DCT
4:22-cv-00236
ReCor Medical Inc v. Medtronic Ardian Luxembourg SARL
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ReCor Medical, Inc. (Delaware)
- Defendant: Medtronic Ardian Luxembourg S.à.r.l. (Luxembourg) and Medtronic Vascular, Inc. (Delaware)
- Plaintiff’s Counsel: Latham & Watkins LLP
- Case Identification: 4:22-cv-00236, N.D. Cal., 01/13/2022
- Venue Allegations: Plaintiff ReCor alleges venue is proper in the Northern District of California because Defendant Medtronic Vascular has its headquarters in Santa Rosa, CA, from which it allegedly directed threats of enforcement to ReCor’s headquarters in Palo Alto, CA. It is also alleged that four inventors of the patent-in-suit reside in and conducted work within the district.
- Core Dispute: Plaintiff ReCor seeks a declaratory judgment that its Paradise System, a medical device for treating hypertension, does not infringe Defendant Medtronic's patent related to ultrasound-based renal neuromodulation, and further that Medtronic's patent is invalid.
- Technical Context: The technology involves renal denervation—using energy to modulate nerves surrounding the renal arteries—as a minimally invasive treatment for hypertension, a significant cardiovascular risk factor.
- Key Procedural History: The complaint states that this U.S. action was precipitated by Medtronic filing a patent infringement suit against ReCor in Germany on November 22, 2021, asserting a related European patent. Subsequent communications, including a letter from Medtronic and a response from Medtronic’s counsel referencing a potential "compensation package" for infringement, are alleged to have created a substantial risk of a U.S. lawsuit, prompting this declaratory judgment action.
Case Timeline
| Date | Event |
|---|---|
| 2004-10-05 | Earliest Priority Date for ’629 Patent |
| 2014-09-30 | U.S. Patent No. 8,845,629 Issues |
| 2020-03-01 | Medtronic announces FDA Breakthrough Device Designation for its Symplicity Catheter (approximate date) |
| 2020-12-10 | ReCor announces FDA Breakthrough Device Designation for its Paradise System |
| 2021-11-22 | Medtronic files patent infringement action against ReCor in Germany |
| 2021-12-08 | Medtronic sends letter to ReCor regarding the German action |
| 2022-01-13 | ReCor files Complaint for Declaratory Judgment in N.D. Cal. |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,845,629 - "Ultrasound apparatuses for thermally-induced renal neuromodulation"
The Invention Explained
- Problem Addressed: The patent addresses the challenge of performing renal denervation to treat conditions like hypertension, where a key difficulty is selectively modulating the target renal nerves without causing unwanted thermal damage to surrounding non-target tissue, such as the smooth muscle cells of the blood vessel wall (’629 Patent, col. 2:44-54).
- The Patented Solution: The invention proposes an intravascular apparatus that uses ultrasound energy to thermally modulate renal nerves located outside the blood vessel. A key embodiment describes an ultrasound transducer positioned on a catheter shaft within an expandable balloon; the balloon can have an acoustically reflective surface to help focus the ultrasound energy to a point outside the vessel, thereby heating the target nerves while creating a "reverse thermal gradient" that helps protect the vessel wall from thermal injury (’629 Patent, Abstract; col. 14:45-61; Fig. 12B).
- Technical Importance: This approach sought to provide a more precise method of energy delivery for renal denervation, aiming to increase efficacy on nerve tissue while enhancing the safety profile by minimizing damage to the adjacent renal artery (’629 Patent, col. 2:44-54).
Key Claims at a Glance
- The complaint asserts non-infringement of all claims of the patent, with a focus on the single independent claim, Claim 1 (Compl. ¶¶ 18, 40).
- Independent Claim 1 requires:
- A catheter for delivery within a blood vessel.
- An ultrasound transducer on the catheter configured to transmit ultrasound energy waves "to target renal neural fibers outside of the blood vessel."
- The transducer must also be configured for "protecting non-target tissue in the blood vessel wall from thermal injury."
- An expandable member on a distal region of the catheter.
- The ultrasound transducer is positioned on the catheter shaft and "within the expandable member."
- The complaint notes that ReCor seeks a declaratory judgment that it does not infringe any claims, directly or indirectly (Compl. ¶40).
III. The Accused Instrumentality
Product Identification
- The "Paradise Renal Denervation System" ("Paradise System") (Compl. ¶5).
Functionality and Market Context
- The Paradise System is a catheter-based device for treating hypertension. It is inserted into the renal artery and "delivers heat to the tissue surrounding the artery using pulses of unfocused ultrasound energy" (Compl. ¶7).
- A distinguishing technical feature alleged in the complaint is a system for circulating water within the device to cool the surrounding arterial tissue, protecting it from the heat generated by the ultrasound (Compl. ¶¶ 7, 10-11).
- The complaint positions the Paradise System as a direct competitor to Medtronic's own "Symplicity System," which uses radiofrequency energy instead of ultrasound. Both products have received FDA Breakthrough Device Designation, highlighting their potential clinical significance and the competitive nature of the market (Compl. ¶¶ 14-16).
IV. Analysis of Infringement Allegations
This is a declaratory judgment action where the Plaintiff (ReCor) alleges non-infringement. The following table summarizes ReCor's central arguments for why its Paradise System does not meet the limitations of the asserted patent claim.
’629 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an ultrasound transducer ... configured to transmit ultrasound energy waves to target renal neural fibers outside of the blood vessel | The Paradise System employs "unfocused ultrasound that does not target renal neural fibers." | ¶41 | col. 15:10-14 |
| to thermally induce modulation of target neural fibers while protecting non-target tissue in the blood vessel wall from thermal injury | The Paradise System protects non-target tissue via an active cooling mechanism (circulating water), which is a different method of protection than that described in the patent. | ¶7 | col. 15:14-17 |
| an expandable member carried by a distal region of the catheter ... wherein the ultrasound transducer is positioned on a shaft of the catheter and within the expandable member | The complaint does not provide sufficient detail for analysis of this element. | col. 15:18-24 |
No probative visual evidence provided in complaint.
- Identified Points of Contention:
- Scope Questions: The central dispute appears to be one of claim scope and definition. Does the claim term "to target" require the directed, focused energy delivery shown in the patent's preferred embodiments (e.g., using a reflective balloon to create a focal point), or can it be read more broadly to include the "unfocused" energy that ReCor’s device allegedly emits in the general direction of the nerves?
- Technical Questions: A key technical question is whether there is a fundamental difference between the method of "protecting non-target tissue" described in the patent (e.g., a "reverse thermal gradient" created by focused ultrasound) and the active water-cooling system used by the accused Paradise System. The court may need to determine if ReCor's cooling mechanism is a distinct, non-infringing alternative or simply a different way of achieving the same claimed function.
V. Key Claim Terms for Construction
The Term: "to target renal neural fibers outside of the blood vessel"
Context and Importance: This term is the crux of ReCor's non-infringement argument. ReCor contends its use of "unfocused" ultrasound does not meet this limitation. The construction of "to target" will therefore be critical in determining whether an infringement can occur.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: Medtronic may argue that "to target" does not exclusively mean "to focus." It could be interpreted functionally, meaning the energy is directed in such a way that it affects the intended nerves, regardless of the specific mechanism. The patent's general description refers to transmitting energy "to target neural fibers" without always specifying focusing (’629 Patent, col. 4:51-53).
- Evidence for a Narrower Interpretation: ReCor may point to specific embodiments in the patent that achieve targeting through highly specific focusing mechanisms. For instance, the specification repeatedly describes using a reflective balloon to direct ultrasound waves "to a focal point or radius P positioned a desired focal distance from the catheter shaft" to affect nerves "outside of the vessel" (’629 Patent, col. 14:45-51; Fig. 12B). This could support an argument that "to target" requires such a focusing capability, which ReCor alleges its device lacks (Compl. ¶41).
The Term: "protecting non-target tissue in the blood vessel wall"
Context and Importance: The patent and the complaint describe different methods for achieving this protection. The patent emphasizes protection inherent in the energy delivery method (e.g., a reverse thermal gradient from focused ultrasound), while the complaint describes an active cooling system. This difference may be a key point of dispute.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is functional. Medtronic could argue that any apparatus that performs the function of "protecting" the vessel wall meets this limitation, irrespective of the specific mechanism (e.g., inherent gradient or active cooling).
- Evidence for a Narrower Interpretation: ReCor may argue that the specification links the "protecting" function directly to the use of focused ultrasound. For example, it states, "Focusing the ultrasound wave may produce a reverse thermal gradient that protects the non-target tissues" (’629 Patent, col. 14:52-54). This could support a construction where the protection must be achieved by the specific ultrasound modality claimed, not by an extrinsic feature like a water-cooling circuit.
VI. Other Allegations
- Indirect Infringement: ReCor seeks a declaratory judgment that it does not indirectly infringe the ’629 Patent, but the complaint does not provide specific facts or arguments related to inducement or contributory infringement beyond a general denial of any infringing acts (Compl. ¶40).
- Willful Infringement: As this is a declaratory judgment action filed by the accused infringer, there is no allegation of willful infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this declaratory judgment action will likely depend on the court's determination of two central questions:
A core issue will be one of definitional scope: Can the claim phrase "to target renal neural fibers" be construed to read on the "unfocused ultrasound" allegedly used by ReCor's Paradise System? The outcome will likely turn on whether "to target" requires a specific focusing mechanism, as detailed in the patent's embodiments, or if it can encompass a more general, non-focused delivery of energy toward the nerves.
A second key issue will be one of functional distinction: Does the claim limitation "protecting non-target tissue" require the protection to be an inherent property of the ultrasound delivery, such as the "reverse thermal gradient" described in the patent, or can it be satisfied by an auxiliary mechanism like the active water-cooling system of the accused product? This will test the boundary between claimed functionality and a potentially non-infringing design-around.