PTAB

IPR2020-00026

Baxter Intl Inc v. Becton Dickinson Co

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Patient Fluid Line Access Valve Antimicrobial Cap/Cleaner
  • Brief Description: The ’828 patent describes a device for disinfecting medical fluid line access valves to prevent infection. The device is a threaded cap containing a pad or sponge impregnated with a cleaning agent, which is covered by a removable seal to maintain sterility and prevent evaporation before use.

3. Grounds for Unpatentability

Ground 1: Claims 1-14 are obvious over Genatempo in view of Menyhay.

  • Prior Art Relied Upon: Genatempo (Patent 4,440,207) and Menyhay (Patent 5,554,135).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of Genatempo and Menyhay disclosed all elements of the challenged claims. Menyhay taught a protective cap with internal threads for engaging a threaded medical port, an internal sponge, and a breakable internal capsule to release an antiseptic solution onto the sponge upon engagement. Genatempo taught a similar protective cap containing a pre-impregnated absorbent material with an antiseptic liquid and, critically, a removable lid or seal to cover the opening, preventing spillage and evaporation. Petitioner asserted that the combination of Menyhay’s threaded cap and sponge with Genatempo’s pre-wetted pad and removable seal renders the claimed invention obvious.
    • Motivation to Combine: A POSITA would combine these references to create a more reliable and effective cleaning cap. The motivation was to overcome a potential failure point in Menyhay, where its internal breakable capsule might not sufficiently wet the sponge. A POSITA would substitute Menyhay’s mechanism with Genatempo’s teaching of pre-impregnating the sponge at the time of manufacture. This modification would necessitate adding a removable seal, as taught by Genatempo, to prevent the pre-wetted sponge from drying out or leaking before use, resulting in a predictably improved device.
    • Expectation of Success: Petitioner contended that a POSITA would have a reasonable expectation of success because the combination involved a simple substitution of one known antiseptic delivery method (Menyhay’s breakable capsule) for another (Genatempo’s pre-wetted sponge), along with the necessary addition of a known sealing element. The components were all simple mechanical elements performing their known functions.

Ground 2: Claims 1-14 are obvious over Connell, Raulerson, and Genatempo.

  • Prior Art Relied Upon: Connell (Application # 2003/0153865), Raulerson (Application # 2006/0030827), and Genatempo (Patent 4,440,207).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued this combination also disclosed all claim elements. Connell taught a fluid connector cleaner with a cap that threadingly mates with a connector and contains a sealed disinfectant. To the extent Connell did not explicitly teach a physical scrubbing action, Raulerson supplied this element by disclosing a luer cleaner with bristles that use rotational energy from a twisting motion to scrub the surfaces of a connector. Genatempo was again relied upon for its teaching of a pre-impregnated absorbent material and a removable lid to seal the cap.
    • Motivation to Combine: A POSITA would be motivated to improve the disinfecting capabilities of the device taught in Connell by incorporating a physical scrubbing mechanism. Raulerson provided a known solution for scrubbing a connector using the same rotational motion employed by Connell. A POSITA would combine these teachings to create a cap that both chemically disinfects and physically scrubs the connector. The motivation to further incorporate Genatempo’s pre-wetted sponge and seal was the same as in Ground 1: to ensure the cleaning agent is reliably present and does not evaporate, thereby improving the overall product.
    • Expectation of Success: Success would be expected as the combination integrated known elements for their established purposes. Combining a chemical disinfectant cap (Connell) with a mechanical scrubbing feature (Raulerson) and a reliable pre-wetted, sealed sponge (Genatempo) was a predictable assembly of complementary technologies to achieve a more thorough cleaning.

  • Additional Grounds: Petitioner asserted that claim 12 is also obvious over the primary combinations of Ground 1 and Ground 2 with the additional teaching of Miyahara (Application # 2004/0111078). Petitioner argued Miyahara demonstrated that using a short thread length (less than one full rotation) was a known and obvious design choice to reduce the number of rotations needed to secure the cap, thereby improving user convenience.

4. Key Claim Construction Positions

  • Petitioner noted that claim terms "length" and "access portion" were construed in a prior IPR for a related patent but contended that its invalidity arguments did not turn on the adoption or rejection of any specific constructions. It proposed that all other terms be given their plain and ordinary meaning.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-14 of Patent 10,159,828 as unpatentable.