The Patent Trial and Appeal Board has made its decision regarding the motions each party will be able to bring in Interference No. 108,048 between the Broad Institute and the University of California ("University") over CRISPR (an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats). As discussed previously, this interference will determine patent rights for CRISPR, which is part of a system for altering chromosomal sequences in situ in a cell in combination with a bacterially derived protein called Cas9, has been hailed as the "Breakthrough of the Year" for 2015, and rightfully so. CRISPR provides a mechanism for inserting or deleting specific DNA sequences using CRISPR-associate targeting RNAs and the Cas9 RNA-guided DNA endonuclease enzyme. It provides for the first time the type of specificity for altering DNA that the polymerase chain reaction (PCR) provided a generation ago for amplifying specific DNA, as illustrated by this schematic:
As part of the interference proceedings, each party proposed a set of motions directed to altering the procedural posture of the case and to challenge patentability of each other's patents or applications involved in the interference. Last Thursday, the Board ruled on whether it would authorize those motions; those decisions and the substance of the proposed motions are set forth below.
The Broad Institute suggested the following motions:
1. A motion that there is no interference in fact between its claims designated by the PTAB as corresponding to the Count (i.e., comprising interfering subject matter) and the University of California's claims. (Motions 2-13)
Permission to file this motion was GRANTED, as a threshold issue that could decide the interference at the beginning. As the Board explained, "[a] holding of no interference in-fact means that none of a party's claims meet the 'two-way' test for the existence of an interference under 37 C.F.R. § 41.203(a). Under such circumstances, no one has standing to proceed because the parties are not claiming interfering subject matter." Should the Broad Institute prevail, the parties would exit the interference with the claims corresponding to the Count, and the University should have its claims granted.
2. Thirty-three motions that the Broad's dozen patents involved in the interference should be accorded the benefit of priority to 16 provisional applications. (Motions 14-46)
Permission to file one motion on the priority issue was GRANTED but limited to no more than four provisional applications. In addition, the Broad Institute must provide a claim chart containing one column reciting the elements of the count and a second column providing "only citations to the asserted disclosure in the specification of the earlier application" but no other argument or information.
3. A motion that the University's claims corresponding to the count are unpatentable for lack of written description. (Motion 47)
Permission to file this motion was GRANTED as being directed to a threshold issue, which the Board explained would result in judgment against the University for lack of standing to participate in the interference.
4. A motion that the University's claims corresponding to the count are unpatentable for lack of enablement. (Motion 48)
Permission for this motion was DEFERRED because it "does not appear to impact the priority contest."
5. Motions that the University claims are not patentable over "certain prior art." (Motions 49-50)
Permission for this motion was DEFERRED for substantially the same reasons for deferring Motions 48.
6. A motion for access to the prosecution histories of the University's related, pending, unpublished applications, and that the University keep the Board and the Broad informed regarding the status of the claims of these applications with regard to whether the Examiner has issued a notice of allowance. (Motion 57)
This motion was DENIED regarding access but GRANTED regarding keeping the Board and the Broad Institute informed, and to keep the Examiner in each of these pending applications informed regarding the existence of the interference.
The University suggested the following motions:
1. 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. (Motion 1)
Consideration of this motion was DEFERRED because, as with some of the Broad Institute's claims, because this motion does not impact the priority questions before the Board. Unspoken but implicit in the Board's reasoning was that there were other avenues for challenging validity of the Broad Institute's patents (including, inter alia, inter partes review).
2. Five motions to change the count. (Motions 2-5)
Permission to file one motion was GRANTED, based on the University identifying the count that "best describes the interfering subject matter and sets the scope of admissible proofs in a way that is just to both parties, or in the alternative two claims if the University can show that both are necessary to describe the interfering subject matter (but cannot propose alterative counts).
3. A motion to have the Board give the University the priority benefit of its provisional application as a constructive reduction to practice of the original or alternative count. (Motion 6)
Permission to file this motion was GRANTED. As with a similar motion by the Broad Institute, the Board requires the University to file a claim chart containing one column reciting the elements of the count and a second column providing "only citations to the asserted disclosure in the specification of the earlier application" but no other argument or information.
4. A motion that the Broad's involved claims are anticipated by certain prior art. (Motion 8)
Permission for this motion was DEFERRED for substantially the same reasons for deferring the Broad Institute's Motions 48-50.
5. A motion that each of the Broad's patents are unpatentable under the doctrine of obviousness-type double patenting. (Motion 9)
Permission for this motion was DEFERRED for substantially the same reasons for deferring Motion 8.
6. A motion that each of the Broad's patents are unpatentable for improper inventorship. (Motion 10)
Permission for this motion was DEFERRED, with the Board advising that if relevant, it would be considered during the priority phase of the interference.
11. A motion that each of the Broad's patents were obtained by inequitable conduct. (Motion 11)
The Board DENIED authorization for this motion, stating that it was premature and that the substance of the allegations would "likely be apparent from the priority proofs."
In addition, each party filed a motion for judgment on priority grounds, which the Board DEFERRED until the priority phase of the interference.
In addition to these decisions, the Board also ordered that one of the University's allowed applications be added to the interference and that this application be included in the Broad Institute's motions 2 and 5 (that there is no interference in fact and that certain of the Broad Institute's claims do not correspond to the count, respectively) and the University's motion for substituting the count. Procedurally, the Board did not waive the requirement for a statement of facts to accompany each motion, nor did it extend the page limit for the motions. Both these decisions increase the pressure on the parties to address the complex issues in these motions. Finally, the Board did not extend the schedule for filing motions, responsive motions and oppositions to motions and replies, as well as objections and observations regarding evidence. The complete schedule is as follows:
TIME PERIOD 1 -- 22 April 2016
File motions
File (but serve one business day later) priority statements
TIME PERIOD 2 -- 13 May 2016
File responsive motions to motions filed in TIME PERIOD 1
TIME PERIOD 3 -- 24 June 2016
File oppositions to all motions
TIME PERIOD 4 -- 5 August 2016
File all replies
TIME PERIOD 5 -- 16 September 2016
File request for oral argument
File motions to exclude evidence
File observations
TIME PERIOD 6 -- 7 October 2016
File oppositions to motions to exclude
File response to observations
TIME PERIOD 7 -- 21 October 2016
File replies to oppositions to motions to exclude
DEFAULT ORAL ARGUMENT DATE -- 17 November 2016
If oral argument ordered
