RIMFROST AS et al. vs AKER BIOMARINE ANTARCTIC AS

EXPUNGED

Decision - Denying Patent Owner's Request on Rehearing of Final Written Decision

Exhibit 3001

PATENT OWNER¿¿¿S SUPPLEMENTAL RESPONSE BRIEF ADDRESSING IMPACT OF HUNTING TITAN

PETITIONER'S SUPPLEMENTAL BRIEF ADDRESSING POTENTIAL IMPACT OF HUNTING TITAN

PATENT OWNER¿¿¿S REPLY TO PETITIONER¿¿¿S RESPONSE TO SUPPLEMENTAL BRIEF

PETITIONER'S RESPONSE TO PATENT OWNER'S SUPPLEMENTAL BRIEF

PATENT OWNER¿¿¿S SUPPLEMENTAL BRIEF

PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5

ORDER - Conduct of the Proceeding Relating to Request on Rehearing of Final Written Decision 37 C.F.R. 42.71(d)

PETITIONER'S THIRD UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

PATENT OWNER¿¿¿S REPLY TO PETITIONER¿¿¿S RESPONSE ON REQUEST FOR REHEARING

PETITIONER'S RESPONSE TO PATENT OWNER¿¿¿S REQUEST FOR REHEARING

PATENT OWNER REQUEST FOR REHEARING PURSUANT TO 37 C.F.R. ¿¿ 42.71(d)

Final Written Decision

Hearing Transcript

PETITIONER'S SECOND UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

Transcript of call conducted February 6, 2019

ORDER Conduct of the Proceeding 37 C.F.R. ¿¿ 42.5

PETITIONER'S SUR-REPLY TO PATENT OWNER'S MOTION TO AMEND THE CLAIMS

ORDER Oral Hearing

Patent Owner Sur-Reply

Patent Owner Request for Oral Hearing

PETITIONER'S REQUEST FOR ORAL ARGUMENT

Conduct of the Proceeding and Amended Schedule 37 C.F.R. sec. 42.5

Patent Owner's Updated Exhibit List

Transcript of Telephone Conference, August 30, 2018

PATENT OWNER¿¿¿S UPDATED EXHIBIT LIST

Patent Owner¿¿¿s Reply to Petitioner¿¿¿s Opposition to Motion to Amend the Claims

Deposition Transcript of Stephen Tallon

PATENT OWNER¿¿¿S NOTICE OF DEPOSITION OF DR. STEPHEN J. TALLON

Declaration of Rakesh Kapoor.

FDA GRAS Notices, August 05, 2007, listing GRN 226 on Internet, ¿¿¿Krill-derived lecithin,¿¿¿ Wayback Machine, https://web.archive.org/web/20070805011458/http://www.cfsan.fda.gov:80/~rdb/opa-gras.html.

Affidavit of Christopher Butler, Office Manager of Internet Archive dated August 22, 2017 regarding FDA GRAS Notices and Enzymotec related webpages

FDA, Freedom of Information Annual Report 2007, https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/ucm148025.htm.

Deposition Transcript of Dr. Nils Hoem (IPR2017-00745, inter alia)

Neptune GRAS Agency Response Letter GRN 000242.

Marathe, et al., Inflammatory Platelet-activating Factor-like Phospholipids in Oxidized Low Density Lipoproteins Are Fragmented Alkyl Phosphatidylcholines, J Biol Chem. 1999 Oct 1;274(40):28395-28404.

Stremler, et al., Human Plasma Platelet-activating Factor Acetylhydrolase - Oxidatively Fragmented Phospholipids As Substrates, (1991) J. Biol. Chem. 266, 11095¿¿¿11103.

Aker GRAS Agency Response Letter GRN 000371.

PETITIONER¿¿¿S FIRST UPDATED EXHIBIT LIST

Declaration of Robert S. McQuate.

Gaynor, P, ¿¿¿How U.S. FDA's GRAS Notification Program Works¿¿¿, Reprinted with permission of the publishers from Food Safety Magazine December 2005/January 2006. http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm083022.htm

Federal Register, Vol. 62, No. 74, pp. 18938-18964, April 17, 1997

Enzymotec website pages (September 25, 2007) (https://web.archive.org/web/20070925024350/http://www.enzymotec.com/PageIndex.asp?cc=01020403) (https://web.archive.org/web/20070925024521/http://www.enzymotec.com/Page.asp?cc=01020408

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).

Hoem, N., ¿¿¿Composition of Antarctic krill oil and methods for its harvesting, production and qualitative and quantitative analysis¿¿¿, Aker BioMarine, Newcastle Australia November 2013 (Hoem).

Reply and Opposition Declaration of Dr. Stephen J. Tallon (IPR2018-00295)

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

Affidavit of Christopher Butler, Office Manager of Internet Archive, dated February 5, 2018, regarding Rimfrost Exhibit 1077, Pure Encapsulations online literature for its Krill-plex NKO¿¿¿ product, webpage from August 19, 2004.

Final Written Decision, IPR2017-00745, August 10, 2018, Paper 24 (U.S. Patent No. 9,078,905).

Final Written Decision, IPR2017-00746, August 10, 2018, Paper 23 (U.S. Patent No. 9,028,877).

Winther, Hoem, et al., Elucidation of phosphatidylcholine composition in krill oil extracted from Euphausia superba, Lipids. 2011 Jan;46(1):25-36. doi: 10.1007/s11745-010-3472-6. Epub 2010 Sep 17.

Deposition Transcript of Dr. Nils Hoem (IPR2018-00295)

Petitioner's Reply

Petitioner's Opposition to PO's Motion to Amend

Petitioner's Notice of Deposition of Dr Nils Hoem

Patent Owner's Response

Patent Owner's Exhibit List

Declaration of Dr. Nils Hoem in Support of Patent Owner¿¿¿s Response

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Marathe et al., Inflammatory Platelet-activating Factor-like Phospholipids in Oxidized Low Density Lipoproteins Are Fragmented Alkyl Phosphatidylcholines. J. Biol. Chem. (1999) 274(40):28395-28404

U.S. Appl. 14/020,155 as filed

Transcript of Deposition of Dr. Stephen Tallon

Patent Owner's Motion to Amend the Claims

Fricke, H. et al. ¿¿¿1-O-Alkylglycerolipids in Antarctic Krill (Euphausia Superba DANA)¿¿¿, Comp. Biochem. Physiol. Vol. 85B, No. 1, pp. 131-134, 1986

Reply Declaration of Dr. Stephen J. Tallon, IPR2017-00745, U.S. Patent No. 9,078,905, dated January 24, 2018

Declaration of Dr. Nils Hoem in Support of Patent Owner¿¿¿s Motion to Amend

Petition for Post Grant Review, U.S. Patent No. 9,644,170, Case No. PGR2018-00033

WO 2007/136281

Patent Abstract JP 04-057853 published February 25, 1992

US 2004/0241249

US 2006/0193962

Order - Conduct of the Proceeding

Petitioner¿¿¿s First Updated Submission of Mandatory Notice Information

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

Certificate of Service

Trial Instituted Document

EXPUNGED

SCHEDULING ORDER

Notice of Accord Filing Date

Power of Attorney

Patent Owner Mandatory Notice

Certificate of Service

Budzi¿¿ski, 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)

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

Power of Attorney 765 Patent

U.S. Patent No. 9,320,765 B2, filed September 6, 2013 (¿¿¿765 Patent)

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)

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)

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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 Antarctic Krill (Euphausia superba Dana),¿¿¿ LIPIDS 19(11):821-827 (1984) (Fricke)

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)

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 [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)

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

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 5B - Pages 2026-2250 - File History to U.S. Patent No. 9,034,388 B2, Serial No, 12/057,775 (¿¿¿388 File History)

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)

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)

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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)

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)

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 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 5A - Pages 1801-2025 - 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)

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)

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

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1053 Part 2 - Pages 501-998 - File History to U.S. Patent No. 9,320,765 B2, Serial No, 14/020,155 (¿¿¿765 File History)

Antarctica Select Krill Oil Online Literature and Purchase Order Form and linked FDA webpage from 2006

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Grynbaum, M., et al. ¿¿¿Unambiguous detection of astaxanthin and astaxanthin fatty acid esters in krill (Euphausia superba Dana),¿¿¿ J. Sep. Sci., 28, 1685¿¿¿1693 (2005)

U.S. Patent No. 9,034,388 B2, filed May 28, 2008 (¿¿¿388 Patent)

Enzymotec, GRAS Notice No. GRN 000226 for ¿¿¿Krill-based Lecithin in Food,¿¿¿ and ¿¿¿Krill-derived lecithin, dated May 26, 2007 and filed by the FDA May 31, 2007 (Enzymotec)

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

1053 Part 1 - Pages 1-500 - File History to U.S. Patent No. 9,320,765 B2, Serial No, 14/020,155 (¿¿¿765 File History)

Notice of Commission Determination ending Investigation 337-TA-1019, dated May 23, 2017

Respondents¿¿¿ Motion for Leave to Amend Their Response to the Complaint and Notice of Investigation, United States International Trade Commission, Investigation No. 337-TA-1019 (ITC Amended Complaint),dated March 14, 2017

IDS filed March 17 2017 in file history for US Patent No. 9644169, Serial No. 15180431

IDS filed March 17 2017 in file history for US Patent No. 9644170, Serial No. 15180439

Markman Order (Public Version), Order 13, U.S. International Trade Commission, In the Matter of Certain Krill Oil Products and Krill Meal for Production of Krill Oil Products, Inv. No. 337-TA-1019, dated April 13, 2017

Krill Bill Bottle and Capsules from IRL

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).

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Affidavit of Christopher Butler, Office Manager of Internet Archive, dated November 8, 2017 regarding Krill Bill, Aquasource and FDA related webpages from 2006.

Pure Encapsulations online literature for its Krill-plex NKO¿¿¿ product, webpage from August 19, 2004. https://web.archive.org/web/20040819183137/www.purecaps.com/itemdy00.asp?T1=KP1

Del. District Court Stay of 16-cv-00035, pending resolution of IPRs, Order dated September 6, 2017.

1024 Part 8 - Pages 3084-3223 - File History to U.S. Patent No. 9,034,388 B2, Serial No, 12/057,775 (¿¿¿388 File History)

Declaration of Stephen Tallon for IPR2018-00295

Petition