LifeScan Inc v. Facet Technologies LLC

1. Case Identification

• Case #: IPR2023-00713
• Patent #: 8,840,635
• Filed: March 20, 2023
• Petitioner(s): LifeScan, Inc.
• Patent Owner(s): Facet Technologies, LLC
• Challenged Claims: 1, 4, and 9-15

2. Patent Overview

• Title: Protective sterility cap for a lancet
• Brief Description: The ’635 patent discloses a protective sterility cap for a single-use medical lancet. The cap features a primary sheath to cover the sharp tip of an unused lancet, a secondary sheath to safely receive the tip of a used lancet, and a gripping handle portion extending between the two sheaths.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claim 1 over Coe

• Prior Art Relied Upon: Coe (Patent 5,207,699).
• Core Argument:
  • Prior Art Mapping: Petitioner argued that Coe anticipates every limitation of claim 1. Coe discloses a protective cap with a "releasing cavity" that serves as the claimed primary sheath for an unused lancet tip and a "non-releasing cavity" that serves as the claimed secondary sheath for a used lancet tip. A "handle portion" extends between these two cavities, meeting the final structural limitation of the claim. Petitioner asserted that after the cap is twisted off the lancet, the primary and secondary sheaths remain attached to the handle portion as claimed.

Ground 2: Claims 1, 4, and 9-15 are obvious over Coe in view of Sakata

• Prior Art Relied Upon: Coe (Patent 5,207,699) and Sakata (JP Patent App. No. 2005-168634A).
• Core Argument:
  • Prior Art Mapping: Coe was asserted to teach the fundamental structure of a protective cap with primary and secondary sheaths separated by a gripping handle. Sakata was introduced to teach the additional limitations of dependent claims 4, 9, and 15, specifically a "gripping handle portion compris[ing] at least one open loop." Sakata discloses an "operating portion" with a gap that forms an open loop structure. Sakata also addresses dimensional relationships between the gripping handle and lancet body relevant to claims 11-14.
  • Motivation to Combine: Petitioner argued a POSITA would combine Coe and Sakata to solve known problems in the art. Sakata expressly teaches that its design prevents damage to the fine tip of the lancet when the cap is twisted off—a known issue with designs like Coe's. Further, Sakata's design provides a tamper-evident feature, as its deformation upon removal prevents reattachment, alerting a user if a lancet has been previously used.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success in modifying Coe's cap with Sakata's features, as it involved the straightforward combination of known mechanical elements to achieve predictable benefits in safety and usability.

Ground 3: Claims 1, 4, and 9-15 are obvious over Sakata in view of Morita

• Prior Art Relied Upon: Sakata (JP Patent App. No. 2005-168634A) and Morita (Japanese Application Publication No. 19930285127).

• Core Argument:

  • Prior Art Mapping: Sakata was presented as the primary reference, disclosing a protective cap with a primary sheath, a gripping handle with an open loop, and a basic secondary sheath (a hollow cylindrical portion). Morita was asserted to teach an improved secondary sheath in the form of a "platform portion" specifically designed for safely disposing of a used lancet by fitting the needle tip into it. The combination of Sakata's main body with Morita's disposal platform was alleged to render all challenged claims obvious.
  • Motivation to Combine: The primary motivation was to improve the safe disposal of used lancets. Petitioner contended that a POSITA, starting with Sakata's design, would have looked to other solutions like Morita's to address the well-understood health and safety risks (e.g., viral infection from needlesticks) associated with handling used lancets.
  • Expectation of Success: Combining Morita's disposal platform with Sakata's cap would have been a predictable modification. Both references are in the same field, address analogous problems, and the integration would involve known design principles for plastic-molded medical components.

• Additional Grounds: Petitioner asserted an additional obviousness challenge for claims 4, 9-10, and 15 over Coe in view of Starnes (Application # 2007/0162064) and the One Touch Booklet, which relied on combining Coe's base design with Starnes's open-loop, tamper-evident features and the One Touch Booklet's teaching of placing branding on a flat surface of the cap.

4. Key Technical Contentions (Beyond Claim Construction)

• Petitioner argued that the term "embedment" in claim 1[a] ("initial embedment of a sharp lancing tip") does not require a specific manufacturing process. In the context of the anticipation argument against Coe, Petitioner contended that a POSITA would understand Coe's disclosure of a cap that is "integrally molded" to the lancet to necessarily mean the lancet tip is embedded within the cap material prior to use, even if Coe does not use the word "embedment."

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial would be inappropriate.
  • Under §325(d): The petition relied on prior art references (Coe, Sakata, Morita, Starnes) that were not considered during the original prosecution of the ’635 patent. Therefore, the arguments were not redundant or previously considered by the USPTO.
  • Under §314(a) / Fintiv: In light of a parallel district court litigation, Petitioner filed a stipulation agreeing not to pursue in that litigation the same grounds raised in the IPR petition, or any grounds that could have reasonably been raised. Petitioner asserted this stipulation negates concerns over duplicative efforts and weighs strongly against a discretionary denial.

6. Relief Requested

• Petitioner requested the institution of an inter partes review and the cancellation of claims 1, 4, and 9-15 of the ’635 patent as unpatentable.