DCT

2:25-cv-03229

Boehringer Tech LLC v. Tools for Surgery LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:25-cv-03229, E.D. Pa., 06/25/2025
  • Venue Allegations: Venue is alleged to be proper in the Eastern District of Pennsylvania because Plaintiffs reside and maintain a principal place of business in the district, and Defendant is alleged to have committed acts of infringement by selling or offering to sell accused products within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Siren SGT and ZZIREN SGT orogastric tubes, used in bariatric surgery, infringe six patents related to gastric sizing instruments that employ suction to conform to the stomach's lesser curvature and provide a visual guide for resection.
  • Technical Context: The technology pertains to surgical instruments for sleeve gastrectomy, a bariatric procedure that reduces stomach size, where precise sizing and clear visualization of the resection line are critical for patient outcomes.
  • Key Procedural History: The complaint alleges that Defendant was aware of the patents-in-suit as early as December 2018, when an attorney for Defendant’s president cited the ’368 and ’533 patents in an Information Disclosure Statement during the prosecution of a separate patent. The complaint further alleges that Defendant obtained FDA 510(k) premarket approval for its accused products based on a finding of "Substantial Equivalence" to Plaintiff's commercial product, which embodies the patented technology.

Case Timeline

Date Event
2012-11-29 Earliest Priority Date for all Patents-in-Suit
2017-11-07 U.S. Patent 9,808,368 Issues
2018-06-19 U.S. Patent 9,999,533 Issues
2018-12-24 Defendant’s Alleged Awareness of Patents via IDS Filing
2020-12-08 Defendant’s Alleged Awareness of Patents via USPTO Citation
2021-01-12 U.S. Patent 10,888,446 Issues
2021-03-02 U.S. Patent 10,932,937 Issues
2022-05-18 FDA 510(k) Premarket Approval for Siren SGT Device
2022-11-29 U.S. Patent 11,511,030 Issues
2025-01-10 FDA 510(k) Premarket Approval for ZZIREN SGT Device
2025-05-20 U.S. Patent 12,303,415 Issues
2025-06-25 Complaint Filed

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

U.S. Patent No. 9,808,368 - "Methods For Performing Bariatric Surgery Using Gastric Sizing Systems And Instruments"

The Invention Explained

  • Problem Addressed: The patent’s background section notes that prior art instruments for sleeve gastrectomy, such as a Bougie (esophageal dilator), leave "much to be desired" in providing a "good visual indication of the line along which the stomach is to be resected" and are not well-integrated with other necessary surgical functions (’446 Patent, col. 1:51 - col. 2:2).
  • The Patented Solution: The invention is a method using a flexible sizing tube with numerous apertures near its tip. When placed along the stomach's lesser curvature and connected to a suction source, the tube adheres to the stomach wall. This action is claimed to hold the tube in place and create a "visually perceptible delineation line" on the exterior of the stomach, which serves as a clear guide for the surgeon to perform the resection, as illustrated in the patent's figures (’368 Patent, Abstract; ’446 Patent, Fig. 5).
  • Technical Importance: This approach integrates stomach decompression, sizing, and visual guidance into a single instrument, aiming to improve the accuracy and efficiency of sleeve gastrectomy procedures (’446 Patent, col. 2:4-6).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (’368 Patent, Claim 1; Compl. ¶21).
  • The essential elements of this method claim include:
    • Providing a non-expandable instrument comprising a sizing tube with a hollow interior and a plurality of apertures at its distal end.
    • Introducing the tube into the stomach so it extends along and engages the lesser curvature.
    • Connecting the tube to a suction source and applying controlled suction through the apertures to pull the stomach wall into engagement with the tube.
    • Producing a "suction-created visually perceptible delineation line" on the stomach's exterior without using any expandable member.
    • Visualizing this line with a laparoscope.
    • Maintaining suction while laparoscopically sealing the stomach adjacent to the delineation line.
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

The Invention Explained

  • Problem Addressed: As with the ’368 Patent, this patent addresses the need for an improved surgical instrument for sleeve gastrectomy that provides better guidance and stability than traditional Bougies (’446 Patent, col. 1:51 - col. 2:2).
  • The Patented Solution: This patent claims the sizing system itself, rather than the method of use. The invention is a "one-piece device" consisting of a flexible, non-expandable sizing tube with a specific sidewall configuration. The sidewall includes a portion bent into a curved shape to directly engage the lesser curvature of the stomach, with an array of apertures that allow suction to serve as the "sole means of holding" the device in place against the stomach wall (’533 Patent, Abstract, Claim 1).
  • Technical Importance: By claiming the specific structure of a device that uses suction as its sole anchoring mechanism, the patent seeks to protect the apparatus that enables the improved surgical method (’446 Patent, col. 2:23-34).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (’533 Patent, Claim 1; Compl. ¶29).
  • The essential elements of this system claim include:
    • A one-piece device configured for introduction into the stomach.
    • The device consists of a sizing tube made of a flexible, non-expandable material.
    • The tube has a sidewall with a portion configured to extend the length of and bend into a curved shape to engage the stomach's lesser curvature.
    • The sidewall includes a plurality of apertures in an array extending about its periphery.
    • The device is configured to be coupled to a suction source, with the "controlled suction... serving as the sole means of holding said one-piece device in place."
  • The complaint does not explicitly reserve the right to assert dependent claims.

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

  • Technology Synopsis: This patent claims a system that explicitly includes a "suction controller" in addition to the non-expandable sizing instrument. The claims specify quantitative force ranges, stating the controller is configured to apply suction that results in a total anchoring force of 0.05 to 200 pounds and a suction force per unit length of 0.02 to 21 pounds per inch (’446 Patent, Claim 1).
  • Asserted Claims: Claim 1 (Compl. ¶37).
  • Accused Features: The complaint alleges the Siren SGT device includes a suction controller and operates within the claimed force ranges, pointing to the device's substantial equivalence to Plaintiff's ViSiGi® 3D device as evidence (Compl. ¶37, claim chart).

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

  • Technology Synopsis: This patent claims a system comprising a sizing tube with specific structural details. It describes a flexible, non-expandable sidewall that is "always able to bend into said curved shape to conform with the lesser curvature" and has an array of apertures extending about its "entire periphery," with suction serving as the "sole means of holding said sizing tube in place" (’937 Patent, Claim 1).
  • Asserted Claims: Claim 1 (Compl. ¶44).
  • Accused Features: The complaint alleges the Siren SGT device is a flexible, non-expandable tube with a sidewall and peripheral apertures that is held in place solely by suction, thereby meeting the claim limitations (Compl. ¶44, claim chart).

U.S. Patent No. 11,511,030 - "Gastric Sizing Systems Including Instruments and Methods of Bariatric Surgery"

  • Technology Synopsis: This patent claims a "one-piece, unitary device" with a cylindrical sidewall defining a "single longitudinally extending passageway" that is "empty." It claims a configuration where a "first portion" of the tube's exterior periphery extends along the lesser curvature, while a "second portion" extends towards the greater curvature, allowing suction to anchor the tube and produce a delineation line along that second portion (’030 Patent, Claim 1).
  • Asserted Claims: Claim 1 (Compl. ¶51).
  • Accused Features: The complaint alleges the Siren SGT is a one-piece device with an empty passageway and that its first and second peripheral portions engage the stomach curvatures as claimed, using an annotated product photograph to illustrate these features (Compl. ¶51, claim chart, p. 21).

U.S. Patent No. 12,303,415 - "Systems and Methods for Performing Bariatric Surgery"

  • Technology Synopsis: This patent claims a method of sizing a patient's stomach. It specifies using an instrument with a "circular outer surface being entirely continuous along an entire length of said sizing tube between said apertures." The method involves applying suction to pull the lesser curvature into engagement with the tube "without any portion of said instrument being interposed" between the tube's outer surface and the stomach interior (’415 Patent, Claim 1).
  • Asserted Claims: Claim 1 (Compl. ¶58).
  • Accused Features: The complaint alleges that using the Siren SGT device, which has a continuous circular outer surface, involves performing the claimed steps of applying suction without any interposed element (Compl. ¶58, claim chart).

III. The Accused Instrumentality

Product Identification

  • The Siren SGT Orogastric Tubes and the ZZIREN SGT Orogastric Tubes (collectively, the "Accused Instrumentality") (Compl. ¶14). The complaint alleges the ZZIREN device is the same as the Siren SGT for all material purposes (Compl. ¶21).

Functionality and Market Context

  • The Accused Instrumentality is described as an elongate, non-expandable insertion tube with a hollow interior and multiple side holes (apertures) near its distal end (Compl. ¶21, claim chart). It is designed to be connected to a vacuum source to apply suction (Compl. ¶21, claim chart). The complaint reproduces a figure from a patent showing the placement of such a tube along the lesser curvature of a patient's stomach (Compl. p. 6, Fig. 4).
  • The complaint alleges the Accused Instrumentality is intended "for use in gastric and bariatric surgical procedures... to assist in gastric sleeve formation by decompressing the stomach and serving as a sizing guide" (Compl. ¶21, claim chart). The complaint alleges that Defendant gained market entry via FDA 510(k) approval based on a "Substantial Equivalence Comparison" to Plaintiff's ViSiGi® 3D device, which is covered by the patents-in-suit (Compl. ¶17).

IV. Analysis of Infringement Allegations

'368 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of sizing the stomach of a patient for a bariatric procedure... The accused Siren SGT device is indicated for use in gastric and bariatric surgical procedures and to assist in gastric sleeve formation by serving as a sizing guide. ¶21 col. 1:33-42
providing a non-expandable instrument for introduction into the stomach of the patient... The accused device includes an elongate insertion tube formed of a flexible material that is not expandable. ¶21 col. 10:46-49
said instrument comprising a sizing tube... having a plurality of apertures disposed around the periphery of said sizing tube... The insertion tube acts as a sizing tube and has multiple side holes (apertures) disposed about its periphery near the distal end. ¶21 col. 7:1-5
introducing said sizing tube into the stomach of the patient... so that said elongated tubular member extends along the majority of the lesser curvature of the patient's stomach... The accused device is used for sleeve gastrectomy, where the insertion tube is extended along and engages the lesser curvature of the patient's stomach. The complaint includes a figure illustrating this placement (p. 6, Fig. 4). ¶21 col. 10:17-25
applying controlled suction... to anchor said sizing tube in place thereat... The accused device is connected to a suction source, and its instructions allegedly direct applying suction to anchor the tube. ¶21 col. 10:49-56
without the use of any expandable member to hold said sizing tube in place and to produce a suction-created visually perceptible delineation line... No expandable member is allegedly used, and suction applied to the accused device is alleged to produce a visually perceptible delineation line on the exterior of the stomach. The complaint includes a figure from the patent showing this delineation line (p. 7, Fig. 5). ¶21 col. 10:55-62
visualizing said suction-created visually perceptible delineation line with a laparoscope from outside of the patient's stomach... The accused device is used in laparoscopic surgery where the delineation line is visualized from outside the stomach. ¶21 col. 10:60-62

Identified Points of Contention:

  • Scope Questions: A central question may be the scope of "visually perceptible delineation line." The dispute could focus on how distinct or continuous this "line" must be to meet the claim limitation and whether the use of Defendant's device necessarily creates such a line.
  • Technical Questions: A factual question will be whether using the Accused Instrumentality, as instructed, results in the performance of every step of the claimed method. For instance, what evidence demonstrates that suction pulls both the stomach portions facing the tube and those facing away from the tube into engagement as specified in the "applying controlled suction" element?

'533 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A system for sizing a patient's stomach... said system comprising: a one-piece device configured for introduction through the esophagus... The accused device is a one-piece insertion tube used as a sizing guide and is introduced through the esophagus. ¶29 col. 2:10-15
an elongated unitary tubular member having... a sidewall... formed of a flexible non-expandable material, whereupon said portion of said sidewall is always able to bend into said curved shape... The accused device is an elongate tube made of a flexible, non-expandable material that is able to bend into a curved shape to conform with the stomach's lesser curvature. ¶29 col. 2:15-18
said sidewall including a plurality of apertures extending through said sidewall... The accused device includes a plurality of side holes (apertures) extending through its sidewall. ¶29 col. 2:18-23
said one-piece device being configured to be coupled to a source of suction... The accused device is configured to be coupled to a vacuum source to apply controlled suction to the patient's stomach. ¶29 col. 2:23-32
whereupon... said controlled suction as applied by said array serving as the sole means of holding said one-piece device in place in said curved shape... The suction applied through the side holes is alleged to be the sole means of holding the insertion tube in place. ¶29 col. 2:32-34

Identified Points of Contention:

  • Scope Questions: The term "sole means" may be a significant point of contention. The analysis may question whether suction is the only force holding the device in place, or if other forces (e.g., gravity, friction, the natural anatomy of the esophagus and stomach) also contribute, potentially placing the device outside the scope of the claim.
  • Technical Questions: A factual question may be whether the Accused Instrumentality is a "unitary" member as claimed. Evidence regarding its construction and whether it comprises multiple, separately formed components joined together could be relevant to this limitation.

V. Key Claim Terms for Construction

  • The Term: "visually perceptible delineation line" (’368 Patent, Claim 1)
  • Context and Importance: This term is the result of the claimed method and the primary feature that allegedly distinguishes it from prior art guides. The existence and nature of this "line" are central to the infringement allegation. Practitioners may focus on this term because its construction will determine whether the visual effect produced by the accused device meets the standard required by the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the line as a "visual indication" and a "guide," which may suggest that any observable boundary created by the suction would suffice, even if it is not perfectly sharp or continuous (’446 Patent, col. 1:65 - col. 2:2).
    • Evidence for a Narrower Interpretation: The specification also refers to a "clear line of delineation or demarcation" (’446 Patent, col. 10:57-58). Figure 5, reproduced in the complaint, depicts the line (12) as a distinct and sharp boundary, which could support an argument that a less-defined or intermittent visual effect would not infringe (Compl. p. 7, Fig. 5).
  • The Term: "sole means of holding" (’533 Patent, Claim 1)
  • Context and Importance: This limitation defines how the patented system is anchored within the stomach. Its interpretation is critical because if any other "means" contributes to holding the device in place, infringement may be avoided. Practitioners may focus on this term as it presents a potential non-infringement argument based on the contribution of other physical forces.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's abstract states that suction brings stomach portions into engagement with the tube "to provide a visually perceptible delineation line," and the system is designed to "hold the sizing tube in place when the controlled suction is applied," suggesting suction is the active, intended means for anchoring (’446 Patent, Abstract; col. 2:32-34). This may support an interpretation that "sole means" refers to the only applied or active force, as opposed to passive forces like gravity.
    • Evidence for a Narrower Interpretation: The plain meaning of "sole" is "one and only." A defendant may argue that if passive forces such as gravity, friction with the stomach wall, or the physical constraint of the esophagus contribute in any way to "holding" the device, then suction is not the "sole means," and the claim is not met.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all six patents. Inducement is based on allegations that Defendant, with knowledge of the patents, provides instructions and otherwise encourages end-users (surgeons) to use the Accused Instrumentality in an infringing manner (Compl. ¶¶ 23, 31, 38, 46, 52, 59). Contributory infringement is based on the allegation that the Accused Instrumentality has no substantial non-infringing use other than as a method for sizing for a bariatric procedure (Compl. ¶¶ 24, 32, 39, 45, 53, 60).
  • Willful Infringement: Willfulness is alleged for all six patents. The complaint bases this on alleged pre-suit knowledge, asserting that Defendant was aware of the ’368 and ’533 patents at least as early as December 24, 2018, from an IDS filed by its president's attorney, and again on December 8, 2020, when the USPTO cited the ’368 patent against that same attorney's application (Compl. ¶¶ 15-16, 25).

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

  • A core issue will be one of claim scope and interpretation: how will the court construe the terms "visually perceptible delineation line" and "sole means of holding"? The former will define the required outcome of the asserted methods, while the latter will define a critical structural and functional limitation of the asserted systems. The outcomes of these constructions will likely be dispositive of infringement.
  • A key evidentiary question will be one of technical and functional operation: what evidence will be presented to demonstrate that the Accused Instrumentality, when used as instructed, creates the claimed "delineation line" and is held in place solely by suction? The Plaintiff's reliance on the FDA's "substantial equivalence" finding will be tested against a technical analysis of whether every limitation of the asserted claims is met.
  • A central question for damages will be willfulness: do the complaint's allegations of pre-suit knowledge, particularly the specific references to an IDS filing and a USPTO office action involving Defendant's president, rise to the level of "egregious" conduct required to support a finding of willful infringement and potential enhancement of damages?