U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`
`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
`
`
`
`IPR2014-00636
`
`
`
`MOTION FOR JOINDER UNDER 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`

`

`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`I.
`
`Enzymotec Ltd. (“Enzymotec”) respectfully submits this Motion for Joinder,
`
`together with a Petition for Inter Partes Review of U.S. Patent No. 8,278,351,
`
`Petition IPR2014-00636 (the “Enzymotec IPR”). Pursuant to 35 U.S.C. § 315(c)
`
`and 37 C.F.R. § 42.122(b), Enzymotec requests institution of an inter partes
`
`review and joinder with the inter partes review concerning the same patent in Aker
`
`Biomarine AS v. Neptune Technologies and Bioressources, Inc., Case IPR2014-
`
`00003 (the “Aker IPR”), which was instituted on March 24, 2014.
`
`Enzymotec’s request for joinder is timely. Additionally, Enzymotec’s
`
`petition is narrowly-tailored to only one additional claim of the ’351 patent,1 and it
`
`includes only the same two grounds of unpatentability that are the subject of the
`
`Aker IPR. In addition, Enzymotec is willing to streamline discovery and briefing.
`
`Enzymotec has also filed two other IPR petitions and motions for joinder
`1
`
`with respect to the ’351 patent. Specifically, on April 4, 2014, Enzymotec filed
`
`petition IPR2014-00556 (directed to the same claims at issue in Aker’s IPR, i.e.,
`
`claims 1-6, 9, 12, 13, 19-29, 32, 35, 36, and 42-46), together with a motion for
`
`joinder with Aker’s IPR. On April 11, 2014, Enzymotec filed petition IPR2014-
`
`00586 (directed to the claims 47-52, 55, 58, 59, and 65-69), together with a
`
`motion for joinder with Aker’s IPR.
`
`
`
`1
`
`

`

`Accordingly, joinder is appropriate because it will not prejudice the parties to the
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`Aker IPR and will promote the efficient resolution of the question of validity of a
`
`patent in a single proceeding. Absent joinder, Enzymotec will be prejudiced
`
`because its interests may not be adequately represented in the Aker IPR.
`
`II. MATERIAL FACTS
`
`Neptune Technologies and Bioressources, Inc. (“Neptune” or “Patent
`
`Owner”) owns the ’351 patent. On October 2, 2012, Neptune sued Enzymotec in
`
`district court for alleged infringement of this patent. (Neptune et al. v. Enzymotec
`
`et al., D. Del., 1:12cv1253.) On January 29, 2013, Neptune filed a complaint with
`
`the International Trade Commission against Enzymotec and others alleging
`
`violation of 19 U.S.C. § 1337 by importation into the U.S. of articles that allegedly
`
`infringe the ’351 patent. (ITC Investigation No. 337-TA-887, the “ITC
`
`Investigation.”) On May 9, 2013, the district court case against Enzymotec was
`
`stayed pending resolution of the ITC Investigation. On December 16, 2014, the
`
`ITC Investigation was stayed, pending Neptune and Enzymotec’s efforts to
`
`conclude a settlement agreement, but the stay was lifted on April 14, 2014.
`
`On March 24, 2014, the Board instituted Aker’s IPR on claims 1, 3-6, 9, 12,
`
`13, 19-24, 26-29, 32, 35, 36, and 42-46 of the ’351 patent, on the ground of
`
`anticipation by WO 00/23546 to Beaudoin (“Beaudoin I”). (Institution of Inter
`
`
`
`2
`
`

`

`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`Partes Review, Aker IPR, Paper No. 22 at pp. 8-16 (March 24, 2014).) The Board
`
`also instituted inter partes review of these same claims, plus claims 2 and 25, on
`
`the ground of obviousness over Fricke et al., Lipid, Sterol, and Fatty Acid
`
`Composition of Antarctic Krill, LIPIDS, Vol. 19, No. 11, pp. 821-827 (“Fricke”);
`
`Bergelson, Lipid Biochemical Preparations, Elsevier/North-Holland Biomedical
`
`Press (“Bergelson”); JP Pat. App. Pub. Hei 8-231391 (“Yasawa”); Bio and High
`
`Technology Announcement (“Itano”); and WHO News and Activities, Nutritional
`
`Value of Antarctic Krill (“the WHO Bulletin”). (Id. at pp. 21-27.)
`
`The Enzymotec IPR seeks institution of trial with respect to claim 94 of the
`
`’351 patent on two grounds. The first ground is anticipation by Beaudoin I, which
`
`is the identical ground at issue in the Aker IPR. The second ground is obviousness
`
`over Fricke, Bergelson, Yasawa, and Itano. This is also the identical ground at
`
`issue in the Aker IPR, with the exception that Enzymotec’s IPR does not include
`
`the WHO Bulletin, which is one of the prior art references included in the second
`
`ground at issue in the Aker IPR.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`The Leahy-Smith America Invents Act permits joinder of like review
`
`proceedings, e.g., an inter partes review may be joined with another inter partes
`
`review. 37 C.F.R. § 42.122(a). The Board has discretion to join parties to an
`
`
`
`3
`
`

`

`existing inter partes review. 35 U.S.C. § 315(c). In deciding whether to exercise
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`its discretion, the Board considers factors including: (1) the movant’s reasons why
`
`joinder is appropriate; (2) whether the new petition presents any new grounds of
`
`unpatentability; (3) what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) how briefing and discovery may be simplified.
`
`Dell Inc. v. Network-1 Security Solutions, Inc., Decision on Motion for Joinder,
`
`IPR2013-00385, Paper No. 17 at 4 (July 29, 2013).
`
`A. Enzymotec’s Motion For Joinder is Timely
`
`The instant Petition and this Motion for Joinder are timely under 35 U.S.C. §
`
`315(c) and 37 C.F.R. § 42.122(b). While, in general, inter partes review may not
`
`be instituted more than one year after the date on which a petitioner is served with
`
`a complaint alleging infringement of the patent-at-issue (35 U.S.C. § 315(b)), the
`
`one year period does not apply when a petition for inter partes review is
`
`accompanied by a motion for joinder filed within one month of institution of the
`
`inter partes review for which joinder is requested. 37 C.F.R. § 42.122(b). This
`
`Motion for Joinder and the accompanying Petition are timely, as they are submitted
`
`within one month of the March 24, 2014 institution of the Aker IPR.
`
`
`
`4
`
`

`

`B. Joinder is Appropriate
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`Joinder is appropriate because Enzymotec will be unduly prejudiced if
`
`joinder is denied. As noted above, Enzymotec remains a party in the ITC
`
`Investigation and district court case concerning the ’351 patent. The ITC
`
`Investigation had been stayed pending the parties’ efforts to conclude a settlement
`
`agreement, but to date the parties have been unable to reach settlement.
`
`Accordingly the stay was lifted on April 14, 2014, and the hearing will begin on
`
`April 28, 2014. (Order No. 43, Setting Amended Procedural Schedule, ITC
`
`Investigation 337-TA-877.)
`
`At this stage, in order to challenge Neptune’s claims in an inter partes
`
`review, the only option available to Enzymotec is to file its petition and
`
`simultaneously request joinder to Aker’s IPR pursuant to 37 C.F.R. § 42.122(b).
`
`Therefore, absent joinder, Enzymotec’s petition for inter partes review would be
`
`barred. Enzymotec would be prejudiced if the Board refuses joinder, as its
`
`interests may not be adequately represented in the Aker IPR.
`
`In contrast, neither Aker nor Neptune would suffer prejudice if the Board
`
`permits joinder. Enzymotec’s IPR presents the same two grounds of
`
`unpatentability on which the Aker IPR was instituted. The Board instituted inter
`
`partes review on the two grounds noted above. Enzymotec’s petition presents the
`
`
`
`5
`
`

`

`identical Beaudoin I anticipation argument. It also presents the identical
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`obviousness argument using the same combination of prior art, with the exception
`
`that the Enzymotec IPR does not rely on the WHO Bulletin, which is at issue in the
`
`Aker IPR.
`
`The Enzymotec IPR is limited to a single claim (claim 94), which contains
`
`several limitations that are already at issue in the Aker IPR. Each limitation of
`
`claim 94 is addressed below:
`
`“An Antarctic krill oil extract comprising”: Compare this subject matter to
`
`that of claims 1 and 24 at issue in the Aker IPR, which also relate to krill extracts.
`
`(See ’351 Patent, Exhibit 1001.) Although claim 94 adds the word “Antarctic,”
`
`there is no element in claim 94 that distinguishes Antarctic krill extracts from any
`
`other krill extract. Moreover, the evidence cited in support of unpatentability of
`
`this limitation in both the Enzymotec and Aker petitions is identical. Compare
`
`Aker IPR Petition (attached hereto as Appendix A) at p. 18 (citing Beaudoin, Ex.
`
`1002, p. 5, l. 7, l. 16-20; p. 8, l. 4-19) with Enzymotec IPR Petition at p. 18 (citing
`
`same); Aker IPR Petition at pp. 40, 57 (citing Fricke, Ex. 1006, p. 821, col. 2) with
`
`Enzymotec IPR Petition at p. 21-22 (citing same).
`
`
`
`6
`
`

`

`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`“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 eicosapentanoic acid (EPA) residue, and X is --CH2CH2NH3, --
`
`CH2CH2N(CH3)3, or
`
`”: The essentially identical limitation
`
`appears in claims 1 and 24 of the ’351 patent, which are at issue in the Aker IPR.
`
`“the extract is extracted under conditions suitable for preserving an
`
`effective amount of phospholipid having two independently selected fatty acid
`
`chains within the same molecule selected from EPA and DHA”: The presence of
`
`the referenced phospholipid in prior art krill extracts is already at issue in the Aker
`
`IPR, as are the extraction processes used in the prior art. See Aker IPR Petition at
`
`pg. 11. Moreover, the evidence Enzymotec cites in support of unpatentability of
`
`this limitation is already at issue in the Aker IPR. Compare Aker IPR Petition at
`
`pp. 18-19, 40-41, and 57 to Enzymotec IPR Petition at pp. 18-19, and 22.
`
`
`
`7
`
`

`

`“the extract comprises phospholipids in an amount of at least 40% w/w”:
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`Compare this subject matter to that of claims 2, 3, 25, and 26 at issue in the Aker
`
`IPR. Claims 2 and 25 require that the krill extract have a total phospholipid
`
`concentration of about 40% w/w, wherein about represents ± 10%. Claims 3 and
`
`26 require that the krill extract have a total phospholipid concentration of about
`
`45% w/w, wherein about represents ± 20%. The evidence Enzymotec cites in
`
`support of unpatentability of the phospholipid concentration of “at least 40%” in
`
`claim 94 is identical to evidence Aker cited in support of unpatentability of the
`
`“about 40%” and “about 45%” phospholipid limitations in claims 2, 3, 25, and 26.
`
`Compare Aker IPR Petition at pp. 20, 42, and 57 to Enzymotec IPR Petition at pp.
`
`19 and 22. Enzymotec additionally cites support from the Brenna, Budge, and
`
`Moore declarations (see Enzymotec IPR Petition at 19), which are already at issue
`
`in the Aker IPR.
`
`“the extract comprises omega-3 fatty acids in an amount of at least 15%
`
`w/w”: The amount of polyunsaturated fatty acids, and specifically the amount of
`
`omega-3 fatty acids, present in the prior art krill extracts is already at issue in the
`
`Aker IPR, e.g., via claims 9 and 32. The evidence Enzymotec cites in support of
`
`unpatentability of this limitation in claim 94 is identical to evidence Aker cited in
`
`support of unpatentability of claims 9 and 32 in the Aker Petition. Compare Aker
`
`
`
`8
`
`

`

`IPR Petition at pp. 21, 43, and 57 to Enzymotec IPR Petition at pp. 19-20 and 22-
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`23. Enzymotec additionally cites support from the Brenna, Budge, and Lee
`
`declarations (see Enzymotec IPR Petition at 19-20), which are already at issue in
`
`the Aker IPR.
`
`“the extract comprises astaxanthin”: The issue of whether astaxanthin is
`
`present in prior art krill extracts is already at issue in the Aker IPR, e.g., via claims
`
`23 and 46. The evidence Enzymotec cites in support of unpatentability of this
`
`limitation in claim 94 is identical to evidence Aker cited in support of
`
`unpatentability of claims 23 and 46 in the Aker Petition. Compare Aker IPR
`
`Petition at pp. 22, 43, and 57 to Enzymotec IPR Petition at pp. 20 and 23.
`
`Enzymotec additionally cites support from the Brenna, Budge, and Lee
`
`declarations (see Enzymotec IPR Petition at 20), which are already at issue in the
`
`Aker IPR.
`
`“the extract is suitable for human consumption”: The identical limitation
`
`appears in claims 1 and 24 at issue in the Aker IPR. See ’351 patent (Exhibit
`
`1001), claims 1, 24, and 94.
`
`Thus, substantive issues in the Aker IPR would not be unduly complicated
`
`by joining the Enzymotec IPR because the joinder does not introduce any new
`
`prior art, expert declarations, or grounds of unpatentability. Accordingly,
`
`
`
`9
`
`

`

`Enzymotec respectfully submits that the Patent Owner would not need substantial
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`time to complete its Preliminary Patent Owner’s Response, should it choose to file
`
`one.2
`
`Accordingly Enzymotec believes that joinder would have little, if any,
`
`impact on the trial schedule set in Aker’s IPR, and will require substantially no
`
`additional time or cost on the Patent Owner’s part. Given that Aker and
`
`Enzymotec will be addressing the same prior art and same bases for rejection using
`
`the same experts, Enzymotec envisions virtually no differences in positions.
`
`Because the experts are the same, no additional depositions are needed, and
`
`Enzymotec is willing to have Aker take the lead at depositions, with Enzymotec
`
`asking limited, supplemental questions (if any). Further, Enzymotec will seek to
`
`cooperate with Aker to simplify briefing and discovery whenever possible, and is
`
`In fact, Neptune’s Patent Owner Preliminary Response to Aker’s IPR
`2
`
`already addressed claim 94, because Aker originally filed its IPR against every
`
`claim of the ’351 patent. (See Petition for Inter Partes Review, Aker IPR (Oct. 1,
`
`2013); Patent Owner Preliminary Response, Aker IPR (Jan. 2, 2014).) After
`
`Neptune filed its Patent Owner Preliminary Response, Aker and Neptune filed a
`
`joint motion to limit the claims at issue. (Joint Motion to Limit Petition, Aker IPR
`
`(Jan. 30, 2014).)
`
`
`
`10
`
`

`

`amenable to consolidated filings. Conducting the proceeding in this manner
`
`U.S. Patent 8,278,351
`Petition for Inter Partes Review
`Motion for Joinder
`
`
`should minimize cost, complication, and delay, and should not unduly affect the
`
`Board’s ability to issue its final determination within the statutorily-defined time
`
`limit.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Enzymotec respectfully requests that the Board
`
`institute its Petition for Inter Partes Review of U.S. Patent 8,278,351 (IPR2014-
`
`00636) and join this proceeding with Aker Biomarine AS v. Neptune Technologies
`
`and Bioressources, Inc. (IPR2014-00003).
`
`Although it is believed that no fee is required for this Motion, the
`
`Commissioner is hereby authorized to charge any additional fees which may be
`
`required for this Motion to Deposit Account No. 11-0600.
`
`Dated: April 23, 2014
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`/ Elizabeth J. Holland /
`Elizabeth J. Holland (Reg. No. 47,657)
`Cynthia Lambert Hardman (Reg. No.
`53,179)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004-1007
`Tel: (212) 425-7200
`Fax: (212) 425-5288
`
`Counsel for Enzymotec Ltd.
`
`11
`
`

`

`
`
`
`
`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that “MOTION FOR JOINDER UNDER
`
`37 C.F.R. §§ 42.22 AND 42.122,” was served in its entirety by Federal Express
`
`overnight service, Tracking No. 798634081522, on this 23rd day of April 2014 on
`
`the following:
`
`
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, DC 20004
`
`Patent owner’s correspondence address
`of record for U.S. Patent 8,278,351
`
`
`Dated: April 23, 2014
`
`
`
`
`
`/ Cynthia Lambert Hardman /
`Elizabeth J. Holland ((Reg. No. 47,657)
`Cynthia Lambert Hardman (Reg. No.
`53,179)
`KENYON & KENYON LLP
`One Broadway
`New York, NY 10004
`Tel: (212) 425-7200
`Fax: (212) 425-5288
`
`Counsel for Petitioner Enzymotec Ltd.
`
`
`
`
`
`
`

`

`
`
`
`
`
`APPENDIX A
`
`APPENDIX A
`
`

`

`Attorney Docket No. AKBM-33544
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`

`

`Attorney Docket No. AKBM-33544
`
`
`
`TABLE OF CONTENTS
`
`
`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 
`
`I.  THE ‘351 PATENT ............................................................................................................ 3 
`
`II.  PERSON OF SKILL IN THE ART AND STATE OF THE ART ..................................... 6 
`
`III.  CLAIM CONSTRUCTION ................................................................................................ 8 
`
`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 
`
`
`
`i
`
`

`

`Attorney Docket No. AKBM-33544
`
`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 
`
`V.  CONCLUSION ..................................................................................................................... 60 
`
`
`
`
`
`
`
`ii
`
`

`

`Attorney Docket No. AKBM-33544
`
`
`
`
`
`INTRODUCTION
`
`Aker Biomarine AS’s (“Petitioner”) Petition for Inter Partes Review
`
`(“Petition”) seeks cancellation of claims 1-94 (“challenged claims”) of U.S. Pat.
`
`No. 8,278,351 to Sampalis titled “Natural Marine Source Phospholipids
`
`Comprising Polyunsaturated Fatty Acids and Their Applications” (the ‘351
`
`patent)(Exhibit (“Ex.”) 1001)). Concurrently filed herewith are a Power of
`
`Attorney and Exhibit List pursuant to § 42.10(b) and § 42.63(e), respectively. The
`
`Office is authorized to charge fee deficiencies to Deposit Account 50-4302.
`
`NOTICE OF LEAD AND BACKUP COUNSEL
`
`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
`
`NOTICE OF EACH REAL PARTY IN INTEREST
`
`Aker Biomarine AS, Fjordallèen 16, P.O. Box 1423 Vika, Oslo Norway
`
`0115 is the real party in interest for Petitioners. Aker Biomarine AS is a wholly
`
`owned subsidiary of Aker ASA.
`
`NOTICE OF RELATED MATTERS
`
`
`
`1
`
`

`

`Attorney Docket No. AKBM-33544
`
`The ‘351 patent is the subject of a patent infringement lawsuit filed on
`
`October 1, 2012 in the United States District Court of Delaware (C.A. No. 12-
`
`1252-GMS) and International Trade Commission (ITC) action Investigation No.
`
`337-TA-877. The ‘351 patent is also the subject of an Ex Parte Reexamination,
`
`Control No. 90/012,698, the request for which has been granted. See Ex. 1065.
`
`The ‘351 patent is a continuation of U.S. Pat. 8,030,348 (the “’348 patent”; Ex.
`
`1069), which is currently subject to an Inter Partes Reexamination with the control
`
`number 95/001,774. All claims are currently rejected in the Action Closing
`
`Prosecution. (See Ex. 1064.) The ‘348 patent is also the subject a patent
`
`infringement lawsuit filed by Neptune Bioressources & Technologies against Aker
`
`Biomarine in the United States District Court of Delaware (1:11-cv-00894-GMS).
`
`NOTICE OF SERVICE INFORMATION
`
`Please address all correspondence to lead counsel at the address shown
`
`above. Petitioner also consents to electronic service by email to:
`
`docketing@casimirjones.com.
`
`GROUNDS FOR STANDING
`
`Petitioner certifies that the ‘351 patent is available for inter partes review
`
`and that Petitioner is not barred or estopped from requesting an inter partes review
`
`challenging the patent claims on the Grounds identified in this petition.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`
`
`2
`
`

`

`Attorney Docket No. AKBM-33544
`
`Petitioner requests inter partes review and cancellation of claims 1-94 of the
`
`’351 patent based on one or more of the grounds under 35 U.S.C. §102 or 103 set
`
`forth herein. Petitioner’s detailed statement of the reasons for the relief requested is
`
`set forth below in the section “Statement of Reasons for Relief Requested.”
`
`THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
`
`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 challenged
`
`in the petition." 35 U.S.C. § 314(a). The Petition meets this threshold. Each of
`
`the elements of claims 1-94 of the ’351 patent are taught in the prior art as
`
`explained below in the proposed Grounds for Unpatentability. Additionally, for
`
`those Grounds under 35 U.S.C. § 103(a), the motivation to combine is provided.
`
`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 27, 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
`
`
`
`3
`
`

`

`Attorney Docket No. AKBM-33544
`
`2258. 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:
`
`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 27, 2002 filing date of PCT/CA02/01185.
`
`
`
`4
`
`

`

`Attorney Docket No. AKBM-33544
`
`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 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 terminal
`
`disclaimers April 2, 2012 to overcome the double patenting rejections. 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, ¶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.
`
`
`
`5
`
`

`

`Attorney Docket No. AKBM-33544
`
`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
`
`
`
`6
`
`

`

`Attorney Docket No. AKBM-33544
`
`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 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.
`
`
`
`7
`
`

`

`Attorney Docket No. AKBM-33544
`
`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. 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, ¶ 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. With the exception of “about,” Petitioner does not believe that the
`
`applicant, acting as its own lexicographer, attributed any special