Therapyprimes LLC v. 3M Co

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: TherapyPrimes LLC (Texas)
  • Defendant: 3M Co (Delaware); KCI USA, Inc. (Delaware)
  • Plaintiff’s Counsel: Katz PLLC
• Case Identification: 6:24-cv-00462, W.D. Tex., 09/09/2024
• Venue Allegations: Plaintiff alleges venue is proper in the Western District of Texas because Defendants maintain places of business in the district, including in San Antonio and Brownwood, employ sales representatives, and derive substantial revenue from selling the accused products within the district.
• Core Dispute: Plaintiff alleges that Defendants’ negative pressure wound therapy systems infringe patents related to disposable, self-contained vacuum sources.
• Technical Context: The technology resides in the field of medical devices, specifically negative pressure wound therapy (NPWT), where a controlled vacuum is applied to a wound to promote healing and manage exudate.
• Key Procedural History: The complaint alleges that Plaintiff provided Defendants with notice of the patents-in-suit and detailed infringement allegations via letters dated June 26, 2023, and July 10, 2023. These notices establish a date from which Plaintiff alleges willful infringement. The complaint also notes that Defendant 3M acquired Acelity Inc. and its subsidiary KCI USA, Inc. in 2019; Acelity had previously acquired the underlying technology from Spiracur Inc. in 2015.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 8,512,301 - Canned Vacuum (Issued Aug. 20, 2013)

The Invention Explained

• Problem Addressed: The patent describes conventional medical suction devices, such as urine collectors, as often requiring external pumps, which can be inconvenient, or as being prone to spillage and odor if unpowered. (’301 Patent, col. 1:5-10; col. 2:50-55).
• The Patented Solution: The invention is a disposable, portable apparatus that contains a "built-in vacuum pressure." (’301 Patent, col. 3:19-22). It consists of a pre-evacuated container, a contact member to interface with a patient's body, and a valve. When the valve is opened, the pre-existing vacuum in the container provides suction force without an external pump, allowing it to collect and seal fluids. (’301 Patent, Abstract; col. 3:51-67).
• Technical Importance: This approach provides a low-cost, single-use vacuum source for various medical applications, enhancing portability and convenience by eliminating the need for separate, often bulky, power sources or pumps. (’301 Patent, col. 5:13-16).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 2, 5, 6, and 7. (Compl. ¶29).
• Independent Claim 1 recites an apparatus with the following key elements:
  • A "vacuum container" configured to maintain a "built-in vacuum pressure".
  • A "contact member" to enclose a surface area.
  • A "vacuum device" to couple the vacuum pressure to the surface area.
  • The vacuum container is also configured to "retain a substance" collected from the surface.
  • The vacuum container comprises a "collapsible container".
  • The collapsible container comprises a "spring member" configured to "maintain a tension in a wall" of the container.
• The complaint does not explicitly reserve the right to assert other claims.

U.S. Patent No. 9,339,595 - Disposable Vacuum Source and Medical Applications Thereof (Issued May 17, 2016)

The Invention Explained

• Problem Addressed: As a continuation of the ’301 patent, this patent addresses the same fundamental problem: the reliance of conventional systems on external power sources like electrical pumps for creating a vacuum. (’595 Patent, col. 1:12-15).
• The Patented Solution: The invention again describes a self-contained, disposable apparatus with a pre-evacuated container that provides suction. This patent explicitly adds a "conduit" to connect the contact member to the vacuum container and broadens the described applications to include not just collection but also therapies like acupressure, skin care, and uterine tissue extraction. (’595 Patent, Abstract; col. 2:20-34).
• Technical Importance: It expands the utility of the "canned vacuum" concept to a wider range of disposable medical procedures where a portable, unpowered suction source is advantageous. (’595 Patent, col. 5:11-18).

Key Claims at a Glance

• The complaint asserts apparatus claim 1 and method claims 15 and 18. (Compl. ¶¶24, 34, 36).
• Independent Claim 1 recites an apparatus with the following key elements, which largely mirrors claim 1 of the ’301 patent but adds a conduit:
  • A "vacuum container" with "built-in vacuum pressure".
  • A "contact member".
  • A "vacuum device".
  • A "conduit" coupled to the vacuum container.
  • The container retains a collected substance.
  • The conduit directs the substance to the container and maintains "substantially the same level of vacuum pressure".
  • The container is a "collapsible container" with a "spring member" maintaining "tension".
• The complaint does not explicitly reserve the right to assert other claims.

III. The Accused Instrumentality

Product Identification

The complaint identifies the "3M Negative Pressure Wound Therapy Systems," with the "3M Snap Therapy System" cited as a specific example. (Compl. ¶17).

Functionality and Market Context

The Accused Products are used for negative pressure wound therapy. (Compl. ¶21). The system consists of components including a dressing that is applied to the wound, tubing, and a disposable cartridge that generates and contains the vacuum. (Compl. p. 5). The complaint includes a table of ordering information for the 3M Snap Therapy System, which depicts and describes components such as the "Snap Therapy Cartridge" and "Advanced Dressing Kit." (Compl. p. 5). An "Instructions for Use" document cited in the complaint states the system is "Manufactured For KCI USA, Inc." (Compl. ¶23, p. 6). The complaint alleges these are commercially significant products sold throughout the United States. (Compl. ¶21).

IV. Analysis of Infringement Allegations

The complaint references Exhibits 2 and 4, which it describes as containing exemplary claim charts, but these exhibits were not filed with the complaint. (Compl. ¶¶29, 34). In the absence of these exhibits, the infringement theory is summarized below based on the complaint's narrative allegations.

’301 and ’595 Patent Infringement Allegations

The complaint alleges that the 3M Snap Therapy System embodies the claimed invention. (Compl. ¶¶24, 29). The plaintiff's infringement theory appears to map the components of the accused system to the elements of the asserted claims. The "Snap Therapy Cartridge" is alleged to be the "vacuum container" with "built-in vacuum pressure." (Compl. p. 5). The wound "Dressing Kit" likely corresponds to the "contact member," and the tubing connecting the dressing to the cartridge corresponds to the "conduit" element of the ’595 patent. (Compl. p. 5). The system as a whole, when activated, allegedly functions as the claimed "vacuum device" that applies a suction force to the wound site (the "surface area") to draw and retain exudate.

• Identified Points of Contention:
  • Technical Questions: A primary technical question will be whether the "Snap Therapy Cartridge" operates in the manner required by the claims. Specifically, what evidence does the complaint or subsequent discovery provide that the cartridge is a "collapsible container" and, critically, that it contains a "spring member configured to maintain a tension" to generate the vacuum? The physical construction and mechanism of the cartridge will be a central point of dispute.
  • Scope Questions: For the ’595 patent, a point of contention may arise over whether the tubing in the accused system meets the limitation of a "conduit... configured to... maintain substantially the same level of vacuum pressure as the vacuum container." Defendants may argue that any practical tubing system inherently involves a pressure drop and does not "maintain" the same pressure level.

V. Key Claim Terms for Construction

The Term: "collapsible container"

• Context and Importance: This term appears in the independent claims of both asserted patents and is foundational to the claimed structure. The infringement analysis will depend on whether the accused "Snap Therapy Cartridge," which promotional materials depict as a semi-rigid canister, falls within the scope of this term.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification discusses multiple embodiments, including a "solid plastic bottle" and a "collapsed plastic bottle," suggesting "container" is a broad category. (’301 Patent, col. 4:32-36). A plaintiff may argue that "collapsible" does not require the container to be completely flattened, but rather to be capable of changing its internal volume or state to generate pressure.
  • Evidence for a Narrower Interpretation: The specification explicitly describes an embodiment as a "collapsed plastic bottle" and another as a "collapsible container with a supporting structure." (’301 Patent, col. 4:38-39). A defendant may argue this language, combined with the ordinary meaning of "collapsible," implies a flexible, non-rigid structure, unlike a hard-shell cartridge.

The Term: "spring member configured to maintain a tension in a wall of the vacuum container"

• Context and Importance: This limitation describes the mechanism that allegedly generates the "built-in vacuum pressure" in the claimed collapsible container. Proving the existence and function of this element in the accused product is essential for the plaintiff's infringement case.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The specification describes tension being provided by "external spring-like structure" or "built-in tension from skeleton-like structures." (’301 Patent, col. 4:24-25, 36-38). Practitioners may argue that "spring member" should be construed functionally to cover any resilient component or material property that creates a restoring force, not just a conventional mechanical spring.
  • Evidence for a Narrower Interpretation: A defendant would likely argue that the claim requires a structurally distinct "spring member." The patent’s description of "skeleton-like structures" or an "external spring-like structure" could be used to argue that the claim requires more than just the inherent elasticity of the container material itself. (’301 Patent, col. 4:24-25, 36-38).

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendants induce infringement by providing customers with products along with "instructions, user manuals, advertising, and/or marketing materials which facilitate, direct or encourage" the use of the accused systems in an infringing manner. (Compl. ¶¶14, 31, 36, 42).
• Willful Infringement: The complaint alleges willful infringement based on Defendants' alleged knowledge of the patents-in-suit since at least June 30, 2023, and July 23, 2023, the dates they allegedly received notice letters that included claim charts. (Compl. ¶¶24, 39, 40). It further alleges that Defendants continued their infringing conduct despite this notice and have "no reasonable non-infringement theories." (Compl. ¶43).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of claim construction and technical proof: can the accused "3M Snap Therapy Cartridge" be proven to be a "collapsible container" that operates using a "spring member configured to maintain a tension"? The resolution of the case may hinge on whether the product’s actual mechanism for generating negative pressure can be persuasively mapped onto these specific claim limitations.
• A key evidentiary question will be one of functional mapping: in the absence of detailed technical allegations or claim charts in the complaint, discovery will be critical for the plaintiff to demonstrate that the accused system’s components perform the functions required by the claims. The defense will likely focus on any mismatches between the claimed structure and the product’s real-world operation.
• The allegation of willful infringement will turn on the defendants' state of mind after receiving pre-suit notice. A central question for the court will be whether the defendants' continued conduct was objectively reckless in light of the plaintiff's infringement allegations, an inquiry that will depend heavily on the credibility of any non-infringement or invalidity defenses that are ultimately presented.