Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`none of the Claims are entitled to claim priority to the Provisional Application or a
`
`priority date of July 27, 2001.
`
`3.2 Effect of Priority Date on Invalidity
`
`170. I understand that the priority date to which the Claims of the ’351
`
`patent is entitled affects (i) whether certain references are prior art and (ii) the
`
`subsections of § 102 under which references qualify as prior art. The table below
`
`shows, on a reference-by-reference basis, the effect of the priority date on the prior
`
`art status of various references.
`
`Reference
`
`If Priority
`
`If Priority Date
`
`Date is July 27,
`
`is July 29, 2002
`
`2001
`
`Ex. 1011. Neptune’s “Final
`
`§ 102(a)
`
`Prospectus” (the “Neptune
`
`Prospectus,”), which published on
`
`May 11, 2001.
`
`Ex. 1012. Neptune press release titled
`
`§ 102(a)
`
`“Neptune Technologies &
`
`Bioressources Soon to Obtain a Major
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`
`
`101
`
`00000101
`
`
`Ex. 1042, Brenna Declaration
`
`
`
`none of the Claims are entitled to claim priority to the Provisional Application or a
`
`priority date of July 27, 2001.
`
`3.2 Effect of Priority Date on Invalidity
`
`170. I understand that the priority date to which the Claims of the ’351
`
`patent is entitled affects (i) whether certain references are prior art and (ii) the
`
`subsections of § 102 under which references qualify as prior art. The table below
`
`shows, on a reference-by-reference basis, the effect of the priority date on the prior
`
`art status of various references.
`
`Reference
`
`If Priority
`
`If Priority Date
`
`Date is July 27,
`
`is July 29, 2002
`
`2001
`
`Ex. 1011. Neptune’s “Final
`
`§ 102(a)
`
`Prospectus” (the “Neptune
`
`Prospectus,”), which published on
`
`May 11, 2001.
`
`Ex. 1012. Neptune press release titled
`
`§ 102(a)
`
`“Neptune Technologies &
`
`Bioressources Soon to Obtain a Major
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`
`
`101
`
`00000101
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`
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`Patent in Over 30 Countries”
`
`(“Neptune Press Release,”), which
`
`published on June 14, 2001.
`
`Ex. 1002. WO 00/23546 (“Beaudoin
`
`I”), which published on April 27,
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`2000.
`
`Ex. 1003. CA 2,251,265 (“Beaudoin
`
`II,”), published on April 21, 2000.
`
`Ex. 1004. Japanese Unexamined
`
`Patent Application Publication No.
`
`02-215351, titled Krill Phospholipids
`
`Fractioning Method (“Maruyama,”),
`
`was filed by Kazuki Maruyama et al.
`
`It published on August 28, 1990.
`
`Ex. 1010. WO 97/39759 to Stoll et al.
`
`(“Stoll,”) titled “Omega-3 fatty acids
`
`and omega-3 phosphatidylcholine in
`
`
`
`102
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`00000102
`
`
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`Inter Partes Review of US 8,278,351
`Ex. 1042, Brenna Declaration
`
`
`
`the treatment of bipolar disorder,”
`
`published on October 30, 1997.
`
`Ex. 1006. Fricke et al., Lipid, Sterol,
`
`and Fatty Acid Composition of
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`Antarctic Krill, Lipids, Vol. 19, No.
`
`11, pp. 821-827 (1984) (“the Fricke
`
`Article”) The Fricke Article published
`
`in November 1984.
`
`Ex. 1009. Itano Refrigerated Food
`
`Co., Ltd., Bio & High Technology
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`Announcement
`
`and
`
`Natural
`
`Astaxanthin & Krill Lecithin (on or
`
`before December 28, 1994) (“the
`
`Itano Brochure,”).
`
` The
`
`Itano
`
`Brochure was published by at least
`
`December 28, 1994, when it was cited
`
`to
`
`the U.S.P.T.O
`
`during
`
`the
`
`prosecution of U.S.
`
` Pat.
`
` No.
`
`
`
`103
`
`00000103
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`Inter Partes Review of US 8,278,351
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`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`
`
`5,527,533.
`
`Ex. 1014. Japanese Patent No. 60-
`
`153779,
`
`titled
`
`Supplementary
`
`nutritive food comprises vitamin=E
`
`and soybean lecithin dissolved in oil
`
`with high eicosapentaenoic acid
`
`content (“Fukuoka ,”), was filed by
`
`Osamu Fukuoka et al.
`
` It was
`
`published on August 13, 1985.
`
`Ex. 1015. Japanese Patent Publication
`
`No. H08-231391, titled Dementia-
`
`Improving Medicine (“Yazawa”), was
`
`filed by Kazuyoshi Yazawa et al. It
`
`was published on September 10,
`
`1996.
`
`Ex. 1005. The Fisheries Agency,
`
`General Report on Research and
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`Development of Techniques
`
`in
`
`
`
`104
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`00000104
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`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`
`
`Processing and Utilization of Marine
`
`Products (March 1985) (the “General
`
`Report”).
`
` I understand
`
`that
`
`the
`
`General Report, including the Fujita
`
`Reference, was published in March
`
`1985, and is therefore prior art to each
`
`of the ‘351 Patent under at least 35
`
`U.S.C. § 102(b), even under Patentee’
`
`earliest alleged priority date. See
`
`Expert Witness Report of Theodore F.
`
`Welch, Ph.D Regarding Public
`
`Accessibility of Certain References at
`
`¶¶ 25-44; see also Van Breemen
`
`Declaration at ¶¶ 36-40.
`
`Ex. 1008. Canadian Patent No.
`
`1098900,
`
`titled Method
`
`for
`
`the
`
`Processing of Krill
`
`to Produce
`
`Protein,
`
`Lipids
`
`and
`
`Chitin
`
`
`
`105
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`00000105
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`
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`(“Rogozhin,”), was filed by Sergei
`
`Rogozhin et al. It was published on
`
`published April 7, 1981. Ex. 1008.
`
`Ex. 1016. Suzuki, T. and Shibata, N.,
`
`“The utilization of Antarctic krill for
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`human food,” Food Rev. Int’l, 6:1,
`
`119-147
`
`(1990)
`
`(“the
`
`Suzuki
`
`Article,”), The Suzuki Article was
`
`published in 1990. Ex. 1016.
`
`Ex. 1017. Bergelson (ed.), Lipid
`
`Biochemical Preparations, Chapter
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`I.1, pp. 1-13 (1980) (“Bergelson
`
`Reference”), was published in 1980.
`
`Ex. 1018. WHO News and Activities,
`
`Bulletin of
`
`the World Health
`
`Organization, 73(4), pp.
`
` 547-51
`
`(1995)
`
`(“WHO Bulletin”) was
`
`
`
`106
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`00000106
`
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`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(b)
`
`
`
`published in 1995.
`
`Ex. 1019. Bell and Dick, Molecular
`
`Species Composition of the Major
`
`Diacyl Glycerophospholipids
`
`from
`
`Muscle, Liver, Retina and Brain of
`
`Cod (Gadus morhua), Lipids, Vol.
`
`26, No. 8, pp. 565-573 (1991)
`
`(“Bell and Dick Article”) was
`
`published in 1991.
`
`Ex. 1020. Henderson et al., Lipid
`
`Composition of the Pineal Organ
`
`from Rainbow Trout (Oncorhynchus
`
`mykiss), Lipids, Vol. 29, No. 5, pp.
`
`311-317
`
`(1994)
`
`(“Henderson
`
`Article”) was published in 1994.
`
`Ex. 1013. Le Grandois et al.,
`
`
`
`
`
`Investigation
`
`of
`
`Natural
`
`Phosphatidylcholine
`
`Sources:
`
`
`
`107
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`
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`Separation and
`
`Identification by
`
`Liquid Chromatography -Electrospray
`
`Ionization-Tandem
`
`Mass
`
`Spectrometry
`
`(LC-ESI-MS2)
`
`of
`
`Molecular Species, J. Agric. Food
`
`Chem., 57, 6014-20 (2009) (“the Le
`
`Grandois Article,”). The Le Grandois
`
`Article was published in 2009.
`
`
`
`4.
`
`PATENTABILITY OPINIONS
`
`4.1 Each element of the Claims of the ‘351 Patent is taught by one or
`
`more prior art references and/or Rendered Obvious by a combination of
`
`references or a single reference
`
`171. It is my opinion that every element of each claim of the ‘351 patent is
`
`taught and/or rendered obvious by one or more prior art reference.
`
`172. The prior art references and products discussed in this report disclose
`
`the elements of the Claims either explicitly, or inherently, or disclose an obvious
`
`modification in light of the state of the art in the relevant timeframe. If a reference
`
`
`
`108
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`is used in a combination, this does not mean that the reference itself does not
`
`anticipate the claim.
`
`173. The specific combinations I discuss in this report are exemplary, and
`
`are not intended to indicate that any other references I rely upon do not also
`
`disclose the limitation in question. Further, any citations to text or figures are also
`
`exemplary. Other portions of the prior art may also contain information and/or
`
`teachings that disclose or suggest elements of the Claims.
`
`174. As discussed above, it is my opinion that every element of each of the
`
`Claims of the ‘351 Patent it taught by certain prior art. In the following sections, I
`
`provide a narrative of my opinions.
`
`4.1.1.1.
`
`Beaudoin (Ex. 1002)
`
`175. In my opinion, Beaudoin I (reference and testing) discloses each and
`
`every limitation of the Claims, and, therefore anticipates these claims.
`
`176. I understand that Beaudoin I was published on April 27, 2000, and is
`
`therefore 35 U.S.C. § 102(b) prior art to each claim of the ‘351 Patent. I also
`
`understand that the Patent Office considered Beaudoin I during the prosecution of
`
`the application that granted as the ’351 Patent.
`
`177. Beaudoin I discloses extracts prepared by a process for extracting
`
`lipids from krill that does not employ heat. See Beaudoin I at 4-6 and Table 19, as
`
`
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`109
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`recited in claim 1 of the ‘351 patent. This is confirmed by Neptune Technologies &
`
`Bioressources Inc., Final Prospectus dated May 11, 2001 (“Neptune Prospectus”)
`
`at 13-15; Neptune Technologies & Bioressources Inc. Press Release dated June 14,
`
`2001 (“Neptune Press Release”). Furthermore, even if the Beaudoin I process
`
`employs a heating step, this would not substantively affect the phospholipids of the
`
`extract. The process disclosed in Beaudoin I is virtually identical to the process
`
`disclosed in the ‘351 patent, especially for the acetone extraction of Fraction I. It
`
`follows that the products from these processes would be virtually identical.
`
`178. Beaudoin I discloses a phospholipid of the general formula (I), having
`
`R1, R2 and X as recited in claim 1 of the ‘351 patent. This phospholipid is
`
`inherently present in the Beaudoin I krill extract. See Beaudoin I at 4-6 and Table
`
`19. This inherency has been confirmed in at least several reexamination
`
`declarations. See the Shahidi (Ex. 1056 and Ex. 1059), Yeboah (Ex. 1054 and Ex.
`
`1058), Gundersen (Ex. 149 and 1050), Van Breeman (Ex. 1066 and 1067), and
`
`Haugsgjerd (Ex. 1047 and 1048) reexamination declarations. This inherency was
`
`also confirmed in the December 22, 2009, Final Report, Identification and
`
`Quantification of Phospholipids in Beaudoin Oil No. Lab: 09-1651, by Earl L.
`
`White (Ex. 1051). Furthermore, these phospholipids are known to be present in
`
`krill, and Patentee has acknowledged that the Beaudoin I process extracts and
`
`preserves the biological activity of intrinsic krill substances such as phospholipids,
`110
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`causing minimal lipidic alterations. See, e.g., Neptune prospectus, Ex. 1011 at 13-
`
`15; Neptune press release, Ex. 1012; see also Winther et al., Elucidation of
`
`Phosphatidylcholine Composition in Krill Oil Extracted from Euphausia Superba,
`
`Lipids, 46, 25-36 (2011)(“Winther,” Ex. 1031 at Table 2; Le Grandois, Ex. 1013 at
`
`Table 2). This inherency has been confirmed by Dr. Van Breemen’s testing of the
`
`E. Pacifica and E. Superba extracts prepared by Dr. Budge. (Van Breemen
`
`Declaration, Ex. 1040 at ¶¶ 74-85) See data from Ex. 1040 below.
`
`
`
`
`
`
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`113
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`
`
`179. Beaudoin I discloses that its krill extracts are useful as dietary
`
`supplements, as recited in claim 1 of the ‘351 patent. See Beaudoin I at 1. Inventor
`
`Beaudoin consumed the extracts, with no adverse effects: “One of the inventors,
`
`Dr. Adrien Beaudoin, has ingested the different lipid fractions of krill. No side
`
`effect profile was observed.” See Ex. 1002 at 12. In the event that the claim is
`
`construed to require less residual solvent than that contained in the Beaudoin I
`
`
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`extracts, Beaudoin I also discloses that fractions I and II may be further processed
`
`by heating to 125°C for 15 minutes. Beaudoin I at 7.
`
`180. Beaudoin I discloses a krill extract that inherently has a total
`
`phospholipid concentration in an amount of about 40%, as recited in claim 2 of the
`
`‘351 patent. See Ex. 1002 at 4-6, Tables 14 and 19. Further, during the
`
`reexamination of the ’348 patent, Neptune submitted a declaration by Dr. Faustinus
`
`Yeboah (Ex. 1054), in which Dr. Yeboah explained that phospholipids account for
`
`“about 40%” of the total lipids in krill oil when analyzing the composition of a krill
`
`oil purportedly made in accordance with Beaudoin (Yeboah Declaration, Ex. 1054
`
`at ¶ 36). This inherency has been confirmed by Avanti’s testing of the E. Superba
`
`extract prepared by Dr. Budge. (Moore Decl., Ex. 1044, Table 11, reproduced
`
`below)
`
`
`
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`181. Beaudoin I discloses a krill extract that inherently has a total
`
`
`
`phospholipid concentration in an amount of about 45%, as recited in claim 3 of the
`
`‘351 patent. See Beaudoin I at 4-6, Tables 14 and 19. Further, during the
`
`reexamination of the ’348 patent, Neptune submitted a declaration by Dr. Faustinus
`
`Yeboah (Ex. 1054), in which Dr. Yeboah explained that phospholipids account for
`
`“about 40%” of the total lipids in krill oil when analyzing the composition of a krill
`
`oil purportedly made in accordance with Beaudoin I. (Yeboah Declaration, Ex.
`
`1054 at ¶ 36). This inherency has been confirmed by Avanti’s testing of the E.
`
`Pacifica and E. Superba extracts prepared by Dr. Budge. (Moore Decl., Ex. 1044,
`
`Table 11, reproduced above.)
`
`182. Beaudoin I discloses a krill extract that inherently contains additional
`
`lipids, e.g., monoglycerides, triglycerides, cholesterols and free fatty acids, as
`
`recited in claim 4 of the ‘351 patent. See Ex. 1002 at 4-6 and Tables 14 and 19.
`
`183. Beaudoin I discloses a krill extract that inherently contains “about 5%
`
`w/w” free fatty acids, as recited in claim 5 of the ‘351 patent. See Beaudoin I at 4-6
`
`and Tables 14 and 19.
`
`184. Beaudoin I discloses a krill extract
`
`that
`
`inherently contains
`
`polyunsaturated fatty acids in an amount of at least 15% w/w of the lipids in the
`
`extract, as recited in claim 6 of the ‘351 patent. See Ex. 1002 at 4-6 and Tables 14-
`
`16 and 19. This inherency has been confirmed by Chemir’s and Avanti’s testing of
`116
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`the E. Superba and E. Pacifica extracts prepared by Dr. Budge. (Lee Decl., Ex.
`
`1045 Table 7 of Exhibit A, reproduced below; Moore Decl., Ex. 1044 Table 11,
`
`reproduced above.)
`
`
`
`185. Beaudoin I discloses a krill extract
`
`that
`
`inherently contains
`
`polyunsaturated fatty acids in an amount of at least 40% w/w of the lipids in the
`
`extract, as described in claim 7 of the ‘351 patent. See Ex. 1002 at 4-6 and Tables
`
`14-16 and 19.
`
`186. Beaudoin I discloses a krill extract
`
`that
`
`inherently contains
`
`polyunsaturated fatty acids in an amount of at least 45% w/w of the lipids in the
`
`extract, as recited in claim 8 of the ‘351 patent. See Ex. 1002 at 4-6 and Tables 14-
`
`16 and 19.
`
`187. Beaudoin I 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
`
`
`
`117
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`in claim 9 of the ‘351 patent. See Beaudoin I at 4-6 and Tables 14-16 and 19. This
`
`inherency has been confirmed by Chemir’s and Avanti’s testing of the E. Superba
`
`and E. Pacifica extracts prepared by Dr. Budge. (Lee Decl., Ex. 1045 Table 7 of
`
`Exhibit
`
`A;
`
`Moore
`
`Decl.,
`
`Ex.
`
`1044
`
`Table
`
`11.)
`
`
`
`
`
`188. Beaudoin I discloses a krill extract that inherently contains DHA and
`
`EPA in an amount of at least 32% w/w of the lipids in the extract, as recited in
`
`claim 10 of the ‘351 patent. See Ex. 1002 at 4-6 and Tables 14-16 and 19.
`
`
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`118
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`189. Beaudoin I discloses a krill extract that inherently contains DHA and
`
`
`
`EPA in an amount of at least 35% w/w of the lipids in the extract, as recited in
`
`claim 11 of the ‘351 patent. See Ex. 1002 at 4-6 and Tables 14-16 and 19.
`
`190. Beaudoin I discloses a krill extract that inherently contains a metal, as
`
`recited in claim 12 of the ‘351 patent. See Beaudoin I at 4-6 and Table 19. This
`
`inherency has been confirmed by Chemir’s testing of the E. Superba and E.
`
`Pacifica extracts prepared by Dr. Budge. (Lee Decl., Ex. 1045 Table 7 of Exhibit
`
`A.)
`
`
`
`191. Beaudoin I discloses a krill extract that inherently contains zinc and/or
`
`Selenium, as recited in claim 13 of the ‘351 patent. See Ex. 1002 at 4-6 and Table
`
`19. This inherency has been confirmed by Chemir’s testing of the E. Superba and
`
`
`
`119
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`
`
`
`E. Pacifica extracts prepared by Dr. Budge. (Lee Decl., Ex. 1045 Table 7 or
`
`Exhibit A.)
`
`
`
`192. Beaudoin I discloses a krill extract that inherently contains zinc and/or
`
`Selenium wherein the zinc comprises at least 0.005 mg/100 g of the extract and the
`
`selenium comprises less than 3 mg/100 g of the extract, as recited in claim 14 of
`
`the ‘351 patent. See Beaudoin I at 4-6 and Table 19. This inherency has been
`
`confirmed by Chemir’s testing of the E. Superba and E. Pacifica extracts prepared
`
`by Dr. Budge. (Lee Decl., Ex. 1045 Table 7 of Exhibit A.)
`
`193. Beaudoin I discloses a krill extract that inherently contains the fatty
`
`acid composition of the lipids in the extract of about: [see Table in claim 15 of
`
`‘351 patent] wherein about represents ±10%, as recited in claim 15 of the ‘351
`
`patent. The Beaudoin I extract is made by a process essentially identical to the
`
`process disclosed in the ‘351 patent. See ¶64, supra
`
`194. Beaudoin I discloses a krill extract that inherently contains the total
`
`fatty acid composition of all the lipids in the extract is: [see Table in claim 16 of
`
`‘351 patent], as recited in claim 16 of the ‘351 patent. The Beaudoin I is made by a
`
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`120
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`
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`process essentially identical to the process disclosed in the ‘351 patent. See ¶64,
`
`supra
`
`195. Beaudoin I discloses a krill extract that inherently contains the total
`
`fatty acid composition of all the lipids in the extract is: [see Table in claim 17 of
`
`‘351 patent], as recited in claim 17 of the ‘351 patent. The Beaudoin I extract is
`
`made by a process essentially identical to the process disclosed in the ‘351 patent.
`
`See ¶64, supra
`
`196. Beaudoin I discloses a krill extract
`
`that
`
`inherently contains
`
`components recited in: [see Table in claim 18 of ‘351 patent], as recited in claim
`
`18 of the ‘351 patent. The Beaudoin I extract is made by a process essentially
`
`identical to the process disclosed in the ‘351 patent. See ¶64, supra
`
`197. Beaudoin I discloses a krill extract that inherently contains a
`
`phospholipid of the general formula (I), having one of R1 and R2 as an EPA
`
`residue and the other as a DHA residue, as recited in claim 19 of the ‘351 patent.
`
`See Ex. 1002 at 4-6 and Table 19. This inherency has been confirmed by Dr. Van
`
`Breeman’s testing of the Haugsgjerd extracts, as well as the Budge extracts (See
`
`Van Breemen Declaration, Ex. 1040 at ¶¶ 73-85 and 93-98).
`
`
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`121
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`198. Beaudoin I discloses a krill extract that inherently contains a
`
`phospholipid of the general formula (I), having both R1 and R2 as EPA residues,
`
`as described in claim 20 of the ‘351 patent. See Ex. 1002 at 4-6 and Table 19. This
`
`inherency has been confirmed by Dr. Van Breeman’s testing of the Haugsgjerd
`
`extracts, as well as the Budge extracts (See Van Breemen Declaration, Ex. 1040 at
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`¶¶ 73-85 and 93-98).
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`122
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`199. Beaudoin I discloses a krill extract that inherently contains a
`
`phospholipid of the general formula (I), having both R1 and R2 as DHA residues,
`
`as recited in claim 21 of the ‘351 patent. See Ex. 1002 at 4-6 and Table 19. This
`
`inherency has been confirmed by Dr. Van Breeman’s testing of the Haugsgjerd
`
`extracts, as well as the Budge extracts (See Van Breemen Declaration, Ex. 1040 at
`
`¶¶ 73-85 and 93-98).
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`123
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`200. Beaudoin I discloses a krill extract that inherently contains an
`
`
`
`antioxidant, as recited in claim 22 of the ‘351 patent. See Ex. 1002 at 4-6 and
`
`Tables 17-19. This inherency has been confirmed by Chemir’s testing of the E.
`
`Superba and E. Pacifica extracts prepared by Dr. Budge. (Table 7 of Exhibit A to
`
`Expert Witness Report
`
`of Albert C. Lee,
`
`Ph.D., Ex.
`
`1045)
`
`
`
`201. Beaudoin I discloses a krill extract that contains an antioxidant, e.g.,
`
`vitamin A, vitamin E, astaxanthin, canthaxanthin as recited in claim 23 of the ‘351
`
`patent. See Beaudoin I at 4-6 and Tables 17-19. This inherency has been confirmed
`
`by Chemir’s testing of the E. Superba and E. Pacifica extracts prepared by Dr.
`
`Budge. (Table 7 of Exhibit A to Expert Witness Report of Albert C. Lee, Ph.D.,
`
`Ex. 1040)
`
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`124
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`202. Beaudoin I discloses a krill extract that is “a translucent oil” 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. See Ex. 1002 at 7. Beaudoin I also discloses that its
`
`krill extracts can be used as nutraceuticals or dietary supplements, which the
`
`person of ordinary skill in the art would understand to include a “capsule.” See Ex.
`
`1002 at 1. Beaudoin I discloses extracts prepared by a process for extracting lipids
`
`from krill that does not employ heat and a phospholipid of the general formula (I),
`
`having R1, R2 and X as recited in claim 1 of the ‘351 patent. See discussion of
`
`claim 1 of the ‘351, ¶¶177-179, supra.
`
`203. Claims 25-46 of the ‘351 patent are identical to claims 2-23 of the
`
`‘351 patent. See ¶¶180-201, supra.
`
`204. Beaudoin I discloses a food, beverage, energy bar, or nutritional
`
`supplement comprising a krill extract, as recited in claim 47 of the ‘351 patent.
`
`Beaudoin I also discloses that its krill extracts can be used as nutraceuticals or
`
`dietary supplements, which the person of ordinary skill in the art would understand
`
`to include a “food, beverage, energy bar, or a nutritional supplement.” Beaudoin I
`
`discloses extracts prepared by a process for extracting lipids from krill that does
`
`not employ heat and a phospholipid of the general formula (I), having R1, R2 and
`
`X as recited in claim 1 of the ‘351 patent. See discussion of claim 1 of the ‘351
`
`above, ¶¶177-179, supra.
`
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`125
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`205. Claims 48-69 of the ‘351 patent are identical to claims 2-23 of the
`
`
`
`‘351 patent. See ¶¶180-201, supra.
`
`206. Beaudoin I discloses a cosmetic preparation comprising a krill extract,
`
`as recited in claim 70 of the ‘351 patent. Ex. 1002 at p. 1. The person of ordinary
`
`skill in the art would understand that a krill oil safe for human consumption could
`
`be used as a “cosmetic preparation.” Beaudoin I discloses extracts prepared by a
`
`process for extracting lipids from krill that does not employ heat and a
`
`phospholipid of the general formula (I), having R1, R2 and X as recited in claim 1
`
`of the ‘351 patent. See discussion of claim 1 of the ‘351 above. ¶¶177-179, supra.
`
`207. Beaudoin I 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. Ex. 1002 at p. 1. The person of ordinary skill in the
`
`art would understand that a krill oil safe for human consumption could be used as a
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`“moisturizing cream.”
`
`208. Claims 72-93 of the ‘351 patent are identical to claims 2-23 of the
`
`‘351 patent. See ¶¶180-201, supra.
`
`209. Beaudoin I discloses extracts prepared by a process for extracting
`
`lipids from krill that does not employ heat and a phospholipid of the general
`
`formula (I), having R1, R2 and X as recited in claim 94 of the ‘351 patent. See
`
`discussion of claim 1 of the ‘351 above. Beaudoin I discloses that the extracts are
`126
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`00000126
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`made by extracting lipids from “krill,” which includes Antarctic krill. See Ex. 1002
`
`at 1. The Beaudoin I krill extracts are extracted under conditions suitable for
`
`preserving an effective amount of a phospholipid having two independently
`
`selected fatty acid chains within the same phospholipid selected from EPA and
`
`DHA. See Beaudoin I at 4-6 and Table 19. These phospholipids are known to be
`
`present in krill, and Neptune has acknowledged that the Beaudoin I process
`
`extracts and preserves the biological activity of intrinsic krill substances such as
`
`phospholipids, causing minimal lipidic alterations. See, e.g., Neptune Prospectus,
`
`Ex. 1011 at 13-15; Neptune press release, Ex. 1012; see also Winther, Ex. 1031 at
`
`Table 2; Le Grandois, Ex. 1013 at Table 2. Furthermore, even if the Beaudoin I
`
`process employs a heating step, this would not substantively affect the
`
`phospholipids of the extract. Beaudoin I discloses a krill extract that inherently has
`
`a total phospholipid concentration in an amount of at least 40%. See Ex. 1002 at 4-
`
`6, Tables 14 and 19. Further, during the reexamination of the ’348 patent, Neptune
`
`submitted a declaration by Dr. Faustinus Yeboah, in which Dr. Yeboah explained
`
`that phospholipids account for “about 40%” of the total lipids in krill oil when
`
`analyzing the composition of a krill oil purportedly made in accordance with
`
`Beaudoin I. (Yeboah declaration, March 16, 2012, Ex. 1054 at ¶ 36) This
`
`inherency has been confirmed by Avanti’s testing of the E. Superba extract
`
`
`
`127
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`by Dr. Budge.
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`(Moore Decl., Ex
`
`1044 Table
`
`11.)
`
`
`
`prepared
`
`
`
`210. Beaudoin I 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. See Ex.
`
`1002 at 4-6 and Tables 14-16. This inherency has been confirmed by Chemir’s
`
`testing of the E. Superba extract prepared by Dr. Budge. (Lee Decl., Ex. 1045
`
`Table 7 of Exhibit A.)
`
`
`
`211. Beaudoin I discloses a krill extract that contains astaxanthin. See Ex.
`
`1002 at 4-6 and Tables 18-19. Astaxanthin content has been confirmed by
`
`Chemir’s testing of the E. Superba extract prepared by Dr. Budge. (Table 7 of
`
`
`
`128
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`00000128
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`
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`Exhibit A to Expert Witness Report of Albert C. Lee, Ph.D.; Ex. 1045)
`
`4.1.1.2.
`
`Beaudoin II (Ex. 1003)
`
`
`
`212. In my opinion, Beaudoin II (reference and testing) discloses each and
`
`every limitation of the Claims, and, therefore anticipates these claims.
`
`213. I understand that Beaudoin II was published on April 21, 2000, and is
`
`therefore 35 U.S.C. § 102(b) prior art to each of the ‘351 Patent even under
`
`Patentee’ proposed priority date. I also understand that the Patent Office
`
`considered Beaudoin II during the prosecution of the application that granted as the
`
`’351 Patent.
`
`214. Beaudoin II discloses extracts prepared by a process for extracting
`
`lipids from krill that does not employ heat, as recited in claim 1 of the ‘351 patent.
`
`See Ex. 1003 at 1-2 and Table 11; Neptune prospectus, Ex. 1011 at 13-15; Neptune
`
`press release, Ex. 1012. Furthermore, even if the Beaudoin II process employs a
`
`heating step, this would not substantively affect the phospholipids of the extract.
`
`
`
`129
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`00000129
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`215. A phospholipid of the general formula (I), having R1, R2 and X as
`
`
`
`recited in claim 1 of the ‘351 patent, is inherently present in the Beaudoin II krill
`
`extract. See Ex. 1003 at 1-2 and Table 11. This inherency has been confirmed in at
`
`least several declarations. See the Shahidi (Ex. 1056 and Ex. 1059), Yeboah (Ex.
`
`1054 and Ex. 1058), Gundersen (Ex. 149 and 1050), Van Breeman (Ex. 1066 and
`
`1067), and Haugsgjerd (Ex. 1047 and 1048) reexamination declarations.
`
`216. This inherency was also confirmed in the December 22, 2009, Final
`
`Report, Identification and Quantification of Phospholipids in Beaudoin Oil No.
`
`Lab: 09-1651, by Earl L.White (Ex. 1051). Furthermore, these phospholipids are
`
`known to be present in krill, and Neptune has acknowledged that the Beaudoin I
`
`process, the application for which claims priority to Beaudoin II, extracts and
`
`preserves the biological activity of intrinsic krill substances such as phospholipids,
`
`causing minimal lipidic alterations. See, e.g., Neptune prospectus, Ex. 1011 at 13-
`
`15 (Ex. 1011); Neptune press release (Ex. 1012); Winther, Ex. 1031 at Table 2; Le
`
`Grandois, Ex. 1013 at Table 2). This inherency has also been confirmed by Dr.
`
`Van Breemen’s testing of the E. Pacifica and E. Superba extracts prepared by Dr.
`
`Budge. (Van Breemen Declaration, Ex. 1040 at ¶¶ 73-85). Beaudoin II discloses
`
`that its krill extracts are useful as dietary supplements. See Beaudoin II at 4.
`
`Inventor Beaudoin consumed the extracts, with no adverse effects: “One of the
`
`inventors, Mr. Adrien Beaudoin, has tasted the different lipid fractions. No side
`130
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`00000130
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`
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`effect was observed.” See Beaudoin II at 8. In the event that the claim is construed
`
`to require less residual solvent than that contained in the Beaudoin II extracts,
`
`Beaudoin II also discloses that fractions I and II may be further processed by
`
`heating to 60°C or 70°C for 5 minutes. Ex. 1003 at 3.
`
`217. Beaudoin II discloses a krill extract that inherently has a total
`
`phospholipid concentration in an amount of about 40%, as recited in claim 2 of the
`
`‘351 patent. See Beaudoin II, Ex. 1003 at 1-2, and Table 11; see also Beaudoin I,
`
`Ex. 1002 at Table 14. Further, during the reexamination of the ’348 patent,
`
`Neptune submitted a declaration by Dr. Faustinus Yeboah (Ex. 1054), in which Dr.
`
`Yeboah explained that phospholipids account for “about 40%” of the total lipids in
`
`krill oil when analyzing the composition of a krill oil purportedly made in
`
`accordance with Beaudoin I. (Yeboah Decl., Ex. 1054 at ¶ 36)
`
`218. Beaudoin II discloses a krill extract that inherently has a total
`
`phospholipid concentration in an amount of about 45%, as recited in claim 3 of the
`
`‘351 patent. See Beaudoin II, Ex. 1003 at 1-2, and Table 11; see Beaudoin I, Ex.
`
`1002 at Table 14. Further, during the reexamination of the ’348 patent, Neptune
`
`submitted a declaration by Dr. Faustinus Yeboah, in which Dr. Yeboah explained
`
`that phospholipids account for “about 40%” of the total lipids in krill oil when
`
`analyzing the composition of a krill oil purportedly made in accordance with
`
`Beaudoin I. (Yeboah Decl., Ex. 1054 at ¶ 36)
`131
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`219. Beaudoin II discloses a krill extract that inherently contains additional
`
`
`
`lipids, e.g., monoglycerides, triglycerides, cholesterols and free fatty acids, as
`
`recited in claim 4 of the ‘351 patent. See Beaudoin II, Ex. 1003 at 1-2 and Table
`
`11; see Beaudoin I, Ex. 1002 at Table 14.
`
`220. Beaudoin II discloses a krill extract that inherently contains “about
`
`5% w/w” free fatty acids, as recited in claim 5 of the ‘351 patent. See Beaudoin II,
`
`Ex. 1003 at 1-2 and Table 11; see Beaudoin I, Ex. 1002 at Table 14.
`
`221. Beaudoin II discloses a krill extract that inherently contains
`
`polyunsaturated fatty acids in an amount of at least 15% w/w of the lipids in the
`
`extract, as recited in claim 6 of the ‘351 patent. See Beaudoin II, Ex. 1003 at 1-2
`
`and Table 11; see Beaudoin I, Ex. 1002 at Tables 14-16. This inherency has been
`
`confirmed by Chemir’s and Avanti’s testing of the E. Superba and E. Pacifica
`
`extracts prepared by Dr. Budge. (Ex. 1045, Table 7 of Exhibit A to Expert Witness
`
`Report of Albert C. Lee, Ph.D.; Ex. 1044, Table 11 of Exhibit A to Expert Witness
`
`Report of Jeff D. Moore, Ph.D.)
`
`
`
`
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`132
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`
`
`222. Beaudoin II discloses a krill extract that inherently contains
`
`polyunsaturated fatty acids in an amount of at leas
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