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Regents of University of California v. Broad Institute, Inc.

United States Court of Appeals, Federal Circuit

September 10, 2018

REGENTS OF THE UNIVERSITY OF CALIFORNIA, UNIVERSITY OF VIENNA, EMMANUELLE CHARPENTIER, Appellants
v.
BROAD INSTITUTE, INC., MASSACHUSETTS INSTITUTE OF TECHNOLOGY, PRESIDENT AND FELLOWS OF HARVARD COLLEGE, Appellees

          Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. 106, 048.

          Donald B. Verrilli, Jr., Munger, Tolles & Olson LLP, Washington, DC, argued for appellants. Appellants Regents of the University of California, University of Vienna also represented by Ginger Anders; Edward George Dane, Adam R. Lawton, Los Angeles, CA.

          Raymond N. Nimrod, Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY, argued for appellees. Also represented by Matthew D. Robson; Steven R. Trybus, Harry J. Roper, Jenner & Block LLP, Chicago, IL.

          Li-Hsien Rin-Laures, RinLaures LLC, Chicago, IL, for appellant Emmanuelle Charpentier. Also represented by Sandip Patel, Marshall, Gerstein & Borun LLP, Chicago, IL.

          Before Prost, Chief Judge, Schall and Moore, Circuit Judges.

          MOORE, CIRCUIT JUDGE.

         The University of California, the University of Vienna, and Emmanuelle Charpentier, (collectively "UC"), appeal a decision of the Patent Trial and Appeal Board determining there was no interference-in-fact between UC's Application No. 13/842, 859, and the claims of twelve patents and one application owned by the Broad Institute, Inc., Massachusetts Institute of Technology, and the President and Fellows of Harvard College, (collectively "Broad"). Because the Board's underlying factual findings are supported by substantial evidence and the Board did not err in concluding that Broad's claims would not have been obvious over UC's claims, we affirm.

         Background

         The involved claims relate to the use of a CRISPR-Cas9[1] system for the targeted cutting of DNA molecules. The system includes three components: (1) a "crRNA"; (2) a "tracrRNA"; and (3) the Cas9 protein. J.A. 4803. The crRNA is an RNA molecule with a variable portion that targets a particular DNA sequence. J.A. 4799-803. The nucleotides that make up the variable portion complement the target sequence in the DNA and hybridize with the target DNA. J.A. 4801. Another portion of the crRNA consists of nucleotides that complement and bind to a portion of the tracrRNA. J.A. 4801. The Cas9 protein interacts with the crRNA and tracrRNA and cuts both strands of DNA at the target location. J.A. 4799.

         In August 2012, UC researchers published an article ("Jinek 2012") demonstrating that the isolated elements of the CRISPR-Cas9 system could be used in vitro in a non-cellular experimental environment. J.A. 4799-804. In February 2013, Broad researchers published an article describing the use of CRISPR-Cas9 in a human cell line. J.A. 4682-86. Both parties sought patent protection. CRISPR-Cas systems occur naturally in prokaryotes such as bacteria, J.A. 4799, but have not been found to naturally exist in eukaryotes, such as plants and animals, J.A. 5488; see also J.A. 5006, 5029. It is undisputed that the Jinek 2012 article did not report the results of experiments using CRISPR-Cas9 in a eukaryotic cell, and the claims in UC's '859 application do not refer to a particular cell type or environment. J.A. 13, 9665-66. Claim 165 of the '859 application is representative:

165. A method of cleaving a nucleic acid comprising
contacting a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)- CRISPR associated (Cas) (CRISPR-Cas) system comprising
a) a Cas9 protein; and
b) a single molecule DNA-targeting RNA comprising
i) a targeter-RNA that hybridizes with the target sequence, and
ii) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment,
wherein the activator-RNA and the targeter-RNA are covalently linked to one another with ...

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