LifeScan Inc v. Facet Technologies LLC

1. Case Identification

• Case #: IPR2023-00712
• Patent #: 8,840,635
• Filed: March 20, 2023
• Petitioner(s): LifeScan, Inc.
• Patent Owner(s): Facet Technologies, LLC
• Challenged Claims: 1-3, 5-8, 14, and 16-18

2. Patent Overview

• Title: Protective Sterility Cap for a Lancet
• Brief Description: The ’635 patent discloses a protective sterility cap for a single-use lancet designed for improved handling and safety. The cap features a primary sheath for covering the unused lancet tip, a secondary sheath for receiving the used tip for disposal, and an intermediate gripping handle portion connecting the two sheaths.

3. Grounds for Unpatentability

Ground 1: Claims 1-3, 5-8, 14, and 16-18 are anticipated by Saikley under 35 U.S.C. §102.

• Prior Art Relied Upon: Saikley (Application # 2004/0138588).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Saikley’s “protective cap 78” discloses every limitation of the challenged claims. Specifically, the “twist-off joint” and an adjoining portion of the cap’s “handling tab” form the claimed primary sheath for initial embedment of the lancet tip. The “hollow cup or solid ‘pin cushion’ type area 82” at the opposite end of the cap constitutes the secondary sheath for receiving the used lancet tip. The large “handling tab” is the claimed gripping handle portion extending between the primary and secondary sheaths. Petitioner asserted that dependent claims relating to a flat display surface (claim 3), a solid body (claim 5), and specific dimensional ratios (claims 6-8) are also expressly or inherently disclosed by Saikley’s figures and description, which emphasize a large, flat, solid handling tab to aid users with dexterity issues.
  • Key Aspects: Petitioner contended that while Saikley does not use the specific term “embedment,” a person of ordinary skill in the art (POSITA) would understand from the disclosure of an “integrally molded pull-off tab” that the lancet tip is embedded within the cap prior to use, a common practice acknowledged in the ’635 patent itself.

Ground 2: Claims 1-3, 5-8, 14, and 16-18 are obvious over Saikley in view of Stout under §103.

• Prior Art Relied Upon: Saikley (Application # 2004/0138588) and Stout (Application # 2006/0241669).
• Core Argument for this Ground:
  • Prior Art Mapping: As an alternative to its anticipation argument, Petitioner argued that if Saikley is found not to disclose the “initial embedment” of the lancet tip, it would have been obvious to modify Saikley’s device using the teachings of Stout. Stout explicitly teaches a sterility cap that is “co-molded” with the lancet body, with the sharp tip “securely embedded therein.” Further, if Saikley is found not to explicitly disclose the dimensional limitations of claims 6-8 and 14-18, Stout’s teaching of a lancet with a lateral span “considerably greater” and “at least twice” its thickness would render these specific ratios an obvious design choice to improve handling.
  • Motivation to Combine: A POSITA would combine Saikley and Stout as both references are in the same field of endeavor (lancing devices), address the same problems of handling and alignment, and describe similar oversized caps to aid users. Stout’s system is also described as a “backwards-compatible attachment to an existing meter,” such as the FreeStyle meter disclosed in Saikley, providing a direct motivation for combination.
  • Expectation of Success: A POSITA would have a reasonable expectation of success, as combining the teachings would involve using conventional insert molding techniques (from Stout) to modify a known cap design (from Saikley) to achieve the predictable result of a sterile, securely held needle tip that is easier for users to handle.

Ground 3: Claims 1-3, 5-8, 14, and 16-18 are anticipated by Iio under §102.

• Prior Art Relied Upon: Iio (Application # 2005/0131441).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that the second embodiment in Iio, the “puncture needle cap 91,” anticipates all challenged claims. Iio’s “puncture needle separation groove 65a” functions as the primary sheath that covers and embeds the unused lancet tip. The “disposal slot 92” at the cap’s opposite end serves as the secondary sheath for receiving and safely enclosing the used lancet tip. The cylindrical body of the cap extending between this groove and the disposal slot constitutes the claimed gripping handle portion. Petitioner contended that the dimensional limitations of dependent claims 6-8 and 14-18 are inherently disclosed by Iio’s figures and textual descriptions, which show a gripping portion with a lateral span and length significantly greater than the lancet thickness to ensure “excellent usability and handleability.”

• Additional Grounds: Petitioner asserted additional obviousness challenges based on Saikley in view of the FreeStyle manual (for branding indicia), Iio in view of Peckham (for adding a textured grip to improve handling), and Iio in view of the FreeStyle manual (for branding).

4. Key Claim Construction Positions

• Petitioner adopted the district court's construction for "a secondary sheath for receiving the sharp lancing tip of a used lancet" as meaning "a secondary sheath for covering the sharp lancing tip of a used lancet by embedding or enclosing the lancet tip." Petitioner stated that for all other terms, the plain and ordinary meaning controls and no further constructions were necessary to resolve the unpatentability issues.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate because the primary references (Saikley and Iio) were not considered during prosecution. Petitioner asserted these references teach the very features—a secondary sheath and an intermediate handle portion—that the applicant successfully argued were missing from the prior art of record to secure allowance.
• Petitioner further argued denial under §314(a) based on Fintiv factors would be inappropriate, as Petitioner provided a stipulation that, if the IPR is instituted, it will not pursue in the parallel district court litigation the same grounds or any grounds that could have reasonably been raised in the IPR.

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-3, 5-8, 14, and 16-18 of the ’635 patent as unpatentable.