Rimfrost AS et al. vs AKER BIOMARINE ANTARCTIC AS

Order: Decision Denying Request for Director Review

Ex. 3100 Director Review Request

PATENT OWNER'S REQUEST FOR DIRECTOR REVIEW

JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. 318(a)

Other: Hearing transcript

Petitioner's Demonstratives IPR2020-01532 and IPR2020-01533

PETITIONER'S THIRD UPDATED EXHIBIT LIST

Patent Owner's Updated Exhibit List

Patent Owner's Demonstratives IPR2020-01532 and IPR2020-01533

PETITIONER'S REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE EVIDENCE

PETITIONER'S SECOND UPDATED EXHIBIT LIST

PETITIONER'S OBJECTIONS PURSUANT TO 37 C.F.R. Section 42.64(b)(1)

PATENT OWNER'S OPPOSITION TO PETITIONER'S MOTION TO EXCLUDE

PATENT OWNER'S UPDATED EXHIBIT LIST

Declaration of Keimi Kanno

Declaration of ��ge Oterhals

Declaration of Elizabeth Delfino

Declaration of John Mitchell Jones

Patent Owner���s Certificate of Service for Supplementary Evidence dated July 22, 2021

PETITIONER'S MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. �� 42.64 (c)

ORDER Setting Oral Argument 37 C.F.R. sec 42.70

Patent Owner's Request for Oral Argument

PETITIONER'S REQUEST FOR ORAL ARGUMENT

PETITIONER'S RESPONSE TO PATENT OWNER'S SUBMISSION ADDRESSING PURPORTED IMPROPER EVIDENCE AND ARGUMENT IN PETITIONER���S REPLY TO PATENT OWNER���S RESPONSE

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

Patent Owner's Submission In Lieu of Denial Motion to Strike

AKER BIOMARINE ANTARCTIC AS UPDATED EXHIBIT LIST

Transcript of Deposition of Stephen J. Tallon, October 27, 2021

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

PETITIONER'S REPLY TO PATENT OWNER���S RESPONSE PURSUANT TO 37 C.F.R. �� 42.24(c)

PETITIONER'S FIRST UPDATED EXHIBIT LIST

Exhibit 1086 Dr. Tallon Reply Declaration 169 patent IPR2020 01532

Exhibit 1160 Fricke II 1986

Exhibit 1170 Jaczynski Deposition Transcript 9.13.2021

PETITIONER'S NOTICE OF CANCELLATION OF DEPOSITION OF DR. SNORRE TILSETH

PETITIONER'S NOTICE OF DEPOSITION OF DR. JACEK JACZYNSKI

PETITIONER'S NOTICE OF DEPOSITION OF DR. SNORRE TILSETH

PETITIONER���S OBJECTIONS PURSUANT TO 37 C.F.R. �� 42.64(b)(1)

PATENT OWNER'S RESPONSE TO PETITION FOR INTER PARTES REVIEW

PATENT OWNER'S EXIHIBIT LIST

Declaration of Dr. Snorre Tilseth

Pin et al. (2005)

Report K-300 F/T ATLANTIC NAVIGATOR 2004 -2005

Metadata for Ex. 2003

Meeting Notes dated May 5, 2006

Certified translation of Ex. 2005

Metadata for Ex. 2005

Draft Agreement

Metadata for Ex. 2008

Meeting Notes dated June 26, 2006

Certified translation of Ex. 2010

Metadata for Ex. 2010

Report K-313 Extraction of krill meal with ethanol

Metadata for Ex. 2013

Declaration of Dr. Jacek Jaczynski in Support of Patent Owner���s Response

Meal Definition from Cambridge English Dictionary

Yamaguchi et al. (1986)

Tanaka et al. (2003)

Transcript of Deposition of Stephen J. Tallon, June 17, 2021

Notice of Deposition

Trial Instituted Document

Scheduling Order

Notice of Accord Filing Date

Patent Owner Power of Attorney

Patent Owner Mandatory Notice

U.S. Patent No. 9,644,169

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

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

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

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

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)

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

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 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

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).

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

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

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

1024 Part 5B - Pages 2026-2250 File History to U.S. Patent No. 9,034,388 B2, Serial No, 12/057,775

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

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

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)

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

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).

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)

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

1024 Part 5A - Pages 1801-2025 File History to U.S. Patent No. 9,034,388 B2, Serial No, 12/057,775

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

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

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

Declaration of Robert S. McQuate

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

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

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

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

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 Provisional, Breivik III).

Bottino, N.R., "Lipid Composition of Two Species of Antarctic Krill: Euphausia Superba and E. Crystallorophias", Comp. Biochem. Physiol., 1975, Vol. 50B, pp. 479 to 484 (Bottino II).

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).

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. 9,034,388).

Declaration of Rakesh Kapoor

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

FDA, Agency Response Letter GRAS Notice No. GRN 000226, https://wayback.archive-it.org/7993/20171031031702/https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm153881.htm.

Enzymotec, GRAS Notice No. GRN 000226 for "Krill-based Lecithin in Food" and "Krill-derived lecithin" http://wayback.archive-it.org/7993/20171031055610/https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/UCM263930.pdf

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.

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

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

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

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

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

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

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)

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, see also https://wayback.archive-it.org/7993/20170404042219/https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnualReports/ucm148025.htm.

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

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

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

U.S. Patent No. 9,028,877

Krill Bill Bottle and Capsules from IRL

U.S. Patent No. 9,375,453

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://wayback.archive-it.org/7993/20170607013925/https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/UCM269133.pdf.

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.

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. See Exhibit 1092.

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).

Aker GRAS [No. GRN 000371], ¿¿¿Notification of GRAS Determination of Krill Oil¿¿¿, December 14, 2010. https://wayback.archive-it.org/7993/20170607010227/https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/UCM274421.pdf.

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). See Exhibit 1076.

Antarctica Select Krill Oil Online Literature and Purchase Order Form and linked FDA webpage from 2006 . . . . . https://web.archive.org/web/20060513152744/http://vm.cfsan.fda.gov/~dms/ds-oview.html). See Exhibit 1076 for more info re urls.

Mayzaud et al, "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" (1998)

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

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U.S. Patent No. 9,644,170

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Foss, et al., Natural occurrence of enantiomeric and Meso astaxanthin 7¿¿¿-crustaceans including zooplankton, Comparative Biochemistry and Physiology Part B: Comparative Biochemistry, Volume 86, Issue 2, 1987, Pages 313-314.

U.S. Patent No. 9,816,046

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

U.S. Patent No. 9,320,765

U.S. Patent No. 9,072,752

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

Inter Partes Review Certificate US 9,028,877 Kl cancelling all claims of U.S. Patent No. 9,028,877, issued March 12, 2020.

Inter Partes Review Certificate US 9,078,905 Kl cancelling all claims of U.S. Patent No. 9,078,905, issued March 11, 2020.

Final Written Decision Determining All Challenged Claims [claims 33¿¿¿61] Unpatentable and Denying Patent Owner¿¿¿s Motion to Amend, IPR2018-01179, Patent 9,375,453 B2, dated January 13, 2020.

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

File History for U.S. Patent No. 9,644,169, serial no. 15/180,431.

File History for U.S. Patent No. 9,816,046, serial no. 15/589,572

U.S. Patent No. 10,010,567

File History for U.S. Patent No. 10,010,567, serial no. 15,589,605

Aker Biomarine Antarctic AS v. Rimfrost AS, Nos. 2019-1097, 2019-1078 (Fed. Cir. Oct. 3, 2019

Final Written Decision Determining All Challenged Claims [claims 1¿¿¿32] Unpatentable and Denying Patent Owner¿¿¿s Motion to Amend, IPR2018-01178, Patent 9,375,453 B2, dated January 13, 2020.

Final Written Decision Determining All Challenged Claims [claims 1-20. i.e., all claims] Unpatentable and Denying Patent Owner¿¿¿s Motion to Amend, IPR2018-01730, Patent 9,072,752 B2, dated March 6, 2020.

Power of Attorney

DECLARATION OF DR STEPHEN J. TALLON

PETITION FOR INTER PARTES REVIEW