PUBLIC VERSION
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`UNITED STATES INTERNATIONAL TRADE COMMISSION
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`Washington, DC.
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`
`
`In the Matter of
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`CERTAIN KRILL OIL PRODUCTS AND
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`Inv. No. 337-TA—1019
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`KRILL MEAL FOR PRODUCTION OF
`KRILL OIL PRODUCTS
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`.1
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`ORDER NO. 13':
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`MARKMAN ORDER
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`(April 13, 2017)
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`A Markman hearing was held 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 Zealand Limited, and Bioriginal Food & Science Corp. appeared at
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`the hearing. In advance of the hearing, Complainants and Respondents filed initial and rebuttal
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`Markman briefsl’2
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`
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`1 Complainants filed a corrected initial 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 ................................................................................................ 1
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`LEGAL STANDARD .......................................................................................................... 1
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`ASSERTED PATENTS ....................................................................................................... 3
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`LEVEL OF ORDINARY SKILL IN THE ART ............................................................... 4
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`DISPUTED TERMS ............................................................................................................ 5
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`“krill oil” ............................................................................................................................... 5
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`“polar krill oil” ...........................................'..........................'
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`.................................. 10
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`“krill” and “Euphausia superba” .............. 15
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`“denatured krill product” ................................................................................................. 16
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`“astaxanthin” ...................................................................................................................... 1 8
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`CONCLUSION .................................................................................................................. 26
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`ii
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`, I.
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`PROCEDURAL HISTORY
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`This investigation was instituted to determine whether there is a Violation of section 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 infringement of certain claims of US.
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`Patent No. 9,028,877 (the “’877 patent”); US. Patent No. 9,078,905 (the “’905 patent”); US.
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`Patent No. 9,072,752 (the “’752 patent”); US. Patent No. 9,320,765 (the “’765 patent”); and
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`US. 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—1 8 of
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`the ’877 patent; claims 1, 7, and 11—13 ofthe ’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 ofthe ’765 patent; and claims 1, 5-10, 12, 14—17, 19-20,
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`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 common specification.
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`The parties’ Markman briefing addresses six disputed claim terms, each of which appears in the
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`claims of several of the asserted patents.
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`II.
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`LEGAL STANDARD
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`“The construction of claims is simply a way of elaborating the normally terse claim
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`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 Scrzpps Clinic v. Genentech, Inc, 927 F.2d 1565, 1580 (Fed. Cir. 1991)). “[O]n1y those
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`[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. A WH Corp,
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`415 F.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,” which is “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.” Id at 1313.
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`“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention
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`to which the patentee is entitled the right to exclude.’” Id. at 1312. “Quite apart from the written
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`description and the prosecution history, the claims themselves provide substantial guidance as to
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`the meaning of particular claim terms.” Id 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 enlightenment as to the
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`meaning of a claim term.” Id
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`“[T]he specification ‘is always highly relevant to the claim construction analysis.
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`Usually, it is disp’ositive; it is the single best guide to the meaning of a disputed term.” Id. 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 axioms that (a) a claim must be read in
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`View of the specification and (b) a court may not read 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.” Id In such cases, “the inventor has dictated the
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`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 of the patent.
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`Like the specification, the prosecution history provides evidence of how the PTO and the
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`inventor understood the patent.” Id. at 1317. “[T]he prosecution history can often inform the
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`meaning of 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.” Id
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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 learned treatises.”
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`Id at 1317. Extrinsic evidence is generally Viewed “as less reliable than the patent and its
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`prosecution history in determining how to read claim terms.” Id at 1318. “The court may
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`receive extrinsic evidence to educate itself about the invention and the relevant technology, but
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`the court may not use extrinsic evidence to arrive at a claim construction that is clearly at odds
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`with the construction mandated by the intrinsic evidence.” Elkay Mfg. Co. v. Ebco Mfg. Ca, 192
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`F.3d 973, 977 (Fed. Cir. 1999).
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`III. 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, US. Patent Application No. 12/057,775, was
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`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
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`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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`of polar krill oil. The ’752 patent, entitled “BiOeffective Krill Oil Compositions,” issued on July
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`7, 2015, with two independent claims for specific compositions of krill 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 of krill oil from
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`Antarctic krill. In the prior art, frozen krill was transported over long distances for processing.
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`’877 patent at 23-16. The patents describe the downsides of this transportatiOn, which “is both
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`expensive and can result in degradation of the krill starting material.” Id. at 2:5-6. To avoid
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`these problems, the patents describe a process where krill meal is “processed on board a ship in
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`Antarctica using live krill as starting material.” Id. at 9233-3 6. This processing includes a
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`“protein denaturation step” followed by the extraction of krill oil. Id. at 9:48-54. This extraction
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`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. Id. at 9:36-42. The result of the process is krill oil
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`“characterized by containing high levels of astaxanthin, phospholipids, includ[ing] enriched
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`quantities of ether phospholipids and omega-3 fatty acids.” Id. at 9228—3 1.
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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
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`person of ordinary skill in the art would have held an advanced degree in a relevant scientific
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`field,3 knowledge of or experience in the field of extraction, and at least five years’ post—graduate
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`experience. RIB at 11. Although Respondents propose a more advanced standard for ordinary
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`skill in the art, this dispute between the parties does not affect the construction of any of the
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`disputed terms, and it is not resolved at this time.
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`v.
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`’ DISPUTED TERMS
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`The parties briefed six disputed terms from the asserted patents, and five of these terms
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`remain disputed.4
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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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` "Respondents , Vnghonstrgiction'
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`
`
`f .
`.
`,
`_ [Gomlainéfiisi”Gnfiétnuction
`oil virtually free of
`“krill oil”
`oil produced from krill
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`enzymatically decomposed oil
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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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`
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`Complainants propose that 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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`3 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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`4 The parties previously disputed the terms “freshly harvested” and “freshly caught,” but during
`the Markman hearing, the parties agreed that the claim language itself 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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`which states:
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`The present invention provides methods to avoid decomposition of
`glycerides and phospholipids in krill oil and compositions
`produced by those methods. The product obtained by these new
`methods is virtually free of enzymatically decomposed oil
`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 claims to krill oil that is Virtually free of enzymatically decomposed oil 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 claimed krill oil from the prior art 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 order to 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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`.
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`. .”), 9:43—45 (“The present invention provides methods to
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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 enhance the quality of krill oil”). There is no indication that the patentee
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`acted as his own lexicographer when using the term “krill oil” or disclaimed the full scope of the
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`term “krill oil” in the specification or during prosecution. . See Thorner v. Sony Computer
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`Entertainment America LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).
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`At the Markman hearing, Respondents cited 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 where the references to a certain limitation as being
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`the ‘invention’ are not uniform, or where other portions of the intrinsic evidence do not support
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`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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`‘ decomposed oil constituents is only one of many descriptions of 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 of the “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
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`compositions characterized by containing high levels of astaxanthin, phospholipids, included
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`[sic] an enriched, quantities of ether phospholipids, and omega-3 fatty acids.” ’877 patent at
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`9:28-31. These components of the claimed krill oil are consistently referenced more prominently
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`in the specification than the decomposed oil 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 amount of phospholipids, astaxanthin esters, and/or triglycerides are
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`explicitly claimed in the independent claims of the asserted patents. See, e. g, ’765 patent at
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`claim 1, 34:364—3525 (“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 of said krill oil so that the
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`amount of total phospholipids in the composition is from about 30% to 60% w/W of said krill oil;
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`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.”).5 When read in the context of these other
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`statements in the specification and the claims, the avoidance of decomposed oil 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 numerous instances of this phrase in the specification. In the “Summary of
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`the Invention,” the phrase “the present invention” is invoked more than forty times, describing
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`different aspects of the invention such as 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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`
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`5 See also ’877 patent at 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 phospholipids in 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 polar krill oil comprising phospholipids, said
`polar krill oil comprises greater than about3% ether phospholipids w/w of said polar krill oil;
`from about 27% to 50% non-ether phospholipids W/W of said polar krill oil so that the amount of
`total phospholipids is from about 30% to 60% w/w of said polar krill oil; from about 20% to 50%
`triglycerides w/w of said polar krill oil, and astaxanthin esters in amount of greater than about
`‘ 100 mg/kg of said 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 of said 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. Id. at 9:43-14:46. Respondents
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`have failed to make a compelling argument for importing a “decomposed oil constituents”
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`limitation into the claims while ignoring the many other 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 may all be important benefits of the invented krill oil, but the
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`Federal Circuit has warned that “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), aff’d, 564
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`US. 91 (2011).
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`Other claim language in 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
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`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
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`claim 1, 34:61-62 (“treating said krill to denature lipases and phospholipases in said krill to
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`provide a denatured krill 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 denatured krill product”).
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`The patentees are entitled to claim this feature by reference to a denaturation step rather than by
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`specifying the content of decomposed oil constituents. See Phillips, 415 F.3d at 1312 (“It is a
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`‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to which the
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`patentee is entitled the right to exclude.”’) (quoting Innova, 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, which relates 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 percentages of 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 attached to 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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`patent at claim 13 (“wherein from about 70% to 95% of said omega—3 fatty acids are attached to
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`said total phospholipids”). Byrequiring a high percentage of attached fatty acids, these
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`limitations limit the percentage of unattached “free” fatty acids, which is the limitation that
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`Respondents propose to incorporate into their construction.6 The presence of this limitation in
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`dependent claims “gives rise to a presumption that the limitation in question is not present in the
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`independent claim.” Phillips, 415 F.3d at 1315. The language of the dependent claims thus
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`further counsels against the adoption of Respondents’ proposed construction.
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`When the 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 claims of the ’453 and ’752 patents.
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`
`
`
`
`
`
`‘KééiiiplailiantSiIGb'n'stnu'cti'o‘in l"Resp_oill—lieflgyéofiétnucii'dh'
`_T;e11m_/
`H
`krill oil containing polar lipids
`krill oil containing polar lipids
`“polar krill oil”
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`obtained from supercritical
`extraction with polar entrainer
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`
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`6 As described during the tutorial, one of the advantages of krill is that the fatty acids are
`“attached” to phospholipids, and a problem that the invention was trying to solve is that these
`fatty acids detach and become “free” in the decomposition process. Tutorial Tr. at 36—3 7; ’877
`patent at 2:3-13.
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`10
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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 contend that it 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 the krill oil is extracted—specifying that polar krill oil must be
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`“obtained from supercritical extraction with polar entrainer.”7
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`The embodiment in Example 3 of the 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 two stages.” ’453 patent at 21:64—65. In
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`thefirst stage, “neutral krill oil” is removed using carbon dioxide. Id. at 21 :65-67. In the second
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`stage, ethanol is 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.” Id. 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
`comparison to prior art krill oil. Id. at 22:15—27:60. The term “polar krill oil” is also referenced
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`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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`produce a polar krill oil.” ’453 patent at 11:10-14. In another part of the specification, there is
`an embodiment of “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.” Id. 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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`7 The claim language in the ’453 patent uses the term “polar solvent,” ”453 patent at 35:47-48,
`and Respondents confirmed that 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 distinguishes polar .
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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). RRBat 7—10. Supercritical fluid extraction is used for both neutral krill oil
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`and polar krill oil. ”453 patent at 21:64-22:14. Respondents are correct that in Example 3,
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`ethanol is not used for the extraction of neutral krill oil but only for polar krill oil. Id. at 21 :65-
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`2223. The use of ethanol is only one of many distinctions between these two types of 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. Id. at 22:3-27:60. In addition, Example 3
`describes differences in the pressure and length of time for the extraction ofneutral krill oil and
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`polar krill oil. Compare id. 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”) to 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 indicates that 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 of 9% 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
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`specification to suggest that Respondents’ two proposed limitations, supercritical fluid extraction
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`and polar entrainer, are the defining, features of polar krill oil in the asserted patents.
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`Respondents havenot identified any definitions or disclaimers in 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 of the
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`embodiments described in the specification.
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`Another part of the 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.
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`’453 patent at 31:44-54. In Example 7, both
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`stages of a two—stage extraction process are performed “using supercritical fluid extraction with
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`co-solvent.” Id. at 31:44-45. This includes a 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%.” Id. at 31:44—54. This embodiment is referenced in another part of the
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`specification, stating: ”Surprisingly, it has been found that use of a low amount of polar solvent
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`in the C02 as an entrainer facilitates the extraction of neutral lipid components and astaxanthin in
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`a single step.” Id. at 11:24—27. When the 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 other krill oil. 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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`correspond directly 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 amounts for. polar krill oil). Claim 1 of the ’752 patent requires “about
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`40% phosphatidylcholine w/w,” which corresponds to 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 claimed polar krill oil are thus
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`specified in the claim language itself, and it would be improper to 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
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`prosecution in favor of, 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 of polar krill oil from
`Euphausia superba krill comprising:
`a) Treating denaturing the Euphausia superba krill to denature
`lipases and phospholipases to provide a denatured krill product;
`and
`b) exiraeting contacting the denatured krill prod