InfoBionic Inc v. Braemar Mfg LLC

1. Case Identification

• Case #: IPR2016-01237
• Patent #: 7,212,850
• Filed: June 22, 2016
• Petitioner(s): InfoBionic, Inc.
• Patent Owner(s): Braemar Manufacturing, LLC
• Challenged Claims: 1-44

2. Patent Overview

• Title: System and Method for Processing and Presenting Arrhythmia Information to Facilitate Heart Arrhythmia Identification and Treatment
• Brief Description: The ’850 patent relates to systems and methods for processing and presenting cardiac arrhythmia information. The technology involves automatically identifying atrial fibrillation (AF) events from physiological data, determining a measure of correlation between the automatically identified events and human assessments, and then pictographically presenting heart rate trend data with AF event "burden" on a common time scale if the correlation indicates the automatic detection is valid.

3. Grounds for Unpatentability

Ground 1: Obviousness over Baker, Xu, and Hatke - Claims 1-44 are obvious over Baker in view of Xu and Hatke.

• Prior Art Relied Upon: Baker (Application # 2002/0147409), Xu (Application # 2003/0216654), and Hatke (Patent 5,206,807).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the combination of Baker, Xu, and Hatke taught all limitations of the challenged claims. Baker disclosed the foundational system: monitoring a patient for AF events, sending data to a central station where a technician validates the detected events, and reporting the validated events to a physician. However, Baker did not specify the algorithm for AF detection or the graphical layout for the report, instead suggesting the use of algorithms "well known" in the art. Petitioner asserted that Xu supplied the missing algorithm. Xu taught an efficient and accurate AF detection algorithm using RR intervals and QRS morphology and disclosed a method for calibrating the algorithm by comparing its output to human assessments to verify its accuracy before clinical use. Finally, Petitioner argued that Hatke supplied the missing graphical layout. Hatke taught displaying two related sets of physiological data—trend data (oxygen saturation) and event data (sleep apnea)—on a common time scale in a manner Petitioner described as strikingly similar to the figures in the ’850 patent. The combination, therefore, disclosed obtaining heart rate data (Baker, Xu), automatically identifying AF events (Baker's system using Xu's algorithm), receiving human assessments to validate the detector's accuracy (Baker's technician review combined with Xu's calibration method), and pictographically presenting the validated data in a clinically useful format (Baker's reporting function implemented with Hatke's graphical display technique).
  • Motivation to Combine: A POSITA would combine these references to create an improved cardiac monitoring system. Baker expressly invited the use of a known algorithm for AF detection, and Xu provided a highly desirable, accurate, and efficient algorithm, making its integration obvious. The motivation to add Hatke's teachings stemmed from the well-established need to present complex medical data clearly and intuitively. A POSITA would have recognized that applying Hatke's proven method for graphically correlating trend and event data to the AF data from the Baker/Xu system would allow a physician to more quickly and effectively assess a patient's condition, which was a known goal in the field.
  • Expectation of Success: A POSITA would have had a high expectation of success in making this combination. The integration involved applying a known graphical display technique (Hatke) to a known type of medical data (heart rate and AF events from Baker/Xu) and implementing a known type of algorithm (Xu) within a conventional monitoring framework (Baker). Each component was being used for its intended and well-understood purpose, presenting no significant technical hurdles.

4. Key Claim Construction Positions

Petitioner proposed constructions for several means-plus-function terms that were central to its obviousness arguments.

• "Means for identifying AF events" (claims 33, 37-40): Petitioner argued that the corresponding structure in the specification was a processor implementing "RR variability and QRS morphology" techniques. This construction was critical because Xu explicitly taught using these same well-known techniques for AF detection, allowing for a direct mapping of the prior art onto the claimed function's required structure.
• "Means for determining at least one measure of correlation" (claim 39): Petitioner contended that the specification disclosed the concept of comparing machine-detected events to human-assessed events against a threshold (e.g., >50% match) to validate the data. The corresponding structure was therefore an algorithm that determines the percentage of matching events. This was important as Xu taught a specific method for this function: calculating sensitivity, accuracy, and specificity and comparing them to a high threshold (e.g., 97%) to confirm detector performance.
• "Means for pictographically presenting" (claims 33, 34, 37): Petitioner argued this term's structure should be construed as a general-purpose computer with a screen or printer, which does not require special programming to generate graphs. This broad construction was intended to ensure that prior art like Hatke, which illustrates conventional graphical displays of medical data, would read on the claims.

5. Arguments Regarding Discretionary Denial

Petitioner presented arguments as to why the Board should not exercise its discretion under 35 U.S.C. §325(d) to deny institution based on a previously filed petition (IPR2015-01705). Petitioner argued that the instant petition presented new and different arguments based on an "entirely different set of prior art references." The petition asserted that the primary reference, Baker, and the key graphical reference, Hatke, were not previously before the Office in connection with the ’850 patent. Furthermore, this petition challenged all 44 claims, including nine independent and twenty-seven dependent claims not challenged in the prior proceeding.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of all claims 1-44 of the ’850 patent as unpatentable.