PTAB Sets Preliminary Motions in Broad v. ToolGen Interference

By Kevin E. Noonan --

On March 1st, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) issued its Order on the Preliminary Motions Lists submitted by Junior Party The Broad Institute, the Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, "Broad") and Senior Party ToolGen Inc., in Interference No. 106,127.

Broad had requested permission to file seven proposed motions (one of which is Motion No. 7 under 37 C.F.R. § 41.208(a)(4), which seeks judgment based on priority, which was routinely deferred to the Priority Phase of the interference).  Broad Motion No. 1 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) seeks to substitute the Count in this interference with proposed Count 2:

A CRISPR-Cas9 system, for use in a eukaryotic cell, comprising:
    a) a Cas9 or a nucleic acid encoding the Cas9 and
    b) an RNA or a nucleic acid encoding the RNA, wherein the RNA is a dual RNA comprising a CRISPR RNA (crRNA) and a trans activating crRNA (tracrRNA) or wherein the RNA is a chimeric RNA comprising a crRNA fused to a tracrRNA,
    wherein the crRNA directs the Cas9 to a target sequence in a eukaryotic cell, whereby a site-specific, double-strand break is introduced, or the target sequence is edited.

In the alternative, Broad asked that the Board substitute Count 1 for a count that recites both claim 85 of the involved ToolGen application (No. 14/685,510) or claim 1 of Broad Application No. 15/160,710 or claim 74 of Broad Application No. 15/430,260.  The Board GRANTED this motion (BROAD MOTION 1), but limited to proposing a single Count 2.

The Board also GRANTED Broad's Motion No. 2 (contingent) (BROAD MOTION 2) 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) seeking to have claims 1, 40, and 41 of Application No. 15/160,710 and claims 74, 94, and 95 of Application No. 15/430,260 be added to the interference, to the extent these claims have been deemed allowable by the Examiner by the time the motion is filed.

The Board further GRANTED Broad's Motion No. 3 (BROAD MOTION 3) under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(2) to designate certain involved claims as corresponding to neither Count 1 or Proposed Count 2.

The Board DENIED Broad's Motion No. 4 under 37 C.F.R. § 41.121(a)(1)(iii) for judgment that claims of ToolGen's involved application are unpatentable for failure to satisfy the written description and enablement requirements of 35 U.S.C. § 112(a), on the grounds that "the motion will not otherwise further the inquiry into priority of invention of the count."

The Board DEFERRED Broad's Motion No. 5 under 37 C.F.R. § 41.121(a)(1)(iii) for judgment that claims of ToolGen's involved application are unpatentable over the recited prior art under either 35 U.S.C. § 102 or § 103.  The Board said that "[t]he issues raised by this motion are not necessarily dispositive of the priority contest with ToolGen" and that "an interference is not a substitute for other patentability proceedings in the Office or elsewhere."

Finally, the Board ORDERED both parties to provide notice of allowance of claims in related applications, and DISMISSED as moot Broad's request to file Motion No. 6 under 37 C.F.R. §§ 41.121(a)(3) to compel ToolGen to provide such notice.

ToolGen's Motions List contained ten motions including its Motion No. 10 for Judgment on priority basis (which the Board DEFERRED until the priority phase).  The Board DENIED ToolGen's Expedited Miscellaneous Motion No. 1 under 37 C.F.R. §1.645(d) that this interference should be stayed pending Final Judgment in Interference No. 106,115, because this motion is not one "to changing the status quo of the interference as declared in preparation for a priority phase, if one is necessary."

The Board GRANTED ToolGen's Motion No. 2 (hereinafter designated TOOLGEN MOTION 1) under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) that seeks to be granted the priority benefit of U.S. Provisional Application Publication No. 61/837,481, filed June 20, 2013; and PCT Application No. PCT/KR2013/009488, filed October 23, 2013.

The Board also GRANTED ToolGen's Motion No. 3 (hereinafter designated TOOLGEN MOTION 2) under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) attacking the priority benefit granted to Broad on the basis of U.S. Provisional Application No. 61/736,527, filed on December 12, 2012.

The Board DENIED ToolGen's request to file Motion No. 4 under 37 C.F.R. § 41.121(a)(1)(iii), which is for judgment that the involved patents or applications of each Junior Party are unpatentable for failure to satisfy the written description and enablement requirements of 35 U.S.C. § 112(a).  The Board's basis for denying the request is that "[b]ecause Broad is involved in the interference based on patented claims, and ToolGen did not assert that it would raise a threshold issue."  See 37 C.F.R. § 41.201.

ToolGen's Motion No. 5 under 37 C.F.R. § 41.121(a)(1)(iii) is for judgment that the involved patents or applications are unpatentable under 35 U.S.C. § 102(f) for improper inventorship and was DEFERRED by the Board until the priority phase, because "the facts of inventorship may overlap with the facts of priority."

The Board DENIED ToolGen's Motion No. 5 for additional discovery, i.e., the deposition testimony of Dr. Luciano Marraffini, as being premature until the priority phase of the interference has been authorized.

The Board DEFERRED ToolGen's request to file Motion No. 6 that Broad's involved claims were unpatentable over prior art under 35 U.S.C. § 102 and/or § 103, on the grounds that the priority phase of the interference has not been authorized and that "these challenges might be raised in another type of proceeding in the Office or elsewhere."

The Board DENIED ToolGen's Motion No. 7 seeking to argue that Broad's involved claims are unpatentable due to inequitable conduct, on the grounds that this motion is premature and that the issues ToolGen asserts it will raise "may overlap with issues that are raised and decided during a priority phase of the interference."

The Board ORDERED ToolGen, pursuant to its Motion No. 8 for a protective order under 37 C.F.R. § 42.54, to submit a proposed protective order to keep Toolgen's Priority Statement sealed until the priority phase of the interference commences (the request to file Motion No. 6 was dismissed as moot accordingly).  The Board's reasoning set forth in the Order was that "[b]ecause ToolGen is concerned about potentially interfering subject matter by a competitor and in light of our rule allowing priority statements to be maintained in confidence for a limited time, ToolGen's arguments to seal its priority statement has merit."

Finally, the Board DENIED ToolGen's Miscellaneous Motion No. 9 under 37 C.F.R. § 41.104(a) for the Board to order the '126 and '127 Interferences to proceed on the same schedule.  The Board's reasoning is that "ToolGen is free to agree or disagree with proposed changes in the schedule [set forth in the Order] and the Board expects all parties to cooperate on scheduling issues."

The Board refused to waive the requirement 37 C.F.R. § 41.121(d) for statements of material facts in each motion (which count against the page limits for each) but waived the requirement for consecutive exhibit number under Standing Order ¶ 154.2.1.

The Board set out the following briefing schedule, subject to agreement by the parties to change the schedule for TIME PERIODS 1-6:

TIME PERIOD 1 ..............................................................9 April 2021
File motions
File (but serve one business day later) priority statements

TIME PERIOD 2 ..............................................................14 May 2021
File responsive motions to motions filed in TIME PERIOD 1

TIME PERIOD 3 .............................................................25 June 2021
File oppositions to all motions

TIME PERIOD 4 ............................................................6 August 2021
File all replies

TIME PERIOD 5 ......................................................17 September 2021
File request for oral argument
File motions to exclude
File observations

TIME PERIOD 6 ...........................................................8 October 2021
File oppositions to motions to exclude
File response to observations

TIME PERIOD 7 ..........................................................15 October 2021
File replies to oppositions to motions to exclude

DEFAULT ORAL ARGUMENT DATE .................................................. TBD

Comments

[Paul F Morgan]

I wonder if the Fed. Cir. decision in Ono Pharmaceutical Co., Ltd., v. Dana-Farber Cancer Institute, Inc. [pending a cert petition] on who can be a joint inventor [even if their contribution had become public prior art?] will impact these two pending interferences on the very important Nobel Prize winning CRISPR/Cas9 genetic scissors invention?