`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`GENEDX, INC.
`Petitioner
`v.
`MYRIAD GENETICS, INC.
`Patent Owner
`
`U.S. Patent No. 6,051,379 to Lescallett et al.
`Issue Date: April 18, 2000
`Title: Cancer Susceptibility Mutations of BRCA2
`_____________________
`
`Inter Partes Review No: Unassigned
`_____________________
`
`GENEDX, INC.'S EXHIBIT LIST
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`GeneDx Exhibit List
`Petition for Inter Partes Review of USPN 6,051,379
`
`Description
`
`GDX
`Exhibit #
`1001 U.S. Patent No. 6,051,379, issued April 18, 2000
`1002 Declaration of Dr. Madhuri Hegde, PH.D., FACMG
`1003 Curriculum Vitae of Dr. Madhuri Hegde, PH.D., FACMG
`1004
`File History of U.S. Patent No. 6,051,379
`1005 Miki, Y., et al., "Mutation analysis in the BRCA2 gene in primary breast
`cancers," Nature Genetics 13: 245-247 (June 13, 1996)
`1006 Bowcock, A.M., "Molecular cloning BRCA1: a gene for early onset
`familial breast and ovarian cancer," Breast Cancer Research and
`Treatment 28: 121-135 (1993)
`1007 Hacia, J.G., et al., "Detection of heterozygous mutations in BRCA1
`using high density oligonucleotide arrays and two-colour fluorescence
`analysis," Nature Genetics 14: 441-447 (December 14, 1996)
`1008 Grompe, M., "The rapid detection of unknown mutations in nucleic
`acids," Nature Genetics 5: 111-117 (1993)
`1009 Orita, M., et al., "Detection of polymorphisms of human DNA by gel
`electrophoresis as single-strand conformation polymorphisms," PNAS
`USA 86: 2766-2770 (1989)
`Scharf, S. J., et al., "Direct Cloning and Sequence Analysis of
`Enzymatically Amplified Genomic Sequences," Science 233: 1076-1078
`(1986)
`1011 Weber, B.H.F., et al., "A Somatic Truncating Mutation in BRCA2 in a
`Sporadic Breast Tumor," Am. J. Hum. Genet. 59: 962-964 (October
`1996)
`Lancaster, J.M., et al., "BRCA2 mutations in primary breast and ovarian
`cancers," Nature Genetics 13: 238-240 (June 13, 1996)
`from
`downloaded
`1013 Myriad Genetics
`2013 Annual Report
`http://files.shareholder.com/downloads/MYGN/3399011197x0x699241/
`42B88246-0E90-4F5C-9697-3DF98027C46D/2013_Annual_Report.pdf
`Declaration of Dr. Gregory C. Critchfield, filed December 23, 2009, in
`Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, No.
`09-cv-04515-RWS (S.D.N.Y.)
`1015 Declaration of Mark Allan Kay, M.D., Ph.D, filed August 31, 2013, in
`University of Utah Research Foundation v. Ambry Genetics Corp., No.
`13-cv-00640-RJS (D.Utah)
`
`1010
`
`1012
`
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`1014
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`- 1 -
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`
`GeneDx Exhibit List
`Petition for Inter Partes Review of USPN 6,051,379
`
`GDX
`Exhibit #
`
`1016
`
`1017
`
`
`1018
`
`1019
`
`Description
`Eng, C., et al., "Interpreting epidemiological research: blinded
`comparison of methods used to estimate the prevalence of inherited
`mutations in BRCA1," J. Med. Genet. 38: 824-833 (2001)
`Sambrook, J., et al., Molecular Cloning, A Laboratory Manual, 2nd Ed.,
`Cold Spring Harbor Laboratory Press, §§ 5.28-5.32, 6.36-6.48, 13.6-
`13.77, and 14.5-14.21 (1989)
`Conner, B.J., et al., "Detection of sickle cell βS-globin allele by
`hybridization with synthetic oligonucleotides," PNAS USA 80: 278-282
`(1983)
`Teng, D.H.F., et al., "Low incidence of BRCA2 mutations in breast
`carcinoma and other cancers," Nature Genetics 13: 241-244 (June 13,
`1996)
`1020 Cotton, R.G.H., "Current methods of mutation detection," Mutation
`Research 285: 125-144 (1993)
`1021 Handelin, B., et al., "Simultaneous Detection of Multiple Point
`Mutations Using Allele-Specific Oligonucleotides," Current Protocols
`in Human Genetics Suppl. 6: 9.4.1-9.4.8, online publication of May 1,
`2001 corresponding to August 1995 print publication
`1022 Wooster, R., et al., "Localization of a Breast Cancer Susceptibility
`Gene, BRCA2, to Chromosome 13q12-13," Science 265: 2088-2090
`(1994)
`1023 Wooster, R., et al., "Identification of the breast cancer susceptibility
`gene BRCA2," Nature 378:789-792 (1995)
`Schutte, M., et al., "Identification by representational difference analysis
`of a homozygous deletion in pancreatic carcinoma that lies within the
`BRCA2 region," Proc. Natl. Acad. Sci. USA 92: 5950-5954 (1995)
`1025 Alberts, et al. "Molecular Biology of the Cell," 3rd Ed., pp. 98-99, 104-
`106, 242-243, 292-293, 314-317, 337, 339, 1072-1073, G-5-G-6, G-10,
`G-17 (1994)
`Tavtigian, S.V., et al., "The complete BRCA2 gene and mutations in
`chromosome 13q-linked kindreds," Nature Genetics 12: 333-337 (March
`12, 1996)
`1027 GenBank Accession No. U43746, "Human breast cancer susceptibility
`(BRCA2) mRNA, complete cds," modification date of September 3,
`1996, available at
`http://www.ncbi.nlm.nih.gov/nuccore/1161383?sat=13&satkey=655953
`2 (last accessed August 6, 2014)
`
`1024
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`1026
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`- 2 -
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`
`GeneDx Exhibit List
`Petition for Inter Partes Review of USPN 6,051,379
`
`Description
`
`GDX
`Exhibit #
`1028 GenBank Accession No. AAB07223, "BRCA2 [Homo sapiens],"
`modification date of September 3, 1996, available at
`http://www.ncbi.nlm.nih.gov/protein/1161384?sat=13&satkey=6559532
`(last accessed August 6, 2014)
`Shattuck-Eidens et al., "In Vivo Mutations and Polymorphisms in the
`17q-linked Breast and Ovarian Cancer Susceptibility Gene," WO
`96/05306 (filed August 11, 1995; published on February 22, 1996)
`PACER List of Associated Cases for 14-md-02510, available at
`https://ecf.utd.uscourts.gov/cgi-bin/qryAscCases.pl?89779 (last accessed
`on August 15, 2014)
`
`1029
`
`1030
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
` /Eldora L. Ellison/
`Eldora L. Ellison (Reg. No. 39,967)
`Lead Attorney for Petitioner GENEDX, Inc.
`
`
`
`
`Date: August 18, 2014
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 New York Avenue, N.W.
`Washington, D.C. 20005-3934
`(202) 371-2600
`
`1889247_1.DOCX
`
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`- 3 -
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`The undersigned hereby certifies that the above-captioned "GENEDX, Inc.'s
`
`Exhibit List" and Exhibits 1001 – 1030 were served in their entirety on August 18,
`
`2014, upon the following party via FEDEX:
`
`MORGAN LEWIS & BROKIUS, LLP
`1111 Pennsylvania Avenue, N.W.
`WASHINGTON DC 20004
`Patent owner's correspondence address
`of record for U.S. Patent No. 6,051,379
`
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
` /Eldora L. Ellison/
` Eldora L. Ellison (Reg. No. 39,967)
`Date: August 18, 2014
` Lead Attorney for Petitioner GENEDX, Inc.
`
`
`
`
`
`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
`(202) 371-2600
`
`
`
`
`