SHDS Inc v. TruInject Corp

1. Case Identification

• Case #: IPR2020-00042
• Patent #: 9,792,836
• Filed: October 11, 2019
• Petitioner(s): SHDS, Inc. and Galderma Laboratories, L.P.
• Patent Owner(s): Truinject Corp.
• Challenged Claims: 1-22

2. Patent Overview

• Title: Injection Training Apparatus Using 3D Position Sensor
• Brief Description: The ’836 patent discloses an anatomically shaped injection training apparatus. The device includes a hollow base, a clear elastomer layer, and an opaque outer layer, which together form an anatomical shape, and a 3D tracking system positioned inside the base to determine the location of a needle inserted into the layers.

3. Grounds for Unpatentability

Ground 1: Obviousness over Goldstein and Lacey - Claims 1, 3-6, 9-11, and 16-20 are obvious over Goldstein in view of Lacey.

• Prior Art Relied Upon: Goldstein (Patent 6,485,308) and Lacey (Application # 2005/0084833).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Goldstein taught a needle biopsy training aid (a breast model) comprising most elements of the independent claims, including an at least partially hollow base (stand), a clear elastomer layer (simulated adipose tissue), and an opaque outer layer (simulated skin) that form an anatomical shape. While Goldstein included a single camera, it did not explicitly disclose a "3D tracking system." Petitioner asserted that Lacey supplied this missing element by teaching a surgical training simulator that used multiple cameras within a body form to function as a 3D tracking system, generating 3D position data for medical instruments using stereo triangulation. The combination of Goldstein’s physical model and Lacey’s tracking system allegedly rendered the apparatus and manufacturing method claims obvious.
  • Motivation to Combine: A POSITA would combine Lacey's 3D tracking system with Goldstein's training apparatus to more accurately track the three-dimensional position of the needle. This modification would provide a more realistic and effective simulation for training purposes, a well-understood goal in the art.
  • Expectation of Success: Because 3D tracking systems like Lacey's were well known, a POSITA would have had a reasonable expectation of success in integrating such a system into Goldstein's physical model.

Ground 2: Obviousness over Goldstein, Lacey, and Wierinck - Claims 2, 7-8, and 21 are obvious over Goldstein and Lacey in view of Wierinck.

• Prior Art Relied Upon: Goldstein (Patent 6,485,308), Lacey (Application # 2005/0084833), and Wierinck (a 2007 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed claims requiring that "light is emitted from the needle" (an active marker). Petitioner contended that the primary combination of Goldstein and Lacey relied on passive tracking (detecting light reflected from an instrument). Wierinck was introduced because it taught a dental training simulator that employed an optical tracking device with an active marker—a light emitter (LED) attached to the dental tool—to track its 3D position.
  • Motivation to Combine: A POSITA would combine Wierinck's teaching of active markers with the Goldstein/Lacey system because using active markers was a known and obvious alternative to passive markers for optical tracking systems. This would have been a simple design choice to achieve the same goal of 3D position tracking.

Ground 3: Obviousness over Goldstein, Lacey, and Lampotang - Claims 12-15 are obvious over Goldstein and Lacey in view of Lampotang.

• Prior Art Relied Upon: Goldstein (Patent 6,485,308), Lacey (Application # 2005/0084833), and Lampotang (Application # 2012/0280988).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground targeted dependent claims requiring an "animated depiction of the needle passing through the injection site." Petitioner argued that Lampotang taught an interactive training system that tracked a physical syringe and mannequin, and instantiated an "animated depiction" of the needle moving through a virtual model of internal anatomy on a display in response to user actions.
  • Motivation to Combine: A POSITA would incorporate Lampotang's animated display into the Goldstein/Lacey training system to provide superior visual feedback to the trainee. This enhancement would be particularly beneficial for simulating "blind" procedures where direct sight is obscured, a key feature of Goldstein's model.

Ground 4: Obviousness over Goldstein, Lacey, and Placik - Claim 22 is obvious over Goldstein and Lacey in view of Placik.

• Prior Art Relied Upon: Goldstein (Patent 6,485,308), Lacey (Application # 2005/0084833), and Placik (Patent 9,017,080).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed claim 22, a method claim which depended from claim 18 and required that the "anatomical shape comprises a human skull shape." While Goldstein taught a breast model, Placik taught a facial injection trainer with an inner base specifically "shaped as part of the human skull."
  • Motivation to Combine: A POSITA would have been motivated to use a skull-shaped base like Placik’s in the Goldstein/Lacey system to create a training model for a different anatomical region (the head/face). This represented a simple and predictable adaptation of the base technology for a different, but common, injection training application.

4. Key Claim Construction Positions

• "3D Tracking System": Petitioner proposed this term should be construed to mean one or more sensors—such as a camera, a stereoscopic pair of cameras, or an array of light sensors—positioned inside the base and capable of detecting the location of an object in three dimensions. This construction was central to mapping the camera-based systems of the prior art onto the claims.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) was unwarranted. It was asserted that this was the first IPR filed against the ’836 patent. While Goldstein, Lacey, Lampotang, and Placik were cited in an Information Disclosure Statement during prosecution, Petitioner contended that none of these references were substantively relied upon by the examiner to reject the issued claims. Furthermore, the Wierinck reference was never considered during prosecution. Therefore, the petition raised new arguments based on combinations not previously evaluated by the Office.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-22 of the ’836 patent as unpatentable under 35 U.S.C. §103.