DCT

1:19-cv-00325

Nevro Corp v. Stimwave Tech Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00325, D. Del., 02/14/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s spinal cord stimulation systems infringe five patents related to high-frequency, paresthesia-free electrical therapy for chronic pain.
  • Technical Context: The technology involves implantable medical devices for spinal cord stimulation (SCS), a method of neuromodulation used to treat chronic pain, which represents a significant healthcare market.
  • Key Procedural History: The complaint alleges that in June 2014, Defendant’s CEO communicated to Plaintiff’s Chief Medical Officer that activating high-frequency programming on its systems in the United States would violate Plaintiff’s patents. It also alleges that during the prosecution of a patent application filed by Defendant’s CEO, the patent examiner cited a related Nevro patent as pertinent art.

Case Timeline

Date Event
2009-04-22 Earliest Priority Date for all Patents-in-Suit
2014-06-XX Defendant's CEO allegedly acknowledged Plaintiff's patents would be infringed by HF activation in the U.S.
2014-10-21 U.S. Patent No. 8,868,192 Issues
2014-10-28 U.S. Patent No. 8,874,222 Issues
2015-05-08 Plaintiff's Senza system receives FDA approval
Late 2015 Defendant obtains European CE Mark for Freedom-8A system with 10,000 Hz programming
2016-05-03 U.S. Patent Nos. 9,327,127 and 9,327,126 Issue
2016-05-10 U.S. Patent No. 9,333,358 Issues
2016-06-XX Defendant begins Belgian clinical study using 10,000 Hz parameters
2017-12-XX Defendant's CEO publishes article touting high-frequency therapy
2018-XX-XX Defendant presents "Choose Your Waveform" slide at U.S. medical conference
2019-02-14 Complaint Filed

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

U.S. Patent No. 9,333,358 - “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods”

  • Issued: May 10, 2016

The Invention Explained

  • Problem Addressed: The patent’s background section describes that conventional low-frequency spinal cord stimulation (SCS) systems for pain treatment generate a tingling sensation called paresthesia, which many patients find unpleasant or less beneficial than the underlying pain. This paresthesia can also vary uncomfortably with patient movement. (’192 Patent, col. 1:47-54).
  • The Patented Solution: The invention proposes using high-frequency electrical modulation, in a range of approximately 1.5 kHz to 50 kHz, applied to the patient's spinal cord to reduce pain without creating paresthesia. This approach is intended to provide more effective pain relief with fewer side effects compared to traditional SCS. (’192 Patent, Abstract; col. 2:56-62).
  • Technical Importance: This technology represented a shift from masking pain with paresthesia to inhibiting pain signals at the neural level without generating the sensation, potentially expanding the therapy’s efficacy and patient acceptance. (Compl. ¶14).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶56).
  • Claim 1 requires a system comprising:
    • An implantable signal delivery device for delivering a therapy signal to the spinal cord region.
    • A signal generator programmed to generate a non-paresthesia-producing therapy signal with a frequency between 1.5 kHz and 50 kHz.
    • The signal generator is in electrical communication with the delivery device.
    • A power source configured to power the signal generator.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 8,868,192 - “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods”

  • Issued: October 21, 2014

The Invention Explained

  • Problem Addressed: The technology addresses the same technical problem described for the ’358 Patent: the limitations and undesirable side effects of conventional, paresthesia-based SCS therapy. (’192 Patent, col. 1:47-54).
  • The Patented Solution: The invention is a system for epidural spinal cord stimulation that reduces pain without paresthesia by using a programmer with a therapy program that directs a spinal cord modulator to deliver a therapy signal comprising sequential biphasic pulses with specific pulse widths (25 to 166 microseconds). This specific waveform is designed to achieve the therapeutic effect without the paresthesia side effect. (’192 Patent, col. 21:52-65; Claim 1).
  • Technical Importance: By defining specific signal parameters like pulse width in combination with the paresthesia-free outcome, the invention sought to provide a more precisely defined and reproducible method for high-frequency SCS therapy. (Compl. ¶13-14).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1. (Compl. ¶72).
  • Claim 1 requires a system comprising:
    • A programmer with a therapy program that directs delivery of a therapy signal.
    • The signal is delivered by a spinal cord modulator to a signal delivery device.
    • The therapy signal reduces pain without generating paresthesia.
    • The signal includes sequential biphasic pulses with pulse widths from 25 to 166 microseconds.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 9,327,127 - “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods”

  • Issued: May 3, 2016
  • Technology Synopsis: This patent claims a method for treating a patient by delivering a high-frequency (1.5 kHz to 50 kHz) electrical signal to the patient's spinal cord that does not create paresthesia. It focuses on the method of treatment itself rather than the system components. (Compl. ¶86).
  • Asserted Claims: At least independent claim 1. (Compl. ¶86, 88).
  • Accused Features: The complaint alleges that Defendant and its agents infringe by programming the accused SCS systems to deliver paresthesia-free therapy at frequencies within the claimed range, particularly at 10 kHz. (Compl. ¶88).

U.S. Patent No. 8,874,222 - “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods”

  • Issued: October 28, 2014
  • Technology Synopsis: This patent claims a method for configuring a signal generator to deliver a therapy signal to the spinal cord. The method involves programming the generator to produce a signal between 5 kHz and 15 kHz at an amplitude that provides pain relief without paresthesia. (Compl. ¶99).
  • Asserted Claims: At least independent claim 1. (Compl. ¶99, 101).
  • Accused Features: The complaint alleges that Defendant and its agents infringe by configuring the accused SCS systems to provide therapy signals within the claimed frequency and amplitude ranges to achieve pain relief without paresthesia. (Compl. ¶101).

U.S. Patent No. 9,327,126 - “Selective high frequency spinal cord modulation for inhibiting pain with reduced side effects, and associated systems and methods”

  • Issued: May 3, 2016
  • Technology Synopsis: This patent claims a method for programming an SCS system to alleviate pain without paresthesia by delivering an electrical signal between 3 kHz and 20 kHz at a specific amplitude range (1 mA to 4 mA) to a percutaneous lead positioned near the dorsal root. (Compl. ¶112).
  • Asserted Claims: At least independent claim 31. (Compl. ¶112, 114).
  • Accused Features: The complaint alleges that Defendant and its agents infringe by programming the accused SCS systems to deliver therapy at the claimed frequency (specifically 10 kHz) and amplitude to achieve non-paresthesia pain relief. (Compl. ¶114).

III. The Accused Instrumentality

Product Identification

  • The accused products are Stimwave’s Freedom Spinal Cord Stimulation (SCS) systems, including at least the Freedom-8A SCS system. (Compl. ¶7, 22).

Functionality and Market Context

  • The accused system includes an implantable device with electrodes (a "Freedom Stimulator") and an external "Wearable Antenna Assembly" (WAA) that contains a battery and communicates with the implant via radiofrequency signals. (Compl. ¶22, 24). A clinical representative uses an external programming tablet (a "WaveCrest programmer") to set stimulation parameters, including frequency, pulse width, and amplitude. (Compl. ¶25).
  • The complaint provides a technical specifications table from Defendant's materials showing the system is capable of delivering a biphasic waveform at a "Pulse Rate" of 5 - 10,000 Hz. (Compl. p. 8). A marketing slide presented by Defendant also shows a "SURF (High Density & High Frequency)" mode with a frequency range of 1,000 - 10,000 Hz. (Compl. ¶35, p. 11).
  • Plaintiff alleges Defendant markets these systems for use in high-frequency, paresthesia-free therapy in Europe and Australia and is seeking imminent FDA approval for the same use in the United States. (Compl. ¶27).

IV. Analysis of Infringement Allegations

9,333,358 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
an implantable signal delivery device configured for delivering a therapy signal to one or more locations in the patient's spinal cord region; Defendant's system includes an implantable stimulator with electrodes placed in the patient's epidural space to deliver a signal to the spinal cord region. ¶22-23, 55 col. 3:32-40
a signal generator programmed to generate a non-paresthesia-producing therapy signal, wherein at least a portion of the therapy signal has a frequency in a frequency range between 1.5 kHz and 50 kHz... Defendant's system includes a signal generator that is allegedly programmed, using an external tablet, to generate signals at 10,000 Hz (10 kHz) to provide pain relief without paresthesia. ¶25, 26, 55 col. 3:52-61
...at an amplitude that provides pain relief without generating paresthesia; Defendant's website allegedly states the therapy "can feel like a tingling sensation or no sensation at all," which Plaintiff equates to paresthesia-free therapy. ¶36, 55 col. 9:8-16
and wherein the signal generator is in electrical communication with the implantable signal delivery device; Defendant's implantable stimulator and signal generator allegedly communicate electrically with each other. ¶55 col. 3:35-37
and a power source, wherein the power source is configured to power the signal generator. Defendant's external Wearable Antenna Assembly (WAA) contains a rechargeable battery that powers the system. ¶24, 55 col. 4:26-31
  • Identified Points of Contention:
    • Scope Questions: A central dispute may arise over the term "signal generator". The complaint alleges Defendant's system meets this limitation, but Defendant may argue that its architecture, which separates the power source and some control electronics into an external wearable unit, differs from the "signal generator" contemplated by the patent, which may be construed to require a fully implantable pulse generator (IPG). The complaint appears to preemptively address this by noting that Claim 1 "does not require an implantable IPG" (Compl. ¶60, 65).
    • Technical Questions: The infringement allegation relies on the system being "programmed" for high-frequency, paresthesia-free operation. The case may turn on evidence of how often and for what purposes Defendant's systems are actually programmed and used in this mode, particularly in the United States pending FDA approval.

8,868,192 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a programmer having a therapy program that, when executed, directs delivery of a therapy signal by a spinal cord modulator to a signal delivery device... Defendant's WaveCrest programmer is a tablet used by a clinical representative to set therapy programs that direct the system to deliver signals to the implantable stimulator. ¶25, 71 col. 4:45-55
wherein the therapy signal at least partially reduces pain without generating paresthesia, Defendant's systems are allegedly programmed and used to reduce pain without causing paresthesia. ¶26, 71 col. 26:1-3
and wherein the therapy signal includes a plurality of sequential biphasic pulses, Defendant's technical specifications state its systems use a "biphasic waveform." ¶26, 71, p. 8 col. 26:4-6
with the pulses having pulse widths in a pulse width range from 25 microseconds to 166 microseconds. The complaint alleges Defendant's systems are programmed with pulse widths within this range. Defendant's own specifications list a broader range of 10 - 1,000 µs, which overlaps the claimed range. ¶71, p. 8 col. 26:7-8
  • Identified Points of Contention:
    • Scope Questions: The definition of "programmer" and "spinal cord modulator" may be disputed. Defendant could argue that its system, with its combination of an external tablet, a wearable antenna/power unit, and an implanted stimulator, does not map onto the claim's architecture in a one-to-one manner.
    • Technical Questions: What evidence does the complaint provide that the pulse widths actually used in the accused high-frequency mode fall within the specific range of 25-166 microseconds? The complaint's own visual evidence shows a broader available range (10-1,000 µs), raising the question of which specific parameters are used in the allegedly infringing configuration. (Compl. p. 8).

V. Key Claim Terms for Construction

For the ’358 Patent:

  • The Term: "signal generator"
  • Context and Importance: This term is critical because Defendant’s primary non-infringement defense, as anticipated by the complaint, is that its system lacks a fully Implantable Pulse Generator (IPG). (Compl. ¶40, 60). The construction of "signal generator" will determine if a system where the power source and some control logic are external to the body can meet this limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claims do not explicitly require the signal generator to be implantable, only that it be in "electrical communication" with an "implantable signal delivery device." The specification describes the "pulse generator 101" which "may be implanted subcutaneously" but also discusses embodiments where an "external programmer 105" can be coupled to the signal delivery element to provide signals during a trial period. (’192 Patent, col. 3:30-32, col. 4:45-52). This may support an argument that the signal generation function is not strictly limited to a fully implanted component.
    • Evidence for a Narrower Interpretation: The primary embodiment described and illustrated in the patent shows a single "implantable pulse generator 101" that contains the processor, memory, and an internal power source (rechargeable or non-rechargeable). (’192 Patent, Fig. 1A; col. 4:38-41). This could support an argument that a person of ordinary skill in the art would understand the "signal generator" to be the single, integrated implantable unit that was conventional at the time.

For the ’192 Patent:

  • The Term: "programmer having a therapy program"
  • Context and Importance: The infringement theory relies on Defendant's "WaveCrest programmer" tablet meeting this limitation. (Compl. ¶71). The construction will determine if a general-purpose tablet, running specific software and used by a clinician, constitutes the claimed "programmer."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term "programmer" is not explicitly defined. The specification describes an "external programmer 105 (e.g., a trial modulator)" used by a practitioner to "vary the modulation parameters" and select "optimal or particularly efficacious parameters." (’192 Patent, col. 4:45-52). This description aligns with the alleged function of Defendant's WaveCrest tablet.
    • Evidence for a Narrower Interpretation: The specification also discusses a "wireless physician's programmer" and a "wireless patient programmer," suggesting different types of programmers for different functions. (’192 Patent, col. 5:27-31). Defendant could argue that the specific "programmer" of claim 1, which "directs delivery of a therapy signal by a spinal cord modulator," refers to a more integrated component of the system rather than a standalone clinical tablet used for initial setup.

VI. Other Allegations

  • Indirect Infringement: Plaintiff alleges infringement under 35 U.S.C. § 271(f) by asserting that Defendant supplies components of its SCS systems from the United States to Europe and Australia, intending them to be combined in a manner that would infringe if the combination occurred in the U.S. (Compl. ¶56-57, 72-73). The complaint also alleges inducement based on Defendant's promotional materials, manuals, and training by sales and clinical representatives, which allegedly encourage and instruct others on how to use the systems in an infringing manner. (Compl. ¶56, 89, 102).
  • Willful Infringement: The complaint alleges willfulness based on both pre-suit and post-suit knowledge. Pre-suit knowledge is alleged based on a June 2014 communication from Defendant's CEO acknowledging Plaintiff's patents, as well as awareness of Plaintiff's patent portfolio through patent markings, market inquiries, and the prosecution history of an application filed by Defendant's CEO. (Compl. ¶38-39, 60, 76).

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

This case will likely present several central questions for the court's determination:

  • A core issue will be one of architectural scope: Can the claims, which recite components like a "signal generator" and "programmer," be construed to read on Defendant's distributed architecture, where the power source and primary programming interface are located in external, non-implanted devices? Or is a fully integrated, implantable pulse generator (IPG) a required element of the claimed invention?
  • A second key question will be one of territorial infringement: What evidence demonstrates that Defendant supplies a substantial portion of the components for its SCS systems from the United States with the specific intent that they be combined abroad to create an infringing system under 35 U.S.C. § 271(f)?
  • Finally, a critical evidentiary question will be one of actual use: What discovery will show that Defendant’s systems are not merely capable of operating within the claimed parameters (e.g., frequency, pulse width) but are in fact programmed, marketed, and used in a manner that practices the claimed methods of paresthesia-free pain relief, particularly within the United States?