Separate Interferences Declared between Toolgen and Broad and CVC over CRISPR Priority Question

McDonnell Boehnen Hulbert & Berghoff LLP
Contact

McDonnell Boehnen Hulbert & Berghoff LLP

One of the most notable movie taglines, "Just when you thought it was safe to go back in the water," was used to market the sequel to the original summer blockbuster movie, Jaws.

It is perhaps impossible to not think of that message upon learning that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office on December 20, 2020 declared two interferences:  the first, Interference No. 106,126 involving the Broad Institute, Inc., the Massachusetts Institute of Technology, and the President and Fellows of Harvard College, and the second, Interference No. 106,127, involving the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (each designated as the Junior Party) and each Interference naming Toolgen Inc. as Senior Party.

The '126 interference involves the following Broad patents and applications (and their involved claims, which constitute all of the granted claims of all of the Broad patents):

• 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,

against only one pending application for Toolgen:

• U.S. Patent Application Publication No. US20150344912 (Application No. 14/685,510) - claims 66-68, 70-74, 83, 85-88, and 90-94.

None of the claims of any of the patents or applications of either party were designated as not corresponding to the Count.

The count of the interference is set forth in the alternative, either as claim 18 of the Broad's U.S. Patent No. 8,697,359 (dependent on claim 15), which taken together recites the following invention:

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 togetherwherein the guide RNAs comprise a guide sequence fused to a tracr sequence.

(where the underlined portion recites the relevant language from claim 18);

or Claim 85 of Toolgen's U.S. Application No. 14/685,510:

An isolated mammalian cell comprising a Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas system for site specific, cleavage of a double-stranded target nucleic acid sequence in the isolated mammalian cell, wherein the CRISPR/Cas system comprises:
    a) a nucleic acid encoding a Cas9 polypeptide, wherein the Cas9 polypeptide comprises a nuclear localization signal and wherein said nucleic acid is codon-optimized for expression in mammalian cells, and
    b) a chimeric guide RNA comprising a CRISPR RNA (crRNA) portion and a transactivating crRNA (tracrRNA) portion,
    wherein the target nucleic acid sequence comprises a first strand having a region complementary to the crRNA portion of the chimeric guide RNA and a second strand having a trinucleotide protospacer adjacent motif (PAM), and
    wherein the Cas9 polypeptide and the chimeric guide RNA form a Cas9/RNA complex in the isolated mammalian cell and mediate double stranded cleavage at the target sequence.

The Declaration gives Broad the priority benefit to U.S. Provisional Application No. 61/736,527, filed December 12, 2012, and to Toolgen U.S. Provisional Application No. 61/717,324, filed October 23, 2012.

The '127 interference involves the following CVC applications (and their involved claims, which constitute all of the pending claims of all of the CVC patent applications):

• 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.

against only one pending application for Toolgen:

• U.S. Patent Application Publication No. US20150344912 (Application No. 14/685,510) - claims 66-68, 70-74, 83, 85-88, and 90-94.

The count of this interference is set forth in the alternative, either as claim 156 of the CVC's U.S. Application No. 15/981,807:

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 DNAtargeting 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.

or Claim 85 of Toolgen's U.S. Application No. 14/685,510:

An isolated mammalian cell comprising a Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/Cas system for site specific, cleavage of a double-stranded target nucleic acid sequence in the isolated mammalian cell, wherein the CRISPR/Cas system comprises:
    a) a nucleic acid encoding a Cas9 polypeptide, wherein the Cas9 polypeptide comprises a nuclear localization signal and wherein said nucleic acid is codon-optimized for expression in mammalian cells, and
    b) a chimeric guide RNA comprising a CRISPR RNA (crRNA) portion and a transactivating crRNA (tracrRNA) portion,
    wherein the target nucleic acid sequence comprises a first strand having a region complementary to the crRNA portion of the chimeric guide RNA and a second strand having a trinucleotide protospacer adjacent motif (PAM), and
    wherein the Cas9 polypeptide and the chimeric guide RNA form a Cas9/RNA complex in the isolated mammalian cell and mediate double stranded cleavage at the target sequence.

The Declaration gives CVC the priority benefit to U.S. Provisional Application No. 61/757,640, filed January 28, 2013, and to Toolgen U.S. Provisional Application No. 61/717,324, filed October 23, 2012.

As a reminder, an interference proceeds in two stages.  The first stage involves the parties presenting motions that can modify the count, have certain claims declared outside the scope of the count (or vice versa), seek to establish an earlier priority date, and ask for a finding that the claims are invalid under any of the provisions of the patent statute.  If these motions are not decided in a way that would disqualify one or both parties, then the interference will move to a second stage, where the Junior Party (Broad or CVC, respectively, unless either can establish an earlier priority filing date) will present its proofs of conception and reduction to practice and the Senior Party will be permitted to oppose.  The Senior Party is under no obligation to present proofs earlier than its earliest filing date unless the Junior Party evinces evidence of (at least) earlier conception.  In practice, the parties can both be expected to submit their priority evidence.

The declaration of each Interference also contains a scheduling statement; in the '126 Interference there will be a telephone conference between APJ Katz and the parties on February 4th at 1:00 pm EST, and in the '127 Interference there will be a telephone conference between APJ Katz and the parties on February 4th at 3:00 pm EST.  In each Interference, four business days prior to the telephone conference the parties will submit a list of motions it proposes to file.  (Except in instances where this list is vanishingly small, it is unlikely that the Board will grant the parties' motions to file all these proposed motions.)  It is likely that one or both of Broad and CVC will ask the Board to redeclare the interference between all three of these parties.

What motions the parties file should be available on the PTAB website shortly after the February 4th teleconference and will be the subject of a future post.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP
Contact
more
less

McDonnell Boehnen Hulbert & Berghoff LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.