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.
`
`IPR2020-01533
`Patent 9,816,046 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
`
`
`
`
`
`
`
`
`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.
`
`IPR2020-01533
`Patent 9,816,046 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
`
`
`
`
`
`
`
`
`
`IPR2020-01533
`Patent 9,816,046 B2
`
`INTRODUCTION
`I.
`A. Background and Summary
`Rimfrost AS (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`an inter partes review of claims 1–19 of U.S. Patent No. 9,816,046 B2 (“the
`’046 patent”). Aker Biomarine Antarctic AS (“Patent Owner”) did not file a
`Preliminary Response to the Petition.
`An inter partes review may not be instituted unless “the information
`presented in the petition . . . and any response . . . shows that there is a
`reasonable likelihood that the petitioner would prevail with respect to at least
`1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). After
`considering Petitioner’s arguments and evidence, and for the reasons set
`forth below, we determine that the 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. Out of an
`“abundance of caution,” Petitioner also names Stig Remøy, SRR Invest AS,
`Rimfrost Holding AS and Omega Protein Corporation as real parties in
`interest based on their ownership interests in the real parties in interest
`identified by Petitioner. Id.
`Patent Owner identifies itself as a real party in interest. Paper 5, 1.
`C. Related Matters
`Petitioner and Patent Owner identify several related matters.
`Specifically, the parties identify Aker Biomarine Antarctic AS v. Olympic
`
`2
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`IPR2020-01533
`Patent 9,816,046 B2
`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; 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. 3–4; 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);
`• 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
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`Patent 9,816,046 B2
`• IPR2020-01532, which requested review of U.S. Patent No.
`9,644,169 (pending).
`Pet. 4–7; Paper 5, 2–4.
`D. The ’046 Patent
`The ’046 patent discloses extracts from Antarctic krill that include
`bioactive fatty acids. Ex. 1001, 1:24–25. The ’046 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 1:59–62. The ’046 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 1:51–57.
`
`According to the ’046 patent, lipases and phospholipases within krill
`can result in the decomposition of glycerides and phospholipids during
`transport of frozen krill from the Southern Ocean to a processing site. Id. at
`2:8–18, 9:61–63. To avoid the problem of enzymatic decomposition of krill
`products, the ’046 patent describes a method of thermally denaturing the
`lipases and phospholipases in fresh-caught krill prior to storage and
`processing. Id. at 9:63–10:11, 10:45–51. The ’046 patent reports that these
`denaturing steps allow for the storage of krill material “for from about 1, 2,
`
`
`1 According to the ’046 patent, “EPA” is 5,8,11,14,17-eicosapentaenoic acid
`and “DHA” is 4,7,10,13,16,19-docosahexanoic acid. Ex. 1001, 9:13–16.
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`Patent 9,816,046 B2
`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.
`The ’046 patent describes an embodiment wherein krill oil is
`subsequently extracted from the stored krill product using a polar solvent
`and/or supercritical carbon dioxide. Id. at 10:2‒4. In Example 7 of the ’046
`patent, “[k]rill lipids were extracted from krill meal (a food grade powder)
`using supercritical fluid extraction with co-solvent.” Id. at 32:15‒16.
`Initially, 300 bar pressure, 333°K and 5% ethanol (ethanol:CO2,
`w/w) were utilized for 60 minutes in order to remove neutral
`lipids and astaxanthin from the krill meal. Next, the ethanol
`content was increased to 23% and the extraction was maintained
`for 3 hours and 40 minutes. The extract was then evaporated
`using a falling film evaporator and the resulting krill oil was
`finally filtered.
`Id. at 32:17‒24.
`In Example 8, krill oil prepared using the same method described in
`Example 7 was analyzed using 31P NMR analysis to identify and quantify
`the phospholipids in the oil. Id. at 32:48‒51. It was determined that “[t]he
`main polar ether lipids of the krill meal [were] alkylacylphosphatidylcholine
`(AAPC) at 7-9% of total polar lipids, lyso-alkylacylphosphatidylcholine
`(LAAPC) at 1% of total polar lipids (TPL), and alkylacylphosphatidyl-
`ethanolamine (AAPE) at <1% of TPL.” Id. at 33:13–17.
`E. Illustrative Claims
`Petitioner challenges claims 1–19 of the ’046 patent. Of those, claims
`1 and 13 are independent. Claims 2–12 depend, directly or indirectly, from
`claim 1 and claims 14–19 depend from claim 13. Claims 1 and 13 are
`illustrative of the challenged claims and are reproduced below:
`
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`Patent 9,816,046 B2
`1. A method of production of krill oil comprising:
`obtaining a krill meal produced by a process comprising
`treating krill to destroy the activity of lipases and phospholipases
`naturally present in krill and wherein said krill meal has been
`stored for period of from 1 to 36 months; and
`extracting krill oil from said krill meal that has been stored
`from 1 to 36 months with a polar solvent to provide a krill oil
`with greater than 30% phosphatidylcholine w/w of said krill oil
`and astaxanthin esters.
`Ex. 1001, 35:48–57.
`13. A method of production of Euphausia superba krill oil
`comprising:
`a) obtaining a Euphausia superba krill meal produced by
`a process comprising treating Euphausia superba to destroy the
`activity of lipases and phospholipases naturally present in
`Euphausia superba and wherein said Euphausia superba krill
`meal has been stored from 1 to 36 months; and
`b) extracting Euphausia superba oil from said krill meal
`that has been stored from 1 to 36 months with a polar solvent to
`provide a Euphausia superba krill oil comprising greater than
`30% phosphatidylcholine w/w of said Euphausia superba krill
`oil, less than 3% free fatty acids w/w of said Euphausia superba
`krill oil, and at least 100 mg/kg astaxanthin esters.
`Id. at 36:42–56.
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`Patent 9,816,046 B2
`F. Challenged Claims and Asserted Grounds
`Petitioner asserts the following grounds of unpatentability:
`Claims
`35 U.S.C.
`Reference(s)/Basis
`Challenged
`§
`103(a)2 Breivik II,3 Yoshitomi,4 Budziński,5
`1–10
`Fricke,6 Bottino II,7 Sampalis I8
`Breivik II, Yoshitomi, Budziński, Fricke,
`Bottino II, Randolph,9
`Breivik II, Yoshitomi, Budziński, Fricke,
`Bottino II, Randolph, Sampalis I
`Pet. 11. Petitioner also relies on the Declaration testimony of Dr. Stephen J.
`Tallon (Ex. 1006).
`
`11, 12
`
`13–19
`
`103(a)
`
`103(a)
`
`
`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 ’046
`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 Yoshitomi et al., US 2003/0113432 A1, published June 19, 2003 (Ex.
`1033).
`5 Budziński, E., 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 Bottino, Lipid Composition of Two Species of Antarctic Krill: Euphausia
`superba and E. crystallorophias, 50B COMP. BIOCHEM. PHYSIOL. 479–
`484 (1975) (Ex. 1038).
`8 Sampalis et al., Evaluation of the Effects of Neptune Krill Oil™ on the
`Management of Premenstrual Syndrome and Dysmenorrhea, 8(2) ALT.
`MED. REV. 171–179 (2003) (Ex. 1012).
`9 Randolph et al., US 2005/0058728 A1, published Mar. 17, 2005
`(Ex. 1011).
`
`7
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`Patent 9,816,046 B2
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`II. ANALYSIS
`
`A. Claim Construction
`In this proceeding, the claims of the ’046 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)
`(2019). 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,” “polar solvent,” “astaxanthin esters,” “krill meal,” and “destroy the
`activity of lipases and phospholipases.” Pet. 32–38. 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).
`B. Obviousness of Claims 1–10 over Breivik II, Yoshitomi, Budziński,
`Fricke, Bottino II, and Sampalis I
`Petitioner contends that the subject matter of claims 1–10 would have
`been obvious over the combined disclosures of Breivik II, Yoshitomi,
`Budziński, Fricke, Bottino II, and Sampalis I. Pet. 41–57.
`
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`1. Breivik II10
`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 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
`the art to extract lipids from krill by either 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
`
`
`10 Petitioner contends that Breivik II is prior art to the ’046 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. 12–13 (citing Ex. 1006
`¶¶ 223–238).
`
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`Patent 9,816,046 B2
`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, 3:29–31.
`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 a pre-treatment step in which the raw
`material is heated at 80ºC for 5 minutes before the first wash with ethanol,
`which 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. Yoshitomi
`Yoshitomi discloses that krill lose freshness in a short period of time
`and that “shells of the heads and chests of krill are so vulnerable to external
`pressure that the krill are easily broken down upon impacts applied at the
`time of catching, whereupon the enzymes present in the internal organs flow
`out and decompose muscles.” Ex. 1033 ¶ 5. According to Yoshitomi, those
`enzymes must be disabled or inactivated when processing krill. Id. ¶ 6.
`Yoshitomi discloses the decomposition problem of krill is generally
`attributable to crushing of raw material into ground meat. Id. ¶ 37. In view
`of this, Yoshitomi describes chopping krill material into pieces and then
`placing the pieces into a heating and drying machine. Id. According to
`Yoshitomi, when krill is chopped into pieces and then boiled to disable
`
`10
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`Patent 9,816,046 B2
`enzymes, “a dried powdery and granular krill product” may be produced that
`“contains all components of krill and in which lipid degradation is
`sufficiently prevented.” Id. ¶¶ 2, 9, 22.
`3. Budziński
`Budziński “presents the current state of possible commercial-scale
`uses of krill-processing technologies,” including processing technologies for
`“human consumption, animal feed, and industrial purposes.” Ex. 1008,
`Abstract. Budziński explains that the “main difficulty in krill processing” is
`caused by proteolytic enzymes, such as lipases. Id. at 6.11 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 discloses 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.”), 27 (“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 also 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.
`
`
`11 Citations are to the original page numbers of the document that are
`centered at the top of each page.
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`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, which had been
`cooked on board “immediately after hauling,” showed a free fatty acid
`content that “was much lower, ranging from 1% to 3% of total lipids.” Id. at
`822–23.
`5. Bottino II
`Bottino II characterizes the lipids of two Antarctic euphausiids,
`Euphasia superba and Euphasia crystallorophias. Bottino II explains that
`“when one refers to Antarctic krill, one generally means Euphausia superba,
`which is the most abundant and far better known species of krill in the
`Antarctic Oceans.” Ex. 1038, 479.
`Bottino II describes a process wherein euphausiids were collected and,
`once on board the ship, the samples rapidly sorted by hand and extracted
`with a “chloroform:methanol (2:1, v/v) mixture.” Id. The fatty acid content
`of the krill product was then determined by gas-liquid chromatography. Id.
`at 480.
`
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`Table 2 of Bottino II is reproduced below.
`
`
`
`Ex. 1038, 481 (Table 2). Table 2 reports the identity and amount of each
`lipid present in the E. superba and E. crystallorophias samples obtained
`from various locations (i.e., stations) (analyzed as a weight percent of total
`lipids). Id. at 480–481. As shown in Table 2, the phosphatidylcholine
`content of krill obtained from Stations 11 and 13 was 48% and 46%,
`respectively, and the lysophosphatidylcholine (i.e., Lyso PC) content was
`1% in both samples. Id. at 481 (Table 2), 483.
`6. Sampalis I
`Sampalis I discloses the health benefits of Neptune krill oil, an
`encapsulated krill oil product, and 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.
`7. Analysis of Claim 1
`Claim 1 requires obtaining a krill meal by a process of treating krill to
`destroy the activity of lipases and phospholipases and then storing said krill
`for a period of from 1 to 36 months. Ex. 1001, 35:49–53. Petitioner
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`contends that Yoshitomi, Budzinski, Breivik II, and Fricke each describe
`treating krill to destroy or denature lipases and phospholipases. Pet. 42–44
`(citing Ex. 1033 ¶ 21; Ex. 1008, 12, 26; Ex. 1037, 3:33–4:6, 9:5–11; Ex.
`1010, 2–3; Ex. 1006 ¶¶ 416–419). Petitioner further contends that Budzinski
`discloses a denatured krill product that is “stable” and can be stored for at
`least 13 months without antioxidants and that Fricke describes lipid
`extraction from “processed krill that had been stored for a period of time.”
`Id. at 44 (citing Ex. 1008, 27–28, 30; Ex. 1010, 2–3; Ex. 1006 ¶¶ 420–423).
`Claim 1 also requires that krill oil be extracted from the stored krill
`product using a polar solvent and that the resulting krill oil have “greater
`than 30% phosphatidylcholine w/w of said krill oil and astaxanthin esters.”
`Ex. 1001, 35:54–57. Petitioner contends that Breivik II, Fricke, Bottino II,
`and Budzinski teach or suggest extracting krill oil with a polar solvent,
`Bottino II reports a krill oil extract with 48% phosphatidylcholine, and
`Breivik II describes a specific commercial krill oil formulation with more
`than 1,000 mg/kg esterified astaxanthin. Pet. 45–46 (citing Ex. 1038, 1–3;
`Ex. 1037, 9:5–11, 11:24–36; Ex. 1010, 2–3; Ex. 1008, 30).
`Petitioner contends one of ordinary skill in the art would have
`combined the various disclosures of Breivik II, Yoshitomi, Budziński,
`Fricke, Bottino II, and Sampalis I to arrive at the subject matter of claim 1
`because, among other reasons, these references relate to the same field of
`endeavor, it was well known in the art that destroying krill enzymes such as
`lipases and phospholipases would prevent spoilage, and the health benefits
`of phospholipids and astaxanthins were known in the art. Id. at 51–57.
`Upon review of Petitioner’s arguments and supporting evidence, we
`find that Petitioner sufficiently identifies where Breivik II, Yoshitomi,
`Budziński, Fricke, Bottino II, and Sampalis I teach or suggest every
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`limitation of claim 1, and provides an adequate explanation as to why one of
`ordinary skill in the art would have combined the various disclosures of
`these references to arrive at the subject matter of claim 1. Accordingly,
`based on the current record, Petitioner demonstrates a reasonable likelihood
`that claim 1 would have been obvious over the disclosures of Breivik II,
`Yoshitomi, Budziński, Fricke, Bottino II, and Sampalis I.
`8. Analysis of Claims 2–10
`Petitioner identifies where it contends Breivik II, Yoshitomi,
`Budziński, Fricke, Bottino II, and Sampalis I teach or suggest the subject
`matter of claims 2–10. In particular, Petitioner identifies where (1)
`Bottino II and Fricke describe a krill extract with less than 3% free fatty
`acids, as recited in claim 2 (Pet. 46–47 (citing Ex. 1038, 3; Ex. 1010, 2–3;
`Ex. 1006 ¶¶ 438–439)); (2) Bottino II describes a krill extract with less than
`2% lysophosphatidylcholine, as recited in claim 3 (id. at 47 (citing Ex. 1038,
`3; Ex. 1006 ¶¶ 440–441)); (3) Yoshitomi discloses grinding krill prior to
`destroying the activity of lipases and phospholipases, as recited in claim 4
`(id. at 47–48 (citing Ex. 1033 ¶¶ 9, 22, 32, 37, 41; Ex. 1006 ¶ 442));
`(4) Yoshitomi, Breivik II, Budzinski, and Fricke disclose, expressly or
`inherently, using heat to destroy or denature krill lipases and phospholipases,
`as recited in claim 5, and Breivik II discloses using chemicals to denature
`lipases and phospholipases, as recited in claim 6 (id. at 48–49 (citing
`Ex. 1033, Abstract; Ex. 1037, 3:33–4:2, 10:11–12; Ex. 1008, 24; Ex. 1010,
`2–3; Ex. 1006 ¶¶ 443–448)); (5) Breivik II discloses using both heat and
`chemicals to denature krill lipases and phospholipases, as recited in claim 7
`(id. at 49 (citing Ex. 1037, 3:33–4:6; Ex. 1006 ¶¶ 447–449)); (6) Sampalis I
`discloses a krill oil in an encapsulated dosage form, as recited in claim 8 (id.
`at 49–50 (citing Ex. 1012, 4; Ex. 1006 ¶ 451)); (7) Bottino II, Breivik II,
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`IPR2020-01533
`Patent 9,816,046 B2
`Yoshitomi, Fricke, and Budzinski disclose using Euphausia superba krill, as
`recited in claim 9 (id. at 50 (citing Ex. 1038, 1; Ex. 1037, 1:26–28, 7:30–
`9:11; Ex. 1033 ¶ 29; Ex. 1010, 1; Ex. 1008, 1, 3; Ex. 1006 ¶¶ 452–457)); and
`(8) Bottino II discloses a krill oil extract obtained from Euphausia superba
`that contained at least 40% phosphatidylcholine, as recited in claim 10 (id. at
`50–51 (citing Ex. 1038, Table 2; Ex. 1006 ¶ 459)).
`Upon review of Petitioner’s arguments and supporting evidence, we
`determine that, based on the current record, Petitioner demonstrates a
`reasonable likelihood that claims 2–10 would have been obvious over the
`disclosures of Breivik II, Yoshitomi, Budziński, Fricke, Bottino II, and
`Sampalis I.
`C. Obviousness of Claims 11 and 12 over Breivik II, Yoshitomi,
`Budziński, Fricke, Bottino II, and Randolph
`Claim 11 depends from claim 1 and further requires that the
`astaxanthin esters are present in the krill oil in an amount of at least
`100 mg/kg. Ex. 1001, 36:36–38. Claim 12 depends from claim 1 and
`further requires that the astaxanthin esters are present in the krill oil in an
`amount of at least 200 mg/kg. Id. at 36:39–41. Petitioner contends the
`subject matter of claims 11 and 12 would have been obvious over the
`combined disclosures of Breivik II, Yoshitomi, Budziński, Fricke, Bottino
`II, and Randolph. Pet. 57–59.
`1. Randolph
`Randolph discloses various 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.
`
`16
`
`
`
`IPR2020-01533
`Patent 9,816,046 B2
`¶¶ 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,” including capsules, soft gel
`capsules, tablets, gel tabs, lozenges, strips, granules, powders, concentrates,
`solutions, lotions, creams or suspensions. Id. ¶¶ 46, 52. Randolph further
`explains that a soft gel capsule of the composition can be manufactured to
`include about 300 mg of krill oil. Id. ¶ 52.
`2. Analysis of Claims 11 and 12
`Petitioner contends that Randolph discloses krill oil compositions
`containing between about 0.5 mg and about 50 mg astaxanthin and between
`about 300 mg and about 3000 mg krill oil. Pet. 57 (citing Ex. 1011 ¶¶ 40,
`44). Using the lower 0.5 mg astaxanthin value and the upper 0.003 kg (3000
`mg) value for krill oil, Dr. Tallon calculates that the krill oil compositions of
`Randolph may have the equivalent of 158 mg/kg astaxanthin ester. Id. at
`57–58 (citing Ex. 1006 ¶¶ 192, 469–470).
`Petitioner contends one of ordinary skill in the art would have
`combined the teachings of Randolph with those of Breivik II, Yoshitomi,
`Budziński, Fricke, and Bottino II because it was known in the art that
`astaxanthin and esterified astaxanthin in krill oil are associated with health
`benefits, and Randolph explains “how much desirable astaxanthin esters can
`be present in krill oil compositions.” Id. at 56, 59 (citing Ex. 1100, 1, 7;
`Ex. 1006 ¶¶ 69–70, 396–398, 471–473).
`
`17
`
`
`
`IPR2020-01533
`Patent 9,816,046 B2
`Given the disclosures of Randolph, and upon review of Petitioner’s
`arguments and the supporting testimony and calculations of Dr. Tallon, we
`determine that, based on the current record, Petitioner demonstrates a
`reasonable likelihood that claims 11 and 12 would have been obvious over
`the combined disclosures of Breivik II, Yoshitomi, Budziński, Fricke,
`Bottino II, and Randolph.
`D. Obviousness of Claims 13–19 over Breivik II, Yoshitomi, Budziński,
`Fricke, Bottino II, Randolph, and Sampalis I
`1. Analysis of Claim 13
`Claim 13 is similar to claim 1, but differs in requiring that the krill oil
`be derived from Euphausia superba krill meal, have “less than about 3%
`free fatty acids,” and have “at least 100 mg/kg astaxanthin esters.” Compare
`Ex. 1001, 35:48–57 with 36:42–56; Pet. 60. For the reasons discussed above
`with respect to claims 2, 9, and 11, Petitioner identifies where these
`limitations are disclosed by one or more of Breivik II, Yoshitomi, Budziński,
`Fricke, Bottino II, Randolph, and Sampalis I. Pet. 46–47, 50, 57–59, 61–64.
`Accordingly, based on the current record, Petitioner demonstrates a
`reasonable likelihood that claim 13 would have been obvious over these
`references.
`2. Analysis of Claims 14–19
`Claims 14–19 generally recite the same limitations as claims 4–10.
`See Pet. 64–66. Thus, for the reasons discussed above, and based on the
`current record, we determine that Petitioner demonstrates a reasonable
`likelihood that the subject matter of claims 14–19 would have been obvious
`over the combined disclosures of Breivik II, Yoshitomi, Budziński, Fricke,
`Bottino II, Randolph, and Sampalis I.
`
`18
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`
`IPR2020-01533
`Patent 9,816,046 B2
`
`III. CONCLUSION
`After considering the evidence and arguments presented in the
`Petition, we determine that, based on the current record, Petitioner
`demonstrates a reasonable likelihood that it would prevail in establishing
`that claims 1–19 of the ’046 patent are unpatentable on the grounds asserted
`in the Petition.
`
`IV. ORDER
`
`Accordingly, it is:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review is instituted with respect to claims 1–19 of the ’046 patent on the
`grounds asserted in the Petition; and
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 314(c) and 37
`C.F.R. § 42.4(b), notice is hereby given of the institution of a trial, which
`commences on the entry date of this decision.
`
`19
`
`
`
`IPR2020-01533
`Patent 9,816,046 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
`
`
`20
`
`
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