DCT
8:18-cv-01265
Fulfillium Inc v. ReShape Medical LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Fulfillium, Inc. (Delaware)
- Defendant: ReShape Medical LLC (Delaware), SV Health Investors, LLC (Delaware), Intersect Partners, LLC (Nevada), and ReShape Lifesciences, Inc. (Delaware)
- Plaintiff’s Counsel: Devlin Law Firm LLC; Gardella Grace P.A.
- Case Identification: 8:18-cv-01265, C.D. Cal., 08/15/2018
- Venue Allegations: Plaintiff alleges venue is proper because Defendants conduct business, have committed acts of infringement, and have a regular and established place of business in the district.
- Core Dispute: Plaintiff alleges that Defendants’ dual intragastric balloon for obesity treatment infringes three patents and that the product was developed using misappropriated trade secrets confidentially disclosed by Plaintiff’s founder.
- Technical Context: The technology relates to bariatric medical devices, specifically multi-chamber intragastric balloons designed to be a safer, non-surgical alternative for weight loss.
- Key Procedural History: The complaint details a history of confidential disclosures in 2005 between Plaintiff’s founder, Dr. Chen, and venture capital firms that were predecessors to the Defendants. Plaintiff alleges these firms used the disclosed technology and trade secrets to form a competing company (ReShape Medical) and develop the accused product. The complaint also alleges that ReShape Medical cited Dr. Chen’s patents and patent applications as relevant prior art during its own patent prosecution, and that it received explicit notice of the ’367 patent prior to the suit.
Case Timeline
| Date | Event |
|---|---|
| 2004-05-03 | Plaintiff alleges its founder, Dr. Chen, filed his first provisional patent application |
| 2004-11-19 | Earliest priority date for the patents-in-suit |
| 2005-01-25 | Dr. Chen's initial confidential discussion with SV Life Sciences |
| 2005-02-10 | Dr. Chen's confidential presentation to SV Life Sciences team |
| 2005-03-04 | Dr. Chen's confidential presentation to Sprout Partners |
| 2005-05-16 | Dr. Chen's meeting with SV Life Sciences venture partner George Wallace |
| 2005-Summer | Abdominis, Inc. (predecessor to ReShape Medical) was formed |
| 2012-XX-XX | ReShape Medical, Inc. started pivotal clinical trials |
| 2014-XX-XX | ReShape Medical, Inc. applied for FDA approval |
| 2015-07-28 | FDA granted Pre-Marketing Approval to the ReShape Duo™ device |
| 2016-09-20 | U.S. Patent No. 9,445,930 issued |
| 2016-10-04 | U.S. Patent No. 9,456,915 issued |
| 2017-10-02 | EnteroMedics, Inc. acquired ReShape Medical, Inc. |
| 2017-10-23 | EnteroMedics, Inc. changed its name to ReShape Lifesciences Inc. |
| 2017-11-07 | U.S. Patent No. 9,808,367 issued |
| 2017-11-14 | ReShape allegedly received explicit notice of the ’367 patent via letter |
| 2018-08-15 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,456,915 - Methods, Devices, and Systems for Obesity Treatment
The Invention Explained
- Problem Addressed: The patent’s background describes the risks associated with prior art single-chamber gastric balloons, which, upon accidental deflation, could pass through and obstruct the pyloric valve or intestines, creating a medical emergency (Compl. ¶22; ’915 Patent, col. 2:38-48).
- The Patented Solution: The invention is a gastric balloon structure with at least two isolated, non-concentric inflatable chambers. This design provides a failsafe: if one chamber deflates, the remaining inflated chamber(s) ensure the device's overall volume is large enough to prevent it from migrating and causing an obstruction ('915 Patent, cl. 1). The structure is connected by a flexible central spine, allowing it to conform to the natural "kidney shape" of the gastric cavity, which is intended to improve patient tolerability (’915 Patent, cl. 1; col. 10:9-12).
- Technical Importance: The multi-chamber approach was designed to significantly enhance the safety profile of intragastric balloons by mitigating the critical failure mode of migration following a leak (Compl. ¶22).
Key Claims at a Glance
- The complaint asserts independent claims 1, 12, and 19 (Compl. ¶61). Representative device claim 1 includes the following essential elements:
- A gastric balloon structure comprising at least two isolated non-concentric inflatable chambers.
- The deflation of any single chamber leaves the inflated volume of the remaining chambers unaffected.
- A valve system for introducing and retaining fluid in the chambers.
- A flexible central spine spanning a gap between and fixedly attached to a first and second chamber.
- The structure, when inflated, assumes a curved shape conforming to the natural three-dimensional kidney shape of the gastric cavity.
- The complaint reserves the right to assert dependent claims 2 and 4-11, 13-18, and 20-27 (Compl. ¶61).
U.S. Patent No. 9,445,930 - Methods, Devices, and Systems for Obesity Treatment
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the ’915 Patent: the risk of intestinal obstruction if a single-compartment gastric balloon deflates and migrates past the pylorus (’930 Patent, col. 2:38-48).
- The Patented Solution: This patent also discloses an obesity treatment device with a plurality of "adjacent, spaced apart inflatable space-filling compartments" designed to maintain their inflated volume during treatment (’930 Patent, cl. 1). A key feature is a valve system for each compartment that includes at least two valves in series, providing redundant protection against leakage. The overall structure is also designed to conform to the stomach's natural curvature to enhance tolerability (’930 Patent, Abstract; cl. 1).
- Technical Importance: This invention provides a different approach to enhancing safety, focusing on a redundant valve system to prevent deflation in the first place, in addition to the multi-compartment design that mitigates the consequences of a leak.
Key Claims at a Glance
- The complaint asserts independent claims 1, 12, and 19 (Compl. ¶137). Representative device claim 1 includes the following essential elements:
- An obesity treatment device comprising a plurality of adjacent, spaced apart inflatable space-filling compartments.
- Each compartment has a respective inflated state volume that is maintained during treatment.
- A valve system for introducing and retaining fluid.
- The valve system includes a respective valve structure for each compartment with at least a first valve in series with a second valve.
- The device forms a curved shape conforming to the natural kidney shape of the stomach.
- The complaint reserves the right to assert dependent claims 2, 4-11, 13-18, 21-27, and 30 (Compl. ¶137).
U.S. Patent No. 9,808,367 - Methods, Devices, and Systems for Obesity Treatment
Technology Synopsis
This patent describes a "free floating, untethered gastric balloon structure" with at least two isolated, non-concentric chambers designed to prevent migration if one chamber deflates (Compl. ¶212). The invention includes a "flexible member" connecting the chambers that also carries inflation tubes, which allows the entire device to float freely within the stomach without being connected to any catheter, lumen, or tether after deployment (Compl. ¶214).
Asserted Claims
Independent claims 1 and 16 are asserted (Compl. ¶211).
Accused Features
The complaint alleges that the ReShape Duo Balloon is a free-floating, dual-chamber device connected by a flexible member that is untethered after deployment, thereby infringing the claims of the ’367 Patent (Compl. ¶¶212, 214).
III. The Accused Instrumentality
Product Identification
The ReShape Duo Balloon, also referred to as the "ReShape Balloon" (Compl. ¶¶60-61).
Functionality and Market Context
The ReShape Duo Balloon is described as a "temporary implant designed to facilitate weight loss by occupying space in the stomach" (Compl. ¶62). It consists of two connected, independently sealed balloons that are placed into the stomach endoscopically and then filled with saline (Compl. ¶¶62, 83). The complaint alleges the device is designed to "mimic the natural curvature of the stomach" to improve patient tolerability (Compl. ¶69). Its dual-balloon design is marketed as a safety feature to "minimize risk of migration or obstruction" in the event of leakage from a single balloon (Compl. ¶62).
IV. Analysis of Infringement Allegations
'915 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a gastric balloon structure...comprising: at least two isolated non-concentric inflatable chambers, wherein each chamber...has a respective inflated state volume such that deflation of any single chamber...leaves the inflated state volume of the remaining chambers...unaffected | The ReShape Duo Balloon consists of two "independently sealed" balloons, where each "inflates and deflates independently." | ¶62 | col. 10:9-12 |
| a valve system for introducing a fluid into the...chambers and for retaining, upon inflation, the fluid | The chambers of the ReShape balloons are filled after being positioned in the stomach and use a "Valve Sealant" to seal the device valves and prevent leakage. | ¶63 | col. 12:15-18 |
| a flexible central spine spanning a gap between and fixedly attached to both a first chamber...and a second chamber... | The complaint alleges the two balloons are connected by a flexible central spine element, referencing an illustrative video on ReShape's website. A frame from this video shows two spheres connected by a central structure. (Compl. p. 19). | ¶64 | col. 10:12-19 |
| wherein the gastric balloon structure, in its inflated state, assumes a curved shape conforming to a natural three-dimensional kidney shape of the gastric cavity... | The ReShape website is quoted as stating the device "mimics 'the natural curvature of the stomach'" and is "designed to conform to the patient's anatomy." A diagram shows the device conforming to the stomach's shape. (Compl. p. 18). | ¶64 | col. 10:19-24 |
Identified Points of Contention
- Scope Questions: A primary point of contention may be whether the connecting element of the ReShape Duo Balloon meets the claim limitation of a "flexible central spine." The defense may argue its connector has a different structure or function that falls outside the patent's definition of a "spine."
- Technical Questions: The analysis will question what evidence demonstrates that the accused device's shape "conforms" to the "natural three-dimensional kidney shape of the gastric cavity" as required by the claim, beyond marketing statements.
'930 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| An obesity treatment device...comprising: a plurality of adjacent, spaced apart inflatable space-filling compartments, wherein each compartment...has a respective inflated state volume that is maintained during treatment of the patient | The accused product is the ReShape Dual Balloon, a temporary implant with two balloon compartments whose inflated volume is maintained during use. | ¶138 | col. 9:8-14 |
| a valve system for introducing a fluid into each compartment...and for retaining...fluid | The chambers of the ReShape balloons are filled after placement and use a "Valve Sealant" to seal the valves and prevent leakage. | ¶139 | col. 24:1-5 |
| wherein each respective valve structure includes at least a first valve in series with a second valve | The complaint alleges the ReShape Balloon includes two valves in series, citing Figure 7 from ReShape’s own U.S. Patent No. 8,142,469 as evidence. This figure shows two valve structures labeled 206A and 96A arranged sequentially. (Compl. p. 50). | ¶140 | col. 12:15-18 |
| wherein the obesity treatment device is to form...to a curved shape conforming to a natural three-dimensional kidney shape of the stomach... | The complaint quotes ReShape's website, which states the device "mimics 'the natural curvature of the stomach'" and is designed to conform to anatomy. A provided image illustrates this conformance. (Compl. p. 51). | ¶141 | col. 9:15-19 |
Identified Points of Contention
- Technical Questions: A central evidentiary question will be whether the commercially sold ReShape Duo Balloon actually incorporates the "valve in series with a second valve" structure. The complaint's reliance on a figure from a ReShape patent, rather than direct evidence from the product itself, suggests that the actual construction of the accused valve system will be a key factual dispute.
V. Key Claim Terms for Construction
The Term: "flexible central spine" (’915 Patent, cl. 1)
- Context and Importance: This term is a core structural element defining the connection between the two inflatable chambers. The infringement analysis for the ’915 patent may hinge on whether the accused device's connector falls within the scope of this term. Practitioners may focus on this term because the physical nature of the connection is a likely point of non-infringement argument.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification may describe the purpose of the spine as providing a flexible connection that allows conformance to the stomach's shape, potentially supporting a construction that covers any flexible member serving that function (See, e.g., ’915 Patent, col. 10:12-24).
- Evidence for a Narrower Interpretation: The figures and corresponding descriptions may depict a specific structure with defined characteristics (e.g., a particular material, cross-section, or method of attachment) that could be argued to limit the scope of the term "spine" to the disclosed embodiments (See, e.g., ’915 Patent, Fig. 15F, element 1550).
The Term: "valve in series with a second valve" (’930 Patent, cl. 1)
- Context and Importance: This limitation requires a specific, redundant valve architecture. Infringement of the '930 patent's primary independent claim depends on the accused device possessing this feature for each compartment. The dispute will likely focus on the structural and functional definition of "in series."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent may describe the purpose of the series valves as providing redundant sealing, suggesting a functional definition where any two sequential valve mechanisms that fluid must pass through would meet the limitation, regardless of their physical integration (’930 Patent, col. 12:15-18).
- Evidence for a Narrower Interpretation: The term "in series" has a well-understood meaning in engineering, and figures in related patents cited by the complaint suggest a specific sequential arrangement of distinct valve components (Compl. ¶140, citing U.S. Patent 8,142,469). The defense may argue for a narrow structural definition based on such embodiments.
VI. Other Allegations
Indirect Infringement
The complaint alleges Defendants induce infringement by providing instruction manuals, training, and services that actively encourage and instruct medical professionals and end-users to use the ReShape Duo Balloon in a manner that directly infringes the asserted patents (Compl. ¶¶125-126, 199-200, 247-248).
Willful Infringement
Willfulness is alleged based on both pre- and post-issuance knowledge. The complaint asserts that Defendants' predecessors knew of Dr. Chen’s technology through confidential disclosures in 2005 (Compl. ¶¶123, 202). It further alleges that ReShape Medical cited Dr. Chen’s patents and applications as relevant prior art during prosecution of its own patents, demonstrating knowledge of the technology area (Compl. ¶¶123, 202). For the ’367 patent specifically, the complaint alleges ReShape received explicit notice via a letter on November 14, 2017 (Compl. ¶250).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of claim construction and scope: can the term “flexible central spine,” as defined in the ’915 patent, be construed to read on the specific connecting member used in the ReShape Duo Balloon? Similarly, does the accused product’s valve mechanism meet the “valve in series with a second valve” limitation of the ’930 patent?
- A key evidentiary question will be the actual technical makeup of the accused product. The complaint’s reliance on a ReShape-owned patent to evidence the dual-valve structure, rather than analysis of the product itself, flags this as a critical area for discovery and a likely point of factual dispute.
- Beyond the patent claims, a central issue for the fact-finder will be the allegation of trade secret misappropriation. The case will likely turn on whether Plaintiff can prove that Defendants used confidential information from Dr. Chen’s 2005 disclosures to develop the ReShape Duo Balloon, an allegation which, if proven, could fundamentally shape the narrative and potential damages in the case.