’351 Patent
`
`Ex. 1001 at 2:44-50
`Cited in Brenna Decl. (Ex. 1042) at ¶ 55
`
`Ex. 1001 at 4:19-21
`Referenced in Petition at 7
`
`AKBM 1114
`
`1
`1
`
`

`
`G1'm1nd 1: Claims 1-94 anempalemahlelmder 35U_S_IC_ 1()2(h)o1:eIHue:111dI1i11I [EJL
`
`Grm1nd2:C1:1i11:a 1-94 m 1nh 35U_S.{3_102[h)oveIBe:111doi111I [Ex
`
`Ground 3: Claims 1-13, 19-36, 42-59, 65-83, and 89-94 am mapcatclaiahle under 35 U.S_C_
`
`102(1)] over Maruymna (F31 1004)
`
`28
`
`Ground 4: Claims H5, 9, 12-14, 19-29, 32, 35-31‘, 42-52, 55, 58-ED, 65-T5, ‘I9, 82-84, and
`
`59-94 3I‘€1I[Ip:IICI.'l1ablE under 35 U.S_C. 1(}2['b] over Fujita [E1 1|3I‘.)5]_.___ 33
`
`Gmund 5: Claims 1-6, 9, 19-29, 32, 42-52, 55, 65-16, ‘I9, and 39-94m tunic:
`
`Grmmd 0: Claims 1, 1221, 24, 4244, 4? and 05-02 are unpateniablc lmder 35 11.5.4:
`
`1020:) over Rogazhin (Ex 10011)
`
`44
`
`G11:n1nd}':C1:11'11:|s 1-94 ariennpatentableluldet 35USC 1[}3[a)oveIBea11doinIi111.'iEtIrof
`
`{}1'm1n:18:C1:11'1ns1-94 arvennpatentahlelltuiet 351131: 1[}3[a]oveIHea11dt1inI{E1(_ 1002)
`
`in View arm: Final Pm5pc4'.:t115 (E3. 1011), 2001 Press 1:21:44: (E1; 1012) and Huge1son
`
`{E11017155
`
`I|I}1'uum19:C1:11'1n5 1:94 anennpatentablelltuiet 351151: 10300 -0-ve;rF11jita [E1 1005) in
`
`view orwamuabe [Ex 1fl39],:11:u1 may invinw ufltan-0 (E1c_1fl(l9)a1:uiYasawa (Ex
`
`1015154
`
`Gmund 19: Claims 1—94am11rq1a1cI:Itable1n14i:I 35 USC 1{13{a] o'I.rerFriJ:kc [E1 1000) in
`
`uiewofflergnrlson [E1 1fl1TJ, and:fi1rtherin1ri:ewofYa5:nI::1 [E1 1015}, It:1nn (EJ111139)
`
`AKBM 1114
`AKBM 1114
`
`Petition at i-ii
`Petition at i-ii
`
`2
`2
`
`

`
`Neptune’s Expert
`
`Ex. 1093 (J. Jaczynski 10/15/13 Dep. Tr.) at 57:23-25
`Cited in Reply at 5
`
`Ex. 1093 (J. Jaczynski 10/15/13 Dep. Tr.) at 60:2-5
`Cited in Reply at 12
`
`AKBM 1114
`
`3
`3
`
`

`
`Free Fatty Acid Concentration (Claims 5, 28)
`
`Ex. 1001 (’351 Patent) at 21:61-64
`Cited in Petition at 10; Reply at 3
`
`Ex. 1001 (’351 Patent) at 16:46-47
`Cited in Reply at 3
`
`Ex. 1001 (’351 Patent) at Table 5 (17:52-18:6)
`Cited in Reply at 3
`
`AKBM 1114
`
`4
`
`

`
`Suitable For Human Consumption
`
`* * *
`
`Ex. 1001 (’351 Patent) at Claim 70
`Cited in Reply at 2
`
`Ex. 1001 (’351 Patent) at 20:34-41
`Cited in Reply at 2
`
`AKBM 1114
`
`Ex. 1097 (J. Jaczynski 8/27/14 Dep. Tr.) at 222:7-19
`Cited in Reply at 2
`
`5
`
`

`
`Solution
`
`* * *
`
`Ex. 1097 (J. Jaczynski 8/27/14 Dep. Tr.) at 85:14-25
`Referenced in Reply at 3
`
`AKBM 1114
`
`6
`
`

`
`“Claim terms are generally given their plain and ordinary meanings to
`one of skill in the art when read in the context of the specification and
`prosecution history. There are only two exceptions to this general rule: 1)
`when a patentee sets out a definition and acts as his own lexicographer,
`or 2) when the patentee disavows the full scope of the claim term either
`in the specification or during prosecution.”
`
`Hill-Rom Services, Inc. v. Stryker Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014) (internal citations, quotations omitted)
`
`Cited in Reply at 2
`
`AKBM 1114
`
`7
`7
`
`

`
`BEAUDOIN
`
`BEAU DOIN
`
`AKBM 1114
`AKBM 1114
`
`8
`
`

`
`‘351 Patent
`
`Beaudoin I
`(Section 102(b) Prior Art)
`
`Ex. 1001 (‘351 Patent) at 18:32-36
`Cited in Reply at 5; Brenna Decl.
`(Ex. 1042) at ¶ 63
`
`AKBM 1114
`
`9
`
`

`
`Fraction I
`
`AKBM 1114
`
`Ex. 1042 (Brenna Decl.) at ¶ 63
`Cited in Petition at 12
`
`10
`
`

`
`“[J]ust as the discovery of properties of a known material does not make
`it novel, the identification and characterization of a prior art material also
`does not make it novel.”
`
`In re Crish, 393 F.3d 1253, 1258 (Fed. Cir. 2004)
`
`Cited in Petition at 11
`
`AKBM 1114
`
`11
`11
`
`

`
`* * *
`
`AKBM 1114
`
`Ex. 1063 (1/5/12 Office Action, ’351 Pros.) at ¶ 7
`Cited in Petition at 5
`
`12
`12
`
`

`
`* * *
`
`Ex. 1100 (Notice of Allowance, ’348 Pros.) at 1-3
`Cited in Reply at 6
`
`AKBM 1114
`
`13
`13
`
`

`
`* * *
`
`Ex. 1061 (Resp. to 1/5/12 Office Action, ’351 Pros.) at 33
`Cited in Reply at 6
`
`AKBM 1114
`
`14
`14
`
`

`
`Neptune’s Tests: “White 1” (2009)
`
`AKBM 1114
`
`15
`15
`
`Ex. 1098 (White 2009 Report) at 1
`Cited in Reply at 6
`
`Ex. 1098 (White 2009 Report) at 3
`Cited in Reply at 6
`
`

`
`Neptune’s Tests: “White 2” & “White 3”
`(2011)
`
`Ex. 1051 (White 2011 Decl., ’348 Pros. and ’351 Pros.) at 0000018
`Cited in Petition at 5, 13; Reply at 6; Brenna Decl. (Ex. 1042) at ¶¶ 178, 216,
`383
`
`“White 2 and 3”
`
`Ex. 1051 (White 2011 Decl., ’348 Pros. and ‘351 Pros.) at 0000020
`Cited in Petition at 13, Reply at 6; Brenna Decl. (Ex. 1042) at ¶¶ 178, 216, 383
`
`AKBM 1114
`
`16
`16
`
`

`
`Neptune’s Expert
`
`* * *
`
`Ex. 1054 (Yeboah Decl., ’348 Reex.) at ¶ 36
`Cited in Petition at 13, 20, 25
`
`AKBM 1114
`
`17
`17
`
`

`
`Analysis of Neptune’s Samples
`
`Ex. 1109 (van Breemen Witness Stmt.) at 100
`Cited in Reply at 6
`
`AKBM 1114
`
`18
`18
`
`

`
`Analysis of Neptune’s Samples
`
`AKBM 1114
`
`19
`19
`
`Ex. 1109 (van Breemen Witness Stmt.) at 102
`Cited in Reply at 6
`
`

`
`Analysis of Neptune’s Samples
`
`Ex. 1109 (van Breemen Witness Stmt.) at 103
`Cited in Reply at 6
`
`AKBM 1114
`
`20
`20
`
`

`
`WOIILD |N1'ELLE{'.'I'lJAL FIOFEITY URC|ilN"|ZI'.1'[lJ}l
`uumuioml ‘Bun-an
`PCT
`INTERH.I\TiDN-‘KL APPLICAHON ?U'BU5H'ED UNDER THE P-I\'I"E‘iT CUOPERATION TREK-[Y
`[513 [|1t¢rl|l.Iian.iIPI!!l|IC1.I!ti.ICfli6l'| 7 :
`(ll: lnturrialhonal Puhluatiou Nuinlm-.
`CIIB lflfl. C1231 ‘MS-It
`[I11 ‘intern-miuual !’uh1iii:a|i.m Dal»:
`
`1'? Awri'- 33313 l'1TJZ|-I-03}
`
`rcricmgmaeai
`an imimniimi Application number.
`[22] International Filing Date:
`2| Oclelm I999 I.’"3I.lD.Wl
`
`rm Delipnlrd st-in-r AF. Al. AM. AT. AU. AZ. BA. BB. 86.
`BR. HY. C-L CH. Di, CI. CU. Cl’. DE. DIL DM. EB.
`
`l
`
`{JD} Priar.'I._j' Data‘.
`1.35| 3356
`
`1| Utlfilltf W93 lT|.i|J'35i
`
`L"):
`
`fl1]}A,Fp!'clI'|! flbrdfifexignalsid Sum: (Map! um: I.|.~inrEu5n'E
`DE 5|‘-'ERERDDK.E lCN'Ch1'. Ul|il|:r5i‘L}' Buulcvlril. Shu-
`brmke. Queltcc IIK 25!! [CR]
`{T31 1m-enrol‘: Hld
`[T5}In1Aenlr>rfl'.A1i|llii.III|-5 {iiv Us nah-J: _ Adricali
`|C}\uH'.!.i'-1|. 1%.
`lxiulinmtlt den Véndmnl. Rock Fell“. Qne-
`be: {IN 121 (CA). ht.\l'i'.'l'IH', 'Bd|.|!|IiEU': [¢.vC.r,]; 790,
`MGMIIIHIJ’. Slwhwfite. Quebec Ill-I 2N1 (C-M.
`[1-IJ Aaetlt D1.iBLlC.lun. I-L ei 1.1.: Gaudaezu {I-us: Dubai: 6':
`Milltiteai Wallier. The 5l.u:'k Ending: Thur. Suits 3-I33,
`I'D. Boil 242. 800 Place '~'ictuI'iI.. MnciLruL.Qusl:ie.c Ha
`IE9 [CAL
`
`11. 1'1. mp. Eumpaan pun: (A1:
`n.
`Di<,Es. ‘FE, FR. an. :31 IE. IT. LU.
`PI: mm {BE Bl. CF. CG. CI. CM.
`
`1'-'-I-tinted
`'ll"I'Ih bums.-.riwial .:a.u.i-dc rapnri.
`Before we up-iii-miauu qfiilae flu: Iémlr for nun.-dug aloe
`chills! and to be I-qpu£Il'i|'luid in It: awn: DI-n’Il receipt qt
`am-nshuuu.
`
`[5-1} 'Iil'JE METHOD OF EXTRACHNG LIPIDG FROM MARIFIE AND AQUATIC ANIMAL "[‘lSSUE8
`[ff] Alziisraaat
`'_|'|i¢
`Pioi-'ir.l:d herein is 2 rlleihnd lot utrxiung Ilpla l'ra.i:.lpm fmm marina mil nquaxii; aninm n1aq:ria| by among e.|I11I:|[ur|,
`tesuitirtg ni<u1—.1®l:'|e and plnicidaie fIa.oi.i'm iipiielicililiily Itlbjttwd an in sddldnml wing-ugqgqpfig. w|,|h maipuhoi, prglgqmg cu-um1_
`impmpanol. or I-buunal or an csiier of bani: add. prelieralaly ethyl unease. no Iehlate exiractlm ofliicrcinainlng soluble ipifl mmim rrun
`lb: marine and aqiuliis animal tmn-rial. The mmiinini; nun-soluble -prauiicnlane eumenu il lilo reouurad ainnu ill is en:-Bchgd in pmtging
`and Icontlills I LIsr—1|I| amflurrl of active en:;rm|:5. Aim nr:-vidsd henii is a krl.|| eblnu.
`
`Neptune Technologies 3.: Bioressuurces Inc.
`In formation PM Image
`
`Table of Contents
`
`1. General infurrnalinn requested
`
`2. Appendix A : Phntustatii: l.LI‘Jpit:E or reprints uftili: Full-published rL'fi:renees,
`
`citations. and artieleii in English:
`a. Krill
`
`Cardiovascular disease
`
`lnflammatorg-' disease
`
`Plmsphu-lipids
`
`e. A.staxa.niJ1in
`
`Appendix B : Neptune Krill Oil“ serving and daily dose
`
`Appendix C : Neptune Aquamimm serving and dailydmc
`
`Appimdix D : L},rD-Krill daily .-i.i::1'-iring and 'lIi:IJ'i.~lE.l
`
`fiiippendix E: Neptime Krill Enzymes-M serving and daily dose
`
`Appendix F: Seientifie Report
`
`_ a
`
`- —& Neptune eqlmieinem
`
`h.
`
`i_},rCI-K_ril1
`
`9. Appendix H: Krill additive by Nippon Suisan
`
`AKBM 1114
`AKBM 1114
`
`Ex. 1107 at 7, 94-155
`Ex. 1107 at 7, 94-155
`Cited in Reply at 5
`Cited in Reply at 5
`
`21
`
`

`
`Fraction I
`
`AKBM 1114
`
`22
`
`Ex. 1042 (Brenna Decl.) at ¶¶ 63, 77; Ex. 1002 (Beaudoin I) at 10:19-20
`Cited in Petition at 12; Reply at 9
`
`

`
`Q Dr. Jaezyuiski. following the procedure of
`the Beaudoin I patent is it your position that the
`
`claimed phospholipids would be in the extract prior to
`the 125 degree Celsius heating step?
`A Yes.
`
`<
`
`
`
`A —
`Q How 111311}? of the claimed phospholipid
`
`nioleeules would be left in the extract after the
`
`heating step‘?
`
`A I don't lmow.
`
`Ex. 1093 (J. Jaczynski 10/15/13 Dep. Tr.) at 179:25-180:13
`Ex. 1093 (J. Jaczynski 10/15/13 Dep. Tr.) at 179:25—180:13
`Cited in Reply at 5
`Cited in Reply at 5
`
`5 1
`
`3 4 5 E 7
`
`" 8
`
`AKBM 1114
`AKBM 1114
`
`23
`23
`
`

`
` n
`
`ahnut 125°C. fer aheut '15 min} the nail under nitregen.
`
`Ex. 1002 (Beaudoin I) at 7:18-19
`Ex. 1002 (Beaudoin I) at 7218-19
`Cited in Brenna Decl. (Ex. 1042) at ¶¶ 77, 376
`Cited in Brenna Decl. (Ex. 1042) at flfl 77, 376
`
`One er the inventors. Dr. Adrien Eeeudein. _the different lipid freetiene
`
`Hfkrill-—
`
`Ex. 1002 (Beaudoin I) at 12:13-14
`Ex. 1002 (Beaudoin I) at 12:13-14
`Cited in Petition at 19; Brenna Decl. (Ex. 1042) at ¶¶ 78, 179
`Cited in Petition at 19; Brenna Decl. (Ex. 1042) at 1m 78, 179
`
`AKBM 1114
`AKBM 1114
`
`24
`24
`
`

`
`Summary
`
`The summary of test results for the 11 samples in this report is provided in table 11.
`
`Table ll: Results sumnlary in weight % :t standard deviation.
`0 Total Lipid
`nmmPL
`I
`8l8i5J lasso;
`VB 1 3,I'8f13 FH
`34.2i2.3
`3310.5
`
`Free FA
`
`VB 7 3;'9f13 FHE
`
`BEA SB1 PO
`
`61.6 i 0.8
`
`A 535 1
`
`_
`
`59.6 i 1.9
`
`BEA SU2
`
`Accuracy
`
`31.02 i 0.07
`
`31.51 i 0.12
`44.40 '1‘ 0.48
`
`__ _0.10 t 0.01
`
`28.72 -1 0.74
`
`29.24 i 0.96
`
`43.70 i 1.50
`
`Ex. 1044 (Moore / Avanti Decl.) at 0000018
`Ex. 1044 (Moore / Avanti Decl.) at 0000018
`Cited in Petition at 16; Reply at 10; Brenna Decl. (Ex. 1042) at ¶¶ 180, 181, 187, 209
`Cited in Petition at 16; Reply at 10; Brenna Decl. (Ex. 1042) at 111] 180, 181, 187, 209
`
`AKBM 1114
`AKBM 1114
`
`25
`25
`
`

`
`Total Phospholipids (Claims 2, 3, 25, 26)
`
`* * *
`
`AKBM 1114
`
`Ex. 1041 (Budge Decl.) at ¶ 10
`Cited in Petition at 11, 14, 18; Reply at 10,
`12; Brenna Decl. (Ex. 1042) at ¶ 81
`26
`
`

`
`Total Phospholipids (Claims 2, 3, 25, 26)
`
`Ex. 1044 (Moore / Avanti Decl.) at 0000018
`Cited in Petition at 16; Reply at 10; Brenna Decl. (Ex. 1042) at ¶¶ 180, 181, 187, 209
`
`AKBM 1114
`
`27
`
`

`
`Free Fatty Acid Concentration (Claims 5, 28)
`
`* * *
`
`* * *
`
`* * *
`
`Ex. 1097 (J. Jaczynski 8/27/14 Dep. Tr.)
`at 285:20-286:7, 322:8-16
`Cited in Reply at 12
`
`28
`28
`
`AKBM 1114
`
`

`
`BACKGROUND OF THE |I'W'ENTlDN
`
`This invention relates to the extraction of lipid fractions from marine and aquatic
`
`animals such as lm‘t|. Calanus. fish and sea rnemmals. More specifically, this
`
`invention relates to an improved method of extracting lipid fractions by dehydration
`
`with solvents and recovering a solid residue rich in active enzvmes.
`
`Lipid fractions obtained from marine and aquatic animals such as lrrill. Calanus, fish
`
`and sea mammals have various applications:
`
`Marine and aquatic. animal oils and fractions thereof contain various therapeutic
`
`agents. For example. it is reported that venous marine and aquatic aninal oils have
`
`anti-inflammatory properties. l'vlan'ne and aquatic animal oils are also reported as
`
`helpful in reducing the incidence of cardiovascular disease. Also, some marine and
`
`aquatic animal oils are reported as suppressing the developmerlt of certain fomts of
`
`lupus and renal diseases. As a further example. lrrill may be used as a source of
`
`enzymes for detlridement of ulcers and vrounds or to facilitate food digestion. Also
`
`marina and aquatic oils.
`
`r.‘:I:rt'Itai11 'v'ariI:rua antioxidants, which may have potential
`
`therapeutic properties.
`
`Considering the beneficial effects ofomega-3 fatty acids, oils from krill, Galleries and
`
`frsh could be used as distant supplements to human diet. These fatty acids are
`
`essential for proper development of the brain and the eve. Marine and aquatic
`
`animal oils are also rich in lipcscluhls vitamins A, El and E and carotencids_
`
`Various marine and aquatic animal oils are used for the production of moisturizing
`creams.
`
`Ex. 1002 (Beaudoin I) at 1
`Ex. 1002 (Beaudoin I) at 1
`Cited in Petition at 16; Brenna Decl. (Ex. 1042) at ¶¶ 68, 78, 354
`Cited in Petition at 16; Brenna Decl. (Ex. 1042) at flfl 68, 78, 354
`
`AKBM 1114
`AKBM 1114
`
`29
`29
`
`

`
`Scmlvcnts in {SIMS 3 ("l".ahJL: 3) may be I'L:gardt;:c! .515 1055: toxic and uI'|uwc:1'ri:ii-: bu human hcallh.
`C 32:55 3 iJ1Cil|Cif.‘.'3 no suivciit klmwn as 21 human Ilealth llazard al 16:ve-ls I1.01‘mal|}' accepted in
`pl1a1'1n:-xcelllicuis. HLW.-'I;‘.|.'I:Jl', lhcre are no IOng—1t3rm toxicll}-' or can:i:10ge11[ciI_v .-studies For mm13.-'
`ufthc solvents in Class 3. Available dahlai
`'
`'
`‘
`*
`'
`'* ’
`-
`‘
`*
`Sillliiflfi and In: ralivu En =<:11uL:'::<iC:ilv studic.
`
`are l"I.3':l 15 IL: 111 11:
`
`:1 Ion 0 munu ac urmg capa 1
`
`I
`
`3:" am gnu Imnlu ‘
`
`‘
`
`provide-;i 1.'i1f'.'}-'
`prac: 1 ‘E {{JM?‘,I.
`
`Table 3. — Class 3 Solvents Whicll Slmuld Be Limited by GMT’ or Other Quality-Based
`Rcqtlircmenls
`
`—
`
`Tie]:-tam:
`
`isuhIII_'.'] ac-stale
`
`Ex. 1095 (USDA / FDA Guidance for Industry) at 7
`Ex. 1095 (USDA/ FDA Guidance for Industry) at 7
`Cited in Reply at 10
`Cited in Reply at 10
`
`10.0% x 300mg = 30mg
`30mg per day < 50mg per day
`
`EX. 1106
`Ex. 1106
`Cited in Reply at 10
`Cited in Reply at 10
`
`AKBM 1114
`AKBM 1114
`
`30
`30
`
`

`
`Neptune’s Expert
`
`Ex. 1097 (J. Jaczynski 8/27/14 Dep. Tr.) at 219:6-11
`Cited in Reply at 10
`
`AKBM 1114
`
`31
`
`

`
`Additional Lipid (Claims 4, 27)
`
`AKBM 1114
`
`Ex. 1002 (Beaudoin I) at 23
`Cited in Petition ta 20; Brenna Decl. (Ex. 1042) at ¶¶ 72, 182
`
`32
`
`

`
`PUFA Concentration (Claims 6, 29)
`
`* * *
`
`* * *
`
`4.4
`5.4
`12.6
`18.8
`13.2
`54.4
`
`+
`
`AKBM 1114
`
`Ex. 1002 (Beaudoin) at 23-25
`Cited in Petition at 21; Brenna Decl. at ¶¶ 73, 184
`
`33
`
`

`
`Omega-3 Fatty Acids (Claims 9, 32)
`
`* * *
`
`* * *
`
`3.2
`0.1
`0.9
`9.2
`0.7
`17.4
`0.7
`0.5
`13.2
`45.9
`
`+
`
`AKBM 1114
`
`Ex. 1002 (Beaudoin) at 23-25
`Cited in Petition at 21; Brenna Decl. (Ex. 1042) at ¶ 187
`
`34
`
`

`
`Metals / Zinc or Selenium (Claims 12, 13, 35, 36)
`
`E. Pacifica / no heat
`
`E. Pacifica / 125° C heat
`
`E. Superba /no heat
`
`E. Superba /125° C heat
`
`Ex. 1045 (Lee / Chemir Decl.) at ¶ 5
`Cited in Petition at 15-16
`
`AKBM 1114
`
`35
`
`

`
`Metals / Zinc or Selenium (Claims 12, 13, 35, 36)
`
`Ex. 1045 (Lee / Chemir Decl.) at 17
`Cited in Petition at 21; Brenna Decl. (Ex. 1042) at ¶ 190
`
`AKBM 1114
`
`36
`
`

`
`Antioxidant / Astaxanthin (Claims 22, 23, 45, 46)
`
`Ex. 1002 (Beaudoin) at 27
`Cited in Petition at 19; Brenna Decl. (Ex. 1042) at ¶ 201
`
`AKBM 1114
`
`37
`
`

`
`Antioxidant / Astaxanthin (Claims 22, 23, 45, 46)
`
`Ex. 1045 (Lee / Chemir Decl.) at 17
`Cited in Brenna Decl. (Ex. 1042) at ¶ 201
`
`AKBM 1114
`
`38
`
`

`
`Neptune’s Expert
`
`Ex. 1088 (J. Jaczynski 8/27/14 Dep. Ex. 5)
`Cited in Reply at 8
`
`Ex. 1089 (J. Jaczynski 8/27/14 Dep. Ex. 7)
`Cited in Reply at 8
`
`AKBM 1114
`
`39
`
`

`
`FRICKE, BERGELSON, YASAWA, ITANO,
`FRICKE, BERGELSON, YASAWA, ITANO,
`& THE WHO BULLETIN
`
`& THE WHO BULLETIN
`
`AKBM 1114
`AKBM 1114
`
`40
`
`

`
`Krill samples of 5 kg were quick-frozen and
`stored at ‘"35 C until analyzed. Subsamples pre-
`pared from the eore of the 5 kg samples were
`homogenized in a mortar under liquid nitrogen,
`and
`— Lipids were dissolved in
`diehloroniethane: methanol
`1:]
`{v,?1r)
`and
`stored under a nitrogen atmosphere at -23 C.
`
`Ex. 1006 (Fricke) at 821
`Ex. 1006 (Fricke) at 821
`Cited in Petition at 39; Brenna Decl. (Ex. 1042) at ¶¶ 121, 280, 281
`Cited in Petition at 39; Brenna Decl. (Ex. 1042) at flfl 121, 280, 281
`
`Q Do jsou 1-mow I:r_iha'L
`would not er-'.l1'ae1; the claimed pliospholipids tiom
`krili?
`
`A No.
`
`Ex. 1093 (J. Jaczynski 10/15/13 Dep. Tr.) at 60:2-5
`Ex. 1093 (J. Jaczynski 10/15/13 Dep. Tr.) at 6022-5
`Cited in Reply at 12
`Cited in Reply at 12
`
`at p. 821. The Fricke Aiticle discloses the claimed phosphc-lipid.-
`
` F111‘ther. to the extent the ‘.351 patent discloses the
`
`AKBM 1114
`AKBM 1114
`
`Ex. 1042 (Brenna Decl.) at ¶ 280
`Ex. 1042 (Brenna Decl.) at 1] 280
`
`41
`41
`
`

`
`Neptune’s Provisional Application
`
`Fricke
`
`* * *
`
`* * *
`
`* * *
`
`PO Response at 15-16
`
`AKBM 1114
`
`Ex. 1006 (Fricke) at 821, 823, 826
`Cited in Petition at 39-41; Brenna Decl. (Ex. 1042) at ¶¶ 121, 286-288
`42
`42
`
`

`
`TABLE E:
`
`1-'stt_-.= Acid Positinnsi Analysis in l“htJsphstidy|ch-slim:
`{PC} and Phusphatidylethallrriamine {PE}
`nfEupimus£u Sup-E!‘fl|-El Dana {19’.'? Sample}
`
`Phuspholipid
`
`PL".
`
`PE
`
`— I Z _ I I
`
`1410
`IE:-:E|
`
`lt‘-:1[n-‘3".|e
`13:0
`
`13:l{n-1'}
`lfi:1{n-9}
`
`lE:2in-fii
`
`Dth ers
`
`2.
`4.
`5.
`I}.
`L1‘
`
`«"1!-It--Il.u|
`4.mm.‘
`
`3.
`
`Id-
`
`.
`
`2 I .
`
`Data are expressed as wt
`;msi1:irm from I:_'.|-FIE I.=.J{peri1'nent_
`
`of fatty acids in one
`
`Ex. 1006 (Fricke) at 826
`Ex. 1006 (Fricke) at 826
`Cited in Petition at 57; Brenna Decl. (Ex. 1042) at ¶¶ 280, 397
`Cited in Petition at 57; Brenna Decl. (Ex. 1042) at flfl 280, 397
`
`AKBM 1114
`AKBM 1114
`
`43
`
`

`
`Brenna Decl. (Ex. 1042) at ¶ 281
`Cited in Petition at 41
`
`AKBM 1114
`
`44
`
`

`
`Table 2. — Class 2 Snlvents in Pharmaceutical Prmlucts
`
`PIJE [n1gIda:r}
`:1. I
`
`Cunccntnuion Limi1{_ppm}
`4 1D
`
`351}
`
`3.6
`
`33.3
`
`11?
`
`Sulvenl
`
`Acciunitrilc
`
`Ch In mhcnze ru:
`
`: C
`
`ycluhexan :2
`
`Cu m Izn-5
`
`I,2—lJi::]1|nrm=:tI1e:1e
`
`Dichlnrumcthane
`
`I ,2~II'JI'rt:H.=:t!m:o::-,r1:1‘I:I am:
`
`N,N‘D imethy Lac:-.tam i r] E
`
`N.N—Uimeth}r[forn1aInEde
`
`I ,4-Dinxane
`
`2—Ethnx'_I,r£:1hancrl
`
`Eflwylmeglycul
`
`Furmarnide
`
`Hcmnr
`
`AKBM 1114
`AKBM 1114
`
`45
`
`Ex. 1095 (USDA / FDA Guidance for Industry) at 6
`Ex. 1095 (USDA/ FDA Guidance for Industry) at 6
`Cited in Reply at 13
`Cited in Reply at 13
`
`

`
`KRILL LECITHIN
`
`PHOSPHOLIPID I
`
`Phospholipid, a structural component of organic membranes. contributes
`to enzyme activation and is said to be effective in lowering the conc:ontra-
`
`tiii
`
`in human blood.
`
`_
`
`Ex. 1009 (Itano) at 15
`Ex. 1009 (ltano) at 15
`Cited in Petition at 56, 58; Brenna Decl. (Ex. 1042) at ¶¶ 123, 125, 354, 397
`Cited in Petition at 56, 58; Brenna Decl. (Ex. 1042) at flfl 123, 125, 354, 397
`
`Anblew Refreshing-Seasoning —- -
`Krill Extract
`— This -.-tram." '
`teristic is accounted for by its excellent balance of flavour
`producing amino acids —-_ nlanlne. glycine.
`serlrre,
`glutamic acid - "and aroma producing amino acids _—
`leucine. proline. lysine and nspartic acid. Further. krill‘
`contains glucossmine hydrochloride and methionol,
`components which produce a distinctive flavour and
`aroma respectively. On the other hand, these compo-
`nents do not produce excessive flarour but are character-
`ized by a
`leasant fadin away of any aftertastes.
`
`Tripoptlde — Effective-in Checking High
`Blood Pressure.
`In addition to its omstandin
`ro ertiesas n seasonin ,
`_ One of these is a Iripeptide with
`
`.
`
`a configuration of Ieuclne, lysine and triptophan: this
`tripeptide serves to inhibit enzyines which torn: angio-'
`E tensin,-at substance that is known to be responsible for
`raising blood pressure. Various other features such as
`small molecules, which allow easy abso lion In the
`mall intestines make an m e (Nah
`":—-so
`
`AKBM 1114
`AKBM 1114
`
`Ex. 1009 (Itano) at 7
`Ex. 1009 (ltano) at 7
`Cited in Reply at 14; Brenna Decl. (Ex. 1042) at ¶¶ 125, 399
`Cited in Reply at 14; Brenna Decl. (Ex. 1042) at flfl 125, 399
`
`46
`
`

`
`fltmlfifi cunlins flf ihfl f=‘"'-"-Pflfififlfi 1'¢E5'-‘~1.
`
` H5p1:-I::ia]1}F Ifllm flu: lipid: are spmad as 11 t.'II.in film
`an the waif: ufttue: flash Tu aaruid p:n;::n:i+:l:. f-u-mufinn it is mmmmnndcd tn add
`a frnsh pnni-an 111' anti-axidmt bcfl:-rc evzp-urafimL
`
`Ex. 1017 (Bergelson) at 10
`Ex. 1017 (Bergelson) at 10
`Brenna Decl. (Ex. 1042) at ¶¶ 46, 153, 365, 392, 397
`Brenna Decl. (Ex. 1042) at flfl 46, 153, 365, 392, 397
`
`AKBM 1114
`AKBM 1114
`
`47
`
`

`
`Total Phospholipids (Claims 2, 3, 25, 26)
`
`Ex. 1006 (Fricke) at 822
`Cited in Brenna Decl. (Ex. 1042) at ¶¶ 282-83
`
`AKBM 1114
`
`48
`
`

`
`Total Phospholipids (Claims 2, 3, 25, 26)
`
`Ex. 2059 (Jaczynski Decl.) at ¶ 112
`See Reply at 14 and n.4
`
`39.6
`
`41.13
`
`Ex. 1006 (Fricke) at 822
`Cited in Brenna Decl. (Ex. 1042) at ¶¶ 282-83
`
`AKBM 1114
`
`49
`
`

`
`Additional Lipid (Claims 4, 27)
`
`AKBM 1114
`
`Ex. 1006 (Fricke) at 822
`Cited in Petition at 42, 58; Brenna Decl. (Ex. 1042) at ¶¶ 284, 398
`
`50
`
`

`
`Free Fatty Acid Concentration (Claims 5, 28)
`
`Ex. 1006 (Fricke) at 822-23
`Cited in Brenna Decl. (Ex. 1042) at ¶ 285
`
`AKBM 1114
`
`Ex. 1006 (Fricke) at 822
`Cited in Petition at 42, 58; Brenna Decl. (Ex. 1042) at ¶¶ 285, 398
`
`51
`
`

`
`PUFA Concentration (Claims 6, 29)
`
`0.82
`0.74
`1.58
`0.47
`0.21
`0.67
`0.46
`12.71
`0.42
`0.54
`+
`5.41
`24.03
`
`AKBM 1114
`
`Ex. 1006 (Fricke) at 823
`Cited in Petition at 43; Reply at 15 n.5; Brenna Decl. (Ex. 1042) at ¶¶ 286, 398
`
`52
`
`

`
`Omega-3 Fatty Acids (Claims 9, 32)
`
`0.74
`0.47
`0.67
`0.46
`12.71
`0.42
`0.54
`+
`5.41
`21.42
`
`AKBM 1114
`
`Ex. 1009 (Fricke) at 823
`Cited in Petition at 41, 43; Reply at 15 n.5; Brenna Decl. (Ex. 1042) at ¶¶ 287, 398
`
`53
`
`

`
`Metals / Zinc or Selenium (Claims 12, 13, 35, 36)
`
`Ex. 1018 (WHO Bulletin) at 000005
`Cited in Petition at 58; Brenna Decl. (Ex. 1042) at ¶ 399
`
`AKBM 1114
`
`54
`
`

`
`Antioxidant / Carotenoid / Astaxanthin
`(Claims 22, 23, 45, 46)
`
`AKBM 1114
`
`Ex. 1006 (Fricke) at 822
`Cited in Petition at 41, 43; Brenna Decl.
`(Ex. 1042) at ¶¶ 292, 300, 398
`
`55