PTAB

IPR2021-01200

Atrium Medical Corp v. Bard Peripheral Vascular Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Implantable Access Port with Radiopaque Identifier
  • Brief Description: The ’022 patent discloses implantable medical access ports designed for power injection of fluids into a patient's bloodstream. The ports include radiopaque identification features, such as alphanumeric characters, that are observable by X-ray after implantation to inform a practitioner that the port is suitable for power injection.

3. Grounds for Unpatentability

Ground 1: Obviousness over Eliasen, Melsky, and Lee - Claims 1-14, 16, and 18-20 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 taught a subcutaneously implantable vascular access port with a body, fluid cavity, and needle-penetrable septum, and that its disclosure of use with an "ambulatory-type pump" rendered it power injectable. To the extent Eliasen was not considered power injectable, Melsky explicitly disclosed an access port with an improved septum retention system designed to withstand high internal pressures (e.g., 200 psi or more), making it suitable for power injection. Lee taught marking implantable medical devices with radiopaque markers, including alphanumeric characters like the letter "E," on the device's outer housing to convey information (such as orientation) to practitioners via X-ray imaging post-implantation. The combination of a power-injectable port (Eliasen, reinforced by Melsky) with radiopaque identifiers (Lee) renders the independent claims obvious.
    • Motivation to Combine: A POSITA would combine Eliasen’s port with Melsky’s high-pressure design to ensure the port could safely withstand the forces of power injection, a common clinical procedure. Petitioner asserted that ensuring patient safety by preventing port fracture or septum blowout provided a strong motivation. A POSITA would have also been motivated to add Lee's radiopaque markings to the combined port for the crucial purpose of identifying it as power-injectable. This would prevent the dangerous misuse of a non-power-injectable port, a known and serious risk.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success, as the combination involved applying known marking techniques (Lee) to a known type of medical device (Eliasen/Melsky) to achieve a predictable and desired safety function.

Ground 2: Obviousness over Bardport, Herts, and Lee - Claims 1-14, 16, and 18-20 are obvious over Bardport in view of Herts and Lee.

  • Prior Art Relied Upon: Bardport (Bardport Website, a collection of webpages from 2002-2003), Herts (a 2001 journal article), and Lee (Patent 5,203,777).
  • Core Argument for this Ground:
    • Prior Art Mapping: The Bardport website disclosed a suite of implantable access ports with a body, septum, and fluid cavity. In a "Frequently Asked Questions" section regarding use with a "Power Injector," Bardport explicitly identified the Herts article as being "on the subject" and "of help." Herts was a published study that concluded power injection of contrast media through Bardport catheters was "feasible and safe," referencing pressure limits of 25 psi. Together, Bardport and Herts taught a power-injectable access port. Lee, as in Ground 1, taught the use of radiopaque alphanumeric markers on implantable devices for post-implantation identification via X-ray.
    • Motivation to Combine: Petitioner argued the motivation to combine Bardport and Herts was exceptionally strong, as Bardport's own website directed a POSITA to the Herts study for information on power injecting with Bard's products. This combination established the power-injectable nature of the base device. A POSITA would have been motivated to combine this power-injectable port with Lee’s radiopaque marking system for the same critical safety reason as in Ground 1: to clearly and reliably identify the port’s capabilities and prevent catastrophic failure from improper use.
    • Expectation of Success: A POSITA would have had a high expectation of success because Bardport already used radiopaque rings on its catheters for visualization, demonstrating familiarity with the technology. Applying Lee's established marking technique to a Bardport port to solve the known problem of identifying power-injectable devices would have been a straightforward and predictable modification.

4. Key Claim Construction Positions

  • "identifying the access port as a power-injectable port": Petitioner dedicated significant argument to construing this and similar phrases as non-limiting printed matter. Petitioner argued that this language merely conveys information to a human practitioner and does not create a new functional or structural relationship with the access port itself. Citing Federal Circuit precedent involving the same patent owner (C.R. Bard, Inc. v. AngioDynamics, Inc.) and the Board's findings in a prior reexamination of the ’022 patent, Petitioner contended that this claim language should be afforded no patentable weight in the obviousness analysis.
  • "access port": Consistent with a prior Federal Circuit ruling on the ’022 patent, Petitioner agreed that the challenged claims should be construed to require a "power-injectable access port," meaning a port that can be injected and pressurized by mechanical assistance.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-14, 16, and 18-20 of the ’022 patent as unpatentable under 35 U.S.C. §103.