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Filed on Behalf of Junior Party Paper No Filed on behalf of Junior Party Paper No. ___ THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, UNIVERSITY OF VIENNA, AND EMMANUELLE CHARPENTIER By: Eldora L. Ellison, Ph.D., Esq. By: Li-Hsien Rin-Laures, M.D., Esq. Eric K. Steffe, Esq. RINLAURES LLC David H. Holman, Ph.D., Esq. 321 N. Clark Street, 5th floor Byron L. Pickard, Esq. Chicago, IL 60654 John Christopher Rozendaal, Esq. Tel. (773) 387-3200; Fax (773) 929-2391 Paul A. Ainsworth, Esq. [email protected] Michael E. Joffre, Ph.D., Esq. STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C. Sandip H. Patel, Esq. 1100 New York Avenue, NW MARSHALL GERSTEIN & BORUN LLP Washington, D.C. 20005 6300 Willis Tower, 233 South Wacker Tel: (202) 371-2600 Drive Fax: (202) 371-2540 Chicago, IL 60606 [email protected] Tel: (312) 474-6300; Fax: (312) 474-0448 [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, UNIVERSITY OF VIENNA, AND EMMANUELLE CHARPENTIER Junior Party (Applications 15/947,680; 15/947,700; 15/947,718; 15/981,807; 15/981,808; 15/981,809; 16/136,159; 16/136,165; 16/136,168; 16/136,175; 16/276,361; 16/276,365; 16/276,368; and 16/276,374), v. THE BROAD INSTITUTE, INC., MASSACHUSETTS INSTITUTE OF TECHNOLOGY, and PRESIDENT AND FELLOWS OF HARVARD COLLEGE Senior Party (Patents 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; 9,840,713; and Application 14/704,551). _________________ Patent Interference No. 106,115 (DK) (Technology Center 1600) CVC Reply 2 (for judgment based on priority) Interference No. 106,115 CVC Reply 2 TABLE OF CONTENTS I. INTRODUCTION ..............................................................................................................1 II. ARGUMENT .....................................................................................................................5 A. CVC had a complete conception before Broad, coupled with CVC’s uncontested reasonably continuous diligence through CVC’s P3 filing in January 2013. ............5 1. Reason 1: CVC had a complete conception of Count 1 evinced by CVC’s specific embodiment of delivering the sgRNA and Cas9 components to human cells using specific expression vectors and transfection .....................................7 2. Reason 2: CVC had a complete conception of Count 1 before June 26, evinced by CVC’s specific embodiment of delivering the sgRNA and Cas9 components to zebrafish cells as a pre-formed sgRNA-Cas9 ribonucleoprotein complex using nuclear microinjection............................................................................ 11 3. Multiple lab groups used CVC’s system with only ordinary skill and routine techniques, further confirming CVC’s conception. .......................................... 16 4. CVC’s reasonably continuous diligence during the critical period through CVC’s P3 filing went unchallenged by Broad ................................................. 18 5. Broad’s attempt to rewrite conception law fails: conception does not require a reasonable expectation of success. ................................................................... 19 6. CVC proved multiple actual reductions to practice of Count 1. ........................ 25 B. Reason 3: CVC prevails under derivation law. ...................................................... 28 III. CONCLUSION ................................................................................................................ 30 APPENDIX 1 – LIST OF EXHIBITS ..................................................................................... 1-1 APPENDIX 2 – STATEMENT OF MATERIAL FACTS ....................................................... 2-1 Broad’s Additional Facts 64 – 200 ........................................................................... 2-14 CVC Additional Facts 201 - 276 .............................................................................. 2-45 i Interference No. 106,115 CVC Reply 2 TABLE OF AUTHORITIES Cases Agilent Tech. Inc. v. Dionex Softron GMBH, Interference 106,087 (PTAB, Feb. 25. 2021) ............................................................................. 18 Alexander v. Williams, 342 F.2d 466 (C.C.P.A. 1965) ................................................................................................... 30 Applegate v. Scherer, 332 F.2d 571 (C.C.P.A. 1964) ......................................................................................... 4, 20, 30 Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223 (Fed. Cir. 1994) .............................................................................1, 4, 5, 9, 20, 22 Coleman v. Dines, 754 F.2d 353 (Fed. Cir. 1985) ........................................................................................... 1, 4, 20 Dana-Farber Cancer Inst., Inc. v. Ono Pharm. Co., 964 F.3d 1365 (Fed. Cir. 2020) ................................................................................................. 20 Field v. Knowles, 183 F.2d 593 (C.C.P.A. 1950) ................................................................................................... 11 Haskell v. Colebourne, 671 F.2d 1362 (C.C.P.A. 1982) ...................................................................................................7 Hedgewick v. Akers, 497 F.2d 905 (C.C.P.A. 1974) ................................................................................................... 30 Hitzeman v. Rutter, 243 F.3d 1345 (Fed. Cir. 2001) ....................................................................................... 4, 20, 21 In re Tansel, 253 F.2d 241 (C.C.P.A. 1958) ....................................................................................................7 MacMillan v. Moffett, 432 F.2d 1237 (C.C.P.A. 1970) ................................................................................................. 30 Meade v. McKirnan, 585 F.2d 504 (C.C.P.A. 1978) ................................................................................................... 30 Mergenthaler v. Scudder, 11 App. D.C. 264 (D.C. Cir. 1897) ........................................................................................ 4, 11 i Interference No. 106,115 CVC Reply 2 Polye v Uhl, 328 F.2d 893 (C.C.P.A. 1964) ................................................................................................... 30 Regents of Univ. Calif. v. Broad Inst., Inc., 903 F.3d 1286 (Fed. Cir. 2018) ................................................................................................. 17 Rey-Bellet v. Engelhardt, 493 F.2d 1380 (C.C.P.A. 1974) ........................................................................... 3, 11, 17, 18, 19 Sewall v. Walters, 21 F.3d 411 (Fed. Cir. 1994) ........................................................................................... 1, 11, 18 Spero v. Ringold, 377 F.2d 652 (C.C.P.A. 1967) .....................................................................................................7 Summers v. Vogel, 332 F.2d 810 (C.C.P.A. 1964) ................................................................................................... 11 Trumbull v. Kirschbraun, 67 F.2d 974 (C.C.P.A. 1933) ................................................................................................ 11,18 ii Interference No. 106,115 CVC Reply 2 1 I. INTRODUCTION 2 The CVC inventors revolutionized the field of genome editing, giving the world a new 3 system capable of cleaving and editing genes in eukaryotic cells. By identifying for the first time 4 the necessary and sufficient components of the Type II CRISPR-Cas9 cleavage complex and 5 further modifying the RNAs into a single-guide (sgRNA) format, the CVC inventors provided a 6 simple, programmable tool for site-specific gene editing in eukaryotic cells. By the time Zhang 7 learned of CVC’s single-guide CRISPR-Cas9 system, the CVC inventors had already conceived 8 multiple specific embodiments of the invention and were diligently working to reduce the 9 invention to practice. 10 Count 1 recites a composition: a system or a eukaryotic cell comprising a sgRNA 11 CRISPR-Cas9 system. Conception of that composition is complete “when the idea is so clearly 12 defined in the inventor's mind that only ordinary skill would be necessary to reduce the invention 13 to practice, without extensive research or experimentation.” Burroughs Wellcome Co. v. Barr 14 Labs., Inc., 40 F.3d 1223 (Fed. Cir. 1994) (citing Sewall v. Walters, 21 F.3d 411 (Fed. Cir. 1994) 15 and Coleman v. Dines, 754 F.2d 353 (Fed. Cir. 1985)). In accordance with that standard, the 16 CVC inventors unquestionably conceived of the invention before Broad’s alleged June 26 17 conception. By then, CVC had already documented at least two specific embodiments that they 18 later reduced to practice: (1) vectors to express the sgRNA and Cas9 protein to cleave the 19 CTLA6 gene in human cells, and (2) a pre-formed sgRNA/Cas9 ribonucleoprotein (RNP) 20 complex that CVC had already demonstrated works in vitro and subsequently simply 21 microinjected into fish cells to cleave DNA. During the critical period, CVC worked diligently 22 to reduce to practice both embodiments of the invention, achieving multiple actual reductions to 23 practice in a matter of months and requiring no further inventive steps.
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