heru Inc v. UAB Research Foundation

1. Case Identification

• Case #: IPR2022-01148
• Patent #: 11,224,340
• Filed: June 21, 2022
• Petitioner(s): Heru, Inc.
• Patent Owner(s): THE UAB RESEARCH FOUNDATION
• Challenged Claims: 1-14 and 16-20

2. Patent Overview

• Title: Method and System for Dark Adaptometry
• Brief Description: The ’340 patent describes methods and systems for measuring an eye's ability to adapt to darkness. The technique involves first exposing the eye to a photobleaching light with a tailored, narrow wavelength spectrum to affect specific photoreceptors (rods or cones), and then measuring the eye's recovery of light sensitivity over time using a psychophysical test.

3. Grounds for Unpatentability

Ground 1: Claims 1-13 and 16-20 are anticipated by or obvious over Azevedo under 35 U.S.C. §§102/103.

• Prior Art Relied Upon: Azevedo (D. Azevedo, Automated Imaging Dark Adaptometry in Human Retina, UMI (August 1996)).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Azevedo, a 1996 doctoral dissertation, taught every limitation of the challenged claims. Azevedo disclosed a complete dark adaptometry system that performed the claimed method steps: (1) photobleaching an eye with a light having a "tailored wavelength spectra" by using filters to create specific ranges (e.g., 500-700 nm) that preferentially bleach rods and certain cone pigments; (2) exposing the retina to a stimulus light; (3) obtaining a series of patient responses over time indicating observation of the light; and (4) administering a dark adaptometry psychophysical test to determine the status of dark adaptation. Petitioner asserted Azevedo's disclosed broad wavelength ranges (e.g., 400-700 nm and 500-700 nm) anticipated the specific narrower ranges recited in dependent claims 2-13.
  • Motivation to Combine (for §103 grounds): As an alternative for the dependent claims, Petitioner argued it would have been obvious to select the specific, narrower wavelength ranges from Azevedo’s broader teachings. Azevedo taught that different photoreceptors have different peak absorption wavelengths and that certain diseases "selectively affect" rods or cones. A POSITA would therefore have been motivated to use a narrower band of light within Azevedo's disclosed spectrum to isolate and test specific photoreceptors, a predictable optimization of Azevedo's own system.
  • Expectation of Success: A POSITA would have had a high expectation of success, as using specific wavelengths to target photoreceptors was a known technique for isolating their function, which would predictably result in a more targeted dark adaptation measurement.

Ground 2: Claims 1-13 and 16-20 are obvious over Azevedo in view of Rice under §103.

• Prior Art Relied Upon: Azevedo (dissertation, 1996) and Rice (Patent 6,895,264).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground asserted that the combination of Azevedo and Rice rendered the claims obvious. Azevedo provided the foundational dark adaptometry method and system. Rice supplied the explicit teaching that it is preferable to use a bleaching light with "selected wavelengths" that match the active absorption range of the target visual pigments. Rice specifically disclosed a preferred range of 500 nm to 650 nm, which covers many of the claimed wavelength ranges.
  • Motivation to Combine: A POSITA would combine Rice’s teachings with Azevedo’s system to improve diagnostic specificity. Azevedo taught that various eye diseases selectively affect either rods or cones, creating a clear reason to want to isolate testing for those photoreceptors. Rice taught precisely how to achieve this isolation by using a photobleaching light with a wavelength range that preferentially targets certain pigments (e.g., cones). Applying Rice's preferred wavelength ranges to Azevedo's system was presented as a straightforward combination to achieve a known goal.
  • Expectation of Success: The combination was argued to be predictable, as applying a light known to stimulate cones (per Rice) to a system for measuring photoreceptor function (Azevedo) would be expected to yield a measurement of cone function.

Ground 3: Claims 1-14 and 16-20 are obvious over Jackson in view of Rice under §103.

• Prior Art Relied Upon: Jackson (International Publication No. WO 2005/023094) and Rice (Patent 6,895,264).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that Jackson taught all elements of the independent claims except for the use of a tailored wavelength photobleaching light. Jackson disclosed a complete method for measuring rod-mediated dark adaptation using a psychophysical test to diagnose diseases like AMD, but primarily described using a broad-spectrum "achromatic" bleaching light. Rice was argued to supply the missing element by teaching the preference for using a bleaching light with selected wavelengths (e.g., 500-650 nm) tailored to the absorption range of specific photoreceptors.
  • Motivation to Combine: A POSITA would combine Rice's tailored bleaching light with Jackson’s system to enhance its capabilities. Jackson explicitly stated a desire to "eliminate the contribution of the cone photoreceptors" when testing rod function and also suggested using dark adaptation to study diseases like diabetes (known to affect cones). Rice taught that using tailored wavelengths within its preferred 500-650 nm range could preferentially bleach cones, which was useful for diabetic patients. A POSITA would have incorporated Rice's targeted approach into Jackson's system to achieve the isolation Jackson desired and to expand its diagnostic utility as Jackson suggested.
  • Expectation of Success: Success was predictable because implementing a known method for selectively bleaching photoreceptors (from Rice) into a comprehensive dark adaptation testing system (from Jackson) would be expected to result in a system capable of selective photoreceptor testing.

4. Arguments Regarding Discretionary Denial

• §325(d) - Same or Substantially Same Art: Petitioner argued against discretionary denial under §325(d). It asserted that Azevedo is new prior art that was never before the Patent Office. For Jackson and Rice, which were cited in an Information Disclosure Statement, Petitioner argued the examiner committed a material error by failing to appreciate or address their specific, highly relevant teachings regarding the use of tailored wavelength bleaching lights to isolate photoreceptor function. The examiner never issued any rejection based on these references and allowed the claims after only a double-patenting rejection.
• §314(a) - Fintiv Factors: Petitioner argued that the Fintiv factors strongly favor institution. The parallel district court litigation was in its earliest stages, with a trial date nearly two years away and well after a Final Written Decision (FWD) would issue from the PTAB. Petitioner asserted it was diligent in filing the petition, and that the merits of the unpatentability grounds were particularly strong.

5. Relief Requested

• Petitioner requests the institution of an inter partes review and the cancellation of claims 1-14 and 16-20 of Patent 11,224,340 as unpatentable.