By Kevin E. Noonan --
On June 21st,* the Patent Trial and Appeal Board declared two new interferences involving CRISPR technology. The first, Interference No. 106,132, named Sigma-Aldrich as Senior Party and the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") as Junior Party, while the second, Interference No. 106,133 named Sigma-Aldrich as Senior Party and the Broad Institute, Harvard University, and MIT (collectively, "Broad") as Junior Party.
Each Interference names Sigma-Aldrich U.S. Application No. 15/456,204 as the involved application. In the '133 Interference, the following Broad patents are involved:
• U.S. Patent No. 8,697,359 - claims 1-20
• U.S. Patent No. 8,771,945 - claims 1-29
• U.S. Patent No. 8,795,965 – claims 1-30
• U.S. Patent No. 8,865,406 – claims 1-30
• U.S. Patent No. 8,871,445 – claims 1-30
• U.S. Patent No. 8,889,356 – claims 1-30
• U.S. Patent No. 8,889,418 – claims 1-28
• U.S. Patent No. 8,895,308 – claims 1-30
• U.S. Patent No. 8,906,616 – claims 1-30
• U.S. Patent No. 8,932,814 – claims 1-30
• U.S. Patent No. 8,945,839 – claims 1-28
• U.S. Patent No. 8,993,233 – claims 1-43
• U.S. Patent No. 8,999,641 – claims 1-28
• U.S. Patent No. 9,840,713 – claims 1-41
• U.S. Patent Application No. 14/704,551 – claims 2 and 4-18
• U.S. Patent Application No. 15/330,876 – claims 1, 16-21, and 30-40,
In the '132 Interference, the following CVC applications are involved in the Interference:
• U.S. Patent Application No. 15/947,680 – claims 156–185
• U.S. Patent Application No. 15/947,700 – claims 156–185
• U.S. Patent Application No. 15/947,718 – claims 156–185
• U.S. Patent Application No. 15/981,807 – claims 156–185
• U.S. Patent Application No. 15/981,808 – claims 156–170 and 172-185
• U.S. Patent Application No. 15/981,809 – claims 156–170 and 172-185
• U.S. Patent Application No. 16/136,159 – claims 156–184
• U.S. Patent Application No. 16/136,165 – claims 156–184
• U.S. Patent Application No. 16/136,168 – claims 156–184
• U.S. Patent Application No. 16/136,175 – claims 156–184
• U.S. Patent Application No. 16/276,361 – claims 3-31
• U.S. Patent Application No. 16/276,365 – claims 3-32
• U.S. Patent Application No. 16/276,368 – claims 3-31; and
• U.S. Patent Application No. 16/276,374 – claims 3-32.
(In each case these are the same patents and applications involved in the interferences with ToolGen (the '126 and '127 Interferences) and between Broad and CVC (the '115 Interference).
In the '132 Interference, Count 1 is, in the alternative, claim 156 of CVC's involved Application No. 15/981,807 or claim 31 of Sigma-Aldrich's involved Application No. 15/456,204:
Claim 156:
A eukaryotic cell comprising a target DNA molecule and 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, or a nucleic acid comprising a nucleotide sequence encoding said Cas9 protein; and
b) a single molecule DNA-targeting RNA, or a nucleic acid comprising a nucleotide sequence encoding said single molecule DNA targeting RNA; wherein the single molecule DNA-targeting RNA comprises:
i) a targeter-RNA that is capable of hybridizing with a target sequence in the target DNA molecule, and
ii) an activator-RNA that is capable of hybridizing 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 intervening nucleotides; and
wherein the single molecule DNA-targeting RNA is capable of forming a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule, whereby said system is capable of cleaving or editing the target DNA molecule or modulating transcription of at least one gene encoded by the target DNA molecule.
Claim 31:
A method for modifying a chromosomal sequence in a eukaryotic cell by integrating a donor sequence, the method comprising introducing into the eukaryotic cell:
(i) a Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)/CRISPR-associated (Cas) (CRISPR-Cas) type II protein linked to only one nuclear localization signal (NLS) or a nucleic acid encoding the CRISPR-Cas type II protein linked to only one NLS, wherein the CRISPR Cas type II protein is a Cas9 protein, and the nucleic acid encoding the CRISPR-Cas type II protein is codon optimized for expression in the eukaryotic cell;
(ii) a guide RNA or DNA encoding the guide RNA, wherein the guide RNA comprises a first region that is complementary to a target site in the chromosomal sequence, which target site in the chromosomal sequence is immediately followed by a protospacer adjacent motif (PAM), and a second region that interacts with the CRISPR-Cas type II protein, and wherein the guide RNA comprises a crRNA and a tracrRNA; and
(iii) a donor polynucleotide comprising the donor sequence and upstream and downstream sequences;
wherein the guide RNA guides the CRISPR-Cas type II protein to the target site in the chromosomal sequence, the CRISPR-Cas type II protein introduces a double-stranded break at the target site, and repair of the double-stranded break by a DNA homology-directed repair (HDR) process leads to integration or exchange of the donor sequence into the chromosomal sequence.
In the '133 Interference, Count 1 is, in the alternative, claim 18 of Broad's involved Patent No. 8,697,359 (dependent on claim 15) or claim 31 of Sigma-Aldrich's involved Application No. 15/456,204:
Claim 15:
An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system comprising a Cas9 protein and at least one guide RNA that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product and the Cas9 protein cleaves the DNA molecules, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together.
Claim 18:
The CRISPR-Cas system of claim 15, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.
All claims of all applications and patents of each party in each Interference were designated as corresponding to the Count.
The PTAB gave CVC a priority date that is the filing date of U.S. Provisional Application No. 61/757,640, filed January 28, 2013, and Sigma-Aldrich a priority date of U.S. Provisional Application No. 61/734,256, filed December 6, 2012.
The PTAB gave Broad a priority date that is the filing date of U.S. Provisional Application No. 61/736,527, filed December 12, 2013, and Sigma-Aldrich a priority date of U.S. Provisional Application No. 61/734,256, filed December 6, 2012.
It might be recalled (see "Sigma-Aldrich Wants Its Piece of CRISPR Pie" and "Sigma-Aldrich Tries Again") that Sigma-Aldrich, in its petition that the PTAB declare interferences with Broad and CVC, set forth the following priority timeline:
which certainly suggests the timing milieu that will be relevant to the Parties' priority positions.
The Board set a date of August 3, 2021, for the initial conference regarding proposed Preliminary Motions for each party. The details of these motions, and those the Board granted leave for each party to file, will be the subject of the next post.
* Our apologies for turning to these interferences in a somewhat untimely fashion. However, a review of the blog over the past several months suggests that posts involving these two interferences, in addition to the '115,'126,and '127 Interferences, might have been unnecessarily confusing.
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