C R Bard Inc v. Medline Industries LP

1. Case Identification

• Case #: IPR2019-00036
• Patent #: 9,745,088
• Filed: October 4, 2018
• Petitioner(s): C. R. Bard, Inc.
• Patent Owner(s): Medline Industries, Inc.
• Challenged Claims: 45-58, 60-74, 76-90, and 92

2. Patent Overview

• Title: Medical Procedure Tray
• Brief Description: The ’088 patent discloses a medical procedure kit featuring a single-layer tray with multiple compartments for storing and organizing catheterization devices. The claimed invention centers on a tray containing specific components, including multiple syringes and a medical assembly comprising a Foley catheter pre-connected to a fluid drain bag via coiled tubing.

3. Grounds for Unpatentability

Ground 1: Obviousness over Solazzo, Serany, and Disston - Claims 45-48, 50-51, 55-58, 60-64, 66-67, 71-74, 76-80, 82-83, 87-90, and 92 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: Petitioner argued that Solazzo disclosed the core structure of the invention: a single-layer, multi-compartment tray for a catheterization kit designed to hold syringes and a medical assembly (including a Foley catheter). Petitioner contended that while Solazzo showed the tray, it did not explicitly disclose the claimed closed-system catheter assembly or the sterile packaging. These missing elements, Petitioner asserted, were well-known and taught by Serany and Disston. Both Serany and Disston disclosed catheterization kits containing a Foley catheter pre-connected to a drainage bag (or a collapsible bottle functioning as a bag) via coiled tubing. Furthermore, Serany explicitly taught enclosing the tray in sterile wrap and an outer envelope for shipping and to maintain a sterile field.
  • Motivation to Combine: A POSITA would combine the closed-system catheter of Serany or Disston with Solazzo’s tray to achieve the known benefits of convenience ("ready for use") and reduced infection risk, a primary concern in catheterization procedures. Similarly, a POSITA would find it obvious to package Solazzo's sterile tray using the standard sterile wrap and outer packaging taught by Serany to maintain component sterility during shipping and handling, which is a fundamental requirement for such medical kits.
  • Expectation of Success: The combination involved integrating well-understood components (a closed-system catheter, standard sterile packaging) into a known type of device (a catheterization tray). This would have been a simple substitution of known elements to yield the predictable results of improved safety, convenience, and sterility.

Ground 2: Obviousness over Solazzo, Serany, Disston, and Salvadori - Claims 49, 54, 65, 70, 81, and 86 are obvious over the combination of Ground 1 in view of 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: This ground incorporated the arguments from Ground 1 and added Salvadori to address dependent claims reciting a "specimen jar" and "swabsticks." Petitioner asserted that Salvadori taught a multi-pocket sterile wrapping for a urethral catheterization procedure that explicitly included a specimen bottle and swab sticks, among other components.
  • Motivation to Combine: A POSITA would be motivated to add a specimen jar and swabsticks to the base kit from Ground 1 because they were common, necessary components for catheterization procedures. Including them would allow a practitioner to take a urine sample if clinically needed and to properly cleanse the patient prior to insertion, creating a more comprehensive and functional kit.
  • Expectation of Success: Adding these standard, off-the-shelf components to a catheter tray was a routine and predictable modification.

Ground 3: Obviousness over Solazzo, Serany, Disston, and Franks-Farah - Claims 52-53, 68-69, and 84-85 are obvious over the combination of Ground 1 in view of Franks-Farah.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), Disston (Patent 3,166,189), and Franks-Farah (Patent 6,840,379).

• Core Argument for this Ground:

  • Prior Art Mapping: This ground built upon the base combination of Ground 1 and added Franks-Farah to teach the limitation of "printed instructions for using the single layer tray." Petitioner argued that Franks-Farah disclosed a urinary catheter kit that included detailed, step-by-step printed instructions for performing the procedure, including instructions on lubricating the catheter.
  • Motivation to Combine: It was standard industry practice and an FDA requirement to include adequate directions for use with medical devices. A POSITA would therefore be motivated to add printed instructions, as taught by Franks-Farah, to the base kit to ensure physicians could perform the procedure safely and correctly.
  • Expectation of Success: Adding printed matter to a known product is a simple, predictable step that does not alter the physical operation of the device but ensures its proper use.

• Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 4) for claims 55, 71, and 87 based on the core combination plus Bierman (Application # 2008/0249476) to teach a Foley catheter securement device.

4. Key Claim Construction Positions

• Petitioner asserted that no terms required special construction and that all terms should be given their plain and ordinary meaning. It noted, however, that the cited prior art would render the claims obvious even under the constructions for "Barrier" and "lubricating jelly application chamber" previously proposed by the Patent Owner in co-pending district court litigation.

5. 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 substantively considered by the Examiner during original prosecution. Petitioner contended that although Solazzo was listed in a 375-reference Information Disclosure Statement, the Examiner never mentioned or analyzed it, and thus the core of the petition's invalidity argument was never previously considered by the USPTO.

6. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 45-58, 60-74, 76-90, and 92 of the ’088 patent as unpatentable.