Edge Systems LLC v. Image MicroDerm Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Edge Systems LLC (California) and AXIA MEDSCIENCES, LLC (Delaware)
  • Defendant: Image MicroDerm Inc. (Nevada)
  • Plaintiff’s Counsel: Knobbe, Martens, Olson & Bear, LLP
• Case Identification: 2:17-cv-08699, C.D. Cal., 12/01/2017
• Venue Allegations: Venue is alleged to be proper based on Defendant maintaining a regular and established place of business within the Central District of California and having committed acts of infringement in the district.
• Core Dispute: Plaintiffs allege that Defendant’s skin treatment systems infringe seven patents related to hydradermabrasion technology, which involves devices that abrade, hydrate, and cleanse skin using a combination of specialized tips, fluid delivery, and vacuum suction.
• Technical Context: The technology occupies the aesthetic dermatology market, offering a non-invasive procedure for skin exfoliation and rejuvenation that combines mechanical abrasion with the simultaneous delivery of topical solutions.
• Key Procedural History: The complaint alleges Defendant had pre-suit knowledge of several of the patents-in-suit via cease and desist letters sent in 2014 and 2017, which may form the basis for Plaintiffs' claims of willful infringement.

Case Timeline

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

U.S. Patent No. 6,641,591 - "INSTRUMENTS AND TECHNIQUES FOR CONTROLLED REMOVAL OF EPIDERMAL LAYERS"

• Patent Identification: U.S. Patent No. 6,641,591, "INSTRUMENTS AND TECHNIQUES FOR CONTROLLED REMOVAL OF EPIDERMAL LAYERS," issued November 4, 2003.

The Invention Explained

• Problem Addressed: The patent’s background section describes the drawbacks of prior art skin resurfacing techniques, noting that deep treatments (e.g., CO2 laser) involve significant risk and lengthy recovery periods, while superficial treatments (e.g., micro-dermabrasion) are less effective for many skin conditions (’591 Patent, col. 1:21-2:16, col. 3:1-7).
• The Patented Solution: The invention is a hand-held instrument that combines three functions: a vacuum source to draw skin into the device, a fluid source to deliver treatment media, and a skin interface with a specific abrading structure. This combination aims to provide controlled exfoliation while simultaneously hydrating the skin and removing debris, offering a more effective and less invasive treatment (’591 Patent, Abstract; col. 7:30-49). Figure 2 illustrates the overall system, including the handpiece (18), a negative pressure source (30), and a fluid/crystal source (50). (’591 Patent, Fig. 2).
• Technical Importance: This integrated approach of simultaneous abrasion, fluid infusion, and vacuum extraction represented a step forward in non-invasive aesthetic treatments, aiming to improve efficacy over simple abrasion alone. (’591 Patent, col. 2:21-34).

Key Claims at a Glance

• Independent Claim 1 is asserted (Compl. ¶41).
• Claim 1 elements include:
  • A system for treating the skin surface of a patient, comprising: an instrument body with a distal working end that defines a skin interface portion for contacting the skin;
  • a first aperture arrangement in said skin interface consisting of at least one port in communication with a treatment media source;
  • a second aperture arrangement in said skin interface consisting of at least one port in communication with a vacuum source for removing treatment media and removed tissue from the skin interface; and
  • wherein the skin interface comprises an abrading structure with substantially sharp edges for abrading tissue.
• The complaint reserves the right to assert additional claims (Compl. ¶38).

U.S. Patent No. 7,789,886 - "INSTRUMENTS AND TECHNIQUES FOR CONTROLLED REMOVAL OF EPIDERMAL LAYERS"

• Patent Identification: U.S. Patent No. 7,789,886, "INSTRUMENTS AND TECHNIQUES FOR CONTROLLED REMOVAL OF EPIDERMAL LAYERS," issued September 7, 2010.

The Invention Explained

• Problem Addressed: As a continuation of the application leading to the ’591 Patent, this patent addresses the same general problems in the field of skin resurfacing (’886 Patent, col. 1:15-2:65).
• The Patented Solution: This patent focuses more specifically on the structural arrangement of the handpiece's working surface. It describes a configuration where an outer periphery encircles both the abrasive structures and a vacuum aperture. This design purports to use the vacuum to draw the patient's skin against both the sealing outer periphery and the abrasive structures, facilitating simultaneous abrasion and aspiration of debris (’886 Patent, Abstract; col. 15:8-28). The relationship between the outer periphery (25A), abrasive ridges (62a), and central opening (26) is shown in Figure 3. (’886 Patent, Fig. 3).
• Technical Importance: The claimed geometry aims to create a more controlled and efficient interaction between the device and the skin by using a vacuum to maintain consistent contact for both abrasion and debris removal. (’886 Patent, col. 15:18-28).

Key Claims at a Glance

• Independent Claim 11 is asserted (Compl. ¶55).
• Claim 11 elements include:
  • A method for treating a skin surface of a patient, comprising: translating a working surface of a handheld device relative to the skin surface, said working surface comprising an abrasive structure configured to abrade the skin surface, an aperture in the working surface, an outer periphery that encircles the abrasive structure and the aperture, at least a portion of the abrasive structure spaced from the aperture; and
  • continuously applying a vacuum through the aperture formed in the working surface in order to draw the skin against the outer periphery and the abrasive structure and aspirate debris away from the working surface while abrading the skin surface.
• The complaint reserves the right to assert additional claims (Compl. ¶52).

Multi-Patent Capsules

• U.S. Patent No. 8,066,716: Issued November 29, 2011, titled "INSTRUMENTS AND TECHNIQUES FOR CONTROLLED REMOVAL OF EPIDERMAL LAYERS." This patent discloses a system with a handpiece having abrading structures, a vacuum aperture, an inflow port for delivering media, and a non-abrasive outer periphery that circumscribes these elements. The flowable media is configured to pass through the abrading structures before being removed by the vacuum aperture. Asserted Claim: 15. Accused Features: The entire system, including the handpiece, vacuum, and fluid delivery functions (Compl. ¶70).
• U.S. Patent No. 8,337,513: Issued December 25, 2012, titled "INSTRUMENTS AND TECHNIQUES FOR CONTROLLED REMOVAL OF EPIDERMAL LAYERS." This patent describes a system with a handpiece whose outer periphery is configured to contact the skin and circumscribe an interior area containing a plurality of surface elements with sharp edges for abrading skin. The handpiece also includes an aperture connected to a vacuum source to convey debris away. Asserted Claim: 1. Accused Features: The system's handpiece, interchangeable tips with surface elements, and vacuum functionality (Compl. ¶84).
• U.S. Patent No. 9,468,464: Issued October 18, 2016, titled "METHODS FOR TREATING THE SKIN USING VACUUM." This patent claims a method where activating a vacuum source in a handpiece simultaneously facilitates the delivery of liquid treatment media to the skin surface through a second port and aspirates used media away through a first port. The vacuum action is also alleged to hydrate or puff up the skin to facilitate treatment. Asserted Claim: 1. Accused Features: The method of using the Accused Products, where activating the vacuum facilitates both media delivery and aspiration (Compl. ¶¶98-99).
• U.S. Patent No. 9,550,052: Issued January 24, 2017, titled "CONSOLE SYSTEM FOR THE TREATMENT OF SKIN." This patent describes a system comprising a console with a manifold connected to at least two fluid containers, and a handpiece assembly connected via a supply conduit. The manifold is configured to control the flow of treatment material from the separate containers to the handpiece, allowing a user to select the treatment material. Asserted Claim: 11. Accused Features: The Accused MD Product, which allegedly includes a manifold, multiple fluid containers, and a handpiece assembly, allowing user selection of treatment fluids (Compl. ¶113).
• U.S. Patent No. 9,775,646: Issued October 3, 2017, titled "DEVICES AND SYSTEMS FOR TREATING THE SKIN USING VACUUM." This patent discloses a system with a handpiece having a distal end perimeter configured to contact the skin, a skin interface positioned within that perimeter, and first and second apertures for vacuum and treatment media, respectively. When the vacuum is activated, treatment media is delivered to the skin and simultaneously aspirated away. Asserted Claim: 13. Accused Features: The system's handpiece, tips, and the dual-functionality of the vacuum and fluid delivery systems (Compl. ¶127).

III. The Accused Instrumentality

Product Identification

• The BioXFusion MD ("Accused MD Product") and the smaller BioXFusion Mini ("Accused Mini Product"), collectively referred to as the "Accused Products" (Compl. ¶20). Photographs of the Accused MD Product and Accused Mini Product are provided in the complaint. (Compl. p. 5, ¶21; Compl. p. 6, ¶22).

Functionality and Market Context

• The Accused Products are described as systems for treating a patient's skin surface (Compl. ¶23). Each system includes a main unit housing a vacuum source and at least one fluid source, a handheld device ("handpiece"), and a variety of interchangeable tips (Compl. ¶¶23-24). The complaint alleges that some tips have abrading structures with "substantially sharp edges" (Compl. ¶25). In operation, the vacuum allegedly creates a seal between the handpiece and the skin, aids in depositing fluid on the skin, and carries away abraded skin cells and debris to a waste container (Compl. ¶¶25, p. 7:1-7). The complaint does not provide sufficient detail for analysis of the products' market positioning beyond identifying Plaintiffs as a "worldwide leader" in the field (Compl. ¶9).

IV. Analysis of Infringement Allegations

’591 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The complaint alleges the handpiece has separate ports for the media source and vacuum source. The infringement analysis may turn on whether the accused device's apertures and ports map onto the "first aperture arrangement" and "second aperture arrangement" as claimed.
  • Technical Questions: A key factual question will be whether the tips used with the Accused Products possess an "abrading structure with substantially sharp edges" as required by the claim. The evidence presented to support the "substantially sharp" nature of the edges will be critical.

’886 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Questions: The construction of the spatial term "encircles" will be central. The question will be whether the accused handpiece's structure constitutes an "outer periphery" that surrounds both the abrasive elements and the vacuum aperture in the manner claimed.
  • Technical Questions: An evidentiary question will be how the vacuum in the Accused Products functions. Does it, as alleged, actively draw the skin against both the periphery and the abrasive structures to cause abrasion, or does it primarily function to remove debris after abrasion occurs through manual pressure?

V. Key Claim Terms for Construction

• The Term: "abrading structure with substantially sharp edges" (’591 Patent, Claim 1)

• Context and Importance: This term defines the character of the operative part of the device. The degree of "sharpness" required by the claim will be a central issue, as it distinguishes the claimed invention from surfaces that might merely be rough or textured. Practitioners may focus on this term because the functionality of the accused tips will be compared against this standard.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The specification describes the structure more generally as an "irregular or ridged surface structure" (’591 Patent, col. 3:9-12), which could suggest that a variety of non-uniform surfaces, not just knife-like edges, are contemplated.
  • Evidence for a Narrower Interpretation: Embodiments in the specification depict "primary surface elements 255a and secondary surface elements" that "define teeth therebetween" (’591 Patent, col. 8:62-65). Figures 7-9 show distinct, tooth-like projections, which might support a narrower construction requiring discrete, sharp-edged features.

• The Term: "an outer periphery that encircles the abrasive structure and the aperture" (’886 Patent, Claim 11)

• Context and Importance: This phrase dictates the specific geometric layout of the working surface. The infringement analysis for the ’886 Patent will depend heavily on whether the accused device's tip geometry meets this spatial requirement. The term "encircles" implies a specific positional relationship that will likely be disputed.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The plain meaning of "encircle" could be read broadly to mean "surround in any manner." The claim language does not specify that the periphery must be continuous or of a particular shape.
  • Evidence for a Narrower Interpretation: The specification states that a purpose of the shape is "to cause the outer periphery of the working end to be in firm contact with the tissue surface while the negative pressure from aspiration source 30 draws the skin into firm contact" (’886 Patent, col. 6:55-59). This functional language may imply that "outer periphery" means a continuous, raised rim capable of forming a seal, as depicted by element 25A in Figure 3.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that Defendant induces infringement by selling the Accused Products to its customers (Compl. ¶26). It further alleges that Defendant knew its customers would infringe by using the products and had the specific intent to cause that infringement (Compl. ¶¶29-30, 43-44, 58-59).
• Willful Infringement: The willfulness allegations are based on alleged pre-suit knowledge. The complaint asserts that Defendant had actual knowledge of the ’591, ’886, ’716, and ’513 patents no later than April 8, 2014, and of the ’464 patent no later than July 19, 2017, as a result of cease and desist letters from Plaintiffs (Compl. ¶28). Knowledge of the ’052 and ’646 patents is alleged as of the filing of the complaint (Compl. ¶28).

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

• A core issue will be one of definitional scope: how will the court construe terms of degree and spatial relationship, such as "substantially sharp edges" and "encircles"? The outcome of claim construction for these terms may significantly influence the infringement analysis, particularly whether a textured surface meets the "sharp edges" requirement and whether the accused tip's geometry satisfies the "encircles" limitation.
• A second central issue will be one of factual proof of operation: what evidence will demonstrate how the Accused Products' vacuum, fluid delivery, and tip structures actually interact with a user's skin? The case may turn on whether the vacuum's primary function is merely aspirational, as in prior art devices, or if it actively draws skin against the abrasive structures and outer periphery to perform the specific methods claimed in the patents.
• Finally, a key question for damages will be willfulness: given the allegations of pre-suit notice via letters dating back to 2014, the court will have to determine whether Defendant's alleged infringement, if any, was willful, which could expose the defendant to enhanced damages.