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: 1:25-cv-05314, E.D.N.Y., 09/22/2025
• Venue Allegations: Plaintiff alleges venue is proper because Defendant resides and has a principal place of business in the district, and has committed alleged acts of infringement, including making, selling, and offering for sale the Accused Products within the district.
• Core Dispute: Plaintiff alleges that Defendant’s orogastric tubes, used for gastric sizing, infringe three patents related to systems and instruments for use in bariatric surgery.
• Technical Context: The technology concerns surgical instruments designed to improve the safety and accuracy of sleeve gastrectomy, a common bariatric procedure where a portion of the stomach is removed.
• Key Procedural History: The complaint alleges that Defendant had knowledge of the lead patent-in-suit since at least December 2018, when an application for Defendant’s own patent (U.S. Patent No. 11,006,957) was filed with an Information Disclosure Statement that cited the publication corresponding to the asserted ’533 Patent.

Case Timeline

Date	Event
2012-11-29	Earliest Patent Priority Date ('533, ’446, ’937 Patents)
2018-06-19	U.S. Patent No. 9,999,533 Issues
2018-12-24	Defendant's '957 Patent Application Filed (alleged knowledge date)
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's SIREN System receives 510(k) premarket clearance
2024-09-30	Defendant begins selling SIREN System (alleged as "no later than")
2025-01-10	Defendant's ZZIREN System receives 510(k) premarket clearance
2025-06-26	Plaintiff allegedly informs Defendant of infringement by letter
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 describes conventional sleeve gastrectomy procedures as relying on a simple sizing guide called a "Bougie," which required the use of multiple separate instruments, lacked functionality, and did not provide a clear visual guide for stomach resection (Compl. ¶17-18; ’533 Patent, col. 1:44-53).
• The Patented Solution: The invention is a single, integrated system centered on a flexible sizing tube with a specific arrangement of apertures at its distal end. When the tube is placed along the stomach's lesser curvature and controlled suction is applied, the device simultaneously evacuates gastric fluids and pulls the stomach wall into firm engagement with the tube. This action is intended to hold the tube in place and create a clear, visually perceptible line for the surgeon to follow during resection (’533 Patent, Abstract; col. 2:24-34).
• Technical Importance: This approach sought to integrate the functions of gastric sizing, evacuation, and surgical line delineation into a single instrument, potentially increasing the procedure's efficiency and safety (Compl. ¶18).

Key Claims at a Glance

• The complaint asserts infringement of at least Claim 1 (Compl. ¶32).
• Independent Claim 1 requires:
  • A system for sizing a patient's stomach.
  • A "one-piece device" configured for introduction into the stomach to be disposed along the lesser curvature.
  • The device consists of a sizing tube with a distal free end, a proximal end portion, and an elongated unitary tubular member with a hollow interior and a sidewall.
  • The sidewall has a portion configured to extend the entire length of the lesser curvature and is made of a "flexible non-expandable material."
  • The sidewall includes a "plurality of apertures" in an array extending about the "entire periphery" of the sidewall.
  • 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's periphery.
  • The controlled suction serves as the "sole means of holding said one-piece device in place" to be used as a guide for sizing.
• The complaint does not explicitly reserve the right to assert dependent claims.

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

The Invention Explained

• Problem Addressed: The patent addresses the same challenges as the ’533 Patent: the need for an integrated instrument that simplifies sleeve gastrectomy procedures and provides a reliable guide for stomach resection (’446 Patent, col. 1:29-53).
• The Patented Solution: The ’446 Patent claims a system that uses a non-expandable sizing tube with apertures to create a "suction-created visually perceptible delineation line" on the stomach's exterior. The claims focus on the functional outcome of applying controlled suction—not just engaging the stomach, but producing an external visual guide for the surgeon and anchoring the tube in place without any expandable member (’446 Patent, Abstract). The claims also quantify the suction force required to achieve this anchoring effect (’446 Patent, col. 22:19-29).
• Technical Importance: The invention is framed around the functional benefit of creating a reliable surgical guide via suction and specifies the physical forces involved, tying the structure to a tangible clinical outcome (Compl. ¶61-63).

Key Claims at a Glance

• The complaint asserts infringement of at least Claim 1 (Compl. ¶52).
• Independent Claim 1 requires:
  • A system for sizing a patient's stomach, 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 predetermined outside diameter.
  • The tube has a tip with an "unencumbered" distal end.
  • A "plurality of apertures" are disposed about the periphery of the distal end portion.
  • When controlled suction is applied through the apertures, it pulls the lesser curvature of the stomach into engagement and pulls other portions of the stomach towards the tube to "anchor said sizing tube in place without the use of any expandable member."
  • This action is "to produce a suction-created visually perceptible delineation line" on the stomach's exterior to serve as a guide.
  • The controlled suction serves as the "sole means anchoring said sizing tube in place."
  • The suction controller is configured to apply suction resulting in an anchoring force in a range of 0.05 to 200 pounds.
• The complaint does not explicitly reserve the right to assert dependent claims.

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

Multi-Patent Capsule

• Technology Synopsis: This patent, like the ’533 Patent, claims a gastric sizing system comprising a "one-piece" flexible sizing tube. The invention centers on using an array of apertures and controlled suction to engage the stomach's lesser curvature, thereby serving as both an anchor and a sizing guide for bariatric surgery (’937 Patent, Abstract).
• Asserted Claims: Claim 1 (Compl. ¶74).
• Accused Features: The complaint alleges that the ZZIREN SGT System’s physical structure as a one-piece sizing tube, its use of suction through side-hole arrays, and its intended function as a sizing guide for bariatric procedures infringe the ’937 Patent (Compl. ¶74-76).

III. The Accused Instrumentality

Product Identification

• The ZZIREN SGT and GBT Orogastric Tubes, and the SIREN SGT Orogastric Tubes (collectively, "Accused Products") (Compl. ¶2). The complaint states that the ZZIREN System "supersedes" the SIREN System and that the two are "substantially similar," focusing its technical allegations on the ZZIREN product (Compl. ¶24).

Functionality and Market Context

• The complaint alleges the ZZIREN System is a single-piece sizing tube made of flexible polyvinylchloride (PVC) (Compl. ¶34, 37). Marketing materials reproduced in the complaint show a device with a blunt tip, depth markings, and multiple side holes near the distal end for suction and decompression (Compl. at 7). The product's Instructions for Use (IFU) allegedly direct surgeons to insert the tube through the esophagus, position it within the stomach, and apply controlled suction (Compl. at 8, 12). The complaint alleges the ZZIREN System is specifically cleared for use as a sizing guide in bariatric procedures and that its IFU states the tube "adheres to the stomach when suction is applied" (Compl. ¶42, 53). An annotated figure provided by Plaintiff highlights the accused device's "unencumbered distal end" (Compl. at 17).

IV. Analysis of Infringement Allegations

9,999,533 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... with a portion of said one-piece device disposed along the lesser curvature...	The ZZIREN SGT System is alleged to be a one-piece sizing tube. Its IFU provides instructions for introducing it through the esophagus and positioning it in the stomach. Defendant's own patent allegedly describes placing the tube along the lesser curvature.	¶34	col. 2:10-16
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 these elements, as shown in annotated figures from the product's IFU which identify the "distal free end," "proximal end," "central longitudinal axis," and "sidewall." The image provided on page 8 of the complaint explicitly labels these features. (Compl. at 8).	¶35	col. 2:15-18
said sidewall including a portion configured for extending the entire length of the lesser curvature... and bent into a curved shape directly engaging the lesser curvature...	The ZZIREN SGT System is alleged to be formed of flexible PVC material that is able to bend into a curved shape to conform with the stomach's lesser curvature.	¶36-37	col. 2:21-24
said sidewall including a plurality of apertures extending through said sidewall, a group of said plurality of apertures being disposed in an array extending about the entire periphery of said sidewall...	The ZZIREN SGT System is alleged to have side hole arrays that surround the periphery of the tubular member, as shown in an annotated figure. Defendant's materials allegedly state the device has 32, 48, 72, or 108 side holes.	¶38	col. 2:18-24
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 SGT System's IFU allegedly includes instructions to couple the device to a vacuum source to apply controlled suction. The IFU is alleged to state that the distal end "adheres to the stomach when suction is applied."	¶41	col. 2:24-32
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 SGT System is alleged to be cleared for use as a sizing guide, and Plaintiff alleges that the adherence created by suction serves to hold the device in place for this purpose.	¶42	col. 2:32-34

10,888,446 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; [and] a non-expandable instrument configured to be coupled to said suction controller...	The ZZIREN System's IFU allegedly instructs users to set a vacuum source suction regulator to a specific level (125 mmHg), which Plaintiff alleges constitutes a suction controller. The instrument is allegedly made of flexible, non-expandable PVC. A diagram shows the coiled tube. (Compl. at 16).	¶54-55	col. 21:45-53
said sizing tube having... a tip having a distal end that is unencumbered.	An annotated figure from the ZZIREN System IFU is provided to show that the sizing tube's distal end is unencumbered. (Compl. at 17).	¶57	col. 21:56-61
controlled suction is applied... to pull the lesser curvature of the patient's stomach into engagement... and contemporaneously therewith to pull other portions of the patient's stomach... to anchor said sizing tube in place without the use of any expandable member...	The complaint alleges the ZZIREN System is used with controlled suction and that its IFU states the tube "adheres to the stomach when suction is applied," which allegedly anchors it in place.	¶60	col. 22:1-12
to produce a suction-created visually perceptible delineation line on the exterior of the patient's stomach... to serve as a guide... with said controlled suction... serving as the sole means anchoring said sizing tube in place.	Plaintiff alleges that the use of the ZZIREN System with suction meets this element because it is cleared as a sizing guide and adheres to the stomach, and that this adherence via suction is the sole means of anchoring.	¶61	col. 22:12-18
wherein said suction controller is configured to apply controlled suction... to result in a force in a range of 0.05 to 200 pounds anchoring said sizing tube...	The complaint alleges that based on a "calculat[ion]" comparing the number and size of holes in the ZZIREN System to Plaintiff's own product, the accused system falls within the claimed force range. The IFU's instructions for setting the suction regulator are also cited as support.	¶62-63	col. 22:19-23

Identified Points of Contention

• Scope Questions: A central dispute may arise over the meaning of "sole means" for anchoring or holding the device in place, as required by both asserted independent claims. Defendant may argue that factors other than suction—such as the surgeon's physical manipulation, the tube's inherent stiffness, or the natural anatomy of the stomach—contribute to the device's positioning, suggesting suction is not the "sole means."
• Technical Questions: The complaint's allegation that the ’446 Patent's claimed force range is met is based on a "calculat[ion]" comparing the accused device to the Plaintiff's own commercial embodiment (Compl. ¶63). This raises an evidentiary question of whether this comparison is technically sound and factually accurate for the accused product, which may require expert testimony and testing to resolve. A further technical question is whether the alleged "adherence" of the accused product to the stomach wall is sufficient to create the "suction-created visually perceptible delineation line" required by the '446 Patent.

V. Key Claim Terms for Construction

• The Term: "sole means of holding said one-piece device in place" (’533 Patent, Claim 1) and "sole means anchoring said sizing tube in place" (’446 Patent, Claim 1)

• Context and Importance: The construction of this term is critical because it defines the primary function of the claimed suction. If "sole means" is interpreted strictly, Defendant could potentially avoid infringement by showing that any other force or factor contributes to holding the sizing tube in its functional position during surgery. Practitioners may focus on this term because it appears to be a significant potential limitation on claim scope.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification's abstract states the invention "enables suction to be applied... to bring adjacent portions of the patient's stomach into engagement [with] the sizing tube" (’533 Patent, Abstract). Parties may argue this emphasis on "engagement" implies that suction is the only claimed mechanism actively creating the anchoring force, even if other passive factors (like anatomy) exist.
  • Evidence for a Narrower Interpretation: The claim language itself, by using the restrictive word "sole," provides strong evidence for a narrow interpretation. The specification describes the plurality of apertures as extending along a "sufficient portion of the length of the sizing tube to hold the sizing tube in place when the controlled suction is applied," which may be argued to reinforce the singular importance of suction for this function (’533 Patent, col. 2:32-34).

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

• Context and Importance: This term describes the required outcome of applying suction. The dispute will likely center on what level of clarity and precision is required for a "line" to be "visually perceptible" for use as a surgical guide. The existence and quality of this line is a factual question tied to the claim's scope.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent states that suction brings adjacent portions of the stomach into "close engagement with portions of the periphery of the sizing tube," which would inherently create some form of boundary or line (’446 Patent, col. 4:42-45). This may support an argument that any discernible boundary created by suction meets the limitation.
  • Evidence for a Narrower Interpretation: The specification refers to providing a "good visual indication of the line along which the stomach is to be resected" and a "clear line of delineation or demarcation" (’446 Patent, col. 1:66-2:2; col. 10:56-59). This language suggests the line must be of sufficient quality to reliably guide a surgical instrument, potentially supporting a narrower construction that requires more than a vague or indistinct boundary.

VI. Other Allegations

• Indirect Infringement: The complaint does not contain a separate count for indirect infringement but alleges acts that may support it. The complaint alleges that Defendant's IFU and marketing materials instruct and encourage medical professionals to use the Accused Products in a manner that directly infringes the asserted patents, for example by directing users to apply suction to the device when it is placed along the lesser curvature of the stomach (Compl. ¶41, 54, 60).
• Willful Infringement: The complaint alleges willful infringement based on both pre- and post-suit knowledge (Compl. ¶44, 66, 87). Pre-suit knowledge of the ’533 Patent is alleged to have begun no later than December 24, 2018, the filing date of an application for Defendant's own patent, because the attorney prosecuting that application allegedly included the ’533 Patent's publication in an Information Disclosure Statement (Compl. ¶29). Knowledge of all three asserted patents is also alleged based on a notice letter sent by Plaintiff on June 26, 2025 (Compl. ¶30, 50, 72). Willfulness is further alleged based on "apparent copying of Plaintiffs' patented ViSiGi 3D® product" (Compl. ¶44).

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

• A core issue will be one of functional performance: Does the suction applied through the accused ZZIREN system perform the specific, dual functions required by the claims—serving as the "sole means" of anchoring the tube and creating a "visually perceptible delineation line"—or does it primarily serve a drainage function with stomach adherence being an incidental and insufficient effect to meet the claim limitations?
• A second key issue will turn on willfulness and pre-suit knowledge: Can knowledge of a patent be imputed to a defendant for the purposes of willfulness based on its patent prosecutor's citation of the corresponding publication in an IDS for an unrelated patent, and does this act, if proven, rise to the level of egregious conduct required for enhanced damages?