Rimfrost AS et al. vs AKER BIOMARINE ANTARCTIC AS

Judgment Final Written Decision Determining All Challenged Claims Unpatentable Denying Patent Owner’s Motion to Amend

Hearing Transcript

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

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

PETITIONER'S SECOND UPDATED EXHIBIT LIST

Deposition of Dr. Hoem, November 8, 2019 (IPR2018-01730)

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

ORDER Oral Hearing 37 C.F.R. ¿¿ 42.70

PATENT OWNER'S REQUEST FOR ORAL ARGUMENT

PETITIONER'S REQUEST FOR ORAL ARGUMENT

EXPUNGED

AKER BIOMARINE ANTARCTIC AS EXHIBIT LIST

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

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

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

Deposition of Dr. Stephen J. Tallon dated October 7, 2019

PETITIONER'S NOTICE OF DEPOSITION OF DR. NILS HOEM

PETITIONER'S SECOND UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

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

NOTICE OF STIPULATION OF NEW DUE DATES 3, 4 AND 5

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 (IPR2017-00745, inter alia)

NZ546681 WO2007123424.

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).

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

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.

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).

U.S. Patent No. 8,372,812, Tilseth & Hoem, et al., "Phospholipid and Protein Tablets,"("Tilseth").

USP42-NF37, "Krill Oil Capsules".

Deposition of Dr. Hoem, August 15, 2019 (IPR2018-01730).

Declaration of Robert S. McQuate (IPR2018-00295).

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

Reply and Opposition Declaration of Dr Stephen J. Tallon (IPR2018-01730)

PETITIONER'S FIRST UPDATED EXHIBIT LIST

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

PETITIONER'S FIRST UPDATED SUBMISSION OF MANDATORY NOTICE INFORMATION

PETITIONER'S NOTICE OF DEPOSITION OF DR. NILS HOEM

Patent Owner Response to Petition

Yamaguchi, 1986

Calder, 2006

Fricke, 1986

Zierenberg, 1982

PATENT OWNER¿¿¿S CONTINGENT MOTION TO AMEND

Patent Owner Exhibit List

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

Prescott, 2000

Zimmerman, 2002

U.S. Patent No. 4,814,111

WO 2007/136281

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

Blank, 1992

Hartvigsen, 2006

Marathe, 1999

U.S. Appl. 14/020,784 as filed

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

Patent Abstract JP 04-057853 published February 25, 1992 (Tsuneo)

US Pat. Publ. 2006/0193962 (Kamiya)

Transcript of Deposition of Dr. Stephen Tallon, June 4, 2019

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

Conduct of the Proceeding - Oral Hearing

Order - Conduct of the Proceeding - 37 CFR 42.5 and 42.121(a)

PATENT OWNERS NOTICE OF DEPOSITION OF DR. STEPHEN J. TALLON

Trial Instituted Document

Scheduling Order

Patent Owner's Mandatory Notice

Patent Owner's Power of Attorney

Certificate of Service

Notice of Accord Filing Date

Petitioner's Power of Attorney

U.S. Patent No. 9,072,752 B1, filed February 12, 2015 (¿¿¿752)

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,¿¿¿ 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)

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

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

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 [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)

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)

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)

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 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 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)

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

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)

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

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

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

File History to U.S. Patent No. 9,072,752 B1, Serial No, 14/620,784 (¿¿¿752 File History)

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

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

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

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 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 5B - Pages 2026-2250 - 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)

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)

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. of 9,034,388)

Declaration of Robert S. McQuate

Declaration of Rakesh Kapoor

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, see Exhibit 1049 (Enzymotec)

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)

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

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)

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.

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

FDA, Freedom of Information Annual Report 2007, 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 (¿¿¿170 File History)

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

Krill Bill Bottle and Capsules from IRL

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

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 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).

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

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

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

Mimoun-Benarroch, et al., The Bioavailability of Astaxanthin is Dependent on both the Source and the Isomeric Variants of the molecule, Food Science and Technology, Volume 73, Number 2, 2016, pp. 61-69(9)

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.

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)

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

Declaration of Dr. Nils Hoem in Support of Patent Owner¿¿¿s Motion to Amend, Exhibit 2013 in IPR2018-00295 (U.S. Patent No. 9,320,765)

Affidavit of Christopher Butler, Office Manager of Internet Archive, 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

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).

Mayzaud et al, ¿¿¿Changes in lipid composition of the Antarctic krill Euphausia superba . . . i: influence of geographical location, sexual maturity stage and distribution among organs¿¿¿ Marine Ecology Progress Series, Vol. 173: 149-162 (1998) (Mayzaud)

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

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

Britton, G., Structure and properties of carotenoids in relation to function, FASEB J, 9, 1551-1558,1995

Yuan, ¿¿¿Characteristics and chromatographic separation of astaxanthin and its esters from the microalga Haematococcus pluvialos,¿¿¿ Doctoral Thesis, The University of Hong Kong, 1999 (http://dx.doi.org/10.5353/th_b3123971)

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

Lambertsen, et al., Method of Analysis of Astaxanthin and its Occurrence in some Marine Products, J. Sci. of Food and Agriculture, 1971, Vol. 22, February.

Declaration of Stephen Tallon

PETITION FOR INTER PARTES REVIEW