DCT
3:25-cv-05881
Medtronic Ireland Mfg UnLtd Co v. Recor Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Medtronic Ireland Manufacturing Unlimited Co. and Medtronic Vascular Galway Unlimited Co. (Ireland)
- Defendant: Recor Medical, Inc. (Delaware / California)
- Plaintiff’s Counsel: TURNER BOYD SERAPHINE LLP
- Case Identification: 3:25-cv-05881, N.D. Cal., 07/14/2025
- Venue Allegations: Venue is based on Defendant Recor Medical, Inc. having its headquarters and a regular and established place of business within the Northern District of California.
- Core Dispute: Plaintiff alleges that Defendant’s Paradise Ultrasound Renal Denervation System infringes patents related to catheter-based apparatuses and systems for thermally-induced renal neuromodulation.
- Technical Context: The technology is catheter-based renal denervation (RDN), a minimally invasive medical procedure used to treat resistant hypertension by applying energy to disrupt sympathetic nerves located around the renal arteries.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of U.S. Patent No. 8,845,629 ("the ’629 Patent") as of December 8, 2021, via a letter concerning a related German legal action. The complaint also references prior declaratory judgment actions filed by the Defendant against the Plaintiff on January 13, 2022, and May 25, 2022, indicating a history of legal disputes between the parties over the asserted technology. Knowledge of U.S. Patent No. 11,801,085 ("the ’085 Patent") is alleged as of June 3, 2024, based on the filing of counterclaims in a related action.
Case Timeline
| Date | Event |
|---|---|
| 2002-04-08 | ’629 Patent Priority Date |
| 2006-06-28 | ’085 Patent Priority Date |
| 2010-04-05 | ’629 Patent Application Filing Date |
| 2014-09-30 | ’629 Patent Issue Date |
| 2020-07-24 | ’085 Patent Application Filing Date |
| 2021-12-08 | Defendant allegedly notified of ’629 Patent via German Action letter |
| 2022-01-13 | Defendant files first related declaratory judgment action |
| 2022-05-25 | Defendant files second related declaratory judgment action |
| 2023-10-31 | ’085 Patent Issue Date |
| 2023-11-07 | Accused Product (Paradise System) receives FDA approval |
| 2024-06-03 | Defendant allegedly gains knowledge of ’085 Patent via counterclaim filing |
| 2025-07-14 | Complaint Filing Date |
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 selectively modulating target renal nerves to treat conditions like hypertension, while avoiding damage to non-target tissues such as the smooth muscle cells of the blood vessel wall through which treatment is administered (’629 Patent, col. 1:33-44).
- The Patented Solution: The invention is an apparatus, typically a catheter, equipped with an ultrasound transducer designed to be placed inside a renal blood vessel. The transducer transmits ultrasound energy outwards through the vessel wall to heat and modulate the target nerves located in the surrounding tissue, while features of the device are intended to protect the vessel wall itself from thermal injury (’629 Patent, Abstract; col. 8:8-17). The use of an expandable member, such as a balloon, helps position the transducer within the vessel (ʼ629 Patent, Fig. 4A).
- Technical Importance: This technology provides a method for catheter-based, minimally invasive renal denervation using ultrasound energy, which may offer a safer and more controlled alternative to previous surgical or less targeted energy-delivery approaches (Compl. ¶¶10-11).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 (Compl. ¶44).
- Essential elements of Claim 1 include:
- A catheter sized for delivery within a blood vessel.
- An ultrasound transducer carried by the catheter, configured to transmit energy to modulate target renal neural fibers outside the vessel.
- The transducer is configured to protect non-target tissue in the blood vessel wall from thermal injury.
- An expandable member carried by a distal region of the catheter, which can vary between a reduced delivery configuration and an expanded deployed configuration.
- The ultrasound transducer is positioned on the catheter's shaft and within the expandable member.
U.S. Patent No. 11,801,085 - "Devices For Thermally-Induced Renal Neuromodulation"
The Invention Explained
- Problem Addressed: The patent background describes the link between sympathetic renal nerve activity and conditions like congestive heart failure and hypertension, noting that the kidneys' reaction can "perpetuate a downward spiral of the heart failure condition" (’085 Patent, col. 2:4-6). This context suggests a need for effective and safe methods of performing renal denervation.
- The Patented Solution: The invention is a system for renal neuromodulation comprising a catheter with a neuromodulation element (e.g., an electrode or transducer) and a generator. A key feature is an "expandable positioning element" that is specifically "configured to receive a cooling fluid configured to remove heat from within the expandable positioning element" (’085 Patent, Abstract; col. 9:46-52). This integrated cooling mechanism is designed to protect non-target tissue, such as the artery wall, during the energy delivery process (’085 Patent, col. 5:4-9).
- Technical Importance: By explicitly integrating a cooling fluid system within the expandable positioning element, the invention aims to provide enhanced thermal protection for the blood vessel, which may allow for the safe delivery of higher or longer-duration energy fields to effectively ablate the target nerves (’085 Patent, col. 5:4-16).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 (Compl. ¶92).
- Essential elements of Claim 1 include:
- A system comprising a catheter, at least one neuromodulation element, and a generator.
- The generator is configured to generate and deliver energy sufficient to ablate renal neural fibers.
- An expandable positioning element carried by the catheter.
- The expandable positioning element is configured to receive a cooling fluid that is configured to remove heat from within the element.
- The distal portion of the system is configured for positioning in a renal blood vessel.
- The expandable element is transformable from a low-profile delivery state to an expanded state.
- In the expanded state, the neuromodulation element is spaced radially inward from the outer diameter of the expandable element.
III. The Accused Instrumentality
Product Identification
- The Accused Product is the "Paradise Ultrasound Renal Denervation System" ("Paradise System"), a catheter-based RDN system developed by Defendant Recor Medical, Inc. (Compl. ¶35).
Functionality and Market Context
- The Paradise System is designed to treat hypertension by using ultrasound energy to ablate sympathetic nerves surrounding the renal arteries (Compl. ¶36). The system received FDA approval for this purpose on November 7, 2023 (Compl. ¶37).
- Its core components include a generator and a catheter featuring a cylindrical ultrasound transducer located inside an inflatable balloon at its distal end (Compl. ¶¶54, 74). The image provided as Figure 3 in the complaint depicts the distal end of the Paradise Catheter, showing the transducer positioned within the balloon (Compl. ¶54).
- The system operates by advancing the catheter into a renal artery, inflating the balloon with sterile water, and delivering ultrasound energy (Compl. ¶¶52, 70). The balloon serves both to center the transducer within the artery and to circulate the sterile water as a coolant, which is alleged to protect the arterial wall from thermal injury while the external nerves are ablated (Compl. ¶¶58, 113). The complaint includes an image of the full system, labeled Figure 2, showing the generator, catheter, and associated components (Compl. ¶56).
IV. Analysis of Infringement Allegations
’629 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a catheter sized and shaped for delivery within a blood vessel to a vicinity of neural fibers that contribute to renal function | The Accused Product is a catheter-based system introduced via femoral access and advanced into the main renal artery to ablate sympathetic nerves. | ¶¶51-52 | col. 8:8-12 |
| an ultrasound transducer carried by the catheter, wherein the ultrasound transducer is configured to transmit ultrasound energy waves to target renal neural fibers outside of the blood vessel to thermally induce modulation of target neural fibers | The Paradise Catheter has an ultrasound transducer that delivers ultrasound energy through the renal arterial wall to ablate adjacent sympathetic nerves. | ¶¶55, 57 | col. 12:5-14 |
| while protecting non-target tissue in the blood vessel wall from thermal injury | The system circulates sterile water within its balloon as a coolant during thermal ablation to prevent arterial wall injury. | ¶¶55, 58 | col. 5:1-10 |
| an expandable member carried by a distal region of the catheter, wherein the expandable member is configured to vary between a reduced configuration for delivery and retrieval and an expanded deployed configuration | The Paradise Catheter has an inflatable balloon at its distal end that is automatically inflated for the procedure and deflated for movement or removal. | ¶¶60, 69-71 | col. 9:11-17 |
| wherein the ultrasound transducer is positioned on a shaft of the catheter and within the expandable member | The Accused Product's cylindrical ultrasound transducer is located inside the inflatable balloon at the distal end of the catheter. | ¶¶72, 74 | col. 9:17-20 |
- Identified Points of Contention:
- Scope Questions: A central question for construction may be the meaning of the functional limitation "protecting non-target tissue...from thermal injury." The dispute may focus on whether the active cooling mechanism of the Accused Product (circulating sterile water) falls within the scope of protection described in the patent, which also contemplates using natural blood flow as a heat sink (’629 Patent, col. 5:11-15).
- Technical Questions: The complaint alleges that the Accused Product's cooling system performs the "protecting" function. The factual dispute will likely center on evidence demonstrating how and to what extent the circulating coolant in the Paradise System actually prevents thermal injury to the blood vessel wall during operation.
’085 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a catheter | The Accused Product is a catheter-based system utilizing an intraarterial catheter. | ¶¶98-100 | col. 7:51-52 |
| at least one neuromodulation element carried by a distal portion of the catheter | The Accused Product has an ultrasound transducer, identified as the neuromodulation element, carried by the distal portion of the catheter. | ¶¶102-103 | col. 8:54-56 |
| a generator configured to: generate energy sufficient to ablate renal neural fibers adjacent a renal blood vessel of the patient, and deliver the energy, via the at least one neuromodulation element... | The Paradise System includes a generator that powers the transducer to deliver ultrasound energy, which ablates renal sympathetic nerves. | ¶¶104-107 | col. 8:10-14 |
| an expandable positioning element carried by the distal portion of the catheter | The Accused Product has a distal balloon that serves as the expandable positioning element. | ¶111 | col. 9:11-13 |
| wherein the expandable positioning element is configured to receive a cooling fluid configured to remove heat from within the expandable positioning element | The distal balloon is pressurized with sterile water that circulates within it as a coolant to cool the renal artery wall and prevent injury. | ¶¶111, 113-114 | col. 9:46-52 |
| wherein the distal portion of the catheter, the expandable positioning element, and the at least one neuromodulation element are configured to be positioned in the renal blood vessel... | The Paradise Catheter, including its distal balloon and transducer, is introduced via femoral access and advanced into the main renal artery for the procedure. | ¶¶115, 117 | col. 7:41-47 |
| wherein the expandable positioning element is transformable from a low profile delivery configuration to an expanded configuration | The system's catheter is advanced into the artery, and then its balloon is inflated for the procedure and automatically deflated for removal. | ¶¶118-121 | col. 9:14-17 |
| wherein, in the expanded configuration, the at least one neuromodulation element is spaced radially inward from an outer diameter of the expandable positioning element | The system's transducer is centered within the balloon upon inflation. An included diagram shows the transducer positioned centrally, away from the balloon's outer wall. | ¶¶122-124 | col. 9:17-20 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis may turn on the construction of "remove heat from within the expandable positioning element." A question for the court is whether this language requires the heat to originate inside the element, or if it is met by a configuration where a fluid located inside the element removes heat originating externally (e.g., from the vessel wall).
- Technical Questions: Does the Accused Product's circulation of coolant inside the balloon function primarily to remove heat generated by the transducer itself, or to act as a heat sink for the artery wall being exposed to ultrasound energy? The evidence presented on the thermal dynamics of the Paradise System will be critical to mapping its function onto this claim language.
V. Key Claim Terms for Construction
The Term: "protecting non-target tissue in the blood vessel wall from thermal injury" (’629 Patent, Claim 1)
Context and Importance: This functional language is central to the invention's stated purpose. The scope of "protecting" will be critical, as the Accused Product employs an active cooling mechanism not explicitly detailed in the ’629 patent's embodiments. Practitioners may focus on this term because the mechanism of protection is a key point of technical differentiation.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses protection broadly, including by focusing energy away from non-target tissue or by utilizing "blood flow as a conductive and/or convective heat sink" (’629 Patent, col. 5:11-15). This could support an interpretation where any mechanism that achieves the result of protection, including active cooling, is covered.
- Evidence for a Narrower Interpretation: A party could argue that the means of protection are limited to those described, such as relying on natural blood flow or using pulsed energy delivery (’629 Patent, col. 5:11-30). The absence of an explicit disclosure of a circulated fluid coolant within the catheter could be cited to support a narrower scope that excludes the Accused Product's specific design.
The Term: "configured to remove heat from within the expandable positioning element" (’085 Patent, Claim 1)
Context and Importance: This phrase is highly specific and its interpretation will likely determine infringement of the ’085 patent. The dispute will center on the source and location of the heat being removed. Practitioners may focus on this term because its precise phrasing creates a potential mismatch with the alleged operation of the accused device, which uses the internal fluid to cool an external surface (the artery wall).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's overall objective is to use a cooling fluid to protect the vessel wall while ablating external nerves (’085 Patent, col. 5:4-9). Language describing the cooling system as one that "optionally may be utilized to protect smooth muscle cells or other non-target tissue from undesired thermal effects" could support a reading where the location of the heat source is less important than the overall protective function achieved by the fluid within the element (’085 Patent, col. 5:1-4).
- Evidence for a Narrower Interpretation: The plain language "from within" could be interpreted to mean that the heat being removed must originate inside the expandable element itself (e.g., heat generated by the transducer). The Abstract also uses this precise phrasing, suggesting it is a deliberate and potentially limiting description of the invention's mechanics.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement of both patents based on Defendant’s activities, including creating and distributing technical, marketing, and educational materials that instruct customers and end-users on how to use the Accused Product in an infringing manner (Compl. ¶¶81, 130). Specific examples include instructional videos on Defendant's "Educational Resources" website (Compl. ¶¶82, 131).
- Willful Infringement:
- For the ’629 Patent, willfulness is alleged based on pre-suit knowledge dating back to at least December 8, 2021, from a letter notifying Defendant of a "German Action" involving the patent, as well as knowledge from prior declaratory judgment actions filed by Defendant (Compl. ¶83).
- For the ’085 Patent, willfulness is alleged based on knowledge dating back to at least June 3, 2024, when Defendant filed counterclaims in a related declaratory judgment action (Compl. ¶132).
- For both patents, the complaint alleges that the infringement is egregious and constitutes copying of Medtronic's intellectual property (Compl. ¶¶84, 132).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary issue will be one of definitional scope: can the functional term "protecting non-target tissue" in the ’629 Patent be construed to cover the active, circulated-fluid cooling system of the Accused Product? Similarly, for the ’085 Patent, what is the scope of the phrase "remove heat from within the expandable positioning element"—does it require the heat source to be internal to the element, or can it cover the removal of external heat by a fluid contained inside it?
- A key evidentiary question will be one of technical function: what evidence will demonstrate the precise thermal dynamics of the Accused Product? The case will likely require expert testimony on whether the system's primary cooling function is to dissipate heat from the transducer itself or to actively cool the arterial wall, and how that technical reality maps onto the specific language of the asserted claims.
- Given the alleged history of litigation and pre-suit notice, a central question will be one of intent and objective recklessness: did Defendant act despite an objectively high likelihood that its actions constituted infringement of a valid patent? The answer will depend on the strength of its non-infringement and invalidity defenses and its knowledge of the patents at the time of the accused conduct.