DCT

6:14-cv-00628

Uniloc USA Inc v. Greenway Medical Tech Inc

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 6:14-cv-00628, E.D. Tex., 07/18/2014
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant is deemed to reside in the district, has committed alleged acts of infringement in the district, has transacted business involving the accused products in the district, and/or has regular and established places of business in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s electronic health record software infringes two patents related to methods for flexibly organizing, displaying, and processing medical data.
  • Technical Context: The technology at issue involves customizable electronic health record (EHR) systems that allow for user-defined data structures and rule-based processing of patient information.
  • Key Procedural History: The complaint is an original filing and does not mention any prior litigation, inter partes review proceedings, or licensing history between the parties.

Case Timeline

Date Event
1995-07-20 ’526 Patent and ’451 Patent Priority Date
1997-10-28 U.S. Patent No. 5,682,526 Issued
1998-02-03 U.S. Patent No. 5,715,451 Issued
2014-07-18 Complaint Filing Date

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

U.S. Patent No. 5,682,526, “METHOD AND SYSTEM FOR FLEXIBLY ORGANIZING, RECORDING, AND DISPLAYING MEDICAL PATIENT CARE INFORMATION USING FIELDS IN A FLOWSHEET,” issued Oct. 28, 1997

The Invention Explained

  • Problem Addressed: The patent describes the shortcomings of prior art methods for maintaining patient information. It notes that physical charts are inefficient and that existing electronic systems are often too rigid, preventing healthcare providers from adapting the system's parameter organization to their specific needs (ʼ526 Patent, col. 1:40-58).
  • The Patented Solution: The invention provides a system that allows users to customize a "patient information hierarchy" to define how data is organized and to create "flowsheets" for data entry and viewing. A central feature is the ability to link parameters, such that entering a specific value for one parameter (a "linked-from" parameter) automatically causes associated "linked-to" parameters to be displayed for data entry, thereby streamlining clinical workflows (ʼ526 Patent, col. 2:17-21; FIG. 4).
  • Technical Importance: This approach provided a method for healthcare organizations to create more adaptable and efficient electronic charting systems tailored to their particular procedures, rather than being limited by a one-size-fits-all software design.

Key Claims at a Glance

  • The complaint asserts at least independent Claim 1 (Compl. ¶12).
  • Claim 1 recites a method for designing a patient information hierarchy, comprising the key steps of:
    • Receiving instructions from a user to create and define a new parameter with possible result values.
    • Receiving an instruction to link a "linked-from possible result value" of that new parameter to one or more other "linked-to parameters."
    • Linking the parameters within the hierarchy such that when the new parameter is displayed and has the "linked-from possible result value," the "linked-to parameters are displayed in conjunction with the new parameter."

U.S. Patent No. 5,715,451, “METHOD AND SYSTEM FOR CONSTRUCTING FORMULAE FOR PROCESSING MEDICAL DATA,” issued Feb. 3, 1998

The Invention Explained

  • Problem Addressed: The patent explains that making patient care decisions often requires professionals to review large quantities of raw data. It identifies a need for a customizable means to manipulate this raw information to produce "higher-level patient information" that provides a more useful basis for clinical decisions (ʼ451 Patent, col. 1:29-39).
  • The Patented Solution: The invention provides a "formula construction facility" that allows a user to build a formula for a time-indexed output parameter based on time-indexed input parameters (ʼ451 Patent, col. 2:32-36). The user can select input data, specify a relevant time interval, and apply functions (e.g., maximum, minimum, average) and operators to reduce multiple data points into a single, conclusive value or statement (ʼ451 Patent, Abstract; FIG. 4).
  • Technical Importance: The invention provided a framework for implementing user-defined clinical decision support rules, custom alerts, and calculated parameters directly within an electronic medical records system.

Key Claims at a Glance

  • The complaint asserts at least independent Claim 6 (Compl. ¶22).
  • Claim 6 recites a method for constructing a formula to derive a "medical conclusion" from time-indexed medical data, comprising the key steps of:
    • Receiving user input via a window-based interface identifying a time-indexed medical data input.
    • Receiving user input identifying a time interval to qualify the data.
    • Receiving user input identifying a selection function (e.g., first, last, max) to select one event from the qualified data.
    • Receiving user input identifying a data component to be extracted from the selected event.
    • Storing a formula that applies the function to extract the data component, such that the formula can be used to derive and display a "medical conclusion."

III. The Accused Instrumentality

  • Product Identification: Greenway Medical PrimeSUITE (Compl. ¶12, ¶22).
  • Functionality and Market Context: The complaint identifies PrimeSUITE as an electronic health record software product. The complaint does not provide specific details about the technical operation of PrimeSUITE's data organization, display, or processing features. It makes general allegations that the product's operation "practice[s] the method of one or more claims" of the patents-in-suit (Compl. ¶12, ¶22).
  • No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain claim charts or detailed infringement contentions. The analysis below is based on the general allegations made against the accused product category.

’526 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method...for designing, under the control of a user, a patient information hierarchy...containing a plurality of parameters including a linked-from parameter...linked to one or more linked-to parameters... The PrimeSUITE system is alleged to provide tools for users to design and customize the structure of patient data, including establishing relationships between different data parameters. ¶12 col. 12:40-44
(c) receiving an instruction from the user to specify a plurality of indicated possible result values for the new parameter; The PrimeSUITE system is alleged to allow users to define a set of possible values for a given data field (e.g., a drop-down list). ¶12 col. 12:51-54
(e) receiving an instruction from the user to link an indicated linked-from possible result value...to one or more indicated linked-to parameters... The PrimeSUITE system is alleged to allow a user to create a rule where selecting a specific value for one parameter creates a link to other parameters. ¶12 col. 12:58-64
(f) ...linking the indicated linked-from possible result value to the indicated linked-to parameters, such that...if the new parameter has the linked-from possible result value, the linked-to parameters are displayed in conjunction with the new parameter. The PrimeSUITE system is alleged to execute the user-defined link, such that when a user enters the specified value for the first parameter, the system automatically displays the linked secondary parameters for viewing or data entry. ¶12 col. 12:65-col. 13:2

’451 Patent Infringement Allegations

Claim Element (from Independent Claim 6) Alleged Infringing Functionality Complaint Citation Patent Citation
A method...using a window-based user interface, a formula for deriving a medical conclusion from...time-indexed medical data inputs... The PrimeSUITE system is alleged to provide a graphical user interface for creating formulas or rules that process patient data recorded over time to generate a "medical conclusion." ¶22 col. 16:6-12
receiving input via the window-based user interface identifying a time interval qualifying the events of the identified time-indexed medical data input; The PrimeSUITE system is alleged to allow a user building a formula to specify a time frame for the input data (e.g., "last 24 hours," "since admission"). ¶22 col. 16:16-19
receiving...an instruction identifying a selection function for selecting one event from the events...qualified by the identified time interval; The PrimeSUITE system is alleged to provide functions within its formula builder (e.g., FIRST, LAST, MAX, MIN) that a user can select to isolate a single data point from a set of data points within the specified time interval. ¶22 col. 16:20-24
storing a formula for applying the identified selection function to events...in order to select one of the events, and for extracting the identified data component of the selected event... The PrimeSUITE system is alleged to save the user-defined rule, which incorporates the selected function and data component, so that it can be executed to produce an output. ¶22 col. 16:29-35
  • Identified Points of Contention:
    • Evidentiary Questions: As the complaint provides no specific evidence of the PrimeSUITE system's functionality, a central issue will be whether discovery reveals that the accused product in fact performs the specific steps of the asserted method claims. The analysis will depend entirely on evidence of the product's actual operation.
    • Scope Questions: A potential dispute for the ’526 Patent may concern the meaning of "displayed in conjunction with." For the ’451 Patent, a key dispute may arise over the definition of a "medical conclusion" and whether the accused product's output meets that definition.

V. Key Claim Terms for Construction

  • Term: "linked-to parameters are displayed in conjunction with the new parameter" (’526 Patent, Claim 1)

    • Context and Importance: This term is critical as it defines the functional outcome of the claimed linking method. The case may turn on whether the accused system's display of related data fields meets the "in conjunction with" requirement.
    • Intrinsic Evidence for a Broader Interpretation: The term itself is not explicitly defined, which may support an interpretation that covers any display of the linked parameters that is part of the same, continuous user workflow, not necessarily on the same screen at the same time.
    • Intrinsic Evidence for a Narrower Interpretation: The patent’s figures and description of the preferred embodiment show the linked parameters appearing nested directly below the "linked-from" parameter in a single flowsheet view (e.g., ’526 Patent, FIG. 13; col. 10:20-31), which may support a narrower construction requiring a close visual and structural relationship.
  • Term: "medical conclusion" (’451 Patent, Claim 6)

    • Context and Importance: This term defines the required output of the claimed formula. Its construction will determine whether a simple calculated numerical value infringes, or if a more complex, text-based assessment is required.
    • Intrinsic Evidence for a Broader Interpretation: The patent’s summary notes the invention is for producing "higher-level patient information," which could be argued to include derived numerical values (e.g., an average blood pressure) (’451 Patent, col. 1:47-49).
    • Intrinsic Evidence for a Narrower Interpretation: The patent repeatedly refers to generating "preliminary medical judgments and treatment recommendations" (’451 Patent, col. 2:51-52). A detailed embodiment shows a formula that outputs a complex textual diagnosis: "Patient exhibits apparent Sinus Bradycardia..." (’451 Patent, FIG. 11), suggesting "medical conclusion" may require a qualitative or diagnostic assessment, not just a quantitative one.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe both patents. The factual basis asserted is Defendant’s provision of "instruction manuals on the operation of the infringing products" and its "sales and support activities," which allegedly encourage customers to use the PrimeSUITE system in an infringing manner (Compl. ¶14, ¶24).
  • Willful Infringement: The complaint alleges that Defendant "specifically intended" to cause infringement or, alternatively, was "willfully blind to the possibility," but does not plead specific facts demonstrating pre-suit knowledge of the patents (Compl. ¶14, ¶24).

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

  • A primary issue will be one of evidentiary proof: Given the complaint’s high-level allegations, what specific evidence will discovery produce to show that the Greenway PrimeSUITE software actually performs the user-driven, multi-step methods of dynamically linking data parameters (’526 patent) and constructing time-based clinical formulas (’451 patent)?
  • The case may also turn on a key question of claim scope: Can the term "medical conclusion" in the ’451 patent be construed to cover any calculated numerical output generated by the accused software, or will the patent’s detailed examples of text-based diagnostic statements limit the term to a more sophisticated, qualitative assessment?