`
`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.: IPR2017-00745
`
`U.S. Patent 9,078,905
`
`Issue Date: July 14, 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.
`
`
`
`
`
`
`
`
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`Inter Partes Review Case No. IPR2017-00745
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`U.S. Patent No. 9,078,905
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`TABLE OF CONTENTS
`THE PETITION ...............................................................................................1
`
`I.
`
`
`
`
`
` MANDATORY NOTICES .............................................................................1 II.
`
`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 OF FEES ......................................................................................5
`
`
`
` ADDITIONAL REQUIREMENTS FOR INTER PARTES REVIEW ............5 IV.
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) .....................................5
`
`B.
`
`C.
`
`Level of 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)) ...........................6
`
`1.
`
`2.
`
`3.
`
`4.
`
`Claims for which Inter Partes Review is Requested
`(37 C.F.R. §42.104(b)(2)) ........................................................... 6
`
`Specific Statutory Grounds on which the
`Challenge is Based (37 C.F.R. § 42.104(b)(2)) .......................... 6
`
`Earliest Effective Priority Date ................................................... 7
`
`Prior Art References ................................................................... 8
`
`D.
`
`Claim Construction - Broadest Reasonable Interpretation
`(“BRI”) (37 C.F.R. § 42.104(b)(3)) ......................................................9
`
`V.
`
`
`
`SUMMARY OF THE ‘905 PATENT (EXHIBIT 1001) ............................. 12
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`Inter Partes Review Case No. IPR2017-00745
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`U.S. Patent No. 9,078,905
`
`A.
`
`B.
`
`C.
`
`Background of ‘905 Patent ................................................................ 12
`
`Prosecution History of the ‘905 Patent .............................................. 14
`
`Construction of the ‘905 patent Claim Terms ................................... 18
`
`1.
`
`2.
`
`3.
`
`4.
`
`Claims 1, 12, and 18 - “krill oil” .............................................. 18
`
`Claims 1, 12, and 18 – “an effective amount of krill oil” ........ 20
`
`Claim 4 - “polar solvent extract” .............................................. 21
`
`Claim 5 - “phytonutrient” ......................................................... 24
`
` EACH GROUND PROVIDES MORE THAN A REASONABLE VI.
`
`
`LIKELIHOOD THAT EACH CLAIM OF THE ‘905 PATENT IS
`UNPATENTABLE ....................................................................................... 26
`
`A. Ground 1: §103(a) – Catchpole and Sampalis I
`[Claims 1-4 and 9-10] ........................................................................ 26
`
`B.
`
`C.
`
`Ground 2: §103(a) – Catchpole, Sampalis I and Randolph
`Claim 5] .............................................................................................. 34
`
`Ground 3: §103(a) to Catchpole, Sampalis I and Fricke [Claims 6,
`12, 15-16, and 18] .............................................................................. 38
`
`D. Ground 4: §103(a) to Catchpole, Sampalis I, Fricke and Bottino
`[Claims 7-8, 13-14, 17, and 19-20] .................................................... 44
`
`E.
`
`Ground 5: §103(a) to Catchpole, Sampalis I, and Bottino [Claim 11]
` ............................................................................................................ 55
`
`F.
`
`CLAIM CHART ................................................................................. 56
`
`
`
` CONCLUSION ............................................................................................. 70 VII.
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` CERTIFICATE OF COMPLIANCE............................................................ 71 VIII.
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`
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`U.S. Patent No. 9,078,905
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`APPENDIX OF EXHIBITS
`
`U.S. Patent No. 9,078,905
`
`Exhibit
`Number
`
`1001
`
`1002
`
`
`1003
`
`
`1004
`
`
`1005
`
`
`1006
`
`1007
`
`
`1008
`
`
`1009
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`Exhibit Description
`
`
`
`
`
`U.S. Patent No. 9,078,905 B2, filed September 18, 2014 (‘905 Patent)
`
`U.S. Provisional Patent Application No. 61/024,072, filed January 28,
`2008 (‘072 Provisional)
`
`U.S. Provisional Patent Application No. 60/983,446, filed October
`29, 2007 (‘446 Provisional)
`
`U.S. Provisional Patent Application No. 60/975,058, filed September
`25, 2007 (‘058 Provisional)
`
`U.S. Provisional Patent Application No. 60/920,483, filed March 28,
`2007 (‘483 Provisional)
`
`Declaration of Stephen Tallon (Tallon Decl.)
`
`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)
`
`- iv -
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`Inter Partes Review Case No. IPR2017-00745
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`
`1010
`
`Fricke et al., “Lipid, Sterol and Fatty Acid Composition of Antactic
`Krill (Euphausia superba Dana),” LIPIDS 19(11):821-827
`(1984) (Fricke)
`
`U.S. Patent No. 9,078,905
`
`
`1011
`
`
`1012
`
`
`
`1013
`
`
`1014
`
`
`1015
`
`
`1016
`
`
`
`
`
`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,” U.S. Patent No. 6,800,299 B1 filed
`July 25, 2001 (Beaudoin).
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`Inter Partes Review Case No. IPR2017-00745
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`1017
`
`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).
`
`U.S. Patent No. 9,078,905
`
`
`1018
`
`
`1019
`
`
`1020
`
`
`1021
`
`
`1022
`
`
`
`1023
`
`
`1024
`
`Kochian et al, “Agricultural Approaches to Improving Phytonutrient
`Content in Plants: An Overview,” Nutrition Reviews”, Vol. 57,
`No. 9, September 1999: S13-S18.
`
`Porzio et al., “Encapsulation Compositions and Processes for
`Preparing the Same,” U.S. Patent No. 7,488,503 B1 filed
`March 31, 2004 (Porzio).
`
`Bunea, et al., “Evaluation of The Effects Of Neptune Krill Oil On The
`Clinical Course of Hyperlipidemia,” Altern Med Rev. 2004;
`9:420–428 (Bunea).
`
`Complaint filed in Aker Biomarine Antarctic AS v. Olympic
`Holding AS, et al., 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)
`
`
`
`
`
`
`
`
`
`
`
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`1024 Part 1 - Pages 1-450
`1024 Part 2 - Pages 451-900
`1024 Part 3 - Pages 901-1350
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`1025
`
`
`
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`
`
`1024 Part 4 - Pages 1351-1800
`1024 Part 5 - Pages 1801-2250
`1024 Part 6 - Pages 2251-2700
`1024 Part 7 - Pages 2701-3083
`
`U.S. Patent No. 9,078,905
`
`File History to U.S. Patent No. 9,028,877 B2, Serial No, 14/490,176
`(‘877 File History)
`
`
`
`
`
`
`
`
`
`1026
`
`
`
`
`
`
`
`
`
`1027
`
`
`1028
`
`
`1029
`
`
`1030
`
`
`
`
`
`1025 Part 1 - Pages 1-375
`1025 Part 2 - Pages 376-724
`
`File History to U.S. Patent No. 9,078,905 B2, Serial No, 14/490,221
`(‘905 File History)
`
`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)
`
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`1031
`
`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).
`
`
`1032
`
`
`
`
`1033
`
`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).
`
`
`
`
`
`
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`Inter Partes Review Case No.: IPR2017-00745
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`
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`I.
`
`THE PETITION
`
`U.S. Patent No. 9,078,905
`
`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 inter partes review and to find
`
`unpatentable and cancel Claims 1-20 of U.S. Patent No. 9,078,905, entitled
`
`“Bioeffective Krill Oil Compositions,” issued July 14, 2015 (Serial No.
`
`14/490,221, filed September 18, 2014) (“the ‘905 patent”), assigned to Aker
`
`Biomarine Antarctic AS. The ‘905 patent is submitted as Exhibit 1001. There is a
`
`reasonable likelihood that Petitioner will prevail with respect to at least one claim
`
`challenged in this petition.
`
` MANDATORY NOTICES
`II.
`
`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
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`Food and Science Corp., and Petitioner, Rimfrost AS, are identified as the real
`
`U.S. Patent No. 9,078,905
`
`parties-in-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, 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 has been 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, relates to U.S. Patent Nos.
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`9,028,877; 9,078,9051; 9,072,752; 9,320,765; and 9,375,453. The ITC
`
`U.S. Patent No. 9,078,905
`
`investigation lists 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).
`
`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
`
`
`
`1
`Petitioner believes the ‘905 patent is unenforceable due to the filing of an
`improper terminal disclaimer. During prosecution applicants filed a terminal
`disclaimer in an effort to overcome a double patenting rejection based upon
`copending U.S. Application No. 13/856,642. However, U.S. Application No.
`13/856,642 (U.S. Patent No. 9,068,142) was assigned to Rimfrost AS’
`predecessor-in-interest, Olympic Seafood AS. The application for the ‘905 patent
`and U.S. Application No. 13/856,642 were therefore not commonly owned. As a
`result, Complainants in the ITC proceeding moved for partial termination, based
`on withdrawal of the ‘905 claims. The ALJ granted the motion to terminate as to
`the ‘905 patent and a determination of unenforceability was deemed moot.
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`U.S. Patent No. 9,078,905
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`
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`
`
`D.
`
`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
`
`
`Service information (37 C.F.R. §42.8(b)(4))
`
`Service on Petitioner may be made electronically by using the following
`
`email address: 905ipr1@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:
`
`
`
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`
`
`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
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`‘905 patent: Casimir Jones, S.C., 2275 Deming Way, Suite 310, Middleton,
`
`U.S. Patent No. 9,078,905
`
`Wisconsin 53562, and the address of Patent Owner’s litigation counsel: Andrew
`
`F. Pratt, Esq., Venable LLP, 575 Seventh Street NW, Washington, DC 20004.
`
`
`
` PAYMENT OF FEES III.
`
`Pursuant to 37 C.F.R. §§ 42.103 and 42.15(a), the requisite filing fee of
`
`$25,000 (request fee of $9,000, post-institution fee of $14,000 and excess claims
`
`fee of $2,000) for a Petition for Inter Partes Review is submitted herewith.
`
`Claims 1-20 of the ‘905 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 INTER PARTES REVIEW
`IV.
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Petitioner hereby certifies that the ‘905 patent is available for Inter Partes
`
`Review and that Petitioner is not barred or estopped from requesting Inter Partes
`
`Review challenging the claims of ‘905 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 ‘905 patent by
`
`Aker. See, e.g., Exhibits 1021-1022.
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`B.
`
`Level of Ordinary Skill in the Art
`
`U.S. Patent No. 9,078,905
`
`As of the earliest priority date the ‘905 Patent is entitled to, that is January
`
`28, 2008, 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. (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 1-20 are found
`
`unpatentable and cancelled from the ‘905 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 1-20 of the ‘905 patent.
`
`2.
`
`Specific Statutory Grounds on which the
`Challenge is Based (37 C.F.R. § 42.104(b)(2))
`
`The specific statutory grounds for the challenge are as follows:
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`U.S. Patent No. 9,078,905
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`Ground Reference(s)
`
`Basis
`
`Claims Challenged
`
`1
`
`2
`
`3
`
`4
`
`5
`
`Catchpole and Sampalis I
`
`35 U.S.C. §103(a)
`
`1-4 and 9-10
`
`Catchpole, Sampalis I, and
`Randolph
`Catchpole, Sampalis I, and
`Fricke
`Catchpole, Sampalis I,
`Fricke, and Bottino
`Catchpole, Sampalis I, and
`Bottino
`
`35 U.S.C. §103(a) 5
`
`35 U.S.C. §103(a) 6, 12, 15-16, and
`18
`35 U.S.C. §103(a) 7-8, 13-14, 17, and
`19-20
`35 U.S.C. §103(a) 11
`
`Petitioner also relies on the expert declaration of Dr. Stephen Tallon
`
`(Exhibit 1006, hereinafter “Tallon Decl.”).
`
`3.
`
`Earliest Effective Priority Date
`
`The ‘905 patent claims priority to Provisional Application No. 60/920,483,
`
`filed on March 28, 2007, Provisional Application No. 60/975,058, filed on
`
`September 25, 2007, Provisional Application No. 60/983,446, filed on October 29,
`
`2007, and Provisional Application No. 61/024,072, filed on January 28, 2008. All
`
`of the issued claims in the ‘905 patent require the element that the recited krill oil
`
`comprise from about 3% to about 15% w/w or 3% to about 10% w/w ether
`
`phospholipids. Support of the claim element “ether phospholipid” – recited in
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`each ‘905 claim – was not introduced until the filing of U.S. Application No.
`
`U.S. Patent No. 9,078,905
`
`61/024,072 filed on January 28, 2008. (See Exhibits 1002-1005). Consequently,
`
`the earliest effective priority date for the claims of the ‘905 patent is January 28,
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`2008. (Tallon Decl. ¶ 34).
`
`Thus, Aker cannot claim a priority date earlier than January 28, 2008.
`
`4.
`
`Prior Art References
`
`Other than Catchpole, 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 November 1, 2007
`
`and, therefore, qualifies as a prior art reference under 35 U.S.C. § 102(e).2
`
`§ 102(b) Reference
`
`Publication Date
`
`Exhibit No.
`
`Sampalis I
`
`May 2003
`
`Fricke
`
`Bottino
`
`April 30, 1984
`
`June 28, 1974
`
`1012
`
`1010
`
`1007
`
`
`2
`Catchpole also qualifies as a reference pursuant to 35 U.S.C. § 102(a).
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`Inter Partes Review Case No.: IPR2017-00745
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`U.S. Patent No. 9,078,905
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`§ 102(b) Reference
`
`Publication Date
`
`Exhibit No.
`
`Randolph
`
`March 17, 2005
`
`1011
`
`
`
`§ 102(e) Reference
`
`Publication Date
`
`Exhibit No.
`
`Catchpole
`
`November 1, 2007
`
`1009
`
`
`
`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).
`
`The following discussion proposes constructions of terms in the challenged
`
`claims under the broadest reasonable construction standard. Any claim terms not
`
`included in the following discussion are to be given their broadest reasonable
`
`interpretation (BRI) in light of the specification as commonly understood by those
`
`of ordinary skill in the art. (M.P.E.P. § 2111.01(I)). Should the patent owner, in
`
`order to avoid the prior art, contend that the claims have a construction different
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`Inter Partes Review Case No.: IPR2017-00745
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`from their BRI, the appropriate course is for the patent owner to seek to amend the
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`U.S. Patent No. 9,078,905
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`claims to expressly correspond to its contentions in this proceeding. See 77 Fed.
`
`Reg. 48764 (Aug. 14, 2012). Any such amendment would only be permissible if
`
`the proposed amended claims comply with 35 U.S.C. § 112.
`
`Also, for the applicants of the ‘905 patent to act as their own lexicographer,
`
`the definition of a claim term must be set forth in the specification with reasonable
`
`clarity, deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
`
`Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998). If a limitation is not necessary to
`
`give meaning to what the ‘905 patent inventors mean by a claim term, it would be
`
`“extraneous” and should not be read into the claim. Renishaw, 158 F.3d at 1249;
`
`E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1433
`
`(Fed. Cir. 1988). The construction that stays true to the claim language and most
`
`naturally aligns with the inventors’ description is likely the correct interpretation.
`
`See Renishaw, 158 F.3d at 1250.
`
`Petitioner’s position regarding the scope of the ‘905 patent claims should
`
`not be taken as an admission of the proper claim scope in other adjudicative
`
`forums where a different claim interpretation standard may apply, e.g., in a patent
`
`infringement action. Moreover, Petitioner reserves all of its rights to further
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`Inter Partes Review Case No.: IPR2017-00745
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`challenge any claim terms of the ‘905 patent under 35 U.S.C. § 112, including by
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`U.S. Patent No. 9,078,905
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`arguing that the terms are not definite, not supported by the written description,
`
`and/or not enabled. Further, as Petitioner is precluded from presenting challenges
`
`under 35 U.S.C. § 112 in an inter partes review, Petitioner’s arguments in this
`
`Petition, or lack of arguments on any of these grounds, should not be interpreted
`
`as waiving or conflicting with invalidity arguments in other forums under 35
`
`U.S.C. § 112.
`
`The claim construction in a district court litigation or ITC proceeding can be
`
`narrower than in an inter partes review because it is performed in view of both the
`
`intrinsic and extrinsic record and is the meaning that the term would have to a
`
`person of ordinary skill in the art in question at the time of the invention, i.e., as of
`
`the effective filing date of the application. Phillips v. AWH Corp., 415 F.3d 1303,
`
`1313 (Fed. Cir. 2005). This construction may be narrower than the BRI. In
`
`addition, if the claim is still ambiguous in view of the relevant evidence during
`
`litigation, it should be construed to preserve the validity. Id. at 1327.
`
`This standard does not apply to inter partes review. For purposes of inter
`
`partes review, each challenged claim must be given “its broadest reasonable
`
`constructions in light of the specification.” 37 C.F.R. § 42.100(b); see also Cuozzo
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`Inter Partes Review Case No.: IPR2017-00745
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`Speed Technologies. LLC v. Lee, 136 S. Ct. 2131, 2142 (2016); see also In re
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`U.S. Patent No. 9,078,905
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`Cuozzo Speed Techs., LLC, 778 F. 3d 1271, 1279 (Fed. Cir. 2015). The BRI must
`
`be consistent with the construction that one of ordinary skill in the art would reach
`
`and must take into account any special definition given to a claim term in the
`
`specification. In re Am. Acad. Of Sci. Tech. Ctr., 367 F. 3d 1359, 1364 (Fed. Cir.
`
`2004). Thus, solely for this proceeding, Petitioner’s proposed constructions are set
`
`forth below. See infra, pp. 19-26. All other terms, not expressly discussed, should
`
`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 ‘905 PATENT (EXHIBIT 1001)
`
`A. Background of ‘905 Patent
`
`The ‘905 patent relates to extracts from Antarctic krill that includes
`
`bioactive fatty acids. (Exhibit 1001, p. 0025, col. 1, lines 19-20). In the Detailed
`
`Description of the Invention, the patentees of the ‘905 patent state, “[t]his
`
`invention discloses novel krill oil compositions characterized by containing high
`
`levels of astaxanthin, phospholipids, included an enriched qualities of ether
`
`phospholipids, and omega-3 fatty acids.” (Exhibit 1001, p. 0029, col. 9, lines 28-
`
`28-31).
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`U.S. Patent No. 9,078,905
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`However, as acknowledged in the Background of the Invention, “a krill oil
`
`composition has been disclosed comprising a phospholipid and/or a flavonoid.
`
`The phospholipid content and 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, p. 0025, col. 1, lines 53-57). Patentees also acknowledged that krill
`
`oil compositions have been described as being effective for decreasing cholesterol,
`
`inhibiting platelet adhesion, inhibiting artery plaque formation, preventing
`
`hypertension, controlling arthritis symptoms, preventing skin cancer, enhancing
`
`transdermal transport, reducing the symptoms of premenstrual symptoms or
`
`controlling blood glucose levels in a patient. Citing, e.g., WO 02/102394 (Exhibit
`
`1001, p. 0025 col. 1, lines 46-52). Patentees also admit, “[s]upercritical fluid
`
`extraction with solvent modifier has previously been used to extract marine
`
`phospholipids from salmon roe, but has not been previously used to extract
`
`phospholipids from krill meal. See, e.g., Tanaka et al., J. Oleo. Sci. (2004), 53(9),
`
`417-424.” (Exhibit 1001, p. 0025, col. 1, line 65 to col. 2, line 2).
`
`The analysis of the krill oil preparation disclosed in the ‘905 patent is
`
`provided in Table 21, which shows the amount of phospholipids, triglycerides, and
`
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`Inter Partes Review Case No.: IPR2017-00745
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`omega-3 fatty acids in the extract. Tables 22 and 23 provide the only ether
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`U.S. Patent No. 9,078,905
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`phospholipid data in the entire specification. Example 8 concludes:
`
`The main polar ether phospholipids 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.
`
`(Exhibit 1001, p. 0041, col. 33, lines 9-14). (Tallon Decl. ¶184).
`
`All issued claims recite the ether phospholipid limitation, which is the
`
`element that patentees rely upon for novelty. However, as demonstrated herein, it
`
`would have been obvious to a POSITA to encapsulate a krill oil having between 3
`
`and 10% w/w of ether phospholipids.
`
`B.
`
`Prosecution History of the ‘905 Patent
`
`The ‘905 patent issued on July 14, 2015 from U.S. Application No.
`
`14/490,221 filed September 18, 2014. The ‘905 patent is a continuation of U.S.
`
`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.
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`U.S. Patent No. 9,078,905
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`All of the claims of the ‘905 patent recite the claim limitation of “about 3%
`
`to about 15% w/w ether phospholipids” or “about 3% to about 10% w/w ether
`
`phospholipids.” Applicants relied on this limitation in asserting patentability of
`
`the claims.
`
`In parent U.S. Application no. 12/057,775, which granted as U.S. Patent No.
`
`9,034,388, Applicants 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. (Exhibit 1024, part 2, pp. 0633 - 0650). 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, p. 0640).
`
`In the ‘221 application which issued as the ‘905 patent, a Non-Final Office
`
`Action was mailed November 17, 2014 (Exhibit 1026, part 2, pp. 0622 - 0631) that
`
`rejected all the as-filed claims. In addition to several non-statutory double
`
`patenting rejections, 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 et al. was
`
`characterized as disclosing krill oil components including phospholipids and
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`Inter Partes Review Case No.: IPR2017-00745
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`triglycerides at similar concentrations as presented in the claims. This was
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`U.S. Patent No. 9,078,905
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`combined with Porzio, which teaches how to encapsulate lipid compositions.
`
`
`
`A Response to the Non-Final Office Action was filed on December 19, 2014
`
`with no claim amendments. In an effort to distinguish the cited art, applicants
`
`maintained that the prior art did not disclose a krill oil comprising “from about 3%
`
`- 15% ether phospholipids.” It was argued that Beaudoin’s ‘299 patent extraction
`
`method was virtually identical to the NKO (Neptune Krill Oil) extraction process
`
`and would therefore would purportedly contain less than 3% ether phospholipids.
`
`An analysis was presented of the NKO composition in the ‘905 patent
`
`(Example 8 and Table 22), showing that NKO has 7% AAPC and 1.2% LAAPC,
`
`i.e., a total ether phospholipid content of 8.2% of total phospholipids. It was
`
`argued that this percentage corresponded to an actual 2.46% value3 when relative
`
`to the krill oil (e.g., based upon a 30% measurement of total NKO phospholipids).
`
`It was argued, “[a]pplicant respectfully submits that this demonstrates that krill oil
`
`made by the Beaudoin method does not contain the claimed range of 3% to 15%
`
`
`3
`This is an admission that Beaudoin et al. describes krill oil having just
`below 3% ether phospholipids.
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`Inter Partes Review Case No.: IPR2017-00745
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`ether phospholipids as a percentage of the total krill oil composition.” (Exhibit
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`U.S. Patent No. 9,078,905
`
`1026, part 1 pp. 0242 - 0251).
`
`A Final Rejection was mailed on February 17, 2015 (Exhibit 1026, part 1,
`
`pp. 0168 - 0177) where the non-statutory double patenting and obviousness
`
`rejections were maintained. The Examiner asserted that the calculated 2.46%
`
`ether phospholipid concentration in Beaudoin et al. was close enough to the
`
`claimed range such that it would be obvious for one of ordinary skill in the art to
`
`optimize the extraction process through routine means to increase the ether
`
`phospholipid content to the claimed 3% concentration because of the known
`
`hea
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