PTAB

IPR2020-00937

SHDS Inc v. TruInject Corp

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Automated Detection of Performance Characteristics in an Injection Training System
  • Brief Description: The ’232 patent describes an injection training system for facial injection techniques. The system comprises a syringe, an anatomical model of a human head for practice, a location sensing system to track the syringe’s position and orientation, and a processing unit that provides 3D graphical feedback on a display.

3. Grounds for Unpatentability

Ground 1: Claims 1, 3, 6-13, 15, 16, 20-21, and 24-26 are obvious over Lampotang, Mukherjee 2014, and Mukherjee 2012.

  • Prior Art Relied Upon: Lampotang (Application # 2012/0280988), Mukherjee 2014 (an IEEE journal article), and Mukherjee 2012 (an IEEE conference paper).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lampotang taught the foundational elements of the challenged claims, including an interactive mixed-reality training system with a physical mannequin, a tracked syringe, and a virtual 3D model of internal anatomy displayed to the user. Lampotang disclosed using an electromagnetic tracking system to determine the syringe needle's position and orientation relative to the mannequin. However, the ’232 patent was allowed over prior art of record for its inclusion of a "dynamic position of the plunger in real-time." Petitioner contended that Mukherjee 2014 and Mukherjee 2012, which were not before the examiner, explicitly teach this missing element. Both Mukherjee references describe a training syringe modified with a Hall Effect sensor specifically to measure and display the dynamic position and rate of injection of the plunger in real-time on a graphical user interface.
    • Motivation to Combine: A POSITA would combine the teachings because the references address the same problem of providing a comprehensive, simulated injection training system. A POSITA would have been motivated to integrate Mukherjee’s real-time plunger tracking into Lampotang’s 3D visualization system to provide more complete feedback to the trainee, showing not only where the needle is but also how the injection is being administered. This combination would predictably enhance the effectiveness of the training.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining these systems. The integration involved adding a known sensor technology for plunger tracking (Mukherjee) to a known augmented reality visualization system (Lampotang), which was a straightforward application of existing technologies to achieve the predictable result of an improved training simulator.

Ground 2: Claims 4, 22, and 23 are obvious over Lampotang, Mukherjee 2012, Mukherjee 2014, and Dawson.

  • Prior Art Relied Upon: Lampotang (Application # 2012/0280988), Mukherjee 2012, Mukherjee 2014, and Dawson (Application # 2004/0234933).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on the combination of Lampotang and Mukherjee from Ground 1. Petitioner asserted that claim 4’s limitation—displaying a graphical depiction in "replay after the training injection is completed"—is taught by Dawson. Dawson discloses saving sensor orientation and position data during a training session and using that data to "drive a virtual 3D scene to permit the user to see his or her actions played back."
    • Motivation to Combine: The motivation to add Dawson’s teachings is based on the well-known benefit of post-performance review in training. A POSITA would combine Dawson’s replay functionality with the advanced real-time system of Lampotang and Mukherjee to allow for post-session analysis and critique by both the user and a supervisor. This would be a simple and obvious improvement to enhance the training system's pedagogical value.

Ground 3: Claim 14 is obvious over Lampotang, Mukherjee 2012, Mukherjee 2014, and Samosky.

  • Prior Art Relied Upon: Lampotang (Application # 2012/0280988), Mukherjee 2012, Mukherjee 2014, and Samosky (Application # 2013/0323700).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground also builds on the primary combination from Ground 1. Petitioner argued that the limitation of dependent claim 14, which requires the graphical depiction to comprise an "injection target indicator," is taught by Samosky. Samosky discloses using visual cues in a training simulation, such as a "bull's-eye" visualization, to show a needle tip approaching a target nerve and to indicate when a goal is reached.
    • Motivation to Combine: A POSITA would be motivated to add a target indicator to the system of Lampotang and Mukherjee to improve usability. While Lampotang teaches navigating a tool to a "correct location," adding an explicit visual indicator as taught by Samosky would make it easier for a trainee to identify the target and assess their accuracy. This represents a known design choice for improving graphical user interfaces in training applications.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under both 35 U.S.C. §325(d) and §314(a).
  • Regarding §325(d), Petitioner asserted that the primary references for the key claim limitation—Mukherjee 2014 and Mukherjee 2012—were not considered during prosecution and are not cumulative. These references teach the "dynamic position of the plunger in real-time" limitation that was the basis for allowance, making them highly material.
  • Regarding §314(a), Petitioner contended this IPR is not a "follow-on" petition to a previously denied IPR on the related ’836 patent. It was argued that the challenged claims of the ’232 patent are completely different, were allowed on different grounds, and are challenged here with different prior art teaching the distinct limitations.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1, 3-4, 6-16, and 20-26 of the ’232 patent as unpatentable.