`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`RIMFROST AS
`
`Petitioner
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS
`
`Patent Owner
`_______________
`
`Case No.: IPR2020-01532
`
`U.S. Patent No. 9,644,169
`
`Issue Date: May 9, 2017
`
`Title: Bioeffective Krill Oil Compositions
`
`_______________
`
`PETITION FOR INTER PARTES REVIEW
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.1 ET SEQ.
`
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`Inter Partes Review Case No.: IPR2020-01532
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`TABLE OF CONTENTS
`
`U.S. Patent No. 9,644,169
`
`
`INTRODUCTION .......................................................................................... 1
`I.
`II. MANDATORY NOTICES ............................................................................ 3
`A.
`Real parties-in-interest ......................................................................... 3
`B.
`Related matters (37 C.F.R. § 42.8(b)(2)) ............................................. 3
`C.
`Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a)) .................................. 7
`D.
`Service information (37 C.F.R. § 42.8(b)(4)) ...................................... 8
`III. PATENT OFFICE FEES ................................................................................ 8
`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW ........... 9
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) .................................... 9
`B.
`Level or Ordinary Skill in the Art ........................................................ 9
`C.
`Identification of Challenge and Relief Requested
`(37 C.F.R. § 42.104(b) and 37 C.F.R. § 42.22(a)(1)) ........................ 10
`Claims for which Inter Partes Review is Requested
`1.
`(37 C.F.R. § 42.104(b)(2)) .......................................................10
`Specific Statutory Grounds on which the Challenge is
`Based (37 C.F.R. § 42.104(b)(2)) ............................................10
`Earliest Effective Priority Date ................................................ 11
`3.
`Prior Art References ................................................................11
`4.
`Claim Construction – Ordinary and Customary Meaning
`(37 C.F.R. § 42.104(b)(3)) .................................................................12
`
`2.
`
`D.
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`U.S. Patent No. 9,644,169
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`V.
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`
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`35 U.S.C. § 325(d) Does Not Preclude This Petition 13
`E.
`SUMMARY OF THE ‘169 PATENT .......................................................... 14
`A.
`State of the Art ...................................................................................15
`B.
`Prior Art ..............................................................................................19
`1.
`Breivik II (Exhibit 1037) .........................................................19
`2.
`Catchpole (Exhibit 1009) ......................................................... 21
`3.
`Budziński (Exhibit 1008) .........................................................23
`4.
`Fricke (Exhibit 1010) ...............................................................24
`5.
`Randolph (Exhibit 1011) ..........................................................25
`6.
`Sampalis I (Exhibit 1012) ........................................................27
`Background of ‘169 Patent .................................................................28
`Prosecution History of the ‘169 Patent ..............................................29
`Construction of the ‘169 Patent Claim Terms ....................................32
`1.
`Claims 1 and 12 – “krill oil” ....................................................33
`2.
`Claims 1 and 12 – “denature lipases and phospholipases” ...... 33
`3.
`Claims 1 and 12 – “polar solvent” ...........................................34
`4.
`Claims 1 and 12 – “astaxanthin ester” ..................................... 35
`5.
`Claims 4 and 14 – “krill meal” ................................................ 36
`6.
`Claims 5 and 15 – “freshly harvested krill” ............................. 38
`
`C.
`D.
`E.
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`VI. COLLATERAL ESTOPPEL PRECLUDES PATENT OWNER
`FROM ADVANCING THE SAME PATENTABILITY
`ARGUMENTS REJECTED IN 877 FWD, 905 FWD, 765 FWD,
`453 FWD AND 752 FWD ............................................................................39
`VII. EACH GROUND PROVIDES MORE THAN A REASONABLE
`LIKELIHOOD THAT EACH CLAIM OF THE ‘169 PATENT IS
`UNPATENTABLE .......................................................................................42
`A. Ground 1: § 103(a) – Breivik II, Catchpole, Budziński,
`Fricke and Randolph [Claims 1-5, 7-15, 17-20] ................................42
`1.
`Claim 1 .....................................................................................43
`(a)
`The method steps of claim 1 .......................................... 44
`(i) Providing krill .........................................................44
`(ii) Treating krill to provide a denatured product ........44
`(iii) Storing denatured krill from 1-24 months ............. 45
`(iv) Extracting krill oil with a polar solvent ................. 46
`(b) Krill oil with 3-15% ether phospholipids ......................47
`(c) Krill oil with greater than 100 mg/kg
`astaxanthin esters ...........................................................47
`Claim 12 ...................................................................................49
`(a)
`The method steps of claim 12 ........................................50
`(i) Obtaining a denatured krill product produced by
` treating freshly harvested krill and storing
` that product for 1-24 months ..................................50
`(ii) Storing denatured krill for 1-24 months .................51
`(iii) Extracting krill oil with a polar solvent .................51
`(b) Krill oil extracts with 3-15% ether phospholipids and
`greater than 100 mg/kg astaxanthin esters .....................52
`
`2.
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`B.
`
`Claim 2 .....................................................................................53
`3.
`Claims 3 and 13 ........................................................................53
`4.
`Claims 4 and 14 ........................................................................54
`5.
`Claims 5 and 15 ........................................................................55
`6.
`Claims 7 and 17 ........................................................................56
`7.
`Claims 8 and 18 ........................................................................56
`8.
`Claims 9 and 19 ........................................................................57
`9.
`10. Claims 10 and 20 ......................................................................58
`11. Claim 11 ...................................................................................59
`Ground 2: § 103(a) – Breivik II, Catchpole, Budziński,
`Fricke, Randolph and Sampalis I [Claims 6 and 16] .........................66
`1.
`Claims 6 and 16 ........................................................................66
`CLAIM CHART .................................................................................69
`C.
`VIII. CONCLUSION .............................................................................................90
`IX. Certificate of Compliance .............................................................................91
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`APPENDIX OF EXHIBITS
`
`U.S. Patent No. 9,644,169
`
`
`EXHIBIT NO. EXHIBIT DESCRIPTION
`
`1001
`
`1002
`
`
`
`U.S. Patent No. 9,644,169, issued May 9, 2017.
`
`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).
`
`Declaration of Stephen Tallon.
`
`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).
`
`Budziński, 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).
`
`
`
`- iii -
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`
`1003
`
`
`1004
`
`
`1005
`
`
`1006
`
`1007
`
`
`1008
`
`
`1009
`
`
`
`
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`Inter Partes Review Case No.: IPR2020-01532
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`
`1010
`
`U.S. Patent No. 9,644,169
`
`
`1011
`
`
`1012
`
`
`1013
`
`
`1014
`
`1015
`
`
`1016
`
`1017
`
`
`1018-1019
`
`
`
`
`Fricke et al., “Lipid, Sterol and Fatty Acid Composition of
`Antarctic Krill (Euphausia superba Dana),” LIPIDS
`19(11):821-827 (1984) (Fricke I).
`
`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).
`
`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).
`
`Reserved.
`
`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 (Tanaka 2004).
`
`Reserved.
`
`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).
`
`Reserved.
`
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`Inter Partes Review Case No.: IPR2020-01532
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`1020
`
`U.S. Patent No. 9,644,169
`
`
`1021-1022
`
`
`1023
`
`
`1024
`
`
`
`
`
`
`
`
`
`
`
`1025-1026
`
`1027
`
`
`1028
`
`
`1029
`
`
`
`
`
`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).
`
`Reserved.
`
`Federal Register Notice of Institution of Investigation 337-TA-
`1019 on September 16, 2016 by the ITC (81 Fed. Reg. pages
`63805-63806).
`
`File History to U.S. Patent No. 9,034,388 B2, Serial No,
`12/057,775 (‘388 File History)
`1024 Part 1 - Pages 1-450
`1024 Part 2 - Pages 451-900
`1024 Part 3 - Pages 901-1350
`1024 Part 4 - Pages 1351-1800
`1024 Part 5A - Pages 1801-2025
`1024 Part 5B - Pages 2026-2250
`1024 Part 6 - Pages 2251-2700
`1024 Part 7 - Pages 2701-3083
`1024 Part 8 - Pages 3084-3223.
`
`
`
`
`
`Reserved.
`
`Saether et al., “Lipolysis post mortem in North Atlantic krill”.
`Comp. Biochem. Physiol. Vol. 83B, No. 1, pp. 51-55, 1986
`(Saether).
`
`Hawley’s Condensed Chemical Dictionary, p. 893, 13th
`ed.,1997 (Hawley’s)
`
`Webster’s New Universal Unabridged Dictionary, 2nd ed., p.
`732, 1983 (Webster’s)
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`1030
`
`U.S. Patent No. 9,644,169
`
`
`1031
`
`1032
`
`
`
`1033
`
`
`1034
`
`1035
`
`
`1036
`
`
`1037
`
`
`1038
`
`
`
`
`
`Tehoharides, U.S. Patent Application Publication No.
`US/2006/0013905 A1, “Anti-Inflammatory Compositions For
`Treating Multiple Sclerosis” (Tehoharides).
`
`Reserved.
`
`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).
`
`Reserved.
`
`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).
`
`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).
`
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`1039
`
`U.S. Patent No. 9,644,169
`
`
`1040-1042
`
`1043
`
`
`1044
`
`1045
`
`1046
`
`1047
`
`
`1048
`
`
`
`
`
`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).
`
`Reserved.
`
`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.
`
`Reserved.
`
`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”
`https://www.fda.gov/downloads/Food/Ingredients
`PackagingLabeling/GRAS/NoticeInventory/ucm263930.pdf,
`see also http://wayback.archive-
`it.org/7993/20171031055610/https://www.fda.gov/downloads/F
`ood/IngredientsPackagingLabeling/GRAS/NoticeInventory/UC
`M263930.pdfdated May 26, 2007 and filed by the FDA May
`31, 2007, see Exhibit 1049 (Enzymotec).
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`
`1049
`
`U.S. Patent No. 9,644,169
`
`1050
`
`
`
`
`1051
`
`
`1052
`
`
`1053
`
`1054
`
`
`1055
`
`
`
`
`
`
`1056-1058
`
`
`
`FDA, Agency Response Letter GRAS Notice No. GRN 000226,
`https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS
`/NoticeInventory/ucm153881.htm, January 3, 2008, see also
`https://wayback.archive-
`it.org/7993/20171031031702/https://www.fda.gov/Food/Ingredi
`entsPackagingLabeling/GRAS/NoticeInventory/ucm153881.htm
`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.
`
`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.
`
`Reserved.
`
`Notice of Commission Determination ending Investigation 337-
`TA-1019, dated May 23, 2017.
`
`File History to U.S. Patent No. 9,375,453 B2, Serial No,
`14/020,162 (‘453 File History)
`
`1055 Part 1 - Pages 1-400
`1055 Part 2 - Pages 401-800
`1055 Part 3 - Pages 801-1109
`
`Reserved.
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`1059
`
`U.S. Patent No. 9,644,169
`
`
`1060
`
`
`1061
`
`
`1062
`
`
`1063
`
`
`
`
`1064-1066
`
`1067
`
`1068
`
`1069
`
`
`
`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.enz
`ymotec.com/PageIndex.asp?cc=01020403)
`(https://web.archive.org/web/20070925024521/http://www.enz
`ymotec.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,
`https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnual
`Reports/ucm148025.htm, see also https://wayback.archive-
`it.org/7993/20170404042219/https://www.fda.gov/RegulatoryI
`nformation/FOI/FOIAAnnualReports/ucm148025.htm.
`
`File History to U.S. Patent No. 9,644,170 B2, Serial No,
`15/180,439 (‘170 File History)
`1063 Part 1 - Pages 1-400
`1063 Part 2 - Pages 401-800
`1063 Part 3 – Pages 801-1107.
`
`Reserved.
`
`U.S. Patent No. 9,375,453 B2, filed September 6, 2013 (‘453).
`
`U.S. Patent No. 9,028,877 B2, filed September 18, 2014 (‘877).
`
`Krill Bill Bottle and Capsules from IRL.
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`
`1070
`
`U.S. Patent No. 9,644,169
`
`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.krillb
`ill.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/20060816050841/http://www.aqu
`asourceproducts.com:80/store/;
`https://web.archive.org/web/20060816051010/http://www.aqua
`sourceproducts.com:80/krill_oil.html;
`https://web.archive.org/web/20060506115548/
`http://www.aquasourceproducts.com:80/resources.html?osCsid
`=aee4bb3df08470be3a75bc598448dabc;
`https://web.archive.org/web/20060513152744/http://vm.cfsan.f
`da.gov/~dms/ds-oview.html). See Exhibit 1076.
`
`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,
`publication date January 24, 2008.
`
`Reserved.
`
`
`
`1071
`
`
`1072
`
`
`1073-1074
`
`
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`1075
`
`U.S. Patent No. 9,644,169
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`
`1076
`
`
`1077
`
`
`1078-1079
`
`1080
`
`
`1081-1083
`
`1084
`
`
`
`Neptune, GRAS Notice [No. GRN 000242] for “High
`Phospholipid Krill Oil”
`https://www.fda.gov/downloads/Food/IngredientsPackagingLab
`eling/GRAS/NoticeInventory/ucm269133.pdf, dated January
`18, 2008 and filed by the FDA February 4, 2008 (Neptune
`GRAS); see also https://wayback.archive-
`it.org/7993/20170607013925/https://www.fda.gov/downloads/F
`ood/IngredientsPackagingLabeling/GRAS/NoticeInventory/UC
`M269133.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.c
`om/itemdy00.asp?T1=KP1. See Exhibit 1092.
`
`Reserved.
`
`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).
`
`Reserved.
`
`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” Marine Ecology Progress
`Series, Vol. 173: 149-162 (1998) (Mayzaud).
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`1085-1088
`
`1089
`
`Reserved.
`
`U.S. Patent No. 9,644,169
`
`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=GR
`ASNotices&id=371, see also https://wayback.archive-
`it.org/7993/20170607010227/https://www.fda.gov/downloads/F
`ood/IngredientsPackagingLabeling/GRAS/NoticeInventory/UC
`M274421.pdf.
`
`Reserved.
`
`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.
`
`U.S. Patent No. 9,644,170 B2, filed June 13, 2016 (‘170)
`
`Reserved.
`
`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).
`
`Mimoun-Benarroch, et al., The Bioavailability of Astaxanthin is
`Dependent on both the Source and the Isomeric Variants of the
`molecule, Bulletin of University of Agricultural Sciences and
`Veterinary Medicine Cluj-Napoca: Food Science and
`Technology, Volume 73, Number 2, 2016, pp. 61-69(9).
`
`- xii -
`
`
`1090-1091
`
`1092
`
`
`
`
`1093
`
`1094-1096
`
`1097
`
`
`1098
`
`
`1099
`
`
`
`
`
`Inter Partes Review Case No.: IPR2020-01532
`
`
`1100
`
`U.S. Patent No. 9,644,169
`
`
`1101
`
`
`1102
`
`1103
`
`
`1104
`
`
`1105-1110
`
`1111
`
`
`1112
`
`1113
`
`
`1114
`
`1115
`
`
`1116
`
`
`
`
`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.
`
`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).
`
`Reserved.
`
`File History for U.S. Patent No. 9,644,169, serial no.
`15/180,431.
`
`U.S. Patent No. 9,816,046 issued November 14, 2017.
`
`File History for U.S. Patent No. 9,816,046, serial no.
`15/589,572.
`
`U.S. Patent No. 10,010,567, issued July 3, 2018.
`
`File History for U.S. Patent No. 10,010,567, serial no.
`15,589,605.
`
`U.S. Patent No. 9,078,905 B2, issued July 14, 2015.
`
`- xiii -
`
`
`
`U.S. Patent No. 9,644,169
`
`U.S. Patent No. 9,320,765 B2, issued April 26, 2016.
`
`U.S. Patent No. 9,072,752 B2, issued July 7, 2015.
`
`Reserved.
`
`Inter Partes Review Case No.: IPR2020-01532
`
`
`1117
`
`1118
`
`1119-1128
`
`1129
`
`Final Written Decision, IPR2018-00295, June 12, 2019, Paper
`35 (U.S. Patent No. 9,320,765).
`
`Reserved.
`
`Aker Biomarine Antarctic AS v. Rimfrost AS, Nos. 2019-1097,
`2019-1078 (Fed. Cir. Oct. 3, 2019)
`
`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 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 33–61] Unpatentable and Denying Patent Owner’s
`Motion to Amend, IPR2018-01179, 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.
`
`- xiv -
`
`
`1130-1153
`
`1154
`
`
`1155
`
`
`1156
`
`
`1157
`
`
`1158
`
`
`1159
`
`
`
`
`
`Inter Partes Review Case No.: IPR2020-01532
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`
`1160-1166
`
`1167
`
`Reserved.
`
`U.S. Patent No. 9,644,169
`
`Ballantine, J.A., Roberts, J.C., and Morris, R.J. (1980), “Marine
`Sterols. XII. The Sterols of Some Pelagic Marine Crustaceans”
`J. Exp. Mar. Biol. Ecol. 47, 25-33.
`
`
`
`
`
`
`
`
`
`
`- xv -
`
`
`
`Inter Partes Review Case No.: IPR2020-01532
`
`
`I.
`
`INTRODUCTION
`Petitioner, real party-in-interest, Rimfrost AS, a Norwegian corporation
`
`U.S. Patent No. 9,644,169
`
`with its principal place of business at Vågsplassen, 6090, Fosnavåg, Norway,
`
`petitions the Patent Trial and Appeal Board ( “Board” or “PTAB”) of the United
`
`States Patent and Trademark Office (“PTO”), pursuant to 35 U.S.C. §§ 311-319
`
`and 37 C.F.R. § 42.1 et seq., to institute an inter partes review and to find
`
`unpatentable and cancel claims 1-20 of U.S. Patent No. 9,644,169, entitled
`
`“Bioeffective Krill Oil Compositions” (“the ‘169 patent”) (Exhibit 1001) which is
`
`assigned to Aker Biomarine Antarctic AS (“Aker”).
`
`The Board should now be well versed in the subject matter recited and
`
`claimed in the challenged ‘169 patent. On six prior occasions, the Board issued
`
`Final Written Decisions finding all claims of five patents sharing the same
`
`specification and reciting identical subject matter unpatentable:
`
`•
`
`•
`
`•
`
`U.S. Patent No. 9,028,877 (“the ‘877 patent”)
`IPR2017-00746, Paper 23 (“877 FWD”);
`
`U.S. Patent No. 9,078,905 (“the ‘905 patent”)
`IPR2017-00745, Paper 24 (“905 FWD”);
`
`U.S. Patent No. 9,320,765 (“the ‘765 patent”)
`IPR2017-00295, Paper 35 (“765 FWD”);
`
`
`
`
`
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`Inter Partes Review Case No.: IPR2020-01532
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`
`
`•
`
`U.S. Patent No. 9,644,169
`
`U.S. Patent No. 9,375,453 (“the ‘453 patent”)
`IPR2018-01178, Paper 34 (“453 FWD I”)
`IPR2018-00179, Paper 34 (“453 FWD II”); and
`
`U.S. Patent No. 9,072,752 (“the ‘752 patent”)
`IPR2018-01730, Paper 35 (“752 FWD”).1
`
`In each of these Final Written Decisions, the Board evaluated claim
`
`•
`
`limitations that are materially similar, if not identical, to those recited in the
`
`claims of the ‘169 patent. For example, with the exception of a limitation directed
`
`to “a storage period of from 1 to 24 months,” all other limitations recited in the
`
`claims of the ‘169 patent were also recited in the claims of the ‘877 and ‘453
`
`patents. However, in 877 FWD, 453 FWD I and 453 FWD II the Board found all
`
`limitations recited in the claims of ‘877 and ‘453 patents were disclosed in the
`
`prior art – the very same prior art being relied on in this Petition – and determined
`
`there would have been reason to combine those known limitations in the fashion
`
`claimed by both patents, thereby rendering the ‘877 and ‘453 patents obvious.
`
`Given the materially identical claim limitations and common prior art, collateral
`
`estoppel should control the vast majority of issues needed to evaluate the
`
`
`1 The Federal Circuit affirmed 877 FWD and 905 FWD, and Patent Owner failed
`
`to seek appellate review of 453 FWD I, 453 FWD II and 752 FWD.
`
`
`
`
`2
`
`
`
`Inter Partes Review Case No.: IPR2020-01532
`
`
`patentability of the claims of the ‘169 patent.
`
`U.S. Patent No. 9,644,169
`
`At bottom, there is a reasonable likelihood that Petitioner will prevail with
`
`respect to at least one claim challenged in this Petition. Petitioner respectfully
`
`requests that the Board institute trial on all claims of the ‘169 patent.
`
`II. MANDATORY NOTICES
`A. Real parties-in-interest
`
`Olympic Holding AS, Emerald Fisheries AS, Rimfrost USA, LLC,
`
`Rimfrost New Zealand Limited, Bioriginal Food and Science Corp., and
`
`Petitioner, Rimfrost AS, are identified as the real parties-in-interest. Several other
`
`entities have a majority ownership interest in the above-identified real parties-in-
`
`interest. Based on those ownership interests, and in an abundance of caution,
`
`Petitioner also names Stig Remøy, SRR Invest AS, Rimfrost Holding AS, and
`
`Omega Protein Corporation as real parties-in-interest.
`
`B. Related matters (37 C.F.R. § 42.8(b)(2))
`
`Aker previously asserted the ‘877 and ‘905 patent in a lawsuit captioned Aker
`
`Biomarine Antarctic AS v. Olympic Holding AS; Rimfrost AS; Emerald Fisheries AS,
`
`Rimfrost USA, LLC; Avoca Inc.; and Bioriginal Food & Science Corp. Case No.
`
`
`
`
`3
`
`
`
`Inter Partes Review Case No.: IPR2020-01532
`
`
`1:16-CV-00035-LPS-CJB (D. Del.). This litigation was initially stayed in view of
`
`U.S. Patent No. 9,644,169
`
`Investigation No. 337-TA-1019 instituted by the United States International Trade
`
`Commission on September 16, 2016 as noticed in the Federal Register. The ITC
`
`proceeding was entitled In the Matter of Certain Krill Oil Products and Krill Meal
`
`for Production of Krill Oil Products and involved to the ‘877 and ‘905 patents, as
`
`well as Patent Owner’s related ‘765, ‘453 and ‘752 patents. The ITC investigation
`
`identified Olympic Holding AS, Rimfrost AS, Emerald Fisheries AS, Avoca Inc.,
`
`Rimfrost USA, LLC, Rimfrost New Zealand Limited and Bioriginal Food & Science
`
`Corp. as respondents. Exhibit 1023.
`
`On May 23, 2017, ITC Investigation No. 337-TA-1019 was terminated.
`
`Exhibit 1054. In addition, a Stipulation of Dismissal as to Avoca, Inc. was granted
`
`by the Delaware District Court on May 30, 2017.
`
`On January 27, 2017, Petitioner filed petitions in IPR2017-00745 and
`
`IPR2017-0747 requesting review of claims 1-20 of the ‘905 patent. On February 3,
`
`2017, Petitioner filed petitions in IPR2017-0746 and IPR2017-00748 requesting
`
`review of claims 1-19 of the ‘877 patent. Each was instituted on August 16, 2017.
`
`On September 6, 2017, the Delaware District Court action was stayed pending
`
`
`
`
`4
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`
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`Inter Partes Review Case No.: IPR2020-01532
`
`
`resolution of these IPRs. On August 24, 2018, the Board ruled that claims 1-20 of
`
`U.S. Patent No. 9,644,169
`
`the ‘905 patent and claims 1-19 of the ‘877 patent are unpatentable. 905 FWD
`
`(Exhibit 1103); 877 FWD (Exhibit 1104).
`
`On October 3, 2019, the U.S. Court of Appeals for the Federal Circuit, in a
`
`consolidated opinion, affirmed the Board’s Final Written Decisions in
`
`IPR2017-00745 and IPR2017-00746 finding all claims of the ‘877 and ‘905 patents
`
`unpatentable. Aker Biomarine Antarctic AS v. Rimfrost AS, 786 F. App’x 251
`
`(2019) (Exhibit 1154). On October 28, 2019, based on the Federal Circuit’s
`
`affirmance of 877 FWD and 905 FWD, the Delaware District Court action was
`
`dismissed with prejudice.
`
`In March 2020, the Patent Office issued Inter Partes Review Certificates
`
`cancelling claims 1-20 of the ‘905 patent and claims 1-19 of the ‘877 patent.
`
`Exhibits 1155, 1156.
`
`On December 15, 2017, Petitioner filed a petition in IPR2018-00295
`
`requesting review of claims 1-48 of the ‘765 patent. This IPR was instituted on June
`
`14, 2018. On June 12, 2009, the Board issued its Final Written Decision finding all
`
`claims of the ‘765 patent unpatentable. 765 FWD (Exhibit 1129). As part of its
`
`
`
`
`5
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`
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`Inter Partes Review Case No.: IPR2020-01532
`
`
`Final Written Decision, the PTAB also denied Patent Owner’s contingent Motion to
`
`U.S. Patent No. 9,644,169
`
`Amend that sought to replace claims 25-32 with substitute claims 49-56. On July
`
`12, 2019, Patent Owner filed a Request for Rehearing limited exclusively to the
`
`Board’s denial of the Motion to Amend. On November 22, 2019, the Board granted
`
`the Request for Rehearing, which is now fully briefed. The Board’s ruling on the
`
`patentability of the substitute claims remains pending.
`
`On February 9, 2018, Petitioner filed a petition in PGR2018-0033 requesting
`
`review of claims 1-20 of U.S. Patent No. 9,644,170 (“the ‘170 patent”). On August
`
`29, 2018, the Board determined that the ‘170 patent was not eligible for post grant
`
`review.
`
`On June 26, 2018, Petitioner filed petitions in IPR2018-01178 and
`
`IPR2018-01179 requesting review of claims 1-31 and claims 32-61 of the ‘453
`
`patent, respectively. Both proceedings were instituted on January 14, 2019. On
`
`January 13, 2020, the Board issued Final Written Decisions finding claims 1-31 and
`
`claims 32-61 unpatentable. 453 FWD I (Exhibit 1157); 453 FWD II (Exhibit 1158).
`
`The Board also denied Patent Owner’s contingent motions to amend. Patent Owner
`
`did not appeal either of these Final Written Decisions.
`
`
`
`
`6
`
`
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`Inter Partes Review Case No.: IPR2020-01532
`
`
`
`U.S. Patent No. 9,644,169
`
`On September 21, 2018, Petitioner filed a petition in IPR2018-01730
`
`requesting review of claims 1-20 of the ‘752 patent. This IPR was instituted on May
`
`12, 2019. On March 6, 2020, the Board issued a Final Written Decision finding
`
`claims 1-20 unpatentable, and denied Patent Owner’s contingent motion to amend.
`
`765 FWD (Exhibit 1159). Patent Owner did not appeal the Board’s decision.
`
`On September 30, 2020, Petitioner filed a petition in IPR2020-01533
`
`requesting review of claims 1-19 of U.S. Patent No. 9,816,046 (“the ‘046 patent”).
`
`The ‘046 patent, like the ‘169 patent, is in the same patent family and shares a
`
`common specification with the ‘877, ‘905, ‘765, ‘453 and ‘752 patents which have
`
`already been adjudicated unpatentable.
`
`C. Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a))
`Petitioner designates the following individuals as its lead counsel and back-
`
`up lead counsel:
`
`
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