UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`15/976, 130
`
`05/10/2018
`
`Inge Bruheim
`
`AKBM-14409/US-18/CON
`
`5089
`
`Casimir Jones, S.C.
`2275 Deming WaySte 310
`Middleton, WI 53562
`
`WARE,DEBORAH K
`
`ART UNIT
`
`1651
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/13/2018
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`docketing @casimirjones.com
`pto.correspondence @ casimirjones.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Office Action Summary
`
`Application No.
`15/976,130
`Examiner
`DEBORAH K WARE
`
`Applicant(s)
`Bruheim et al.
`Art Unit
`1651
`
`AIA Status
`No
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133}.
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)[¥] Responsive to communication(s) filed on 02 November2018.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a)l¥) This action is FINAL.
`2b) C) This action is non-final.
`3)() An election was made bythe applicant in responseto a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`4) Since this application is in condition for allowance except for formal matters, prosecution as to the meritsis
`closed in accordance with the practice under Exparfe Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`6 7
`
`Disposition of Claims*
`1-6,8-15 and 17-20 is/are pending in the application.
`5)
`Claim(s)
`5a) Of the above claim(s)__ is/are withdrawn from consideration.
`C] Claim(s} _is/are allowed.
`Claim(s) 1-6,8-15 and 17-20 is/are rejected.
`8) ( Claim(s)__ is/are objected to.
`9)
`(4 Claim(s)
`are subject to restriction and/or election requirement
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)() The specification is objected to by the Examiner.
`11) The drawing(s) filed on __is/are: a). accepted or b)(_) objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)() Acknowledgmentis made ofa claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)1) None of the:
`b)( Some**
`a)Q All
`1.1) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.1) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) [[] Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(7) Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20181207
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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`The present application is being examined under the pre-AlA first to invent provisions.
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`Claims 1-6, 8-15 and 17-20 are pending.
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`Information Disclosure Statements and Power of Attorney
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`The information disclosure statement (IDS) submitted on November 6, 2018, was filed after the
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`mailing date of the Office Action on August 3, 2018. The submission is in compliance with the provisions
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`of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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`Furthermore, the IDS filed August 1, 2018, has been received and also considered.
`
`It was not considered
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`before because the Office Action mailed on August 3, 3018, was actually prepared beforethe filing of
`
`the IDS of August 1, 2018, but had not been mailed yet; so the Examiner was not awareofthe filing of
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`an IDS on August 1, 2018, therefore. Likewise, the Power of Attorney filed August 3, 2018, was not
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`before the Examiner at that time.
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`It is acknowledged, however, herein as being received and entered.
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`Response to Amendmentof November 2, 2018
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`The amendment filed November 2, 2018, has been received and entered. Thus, claims 1-6, 8-15
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`and 17-20 are presented for reconsideration on the merits. Claims 7 and 16 are canceled by the
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`amendment filed November 2, 2018. Applicants’ amendments and arguments have overcome the
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`objection to the claims and the rejections under 35 USC 112. However, the rejection under 35 USC 103
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`has been maintained for reasons that follow.
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`Claim Rejections - 35 USC § 103
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
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`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
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`basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and
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`the rationale supporting the rejection, would be the same under eitherstatus.
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`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 3
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`The following is a quotation of pre-AlA 35 U.S.C. 103(a) which forms the basis for all obviousness
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`rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102, if the differences between the subject matter sought to be patented and the
`prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinaryskill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966),
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`that are applied for establishing a background for determining obviousness under pre-AlA 35 U.S.C.
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`103(a) are summarized as follows:
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`1. Determining the scope and contentsofthe prior art.
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`2. Ascertaining the differences between the prior art and the claims at issue.
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`3. Resolving the level of ordinary skill in the pertinent art.
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`4. Considering objective evidence present in the application indicating obviousness or
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`nonobviousness.
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`This application currently names joint inventors. In considering patentability of the claims under
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`pre-AlA 35 U.S.C. 103(a), the examiner presumesthat the subject matter of the various claims was
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`commonly ownedat the time any inventions covered therein were made absent any evidence to the
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`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
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`invention dates of each claim that was not commonly ownedat the time a later invention was made in
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`orderfor the examiner to consider the applicability of pre-AlA 35 U.S.C. 103(c) and potential pre-AlA 35
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`U.S.C. 102(e), (f) or (g) prior art under pre-AlA 35 U.S.C. 103(a).
`
`Claims 1-6, 8-15 and 17-20 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable
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`over WO 2003/011873 to Sampalis, in view of USP 4133077 and Fricke et al references,all cited on
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`enclosed PTO-1449 Form and 2006/0177486A1 to Bruheim et al as cited on enclosed PTO-892 Form.
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`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 4
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`Regarding claims 1 and 14, a method of production ofkrill oil comprising obtaining a krill
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`oil comprising obtaining a krill meal produced by a process comprising cooking and dryingfresh krill
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`and said krill meal has been stored for 1 to 36 months; and extractingkrill oil from the meal with an
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`ethanol solvent system, to provide krill oil with 30-60% phospholipids(PL) w/w ofsaid krill oil, about 1%
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`ethanol and astaxanthin esters. Sampalis teaches a phospholipid composition from krill, see page 25,
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`lines 4-10. Subsequent processing of the krill biomass providesfor krill oil, lines 15-26 and Table 1 at
`
`page 26, see lines 1-25. The processing includes ethanol system extraction, see page 31, lines 20-25. Krill
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`oil phospholipids is disclosed by Sampalis to contain high quantitites of fatty acids, see page 34, lines 3-
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`7, amountsof at least 40% w/w and 45 to 60% w/w,see page 52, lines 17 and 12 and
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`include phosphatidylcholine, page 52, line 23, and fatty acids, see page 52, line 28 and omega-3, see
`
`page 53, line 3, and astaxanthin esters, see page 54,line 21 and line 25. In addition, with regardtoall
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`claims 1-20 Bruheim et al (2006/0177486A1) do teach that marine phospholipids are well known to be
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`prepared by extracting the PLs from meal using ethanol, see page 8, col. 2, [0061], lines 1-25 and krill oil
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`is disclosed at page 8, col. 1, [0060], line 3. Hence clearly the prior art recognized thatkrill oil is
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`obtainable from meal via extraction using ethanol solvent systems.
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`Sampalis does not disclose obtaining a krill meal produced by a process comprising cooking
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`and drying fresh krill and said meal having been stored for 1 to 36 months and extraction therefrom
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`using ethanol system. However, regarding claims 1 and 14:
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`USP 4133077 to Janiewicz et al; and Fricke et al reference dated 1986 do disclose,
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`respectively, cooking fresh or defrosted krill and thatkrill can be stored for some months (e.g. so this
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`reads on at least 1 or more months) and then subjected to extraction using a solvent system, see USP
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`4133077, col. 1, lines 30-35 and the 1986 dated version ofFricke et al, col. 2, page 131, "Mat. And
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`Meth." Lines 1-12.
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`

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`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 5
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`Regarding claims 2 and 14, Sampalis further disclose that free fatty acids are present, see
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`page 28, lines 5-7, in an amount of less than 5%.
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`Regarding claims 3-4 and 17-18, Fricke et al dated 1984, at page 822, Table 1,
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`disclose composition ofkrill to contain phospholipids of lysophosphatidylcholine in amountsof less than
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`about 3%, and less than about 2%, see Table 1.
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`Regarding claims 5 and 19, Samplais disclose triglycerides are present in greater than 30%,
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`see table 5, which is well within the range of 20% to 50% as claimed.
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`Regarding claims 6-16 and 20, Sampalis disclose its composition to contain high quantitites
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`of fatty acids, see page 34, lines 3-7, amountsof at least 40% w/w and 45 to 60% w/w,see page 52,
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`lines 17 and 12 and include phosphatidylcholine, page 52, line 23, and fatty acids, see page 52, line 28
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`and omega-3, see page 53 and page 28,lines 1-15; and page 53 line 3, and astaxanthin esters, see page
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`54, line 21 and line 25 and page30,lines 1-7. Further, at page 35, lines 7, the composition is disclosed
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`by Sampalis to be encapsulated in a capsule. Although the specified amountof 0.2 to 10 grams is
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`not specified the amountis well within the purview of an ordinary artisan. Also a soft gel capsule is
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`well knownto those of ordinaryskill in the art and a matter of routine optimization of formulizing
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`a composition for oral administration. The krill is Euphasia superba as disclosed by Sampalis at page
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`25, line 8.
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`It would have been obvious to one of ordinaryskill in the art at the time the claimed
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`invention was made to provide for a krill meal which had been storedfor at least 1 month comprising
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`cooking and drying fresh Euphausia superbakrill to obtain the krill meal and then extractkrill oil from
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`the meal with ethanol solvent system to provide for krill oil comprising 30-60% PLs, less than 5% free
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`fatty acids 1% ethanol, and 100 mg/kg astaxanthin esters, becauseall of the cited prior art as discussed
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`above in combination disclose the process steps for production ofkrill oil composition.
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`

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`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 6
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`Each of the claim features are discussed and recognized as taught by the cited prior
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`art combination of references. It would have at least been obvious to try cooking and dryingkrill to
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`obtain krill mean and then extracting oil from the meal to provide krill oil as claimed herein. Each of
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`the constituent ingredients are well-known to be comprised bykrill oil extract.
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`The percentage amountsof fatty acids, free and omega-3, as well as PLs and other amounts
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`in mg/kg of astaxanthin exters and residual 1% ethanol would have been expected to be present ina
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`krill oil composition. Hence in the absence of unexpected results and persuasive evidence to contrary
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`the claims are rendered prima facie obvious over the combination of cited prior art discussed supra.
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`Response to Arguments
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`Applicant's argumentsfiled November 2, 2018, have been fully considered but they are not
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`persuasive. The argumentthat the whole frozen krill is not the claimed krill meal is noted. However, the
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`claimed krill meal which is stored from 1 to 36 months doesread on thekrill samples of Fricke 1986
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`reference because the claims do not omit freeze storing of the krill samples which includes at least one
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`monthof frozen storage. The claims do not specify what form of storage is used for the krill meal.
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`Therefore, frozen storage is not omitted from the claims. Bruheim et al do teach at [0037], krill meal of
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`which phospholipids are extracted therefrom, see lines 1-3. Therefore, to obtain krill oil phospholipids
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`from krill meal is a matter of routine optimization by one ofskill in the art. To store the krill meal ina
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`frozen state before extracting the oil is also suggested by the cited prior art because storing whole krill
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`freshly caught is well known.
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`Janiewisc teaches storing the krill meat paste into frozen blocks which occurs after obtaining
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`the krill meat paste from fresh krill. Therefore, to provide a stored krill meal as a frozen material for
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`extraction of the oil therefrom later is an obvious modification of the cited prior art. Again the instant
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`claims do not omit a krill meal that has been stored (e.g. frozen) for 1 to 36 months. Since a material
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`

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`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 7
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`that is frozen is considered stored and would have been expected by oneofskill in the art to stay fresh
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`in this stored form for at least a month (e.g. food items stored in the freezer).
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`Also, the instant claims do not indicate any properties of quality krill oil.
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`In addition the cited
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`prior art clearly recognized at the time of the claimed invention was made that quality krill oil can be
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`obtained from krill meal. Hence to obtrain quality krill oil from frozen krill meal or frozen whole krill is a
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`matter of routine optimization by one of ordinary skill in the art. To cook and dry whole fresh krill and
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`then freeze it is not unobvious to one ofskill in the art. The steps of cooking and drying whole fresh krill
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`is well known as recognized by the teachings Janiewicz et al; and Fricke et al. Again the use ofkrill meal
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`as recited by instant claims does not omit frozen krill meal.
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`The second argumentregarding instant claims directed to a krill oil having about 1% ethanol is
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`noted. While Applicants arguments appear to focus on the teachings of Sampalis and Fricke using an
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`ethanol in a solvent mixture. The attention should be on that of Bruheim et al, which is interestingly
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`one of the common inventors of the instant case, wherein phospholipids are extract from fish or krill
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`meal using ethanol, note [0064], lines 11-12. Therefore, it would have been an expected successful
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`result of using the same solvent, ethanol, on the same material or similar source material. One of skill in
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`the art would have expected the same or about the same amountof ethanol (e.g. about 1% ethanol) in
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`the extracted oil as claimed herein. The rejection is, therefore, maintained for reasons of record and for
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`those discussed above.
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`THIS ACTION IS MADEFINAL. Applicant is reminded of the extension of time policy as set forth
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`in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
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`the mailing date of this action.
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`In the eventa first reply is filed within TWO MONTHS ofthe mailing date
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`of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shortened statutory period, then the shortened statutory period will expire on the date the advisory
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`

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`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 8
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`action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing
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`date of the advisory action.
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`In no event, however, will the statutory period for reply expire later than
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`SIX MONTHS from the mailing date of this final action.
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`All claims fail to be patentably distinguishable over the state of the art discussed above
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`and cited on the previously enclosed PTO-892 and/or PTO-1449. Therefore, the claims are properly
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`rejected.
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`The remaining referenceslisted on the enclosed PTO-892 and/or PTO-1449 arecited to
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`further show the state of the art.
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`No claims are allowed.
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`1.
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to DEBORAH K WARE whosetelephone numberis (571)272-0924. The examiner can
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`normally be reached on M-F 9:30am-6:00pm.
`
`Examiner interviewsare available via telephone, in-person, and video conferencing using a
`
`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
`
`the USPTO Automated Interview Request(AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`Renee Claytor can be reached on 571-272-8394. The fax phone numberfor the organization where this
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`application or proceeding is assigned is 571-273-8300.
`
`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-
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 9
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`direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic
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`CANADA)or 571-272-1000.
`
`DEBORAH K. WARE
`
`Primary Examiner
`Art Unit 1651
`
`/DEBORAH K WARE/
`Primary Examiner, Art Unit 1651
`
`