DCT
1:21-cv-01734
MacUlogix Inc v. Heru Inc
Key Events
Amended Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: MacuLogix, Inc. (Delaware) and The UAB Research Foundation (Alabama)
- Defendant: Heru, Inc. (Delaware)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; White & Case LLP
- Case Identification: 1:21-cv-01734, D. Del., 02/11/2022
- Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Heru, Inc. is a Delaware corporation.
- Core Dispute: Plaintiffs allege that Defendant’s re:Vive 2.0 wearable diagnostic device infringes three patents related to methods and systems for ophthalmic testing, specifically for measuring dark adaptation to detect macular degeneration.
- Technical Context: The technology concerns diagnostic methods for the early detection of Age-related Macular Degeneration (AMD) by measuring the eye's dark adaptation function, a process impaired by the disease.
- Key Procedural History: The filing is an Amended Complaint. For U.S. Patent No. 11,224,340, Plaintiffs allege providing Defendant with pre-issuance notice on January 14, 2022, and post-issuance notice on January 20, 2022, facts which may be relevant to claims of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2007-02-15 | Earliest Priority Date for ’191 and ’340 Patents |
| 2014-04-01 | Plaintiff MacuLogix commercialized the AdaptDx product |
| 2014-08-05 | U.S. Patent No. 8,795,191 Issued |
| 2018-09-21 | Earliest Priority Date for ’954 Patent |
| 2020-01-01 | Plaintiff MacuLogix launched the AdaptDx Pro product |
| 2021-08-17 | U.S. Patent No. 11,089,954 Issued |
| 2021-11-03 | Defendant Heru announced Dark Adaptation capability for re:Vive product |
| 2021-11-03 | Defendant promoted re:Vive 2.0 at Academy 2021 meeting |
| 2021-11-11 | Defendant's CEO presented on re:Vive 2.0, referencing Plaintiff's product |
| 2022-01-14 | Plaintiffs' counsel provided notice to Defendant that the ’340 patent would issue |
| 2022-01-18 | U.S. Patent No. 11,224,340 Issued |
| 2022-01-20 | Plaintiffs' counsel provided notice to Defendant that the ’340 patent had issued |
| 2022-02-11 | Amended Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,795,191 - "Photobleaching Method" (August 5, 2014)
The Invention Explained
- Problem Addressed: Traditional psychophysical tests to measure dark adaptation, a key indicator of retinal health, often rely on photobleaching the eye with intense, achromatic (white) light, which can increase test duration and cause patient discomfort (Compl. ¶16; ’191 Patent, col. 2:50-63).
- The Patented Solution: The invention proposes an improved method for photobleaching that uses light with a "tailored wavelength spectra" designed to preferentially affect specific photoreceptors (e.g., rods) (’191 Patent, col. 4:1-12). By using specific wavelengths, the method aims to minimize bleaching of photoreceptors not being tested (e.g., cones), which may allow for faster recovery and a more efficient, comfortable test (’191 Patent, col. 10:25-42).
- Technical Importance: This approach suggests a way to make dark adaptation testing, a critical tool for early AMD diagnosis, more targeted and less burdensome for patients than methods using broadband white light (Compl. ¶17-19).
Key Claims at a Glance
- The complaint asserts independent claim 35 for direct infringement and alleges inducement and contributory infringement of method claim 1 (Compl. ¶51-53).
- Claim 1 (Method): A method for photobleaching an eye that includes the steps of:
- Exposing at least a portion of a retina to a photobleaching light with a tailored wavelength spectra.
- The light is effective to photobleach at least a portion of at least one visual pigment.
- The purpose is to accentuate or minimize a response of a subset of photoreceptors.
- Using a psychophysical test to monitor the response, wherein exposure alters the response.
- Claim 35 ("Combination"): A combination for photobleaching a subject's eye, comprising:
- A photobleaching light configured to expose the retina with a tailored wavelength spectra to accentuate or minimize a response of a subset of photoreceptors.
- A headset apparatus to administer a psychophysical test to monitor the response.
U.S. Patent No. 11,089,954 - "Method And Apparatus For Guiding A Test Subject Through An Ophthalmic Test" (August 17, 2021)
The Invention Explained
- Problem Addressed: The patent's background describes the complexity of the macula and the importance of ophthalmic diagnostic testing, implying a need for systems that can administer such tests effectively and consistently (’954 Patent, col. 1:27-55).
- The Patented Solution: The invention describes an ophthalmic testing system, potentially in a head-wearable device, that incorporates an "automatic subject-instruction system" (’954 Patent, Abstract). This system guides the subject through the diagnostic test using commands, which can be in natural language, and can provide assistance based on the subject's requests or performance (’954 Patent, col. 2:22-55). The system can provide verbal commands and analyze the subject's responses to determine if additional guidance is required (’954 Patent, col. 46:25-31, col. 47:51-61).
- Technical Importance: Automating the instruction and guidance process may reduce the need for a human technician, improve test consistency, and make ophthalmic testing more accessible in various settings (Compl. ¶30).
Key Claims at a Glance
- The complaint asserts independent claim 1 for direct infringement (Compl. ¶58).
- Claim 1 (System): An ophthalmic testing system for administering a test, comprising:
- An optical system with a light source for a photobleaching light and a stimulus light.
- An electromechanical interface triggerable by the test subject.
- Computing processors, memory, and programs stored therein.
- The programs are executed to: provide introductory information; provide commands for the subject to follow; analyze the subject's responses, including to determine if the subject requires additional guidance; and provide guiding instructions to complete the test successfully.
U.S. Patent No. 11,224,340 - "Photobleaching Method" (January 18, 2022)
- Technology Synopsis: Like the related ’191 Patent, this patent addresses the challenges of using intense, broadband light for photobleaching in dark adaptation tests (’340 Patent, col. 2:50-63). The invention describes a method and system for measuring the eye's ability to adapt to darkness by first photobleaching photoreceptors with a light having a "tailored wavelength spectra" before administering a dark adaptometry test (’340 Patent, Claim 1, 20).
- Asserted Claims: The complaint asserts independent system claim 20 for direct infringement and independent method claim 1 for indirect infringement (Compl. ¶63-65).
- Accused Features: The complaint alleges that the re:Vive 2.0 product's use of a green photobleaching light, a red stimulus light, and a headset apparatus to measure dark adaptation infringes the ’340 Patent (Compl. ¶39-40).
III. The Accused Instrumentality
Product Identification
- Defendant Heru, Inc.'s re:Vive 2.0 product (Compl. ¶33).
Functionality and Market Context
- The re:Vive 2.0 is described as a "wearable gamified diagnostic solution" in the form of a headset that provides multiple testing modalities, including "Dark Adaptation" (Compl. ¶35). The complaint alleges that the device operates by exposing a subject's eye to a "green photobleaching light" to target rod photoreceptors, followed by a "red light" target stimulus (Compl. ¶37, 39). It is alleged to include an "electromechanical interface" called a "bumper" for the user to signal observation of the stimulus light (Compl. ¶43). The system is also alleged to feature an "Automated, AI powered" virtual guide that provides instructions and feedback to the patient during the test (Compl. ¶41, 43). A picture of the re:Vive 2.0 headset and an associated tablet interface is provided in the complaint (Compl. ¶34, p. 9). The complaint alleges Defendant has positioned the re:Vive 2.0 to compete with Plaintiffs' AdaptDx and AdaptDx Pro products and has used Plaintiffs' products as commercial benchmarks (Compl. ¶44, 46).
IV. Analysis of Infringement Allegations
’191 Patent Infringement Allegations
| Claim Element (from Independent Claim 35) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a combination for photobleaching a test subject's eye, the combination comprising: (a) a photobleaching light configured to expose at least a portion of the test subject's retina with a tailored wavelength spectra... | The re:Vive 2.0 product is a combination that uses a "green photobleaching light," alleged to be a tailored wavelength spectra. | ¶37 | col. 4:1-5 |
| ...within the visible spectrum effective to photobleach at least a portion of at least one visual pigment in the retina to accentuate or minimize (accentuate) a response of a subset of photoreceptors (rod photoreceptors) in the retina to the photobleaching light; and | The complaint alleges the green light is used to photobleach visual pigment in the retina and to "accentuate" the response of rod photoreceptors. | ¶37 | col. 4:5-9 |
| (b) a headset apparatus to administer a psychophysical test (a dark adaptation test) to monitor the response wherein the exposure to the photobleaching light alters the response. | The re:Vive 2.0 is a headset apparatus that administers a dark adaptation test to monitor the subject's response to the photobleaching. | ¶37 | col. 4:9-12 |
’954 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| an ophthalmic testing system for administering an ophthalmic test to a test subject's eye, the system comprising: (a) an optical system with a light source configured to emit a photobleaching light and a stimulus light as part of the ophthalmic test; | The re:Vive 2.0 is an ophthalmic testing system that uses an optical system to emit a green photobleaching light and a red stimulus light for a dark adaptation test. | ¶39, 43 | col. 45:11-16 |
| (b) an electromechanical interface that can be triggered by the test subject during the ophthalmic test when the subject sees a stimulus light... | The re:Vive 2.0 is alleged to use an interface Heru calls a "bumper," which can be triggered by the test subject upon seeing a stimulus light. | ¶43 | col. 46:5-7 |
| (c) computing processors, memory, and programs... executed by the processors [to] provide introductory information... provide commands for the subject to follow... | The system's "Automated" and "AI powered" functionality, including its "virtual 'personality'," allegedly provides introductory information and commands like "Welcome to Heru, I will be your guide today." | ¶41, 43 | col. 45:36-47 |
| ...analyze the responses provided by the subject during the dark adaptation test, including to determine whether the subject requires additional guidance to perform the test correctly, and provide guiding instructions for the subject to complete the dark adaptation test successfully... | The complaint alleges the re:Vive 2.0's programs analyze subject responses to determine if additional guidance is needed and then provide such guiding instructions. | ¶43 | col. 45:47-52 |
Identified Points of Contention
- Scope Questions: A primary issue for the ’191 and ’340 patents may be whether the term "tailored wavelength spectra" can be construed to read on the "green photobleaching light" allegedly used by the accused device. The dispute may center on how specific a "tailoring" is required by the claims.
- Technical Questions: For the ’954 Patent, a key factual question may be what evidence the complaint provides that the accused product's "AI powered" system performs the specific, multi-step function of (1) analyzing responses, (2) determining a need for additional guidance based on that analysis, and (3) providing said additional guidance, as recited in the claim. The complaint alleges this occurs, but the nature of the evidence for this feedback loop is not detailed (Compl. ¶43).
V. Key Claim Terms for Construction
The Term: "tailored wavelength spectra" (from ’191 Patent, Claim 1 and 35; ’340 Patent, Claim 1 and 20)
Context and Importance: This term is central to the infringement allegations for two of the three asserted patents. Its construction will determine whether the accused product's use of a "green photobleaching light" falls within the scope of the claims. Practitioners may focus on this term because the outcome of its construction could be dispositive for a significant portion of the case.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests that a purpose of tailoring is to move away from "achromatic (white) or very broadband light" (’340 Patent, col. 2:48-51). This may support an interpretation where any light that is not broadband white light, such as a monochromatic green light, qualifies as "tailored."
- Evidence for a Narrower Interpretation: The specification provides specific examples of tailored spectra, such as a spectrum "consisting essentially of a wavelength of light of 505 nm or a range of wavelengths of light centered on 505 nm" to preferentially bleach rods (’340 Patent, col. 9:30-34). This could support an interpretation that "tailored" requires a spectrum specifically selected for a purpose disclosed in the patent, not just any non-white light.
The Term: "analyze the responses... including to determine whether the subject requires additional guidance" (from ’954 Patent, Claim 1)
Context and Importance: This limitation defines the "intelligence" of the claimed automated system. The infringement analysis will hinge on whether the accused product's "AI" performs this specific analytical and adaptive feedback function. Practitioners may focus on this term to distinguish between a simple, pre-programmed script and a truly interactive guidance system as claimed.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent's summary describes an "automatic subject-instruction system for communicating with the subject so as to guide the subject through the diagnostic test" (’954 Patent, col. 2:22-26). This broader statement could be used to argue that any automated guidance qualifies.
- Evidence for a Narrower Interpretation: The claim language itself requires a specific cause-and-effect loop: analyzing responses to determine a need for additional guidance. The specification further supports this, stating the processor can be configured to "provide the test subject with additional commands based on the response received from the test subject" (’954 Patent, col. 46:25-31). This suggests the system must be responsive and adaptive, not merely delivering a static set of instructions.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement of the method claims of the ’191 and ’340 patents, based on Defendant offering to sell and selling the re:Vive 2.0 product and directing eye care professionals on its infringing use (Compl. ¶52, 64). Contributory infringement is also alleged on the basis that the dark adaptation functionality is not a staple article of commerce and is especially adapted for infringement (Compl. ¶53, 65).
- Willful Infringement: Willfulness is alleged for all three patents. For the ’191 and ’954 patents, the allegations are based on pre-suit knowledge, citing Defendant's use of Plaintiffs' patented AdaptDx and AdaptDx Pro products as commercial benchmarks and the fact that these products are marked with patent notices (Compl. ¶44-47). The complaint includes a slide from a presentation by Defendant's CEO, which features a picture of Plaintiffs' AdaptDx device under the heading "Current Standard of Care" (Compl. ¶35, p. 10). For the ’340 Patent, willfulness is alleged based on actual notice provided by Plaintiffs' counsel to Defendant before and after the patent issued in January 2022 (Compl. ¶48-49).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "tailored wavelength spectra," which the patents contrast with broadband white light, be construed to cover the monochromatic "green photobleaching light" used in the accused system? The case may turn on whether "tailored" implies a specific spectral shape disclosed in the patent or more broadly covers any non-achromatic light source selected for a purpose.
- A key evidentiary question will be one of functional operation: does the accused re:Vive 2.0 product's "AI powered" guidance system perform the specific, adaptive feedback loop required by Claim 1 of the ’954 patent—analyzing user input to determine a need for additional guidance—or does it provide a more generic, pre-scripted set of instructions that lacks this responsive element?
- The question of willfulness will be significant, particularly given the complaint’s visual evidence. The court will need to consider whether Defendant's alleged use of Plaintiffs' patented products as a "benchmark," combined with the patent markings on those products, constitutes the kind of egregious conduct that warrants enhanced damages.