DCT
2:19-cv-10041
Integrated Sensing Systems Inc v. Abbott Laboratories
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Integrated Sensing Systems, Inc. (Michigan)
- Defendant: Abbott Laboratories (Illinois), St. Jude Medical, LLC (Delaware), and CardioMEMS LLC (Delaware)
- Plaintiff’s Counsel: Brinks Gilson & Lione
- Case Identification: 2:19-cv-10041, E.D. Mich., 01/04/2019
- Venue Allegations: Plaintiff alleges venue is proper because Defendants have a regular and established place of business in the district through a subsidiary, have sales representatives in Michigan, and have conducted clinical trials in the state.
- Core Dispute: Plaintiff alleges that Defendants’ CardioMEMS HF System, an implantable heart failure monitor, infringes a patent related to wireless micro-electromechanical system (MEMS) sensors.
- Technical Context: The technology concerns battery-less, implantable sensors that wirelessly transmit physiological data (e.g., blood pressure) from deep within the body to an external reader.
- Key Procedural History: The complaint alleges that Plaintiff notified Defendant Abbott Labs of the patent-in-suit and its belief that the accused product infringed during licensing and acquisition discussions in 2015, prior to Abbott’s acquisition of the product line. An Inter Partes Review (IPR) certificate, included with the patent documents, indicates that the primary asserted claim in this complaint, Claim 1, along with claims 2-5, 21-29, and 31 of the patent-in-suit, were cancelled in a subsequent proceeding concluded on May 14, 2021.
Case Timeline
| Date | Event |
|---|---|
| 2001-01-22 | ’670 Patent Priority Date |
| 2005-08-09 | ’670 Patent Issue Date |
| 2011-XX-XX | Plaintiff and Abbott Labs allegedly begin licensing discussions |
| 2013-06-XX | Plaintiff begins human clinical trials of its own patented system |
| 2014-05-XX | St. Jude Medical acquires CardioMEMS LLC |
| 2014-11-XX | Plaintiff and Abbott Ventures allegedly begin discussions |
| 2015-10-21 | Plaintiff allegedly informs Abbott Labs of ’670 Patent and alleged infringement by CardioMEMS HF System |
| 2016-04-20 | Abbott Labs announces acquisition of St. Jude Medical |
| 2018-03-29 | Abbott Labs announces GUIDE-HF clinical trial for accused product |
| 2019-01-04 | Complaint Filing Date |
| 2019-07-15 | IPR proceedings initiated against the ’670 Patent |
| 2021-05-14 | IPR certificate issues, cancelling asserted Claim 1 |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,926,670 - "Wireless MEMS Capacitive Sensor for Physiologic Parameter Measurement," issued August 9, 2005
The Invention Explained
- Problem Addressed: The patent’s background section identifies the challenge of creating wireless sensors that can be implanted deep within the body (e.g., in a heart ventricle) and reliably communicate with an external reader. Prior art sensors were limited to very short separation distances (1-2 cm) due to factors like signal attenuation by tissue and inefficient magnetic coupling (’670 Patent, col. 3:1-9).
- The Patented Solution: The invention proposes a "monolithic" implantable sensor fabricated on a single substrate, where a capacitive sensor and an "integrated inductor" are built together as a single micro-electromechanical system (MEMS) device (’670 Patent, col. 4:48-54). This inductor is specifically designed with a magnetic core that optimizes magnetic coupling efficiency, which in turn allows for a greater communication distance between the implant and an external reader, overcoming the distance limitations of prior art (’670 Patent, col. 7:6-15; Fig. 3). The inductor and the pressure-sensitive capacitor form an LC tank resonator, whose resonant frequency changes with pressure and can be detected wirelessly without needing an internal power source (’670 Patent, Abstract).
- Technical Importance: This integrated, battery-less design aimed to enable safe, long-term monitoring of physiological parameters like blood pressure in locations that were previously impractical for wireless sensors (’670 Patent, col. 1:60-65).
Key Claims at a Glance
- The complaint asserts infringement of "at least claim 1" of the ’670 Patent (Compl. ¶32).
- Independent Claim 1 requires:
- An implantable microfabricated sensor device for measuring a physiologic parameter of interest within a patient, said sensor comprising:
- an implantable sensing device, said sensing device being a micro electromechanical system (MEMS) comprising a substrate,
- an integrated inductor formed on the substrate,
- at least one sensor responsive to the physiologic parameters and being formed at least in part on the substrate,
- a plurality of conductive paths electrically connecting said integrated inductor with said sensor,
- said integrated inductor, said sensor and said conductive paths cooperatively defining an LC tank resonator.
- The complaint’s phrasing "one or more claims" suggests the right to assert other claims may be reserved (Compl. ¶32).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the CardioMEMS HF System (Compl. ¶32).
Functionality and Market Context
- The CardioMEMS HF System is an implantable medical device designed for heart failure patients (Compl. ¶34). It is implanted in a patient's pulmonary artery to wirelessly measure and monitor pulmonary artery pressure and heart rate (Compl. ¶34-35). This data is used by physicians for heart failure management, with a stated goal of reducing hospitalizations (Compl. ¶34). The complaint alleges the product is a "Featured Product" in Defendants' portfolio and is positioned as an important tool for managing heart failure (Compl. ¶27, ¶29). A visual from the St. Jude Medical website shows the external monitoring unit being held over a patient's arm to read data from the implant. (Compl. ¶33).
IV. Analysis of Infringement Allegations
’670 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an implantable microfabricated sensor device | The CardioMEMS HF System is described as comprising "an implantable microfabricated sensor device for measuring a physiologic parameter of interest within a patient." | ¶33 | col. 13:22-24 |
| said sensing device being a micro electromechanical system (MEMS) comprising a substrate | The sensing device is alleged to be a MEMS device that "includes a substrate and an integrated inductor formed on the substrate." It is also described as comprising a capacitor encased between two wafers of fused silica. | ¶36, ¶37, ¶38 | col. 13:27-29 |
| an integrated inductor formed on the substrate | The device is alleged to include an "integrated inductor formed on the substrate," which is identified as an "inductor coil" in a product diagram. | ¶37, ¶38 | col. 13:30-31 |
| at least one sensor responsive to the physiologic parameters and being formed at least in part on the substrate | The device allegedly includes "at least one sensor formed at least in part on the substrate" that is a "pressure sensitive capacitor" responsive to a patient's physiologic parameters. | ¶38 | col. 13:32-34 |
| a plurality of conductive paths electrically connecting said integrated inductor with said sensor | The device is alleged to include a "plurality of conductive paths electrically connecting the integrated inductor with the sensor." | ¶39 | col. 13:35-37 |
| said integrated inductor, said sensor and said conductive paths cooperatively defining an LC tank resonator | The inductor, sensor, and paths are alleged to "cooperatively define an LC tank resonator," which changes resonant frequency based on blood pressure. A diagram shows this principle. | ¶39 | col. 13:38-40 |
- Identified Points of Contention:
- Scope Questions: A primary issue for the court would be whether the accused device's structure meets the claim limitations as understood in light of the patent's specification. For instance, the complaint describes the accused sensor as "a coil and a pressure sensitive capacitor encased between two (2) wafers of fused silica" (Compl. ¶38-39). This raises the question of whether this two-wafer assembly constitutes a singular "substrate" on which an "integrated inductor" is "formed," as those terms are used in the patent, which emphasizes a "monolithic device" ('670 Patent, col. 4:51).
- Technical Questions: The complaint alleges the device has an "integrated inductor" (Compl. ¶37), and a provided diagram labels an "INDUCTOR COIL" (Compl. p. 9). The patent, however, describes a specific inductor structure with a magnetic core to enhance performance ('670 Patent, col. 6:20-30). A key technical question will be what evidence demonstrates that the accused "inductor coil" has the structure and properties of the "integrated inductor" claimed in the patent.
V. Key Claim Terms for Construction
The Term:
"integrated inductor"Context and Importance: This term is at the heart of the invention's purported advance over the prior art—an inductor designed for high-efficiency magnetic coupling. Practitioners may focus on this term because its construction will determine whether a simple co-located coil (as may be present in the accused device) is sufficient to infringe, or if a more specific, structurally optimized component is required.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of the claim does not specify a particular structure for the inductor, only that it is "integrated" and "formed on the substrate." This could support an interpretation where any inductor fabricated as part of the overall sensor package meets the limitation.
- Evidence for a Narrower Interpretation: The specification repeatedly describes the preferred embodiment of the inductor as having a "magnetic core 33 defined by a top plate 36, a bottom plate 38 and a post 40" ('670 Patent, col. 6:20-25; Fig. 3). An argument could be made that "integrated inductor" is implicitly limited to this more complex structure, which the patent credits for achieving its objectives.
The Term:
"substrate"Context and Importance: The claims require both the inductor and the sensor to be "formed on the substrate." The physical nature of the accused device—a capacitor "encased between two (2) wafers of fused silica" (Compl. ¶38-39)—makes the definition of "substrate" critical for the infringement analysis.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is not explicitly defined, leaving open an argument that it could refer to the overall structural foundation of the MEMS device, which might include the combination of the two silica wafers.
- Evidence for a Narrower Interpretation: The specification refers to "a main substrate 34 (preferably 7740 Pyrex glass)" and a "common substrate 20," suggesting a single, unitary component upon which other elements are fabricated ('670 Patent, col. 6:17-18, col. 6:60). This could support a narrower construction that excludes a multi-part "encased" assembly.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement, stating that Defendants' marketing materials and website content instruct customers (e.g., hospitals and physicians) to use the CardioMEMS HF System in a manner that directly infringes, namely by implanting it to measure physiological parameters (Compl. ¶47). Contributory infringement is also alleged on the basis that the CardioMEMS HF System is a material component of the claimed invention, is not a staple article of commerce, and has no substantial non-infringing uses (Compl. ¶51).
- Willful Infringement: Willfulness is alleged based on pre-suit knowledge. The complaint specifically alleges that Plaintiff informed Defendant Abbott Labs of the ’670 Patent and of its belief that the CardioMEMS HF System infringed the patent during a meeting on October 21, 2015, well before the lawsuit was filed (Compl. ¶22, ¶23).
VII. Analyst’s Conclusion: Key Questions for the Case
- A threshold issue will be procedural and jurisdictional: given that the primary asserted claim (Claim 1) was cancelled in an IPR proceeding after the complaint was filed, a central question is what legal effect this cancellation has on the continuation of the case as pleaded.
- Assuming the case proceeds on other claims, a core issue will be one of claim construction: can the terms
"integrated inductor"and"substrate", as described in a patent focused on a "monolithic" device architecture, be construed to read on the accused product's structure, which is described as a sensor and coil "encased between two (2) wafers"? - A key factual question for damages will be one of willfulness: the complaint contains specific allegations of pre-suit notice of both the patent and the alleged infringement, raising a significant question for the fact-finder regarding the defendant's state of mind should infringement be found.