DCT
2:25-cv-00390
Merit Medical Systems Inc v. Medline Industries
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Merit Medical Systems, Inc. (Utah)
- Defendant: Medline Industries, LP (Illinois)
- Plaintiff’s Counsel: Dorsey & Whitney LLP
- Case Identification: 2:25-cv-00390, D. Utah, 05/16/2025
- Venue Allegations: Plaintiff alleges venue is proper in the District of Utah because Defendant Medline has engaged in infringing activity in the district and maintains a regular and established place of business there, specifically an established distribution center.
- Core Dispute: Plaintiff alleges that Defendant’s NAMIC-branded digital inflation device infringes three patents related to inflation syringes featuring improved digital displays and modular assembly methods.
- Technical Context: The technology involves medical inflation devices, used in procedures like angioplasty, which combine a syringe mechanism with an electronic display to provide clinicians with precise, real-time pressure information.
- Key Procedural History: The complaint alleges that Defendant Medline has extensive experience in patent litigation. It also alleges that Plaintiff has provided constructive notice of the asserted patents by continuously marking its commercial products.
Case Timeline
| Date | Event |
|---|---|
| 2008-05-09 | '202 Patent Priority Date |
| 2008-12-15 | '776 and '588 Patents Priority Date |
| 2010 | Plaintiff launches Blue Diamond® device |
| 2011-02-22 | U.S. Patent No. 7,892,202 Issues |
| 2012-02-21 | U.S. Patent No. 8,118,776 Issues |
| 2013-03-19 | U.S. Patent No. 8,398,588 Issues |
| 2018 | Plaintiff launches DiamondTOUCH™ device |
| 2019 | Medline acquires the NAMIC® brand from Angiodynamics, Inc. |
| 2025-03 | Medline allegedly begins offering infringing NAMIC device |
| 2025-05-16 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,892,202 - "System and Method for Inflation Syringe with Improved Display," Issued February 22, 2011
The Invention Explained
- Problem Addressed: The patent describes prior art electronic inflation syringes as having simplistic displays, such as a single numeric readout. This requires a practitioner to "expend mental effort and time to access the additional information, interpret the relevance of the data, and determine how the different values interrelate" during a medical procedure ('202 Patent, col. 2:40-44).
- The Patented Solution: The invention is an inflation syringe with an improved display that presents pressure information in two ways simultaneously: a precise numeric value and a "progressive non-numeric" visual indicator, such as an arc of bars ('202 Patent, Fig. 3A). This dual-mode display is designed to allow a practitioner to intuitively monitor the general intensity of pressure, track changes, and observe relationships between current and target/maximum pressures without needing to interpret only numerical values ('202 Patent, col. 2:62-col. 3:9).
- Technical Importance: This combined numeric and graphical interface aimed to reduce the cognitive load on clinicians during high-stakes procedures, potentially improving ease of use and safety.
Key Claims at a Glance
- The complaint asserts claims 1, 2, 3, 4, 5, 6, and 8 (Compl. ¶ 76).
- Independent Claim 1 requires, among other elements:
- An inflation syringe with a barrel, plunger, and a sensor for sensing pressure.
- A display mounted to the barrel.
- The display includes a "numeric indicator" for the current pressure.
- The display also includes a "plurality of discrete non-numeric indicia" for a non-numeric representation of the current pressure.
- The non-numeric indicia are actuated in a "progressive manner" as pressure changes.
- The non-numeric indicia "simultaneously provide a non-numeric representation of a value that is different from the current inflation pressurization".
U.S. Patent No. 8,118,776 - "System and Method for Inflation Syringe with Improved Display and Modularized Component Assembly," Issued February 21, 2012
The Invention Explained
- Problem Addressed: In addition to the display usability issues addressed in the '202 Patent, this patent addresses a manufacturing challenge. Assembling complex electronic displays with disposable syringe components can be inefficient, as a defect in a single sub-component could require the entire, otherwise functional, device to be discarded ('776 Patent, col. 4:15-20).
- The Patented Solution: The invention discloses a "modularized component assembly" for an inflation syringe. This design allows individual components—such as the display module, the electronic circuitry, and the syringe barrel—to be tested independently before final assembly ('776 Patent, col. 4:8-14). The patent describes a specific housing structure with a base and a hood to facilitate this modular assembly.
- Technical Importance: This modular approach sought to improve manufacturing yield and reduce costs by allowing for the isolation and replacement of defective sub-components before they are integrated into a final product.
Key Claims at a Glance
- The complaint asserts at least claim 1 (Compl. ¶ 83).
- Independent Claim 1 of the '776 Patent requires, among other elements:
- A "modularized component assembly" for an inflation syringe including a barrel, plunger, sensor, display processor, and display module.
- The display module includes both numeric and non-numeric indicators.
- A "display housing comprising a base and a hood".
- The "base" is configured to attach to the barrel and receive the processor and display module.
- The "hood" is configured to couple to the base to secure the processor and display module within the housing.
U.S. Patent No. 8,398,588 - "System and Method for Inflation Syringe with Improved Display and Modularized Component Assembly," Issued March 19, 2013
- Technology Synopsis: This patent claims a method for assembling a modular inflation device. The claimed process involves obtaining pre-assembled components, testing the operation of individual components like the processor and display module, and then physically assembling them by securing a housing base to the syringe barrel and coupling the processor and display module within the housing ('588 Patent, Claim 1). The method is intended to improve quality control and manufacturing efficiency.
- Asserted Claims: At least claim 1 is asserted (Compl. ¶ 90).
- Accused Features: The complaint accuses Medline's process for making the Infringing NAMIC Device of infringement, alleging that the devices are manufactured in China using the patented method and then imported into the U.S. in violation of 35 U.S.C. § 271(g) (Compl. ¶¶ 73, 90).
III. The Accused Instrumentality
- Product Identification: The accused product is Medline’s NAMIC brand digital inflation device (the "Infringing NAMIC Device") (Compl. ¶ 1).
- Functionality and Market Context: The complaint alleges the accused device is an inflation syringe used to inflate medical instruments, comprising a barrel, a plunger, a pressure sensor, and a digital display (Compl. ¶¶ 41-43). The device's display is alleged to provide both a numeric pressure reading and a non-numeric, progressive arc of bars to visually represent pressure (Compl. ¶¶ 44, 45). The complaint provides an image of the accused device's display showing both a large numeric readout and a surrounding graphical arc (Compl. p. 11). Plaintiff characterizes the accused product as a "low-cost, knock-off device" manufactured in China that directly competes with and undercuts the price of its own patented devices (Compl. ¶¶ 36, 38).
IV. Analysis of Infringement Allegations
'202 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a sensor apparatus for sensing inflation pressurization within the barrel | The device includes a pressure sensor, shown in a photograph as being located on an "FR4 Board," for sensing pressure inside the barrel (Compl. p. 10). | ¶42 | col. 6:15-20 |
| a display mounted to the exterior of the barrel | The device has a display mounted externally on the syringe barrel (Compl. p. 10). | ¶43 | col. 5:46-48 |
| a numeric indicator which provide a numeric indication of a current inflation pressurization within the barrel | The display provides a numeric value, such as "2.6 atm/0.1MPa," indicating the current pressure (Compl. p. 11). | ¶44 | col. 8:5-7 |
| a plurality of discrete non-numeric indicia which are actuated to provide a non-numeric representation of the current inflation pressurization | The display includes an arc of discrete bars that are actuated to represent the current pressure (Compl. p. 11). | ¶45 | col. 9:49-51 |
| wherein the non-numeric indicia are actuated in a progressive manner...as the pressurization increases and decreases | The complaint alleges the non-numeric bars remain actuated in a progressive manner as pressure increases. | ¶46 | col. 10:45-49 |
| and wherein the non-numeric indicia simultaneously provide a non-numeric representation of a value that is different from the current inflation pressurization. | The complaint alleges that after an initial inflation, a "high 'tick' mark" remains displayed to show the prior maximum pressure, which is a different value from the current pressure if the pressure has since been reduced. | ¶51 | col. 4:31-34 |
- Identified Points of Contention:
- Scope Question: A central issue may be the construction of the final limitation: "a value that is different from the current inflation pressurization." The complaint’s infringement theory relies on this language covering the display of a historical value (the prior maximum pressure). A defendant could argue this term should be limited to a concurrently relevant value, such as a user-set target pressure, rather than a past maximum.
- Technical Question: What evidence demonstrates that the accused device performs the "prior maximum" display function as alleged in paragraph 51? The complaint provides static images, but the dynamic behavior of retaining a "high 'tick' mark" is a key factual allegation that may require further proof.
'776 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a display housing comprising a base and a hood | An annotated X-ray image in the complaint purports to show the device has a display housing composed of a separate base and hood (Compl. p. 15). | ¶57 | col. 9:8-10 |
| wherein the base is configured to attach to the barrel and to receive the display processor and display module | The complaint alleges the base attaches to the syringe barrel and contains the internal electronic components. The X-ray image is provided as evidence. | ¶57 | col. 16:45-53 |
| and wherein the display hood is configured to couple to the display base and secure the display processor and display module within... | The complaint alleges the hood couples to the base, securing the processor and display module inside the completed housing (Compl. p. 15). | ¶57 | col. 18:30-32 |
- Identified Points of Contention:
- Technical Question: The infringement reading depends on the accused device having a specific "modularized" construction. The primary evidence offered is an annotated X-ray image (Compl. p. 15). The defense may challenge whether the accused device’s components and their assembly method truly map onto the claimed "base," "hood," and "modularized" architecture, or if it is a more integrated, non-modular design.
- Scope Question: Whether the accused device is a "modularized component assembly" may be a point of dispute. The patent links this term to the benefit of independent component testing. The complaint infers that Medline performs such testing via its quality control division (Compl. ¶ 59), but does not offer direct evidence. The definition of "modularized" may be contested.
V. Key Claim Terms for Construction
Term: "a value that is different from the current inflation pressurization" ('202 Patent, Claim 1)
- Context and Importance: This term is critical to the infringement allegation against the '202 Patent. The Plaintiff’s theory requires this term to encompass a historical value, specifically the prior maximum pressure achieved in an inflation routine (Compl. ¶ 51). Practitioners may focus on this term because its construction could determine whether a "memory" feature falls within the claim scope.
- Intrinsic Evidence for a Broader Interpretation: The specification states that the user interface can provide "additional data such as a last maximum pressurization value, a maximum routine pressurization value, or other pressurization values that are different from the current pressurization" ('202 Patent, col. 4:31-34). This language may support an interpretation that includes historical maximums.
- Intrinsic Evidence for a Narrower Interpretation: A party might argue that the patent’s overall focus is on values relevant to the immediate inflation procedure. For example, the specification also discusses displaying a "target pressurization value" ('202 Patent, col. 12:45-48), which could be argued as the intended meaning of a "different" value, rather than a purely historical marker.
Term: "modularized component assembly" ('776 Patent, Claim 1)
- Context and Importance: This term appears in the patent's title and is fundamental to the invention of the '776 Patent. Infringement depends on the accused device being constructed in a "modularized" fashion.
- Intrinsic Evidence for a Broader Interpretation: The term could be interpreted broadly to cover any device where the main electronic display unit and the main syringe body are manufactured as separate pieces and later joined.
- Intrinsic Evidence for a Narrower Interpretation: The specification strongly connects the "modularized" concept to the benefit of enabling independent testing of components before final assembly to reduce waste ('776 Patent, col. 4:8-20). A court might construe the term to require a specific architecture that facilitates this independent testing. If the accused device's assembly process does not lend itself to such pre-testing, it may not meet this narrower definition.
VI. Other Allegations
- Indirect Infringement: The complaint does not appear to allege indirect infringement. The causes of action focus on direct infringement under 35 U.S.C. §§ 271(a) and 271(g).
- Willful Infringement: The complaint alleges willful infringement for all three asserted patents (Compl. ¶¶ 77, 84, 91). The allegations are based on Medline’s alleged sophistication in patent matters from its history as a litigant and on alleged pre-suit knowledge of the patents from Plaintiff's product marking practices (Compl. ¶ 31).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "a value that is different from the current inflation pressurization" in the '202 Patent be construed to cover the accused device's alleged function of displaying a prior maximum pressure, or is its meaning limited to a concurrently relevant value like a target pressure?
- A key question for the '776 Patent will be one of technical structure: does the accused product’s construction, as shown in the complaint's X-ray evidence, embody the "modularized component assembly" with a distinct "base" and "hood" as claimed, or is there a fundamental mismatch in its physical architecture?
- A central evidentiary challenge for the '588 method patent will be whether the Plaintiff can obtain sufficient evidence from discovery to prove that Medline's manufacturing process, conducted in China, follows the specific sequence of testing and assembly steps required by the asserted method claims.