By Kevin E. Noonan --
On June 24th, the U.S. Patent and Trademark Office declared an interference (No. 106,115) between patents and applications owned by the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (designated in the interference Declaration as the Junior Party) and the Broad Institute, Inc., the Massachusetts Institute of Technology, and the President and Fellows of Harvard College (designated as the Senior Party). As in the earlier interference between these parties on this subject matter, Administrative Patent Judge Deborah Katz was designated by the Office to manage the interference.
The Declaration explains the determination of which party is Senior and which Junior, by noting that the Office has not given the benefit of any earlier-filed priority application to either party. To the extent that Berkeley's applications were all filed last fall (as part of an apparent strategy to have this interference declared, although they did not formally provoke it), the decision not to grant the parties benefit mandates the Senior/Junior party designations. However, it can be expected that the parties each will file motions during the first phase of the interference to establish the benefit of the earliest priority possible.
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 together, wherein the guide RNAs comprise a guide sequence fused to a tracr sequence.
(where the underlined portion recites the relevant language from claim 18).
Claim 156 of Berkeley's U.S. Patent Application No. 15/981,807 provides the alternative count language:
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.
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. It will be recalled that the Broad and Berkeley attempted to file such motions in the first interference (see "CRISPR Interference Motions Set"). 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 (Berkeley, unless it 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 also contains the scheduling statement that there will be a telephone conference between APJ Katz and the parties on August 5th, and that four business days prior, 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.) In the last interference, the Broad filed a motion that there was no interference-in-fact (unlikely in this interference); several motions that the Broad's dozen patents involved in the interference should be accorded the benefit of priority to 16 provisional applications; a motion that the University's claims corresponding to the count are unpatentable for lack of written description (granted); a motion that the University's claims corresponding to the count are unpatentable for lack of enablement (deferred); motions that the University claims are not patentable over "certain prior art" (deferred); and motions for access to pending Berkeley applications (which was denied). Berkeley's motions were in some ways more compelling, to the extent they suggested grounds for invalidating the Broad patents that were foreclosed by the PTAB's determination that there was no interference-in-fact. These motions included: a motion that all of the claims of all of the Broad's patents are invalid over the publication of the University's application in interference, based on an error in how the Broad's application was filed involving changes resulting from the America Invents Act (deferred); five motions to change the count (one was granted but mooted by the Board's decision); a motion for priority benefit to an earlier provisional application (granted); a motion that the Broad's involved claims are anticipated by certain prior art (deferred); a motion that each of the Broad's patents are unpatentable under the doctrine of obviousness-type double patenting (deferred); a motion that each of the Broad's patents are unpatentable for improper inventorship (deferred); and a motion that each of the Broad's patents were obtained by inequitable conduct (denied).
What motions the parties file should be available on the PTAB website shortly after the August 5th teleconference and will be the subject of a future post.
One thing speeding up final decisions in interferences is that the Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. §146 pursuant to changes in the statute provided by the Leahy-Smith America Invents Act in Biogen MA, Inc. v. Japanese Foundation for Cancer Research. I.e., no more long delays by filing §146 civil actions between the PTAB decision and the Fed. Cir. appeal.
Posted by: Paul F. Morgan | July 09, 2019 at 10:00 AM
I think the significance of that decision is to put pressure on the parties to make sure the record was complete, because there will be less opportunity to supplement under a Section 146 proceeding.
Thanks for the comment.
Posted by: Kevin E Noonan | July 09, 2019 at 11:24 AM