By Kevin E. Noonan —

Last month, Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") filed its reply to an opposition to Broad's motion to correct inventorship filed by Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC"), which was filed as a contingent motion in response to CVC's Substantive Motion No. 3 under 37 C.F.R. § 41.121(a)(1) asking for judgment of unpatentability for all claims in interference under 35 U.S.C. § 102(f) or (if post-AIA) 35 U.S.C. § 115(a) for "failure to name all inventors of the alleged invention" in Interference No. 106,115.

CVC's opposition asserted that Broad has not established that it is entitled to this relief, as required under 37 C.F.R. § 41.121(b).  CVC also argued that Broad did not provide consent for one of the individuals — Shauiliang Lin — to be added as an inventor.  CVC further alleged that the motion is barred by laches and submitted in bad faith.  And finally, CVC asserted that as a matter of jurisdiction the Director — not the Board — has sole authority to change inventorship and that there is no evidence that the Director has delegated this authority to the Board.

The Broad asserts that CVC's motion was a "classic straw man," in part because its motion was a contingent motion and thus would only be considered by the Board if CVC's Substantive Motion No. 3 was granted (and then and only then will Broad and CVC understand which inventors had not been properly named).  This procedural consideration, in Broad's view, makes "quick work" of CVC's argument that Broad had failed to identify the unnamed inventors and that its motion was untimely.  Broad also argues that CVC's other allegations (of bad faith and breach of the duty of candor) are not supported by any evidence and hence "should not detain the PTAB for long"; indeed, Broad characterizes these arguments as a "witch hunt [and] nothing more."

As required by PTAB rules in an interference, Broad's reply methodically goes through CVC's opposition point by point in providing a rebuttal of the allegations therein.  Thus, Broad's argument explicates in detail the procedural deficiencies in castigating Broad for not identifying the unnamed inventors prior to the Board granting CVC's Substantive Motion No. 3 that there are any unnamed inventors to name.  Broad's position is that there are no such inventors.  Referencing the arguments Broad made in its Opposition to CVC's Substantive Motion No. 3 (see "Broad Files Motion Opposing CVC Motion for Misjoinder of Inventorship under 35 U.S.C. § 102(f)"), Broad states that if, despite its arguments therein, the Board grants the motion, then and only then will there be any unnamed inventors to name with regard to its contingent motion to amend inventorship.  And then and only then should the Board grant their motion, citing Egenera, Inc. v. Cisco Sys., Inc., 972 F.3d 1367, 1376 (Fed. Cir. 2020).  This is because in order for the Board to grant CVC's motion the Board would have to have concluded that there were unnamed inventors, for which Broad would be entitled to file its change of inventorship.  (The Catch-22 nature of this argument harkens to a similar quality in some of CVC's arguments regarding inventorship; see "CVC Files Reply to Broad's Opposition to CVC Motion for Misjoinder of Inventorship under 35 U.S.C. § 102(f)".)

With regard to these arguments, Broad asserts that "CVC filed a half-baked motion to try to invalidate Broad's claims based on its allegation of missing inventors without providing any inventorship analysis or appropriate evidence" and "[i]f, despite those failings, the PTAB still finds there are missing inventors, then the relief requested in this contingent motion would be warranted based on the PTAB's finding an  identification of the individuals it deems should have been named as inventors."

Broad uses similar arguments with regard to CVC's laches arguments, to the extent that it would only be after the Board granted CVC's Substantive Motion No. 3 that Broad was under an obligation to correct inventorship.  (While compelling as far as it goes, CVC's argument was rather different:  to the extent that Broad filed the PCT and EP applications that were the subject of a declaration on inventorship by their lawyer Thomas Kowalski, and that this inventorship differed from the inventors named in corresponding U.S. applications and patents claiming the same or substantially the same subject matter, the obligation to square these varying inventorship claims arose then, not only after the Board make its determination in this interference.)  More pertinent to Broad's argument is the focus of the unnamed inventor argument on a particular individual, Dr. Lin. Broad asserts precedent to the effect that laches does not arise when a putatively unnamed inventor moves to be added to an application or patent, including Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 988 F.2d 1157 (Fed. Cir. 1993); Serdarevic v. Advanced Med. Optics, Inc., 532 F.3d 1352 (Fed. Cir. 2008); and Lismont v. Alexander Binzel Corp., 813 F.3d 998 (Fed. Cir. 2016).  Broad asserts no prior belief that there were any unnamed inventors in the patents-in-interference and thus no occasion for laches to arise with regard to inventorship questions.

Broad characterizes CVC's allegations of bad faith as "irresponsible" and "reckless" (as opposed to the laches argument, which is "merely wrong").  Alluding to the BPAI's decision in Nevel v. Hoeller, Patent Int. No. 104,025, Paper No. 65 (B.P.A.I. May 10, 2000), where the Board chastised a party making similar accusations based on inventorship as "fishing expeditions" and "witch hunts" and stated that they would be "aggressively quelched," Broad focuses its argument on the seriousness of CVC's allegations and the deficiencies (in Broad's view) of CVC's evidence.  Its rhetoric rising to meet the seriousness of CVC's allegations, Broad argues:

[CVC] has, at best, advanced a frivolous argument resulting in unnecessary briefing and increased costs for all.  Such behavior should not be condoned nor should it be overlooked.  Here the sword of equity should fall the other way.  See 37 C.F.R. § 42.12; see also Paper No. 2, Standing Order § 208.7 ("An allegation of inequitable conduct or fraud that fails to make out a facially sufficient case may result in sanctions or a referral to the Office of Enrollment and Discipline.").  It is past time for CVC's irresponsible allegations to stop.

Broad's Reply then turns to CVC's procedural argument, that the Director and not the Board is empowered to correct inventorship.  Authority Broad cites in this regard include 37 C.F.R. § 1.48(i) and § 1.324(d), as well as other interference decisions such as Flamm v. Vinogradov, Patent Int. No. 104,807, Paper No. 20 (B.P.A.I. Dec. 11, 2002); Chai v. Frame, 10 U.S.P.Q.2d 1460, Patent Int. No. 101,432 (B.P.A.I. 1988); and Thomas v. Eicken, 219 U.S.P.Q. 900 (B.P.A.I 1983).  The brief distinguishes the authority cited by CVC in its opposition, Honeywell Int'l Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019), and resorts to both the C.F.R. and the M.P.E.P. for instances and circumstances where the Director can delegate her authority, including on an ad hoc basis.

Finally, Broad asserts that lack of consent by Dr. Lin should not be a basis for the PTAB to deny Broad's contingent motion to correct inventorship.  According to Broad, Dr. Lin's consent is not "strictly necessary" (not citing any authority for this point itself, Broad relies on a purported failure by CVC to cite authority to the contrary).  The Broad shores up this lack of authority by relying on MPEP § 1481.02(I) that suggests than faced with refusal by an unnamed inventor to assent to being named a patent holder "may wish" to file a non-broadening reissue application, because the unnamed inventor's assent is not required in that situation.  The relatively thin reed of the "may wish" locution "indicates discretion when an inventor does not consent—not an absolute bar to correction" according to the Broad.  Broad's arguments on this issue in the brief conclude with a citation of CVC's authority, Honeywell Int'l Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019), for its holding that "it was an abuse of discretion for the PTAB to require Honeywell to show that the requirements to correct the priority chain of a patent had been met before authorizing Honeywell to file a motion for leave to petition the Director for a Certificate of Correction."

By Kevin E. Noonan —

Last December, Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") filed its Substantive Motion No. 3 under 37 C.F.R. § 41.121(a)(1) asking for judgment of unpatentability for all claims in interference under 35 U.S.C. § 102(f) or (if post-AIA) 35 U.S.C. § 115(a) for "failure to name all inventors of the alleged invention" against Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") in Interference No. 106,115.  In support of its motion, CVC argued that Broad deliberately misidentified the inventors on its involved patents and applications in the interference.  These allegations were based on differences between the named inventors in the patents- and applications-in-interference and the inventors named in a declaration by the Broad's patent attorney during a European opposition (EP 277146); it may be recalled that such irregularities involving a Rockefeller University inventor (Dr. Luciano Marraffini) not named in the EP application were the basis for that patent to be invalidated (see "The CRISPR Chronicles — Broad Institute Wins One and Loses One").  More recently, Broad filed is motion opposing CVC's allegations of misjoined inventorship (see "Broad Files Motion Opposing CVC Motion for Misjoinder of Inventorship under 35 U.S.C. § 102(f)").  Last week CVC filed its Reply.

Reply briefs in motions before the PTAB are constrained by page length and a format wherein the movant must address all grounds of opposition raised against the motion, and CVC's Reply conforms to both constraints.  The brief sets forth, step by step, each allegation and ground of opposition raised by Broad in its opposition brief.

Thus, CVC begins it responsive argument with Broad's attorney's (Thomas Kowalski) argument.  The brief notes that the evidence it has relied upon for misjoinder of invention is based on a declaration Mr. Kowalski submitted to the European Patent Office in an application related to patents-in-interference (specifically, those related to the EP equivalents of PCT/US2013/074611, PCT/US2013/074790, and PCT/US2013/074667).  CVC's motion relied upon an analysis of the claimed subject matter disclosed and claimed in certain of these EP applications, the corresponding patents-in-interference, and differences in inventorship between applications claiming the same or sufficiently closely related subject matter.  CVC broadly argues that Dr. Baily's analysis and conclusions were not challenged nor factually rebutted by any evidence presented in support of Broad's opposition.

Broad's first challenge to CVC's arguments was brought against their expert witness Dr. Bailey for lack of proper credentials (he is not a lawyer) and for not making the comparison using, inter alia, claim charts.  CVC argues that their witness's credentials were not relevant because the analysis was of differences in the face of representations under oath by Mr. Kowalski who certainly had the proper credentials ("if [Mr.] Kowalski's analysis is correct, then those individuals who made the inventive contributions should have been (but were not) named as inventors of the involved patents and application").  Expert witness Bailey's testimony was based on an understanding of a person of ordinary skill in the art comparing the claims and disclosure of the EP applications that were the subject of Mr. Kowalski's declaration and certain patents-in-interference here, which to the extent the claimed subject matter was sufficiently the same yet inventorship differed supported CVC's misjoinder motion (the basis of this analysis was exemplified with regard to Cas9 "ortholog designs" in these applications and patents).  As stated by CVC in its brief, "Bailey considered, from the perspective of a person having ordinary skill, the relevant specification and claim language, before concluding that certain claims of Broad's PCT applications and its involved patents and application cover the same invention (italics in brief).  This is shown, for example, by comparison between "relevant claim limitations [in] the '691 PCT application and the '233 patent."

While acknowledging that Dr. Bailey had not performed a conventional claim comparison (appropriately so, he not being a patent attorney), CVC argued that "CVC's motion identifies relevant terms (pertinent to Kowalski's assessments and recited in Broad's involved claims) and offers comparisons sufficient to support the requested relief, all supported by Bailey's declaration (italics in brief).  In a related criticism, CVC argued that Broad's insistence that Dr. Bailey's analysis was deficient (inter alia, for not performing a "claim-by-claim analysis") "ignores [the Broad's] own attorney's inventorship analysis" and that "[n]othing more is required to establish that Broad failed to name the correct inventors than its attorney's sworn testimony that these individuals made inventive contributions."  Similarly, CVC argued that criticism that its analysis had not considered the consistencies in the inventorship analyses between the EP applications and the patents-in-interference was inapposite because it was only the inconsistencies that are relevant to their misjoinder motion.  Nor, according to CVC, were the various priority relationships between these applications or patents relevant; what was relevant were the differences in inventorship in applications and patents having the same claimed subject matter.

Finally on substantive issues, CVC countered Broad's argument that statements by its attorney cannot be used as admissions in this interference.  According to CVC, this is contrary to Fed. R. Evid. 801(d)(2), which apply in interferences under 37 C.F.R. § 42.62, as admissible admissions against interest.  CVC's brief cites a variety of legal precedent contrary to Broad's argument, including Williams v. Union Carbide Corp., 790 F.2d 552, 555-556 (6th Cir. 1986), and U.S. v. McKeon, 738 F.2d 26, 30 (2d Cir. 1984) (citing Oscanyan v. Arms Co., 103 U.S. 261, 263 (1880) (none of which apparently in either the patent context or involving proceedings before the U.S. PTO or PTAB).  More relevant are CVC's arguments that Broad relied upon Mr. Kowalski's declaration and should not now be allowed to disclaim it ("Broad cannot use the Kowalski Declaration to support its European opposition proceeding and in a later proceeding, like this interference, discount and abandon the same sworn testimony"), citing Pfizer Inc. v. Teva Pharm. USA, Inc., 2006 WL 3041102 at *4-5 (D.N.J. 2006) and perhaps most tellingly, Therasense, Inc. v. Becton Dicksinson & Co., 864 F.Supp.2d 856 (N.D. Cal. 2012).  CVC also supports its argument that Mr. Kowalski's declaration is admissible in this interference in support of CVC's motion for invalidity due to misjoinder because it is an admission against interest, citing Garrido v. Holt, 547 Fed. Appx. 974, n.3 (Fed. Cir. 2013), and Fed R Evid. 804(b)(3) and distinguishing precedent cited by Broad in its opposition.

Procedurally, CVC argued that Broad's motion to change inventorship as a remedy to any infirmities in inventorship is not appropriate for the reasons set forth in its opposition to Broad's motion for this remedy (see "CVC Files Substantive Motion No. 3 (for Improper Inventorship) and Broad Opposes"), as well as being barred by laches and purported bad faith.  Finally, CVC reiterates in brief its argument that only the Director is empowered under the statute to file a Certificate of Correction in an inventorship dispute and there is no evidence that the Director has delegated this authority to the Board.

By Kevin E. Noonan —

Last week, Junior Party The University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") filed its reply to Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") motion in opposition (see "Broad Files Motion in Opposition to CVC Priority Motion") to CVC's motion for priority in Interference No. 106,115.

The Reply is (relatively) direct and to the point (motivated no doubt as much by the page limit in Reply briefs as to the rhetorical force of a short, pithy, to-the-point argument).  (Although to be fair the brief begins with a reminder that the CVC inventors "revolutionized the field of genome editing, giving the world a new system capable of cleaving and editing genes in eukaryotic cells," mixing the irrebuttable with the precise question the Board is asked with answering.)  The critical component of this achievement (no matter who did it) is the development of the combination of the tracr RNA and crRNA into a single guide RNA (sgRNA).  Asserting their multiple instances of earlier conception, CVC contends that these conceptions predated any conception by the Broad's inventors, accompanied by CVC's diligence in achieving reduction to practice.

The brief also counters Broad's long-running narrative, extending from the earlier interference between these parties (No. 106,048), that those skilled in the art would not have thought performing CRISPR in eukaryotic cells would be a routine extension of CVC's undoubted successes in performing prokaryotic CRISPR.  The brief asserts "new" testimony from its own witnesses (Barrangou and Sontheimer) as well as testimony adduced from Broad's collaborator Dr. Marraffini to the contrary.  The brief attempts to turn the Broad's inventors' achievements against Broad, as being actual corroboration of their assertions, by referencing Dr. Marraffini's testimony suggesting derivation of the sgRNA concept from a scientific talk by one of the CVC inventors, and then contending that the straightforward reduction to practice of this concept by Broad's inventors is actually evidence that doing so was straightforward and routine.

The brief sets out three reasons why CVC should prevail on the priority question:

• First, CVC argues earlier conception, coupled with "reasonable diligence" in actual reduction to practice.  And this "definite and permanent idea never changed," according to CVC, evidenced by its use in all later actual reduction-to-practice events.

• Second, CVC had conceived of a "preformed" CRISPR-Cas9 complex that they showed (on August 9, 2012) could achieve CRISPR-mediated genetic changes in eukaryotic cells by microinjection.  This method for achieving CRISPR in eukaryotic cells occasions none of the technical impediments Broad has asserted against eukaryotic CRISPR, and neither the Count nor the claims-in-interference are limited to specific methods of introducing CRISPR-Cas9 into eukaryotic cells.  In addition, CVC argues with regard to this reason that Broad has not provided any evidence that CVC's diligence was deficient (other than attacking the completeness of CVC's conception based on purported failure of actual reduction to practice attempts).

• Third, CVC finally gives full-throated voice to their allegation that the Broad inventors derived eukaryotic CRISPR from CVC's scientists.  The allegation is based on the testimony CVC adduced from Dr. Marraffini in his deposition, to the effect that Dr. Marraffini disclosed to the Broad inventors CVC's sgRNA embodiment after learning of it from review of a confidential manuscript and attending a scientific presentation.  This evidence is supported, according to CVC, by evidence from a graduate student working under Dr. Zhang that Broad's experiments relating to eukaryotic CRISPR had "all failed" prior to Dr. Marraffini's disclosure.

With regard to the first of these reasons, CVC reiterates the evidence it has proffered for conception as early as March 1, 2012.  (While a necessary part of their argument, the facts of CVC's conception(s) are not in dispute; rather, Broad has argued that the history of CVC's attempts to reduce the invention to practice, which is their view was protracted due to the non-routine nature of these experiments, should be held to mean that CVC's conception was not complete until actual reduction to practice, which occurred after Broad's June 26, 2012 conception date.)  CVC's brief in this regard focuses on elements of its conception with respect to various features of the CRISPR-Cas9 system (the presence of a nuclear localization sequence, NLS, for example), as well as the formation of a CRISPR-Cas9 RNP in vitro capable of being introduced into eukaryotic cells by microinjection.  Moreover, CVC argues that the embodiment it relies upon for priority is the same embodiment disclosed in Example 2 of its P3 application (USSN 61/757,640, filed January 28, 2013; see "PTAB Decides Parties' Motions in CRISPR Interference"), for which the Board had recognized its sufficiency as for at least constructive reduction to practice of eukaryotic CRISPR:

And regarding Broad's assertions that their inventors had "adapted" CRISPR for eukaryotic applications, CVC argues this embodiment had overcome any such impediments:

Because the Board rendered this decision with regard to their motion for priority benefit, CVC argues, constructive reduction to practice of this embodiment prior to Broad's earliest asserted conception date mandates the Board to grant its motion of priority of claims corresponding to the Count.

CVC also addressed Broad's various arguments regarding purported deficiencies in its conception, again with reference to this specific embodiment of eukaryotic CRISPR (and characterizing Broad's argument as "fabricat[ing] an illusion of doubt in the inventors' minds by cataloging snippets from 12 various CVC documents").  According to CVC, all Broad's "evidence" of CVC's deficiencies "simply reflect that the inventors understood and considered these routine implementation issues during the process and, at all stages, had a plan to address them," supported by inventor testimony.

With regard to CVC's second reason it is entitled to priority judgment, the brief argues complete conception consistent with the elements of Count 1:

This evidence establishes that CVC's conception was "definite and permanent" according to the brief, again relying on assertions by the Board regarding Example 2 of CVC's P3 priority application.  The brief asserts for the significance of this embodiment as actual reduction to practice regarding Broad's arguments that CVC's conception was deficient:

There is no need for codon optimization, RNA or protein expression, concomitant folding, and co-localization of RNA and protein, because the complex is already formed before injection.  The use of pre-formed complexes also minimizes RNA and protein degradation, because the complex is protected from cellular factors, as it is in bacterial host cells [Testimony of Dr. Moens, CVC expert witness, italics in brief].

In addition, CVC's brief sets forth its evidence that "[m]ultiple lab groups used CVC's system with only ordinary skill and routine techniques," as well as testimony from several references regarding expectations of those skilled in the art, as further evidence of complete conception (as well as reiterating its argument that Broad's efficient reduction to practice is actually evidence supporting CVC's complete conception).  Specifically CVC argues:

The PTAB may not ignore the copious objective evidence showing that CVC and the rest of the field understood the alleged "problem" and knew how to solve it.  . . .  That neither CVC nor others encountered "perplexing intricate difficulties arising every step of the way" or "unduly extensive research or experimentation" when applying CVC's sgRNA CRISPR-Cas9 system in eukaryotic cells confirms the completeness of CVC's 22 conception [citations omitted].

And the existence of some failures in attempts to practice eukaryotic CRISPR is "irrelevant," according to CVC, because "[t]he law does not require a 100% success rate for attempts at reduction to practice" and "[i]n fact, the law of conception does not require any success rate for reductions to practice."

CVC also argues that, with regard to its priority motion granted by the Board regarding it P3 priority application, Broad had not argued a lack of diligence in "August, October, and November 2012, and through CVC's constructive reduction to practice in January 2013," but rather had focused these arguments on March and April 2012.  These dates are "outside the critical period" (i.e., between Broad's conception after CVC's asserted March 1, 2012 date of conception, through CVC's actual or constructive reduction to practice) and thus are unchallenged by Broad according to the brief.

CVC then turns to its legal argument that Broad was attempting to "rewrite conception law" to require a reasonable expectation of success; CVC argues it does not, citing Burroughs Wellcome Co. v. Barr 13 Labs., Inc., 40 F.3d 1223 (Fed. Cir. 1994), and Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 964 F.3d 16 1365, 1372 (Fed. Cir. 2020).  CVC also argues that Broad has mischaracterized Hitzeman v. Rutter, 243 F.3d 1345 (Fed. Cir. 2001), "as requiring both the inventors and a POSA to have a reasonable expectation of success for the inventors to have had a complete conception"; according to CVC, inventors are persons of extraordinary creativity and that the standard is whether here is complete conception in the mind of the inventor rather than a person having ordinary skill in the art.  In any event, CVC argues, its inventors having conceived of and actually reduced to practice the sgRNA CRISPR system "as a pre-formed RNP complex outside of a cell and had a way of delivering the complex into a eukaryotic cell via microinjection" settles the argument.  And if there is any dispute whether CVC's inventors expected CRISPR to be operable in eukaryotic cells, the brief cites contemporaneous statements from both Dr. Doudna and Dr. Charpentier asserting that they did.  The brief also counters Broad's arguments that persons of ordinary skill in the art doubted utility of CRISPR in eukaryotic cells by testimony from witnesses "Raible, Sontheimer, Barrangou, and Marraffini."  Finally, the brief asserts that the purported difficulties of eukaryotic CRISPR did not exist because those impediments would arise (if they did) for protein-mediated methods, whereas CRISPR was fundamentally an RNA-mediated protocol.

Finally regarding CVC's second basis for the Board to render a decision in its favor on priority, the brief notes its several corroborated instances of actual reduction to practice:  in zebrafish on August 9, 2012 and mammalian cells in October and November 2012.

As to the third reason for prevailing, derivation, CVC reiterates its evidence and argument that Broad's inventors derived eukaryotic CRISPR from CVC's inventors, specifically with regard to sgRNA embodiments.  The basis for this argument is the testimony by Dr. Marraffini in his deposition regarding his role as a confidential reviewer of a draft paper that eventually published as the Jinek reference; that Dr. Marraffini attended a scientific conference during which CVC's inventor disclosed this embodiment for use in eukaryotic CRISPR; that Dr. Marraffini appreciated its significance; and that he transmitted this information to the Broad inventors.  An important aspect of these allegations is that, according to CVC, Broad's inventor was unaware of the functional significance of the tracr RNA component of the CRISPR-Cas9 complex until Dr. Marraffini informed him of the sgRNA-containing embodiments.  This evidence compels the Board to grant judgment to CVC in this interference according to the brief.

In conclusion, CVC asserts:

The law rewards inventors, such has CVC, not those who merely derive and then reduce to practice using ordinary skill.  The CVC inventors, not Zhang, invented the subject matter of Count 1.  Whether applying priority of invention law or derivation law, the PTAB should recognize what the scientific community recognized in awarding the Nobel Prize to Charpentier and Doudna: it was their teamwork that made the tremendous scientific leap forward to allow the world to reap the benefits of a single-guide RNA CRISPR-Cas9 system for genome editing in eukaryotes.  The extensive corroborated evidence of record shows this to be the case, and the PTAB should award priority to CVC.