DCT

2:25-cv-01739

Biotronik Inc v. Niazi Patent Holdings LLC

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Key Events
Amended Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Biotronik, Inc. v. Niazi Patent Holdings, LLC, 2:25-cv-01739, E.D. Wis., 12/22/2025
  • Venue Allegations: Venue is alleged as proper because the Defendant, Niazi Patent Holdings, LLC, is a Wisconsin company that resides in the Eastern District of Wisconsin.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its cardiac rhythm management devices do not infringe U.S. Patent No. RE50,170 and/or that the patent’s claims are invalid.
  • Technical Context: The technology involves cardiac resynchronization therapy devices, which use electrical pulses to treat heart failure, specifically focusing on a method of intentionally inducing "anodal capture" to stimulate multiple heart regions simultaneously.
  • Key Procedural History: The complaint alleges that the patent-in-suit, a reissue of an earlier patent, is not entitled to its claimed 2009 priority date due to a break in the patent application chain. Plaintiff asserts that this earlier priority date was used during reissue prosecution to overcome prior art. The complaint leverages declarations the inventor filed during that reissue proceeding—attesting to inventing and using the technology before 2010—as admissions that now constitute an invalidating "public use" or "on sale" bar against the patent's alleged true 2011 priority date. The suit follows pre-suit licensing discussions in which Defendant provided Plaintiff with claim charts alleging infringement.

Case Timeline

Date Event
2009-04-02 Inventor’s first alleged procedure demonstrating the invention
2009-06-30 Filing date of the Williamson patent, cited as prior art during reissue
2009-10-06 Earliest patent priority date (Provisional App. 61/272,563 filed)
2010-10-06 Non-Provisional App. 12/899,244 filed
2010-12-23 Non-Provisional App. 12/899,244 abandoned, allegedly breaking the priority chain
2011-03-22 Continuation-in-Part App. 13/053,965 filed (led to original patent)
2014-09-16 U.S. Patent No. 8,838,237 (original patent) issued
2021-07-02 Reissue application for the patent-in-suit filed
2024-10-15 U.S. Patent No. RE50,170 (reissue patent-in-suit) issued
2025-12-22 Complaint for Declaratory Judgment filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Reissue Patent No. RE50,170 - "Summation Anodal Pacing to Complement Multisite Stimulation"

The Invention Explained

  • Problem Addressed: In conventional cardiac pacing, an electrical stimulus is delivered from a negative electrode (cathode) to trigger heart muscle contraction. The positive electrode (anode) serves only to complete the circuit, and stimulation at the anode ("anodal capture") has historically been considered an undesirable side effect to be avoided. (’170 Patent, col. 1:31-41, col. 2:5-7).
  • The Patented Solution: The patent proposes intentionally harnessing anodal capture for therapeutic benefit. The invention uses an anode with a sufficiently small surface area, which creates a "virtual cathode" remote from the anode itself when current returns to it from the primary cathode. (’170 Patent, Abstract; col. 2:11-17). This technique allows a single cathodal pulse to stimulate two distinct areas of the heart muscle—one at the cathode and one at the virtual cathode created by the anode—thereby achieving multi-site stimulation more efficiently. (’170 Patent, col. 2:18-29).
  • Technical Importance: This approach suggests a method to enhance cardiac resynchronization therapy by achieving a more widespread and coordinated contraction of the heart's ventricles, potentially improving pumping efficiency in patients with heart failure. (Compl. ¶¶ 18, 22).

Key Claims at a Glance

  • The complaint identifies independent claims 22 and 29 as representative of the dispute (Compl. ¶¶ 86, 92).
  • Independent Claim 22 (Device) Essential Elements:
    • A device with a current source and three leads for the right atrium, right ventricle, and left ventricle.
    • The left ventricle lead must have at least two electrodes.
    • At least one electrode serves as a cathode and another as an anode.
    • The anode must have a "surface area... sized sufficiently small to cause anodal capture."
    • The device delivers a cathodal stimulation that results in "anodal capture of a portion of the heart via the return electrode."
    • The return electrode (anode) must itself be a "pacing electrode."
    • The cathodal stimulation and the resulting anodal capture must be "simultaneous" and the anodal capture must occur "solely as a consequence of the cathodal stimulation of another electrode."
  • The complaint notes that Defendant has asserted infringement of claims 1-3, 5, 7, 11-13, and 22-30 (Compl. ¶¶ 76, 80).

III. The Accused Instrumentality

Product Identification

  • Plaintiff’s pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, including the Amvia Edge, Acticor, Edora, Enticos, Evity, Rivacor, Ilivia Neo, and Intica Neo models (the "Accused Products") (Compl. ¶¶ 4, 75, 79 fn. 2).

Functionality and Market Context

  • The Accused Products are cardiac rhythm management systems designed to restore normal heart rhythm by delivering electrical impulses to the heart muscle via implanted leads (Compl. ¶17). The complaint asserts these devices are highly configurable by physicians to meet individual patient needs (Compl. ¶20). Plaintiff contends that the devices can be operated in numerous non-infringing ways, such as with left ventricle leads that have only one electrode, or in configurations where no electrode on the left ventricle lead serves as an anode (Compl. ¶87). A central argument in the complaint is that anodal capture is a patient-specific physiological response, not an inherent property of the device itself (Compl. ¶88).

IV. Analysis of Infringement Allegations

The complaint references claim charts provided by Defendant pre-suit, but the charts themselves are not included in the provided court filing. The infringement theory is therefore summarized based on Plaintiff’s arguments for non-infringement.

RE50,170 Infringement Allegations

The core of the infringement dispute, as framed by the complaint, appears to center on whether the Accused Products meet the functional and structural requirements of claim 22. Plaintiff argues for non-infringement on at least two primary grounds.

First, Plaintiff contends that its devices do not meet the structural requirements of claim 22 "when made, used, sold, offered for sale, or imported" (Compl. ¶87). For example, claim 22 requires the left ventricle lead to have at least two electrodes, with one serving as a cathode and one as an anode. Plaintiff alleges its devices are compatible with a variety of leads, including those with only a single electrode, and can be configured such that no electrode on a multi-electrode left ventricle lead serves as an anode (Compl. ¶87). This suggests Defendant’s infringement theory relies on a specific, post-implant configuration chosen by a physician rather than an inherent feature of the device as sold.

Second, Plaintiff argues that its devices do not meet the functional limitations of the claims, such as the requirement for "anodal capture that occurs solely as a consequence of the cathodal stimulation" (Compl. ¶88). Plaintiff characterizes anodal capture as a physiological event dependent on patient-specific factors (e.g., heart tissue health) and physician choices (e.g., lead placement, device settings), rather than a guaranteed outcome of the device's operation (Compl. ¶88). This frames the dispute around whether the device itself directly causes the claimed result or merely creates a condition where the result might occur in a patient's body. The complaint uses a timeline graphic to illustrate the key dates related to its invalidity arguments. This visual, titled "Figure 2: Critical Dates Timeline," chronologically arranges events from the inventor's alleged first procedure in April 2009 to the filing of the application that Plaintiff asserts is the true priority date in March 2011 (Compl. p. 11, Fig. 2).

V. Key Claim Terms for Construction

  • The Term: "a surface area of at least one of the electrodes is sized sufficiently small to cause anodal capture"

    • Context and Importance: This term defines a physical dimension (surface area) by the function it performs. Its construction is critical because it defines the boundary of the claim. Plaintiff directly challenges this term as indefinite under 35 U.S.C. § 112, arguing it fails to inform a person of ordinary skill in the art of the claim's scope with reasonable certainty (Compl. ¶99).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent specification does not appear to provide specific numerical dimensions for the electrode surface area, instead describing the outcome functionally: "When the anodal surface area is sufficiently small, this creates an area of hyper-polarization of the myocardial cell membrane" (’170 Patent, col. 2:13-15). This may support a construction where any electrode capable of causing anodal capture under some clinical conditions meets the limitation.
      • Evidence for a Narrower Interpretation: The patent’s stated purpose is to intentionally use anodal capture, suggesting the sizing is a deliberate design choice, not an accident. The abstract links the small surface area to the specific physical mechanism of creating hyper-polarization, which may support a narrower construction requiring a size that reliably produces this effect for therapeutic pacing.

  • The Term: "the return electrode is a pacing electrode"

    • Context and Importance: This limitation requires the anode (the "return electrode") to also qualify as a "pacing electrode." The definition will determine whether an electrode that only passively completes a circuit and induces a secondary capture effect can satisfy the claim, or if it must be an electrode actively used for primary cathodal pacing.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party could argue that any electrode constructed of materials and with a structure suitable for delivering a pacing stimulus is a "pacing electrode," regardless of its function in a particular claimed step.
      • Evidence for a Narrower Interpretation: The specification distinguishes between cathodes that deliver the primary stimulus and anodes that serve as the return. A party could argue that "pacing electrode" in its conventional sense refers to an electrode delivering a cathodal stimulus to initiate depolarization, and that the claim requires the anode to also serve this primary pacing function in some capacity.

VI. Other Allegations

  • Indirect Infringement: Plaintiff preemptively denies indirect infringement. It alleges it does not induce infringement because it "does not instruct, encourage, or otherwise take action to cause physicians" to operate the Accused Products in an infringing manner (Compl. ¶91). It denies contributory infringement by asserting the products have substantial non-infringing uses, such as being configured in ways that do not cause anodal capture or used with leads that cannot practice the invention (Compl. ¶90).
  • Willful Infringement: Willfulness is not alleged in the complaint, as Plaintiff is the party seeking declaratory relief. However, the complaint details Defendant’s pre-suit notice, including the provision of infringement claim charts (Compl. ¶¶ 76, 80), which could form the basis for a future counterclaim of willful infringement by the Defendant.

VII. Analyst’s Conclusion: Key Questions for the Case

The complaint frames the dispute around three central questions for the court:

  1. A core issue will be one of patent priority and validity: Did the 2010 abandonment of an intervening application break the patent’s priority chain, as alleged in the complaint? If so, the inventor's own sworn declarations of pre-2010 reduction to practice, filed to overcome prior art during reissue, may become invalidating prior public uses under 35 U.S.C. § 102(b) against the patent's later, true priority date. The complaint's "Figure 1: Priority Chain for the '170 Patent" visual directly illustrates this alleged break in prosecution history (Compl. p. 8, Fig. 1).
  2. A key infringement question will be one of divided responsibility and control: Can a device manufacturer be liable for direct infringement when its product is only capable of performing the claimed method after being implanted and specifically configured by an independent physician, particularly where the claimed outcome ("anodal capture") is alleged to be a patient-dependent physiological phenomenon rather than a direct and certain function of the device?
  3. A dispositive legal question may be one of claim definiteness: Does the functional language "sized sufficiently small to cause anodal capture" provide an objective and reasonably certain boundary for the claim scope, or is it fatally indefinite under 35 U.S.C. § 112 for failing to adequately instruct those skilled in the art?