On Monday, August 26, 2019, the Patent Trial and Appeal Board (PTAB) issued an Order deciding which of the parties' (University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier, Junior Party, abbreviated to "CVC" throughout, and The Broad Institute, Massachusetts Institute of Technology, and Harvard University, Senior Party) proposed motions it will deign to consider in the first (appropriately called "motions") phase of the newly declared interference regarding priority of invention to CRISPR technology. The Board also and separately redeclared the interference and by doing so avoided considering one of CVC's motions (that arrived at Berkeley's desired outcome nevertheless).
To recap, late last month the parties submitted to the PTAB their proposed motions for the initial phase of the interference. As is typically the case in these submissions, each party filed motions to place them in the best procedural position for the main event in the interference, a determination of who deserved priority to CRISPR, specifically embodiments of the technology for use in eukaryotic cells.
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 their opponents' 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 (CVC, 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.
Turning to the Board's decision, their Order considered the Broad's motions first. The Broad's motions were predicated on their contention that this interference is "barred by res judicata, collateral estoppel, and law of the case" over the earlier-concluded interference (No. 106,048). The Broad's Motion 1 under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) is for judgment based on interference estoppel, citing MPEP § 2308.03(b): "A judgment of no interference-in-fact bars any further interference between the same parties for claims to the same invention as the count of the interference"; the Broad asked that this motion be expedited. Motion 2 under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) is related, for judgment based on CVC's failure to add a claim in the '048 interference reciting the linkage limitation, citing Woods v. Tsuchiya, 745 F.2d 1571, 1582 (Fed. Cir. 1985), and Ex parte Aoki, No. 2012-010117, 2015 WL 3827164 (P.T.A.B. June 15, 2015), for support. The Broad further requested the Board issue a Notice to Show Cause (considered by the Board to be Motion 3) why this interference is not precluded by judgment in the earlier '048 interference, based on the "showing" that CVC cannot antedate actual reduction to practice of applying CRISPR to eukaryotic cells in view of evidence of record in the '048 interference (CVC "cannot win on the merits" according to this portion of the Broad's argument).
The Board GRANTED authorization for the Broad to file one motion based on these various theories of estoppel, but because the Board realized that a decision in the Broad's favor would be dispositive (and perhaps indicating an inclination to agree with the Broad's position) the Board designated this motion to be expedited, setting a date of September 20th for the Broad to file its motion. CVC will be able to file an opposition only if the Board authorizes it after the Board has reviewed the Broad's motion.
The Broad's Motion 4 (contingent) under 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Motion 5 (contingent) under 37 C.F.R. 1 §§ 41.121(a)(1)(i) and 41.208(a)(2) asks the Board to substitute the count with an alternative count that would be "broad enough to cover Broad's best proofs," specifically:
Proposed Count 2 (Motion 4)
A method comprising:
introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
(I) a Cas9 protein or a nucleotide sequence encoding the Cas9 protein, and
(II) RNA or a nucleotide sequence encoding the RNA, the RNA comprising:
(a) a targeter-RNA or a first RNA, the first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and
(b) an activator-RNA or a second RNA,
wherein (II) (a) and (II) (b) are fused to one another or are covalently linked to one another with intervening nucleotides; and
wherein, in the eukaryotic cell, the activator-RNA or the second RNA form an RNA duplex with the targeter-RNA or the second ribonucleotide sequence, and the targeter-RNA or the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, and the DNA molecule is cleaved or edited or at least one product of 20 the DNA molecule is altered.
Proposed Count 3 (Motion 5):
A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule, or altering expression of at least one product encoded by the target DNA molecule, the method comprising:
contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered 8 Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated 9 (Cas) (CRISPR-Cas) system comprising:
a) a Cas9 protein,
and
b) RNA comprising
i) a targeter-RNA that is capable of hybridizing with the target sequence of the DNA molecule or a first RNA comprising (A) a first sequence capable of hybridizing with the target sequence of the DNA molecule and (B) a second sequence; and
ii) an activator-RNA that is capable of hybridizing to the targeter-RNA to form an RNA duplex in the eukaryotic cell or a second RNA comprising a tracr sequence that is capable of hybridizing to the second sequence to form an RNA duplex in the eukaryotic cell,
wherein, in the eukaryotic cell, the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence and the DNA molecule is cleaved or edited or at least one product of the DNA molecule is altered.
The Board GRANTED the Broad authorization to file one motion to substitute one of the proposed counts, that "describes the interfering subject matter and sets the scope of admissible proofs in a way that is just to both parties." The Board directed the Broad to ¶208.2 of the Standing Order for the requirements of motions to substitute a count.
Motion 6 through Motion 9, all under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(2) ask the Board to designate most of the Broad's claims as not corresponding to any or various permutations of the counts, in an effort to limit the Broad's exposure to losing their claims.
The Board GRANTED the Broad authorization to file one motion addressing whether these various claims correspond to the count.
Motion 10 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) requests priority benefit of the Broad's prior applications, having an earliest priority date of December 12, 2012; in view of the extensiveness of the list the Broad requests "at least" 35 pages for its motion and brief.
The Board GRANTED the Broad authorization to file one motion for priority benefit to one of these provisional applications. The Order also specifies the nature and form of the evidence (detailed claim charts) the Board wishes to see in support of this motion, absent any argument regarding the priority claim (although the claim charts do will not count against the page limit). The Board did not grant the Broad's request for additional pages over the page limit (25 pages; ¶121.2 of the Standing Order).
Motion 11 under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) seeks judgment against CVC on the grounds that the CVC claims are unpatentable for failure to satisfy the written description and/or enablement requirements of 35 U.S.C. § 112(a) and under 35 U.S.C. § 102(a) and/or 35 U.S.C. § 102(e) and 35 U.S.C. § 103, based on "the PTAB's binding finding that a POSA in 2012 would require the results of successful eukaryotic experiments to have a reasonable expectation of success that CRISPR-Cas9 could be made to work in eukaryotic cells, and given that D1 and D2 indisputably fail to disclose any eukaryotic experiments," and citing numerous scientific references (including Broad references).
The Board DENIED authorization to file this motion "because it will not further the inquiry into priority of invention of the count" and "because even if decided in favor of the Broad, would not be dispositive of the interference" because the invalidity grounds asserted in the proposed motion did not encompass all CVC's claims-in-interference. The portion of the motion directed to the prior art is DEFERRED because these issues are likely to overlap with the priority issues to be determined in the priority phase, according to the Board.
Motion 12 under 37 C.F.R. §§ 41.121(a)(3) asks the Board to require CVC to keep the Broad and the Board apprised of any notice of allowance in any pending, related applications.
The Board DENIED authorization to file this motion, but (in boldface type) notified the parties that "both parties are required to file a notice with the Board if a notice of allowance is issued for claims that share the priority chain of the currently involved claims." The Order also notes that the other requests regarding CVC's applications are moot in view of the redeclaration, including these applications within the scope of the interference.
The Broad's final motion, for priority, is DEFERRED because it will only be relevant if the parties reach the priority phase.
With regard to CVC's Motions, Motion 1 is an "expedited" miscellaneous motion under 37 C.F.R. § 41.121(a)(3) for benefit of an earlier non-provisional application and for the Board to redeclare the interference with CVC as the Senior party. The basis for this motion is that the specification of the applications-in-interference have an identical specification to CVC's USSN 13/842,859, filed 3/15/2013 (pre-AIA). CVC asked the Board to take these actions sua sponte because identical specifications are entitled to priority under 35 U.S.C. § 120. CVC's Motion 2 requests benefit of priority to earlier provisional and non-provisional applications.
The Board GRANTED authorization to file one motion that will not be expedited, and the Board refused to grant priority sua sponte. As with the Broad's motion, the Board will grant priority to only one of the asserted priority applications (and the Board cautions that it does not need arguments regarding applications for which the Board has accorded priority benefit). Also, the Board expressly did not authorize any increase in the page limit for this motion.
Motion 3, under 37 C.F.R. § 41.121(a)(1), asks the Board to treat the Broad's claims under the changes in the law effected by the Leahy-Smith America Invents Act with regard to Section 102 and 103 of the Patent Act, and for judgment that these claims are unpatentable under 35 U.S.C. § 103 over U.S. Patent Application Publication No. 2016/0298138. Motion 4 asks for judgment of unpatentability if the Broad applications and patents are entitled to pre-AIA treatment, under 35 U.S.C. § 103 over US 2016/0298138 to Sigma in view of extensive prior art contained in the Appendix.
The Board DEFERRED authorization of these motions until the priority phase because, as above, resolution of these issues would not be dispositive, and because the Board will still need to decide the priority issue under 35 U.S.C. §102(g).
Motion 5, under 37 C.F.R. § 41.121(a)(1) asks for judgment of unpatentability under 35 U.S.C. § 102(f) or (if post-AIA) 35 U.S.C. § 115(a) for "failure to name all inventors of the alleged invention.
The Board DEFERRED authorization of these motions until the priority phase because "the facts of inventorship may overlap with the facts of priority."
Motion 6 under 37 C.F.R. § 41.121(a)(1) asks for the Board to find the Broad liable for inequitable conduct.
The Board DENIED authorization for CVC to file this motion, on the basis that it is premature, and these issues may overlap with issues arising during the priority phase. The Order does permit CVC to request authorization for this motion at the conclusion of the priority phase.
Motion 7 is a miscellaneous motion under 37 C.F.R. § 41.121(a)(3) to add CVC's U.S. Application Nos. 16/276,361; 16/276,365; 16/276,368; and 16/276,374 to the interference.
The Board DENIED authorization to file this motion on the grounds it is moot because the Board redeclared the interference and included these applications.
Like the Broad, CVC asked authorization to file a motion for priority, which the Board DEFERRED because it will only be relevant if the parties reach the priority phase.
The Board also authorized CVC to file a miscellaneous motion that its Priority Statement be filed under seal. The Board set an expedited schedule to be filed September 5th and, as with the Broad's expedited motion no opposition is authorized unless the Board deems it necessary. The Order cautions that the interference and CVC's applications are publicly accessible and suggests that only "personal information" would likely be permitted to be redacted or filed under seal.
The Order also specifies that the parties should consolidate arguments rather than ask for extra pages in their briefs. Statements of material facts also are not waived and will be included in these page limits but claim charts will not.
The Order concludes with the schedule of the motions for each party as follows (with the caveat that while the deadlines for Time Periods 1-6 can be changed by stipulation neither Time Period 7 nor the default Oral Argument date can be changed):
TIME PERIOD 1 October 4, 2019
File motions
File priority statements
(but serve one business day later)
TIME PERIOD 2 October 25, 2019
File responsive motions to motions
filed in TIME PERIOD 1
TIME PERIOD 3 December 6, 2019
File oppositions to all motions
TIME PERIOD 4 January 17, 2020
File all replies
TIME PERIOD 5 February 28, 2020
File request for oral argument
File motions to exclude evidence
File observations
TIME PERIOD 6 March 20, 2020
File oppositions to motions to exclude
File response to observations
TIME PERIOD 7 April 3, 2020
File replies to oppositions to
motions to exclude
DEFAULT ORAL ARGUMENT DATE TBD
Separately, the Board redeclared the interference to add four of CVC's pending applications to the interference. There are no other changes to the declaration; the Broad and its co-owners remain Senior Party and CVC remains Junior Party (although as the Board noted in its accompanying Order this could change depending on the outcome of the motions the parties are authorized to file), nor were there any other changes in the patents and applications in interference, the accorded priority benefits nor the claims for each party corresponding to the count (i.e., substantially all of them). As the interference has been set out the Board seems ready to address all remaining issues between the parties to produced (subject to appeal) a final determination of who owns CRISPR.
Except, of course, for Sigma-Aldrich's claims, which are unmentioned both in the redeclared interference, the Board's Order or the conference call between the parties and the Board earlier this month.
