For those who have been following this second round, this second interference concerns several of Broad's patents—and UC patents—issued *after* the first interference. Here's the docket: acts.uspto.gov/ifiling/Public… it's Interference No. 106,115 /2
The core of this 2d interference concerns who can claim priority to using a *single guide RNA* in a generic system, i.e., one piece of RNA for both prokaryotic and eukaryotic cells. /3
In theory, this is different from the first interference which focused on getting *any* Type-II CRISPR system to work in eukaryotic cells, specifically. /4
To that end, the Broad had four motions important for today's hearing: (1) to cancel the 2d interference in light of the decision in the first (estoppel); (2) to substitute the Broad's count (without a "fusing" requirement) for the one proposed by the PTAB... /5
(3) to de-designate certain of Broad's patents' claims if the proposed Count goes forward; and (4) to entitle Broad to the benefit of its earliest application 61,736/527 (Dec. 12, 2012). /6
U.C. (referred to as "CVC" in the briefs, i.e., California, Vilnius, and Charpentier) had essentially one one major motion: to afford it the benefit of its earliest application, 61/652,086 (May 12, 2012)—the same provisional from the first interference. /7
The executive summary, if you read no further, is this: I think—although this oral argument was tough to read—that the Broad is ultimately going to win on benefit for generic "fused" RNA claims, at which point we may have a testimonial phase. /8
Let's begin with a brief recap of the oral arguments themselves. Due to the #COVID19 pandemic, the oral arguments were held telephonically, mostly without major technical incident. /9
Presiding Judge Katz conducted the hearing, with her colleagues Judge Lane and Judge Moore present. Ray Nimrod of Quinn Emmanuel argued for Broad; Eldora Ellison of Sterne Kessler for CVC. /10
(One more procedural note: the arguments were almost entirely uninterrupted by the Judges, meaning they've also certainly already made up their minds.) /11
Broad began w/ recitation of why denying its estoppel motion would essentially be relitigating the prior interference, that stating that sgRNA claims in generic systems would create a conflict with the PTAB's prior decision on single-or-dual RNA claims in eukaryotic systems. /12
I don't think this is ultimately going to be successful for two reasons: (1) Were that true, the PTAB would not have declared this 2d interference—and sua sponte, I may add. And (2) the Broad's own claims differentiate the two. So that ship has almost certainly sailed. /13
The Broad then only *briefly* touched upon its request for a separate count and then discussed—at the urging of Judge Katz—which claims it considered to claim "fused" RNA systems from those with dual RNAs. (Yet another reason why Broad's Mot. No. 1 is likely to fail.) /14
Broad also spent a good deal of time knocking down CVC's Motion No. 1 (on priority benefit) by suggesting that the PTAB's prior decision should have a preclusive effect on relitigating issues like written description and obvious on the CVC provisional. /15
CVC then stepped up to argue, with a full-throated defense that their earliest provisional ("P1" in its papers) was a constructive reduction to practice of sgRNA systems in eukaryotic cells, and that nothing about a POSA's expectations of whether it should work... /16
should detract from the fact that it supported every element in the Count. They identified a "variety of cell types," "disclosed a chimeric sequence," and required a POSA to use only "well known molecular techniques" to cross the finish line in eukaryotes. /17
As evidence of this, they also cited to some post-filing evidence for proof of enablement. (That is, other labs got it to work immediately after filing.) /18
Quick aside: This was, essentially, the very impressive (I thought) demonstrative that Todd Walters put up at the 1st oral argument. CVC obviously didn't win that one, but the "6 labs got it to work argument" I always found persuasive. /19
Judge Katz did interrupt here for a question about why CVC, in its proofs, focused almost exclusively on microinjection in zebrafish. "Is there something special about fish cells?" Judge Katz wondered. /20
It was a dangerous question: Yes, and the specification could hardly be said to provide support for generic claims; No, and one could attack the presumption that others had what they needed in P1 to do the work. /21
I thought Ms. Ellison handled this deftly by pointing out that, simply, fish cells were a well-known tool in molecular biology, and subject to microinjection of RNPs in a way that didn't require upending any of the prior findings in the prior interference. /22
(And, Yes, I'm aware she has a PhD—and so may go by "Dr." not "Ms."—but I'm under the impression everyone gets the Ms/Mr salutation when referring to attorney argument. If you think that's wrong, feel free to @ me.) /23
At the same time, CVC then argued that WD and enablement were satisfied but CVC wasn't "looking to overturn anything." That's an *incredibly* difficult argument to make—how could a generic claim be enabled when a species claim wasn't, unless the generic also fails WD? /24
CVC concluded by stating that its earliest provisional provided "all that a POSA needed" to enable the Count. Again: a tough, tough case to make given the prior decision. /25
Broad pounced on this in rebuttal, noting that all this post-2012 work from third parties was (a) irrelevant because it's the *time of filing* that matters; and (b) already decided in the prior interference. (As a legal matter, I tend to agree.) /26
Broad also went through the lack of CVC's own eukaryotic work for 5 months between P1 and P2 (CVC's later provisional), including referring to exhibits—seemingly correspondence—between U.C. scientists and those from the Broad. /27
No further questions from the panel. On to CVC's rebuttal. CVC argued that the post-filing evidence is "worthy of consideration" and that Broad's estoppel arguments were trying to "avoid priority." /28
Judge Katz then stepped in and asked how CVC would interpret Broad's claims concerning whether to remove dual-guide RNA claims, to which CVC responded that the Board should essentially "ask Broad that" about what "fused" meant. /29
This was probably the opportunity for a concession but it didn't come, and the punting to the Broad fell flat. /30
As for the WD/enablement issue on generic systems, CVC argued that it provided sequence of a chimeric RNA that a POSA would have recognized—and Judge Katz jumped on this immediately by noting that CVC's own witness testified to the contrary. (!) /31
CVC then seemed to get around that by arguing that this was merely post-trascriptional modification that was part of any POSAs toolbox regarding methylation of uracil to thymine. (A good technical argument, but not sure it got around the witness issue.) /32
And then the case was submitted! If usual timelines are any guide, we should see a decision in about 2 months—so figure mid- to late-July. /33
So: where does this all leave us? Again: the questions from the panel, and it's sua sponte order of interference make me doubt Broad is going to get its estoppel motion. (It may get estoppel on facts, but not to bounce the prior decision.) /34
Similarly, given the argument on "fused" claims—as those in the Count—I also doubt Broad is going to get Motion No. 2. This is going to be the interference about single guide RNAs. /35
But I do ultimately think the Broad—rather than CVC—is going to get the earliest priority date on generic single guide claims (i.e., grant of Broad's Motion 4 and denial of CVC's motion 1) and some claims de-designated. /36
If that's the case, we'll need to go to a priority phase on invention—think lab notebooks and testimony from Doudna and Zhang, among others. /37
That will be ugly and unfortunate—as I predicted back in Dec. 29, 2015. law.stanford.edu/2015/12/29/the… But it's been brewing for a long time. /38
In the meantime, the technology has *wildly* eclipsed the claims at issue; we're about to cure genetic diseases using the methods fought over by both parties; the applications are well-beyond genome-editing; and we have new nucleases that are meaningless to this squabble. /39
This #patent litigation has taken on a life of its own. And perhaps the proceedings today will give us a clue about how—and when—it'll end. 40/40
