PTAB

IPR2022-00431

Otsuka Medical Devices Co Ltd v. Medtronic Ireland Mfg Unlimited Co

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Ultrasound Apparatus for Renal Neuromodulation
  • Brief Description: The ’629 patent discloses an apparatus for treating conditions such as hypertension through renal denervation. The invention comprises an intravascular catheter equipped with an ultrasound transducer that, when positioned within a renal blood vessel, delivers focused energy to ablate surrounding renal nerves while minimizing thermal injury to the vessel wall.

3. Grounds for Unpatentability

Ground 1: Obviousness over Levin in view of Acker - Claims 1-4 and 8-11

  • Prior Art Relied Upon: Levin (Application # 2003/0216792) and Acker (Patent 6,669,655).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Levin taught the foundational method of treating hypertension via intravascular renal nerve modulation using a catheter, but disclosed using RF electrical energy. Acker taught a technically advanced intravascular catheter that used a focused ultrasound transducer within an expandable balloon to ablate tissue outside a blood vessel, specifically noting its ability to create a ring-like ablation zone remote from the catheter while protecting the vessel wall. The combination of Levin’s therapeutic method with Acker’s superior ablation device allegedly rendered the claims obvious.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Levin’s method with Acker’s device to improve the known therapy. Ultrasound was a known and predictable alternative to RF energy for tissue ablation. Acker's focused ultrasound offered the clear advantage of precise energy delivery to the target nerves while protecting non-target tissue like the artery wall from thermal damage, a known risk with less-focused energy sources.
    • Expectation of Success: A POSA would have a reasonable expectation of success. Acker’s catheter was described as being adaptable for various blood vessels, and catheter-based procedures in the renal artery were well-established. The principles of ultrasound ablation were well understood, presenting no unpredictable results in this new anatomical application.

Ground 2: Anticipation by Acker - Claims 1-3 and 8-9

  • Prior Art Relied Upon: Acker (Patent 6,669,655).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground asserted that Acker alone anticipated the claims, contingent on the claim term "configured to" being construed as "capable of." Petitioner argued that Acker's device, while not explicitly designed for renal denervation, possessed all the necessary structural features to perform the claimed functions. Acker disclosed an ultrasound catheter appropriately sized for intravascular use, carrying a transducer on a shaft within an expandable, acoustically transmissive balloon, and capable of focusing energy to ablate external tissue. Therefore, Acker’s apparatus was inherently capable of performing thermally-induced renal neuromodulation as claimed.

Ground 3: Obviousness over Acker in view of POSA Knowledge - Claims 1-4 and 8-11

  • Prior Art Relied Upon: Acker (Patent 6,669,655) in view of the general knowledge of a POSA.

  • Core Argument for this Ground:

    • Prior Art Mapping: Acker provided a suitable tool: an intravascular ultrasound ablation catheter capable of targeting tissue outside a blood vessel. The extensive body of medical and scientific literature at the time established that renal denervation was a safe and effective treatment for hypertension.
    • Motivation to Combine: The motivation arose from a well-established, unmet clinical need. A POSA, aware of the widespread problem of drug-resistant hypertension and the documented success of renal denervation in treating it, would have been motivated to apply a known and suitable tool like Acker’s catheter to perform this therapy. Using a minimally invasive catheter-based approach was a known strategy to improve upon more invasive surgical denervation procedures.
    • Expectation of Success: Success was reasonably expected based on the proven efficacy of renal denervation and the known capabilities of intravascular ultrasound ablation catheters like Acker’s.

  • Additional Grounds: Petitioner asserted that claim 12 is obvious over the combinations in Ground 1 and Ground 3 with the further addition of Yock (Patent 5,000,185), which taught the simple and advantageous addition of an ultrasound imaging transducer to a therapeutic intravascular catheter.

4. Key Claim Construction Positions

  • Term: "configured to" (recited in claims 1, 3, 4, 8, and 9).
  • Proposed Construction: Petitioner argued the term should be construed to mean "able to" or "capable of." This construction, supported by prosecution history and PTAB precedent, focuses on the structural capabilities of the apparatus rather than a specific design intent. This interpretation was critical to Petitioner's anticipation argument (Ground 2), where Acker’s device was alleged to be capable of performing the claimed method even if not explicitly described for that purpose.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not exercise its discretion to deny institution under 35 U.S.C. §325(d), even though the primary references were cited during prosecution. The argument centered on the assertion that the Examiner overlooked the key teachings. Specifically, Acker taught the very limitations—an ultrasound transducer positioned on a shaft within an expandable member—that were added to overcome prior art rejections and were likely the basis for allowance. Petitioner contended these references were effectively lost in a submission of approximately 1,500 documents and were never substantively analyzed or applied on the record by the Examiner.

6. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-4 and 8-12 of the ’629 patent as unpatentable.