DCT

3:23-cv-00578

Blephex LLC v. Nulids LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:23-cv-00578, S.D. Cal., 03/31/2023
  • Venue Allegations: Venue is asserted based on Defendant's principal place of business being located in Escondido, California, within the Southern District of California, and on alleged acts of infringement occurring within the district.
  • Core Dispute: Plaintiff alleges that Defendant’s electromechanical eyelid hygiene devices, and the methods of using them, infringe a patent directed to methods for treating ocular disorders by cleaning the eyelid margin.
  • Technical Context: The technology concerns handheld, powered medical devices that use a moving, soft tip to remove biological debris from a patient's eyelid margin to treat common conditions like blepharitis and meibomian gland dysfunction.
  • Key Procedural History: The complaint notes that the patent-in-suit is a continuation of a patent from the same family that was previously litigated in BlephEx, LLC v. Myco Indus., Inc. In that case, the court granted a preliminary injunction against a "near copy" of Plaintiff's device, which was affirmed by the Federal Circuit. A related inter partes review (IPR) petition filed by the defendant in that case was voluntarily terminated before an institution decision.

Case Timeline

Date Event
2012-07-24 Priority Date for U.S. Patent No. 11,083,621
2013-07-03 Plaintiff BlephEx sells its first BlephEx® device
2018-06-01 Defendant launches its "At-Home NuLids Device" (approx.)
2021-08-10 U.S. Patent No. 11,083,621 Issues
2023-01-05 Defendant launches its "NuLids Pro" product
2023-03-31 Complaint Filed

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

U.S. Patent No. 11,083,621 - "Instrument for Treating an Ocular Disorder"

  • Patent Identification: U.S. Patent No. 11,083,621 (“Instrument for Treating an Ocular Disorder”), issued August 10, 2021.

The Invention Explained

  • Problem Addressed: The patent describes prior art home treatments for eyelid margin disorders as suffering from "limited success due to the practical difficulties of cleaning one's own eye with an imprecise instrument such as a fingertip or cotton swab" (’621 Patent, col. 2:1-5). These methods often fail to "totally cleanse the margin of the eyelid, the base of the eyelashes, and the meibomian glands" (Compl. ¶23; ’621 Patent, col. 2:13-15).
  • The Patented Solution: The invention is a method using an electromechanical device to solve this problem (’621 Patent, Abstract). The device operably moves a soft, resilient "contact member" or "swab" (e.g., a medical-grade sponge) that is brought into contact with the eyelid margin to physically remove debris (’621 Patent, col. 4:1-10, col. 7:25-41). This provides a more effective and targeted cleaning than was previously possible with manual methods.
  • Technical Importance: The method provided a repeatable and effective means for healthcare providers, and later patients, to debride the eyelid margin, addressing a persistent challenge in treating chronic ophthalmic conditions (Compl. ¶11, ¶24).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 12, with a detailed analysis focused on Claim 1 (Compl. ¶27, ¶39).
  • Independent Claim 1 recites a method with the following essential elements:
    • A method of treating an eye for an ocular disorder with a contact member comprising a soft and resilient material operably connected to an electromechanical device.
    • Effecting movement of the contact member relative to the electromechanical device, wherein the movement comprises electromechanical rotation of the contact member.
    • While the contact member is being moved, contacting the eyelid margin with the contact member without lifting the eyelid margin from the eye.
    • Scrubbing the portion of the eyelid margin that includes the removable debris with the contact member.
    • Impacting the debris with the contact member to remove debris from the eye.
  • The complaint does not specify which, if any, dependent claims will be asserted.

III. The Accused Instrumentality

Product Identification

  • The "NuLids Pro" and "At-Home NuLids Device" systems (Compl. ¶39). The complaint alleges the two products are "substantially the same" for infringement purposes (Compl. ¶33).

Functionality and Market Context

  • The accused products are described as electromechanical devices used for eyelid hygiene (Compl. ¶32, ¶34). They utilize disposable, soft silicone tips that are operably connected to a handheld motorized device (Compl. ¶32, ¶42).
  • The complaint alleges the tips perform an "alternating rotational movement" to create an "oscillatory effect" for cleaning the eyelid margin (Compl. ¶59, ¶61). A promotional video for the NuLids Pro device describes this as a "massaging action" and "oscillation" that "loosens up meibum" (Compl. ¶59). The complaint provides an image from the NuLids webpage showing the device's disposable tip and handheld electromechanical body (Compl. ¶42, p. 11).
  • The "NuLids Pro" is marketed for in-office professional use, while the "At-Home NuLids Device" is marketed for patient use at home (Compl. ¶32-34).

IV. Analysis of Infringement Allegations

'621 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
[a] method of treating an eye for an ocular disorder with a contact member comprising a soft and resilient material operably connected to an electromechanical device... The NuLids devices are instructed for use in treating ocular disorders like blepharitis and meibomian gland dysfunction. They use a "soft and resilient" silicone tip connected to a handheld electromechanical device. ¶40-47, ¶49-56 col. 7:25-30
effecting movement of the contact member relative to the electromechanical device... wherein the movement comprises electromechanical rotation of the contact member The NuLids device tip is alleged to rotate "back and forth" to create an "oscillatory effect." The complaint provides a diagram from Defendant's webpage illustrating this alternating rotational movement. ¶57-62, ¶59 (p. 17) col. 7:31-36
while the contact member is being moved by the electromechanical device, contacting the eyelid margin with the contact member without lifting the eyelid margin from the eye... Instructions allegedly direct users to apply the moving tip to a closed eyelid. The complaint includes a video still showing the device being used on a patient's closed eye, allegedly without any separate step of lifting the eyelid. ¶63-66, ¶66 (p. 21) col. 7:37-41
...so as to scrub the portion of the eyelid margin that includes the removable debris with the contact member thereby impacting the debris with the contact member to remove debris from the eye. The devices are used to contact and remove debris from the eyelid margin. The complaint includes before-and-after photos from Defendant's website purporting to show the removal of such debris. ¶63-65, ¶67, ¶48 (p. 13) col. 7:37-41

Identified Points of Contention

  • Scope Questions: A central dispute may arise over whether the "electromechanical rotation" required by Claim 1 can be interpreted to cover the accused devices' "oscillating" or "back and forth" rotational motion. The defense may argue that "rotation" implies continuous, unidirectional movement, which is distinct from oscillation.
  • Technical Questions: The claim requires "scrub[bing] the portion of the eyelid margin." The defense may contend that its products perform a gentler "massaging" or "stimulating" action that does not rise to the level of "scrubbing." The evidence needed to prove this claim element will be a key factual question.
  • Scope Questions: The interpretation of the negative limitation "without lifting the eyelid margin from the eye" may be contested. The parties may dispute whether this precludes any incidental lifting or only a deliberate, separate step of lifting the eyelid prior to or during treatment.

V. Key Claim Terms for Construction

The Term: "electromechanical rotation"

  • Context and Importance: This term is critical because the accused devices are described as creating an "oscillatory effect" through "alternating rotational movement" (Compl. ¶59, ¶61). The case may depend on whether this motion constitutes "electromechanical rotation" under the patent's claims.
  • Intrinsic Evidence for a Broader Interpretation: The patent specification describes the movement transmitted to the swab as potentially including "a reciprocating movement 38a, a rotating movement 38b, or a vibrating movement 38c" (’621 Patent, col. 4:50-55). Plaintiff may argue that because the specification contemplates various types of motion, the specific term "rotation" in the claim should not be read so narrowly as to exclude oscillating or reciprocating rotation.
  • Intrinsic Evidence for a Narrower Interpretation: Defendant may argue that the claim drafter specifically chose the word "rotation," distinguishing it from the "reciprocating" or "vibrating" movements also disclosed. This could support an interpretation limiting the term to continuous, 360-degree motion, which would potentially exclude the accused oscillating motion.

The Term: "scrub the portion of the eyelid margin"

  • Context and Importance: Practitioners may focus on this term because Defendant's marketing materials describe the accused action as "massaging" and "loosening" (Compl. ¶59), which may be presented as functionally different from "scrubbing."
  • Intrinsic Evidence for a Broader Interpretation: The patent’s background focuses on the goal of "physically scrubbing the eyelid margin" to remove debris, and the overall purpose is the "removal of debris, oil, and scurf" (’621 Patent, col. 1:46-48, 60-63). This context may support interpreting "scrub" to mean any effective physical debridement.
  • Intrinsic Evidence for a Narrower Interpretation: The term "scrub" could imply a more abrasive or forceful action than what a "soft and resilient" sponge tip is intended to perform. Defendant could argue that the intended action is a less aggressive cleaning that does not meet the ordinary meaning of "scrub."

VI. Other Allegations

Indirect Infringement

  • The complaint alleges active inducement under 35 U.S.C. § 271(b). The allegations are based on Defendant's affirmative acts of providing instructional materials—including user manuals, promotional and instructional videos, and website content—that allegedly encourage and direct both healthcare providers and patients to use the accused devices in a manner that performs the steps of the claimed method (Compl. ¶87-88).

Willful Infringement

  • Willfulness is alleged based on Defendant’s purported knowledge of the ’621 Patent. The complaint alleges this knowledge stems from multiple sources, including: the Defendant's founder being a former user of Plaintiff's patented device, alleged discussions between the parties, and Defendant's own patent applications which cite patents in the BlephEx portfolio (Compl. ¶79, ¶85). The complaint alleges knowledge existed at least as of the complaint's filing date, and potentially as early as the patent's issuance date (Compl. ¶79).

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

  • A core issue will be one of definitional scope: can the claim term "electromechanical rotation" be construed to read on the "oscillating" or "alternating rotational movement" of the accused devices, or is its meaning restricted to continuous, unidirectional rotation?
  • A key evidentiary question will be one of functional characterization: does the accused devices' "massaging" action, intended to "loosen" debris, constitute "scrub[bing] the portion of the eyelid margin" as affirmatively required by the claim, or is there a functional difference that places the accused method outside the claim's scope?
  • The case may also hinge on the negative limitation "without lifting the eyelid margin from the eye." A central question will be what factual evidence is sufficient to prove this limitation is met, and whether the instructed use on a closed eyelid is dispositive of the issue.