Rimfrost AS et al. vs Aker BioMarine Antarctic AS

PETITIONER'S FIFTH UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

Final Written Decision Determining All Challenged Claims Unpatentable Denying Patent Owner’s Motion to Amend 35 U.S.C. sec 318(a)

Hearing Transcript

PETITIONER'S FOURTH UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

Order - Oral Hearing - 37 C.F.R. 42.70

Deposition of Dr. Hoem, September 12, 2019 (IPR2018-01178 and IPR2018-01179).

PETITIONER'S THIRD UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

USP42-NF37, "Krill Oil"

Standard for Fish Oils [including krill oil], CODEX STAN 329-2017, Codex Alimentarius Commission, Food and Agriculture Organization of the United Nations, World Health Organization,

PETITIONER'S SECOND UPDATED EXHIBIT LIST

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

PATENT OWNER'S REQUEST FOR ORAL ARGUMENT

PETITIONER'S REQUEST FOR ORAL ARGUMENT

PETITIONER'S NOTICE OF DEPOSITION OF DR. NILS HOEM

NOTICE OF STIPULATION OF NEW DUE DATES 4 AND 5

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

PATENT OWNER'S REPLY TO PETITIONER'S OPPOSITION TO MOTION TO AMEND CLAIMS

Patent Owner¿¿¿s Sur-Reply to Petitioner¿¿¿s Reply

PATENT OWNER'S UPDATED EXHIBIT LIST

Transcript of Deposition of Dr. Stephen Tallon, August 7, 2019

U.S. Appl. 14/020,162 as filed Corrected Page Numbers

NOTICE OF DEPOSITION OF DR. STEPHEN J. TALLON

Petitioner's Second Updated Mandatory Submission IPR 2018-01178

PETITIONER'S FIRST UPDATED EXHIBIT LIST

Declaration of Robert S. McQuate.

Declaration of Rakesh Kapoor.

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

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.

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)

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).

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

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

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

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

Neptune GRAS Agency Response Letter GRN 000242.

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

Declaration by Nils Hoem in Support of Request for Inter Partes Reexamaination of U.S. Patent No. 8,057,825, Control No. 95/001,819, executed September 16, 2011.

Japanese Laid Open Publication S63-23819 (Murata).

Itano Refrigerated Food Co., Ltd., Bio & High Technology Announcement and Natural Astaxanthin & Krill Lecithin, pp. 1-16, Exhibit 1124 (¿¿¿Itano¿¿¿).

Paper 11 (IPR2018-01178), PO¿¿¿s Contingent Motion to Amend, used at Deposition of Dr. Nils Hoem held on July 2, 2019.

Patent Owner¿¿¿s Motion to Amend, Paper 16, IPR2018-00295 (U.S. Patent No. 9,320,765).

Patent Owner¿¿¿s Reply to Petitioner's Opposition to MTA, Paper 22, IPR2018-00295 (U.S. Patent No. 9,320,765).

Patent Owner¿¿¿s Sur-Reply to Petitioner's Reply, Paper 27, IPR2018-00295 (U.S. Patent No. 9,320,765).

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.

Aker GRAS Agency Response Letter GRN 000371.

"Rimfrost succeeds in having two Aker krill patents thrown out; Aker vows war will continue", 24-Aug-2018, (https://www.nutraingredients-usa.com/Article/2018/08/24/Rimfrost-succeeds-in-having-two-Aker-krill-patents-thrown-out-Aker-vows-war-will-continue).

U.S. Patent No. 8,057,825 C1, ¿¿¿Krill Extracts for Treatment of Cardiovascular Diseases¿¿¿, Inter Partes Reexamination Certificate (all claims cancelled).

Deposition Transcript of Dr. Nils Hoem held on July 2, 2019 (IPR2018-01178 & IPR2018-01179.)

Final Written Decision, IPR2018-00295, June 12, 2019, Paper 35 (U.S. Patent No. 9,320,765).

Patent Owner¿¿¿s Response, Paper 14, IPR2018-00295 (U.S. Patent No. 9,320,765).

Reply and Opposition Declaration of Dr Stephen J. Tallon (IPR2018-01178 & IPR2018-01179)

PETITIONER'S REPLY TO PATENT OWNER'S RESPONSE PURSUANT TO 37 C.F.R. ¿¿ 42.23 (b)

PETITIONER'S OPPOSITION TO PATENT OWNER'S MOTION TO AMEND THE CLAIMS

Corrected Caption Tallon Deposition April 2019

Certificate of Service

PETITIONER¿¿¿S NOTICE OF DEPOSITION OF DR. NILS HOEM

Patent Owner's Response

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

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

Patent Abstract JP 04-057853 published February 25, 1992

Transcript of Deposition of Dr. Stephen Tallon, April 2, 2019

Petitioner¿¿¿s Demonstrative Exhibit from IPR2018-00295

Patent Owner's Motion to Amend the Claims

Yamaguchi, K. et al. ¿¿¿Supercritical Carbon Dioxide Extraction of Oils from Antarctic Krill¿¿¿, J. Agric. Food Chem. 1986, 34, 904-907

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Calder, P. ¿¿¿n-3 Polyunsaturated fatty acids, inflammation, and inflammatory diseases1-3¿¿¿, Am. J. Clin. Nutr. 2006; 83(suppl): 1505S-19S

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

Zierenberg et al., Intestinal absorption of polyenephosphatidylcholine in man, J. Lipid. Res. (1982) 23:1136-1142

Blank et al., Meats and fish consumed in the American diet contain substantial amounts of ether-linked phospholipids. J Nutr. (1992) 122(8):1656-61

Hartvigsen et al., 1-O-Alkyl-2-(w-oxo)acyl-sn-glycerols from Shark Oil and Human Milk Fat Are Potential Precursors of PAF Mimics and GHB. Lipids (2006) 41, 679¿¿¿693

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. 14/020,162 as filed

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

JP4057853 (Tisueno et al.)

US Patent No. 4814111 (Kearns et al.)

US Publication No. 20060078625 (Rockway)

US Patent No. 8057825 (Sampalis III)

WO 2007/136281

Transcript of Deposition of Dr. Stephen Tallon, December 12, 2018

Transcript of Deposition of Dr. Stephen Tallon, August 29, 2018

AKER BIOMARINE ANTARCTIC AS EXHIBIT LIST

Order Conduct of Proceeding MTA

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

Decision Institution of Inter Partes Review

Scheduling Order

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

Notice of Accord Filing Date

Power of Attorney

Mandatory Notice

Power of Attorney

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. Patent No. 9,375,453 B2, filed September 6, 2013 (¿¿¿453).

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

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

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).

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).

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).

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).

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).

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).

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

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

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).

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

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 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 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)

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)

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

Bruheim, U.S. Patent Application Publication No. US2008/0274203 A1, published November 6, 2008 (this is the publication of patent application serial no. 12/057,775 which issued as U.S. Patent No. of 9,034,388).

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

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

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

1055 Part 1 - Pages 1-400 File History to U.S. Patent No. 9,375,453 B2, Serial No, 14/020,162 (¿¿¿453 File History)

1055 Part 2 - Pages 401-800 File History to U.S. Patent No. 9,375,453 B2, Serial No, 14/020,162 (¿¿¿453 File History)

1055 Part 3 - Pages 801-1109 File History to U.S. Patent No. 9,375,453 B2, Serial No, 14/020,162 (¿¿¿453 File History)

1063 Part 1 - Pages 1-400 File History to U.S. Patent No. 9,644,170 B2, Serial No, 15/180,439 (¿¿¿170 File History)

1063 Part 2 - Pages 401-800 File History to U.S. Patent No. 9,644,170 B2, Serial No, 15/180,439 (¿¿¿170 File History)

1063 Part 3 ¿¿¿ Pages 801-1107 File History to U.S. Patent No. 9,644,170 B2, Serial No, 15/180,439 (¿¿¿170 File History)

Krill Bill Bottle and Capsules from IRL.

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

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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).

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).

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 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).

U.S. Patent No. 9,644,170 B2, filed June 13, 2016 (¿¿¿170)

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

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¿¿¿

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).

Affidavit of Christopher Butler, Office Manager of Internet Archive, dated November 8, 2017, for Rimfrost Exhibits 1070 and 1071, regarding Krill Bill, Aquasource and FDA related webpages from 2006.

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

Mayzaud et al, ¿¿¿Changes in lipid composition of the Antarctic krill Euphausia superba in the Indian sector of the Antarctic Ocean: . . . ¿¿¿ Mar.Ecol.Prog. Vol. 173: 149-162 (1998) (Mayzaud).

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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 Oct 1;274(40):28395-28404.

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Mimoun-Benarroch, et al., The Bioavailability of Astaxanthin is Dependent on both the Source and the Isomeric Variants of the molecule, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca: , 2016, pp. 61-69(9).

Higuera-Ciapara, et al., Astaxanthin: A Review of its Chemistry and Applications, Crit Rev Food Sci Nutr. 2006;46(2):185-96

Declaration of Dr Stephen J. Tallon

Petition