Bico Group Ab v. OrgaNovo Inc

1. Case Identification

• Case #: IPR2021-01543
• Patent #: 9,315,043
• Filed: September 20, 2021
• Petitioner(s): BICO Group AB
• Patent Owner(s): Organovo, Inc.
• Challenged Claims: 1-12

2. Patent Overview

• Title: Automated devices, systems, and methods for the fabrication of tissue
• Brief Description: The ’043 patent relates to a "bioprinter" using a multiaxial nozzle for the automated fabrication of tissue constructs. The system is configured to deposit "bio-ink," which comprises living cells, through concentric outputs to form layered, tubular structures such as a core layer and a mantle layer.

3. Grounds for Unpatentability

Ground 1: Obviousness over Yu - Claims 1-12 are obvious over Yu.

• Prior Art Relied Upon: Yu ("Evaluation of Cell Viability and Functionality in Vessel-like Bioprintable Cell-Laden Tubular Channels," J Biomech Eng. 135(9) (2013)).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Yu, a journal article on bioprinting, discloses a robotic bioprinting platform with all key features of independent claim 1. Yu’s system includes a coaxial nozzle with a "sheath section" and a "core section" (N-value of two) for concentric flow, independent inputs for different materials (cell-laden biomaterial and a crosslinker), and independent outputs to form 3D tubular constructs. Petitioner contended Yu teaches a bio-ink with living cells (cells suspended in an alginate solution) and a support material (a calcium chloride crosslinker solution). For dependent claims, Petitioner asserted Yu discloses distinct means for independent flow regulation (a pressure regulator for the sheath and a syringe pump for the core) and explicitly suggests a future implementation using a "concentric triaxial nozzle assembly" (N-value of three).
  • Motivation to Combine: The challenge was framed under 35 U.S.C. §103, asserting that to the extent Yu’s crosslinker was not considered a sufficient "support material," a person of ordinary skill in the art (POSITA) would find it obvious to use other well-known support materials. The motivation was to provide structural integrity to the printed construct, a known and predictable goal in the field.
  • Expectation of Success: A POSITA would have had a high expectation of success because Yu's system was specifically designed for and successfully used to fabricate cell-laden tubular channels, the primary purpose of the claimed invention.

Ground 2: Obviousness over Mullens - Claims 1-3 and 10-12 are obvious over Mullens.

• Prior Art Relied Upon: Mullens (Application # 2011/0064784).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that Mullens discloses a method for producing 3D filament constructs using a co-extrusion nozzle. This nozzle features separated "inner parts" and "outer parts" for depositing different material compositions, thereby forming filaments with an internal zone and an outer sheath. This structure was argued to directly map to the claimed coaxial nozzle with concentric flow. Mullens was cited as expressly teaching that the deposited materials may comprise living cells, such as stem cells and osteoblast cells, fulfilling the "bio-ink" limitation. The system’s use of separate syringes and an "air pressure plunger" for controlled deposition was argued to meet the "means to independently regulate" limitation of claim 2.
  • Motivation to Combine: Petitioner argued that even though Mullens describes the use of cells in a "preferred embodiment" that is textually separate from the primary description of the nozzle, a POSITA would find it obvious to combine these teachings. All disclosures in Mullens are directed to the common goal of creating structured 3D biological constructs, making the use of its cell-containing compositions with its co-extrusion nozzle a simple and logical combination.
  • Expectation of Success: Success would be expected because Mullens is directed to the controlled, layered deposition of multi-component filaments. Incorporating living cells into such extruded structures was a well-known and desired application in the art at the time.

4. Key Claim Construction Positions

• "an N-value of [two/three] or more": Petitioner proposed this term should be construed as "one or more coaxial nozzles with capability for [two/three] or more concentric flows." This construction was based on the specification's description of "multiaxial nozzles" and was crucial for mapping the "sheath" and "core" sections of the prior art to the "N-value of two" limitation.
• "means to independently regulate the flow...": Petitioner identified this as a means-plus-function term under 35 U.S.C. §112, ¶6. The stated function is "to independently regulate the flow of each of the at least two different materials," with the corresponding structures disclosed in the specification being "positive displacement, pneumatic displacement, hydraulic displacement, acoustic resonance, or a combination thereof" and their statutory equivalents. This allowed Petitioner to map the syringe pumps and pressure regulators of the prior art to this limitation.

5. Arguments Regarding Discretionary Denial

• §314(a) (Fintiv): Petitioner argued that discretionary denial under Fintiv was inappropriate. They contended the Board should prioritize the first-filed declaratory judgment suit in Delaware over a later-filed infringement suit in Texas. Factors weighing against denial included that the district court proceedings were in their earliest stages, with no trial date set, no substantive orders issued, and no discovery conducted. Petitioner also stated its intent to file a motion to stay the litigation pending the outcome of the inter partes review (IPR).
• §325(d) (Advanced Bionics): Petitioner asserted that denial under §325(d) was also unwarranted. Regarding Ground 1, the primary reference (Yu) was never presented to or considered by the Examiner during prosecution and was not cumulative of the cited art. For Ground 2, although Mullens was considered during prosecution, Petitioner argued the Examiner committed a material error by accepting the Applicant's misrepresentation that Mullens was "completely silent" on the use of living cells, when Mullens expressly discloses them.

6. Relief Requested

• Petitioner requests institution of IPR and cancellation of claims 1-12 of Patent 9,315,043 as unpatentable.