C R Bard Inc v. Medline Industries Inc

1. Case Identification

• Case #: IPR2019-00208
• Patent #: 9,808,400
• Filed: November 7, 2018
• Petitioner(s): C. R. Bard, Inc.
• Patent Owner(s): Medline Industries, Inc.
• Challenged Claims: 13, 14, 16, and 17

2. Patent Overview

• Title: Catheter Tray, Packaging System, And Associated Methods
• Brief Description: The ’400 patent discloses a kit for storing medical devices, specifically a catheterization kit. The invention centers on a single-level tray with multiple compartments containing syringes and a pre-assembled catheter assembly, which includes an indwelling catheter, coiled tubing, and a fluid receptacle with an anti-reflux device.

3. Grounds for Unpatentability

Ground 1: Obviousness over Solazzo, Serany, and Boedecker

• Claims 13, 14, 16, and 17 are 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: Petitioner argued that Solazzo teaches the foundational kit, including a single-level tray with first and second compartments, a barrier between them, and separate syringes for inflation and lubricant (or a tube of lubricant, which Petitioner argued is an obvious substitute for a syringe). To arrive at the claimed catheter assembly, Petitioner asserted that Serany teaches a pre-connected, "closed-system" Foley catheter with coiled tubing and a flexible drainage receptacle, all packaged within a tray. Finally, Petitioner argued that Boedecker teaches adding an anti-reflux valve to a flexible drainage bag to prevent urine backflow. The combination of these elements, packaged within a sterile wrap as taught by Serany (for claims 16-17), allegedly renders the challenged claims obvious.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Solazzo's tray with Serany's closed-system catheter for convenience ("ready for use") and to reduce the known risk of Catheter-Associated Urinary Tract Infections (CAUTIs), a benefit explicitly taught by Serany. A POSITA would further incorporate Boedecker's anti-reflux valve into Serany's flexible bag because Boedecker expressly addresses the problem of urine reflux in such bags and the associated risk of retrograde bacterial movement.
  • Expectation of Success: Combining these known elements would have yielded predictable results, as it involved the simple substitution of one known catheter system for another in a standard tray and adding a known valve to a known receptacle to solve a known problem.

Ground 2: Obviousness over Solazzo, Disston, and Boedecker

• Claims 13 and 14 are obvious over Solazzo in view of Disston and Boedecker.
• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Disston (Patent 3,166,189), and Boedecker (Patent 3,965,900).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground presented a similar argument to Ground 1, but substituted Disston for Serany as the source for the closed-system catheter. Petitioner asserted Solazzo again teaches the base multi-compartment tray and syringes. Disston, like Serany, teaches a complete, pre-assembled, "ready for use" catheterization kit with a Foley catheter, coiled drainage tube, and a flexible drainage bag. Boedecker again provides the teaching of an anti-reflux device for the flexible bag.
  • Motivation to Combine: The motivation was identical to that in Ground 1. A POSITA would be motivated to incorporate Disston's convenient, pre-assembled closed-system catheter into Solazzo's tray to reduce procedural steps and, critically, to lower the risk of CAUTI. The motivation to add Boedecker's anti-reflux valve was also the same: to prevent the well-understood problem of urine backflow from the flexible drainage bag taught by Disston.
  • Expectation of Success: The combination was presented as a straightforward application of known technologies to achieve the predictable benefits of convenience and improved patient safety.

Ground 3: Obviousness over Solazzo and Nursing Standard

• Claims 13, 14, 16, and 17 are obvious over Solazzo in view of Nursing Standard.

• Prior Art Relied Upon: Solazzo (Patent 7,278,987) and Nursing Standard (an article published March 2009).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that this combination renders the claims obvious by showing the claimed invention was merely the implementation of the standard of care at the time. Solazzo provides the multi-compartment tray and syringes. The Nursing Standard article described that "all-in-one Foley trays" containing a "pre-connected catheter and drainage bag" (a "closed system") were common practice by 2009. The article explicitly states that using such closed systems dramatically reduces CAUTIs and that the "majority of bags...have an anti-reflux valve to prevent the backflow of urine."
  • Motivation to Combine: A POSITA would have been strongly motivated to implement the teachings of Nursing Standard in a tray kit like Solazzo's. The motivation was not just a simple design choice but a matter of adhering to the standard clinical practice for infection control. The article itself provided the express motivation by highlighting the significant reduction in infection rates (from 97% with open systems to 8-15% with closed systems).
  • Expectation of Success: A POSITA would have had a high expectation of success in combining a standard-of-care catheter assembly with a standard catheter tray, as this simply reflected what was already being done in the field.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including grounds that substituted Peterson (Patent 4,334,537) for Boedecker to teach an anti-reflux valve and a four-part combination of Solazzo, Disston, Boedecker, and Serany for claims 16 and 17.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. § 325(d) would be inappropriate. The petition asserted that its primary reference, Solazzo, is materially different from and not cumulative of the art considered during the original examination of the ’400 patent. Furthermore, Petitioner argued that neither Solazzo nor the specific arguments presented were raised in prior IPRs involving the Patent Owner, making the petition substantially new.

5. Relief Requested

• Petitioner requests the institution of an inter partes review and the cancellation of claims 13, 14, 16, and 17 of Patent 9,808,400 as unpatentable under 35 U.S.C. § 103.