PTAB

IPR2026-00150

Sarepta Therapeutics Inc v. Genzyme Corp

Log In
Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Analytical Ultracentrifugation for Characterization of Recombinant Viral Particles
  • Brief Description: The ’894 discloses methods for characterizing and quantifying different species of recombinant adeno-associated viral (rAAV) particles within a heterogeneous mixture using analytical ultracentrifugation (AUC). The methods are particularly directed to resolving and analyzing viral particles containing full, empty, and fragmented genomes.

3. Grounds for Unpatentability

Ground 1: Obviousness over Le Bec, de la Maza, and Sommer - Claims 1-7, 10-11, and 20-30 are obvious over Le Bec in view of de la Maza and Sommer.

  • Prior Art Relied Upon: Le Bec (WO 2014/125101), de la Maza (a 1978 book chapter), and Sommer (a 2003 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of references taught every limitation of the challenged claims. Le Bec taught using sedimentation velocity AUC (SV-AUC) to separate and quantify species in rAAV preparations, including empty, full, and intermediate particles, at rotor speeds within the claimed ranges (e.g., 16,000 rpm). The core of the Petition centered on de la Maza, which was not considered during prosecution. Petitioner asserted that de la Maza explicitly disclosed the key concept that Patent Owner relied upon for allowance: a "direct linear relationship" between AAV particle density (and thus sedimentation coefficient) and the length of the encapsidated DNA. This teaching, according to Petitioner, allows a person of ordinary skill in the art (POSA) to determine the genome size of unknown fragmented rAAV particles by comparing their sedimentation coefficients to those of particles with known genome sizes (e.g., empty or full particles). Finally, Sommer taught standard, well-known mathematical formulas for calculating the extinction coefficient of an rAAV particle based on its DNA molecular weight, which would allow a POSA to then determine the molar concentration and quantity of each species resolved by the AUC.
    • Motivation to Combine: Petitioner contended a POSA would combine these references because they all address the same technical problem: the characterization of rAAV preparations. A POSA using Le Bec's SV-AUC method to analyze rAAVs would have been motivated to consult foundational literature like de la Maza to understand the physical principles governing the separation and to interpret data for particles with fragmented genomes. Le Bec itself cited related work from the same research group as de la Maza, providing a direct link. Furthermore, a POSA seeking to quantify the separated species would naturally turn to a known method like that in Sommer to calculate concentrations based on the size information derived from the Le Bec and de la Maza combination.
    • Expectation of Success: Petitioner argued a POSA would have had a high expectation of success. The combination involved applying known principles (de la Maza's linear relationship) to a known technique (Le Bec's SV-AUC) and using standard calculations (Sommer's formulas) to achieve the predictable result of characterizing and quantifying rAAV species.

Ground 2: Obviousness over Le Bec, de la Maza, Sommer, and Cole - Claims 12-19 are obvious over the combination of Le Bec, de la Maza, and Sommer, further in view of Cole.

  • Prior Art Relied Upon: Le Bec (WO 2014/125101), de la Maza (a 1978 book chapter), Sommer (a 2003 journal article), and Cole (a 2008 book chapter).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground incorporated all arguments from Ground 1 and added Cole to address limitations in dependent claims 12-19 relating to specific AUC operating parameters. Petitioner argued that Cole, a general overview of AUC techniques, provided routine and conventional guidance for setting up SV-AUC experiments. Specifically, Cole taught running experiments for sufficient time (e.g., "at least 2 h") to ensure proper data acquisition, which meets the claimed run time of "about 0.5 hours to about 2 hours" (claims 12-15). Cole also explicitly taught using standard "two-channel cells with sector-shaped compartments" and "double-sector centerpieces" in dialysis equilibrium, and running experiments until the lightest components clear the optical window, directly teaching the limitations of claims 16-19.
    • Motivation to Combine: The motivation to add Cole was based on its nature as a standard guide for implementing the primary methods taught by the other references. Petitioner argued that a POSA, when setting up the SV-AUC experiment described in Le Bec, would have been motivated to consult a standard reference like Cole for guidance on optimizing routine parameters such as run time and equipment setup. The ’894 patent itself acknowledged that optimizing AUC parameters was within the purview of a skilled artisan.
    • Expectation of Success: Success was expected because Cole merely provided instructions for the routine optimization and setup of a well-established analytical technique (SV-AUC) as applied in Le Bec.

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-7 and 10-30 of the ’894 patent as unpatentable.