DCT

1:16-cv-01163

Boston Scientific Corp v. Nevro Corp

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-01163, D. Del., 12/09/2016
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is a resident of the district, maintains systematic and continuous contacts, regularly transacts business, and derives substantial revenue from sales within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Senza® Spinal Cord Stimulation System infringes ten patents related to implantable neurostimulation technology, including systems for recharging, power management, and electrode array manufacturing.
  • Technical Context: The technology concerns spinal cord stimulation (SCS) systems, which are implantable medical devices used to manage chronic pain by delivering electrical pulses to the spinal cord.
  • Key Procedural History: No significant procedural history, such as prior litigation between the parties or post-grant proceedings concerning the asserted patents, is mentioned in the complaint.

Case Timeline

Date Event
1999-07-27 U.S. Patent No. 6,895,280 Priority Date
2002-06-28 U.S. Patent Nos. 7,428,438; 7,437,193; 7,587,241; 8,644,933 Priority Date
2005-01-11 U.S. Patent Nos. 7,891,085; 8,019,439; 8,646,172; 8,650,747 Priority Date
2005-05-17 U.S. Patent No. 6,895,280 Issued
2008-09-23 U.S. Patent No. 7,428,438 Issued
2008-10-14 U.S. Patent No. 7,437,193 Issued
2009-09-08 U.S. Patent No. 7,587,241 Issued
2009-05-26 U.S. Patent No. 9,370,664 Priority Date
2011-02-22 U.S. Patent No. 7,891,085 Issued
2011-09-13 U.S. Patent No. 8,019,439 Issued
2014-02-04 U.S. Patent No. 8,644,933 Issued
2014-02-11 U.S. Patent No. 8,646,172 Issued
2014-02-18 U.S. Patent No. 8,650,747 Issued
2016-06-21 U.S. Patent No. 9,370,664 Issued
2016-12-09 Complaint Filing Date

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

U.S. Patent No. 6,895,280 - "Rechargeable Spinal Cord Stimulator System"

  • Issued: May 17, 2005

The Invention Explained

  • Problem Addressed: The patent describes commercially available spinal cord stimulation (SCS) systems as suffering from shortcomings such as limited battery life, the need for patients to wear external power sources, limited programming features, and large physical size (Compl. Ex. A, ’280 Patent, col. 2:15-33).
  • The Patented Solution: The invention is an SCS system featuring an implantable pulse generator (IPG) with an internal, replenishable power source, such as a rechargeable battery. This allows the patient to operate the device without being tethered to an external power source and enables recharging through non-invasive, transcutaneous power transmission (Compl. Ex. A, ’280 Patent, Abstract; col. 3:29-41). The system also includes multiple, independently programmable stimulation channels to create unique stimulation fields and bi-directional telemetry to report the device's status, including battery charge level (Compl. Ex. A, ’280 Patent, Abstract).
  • Technical Importance: The technology aimed to provide a smaller, more reliable, and longer-lasting implantable SCS system that offered greater patient freedom and more versatile programming options than existing devices (Compl. Ex. A, ’280 Patent, col. 2:33-42).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶12).
  • Essential elements of Claim 1 (a system claim for an implantable pulse generator) include:
    • An implantable pulse generator (IPG) having a housing containing processing circuitry.
    • An implantable electrode array detachably connected to the IPG.
    • A multiplicity of m stimulation channels provided by the IPG, where each channel is independently programmable with different stimulation parameters.
    • Means for non-invasively charging the replenishable power source.
    • The processing circuitry includes a control logic circuit, a timer logic circuit, a microcontroller circuit, and a memory circuit.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,428,438 - "Systems And Methods For Providing Power To A Battery In An Implantable Stimulator"

  • Issued: September 23, 2008

The Invention Explained

  • Problem Addressed: The patent addresses the technical challenge of recharging an implantable medical device's battery when it has been completely discharged to a "zero volt state." In such a state, the device's own control circuitry, which is needed to manage the recharging process, may lack the power to operate (Compl. Ex. B, ’438 Patent, col. 3:37-44).
  • The Patented Solution: The invention provides a system with a "zero volt recovery (ZVR) circuit." An external device emits a first magnetic field (a "boost field") at a frequency the implant's coil can receive even when unpowered. This boost field provides initial power to the ZVR circuit, which in turn powers the necessary components to "tune" the implant's receiving coil. Once tuned, the coil can efficiently receive a second, primary magnetic field from the external device to perform the main battery recharge (Compl. Ex. B, ’438 Patent, Abstract; col. 4:6-16).
  • Technical Importance: This technology allows for the recovery of an implantable device even after a complete battery discharge, potentially preventing the need for surgical replacement of a device that has simply run out of power.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶22).
  • Essential elements of Claim 1 (a system claim) include:
    • A first coil configured to emit a first magnetic field.
    • A second coil in the stimulator configured to receive the first magnetic field.
    • A zero volt recovery (ZVR) circuit in the stimulator configured to use the first magnetic field to cause the second coil to be tuned to a frequency of a second magnetic field.
    • The second magnetic field is used to provide power to the battery.
  • The complaint does not explicitly reserve the right to assert dependent claims.

U.S. Patent No. 7,437,193 - "Microstimulator Employing Improved Recharging Reporting And Telemetry Techniques"

  • Technology Synopsis: The patent relates to techniques for an implantable microstimulator to automatically control applied stimulation pulses to match programmed parameters and to report its status, such as the charge level of its power source, to an external device via a bidirectional telemetry link (Compl. Ex. C, ’193 Patent, Abstract).
  • Asserted Claims: At least claim 1 (Compl. ¶32).
  • Accused Features: The Nevro Senza System (Compl. ¶32).

U.S. Patent No. 7,587,241 - "Method For Controlling Telemetry In An Implantable Medical Device Based On Power Source Capacity"

  • Technology Synopsis: The patent describes a method for managing power consumption in an implantable medical device. Based on the power source's voltage, the device selectively enables or disables different types of telemetry (e.g., a power-intensive telemetry vs. a low-power one) and the delivery of stimulation to conserve energy (Compl. Ex. D, ’241 Patent, Abstract).
  • Asserted Claims: At least claim 1 (Compl. ¶42).
  • Accused Features: The Nevro Senza System (Compl. ¶42).

U.S. Patent No. 7,891,085 - "Electrode Array Assembly And Method Of Making Same"

  • Technology Synopsis: The patent describes a method for manufacturing a multi-contact medical lead. The method involves placing spacers between conductive contacts and using monofilament material in void spaces, then heating the assembly to cause thermal flow or melting, which fuses the components together (Compl. Ex. E, ’085 Patent, Abstract).
  • Asserted Claims: At least claim 1 (Compl. ¶50).
  • Accused Features: The leads of the Nevro Senza System (Compl. ¶50, ¶52).

U.S. Patent No. 8,019,439 - "Lead Assembly And Method Of Making Same"

  • Technology Synopsis: This patent is related to the '085 patent and further describes lead assemblies and manufacturing methods. It discloses using a preformed spacer or epoxy to separate terminal contacts at the proximal end of the lead to achieve desired stiffness and flexibility (Compl. Ex. F, ’439 Patent, Abstract).
  • Asserted Claims: At least claims 1, 11, and 26 (Compl. ¶58).
  • Accused Features: The leads of the Nevro Senza System (Compl. ¶58, ¶63).

U.S. Patent No. 8,644,933 - "Techniques For Controlling Charging Of Batteries In An External Charger And An Implantable Medical Device"

  • Technology Synopsis: The patent discloses algorithms for an external charger to manage heat generation when charging both its own external battery and an implanted device's battery. The algorithms control whether the batteries are charged sequentially, simultaneously, or at reduced power levels to prevent overheating (Compl. Ex. G, ’933 Patent, Abstract).
  • Asserted Claims: At least claim 1 (Compl. ¶69).
  • Accused Features: The Nevro Senza System (Compl. ¶69).

U.S. Patent No. 8,646,172 - "Electrode Array Assembly And Method Of Making Same"

  • Technology Synopsis: This patent is related to the '085 and '439 patents, describing further methods for manufacturing a stimulation lead. The method involves placing non-conductive material into conductor lumens and heating it to cause thermal reflow or melting (Compl. Ex. H, ’172 Patent, Abstract).
  • Asserted Claims: At least claims 1 and 6 (Compl. ¶79).
  • Accused Features: The leads of the Nevro Senza System (Compl. ¶79, ¶81).

U.S. Patent No. 8,650,747 - "Electrode Array Assembly And Method Of Making Same"

  • Technology Synopsis: This patent is also related to the family of manufacturing patents ('085, '439, '172). It discloses a lead assembly for making a lead that includes a solid, non-conductive material disposed radially underneath the conductive contacts within portions of conductor lumens not occupied by conductor wires (Compl. Ex. I, ’747 Patent, Abstract).
  • Asserted Claims: At least claims 1 and 11 (Compl. ¶87).
  • Accused Features: The leads of the Nevro Senza System (Compl. ¶87, ¶92).

U.S. Patent No. 9,370,664 - "Signaling Error Conditions In An Implantable Medical Device System Using Simple Charging Coil Telemetry"

  • Technology Synopsis: The patent describes a method for an implantable device to signal error conditions using its charging coil, particularly for fundamental errors that may prevent communication via traditional telemetry. The error is encoded in the modulation of the charging coil's impedance, which can be detected by an external charger (Compl. Ex. J, ’664 Patent, Abstract).
  • Asserted Claims: At least claim 1 (Compl. ¶98).
  • Accused Features: The Nevro Senza System (Compl. ¶98).

III. The Accused Instrumentality

Product Identification

  • The complaint identifies the accused instrumentality as Nevro's Senza® Spinal Cord Stimulation System (the "Senza System") (Compl. ¶1). For certain patents related to manufacturing methods, the complaint specifies the "leads" of the Senza System (Compl. ¶50, ¶58, ¶79, ¶87).

Functionality and Market Context

  • The complaint alleges the Senza System is a spinal cord stimulation system used for pain management (Compl. ¶1). No probative visual evidence provided in complaint. The complaint does not provide further technical details regarding the specific architecture, components, or operational features of the Senza System or its leads. The allegations are limited to identifying the system and asserting that its manufacture, use, and sale infringe the asserted patents (Compl. ¶12, ¶22, et seq.).

IV. Analysis of Infringement Allegations

The complaint does not provide sufficient detail for a meaningful element-by-element analysis of the infringement allegations. The pleading asserts infringement in a conclusory manner, stating that Nevro infringes by "making, using, offering to sell, selling, and/or importing...the Senza System" (Compl. ¶12, ¶22, et seq.). No specific product features are mapped to specific claim limitations.

  • Identified Points of Contention:
    • Factual Questions: The primary point of contention will be factual. Discovery will be required to determine the actual design and operation of the Senza System. Key questions will include:
      • Does the Senza System's IPG utilize a "multiplicity of independent bidirectional output current sources" as required by claim 1 of the ’280 Patent, or does it employ an alternative architecture?
      • Does the Senza System's power management circuitry include a "zero volt recovery (ZVR) circuit" that operates by using a first magnetic field to tune a coil to receive a second, as claimed in the ’438 Patent?
      • Are the leads of the Senza System manufactured using methods that include placing and thermally fusing spacers and monofilaments as claimed in the manufacturing patents (e.g., the ’085 Patent)?
      • Does the Senza System employ different telemetry modes based on battery capacity as claimed in the ’241 Patent, or signal fundamental errors via its charging coil as claimed in the ’664 Patent?

V. Key Claim Terms for Construction

For U.S. Patent No. 6,895,280

  • The Term: "independent bidirectional output current sources" (from claim 1).
  • Context and Importance: This term defines the core architecture of the pulse generator's stimulation circuitry. The definition of "independent" will be critical. Practitioners may focus on this term because the dispute may turn on whether Nevro's system uses a different, non-infringing architecture, such as a single current source that is multiplexed to different electrodes, which might not be considered "independent."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification states that the system provides "multiple, independently programmable, stimulation channels" which "can provide concurrent, but unique stimulation fields" (Compl. Ex. A, ’280 Patent, Abstract). This functional language could support a construction that covers any architecture achieving independent channel programmability.
    • Evidence for a Narrower Interpretation: Figure 4C of the patent depicts a specific embodiment with distinct "CURRENT SOURCE" blocks for each of the "ODD" and "EVEN" electrodes, tied to separate latches and sequencers (Compl. Ex. A, ’280 Patent, Fig. 4C-1, Fig. 4C-2). A defendant could argue this structural disclosure limits the scope of "independent" to physically separate and individually controlled hardware sources.

For U.S. Patent No. 7,428,438

  • The Term: "zero volt recovery (ZVR) circuit" (from claim 1).
  • Context and Importance: This term describes the central novel feature of the invention. The case will likely hinge on whether the circuitry within the accused Senza System that handles a fully depleted battery meets the structural and functional requirements of this term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The abstract describes the ZVR circuit functionally as being "configured to use the first magnetic field to cause the coil in the stimulator to be tuned to a frequency of a second magnetic field" (Compl. Ex. B, ’438 Patent, Abstract). This could support a broad functional definition covering any circuit that performs this two-stage recovery process.
    • Evidence for a Narrower Interpretation: The specification discloses a specific implementation of the ZVR circuit based on an "asymmetric static random access memory (SRAM) cell" (Compl. Ex. B, ’438 Patent, col. 8:23-27, Fig. 11). A defendant may argue that the term should be construed as being limited to this disclosed embodiment or its structural equivalents, especially if this feature was highlighted to overcome prior art during prosecution.

VI. Other Allegations

  • Indirect Infringement: For each asserted patent, the complaint alleges active inducement under 35 U.S.C. § 271(b) based on Nevro allegedly instructing others, through marketing, user instructions, and promotion, to use the Senza System in an infringing manner (e.g., Compl. ¶13, ¶23). It also alleges contributory infringement under § 271(c), asserting that the Senza System and its components are a material part of the patented inventions, are not staple articles of commerce, and are sold by Nevro knowing them to be especially adapted for infringement (e.g., Compl. ¶14, ¶24).
  • Willful Infringement: For each asserted patent, the complaint alleges that Nevro had "actual and constructive knowledge" of the patent prior to the filing of the complaint and that its infringement is "reckless, knowing, deliberate, and willful" (e.g., Compl. ¶17, ¶27). The complaint does not specify the factual basis for this alleged pre-suit knowledge.

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

  1. A central issue will be one of factual proof: given the complaint's lack of technical detail, the case will depend on evidence developed during discovery to establish the actual architecture and functionality of the accused Senza System. The dispute will turn on whether the internal circuitry, power management systems, and manufacturing processes of the Senza System and its leads map onto the specific configurations required by the asserted claims.

  2. A key legal issue will be one of claim scope: can claim terms rooted in specific disclosed embodiments, such as the "zero volt recovery (ZVR) circuit" of the '438 patent, be construed broadly to cover alternative technical approaches that achieve a similar result, or will they be limited by the patent's disclosure to the specific circuits shown?

  3. A third key question will concern knowledge and intent: to succeed on its claims for indirect and willful infringement, Plaintiff must prove that Defendant had the requisite knowledge of the patents and the intent to cause infringement. The complaint's general allegations will need to be substantiated with evidence of pre-suit notice or other facts demonstrating culpable conduct.