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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`GENOME & COMPANY,
`Petitioner,
`
`v.
`
`THE UNIVERSITY OF CHICAGO,
`Patent Owner.
`
`
`Case PGR2019-00002
`
`U.S. Patent No. 9,855,302 B2
`
`
`
`
`DECLARATION OF REEVES GILLIS
`
`Genome Exhibit 1060
`Page 1 of 12
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`
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`
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`I, Reeves Gillis, state and declare as follows:
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`1.
`
`I have prepared this Declaration in response to Patent Owner’s
`
`Objections To Evidence Under 37 C.F.R. § 42.64(b)(1) filed in the above-
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`referenced post grant review of U.S. Patent No. 9,855,302, which I understand will
`
`be served on Patent Owner.
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`2.
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`I am currently a Senior Research Analyst in the Research Services
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`Department at Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. (“Mintz
`
`Levin”), One Financial Center, Boston, Massachusetts 02111.
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`3.
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`I am over 18 years of age and am competent to make this Declaration.
`
`I make this Declaration based on my own personal knowledge.
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`4.
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`I have been employed in the Research Services Department at Mintz
`
`Levin since 2018.
`
`Attachments
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`
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`Exhibit 1004 (Singh)
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`5.
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`Attached as Exhibit A is a true and correct copy of “Bifidobacterium
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`longum, a lactic acid-producing intestinal bacterium inhibits colon cancer and
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`modulates the intermediate biomarkers of colon carcinogenesis,” authored by
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`Jagveer Singh, et al., and published by Oxford Press University in Carcinogenesis,
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`Vol. 18, Issue 4, April 1997, pp. 833-841 (“Singh”). This document has been
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`designated as Ex. 1004 in this post grant review proceeding.
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`1
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`Genome Exhibit 1060
`Page 2 of 12
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`
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`6.
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`Attached as Exhibit B is a true and correct copy of a printout from
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`Oxford Press University’s webpage
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`(https://academic.oup.com/carcin/article/18/4/833/2365110) describing Singh and
`
`
`
`stating that it was published on April 1, 1997.
`
`Exhibit 1005 (Dong)
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`7.
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`Attached as Exhibit C is a true and correct copy of “The role of
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`intestinal Bifidobacteria on immune system development in young rats,” authored
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`by Ping Dong, et al., and published by ScienceDirect (operated by publisher
`
`Elsevier) in Early Human Development, Vol. 86, Issue 1, January 2010, pp. 51-58
`
`(“Dong”). This document has been designated as Ex. 1005 in this post grant
`
`review proceeding.
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`8.
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`Attached as Exhibit D is a true and correct copy of a printout from
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`ScienceDirect’s webpage
`
`(https://www.sciencedirect.com/science/article/abs/pii/S0378378210000046?via%
`
`3Dihub) describing Dong and stating that it was available online on January 27,
`
`2010.
`
`Exhibit 1008 (Mohania)
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`9.
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`Attached as Exhibit E is a true and correct copy of “Modulation of
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`expression of Programmed Death-1 by administration of probiotic Dahi in DMH-
`
`induced colorectal carcinogenesis in rats,” authored by Dheeraj Mohania, et al. and
`
`2
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`Genome Exhibit 1060
`Page 3 of 12
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`
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`published by Mattioli 1885 in Acta Bio Medica, Vol. 84, Issue 2, September 2013,
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`pp. 102-09 (“Mohania”). This document has been designated as Ex. 1008 in this
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`post grant review proceeding.
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`10. Attached as Exhibit F is a true and correct copy of a printout from
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`Mattioli 1885’s webpage
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`(http://www.mattioli1885journals.com/index.php/actabiomedica/article/view/2659)
`
`describing Mohania and stating that it was published on September 1, 2013.
`
`Exhibit 1010 (van der Waaij)
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`11. Attached as Exhibit G is a true and correct copy of “The Influence of
`
`antibiotics on gut colonization,” authored by D. van der Waaij, et al., and
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`published by Oxford University Press in the Journal of Antimicrobial
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`Chemotherapy, Vol. 18, Issue Supplement C, October 1986, pp. 155-58 (“van der
`
`Waaij”). This document has been designated as Ex. 1010 in this post grant review
`
`proceeding.
`
`12. Attached as Exhibit H is a true and correct copy of a printout from the
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`Oxford University Press’s webpage (https://academic.oup.com/jac/article-
`
`abstract/18/Supplement_C/155/698914?redirectedFrom=fulltext) describing van
`
`der Waaij and stating that it was published on October 1, 1986.
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`
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`3
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`Genome Exhibit 1060
`Page 4 of 12
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`
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`Exhibit 1016 (Sharon)
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`13. Attached as Exhibit I is a true and correct copy of “Immune
`
`checkpoints in cancer clinical trials,” authored by Elad Sharon, et al., and
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`published by the Cancer Communications (formerly known as Chinese Journal of
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`Cancer1), Vol. 33, Issue 9, September 2014, pp. 434-44 (“Sharon”). This
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`document has been designated as Ex. 1016 in this post grant review proceeding.
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`14. Attached as Exhibit K is a true and correct copy of a printout from the
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`Cancer Communications’ webpage (http://www.cjcsysu.com/TOC-
`
`en.asp?y=2014&m=9) describing Sharon and stating that it was published on
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`September 5, 2014.
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`Exhibit 1021 (Kandoth)
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`15. Attached as Exhibit L is a true and correct copy of “Mutational
`
`landscape and significance across 12 major cancer types,” authored by Cyriac
`
`Kandoth, et al., and published by Macmillan Publishers in Nature International
`
`Journal of Science, Vol. 502, October 2013, pp. 333-39 (“Kandoth”). This
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`document has been designated as Ex. 1021 in this post grant review proceeding.
`
`
`1 I understand that the Chinese Journal of Cancer changed its name to Cancer
`
`Communications on March 1, 2018. See Exhibit J (a true and correct copy of a
`
`printout from the Cancer Communications’ webpage (http://www.cjcsysu.com/)).
`
`4
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`Genome Exhibit 1060
`Page 5 of 12
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`
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`
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`16. Attached as Exhibit M is a true and correct copy of a printout from
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`Springer Nature’s2 webpage (https://www.nature.com/articles/nature12634)
`
`describing Kandoth and stating that it was published on October 17, 2013.
`
`Exhibit 1024 (Scott)
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`17. Attached as Exhibit O is a true and correct copy of “Monoclonal
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`antibodies in cancer therapy,” authored by Andrew M. Scott, et al. and published
`
`by the Cancer Research Institute in Cancer Immunity, Vol. 12, Issue 1, January
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`2012 (“Scott”). This document has been designated as Ex. 1024 in this post grant
`
`review proceeding.
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`18. Attached as Exhibit P is a true and correct copy of a printout from the
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`American Association for Cancer Research’s3 webpage
`
`
`2 I understand Springer Nature was created in 2015 as the result of a merger
`
`between Springer Science+Business Media and the majority of Macmillan Science
`
`and Education (including the Nature publishing Group). See Exhibit N attached
`
`herein, which is a true and correct printout of a webpage
`
`(https://www.springer.com/gp/about-springer/history) from the Springer Nature
`
`website.
`
`3 I understand that the American Association for Cancer Research maintains the
`
`entire archive of Cancer Immunity on its website as part of a collaboration between
`
`the Cancer Research Institute and the American Association for Cancer Research.
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`5
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`Genome Exhibit 1060
`Page 6 of 12
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`
`
`(http://cancerimmunolres.aacrjournals.org/content/canimmarch/12/1) stating that
`
`
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`Scott was published on January 1, 2012.
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`Exhibit 1026 (Pardoll)
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`19. Attached as Exhibit R is a true and correct copy of “The blockade of
`
`immune checkpoints in cancer immunotherapy,” authored by Drew M. Pardoll and
`
`published by Macmillan Publishers in Nature Reviews Cancer, Vol. 12, Issue 4,
`
`April 2012, pp. 252-64 (“Pardoll”). This document has been designated as Ex.
`
`1026 in this post grant review proceeding.
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`20. Attached as Exhibit S is a true and correct copy of a printout from the
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`Springer Nature’s4 webpage (https://www.nature.com/articles/nrc3239) describing
`
`Pardoll and stating that it was published on March 22, 2012.
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`Exhibit 1027 (DiMasi)
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`21. Attached as Exhibit T is a true and correct copy of “Economics of
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`New Oncology Drug Development,” authored by Joseph A. DiMasi, et al., and
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`published by the American Society of Clinical Oncology in the Journal of Clinical
`
`
`See Exhibit Q attached herein, which is a true and correct printout of a webpage
`
`(http://cancerimmunolres.aacrjournals.org/content/by/year/canimmarch;2012) from
`
`the American Association for Cancer Research.
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`4 See footnote 2.
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`6
`
`Genome Exhibit 1060
`Page 7 of 12
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`
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`Oncology, Vol. 25, No. 2, January 2007, pp. 209-16 (“DiMasi”). This document
`
`has been designated as Ex. 1027 in this post grant review proceeding.
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`22. Attached as Exhibit U is a true and correct copy of a printout from the
`
`American Society of Clinical Oncology’s webpage
`
`(https://ascopubs.org/doi/full/10.1200/JCO.2006.09.0803) describing DiMasi and
`
`stating that it was published on January 10, 2007.
`
`Exhibit 1028 (Thungappa)
`
`23. Attached as Exhibit V is a true and correct copy of “Immune
`
`checkpoint inhibitors in lung cancer: the holy grail has not yet been found . . .,”
`
`authored by Satheesh Thungappa, et al., and published by the European Society for
`
`Medical Oncology in ESMO Open in March 2017 (“Thungappa”). This document
`
`has been designated as Ex. 1028 in this post grant review proceeding.
`
`24. Attached as Exhibit W is a true and correct copy of a printout from the
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`European Society for Medical Oncology’s webpage
`
`(https://esmoopen.bmj.com/content/2/1/e000162.info) describing Thungappa and
`
`stating that it was published on March 27, 2017.
`
`
`
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`
`
`
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`
`7
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`Genome Exhibit 1060
`Page 8 of 12
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`
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`Exhibit 1032 (Kaiser)
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`25. Attached as Exhibit X is a true and correct copy of a printout of a
`
`webpage from Science Magazine’s website
`
`(https://www.sciencemag.org/news/2015/03/why-powerful-cancer-drug-only-
`
`helps-some-patients), which is an article entitled, “Why a powerful cancer drug
`
`only helps some patients,” authored by Jocelyn Kaiser and, as indicated in Exhibit
`
`X, was published on March 12, 2015 (“Kaiser”). This document has been
`
`designated as Ex. 1032 in this post grant review proceeding.
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`Exhibit 1034 (Ivanov)
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`26. Attached as Exhibit Y is a true and correct copy of “Intestinal
`
`commensal microbes as immune modulators,” authored by Ivaylo I. Ivanov, et al.,
`
`and published by Elsevier in Cell Host & Microbe, Vol. 12, Issue 4, October 2012,
`
`pp. 496-508 (“Ivanov”). This document has been designated as Ex. 1034 in this
`
`post grant review proceeding.
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`27. Attached as Exhibit Z is a true and correct copy of a printout from
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`Cell Host & Microbe’s webpage (https://www.cell.com/cell-host-
`
`microbe/fulltext/S1931-3128(12)00316-
`
`2?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2
`
`FS1931312812003162%3Fshowall%3Dtrue) describing Ivanov and stating that it
`
`was published on October 18, 2012.
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`8
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`Genome Exhibit 1060
`Page 9 of 12
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`
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`Exhibit 1035 (Hooper)
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`28. Attached as Exhibit AA is a true and correct copy of “Interactions
`
`between the microbiota and the immune system,” authored by Lora V. Hooper, et
`
`al., and published by the American Association for the Advancement of Science in
`
`Science Magazine, Vol. 336, Issue 6086, June 2012, pp. 1268-73 (“Hooper”). This
`
`document has been designated as Ex. 1035 in this post grant review proceeding.
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`29. Attached as Exhibit AB is a true and correct copy of a printout from
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`Science Magazine’s webpage
`
`(https://science.sciencemag.org/content/336/6086/1268.abstract) describing
`
`Hooper and stating that it was published on June 08, 2012.
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`Exhibit 1037 (Eckburg)
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`30. Attached as Exhibit AC is a true and correct copy of “Diversity of the
`
`human intestinal microbial flora,” authored by Paul B. Eckburg, et al., and
`
`published by the American Association for the Advancement of Science in Science
`
`Magazine, Vol. 308, Issue 5728, June 2005, pp. 1635-38 (“Eckburg”). This
`
`document has been designated as Ex. 1037 in this post grant review proceeding.
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`31. Attached as Exhibit AD is a true and correct copy of a printout from
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`Science Magazine’s webpage
`
`(https://science.sciencemag.org/content/308/5728/1635.abstract) describing
`
`Eckburg and stating that it was published on June 10, 2005.
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`9
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`Genome Exhibit 1060
`Page 10 of 12
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`
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`Exhibit 1038 (Lopez)
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`32. Attached as Exhibit AE is a true and correct copy of “Distinct
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`Bifidobacterium strains drive different immune responses in vitro,” authored by
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`Patricia López, et al., and published by ScienceDirect (operated by publisher
`
`Elsevier) in the International Journal of Food Microbiology, Vol. 138, Issue 1-2,
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`March 2010, pp. 157-65 (“López”). This document has been designated as Ex.
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`1038 in this post grant review proceeding.
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`33. Attached as Exhibit AF is a true and correct copy of a printout from
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`the ScientDirect’s webpage
`
`(https://www.sciencedirect.com/science/article/pii/S016816050900676X)
`
`describing López and stating that it was published on March 31, 2010.
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`Exhibit 1040 (Reddy)
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`34. Attached as Exhibit AG is a true and correct copy of “Inhibitory effect
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`of Bifidobacterium longum on Colon, Mammary, and Liver Carcinogenesis
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`Induced by 2-Amino-3-methylimidazo[4,5-f]quinolone, a Food Mutagen,”
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`authored by Bandaru S. Reddy, et al., and published by the American Association
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`for Cancer Research in Cancer Research, Vol. 53, Issue 17, September 1993, pp.
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`3914-918 (“Reddy”). This document has been designated as Ex. 1040 in this post
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`grant review proceeding.
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`10
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`Genome Exhibit 1060
`Page 11 of 12
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`35.
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`‘ Attached as Exhibit AH is a true and correct copy of a printout from
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`the American Association for Cancer Research’s webpage
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`(htm://cancerres.aacriournals.org/content/53/l7/3914.10ng) describing Reddy and
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`stating that it was published in September 1993.
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`I declare that all statements made herein on my own knowledge are true and that
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`all statements made on information and belief are believed to be true, and that
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`these statements were made with the knowledge that willful false statements and
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`the like so made are punishable by fine or imprisonment, or both, under Section
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`1001 or Title 18 of the United States Code.
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`Dated:
`
`()ENEZflglg’
`
`By: £2 (Mg {21 ééié
`
`Reeves Gillis
`
`l 1
`
`Genome Exhibit 1060
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`Page 12 of12
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`Genome Exhibit 1060
`Page 12 of 12
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`
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