DCT

2:24-cv-06250

HydraFacial LLC v. Sinclair Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:24-cv-06250, C.D. Cal., 07/24/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because Defendant Sinclair Pharma US, Inc. resides and has a regular and established place of business in the district; for the other foreign and out-of-state defendants, Plaintiff alleges that a substantial part of the events giving rise to the claims occurred in the district.
  • Core Dispute: Plaintiff alleges that Defendants’ Préime hydrodermabrasion system and its associated "AquaB" treatment tips infringe five U.S. patents related to skin treatment consoles, methods, and removable tips.
  • Technical Context: The technology concerns hydrodermabrasion systems, which are aesthetic medical devices that exfoliate, cleanse, and hydrate skin by delivering treatment fluids while simultaneously using a vacuum to remove waste and impurities.
  • Key Procedural History: The complaint alleges that Defendants had knowledge of the asserted patents prior to the lawsuit. Plaintiff states it sent a notice letter to Defendants Sinclair Pharma and Sinclair Pharma US around October 10, 2023, identifying four of the five patents-in-suit. A subsequent letter was sent on July 19, 2024, regarding the fifth patent after its issuance. Plaintiff also alleges constructive knowledge of at least one patent via Plaintiff's public patent listings on its website since June 2018.

Case Timeline

Date Event
2005-12-30 U.S. Patent No. 11,865,287 Priority Date
2015-04-28 U.S. Patent No. 9,550,052 Priority Date
2015-04-30 U.S. Patent Nos. 10,357,641, 10,357,642, & 11,446,477 Priority Date
2017-01-24 U.S. Patent No. 9,550,052 Issues
2018-06-01 Plaintiff alleges its website listed the ’052 Patent, providing notice to competitors
2019-07-23 U.S. Patent Nos. 10,357,641 and 10,357,642 Issue
2022-09-20 U.S. Patent No. 11,446,477 Issues
2023-10-10 Plaintiff sends notice letter to Defendants regarding four of the asserted patents
2024-01-09 U.S. Patent No. 11,865,287 Issues
2024-07-19 Plaintiff sends notice letter to Defendants regarding the ’287 Patent
2024-07-24 Complaint Filed

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

U.S. Patent No. 9,550,052 - “CONSOLE SYSTEM FOR THE TREATMENT OF SKIN”

The Invention Explained

  • Problem Addressed: The patent’s background section describes prior art skin abrasion techniques like dermabrasion and microdermabrasion as often being painful, messy, and removing moisture from the skin without a way to simultaneously apply moisturizing or therapeutic agents ('052 Patent, col. 1:26-61).
  • The Patented Solution: The invention is a comprehensive skin treatment system centered on a console that manages a multi-step procedure. The system uses a manifold connected to multiple containers of different treatment liquids, a handpiece to apply the liquids, and a vacuum to remove waste fluid and exfoliated skin simultaneously ('052 Patent, Abstract; col. 5:10-25). This configuration allows a user to select and deliver different treatment materials sequentially or simultaneously from a central console, enabling what is often called "hydrodermabrasion" ('052 Patent, col. 5:16-25).
  • Technical Importance: This integrated approach allows for a combined therapy of exfoliation, cleansing, and hydration in a single, controlled procedure, which contrasts with older methods that were harsher and required separate post-treatment application of moisturizers ('052 Patent, col. 1:52-61).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('052 Patent, Compl. ¶46).
  • Claim 1 of the ’052 Patent breaks down into the following essential elements:
    • A system for performing a skin treatment procedure, comprising:
    • [a] a console including a manifold, which is in fluid communication with at least a first and second fluid container holding a liquid treatment material;
    • [b] a handpiece assembly with a tip configured to contact skin;
    • [c] a supply conduit connecting the manifold to the handpiece;
    • [d] the manifold is configured to control the flow of treatment material from the containers through the supply conduit;
    • [e] a vacuum source;
    • [f] a waste conduit in fluid communication with the tip, operatively coupled to the vacuum source;
    • [g] a user-selectable control to choose which treatment material is delivered to the handpiece; and
    • [h] a functional requirement that when the vacuum is active and the tip contacts skin, a suction force is created that removes waste while simultaneously drawing treatment material from the containers to the tip.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,357,641 - “TIPS FOR SKIN TREATMENT DEVICE”

The Invention Explained

  • Problem Addressed: The patent addresses the need for a more effective handpiece tip that can simultaneously perform mechanical exfoliation while delivering and removing treatment fluids, improving on simpler fluid-delivery or abrasive-only tips (’641 Patent, col. 1:28-44).
  • The Patented Solution: The invention is a specially designed removable tip for a skin treatment handpiece. The core of the invention is the tip's surface geometry, which features an "outer member" to form a seal against the skin and at least one "inner member" arranged in a "spiral-like pattern." This spiral inner member is configured to abrade the skin, while separate internal passages deliver treatment fluid to the tip and use suction to remove the fluid along with exfoliated debris ('641 Patent, Abstract; col. 2:25-42). Figure 6B of the patent illustrates this spiral design ('641 Patent, Fig. 6B).
  • Technical Importance: This design integrates mechanical abrasion directly into the hydro-treatment process at the point of contact, allowing for a more efficient and effective combination of physical exfoliation and liquid-based cleansing and infusion ('641 Patent, col. 9:48-58).

Key Claims at a Glance

  • The complaint asserts independent claim 1 ('641 Patent, Compl. ¶57).
  • Claim 1 of the ’641 Patent breaks down into the following essential elements:
    • A tip configured for use in a skin treatment system, comprising:
    • [a] a tip body with a proximal end to couple to a handpiece and a distal end;
    • [b] at least one first passage through the tip body to deliver fluid to the distal end;
    • [c] at least one second passage through the tip body to convey fluid and debris away from the distal end;
    • [d] an outer member at the distal end defining a periphery for contacting skin;
    • [e] at least one inner member located inside the outer member, comprising a spiral-like pattern; and
    • [f] the inner member is configured to abrade skin.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,357,642 - “REMOVABLE TIPS FOR USE WITH SKIN TREATMENT SYSTEMS”

  • Technology Synopsis: This patent claims a removable tip for a skin treatment system that is "monolithically formed," meaning it is constructed as a single, solid piece. The tip includes a body, a vacuum hole, an outer member, and at least one inner member with a spiral-like pattern that is configured to abrade the skin (’642 Patent, Abstract; Claim 1). The invention combines the specific functional geometry of the spiral tip with the manufacturing method of monolithic formation.
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶68).
  • Accused Features: The complaint alleges that the Defendants' "AquaB" tips are single-piece, removable tips that embody the claimed structure, including the spiral-like abrading inner member (Compl. ¶68).

U.S. Patent No. 11,446,477 - “DEVICES AND METHODS FOR TREATING SKIN”

  • Technology Synopsis: This patent describes a skin treatment system featuring a console-based "manifold system" connected to multiple fluid containers. The invention focuses on the functional role of the vacuum source, which is configured to create a suction force that not only removes waste from the handpiece's working end but also helps "transfer treatment material from the manifold system to the handpiece assembly" (’477 Patent, Abstract; Claim 1).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶79).
  • Accused Features: The complaint alleges the Préime system’s vacuum source infringes by performing the dual functions of removing waste and assisting in the drawing of treatment fluid from the console's containers to the handpiece (Compl. ¶79).

U.S. Patent No. 11,865,287 - “DEVICES AND METHODS FOR TREATING SKIN”

  • Technology Synopsis: This patent claims a skin treatment system having a console with an internal "block" that fluidly connects to multiple containers. A key element is that the system is configured to deliver the different treatment fluids from the containers to the handpiece "sequentially" ('287 Patent, Abstract; Claim 1). This focuses on the system's ability to perform an ordered, multi-step treatment protocol.
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶90).
  • Accused Features: The Préime system is accused of infringing by having an internal fluid-handling block (manifold) and being configured to deliver different treatment fluids from its containers to the handpiece in a sequential manner, as allegedly instructed by user training and device software (Compl. ¶¶90, 55).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the "Préime system," which is a hydrodermabrasion device, and its associated, detachable "AquaB" tips (Compl. ¶¶25, 30).

Functionality and Market Context

  • The complaint describes the Préime system as a competing hydrodermabrasion device sold in the United States to dermatologists, plastic surgeons, and medical spas (Compl. ¶¶24-25). The system consists of a console that houses a manifold and multiple containers for skin treatment solutions, a handpiece, and detachable tips (Compl. ¶¶30, 32). An image in the complaint shows the system console with an internal manifold connected to four fluid containers (Compl. ¶32, image at p. 9). The system uses a vacuum source to suction waste and debris from the skin through the tip (Compl. ¶32). A user can control the selection of solutions, fluid flow, and vacuum level via a touchscreen interface on the console (Compl. ¶33, image at p. 10). The accused "AquaB" tips are made of hard plastic and feature a working surface with raised patterns designed to exfoliate the skin while fluid is delivered and suctioned away through various openings (Compl. ¶31).

IV. Analysis of Infringement Allegations

'052 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
[a] a console including a manifold, The Préime System comprises a console that internally includes a manifold for fluid management. ¶46 (p. 12-13) col. 5:10-15
[a][i] the manifold being in fluid communication with a first fluid container and at least a second fluid container The manifold is in fluid communication with at least two fluid containers that hold treatment solutions. ¶46 (p. 13-14) col. 5:16-20
[a][ii] the first fluid container and the at the second fluid container being configured to contain a treatment material for a skin treatment procedure, wherein the treatment material comprises a liquid; The fluid containers are configured to hold liquid skincare solutions, referred to as "DermaCeuticals." ¶46 (p. 14) col. 5:16-20
[b] a handpiece assembly comprising a tip, the tip being configured to contact a skin surface of a subject; The system includes a handpiece assembly with a detachable tip (the "AquaB" tip) designed to contact the patient's skin. ¶46 (p. 15-16) col. 6:35-37
[c] a supply conduit placing the manifold of the console in fluid communication with the handpiece assembly... The system includes internal tubing (supply conduit) that connects the manifold within the console to the handpiece assembly. ¶46 (p. 16-17) col. 5:10-15
[d] wherein the manifold is configured to control a flow of treatment material from the first fluid container and at least the second fluid container through a supply conduit; The system's touchscreen allows a user to select a fluid container and control the flow of fluid from that container to the handpiece. ¶46 (p. 17-18) col. 5:16-20
[e] a vacuum source; The Préime system brochure states that the handpiece merges "high-tech spiral movement with vacuum technology." ¶46 (p. 18) col. 8:36-40
[f] a waste conduit in fluid communication with the tip of the handpiece assembly to remove waste away from a skin surface... The system uses "spiral vacuum + specific solutions" to draw spent fluid and waste away from the skin through a waste conduit in the handpiece. ¶46 (p. 18-19) col. 8:41-47
[g] wherein the system is configured to permit a user to select the treatment material from the first fluid container or the at least second fluid container to be delivered... The system's touchscreen interface includes buttons that permit a user to select which fluid container to use for treatment. ¶46 (p. 19-20) col. 5:16-20
[h] wherein, when the vacuum source is activated and the tip contacts the skin surface, a suction force is created... thereby removing waste... while drawing treatment material... The vacuum suction creates a force that removes waste from the skin via the waste conduit while simultaneously drawing treatment solutions from the containers to the tip via the supply conduit. ¶46 (p. 20-21) col. 8:36-52
  • Identified Points of Contention:
    • Structural Questions: Does the accused Préime system contain a "manifold" that meets the structural and functional definition of that term in the patent? The complaint identifies an "internal" component as the manifold, and the precise nature and operation of this component relative to the patent's disclosure may be a central point of dispute (Compl. ¶32, image at p. 9).
    • Functional Questions: What is the exact function of the "Flow Control" option shown on the accused system's user interface (Compl. ¶46, image at p. 18)? The infringement allegation hinges on this feature meeting limitation [d] ("control a flow of treatment material"). A potential dispute is whether this control adjusts the rate of fluid delivery, as contemplated by the patent, or if it modifies another parameter, such as vacuum intensity.

'641 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
[a] a tip body extending from a proximal end to a distal end of the tip, the proximal end being configured to couple to a handpiece assembly; Each accused AquaB tip has a body with a proximal end that attaches to the Préime handpiece and a distal end that contacts the skin. ¶57 (p. 24) col. 9:59-64
[b] at least one first passage extending through an interior of the tip body and configured to receive a fluid and to deliver said fluid to the distal end of the tip; The tips have at least one internal passage to deliver skincare solutions from the handpiece to the tip's distal end for application to the skin. ¶57 (p. 24) col. 8:31-35
[c] at least one second passage extending through an interior of the tip body and configured to convey fluid and debris away from the distal end of the tip. The tips use "spiral vacuum" to draw away spent fluid and debris from the skin surface through at least one internal waste passage. ¶57 (p. 25) col. 8:41-47
[d] an outer member defining a periphery along the distal end, the outer member being configured to contact skin during a treatment procedure; The tip has an outer rim that defines its periphery and is the part that makes initial contact with the skin to form a treatment area. ¶57 (p. 25-26) col. 10:33-37
[e] at least one inner member located within an inner area of the outer member, wherein the at least one inner member comprises a spiral-like pattern; Located within the outer rim, the tip has raised surfaces forming what is alleged to be a spiral-like pattern. An overhead image of the tip is provided as evidence (Compl. ¶57, image at p. 27). ¶57 (p. 26) col. 10:50-54
[f] wherein the at least one inner member is configured to abrade skin. The raised inner surfaces are alleged to be sharp enough to perform "cleans[ing] and gentle exfoliation," which constitutes abrasion of the skin. ¶57 (p. 27) col. 10:48-58
  • Identified Points of Contention:
    • Scope Questions: Does the pattern on the accused AquaB tip qualify as "spiral-like" under the proper construction of that term? The complaint provides a visual that appears to show a spiral pattern (Compl. ¶57, p. 27), but the exact geometry and whether it meets the claim's scope will likely be debated.
    • Technical Questions: What evidence demonstrates that the inner member of the AquaB tip is "configured to abrade skin"? The complaint alleges the product provides "gentle exfoliation" (Compl. ¶57, p. 27). The dispute may turn on whether this functionality rises to the level of "abrasion" as understood in the patent, which may require a certain degree of sharpness, material hardness, or intended mechanical action against the skin.

V. Key Claim Terms for Construction

  • For the ’052 Patent:

    • The Term: "manifold"
    • Context and Importance: This term is the central component of the claimed system architecture, responsible for managing multiple fluid sources. Its definition is critical because infringement depends on the accused system's internal fluid routing block meeting this definition. Practitioners may focus on this term because the accused "manifold" is an internal, unseen component whose structure and function must be mapped to the claim language (Compl. ¶32, image at p. 9).
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the manifold system in functional terms as something that "can control the flow of treatment material from containers" based on user selection, which could support a broad, function-driven definition ('052 Patent, col. 5:16-20).
      • Evidence for a Narrower Interpretation: The patent provides detailed drawings of a specific manifold embodiment with quick-release locks and a particular slide structure, which could be used to argue for a narrower construction limited to structures similar to those explicitly disclosed ('052 Patent, Figs. 15A-15E; col. 9:22-60).

  • For the ’641 Patent:

    • The Term: "spiral-like pattern"
    • Context and Importance: This term defines the core inventive feature of the claimed tip. The infringement case for this patent hinges on whether the accused tip's surface geometry falls within the scope of this term.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term "spiral-like" suggests that the pattern does not need to be a perfect mathematical spiral, potentially covering a range of generally curving patterns that radiate from a central point. The specification describes the inner member extending "from near the through-hole 122 towards at least one of the through-holes 114," describing a path rather than a strict shape ('641 Patent, col. 10:27-29).
      • Evidence for a Narrower Interpretation: The patent figures consistently depict a clear, continuous spiral shape (e.g., Fig. 6B). A defendant could argue that "spiral-like" requires, at a minimum, the continuous, curving, and radiating properties shown in the preferred embodiments ('641 Patent, Fig. 6B).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for all five patents. Inducement is based on allegations that Defendants provide instructional videos, user manuals, training, and demonstrations that actively encourage customers to assemble and use the Préime system in an infringing manner (Compl. ¶¶47, 58, 69, 80, 91). Contributory infringement is based on allegations that Defendants sell the Préime system and AquaB tips knowing they are especially made for use in an infringing manner and are not staple articles of commerce suitable for substantial non-infringing use (Compl. ¶¶49, 60, 71, 82, 93).
  • Willful Infringement: Willfulness is alleged for all five patents. The basis is alleged pre-suit and post-suit knowledge of the patents and infringement. The complaint asserts that Defendants, as competitors, knew or should have known of Plaintiff's patent portfolio, pointing to public patent markings on Plaintiff's website since at least June 2018 (Compl. ¶38). More directly, the complaint alleges Defendants received actual notice of infringement via letters dated October 10, 2023, and July 19, 2024 (Compl. ¶39).

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

  • A core issue will be one of structural correspondence: does the accused Préime system's internal fluid handling architecture, which the complaint labels a "manifold" or "block," possess the specific structures and perform the fluid selection, control, and vacuum-assisted transfer functions required by the asserted system patent claims, or is there a fundamental mismatch in its technical design and operation?
  • A second central question will be one of definitional scope: can the "pattern of raised surfaces" on the accused AquaB tip be construed as a "spiral-like pattern" that is "configured to abrade skin," as the tip patent claims require, or do these features represent a different, non-infringing structure whose primary function is something other than abrasion, such as fluid management or massage?
  • A key evidentiary question for willfulness will be timing and sufficiency of knowledge: what was the extent of Defendants' knowledge of the asserted patents, and when was that knowledge acquired? The analysis will likely focus on the effect of the October 2023 and July 2024 notice letters, as well as whether the allegation of constructive knowledge via Plaintiff's website is sufficient to establish pre-suit knowledge for conduct preceding the letters.