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Abiomed, Inc. v. Maquet Cardiovascular, LLC

United States District Court, D. Massachusetts

September 7, 2018

ABIOMED, INC., Plaintiff/Counter-Defendant,
v.
MAQUET CARDIOVASCULAR LLC, Defendant/Third-Party Plaintiff/Counter-Defendant/ Counter-Claimant,
v.
ABIOMED EUROPE GMBH, Third-Party Defendant,
v.
ABIOMED R&D, INC., Third-Party Defendant/Counter-Claimant.

          MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION

          F. Dennis Saylor, IV United States District Judge.

         This is an action for patent infringement. Defendant Maquet Cardiovascular, LLC owns six patents directed to guidable intravascular blood pumps and related methods. Plaintiff Abiomed, Inc. (“Abiomed”) filed this action seeking declaratory judgment that it does not infringe those patents and that they are invalid.

         The parties have submitted proposed claim constructions of eighteen terms or groups of terms. The Court held a Markman hearing on April 24 and 25, 2018. The construction of the various terms in dispute is set forth below.

         Table of Contents

         I. Background ............................................................................................................................. 1

         A. Parties ............................................................................................................................... 1

         B. The Underlying Technology ............................................................................................ 1

         C. Patents at Issue ................................................................................................................. 2

         II. Standard of Review ................................................................................................................. 4

         A. The Words of the Claim ................................................................................................... 5

         B. The Specification .............................................................................................................. 6

         C. The Prosecution History ................................................................................................... 8

         D. Extrinsic Sources .............................................................................................................. 9

         III. Analysis ................................................................................................................................ 9

         A. Intravascular Blood Pump .............................................................................................. 14

         B. Guide Mechanism Terms ............................................................................................... 20

         1. Lumens Generally ....................................................................................................... 20

         2. Lumen Arranged Coaxially with the Cannula ............................................................ 25

         3. Elongate Lumen Associated with the Cannula ........................................................... 30

         4. “Delimited by the Outer Cannula Surface” ................................................................ 34

         C. Means-Plus-Function Terms .......................................................................................... 42

         1. “Guide Mechanism” ................................................................................................... 44

         2. “Blood Pressure Detection Mechanism” and “Pressure Sensing Element” ............... 48

         D. Rotor Terms .................................................................................................................... 51

         1. Rotor Blade Terms ...................................................................................................... 51

         2. Rotor Hub Term .......................................................................................................... 54

         E. Purge-Fluid Terms .......................................................................................................... 56

         1. “Passing Purge Fluid” ................................................................................................. 56

         2. “First Conduit” and “Second Conduit” ...................................................................... 59

         F. Miscellaneous Terms ......................................................................................................... 63

         1. Perfusion ..................................................................................................................... 63

         2. Measuring Pressure “Proximate” or “Adjacent” the Intravascular Blood Pump ....... 65

         3. “Distal Tip Member” .................................................................................................. 68

         4. “Cannula Coupled to a Distal End of the Intravascular Blood Pump” ....................... 70

         I. Background

         A. Parties

         Plaintiff Abiomed is a manufacturer of the “Impella” line of intravascular blood pumps, which it has been marketing since June 2008. (Am. Compl. ¶¶ 4, 8).

         Defendant Maquet Cardiovascular is the owner of several patents directed to intravascular blood pumps, including the six at issue in this case: U.S. Patent Nos. 7, 022, 100 (“the '100 patent”); 8, 888, 728 (“the '728 patent”); 9, 327, 068 (“the '068 patent”); 9, 545, 468 (“the '468 patent”); 9, 561, 314 (“the '314 patent); and 9, 597, 437 (“the '437 patent”).

         B. The Underlying Technology

         The patents at issue in this case involve guidance systems for intravascular blood pumps-essentially, miniature pumps that are inserted through a patient's vasculature into the heart for medical purposes. (See '100 patent, col. 1 ll. 48-51; id., col. 17 ll. 52-59). Intravascular blood pumps are used “(1) for acute support during cardio-pulmonary operations; (2) for short-term support while awaiting recovery of the heart from surgery; or (3) as a bridge to keep a patient alive while awaiting heart transplantation.” (Id., col. 1 ll. 22-27).

         Among the challenges in developing such pumps are miniaturization (that is, designing a pump that will work effectively but be small enough to be inserted); preventing the pump from damaging the heart or the blood (blood cells are delicate); and providing a method for guiding the device to the heart (such pumps are commonly inserted through the femoral artery in the thigh and guided through the body to the heart). (See id., col 1 l. 33-col. 2 l. 18). The patents at issue here principally address the third issue: safely and effectively guiding the pump into the heart.

         A subsidiary challenge is that of keeping blood out of the pump, where it may cause clotting or pump damage, and preventing frictional heating of the system. ('100 patent, col. 10 ll. 28-44). The patents at issue here also describe a “purge fluid delivery system” for addressing those problems.

         Generally, the blood pump systems discussed by the patents and the parties have the following basic structure: At the far end of the system is a cannula (designated 14 below), a small tube through which blood is drawn into the pump. Attached to the cannula is the blood pump itself (12), which includes a rotor, and is housed within a protective shroud. Extending from the back of the pump is a variable assembly (18), sometimes called a catheter, that can house the drive cable for the blood pump, purge fluid lines, and various guide mechanisms.

         (Image Omitted)

('100 patent, fig.1).

         C. Patents at Issue

         The amended pleadings include declaratory judgment claims for six patents: U.S. Patent Nos. 7, 022, 100 (“the '100 patent”); 8, 888, 728 (“the '728 patent”); 9, 327, 068 (“the '068 patent”); 9, 545, 468 (“the '468 patent”); 9, 561, 314 (“the '314 patent); and 9, 597, 437 (“the '437 patent”). These patents belong to the same “patent family, ” in that they all stem from provisional application No. 60/152, 249, filed September 3, 1999. Each subsequent application is either a continuation or division of the previous one; no new material was added to the disclosure. The specifications of the '100, '728, and '068 patents are identical, and the specifications of the '468, '314, and '437 patents are different only in that they explicitly incorporate as Appendices A and B certain material that was incorporated by reference in the other three patents-namely, two patent applications, also owned by Maquet, U.S. Patent App. Nos. 09/280, 988 and 09/280, 970.[1]

         Broadly speaking, the patents are directed to “[a]n improved intravascular blood pump system . . . and related methods involving the broad inventive concept of equipping the intravascular blood pump . . . with guiding features such that the intravascular blood pump can be selectively positioned at a predetermined location within the circulatory system of a patient.” (E.g., '100 patent, Abstract). The patents explain that a “significant drawback” of prior-art intravascular blood pumps is that they were “difficult to guide into the appropriate position within the circulatory system of a patient” because “the elongated catheter is incapable of providing the degree of control necessary to easily negotiate the pump through the tortuous pathways leading up to and into the heart.” (Id., col. 2 ll. 6-12). The supplemental guide mechanisms then available had the disadvantage of taking up valuable extra space in the blood vessel and requiring a larger access wound than would otherwise be necessary. (Id., col. 2 ll. 19-39). The patents purport to improve the prior art by equipping the pump with integrated guide mechanisms. (Id., col. 2 ll. 47-55).

         The patents describe three particular examples of such “integrated” guide mechanisms as “broad aspects of the present invention.” The first is an “‘over-the-wire' type guide mechanism, ” in which “a central lumen is formed through at least a portion of the intravascular blood pump system such that a guide element, such as a guide wire, may be progressed therethrough and advanced to the predetermined location in the circulatory system of the patient.” ('100 patent, col. 2 ll. 56-66). A “lumen, ” in this context, is the central cavity of a tubular structure. In the “over-the-wire” system, there is in effect a tube within a tube; the innermost tube contains a space (the lumen) through which the guide wire is inserted. The intravascular blood pump is then advanced along the guide element. (Id., col. 2 l. 66-col. 3 l. 2).

         The second broad aspect is a “‘side-rigger' or ‘rapid exchange' type guide mechanism, ” in which “a side lumen is formed along a length of at least one of the intravascular blood pump and the cannula” through which a “guide element, such as a guide wire, may be advanced to the predetermined location in the circulatory system of the patient.” (Id., col. 3 ll. 3-13). As with the “over-the-wire” design, the pump and cannula are then advanced along the guide element. (Id., col. 3 ll. 13-16).

         The third broad aspect of the invention is an “intravascular blood pump system” including a “conduit assembly” with a “guide catheter” and a “pump assembly, ” such that the conduit assembly is “precisely and efficiently guided into a desired position within the body through the use of conventional guiding techniques well known in interventional cardiology.” (Id., col. 3 ll. 17-36). “The pump assembly may thereafter be introduced into and guided within the conduit until the pump assembly is docked within the rotor shroud.” (Id., col. 3 ll. 36-39).

         II. Standard of Review

         The construction of claim terms is a question of law, which may in some cases rely on underlying factual determinations. Teva Pharm. USA, Inc. v. Sandoz, Inc.¸ 135 S.Ct. 831, 835, 837-38 (2015); see Markman v. Westview Instruments, 517 U.S. 370, 372 (1996) (“[T]he construction of a patent, including terms of art within its claim, is exclusively within the province of the court.”).

         In Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), the Federal Circuit clarified the proper approach to claim construction and set forth principles for determining the hierarchy and weight of the definitional sources that give a patent its meaning. The guiding principle of construction is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of . . . the effective filing date of the patent application.” Id. at 1313. Courts thus seek clarification of meaning in “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id. at 1314 (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)).

         A. The Words of the Claim

         The claim-construction analysis normally begins with the claims themselves.[2] The claims of a patent “define the invention to which the patentee is entitled the right to exclude.” Phillips, 415 F.3d at 1312 (citing Innova, 381 F.3d at 1115).

         A court may construe a claim term to have its plain meaning when such a construction resolves a dispute between the parties. See O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008); see also U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997) (“Claim construction is a matter of resolution of disputed meanings and technical scope, to clarify and when necessary to explain what the patentee covered by the claims, . . . [but] is not an obligatory exercise in redundancy.”).

         In some instances, the arrangement of the disputed term in the claims is dispositive. “This court's cases provide numerous . . . examples in which the use of a term within the claim provides a firm basis for construing the term.” Phillips, 415 F.3d at 1314. For example, because claim terms are normally used consistently throughout the patent, the meaning of a term in one claim is likely the meaning of that same term in another. Id. In addition, “the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.” Id. at 1315.

         B. The Specification

         “The claims, of course, do not stand alone.” Id. “Rather, they are part of a fully integrated written instrument, consisting principally of a specification that concludes with the claims.” Id. (citations and quotation marks omitted). For that reason, the specification must always be consulted to determine a claim's intended meaning. The specification “is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)).

         “In general, the scope and outer boundary of claims is set by the patentee's description of his invention.” On Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d 1331, 1338 (Fed. Cir. 2006); see also Phillips, 415 F.3d at 1315-17 (“[T]he interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelop with the claim.” (quoting Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998))). “[T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess.” Phillips, 415 F.3d at 1316. It may also reveal “an intentional disclaimer, or disavowal, of claim scope by the inventor.” Id. Therefore, the claims are to be construed in a way that makes them consistent with, and no broader than, the invention disclosed in the specification. On Demand, 442 F.3d at 1340 (“[C]laims cannot be of broader scope than the invention that is set forth in the specification.”); Phillips, 415 F.3d at 1316 (“[C]laims must be construed so as to be consistent with the specification, of which they are a part.” (quoting Merck & Co. v. Teva Pharm. USA, Inc., 347 F.3d 1367, 1371 (Fed. Cir. 2003))).

         Nevertheless, courts must be careful to “us[e] the specification [only] to interpret the meaning of a claim” and not to “import[] limitations from the specification into the claim.” Id. at 1323. A patent's “claims, not specification embodiments, define the scope of patent protection.” Kara Tech. Inc. v. Stamps.com Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009); see also Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1381 (Fed. Cir. 2009) (“[E]mbodiments appearing in the written description will not be used to limit claim language that has broader effect.”). “In particular, [the Federal Circuit] ha[s] expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.” Phillips, 415 F.3d at 1323. This is “because persons of ordinary skill in the art rarely would confine their definitions of terms to the exact representations depicted in the embodiments.” Id.

         Although this distinction “can be a difficult one to apply in practice[, ] . . . the line between construing terms and importing limitations can be discerned with reasonable certainty and predictability if the court's focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. “The construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction.” Id. at 1316 (quoting Renishaw, 158 F.3d at 1250).

         C. The Prosecution History

         After the specification and the claims themselves, the prosecution history is the next best indicator of term meaning. The prosecution history “consists of the complete record of the proceedings before the PTO and includes the prior art cited during the examination of the patent.” Id. at 1317. “Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent.” Id. “[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. The doctrine of prosecution disclaimer applies equally to statements made during inter partes review proceedings before the Patent Trial and Appeal Board, to “ensure that claims are not argued one way to maintain their patentability and in a different way against accused infringers.” Aylus Networks, Inc. v. Apple Inc., 856 F.3d 1353, 1360 (Fed. Cir. 2017).

         However, “because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes.” Phillips, 415 F.3d at 1316. As a result, courts generally require that “a patent applicant . . . clearly and unambiguously express surrender of subject matter” to disavow claim scope during prosecution. Voda v. Cordis Corp., 536 F.3d 1311, 1321 (Fed. Cir. 2008) (quoting Sorensen v. Int'l Trade Comm'n, 427 F.3d 1375, 1378-79 (Fed. Cir. 2005)); see Unwired Planet, LLC v. Apple Inc., 829 F.3d 1353, 1358 (Fed. Cir. 2016) (“[A] disclaimer or disavowel of claim scope must be clear and unmistakable, requiring words or expressions of manifest exclusion or restriction in the intrinsic record.”). Furthermore, “[p]rosecution history . . . cannot be used to limit the scope of a claim unless the applicant took a position before the PTO that would lead a competitor to believe that the applicant had disavowed coverage of the relevant subject matter.” Schwing GmbH v. Putzmeister Aktiengesellschaft, 305 F.3d 1318, 1324-25 (Fed. Cir. 2002).

         D. Extrinsic Sources

         Extrinsic evidence consists of “all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Phillips, 415 F.3d at 1317 (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995)). It “can help educate the court regarding the field of the invention and can help the court determine what a person of ordinary skill in the art would understand claim terms to mean.” Id. at 1319. However, extrinsic evidence suffers from a number of defects, including its independence from the patent, potential bias, and varying relevance. Id. at 1318-19. Such evidence is therefore “unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence, ” and courts may consider, or reject, such evidence at their discretion. Id. at 1319.

         III. Analysis

         There are 18 groups of terms at issue in the patents, which are summarized in the following chart.

Claim Term

Abiomed's Proposed Construction

Maquet's Proposed Construction

Patent: claim(s)

“intravascular blood pump”

“a drive cable-mounted rotor and rotor housing (i.e., body and shroud), which collectively are capable of insertion into a patient's circulatory system”

Ordinary meaning

'100: 16, 17 '728: 1, 6, 8, 10, 15 '068: 1, 10, 20 '468: 1, 22 '314: 1, 20, 27 '437: 1, 28

“guide mechanism” ('100: 16)

“elongate lumen sized to slideably receive a guide wire” ('468: 1, 22; '437: 1, 28; '314: 1, 20, 27)

“guide mechanism is configured as a second lumen . . . wherein the guide mechanism is configured to allow for a guide wire to slideably advance therealong” ('728: 1; '068: 1)

“a guide mechanism configured as an elongate lumen . . . a guide wire arranged to be advanced along the lumen” ('728: 10)

“guide mechanism configured as an elongate lumen and adapted to guide said intravascular blood pump . . . the method comprising: . . . advancing the blood pump system along the guide wire” ('068: 10)

“elongate lumen having a luminal interior . . . sufficiently large enough to accommodate the guide wire when the guide wire is advanced therealong . . . advancing the blood pump along the guide wire to the predetermined location” ('068: 20)

The terms to the left should be construed to have the same meaning: “lumen and guide wire not extending through the free space between the rotor blades”

Ordinary meaning

'100: 16 '728: 1, 10 '068: 1, 10, 20 '468: 1, 22 '314: 1, 20, 27 '437: 1, 28

“wherein the lumen is arranged coaxially with [at least one of a distal end or a proximal end] / [a portion of] the cannula”

“a guide lumen that passes coaxially through [at least one of a distal end or a proximal end] / [a portion of] the cannula and extends through the catheter”

Ordinary meaning

'728: 10 '068: 10, 20 '314: 1, 20

“an elongate lumen associated with the cannula”

“a permanent lumen formed along the side of the cannula”

Ordinary meaning

'468: 1, 22 '314: 27 '437: 1, 28

“wherein an axis coaxial with and extending through a portion of said guide mechanism extends through a region delimited by the outer cannula surface”

“guide lumen integrally formed within the surface of the cannula”

Ordinary meaning

'728: 1 '068: 1

“a guide mechanism adapted to guide said intravascular blood pump and cannula to a predetermined location within the circulatory system of a patient”

Means plus function: Claimed function-“guiding said intravascular blood pump and cannula to a predetermined location within the circulatory system of the patient” Claimed structures-“(a) a guide wire passing slideably through a central lumen extending through a drive cable assembly, blood pump, and cannula; (b) a guide wire passing slideably through a lumen extending through a guide carriage integrally formed along at least a portion of the cannula sidewall; or (c) a conduit assembly, including guide catheter, a rotor shroud, and a cannula, which is capable of docking to a separate pump assembly”

Ordinary meaning

'100: 16

“blood pressure detection mechanism to detect the pressure of the blood proximate at least one of the intravascular blood pump and cannula”

Means plus function: Claimed function-“to detect the pressure of the blood proximate at least one of the intravascular blood pump and cannula” Claimed structures-“(a) a fluid filled column disposed within at least a portion of the cannula, (b) a piezoelectric element coupled to at least one of the intravascular blood pump and cannula, (c) a strain gauge coupled to at least one of the intravascular blood pump and cannula, and (d) calculating blood pressure based on the relationship between the torque and motor current of a motor used to drive the rotor”

Ordinary meaning

'100: 16

'468: 1 '314: 1

“pressure sensing element configured to sense pressure proximate the intravascular blood pump”

“blade extending radially outward from the rotor hub”

“blade[s] extending radially from the rotor hub”

“blade[s] shaped as an extension of a radius of the rotor hub, not including helical, corkscrew or screw-shaped”

Ordinary meaning

'728: 1, 10 '068: 1, 10, 20 '468: 1, 2, 22 '314: 1, 2, 20,

27 '437: 1, 28

“a rotor having a rotor hub tapering in the distal direction”

Plain meaning, where patentee disclaimed a hub where any portion tapers in the proximal direction

Ordinary meaning

'728: 1, 10 '068: 1, 10, 20 '468: 1, 2, 22 '314: 1, 2, 20,

27 '437: 1, 28

“[first lumen / purge lumen] . . . operatively arranged to deliver purge fluid [to / towards] the intravascular blood pump”

“arranged to operate such that purge fluid is delivered to the blood pump where the purge fluid does not go through the rotor bearings and into the bloodstream”

Ordinary meaning

'728: 1 '068: 1 '468: 1, 22 '314: 1, 20, 27

“passing purge fluid through the purge lumen to the intravascular blood pump”

“passing purge fluid through one of the first and second conduits, through the housing and purge lumen to the intravascular blood pump”

“passing purge fluid to the blood pump where the purge fluid does not go through the rotor bearings and into the bloodstream”

Ordinary meaning

'437: 1 '437: 28

“first conduit . . . second conduit”

“a pair of conduits for introducing and returning purge fluid”

Ordinary meaning

'728: 8 '068: 9 '468: 1, 22 '314: 1, 20, 27 '437: 10, 29

“perfusing / perfusion [of a patient]”

“rerouting blood to a point downstream from the introduction site of the intravascular blood pump into the vasculature of the patient”

Ordinary meaning

'068: 1, 10, 20

“[detect the pressure of the blood] proximate at least one of the intravascular blood pump and cannula”

“at the opening of the blood pump or the cannula

Ordinary meaning

'100: 16

“[detect the pressure of the blood / sense pressure] proximate the intravascular blood pump”

“[measuring pressure / calculating blood pressure] adjacent the intravascular blood pump”

“at the opening of the blood pump”

Ordinary meaning

'728: 6, 10 '068: 7, 10 '468: 1, 22 '314: 1, 20, 27 '437: 1, 8, 12

“distal tip member”

“rod bonded to the end of the cannula”

Ordinary meaning where the “distal tip member” is not a guidewire

'314: 21 '437: 22

“cannula coupled to a distal end of the intravascular blood pump”

Maquet disclaimed a cannula with a “pigtail, J-shaped, helical, or helix shape, or stem/tail on the distal end of the cannula”

Ordinary meaning

'468: 1, 22

         The Court will address each term in turn.

         A. Intravascular Blood Pump

Claim Term

Abiomed's Proposed Construction

Maquet's Proposed Construction

Patent: claim(s)

“intravascular blood pump”

“a drive cable-mounted rotor and rotor housing (i.e., body and shroud), which collectively are capable of insertion into a patient's circulatory system”

Ordinary meaning

'100: 16, 17 '728: 1, 6, 8, 10, 15 '068: 1, 10, 20 '468: 1, 22 '314: 1, 20, 27 '437: 1, 28

         Abiomed argues that the term “intravascular blood pump” should be construed to be limited to “a drive cable-mounted rotor and rotor housing”-in other words, describing a device in which the motor is outside the human body and driven by a cable.[3] In support of that interpretation, Abiomed contends that (1) all the embodiments described in the patent include a cable-mounted rotor coupled to a motor external to the patient's body; (2) the guide mechanisms described in the specifications indicate that they are specifically designed for pumps that use a rotating drive cable; (3) the patent does not meet the written-description requirement or enable one of skill in the art to make and use a blood pump without a rotating drive cable; and (4) Maquet has given up a broader scope by way of statements made before the PTO. (Abiomed Opening Br. at 31). Maquet acknowledges that the only commercial intravascular blood pump available at the time of the invention was the Hemopump, which was a cable-driven rotor pump. (Maquet Opening Br. at 7). And it does not attempt to argue that its patents teach a person of ordinary skill in the art to make and use a blood pump that is not cable-driven. Nevertheless, it contends that the description of a cable-driven pump in the specification is merely a preferred embodiment.

         Claim terms are to be given their “ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification.” Thorner v. Sony Comput. Entm't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012). While a patentee may use the specification to redefine a term, “[i]t is not enough for a patentee to simply disclose a single embodiment or use a work in the same manner in all embodiments, the patentee must ‘clearly express an intent' to redefine the term.'” Id. (quoting Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008)). Here, to limit the term “intravascular blood pump”-which, on its own, makes no reference to how the pump is driven-to cable-driven pumps, simply because the only examples in the specification are cable-driven pumps, would be inappropriate. The specification explicitly recognizes that cable-driven pumps are just an example: “Intravascular blood pumps comprise miniaturized blood pumps capable of being percutaneously or surgically introduced into the vascular system of a patient, typically to provide left and/or right heart support. One type of intravascular pump is an axial flow blood pump comprising a cable-mounted rotor surrounded by a protective shroud.” ('437 patent col. 1 l. 65-col. 2 l. 3 (emphasis added)).

         Abiomed argues that the claims should be limited to cable-driven pumps because the particular guide mechanisms disclosed are specifically designed for cable-driven pumps. But although the specification repeatedly describes the guide mechanisms in terms of a cable-driven pump and explains how they could be integrated with such a pump, Abiomed has not shown that the guide mechanisms of the invention actually require a cable-driven pump or even that they contain features that would be useless without such a pump.

         Abiomed also contends that the specification repeatedly characterizes the “present invention” as a cable-driven pump, and that such a characterization should be limiting. See Trading Techs. Int'l, Inc. v. eSpeed, Inc., 595 F.3d 1340, 1353-54 (Fed. Cir. 2010); Netcraft Corp. v. eBay, Inc., 549 F.3d 1394, 1398-400 (Fed. Cir. 2008). But the strongest statements in the specifications describing “the present invention” do not make any specific mention of cable-driven pumps. The patents state: “The present invention is directed at eliminating and/or reducing the effects of the foregoing drawbacks of prior art intravascular blood pumps” and “[t]he present invention overcomes the drawbacks of the prior art by providing an improved intravascular blood pump equipped with integrated features for selectively guiding the intravascular blood pump to a predetermined location in the patient's circulatory system.” ('437 patent, col. 2 ll. 57-67; see also id., col. 8 ll. 50-64). But the “drawbacks” discussed have to do with difficulty guiding the catheter, not any particular difficulty with the drive cable. And the other statements to which Abiomed points are explicitly termed as “broad aspects” of the present invention, or manifestations or embodiments of those broad aspects. (See id., col. 9 ll. 13-31; id., col. 13 l. 63-col. 14 l. 14; id., col. 15 ll. 5-21; see generally id., col. 3 l. 5-col. 4 l. 4).

         Abiomed also points to two parts of the prosecution history. In the notice of allowance for the '068 patent, the examiner stated: “Sammler lacks several critical feature [sic] of the invention. Sammler lacks both a first lumen arranged to deliver purge fluid, and a guide mechanism configured as an elongate lumen. Significantly, Sammler relies on the motor-driven pump of Siess to move blood through vessels (Siess, Figs. 2, 3). Since the motor of Siess occupies the entire cross-section of the lumen, no space remains for a lumen to pass a guide wire or purge fluid.” (Abiomed Opening Markman Br. Ex. 8-B at MAQ00005189).

         That history is likewise not dispositive. First, the statement of an examiner in the notice of reasons for allowance does not normally constitute clear and unmistakable disclaimer of scope by the patentee, unless it illuminates the meaning a person of ordinary skill in the art would ascribe to an argument made by the patentee. Salazar v. Procter & Gamble Co., 414 F.3d 1342, 1347 (Fed. Cir. 2005); ACCO Brands, Inc. v. Micro Sec. Devices, Inc., 346 F.3d 1075, 1079 (Fed. Cir. 2003) (“[T]here is no obligation to respond to an examiner's statement of Reasons for Allowance, and the statement of an examiner will not necessarily limit a claim . . . .”). Second, the fact that the motor-driven pump of Siess specifically is incompatible with a lumen that would permit the passage of a guide wire or purge fluid does not mean that every motor-driven pump is so incompatible.

         During the IPR proceedings for the '468, '314, and '437 patents, Maquet included an annotated version of Figure 1 of the patents and described it as follows:

Figure 1 illustrates an exemplary embodiment of the present invention, with guide wire (22) extending out the distal end of the cannula, along with various other features associated with this invention. The above shows the intravascular blood pump, catheter, cannula, and guide mechanism located within the circulatory system. This embodiment is designed to support the function of the left ventricle circulating blood. Once inserted, intravascular pump (12) is located within the aorta (Ex. 1001, 9:13-16, Fig. 1). Cannula (14) traverses the aortic valve, allowing blood to flow from the left ventricle to the pump and then into the aorta (id., 9:28-32, Fig. 1). Also, the above figure shows catheter (18), which moves the intravascular pump through the circulatory system, maintains the pump and cannula in the proper location, and allows for communication between pump features and devices located outside the body (id., 9:58-10:17).

(Abiomed Opening Markman Br. Ex. 16 at 12-13; see also Id. Ex. 18 at 11-12; id. Ex. 21 at 11-12; id. Ex. 22 at 11-12). Abiomed contends that the statement that there are “pump features and devices located outside the body” means that Maquet “emphasized that the drive cable is an essential aspect of its claimed invention.” (Abiomed Opening Markman Br. at 36). But Maquet was merely describing Figure 1, which is only an embodiment of the invention, for the purposes of introducing the invention to the PTAB. It did not distinguish any prior art on the basis of the motor being located outside the body, and did not purport to define the claimed invention. It is no more limiting or a disclaimer than the appearance of figure 1 in the patents themselves.

         Whether the claims are enabled or supported by adequate written description are not issues before the Court at this time. Nonetheless, the question is worth addressing, because the treatment of this concept is not intuitive.

         As to enablement, Abiomed argues that the claims must be limited to cable-driven pumps because the specification does not enable or describe other types of pumps. But that is not strictly correct. “Whether claims are sufficiently enabled by a disclosure in a specification is determined as of the date that the patent application was first filed . . . .” Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999); In re '318 Patent Infringement Litig., 583 F.3d 1317, 1323 (Fed. Cir. 2009). “If the original inventor has at that time enabled the use of an entire class of products, a claim covering that entire class is warranted. But if the class subsequently expands to include other species not conceived at the time of the first patent, the generic claim language will allow the first inventor to capture those new species within the scope of his claim.” Mark A. Lemley, The Economics of Improvement in Intellectual Property Law, 75 Tex. L. Rev. 989, 1009 (1997); see CFMT, Inc. v. Yieldup Int'l Corp., 349 F.3d 1333, 1340 (Fed. Cir. 2003) (“Improvement and selection inventions are ubiquitous in patent law; such developments do not cast doubt on enablement of the original invention.”). Thus, for example, an inventor of an improved windshield wiper may claim a car equipped with those improved wipers even if cars are already in the prior art, and that claim may cover a car with an improved engine that did not exist at the time of patenting as long as the car also includes the wipers of the patented invention. See Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339-41 (Fed. Cir. 2003) (discussing In re Hogan¸ 559 F.2d 595 (C.C.P.A. 1977), in depth).

         Thus, Maquet may well have a valid patent on guide mechanisms attached broadly to all “intravascular blood pumps” that was fully enabled at the time of patenting. Abiomed may well have significantly improved intravascular blood pumps, but Maquet would not be required to have enabled blood pumps not existing at the time of its application.

         The written-description requirement is a separate issue. In Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), the Federal Circuit expressly held that the written-description requirement is separate from the enablement requirement, and that a patentee may enable his invention while simultaneously failing to describe it. Id. at 1344-45. It is not clear how that doctrine interacts with the newly-discovered-species doctrine of In re Hogan. See Abbvie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir. 2014) (explaining genus-species written description); Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed. Cir. 2004) (discussing enablement, written description, and new matter in the context of priority to earlier applications); see also Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1365-66 (Fed. Cir. 2010) (en banc) (Rader, J., dissenting in part and concurring in part) (explaining the effect of having a written-description requirement separate from enablement on genus-species improvement patents).

         The Court need not resolve the issue at this stage. For now, it is sufficient to note that Maquet has taken the position that its claim is broad enough to encompass intravascular blood pumps that include cable-driven blood pumps and other types of pumps. It may later have to defend that scope against a challenge under § 112. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1381 (Fed. Cir. 2012) (“[A] patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage.”). But that issue will be resolved when and if it is raised.

         Accordingly, the term “intravascular blood pump” will be given its ordinary meaning.

         B. Guide Mechanism Terms

         1. Lumens Generally

Claim Term

Abiomed's Proposed Construction

Maquet's Proposed Construction

Patent: claim(s)

“guide mechanism” ('100: 16)

“elongate lumen sized to slideably receive a guide wire” ('468: 1, 22; '437: 1, 28; '314: 1, 20, 27)

“guide mechanism is configured as a second lumen . . . wherein the guide mechanism is configured to allow for a guide wire to slideably advance therealong” ('728: 1; '068: 1)

“a guide mechanism configured as an elongate lumen . . . a guide wire arranged to be advanced along the lumen” ('728: 10)

“guide mechanism configured as an elongate lumen and adapted to guide said intravascular blood pump . . . the method comprising: . . . advancing the blood pump system along the guide wire” ('068: 10)

“elongate lumen having a luminal interior . . . sufficiently large enough to accommodate the guide wire when the guide wire is advanced therealong . . . advancing the blood pump along the guide wire to the predetermined location” ('068: 20)

The terms to the left should be construed to have the same meaning: “lumen and guide wire not extending through the free space between the rotor blades”

Ordinary meaning

'100: 16 '728: 1, 10 '068: 1, 10, 20 '468: 1, 22 '314: 1, 20, 27 '437: 1, 28 ...


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