DCT
6:24-cv-00589
Wound Healing Tech Corp v. Solventum Corp
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Wound Healing Technologies Corp. (New York)
- Defendant: Solventum Corporation (Delaware/Minnesota); 3M Company (Delaware/Minnesota)
- Plaintiff’s Counsel: Bochner PLLC
- Case Identification: 6:24-cv-00589, W.D. Tex., 11/15/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendants have committed acts of infringement in the district and have a regular and established place of business in the district, specifically a "Negative Pressure Wound Therapy" customer support location in San Antonio, Texas.
- Core Dispute: Plaintiff alleges that Defendants’ negative pressure wound therapy dressing kits infringe a patent related to an integrated, multi-component wound dressing assembly.
- Technical Context: The technology relates to Negative Pressure Wound Therapy (NPWT), a widely used medical treatment that applies suction to a wound to promote healing and remove excess fluid.
- Key Procedural History: The complaint alleges that Plaintiff notified Defendant 3M of its infringement on January 5, 2023. It further alleges that on April 1, 2024, 3M "spun off" Defendant Solventum as a separate entity, which allegedly continued the infringement with knowledge derived from its association with 3M.
Case Timeline
| Date | Event |
|---|---|
| 2010-06-03 | ’404 Patent Priority Date |
| 2020-05-05 | ’404 Patent Issue Date |
| 2023-01-05 | Plaintiff allegedly notifies 3M of infringement |
| 2024-04-01 | 3M allegedly "spins off" Solventum |
| 2024-11-15 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,639,404 - “Wound Dressing,” issued May 5, 2020
The Invention Explained
- Problem Addressed: The patent describes conventional Negative Pressure Wound Therapy (NPT) application as a complex, multi-step process that is difficult and time-consuming for practitioners (’404 Patent, col. 2:35-44). Challenges include properly placing and securing a drainage tube within wound packing material and then draping the entire site to create an airtight seal, a procedure that risks component shifting and may be painful for the patient (’404 Patent, col. 2:1-6, 22-26).
- The Patented Solution: The invention is an integrated, multi-component wound dressing designed to streamline the NPT application process (’404 Patent, col. 3:8-10). As detailed in the abstract and illustrated in figures such as the exploded view in Figure 9, the dressing combines a fluid-absorbing layer, a vacuum/drainage tube, a vapor sealant sheet that overlies the absorbing material, and a tube-anchorage component into a single, pre-assembled apparatus (’404 Patent, Abstract; col. 3:16-65).
- Technical Importance: This all-in-one design aims to simplify the procedure for preparing a wound for NPT, potentially reducing application time, minimizing the risk of errors from component shifting, and mitigating patient pain associated with conventional methods (’404 Patent, col. 5:17-24).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims, "including but not limited to claim 3" (Compl. ¶16). Claim 3 is a dependent claim that incorporates all limitations of independent claim 1.
- Independent Claim 1 requires:
- A wound-fluid drain for use in NPT, configured to non-simultaneously withdraw and deliver fluid.
- A vacuum/drainage tube associated with the drain.
- A fluid-absorbing/transferring layer in contact with the drain.
- A vapor sealant sheet made of hydrocolloid material that overlies the absorbing layer and has an adhesive to maintain its position relative to that layer.
- A tube-anchorage component in contact with the vapor sealant sheet and the absorbing layer to mechanically maintain the drain's placement.
- Dependent Claim 3 further adds the limitation of:
- A "tube-exit-sealant component" for mechanically maintaining the vacuum/drainage tube's placement relative to the fluid-absorbing/transferring layer.
III. The Accused Instrumentality
Product Identification
- The "Snap Therapy System" and "Prevena Therapy System" product lines, including various enumerated model numbers (Compl. ¶14).
Functionality and Market Context
- The accused products are described as wound dressing kits used for negative pressure wound therapy (Compl. ¶2). The complaint alleges these kits include a combination of components that map to the elements of the asserted patent claims, including a vacuum/drainage tube, a fluid-absorbing layer, a hydrocolloid vapor sealant sheet, and a component for securing the tube's exit point (Compl. ¶¶20-23). The complaint includes several annotated images of the accused products to identify these features. For example, an annotated image of the Snap and Prevena systems points to the alleged "vacuum/drainage tube" (Compl. ¶20). Another image identifies the "fluid-absorbing/transferring layer" in both systems (Compl. ¶21).
IV. Analysis of Infringement Allegations
’404 Patent Infringement Allegations
| Claim Element (from Independent Claim 1 and Dependent Claim 3) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a vacuum/drainage tube comprising a terminus | The Accused Products include a wound dressing that includes a "vacuum/drainage tube." An annotated image of the Accused Products identifies the presence of a drainage tube. | ¶20 | col. 12:11-12 |
| a fluid-absorbing/transferring layer... being in contact with the vacuum/drainage tube | The Accused Products include a "fluid-absorbing/transferring layer" that is in contact with the tube. An annotated image identifies this layer. | ¶21 | col. 13:7-10 |
| a vapor sealant sheet formed from a hydrocolloid material, the vapor sealant sheet that overlies the fluid-absorbing/transferring layer | The Accused Products include a "vapor sealant sheet formed from a hydrocolloid material" that overlies the absorbing layer. | ¶22 | col. 14:10-14 |
| a tube-exit-sealant component for mechanically maintaining the vacuum/drainage tube's placement | The Accused Products include a "tube-exit-sealant component for mechanically maintaining the vacuum/drainage tube's placement." An annotated image identifies this component. | ¶23 | col. 16:50-59 |
Identified Points of Contention
- Technical Questions: Claim 1 requires the NPT drain to be "configured to non-simultaneously withdraw fluid from a wound and deliver fluid to the wound." The complaint's allegations focus on the structural components of the accused dressings (Compl. ¶¶20-23) but do not present facts suggesting the accused "vacuum/drainage tube" is configured for this specific bi-directional, non-simultaneous functionality. This raises the question of whether the accused products meet this functional limitation.
- Scope Questions: Claim 3 requires a "tube-exit-sealant component" for "mechanically maintaining the vacuum/drainage tube's placement." The dispute may raise the question of whether the accused feature, identified in an annotated image (Compl. ¶23), performs this specific mechanical maintenance function as required by the claim, or if its function is materially different.
V. Key Claim Terms for Construction
"configured to non-simultaneously withdraw fluid from a wound and deliver fluid to the wound"
- Context and Importance: This functional limitation appears in independent claim 1 and is therefore a predicate for infringement of asserted claim 3. As the complaint does not allege facts showing this functionality in the accused products, its interpretation will be critical. Practitioners may focus on this term because its construction could be dispositive of infringement.
- Intrinsic Evidence for a Broader Interpretation: A party may argue that "configured to" means "capable of," and that any standard tube through which flow can be reversed is sufficient. The patent does not appear to explicitly define the term.
- Intrinsic Evidence for a Narrower Interpretation: A party may argue the term implies a special design or structure intended for this purpose. The specification discusses the use of "multi-lumen vacuum/drainage tube 735" for facilitating multiple uses, including the "delivery via a lumen of medicinal fluids" and "wound-flushing" (’404 Patent, col. 12:32-36, col. 20:61-65). This could support an argument that "configured to" requires a specific structure, such as multiple lumens, not present in a standard drainage tube.
"tube-exit-sealant component"
- Context and Importance: This element is added by asserted dependent claim 3 and is identified in the complaint's infringement allegations. The definition of this term will determine the scope of the claim and whether the accused product's structure falls within it.
- Intrinsic Evidence for a Broader Interpretation: The patent describes the function of this component as providing "anchorage" and contributing to "airtightness to the tube-exit" (’404 Patent, col. 16:22-24). A party could argue that any structure that performs this general sealing and anchoring function meets the definition, regardless of its specific form.
- Intrinsic Evidence for a Narrower Interpretation: The patent illustrates this as a distinct, overlying layer (e.g., components 745 and 747 in Figs. 7A-7C), described as a separate component that "may overlie part or all of vapor sealant sheet 757" (’404 Patent, col. 16:41-42). A party could argue this requires a discrete structural element rather than a feature that is integral with another part of the dressing.
VI. Other Allegations
Indirect Infringement
- The complaint alleges inducement of infringement based on Defendants providing instructions, videos, and promotional materials that allegedly explain how to use the accused products in an infringing manner (Compl. ¶¶31-33). It also alleges contributory infringement based on the sale of "Accused Accessories" that are allegedly a material part of the invention and not staple articles of commerce (Compl. ¶¶34-36).
Willful Infringement
- Willfulness is alleged against 3M based on its knowledge of the ’404 Patent since at least January 5, 2023, following a notice letter from the Plaintiff (Compl. ¶¶25, 41). Willfulness is alleged against Solventum based on knowledge imputed from its "relationship and association with 3M" prior to and during its spin-off as a separate entity (Compl. ¶¶28, 42).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of functional capability: does the accused products' standard "vacuum/drainage tube" meet the claim requirement of being "configured to non-simultaneously withdraw fluid from a wound and deliver fluid to the wound," or does this limitation require a specialized structure for bi-directional flow that the accused products lack?
- The case will also present a question of claim scope: can the term "tube-exit-sealant component" be construed to read on the accused product's structure, or does the patent's description and figures require a more specific, discrete component than what is alleged to be present?
- Finally, a key legal question for willfulness and damages will be whether pre-spinoff knowledge of a patent held by a parent company (3M) can be imputed to a newly formed, spun-off entity (Solventum) to establish knowledge for the purpose of post-spinoff infringement.