Trials@uspto.gov
`571-272-7822
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` Paper 7
` Entered: January 14, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`RIMFROST AS,
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`____________
`
`Case IPR2018-01178
`Patent 9,375,453 B2
`____________
`
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`571-272-7822
`
`
`
`
`
`
` Paper 7
` Entered: January 14, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`RIMFROST AS,
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`____________
`
`Case IPR2018-01178
`Patent 9,375,453 B2
`____________
`
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`IPR2018-01178
`Patent 9,375,453 B2
`
`
` INTRODUCTION
`Rimfrost AS (“Petitioner”) filed a Petition requesting an inter partes
`review of claims 1–32 of U.S. Patent No. 9,375,453 B2 (Ex. 1001, “the ’453
`patent”). Paper 2 (“Pet.”). Aker Biomarine Antarctic AS (“Patent Owner”)
`declined to file a Preliminary Response to the Petition.
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a). Upon considering the
`Petition, we determine that Petitioner has shown a reasonable likelihood that
`it would prevail in showing the unpatentability of at least one challenged
`claim. Accordingly, we institute an inter partes review of all challenged
`claims based upon all grounds raised in the Petition.
`Related Proceedings
`A.
`Petitioner and Patent Owner provide notice that two related patents,
`U.S. Patent Nos. 9,028,877 B2 (“the ’877 patent”) and 9,078,905 B2 (“the
`’905 patent”), have been asserted in Aker Biomarine Antarctic AS v. Olympic
`Holding AS, Case No. 1:16-CV-00035-LPS-CJB (D. Del.) (stayed). Pet. 2;
`Paper 4, 1. The parties note that the ’453 patent was asserted, along with
`related patents, in In the Matter of Certain Krill Oil Products and Krill Meal
`for Production of Krill Oil Products, Investigation No. 337-TA-1019
`(USITC). Id. According to the parties, that matter has been “effectively
`terminated.” Id.
` The Board has issued Final Written Decisions addressing challenges
`to claims of the ’877 patent (IPR2017-00746, Paper 23, claims 1–19 shown
`to be unpatentable; IPR2017-00748, Paper 23, claims 1–19 not shown to be
`unpatentable), and challenges to claims of the ’905 patent (IPR2017-00745,
`
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`Paper 24, claims 1–20 shown to be unpatentable; IPR2017-00747, Paper 24,
`claims 1–20 not shown to be unpatentable).
`Petitioner has concurrently filed a petition for inter partes review of
`claims 33–61 of the ’453 patent in IPR2018-01179.
`The ’453 Patent
`B.
`The ’453 patent describes extracts from Antarctic krill that include
`bioactive fatty acids. Ex. 1001, 1:19–20. The Specification states that the
`patent “discloses novel krill oil compositions having characterized by
`containing high levels of astaxanthin, phospholipids, includ[ing] enriched
`quantities of ether phospholipids, and omega-3 fatty acids.” Id. at 9:28–31.
`The ’453 patent 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.” Ex. 1001, 1:46–52. In
`addition, the ’453 patent recognizes that krill oil compositions, including
`compositions having up to 60% w/w phospholipid content and as much as
`35% w/w EPA/DHA content, were known in the art prior to the time of
`invention. Id. at 1:52–57. The ’453 patent also indicates that supercritical
`fluid extraction with solvent modifier was known to be a useful method for
`extracting marine phospholipids from salmon roe. Id. at 1:65–67.
`According to the ’453 patent, the solvent extraction methods used in
`the prior art to isolate krill oil from the krill “rely on the processing of frozen
`krill that are transported from the Southern Ocean to the processing site,”
`which transportation is expensive and may result in the degradation of the
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`krill starting material. Id. at 2:3‒6. Such methods have included steps of
`placing the material into a ketone solvent, such as acetone, to extract the
`lipid soluble fraction, and recovering the soluble lipid fraction from the solid
`contents using a solvent such as ethanol. Id. at 1:32‒40. To overcome the
`above limitations, the ’453 patent discloses “methods for processing freshly
`caught krill at the site of capture and preferably on board a ship.” Id. at
`10:18‒20.
`The ’453 patent describes producing krill oil by first subjecting the
`krill to a protein denaturation step to avoid the formation of enzymatically
`decomposed oil constituents. Id. at 9:43‒50. The Specification explains that
`the invention is “not limited to any particular method of protein
`denaturation. In some embodiments, the denaturation is accomplished by
`application of chemicals, heat, or combinations thereof.” Id. at 10:26‒31.
`The Specification describes an embodiment wherein the krill oil is
`subsequently extracted using, e.g., a polar solvent and use of supercritical
`carbon dioxide. Id. at 9:51‒54.
`In Example 7 of the ’453 patent, “[k]rill lipids were extracted from
`krill meal (a food grade powder) using supercritical fluid extraction with
`co-solvent.” Id. at 31:45‒46.
`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 31:47‒53.
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`
`Example 8 of the ’453 patent prepared krill oil using the same method
`described in Example 7, from the same krill meal used in that example.
`Ex. 1001, 32:16‒17. The krill oil was then analyzed using 31P NMR
`analysis to identify and quantify the phospholipids in the oil. Id. at 32:17‒
`19. Table 221 shows the phospholipid profiles for the raw material, the final
`product, and a commercially available krill oil, Neptune Krill Oil (“NKO”).
`Id. at 32:44‒47. Table 22 is reproduced below:
`
`Id. at 32:15‒39.
`The ’453 patent teaches that the “main polar ether lipids of the krill
`meal are alkylacylphosphatidylcholine (AAPC) at 7–9% of total polar lipids,
`
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`
` 1
`
` A reference in Example 8 of the ’453 patent to “table 25” (Ex. 1001, 32:45)
`appears to be a typographical error, as the Specification does not include a
`Table 25. We understand that reference to “table 25” to instead mean
`“Table 22,” which sets forth the relevant phospholipid profiles.
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`lyso-alkylacylphosphatidylcholine (LAAPC) at 1% of total polar lipids
`(TPL) and alkylacylphosphatidyl-ethanolamine (AAPE) at <1% of TPL.”
`Id. at 32:47–52.
`
`Illustrative Claim
`C.
`Of the challenged claims, claim 1, reproduced below, is the only
`independent claim and is illustrative of the claimed subject matter.
`1. A method of production of polar krill oil from Euphausia
`superba comprising:
`a) treating the Euphasia superba to denature lipases and
`phospholipases to provide a denatured krill product;
`b) contacting the denatured krill product with a polar solvent to
`extract a polar krill oil comprising phospholipids, said polar krill
`oil comprises greater than about 3% 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 greater than about 100
`mg/kg of said polar krill oil; and
`c) formulating said polar krill oil with a carrier for oral
`consumption.
`
`
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1–32 of the ’453
`patent on the following grounds:
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`
`Claim(s)
`1–3, 5–10, 12, 14–17, 19–20, 23–26, 28, 30–32
`
`4
`
`11, 18, 21, 27
`
`13, 22, 29
`
`Petitioner also relies upon the Declaration of Stephen J. Tallon, Ph.D.
`(Ex. 1006).
`
` ANALYSIS
`Claim Construction
`A.
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`
`
`
` 2
`
` Breivik, WO 2008/060163 A1, published May 22, 2008 (“Breivik II”)
`(Ex. 1037).
`3 Catchpole, WO 2007/123424, published Nov. 1, 2007 (“Catchpole) (Ex.
`1009).
`4 Bottino, Lipid Composition of Two Species of Antarctic Krill: Euphausia
`superba and E. crystallorophias, 50B COMP. BIOCHEM. PHYSIOL. 479–484
`(1975) (“Bottino II”) (Ex. 1038).
`5 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) (“Sampalis I”) (Ex. 1012).
`6 Sampalis, WO 03/011873 A2, published Feb. 13, 2003 (“Sampalis II) (Ex.
`1013).
`7 Fricke et al., Lipid, Sterol and Fatty Acid Composition of Antarctic Krill
`(Euphausia superba Dana), 19(11) LIPIDS 821–827 (1984) (“Fricke”)
`(Ex. 1010).
`8 Randolph, US 2005/0058728 A1, published Mar. 17, 2005 (“Randolph”)
`(Ex. 1011).
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`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016)
`(affirming applicability of broadest reasonable construction standard to inter
`partes review proceedings).9 Under that standard, and absent any special
`definitions, we give claim terms their ordinary and customary meaning, as
`would be understood by one of ordinary skill in the art at the time of the
`invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007); Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016)
`(“Under a broadest reasonable interpretation, words of the claim must be
`given their plain meaning, unless such meaning is inconsistent with the
`specification and prosecution history.”).
` Any special definitions for claim terms must be set forth with
`reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d
`1475, 1480 (Fed. Cir. 1994).
`Petitioner asserts proposed claim constructions for a number of claim
`terms. Pet. 16–32. We determine that construction of those claim terms are
`not necessary for purpose 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).
`
`
`
` 9
`
` The Office recently changed the claim construction standard to be
`employed in an inter partes review. See Changes to the Claim Construction
`Standard for Interpreting Claims in Trial Proceedings Before the Patent
`Trial and Appeal Board, 83 Fed. Reg. 51340 (October 11, 2018). However,
`based on the filing date of the Petition in this proceeding, the applicable
`claim construction standard remains as set forth in 37 C.F.R. § 42.100(b)
`(2016).
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`
`Level of Ordinary Skill in the Art
`B.
`The level of skill in the art is a factual determination that provides a
`primary guarantee of objectivity in an obviousness analysis. Al-Site Corp. v.
`VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950
`F.2d 714, 718 (Fed. Cir. 1991)).
`According to Petitioner, a person of ordinary skill in the art at the time
`of the invention would have
`held an advanced degree in marine sciences, biochemistry,
`organic (especially lipid) chemistry, chemical or process
`engineering, or associated sciences with complementary
`understanding, either through education or experience, of
`organic chemistry and in particular lipid chemistry, chemical or
`process engineering, marine biology, nutrition, or associated
`sciences; and knowledge of or experience in the field of
`extraction. In addition, a POSITA would have had at least five
`years applied experience.
`Pet. 6 (citing Ex. 1006 ¶¶ 30–31).
` At this stage in the proceeding, we determine that Petitioner’s
`description of the level of ordinary skill in the art is sufficiently supported by
`the current record. Moreover, we have reviewed the credentials of Dr.
`Tallon and, at this stage in the proceeding, consider him to be qualified to
`provide his opinion on the level of skill and the knowledge of a person of
`ordinary skill in the art at the time of the invention. We also note that the
`applied prior art reflects the appropriate level of skill at the time of the
`claimed invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
`Cir. 2001).
`
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`
`C. Obviousness over Breivik II, Catchpole, Bottino II, and Sampalis I
`Petitioner asserts that claims 1–3, 5–10, 12, 14–17, 19–20, 23–26, 28,
`and 30–32 would have been obvious over the combined teachings of
`Breivik II, Catchpole, Bottino II, and Sampalis I. Pet. 33–56.
`1. Breivik II
`Breivik II “relates to a process for preparing a substantially total lipid
`fraction from fresh krill, and a process for separating phospholipids from the
`other lipids.” Ex. 1037, 1:8–10.10 According to Breivik II, approximately
`50% of the lipids in E. superba are phospholipids, and oil extracted from E.
`superba contains lower amounts of environmental pollutants than traditional
`fish oils. Id. at 1:32–33, 2:3–4. Breivik II explains that krill lipases remain
`active after the krill is dead, and, thus, krill oil may contain an undesired
`amount of free fatty acids, making it desirable to use a process that will
`provide for a low degree of hydrolysis of the krill lipids. Id. at 2:6–13.
`Breivik II teaches that its extraction process provides a substantially
`total lipid fraction from fresh krill, without using organic solvents like
`acetone. Id. at 3:29–31. That lipid fraction contains triglycerides,
`astaxanthin and phospholipids. Id. at 3:19–20. According to Breivik II, the
`process includes an optional heat pre-treatment of the krill to inactivate
`enzymatic decomposition of the lipids, ensuring a product with a low level
`of free fatty acids. Id. at 4:3–6.
`Breivik II describes an extraction process in which fresh krill is
`washed with ethanol, and the ethanol washed krill is then extracted with
`
`
`
`10 Unless otherwise noted, the cited page numbers refer to those supplied by
`the original reference, and not the page numbers added by Petitioner.
`
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`supercritical CO2 containing 10% ethanol. Id. at 7:31–8:3 (Example 2).
`Breivik II also discloses a process in which the raw material is pre-treated
`with heat at 80ºC for 5 minutes before the first wash with ethanol. Id. at
`9:5–11 (Example 6). According to Breivik II, “heat-treatment gives an
`increased yield of lipids compared to the same treatment with no heating.”
`Id. at 9:33–34.
`Breivik II explains that “[a] lipid fraction or lipid product, derived
`from the process according to the invention may have some additional
`advantages related to quality compared to known krill oil products
`(produced by conventional processes), such as for instance a krill oil from
`Neptune Biotechnologies & Bioresources extracted from a Japanese krill
`source (species not specified)” having ≥ 40.0% total phospholipids and ≥ 1.0
`mg/g esterified astaxanthin. Id. at 11:23–36. Breivik II states that a lipid
`fraction or product according to the invention would be expected, among
`other things, to “contain substantially less hydrolysed and/or oxidised lipids
`than lipid produced by conventional processes” and have “less deterioration
`of the krill lipid antioxidants from conventional processing.” Id. at 12:1–9.
`2. Catchpole
`Catchpole discloses “a process for separating lipid materials
`containing phospholipids,” Ex. 1009, 1:5–6, in order to produce a product
`containing “desirable levels of particular phospholipids,” id. at 3:27–28.
`Catchpole states 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, anti-
`cancer activity, alleviation of arthritis, improvement of cardiovascular
`health, and treatment of metabolic syndromes. They can also be used in
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`sports nutrition.” Id. at 1:29–2:2. Catchpole further discloses 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.
`Catchpole describes, in Example 18, the fractionation of krill lipids
`from krill powder using a process that employs supercritical CO2 in a first
`extraction, and a CO2 and absolute ethanol mixture in a second. Id. at 24:1–
`16. Table 16, reproduced below, reports the phospholipid concentrations
`present in the krill oil extract obtained by Catchpole. Id. at Table 16.
`
`
`
`As shown in Table 16, the composition of Extract 2 includes 39.8%
`phosphatidylcholine (“PC”). Id. The ether phospholipids
`alkylacylphosphatidylcholine (“AAPC”) and alkylacylphosphatidyl-
`ethanolamine (“AAPE”) were also present in Extract 2, representing 4.6%
`and 0.2%, respectively, of the extracted composition. Id. In addition,
`summing each of the reported phospholipid amounts reported for Extract 2
`yields a total phospholipid concentration of 45.1%. Id.
`3. Bottino II
`Bottino II characterizes the lipids of two Antarctic euphausiids,
`Euphasia supercar and Euphasia crystallorophias. Bottino II explains,
`“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.
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`Bottino II explains that the euphausiids were collected and, once on
`board the ship, the samples were rapidly sorted by hand and extracted with a
`“chloroform:methanol (2:1, v/v) mixture.” Id. Fatty acid compositions were
`determined by gas-liquid chromatography. Id. at 480.
`Table 1 of Bottino II is reproduced below.
`
`
`Ex. 1038, Table 1. Table 1 discloses the fatty acid content of E. superba and
`E. crystallorophias obtained from different locations (i.e., stations) as a
`weight percent of total fatty acids. Id. at 480.
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`Table 2 of Bottino II is reproduced below.
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`
`
`Ex. 1038, Table 2. Table 2 reports the identity and amount of each lipid
`present in the E. superba and E. crystallorophias samples analyzed as a
`weight percent of total lipids. Id. at 480–481.
`4. Sampalis I
`Sampalis I describes a clinical trial “[t]o evaluate the effectiveness of
`Neptune Krill OilTM (NKOTM) for the management of premenstrual
`syndrome and dysmenorrhea.” Ex. 1012, 171. Sampalis I explains that
`NKO is “extracted from Antarctic krill also known as Euphausia superba.
`Euphausia superba, a zooplankton crustacean, is rich in phospholipids and
`triglycerides carrying long-chain omega-3 polyunsaturated fatty acids,
`mainly EPA and DHA, and in various potent antioxidants including vitamins
`A and E, astaxanthin, and a novel flavonoid.” Id. at 174.
`Sampalis I discloses that each patient in the clinical trial was “asked to
`take two 1-gram soft gels of either NKO or omega-3 18:12 fish oil (fish oil
`containing 18% EPA and 12% DHA) once daily with meals during the first
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`month of the trial.” Id. Sampalis I reports that “[t]he final results of the
`present study suggest within a high level of confidence that Neptune Krill
`Oil can significantly reduce the physical and emotional symptoms related to
`premenstrual syndrome, and is significantly more effective for the
`management of dysmenorrhea and emotional premenstrual symptoms than
`fish oil.” Id. at 178.
`
`5. Analysis
` A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). “An obviousness determination requires finding both ‘that a skilled
`artisan would have been motivated to combine the teachings of the prior art
`references to achieve the claimed invention, and that the skilled artisan
`would have had a reasonable expectation of success in doing so.’” CRFD
`Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–
`1368 (Fed. Cir. 2016)). “The reasonable expectation of success requirement
`refers to the likelihood of success in combining references to meet the
`limitations of the claimed invention.” Intelligent Bio-Sys., Inc., 821 F.3d at
`1367. A reasonable expectation of success “does not require absolute
`predictability of success . . . all that is required is a reasonable expectation
`of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (quoting In
`re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988)).
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`
`Petitioner asserts that the method of independent claim 1 would have
`been obvious to a person of skill in the art over the combined teachings of
`Breivik II, Catchpole, Bottino II, and Sampalis I. Pet. 33–44. To begin,
`Petitioner asserts that Breivik II teaches a method of producing polar krill oil
`from E. superba because the reference is directed to “preparing a
`substantially total lipid extract from fresh krill,” and explains that “[t]he
`current greatest potential for commercial utilisation is the Antarctic
`Euphausia superba.” Pet. 34 (quoting Ex. 1037, 1:25–28). Petitioner also
`references an example in Breivik II describing the extraction of lipids from
`fresh E. superba. Id. at 36–37 (citing Breivik II Example 6).
`Petitioner asserts that Breivik II describes the “application of heat to
`denature krill resulting in a denatured krill product,” as required by claim 1,
`by teaching, among other things, an “optional pre-treatment involving short-
`term heating of the fresh krill will also give an inactivation of enzymatic
`decomposition of the lipids, thus ensuring a product with very low levels of
`free fatty acids.” Id. at 35 (citing Ex. 1037, 4:3–6, 9:5–6, 10:6–8 and 11–
`12). Dr. Tallon explains that, in Brevik II, heating the fresh krill inactivates
`the krill’s enzymes, including lipases, thereby preventing decomposition of
`the krill lipids. Ex. 1006 ¶ 196.
`As for the next claimed step of contacting the denatured krill product
`with a polar solvent to extract polar krill oil, Petitioner asserts that such
`process was well known in the art at the time of the invention and Breivik II
`expressly discloses this processing step for E. superba by teaching an
`extraction step at supercritical pressure using CO2 containing 10% ethanol,
`and isolating the lipid fraction from the ethanol. Pet. 35–36 (citing Ex.
`1037, 4:28–33). As further support, Petitioner also refers to Breivik II’s
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`example using a “[s]upercritical fluid extraction with CO2 containing 10%
`ethanol.” Id. at 36–37 (quoting Ex. 1037, 9:5–8).
`For the last step of the claimed method requiring formulating the polar
`krill oil with a carrier for oral consumption, Petitioner asserts that “[t]he
`prior art expressly discloses the formulation of krill oil in capsule and soft
`get capsule dosage forms suitable for oral administration.” Pet. 37. As an
`example, Petitioner refers to a disclosure in Sampalis I of administering krill
`oil to patients in the form of a soft gel. Id. at 37–38 (citing Ex. 1012, 4).
`With respect to the recited composition of the extracted krill oil in
`claim 1, Petitioner and Dr. Tallon assert that “each of the recited constituents
`is naturally present in live krill, and were known to be present in lipid
`fractions extracted from krill using conventional extraction techniques and
`solvents.” Pet. 38 (citing Ex. 1006 ¶¶ 102, 106, and 110). In support of that
`position, Petitioner and Dr. Tallon refer to Catchpole. In particular, for the
`recitation that the polar krill oil comprises “greater than about 3% ether
`phospholipids,” Petitioner and Dr. Tallon assert that Catchpole is directed to
`methods for separating lipid materials from materials, including krill, and
`describes the extracted phospholipids as being “implicated in conferring a
`number of health benefits.” Id. at 39 (citing Ex. 1006 ¶¶ 214–225, Ex. 1009,
`1:29–2:2, 7:5–6, 24:1–9).
`More particularly, Petitioner and Dr. Tallon rely upon Catchpole’s
`disclosure in Example 18 of the fractionation of krill lipids from krill
`powder, and the reported concentrations of extracted phospholipids in Table
`16. Pet. 40 (citing Ex. 1006 ¶¶ 219–225, Ex. 1009, 24:1–19). Dr. Tallon
`explains that the ether phospholipids fractions analyzed were alkylacyl-
`phosphatidylcholine (AAPC) and alkylacylphospatidylethanolamine
`
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`17
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`(AAPE). Ex. 1006 ¶¶ 221–222; Ex. 1009, 14:7–11. Petitioner and Dr.
`Tallon draw our attention to the composition of Extract 2 in Table 16
`reported as having 4.8% ether phospholipids (4.6% AAPC and 0.2%
`AAPE), thus comprising greater than about 3% ether phospholipids as
`required by claim 1. Pet. 43.
`
`Petitioner and Dr. Tallon also refer to Catchpole’s Extract 2 in
`Example 18 as disclosing “from about 27% to 50% w/w non-ether
`phospholipids so that the amount of total phospholipids in the krill oil is
`from about 30% to 60% [w/w],” as required in claim 1. Pet. 41–42 (citing
`Ex. 1006 ¶¶ 219–225, 414, Ex. 1009, 24). Specifically, they rely upon
`Catchpole’s disclosure in Table 16 that Extract 2 has 45.1% total
`phospholipids (39.8% PC, 0.3% PE, 0.2% CL, 4.6% AAPC, 0.2% AAPE),
`and thus, has 40.3% non-ether phospholipids by deduction, i.e., total
`phospholipids (45.1%) minus ether phospholipids (4.8%). Id. at 42 (citing
`Ex. 1006 ¶¶ 212–225, 414).
`Concerning the claim 1 recitation that the krill extract include “from
`about 20% to 50% triglycerides w/w of said polar krill oil,” Petitioner asserts
`that “[i]t would have been recognized that triglycerides represent one of the
`most abundant constituents in krill oil, and a POSITA would have [] looked
`to other polar krill extracts for the relative amount present.” Pet. 42 (citing
`Ex. 1006 ¶¶ 100, 414). As an example of such relative amounts, Petitioner
`and Dr. Tallon refer to the details provided in Bottino II’s study of the lipids
`extracted from two species of Antarctic krill, including E. superba, using a
`polar solvent. Id. (citing Ex. 1038, 479–482). According to Petitioner and
`Dr. Tallon, Bottino’s report that “in Euphausia superba the complex lipids
`were mostly phosphatidylcholine at 48-49%, followed by triglycerides at
`
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`36%” demonstrates that it was known in the art at the time of the invention
`that “oil extracted from krill using conventional solvent extraction
`techniques and solvents contained triglyceride levels within 20%-50% the
`limitation of claim 1.” Id. at 42–43 (quoting Ex. 1006 ¶¶ 182–187 and citing
`Ex. 1038, 481 (Table 2) and 479–482)).
`Claim 1 also requires “astaxanthin esters in amount of greater than
`about 100 mg/kg of said polar krill oil.” For this element, Petitioner relies
`upon Breivik II’s disclosure that “Neptune’s commercial krill oil product has
`≥ 40% total phospholipids and ≥ 1.0 mg/g esterified astaxanthin (i.e., ≥ 1000
`mg/kg).” Pet. 43. Based on that disclosure, Petitioner asserts that “the
`astaxanthin element of claim 1 is expressly disclosed in the prior art.” Id.
`
`According to Petitioner, the ordinary artisan would have had a reason
`to combine the teachings of Breivik II, Catchpole, Bottino II and Sampalis I
`because they each relate to the same field of endeavor, i.e., extracting krill
`oil using conventional polar solvents and extraction techniques,
`characterizing krill oil components, and discussing health benefits associated
`with such components. See Pet. 53–55. For example, Petitioner notes that
`Breivik II and Catchpole disclose methods of such extraction, Catchpole
`discloses phospholipid and triglyceride contents of polar krill oil, Bottino II
`discloses the esterified astaxanthin content of a commercial krill oil, and
`Sampalis I discloses polar krill oil formulated for oral consumption. Id.
`According to Petitioner,
`Thus, a POSITA, following the treatment and extraction steps
`taught by Breivik II, would have been motivated to look to
`other references such as Catchpole and Bottino II to ascertain
`the other constituents naturally present in the krill oil extracts
`and their respective amounts, and to administer the resulting
`
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`polar krill oil in the form of a soft-gel capsule as taught by
`Sampalis I.
`Pet. 56 (citing Ex. 1006 ¶¶ 85–110, 438). Based on the prior art teachings,
`Petitioner asserts that the ordinarily skilled artisan would have also had a
`“reasonable expectation of producing a polar krill oil having the percentage
`of constituents as recited in the claims.” Id. at 53.
`Likewise, Dr. Tallon testifies that a person of ordinary skill in the art
`“would have known that the relative proportions of the natural krill and
`hence the natural krill oil constituents could be varied in predictable ways by
`applying a single solvent or combination of solvents . . . to selectively
`extract specific groups of lipid components . . ., and by blending these
`selective extracts in known and predictable ways to produce a desired krill
`oil composition,” indicating that an ordinarily skilled artisan would have had
`a reason to combine the teachings of the cited references and a reasonable
`expectation of success in doing so in a manner that yields the claimed
`invention. Ex. 1006 ¶ 104.
`
`Based upon our review of the current record, we determine that
`Petitioner’s characterization of Breivik II, Catchpole, Bottino II, and
`Sampalis I, as well as Dr. Tallon’s testimony as to the knowledge in the art
`are adequately supported in terms of demonstrating that Breivik II teaches or
`suggests the claimed method steps for producing polar krill oil from E.
`superba by providing a denatured krill product and extracting polar krill oil
`from that product using a polar solvent, Catchpole disclosed the components
`of polar krill oil and the amounts thereof, Bottino II discloses the triglyceride
`content of polar krill oil, and Sampalis I discloses polar krill oil formulated
`for oral consumption.
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`Based on the current record, we do not agree with Petitioner’s
`
`assertion that Breivik II “expressly disclosed” the claim element requiring
`the polar krill oil from E. superba to comprise astaxanthin esters in an
`amount of greater than about 100 mg/kg. Pet. 43. For that assertion,
`Petitioner relies upon a disclosure in Breivik II relating to a commercial krill
`oil from Neptune Biotechnologies & Bioresources containing ≥ 40% total
`phospholipids and ≥ 1.0 mg/g esterified astaxanthin (i.e., ≥ 1000 mg/kg). Id.
`(citing (Ex. 1037, 11:23–30). While the amount of astaxanthin in the
`Neptune krill oil appears to be more than adequate to meet the claim
`recitation, we note that Breivik II describes that particular Neptune krill oil
`as “extracted from Japanese krill source (species not specified).” Ex. 1037,
`11:25–27. Thus, at this stage in the proceeding, based on the current record,
`we are unable to appreciate that the Neptune krill oil is
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