Maquet Cardiovascular LLC v. Abiomed Inc.

• Decision Date: 12 September 2022
• Docket Number: Civil Action 17-12311-FDS
• Parties: MAQUET CARDIOVASCULAR LLC, Plaintiff/Counterdefendant, v. ABIOMED, INC., ABIOMED R&D, INC., and ABIOMED EUROPE GMBH, Defendants/Counterclaimants,
• Court: U.S. District Court — District of Massachusetts

MAQUET CARDIOVASCULAR LLC, Plaintiff/Counterdefendant, v. ABIOMED, INC., ABIOMED R&D, INC., and ABIOMED EUROPE GMBH, Defendants/Counterclaimants,

Civil Action No. 17-12311-FDS

United States District Court, D. Massachusetts

September 12, 2022

MEMORANDUM AND ORDER ON DEFENDANTS' MOTION FOR JUDGMENT ON THE PLEADINGS

SAYLOR, C.J.

This is a case for patent infringement derived from related litigation between the parties in Abiomed, Inc. v. Maquet Cardiovascular LLC, No. 16-cv-10914-FDS (D. Mass.) (“Abiomed I”).

Here plaintiff Maquet Cardiovascular LLC has sued defendants Abiomed, Inc., Abiomed R&D, Inc., and Abiomed Europe GmbH for infringing U.S. Patent No. 10,238,783 (“the '783 patent”).^[1] Defendants (collectively “Abiomed”) have counterclaimed for declaratory judgment of noninfringement.

This case, like Abiomed I, concerns patents owned by Maquet directed to guidable intravascular blood pumps and methods related to their use. Abiomed manufactures the “Impella” line of intravascular blood pumps which Maquet alleges infringes its related patents.

Abiomed has filed a motion for a partial judgment on the pleadings pursuant to Fed.R.Civ.P. 12(c). It contends that Claim 24 of the '783 patent is invalid due to the on-sale bar of 35 U.S.C. § 102.

For the following reasons, the motion for partial judgment on the pleadings will be denied.

I. Background

A. Factual Background

1. Pigtail-Shaped Distal Tip

Claim 24 of the '783 patent describes

[a]n intravascular blood pump system comprising . . . a pigtail shaped distal tip or a J-shaped distal tip, wherein when the intravascular blood pump is positioned in the patient to provide left-heart support the pigtail shaped distal tip or the J-shaped distal tip are wholly within a left ventricle of the patient.

('783 patent, col. 37 ll. 32-33, col. 38 ll. 10-14). According to the parties, that claim finds support in the specification through the incorporation of U.S. Patent Application No. 09/280,988 (“the '988 application”), entitled “Steerable Cannula.” (Id., col. 20 ll. 24-44; id., col. 21 l. 24-col. 27 l. 11). That application, as set forth in the '783 patent, explains that

[v]arious distal tip configurations can be selected for cannula 1120, depending on the particular application as appreciated by those of ordinary skill in the art. For example, a pigtail shape can be used for crossing the aortic valve retrograde. The pigtail shape, illustrated in FIG. 30, can be formed by bonding or thermal welding or otherwise attaching a thermoplastic rod 1174 formed into a loop at the distal end of cannula 1120.

(Id., col. 26 ll. 37-44). The parties do not contest, and the Court has previously noted, that the '988 application was abandoned and never published, except to the extent that it may have been incorporated into later patents. (See Abiomed I, Docket No. 241 (“Abiomed I Mem. & Order on Claim Constr.”) at 3 n.1).

2. Patent and Claim Priority

The application for the '783 patent was filed on September 21, 2018, although the patent claims priority through a lineage of applications dating back to September 3, 1999. The priority claim of the '783 patent provides:

This application is a divisional of co-pending U.S. patent application Ser. No. 15/675,310, filed Aug. 11, 2017, which is a divisional of U.S. patent application Ser. No. 14/966,669, filed Dec. 11, 2015 (now U.S. Pat. No. 9,789,238), which is a divisional of U.S. patent application Ser. No. 14/543,815, filed Nov. 17, 2014 (now U.S. Pat. 9,327,068, issued May 3, 2016), which is a continuation of U.S. patent application Ser. No. 12/772,810, filed May 3, 2010 (now U.S. Pat. No. 8,888,728, issued Nov. 18, 2014), which is a continuation of U.S. patent application Ser. No. 11/375,926, filed Mar. 15, 2006 (now U.S. Pat. No. 7,731, 675, issued Jun. 8, 2010), which is a divisional of U.S. patent application Ser. No. 10/070,178, filed Jul. 19, 2002, (now U.S. Pat. No. 7,022,100, issued Apr. 4, 2006), which claims the benefit of PCT/US00/24515, filed Sep. 1, 2000, which claims the benefit of provisional U.S. patent application Ser. No. 60/152,249 filed Sep. 3, 1999. We hereby claim priority to the aforementioned application(s) and also incorporate herein by reference each of the afore-listed patents and application in their entirety.

('783 patent, col. 1 ll. 6-25).

However, the description of a pigtail-shaped distal tip present in the '783 patent is absent from the earliest patent in the priority chain, U.S. Patent No. 7,022,100 (“the '100 patent”). The '100 patent does not have a claim analogous to Claim 24, nor does it reproduce the '988 application within the specification. Instead, the '100 patent incorporates the '988 application (as well as another related application) by reference:

It is also contemplated to incorporate various pressure sensing and/or guidability features into at least one of the cannula 14 and pump 12. Such features may include, but are not necessarily limited to, those shown and described in commonly-owned and co-pending U.S. patent application Ser. No. 09/280,988 (filed March 30, 1999) entitled “Steerable Cannula,” and U.S. patent application Ser. No. 09/280,970 (filed March 30, 1999) entitled “Pressure Sensing Cannula,” the disclosures of which are hereby expressly incorporated by reference as if set forth herein in their entirety.

('100 patent, col. 18 ll. 21-30).

3. 37 C.F.R. § 1.57

In 2004, the United States Patent and Trademark Office (“PTO”) issued 37 C.F.R. § 1.57 to codify standards concerning the incorporation by reference of materials into a patent's specification. See Changes to Support Implementation of the United States Patent and Trademark Office 21st Century Strategic Plan, 69 Fed.Reg. 56,482-01, 2004 WL 2092623, (Sept. 21, 2004). That regulation sets forth restrictions on the kind of material that may be incorporated by reference to support an application.

As relevant here, the regulation mandates that “‘[e]ssential material' may be incorporated [in a specification] by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication,” as long as the referenced patent or application “[did] not itself incorporate such essential material by reference.” 37 C.F.R. § 1.57(d).^[2] As a result, “essential material” may no longer be conveyed in a specification by incorporating by reference an unpublished or abandoned patent application.

The regulation defines “essential material” in relevant part as follows:

“Essential material” is material that is necessary to

1. Provide a written description of the claimed invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and set forth the best mode contemplated by the inventor of carrying out the invention as required by [35 U.S.C. § 112(a); or]

2. Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by [35 U.S.C. § 112(b).]

Id. § 1.57(d).

4. Amendments to Priority Chain Applications

After the promulgation of 37 C.F.R. § 1.57 in 2004, Maquet prosecuted three patents that claimed priority to the '100 patent: U.S. Patent Nos. 7,731,675 (“the '675 patent”); 8,888,728 (“the '728 patent”), and 9,327,068 (“the '068 patent”). The specifications for each incorporated by reference (using language identical to that in the '100 patent) the description of a pigtailshaped distal tip in the abandoned '988 application.

In November 2016, Maquet sought to amend the specification of a pending patent application, which claimed priority to the '100 patent, that would eventually issue as the '238 patent. (Docket No. 236, Ex. 9). Specifically, Maquet amended the specification by physically incorporating the '988 application into the specification rather than incorporating it by reference, thereby reproducing the '988 application's description of the pigtail-shaped distal tip within the specification itself. ('238 patent, col. 26 ll. 23-30). On June 21, 2017, the PTO permitted the amendment, stating that “no new matter ha[d] been added.” (Docket No. 236, Ex. 10 at 2).

In September 2018, Maquet applied for what became the '783 patent. That application physically incorporated the '988 application in the same manner as the '238 patent. Thus, the '238 and '783 patents both contain the written description of a pigtail-shaped distal tip that had been incorporated by reference in previous patents in the priority chain. The '675, '728, and '068 patents, however, do not.

B. Procedural Posture

The '238 patent was issued on October 17, 2017, during the pendency of Abiomed I. Maquet sought to add allegations of infringement of the '238 patent in Abiomed I, but when Abiomed objected, it agreed to assert those claims in a separate lawsuit. Maquet accordingly filed this action on November 22, 2017.

On March 26, 2019, the PTO issued the '783 patent, and Maquet thereafter amended the complaint to add allegations of infringement of the '783 patent.

Abiomed has moved for partial judgment on the pleadings on the ground that claim 24 of the '783 patent is invalid. Specifically, it contends that the '783 patent cannot claim priority to the '988 application, and therefore it is invalid due to the on-sale bar of 35 U.S.C. § 102. II. Standard of Review

A Rule 12(c) motion for judgment on the pleadings “is treated much like a Rule 12(b)(6) motion to dismiss.” Perez-Acevedo v. Rivero-Cubano, 520 F.3d 26, 29 (1st Cir. 2008). It differs from a Rule 12(b)(6) motion primarily because it is filed after the close of pleadings and “implicates the pleadings as a whole.”...