DCT
1:24-cv-00649
Optrascan Inc v. Morphle Labs Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Optrascan, Inc. (California)
- Defendant: Morphle Labs, Inc. (Delaware)
- Plaintiff’s Counsel: Potter Anderson & Corroon LLP
- Case Identification: 1:24-cv-00649, D. Del., 07/10/2024
- Venue Allegations: Venue is asserted in the District of Delaware based on Defendant's incorporation in the state.
- Core Dispute: Plaintiff alleges that Defendant’s digital slide scanners and associated analysis software infringe patents related to automated slide handling and the automated analysis of biological samples to predict immunotherapy efficacy.
- Technical Context: The lawsuit is in the field of digital pathology, a technology that automates the traditionally manual process of preparing, scanning, and analyzing microscope slides to improve throughput and diagnostic consistency.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with written notice of its infringing activity no later than November 17, 2022, a fact that may be relevant to the claim of willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2016-08-24 | '365 Patent Priority Date |
| 2017-06-13 | '376 Patent Priority Date |
| 2019-07-02 | '365 Patent Issue Date |
| 2020-03-10 | '376 Patent Issue Date |
| 2022-11-17 | Alleged written notice of infringement sent to Defendant |
| 2024-07-10 | First Amended Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,338,365 - Slide Storage, Retrieval, Transfer, and Scanning System for a Slide Scanner, issued July 2, 2019
The Invention Explained:
- Problem Addressed: The patent’s background section identifies the inefficiency of manual slide loading for microscopic analysis and notes that existing automated scanners often have small capacities that cannot be scaled to meet growing testing demands (’365 Patent, col. 1:20-31, 1:51-57).
- The Patented Solution: The invention is a multi-part, automated system for managing high volumes of microscope slides. As described in the specification, the system comprises a high-capacity "slide storage assembly" (e.g., a carousel) that holds multiple "slide baskets." A "slide basket transfer assembly" retrieves an entire basket, and a separate "slide transfer assembly" then retrieves an individual slide from that basket and delivers it to a scanning stage for imaging (’365 Patent, Abstract; col. 2:56-65). This modular approach is designed to be robust, scalable, and low-cost.
- Technical Importance: The technology aims to solve a key bottleneck in digital pathology by creating a high-throughput, fully automated workflow for the physical handling of slides, from storage to scanning. (’365 Patent, col. 1:46-57).
Key Claims at a Glance:
- The complaint asserts at least independent claim 1 (Compl. ¶15).
- The essential elements of claim 1 include:
- a slide scanning stage configured to receive a slide;
- a slide storage assembly configured to store at least one slide basket;
- a slide basket transfer assembly configured to retrieve and store the slide basket from the slide storage assembly;
- a slide transfer assembly configured to retrieve a slide from the slide basket and deliver it to the slide scanning stage;
- a slide basket holder of the slide basket transfer assembly configured to move vertically along a Z axis; and
- a support base of the slide transfer assembly configured to move horizontally in an X-Y plane perpendicular to the Z axis.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 10,586,376 - Automated Method of Predicting Efficacy of Immunotherapy Approaches, issued March 10, 2020
The Invention Explained:
- Problem Addressed: The patent addresses the challenge of predicting a patient's response to immunotherapy, which often depends on evaluating multiple, complex immune-biomarkers within a tumor microenvironment. The patent notes that manual evaluation is challenging and lacks reproducibility, and that a need exists for an integrated, automated analytics tool (’376 Patent, col. 1:33-49, 2:8-12).
- The Patented Solution: The invention is an automated method, integrated with a slide scanner, for analyzing digitized tissue samples. The method involves acquiring a slide image, executing a cell segmentation process to identify individual cells, analyzing those cells using a classification algorithm to determine both a "tumor cell percent positivity value" and an "immune cell percent positivity value," and finally, calculating a "treatment efficacy score" based on those two values (’376 Patent, Abstract; col. 5:1-12).
- Technical Importance: The invention provides a consolidated system that automates not just image acquisition but also the quantitative analysis needed for immuno-oncology, potentially providing a more accurate and objective basis for clinical decisions (’376 Patent, col. 2:2-7).
Key Claims at a Glance:
- The complaint asserts at least independent claim 1 (Compl. ¶31).
- The essential steps of claim 1 include:
- (A) providing an automated slide scanning system electronically connected to a processing device;
- (B) receiving a sample slide with a mounted tissue sample;
- (C) acquiring at least one slide image of the tissue sample;
- (D) executing at least one cell segmentation process to identify a plurality of cells;
- (E) analyzing the cells with a classification algorithm to identify a tumor cell percent positivity value and an immune cell percent positivity value; and
- (F) calculating a treatment efficacy score from the tumor and immune cell positivity values.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
- Product Identification: The complaint names the Morphle Labs "MorphoLens 240" and "HemoLens 16" slide scanners as the accused instrumentalities (Compl. ¶¶15, 31). The "MorphoLens 6" and "Hemolens" are also mentioned (Compl. ¶¶23, 36).
- Functionality and Market Context:
- The MorphoLens 240 is described as a "high throughput workhorse" for digital pathology (Compl. p. 6). The complaint alleges it features a "Slide Rack" that holds 40 carriers, with each carrier holding 6 slides, for a total batch capacity of 240 slides (Compl. p. 6, ¶15). A robotic mechanism is alleged to retrieve carriers and individual slides for automated scanning (Compl. ¶¶18-19).
- The HemoLens 16 is described as a system featuring "AI-enabled Cell Differentiation" (Compl. p. 16). It is alleged to automatically scan slides and use a local GPU to run AI that classifies, sorts, and flags cells, such as white blood cells (WBCs), and identifies various abnormalities (Compl. ¶¶31, 33, p. 17).
- The complaint screenshot of the MorphoLens 240's slide rack shows a high-capacity storage system with numbered slots for slide carriers (Compl. p. 5, ¶15).
IV. Analysis of Infringement Allegations
'365 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a slide scanning stage configured to receive a slide into a slide holder below a microscope objective in order to scan the slide | The MorphoLens 240 has a slide scanning stage that receives a slide into a holder below an objective for scanning. | ¶16 | col. 2:56-59 |
| a slide storage assembly configured to store at least one slide basket, wherein each of the at least one slide basket is configured to store a plurality of slides | The MorphoLens 240 includes a rack (alleged "slide storage assembly") that stores carriers (alleged "slide basket"), each holding multiple slides. | ¶15 | col. 3:7-14 |
| a slide basket transfer assembly configured to retrieve and store the at least one slide basket from and into the slide storage assembly | The MorphoLens 240 includes a "slide basket transfer assembly" that retrieves and stores a carrier from the storage assembly. This is supported by video evidence. | ¶18 | col. 3:1-5 |
| a slide transfer assembly configured to retrieve a slide from the slide basket transfer assembly, deliver the slide to the slide scanning stage... and return the slide | The MorphoLens 240 includes a "slide transfer assembly" that retrieves a slide from the carrier, delivers it to the scanning stage, and returns it. | ¶19 | col. 3:65-col. 4:2 |
| a slide basket holder of the slide basket transfer assembly being configured to move vertically along a Z axis | The slide basket holder of the transfer assembly moves vertically along a Z axis to transfer a carrier from the storage rack. | ¶21 | col. 4:11-15 |
| a support base of the slide transfer assembly being configured to move horizontally in an X-Y plane... to transfer a slide from the slide basket transfer assembly to the slide scanning stage | A support base of the slide transfer assembly moves horizontally in an X-Y plane to transfer the slide to the scanning stage. | ¶22 | col. 6:1-6 |
- Identified Points of Contention:
- Structural Questions: The complaint asserts infringement of both a "slide basket transfer assembly" and a "slide transfer assembly". It also invokes the doctrine of equivalents, stating that the portions of the accused product performing these functions "perform the same functions... in substantially the same way" (Compl. ¶20). This suggests a potential dispute over whether the accused product's robotic system constitutes two structurally distinct "assemblies" as claimed, or a single, integrated assembly.
- Functional Questions: A video screenshot shows a robotic arm mechanism that appears to select a slide carrier (Compl. p. 11, ¶21). The infringement case will depend on whether this single mechanism can be shown to perform the distinct functions of both the claimed "slide basket transfer assembly" and the "slide transfer assembly".
'376 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (D) executing at least one cell segmentation process on the slide image through the processing device in order to identify a plurality of cells from the slide image | The HemoLens 16 executes a process, such as its "Cell Differentiation" feature, to identify a plurality of cells from the slide image. | ¶32 | col. 5:1-5 |
| (E) analyzing the plurality of cells with at least one cell classification algorithm... in order to identify a tumor cell percent positivity value and an immune cell percent positivity value | The HemoLens 16 analyzes cells to identify abnormal cells (e.g., anemias, sickle cells, myeloproliferative syndrome) and immune cells (lymphocytes, WBCs), which allegedly constitutes identifying tumor and immune cell positivity values. | ¶33 | col. 5:5-9 |
| (F) calculating a treatment efficacy score from the tumor cell percent positivity value and the immune cell percent positivity value | On information and belief, the HemoLens 16 is configured to provide a report that includes a "treatment efficacy score or its equivalent" based on its cell differentiation results. | ¶34 | col. 5:9-12 |
- Identified Points of Contention:
- Technical Questions: The complaint alleges the accused HemoLens 16 identifies a "tumor cell percent positivity value" by identifying "a variety of abnormal cells including at least anemias, sickle cells, poikilocytosis, myeloproliferative syndrome..." (Compl. ¶33). A central dispute will be whether identifying these specific hematological conditions is technically equivalent to identifying a "tumor cell percent positivity value" as contemplated by a patent focused on immuno-oncology. A screenshot shows the accused product's user interface displaying percentages of classified cell types (Compl. p. 19, ¶33).
- Evidentiary Questions: The allegation for calculating a "treatment efficacy score" is made "on information and belief" and suggests the feature may be an "equivalent" (Compl. ¶34). This raises the question of whether this functionality is explicitly present in the accused product or is an inference by the plaintiff that will require significant support from discovery.
V. Key Claim Terms for Construction
For the ’365 Patent:
- The Terms: "slide basket transfer assembly" and "slide transfer assembly"
- Context and Importance: These terms are central because the complaint alleges they are met by different functions of what appears to be a single robotic system in the accused product. The viability of the infringement claim may depend on whether these terms require two structurally separate apparatuses or can be read functionally to cover different operations of one integrated system. Practitioners may focus on this distinction as a primary non-infringement defense.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader (Functional) Interpretation: The patent's abstract distinguishes the assemblies by their function: one "retrieves the basket" while the other "retrieves a single slide from the basket" ('365 Patent, Abstract). This functional language could support an argument that any components performing these distinct tasks meet the limitations, regardless of physical integration.
- Evidence for a Narrower (Structural) Interpretation: The patent’s detailed description and figures describe and depict the "slide basket transfer assembly" (Fig. 3) and "slide transfer assembly" (Fig. 4) as distinct, separate mechanical systems (’365 Patent, col. 4:5-8, col. 5:1-4). This could support a construction requiring two physically separate structures.
For the ’376 Patent:
- The Term: "tumor cell percent positivity value"
- Context and Importance: This term is critical because the accused product is marketed for "AI-enabled Cell Differentiation," identifying various blood cell types and abnormalities (Compl. p. 17). The infringement case hinges on whether this functionality equates to identifying a "tumor cell percent positivity value".
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification refers generally to quantifying "cancer cells based on biomarker content" ('376 Patent, col. 2:5-6). Plaintiff may argue that some abnormalities identified by the accused product (e.g., myeloproliferative syndrome) are cancers, and thus their quantification meets this limitation.
- Evidence for a Narrower Interpretation: The patent’s background discusses its context in "immuno-oncology" and the "tumor microenvironment" ('376 Patent, col. 1:26-32), which often relates to solid tumors. Defendant may argue the term should be limited to that context and not read on the hematological analyses allegedly performed by the accused product.
VI. Other Allegations
- Indirect Infringement: For the '376 method patent, the complaint alleges inducement to infringe, asserting that Defendant's actions have been willful and will continue to injure Optrascan (Compl. ¶38).
- Willful Infringement: The complaint alleges that Defendant had pre-suit knowledge of both patents and their infringement "no later than November 17, 2022" (Compl. ¶¶14, 30). It is alleged that despite this notice, Defendant continued its infringing activities, which forms the basis for the willfulness claim (Compl. ¶¶23-24, 36-37).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue for the '376 patent will be one of definitional scope: can the term "tumor cell percent positivity value", described in the patent's context of immuno-oncology, be construed to cover the AI-driven identification of hematological abnormalities and white blood cell differentiation performed by the accused HemoLens product?
- A key structural question for the '365 patent will be whether the accused MorphoLens 240's integrated robotic system can satisfy the claim limitations for two distinct apparatuses—a "slide basket transfer assembly" and a "slide transfer assembly"—or if the claims require physically separate components.
- A central evidentiary question will pervade the case: does discovery evidence show that the accused products actually perform the specific functions alleged, particularly the calculation of a "treatment efficacy score" in the '376 patent, which the complaint pleads "on information and belief" and as a potential "equivalent"?