IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ENZYMOTEC LTD.,
`Petitioner
`
`
`
`v.
`
`
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.,
`Patent Owner
`
`
`
`CASE: IPR2014-00586
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT 8,278,351
`UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`Mail Stop “PATENT BOARD” Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ENZYMOTEC LTD.,
`Petitioner
`
`
`
`v.
`
`
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.,
`Patent Owner
`
`
`
`CASE: IPR2014-00586
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT 8,278,351
`UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`Mail Stop “PATENT BOARD” Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`TABLE OF CONTENTS
`
`EXHIBIT LIST ......................................................................................................... ii
`
`INTRODUCTION ..................................................................................................... 1
`
`NOTICE OF EACH REAL PARTY IN INTEREST ................................................ 1
`
`NOTICE OF LEAD AND BACKUP COUNSEL ..................................................... 1
`
`NOTICE OF SERVICE INFORMATION ................................................................ 1
`
`NOTICE OF RELATED MATTERS ........................................................................ 2
`
`GROUNDS FOR STANDING .................................................................................. 3
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW ............... 3
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED .................................. 4
`
`I.
`
`II.
`
`THE ’351 PATENT ......................................................................................... 4
`
`PERSON OF SKILL IN THE ART AND STATE OF THE ART ................. 6
`
`III. CLAIM CONSTRUCTION ............................................................................ 9
`
`IV. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY ..................................................................................10
`
`Ground 1: Claims 47-52, 55, 58, 59, and 65-69 are Unpatentable
`under 35 U.S.C. § 102(b) Over Beaudoin I (Ex. 1002) .................................15
`
`Ground 2: Claims 47-52, 55, 58, 59, and 65-69 are Unpatentable
`Under 35 U.S.C. 103(a) over Fricke (Ex. 1006) in view of Bergelson
`(Ex. 1017), and further in view of Yasawa (Ex. 1015), Itano (Ex.
`1009), the WHO Bulletin (Ex. 1018) ............................................................21
`
`V.
`
`CONCLUSION ..............................................................................................27
`
`
`
`i
`
`
`
`
`
`
`
`EXHIBIT LIST
`
`ENZYMOTEC
`EXHIBIT
`1001
`
`DESCRIPTION
`U.S. Pat. No. 8,278,351 to Sampalis (“’351”)
`
`1002
`
`1003
`
`1004
`
`1005
`
`WO 00/23546 to Beaudoin (“Beaudoin I”)
`
`Canadian Application 2,251,265 to Beaudoin (“Beaudoin II”)
`
`Certified translation of Ex. 1070: Japanese Unexamined Patent
`
`Application Publication No. 02-215351, titled Krill
`
`Phospholipids Fractioning Method (“Maruyama,”); Certificate
`
`of Translation provided as Ex. 1071.
`
`Certified translation of Ex. 1072: Fisheries Agency, General
`
`Report on Research and Development of Techniques in
`
`Processing and Utilization of Marine Products, Chapter 6,
`
`Development of technology for recovery of valuable substances
`
`(astaxanthin) from krill, by Takao Fujita, pp. 273-307 (March
`
`1985) (“Fujita”) ; Certificate of Translation provided as Ex. 1073.
`
`Fricke et al., Lipid, Sterol, and Fatty Acid Composition of
`
`1006
`
`Antarctic Krill, Lipids, Vol. 19, No. 11, pp. 821-827 (1984)
`
`(“Fricke”)
`
`ii
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Bottino, N.R., “Lipid Composition of Two Species of
`
`1007
`
`1008
`
`Antarctic Krill: Euphausia Superba and E. Crystallorophias,”
`
`Comp. Biochem. Physiol., 1975, Vol. 50B, pp. 479-484
`
`(“Bottino”)
`
`Canadian Patent No. 1098900, titled Method for the Processing
`
`of Krill to Produce Protein, Lipids and Chitin (“Rogozhin”)
`
`Itano Refrigerated Food Co., Ltd., Bio & High Technology
`
`1009
`
`Announcement and Natural Astaxanthin & Krill Lecithin, pp. 1-
`
`1010
`
`1011
`
`1012
`
`16 (on or before December 28, 1994) (“Itano”)
`
`WO97/39759 to Stoll (“Stoll”)
`
`Final Prospectus dated May 11, 2001 (“Final Prospectus”)
`
`“Neptune Technologies & Bioressources Soon to Obtain a Major
`
`Patent in Over 30 Countries” (“2011 Press Release,”)
`
`Le Grandois et al., Investigation of Natural Phosphatidycholine
`
`Sources: Separation and Identification by Liquid
`
`1013
`
`Chromatography -Electrospray Ionization-Tandem Mass
`
`Spectrometry (LC-ESI- MS2) of Molecular Species, J. Agric.
`
`Food Chem., 57, 6014-20 (2009) (“Le Grandois”)
`
`iii
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Certified translation of Ex. 1074: Japanese Patent No. 60-
`
`1014
`
`153779, entitled “Nutritional Supplement” (“Fukuoka ”);
`
`Certificate of Translation provided as Ex. 1075
`
`Certified translation of Ex. 1076: Japanese Patent Publication
`
`No. H08-231391, entitled “Medicine for Improvement of
`
`Dementia Symptoms” (“Yasawa”); Certificate of Translation
`
`provided as Ex. 1077.
`
`Suzuki, T. and Shibata, N., “The utilization of Antarctic krill
`
`for human food,” Food Rev. Int’l, 6:1, 119-147 (1990)
`
`(“Suzuki”)
`
`Bergelson (ed.), Lipid Biochemical Preparations, Chapter I.1, pp.
`
`1-13 (1980) (“Bergelson”)
`
`WHO News and Activities, Bulletin of the World Health
`
`Organization, 73(4), pp. 547-51 (1995) (“WHO Bulletin”)
`
`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-
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`573 (1991) (“Bell and Dick”)
`
`iv
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Henderson et al., Lipid Composition of the Pineal Organ from
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`Rainbow Trout (Oncorhynchus mykiss), Lipids, Vol. 29, No.
`
`5, pp. 311-317 (1994) (“Henderson ”)
`
`Bell, Molecular Species Analysis of Phosphoglycerides from the
`
`Ripe Roes of Cod, Lipids, Vol. 24, No. 7 (1989)
`
`Takahashi et al., Compositional Changes in Molecular Species of
`
`Fish Muscle Phosphatidylcholine During Storage, Bull. Fac. Fish.
`
`Hokkaido Univ. 37(1), 80-84 1986.
`
`Takahashi et al., Prediction of Relative Retention Value of the
`
`Individual Molecular Species of Diacyl Glycerolipid on High
`
`Performance Liquid Chromatography, Bull. Fac. Fish.
`
`Hokkaido Univ. 38(4), 398-404. 1987
`
`Lin et al., Effect of Dietary N-3 Fatty Acids Upon the
`
`Phospholipid Molecular Species of the Monkey Retina,
`
`Invest Ophthalmol Vis Sci. 1994;35:794-803
`
`Farkas, Composition and Physical State of Phospholipids in
`
`Calanoid Copepods from India and Norway, LIPIDS, Vol. 23,
`
`No. 6 (1988)
`
`v
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Bell, Molecular Species Composition of Phosphatidylcholine
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`from Crypthecodinium cohnii in Relation to Growth Temperature
`
`Lipids 25, 115-118 (1990)
`
`Buda, Structural order of membranes and composition of
`
`phospholipids in fish brain cells during thermal
`
`acclimatization, Proc. Natl. Acad. Sci. USA Vol. 91, pp. 8234-
`
`8238, August 1994
`
`Takahashi et al., Molecular Species of Fish Muscle Lecithin,
`
`Bulletin of the Japanese Society of Scientific Fisheries
`
`48(12), 1803-1814 (1982)
`
`Tocher, Chapter 6, Glycerophospholipid metabolism,
`
`Biochemistry and molecular biology of fishes, vol. 4,
`
`Hochachka and Mommsen (eds.)(1995)
`
`Tanaka, Biosynthesis of 1,2-dieicosapentaenoyl-sn-glycero-3-
`
`phosphocholine in Caenorhabditis elegans, Eur. J. Biochem.
`
`263, 189-194 (1999)
`
`vi
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Winther et al., Elucidation of Phosphatidylcholine Composition
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`in Krill Oil Extracted from Euphausia superba, Lipids 46(1):25-
`
`36 (2011)(“Winther”)
`
`Eichberg, “Lecithin – It Manufacture and Use in the Fat and Oil
`
`Industry,” Oils and Soap 51-54, 1939 (“Eichberg”)
`
`Balassa et al., Microencapsulation in the Food Industry, Critical
`
`Reviews in Food Technology, 2:2, 245-265 (1971)(“Balassa”)
`
`Buchi R-220 Rotovapor® Manual
`
`Johnson and Lucas, Comparison of Alternative Solvents for Oils
`
`Extraction, JAOCS 60(2):229-242 (1983)
`
`U.S. Pat. No. 4,714,571
`
`Grit et al., Int. J. Pharmaceutics 50:1-6 (1989)
`
`Herman and Groves, Pharmaceutical Research 10(5):774-
`
`776 (1993)
`
`Watanabe et al., Effective Components in Cuttlefish Meal
`
`and Raw Krill for Improvement of Quality of Red Seabream
`
`Pagrus major Eggs, Nippon Suisan Gakkaishi 57(4):681-694
`
`(1991) (“Watanabe”)
`
`vii
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Declaration of Dr. Richard van Breemen in Support of Inter
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`Partes Review of U.S. Pat. No. 8,278,351 (“Van Breemen”)
`
`Declaration of Dr. Suzanne Budge in Support of Inter Partes
`
`Review of U.S. Pat. No. 8,278,351 (“Budge”)
`
`Declaration of Dr. Thomas Brenna in support of Inter Partes
`
`Review of U.S. Pat. No. 8,278,351
`
`Expert Witness Report of Dr. Theodore Welch submitted
`
`in relation to ITC Investigation No. 337-TA-877
`
`(“Welch”)
`
`Declaration of Dr. Jeff Moore in Support of Inter Partes Review
`
`of U.S. Pat. No. 8,278,351 (“Moore”)
`
`Declaration of Dr. Albert Lee in Support of Inter Partes Review
`
`of U.S. Pat. No. 8,278,351 (“Lee”)
`
`Declaration of Dr. Ivar Storrø in support of Inter Partes Review
`
`of U.S. Pat. No. 8,278,351 (“Storrø”)
`
`Declaration of Bjorn Ole Haugsgjerd submitted during inter
`
`partes reexamination of parent patent U.S. 8,030,348
`
`(“Haugsgjerd ’348 Decl.”)
`
`viii
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Supplemental Declaration of Bjorn Ole Haugsgjerd submitted
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`during inter partes reexamination of parent patent U.S.
`
`8,030,348 (“Haugsgjerd ’348 Supp. Decl.”)
`
`Declaration of Dr. Thomas Gundersen submitted during inter
`
`partes reexamination of parent patent U.S. 8,030,348
`
`(“Gundersen Decl.”)
`
`Supplemental Declaration of Dr. Thomas Gundersen submitted
`
`during inter partes reexamination of parent patent U.S.
`
`8,030,348 (“Gundersen Supp. Decl.”)
`
`Declaration of Dr. Earl White submitted during prosecution
`
`of parent patent U.S. 8,030,348 (“2011 White Decl.”)
`
`Supplemental Declaration of Dr. Earl White submitted during
`
`prosecution of parent patent U.S. 8,278,351 (“White Supp.
`
`Decl.”)
`
`Declaration of Dr. Jacek Jaczynski from inter partes
`
`reexamination of the parent patent U.S. 8,030,348 (“Jaczynski
`
`Reexam. Decl.”)
`
`ix
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Declaration of Dr. Yeboah submitted during inter partes
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`reexamination of parent patent U.S. 8,030,348 (“Yeboah
`
`Reexam Decl.”)
`
`Supplemental Declaration of Dr. Earl White submitted during
`
`inter partes reexamination of parent patent U.S. 8,030,348
`
`(“White Supp. Reexam. Decl.”)
`
`Declaration of Dr. Shahidi submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (Shahidi
`
`Reexam. Decl.”
`
`Declaration of Dr. Tina Sampalis submitted during inter
`
`partes reexamination of parent patent U.S. 8,030,348
`
`(Sampalis”)
`
`Declaration of Dr. Yeboah submitted during prosecution of
`
`parent patent U.S. 8,278,351 (“Yeboah ’351 Decl.”)
`
`Declaration of Dr. Shahidi submitted during prosecution of
`
`parent patent U.S. 8,278,351 (Shahidi ’351 Decl.”)
`
`Declaration of Dr. Jaczynski submitted during prosecution
`
`of parent patent U.S. 8,278,351 (Jaczynski ’351 Decl.”)
`
`x
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`1061
`
`DESCRIPTION
`April 2, 2012 Response to Office Action, ’351 patent
`
`Provisional Application No. 60/307,842 (Priority document for
`
`1062
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`the ’351 patent)
`
`Office Action dated January 5, 2012, ’351 patent
`
`Action Closing Prosecution, ’348 patent
`
`Grant of Request for Ex parte Reexamination of the ’351 patent
`
`Declaration of Dr. Van Breemen submitted during Ex parte
`
`Reexamination of the ‘351 patent (Van Breemen ’351
`
`Reexam. Decl.”
`
`Declaration of Dr. Van Breemen submitted during Inter
`
`partes Reexamination of the ‘348 patent (Van Breemen ’348
`
`Reexam Decl.”
`
`Medina et al., J. Amer. Oil Chem. Soc. 71(5):479-82 (1994)
`
`U.S. Patent No. 8,030,348
`
`Japanese Unexamined Patent Application Publication No. 02-
`
`215351, titled Krill Phospholipids Fractioning Method; Japanese
`
`language document
`
`xi
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Certification of translation of Ex. 1070: Japanese Unexamined
`
`1071
`
`Patent Application Publication No. 02-215351
`
`Fisheries Agency, General Report on Research and
`
`Development of Techniques in Processing and Utilization of
`
`Marine Products, Chapter 6, Development of technology for
`
`1072
`
`recovery of valuable substances (astaxanthin) from krill, by
`
`Takao Fujita, pp. 273-307 (March 1985); Japanese language
`
`document
`
`Certificate of translation of Ex. 1072: Fisheries Agency, General
`
`Report on Research and Development of Techniques in
`
`Processing and Utilization of Marine Products, Chapter 6,
`
`1073
`
`Development of technology for recovery of valuable substances
`
`(astaxanthin) from krill, by Takao Fujita, pp. 273-307 (March
`
`1985); Japanese language document
`
`Japanese Patent No. 60-153779, entitled “Nutritional
`
`Supplement”; Japanese language document
`
`Certificate of translation of Ex. 1074: Japanese Patent No. 60-
`
`153779, entitled “Nutritional Supplement”
`
`1074
`
`1075
`
`xii
`
`
`
`
`
`ENZYMOTEC
`EXHIBIT
`
`DESCRIPTION
`Japanese Patent Publication No. H08-231391, entitled
`
`1076
`
`1077
`
`1078
`
`1079
`
`1080
`
`“Medicine for Improvement of Dementia Symptoms”; Japanese
`
`language document
`
`Certificate of translation of Ex. 1076: Japanese Patent
`
`Publication No. H08-231391, entitled “Medicine for
`
`Improvement of Dementia Symptoms”
`
`Folch, et al., A Simple Method for the Isolation and Purification
`
`of Total Lipids from Animal Tissues. J. Biol. Chem., 226, 497-
`
`509 (1957)
`
`Declaration of Dr. Chong Lee submitted during inter partes
`
`reexamination of parent patent U.S. 8,030,348 (“Yeboah
`
`Reexam Decl.”)
`
`Declaration of Bjorn Ole Haugsgjerd in support of Inter Partes
`
`Review of U.S. Pat. No. 8,278,351 (“Haugsgjerd”)
`
`xiii
`
`
`
`
`
`INTRODUCTION
`
`In this Petition for Inter Partes Review, Petitioner Enzymotec Ltd. seeks
`
`cancellation of claims 47-52, 55, 58, 59, and 65-69 of U.S. Pat. 8,278,351 to
`
`Sampalis (the “’351 patent,” Ex. 1001). Concurrently filed herewith is a Power of
`
`Attorney pursuant to 37 C.F.R. § 42.10(b). The Office is authorized to charge fee
`
`deficiencies to Deposit Account 11-0600.
`
`NOTICE OF EACH REAL PARTY IN INTEREST
`
`Enzymotec Ltd. and Enzymotec USA, Inc. are the real parties in interest.
`
`NOTICE OF LEAD AND BACKUP COUNSEL
`
`Lead Counsel
`Elizabeth J. Holland
`(Reg. No. 47,657)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`eholland@kenyon.com
`Tel: 212-908-6307
`Fax: 212-425-5288
`
`Back-up Counsel
`Cynthia Lambert Hardman
`(Reg. No. 53,179)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`chardman@kenyon.com
`Tel: 212-908-6370
`Fax: 212-425-5288
`
`NOTICE OF SERVICE INFORMATION
`
`Please direct all correspondence to lead counsel at the contact information
`
`above. Petitioner consents to service by electronic mail at eholland@kenyon.com
`
`and chardman@kenyon.com.
`
`1
`
`
`
`
`
`NOTICE OF RELATED MATTERS
`
`The ’351 patent is the subject of an Inter Partes Review that was instituted
`
`on March 24, 2014 (IPR2014-00003); a Petition for Inter Partes Review
`
`(IPR2014-00556), filed on April 4, 2014; and a motion for joinder of Inter Partes
`
`Review IPR2014-00556 with IPR2014-00003 (filed on April 4, 2014 in IPR2014-
`
`00556). The ’351 patent is also asserted in: (1) Neptune Technologies and
`
`Bioressources, Inc. (“Neptune”) v. Aker BioMarine ASA et al. (“Aker”), D. Del.,
`
`1:12cv1252 (the parties filed a stipulation and proposed order of dismissal on April
`
`10, 2014); (2) Neptune v. Enzymotec Ltd. et al. (“Enzymotec”), D. Del.,
`
`1:12cv1253; and (3) Investigation No. 337-TA-887 in the U.S. International Trade
`
`Commission (the “ITC Investigation”). In addition, the ’351 patent is in Ex Parte
`
`Reexamination, Control No. 90/012,698, where all claims were rejected as
`
`anticipated and/or obvious over prior art in a non-final Office Action. The Ex
`
`Parte Reexamination has been stayed pending termination or completion of
`
`IPR2014-00003. (See IPR2014-00003 at Paper No. 25.)
`
`The ’351 patent is a continuation of U.S. Pat. 8,030,348 (the “’348 patent”;
`
`Ex. 1069). The ’348 patent is asserted in: (1) Neptune v. Aker, D. Del.,
`
`1:11cv894; and (2) Neptune v. Enzymotec Ltd. et al., D. Del., 1:11cv895. The
`
`’348 patent is also subject to an Inter Partes Reexamination (95/001,774). All
`
`claims currently stand rejected in an Action Closing Prosecution. (See Ex. 1064.)
`
`2
`
`
`
`
`
`U.S. Patent No. 8,383,675 (“the ’675 patent”) is a continuation of the ’351
`
`patent. The ’675 patent is asserted in: (1) Neptune v. Aker, D. Del., 1:13cv340
`
`(the parties filed a stipulation and proposed order of dismissal on April 10, 2014);
`
`(2) Neptune v. Enzymotec Ltd. et al., D. Del., 1:13cv341; and (3) the ITC
`
`Investigation. The ’675 patent is also the subject of a Petition for Inter Partes
`
`Review. (IPR2014-00466.)
`
`GROUNDS FOR STANDING
`
`Petitioner certifies that the ’351 patent is available for inter partes review
`
`and that Petitioner is not estopped from requesting an inter partes review
`
`challenging the patent claims on the grounds identified in this petition. In
`
`particular, as this Petition is accompanied by a timely Motion for Joinder under 37
`
`C.F.R. §§ 42.22 and 42.122(b), the one year time limitation prescribed by 35
`
`U.S.C. § 315(b) does not apply. (See 35 U.S.C. § 315(b) (“The time limitation set
`
`forth in the preceding sentence shall not apply to a request for joinder under
`
`subsection (c)).”)
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND
`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
`
`Petitioner requests inter partes review and cancellation of claims 47-52, 55,
`
`
`
`58, 59, and 65-69 of the ’351 patent based on one or more of the grounds under 35
`
`U.S.C. §§ 102 or 103 set forth herein. A petition for inter partes review must
`
`demonstrate “a reasonable likelihood that the petitioner would prevail with respect
`3
`
`
`
`
`
`to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The
`
`Petition meets this threshold. Petitioner’s detailed statement of the reasons for the
`
`relief requested is set forth below in the section “Statement of Reasons for Relief
`
`Requested.”
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`I.
`
`THE ’351 PATENT
`
`The ’351 patent issued on October 2, 2012. The ’351 patent was filed on
`
`July 25, 2011 and is a continuation of U.S. patent 8,030,348, which issued on
`
`October 4, 2011. The ’348 patent is a national phase entry of
`
`PCT/CA02/01185, filed July 29, 2002, which claims the benefit of U.S. Prov.
`
`Appl. 60/307,842, filed July 27, 2001 (Ex. 1062).
`
`It is well-established law that the effective priority date of claims depends
`
`on whether the claims are supported by the identified priority documents. See
`
`MPEP 2258; 35 U.S.C. § 120. The ’351 patent contains substantial disclosure
`
`that was not disclosed in Prov. Appl. 60/307,842, filed July 27, 2001 (Ex. 1062).
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`Independent claims 1, 24, 47, 70 and 94 of the ’351 patent are each directed to
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`specific phospholipids defined by the following chemical structure:
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`4
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`a phospholipid of the formula (I)
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`wherein R1 and R2,
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`each together with the respective carboxyl groups to which each is attached, each
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`independently represents a docosahexaenoic acid (DHA) or an eicosapentaenoic
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`acid (EPA) residue, and X is –CH2CH2NH3, –CH2CH2N(CH3)3,
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`. These phospholipids are referred to hereafter as the
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`or
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`“claimed phospholipids.”
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`Neither this structure nor specific phospholipid molecules defined by this
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`structure are described in Prov. Appl. 60/307,842. Thus, there is no written
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`description for the claimed phospholipids in Prov. Appl. 60/307,842 and the
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`claims of the ’351 patent are not entitled to the priority date of the provisional
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`application. Accordingly, the effective filing date of the claims of the ’351
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`patent is no earlier than the July 29, 2002 filing date of PCT/CA02/01185.
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`The Examiner issued a single office action dated January 5, 2012 during
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`the prosecution of the ’351 patent (Ex. 1063). The claims were rejected (1) on
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`the grounds of non-statutory obviousness-type double patenting as unpatentable
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`over claims 1-21 of the ’348 patent, (2) on the grounds of non-statutory
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`obviousness-type double patenting as unpatentable over claims 13-15 of at the
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`time co-pending 12/915,724 (now US 8,383,675), and (3) on the grounds of 35
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`5
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`U.S.C. §102(b) as being anticipated by Beaudoin I. Neptune responded and filed
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`a terminal disclaimer over the ’348 patent on April 2, 2012 to overcome the
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`double patenting rejection. In addition, Neptune replaced the pending claims
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`with new claims 121-216, and preemptively argued that such claims are not
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`anticipated by Beaudoin I.
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`In order to support its preemptive non-anticipation argument, Neptune
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`submitted Declarations by Dr. Earl White. (See Exs. 1051 and 1052; each
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`originally filed during prosecution of the ’348 patent). The White Declarations
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`purported to provide an analysis of krill oil produced by the process described
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`in Beaudoin I (Ex. 1002) and concluded the phospholipids obtained through the
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`Beaudoin I technique did not have EPA and EPA, DHA and EPA, or DHA and
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`DHA attached. (Ex. 1051 at ¶11.) Neptune further submitted Declarations
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`from Dr. Yeboah (Ex. 1058), Dr. Shahidi (Ex. 1059), and Dr. Jaczynski (Ex.
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`1060) (similar versions originally filed during reexamination of the ’348
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`patent).
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`The Examiner allowed the claims on June 1, 2012.
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`II.
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`PERSON OF SKILL IN THE ART AND STATE OF THE ART
`With respect to the ’351 patent, a POSA is a person with an advanced
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`degree in a field such as chemical engineering, food engineering, pharmacology,
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`6
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`analytical chemistry, biochemistry, organic chemistry, biology, marine biology,
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`or food chemistry, and at least (i) several years of experience in preparing lipid
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`extracts from biological or natural products, for example in an industrial or
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`research setting and/or (ii) several years of experience in analytical chemistry.
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`A person of ordinary skill in the art may consist of a team of individuals with the
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`foregoing education and experience. The more education one has, for example
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`post-graduate degrees and/or study, the less industry experience is needed to
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`attain an ordinary level of skill.
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`The structure of phospholipids was well known in the art as of July 27
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`2001. The generalized structure of a phospholipid molecule is as follows:
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`
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`
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`This structure depicts two fatty acid molecules attached to a glycerol backbone
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`along with a polar head group. The polar head group may, for example, be a
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`choline residue in phosphatidylcholine molecule or a serine residue in a
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`phosphatidylserine molecule. The ’351 patent claims designate that the fatty acids
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`are EPA or DHA:
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`. It is common in the art to refer to the positions
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`7
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`where the fatty acids are attached as the SN-1 and SN-2 positions:
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`
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`Despite admissions that the claimed phospholipids were known (see, e.g.,
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`Ex. 1001, Col. 2), Neptune repeatedly states in the ’351 specification that
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`phospholipids with EPA and DHA at both sn-1 and sn-2 positions of the
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`phospholipid are novel. This is incorrect. The claimed phospholipids were
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`described in numerous prior art publications and are not novel. (See, e.g., Exs.
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`1019, 1020, 1021, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029 and 1030.)
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`As of either July 27, 2001 or July 29, 2002, lipid extracts from krill with
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`a high phospholipid, EPA and DHA content were well known in the art. (See,
`
`e.g., Beaudoin I (Ex. 1002), Beaudoin II (Ex. 1003), Maruyama (Ex. 1004),
`
`Fujita (Ex. 1005), Fricke (Ex. 1006), Bottino (Ex. 1007), and Itano (Ex. 1009).)
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`Testing of repeats of the prior art by independent experts confirms that the
`
`claimed phospholipids were necessarily present in the Beaudoin I, Beaudoin II,
`
`Maruyama and Fujita extracts. (See, e.g., van Breemen (Ex. 1040), Budge (Ex.
`
`1041), Haugsgjerd (Ex. 1080), and Gundersen (Ex. 1050), discussed in detail
`
`below.)
`
`Methods for removal of solvent from extracts were well known in the art.
`
`(See, e.g., Bergelson (Ex. 1017, p.10-11).) Further, it was known in the art to
`
`8
`
`
`
`
`
`encapsulate omega-3 phospholipid compositions and krill extracts in capsules and
`
`to incorporate krill oil and phospholipids comprising a DHA and/or an EPA at
`
`both of the sn-1 and sn-2 positions of the phospholipids into tablets, capsules,
`
`syrups, solutions, etc. (See, e.g., Stoll (Ex. 1010, pp. 8-9); Fukuoka (Ex. 1014, p.
`
`363, col. 1-2); and Yasawa (Ex. 1015, ¶¶0008-17).) Krill oils are solutions as the
`
`various lipid components are dissolved in the oil (Brenna, Ex. 1042 at ¶ 202).
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`Thus, krill extracts and formulations suitable for human consumption were well
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`known in the art prior to July 27, 2001.
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`III. CLAIM CONSTRUCTION
`The claim terms in the ’351 patent are presumed to take on their ordinary
`
`and customary meaning based on the broadest reasonable interpretation of the
`
`claim language. With the exception of the term “about,” Petitioner does not
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`believe that the applicant, acting as its own lexicographer, attributed any special
`
`meanings to the claim terms in the ’351 patent when the broadest reasonable
`
`interpretation standard is applied.
`
`For example, when the broadest reasonable interpretation is applied:
`
`
`
`The term “krill extract” reads on any krill extract that comprises any
`
`amount of the claimed phospholipid. Although in the ’348 patent reexamination
`
`Patentee made statements disclaiming krill extracts produced by processes that
`
`involve heat, Patentee continues to assert that the claimed “krill extracts” are not
`
`9
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`
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`
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`limited to any particular process.
`
`
`
`The term “suitable for human consumption” reads on any form of
`
`consumption by a human (e.g., oral or topical administration) and places no limit
`
`on the amount that is consumed.
`
`
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`The term “about,” when used with a numerical value without further
`
`narrowing, is defined in the specification at col. 21, lines 61-63 as specifying that
`
`the value may vary by at least ± 50%.
`
`Petitioner’s position regarding the scope of the claims should not be taken as
`
`an assertion regarding the appropriate claim scope in other adjudicative forums
`
`where a different claim interpretation standard may apply.
`
`IV. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY
`
`IPR of the challenged claims of the ’351 patent is requested based on the
`
`two Grounds listed below. In support of the Grounds for Unpatentability, this
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`Petition is accompanied by Declarations of technical experts Drs. Van Breemen
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`(“Van Breemen” Ex. 1040), Brenna (“Brenna” Ex. 1042), Storrø (“Storrø” Ex.
`
`1046), Budge (“Budge” Ex. 1041), Welch (“Welch” Ex. 1043), Moore (“Moore”
`
`Ex. 1044), Lee (“Lee” Ex. 1045), Haugsgjerd (“Haugsgjerd” Ex. 1047, 1048,
`
`1080), and Gundersen (“Gundersen” Ex. 1049 and 1050). (Ex. 1043 was filed in
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`support of Petitioner in the ITC Investigation; Exs. 1047, 1048, 1049, and 1050
`
`were filed in support of the Inter Partes Reexamination of the ’348 patent.)
`10
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`
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`The challenged claims of the ’351 patent are directed toward krill extracts
`
`comprising phospholipid molecules with EPA or DHA at both sn-1 and sn-2
`
`positions on the phospholipid molecule (the “claimed phospholipids”). The claims
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`in the ’351 patent were allowed based on Neptune’s representations that certain of
`
`the claim limitations (such as the claimed phospholipids) were not recited
`
`explicitly in the prior art and were purportedly not inherently present. The simple
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`fact is this: there are numerous examples of krill extracts in the prior art that
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`necessarily contained the claimed phospholipids. The claimed phospholipids are
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`not novel. (See, e.g., Exs. 1019-30.) Petitioner’s extensive reproduction and
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`testing of the prior art extracts conclusively establishes that the prior art krill
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`extracts contained the claimed phospholipids and other extract components listed
`
`in the claims. (See, e.g., van Breemen (Ex. 1040), Budge (Ex. 1041), Haugsgjerd
`
`(Ex. 1080), and Gundersen (Ex. 1050), discussed in detail below.)
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`It is well established that “just as the discovery of properties of a known
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`material does not make it novel, the identification and characterization of a prior
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`art material also does not make it novel.” In re Crish, 393 F.3d 1253, 1258 (Fed.
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`Cir. 2004); see also In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir.
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`2002) (claims based on the patentee’s recognition that certain sprouts are rich in
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`compounds called glucosinolates not patentable). All Patentee has done here is
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`11
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`
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`identify phospholipid molecules that naturally occur in krill and all prior krill
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`extracts.
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`Furthermore, where the claimed and prior art products are identical or
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`substantially identical in structure or composition, or are produced by identical or
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`substantially identical processes, a prima facie case of either anticipation or
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`obviousness has been established. In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
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`That is certainly the case here where the processes described in the ’351 patent and
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`those described by the prior art are virtually indistinguishable. (See Storrø, Ex.
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`1046 at ¶7 and Brenna, Ex. 1042 at ¶63, which present a line-by-line comparison
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`of the ‘351 and the Beaudoin I and II methods.) The Board’s attention is
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`especially directed to the description of the processes in Beaudoin I, Ex. 1002, p. 5,
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`l. 21-p. 6, l. 20 and the ’351 patent, Ex. 1001, col. 18, l. 53- col. 19, l. 9. The
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`processes are virtually identical, as would be the resulting extracts.
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`Throughout the prosecution of the ’351 patent, the parent ’348 patent, and
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`the Inter Partes Reexamination of the ’348 patent, Neptune argued that the
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`phospholipids described in Beaudoin I were degraded when heat is applied during
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`solvent removal. What Neptune would have the Office believe is that every
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`naturally occurring phospholipid molecule in the Beaudoin I extracts that have
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`EPA and/or DHA at the sn-1 and sn-2 positions were degraded even though
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`Beaudoin I discloses extracts with a high phospholipid content. This argument is
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`12
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`not scientifically credible. Neptune has presented no experimental evidence
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`comparing heated and unheated samples or supporting its theory of degradation of
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`phospholipid molecules by heat. The failure of the references cited by Neptune to
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`support its position on phospholipid degradation is specifically addressed in Storrø.
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`(Ex. 1046 at ¶¶14-20.)
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`The only experimental evidence presented by Neptune purportedly showing
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`that the Beaudoin I extracts do not contain the claimed phospholipids is contained
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`in the White Declarations (Ex. 1051 and 1052). The Examiner relied on these
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`Declarations in allowing the claims. However, the White Declarations and the data
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`contained therein are fatally flawed. First, the evidence in the White Declarations
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`actually shows the presence of the claimed phospholipids in the Beaudoin I
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`extracts. Tables 1 and 2 of the 2011 White Declaration (Ex. 1051) demonstrate the
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`presence of phospholipids species at m/z 826.4 and 852.5 in fractions from each of
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`the sample sets tested. (Van Breemen, Ex. 1040 at ¶87.) These masses are
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`consistent with phosphatidylcholine containing EPA/EPA (m/z 826.4) and
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`EPA/DHA (m/z 852.5) being present in the samples. (Id.) Patentee’s experts, Dr.
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`Yeboah and Dr. Shahidi, both recognize this fact. (Yeboah Reexam. Decl., Ex.
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`1054 ¶36; Shahidi Reexam Dec., Ex. 1056 ¶22.) Second, Dr. White’s results do
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`not support the absence of the claimed phospholipids species in the Beaudoin I
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`13
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`extracts because he did not use positive controls. (Van Breemen, Ex. 1040 at
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`¶92.)
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`In contrast, the repeat data contained in the supporting Declarations
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`presented herewith by Petitioner conclusively establish that the claimed
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`phospholipids are necessarily present in the Beaudoin I (Ex. 1002) and Beaudoin II
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`(Ex. 1003) extracts. Dr. Budge (Ex. 1041) and Mr. Haugsgjerd (Ex. 1048)
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`repeated the Beaudoin I and II extraction protocols. Mr. Haugsgjerd’s extractions
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`specifically addressed criticisms of his initial repeats leveled
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