`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.: IPR2017-00746
`
`U.S. Patent 9,028,877
`
`Issue Date: May 12, 2015
`
`Title: Bioeffective Krill Oil Compositions
`
`_______________
`
`PETITION FOR INTER PARTES REVIEW
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.1 ET SEQ.
`
`
`
`
`
`
`
`Inter Partes Review Case No.: IPR2017-00746
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`
`
`U.S. Patent No. 9,028,877
`
`TABLE OF CONTENTS
`THE PETITION ............................................................................................... 1
`
`I.
`
`II. 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
`
`III.
`
`PAYMENT OFFICE FEES ............................................................................. 4
`
`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW ............ 5
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) ..................................... 5
`
`B.
`
`C.
`
`Level or Ordinary Skill in the Art ......................................................... 5
`
`Identification of Challenge and Relief Requested (37 C.F.R. §
`42.104(b) and 37 C.F.R. § 42.22(a)(1)) ................................................ 6
`
`1. Claims for which Inter Partes Review is Requested
`(37 C.F.R. §42.104(b)(2)) ............................................................ 6
`
`2. Specific Statutory Grounds on which the Challenge is Based
`(37 C.F.R. § 42.104(b)(2)) .......................................................... 6
`
`3. Earliest Effective Priority Date ....................................................... 7
`
`4. Prior Art References ....................................................................... 7
`
`D.
`
`Claim Construction - Broadest Reasonable Interpretation (“BRI”) (37
`C.F.R. § 42.104(b)(3)) ........................................................................... 9
`
`V.
`
`SUMMARY OF THE ‘877 PATENT (EXHIBIT 1001) ................................ 9
`
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`Inter Partes Review Case No.: IPR2017-00746
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`U.S. Patent No. 9,028,877
`
`A.
`
`B.
`
`C.
`
`D.
`
`State of the Art ...................................................................................... 9
`
`Background of ‘877 Patent ..................................................................11
`
`Prosecution History of the ‘877 Patent ...............................................14
`
`Construction of the ‘877 Patent Claim Terms.....................................19
`
`1. Claims 1 and 11 - “krill oil” ........................................................... 19
`
`2. Claims 1 and 11 – “denature lipases and phospholipases” ............ 21
`
`3. Claims 1 and 11 – “polar solvent” ................................................. 25
`
`4. Claims 3 and 11 - “freshly harvested krill” ................................... 27
`
`5. Claim 6 - “polar entrainer” ............................................................ 29
`
`VI. EACH GROUND PROVIDES MORE THAN A REASONABLE
`LIKELIHOOD THAT EACH CLAIM OF THE ‘877 PATENT IS
`UNPATENTABLE ........................................................................................30
`
`A. Ground 1: §103(a) – Breivik, Catchpole, and Fricke [Claims 1-3, 6,
`8-9, 11-12, 15 and 17-18] ....................................................................31
`
`1. Claims 1 and 11
`
` ....................................................................... 44
`
`2. Claims 2 and 12
`
` ....................................................................... 44
`
`3. Claim 3
`
` ....................................................................... 44
`
`4. Claims 6 and 15
`
` ....................................................................... 45
`
`5. Claims 8 and 17
`
` ....................................................................... 47
`
`6. Claims 9 and 18
`
` ....................................................................... 48
`
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`U.S. Patent No. 9,028,877
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`B.
`
`Ground 2: §103(a) – Breivik, Fricke, Bottino, and Catchpole
`[Claims 4-5, and 13-14] ......................................................................51
`
`1. Claims 4 and 13
`
` ....................................................................... 51
`
`2. Claims 5 and 14
`
` ....................................................................... 55
`
`C.
`
`Ground 3: §103(a) to Breivik, Fricke, Sampalis I, and Catchpole
`[Claims 7 and 16] ................................................................................59
`
`D. Ground 4: §103(a) – Breivik, Fricke, Catchpole, and Sampalis II
`[Claims 10 and 19] ..............................................................................61
`
`E.
`
`CLAIM CHART..................................................................................63
`
`VII. CONCLUSION ..............................................................................................82
`
`VIII. CERTIFICATE OF COMPLIANCE ............................................................83
`
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`U.S. Patent No. 9,028,877
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`APPENDIX OF EXHIBITS
`
`EXHIBIT
`NO.
`
`
`1001
`
`1002
`
`
`1003
`
`
`1004
`
`
`1005
`
`
`1006
`
`1007
`
`
`1008
`
`
`1009
`
`
`1010
`
`
`
`EXHIBIT DESCRIPTION
`
`U.S. Patent No. 9,028,877 B2, filed September 18, 2014 (‘877)
`
`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 Dr. Stephen Tallon
`
`Bottino, N.R.,“The Fatty Acids of Antarctic Phytoplankton and
`Euphausiids. Fatty Acid Exchange among Trophic Levels of the Ross
`Sea”, Marine Biology, 27, 197-204 (1974) (Bottino)
`
`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 Antactic
`Krill (Euphausia superba Dana),” LIPIDS 19(11):821-827 (1984)
`(Fricke)
`
`- iv -
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`1011
`
`Randolph, et al., U.S. Patent Application Publication No.
`US/2005/0058728 A1, “Cytokine Modulators and Related Method of
`Use”(Randolph)
`
`U.S. Patent No. 9,028,877
`
`
`1012
`
`
`1013
`
`
`1014
`
`
`1015
`
`
`1016
`
`
`1017
`
`
`1018
`
`
`
`
`
`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,” U.S. 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).
`
`Kochian et al, “Agricultural Approaches to Improving Phytonutrient
`Content in Plants: An Overview,” Nutrition Reviews”, Vol. 57, No. 9,
`September 1999: S13-S18.
`
`- v -
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`Inter Partes Review Case No.: IPR2017-00746
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`1019
`
`Porzio et al., “Encapsulation Compositions and Processes for
`Preparing the Same,” U.S. Patent No. 7,488,503 B1 filed March 31,
`2004 (Porzio).
`
`U.S. Patent No. 9,028,877
`
`
`1020
`
`
`1021
`
`
`1022
`
`
`1023
`
`
`1024
`
`
`
`
`
`
`
`
`
`
`1025
`
`
`
`
`
`
`
`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., 1:16-CV-00035-LPS-CJB (D. Del).
`
`Affidavits of Service Filed in Aker Biomarine Antarctic AS v. Olympic
`Holding AS, et al., No. 1:16-CV-00035 LPS-CJB
`(D. Del).
`
`
`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
`
`File History to U.S. Patent No. 9,028,877 B2, Serial No, 14/490,176
`(‘877 File History)
`
`1025 Part 1 - Pages 1-375
`1025 Part 2 - Pages 376-724
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`1026
`
`File History to U.S. Patent No. 9,078,905 B2, Serial No, 14/490,221
`(‘905 File History)
`
`U.S. Patent No. 9,028,877
`
`
`
`
`
`1027
`
`
`1028
`
`
`1029
`
`
`1030
`
`
`1031
`
`
`1032
`
`
`1033
`
`
`1032
`
`
`
`
`1026 Part 1 - Pages 1-450
`1026 Part 2 - Pages 451-882
`
`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)
`
`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).
`
`Grantham, G.J., “The Utilization Of Krill”, UNDP/FAO
`Southern Ocean Fisheries Survey Programme (1977) (Grantham).
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`1033
`
`Yoshitomi, U.S. Patent Application Publication No.
`US/2003/0113432 A1, “Process For Making Dried Powdery and
`Granular Krill” (Yoshitomi).
`
`U.S. Patent No. 9,028,877
`
`
`1034
`
`
`1035
`
`
`1036
`
`
`1037
`
`Kolakowska, A., “The influence of sex and maturity stage of krill
`(Euphausia superba Dana) upon the content and composition of its
`lipids”, 1991, Pol. Polar Res. 12: 73-78 (Kolakowska).
`
`Breivik, U.S. Patent Application Publication No. US 2010/0143571
`A1, “Process for Production of Omega-3 Rich Marine Phospholipids
`from Krill” (Breivik).
`
`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, WO 2008/060163 A1, “Process for Production of Omega-3
`Rich Marine Phospholipids from Krill,” International filing date
`November 15, 2007 (Breivik PCT).
`
`
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`- viii -
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`Inter Partes Review Case No.: IPR2017-00746
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`I.
`
`THE PETITION
`
`U.S. Patent No. 9,028,877
`
`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 1-19 of U.S. Patent No. 9,028,877, entitled
`
`“Bioeffective Krill Oil Compositions,” issued May 12, 2015 (Serial No.
`
`14/490,176, filed September 18, 2014) (“the ‘877 patent”), assigned to Aker
`
`Biomarine Antarctic AS (“Aker”). The ‘877 patent is submitted herewith as
`
`Exhibit 1001. There is a reasonable likelihood that Petitioner will prevail with
`
`respect to at least one claim challenged in this petition.
`
`II. 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, Avoca Inc., Rimfrost USA, LLC, Rimfrost New Zealand Limited,
`
`Bioriginal Food and Science Corp., and Petitioner, Rimfrost AS, are identified as
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`Inter Partes Review Case No.: IPR2017-00746
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`the real parties-in-interest. Several other entities have a majority ownership
`
`U.S. Patent No. 9,028,877
`
`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, Pharmachem Laboratories, Inc.,
`
`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 lawsuit captioned Aker Biomarine Antarctic AS v. Olympic Holding AS; Rimfrost
`
`AS; Emerald Fisheries AS, Rimfrost USA, LLC; Avoca Inc.; and Bioriginal Food &
`
`Science Corp. Case No. 1:16-CV-00035-LPS-CJB (D. Del.). (Complaint, Exhibit
`
`1021). The litigation is presently pending, although it has been stayed 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 is entitled In the Matter of Certain Krill Oil Products and Krill Meal for
`
`Production of Krill Oil Products and concerns U.S. Patent Nos. 9,028,877;
`
`9,078,905; 9,072,752; 9,320,765; and 9,375,453. The ITC investigation lists as
`
`respondents Olympic Holding AS, Rimfrost AS, Emerald Fisheries AS, Avoca Inc.,
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`Inter Partes Review Case No.: IPR2017-00746
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`Rimfrost USA, LLC, Rimfrost New Zealand Limited and Bioriginal Food & Science
`
`U.S. Patent No. 9,028,877
`
`Corp. (Exhibit 1023). 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.
`
`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
`
`Ronald J. Baron
`Reg. No. 29,281
`Hoffmann & Baron, LLP
`rjbdocket@hbiplaw.com
`(516)822-3550
`
`John T. Gallagher
`Reg. No. 35,516
`Hoffmann & Baron, LLP
`jtgdocket@hbiplaw.com
`(516)822-3550
`
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`3
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`Inter Partes Review Case No.: IPR2017-00746
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`U.S. Patent No. 9,028,877
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`D.
`
`Service information (37 C.F.R. §42.8(b)(4))
`
`Service on Petitioner may be made electronically by using the following
`
`email address: 877ipr1@hbiplaw.com and the email 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
`
`‘877 patent: Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton,
`
`Wisconsin 53562, and the address of Patent Owner’s litigation counsel: Andrew
`
`F. Pratt, Esq. Venable LLP, 575 Seventh Street NW, Washington, DC 20004.
`
`III. PAYMENT OFFICE FEES
`
`Pursuant to 37 C.F.R. §§ 42.103 and 42.15(a), the requisite filing fee of
`
`$24,600 (request fee of $9,000, post-institution fee of $14,000 and excess claims
`
`
`
`
`4
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`Inter Partes Review Case No.: IPR2017-00746
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`fee of $1,600) for a Petition for Inter Partes Review is submitted herewith.
`
`U.S. Patent No. 9,028,877
`
`Claims 1-19 of the ‘877 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.
`
`IV. ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Petitioner hereby certifies that the ‘877 patent is available for Inter Partes
`
`Review and that Petitioner is not barred or estopped from requesting Inter Partes
`
`Review challenging the claims of the ‘877 patent on the grounds identified herein.
`
`This Petition is timely filed under 35 U.S.C. §315(b) because it is filed within one
`
`year of the service of the Complaint alleging infringement of the ‘877 patent by
`
`Aker. See Exhibits 1021-1022.
`
`B. Level or Ordinary Skill in the Art
`
`As of the earliest priority date the ‘877 Patent is entitled to, (i.e., January
`
`28, 2008), a 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
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`through education or experience, of organic chemistry and in particular lipid
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`U.S. Patent No. 9,028,877
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`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.
`
`(Tallon Decl. ¶27).
`
`C.
`
`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 1-19 are found
`
`unpatentable and cancelled from the ‘877 patent.
`
`1.
`
`Claims for which Inter Partes Review is Requested(37
`C.F.R. §42.104(b)(2))
`
`Petitioner requests Inter Partes Review of Claims 1-19 of the ‘877 patent.
`
`2.
`
`Specific Statutory Grounds on which the Challenge is
`Based (37 C.F.R. § 42.104(b)(2))
`
`The specific statutory grounds for the challenge are as follows:
`
`Ground
`
`References
`
`Basis
`
`Claims Challenged
`
`1
`
`2
`
`Breivik, Catchpole,
`and Fricke
`Breivik, Catchpole, Fricke,
`and Bottino
`
`35 U.S.C. §103(a)
`
`35 U.S.C. §103(a)
`
`1-3, 6, 8-9, 11-12,
`15 and 17-18
`4-5 and 13-14
`
`
`
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`6
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`Inter Partes Review Case No.: IPR2017-00746
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`U.S. Patent No. 9,028,877
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`Ground
`
`References
`
`Basis
`
`Claims Challenged
`
`3
`
`4
`
`Breivik, Catchpole, Fricke,
`and Sampalis I
`Breivik, Catchpole, Fricke,
`and Sampalis II
`
`35 U.S.C. §103(a)
`
`7 and 16
`
`35 U.S.C. §103(a)
`
`10 and 19
`
`Petitioner also relies on the expert declaration of Dr. Stephen Tallon
`
`(Exhibit 1006).
`
`3.
`
`Earliest Effective Priority Date
`
`All of the issued claims in the ‘877 patent require the element that the krill
`
`oil comprise from about 3% to about 10% w/w ether phospholipids. Support for
`
`the claim element “ether phospholipid” was not introduced until the filing of U.S.
`
`Application No. 61/024,072, filed on January 28, 2008. (See Exhibits 1002-1005).
`
`Consequently, the earliest effective priority date for the claims of the ‘877 patent
`
`is January 28, 2008. (See Tallon Dec. ¶ 34).
`
`4.
`
`Prior Art References
`
`Other than Catchpole and Breivik, all prior art references utilized herein
`
`were published more than one year prior to the earliest possible priority date of
`
`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
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`U.S. Patent No. 9,028,877
`
`U.S.C. §102(e)1. Breivik claims priority to U.S. provisional application No.
`
`60/859,289 (Exhibit 1036) filed November 16, 2006 and was filed as a PCT
`
`application on November 15, 2007 (Exhibit 1037).
`
`
`
`§102(b) Reference
`
`Publication Date
`
`Exhibit No.
`
`Fricke
`
`Sampalis I
`
`Bottino
`
`April 30, 1984
`
`May 2003
`
`June 28, 1974
`
`Sampalis II
`
`February 13, 2003
`
`1010
`
`1012
`
`1007
`
`1013
`
`
`
`§102(e) Reference
`
`Effective Filing Date
`
`Exhibit No.
`
`Catchpole
`
`April 20, 2007
`
`Breivik
`
`November 16, 2006
`
`1009
`
`1035
`
`
`
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`1 Catchpole is also a prior art reference under 35 U.S.C. § 102(a).
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`U.S. Patent No. 9,028,877
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`D. Claim Construction - Broadest Reasonable Interpretation
`(“BRI”) (37 C.F.R. § 42.104(b)(3))
`
`In an inter partes review, claim terms are interpreted according to their
`
`broadest reasonable construction in light of the specification of the patent in which
`
`they appear. 37 C.F.R. § 42.100(b); Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48756 and 48766 (Aug. 14, 2012).
`
`Solely for this proceeding, the Section V. D. contains the proposed terms
`
`for construction and Petitioner's proposed constructions. All other terms, not
`
`presented below, should be given their plain and ordinary meaning. Petitioner
`
`reserves the right to address any claim construction issue raised by Patent Owner.
`
`V.
`
`SUMMARY OF THE ‘877 PATENT (EXHIBIT 1001)
`
`A.
`
`State of the Art
`
`All of the claims issued in the ‘877 Patent are directed to methods of
`
`producing krill oil. The steps of the methods include providing and treating krill
`
`(e.g., by heating) to denature lipases and phospholipases and extracting oil using a
`
`polar solvent. Independent Claim 1 requires the denaturation step to be performed
`
`“on a ship,” while independent Claim 11 requires the denaturation be performed
`
`on “freshly harvested krill.” However, such steps were well known in the art as of
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`the earliest effective filing date.
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`U.S. Patent No. 9,028,877
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`For example, Budziński (Exhibit 1008) recognized the need to process
`
`freshly harvested krill to ensure the optimum product quality. “Due to its
`
`technological properties, the raw material should be processed as soon as possible
`
`after capture. The only way to meet this requirement is to install processing
`
`facilities on board the vessel.” (Exhibit 1008, p. 0031, sec. 4.9, lines 2-4.) (Tallon
`
`Decl. ¶ 81.).
`
`Budziński further discloses cooking and pressing krill on board the ship to
`
`produce a denatured product—krill meal. (Exhibit 1008, p. 002620, sec. 4.5.1,
`
`lines 1-2, 6-8, 15-17, and 21-23.) (See Tallon Decl. ¶ 84). Budziński also
`
`discloses extracting oil with a polar solvent (“[k]rill oil was only obtained by
`
`extraction with the help of various organic solvents.” (Exhibit 1008, p. 0030, sec.
`
`4.7, line 12.) (Tallon Decl., ¶ 86).
`
`Similarly, Grantham discloses the problem of krill’s instability after
`
`catching and describes methods for processing (cooking) on board the ship before
`
`extracting krill lipids. (Exhibit 1032, p. 0026, section 3.1; pp. 0033-0034, section
`
`3.4.4; p. 0035, section 3.4.5; p. 0036, sec. 3.4.6.; p. 0039, section 3.4.8). (Tallon
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`Decl., ¶¶ 158-166).
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`U.S. Patent No. 9,028,877
`
`The claims of the ‘877 patent also specify percentages of components in the
`
`resulting krill oil. However, the krill oil components were well known to be
`
`naturally present in krill oil in the amounts specified using standard extraction
`
`techniques. (See, e.g., Section VI, infra; Exhibit 1034, Kolakowska (1991)).
`
`B.
`
`Background of ‘877 Patent
`
`
`
`The ‘877 patent “provides methods of production of krill oil comprising: a)
`
`providing fresh krill; b) treating said fresh krill to denature lipases and
`
`phospholipases in said fresh krill to provide a denatured krill product; and c)
`
`extracting oil from said denatured krill product,” wherein steps (a) and (b) are
`
`performed on board a ship. (Exhibit 1001, col. 4, lines 47-52). The Patentee of
`
`the‘877 patent also states that, “The present invention provides a Euphausia
`
`superba krill oil composition comprising: from about 30% to 60% w/w
`
`phospholipids; from about 20% to 50% triglycerides; from about 400 to about
`
`2500 mg/kg astaxanthin; and from about 20% to 35% omega-3 fatty acids as a
`
`percentage of total fatty acids in said composition, wherein from about 70% to
`
`95% of said omega-3 fatty acids are attached to said phospholipids.” (Exhibit
`
`
`
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`11
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`Inter Partes Review Case No.: IPR2017-00746
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`1001, col. 5, lines 49-56).
`
`U.S. Patent No. 9,028,877
`
`
`
`However, as acknowledged in the Background of the Invention:
`
`In order to isolate the krill oil from the krill, solvent
`
`extraction methods have been used. See, e.g., WO
`
`00/23546. Krill lipids have been extracted by placing the
`
`material in a ketone solvent (e.g. acetone) in order to
`
`extract the lipid soluble fraction. This method involves
`
`separating the liquid and solid contents by evaporation.
`
`Further processing
`
`steps
`
`include extracting and
`
`recovering by evaporation the remaining soluble lipid
`
`fraction from the solid contents by using a solvent such
`
`as ethanol. See e.g., WO 00/23546.”
`
`(Exhibit 1001, 1:31-40).
`
`
`
`Patentee also acknowledges that, “[t]he methods described above rely on the
`
`processing of frozen krill that are transported from the Southern Ocean to the
`
`processing site. This transportation is both expensive and can result in
`
`degradation of the krill starting material.” (Exhibit 1001, col. 2, lines 3-6).
`
`
`
`Patentee also states, “[s]upercritical fluid extraction with solvent modifier
`
`has previously been used to extract marine phospholipids from salmon roe, but
`
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`has not been previously used to extract phospholipids from krill meal. See, e.g.,
`
`U.S. Patent No. 9,028,877
`
`Tanaka et al., J. Oleo. Sci. (2004), 53(9), 417-424.” (Exhibit 1001, col. 1, line 65
`
`to col. 2, line 2). However, this statement is demonstrably false in view of the
`
`disclosure of Catchpole (Exhibit 1009 ) discussed further below. See also,
`
`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. (Exhibit 1031, p.
`
`0002, “Degussa is renowned for its expertise in supercritical CO2 extraction.”).
`
`
`
`With regard to krill compositions, Patentees admit, “[a] krill oil
`
`composition has been disclosed comprising a phospholipid and/or a flavonoid.
`
`The phospholipid content in the krill lipid extract could be as high as 60% w/w
`
`and the EPA/DHA content as high as 35% (w/w). See, e.g., WO 03/011873.”
`
`(Exhibit 1001, col. 1, lines 53-56).
`
`
`
`The analysis of the extracted krill oil is disclosed in the ‘877 patent in
`
`Table 21, which shows the amount of phospholipids, triglycerides and omega-3
`
`fatty acids in the extract. Tables 22 and 23 provide the only ether phospholipid
`
`data in the entire specification. Example 8 of the ‘877 patent concludes:
`
`
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`U.S. Patent No. 9,028,877
`
`The main polar ether lipids of the krill meal are
`
`alkylacylphosphatidylcholine (AAPC) at 7-9% of total
`
`polar lipids, lysoalkylacylphosphatidylcholine (LAAPC)
`
`at
`
`1%
`
`of
`
`total
`
`polar
`
`lipids
`
`(TPL)
`
`and
`
`alkylacylphosphatidyl-ethanolamine (AAPE) at <1% of
`
`TPL.
`
`(Tallon Decl. ¶ 210).
`
`All of the issued claims include the “from about 3% to about 10% w/w”
`
`ether phospholipid limitation and it appears to be the element that Patentee relies
`
`upon for novelty. However, as demonstrated herein, krill oil containing ether
`
`phospholipid levels between about 3% and about 10% was known in the prior art.
`
`C.
`
`Prosecution History of the ‘877 Patent
`
`
`
`The ‘877 patent issued on May 12, 2015 from U.S. Application No.
`
`14/490,176, filed September 18, 2014. The ‘877 patent is a continuation of U.S.
`
`Patent Application No. 12/057,775, filed on March 28, 2008 and claims the
`
`benefit of four U.S. provisional applications: 61/024,072, filed on January 28,
`
`2008; 60/983,446, filed on October 29, 2007; 60/975,058, filed on September 25,
`
`2007; and 60/920,483, filed on March 28, 2007. Support for the claim element
`
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`“ether phospholipid” – required by each ‘877 claim – was not introduced until the
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`U.S. Patent No. 9,028,877
`
`filing of the U.S. Application No. 61/024,072. (See Exhibits 1002-1005).
`
`Consequently, “the earliest priority date” for the claims of the ‘877 patent is
`
`January 28, 2008.
`
`
`
`During the prosecution of the ‘877 patent (Exhibit 1025), a final Office
`
`Action was mailed on January 13, 2015 in which all of the claims were rejected.
`
`Exhibit 1025, Part 1, pp. 0091-0097. After a telephone interview with the
`
`Applicant’s attorney on March 13, 2015, the Examiner issued a Notice of
`
`Allowance on April 6, 2015 with an Examiner’s Amendment. In the Examiner’s
`
`Amendment, claim 1 was amended to require steps (a) and (b) of the method to be
`
`performed on board a ship. Prior to the Examiner’s Amendment, Claim 1 did not
`
`require step (a) (providing krill) and step (b) (treating the krill) to be performed on
`
`board a ship. Thus, the Examiner only found Claim 1 to be allowable over the
`
`prior art if steps (a) and (b) were performed on board a ship. (Exhibit 1025, Part
`
`1, pp. 0011-0017).
`
`All of the claims of the ‘877 patent have the claim limitation of “from about
`
`3% to about 10% w/w ether phospholipids.” Applicant relied on this limitation in
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`Inter Partes Review Case No.: IPR2017-00746
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`asserting patentability of the claims.
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`U.S. Patent No. 9,028,877
`
`In parent application no. 12/057,775, which issued as U.S. Patent No.
`
`9,034,388, Applicant amended the claims to add the limitation “about 3% to about
`
`10% ether phospholipid” and argued that the cited references do not teach
`
`extraction of a krill oil having the amended limitations. (See Response to Office
`
`Action dated September 7, 2012.) The claims are directed to “a method of
`
`producing krill oil….from about 3% to about 10% w/w ether phospholipids”.
`
`(Exhibit 1024, Part 2, pp. 00633-0650).
`
`Furthermore, it is noted that in the prosecution history of U.S. Patent
`
`Application No. 9,078,905 (U.S. Patent Application No. 14/490,221), Applicants
`
`rely on the limitation of ether phospholipid levels in asserting patentability of the
`
`claims therein. (See Exhibit 1026).
`
`In particular, a Non-Final Office Action was mailed November 17, 2014
`
`(Exhibit 1026, part 1, pp. 0168-0177) that rejected all the as-filed claims. The
`
`Examiner asserted two United States Patents as prior art arguing that the
`
`disclosures these patents made the as-filed claims obvious: Beaudoin (Exhibit
`
`1016); and Porzio (Exhibit 1019). Beaudoin was characterized as disclosing krill
`
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`oil components including phospholipids and triglycerides at similar concentrations
`
`U.S. Patent No. 9,028,877
`
`as presented in the claims. This was combined with Porzio, which teaches how to
`
`encapsulate lipid compositions. A Response to the Non-Final Office Action was
`
`filed on December 19, 2014 (Ex
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