PTAB

IPR2021-01199

Atrium Medical Corp v. Bard Peripheral Vascular Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Implantable Access Port with Radiopaque Identification
  • Brief Description: The ’302 patent discloses subcutaneously implantable venous access ports designed to allow medical practitioners to infuse fluids or draw blood. The claimed ports are specifically designed for power injection (i.e., injection by mechanical assistance) and include radiopaque alphanumeric characters that are visible on an X-ray to identify the port as being power-injectable after implantation.

3. Grounds for Unpatentability

Ground 1: Claims 1-10 are obvious over Eliasen in view of Melsky and Lee

  • Prior Art Relied Upon: Eliasen (Application # 2004/0204692), Melsky (Patent 5,045,060), and Lee (Patent 5,203,777).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Eliasen disclosed a subcutaneously implantable vascular access port with the core structural features of claim 1, including a housing, needle-penetrable septum, and a cap. Petitioner asserted that Eliasen’s disclosure of use with an "ambulatory-type pump" rendered its port power-injectable. To strengthen this point, Petitioner introduced Melsky, which explicitly taught an access port with an improved septum retention system capable of withstanding high internal pressures (200 psi or more), making it suitable for power injection. Finally, Lee was cited for its disclosure of applying radiopaque alphanumeric markers (such as the letter “E”) to implantable medical devices to convey information, such as orientation, to a practitioner via X-ray post-implantation.
    • Motivation to Combine: A POSITA would combine Eliasen’s port with Melsky’s high-pressure design to ensure the port was robust enough for power injections, a known application for such devices. The primary motivation to then add Lee’s radiopaque marking system was patient safety. Properly identifying a port as power-injectable is critical to prevent a practitioner from using a standard port for a high-pressure injection, which could cause the device to fracture, leading to serious injury or death.
    • Expectation of Success: Petitioner contended that a POSITA would have had a reasonable expectation of success, as the combination involved applying a known marking technology (Lee) to an improved access port (Eliasen/Melsky) to achieve a predictable and highly desirable result (clear identification for safe use).

Ground 2: Claims 1-10 are obvious over Bardport in view of Lee (and Herts)

  • Prior Art Relied Upon: Bardport (a collection of publicly available webpages from Bardaccess.com circa 2003), Lee (Patent 5,203,777), and Herts (a Feb. 2001 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner alleged that the Bardport webpages disclosed a commercially available, implantable access port with all the required structural features, including a housing, base, septum, and cap. To establish that the Bardport was power-injectable, Petitioner pointed to Bardport’s own recommendation of 25 psi for its products and its specific reference to the Herts article. The Herts article confirmed that power injection of contrast media using Bardport catheters was "feasible and safe." With Bardport established as the base power-injectable port, Lee was again relied upon for its teaching of adding radiopaque alphanumeric characters to implanted devices for identification.
    • Motivation to Combine: A POSITA would be motivated to combine the teachings for the same critical safety reasons outlined in Ground 1. Given the known dangers of improper port usage, a POSITA would have sought to add a clear, post-implantation identification feature to the known power-injectable Bardport device. Petitioner noted that Bardport already disclosed using a "radiopaque ring" for visualization, making the application of Lee's more specific alphanumeric markers for identification a small and logical step.
    • Expectation of Success: Because Lee taught a broadly applicable marking system and Bardport was a well-defined existing product, a POSITA would have had a high degree of confidence that adding radiopaque alphanumeric characters to the Bardport housing would be successful and effective.

4. Key Claim Construction Positions

  • "convey to a practitioner..." (Printed Matter Doctrine): Petitioner argued that claim limitations requiring the radiopaque characters to "convey," "indicate," or "identify" that the port is power-injectable constitute non-limiting printed matter. Citing prior Board and Federal Circuit decisions, Petitioner asserted this language merely describes the information's content without creating a new functional relationship with the substrate (the port itself). Therefore, this language should be afforded no patentable weight, meaning the prior art need only disclose a power-injectable port with radiopaque characters, not that the characters serve their intended informational purpose.
  • "venous access port assembly": Relying on a prior Federal Circuit ruling involving the ’302 patent, Petitioner argued that all challenged claims should be construed to require that the "claimed access port is power injectable." This construction means that any prior art used must disclose a port that can be injected and pressurized by mechanical assistance, a key issue that was central to the petition's arguments and prior art selection.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-10 of Patent 7,785,302 as unpatentable under 35 U.S.C. §103.