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 a 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.