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Abbott Cardiovascular Systems, Inc. v. Edwards Lifesciences Corp.

United States District Court, D. Delaware

October 22, 2019

ABBOTT CARDIOVASCULAR SYSTEMS, INC. and EVALVE, INC., Plaintiffs,
v.
EDWARDS LIFESCIENCES CORP. and EDWARDS LIFESCIENCES, LLC, Defendants.

          MEMORANDUM ORDER

          Honorable Maryellen Noreika United States District Judge.

         At Wilmington this 22nd day of October 2019:

         IT IS HEREBY ORDERED that the claim terms of U.S. Patent Nos. 7, 288, 097 (“the '097 patent”), 6, 752, 813 (“the '813 patent”), 7, 563, 267 (“the '267 patent”), 7, 736, 388 (“the '388 patent”) and 8, 057, 493 (“the '493 patent”) with agreed-upon constructions are construed as follows (see D.I. 293 at 1-2):

1. “proximal” means “the direction toward the end of the device to be manipulated by the user outside the patient's body” ('813 and '388 Patents)
2. “distal” means “the direction toward the working end of the device that is positioned at the treatment site and away from the user” ('813 Patent)
3. “downstream surface of at least one leaflet” means “a surface of the heart valve leaflet facing downstream in relation to the flow of blood, e.g., the ventricular surface of a mitral valve leaflet” ('813 Patent)
4. “atraumatically” means “without causing any significant clinical impairment of the tissue; minor penetration or denting permitted” ('388 Patent)
5. “may be left to attach the free edges of the leaflets together” shall be given its plain and ordinary meaning, which does not require direct contact between the leaflet free edges ('097 Patent)[1]
6. “wherein the distal element is protrudable radially outward” means “wherein the distal element is capable of being protruded radially outward from the longitudinal axis of the interventional catheter, which axis may extend below the catheter” ('813 and '388 Patents)[2]

         Further, as announced at the hearing on October 17, 2019, IT IS HEREBY ORDERED that the disputed claim terms of the '097, '813, '267, '388 and '493 Patents are construed as follows:

1. “a first pair of elements adapted to be brought up beneath a pair of valve leaflets from the ventricular side and a second pair of elements adapted to be brought down over the pair of valve leaflets from the atrial side, wherein the first pair of elements engages the ventricular side of both leaflets and the second pair of element engages the atrial side of both the leaflets to capture both leaflets” is not a means-plus-function limitation subject to 35 U.S.C. § 112(6) and the term shall be given its plain and ordinary meaning ('097 Patent, claim 1)
2. “free end” means “an end not attached to the other free end or the coupling member” ('267 Patent, claims 2, 5, 7 & 12; '388 Patent, claims 6, 11, 14, 16, 17, 22, 28, 31, 33 & 34; '493 Patent, claims 2, 5, 7, 15, 21, 24, 26 & 34)
3. “coupled to” shall be given its plain and ordinary meaning, which permits indirect coupling[3]
4. “pivotably coupled” means “coupled so as to rotate around a fixed point” ('388 Patent, claims 6, 11, 14, 16, 17, 22, 28, 31, 33 & 34)
5. “an inverted position wherein the engagement surfaces face away from each other” means “a position where the free ends of the fixation elements point in a distal direction and where the engagement surfaces face away from each other” ('267 Patent, claims 2, 5, 7 & 12; '493 Patent, claims 21, 24, 26 & 34)
6. “adapted to move the fixation elements between the closed position and the first open position” means “adapted to move the fixation elements from a closed position to a first open position and also from a first open position to a closed position, i.e., it allows a back-and-forth movement” ('388 Patent, claim 11; '493 Patent, claims 2, 5, 7 & 15)
7. “the fixation elements are moveable between a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other” means “the fixation elements are moveable from a closed position wherein the engagement surfaces face each other to a first open position wherein the engagement surfaces are positioned away from each other” ('493 Patent, claims 2, 5, 7 & 12)
8. “guide conduit” shall be given its plain and ordinary meaning, which is “a channel that you can bring things towards and away from a location” ('813 Patent, claims 119 & 123)
9. “interventional tool” means “interventional catheter” ('813 Patent, claim 123)

         The parties briefed the issues (see D.I. 215) and submitted an appendix containing both intrinsic and extrinsic evidence (see D.I. 216, 242 & 243; see also D.I. 185 & 186). Neither side provided a tutorial describing the relevant technology. The Court carefully reviewed all submissions in connection with the parties' contentions regarding the disputed claim terms, heard oral argument (see D.I. 296) and applied the following legal standards in reaching its decision:

         I.LEGAL STANDARD

         A. Claim Construction

         “[T]he ultimate question of the proper construction of the patent [is] a question of law, ” although subsidiary fact-finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015). “[T]he words of a claim are generally given their ordinary and customary meaning [which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en banc) (internal citations and quotation marks omitted). Although “the claims themselves provide substantial guidance as to the meaning of particular claim terms, ” the context of the surrounding words of the claim also must be considered. Id. at 1314. “[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent.” Id. at 1321 (internal quotation marks omitted).

         The patent specification “is always highly relevant to the claim construction analysis . . . [as] it is the single best guide to the meaning of a disputed term.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). It is also possible that “the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs.” Phillips, 415 F.3d at 1316. “Even when the specification describes only a single embodiment, [however, ] the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction.” Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (internal quotation marks omitted) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)).

         In addition to the specification, a court “should also consider the patent's prosecution history, if it is in evidence.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). The prosecution history, which is “intrinsic evidence, . . . consists of the complete record of the proceedings before the PTO [Patent and Trademark Office] and includes the prior art cited during the examination of the patent.” Phillips, 415 F.3d at 1317. “[T]he prosecution history can often inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Id.

         In some cases, courts “will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period.” Teva, 135 S.Ct. at 841. Extrinsic evidence “consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d at 980. Expert testimony can be useful “to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field.” Phillips, 415 F.3d at 1318. Nonetheless, courts must not lose sight of the fact that “expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence.” Id. Overall, although extrinsic evidence “may be useful to the court, ” it is “less reliable” than intrinsic evidence, and its consideration “is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence.” Id. at 1318-19. Where the intrinsic record unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics, 90 F.3d at 1583).

         B. Indefiniteness

         “The primary purpose of the definiteness requirement is to ensure that the claims are written in such a way that they give notice to the public of the extent of the legal protection afforded by the patent, so that interested members of the public, e.g. competitors of the patent owner, can determine whether or not they infringe.” All Dental Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d 774, 779-80 (Fed. Cir. 2002) (citing Warner-Jenkinson Co. v. Hilton-Davis Chem. Co., 520 U.S. 17, 28-29 (1997)). Put another way, “[a] patent holder should know what he owns, and the public should know what he does not.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 731 (2002).

         A patent claim is indefinite if, “viewed in light of the specification and prosecution history, [it fails to] inform those skilled in the art about the scope of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2129 (2014). A claim may be indefinite if the patent does not convey with reasonable certainty how to measure a claimed feature. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1341 (Fed. Cir. 2015). But “[i]f such an understanding of how to measure the claimed [feature] was within the scope of knowledge possessed by one of ordinary skill in the art, there is no requirement for the specification to identify a particular measurement technique.” Ethicon Endo-Surgery, Inc. v. Covidien, Inc., 796 F.3d 1312, 1319 (Fed. Cir. 2015).

         Like claim construction, definiteness is a question of law, but the Court must sometimes render factual findings based on extrinsic evidence to resolve the ultimate issue of definiteness. See, e.g., Sonix Tech. Co. v. Publications Int'l, Ltd., 844 F.3d 1370, 1376 (Fed. Cir. 2017); see also Teva, 135 S.Ct. at 842-43. “Any fact critical to a holding on indefiniteness . . . must be proven by the challenger by clear and convincing evidence.” Intel Corp. v. VIA Techs., ...


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