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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.: IPR2018-01730
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`U.S. Patent 9,072,752
`
`Issue Date: July 7, 2015
`
`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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`A.
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`B.
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`C.
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`D.
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`PAYMENT OF FEES ..................................................................................... 6
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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)) ................................... 4
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`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 5
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`TABLE OF CONTENTS
`
`I.
`
`THE PETITION ............................................................................................... 1
`
`II. MANDATORY NOTICES ............................................................................. 1
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`Real Parties-in-Interest .......................................................................... 1
`
`III.
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`IV. ADDITIONAL REQUIREMENTS 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
`
`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
`
`2.
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`3.
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`i
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`4.
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`Prior Art References.................................................................... 9
`
`D.
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`Claim Construction-Broadest Reasonable Interpretation
`(“BRI”) (37 C.F.R. § 42.104(b)(3)) ....................................................13
`
`SUMMARY OF THE ‘752 PATENT (EXHIBIT 1001) ..............................14
`
`V.
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`A.
`
`B.
`
`C.
`
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`Background of the ‘752 Patent ............................................................14
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`Prosecution History of the ‘752 Patent ...............................................16
`
`Construction of the ‘752 Patent Claim Terms.....................................17
`
`1.
`
`2.
`
`3.
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`Claims 1-13 - “polar krill oil” ...................................................17
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`Claims 7, 14 - “astaxanthin” .....................................................19
`
`Claims 8-10, 17-19 - “astaxanthin ester” ..................................21
`
`4.
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`5.
`
`Claims 1, 14 - “greater than about 5% ether
`phospholipids” ..........................................................................22
`
`Claim 1- “greater than about 40% ether
`phosphatidylcholine” ................................................................27
`
`VI. EACH GROUND PROVIDES MORE THAN A REASONABLE
`LIKELIHOOD THAT EACH CLAIM OF THE ‘752 PATENT IS
`UNPATENTABLE ........................................................................................27
`
`A. Ground 1: Section 102(e) - Catchpole
`[Claims 1, 5-6, 11] ...............................................................................28
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`B.
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`C.
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`E.
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`F.
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`Ground 2: Section 103(a) - Catchpole and Sampalis II
`[Claims 4, 7, 12-13] .............................................................................35
`
`Ground 3: Section 103(a) - Catchpole Grynbaum and Randolph
`[Claims 8-10] .......................................................................................43
`
`D. Ground 4: Section 103(a) - Catchpole and Enzymotec
`[Claims 1-3, 5-6, 11] ...........................................................................49
`
`Ground 5: Section 103(a) - Catchpole, Enzymotec and Sampalis II
`[Claims 14-16, 20] ...............................................................................59
`
`Ground 6: Section 103(a) - Catchpole, Enzymotec, Sampalis II
`Grynbaum and Randolph [Claims 17-19] ...........................................64
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`Claim Chart .........................................................................................69
`
`G.
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`VII. CONCLUSION ..............................................................................................87
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`VIII. CERTIFICATE OF COMPLIANCE ............................................................88
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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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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`1010
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`APPENDIX OF EXHIBITS
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`EXHIBIT DESCRIPTION
`
`U.S. Patent No. 9,072,752 B1, filed February 12, 2015 (‘752)
`
`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)
`
`Fricke et al., “Lipid, Sterol and Fatty Acid Composition of
`Antarctic Krill (Euphausia superba Dana),” LIPIDS
`19(11):821-827 (1984) (Fricke)
`
`iv
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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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
`
`
`1017
`
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`1020
`
`
`
`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).
`
`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).
`
`v
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`1021
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`1023
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`1024
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`
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`1030
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`1031
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`1032
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`
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`1033
`
`Complaint 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 5A - Pages 1801-2025
`1024 Part 5B - Pages 2026-2250
`1024 Part 6 - Pages 2251-2700
`1024 Part 7 - Pages 2701-3083
`1024 Part 8 - Pages 3084-3223
`
`
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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).
`vi
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`1035
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`1036
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`1037
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`1038
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`1039
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`1040
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`1043
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`1044
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`1045
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`1047
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`
`Breivik, U.S. Patent Application Publication No. US
`2010/0143571 A1, “Process for Production of Omega-3 Rich
`Marine Phospholipids from Krill” (Breivik I).
`
`Breivik, U.S. Provisional Patent Application No. 60/859,289,
`“Processes for production of omega-3 rich marine
`phospholipids from krill”, filed November 16, 2006 (Breivik
`‘289 Provisional, Breivik III)
`
`Breivik, WO 2008/060163 A1, “Process for Production of
`Omega-3 Rich Marine Phospholipids from Krill,” International
`filing date November 15, 2007 (Breivik II).
`
`Bottino, N.R., “Lipid Composition of Two Species of Antarctic
`Krill: Euphausia Superba and E. Crystallorophias”, Comp.
`Biochem. Physiol., 1975, Vol. 50B, pp. 479 to 484 (Bottino II).
`
`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).
`
`File History to U.S. Patent No. 9,072,752 B1, Serial No,
`14/620,784 (‘752 File History).
`
`Bruheim, U.S. Patent Application Publication No.
`US2008/0274203 A1, published November 6, 2008 (this is the
`publication of patent application serial no. 12/057,775 which
`issued as U.S. Patent No. of 9,034,388).
`
`Declaration of Robert S. McQuate.
`
`Declaration of Rakesh Kapoor.
`
`U.S. Patent No. 9,034,388 B2, filed May 28, 2008 (‘388 Patent)
`
`vii
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`Inter Partes Review Case No.: IPR2018-01730
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`U.S. Patent No. 9,072,752
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`1048
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`1049
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`1050
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`1051
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`1052
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`1054
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`1059
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`
`
`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/GRA
`S/NoticeInventory/ucm153881.htm, January 3, 2008.
`
`Gaynor, P, “How U.S. FDA's GRAS Notification Program
`Works”, Reprinted with permission of the publishers from Food
`Safety Magazine December 2005/January 2006.
`http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS
`/ucm083022.htm
`
`Federal Register, Vol. 62, No. 74, pp. 18938-18964, April 17,
`1997.
`
`FDA GRAS Notices, August 05, 2007, listing GRN 226 on
`Internet, “Krill-derived lecithin,” Wayback Machine,
`https://web.archive.org/web/20070805011458/http://www.cfsan
`.fda.gov:80/~rdb/opa-gras.html.
`
`Notice of Commission Determination ending Investigation 337-
`TA-1019, dated May 23, 2017.
`
`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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`U.S. Patent No. 9,072,752
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`1060
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`1061
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`1062
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`1063
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`1067
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`1069
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`1070
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`
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`Enzymotec website pages (September 25, 2007)
`(https://web.archive.org/web/20070925024350/http://www.enz
`ymotec.com/PageIndex.asp?cc=01020403)
`(https://web.archive.org/web/20070925024521/http://www.enz
`ymotec.com/Page.asp?cc=01020408)
`
`Affidavit of Christopher Butler, Office Manager of Internet
`Archive dated August 22, 2017 regarding FDA GRAS Notices
`and Enzymotec related webpages.
`
`FDA, Freedom of Information Annual Report 2007,
`https://www.fda.gov/RegulatoryInformation/FOI/FOIAAnnual
`Reports/ucm148025.htm.
`
`File History to U.S. Patent No. 9,644,170 B2, Serial No,
`15/180,439 (‘170 File History)
`1063 Part 1 - Pages 1-400
`1063 Part 2 - Pages 401-800
`1063 Part 3 – Pages 801-1107
`
`U.S. Patent No. 9,375,453 B2, filed September 6, 2013 (‘453).
`
`Krill Bill Bottle and Capsules from IRL
`
`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.krillb
`ill.com/profile.htm).
`
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`1071
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`1072
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`1075
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`1076
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`1077
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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.f
`da.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.
`
`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.
`
`Pure Encapsulations online literature for its Krill-plex NKO™
`product, webpage from August 19, 2004.
`https://web.archive.org/web/20040819183137/www.purecaps.c
`om/itemdy00.asp?T1=KP1.
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`x
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`1078
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`1080
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`1084
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`1089
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`1091
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`1092
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`1093
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`1094
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`1095
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`Del. District Court Stay of 16-cv-00035, pending resolution of
`IPRs, Order dated September 6, 2017.
`
`Hoem, N., “Composition of Antarctic krill oil and methods for
`its harvesting, production and qualitative and quantitative
`analysis”, Aker BioMarine, Newcastle Australia November
`2013 (Hoem).
`
`Mayzaud et al, “Changes in lipid composition of the Antarctic
`krill Euphausia superba 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)
`
`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
`
`Neptune GRAS Agency Response Letter GRN 000242.
`
`Affidavit of Christopher Butler, Office Manager of Internet
`Archive, dated February 5, 2018, regarding Rimfrost
`Exhibit 1077, Pure Encapsulations online literature for its Krill-
`plex NKO™ product, webpage from August 19, 2004.
`
`U.S. Patent No. 9,644,170 B2, filed June 13, 2016 (‘170).
`
`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.
`xi
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`1097
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`1098
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`1099
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`1100
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`1101
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`1102
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`1103
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`1104
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`1105
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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).
`
`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.
`
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`Occurrence in some Marine Products, J. Sci. of Food and
`Agriculture, 1971, Vol. 22, February.
`
`Foss, et al., Natural occurrence of enantiomeric and Meso
`
`astaxanthin 7∗-crustaceans including zooplankton,
`
`Comparative Biochemistry and Physiology Part B:
`Comparative Biochemistry, Volume 86, Issue 2, 1987, Pages
`313-314.
`
`Final Written Decision, IPR2017-00745, August 10, 2018,
`Paper 24 (U.S. Patent No. 9,078,905).
`
`Final Written Decision, IPR2017-00746, August 10, 2018,
`Paper 23 (U.S. Patent No. 9,028,877).
`
`Patent Owner’s Motion to Amend the Claims, Paper 16 in
`IPR2018-00295 (U.S. Patent No. 9,320,765).
`
`xii
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`Declaration of Dr. Nils Hoem in Support of Patent Owner’s
`Motion to Amend, Exhibit 2013 in IPR2018-00295 (U.S. Patent
`No. 9,320,765).
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`Inter Partes Review Case No.: IPR2018-01730
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`
`I.
`
`THE PETITION
`
`U.S. Patent No. 9,072,752
`
`Petitioner, real party-in-interest, Rimfrost AS, a Norwegian corporation,
`
`with its principal place of business at Vågsplassen, 6090, Fosnavåg, Norway,
`
`hereby petitions the Patent Trial and Appeal Board (the “Board” or the “PTAB”) of
`
`the United States Patent and Trademark Office (“PTO”), pursuant to 35 U.S.C. §§
`
`311-319 and 37 C.F.R. § 42.1 et seq., to institute an inter partes review and to find
`
`unpatentable and cancel claims 1-20 of U.S. Patent No. 9,072,752 entitled
`
`“Bioeffective Krill Oil Compositions” (the ‘572 patent”). The ‘752 patent issued
`
`on July 7, 2015, was filed February 12, 2015 (U.S.S.N. 14/620,784), and was
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`assigned to Aker Biomarine Antarctic AS (“Aker”). The ‘752 patent is submitted
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`as 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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`A. Real Parties-in-Interest
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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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`upon those ownership interests, and in an abundance of caution, Petitioner also
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`Inter Partes Review Case No.: IPR2018-01730
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`names Stig Remøy, SRR Invest AS, Rimfrost Holding AS, and Omega Protein
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`U.S. Patent No. 9,072,752
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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 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 proceeding 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, the ITC proceeding was terminated. (Exhibit 1054). In addition,
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`the Delaware District Court granted a Stipulation of Dismissal as to Avoca Inc. on
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`May 30, 2017.
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`U.S. Patent No. 9,072,752
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`Inter Partes Review Case No.: IPR2018-01730
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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 (“the
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`‘905 patent”). On February 3, 2017, Petitioner filed petitions in IPR2017-0746 and
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`IPR2017-0748 requesting review of claims 1-19 of U.S. Patent No. 9,028,877 (“the
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`‘877 patent”). Each of these IPRs was instituted on August 16, 2017. On
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`September 6, 2017, the Delaware District Court action was stayed pending
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`resolution of the IPRs. (Exhibit 1078). On August 24, 2018, based primarily upon
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`the disclosure and teachings of Catchpole (Exhibit 1009), the Board ruled that
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`claims 1-20 of the ‘905 patent and claims 1-19 of the ‘877 patent are unpatentable.
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`Exhibit 1103 (IPR2017-00745, Paper No. 24); Exhibit 1104 (IPR2017-00746,
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`Paper 23).1
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`1 In separate IPRs that did not rely upon Catchpole, the Board determined that
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`Petitioner failed to demonstrate by a preponderance of evidence that the challenged
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`claims of the ‘905 and ‘877 patents were unpatentable. IPR2017-00747, Paper No.
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`24; IPR2017-00748, Paper 23.
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`U.S. Patent No. 9,072,752
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`Inter Partes Review Case No.: IPR2018-01730
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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 ‘170 patent”). On
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`August 29, 2018, the Board determined that the ‘170 patent was not eligible for
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`post grant review.
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`On June 26, 2018, Petitioner filed petitions in IPR2018-01178 and IPR2018-
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`01179 requesting review of claims 1-31 and claims 32-61 of U.S. Patent No.
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`9,375,453, respectively. The Board has not yet issued an Institution Decision for
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`either of these reviews.
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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 Lead 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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`Michael I. Chakansky
`Reg. No. 31,600
`Hoffmann & Baron, LLP
`micdocket@hbiplaw.com
`(973) 331-1700
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`U.S. Patent No. 9,072,752
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`Additional Back-up Lead Counsel
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`John T. Gallagher
`Reg. No. 35,516
`Hoffmann & Baron, LLP
`jtgdocket@hbiplaw.com
`(516) 822-3550
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`Ronald J. Baron
`Reg. No. 29,281
`Hoffmann & Baron, LLP
`rjbdocket@hbiplaw.com
`(516) 822-3550
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`Service Information (37 C.F.R. § 42.8(b)(4))
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`D.
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`Service on Petitioner may be made electronically by using the following e-
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`mail address: 752ipr@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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`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 ‘752 patent:
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`U.S. Patent No. 9,072,752
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`Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton, Wisconsin 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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`$33,500 (request fee of $15,500, post-institution fee of $15,000, and excess post-
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`institution clams fee of $3,000) for a Petition for Inter Partes Review is submitted
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`herewith. Claims 1-20 of the ‘752 patent are being reviewed as part of this Petition.
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`The 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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`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW
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`A. Grounds for Standing (37 C.F.R. § 42.104(a))
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`Petitioner certifies that the ‘752 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 the claims of the ‘752 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 ‘752 patent’s earliest priority date, a person of ordinary skill in the
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`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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`Inter Partes Review Case No.: IPR2018-01730
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`engineering, or associated sciences with complementary understanding, either
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`U.S. Patent No. 9,072,752
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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)”, ¶¶ 33-34).
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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 1-20 are found
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`unpatentable and cancelled from the ‘752 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 1-20 of the ‘752 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 six (6) 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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`Reference(s)
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`Basis
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`Catchpole
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`35 U.S.C. § 102(e)
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`Catchpole and
`Sampalis II
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`35 U.S.C. § 103(a)
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`Claims
`Challenged
`1, 5-6, 11
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`4, 7, 12-13
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`7
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`U.S. Patent No. 9,072,752
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`Catchpole, Grynbaum
`and Randolph
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`Catchpole and
`Enzymotec
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`Catchpole, Enzymotec
`and Sampalis II
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`Catchpole Enzymotec,
`Sampalis II, Grynbaum
`and Randolph
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`35 U.S.C. § 103(a)
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`8-10
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`35 U.S.C. § 103(a)
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`1-3, 5-6, 11
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`35 U.S.C. § 103(a)
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`14-16, 20
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`35 U.S.C. § 103(a)
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`17-19
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`Inter Partes Review Case No.: IPR2018-01730
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`3
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`4
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`5
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`6
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`3.
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`Earliest Effective Priority Date
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`The ‘752 patent is a continuation of U.S.S.N. 12/057,775, filed on March 28,
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`2008, now U.S. Patent No. 9,034,388. The ‘752 patent claims priority to the
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`following U.S. Provisional Applications: 60/920,483, filed March 28, 2007;
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`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 ‘752 patent
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`require that the recited krill oil comprise “greater than about” 5% w/w ether
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`phospholipids. However, support for the claim element “ether phospholipid” -
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`recited in each ‘752 patent claim - was not introduced until the filing of U.S.
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`Provisional Application 61/024,072 on January 28, 2008. (See Exhibits 1002-
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`1005). In fact, there was no mention of ether phospholipids at all until the January
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`28, 2008 Provisional. Consequently, the effective priority date for the ‘752 patent
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`U.S. Patent No. 9,072,752
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`is no earlier than January 28, 2008. (Tallon (Exhibit 1006), ¶¶ 74-75).
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`Alternatively, there is no Section 112(a) support for unbounded ranges
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`required by the challenged claims. Thus, the effective priority date is no earlier
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`than February 15, 2015. (Tallon (Exhibit 1006), ¶¶ 5, 50-73).
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`Prior Art References
`4.
`Other than Catchpole (Exhibit 1009) and Enzymotec (Exhibit 1048), all
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`references relied upon were published more than one year prior to the earliest
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`possible priority date of January 28, 2008, and therefore are prior art under 35
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`U.S.C.§ 102(b). Catchpole 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
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`U.S.C. § 102(e).2
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`Enzymotec (Exhibit 1048) is a May 26, 2007 Notice submitted to the Food
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`and Drug Administration (“FDA”) requesting a GRAS (“Generally Recognized As
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`Safe”) exemption for the use of a krill-based lecithin extract. (McQuate (Exhibit
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`1044), ¶¶32-34). Substantial evidence demonstrates that Enzymotec was publicly
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`2 Catchpole is also prior art under 35 U.S.C. § 102(a).
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`9
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`Inter Partes Review Case No.: IPR2018-01730
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`accessible to persons of ordinary skill exercising reasonable diligence before the
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`U.S. Patent No. 9,072,752
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`‘752 patent’s critical date of January 28, 2008, and therefore qualifies as prior art
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`under Section 102(a). See Carella v. Starlight Archery, 804 F.2d 135, 139 (Fed.
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`Cir. 1986) (Section 102(a) “language ‘known or used by others’ means knowledge
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`and use which is accessible to the public”).
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`Individuals interested and ordinarily skilled in krill-based extracts, would
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`have been familiar with FDA GRAS Notices (e.g., McQuate (Exhibit 1044), ¶¶ 5-
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`7, 39, 45; e.g., Kapoor (Exhibit 1045), ¶¶ 9-10), would have known that GRAS
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`Notices were indexed and searchable by substance on the FDA website (e.g.,
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`McQuate (Exhibit 1044), ¶¶ 6, 9, 27), and would have been motivated to look for
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`GRAS Notices related to krill and krill-based extracts. (e.g., Kapoor (Exhibit
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`1045), ¶12; McQuate (Exhibit 1044), ¶ 45). See, e.g., Jazz Pharms., Inc. v. Amneal
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`Pharms., Inc., 895 F.3d 1347, 1355 (Fed. Cir. 2018) (citation omitted) (“A
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`reference is considered publicly accessible ‘upon a satisfactory showing that such
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`document has been disseminated or otherwise made available to the extent that
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`persons interested and ordinarily skilled in the subject matter or art, exercising
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`reasonable diligence, can locate it.’”).
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`U.S. Patent No. 9,072,752
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`Upon filing with the FDA, Enzymotec was indexed by both GRN number
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`(“GRN 226”) and active ingredient (“krill-derived lecithin”) on the FDA’s on-line
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`searchable directory, entitled “Summary of All GRAS Notices.” (McQuate
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`(Exhibit 1044), ¶¶ 26-27, 32-34). As a result, once filed, Enzymotec became
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`publicly accessible to all individuals interested in krill-based extracts by simply
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`submitting a FOIA request. (21 CFR 170.36). (McQuate (Exhibit 1044), ¶¶ 5, 8-
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`10, 28, 30-31, 36-38, 44-46). In fact, the GRAS Notice directory states:
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`Persons interested in obtaining additional data and
`information in the notice may obtain a copy of those data
`and information that are disclosable by requesting the
`information under the Freedom of Information Act (see
`FDA’s document entitled “How to Request Information
`or Make a Freedom of Information Request”).
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`(McQuate (Exhibit 1044), ¶ 28); See, e.g., GoPro, Inc. v. Contour IP Holding LLC,
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`898 F.3d 1170, 1174 (Fed. Cir. 2018) (Section 102 is interpreted “broadly” so that
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`documents qualify “as prior art so long as the rel
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