DCT
1:23-cv-00260
ReShape Lifesciences Inc v. Allurion Tech Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: ReShape Lifesciences Inc. (Delaware)
- Defendant: Allurion Technologies, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP
- Case Identification: 1:23-cv-00260, D. Del., 03/09/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation and therefore resides in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Allurion Gastric Balloon system infringes a patent related to swallowable, catheter-inflated intragastric devices for weight loss.
- Technical Context: The technology lies in the field of non-surgical bariatric devices, specifically intragastric balloons designed to be swallowed by a patient, inflated in the stomach, and later passed naturally.
- Key Procedural History: Plaintiff ReShape Lifesciences acquired the patent-in-suit through a June 2021 merger with the original patent assignee, Obalon Therapeutics. The complaint alleges that Defendant Allurion was aware of the asserted patent family since at least July 2017, when it cited a related patent during its own patent prosecution. Plaintiff sent a notice letter detailing its infringement allegations to Defendant on October 5, 2022.
Case Timeline
| Date | Event |
|---|---|
| 2011-01-21 | ’520 Patent Priority Date |
| 2015 | Allurion begins manufacturing its system in the U.S. and receives CE approval in Europe |
| 2017-07-07 | Allurion allegedly becomes aware of patent family via IDS citation of a related patent |
| 2019-11-05 | ’520 Patent Issue Date |
| 2020-04-07 | Allurion submits Premarket Approval (PMA) Application to the FDA |
| 2021-06 | ReShape Lifesciences merges with Obalon Therapeutics, acquiring the ’520 Patent |
| 2022-10-05 | ReShape sends notice letter alleging infringement to Allurion |
| 2023-03-09 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,463,520 - "Intragastric Device"
- Patent Identification: U.S. Patent No. 10,463,520, "Intragastric Device", issued November 5, 2019.
The Invention Explained
- Problem Addressed: The patent addresses the technical challenges associated with existing intragastric devices for obesity treatment, including the need for complex endoscopic or surgical insertion procedures and the unreliability of some early self-inflating mechanisms ('520 Patent, col. 1:42-53; col. 3:20-33).
- The Patented Solution: The patent describes an intragastric device system designed to be swallowed by a patient inside a degradable capsule ('520 Patent, col. 3:36-41). Once in the stomach, a balloon component is inflated with a fluid via a thin, removable catheter, after which the catheter is detached ('520 Patent, col. 14:5-24). The system incorporates specific valve and deflation components intended to provide more controlled deployment, operation, and eventual excretion ('520 Patent, col. 3:41-51).
- Technical Importance: The invention aims to provide a non-invasive, non-surgical weight-loss solution that offers greater control and reliability over the device's lifecycle compared to prior art alternatives ('520 Patent, col. 3:36-51).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claim 18 ('520 Patent, col. 50:35-51:45; Compl. ¶39).
- The essential elements of independent claim 1 are:
- a) a capsule configured to be swallowable and degrade in a gastric environment;
- b) a volume-occupying component (e.g., a balloon) within the capsule, comprising:
- i) a composite wall;
- ii) a self-sealing valve system with a septum; and
- iii) a deflation component that includes an erodible portion, a moisture absorbing expandable portion, and an inlet port;
- c) a catheter coupled to the valve system, comprising:
- i) a lumen for filling the volume-occupying component with an inflation fluid.
III. The Accused Instrumentality
Product Identification
- The "Allurion Gastric Balloon system," also known as the "Elipse" (Compl. ¶1).
Functionality and Market Context
- The accused system is described as a "pill balloon capsule" that a patient swallows (Compl. ¶46). The complaint includes "Figure 1: Elipse™ Device," which depicts the capsule attached to a thin delivery catheter (Compl. p. 8). The capsule is made of a "degradable material" that encloses a deflated balloon (Compl. ¶46).
- Once the device is in the stomach, a healthcare professional uses the attached catheter to fill the balloon with fluid (Compl. ¶56). After inflation, the catheter is detached from a "self-sealing valve" on the balloon (Compl. ¶52). The complaint provides "Figure 2: Elipse™ Balloon," which shows the inflated balloon and identifies a "Fill Valve" and a "Release Valve" (Compl. p. 8).
- The system is designed to automatically deflate after approximately 16 weeks when a "resorbable material inside the balloon degrades," allowing a "release valve" to open and the balloon to empty and pass naturally from the body (Compl. ¶¶46, 54).
- The complaint alleges significant commercial activity, citing revenues growing from $20 million in 2020 to $64 million in 2022 (Compl. ¶31).
IV. Analysis of Infringement Allegations
U.S. Patent No. 10,463,520 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) a capsule configured to be swallowable by normal peristalsis and to degrade in a gastric environment; | The Allurion system is a "pill balloon capsule, which is swallowed" and is composed of a "degradable material." | ¶46 | col. 12:7-10 |
| b) a volume-occupying component compacted and contained within the capsule... i) a composite wall... | A deflated gastric balloon made from a "polyurethane" thin film is enclosed within the capsule. | ¶¶46, 50 | col. 31:1-10 |
| ii) a self-sealing valve system including a septum | The system includes a "Fill Valve" described as a "self-sealing valve" that "Seals shut after Delivery Catheter is pulled out." | ¶52 | col. 21:11-15 |
| iii) a deflation component including an erodible portion, a moisture absorbing expandable portion and an inlet port in fluid communication with the interior cavity; | The system includes a "Release Valve" that opens after a "resorbable material inside the balloon degrades," allowing the balloon to empty. | ¶54 | col. 43:30-43 |
| c) a catheter coupled to the valve system... i) a lumen... configured for filling the volume-occupying component... with an inflation fluid. | The balloon is attached to a "very thin catheter" with a lumen through which it is filled with fluid, such as water. | ¶¶56, 52 | col. 14:5-24 |
Identified Points of Contention
- Technical Question: A central point of dispute may concern the "deflation component" of claim 1(b)(iii). The claim recites a specific three-part structure: "an erodible portion, a moisture absorbing expandable portion and an inlet port." The complaint alleges the accused product has a "Release Valve" that works via a degrading "resorbable material" (Compl. ¶54). This raises the question of whether the accused product's deflation mechanism contains all three distinct structural elements required by the claim language, or if there is a technical mismatch. The evidence cited in the complaint consists of public-facing marketing materials and scientific articles, which may not provide the level of technical detail needed to resolve this question.
V. Key Claim Terms for Construction
- The Term: "deflation component including an erodible portion, a moisture absorbing expandable portion and an inlet port"
- Context and Importance: Practitioners may focus on this term because it describes a complex, multi-element feature that appears central to the patent's novelty. The outcome of the infringement analysis for the asserted independent claim will likely depend on how this term is construed and whether the accused product's "Release Valve" falls within that construction.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party seeking a broader construction might point to the specification's disclosure of numerous different deflation mechanisms ('520 Patent, e.g., FIGS. 19A-D, 22A-B, 26A-C) to argue that the inventors conceived of various ways to achieve timed deflation and did not intend to limit the invention to a single structure.
- Evidence for a Narrower Interpretation: A party seeking a narrower construction may argue that the claim's explicit recitation of three distinct sub-components is highly limiting. The specification provides specific support for this exact combination of elements ('520 Patent, FIG. 21C; col. 43:30-43), which could be used to argue that the claim scope is tied to embodiments containing all three named parts and does not cover simpler deflation mechanisms that may be missing one or more of them.
VI. Other Allegations
Willful Infringement
- The complaint alleges willful infringement based on both pre- and post-suit-knowledge (Compl. ¶65). It alleges pre-suit knowledge dating to at least July 7, 2017, based on Defendant's citation of a related patent in an Information Disclosure Statement (IDS) filed during its own patent prosecution (Compl. ¶64). The complaint also alleges knowledge based on a detailed notice letter sent by Plaintiff on October 5, 2022, which explicitly outlined the basis for the infringement allegations (Compl. ¶63).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical and structural correspondence: does the accused Allurion system's "Release Valve" embody the specific, three-part "deflation component" recited in Claim 1—namely, a structure containing an "erodible portion," a "moisture absorbing expandable portion," and an "inlet port"? The resolution will depend on both claim construction and the specific technical details of the accused product.
- A key evidentiary question will be one of proof: does the evidence cited in the complaint—primarily marketing materials and third-party publications—provide a sufficient basis to establish that the accused product's internal mechanism performs the exact function and possesses the specific structure required by the claim, or will discovery reveal a fundamental mismatch in technical operation?