CR Bard Inc v. Medline Industries LP

1. Case Identification

• Case #: IPR2025-00400
• Patent #: 11,684,347
• Filed: January 3, 2025
• Petitioner(s): C.R. Bard, Inc.
• Patent Owner(s): Medline Industries, LP
• Challenged Claims: 1-8, 10-11, 13-20

2. Patent Overview

• Title: Urinary Catheter Trays
• Brief Description: The ’347 patent is directed to a medical procedure kit comprising a single-layer storage tray for a urinary catheter, syringes, and related medical devices. The tray features multiple compartments to organize components for a catheterization procedure.

3. Grounds for Unpatentability

Ground 1: Obviousness over Solazzo, Serany, Disston, and Imai - Claims 1, 2, 5, 7, 8, 14, 17 are obvious over Solazzo in view of Serany, Disston, and Imai.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), Disston (Patent 3,166,189), and Imai (Japanese Application # 2007-229520).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Solazzo, the primary reference, taught the core limitations of independent claims 1, 14, and 17, including a single-layer medical tray with adjacent first and second compartments separated by a barrier for holding syringes and a medical assembly. For limitations not expressly in Solazzo, Petitioner argued it would be obvious to modify Solazzo by incorporating teachings from the secondary references. Specifically, Serany and Disston taught a closed-system Foley catheter with coiled tubing and a fluid drain bag, and Imai taught grouping multiple syringes in a single compartment.
  • Motivation to Combine: A POSITA would combine the tray of Solazzo with the pre-assembled, closed-system catheter of Serany or Disston to reduce infection risk, a well-known goal in the art. A POSITA would also group syringes in a single compartment, as taught by Imai and suggested by Serany's "logical step-by-step order," to improve organization and facilitate the procedure. The combination was presented as a simple application of known techniques to a known device to achieve predictable results.
  • Expectation of Success: Petitioner asserted a high expectation of success, as the combination involved integrating well-known components for their intended purposes without changing their respective functions.

Ground 2: Obviousness over Solazzo, Serany, Disston, Imai, and Salvadori - Claims 6, 10, 11, 13, 15, 16, 18, 19 are obvious over Solazzo in view of Serany, Disston, Imai, and Salvadori.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), Disston (Patent 3,166,189), Imai (Japanese Application # 2007-229520), and Salvadori (Patent 5,931,303).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon Ground 1, adding Salvadori to teach additional components recited in various dependent claims. Salvadori taught including a "specimen bottle" and "swab sticks" in a catheterization tray. Serany taught including a catheter securement device (safety pin and rubber band), an underbuttocks drape, and a fenestrated drape.
  • Motivation to Combine: A POSITA would be motivated to add these common, ancillary components to the base kit of Ground 1 to create a complete, "all-in-one" catheterization kit. Each component would be added to perform its conventional function, such as allowing for a urine sample collection (Salvadori) or maintaining a sterile field (Serany).

Ground 3: Obviousness over Numata, Serany, and Disston - Claims 1, 2, 5, 7, 8 are obvious over Numata in view of Serany and Disston.

• Prior Art Relied Upon: Numata (Japanese Application # 2006-131284), Serany (Patent 3,329,261), and Disston (Patent 3,166,189).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground presented Numata as an alternative primary reference. Petitioner argued Numata taught a medical procedure kit with a single-layer tray having separate compartments for syringes and a catheter assembly. While Numata's tray was for general medical instruments, Petitioner contended it would have been obvious to adapt it for a Foley catheterization procedure by incorporating the closed-system Foley catheter assembly taught by Serany and Disston.
  • Motivation to Combine: A POSITA would combine the teachings because Numata's packaging system was designed to reduce the risk of nosocomial infections, a primary concern in Foley catheter procedures (i.e., preventing CAUTI). A POSITA would therefore be motivated to use Numata’s superior sterile packaging for the well-known Foley catheter components of Serany and Disston to achieve this shared goal.
  • Expectation of Success: Success would be expected because both Numata and Serany described sterile kits with similar types of components (trays, catheters, syringes, drapes), making their combination straightforward.

• Additional Grounds: Petitioner asserted additional obviousness challenges based on the Numata combination in view of Beddow (for a lubricating jelly application compartment), Salvadori (for a specimen jar), and Imai (for stacking syringes at different heights).

4. Key Claim Construction Positions

• Petitioner argued that the term "a surface defining a single layer tray having a first compartment separated by a barrier from a second compartment" requires that the compartments and the barrier be part of the same, single surface, consistent with a prior Board construction. Petitioner asserted that this limitation would be obvious to a POSITA, who would have understood that such a tray could be manufactured as a single piece using well-known techniques like thermoforming or injection molding. For all other terms, Petitioner proposed their plain and ordinary meaning.

5. Arguments Regarding Discretionary Denial

• §325(d) Factors: Petitioner argued against discretionary denial because the petition presented new prior art and arguments not before the examiner during prosecution. Specifically, the Numata reference (primary reference for Grounds 3-8) was not previously considered. Furthermore, while the Solazzo reference was of record, the examiner did not have the benefit of the Board’s final written decisions on remand in related IPRs, which invalidated substantially similar claims of related patents over Solazzo.
• §314(a) Fintiv Factors: Petitioner argued that the Fintiv factors weigh against discretionary denial. The parallel district court litigation was in its early stages, with no trial date set, no depositions taken, and no claim construction hearing scheduled. Petitioner also stipulated that, if the IPR is instituted, it will not assert the same invalidity grounds in the district court litigation, mitigating concerns of duplicative efforts and inconsistent results.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-8, 10-11, and 13-20 of the ’347 patent as unpatentable.