Ivera Medical Corp v. CaTheter Connections Inc

1. Case Identification

• Case #: IPR2014-01124
• Patent #: 8,647,326
• Filed: July 8, 2014
• Petitioner(s): Ivera Medical Corporation
• Patent Owner(s): Catheter Connections, Inc.
• Challenged Claims: 1-9, 12, 14-16

2. Patent Overview

• Title: System of Medical Luer Connector Caps
• Brief Description: The ’326 patent relates to a system of disinfecting caps used to protect the sterility of unconnected medical luer connectors. The system features an assembly of at least two disinfecting caps held together in a pre-use configuration under a common, removable cover.

3. Grounds for Unpatentability

Ground 1: Anticipation by Rogers - Claims 1, 4-9, 12, and 14-16 are anticipated under 35 U.S.C. §102 by Rogers.

• Prior Art Relied Upon: Rogers (Application # 2008/0019889).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Rogers discloses every limitation of the challenged claims. Rogers teaches a cleaning system for medical environments that includes a "plurality of caps" for disinfecting medical implements, explicitly including luer connectors. Petitioner asserted that Rogers describes a single foil seal (the claimed "cover") that "covers the opening of each of the plurality of caps," sealing the chamber of each cap. The disclosure further teaches that individual caps can be selectively removed from this common cover for use. Rogers also discloses all features of the dependent claims, including adhesive covers, antiseptic agents (isopropyl alcohol), and absorbent pads.
  • Key Aspects: The viability of this anticipation ground hinges on Petitioner's argument that the ’326 patent is not entitled to the filing date of its earliest provisional application. This would make the publication date of Rogers prior art under §102(e).

Ground 2: Obviousness over Rogers and Mayoral - Claims 2 and 3 are obvious over Rogers in view of Mayoral.

• Prior Art Relied Upon: Rogers (Application # 2008/0019889), Mayoral (Patent 6,394,983).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Rogers discloses the base system of disinfecting caps as recited in claim 1, but specifically teaches a cap with internal threads for engaging a female luer connector. Challenged claims 2 and 3 depend from claim 1 but add the limitation of threads disposed to engage a male luer connector. Mayoral explicitly discloses a cap designed for this purpose, teaching threads for connecting with a male luer connector.
  • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to modify the Rogers cap using the teachings of Mayoral. Petitioner contended it is a fundamental design principle that male and female connectors require complementary threaded caps. Therefore, adapting the Rogers disinfecting cap to work with male connectors by applying the known threading configuration from Mayoral would have been a simple, predictable reversal of parts to achieve a known function.

Ground 3: Obviousness over Hoang and Lake - Claims 1, 4-9, 12, and 14-16 are obvious over Hoang in view of Lake.

• Prior Art Relied Upon: Hoang (Application # 2007/0112333), Lake (Patent 7,282,186).

• Core Argument for this Ground:

  • Prior Art Mapping: Hoang discloses a disinfecting "cap/cleaner" for fluid line access valves, including luer connectors, that contains the core features of the claimed disinfecting caps (a chamber, an antiseptic pad, and threads). However, Hoang primarily shows a cover over a single cap. Lake addresses the packaging of multiple caps, teaching a method where multiple decontamination devices (disinfecting caps) are joined together on a strip and sealed under a single, removable cover.
  • Motivation to Combine: A POSITA would combine Hoang's disinfecting cap with Lake's packaging method to "maintain an orderly arrangement of multiple cleaning caps which are readily accessible for use." This combination would involve extending Hoang's single cover across multiple caps as taught by Lake, which is a known solution from the analogous art of medical device packaging to solve a known problem.
  • Expectation of Success: The combination of a known device (Hoang) with a known packaging technique (Lake) would have yielded the predictable result of a strip of sterile, individually accessible disinfecting caps.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combining Rogers with Lake as a fallback position (Ground 3), and further combining the primary grounds with Mayoral to address dependent claims 2-3 (Grounds 4 and 6). These grounds relied on similar motivations to combine.

4. Key Claim Construction Positions

• "means for engaging threads of luer connectors" (claims 1, 16): Petitioner argued this term should be construed as "threads that mate with the threads of luer connectors, and equivalents thereof." This construction was adopted by the Examiner during prosecution and is supported by the specification.
• "means for engaging threads... to engage a female luer connector" (claim 2): Petitioner proposed the construction "threads on the interior of the opening of the cap, that mate with the threads of a female luer connector... and equivalents thereof."
• "connection interface" (claim 9): Petitioner asserted this term refers to "the part of a connector cap that connects with another medical implement or connector cap," which is not limited to a threaded connection.

5. Key Technical Contentions (Beyond Claim Construction)

• Priority Date Entitlement: A central contention of the petition is that the ’326 patent is not entitled to the benefit of the filing date of its earliest provisional application (Howlett ’541 provisional). Petitioner argued the provisional application fails to provide adequate written description support for two critical limitations in the issued claims:
  • 1. The specific use of "luer connectors," as the provisional only discloses generic "medical connectors."
  • 2. A "cover extending over... at least two disinfecting caps," as the provisional only discloses a "wrap-around seal" for a nested pair of caps or a cover for a single cap.
• This argument is foundational to establishing the Rogers publication as effective prior art under 35 U.S.C. §102.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-9, 12, and 14-16 of Patent 8,647,326 as unpatentable.