www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`15/976,130
`
`05/10/2018
`
`Inge Bruheim
`
`AKBM-14409/US-18/CON
`
`5089
`
`CasimirJones,$.C —
`
`Casimir Jones, S.C.
`2275 Deming WaySte 310
`Middleton, WISCONSIN 53562
`UNITED STATES OF AMERICA
`
`WARE,DEBORAH K
`
`PAPER NUMBER
`
`1651
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/03/2018
`
`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 be timely 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}.
`Anyreply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s)filed on
`CA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)L) This action is FINAL. 2b)JThis action is non-final.
`3)C) An election was made by the 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 merits is
`closed in accordance with the practice under Exparfe Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`6 7
`
`Disposition of Claims*
`1-20 is/are pendingin the application.
`5)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`[) Claim(s)__is/are allowed.
`Claim(s) 1-20 is/are rejected.
`() Claim(s) _ is/are objectedto.
`8)
`9) ( 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:/Awww.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)(_J 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 of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`—_c)LJ None ofthe:
`b)L) Some**
`a)() All
`Certified copies of the priority documents have been received.
`1.)
`Certified copies of the priority documents have been received in Application No.
`2.1)
`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 20180718
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`The present application is being examined under the pre-AlA first to invent provisions.
`
`Claims 1-20 are presented for consideration on the merits.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on May 10, 2018, was filed and received.
`
`The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information
`
`disclosure statement is being considered by the examiner.
`
`Priority to Related Subject Matter Incorporated by Reference
`
`Note that the Examiner recognizes the priority of the instant Application back to the date of
`
`March 28, 2007, since the subject matter as claimed herein is disclosed at least at pages 1-5, bridging
`
`pages 31-32, page 8 underneathsubtitle “A. Krill Processing”, and page9,all lines, page 10,all lines,
`
`page 12, lines 3-12, all of the disclosed Tables, etc. Furthermore, the process of preparing the krill oil as
`
`disclosed as far back as March 28, 2007, is using the same 20% ethanol concentration as disclosed
`
`instantly herein and will result in about 1% ethanol upon analysis of the krill oil; thus, the description of
`
`the instant claims notliterally disclosed are intrinsically disclosed because the same processas instantly
`
`claimed is disclosed, therefore. Hence, in the opinion of the Examiner the disclosure of the provisional
`
`60/920,483, does indeed provide for enablementof the subject matter as instantly filed and claimed
`
`herein.
`
`Claim Objections
`
`1.
`
`Claims 8-9 are objected to because of the following informalities: the phrase “at in an amount
`
`of” is awkwardly phrase and would bebetter in opinion of the Examiner to simply say —in an amountof--
`
`, etc. Appropriate correction is required.
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 3
`
`Claim Rejections - 35 USC § 112
`
`2.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or moreclaims particularly pointing out
`and distinctly claiming the subject matter which the inventor or a joint inventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`3.
`
`Claims 6, 11, 12, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
`
`paragraph,as being indefinite for failing to particularly point out and distinctly claim the subject matter
`
`whichthe inventor or a joint inventor, or for pre-AlA the applicant regards as the invention.
`
`4.
`
`Claims 6 and 20recite the limitation "in said composition" in each at line 2. Thereis insufficient
`
`antecedentbasis for this limitation in the claims because the term “composition” after “krill oil” in lines
`
`1 and 5/6,after “krill oil” is not recited in each of the claim 1/claim 14, respectively. Also, it may be
`
`necessary to insert --composition—after “krill oil” at line 1 in each of claims 2, 3, 4, 5, 6, 7, 8, 9, and 10-
`
`12 and 15-20.
`
`5.
`
`Claim 11 recites the limitation "wherein said encapsulating" in line 1. There is insufficient
`
`antecedentbasis for this limitation in the claim because the terminology is not recited in claim 8 but in
`
`claim 10. Likewise claim 12 recites “is encapsulated in said soft gel capsule” in lines 1-2. However, there
`
`is also insufficient antecedent basis for this limitation in the claim 12 because the terminologyis not
`
`recited in claim 9 but in claims 10-11.
`
`6.
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall
`contain a reference to a claim previously set forth and then specify a further limitation of the subject
`matter claimed. A claim in dependent form shall be construed to incorporate by referenceall the
`limitations of the claim to which it refers.
`
`The following is a quotation of pre-AlA 35 U.S.C. 112, fourth paragraph:
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 4
`
`Subject to the following paragraph [i.e., the fifth paragraph of pre-AlA 35 U.S.C. 112], a claim in
`dependentform shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate
`by referenceall the limitations of the claim to whichit refers.
`
`7.
`
`Claims 3-4, 7 and 16-18 are rejected under 35 U.S.C. 112(d) or pre-AlA 35 U.S.C. 112, 4th
`
`paragraph, as being of improper dependentform for failing to further limit the subject matter of the
`
`claim upon which it depends,or for failing to include all the limitations of the claim upon which it
`
`depends. Claims 2-3 are directed to a range of “less than about 3% lysophosphatidycholine” which is
`
`outside of the range of “ 30% to 60% phospholipids” as required by claim 1.
`
`In addition, claim 7 is
`
`directed to the phospholipid, phosphatidylcholine, but the phospholipid is comprised in a greater
`
`amountthan whatis claimed in claim 1 (e.g. at least 40%, which is a greater range than “30% to 60%).
`
`In addition, claim 16, has the same issue with respect to its recitation of a greater range being recited
`
`“at least 40% phosphatidylcholine” at line 1, because claim 14, requires “30% to 60% phospholipids”.
`
`The same is also true for claim 17-18 since “less than 3%” or “less than 2%”, respectively, of
`
`lysophosphatidylcholine is outside of the range of phospholipids of “30% to 60%” as required by claim
`
`14. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent
`
`form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent
`
`claim(s) complies with the statutory requirements.
`
`Claim Rejections - 35 USC § 103
`
`8.
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102
`
`and 103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory
`
`basis for the rejection will not be considered a new ground ofrejection if the prior art relied upon, and
`
`the rationale supporting the rejection, would be the same under either status.
`
`9.
`
`The following is a quotation of pre-AlA 35 U.S.C. 103(a) which forms the basis for all obviousness
`
`rejections set forth in this Office action:
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 5
`
`(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.
`
`10.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966),
`
`that are applied for establishing a background for determining obviousness under pre-AlA 35 U.S.C.
`
`103(a) are summarized as follows:
`
`1. Determining the scope and contents ofthe prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating obviousness or
`
`nonobviousness.
`
`11.
`
`This application currently names joint inventors. In considering patentability of the claims under
`
`pre-AlA 35 U.S.C. 103(a), the examiner presumesthat the subject matter of the various claims was
`
`commonly ownedat the time any inventions covered therein were made absentany evidence to the
`
`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
`
`invention dates of each claim that was not commonly ownedat the time a later invention was made in
`
`orderfor the examiner to consider the applicability of pre-AlA 35 U.S.C. 103(c) and potential pre-AlA 35
`
`U.S.C. 102(e), (f) or (g) prior art under pre-AlA 35 U.S.C. 103(a).
`
`12.
`
`Claims 1-20 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over WO
`
`2003/011873 to Sampalis, in view of USP 4133077 and Fricke et al references, all cited on enclosed PTO-
`
`1449 Form and 2006/0177486A1 to Bruheim et al as cited on enclosed PTO-892 Form.
`
`13.
`
`Regarding claims 1 and 14, a method of production ofkrill oil comprising obtaining a krill oil
`
`comprising obtaining a krill meal produced by a process comprising cooking and dryingfresh krill and
`
`said krill meal has been stored for 1 to 36 months; and extractingkrill oil from the meal with an ethanol
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 6
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`solvent system, to provide krill oil with 30-60% phospholipids(PL) w/w ofsaid krill oil, about 1% ethanol
`
`and astaxanthin esters. Sampalis teaches a phospholipid composition from krill, see page 25, lines 4-10.
`
`Subsequentprocessing 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 oil
`
`phospholipids is disclosed by Sampalis to contain high quantitites of fatty acids, see page 34, lines 3-7,
`
`amountsof at least 40% w/w and 45 to 60% w/w,see page 52, lines 17 and 12 and 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 regard to all claims 1-
`
`20 Bruheim et al (2006/0177486A1) do teach that marine phospholipids are well known to be prepared
`
`by extracting the PLs from meal using ethanol, see page 8, col. 2, [0061], lines 1-25 and krill oil is
`
`disclosed at page 8, col. 1, [0060], line 3. Hence clearly the prior art recognized that krill oil is obtainable
`
`from meal via extraction using ethanol solvent systems.
`
`14.
`
`Sampalis does not disclose obtaining a krill meal produced by a process comprising cooking and
`
`drying fresh krill and said meal having been stored for 1 to 36 months and extraction therefrom using
`
`ethanol system. However, regarding claims 1 and 14:
`
`15.
`
`USP 4133077 to Janiewicz et al; and Fricke et al reference dated 1986 do disclose, respectively,
`
`cooking fresh or defrosted krill and that krill can be stored for some months (e.g. so this reads on at
`
`least 1 or more months) and then subjected to extraction using a solvent system, see USP 4133077,col.
`
`1, lines 30-35 and the 1986 dated version of Fricke et al, col. 2, page 131, “Mat. And Meth.” Lines 1-12.
`
`16.
`
`Regarding claims 2 and 14, Sampalis further disclose that free fatty acids are present, see page
`
`28, lines 5-7, in an amount of less than 5%.
`
`17.
`
`Regarding claims 3-4 and 17-18, Fricke et al dated 1984, at page 822, Table 1, disclose
`
`composition ofkrill to contain phospholipids of lysophosphatidylcholine in amountsof less than about
`
`3%, and less than about 2%, see Table 1.
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 7
`
`18.
`
`Regarding claims 5 and 19, Samplais disclose triglycerides are present in greater than 30%, see
`
`table 5, which is well within the range of 20% to 50% as claimed.
`
`19.
`
`Regarding claims 6-16 and 20, Sampalis disclose its composition to contain high quantitites of
`
`fatty acids, see page 34,lines 3-7, amountsof at least 40% w/w and 45 to 60% w/w,see page 52,lines
`
`17 and 12 and include phosphatidylcholine, page 52, line 23, and fatty acids, see page 52, line 28 and
`
`omega-3, see page 53 and page28, lines 1-15; and page 53 line 3, and astaxanthin esters, see page 54,
`
`line 21 and line 25 and page 30,lines 1-7. Further, at page 35, lines 7, the composition is disclosed by
`
`Sampalis to be encapsulated in a capsule. Although the specified ammount of 0.2 to 10 grams is not
`
`specified the amountis well within the purview of an ordinary artisan. Also a soft gel capsule is well
`
`knownto those of ordinary skill in the art and a matter of routine optimization of formulizing a
`
`composition for oral administration. The krill is Euphasia superba as disclosed by Sampalis at page 25,
`
`line 8.
`
`20.
`
`It would have been obvious to one of ordinaryskill in the art at the time the claimed invention
`
`was made to provide for a krill meal which had been stored for at least 1 month comprising cooking and
`
`drying fresh Euphausia superbakrill to obtain the krill meal and then extract krill oil from the meal with
`
`ethanol solvent system to providefor krill oil comprising 30-60% PLs, less than 5% free fatty acids 1%
`
`ethanol, and 100 mg/kg astaxanthin esters, becauseall of the cited prior art as discussed abovein
`
`combination disclose the process steps for production ofkrill oil composition.
`
`21.
`
`Each of the claim features are discussed and recognized as taught by the cited prior art
`
`combination of references.
`
`It would have at least been obvious to try cooking and dryingkrill to obtain
`
`krill mean and then extracting oil from the meal to provide krill oil as claimed herein. Each of the
`
`constituent ingredients are well-known to be comprised bykrill oil extract.
`
`22.
`
`The percentage amountsoffatty acids, free and omega-3, as well as PLs and other amountsin
`
`mg/kg of astaxanthin exters and residual 1% ethanol would have been expected to be present ina krill
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 8
`
`oil composition. Hence in the absence of unexpected results and persuasive evidence to contrary the
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`claims are rendered prima facie obvious over the combination of cited prior art discussed supra.
`
`23.
`
`All claims fail to be patentably distinguishable over the state of the art discussed above and
`
`cited on the enclosed PTO-892 and/or PTO-1449. Therefore, the claims are properly rejected.
`
`24.
`
`The remaining referenceslisted on the enclosed PTO-892 and/or PTO-1449 are cited to further
`
`show the state of the art.
`
`25.
`
`No claims are allowed.
`
`26.
`
`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to DEBORAH K WARE whosetelephone numberis (571)272-0924. The examiner can
`
`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
`
`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-
`
`direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer
`
`Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR
`
`CANADA)or 571-272-1000.
`
`

`

`Application/Control Number: 15/976,130
`Art Unit: 1651
`
`Page 9
`
`DEBORAH K. WARE
`
`Primary Examiner
`Art Unit 1651
`
`27.
`
`/DEBORAH K WARE/
`Primary Examiner, Art Unit 1651
`
`