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`280. The Fricke Article discloses a krill extract, as recited in claim 1 of the
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`
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`‘351 patent. See, e.g.: “The lipid classes, fatty acids of total and individual lipids
`
`and sterols of Antarctic krill (Euphausia superba Dana) from two areas of the
`
`Antarctic Ocean were analyzed by thin layer chromatography (TLC), gas liquid
`
`chromatography (GLC) and gas liquid chromatography /mass spectrometry
`
`(GLC/MS).” See Ex. 1006 at p. 821 “Krill samples of 5 kg were quick-frozen and
`
`stored at -35 C until analyzed. Subsamples prepared from the core of the 5 kg
`
`samples were homogenized in a mortar under liquid nitrogen, and lipid extraction
`
`was performed according to Folch et al. Lipids were dissolved in dichloromethane:
`
`methanol 1:1 (v/v) and stored under a nitrogen atmosphere at -23 C.” See Ex. 1006
`
`at p. 821. The Fricke Article discloses the claimed phospholipid. The claimed
`
`phospholipid would necessarily be present in the total lipid extraction of krill
`
`performed in the Fricke Article. Further, to the extent the ‘351 patent discloses the
`
`claimed phospholipid, so does the Fricke Article. See, e.g.: “The positional
`
`analysis of the fatty acids in the main phospholipids PC and PE (Table 6) shows
`
`that saturated fatty acids are commonly linked to the sn-1 position and that the sn-2
`
`position is preferred by unsaturated fatty acids. In this respect krill has the same
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`
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`280. The Fricke Article discloses a krill extract, as recited in claim 1 of the
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`
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`‘351 patent. See, e.g.: “The lipid classes, fatty acids of total and individual lipids
`
`and sterols of Antarctic krill (Euphausia superba Dana) from two areas of the
`
`Antarctic Ocean were analyzed by thin layer chromatography (TLC), gas liquid
`
`chromatography (GLC) and gas liquid chromatography /mass spectrometry
`
`(GLC/MS).” See Ex. 1006 at p. 821 “Krill samples of 5 kg were quick-frozen and
`
`stored at -35 C until analyzed. Subsamples prepared from the core of the 5 kg
`
`samples were homogenized in a mortar under liquid nitrogen, and lipid extraction
`
`was performed according to Folch et al. Lipids were dissolved in dichloromethane:
`
`methanol 1:1 (v/v) and stored under a nitrogen atmosphere at -23 C.” See Ex. 1006
`
`at p. 821. The Fricke Article discloses the claimed phospholipid. The claimed
`
`phospholipid would necessarily be present in the total lipid extraction of krill
`
`performed in the Fricke Article. Further, to the extent the ‘351 patent discloses the
`
`claimed phospholipid, so does the Fricke Article. See, e.g.: “The positional
`
`analysis of the fatty acids in the main phospholipids PC and PE (Table 6) shows
`
`that saturated fatty acids are commonly linked to the sn-1 position and that the sn-2
`
`position is preferred by unsaturated fatty acids. In this respect krill has the same
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`
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`fatty acid distribution as other marine animals (41).” See Ex. 1006 at p. 826, Table
`
`6
`
`
`
`281. The Fricke Article discloses a krill extract that is suitable for human
`
`consumption. See, e.g.: “Krill samples of 5 kg were quick-frozen and stored at -35
`
`C until analyzed. Subsamples prepared from the core of the 5 kg samples were
`
`homogenized in a mortar under liquid nitrogen, and lipid extraction was performed
`
`according to Folch et al. (15). Lipids were dissolved in dichloromethane: methanol
`
`1:1 (v/v) and stored under a nitrogen atmosphere at -23 C.” See Fricke at p. 821. It
`
`follows from the passage above that those performing the analyses described in the
`
`Fricke Article necessarily evaporated the solvents used for extraction before
`
`conducting such analyses – leaving behind an extract suitable for human
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`consumption.
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`152
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`282. The Fricke Article discloses a krill extract that has a total
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`
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`phospholipid concentration in an amount of about 40% w/w, wherein about
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`represents ±10%, as recited in claim 2 of the ‘351 patent. See, e.g.: “Euphausia
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`superba is extremely rich in phospholipids (>40% of total lipids)…” Ex., 1006 at p.
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`822, see also Table 1.
`
`
`
`283. The Fricke Article discloses a krill extract that has a total
`
`phospholipid concentration in an amount of about 45% w/w, wherein about
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`represents ±20%, as recited in claim 3 of the ‘351 patent. See, e.g.: “Euphausia
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`153
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`superba is extremely rich in phospholipids (>40% of total lipids)…” Ex. 1006 at p.
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`822, see also Table 1.
`
`284. The Fricke Article discloses a krill extract that further comprises an
`
`additional lipid, including monoglycerides, triglycerides, and free fatty acids, as
`
`recited in claim 4 of the ‘351 patent. See Ex. 1006 at p. 822, see also Table 1.
`
`285. The Fricke Article discloses a krill extract that has a concentration of
`
`free fatty acids of about 5% w/w of the lipids in the extract, as recited in claim 5 of
`
`the ‘351 patent. See, e.g.: “Samples of the same haul which were cooked on board
`
`immediately after hauling and stored under the same conditions showed a FFA
`
`content which was much lower, ranging from 1% to 3% of total lipids.” Ex. 1006
`
`at p. 822, see also Table 1.
`
`286. The Fricke Article discloses a krill extract wherein the extract further
`
`comprises polyunsaturated fatty acids which comprise at least 15% w/w of the
`
`lipids in the extract. See, e.g.: “The composition of the fatty acids of total lipids of
`
`Euphausia superba is similar to that of other marine crustaceans and some marine
`
`fishes (29) (Tables 2 and 3). The main fatty acids are 14:0 (11-15%), 16:0 (26-
`
`32%), 16:1(n-7) (7%), 18:1(n-9) (10%), 18:1(n-7) (8%), 20:5(n-3) (8-13%) and
`
`22:6(n-3) (3-5%).” Ex. 1006 at p. 823, see also Table 2.
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`287. The Fricke Article discloses a krill extract wherein the extract further
`
`comprises polyunsaturated fatty acids which comprise at least 15% w/w of the
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`lipids in the extract, and wherein the polyunsaturated fatty acids are omega-3 fatty
`
`acids, as recited in claim 9 of the ‘351 patent. See, e.g.: “The composition of the
`
`fatty acids of total lipids of Euphausia superba is similar to that of other marine
`
`crustaceans and some marine fishes (29)(Tables 2 and 3). The main fatty acids are
`
`14:0 (11-15%), 16:0 (26-32%), 16:1(n-7) (7%), 18:1(n-9) (10%), 18:1(n-7) (8%),
`
`20:5(n-3) (8-13%) and 22:6(n-3) (3-5%).” Ex. 1006 at p. 823, see also Table 2.
`
`288. The Fricke Article discloses the claimed phospholipid, wherein one of
`
`R1 and R2 is EPA and the other is DHA, as recited in claim 19 of the ‘351 patent.
`
`The claimed phospholipid, wherein one of R1 and R2 is EPA and the other is
`
`DHA, would necessarily be present in the total lipid extraction of krill performed
`
`in the Fricke Article. Further, to the extent the ‘351 patent discloses the claimed
`
`phospholipid, wherein one of R1 and R2 is EPA and the other is DHA, so does the
`
`Fricke Article. See, e.g.: “The positional analysis of the fatty acids in the main
`
`phospholipids PC and PE (Table 6) shows that saturated fatty acids are commonly
`
`linked to the sn-1 position and that the sn-2 position is preferred by unsaturated
`
`fatty acids. In this respect krill has the same fatty acid distribution as other marine
`
`animals (41).” Ex. 1006 at p. 826, see also Table 6. As additional evidence, Le
`
`Grandois demonstrates that krill oil extracted by the Folch method contained PC-
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`EPA/EPA, PC-DHA/DHA and PC-EPA/DHA. Ex. 1013, p. 6018, Table 2
`
`
`
`289. The Fricke Article discloses the claimed phospholipid, wherein R1
`
`and R2 is EPA, as recited in claim 20 of the ‘351 patent. The claimed
`
`phospholipid, wherein R1 and R2 is EPA, would necessarily be present in the total
`
`lipid extraction of krill performed in the Fricke Article. Further, to the extent the
`
`‘351 patent discloses the claimed phospholipid, wherein R1 and R2 is EPA, so
`
`does the Fricke Article. See, e.g.: “The positional analysis of the fatty acids in the
`
`main phospholipids PC and PE (Table 6) shows that saturated fatty acids are
`
`commonly linked to the sn-1 position and that the sn-2 position is preferred by
`
`unsaturated fatty acids. In this respect krill has the same fatty acid distribution as
`
`other marine animals (41).” Ex. 1006 at p. 826, see also Table 6. As additional
`
`evidence, Le Grandois demonstrates that krill oil extracted by the Folch method
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`contained PC-EPA/EPA, PC-DHA/DHA and PC-EPA/DHA. Ex. 1013, p. 6018,
`
`Table 2
`
`290. The Fricke Article discloses the claimed phospholipid, wherein R1
`
`and R2 is DHA, as recited in claim 21 of the ‘351 patent. The claimed
`
`phospholipid, wherein R1 and R2 is DHA, would necessarily be present in the total
`
`lipid extraction of krill performed in the Fricke Article. Further, to the extent the
`
`‘351 patent discloses the claimed phospholipid, wherein R1 and R2 is DHA, so
`
`does the Fricke Article. See e.g.: “The positional analysis of the fatty acids in the
`
`main phospholipids PC and PE (Table 6) shows that saturated fatty acids are
`
`commonly linked to the sn-1 position and that the sn-2 position is preferred by
`
`unsaturated fatty acids. In this respect krill has the same fatty acid distribution as
`
`other marine animals (41).” Ex. 1006 at p. 823, see also Table 6. As additional
`
`evidence, Le Grandois demonstrates that krill oil extracted by the Folch method
`
`contained PC-EPA/EPA, PC-DHA/DHA and PC-EPA/DHA. Ex. 1013, p. 6018,
`
`Table 2.
`
`291. The Fricke Article discloses a krill extract comprising an antioxidant,
`
`i.e., a carotenoid, as recited in claim 22 of the ‘351 patent. Ex. 1006 at p. 822,
`
`Table 1.
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`157
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`292. The Fricke Article discloses a krill extract comprising a carotenoid, as
`
`
`
`recited in claim 23 of the ‘351 patent. Ex. 1006 at p. 822, Table 1. Astaxanthin,
`
`which is a carotenoid, is naturally present in krill lipid extracts.
`
`293. The Fricke Article discloses at least a solution and/or a syrup
`
`comprising a krill extract, as recited in claim 24 of the ‘351 patent. One of ordinary
`
`skill in art would understand that a krill oil extract is a solution. The Fricke Article
`
`discloses a krill extract suitable for human consumption that comprises the claimed
`
`phospholipid. See, ¶¶280-281, supra.
`
`294. Claims 25-30, 33, and 42-46 of the ‘351 patent are identical to claims
`
`2-6, 9, and 19-23 of the ‘351 patent. See ¶¶282-292, supra.
`
`295. The Fricke Article discloses food, beverage, energy bar, or nutritional
`
`supplement comprising a krill extract, as recited in claim 47 of the ‘351 patent.
`
`One of ordinary skill in art would understand that a krill extract suitable for human
`
`consumption could be used in or as a food. The Fricke Article discloses a krill
`
`extract suitable for human consumption that comprises the claimed phospholipid.
`
`See, ¶¶280-281, supra.
`
`296. Claims 48-53, 56, and 65-69 of the ‘351 patent are identical to claims
`
`2-6, 9, and 19-23 of the ‘351 patent. See ¶¶282-292, supra.
`
`297. The Fricke Article discloses a cosmetic preparation comprising a krill
`
`extract, as recited in claim 70 of the ‘351 patent. The person of ordinary skill in the
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`art would understand that a krill oil safe for human consumption could be used as a
`
`“cosmetic preparation.” The Fricke Article discloses a krill extract suitable for
`
`human consumption that comprises the claimed phospholipid. See, ¶¶280-281,
`
`supra.
`
`298. The Fricke Article discloses the embodiment wherein the topical
`
`cosmetic product is one or more of a moisturizing cream and a sun-block product,
`
`as recited in claim 71 of the ‘351 patent. The person of ordinary skill in the art
`
`would understand that a krill oil safe for human consumption could be used as a
`
`“moisturizing cream.”
`
`299. Claims 72-74, 76-77, and 89-93 of the ‘351 patent are identical to
`
`claims 2-4, 6, 9-10, and 19-23 of the ‘351 patent. See ¶¶282-292, supra.
`
`300. The Fricke Article discloses an Antarctic krill extract suitable for
`
`human consumption that comprises the claimed phospholipid. See, ¶¶280-281,
`
`supra. The Fricke Article inherently discloses the embodiments where the extract is
`
`extracted under conditions suitable for preserving an effective amount of a
`
`phospholipid having two independently selected fatty acid chains within the same
`
`molecule selected from EPA and DHA. The Fricke Article describes a krill extract
`
`comprising phospholipids in an amount of at least 40% w/w, See Ex. 1006 at p.
`
`822, Table 1. The Fricke Article describes a krill extract comprising omega-3 fatty
`
`acids in an amount of at least 15% w/w. See Ex. 1006 at p. 823, Table 2. The
`159
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`Fricke Article describes a krill extract comprising a carotenoid (e.g., astaxanthin,
`
`which occurs naturally in krill and krill extracts). See Ex. 1006 at p. 821, Table 1.
`
`4.1.1.5.
`
`The Fujita Reference
`
`301. The Fisheries Agency, General Report on Research and Development
`
`of Techniques in Processing and Utilization of Marine Products (March 1985) (the
`
`“General Report”) is a published compilation of studies and other research on
`
`marine products-related topics.
`
`302. The General Report is divided into multiple sections, including
`
`Section II, which is focused on the development of krill as a food product. Section
`
`II, Chapter 6 (pp. 273-307), entitled “Development of utilization technology of a
`
`valuable resource (astaxanthin) in krill,” was written by Takao Fujita (the “Fujita
`
`Reference”).
`
`303. I understand that the General Report, including the Fujita Reference,
`
`was published in March 1985 and has been publicly accessible since November
`
`1986. See Welch declaration (Ex. 1043) at ¶¶ 25-44; see also Van Breemen
`
`Declaration (Ex. 1040) at ¶¶ 36-40. Therefore, I understand that it is prior art to
`
`the ‘351 Patent under at least 35 U.S.C. § 102(b), even under Complainants’
`
`earliest alleged priority date. This reference was not of record during prosecution
`
`of the ‘351 Patent.
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`
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`160
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`304. The Fujita Reference describes testing related to several different
`
`
`
`extractions of krill meal. Ex. 1005 at 277-78. The krill meal used for such testing
`
`was “commercially available meal that was manufactured at a trawler De Laval-
`
`type meal plant and then transported within a freezer.” Id. at p. 276. Multiple
`
`solvents were investigated, including hexane, ethanol, and acetone, all organic
`
`solvents that can be “used in food products.” Id. Multiple extractions methods
`
`were also investigated, including (i) dip/agitation-type extraction (Id. at p. 277);
`
`and (ii) once-through extraction (Id. at pp. 277-278.).
`
`305. The Fujita Reference also describes the testing of krill extracts for use
`
`in food products. Id. at p. 279. Krill extracts were added to a variety of food
`
`products, including fish cakes, rice crackers, and butter cream, so that they could
`
`tested for taste and color. Id.
`
`306. The Fujita Reference discloses a krill extract, as recited in claim 1 of
`
`the ‘351 Patent. See, e.g.,: “The objective of this research is to investigate the
`
`development of recovery technology and utilization in food coloring and feed
`
`coloring of the red carotenoid pigment astaxanthin as a trace valuable substance in
`
`krill lipids as a means of promoting the effective utilization of krill.” Ex. 1005 at p.
`
`275. “b. Extraction tests using a dip/agitation-type intermediate extractor… The
`
`samples for use in the utilization testing in food and feed pigments were prepared
`
`mainly using hexane extraction with adjustment of the meal water content to
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`approximately 20%. The manufacturing process is described below. 200 L of
`
`hexane, water corresponding to a meal water content of 20%, and 40 kg of krill
`
`meal were added to the extraction can, and extraction was performed with reflux
`
`and heating for 1 hour (59°C) while stirring the material. Next, the material was
`
`filtered under reduced pressure using a filter, and the filtration residue was washed
`
`three times using 40 L of hexane. The filtrate and wash solution were combined in
`
`a concentration can, and the majority of the hexane was distilled off and recovered
`
`at 200 Torr and 30°C. Solvent removal was performed in a secondary
`
`concentration can at 40 Torr and 70°C in order to obtain the crude pigment oil.” Id.
`
`at pp. 284-285. Id. at p. 284. “c. Hexane extraction tests using the once-through
`
`method. It was believed that it was appropriate to use a battery extractor, which is
`
`commonly used in mid-scale production of vegetable oil, as the practical extractor
`
`for krill meal. Therefore, first, model extraction tests were performed using a
`
`smallscale glass column, and then extraction tests were performed using an oil
`
`plant once-through pilot apparatus in order to determine the appropriateness of
`
`once-through extraction. High-water content krill meal (water content: 14.4%) that
`
`was manufactured experimentally on a ship with a somewhat high water content
`
`was used as the krill meal. Model tests: After adjusting the water content of the
`
`meal to 20%, the material was used to fill a glass column (0 4 cm) to a height of 24
`
`cm. The material was heated to 50°C and hexane was passed through the column
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`for 4 hours at a flow rate of 250 ml/h. Table 5 shows the results of these tests.” Id.
`
`at p. 285.
`
`
`
`307. The Fujita Reference inherently discloses the phospholipids recited in
`
`claim 1 of the ‘351 Patent. The claimed phospholipid would necessarily be present
`
`in the lipid extraction of krill performed in the Fujita Reference, as established by
`
`Dr. van Breemen’s testing of the krill extracted according to the Fujita-hexane,
`
`Fujita-hexane/ethanol, and Fujita once-through methods, and demonstrated that
`
`each of the following three Claimed Phospholipid species were detected in the
`
`extract: PC-DHA/DHA, PCEPA/EPA, and PC-EPA/DHA.
`
` Van Breemen
`
`Declaration (Ex. 1040) at ¶¶ 43-49 and 66-71.
`
`
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`163
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`164
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`308. The Fujita Reference discloses a krill extract that is suitable for
`
`human consumption, as recited in claim 1 of the ‘351 patent. See, e.g.: “[I]f the
`
`pigment recovery residue could be utilized as food product or feed, it would be
`
`possible to reach the goal of overall effective utilization of krill, and this could
`
`contribute to the move towards using krill as a food product, which is a
`
`fundamental topic in this project.” Ex. 1005 at p. 275. “Solvent extraction
`
`conditions: Hexane, ethanol and acetone were primarily used in the investigation
`
`as these are organic solvents that can be legally used in food products…” Id. at. p.
`
`276. “b. The suitability for utilization in various types of food products was
`
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`investigated by adding pigment oils with different degrees of purification in order
`
`to color various food products, such as processed fish cake as an example of a
`
`fishery protein food product, rice crackers as an example of a carbohydrate
`
`confectionary, and butter cream as an example of an oil and fat food product, and
`
`then looking at the relationship between taste, color and the degree of
`
`purification.” Id. at p. 279.
`
`309. The Fujita Reference discloses a krill extract that has a total
`
`phospholipid concentration in an amount of about 40% w/w, wherein about
`
`represents ±10%, as recited in claim 2 of the ‘351 patent. See, Ex. 1005 at pp. 284-
`
`286, Tables 4-6.
`
`310. The Fujita Reference discloses a krill extract that has a total
`
`phospholipid concentration in an amount of about 45% w/w, wherein about
`
`represents ±20%, as recited in claim 3 of the ‘351 patent. See, Ex. 1005 at pp. 284-
`
`286, Tables 4-6.
`
`311. The Fujita Reference inherently discloses the a krill extract that
`
`further comprises an additional lipid, including monoglycerides, triglycerides, and
`
`free fatty acids, as recited in claim 4 of the ‘351 patent. Ex. 1005 at pp. 284-286,
`
`Tables 4-6. The claimed additional lipids would necessarily be present because the
`
`extracts in the Fujita Reference contained neutral lipids. Id. The Fujita-hexane
`
`and Fujita-hexane/ethanol krill extracts that Dr. van Breemen prepared were tested
`166
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`at Avanti for free fatty acid content, and the results of the testing shows that the
`
`Fujita reference inherently discloses “free fatty acids of about 5% w/w of the lipids
`
`in the extract.” See, e.g., Van Breemen Declaration (Ex. 1040) at ¶¶ 43-47; Moore
`
`Declaration (Ex. 1044) at p. 6.
`
`
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`167
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`312. The Fujita Reference discloses a krill extract that inherently has a
`
`
`
`concentration of free fatty acids of about 5% w/w of the lipids in the extract, as
`
`recited in claim 5 of the ‘351 patent. See, e.g., Van Breemen Declaration (Ex.
`
`1040) at ¶¶ 43-47; Moore Declaration (Ex. 1044) at p. 6.
`
`
`
`313. The Fujita Reference discloses a krill extract that inherently further
`
`comprises polyunsaturated fatty acids which comprise at least 15% w/w of the
`
`lipids in the extract, as recited in claim 6 of the ‘351 patent. The Fujita-hexane and
`
`Fujita-hexane/ethanol krill extracts that Dr. van Breemen prepared were tested for
`
`polyunsaturated fatty acid content. The results of the testing show that the Fujita
`
`reference inherently discloses krill extracts that “further comprise polyunsaturated
`
`fatty acids which comprise at least 15% w/w of the lipids in the extract.” See, e.g.,
`
`Van Breemen Declaration (Ex. 1040) at ¶¶ 43-47 and Moore (Ex. 1044) at Table 2
`
`of Exhibit A.
`
`
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`314. The Fujita Reference discloses a krill extract that inherently contains
`
`omega-3 fatty acids in an amount of at least 15% w/w of the lipids in the extract, as
`
`recited in claim 9 of the ‘351 patent. Ex. 1005 at page 299, Table 17. See, Lee
`
`(Ex. 1045) at Exhibit A and Moore (Ex. 1044) at Table 2 of Exhibit A.
`
`
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`169
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`Inter Partes Review of US 8,278,351
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`315. The Fujita-hexane and Fujita-hexane/ethanol krill extracts that Dr. van
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`Breemen prepared were tested for polyunsaturated fatty acid content. The results of
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`this testing shows that the Fujita reference inherently discloses a krill extracts that
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`further comprise polyunsaturated fatty acids which comprise at least 15% w/w of
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`the lipids in the extract See, e.g., Van Breemen Declaration (Ex. 1040) at ¶¶ 43-47
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`and 66-69.
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`316. The Fujita Reference discloses a krill extract that inherently contains a
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`metal, as recited in claim 12 of the ‘351 patent. Lee declaration (Ex. 1045) at p.
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`Appendix A, 2.
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`317. The Fujita Reference discloses a krill extract that inherently contains
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`zinc, selenium or a mixture thereof metal, as recited in claim 13 of the ‘351 patent.
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`See, e.g., Lee declaration (Ex. 1045) at p. Appendix A, 2.
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`318. The Fujita Reference discloses a krill extract that inherently contains
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`zinc that comprises at least 0.005 mg/100 g of the extract and selenium that
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`comprises less than 3 mg/100 g of the extract, as recited in claim 14 of the ‘351
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`patent. This was confirmed by repeat testing demonstrates that extracts such as
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`those disclosed in the Fujita Reference contain zinc. See, e.g., Lee declaration (Ex.
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`1045) at p. Appendix A, 2.
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`319. The Fujita Reference inherently discloses the claimed phospholipid,
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`wherein one of R1 and R2 is EPA and the other is DHA, as recited in claim 19 of
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`the ‘351 patent. The claimed phospholipid, wherein one of R1 and R2 is EPA and
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`the other is DHA, would necessarily be present in the total lipid extraction of krill
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`performed in the Fujita Reference as evidenced by Dr. van Breemen’s testing of
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`the krill extracted according to the Fujita-hexane, Fujita-hexane/ethanol, and Fujita
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`once-through methods, which demonstrated that each of the phospholipid species
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`was present in the extracts. Van Breeman declaration (Ex. 1040) at ¶¶ 65-70.
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`320. The Fujita Reference inherently discloses the claimed phospholipid,
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`wherein R1 and R2 is EPA, as recited in claim 20 of the ‘351 patent. The claimed
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`phospholipid, wherein R1 and R2 is EPA, would necessarily be present in the total
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`lipid extraction of krill performed in the Fujita Reference as evidenced by Dr. van
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`Breemen’s testing of the krill extracted according to the Fujita-hexane, Fujita-
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`hexane/ethanol, and Fujita once-through methods, which demonstrated the
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`phospholipid species was present in the extracts. Van Breeman declaration (Ex.
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`1040) at ¶¶ 65-70.
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`172
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`321. The Fujita Reference inherently discloses the claimed phospholipid,
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`wherein R1 and R2 is DHA, as recited in claim 21 of the ‘351 patent. The claimed
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`phospholipid, wherein R1 and R2 is DHA, would necessarily be present in the total
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`lipid extraction of krill performed in the Fujita Reference as evidenced by Dr. van
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`Breemen’s testing of the krill extracted according to the Fujita-hexane, Fujita-
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`hexane/ethanol, and Fujita once-through methods, which demonstrated the
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`phospholipid species was present in the extracts. Van Breeman declaration (Ex.
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`1040) at ¶¶ 65-70.
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`173
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`322. The Fujita Reference discloses a krill extract that further comprises an
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`antioxidant (astaxanthin), as recited in claim 22 of the ‘351 patent. See, e.g., Ex.
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`1005 at pp. 284-285, Tables 4-5.
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`174
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`323. Fujita-hexane and Fujita-hexane/ethanol krill extracts that Dr. van
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`Breemen prepared were tested at Chemir for astaxanthin, an antioxidant. The
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`results of this testing shows that the Fujita reference discloses krill extracts that
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`includes antioxidants. See, Moore (Ex. 1044) at Exhibit A.
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`
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`324. The Fujita Reference discloses a krill extract that further comprises an
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`antioxidant selected from the group consisting of vitamin A, vitamin E,
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`carotenoid, beta-carotene, astaxanthin, canthaxanthin, flavonoids, and mixtures
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`thereof as recited in claim 23 of the ‘351 patent. See, e.g., Ex. 1005 at pp. 284-
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`285, Tables 4-5 and Moore (Ex. 1044) at Exhibit A.
`175
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`325. The Fujita Reference inherently discloses at least a solution and/or a
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`syrup comprising a krill extract, as recited in claim 24 of the ‘351 patent. See,
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`176
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`discussion of claim 1, at ¶¶306-308, supra. One of ordinary skill in art would
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`understand that a krill oil extract is a solution.
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`326. Claims 25-29, 32, 35-37, and 42-46 of the ‘351 patent are identical to
`
`claims 2-6, 9, 12-14, and 19-23 of the ‘351 patent. See ¶¶309-324, supra.
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`327. The Fujita Reference article discloses foods comprising a krill extract,
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`as recited in claim 47 of the ‘351 patent. See Ex. 1005 at p. 291-98. See also
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`¶¶306-308, supra
`
`328. Claims 48-52, 55, 58-60, and 65-69 of the ‘351 patent are identical to
`
`claims 2-6, 9, 12-14, and 19-23 of the ‘351 patent. See ¶¶309-324, supra.
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`329. The Fujita Reference discloses a cosmetic preparation comprising a
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`krill extract, as recited in claim 70 of the ‘351 patent. The person of ordinary skill
`
`in the art would understand that a krill oil safe for human consumption could be
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`used as a “cosmetic preparation.” The claimed phospholipid would necessarily be
`
`present in the total lipid extraction of krill performed in the Fujita Reference. The
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`extract is suitable for human consumption. See, discussion of claim 1, ¶¶306-308,
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`supra.
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`330. The Fujita Reference discloses the embodiment wherein the topical
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`cosmetic product is one or more of a moisturizing cream and a sun-block product,
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`as recited in claim 71 of the ‘351 patent. The person of ordinary skill in the art
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`177
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`would understand that a krill oil safe for human consumption could be used as a
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`“moisturizing cream.”
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`331. Claims 73-77, 80, 83-85, and 90-94 of the ‘351 patent are identical to
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`claims 2-6, 9, 12-14, and 19-23 of the ‘351 patent. See ¶¶309-324, supra.
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`4.1.1.5.2 The Fujita Reference (testing)
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`332. I have reviewed the Van Breemen Declaration (Ex. 1040). As
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`described in his report, Dr. van Breemen extracted E. superba according to what I
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`will refer to as the “Fujita-hexane”; the “Fujita-hexane/ethanol”; and the “Fujita-
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`once through” extraction methods. I have reviewed the Fujita Reference and Dr.
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`van Breemen’s report, and in my opinion Dr. van Breemen properly performed the
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`extractions in accordance with the Fujita Reference. I understand that Dr. van
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`Breemen scaled down the “Fujita-hexane”; the “Fujita-hexane/ethanol” extractions
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`to lab scale. It is my opinion that scaling down the extractions provided consistent
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`results with what you would expect on a larger scale because the extraction is
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`fundamentally the same and is workable on multiple different scales.
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`333. Dr. Richard van Breemen analyzed the samples he prepared for the
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`presence of phosphatidylcholine (“PC”) containing two EPA molecules; PC
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`containing two DHA molecules; and PC containing an EPA molecule and a DHA
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`molecule. Having spoken to Dr. van Breemen, I believe that Dr. van Breemen
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`conducted these tests properly and that he did, in fact, confirm the presence of each
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`of these phospholipids in each of the samples tested.
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`334. Chemir analyzed the samples from the Fujita-hexane and Fujita-
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`hexane/ethanol methods for the presence of fatty acids, metals, and astaxanthin. I
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`spoke with Chemir prior to the testing to confirm that they would be conducting
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`the appropriate analyses. I also reviewed the Expert Witness Report of Albert C.
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`Lee, Ph.D. (Ex. 1045) and confirmed that they conducted the analyses in
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`accordance with the methods described in Dr. Lee’s report.
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`335. Avanti Polar Lipids (“Avanti”) analyzed samples from the Fujita-
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`hexane and Fujita-hexane/ethanol methods for total lipids and phospholipids. I
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`spoke with Avanti prior to the testing to confirm that they would be conducting the
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`appropriate analyses. I also reviewed the Expert Witness Report of Jeff D. Moore,
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`Ph.D. (Ex. 1044) and confirmed that they conducted the analyses in accordance
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`with the methods described in Dr. Moore’s report.
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`4.1.1.6.
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`Rogozhin (Ex. 1008)
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`336. In my opinion, Rogozhin discloses each and every limitation of
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`Claims 1, 19-21, 24, and 42-44, 47, and 65-67 of the ’351 Patent, and, therefore
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`anticipates these claims.
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`179
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`337. I understand that Rogozhin was published at least by April 7, 1981,
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`and is therefore 35 U.S.C. § 102(b) prior art to each of the ‘351 Patent even under
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`Patentee’ proposed priority date. I also understand that the Patent Office
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`considered Rogozhin during the prosecution of the application that granted as the
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`’351 Patent.
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`338. As I discussed above, I have also been informed that to anticipate, a
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`prior art reference must contain an enabling disclosure that allows one of ordinary
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`skill to practice the claims without undue experimentation. In my opinion,
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`Rogozhin describes to one of ordinary skill in the art how to practice or carry out
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`the claims in sufficient detail, without requiring undue experimentation.
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`339. Rogozhin discloses a krill extract, as recited in claim 1 of the ‘351
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`patent, that is prepared by a process for extracting lipids from krill that does not
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`employ heat. See, e.g.: “Example 1 In an apparatus with a capacity of 10 l provided
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`with a stirrer there is placed 1 kg of krill which is filled with water and stirred to
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`1,000 rpm for 0.3 hour. The resultant emulsion of lipids is separated from the krill
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`mass by filtration through a stainless steel screen having a mesh size of 1x1 mm.”
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`Ex. 1008 at p. 10. Rogozhin discloses a krill extract prepared by a process for
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`extracting lipids from krill that does not employ heat. See, Van Breeman
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`Declaration (Ex. 1040) at ¶¶71-72.
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`340. Rogizhin describes an extract
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