DCT

3:26-cv-04166

Kent Imaging Inc v. MolecuLight Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:26-cv-04166, N.D. Cal., 05/06/2026
  • Venue Allegations: Venue is alleged to be proper because the Defendants are foreign corporations not resident in the United States and may therefore be sued in any judicial district.
  • Core Dispute: Plaintiffs seek a declaratory judgment that their SnapshotGLO® medical imaging device does not infringe U.S. Patent No. 10,438,356, which is owned by and/or licensed to the Defendants and relates to fluorescence-based wound imaging.
  • Technical Context: The technology involves using light to induce autofluorescence in biological tissues to non-invasively detect and assess bacterial presence in wounds, a method intended to improve upon slower, conventional diagnostic techniques.
  • Key Procedural History: The action follows a cease-and-desist letter sent by Defendant MolecuLight in April 2025 and a subsequent patent infringement complaint filed by MolecuLight at the U.S. International Trade Commission (ITC) in December 2025. This declaratory judgment action is filed while the ITC investigation is ongoing, with Plaintiffs seeking to resolve the "cloud of uncertainty" created by Defendants' infringement accusations.

Case Timeline

Date Event
2014-07-24 '356 Patent Priority Date
2019-10-08 '356 Patent Issue Date
2025-04-23 MolecuLight sends cease-and-desist letter to Kent Imaging
2025-04-30 Kent Imaging responds to letter, denying infringement
2025-09-01 Accused Product (SnapshotGLO®) launched (approximate date)
2025-12-29 MolecuLight files complaint at the U.S. International Trade Commission
2026-04-17 SnapshotGLO® User Guide (Model KB100) revised
2026-05-06 Complaint for Declaratory Judgment filed

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

U.S. Patent No. 10,438,356 - "Collection and Analysis of Data for Diagnostic Purposes"

  • Patent Identification: U.S. Patent No. 10,438,356, "Collection and Analysis of Data for Diagnostic Purposes," issued October 8, 2019 (the "'356 Patent"). Compl. ¶74

The Invention Explained

  • Problem Addressed: The patent's background describes the challenges in clinical wound care, where assessment often relies on subjective visual inspection and slow, insensitive bacteriological tests, potentially delaying effective treatment ʼ356 Patent, col. 1:20-44
  • The Patented Solution: The invention is a system and method for determining the bacterial load in a target like a wound Compl. ¶75 It uses a light source to illuminate the wound, causing bacteria and tissue components to autofluoresce. An optical sensor, such as a digital camera, detects these fluorescence signals, and a processor analyzes the signal data by, for example, comparing pixel intensities to a threshold to calculate the bacterial load and output corresponding data '356 Patent, abstract '356 Patent, col. 2:7-25
  • Technical Importance: This technology offers a method for real-time, non-invasive, and objective assessment of bacterial presence in wounds, intended to guide therapeutic intervention more effectively than traditional methods ʼ356 Patent, col. 1:39-44

Key Claims at a Glance

  • The complaint's non-infringement analysis focuses on independent claim 20, noting that independent claims 1 and 33 contain similar limitations Compl. ¶¶81-82 Compl. ¶84 The underlying ITC action asserts claims 20-25, 27, 28, 30, and 31 Compl. ¶79
  • The essential elements of independent claim 20 are:
    • An excitation light source configured to illuminate a target with a "uniform field of excitation light."
    • An optical sensor to detect signals (e.g., fluorescence, absorbance) from the illuminated target.
    • A processor configured to receive the signals, identify pixels of bacterial fluorescence above a threshold, "calculate bacterial load" based on those pixels, and "output data regarding the bacterial load."
    • A display for showing the output data from the processor.
      Compl. ¶80
  • The complaint notes that Plaintiffs reserve the right to assert non-infringement of all claims of the '356 patent Compl. ¶85

III. The Accused Instrumentality

Product Identification

  • The SnapshotGLO®, a medical imaging device for wound care Compl. ¶¶5-6

Functionality and Market Context

  • The SnapshotGLO® is described as a noninvasive, point-of-care imaging device that enables clinicians to detect and visualize bacteria in wounds that are not visible to the naked eye Compl. ¶86
  • It operates by using two ultraviolet (395 nm) LEDs to illuminate a wound, causing bacteria to autofluoresce Compl. ¶89 The device captures and processes images to display a standard color clinical image alongside a fluorescence image, which can include an overlay to highlight bacterial presence Compl. ¶90 The complaint asserts the accused device displays a color clinical image next to a fluorescence image to help clinicians visually identify bacteria Compl. ¶90
  • The device is intended to highlight image portions that correlate with elevated levels of bacterial bioburden, specifically above 10^4 colony-forming units per gram Compl. ¶91 The device is FDA 510(k) cleared Compl. ¶87

IV. Analysis of Infringement Allegations

The complaint for declaratory judgment outlines Plaintiffs' bases for non-infringement with respect to the '356 patent.

Claim Element (from Independent Claim 20) Alleged Non-Infringing Functionality Complaint Citation Patent Citation
at least one excitation light source configured to directly illuminate a target with a uniform field of excitation light... The SnapshotGLO® User Guide allegedly states the excitation intensity is not uniform across the imaging field, with pixels farther from the center showing lower signals. The guide instructs users to take multiple images for larger wounds due to this non-uniformity. ¶¶94-97 col. 2:9-11
a processor configured to ... calculate bacterial load of the target based on the identified pixels, and to output data regarding the bacterial load of the target... The SnapshotGLO® allegedly does not calculate or determine a quantitative bacterial load. The User Guide is cited as stating the images are "not quantitative" and only "allow relative comparison within regions in a single image." The device presents images for visualization, and its processor does not perform a specific calculation of bacterial load. ¶¶101-104 col. 2:20-23
  • Identified Points of Contention:
    • Scope Questions: A central dispute may concern the proper construction of "uniform field of excitation light." The case raises the question of whether this term requires a high degree of mathematical uniformity across the entire field, or if it can be construed more broadly to cover a light field that is "generally" or "sufficiently" uniform for its intended purpose, even with some intensity drop-off at the edges.
    • Technical Questions: The analysis will likely focus on the meaning of "calculate bacterial load." A key question is whether the accused product's function of processing an image to highlight pixels above a certain intensity for qualitative visual comparison constitutes a "calculation" of "bacterial load," or if the claim requires the processor to determine and/or output a specific quantitative value representing that load.

V. Key Claim Terms for Construction

  • The Term: "uniform field of excitation light"

    • Context and Importance: This term is the foundation of Plaintiffs' first non-infringement argument. Practitioners may focus on this term because its construction could be dispositive. If the accused device's light field is found to be outside the scope of "uniform," infringement may be avoided.
    • Intrinsic Evidence for a Broader Interpretation: A party seeking a broader definition might argue that the patent does not specify a required degree of uniformity. The specification also uses the term "homogeneous field" '356 Patent, col. 2:11, which could be interpreted as substantially uniform in a practical sense, rather than perfectly so.
    • Intrinsic Evidence for a Narrower Interpretation: A party seeking a narrower definition may argue that the plain meaning of "uniform" implies a consistent intensity across the target area. Plaintiffs leverage their own User Guide, which allegedly admits to non-uniformity, as extrinsic evidence that their device does not meet this limitation Compl. ¶¶95-97

  • The Term: "calculate bacterial load"

    • Context and Importance: This term is critical to Plaintiffs' second non-infringement argument. The dispute centers on whether the accused device's processor performs the claimed "calculation."
    • Intrinsic Evidence for a Broader Interpretation: The claim language recites a processor configured "to identify pixels... above a predetermined threshold, to calculate bacterial load... based on the identified pixels" '356 Patent, claim 20 A party could argue that the act of identifying and processing pixels based on a threshold is itself a "calculation," and that the "bacterial load" is represented by the resulting visual output, not necessarily a numerical value.
    • Intrinsic Evidence for a Narrower Interpretation: Plaintiffs argue that "calculate" implies a quantitative measurement, which they allege their device does not perform, citing their User Guide's statement that the images are "not quantitative" Compl. ¶102 A party may point to other claims, such as claim 1 which recites "determining a bacterial load... by summing the identified pixels," to suggest that the patent contemplates a quantitative, numerical step '356 Patent, claim 1

VI. Other Allegations

  • Indirect Infringement: The complaint references the allegations from the separate ITC action, where MolecuLight accused Plaintiffs of induced infringement by creating and distributing user manuals and marketing materials instructing on the use of the SnapshotGLO® Compl. ¶22 Contributory infringement was also alleged on the basis that the accused device is a material part of the invention and not a staple article of commerce Compl. ¶23
  • Willful Infringement: The complaint does not allege willfulness but establishes the basis for such a claim by noting that MolecuLight sent Kent Imaging a cease-and-desist letter on April 23, 2025, providing pre-suit knowledge of the '356 patent and the infringement accusations Compl. ¶16

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

  • A core issue will be one of definitional scope: can the term "uniform field of excitation light," as claimed in the patent, be construed to read on the accused device's illumination system, which is alleged in the complaint to have a non-uniform intensity profile?
  • A second central question will be one of functional interpretation: does the accused device's processing of image data to highlight areas of fluorescence for qualitative visual comparison constitute a "calculation" of "bacterial load" as required by the claim, or does the claim term necessitate a quantitative output that the accused device allegedly does not provide?
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