PTAB

IPR2026-00097

Magnolia Medical Technologies Inc v. Kurin Inc

Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Blood Sample Optimization Device
  • Brief Description: The ’052 patent discloses systems and methods for reducing blood culture contamination. The technology centers on a blood sequestration device that uses a chamber to collect an initial, potentially contaminated portion of a blood sample, and a separate sampling channel that bypasses the chamber to convey a subsequent, uncontaminated portion of the sample to a collection container.

3. Grounds for Unpatentability

Ground 1: Claims 1-24 are Anticipated under 35 U.S.C. §102 and/or Obvious under 35 U.S.C. §103 over Bullington800

  • Prior Art Relied Upon: Bullington800 (WO 2014/085800).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Bullington800, which was not considered during prosecution, discloses all elements of challenged claims 1-24. Bullington800 describes a blood collection device with an inlet port (distal port 505), an outlet port (proximal port 515), a sequestration chamber (fluid reservoir 580), and a sampling channel (second channel 507) that bypasses the chamber. A drawing force from a syringe at the outlet port draws an initial blood sample into the chamber. Critically, Petitioner asserted that Bullington800's housing (501) explicitly defines the inlet port, outlet port, and sampling channel, directly teaching the limitation the Examiner found missing in the prior art of record.
    • Motivation to Combine (for §103 ground): To the extent any element was not explicitly disclosed, Petitioner argued it would have been obvious. Specifically, a person of ordinary skill in the art (POSITA) would have understood that the housing (501) inherently defines the boundaries of the ports and channels it contains, making the "housing that defines" limitation obvious.
    • Expectation of Success (for §103 ground): A POSITA would have expected success in implementing the claimed features, as they represented standard mechanical design choices for fluid transfer devices.

Ground 2: Claims 1-24 are Obvious over Bullington800 in view of Brancazio

  • Prior Art Relied Upon: Bullington800 (WO 2014/085800) and Brancazio (Application # 2014/0336536).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground addresses any perceived deficiency in Bullington800 concerning the claimed "blood impermeable membrane" or the mechanism for applying the drawing force. Brancazio teaches using a vacuum to apply negative pressure through a gas-permeable but blood-impermeable membrane to draw blood into a collection chamber. Petitioner argued that modifying Bullington800's movable member (537) to be a gas-permeable, blood-impermeable membrane as taught by Brancazio would satisfy the claim limitations.
    • Motivation to Combine: A POSITA would combine these references to improve the functionality of the Bullington800 device. Incorporating Brancazio’s membrane would allow air within the sequestration chamber to be drawn out through the membrane, preventing air compression and facilitating a more efficient and complete collection of the initial blood sample. This combination would yield the predictable result of an improved blood draw mechanism.
    • Expectation of Success: A POSITA would have reasonably expected success in substituting Brancazio's known membrane material into the Bullington800 device, as it involved combining known elements for their intended purposes to achieve a predictable improvement in fluid dynamics.

Ground 3: Claims 13-24 are Obvious over Bullington800 in view of Brancazio and Liu

  • Prior Art Relied Upon: Bullington800 (WO 2014/085800), Brancazio (Application # 2014/0336536), and Liu (Application # 2012/0245042).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground specifically targets the "flexible material" limitation recited in independent claim 13. To the extent the combination of Bullington800 and Brancazio was deemed not to teach that the impermeable membrane is made of a flexible material, Petitioner argued that Liu supplied this teaching. Liu explicitly discloses using a "flexible gas-permeable hydrophobic membrane" made of materials like polytetrafluoroethylene (PTFE) to seal a fluid channel.
    • Motivation to Combine: A POSITA, seeking to implement the combined Bullington800-Brancazio device, would be motivated to use a flexible material for the membrane, as taught by Liu, for two primary reasons. First, flexibility is a known characteristic of materials used for such membranes. Second, a flexible material would ensure an improved seal between the membrane and the surrounding housing, a recognized benefit in fluidic systems.
    • Expectation of Success: The combination represents a simple substitution of a known material (Liu's flexible membrane) into the already-combined device of Bullington800 and Brancazio. A POSITA would have expected this routine design choice to work for its intended purpose with predictable results.

4. Key Claim Construction Positions

  • "a housing that defines": Petitioner noted that the parties in a corresponding district court litigation stipulated this term means "a casing that fixes or marks the limits of." This construction is critical because the Examiner's allowance was based on finding this feature absent from the prior art, a conclusion Petitioner argued Bullington800 refutes.
  • "flexible material": The parties also stipulated this term means "a material that can be flexed, bent, stretched, expanded, or compressed without breaking under normal conditions." This construction is central to the obviousness argument for claim 13 and its dependents, which relies on Liu's disclosure of flexible membrane materials.

5. Arguments Regarding Discretionary Denial

  • Petitioner stipulated that if the PTAB institutes this inter partes review (IPR), Petitioner will not raise in the parallel district court litigation any invalidity grounds that were raised or reasonably could have been raised in this petition. This stipulation was made to address potential discretionary denial under §314(a) and the Fintiv factors by mitigating concerns of parallel proceedings and inefficient use of resources.

6. Relief Requested

  • Petitioner requested institution of an IPR and cancellation of claims 1-24 of the ’052 patent as unpatentable.