Gator Bio Inc v. Sartorius BioAnalyTical Instruments Inc

1. Case Identification

• Case #: IPR2025-00633
• Patent #: 8,647,588
• Filed: February 24, 2025
• Petitioner(s): Gator Bio, Inc.
• Patent Owner(s): Sartorius Bioanalytical Instruments, Inc.
• Challenged Claims: 1-19

2. Patent Overview

• Title: Apparatus for Packaging an Optical Sensing Assembly
• Brief Description: The ’588 patent relates to a "tip tray" apparatus for packaging optical sensor probes, specifically those used for biolayer interferometry (BLI/RIfS), to facilitate their use with standard laboratory equipment like microtiter plates and automated assay systems.

3. Grounds for Unpatentability

Ground 1: Obviousness over Miles and Yang - Claims 1-13 and 18-19 are obvious over Miles in view of Yang.

• Prior Art Relied Upon: Miles (Patent 4,087,248) and Yang (a 2003 printed publication from a SPIE conference).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Miles taught the foundational apparatus for packaging sensor probes for use in automated assays. Miles disclosed a tip tray (substrate) with an array of openings configured to hold individual sensor probes (coated pipette tips), with the tips suspended through the openings. This tray format was explicitly designed for use with 96-well microtiter plates. Petitioner asserted this combination met the structural limitations of claim 1 regarding the substrate, its plurality of openings, and the arrangement of probes therein. However, Miles's probes were general-purpose and not the specific BLI/RIfS probes claimed. Petitioner contended that Yang disclosed the missing element: a specific BLI/RIfS "optical bioprobe." Yang taught an optical sensing assembly comprising an optical fiber coated with a transparent interference layer. This layer had first and second reflecting surfaces separated by at least 50 nm and a distal surface coated with analyte-binding molecules (antibodies), thus teaching the specific probe limitations of the challenged claims.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Yang’s BLI/RIfS probe with Miles’s tip tray system to gain the known benefits of high-throughput, automated assays. By 2005, using 96-well microtiter plates was the de facto standard for laboratory assays. A POSA would have been motivated to adapt the newer BLI/RIfS probe technology (Yang) to this standard platform by packaging the probes in a compatible tip tray (Miles) to increase efficiency, reduce error, and leverage existing automated laboratory equipment.
  • Expectation of Success: A POSA would have had a high expectation of success because packaging various types of sensor probes in tip trays was a well-known and predictable technique. The functional purpose of Miles's probes and Yang's probes was similar (binding analytes on a tip), making the substitution of one for the other in Miles's packaging system a matter of routine adaptation.

Ground 2: Obviousness over Miles, Yang, and Rainin - Claims 2-8 and 13-19 are obvious over Miles in view of Yang and Rainin.

• Prior Art Relied Upon: Miles (Patent 4,087,248), Yang (2003 SPIE publication), and Rainin (Patent 4,676,377).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon Ground 1 by adding Rainin to address dependent claims reciting a protective enclosure. Petitioner argued that after combining Miles and Yang to create a tip tray of BLI/RIfS probes, a POSA would look to prior art for methods of storing and protecting them. Rainin taught a standard, commercially relevant solution: an enclosed, stackable storage box for pipette tip trays. Rainin disclosed a base and a cover that lock together around the tip tray to provide a "dust-free" enclosure, protecting the tips during storage and transport. Petitioner asserted this directly taught the limitations of claims 13, 15, and 18 relating to a cover and base forming an enclosure.
  • Motivation to Combine: A POSA would be motivated to incorporate Rainin’s storage box to protect the sensitive biological coatings on the BLI/RIfS probes from contamination and physical damage, a standard practice for pipette tips. This would ensure probe integrity and sterility, which is critical for reliable assay results. The motivation was simply to apply a well-known, conventional storage solution to the combined Miles/Yang apparatus.

Ground 3: Obviousness over Miles and WO854 - Claims 1-13 and 18-19 are obvious over Miles in view of WO854.

• Prior Art Relied Upon: Miles (Patent 4,087,248) and WO854 (WO 2005/047854).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground was presented as a substantial parallel to Ground 1, substituting WO854 for Yang as the source for the claimed BLI/RIfS probe technology. Petitioner argued that WO854, like Yang, disclosed a fiber-optic sensor probe for detecting analytes using BLI/RIfS. The probe described in WO854 comprised a first optical element with two reflecting surfaces separated by more than 50 nm, with the first surface coated with analyte-binding molecules. This probe was removably coupled to an optical fiber, teaching the specific probe limitations of the independent claims.
  • Motivation to Combine: The motivation was identical to that in Ground 1: a POSA would package the BLI/RIfS probes of WO854 in the standardized tip tray of Miles to enable high-throughput, automated assays compatible with the microtiter plate standard.
• Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 4) based on the combination of Miles, WO854, and Rainin, which parallels the logic of Ground 2 by adding Rainin's protective enclosure to the Miles/WO854 combination.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be inappropriate. The petition relied on prior art, particularly Miles, that was not before the examiner during prosecution. Petitioner asserted the examiner allowed the claims based on the mistaken belief that prior art did not teach BLI/RIfS probes with the claimed features, a belief contradicted by references like Yang and WO854 which, although cited in an IDS, were not substantively considered. The petition also presented new evidence and arguments, including expert testimony, that were not previously before the Office.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-19 of Patent 8,647,588 as unpatentable.