UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`16/023,146
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`06/29/2018
`
`Inge Bruheim
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`AKBM-14409/US-19/CON
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`7026
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`Ca51m1r Jones, SC.
`
`2275 Deming Way Ste 310
`Middleton, WI 53562
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`WARE” DEBORAHK
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`ART UNIT
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`1651
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`02/07/2019
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`docketing @ casimirjones .Com
`pto.correspondence@ casimirjones.com
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`PTOL-90A (Rev. 04/07)
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`

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`Off/09 A0170” Summary
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`Application No.
`16/023,146
`Examiner
`DEBORAH K WARE
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`Applicant(s)
`Bruheim et al.
`Art Unit
`1651
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`AIA Status
`No
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from 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, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
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`Status
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`1). Responsive to communication(s) filed on 04 December 2018.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] This action is non-final.
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`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s) fl is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabte. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
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`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).
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`Priority under 35 U.S.C. § 119
`12):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)D All
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`b)I:J Some”
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`c)C] None of the:
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`1.[:] Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) C] Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
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`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20190201
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`

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`Application/Control Number: 16/023,146
`Art Unit: 1651
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`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`The present application is being examined under the pre-AIA first to invent provisions.
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`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103
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`(or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the
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`rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale
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`supporting the rejection, would be the same under either status.
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`Response to Amendment
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`Original claims 1-6 are presented for reconsideration on the merits.
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`Information Disclosure Statement
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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 last office action on September 7, 2018. The submission is in compliance with the
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`provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
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`examiner.
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`Claim Rejections - 35 USC § 103
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`The following is a quotation of pre-AIA 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
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`as set forth in section 102, if the differences between the subject matter sought to be patented and the
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`prior art are such that the subject matter as a whole would have been obvious at the time the invention
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`was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability
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`shall not be negatived by the manner in which the invention was made.
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`

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`Application/Control Number: 16/023,146
`Art Unit: 1651
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`Page 3
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`This application currently names joint inventors. In considering patentability of the claims under
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`pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was
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`commonly owned at 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 owned at the time a later invention was made in
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`order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35
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`U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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`Claims 1-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sampalis (US
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`2004/0241249 A1), cited on enclosed PTO-1449 Form, in view of Manning et al (US 20060088574 A1),
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`cited on enclosed PTO-892 Form.
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`Regarding claims 1-2 and 4-6, Sampalis teaches, or at least suggests, method of treating a
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`subject including the step of administering to a human subject 0.2 to 10 grams/day krill oil as an
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`effective amount provided in a soft gel capsule, [0087], line 2 (e.g. gelules) and line 4., see [0034]-
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`[0084], all lines and particularly, [0034], lines 1-2; [0048]-[0052], lines 1-5; [0065], line 1, [0070]-[0074],
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`lines 1-6, [0056], lines line 1, and [0026], lines 1-2, as well as abstract, lines 46
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`Each capsule at [0087], lines 4-6, contain about 0.8 grams of oil and each subject (e.g. patient)
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`took 6 capsule per day, which is about 4.8 grams per day as a daily dose. Each of the amounts of ether
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`phospholipids and non-ether phospholipids of the krill oil are close to the percentage amounts of 3% to
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`10% and 27 to 50% or well within the skill of an ordinary artisan to optimize such amounts as desired to
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`obtain a desired result.
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`In addition, the triglycerides are disclosed to be less than 55% or less than 55g/100g of the krill
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`oil and astaxanthin is disclosed to be contained in greater than 20mg/100g which suggest amounts
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`much higher. Thus, one of skill in the art would have expected successful results of krill oil containing
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`greater than about 100 mg/kg of said krill oil, see [0065], line 1.
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`

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`Application/Control Number: 16/023,146
`Art Unit: 1651
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`Page 4
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`Each of the claimed features of claims 1-2 and 4-6 are taught, or at least suggested by the cited
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`disclosure of Sampalis. Furthermore, Sampalis teaches that the krill oil contains potassium, sodium and
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`calcium, [0072-0074], all lines.
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`Claims differ from Sampalis because the reference does not teach method of increasing muscle
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`mass wherein protein catabolism is decreased in the subject as required by instant claim 3.
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`Hence regarding this difference, Manning teach a nutritional supplement which contains krill oil,
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`[0076], lines 1 and 9; and various other ingredients to include potassium [0293-0294], all lines and
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`calcium, [0284], lines 1-3 and sodium [0290], all lines. Of which the nutritional supplement is important
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`for building muscle because of the presence of these ingredients. Krill oil contains these ingredients too.
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`It would have been obvious to one of ordinary skill in the art at the time the claimed invention
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`was made to administer krill oil composition as disclosed by Sampalis as a nutritional supplement for
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`increasing muscle mass as disclosed by Manning et al, with an expectation of successful results for
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`protein catabolism to be decreased in the subject.
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`This is because krill oil contains potassium, calcium and sodium, as disclosed by Sampalis, which
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`is further disclosed to be important for building muscle mass, as disclosed by Manning et al. Further, a
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`subject would, therefore, in response have been expected to successfully exhibit decreased protein
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`catabolism. Since krill oil provides nutritional benefits as disclosed by Manning et al.
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`Hence the combined effect of nutritional and therapeutic effects of krill oil as disclosed by the
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`cited prior art would have been expected to provide successful results for building muscle mass and
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`decreasing catabolism in a subject being administered the krill oil composition.
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`Each of the claimed features are either taught, or suggested, by the cited prior art combination
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`teachings of Sampalis in view of Manning et al.
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`One of skill in the art would have been motivated to provide a krill oil composition to increase
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`muscle mass in a subject while decreasing protein catabolism in the subject because krill oil contains
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`

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`Application/Control Number: 16/023,146
`Art Unit: 1651
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`Page 5
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`constituents which promote muscle building.
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`In the absence of unexpected successful results the claims
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`are rendered prima facie obvious over the cited prior art.
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`Response to Arguments
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`The argument that the Sampalis teaches administering at most 10 grams of krill oil per day is
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`noted. However, of that amount greater than 50 mg/100 g potassium, as disclosed by Sampalis, is
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`administered of which Manning has recognized to be sufficient for building muscle mass, [0293], all
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`lines. Furthermore, Applicants’ effective amount is 10 grams of krill oil per day. The dosage disclosed by
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`Sampalis would have been expected to provide successful results for building muscle mass as disclosed
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`by Manning. The argument that Manning teachings away is also noted but Manning also teachings that
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`omega-35 contained in Krill oil increase vascomotor function, see [0078]-[0079], all lines. Hence there is
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`sufficient teachings which support using krill oil supplements to support muscle function and growth.
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`Especially when taken in combination with Sampalis which teaches potassium in high amounts to be
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`present in krill oil and Manning teaches that muscle mass is increased, therefore. Also, Krill oil can by
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`purified to remove dangerous agents in order to use it for nutritional supplements and this is well-
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`recognized by those of skill in the art. The arguments are not deemed persuasive and the rejection is
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`sustained.
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`All claims fail to be patentably distinguishable over the state of the art discussed above and
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`cited on the previoulsy enclosed PTO-892 and/or PTO-1449. Therefore, the claims are properly rejected.
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`The remaining references listed on the enclosed PTO-892 and/or PTO-1449 are cited to further
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`show the state of the art.
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`No claims are allowed.
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`THIS ACTION IS MADE FINAL. 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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`

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`Application/Control Number: 16/023,146
`Art Unit: 1651
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`Page 6
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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 event a first reply is filed within TWO MONTHS of the 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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`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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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to DEBORAH K WARE whose telephone number is (571)272-0924. The examiner can
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`normally be reached on M-F 9:30am-6:00pm.
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`Examiner interviews are available via telephone, in-person, and video conferencing using a
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`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
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`the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this
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`application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent Application
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`Information Retrieval (PAIR) system. Status information for published applications may be obtained
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`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
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`through Private PAIR only. For more information about the PAIR system, see http://pair-
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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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`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer
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`

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`Application/Control Number: 16/023,146
`Art Unit: 1651
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`Page 7
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`Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR
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`CANADA) or 571-272-1000.
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`DEBORAH K. WARE
`
`Primary Examiner
`Art Unit 1651
`
`/DEBORAH K WARE/
`
`Primary Examiner, Art Unit 1651
`
`