DCT
1:23-cv-00733
Optrascan Inc v. Morphle Labs Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Optrascan Inc (California)
- Defendant: Morphle Labs Inc (India)
- Plaintiff’s Counsel: Entralta P.L.L.C.; Bourland, Wall & Wenzel, P.C.
- Case Identification: 1:23-cv-00733, W.D. Tex., 10/10/2023
- Venue Allegations: Plaintiff alleges venue is proper in the Western District of Texas based on Defendant’s sale of an allegedly infringing slide reader to a customer, Clinical Pathology Associates, located in Austin, Texas. The complaint further asserts that Defendant, an Indian corporation, lacks a permanent and continuous presence elsewhere in the United States.
- Core Dispute: Plaintiff alleges that Defendant’s digital pathology slide scanners and associated analysis software infringe two patents related to the automated mechanical handling of microscope slides and the automated analysis of slide images to predict immunotherapy efficacy.
- Technical Context: The lawsuit concerns the field of digital pathology, where physical microscope slides are converted into high-resolution digital images for analysis, a market driven by the need for higher throughput and more consistent diagnostic results.
- Key Procedural History: The complaint alleges that Plaintiff provided Defendant with written notice of the alleged infringement on November 17, 2022, nearly a year before filing the amended complaint. This date is foundational to the claim for willful infringement.
Case Timeline
| Date | Event |
|---|---|
| 2016-08-24 | U.S. Patent No. 10,338,365 Priority Date |
| 2017-06-13 | U.S. Patent No. 10,586,376 Priority Date |
| 2019-07-02 | U.S. Patent No. 10,338,365 Issue Date |
| 2020-03-10 | U.S. Patent No. 10,586,376 Issue Date |
| 2022-11-17 | Plaintiff provides written notice of infringement to Defendant |
| 2023-10-10 | 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 describes the process of manually loading microscope slides for analysis as a bottleneck in pathology diagnostics. It notes that while some automated systems exist, there remains a need for a slide handling mechanism that is "robust, automated, accurate, simple to use, low cost and scalable" and can handle slides of varying thicknesses ('365 Patent, col. 2:8-14).
- The Patented Solution: The invention proposes a comprehensive, multi-stage robotic system to fully automate the slide handling process. As illustrated in the operational diagram of FIG. 6, the system comprises a carousel-like "slide storage assembly" (100) to hold multiple "slide baskets" (20), a "slide basket transfer assembly" (200) to retrieve an entire basket, and a separate "slide transfer assembly" (300) to pick an individual slide from that basket and deliver it to the "slide scanning stage" (400) for imaging ('365 Patent, Abstract; col. 2:51-col. 3:2).
- Technical Importance: The technology aims to significantly increase the throughput and efficiency of digital slide scanning, a critical step in modernizing pathology workflows ('365 Patent, col. 1:26-34).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 and dependent Claims 7 and 8 (Compl., Ex. A, pp. 9-13).
- Independent Claim 1 requires a system comprising:
- A slide scanning stage configured to receive and move a slide for scanning.
- A slide storage assembly to store at least one slide basket, which in turn stores a plurality of slides.
- A slide basket transfer assembly to retrieve and store the slide basket from the storage assembly.
- A slide transfer assembly to retrieve an individual slide from the basket, deliver it to the scanning stage, and return it.
- A slide basket holder (part of the basket transfer assembly) configured for vertical movement along a Z axis.
- A support base (part of the slide transfer assembly) configured for horizontal movement in an X-Y plane.
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 identifies a challenge in immuno-oncology: evaluating multiple immune-biomarkers to predict a patient's response to therapy is complex, often manual, and lacks a single, integrated platform that supports "whole slide scanning, registration, segmentation and quantification of cancer cells based on biomarker content" ('376 Patent, col. 2:2-6).
- The Patented Solution: The invention claims an automated method that uses a connected slide scanner and processing device. The method involves acquiring a digital image of a tissue sample, executing a cell segmentation process to identify cells, analyzing those cells with a classification algorithm to determine "a tumor cell percent positivity value and an immune cell percent positivity value," and finally "calculating a treatment efficacy score" based on those values ('376 Patent, Abstract; FIG. 1).
- Technical Importance: The method provides a consolidated digital tool to automate immuno-oncology analytics, potentially leading to more accurate and reproducible assessments of whether a patient will respond to certain cancer treatments ('376 Patent, col. 2:50-54).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 and dependent Claims 2, 4, 5, 6, and 11 (Compl., Ex. B, pp. 15-20).
- Independent Claim 1 requires a method comprising the steps of:
- (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 on the image 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.
- (F) Calculating a treatment efficacy score from the tumor and immune cell positivity values.
III. The Accused Instrumentality
Product Identification
- The complaint names the "Morpholens 6, Morpholens 240 and Hemolens" slide readers as the accused instrumentalities (Compl. ¶15). The infringement allegations focus on the MorphoLens 240 and Hemolens products.
Functionality and Market Context
- The MorphoLens 240 is presented as a high-throughput digital slide scanner capable of "Batch Loading" up to 240 slides contained in multi-slide cassettes (Compl., Ex. A, p. 10). A promotional video screenshot shows a large-capacity slide loading mechanism, which the complaint alleges is the infringing "slide storage assembly" (Compl., Ex. A, p. 10). The complaint further alleges the device uses a robotic system to retrieve cassettes and individual slides for scanning under a microscope objective (Compl., Ex. A, p. 11).
- The Hemolens is described as a system featuring "AI-enabled Cell Differentiation" for analyzing slide images (Compl., Ex. B, p. 16). A marketing graphic depicts a workflow of "Walk-away Scanning," AI-based cell classification, and "Tele-reported by Specialists" (Compl., Ex. B, p. 16). The complaint alleges this functionality performs the automated analysis method of the ’376 Patent.
- The complaint highlights a testimonial from a customer in Austin, Texas, to establish the products' use in the district and their commercial role in enabling "effective tele-reporting" and reducing case turnaround times (Compl. ¶¶11-13).
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 and move the slide holder in relation to the microscope objective in order to scan the slide; | The MorphoLens 240 provides a scanning stage that receives a slide and moves it via a lead screw for scanning. A screenshot from a promotional video is provided as evidence (Compl., Ex. A, p. 11). | ¶14 | col. 2:51-56 |
| 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 has a housing that stores slide cassettes, which are alleged to be the claimed "slide basket," each holding multiple slides. A screenshot shows a "240 Slides Batch Loading" feature (Compl., Ex. A, p. 10). | ¶14 | col. 2:57-60 |
| a slide basket transfer assembly configured to retrieve and store the at least one slide basket from and into the slide storage assembly, respectively; | The accused system includes an assembly that grips and retrieves a slide cassette from the storage housing for scanning and returns it afterward. | ¶14 | col. 2:61-63 |
| 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 system has an assembly, allegedly integrated with the basket transfer assembly, to retrieve an individual slide from the cassette and deliver it to the scanning stage. | ¶14 | col. 2:64-3:2 |
| a slide basket holder of the slide basket transfer assembly being configured to move vertically along a Z axis in order to transfer a slide basket...; | The system’s basket holder is alleged to move vertically to transfer a cassette from the storage housing. The complaint states this vertical movement is "inherent" to the operation (Compl., Ex. A, p. 11). | ¶14 | col. 4:11-16 |
| a support base of the slide transfer assembly being configured to move horizontally in an X-Y plane in order to transfer a slide from the slide basket transfer assembly to the slide scanning stage...; | The assembly that transfers individual slides is alleged to be configured to move horizontally in an X-Y plane to deliver the slide to the scanning stage. | ¶14 | col. 6:1-8 |
Identified Points of Contention
- Scope Questions: A central question will be whether the accused "slide cassette" falls within the scope of the claimed "slide basket." The complaint alleges they are "functionally equivalent" (Compl., Ex. A, p. 10), which suggests this may be a dispute under the doctrine of equivalents or a claim construction issue.
- Technical Questions: The complaint alleges that the vertical movement of the slide basket holder is "inherent" in the device's operation (Compl., Ex. A, p. 11). This raises an evidentiary question of whether the accused product actually performs this claimed function or if Plaintiff is inferring the function from the device's overall design.
'376 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (A) providing an automated slide scanning system and a processing device, wherein the automated slide scanning system comprises an image acquisition unit, and wherein the automated slide scanning system is electronically connected to the processing device; | The Hemolens product is an automated slide scanning system with an image acquisition unit and a processing device for "AI-enabled cell differentiation" (Compl., Ex. B, p. 16). | ¶14 | col. 3:52-58 |
| (B) receiving a sample slide through the automated slide scanning system, wherein a tissue sample is mounted to the sample slide; | The Hemolens system is shown to receive a single slide with "soft sideways clamping" (Compl., Ex. B, p. 17). | ¶14 | col. 3:58-61 |
| (C) acquiring at least one slide image of the tissue sample through the image acquisition unit; | The product website describes acquiring slide images as part of its "All-Digital Workflow" (Compl., Ex. B, p. 17). | ¶14 | col. 3:62-65 |
| (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 system is alleged to execute cell segmentation, as its marketing states "120 WBCs are classified, sorted & flagged" and "Abnormal cells are pre-flagged and sorted" (Compl., Ex. B, p. 17). | ¶14 | col. 5:2-6 |
| (E) analyzing the plurality of cells with at least one cell classification algorithm... to identify a tumor cell percent positivity value and an immune cell percent positivity value; | The complaint alleges that the "AI-enabled cell differentiation" and classification of cells inherently comprises an analysis to identify tumor and immune cell positivity values. A screenshot shows image filtering processes being applied (Compl., Ex. B, p. 20). | ¶14 | col. 5:7-12 |
| (F) calculating a treatment efficacy score from the tumor cell percent positivity value and the immune cell percent positivity value. | The complaint alleges that the Hemolens system calculates a treatment efficacy score from the identified positivity values. | ¶14 | col. 5:12-15 |
Identified Points of Contention
- Technical Questions: The infringement theory for step (F), "calculating a treatment efficacy score," may be a key point of dispute. The complaint's evidence shows the Hemolens system classifies and flags cells for "Tele-reported by Specialists" (Compl., Ex. B, p. 17). This raises the question of whether the accused system itself performs the claimed "calculating" step, or if it merely provides the underlying data for a human pathologist to perform the final calculation and assessment.
V. Key Claim Terms for Construction
For the '365 Patent
- The Term: "slide basket"
- Context and Importance: This term is critical because the complaint alleges the accused "slide cassette" is a "slide basket." The viability of the infringement claim may depend on whether the term is construed broadly to encompass any multi-slide holder or narrowly to require specific structural features shown in the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states that a "slide basket 20 is configured to hold a plurality of slides 10" ('365 Patent, col. 3:8-10), a general description that could plausibly cover a standard cassette.
- Evidence for a Narrower Interpretation: The patent depicts the "slide basket" as interacting with a specific carousel system via a "slot base" (126) and arms (124, 125) ('365 Patent, col. 3:57-64; FIG. 2). A court may be asked to decide if these features are essential limitations of the term.
For the '376 Patent
- The Term: "calculating a treatment efficacy score"
- Context and Importance: This is the final, dispositive step of the claimed method. Practitioners may focus on this term because the infringement case hinges on whether the accused Hemolens system performs this calculation itself or simply provides data for a human to do so.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not define "score" with a specific formula, stating only that it is calculated from the previously identified positivity values ('376 Patent, col. 5:12-15). This could support an argument that any automated output derived from those values meets the limitation.
- Evidence for a Narrower Interpretation: The active verb "calculating" implies an automated computation of a final, distinct value. The patent's goal is to predict "the probability a given patient will respond positively" ('376 Patent, col. 3:4-6). If the accused system only sorts and flags cells for subsequent human review, an argument could be made that it does not perform the claimed calculation step.
VI. Other Allegations
- Indirect Infringement: The complaint pleads inducement to infringe (Compl. ¶18, misnumbered as 14). The factual basis appears to rest on Defendant's sale of the accused products along with marketing materials, such as the demo videos and product websites cited in the claim charts, which allegedly instruct customers on how to use the products in an infringing manner.
- Willful Infringement: The complaint alleges willful infringement based on Defendant's continued infringing activities after receiving written notice from Optrascan Inc on November 17, 2022 (Compl. ¶¶14-17). This allegation of pre-suit knowledge provides a direct factual basis for the willfulness claim.
VII. Analyst’s Conclusion: Key Questions for the Case
This dispute appears to center on two distinct types of patent questions, one mechanical and one computational. The key issues for the court will likely be:
- A core issue will be one of definitional scope: can the term "slide basket," which is described in the '365 patent with specific structural interactions, be construed to read on the accused product's "slide cassette," and does the evidence show that the accused device performs the exact sequence of mechanical movements claimed?
- A key evidentiary question will be one of functional performance: does the accused Hemolens product's "AI-enabled Cell Differentiation" software perform the specific, claimed step of "calculating a treatment efficacy score" as required by the '376 patent, or does it stop short by merely presenting analyzed data for a human specialist to interpret and assess?