CR Bard Inc v. Medline Industries LP

1. Case Identification

• Case #: IPR2025-00401
• Patent #: 11,661,219
• Filed: January 3, 2025
• Petitioner(s): C.R. Bard, Inc.
• Patent Owner(s): Medline Industries, LP
• Challenged Claims: 1-7, 9-16

2. Patent Overview

• Title: Storage Container for a Catheter and Related Medical Devices
• Brief Description: The ’219 patent is directed to a medical procedure kit comprising a single-layer tray with multiple compartments for organizing components used in a catheterization procedure, such as a Foley catheter, syringes, and lubricating jelly.

3. Grounds for Unpatentability

Ground 1: Obviousness over Numata Combination - Claims 1, 3-7, and 9-14 are obvious under 35 U.S.C. §103 over Numata in view of Serany, Disston, and Beddow.

• Prior Art Relied Upon: Numata (Japanese Application # 2006-131284), Serany (Patent 3,329,261), Disston (Patent 3,166,189), and Beddow (Patent 4,226,328).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Numata disclosed the foundational medical kit with a single-layer tray having a first compartment for syringes and a second for a catheter assembly. To meet the limitations for a Foley catheter kit, Petitioner asserted a POSITA would look to Serany and Disston, which teach a pre-assembled, closed-system Foley catheter with coiled tubing and a drain bag. This known assembly would replace Numata’s generic catheter. To meet the lubrication limitations, Petitioner cited Beddow, which teaches a dual-use compartment that both stores lubricant and serves as a chamber for lubricating the catheter, arguing it would be obvious to configure Numata's first compartment for this same purpose.
  • Motivation to Combine: A POSITA would combine the references to adapt Numata’s well-packaged kit for the ubiquitous Foley catheterization procedure, thereby leveraging Numata’s organizational and sterility benefits. Key motivations included preventing usage errors by having all components in a single tray and reducing the risk of catheter-associated urinary tract infections (CAUTI) by using a sterile, closed system as taught by Serany and Disston.
  • Expectation of Success: Petitioner asserted the combination involved substituting known elements for their intended functions within a standard kit format, which would lead to predictable results. The modification was a simple application of known techniques to a known device.

Ground 4: Obviousness over Rauschenberger Combination - Claims 13-14 are obvious under 35 U.S.C. §103 over Rauschenberger in view of Serany.

• Prior Art Relied Upon: Rauschenberger (Patent 4,160,505) and Serany (Patent 3,329,261).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner established Rauschenberger as teaching a single-layer urethral catheterization tray, likely for an intermittent catheter, which included a lubricant packet. Petitioner argued it would have been obvious to a POSITA to adapt this kit for Foley catheter use by replacing the intermittent catheter with a Foley catheter and, consequently, adding a water-filled inflation syringe as taught by Serany. It would also have been obvious to replace Rauschenberger’s simple lubricant packet with a more controllable lubricant syringe.
  • Motivation to Combine: The motivation was to broaden the utility of Rauschenberger's tray design to accommodate Foley catheters, a common clinical alternative based on patient need. This modification would require adding an inflation syringe, a component readily supplied by references like Serany. Serany also provided motivation for arranging kit components in a logical, step-by-step order to facilitate the procedure, a principle that would guide the placement of the new syringes.
  • Expectation of Success: Both references are directed to all-in-one catheter kits, making their teachings highly compatible. The proposed substitutions were simple design choices involving replacing one type of known component with another (e.g., packet for syringe, intermittent for Foley catheter) to achieve predictable functionality.

Ground 6: Obviousness over Solazzo Combination - Claims 13-14 are obvious under 35 U.S.C. §103 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 relied on Solazzo’s disclosure of an ergonomic, single-layer tray with separate compartments for syringes and a medical assembly. Petitioner argued it was obvious to replace Solazzo's "tube of lubricant" with a lubricant syringe and to group this syringe with the other required syringes (inflation, irrigation) in a single compartment. Imai was cited to show the known practice of grouping or stacking multiple syringes in one compartment. Serany and Disston taught including a pre-connected, closed-system Foley catheter with coiled tubing and a drain bag.
  • Motivation to Combine: The primary motivation was to improve kit organization and efficiency by grouping like items (syringes) together, a principle taught by Imai and Serany. Incorporating a pre-connected, closed-system catheter from Serany or Disston into Solazzo's tray was motivated by the well-known desire to reduce infection risk and simplify the catheterization procedure for clinicians.
  • Expectation of Success: Petitioner heavily emphasized that the PTAB and Federal Circuit, in prior IPRs on related patents, had already found nearly identical claim limitations obvious over this same combination of prior art, indicating a very high and demonstrated expectation of success.

• Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including Numata/Salvadori/Imai (Ground 3), Rauschenberger/Salvadori (Ground 5), and Solazzo/Salvadori (Ground 7), which primarily added teachings for including swabsticks in the kit and modifying compartment layouts.

4. Arguments Regarding Discretionary Denial

• §325(d) Arguments (Same or Substantially Same Art): Petitioner argued that denial under §325(d) is unwarranted. The petition introduced Numata, a reference not previously before the Office during prosecution. Furthermore, Petitioner contended the Examiner materially erred by not considering the final remand decisions from prior IPRs involving related patents, where claims similar to those in the ’219 patent were found unpatentable over art (Solazzo) that was before the Examiner.
• §314(a) Arguments (Fintiv Factors): Petitioner argued against discretionary denial under Fintiv, asserting that the parallel district court litigation is in a nascent stage with no trial date set, no Markman hearing scheduled, and minimal investment in invalidity-related proceedings. Petitioner further stipulated that it will not pursue in the district court any ground on which IPR is instituted, weighing against denial.

5. Relief Requested

• Petitioner requests the institution of an inter partes review and the cancellation of claims 1-7 and 9-16 of the ’219 patent as unpatentable.