throbber
Trials@uspto.gov
`571-272-7822
`
`Paper 6
` Date: April 12, 2021
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROST AS,
`Petitioner,
`v.
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`
`IPR2020-01532
`Patent 9,644,169 B2
`
`
`Before ERICA A. FRANKLIN, JON B. TORNQUIST, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`TORNQUIST, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
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`IPR2020-01532
`Patent 9,644,169 B2
`
`INTRODUCTION
`I.
`A. Background and Summary
`Rimfrost AS (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`an inter partes review of claims 1–20 of U.S. Patent No. 9,644,169 B2
`(Ex. 1001, “the ’169 patent”). Aker Biomarine Antarctic AS (“Patent
`Owner”) did not file a Preliminary Response to the Petition.
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2019). The standard
`for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter
`partes review may not be instituted “unless the Director determines . . . there
`is a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`After considering Petitioner’s arguments and evidence, and for the
`reasons set forth below, we determine that Petitioner has demonstrated a
`reasonable likelihood of prevailing with respect to at least one claim
`challenged in the Petition. Accordingly, we institute an inter partes review
`of all claims and grounds set forth in the Petition.
`B. Real Parties in Interest
` Petitioner identifies itself, Olympic Holding AS, Emerald Fisheries
`AS, Rimfrost USA, LLC, Rimfrost New Zealand Limited, and Bioriginal
`Food and Science Corp. as real parties in interest. Pet. 3. Based on various
`ownership interests, and out of “an abundance of caution,” Petitioner also
`identifies Stig Remøy, SRR Invest AS, Rimfrost Holdings AS, and Omega
`Protein Corporation as real parties in interest. Id.
`Patent Owner identifies itself as a real party in interest in this
`proceeding. Paper 5, 1.
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`IPR2020-01532
`Patent 9,644,169 B2
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`C. Related Matters
`Petitioner and Patent Owner identify several related matters.
`Specifically, the parties identify Aker Biomarine Antarctic AS v. Olympic
`Holding AS, Case No. 1:16-CV-00035-LPS-CJB (D. Del.), which involved
`U.S. Patent Nos. 9,028,877 B2 (“the ’877 patent”) and 9,078,905 B2 (“the
`’905 patent”). Pet. 3–4; Paper 5, 1. The parties further identify
`Investigation No. 337-TA-1019 by the United States International Trade
`Commission, which involved the ’877 and ’905 patents, as well as U.S.
`Patent No. 9,320,765 (“the ’765 patent”), U.S. Patent No. 9,375,453 (“the
`’453 patent”), and U.S. Patent No. 9,072,752 (“the ’752 patent”). Pet. 4;
`Paper 5, 1–2.
`The parties also identify the following Board proceedings as related
`matters:
`• IPR2017-00745 and IPR2017-00747, which requested review
`of the ’905 patent (all challenged claims found unpatentable
`(Ex. 1103), decision affirmed on appeal (Ex. 1154));
`• IPR2017-00746 and IPR2017-00748, which requested review
`of the ’877 patent (all challenged claims found unpatentable
`(Ex. 1104), decision affirmed on appeal (Ex. 1154));
`• IPR2018-00295, which requested review of the ’765 patent (all
`challenged claims found unpatentable (Ex. 1129));
`• PGR2018-00033, which requested review of U.S. Patent
`No. 9,644,170 (institution denied because the challenged patent
`was not eligible for post grant review);
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`Patent 9,644,169 B2
`• IPR2018-01178 and IPR2018-01179, which requested review
`of the ’453 patent (all challenged claims found unpatentable
`(Exs. 1157, 1158));
`• IPR2018-01730, which requested review of the ’752 patent (all
`challenged claims found unpatentable (Ex. 1159)); and
`• IPR2020-01533, which requested review of U.S. Patent No.
`9,816,046 B2 (pending).
`Pet. 4–7; Paper 5, 2–4.
`
`D. The ’169 Patent
`The ’169 patent discloses extracts from Antarctic krill that include
`bioactive fatty acids. Ex. 1001, 1:22–23. The ’169 patent explains that krill
`oil compositions, including compositions having up to 60% w/w
`phospholipid content and as much as 35% w/w EPA/DHA1 content, were
`known in the art. Id. at 1:57–60. The ’169 patent further explains that
`“[k]rill oil compositions have been described as being effective for
`decreasing cholesterol, inhibiting platelet adhesion, inhibiting artery plaque
`formation, preventing hypertension, controlling arthritis symptoms,
`preventing skin cancer, enhancing transdermal transport, reducing the
`symptoms of premenstrual symptoms or controlling blood glucose levels in
`a patient.” Id. at 1:49–55.
`
`According to the ’169 patent, frozen krill are typically transported
`from the Southern Ocean to a processing site, but lipases and phospholipases
`within the krill can result in the decomposition of glycerides and
`phospholipids during transport. Id. at 2:6–16, 9:61–10:8. To avoid the
`
`
`1 According to the ’169 patent, “EPA” is 5,8,11,14,17-eicosapentaenoic acid
`and “DHA” is 4,7,10,13,16,19-docosahexanoic acid. Ex. 1001, 9:12–16.
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`problem of enzymatic decomposition of krill products, the ’169 patent
`describes a method of thermally denaturing the lipases and phospholipases
`in fresh-caught krill prior to storage and processing. Id. at 10:5–10, 10:45–
`50. The ’169 patent reports that these denaturing steps allow for the storage
`of krill material “for from about 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, or 12 months to
`about 24 to 36 months prior to processing.” Id. at 10:36–44.
`After denaturation, the krill can be subject to extraction processes
`either on board the ship or at a remote location. Id. at 10:38–40. In one
`embodiment, krill oils are extracted from krill meal in two stages. Id. at
`9:54–55. In the first stage, a neutral fraction is extracted using either neat
`supercritical CO2 or CO2 in combination with 5% ethanol. Id. at 9:55–57. In
`the second stage, polar lipids (phospholipids) are extracted by adding at least
`20% ethanol to the supercritical CO2 extraction medium. Id. at 9:58–60.
`The ’169 patent reports that “[k]rill oil extracted from denatured krill meal
`by supercritical fluid extraction even 19 months after the production of the
`meal contained virtually no decomposed phospholipids.” Id. at 11:3–6. The
`’169 patent further reports that the novel krill oil compositions of the
`invention are “characterized by containing high levels of astaxanthin,
`phospholipids, includ[ing] enriched quantities of ether phospholipids, and
`omega-3 fatty acids.” Id. at 9:46–49.
`E. Illustrative Claim
`Petitioner challenges claims 1–20 of the ’169 patent. Of those claims,
`claims 1 and 12 are independent. Claims 2–11 depend, directly or indirectly
`from claim 1, and claims 13–20 depend, directly or indirectly, from claim
`12. Claim 1 is illustrative of the challenged claims and is reproduced below:
`1. A method of production of krill oil comprising:
`a) providing krill;
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`Patent 9,644,169 B2
`b) treating said krill to denature lipases and phospholipases in said
`krill to provide a denatured krill product;
`c) storing said denatured krill product for a storage period of from 1 to
`24 months;
`d) after said storage period, extracting oil from said denatured krill
`product with a polar solvent to provide a krill oil with from about 3%
`to about 15% ether phospholipids w/w of said krill oil astaxanthin
`esters in amount of greater than about 100 mg/kg of said krill oil.
`
`Ex. 1001, 35:45–55.
`F. Prior Art and Asserted Grounds
`Petitioner asserts that claims 1–20 of the ’169 patent would have been
`unpatentable on the following grounds:
`35
`Reference(s)/Basis
`U.S.C. §
`103(a)2 Breivik II, 3 Catchpole,4 Budziński,5
`Fricke,6 Randolph7
`103(a) Breivik II, Catchpole, Budziński,
`Fricke, Randolph, Sampalis I8
`
`Claims Challenged
`
`1–5, 7–15, 17–20
`
`6, 16
`
`
`2 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the ’169
`patent has an effective filing date before the March 16, 2013, effective date
`of the applicable AIA amendments, we refer to the pre-AIA versions of
`35 U.S.C. §§ 102 and 103.
`3 Breivik, WO 2008/060163 A1, published May 22, 2008 (Ex. 1037).
`Breivik claims priority to U.S. Provisional Application No. 60/859,289, filed
`November 16, 2006. Ex. 1037, [30].
`4 Catchpole, WO 2007/123424 A1, published Nov. 1, 2007 (Ex. 1009).
`5 Budziński et al., Possibilities of processing and marketing of products
`made from Antarctic krill, FAO Fish. Tech. Pap. (268):46 (1985) (Ex. 1008).
`6 Fricke et al., Lipid, Sterol and Fatty Acid Composition of Antarctic Krill
`(Euphausia superba Dana), 19(11) LIPIDS 821–827 (1984) (Ex. 1010).
`7 Randolph et al., US 2005/0058728 A1, published Mar. 17, 2005
`(Ex. 1011).
`8 Sampalis et al., Evaluation of the Effects of Neptune Krill Oil™ on the
`Management of Premenstrual Syndrome and Dysmenorrhea, 8(2) ALT.
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`In support of its obviousness arguments, Petitioner further relies on the
`testimony of Dr. Stephen J. Tallon (Ex. 1006).
`
`II. ANALYSIS
`A. Claim Construction
`In this proceeding, the claims of the ’169 patent are construed “using
`the same claim construction standard that would be used to construe the
`claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b)..
`Under that standard, the words of a claim are generally given their “ordinary
`and customary meaning,” which is the meaning the term would have had to
`a person of ordinary skill at the time of the invention, in the context of the
`entire patent including the specification. Phillips v. AWH Corp., 415 F.3d
`1303, 1312–13 (Fed. Cir. 2005) (en banc).
`Petitioner provides proposed claim constructions for the terms “krill
`oil,” “denature lipases and phospholipases,” “polar solvent,” “astaxanthin
`esters,” “krill meal,” and “freshly harvested.” Pet. 32–39. Upon review of
`the arguments and evidence presented at this stage of the proceeding, we
`determine that construction of the identified claim terms is not necessary for
`purposes of this Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999) (only terms that are in controversy need
`to be construed, and only to the extent necessary to resolve the controversy).
`
`
`MED. REV. 171–179 (2003) (Ex. 1012).
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`IPR2020-01532
`Patent 9,644,169 B2
`B. Claims 1–5, 7–15, and 17–20 over Breivik II, Catchpole, Budziński,
`Fricke, and Randolph
`Petitioner contends that claims 1–5, 7–15, and 17–20 would have been
`obvious over the combined disclosures of Breivik II, Catchpole, Budziński,
`Fricke, and Randolph. Pet. 42–66.
`1. Breivik II9
`Breivik II discloses “a process for preparing a substantially total lipid
`fraction from fresh krill,” as well as “a process for separating phospholipids
`from the other lipids.” Ex. 1037, 1:8–10. Breivik II explains that krill are
`“small, shrimp-like animals, containing relatively high concentrations of
`phospholipids” and that the krill with the “greatest potential for commercial
`utilization is the Antarctic Euphausia superba” (“E. superba”). Id. at 1:25–
`28. Breivik II further explains that fresh krill contains up to around 10%
`lipids, and in E. superba approximately 50% of these lipids are
`phospholipids. Id. at 1:32–33.
`Breivik II notes that lipases within the krill’s digestive tract remain
`active after the krill is harvested and may hydrolyze part of the krill lipids,
`potentially resulting in a krill oil with undesired amounts of free fatty acids.
`Id. at 2:6–9. To prevent this enzymatic activity, Breivik II discloses an
`optional heat treatment phase that inactivates krill lipases, “thus ensuring a
`product with very low levels of free fatty acids.” Id. at 4:3–6.
`Once the lipases are inactivated, the lipids may be extracted from the
`krill meal. See id. at 9:29–10:12. Breivik II explains that it was known in
`
`
`9 Petitioner contends that Breivik II is prior art to the ’169 patent under
`35 U.S.C. § 102(e), based on the November 16, 2006 filing date of U.S.
`Provisional Application No. 60/859,289. Pet. 11.
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`the art to extract lipids from krill by successive extraction at low
`temperatures using organic solvents like acetone and ethanol or by
`supercritical fluid extraction using carbon dioxide. Id. at 2:21–31. These
`methods, however, either required large amounts of organic solvents or
`resulted in a product “mainly consisting of unpolar lipids (mostly
`triglycerides), and no phospholipids.” Id. at 2:23–24, 2:28–29. To
`overcome the problems disclosed in the art, Breivik II teaches an extraction
`process that provides a substantially total lipid fraction that includes
`triglycerides, astaxanthin, and phospholipids from fresh krill, without using
`organic solvents like acetone. Id. at 3:19–20, 3:26–31.
`In one embodiment, Breivik II describes an extraction process in
`which fresh krill is washed with ethanol and the ethanol-washed krill is then
`extracted with supercritical CO2 containing 10% ethanol. Id. at 7:31–8:3
`(Example 2). Breivik II also discloses an optional, pre-treatment step in
`which the raw material is heated at 80ºC for 5 minutes before the first wash
`with ethanol (Example 6), which Breivik II reports results in “an increased
`yield of lipids compared to the same treatment with no heating.” Id. at 9:5–
`11, 9:33–34 (emphasis omitted), 12:1–9 (noting that the lipid fraction of the
`inventive product would be expected, among other things, to contain
`substantially less hydrolyzed and/or oxidized lipids than lipid produced by
`conventional processes).
`
`2. Catchpole
`Catchpole discloses “a process for separating lipid materials
`containing phospholipids.” Ex. 1009, 1:5–6, 3:27–28. Catchpole explains
`that phospholipids “have been implicated in conferring a number of health
`benefits including brain health, skin health, eczema treatment, anti-infection,
`wound healing, gut microbiota modifications, anticancer activity, alleviation
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`of arthritis, improvement of cardiovascular health, and treatment of
`metabolic syndromes.” Id. at 1:29–2:2. Catchpole further explains that
`products having high levels of particular phospholipids “may be employed
`in a number of applications, including infant formulas, brain health, sports
`nutrition and dermatological compositions.” Id. at 25:9–13.
`In Example 18, Catchpole describes the fractionation of krill lipids
`from krill powder using a process that employs supercritical CO2 in a first
`extraction and then CO2 and ethanol in a second extraction. Id. at 24:1– 16.
`Table 16 of Catchpole is reproduced below.
`
`
`
`Table 16 reports the phospholipid concentrations present in the krill oil
`extract obtained in Example 18. Id. at Table 16. As shown in Table 16,
`Extract 2 has a total phospholipid concentration of 45.1%, and includes
`39.8% phosphatidylcholine (“PC”), 4.6% alkylacylphosphatidylcholine
`(“AAPC”), and 0.2% alkylacylphosphatidylethanolamine (“AAPE”). Id.;
`see also id. at 1:11–15 (defining PC, PI, PS, PE, and CL).
`3. Budziński
`Budziński “presents the current state of possible commercial-scale
`uses of krill-processing technologies,” including processing technologies for
`products for “human consumption, animal feed, and industrial purposes.”
`Ex. 1008, Abstr. Budziński explains that the “main difficulty in krill
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`processing” is caused by proteolytic enzymes, such as lipases. Id. at 6.10
`According to Budziński, lipases “cause the decomposition of phospholipids
`and, to a lesser degree, triglycerides,” resulting in an increase of free fatty
`acids in krill oil. Id. at 6–7. To avoid enzyme degradation of krill products,
`Budziński explains that storage time for raw krill products “should be as
`short as possible” and that vessels “must be properly equipped for
`processing” krill as soon as possible after capture. Id. at 9, 20 (“Efforts
`should be made to regulate catches so that the time before processing is as
`short as possible.”), 25 (“Due to its technological properties, the raw
`materials should be processed as soon as possible after capture. The only
`way to meet this requirement is to install processing facilities on-board the
`vessel.”). Budziński discloses that the optimum temperature for heating krill
`is believed to be 80–85 ℃ and that properly processed krill meal is “stable
`for 13 months of storage without addition of antioxidants.” Id. at 20–22.
`4. Fricke
`Fricke reports the total lipid content and composition for krill samples
`caught in the Antarctic Ocean in December 1977 and March 1981.
`Ex. 1010, Abstr., 822. These samples contained approximately 33.3% +/-
`0.5% w/w (1977 sample) and 40.4% +/- 0.1% w/w (1981 sample)
`triacylglycerols. Id. Fricke notes that samples from the 1977 sample
`contained free fatty acid levels that were about twice that of the 1981
`sample. Id. at 822. In contrast, samples of the same haul that had been
`cooked on board “immediately after hauling,” showed a free fatty acid
`
`
`10 Citations are to the original page numbers of the document that are
`centered at the top of each page.
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`content that “was much lower, ranging from 1% to 3% of total lipids.” Id. at
`822–23.
`
`5. Randolph
`Randolph discloses compositions for modulating an inflammatory or
`immunomodulatory response, including krill oil. Ex. 1011 ¶ 8. The krill oil
`of Randolph may be obtained from any member of the Euphausia family,
`including Euphausia superba, and typically contains “between about 300 mg
`and about 3000 mg of a krill oil ingredient.” Id. ¶¶ 39–40. Randolph further
`teaches that the composition can contain any amount of an astaxanthin
`ingredient, including at least about 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40,
`50, 60, 70, 80, or 90 percent astaxanthin, typically resulting in between
`about 0.5 mg and about 50 mg of astaxanthin in the product. Id. ¶ 44.
`Randolph explains that the ingredients of the composition can be
`processed into various “delivery systems,” such as capsules, soft gel
`capsules, tablets, gel tabs, lozenges, strips, granules, powders, concentrates,
`solutions, lotions, creams or suspensions. Id. ¶¶ 46, 52.
`6. Analysis: Claim 1
`Claim 1(a) requires “providing krill” and claim 1(b) requires
`providing a denatured krill product by treating the krill to denature lipases
`and phospholipases. Ex. 1001, 35:45–47. Petitioner contends that Breivik II
`and Fricke disclose catching krill, Breivik II and Budziński disclose that
`“heat treatment” will inactivate krill enzymes, including lipase, and Fricke
`discloses cooking krill immediately after hauling, which results in a
`processed krill product containing only 1–3% free fatty acids. Pet. 44–45
`(citing Ex. 1037, 4:3–6, 9:5–10, 10:11–12; Ex. 1008, 12, 26; Ex. 1010, 2–3).
`Accordingly, Petitioner contends that Breivik II and Fricke disclose
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`“providing krill,” as recited in claim 1(a), and Breivik II, Budziński, and
`Fricke disclose a denatured krill product, as recited in claim 1(b). Id.
`With respect to “storing said denatured krill product for a storage
`period of from 1–24 months,” as recited in claim 1(c), Petitioner argues that
`Fricke discloses storage of processed krill prior to solvent extraction and
`Budziński discloses that “stable” krill meal can be stored for at least 13
`months. Id. at 45 (citing Ex. 1008, 27–28; Ex. 1010, 2–3; Ex. 1006 ¶¶ 441–
`444).
`
`With respect to extracting oil from the denatured krill product with a
`polar solvent, as recited in claim 1(d), Petitioner contends that Breivik II and
`Catchpole disclose extracting krill oil using superfluid CO2 and ethanol (a
`polar solvent), Fricke discloses extraction using the known polar solvent
`system of chloroform-methanol, and Budziński discloses extracting krill oil
`using various organic solvents. Id. at 46 (citing Ex. 1037, 9:5–26; Ex. 1009,
`24:1–19; Ex. 1010, 2–3; Ex. 1008, 30; Ex. 1006 ¶¶ 445–449).
`With respect to the requirement that the krill oil have from about 3%
`to about 15% ether phospholipids, as well as astaxanthin esters in an amount
`greater than about 100 mg/kg of said krill oil, as recited in claim 1(d),
`Petitioner contends that Catchpole describes a krill oil containing 4.8% ether
`phospholipids and Randolph discloses a krill oil having at least 158 mg/kg
`of astaxanthin esters. Id. at 47–49 (citing Ex. 1006 ¶¶ 190–196, 211, 264,
`450–452, 482–483; Ex. 1009, 14:7–11, Table 16; Ex. 1011 ¶¶ 40–41).
`Petitioner contends one of ordinary skill in the art would have
`combined the various disclosures of Breivik II, Catchpole, Budziński,
`Fricke, and Randolph to arrive at the subject matter of the challenged claims
`because each reference is in the same field of endeavor and it was well
`known in the art that lipases and phospholipases in fresh krill should be
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`denatured prior to storage to prevent spoilage. Pet. 59–60. Petitioner
`further contends that one of ordinary skill in the art would have sought to
`store denatured krill products for up to 13 months, as disclosed in Budziński,
`in order to allow for cheaper land-based extraction of krill products using
`polar solvents. Id. at 60–61. Finally, Petitioner contends one of ordinary
`skill in the art would have sought to obtain the claimed levels of ether
`phospholipids and astaxanthin esters, as disclosed in Catchople and
`Randolph, in view of the known health benefits of these compounds. Id. at
`63–65.
`As noted above, Patent Owner did not file a Preliminary Response
`challenging Petitioner’s arguments.
`Upon review of Petitioner’s arguments and supporting evidence, we
`determine that, on this record, Petitioner sufficiently demonstrates that
`Breivik II, Catchpole, Budziński, Fricke, and Randolph teach or suggest
`every limitation of claim 1 of the ’169 patent. Petitioner also sufficiently
`explains for purposes of institution why one of ordinary skill in the art would
`have combined these disclosures to arrive at the subject matter of claim 1.
`Accordingly, on this record, Petitioner demonstrates a reasonable likelihood
`that claim 1 would have been obvious over Breivik II, Catchpole, Budziński,
`Fricke, and Randolph.
`7. Analysis: Claims 2–5, 7–15, and 17–20
`Independent claim 12 is similar to independent claim 1, but further
`requires “treating freshly harvested krill.” Compare Ex. 1001, 35:45–55
`with id. at 36:30–40. Petitioner contends that Breivik II expressly describes
`a process for “preparing a substantially total lipid fraction from fresh krill.”
`Pet. 50 (citing Ex. 1037, 3:29–30).
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`With respect to dependent claims 2–5, 7–11, 13–15 and 17–20,
`Petitioner identifies where: (1) Breivik II, Budziński, and Fricke teach or
`suggest treating krill on a ship to denature lipases and phospholipases, as
`recited in claim 2 (Pet. 53 (citing Ex. 1006 ¶¶ 454–457)); (2) Breivik II,
`Budziński, and Fricke disclose using heat to denature krill lipases and
`phospholipases, as recited in claims 3 and 13 (id. at 53–54 (citing Ex. 1006
`¶¶ 458–463)); Budziński and Fricke disclose denaturing krill meal, as recited
`in claims 4 and 14 (id. at 54–55 (citing Ex. 1006 ¶¶ 464–467)); Breivik II,
`Budziński, and Fricke disclose processing freshly harvested krill, as recited
`in claims 5 and 15 (id. at 55 (citing Ex. 1006 ¶¶ 468–472)); Breivik II,
`Budziński, and Fricke disclose the use of Antarctic krill, as recited in claims
`7 and 17 (id. at 56 (citing Ex. 1006 ¶¶ 473–478)); Breivik II, Budziński, and
`Fricke disclose the use of Euphausia superba, as recited in claims 8 and 18
`(id. at 56–57 (citing Ex. 1006 ¶¶ 474–478)); Randolph and Breivik II
`disclose krill oil compositions with greater than 200 mg/kg astaxanthin
`esters, as recited in claims 9 and 19 (id. at 57–58 (citing Ex. 1006 ¶¶ 479–
`485)); Catchpole discloses an extracted krill oil having at least 30% total
`phospholipids, as recited in claims 10 and 20 (id. at 58 (citing Ex. 1006
`¶¶ 486–489)); and Catchpole discloses a krill oil with at least 30%
`phosphatidycholine, as recited in claim 11 (id. at 59 (citing Ex. 1006 ¶¶ 490–
`491)).
`Upon review of Petitioner’s arguments and evidence, and based on the
`current record, we determine that Petitioner has demonstrated a reasonable
`likelihood of prevailing with respect to claims 2–5, 7–15, and 17–20.
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`C. Claims 6 and 16 over Breivik II, Catchpole, Budziński, Fricke,
`Randolph, and Sampalis I.
`Claims 6 and 16 depend from claims 1 and 12, respectively, and
`further require encapsulating the krill oil. Ex. 1001, 36:17–18, 36:47–48.
`Petitioner contends the subject matter of claims 6 and 16 would have been
`obvious over the combined disclosures of Breivik II, Catchpole, Budziński,
`Fricke, Randolph, and Sampalis I. Pet. 66–68.
`1. Sampalis I
`Sampalis I discloses the health benefits of an encapsulated krill oil
`product and, in particular, reports that two soft gels of the product taken
`daily “can significantly reduce the physical and emotional symptoms related
`to premenstrual syndrome.” Ex. 1012, Abstr.
`2. Analysis
`Petitioner contends that one of ordinary skill in the art would have
`found it obvious to encapsulate krill oil extracts in view of Sampalis I’s
`disclosure of encapsulating krill oil to form a medically beneficial krill oil
`product, and in view of the established understanding in the art that
`encapsulated krill oil extracts provide a “convenient and easy to administer
`dosage form.” Pet. 67–68 (citing Ex. 1006 ¶¶ 64, 69, 218).
`Upon review of Petitioner’s arguments and supporting evidence, on
`the current record, we determine that Petitioner demonstrates a reasonable
`likelihood that claims 6 and 16 would have been obvious over Breivik II,
`Catchpole, Budziński, Fricke, Randolph, and Sampalis I.
`D. Conclusion
`After considering Petitioner’s arguments and supporting evidence, we
`determine that, on the current record, the information presented shows a
`reasonable likelihood that Petitioner would prevail in establishing that
`
`16
`
`

`

`IPR2020-01532
`Patent 9,644,169 B2
`claims 1–20 of the ’169 patent are unpatentable on the grounds asserted in
`the Petition.
`
`III. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 1–20 of the ’169 patent is hereby instituted on the grounds
`set forth in the Petition; and
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial, which
`commences on the entry date of this decision.
`
`17
`
`

`

`IPR2020-01532
`Patent 9,644,169 B2
`FOR PETITIONER:
`
`James Harrington
`jharringto@hbiplaw.com
`
`Michael Chakansky
`mchakansky@hbiplaw.com
`
`John Gallagher
`jgallagher@bhiplaw.com
`
`
`
`FOR PATENT OWNER:
`David Casimir
`dacasimir@casimirjones.com
`
`John Jones
`jmjones@casimirjones.com
`
`
`
`18
`
`

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