DCT

1:23-cv-00222

Serendia LLC v. Cutera Inc

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00222, D. Del., 03/01/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware based on Defendant's incorporation in that state.
  • Core Dispute: Plaintiff alleges that Defendant’s radio frequency (RF) microneedling devices infringe six patents related to dermatological treatment methods and apparatuses.
  • Technical Context: The technology involves using arrays of microneedles to deliver RF energy directly into the skin's dermal layer for aesthetic treatments, such as skin tightening and wrinkle reduction.
  • Key Procedural History: The complaint notes that a parallel complaint was filed at the International Trade Commission (ITC), which may result in a faster-track investigation focused on importation of the accused products.

Case Timeline

Date Event
2008-08-06 Earliest Priority Date ('536', '774', '812' Patents)
2011-06-14 Earliest Priority Date ('836', '379', '444' Patents)
2016-04-26 U.S. Patent No. 9,320,536 Issues
2016-11-01 U.S. Patent No. 9,480,836 Issues
2017-10-03 U.S. Patent No. 9,775,774 Issues
2018-08-28 U.S. Patent No. 10,058,379 Issues
2020-12-22 U.S. Patent No. 10,869,812 Issues
2022-08-09 U.S. Patent No. 11,406,444 Issues
2023-03-01 Complaint Filed

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

U.S. Patent No. 9,320,536 - Method, System, and Apparatus for Dermatological Treatment

  • Patent Identification: U.S. Patent No. 9,320,536, "Method, System, and Apparatus for Dermatological Treatment," issued April 26, 2016 (Compl. ¶9).

The Invention Explained

  • Problem Addressed: The patent family addresses limitations of prior art skin treatments, which either failed to effectively deliver energy to the dermal layer from the skin's surface or, when using needles, caused undesirable side effects like burning and scarring between the needles (’812 Patent, col. 1:60-68).
  • The Patented Solution: The invention is a system comprising a user-holdable device (handpiece) and a "releasably couplable deployable needle module" (disposable cartridge). The system features a motor to precisely extend the microneedles to a desired depth within the skin and a signal generator to apply therapeutic energy through those needles, while providing a specific mechanism for the electrical connection between the handpiece and disposable cartridge (’536 Patent, Abstract; ’812 Patent, col. 11:1-12:65, Figs. 9C-10F).
  • Technical Importance: This system architecture allows for the controlled and repeatable application of energy directly to the dermal tissue while using disposable components for sterility and convenience (Compl. ¶23).

Key Claims at a Glance

  • The complaint asserts the independent claims of the ’536 Patent (Compl. ¶29). Independent claim 1 includes the following essential elements:
    • Placing a "user holdable device releasably couplable deployable needle assembly end surface" near tissue.
    • The device includes a proximal end (handpiece) and the mechanically separable needle assembly.
    • The needle assembly contains a "plurality of needles extendable" from its surface.
    • An electrical connection is made via at least one "restorably deflectable electrical contact."
    • A motor is energized to extend the needles a desired distance.
    • A signal generator is used to energize the extended needles.

U.S. Patent No. 9,480,836 - Skin Treatment Apparatus and Method

  • Patent Identification: U.S. Patent No. 9,480,836, "Skin Treatment Apparatus and Method," issued November 1, 2016 (Compl. ¶11).

The Invention Explained

  • Problem Addressed: The patent family identifies issues with prior art RF needle devices, including those that create excessive heat and burning in the epidermis between the needles, and monopole devices that require high voltages with systemic risks (’379 Patent, col. 2:14-35).
  • The Patented Solution: The invention discloses using a plurality of bipolar electrodes (needles) with an alternating current (AC) RF signal. By controlling parameters such as frequency and needle spacing, the system is configured to cause tissue coagulation in an area around each individual electrode rather than in the tissue between the electrodes, thereby focusing the therapeutic effect in the dermis while sparing the epidermis (’836 Patent, Claim 1; ’379 Patent, Abstract, Fig. 5). The complaint refers to this as the "Na effect" (Compl. ¶21).
  • Technical Importance: This method allows for targeted thermal treatment of the dermis to stimulate collagen regeneration while minimizing damage to the outer skin layer, which may lead to reduced pain and faster recovery (Compl. ¶21).

Key Claims at a Glance

  • The complaint asserts the independent claims of the ’836 Patent (Compl. ¶40). Independent claim 1 includes the following essential elements:
    • A plurality of electrodes that are bipolar and insertable into skin.
    • An RF generation module coupled to the electrodes.
    • The module is configured to provide an Alternating Current (AC) RF signal to the electrodes.
    • The signal is configured to "cause coagulation around each electrode rather than coagulating between the electrodes."

U.S. Patent No. 9,775,774 - Method, System, and Apparatus for Dermatological Treatment

  • Patent Identification: U.S. Patent No. 9,775,774, "Method, System, and Apparatus for Dermatological Treatment," issued October 3, 2017 (Compl. ¶13).
  • Technology Synopsis: Belonging to the same family as the ’536 Patent, this patent relates to systems and methods for dermatological treatment using an apparatus with extendable needles to deliver energy into the skin, focusing on the controlled application and apparatus structure.
  • Asserted Claims: Independent claims are asserted (Compl. ¶51).
  • Accused Features: The Secret RF and Secret Pro devices are accused of infringing by their use of microneedles to deliver RF energy in a manner covered by the patent's claims (Compl. ¶¶ 24, 50).

U.S. Patent No. 10,058,379 - Electrically Based Medical Treatment Device and Method

  • Patent Identification: U.S. Patent No. 10,058,379, "Electrically Based Medical Treatment Device and Method," issued August 28, 2018 (Compl. ¶15).
  • Technology Synopsis: Belonging to the same family as the ’836 Patent, this patent concerns a device using multiple bipolar microneedle electrodes and an oscillating RF signal to create distinct coagulation zones around each individual needle, thereby avoiding epidermal burning between the needles.
  • Asserted Claims: Independent claims are asserted (Compl. ¶62).
  • Accused Features: The Secret RF and Secret Pro devices are accused of infringing by their method of using RF microneedling to treat skin (Compl. ¶¶ 24, 61).

U.S. Patent No. 10,869,812 - Method, System, and Apparatus for Dermatological Treatment

  • Patent Identification: U.S. Patent No. 10,869,812, "Method, System, and Apparatus for Dermatological Treatment," issued December 22, 2020 (Compl. ¶17).
  • Technology Synopsis: As a member of the ’536 Patent family, this patent covers systems for dermatological treatment that include a user-holdable device with a releasably couplable, deployable needle module for the controlled delivery of energy to skin tissue.
  • Asserted Claims: Independent claims are asserted (Compl. ¶73).
  • Accused Features: The overall system architecture and operation of the Secret RF and Secret Pro products are accused of infringement (Compl. ¶¶ 24, 72).

U.S. Patent No. 11,406,444 - Electrically Based Medical Treatment Device and Method

  • Patent Identification: U.S. Patent No. 11,406,444, "Electrically Based Medical Treatment Device and Method," issued August 9, 2022 (Compl. ¶19).
  • Technology Synopsis: As a member of the ’836 Patent family, this patent claims a medical device that utilizes bipolar microneedle electrodes and an oscillating RF current to apply energy substantially around each individual electrode, rather than between them, for aesthetic skin treatment.
  • Asserted Claims: Independent claims are asserted (Compl. ¶84).
  • Accused Features: The Secret RF and Secret Pro devices' method of applying RF energy via microneedles is accused of infringement (Compl. ¶¶ 24, 83).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant Cutera's "Secret RF and Secret Pro" devices and their components, such as needle assemblies (Compl. ¶24).

Functionality and Market Context

  • The complaint identifies the accused products as "RF microneedling dermatological treatment devices" (Compl. ¶24). Plaintiff Serendia alleges that it is an operating company that markets a competing product, the Scarlet SRF device, and therefore competes with Cutera in the market for such systems (Compl. ¶¶ 25-26). The complaint further alleges that the design, manufacture, and sale of these products is a primary aspect of Cutera's business (Compl. ¶24). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges infringement of all six patents-in-suit and states that claim charts applying the independent claims of the patents to the accused products are provided in Exhibits 8 through 19 (Compl. ¶¶ 29, 40, 51, 62, 73, 84). As these exhibits were not attached to the publicly filed complaint, a detailed element-by-element analysis of the infringement allegations is not possible from the document provided. The narrative infringement theory is based on the general operation of the accused Secret RF and Secret Pro devices as RF microneedling systems.

  • '536 Patent Family Infringement Theory: The infringement theory for the ’536, ’774, and ’812 patents appears to be based on the overall system architecture of the accused products. This includes the use of a handpiece coupled to a disposable, motor-driven, deployable needle cartridge that is electrically connected to the handpiece to receive and deliver RF energy (Compl. ¶¶ 28, 50, 72).
  • '836 Patent Family Infringement Theory: The infringement theory for the ’836, ’379, and ’444 patents appears to be based on the specific method of action of the accused products. The complaint alleges that the inventor, Dr. Na, pioneered an approach where RF energy is concentrated around each individual electrode to cause coagulation, an effect the complaint terms the "Na effect" (Compl. ¶21). The infringement allegation suggests that the accused products operate in this manner (Compl. ¶¶ 39, 61, 83).

Identified Points of Contention

  • ’536 Patent Family: A potential point of contention may be the structural and functional correspondence between the accused devices' components and the specific claim limitations. For example, the case may involve disputes over whether the mechanism connecting the accused handpiece and needle cartridge meets the definition of a "restorably deflectable electrical contact" as recited in claim 1 of the ’536 Patent.
  • ’836 Patent Family: The central point of contention for this patent family will likely be a highly technical and factual question of physics: do the accused products actually generate an electrical field that causes coagulation "around each electrode rather than coagulating between the electrodes"? This determination may depend on factors like the frequency of the RF signal, the spacing and configuration of the needles, and the operational parameters of the accused devices, likely requiring extensive expert analysis and testing.

V. Key Claim Terms for Construction

Term: "restorably deflectable electrical contact"

(from claim 1 of the ’536 Patent)

  • Context and Importance: This term defines the nature of the electrical and mechanical connection between the reusable handpiece and the disposable needle cartridge. The scope of this term will be critical for determining whether the specific connector design of the accused products infringes.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language does not specify a particular structure or material for the contact, which may support a construction covering any contact that is capable of being deflected and returning to its original position to make an electrical connection.
    • Evidence for a Narrower Interpretation: The specification of the related ’812 Patent discloses a specific embodiment with locking arms and tabs that deflect and engage recesses (e.g., ’812 Patent, Figs. 10A-10F, col. 11:5-12:51). A defendant may argue that the term should be construed more narrowly in light of these specific disclosed structures.

Term: "coagulation around each electrode rather than coagulating between the electrodes"

(from claim 1 of the ’836 Patent)

  • Context and Importance: This phrase captures the core of the purported invention of the ’836 patent family—the "Na effect." The outcome of the infringement analysis for these patents will likely depend entirely on how this functional limitation is construed and whether the accused products meet it.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The language is functional, describing a result. A plaintiff may argue that any device achieving this result infringes, irrespective of the precise mechanism or operating parameters.
    • Evidence for a Narrower Interpretation: The specification of the related ’379 Patent contrasts this effect (shown in Fig. 5) with prior art coagulation between needles (shown in Fig. 3) and links the inventive effect to specific operating parameters, such as using an AC frequency above 0.5 MHz (’379 Patent, col. 6:46-53). A defendant may argue that the claim should be limited to devices that operate using the principles disclosed as necessary to achieve this distinct result.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. Inducement is based on allegations that Cutera provides "demonstrative and informational webinars, videos, and other materials" instructing customers on how to use the products in an infringing manner (Compl. ¶¶ 31-33). Contributory infringement is based on allegations that the accused products are material components specifically made for infringing use and are not staple articles of commerce (Compl. ¶34).
  • Willful Infringement: The complaint alleges that Cutera has had knowledge of the asserted patents and its infringement no later than the filing date of the complaint and the parallel ITC complaint (Compl. ¶30). This allegation forms the basis for willfulness based on post-suit conduct.

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

  1. A central issue will be one of physical effect: Do the accused Secret RF and Secret Pro devices operate in a manner that creates coagulation zones primarily around each individual microneedle, as claimed in the '836 patent family, or do they create a more diffuse heating effect between the needles, characteristic of prior art? The answer will likely require detailed expert testimony and empirical evidence regarding the biophysics of RF energy delivery into tissue.
  2. The case will also present a question of structural equivalence: Does the mechanism used to connect the disposable needle cartridges to the handpieces in the accused products meet the specific claim limitations of the '536 patent family, particularly the term "restorably deflectable electrical contact," or does it represent a non-infringing alternative design?
  3. A significant procedural question will be the impact of the parallel ITC investigation: How will the discovery, claim construction (Markman) process, and potential issuance of an exclusion order in the faster-paced ITC forum influence the strategy, timing, and potential settlement dynamics of this district court case?