a laser. JMOL Order, 2002 WL 31844693, at . However, Dr. Oesterlin's cross-examination reveals the opposite conclusion: 97 Q. But your understanding is that wide-area ablation means a single pulse of the laser will cover the entire maximum area you wish to operate upon with the laser; right? 98 A. That's right. 99 Q. And you believe that the Marshall patent and the Azema patent are wide-area ablation systems; right? 100 A. Yes. 101 Q. And the [Nidek] EC-5000 is, too, is it not? 102 A. No. 103    104 Q. If we assume that the EC-5000 is a large area ablation system with the definition you have for that term, that the EC-5000 must create responsive light on the eye as big as the entire area, maximum area you wish to ablate; right? 105 A. If you make this assumption, yes. 106 Q. Now, we can make that assumption if we assume that the pulses in a scan are combined together to form a unified beam; right? 107 A. I already said yesterday that this is not possible and what is combined is the effect of the pulses within one scan. 108 Trial Tr. day 9, p. 19, l. 14 — p. 20, l. 20 (emphases added). Although Dr. Oesterlin's definition of wide-area ablation systems was consistent with the district court's construction, Trial Tr. day 9, p. 19, ll. 14-17, he explicitly stated that Nidek's EC-5000 was not a wide-area ablation system within that definition. Instead, as discussed above, Dr. Oesterlin emphasized that it was physically impossible to combine the light spots from the individual laser pulses. Trial Tr. day 9, p. 20, ll. 15-20. Because the area of the light spots from the individual laser pulses did not cover the entire area one wishes to operate upon, the evidence does not support a conclusion of infringement by the EC-5000 under the district court's construction. 109 We have considered the remainder of Summit's multiplicity of arguments based on various snippets of evidence, and conclude that individually and collectively these arguments fail to overcome the evidentiary shortcomings of its infringement case. 110 Because Summit failed to present more than a mere scintilla of evidence that Nidek infringed the Azema '330 patent, the district court's grant of judgment as a matter of law of non-infringement is affirmed. 3. Nidek's Alternative Argument 111 As an alternative basis to support the judgment of non-infringement of the Marshall '093 patent, Nidek challenges some of the district court's claim construction rulings. In light of our affirmance of the district court's judgment, Nidek's alternative argument is moot and need not be addressed.