C R Bard Inc v. Medline Industries LP

1. Case Identification

• Case #: IPR2019-00035
• Patent #: 9,745,088
• Filed: October 4, 2018
• Petitioner(s): C. R. Bard, Inc.
• Patent Owner(s): Medline Industries, Inc.
• Challenged Claims: 1-2, 6-10, 16-19, 25-44

2. Patent Overview

• Title: Tray for Storing Medical Devices
• Brief Description: The ’088 patent relates to a medical procedure kit with a single-layer tray for storing catheterization devices. The tray features multiple compartments and a "stair-stepped" bottom surface designed to hold syringes at different heights, arranged according to their order of use to serve as a mnemonic device.

3. Grounds for Unpatentability

Ground 1: Obviousness over Solazzo and Serany - Claims 1-2, 6-10, 16-17, 25-32, and 36-41 are obvious over Solazzo in view of Serany.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987) and Serany (Patent 3,329,261).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Solazzo, which discloses an ergonomic, single-layer catheterization tray, teaches the core structural elements of the claims. This included a tray with multiple compartments and a "terraced" bottom surface that supports medical devices (an inflation syringe and a tube of lubricant) at different heights. Petitioner asserted this terraced bottom is structurally identical to the claimed "stair-stepped" member and inherently functions as the claimed "mnemonic device." It further argued that substituting Solazzo's lubricant tube with a known lubricant syringe would have been an obvious design choice. Serany, a 1960s patent disclosing a sterile catheterization package, was cited to supply the well-known elements of enclosing a tray in a sterile wrap and an outer packaging envelope, features not detailed in Solazzo.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Solazzo's tray with Serany's standard packaging to maintain the sterility of the kit's components and contain them during shipping, a predictable and necessary step for any such medical product. Furthermore, a POSITA would be motivated by Serany's explicit teaching of arranging components in a logical, step-by-step order to facilitate the procedure.
  • Expectation of Success: The combination involved applying a well-known packaging solution (Serany) to a medical tray (Solazzo). A POSITA would have had a high expectation of success as this would predictably result in a sterile, ready-to-use kit without altering the function of the individual components.

Ground 2: Obviousness over Solazzo, Serany, and Franks-Farah - Claims 18-19 and 35 are obvious over Solazzo in view of Serany and Franks-Farah.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), and Franks-Farah (Patent 6,840,379).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the Solazzo and Serany combination to address claims requiring "printed instructions." Petitioner contended the underlying physical kit was already rendered obvious. Franks-Farah was added for its express disclosure of a urinary catheter kit that includes "extremely detailed and specific step-by-step instructions," including how to apply lubricating jelly from a container.
  • Motivation to Combine: A POSITA would be motivated to include the printed instructions taught by Franks-Farah with the Solazzo/Serany kit to ensure the end-user performs the catheterization procedure safely and correctly. Providing instructions with a medical device kit was a common, logical, and well-established practice to improve usability and reduce the risk of procedural error.
  • Key Aspects: Petitioner also argued that adding printed matter to an otherwise known product is generally insufficient to confer patentability.

Ground 3: Obviousness over Solazzo, Serany, and Disston - Claims 33-34 and 42 are obvious over Solazzo in view of Serany and Disston.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), and Disston (Patent 3,166,189).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed limitations requiring the "Foley catheter coupled to a fluid bag" to form a closed-system kit. While Solazzo taught a tray with a Foley catheter, Petitioner argued it did not explicitly show a pre-connected drainage bag. Both Serany and Disston were cited for teaching pre-assembled, closed-system catheter kits where the catheter is connected to a drainage bag (Disston) or collapsible bottle (Serany) to create a sterile, "ready for use" system.
  • Motivation to Combine: A POSITA would combine the closed-system catheter assembly of Serany and Disston with Solazzo's tray for compelling reasons known in the art. This included reducing the risk of catheter-associated urinary tract infections (CAUTIs), a primary clinical benefit of closed systems, and improving convenience for the healthcare provider by eliminating assembly steps.
  • Expectation of Success: A POSITA would have reasonably expected success in placing a known closed-system catheter into a known catheter tray, as it was a simple combination of compatible components to achieve the predictable advantages of enhanced safety and ease of use.
• Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations of Solazzo, Serany, Franks-Farah, and Disston but relied on similar theories for adding printed instructions and other known kit components.

4. Key Claim Construction Positions

• Petitioner contended that no special claim constructions were necessary and that terms should be given their plain and ordinary meaning. It noted, however, that its obviousness arguments would prevail even under the Patent Owner's proposed constructions from related litigation, including for:
  • mnemonic device: "feature intended to assist the memory, such as ordering items left to right or top to bottom."
  • catheter assembly: "a medical device that includes a Foley catheter connected via coiled tubing to a drainage receptacle."

5. Key Technical Contentions (Beyond Claim Construction)

• Petitioner argued that functional language recited in the apparatus claims does not patentably distinguish the kit from the prior art. For example, it asserted that if a prior art tray has the same physical structure as the claimed tray (e.g., a stair-stepped bottom), calling that structure a "mnemonic device" or a compartment a "lubricating jelly application chamber" based on its intended use does not render the apparatus novel or non-obvious.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) was inappropriate because the primary reference, Solazzo, was materially different from the art the Examiner substantively considered during prosecution. It stated that although Solazzo was cited in a lengthy Information Disclosure Statement (IDS) with 375 references, the Examiner never discussed it or applied it to the claims. Therefore, the core arguments and prior art combination presented in the petition were not previously before the Patent Office.

7. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-2, 6-10, 16-19, and 25-44 of the ’088 patent as unpatentable.