Boehringer Tech LLC v. Tools for Surgery LLC

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Boehringer Technologies, LLC; Boehringer Laboratories, Inc.; and Boehringer Laboratories, LLC (Pennsylvania)
  • Defendant: Tools for Surgery, LLC (New York)
  • Plaintiff’s Counsel: Troutman Pepper Locke LLP
• Case Identification: 2:25-cv-05314, E.D.N.Y., 09/22/2025
• Venue Allegations: Venue is alleged to be proper because the Defendant resides and has a principal place of business in the Eastern District of New York and has allegedly committed acts of infringement in the district.
• Core Dispute: Plaintiff alleges that Defendant’s orogastric tubes, used as gastric sizing guides in bariatric surgery, infringe three patents related to systems that use suction to position and stabilize a surgical instrument.
• Technical Context: The technology concerns medical devices used in sleeve gastrectomy procedures to guide the resection of the stomach, aiming to improve upon traditional methods by integrating sizing, stabilization, and drainage functions into a single instrument.
• Key Procedural History: The complaint alleges that during the prosecution of its own patent, Defendant cited the patent publication that later issued as the ’533 Patent-in-suit, which may be used to argue pre-suit knowledge of that patent. The complaint also references notice letters sent to the Defendant regarding all three asserted patents.

Case Timeline

Date	Event
2012-11-29	Earliest Priority Date for ’533, ’446, and ’937 Patents
2018-06-19	U.S. Patent No. 9,999,533 Issues
2018-12-24	Defendant's patent application is filed, citing the '533 Patent's publication
2021-01-12	U.S. Patent No. 10,888,446 Issues
2021-03-02	U.S. Patent No. 10,932,937 Issues
2022-05-18	Defendant receives 510(k) clearance for SIREN System
2024-09-30	Defendant begins selling/offering SIREN System (alleged "no later than" date)
2025-01-10	Defendant receives 510(k) clearance for ZZIREN System
2025-06-26	Plaintiff allegedly informs Defendant by letter of infringement
2025-09-22	Complaint Filed

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

U.S. Patent No. 9,999,533 - "Gastric Sizing Systems Including Instruments For Use In Bariatric Surgery"

The Invention Explained

• Problem Addressed: The patent's background describes prior art sleeve gastrectomy procedures, which often used a simple sizing guide called a "Bougie," as requiring multiple separate instruments. This approach could increase procedural risk and duration and failed to provide a clear visual guide for where the stomach should be resected (’533 Patent, col. 1:52-67).
• The Patented Solution: The invention is a single, flexible, one-piece sizing tube designed for introduction into the stomach. The tube features a distal end with a large number of apertures that, when coupled to a suction source, not only drain gastric fluids but also cause the tube to adhere to the stomach wall along the lesser curvature. This adherence is intended to hold the tube securely in place and create a distinct visual "delineation line" for the surgeon to follow during resection (’533 Patent, Abstract; col. 2:10-34).
• Technical Importance: The technology aims to consolidate the functions of sizing, stabilization, suction/drainage, and visual guidance into a single instrument to make sleeve gastrectomy procedures simpler and more reliable (’533 Patent, col. 2:1-4).

Key Claims at a Glance

• The complaint asserts independent Claim 1 (Compl. ¶32).
• The essential elements of Claim 1 include:
  • A one-piece device consisting of a sizing tube with a distal free end, a proximal end, and an elongated tubular member with a hollow interior and a sidewall.
  • The sidewall has a portion configured to extend along and be bent into a curved shape to directly engage the entire length of the stomach's lesser curvature.
  • The sidewall is made of a flexible, non-expandable material.
  • The sidewall includes a plurality of apertures disposed in an array extending about its entire periphery.
  • The device is configured to be coupled to a suction source to apply suction through the aperture array, bringing portions of the stomach into close engagement with the device.
  • The controlled suction serves as the "sole means" of holding the device in place in its curved shape against the lesser curvature.
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,888,446 - "Systems and Methods of Performing Bariatric Surgery"

The Invention Explained

• Problem Addressed: Similar to the ’533 Patent, the ’446 Patent addresses the shortcomings of prior art bariatric surgery instruments, which lacked integration of necessary functions and failed to provide a clear, stable guide for stomach resection (’446 Patent, col. 1:52-67).
• The Patented Solution: The invention is a system comprising both a "suction controller" and a "non-expandable instrument" (the sizing tube). The system is designed to apply a controlled amount of suction to create a "suction-created visually perceptible delineation line" on the stomach's exterior. The claims add specific quantitative ranges for the total anchoring force (0.05 to 200 pounds) and the suction force per unit length (0.02 to 21 pounds per inch) (’446 Patent, Abstract; col. 3:15-29).
• Technical Importance: This approach introduces quantitative control and specific performance parameters for the suction force, aiming to standardize the creation of the surgical guide and enhance procedural consistency (’446 Patent, col. 4:46-56).

Key Claims at a Glance

• The complaint asserts independent Claim 1 (Compl. ¶52).
• The essential elements of Claim 1 include:
  • A system comprising a "suction controller" and a "non-expandable instrument" (sizing tube).
  • The sizing tube is a single elongated member of flexible, non-expandable material, with a hollow interior, an unencumbered distal tip, and a plurality of apertures near the distal end.
  • Controlled suction is applied through the apertures to pull the lesser curvature of the stomach into engagement with the tube and anchor it in place "without the use of any expandable member."
  • The suction produces a "suction-created visually perceptible delineation line" on the stomach's exterior to serve as a guide.
  • The suction controller is configured to apply suction resulting in a total anchoring force between 0.05 and 200 pounds.
  • The sizing tube is configured to apply a suction force per unit length between 0.02 and 21 pounds per inch.
• The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,932,937 - "Gastric Sizing Systems Including Instruments For Use In Bariatric Surgery"

Technology Synopsis

This patent describes a gastric sizing system for bariatric procedures, focusing on a flexible sizing tube with an array of apertures at its distal end. The invention solves the problem of creating a stable surgical guide by using controlled suction to make the tube adhere to the stomach's lesser curvature, thereby creating a visual line for resection and holding the instrument in place (’937 Patent, Abstract; col. 2:10-35).

Asserted Claims

Independent Claim 1 (Compl. ¶74).

Accused Features

The ZZIREN SGT System is accused of infringing by being a sizing tube with a specific physical structure (distal free end, proximal end, sidewall with apertures) that uses controlled suction to engage the stomach's lesser curvature and function as a surgical guide, allegedly meeting all limitations of the asserted claim (Compl. ¶¶75-85).

III. The Accused Instrumentality

Product Identification

• The ZZIREN SGT and GBT Orogastric Tubes (collectively, the "ZZIREN System") and the SIREN SGT Orogastric Tubes (Compl. ¶1). The complaint focuses its technical allegations on the ZZIREN System.

Functionality and Market Context

• The complaint alleges the ZZIREN System is an orogastric tube used as a sizing guide in bariatric procedures (Compl. ¶33). It is described as a single, one-piece device made of flexible polyvinylchloride (PVC) (Compl. ¶¶34, 37). Marketing materials reproduced in the complaint show a coiled tube with features including a "blunt tip," "multiple side holes" for decompression near the distal end, and "prominent numerical markings" to indicate insertion depth (Compl. p. 7). The device is designed to be inserted through the esophagus, positioned along the lesser curvature of the stomach, and coupled to a suction source (Compl. ¶¶34, 41). An annotated diagram in the complaint illustrates the device's "distal free end," "proximal end portion," "sidewall," and "central longitudinal axis" (Compl. p. 8).
• The complaint states that the ZZIREN System received 510(k) premarket clearance on January 10, 2025, and that it "supersedes" the earlier SIREN System (Compl. ¶¶22, 24).

IV. Analysis of Infringement Allegations

’533 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a one-piece device configured for introduction through the esophagus into the patient's stomach	The ZZIREN SGT System is a one-piece sizing tube introduced through the esophagus.	¶34	col. 2:11-13
said one-piece device consisting of a sizing tube, said sizing tube comprising a distal free end; a proximal end portion; and an elongated unitary tubular member having a central longitudinal axis, a hollow interior... and a sidewall	The ZZIREN SGT System is alleged to comprise all these structural components, as shown in annotated figures.	¶35	col. 2:15-18
said sidewall including a portion configured for extending the entire length of the lesser curvature of the patient's stomach and bent into a curved shape directly engaging the lesser curvature of the patient's stomach	The ZZIREN System is allegedly able to bend into a curved shape to conform with and engage the lesser curvature of the stomach.	¶¶36-37	col. 2:18-23
said sidewall including a plurality of apertures... disposed in an array extending about the entire periphery of said sidewall	The ZZIREN System's side hole arrays allegedly surround the periphery of the tubular member.	¶38	col. 2:18-20
said one-piece device being configured to be coupled to a source of suction... to bring those portions of the patient's stomach into close engagement with the periphery of said one-piece device	The ZZIREN System is coupled to a suction source, and the IFU allegedly states the tube "adheres to the stomach when suction is applied."	¶41	col. 2:24-31
whereupon said one-piece device can be used as a guide... said controlled suction as applied by said array serving as the sole means of holding said one-piece device in place...	The ZZIREN System is allegedly cleared for use as a sizing guide, and the applied suction causes it to adhere to the stomach, which allegedly serves as the sole means of holding it in place.	¶42	col. 2:31-34

’446 Patent Infringement Allegations

Claim Element (from Independent Claim 1)	Alleged Infringing Functionality	Complaint Citation	Patent Citation
a suction controller configured for producing controlled suction from a source of suction	The ZZIREN System's IFU allegedly includes instructions for producing controlled suction by setting a vacuum source suction regulator.	¶54	col. 3:13-17
a non-expandable instrument... being a single elongated member forming a sizing tube formed of a flexible non-expandable material	The ZZIREN System is described as a single elongated member formed of flexible and non-expandable PVC.	¶55	col. 2:11-16
said sizing tube having... a tip having a distal end that is unencumbered, and a plurality of apertures disposed about the periphery of said distal end portion	The ZZIREN System allegedly has an unencumbered distal end and side hole arrays disposed around the periphery of its distal end portion.	¶¶57-58	col. 2:16-18
whereupon controlled suction is applied... to pull the lesser curvature of the patient's stomach into engagement... to anchor said sizing tube in place without the use of any expandable member	The accused system allegedly uses controlled suction to make the tube adhere to the stomach, thereby anchoring it.	¶60	col. 4:51-54
to produce a suction-created visually perceptible delineation line on the exterior of the patient's stomach... to serve as a guide	Use of the ZZIREN System allegedly meets this element when suction is applied, causing the tube to adhere to the stomach and serve as a sizing guide.	¶61	col. 4:46-52
wherein said suction controller is configured to apply controlled suction... to result in a force in a range of 0.05 to 200 pounds	The complaint alleges that based on a calculation comparing the ZZIREN System to the Plaintiff's product, the accused system falls within this force range.	¶62	col. 3:17-20

Identified Points of Contention

• Scope Questions: A potential point of contention for the ’533 Patent is the "sole means" limitation. The analysis may raise the question of whether the physical positioning and inherent stiffness of the accused tube contribute to holding it in place, which could suggest that suction is not the "sole means" as required by the claim (Compl. ¶42).
• Technical Questions: For the ’446 Patent, the complaint alleges the accused product meets specific claimed force ranges (e.g., 0.05 to 200 pounds) based on a calculation derived from its similarity to Plaintiff's own device (Compl. ¶¶62, 64). A key technical question is whether direct evidence will show that the accused product actually operates within these numerically-defined force ranges under typical surgical conditions.

V. Key Claim Terms for Construction

The Term: "sole means" (from ’533 Patent, Claim 1)

• Context and Importance: This term is central to the infringement analysis for the ’533 Patent. If mechanisms other than suction (e.g., friction, the device's physical shape, surgical positioning) are found to contribute to "holding said one-piece device in place," infringement of this limitation might be contested. Practitioners may focus on this term because it appears to be a potential narrowing feature of the claim.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification's summary emphasizes that suction is applied "to hold the sizing tube in place" (’533 Patent, col. 2:32-34). A party could argue "sole means" refers to the only active anchoring force applied, as distinct from passive physical properties.
  • Evidence for a Narrower Interpretation: The claim requires the device to be held "in said curved shape against the lesser curvature." A party could argue the physical act of disposing the tube along the curvature (’533 Patent, col. 2:13-15) is a contributing means of positioning, making suction not the "sole" means.

The Term: "suction-created visually perceptible delineation line" (from ’446 Patent, Claim 1)

• Context and Importance: Infringement of the ’446 Patent depends on whether the accused system produces this claimed result. The dispute will likely focus on what qualifies as a "delineation line" and whether the complaint provides sufficient evidence that the accused device creates one via suction.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The patent describes the invention's purpose as providing "a good visual indication of the line along which the stomach is to be resected" (’446 Patent, col. 2:1-2). This suggests any suction-induced visual guide on the stomach's exterior that achieves this purpose could meet the limitation.
  • Evidence for a Narrower Interpretation: The term "delineation line" could be construed to require a distinct, sharp, and continuous line, not merely a general impression of the tube's location. The patent links this line to enabling the stomach "to be sized" (’446 Patent, col. 2:31), suggesting a level of precision that a mere impression might not provide.

VI. Other Allegations

Indirect Infringement

• The complaint does not contain a separate count for indirect infringement, but the factual allegations suggest a basis for it. It alleges that Defendant's Instructions For Use (IFU) for the ZZIREN System instruct surgeons on coupling the device to a suction source and positioning it for use as a sizing guide, which allegedly directs users to perform the infringing steps (Compl. ¶¶41, 54, 60).

Willful Infringement

• The complaint alleges willful infringement based on both pre-suit and post-suit knowledge. Pre-suit knowledge of the ’533 Patent is alleged to have existed since at least December 24, 2018, based on Defendant's citation to the ’533 Patent's publication in an Information Disclosure Statement during the prosecution of its own patent (Compl. ¶29). Post-suit knowledge for all three patents is alleged based on a notice letter sent to Defendant on June 26, 2025 (Compl. ¶¶30, 50, 72). The complaint further supports willfulness by alleging "apparent copying" of Plaintiff's commercial product (Compl. ¶44).

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

• A core issue will be one of functional exclusivity: Can the term "sole means," as used in the ’533 Patent to describe how suction holds the device in place, be satisfied if the accused product's stability also relies on its physical properties and the surgeon's initial placement, or does the claim require suction to be the only factor preventing movement?
• A key evidentiary question will be one of quantitative proof: Does the accused system generate anchoring forces within the specific numerical ranges recited in the ’446 Patent? The case may turn on whether Plaintiff's infringement theory, which is based on a calculation comparing the accused product to its own, can be substantiated with direct testing and evidence from the accused device's actual operation.
• A central question for damages will be scienter: Does the Defendant's citation to the ’533 Patent's publication during its own patent prosecution, years before the suit was filed, constitute the kind of pre-suit knowledge and deliberate conduct that would support a finding of willful infringement?