DCT
0:16-cv-01748
Sorna Corp v. PACS Exchange
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Sorna Corporation (Minnesota)
- Defendant: PACS-Exchange, LLC (Wisconsin)
- Plaintiff’s Counsel: F.S. FARRELL, LLC
- Case Identification: 0:16-cv-01748, D. Minn., 05/27/2016
- Venue Allegations: Venue is alleged to be proper in the District of Minnesota based on Defendant's continuous and systematic contacts with the state, including offering to sell and selling the accused products in Minnesota.
- Core Dispute: Plaintiff alleges that Defendant’s medical data recording software and devices infringe four patents related to systems and methods for automatically recording medical imaging data onto portable media and printing patient-specific labels on the media.
- Technical Context: The technology addresses the workflow for managing digital medical images (e.g., DICOM files) by automating the process of burning patient studies to CDs or DVDs and labeling them for archival and distribution.
- Key Procedural History: U.S. Patent No. 7,965,408, the first-listed patent-in-suit, was the subject of an Inter Partes Review (IPR2019-00218). In a certificate issued March 21, 2022, the U.S. Patent and Trademark Office confirmed that all claims (1-19) were patentable. This proceeding may bolster the patent's presumption of validity against challenges based on prior art that was considered during the IPR.
Case Timeline
| Date | Event |
|---|---|
| 2000-05-19 | Earliest Priority Date for all Patents-in-Suit |
| 2011-06-21 | U.S. Patent No. 7,965,408 Issued |
| 2011-10-25 | U.S. Patent No. 8,045,214 Issued |
| 2011-11-15 | U.S. Patent No. 8,059,304 Issued |
| 2014-04-01 | U.S. Patent No. 8,687,226 Issued |
| 2016-05-27 | Complaint Filed |
| 2018-11-08 | Inter Partes Review (IPR2019-00218) Filed for '408 Patent |
| 2022-03-21 | IPR Certificate Issued for '408 Patent; Claims Confirmed |
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 describes the process of manually recording medical imaging data onto portable media like CDs as a "labor-intensive and error-prone task" that involves gathering information, writing out labels, and attaching them to discs (’408 Patent, col. 1:30-33).
- The Patented Solution: The invention is a method for automating this process. It involves a system that electronically receives medical data in a standard format (DICOM), parses patient and study information, and determines when the data stream for a single patient is complete ('408 Patent, col. 3:55-65). It then creates a "job" to record the patient’s images and a medical image viewer onto a disc, and automatically prints selected patient data directly onto the disc’s surface using an integrated autoloader and printer ('408 Patent, Abstract; col. 1:57-66).
- Technical Importance: The technology sought to streamline clinical workflows by reducing the manual clerical time and potential for human error associated with archiving and distributing digital medical studies ('408 Patent, col. 2:16-18).
Key Claims at a Glance
- The complaint asserts "one or more of the claims" without specifying which ones (Compl. ¶17). Independent claim 1 is a method claim.
- The essential elements of independent claim 1 include:
- receiving medical data in DICOM format and parsing patient/study information;
- storing the parsed information and DICOM images;
- noting the end of the received medical data for each patient;
- creating a job containing the patient's data and a medical image viewer;
- providing print information with selected fields to an autoloader control software;
- submitting the job to the software to record the data and viewer onto a recording medium; and
- automatically printing the selected fields onto the medium to label it.
- The complaint does not explicitly reserve the right to assert dependent claims.
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 inefficiencies as the ’408 Patent: the expensive, bulky, and error-prone nature of managing medical images, whether on film or through manual digital recording processes (’214 Patent, col. 1:24-48).
- The Patented Solution: This patent claims an apparatus or system for performing the automated recording and labeling functions. The claims are drafted in a means-plus-function format under 35 U.S.C. § 112(f), reciting a series of "means for" performing the core steps of the invention, such as "means for receiving medical data," "means for creating a job," and "means for automatically printing." (’214 Patent, Abstract; col. 7:13 - col. 8:2). The specification provides corresponding structures, such as specific software routines and hardware components like a computer server and CD autoloader, that perform these functions (’214 Patent, col. 2:50-54; Fig. 1).
- Technical Importance: By claiming an apparatus, the patent provides a different scope of protection than the method claims of the ’408 Patent, covering the integrated system itself.
Key Claims at a Glance
- The complaint asserts "one or more of the claims" (Compl. ¶23). Independent claim 1 is an apparatus claim.
- The essential elements of independent claim 1 are a series of "means for" performing functions that largely mirror the method steps of claim 1 of the '408 Patent, including:
- means for receiving and parsing DICOM data;
- means for storing the data;
- means for noting the end of a patient's data transmission;
- means for creating and submitting a job to autoloader software;
- means for recording the data and a viewer to media; and
- means for automatically printing a label on the media.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,059,304 - Medical Data Recording System
- Patent Identification: U.S. Patent No. 8,059,304, issued November 15, 2011 (Compl. ¶10).
- Technology Synopsis: This patent claims a non-transitory machine-readable medium (e.g., software) containing instructions that, when executed, cause a machine to perform the automated process of receiving, parsing, recording, and labeling medical data on portable media. It protects the software that embodies the automated workflow (’304 Patent, Abstract; col. 7:5-41).
- Asserted Claims: The complaint asserts "one or more of the claims" (Compl. ¶29). Independent claims 1 and 8 are asserted.
- Accused Features: The accused software products are alleged to contain the executable instructions for performing the patented method (Compl. ¶¶13-14).
U.S. Patent No. 8,687,226 - Medical Data Recording System
- Patent Identification: U.S. Patent No. 8,687,226, issued April 1, 2014 (Compl. ¶11).
- Technology Synopsis: This patent family member provides further protection for the invention, with claims directed to a non-transitory machine-readable medium, a method, and a system for performing the automated medical data recording and labeling workflow (’226 Patent, Abstract; col. 7:12-44).
- Asserted Claims: The complaint asserts "one or more of the claims" (Compl. ¶35). Independent claims 1, 18, 32, 41, and 42 are asserted.
- Accused Features: The accused software and devices are alleged to constitute the system, perform the method, and embody the machine-readable instructions for CD/DVD publishing and labeling (Compl. ¶¶13-14).
III. The Accused Instrumentality
Product Identification
- The complaint identifies "PACS-Exchange's PACS Express, PACS Exporter and PACS Executive products" as the infringing instrumentalities (Compl. ¶13).
Functionality and Market Context
- The products are described as "medical data recording software and devices" (Compl. ¶13).
- Their functionality is alleged to include "CD/DVD publishing of reports and studies, custom labeling with patient study specific information printed on the disc, and the inclusion of a medical image viewer on the disc" (Compl. ¶14).
- The complaint does not provide further detail on the technical operation or market positioning of the accused products.
IV. Analysis of Infringement Allegations
The complaint does not include detailed, element-by-element infringement contentions or claim charts. The allegations are based on a high-level description of the accused products' functionality. No probative visual evidence provided in complaint.
’408 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| receiving medical data information in DICOM format...and parsing patient identification information and study information... | "[M]edical data recording software and devices" designed for "CD/DVD publishing of reports and studies..." | ¶13-14 | col. 1:47-51 |
| noting the end of the received medical data information through the software module for each patient, | The complaint does not provide sufficient detail for analysis of this element. | ¶13-14 | col. 3:61-65 |
| creating a job containing medical data for a patient, and medical data image viewing software... | "[D]esigned CD/DVD publishing of reports and studies... and the inclusion of a medical image viewer on the disc." | ¶14 | col. 1:57-63 |
| providing print information for an autoloader control software, the print information having selected fields... | "[C]ustom labeling with patient study specific information printed on the disc..." | ¶14 | col. 5:35-44 |
| recording said DICOM image information from the one or more files on a recording media...and recording...the medical data image viewing software... | "[D]esigned CD/DVD publishing of reports and studies... and the inclusion of a medical image viewer on the disc." | ¶14 | col. 1:53-56 |
| automatically printing the selected fields of the...stored parsed study information on the recording media to label the recording media. | "[C]ustom labeling with patient study specific information printed on the disc..." | ¶14 | col. 1:63-66 |
’214 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| means for receiving medical data information in DICOM format... | "[M]edical data recording software and devices" that perform "CD/DVD publishing of reports and studies." | ¶13-14 | col. 7:13-19 |
| means for noting the end of the received medical data...for each patient, | The complaint does not provide sufficient detail for analysis of this element. | ¶13-14 | col. 7:29-32 |
| means for creating a job containing medical data...and...viewing software, | Products designed for "CD/DVD publishing" and "inclusion of a medical image viewer on the disc." | ¶14 | col. 7:33-43 |
| means for automatically printing the selected fields...to label the media. | Functionality for "custom labeling with patient study specific information printed on the disc." | ¶14 | col. 7:45 - 8:2 |
Identified Points of Contention
- Evidentiary Questions: As the complaint provides only a high-level product description, a central issue will be whether discovery produces evidence that the accused products in fact perform every step of the asserted method claims or contain structure corresponding to every "means for" limitation of the apparatus claims.
- Technical Questions: A key technical question for the method patents (’408, ’304, ’226) is how the accused system achieves the "noting the end of the received medical data... for each patient" step. The patents disclose a "time out period" (’408 Patent, col. 3:61-65). The degree to which the accused system’s functionality matches this disclosed mechanism will be a likely point of dispute.
- Scope Questions (Means-Plus-Function): For the ’214 Patent, the analysis will turn on claim construction under 35 U.S.C. § 112(f). The court will need to identify the specific structures disclosed in the specification that perform the functions recited in the "means for" limitations. Infringement will require a showing that the accused devices perform the identical function using a structure that is either identical or equivalent to the disclosed structures.
V. Key Claim Terms for Construction
"noting the end of the received medical data information... for each patient" (’408 Patent, cl. 1)
- Context and Importance: This limitation defines the trigger for converting an incoming data stream into a discrete, patient-specific "job" for recording. Its construction is critical because if the accused system uses a technically different method to delineate patient studies, it may not infringe.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue the plain language does not require a specific mechanism, only that the system has some way of determining that a given patient's data transfer is complete.
- Evidence for a Narrower Interpretation: The specification discloses a specific implementation: an "end-of-patient-data timeout (MaxTime) 65" (’408 Patent, col. 3:61-65). A party could argue that this disclosure limits the scope of the claim term to a timeout-based mechanism or its equivalents, potentially excluding systems that rely on other triggers (e.g., an explicit "end-of-study" command from the source modality).
"means for creating a job" (’214 Patent, cl. 1)
- Context and Importance: As a means-plus-function limitation, its scope is defined by the corresponding structure in the specification. The interpretation of this structure will be central to the infringement analysis for the ’214 Patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation (Function): The function is creating a self-contained package of data for recording, including patient images, a viewer, and label information.
- Evidence for a Narrower Interpretation (Structure): The specification discloses specific software routines and file structures as the corresponding structure. This includes converting file names to an eight-character format, creating specific directories (e.g., "PT000000"), and generating files like "Patient.txt" and "DICOMDIR" in a "Build Image Directory" (’214 Patent, col. 5:1-30). A defendant could argue that an accused system must use an identical or equivalent file-and-directory structuring process to meet this limitation.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement claims are based on allegations that Defendant sells the products knowing they will be used by customers to directly infringe (Compl. ¶¶73-74). The contributory infringement claims are based on allegations of knowledge and the assertion that the products "do not have any other substantially non-infringing uses" (Compl. ¶¶53, 56).
- Willful Infringement: The complaint alleges that Defendant’s infringement was "deliberate and willful given PACS-Exchange's knowledge of Sorna's patents" (Compl. ¶¶41, 44, 47, 50). The complaint does not, however, allege specific facts regarding when or how Defendant acquired this knowledge.
VII. Analyst’s Conclusion: Key Questions for the Case
- Evidentiary Development: A threshold question is one of factual proof: given the conclusory nature of the complaint, can the Plaintiff develop an evidentiary record in discovery to show that the accused products practice each and every limitation of at least one asserted claim?
- Claim Scope and Technical Implementation: The case will likely involve a dispute over functional equivalence: does the accused system’s method for delineating patient studies (the "noting the end" step) operate in a way that is covered by the claims, especially in light of the specification's disclosure of a "time out" mechanism?
- Means-Plus-Function Analysis: For the ’214 patent, a core issue will be the interpretation of structure under § 112(f). The outcome will depend on how narrowly the court defines the "corresponding structures" in the specification (e.g., specific software routines and directory structures) and whether the accused products employ identical or equivalent structures to perform the claimed functions.