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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.: IPR 2018-00295
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`U.S. Patent 9,320,765
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`Issue Date: April 26, 2016
`
`Title: 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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`Inter Partes Review Case No.: IPR 2018-00295
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`U.S. Patent No. 9,320,765
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`TABLE OF CONTENTS
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`THE PETITION ............................................................................................... 1
`
`I.
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`II. MANDATORY NOTICES ............................................................................. 1
`
`
`A.
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`Real Parties-in-Interest .......................................................................... 1
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`B.
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`C.
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`D.
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`Related Matters (37 C.F.R. § 42.8(b)(2)) .............................................. 2
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`Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a)) ................................... 3
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`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 4
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`III. PAYMENT OF FEES ..................................................................................... 5
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`IV. ADDITIONAL REQUREMENTS FOR INTER PARTES REVIEW ............. 6
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`A. Grounds for Standing (37 C.F.R. § 42.104(a)) ..................................... 6
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`B.
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`C.
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`Level or Ordinary Skill in the Art ......................................................... 6
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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)) ........................... 7
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`1.
`
`2.
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`Claims for which Inter Partes Review is Requested
`(37 C.F.R. § 42.104(b)(2)) .......................................................... 7
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`Specific Statutory Grounds on which the Challenge is
`Based (37 C.F.R. § 42.104(b)(2)) ............................................... 7
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`Inter Partes Review Case No.: IPR 2018-00295
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`U.S. Patent No. 9,320,765
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`V.
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`3.
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`4.
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`Earliest Effective Priority Date ................................................... 8
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`Prior Art References.................................................................... 9
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`D.
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`Claim Construction-Broadest Reasonable Interpretation
`(“BRI”) (37 C.F.R. § 42.104(b)(3)) ....................................................11
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`SUMMARY OF THE ‘765 PATENT (EXHIBIT 1001) ..............................11
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`A.
`
`B.
`
`C.
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`Background of the ‘765 Patent ............................................................11
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`Prosecution History of the ‘765 Patent ...............................................13
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`Construction of the ‘765 Patent Claim Terms.....................................17
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`1.
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`2.
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`3.
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`4.
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`5.
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`Claims 1-48 – “krill oil” ...........................................................18
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`Claims 25 – “safe and effective amount of
`Euphausia superba krill oil” .....................................................20
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`Claims 7, 17, 24, 32, 41, 48 - “plant phytonutrient” .................21
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`Claims 1-4, 10-11, 14, 19-20, 23, 25-28, 34-35, 38, 43-44,
`and 47– “astaxanthin esters” .....................................................22
`
`Claims 18 and 42 – “greater than about 5% w/w ether
`phospholipids” ..........................................................................24
`
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`VI. EACH GROUND PROVIDES MORE THAN A REASONABLE
`LIKELIHOOD THAT EACH CLAIM OF THE ‘765 PATENT IS
`UNPATENTABLE ........................................................................................27
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`Inter Partes Review Case No.: IPR 2018-00295
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`U.S. Patent No. 9,320,765
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`A. Ground 1: § 103(a) – Sampalis I, Catchpole, Fricke, and Breivik II
`[Claims 1-4, 7, 9-11, 14, 18-20, 25-28, 31, 33-35, 38,
`42-44, and 47] ......................................................................................28
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`B. Ground 2: § 103(a) – Sampalis I, Catchpole, Fricke, Breivik II,
`and Bottino I [Claims 5-6, 12-13, 15-16, 21-23, 29-30, 36-37,
`39-40, and 45-46] ................................................................................47
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`C. Ground 3: § 103(a) – Sampalis I, Catchpole, Fricke, Breivik II,
`and Randolph [Claims 8, 17, 24, 32, 41, and 48] ................................56
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`D.
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`Claim Chart .........................................................................................61
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`VII. CONCLUSION ..............................................................................................74
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`VIII. CERTIFICATE OF COMPLIANCE ............................................................75
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`U.S. Patent No. 9,320,765
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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
`
`U.S. Patent No. 9,320,765 B2, filed September 6, 2013 (‘765)
`
`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)
`
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`iv
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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)
`
`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)
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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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`Kochian et al., “Agricultural Approaches to Improving
`Phytonutrient Content in Plants: An Overview,” Nutrition Reviews,
`Vol. 57, No. 9, September 1999: S13-S18
`
`Porzio et al., “Encapsulation Compositions and Processes for
`Preparing the Same,” U.S. Patent No. 7,488,503 B1 filed March 31,
`2004 (“Porzio”)
`
`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
`
`Affidavits of Service Filed in Aker Biomarine Antarctic AS v.
`Olympic Holding AS, et al., Case No. 1:16-cv-00035
`
`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
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`Reserved
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`U.S. Patent No. 9,320,765
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`1027
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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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`1037
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`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)
`
`Tehoharides, U.S. Patent Application Publication No.
`US/2006/0013905 A1, “Anti-Inflammatory Compositions For
`Treating Multiple Sclerosis,” (Tehoharides)
`
`Reserved
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`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 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).
`vii
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`U.S. Patent No. 9,320,765
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`1038
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`1039
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`1040-
` 1041
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`1042
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`1043-
` 1045
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`1046
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`1047
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`1048
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`1049
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`
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`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
`
`
`Clarke, A., “The biochemical composition of krill, Euphausia
`superba Dana, from South Georgia,” Journal of Experimental
`Marine Biology and Ecology, Vol. 43, pp. 221-236 (1980)
`
`Reserved
`
`
`Watanabe, K., et al., “Studies on the utilization of Antarctic krill,
`Euphausia superba Dana - II. Analyses of nutritive components,”
`Bull. Tokai Reg. Fish. Res. Lab., 85, 13-30
`
`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)
`
`FDA, Agency Response Letter GRAS Notice No. GRN 000226,
`https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/No
`ticeInventory/ucm153881.htm, January 3, 2008
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`U.S. Patent No. 9,320,765
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`1050-
` 1052
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`1053
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`1054
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`1055
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`1056
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`1057
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`1058
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`1059
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`1060-
` 1068
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`1069
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`Reserved
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`File History to U.S. Patent No. 9,320,765 B2, Serial No, 14/020,155
`(‘765 File History)
`1053 Part 1 - Pages 1-500
`1053 Part 2 - Pages 501-998
`
`Notice of Commission Determination ending Investigation 337-TA-
`1019, dated May 23, 2017
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`Reserved
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`Respondents’ Motion for Leave to Amend Their Response to the
`Complaint and Notice of Investigation, United States International
`Trade Commission, Investigation No. 337-TA-1019 (ITC Amended
`Complaint),dated March 14, 2017
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`IDS filed March 17 2017 in file history for US Patent No. 9644169,
`Serial No. 15180431
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`IDS filed March 17 2017 in file history for US Patent No. 9644170,
`Serial No. 15180439
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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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`Krill Bill Bottle and Capsules from IRL
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`1070
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`1071
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`1072
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`1073-
` 1075
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`1076
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`1077
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`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).
`
`Antarctica Select Krill Oil Online Literature and Purchase Order
`Form and linked FDA webpage from 2006
`(https://web.archive.org/web/20060816050841/http://www.aquasour
`ceproducts.com:80/store/;
`https://web.archive.org/web/20060816051010/http://www.aquasour
`ceproducts.com:80/krill_oil.html;
`https://web.archive.org/web/20060506115548/
`http://www.aquasourceproducts.com:80/resources.html?osCsid=aee
`4bb3df08470be3a75bc598448dabc;
`https://web.archive.org/web/20060513152744/http://vm.cfsan.fda.go
`v/~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
`
`
`Affidavit of Christopher Butler, Office Manager of Internet Archive,
`dated November 8, 2017 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/it
`emdy00.asp?T1=KP1.
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`1078
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`Delaware District Court Stay pending resolution of IPRs, September
`6, 2017.
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`Inter Partes Review Case No.: IPR 2018-00295
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`I.
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`THE PETITION
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`U.S. Patent No. 9,320,765
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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 1-48 of U.S. Patent No. 9,320,765, entitled
`
`“Bioeffective Krill Oil Compositions,” issued April 26, 2016 (Serial No.
`
`14/020,155), filed September 6, 2013 (“the ‘765 patent”), assigned to Aker
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`Biomarine Antarctic AS (“Aker”). The ‘765 patent is submitted herewith as
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`Exhibit 1001. There is a reasonable likelihood that Petitioner will prevail with
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`respect to at least one claim challenged in this petition.
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`II. MANDATORY NOTICES
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`As set forth below and pursuant to 37 C.F.R. § 42.8(a)(1), the following
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`mandatory notices are provided as part of this petition.
`
`A. Real Parties-in-Interest
`
`Pursuant to 37 C.F.R. § 42.8(b)(1), Olympic Holding AS, Emerald Fisheries
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`AS, Rimfrost USA, LLC, Rimfrost New Zealand Limited, Bioriginal Food and
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`Science Corp., and Petitioner, Rimfrost AS, are identified as the real parties-in-
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`Inter Partes Review Case No.: IPR 2018-00295
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`interest. Several other entities have a majority ownership interest in the above-
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`U.S. Patent No. 9,320,765
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`identified real parties-in-interest. Based upon those ownership interests, and in an
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`abundance of caution, Petitioner also names Stig Remøy, SRR Invest AS, Rimfrost
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`Holding AS, and Omega Protein Corporation as real parties-in-interest.
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`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`Aker has asserted two patents – U.S. Patent Nos. 9,078,905 and 9,028,877 -
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`in a pending lawsuit brought by Aker Biomarine Antarctic AS against Olympic
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`Holding AS; Rimfrost AS; Emerald Fisheries AS, Rimfrost USA, LLC; Avoca
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`Inc.; and Bioriginal Food & Science Corp. Case No. 1:16-CV-00035-LPS-CJB (D.
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`Del.). (Complaint, Exhibit 1021). The litigation was stayed pursuant to 28 U.S.C.
`
`§ 1659 in view of Investigation No. 337-TA-1019 instituted by the United States
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`International Trade Commission on September 16, 2016 as noticed in the Federal
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`Register. The ITC proceeding, entitled In the Matter of Certain Krill Oil Products
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`and Krill Meal for Production of Krill Oil Products, related to U.S. Patent Nos.
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`9,028,877; 9,078,905; 9,072,752; 9,320,765; and 9,375,453. The ITC investigation
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`listed as respondents Olympic Holding AS, Rimfrost AS, Emerald Fisheries AS,
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`Avoca Inc., Rimfrost USA, LLC, Rimfrost New Zealand Limited and Bioriginal
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`Food & Science Corp. (Exhibit 1023). On May 23, 2017, pursuant to motions to
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`terminate, ITC Investigation No. 337-TA-1019 was effectively terminated.
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`U.S. Patent No. 9,320,765
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`(Exhibit 1054)1. In addition, a Stipulation of Dismissal as to Avoca Inc. was So
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`Ordered by the Delaware District Court on May 30, 2017. On January 27, 2017,
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`Petitioner filed IPR2017-0745 and IPR2017-0747 seeking inter partes review of
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`Claims 1-20 of U.S. Patent No. 9,078,905. On February 3, 2017, Petitioner filed
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`IPR2017-0746 and IPR2017-0748 seeking inter partes review of Claims 1-19 of
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`U.S. Patent No. 9,028,877. All of the IPRs were instituted on August 16, 2017. The
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`Delaware District Court action was stayed by the Court on September 6, 2017
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`pending resolution of the instituted IPRs. (Exhibit 1078).
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`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-
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`up lead counsel:
`
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`
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`1 Prior to termination of the ITC proceeding, the ALJ provided a Markman Order
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`construing certain terms of the `765 Patent (Exhibit 1059). See Tallon Decl. ¶¶ 55-
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`60.
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`3
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`Inter Partes Review Case No.: IPR 2018-00295
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`Lead Counsel:
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`Back-up Lead Counsel
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`U.S. Patent No. 9,320,765
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`Michael I. Chakansky
`Reg. No. 31,600
`Hoffmann & Baron, LLP
`micdocket@hbiplaw.com
`(973) 331-1700
`
`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
`
`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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`D.
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`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Service on Petitioner may be made electronically by using the following e-
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`mail address: 765ipr@hbiplaw.com and the e-mail addresses above. Service on
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`Petitioner may be made by Postal Mailing or Hand-Delivery addressed to Lead and
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`Back-up Lead Counsel at the following address, but electronic service above is
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`requested:
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`Inter Partes Review Case No.: IPR 2018-00295
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`U.S. Patent No. 9,320,765
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`Hoffmann & Baron, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
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`This document, together with all exhibits referenced herein, has been served
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`on the patent owner at its corporate headquarters, Oskenøyveien 10 No-1327, 1366
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`Lysaker, Norway, as well as the correspondence address of record for the ‘765
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`patent: Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton, Wisconsin
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`53562.
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`III. 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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`$41,800 (request fee of $9,000, post-institution fee of $14,000 and excess claims
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`fee of $18,800) for a Petition for Inter Partes Review is submitted herewith.
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`Claims 1-48 of the ‘765 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 the Petition.
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`Inter Partes Review Case No.: IPR 2018-00295
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`IV. ADDITIONAL REQUREMENTS FOR INTER PARTES REVIEW
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`U.S. Patent No. 9,320,765
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`A. Grounds for Standing (37 C.F.R. § 42.104(a))
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`Petitioner hereby certifies that the ‘765 patent is available for Inter Partes
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`Review and that Petitioner is not barred or estopped from requesting Inter Partes
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`Review challenging the claims of the ‘765 patent on the grounds identified herein.
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`B.
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`Level or Ordinary Skill in the Art
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`As of the earliest priority date the ‘765 patent is entitled to (i.e. no earlier
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`than January 28, 2008), a person of ordinary skill in the art (“POSITA”) would
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`have held an advanced degree in marine sciences, biochemistry, organic
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`(especially lipid) chemistry, chemical or process engineering, or associated
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`sciences with complementary understanding, either through education or
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`experience, of organic chemistry and in particular lipid chemistry, chemical or
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`process engineering, marine biology, nutrition, or associated sciences; and
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`knowledge of or experience in the field of extraction. In addition, a POSITA
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`would have had at least five years applied experience. (Declaration of Dr. Stephen
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`Tallon, Exhibit 1006, hereafter “Tallon Decl.” ¶ 29).
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`U.S. Patent No. 9,320,765
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`Inter Partes Review Case No.: IPR 2018-00295
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`C.
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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 1-48 are found
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`unpatentable and cancelled from the ‘765 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 1-48 of the ‘765 patent.
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`2.
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`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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`Ground
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`1
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`2
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`3
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`Reference(s)
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`Basis
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`Sampalis I, Catchpole,
`Fricke, and Breivik II
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`Sampalis I, Catchpole,
`Fricke, Breivik II, and
`Bottino I
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`Sampalis I, Catchpole,
`Fricke, Breivik II, 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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`35 U.S.C. § 103(a)
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`Claims
`Challenged
`1-4, 7, 9-11, 14,
`18-20, 25-28, 31,
`33-35, 38, 42-44,
`and 47
`5-6, 12-13, 15-16,
`21-23, 29-30, 36-
`37, 39-40, and 45-
`46
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`8, 17, 24, 32, 41,
`and 48
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`3.
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`Earliest Effective Priority Date
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`U.S. Patent No. 9,320,765
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`The ‘765 patent is a continuation of Application No. 12/057,775, filed on
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`March 28, 2008, now U.S. Patent No. 9,034,388. The ‘765 patent claims priority
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`to U.S. Provisional Application No. 60/920,483, filed on March 28, 2007, U.S.
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`Provisional Application No. 60/975,058, filed on September 25, 2007, U.S.
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`Provisional Application No. 60/983,446, filed on October 29, 2007, and U.S.
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`Provisional Application No. 61/024,072, filed on January 28, 2008. All of the
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`issued claims in the ‘765 patent require the element that the recited krill oil
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`comprise greater than about 3% w/w ether phospholipids. Support of the claim
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`element “ether phospholipid” – recited in each ‘765 claim – was not introduced
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`until the filing of U.S. Provisional Application No. 61/024,072 filed on January 28,
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`2008. (See Exhibits 1002-1005). In fact, there was no mention of ether
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`phospholipids at all until the January 28, 2008 Provisional. Consequently, the
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`earliest effective priority date for the claims of the ’765 patent is no earlier than
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`January 28, 2008. (Tallon Decl., ¶¶ 39-40).
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`In addition, the ‘765 Patent, at most, discloses that its invention includes
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`krill oil extracts with an ether phospholipid content of 7.4% by weight of krill oil.
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`(Exhibit 1001). However, as explained further below, all of the ‘765 Patent claims
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`require percentages of ether phospholipids with open-ended ranges of “greater
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`U.S. Patent No. 9,320,765
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`than” 3%, 4%, and 5% and no upper limit. None of the referenced priority
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`documents (Exhibits 1002, 1003, 1004, 1005, 1024, or 1047) contain any written
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`description of the complete range, or even a substantial portion of the range of
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`ether phospholipid percentages by w/w of krill oil claimed. Thus, lacking
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`sufficient written enabling disclosure, the ‘765 Patent is not entitled to a priority
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`date any earlier than filing of date of the application that issued as the ‘765 Patent,
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`namely September 6, 2013. (Tallon Decl., ¶¶ 41-49).
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`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 prior to 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 has an international filing date of April 20, 2007 and was published on
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`November 1, 2007 and, therefore, qualifies as a prior art reference under 35 U.S.C.
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`§ 102(e)2. Breivik II (Exhibit 1037) was filed as a PCT application, in English,
`
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`2 Catchpole and Breivik II are also prior art references under 35 U.S.C. § 102(a)
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`and, if the earliest effective filing date of the `765 patent is considered September
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`designating the US, on November 15, 2007 and claims priority to U.S. Provisional
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`U.S. Patent No. 9,320,765
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`Application No. 60/859,289 (Exhibit 1036) filed November 16, 2006 and therefore
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`qualifies as a reference under 102(e).
`
`§ 102(b) Reference
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`Publication Date
`
`Exhibit No.
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`Sampalis I
`
`Fricke
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`Bottino I
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`Randolph
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`May 2003
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`April 30, 1984
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`June 28, 1974
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`March 17, 2005
`
`1012
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`1010
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`1007
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`1011
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`§102(e) Reference
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`Effective Filing Date
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`Exhibit No.
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`Catchpole
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`Breivik II
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`April 20, 2007
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`November 16, 2006
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`1009
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`1037
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`6, 2013, they are also prior art under 35 U.S.C. § 102(b).
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`U.S. Patent No. 9,320,765
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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
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`patent according to the broadest reasonable construction in light of the
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`specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see Cuozzo
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`Speed Techs. v. Lee, LLC, 136 S. Ct. 2131, 2142–46 (2016). Under that standard,
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`and absent any special definitions, we give claim terms their ordinary and
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`customary meaning, as would be understood by one of ordinary skill in the art at
`
`the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth with
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`reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475,
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`1480 (Fed. Cir. 1994).
`
`V.
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`SUMMARY OF THE ‘765 PATENT (EXHIBIT 1001)
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`A. Background of the ‘765 Patent
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`The ‘765 patent relates to extracts from Antarctic krill that includes
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`bioactive fatty acids. (Exhibit 1001, p. 0025, col. 1, lines 19-20). In the Detailed
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`Description of the Invention, the patentees of the ‘765 patent state, “[t]his
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`invention discloses novel krill oil compositions characterized by containing high
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`levels of astaxanthin, phospholipids, included an enriched qualities of ether
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`U.S. Patent No. 9,320,765
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`phospholipids, and omega-3 fatty acids.” (Exhibit 1001, p. 0029, col. 9, lines 28-
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`31).
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`However, as acknowledged in the Background of the Invention, “a krill oil
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`composition has been disclosed comprising a phospholipid and/or a flavonoid.
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`The phospholipid content and the krill lipid extract could be as high as 60% w/w
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`and the EPA/DHA content as high as 35% (w/w). See, e.g., WO 03/011873.”
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`(Exhibit 1001, p. 0025, col. 1, lines 53-57). Patentees also acknowledged that krill
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`oil compositions have been described as being effective for decreasing cholesterol,
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`inhibiting platelet adhesion, inhibiting artery plaque formation, preventing
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`hypertension, controlling arthritis symptoms, preventing skin cancer, enhancing
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`transdermal transport, reducing the symptoms of premenstrual symptoms or
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`controlling blood glucose levels in a patient. Citing, e.g., WO 02/102394. (Exhibit
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`1001, p. 0025 col. 1, lines 46-52). Patentees also assert, “[s]upercritical fluid
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`extraction with solvent modifier has previously been used to extract marine
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`phospholipids from salmon roe, but has not been previously used to extract
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`phospholipids from krill meal. See, e.g., Tanaka et al., J. Oleo. Sci. (2004), 53(9),
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`417-424.” (Exhibit 1001, p. 0025, col. 1, line 65 to col. 2, line 2). This statement
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`U.S. Patent No. 9,320,765
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`is demonstrably false. (See, e.g., Catchpole, Exhibit 1009).
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`As further described below, the prior art and knowledge known to the
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`POSITA demonstrate that the lipid components described in these claims of the
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`‘765 Patent are the lipid components naturally found in the Euphausia superba
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`krill oil that can be extracted using any of a number of suitable solvents. (Tallon
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`Decl. ¶ 286).
`
`B.
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`Prosecution History of the ‘765 Patent
`
`The ‘765 patent issued on April 26, 2016 from U.S. Application No.
`
`14/020,155 filed on September 6, 2013. The ‘765 patent is a continuation of U.S.
`
`Patent Application No. 12/057,775 filed on March 28, 2008 and claims the benefit
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`of four U.S. Provisional Applications: 61/024,072 filed on January 28, 2008;
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`60/983,446 filed on October 29, 2007; 60/975,058 filed on September 25, 2007;
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`and 60/920,483 filed on March 28, 2007.
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`On June 18, 2015, the Examiner issued a non-final Office Action rejecting
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`all of the pending claims, i.e., claims 1-12. The claims were rejected under 35
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`U.S.C. § 112, second paragraph, as being indefinite for failing to point and
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`distinctly claim the subject matter which the inventor regards as the invention. In
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`addition, the Examiner rejected the pending claims under 35 U.S.C. § 102(b) as
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`U.S. Patent No. 9,320,765
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`anticipated by or, in the alternative, under § 103(a) as obvious over Sampalis
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`(US2004/0241249). (Exhibit 1053, part 1, pp. 0273 to 0280). The Examiner
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`asserted, “[c]laims are drawn to krill oil having greater than about 40%
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`phosphatidylcholine from Euphausia superba. Also krill oil may comprise
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`triglycerides and omega fatty acids and astaxanthin. Further, krill oil can be in
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`capsule form and orally administered to a subject for method of treating the
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`subject. All in varied w/w % amounts.” (Exhibit 1053, part 1, p. 0278).
`
`In response, on October 8, 2015, Claim 1 was amended to delete the “greater
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`than about 40% phosphatidylcholine” element, and include the ether phospholipid,
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`non-ether phospholipid, triglyceride, and astaxanthin esters elements as set forth in
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`issued claim 1. Claims 2-12 were cancelled. New claims 13-59 were added.
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`(Exhibit 1053, part 1, pp. 0089 to 0097).
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`In the Remarks section of the Amendment, Applicants argued that it was
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`believed that ether phospholipids would not provide health benefits and therefore a
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`POSITA would not have sought to increase the ether phospholipid level to that set
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`forth in the claims. Applicants also point to the Example 9 in the specification
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`allegedly demonstrating unexpected results with krill oil compositions greater than
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`3% ether phospholipids over prior art krill oils with lower ether phospholipid
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`U.S. Patent No. 9,320,765
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`levels. (Exhibit 1053, part 1, pp. 0096 to 0097).
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`A Notice of Allowance was mailed on December 24, 2015. The Issue Fee
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`was paid on March 17, 2016. (Exhibit 1053, part 1, pp. 0009 to 0015). As
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`indicated above, the patent then iss
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