DCT

2:22-cv-00015

Serendia LLC v. Aesthetics Biomedical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:22-cv-00015, D. Ariz., 03/06/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Arizona because Defendant Aesthetics Biomedical, Inc. maintains its principal place of business in Phoenix, Arizona, within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Vivace microneedling device, a product for aesthetic skin treatment, infringes four patents related to methods and apparatuses for applying radio frequency energy to the skin.
  • Technical Context: The technology at issue involves radio frequency (RF) microneedling systems designed to deliver controlled thermal energy to the dermis layer of the skin to promote collagen regeneration and skin tightening for aesthetic purposes.
  • Key Procedural History: The complaint alleges that Defendant was made aware of its potential infringement of the '536 and '836 patents via a letter dated February 9, 2018, and was made aware of all four asserted patents via a follow-up letter dated April 23, 2021, establishing a basis for the willfulness allegations.

Case Timeline

Date Event
2008-08-06 Earliest Priority Date ('536, '812 Patents)
2011-06-14 Earliest Priority Date ('836, '379 Patents)
2016-04-26 Issue Date: U.S. Patent No. 9,320,536
2016-11-01 Issue Date: U.S. Patent No. 9,480,836
2018-02-09 Plaintiff sends letter to Defendant regarding '536 and '836 Patents
2018-08-28 Issue Date: U.S. Patent No. 10,058,379
2020-12-22 Issue Date: U.S. Patent No. 10,869,812
2021-04-23 Plaintiff sends follow-up letter to Defendant regarding all Asserted Patents
2023-03-06 Complaint Filing Date

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

U.S. Patent No. 9,320,536 - "Method, System, and Apparatus for Dermatological Treatment," Issued April 26, 2016

The Invention Explained

  • Problem Addressed: The patent describes prior art RF skin treatments as facing several problems: indirect energy delivery was inefficient, monopolar needles impacted unintended organs, and early bipolar microneedles caused significant burning and pain to the patient's epidermis (Compl. ¶¶11-13).
  • The Patented Solution: The invention proposes a dermatological treatment apparatus with a deployable needle module that uses a motor to precisely extend a plurality of needles into the skin. An RF signal generator then applies energy to these needles for a controlled duration, designed to treat the dermis while minimizing thermal damage to the surface epidermis (’536 Patent, col. 10:1-25; Fig. 9A-9D).
  • Technical Importance: This approach sought to improve the safety and efficacy of RF skin treatments by enabling precise, repeatable needle deployment and controlled energy delivery directly to the target dermal tissue (Compl. ¶14).

Key Claims at a Glance

  • The complaint asserts infringement of claims 11, 12, 14, 16, and 19 ('536 Patent, Compl. ¶21). Claim 11 is an independent apparatus claim.
  • Independent Claim 11:
    • a user holdable device including a proximal end and a releasably couplable deployable needle assembly,
    • the deployable needle assembly mechanically separatably from the proximal end and including a plurality of extendable needles,
    • one of the proximal end and the deployable needle assembly including at least one electrical conductor and the other including at least one restorably deflectable electrical contact,
    • a motor coupled to the plurality of extendable needles that causes the needles to extend a desired distance,
    • and a signal generator electrically coupled to the needles to energize them.
  • The complaint reserves the right to assert other claims, including dependent claims (Compl. ¶21).

U.S. Patent No. 9,480,836 - "Skin Treatment Apparatus and Method," Issued November 1, 2016

The Invention Explained

  • Problem Addressed: The patent identifies a need to improve upon existing RF skin treatments, which could be ineffective or cause undesirable side effects such as burning the epidermis when energy is delivered between needles (’836 Patent, col. 2:14-19).
  • The Patented Solution: The invention describes a skin treatment apparatus using bipolar electrodes (needles) that are energized with an Alternating Current (AC) RF signal. This configuration is designed to cause coagulation "around each electrode rather than coagulating between the electrodes," thereby focusing the therapeutic thermal effect in the dermis at the needle tip location while sparing the epidermis (’836 Patent, Abstract; col. 4:11-17). This is illustrated in Figure 5, which shows distinct, oval-shaped heated areas (909) around each needle tip.
  • Technical Importance: By creating a thermal effect localized around individual needles rather than across the space between them, the invention aimed to provide effective dermal treatment with reduced risk of surface-level skin damage (Compl. ¶14).

Key Claims at a Glance

  • The complaint asserts infringement of claims 1, 2, 3, 4, 6, 7, 8, 9, and 12 ('836 Patent, Compl. ¶34). Claim 1 is an independent apparatus claim.
  • Independent Claim 1:
    • a plurality of electrodes, the electrodes being bipolar and configured to be insertable into skin,
    • a radio frequency (RF) generation module electrically coupled to the electrodes,
    • the module configured to provide an Alternating Current (AC) RF signal to the electrodes,
    • configured to cause coagulation around each electrode rather than coagulating between the electrodes.
  • The complaint reserves the right to assert other claims (Compl. ¶34).

U.S. Patent No. 10,058,379 - "Electrically Based Medical Treatment Device and Method," Issued August 28, 2018

  • Technology Synopsis: This patent, a continuation of the '836 patent, further details a medical treatment device using a plurality of bipolar electrodes. It emphasizes applying an RF signal with oscillating current to generate an energy field "around each electrode rather than to body segments between the electrodes" to revitalize and regenerate collagen in the dermis while preventing overheating of the epidermis (’379 Patent, Abstract; col. 4:8-17).
  • Asserted Claims: Claims 1, 2, 3, 4, 6, and 8 are asserted, with Claim 1 being an independent apparatus claim (Compl. ¶47).
  • Accused Features: The complaint alleges that Defendant's Vivace microneedling devices infringe the '379 patent (Compl. ¶46).

U.S. Patent No. 10,869,812 - "Method, System, and Apparatus for Dermatological Treatment," Issued December 22, 2020

  • Technology Synopsis: This patent, which shares a priority claim with the '536 patent, describes a dermatological treatment apparatus having a user-holdable device and a releasably couplable, deployable needle module. The system uses a motor to precisely deploy the needles and an electrical signal generator to provide energy, and may include features like embedded LEDs for light therapy (’812 Patent, Abstract; col. 10:5-14).
  • Asserted Claims: Claims 12, 13, 14, 15, 16, 17, and 18 are asserted, with Claim 12 being an independent apparatus claim (Compl. ¶60).
  • Accused Features: The complaint alleges that the Vivace microneedling device infringes the '812 patent (Compl. ¶59).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the "Vivace microneedling device" (Compl. ¶20, ¶33, ¶46, ¶59).
  • Functionality and Market Context: The complaint identifies the Vivace device as a radio frequency microneedling system used for medical and aesthetic dermatological treatment for tightening skin (Compl. ¶16, ¶20). It is alleged to compete directly in the market with Plaintiff Serendia's own "Scarlet SRF" device (Compl. ¶15-16). The complaint alleges that the Vivace device performs the patented methods and embodies the patented apparatuses for applying RF energy to a patient's skin via microneedles (Compl. ¶20, ¶33). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

For each of the four asserted patents, the complaint alleges infringement but states that an "Exemplary infringement analysis" is set forth in an external exhibit (Compl. ¶21, ¶34, ¶47, ¶60, referring to Exhibits 1, 3, 4, and 5). These exhibits are not attached to the complaint provided for analysis. The complaint itself does not contain a narrative infringement theory or claim charts mapping specific product features to claim elements.

  • Identified Points of Contention:
    • Scope Questions: A central question for the '836 and '379 patents will be the interpretation of the phrase "around each electrode rather than... between the electrodes." The court will need to determine whether this requires the complete absence of an energy field between electrodes or merely that the primary therapeutic coagulation effect is localized at each individual needle tip.
    • Technical Questions: A key factual dispute will likely concern how the Vivace device actually operates at a microscopic level. Plaintiff will bear the burden of proving, through technical evidence and expert testimony, that the Vivace device's RF energy delivery mechanism creates the specific localized coagulation pattern claimed in the '836 and '379 patents, as opposed to a more diffuse or inter-electrode energy field characteristic of the prior art the patents sought to improve upon (’379 Patent, col. 4:8-17). For the '536 and '812 patents, a technical question may arise regarding whether the Vivace device's needle deployment mechanism and electrical contacts meet the specific structural limitations of the claims, such as the "restorably deflectable electrical contact" of '536 Patent claim 11.

V. Key Claim Terms for Construction

U.S. Patent No. 10,058,379

  • The Term: "apply energy to body segments around each electrode rather than to body segments between the electrodes" (from independent claim 1).
  • Context and Importance: This phrase appears to be the primary point of novelty, distinguishing the invention from prior art that allegedly heated the tissue between needles, causing unwanted epidermal burning. The entire infringement case for the '379 and '836 patents may depend on whether the Vivace device is found to operate in the manner described by this limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party arguing for a broader scope might point to the general description, suggesting the key is simply revitalizing collagen by "wounding the dermis" and that the phrase does not require zero energy transfer between electrodes, only that the primary therapeutic effect is localized (’379 Patent, col. 2:41-44).
    • Evidence for a Narrower Interpretation: A party arguing for a narrower scope could cite the patent’s repeated distinction from prior art that burns "both epidermis and dermis between the needles" (’379 Patent, col. 2:16-19). They may also point to Figure 5, which explicitly illustrates "non-overlapping or non-intersecting energy fields," showing distinct, tear-shaped heated areas (949) confined to the area immediately surrounding each needle tip as evidence that the claims require spatial separation of the energy fields.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement for all four patents. The stated basis for inducement is that Defendant actively aids and abets infringement by distributing the Vivace device and providing "live and on-demand informational symposiums and webinars" that instruct and encourage customers on its infringing use (Compl. ¶23-25, ¶36-38, ¶49-51, ¶62-64). The complaint also pleads contributory infringement, alleging the Vivace device is a material component especially made for infringing use and is not a staple article of commerce suitable for substantial non-infringing use (Compl. ¶26, ¶39, ¶52, ¶65).
  • Willful Infringement: The complaint alleges willful infringement for all four patents. The allegations are based on Defendant's alleged knowledge of the patents since at least February 9, 2018 (for the '536 and '836 patents) and April 23, 2021 (for all asserted patents) as a result of pre-suit notice letters sent by Plaintiff (Compl. ¶22, ¶27, ¶35, ¶40, ¶48, ¶53, ¶61, ¶66).

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

  1. Claim Scope and the "Around vs. Between" Distinction: A core issue will be one of claim construction: how will the court define the central limitation of applying energy "around each electrode rather than... between the electrodes"? The viability of the infringement claims for the '836 and '379 patents hinges on whether this phrase requires a complete absence of energy fields between needles—a high bar for proof—or if it describes a less absolute, primary mode of action.

  2. The Evidentiary Challenge of Microscopic Operation: A key question will be one of technical proof: what evidence can Plaintiff produce to demonstrate that the accused Vivace device, during operation, generates the specific, localized coagulation zones required by the claims? Conversely, what evidence can the Defendant show to suggest its device operates differently? This will likely involve a battle of competing expert analyses and technical testing of the accused device's biophysical effects on tissue.

  3. Willfulness and Pre-Suit Knowledge: Given the explicit allegations of pre-suit notice letters dating back to 2018, a central question will be one of intent: did the Defendant's alleged continued infringement after receiving notice constitute objective recklessness? The answer will depend on the timing and content of the communications, and any defenses or non-infringement positions Defendant may have developed in response to the notice.