PTAB

IPR2021-01197

Atrium Medical Corp v. Bard Peripheral Vascular Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Access Port
  • Brief Description: The ’615 patent relates to a medical access port for subcutaneous implantation. The port is designed to withstand high pressures for power injection of fluids and includes specific structural features, such as concave sides, intended to allow a practitioner to identify the port as being power-injectable by palpation after it has been implanted.

3. Grounds for Unpatentability

Ground 1: Claims 8 and 11 are obvious over Reuter, Sanfilippo, and Melsky.

  • Prior Art Relied Upon: Reuter (European Application # 12386820), Sanfilippo (Patent 5,919,160), and Melsky (Patent 5,045,060).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of Reuter and Sanfilippo, which the Board and Federal Circuit previously reviewed, discloses all limitations of claim 8 except for the requirement that the port be power-injectable. Reuter taught the basic structure of an implantable port with a body, septum, and concave cut-outs on its base plate for handling. Sanfilippo taught using such concave indentations as a structural feature for post-implantation tactile identification, allowing a user to differentiate between types of ports. The critical missing element, Petitioner asserted, is supplied by Melsky, which explicitly discloses a high-pressure, power-injectable access port capable of withstanding pressures of 200 psi or more, remedying the deficiency identified in the prior reexamination. For method claim 11, the combination similarly taught the steps of identifying a port type via a structural feature, with Melsky providing the teaching of a power-injectable port.
    • Motivation to Combine: A POSITA would combine the teachings of Reuter and Sanfilippo to create a port with tactile identification features, a motivation previously affirmed by the Board. Petitioner contended a POSITA would be further motivated to incorporate Melsky’s high-pressure, power-injectable design because power injection for procedures like CT scans was a well-known clinical need. Given the significant danger of using a non-power-injectable port for a high-pressure injection, there was a strong motivation to create ports that were both power-injectable and clearly identifiable as such to ensure patient safety.
    • Expectation of Success: A POSITA would have a reasonable expectation of success. The combination involved applying Melsky’s known principles for constructing a robust, power-injectable port to the known port design of Reuter, which already included the concave identification features taught by Sanfilippo. Melsky demonstrated that power-injectable ports could be constructed without compromising basic functionality, making the integration of these known features predictable.

Ground 2: Claim 9 is obvious over Reuter, Sanfilippo, Melsky, and Bunodiere.

  • Prior Art Relied Upon: Reuter (European Application # 12386820), Sanfilippo (Patent 5,919,160), Melsky (Patent 5,045,060), and Bunodiere (Application # 2005/0075614).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination in Ground 1 to address the additional limitation of dependent claim 9, which requires the port body to have a "generally triangular exterior." Petitioner asserted that Bunodiere explicitly taught an implantable access port with a substantially triangular base and casing.
    • Motivation to Combine: A POSITA would combine Bunodiere with the other references to gain the known benefits of a triangular shape. Bunodiere explained that a triangular exterior helps minimize patient discomfort and prevents the implanted port from rotating or migrating beneath the skin. This modification represented a simple and well-understood design choice to improve the stability and comfort of the power-injectable, identifiable port established by the combination of Reuter, Sanfilippo, and Melsky. The Board had previously found in the reexamination that modifying a port to have a triangular shape as taught by Bunodiere would have been obvious.
    • Expectation of Success: A POSITA would expect success in modifying the shape of the port to be triangular. This change in the external housing shape is a simple design modification that would not interfere with the internal power-injection mechanism taught by Melsky or the external concave identification features taught by Reuter and Sanfilippo.

4. Key Claim Construction Positions

  • "identifying the access port as being power injectable": Petitioner argued that this phrase, consistent with a prior Board construction, should be interpreted to require "structural features capable of identifying an access port as power injectable after implantation." This construction does not require proof that a specific feature was actually used in practice to identify such ports, only that it was capable of doing so. This interpretation is critical to Petitioner's argument that the known concave cut-outs from Reuter and Sanfilippo satisfy the limitation.
  • "access port": Petitioner asserted that, based on a prior Federal Circuit ruling concerning the challenged claims, the term "access port" must be construed to mean a "power-injectable" access port. This construction was central to the prior appeal and remand, and Petitioner's inclusion of Melsky as prior art was specifically intended to meet this narrowed construction.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 8, 9, and 11 of the ’615 patent as unpatentable.