PUBLIC VERSION
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
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`Washington, D.C.
`
`
`In the Matter of
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`CERTAIN KRILL OIL PRODUCTS AND
`KRILL MEAL FOR PRODUCTION OF
`KRILL OIL PRODUCTS
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`“
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`Inv. No. 337-TA-1019
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`ORDERNO.13:
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`MARKMAN ORDER
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`(April 13, 2017)
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`A Markman hearing washeld in this investigation on March 2, 2017. Counsel for
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`Complainants Aker BioMarine Antarctic AS and Aker BioMarine Manufacturing, LLC and
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`Respondents Olympic Holding AS, Rimfrost AS, Emerald Fisheries AS, Avoca,Inc., Rimfrost
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`USA, LLC, Rimfrost New ZealandLimited, and Bioriginal Food & Science Corp. appeared at
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`the hearing. In advance of the hearing, Complainants and Respondentsfiled initial and rebuttal
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`Markmanbriefs.'*
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`' Complainantsfiled a correctedinitial brief pursuant to Order No. 9 (Feb. 10, 2017).
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`2 Complainants’ initial and rebuttal briefs are referenced herein as “CIB” and “CRB,” and
`Respondents’ initial and rebuttal briefs are referenced herein as “RIB” and “RRB.”
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`Table of Contents
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`PROCEDURAL HISTORY.....0....ecccecscceseesseeersseneeesesecceeeenecseseeestsssseesscsessaeesecseesessesseee 1
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`LEGAL STANDARD 2000... ccececcseteeseeeeeeeeeeeseeneeesceaecseceeeesersecssssecesseseesasessenesseessesseeed 1
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`ASSERTEDPATENTS........cccccececceceeeeesseeneeeceesceseessesecseessecsessucaeesesessnesacssseseensesasenesaeee 3
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`LEVEL OF ORDINARYSKILL IN THE ART0...cece ene ceeeeeeeeeeeeteeneeesees 4
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`DISPUTED TERMS 0.0.0... eceeceeceeeecneeneeneceseseaseeeesseesseassessusesecseeeessecseeseesseseesaeeneseeeesees 5
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`SHH OF? ooo eee cece cescceteeeeeceeceseesecssecesecseceseeesesaeensesssesssessecssesesesesesesesecssecsuesseeseesaeeeseseas 5
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`“polar Krill Of”...eeesevvsssssensseseeeseeeeteesteseennnsensnesesnsvenensnesnentsetetes 10
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`“krill” and “Euphausia superba”... siete ieee eee eeeneseseseseseseeeeeeeeneees 15
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`“denatured krill product”.........0.. ccc cee secsceseseessceeneeesseseesceesaceseessesesseeeesasensaeeseseesaees 16
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`“Sastaxamthin” oo... eecceececeseeceeeesecceseceeaeerseesessceseceeseesessasseeessseeseesseesseensseeessseesesenesenseess 18
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`CONCLUSION 0... ccccccccccccceseeseecceeeseeeeeseseecneseeesaeessesessecsaessesesessessessasseesesseseesessansenseseenees 26
`
`il
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`-I.
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`PROCEDURAL HISTORY
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`This investigation was instituted to determine whetherthere is a violation ofsection 337
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`of the Tariff Act of 1930, as amended,in the importation into the United States, the sale for
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`importation, or the sale within the United States after importation of certain krill oil products and
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`krill meal for production of krill oil products by reason of infringementof certain claims of U.S.
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`Patent No. 9,028,877 (the “’877 patent”); U.S. Patent No. 9,078,905 (the “’905 patent’); U.S.
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`Patent No. 9,072,752 (the “’752 patent”); U.S. Patent No. 9,320,765 (the “’765 patent’’); and
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`U.S. Patent No. 9,375,453 (the “453 patent”). Notice of Investigation, 81 Fed. Reg. 63805-06
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`(2016). Pursuant to Order No. 5, the 905 patent was withdrawn from the investigation. Order
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`No. 5 (Oct. 17, 2016), not reviewed by Comm’n Notice (Nov.7, 2016).
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`The asserted claims in the four remaining patents are claims 1-4, 7-9, 11-13, and 16-18 of
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`the ’877 patent; claims 1, 7, and 11-13 of the °752 patent; claims 1-5, 7, 9-12, 14-15, 19-21, 23,
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`25-29, 31, 33-36, 38-39, 43-45, and 47 of the ’765 patent; and claims 1, 5-10, 12, 14-17, 19-20,
`24-26, 28, 30-32, 33-36, 39-43, 46-49, 51-52, 56-58, and 60 ofthe °453 patent. All ofthe
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`asserted patents claim priority to the same parent application and share a commonspecification.
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`The parties’ Markmanbriefing addresses six disputed claim terms, each of which appears in the
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`claimsof several of the asserted patents.
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`Wl.
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`LEGAL STANDARD
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`“The construction of claims is simply a way of elaborating the normally terse claim
`language[] in order to understand and explain, but not to change, the scope of the claims.”
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`Embrex, Inc. v. Serv. Eng’g Corp., 216 F.3d 1343, 1347 (Fed. Cir. 2000) (alterations in original)
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`(quoting Scripps Clinic v. Genentech, Inc., 927 F.2d 1565, 1580 (Fed. Cir. 1991)). “[O]nly those
`[claim] terms need be construed that are in controversy, and only to the extent necessary to
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`resolve the controversy.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed.
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`Cir. 1999).
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`Claim construction focuses mainly on the intrinsic evidence, which consists of the claims
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`themselves, the specification, and the prosecution history. See generally Phillips v. AWH Corp.,
`415 3d 1303 (Fed. Cir. 2005) (en banc). The Federal Circuit in Phillips explained that, in
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`construing terms, courts must analyze each of these components to determine the “ordinary and
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`customary meaning of a claim term,” whichis “the meaning that the term would have to a person
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`of ordinary skill in the art in question at the time of the invention.” Jd. at 1313.
`“Jt is a ‘bedrock principle’ ofpatent lawthat ‘the claims ofa patent define the invention
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`to which the patenteeis entitled the right to exclude.’” Jd. at 1312. “Quite apart from the written
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`description and the prosecution history, the claims themselves provide substantial guidanceas to
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`the meaningofparticular claim terms.” /d. at 1314. For example, “the context in which a term
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`is used in the asserted claim can be highly instructive,” and “[o]ther claims of the patent in
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`question, both asserted and unasserted, can also be valuable sources of enlightenmentas to the
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`meaning of a claim term.” Jd.
`“T]he specification ‘is always highly relevant to the claim construction analysis.
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`Usually, it is dispositive;it is the single best guide to the meaning of a disputed term.’” Jd. at
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`1315 (quoting Vitronics Corp. v. Conceptronic, 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “The
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`longstanding difficulty is the contrasting nature of the axiomsthat (a) a claim mustbe read in
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`view ofthe specification and (b) a court maynotread a limitation into a claim from the
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`specification.” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111,
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`1117 (Fed. Cir. 2004). The Federal Circuit has explained that there are certain instances when
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`the specification may limit the meaning of the claim language. For example,“the specification
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`may reveal a special definition given to a claim term by the patentee that differs from the
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`meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”
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`Phillips, 415 F.3d at 1316. The specification also “may reveal an intentional disclaimer, or
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`disavowal, of claim scope by the inventor.” Jd.
`In such cases,“the inventorhasdictated the
`correct claim scope, and the inventor’s intention, as expressed in the specification, is regarded as
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`dispositive.” Id.
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`In addition to the claims and the specification, the prosecution history should be
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`examined if in evidence. “The prosecution history .
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`.
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`. consists of the complete record of the
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`proceedings before the PTO and includes the prior art cited during the examination ofthe patent.
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`Like the specification, the prosecution history provides evidence of how the PTO andthe
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`inventor understoodthe patent.” Jd. at 1317. “[T]he prosecution history can often inform the
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`meaningof the claim language by demonstrating how the inventor understood the invention and
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`whether the inventor limited the invention in the course of prosecution, making the claim scope
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`narrower than it would otherwise be.” Jd.
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`If the intrinsic evidence does not establish the meaning of a claim, then extrinsic evidence
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`may be considered. Extrinsic evidence “consists of all evidence external to the patent and the
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`prosecution history, including inventor and expert testimony, dictionaries, and learnedtreatises.”
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`Id. at 1317. Extrinsic evidenceis generally viewed “as less reliable than the patent andits
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`prosecution history in determining how to read claim terms.” /d. at 1318. “The court may
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`receive extrinsic evidence to educate itself about the invention and the relevant technology, but
`the court may not use extrinsic evidence to arrive at a claim construction thatis clearly at odds |
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`with the construction mandated by the intrinsic evidence.” Elkay Mfg. Co. v. Ebco Mfg. Co., 192
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`F.3d 973, 977 (Fed. Cir. 1999).
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`UI. ASSERTED PATENTS
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`The four asserted patents claim priority to the same parent application and share a
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`common specification. The parent application, U.S. Patent Application No. 12/057,775, was
`filed on March 28, 2008, naming inventors Inge Bruheim, Snorre Tilseth, and Daniele
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`Mancinelli of Aker Biomarine Antarctic AS. The ’877 patent, entitled “Bioeffective Krill Oil
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`Compositions,” issued on May 12, 2015, with two independent claims for methods of production
`of krill oil. The °453 patent, entitled “Methods for Producing Bioeffective Krill Oil
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`Compositions,” issued on June 28, 2016, with two independent claims for methods of production
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`ofpolar krill oil. The ’752 patent, entitled “Bioeffective Krill Oil Compositions,” issued on July
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`7, 2015, with two independentclaims for specific compositionsofkrill oil. The ’765 patent, also
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`entitled “Bioeffective Krill Oil Compositions,” issued on April 26, 2016, with two independent
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`claims for specific compositions of krill oil.
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`The common specification of the asserted patents describes the extraction ofkrill oil from
`Antarctic krill. In the prior art, frozen krill was transported over long distances for processing.
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`’877 patent at 2:3-16. The patents describe the downsidesofthis transportation, which “is both
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`expensive and can result in degradation of the krill starting material.” Jd. at 2:5-6. To avoid
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`these problems, the patents describe a process wherekrill meal is “processed on board a ship in
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`Antarctica using live krill as starting material.” Jd. at 9:33-36. This processing includes a
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`“protein denaturation step” followed by the extraction ofkrill oil. Id. at 9:48-54. This extraction
`can proceed in two stages, with the neutral lipids being extracted in the first stage and the polar
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`lipids being extracted in the second stage. Jd. at 9:36-42. The result of the processis krill oil
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`“characterized by containing high levels of astaxanthin, phospholipids, includ[ing] enriched
`quantities ofether phospholipids and omega-3 fatty acids.” Jd. at 9:28-31.
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`|
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`IV. LEVEL OF ORDINARY SKILL IN THE ART
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`Complainants contend that a person of ordinary skill in the relevant art would have a
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`Bachelor’s degree in chemical engineering, chemistry, biology, or food science, plus 1-3 years’
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`experience related to the analysis of organic compounds. CIB at 15. Respondents contend that a
`person of ordinary skill in the art would have held an advanced degree in a relevant scientific
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`field,? knowledge of or experience in the field of extraction, and atleast five years’ post-graduate
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`experience. RIB at 11. Although Respondents propose a more advancedstandard for ordinary
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`skill in the art, this dispute betweenthe parties does notaffect the construction of any ofthe
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`disputed terms, andit is not resolvedat this time.
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`V. DISPUTED TERMS
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`Theparties briefed six disputed terms from the asserted patents, andfive of these terms
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`remain disputed.*
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`A. “krill oil”
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`The term “krill oil” appears in all of the asserted independent claims.
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` Respondentsa@onstruction
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`“krilloil”
`oil virtually free of
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`enzymatically decomposedoil
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`constituents that are obtained
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`from krill following protein
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`denaturation
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`Complainants proposethat this term has its plain and ordinary meaning. In
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`Complainants’ view, the patents use the term “krill oil” in accordance with its plain and ordinary
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`meaning, and there is no definition or disclaimer in the specification. CIB at 16-18.
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`> Respondents identify marine sciences, biochemistry, organic (especially lipid) chemistry,
`nutritional sciences, chemical or process engineering, or associated sciences with complementary
`understanding, either through education or experience, of biochemistry, organic chemistry and in
`particular lipid chemistry, nutrition, chemical or process engineering, marine biology,or
`associated sciences. RIB at 11.
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`* Theparties previously disputed the terms“freshly harvested” and “freshly caught,” but during
`the Markman hearing, the parties agreed that the claim languageitself was more clear than any
`of the parties’ proposed constructions, and accordingly, no construction is adopted at this time.
`Tr. at 115:21-116:19.
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`Respondents base their proposed construction on a description of the invention in the
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`specification, pointing to the second paragraph of the “Detailed Description of the Invention,”
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`whichstates:
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`The present invention provides methods to avoid decomposition of
`glycerides and phospholipidsin krill oil and compositions
`produced by those methods. The product obtained by these new
`methodsis virtually free of enzymatically decomposedoil
`constituents. The solution to the problem is to incorporate a
`protein denaturation step on fresh krill prior to use of any
`extraction technology. Denaturation can be achieved by thermal
`stress or by other means .... Surprisingly, it has been found that
`the use of mild denaturation conditions can greatly enhance the
`quality of krill oil.
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`°877 patent at 9:43-60. Respondents argue that this description of the “present invention” limits
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`the claimsto krill oil that is virtually free of enzymatically decomposedoil constituents that are
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`obtained from krill following protein denaturation. RIB at 12-16; RRB at 1-7. Respondents
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`argue that the specification consistently distinguishes the claimedkrill oil from the priorart that
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`contained decomposed phospholipids. RIB at 15 (citing ’877 patent at 10:51-64).
`I agree with Complainants that the term “krill oil” in the asserted patents has its plain and
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`ordinary meaning, which is oil produced from krill. See Phillips, 415 F.3d at 1313 ([T]he
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`words of a claim are generally given their ordinary and customary meaning.”). The specification |
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`uses the term “krill oil” generally, to refer to both the prior art and the claimed invention. See,
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`e.g., °877 patent at 1:31-32 (“In orderto isolate the krill oil from the krill, solvent extraction
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`methods have been used.”), 1:46-52 (“Krill oil compositions have been described as being
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`effective for decreasing cholesterol. .
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`. .”), 9:43-45 (“The present invention provides methodsto
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`avoid decomposition of glycerides and phospholipids in krill oil and compositions produced by
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`those methods.”), 9:58-60 (“Surprisingly, it has been found that the use of mild denaturation
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`conditions can greatly enhancethe quality of krill oil.”). There is no indicationthat the patentee
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`acted as his own lexicographer when usingthe term “krill oil” or disclaimed the full scope of the
`term “krill oil” in the specification or during prosecution. “See Thornerv. Sony Computer
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`Entertainment America LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).
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`At the Markmanhearing, Respondentscited case law emphasizing the importance of —
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`patent language referencing the “present invention,” but the Federal Circuit has held that such
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`language“is not always so limiting, such as wherethe referencesto a certain limitation as being
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`the ‘invention’ are not uniform, or where other portionsofthe intrinsic evidence do not support
`applying the limitation to the entire patent.” Absolute Software, Inc. v. Stealth Signal, Inc., 659
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`F.3d 1121, 1136-37 (Fed. Cir. 2011). That is the case here, where the paragraph referencing
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`~ decomposedoil constituents is only one of many descriptionsof the “invention” and the “present
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`invention”in the specification. When these statements are read in the context of the entire
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`specification, it is clear that avoiding decomposition is only one of many benefits of the
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`invention. It would be inappropriate to read such a limitation into every claim that uses the term
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`“Krill oil.”
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`Respondents’ arguments focus on the description of the “present invention” in the second
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`paragraph ofthe “Detailed Description of the Invention,” but the preceding paragraph
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`emphasizes different features of the invention: “This invention discloses novel krill oil
`compositions characterized by containing high levels of astaxanthin, phospholipids, included
`[sic] an enriched quantities of ether phospholipids, and omega-3 fatty acids.” °877 patentat
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`9:28-31. These componentsofthe claimedkrill oil are consistently referenced more prominently
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`in the specification than the decomposedoil constituents cited by Respondents, appearing in the
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`first sentence of the Abstract and the first several paragraphs of the “Summary of the Invention.
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`See id. at Abstract (“This invention discloses new krill oil compositions characterized by having
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`high amounts of phospholipids, astaxanthin esters and/or omega-3 contents.”), 2:20-41
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`(describing levels of phospholipids, omega-3 fatty acids, and astaxanthin esters). Notably, these
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`limitations regarding the amountof phospholipids, astaxanthin esters, and/ortriglycerides are
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`explicitly claimed in the independentclaimsof the asserted patents. See, e.g., *765 patent at
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`claim 1, 34:64-35:5 (“A krill oil composition comprising Euphausia superba krill oil suitable for
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`oral administration, said krill oil comprising greater than about 3% ether phospholipids w/w of
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`said krill oil; from about 27% to 50% non-ether phospholipids w/w ofsaid krill oil so that the
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`amountof total phospholipids in the composition is from about 30% to 60% w/w ofsaid krill oil;
`from about 20% to 50% triglycerides w/w of said krill oil, and astaxanthin esters in amount of
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`greater than about 100 mg/kg of said krill oil.”).° Whenread in the contextof these other
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`statements in the specification and the claims, the avoidance of decomposedoil constituents is at
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`best a secondary feature of the invention.
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`Respondents’ arguments regarding the significance of the “present invention” language
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`are undercut by the numerousinstancesof this phrase in the specification. In the “Summary of
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`theInvention,” the phrase “the present invention” is invoked more than forty times, describing
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`different aspects of the invention suchas the health benefits, phospholipid content, astaxanthin
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`levels, species of krill, capsule form, fat content, extraction steps, and methods for administering
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`> See also ’877 patentat claim 1, 34:64-35:2 (“a krill oil with from about 3% to about 10% w/w
`ether phospholipids; from about 27% to 50% w/w non-ether phospholipids so that the amount of -
`total phospholipidsin said krill oil is from about 30% to 60% w/w; and about 20% to 50% w/w
`triglycerides”); °453 patent at claim 1, 35:48-56 (“a polarkrill oil comprising phospholipids, said
`polarkrill oil comprises greater than about3% ether phospholipids w/w ofsaid polar krill oil;
`from about 27% to 50% non-ether phospholipids w/w ofsaid polarkrill oil so that the amount of
`total phospholipids is from about 30% to 60% w/w ofsaid polar krill oil; from about 20% to 50%
`triglycerides w/w ofsaid polarkrill oil, and astaxanthin esters in amount of greater than about
`~ 100 mg/kgofsaid polar krill oil”); ’752 patent at claim 1, 34:65-67 (“A polar krill oil comprising
`greater than about 40% phosphatidylcholine w/w of said krill oil and greater than about 5% ether
`phospholipids w/w ofsaid krill oil.”).
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`krill oil. °877 patent at 2:42-7:52. The “Detailed Description of the Present Invention” similarly
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`includes more than thirty references to the “present invention,” describing the same variety of
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`benefits, processing steps, and specific contents of the krill oil. Jd. at 9:43-14:46. Respondents
`have failed to make a compelling argument for importing a “decomposed oil constituents”
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`limitation into the claims while ignoring the manyother features of the “present invention”
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`referenced in the specification. Providing higher phospholipid content, avoiding decomposition,
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`and improving health outcomes mayall be important benefitsof the invented krill oil, but the
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`Federal Circuit has warnedthat “not every benefit flowing from an invention is a claim
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`limitation.” i4i Ltd. P'ship v. Microsoft Corp., 598 F.3d 831, 843 (Fed. Cir. 2010), affd, 564
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`U.S. 91 (2011).
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`Other claim languagein the asserted patents further counsels against the incorporation of
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`Respondents’ proposed limitation into the construction for “krill oil.” In the method claims, there
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`is an explicit denaturation step, which is the patent’s claimed solution to the problem of
`decomposition. Compare ’877 patent at 9:48-50 (“The solution to the problem is to incorporate
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`a protein denaturation step on fresh krill prior to use of any extraction technology.”) with id. at
`claim 1, 34:61-62 (“treating said krill to denature lipases and phospholipasesin said krill to
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`provide a denaturedkrill product”); see also ’453 patent at claim 1, 35:45-46 (“treating the
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`Euphausia superba to denature lipases and phospholipases to provide a denaturedkrill product”).
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`The patenteesare entitled to claim this feature by reference to a denaturation step rather than by
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`specifying the content of decomposedoil constituents. See Phillips, 415 F.3d at 1312 (“It isa
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`‘bedrock principle’ of patent law that “the claimsof a patent define the invention to which the
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`patenteeis entitled the right to exclude.””) (quoting Jmnova, 381 F.3d at 1115).
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`In addition, there are unasserted dependent claims with explicit limitations on the
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`proportion of attached fatty acids, whichrelates to the feature of avoiding decomposition.
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`Dependent claims 5 and 14 of the ’877 patent, claims 11, 18, 27, 44, and 59 of the *453 patent,
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`and claims 6, 13, 22, 30, 37, and 40 of the ’765 patent claim percentagesof attached fatty acids.
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`See, e.g., ?877 patent at claim 5, 35:10-12 (“wherein from about 70% to 95% of said omega-3
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`fatty acids are attachedto said total phospholipids”); ’453 patent at claim 27 (“wherein from
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`about 70% to 95% of said omega-3 fatty acids are attached to said total phospholipids’); °765
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`patentat claim 13 (“wherein from about 70% to 95% of said omega-3 fatty acids are attached to
`said total phospholipids”). Byrequiring a high percentage of attached fatty acids, these
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`limitationslimit the percentage of unattached “free” fatty acids, which is the limitation that
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`Respondents propose to incorporate into their construction. Thepresenceofthis limitation in
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`dependentclaims “gives rise to a presumption that the limitation in question is not presentin the
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`independent claim.” Phillips, 415 F.3d at 1315. The language of the dependentclaims thus
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`further counsels against the adoption of Respondents’ proposed construction.
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`Whenthe patent claims and specification are read as a whole,it is clear that the term
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`“krill oil” is used in accordance with its plain and ordinary meaning, and it would be
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`inappropriate to import Respondents’ proposed limitation into this claim term.
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`B. “polar krill oil”
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`The term “polar krill oil” appears in the asserted claimsof the °453 and °752 patents.
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`
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`cr [CripainantsZeonstructionl Respondents<Constructionm
`“polar krill oil” krill oil containing polar lipids|krill oil containing polar lipids
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`obtained from supercritical
`extraction with polar entrainer
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`° As described during the tutorial, one of the advantagesofkrill is that the fatty acids are
`“attached” to phospholipids, and a problem that the invention wastrying to solveis that these
`fatty acids detach and become“free” in the decomposition process. Tutorial Tr. at 36-37; 877
`patent at 2:3-13.
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`The parties agree that the specification uses the term “polar krill oil” to refer to krill oil
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`containing polar lipids, pointing to Example 3 of the specification. CIB at 19-20; RIB at 16-17
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`(citing ’453 patent at 21:64-22:14). Complainants contendthatit is sufficient to construe polar
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`krill oil as “krill oil containing polar lipids,” but Respondents argue that construction of this term
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`requires a limitation on how thekrill oil is extracted—specifying that polar krill oil must be
`“obtained from supercritical extraction with polar entrainer.””
`The embodiment in Example 3 ofthe specification is consistent with both Complainants’
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`and Respondents’ proposed constructions. This embodiment describes a method for extracting
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`krill oil using “‘a supercritical fluid extraction method in twostages.” °453 patent at 21:64-65. In
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`the first stage, “neutral krill oil” is removed using carbon dioxide. Jd. at 21:65-67. In the second
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`stage, ethanolis added, and the specification states: “This resulted in further extraction of 9%
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`polar fat which hereafter is called polar krill oil.” Zd. at 22:2-3. The specification further
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`provides several tables describing the contents of the neutral krill oil and the polar krill oil in
`comparisonto prior art krill oil. Jd. at 22:15-27:60. The term “polar krill oil” is also referenced
`earlier in the specification, including a statement that “[i]n some embodiments,the supercritical
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`fluid extraction uses carbon dioxide with the addition of a polar entrainer, such as ethanol, to
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`producea polarkrill oil.” *453 patent at 11:10-14. In anotherpart ofthe specification,there is
`an embodimentof“extracting a polar krill oil from said deodorized krill material by supercritical
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`fluid extraction with a polar entrainer to provide an essentially odorless krill oil.” Jd. at 5:22-25.
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`Respondents argue that the specification consistently describes the extraction of polar krill oil
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`using supercritical fluid extraction with ethanol, a polar entrainer, and that these limitations must
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`’ The claim languagein the ’453 patent uses the term “polar solvent,” ’453 patent at 35:47-48,
`and Respondents confirmedthat there is no difference between a “polar entrainer” and a “polar
`solvent.” Markman Tr. at 57:18-24.
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`be imported into the construction for “polar krill oil.” RIB at 16-18.
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`In the context of Example 3, Respondents argue that the specification distinguishespolar .
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`krill oil from neutral krill oil by combining the use of supercritical fluid extraction and polar
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`entrainer (ethanol). RRB.at 7-10. Supercritical fluid extraction is used for both neutral krill oil
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`and polar krill oil.
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`’453 patent at 21:64-22:14. Respondents are correct that in Example 3,
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`ethanolis not used for the extraction of neutral krill oil but only for polar krill oil. d. at 21:65-
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`22:3. The use of ethanol is only one of manydistinctions between these two typesof krill oil
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`described in Example 3, however, which includes eight detailed tables showing differences in the
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`contents of neutral krill oil and polar krill oil. Jd. at 22:3-27:60. In addition, Example 3
`describes differences in the pressure and length oftime for the extraction ofneutral krill oil and
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`polar krill oil. Compareid. at 21:65-67 (“During stage 1, 12.1% fat (neutral krill oil) was
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`removed using neat CO2 only at 300 bars, 60° C, and for 30 minutes.”) fo id. at 21:67-22:2 (“In
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`stage 2, the pressure was increased to 400 bar and 20% ethanol was added (v/v) for 90
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`minutes.”). The specification also indicatesthat the order of the steps is important, with neutral
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`lipids extracted in the first stage and polar lipids further extracted in the second stage. Id. at
`21:64-22:3 (“This resulted infurther extraction of9% polar fat which hereafter is called polar
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`krill oil.” (emphasis added)); see also id. at 11:7-8 (“In other embodiments,the krill oil is
`extracted by one or two step supercritical fluid extraction.”). There is nothing in the
`specification to suggest that Respondents’ two proposed limitations, supercritical fluid extraction
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`and polar entrainer, are the definingfeatures ofpolarkrill oil in the asserted patents.
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`Respondents have not identified any definitions or disclaimersin the specification, and these two
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`features of polar krill oil do not appear to be any more significant than other aspects ofthe
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`embodiments described in the specification.
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`Anotherpart ofthe specification provides intrinsic evidence that contradicts
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`Respondents’ proposed construction: In Example 7, neutral lipids are extracted using
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`supercritical fluid extraction with a polar entrainer. °453 patent at 31:44-54. In Example 7, both
`stages ofa two-stage extraction process are performed “using supercritical fluid extraction with
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`co-solvent.” Jd. at 31:44-45. This includesa first extraction stage using 5% ethanol to “remove
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`neutral lipids and astaxanthin from the krill meal,” and a second stage where “the ethanol content
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`was increased to 23%.” Jd. at 31:44-54. This embodimentis referenced in anotherpart of the
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`specification,stating: ’Surprisingly, it has been found that use of a low amountofpolar solvent
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`in the CO, as an entrainer facilitates the extraction of neutral lipid components and astaxanthin in
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`a single step.” Jd. at 11:24-27. Whenthe specification is read as a whole, there is no consistent
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`definition of polar krill oil that comports with Respondents’ proposed construction.
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`Respondents argue that adopting Complainants’ construction without any additional
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`limitations would remove any distinction between the claimed polar krill oil and other krill oil,
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`RRB at 7-10, but this ignores the other limitations in the asserted claims. The claim language of
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`the °453 patent and ’752 patent explicitly incorporates other limitations that distinguish polar
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`‘krill oil from otherkrilloil. Independent claims 1 and 33 of the ’453 patent require the use of “a
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`polar solvent to extract polar krill oil” and “astaxanthin esters in amount of greater than about
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`100 mg/kg of said polar krill oil.” ’453 patent at 35:47-56, 37:13-22. These limitations
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`corresponddirectly to distinctions between neutral krill oil and polar krill oil described in
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`Example 3 in the specification. See ’453 patent at 21:67-22:3 (describing the use of a polar
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`solvent, ethanol), 27:50-60 (Table 16 showing astaxanthin esters for neutral krill oil below 100
`mg/kg and much higher amountsforpolarkrill oil). Claim 1 ofthe ’752 patent requires “about
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`40% phosphatidylcholine w/w,” which correspondsto an analysis of polar lipids in Example 4 in
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`the specification. See ’752 patent at 27:58-64, 29:1-12 (Table 18B showing 67 g/100g of
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`phosphatidylcholine). The limitations that characterize the claimedpolar krill oil are thus
`specified in the claim languageitself, and it would be improperto import additional unclaimed
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`limitations from the specification.
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`The prosecution history further confirms that Respondents’ proposed construction is
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`incorrect. The original claims of the ’453 patent included an explicit limitation requiring
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`“supercritical fluid extraction,” but this language was removed from the claims during
`prosecution in favorof, inter alia, the limitations discussed above requiring a “polar solvent” and
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`a minimum level of astaxanthin esters:
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`1.
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`(Currently amended) A method of production ofpolar krill oil from
`Euphausia superba kit comprising:
`a) Treating denaturing the Euphausia superba kl todenature
`lipases and phospholipases to provide a denatured krill product;
`and
`b) extracting contacting the denaturedkrill product with
`supercriticalfiridextraction
`a polar solvent to extract previde a
`polar krill oil comprising phospholipids, wherein said polar krill
`oil comprising phospholipids is further characterized in
`comprising greater than about 3% ether phospholipids w/w of
`said polarkrill oil; from about 27% to 50% non-ether
`phospholipids w/w ofsaid polar krill oil so that the amount of
`total phospholipidsis from about 30% to 60% w/w of said polar
`krill oil; from abo