CR Bard Inc v. Medline Industries LP

1. Case Identification

• Case #: IPR2025-00402
• Patent #: 11,661,220
• Filed: January 3, 2025
• Petitioner(s): C.R. Bard, Inc.
• Patent Owner(s): Medline Industries, LP
• Challenged Claims: 8-22

2. Patent Overview

• Title: Storage Container for a Catheter and Related Medical Devices
• Brief Description: The ’220 patent is directed to a medical procedure kit comprising a multi-compartment, single-layer tray for storing and organizing components for a catheterization procedure, such as a Foley catheter, syringes, and swabsticks.

3. Grounds for Unpatentability

Ground 1: Obviousness over Numata Combination - Claims 16-22 are obvious over Numata, Serany, Disston, Beddow, Imai, and Salvadori.

• Prior Art Relied Upon: Numata (Japanese Application # 2006-131284), Serany (Patent 3,329,261), Disston (Patent 3,166,189), Beddow (Patent 4,226,328), Imai (Japanese Application # 2007-229520), and Salvadori (Patent 5,931,303).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Numata disclosed the basic medical kit with a single-layer tray containing at least two compartments for syringes and a catheter. The combination with Imai rendered it obvious to add a third compartment to better organize components like forceps and cotton (or swabsticks) and to strengthen the tray. Serany and Disston disclosed including a closed-system Foley catheter pre-coupled to a fluid drain bag via coiled tubing. Beddow taught that a tray compartment could be used as a lubricating jelly application chamber, where the catheter is passed through lubricant dispensed in the same compartment where the lubricant container is stored. Finally, Salvadori taught replacing forceps and cotton with more convenient swabsticks.
  • Motivation to Combine: A POSITA would combine these references to create an improved, comprehensive Foley catheter kit. The motivation was to take the single-tray packaging solution from Numata, which prevents usage errors, and apply it to the common Foley catheter procedure taught by Serany and Disston. A POSITA would incorporate Imai’s teachings to improve organization, use Beddow’s technique for convenient lubrication, and substitute Salvadori’s modern swabsticks for older components to improve ease of use.
  • Expectation of Success: Petitioner asserted a high expectation of success, as the combination involved applying known techniques (e.g., adding compartments, substituting components like swabsticks for cotton) to a known device (a catheter kit) to achieve predictable results.

Ground 2: Obviousness over Rauschenberger Combination - Claims 16-21 are obvious over Rauschenberger, Serany, and Salvadori.

• Prior Art Relied Upon: Rauschenberger (Patent 4,160,505), Serany (Patent 3,329,261), and Salvadori (Patent 5,931,303).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Rauschenberger taught a single-layer urethral catheterization tray with multiple compartments, including a channel for a catheter that also serves as a lubricating jelly application chamber. However, Rauschenberger likely disclosed a kit for an intermittent catheter. To adapt this for the more common indwelling Foley catheter, a POSITA would look to Serany, which taught including an inflation syringe and a pre-assembled Foley catheter with coiled tubing and a drain bag. The combination with Salvadori rendered it obvious to replace Rauschenberger’s absorbent pads and forceps with swabsticks for cleaning the patient.
  • Motivation to Combine: The primary motivation was to adapt Rauschenberger's tray, which advantageously allows procedural steps to be performed within the tray itself, for use with a Foley catheter. A POSITA would be motivated to include the necessary inflation syringe and closed-system catheter from Serany to perform this common procedure. Additionally, a POSITA would substitute the cleansing components with the more convenient swabsticks from Salvadori.
  • Expectation of Success: Success was expected because the combination involved substituting known components (a Foley catheter for an intermittent one, a syringe for a lubricant packet, swabsticks for pads) to equip a known tray for a well-understood medical procedure.

Ground 3: Obviousness over Solazzo Combination - Claims 16-21 are obvious over Solazzo, Serany, Disston, and Salvadori.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), Disston (Patent 3,166,189), and Salvadori (Patent 5,931,303).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued this ground based on art the Board previously found to invalidate related patents. Solazzo disclosed an ergonomic, single-layer tray with multiple compartments, an inflation syringe, an irrigation syringe, and lubricating wells. Serany and Disston taught including a pre-connected, closed-system Foley catheter and drain bag, which reduces infection risk. Petitioner asserted that a POSITA would place swabsticks, taught by Salvadori, into one of Solazzo’s separate compartments (e.g., lubricating wells 31 or 33) to keep them separate from other components and logically organized for their early use in the procedure.
  • Motivation to Combine: A POSITA would be motivated to enhance the ergonomic Solazzo tray by incorporating a pre-connected, closed-system Foley catheter from Serany/Disston to reduce infection risk. There was further motivation to add swabsticks from Salvadori for patient cleaning and to place them in one of Solazzo’s empty wells to improve organization and facilitate the proper sequence of use.
  • Expectation of Success: Petitioner argued for a reasonable expectation of success, noting that the PTAB and Federal Circuit had previously considered these references and found they rendered similar claims obvious.

• Additional Grounds: Petitioner asserted additional obviousness challenges against claims 8-15 based on Numata, Serany, Disston, and Beddow, relying on similar arguments to those presented in Ground 1.

4. Arguments Regarding Discretionary Denial

• Arguments against §325(d) Denial: Petitioner argued denial is improper because key prior art and arguments were not before the Examiner. Specifically, the Numata reference is new. While Solazzo and Rauschenberger were of record, the Examiner did not have the benefit of the Board’s remand Final Written Decisions (FWDs) from prior IPRs, which found substantially similar claims in a related patent obvious over Solazzo. Petitioner contended the Examiner made clear errors, such as finding Solazzo only taught one syringe, a conclusion directly contrary to the remand FWDs.
• Arguments against §314(a) Fintiv Denial: Petitioner argued the Fintiv factors weigh against discretionary denial. The parallel district court litigation is in a very early stage, with no trial date set, no claim construction order issued, and no significant investment in developing invalidity contentions. Petitioner also stipulated that it will not pursue the same invalidity grounds in the district court if the IPR is instituted, which mitigates concerns of duplicative efforts.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 8-22 of the ’220 patent as unpatentable.