On October 1st, Senior Party ToolGen Inc. filed its Motion to Exclude certain evidence presented by Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") in Interference No. 106,126.  Broad filed its Opposition to ToolGen's motion on October 8th, and ToolGen filed its Reply on October 15th.

ToolGen's bases for excluding evidence including Broad's purported "best proofs" on priority were that they have not been authenticated and are thus inadmissible under FRE 901.  Specifically, ToolGen raised these objections against Broad Exhibits 2526, 2530, 2533, 2535, 2536, 2563, 2565, 2566, 2581, 2582, and 2599.  Some of these objections involve the date of the exhibit (e.g., Exh. 2526) which is dated after the relevant time period concerning conception and reduction to practice of the claimed invention (i.e., CRISPR achieved in eukaryotic cells).  Others relate to lack of "dates, labels, or other identifying marks" (e.g., Exh. 2530, which purports to be "an image of an electrophoresis gel that Broad alleges shows a dual-molecule RNA configuration that was 'used to target, cleave, and edit an endogenous "NTF3" genomic target in eukaryotic cells in October–November 2011'").  ToolGen raised objections on similar grounds against Exhs. 2535, 2536, and 2563, which ToolGen asserted "are unannotated images completely devoid of identifying features" that "could be generic images from anywhere; none contain labels, captions, or descriptions that would allow a person of ordinary skill in the art ('POSA') to understand the alleged experiment, let alone assess whether the exhibit is what Broad claims it to be" (which are "successful single and dual-molecule systems").  Finally, ToolGen asserted that none of these exhibits were authenticated by Broad's expert witness, Dr. Seeger who "[did] not profess to have any knowledge of the aforementioned exhibits."

ToolGen's second basis for its Motion to Exclude is related to Exhibit Nos. 2708, 2710, 2716, 2734, 2751, 2770, 2771, 2772, 2773, 2775, 2777, 2780, 2781, 2782, 2784, 2829, 2830, 2842, and 2845, introduced in support of Broad's Substantive Motion No. 1, and also Exhibit Nos. 2704, 2705, and 2793 introduced in support of Broad's Substantive Preliminary Motion No. 3, and was that they were hearsay and inadmissible under FRE 801 and 802.  These Exhibits all contain out-of-court statements offered for the truth of the matter asserted, specifically "to prove that Broad's experiments allegedly showed successful reduction to practice of Broad's Proposed Count 2."

ToolGen's third ground for its Motion to Exclude is related to Exhibits published after December 12, 2012, as being irrelevant under FRE 401 and 403 for not providing information about the state of the art at the time the application was filed.  In particular, Exh. 2217, relied upon by Broad expert Dr. Seeger and allegedly pertaining to the definition of guide RNA, was relied upon in opining on obviousness and thus should be excluded ToolGen maintained.  ToolGen raised similar objections against Exhibits 2201, 2226, 2231, 2232, 2654, and 2683 (for the relationship as independent inventions between SaCas9 and chimeric Cas-9) and Exhibits 2226, 2231, 2232, 2454, 2683, and 2653.

ToolGen further objected to "certain testimony of Broad's expert Dr. Seeger (i.e., Ex. 2454, ¶¶166–168, 233–243, 255–57) under FRE 702 and 703" as being irrelevant under FRE 403 and improper under FRE 702 and 703.  The latter objection was based on ToolGen's assertions that the evidence is based on "inadmissible exhibits of the type upon which an expert would not ordinarily [or reasonably] rely."  ToolGen made a similar objection to the declaration of Broad's expert, Dr. Seeger (Exh. 2454) as it has on other exhibits, that it (and they) relies on evidence dated after the relevant time period (the dates of the priority applications in the interference).  This disjuncture in time period makes the expert's analysis run afoul of FRE 702 and 703 to the extent that the expert opined on the understanding of one skilled in the art using evidence from post-filing exhibits ToolGen asserts, citing as an example Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008).  These same principles apply here, ToolGen contended, with regard to the expert's assessment of the disclosure of Broad's P1 priority application (61/736,527, filed December 12, 2012) and the meaning to be ascribed to the term "guide RNA," during which the expert relied on Exh. 2217 which post-dates this filing date.  ToolGen cited additional instances of this improper reliance, and asked that the Board exclude the expert's testimony tainted thereby.

ToolGen also criticized Dr. Seeger for relying on "unauthenticated and hearsay[-containing]" exhibits, specifically Exh. 2526 regarding Broad Inventor Zhang's completion of a tracrRNA vector which is "devoid of any identifying features" and is "unsponsored by any witness with personal knowledge."

Finally, ToolGen asserted as hearsay several e-mails (Exh. 2704, 2705, 2708, 2750, and 2793) relied upon by Dr. Seeger in his declaration (Exh. 2454). Because "[e]ach of the . . . emails consists of out-of-court statements offered for the supposed truth of the matter asserted—[that] Broad's experiments allegedly showing successful reduction to practice of dual-molecule CRISPR-Cas9 in a eukaryotic system and that certain claims are separately patentable inventions," ToolGen contended that these e-mails are hearsay and Dr. Seeger's reliance on them should be excluded under FRE 801 and 802.

In its Opposition Broad argued generally that the evidence ToolGen objected to regarding FRE 901 was merely a proffer ("a demonstration of what Broad later intends to prove at the priority phase should the Count be changed") and should not be excluded (because a tribunal can consider such evidence within its sound discretion).  Broad asserted that:

ToolGen's motion is based on a misunderstanding of what it means to make a proffer in connection with a motion to change the count.  The PTAB is clear that—consistent with traditional procedure—a proffer in connection with a motion to change the count need not be based on admissible evidence, as it is not an attempt to introduce testimony or documents.  Rather, a proffer is a demonstration of what a party intends to show at a later point, and thus, it may include unauthenticated or hearsay evidence.  To hold otherwise would require a party making a proffer of its best proofs essentially to put forth its priority case, including subjecting authenticating and testifying witnesses to cross-examination before the priority phase.  This is not consistent with the law or PTAB practice: "[i]n general submission of a document together with a representation by counsel of what the document shows is a sufficient proffer," citing Byrn v. Aronhime, Patent Interference 105,384 (McK), Paper 64, at 11:24-26 (P.T.A.B. Sept. 20, 2006).

Failing that, Broad argued substantively that ToolGen has not met its burden to show inadmissibility under FRE 901(b)(4) because the test for authentication is that indicia thereof ("appearance, contents, substance, internal patterns, or other distinctive characteristics") should be considered as a whole.  And with regard to ToolGen's hearsay arguments Broad countered by contending that ToolGen was wrong because the challenged documents are "not offered for the truth of the matters asserted, but rather as proof of what they say."

Regarding ToolGen's relevancy contentions, Broad argued that "Federal Circuit precedent is clear that post-filing information, such as testing that shows unexpected results or evidence of commercial success, can be relevant" (which is certainly true but is much less clear that Broad addressed the application of the rule advanced by ToolGen), citing Knoll Pharm. Co., Inc. v. Teva Pharm. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004), and Sanofi-Aventis Deutschland GmbH v. Glenmark Pharm. Inc., USA, 748 F.3d 1354, 1360 (Fed. Cir. 2014), as examples (but perhaps because circumstances like commercial success by their very nature must be evidence "after the fact" of conception and reduction to practice of the invention).

Finally, Broad argued that the declaration of its expert, Dr Seeger, is admissible and faults ToolGen for failing to depose him.  Broad also argued that the predicate for ToolGen's objection to Dr. Seeger's declaration, the admissibility of evidence he relied upon based on ToolGen's relevancy and hearsay objections, dooms its arguments that Dr. Seeger's declaration is not admissible.  Even if this is not the case, Broad reminds the panel that "it is well established that an expert can rely on inadmissible or hearsay evidence if it is the type of material on which experts would reasonably rely," citing FRE 703.

The remainder of Broad's Opposition is a point-by-point refutation, by page and line number according to interference rules, of ToolGen's allegations and assertions in its Motion.

In its Reply, ToolGen responds to Broad's allegations that it misunderstands the nature of a proffer by arguing that, regardless of the standard for the Board to consider evidence in a proffer a proponent of the proffer "must show sufficiency of its proffer in its substantive Motion 1, not here" (i.e., not in its Opposition to ToolGen's motion to exclude) and "Broad may not offer evidence into the record under the guise of a proffer, thereby bypassing the evidentiary rules."  ToolGen notes that Broad's expert, Dr. Seeger, had not cited nor described ten of the objected-to citations.

ToolGen also maintains that Broad "misunderstands" how its hearsay evidence is used and is thus is properly deemed to be inadmissible when, as here, it is being introduced as evidence. ToolGen notes that "[b]elying its position, Broad offers the content of challenged hearsay exhibits as material facts in Broad Motion 1," which suggests that this evidence is being used to establish its truth (and not as "proof of what they say"), citing examples of this type of use ("stating as a fact that Zhang 'engineered and tested dual-molecule RNA CRISPR systems in eukaryotic cells'").

With regard to Dr. Seeger's declaration, ToolGen maintains that what is improper, and properly the subject of its Motion to Exclude, is the use of post-filing exhibits to support his averments.  This is because this evidence "provide[s] no insight into how a skilled artisan would understand claim terms at the relevant filing date (emphasis in brief), providing examples and citing Brookhill-Wilk, LLC. v. Intuitive Surgical, Inc., 334 F.3d 1294, 1299 (Fed. Cir. 2003).

And finally, ToolGen characterizes Dr. Seeger's declaration as being a "mere conduit for hearsay" and inadmissible for that reason.  ToolGen admits that FRE 703 permits an expert to rely on the hearsay comprising Exhibits 2704, 2705, 2708, 2750, and 2793, but ToolGen maintains "FRE 703 does not permit an expert or party to evade hearsay rules by simply incorporating inadmissible out-of-court statements into the record via the expert's testimony," citing Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366, 1375 (Fed. Cir. 2021).  ToolGen asserts that "Dr. Seeger does exactly this" by summarizing the contents of various exhibits comprising such hearsay.

The Board will render its decision prior to Final Hearing in this Interference.  Broad has not filed a motion to exclude evidence in this interference.