By Kevin E. Noonan —

In its turn, on September 17th, Senior Party ToolGen Inc. filed its Motion to Exclude certain evidence presented by Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") in Interference No. 106,127.  CVC filed its Opposition to ToolGen's motion on October 8th, and ToolGen filed its Reply on October 15th.

ToolGen's motion objected to the following ten exhibits (or portions of them):

1. Paragraphs 38-66, Bailey declaration Ex. 2015 (under FRE 702(b) and (d))
2. Paragraphs 28-39 and 40-86 Ex. 2477 (FRE 702(b) and (d))
3. Sontheimer declaration Ex. 2019 (FRE 602, 701(c), 702)(lay opinion)
4. Barrangou declaration Ex. 2021 (FRE 602, 701(c), 702)(lay opinion)
5. Doudna declaration Ex. 2023 (FRE 602, 701(c), 702)(lay opinion)
6. Sternberg declaration Ex. 2221 (FRE 602, 701(c), 702)(lay opinion)
7. Carroll declaration Ex. 2348 (FRE 602, 701(c), 702)(lay opinion)
8. Doyon declaration Ex. 2013 (relevance, improper expert testimony)
9. Zamore declaration Ex. 2017 (relevance, improper expert testimony)
10. Marrafini Interference No. 106,115 deposition testimony Ex. 2455 (hearsay)

ToolGen's objections under Fed. R. Evid. 702 sounded in the sufficiency of the facts and data underlying the testimony (Fed. R. Evid. 702(b)) and whether the expert had "reliably applied the principles and methods to the facts of the case" (Fed. R. Evid. 702(d)).  The remainder of the objections were directed to the various expert declarations submitted by CVC, and Dr. Marrafini's deposition transcript from the '115 Interference between CVC and Broad.

With regard to Exhibits 2015 and 2477 (Declarations of Scott Bailey, Ph.D.), ToolGen argued that Dr. Bailey's testimony that ToolGen is not entitled to priority to its P1 (US 61/717,324 application, filed October 23, 2012), P3 (US 61/837,481 application, filed June 20, 2013) and PCT applications (PCT/KR2013/009488, filed October 23, 2013) contradicts his testimony regarding CVC's alternative of Count 1 with regard to whether "a codon-optimized Cas9 nucleic acid and a nuclear localization signal ("NLS") is required to provide an adequate written description of ToolGen's claims."  ToolGen asserted that Dr. Bailey testified as he did in Exhibits 2015 and 2477 "upon instructions provided by CVC's lawyers that contradict the facts."  These allegations were based on statements in Dr. Bailey's testimony that he was "asked by counsel to assume that in the context of Embodiment 3-1, ToolGen's P3 must describe an embodiment of an NLS-tagged, codon-optimized Cas9 mRNA for expression in mouse cells[.]"  This contravenes Fed. R. Evid. 702(b), ToolGen argued, because "an expert must base his opinions on reliable facts and data" rather than by "blindly accepting CVC's lawyer-provided assumptions"; this is enough for the testimony to be stricken according to ToolGen, citing Tyger Constr. Co. v. Pensacola Constr. Co., 29 F.3d 137, 144 (4th Cir. 1994), and Paz v. Brush 20 Engineered Materials, Inc., 555 F.3d 383, 389 (5th Cir. 2009).  And, ToolGen argued, Dr. Bailey did not consider CVC's alternative Count.

The challenged declarations of Dr. Sontheimer, Dr. Barrangou, Dr. Doudna, Dr. Sternberg, and Dr. Carroll all suffer from the same defect, ToolGen argued: they constitute improper lay, rather than expert, opinion testimony.  They are nothing more than "CVC's post-hoc attempt to correct the declarants' contemporaneous doubts about CRISPR-Cas9 in eukaryotes, which CVC witnesses consistently expressed in the summer and fall of 2012," ToolGen asserts.  They are lay witness testimonies rather than expert testimony because "CVC made no showing qualifying them as expert witnesses, and the witnesses themselves testified that they were not submitting expert declarations and that they had offered no opinions at all about the sufficiency of disclosure in CVC P1 or P2" (emphasis in brief).  While the exact details of the declarations vary somewhat, the gist of ToolGen's objections were the same: the testimony by these witnesses as lay witnesses and not experts was impermissible because as such it "cannot be based on scientific, technical, or other specialized knowledge under FRE 701(c)."  The testimony from Drs. Sontheimer, Barrangou, and Doudna that ToolGen objected to had in common that the witnesses "opine[d] on the state of the CRISPR field and the content, contribution to the field, and reception by conference attendees (and indeed those not in attendance, too) of a presentation by Dr. Chylinski and Dr. Jinek at the June 21, 2012 Annual CRISPR Research Meeting."  ToolGen objected specifically to Dr. Doudna's testimony, which allegedly in part "could be straight from Dr. Doyon or Dr. Zamore's expert declaration."  Dr. Sternberg testified that "once the components of a system are identified in vitro, independent of a  particular cellular environment, it is reasonable to expect the system to work in a range of cellular environments, assuming routine adjustments," and Dr. Carroll said under oath that he "understood at the time of this [Sept. 2012] article that well-known molecular biology techniques could be used to apply the CRISPR-Cas9 system described in Jinek et al. in a eukaryotic cell" (which, ToolGen notes, is "the exact conclusion CVC and ToolGen's experts have extensively opined for and against in this matter").

Regarding Drs. Doyon's and Zamore's actual expert testimony, ToolGen's objection to the former was that the witness "based his opinion on post-filing exhibits," contrary to the rubric that satisfaction of both written description and enablement are judged by the understanding of the skilled artisan at the time the invention was made, citing In re Wright, 999 F.2d 1557, 1562-63, n.8 (Fed. Cir. 1993), and Application of Gunn, 537 F.2d 1123, 1128 (C.C.P.A. 1976).  The brief enumerated hundreds of such instances in support of this objection.  Another objection to Dr. Doyon's testimony was that it relied on declarations by other witnesses that are "irrelevant or improper lay testimony."  Another basis for ToolGen's objection was Dr. Doyon's reliance on private e-mails that are hearsay because they are "out-of-court statements offered for the supposed truth of the matter asserted," specifically "whether the CVC experiments showed successful reduction to practice of CRISPR-Cas9 in a eukaryotic system or whether CVC P1 described and enabled an embodiment of Count 1."  ToolGen also asked the Board to exclude Dr. Doyon's reliance on Dr. Jinek's laboratory notebook (which has not been corroborated by a non-inventor witness) and Dr. Doyon did not testify that he had independent personal knowledge.  Finally, ToolGen objected to Dr. Doyon's reliance on evidence he did not review.

ToolGen asserted reliance on post-produced material in support of its motion to exclude testimony from Dr. Zamore, on the same grounds for its objections to Dr Doyon's testimony.

Finally, ToolGen argued that Dr. Marrafini's testimony should be excluded as hearsay falling within no recognized exception.

CVC's opposition to ToolGen's motion to exclude focused on those objections that CVC contended boiled down to an opinion based on assumptions of legal requirements (inter alia, for enablement and written description), which CVC argued expert witnesses are permitted to make, citing Huawei Techs. Co. Ltd. v. Verizon Comms. Inc., 2:20-cv-00030-JRG at *8 (E.D. Tex. Jul 2, 2021).  Moreover, the contention that an expert's "assumptions are unfounded go to the weight, not the admissibility, of the testimony" CVC argued, citing Amorgianos v. Nat'l R.R. Passenger Corp., 303 F.3d 256, 266 (2d Cir. 2002) (quoting Daubert v. Merrill Dow Pharms. Inc., 509 U.S. 579, 593-94 (1993)."  CVC thus "admitted" that its expert witness based his opinion on "CVC's legal argument that ToolGen, in defending its accorded benefit, is estopped from relying on an embodiment in its P1 lacking a codon-optimized Cas9 nucleic acid or an NLS-tagged and codon optimized Cas9," taking the opportunity to reiterate CVC's position that "ToolGen argued to the Patent Office that codon-optimization and nuclear-localization sequences were critical to patentability of ToolGen's interfering claims, one of which is ToolGen's half of Count" in justification for its position.

Turning to ToolGen's arguments regarding exclusion of all or part of the declarations of Drs. Sontheimer, Dr. Barrangou, Dr. Doudna, Dr. Sternberg, and Dr. Carroll as being expert testimony submitted in the guise of lay testimony, CVC argued that "these witnesses are all scientists providing their personal recollections of historical events and understandings that they personally held during the relevant timeframe based on their first-hand knowledge of those events," which is admissible under Fed. R. Evid. 702 as well as Fed. R. Evid. 602 (personal knowledge).  CVC illustrates the propriety and admissibility of this testimony by citing Sitrick v. Dreamworks, LLC, 516 F.3d 993 (Fed. Cir. 2008), Supernus Pharm., Inc. v. Twi Pharm., Inc., No. 15-369 (RMB/JS), 2017 WL 4182809, at *20 n.12 (D.N.J. Sept. 21, 2017), and Braun Corp. v. Maxon Lift Corp., 282 F. Supp.2d 931, 934 (N.D. Ind. 2003), aff'd., 97 F. App'x 335 (Fed. Cir. 2004).  In CVC's view, declarations based on personal knowledge are not expert opinions, citing Freedom Wireless, Inc. v. Boston Commc'ns Grp., Inc., 369 F.Supp.2d 155, 157 (D. Mass. 2005).  This is particularly the case, CVC argued (understandably in view of the importance of the testimony to its case) regarding the declarants' reaction to "Drs. Chylinski and Jinek's seminal June 2012 presentation at the CRISPR conference" (where CVC's scientists presented single molecule guide RNA-dependent CRISPR for the first time), which CVC characterizes as "recollection regarding historical events that [the witness] personally observed."  CVC made similar arguments regarding testimony of Drs. Sternberg and Carroll.  And ToolGen's objections to Dr. Doudna's testimony received special attention in CVC's Opposition, the brief stating that, as "an inventor of CVC's CRISPR-Cas9 system" her testimony was based on "her specialized knowledge and experience" and {inventors may –- and often do — testify about their understanding of how their invention works, as well as when an invention was conceived and reduced to practice without being treated as experts," citing Voice Techs. Grp., Inc. v. VMC Sys., Inc., 164 F.3d 605, 615 (Fed. Cir. 1999).

CVC also addressed ToolGen's challenges of Dr. Doyon's and Dr. Zamore's testimony, on three grounds.  First, with regard to the bases of the objection CVC asserted that "ToolGen merely provides a naked string cite of exhibits purportedly published after the relevant filing date, with no substantive analysis of what these exhibits are, what they disclose, or the purpose for which Dr. Doyon cites them," which is proper, citing Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1344 (Fed. Cir. 2003), and Thomas & Betts Corp. v. Litton Sys. Inc., 720 F.2d 1572, 1581 (Fed. Cir. 1983).  Second, regardless of the validity of ToolGen's objections to the testimony of CVC's "fact" witnesses as set forth above, CVC argued that Dr. Doyon's "opinions are based on his own analysis of the extensive record evidence in this case" and they don't "automatically become unreliable just because he also read and considered consistent, supportive factual testimony set out in five declarations."  CVC similarly addressed ToolGen's objections to certain e-mails Dr. Doyon reviewed as well as to  Dr. Jinek's laboratory notebook.  Third and finally, CVC challenged ToolGen's narrative that Dr. Doyon did not review material he later relied upon.  Rather, CVC argued that Dr. Doyon merely testified that he could not recollect whether he did or he didn't.

For ToolGen's arguments regarding admissibility of Dr. Zamore's testimony, CVC reiterates its arguments that "there is nothing per se inadmissible about articles that were published after the relevant filing date.  Such articles can still be probative of what a skilled person would have understood at the time of filing" CVC contended, citing Plant Genetic, 315 F.3d at 1344.

Finally, turning to Dr. Marrafini's testimony, CVC argued that deposition testimony is admissible under "various hearsay exceptions" (Fed. R. Evid. 804(b)(1),(3); Fed. R. Civ. P. 32(a)(8)) and ToolGen had had the opportunity to cross-examine him on this testimony and waived it, citing Fed. R. Evid. 801(d), 803(b)(and making the further point that to the extent that Dr. Marrafini is indeed not available this provides further support for the Board's consideration of this testimony, under Fed. R. Evid. 804(b)(1); Cf. Fed. R. Civ. P. 32(a)(4)).

ToolGen's Reply addresses CVC's argument that expert witnesses are permitted to rely on assumptions by asserting that they are not permitted to rely on incorrect or unsupported legal assumptions or ones that are contrary to facts the witness admits, citing Paz v. Brush Engineered Materials, Inc., 555 F.3d 383, 389 (5th Cir. 2009).  ToolGen challenges CVC's arguments regarding Drs. Sontheimer, Dr. Barrangou, Dr. Doudna, Dr. Sternberg, and Dr. Carroll testimony as being far more that their personal recollections, stating that each of them are "rife with scientific, technical and other specialized knowledge offered to argue that a POSA would view Jinek 2012 or the Chylinski-Jinek presentation as describing or enabling CRISPR-Cas9 in eukaryotic cells."  And just because Dr. Doudna is an inventor ToolGen states that does not exempt her from the provisions of Fed. R. Evid. 701.

As for Drs. Doyon's and Zamore's testimony, ToolGen asserts that Dr. Doyon specifically and affirmatively testified that he did not review sequencing data ("the critical, distinguishing piece of Jinek 2013") upon which his testimony was based.  ToolGen cites as an example contrary to CVC's broad assertion that experts are permitted to consider and rely on post-filing evidence, an instance where, "to support his argument that a POSA in January 2013 would have known Cas9 would not have been active below 20°C, Dr. Doyon cites only 2017 and 2019 publications."  And ToolGen continues to cite the impropriety of Dr. Doyon relying on hearsay e-mails and an unauthenticated lab notebook at arriving at his opinions.  ToolGen merely states that these same arguments apply with regard to Dr. Zamore's testimony.

As to Dr. Marrafini's deposition ToolGen argues that it had attempted (unsuccessfully) to depose Dr. Marrafini in Interference No. 106,126 against Broad but was denied the opportunity.

The Board will render its decision prior to Final Hearing in this Interference.

By Kevin E. Noonan —

On September 17th, Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") filed its Motion to Exclude certain evidence presented by Senior Party ToolGen Inc. in Interference No. 106,126.  ToolGen filed its Opposition to CVC's motion on October 8th, and CVC filed its Reply on October 15th.

CVC objected to but two ToolGen exhibits, as set forth in this Table:

In its brief, CVC noted that it had preserved its objections under 37 C.F.R. § 41.155(b)(1) by timely filing 7 days after ToolGen served these exhibits.  On the merits, CVC supported its objection to Ex. 1283 being that the YouTube video of Dr. Dana Carroll was "juxtaposed with untitled graphics and drawings in a different window."  ToolGen, CVC asserted, failed to authenticate the video, i.e., provided no substantiating testimony through a witness subject to cross-examination.  Nor, according to CVC, did ToolGen provide any "evidence regarding who posted this video and when, whether it was edited, and whether it accurately portrays Dr. Carroll's opinions or understandings, especially with respect to the purposes for which ToolGen cites it."  And nor, argued CVC, did ToolGen provide any "explanation as to who extracted the video from the internet and provides no metadata to establish its origins" and ToolGen did not question Dr. Carroll about the video during his deposition.

CVC's basis for its objection to Ex. 1593 was that ToolGen provided the interview "for the truth of the matter asserted," i.e., "CVC inventors' timing, difficulty, challenges, and knowledge relating to their invention of CRISPR-Cas9 in eukaryotes."  This constitutes "double hearsay" according to CVC and should be inadmissible because "it is a third-party's out of court statement recounting a party's out of court statement."  Moreover, CVC argued that "[t]he cited publication is an edited excerpt of a longer interview, as evidenced by bracketed text within Dr. Doudna's responses and other expository remarks."  These revisions were not made to "present a historical account of facts for the purposes of resolving intellectual property rights" CVC asserts but rather "were formulated to 'capture the interest' of the intended audience."  That these are the inventor's out-of-court statements does not rescue them from a hearsay objection according to CVC, citing Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993) and New England Mut. Life Ins. Co. v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989).  Neither does their status as "hearsay within hearsay" make them admissible under the party admission against interest under Fed. R. Evid. 805 according to CVC because "[o]ut-of-court statements that have been curated by a third-party for other purposes are not admissible to prove the sequences of events, the motivations, intentions, and expectations of the inventors," citing SO ¶ 152.2.1.

In its Opposition filed October 8th, ToolGen began its argument my reminding the Board that these are CVC's fact witnesses who are contradicting current positions taken in the interference.  As for the YouTube video (Ex. 1283), ToolGen asserts that CVC objected to only 15 seconds of a 53-minute video, but that in these 15 seconds "Dr. Carroll admits that ToolGen inventor Dr. Jin-Soo Kim discovered what was not obvious to skilled artisans at the time—that adding two guanines to the 5' end of guide RNA improves its specificity."  With regard to CVC's authenticity arguments, ToolGen noted that "the video shows that it was posted by the Innovative Genomics Institute, a company founded by CVC's own Dr. Doudna" (stating later in the Opposition that "CVC is thus challenging the authenticity of a video of its own witness, posted by its inventor's organization").  ToolGen argued further that there were "multiple indicia of authenticity supporting that the video reliably depicts Dr. Carroll and his views."  ToolGen contends that under FRE 901(b)(4), "the appearance, contents, and distinctive characteristics of the video support a finding that the video is what ToolGen claims it is: a lecture by Dr. Dana Carroll," citing Zen Design Grp., Ltd. v. Scholastic, Inc., No. 16-12936, 2019 WL 2996190, at *2 (E.D. Mich. July 9, 2019).  According to ToolGen, "[t]he Innovative Genomics Institute, Dr. Doudna, and Dr. Carroll also have had years to remove this video from YouTube if there were any inaccuracies depicted.  They have not done so."  ToolGen draws the conclusion that:

CVC moves to exclude this evidence only because the video clip directly contradicts CVC's litigation position with respect to obviousness.  Given the totality of the circumstances, the video is authentic and accurately depicts Dr. Carroll admitting that ToolGen was the first to discover that two guanines on the 5' end of the guide RNA improves specificity.

Regarding the Doudna interview, ToolGen argued that even CVC's own exhibits contained articles where Dr. Doudna expresses the same sentiments regarding adapting CRISPR to eukaryotic cells, citing "Ex. 2279 ("We weren't sure if CRISPR/Cas9 would work in eukaryotes[.]"); Ex. 2032 ("Doudna experienced 'many frustrations' getting CRISPR to work in human cells."); Ex. 2033 ("[I]t was not known whether [a CRISPR-Cas9] system would function in eukaryotic cells.")."  These are "multiple indicia of trustworthiness" ToolGen contended; moreover, ToolGen argued that "Dr. Doudna's contemporaneous thoughts are far more probative than Dr. Doudna's testimony prepared for (sic) litigation."  ToolGen contended that Dr. Doudna's own statements were not hearsay under FRE 801(d)(2) because she is a party opponent, citing Nuance Communs., Inc. v. Abbyy Software House, 626 F.3d 1222, 1230 n.1 (Fed. Cir. 2010).  ToolGen also asserted that this interview satisfied FRE 807 as "the residual exception to hearsay" which provides the evidence is not excluded if:

(1) the statement is supported by sufficient guarantees of trustworthiness—after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement; and (2) it is more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts.

(all of which factual predicates are satisfied here, ToolGen argued).  ToolGen asserted three bases for establishing the interview's trustworthiness:  Dr. Doudna herself confirmed the article was written after she was interviewed; the sentiments contained in the interview were ones she had voiced in several other instances; and Dr. Doudna has never corrected or retracted she made in the interview, even in her deposition when given an opportunity to do so.

ToolGen also asserted that this evidence should not be excluded because it is "highly probative of Dr. Doudna's contemporaneous thoughts regarding the doubts she had that CRISPR-Cas9 could be adapted for use in eukaryotic cells," citing United States v. U.S. Gypsum Co., 333 U.S. 364, 395–96 (1948), and the Board's own preference for contemporaneous statements on this very issue in Interference No. 105,048 and in the Decisions on Motions in Interference No. 106,115.

In its October 15th reply, CVC directed its counterargument to ToolGen's "belated" attempt (in its view) to authenticate Dr. Carroll's YouTube video with reference to ToolGen Exhibit Nos. 1614 (the Innovative Genomics Institute website, Innovative Genomics Institute) and 1615 (Opening Screen of Ex. 1283 (Dana Carroll, Issues in CRISPR-Cas Editing, YOUTUBE, 32:42–32:57 (Nov. 4, 2017)).  The time to authenticate was August 5, 2021 (in response to CVC's timely objection) and the Board should not permit ToolGen to supplement its evidence with these attempts to corroborate, CVC argued.  CVC also rebutted ToolGen's argument that only 15 seconds of the Carroll lecture were to be excluded, saying that CVC had move to exclude the video "in its entirety" (emphasis in brief).  Rather, ToolGen submits a video "excerpt" unauthenticated as to "who excerpted it, and whether it still accurately portrays the original subject matter in its excerpted form" (emphasis in brief).

As to the Doudna interview, CVC argued in its Reply that ToolGen's distinction in its Opposition that CVC's Motion did not cite "patent cases" is irrelevant because the rules regarding hearsay do not depend on the subject matter ("Hearsay is hearsay").  And as for ToolGen's invocation of FRE 807, CVC argued that:

Courts have specifically found that mainstream media interviews edited for publication to a lay audience lack the traditional indicia of reliability that Rule 807 requires, because quotes in such publications are cherry-picked to give a sense of drama and "capture the interest of . . . readers, who might otherwise have little interest," rather than to present an accurate or fulsome account of events.

citing New England Mut. Life Ins. Co. v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989), and Ohio v. Roberts, 448 U.S. 56, 65 (1980); Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993).  Moreover, CVC's quotations from Dr. Doudna direct the Board's attention to the number of times that Dr. Doudna did not validate the statements attributed to her, saying frequently "I don't know that to be true" or variants thereof.  Finally, to the extent that ToolGen relied on statements from other sources similar to the ones the interview had Dr. Doudna making CVC argues that those sources may be equally unreliable and cited Gehin v. Wisconsin Group Ins. Bd., 692 N.W.2d 572, ¶ 92 (Wis. 2005), for the principle that "bootstrap[ping] uncorroborated hearsay with uncorroborated hearsay would eviscerate the requirement that there be corroboration of hearsay in order for the hearsay evidence to form the basis of an agency's finding of fact").

The Board will render its decision prior to Final Hearing in this Interference.