Prior art

Due to the limitations of the provided "Full patent text" (which is an excerpt from Google Patents) and the inability to directly retrieve a complete "References Cited" list from a live database search within this environment, a comprehensive list of all patent citations for US12013326B2 cannot be generated. The provided patent text does not contain a dedicated "References Cited" section listing patent numbers. Furthermore, the claims of US12013326B2 were not present in the provided text and could not be directly retrieved via search snippets.

However, the provided patent text explicitly references non-patent literature (NPL) in its descriptive sections, highlighting their relevance as prior art or in defining the need for the invention. Based on the patent's own discussion, the following non-patent literature references are identified as highly relevant prior art:

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Most Relevant Prior Art (Non-Patent Literature)

1. Berkowitz, S.A. & Philo, J.S., (2007) Anal. Biochem., 362:16-37

• Full Citation: Berkowitz, S. A., & Philo, J. S. (2007). Use of analytical ultracentrifugation to characterize adenovirus preparations. Analytical Biochemistry, 362(1), 16-37.
• Publication Date: March 15, 2007
• Brief Description: This publication details the use of analytical ultracentrifugation (AUC) for characterizing adenovirus preparations. The patent text itself states: "Use of analytical ultracentrifugation to characterize adenovirus preparations is provided by Berkowitz, S A & Philo J S, (2007) Anal. Biochem., 362:16-37."
• Potential Anticipation (35 U.S.C. § 102): This reference potentially anticipates the broader concept of using analytical ultracentrifugation for characterizing viral particles, specifically adenovirus. The invention of US12013326B2 broadly claims methods of characterizing recombinant viral particles using AUC, including steps like monitoring sedimentation, plotting differential sedimentation coefficient distribution (C(s)) versus sedimentation coefficient (S), and integrating peaks to determine relative concentration. The Berkowitz paper demonstrates AUC application for adenovirus, which falls under "recombinant viral particles" as defined by US12013326B2. While US12013326B2 claims extend to various recombinant viral particles (e.g., AAV, lentivirus, HSV) and specific parameters/applications (like assessing genome integrity, identifying empty capsids or variants, and monitoring purification processes), the fundamental application of AUC to characterize a viral preparation, specifically adenovirus, could be considered anticipated by Berkowitz. Without the full claims, a direct element-by-element comparison is challenging, but the core methodological application of AUC to analyze adenovirus preparations is disclosed.

2. Steinbach, S et al., (1997) J. Gen. Virol., 78:1453-1462

• Full Citation: Steinbach, S., et al. (1997). Production of recombinant adeno-associated virus (rAAV) serotypes: development of an immunoassay for rAAV serotypes. Journal of General Virology, 78(Pt 6), 1453-1462.
• Publication Date: June 1997 (publication year 1997).
• Brief Description: This publication describes an immunoassay for characterizing recombinant adeno-associated viral (rAAV) serotypes. The present patent explicitly differentiates itself from this prior art, stating: "Steinbach, S et al., (1997) J. Gen. Virol., 78:1453-1462 provides an immunoassay for rAAV serotypes. What is needed is a generic assay to characterize recombinant viral preparations regardless of the nucleic acid sequence of the recombinant viral genome or the serotype of the capsid."
• Potential Anticipation (35 U.S.C. § 102): The Steinbach reference describes a method for characterizing rAAV, but it relies on an immunoassay. The present invention (US12013326B2) seeks to provide a generic assay, independent of nucleic acid sequence or capsid serotype, using analytical ultracentrifugation. Therefore, while Steinbach characterizes rAAV, its method (immunoassay) and its specificity (serotype-dependent) are distinct from the AUC-based, generic approach of US12013326B2. It does not anticipate the methodology of using analytical ultracentrifugation or the genericity of the characterization across different viral types or genome content. It serves as background art illustrating a problem (lack of a generic assay) that US12013326B2 aims to solve.