InfoBionic Inc v. CardioNet LLC

1. Case Identification

• Case #: IPR2015-01705
• Patent #: 7,212,850
• Filed: August 10, 2015
• Petitioner(s): InfoBionic, Inc.
• Patent Owner(s): Braemar Manufacturing, LLC
• Challenged Claims: 1-9, 20-21, 31-34, 37-38

2. Patent Overview

• Title: Cardiac Arrhythmia Event Processing and Presentation
• Brief Description: The ’850 patent discloses systems for processing cardiac arrhythmia data, specifically atrial fibrillation (AF) events. The invention involves using both an automated algorithm and a human technician to identify potential AF events, determining a measure of correlation between the two assessments, and selectively presenting a graphical summary if the correlation is sufficient.

3. Grounds for Unpatentability

Ground 1: Claims 1-2, 5-6, 8, 20-21, 31-34, and 37-38 are obvious over Bock in view of Walker and the ACC Guidelines.

• Prior Art Relied Upon: Bock (Patent 6,490,479), Walker (Patent 7,490,085), and ACC Guidelines (Journal of the American College of Cardiology, Sep. 1999).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Bock taught all elements of the independent claims except for the human-assessment component. Bock disclosed a machine-implemented method for identifying AF events from ECG data and pictographically presenting a heart rate trend with an AF burden. Petitioner contended that Bock’s system, which used a primary algorithm to detect AF and a secondary algorithm (a contextual analysis module) to validate the detection before deciding whether to display the results, met the limitations for identifying, obtaining, and pictographically presenting data based on a "measure of correlation." The key distinction was that Bock's assessment was purely algorithmic, not human.
  • Motivation to Combine: Petitioner asserted that a Person of Ordinary Skill in the Art (POSITA) would be motivated to replace Bock’s secondary algorithmic assessment with a human assessment based on the teachings of Walker and the ACC Guidelines. The ACC Guidelines established that it was "critical" for algorithm-detected arrhythmias to be reviewed by an experienced technician to ensure diagnostic accuracy. Walker taught a general framework for enhancing computer-assisted medical diagnoses by incorporating validation and feedback from human experts.
  • Expectation of Success: A POSITA would have a reasonable expectation of success in making this combination. Incorporating human review into an automated diagnostic system was a known technique for improving accuracy, and both references suggested this modification would yield the predictable result of a more reliable diagnostic tool.

Ground 2: Claims 3, 4, and 7 are obvious over Bock, Walker, and the ACC Guidelines in view of Reinhold.

• Prior Art Relied Upon: The combination from Ground 1, plus Reinhold (Patent 4,531,527).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground targeted dependent claims requiring the presentation of heart rate data in "beats-per-minute" (BPM) (claim 3), showing information regarding standard deviation (claim 4), and presenting the heart rate trend and AF burden on different graphs (claim 7). Petitioner argued that Reinhold, which disclosed a remote cardiac monitoring system, taught these conventional data presentation features. Reinhold’s patient reports explicitly plotted heart rate in BPM, showed minimum and maximum heart rates (corresponding to standard deviation), and used separate graphs for different data types to improve clarity.
  • Motivation to Combine: A POSITA would be motivated to incorporate Reinhold’s standard display formats into the primary system of Bock/Walker/ACC to enhance the clinical utility and readability of the output for physicians. These modifications represented the application of known and conventional data visualization techniques to improve a similar device.

Ground 3: Claim 9 is obvious over Bock, Walker, and the ACC Guidelines in view of Chen.

• Prior Art Relied Upon: The combination from Ground 1, plus Chen (Patent 6,470,210).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed claim 9, which added the limitation of "receiving input specifying the defined time period." Chen disclosed an implantable arrhythmia detection system where a physician could use an external programmer to input a specific beginning and ending date/time to define a time span of interest for analysis.
  • Motivation to Combine: A POSITA would combine Chen's user-selectable time period with the primary system to allow clinicians to better evaluate the effects of treatment by analyzing data from specific periods (e.g., before and after therapy). This functionality would be a simple and predictable improvement to make the diagnostic tool more flexible and useful for patient management.

4. Key Claim Construction Positions

• "Measure of Correlation": Petitioner proposed this term be construed as "an amount or degree of relationship between things or variables." This broad construction, supported by plain meaning and the Patent Owner's positions in related litigation, was central to arguing that Bock's algorithmic comparison between its detection and validation modules met this claim limitation.
• "Selectively Presenting": Petitioner proposed this term means "selecting what information is presented, how information is presented, or if information is presented." This construction was intended to be broad enough to encompass Bock's system, which decides if information is presented based on algorithmic validation and how it is presented (e.g., as a graph).
• Means-Plus-Function Terms: Petitioner analyzed several means-plus-function terms (e.g., "monitoring means," "processing means," "display means"). For each, Petitioner identified the corresponding structures disclosed in the ’850 patent (e.g., processing system 106, monitoring station 105) and argued that the prior art, particularly Bock’s modular system architecture, disclosed the same or equivalent structures performing the claimed functions.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that institution should not be denied under 35 U.S.C. §325(d). Although a reference sharing the same specification as Bock was considered during the original prosecution, Petitioner contended that the asserted combination with Walker and the ACC Guidelines was never before the Examiner. Since these new references taught the very feature (human assessment) that was added to overcome the Examiner's prior rejections, the grounds presented in the petition were argued to be substantially new and not cumulative to what was previously considered.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-9, 20-21, 31-34, and 37-38 of Patent 7,212,850 as unpatentable under 35 U.S.C. §103.