DCT

1:19-cv-00100

Solta Medical Inc v. Sciton Inc

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00100, D. Del., 01/17/2019
  • Venue Allegations: Venue is asserted as proper in the District of Delaware because the Defendant, Sciton, Inc., is a Delaware corporation.
  • Core Dispute: Plaintiff alleges that Defendant’s HALO and ProFractional laser systems infringe two reissued patents related to methods for dermatological laser treatment that use a cooled, transparent element to protect the skin’s surface.
  • Technical Context: The technology is in the field of aesthetic medicine, specifically laser skin resurfacing to treat conditions like wrinkles, sun damage, and scars.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with notice of infringement via a letter on or about July 14, 2016. Both asserted patents expired on October 16, 2018, meaning this lawsuit is for past monetary damages only.

Case Timeline

Date Event
1998-10-16 Earliest Priority Date ('594 & '881 Patents)
2011-08-02 U.S. Patent No. RE42,594 Issues
2012-12-25 U.S. Patent No. RE43,881 Issues
2014-01-01 Accused HALO Product Launched
2016-01-01 Accused ProFractional Product Launched
2016-07-14 Plaintiff Alleges Notifying Defendant of Infringement
2018-10-16 '594 and '881 Patents Expire
2019-01-17 Complaint Filed

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

U.S. Reissue Patent No. RE42,594

  • Patent Identification: U.S. Reissue Patent No. RE42,594, “Tissue Cooling Rod for Laser Surgery,” issued August 2, 2011.

The Invention Explained

  • Problem Addressed: The patent describes a challenge in laser skin surgery where laser energy intended for subsurface targets (e.g., blood vessels, collagen) can cause unwanted thermal damage to the skin's surface (the epidermis). Conventional cooling methods, such as direct cryogenic spray, were described as difficult to control, potentially causing frostbite or failing to adequately protect the epidermis from the laser's heat ('594 Patent, col. 1:40-51).
  • The Patented Solution: The invention proposes a hand-held device featuring a cooling element (e.g., a sapphire rod) that is both transparent to the laser and highly thermally conductive. One surface of the element is cooled by a controlled cryogenic spray, while another surface is placed in direct contact with the patient's skin. This allows the device to efficiently remove heat from the skin surface before, during, and after the laser pulse is delivered through the transparent element, thereby protecting the epidermis while treating deeper tissue layers ('594 Patent, Abstract; col. 2:2-15).
  • Technical Importance: This approach provided a method for more precise temperature control at different skin depths, enabling safer and more effective treatment of deeper dermatological conditions.

Key Claims at a Glance

  • The complaint asserts exemplary independent Claim 29 (Compl. ¶33). The complaint states Sciton infringes "one or more claims" of the patent (Compl. ¶32).
  • Independent Claim 29 Essential Elements:
    • A method of treating skin tissue, comprising:
    • generating laser light at a wavelength that in skin tissue is primarily absorbed by water;
    • transmitting the laser light through a transparent material contained in a hand-held unit, placing the hand-held unit in contact with skin tissue; and
    • converting the laser light from a beam to an irradiation pattern such that a portion of the laser light irradiates and damages a first tissue portion, a second portion of the laser light substantially simultaneously irradiates and damages a second tissue portion, and a portion of tissue between the first and second tissue portions is undamaged by the laser light.

U.S. Reissue Patent No. RE43,881

  • Patent Identification: U.S. Reissue Patent No. RE43,881, “Tissue Cooling Rod for Laser Surgery,” issued December 25, 2012.

The Invention Explained

  • Problem Addressed: The '881 Patent, a continuation of the '594 Patent, addresses the same technical problem of preventing superficial skin damage during subsurface laser treatments ('881 Patent, col. 1:40-51).
  • The Patented Solution: The patent describes the same solution involving a thermally conductive, transparent cooling element placed in contact with the skin to regulate temperature during laser application ('881 Patent, col. 2:25-39).
  • Technical Importance: As with the parent patent, this technology aimed to improve the safety and efficacy of cosmetic laser procedures.

Key Claims at a Glance

  • The complaint asserts exemplary independent Claim 29 (Compl. ¶50). The complaint states Sciton infringes "one or more claims" of the patent (Compl. ¶49).
  • Independent Claim 29 Essential Elements:
    • A method of treating skin tissue, comprising:
    • generating laser light at a wavelength that in skin tissue is primarily absorbed by water;
    • transmitting the laser light through a transparent material contained in a hand-held unit;
    • placing the hand-held unit in contact with skin tissue; and
    • converting the laser light from a beam to an irradiation pattern such that a portion of the laser light irradiates and damages a first tissue portion, a second portion of the laser light irradiates and damages a second tissue portion, and a portion of tissue between the first and second tissue portions is undamaged by the laser light.

III. The Accused Instrumentality

  • Product Identification: The complaint accuses Sciton’s HALO Hybrid Fractional Laser and ProFractional laser devices of infringement (Compl. ¶14, 23).
  • Functionality and Market Context:
    • The complaint alleges the HALO device is a "hybrid fractional laser" that applies both non-ablative (1470nm) and ablative (2940nm) laser wavelengths to the same "microscopic treatment zone" (Compl. ¶16). Its handpiece is allegedly placed against the skin during use (Compl. ¶21). The complaint states that the HALO system features "Integrated Cooling and Smoke Evacuation," where the integrated cooling "provides cold air across the treatment zone" (Compl. ¶20). The complaint includes a marketing image of the HALO handpiece (Compl. ¶15, p. 4).
    • The ProFractional device is alleged to be an erbium:YAG laser (2940 nm wavelength) that "ablates narrow-diameter channels into the skin, covering a fraction of the total treatment area" to initiate a wound healing response (Compl. ¶25-26). It is also allegedly used by placing it against the skin (Compl. ¶27). The complaint provides an image of the ProFractional device head (Compl. ¶24, p. 6). The complaint does not describe the cooling mechanism for the ProFractional device.

IV. Analysis of Infringement Allegations

RE42,594 Infringement Allegations

Claim Element (from Independent Claim 29) Alleged Infringing Functionality Complaint Citation Patent Citation
generating laser light at a wavelength that in skin tissue is primarily absorbed by water; HALO and ProFractional generate laser light at wavelengths (1470 nm and 2940 nm) that are primarily absorbed by water in skin tissue. ¶35, 36 col. 6:38-42
transmitting the laser light through a transparent material contained in a hand-held unit, placing the hand-held unit in contact with skin tissue; and HALO and ProFractional transmit laser light through a transparent material in a hand-held unit (handpiece) that is placed in contact with skin tissue. ¶35, 36 col. 3:5-8
converting the laser light from a beam to an irradiation pattern such that a portion of the laser light irradiates and damages a first tissue portion...and a portion of tissue between the first and second tissue portions is undamaged by the laser light. HALO and ProFractional convert the laser light to an irradiation pattern that ablates portions of tissue while leaving adjacent tissue portions undamaged (i.e., fractional treatment). ¶35, 36 col. 7:46-54

RE43,881 Infringement Allegations

Claim Element (from Independent Claim 29) Alleged Infringing Functionality Complaint Citation Patent Citation
generating laser light at a wavelength that in skin tissue is primarily absorbed by water; HALO and ProFractional generate laser light at wavelengths (1470 nm and 2940 nm) that are primarily absorbed by water in skin tissue. ¶52, 53 col. 6:38-42
transmitting the laser light through a transparent material contained in a hand-held unit; HALO and ProFractional transmit laser light through a transparent material within their respective handpieces. ¶52, 53 col. 2:4-6
placing the hand-held unit in contact with skin tissue; and The handpieces of the HALO and ProFractional devices are placed in contact with the patient's skin during treatment. ¶52, 53 col. 3:5-8
converting the laser light from a beam to an irradiation pattern such that a portion of the laser light irradiates...and a portion of tissue between the first and second tissue portions is undamaged by the laser light. HALO and ProFractional convert the laser light to a fractional irradiation pattern, damaging some tissue spots while leaving intervening tissue undamaged. ¶52, 53 col. 7:46-54
  • Identified Points of Contention:
    • Technical Questions: A primary question arises from the complaint's description of the HALO device. It alleges infringement of claims requiring laser transmission "through a transparent material" that is part of a cooling system, yet it also states HALO's cooling is "cold air across the treatment zone" (Compl. ¶20, 35). This raises the question of how, or if, the accused air-cooling system meets the claim limitations which, in the patent's embodiments, describe a solid, cryogen-cooled element in direct thermal contact with the skin. The complaint does not provide sufficient detail to resolve this apparent tension.
    • Scope Questions: The claims require "converting" a laser beam into a fractional "irradiation pattern." The specific mechanism used by the accused devices to create this pattern is not detailed in the complaint. A dispute may arise over whether the accused method of creating a fractional pattern falls within the scope of the term "converting" as defined by the patents.

V. Key Claim Terms for Construction

  • The Term: "transparent material"

  • Context and Importance: This term is central to the invention's cooling mechanism. The infringement analysis may depend on whether this term is construed to cover the cooling architecture allegedly used by the accused devices. Practitioners may focus on this term because the complaint alleges infringement while simultaneously describing HALO’s cooling as "cold air" (Compl. ¶20), creating a potential mismatch with the patent's exemplary embodiments.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claims use the general term "transparent material" without specifying its composition or state (solid, liquid, gas), and the specification refers generally to a "cooling transmitting element" ('594 Patent, col. 9:37-38). This could support an argument that the term is not limited to the specific embodiments.
    • Evidence for a Narrower Interpretation: The patent's abstract, detailed description, and figures consistently describe the "transparent material" as a solid object with high thermal conductivity, such as a "sapphire plate" or "diamond rod," that is directly cooled ('594 Patent, Abstract; col. 3:9-11; Fig. 1). This could support a narrower construction limited to solid-state contact coolers.
  • The Term: "converting the laser light from a beam to an irradiation pattern"

  • Context and Importance: This limitation defines the fractional aspect of the claimed method. The breadth of "converting" will determine what specific technologies infringe, such as physical masking, beam splitting, or digital scanning.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim language itself is functional and does not recite a specific structure for performing the conversion. This may support a construction that encompasses any method of transforming a single beam into a fractional pattern.
    • Evidence for a Narrower Interpretation: The specification discloses specific methods for achieving this, such as "masking the laser light" ('594 Patent, col. 11:49-50) and using a "paterned [sic] cooling element" ('594 Patent, col. 7:46-48). An argument could be made that the term should be limited to these disclosed physical conversion mechanisms.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Sciton induced infringement by instructing customers on how to use the HALO and ProFractional devices in an infringing manner through "websites, product manuals, and other media" and by demonstrating infringing uses (Compl. ¶43, 60).
  • Willful Infringement: The complaint alleges willful infringement based on Sciton's alleged continued infringement after receiving a notice letter from Solta on or about July 14, 2016, more than two years before the patents expired (Compl. ¶37-38, 54-55).

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

  • A core issue will be one of technical operation: Do the accused cooling systems, particularly the "integrated air cooling" alleged for the HALO device, function in a manner that meets the claim requirement of a "transparent material" used for both laser transmission and skin cooling, as understood in the context of the patent specifications? This may become a central question of both claim construction and infringement.
  • A second key question will concern evidentiary proof for past damages: As the patents-in-suit have expired, the case is exclusively for past damages. The litigation will likely focus on establishing the extent of any infringement that occurred prior to October 16, 2018, and calculating the appropriate monetary remedy, whether as a reasonable royalty or lost profits.
  • Finally, the allegation of willfulness will depend on the facts surrounding the 2016 notice letter. A key question for the court will be whether Sciton's alleged conduct after receiving notice was objectively reckless, potentially exposing it to enhanced damages if infringement is found.