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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`GENEOSCOPY, INC.,
`Petitioner,
`
`v.
`
`EXACT SCIENCES CORPORATION,
`Patent Owner.
`
`
`
`U.S. Patent 11,970,746
`
`
`DECLARATION OF BRENDAN T. JONES
`
`
`
`
`
`
`
`
`
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`
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`Geneoscopy Exhibit 1083, Page 1
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`
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`1. I am an attorney at Foley Hoag LLP, and counsel of record for Geneoscopy,
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`Inc. in the above-captioned matter. I am registered to practice before the United
`
`States Patent and Trademark Office.
`
`2. Attached as EX1001 is a true and correct copy of U.S. Patent No.
`
`11,970,746.
`
`3. Attached as EX1004 is a true and correct copy of Konstanze Lenhard et al.,
`
`“Analysis of Promoter Methylation in Stool: A Novel Method for the Detection of
`
`Colorectal Cancer,” Clinical Gastroenterology and Hepatology, 3:142-149 (2005)
`
`available at https://www.cghjournal.org/article/S1542-3565(04)00624-X/fulltext.
`
`4. Attached as EX1005 is a true and correct copy of Alex Vilkin et al.,
`
`“Performance Characteristics and Evaluation of an Automated-Developed and
`
`Quantitative, Immunochemical Fecal Occult Blood Screening Test,” American
`
`Journal of Gastroenterology, 100:2519-2525 (2005) available at
`
`https://journals.lww.com/ajg/abstract/2005/11000/performance_characteristics_and
`
`_evaluation_of_an.26.aspx.
`
`5. Attached as EX1006 is a true and correct copy of Steven Itzkowitz et al.,
`
`“Improved Fecal DNA Test for Colorectal Cancer Screening,” Clinical
`
`Gastroenterology and Hepatology, 5:111-117 (2007) available at
`
`https://www.cghjournal.org/article/S1542-3565(06)01044-5/fulltext.
`
`1
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`Geneoscopy Exhibit 1083, Page 2
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`
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`6. Attached as EX1007 is a true and correct copy of U.S. Patent Publication
`
`No. US2006/0216714.
`
`7. Attached as EX1008 is a true and correct copy of International Patent
`
`Application No. WO2005/113769.
`
`8. Attached as EX1009 is a true and correct copy of International Patent
`
`Application Publication No. WO97/25925.
`
`9. Attached as EX1010 is a true and correct copy of Dorothy Melvin and
`
`Marion Brooke, “Laboratory Procedures for the Diagnosis of Intestinal Parasites”,
`
`U.S. Department of Health and Human Services Centers for Disease Control
`
`(1982).
`
`10. Attached as EX1011 is a true and correct copy of Takashi Nishikawa et al.,
`
`“A Simple Method of Detecting K-Ras Point Mutations in Stool Samples for
`
`Colorectal Cancer Screening Using One-Step Polymerase Chain
`
`Reaction/Restriction Fragment Length Polymorphism Analysis,” Clinica Chimica
`
`Acta, 318:107–112 (2002) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0009898101008063.
`
`11. Attached as EX1012 is a true and correct copy of Nadie Kutzner et al.,
`
`“Non-Invasive Detection of Colorectal Tumours by the Combined Application of
`
`Molecular Diagnosis and the Faecal Occult Blood Test,” Cancer Letters, 229:33-
`
`2
`
`Geneoscopy Exhibit 1083, Page 3
`
`
`
`41 (2005) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0304383504009796.
`
`12. Attached as EX1013 is a true and correct copy of Bernard Levin et al.,
`
`“Screening and Surveillance for the Early Detection of Colorectal Cancer and
`
`Adenomatous Polyps, a Joint Guideline from the American Cancer Society, the US
`
`Multi-Society Task Force on Colorectal Cancer, and the American College of
`
`Radiology,” Gastroenterology, 134:1570–1595 (2008) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0016508508002321.
`
`13. Attached as EX1014 is a true and correct copy of U.S. Provisional Patent
`
`Application US61/149,581.
`
`14. Attached as EX1015 is a true and correct copy of the transmittal notice for
`
`U.S. Provisional Patent Application US61/149,581.
`
`15. Attached as EX1016 is a true and correct copy of the LinkedIn profile of
`
`Dr. Joost Louwagie as obtained from https://www.linkedin.com/in/joost-
`
`louwagie/?originalSubdomain=ch on January 10, 2024.
`
`16. Attached as EX1017 is a true and correct copy of Recorded Assignment of
`
`US Patent No. 11,634,781 dated April 25, 2017.
`
`17. Attached as EX1018 is a true and correct copy the USPTO Nonfinal Office
`
`Action, dated July 6, 2023.
`
`3
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`Geneoscopy Exhibit 1083, Page 4
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`
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`18. Attached as EX1019 is a true and correct copy of the Response to the
`
`USPTO Nonfinal Office Action filed on October 26, 2023.
`
`19. Attached as EX1020 is a true and correct copy of is a true and correct copy
`
`of GP Young et al., “New Stool Screening Tests for Colorectal Cancer,” Digestion,
`
`76:26-33 (2007) available at https://karger.com/dig/article-
`
`abstract/76/1/26/105075/New-Stool-Screening-Tests-for-Colorectal-Cancer.
`
`20. Attached as EX1021 is a true and correct copy of Lydia Guittet et al.,
`
`“Comparison of A Guaiac Based And An Immunochemical Faecal Occult Blood
`
`Test In Screening For Colorectal Cancer In A General Average Risk Population,”
`
`Gut, 56:210-214 (2007) available at https://gut.bmj.com/content/56/2/210.short.
`
`21. Attached as EX1022 is a true and correct copy of Jeff Olson et al., “DNA
`
`Stabilization is Critical for Maximizing Performance of Fecal DNA-Based
`
`Colorectal Cancer Tests,” Diagnostic Molecular Pathology, 3:183-191 (2005)
`
`available at
`
`https://journals.lww.com/molecularpathology/abstract/2005/09000/dna_stabilizatio
`
`n_is_critical_for_maximizing.11.aspx.
`
`22. Attached as EX1023 is a true and correct copy of N. Hoepffner et al.,
`
`“Comparative Evaluation of a New Bedside Faecal Occult Blood Test in a
`
`Prospective Multicentre Study,” Alimentary Pharmacology & Therapeutics,
`
`4
`
`Geneoscopy Exhibit 1083, Page 5
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`
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`23:145-154 (2006) available at
`
`https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2036.2006.02702.x.
`
`23. Attached as EX1024 is a true and correct copy of Jordan Nechvatal et al.,
`
`“Fecal Collection, Ambient Preservation, and DNA Extraction for PCR
`
`Amplification of Bacterial And Human Markers from Human Feces,” Journal of
`
`Microbiological Methods, 72(2):124-32 (2008) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0167701207003843.
`
`24. Attached as EX1025 is a true and correct copy the article, "FDA Approves
`
`Exact Sciences' Cologuard; First and Only Stool DNA Noninvasive Colorectal
`
`Cancer Screening Test", PR NEWSWIRE, dated August 12, 2014 available at
`
`https://investor.exactsciences.com/investor-relations/press-releases/press-release-
`
`details/2014/FDA-Approves-Exact-Sciences-Cologuard-First-and-Only-Stool-
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`DNA-Noninvasive-Colorectal-Cancer-Screening-Test/default.aspx.
`
`25. Attached as EX1026 is a printout of Exact Sciences Corporation’s "Patents
`
`and Trademarks" webpage at https://www.exactsciences.com/patents-and-
`
`trademarks/ as visited on August 9, 2024.
`
`26. Attached as EX1027 is printout of Exact Sciences Corporation’s "Patents
`
`and Trademarks" webpage, dated December 6, 2014, downloaded from Wayback
`
`Machine at
`
`5
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`Geneoscopy Exhibit 1083, Page 6
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`
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`https://web.archive.org/web/201406015245/http//www.exactsciences.com/patents-
`
`and-trademarks/ on August 9, 2024.
`
`27. Attached as EX1028 is a true and correct copy of U.S. Patent No.
`
`9,163,278.
`
`28. Attached as EX1029 is a true and correct copy of the Response to USPTO
`
`Nonfinal Office Action filed on July 31, 2015.
`
`29. Attached as EX1030 is a true and correct copy of U.S. Patent No.
`
`11,634,781.
`
`30. Attached as EX1031 is a true and correct copy of Geneoscopy, Inc.’s
`
`Petition filed in IPR2024-00459.
`
`31. Attached as EX1032 is a true and correct copy of Exact Sciences
`
`Corporation’s Preliminary Response filed in IPR2024-00459.
`
`32. Attached as EX1033 is a true and correct copy of the Patent Trial and
`
`Appeal Board’s Institution Decision in IPR2024-00459.
`
`33. Attached as EX1034 is a true and correct copy of JB Simon, “Occult Blood
`
`Screening for Colorectal Carcinoma: A Critical Review,” Gastroenterology,
`
`88:820-837 (1985).
`
`34. Attached as EX1035 is a true and correct copy of D. Sidransky,
`
`“Identification of Ras Oncogene Mutations in the Stool of Patients with Curable
`
`6
`
`Geneoscopy Exhibit 1083, Page 7
`
`
`
`Colorectal Tumors,” Science, 256:102–105 (1992) available at
`
`https://www.science.org/doi/abs/10.1126/science.1566048.
`
`35. Attached as EX1036 is a true and correct copy of Hannes Müller et al.,
`
`“Methylation Changes in Faecal DNA: A Marker for Colorectal Cancer
`
`Screening?” Lancet, 63:1283-1285 (2004) available at
`
`https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)16002-
`
`9/abstract.
`
`36. Attached as EX1037 is a true and correct copy of Kornel Schuebel et al.,
`
`“Comparing the DNA Hypermethylome with Gene Mutations in Human Colorectal
`
`Cancer,” PLoS Genet. 3:1709–1723 (2007) available at
`
`https://journals.plos.org/plosgenetics/article?id=10.1371/journal.pgen.0030157.
`
`37. Attached as EX1038 is a true and correct copy of Lanlan Shen, et al.,
`
`“Integrated Genetic and Epigenetic Analysis Identifies Three Different Subclasses
`
`of Colon Cancer,” Proc Natl. Acad. Sci. U.S.A. 104(47): 18654–18659 (2007)
`
`available at https://www.pnas.org/doi/abs/10.1073/pnas.0704652104.
`
`38. Attached as EX1039 is a true and correct copy of Tagore, K.S., et al.,
`
`“Review Article: the Evolution to Stool DNA Testing for Colorectal Cancer,”
`
`Aliment Pharmacol. Ther. 19: 1225-1233 (2004) available at
`
`https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2036.2004.02005.x.
`
`7
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`Geneoscopy Exhibit 1083, Page 8
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`
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`39. Attached as EX1040 Rennert et al., “Detecting K-Ras Mutations in Stool
`
`from Fecal Occult Blood Test Cards in Multiphasic Screening for Colorectal
`
`Cancer,” Cancer Letters, 253:258-264 (2007) available at
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`https://www.sciencedirect.com/science/article/abs/pii/S0304383507000420.
`
`40. Attached as EX1041 is a true and correct copy of U.S. Patent No.
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`5,198,365.
`
`41. Attached as EX1042 is a true and correct copy of Thomas Imperiale et al.,
`
`“Fecal DNA Versus Fecal Occult Blood for Colorectal-Cancer Screening in an
`
`Average-Risk Population,” New England Journal Medicine, 351(26): 2704-2714
`
`(2004) available at https://www.nejm.org/doi/full/10.1056/NEJMoa033403.
`
`42. Attached as EX1043 is a true and correct copy of David Ahlquist et al.,
`
`“Stool DNA and Occult Blood Testing for Screen Detection of Colorectal
`
`Neoplasia,” Annals of Internal Medicine, 149(7): 441–W81 (2008).
`
`43. Attached as EX1044 is a true and correct copy of G.P. Young, “Fecal
`
`Immunochemical Tests (FIT) vs. Office-Based Guaiac Fecal Occult Blood Test
`
`(FOBT),” Practical Gastroenterology, 28(6): 46-56 (2004) available at
`
`https://www.acpjournals.org/doi/abs/10.7326/0003-4819-149-7-200810070-00004.
`
`44. Attached as EX1045 is a true and correct copy of Karl, et al., Improved
`
`Diagnosis of Colorectal Cancer Using a Combination of Fecal Occult Blood and
`
`Novel Fecal Protein Markers,” Clinical Gastroenterology and Hepatology,
`
`8
`
`Geneoscopy Exhibit 1083, Page 9
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`
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`6:1122–1128 (2008) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S1542356508003455.
`
`45. Attached as EX1046 is a true and correct copy of Victoria White and
`
`Richard Miller, “Colorectal Cancer: Prevention and Early Diagnosis,” Medicine,
`
`35(6) 297-301 (2007) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S1357303907000758.
`
`46. Attached as EX1047 is a true and correct copy of Suzanne Mahon,
`
`“Prevention and Screening of Gastrointestinal Cancers,” Seminars in Oncology
`
`Nursing, 25(1): 15-31 (2009) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0749208108000788.
`
`47. Attached as EX1048 is a true and accurate copy of U.S. Patent No.
`
`9,891,223.
`
`48. Attached as EX1049 is a true and correct copy of Donald Ostrow, “Tests for
`
`Fecal Occult Blood, in Clinical Methods: The History, Physical, and Laboratory
`
`Examinations.” Boston: Butterworths; Chapter 98 (1990) available at
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`https://www.ncbi.nlm.nih.gov/books/NBK445/.
`
`49. Attached as EX1050 is a true and correct copy of U.S. Patent No.
`
`7,195,878.
`
`50. Attached as EX1051 is a true and correct copy of Charles Kahi et al.,
`
`“Screening, Surveillance, and Primary Prevention for Colorectal Cancer: A Review
`
`9
`
`Geneoscopy Exhibit 1083, Page 10
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`
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`of the Recent Literature,” Gastroenterology, 135: 380-399 (2008) available at
`
`https://www.gastrojournal.org/article/S0016-5085(08)00969-4/fulltext.
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`51. Attached as EX1052 is a true and correct copy of H Zou et al., “Highly
`
`Methylated Genes in Colorectal Neoplasia: Implications for Screening,” Cancer
`
`Epidemiol Biomarkers Preview, 16(12):2686-96 (2007) available at
`
`https://aacrjournals.org/cebp/article/16/12/2686/260084/Highly-Methylated-Genes-
`
`in-Colorectal-Neoplasia.
`
`52. Attached as EX1053 is a true and correct copy of Susumu Eguchi et al.,
`
`“Mutations of the P53 Gene in Stool of Patients with Resectable Colorectal
`
`Cancer,” Cancer, 77:1707–1710 (1996) available at
`
`https://acsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/(SICI)1097-
`
`0142(19960415)77:8%3C1707::AID-CNCR43%3E3.0.CO;2-0.
`
`53. Attached as EX1054 is a true and correct copy of E. Villa, et al.,
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`“Identification of Subjects at Risk for Colorectal Carcinoma through a Test Based
`
`on K-Ras Determination in the Stool,” Gastroenterology, 110:1346–1353 (1996)
`
`available at https://www.gastrojournal.org/article/S0016-5085(96)00204-1/fulltext.
`
`54. Attached as EX1055 is a true and correct copy of Boynton et al., “DNA
`
`Integrity as a Potential Marker for Stool-based Detection of Colorectal Cancer,”
`
`Clinical Chemistry, 49:7 1058–1065 (2003) available at
`
`https://academic.oup.com/clinchem/article/49/7/1058/5641839.
`
`10
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`Geneoscopy Exhibit 1083, Page 11
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`
`
`55. Attached as EX1056 is a true and correct copy of J. Milburn Jessup et al.,
`
`“Diagnosing Colorectal Carcinoma: Clinical and Molecular Approaches,” A
`
`Cancer Journal for Clinicians, 47(2):70-92 (1997) available at
`
`https://europepmc.org/article/med/9074487.
`
`56. Attached as EX1057 is a true and correct copy of WD Chen et al.,
`
`“Detection in Fecal DNA of Colon Cancer-Specific Methylation of the
`
`Nonexpressed Vimentin Gene.” Journal of National Cancer Institute, 97:1124-
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`
`https://academic.oup.com/jnci/article/97/15/1124/2521303.
`
`57. Attached as EX1058 is a true and correct copy of Steven Itzkowtiz, “A
`
`Simplified, Noninvasive Stool DNA Test for Colorectal Cancer Detection,”
`
`American Journal of Gastroenterology, 103:2862-2870 (2008) available at
`
`https://journals.lww.com/ajg/abstract/2008/11000/a_simplified,_noninvasive_stool
`
`_dna_test_for.29.aspx.
`
`58. Attached as EX1059 is a true and correct copy of L-C Li and R. Dahiya,
`
`“MethPrimer: Designing Primers for Methylation Pcrs,” Bioinformatics, 18(11):
`
`1427-1431 (2002) available at
`
`https://academic.oup.com/bioinformatics/article/18/11/1427/177964.
`
`59. Attached as EX1060 is a true and correct copy of Shigeru Kanaoka et al.,
`
`“Potential Usefulness of Detecting Cyclooxygenase 2 Messenger RNA in Feces for
`
`11
`
`Geneoscopy Exhibit 1083, Page 12
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`
`
`Colorectal Cancer Screening,” Gastroenterology, 127:422-427 (2004) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0016508504008686.
`
`60. Attached as EX1061 is a true and correct copy of Y. Matsumura and D.
`
`Tarin, “Significance of CD44 Gene Products for Cancer Diagnosis and Disease
`
`Evaluation,” Lancet, 340:1053-1058 (1992) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/014067369293077Z.
`
`61. Attached as EX1062 is a true and correct copy of Y Mastumura et al.,
`
`“Non-Invasive Detection of Malignancy by Identification of Unusual CD44 Gene
`
`Activity in Exfoliated Cancer Cells,” BMJ, 308:619-624 (1994) available at
`
`https://www.bmj.com/content/308/6929/619.abstract.
`
`62. Attached as EX1063 is Wai Leung et al., “Detection of Hypermethylated
`
`DNA or Cyclooxygenase-2 Messenger RNA in Fecal Samples of Patients with
`
`Colorectal Cancer or Polyps,” American Journal Gastroenterology, 102: 1070-
`
`1076 (2007) available at
`
`https://journals.lww.com/ajg/abstract/2007/05000/detection_of_hypermethylated_d
`
`na_or.24.aspx.
`
`63. Attached as EX1064 is a true and accurate copy of Farid Ahmed et al.,
`
`“Transcriptomic Molecular Markers for Screening Human Colon Cancer in Stool
`
`and Tissue,” Cancer Genomics and Proteomics, 4:1-20 (2007) available at
`
`https://cgp.iiarjournals.org/content/4/1/1.short.
`
`12
`
`Geneoscopy Exhibit 1083, Page 13
`
`
`
`64. Attached as EX1065 is a true and correct copy of D.A. Ahlquist et al.,
`
`“Colorectal Cancer Screening by Detection of Altered Human DNA in Stool:
`
`Feasibility of a Multitarget Assay Panel,” Gastroenterology, 119(5):1219-1227
`
`(2000) available at
`
`https://www.sciencedirect.com/science/article/abs/pii/S0016508500895268.
`
`65. Attached as EX1066 is a true and correct copy of D.A. Ahlquist et al.,
`
`“Molecular Stool Screening for Colorectal Cancer. Using DNA Markers May Be
`
`Beneficial, But Large Scale Evaluation is Needed.” BMJ, 29;321(7256):254-5
`
`(2000) available at https://www.bmj.com/content/321/7256/254.short.
`
`66. Attached as EX1067 is a true and correct copy of International Patent
`
`Application Publication No. WO2009/102788.
`
`67. Attached as EX1068 is a true and correct copy U.S. Patent No. 5,741,650.
`
`68. Attached as EX1069 is a true and correct copy of U.S. Patent No.
`
`5,952,178.
`
`69. Attached as EX1070 is a true and correct copy of I Hirata et al., “Usefulness
`
`of Fecal Lactoferrin and Hemoglobin in Diagnosis of Colorectal Diseases,” World
`
`Journal of Gastroenterology, 14;13(10):1569-74 (2007) available at
`
`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4146900/.
`
`70. Attached as EX1071 is a true and correct D.A. Ahlquist et al., “A Stool
`
`Collection Device: The First Step in Occult Blood Testing,” Annals of Internal
`
`13
`
`Geneoscopy Exhibit 1083, Page 14
`
`
`
`Medicine, (108)4:609-612 (1988) available at
`
`https://www.acpjournals.org/doi/abs/10.7326/0003-4819-108-4-609.
`
`71. Attached as EX1072 is a true and correct copy of the online version of
`
`Konstanze Lenhard et al., “Analysis of Promoter Methylation in Stool: A Novel
`
`Method for the Detection of Colorectal Cancer,” Clinical Gastroenterology and
`
`Hepatology, 3:142-149 (2005), obtained from
`
`https://www.cghjournal.org/article/S1542-3565(04)00624-X/fulltext, on January 9,
`
`2024.
`
`72. Attached as EX1073 is a true and correct International Patent Application
`
`Publication No. WO2008/084219.
`
`73. Attached as EX1074 is a true and correct copy of the online version of
`
`Steven Itzkowitz et al., “Improved Fecal DNA Test for Colorectal Cancer
`
`Screening,” Clinical Gastroenterology and Hepatology, 5:111-117 (2007), as
`
`obtained from https://www.cghjournal.org/article/S1542-3565(06)01044-5/fulltext,
`
`on January 9, 2024.
`
`74. Attached EX1075 is a true and correct copy of a December 13, 2006 press
`
`release obtained from
`
`https://www.sciencedaily.com/releases/2006/12/061213104115.htm# on January 9,
`
`2024.
`
`14
`
`Geneoscopy Exhibit 1083, Page 15
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`
`
`75. Attached as EX1076 is a true and correct copy of the Cologuard Patient
`
`Guide available at
`
`https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017C.pdf.
`
`76. Attached as EX1077 is a true and correct copy of Imperiale, et al.,
`
`“Multitarget Stool DNA Testing for Colorectal-Cancer Screening,” The New
`
`England Journal of Medicine, 370(14):1287-1297 (2014) available at
`
`https://www.nejm.org/doi/full/10.1056/NEJMoa1311194.
`
`77. Attached as EX1078 is a true and correct copy of Exact Sciences
`
`Corporation’s 2023 Form 10-K.
`
`78. Attached as EX1079 is a true and correct copy of Exact Science’s webpage
`
`regarding the Cologuard test as obtained from https://www.exactsciences.com/our-
`
`tests/cologuard on August 15, 2024.
`
`79. Attached as EX1080 is a true and correct copy of the Cologuard Physician
`
`Brochure available at
`
`https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017C.pdf.
`
`80. Attached as EX1081 is a true and correct copy of the Cologuard sDNA-
`
`based Colorectal Cancer Screening Test Instructions for Use available at
`
`https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017C.pdf.
`
`81. Attached EX1082 is a true and correct copy of Duncan Whitney Ph.D.’s
`
`Declaration submitted in IPR2024-00459.
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`15
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`Geneoscopy Exhibit 1083, Page 16
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`
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`I declare, under penalty of perjury under the laws of the United States, that the
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`foregoing is true and accurate.
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`
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`Dated:
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` August 20, 2024
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`
`
`/Brendan T. Jones/
`Brendan T. Jones
`Reg. No. 65,077
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`16
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`Geneoscopy Exhibit 1083, Page 17
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