Opinion ID: 209426
Heading Depth: 3
Heading Rank: 1

Heading: Commercial Device

Text: We first address whether the district court properly concluded, on summary judgment, that the Commercial Device did not infringe the ’802, ’193, and ’575 patents. a. Claim Construction of “selected higher and lower pressure magnitudes” Respironics challenges the district court’s construction of the term “selected higher and lower pressure magnitudes” in method claims 3 and 24 of the ’802 patent and method claims 9, 44, and 53 of the ’193 patent. The district court construed this term identically for all claims, and the parties do not urge different constructions for different claims. Claim 3 of the ’802 patent recites, with disputed term emphasized: A method of medical treatment for a patient comprising the steps of: [1] providing a flow of breathing gas from a source for delivery to the airway of such a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure; [2] continually detecting the instantaneous flow rate of said breathing gas flowing between said source and the airway of such a patient; [3] continually processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of breathing gas flowing between said source and said patient; and [4] utilizing said instantaneous flow rate and said reference indicia to select one of said higher and said lower pressure magnitudes for said flow of breathing gas to be applied in the airway of such a patient. (bracketed numbers added). The district court construed the term “selected higher and lower pressure magnitudes” in step one to require the pressure magnitudes to be “chosen prior to 2008-1164, -1193 5 operation of the computer circuitry that is used to determine whether the patient is inhaling or exhaling.” Claim Construction Order at 16 (emphasis added). Respironics argues that this construction impermissibly imports a temporal limitation into the claims. It argues that the method steps are not set forth in any chronological sequence and, accordingly, the pressure magnitudes need not be selected at any particular time in the sequence. Invacare defends the district court’s construction, arguing that the word “select” appears twice in the claims: in the past tense “selected” in step one, and in the present tense “to select” in step four. These two occurences of the word “select,” coupled with step four’s refererence back to “said” magnitudes in step one, convinces Invacare that the magnitudes in step one are selected before any of steps two, three, or four are performed. The claim language itself provides little insight as to when the pressure magnitudes in step one are “selected.” Because steps two and three must be performed “continually,” it cannot be said that the claim language itself requires all steps to be performed in the order written. Also, the mere fact that step four refers back to “said higher and said lower pressure magnitudes” of step one does not, as a rule, require step one to be performed before step four. Indeed, in Interactive Gift Express, we held that step one of a method claim can be performed after step four, even though step four referred to “the catalog code” introduced in step one. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1328 (Fed. Cir. 2001) (emphasis added); id. at 1343 (“[T]here is no reason why step one[ ] . . . must occur before step four[ ] . . . .). Thus, in a method claim, a step that recites “said” or “the,” referring to an earlier object, does not always have to be performed after the step that first introduces the object. 2008-1164, -1193 6 We turn then to the specification, which we have called “‘the single best guide to the meaning of a disputed term.’” Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). In this case, the specification discloses only one way to select the higher and lower pressure magnitudes: via pressure adjustment controls (labeled “90” and “92”), which are depicted as a pair of dials in Figure 4, reproduced below. These dials, according to the specification, are used “for setting the respective [higher] IPAP and [lower] EPAP pressure levels.” ’802 patent col.13 ll.30-31. Throughout the specification, the pressure magnitudes are referred to as being “predetermined,” id. col.2 l.68-col.3 l.1, col.7 l.40, or “preselected,” id. col.3 l.27. See also ’194 patent col.3 ll.3-4, l.30. When pressed at oral argument to identify an embodiment in the specification where the pressure magnitudes are not preselected, counsel for Respironics was unable to do so. Oral Arg. at 5:35-6:10, available at http://oralarguments.cafc.uscourts.gov/mp3/2008-1164.mp3. Similarly, the district court found, and we agree, that “[t]here is no indication in the patents that the lower pressure magnitude can somehow be changed breath by breath.” Claim Construction Order at 2008-1164, -1193 7 19. The preselection of higher and lower pressure magnitudes is not merely a preferred embodiment; it is the patents’ only embodiment. The prosecution history also supports the district court’s construction. As originally filed, claims 3 and 24 of the ’802 patent used the word “alternately” in place of the now-disputed word “selected.” In response to an obviousness rejection, Respironics amended the term to its current form and carried it over to the claims of the ’193 patent. J.A. 935, 939. Respironics offers no explanation for this amendment. But, to whatever extent the word “alternately” might have permitted selection of pressure magnitudes on a breath-by-breath basis, a capability nowhere disclosed in the patents, Respironics’s decision to replace “alternately” with “selected” forecloses the broader construction. Thus, we conclude that the district court correctly construed the term “selected higher and lower pressure magnitudes” to require the pressure magnitudes to be chosen prior to operation of the computer circuitry that is used to determine whether the patient is inhaling or exhaling. See Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed. Cir. 1999) (“Although not every process claim is limited to the performance of its steps in the order written, the language of the claim, the specification and the prosecution history support a limiting construction in this case.”). b. Infringement of ’802 and ’193 Patents We also conclude that that district court correctly determined that the Commercial Device does not infringe the ’802 and ’193 patents under the district court’s proper claim construction. As previously discussed, the claims require both higher and lower pressure magnitudes to be selected at the outset of operation. The Commercial Device, however, preselects only the higher pressure magnitude when operated under 2008-1164, -1193 8 normal conditions, not the lower magnitude. Respironics, 511 F. Supp. 2d at 596 (quoting Respironics’s expert as admitting that “the magnitude of unloading is a function of the [SoftX] setting . . . and peak inspiratory flow of the preceding inspiration (patientdetermined quantity)”). Because the Commercial Device does not perform every step of the asserted claims, we agree with the district court that the Commercial Device does not infringe these patents. Respironics argues, alternatively, that operating the Commercial Device in socalled “Standby Mode” might still infringe the ’802 and ’193 patents. Although the district court’s opinion did not expressly address this argument, we conclude that Respironics’s evidence failed to create a genuine issue of material fact sufficient to defeat the grant of summary judgment of noninfringement. Respironics relies on the Supplemental Mascara Declaration for the assertion that the ΔV variable in the Unloading Equation is given a predetermined value in Standby Mode, which is then used to preselect the lower pressure magnitude before the device detects whether the patient is inhaling or exhaling, as required by the claims. This statement is directly belied by Respironics’s own brief, which expressly defines the ΔV variable as “the change in valve position defined by (Peak – Median) for the inhalation of the previous breathing cycle.” Appellant’s Br. 14 (emphasis added). Because ΔV presupposes the detection of a previous breathing cycle, this operation cannot infringe. A similarly noninfringing definition of ΔV is found in the computer code cited in the Supplemental Mascara Declaration. See J.A. 1985 (defining “ΔV = 10 (‘valve_change’ initial value)”) (citing J.A. 4477 (“The valve_change value is the amount of movement the valve has m[a]de from it[s] average position between breaths.”) (emphasis added)). Because 2008-1164, -1193 9 there is no genuine issue of material fact that ΔV requires at least one prior breath to have been detected, operating the Commercial Device in Standby Mode does not infringe as a matter of law. Accordingly, we affirm the judgment of noninfringement of the ’802 and ’193 patents. c. Claim Construction of “shape” Respironics challenges the district court’s construction of the word “shape” in claims 21 and 43 of the ’575 patent. That word is used in the following phrase: “a shape of said predetermined pressure profile is set independent of any monitored respiratory characteristics of such a patient.” (emphasis added). The district court construed “shape” to mean “magnitude and duration.” Claim Construction Order at 26. We agree with Respironics that this construction is unduly narrow. As the intrinsic record makes clear, a pressure profile is defined not only by its magnitude and duration, but also by its shape, which is a different characteristic reflective of the way the pressure changes over time, independent of the particular magnitude and duration of the profile. We look first to the claims. The claims themselves suggest that a profile’s shape is a separate characteristic that can be set independent of the profile’s magnitude and duration. Claims 22 and 44, which depend directly from claims 21 and 43, each recites a single additional limitation: “setting at least one of a magnitude and a duration of said pressure profile.” (emphases added). Because parent claims 21 and 43 recite that the profile’s “shape” is set independent of any monitored respiratory characteristics of a patient, the further setting of the profile’s “magnitude” and/or “duration” in claims 22 and 44 would be redundant if “shape” meant “magnitude and duration,” as construed by the district court. 2008-1164, -1193 10 Like the claims, the specification refers separately to each of these three characteristics: “[T]he defined pressure profile has a shape that generally corresponds to a patient’s normal flow,” ’575 patent col.20 ll.23-25 (emphasis added); “Multiple predefined pressure profiles, having different magnitudes, durations or both can be stored in a CPAP/PPAP device,” id. col.20, ll.53-55 (emphases added). A drawing best captures the point. The patent’s Figure 11B, reproduced below, shows three pressure profiles (P1, P2, P3) with different magnitudes (M1, M2, M3) and different durations (D1, D2, D3). But, despite having different magnitudes and durations, all three pressure profiles have the same general shape (a left-of-center “U”-shape), which “drops off quickly at the start of expiration then rises slowly.” Id. col.20 ll.63-64. The specification thus illustrates that a pressure profile is defined by its duration, magnitude, and shape. These three characteristics—duration, magnitude, and shape— are interrelated, but are different factors in the overall makeup of the pressure profile. The profile’s duration (e.g., D1, D2, D3 in Fig. 11B) is the time difference measured from the start to the end of the profile. The profile’s magnitude (e.g., M1, M2, M3 in Fig. 11B) is the pressure difference between the profile’s maximum and minimum pressures. But duration and magnitude alone do not define how quickly or slowly the profile drops off to 2008-1164, -1193 11 arrive at the minimum pressure, how long it might stay at any particular pressure, or how quickly or slowly the profile rises up to arrive back at the maximum pressure. These are considerations that relate to the “shape” of the profile. As shown in Figure 11B, the profile’s shape is the contour along which the pressure changes over time, independent of the particular magnitude and duration of the profile. The prosecution history does not contradict the claims or the specification. The disputed term was added to claims 21 and 43 in response to an anticipation rejection over U.S. Patent No. 5,598,838 (“Servidio”). Distinguishing Servidio, Respironics explained to the examiner that “the shape of [Servidio’s] expiratory model waveform is generated based on the inspiratory waveform, which is determined by monitoring the patient flow during inspiration. . . . Furthermore, it would not be obvious to modify the teachings of [Servidio] so that the shape of the expiratory waveform model is not based on the monitored respiratory characteristics of the patient.” J.A. 3719 (emphases added). This statement says nothing about the waveform’s magnitude or duration. It merely shows that Respironics understood that a “waveform” can have a “shape.” We conclude that a profile’s “shape” is not limited to its “magnitude and duration.” We therefore modify the construction of the word “shape” to mean “contour along which the pressure changes over time, describing the way in which the profile drops off to arrive at the minimum pressure and then rises up to arrive back at the maximum pressure, independent of the exact values of magnitude and duration.” d. Infringement of ’575 Patent Based on an incorrect construction of the word “shape,” the district court held on summary judgment that the Commercial Device did not infringe claims 21, 43, and 44 of 2008-1164, -1193 12 the ’575 patent. Because the Commercial Device supplies a pressure whose magnitude is based on the patient’s previous breath, the court determined that the pressure profile’s “shape” cannot be set independent of the patient’s respiratory characteristics. Respironics, 511 F. Supp. 2d. at 587. This would be true if “shape” were tied to “magnitude,” as it was under the district court’s construction. But, as previously explained, “shape” should not have been so limited. Moreover, Respironics points to record evidence that it believes shows that the Commercial Device utilizes a predetermined pressure profile having a so-called “bath-tub”-shape that is set independent of any monitored breathing characteristics. J.A. 1443 (Respironics’s claim chart accusing the Commercial Device of employing a “predetermined pressure profile ‘bath-tub’ shape”); id. 2334, 2420. Under our modified construction of “shape,” Respironics’s evidence may raise a genuine issue of material fact. We therefore vacate the grant of summary judgment with respect to noninfringement of the ’575 patent and remand the issue for consideration by the district court in the first instance under the modified construction. e. Disclaimer of CPAP and Bi-level Therapy On cross-appeal, Invacare challenges the district court’s claim construction of the ’802, ’193, and ’575 patents, which Invacare argues should be construed to expressly disclaim CPAP and Bi-level therapy from the scope of the claims. Because the district court found no infringement of these patents, Invacare’s cross-appeal admittedly seeks only “a second ground for non-infringement.” Cross-Appellant’s Br. at 1. This is an improper cross-appeal. See Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1252 (Fed. Cir. 2004) (“A cross-appeal is only proper if ‘a party seeks to enlarge its own rights 2008-1164, -1193 13 under the judgment or to lessen the rights of its adversary under the judgment.’”) (quoting Bailey v. Dart Container Corp. of Mich., 292 F.3d 1360, 1362 (Fed. Cir. 2002). We shall therefore treat Invacare’s claim construction argument as an alternative ground for affirming the judgment of noninfringement, and shall disregard Invacare’s noncompliant Reply Brief on this issue. See Chiron, 363 F.3d 1252 (“Although styled as a cross-appeal, this court treats this claim construction issue as an alternative ground for affirming the judgment.”). Moreover, because we have affirmed, supra, the judgment of noninfringement of the ’802 and ’193 patents, we shall limit our review to the ’575 patent. Having considered Invacare’s argument, we decline to read an express disclaimer into the claims, but nevertheless modify the construction of the term “predetermined pressure profile” in claims 21 and 43 of the ’575 patent to reflect the way this term was later used on summary judgment. Originally, Invacare had urged the district court to construe the term to require, among other things, that the pressure profile “is used to reduce the CPAP or bi-level pressure.” J.A. 1441 (chart of claim 21); id. 1465 (chart of claim 43). That construction was never expressly adopted in the Claim Construction Order. Id. at 25 (construing “predetermined pressure profile” only with regard to means-plus-function language). Later, on summary judgment, the district court apparently adopted Invacare’s earlier proposed construction, stating that “the predetermined pressure profile reduces the constant pressure of CPAP or the reduced EPAP pressure of bi-level therapy once the device detects the expiratory breathing phase.” Respironics, 511 F. Supp. 2d. at 603. On that basis alone, the district court held that claims 21 and 43 were not anticipated by two prior art patents. Id. 2008-1164, -1193 14 Respironics does not dispute the district court’s summary judgment interpretation, presumably because doing so would jeopardize the validity rulings. We agree with the district court’s summary judgment interpretation and find it to be entirely consistent with the way the term is used throughout the specification. E.g., ’575 patent col.20 ll.20-25 (distinguishing “predetermined pressure profile” from straight-line CPAP); id. col.21 ll.12-18 (distinguishing it from straight-line Bi-level EPAP). Thus, in order to maintain consistent claim constructions for both validity and infringement, we shall modify the construction of “predetermined pressure profile” to require, as the district court later did, that “the predetermined pressure profile reduces the constant pressure of CPAP or the reduced EPAP pressure of bi-level therapy once the device detects the expiratory breathing phase.” Respironics, 511 F. Supp. 2d. at 603. See Kim v. ConAgra Foods, Inc., 465 F.3d 1312, 1324 (Fed. Cir. 2006) (“The same claim construction governs for validity determinations as for infringement determinations.”). Despite the above modification, we nevertheless deny Invacare an alternative ground for affirming the grant of summary judgment of noninfringement of the ’575 patent. Invacare’s noninfringement argument is premised on the assertion that the Commercial Device is a standard CPAP device whose pressure remains constant. That fact, however, is in dispute. See J.A. 2975, Respironics’s Opp. Def.’s Mot. Partial Summ. J. 26 (“[H]owever, the accused device is not a standard CPAP device.”) (emphasis in original). Invacare’s own User Manual states that the Commercial Device “decreas[es] the pressure that the patient must exhale against” and contains “three (3) settings allow[ing] the user to adjust the extent of the pressure drops.” J.A. 5323. The User Manual goes on to explain that, in addition to the three adjustable settings, the 2008-1164, -1193 15 device “can be set for standard CPAP operation.” Id. The presence of the other three settings creates a genuine issue of material fact as to whether the Commercial Device can only operate as a standard CPAP device. We therefore conclude that Invacare’s CPAP argument does not provide an alternative basis to affirm the grant of summary judgment of noninfringement of the ’575 patent.