`
`
`
`9&6“ng n (us-i l
`R794
`
`Commissionerfnr Patents
`United States Patent and Trademark omce
`P.0.Box1450
`Alexandria, VA 22313-1450
`wwnwsptogcm
`
`3MB
`
`Do NOT USE IN PALM PRINTER
`(THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS)
`...........CASIMIR JONES! 5,0.
`2275 DEMING WAY,
`
`0
`
`MAILED
`
`DEC 2 l 2012
`CENTRAL REEXAMINATION UNIT
`
`SUITE 310
`
`MIDDLETON. WI 53562
`
`EX PARTE REEXAMINATION COMMUNICATION TRANSMITTAL FORM
`
`REEXAMINATION CONTROL NO. 90/012 698.
`
`PATENT NO. 8278351.
`
`ART UNIT 3991.
`
`Enclosed is a copy of the latest communication from the United States Patent and Trademark
`Office in the above identified ex parte reexamination prcceeu’ing (37 CFR 1.550(0).
`
`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(9)).
`
`PTOL—465 (Rev.O7-O4)
`
`000001
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`
`Exhibit
`
`
`
`ENZYMOTEC - 1065
`
`000001
`
`

`

`
`
`Order Granting / Denying Request For
`
`Control No.
`
`90/012,698
`Examiner
`
`Patent Under Reexamination
`
`8278351
`Art Unit
`
`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.
`
`
`
`
`c)|:l Other: Attachments: a)l:] PTO-892,
`MIX PTO/SB/08,
`
`
`
`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 CFR1.550(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. E] The request for ex p.
`
`'mination is DFNIFO
`
`This decision is not appeaiable (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
`AVASLABLE 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:
`
`I
`
`
`
`a) El by Treasury check or,
`
`b) C] by credit to Deposit Account No.
`
`or
`
`c) [:1 by credit to a credit card account, unless othen/vise notified (35 U.S.C. 303(c)).
`
`Primary Examiner, Art Unit 3991 cc:Re-uester
`
`/Bruce Campell/
`
`ifthird uart
`U.S. Patent and Trademark Office
`PTOL-471 (Rev. 08—06)
`
`re-uester
`
`Office Action in Ex Parte Reexamination
`
`Part of Paper No. 20121211
`
`000002
`
`000002
`
`

`

`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 2
`
`Request for Ex Parte Reexamination
`
`A request for ex parte reexamination of claims 1-94 of US. 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 US. Patent 8,278,351. Claim 1 is representative:
`1. A. krill “W1 mmprising:
`a phoprofipiad Mme gmmt formula (is
`
`1')
`
`Ill
`
`o
`
`inc—e—«cmx,
`l
`9.1—c-mo—clm
`
`t,
`
`Hm—d—E——w~—x
`
`wimain R1 and 8.2, cad) «umber w‘fih themam car-
`boxylW to Web mi: in mm met! infiepcn
`denfly represents 3 Muhammad acid (DEA) m an
`mmmoic acid (59m residam and x is
`42111634214143, mchtimcznmw
`
`rm
`0;:
`
`u
`
`1!:
`
`”cm
`
`l}
`my
`
`fl,
`
`3
`
`a
`
`and
`
`whammy the Burris! is swam: for {mama consumptkm.
`
`000003
`
`000003
`
`

`

`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 3
`
`Documents Submitted by. Requester
`
`The following documents were submitted by Requester as the basis for this
`
`Request.
`
`WO 00/23546, 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 sun..-
`
`1. Requester considers claims 1-940 unpatentable over the Neptune final
`
`prospectus as evidenced by Beaudoin l and the Haugsgjerd, van Breemen and Storro
`
`declarations (Request, pp. 8—40).
`
`"i he Neptune tmal prospectus IS a prospectus ior a stock onering Dy" Nethl‘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
`
`000004
`
`

`

`Application/Control Number: 90/012,698
`
`Page 4
`
`Art Unit: 3991
`
`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 Storro declaration cites the
`
`prospectus in its explanation of what Beaudoin | 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 | and the Haugsgjerd, van Breemen and Storro
`
`declarations (Request, pp. 40-71).
`
`The Neptune press release amateur" ” “Mt Neptune “has react
`
`' "“3 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'
`
`Hit/as
`
`applied in a rejection during ;::;;;;ut§ch 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 discrose any new technical information not previousty
`
`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
`
`

`

`Application/Control Number: 90/012,698
`
`Page 5
`
`Art Unit: 3991
`
`Storro 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 a, Ngmmial 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 Beaudoin 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 l, and reasoned that the chemical
`
`COITIPOSlIlUH of the beaudoin extract si'iOuio also be simmer to What is recueu m the
`
`claims. The rejection was withdrawn after Applicant argued that Beaudoin | 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
`
`Beaudoin applications - as “a cold extraction process" (prospectus, p. 12). Requester
`
`also provides the Storro 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 l 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 Hutu 1e. claims "1-94 are patentable. Acco:"“"‘-i” Reaudoin l, 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 l, 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 l is cited for its analysis of the krill oil extract. The Neptune final
`
`prospectus and the Haugsgjerd, van Breemen and Storro 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
`
`000007
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`

`

`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 7
`
`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 l.
`
`A reasonable examiner would consider the disclosure of Beaudoin ll important in
`
`determining whether claims 1-94 are patentable. Accordingly, Beaudoin II 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
`
`' ”'76) 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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`

`

`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 8
`
`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 l
`
`“ “‘“7 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 when; this application or proceeding is assigned is 571-273-9903.
`
`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.usptogov. Should
`you item-’9 questmiits Ui‘l access to me Private I‘HIK system, curitact me fileuti’OIiiC
`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
`
`httpszllefs.uspto.gov/efiIe/myportaI/efs-registered
`
`000009
`
`000009
`
`

`

`Application/Control Number: 90/012,698
`Art Unit: 3991
`
`Page 9
`
`By Mail to:
`
`Mail Stop Ex Pane Reexam
`Central Reexamination Unit
`Commissioner for Patents
`United States Patent & Trademark Office
`PO. 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 Campell/
`Patent Reexamination Specialist
`Central Reexamination Unit 3991
`
`/Padmashri Ponnaluri/
`
`Patent Reexamination Specialist
`CRU 3991
`
`/Deborah Jones/
`
`Supervisory Patent Examiner, Art Unit 3991
`
`0000010
`
`0000010
`
`

`

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`

`F-rsmammveruored
`'“F0RMAT'OND'S°L°SURE
`STATEMENT BY APPL'CA'" ——
`—_
`
`( Not for submission under 37 CFR 1.99)
`
`If you wish to add additional Foreign Patent Document citation information please click the Add button
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`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
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`English language translation is attached.
`
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`
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`'“F0RMAT'°N°'S°L°SURE
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`STATEMENT BY APPLICANT
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`(Not for submission under 37 CFR 1.99)
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`Application Number
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`Filing Date
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`—_
`Attorney Docket Number
`AKBM-32917IUS1/REX
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(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
`
`[I
`
`1:] See attached certification statement.
`
`|:] The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`A certification statement M not submitted herewith.
`
`SIGNATURE
`
`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.
`
`/J. Mitchell Jones/ ,1 Lilichell Jones
`
`
`
`
`Name/Print
`
`Date (YYYYQMM-DD)
`
`2012—10—02
`
`Registration Number
`
`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 Officer, U.S.
`Patent and Trademark Office, US Department of Commerce, PO. 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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`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
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
`that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the US. Patent and Trademark Office is to
`process and/or examine your submission related to 'a patent application or patent.
`If you do not furnish the requested
`information, the US. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
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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 determine 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 aIIOWed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 5523). Records from this system of records may be disclosed to the
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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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`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
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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
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
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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
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
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`A record related to an international Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the lntemational Bureau of the World Intellectual Property Organization, pursuant
`to the Patent Cooperation Treaty.
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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
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
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`We, to the Administrator, General Services, or
`A record from this system of records may be disclosed, as a n
`his/her designee, durim :9" inspection. of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
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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
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in
`an application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
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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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