It is well to recall that the battle over inventorship and thus ownership of CRISPR technology is not limited to the parties in the various interferences surrounding the Doudna and Zhang patents and applications (see "CRISPR Battle Joined Again" and "The CRISPR Chronicles: Enter Toolgen"), as well as remembering that the technology continues to be developed and those developments are or will also be subject to patent protection. Another party already identified in the space is The Rockefeller University, and on Thursday its scientists prevailed in an interference proceeding before the Patent Trial and Appeal Board captioned SNIPR Technologies Ltd. v. The Rockefeller University (naming Luciano Marraffini as one of this party's inventors).
In the Declaration of Interference No. 106,123, SNIPR was designated as the Junior Party and all claims of all five of its patents were involved (10,463,049; 10,506,812; 10,524,477; 10,561,148; and 10,582,712). Senior Party The Rockefeller University had all claims of its pending U.S. Application No. 15/159,929 designated as corresponding to the Count. The PTAB recited the Count in this interference in the alternative, as either Claim 1 of Patent No. 10,582,712 or Claim 24 of the 15/159,929 application:
SNIPR '712 patent, claim 1:
1. A method of modifying a mixed population of bacteria, wherein the mixed population comprises a first bacterial subpopulation and a second bacterial sub-population,
wherein the first bacterial sub-population comprises a first bacterial species and the second bacterial sub-population comprises host cells of a second bacterial species,
wherein the second bacterial species is a different species than the first bacterial species, the method comprising
a. contacting the mixed population of an engineered nucleic acid sequence for producing a host modifying crRNA (HM-crRNA), and
b. producing the HM-crRNA in the host cells,
wherein the HM-crRNA is operable with a Cas nuclease in the host cells,
wherein the engineered nucleic acid sequence and the Cas nuclease are comprised by an HM-CRISPR/Cas system, and
wherein the HM-crRNA comprises a nucleic acid sequence that is capable of hybridizing to a target sequence in the host cells to guide the Cas nuclease to modify the target sequence in the host cells;
whereby the host cells are killed or growth of the host cells is reduced, thereby reducing the proportion of the host cells and altering the relative ratio of the first and second bacterial sub-populations in the mixed population of bacteria; and
wherein the mixed population of bacteria comprises E. coli.
Rockefeller '929 application, claim 24:
24. A method for killing targeted bacteria in a mixed bacterial population comprising:
providing a pharmaceutical composition comprising a pharmaceutically acceptable carrier and packaged, recombinant phagemids that are packaged in phage capsids,
wherein the packaged phagemids comprise a clustered regularly interspaced short palindromic repeats (CRISPR) system,
wherein the CRISPR system comprises DNA encoding: i) a type II CRISPR-associated enzyme; and ii) a targeting RNA that targets at least one bacterial chromosome at a target site; and
contacting the bacterial population with the pharmaceutical composition,
wherein the contacting with the pharmaceutical composition introduces at least some of the phagemids into at least some of the bacteria in the bacterial population,
wherein subsequent to the introduction of the phagemids, the bacteria into which the phagemid is introduced expresses the targeting RNA and the type II CRISPR-associated enzyme,
wherein the expressed type II CRISPR-associated enzyme cleaves the bacterial chromosome at the target site of the targeting RNA, and
wherein the cleavage of the bacterial chromosome at the target site kills the bacteria and
wherein the mixed bacterial population comprises one or a combination of bacterial species selected from the group consisting of Staphylococcus, Clostridium, Bacillus, Salmonella, Helicobacter pylori, Neisseria gonorrhoeae (wherein the italicized portions of the claim are recited in independent claim 20 from which claim 24 depends).
The interference was declared on June 11, 2020 (about eight months before the Board declared Interference Nos. 106,126 and 106,127), but the Board reached a Final Judgment in this interference on Friday, while the '126 and '127 Interferences have not reached the end of the Preliminary Motions phase. This in large part is due to SNIPR's decision not to file priority statement (presumably because as Junior Party they were obliged to do so to avoid judgment, 37 C.F.R. § 41.204(a)(3), and could not bear the burden of this standard).
Each Party asked for and the Board granted leave to file certain Preliminary Motions:
For Senior party Rockefeller: 3 motions, where:
Motion No. 1 is a Motion of unpatentability under Section 112(a)
Motion No. 2 is a Motion of unpatentability under Section 112(b)
Motion No. 3 is a Motion contingent on the Board granting SNIPR Motion No. 2
For Junior party SNIPR: 6 motions, where:
Motion No. 1 is a Motion to Terminate because its effective filing dates were after AIA
Motion No. 4 is a Motion to Deny Rockefeller priority benefit to 61/761,971
Motion No. 6 is a Motion to designate claims as not corresponding to count
Motion No. 2 is a Motion of unpatentability under Section 112
Motion No. 5 is a Motion to Substitute the Count.
The Board substantively decided only two motions, both from SNIPR. The most significant is Motion No. 1 (which the Board denied), where SNIPR argued that the Director through the Board had exceeded his authority by declaring the interference, because none of its involved patents had a priority date earlier than the effective date of the Leahy-Smith America Invents Act (AIA) (the earliest effective filing date accorded SNIPR was an International Filing Date of May 6, 2016). Rockefeller's involved application was entitled to the prior "first to invent" provisions of the 1952 Patent Act because the Board had accorded this application the benefit of U.S. Provisional Application No. 61/761,971, filed February 7, 2013 (i.e., prior to the March 16, 2013 effective date of the AIA). As set forth in the Decision on Motions, SNIPR bore the burden of establishing this interpretation of the statute under 37 C.F.R. § 41.208(b) and § 41.121(b).
SNIPR's argument was simple: because none of their patents had earliest filing dates before March 16, 2013, Congress had abolished interferences as a method of determining priority for these patents and thus the Declaration was contrary to the statute. Concomitant with this argument was the dispositive one that accordingly, the prior "first to invent" standard under 35 U.S.C. § 102(g) did not apply. If there were to be a Patent Office determination of priority, SNIPR argued it was cabined to the derivation statute newly enacted with the AIA (and under the particular factual circumstances in this case undoubtedly Rockefeller could not prevail should the Board grant this motion).
The Board rejected SNIPR's argument on several grounds. First, the Board took recourse in the provisions of the AIA that explained the effective date for each of the various changes that accompanied the transition to a "first inventor to file" regime. Specifically, the Board cited Section 3(n)(2) of the AIA that specified that for interfering patents, "[t]he provisions of sections 102(g), 135, and 291 of title 35, United States Code" would continue to apply to any patent that "contains or contained at any time" a claim having an effective filing date prior to [18 months from the AIA's enactment, i.e., March 16, 2013] or contained a "specific reference" to any patent or application having such a claim. The Board interpreted this provision to contradict (and provide basis for them to reject) SNIPR's argument that interferences were abolished after March 16, 2013.
Second, the Board did not interpret Section 3(j) of the AIA (as SNIPR does) to have abolished interferences between patents or applications that satisfy Section 3(n)(2) and those that do not (as the SNIPR patents do not).
Third, the Board posed the rhetorical question of what is the remedy for patent applicants like Rockefeller here if it were to adopt (or Congress intended, which the Board's opinion suggests they do not think it does) SNIPR's position that interferences were precluded to involve patents such as theirs against applications like Rockefeller's that do satisfy Section 3(n)(2)? This question is posed in the context of the plain language of the statute maintaining interferences for patents such as Rockefeller's that satisfy Section 3(n)(2) AIA. In other words, would Congress have enacted a nullity for such patents or applications under circumstances as here where the interfering subject matter is disclosed and claimed in a patent or application that does not satisfy Section 3(n)(2)? "Congress could have ended all interferences at the implementation of the AIA," according to the Board, and under those circumstances "different parties may both be issued claims for the same patentable invention even when one party has an effective filing date before 16 March 2013" (an unlikely scenario in view of the consistent interpretation of the statute that the phrase "a patent" in the statute indicates a single inventive entity), but that is not the law Congress enacted in the Board's view. The point as the Board interpreted Congressional intent was that "Congress did not expressly qualify its choice to continue interferences as being only when both parties' claims have an effective filing date before 16 March 2013." And the Board further did not give credit to SNIPR's suggestion that priority to Rockefeller's claims could be established in "a different proceeding," any detailed of which SNIPR left unspecified in its brief.
The issue beomes a choice, according to the Board, of whether SNIPR is correct that "Congress's express choice to subject a subset of applications and patents to the previous interference provisions reinforces Congress's intent to exclude applications and patents outside that subset, like SNIPR's, from interference proceedings" or whether the Board's view that "the decision to continue interferences, in section 3(n)(2), indicates that Congress contemplated interferences between pre-AIA and post-AIA applications and patents," it being self-evident which view the Board would consider most consistent with Congressional intent.
Finally, the Board rebutted SNIPR's contention that the Director has the discretion to terminate the interference sua sponte, citing the statutory mandate under pre-AIA 35 U.S.C. § 135(a) that "[t]he Board of Patent Appeals and Interferences shall determine questions of priority of the inventions and may determine questions of patentability" (emphasis added), as well as Junior Party's contention that the "Board should clarify that any priority of invention showing by Rockefeller cannot invalidate SNIPR's claims." Under pre-AIA 35 U.S.C. § 135(a), the Board believes it is bound to render a judgment against SNIPR if it cannot establish priority over Rockefeller (which it cannot do because it failed to file any priority statement). Accordingly, the Board denied SNIPR Motion No. 1.
The Board also denied SNIPR's Motion No. 6 to designate certain claims as not corresponding to the Count. This motion was based on these claims all reciting the limitation that the claimed method "reduces the growth of the host cells by at least 5-fold." In order to prevail, the Board noted, SNIPR's burden was to show that these claims would not have been obvious over disclosure of methods "whereby the host cells are killed or growth of the host cells is reduced" or whereby targeted bacteria are killed, as recited in the language of the Count. SNIPR's assertions in support of its motion included expert testimony and interpretations of what was known in the prior art. These were unavailing because the Board determined that the Count itself rendered the claims obvious. While issues of what was known in the art can be relevant, the Board stated properly that "the main issue is whether the subject matter of the count renders obvious the subject matter claimed, not whether the prior art does." In reciting and reviewing SNIPR's arguments, the Board concluded that "SNIPR fails to meet its burden in seeking the requested relief" under 37 C.F.R. §§ 41.208(b) and 41.121(b) and hence denied the motion.
The Board dismissed as moot SNIPR Motion No 4, to deny Rockefeller priority benefit (which would make both parties' patents have a priority date after March 16, 2013 and hence be governed by the AIA without the prior law's interference provisions; indeed, SNIPR expressly asked the Board to terminate the interference on those grounds as part of its relief requested in the motion is granted. The Board noted that SNIPR failed to provide sufficient basis in its motion to support its assertions that Rockefeller's provisional application did not provide a constructive reduction to practice of Count 1 of this interference, and even without its priority claim Rockefeller has a first filing date that antedated SNIPR's earliest priority date.
The Board made its priority determination in Rockefeller's favor and dismissed (as moot or otherwise) all remaining motions and entered judgment for Rockefeller.
While too early to know whether SNIPR will file an appeal of this decision, the question of whether the AIA precludes the Director from declaring an interference between an application entitled to the Section 3(n) provisions of the AIA and an application or patent clearly outside the scope of prior law by virtue of an earliest priority date later than March 16, 2013 is unsettled (except for this decision) and is likely to arise in any such appeal in view of the position taken by SNIPR in the interference. While the Board's reasoning appears sound, certainty (to the extent it can be attained) can only be reached by Federal Circuit or, if the question intrigues the Justices, Supreme Court review (the unlikeliness of which is tempered by the Court's tendency to grant certiorari on many statutory interpretation questions regarding the AIA; see "Thryv, Inc. v. Click-to-Call Technologies, LP (2020)"; "Return Mail, Inc. v. United States Postal Service (2019)"; "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc. (2019)"; "Oil States Energy Services, LLC. v. Greene's Energy Group, LLC (2018)"; "SAS Institute Inc. v. Iancu (2018)"; Cuozzo Speed Technologies LLC v. Lee (2016)).