`(THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS)
`..........&.ASIMlR JONES’
`
`2275 DEMING WAY,
`
`SUITE 310
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`MIDDLETON, WI 53562
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`NB
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`l>o«€5\’\~°310i ri (us-\ I
`Pix
`
`Commissionerfnr Patents
`United States Patent and Trademark Omce
`P.O. BOX1450
`Alexandria, VA 22313-1450
`wvwuuspto.gcm
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`MAILED
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`2 I
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`CENTRAL REEXAMINATION UNIT
`
`EX PARTE REEXAMINATION COMMUNICATION TRANSMITTAL FORM
`
`REEXAMINATION CONTROL NO. 90/012 698.
`
`PATENT NO. 8278351.
`
`ART UNIT 3991.
`
`t. 1I
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`Cf‘)
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`I‘-J
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`Enclosed is a copy of the latest communication from the United States Patent and Trademark
`Office in the above identified ex parte reexamination prccecding (37 CFR 1.550(f)).
`
`Where this copy is supplied after the reply by requester, 37 CFR 1.535, or the time for filing a
`reply has passed, no submission on behalf of the ex parte reexamination requester will be
`acknowledged or considered (37 CFR 1.550(g)).
`
`PTOL-465 (Rev.O7-O4)
`
`000001
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`Exhibit
`
`
`
`ENZYMOTEC - 1065
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`000001
`
`
`
`Patent Under Reexamination
`
`8278351
`Art Unit
`
`Control No.
`
`90/012,698
`Examiner
`
`
`
`Order Granting / Denying Request For
`
`BRUCE CAMPELL
`
`Ex Parte Reexamination
`
`--The MAILING DA TE of this communication appears on the cover sheet with the correspondence address--
`
`
`
` The request for ex parte reexamination filed 02 October 2012 has been considered and a determination has
`been made. An identification of the claims, the references relied upon, and the rationale supporting the
`
`determination are attached.
`
`
`b)IXI PTO/SB/08,
`
` c)|:I Other: Attachments: a)I:] PTO-892,
`
`
`
`1. [XI The request for ex parte reexamination is GRANTED.
`
`RESPONSE TIMES ARE SET AS FOLLOWS:
`
`For Patent Owner's Statement (Optional): TWO MONTHS from the mailing date of this communication
`(37 CFR 1.530 (b)). EXTENSIONS OF TIME ARE GOVERNED BY 37 CFR1.55’l(c).
`
`For Requester's Reply (optional): TWO MONTHS from the date of service of any timely filed
`Patent Owner's Statement (37 CFR 1.535). NO EXTENSION OF THIS TIME PERIOD IS PERMITTED.
`If Patent Owner does not file a timely statement under 37 CFR 1.530(b). then no reply by requester
`is permitted.
`
`2. I:] The request for ex p.
`
`imination is DIZNIIZD
`
`This decision is not appealable (35 U.S.C. 303(c)). Requester may seek review by petition to the
`Commissioner under 37 CFR 1.181 within ONE MONTH from the mailing date of this communication (37
`CFR 1.515(c)). EXTENSION OF TIME TO FILE SUCH A PETITION UNDER 37 CFR 1.181 ARE
`AvAi£Ji.BLE ONLY BY PETITION TO SUSPEND OR WAIVF THE REGULATIONS UNDER
`37 CFR 1.183.
`
`In due course, a refund under 37 CFR 1.26 ( c ) will be made to requester:
`
`5
`I
`
`
`
`a) El by Treasury check or,
`
`b) C] by credit to Deposit Account No.
`
`OF
`
`,
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`c) [:1 by credit to a credit card account, unless othen/vise notified (35 U.S.C. 303(c)).
`
`
`
`/Bruce Campelll
`Primary Examiner, Art Unit 3991
`
`ifthird art reuester
`cc:Reuester
`U.S. Patent and Trademark Office
`PTOL-471 (Rev. 08-06)
`
`Office Action in Ex Parte Reexamination
`
`Part of Paper No. 20121211
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`000002
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`000002
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`
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`Application/Control Number: 90/012,698
`Art Unit: 3991
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`Page 2
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`Request for Ex Parte Reexamination
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`A request for ex parte reexamination of claims 1-94 of U.S. Patent 8,278,351 was
`
`filed October 2, 2012 by a third party requester.
`
`Decision on Request
`
`A substantial new question of patentability (SNQ) affecting claims 1-94 of United
`
`States Patent Number 8,278,351 is raised by the request for ex parte reexamination.
`
`Claims
`
`In reexamination, patent claims are construed broadly. In re Yamamoto, 740 F.2d
`
`1569, 1571, 222 USPQ 934, 936 (Fed. Cir. 1984) (claims given "their broadest
`
`reasonable interpretation consistent with the specification"). This Request is directed to
`
`claims 1-94 of U.S. Patent 8,278,351. Claim 1 is representative:
`1. A. krill’ extract mmprisizxg:
`a phmzpbolipiad cfthe general farrnulzn (is
`
`O
`
`o
`
`u;I:—c:»——c--cx,
`I
`9.,—»c-~c:—r.fi«;
`
`i.
`
`H,¢;t——G—E-—e.>~—x
`
`wltemin R1 and R2, cad: wugaher wgth the tdsperstivc car-
`isoxyl gmtlpi to which each in
`each
`dandy represents a dncomhuatacxmvie acid (DEA) car an
`eémsapemmoic
`acid (EEPM residue-
`and X is
`——-(T.Tt1',(:l1,I~‘ll_.,
`t.1{,cfH,~;c:H,i,..or
`
`rm
`0;:
`
`22
`
`1!:
`
`Mézsi
`
`I1
`my
`
`“
`
`3
`
`0
`
`and
`
`the charm is sttitabic far human cunsumptfmu.
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`000003
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`000003
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`
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`Application/Control Number: 90/012,698
`Art Unit: 3991
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`Page 3
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`Documents Submitted by. Requester
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`The following documents were submitted by Requester as the basis for this
`
`Request.
`
`WO O0/23546, published April 27, 2000 by Beaudoin et al. (Beaudoin l)
`
`Canadian Application 2,251,265, published April 21, 2000 by Beaudoin et al. (Beaudoin
`ll)
`
`WO 97/39759, published October 30, 1997 by Stoll
`
`Neptune Final Prospectus dated May 11, 2001
`
`Neptune Press Release dated June 14, 2001
`
`Beaudoin l was applied in a rejection during prosecution of the ‘351 patent. Beaudoin II
`
`and Stoll were cited in an information disclosure statement but not relied upon by the
`
`examiner. None of the other references were considered during prosecution of the ‘351
`
`patei
`
`Requester has also submitted evidentiary declarations under 37 CFR 1.132 by
`
`Bjorn Ole Haugsgjerd, Richard B. van Breemen and Ivar Storro.
`
`Requester’s Proposed S-'”"-‘
`
`1. Requester considers claims 1-940 unpatentable over the Neptune final
`
`prospectus as evidenced by Beaudoin I and the Haugsgjerd, van Breemen and Storro
`
`declarations (Request, pp. 8-40).
`
`‘i he Neptune tmal prospectus is a prospectus for a SIOCK onering Dy’ Nt3§;)tUl“le,
`
`the assignee of the ‘351 patent and apparently the licensee of the Beaudoin
`
`applications / patents. The prospectus describes in general terms Neptune’s krill oil
`
`product and the method by which it is made, and cites the Beaudoin applications (pp.
`
`11-14). The prospectus does not disclose that the Neptune krill oil contains lipids as
`
`recited in the ‘351 patent claims. Beaudoin l, which Requester cites as "evidence," was
`
`000004
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`000004
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`
`
`Application/Control Number: 90/012,698
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`Page 4
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`Art Unit: 3991
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`applied in a rejection during prosecution of the ‘351 patent (discussed further below).
`
`Therefore the prospectus does not appear to disclose any new technical information
`
`that was not considered during examination of the ‘351 patent. The Haugsgjerd and
`
`van Breemen declarations do not discuss the Neptune prospectus and are therefore not
`
`evidence relating to the prospectus. Similarly, the Storrrzs declaration cites the
`
`prospectus in its explanation of what Beaudoin I discloses, but does not provide any
`
`evidence regarding the prospectus.
`
`Because it does not disclose any new technical information not previously
`
`considered by the Office during prosecution of the ‘351 patent, the Neptune final
`
`prospectus does not raise a SNQ with regard to claims 1-94.
`
`2. Requester considers claims 1-94 unpatentable over the Neptune press
`
`release as evidenced by Beaudoin I and the Haugsgjerd, van Breemen and Storro
`
`declarations (Request, pp. 40-71).
`
`The Neptune press release ans‘-.cu‘i“ ” "Mt Neptune “has react
`
`T "'"= final
`
`stage to obtain a patent” based, apparently, on the Beaudoin applications. The press
`
`release describes in general terms Neptune's krill oil product and the method by which it
`
`is made. The press release does not disclose that the Neptune krill oil contains lipids as
`
`recited in the ‘351 patent claims. Beaudoin l, which Requester cites as "evidence." was
`
`applied in a rejection during ;::;;;.;;;t§;;r. of the ‘351 patent (discussed further below).
`
`merefore the press release does not appear to disclose any new technical information
`
`that was not considered during examination of the ‘351 patent. The Haugsgjerd, van
`
`Breemen and Storro declarations do not discuss the Neptune press release and are
`
`therefore not evidence relating to the press release.
`
`Because it does not disclose any new technical information not previously
`
`considered by the Office during prosecution of the ‘351 patent, the Neptune press
`
`release does not raise a SNQ with regard to claims 1-94.
`
`3. Requester considers claims 1-94 unpatentable over Beaudoin I alone, as
`
`evidenced by the Neptune final prospectus and the Haugsgjerd, van Breemen and
`
`000005
`
`000005
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`
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`Application/Control Number: 90/012,698
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`Page 5
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`Art Unit: 3991
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`Storm declarations. Alternatively, Requester considers claims 1-94 unpatentable over
`
`Beaudoin l in combination with the Neptune final prospectus, the Neptune press
`
`release and Stoll, as evidenced by the Haugsgjerd, van Breemen and Storro
`
`declarations (Request, pp. 72-108 and 137-168).
`
`_ The above proposed SNQ based on Beaudoin I alone is based solely on patents
`
`and/or printed publications already cited/considered in an earlier concluded examination
`
`of the patent being reexamined. On November 2, 2002, Public Law 107-273 was
`enacted. Title III, Subtitle A, Section 13105, part (a) of the Act revised the reexamination
`
`statute by adding the following new last sentence to 35 U.S.C. 303(a) and 312(a):
`
`"The existence of a substantial new question of patentability is not precluded by
`
`the fact that a patent or printed publication was previously cited by or to the Office or
`
`considered by the Office.”
`
`For any reexamination ordered on or after November 2, 2002, the effective date
`
`of the statutory revision, reliance on previously cited/considered art, i.e., “old art,” does
`
`not necessarily preclude the existence of z- ..-.;-.u...;al new question of patentability
`
`(SNQ) that is based exclusively on that old art. Rather, determinations on whether a
`
`SNQ exists in such an instance shall be based upon a fact—specific inquiry done on a‘
`
`case-by-case basis.
`
`in the present instance, there exists a SNQ based solely on Beauooi.‘i l. A
`
`discussion of the specifics now follows:
`
`Beaudoin I was applied in a rejection under 35 U.S.C. § 102(b) during
`
`prosecution of the ‘351 patent. The examiner noted that the claimed krill extract is
`
`produced by methods similar to those of Beaudoin I, and reasoned that the chemical
`
`C0[TIp0$l1lUi'l oi the Ezeaudoin exuact siiouiu also be similar to vmat is lbtltcu ill the
`
`claims. The rejection was withdrawn after Applicant argued that Beaudoin I heated the
`
`extract, which would destroy the phospholipid species recited in the claims. The
`
`Request presents evidence that Beaudoin I did not heat the krill oil extract. Requester
`
`points to the Neptune press release and Neptune prospectus, which characterize
`
`Neptune’s extraction process — apparently the extraction process disclosed in the
`
`000006
`
`000006
`
`
`
`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 6
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`Beaudoin applications - as “a cold extraction process” (prospectus, p. 12). Requester
`
`also provides the Storm declaration, which asserts that Beaudoin did not heat the krill
`
`oil extracts, only heating samples of the extract used for chemical analysis. Finally, the
`
`van Breemen declaration submitted with the Request shows that krill extracts produced
`
`by the Beaudoin I method (detailed in the Haugsgjerd declaration) contain the claimed
`
`phospholipid species whether they are heated or not. Therefore the Beaudoin l
`
`reference is being presented in a new light compared to the prosecution history of the
`
`'351 patent.
`
`Stoll discloses a method for treating bipolar disorder with omega—3
`
`phophatidylcholine, which is defined so as to include the lipid species recited in the ‘351
`
`patent claims (pp. 3-4, 8, Stoll claims 10-15). This is relevant to the claimed
`
`formulations and nutraceuticals, as Stoll states that oral administration is most
`
`convenient (p. 5, line 14).
`
`A reasonable examiner would consider the disclosure of Beaudoin l important in
`
`....;.....g ....eme. claims 1-94 are patentable. Acco:“r""“~"-' Reaudoin I, alone or in
`
`combination with the Neptune final prospectus, the Neptune press release and Stoll,
`
`raises a SNQ with regard to claims 1-94.
`
`4. Requester considers claims 1-94 unpatentable over Beaudoin II, as
`
`evidenced by Beaudoin I, the Neptune final prospectus and the Haugsgjerd, van
`
`Breemen and Storm declarations (Request, pp. 109-136).
`
`Beaudoin II is the priority application for Beaudoin I.
`
`It discloses essentially the
`
`same extraction procedure as Beaudoin I, except a different solvent was used in one
`
`step of the process.
`
`Beaudoin I is cited for its analysis of the krill oil extract. The Neptune final
`
`prospectus and the Haugsgjerd, van Breemen and Storm declarations are relied upon
`
`as discussed above. The van Breemen declaration submitted with the Request shows
`
`that krill extracts produced by the Beaudoin ll method (detailed in the Haugsgjerd
`
`000007
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`000007
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`
`
`Application/Control Number: 90/012,698
`Art Unit: 3991
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`Page 7
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`declaration) also contain the claimed phospholipid species whether they are heated or
`
`not.
`
`While Beaudoin ll was not cited by the examiner during prosecution of the '351
`
`patent, its disclosure is substantially similar to Beaudoin I. This information is being
`
`viewed in a new light for the reasons discussed above for Beaudoin I.
`
`A reasonable examiner would consider the disclosure of Beaudoin ll important in
`
`determining whether claims 1-94 are patentable. Accordingly, Beaudoin ll raises a SNQ
`
`with regard to claims 1-94.
`
`Conclusion
`
`In view of the analysis above, the request for reexamination is GRANTED.
`
`Claims 1-94 of US Patent 8,278,351 will be reexamined.
`
`Duty to Disclose
`
`The patent owner is reminded of the continuing responsibility under 37 CFR
`
`’ ”""’f=) to apprise the Office of any litigation activity, or other prior or concurrent
`
`proceeding, involving Patent No. 8,278,351 throughout the course of this reexamination
`
`proceeding. The third party requester is also reminded of the ability to similarly apprise
`
`the Office of any such activity or proceeding throughout the course ’ this reexamination
`
`proceeding. See MPEP §§ 2207, 2282 and 2286.
`
`Waiver of Right to File Patent Owner Statement
`
`In a reexamination proceeding, Patent Owner may waive the right under 37
`
`C.F.R. 1.530 to file a Patent Owner Statement. The waiver document must contain a
`
`statement that Patent Owner waives the right under 37 C.F.R. 1.530 to file a Patent
`
`Owner Statement and proof of service in the manner provided by 37 C.F.R. 1.248, if the
`
`request for reexamination was made by a third party requester (see 37 C.F.R 1.550(f)).
`
`Amendment in Reexamination Proceedings
`
`000008
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`000008
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`
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`Application/Control Number: 90/012,698
`Art Unit: 3991
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`Page 8
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`Patent owner is notified that any proposed amendment to the specification and/or
`claims in this reexamination proceeding must comply with 37 CF R 1.530(d)-(j), must be
`
`formally presented pursuant to 37 CFR 1.52(a) and (b), and must contain any fees
`
`required by 37 CFR 1.20(c).
`
`Service of Papers
`
`After the filing of a request for reexamination by a third party requester, any
`
`document filed by either the patent owner or the third party requester must be served on
`
`the other party (or parties where two or more third party requester proceedings are
`
`merged) in the reexamination proceeding in the manner provided in 37 CFR 1.248. See
`
`37 CFR1.550(f).
`
`Correspondence
`
`Any inquiry <
`
`“ '““‘"“j this communication or earlier communications from the
`
`examiner should be directed to BRUCE CAMPELL whose telephone number is 571-
`
`272-0974. The examiner can normally be reached on Monday - Thursday from 8:00 to
`
`5:00. The examiner can also be reached on alternate Fridays.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Deborah Jones, can be reached on 571-272-1535. The fax phone number
`
`for the organization whole this application or proceeding is assigned is 571-273-9553.
`
`Information regarding the status of an application may be obtained from the
`Patent Application Information Retrieval (PAIR) system. Status information for
`published applications may be obtained from either Private PAIR or Public PAIR.
`Status information for unpublished applications is available through Private PAIR only.
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`you «acme 'q..x;::;t.'uti5 on access l.U me mivate I‘/-kin system, Coiltact me ii:iE:L;'Li’0I“uC
`Business Center (EBC) at 866-217-9197 (toll-free).
`
`All correspondence relating to this ex parte reexamination proceeding should be
`directed:
`
`By EFS:
`
`Registered users may submit via the electronic filing system EFS-Web at
`
`https://efs.uspto.gov/efile/myportaI/efs-registered
`
`000009
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`000009
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`
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`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 9
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`By Mail to:
`
`Mail Stop Ex Pane Reexam
`Central Reexamination Unit
`Commissioner for Patents
`United States Patent & Trademark Office
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`By FAX to:
`
`(571) 273-9900
`Central Reexamination Unit
`
`By hand:
`
`Customer Service Window
`Randolph Building
`.401 Dulany Street
`Alexandria, VA 22314
`
`/Bruce Campelll
`Patent Reexamination Specialist
`Central Reexamination Unit 3991
`
`/Padmashri Ponnaluril
`
`Patent Reexamination Specialist
`CRU 3991
`
`/Deborah Jones/
`
`Supervisory Patent Examiner, Art Unit 3991
`
`0000010
`
`0000010
`
`
`
`PTOISBI08a (01-10)
`Doc code; [)3
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`STATEMENT BY APPLICANT
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`(Not for submission under 37 CFR 1.99)
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`ttorney Docket Number
`
`AKBM-32917/US1/REX
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`Examine Cite Foreign Document
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`lnitial
`No Number3
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`Code? |
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`__ Iflniirorgitra do Qhny1‘qrn.')I(Q_
`’ Bl iii.
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`Hospital, et al.
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`I 1997_10_30
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`Brigham and Women's
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`CA
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`20D0_04_21
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`Universite de Sherbrooke,
`el al.
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`EFS Web 2.1.17
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`0000011
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`0000011
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`'”F°'*”“'°"°'S°L°S“RE
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`NON-PATENT LITERATURE DOCUMENTS
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`include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
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`LAAIVIINER blxziw-‘u unu
`
`12/12/2012
`/Bruce Campelll
`‘EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`‘ See Kind Codes of USPTO Patent Documents at wvvw.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the tvvo-letter oode (WIPO
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`‘ Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here i
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`EFS Web 2.1.17
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`0000012
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`0000012
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`NFORMAHON [NSCLOSURE
`STATEMENT BY APPLICANT
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`ttorney Docket Number
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`AKBM—32917IUS1/REX
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate se|ection(s):
`
`CERTIFICATION STATEMENT
`
`|:l
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`I
`
`l___I
`
`1:] See attached certification statement.
`
`|:] The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
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`A certification statement .0 not submitted herewith.
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`SIGNATURE
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`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
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`/J. Mitchell Jonesl .1 I.‘.Ji:hell Jones
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`Name/Print
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`Date (YYYYW-‘ill/1M-DD)
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`2012-10-02
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`Registration Number
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`44174
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`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
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`require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Omcer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
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`EFS Web 2.1.17
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`0000013
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`0000013
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
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`The information provided by you in this form will be subject to the following routine uses:
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`Department of Justice to detennine whether the Freedom of Information Act requires disclosure of these record 5.
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`1.
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`The information on this form will be treated confidentially to the extent allowed under the Freedom of information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`U.
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`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
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`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
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`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
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`A record related to an lnternational Application filed under the Patent Cooperation Treaty in this system of records
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`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
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`\4«V4\¢| to the Administrator, General Services, or
`A record from this system of records may be disclosed, as a v
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`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record
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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
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`EFS Web
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`4
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`0000014