Rimfrost AS et al. vs AKER BIOMARINE ANTARCTIC AS

PETITIONER'S FOURTH UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION REGARDING FEDERAL CIRCUIT APPEAL AND MANDATE

Patent Owner's Notice of Appeal

Final Written Decision

Hearing Transcript

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

Order - Trial Hearing

Petitioner's Oral Hearing Request

Patent Owner's Request for Oral Hearing

PETITIONER¿¿¿S FIRST UPDATED EXHIBIT LIST

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

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).

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

Reply Declaration of Dr. Stephen J. Tallon

Reply IPR2017-00745

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

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, Breivik III)

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

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 (Enzymotec).

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).

Chen, U.S. Patent App. 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, publication date January 24, 2008.

Mayzaud ¿¿¿Changes in lipid composition of the Antarctic krill Euphausia superba in the Indian sector of the Antarctic Ocean: influence of geographical location, sexual maturity stage and distribution among organs¿¿¿ , Vol. 173: 149-162 (1998)

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

Deposition Transcript of Dr. Nils Hoem

Neptune GRAS Agency Response Letter GRN 000242

Petitioner's NOD Dr Hoem IPR2017-00745

Patent Owner's Response

AKER BIOMARINE ANTARCTIC EXHIBIT LIST

Yamaguchi

Prescott

Fricke

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

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

Declaration of Dr. Nils Hoem

Zimmerman

Calder

Patent Owner's Notice of Deposition of Dr. Stephen J. Tallon

Notice of Stipulation to New Due Dates 1-2

Certificate of Service

Decision Institution of Inter Partes Review

Scheduling Order

Petitioner's Second Updated Mandatory Submission IPR2017-00745

Conduct of the Proceeding

Notice of Accord Filing Date

Petitioner's First Updated Mandatory Submission

Patent Owner Mandatory Notice

Aker Power of Attorney

U.S. Patent No. 9,078,905 B2

Power of Attorney

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

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

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)

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

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

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)

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

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

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

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)

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)

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).

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)

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)

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).

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

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

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

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

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

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).

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

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)

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

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

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

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

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

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

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).

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

Declaration of Dr Steven Tallon

PETITION