Rimfrost AS et al. vs AKER BIOMARINE ANTARCTIC AS

Final Written Decision

Hearing Transcript

PETITIONER¿¿¿S SECOND UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

Order - Trial Hearing

Petitioner's Oral Hearing Request

Patent Owner's Oral Hearing Request

Reply

PETITIONER¿¿¿S FIRST UPDATED EXHIBIT LIST

Exhibit 1048 - Enzymotec, GRAS Notice No. GRN 000226 for ¿¿¿Krill-based Lecithin in Food¿¿¿ and ¿¿¿Krill-derived lecithin¿¿¿ https://www.fda.gov/downloads/Food/Ingredients PackagingLabeling/GRAS/NoticeInventory/ucm263930.pdf, dated May 26, 2007

Krill Bill Online Purchase Order and Specification Pages from 2006 (https://web.archive.org/web/20060715103715/http://www.krillbill.com:80/purchase.htm; https://web.archive.org/web/20060715103809/http://www.krillbill.com/profile.htm).

Burri, L., et al., ¿¿¿Fingerprinting Krill Oil by 31P, 1H and 13C NMR Spectroscopies¿¿¿, J Am Oil Chem Soc (2016) 93:1037-1049 (Burri).

FDA, Agency Response Letter GRAS Notice No. GRN 000226, https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm153881.htm, January 3, 2008.

Chen, U.S. Patent Application Publication No. US 2008/0021000 A1, for ¿¿¿Mixtures of and Methods of Use for Polyunsaturated Fatty Acid-Containing Phospholipids and Alkyl Ether Phospholipids Species¿¿¿, filing date July 19, 2006

Neptune, GRAS Notice [No. GRN 000242] for ¿¿¿High Phospholipid Krill Oil¿¿¿ https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm269133.pdf, dated January 18, 2008 and filed by the FDA February 4, 2008 (Neptune GRAS).

Notices of Hoem Depositions

Hoem Deposition Exhibit 4, Declaration of Finn Myhren, In the Matter of Australian Patent Application No. 2013227998, dated October 20, 2017

Aker GRAS [No. GRN 000371], ¿¿¿Notification of GRAS Determination of Krill Oil¿¿¿, December 14, 2010. https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&id=371

Neptune GRAS Agency Response Letter GRN 000242

Exhibit 1084 - Mayzaud

Reply Declaration of Dr. Stephen J. Tallon

Deposition Transcript of Dr. Nils Hoem

Petitioner's NOD Dr Hoem IPR2017-00748

Declaration of Dr. Nils Hoem

Prescott

Patent Owner's Response

AKER BIOMARINE ANTARCTIC AS EXHIBIT LIST

Yamaguchi

Zimmerman

Calder

Fricke

Deposition of Dr. Stephen J. Tallon, Vol. 1

Deposition of Dr. Stephen J. Tallon, Vol. 2

Notice of Stipulation to New Due Dates 1-2

Certificate of Service

Notice of Deposition of Dr. Stephen J. Tallon

Trial Instituted Document

Scheduling Order

Petitioner's First Updated Mandatory Submission IPR2017-00748

Conduct of the Proceeding

Notice of Accord Filing Date

Mandatory Notice

Power of Attorney

1002 U.S. Provisional Patent Application No. 61/024,072, filed January 28, 2008 ('072 Provisional)

1005 U.S. Provisional Patent Application No. 60/920,483, filed March 28, 2007 ('483 Provisional)

Power of Attorney

1001 U.S. Patent No. 9,028,877 ('877 Patent)

1003 U.S. Provisional Patent Application No. 60/983,446, filed October 29, 2007 ('446 Provisional)

1004 U.S. Provisional Patent Application No. 60/975,058, filed September 25, 2007 ('058 Provisional)

1007 Bottino, N.R.,"The Fatty Acids of Antarctic Phytoplankton and Euphausiids. Fatty Acid Exchange among Trophic Levels of the Ross Sea", Marine Biology, 27, 197-204 (1974) (Bottino)

1008 Budzinski, E., P. Bykowski and D. Dutkiewicz, 1985, Possibilities of processing and marketing of products made from Antarctic krill. FAO Fish.Tech. Pap., (268):46 (Budzinski)

1010 Fricke et al., "Lipid, Sterol and Fatty Acid Composition of Antactic Krill (Euphausia superba Dana)," LIPIDS 19(11):821-827 (1984) (Fricke)

1012 Sampalis [I] et al., "Evaluation of the Effects of Neptune Krill Oil on the Management of Premenstrual Syndrome and Dysmenorrhea" Altern. Med. Rev. 8(2):171-179 (2003)(Sampalis I)

1013 Sampalis [II] et al.,WO 2003/011873, published February 13, 2003, "Natural Marine Source Phospholipids Comprising Flavonoids, Polyunsaturated Fatty Acids and Their Applications" (Sampalis II)

1014 Tanaka [I] et al., "Platelet Activating Factor (PAF) Like Phospholipids Formed During Peroxidation of Phosphatidylcholines from Different Foodstuffs", Biosci.Biotech. Biochem., 59(8) 1389-1393 (1995) (Tanaka I).

1016 Beaudoin et al., "Method of Extracting Lipids From Marine and Aquatic Animal Tissues" United States Patent No. 6,800,299 B1 filed July 25, 2001 (Beaudoin).

1019 Porzio et al., "Encapsulation Compositions and Processes for Preparing the Same", U.S. Patent No. 7,488,503 B1 filed March 31, 2004 ("Porzio").

1021 Complaint filed in Aker Biomarine Antarctic AS v. Olympic Holding AS, et al., Case No. 1:16-cv-00035

1023 Federal Register Notice of Institution of Investigation 337-TA-1019 on September 16, 2016 by the ITC (81 Fed. Reg. pages 63805-63806)

1024 Part 4 - Pages 1351-1800 - File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1024 Part 5 - Pages 1801-2250 - File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1024 Part 7 - Pages 2701-3083 - File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1009 Catchpole, WO 2007/123424, published November 1, 2007, "Process for Separating Lipid Materials," (Catchpole)

1011 Randolph, et al., U.S. Patent Application Publication No. US/2005/0058728 A1, "Cytokine Modulators and Related Method of Use"(Randolph)

1015 Tanaka (II) et al., "Extraction of Phospholipids from Salmon Roe with Supercritical Carbon Dioxide and an Entrainer", Journal of Oleo Science Vol. 53 (2004) No. 9, p.17-424 (Tanaka II)

1017 Folch et al., "A simple method for the isolation and purification of total lipides from animal tissues", J. Biol. Chem. (1957) 226:497-509 (Folch).

1018 Kochian et al, "Agricultural Approaches to Improving Phytonutrient Content in Plants: An Overview", Nutrition Reviews, Vol. 57, No. 9, September 1999: S13-S18.

1020 Bunea, et al., "Evaluation Of The Effects Of Neptune Krill Oil On The Clinical Course Of Hyperlipidemia", Altern Med Rev. 2004; 9:420 428 (Bunea).

1022 Affidavits of Service Filed in Aker Biomarine Antarctic AS v.Olympic Holding AS, et al., Case No. 1:16-cv-00035

1024 Part 1 - Pages 1-450 - File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1024 Part 2 - Pages 451-900 - File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1024 Part 3 - Pages 901-1350 - File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1024 Part 6 - Pages 2251-2700 -File History to U.S. Patent No. 9,034,388 B2, Serial No. 12/057,775 ('388 File History)

1026 Part 2 - Pages 451-882 - File History to U.S. Patent No. 9,078,905 B2, Serial No. 14/490,221 ('905 File History)

1025 Part 1 - Pages 1-375 - File History to U.S. Patent No. 9,028,877 B2, Serial No. 14/490,176 ('877 File History)

1025 Part 2 - Pages 376-724 - File History to U.S. Patent No. 9,028,877 B2, Serial No. 14/490,176 ('877 File History)

1026 Part 1 - Pages 1-450 - File History to U.S. Patent No. 9,078,905 B2, Serial No. 14/490,221 ('905 File History)

1028 Hawley's Condensed Chemical Dictionary, p. 893, 13th ed.,1997 (Hawley's)

1029 Webster's New Universal Unabridged Dictionary, 2nd ed., p.732, 1983 (Webster's)

1031 Halliday, Jess, "Neptune-Degussa Deal to Develop Phospholipids, Adapt Krill Oil," http://www.nutraingredients-usa.com/Suppliers2/Neptune-Degussa-deal-to-develop-phospholipids-adapt-krill-oil, December 12, 2005 (Neptune-DeGussa).

1032 Grantham, G.J., "The Utilization Of Krill", UNDP/FAO Southern Ocean Fisheries Survey Programme (1977) (Grantham).

1033 Yoshitomi, U.S. Patent Application Publication No.US/2003/0113432 A1, "Process For Making Dried Powdery and Granular Krill" (Yoshitomi).

1034 Kolakowska, A., ¿¿¿The influence of sex and maturity stage of krill (Euphausia superba Dana) upon the content and composition of its lipids¿¿¿, 1991, Pol. Polar Res. 12: 73-78 (Kolakowska).

1037 Breivik, WO 2008/060163 A1, ¿¿¿Process for Production of Omega-3 Rich Marine Phospholipids from Krill,¿¿¿ International filing date November 15, 2007 (Breivik PCT).

1027 Saether et al., "Lipolysis post mortem in North Atlantic krill". Comp. Biochem. Physiol. Vol. 83B, No. 1, pp. 51-55, 1986 (Saether).

1030 Tehoharides, U.S. Patent Application Publication No. US/2006/0013905 A1, "Anti-Inflammatory Compositions For Treating Multiple Sclerosis" (Tehoharides)

1035 Breivik, U.S. Patent Application Publication No. US 2010/0143571 A1, ¿¿¿Process for Production of Omega-3 Rich Marine Phospholipids from Krill¿¿¿ (Breivik).

1036 Breivik, U.S. Provisional Patent Application No. 60/859,289, ¿¿¿Processes for production of omega-3 rich marine phospholipids from krill¿¿¿, filed November 16, 2006 (Breivik ¿¿¿289 Provisional)

Declaration of Dr Stephen J. Tallon

Petition