SHDS Inc v. TruInject Corp

1. Case Identification

• Case #: IPR2020-00935
• Patent #: 10,290,231
• Filed: May 13, 2020
• Petitioner(s): SHDS, Inc. and Galderma Laboratories, L.P.
• Patent Owner(s): TruInject Corp.
• Challenged Claims: 1, 3, 4, 6, 10-12, 15-19, and 21-24

2. Patent Overview

• Title: Automated Detection of Performance Characteristics in an Injection Training System
• Brief Description: The ’231 patent describes systems and methods for medical injection training. The technology uses sensor-based measurements of a syringe's position, orientation, and use characteristics, which are processed and combined with a digital three-dimensional model of an anatomical training apparatus to provide a real-time graphical depiction of the training injection.

3. Grounds for Unpatentability

Ground 1: Obviousness over Samosky, Mukherjee 2014, and Mukherjee 2012 - Claims 1, 3, 4, 6, 10, 11, 15, 17, 18, and 21-24

• Prior Art Relied Upon: Samosky (Application # 2013/0323700), Mukherjee 2014 (an IEEE journal publication), and Mukherjee 2012 (an IEEE conference publication).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued Samosky taught a comprehensive hybrid physical-virtual training system for clinical procedures, including an anatomically-shaped model, instrument tracking (e.g., a syringe), signal processors, and a 3D graphical display for providing feedback and performance metrics (e.g., needle trajectory, injection volume). However, the Examiner allowed the ’231 patent claims based on the limitation of displaying a "dynamic position of the plunger in real time." Petitioner contended that Mukherjee 2014 and Mukherjee 2012 remedied this perceived deficiency. Both Mukherjee references disclosed a training syringe with an integrated Hall Effect sensor to precisely measure and display plunger position and injection rate in real-time, providing a more realistic training experience than Samosky's separate flow meter. The combination of Samosky's system with Mukherjee's sensor-equipped syringe allegedly rendered all limitations of the independent claims obvious.
  • Motivation to Combine: A POSITA would combine the teachings because all three references address the same problem of providing effective, simulated injection training. A POSITA would replace Samosky’s external flow meter with Mukherjee’s integrated sensor-syringe to improve the system's realism and accuracy in determining plunger position and flow rate. This modification would be a predictable improvement to Samosky's existing framework for tracking and displaying performance metrics.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success in incorporating Mukherjee’s sensor into a syringe for use in Samosky's system, as it involved applying a known sensor technology to a known training system to achieve the predictable result of real-time plunger position display.

Ground 2: Obviousness over Samosky, Mukherjee 2014, Mukherjee 2012, and Toly - Claim 12

• Prior Art Relied Upon: Samosky (Application # 2013/0323700), Mukherjee 2014, Mukherjee 2012, and Toly (Application # 2005/0181342).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground specifically targeted dependent claim 12, which added limitations requiring the system to describe the training session with information such as training date/time, trainee identity, score, and a pass/fail determination. Petitioner asserted that the primary combination of Samosky and Mukherjee taught most of these elements, as Samosky disclosed tracking trainee identity, session duration, and performance scores. To the extent the primary combination did not explicitly teach a "pass/fail determination," Petitioner argued Toly supplied this element by disclosing a training system for needle insertion that results in a "pass or fail grade."
  • Motivation to Combine: A POSITA would combine Toly's pass/fail metric with the Samosky system to provide a clear, summative assessment of trainee performance. Adding such a common and useful training metric would have been an obvious and simple modification to enhance the feedback capabilities of Samosky's system.
  • Expectation of Success: Success was expected as it merely involved adding a known type of training assessment metric (pass/fail) to an existing data collection and analysis framework.

Ground 3: Obviousness over Samosky, Mukherjee 2014, Mukherjee 2012, and Lampotang, as evidenced by Sinclair - Claims 16 and 19

• Prior Art Relied Upon: Samosky (Application # 2013/0323700), Mukherjee 2014, Mukherjee 2012, Lampotang (Application # 2012/0280988), and Sinclair (Patent 5,766,016).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed claims 16 and 19, which required "altering the view of the training injection... by rotating the view." While the primary combination taught a 3D graphical display, Petitioner introduced Lampotang and Sinclair to explicitly teach the rotation of this view. Lampotang disclosed a "3D perspective controller" for a handheld device to control the "camera" perspective of a 3D image, including any desired perspective obtained by rotation. Sinclair further evidenced this concept by describing a surgical simulator that could replay a procedure, providing valuable information on instrument location from various viewpoints.
  • Motivation to Combine: A POSITA would have been motivated to add the view-rotation functionality of Lampotang and Sinclair to the Samosky system. For any system that provides 3D visualization, allowing a user to rotate the view is a fundamental and obvious improvement that enables a more thorough analysis of the simulated event from different angles.
  • Expectation of Success: This modification was a routine and predictable enhancement for 3D graphical interfaces, and a POSITA would have readily known how to implement such a feature.

4. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under §325(d) and §314(a).
• Under §325(d), Petitioner asserted this was the first IPR filed against the ’231 patent. It argued that the Mukherjee 2014 and Mukherjee 2012 references, which were central to the petition's key arguments, were not considered during prosecution and were not cumulative to the art of record.
• Under §314(a) (and related General Plastic factors), Petitioner contended that denial was inappropriate because this was not a follow-on petition, the claims of the ’231 patent were completely different from those of a related patent (’836 patent) for which an IPR was previously denied, and the asserted prior art was different.

5. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1, 3, 4, 6, 10-12, 15-19, and 21-24 of the ’231 patent as unpatentable under 35 U.S.C. §103.