Boston Scientific Corp v. Atraverse Medical Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Boston Scientific Corporation (Delaware) and Boston Scientific Medical Device Limited (Ireland)
  • Defendant: Atraverse Medical, Inc. (Delaware)
  • Plaintiff’s Counsel: Fish & Richardson P.C.
• Case Identification: 1:25-cv-01035, D. Del., 10/09/2025
• 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 HOTWIRE™ radiofrequency guidewire infringes patents related to medical devices for puncturing tissue during transseptal cardiac procedures.
• Technical Context: The technology involves guidewires that use electrical energy to create a puncture through tissue, such as the heart's septum, to provide access for other therapeutic devices, a common step in many minimally invasive cardiac procedures.
• Key Procedural History: The complaint alleges Defendant was aware of the asserted patent family prior to the lawsuit, having cited a parent patent during the prosecution of its own patent application. Plaintiff also sent a cease and desist letter after filing an initial complaint, providing Defendant with pre-issuance notice of the second patent-in-suit, which may be relevant to the allegations of willful infringement.

Case Timeline

Date	Event
2013-08-07	U.S. Patent Nos. 11,998,238 and 12,433,639 Priority Date
2024-03-XX	Defendant allegedly cites parent of Asserted Patents during its own prosecution
2024-05-XX	Accused HOTWIRE™ device receives FDA 510(k) clearance
2024-06-04	U.S. Patent No. 11998238 Issues
2024-09-XX	Defendant begins commercial clinical use of the Accused HOTWIRE™ device
2025-08-18	Plaintiff files initial complaint against Defendant
2025-08-20	Plaintiff sends cease and desist letter to Defendant
2025-10-07	U.S. Patent No. 12433639 Issues
2025-10-09	Amended Complaint Filed

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

U.S. Patent No. 11,998,238 - "Methods and Devices for Puncturing Tissue"

• Patent Identification: U.S. Patent No. 11,998,238, "Methods and Devices for Puncturing Tissue," issued June 4, 2024 (’238 Patent).

The Invention Explained

• Problem Addressed: The patent describes the difficulty of delivering treatment tools to a specific tissue site, such as the heart's septum, when vascular access is restricted. Navigating tortuous anatomy often requires steerable sheaths, but the stiffness of accessory devices (like dilators) inserted through them can impair the sheath's ability to bend, limiting access and potentially requiring multiple, inefficient device exchanges. (’238 Patent, col. 3:6-41).
• The Patented Solution: The invention is a "hybrid" guidewire designed to both puncture tissue and serve as a stable rail for other devices. It features an active tip that delivers energy (e.g., radiofrequency) to create a puncture, and a main body ("rail section") that is flexible enough to navigate to the target site yet stiff enough to support subsequent devices. A key aspect is the distal section, which is configured to automatically form a coil after passing through the puncture, anchoring the guidewire and orienting the active tip away from tissue to prevent inadvertent damage. (’238 Patent, Abstract; col. 2:26-52).
• Technical Importance: This design aims to improve the safety and efficiency of transseptal procedures by combining the puncture, anchoring, and rail functions into a single device, thereby reducing the number of device exchanges required. (Compl. ¶12).

Key Claims at a Glance

• The complaint asserts at least independent claim 1. (Compl. ¶17).
• Claim 1 Elements:
  • A medical device for puncturing tissue at a tissue site
  • Comprising an elongate member with a proximal section, a distal section, and a rail section between them
  • An active tip at the distal end operable to deliver energy for the puncture
  • The rail section is configured to act as a rail for other tubular members and is maneuverable to access the site
  • The distal section defines a curved portion and a straight portion, with the straight portion being distal to the curved portion
  • The distal straight portion has a "reverse taper," where its outer diameter increases in a distal direction
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,433,639 - "Methods and Devices for Puncturing Tissue"

• Patent Identification: U.S. Patent No. 12,433,639, "Methods and Devices for Puncturing Tissue," issued October 7, 2025 (’639 Patent).

The Invention Explained

• Problem Addressed: Similar to the ’238 Patent, this patent addresses challenges in transseptal access, where fixed-curve or steerable sheaths may be unable to reach or maintain a desired curvature due to the stiffness of the dilators and guidewires passed through them. (’639 Patent, col. 3:24-42).
• The Patented Solution: The invention is a guidewire-based device with specific geometric properties designed to facilitate RF puncture and subsequent device delivery. Like the ’238 patent, it features an energy-delivering tip and a distal section that forms an anchor (a "J-shape" or coil) after crossing the tissue. The claims focus on the specific relative diameters of the wire in its straight and curved distal portions, a design intended to provide stability during and after puncture. (’639 Patent, Abstract; col. 13:30-44).
• Technical Importance: By defining specific wire geometries, the invention aims to create a reliable device that can be steered to a puncture site, safely create an opening with RF energy, and then provide a stable platform for therapeutic device delivery. (Compl. ¶12).

Key Claims at a Glance

• The complaint asserts at least independent claims 1 and 20. (Compl. ¶23).
• Claim 1 Elements:
  • A medical device for puncturing a heart septum
  • Comprising an elongate member (wire) with a proximal section, distal section (with electrode), and rail section
  • The electrode is operable to deliver energy to create a puncture
  • The distal section has a curved portion and a straight portion (distal to the curved portion)
  • The outer diameter of the wire at the distal end of the straight portion is greater than the outer diameter of the wire at the distal end of the curved portion
  • The distal section is configured to automatically form a J-shape for anchoring
• Claim 20 Elements:
  • A medical device for puncturing a heart septum
  • Comprising an elongate member (wire) with proximal, distal (with electrode), and rail sections
  • The electrode is operable to deliver energy to create a puncture
  • The distal section has a curved portion and a straight portion (distal to the curved portion)
  • The outer diameter of the wire at the distal end of the straight portion is greater than the outer diameter of the wire at the distal end of the curved portion
  • The curved portion is configured such that upon deployment, the distal end of the straight portion curves away from the axis of advancement
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

III. The Accused Instrumentality

Product Identification

• The Atraverse Medical, Inc. HOTWIRE™ device. (Compl. ¶13).

Functionality and Market Context

• The complaint, citing Defendant's FDA 510(k) filings, describes the HOTWIRE™ as a "sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart." (Compl. ¶13).
• Plaintiff alleges the device has been offered for sale and sold in the U.S. since receiving FDA clearance in May 2024 and has been used in commercial clinical cases since at least September 2024, generating revenue for the Defendant. (Compl. ¶14).

IV. Analysis of Infringement Allegations

The complaint alleges that the accused HOTWIRE™ device infringes the asserted claims of the ’238 and ’639 patents, incorporating by reference detailed claim charts as Exhibits B and D. (Compl. ¶¶ 17, 23). As these exhibits were not filed with the complaint document itself, the specific factual basis for how each claim element is met by the accused device is not detailed in the body of the pleading. The narrative infringement theory is that Defendant's acts of making, using, selling, offering for sale, and importing the HOTWIRE™ device constitute direct infringement. (Compl. ¶¶ 17, 23).

No probative visual evidence provided in complaint.

• Identified Points of Contention:
  • Structural Questions: The infringement analysis for both patents will likely depend on the precise physical construction of the HOTWIRE™ device's distal tip. The complaint does not provide sufficient detail for analysis of these features.
    • For the ’238 Patent, a central question may be whether the HOTWIRE™ device incorporates a "reverse taper" on its distal straight portion, as required by claim 1.
    • For the ’639 Patent, a key factual question will be whether the outer diameter of the wire at the distal end of the straight portion is greater than the outer diameter at the distal end of the curved portion, as required by claims 1 and 20.
  • Functional Questions: A further point of contention may be whether the HOTWIRE™ device, upon being advanced through tissue, automatically forms a "J-shape" or coil that functions as an anchor and orients the electrode tip "away from the axis of advancement" in the manner required by the claims.

V. Key Claim Terms for Construction

• The Term: "reverse taper" (’238 Patent, claim 1)
• Context and Importance: This term defines a specific geometric feature of the distal straight portion of the device. The infringement determination for claim 1 of the ’238 Patent will likely hinge on whether the accused HOTWIRE™ device possesses a structure that meets the court's construction of this term.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification does not appear to provide an explicit definition. A party could argue that any distal increase in diameter, regardless of its shape or continuity, constitutes a "reverse taper."
  • Evidence for a Narrower Interpretation: The specification notes that in one embodiment, "wire 212 flares out distally (or has a reverse taper)." (’238 Patent, col. 19:23-25). A party may argue this language, combined with the ordinary meaning of "taper," requires a gradual, conical increase in diameter, rather than an abrupt step-up.
• The Term: "wherein an outer diameter of the wire in the straight portion at a distal end of the straight portion is greater than an outer diameter of the wire in the curved portion at a distal end of the curved portion" (’639 Patent, claim 1)
• Context and Importance: This limitation defines the relative dimensions of two different parts of the device's distal tip. Proving infringement of claims 1 and 20 of the ’639 Patent will require evidence that the accused device meets this precise dimensional relationship.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: A party may argue that "at a distal end" refers to a region or section near the end, allowing for a comparison of average or maximum diameters within those regions rather than at a single infinitesimal point.
  • Evidence for a Narrower Interpretation: A party could argue that "at a distal end" refers to the very terminus of each respective portion of the wire. The patent's figures, such as FIG. 5F, which show changes in wire diameter along the straight portion, may be used by both parties to argue for a construction that favors their position based on where the measurement points should be located. (’639 Patent, Fig. 5F).

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement by asserting that Defendant instructs and encourages physicians to use the HOTWIRE™ device in its intended, infringing manner for transseptal procedures. This is supported by a quote attributed to Defendant's CEO describing the device's use to "denature the tissue and gently advance across." (Compl. ¶¶ 18, 24).
• Willful Infringement: Willfulness is alleged for both patents.
  • For the ’238 Patent, the complaint alleges pre-suit knowledge based on Defendant's citation to the parent patent during its own patent prosecution in March 2024, and on its CEO’s public statements acknowledging the "first mover" in the space, which was acquired by Plaintiff. (Compl. ¶¶ 19-20).
  • For the ’639 Patent, the complaint alleges knowledge based on a cease and desist letter sent on August 20, 2025, which explicitly informed Defendant of Plaintiff's "forthcoming patent based on the currently allowed claims" that would later issue as the ’639 Patent. (Compl. ¶¶ 25-26).

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

• A core issue will be one of structural correspondence: does the accused HOTWIRE™ device possess the specific, detailed geometric configurations required by the asserted claims, including the "reverse taper" of the ’238 patent and the precise relative wire diameters recited in the ’639 patent? The complaint's lack of specific factual allegations on these points suggests this will be a central area of discovery and dispute.
• A key evidentiary question will be one of functional operation: does the distal tip of the accused HOTWIRE™ automatically form a coiled or J-shaped anchor upon deployment through tissue, and does that anchor orient the energy-delivering electrode away from the axis of advancement as described in the patents, or does it operate in a fundamentally different manner?
• A central legal question will concern willfulness: given the allegations that Defendant cited the parent patent family during its own prosecution and received explicit pre-issuance notice of the ’639 patent’s allowed claims, the court will need to examine what evidence supports Defendant’s state of mind regarding the risk of infringement both before and after the suit was filed.