By Kevin E. Noonan —

Late last month, Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence in Interference No. 106,115.  Now CVC has filed its Opposition to Broad's motion to exclude and Broad has filed its responsive Reply.

Broad's motion to exclude was specifically directed to testimony from Dr. Phillip Zamore regarding "how a person having ordinary skill in the art ("POSA") allegedly would have understood (1) the March 2011 Deltcheva et al. reference's disclosures regarding tracrRNA, (2) the RNAi, pre-mRNA, and DNA systems he alleges are relevant to Deltcheva et al.'s disclosures, and (3) Dr. Zhang's October 24, 2011 email regarding the role of tracrRNA in the CRISPR-Cas9 cutting complex."  According to Broad, what Dr. Zamore's declaration did not attest to was "(1) whether a 2012 POSA would have had a reasonable expectation of success of using CRISPR-Cas9 in eukaryotic cells; (2) the state of the art after the Jinek 2012 paper; or (3) relevant prokaryotic-based systems, such as Group II introns," all of which were issues upon which CVC Priority Motion relied.  But these issues were attested to not by Dr. Zamore in support of CVC's priority claims but by another witness, who did not opine on them.  Thus, CVC's proffer of Dr. Zamore's testimony on these matters was an attempt, in Broad's view, to "untimely seek[] to obtain expert testimony on these topics via improper re-direct testimony by Dr. Zamore" (i.e., during Broad's cross-examination of CVC's witness).  And Broad asserted that its cross-examination of Dr. Zamore was properly limited to "the actual opinions expressed in Dr. Zamore's declaration and his qualifications," and thus did not "open the door" to the testimony CVC elicited on redirect examination.

CVC opposes Broad's motion to exclude on the grounds that Dr. Zamore's testimony on redirect was within the scope of Broad's cross-examination and was proffered to "clarify facts that were not made sufficiently clear by either cross examination or direct examination" and that Broad's assertion of prejudice is unfounded.  Moreover, CVC asserts that it is "'entirely appropriate' to admit testimony elicited on redirect even where that testimony extends beyond the scope of cross-examination," citing Taskett v. Dentlinger, 344 F.3d 1337, 1339 (Fed. Cir. 2003).  And CVC resorts to 37 C.F.R. § 1.671(b) and Fed. R. Evid. 611(b) for the rule that redirect testimony in proceedings before the PTAB were permissible where such testimony "clarify[ies] facts that were not made sufficiently clear by . . . cross examination."  Because Broad's motion does not address these standards nor assert a basis in view of them for CVC's purported transgression thereof, CVC's Opposition maintains that Broad fails to provide the Board with any basis for granting their motion.  CVC further argues that Broad has failed to establish any prejudice to itself, because Broad has had a "full and fair opportunity to re-cross Dr. Zamore" under 37 C.F.R. § 42.53(c)(2), but "chose not to do so."

CVC's Opposition sets forth in detail, point by point under interference rules, its basis for contending that Broad did not establish a basis for the Board to grant their motion to exclude.  CVC alleges that Broad has mischaracterized Dr. Zamore's redirect testimony, which was directed (in CVC's view) to a question that "has been discussed in nearly every filing throughout the course of this Interference": whether a person of skill in the art "would have understood the sgRNA CRISPR-Cas9 system to work in eukaryotes without needing any special instructions or conditions, based on the skilled artisan's experience with comparable prior art systems."  CVC's brief sets forth the dynamics of the testimony elicited from this witness by Broad during its cross-examination and CVC's questions on redirect examination, supporting its assertion that the testimony Broad seeks to exclude is properly within the scope of Broad's cross-examination.  CVC asserts accordingly that to the extent that Dr. Zamore's testimony was "expanded," the Board can consider it "provided such testimony provides the PTAB valuable clarity and context for his previous answers, many of which answered questions from Broad's counsel that were confusing or misleading in the absence of an understanding of the broader implications of the discussion," citing Taskett.  These relationships between Broad's questioning on cross-examination and CVC's redirect are set forth in this table:

The Opposition brief further exemplifies CVC's argument specifically as relates to its inquiry on Dr. Zamore's redirect testimony regarding comparisons (elicited on Broad's cross-examination) between CRISPR-Cas9 and other RNA-based regimes ("[r]ibozymes, Group II introns, and riboswitches").  CVC contends these are not the most compatible prior art systems, as Dr. Zamore explained for the Board's benefit on re-direct (testifying that "ZFNs and TALENs are far more comparable than any of these RNA systems").  In view of the clarifying nature of this testimony, CVC argues that there no basis to exclude it under Taskett or other Federal Circuit precedent.

CVC further contends that there is no prejudice to Broad, because the topics that were the subject of Dr. Zamore's redirect testimony were "not news" and that "[n]othing in Dr. Zamore's redirect testimony raised any issues that Broad and its experts have not already briefed extensively," noting that Broad had proffered Dr. Breaker's expert witness testimony on these issues.

Finally, CVC argues that Broad had the opportunity under 37 C.F.R. § 42.53(c)(2) to recross Dr. Zamore but did not do so.

Broad's Reply repeats the arguments already made in Broad's Motion to Exclude, here calling CVC's Opposition arguments "a transparent attempt to circumvent the rule against submitting reply declarations without leave."  Broad ties these efforts to the Board's earlier denial of CVC's request for leave to file reply declarations with regard to CVC Reply 2 (see "CVC Files Reply to Broad's Opposition to CVC's Priority Motion").  Broad's Reply discusses in detail the scope of Dr. Zamore's testimony on cross-examination and on re-direct, arguing that his cross-examination testimony was far less expansive than CVC contends.  The Reply notes that Dr. Zamore's declaration was filed in support of CVC's Opposition to Broad's priority motion and that nothing in either the Opposition nor the declaration was directed to questions of whether the skilled worker would have had a reasonable expectation of success at operable CRISPR-Cas9 in eukaryotic cell nor comparisons to other prior art systems.  Broad points out that these considerations apply to CVC's Priority Motion (fairly, because Broad itself has put these issues into question) and that CVC's expert asserted in support of CVC's priority motion did not address these issues.

Broad supports its argument that the Board should exclude this evidence as CVC overreach by noting that CVC has not cited anything (not "a single page") in Dr. Zamore's declaration that supports its argument that the Board should not exclude this testimony.  Moreover, Broad argues that:

Dr. Zamore's declaration does not contain any discussion of the obstacles and difficulties presented when adapting a prokaryotic system, such as CRISPR-Cas9, for use in a eukaryotic cell, nor any discussion of prior art systems such as Group II Introns or ZFNs/TALENs—indeed, Dr. Zamore's declaration does not contain a single mention of those systems.  These topics and systems have long been live issues here, and there is no excuse for CVC to have neglected addressing them in the declarations served with its Priority Motion.

Even if this were not the case, Broad argues that CVC cannot be permitted to "grossly expand the scope of his declaration via re-direct to systems not even mentioned in the declaration" (specifically Group II Introns and ZFNs/TALENs)(emphasis in Reply).  Broad asserts that its cross-examination was limited to the opinions he expressed in his declaration and what CVC attempts to introduce in testimony Broad opposes because it goes beyond this testimony and unfairly prevents Broad from cross-examining Dr. Zamore on these issues (despite any culpability Broad may have for failing to re-cross Dr. Zamore during his deposition).

Broad also reiterates its argument in its Motion to Exclude that the testimony it asks the Board to exclude was "a clearly prepared Q&A with CVC's counsel on re-direct on all three systems," i.e., Group II Introns, ZFNs and TALENs.  Broad set forth with specificity its challenges to the portions of Dr. Zamore's cross-examination testimony CVC cites in support of its arguments against the Board excluding this evidence, contending that these portions do not support the scope of the redirect testimony CVC attempts to include and nor does the authority CVC cites as favoring its position (including Taskett and Chrimar Holding Co., LLC v. ALE USA Inc., 732 F.App'x 876 (Fed. Cir. 2018)).

In response to CVC's assertion that Broad squandered its opportunity to re-cross examine Dr. Zamore on his redirect testimony Broad argues that:

[A]ll this does is highlight the unfairness and prejudice of CVC's canned re-direct.  There was no surprise to CVC that it needed to address [reasonable expectation of success] and prior art systems with a declaration in support of its opening Priority Motion.  CVC decided not to do so, and then ambushed Broad by eliciting it on Dr. Zamore's re-direct.  Broad did not have an opportunity to submit a rebuttal declaration and evidence or prepare a considered cross-examination of a properly disclosed opinion from Dr. Zamore.  To contend Broad should have cross-examined Dr. Zamore on his undisclosed and improperly elicited "re-direct" confirms that prejudicing Broad was CVC's goal—not merely a byproduct of its improper re-direct.

The Board will decide whether to exclude this or any other testimony included in the Parties' Motions prior to Oral Hearing, for which the Board has not set a date.

By Kevin E. Noonan —

Late last month, Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence in Interference No. 106,115.  Now Broad has filed its Opposition to CVC's motion and CVC has filed its responsive Reply.

CVC's motion was directed to testimonial declarations of several Broad witnesses, including Benjamin Davies, Mark Kay, Alan Lambowith, Paul Simons, Erez Lieberman Aidan, Greg Hannon, Mark Isalan, Caixao Gao, Adam Bogdanove, Thierry VandenDriessche, Bryan Cullen, Paula Cannon, and Ronald Breaker, as well as documentary evidence.  CVC's basis for its motion was that this witness testimony had not been subject to cross-examination, based on the Federal Rules of Evidence, Standing Order (SO) ¶ 157.3, 37 C.F.R. § 42.51(c), and precedent including Rose v. Frazer, Praxair Distrib., Inc. v. INO Therapeutics LLC, and Mexichem Amanco Holdings S.A. de C.V. v. Honeywell Int'l, Inc.  CVC also asserted that certain testimony, particularly that of Dr. Breaker, was hearsay.  CVC raised similar hearsay objections to Broad's proffer of two books about CRISPR, by Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race) and Kenneth (sic) Davies (Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing).

Broad's opposition to this motion asserts existentially that CVC is attempting to avoid contemporaneous evidence regarding the inventors' appreciation that they had (or through the exercise of routine practice could) reduce eukaryotic embodiments to practice during the time from CVC's alleged conception date (March 3, 2012) to the constructive reduction to practice date, the filing of CVC's earliest priority document U.S. provisional application no. 61/757,640, filed January 28, 2013.  Reciting an argument made throughout this interference (and, indeed, in the earlier interference between the parties, No. 106,048), Broad asserts that the evidence it has adduced in this regard is admissible at least as an admission against interest.  And, Broad argues, its witness Dr. Breaker was entitled therefore to rely on them in support of his opinion that CVC has not shown that it was in possession of eukaryotic CRISPR earlier than Broad's dates of conception and actual reduction to practice.

In addition, Broad argues that much of the evidence objected to by CVC involves opinions from scientists regarding whether the person of ordinary skill would have considered eukaryotic embodiments of CRISPR to involve nothing more than the exercise of ordinary skill and to have been reasonably expected to succeed in view of CVC's evidence regarding in vitro experiments.

Broad's opposition also specifically addresses particular evidentiary items (e.g., Exhibit 3681, Issacson's Codebreaker) (conceding that should the Board consider CVC's objection to have any merit the issue is one of weight not admissibility).  Broad makes the equitable point that CVC should not "be allowed to tell science writers and the public about the difficulties and obstacles of their eukaryotic work so they can seek public acclaim" and then have the PTAB "ignore that those statements contradict CVC's arguments here, where CVC contends the same work actually required only 'routine techniques' and 'ordinary skill.'"  Broad then cites examples of inconsistencies between the statements CVC has made in this interference and what was said in the Exhibit regarding whether reducing eukaryotic CRISPR to practice was difficult or routine.

Broad's legal basis for its opposition to CVC's motion to exclude is that a party admission is not hearsay under Fed. R. Evid. 801(d)(2) and Rawlings v. Kentucky, 448 U.S. 98 (1980).  Even if not falling under this hearsay exception, Broad argues, Dr. Breaker as an expert is permitted to rely on these statements under Fed. R. Evid. 703.  As for reliability, Broad argues that the statements at issue are ones the PTAB relied upon in Decisions on Motions in this interference and the '048 Interference.  Broad argues "[t]hese statements are relevant and admissible as directly contradicting the inventors' present testimony" and Dr. Breaker was able to consider them in forming his opinions.  And the status of the statements in Issacson's book as "double hearsay"  under Fed. R. Evid. 805 is not to the contrary to Dr. Breaker's ability to consider and rely on them under Rule 703 and In re Biogen '755 6 Patent Litig., No. CV102734, 2018 WL 3613162, at *10 (D.N.J. July 26, 2018).

The Broad also argues that Dr. Breaker permissibly relied on admissible, contemporaneous, factual accounts of scientists' opinion regarding whether eukaryotic CRISPR would be reasonably expected to succeed in view of the in vitro experiments disclosed in the Jinek 2012 reference.  Broad bases these arguments on (what it characterizes as) both parties (and their experts) having relied on public statements from scientists in the field to assert evidence on "the state of the art, how POSAs reacted to historical research and developments in the gene editing and CRISPR fields, and how various scientists reacted to the disclosure of Jinek 2012's in vitro experiments," as well as the Board's reliance on this evidence.  This argument sets forth in parallel the equivalence of CVC's expert's reliance on such evidence and Broad's as well as correspondence between this evidence and publicly available records of these and other scientists' comments on the expectation of the skilled worker on reducing eukaryotic CRISPR to practice.

The opposition (under PTAB rules in interferences) then sets forth a line-by-line rebuttal of the legal bases of the assertions in CVC's motion to exclude.  And Broad addresses what it describes as "similar but slightly different issues" regarding CVC's objections to the Lambowith declaration specifically related to "trying (and failing to adapt Group II introns for use in eukaryotic cells."

Finally, Broad sets forth its rebuttal to CVC's objections to specific Exhibits comprising figures relied upon by Dr. Breaker in his expert testimony.

CVC in its Reply sets forth its grounds for the Board to grant its motion.  Most of these arguments reiterate arguments made in its motion, focusing on the statements by the authors (Issacson and Davies) as "double hearsay" in violation of Fed. R. Evid. 805 and re-emphasizing violation of the rule set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 593-94 (1993) (an argument Broad does not address in their Opposition).  CVC disputes Broad's assertions that as publicly available statements much of what CVC has objected to should be allowed (saying that Broad has cited no authority for this proposition), characterizing Broad's use of this hearsay as "unapologetic" and that Broad should not be permitted to "cure its defiance of the Rules [of Evidence] through further defiance."  CVC also emphasizes Broad's failure to provide CVC with an opportunity to challenge these witnesses over this evidence (which even though being a practical impossibility might not excuse it).  CVC makes a distinction between relying on "scholarly journal articles, written by scientists for the scientific community and subject to rigorous peer-review" with what they characterize as "statements prepared for advocacy purposes during adversarial proceedings or ex parte prosecution, and not subject to any review (by cross-examination or otherwise)."

Next, CVC argues that Broad's purpose for submitting this evidence can be distinguished from the purpose to which CVC and the Board have relied upon public statements.  That distinction is that the Board and CVC have cited such statements "as examples of information on which a hypothetical person of ordinary skill in the art might base his or her expectations of success—something that does not turn on whether the statements are true or reliable."  In contrast, CVC argues, Broad is submitting these statements for the truth of the matter asserted (as an example, "whether the witness believed the CVC inventor's CRISPR-Cas9 system would work in eukaryotes, and what obstacles they expected to encounter"), where "[m]ost of these witnesses do not appear to have sworn any oath, nor have any of them been offered for cross-examination in any forum."  Asserting that "[i]f ever there were a model situation to exclude declaration testimony, this is it," CVC asks the Board to exclude the specific Exhibits set forth in its Motion to Exclude.

CVC's Reply then turns to portions of Dr. Breaker's Declaration.  These portions are merely an attempt for Broad to "backdoor so-called 'factual accounts'" and deny CVC the opportunity for cross-examination, CVC argues.  In addition, CVC notes that Dr. Breaker is being advanced as a scientific expert and "witness declarations from adversarial proceedings are not the type of documents that experts in Dr. Breaker's field reasonably rely upon to draw scientific conclusions," citing United States v. Tran Trong Cuong, 18 F.3d 1132, 1143 (4th Cir. 1994), authority supported by similar statements by the Federal Circuit (see Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366 (Fed. Cir. 2021)).  Accordingly, CVC argues that Broad has "not met its burden of establishing that these declarations fall within the scope of Rule 703," that these portions of Dr. Breaker's declaration violate Daubert and the Standing Order, and that the Board should grant CVC's Motion that this portion of his testimony is inadmissible.

Finally, turning to the Issacson book, CVC characterizes this as "media coverage" which is inadmissible "to prove sequences of events or an inventor's mental state," citing New England Mut. Life Ins. Co., v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989), and Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993).  In addition, CVC's Reply makes a distinction between the Board's citation of a book written by one of the inventors and this book written by a third party, reiterating its allegations that this evidence is inadmissible double hearsay.  (CVC also notes that Broad did not oppose CVC's motion to exclude Exhibits 6107 and 6116.)

CVC's Opposition to Broad's Motion to Exclude portions of its evidence and Broad's Reply will be the subject of a later post.