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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`RIMFROST AS
`
`Petitioner
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
`
`
`
`
`
`Case No.: PGR2018-00033
`
`U.S. Patent 9,644,170
`
`Issue Date: May 9, 2017
`
`Title: Bioeffective Krill Oil Compositions
`
`
`
`
`
`
`
`PETITION FOR POST GRANT REVIEW
`
`UNDER 35 U.S.C. §§ 321-329 AND 37 C.F.R. § 42.200 ET SEQ.
`
`
`
`AKER EXHIBIT 2013 Page 1
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`
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`
`
`TABLE OF CONTENTS
`
`
`
`THE PETITION ................................................................................................. 1
`
` MANDATORY NOTICES ................................................................................ 1
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Parties-In-Interest .......................................................................... 1
`
`Related Matters (37 C.F.R. § 42.8(b)(2)) .............................................. 2
`
`Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a)) ................................... 3
`
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 4
`
` PAYMENT OF FEES ........................................................................................ 5
`
` ADDITIONAL REQUIREMENTS FOR POST-GRANT REVIEW ............... 5
`
`A. Grounds For Standing (37 C.F.R. § 42.204(a)) .................................... 5
`
`B.
`
`C.
`
`Level Of Ordinary Skill In The Art ....................................................... 6
`
`Identification Of Challenge And Relief Requested
`(37 C.F.R. § 42.204(b) and 37 C.F.R. § 42.22(a)(1)) ........................... 6
`Claims for which Post-Grant Review is Requested
`1.
`(37 C.F.R. § 42.204(b)(2)) .......................................................... 6
`Specific Statutory Grounds on which the Challenge is Based
`(37 C.F.R. § 42.204(b)(2)) .......................................................... 7
`Earliest Effective Priority Date ................................................... 7
`
`3.
`
`2.
`
`AKER EXHIBIT 2013 Page 2
`
`
`
`D.
`
`Prior Art References.................................................................... 8
`4.
`Claim Construction-Broadest Reasonable Interpretation (“BRI”)
`(37 C.F.R. § 42.204(B)(3)) .................................................................... 9
` SUMMARY OF THE ‘170 PATENT (EXHIBIT 1001) ................................10
`
`A.
`
`B.
`
`C.
`
`Background Of The ‘170 Patent..........................................................10
`
`Prosecution History Of The ‘170 Patent .............................................12
`
`Construction of the ‘170 Patent Claim Terms.....................................14
`
`1.
`
`2.
`
`3.
`
`Claims 1-20 - “krill oil” ............................................................15
`
`Claims 6 and 17 - “phytonutrient” ............................................16
`
`Claims 1, 3, 11, and 13 – “astaxanthin esters” .........................17
`
` EFFECTIVE FILING DATE, FITF AND PGR. .............................................19
`
`A.
`
`The ‘170 Patent Family Chart .............................................................19
`
`B.
`
`C.
`
`“Transition Patents” Which Fail To Comply With Section 112(a)
` Are PGR Eligible................................................................................21
`Section 112(a)’s Requirements. ..........................................................24
`1.
`Possession of the Invention. ......................................................24
`
`2.
`
`Enablement of the Invention. ....................................................24
`
`AKER EXHIBIT 2013 Page 3
`
`
`
`E.
`
`2.
`
`3.
`
`D.
`
`Failure To find Section 112(a) Support In The ‘170 Patent
`Specification Is The Same As Finding Lack Of Section 112(a)
`Support For Its Parent (The ‘453 Patent) And Its Grandparent
`(The ‘388 Patent). ................................................................................27
`The ‘170 Patent Is Eligible For Post Grant Review ............................28
`1.
`There is no Section 112(a) support for ether phospholipids in
`the upper portion of the recited range of 3% to 15% w/w
`krill oil i.e., 8% to 15%, as required at least by ‘170 patent
`claims 1 and 11. ........................................................................31
`There is no Section 112(a) support for astaxanthin esters
`for most of the claim limitation of astaxanthin esters in
`amount of about 100 mg/kg of said krill oil to at least
`85% w/w of krill oil as required by at least ‘170 patent
`claims 1 and 11. ........................................................................36
`There is no Section 112(a) support for ‘170 patent
`application’s original claim 1’s “trimethylamine in an
`amount of less than 1 mg/kg of said krill oil”...........................40
` THE ‘388 PATENT PUBLICATION (EXHIBIT 1043) BRUHEIM I,
`PUBLISHED NOVEMBER 6, 2008, QUALIFIES AS PRIOR ART UNDER
`AIA 35 U.S.C. § 102(A)(1) .............................................................................44
` IT IS MORE LIKELY THAN NOT THAT EACH CLAIM OF THE
`‘170 PATENT IS UNPATENTABLE .............................................................45
`A. Ground 1: Section 112(A) Unpatentable Under For Lack Of
`Possession And Enablement................................................................46
`1.
`No possession or enablement of entire ether phospholipid
`ranges. .......................................................................................46
`No possession or enablement of entire astaxanthin esters
`ranges. .......................................................................................46
`Ground 2: Section 101 – Non-Patentable Subject Matter
`[Claims 1-20] .......................................................................................47
`
`2.
`
`B.
`
`AKER EXHIBIT 2013 Page 4
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`
`
`C.
`
`Ground 3: Section 101 – Lack Of Inventorship [Claims 1-20] ..........56
`
`F.
`
`E.
`
`D. Ground 4: Section 102(a) – Bruheim I (Exhibit 1043)
`[Claims 1-20] .......................................................................................62
`Ground 5: Section 103(a) – Bruheim II And Neptune’s GRAS
`[Claims 1, 3-5, 7, 9-11, 13-16, 18 And 20] .........................................69
`Ground 6: Section 103(a) – Neptune’s GRAS, Bruheim II And
`Sampalis III [Claims 2 And 12] ..........................................................81
`G. Ground 7: Section 103(a) – Neptune’s GRAS, Bruheim II And
`Randolph [Claims 6 And 17] ..............................................................82
`H. Ground 8: Section 103(a) – Neptune’s GRAS, Bruheim II And
`Bottino I [Claims 8 And 19] ................................................................86
` CLAIM CHART ..............................................................................................90
`
` CONCLUSION ..............................................................................................118
`
` CERTIFICATE OF COMPLIANCE .............................................................119
`
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`AKER EXHIBIT 2013 Page 5
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`Affinity Labs of Texas v. DIRECTV, LLC,
`838 F.3d 1253 (Fed. Cir. 2016) ............................................................................49
`AK Steel Corp. v. Sollac & Ugine,
`344 F.3d 1234 (Fed. Cir. 2003) .................................................................... 26, 63
`Alice Corp Pty. Ltd. v. CLS Bank Int’l,
`134 S. Ct. 2347 (2014) .........................................................................................49
`Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,
`569 U.S. 576 (2013) .................................................................... 48, 49, 52, 54, 55
`Chiron Corp. v. Genentech, Inc.,
`363 F.3d 1247 (Fed. Cir. 2004) ...........................................................................25
`Cleveland Clinic Found. v. True Health Diagnostics,
`859 F.3d 1352 (Fed. Cir. 2017) ...........................................................................53
`Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat’l Ass’n,
`776 F.3d 1343 (Fed. Cir. 2014) .................................................................... 50, 56
`Cubist Pharms., Inc. v. Hospira, Inc.,
`75 F. Supp. 3d 641 (D. Del. 2014) .......................................................................57
`Cuozzo Speed Techs. v. Lee, LLC,
`136 S. Ct. 2131 (2016) .........................................................................................10
`Diamond v. Chakrabarty,
`447 U.S. 303 (1980) ...................................................................................... 48, 55
`Funk Brothers Seed Co. v. Kalo Inoculant Co.,
`333 U.S. 127 (1948) ...................................................................................... 48, 55
`
`AKER EXHIBIT 2013 Page 6
`
`
`
`In re Comiskey,
`554 F.3d 967 (Fed. Cir. 2009)..............................................................................56
`In re Fisher,
`427 F.2d 833 (CCPA 1970) .................................................................................25
`In re Lukach,
`442 F.2d 967 (CCPA 1971) .................................................................................44
`In re Paulsen,
`30 F.3d 1475 (Fed. Cir. 1994)..............................................................................10
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) ...........................................................................10
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988)..............................................................................25
`Intellectual Ventures, I LLC v. Symantec Corp.,
`838 F.3d 1307 (Fed. Cir. 2017) ...........................................................................55
`Lockwood v. Am. Airlines, Inc.,
`107 F.3d 1565 (Fed. Cir. 1997) ...........................................................................24
`Madstad Engineering, Inc. el al. v. U.S. Patent & Trademark Office et al.,
`8:12-cv-01589, (M.D. Fla. Sept. 18, 2012)..........................................................58
`MagSil Corp. v. Hitachi Global Storage Techs., Inc.,
`687 F.3d 1377 (Fed. Cir. 2012) ...........................................................................26
`Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
`556 U.S. 66 (2012) ........................................................................................ 49, 55
`Noelle v. Lederman,
`355 F.3d 1343 (Fed. Cir. 2004) ...........................................................................24
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ...........................................................................26
`
`AKER EXHIBIT 2013 Page 7
`
`
`
`Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc.,
`827 F.3d 1042 (Fed. Cir. 2016) ...........................................................................48
`Sitrick v. Dreamworks, LLC,
` 516 F.3d 993 (Fed. Cir. 2008) ............................................................................25
`Tronzo v. Biomet Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ...........................................................................24
`Vas-Cath Inc. v. Sakharam D. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) ............................................................................24
`PTAB Decisions
`Arkema Inc. v. Honeywell International Inc.,
`PGR2016-00012, FWD (PTAB Aug. 31, 2017) ..................................................23
`Inguran, LLC v. Premium Genetics (UK) Ltd.,
`PGR2015-00017, DTI (PTAB Dec. 22, 2015) ....................................................23
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`PGR2015-00019, FWD, (PTAB, Dec. 18, 2016) ......................................... 28, 45
`Statutes
`
`28 U.S.C. § 1659 ........................................................................................................ 2
`
`35 U.S.C. § 100(i) ............................................................................................. 22, 23
`
`35 U.S.C. § 101 ..................................................................... 7, 48, 49, 56, 57, 58, 62
`
`35 U.S.C. § 102 ........................................................................................................23
`
`35 U.S.C. § 102(a) ........................................................................................ 7, 44, 62
`
`35 U.S.C. § 102(b) ..................................................................................................... 8
`
`35 U.S.C. § 102(f) ....................................................................................................57
`
`AKER EXHIBIT 2013 Page 8
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`
`
`35 U.S.C. § 103 ........................................................................................................23
`
`35 U.S.C. § 103(a) ...................................................................... 7, 69, 81, 82, 86, 89
`
`35 U.S.C. § 112(a) ........................................................................................... passim
`
`35 U.S.C. § 115(a) ............................................................................................ 58, 62
`
`35 U.S.C. § 120 ........................................................................................................24
`
`35 U.S.C. § 321(c) ...................................................................................................21
`
`35 U.S.C. § 324(a) ..................................................................................................... 1
`
`35 U.S.C. § 102 ........................................................................................................23
`
`35 U.S.C. § 103 ........................................................................................................23
`
`Manual of Patent Examining Procedure
`
`MPEP § 2157 ...........................................................................................................58
`
`MPEP § 2159.02 ......................................................................................................23
`
`
`
`
`
`
`
`
`
`
`
`AKER EXHIBIT 2013 Page 9
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`
`
`
`APPENDIX OF EXHIBITS
`
`
`EXHIBIT DESCRIPTION
`
`
`
`EXHIBIT NO.
`
`
`
`1001
`
`
`
`U.S. Patent No. 9,644,170 B2, filed June 13, 2016 (‘170)
`
`1002
`
`
`1003
`
`
`1004
`
`
`1005
`
`
`1006
`
`1007
`
`
`1008
`
`1009
`
`
`1010
`
`
`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)
`
`RESERVED
`
`Catchpole and Tallon, WO 2007/123424, published November
`1, 2007, “Process for Separating Lipid Materials,” (Catchpole)
`
`RESERVED
`
`AKER EXHIBIT 2013 Page 10
`
`
`
`1011
`
`
`1012
`
`
`1013
`
`
`1014-1017
`
`1018
`
`
`1019
`
`1020
`
`
`1021
`
`
`1022
`
`
`1023
`
`
`
`Randolph, et al., U.S. Patent Application Publication No.
`US/2005/0058728 A1, “Cytokine Modulators and Related
`Method of Use” (Randolph)
`
`Sampalis [I] et al., “Evaluation of the Effects of Neptune Krill
`Oil™ on the Management of Premenstrual Syndrome and
`Dysmenorrhea” Altern. Med. Rev. 8(2):171-179 (2003)
`(Sampalis I)
`
`Sampalis [II] et al., WO 2003/011873, published February 13,
`2003, “Natural Marine Source Phospholipids Comprising
`Flavonoids, Polyunsaturated Fatty Acids and Their
`Applications” (Sampalis II)
`
`RESERVED
`
`Kochian et al, “Agricultural Approaches to Improving
`Phytonutrient Content in Plants: An Overview”, Nutrition
`Reviews, Vol. 57, No. 9, September 1999: S13-S18.
`
`RESERVED
`
`Bunea, et al., “Evaluation Of The Effects Of Neptune Krill Oil
`On The Clinical Course Of Hyperlipidemia”, Altern Med Rev.
`2004; 9:420–428 (Bunea).
`
`Complaint filed in Aker Biomarine Antarctic AS v. Olympic
`Holding AS, et al., Case No. 1:16-cv-00035
`
`RESERVED
`
`Federal Register Notice of Institution of Investigation 337-TA-
`1019 on September 16, 2016 by the ITC (81 Fed. Reg. pages
`63805-63806)
`
`AKER EXHIBIT 2013 Page 11
`
`
`
`1024
`
`
`
`
`
`
`
`
`
`
`
`1025-1034
`
`1035
`
`
`1036-1037
`
`1039
`
`
`1040-1042
`
`1043
`
`
`1044-1046
`
`1047
`
`1048-1053
`
`File History to U.S. Patent No. 9,034,388 B2, Serial No,
`12/057,775 (‘388 File History)
`1024 Part 1 - Pages 1-450
`1024 Part 2 - Pages 451-900
`1024 Part 3 - Pages 901-1350
`1024 Part 4 - Pages 1351-1800
`1024 Part 5A - Pages 1801-2025
`1024 Part 5B - Pages 2026-2250
`1024 Part 6 - Pages 2251-2700
`1024 Part 7 - Pages 2701-3083
`1024 Part 8 - Pages 3084-3223
`
`RESERVED
`
`
`
`
`
`Breivik, U.S. Patent Application Publication No. US
`2010/0143571 A1, “Process for Production of Omega-3 Rich
`Marine Phospholipids from Krill” (Breivik I).
`
`RESERVED
`
`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
`
`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) (‘388 Pat.App.Pub.).
`
`RESERVED
`
`U.S. Patent No. 9,034,388 B2, filed May 28, 2008 (‘388 Patent)
`
`RESERVED
`
`AKER EXHIBIT 2013 Page 12
`
`
`
`
`
`1054
`
`
`1055
`
`
`
`
`
`
`1056
`
`
`1057
`
`1058
`
`
`1059-1062
`
`1063
`
`
`
`
`
`
`1064
`
`
`
`Notice of Commission Determination ending Investigation 337-
`TA-1019, dated May 23, 2017.
`
`File History to U.S. Patent No. 9,375,453 B2, Serial No,
`14/020,162 (‘453 File History)
`
`1055 Part 1 - Pages 1-400
`1055 Part 2 - Pages 401-800
`1055 Part 3 - Pages 801-1109
`
`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 (also
`copy in Exhibit 1063, Part 3, pp. 1032-1097)
`
`RESERVED
`
`IDS filed March 17 2017 in file history for US Patent No.
`9644170, Serial No. 15180439
`
`RESERVED
`
`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
`
`Sampalis [III] et al., WO 2009/132463, published November 5,
`2009, “New Deodorization Method And Organoleptic
`Improvement Of Marine Oil Extracts” (Sampalis III)
`
`AKER EXHIBIT 2013 Page 13
`
`
`
`1065-1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`
`1071
`
`
`1072
`
`
`1073
`
`
`RESERVED
`
`U.S. Patent No. 9,375,453 B2, filed September 6, 2013 (‘453).
`
`RESERVED
`
`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).
`
`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.
`
`RESERVED
`
`AKER EXHIBIT 2013 Page 14
`
`
`
`1074
`
`
`1075
`
`
`1076
`
`
`
`1077
`
`1078
`
`
`1079
`
`1080
`
`
`1081-1084
`
`1085
`
`
`1086-1088
`
`
`Bruheim, et al., US 8,557,297 B2, “Method for Processing
`Crustaceans and Products Thereof”, issued October 15, 2013.
`
`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 regarding
`Krill Bill, Aquasource and FDA related webpages from 2006.
`
`RESERVED
`
`Del. District Court Stay of 16-cv-00035, pending resolution of
`IPRs, Order dated September 6, 2017.
`
`RESERVED
`
`Hoem, N., “Composition of Antarctic krill oil and methods for
`its harvesting, production and qualitative and quantitative
`analysis”, Aker BioMarine, Newcastle Australia November
`2013 (Hoem).
`
`RESERVED
`
`Bruheim, U.S. Patent Application Publication No. US
`2012/0149867 A1, “Method for Processing Crustaceans and
`Products Thereof ”, published June 14, 2012, filed January 3,
`2012.
`
`RESERVED
`
`AKER EXHIBIT 2013 Page 15
`
`
`
`Aker GRAS [No. GRN 000371], “Notification of GRAS
`Determination of Krill Oil”, December 14, 2010.
`https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GR
`ASNotices&id=371
`
`RESERVED
`
`Neptune GRAS Agency Response Letter GRN 000242.
`
`1089
`
`
`1090
`
`1091
`
`
`
`
`
`
`AKER EXHIBIT 2013 Page 16
`
`
`
`
`
`THE PETITION
`
`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. §§
`
`321-329 and 37 C.F.R. § 42.200 et seq., to institute a post grant review and to find
`
`unpatentable and cancel Claims 1-20 of U.S. Patent No. 9,644,170, entitled
`
`“Bioeffective Krill Oil Compositions,” issued May 9, 2017 (Serial No.
`
`15/180,439), filed June 13, 2016 (“the ‘170 patent”), assigned to Aker Biomarine
`
`Antarctic AS (“Aker”). The ‘170 Patent is submitted herewith as Exhibit 1001.
`
`
`
`It is more likely than not that at least one of the claims challenged in this
`
`petition is unpatentable. 35 U.S.C. § 324(a).
`
` MANDATORY NOTICES
`
`As set forth below and pursuant to 37 C.F.R. § 42.8(a)(1), the following
`
`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
`
`AS, Rimfrost USA, LLC, Rimfrost New Zealand Limited, Bioriginal Food and
`
`Science Corp., and Petitioner, Rimfrost AS, are identified as the real parties-in-
`
`AKER EXHIBIT 2013 Page 17
`
`
`
`interest. Several other entities have a majority ownership interest in the above-
`
`identified real parties-in-interest. Based upon those ownership interests, and in an
`
`abundance of caution, Petitioner also names Stig Remøy, SRR Invest AS, Rimfrost
`
`Holding AS, and Omega Protein Corporation as real parties-in-interest.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`Aker has asserted two patents - U.S. Patent Nos. 9,078,905 and 9,028,877 -
`
`in a pending lawsuit brought by Aker Biomarine Antarctic AS against Olympic
`
`Holding AS; Rimfrost AS; Emerald Fisheries AS, Rimfrost USA, LLC; Avoca
`
`Inc.; and Bioriginal Food & Science Corp. Case No. 1:16-CV-00035-LPS-CJB (D.
`
`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
`
`International Trade Commission on September 16, 2016 as noticed in the Federal
`
`Register. The ITC proceeding, entitled In the Matter of Certain Krill Oil Products
`
`and Krill Meal for Production of Krill Oil Products, related to U.S. Patent Nos.
`
`9,028,877, 9,078,905, 9,072,752, 9,320,765 and 9,375,453. The ITC investigation
`
`listed as respondents Olympic Holding AS, Rimfrost AS, Emerald Fisheries AS,
`
`Avoca Inc., Rimfrost USA, LLC, Rimfrost New Zealand Limited and Bioriginal
`
`Food & Science Corp. (Exhibit 1023). On May 23, 2017, pursuant to motions to
`
`AKER EXHIBIT 2013 Page 18
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`
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`terminate, ITC Investigation No. 337-TA-1019 was effectively terminated.
`
`(Exhibit 1054). In addition, a Stipulation of Dismissal as to Avoca Inc. was So
`
`Ordered by the Delaware District Court on May 30, 2017. On January 27, 2017,
`
`Petitioner filed IPR2017-0745 and IPR2017-0747 seeking inter partes review of
`
`Claims 1-20 of U.S. Patent No. 9,078,905. On February 3, 2017, Petitioner filed
`
`IPR2017-0746 and IPR2017-0748 seeking inter partes review of Claims 1-19 of
`
`U.S. Patent No. 9,028,877. All IPRs were instituted on August 16, 2017. The
`
`Delaware District Court action was stayed by the Court on September 6, 2017
`
`pending resolution of the IPRs. (Exhibit 1078). On December 15, 2017 Petitioner
`
`filed IPR 2018-00295 seeking inter partes review of Claims 1-48 of U.S. Patent
`
`No. 9,320,765. There has not been an institution decision for this IPR.
`
`C. Counsel (37 C.F.R. §§ 42.8(b)(3) and 42.10(a))
`
`Petitioner designates the following individuals as its lead counsel and back-
`
`up lead counsel:
`
`Lead Counsel:
`
`Back-up Lead Counsel
`
`James F. Harrington
`Reg. No. 44,741
`Hoffmann & Baron, LLP
`jfhdocket@hbiplaw.com
`(516) 822-3550
`
`Michael I. Chakansky
`Reg. No. 31,600
`Hoffmann & Baron, LLP
`micdocket@hbiplaw.com
`(973) 331-1700
`
`
`AKER EXHIBIT 2013 Page 19
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`
`
`
`
`
`
`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
`
`D.
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Service on Petitioner may be made electronically by using the following e-
`
`mail address: 170pgr@hbiplaw.com and the e-mail addresses above. Service on
`
`Petitioner may be made by Postal Mailing or Hand-Delivery addressed to Lead and
`
`Back-up Lead Counsel at the following address, but electronic service above is
`
`requested:
`
`Hoffmann & Baron, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
`
`This document, together with all exhibits referenced herein, has been served
`
`on the patent owner at its corporate headquarters, Oskenøyveien 10 No-1327, 1366
`
`Lysaker, Norway, as well as the correspondence address of record for the ‘170
`
`AKER EXHIBIT 2013 Page 20
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`
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`patent: Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton, Wisconsin
`
`53562.
`
` PAYMENT OF FEES
`
`Pursuant to 37 C.F.R. §§ 42.203 and 42.15(b), the requisite filing fee of
`
`$42,125 (request fee of $16,000, post-institution fee of $22,000 and excess claims
`
`fee of $4,125) for a Petition for Post Grant Review is submitted herewith. Claims
`
`1-20 of the ‘170 patent are being reviewed as part of this Petition. The
`
`undersigned further authorizes payment from Deposit Account No. 08-2461 for
`
`any additional fees or refund that may be due in connection with the Petition.
`
` ADDITIONAL REQUIREMENTS FOR POST-GRANT REVIEW
`
`A. Grounds For Standing (37 C.F.R. § 42.204(a)
`
`Petitioner hereby certifies that the ‘170 patent is available for Post Grant
`
`Review and that Petitioner is not barred or estopped from requesting Post Grant
`
`Review challenging the claims of the ‘170 patent on the grounds identified herein.
`
`This petition is filed within 9 months of the May 9, 2017 issue date of the
`
`‘170 patent. In addition, in Section VI infra, pp. 19-44, Petitioner details why
`
`Patent Owner is only entitled to its actual filing date of June 13, 2016, thus
`
`making the ‘170 patent subject to AIA and eligible for Post Grant Review.
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`AKER EXHIBIT 2013 Page 21
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`
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`B.
`
`Level Of Ordinary Skill In The Art
`
`As of the earliest priority date the ‘170 patent is entitled to (i.e., no earlier
`
`than June 13, 2016), a person of ordinary skill in the art (“POSITA”) would have
`
`held an advanced degree in marine sciences, biochemistry, organic (especially
`
`lipid) chemistry, chemical or process engineering, or associated sciences with
`
`complementary understanding, either through education or experience, of organic
`
`chemistry and in particular lipid chemistry, chemical or process engineering,
`
`marine biology, nutrition, or associated sciences; and knowledge of or experience
`
`in the field of extraction. In addition, a POSITA would have had at least five years
`
`applied experience. (Declaration of Dr. Stephen Tallon, hereafter “Tallon Decl.
`
`(Exhibit 1006),” ¶ 35).
`
`C.
`
`Identification Of Challenge And Relief Requested
`(37 C.F.R. § 42.204(b) And 37 C.F.R. § 42.22(a)(1))
`
`The precise relief requested by Petitioner is that Claims 1-20 are found
`
`unpatentable and cancelled from the ‘170 patent.
`
`1.
`
`Claims for which Post-Grant Review is Requested
`(37 C.F.R. § 42.204(b)(2))
`
`Petitioner requests Post Grant Review of Claims 1-20 of the ‘170 patent.
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`AKER EXHIBIT 2013 Page 22
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`
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`2.
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`Specific Statutory Grounds on which the Challenge is Based
`(37 C.F.R. § 42.204(b)(2))
`
`The specific statutory grounds for the challenge are as follows:
`
`Ground
`
`
`1
`
`2
`
`3
`
`4
`5
`
`6
`
`7
`
`8
`
`Reference(s)
`
`Basis
`
`
`
`
`
`
`
`‘388 Pat.App.Pub.
`Bruheim and Neptune’s
`GRAS
`
`Neptune’s GRAS, Bruheim
`and Sampalis III
`Neptune’s GRAS, Bruheim
`and Randolph
`Neptune’s GRAS, Bruheim
`and Bottino I
`
`35 U.S.C. §112(a)
`Lack of possession/
`enablement/written
`description
`35 U.S.C. §101
`Product of Nature
`35 U.S.C. §101
`Lack of Inventorship
`35 U.S.C. §102(a)
`35 U.S.C. §103(a)
`
`35 U.S.C. §103(a)
`
`35 U.S.C. §103(a)
`
`35 U.S.C. §103(a)
`
`Claims
`Challenged
`1-20
`
`1-20
`
`1-20
`
`1-20
`1, 3-5, 7, 9-
`11, 13-16,
`18, 20
`2, 12
`
`6, 17
`
`8, 19
`
`3.
`
`Earliest Effective Priority Date
`
`The ‘170 patent is a continuation application of Application No. 14/020,162
`
`filed on September 6, 2013, now U.S. Patent No. 9,375,453, which is a
`
`continuation of Application No. 12/057,775, filed on March 28, 2008, now U.S.
`
`Patent No. 9,034,388. (See Priority Chart, infra, p. 20). The ‘170 patent claims
`
`AKER EXHIBIT 2013 Page 23
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`
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`priority to several applications. As detailed in Section VI, infra, pp. 19-44, Patent
`
`Owner failed to comply with the requirements of 35 U.S.C. § 112(a) because the
`
`claimed amounts of ether phospholipids, astaxanthin esters, and trimethylamine
`
`lack sufficient support, and thus cannot support a claim priority to any of its
`
`priority applications. As a result, the ‘170 patent is not entitled to a priority date
`
`earlier than the actual filing date of the application that issued as the ‘170 patent,
`
`i.e., June 13, 2016. (Tallon Decl. (Exhibit 1006), ¶¶ 85-132).
`
`4.
`
`Prior Art References
`
`All prior art references utilized herein were published more than one year
`
`prior to the filing date of June 13, 2016, and therefore qualify as prior art under 35
`
`U.S.C. § 102(b).
`
`
`
`
`
`AKER EXHIBIT 2013 Page 24
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`
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`§ 102(b) Reference
`
`Publication Date
`
`Exhibit No.
`
`‘388 Pat.App.Pub.
`
`November 6, 2008
`
`Bruheim
`
`June 14, 2012
`
`Neptune’s GRAS
`
`At least as early as
`
`December 14, 2010.1
`
`Sampalis III
`
`November 5, 2009
`
`Randolph
`
`Bottino I
`
`March 17, 2005
`
`June 28, 1974
`
`1043
`
`1085
`
`1075
`
`1064
`
`1011
`
`1007
`
`
`
`D. Claim Construction-Broadest Reasonable Interpretation (“BRI”)
`(37 C.F.R. § 42.204(B)(3))
`
`In a Post Grant Review, the Board interprets claim terms in an unexpired
`
`patent according to the broadest reasonable construction in light of the
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b); see
`
`1 As of December 14, 2010, Patent Owner, Aker, filed a GRAS Notification
`
`(Exhibit 1089) with the FDA for its commercial krill oil product. The Aker GRAS
`
`Notification expressly references Neptune’s GRAS filing (Exhibit 1075). (Aker
`
`GRAS (Exhibit 1089), pp. 1, 14).
`
`AKER EXHIBIT 2013 Page 25
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`
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`Cuozzo Speed Techs. v. Lee, LLC, 136 S. Ct. 2131, 2142–46 (2016). Under that
`
`standard, and absent any special definitions, we give claim terms their ordinary and
`
`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
`
`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth with
`
`reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475,
`
`1480 (Fed. Cir. 1994).
`
`
`
`SUMMARY OF THE ‘170 PATENT (EXHIBIT 1001)
`
`A. Background Of The ‘170 Patent
`
`The ‘170 patent relates to krill oil compositions defined in terms of amounts
`
`of certain components that are naturally present in Antarctic krill (e.g., ether
`
`phospholipids and astaxanthin esters).
`
`In the Detailed Description of the Invention, the ‘17