Attorney Docket No. AKBM-33544
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`AKER BIOMARINE AS
`Petitioner
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`v.
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`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`
`CASE IPR: Unassigned
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,278,351
`UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Attorney Docket No. AKBM-33544
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`TABLE OF CONTENTS
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`
`INTRODUCTION .......................................................................................................................... 1 
`
`NOTICE OF LEAD AND BACKUP COUNSEL .......................................................................... 1 
`
`NOTICE OF EACH REAL PARTY IN INTEREST ..................................................................... 1 
`
`NOTICE OF RELATED MATTERS ............................................................................................. 1 
`
`NOTICE OF SERVICE INFORMATION ..................................................................................... 2 
`
`GROUNDS FOR STANDING ....................................................................................................... 2 
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................................................... 2 
`
`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW ............................................. 3 
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................................................ 3 
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`I.  THE ‘351 PATENT ............................................................................................................ 3 
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`II.  PERSON OF SKILL IN THE ART AND STATE OF THE ART ..................................... 6 
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`III.  CLAIM CONSTRUCTION ................................................................................................ 8 
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`IV.  CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR UNPATENTABILITY .. 10 
`
`Ground 1: Claims 1-94 are unpatentable under 35 U.S.C. 102(b) over Beaudoin I (Ex.
`1002). .................................................................................................................................... 15 
`
`Ground 2: Claims 1-94 are unpatentable under 35 U.S.C. 102(b) over Beaudoin II (Ex.
`1003) ..................................................................................................................................... 22 
`
`Ground 3: Claims 1-13, 19-36, 42-59, 65-83, and 89-94 are unpatentable under 35 U.S.C.
`102(b) over Maruyama (Ex. 1004) ....................................................................................... 28 
`
`Ground 4: Claims 1-6, 9, 12-14, 19-29, 32, 35-37, 42-52, 55, 58-60, 65-76, 79, 82-84, and
`89-94 are unpatentable under 35 U.S.C. 102(b) over Fujita (Ex. 1005) ............................... 33 
`
`Ground 5: Claims 1-6, 9, 19-29, 32, 42-52, 55, 65-76, 79, and 89-94 are unpatentable under
`35 U.S.C. 102(b) over Fricke (Ex. 1006) .............................................................................. 39 
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`Attorney Docket No. AKBM-33544
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`Ground 6: Claims 1, 19-21, 24, 42-44, 47 and 65-67 are unpatentable under 35 U.S.C.
`102(b) over Rogozhin (Ex. 1008) ......................................................................................... 44 
`
`Ground 7: Claims 1-94 are unpatentable under 35 USC 103(a) over Beaudoin I in view of
`Bergelson (Ex. 1017) ............................................................................................................ 46 
`
`Ground 8: Claims 1-94 are unpatentable under 35 USC 103(a) over Beaudoin I (Ex. 1002)
`in view of the Final Prospectus (Ex. 1011), 2001 Press Release (Ex. 1012) and Bergelson
`(Ex. 1017) ............................................................................................................................. 50 
`
`Ground 9: Claims 1-94 are unpatentable under 35 USC 103(a) over Fujita (Ex. 1005) in
`view of Watanabe (Ex. 1039), and further in view of Itano (Ex. 1009) and Yasawa (Ex.
`1015) ..................................................................................................................................... 54 
`
`Ground 10: Claims 1-94 are unpatentable under 35 USC 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) ............................................................................................... 57 
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`V.  CONCLUSION ..................................................................................................................... 60 
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`Attorney Docket No. AKBM-33544
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`INTRODUCTION
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`Aker Biomarine AS’s (“Petitioner”) Petition for Inter Partes Review
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`(“Petition”) seeks cancellation of claims 1-94 (“challenged claims”) of U.S. Pat.
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`No. 8,278,351 to Sampalis titled “Natural Marine Source Phospholipids
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`Comprising Polyunsaturated Fatty Acids and Their Applications” (the ‘351
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`patent)(Exhibit (“Ex.”) 1001)). Concurrently filed herewith are a Power of
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`Attorney and Exhibit List pursuant to § 42.10(b) and § 42.63(e), respectively. The
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`Office is authorized to charge fee deficiencies to Deposit Account 50-4302.
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`NOTICE OF LEAD AND BACKUP COUNSEL
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`Lead Counsel
`J. Mitchell Jones
`jmjones@casimirjones.com
`Hand delivery address:
`CASIMIR JONES SC
`2275 Deming Way, St. 310
`Middleton, WI 53562
`Telephone: (608) 662-1277
`Facsimile: (608) 662-1276
`Reg. No. 44,174
`
`
`Back-up Counsel
`Amanda Hollis
`amanda.hollis@kirkland.com
`Hand delivery address:
`KIRKLAND & ELLIS
`300 North LaSalle
`Chicago, IL 60654
`Telephone: 312-862-2011
`Facsimile: 312-862-2200
`Reg. No. 55,629
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`NOTICE OF EACH REAL PARTY IN INTEREST
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`Aker Biomarine AS, Fjordallèen 16, P.O. Box 1423 Vika, Oslo Norway
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`0115 is the real party in interest for Petitioners. Aker Biomarine AS is a wholly
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`owned subsidiary of Aker ASA.
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`NOTICE OF RELATED MATTERS
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`1
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`Attorney Docket No. AKBM-33544
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`The ‘351 patent is the subject of a patent infringement lawsuit filed on
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`October 1, 2012 in the United States District Court of Delaware (C.A. No. 12-
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`1252-GMS) and International Trade Commission (ITC) action Investigation No.
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`337-TA-877. The ‘351 patent is also the subject of an Ex Parte Reexamination,
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`Control No. 90/012,698, the request for which has been granted. See Ex. 1065.
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`The ‘351 patent is a continuation of U.S. Pat. 8,030,348 (the “’348 patent”; Ex.
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`1069), which is currently subject to an Inter Partes Reexamination with the control
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`number 95/001,774. All claims are currently rejected in the Action Closing
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`Prosecution. (See Ex. 1064.) The ‘348 patent is also the subject a patent
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`infringement lawsuit filed by Neptune Bioressources & Technologies against Aker
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`Biomarine in the United States District Court of Delaware (1:11-cv-00894-GMS).
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`NOTICE OF SERVICE INFORMATION
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`Please address all correspondence to lead counsel at the address shown
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`above. Petitioner also consents to electronic service by email to:
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`docketing@casimirjones.com.
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`GROUNDS FOR STANDING
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`Petitioner certifies that the ‘351 patent is available for inter partes review
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`and that Petitioner is not barred or estopped from requesting an inter partes review
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`challenging the patent claims on the Grounds identified in this petition.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Attorney Docket No. AKBM-33544
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`Petitioner requests inter partes review and cancellation of claims 1-94 of the
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`’351 patent based on one or more of the grounds under 35 U.S.C. §102 or 103 set
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`forth herein. Petitioner’s detailed statement of the reasons for the relief requested is
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`set forth below in the section “Statement of Reasons for Relief Requested.”
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`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
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`A petition for inter partes review must demonstrate "a reasonable likelihood
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`that the petitioner would prevail with respect to at least 1 of the claims challenged
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`in the petition." 35 U.S.C. § 314(a). The Petition meets this threshold. Each of
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`the elements of claims 1-94 of the ’351 patent are taught in the prior art as
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`explained below in the proposed Grounds for Unpatentability. Additionally, for
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`those Grounds under 35 U.S.C. § 103(a), the motivation to combine is provided.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED
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`I.
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`THE ‘351 PATENT
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`The ‘351 patent issued on October 2, 2012. The ‘351 patent was filed on
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`July 25, 2011 and is a continuation of U.S. patent 8,030,348, which issued on
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`October 4, 2011. The ‘348 patent is a national phase entry of PCT/CA02/01185,
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`filed July 27, 2002, which claims the benefit of U.S. Prov. Appl. 60/307,842, filed
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`July 27, 2001 (Ex. 1062).
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`
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`It is well-established law that the effective priority date of claims depends on
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`whether the claims are supported by the identified priority documents. See MPEP
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`Attorney Docket No. AKBM-33544
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`2258. The ‘351 patent contains substantial disclosure that was not disclosed in
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`Prov. Appl. 60/307,842, filed July 27, 2001 (Ex. 1062). Independent Claims 1, 24,
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`47, 70 and 94 of the ‘351 patent are each directed to specific phospholipids defined
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`by the following chemical structure:
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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,
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`each independently represents a docosahexaenoic acid (DHA) or an
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`eicosapentaenoic acid (EPA) residue, and X is –CH2CH2NH3, -CH2CH2N(CH3)3,
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`or
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`. These phospholipids are referred to hereafter as the “claimed
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`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 claims
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`of the ‘351 patent are not entitled to the priority date of the provisional application.
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`Accordingly, the effective filing date of the claims of the ‘351 patent is no earlier
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`than the July 27, 2002 filing date of PCT/CA02/01185.
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`Attorney Docket No. AKBM-33544
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`The Examiner issued a single office action dated January 5, 2012 during the
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`prosecution of the ‘351 patent (Ex. 1063). The claims were rejected 1) on the
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`grounds of non-statutory obviousness-type double patenting as unpatentable over
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`claims 1-21 of the ‘348 patent, 2) on the grounds of non-statutory obviousness-type
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`double patenting as unpatentable over claims 13-15 of at the time co-pending
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`12/915,724 (now US 8,383,675), and 3) on the grounds of 35 U.S.C. §102(b) as
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`being anticipated by Beaudoin I. Neptune responded and filed terminal
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`disclaimers April 2, 2012 to overcome the double patenting rejections. In addition,
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`Neptune replaced the pending claims with new claims 121-216, and preemptively
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`argued that such claims are not 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
`
`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 in
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`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, ¶11. Neptune further submitted Declarations from Dr.
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`Yeboah (Ex. 1058), Dr. Shahidi (Ex. 1059), and Dr. Jaczynski (Ex. 1060) (similar
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`versions originally filed during reexamination of the ‘348 patent).
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`The Examiner allowed the claims on June 1, 2012.
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`Attorney Docket No. AKBM-33544
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`II.
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`PERSON OF SKILL IN THE ART AND STATE OF THE ART
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`With respect to the ‘351 patent, a POSA is a person with an advanced degree
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`in a field such as chemical engineering, food engineering, pharmacology,
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`analytical chemistry, biochemistry, organic chemistry, biology, marine biology, or
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`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. A
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`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 attain
`
`an ordinary level of skill.
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`The structure of phospholipids was well known in the art as of July 27 2001.
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`The generalized structure of a phospholipid molecule is as follows:
`
`.
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`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
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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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`Attorney Docket No. AKBM-33544
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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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`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.,
`
`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
`
`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.
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`As of either July 27, 2001 or 2002, lipid extracts from krill with a high
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`phospholipid, EPA and DHA content were well known in the art. See, e.g.,
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`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
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`repeats of the prior art by independent experts confirms that the claimed
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`phospholipids were necessarily present in the Beaudoin I, Beaudoin II, Maruyama
`
`and Fujita extracts. See, e.g., van Breemen (Ex. 1040), Budge (Ex. 1041),
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`Haugsgjerd (Ex. 1080), and Gundersen (Ex. 1050), discussed in detail below.
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`Attorney Docket No. AKBM-33544
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`Methods for removal of solvent from extracts were well known in the art.
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`See, e.g., Bergelson (Ex. 1017, p.10-11.). Further, it was known in the art to
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`encapsulate omega-3 phospholipid compositions and krill extracts in capsules and
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`to incorporate krill oil and phospholipids comprising a DHA and/or an EPA at both
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`of the sn-1 and sn-2 positions of the phospholipids into tablets, capsules, syrups,
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`solutions, etc. Stoll (Ex. 1010, pp. 8-9); Fukuoka (Ex. 1014, p. 363, col. 1-2); and
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`Yasawa (Ex. 1015, ¶¶0008-17). Krill oils are solutions as the various lipid
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`components are dissolved in the oil. Brenna, Ex. 1042, ¶ 202. Thus, krill extracts
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`and formulations suitable for human consumption were well known in the art prior
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`to July 27, 2001.
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`III. CLAIM CONSTRUCTION
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`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
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`claim language. With the exception of “about,” Petitioner does not believe that the
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`applicant, acting as its own lexicographer, attributed any special meanings to the
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`claim terms in the ‘351 patent when the appropriate standard of broadest
`
`reasonable interpretation is applied.
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`For example, when the broadest reasonable interpretation is applied:
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` The terms “Krill extract” and “Antarctic krill extract” read on any
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`krill extract containing any amount of the claimed phospholipids.
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`Attorney Docket No. AKBM-33544
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`There is no element in the claims that distinguishes Antarctic krill
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`extracts from any other krill extract. Patentee has made statements
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`disclaiming krill extracts produced by processes that involve heat;
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`however Patentee still maintains “krill extract” and “Antarctic krill
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`extract” are not limited to any particular process.
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` The claims read on extracts that contain any amount of the claimed
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`phospholipids.
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` The term “suitable for human consumption” reads on any form of
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`consumption by a human (e.g., oral or topical administration) and
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`places no limit on the amount that is consumed.
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` The term “solution” reads on any solution (such as a krill oil)
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`containing the claimed phospholipid molecules including lipid
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`extracts in which the phospholipids are dissolved.
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` The term “food” reads on any substance (such as a krill oil) consisting
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`of nutrients such as proteins, carbohydrates, and fats and used in the
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`body of an organism to sustain growth, repair, and vital processes and
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`to furnish energy.
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` The term “cosmetic” reads on any substance that can be applied
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`externally to a subject, e.g., to the skin, nails, hair, etc., and can
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`include oils such as krill oil.
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`9
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`Attorney Docket No. AKBM-33544
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` The phrase “extracted under conditions suitable for preserving an
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`effective amount of a phospholipid . . .” reads on methods that
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`preserve an amount effective for any purpose contemplated in the
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`specification and does not limit the scope of the claims (and/or is
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`indefinite) as the specification does not disclose what constitutes an
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`effective amount.
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`The term “about” is defined in the specification at col. 21, line 61-63 as
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`specifying that when used with a numerical value, the value may vary by at least
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`+/- 50%.
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`Petitioner’s position regarding the scope of the claims should not be taken as
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`an assertion regarding the appropriate claim scope in other adjudicative forums
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`where a different claim interpretation standard may apply.
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`IV. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY
`
`
`
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`IPR of claims 1-94 of the ‘351 patent is requested based on the ten Grounds
`
`listed below. In support of the Grounds for Unpatentability, this Petition is
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`accompanied by Declarations of technical experts Drs. Van Breemen (“Van
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`Breemen” Ex. 1040), Brenna (“Brenna” Ex. 1042) Storrø (“Storrø” Ex. 1044),
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`Budge (“Budge” Ex. 1041); Welch (“Welch” Ex. 1043); Moore (“Moore” Ex.
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`1044), Lee (“Lee” Ex. 1045), Haugsgjerd (“Haugsgjerd” Ex. 1047, 1048, 1080)
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`Attorney Docket No. AKBM-33544
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`and Gundersen (“Gundersen” Ex. 1049 and 1050, filed in support of the Inter
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`Partes Reexamination of the ‘348 patent).
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`Claims 1-94 of the ‘351 patent are directed toward krill extracts comprising
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`phospholipid molecules with EPA or DHA at both sn-1 and sn-2 positions on the
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`phospholipid molecule (the “claimed phospholipids”). The claims in the ‘351
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`patent were allowed based on Neptune’s representations that certain of the claim
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`limitations (such as the claimed phospholipids) were not recited explicitly in the
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`prior art and were purportedly not inherently present. The simple fact is this: there
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`are numerous examples of krill extracts in the prior art that necessarily contained
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`the claimed phospholipids. The claimed phospholipids are not novel. (See, e.g.,
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`Exs. 1019-30, supra.) Petitioner’s extensive reproduction and testing of the prior
`
`art extracts conclusively establishes that the prior art krill extracts contained the
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`claimed phospholipids and other extract components listed in the claims. See, e.g.,
`
`van Breemen (Ex. 1040), Budge (Ex. 1041), Haugsgjerd (Ex. 1080), and
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`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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`Attorney Docket No. AKBM-33544
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`compounds called glucosinolates not patentable). All Patentee has done here is
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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, ¶ 7 and Brenna, Ex. 1042, ¶ 63, which present a line-by-line comparison of
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`the ‘351 and the Beaudoin I and II methods.) The Board’s attention is especially
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`directed to the description of the processes in Beaudoin I, Ex. 1002, p. 5, l. 21-p.
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`6, l. 20 and the ‘351 patent, Ex. 1001, col. 18, l. 53- col. 19, l. 9. The processes are
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`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
`
`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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`Attorney Docket No. AKBM-33544
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`Beaudoin I discloses extracts with a high phospholipid content. This argument is
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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, ¶¶ 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, ¶87. These masses are consistent
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`with phosphatidylcholine containing EPA/EPA (m/z 826.4) and EPA/DHA (m/z
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`852.5) being present in the samples. Id. Patentee’s experts, Dr. Yeboah and Dr.
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`Shahidi, both recognize this fact. Yeboah Reexam. Decl., Ex. 1054 ¶36; Shahidi
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`Reexam Dec., Ex. 1056 ¶22. Second, Dr. White’s results do not support the
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`Attorney Docket No. AKBM-33544
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`absence of the claimed phospholipids species in the Beaudoin I extracts because he
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`did not use positive controls. Van Breemen, Ex. 1040, ¶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 by Dr. Jaczynski
`
`during the co-pending reexamination of the ‘348 patent. (Ex. 1048, ¶¶2-5.) Dr.
`
`van Breemen analyzed the samples by mass spectrometry. Dr. van Breemen’s
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`mass spectrometry analysis shows that the Beaudoin I extracts contained the
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`claimed phospholipids (e.g., PC-EPA/EPA, PC-DHA/DHA, PC-DHA/EPA). (Ex.
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`1040, ¶¶73-85 and ¶¶93-98.) The results of the testing further establish that
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`heating had no effect on the presence of the claimed phospholipids in the extracts
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`as unheated, 60C heated and 125C heated extracts all contained the claimed
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`phospholipids. (Id. ¶¶48.)
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`Thus, the Examiner of the ‘351 patent erred by failing to recognize that the
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`claimed phospholipids are common, naturally occurring molecules necessarily
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`present in krill and prior art krill extracts. Moreover, the Examiner of the ‘351
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`patent did not have the benefit of the data in the Haugsgjerd, Van Breemen and
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`Attorney Docket No. AKBM-33544
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`Storrø Declarations submitted in the reexamination of the ‘348 patent because
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`Patentee and its attorneys did not disclose those declarations and the data contained
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`therein to the USPTO. Finally, the Examiner relied on the 2011 White Declaration
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`which erroneously represented that Beaudoin I repeats did not contain the claimed
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`phospholipids when in fact Tables 1 and 2 of that declaration demonstrate the
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`presence of the claimed phospholipids.
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` The following analysis for each Ground for Unpatentability identifies the art
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`and evidence relied upon by exhibit number and identifies the specific portions
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`relied upon for both anticipation and obviousness. For each Ground, the
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`independent claims are addressed first. The limitations in the dependent claims are
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`then addressed. With the exception of dependent claim 71, the dependent claims
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`for each of the first four independent claims contain identical limitations. See, van
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`Breemen, Ex.1040 ¶33. Thus, the dependent claims for the first four independent
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`claims are presented in groups for the claim-by-claim analysis.
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`Ground 1: Claims 1-94 are unpatentable under 35 U.S.C. 102(b) over
`Beaudoin I (Ex. 1002).
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`Beaudoin I published on April 27, 2000, more than one year before the
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`earliest filing date (July 27, 2001) of the ‘351 patent. Beaudoin I qualifies as prior
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`art under 35 U.S.C. §§ 102(b) and 103(a). Additional supporting evidence is
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`provided by van Breemen (Ex. 1040), Budge (Ex. 1041), Brenna (Ex. 1042), Lee
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`Attorney Docket No. AKBM-33544
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`(Ex. 1045), Moore (Ex. 1044), Storrø (Ex. 1046), and Haugsgjerd (Ex. 1047 and
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`1048).
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`Beaudoin I teaches methods for extracting lipid fractions from marine and
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`aquatic animal material by using a ketone such as acetone, followed by subjecting
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`the non-soluble and particulate fraction to additional solvent extraction with an
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`alcohol such as ethanol, isopropanol, t-butanol, or an ester of acetic acid, such as
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`ethyl acetate. Ex. 1002, pp. 5-6. Beaudoin I used this extraction process with krill,
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`and analyzed the resulting extracts: “Results on krill oils obtained in accordance
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`with the method of the present invention (fraction I extracted with acetone and
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`fraction II extracted with ethyl acetate) are provided in Tables 13, 14, 15, 16, 17
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`and 18.” (Id., p. 10.) Beaudoin I discloses that lipid fractions from marine and
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`aquatic animals such as krill have a variety of applications in the medical,
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`nutraceutical, and cosmetics fields, and are useful as dietary supplements. (Id., p.
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`1.) Beaudoin I cites marine oils for their beneficial anti-inflammatory properties,
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`their utility in cardiovascular disease, lupus, and renal diseases, and their uses as
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`dietary supplements due to the beneficial effects of omega-3 fatty acids in krill oil.
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`(Id.) Beaudoin I notes that krill contain high concentrations of EPA and DHA.
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`(Id., p. 10.)
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`Beaudoin I was cited during prosecution of the ‘351 patent. However, as
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`described above, the Examiner erroneously relied on the declaratory evidence,
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`Attorney Docket No. AKBM-33544
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`especially the White Declaration, which actually supports the fact that the
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`Beaudoin I extracts contained the claimed phospholipids. Furthermore, the
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`evidence in the van Breemen, Haugsgjerd and Storrø declarations that was
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`received by Patentee in connection with the ‘348 reexamination were not provided
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`to the Examiner even though there was ample time to do so.
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`Petitioner establishes a reasonable likelihood of prevailing with respect to
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`anticipation of claims 1-94 for at least the following reasons. First, the process
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`disclosed in Beaudoin I and the process disclosed in the ‘351 patent are virtually
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`identical. (See Storrø, Ex. 1046 ¶ 7 and Brenna, Ex. 1042 ¶ 63, both of which
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`present a line-by-line comparison of the ‘351 and the Beaudoin I and II methods.)
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`Where the claimed and prior art products are identical or substantially identical in
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`structure or composition, or are produced by identical or substantially identical
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`processes, a prima facie case of either anticipation or obviousness is established. In
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`re Best, 562 F.2d 1252, 1255 (CCPA 1977). The Board’s attention is especially
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`directed to the description of the processes in Beaudoin I, Ex. 1002 p. 5, l. 21-p. 6,
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`l. 20 and the ‘351 patent, Ex. 1001, col. 18, l. 53- col. 19, l. 9. The processes are
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`virtually identical, as would be the resulting extracts. Brenna, Ex. 1042 ¶177.
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`Second, Petitioner provides herein extensive repeat data that demonstrates,
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`in combination with the disclosure of Beaudoin I, the presence of each element by
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`explicit or inherent disclosure in the claims. Brenna, Ex. 1042, ¶¶66-85; 175-211.
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`Independent claims 1 and 94 both specify krill extracts (claim 1) or
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`Antarctic krill extracts (claim 94) that comprise the claimed phospholipids and are
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`suitable for human consumption. Claim 94 adds limitations on the method of
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`extraction, phospholipid content, omega-3 content and astaxanthin content.
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`Beaudoin I discloses lipid extracts from krill (Ex. 1002, pp. 5, l. 7, l. 16-20;
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`p. 8, l. 4-19.) Claim 94 contains no compositional limitations that distinguish
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`Antarctic krill extracts from other krill extracts. Thus, as claimed the krill extracts
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`of Beaudoin I are indistinguishable from Antarctic krill extracts and meet that
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`limitation.
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`With respect to the claimed phospholipids, Beaudoin I discloses that the
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`Fraction I acetone extracts contain 54.1+/-6.1% phospholipids and polar material.
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`The repeat testing and analysis detailed in the Haugsgjerd, Budge and van
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`Breemen Declarations conclusively establishes the presence of the claimed
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`phospholipids in the Beaudoin I extracts. Haugsgjerd (See Ex. 1048, ¶¶2-5) and
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`Budge (See Ex. 1041, ¶¶7-10) repeated the extractions described in Beaudoin I.
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`Haugsgjerd produced both Beaudoin Fraction I and II extracts (Ex. 1048, ¶¶2-5),
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`while Budge produced Fraction I extracts (Ex. 1041, ¶¶7-10). Haugsgjerd’s
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`extractions specifically took into account criticisms of his initial repeats during the
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`‘348 reexamination. (Ex. 1048, ¶4.) The extracts were heated to 60C or 125C or
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`left unheated to address Patentee’s arguments regarding alleged degradation of
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`Attorney Docket No. AKBM-33544
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`phospholipids by heating. Dr. van Breemen analyzed the extracts by mass
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`spectrometry. (Ex. 1040, ¶¶73-85 and ¶¶93-98.) All of the extracts (both
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`Fractions I and II) contained the claimed phospholipids, specifically
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`phosphatidylcholine (PC) with two EPAs attached, two DHA’s attached, and an
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`EPA and DHA attached. Id. Heating did not affect the results. (Id. ¶¶48.) The
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`Beaudoin I extracts necessarily contained the claimed phospholipids.
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`With respect to suitability for human consumption, Beaudoin I reports that
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`the extract fractions were consumed with no side effect. Ex. 1002, p. 12, l. 13-14.
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`With respect to the additional elements in claim 94, the testing and repeat
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`data establishes that the Beaudoin I methods were suitable for preserving an
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`effective amount of the claimed phospholipids when that term is given its broadest
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`reasonable construction. The extracts contained greater than 40% w/w
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`phospholipids (Ex. 1002, 54.1+/-6.1%, Table 14, p. 22), greater than 15% w/w
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`omega-3 (Id., 45.9%, sum of omega-3 in Table 15, p. 22-23), and astaxanthin (Id.,
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`Table 18, p. 27).
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`Independent claim 24 specifies a capsule, tablet, solution, syrup or
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`suspension comprising the same krill extract as defined in claim 1. The Beaudoin I
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`krill oil extracts are solutions as the phospholipids and other components such as
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`astaxanthin are dissolved in the extracts. Brenna, Ex. 1042 ¶202.