Broad Information Substantive Preliminary Movement No. 3 to Designate Claims as not Comparable to Depend in Interference No. 106,133

By Kevin E. Noonan

Broad InstituteOn December third, Junior Occasion the Broad Institute, Harvard College, and MIT (collectively, Broad) filed its Contingent Preliminary Movement No. 3 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Occasion), asking the Patent Trial and Enchantment Board to designate sure claims deemed within the Declaration as akin to the Interference Depend as not having such correspondence, beneath 37 C.F.R. 4 §§ 41.121(a)(1)(i) and 41.207(b)(2).  These claims fall into 5 discrete classes:

Class A:      Staphylococcus aureus Cas9 protein (“SaCas9”);
Class B:      Cas9 chimeric CRISPR enzyme;
Class C:      Cas9 with two or extra nuclear localization indicators (“NLSs”);
Class D:      Cas9 fused to specified protein domains; and
Class E:      Claims which might be generic as to RNA and likewise don’t specify integration of a donor polynucleotide sequence (“Donor Template Integration” claims), i.e., the one claims that ought to stay designated as akin to Depend 1 are these which might be both (i) restricted to single molecule RNA (“sgRNA”), or (ii) require Donor Template Integration and are usually not in any other case individually patentable.

Broad units forth the claims they ask be de-designated for every instance, however maybe extra telling is the recitation of the claims remaining as akin to the Depend ought to the movement be granted:  “claims 4, 11 and 18 of U.S. Patent No. 8,697,359 . . . , declare 5 of U.S. Patent No. 8,771,945 . . . , all claims (1-18, 30) of U.S. Patent No. 8,795,965 . . . , claims 2, 5 and 30 of U.S. Patent No. 8,906,616 . . . , claims 8-9, 14, 16 and 27 of U.S. Patent No. 9,840,713 . . . , and claims 14-16 of Utility No. 14/704,551 . . .” (references to displays and abbreviations omitted).

The transient units forth the related traits of the “McKelvey” Depend comprising a declare from a Broad-involved patent (declare 18, U.S Patent No. 8,697,359) or declare 31 of Sigma-Aldrich’s U.S. Utility No. 15/456,204.  Broad makes as a foundation for its movement the excellence that the Broad portion of the Depend is directed to CRISPR-mediated cleavage in a eukaryotic cell (that “cowl[s] many various innovations which might be individually patentable from Depend 1”) whereas Sigma-Aldrich’s portion of the Depend recites CRISPR-mediated cleavage coupled with integration of a heterologous DNA molecule, termed “Donor Template Integration,” ought to be de-designated as not akin to Depend 1 of the ‘133 Interference (whereas being “generic” for the construction of the RNA CRISPR part, i.e., single- or dual-molecule embodiments).  The distinctions Broad attracts in its argument monitor the classes of claims set forth above, and Broad argues that “[n]one of many claims directed to these enhancements and choices are anticipated by, or apparent in view of Depend 1 if thought of as prior artwork alone or in correct mixture with the prior artwork.”  The transient reminds the Board that in associated Interference No. 106,132, Sigma-Aldrich itself argued that these CRISPR embodiments weren’t apparent in view of what was recognized within the artwork in December, 2012  (seeSigma-Aldrich Information Substantive Preliminary Movement 1 to Change the Depend in Interference No. 106,132“).  Broad additionally argues that “Proposed Depend 2 within the 132 Interference and Depend 1 (in addition to Proposed Depend 3) listed here are materially the identical with respect to the related Cas9 and NLS associated limitations” in help of its Movement.

Attending to the purpose, the transient argues that Broad’s claims “which might be each generic as to RNA and never restricted to Donor Template Integration” ought to be de-designated as not akin to Depend 1 of the ‘133 Interference as declared (along with the classes of claims set forth above).  “The one claims that ought to correspond to Depend 1 are people who both are restricted to make use of of sgRNA (and so correspond to the Broad half of Depend 1) or recite Donor Template Integration (and so correspond to the Sigma half of Depend 1),” Broad argues.  As well as, Broad argues that its generic claims “that don’t restrict the RNA configuration to sgRNA are at the moment designated as akin to Depend 1,” regardless that the Depend is proscribed to single-molecule information RNA (sgRNA) and thus mustn’t correspond to the Depend (whereas conceding that the time period “information RNA” was restricted to sgRNA by the Board in associated Interference No. 106,115).  Broad helps its argument by noting that neither Sigma-Aldrich on this interference or the associated ‘132 Interference, nor ToolGen in associated Interference No. 106,126 restrict the time period “information RNA” to the sgRNA species.  And beneath the “plain that means” rubric of declare building, Broad argues, the time period “information RNA’ shouldn’t be restricted to the sgRNA species.  Thus, in response to Broad, the Board has foundation to de-designate a lot of its claims are usually not akin to the “Broad” portion of McKelvey Depend 1 of this interference.

Furthermore, Broad argues that a lot of its claims are usually not restricted to eukaryotic CRISPR embodiments reciting the limitation for Donor Template Integration as recited within the Sigma-Aldrich portion of the McKelvey Depend on this interference as declared.  Broad argues the patentable distinction between the invention(s) encompassed by this portion of the Depend and Broad’s claims is supported by Sigma-Aldrich’s constant arguments, throughout prosecution of its ‘204 application-in-interference.  Thus, Broad argues such claims don’t correspond to the Depend and the Board ought to accordingly de-designate them from this interference.

The transient then units forth intimately how its claims restricted to every of the classes set forth above are neither anticipated not rendered apparent by the Depend as declared and thus are independently patentable from the subject material outlined by the Depend.  These claims are recognized within the transient as follows:

Class A:      All the Concerned claims of U.S. Patent No. 8,865,406, U.S. Patent No. 8,895,308 and Utility No. 15/330,876, as a result of these claims are restricted to utilizing Staphylococcus aureus Cas9 protein (“SaCas9”) and, on the related occasions (2012) “there have been greater than 600 bacterial Cas9 orthologs that had been recognized” however no suggestion of utilizing SaCas9 in eukaryotic CRISPR embodiments; furthermore, SaCas9 and SpCas9 (from Streptococcus pyogenes) shared solely 17% amino acid sequence id.  Relating to the obviousness query Broad additionally asserts a number of of the target indicia of non-obviousness, together with sudden outcomes and business success.

Class B:      All the concerned claims of Broad’s U.S. Patent No. 8,889,418 (“418 patent”) reciting Cas9 chimeric CRISPR enzymes, as a result of these claims are usually not anticipated by the Depend nor would these claims be apparent, a place Broad asserts Sigma-Aldrich itself superior throughout prosecution of its ‘204 software in interference and within the associated ‘132 Interference (supported by knowledgeable testimony).

Class C:      All the claims of U.S. Patent No. 8,871,445, U.S. Patent No. 8,932,814, declare 7 of U.S. Patent No. 8,993,233, claims Sep 11 of U.S. Patent Utility No. 14/704,551, and declare 34 of U.S. Patent Utility No. 15/330,876, which recite Cas9 with two or extra nuclear localization indicators (“NLSs”).  Broad argues that the Broad portion of the Depend is proscribed to Cas9 species bearing a single NLS (and therefore doesn’t anticipate) and concerning obviousness that “a POSA would have understood that including amino acids to a protein akin to Cas9 may alter its folding affecting its construction and performance in ways in which weren’t predictable.”  This place, Broad argues, is one Sigma-Aldrich additionally took throughout ex parte prosecution of the ‘204 application-in-interference and within the associated ‘132 Interference.  Lastly, Broad argues sudden leads to the disclosure set forth in U.S. Utility No. 61/736,527, filed December 12, 2012.

Class D:      All the claims (1-43) of Broad’s U.S. Patent No. 8,993,233, all claims (1-28) of U.S. Patent No. 8,999,641, claims 18, 19, 25, 29-30, and 36 of U.S. Patent No. 9,840,713, and declare 21 of U.S. Patent Utility No. 15/330,876, having claims reciting Cas9 fused to specified protein domains.  Broad argues that the Depend recites no such limitation and thus doesn’t anticipate and, as for obviousness, “there isn’t a instructing or suggestion in Depend 1 or the prior artwork directing a POSA to switch the naturally occurring Cas9 protein sequences as set forth in these claims” and the sudden outcomes set forth within the specs of those Broad patents and functions helps a conclusion of non-obviousness.  Additionally, Broad right here as elsewhere notes that Sigma-Aldrich has taken a like place the associated ‘132 Interference (albeit directed to NLS-modified Cas9 species).

Class E:      Claims Broad argues don’t correspond to the Depend as declared on this class “fall into one among three teams:”

1) “claims that don’t require an RNA part in any respect”;

2) “claims which might be generic as to the RNA part and don’t use the time period ‘information RNA'”; and

3) “claims that use the time period ‘information RNA’ however are nonetheless generic as to the RNA part beneath the correct building of ‘information RNA.'”

These claims embrace claims 15, 17-26, and 28-41 of U.S. Patent No. 9,840,713; claims 1-24 of U.S. Patent No. 8,889,418; declare 13 of U.S. Patent No. 8,871,445; claims 1, 2, 5, and 30 of U.S. Patent No. 8,906,616; claims 1, 8, 9, and 14 of U.S. Patent No. 9,840,713; claims 1, 4, 8, 11, 15, and 18 of U.S. Patent No. 8,697,359; claims 1 and 5 of U.S. Patent No. 8,771,945; claims 1, 6, 10, 25, 29, and 30 of U.S. Patent No. 8,895,308.

Broad argues that these claims inter alia recite the RNA part of the CRISPR-Cas9 advanced as generic with regard to single- and dual-molecule embodiments.  Thus these claims don’t correspond to the Broad portion of the Depend (though they’re inside its scope to the extent that they learn on sgRNA CRISPR embodiments).  Broad addresses the truth that the Board disagreed with this argument in denying its Preliminary Movement No. 3 within the ‘115 Interference (seePTAB Decides Events’ Motions in CRISPR Interference“) however asserts that “proof supplied herewith reveals that the BRI of “information RNA” in Broad’s claims will not be so restricted” (though it’s unclear how the proof set forth herein is considerably totally different).  Nonetheless Broad argues that the plain that means beneath the “broadest cheap interpretation” (BRI) normal helps its arguments, citing Bamberger v. Cheruvu, 55 U.S.P.Q.2nd 1523, at *2 (B.P.A.I. 1998), and that their interpretation is additional supported by how the time period “information RNA” was used within the artwork in 2012, within the Sigma-Aldrich application-in-interference right here, and by ToolGen within the associated ‘126 Interference.  Broad additionally argues the intrinsic proof, particularly the disclosures within the specs of its patents and applications-in-interference present a sample of revealing (and claiming) generically adopted by narrowing disclosures and claims to specific RNA species.  Broad invokes the doctrine of declare differentiation on this regard, and recites what it characterizes as “the hierarchy of declare building as counseling in opposition to decoding claims “in a approach that renders them void, meaningless, or superfluous,” citing Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1288 n.10 (Fed. Cir. 2017), and reciting particular cases as U.S. Patent Nos. 8,895,308 and eight,909,616.  To the extent generic “information RNA” is disclosed, Broad additional argues that decoding these claims to fall throughout the scope of a Depend directed to sgRNA embodiments would exclude these (most well-liked) embodiments from the claims, which is “hardly ever if ever appropriate,” citing Ex Parte Andrew Graham, Ando Feyh, & Bernhard Gehl, Enchantment No. 2017-009616, 2018 WL 4356999, at *3 (P.T.A.B. Aug. 23, 2018), and MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1333 (Fed. Cir. 2007).  Lastly, Broad recites extrinsic proof in help of its arguments, together with Jinek 2012 (A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 337: 816-821), Sigma-Aldrich’s disclosure, the disclosure in ToolGen’s application-in-interference at concern within the ‘126 Interference.

With regard to the Sigma-Aldrich portion of the McKelvey declare Depend, the Board’s failure to de-designate these claims would “work an unfairness to Broad and unfairly reward Sigma for limiting its claims in prosecution” as a result of Sigma itself had represented to the USPTO, in each ex parte examination and within the associated ‘132 Interference that such claims have been patentably distinct from claims falling throughout the scope of the Broad portion of the Depend (i.e., directed to “cleavage-only” elements of CRISPR practiced in Broad’s claims).

Lastly, Broad recites arguments raised in different interferences concerning its “greatest proofs” associated to dual-molecule RNA embodiments of CRISPR and to the Board’s choice (affirmed by the Federal Circuit) in Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F. 3d 1264, 1268 (Fed. Cir. 2003), directing that the one-way take a look at for figuring out interference-in-fact can be “over-inclusive” as a result of a “‘genus [that] was invented earlier than’ a species is ‘individually patentable from, the species’ for the needs of figuring out an interference-in-fact.”

The transient is supplemented with Appendices together with, inter alia, a Abstract Chart of Grounds and Claims (Appendix C) and a Declare Differentiation Chart (Appendix D).

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