`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`
`
`MYRIAD GENETICS, INC., MYRIAD GENETIC LABORATORIES, INC.,
`BIO-RAD LABORATORIES, INC., and RAINDANCE TECHNOLOGIES, INC.
`
`Petitioners
`
`v.
`
`THE JOHNS HOPKINS UNIVERSITY
`
`Patent Owner
`
`U.S. Patent No. 7,824,889
`
`_________________________
`
`Case No. To be assigned
`
`_________________________
`
`PETITIONERS' EXHIBIT LIST FOR U.S. PATENT NO. 7,824,889
`
`
`
`
`
`
`
`Myriad Exhibit
`Number
`
`Description
`
`IPR of USPN 7,824,889
`Exhibit List
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`
`
`
`Vogelstein et al., "Digital Amplification," U.S. Patent
`No.7,824,889 (filed on Feb. 23, 2007, issued on Nov. 2,
`2010, Ex Parte Reexamination Certificate Issued: October
`31, 2014)
`
`Declaration of Michael L. Metzker, Ph.D.
`
`Curriculum Vitae of Michael L. Metzker, Ph.D.
`
`File History for U.S. Patent No. 6,440,706
`
`File History for U.S. Patent No. 7,824,889
`
`File History for U.S. Patent No. 7,915,015
`
`File History for U.S. Patent No. 8,859,206
`
`Ex Parte Reexamination File History for U.S. Patent No.
`6,440,706
`
`Ex Parte Reexamination File History for U.S. Patent No.
`7,824,889
`
`Ex Parte Reexamination File History for U.S. Patent No.
`7,915,015
`
`U.S. Provisional Patent Application No 60/146,792 (Filed:
`August 2, 1999)
`
`Simmonds et al., Human Immunodeficiency Virus-Infected
`Individuals Contain Provirus in Small Numbers of
`Peripheral Mononuclear Cells and at Low Copy Numbers,
`JOURNAL OF VIROLOGY 64 (2): 864-872 (1990)
`
`Sykes et al., Quantitation of Targets for PCR by Use of
`Limiting Dilution, BIOTECHNIQUES 13(3): 444-449 (1992)
`
`Chapter 6 of PCR: The Polymerase Chain Reaction 67-88,
`Kary B. Mullis, Francois Ferre, and Richard A. Gibbs Eds.
`(1994)
`
`1
`
`
`
`IPR of USPN 7,824,889
`Exhibit List
`
`Description
`
`Brown et al., "Method Of Sampling, Amplifying And
`Quantifying Segment Of Nucleic Acid, Polymerase Chain
`Reaction Assembly Having Nanoliter-Sized Sample
`Chambers, And Method Of Filling Assembly," U.S. Patent
`No. 6,143,496 (filed on April 17, 1997, issued on November
`7, 2000)
`
`Kellogg et al., TaqStart Antibody: 'Hot Start' PCR
`Facilitated by a Neutralizing Monoclonal Antibody Directed
`Against Taq DNA Polymerase, BIOTECHNIQUES 16 (6):1134-
`1136 (1994)
`
`Vogelstein et al., Digital PCR, PROCEEDINGS OF THE
`NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES
`96:9236-9241 (1999)
`
`Monya Baker, Digital PCR hits its stride, NATURE METHODS
`9 (6):541-544 (2012)
`
`Wei et al., Viral dynamics in human immunodeficiency virus
`type 1 infection, NATURE 373:117-122 (1995)
`
`Ho et al., Rapid turnover of plasma virions and CD4
`lymphocyte in HIV-1 infection, NATURE 373:123-126 (1995)
`
`Coffin, HIV population dynamics in vivo: Implications for
`genetic variation, pathogenesis and therapy, SCIENCE
`267:483-489 (1995)
`
`Perelson et al., HIV-1 dynamics in vivo: virion clearance
`rate, infected cell life-span, and viral generation time,
`SCIENCE, 271:1582-1586 (1996)
`
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals,
`Inc., IPR2013-00368, Paper No. 8 at 13 (December 17,
`2013)
`
`2
`
`Myriad Exhibit
`Number
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`
`
`
`
`
`Myriad Exhibit
`Number
`
`Description
`
`IPR of USPN 7,824,889
`Exhibit List
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`
`
`
`Heid et al., Real time quantitative PCR, GENOME RESEARCH
`6:986-994 (1996)
`
`Carteau et al., Chromosome structure and human
`immunodeficiency virus type 1 cDNA integration:
`Centromeric alphoid repeats are a disfavored target,
`JOURNAL OF IMMUNOLOGY 72:4005-4014 (1998)
`
`Ruano et al., Haplotype of multiple polymorphisms resolved
`by enzymatic amplification of single DNA molecules,
`PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF
`THE UNITED STATES 87:6296-6300 (1990)
`
`Sykes et al., Limiting dilution polymerase chain reaction,
`chapter 8 of Reverse Transcriptase PCR, Larrick and Siebert,
`Eds. (1995)
`
`Birch et al., "Nucleic Acid Amplification Using A Reersibly
`(sic) Inactivated Thermostable Enzyme," U.S. Patent No.
`5,677,152 (filed on July 19, 1996, issued on October 14,
`1997)
`
`Birch et al., "Nucleic Acid Amplification Using A
`Reversibly Inactivated Thermostable Enzyme," U.S. Patent
`No. 5,773,258 (filed on July 11, 1996, issued on June 30,
`1998)
`
`Andrew Leigh Brown and Peter Simmonds, Sequence
`analysis of virus variability based on the poymerase (sic)
`chain reaction (PCR), Chapter 11 of 1 HIV: A Practical
`Approach, Jonathan Karn, Ed. (1995)
`
`Complaint, Esoterix Genetic Laboratories, LLC and The
`Johns Hopkins University v. Myriad Genetics, Inc. et al., 16-
`cv-1112, D.I. 1 (M.D.N.C. Sept. 7, 2016)
`
`3
`
`
`
`Myriad Exhibit
`Number
`
`Description
`
`IPR of USPN 7,824,889
`Exhibit List
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`
`
`
`Supplemental Joint Claim Construction Statement, Esoterix
`Genetic Laboratories, LLC and The Johns Hopkins
`University v. Life Technologies Corporation et al., 12-cv-
`1173-CCE-JEP, D.I. 71 (M.D.N.C. Oct. 29, 2013)
`
`Plaintiffs’ Opening Claim Construction Brief, Esoterix
`Genetic Laboratories, LLC and The Johns Hopkins
`University v. Life Technologies Corporation et al., 12-cv-
`1173-CCE-JEP, D.I. 78 (M.D.N.C. Nov. 5, 2013)
`
`'706 Patent File History Excerpt (response to rejection over
`Ruano) [Response to Office Action, July 12, 2001]
`
`'706 Patent Reexamination File History Excerpt (response to
`rejections adding “isolated”) [Response to Final Office
`Action, 7/9/2014]
`
`'206 File History Excerpt (rejection over Ruano)[Final Office
`Action, 6/27/2013]
`
`'206 File History Excerpt (response to rejection over Ruano)
`[Response to Final Office Action, 9/25/2013]
`
`'206 File History Excerpt (response to rejection over
`Simmonds) [Office Action, 10/10/2012]
`
`'206 File History Excerpt (response to rejection over
`Simmonds) [Response to Office Action, 3/11/2013]
`
`Myriad Answer, Affirmative Defenses, and Counterclaims,
`Esoterix Genetic Laboratories, LLC and The Johns Hopkins
`University v. Myriad Genetics, Inc. et al., 16-cv-1112, D.I.
`22 (M.D.N.C. Nov. 2, 2016)
`
`Zimmermann et al., Digital PCR: a powerful new tool for
`noninvasive prenatal diagnosis? PRENATAL DIAGNOSIS
`28:1087-1093 (2008)
`
`4
`
`
`
`Myriad Exhibit
`Number
`
`Description
`
`IPR of USPN 7,824,889
`Exhibit List
`
`'706 Patent Reexamination File History Excerpt (Lapidus
`Declaration) [Response to Office Action, 9/9/2014]
`
`'706 Patent Reexamination File History Excerpt (Shi
`Declaration) [Response to Office Action, 9/9/2014]
`
`'889 Patent File History Excerpt (response to double
`patenting rejection) (Response to Office Action, 4/22/2009]
`
`'015 Patent File History Excerpt (response to double
`patenting rejection) [Response to Office Action, 10/6/2010]
`
`'015 Patent Reexamination File History Excerpt (response to
`rejections adding “isolated”) [Response to Final Office
`Action, 7/9/2014]
`
`Birch et al., Simplified hot start PCR, NATURE 381:445-446
`(1996)
`
`
`
`5
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`
`
`
`
`
`
`
`IPR of USPN 7,824,889
`Exhibit List
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(E), 42.105(A))
`
`The undersigned hereby certifies that the above-captioned "Petitioners'
`
`Exhibit List For U.S. Patent No. 7,824,889" was served in its entirety on March 16,
`
`2017 upon the following parties via Electronic Mail based on prior agreement of
`
`Paul K. Sun, Jr.
`ELLIS &WINTERS LLP
`Post Office Box 33550
`Raleigh, North Carolina 27636
`E-mail: paul.sun@elliswinters.com
`
`
`
`
`
`
`By: /Anne S. Toker/
`Anne S. Toker, Reg. No. 53,692
`Quinn Emanuel Urquhart & Sullivan LLP
`51 Madison Ave, 22nd FL
`New York, NY 10010
`(212) 849-7000
`
`6
`
`the parties.
`
`Katrina M. Quicker
`Jason P. Grier
`BAKER & HOSTETLER LLP
`1170 Peachtree Street, NE, Suite 2400
`Atlanta, GA 30309-7676
`kquicker@bakerlaw.com
`jgrier@bakerlaw.com
`
`Sarah A. Kagan
`Joseph M. Skerpon
`Dale Hoscheit
`Lisa M. Hemmendinger
`1100 13th Street, N.W., Suite 1200
`Washington, DC 20005-4051
`SKagan@bannerwitcoff.com
`Jskerpon@bannerwitcoff.com
`DHoscheit@bannerwitcoff.com
`Lhemmendinger@bannerwitcoff.com
`
`Date: March 16, 2017
`
`
`
`
`
`
`
`
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