DCT
4:22-cv-00359
Innovamed Health LLC v. ManaMed Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Innovamed Health LLC (Texas) and Precision Holdings USA Inc. (California)
- Defendant: ManaMed Inc. (Nevada)
- Plaintiff’s Counsel: Potter Minton, PC; Paul Hastings LLP
- Case Identification: 4:22-cv-00359, E.D. Tex., 04/29/2022
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Texas because Defendant maintains a regular and established physical place of business, specifically a distribution center with full-time personnel, within the district.
- Core Dispute: Plaintiff alleges that Defendant’s portable deep vein thrombosis compression products infringe two patents related to portable, self-contained intermittent pneumatic compression systems.
- Technical Context: The technology concerns battery-operated, tubeless compression devices worn on a patient's limb to prevent blood clots, aiming to improve patient mobility and safety compared to traditional tethered systems.
- Key Procedural History: The complaint alleges that Plaintiff previously licensed the patented technology to DJO, LLC, which sold a product named VenaPro®. It further alleges that Defendant’s principals were former distributors of this licensed product, which may be used to support allegations of pre-suit knowledge and willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2013-03-15 | Priority date for '475 and '704 Patents |
| ~2014-01-01 | Innovamed licenses technology to DJO |
| 2014-03-17 | '475 Patent application filed |
| 2014-10-09 | '475 Patent application published |
| 2015-02-06 | ManaMed incorporated |
| ~2016-01-01 | ManaMed launches PlasmaFlow product |
| 2018-07-26 | '704 Patent application filed |
| 2018-08-28 | '475 Patent issued |
| 2021-02-09 | '704 Patent issued |
| 2022-04-29 | Complaint filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,058,475 - "Portable Intermittent Pneumatic Compression System," issued August 28, 2018
The Invention Explained
- Problem Addressed: The patent describes conventional intermittent pneumatic compression systems as having numerous shortcomings. These include the use of tubing that presents a tripping hazard, a lack of true portability due to reliance on AC power, and the potential for patient discomfort from sweat and soreness caused by the wrap. Additionally, conventional systems may not accurately measure pressure in the most remote parts of the inflatable bladder (’475 Patent, col. 1:31-48).
- The Patented Solution: The invention is a self-contained, portable, battery-operated compression system where the pumping module is attached directly to a flexible wrap, eliminating external tubes (’475 Patent, col. 2:5-7). The system features an inflatable bladder divided into at least two sections by a flow-restricting "divider," which causes the sections to inflate progressively. A pressure sensor is specifically placed in a section remote from the inflation port to ensure accurate therapeutic pressure is achieved throughout the bladder (’475 Patent, col. 5:27-35; col. 6:2-9).
- Technical Importance: This integrated design sought to provide "true portability while improving patient discomfort, reducing fall risks, and providing desired therapeutic and prophylactic compression" for mobile patients (’475 Patent, Abstract).
Key Claims at a Glance
- The complaint asserts independent claim 16 (Compl. ¶32).
- Claim 16 requires, in part:
- An air pumping module with a power supply, control unit, and valve.
- A flexible inflatable wrap with a bladder, directly coupled to the air pumping module.
- The bladder has a first and second section separated by a "divider" creating a passageway.
- An inflation port is connected within the first section, and a pressure sensor is connected within the second section.
- The valve enables air to flow only from the inflation port to the bladder via a first connection line.
- The pressure sensor measures pressure via a second connection line to the second section, where this second line is "only used for measuring" the pressure.
- The complaint alleges infringement of "one or more claims," preserving the right to assert others (Compl. ¶31).
U.S. Patent No. 10,912,704 - "Portable Intermittent Pneumatic Compression System," issued February 9, 2021
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the '475 Patent, the '704 Patent addresses the same problems of conventional compression systems: cumbersome tubing, lack of portability, and patient discomfort (’704 Patent, col. 1:20-51).
- The Patented Solution: The '704 Patent also discloses a tubeless, portable compression device. It specifically claims an architecture where the air pumping module is "mounted on said inflatable bladder." A key feature is the separation of functions: a valve enables air to flow to the first section of the bladder through a first line to cause inflation, while air pressure is measured by a pressure sensor connected to the second section of the bladder via a second line that "does not provide air to inflate said inflatable bladder" (’704 Patent, Abstract; col. 10:55-11:21).
- Technical Importance: This integrated structure aims to create a fully self-contained medical device that improves patient compliance and mobility by eliminating external connections (’704 Patent, col. 2:58-62).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶55).
- Claim 1 requires, in part:
- An air pumping module with a control unit, valve, and a "first pressure port."
- A flexible wrap with a bladder having first and second sections connected by a passageway.
- An inflation port is coupled to the first section via a first line; a pressure sensor is coupled to the second section via a second line connected to the module's "first pressure port."
- The "first pressure port is the only pressure sensing port" on the module.
- The air pumping module is "mounted on said inflatable bladder."
- The valve enables inflation via the first line, while pressure is measured via the second line which "does not provide air to inflate."
- The complaint alleges infringement of "one or more claims," preserving the right to assert others (Compl. ¶54).
III. The Accused Instrumentality
Product Identification
- The complaint names the "PlasmaFlow" and "PlasmaFlight" products as the Accused Products (Compl. ¶25). The infringement allegations focus on the PlasmaFlow as the exemplary device (Compl. ¶33, ¶56).
Functionality and Market Context
- The Accused Products are alleged to be "portable deep vein thrombosis compression products" that function as portable intermittent pneumatic compression systems (Compl. ¶24, ¶34, ¶57).
- The complaint includes a visual depicting the PlasmaFlow and PlasmaFlight products as integrated units, each consisting of a leg wrap with a compact control module mounted on its exterior (Compl. p. 6).
- The complaint alleges these products directly compete with the VenaPro® product, which purportedly practices the patents-in-suit under a license from Plaintiff (Compl. ¶17, ¶21). It is also alleged that the PlasmaFlow is distributed by Medline Industries, Inc. under the name "Hemo-Force Mobile" (Compl. ¶23).
IV. Analysis of Infringement Allegations
’475 Patent Infringement Allegations
| Claim Element (from Independent Claim 16) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an air pumping module comprising a power supply, an electronic control unit, and a valve with an inflation port | The Accused Products are portable systems with an air pumping module containing these components. | ¶34 | col. 2:61-65 |
| a flexible inflatable wrap comprising an inflatable bladder... wherein said flexible inflatable wrap is directly coupled to said air pumping module | The Accused Products have a flexible inflatable wrap that is directly coupled to the air pumping module. | ¶36-37 | col. 2:5-7 |
| said inflatable bladder comprises a first section and a second section separated by a divider that provides a passageway from said first section to said second section | The Accused Products allegedly have an inflatable bladder with two sections separated by a divider creating a passageway. | ¶38 | col. 5:27-35 |
| said inflation port is connected within said first section... and a pressure sensor that is adapted to measure an air pressure... is connected within said second section | The Accused Products allegedly have an inflation port connected to the first section and a pressure sensor connected to the second section. | ¶39-40 | col. 6:2-9 |
| wherein said air flows from said inflation port to said pressure sensor through said first section | The Accused Products are alleged to comprise a system where air flows from the inflation port to the pressure sensor via the first section. | ¶41 | col. 10:11-13 |
| wherein said valve is adapted to enable air to flow only from said inflation port to said inflatable bladder through a first connection line to said first section to inflate said inflatable bladder | The Accused Products have a valve that allegedly enables air to flow only from the inflation port to inflate the bladder. | ¶42 | col. 6:53-60 |
| wherein said pressure sensor measures said air pressure of said inflatable bladder through a second connection line to said second section | The Accused Products allegedly have a pressure sensor that measures bladder pressure through a second connection line to the second section. | ¶43 | col. 10:1-3 |
| wherein the second connection line is only used for measuring the air pressure of said inflatable bladder. | The Accused Products are alleged to have a second connection line that is used only for measuring air pressure. | ¶44 | col. 13:20-23 |
- Identified Points of Contention:
- Scope Questions: A central question may be whether the internal construction of the Accused Products meets the claim requirements for a "divider" that creates a "passageway." The complaint makes these allegations on "information and belief," which will require substantiation through discovery.
- Technical Questions: A key evidentiary hurdle will be proving the negative limitation that the "second connection line is only used for measuring" pressure. This requires a detailed understanding of the accused device’s internal fluid dynamics, which is not provided in the complaint.
’704 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an air pumping module comprising a power supply, an electronic control unit, a first pressure port, and a valve with at least an inflation port | The Accused Products are alleged to be portable systems with an air pumping module containing these components. | ¶57 | col. 4:59-62 |
| a flexible wrap comprising an inflatable bladder with a first section and a second section that is connected to said first section through a passageway, with said inflation port coupled to said first section... through a first line | The Accused Products allegedly have a wrap with a two-section bladder, a passageway, and an inflation port coupled to the first section by a first line. | ¶59 | col. 8:56-62 |
| a pressure sensor for measuring an air pressure... through said first pressure port that is coupled to said second section of said inflatable bladder through a second line | The Accused Products are alleged to have a pressure sensor that measures pressure from the second bladder section via a second line. | ¶60 | col. 9:1-10 |
| wherein said first pressure port is the only pressure sensing port coupled to said air pumping module | The Accused Products are alleged to have a first pressure port that is the only pressure sensing port on the module. | ¶61 | col. 11:3-5 |
| said air pumping module is mounted on said inflatable bladder | The Accused Products allegedly have an air pumping module that is mounted on the inflatable bladder. | ¶62 | col. 2:6-8 |
| said valve enables air to flow from said inflation port to said first section through said first line to inflate... and said air pressure is measured by said pressure sensor through said second line that does not provide air to inflate said inflatable bladder | The Accused Products allegedly have a valve and sensor arrangement that separates the inflation and pressure-sensing air paths. | ¶64 | col. 10:55-11:21 |
- Identified Points of Contention:
- Scope Questions: The construction of "mounted on said inflatable bladder" will be critical. The dispute may turn on whether this requires the module to be attached directly to the bladder material itself, or if attachment to the fabric wrap containing the bladder is sufficient.
- Technical Questions: As with the '475 Patent, proving the negative limitation that the pressure sensing line "does not provide air to inflate" will depend on evidence of the accused product's internal design and operation, which is not detailed in the complaint.
V. Key Claim Terms for Construction
The Term: "directly coupled" (’475 Patent, Claim 16)
- Context and Importance: This term defines the relationship between the pumping module and the wrap. Its construction is critical because the invention’s goal is to eliminate traditional, long tubes. The degree of "directness" will be a focus, as any intermediate or non-rigid fastening in the accused device could be argued to fall outside this limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the "pumping module may be attached to the flexible inflatable wrap and worn by a user," suggesting a functional, tubeless connection is the core concept (’475 Patent, col. 2:5-7). This supports a construction meaning integrated without long, detachable air hoses.
- Evidence for a Narrower Interpretation: An argument could be made that "directly" implies an immediate, fixed attachment with no intervening layers, pointing to the integrated appearance in the patent's figures as the required structure.
The Term: "mounted on said inflatable bladder" (’704 Patent, Claim 1)
- Context and Importance: This term is a primary structural limitation of the asserted claim. Practitioners may focus on this term because its definition could be dispositive of infringement. The question is whether mounting the module on the exterior fabric of the wrap, which in turn contains the bladder, satisfies this requirement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discloses that the "pumping module may be attached to the flexible inflatable wrap," which comprises the bladder (’704 Patent, col. 2:6-7). This may support an interpretation where "mounted on" refers to the entire wrap assembly.
- Evidence for a Narrower Interpretation: The claim language is arguably more specific than the general description. A defendant might argue that "on said inflatable bladder" requires physical contact with or direct attachment to the bladder material itself, as distinct from the fabric wrap that encloses it.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement allegations are based on Defendant providing the Accused Products along with "instructions, documentation, and other information" that allegedly encourage customers to use them in an infringing manner (Compl. ¶47, ¶67). Contributory infringement is alleged on the basis that the Accused Products are not staple articles of commerce, have no substantial non-infringing uses, and are especially adapted for infringement (Compl. ¶48, ¶68).
- Willful Infringement: Willfulness is alleged based on both pre- and post-suit knowledge. The complaint alleges pre-suit knowledge by claiming Defendant's principals previously sold the licensed VenaPro® product, were aware of "patents pending" markings on that product, and knew of the published '475 patent application before forming ManaMed (Compl. ¶19, ¶26). Post-suit knowledge is based on the issuance of the patents and the filing of the lawsuit (Compl. ¶45, ¶65).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "mounted on said inflatable bladder" (’704 Patent) be construed to cover a control module attached to the exterior fabric of a wrap that contains a bladder, or does it require direct physical attachment to the bladder material itself? The resolution of this and similar construction issues like "directly coupled" (’475 Patent) will be fundamental to the infringement analysis.
- A key evidentiary question will be one of technical proof: can Plaintiff substantiate, beyond its "information and belief" pleadings, that the internal mechanics of the Accused Products meet the specific negative limitations of the claims—for instance, that a pressure-sensing line is "only used for measuring" pressure (’475 Patent) and "does not provide air to inflate" the bladder (’704 Patent)?
- A third central question relates to intent and knowledge: what evidence will emerge to support the narrative that Defendant’s founders used knowledge of Plaintiff's technology, gained from their prior roles selling the licensed VenaPro® product, to develop a competing product? The answer will be critical to the claim for willful infringement and potential enhancement of damages.