C R Bard Inc v. Medline Industries Inc

1. Case Identification

• Case #: IPR2019-00109
• Patent #: 9,795,761
• Filed: October 24, 2018
• Petitioner(s): C. R. Bard, Inc.
• Patent Owner(s): Medline Industries, Inc.
• Challenged Claims: 1-19, 22-25

2. Patent Overview

• Title: Medical Kit, Packaging System, Instruction Insert, and Associated Methods
• Brief Description: The ’761 patent describes a medical kit, primarily for urinary catheterization procedures, comprising a multi-compartment tray for holding a Foley catheter and syringes. A key feature is the inclusion of a "patient aid" with post-procedure instructions for patient care, such as ensuring aseptic techniques and monitoring urine flow.

3. Grounds for Unpatentability

Ground 1: Claims 1-9, 10-19, and 23-25 are obvious over Solazzo, 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: Petitioner asserted that Solazzo disclosed the core structural elements of the claimed invention: a single-layer tray with multiple compartments configured to hold a Foley catheter and syringes. Solazzo also taught a terraced, non-flat bottom surface within a compartment, allowing two syringes to be supported at different heights based on their order of use (e.g., a lubricant syringe used before an inflation syringe). Serany taught the packaging aspects, disclosing a multi-compartment tray enclosed within a sterile wrap, which is further encased in a sealed outer bag to maintain sterility. Finally, Franks-Farah taught a urinary catheter kit that included a "patient aid" with detailed, step-by-step instructions covering both procedural and post-procedural care, such as aseptic techniques (hand washing) and monitoring urine flow, which Petitioner argued was analogous to the patient aid of the ’761 patent.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine Solazzo's functional tray with Serany's well-known sterile packaging (wrap and sealed bag) to achieve the predictable result of a sterile catheterization kit. A POSITA would be further motivated to include the patient aid of Franks-Farah in Solazzo's tray to enhance patient safety. Providing clear instructions on aseptic techniques and post-procedure care directly addresses the known and critical risk of catheter-associated urinary tract infections.
  • Expectation of Success: Combining these known elements would have been straightforward. Each component—the tray, the sterile packaging, and the instructional aid—would perform its known function in a predictable manner, leading to a high expectation of success.

Ground 2: Claims 3, 12, 22, and 24 are obvious over Solazzo, Serany, Franks-Farah, and Disston

• Prior Art Relied Upon: Solazzo (Patent 7,278,987), Serany (Patent 3,329,261), Franks-Farah (Patent 6,840,379), and Disston (Patent 3,166,189).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination in Ground 1 to address dependent claims reciting specific component placements, such as a hand sanitizer or printed instructions. The base combination of Solazzo, Serany, and Franks-Farah provided the tray, packaging, hand sanitizer, and instructions. The incremental reference, Disston, was introduced for its teaching of arranging kit components in a specific procedural order to be "most conveniently available when the container is opened." Disston explicitly taught arranging items to guide the user through a procedure, a concept now known as design affordance.
  • Motivation to Combine: A POSITA, guided by the design principles taught in Disston, would be motivated to place components like the hand sanitizer (claim 3) or printed instructions (claim 22) between the outer sealed bag and the inner sterile wrap. This placement ensures the user encounters these items first upon opening the package, prompting them to sanitize their hands and read instructions before accessing the sterile components within the wrap. This arrangement logically follows the procedural steps of a catheterization, enhancing convenience and safety.
  • Expectation of Success: Arranging components within a package based on their order of use was a well-understood design principle. Applying Disston's teachings to the kit established by the other references was a simple, common-sense design choice that would have yielded predictable results.

4. Key Claim Construction Positions

• Petitioner argued that the challenged claims should be given their plain and ordinary meaning and that no special constructions were required to find the claims invalid.
• Petitioner noted that Patent Owner had proposed constructions in district court litigation for terms including "mnemonic device" (a feature intended to assist memory, such as ordering items) and "lubricating jelly application chamber" (a compartment where lubrication is applied). Petitioner contended that its invalidity arguments would succeed even under Patent Owner's proposed constructions.

5. Key Technical Contentions (Beyond Claim Construction)

• Petitioner's central legal argument was that the "patient aid" and "printed instructions" limitations should be given no patentable weight. Citing In re Ngai, Petitioner argued that one cannot patent a known product (a catheter tray) by simply attaching printed instructions to it.
• Petitioner further argued that even if the patient aid substrate were considered, its content (e.g., post-procedure information) constitutes non-functional descriptive matter that cannot be relied upon for patentability, a position the Patent Trial and Appeal Board (PTAB) had previously taken during the original prosecution of the ’761 patent family.

6. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) was inapplicable. It contended that the current petition raised art and arguments not substantially the same as those considered during the original examination.
• Specifically, Petitioner asserted that while the Examiner had considered hundreds of references, he never substantively addressed Franks-Farah, which taught the critical "patient aid" limitations. Petitioner argued Franks-Farah was materially different from the art the Examiner relied upon for allowance, thus warranting institution.

7. Relief Requested

• Petitioner requested institution of an inter partes review (IPR) and cancellation of claims 1-19 and 22-25 of the ’761 patent as unpatentable.