DCT

0:15-cv-03006

Sorna Corp v. Carestream Health Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 0:15-cv-03006, D. Minn., 07/08/2015
  • Venue Allegations: Venue is alleged based on Defendant’s continuous and systematic contacts within Minnesota, including the presence of a facility and office, as well as the offer for sale and sale of accused products in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s CD Direct Suite, a product for creating medical image discs, infringes four patents related to automated systems for recording medical data onto portable media and printing corresponding labels.
  • Technical Context: The technology addresses the workflow of creating and managing portable physical copies of digital medical records (e.g., DICOM images on CDs/DVDs) for use in hospitals, clinics, and doctors' offices.
  • Key Procedural History: The complaint alleges that the parties discussed licensing the patents-in-suit as early as January 2014. An Inter Partes Review (IPR2019-00218) was subsequently filed against the ’408 patent, with the Patent Trial and Appeal Board ultimately issuing a certificate on March 21, 2022, confirming the patentability of all challenged claims (1-19). This IPR outcome may reinforce the ’408 patent’s presumption of validity.

Case Timeline

Date Event
2000-05-19 Earliest Priority Date for '408, ’214, ’304, and ’226 Patents
2003-01-01 Alleged knowledge of Sorna's products by Defendant's former parent company
2011-06-21 U.S. Patent No. 7,965,408 Issues
2011-10-25 U.S. Patent No. 8,045,214 Issues
2011-11-15 U.S. Patent No. 8,059,304 Issues
2014-01-01 Alleged licensing discussions and written notice of patent rights
2014-04-01 U.S. Patent No. 8,687,226 Issues
2015-07-08 Complaint Filed
2022-03-21 Inter Partes Review Certificate Issued for '408 Patent

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

U.S. Patent No. 7,965,408 - “Medical Data Recording System,” issued June 21, 2011

The Invention Explained

  • Problem Addressed: The patent’s background section describes the process of manually storing medical imaging data on CDs for filing as a "labor-intensive and error-prone task" that required staff to gather information, write out labels, and attach them to discs. (’408 Patent, col. 1:30-34).
  • The Patented Solution: The invention is a method for an automated system that receives medical data in a standard format (DICOM), parses key patient and study information from that data, and uses that information to automatically burn a disc and print a corresponding label with the relevant details. (’408 Patent, Abstract; col. 2:38-44). The system is described as using an "autoloader" to physically handle the blank and recorded discs. (’408 Patent, col. 2:48-52).
  • Technical Importance: This technology sought to automate and streamline the workflow for creating portable patient records on physical media, aiming to reduce clerical time and the potential for human error in medical facilities. (’408 Patent, col. 1:15-18).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" (Compl. ¶35). Independent claims 1 and 14 appear representative of the core invention.
  • Independent Claim 1 (Method) Essential Elements:
    • Receiving medical data in DICOM format and parsing patient/study information.
    • Storing the parsed information and the DICOM image information.
    • "Noting the end of the received medical data information" for each patient.
    • Creating a "job" containing medical data and viewing software.
    • Providing print information for an "autoloader control software."
    • Submitting the job to the autoloader control software.
    • Recording the DICOM images, viewing software, and other files onto a recording medium.
    • "Automatically printing the selected fields" from the parsed information onto the recording medium to create a label.

U.S. Patent No. 8,045,214 - “Medical Data Recording Apparatus,” issued October 25, 2011

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as its parent '408 patent: the inefficient and error-prone manual process of creating and labeling physical media containing medical images. (’214 Patent, col. 1:38-44).
  • The Patented Solution: This patent claims the apparatus for performing the automated recording and labeling process, rather than the method itself. The claims are structured in a means-plus-function format, claiming a series of "means for" accomplishing the core tasks of receiving, parsing, storing, job creation, recording, and printing. (’214 Patent, Abstract; col. 7:14-col. 8:1). The specification describes the hardware as including a computer server, a CD autoloader with a printer, and a piracy prevention device. (’214 Patent, col. 1:60-63).
  • Technical Importance: By claiming the apparatus, this patent provides a different scope of protection for the same underlying automated system, focused on the structure of the machine rather than the steps of its use.

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" (Compl. ¶41). Independent claims 1, 16, 26, and 31 are asserted.
  • Independent Claim 1 (Apparatus) Essential Elements:
    • "means for receiving medical data information in DICOM format" and parsing patient/study information.
    • "means for storing" the parsed information and DICOM images.
    • "means for noting the end of the received medical data information."
    • "means for creating a job."
    • "means for providing print information for an autoloader control software."
    • "means for submitting the job to the autoloader control software."
    • "means for recording" the DICOM images and other files.
    • "means for automatically printing the selected fields" to label the media.

U.S. Patent No. 8,059,304 - “Medical Data Recording System,” issued November 15, 2011

  • Technology Synopsis: This patent claims a "non-transitory machine-readable medium" (e.g., a software product) containing instructions that, when executed, cause a machine to perform the same core automated process of receiving DICOM data, parsing it, creating a job, and automatically burning and labeling a disc. (’304 Patent, Abstract; cl. 1). It covers the software that drives the system.
  • Asserted Claims: "one or more of the claims of the ’304 patent" (Compl. ¶47). Independent claims 1 and 8 are representative.
  • Accused Features: The accused "CD Direct Suite" software product, which allegedly contains the instructions to carry out the claimed steps. (Compl. ¶13).

U.S. Patent No. 8,687,226 - “Medical Data Recording System,” issued April 1, 2014

  • Technology Synopsis: This patent claims a method and system for medical data recording, again covering the core invention of receiving DICOM data, extracting patient/study information, creating a job for a "record and print control software," and automatically labeling the resulting media. (’226 Patent, Abstract; cl. 1, 32). The claims appear to be a continuation of the same inventive concept.
  • Asserted Claims: "one or more of the claims of the ’226 patent" (Compl. ¶53). Independent claims 1, 18, 32, 41 and 42 are representative.
  • Accused Features: The accused "CD Direct Suite" product and its functionality for creating and labeling discs with medical data. (Compl. ¶¶13-17).

III. The Accused Instrumentality

Product Identification

  • Carestream's CD Direct Suite (Compl. ¶13).

Functionality and Market Context

  • The complaint alleges the CD Direct Suite is a software product that allows users to "create discs (CDs or DVDs) containing medical image data" (Compl. ¶14). The functionality is described as retrieving DICOM images from third-party PACS, burning the images and a viewer to a disc, and printing labels for the disc. (Compl. ¶¶14, 16, 17). The user can "select studies to be burned onto a cd" (Compl. ¶15). The complaint alleges the product directly competes with Sorna's own devices. (Compl. ¶20).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart exhibit. The following summary is constructed from the narrative allegations.

’408 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
receiving medical data information in DICOM format through a software module and parsing patient identification information and study information... The infringing products are configured to retrieve images from any DICOM modality and import image from a third-party PACS. ¶16 col. 5:61-64
storing DICOM image information coming from the one or more files... The infringing products allow a user to select studies to be burned onto a disc, which contains the original, uncompressed DICOM images. ¶¶14-15 col. 6:2-5
creating a job containing medical data for a patient, and medical data image viewing software... The accused product creates discs containing medical image data along with a viewer. ¶14 col. 7:4-8
providing print information for an autoloader control software... The infringing products are configured to print labels on the burned media and configure data to appear on the labels. ¶17 col. 5:35-44
automatically printing the selected fields of the automatic scan of the stored parsed patient identification information... on the recording media to label the recording media. The infringing products are configured to print labels on the burned media and configure what data appears on those labels. ¶17 col. 5:53-59

Identified Points of Contention

  • Scope Questions: The complaint alleges Carestream argued it cannot infringe because it "does not manufacture a CD drive or burner" (Compl. ¶25). This raises the question of whether Carestream’s software-only product meets the claim limitations for an "autoloader control software" and a fully automated system, as the patents heavily describe an integrated hardware apparatus (’408 Patent, Fig. 1).
  • Technical Questions: The claims require "noting the end of the received medical data information... for each patient," which the patent specification discloses as an automated "end-of-patient-data timeout" (’408 Patent, col. 3:55-65). It is an open question whether the accused product, which allows a "user to select studies to be burned" (Compl. ¶15), performs this specific automated step or relies on manual user definition of the job, which may not satisfy the claim limitation.

V. Key Claim Terms for Construction

The Term: "autoloader control software" (’408 Patent, cl. 1)

  • Context and Importance: This term is critical because Defendant’s alleged position is that it does not manufacture hardware and thus cannot infringe (Compl. ¶25), while the patent's embodiments describe a physically integrated system with a robotic autoloader (’408 Patent, Fig. 1). The definition will determine whether a software-only product that interfaces with third-party hardware can infringe.
  • Intrinsic Evidence for a Broader Interpretation: The claim requires "providing print information for an autoloader control software," which could be interpreted to mean the claimed method prepares information for use by such software, without requiring the method itself to be part of that software or to be practiced on a single integrated device.
  • Intrinsic Evidence for a Narrower Interpretation: The specification explicitly describes the autoloader control software as "Buzzsaw®," which "instructs the autoloader 46 to pick up a new CDR 42, put it in the CDR drive 40," suggesting direct control over physical hardware components. (’408 Patent, col. 5:45-48).

The Term: "noting the end of the received medical data information through the software module for each patient" (’408 Patent, cl. 1)

  • Context and Importance: This term defines a key automation step. Infringement may turn on whether the accused product performs this step automatically, as described in the patent, or relies on manual user intervention.
  • Intrinsic Evidence for a Broader Interpretation: A party could argue that any process of finalizing a set of data for a patient, such as a user clicking "finish," constitutes "noting the end" of the data receipt.
  • Intrinsic Evidence for a Narrower Interpretation: The specification discloses a specific mechanism for this step: an "end-of-patient-data timeout (MaxTime)" where the system waits a configurable period (e.g., 30 seconds) after the last file is received before deeming the patient's data stream complete. (’408 Patent, col. 3:55-65). This specific embodiment may be used to argue for a narrower construction limited to a time-based, automated determination.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe based on Defendant providing "ongoing maintenance and support services" with knowledge that this encourages customers to use the product in an infringing manner (Compl. ¶¶32-33, 88). Contributory infringement is alleged based on knowledge of the patents and the assertion that the accused product has no "substantially non-infringing uses" (Compl. ¶¶72-73).
  • Willful Infringement: Willfulness is alleged based on pre-suit knowledge of the patents, stemming from licensing discussions that allegedly began in January 2014 (Compl. ¶¶23-24, 59).

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

  • A core issue will be one of system scope: Can Sorna prove that Carestream’s "CD Direct Suite" software, which is allegedly sold with third-party burners, infringes claims directed to an automated system with an "autoloader control software," when the patent specifications heavily feature a physically integrated hardware apparatus?
  • A key evidentiary question will be one of functional operation: Does the accused product’s method of defining a recording job, which involves a "user to select studies," meet the specific claim requirement of automatically "noting the end of the received medical data... for each patient," or does this reliance on user input create a functional mismatch with the automated timeout process described in the patents?