`
`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: IPR2014-00636
`
`
`
`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 ................. 7
`
`III. CLAIM CONSTRUCTION ............................................................................ 9
`
`IV. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY ..................................................................................11
`
`Ground 1: Claim 94 is Unpatentable under 35 U.S.C. § 102(b) Over
`Beaudoin I (Ex. 1002) ...................................................................................15
`
`Ground 2: Claim 94 is 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) and Itano (Ex. 1009) .........................................20
`
`V.
`
`CONCLUSION ..............................................................................................25
`
`
`
`
`
`
`
`
`
`
`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 Phosphatidylcholine
`
`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 claim 94 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 (1) an Inter Partes Review that was
`
`instituted on March 24, 2014 (IPR2014-00003); (2) a Petition for Inter Partes
`
`Review (IPR2014-00556), filed on April 4, 2014; (3) a motion for joinder of Inter
`
`Partes Review IPR2014-00556 with IPR2014-00003 (filed on April 4, 2014 in
`
`IPR2014-00556); (4) a Petition for Inter Partes Review (IPR2014-00586), filed on
`
`April 11, 2014; and (5) a motion for joinder of Inter Partes Review IPR2014-
`
`00586 with IPR2014-00003 (filed on April 11, 2014 in IPR2014-00586).
`
`The ’351 patent is also currently asserted in: (1) Neptune Technologies and
`
`Bioressources, Inc. (“Neptune”) v. Enzymotec Ltd. (“Enzymotec”) et al., D. Del.,
`
`1:12cv1253; and (2) 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 (currently stayed), 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 currently asserted in: (1) Neptune v. Aker
`
`BioMarine ASA et al. (“Aker”), D. Del., 1:11cv894; and (2) Neptune v.
`
`Enzymotec et al., D. Del., 1:11cv895. The ’348 patent is also subject to an Inter
`
`
`
`
`2
`
`
`
`
`
`
`Partes Reexamination (95/001,774). Per a USPTO communication and Right of
`
`Appeal Notice mailed April 18, 2014, all claims stand rejected in a final decision.
`
`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. Enzymotec et al., D. Del.,
`
`1:13cv341; and (2) 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 claim 94 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 to at least 1 of the claims
`3
`
`
`
`
`
`
`
`
`
`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).
`
`Independent claims 1, 24, 47, 70 and 94 of the ’351 patent are each directed to
`
`specific phospholipids defined by the following chemical structure:
`
`
`
`4
`
`
`
`
`
`
`
`
`a phospholipid of the formula (I)
`
`wherein R1 and R2,
`
`each together with the respective carboxyl groups to which each is attached, each
`
`independently represents a docosahexaenoic acid (DHA) or an eicosapentaenoic
`
`acid (EPA) residue, and X is –CH2CH2NH3, –CH2CH2N(CH3)3,
`
`or
`
`. These phospholipids are referred to hereafter as the
`
`“claimed phospholipids.”
`
`Neither this structure nor specific phospholipid molecules defined by this
`
`structure are described in Prov. Appl. 60/307,842. Thus, there is no written
`
`description for the claimed phospholipids in Prov. Appl. 60/307,842 and the
`
`claims of the ’351 patent are not entitled to the priority date of the provisional
`
`application. Accordingly, the effective filing date of the claims of the ’351
`
`patent is no earlier than the July 29, 2002 filing date of PCT/CA02/01185.
`
`The Examiner issued a single office action dated January 5, 2012 during
`
`the prosecution of the ’351 patent (Ex. 1063). The claims were rejected (1) on
`
`the grounds of non-statutory obviousness-type double patenting as unpatentable
`
`over claims 1-21 of the ’348 patent, (2) on the grounds of non-statutory
`
`5
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`obviousness-type double patenting as unpatentable over claims 13-15 of at the
`
`time co-pending 12/915,724 (now US 8,383,675), and (3) on the grounds of 35
`
`U.S.C. §102(b) as being anticipated by Beaudoin I. Neptune responded and filed
`
`a terminal disclaimer over the ’348 patent on April 2, 2012 to overcome the
`
`double patenting rejection. In addition, Neptune replaced the pending claims
`
`with new claims 121-216, and preemptively argued that such claims are not
`
`anticipated by Beaudoin I.
`
`In order to support its preemptive non-anticipation argument, Neptune
`
`submitted Declarations by Dr. Earl White. (See Exs. 1051 and 1052; each
`
`originally filed during prosecution of the ’348 patent). The White Declarations
`
`purported to provide an analysis of krill oil produced by the process described
`
`in Beaudoin I (Ex. 1002) and concluded the phospholipids obtained through the
`
`Beaudoin I technique did not have EPA and EPA, DHA and EPA, or DHA and
`
`DHA attached. (Ex. 1051 at ¶11.) Neptune further submitted Declarations
`
`from Dr. Yeboah (Ex. 1058), Dr. Shahidi (Ex. 1059), and Dr. Jaczynski (Ex.
`
`1060) (similar versions originally filed during reexamination of the ’348
`
`patent).
`
`The Examiner allowed the claims on June 1, 2012.
`
`6
`
`
`
`
`
`
`
`
`
`
`II.
`
`
`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
`
`degree in a field such as chemical engineering, food engineering, pharmacology,
`
`analytical chemistry, biochemistry, organic chemistry, biology, marine biology,
`
`or food chemistry, and at least (i) several years of experience in preparing lipid
`
`extracts from biological or natural products, for example in an industrial or
`
`research setting and/or (ii) several years of experience in analytical chemistry.
`
`A person of ordinary skill in the art may consist of a team of individuals with the
`
`foregoing education and experience. The more education one has, for example
`
`post-graduate degrees and/or study, the less industry experience is needed to
`
`attain an ordinary level of skill.
`
`The structure of phospholipids was well known in the art as of July 27
`
`2001. The generalized structure of a phospholipid molecule is as follows:
`
`
`
`
`
`This structure depicts two fatty acid molecules attached to a glycerol backbone
`
`along with a polar head group. The polar head group may, for example, be a
`
`choline residue in phosphatidylcholine molecule or a serine residue in a
`
`phosphatidylserine molecule. The ’351 patent claims designate that the fatty acids
`
`
`
`
`7
`
`
`
`
`
`are EPA or DHA:
`
`. It is common in the art to refer to the positions
`
`where the fatty acids are attached as the SN-1 and SN-2 positions:
`
`
`
`Despite admissions that the claimed phospholipids were known (see, e.g.,
`
`Ex. 1001, Col. 2), Neptune repeatedly states in the ’351 specification that
`
`phospholipids with EPA and DHA at both sn-1 and sn-2 positions of the
`
`phospholipid are novel. This is incorrect. The claimed phospholipids were
`
`described in numerous prior art publications and are not novel. (See, e.g., Exs.
`
`1019, 1020, 1021, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029 and 1030.)
`
`As of either July 27, 2001 or July 29, 2002, lipid extracts from krill with
`
`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).)
`
`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.)
`
`8
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`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).
`
`Thus, krill extracts and formulations suitable for human consumption were well
`
`known in the art prior to July 27, 2001.
`
`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. Petitioner does not 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 “Antarctic krill oil extract” reads on any krill extract that
`
`comprises any amount of the claimed phospholipid. There is no element in the
`
`claim that distinguishes Antarctic krill extracts from any other krill extract.
`
`
`
`
`9
`
`
`
`
`
`
`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 “Antarctic krill oil extracts” are not 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.
`
`
`
`The phrase “extracted under conditions suitable for preserving an
`
`effective amount of a phospholipid . . .” appears to read on methods that preserve
`
`an amount effective for any purpose contemplated in the specification and does not
`
`limit the scope of the claims (and/or is indefinite), as the specification does not
`
`disclose what constitutes an effective amount, or any particular process or
`
`technique for obtaining an “effective amount.” Petitioner further notes that at best
`
`this is a process limitation that should not be given no weight when determining
`
`the patentability of a composition claim.
`
`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.
`
`
`
`
`10
`
`
`
`
`
`
`IV. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY
`
`IPR of claim 94 of the ’351 patent is requested based on the two Grounds
`
`listed below. In support of the Grounds for Unpatentability, this Petition is
`
`accompanied by Declarations of technical experts Drs. Van Breemen (“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 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.)
`
`Claim 94 of the ’351 patent is directed towards 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 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 fact is this: there
`
`are numerous examples of krill extracts in the prior art that necessarily contained
`
`the claimed phospholipids. The claimed phospholipids are not novel. (See, e.g.,
`
`Exs. 1019-30.) Petitioner’s extensive reproduction and testing of the prior art
`
`extracts conclusively establishes that the prior art krill extracts contained the
`11
`
`
`
`
`
`
`
`
`
`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.)
`
`It is well established that “just 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); see also In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir.
`
`2002) (claims based on the patentee’s recognition that certain sprouts are rich in
`
`compounds called glucosinolates not patentable). All Patentee has done here is
`
`identify phospholipid molecules that naturally occur in krill and all prior krill
`
`extracts.
`
`Furthermore, where the claimed and prior art products are identical or
`
`substantially identical in structure or composition, or are produced by identical or
`
`substantially identical processes, a prima facie case of either anticipation or
`
`obviousness has been established. In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
`
`That is certainly the case here where the processes described in the ’351 patent and
`
`those described by the prior art are virtually indistinguishable. (See Storrø, Ex.
`
`1046 at ¶7 and Brenna, Ex. 1042 at ¶63, which present a line-by-line comparison
`
`of the ‘351 and the Beaudoin I and II methods.) The Board’s attention is
`
`especially directed to the description of the processes in Beaudoin I, Ex. 1002, p. 5,
`
`
`
`
`12
`
`
`
`
`
`
`l. 21-p. 6, l. 20 and the ’351 patent, Ex. 1001, col. 18, l. 53- col. 19, l. 9. The
`
`processes are virtually identical, as would be the resulting extracts.
`
`Throughout the prosecution of the ’351 patent, the parent ’348 patent, and
`
`the Inter Partes Reexamination of the ’348 patent, Neptune argued that the
`
`phospholipids described in Beaudoin I were degraded when heat is applied during
`
`solvent removal. What Neptune would have the Office believe is that every
`
`naturally occurring phospholipid molecule in the Beaudoin I extracts that have
`
`EPA and/or DHA at the sn-1 and sn-2 positions were degraded even though
`
`Beaudoin I discloses extracts with a high phospholipid content. This argument is
`
`not scientifically credible. Neptune has presented no experimental evidence
`
`comparing heated and unheated samples or supporting its theory of degradation of
`
`phospholipid molecules by heat. The failure of the references cited by Neptune to
`
`support its position on phospholipid degradation is specifically addressed in Storrø.
`
`(Ex. 1046 at ¶¶14-20.)
`
`The only experimental evidence presented by Neptune purportedly showing
`
`that the Beaudoin I extracts do not contain the claimed phospholipids is contained
`
`in the White Declarations (Ex. 1051 and 1052). The Examiner relied on these
`
`Declarations in allowing the claims. However, the White Declarations and the data
`
`contained therein are fatally flawed. First, the evidence in the White Declarations
`
`actually shows the presence of the claimed phospholipids in the Beaudoin I
`
`
`
`
`13
`
`
`
`
`
`
`extracts. Tables 1 and 2 of the 2011 White Declaration (Ex. 1051) demonstrate the
`
`presence of phospholipids species at m/z 826.4 and 852.5 in fractions from each of
`
`the sample sets tested. (Van Breemen, Ex. 1040 at ¶87.) These masses are
`
`consistent with phosphatidylcholine containing EPA/EPA (m/z 826.4) and
`
`EPA/DHA (m/z 852.5) being present in the samples. (Id.) Patentee’s experts, Dr.
`
`Yeboah and Dr. Shahidi, both recognize this fact. (Yeboah Reexam. Decl., Ex.
`
`1054 ¶36; Shahidi Reexam Dec., Ex. 1056 ¶22.) Second, Dr. White’s results d
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
