DCT
7:22-cv-03719
Molnlycke Health Care US LLC v. Greenwood Marketing LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Mölnlycke Health Care US, LLC (Delaware) and Brock USA, LLC (Colorado)
- Defendant: Greenwood Marketing, LLC d/b/a Restorative Medical or Spry Therapeutics (New York)
- Plaintiff’s Counsel: Kilpatrick Townsend & Stockton LLP
- Case Identification: 7:22-cv-03719, S.D.N.Y., 05/06/2022
- Venue Allegations: Venue is alleged to be proper based on Defendant having a regular and established place of business in White Plains, New York, and committing acts of infringement within the district.
- Core Dispute: Plaintiffs allege that Defendant’s "Flo-Form" medical positioners infringe patents related to the composition of fluidized padding materials and the methods used to manufacture them.
- Technical Context: The technology concerns fluidized, moldable support cushions used in medical settings, primarily for preventing pressure ulcers (bedsores) in immobilized patients by distributing pressure and maintaining body alignment.
- Key Procedural History: The complaint details a complex prior relationship between the parties. Plaintiff MHC acquired intellectual property, including one of the patents-in-suit, from the principals of the Defendant. The parties previously entered into, and later amended, a license agreement restricting Defendant's use of the patents to specific "over-the-counter" fields of use. The complaint also references a prior 2020 patent infringement lawsuit between the parties that was settled. This history suggests Defendant had pre-existing knowledge of the patents and their scope.
Case Timeline
| Date | Event |
|---|---|
| 2007-08-29 | ’585 Patent Priority Date |
| 2011-06-09 | ’666 Patent Priority Date |
| 2012-05-08 | ’585 Patent Issued |
| 2012-06-01 | Restorative Medical takes a license to the ’585 Patent (approx.) |
| 2015-09-01 | ’666 Patent Issued |
| 2016-02-01 | MHC acquires ’666 Patent from Defendant's principals (approx.) |
| 2020-12-01 | Prior lawsuit between parties settles (approx.) |
| 2021-04-02 | MHC sends infringement notice letter to Defendant |
| 2021-05-01 | Defendant allegedly begins infringing sales (approx.) |
| 2022-05-06 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,120,666, “METHOD AND SYSTEM OF CHANGING FLOW CHARACTERISTICS OF A SUPPORT,” issued September 1, 2015
The Invention Explained
- Problem Addressed: The patent addresses the need for medical positioning aids that can be customized to have different levels of stiffness or "flow characteristics" while remaining moldable and having no "memory" of a prior shape (Compl. ¶¶ 1-2; ’666 Patent, col. 1:26-30). Conventional supports were often either too rigid or not customizable for different clinical needs, such as a very soft support for an ICU versus a stiffer one for an operating room (’666 Patent, col. 2:38-42).
- The Patented Solution: The invention is a manufacturing method for creating a support with a specific, permanent flow characteristic. This is achieved by taking a bladder filled with a "fluidized particulate material" and evacuating a predetermined amount of the interstitial gas via vacuum to a specific pressure level before permanently sealing the bladder (’666 Patent, Abstract). By controlling the final internal pressure, which is maintained permanently, manufacturers can produce supports with a range of customized stiffness levels from the same base materials (’666 Patent, col. 2:32-45).
- Technical Importance: This method provides a way to mass-customize support products for different medical applications, creating a spectrum of softness and support from a single manufacturing line.
Key Claims at a Glance
- The complaint asserts independent claim 1 and notes that claims 1-23 are directed to the patented method (Compl. ¶20, ¶39).
- Independent Claim 1 recites a method with the following essential steps:
- Providing a support comprising a bladder including a fluidized particulate material with gas-filled interstitial spaces.
- Evacuating the gas by vacuum to a predetermined pressure.
- Sealing the bladder such that the predetermined pressure is maintained permanently to achieve a predetermined permanent flow characteristic.
U.S. Patent No. 8,171,585, “LIGHTWEIGHT FLUID,” issued May 8, 2012
The Invention Explained
- Problem Addressed: Padding materials used in medical cushions often suffer from several drawbacks. They can be heavy, lack resilience, or develop "hard spots" when filler materials separate from the fluid and clump together, which can cause discomfort and pressure sores (’585 Patent, col. 3:17-28).
- The Patented Solution: The patent describes a composite "lightweight fluid" for use in padding. The solution consists of a bladder containing relatively large, closed-cell foam beads that are "exceedingly flooded" by a surrounding fluid (’585 Patent, Abstract). The term "exceedingly flooded" indicates that the interstitial spaces between the beads are completely filled with fluid, preventing the beads from separating and allowing the composite to act as a uniform, shock-absorbing medium (’585 Patent, col. 4:46-56).
- Technical Importance: This composite fluid creates a lightweight, compressible, and resilient padding material that avoids the "hard spot" and separation problems of prior art fluids, making it highly suitable for pressure-relief applications.
Key Claims at a Glance
- The complaint asserts independent claim 3 (Compl. ¶27, ¶46).
- Independent Claim 3 recites a fluid pad with the following essential elements:
- A fluid pad comprising a bladder, closed-cell foam beads, and a surrounding fluid.
- The beads and fluid comprise a composite fluid.
- The closed-cell foam beads are substantially impervious to the surrounding fluid.
- The closed-cell foam beads are "exceedingly flooded" by the surrounding fluid such that interstitial spaces between the beads are filled.
- The bladder houses the composite fluid.
III. The Accused Instrumentality
Product Identification
The accused products are the "Flo-Form" positioner and other "Spry positioners" sold by Defendant (Compl. ¶8, ¶28).
Functionality and Market Context
- The accused products are "fluidized positioners" marketed and sold directly to medical institutions for clinical use, not for over-the-counter retail sale (Compl. ¶8).
- According to Defendant’s marketing materials, the Flo-Form positioner is a "non-powered fluidized medium" designed to "easily contour to the patient's body and maintains its shape until remolded" (Compl. Fig. 2). A promotional video screenshot is provided to show the "fluidized nature" of the positioners (Compl. Fig. 1, ¶29).
- Plaintiffs allege that the positioners contain closed-cell foam beads made of Poly(ethylene), based on visual inspection and Fourier Transform Infrared (FTIR) spectroscopy tests performed on a product sample obtained at a medical conference (Compl. ¶33-34).
IV. Analysis of Infringement Allegations
’666 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) providing a support, said support comprising a bladder, said bladder including a fluidized particulate material including interstitial spaces...with said gas... | The accused Flo-Form positioner is a support in a bladder described as a "fluidized medium." | ¶39, Fig. 2 | col. 2:46-54 |
| (b) evacuating said gas filling said interstitial spaces by vacuum to a predetermined pressure | The complaint alleges that for the product to "maintain its shape" as advertised, it must be manufactured by evacuating gas to a sub-atmospheric pressure. This is supported by photographs from a "pinch test" comparing the accused product to a version created without a vacuum (Compl. Figs. 4, 5). | ¶31, ¶32, ¶39 | col. 2:59-64 |
| (c) sealing said bladder...the predetermined pressure is maintained permanently within the support to achieve a predetermined permanent flow characteristic... | The complaint alleges the product is sealed to permanently maintain the sub-atmospheric pressure, which provides its moldable, shape-retaining characteristic. | ¶39 | col. 3:11-17 |
Identified Points of Contention
- Technical Question: A central factual dispute will be whether the accused Flo-Form positioner is, in fact, manufactured using a vacuum to achieve a permanent, sub-atmospheric internal pressure. The complaint's evidence is inferential, arguing that the product's observed characteristics are achievable "unless a sub-atmospheric pressure is maintained" (Compl. ¶32). This raises the question of what evidence will demonstrate the actual manufacturing process.
- Scope Question: The parties may dispute whether the accused product's ability to be "remolded" falls within the scope of a "predetermined permanent flow characteristic" as taught by the patent.
’585 Patent Infringement Allegations
| Claim Element (from Independent Claim 3) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A fluid pad comprising a bladder, closed-cell foam beads and a surrounding fluid... | The accused Flo-Form positioner is alleged to be a fluid pad in a bladder containing a composite fluid of closed-cell foam beads and a surrounding fluid. | ¶46 | col. 4:20-27 |
| the closed-cell foam beads are substantially impervious to the surrounding fluid | The complaint alleges the beads are Poly(ethylene) and provides a photograph showing the outlines of beads within the product (Compl. Fig. 6). Based on industry knowledge, such beads are alleged to be closed-cell and therefore impervious. | ¶34, ¶46 | col. 6:17-20 |
| the closed-cell foam beads are exceedingly flooded by the surrounding fluid so that interstitial spaces...are filled with the...fluid | The complaint alleges the product meets this limitation by tracking the claim language. The allegation is based on the product being a "fluidized positioner" where the beads are within the surrounding fluid. | ¶46 | col. 5:4-10 |
| the bladder houses the composite fluid within the interior of the bladder | The accused product is a bladder containing the alleged composite fluid. | ¶46 | col. 4:21-22 |
Identified Points of Contention
- Scope Question: The construction of the term "exceedingly flooded" will be critical. The patent distinguishes this state from "exactly flooded" and "underflooded" systems (’585 Patent, col. 4:35-65). Whether the accused product's fluid-to-bead ratio meets the specific definition of "exceedingly flooded" will be a primary point of contention.
- Technical Question: Does the accused product actually contain "closed-cell foam beads" as required by the claim? While the complaint provides FTIR evidence identifying Poly(ethylene), the Defendant may challenge this analysis or argue the beads are not "closed-cell" as that term is understood in the patent.
V. Key Claim Terms for Construction
For the ’666 Patent
- The Term: "predetermined pressure"
- Context and Importance: This term is the foundation of the infringement allegation against the '666 patent. The entire case for infringement rests on whether Defendant's manufacturing process involves evacuating gas to a specific, non-atmospheric pressure that is set in advance. Practitioners may focus on this term because the Defendant has already denied using sub-atmospheric pressure in its process (Compl. ¶30).
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent discloses a wide range of potential pressures, "from about 500 millibars...to about 5 millibars to zero" (’666 Patent, col. 2:62-64), which could be argued to cover any level of sub-atmospheric pressure.
- Evidence for a Narrower Interpretation: The specification consistently links the "predetermined pressure" to the goal of achieving a customized flow characteristic, distinguishing it from a simple vacuum process that renders a support rigid (’666 Patent, col. 2:32-38). A defendant could argue that their process, even if it involves some pressure change, does not do so for the claimed purpose of creating a specific, permanent flow property.
For the ’585 Patent
- The Term: "exceedingly flooded"
- Context and Importance: This term is crucial for distinguishing the claimed invention from prior art padding systems. The infringement analysis will depend heavily on whether the quantity of fluid relative to the beads in the accused product meets the specific criteria of being "exceedingly flooded."
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes this state as one where the beads "can be essentially floating in the surrounding fluid" (’585 Patent, col. 5:7-8), which may support an interpretation covering any system where beads are not tightly packed.
- Evidence for a Narrower Interpretation: The patent explicitly contrasts an "exceedingly flooded" system with an "exactly flooded" system where fluid "substantially only occupy the interstitial spaces" (’585 Patent, col. 4:37-39). This comparison suggests "exceedingly flooded" requires a specific, quantifiable excess of fluid beyond what is necessary to merely fill the gaps between beads.
VI. Other Allegations
- Indirect Infringement: While the complaint's formal counts are for direct infringement, it alleges facts that could support indirect infringement, such as Defendant's marketing and sale of the products for infringing uses, and providing instructions for use (Compl. ¶8, ¶15, Fig. 2).
- Willful Infringement: The complaint alleges willful infringement for both patents. The allegations are supported by assertions of Defendant’s pre-suit knowledge based on the parties' extensive history. For the ’666 Patent, Defendant's principals are the named inventors who assigned the patent to MHC, and Defendant had a limited license (Compl. ¶17, ¶40). For the ’585 Patent, Defendant has held a license since at least June 2012 (Compl. ¶47). Plaintiffs also sent an infringement notice letter on April 2, 2021, providing a basis for post-notice willfulness (Compl. ¶30).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual proof: can Plaintiffs produce direct evidence that Defendant's manufacturing process for the "Flo-Form" positioner includes the step of evacuating gas to a "predetermined pressure" as required by the '666 patent, or will the case turn on inferences drawn from the product's physical characteristics?
- A key legal question will be one of claim construction: can the term "exceedingly flooded" from the '585 patent be defined with sufficient precision to determine whether the accused product's composition—specifically its fluid-to-bead ratio—falls within the scope of the claim?
- The parties' extensive prior relationship, including inventorship and license agreements, will likely be a significant factor, particularly in the court's assessment of knowledge and intent for the willfulness claims, potentially limiting the defenses available to the Defendant.