DCT
4:22-cv-03072
Recor Medical Inc v. Medtronic Ireland Mfg UnLtd Co
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ReCor Medical, Inc. (Delaware)
- Defendant: Medtronic Ireland Manufacturing Unlimited Co. (Ireland) and Medtronic Vascular, Inc. (Delaware)
- Plaintiff’s Counsel: Latham & Watkins LLP
- Case Identification: 4:22-cv-03072, N.D. Cal., 05/25/2022
- Venue Allegations: Venue is asserted based on allegations that Defendant Medtronic Vascular, Inc. has a principal place of business in the district; that threats of enforcement were directed into the district; that the accused product was developed and is manufactured in the district; and that four named inventors of the patent-in-suit reside in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its Paradise Renal Denervation System does not infringe Defendant's patent related to ultrasound-based renal neuromodulation, and that the patent is invalid.
- Technical Context: The technology involves catheter-based systems that use energy to modulate nerves surrounding the renal arteries as a minimally invasive treatment for hypertension.
- Key Procedural History: This declaratory judgment action was filed after Defendant Medtronic filed a suit in Germany against Plaintiff ReCor on a related European patent and sent a letter to ReCor notifying it of the German action. The complaint also references an earlier related case filed in the same district and makes detailed allegations of invalidity based on prior art and obviousness-type double patenting over other patents in the same family.
Case Timeline
| Date | Event |
|---|---|
| 2004-10-05 | ’629 Patent - Earliest Priority Date |
| 2014-09-30 | ’629 Patent - Issue Date |
| 2020-03-01 | Medtronic's Symplicity Catheter Receives FDA Breakthrough Device Designation (approx.) |
| 2020-12-10 | ReCor’s Paradise System Receives FDA Breakthrough Device Designation (approx.) |
| 2021-11-22 | Medtronic Files German Action Against ReCor on Related European Patent (approx.) |
| 2021-12-08 | Medtronic Notifies ReCor by Letter of German Action (approx.) |
| 2022-03-01 | ReCor Announces Completion of Enrollment in RADIANCE-II Clinical Study (approx.) |
| 2022-05-25 | Complaint for Declaratory Judgment Filed |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 8,845,629, "Ultrasound apparatuses for thermally-induced renal neuromodulation," issued September 30, 2014.
- The Invention Explained:
- Problem Addressed: The patent describes the challenge of treating conditions like hypertension that are exacerbated by overactive renal nerves. Specifically, it identifies the need for a method to selectively modulate these nerves, which are located outside the renal artery, without causing unwanted thermal damage to the artery's wall itself ('629 Patent, Background, col. 1:13-20, col. 2:44-50).
- The Patented Solution: The invention is a catheter-based apparatus designed to be placed inside the renal artery. It features an ultrasound transducer mounted on the catheter shaft and an expandable member, such as an inflatable balloon. The apparatus is configured to transmit ultrasound energy outward through the blood vessel wall to heat and modulate the target renal nerves, while simultaneously protecting the non-target tissue of the vessel wall from thermal injury, for instance by focusing the energy to a point outside the vessel ('629 Patent, Abstract; col. 14:53-58; Fig. 12B).
- Technical Importance: This technology offers a potential minimally invasive, vessel-based method to achieve renal denervation, a therapeutic strategy for controlling treatment-resistant hypertension and related cardio-renal diseases ('629 Patent, col. 1:50-55).
- Key Claims at a Glance:
- The complaint seeks a declaratory judgment of non-infringement of all claims of the ’629 Patent, with a focus on its single independent claim, Claim 1 (Compl. ¶¶19, 41).
- Independent Claim 1 of the ’629 Patent recites:
- a catheter sized and shaped for delivery within a blood vessel;
- an ultrasound transducer carried by the catheter, configured to transmit ultrasound energy waves to target renal neural fibers outside the blood vessel to thermally induce modulation while protecting non-target tissue in the vessel wall from thermal injury; and
- an expandable member carried by the catheter, wherein the transducer is positioned on the catheter shaft and within the expandable member.
- The complaint also raises invalidity challenges against dependent claims 1-4 and 8-12, indicating a dispute over more specific features disclosed in the patent (Compl. ¶47).
III. The Accused Instrumentality
- Product Identification: The ReCor Medical Paradise Renal Denervation System ("the Paradise System") (Compl. ¶6).
- Functionality and Market Context:
- The Paradise System is described as a minimally invasive procedure to treat hypertension by delivering heat to tissue surrounding the renal artery (Compl. ¶¶8, 12).
- The system uses a catheter inserted into the renal artery that delivers heat via "pulses of unfocused ultrasound energy" (Compl. ¶13).
- A key feature alleged in the complaint is the use of "circulating water within the Paradise System" which "cools the surrounding arterial tissue to protect it from the heat generated by the ultrasound pulses" (Compl. ¶14).
- The complaint notes that the Paradise System has received CE mark approval for sale in Europe and FDA Breakthrough Device Designation in the U.S., positioning it as a competitor to Defendant's own radiofrequency-based renal denervation system (Compl. ¶¶12, 13, 15).
No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
The complaint seeks a declaratory judgment of non-infringement. The table below summarizes the plaintiff's (ReCor's) primary arguments for why its Paradise System does not meet specific limitations of the ’629 Patent's claims.
| Claim Element (from Independent Claim 1 and Dependent Claim 5) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| "wherein the ultrasound transducer is configured to transmit ultrasound energy waves to target renal neural fibers outside of the blood vessel" (from Claim 1) | The Paradise System employs unfocused ultrasound that does not target renal neural fibers. | ¶42 | col. 16:11-13 |
| "...while protecting non-target tissue in the blood vessel wall from thermal injury" (from Claim 1) | The Paradise System protects the arterial wall using a distinct mechanism of circulating cooling water. | ¶14 | col. 16:15-17 |
| "the acoustically reflective portion and the acoustically transmissive portion are configured to transmit...ultrasound energy waves to a focal distance point proximate to the target neural fibers" (from Dep. Claim 5) | The Paradise System does not transmit ultrasound energy waves to a focal distance point. | ¶42 | col. 16:38-42 |
- Identified Points of Contention:
- Scope Questions: A primary dispute concerns the interpretation of "target." The complaint alleges the accused product uses "unfocused" ultrasound, which it argues does not "target" neural fibers as required by the claim (Compl. ¶42). The case may turn on whether the term "target" requires the energy to be focused, a feature explicitly described in embodiments and dependent claims of the patent, or if it can be read more broadly to mean any application of energy intended to affect the nerves.
- Technical Questions: The complaint creates a clear technical distinction by alleging its system uses "unfocused" ultrasound and active water-cooling for protection (Compl. ¶¶13-14). This is contrasted with the patent's disclosure of using a balloon with reflective surfaces to focus ultrasound and thereby create a "reverse thermal gradient" that protects the vessel wall ('629 Patent, col. 14:53-60). The court will need to assess whether these are fundamentally different technical approaches. The complaint's specific reference to non-infringement of a limitation from dependent claim 5 ("focal distance point") underscores this as a central point of contention (Compl. ¶42).
V. Key Claim Terms for Construction
The Term: "configured to transmit ultrasound energy waves to target renal neural fibers"
Context and Importance: This term is at the center of the non-infringement dispute. Practitioners may focus on this term because ReCor's entire non-infringement theory is built on its allegation that its "unfocused" ultrasound does not "target" fibers in the way the patent claims (Compl. ¶42). The construction will determine whether a lack of a focusing mechanism, as alleged, takes the Paradise System outside the scope of the claim.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The plain language of independent claim 1 does not explicitly recite "focusing." A party could argue that any device designed and used to deliver energy to the renal nerves is inherently "configured to target" them, irrespective of the beam's specific geometry.
- Evidence for a Narrower Interpretation: The specification repeatedly links the therapeutic effect to focused energy. The detailed description of Figure 12B explains how an "acoustically reflective portion" of a balloon is used to focus the wave to a "focal point" ('629 Patent, col. 14:25-41). The language of dependent claim 5, which explicitly adds a "focal distance point," could be used to argue that "targeting" in the context of the patent implies such directed energy.
The Term: "protecting non-target tissue in the blood vessel wall from thermal injury"
Context and Importance: This functional language is critical because the parties' technologies allegedly achieve this protective result through different mechanisms. The court’s construction will determine if the claim covers any method of protection or is limited to the method disclosed in the specification.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language is written in broad functional terms, stating a result ("protecting") without specifying a structure or method for achieving it. This may support an interpretation that covers any means of protection, including the active cooling allegedly used by the accused product (Compl. ¶14).
- Evidence for a Narrower Interpretation: The patent specification links the "protecting" function directly to the act of focusing the ultrasound. It teaches that focusing the wave creates a "reverse thermal gradient," where the vessel wall temperature is lower than the target tissue temperature ('629 Patent, col. 14:53-60). This could support an argument that the claim is limited to this inherent protective mechanism, and does not cover protection via an extrinsic element like circulating cooling water.
VI. Other Allegations
- Indirect Infringement: The plaintiff seeks a declaratory judgment that it has not infringed any claim of the ’629 Patent indirectly (Compl. ¶41). The complaint does not set forth a separate factual basis for non-infringement of the indirect claims, relying instead on its argument that there is no underlying direct infringement.
- Willful Infringement: Not applicable, as this is a complaint for declaratory judgment of non-infringement.
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action presents several key questions for the court that will define the scope of the dispute:
- A core issue will be one of claim construction: does the term "configured to... target renal neural fibers" require the focused, directed application of ultrasound energy described in the patent's specific embodiments, or can it be construed more broadly to cover the "unfocused ultrasound" allegedly employed by the accused Paradise System?
- A central infringement question will be one of technical and functional divergence: does the accused system, which allegedly protects the artery wall via active "circulating water" cooling, operate in a manner covered by the claim limitation "protecting non-target tissue," or is that limitation implicitly tied to the patent's disclosed mechanism of using a focused energy beam to create a protective thermal gradient?
- Finally, the case presents a preemptive challenge to patent validity, raising the question of whether the ’629 Patent's claims are anticipated or rendered obvious by the prior art patents cited in the complaint, or are invalid for obviousness-type double patenting over other Medtronic patents.