C R Bard Inc v. Medline Industries LP

1. Case Identification

• Case #: IPR2019-00223
• Patent #: 9,808,596
• Filed: November 7, 2018
• Petitioner(s): C. R. Bard, Inc.
• Patent Owner(s): Medline Industries, Inc.
• Challenged Claims: 7-16, 21-22

2. Patent Overview

• Title: Catheter Tray, Packaging System, And Associated Methods
• Brief Description: The ’596 patent discloses a kit for storing medical devices, specifically a single-level catheterization tray with multiple compartments. The tray is designed to hold components such as a Foley catheter assembly and multiple syringes (e.g., for inflation and lubrication) in an organized manner intended to guide a user through a procedure.

3. Grounds for Unpatentability

Ground 1: Claims 7, 9-16, 21, and 22 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 taught the core claimed invention: a single-level catheterization tray with a first compartment and a second compartment, capable of holding an inflation syringe and a Foley catheter. Solazzo’s tray also featured a terraced bottom, creating different elevations. Petitioner asserted that Serany, an early patent for sterile catheter packages, supplied the remaining elements. Specifically, Serany taught a "ready for use" kit including a Foley catheter pre-connected to a fluid receptacle (drainage bottle) via coiled tubing. Serany also disclosed enclosing the tray in a sterile wrap that unfolds to create a sterile field.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the teachings to improve safety and efficiency. The primary motivation was to reduce the risk of catheter-associated urinary tract infections (CAUTIs), a known problem, by incorporating Serany’s pre-connected, closed-system catheter into Solazzo’s organized tray. A secondary motivation was convenience; a pre-connected system reduces procedural steps. Serany’s teaching of arranging components in their "proper order of use" would have motivated a POSITA to place syringes at different heights in Solazzo's terraced first compartment to function as a mnemonic device, as claimed.
  • Expectation of Success: A POSITA would have a high expectation of success, as the combination involved placing a well-known closed-system catheter (Serany) into a conventional multi-compartment tray (Solazzo) to achieve the predictable benefits of sterility and organization.

Ground 2: Claim 8 is obvious over Solazzo in view of Serany and Boedecker.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), and Boedecker (Patent 3,965,900).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination of Solazzo and Serany to address claim 8, which specifically required that the tube be attached to the fluid receptacle via an "anti-reflux device." Petitioner argued that Boedecker explicitly taught an anti-reflux valve for use with flexible urine collection bags.
  • Motivation to Combine: The motivation was expressly stated in Boedecker: to prevent the reflux of urine from the collection bag back into the catheter and bladder, which could cause trauma and "retrograde bacterial movement." A POSITA, having combined Solazzo and Serany to create a kit with a flexible drainage receptacle, would have been motivated to incorporate Boedecker’s known solution to address the known and dangerous problem of urine reflux.
  • Expectation of Success: The combination was a simple substitution of one known component (Serany’s standard drainage bag) for another (Boedecker’s bag with an integrated anti-reflux device) to achieve the predictable result of preventing reflux.

Ground 3: Claims 7, 9, 11-16, and 22 are obvious over Solazzo in view of Disston.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987) and Disston (Patent 3,166,189).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground presented an alternative to Ground 1, using Disston instead of Serany. Petitioner argued Disston, like Serany, was a well-known example of a complete, pre-assembled catheterization package. Disston taught a single-level tray containing a Foley catheter pre-connected via coiled tubing to a drainage bag (fluid receptacle), with components "arranged in such order and position as to be most conveniently available."
  • Motivation to Combine: The motivations were nearly identical to those in Ground 1. A POSITA would be motivated to incorporate Disston's convenient, "ready for use" closed-system catheter into Solazzo's well-designed multi-compartment tray to reduce infection risk and simplify the catheterization procedure. Disston's emphasis on arranging components for convenient, ordered use would motivate arranging the syringes in Solazzo's tray by height to guide the user.
  • Expectation of Success: The combination of Disston's pre-assembled catheter system with Solazzo's tray was a predictable integration of known elements from analogous art to create an improved catheterization kit.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Solazzo, Disston, and Boedecker (Ground 4) and Solazzo, Disston, and Serany (Ground 5), which relied on similar arguments and motivations for combining the references.

4. Key Technical Contentions (Beyond Claim Construction)

• Petitioner argued that apparatus claims reciting functional limitations, such as a compartment "configured to receive lubricating jelly" (claim 14) or defining a "mnemonic device" (claim 15), do not differentiate the kit from prior art that discloses the same physical structure. If the prior art tray (e.g., Solazzo) has a compartment with the same structure, it is inherently capable of performing the recited function, rendering the limitation met.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. § 325(d) would be inappropriate. The petition asserted that the primary reference, Solazzo, was materially different from and not cumulative of the art considered during the original examination of the ’596 patent. Specifically, the Examiner did not consider any reference disclosing a single-level Foley catheter tray with multiple compartments and syringes, which is the core teaching of Solazzo.

6. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 7-16, 21, and 22 of the ’596 patent as unpatentable.