Bico Group AB v. MUSC Foundation for Research Development

1. Case Identification

• Case #: IPR2021-01544
• Patent #: 9,752,116
• Filed: September 21, 2021
• Petitioner(s): BICO Group AB
• Patent Owner(s): MUSC Foundation for Research Development
• Challenged Claims: 1-5

2. Patent Overview

• Title: Self-assembling cell aggregates and methods of making engineered tissue using the same.
• Brief Description: The ’116 patent discloses a method for producing a three-dimensional tissue construct by depositing pre-formed “cell aggregates” from a dispensing device and subsequently allowing the aggregates to fuse together to form tissue.

3. Grounds for Unpatentability

Ground 1: Claims 1-5 are disclosed by Boland

• Prior Art Relied Upon: Boland (Patent 7,051,654).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Boland anticipated all challenged claims by disclosing a method for creating tissue constructs using an ink-jet printer. This printer acts as the claimed "dispensing device" to deposit "cell aggregates" onto a substrate. Critically, Boland taught that these deposited aggregates are "allowed to fuse into a cohesive cellular assembly," directly mapping to the core limitations of independent claim 1. Petitioner further asserted that Boland explicitly disclosed the dependent claim features, including dispensing in various patterns (claim 2), using aggregates made of a single cell type (homocellular, claim 3), using aggregates of multiple cell types (heterocellular, claim 4), and operating the printer via a computer-based "control system" (claim 5).

Ground 2: Claims 1-5 are disclosed by Cell Printing 2

• Prior Art Relied Upon: Cell Printing 2 (Boland et al., “Cell and Organ Printing 2: Fusion of Cell Aggregates in Three-Dimensional Gels,” The Anatomical Record (2003)).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that Cell Printing 2, a journal article by the same inventor as the Boland patent, also anticipated all challenged claims. The article described a "cell printer" for "organ printing" that places "cell aggregates" on a gel substrate "close enough for fusion to occur," thereby forming "tissue constructs." This teaching was argued to meet every limitation of independent claim 1. The article also disclosed computer-controlled placement of cells for creating complex 3D organs (meeting claim 5), depositing materials in patterns like a "ring pattern" (claim 2), and using both single cell types like Bovine aortal endothelial cells (homocellular, claim 3) and placing "different cell types" (heterocellular, claim 4).

Ground 3: Claims 1-5 are obvious over Warren in view of Frondoza

• Prior Art Relied Upon: Warren (Patent 6,986,739) and Frondoza (Application # 2001/0014475).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Warren disclosed a "human architecture tool" (HAT), a direct-write deposition system for printing various biological materials, including cells, to fabricate 3D engineered tissue constructs. This system met the limitations of a "dispensing device" used to produce a "tissue construct." While Warren focused on depositing individual cells, Frondoza taught the creation and use of "aggregated cells" that are implanted (e.g., via syringe) and subsequently bind together. Petitioner asserted that combining Frondoza’s teaching of using pre-formed, fusible cell aggregates with Warren’s deposition system rendered the claims obvious.
  • Motivation to Combine: A POSITA would combine Frondoza's teaching of using cell aggregates with Warren's HAT system to more efficiently build tissue constructs. Petitioner argued that printing larger, pre-formed aggregates is a faster process that increases throughput and reduces the time required for careful environmental control to maintain cell viability compared to printing individual cells.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success. Warren already disclosed using syringe-based dispensers for depositing cells, and Frondoza explicitly taught placing cell aggregates into a syringe for dispensing. Therefore, integrating Frondoza’s known cell aggregates into Warren's known dispensing system would have been a predictable and straightforward modification.

• Additional Grounds: Petitioner asserted alternative obviousness challenges, including that claims 1-5 are obvious over Boland alone (Ground 2) and that claim 4 is obvious over Cell Printing 2 alone (Ground 4), relying on the same disclosures but arguing it would have been obvious to combine different embodiments within those single references.

4. Key Claim Construction Positions

• "cell aggregates": Petitioner proposed this term be construed as "groups of two or more cells." This construction was based on the specification's description that each aggregate comprises a "plurality of living cells" and that they need not be uniform in size or shape.
• "homocellular": Based on the specification, Petitioner proposed this term be construed to mean "comprise a plurality of living cells of a single cell type."
• "heterocellular": Correspondingly, Petitioner proposed this term be construed to mean "comprise a plurality of living cells of at least two cell types."

5. Arguments Regarding Discretionary Denial

• Petitioner argued against discretionary denial under 35 U.S.C. §314(a) based on Fintiv factors. It contended that its declaratory judgment action against the Patent Owner was filed first and should take precedence over the Patent Owner's later-filed infringement suit under the "first-to-file" rule. Petitioner also noted the co-pending litigation was in its earliest stages, with no trial date set and no substantive overlap on the validity issues presented in the petition.
• Petitioner also argued that denial under 35 U.S.C. §325(d) would be inappropriate. It asserted that the grounds were not the same or substantially the same as those raised during prosecution because the key references were either never cited (Frondoza) or were merely listed in an Information Disclosure Statement without any substantive discussion or application by the Examiner (Boland, Cell Printing 2, and Warren).

6. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-5 of the ’116 patent as unpatentable.