DCT
2:25-cv-12700
Boston Scientific Corp v. Stryker Corp
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Scientific Corporation (Delaware) and Relievant Medsystems, Inc. (Delaware)
- Defendant: Stryker Corporation (Michigan)
- Plaintiff’s Counsel: Arnold & Porter Kaye Scholer LLP
- Case Identification: 2:25-cv-12700, D.N.J., 12/11/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of New Jersey because Defendant has a regular and established place of business in the district, has committed acts of infringement there, and has expressly agreed to venue in the action.
- Core Dispute: Plaintiff alleges that Defendant’s OptaBlate BVN Basivertebral Nerve Ablation System infringes a patent related to methods for accessing and ablating the basivertebral nerve within a vertebral body to treat chronic pain.
- Technical Context: The technology concerns minimally invasive surgical instruments and methods for creating a curved path through vertebral bone to deliver radiofrequency energy to a specific nerve, a procedure known as basivertebral nerve ablation (BVNA).
- Key Procedural History: The complaint alleges that Defendant Stryker obtained 510(k) clearance from the FDA for its accused product by claiming it was "substantially equivalent" to Plaintiff's own Intracept® product. The complaint also asserts that Stryker, in an answer to a prior complaint, admitted it became aware of the patent-in-suit at or near its issue date, a fact relevant to the allegation of willful infringement. A related appeal between the parties is noted as pending before the U.S. Court of Appeals for the Federal Circuit.
Case Timeline
| Date | Event |
|---|---|
| 2008-09-26 | ’166 Patent Priority Date |
| 2023-11-17 | Boston Scientific acquires Relievant Medsystems |
| 2025-05-15 | Stryker receives FDA 510(k) clearance for OptaBlate BVN product |
| 2025-05-20 | U.S. Patent No. 12,303,166 Issues |
| 2025-07-02 | Original Complaint filed in the action |
| 2025-07-17 | Stryker introduces OptaBlate BVN product at ASPN Annual Meeting |
| 2025-11-01 | Stryker fully commercially launches OptaBlate BVN product (approx. date) |
| 2025-12-11 | First Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 12,303,166 - “Methods for Accessing Nerves Within Bone”
- Patent Identification: U.S. Patent No. 12,303,166, titled “Methods for Accessing Nerves Within Bone,” issued on May 20, 2025 (’166 Patent).
The Invention Explained
- Problem Addressed: The patent’s background section describes the difficulty in accurately and predictably placing a treatment device, such as a radiofrequency probe, into the posterior midline section of a vertebral body to treat the basivertebral nerve (BVN). This difficulty arises from the need to navigate through varying densities of cancellous bone, a task for which conventional straight-line surgical instruments are ill-suited (’166 Patent, col. 1:29-53). Creating a predictable curved path within bone is identified as a key technical challenge (’166 Patent, col. 2:1-10).
- The Patented Solution: The invention discloses systems and methods for creating a predictable curved channel in bone using a "tube-within-a-tube" approach. A first instrument, an "introducer" or trocar, creates an initial straight path. A second instrument, a cannula with a pre-formed curved tip made of a memory-retaining material, is delivered through the introducer. The cannula's tip is straightened while inside the introducer but regains its pre-formed curve upon exiting the introducer's distal end, thereby reliably creating a curved path inside the bone for a therapeutic device to follow (’166 Patent, Abstract; col. 5:25-50).
- Technical Importance: This method provides a reproducible technique for navigating to a specific, hard-to-reach nerve target deep within a vertebral body, enabling precise delivery of therapy for chronic back pain (Compl. ¶¶1, 21-22).
Key Claims at a Glance
- The complaint asserts independent method claims 16 and 21 (Compl. ¶¶54-55).
- Essential elements of independent claim 16 include:
- A method of ablating a basivertebral nerve in a vertebral body of a patient.
- Inserting an introducer through a pedicle of the vertebral body such that its opening reaches a cancellous portion, wherein a stylet is used to pierce bone.
- Delivering an instrument through the introducer, the instrument comprising a proximal portion, a distal deflectable section, and a rotatable element at the proximal portion.
- Configuring the distal deflectable section to penetrate the cancellous portion and form a curved path.
- Initiating a first rotation of the rotatable element, then advancing the distal deflectable section.
- A second rotation of the rotatable element occurring when the distal section is deployed at an angle of 5 to 90 degrees.
- Applying bipolar radiofrequency energy from a probe in the curved path to ablate the nerve.
- Essential elements of independent claim 21 include:
- A method of ablating a basivertebral nerve in a vertebral body of a patient.
- Selecting an introducer and instrument(s) after a pre-surgical evaluation.
- Inserting the introducer through a pedicle so its opening reaches a cancellous portion of a lumbar or sacral vertebral body.
- Delivering the instrument(s) through the introducer's central channel.
- Advancing the instrument's distal deflectable section past the introducer's opening to traverse the cancellous portion in a curved path to a target area.
- Delivering energy from a bipolar RF probe to ablate the nerve.
III. The Accused Instrumentality
Product Identification
- Stryker’s OptaBlate® BVN Basivertebral Nerve Ablation System ("OptaBlate BVN product") (Compl. ¶4).
Functionality and Market Context
- The OptaBlate BVN product is a medical device system intended for performing basivertebral nerve ablation to relieve chronic low back pain (Compl. ¶57). The complaint alleges the system includes an introducer (referred to as a "cannula"), one or more other instruments (referred to as an "introducer with conduit"), and is used with a radiofrequency generator (Compl. ¶¶50, 59, 61). Product marketing materials referenced in the complaint state the system is designed to provide a "controlled curve in the vertebral body" for improved targeting (Compl. p. 21, Figure). The complaint alleges the product was commercially launched in November 2025 and is one of only two products cleared by the FDA for this specific indication, the other being Plaintiff's Intracept® product (Compl. ¶¶32, 40). The complaint includes an image from Stryker's product brochure showing the system's components, including a generator console and various instruments (Compl. ¶59; p. 16, top fig.).
IV. Analysis of Infringement Allegations
’166 Patent Infringement Allegations
| Claim Element (from Independent Claim 16) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of ablating a basivertebral nerve in a vertebral body of a patient... | The OptaBlate BVN product is intended for use in a method of ablating a basivertebral nerve in a patient's vertebral body. | ¶57 | col. 19:40-42 |
| inserting an introducer through a pedicle of the vertebral body such that an opening at a distal tip of the introducer reaches a cancellous portion... | A physician inserts the introducer (cannula) through the pedicle into the cancellous portion of the vertebral body. A provided diagram shows this insertion path. | ¶62 | col. 19:43-50 |
| wherein inserting the introducer comprises inserting a stylet into the central channel of the introducer such that the stylet extends beyond the opening...and advancing the introducer and stylet simultaneously such that the stylet pierces bone... | A physician inserts a stylet into the introducer's central channel, extending it beyond the distal tip to pierce bone as the assembly is advanced. A diagram illustrates the stylet piercing bone. | ¶62 | col. 19:50-57 |
| delivering an instrument through the central channel of the introducer, the instrument comprising a proximal portion, a distal deflectable section, and a rotatable element at the proximal portion... | A physician delivers an instrument (identified as an "introducer with conduit") through the introducer. Diagrams show the instrument has a proximal portion, a distal deflectable section, and a rotatable element. | ¶¶61, 64 | col. 19:57-63 |
| wherein the distal deflectable section of the instrument is configured to penetrate the cancellous portion of the vertebral body to form a curved path... | The distal deflectable section is advanced past the introducer's tip to traverse the cancellous bone in a curved path. A diagram illustrates the instrument creating this path. | ¶65 | col. 19:64-67 |
| initiating a first rotation of the rotatable element; advancing the distal deflectable section...to a target area proximal to a junction of the basivertebral nerve... | The physician is alleged to initiate a first rotation of the rotatable element and advance the instrument's distal deflectable section to the target area near the basivertebral nerve junction. | ¶65 | col. 21:1-8 |
| wherein a second rotation of the rotatable element occurs when the distal deflectable section of the instrument is deployed at an angle of 5 degrees to 90 degrees... | A second rotation of the rotatable element allegedly deploys the distal section at an angle between 5 and 90 degrees. | ¶65 | col. 21:8-12 |
| applying bipolar radiofrequency energy between a first electrode and a second electrode of a bipolar RF probe disposed in the curved path...to ablate at least a portion of the basivertebral nerve. | A physician delivers energy from a bipolar RF probe's electrodes, which are located in the curved path, to ablate the nerve. A diagram shows the RF probe with two electrodes in the curved path. | ¶66 | col. 21:12-19 |
Identified Points of Contention
- Scope Questions: A potential issue may be whether the accused product components map to the claimed "introducer" and "instrument." The complaint identifies Stryker's "cannula" as the "introducer" and its "introducer with conduit" as the "instrument" (Compl. ¶¶60-61). The defense may question whether these are functionally distinct components as required by the claim or are better characterized as integrated parts of a single tool.
- Technical Questions: Claim 16 recites specific, sequential actions: "initiating a first rotation" and "a second rotation...occurs when the distal deflectable section...is deployed." The complaint alleges these steps occur (Compl. ¶65), but the provided evidence consists of static diagrams. A central technical question will be what evidence demonstrates that the accused procedure requires these two distinct rotational acts and that the second rotation is functionally tied to the deployment of the distal section to a specific angle, as opposed to being part of a continuous steering motion.
V. Key Claim Terms for Construction
The Term: "rotatable element"
- Context and Importance: This term is critical because claim 16 links infringement to a "first rotation" and a "second rotation" of this element, which corresponds to specific instrument deployment steps. Practitioners may focus on this term because its construction will determine whether a general-purpose steering knob on the accused device performs the specific functions required by the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification does not appear to provide an explicit definition for "rotatable element," which could support a construction encompassing any component at the instrument's proximal end that can be turned by the user to affect the distal end.
- Evidence for a Narrower Interpretation: The language of claim 16—"initiating a first rotation" and "a second rotation...occurs when the distal deflectable section...is deployed"—links the rotation to discrete events in the deployment sequence. This may support a narrower construction where the "rotatable element" is not merely a steering control but is part of a mechanism where distinct rotations cause specific deployment actions.
The Term: "instrument"
- Context and Importance: The claims consistently distinguish between an "introducer" that is first inserted and an "instrument" that is subsequently "deliver[ed] through the central channel of the introducer." The infringement case depends on showing the accused OptaBlate system uses two such separate components.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's abstract and detailed description consistently refer to an "introducer" and "one or more instruments," treating them as separate categories of components within the system (’166 Patent, Abstract; col. 5:32-34). This supports the plaintiff’s two-component infringement theory.
- Evidence for a Narrower Interpretation: A defendant may argue that in the context of a surgical kit, nested tools are common and that the term "instrument" should be construed to require a greater degree of separateness or functional independence than is present in its product, which it may characterize as a single, multi-part "introducer."
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b), asserting that Stryker provides customers with instructions, diagrams, brochures, and training that direct physicians to use the OptaBlate BVN product in a manner that practices the claimed methods (Compl. ¶¶5, 44, 48-50). It also alleges contributory infringement under § 271(c), stating the product is especially made for infringing use and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶¶5, 70).
- Willful Infringement: The complaint alleges Stryker had both constructive and actual notice of the ’166 Patent (Compl. ¶¶51-52). The allegation of willfulness is supported by the assertion that Stryker admitted in an answer to the original complaint that "it became aware of the '166 Patent at or near the time of its issue date," which predates the accused product's full commercial launch (Compl. ¶52). Plaintiff alleges Stryker's infringement has been "willful and deliberate" (Compl. ¶53).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of functional operation: Does the accused OptaBlate system’s "rotatable element" operate through the specific, sequential "first rotation" and "second rotation" steps recited in claim 16, or does it utilize a more general steering mechanism where rotation is not discretely tied to the instrument's deployment angle?
- The case will also present a question of component definition: Does the accused system, which includes a "cannula" and an "introducer with conduit," meet the claim requirement for a distinct "introducer" and a separate "instrument" delivered through it, or can these parts be properly characterized as a single, integrated tool?
- Regarding damages, a central question will be one of willfulness: Given the complaint’s allegation that Stryker admitted to early, pre-launch knowledge of the patent, did Stryker act with objective recklessness by launching its product, potentially justifying an award of enhanced damages?