By Kevin E. Noonan —

In the latest development in Interference No. 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party The University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"), Broad filed its priority motion (which, as Senior Party they were not obliged to do).

Broad's brief is a hybrid:  on the one hand establishing its dates of conception and actual reduction to practice, and on the other denigrating CVC's claims of conception and reduction to practice.  The latter portion of its argument hinges on two concepts:  first, that eukaryotic applications of CRISPR-Cas9 are governed by the principle of "simultaneous conception and reduction to practice" (a contention for which Broad has the burden of convincing the Patent Trial and Appeal Board), and second, that CVC's admissions prevent them from successfully arguing (as they do in their priority brief) conception followed by acting with diligence to reduce their invention to practice; this contention includes "admission by omission" to the extent, inter alia, that CVC neglected to include their experiments using fish cells from the provisional application, No. 61/716,256, filed October 19, 2012).

The comparison between the two inventive timelines asserted by Broad was set forth in the motion by this graphic:

Broad's brief is explicit, saying "CVC is not entitled to any of its asserted conceptions, all of which allegedly occurred before CVC had any success in eukaryotic cells.  Count 1 specifically requires specific biologic results in a eukaryotic cell for which the CVC inventors could have had no reasonable expectation of success absent successful eukaryotic experiments and thus could have no conception," citing Hitzeman v. Rutter, 243 F.3d 1345, 1358 (Fed. Cir. 2001), and the "law of the case," no doubt a reference to the outcome of the earlier Interference between the parties (No.106,048).  As illustrated in the timeline, Broad asserts an actual reduction to practice on either July 20th or 27th (depending on when Broad's inventors can be found to have "recognized and appreciated [their] success").  These experiments and their results were corroborated, according to the brief, by two witnesses (Dr. Andrew Ellington and Dr. Ronald Breaker) as well as by contemporaneous communications by Dr. Zhang and declarations of other laboratory members (whose status as inventors vel non is in dispute; see "CVC Files Substantive Motion No. 3 (for improper inventorship) and Broad Opposes").  Broad's brief also cites multiple other instances of actual reduction to practice (as illustrated in the timeline).  In contrast, Broad argues that "CVC did not achieve any success until, at the absolute earliest, October 31, 2012" based on the statements synopsized in the illustration for all earlier actual reduction to practice dates asserted by CVC.

In addition, Broad argues that, while not needed, the Board can also consider evidence of Dr. Zhang's earlier conception beginning on June 26, 2012 (although the arguments asserted for this date are accompanied by the same language CVC used for its conceptions, such as "[h]e further reasonably expected" [that his CRISPR system would work in eukaryotic cells], and include assertions of diligence from that time to the asserted actual reduction to practice in July 2012).  Should the Board still consider CVC's evidence for earlier date(s) of conception, Broad's motion argues that "Dr. Zhang's successful eukaryotic experiments with his dual-molecule RNA CRISPR-Cas9 systems, which occurred well before all of CVC's alleged conceptions, should be taken into account"; Broad's relevant insight being that "[t]hese experiments answered the key question of whether a Cas9 system could be engineered to overcome the expected hurdles in eukaryotic cells," and conceding that "the concept of linking already-hybridized RNA using known linking methods would have been routine" (and thus distinguishing Broad's work and arguments about the routine status of reducing CRISPR to eukaryotic cell environment asserted by CVC in their priority motion).

These arguments are supported by several appendices, including a chart showing Broad diligence as Appendix C.

Turning to the legal argument, Broad leads with its argument regarding the "law of the case":  "mere words and in vitro experiments do not provide a reasonable expectation of success in achieving that specific biological result (a functional eukaryotic CRISPR-Cas9 system)."  Properly asserting that "applicable Federal Circuit precedent is clear that to have conception of a count claiming a specific biological result, the inventor must first have a reasonable expectation of success that the claimed result will be achieved," the brief goes on to assert that any "reasonable expectation of success that the claimed result will be achieved" requires that the claimed result actually be achieved.  The motion argument cites in support the situation in Hitzeman v. Rutter, where a party's claimed conception to a count directed to recombinant production of hepatitis B surface antigen (HBsAg) in yeast failed because "[o]ne skilled in the art at the time this application was filed would not have been able to reasonably predict that HBsAg could be expressed by yeast [and done so in particle form]."  Id. at 1357 (emphasis added).  Thus is the parallel established:  according to Broad, the uncertainty in practicing CRISPR in a eukaryotic cell (which was convincing to the Board in deciding the earlier interference between these parties) precludes CVC from depending on its earlier dates of conception, and the Board should recognize Broad's earlier dates of reduction to practice and award priority on that basis.

The brief includes a certain degree of hagiography regarding Dr. Zhang having at least questionable relevance (but understandable in light of CVC's similar citation of the Novel Prize award to their inventors, Jennifer Doudna and Emmanuelle Charpentier).  Much of this history (including a grant proposal submitted in January 2012) certainly indicates Dr. Zhang's early recognition of the possible usefulness of CRISPR in eukaryotic cells and experiments to achieve this result, but none of it is asserted as part of Broad's conception (although citation of these early efforts (prior to April 2012) support Broad's attempts to put their inventors on the same chronological playing field as CVC's inventors).  The brief then tells the story of Dr. Marraffini's contribution (stemming from information he "heard about at a public conference") regarding sg-RNA CRISPR embodiments, establishing the basis for Broad's contention that this date, June 26, 2012 was Dr. Zhang's first conception of an invention corresponding to the Count in the interference) (the brief is also careful to assert that "[b]ecause Dr. Zhang had already engineered CRISPR-Cas9 systems with the analogous dual-molecule RNA CRISPR-Cas9 system to function in eukaryotic cells, he expected on June 26, 2012 when he received the email from Dr. Marraffini that he could successfully implement his engineered CRISPR-hSpCas9 system with a chimeric RNA having a sufficient tracrRNA length for use in eukaryotic cells in a manner analogous to his dual-molecule RNA system").  Broad's motion also seeks to establish that Dr. Zhang (in contrast to CVC's inventors) had a reasoned basis for expecting that "a CRISPR-Cas9 system could be engineered to overcome the major obstacles presented by eukaryotic cells including, for example, chromatin, RNA degradation, toxicity, and successful co-localization in the eukaryotic cellular milieu," this being his earlier successes in practicing the three-molecule variation of CRISPR in eukaryotic cells.  This for Broad establishes conception, wherein "Dr. Zhang had a definite and permanent idea of the complete operative invention of Count 1."

Like in CVC's brief, Broad's motion includes an illustration of the experimental design of the sg-RNA used in these experiments, as described in an e-mail to Dr. Le Cong:

Followed by a description of Dr. Zhang's asserted successful reduction to practice of embodiments of sg-RNA CRISPR in eukaryotic mouse cells on July 20th and 26th.  This success was verified according to the motion on July 31, 2012, showing by comparative sequencing the expected deletion in the target sequence:

These data and experimental results are supported as they must be by collaborative declarations by several non-inventors (at least until the PTAB renders a decision on CVC's misjoinder of inventorship motion).  And with regard to the requirement that an inventor recognize her invention the motion asserts communications from Dr. Zhang as well as the submission of a manuscript to Science on October 5, 2012 containing in a Figure a map of the vector used in the July 2012 experiments:

The motion also asserts multiple additional actual reduction to practice events in August 2012.  These and other experiments were contained, according to Broad, in the "landmark" January 3, 2013 Science publication by Cong et al.

Broad's arguments then provide the Board with a detailed description of the correspondence between its experimental evidence for actual reduction to practice and claim 18 of Broad U.S. Patent No. 8,697,359 or claim 156 of CVC U.S. Patent Application No. 15/981,807, extensively corroborated by non-inventor declarants for experiments conducted in July, August, and September 2012 and the October 5, 2012 Science manuscript.  This Section also includes positive statements about the authors' achievements by Science reviewers (which of course have no legal effect except in support of Broad's assertions of how these experiments would be understood by those of at least ordinary skill in the art).  And the motion again illustrates how Dr. Zhang "recognized and appreciated" his achievement regarding eukaryotic embodiments of CRISPR, from contemporaneous, corroborated statements.

The motion provides further argument regarding earlier conception (June 26, 2012) by Dr. Zhang than the CVC inventors, based on his ability to have a reasonable expectation of success based on earlier successful experiments, something Broad asserts CVC did not have based on experimental failures and negative statements first adduced in the '048 Interference.  The motion also argues that, should the PTAB give credence to CVC's asserted conception date of March 2012 then Dr. Zhang's work prior to March 2012 should also be considered (although any such consideration would need to also take into account Broad's disclosure that sg-RNA embodiments were first considered after the June 26, 2012 communication from Dr. Marraffini).  And these arguments track some of the same resort to "routine techniques" asserted by CVC in support of its priority position.

The motion concludes with assertions of diligence, supported by a log of day-to-day diligence provided in Appendix C of the motion, and that Dr. Zhang did not abandon, suppress, or conceal Broad's invention, based inter alia on the October 5, 2012 Science manuscript and Broad's provisional application filing on December 12, 2012 (which the Board recognized as Broad's earliest priority document; see "PTAB Grants Broad Motion No. 4 for Priority Benefit to U.S. Provisional Application No. 61/736,527").

From all these facts Broad argued it is entitled to priority award in this Interference.

* As a reminder, in an interference, the Junior Party (CVC) bears the burden of showing actual reduction to practice before reduction to practice by the Senior Party (Broad).  Cabilly v. Boss, 55 USPQ2d 1238, 1254-5 (BPAI 2000), citing Boises v. Benedict, 27 F.3d 539, 541-542, 30 USPQ2d 1862, 1864 (Fed. Cir. 1994); 37 C.F.R. §41.121.  This showing must be by a preponderance of the evidence.  Hahn v. Wong, 892 F.2d 1028, 1032, 13 USPQ2d 1313, 1317 (Fed. Cir. 1989), citing Oka v. Youssefyeh, 849 F.2d 581, 7 USPQ2d 1169, 1171 (Fed. Cir. 1988).

The inventor is the party that first reduced the invention to practice, unless the other party can show that they were the first to conceive the invention and exercised reasonable diligence from a time just prior to the other party's conception through their own reduction to practice.  Hitzeman v. Rutter, 243 F.3d 1345, 1353, 58 USPQ2d 1161, 1166 (Fed. Cir. 2001), citing Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1900-01 (Fed. Cir. 1998).  A junior party that shows that she was first to reduce the invention to practice prevails, Hahn v. Wong 892 F.2d at 1317, and a junior party has no obligation to establish diligence in these circumstances, since it is first actual reduction to practice, not the relative diligence of the parties, that carries the junior party's priority burden.  Steinberg v. Seitz, 517 F.2d 1359, 1364, 186 USPQ 209, 213 (CCPA 1975).

Conception is "the formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice."  Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376, 231 U.S.P.Q. 81, 87 (Fed. Cir. 1986), citing  Coleman v. Dines, 754 F.2d 353, 359, 224 USPQ 857, 862 (Fed. Cir. 1985).  Since conception occurs in the mind of the inventor, there must be "corroborating evidence of a contemporaneous disclosure that would enable one of ordinary skill to make the invention."  Burroughs Wellcome, Id. at 1919, citing Coleman v. Dines, 754 F.2d 353, 359, 224 USPQ 857, 862 (Fed. Cir. 1985).  However, conception of a method does not require knowledge that the invention will work for its intended purpose.  Burroughs Wellcome Co. v. Barr Labs, Inc., 40 F.3d 1223, 32 USPQ 2d 1915 (Fed. Cir. 1994).  Relevant to Broad's arguments in their motion, in Burroughs Wellcome, the claims of the patents-in-suit were directed to methods for using AZT for treating AIDS, and the issue was whether the AZT inventors had conceived of the claimed methods before obtaining evidence that AZT could indeed provide an effective treatment for HIV infection.  Id. at 1225.  The Burroughs Wellcome defendants argued that for an invention in an "uncertain or experimental discipline, where the inventor cannot reasonably believe an idea will be operable until some result supports that conclusion," conception occurs only when there is experimental confirmation that the invention works for its intended purpose.  Id. at 1228.  The Federal Circuit was clear, stating: "[b]ut this is not the law.  An inventor's belief that his invention will work or his reasons for choosing a particular approach are irrelevant to conception."  Id., citing MacMillan v. Moffett, 432 F.2d 1237, 1239, 167 U.S.P.Q. 550, 552 (CCPA 1970).  This is sufficient for conception, unless there is evidence of subsequent experimental failure (the argument Broad relies upon in their argument against CVC): "[a] conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor's idea that it is not yet a definite and permanent reflection of the complete invention as it will be used in practice."  Id. at 1229, citing Rey-Bellet v. Engelhardt, 493 F.2d 1380, 1387, 181 U.S.P.Q. 453, 457-58 (CCPA 1974).

Unlike conception, actual reduction to practice in the chemical or biotechnology arts requires that the inventor has reduced to practice an embodiment of the compound that works for its intended purpose.  Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998).  More than the existence of laboratory notebook pages showing an embodiment within the scope of the count must be corroborated for reduction to practice; corroboration that the embodiment was actually made is needed.  Hahn v. Wong, 892 F.2d 1028, 1032, 13 USPQ2d 1313, 1317 (Fed. Cir. 1989).  If the embodiment requires testing to establish its usefulness for its intended purpose, corroborated evidence of such testing is required.  Newkirk v. Lulejian, 825 F.2d 1581, 1582, 3 USPQ2d 1793, 1794 (Fed. Cir. 1987).  When testing is required to determine whether an embodiment of an invention works for its intended purpose, whether a party can sustain its burden of showing actual reduction to practice by a preponderance of the evidence depends on the extent, nature and results of the testing required.  Scott v. Finney, 34 F.3d 1058, 1061, 32 USPQ2d 1115, 1117-8 (Fed. Cir. 1994) , citing Newkirk v. Lulejian, 825 F.2d 1581, 1582, 3 U.S.P.Q.2d 1793, 1794 (Fed. Cir. 1987).

By Kevin E. Noonan —

Last fall the Patent Trial and Appeal Board, in Interference no. 106,115, granted leave to Junior Party The University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") to file a dispositive motion for improper inventorship against Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad").  CVC filed this motion, and Broad has filed its opposition.

CVC set forth the precise relief requested at the outset:  invalidation for improper inventorship of all Broad patents and applications in the interference having misjoinder of inventors, under 35 U.S.C. § 102(f) for patents and applications claiming priority before enactment of the Leahy-Smith America Invents Act and under 35 U.S.C. § 115(a) for patents or applications having priority after this change in U.S. patent law.  In addition, CVC argued that the unnamed inventors' testimony be given no weight.

The principal evidence marshalled in CVC's motion is a declaration by Broad's attorney, the respected N.Y. patent lawyer Thomas Kowalski, submitted to the EPO in relation to the opposition challenge that has led to revocation of several of the Broad's European patents (see "Broad Institute Loses Appeal in European Patent Office, Patents Remain Revoked").  That declaration, which on its face and by its own terms is limited to inventorship determinations made under U.S. law in 2013, purportedly identifies inventors not named as inventors in corresponding U.S. patent filings.  Importantly for Broad's opposition, CVC asserted that "[i]f a patent fails to name all true inventors, then it is invalid unless and until it is corrected," citing Pannu v. Iolab Corp., 155 F.3d 1344, 1350 (Fed. Cir. 1998), and that this is a proper issue to be raised in an interference and if raised must be resolved, citing Schulze v. Green, 136 F.3d 786, 791 (Fed. Cir. 1998).  These allegations were supported by a comparison of inventorship claimed in both venues regarding in particular CRISPR-Cas9 being practiced in eukaryotic cells (and include specifically Dr. Lin, whom CVC has asked for leave to subpoena), and with regard to PCT/US2013/074611.  Certain of the claims in that PCT application have their correspondence to claims in patents in this interference, according to CVC, such as claim 15 of U.S. Patent No. 8,697,359:

15.  An engineered, programmable, non-naturally occurring Type II CRISPR-Cas system that targets and hybridizes to a target sequence of a DNA molecule in a eukaryotic cell.

The motion further noted that this PCT application, besides being in common to this patent also claims priority to Provisional Application No. 61/736,527.  Also included in the motion is a comparison of claim language in this PCT application and several of the patents and applications in this interference.  Inventorship comparisons are set forth in the motion as contained in the table herein below.

The motion also pointed out apparent inconsistencies between a PCT application (PCT/US2013/074790) that names certain inventors (and where corresponding U.S. patents and applications did name these additional inventors) and other U.S. applications in this interference (including U.S. Patents-in-Interference Nos. 8,697,359; 8,945,839; 8,865,406; 8,895,308; and 9,840,713) containing claims reciting these same putatively inventive aspects (co-delivery of sgRNA and Cas9) of CRISPR-Cas9 in eukaryotic cells where these inventors were not named; claim 1 of the '839 patent is recited as an express example:

1.  A CRISPR-Cas system comprising "a) a first regulatory element, operably linked to at least one nucleotide sequence encoding a CRISPR-Cas system guide RNA [and] b) a second regulatory element operably linked to a nucleotide sequence encoding a Type-II Cas9 protein, wherein: components (a) and (b) are located on same or different vectors of the system, . . . ."

Similarly, CVC argued that, although Mr. Kowalski attested that Heidenreich and Swiech made inventive contributions to in vivo applications of CRISPR-Cas9 and they were named as inventors in PCT/US2013/074667, they were not named in corresponding U.S. Patent-in-Interference No. 9,840,713 having similar claims:

Claim 1.  A CRISPR-Cas complex-mediated method for the production of a multicellular genetically modified non-human animal.

Finally, CVC cited PCT/US2013/074691, which claims "Cas9 ortholog design" and which is also claimed in U.S. Patent-in-Interference No. 8,993,233.  Nevertheless, Shalem is named as an inventor in the PCT application but not in the U.S. counterpart.

In addition, CVC noted what may be considered an Interference Catch-22:  the testimony of an inventor is given no weight.  Thus, "the unnamed inventors identified above should not be permitted to serve as corroborating witnesses to Broad's conception, diligence, and reduction to practice," citing Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1170-71 (Fed. Cir. 2006).  Moreover, even should the PTAB find these individuals are not inventors, their testimony should be disallowed, according to CVC, on the basis that they are not "disinterested" corroborating witnesses, under Union Carbide Chem. & Plastics Tech. Corp. v. Shell Oil Co., 308 F.3d 1167, 1189 (Fed. Cir. 2002) (not an interference case).  The basis for this outcome (i.e., if Cong, Platt, Ran, Hsu, Lin, Heidenreich, Swiech, and Shalem are not named inventors on some of the patents or applications in interference) is that they are named inventors in certain provisional applications for other patents or applications involved in this interference.

CVC sets forth the remedy that Broad is expected (and does, vide infra) to assert:  correction under § 41.121(a)(2).  But the Board has discretion whether to permit correction according to CVC:

Previously, under pre-AIA 35 U.S.C. § 116, applicants before the USPTO had to specify that any inventorship error "arose without any deceptive intent."  Pre-AIA 35 U.S.C. § 116.  Even though the "deceptive intent" language has been removed in 35 U.S.C. § 116(c), applicants still have a duty to exercise candor and good faith in all dealings with the USPTO per 37 C.F.R. § 1.56, as acknowledged in Mr. Kowalski's declaration. See MPEP § 2011; see also Bayer Cropscience S.A. v. Synergenta Ltd., Pat. Int. No. 105,255, 2005 WL 3121463 at *4 (B.P.A.I. Aug. 16, 2005) ("The PTO relies, and should be able to rely, upon attorneys registered to practice before it to act in an honest and forthright manner in their dealings with the PTO.").  Therefore, Broad should not be permitted to correct inventorship under either pre-AIA or AIA law because its omission of inventors was not without deceptive intent and was a violation of the duty of candor.  See 37 C.F.R. § 41.128.

From this, CVC makes the leap to allege that the exclusion of these inventors by Broad was intentional and then provides the purported motivation for such intent:  first, that "the fact that the same patent attorneys, Mr. Kowalski and Ms. Law, were directly and closely involved in the prosecution of all these related matters reinforces the conclusion that those omissions were deliberate" (because in his sworn declaration in the EPO, Mr. Kowalski had attested that he "prepared and prosecuted, supervised others in the preparation, filing, and prosecution, and continue such preparation, prosecution and supervision of [Broad's] CRISPR patent applications") and second that this amounted to Broad having "actual knowledge" of the disparities between inventorship claimed before the EPO and the USPTO (this conclusion being supported according to CVC by a sworn declaration by Broad's in-house counsel, Ms. Law).  CVC then contrasts what it argues is the disparity between the representations made to the two patent offices:

CVC's conclusion is that "[b]ecause Mr. Kowalski's declaration was admittedly done at Broad's direction and control to help Broad defend its European patents the Broad may not now disavow Mr. Kowalski's sworn testimony; it is bound by it," citing in support Therasense v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc).

And after noting that "the PTAB has authority to issue sanctions for such misrepresentations," CVC asks the Board to cancel any claims in any of the Broad patents and applications in this interference.

The Broad's responsive motion (contingent on the Board granting CVC's motion) is grounded on the relative ease with which a patentee or applicant can change inventorship, particularly after enactment of the America Invents Act (see "The Disappearance of Deceptive Intent in S. 23") under 37 C.F.R. §§ 1.48, 1.324, and 41.121(a)(2).  This motion contains 14 sets of declarations and other papers required for Broad to change inventorship in U.S. Patent Nos. 8,697,359; 8,697,359; 8,771,945; 8,795,965; 8,865,406; 8,871,445; 8,889,356; 8,895,308; 8,906,616; 8,932,814; 8,945,839; 8,993,233; 8,999,641; and 9,840,713, and U.S. Application No. 14/704,551.  The motion seeks leave for Broad to correct inventorship of the patents and applications involved in this interference under 35 U.S.C. §§ 116 and 256.

But Broad was not conceding that there are any "unnamed" inventors; this motion is contingent and is not to be considered unless the Board disagrees and grants CVC's motion that inventorship has not been properly joined in any or all of these patents or applications.  The motion cited Pannu v. Iolab and 35 U.S.C. § 256 to support their position (and sub silentio rebut CVC's position) regarding the remedy: correction not cancellation.  And Broad asserted that there is no need for it to accede to the existence of any deficiencies in the named inventors for it to request leave to correct any errors that may have arisen as alleged by CVC.

35 U.S.C. § 256(a) reads:

Whenever . . . through error an inventor is not named in an issued patent, the Director may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.

35 U.S.C. § 256(b) reads:

The error of omitting inventors . . . shall not invalidate the patent in which such error occurred if it can be corrected as provided in this section.

And, Broad argued, 37 C.F.R. § 1.324(b) requires only three conditions be met for correction:

(1) a consent statement by each person being added as an inventor and each person currently named as an inventor,
(2) a consent statement from all assignees, and
(3) the appropriate fee.

Broad contended that these requirements are satisfied by the papers contained in Appendices C through O of the motion, comprising statements by all the putatively unnamed inventors and all assignees that they have no objection to the change in inventorship (and authorization to pay any needed fees).  According to Broad, Section 256 is a "savings provision" that permits a patentee to correct improper inventorship without having its claims cancelled.  Citing Pannu, Broad asserted that "[o]nce 'a patentee demonstrates that inventorship can be corrected as provided for in section 256, a district court must order correction of the patent, thus saving it from being rendered invalid.'"  And citing Egenera, Inc. v. Cisco Systems, Inc., 972 F.3d 1367, 1377 (Fed. Cir. 2020), Broad further asserted that "a patent cannot be invalidated if inventorship can be corrected instead."

The Broad further contended that a similar satisfaction of the requirement for changing inventorship in the challenged involved application under 35 U.S.C. § 116(c):

Whenever through error . . . an inventor is not named in an application, the Director may permit the application to be amended accordingly, under such terms as he prescribes.

which is set out in Appendix P according to the Broad's contingent motion.

Importantly, Broad challenged CVC's assertion regarding intent, not (just) by the denial of deceptive intent but in arguing (correctly) that the statutory amendments under the AIA removed the requirement for "no deceptive intent" for correcting inventorship (in patents and applications), citing Egenera for this proposition ("'error' in § 256 includes 'all varieties of mistakes—honest and dishonest—rather than only unintentional inaccuracy'").  (Although the motion did not affirmatively assert the existence of no inequitable conduct, which CVC's reliance on Therasense strongly suggested is their ultimate argument on the inventorship issue.)

Finally, with regard to Dr. Lin, Broad noted that the papers associated with correcting inventorship in the Appendices lack consent from him.  Broad asserted that it had attempted in good faith to obtain consent to no avail, and requested either than the Board suspend the rules under 37 C.F.R. § 1.182 or invoke the Board's own authority to name Dr. Lin as an inventor for any patent or application for which the Board determines he should be properly named.

By Kevin E. Noonan —

At the end of October, in Interference No. 106,115 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC"), the Patent Trial and Appeal Board (PTAB) consented to CVC's request that they file a motion under 37 C.F.R. § 41.156(a) for leave to subpoena discovery from Luciano Marraffini and Shuailiang Lin, neither of whom is a party to this interference.  (Readers may remember that Dr. Marraffini, faculty at The Rockefeller University, was involved in a dispute over inventorship of certain of the Broad's patents that resulted ultimately in some of the European counterparts of these patents to be revoked by the European Patent Office; see "The CRISPR Chronicles — Broad Institute Wins One and Loses One").

CVC filed its motion on November 6th, circumscribed by the contours of the Board's order that its motion (limited to 5 pages) must:

• describe the general relevance of testimony by Dr. Marraffini and Dr. Lin;
• present the basis on which CVC reasonably believes that Dr. Marraffini and Dr. Lin have knowledge of Broad's priority proofs and can refute them;
• outline the scope of the testimony they will be seeking; and
• explain why subpoena is necessary to obtain the testimony of Dr. Marraffini and Dr. Lin and why an attempt to obtain a subpoena will be successful.

CVC's motion was based on the knowledge these witnesses had from their work with Feng Zhang and their prior statements CVC characterized as being "material to Broad's priority proofs [and] that contradict its priority statement allegations."  This testimony, CVC asserts, is in the interest of justice because the Broad is likely not to proffer their testimony and without it "the PTAB's fair assessment of Broad's priority case will be frustrated."

Substantively, CVC asserted that Dr. Marraffini was expected to testify that Dr. Zhang did not conceive of an embodiment falling within the scope of the Count before publication of the Jinek 2012 reference (disclosing CVC's invention).  This testimony would be consistent with assertions CVC made in its priority motion, stating without alleging that Broad derived its invention from CVC's disclosures (formal and otherwise).  The motion further places Dr. Marraffini in collaboration with Dr. Zhang from December 2011 as evidenced by publications and patent applications filed by research teams including Dr. Marraffini and Zhang.

The motion then sets out quotations from Dr. Marraffini attributing development of single-guide RNA embodiments of CRISPR to CVC's inventors ("[t]he Doudna-Charpentier paper [i.e., Jinek (2012)] is when we all learned about single-guide RNA").  The motion characterizes this statement as contradicting Broad's assertion in its priority statement that Dr. Zhang conceived an invention within the scope of the Count prior to publication of the Jinek 2012 reference.  In addition ("[b]ut there is more"), the motion asserts that Dr. Marraffini was named as a co-inventor on several Broad provisional patent applications, including significantly the Zhang provisional that was the subject of the Board's grant of priority benefit (see "PTAB Grants Broad Motion No. 4 for Priority Benefit to U.S. Provisional Application No. 61/736,527"), a status that Broad has acknowledged.  The motion identifies four categories of testimony from Dr. Marraffini:

(1)     his knowledge of Zhang's work on CRISPR-Cas9 systems, particularly the status of that work before publication of Jinek 2012;

(2)     his knowledge of Zhang's failures to conceive and reduce to practice a single-guide RNA CRISPR-Cas9 system;

(3)     his communications with Zhang before the filing of [Application No. 61/736,527] about the use of single-guide RNA in a CRISPR-Cas9 system; and

(4)     related testimony that contradicts Broad's allegations of priority.

CVC recounts for the Board its attempts to obtain this testimony voluntarily and Dr. Marraffini (and his employer The Rockefeller University) refusing to have him testify, and speculates that a recent settlement of an inventorship dispute might have resulted in an agreement between Broad and Rockefeller that Dr. Marraffini not voluntarily testify "against the Broad's interests."  Therefore, CVC argues, the requested subpoena is necessary.

Regarding Dr Lin, CVC attests that, like Dr. Marraffini he is expected to testify that Dr. Zhang had not invented single-guide RNA species of CRISPR-Cas9 prior to publication of the Jinek 2012 reference.  This expectation is based on correspondence between Dr. Lin and Jennifer Doudna from 2015 that:

• "After seeing [the Jinek 2012] in vitro paper, Feng Zhang and Le Cong quickly jumped to the project without letting me know."

• "My lab notebooks, emails, and other files like dropbox or gel pictures recorded every step of the lab's failure process."

• "We did not work it out before seeing [the Jinek 2012] paper.  It is really a pity."

In addition, the motion contends that Dr. Jin prepared a laboratory presentation in June 2012 where he stated that "the lab had been unsuccessful in implementing a CRISPR-Cas9 system in eukaryotes."

Once again, ("[b]ut there is more"), the motion asserts Lin has "direct and personal knowledge of Broad's priority proofs," including use of his laboratory notebook included as exhibits in another witness's (Dr. Sanjana) affidavit.  And as with Dr. Marraffini, Dr. Lin was named as a co-inventor in Zhang's priority Application No. 61/736,527 and in addition Broad has admitted that Dr. Lin is a co-inventor of "certain methods of using CRISPR-Cas9 in eukaryotes."

Consistent with the Board's Order, CVC asserts that Dr. Lin is expected to testify regarding these topics (and that his deposition will be limited to them):

(1) his involvement with Zhang's experiments;

(2) the circumstances surrounding Zhang's first awareness of a single-guide RNA in a CRISPR-Cas9 system;

(3) Zhang's failures in reducing a CRISPR-Cas9 system to practice before learning of the CVC inventors' work; and

(4) related communications between Lin and Zhang concerning such issues.

As with Dr. Marraffini, CVC argues that the subpoena is necessary because Dr. Lin has refused to testify voluntarily.

The motion concludes with a brief recitation of the law regarding the standards for the Board to grant leave to a party for such a subpoena, and that these circumstances warrant it; most importantly CVC asserts that it does not need the Board's authorization, citing Brown v. Braddick, 595 F.2d 961, 967 (5th Cir. 1979) (but noting conflicting precedent).

The Board having granted Broad leave to file an opposition to CVC's motion, the Senior Party did so on December 18th.  Predictably, Broad argued that granting leave to subpoena these witnesses and their purportedly expected testimony would not be in the interests of justice.  But, according to Broad, should the Board grant leave to subpoena these witnesses then Broad should be awarded half of the maximum 7 hours for each deposition.

Broad's rebuttal of CVC's arguments in favor of subpoenaing this testimony is grounded in CVC not satisfying the requirements under 37 C.F.R. § 41.150(c) that in addition to being in the interest of justice CVC had proffered relevant testimony from these witnessed.  In Broad's view, the purported evidence proffered by CVC was duplicative or could be obtained from other witnesses or documentary evidence.

According to Broad, CVC's category 3 evidence can be obtained from a series of e-mails between Drs. Zhang and Marraffini from January through October 2012.  These same e-mails are the source of category 1 and 2 evidence and suffer the same deficiencies with regard to the need for Dr. Marraffini's testimony.  And Broad cites Tropix, Inc. v. Lumigen, Inc., 53 U.S.P.Q.2d 2018 (B.P.A.I. 2000), for the proposition that category 4 testimony is too broad "to show relevance, the interests of justice, or that Dr. Marraffini has any information related to Dr. Zhang's conception and actual reductions to practice as set forth in detail in Broad's Priority Motion."

Broad further argued that "there is no distinction between Dr. Marraffini's statements [cited by CVC] and the evidence Broad is presenting with its Priority Motion" and that his status as a Zhang collaborator is "immaterial."  And Broad asserts that its Priority Motion and the evidence contained therein "confirm that CVC has no legitimate reason for taking the testimony of Dr. Marraffini."

Turning to Dr. Lin, Broad contends that CVC's category 1 evidence — relating to the experiments performed in the Zhang lab — were available from other Broad declarants, particularly because they were members of the Zhang lab as opposed to Dr. Lin's status as a visiting graduate student (nicely supporting an effort to discredit the competence of his testimony).  Similar, according to Broad CVC's category 2 evidence has been presented in Dr. Zhang's declaration, and certain of the e-mails referenced with regard to this evidence were not shared while Dr. Lin was in the Zhang lab.  Broad interprets this statement, ". . . Feng Zhang and Le Cong quickly jumped to the project without letting me know," as evidence that Dr. Lin lacked knowledge.  For CVC's category 3, Broad characterizes the cited statements as being "incredible, after-the-fact assertions that should not open up the record to a fishing expedition through additional discovery" (while noting parenthetically that at the time of these e-mails Dr. Lin was seeking a position in the Doudna lab).  Further casting suspicion on the veracity of Dr. Lin's statements, the opposition cites his biographical blurb as Director of Genome Engineering at Ligandal, Inc. to suggest that contrary to these statements he "again embraced his contributions to CRISPR"

And for category 4, as with Dr. Marraffini Broad asserts that the testimony sought was too broad under Tropix, Inc. v. Lumigen, Inc. for the Board to properly permit CVC to subpoena Dr. Lin.

For all these reasons, Broad asks the Board to deny CVC's motion or, in the alternative, to grant leave for Broad to depose these witnesses equally during the 7-hour deposition period.