DCT

1:23-cv-00224

Serendia LLC v. EndyMed Medical Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-00224, D. Del., 03/01/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s "Intensif" line of radio frequency (RF) microneedling products infringes six patents related to systems and methods for dermatological treatment.
  • Technical Context: The technology at issue is radio frequency microneedling, an aesthetic medical procedure that uses fine needles to deliver RF energy into the dermis to stimulate collagen production and tighten the skin.
  • Key Procedural History: The complaint alleges that Defendant gained knowledge of the patents-in-suit no later than the filing of this complaint and a "parallel complaint filed at the International Trade Commission," indicating a concurrent ITC investigation.

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”

  • The Invention Explained:
    • Problem Addressed: The patent addresses shortcomings in prior art skin treatments, such as the ineffectiveness of applying radio frequency (RF) energy non-invasively to the skin's surface and the potential for epidermal burning and scarring when using older RF needle-based methods (’812 Patent, col. 1:49-col. 2:35).
    • The Patented Solution: The invention provides a system comprising a hand-held device and a releasably couplable, disposable needle cartridge (’812 Patent, col. 11:5-10). A motor within the handpiece mechanically deploys the plurality of needles to a precise, user-selected depth within the skin, and a signal generator delivers electrical energy through the needles to treat the targeted dermal tissue with various operational modes, such as "cut, blend, and coagulation" (’536 Patent, Abstract; ’812 Patent, col. 13:48-50).
    • Technical Importance: This approach allows for the controlled delivery of therapeutic energy directly into the dermis while minimizing damage to the outer layer of skin (epidermis), thereby improving treatment outcomes and reducing recovery time (Compl. ¶23).
  • Key Claims at a Glance:
    • The complaint refers to claim charts for the "independent claims," which were not attached as exhibits (Compl. ¶29). Representative independent apparatus claim 11 requires:
      • A user holdable device with a proximal end and a releasably couplable deployable needle assembly.
      • The needle assembly is mechanically separable from the proximal end and includes a plurality of extendable needles.
      • The assembly includes at least one electrical conductor and at least one "restorably deflectable electrical contact."
      • A motor coupled to the needles to extend them a desired distance.
      • A signal generator electrically coupled to the needles to energize them.

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

  • The Invention Explained:
    • Problem Addressed: The patent identifies issues with prior RF needle technologies, including the risk of burns to the epidermis located between the needles and side effects from insulated needles, such as insulation failure or increased pain from thicker needles (’379 Patent, col. 2:14-29).
    • The Patented Solution: The invention discloses a method and apparatus using bipolar needles and an alternating current (AC) RF signal to generate a distinct, localized energy field primarily around the tip of each individual needle within the dermis (’379 Patent, Abstract; ’379 Patent, col. 4:56-64). This localized coagulation, which the complaint terms the "Na effect," is designed to avoid creating a significant electrical field and subsequent heating in the tissue between the needles, thereby protecting the epidermis (Compl. ¶21; ’379 Patent, Fig. 5).
    • Technical Importance: This method purports to achieve the desired skin tightening through precise coagulation in the dermis while substantially reducing the risk of surface-level burns and scarring that could occur if energy were passed between the needles through the epidermis (Compl. ¶21, ¶23).
  • Key Claims at a Glance:
    • The complaint refers to claim charts for the "independent claims," which were not attached as exhibits (Compl. ¶40). Representative independent apparatus claim 1 of the related ’379 Patent requires:
      • A plurality of bipolar electrodes configured to be inserted into a body segment.
      • A radio frequency (RF) generation module electrically coupled to the electrodes.
      • The module is configured to provide an RF signal with oscillating current to the electrodes to "apply energy to body segments around each electrode rather than to body segments between the electrodes."

Multi-Patent Capsule: U.S. Patent No. 9,775,774

  • Patent Identification: U.S. Patent No. 9775774, “Method, System, and Apparatus for Dermatological Treatment,” issued October 3, 2017.
  • Technology Synopsis: Belonging to the same family as the ’536 Patent, this patent relates to a dermatological treatment apparatus with a handpiece and a disposable needle cartridge. The system is designed to mechanically deploy needles to a specific depth and deliver therapeutic energy.
  • Asserted Claims: Independent claims are asserted (Compl. ¶51).
  • Accused Features: The complaint accuses the EndyMed Intensif products, which allegedly utilize a handpiece and disposable needle cartridges to perform RF microneedling treatments (Compl. ¶24, ¶50).

Multi-Patent Capsule: U.S. Patent No. 10,058,379

  • Patent Identification: U.S. Patent No. 10058379, “Electrically Based Medical Treatment Device and Method,” issued August 28, 2018.
  • Technology Synopsis: A member of the same family as the ’836 Patent, this patent focuses on an RF microneedling technology that generates a localized energy field around each needle tip. This "Na effect" is intended to cause coagulation in the dermis while protecting the epidermis from thermal damage.
  • Asserted Claims: Independent claims are asserted (Compl. ¶62).
  • Accused Features: The complaint targets the Intensif products for allegedly using bipolar needles and an RF generator to create the claimed localized energy effect around each needle (Compl. ¶24, ¶61).

Multi-Patent Capsule: U.S. Patent No. 10,869,812

  • Patent Identification: U.S. Patent No. 10869812, “Method, System, and Apparatus for Dermatological Treatment,” issued December 22, 2020.
  • Technology Synopsis: As a member of the ’536 patent family, this patent concerns a dermatological treatment system with a user-holdable device and a mechanically deployable, disposable needle cartridge for delivering energy into the skin.
  • Asserted Claims: Independent claims are asserted (Compl. ¶73).
  • Accused Features: The infringement allegations are directed at the EndyMed Intensif system’s handpiece and disposable needle components used for RF skin treatments (Compl. ¶24, ¶72).

Multi-Patent Capsule: U.S. Patent No. 11,406,444

  • Patent Identification: U.S. Patent No. 11406444, “Electrically Based Medical Treatment Device and Method,” issued August 9, 2022.
  • Technology Synopsis: Belonging to the ’836 patent family, this patent describes an RF microneedling device designed to produce the "Na effect," where energy is applied to create coagulation zones around each individual needle rather than between them, thus protecting the skin surface.
  • Asserted Claims: Independent claims are asserted (Compl. ¶84).
  • Accused Features: The complaint accuses the Intensif products of infringing by allegedly employing bipolar needles with an RF signal configured to generate the claimed localized coagulation effect (Compl. ¶24, ¶83).

III. The Accused Instrumentality

  • Product Identification: The accused products are EndyMed's "RF microneedling dermatological treatment devices and components thereof (e.g., needle assemblies), including the Intensif" (Compl. ¶24).
  • Functionality and Market Context: The complaint characterizes the accused products as systems used for aesthetic dermatological treatment for skin tightening (Compl. ¶22, ¶26). Plaintiff alleges that designing, manufacturing, and selling these devices is the primary nature of Defendant's business and that Defendant competes directly with Plaintiff in the market for RF microneedling systems (Compl. ¶24, ¶26). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint repeatedly references claim chart exhibits that were not filed with the public complaint (Compl. ¶29, ¶40, ¶51, ¶62, ¶73, ¶84). The narrative infringement theory is summarized below in prose.

  • '536 Patent Family Infringement Theory: The complaint alleges that the accused Intensif products meet the limitations of the ’536 patent family. The theory suggests that the Intensif system includes a hand-held device into which a disposable cartridge containing multiple needles is inserted. This system is alleged to use a motor or similar mechanism to mechanically deploy the needles into the skin and a signal generator to apply RF energy through those needles to treat dermal tissue (Compl. ¶23-¶24, ¶28).
  • '836 Patent Family Infringement Theory: The complaint alleges that the accused Intensif products practice the invention of the ’836 patent family. The core of this theory is that the Intensif device uses bipolar microneedles and an RF signal configured to produce the "Na effect"—a localized coagulation of tissue primarily around each individual needle tip rather than in the tissue between the needles. This allegedly achieves the patented method of treating the dermis while minimizing heat damage to the epidermis (Compl. ¶21, ¶23, ¶39).
  • Identified Points of Contention:
    • Scope Questions: A central question for the '836 patent family infringement analysis will be the interpretation of the phrase "apply energy to body segments around each electrode rather than to body segments between the electrodes" (’379 Patent, col. 14:55-57). The dispute may focus on the degree to which energy must be localized around each needle versus what level of energy dissipation between needles falls outside the claim scope. For the ’536 family, the construction of terms like "motor" and "drive module" may be disputed, particularly whether the accused product's deployment mechanism is structurally and functionally equivalent to that claimed (’812 Patent, col. 16:44-48).
    • Technical Questions: A key factual question will be where the accused Intensif device's RF energy is actually delivered and causes the most significant thermal effect. The case may require expert testimony and technical evidence (e.g., thermal imaging, tissue analysis) to determine if the device produces the localized "Na effect" as claimed, or if it operates more like prior art devices that heated the tissue between the needles. The specific operating parameters of the accused device, such as RF frequency and needle spacing, will be critical facts in this analysis (’379 Patent, col. 11:6-8; col. 12:65-67).

V. Key Claim Terms for Construction

  • The Term: "apply energy to body segments around each electrode rather than to body segments between the electrodes" (from claim 1 of the '379 Patent).
  • Context and Importance: This phrase is the central feature distinguishing the ’836 patent family from prior art. The outcome of the infringement analysis for three of the six asserted patents will likely depend on whether the accused product's function is found to meet this limitation. Practitioners may focus on this term because it presents a quantitative question—how much energy "around" versus "between" is required to infringe?
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the general principle that using bipolar needles with AC signals allows each needle to "independently form an energy field about its tip," suggesting the concept applies broadly to systems creating such independent fields (’379 Patent, col. 4:58-60).
    • Evidence for a Narrower Interpretation: The specification links the desired effect to specific operating parameters, such as an AC frequency of "about 2.0 MHz" and needle spacing of "about 2 mm apart," and provides figures like Fig. 5 illustrating distinct, non-overlapping oval-shaped heated areas around each needle (’379 Patent, col. 11:6-8; col. 12:65-67; Fig. 5). This may support an argument that the term requires operation that results in physically separate zones of coagulation.
  • The Term: "motor" (related to the '536 patent family).
  • Context and Importance: The claims of the ’536 family require a "motor" to deploy the needles. The infringement determination will depend on whether the mechanism used in the accused Intensif product falls within the legal scope of this term.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term is used generally in the specification to "controllably move one or more of the plurality of electrodes into a body segment," suggesting any electromechanical actuator performing this function could be covered (’812 Patent, col. 9:57-64).
    • Evidence for a Narrower Interpretation: The specification discloses a specific embodiment: "a transverse motor that converts rotational force to longitudinal force," and even provides a specific model number (’812 Patent, col. 14:5-11). This could be used to argue for a narrower construction limited to similar types of motors.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement, stating that EndyMed provides "demonstrative and informational webinars, videos, and other materials" that instruct and encourage customers to use the accused products in an infringing manner (Compl. ¶33, ¶44, ¶55, ¶66, ¶77, ¶88). Contributory infringement is also alleged on the basis that the accused products are specially made for an infringing use and have no substantial non-infringing uses (Compl. ¶34, ¶45, ¶56, ¶67, ¶78, ¶89).
  • Willful Infringement: Willfulness is pled based on EndyMed’s alleged knowledge of the asserted patents and their infringement "no later than the filing date of this complaint and the parallel complaint filed at the International Trade Commission" (Compl. ¶30, ¶41, ¶52, ¶63, ¶74, ¶85).

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

  • A central technical question will be one of functional locus: does the accused Intensif device's RF energy primarily cause coagulation around each individual needle tip (the "Na effect" claimed in the '836 patent family), or does significant coagulation occur between the needles, potentially placing its operation outside the claim scope and closer to the prior art the patents sought to improve upon?
  • A key claim construction and infringement issue for the '536 patent family will be one of mechanism scope: does the electromechanical system used in the Intensif device to advance and retract the needles meet the limitations of the claimed "motor" and "drive module," particularly in light of the specific embodiments and operational details disclosed in the patent specification?
  • A significant procedural factor will be the interplay with the parallel ITC investigation mentioned in the complaint. Evidence, claim construction rulings, and outcomes from the fast-paced ITC forum could substantially influence the strategy, pacing, and potential resolution of this district court litigation.