Curio Bioscience Inc v. Prognosys Biosciences Inc

Prosecution History analysis

Examiner Search analysis

Invalidity Framework analysis

Petition

Petition Analysis

- Case Number: [IPR2025-00192](https://ai-lab.exparte.com/case/ptab/IPR2025-00192)
- Patent #: 11,549,138
- Filed: November 15, 2024
- Petitioner(s): [Curio Bioscience](https://ai-lab.exparte.com/party/curio-bioscience-inc), Inc.
- Patent Owner(s): Prognosys Biosciences Inc. and [10x Genomics](https://ai-lab.exparte.com/party/10x-genomics-inc), Inc.
- Challenged Claims: 1, 5, 17, 20, 23, 28-29

- Title: Spatially Encoded Biological Assays
- Brief Description: The ’138 patent relates to compositions for spatially resolved nucleic acid analysis. The technology involves an array of capture probes immobilized on a substrate, which are used to capture and identify nucleic acids from a biological sample, such as a tissue section, placed on the array.

#### Ground 1: Obviousness over Cantor - Claims 1, 5, 17, 20, 23, 28-29 are obvious over Cantor in view of the knowledge of a POSA.
  - **Prior Art Relied Upon:** Cantor (WO 2009/091934).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner argued that Cantor disclosed bead arrays with all structural elements of the claimed capture probes: a target-binding 'probe sequence', a 'primer sequence', and a unique 'identifier sequence' (barcode). Petitioner contended that because each bead in Cantor's array necessarily occupies a unique physical location, its unique barcode inherently identifies that location. The final limitation of immobilizing probes in a "random pattern" was argued to be an obvious design choice, as a person of ordinary skill in the art (POSA) would have known that randomly distributing barcoded beads and decoding their locations later was a known, simpler alternative to the difficult task of selectively placing them in a defined pattern, especially for high-density arrays.
    - **Motivation to Combine (for §103 grounds):** A POSA would combine Cantor's teachings with the known technique of random bead loading to simplify and expedite the fabrication of large-scale arrays. This avoids the technical challenges associated with precisely positioning millions of unique beads.
    - **Expectation of Success (for §103 grounds):** A POSA would have had a high expectation of success, as methods for decoding the locations of randomly distributed, barcoded beads were well-established in the art prior to the patent's priority date.

#### Ground 2: Obviousness over Cantor and Armani - Claims 1, 5, 17, 20, 23, 28-29 are obvious over Cantor in view of Armani.
  - **Prior Art Relied Upon:** Cantor (WO 2009/091934), Armani ("2D-PCR: a method of mapping DNA in tissue sections," *Lab on a Chip*, 2009).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** This ground built on Ground 1 to address claim 17, which adds the limitation of a "tissue section... disposed on the array." Petitioner asserted that while Cantor disclosed using its arrays with tissue samples, Armani explicitly taught a method of pressing a tissue section directly onto a multi-well array to perform spatial analysis of nucleic acids. Combining Cantor’s barcoded bead array with Armani’s direct tissue-on-array method would result in the composition of claim 17.
    - **Motivation to Combine (for §103 grounds):** A POSA would be motivated to combine the references to improve upon Armani's method. Using Cantor's sequencing-based detection with barcodes would allow for the analysis of low-abundance mRNAs (which Armani's fluorescence method could not reliably detect) and would greatly simplify the downstream workflow by allowing for pooled, multiplexed sequencing.
    - **Expectation of Success (for §103 grounds):** Success was reasonably expected because the combination involved applying an established sample preparation technique (Armani) to a known analysis platform (Cantor) to achieve predictable benefits in sensitivity and throughput.

#### Ground 3: Anticipation by Frisen - Claims 1, 5, 17, 20, 23, 28-29 are anticipated by Frisen.
  - **Prior Art Relied Upon:** [Frisen](https://ai-lab.exparte.com/case/ptab/IPR2025-00192/doc/1045) (WO 2014/060483).
  - **Core Argument for this Ground:**
    - **Prior Art Mapping:** Petitioner first argued that the ’138 patent is not entitled to a priority date earlier than February 14, 2019, due to a lack of written description support in its earlier priority applications for key claim elements, such as the "random pattern" of probes. This alleged break in the priority chain makes [Frisen](https://ai-lab.exparte.com/case/ptab/IPR2025-00192/doc/1045) (published 2014) anticipatory prior art. Petitioner contended [Frisen](https://ai-lab.exparte.com/case/ptab/IPR2025-00192/doc/1045) disclosed every element of the challenged claims, including an array on a substrate (e.g., a slide) with immobilized capture probes comprising a 'capture domain' (target-binding), a 'positional domain' (unique barcode), and an 'amplification domain' (primer binding site). [Frisen](https://ai-lab.exparte.com/case/ptab/IPR2025-00192/doc/1045) also explicitly taught applying thin tissue sections to the array and noted that probes could be immobilized on beads, which a POSA would know could be arranged randomly.
    - **Key Aspects:** The central thrust of this ground was the challenge to the ’138 patent's priority claim, which, if successful, makes the reference [Frisen](https://ai-lab.exparte.com/case/ptab/IPR2025-00192/doc/1045) anticipatory.

- Petitioner noted a dispute in co-pending litigation over the term "target-binding domain." The Patent Owner asserted this term covers the interaction of poly-T probes with poly-A tails on mRNA. While Petitioner disputed this construction, it argued the Board need not resolve the dispute because the cited prior art discloses both gene-specific probes and poly-T probes that would satisfy the Patent Owner's broader interpretation.

- Petitioner's primary technical contention, which underpinned its written description challenge, was a fundamental disconnect between the ’138 patent’s specification and its claims. The specification allegedly describes an invention focused on novel fluid delivery systems (e.g., inkjet printing) to apply reagents *onto* a tissue sample already affixed to a slide. In contrast, the challenged claims cover a pre-fabricated array of capture probes onto which a tissue sample is later placed, a different methodology Petitioner argued was not described or possessed by the inventor at the time of the priority applications.

- Petitioner argued against discretionary denial under §314(a) based on *Fintiv* factors, asserting the parallel litigation was in its early stages with limited investment by the court and parties, a stay would be appropriate, and the petition's merits were compelling. Regarding §325(d), Petitioner contended denial was unwarranted because the Examiner did not substantively evaluate the key prior art. The reference to Cantor was one of over 1,300 cited in an IDS and was never applied in a rejection, while the critical priority claim issues that make [Frisen](https://ai-lab.exparte.com/case/ptab/IPR2025-00192/doc/1045) anticipatory prior art were never considered during prosecution.

- Petitioner requested institution of an inter partes review and cancellation of claims 1, 5, 17, 20, 23, 28, and 29 of Patent [11,549,138](https://ai-lab.exparte.com/patent/11549138) as unpatentable.

10x Genomics' spatial genomics patent faces anticipation & obviousness. Frisen cited as anticipatory after a priority date challenge against 7 claims.