Abiomed, Inc. v. Maquet Cardiovascular LLC, Civil Action No. 16-10914-FDS

• Decision Date: 07 September 2018
• Docket Number: Civil Action No. 16-10914-FDS
• Parties: 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.
• Court: U.S. District Court — District of Massachusetts

329 F.Supp.3d 1

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.

Civil Action No. 16-10914-FDS

United States District Court, D. Massachusetts.

Signed September 7, 2018

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Cale V. Tolbert, White & Case LLP, Andrew T. Radsch, Pro Hac Vice, Ropes & Gray LLP, East Palo Alto, CA, Charles D. Larsen, Michael Kendall, Anne-Raphaelle Aubry, Yakov Malkiel, White & Case, LLP, Dalila A. Wendlandt, Ropes & Gray, Boston, MA, John Padro, Laura Rees Logsdon, Matthew Wisnieff, Robert E. Counihan, Scott T. Weingaertner, Stefan M. Mentzer, Silvia M. Medina, White & Case, LLP, New York, NY, Richard T. McCaulley, Pro Hac Vice, Ropes & Gray LLP, Chicago, IL, for Plaintiff/Counter-Defendant.

Andrew J. Ligotti, Christopher L. McArdle, Paul J. Tanck, Wade G. Perrin, Alston & Bird, LLP, New York, NY, Michael S. Connor, Travis J. Iams, Pro Hac Vice, Alston & Bird LLP, Charlotte, NC, Robert H. Stier, Jr., Margaret K. Minister, Pierce Atwood LLP, Portland, ME, Michael J. Derderian, Pierce Atwood LLP, Boston, MA, for Defendant/Third-Party Plaintiff/Counter-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.

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("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...8

A. Parties...8

B. The Underlying Technology...8

C. Patents at Issue...10

II. Standard of Review...11

A. The Words of the Claim...11

B. The Specification...12

C. The Prosecution History...13

D. Extrinsic Sources...13

III. Analysis...14

A. Intravascular Blood Pump...18

B. Guide Mechanism Terms...21

1. Lumens Generally...21

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

3. Elongate Lumen Associated with the Cannula...28

4. "Delimited by the Outer Cannula Surface"...30

C. Means-Plus-Function Terms...35

1. "Guide Mechanism"...36

2. "Blood Pressure Detection Mechanism" and "Pressure Sensing Element"...38

D. Rotor Terms...40

1. Rotor Blade Terms...40

2. Rotor Hub Term...43

E. Purge-Fluid Terms...44

1. "Passing Purge Fluid"...44

2. "First Conduit" and "Second Conduit"...47

F. Miscellaneous Terms...49

1. Perfusion...49

2. Measuring Pressure "Proximate" or "Adjacent" the Intravascular Blood Pump...50

3. "Distal Tip Member"...52

4. "Cannula Coupled to a Distal End of the Intravascular Blood Pump"...54

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

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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.

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( '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 there through 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...