By Kevin E. Noonan --
Senior Party Toolgen and Junior Parties The Broad Institute, Massachusetts Institute of Technology, and Harvard University (collectively, "Broad") in Interference No. 106,126 and University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") in Interference No. 106,127, each filed Lists of Proposed Motions that the Board considered last week and responsive thereto will issue its rulings shortly (see "The CRISPR Chronicles: Enter Toolgen"). The Toolgen lists have sufficient similarities that they will be the subject of this post, with the individual Junior Parties' lists being the subject of later posts.
As a reminder, an interference proceeds in two stages. The first stage involves the parties presenting motions that can modify the count, have certain claims declared outside the scope of the count (or vice versa), seek to establish an earlier priority date, and ask for a finding that their opponents' claims are invalid under any of the provisions of the patent statute. If these motions are not decided in a way that would disqualify one or both parties, then the interference will move to a second stage, where in each Interference the Junior Party (Broad, in the '126 Interference and CVC in the '127 Interference) will present its proofs of conception and reduction to practice and the Senior Party Toolgen will be permitted to oppose and/or present its own priority evidence. The Senior Party is under no obligation to present proofs earlier than its earliest filing date unless the Junior Party evinces evidence of (at least) earlier conception. In practice, the parties can both be expected to submit their priority evidence.
As might be expected, there are several similarities in Toolgen's lists for each Interference. Toolgen's Motion No. 1 is the same on each list. It requests the Board's permission to file an expedited miscellaneous motion under 37 C.F.R. §1.645(d)* asking the Board to stay the '126 Interference (as well as the '127 Interference) until the Federal Circuit rules on any appeal of the Board's Final Judgment in Interference No. 106,115 now pending between Broad as Senior Party and CVC as Junior Party. In the alternative, Toolgen asks for the stay to extend until after Final Board Decision if there is no appeal. The basis is that such a stay will "promote efficient and fair resolution of the pending interferences," upon which grounds it is within the Board's discretion to grant. In addition, the Board's decision in the '115 Interference may result in "cancellation of all of Broad's or CVC's claims, or a combination," which would "narrow the issues for this and the '127 Interference." This argument is based on the Board having declared this interference (and the '127 Interference) having as a Count the same Claim 18 of Broad's U.S. Patent No. 8,697,359 as in the '115 Interference Count, and having each claim involved in this (and the'127) interference also being involved in the '115 Interference. Toolgen also notes that "in both interferences, parties are challenging Broad's involved claims under Section 102(f) for improper inventorship, for which briefing already is underway in the 115 Interference" and "the briefing, discovery and priority proofs in the 115 Interference will clarify the priority dispute in this proceeding." That earlier Interference should be concluded well in advance of this one, providing further basis for granting the motion. Toolgen asks the Board to set a briefing schedule for a total of five weeks, and to set Time Period No. 1 (when all other motions briefs are due) for no less than six weeks after this motion is decided.
Toolgen's Motion No. 2 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) is also the same on each list, and Toolgen seeks to be granted the priority benefit of U.S. Provisional Application Publication No. 61/837,481, filed June 20, 2013; and PCT Application KR2013/009488, filed October 23, 2013. These are "interior" priorities arising after the earliest filed provisional application and before the pending application upon which this Interference (and the '127 Interference) was declared.
Toolgen's Motion No. 3 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) is a motion to attack accorded benefit. In the '126 Interference against Junior Party Broad, the motion is directed to benefit of Provisional Application No. 61/736,527, filed on December 12, 2012. In the '127 Interference against Junior Party CVC, the motion is directed to Provisional Application No. 61/757,640, filed on January 28, 2013.
Toolgen's Motion No. 4 under 37 C.F.R. § 41.121(a)(1)(iii) 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 basis in each case is that the patents and applications "do not enable one of ordinary skill in the art to practice the use of CRISPR-Cas technology in all types of eukaryotic cells without undue experimentation."
Toolgen's Motion No. 5 in the '127 Interference and Motion No. 7 in the '126 Interference 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 or § 103. In the '126 Interference, the grounds for this motion are that CVC's involved claims in all the patents or application in interference are anticipated or obvious over U.S. Application Publication No. 2016/0298138 assigned to Sigma-Aldrich Co. LLC, and/or U.S. Application Publication No. 2015/0322457 assigned to ToolGen, as well as additional references set forth in an Appendix to this paper. In Motion No. 5 in the '126 Interference, Toolgen contends that Broad's involved claims in all the patents or applications in interference are anticipated or obvious over Cong et al., "Multiplex Genome Engineering Using CRISPR/Cas Systems," Science 339: 819-23 (February 2013; published online January 2013), and/or Mali et al., "RNA-Guided Human Genome Engineering Via Cas9," Science 339: 823-26 (February 2013; published online January 2013), as well as additional references set forth in an Appendix. In both motions, Toolgen asks the Board to relax the 25-page limit to permit them to explain how each of the involved claims recited in the motion are unpatentable.
The lists then vary considerably between the Interferences. In the '126 Interference, Motion No. 5 under 37 C.F.R. § 41.121(a)(1)(iii) is for judgment that Broad's patent and applications in interference are unpatentable for improper inventorship under 35 U.S.C. § 102(f) (pre-AIA) or 35 U.S.C. § 115(a) (post-AIA). The basis for this motion is the record of proceedings involving Broad's European Patent No. EP 2771468, which include a declaration from Broad's attorney Thomas Kowalski, who testified as to inventorship in that application. According to Toolgen, "[a] number of the alleged inventive contributions detailed in the Kowalski Declaration are applicable not only to the PCT Applications**, but also to the Broad claims involved in this interference." Accordingly, Toolgen requests leave to file a motion of unpatentability due to these alleged deficiencies.
Toolgen's Motion No. 6 in the '126 Interference under 37 C.F.R. 41.150(c) is for additional discovery, specifically with regard to Dr. Luciano Marraffini. The Board has granted a similar motion to CVC in the '115 Interference (see "PTAB Grants CVC Motion for Marraffini Deposition"). "Because Dr. Marraffini's testimony is equally as pertinent to the present interference as it is to the 115 Interference," Toolgen argues, "additional discovery concerning Dr. Marraffini is warranted here, as well." Toolgen asks as part of this motion for "copies of documents from Dr. Marraffini produced in the 115 Interference and to participate in, including by examination or cross-examination, any deposition examination or cross-examination of Dr. Marraffini in the 115 Interference," as well as leave to serve its own subpoenas for documents or further deposition.
Toolgen's Motion No. 8 in the '126 Interference is for judgment under 37 C.F.R. § 41.121(a)(1) that all Broad's patents and applications are unenforceable for inequitable conduct. The basis for this motion asserted by Toolgen is purported irregularities in how certain applications were designated first as having post-AIA and then pre-AIA status, as well as statements that "Zhang's lab had reduced to practice a working CRISPR-Cas9 cleavage system in a eukaryotic cell prior to May 2012," which Toolgen asserts was untrue.
Toolgen's Motion No. 9 in the '126 Interference and Motion No. 6 in the '127 Interference are for a protective order under 37 C.F.R. § 42.54 to allow Toolgen to file its priority statement under seal. The basis for this motion is to protect "sensitive and confidential information" from disclosure to "third-party competitors, such as Sigma-Aldrich." (It should be remembered that CVC asked for a similar protective order in the '115 Interference, which the Board denied; see "Board Denies CVC Motion to Seal Priority Statement".)
Toolgen's Motion No. 10 in the '126 Interference and Motion No. 7 in the '127 Interference is a miscellaneous motion under 37 C.F.R. § 41.104(a) for the Board to order the '126 and '127 Interferences to proceed on the same schedule.
Finally, Toolgen's Motion No. 11 in the '126 Interference and Motion No. 8 in the '127 Interference are each motions under 37 C.F.R. § 41.208(a)(4) for judgment based on priority of invention.
The Board having set February 4th as the date for a teleconference with each set of parties jointly, the Board's Order notifying the parties as to which motions they are authorized to file and which have been deferred or denied is expected within the week. During the call, the parties were able to inform the Board more specifically of the bases for their motions, provide a proffer if the Board needs additional evidence or information, and provide opposing parties the opportunity to give the Board their views. With the Order on which motions are permitted, the Board will also set a briefing schedule. All these events will be the subject of future posts.
* The Interference Rules were revised several years ago and collected with all post-grant proceedings in Chapter 41 of the C.F.R. Nevertheless, the current rules have provisions for such stays which it can be expected the Board will consider when it decides whether to grant leave for Toolgen to file a brief in support of this motion.
** These include PCT/US2013/074611; PCT/US2013/074667; PCT/US2013/074691; PCT/US2013/074736; PCT/US2013/074743; PCT/US2013/074790; PCT/US2013/074800; PCT/US2013/074812; PCT/US2013/074819; and PCT/US2013/074825.
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