Appeal No. 2017-1907 United States Court of Appeals for the Federal Circuit

80 Pages·2017·0.51 MB·English

Case: 17-1907 Document: 28 Page: 1 Filed: 10/25/2017

Appeal No. 2017-1907

United States Court of Appeals
for the Federal Circuit
________________

REGENTS OF THE UNIVERSITY OF CALIFORNIA,
UNIVERSITY OF VIENNA, EMMANUELLE
CHARPENTIER,

Appellants,
v.
THE BROAD INSTITUTE, INC., MASSACHUSETTS
INSTITUTE OF TECHNOLOGY, PRESIDENT AND
FELLOWS OF HARVARD COLLEGE,

Appellees.
________________

Appeal from the United States Patent and Trademark Office,
Patent Trial and Appeal Board in Interference No. 106,048
________________

BRIEF FOR APPELLEES
________________
STEVEN R. TRYBUS RAYMOND N. NIMROD
HARRY J ROPER MATTHEW D. ROBSON
PAUL D MARGOLIS
QUINN EMANUEL URQUHART &
JENNER & BLOCK LLP SULLIVAN, LLP
353 North Clark Street 51 Madison Avenue
Chicago, IL 60654 New York, NY 10010
312-222-9350 212-849-7000

Attorneys for Appellees, Attorneys for Appellee,
The Broad Institute, Inc., The Broad Institute, Inc.
Massachusetts Institute of
Technology, and President and
Fellows of Harvard College
Case: 17-1907 Document: 28 Page: 2 Filed: 10/25/2017

CERTIFICATE OF INTEREST
Counsel for appellees, The Broad Institute, Inc., Massachusetts Institute of
Technology and President and Fellows of Harvard College certifies the following:
1. The full name of every party represented by me is:
The Broad Institute, Inc.
Massachusetts Institute of Technology
President and Fellows of Harvard College
2. The names of the real parties in interest represented by me is:
None
3. All parent corporations and any publicly held companies that own 10
percent or more of the stock of the party or amicus curiae represented by me are:
None
4. The names of all law firms and the partners or associates who
appeared for the parties now represented by me before the Patent Trial and Appeal
Board, or are expected to appear in this Court, are:
Thomas J Kowalski and Deborah L. Lu, Vedder Price, PC

5. The title and number of any case known to counsel to be pending in
this or any other court or agency that will directly affect or be directly affected by
this court’s decision in the pending appeal are:

None

DATE: October 25, 2017 /s/ Steven R. Trybus

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TABLE OF CONTENTS
CERTIFICATE OF INTEREST ............................................................................... ii
Table of Authorities .................................................................................................. vi
TABLE OF ABBREVIATIONS .............................................................................. ix
STATEMENT OF RELATED CASES ..................................................................... 1
JURISDICTIONAL STATEMENT .......................................................................... 1
COUNTER-STATEMENT OF ISSUES ................................................................... 3
INTRODUCTION ..................................................................................................... 4
COUNTER-STATEMENT OF THE CASE ........................................................... 11
I. THE DEVELOPMENT OF CRISPR FOR EUKARYOTIC GENOME
EDITING ....................................................................................................... 11
A. CRISPR Is a Naturally-Occurring System Present Only in
Prokaryotes (Bacteria and Archaea) .................................................... 11
B. As Early as 2008, Researchers Speculated on the Possibility of
Engineering a CRISPR System to Function in the Different
Environment of Eukaryotic Cells, But No Success Was
Achieved .............................................................................................. 15
C. In February 2011, Broad’s Dr. Feng Zhang Began Engineering
Successful CRISPR-Cas9 Systems to Function in Eukaryotic
Cells ..................................................................................................... 18
II. EXPECTATIONS IN THE ART AFTER PUBLICATION OF THE JINEK
2012 PAPER BY THE UC INVENTORS .................................................... 20
A. The UC Inventors’ In Vitro Experiments and Engineered
Chimeric Molecule .............................................................................. 20
B. Contemporaneous Observations of the UC Inventors and
Skilled Artisans after Publication of the Jinek 2012 Paper ................. 22
C. Attempts to Adapt CRISPR to Eukaryotes by Research Groups
after Jinek 2012 ................................................................................... 24
D. The Enthusiastic Scientific Reaction to the Cong 2013 Article ......... 26
III. THE INTERFERENCE PROCEEDINGS .................................................... 27
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A. UC Requests an Interference Based on the Premise That UC’s
In Vitro CRISPR System Was Readily and Easily Applicable to
Eukaryotic Cells .................................................................................. 27
B. UC’s Proposed Count Is Rejected by the PTAB When It
Institutes the Interference .................................................................... 28
C. UC’s Premise for the Interference Unravels During The
Interference and the PTAB Grants Broad’s Motion 2 Finding
No Interference-in-Fact ....................................................................... 28
SUMMARY OF ARGUMENT ............................................................................... 30
STANDARD OF REVIEW ..................................................................................... 32
ARGUMENT ........................................................................................................... 34
I. SUBSTANTIAL EVIDENCE SUPPORTS THE PTAB’S FACTUAL
FINDING THAT A POSA WOULD NOT HAVE HAD A REASONABLE
EXPECTATION OF SUCCESS ................................................................... 34
A. Category 1: Contemporaneous Statements of the Inventors
Support the PTAB’s Finding ............................................................... 35
B. Category 2: Contemporaneous Statements of UC’s Expert
Support the PTAB’s Finding ............................................................... 38
C. Category 3: Substantial Evidence Relating to Work by
Research Groups after Jinek 2012 Supports the PTAB’s
Finding ................................................................................................. 40
D. Category 4: Substantial Evidence Relating to the Differences
Between Prokaryotic and Eukaryotic Cells Supports the
PTAB’s Finding .................................................................................. 43
E. Category 5: Substantial Evidence Relating to Prior Art
Attempts to Adapt Prokaryotic Systems to Eukaryotes Supports
the PTAB’s Finding............................................................................. 47
II. UC ERRONEOUSLY ASSERTS THAT THE PTAB COMMITTED
LEGAL ERRORS IN ITS INTERFERENCE-IN-FACT ANALYSIS ......... 50
A. UC Erroneously Claims that the PTAB Applied an Incorrect
Legal Standard Requiring Certainty of Success .................................. 51
B. UC Incorrectly Claims that the PTAB Applied a Legal
Standard Requiring Specific Instructions ............................................ 53
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C. UC Incorrectly Asserts the PTAB Committed Legal Error by
Not Considering the Unpublished Kim Application as Prior Art
for the Interference-in-fact Analysis ................................................... 57
1. The Kim Application Is Not Within the Knowledge of a
POSA in 2012 for Purposes of an Interference-in-Fact
Inquiry ....................................................................................... 57
2. The Kim Application Is Not §102(e) Prior Art to Broad’s
Invention in Any Event ............................................................. 60
III. UC INCORRECTLY ASSERTS THAT THE PTAB FAILED TO
CONSIDER CERTAIN EVIDENCE AND ARGUMENTS BELOW ......... 62
A. UC Erroneously Argues that the PTAB Rejected, as a Matter of
Law, Its Argument about Evidence of Simultaneous Invention
and Secondary Considerations ............................................................ 62
3. The PTAB Did Not Fail to Address a Simultaneous
Invention Argument; Rather, UC Did Not Make It .................. 63
4. The PTAB Considered, on the Merits, the Evidence
Relating Other Research Groups in the Context of UC’s
Arguments Below ..................................................................... 64
5. Even if UC Had Raised the Issue of Alleged
Simultaneous Invention, the Argument Would Have Had
No Impact on the PTAB’s Obviousness Analysis .................... 66
B. UC Erroneously Asserts that the PTAB Failed to Consider Prior
Art Dated After December 12, 2012 ................................................... 67
CONCLUSION ........................................................................................................ 69
CERTIFICATE OF SERVICE ................................................................................ 70
CERTIFICATE OF COMPLIANCE ....................................................................... 71

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TABLE OF AUTHORITIES
Page(s)
CASES
Abbott Labs. v. Sandoz, Inc.,
544 F.3d 1341 (Fed. Cir. 2008) .............................................................. 36, 55, 59
Alarm.com v. iControl Networks, Inc.,
2015 WL 1871503 (PTAB Mar. 31, 2015) ........................................................ 62
Ariosa Diagnostics v. Verinata Health, Inc.,
805 F.3d 1359 (Fed. Cir. 2015) .......................................................................... 35
Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
320 F.3d 1339 (Fed. Cir. 2003) .......................................................................... 58
Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
752 F.3d 967 (Fed. Cir. 2014) ............................................................................ 67
CardiAQ Valve Tech. v. NeoVasc,
No. 2017-1302, 2017 WL 3833209 (Fed. Cir. Sept. 1, 2017) ................ 62, 63, 68
Consol. Edison Co. v. NLRB,
305 U.S. 197 (1938) ............................................................................................ 35
Consolo v. Federal Maritime Comm’n,
383 U.S. 607 (1966) ............................................................................................ 35
Eli Lilly & Co. v. Bd. of Regents of Uni. Of Wash.,
334 F.3d 1264 (Fed. Cir. 2003) .......................................................................... 34
Google v. SimpleAir,
682 F. App’x 900 (Fed. Cir. 2017) ..................................................................... 73
Hazeltine Research, Inc. v. Brenner,
382 U.S. 252 (1965) ............................................................................................ 61
In re Bartfield,
925 F.2d 1450 (Fed. Cir. 1991) .......................................................................... 61
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In re Gartside,
203 F.3d. 1305 (Fed. Cir. 2000) ......................................................................... 35
In re Huang,
100 F.3d 135 (Fed. Cir. 1996) ............................................................................ 35
In re Kubin,
561 F.3d 1351 (Fed. Cir. 2009) .................................................................... 46, 51
In re NTP, Inc.,
654 F.3d 1279 (Fed. Cir. 2011) .......................................................................... 38
In re Nuvasive, Inc.,
842 F.3d 1376 (Fed. Cir. 2016) .......................................................................... 73
In re O’Farrell,
853 F.2d 894 (Fed. Cir. 1988) ............................................................................ 51
In re Stepan Co.,
868 F.3d 1342 (Fed. Cir. 2017) .................................................................... 35, 59
In re Warsaw Orthopedic, Inc.,
832 F.3d 1327 (Fed. Cir. 2016) .......................................................................... 35
Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino,
738 F.3d 1337 (Fed. Cir. 2013) .............................................................. 36, 49, 59
KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398 (2007) ...................................................................................... 55, 59
Life Technologies, Inc. v. Clontech Laboratories, Inc.,
224 F.3d 1320 (Fed. Cir. 2000) .......................................................................... 70
Medichem, S.A. v. Rolabo, S.L.,
437 F.3d 1157 (Fed. Cir. 2006). App. ................................................................ 62
NanKwest, Inc. v. Lee,
686 Fed. Appx. 864 (Fed. Cir. 2017) .................................................................. 38
Nat 7 Steel Car, Ltd. v. Canadian Pac. Ry, Ltd.,
357 F.3d 1319 (Fed. Cir. 2004) .......................................................................... 69
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Noelle v. Lederman,
355 F.3d 1343 (Fed. Cir. 2004) ........................................................ 34, 42, 46, 62
PAR Pharm., Inc. v. TWI Pharm., Inc.,
773 F.3d 1186 (Fed. Cir. 2014) .......................................................................... 57
Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348 (Fed. Cir. 2007) .......................................................................... 36
Sage Prods., Inc. v. Devon Indus., Inc.,
126 F.3d 1420 (Fed. Cir. 1997) .......................................................................... 68
Trustees of Columbia Univ. in City of N.Y. v. Illumina, Inc.,
620 Fed. App’x 916 (Fed. Cir. 2015) ................................................................. 70
Velander v. Garner,
348 F.3d 1359 (Fed. Cir. 2003) .............................................................. 41, 51, 57
Wallace v. Dep’t of the Air Force,
879 F.2d 829 (Fed. Cir. 1989) ............................................................................ 72
STATUTES
35 U.S.C. §102 ......................................................................................................... 63
35 U.S.C. §102(e) .............................................................................................passim
35 U.S.C. §102(g) .................................................................................................... 63
35 U.S.C. §256 ......................................................................................................... 62

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TABLE OF ABBREVIATIONS
Parties
UC Regents of the University of California, University of
Vienna, and Emmanuelle Charpentier, collectively
Broad The Broad Institute, Inc., Massachusetts Institute of
Technology, and President and Fellows of Harvard College,
collectively
Patents and
Applications
the ’859 Application Patent Application No. 13/842,859 (UC)
the ’086 Provisional Provisional Patent Application No. 61/652,086 (UC)
the ’527 Provision Provisional Patent Application No. 61/736,527 (Broad)
the Kim Application U.S. Patent Application No. 14/685,568

Defined Terms
PTAB Patent Trial and Appeal Board of the United States Patent
and Trademark Office
PTO United States Patent and Trademark Office
POSA Person of ordinary skill in the art
Jinek 2012 Jinek et al., A programmable dual-RNA-guided DNA
endonuclease in adaptive bacterial immunity, 337(6096)
SCIENCE 816-821 (2012) (Appx04798-04842)
Cong 2013 Cong et al., Multiplex Genome Engineering Using
CRISPR/Cas Systems, 339(6121) SCIENCE 819-823
(2013) with Supplemental Material (Appx04682-04712)
CRISPR Clustered Regularly Interspaced Short Palindromic Repeats
Cas CRISPR associated
crRNA CRISPR RNA
tracrRNA trans-activating crRNA
TALEN Transcription activator-like effector nuclease
ZFN Zinc finger nuclease

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STATEMENT OF RELATED CASES
No other appeal in or from this interference proceeding was previously
before this Court or any other appellate court. Counsel for Appellees are not aware
of any case in this or any other court or agency that will directly affect or be
directly affected by this Court’s decision in this appeal.
JURISDICTIONAL STATEMENT
UC has failed to provide an adequate basis for jurisdiction. UC merely
asserts, without discussion, that this Court has jurisdiction under pre-AIA 28
U.S.C. §1295(a)(4)(A), which relates to appeals from decisions of the PTAB.
However, this Court’s precedent requires UC to set forth its actual injury–in-fact in
order to establish jurisdiction for its appeal, yet UC has failed to do so. Phigenix v.
Immunogen, 845 F.3d 1168, 1175 (Fed. Cir. 2017). That is particularly true here
given that UC has publicly asserted that the PTAB’s decision actually benefitted,
rather than harmed, UC. See, e.g., http://news.berkeley.edu/2017/02/15/berkeley-
statement-regarding-patent-boards-decision-on-crispr-cas9-gene-editing-
technology/ (“We [UC] are pleased that UC’s application, covering the invention
and use of CRISPR gene editing in all cells, can move toward issuance as a U.S.
patent.”). Given this public statement and others like it, UC must set forth its harm
in order to justify its allegation of jurisdiction.
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