DCT

1:25-cv-01193

Medtimo Inc v. Allurion Tech Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-01193, D. Del., 09/25/2025
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and thus resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Allurion Gastric Balloon system infringes three patents related to swallowable, intragastric devices for weight loss.
  • Technical Context: The technology concerns medical devices, specifically gastric balloons, which are non-surgically placed in a patient's stomach and inflated to occupy volume, thereby creating a feeling of satiety to aid in weight loss.
  • Key Procedural History: The complaint alleges a prolonged history between the parties, including that Defendant cited a related patent from the same family in an Information Disclosure Statement (IDS) during its own patent prosecution in 2017. Plaintiff sent notice letters regarding the ’520 Patent in 2022 and the ’482 and ’934 Patents upon their issuance in 2023 and 2024, respectively. Plaintiff’s predecessor filed and voluntarily dismissed a prior lawsuit on the ’520 Patent in 2023. Notably, Defendant filed an ex parte reexamination request against the ’482 Patent in May 2024, which resulted in the U.S. Patent and Trademark Office confirming the patentability of all claims in November 2024.

Case Timeline

Date Event
2011-01-21 Patent Priority Date (’520, ’482, ’934 Patents)
2015-01-01 Allurion begins manufacturing its system in the U.S. for export
2016-01-01 Allurion begins selling the Allurion Balloon in Europe
2017-07-07 Allurion allegedly cites a related Medtimo patent in an IDS
2019-11-05 U.S. Patent No. 10,463,520 Issues
2020-04-07 Allurion submits PMA Application to the FDA for its system
2022-10-05 Medtimo sends notice letter to Allurion regarding the ’520 Patent
2023-03-01 Medtimo's predecessor files suit against Allurion on the ’520 Patent
2023-05-01 Medtimo's predecessor dismisses prior suit without prejudice
2023-10-10 U.S. Patent No. 11,779,482 Issues
2023-10-17 Medtimo sends notice letter to Allurion regarding the ’482 Patent
2024-05-07 U.S. Patent No. 11,974,934 Issues
2024-05-23 Allurion files ex parte reexamination request for the ’482 Patent
2024-06-11 USPTO grants ex parte reexamination request for the ’482 Patent
2024-11-26 USPTO confirms patentability of all claims of the ’482 Patent
2024-12-23 USPTO issues ex parte reexamination certificate for the ’482 Patent
2025-09-19 Medtimo sends notice letter to Allurion regarding the ’934 Patent
2025-09-25 Complaint Filing Date

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

U.S. Patent No. 10,463,520 - "Intragastric Device"

The Invention Explained

  • Problem Addressed: The patent’s background section describes shortcomings of prior art intragastric devices used for obesity treatment, noting that many require complex or invasive surgical or endoscopic procedures for placement, while others that are swallowable rely on unreliable inflation mechanisms, such as thermal triggering (’520 Patent, col. 2:56–4:40).
  • The Patented Solution: The patent describes a “free-floating, intragastric, volume-occupying device” that a patient can swallow (’520 Patent, col. 4:41-49). The device is compacted within a capsule for swallowing and is attached to a thin catheter that remains outside the patient's mouth. Once the capsule is in the stomach, a fluid is used to inflate the balloon via the catheter, which is then detached, leaving the inflated balloon in the stomach (’520 Patent, col. 13:3-23). The invention focuses on the valve system that allows for reliable inflation and catheter detachment.
  • Technical Importance: This approach aims to provide a non-surgical, non-endoscopic, and more reliable method for deploying a gastric balloon, potentially reducing procedural complexity, cost, and patient discomfort compared to prior art methods (’520 Patent, col. 13:3-13).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert others (Compl. ¶53).
  • Essential elements of independent claim 1 include:
    • A capsule configured to be swallowable
    • A balloon compacted within the capsule
    • A fill valve for inflating the balloon
    • A release valve, separate from the fill valve, for deflating the balloon
    • A catheter coupled to the fill valve to deliver an inflation liquid
    • The fill valve is a self-sealing valve that seals after the catheter is detached
    • The release valve has a degradable portion configured to degrade in the balloon’s internal environment

U.S. Patent No. 11,779,482 - "Intragastric Device"

The Invention Explained

  • Problem Addressed: As a continuation in the same patent family, the ’482 Patent addresses the same technical problems as the ’520 Patent, namely the procedural difficulty and unreliability of prior art intragastric devices (’482 Patent, col. 2:56–4:40).
  • The Patented Solution: The ’482 Patent also discloses a swallowable, catheter-inflated gastric balloon system (’482 Patent, col. 4:41-49). The claimed invention emphasizes a specific mechanism for eventual, automatic deflation. It claims a system where the balloon contains both a fill valve for inflation and a separate release valve with a degradable portion that degrades over time when exposed to the saline liquid inside the balloon, causing the balloon to deflate and pass through the digestive system (’482 Patent, Claim 1).
  • Technical Importance: The invention provides a mechanism for a gastric balloon to deflate automatically after a predetermined period (e.g., several months), eliminating the need for a second medical procedure to retrieve the device (’482 Patent, col. 5:47-64).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert others (Compl. ¶66).
  • Essential elements of independent claim 1 include:
    • A capsule configured to be swallowable by normal peristalsis
    • A balloon compacted within the capsule, having an interior cavity
    • A fill valve and a separate release valve
    • A catheter to deliver saline liquid to inflate the balloon
    • The fill valve is a self-sealing valve
    • The release valve has a degradable portion configured to degrade in the internal environment of the balloon’s interior cavity in response to the saline liquid being in contact with it, thereby opening the valve

U.S. Patent No. 11,974,934 - "Intragastric Device"

  • Technology Synopsis: This patent is also part of the same family and relates to a swallowable intragastric balloon system designed for non-invasive obesity treatment. The claims focus on the structure of the release valve, which comprises a "seam where at least two portions of the balloon are joined together," with a degradable portion of that seam designed to degrade in the balloon's internal environment to cause deflation (’934 Patent, Claim 1). This provides a specific structural implementation for the timed-release deflation mechanism.
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶77).
  • Accused Features: The complaint alleges that the Allurion Gastric Balloon system infringes (Compl. ¶75).

III. The Accused Instrumentality

Product Identification

  • The Allurion Gastric Balloon system, previously known as the "Elipse" (Compl. ¶1).

Functionality and Market Context

  • The complaint describes the accused product as a system used to treat obesity and metabolic disease that competes with Plaintiff's products (Compl. ¶23).
  • Allurion has allegedly manufactured the system in the United States for export since 2015 and has sought FDA Premarket Approval for sales within the United States since April 2020 (Compl. ¶24, ¶26).
  • The complaint alleges significant revenue from sales of the Allurion Balloon outside the United States, citing revenues of $20 million, $38 million, and $64 million in 2020, 2021, and 2022, respectively (Compl. ¶27).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint references claim chart exhibits (Exhibits J, K, and L) that were not provided with the filing (Compl. ¶50, ¶63, ¶76). The complaint's narrative infringement theory is conclusory, alleging that the Allurion system "meets each and every limitation of claim 1" of each Asserted Patent, either literally or under the doctrine of equivalents (Compl. ¶51, ¶64, ¶77). Without the claim charts, a detailed element-by-element analysis based on the complaint is not possible.

  • Identified Points of Contention:
    • Structural Questions: A central point of contention may be whether the Allurion system contains two distinct and separate valve structures corresponding to the claimed "fill valve" and "release valve" as required by independent claim 1 of the ’520 and ’482 Patents. Practitioners may observe that integrated valve systems performing multiple functions are common in medical devices, and the court may need to determine if the accused product's architecture maps onto the claims' requirement for separate valves.
    • Technical Questions: For the ’482 and ’934 Patents, the infringement analysis will likely focus on the specific mechanism of deflation. A key question for the court will be whether the deflation mechanism of the Allurion system is triggered by a "degradable portion" that degrades specifically "in an internal environment of the interior cavity of the balloon" and "in response to the saline liquid," as claimed in the ’482 Patent. Evidence regarding the materials used in the Allurion system and the chemical process of its deflation mechanism will be critical.

V. Key Claim Terms for Construction

  • The Term: "release valve" (appearing in claim 1 of the ’520, ’482, and ’934 Patents)

  • Context and Importance: The claims of the ’520 and ’482 Patents explicitly require a "fill valve" and a "release valve," and state that they are "separate valves" (’482 Patent, Claim 1). The definition of "release valve" and the scope of "separate" will be critical. If the Allurion system uses a single, multi-functional valve port for both inflation and eventual deflation, the case may turn on whether that single structure can be interpreted as meeting the "separate valves" limitation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification does not appear to provide an explicit definition of "release valve" that would require a wholly distinct physical structure from the fill valve. A party might argue that if different components within a single housing perform the separate functions of filling and releasing at different times, they could be considered functionally separate valves.
    • Evidence for a Narrower Interpretation: The consistent use of separate terms ("fill valve" and "release valve") and the explicit limitation "wherein the fill valve and the release valve are separate valves" (’482 Patent, Claim 1) suggests a requirement for two structurally distinct components. The patent figures illustrate various deflation mechanisms that are physically separate from the inflation valve system, such as erodible plugs or seams located elsewhere on the balloon wall (’482 Patent, Figs. 19A-28D).

  • The Term: "degradable portion ... configured to degrade in an internal environment of the interior cavity of the balloon" (’482 Patent, Claim 1)

  • Context and Importance: This term is central to the non-obviousness of the claimed invention and its alleged infringement. Practitioners may focus on this term because it defines the trigger for the balloon's automatic deflation. The dispute may center on whether the degradation of the accused device's deflation mechanism is controlled solely by the internal environment (the inflation liquid) or if it relies on external factors from the gastric environment (e.g., acid, enzymes) permeating the balloon wall.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: A party could argue that "in response to the saline liquid" does not exclude the presence of other contributing factors. The term "internal environment" could be construed to include any substances that have permeated into the balloon's interior from the outside gastric environment over time.
    • Evidence for a Narrower Interpretation: The claim language recites degradation occurring "in an internal environment" and "in response to the saline liquid being in contact with the degradable portion." This language may support a narrower construction requiring the degradation chemistry to be primarily or exclusively driven by the inflation fluid itself, independent of external gastric factors. The specification describes numerous deflation mechanisms, such as an erodible core that dissolves upon exposure to moisture inside the balloon, which supports a focus on the internal environment as the trigger (’482 Patent, col. 43:44-44:20).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all three patents. It asserts that Allurion provides the Allurion system with the knowledge and intent that its customers and end-users will combine and use the components in an infringing manner. The complaint further alleges that the Allurion system is not a staple article of commerce and has no substantial non-infringing use (Compl. ¶53-55, ¶66-68, ¶79-81).
  • Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged knowledge of the Asserted Patents and their shared patent family. The basis for willfulness includes alleged pre-suit knowledge dating back to at least July 2017, when Allurion cited a parent patent in an IDS (Compl. ¶31-33). It further cites specific pre-suit notice letters sent for each of the Asserted Patents (Compl. ¶34, ¶40, ¶46) and Defendant's continued alleged infringement after a prior lawsuit was filed and after the USPTO confirmed the validity of the ’482 Patent claims in an ex parte reexamination initiated by Allurion itself (Compl. ¶37, ¶43-44).

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

  • A core issue will be one of structural correspondence: Does the Allurion system’s valve architecture, which facilitates both inflation and eventual deflation, embody the "separate" "fill valve" and "release valve" structures required by the asserted claims, or does it utilize an integrated, multi-function design that falls outside the literal scope of the claims?
  • A key evidentiary question will be one of causation and environment: What is the precise technical mechanism that triggers deflation in the Allurion system? The case may turn on factual evidence demonstrating whether this mechanism degrades solely "in response to" the internal saline fluid, as claimed in the ’482 Patent, or if it is substantially dependent on the permeation of external gastric fluids or other triggers.
  • A central legal question will concern damages and willfulness: Given the complaint’s detailed allegations of long-term knowledge, prior litigation, and particularly the outcome of the ex parte reexamination on the ’482 patent, a key focus will be on whether Defendant's alleged conduct rises to the level of willful infringement, which could expose it to enhanced damages.