DR Andrew Kerr v. Endologix Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Dr. Andrew Kerr (New York)
  • Defendant: Endologix, Inc. (Delaware), TriVascular Technologies, Inc. (Delaware), and TriVascular, Inc. (California)
  • Plaintiff’s Counsel: Blank Rome LLP
• Case Identification: 8:19-cv-01457, C.D. Cal., 07/30/2019
• Venue Allegations: Venue is alleged to be proper as Defendants reside in, have committed acts of infringement in, and maintain a regular and established place of business in the Central District of California.
• Core Dispute: Plaintiff alleges that Defendants’ Ovation family of abdominal stent graft systems infringes three patents related to endovascular stent/graft assemblies featuring an end-to-end connection between the stent and graft components.
• Technical Context: The technology concerns medical devices used for the endovascular repair of vascular anomalies, particularly abdominal aortic aneurysms, which can be fatal if left untreated.
• Key Procedural History: The complaint alleges that Defendants have had knowledge of Dr. Kerr's patent rights since at least 2010. Specific notice was allegedly provided via a letter to TriVascular Technologies, Inc. on or about December 11, 2015 regarding the '182 Patent, and another letter to an Endologix representative on or about June 29, 2017 asserting that the Ovation products infringe the '423 and '182 Patents. The complaint also references a meeting in early 2018 regarding the patent portfolio, after which Defendants allegedly refused to take a license.

Case Timeline

Date	Event
2001-04-11	Earliest Patent Priority Date ('423, '182, '209 Patents)
2012-09-04	U.S. Patent No. 8,257,423 Issues
2012-10-05	FDA grants premarket approval for Ovation Abdominal Stent Graft System
2012-12-11	FDA grants premarket approval for Ovation Prime Abdominal Stent Graft System
2015-06-09	U.S. Patent No. 9,050,182 Issues
2015-07-17	FDA grants premarket approval for Ovation iX Abdominal Stent Graft System
2015-12-11	Plaintiff sends letter to TriVascular notifying it of the '182 Patent
2017-06-29	Plaintiff sends letter to Endologix asserting infringement by Ovation products
2018-10-23	U.S. Patent No. 10,105,209 Issues
2019-07-30	Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,257,423 - "Stent/Graft Assembly," issued September 4, 2012

The Invention Explained

• Problem Addressed: The patent describes prior art endovascular stent/graft assemblies as having coaxial and longitudinally coextensive components. This arrangement results in a "cross-sectionally large assembly" that can be difficult to insert and deliver intravascularly, potentially requiring surgery rather than a less invasive procedure (’423 Patent, col. 2:19-27).
• The Patented Solution: The invention is an assembly where a tubular graft and a fixation device (e.g., a stent) are connected in a "substantially end-to-end relationship with little or no longitudinal overlap" (’423 Patent, col. 2:47-48). This design creates a device with a smaller cross-section, or "low profile," which can be introduced more easily into a patient's vasculature to bridge an aneurysm (’423 Patent, Abstract; col. 2:40-41). The connection is maintained by hooks extending from the stent to a ring on the graft (’423 Patent, col. 9:15-38).
• Technical Importance: The low-profile design facilitated by the end-to-end connection enables less invasive endovascular treatment for a wider range of patients with vascular anomalies (Compl. ¶¶ 17, 20).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claim 2 (Compl. ¶41).
• Essential elements of independent claim 1 include:
  • A substantially tubular stent means for directly contacting a healthy section of a blood vessel.
  • A substantially tubular graft means for bridging a damaged section of the blood vessel.
  • The graft means and stent means are fixedly disposed in a "substantially end-to-end connection without overlap."
  • Hooks connected to the downstream end of the stent means.
  • A ring means attached to the graft means and connected to the hooks to maintain the end-to-end connection.
  • Wherein the graft means has a smaller cross-section than a connection with overlap, allowing it to be introduced more easily.

U.S. Patent No. 9,050,182 - "Stent/Graft Assembly," issued June 9, 2015

The Invention Explained

• Problem Addressed: Like its parent, the ’182 Patent addresses the challenge of delivering bulky prior art stent/graft assemblies through blood vessels (’182 Patent, col. 2:20-27).
• The Patented Solution: The patent discloses a stent/graft assembly with an "immediately adjacent or abutting end-to-end" connection that avoids overlap (’182 Patent, Claim 14). The solution specifically claims a flexible graft where "substantially the entirety of the graft" is "unsupported by any framework," connected to a stent via a "plurality of wires" that extend from a "discrete ring" affixed to the graft. The ring is configured to keep the graft open "without encircling the stent," contributing to the device's low profile and flexibility (’182 Patent, Abstract; col. 2:44-67).
• Technical Importance: This specific structural arrangement of an unsupported graft, non-encircling ring, and connecting wires aims to provide a highly flexible, low-profile device for aneurysm repair.

Key Claims at a Glance

• The complaint asserts claims 1-17 and 19-21, with a focus on independent claim 14 (Compl. ¶¶ 56, 60).
• Essential elements of independent claim 14 include:
  • A substantially tubular stent with first and second axial ends.
  • A substantially tubular graft with a flexible wall, where "substantially the entirety of the graft being unsupported by any framework."
  • A "discrete ring" affixed to the graft's first axial end, configured to keep the graft open "without encircling the stent."
  • A "plurality of wires" extending from the ring and connecting to the stent's second axial end.
  • An "immediately adjacent or abutting end-to-end axial connection without overlap" between the stent and graft.

Multi-Patent Capsule: U.S. Patent No. 10,105,209

• Patent Identification: U.S. Patent No. 10,105,209, "Stent/Graft Assembly," issued October 23, 2018 (Compl. ¶13).
• Technology Synopsis: The '209 Patent also addresses the problem of large, difficult-to-deliver prior art devices (’209 Patent, col. 2:30-36). The patented solution refines the end-to-end connection concept by claiming a "non-abutting connection defining a small axial gap" between the stent and the graft. This connection is achieved by "a plurality of axially projecting extensions comprising wires or hooks" that extend from a discrete ring on the graft to the stent (’209 Patent, Claim 1).
• Asserted Claims: Claims 1-9 are asserted (Compl. ¶71).
• Accused Features: The complaint alleges that the Ovation Devices' stent, graft, discrete ring, and connecting "wires or hooks" infringe this patent by creating the claimed non-abutting, end-to-end connection (Compl. ¶¶ 75-76).

III. The Accused Instrumentality

• Product Identification: The accused products are the Ovation Abdominal Stent Graft System, the Ovation Prime Abdominal Stent Graft System, and the Ovation iX Abdominal Stent Graft System, collectively referred to as the "Ovation Devices" (Compl. ¶3).
• Functionality and Market Context: The Ovation Devices are described as endovascular stent/graft assemblies intended for repairing abdominal aortic aneurysms (Compl. ¶¶ 21, 23, 25). The complaint alleges these devices feature a modular, tubular bifurcated graft, a tubular stent, hooks connected to the stent, and a structural ring attached to the graft (Compl. ¶¶ 46, 61). A key functionality alleged is the connection mechanism between the stent and graft, which purportedly creates an end-to-end connection with no overlap, resulting in a system with an "ultra low profile" that is "less invasive" (Compl. ¶¶ 46, 61). The complaint provides an annotated photograph of an Ovation Device showing the separate stent and graft components prior to full assembly (Compl. ¶46, p. 10).

IV. Analysis of Infringement Allegations

'423 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a substantially tubular stent means for directly contacting said first relatively healthy section of said blood vessel...	The Ovation Devices include a tubular stent (A) with upstream and downstream axial ends, configured to contact the healthy vessel section upstream of an aneurysm.	¶46	col. 8:5-12
a substantially tubular graft means...having at least two branches...	The Ovation Devices include a modular bifurcated graft with an "aortic body section" and two "iliac limb" sections (S, T) that contact healthy vessel sections and bridge the aneurysm.	¶46	col. 8:13-27
said upstream end of the graft means being fixedly disposed with respect to the downstream axial end of the stent means in a substantially end-to-end connection without overlap;	The Ovation Devices allegedly include a structure that affixes the upstream end of the graft (B) to the downstream end of the stent (A) in an end-to-end connection without overlap (O).	¶46	col. 8:28-37
hooks fixedly connected with the downstream end of the stent means and extending at least to the upstream end of the graft means;	The Ovation Devices are alleged to include a plurality of hooks (K) connected to the downstream end of the stent (A) that extend to the upstream end of the graft (B).	¶46	col. 9:19-22
a ring means fixedly attached to the tubular graft means...the ring means further being connected to the hooks for maintaining the stent means and the graft means in said substantially end-to-end connection...	The Ovation Devices include a ring (R) attached to the graft and connected to the hooks (K) to maintain the end-to-end connection. A close-up annotated image illustrates this connection (Compl. ¶46, p. 12).	¶46	col. 9:28-38
wherein the graft means has a smaller cross-section than a connection with overlap...	The lack of overlap is alleged to result in a smaller cross-section, which Defendant touts as an "ultra low profile" and "less invasive" system.	¶46	col. 9:43-50

• Identified Points of Contention:
  • Scope Questions: Claim 1 uses means-plus-function language ("stent means," "graft means," "ring means"). A central dispute may be whether the specific structures in the Ovation Devices are the same as or structurally equivalent to the corresponding structures disclosed in the '423 Patent specification for performing the recited functions, as required under 35 U.S.C. § 112(f).
  • Technical Questions: What is the precise nature of the connection between the accused hooks and ring? The analysis may focus on whether this connection performs the claimed function of "maintaining the stent means and the graft means in said substantially end-to-end connection."

'182 Patent Infringement Allegations

Claim Element (from Independent Claim 14)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a substantially tubular stent having opposite first and second axial ends;	The Ovation Devices include a tubular stent (A) with opposite first (P) and second (Q) axial ends.	¶61	col. 2:44-46
a substantially tubular graft...substantially the entirety of the graft being unsupported by any framework;	The Ovation Devices include a tubular graft with first (B) and second (C) axial ends and a flexible wall (D), alleged to be unsupported by any framework.	¶61	col. 2:44-46
a discrete ring affixed to the graft...and configured to keep the tubular graft open without encircling the stent;	A discrete ring (R) is allegedly affixed to the graft near its first axial end (B). The complaint's annotated figures purport to show that this ring does not encircle the stent (A).	¶61	col. 2:58-61
a plurality of wires extending from the ring and connected to the second axial end of the stent...	The Ovation Devices allegedly include a plurality of hooking structures (K), described as wires, that extend from the ring (R) and connect to the second axial end (A) of the stent.	¶61	col. 2:62-65
wherein the stent and the graft have an immediately adjacent or abutting end-to-end axial connection without overlap between the stent and the graft.	The complaint alleges the connection between the stent (A) and graft (B) is an immediately adjacent or abutting end-to-end connection with no overlap (O).	¶61	col. 2:47-50

• Identified Points of Contention:
  • Scope Questions: Does the term "framework" encompass minor structural elements like reinforcing stitching or thickened fabric sections, or is it limited to a more substantial, stent-like support structure? The resolution of this question will determine if the accused graft is truly "unsupported."
  • Technical Questions: What is the specific composition and structure of the accused graft material? A key evidentiary question will be whether the accused graft's construction includes any elements that could be construed as a "framework" under the court's definition of that term.

V. Key Claim Terms for Construction

• The Term: "substantially end-to-end connection without overlap" ('423 Patent, Claim 1) / "immediately adjacent or abutting end-to-end axial connection without overlap" ('182 Patent, Claim 14)

• Context and Importance: This concept is central to the asserted patents' claim of providing a "low profile" device. The definition will determine whether the accused Ovation Devices, which are alleged to achieve their low profile through such a connection, fall within the scope of the claims. Practitioners may focus on this term because the '209 Patent, from the same family, explicitly claims a "non-abutting connection defining a small axial gap," which suggests the patentee may view a small gap as distinct from an "abutting" or simple "end-to-end" connection.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specifications contrast the invention with prior art that has significant longitudinal overlap for suturing ('423 Patent, col. 2:7-15). Language stating the goal is to have "little or no longitudinal overlap" ('423 Patent, col. 2:47-48) may support a construction where any connection that is not a substantial coaxial overlap meets the limitation.
  • Evidence for a Narrower Interpretation: The '423 Patent specification depicts a "true end-to-end axial connection" where components are "butted against" each other as one embodiment ('423 Patent, Fig. 2; col. 8:33-37) but also describes an alternative with "a slight amount of telescoping (e.g. 0-20 mm)" ('423 Patent, col. 3:9-11). A defendant may argue that "without overlap" requires a strict butt-joint or a defined gap, and that the accused device's connection does not meet this narrow definition.

• The Term: "unsupported by any framework" ('182 Patent, Claim 14)

• Context and Importance: This limitation defines the flexible and collapsible nature of the graft component. The infringement analysis for this element will depend entirely on how broadly or narrowly "framework" is defined and the specific construction of the accused grafts.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent does not explicitly define "framework." A broad interpretation, consistent with the patent's overall goal of flexibility, might construe "framework" to mean a rigid or semi-rigid structure akin to a stent that provides substantial, continuous radial support, as distinguished from the flexible fabric of the graft itself.
  • Evidence for a Narrower Interpretation: Without a specific definition, a defendant could argue that "framework" should be given its plain and ordinary meaning, which might encompass any supporting structure, including integrated reinforcing elements, wires, or polymers within the graft fabric that are not part of the primary textile weave.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement against all defendants for all three patents. The allegations are based on Defendants intentionally developing, marketing, and providing the Ovation Devices with the knowledge and specific intent that third parties, such as physicians and hospitals, will use them for their intended and infringing purpose of abdominal aortic repair (Compl. ¶¶ 47, 62, 77). The complaint cites Defendants' websites as evidence of this encouragement (Compl. ¶47).
• Willful Infringement: The complaint alleges willful infringement for all patents. The basis for willfulness is alleged pre-suit knowledge of the patent portfolio since at least 2010, specific written notice of the '182 Patent in December 2015, written notice of infringement for the '423 and '182 Patents in June 2017, and Defendants' continued infringing conduct after these notices and a subsequent meeting (Compl. ¶¶ 33-39, 54, 69, 84).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of definitional scope: how will the court construe the critical phrase "without overlap" as used in the '423 and '182 Patents? The case may turn on whether this term can encompass a connection with a small axial gap, as is explicitly claimed in the later '209 Patent, or if it requires a direct, abutting contact that may not be present in the accused devices.
• A key question for the '423 Patent will be one of structural equivalence: under the means-plus-function framework, are the specific hook-and-ring structures of the accused Ovation Devices structurally equivalent to the corresponding connecting structures disclosed in the '423 Patent's specification for maintaining the end-to-end connection?
• An essential evidentiary question will be one of technical construction: is the flexible graft of the accused Ovation Devices truly "unsupported by any framework" as required by the '182 and '209 Patents? This will likely require expert analysis of the device's material composition and construction to determine if any integrated elements constitute a "framework" under the court's claim construction.