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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`RIMFROST AS
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`Petitioner
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`v.
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`AKER BIOMARINE ANTARCTIC AS
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`Patent Owner
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`Case No.: IPR2018-01178
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`U.S. Patent 9,375,453
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`Issue Date: June 28, 2016
`
`Title: Methods for Producing Bioeffective Krill Oil Compositions
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`PETITION FOR INTER PARTES REVIEW
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`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.1 ET SEQ.
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`TABLE OF CONTENTS
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`I. THE PETITION ................................................................................................. 1
`II. MANDATORY NOTICES ................................................................................ 1
`A.
`Real Parties-in-Interest .......................................................................... 1
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) .............................................. 2
`C.
`Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a)) ................................... 4
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 4
`III. PAYMENT OF FEES ........................................................................................ 5
`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW .............. 6
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) ..................................... 6
`B.
`Level of Ordinary Skill in the Art ......................................................... 6
`C.
`Identification of Challenge and Relief Requested
`(37 C.F.R. § 42.104(b) and 37 C.F.R. § 42.22(a)(1)) ........................... 7
`1.
`Claims for which Inter Partes Review is Requested
`(37 C.F.R. § 42.104(b)(2)) .......................................................... 7
`Specific Statutory Grounds on which the Challenge is Based
`(37 C.F.R. § 42.104(b)(2)) .......................................................... 7
`Earliest Effective Priority Date ................................................... 8
`3.
`Prior Art References.................................................................... 9
`4.
`Claim Construction-Broadest Reasonable Interpretation (“BRI”)
`(37 C.F.R. § 42.104(b)(3)) ..................................................................11
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`D.
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`2.
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`V. SUMMARY OF THE ‘453 PATENT (EXHIBIT 1001) ................................12
`A.
`Background of the ‘453 Patent ............................................................12
`B.
`Prosecution History of the ‘453 Patent ...............................................14
`C.
`Construction of the ‘453 Patent Claim Terms.....................................16
`1.
`Claims 1-10, 12-17, 19-20, 22-26, 28-29 - “polar krill oil” .....16
`2.
`Claim 1 - “polar solvent” ..........................................................19
`3.
`Claim 1 - “denature lipases and phospholipases” ....................21
`4.
`Claims 13, 22, 29 - “plant phytonutrient” .................................24
`5.
`Claims 1, 7-9, 15-16, 19, 24-25, 28 - “astaxanthin esters” .......25
`6.
`Claim 23-“greater than about 5% w/w ether phospholipids” ...27
`7.
`Claim 2 -“greater than about 40% ether
`phosphotidylcholine” ................................................................31
`VI. EACH GROUND PROVIDES MORE THAN A REASONABLE
`LIKELIHOOD THAT CHALLENGED CLAIMS 1-32 OF THE ‘453
`PATENT ARE UNPATENTABLE .................................................................32
`A. Ground 1: Section 103(a) - Breivik II, Catchpole,
`Bottino II and Sampalis I [Claims 1-3, 5-10, 12, 14-17, 19-20,
`23-26, 28, 30-32] .................................................................................33
`B. Ground 2: Section 103(a) - Breivik II, Catchpole,
`Bottino II, Sampalis I and Sampalis II
`[Claim 4] ..............................................................................................56
`C. Ground 3: Section 103(a) - Breivik, Catchpole,
`Bottino II, Sampalis I, Sampalis II and Fricket
`[Claims 11, 18, 21, 27] .......................................................................60
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`D. Ground 4: Section 103(a) - Breivik II, Catchpole, Bottino II,
`Sampalis I and Randolph
`[Claims 13, 22, 29] ..............................................................................64
`Claim Chart .........................................................................................66
`E.
`VII. CONCLUSION ................................................................................................90
`VIII. CERTIFICATE OF COMPLIANCE ...............................................................91
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`EXHIBIT NO.
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`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`APPENDIX OF EXHIBITS
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`EXHIBIT DESCRIPTION
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`U.S. Patent No. 9,375,453, filed September 6, 2013 (‘453
`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)
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`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)
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`iv
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`1010
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`1011
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`1012
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`1013
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`1014
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`1015
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`1016
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`1017
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`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)
`
`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)
`
`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)
`
`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)
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025-1026
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`1027
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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
`
`Reserved
`
`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
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`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 5 - Pages 1801-2250
`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)
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`vi
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`1028
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`1029
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`1030
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`1031
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`1032
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`1033
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`1034
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`1035
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`1036
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`Hawley’s Condensed Chemical Dictionary, p. 893, 13th ed.,
`1997 (Hawley’s)
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`Reserved
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`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)
`
`Reserved
`
`Breivik, U.S. Patent Application Publication No. US
`2010/0143571 A1, “Process for Production of Omega-3 Rich
`Marine Phospholipids from Krill,” (Breivik)
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`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)
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`1037
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`1038
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`1039
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`1040-1042
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`1043
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`1044-1046
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`1047
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`1048
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`1049
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`1050-1053
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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)
`
`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)
`
`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. 9,034,388)
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`Reserved
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`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,
`dated May 26, 2007 and filed by the FDA May 31, 2007, see
`Exhibit 1049 (Enzymotec)
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`FDA, Agency Response Letter GRAS Notice No. GRN 000226,
`https://www.fda.gov/Food/IngredientsPackagingLabeling/GRA
`S/NoticeInventory/ucm153881.htm, January 3, 2008
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`Reserved
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`U.S. Patent No. 9,375,453
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`1054
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`1055
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`1056-1058
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`1059
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`1060-1062
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`1063
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`1064-1068
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`1069
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`1070
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`Notice of Commission Determination ending Investigation 337-
`TA-1019, dated May 23, 2017
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`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
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`Reserved
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`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
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`Reserved
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`File History to U.S. Patent No. 9,644,170 B2, Serial No,
`15/180,439 (‘170 File History)
`Part 1 - Pages 1-400
`1063 Part 2 - Pages 401-800
`1063 Part 3 – Pages 801-1107
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`Reserved
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`Krill Bill Bottle and Capsules from IRL
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`Krill Bill Online Purchase Order and Specification Pages from
`2006
`(https://web.archive.org/web/20060715103715/http://www.krill
`bill.com:80/purchase.htm;
`https://web.archive.org/web/20060715103809/http://www.krill
`bill.com/profile.htm)
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`IPR2018-01178
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`1071
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`1072
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`1073-1074
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`1075
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`1076
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`1077
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`1078
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`U.S. Patent No. 9,375,453
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`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.fd
`a.gov/~dms/ds-oview.html)
`
`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
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`Reserved
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`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)
`
`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
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`Reserved
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`Del. District Court Stay of 16-cv-00035, pending resolution of
`IPRs, Order dated September 6, 2017
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`IPR2018-01178
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`1079-1083
`1084
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`1085-1088
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`1089
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`1090-1092
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`1093
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`1094
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`1095
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`1096
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`1097
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`1098
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`U.S. Patent No. 9,375,453
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`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)
`
`Reserved
`
`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
`
`Reserved
`
`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
`
`Stremler, et al., Human Plasma Platelet-activating Factor
`Acetylhydrolase - Oxidatively Fragmented Phospholipids As
`Substrates, (1991) J. Biol. Chem. 266, 11095–11103
`
`Reserved
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`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)
`xi
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`U.S. Patent No. 9,375,453
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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, Bulletin of University of Agricultural Sciences and
`Veterinary Medicine Cluj-Napoca: Food Science and
`Technology, Volume 73, Number 2, 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
`
`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
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`IPR2018-01178
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`IPR2018-01178
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`I.
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`THE PETITION
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`
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`U.S. Patent No. 9,375,453
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`Petitioner, real party-in-interest, Rimfrost AS, a Norwegian corporation,
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`with its principal place of business at Vågsplassen, 6090, Fosnavåg, Norway,
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`hereby petitions the Patent Trial and Appeal Board (the “Board” or the “PTAB”) of
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`the United States Patent and Trademark Office (“PTO”), pursuant to 35 U.S.C. §§
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`311-319 and 37 C.F.R. § 42.1 et seq., to institute an inter partes review and to find
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`unpatentable and cancel claims 1-32 of U.S. Patent No. 9,375,453 entitled
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`“Methods for Producing Bioeffective Krill Oil Compositions” (“the ‘453 patent”).
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`The ‘453 patent issued on June 28, 2016 (Serial No. 14/020,162), was filed
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`September 6, 2013, and was assigned to Aker Biomarine Antarctic AS (“Aker”).
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`The ‘453 patent is submitted herewith as Exhibit 1001. There is a reasonable
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`likelihood that Petitioner will prevail with respect to at least one claim challenged
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`in this petition.
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`II. MANDATORY NOTICES
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`A. Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1))
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`Olympic Holding AS, Emerald Fisheries AS, Rimfrost USA, LLC, Rimfrost
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`New Zealand Limited, Bioriginal Food and Science Corp., and Petitioner, Rimfrost
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`AS, are identified as the real parties-in-interest. Several other entities have a
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`majority ownership interest in the above-identified real parties-in-interest. Based
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`IPR2018-01178
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`upon those ownership interests, and in an abundance of caution, Petitioner also
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`U.S. Patent No. 9,375,453
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`names Stig Remøy, SRR Invest AS, Rimfrost Holding AS, and Omega Protein
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`Corporation as real parties-in-interest.
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`B. Related Matters (37 C.F.R. § 42.8(b)(2))
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`Aker has asserted two patents - U.S. Patent Nos. 9,078,905 and 9,028,877 in
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`a pending litigation commenced by Aker against Olympic Holding AS; Rimfrost
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`AS; Emerald Fisheries AS, Rimfrost USA, LLC; Avoca Inc.; and Bioriginal Food
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`& Science Corp. See Case No. 1:16-CV-00035-LPS-CJB (D. Del.). (Complaint,
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`Exhibit 1021). The litigation was stayed pursuant to 28 U.S.C. § 1659 in view of
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`Investigation No. 337-TA-1019 instituted by the U.S. International Trade
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`Commission on September 16, 2016. The ITC proceeding, In the Matter of
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`Certain Krill Oil Products and Krill Meal for Production of Krill Oil Products,
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`related to Aker’s U.S. Patent Nos. 9,028,877, 9,078,905, 9,072,752, 9,320,765, and
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`9,375,453. The ITC Investigation identified Olympic Holding AS, Rimfrost AS,
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`Emerald Fisheries AS, Avoca Inc., Rimfrost USA, LLC, Rimfrost New Zealand
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`Limited and Bioriginal Food & Science Corp. as respondents. (Exhibit 1023). On
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`May 23, 2017, ITC Investigation No. 337-TA-1019 was effectively terminated.
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`IPR2018-01178
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`(Exhibit 1054). In addition, a Stipulation of Dismissal as to Avoca Inc. was
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`U.S. Patent No. 9,375,453
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`granted by the Delaware District Court on May 30, 2017.
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`On January 27, 2017, Petitioner filed petitions in IPR2017-0745 and
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`IPR2017-0747 requesting review of claims 1-20 of U.S. Patent No. 9,078,905. On
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`February 3, 2017, Petitioner filed petitions in IPR2017-0746 and IPR2017-0748
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`requesting review of claims 1-19 of U.S. Patent No. 9,028,877. Each of these IPRs
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`was instituted on August 16, 2017. On September 6, 2017, the Delaware District
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`Court action was stayed pending resolution of the IPRs. (Exhibit 1078).
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`On December 15, 2017, Petitioner filed a petition in IPR2018-00295
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`requesting review of claims 1-48 of U.S. Patent No. 9,320,765. This IPR was
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`instituted on June 14, 2018.
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`On February 9, 2018, Petitioner filed a petition in PGR2018-0033 requesting
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`review of claims 1-20 of U.S. Patent No. 9,644,170. The Board has not yet issued
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`an Institution Decision for this review.
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`Contemporaneously with the filing of this Petition, Petitioner is also filing a
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`Petition in IPR2018-01179 requesting review and cancellation of claims 33-61 of
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`the ‘453 patent.
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`3
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`C. Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a))
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`Petitioner designates the following individuals as its lead counsel and back-
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`up lead counsel:
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`Lead Counsel:
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`First Back-Up Counsel:
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`James F. Harrington
`Reg. No. 44,741
`Hoffmann & Baron, LLP
`jfhdocket@hbiplaw.com
`(516) 822-3550
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`
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`
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`
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`Michael I. Chakansky
`Reg. No. 31,600
`Hoffmann & Baron, LLP
`micdocket@hbiplaw.com
`(973) 331-1700
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`Additional Back-Up Counsel:
`
`Ronald J. Baron
`Reg. No. 29,281
`Hoffmann & Baron, LLP
`rjbdocket@hbiplaw.com
`(516) 822-3550
`
`John T. Gallagher
`Reg. No. 35,516
`Hoffmann & Baron, LLP
`jtgdocket@hbiplaw.com
`(516) 822-3550
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`Service Information (37 C.F.R. § 42.8(b)(4))
`
`D.
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`Service on Petitioner may be made electronically by using the following e-
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`mail address: 453ipr@hbiplaw.com and the e-mail addresses above. Service on
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`4
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`IPR2018-01178
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`Petitioner may be made by Postal Mailing or Hand-Delivery addressed to Lead and
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`U.S. Patent No. 9,375,453
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`
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`First Back-U Counsel at the following address, but electronic service above is
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`requested:
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`Hoffmann & Baron, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
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`This document, together with all referenced exhibits has been served on the
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`patent owner at its corporate headquarters, Oskenøyveien 10 No-1327, 1366
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`Lysaker, Norway, and the correspondence address of record for the ‘453 patent:
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`Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton, Wisconsin 53562.
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`III.
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`PAYMENT OF FEES
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`Pursuant to 37 C.F.R. §§ 42.103 and 42.15(a), the requisite filing fee of
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`$44,300 (request fee of $15,500, post-institution fee of $15,000, excess claims fee
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`of $3,600 and excess post-institution claims fee of $10,200) is submitted herewith.
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`Claims 1-32 of the ‘453 patent are being reviewed as part of this Petition. The
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`undersigned further authorizes payment from Deposit Account No. 08-2461 for
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`any additional fees or refund that may be due in connection with this Petition.
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`5
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`IPR2018-01178
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`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW
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`U.S. Patent No. 9,375,453
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`
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`A. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Petitioner certifies that the ‘453 patent is available for Inter Partes Review
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`and that Petitioner is not barred or estopped from requesting Inter Partes Review
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`challenging claims 1-32 of the ‘453 patent on the grounds identified herein.
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`Level or Ordinary Skill in the Art
`
`B.
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`As of the ‘453 patent’s earliest effective filing date, a person of ordinary skill
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`in the art (“POSITA”) would have held an advanced degree in marine sciences,
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`biochemistry, organic (especially lipid) chemistry, chemical or process
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`engineering, or associated sciences with complementary understanding, either
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`through education or experience, of organic chemistry and in particular lipid
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`chemistry, chemical or process engineering, marine biology, nutrition, or
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`associated sciences; and knowledge of or experience in the field of extraction. In
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`addition, a POSITA would have had at least five years applied experience.
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`(Declaration of Dr. Stephen Tallon, hereafter “Tallon (Exhibit 1006)”, ¶¶ 30-31).
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`IPR2018-01178
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`C.
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`U.S. Patent No. 9,375,453
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`Identification of Challenge and Relief Requested
`(37 C.F.R. § 42.104(b) and 37 C.F.R. § 42.22(a)(1))
`
`
`The precise relief requested by Petitioner is that claims 1-32 are found
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`unpatentable and cancelled from the ‘453 patent.
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`1.
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`Claims for which Inter Partes Review is Requested
`(37 C.F.R. § 42.104(b)(2))
`Petitioner requests Inter Partes Review of claims 1-32 of the ‘453 patent.
`
`2.
`
`Specific Statutory Grounds on which the Challenge is
`Based (37 C.F.R. § 42.104(b)(2))
`The specific statutory grounds for the challenge are as follows:
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`Reference(s)
`
`Basis
`
`
`
`Ground
`
`1
`
`2
`
`3
`
`4
`
`Breivik II, Catchpole,
`Bottino II and
`Sampalis I
`Breivik II, Catchpole,
`Bottino II, Sampalis I
`and Sampalis II
`Breivik II, Catchpole,
`Bottino II, Sampalis I
`and Fricke
`Breivik II, Catchpole,
`Bottino II, Sampalis I
`and Randolph
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`35 U.S.C. § 103(a)
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`35 U.S.C. § 103(a)
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`Claims
`Challenged
`1-3, 5-10, 12, 14-
`17, 19-20, 23-26,
`28, 30-32
`4
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`35 U.S.C. § 103(a)
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`11, 18, 21, 27
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`35 U.S.C. § 103(a)
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`13, 22, 29
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`
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`Petitioner also relies on the expert declaration of Dr. Stephen Tallon (Exhibit
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`1006).
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`7
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`IPR2018-01178
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`3.
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`
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`U.S. Patent No. 9,375,453
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`Earliest Effective Priority Date
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`The ‘453 patent is a continuation of U.S.S.N. 12/057,775, filed on March 28,
`
`2008, now U.S. Patent No. 9,034,388. The ‘453 patent claims priority to the
`
`following U.S. Provisional Applications: 60/920,483, filed March 28, 2007;
`
`60/975,058, filed September 25, 2007; 60/983,446, filed October 29, 2007; and
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`61/024,072, filed January 28, 2008. All of the issued claims in the ‘453 patent
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`include the element that the recited krill oil comprise greater than about 3% w/w
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`ether phospholipids. Support of the “ether phospholipid” claim element - recited in
`
`each ‘453 patent claim - was not introduced until the filing of U.S. Provisional
`
`Application 61/024,072 on January 28, 2008. (See Exhibits 1002-1005). In fact,
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`there was no mention of ether phospholipids until the January 28, 2008
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`Provisional. Consequently, the earliest effective priority date for the claims of the
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`‘453 patent is no earlier than January 28, 2008. (Tallon (Exhibit 1006), ¶¶ 64-65).
`
`Additionally, the ‘453 patent, at most, discloses that the purported invention
`
`includes krill oil extracts having an ether phospholipid content of 7.4% by weight
`
`of krill oil. (Exhibit 1001). However, as explained below, all of the ‘453 patent
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`claims recite percentages of ether phospholipids having open-ended ranges of
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`“greater than” 3%, 4% and 5% with no express upper limit. None of the
`8
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`IPR2018-01178
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`referenced priority documents (Exhibits 1002-1005, 1024, or 1047) contain any
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`U.S. Patent No. 9,375,453
`
`
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`written description of the full range, or even a substantial portion of the range of
`
`ether phospholipid percentages of the claimed krill oil. Thus, lacking adequate
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`written enabling disclosure, the ‘453 patent is not entitled to a priority date earlier
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`than its filing, namely September 6, 2013. (Tallon (Exhibit 1006), ¶¶ 66-84).
`
`4.
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`Prior Art References
`
`Other than Catchpole and Breivik II, all prior art references utilized herein
`
`were published more than one year before the earliest possible priority date of
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`January 28, 2008, and therefore qualify as prior art under 35 U.S.C. § 102(b).
`
`Catchpole (Exhibit 1009) has an international filing date of April 20, 2007, was
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`published on November 1, 2007, and qualifies as a prior art reference under 35
`
`U.S.C. § 102(e). Breivik II (Exhibit 1037) was filed as a PCT application, in
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`English, designating the United States, on November 15, 2007, and claims priority
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`9
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`IPR2018-01178
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`to Provisional Application No. 60/859,289 (Exhibit 1036) filed November 16,
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`U.S. Patent No. 9,375,453
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`
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`2006. Breivik II qualifies as a prior art reference under 35 U.S.C. § 102(e).1
`
`§ 102(b) Reference
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`Publication Date
`
`Exhibit No.
`
`Sampalis I
`
`Fricke
`
`Bottino II
`
`Randolph
`
`May 2003
`
`April 30, 1984
`
`1975
`
`March 17, 2005
`
`Sampalis II
`
`February 12, 2003
`
`1012
`
`1010
`
`1038
`
`1011
`
`1013
`
`
`
`§ 102(e) Reference
`
`Effective Filing Date
`
`Exhibit No.
`
`Catchpole
`
`Breivik II
`
`April 20, 2007
`
`November 16, 2006
`
`1009
`
`1037
`
`
`
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`
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`1 Catchpole and Breivik II are prior art under 35 U.S.C. § 102(a) and, based on the
`
`‘453 patent’s earliest effective filing date of September 6, 2013, are also prior art
`
`under 35 U.S.C. § 102(b).
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`10
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`D. Claim Construction-Broadest Reasonable Interpretation
`(“BRI”) (37 C.F.R. § 42.104(b)(3))
`
`
`In an inter partes review, the Board interprets claim terms in an unexpired
`
`patent according to the broadest reasonable construction in light of the
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo
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`Speed Techs. v. Lee, LLC, 136 S. Ct. 2131, 2142-46 (2016).2 Under this standard,
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`and absent any special definitions, claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the art at
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`the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
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`Cir. 2007). Any special definitions for claim terms must be set forth with
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`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475,
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`1480 (Fed. Cir. 1994).
`
`
`2 On May 8, 2018 the PTO announced proposed rule changes that a Phillips claim
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`construction would be used to construe claim terms in an inter partes review
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`proceeding instead of the broadest reasonable interpretation currently used. Such a
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`change would not affect the construction of the claim terms in this Petition with the
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`possible exception of “astaxanthin” and “astaxanthin esters.” (Infra, pp. 24-26).
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`11
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`IPR2018-01178
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`V.
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`
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`U.S. Patent No. 9,375,453
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`SUMMARY OF THE ‘453 PATENT (EXHIBIT 1001)
`
`Background of the ‘453 Patent
`
`A.
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`The ‘453 patent “provides methods of production of krill oil comprising: a)
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`providing fresh krill; b) treating said fresh krill to denature lipases and
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`phospholipases in said fresh krill to provide a denatured krill product; and c)
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`extracting oil from said denatured krill product. In some embodiments, the
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`denaturation step comprises heating of fresh krill.” (Exhibit 1001, 4:47-53). As
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`acknowledged in the Background of the Invention:
`
`In order to isolate the krill oil from the krill, solvent
`extraction methods have been used. See, e.g., WO
`00/23546. Krill lipids have been extracted by placing the
`material in a ketone solvent (e.g. acetone) in order to
`extract the lipid soluble fraction. This method involves
`separating the liquid and solid contents by evaporation.
`Further processing steps include extracting and
`recovering by evaporation the remaining soluble lipid
`fraction from the solid contents by using a solvent such
`as ethanol. See e.g., WO 00/23546.
`(Exhibit 1001, 1:31-40).
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`12
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`IPR2018-01178
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`U.S. Patent No. 9,375,453
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`Applicants concede that “[t]he methods described above rely on the
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`processing of frozen krill that are transported from the Southern Ocean to the
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`processing site. This transportation is both expensive and can result in degradation
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`of the krill starting material.” (Exhibit 1001, 2:3-6).
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`Applicants also recognize that “[s]upercritical fluid extraction with solvent
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`modifier has previously been used to extract marine phospholipids from salmon
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`roe, but has not been previously used to extract phospholipids from krill meal.”
`
`(Exhibit 1001, 1:65-2:2). However, this statement is clearly false based upon, inter
`
`alia, the disclosure of Catchpole (Exhibit 1009) discussed below. See also
`
`Halliday, “Neptune-Degussa Deal to Develop Phospholipids, Adapt Krill Oil,”
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`http://www.nutraingredients-usa.com/Suppliers2/Neptune-Degussa-deal-to-
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`develop-phospholipids-adapt-krill-oil, December 12, 2005 (Exhibit 1031), p. 0002
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`(“Degussa is renowned for its expertise in supercritical CO2 extraction.”)).
`
`Applicants also acknowledge that “[a] krill oil composition has been
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`disclosed comprising a phospholipid and/or a flavonoid. The phospholipid content
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`in the krill lipid extract could be as high as 60% w/w and the EPA/DHA content as
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`high as 35% (w/w). See, e.g., WO 03/011873.” (Exhibit 1001, 1:53-56).
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`13
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`U.S. Patent No. 9,375,453
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`IPR2018-01178
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`Prosecution History of the ‘453 Patent
`
`B.
`
`The ‘453 patent issued on June 28, 2016 from U.S.S.N. 14/020,162 filed on
`
`September 6, 2013. The ‘453 patent is a continuation of U.S.S.N. 12/057,775 filed
`
`on March 28, 2008 and claims the benefit of four U.S. Provisional Applications:
`
`61/024,072 filed January 28, 2008; 60/983,446 filed October 29, 2007; 60/975,058
`
`filed September 25, 2007; and 60/920,483 filed March 28, 2007.
`
`On July 8, 2015, the Examiner issued a non-final Office Action rejecting all
`
`of the pending claims, i.e., claims 1-11. The claims were rejected under 35 U.S.C.
`
`§ 112, second paragraph as being indefinite. In addition, the Examiner rejecte
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