InfoBionic Inc v. Braemar Mfg LLC

1. Case Identification

• Case #: IPR2016-01236
• Patent #: 7,907,996
• Filed: June 22, 2016
• Petitioner(s): InfoBionic, Inc.
• Patent Owner(s): Braemar Manufacturing, LLC
• Challenged Claims: 1-28

2. Patent Overview

• Title: System and Method for Processing and Presenting Arrhythmia Information to Facilitate Heart Arrhythmia Identification and Treatment
• Brief Description: The ’996 patent describes systems and methods for monitoring patients for atrial fibrillation (AF). The technology focuses on processing physiological data to identify AF events, receiving a human assessment to validate a subset of those events, and then pictographically presenting the validated AF event data alongside heart rate trend data on a common time scale.

3. Grounds for Unpatentability

Ground 1: Obviousness over Baker, Xu, and Hatke - Claims 1-28 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 prior art combination taught every limitation of the challenged claims. Independent claims 1, 12, 18, and 23 generally require: (1) identifying AF events in physiological data over multiple time intervals; (2) obtaining heart rate data; (3) receiving a human assessment of a subset of the identified AF events; and (4) pictographically presenting the heart rate trend and AF events on a common time scale based on the human assessment.
    • Baker was argued to teach a system for long-term AF monitoring that obtains physiological data, uses an algorithm to identify AF events, and sends the data to a central monitoring system. At the central system, a technician validates the detected events (a human assessment) before sending a graphical report to a physician. Petitioner contended Baker taught the overall framework but lacked specific details on the algorithm and the graphical layout.
    • Xu was presented to supply the algorithm details missing from Baker. Xu described known AF detection algorithms, including those analyzing R-R intervals and QRS morphology, and taught a method of calibrating a detector by comparing its output to human assessments. Crucially, Xu taught that once a detector's performance is validated against human review to a certain threshold (e.g., 97% accuracy), it is "ready to use" without further human assessment. Petitioner asserted this directly taught receiving a human assessment on only a subset of the total events (i.e., during the initial validation phase).
    • Hatke was argued to provide the missing teachings on data presentation. Hatke, directed to monitoring sleep apnea, disclosed displaying physiological trend data (oxygen saturation) alongside event data (apnea events) on a single graph with a common time scale. Petitioner argued Hatke’s graphical layout was strikingly similar to Figure 2 of the ’996 patent and that a person of ordinary skill in the art (POSITA) would have found it obvious to apply this standard graphical technique to display AF event data and heart rate data, as taught by the combination of Baker and Xu. Hatke also taught displaying a range and average of the physiological data for each time interval.
  • Motivation to Combine: Petitioner argued a POSITA would combine these references to create an improved AF monitoring system. Baker expressly invited the use of "well known" algorithms, and Xu provided a suitable, efficient, and accurate algorithm. The motivation to combine Baker and Xu was to improve patient care and reduce physician time wasted on false alarms by using a system that is validated for accuracy. A POSITA would then incorporate Hatke's intuitive display techniques because physicians needed to evaluate heart rate trends alongside the timeline of AF events for effective diagnosis and treatment. Graphing related data sets on a common time scale was a time-tested design practice to efficiently convey a patient's condition.
  • Expectation of Success: Petitioner contended a POSITA would have had a high expectation of success. The combination involved applying a known algorithm (Xu) to a known monitoring framework (Baker) and using a conventional, well-established graphical display method (Hatke) to visualize the resulting data. These were all compatible technologies with predictable results.

4. Key Claim Construction Positions

• Petitioner argued that several terms in the independent and dependent claims, particularly in apparatus claim 18, were means-plus-function limitations under 35 U.S.C. § 112, ¶ 6. These constructions were central to mapping the prior art.
• "Means for identifying AF events" (claim 18): Petitioner proposed that the corresponding structure disclosed in the ’996 patent was an algorithm implementing either an "RR variability" or "QRS morphology" technique, and their equivalents. This construction was critical because Petitioner then argued that both Baker (via incorporated reference) and Xu explicitly taught using these exact techniques for AF detection.
• "Means for pictographically presenting information" (claim 18): Petitioner identified the corresponding structure as a "computer screen or printer, and their equivalents." This broad construction allowed Petitioner to argue that the standard computer systems with displays disclosed in Baker, Xu, and Hatke met this limitation.
• "Means for determining that the identified AF events are valid" (claim 19): Petitioner argued the structure was an algorithm that determines if the percentage of automatically-identified events matching human-assessed events exceeds a threshold. This mapped directly to Xu's teaching of validating a detector's accuracy against a performance threshold (e.g., 97%).

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise its discretion to deny institution under 35 U.S.C. § 325(d), despite a prior petition on the same patent having been denied (IPR2015-01704).
• The core argument was that this petition was not the "same or substantially the same" as the prior one. Petitioner asserted this petition was based on an entirely different set of prior art references (Baker, Xu, and Hatke were all new) and new arguments. The prior petition relied on a different primary reference, and Petitioner argued the new combination presented different technical teachings that the Patent Office had not previously considered. Furthermore, this petition challenged all 28 claims, including 24 dependent claims not challenged previously.

6. Relief Requested

• Petitioner requested that the Board institute an inter partes review and cancel claims 1-28 of the ’996 patent as unpatentable.