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 11,634,781
`
`DECLARATION OF BRENDAN T. JONES
`
`Geneoscopy Exhibit 1060, Page 1
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`GENEOSCOPY, INC.,
`Petitioner,
`
`v.
`
`EXACT SCIENCES CORPORATION,
`Patent Owner.
`
`U.S. Patent 11,634,781
`
`DECLARATION OF BRENDAN T. JONES
`
`Geneoscopy Exhibit 1060, Page 1
`
`
`
`1. I am an attorney at Foley Hoag LLP, and counsel of record for Geneoscopy,
`
`Inc. in the above-captioned matter. I am registered to practice before the United
`
`States Patent and Trademark Office.
`
`2. 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).
`
`3. Attached as Ex. 1005 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).
`
`4. Attached as Ex. 1006 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).
`
`5. Attached as Ex. 1008 is a true and correct copy of Sarah Derks et al.,
`
`“Promoter Methylation Precedes Chromosomal Alterations in Colorectal Cancer
`
`Development,” Cellular Oncology, 28:247-257 (2006).
`
`6. Attached as Ex. 1010 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).
`
`Geneoscopy Exhibit 1060, Page 2
`
`
`
`7.
`
`Attached as Ex. 1011 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).
`
`8.
`
`Attached as Ex. 1012 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,
`
`229:33-41 (2005).
`
`9.
`
`Attached as Ex. 1013 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).
`
`10. Attached as Ex. 1016 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.
`
`11. Attached as Ex. 1024 is a true and correct copy of GP Young et al.,
`
`“New Stool Screening Tests for Colorectal Cancer,” Digestion, 76:26-33 (2007).
`
`Geneoscopy Exhibit 1060, Page 3
`
`
`
`12. Attached as Ex. 1025 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).
`
`13. Attached as Ex. 1026 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).
`
`14. Attached as Ex. 1029 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,
`
`23:145-154 (2006).
`
`15. Attached as Ex. 1030 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).
`
`16. Attached as Ex. 1033 is a true and correct copy of JB Simon, “Occult
`
`Blood Screening for Colorectal Carcinoma: A Critical Review,” Gastroenterology,
`
`88:820-837 (1985).
`
`Geneoscopy Exhibit 1060, Page 4
`
`
`
`17. Attached as Ex. 1035 is a true and accurate copy of D. Sidransky,
`
`“Identification of Ras Oncogene Mutations in the Stool of Patients with Curable
`
`Colorectal Tumors,” Science, 256:102–105 (1992).
`
`18. Attached as Ex. 1037 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).
`
`19. Attached as Ex. 1038 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).
`
`20. Attached as Ex. 1039 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).
`
`21. Attached as Ex. 1040 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).
`
`22. Attached as Ex. 1041 is a true and correct copy of the abstract of
`
`Sarah Derks et al., “Promoter Methylation Precedes Chromosomal Alterations in
`
`Colorectal Cancer Development,” Cellular Oncology, 28:247-257 (2006), obtained
`
`from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4618222/ on January 9,
`
`2024.
`
`Geneoscopy Exhibit 1060, Page 5
`
`
`
`23. Attached as Ex. 1043 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).
`
`24. Attached as Ex. 1044 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).
`
`25. Attached as Ex. 1045 is a true and correct copy of 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).
`
`26. Attached as Ex. 1047 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, 6:1122–1128 (2008).
`
`27. Attached as Ex. 1048 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).
`
`Geneoscopy Exhibit 1060, Page 6
`
`
`
`28. Attached as Ex. 1050 is a true and correct copy of Charles Kahi et al.,
`
`“Screening, Surveillance, and Primary Prevention for Colorectal Cancer: A Review
`
`of the Recent Literature,” Gastroenterology, 135: 380-399 (2008).
`
`29. Attached as Ex. 1051 is a true and correct copy of Victoria White and
`
`Richard Miller, “Colorectal Cancer: Prevention and Early Diagnosis,” Medicine,
`
`35(6) 297-301 (2007).
`
`30. Attached as Ex. 1052 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).
`
`31. Attached as Ex. 1053 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).
`
`32. Attached as Ex. 1054 is a true and correct copy of E. Villa, et al.,
`
`“Identification of Subjects at Risk for Colorectal Carcinoma through a Test Based
`
`on K-Ras Determination in the Stool,” Gastroenterology, 110:1346–1353 (1996).
`
`33. Attached as Ex. 1055 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).
`
`Geneoscopy Exhibit 1060, Page 7
`
`
`
`34. Attached as Ex. 1056 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).
`
`35. Attached as Ex. 1057 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).
`
`36. Attached as Ex. 1058 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-
`
`1132 (2005).
`
`37. Attached as Ex. 1059 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).
`
`38. Attached as Ex. 1061 is a true and correct copy of Shigeru Kanaoka et
`
`al., “Potential Usefulness of Detecting Cyclooxygenase 2 Messenger RNA in
`
`Feces for Colorectal Cancer Screening,” Gastroenterology, 127:422-427 (2004).
`
`39. Attached as Ex. 1062 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).
`
`Geneoscopy Exhibit 1060, Page 8
`
`
`
`40. Attached as Ex. 1063 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).
`
`41. Attached as Ex. 1064 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).
`
`42. Attached as Ex. 1065 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).
`
`43. Attached as Ex. 1066 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).
`
`44. Attached as Ex. 1068 is a true and correct copy of Suzanne Mahon, “
`
`Prevention and Screening of Gastrointestinal Cancers,” Seminars in Oncology
`
`Nursing, 25(1): 15-31 (2009).
`
`Geneoscopy Exhibit 1060, Page 9
`
`
`
`45. Attached as Ex. 1069 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 (2004).
`
`46. Attached as Ex. 1071 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).
`
`47. Attached as Ex. 1072 is a true and correct D.A. Ahlquist et al., “A
`
`Stool Collection Device: The First Step in Occult Blood Testing,” Annals of
`
`Internal Medicine, (108)4:609-612 (1988).
`
`48. Attached as Ex. 1073 is a true and accurate 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.
`
`49. Attached as Ex. 1074 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).
`
`50. Attached as Ex. 1076 is a true and accurate copy of the online version
`
`of Steven Itzkowitz et al., “Improved Fecal DNA Test for Colorectal Cancer
`
`Geneoscopy Exhibit 1060, Page 10
`
`
`
`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.
`
`51. Attached Ex. 1077 is a true and accurate copy of a December 13, 2006
`
`press release obtained from
`
`https://www.sciencedaily.com/releases/2006/12/061213104115.htm# on January 9,
`
`2024.
`
`I declare, under penalty of perjury under the laws of the United States, that the
`
`foregoing is true and accurate.
`
`Dated:
`
` January 11, 2024
`
`/Brendan T. Jones/
`Brendan T. Jones
`
`Geneoscopy Exhibit 1060, Page 11
`
`
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