`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________
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`RIMFROST AS
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`Petitioner
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`v.
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`AKER BIOMARINE ANTARCTIC AS
`
`Patent Owner
`
`_______________________
`
`IPR2018-01178
`IPR2018-01179
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`U.S. Patent No. 9,375,453
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`_______________________
`
`
`REPLY AND OPPOSITION
`
`DECLARATION OF DR STEPHEN J. TALLON
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`RIMFROST EXHIBIT 1086 Page 0001
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`U.S. Patent No. 9,375,453
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`TABLE OF CONTENTS
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`
`TABLE OF CONTENTS ........................................................................................... i
`I. DECLARATION OF DR STEPHEN J. TALLON ........................................... 1
`II. BASIS FOR OPINION ...................................................................................... 1
`III.
`‘453 PATENT INVALIDITY GROUNDS, CLAIMS AND AMENDED
`CLAIMS ..................................................................................................................... 6
`‘453 Patent Petition Invalidity Grounds ................................................................ 6
`‘453 Patent Independent Claims Summary ........................................................... 7
`‘453 Patent Amended Claims Invalidity Grounds ................................................. 8
`‘453 Patent Amended Independent Claims Summary ........................................... 9
`IV.
`PATENT OWNER’S VALIDITY ARGUMENTS FAIL ...........................10
`A. PO argues that Catchpole’s Extract 2 does not contain triglycerides, and
`would not have ether phospholipid levels in the claimed range if the required
`triglycerides were added - PO is wrong. ..............................................................10
`B. PO argues that POSITA would not combine the ranges of different krill
`components disclosed by references using extraction methods that PO
`characterizes as selective and non-selective – PO is wrong. ...............................13
`C. PO argues that a POSITA would have been concerned about the possibility
`that ingestion of the ether phospholipids found in krill would have a PAF-like
`effect, and would seek to use lower levels of ether phospholipids in a krill oil
`extract - PO is wrong. .........................................................................................15
`D. PO argues, in support of proposed claim amendments, that the prior art
`does not teach extraction of a krill oil from dried krill meal made by grinding,
`cooking and drying E. Superba – PO is wrong. ..................................................17
`E. PO argues, in support of proposed claim amendments, that the prior art
`does not teach or suggest encapsulated krill oil comprising from 4% to 8%
`(2018IPR-01178) or 5% to 8% (2081IPR-01179) ether phospholipids – PO is
`wrong....................................................................................................................19
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`F. PO argues, in support of proposed claim amendments, that the prior art
`does not teach or suggest a krill oil with an upper bound to astaxanthin esters in
`amount of 700 mg/kg of said krill oil - PO is wrong. .........................................20
`V. PETITIONER’S RESPONSES TO PATENT OWNER’S VALIDITY
`ARGUMENTS .........................................................................................................21
`A. Catchpole’s Extract 2 Has Triglycerides within the Claimed 20% to 50%
`Range....................................................................................................................21
`(i) Applying Fricke To Catchpole’s Extract 2 Krill Oil, A POSITA Would
`Understand That Extract 2 Had Between 32% And 37% By Weight
`Triglycerides. ...................................................................................................21
`(ii)
`PO incorrectly uses Fricke to calculate the amount of neutral lipid
`present in Catchpole’s Extract 2 Krill Oil. ......................................................25
`(iii) Applying Fricke Directly To Catchpole’s Krill Powder Feed, A
`POSITA Would Understand That Extract 2’s Krill Oil Had Between 20-50%
`By Weight Triglycerides ..................................................................................33
`(iv) Tanaka II (Exhibit 1015) Teaches That Like Catchpole After a First
`Extraction “to extract as much of the TGs [triglycerides] as possible” TGs
`remained to be extracted with the PLs in the second step. ..............................45
`(v)
`Catchpole’s Example 18 could be blended with additional PL including
`ether PL to increase the total express amount of ether PL’s to 5% and greater
`without reducing TG content below 20%. .......................................................50
`(vi) Catchpole discloses greater than 5% ether phospholipid krill oil.........51
`B. A POSITA WOULD HAVE BEEN MOTIVATED TO COMBINE THE
`RESULTS OF VARIOUS KRILL LIPID EXTRACTION METHODS AS
`THEY ALL DEMONSTRATE THE NATURAL AND EXTRACTABLE
`COMPONENTS OF KRILL................................................................................57
`(i) PO’s expert, Dr Hoem, has previously expressed a conflicting view......58
`(ii) All extractions are selective. .................................................................60
`C. PAF WAS NO CONCERN TO POSITA IN INCREASING ETHER
`PHOSPHOLIPID CONCENTRATION ..............................................................65
`(i) Prior art cited by PO does not support PAF concern. ..............................66
`(ii) No Mention Of PAF In Three Krill Oil Gras Filings By Different
`Companies Including PO’s GRAS Notification ..............................................90
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`(iii) Motivation to Combine was Strong ....................................................110
`(iv) Prior Art Supports Motivation To Increase Phospholipids And Ether
`Phospholipids And To Combine ....................................................................112
`(v) Murata (Exhibit 1122) Discloses That Large Amounts of Krill Oil
`Were Useful as Platelet Aggregation Inhibitors -The Exact Opposite of the
`effect if Krill Oil Extracts caused an increase PAF or PAF-like activity. .....123
`D. EXTRACTION OF OIL FROM A DRIED DENATURED KRILL MEAL
`PREPARED BY GRINDING, COOKING, AND DRYING WAS WELL
`KNOWN TO POSITA. ......................................................................................125
`(i) Grinding, cooking and drying was a well established practice to a
`POSITA. .........................................................................................................126
`(ii) Breivik and Yamaguchi Do Not Teach Against Grinding, Cooking and
`Drying to Produce a Krill Meal for Extraction of a Krill Oil. .......................132
`E. THE PRIOR ART DISCLOSES AS WELL AS TEACHES HOW TO
`MAKE A KRILL OIL EXTRACT WITH FROM 5% TO 8% ETHER
`PHOSPHOLIPID CONTENT ...........................................................................141
`(i) Catchpole discloses a krill oil extract with at least an ether PL content of
`5.0% in its disclosure of Extract 2 with its 4.8% ether PL content. ..............142
`(ii) Catchpole does not need to add ether PLs as ether LysoPLs would
`increase the 4.8% of Extract 2’s ether PL content. ........................................142
`(iii) Catchpole expressly discloses krill oil ether PL levels greater than 5%
`and a POSITA would have known how to increase Catchpole’s Example 18
`ether PL level of at least 4.8% to 5% and higher. ..........................................143
`(iv) Catchpole teaches how to make krill oil extracts with an ether PL of at
`least 7.4%. ......................................................................................................147
`(v)
`Enzymotec GRAS discloses ether PL content of 5% .........................153
`F. THE PRIOR ART DISCLOSES AND TEACHES KRILL OIL EXTRACTS
`WITH ASTAXANTHIN CONTENT WITHIN THE CLAIMED RANGES OF
`FROM 100 mg/kg, 200 mg/kg, 300 mg/kg and 400 mg/kg to 700 mg/kg. .......154
`(i) A NKO krill oil had 472 mg/kg astaxanthin esters) ..............................154
`(ii) Randolph discloses krill oil compositions with any amount of
`astaxanthin esters including 158 mg/kg astaxanthin esters. ..........................156
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`(iii) Sampalis II (Exhibit 1013) discloses 200 mg/kg and 100 mg/kg
`astaxanthin .....................................................................................................158
`(iv) Motivations to increase, decrease and maintain astaxanthin content. 161
`G. “ABOUT” MEANS AT LEAST ± 0.5% OR ± 2% ..................................164
`(i) “Greater Than About 5%” Means “Greater Than 4.5%”. ......................164
`(ii)
`PO’s Claim Amendments Require that “about” means 1% to 2%. ....167
`H. FRICKE II (EXHIBIT 2006) VALUE FOR ETHER PHOSPHOLIPIDS IN
`KRILL IS TOO LOW, UNHEARD OF AND EVEN THE WAY IT IS
`CALCULATED IS MISLEADING. .................................................................170
`(i) Fricke II Destroys the Ether Phospholipids before Quantifying their
`Amount ...........................................................................................................172
`(ii)
`Fricke II Discloses Different Values of Ether Phospholipid Content172
`(iii) Fricke II Does Not Use a Direct Measurement of Ether Phospholipid
`Content ...........................................................................................................174
`(iv) NMR- The direct method of measuring ether phospholipids. ............177
`(v) A POSITA Would Estimate That Fricke Had a Higher Ether
`Phospholipid Content .....................................................................................181
`CONCLUSION ......................................................................................................183
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`IPR2018-01178
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`I.
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`U.S. Patent No. 9,375,453
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`DECLARATION OF DR STEPHEN J. TALLON
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`
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`1.
`
`
`I make this declaration in support of Petitioner’s Reply to Patent
`
`Owner’s Response to Petition (Papers No. 12) in both IPR2018-01178 and
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`IPR2018-01179 (“POR1178” and “POR1179”).
`
`2.
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`I also make this declaration in support of Petitioner’s Opposition to
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`Patent Owner’s Contingent Motion to Amend the Claims (Papers No. 11) in both
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`IPR2018-01178 and IPR2018-01179 (“MTA1178” and “MTA1179”).
`
`
`II. BASIS FOR OPINION
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`I have reviewed the Declaration of Dr. Nils Hoem, Exhibit 2001
`
`
`3.
`
`(“Hoem Dec.”), and POR1178 and POR1179 and disagree with their conclusions
`
`overall and as described in detail in the discussion below. Furthermore, after
`
`reviewing the foregoing, I hereby reaffirm my opinion from my earlier
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`Declaration, Exhibit 1006, that all claims of U.S. Patent 9,375,453 (“the ‘453
`
`Patent”) would have been obvious to a POSITA in view of the prior art cited.
`
`4.
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`I have reviewed the Declaration of Dr. Nils Hoem, Exhibit 2001
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`(“Hoem Dec.”), and MTA1178 and MTA1179 and disagree with their conclusions
`
`overall and as described in detail in the discussion below.
`1
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`5.
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`In forming my opinion herein, I have relied on my own education,
`
`work experiences and knowledge, see my CV in my declaration, Exhibit 1006,
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`Appendix D, my review of the documents referenced in the Tallon Dec. (Exhibit
`
`1006), and, in addition to my review of POR1178, POR1179, MTA1178,
`
`MTA1179, and the declaration of Dr. Hoem (Exhibit 2001), my review of the
`
`following documents:
`
`
`
`
`EXHIBIT NO.
`
`
`1075
`
`
`1079
`
`
`1089
`
`
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`EXHIBIT DESCRIPTION
`
`Neptune, GRAS Notice [No. GRN 000242] for “High
`Phospholipid Krill Oil”
`https://www.fda.gov/downloads/Food/IngredientsPackagingLab
`eling/GRAS/NoticeInventory/ucm269133.pdf, dated January
`18, 2008 and filed by the FDA February 4, 2008 (Neptune
`GRAS).
`
`Burri, L., Hoem, N., et al., “Fingerprinting Krill Oil by 31P,
`1H and 13C NMR Spectroscopies”, J Am Oil Chem Soc (2016)
`93:1037-1049 (Burri).
`
`Aker GRAS [No. GRN 000371], “Notification of GRAS
`Determination of Krill Oil”, December 14, 2010.
`
`2
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`1090
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`1091
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`1094
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`1095
`
`
`1107
`
`
`1109
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`U.S. Patent No. 9,375,453
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`https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=GR
`ASNotices&id=371
`
`Deposition Transcript of Dr. Nils Hoem (IPR2017-00745, inter
`alia)
`
`Neptune GRAS Agency Response Letter GRN 000242.
`
`Marathe, et al., Inflammatory Platelet-activating Factor-like
`Phospholipids in Oxidized Low Density Lipoproteins Are
`Fragmented Alkyl Phosphatidylcholines, J Biol Chem. 1999
`Oct 1;274(40):28395-28404.
`
`Stremler, et al., Human Plasma Platelet-activating Factor
`Acetylhydrolase - Oxidatively Fragmented Phospholipids As
`Substrates, (1991) J. Biol. Chem. 266, 11095–11103.
`
`Winther, Hoem, et al., Elucidation of phosphatidylcholine
`composition in krill oil extracted from Euphausia superba,
`Lipids. 2011 Jan;46(1):25-36. doi: 10.1007/s11745-010-3472-6.
`Epub 2010 Sep 17.
`
`Aker GRAS Agency Response Letter GRN 000371.
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`1121
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`U.S. Patent No. 9,375,453
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`Declaration by Nils Hoem in Support of Request for Inter
`Partes Reexamaination of U.S. Patent No. 8,057,825, Control
`No. 95/001,819, executed September 16, 2011.
`
`Japanese Laid Open Publication S63-23819 (Murata).
`
`Itano Refrigerated Food Co., Ltd., Bio & High Technology
`Announcement and Natural Astaxanthin & Krill Lecithin, pp.
`1-16, Exhibit 1124 (“Itano”).
`
`
`1122
`
`1124
`
`
`2002
`
`2003
`
`2004
`
`
`
`
`
`2005
`
`
`
`
`
`
`
`
`
`
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`Yamaguchi, K. et al. “Supercritical Carbon Dioxide Extraction
`of Oils from Antarctic Krill”, J. Agric. Food Chem. 1986, 34,
`904-907.
`Prescott, S. et al. “Platelet-Activating Factor and Related Lipid
`Mediators”, Annu. Rev. Biochem. 2000. 69:419-45.
`
`Zimmerman, G. et al. “The platelet-activating factor signaling
`
`system and its regulators in syndromes of inflammation and
`
`thrombosis”, Crit. Care Med 2002, Vol. 30, No. 5 (Suppl):
`
`S294-S301.
`
`Calder, P. “n-3 Polyunsaturated fatty acids, inflammation, and
`
`inflammatory diseases1-3”, Am. J. Clin. Nutr. 2006; 83(suppl):
`
`1505S-19S.
`
`4
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`2006
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`Fricke, H. et al. “1-O-Alkylglycerolipids in Antarctic Krill
`
`
`
`U.S. Patent No. 9,375,453
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`(Euphausia Superba DANA)”, Comp. Biochem. Physiol. Vol.
`
`85B, No. 1, pp. 131-134, 1986.
`
`2008
`
`Zierenberg et al., Intestinal absorption of
`
`polyenephosphatidylcholine in man, J. Lipid. Res. (1982)
`
`23:1136-1142.
`
`2009
`
`Blank et al., Meats and fish consumed in the American diet
`
`contain substantial amounts of ether-linked phospholipids. J
`
`Nutr. (1992) 122(8):1656-61.
`
`2010
`
`Hartvigsen et al., 1-O-Alkyl-2-(w-oxo)acyl-sn-glycerols from
`
`Shark Oil and Human Milk Fat Are Potential Precursors of PAF
`
`Mimics and GHB. Lipids (2006) 41, 679–693.
`
`2011
`
`Marathe et al., Inflammatory Platelet-activating Factor-like
`
`Phospholipids in Oxidized Low Density Lipoproteins Are
`
`Fragmented Alkyl Phosphatidylcholines. J. Biol. Chem. (1999)
`
`274(40):28395-28404.
`
`2020
`
`2022
`
`Transcript of Deposition of Dr. Stephen Tallon, April 2, 2019
`
`Transcript of Deposition of Dr. Stephen Tallon, December 12,
`
`
`
`
`
`2018
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`‘453 Patent Petition Invalidity Grounds
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`6.
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`A summary chart of the ‘453 Patent Petition Invalidity Grounds is
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`included below for reference.
`
`References
`
`Basis
`
`Claims Challenged
`
`
`35 U.S.C. § 103(a)
`
`
`35 U.S.C. § 103(a)
`
`1-3, 5-10, 12, 14-17, 19-
`20, 23-26, 28, 30-38, 40-
`43, 46-49, 51-52, 55-58,
`and 60
`4 and 39
`
`
`35 U.S.C. § 103(a)
`
`
`35 U.S.C. § 103(a)
`
`11, 18, 21, 27, 44, 50,
`53, and 59
`
`13, 22, 29, 45, 54, and
`61
`
`Breivik II, Catchpole,
`Bottino II, and
`Sampalis I
`
`Breivik II, Catchpole,
`Bottino II, Sampalis I,
`and Sampalis II
`Breivik II, Catchpole,
`Bottino II, Sampalis I,
`and Fricke
`Breivik II, Catchpole,
`Bottino II, Sampalis I,
`and Randolph
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`
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`U.S. Patent No. 9,375,453
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`III.
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`‘453 PATENT INVALIDITY GROUNDS, CLAIMS AND AMENDED
`CLAIMS
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`

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`IPR2018-01178
`IPR2018-01179
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`‘453 Patent Independent Claims Summary
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`U.S. Patent No. 9,375,453
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`7.
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`A summary chart of the ‘453 Patent’s Independent Claims is included
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`below for reference.
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`‘453 Patent Claim 1
`
`A method of production of krill oil
`from E. Superba comprising treating
`the E. Superba to denature lipases and
`phospholipases to provide a denatured
`krill product, contacting the denatured
`krill product with a polar solvent to
`extract a krill oil comprising
`phospholipids, said polar krill oil
`comprising
`
`
`
`‘453 Patent Claim 33
`
`A method of production of krill oil
`from E. Superba comprising treating
`the E. Superba to denature lipases and
`phospholipases to provide a denatured
`krill product, contacting the denatured
`krill product with a polar solvent to
`extract a krill oil comprising
`phospholipids, said polar krill oil
`comprising
`
`
`> about 3%
`about 27% to 50%
`about 30% to 60%
`about 20% to 50%
`> about 100 mg/kg
`
`encapsulating said polar krill oil in a
`soft gel capsule.
`
`
`
`
`Ether phospholipids:
`Non-ether phospholipids:
`Total phospholipids:
`
`Triglycerides:
`
`
`Astaxanthin esters:
`
`
`formulating said polar krill oil with a
`carrier for oral consumption
`
`
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`IPR2018-01178
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`‘453 Patent Amended Claims Invalidity Grounds
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`U.S. Patent No. 9,375,453
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`
`
`8.
`
`A summary chart of the ‘453 Patent Amended Claims Invalidity
`
`Grounds is included below for reference.
`
`References
`
`Yoshitomi, Catchpole,
`Bottino II, Sampalis I,
`Sampalis II, Randolph
`and NKO (Applicant
`Admitted Prior Art)
`
`
`Yoshitomi, Catchpole,
`Bottino II, Sampalis I,
`Sampalis II, Randolph
`and NKO (Applicant
`Admitted Prior Art)
`
`
`Yoshitomi, Catchpole,
`Bottino II, Sampalis I,
`Sampalis II, Fricke,
`Randolph and NKO
`(Applicant Admitted
`Prior Art)
`
`Yoshitomi, Catchpole,
`Bottino II, Sampalis I,
`Sampalis II, Randolph
`and NKO (Applicant
`Admitted Prior Art)
`
`Basis
`
`
`35 U.S.C.
`§ 103(a)
`
`
`35 U.S.C.
`§ 103(a)
`
`Amended Claims Challenged
`Amended Claim (Original No.)
`62(1), 63(2), 64(3), 66(5), 67(6),
`68(7), 69(8), 70(9), 71(10),
`73(12)
`
`75(33), 76(37), 77(38), 79(40),
`80(41), 81(42), 82(43),
`
`65(4)
`
`78(39)
`
`
`
`35 U.S.C.
`§ 103(a)
`
`72(11)
`
`83(44)
`
`
`
`35 U.S.C.
`§ 103(a)
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`74(13)
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`84(45)
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`
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`Ground
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`IPR2018-01178
`IPR2018-01179
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`‘453 Patent Amended Independent Claims Summary
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`U.S. Patent No. 9,375,453
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`9.
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`A summary chart of the ‘453 Patent’s Amended Independent Claims
`
`is included below for reference.
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`
`
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`
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`
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`‘453 Patent Amended Claim 62(1)
`
`A method of production of krill oil
`from E. Superba comprising treating
`the freshly caught E. Superba by
`grinding, cooking and drying the E.
`Superba, wherein to denature lipases
`and phospholipases in the E. Superba
`are to provide a denatured by said
`treating krill product, contacting the
`denatured krill product dried krill meal
`with a polar solvent to extract a krill oil
`comprising phospholipids, said polar
`krill oil comprising
`
`
`‘453 Patent Amended Claim 75(33)
`
`A method of production of krill oil
`from E. Superba comprising treating
`the freshly caught E. Superba by
`grinding, cooking and drying the E.
`Superba, wherein to denature lipases
`and phospholipases in the E. Superba
`are to provide a denatured by said
`treating krill product; contacting the
`denatured krill product dried krill meal
`with a polar solvent to extract a krill oil
`comprising phospholipids, said polar
`krill oil comprising
`
`
`
`4% to 8% (claim 62), 5% to 8% (claim 75)
`Ether phospholipids:
`Non-ether phospholipids: about 27% to 50%
`Total phospholipids:
`about 30% to 60%
`Triglycerides:
`
`about 20% to 50%
`Astaxanthin esters:
`
`from 100 mg/kg to 700 mg/kg
`[Some dependent amended claims raise the lower
`astaxanthin limit from 100 mg/kg to 200 mg/kg
`(claim 79), 300 mg/kg (claim 80) and 400 mg/kg
`(claim 81).]
`
`
`formulating said polar krill oil with a
`carrier for oral consumption
`
`encapsulating said polar krill oil in a
`soft gel capsule.
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`U.S. Patent No. 9,375,453
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`IV. PATENT OWNER’S VALIDITY ARGUMENTS FAIL
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`10. Patent Owner (“PO”) asserts several arguments in its Responses to
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`Petitions (POR1178 and POR1179) why its ‘453 Patent claims should not be
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`found to be obvious.
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`A. PO argues that Catchpole’s Extract 2 does not contain triglycerides, and
`would not have ether phospholipid levels in the claimed range if the required
`triglycerides were added - PO is wrong.
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`11. PO asserts that, while Catchpole’s Extract 2 discloses a krill oil
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`extract expressly containing 4.8% by weight ether phospholipids (“ether PL”), that
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`it did not also contain any triglycerides (“TG”). Since triglycerides are required by
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`the claim limitations PO, while admitting that triglycerides could be blended with
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`Catchpole’s Extract 2 to give the required triglyceride content, tries to argue that
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`this would dilute the ether phospholipid content below the claimed range.
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`Therefore, PO, relying on Dr. Hoem, argues that addition of 40% by weight
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`neutral lipids (“NL”), which include triglycerides, would be necessary to arrive at a
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`composition from Catchpole that contains at most 60% phospholipids and that this
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`would reduce the percentage of ether phospholipids from 4.8% to 2.88% ((4.8) x
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`(.6)), and that this falls outside of the claimed range of greater than about 3%.1 See
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`U.S. Patent No. 9,375,453
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`Hoem Dec. ¶¶ 44, 67, 82, 84, 97, 122, 128, 129; POR1178 & POR1179, pp. 5, 20-
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`23; MTA1178, pp. 9, 18; MTA1179, p. 18.
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`12. Alternatively Dr. Hoem argues that 20% triglyceride would need to be
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`added to Catchpole’s Extract 2 to meet the (about) minimum claimed level and
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`calculates that this would reduce the percentage of ether phospholipids from 4.8%
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`to 3.84% ((4.8) x (.8)), which is below the ether PL level of some of the claims.2
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`See Hoem Dec. ¶¶ 67, 122, 128, 129; POR1178 & POR1179, pp. 20, 22, 23;
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`MTA1178, pp. 9, 18; MTA1179, p. 19.
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`13. As discussed below, Catchpole’s Extract 2 does in fact contain
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`triglycerides and importantly a POSITA would have known that Catchpole’s
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`Extract 2 contained triglycerides. PO’s arguments regarding blending and dilution
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`of ether PL are irrelevant as POSITA would understand, in the case of Catchpole’s
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`1 While PO’s overall argument is not valid, as discussed herein, it is noted that
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`even 2.88% is not below the claimed range of greater than 2.5% wt% used in
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`Petitioner’s claim construction for greater than about 3%.
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`2 Similarly, even 3.84% ether phospholipid is not below Petitioner’s claim
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`construction for greater than about 4% which includes greater than 3.5 wt%.
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`Extract 2, that blending is not even required - though it was available if need be.
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`U.S. Patent No. 9,375,453
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`14. Though not included in the Catchpole disclosure, and in contrast to
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`PO’s arguments that there could be no triglycerides in Extract 2, I am personally
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`aware based on chromatographic analysis, contemporaneous with the work
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`performed for Example 18, that Extract 2 does indeed contain triglycerides. See,
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`e.g., Tallon Dep., 181:25-182:12, Exhibit 2022.
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`15. Further, as supported by PO’s own arguments, the value of 4.8% ether
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`PL content reported for Extract 2 does not represent all of the ether PL present, and
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`the actual value will be higher. PO argues that Catchpole’s Example 18 Table 16
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`feed material must contain Lyso-phospholipids (“Lyso PLs”), such as
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`lysophosphatidylcholine (“Lyso PC”). See e.g. Hoem Dec. ¶¶ 62, 73, Exhibit
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`2001. A POSITA would have understood that the polar extraction used to provide
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`Extract 2 must also contain some unreported Lyso PC and that the unreported Lyso
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`PC would be in addition to the reported 4.8% ether PL, bringing the total ether PL
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`level in Catchpole’s Extract 2 to higher than 4.8 wt% krill oil.
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`B. PO argues that POSITA would not combine the ranges of different krill
`components disclosed by references using extraction methods that PO
`characterizes as selective and non-selective – PO is wrong.
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`16. PO argues that a POSITA would not combine ranges for polar lipids
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`obtained from a reference using different extraction methods because “different
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`extraction procedures produce lipid extracts with varying components depending
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`on the solubility of the lipid components in the solvents used in the extraction
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`procedure”. Hoem Dec. ¶ 43, see also ¶¶ 55, 73, 81, 83, 85-90; POR1178 &
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`POR1179, pp. 6, 25, 27-31, 34; MTA1178 & MTA1179, p. 22.
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`17. Dr. Hoem in his declaration, Exhibit 2001, also states that a POSITA
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`would not combine the different prior art references because a POSITA would
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`consider them “unrelated” (¶ 43) and “not interchangeable” (¶ 90). However, Dr.
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`Hoem does not state that a POSITA would not have used these references to
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`inform a POSITA as to all the lipids available for extraction from krill.
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`18. PO’s argument is wrong. All extraction methods are, by nature,
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`selective for some particular compounds, and it is exactly this known selectivity
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`than enables krill oils with a wide range of different compositions to be prepared in
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`a known way. As I discussed in my earlier declaration, a POSITA based on the
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`disclosures from prior art references such as Catchpole (Exhibit 1009), Bottino II
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`(Exhibit 1038), Breivik II (Exhibit 10037), and Fricke 1984 (Exhibit 1010), and
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`other art at the time, which used various extraction methods, would know the
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`U.S. Patent No. 9,375,453
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`relative components of krill oil constituents that could be extracted from krill
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`using these various extraction methods. Moreover, POSITA would have known
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`that the relative proportions of krill oil constituents could be varied in predictable
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`ways by applying these known extraction methods, either singly or in combination,
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`to selectively extract specific groups of lipid components based on their different
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`known solubilities, and by further blending (if required) these selective extracts in
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`known and predictable ways to produce a desired krill oil composition. See
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`Tallon Dec. ¶¶ 104, 106, 438, 443, 449, 458, Exhibit 1006. See also discussion
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`below.
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`19. Moreover, it appears that Dr. Hoem’s position is in conflict with his
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`own previously stated opinion in another proceeding, Inter Partes Reexamination,
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`Control No. 95/001,819 (U.S. Patent No. 8,057,825), in which he argues that
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`extractions using a range of “different extraction protocols”, including mixtures of
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`polar and non polar solvents, can all be used to produce extracts with “common
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`characteristics”.
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`“Lipid extracts from krill have common characteristics. This is
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`demonstrated by the fact that the different extraction protocols
`employed in WO 00/23546 (Tables 14-18), Fricke et al. (Tables 2-6),
`and Gordeev (Table 1) all produce lipid fractions containing
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`phosphatidylcholine and phosphatidylethanolamine as well as other
`phospholipid species, docosahexaenoic acid, eicosahexaenoic acid, and
`oleic acid as well as many other fatty acids. The phospholipid fractions
`utilized by Kuroda (Tables 1 and 2) and described in Makuta (Tables 9
`and 10) also contain these phospholipids and fatty acids. In each
`instance, liposoluble substances such as astaxanthin and a-tocopherol
`would be present in the various krill lipid extracts and phospholipid
`fractions as demonstrated in WO 00/23546 at p. 9-11 and Tables 14-18.
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`Hoem Dec. (95/001,819), ¶¶ 3, 4, Exhibit 1121 (emphasis added). See also
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`more detailed analysis below.
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`C. PO argues that a POSITA would have been concerned about the possibility
`that ingestion of the ether phospholipids found in krill would have a PAF-
`like effect, and would seek to use lower levels of ether phospholipids in a
`krill oil extract - PO is wrong.
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`20. PO argues that a POSITA would have been concerned about the
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`possibility that ingestion of the ether phospholipids found in krill would have a
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`PAF-like effect and thus seek to minimize the amount of ether phospholipids in
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`any krill oil that is extracted, encapsulated and intended for oral consumption to
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`treat conditions associated with inflammation, such as described by Sampalis I
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`(Exhibit 1012). See Hoem Dec. ¶¶ 46, 91-95; POR1178 & POR1179, pp. 6, 32-34;
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`U.S. Patent No. 9,375,453
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`MTA1178 & MTA1179, p. 23.
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`21. PO is wrong. As is discussed in my original declaration there were no
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`concerns of this nature expressed at the time (or since) either from expert panels
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`assessing the health risks of krill oil products, from the results of millions of doses
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`of krill oil products which had already been safely consumed in dosage levels
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`spanning a wide daily range, or from the presence of these same ether
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`phospholipids in common foodstuffs which were and are consumed in significant
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`quantity without health concern. The prior art cited by PO does not change this.
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`The cited prior art makes no causal link between dietary intake of krill ether
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`phospholipids and the pro-inflammatory behaviour of PAF. Even under artificial
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`oxidation conditions, the prior art authors are speculative in their interpretation of
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`the results. This, combined with the low activity of the degradation products
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`compared to true PAF, their low concentration, the proliferation of different
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`degradation products of which the majority have no PAF-like activity, and the
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`body’s natural metabolisation of them to remove them from the body, would
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`provide POSITA with no reason to reduce or otherwise change the ether
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`phospholipid content in a krill oil product due to concern over PAF-like activity.
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`Tallon Dec. ¶¶ 43-63, Exhibit 1006. See further discussion below.
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`D. PO argues, in support of proposed claim amendments, that the prior art does
`not teach extraction of a krill oil from dried krill meal made by grinding,
`cooking and drying E. Superba – PO is wrong.
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`22. PO argues that the prior art does not teach extraction of a krill oil from
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`dried krill meal made by grinding, cooking and drying E. Superba. See Hoem
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`Dec. ¶¶ 103, 124-127, 137; MTA1178 & MTA1179, pp. 13-15, 25.
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`23. PO is wrong. Firstly, the steps of grinding, cooking, and drying are
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`well established in the prior art, including in exhibits such as Yoshitomi (Exhibit
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`1033) and Grantham (Exhibit 1032). See, e.g., Yoshitomi, ¶¶ [0028]-[0034],
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`Exhibit 1033, p. 0006, and Grantham, p. 24, Exhibit 1032, p. 0032. Importantly,
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`both of these references were discussed in my earlier declaration (see Tallon Dec.
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`¶¶ 331-339, 357-366) and were reviewed but not addressed by Dr. Hoem (see
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`Hoem Dec. ¶ 7, Exhibit 2001, p. 8).
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`24. Secondly, extraction of a krill oil from such a krill meal is also
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`obvious and well established in the prior art, as discussed below, and PO’s
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`arguments do not change this. PO cites to selected references, including Breivik II
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`(Exhibit 1037), and Yamaguchi (Exh