SandBox Medical LLC v. NeoTech Products LLC

1. Case Identification

• Case #: IPR2019-00246
• Patent #: 6,958,050
• Filed: November 9, 2018
• Petitioner(s): Sandbox Medical, LLC.
• Patent Owner(s): Neotech Products, Inc.
• Challenged Claims: 1-10

2. Patent Overview

• Title: Multi-Purpose Medical Suctioning Device
• Brief Description: The ’050 patent describes a two-piece medical suctioning device, or aspirator. The device includes a first tubular body portion (handle) with a side inlet for manual suction control and a second, detachable tubular portion (catheter) with a soft, flexible tip composed of three distinct sections with different taper angles.

3. Grounds for Unpatentability

Ground 1: Obviousness over Jackson, Kerwin/Behrstock, and Halligan/Penny - Claims 1-6 and 8-10 are obvious over Jackson in view of either Kerwin or Behrstock, and in further view of Halligan or Penny.

• Prior Art Relied Upon: Jackson (Patent 3,595,234), Kerwin (Patent 4,813,926), Behrstock (Patent 4,699,138), Halligan (Patent 3,319,628), and Penny (Patent 3,965,901).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Jackson taught the foundational elements of the invention: a two-piece medical suction device comprising a handle with a side inlet for finger-controlled suction and a detachable catheter. Jackson’s catheter was shown with three sections (primary, secondary, and tertiary). Petitioner contended that remaining limitations were well-known design choices disclosed in the secondary references. For example, Behrstock and Kerwin taught using a soft, flexible material for the catheter tip (claim 1(c)) and transparent or translucent plastic for visualization (claim 1(h)). Kerwin and Behrstock also taught the claimed tapering structure with different taper angles between the catheter sections.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine these references to improve the functionality of the known Jackson aspirator. A POSA would incorporate the soft, flexible, and tapered tip from Kerwin or Behrstock to enhance patient comfort and maneuverability. Similarly, a POSA would use translucent materials as taught by Halligan or Behrstock for the known benefit of visualizing aspirated fluids, which was a standard practice in the medical field. The combination was presented as the predictable application of known features to achieve their established functions.
  • Expectation of Success: A POSA would have a high expectation of success as the combination involved integrating conventional components using standard manufacturing techniques, each performing its known function.

Ground 2: Obviousness over the Combination of Ground 1 and Shedlock - Claim 7 is obvious over the combination of Ground 1 in further view of Shedlock.

• Prior Art Relied Upon: The combination of references from Ground 1, plus Shedlock (Patent 5,114,415).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground specifically addressed claim 7, which adds a "soft pliable flange on said tertiary section near said tip." Petitioner asserted that the base combination of Ground 1 taught all other limitations of claim 1, upon which claim 7 depends. Shedlock was introduced because it explicitly disclosed a suction apparatus with a nozzle having an integral, flexible flange.
  • Motivation to Combine: Petitioner argued a POSA would be motivated to add the flange taught by Shedlock to the aspirator of Ground 1 for its well-known safety function. Flanges were routinely used on suction devices to prevent over-insertion of the catheter into a patient's nostril or throat, thereby preventing injury. Modifying the device from Ground 1 with Shedlock’s safety flange was presented as an obvious improvement.
  • Expectation of Success: Incorporating a simple plastic flange onto the tip of a plastic catheter was a straightforward design modification with a predictable outcome.

Ground 3: Obviousness over Jackson and Common Knowledge - Claims 1-10 are obvious over Jackson in view of the Common Knowledge of a POSA.

• Prior Art Relied Upon: Jackson (Patent 3,595,234) and the common knowledge of a POSA at the time of the invention.

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Jackson disclosed the basic structure of a two-piece aspirator with suction control. All other claimed features—such as using soft, pliable, or translucent plastics, specific taper angles, excluding latex, or adding safety flanges—were not inventive steps but rather implementations of features that were common knowledge in the art of medical device design. For instance, a POSA knew to use soft materials for patient-contacting parts, translucent materials for visualization, and hypoallergenic materials like non-latex plastic to avoid allergic reactions.
  • Motivation to Combine: The motivation was rooted in common sense and standard industry practices. A POSA, starting with the Jackson design, would naturally and predictably implement these well-known features to create a safer, more effective, and commercially viable product. Petitioner framed this as a classic example of unpatentable predictable variation as described in KSR International Co. v. Teleflex Inc.
  • Expectation of Success: A POSA would have a clear expectation of success in applying these general principles of medical device design to the specific aspirator taught by Jackson.

• Additional Grounds: Petitioner asserted an additional obviousness challenge for claim 10 based on the Ground 1 combination in further view of Perla (Patent 5,496,268) to explicitly teach the use of non-vinyl, non-latex materials like polyethylene.

4. Key Claim Construction Positions

• "Device Maximum Diameter": Petitioner proposed this term be construed as the largest straight-line diameter of any circular portion of the device. This construction was argued to be critical because prior art references, such as Kerwin, allegedly disclosed a side inlet proximate to this location, contrary to the Patent Owner’s arguments during prosecution.
• Intended Use Language: Petitioner argued that numerous phrases in the claims (e.g., "to be manually blocked," "for finger control," "to facilitate suctioning usage") constituted non-limiting statements of intended use. Petitioner contended that these functional statements do not impart structural differences over the prior art and should not be given patentable weight in the obviousness analysis.

5. Relief Requested

• Petitioner requests institution of an inter partes review of claims 1-10 of the ’050 patent and cancellation of all challenged claims as unpatentable.