By Kevin E. Noonan —

On May 28th, Junior Party the Broad Institute, Harvard University and MIT (collectively, "Broad") filed its Contingent Preliminary Motion No. 2 in CRISPR Interference No. 106,126 (where ToolGen is the Senior Party), pursuant to 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Standing Order ("SO") 203.2.  This motion is contingent on the Board's grant of Broad's Substantive Preliminary Motion No. 1.  In that motion, Broad asked the Board to substitute (in part) a new Count No. 2 in place of Count 1 in the '126 Interference as instituted (see "Broad Files Substantive Preliminary Motion No. 1 in CRISPR Interference").

In this motion, Broad asked the Board to add their U.S. Application Nos. 15/160,710 (having allowable claims 1, 40, and 41) and 15/430,260 (allowable claims 74, 94, and 95) to the Interference and designate the allowable claims as corresponding to Proposed Count 2.  Consistent with their arguments in Motion No. 1, Broad contended that these claims recite "generic" limitations with regard to the RNA components of CRISPR, i.e., both dual-molecule and single-molecule guide RNA.  In the alternative (i.e., should the Board deny Broad's Substantive Preliminary Motion No. 1), Broad in this motion asked the Board to designate claim 1 of the '710 application and claim 95 of the '260 application as corresponding to current Count 1.

On August 6th, ToolGen filed its Opposition to Broad's Contingent Preliminary Motion No. 2.  ToolGen first asserts that it has shown (in its Opposition to Broad Preliminary Motion No. 1) that Broad's motion to substitute the Count should be denied (in which case this motion would become moot).  ToolGen also contends that "Broad has neither demonstrated that the claims should be added, nor that alternative remedies are unavailable," also providing a basis for the Board to deny this motion.  ToolGen focuses on Broad's arguments in its motion that "proceeding with Count 1 would be unfair [to Broad]," because (logically) should the Board reach this motion on the merits it would have had to grant Broad Motion No.1 and any "unfairness" would have been resolved ("Count 1 would no longer exist for Broad to complain about").  Some of the basis for this argument is also procedural, to the extent that Broad makes these unfairness arguments in Motion No. 2 they are duplicative of the same arguments in its Motion No. 1.

Substantively, ToolGen argues that Broad has not borne its burden under 37 C.F.R. § 41.208(b) and SO ¶ 203.2 showing why these claims should be added to this Interference and why alternative remedies are unavailing or inadequate.  Instead, according to ToolGen, Broad merely shows how these claims correspond to the "Broad half" of Proposed Count 2.  ToolGen argues:

"One cannot broaden the scope of a count just for the sake of doing so.  Likewise, one cannot simply add claims for the sake of designating more claims without offering a compelling reason" under 37 C.F.R. § 41.208(b) as provided by Louis v. Okada, 59 U.S.P.Q.2d 1073 (B.P.A.I. 2001) (precedential) to the effect that the scope of a count should be changed only when there is a "compelling reason" for doing so.

According to ToolGen, Broad has failed to make a showing of such a compelling reason.

ToolGen also argues the motion is not necessary, because either Broad will prevail under Proposed Count 2 and the claims at issue in this motion will grant, or Broad will not prevail and Broad will be estopped from pursuing them under the principles of interference estoppel.  In neither case, according to ToolGen, will these claims have any effect on the priority determination made in this Interference.

Turning to alternative remedies, ToolGen argues that Broad has not explained why any such remedies would be inadequate, merely relying on its arguments of unfairness.  Alternatives exist, according to ToolGen, but Broad neither acknowledges them nor explains why they would be inadequate.  For example, ToolGen challenges Broad for not satisfying requirement (4) of SO ¶ 203.2, requesting the examiner to declare another interference (which the Board could then combine with this one).  Nor does Broad inform the Board (and ToolGen) if it has taken these steps in ex parte prosecution.

ToolGen also argues that the Board did not authorize what ToolGen characterizes as Broad's "request for relief" of adding claim 41 of the '710 Application and claim 95 of the '260 Application as corresponding to Count 1 should the Board refuse to substitute Proposed Count 2 as Broad requested in its Preliminary Motion No. 1.

Finally, ToolGen contends that Broad's motion exceeds the scope of the Motions List submitted to the Board in this interference because it contends in its motion that claims 40 and 41 of the '710 application and claims 95 and 96 of the '260 application are "generic as to the RNA configuration."  This is not how Broad characterized these claims in its Motions List, ToolGen asserting that Broad characterized all six claims in these two applications as being generic and that the Board relied upon these characterizations. Consequently:

Because the Board relied on Broad's prior characterization (F12), the Board's authorization is also limited to the Broad's initial characterization of the claims as generic.  Broad may not now expand its arguments to urge that claims 40, 41, 94 and 95 are limited to single- or dual-molecule RNA.  In doing so, Broad exceeds the scope of its authorization for Motion 2.  Accordingly, for this additional reason, the Board should dismiss or deny Broad's request to add claims 40, 41, 94 20 and 95.

By Kevin E. Noonan —

On May 28th, Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") filed its Substantive Preliminary Motion No. 3 in CRISPR Interference No. 106,126 (where ToolGen is the Senior Party).  This motion, pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) requested that the Board de-designate Broad claims in these five categories as not corresponding to either Count 1 or proposed Count 2 (A-E) or Count 1 (F):

• Category A: use of vectors for RNA expression;
• Category B: Staphylococcus aureusCas9 protein ("SaCas9");
• Category C: Cas9 chimeric CRISPR enzyme;
• Category D: Cas9 with two or more nuclear localization signals ("NLSs");
• Category E: Cas9 fused to specified protein domains; and
• Category F: Claims not limited to single-molecule RNA.

On August 6th ToolGen filed its Opposition.

In its Motion, Broad asserted that, should the Board grant its motion and deny Broad Substantive Motion No. 1 (see "Broad Files Substantive Preliminary Motion No. 1 in CRISPR Interference") these of the Broad claims would correspond to Count 1:

[C]laim 18 of U.S. Patent No. 8,697,359, claims 26-30 of U.S. Patent No. 8,795,965, claims 2 and 5 of U.S. Patent No. 8,906,616, and claim 16 and 27 of U.S. Patent No. 9,840,713 [exhibit references omitted].

On the other hand, should the Board grant both Broad's Motion No. 3 and Broad's Motion No. 1, these of Broad's claims would remain in the interference as corresponding to Proposed Count 2:

[C]laims 15-20 of the '359 patent, claims 26-29 of U.S. Patent No. 8,771,945, claims 26-30 of the '965 patent, claims 24-30 of U.S. Patent No. 8,889,356, all claims of the '616 patent, claims 21-28 of U.S. Patent No. 8,945,839, and claims 15-17, 20-24, 26-28, 31-35, and 38-39 of the '713 patent, as well as allowable claims 1, 40, and 41 of Application 15/160,710 and allowable claims 74, 94, and 95 of Application 15/430,260 should the Board also grant Broad's Contingent Substantive Motion No. 2 [see "Broad Files Contingent Preliminary Motion No. 2 in CRISPR Interference"; exhibit references omitted].

According to Broad, these five categories comprise claims drawn to "patentably distinct" inventions from the inventions within the scope of either Count 1 or Count 2.  Broad argued that these distinctions are neither disclosed nor obvious in view of the Counts as they would be understood by those having ordinary skill in the art.  Moreover, and consistent with Broad's arguments in this interference and in Interference No. 106,115, Broad contended that dual-molecule and single molecule guide RNA embodiments of CRISPR are also patentably distinct and claims not limited to single-molecule embodiments should be de-designated as not corresponding to Count 1.  Broad's motion then set forth its arguments why claims from each of these categories do not correspond to the Count.

ToolGen's Opposition takes each of these categories and Broad's arguments in turn, after reminding the Board of the similarities between this Motion and Broad's Motion No. 3 in Interference 106,115 (which the Board denied).  With regard to claims directed to use of vectors for RNA expression, ToolGen argues that Broad failed to satisfy the relevant standard under 37 C.F.R. § 41.207(b)(2) that either Count 1 as declared or Count 2 as proposed by Broad (see "Broad Files Substantive Preliminary Motion No. 1 in CRISPR Interference") would not have anticipated nor rendered obvious the "vector claims" Broad now asks the Board to de-designate.  ToolGen maintains in support of this assertion that "a POSA would have been motivated to use vectors in the eukaryotic CRISPR-Cas system of Count 1 or Proposed Count 2 with a reasonable expectation of success" because "as of the priority date, the use of vectors, e.g., plasmid vectors, was well known and widely employed for introducing DNA sequences encoding RNA molecules into eukaryotic cells."  While acknowledging that, as Broad contends, "[d]elivery of RNA components of a CRISPR-Cas9 system can be accomplished in multiple ways," this argument does not refute that vectors are one known way to achieve intracellular sgRNA production because use of vectors for this purpose is "well-known and widely employed" for doing so according to ToolGen.  ToolGen's brief cites the Federal Circuit (Genzyme Corp. v. Transkaryotic Therapies, 346 F.3d 1094, 1099–1100 (Fed Cir. 2003)) and treatises (J.F. SAMBROOK & D.W. RUSSELL, MOLECULAR CLONING: A LABORATORY MANUAL (3d ed. 2001)) to establish the conventionality (and hence reasonable expectation of success) of vector-based introduction methods, and distinguishes Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. 18 Cir. 2008) (cited by Broad), on the grounds that that case (unlike here) was related to a "factually distinct scenario" where there were not a small number of finite options that were available to a skilled artisan.  Finally, ToolGen contends that Broad has not established any of the objective indicia of non-obviousness to support its arguments; this contention relies on ToolGen's argument that Broad failed to establish the required nexus between any of the asserted secondary considerations and the inventive feature of the claims Broad seeks to have de-designated (an argument getting increased traction before the Federal Circuit; see "The Federal Circuit Addresses Commercial Success").

Regarding Broad's challenge to claims reciting Staphylococcus aureus Cas9 protein (SaCas9), ToolGen argues that the skilled worker would have been motivated to use it in the eukaryotic CRISPR-Cas system recited in either alterative Count due to its small size (the advantages of CRISPR embodiments using this Cas9 species being recognized in the prior art according to ToolGen) and that the nucleotide sequence encoding it was known in the art.  In addition, ToolGen argues that the skilled worker would have been motivated to use SaCas9 in adeno-associated virus (AAV) vectors due to their being "available and commonly used in the art—particularly for 'human therapeutics'" due to their lack of pathology to humans and their capacity for "long-term gene expression."  ToolGen challenges Broad's factual assertions that there were many Cas9 analogs known in the art at the priority date and that the skilled artisan would have had no basis for choosing to use SaCas9.  ToolGen asserts that Broad was incorrect in arguing that SpCas9 was the predominant Cas9 species used in prokaryotes and that there was no reason for a POS to switch to SaCas9, nor that there were a plethora of smaller-sized Cas9 proteins to choose from as well as Broad's arguments with regard to amino acid sequence differences between SpCas9 and SaCas9.  As with the vector claims, and for many of the same reasons, ToolGen argues that Broad has not established any of the asserted secondary considerations, particularly with regard to unexpected results.

Next, ToolGen's brief turns to claims reciting the use of chimeric Cas9 species, against which ToolGen first argues waiver, based on the paucity of the support ToolGen alleges Broad submitted regarding this argument, citing Oracle Am., Inc. v. Google Inc., 750 F.3d 1339, 1377 n.17 (Fed. Cir. 2014).  Nevertheless, ToolGen walks through its argument that a POSA would have been motivated to use chimeric SaCas9 proteins, due to the "vast array of prior-art references disclosing the use and numerous benefits of chimeric proteins."  And again, ToolGen argues Broad failed to establish any of the objective indicia, particularly unexpected results, asserting that "a POSA would have expected a chimeric Cas9 protein to have altered results in areas such as specificity and the ability to target specific PAM sequences, which are the exact results Broad claims to be 'unexpected'" (emphasis in brief).

Further, with regard to Broad's arguments involving use of two nuclear localization signals (NLS) to target SaCas9 to the eukaryotic cell nucleus, ToolGen argues the skilled worker would have been motivated to use two or more NLSs with Cas9 to make CRISPR-Cas9 complexes in eukaryotic cells, with a reasonable expectation of success.  Use of NLS sequences was routine in the art prior to the priority date ToolGen asserts, citing teachings in the art regarding "Type I and III CRISPR systems, and [with regard to] proteins of Zinc Finger Nucleases, TALENs, Rec A, Lac, and HaloTagTM proteins."  Moreover, ToolGen maintains that before the priority date "several well-known and readily available commercial eukaryotic expression vectors attached two or more NLSs to proteins expressed from the vector."  And again ToolGen argues Broad has not established the existence of any objective indicia of non-obvious.

ToolGen also sets forth its arguments in contradiction to Broad's arguments that "Cas9 fused to specified protein domains or including heterologous domains" correspond to either of the alternative Counts.  Again, ToolGen maintains that Broad had waived this argument by the paucity of evidence or argument Broad asserts in support thereof, and more substantively, that the skilled worker would have understood Cas9 species joined with one or more NLS to be "fused" (and thus known in the art).  ToolGen reiterates earlier arguments that "generating protein fusions had been used for decades before the priority date as a method of purifying proteins, and fusing green fluorescent protein (GFP) to proteins was also used as a method of detecting protein localization in prokaryotic and eukaryotic cells."  And ToolGen again recited Broad's failure to establish any of the objective indicia of non-obviousness.

ToolGen then turns to Broad's arguments that certain of its claims having been designating as corresponding to Count 1 do not recite single-guide RNA (sgRNA) with regard to "three sets of claims":

(1) those "that do not require an RNA component at all";

(2) those "that are generic as to the RNA component and do not use the term 'guide RNA'"; and

(3) those "that are generic as to the RNA component and that use the term 'guide RNA.'"

ToolGen's argument is that by their own specifications Broad's patents-in-interference rebut this argument, citing in particular U.S. Patent No. 8,697,359 for the teachings that:

In aspects of the invention the terms "chimeric RNA", "chimeric guide RNA", "guide RNA", "single guide RNA" and "synthetic guide RNA" are used interchangeably and refer to the polynucleotide sequence comprising the guide sequence, the tracr sequence and the tracr mate sequence [emphasis on brief].

ToolGen also notes that their argument is consistent with the Board's determination in the '115 Interference, based on the principle that "where 'a patent applicant has elected to be a lexicographer by providing an explicit definition in the specification for a claim term, . . . the definition selected by the patent applicant controls,'" citing Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).  The specification provides an "explicit, clear, and unambiguous definition" that "makes it unnecessary to resort to weak inferences from cherry-picked claims" to rebut it, ToolGen asserts in response to Broad's attempted recourse (as in the '115 Interference) to claim differentiation arguments.  ToolGen maintains that this equivalence in language in the specification is consistently used throughout Broad's  patents-in-interference and cannot be disclaimed here in an attempt to distinguish the claims Broad argues the Board should de-designate as corresponding to either Count.  ToolGen also maintains that the term "guide RNA" does not have a "plain and ordinary meaning" in the art (paradoxically illustrated ToolGen asserts by the references Broad cites in support of its arguments) and thus Broad's express definition should be conclusive as to the construction of the term given by the Board.

Finally, and particularly with regard to claims 15, 17–26, and 28–41 of the '713 patent and claims 1–24 of the '418 patent, ToolGen argues that the species recited in Count 1 anticipates these generic claims under 37 C.F.R. § 41.207(b)(2) (as the Board held in the '115 Interference) and In re Slayter, 276 F.2d 408, 411 23 (C.C.P.A. 1960).

For all these reasons ToolGen asks the Board to deny Broad's Substantive Preliminary Motion No. 3.

By Kevin E. Noonan —

On May 28th, Junior Party the Broad Institute, Harvard University, and MIT (collectively, "Broad") filed its Substantive Preliminary Motion No. 1 in CRISPR Interference No. 106,126, where ToolGen is the Senior Party.  This Motion shared many similarities to a similar motion filed in Broad's Interference No. 106,115 against the University of California, Berkeley, the University of Vienna, and Emmanuelle Charpentier; Junior Party and collectively, "CVC"), but there were significant differences in the proposed Count 2 in this interference and the proposed Count 2 proposed in the '115 Interference (wherein the Board denied Broad's motion in that interference).  On August 6th ToolGen filed its Opposition.

Broad filed this motion pursuant to 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1).  The two proposed Counts 2 are set forth as follows:

Broad's argument, which was unsuccessfully in the '115 interference, was that it would be unfair to preclude them from establishing conception of the "genus" of eukaryotic CRISPR claims by limiting the Count to sgRNA species (which here, as in the '115 interference, would be subject to arguments of prior conception), an argument the motion asserts is "consistent with Broad's proofs in [the '115 interference]" (see "CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 2").

ToolGen argues that the Board should deny Broad's motion first, because Broad has neither established nor argued that dual-and single-molecule eukaryotic CRISPR is the same patentable invention, and second, that Broad's proposed Count 2 "does not define the common claimed subject matter [because] all of ToolGen's involved claims are limited to single-molecule RNA" species (emphasis in brief).  The first deficiency ToolGen asserts for Broad's first argument is that Broad's assertion that the two configurations are "analogous approaches" to eukaryotic CRISPR is not the same as arguing (which ToolGen notes Broad does not do) that they are the same invention.  This makes Broad's motion "doomed at the threshold," according to ToolGen and the cases Broad cites for broadening the scope of the Count — including Grose v. Plank, 6 15 U.S.P.Q.2d (BNA) 1338, 1342, (B.P.A.I. March 23, 1990), and Kondo v. Martel, 220 7 U.S.P.Q. (BNA) 47, 49 (B.P.A.I. May 2, 1983), are inconsistent with cases mandating that a Count cannot be "broadened to such an extent as to include another, separately patentable invention," citing Theeuwes v. Bogentoft, 2 U.S.P.Q.2d (BNA) 10 1378, 1379 (Comm'r Pat. & Trademarks December 11, 1986), and Lee v. McIntyre, 55 U.S.P.Q.2d 1137, 1142 (B.P.A.I. 2000).  Under these circumstances, ToolGen argues Broad has not satisfied its burden to show it is entitled to the relief requested under 37 C.F.R. § 41.121(b) and SO 121.3.  In this regard, ToolGen asserts the standard that a dual-molecule eukaryotic CRISPR system would be prima facie obvious over single-molecule embodiments, under Spine v. Biedermann Motech GmbH, 684 F. 18 Supp. 2d 68, 89 (D.D.C. 2010).  "Highly analogous" is not the standard ToolGen (correctly) maintains, yet that is the limit of Broad's argument in its motion.  ToolGen then explicates the deficiencies in Broad's evidence (comprising expert testimony) in the motion in support of the relief of changing the Count, including that it comprises mostly attorney argument, citing Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1068 (Fed. Cir. 2005); Elbit Sys. of Am., LLC v. Thales Visionix, Inc., 881 F.3d 1354, 15 1359 (Fed. Cir. 2018); and In re Gorniak, No. 90-1510, 1991 U.S. App. LEXIS 2741, at *3 (Fed. Cir. 16 Feb. 20, 1991).  Anticipating Broad's response, ToolGen reminds the Board that "Broad cannot attempt to make that showing for the first time in its reply," citing Nau v. Ohuchida, Int. No. 104,258, 9 Paper 57, at *4 (B.P.A.I. 1999).

Turning to its second basis for Opposition, ToolGen argues that contrary to Broad's arguments, proposed Count 2 is broader than the common claimed invention between the parties because, as instituted by the Board, existing Count 1 is limited to single-molecule RNA embodiments of eukaryotic CRISPR and that common claimed subject matter is what defines an interference, citing Beech Aircraft Corp. v. Edo Corp., 990 F.2d 1237, 1248–49, and Louis v. Okada, 59 22 U.S.P.Q.2d 1073, 2001 WL 775529 at*4 (B.P.A.I. 2001).  ToolGen asserts (factually) that its claims corresponding to Count 1 are limited to single-molecule RNA eukaryotic CRISPR embodiments (which ToolGen maintains Broad admitted when it characterized ToolGen's claims as comprising "both dual- and single-molecule RNA configurations of CRISPR-Cas9 before amending to only the single-molecule approach currently claimed in their involved patent application" (emphasis in brief).  That its initially filed claims comprised both single- and dual-molecule embodiments is irrelevant according to ToolGen's brief because the interference as declared was limited to ToolGen's single-molecule embodiments.

ToolGen then turns to Broad's "best proofs" arguments.  To this, ToolGen replies that Broad's Motion does not establish or identify its best proofs sufficiently for the Board to properly assess this argument and that regardless Broad's proposed Count 2 improperly "adds and removes elements" of the current Count.  As for Broad's deficiencies in establishing its best proofs, ToolGen cites the Board's decision in Interference No 105,048 that it is proper to broaden a Count "only i[f] there is a compelling reason to do so" and that "[a]rguments that a moving party's best or earliest proofs are outside the scope of the existing count are ordinarily not compelling by themselves."  Regents of Univ. of Cal. v. Broad Inst., Interference 106,115, Decision on Motions, 6 Paper 877, *33 (P.T.A.B. Sept. 10, 2020).  Rather, the standard according to ToolGen is that a party moving to substitute a Count in an interference is that the party "(1) should make a proffer of the party's best proofs, (2) show that such best proofs indeed lie outside of the scope of the current count, and (3) further show that the proposed new count is not excessively broad with respect to what the party needs for its best proofs" citing Louis v. Okada.  ToolGen's brief then sets forth with specificity its arguments regarding how Broad failed to satisfy these requirements, including inter alia failure to proffer testimony (that could be subject to cross-examination) from fact witnesses including Broad inventor Zhang.  What evidence there is proffered regarding Dr. Zhang's work is unsubstantiated hearsay or factually deficient according to ToolGen.  In this regard, ToolGen provides this synopsis of Broad's purported failures under the first prong of Louis:

In summary, Broad has not met its burden of supporting its motion with "appropriate 5 evidence."  37 C.F.R. § 41.208(b).  Broad fails to provide sufficient information to evaluate whether its "best proofs" merit expansion of the count.  Byrn v. Aronhime, Int. No. 105,384, Paper 64, at 11 (B.P.A.I. Sept. 20, 2006).  The proofs that Broad relies upon do not even suggest, let alone prove, that Broad conducted dual-guide experiments before it conducted any single-guide experiments, or that it reduced to practice every element of the proposed count.

Turning to prong 2 of the Louis test, ToolGen argues that Broad's own admissions vitiate Broad's arguments regarding its best proofs falling outside Count 1 of the '126 Interference as declared.  These included a declaration Broad submitted during ex parte prosecution, which included the statement that the inventors had an "appreciation that a single RNA can be used as a guide in the CRISPR-Cas system, including as shown by the RNA used in the experiment of the below figure entitled 'CRISPR NTF3 Surveyor . . . .'"  ToolGen also contends that such statements and positions taken during ex parte prosecution should raise an estoppel (judicial) against Broad from making such arguments in this interference, if only because such statements and positions, according to ToolGen, permitted Broad to get claims encompassing single-molecule RNA embodiments of eukaryotic CRISPR, citing Zedner v. United States, 547 U.S. 489, 504 (2006), as applied to agency adjudications, citing Trustees in Bankr. of N. Am. Rubber Thread Co. v. United States, 593 F.3d 1346, 1354 (Fed. Cir. 2010).

Finally in this regard, ToolGen argues that Broad's Proposed Substitute Count No. 2 is overbroad and would "eliminate significant limitations on the current count" (specifically the limitation that "expression of at least one gene product is altered" (emphasis in brief).

ToolGen then turns to Broad's argument that the Board could grant Broad's Preliminary Motion No. 1 or designate claims that are not explicitly limited to single-molecule RNA embodiments of eukaryotic CRISPR to not correspond to the Count.  "A determination that single-molecule RNA eukaryotic CRISPR systems are separately patentable from dual-molecule RNA systems is fatal to Proposed Count 2, because a count cannot include two separately patentable inventions" according to ToolGen's Opposition.  (ToolGen notes that Broad made similar arguments in the '115 Interference and the Board rejected them.)

Finally, ToolGen argues that Broad failed to bear its burden to show that the new Count is unpatentable over the prior art.  ToolGen expressly requests that the Board reject Broad's argument that the Board's decision in the '048 Interference supports Broad's arguments based on differences in claim scope.

The brief ends with ToolGen's challenge to Broad's assertion of five sets of its claims that do not correspond to Proposed Count 2.  ToolGen contends that Broad has not met its burden of showing that Proposed Count 2 would not have anticipated nor rendered obvious the claims at issue, under 37 C.F.R. § 41.207(b)(2), 37 C.F.R. §§ 41.121(b) and 41.208(b), and providing reasons therefor with regard to the use of vectors for RNA expression, Streptococcus aureus Cas9 protein, chimeric Cas9 species (including fusion with heterologous protein domains), and two or more nuclear localization signals in eukaryotic embodiments of CRISPR.

By Kevin E. Noonan —

On May 20th, ToolGen filed its Substantive Motion No. 1 for benefit of priority in Interference No. 106,126, which names ToolGen as Senior Party and as Junior Party The Broad Institute, the Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, "Broad").  On August 6th, Broad filed its Opposition to this Motion.

As set forth in ToolGen's motion, the Board had granted ToolGen the benefit of its U.S. provisional application, Serial No. 61/717,324, filed October 23, 2012 ("P1"), resulting in ToolGen having an earlier priority date than Broad.  ToolGen submitted this motion to be accorded benefit of priority to two later-filed, related applications:  U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen 5 P3"), or alternatively, International Application No. PCT/KR2013/009488, filed Oct. 23, 2013 ("PCT").  In its motion, ToolGen explains that it is submitting this motion contingent on the Board granting CVC's Substantive Motion No. 2, which attacks ToolGen's entitlement to priority to the P1 priority document in Interference No. 106,127.  The brief sets out graphically the relationship of these priority documents:

The brief then sets out the basis for ToolGen's claim of priority, setting forth its arguments for satisfaction of the written description and enablement requirements under 35 U.S.C. § 112(a) with regard to two embodiments falling within the scope of the Interference Count.

In its Opposition, Broad asks the Board to defer consideration of ToolGen's Motion, properly pointing out that Broad (unlike CVC in the '127 Interference) has not challenged ToolGen's benefit of priority to its P1 provisional application.  Accordingly, Broad asserts that ToolGen's motion is premature and "completely irrelevant" at this time.  Broad further asserts that this motion may "potentially" become relevant "only if multiple contingencies in this and other proceedings—that may or may not ever come to pass—do actually arise."  These include that:

1) the PTAB finds ToolGen is not entitled to the benefit of its P1 application in the co-pending 127 Interference,

2) Broad requests and is granted permission to file a motion here challenging ToolGen's benefit to P1 on the basis of estoppel from that determination in the 127 Interference, and

3) the PTAB grants Broad's motion, depriving ToolGen here of benefit of its P1.

Broad's justification includes that the Board considering this motion under these circumstances would be "waste of judicial resources" as well as improperly constituting an advisory opinion.  The interference rules provide that the Board has discretion to defer consideration of motions under 37 C.F.R. § 41.125 as applied in Berman v. Housey, 291 F.3d 1345, 1352 (Fed. Cir. 2002).  Broad urges the Board to exercise that discretion with regard to ToolGen's Preliminary Motion No. 1.

Broad's brief explicates in further detail the contingent nature of the circumstances needing to arise for ToolGen's motion to be timely, in support of its opposition and request for the Board to defer consideration thereof.

One notable feature of Broad's argument is that good portions of it are redacted.  As set forth in associated Motion to permit portions to be redacted, Broad explains that these portions are to be kept confidential at ToolGen's behest and to protect ToolGen's proprietary information obtained from ToolGen's Priority Statement.  According to Broad in its motion to seal, the redacted portions of its Opposition, "Toolgen alleges that the potential harm to the holders of the information would be significant."  Broad's motion to permit redactions, an unusual request and one even less frequently granted under the Rule that proceedings should be open to the public in the public interest, 37 C.F.R. § 42.14, is (understandably) unopposed by ToolGen in view of the benefit it asserts it requires in Broad's unopposed motion and is based on ¶ 4(a)(ii) of the Protective Order entered by the Board in this interference.  Broad also assures the Board that the redactions have been "narrowly tailored" to "minimize the impact on the public."  In this motion, Broad makes the necessary averments, specifically: 1) The information sought to be sealed is truly confidential; 2) A concrete harm would result upon public disclosure; 3) The information is not necessary to understand the issues; and 4) Confidentiality interests outweigh any interest in access.

Nevertheless, even with the redactions, it can be ascertained that Broad argues that priority to either of ToolGen's U.S. Provisional Application No. 61/837,481, filed June 20, 2013 ("P3" or "ToolGen P3"), or alternatively, International Application No. PCT/KR2013/009488, filed Oct. 23, 2013 ("PCT") would never be relevant because "ToolGen will be unable to beat Broad's dates of [conception and reduction to practice]" if Broad is granted priority in the '115 Interference.  This argument also sounds in representations made by ToolGen during prosecution regarding what was needed to provide a skilled worker with a reasonable expectation of success:

Rather, the only thing that would have alleviated the unpredictability in the art and allayed the concerns of one of ordinary skill at this time would have been the actual demonstration of a Type II Cas9 system successfully introducing site-specific double-stranded breaks in a target nucleic acid sequence within a eukaryotic, e.g., mammalian, cell . . . . [emphasis in brief]

Here, Broad resurrects an argument made in Interference No. 106,115, that eukaryotic CRISPR is an invention for which conception can only be shown by successful reduction to practice (under a theory of "simultaneous conception and reduction to practice" first enunciated thirty years ago with regard to conception of a nucleic acid encoding a particular protein; see, Amgen v. Chugai, Fed. Cir. 1990).

The contingent nature of the events that must arise for ToolGen's Preliminary Motion No. 1 to require the Board to address it, and the intervening determinations that would make this motion moot, according to Broad, provide the basis for Broad's opposition to ToolGen's Preliminary Motion.