UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF {MATION NO.
`
`95/001,774
`
`10/19/2011
`
`8,030,348
`
`AKBM—32174
`
`1897
`
`Sééiim LLP7590
`ATTN: Patent Group
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, DC 20004
`
`CAMPELL, BRUCE R
`
`3991
`
`MAIL DATE
`
`05/14/2013
`
`PAPER
`
`DELIVERY MODE
`
`PAPER
`
`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.
`
`000001
`PTOL—90A (Rev. 04/07)
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`Exhibit
`
`
`
`ENZYMOTEC - 1064
`
`000001
`
`

`
`Patent Under Reexamination
`
`
`
`Examiner
`
`Art Unit
`
`Transmittal of Communication to
`
`Control No.
`
`
`
`Third Party Requester
`Inter Partes Reexamination
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address. --
`
`Ij (THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS) —|
`
`J. Mitchell Jones, ESQ.
`Casmir Jones, S.C.
`2275 Deming Way
`Suite 310
`Middleton, Wisconsin 53562
`
`Enclosed is a copy of the latest communication from the United States Patent and Trademark Office
`in the above-identified reexamination prceeding. 37 CFR 1.903.
`
`Prior to the filing of a Notice of Appeal, each time the patent owner responds to this communication,
`the third party requester of the interpartes reexamination may once file written comments within a
`period of 30 days from the date of service of the patent owner's response. This 30-day time period is
`statutory (35 U.S.C. 314(b)(2)), and, as such, it cannot be extended. See also 37 CFR 1.947.
`
`If an ex parte reexamination has been merged with the interpartes reexamination, no responsive
`submission by any ex parte third party requester is permitted.
`
`All correspondence relating to this inter partes reexamination proceeding should be directed to the
`Central Reexamination Unit at the mail, FAX, or hand-carry addresses given at the end of the
`communication enclosed with this transmittal.
`
`U.S. Patent and Trademark Office
`PTOL-2070 (Rev. 07-04)
`
`000002
`
`Paper No. 20130306
`
`000002
`
`

`
`Control No.
`
`Patent Under Reexamination
`
`ACTION CLOSING PROSECUTION 95/001,774
`
`8,030,348
`
`
`
`BRUCE CAMPELL
`
`3991
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address. --
`
`Responsive to the communication(s) filed by:
`
`Patent Owner on 19 March 2012
`
`Third Party(ies) on 14 August, 2012
`
`Patent owner may once file a submission under 37 CFR 1.951 (a) within 1 month(s) from the mailing date of this
`Office action. Where a submission is filed, third party requester may file responsive comments under 37 CFR
`1.951 (b) within 30-days (not extendab|e- 35 U.S.C. § 314(b)(2)) from the date of service of the initial
`submission on the requester. Appeal cannot be taken from this action. Appeal can only be taken from a
`Right of Appeal Notice under 37 CFR 1.953.
`
`All correspondence relating to this inter partes reexamination proceeding should be directed to the Central
`Reexamination Unit at the mail, FAX, or hand-carry addresses given at the end of this Office action.
`
`PART I. THE FOLLOWING ATTACHMENT(S) ARE PART OF THIS ACTION:
`
`1. IZI Notice of References Cited by Examiner, PTO-892
`2. IX] Information Disclosure Citation, PTO/SB/08
`3.I:I
`
`PART II. SUMMARY OF ACTION:
`
`1a. IX] Claims 1-148 are subject to reexamination.
`
`1b. I:I Claims j are not subject to reexamination.
`2.
`I:I Claims j have been canceled.
`
`3.
`4.
`
`I:I Claims j are confirmed. [Unamended patent claims]
`I:I Claims j are patentable. [Amended or new claims]
`
`5.
`6.
`7.
`8
`9
`
`IX] Claims 1 are rejected.
`I:I Claims j are objected to.
`I:I are not acceptable.
`I:I are acceptable
`I:I The drawings filed on
`I:I The drawing correction request filed on
`is:
`El approved.
`|:I disapproved.
`I:I Acknowledgment is made of the claim for priority under 35 U.S.C. 119 (a)-(d). The certified copy has:
`I:I been received.
`I:I not been received.
`|:I been filed in Application/Control No j
`10. I:I Other j
`
`U.S. Patent and Trademark Office
`PTOL-2065 (08/06)
`
`000003
`
`Paper No. 20130306
`
`000003
`
`

`
`Application/Control Number: 95/001,774
`
`Page 2
`
`Art Unit: 3991
`
`Inter Partes Reexamination
`
`Action Closing Prosecution
`
`U.S. Patent 8,030,348 (the ‘348 patent) is subject to reexamination. A non-final
`
`Office action rejecting claims 1-21 was mailed December 19, 2011.
`
`Patent Owner filed a response on March 19, 2012. The response included claim
`
`amendments, new claims 22-148, and declarations by Fotini Sampalis, Earl L. White,
`
`Faustinus Yeboah, Fereidoon Shahidi, Chong M. Lee, Anthony P. Bimbo and Jacek
`
`Jaczynski.
`
`Requester filed comments and declarations by Bjorn Ole Haugsgierd
`
`(supplemental declaration), Thomas Gundersen (supplemental declaration), Richard B.
`
`van Breemen and Ivar Storm on April 18, 2012.
`
`A Notice Re Defective Paper was mailed August 3, 2012.
`
`Requester filed corrected comments on August 14, 2012.
`
`Status of the Claims
`
`Claims 1-21 and newly added claims 22-148 are subject to reexamination.
`
`Claims 10 and 15-18 have been amended.
`
`Documents Submitted by Requester
`
`The following documents were submitted by Requester.
`
`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)
`
`Japanese Laid Open Application 2909508, published August 28, 1990 by
`Maruyama et al.
`
`Araki et al., Positional distribution of fatty acids glycerolipids of the marine red
`alga, Porphyra yezoensis 28(5):761-766 (1987)
`
`Japanese Laid Open Publication 64-50890, published February 27, 1989 by
`Nishizawa et al.
`
`000004
`
`000004
`
`

`
`Application/Control Number: 95/001,774
`
`Page 3
`
`Art Unit: 3991
`
`FAO Fisheries Technical Paper 441, Chapter 8, Seaweeds Used as Human
`Food (2003)
`
`Eichberg, "Lecithin — lts Manufacture and Use in the Fat and Oil Industry,'' Oils
`and Soap 51-54, (1939)
`
`Johnson and Lucas, Comparison of Alternative Solvents for Oils Extraction,
`JAOCS 60(2):229—242 (1983)
`
`U.S. Pat. No. 4,714,571, issued December 22, 1987 to Tremblay et al.
`
`WO 97/39759, published October 30, 1997 by Stoll et al.
`
`Documents Cited by Examiner
`
`Influence of hazelnut oil phospholipids on the skin
`Masson et al. (1990)
`moisturizing effect of a cosmetic emulsion. International Journal of Cosmetic
`Science 12,243-251
`
`http://www.ewg.org/skindeep/product/40396/Glycolix_Elite_Treatment_Pads_10
`°/o25_°/3282010_formulation°/o29/#jumptohere [accessed 3/7/2013]
`(“Environmental Working Group”)
`
`Scope of the 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"). The independent claims
`
`read as follows:
`
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`Application/Control Number: 95/001,774
`
`Page 4
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`Art Unit: 3991
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`“Suitable for human consumption” Patent Owner argues that this limitation
`
`means that the claimed compositions must meet a "generally recognized as safe”
`
`0000012
`
`0000012
`
`

`
`Application/Control Number: 95/001,774
`
`Page 11
`
`Art Unit: 3991
`
`(GRAS) standard (response, pp. 45-46). This argument is not persuasive because it is
`
`not supported by anything in the specification or claims. Furthermore the GRAS
`
`designation merely provides an exemption from the testing normally required for FDA
`
`approval. The fact that the FDA may require test data for a composition does not mean
`
`that it is not suitable for human consumption. “Human consumption” is also not limited
`
`to oral administration of the claimed compositions, since the specification states that
`
`they may also be used for cosmetics (e.g., col. 20, lines 38-41).
`
`“Composition.” Patent Owner argues that the term “composition” is synonymous
`
`with “extract" (response, pp. 46-47). This argument is not persuasive in view of the ‘348
`
`patent specification, which states:
`
`‘‘In one aspect, the invention provides novel
`
`phospholipids” (col. 2, line 50). “According to a further aspect of the present invention
`
`there is provided a composition, comprising: (a) a phospholipid of the general formula
`
`(l)...and (b) a flavonoid of the general formula (II)’’ (col. 3, lines 3-45). “There is ali
`
`provided a phospholipid extract comprising the above noted phospholipids and
`
`flavonoid compound derived from a marine or aquatic biomass” (col. 4, lines 22-24,
`
`emphasis added). “Phospholipid production may be either synthetic or through
`
`extraction from natural tissues” (col. 5, lines 20-21). Clearly the specification does not
`
`limit the claimed invention to tissue extracts. Furthermore, the doctrine of claim
`
`differentiation suggests a broad interpretation of "composition." For example, claim 3
`
`recites that the composition of claim 1 comprises an additional lipid. This means that
`
`claim 1 also includes compositions which do not include additional lipids. Since an
`
`extract from a natural source would surely contain additional lipids, claim 1
`
`is not limited
`
`to compositions that are extracts. Similarly, claim 2 requires that the composition is
`
`derived from marine or aquatic biomass. Since the specification does not disclose
`
`extracts of any other starting material, claim 1 must include compositions other than
`
`extracts which are derived from marine or aquatic biomass.
`
`New claim 30 limits the composition to a form contained in a tablet or capsule.
`
`“Effective amount.” in claims such as claim 30, in which no intended use is
`
`recited, this term is taken to mean an amount effective for any purpose contemplated in
`
`the specification.
`
`0000013
`
`0000013
`
`

`
`Application/Control Number: 95/001,774
`
`Page 12
`
`Art Unit: 3991
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`Patent Owner has not offered any explanation of how the scope of claims reciting
`
`an “effective amount” differs from that of the other claims. Patent Owner obviously
`
`intends this term to differentiate over the prior art, but the specification does not disclose
`
`what constitutes an effective amount of the recited phospholipids. Patent Owner’s
`
`response does not provide any quantitative evidence regarding how much of these
`
`phospholipids are contained in the prior art extracts or in extracts made by the '348
`
`patent method, nor is there any evidence that "effective amounts" are known and
`
`recognized in the art. Therefore this term is not seen to limit the scope of the claims.
`
`For the same reasons, “conditions suitable for preserving an effective amount of a
`
`phospholipid...” does not affect the scope of the claims.
`
`It is also noted that it is
`
`redundant to include both of these terms in the same claim, as in claims 117 and 134,
`
`because an extract containing an effective amount of the recited phospholipids must
`
`have been made under conditions which preserved said effective amount of
`
`phospholipids.
`
`New claim 46, drawn to a krill oil extract, is narrower in scope than claim 1
`
`because it excludes compositions which are not extracts, as well as extracts that are not
`
`derived from krill.
`
`New claim 63 is similar to claim 46 except that, rather than reciting “comprising
`
`an effective amount,” it recites “extracted...under conditions suitable for preserving an
`
`effective amount.” Neither phrase distinguishes the invention from the prior art, as
`
`discussed above, and, to the extent that they are meaningful at all, both phrases have
`
`the same meaning. Moreover Patent Owner has not explained how claims 46 and 63
`
`differ in scope.
`
`it is suggested that Patent Owner cancel claim 63 and the following
`
`dependent claims.
`
`New claim 83 is similar to claim 46 except that, rather than reciting “a krill oil
`
`extract,” it recites “a composition comprising a solubilized lipid fraction from krill.” The
`
`portion of the specification cited as supporting the term “solubilized lipid fraction” (col.
`
`18, lines 54-55) indicates that it is lipid-containing solvent which has been separated
`
`from solid krill fragments without further processing. Every prior art reference that
`
`extracted lipids from krill first produced a solubilized lipid fraction, so this claim limitation
`
`0000014
`
`0000014
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`

`
`Application/Control Number: 95/001,774
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`Page 13
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`Art Unit: 3991
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`does not distinguish over the prior art of record. Patent Owner has not offered any
`
`explanation of the intended meaning of claim 83, nor separately argued for the
`
`patentability of a solubilized lipid fraction.
`
`It is suggested that Patent Owner cancel
`
`claim 83 and the following dependent claims.
`
`New claim 100 is similar to claim 46, but adds the further limitation that about
`
`50% of the total phospholipids in the extract carry an EPA or DHA group attached to
`
`phospholipids. This limitation is not supported by the specification (discussed further in
`
`rejection 15). Patent Owner has pointed to Table 2 for support but no correspondence
`
`to this limitation is found there. Patent Owner has not explained the significance of this
`
`limitation or how it might distinguish the claims from the prior art.
`
`It is suggested that
`
`Patent Owner cancel claim 100 and the following dependent claims.
`
`New claim 117 is similar to claim 46, but includes a conglomeration of the
`
`limitations found in other new claims: “comprising a solubilized lipid fraction” while still
`
`“suitable for human consumption,” "comprises an effective amount” while obviously
`
`“extracted...under conditions suitable for preserving an effective amount,” and having
`
`about 50% of total phospholipids carrying DHA or EPA. Patent Owner has not
`
`explained how this combination of limitations distinguishes over the prior art.
`
`It is
`
`suggested that Patent Owner cancel claim 117 and the following dependent claims.
`
`New claim 134 is similar to claim 117, with the further limitation that extraction
`
`solvent is removed without heating. This recitation appears to be duplicative of the
`
`“extracted...under conditions suitable for preserving an effective amount” limitation
`
`because Patent Owner has not identified any condition used in the prior art other than
`
`heating. Patent Owner has not explained why this claim differs in scope from claim 117.
`
`It is suggested that Patent Owner cancel claim 134 and the following dependent claims.
`
`35 i.»’.$.C. § H2
`
`The following is a quotation of 35 U.S.C. 112 (pre—AlA), first paragraph:
`
`The specification shall contain a written description of the invention, and of the manner
`and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly
`
`0000015
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`Application/Control Number: 95/001,774
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`Page 14
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`Art Unit: 3991
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`connected, to make and use the same and shall set forth the best mode contemplated
`by the inventor of carrying out his invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre—AlA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out and
`distinctly claiming the subject matter which the applicant regards as his invention.
`
`35 U.S.C. §§ 102 and 103
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a) the invention was known or used by others in this country, or patented or described in a printed
`publication in this or a foreign country, before the invention thereof by the applicant for a patent.
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in
`the United States.
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, 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 ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`In considering patentability of
`This application currently names joint inventors.
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
`the various claims was commonly owned at the time any inventions covered therein
`were made absent any 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 owned at the time a later invention was made in order for the examiner to
`consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
`prior art under 35 U.S.C. 103(a).
`
`Summary of Rejections
`
`0000016
`
`0000016
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`

`
`Application/Control Number: 95/001,774
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`Page 15
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`Art Unit: 3991
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`Numbering of rejections has been maintained from the previous Office action. There
`
`are no rejections numbered 9 or 10 (the previous Office action had 8 rejections and
`
`Requester numbered its proposed new rejections starting at 1 1).
`
`Proposed by Reguester and Adopted
`
`1. Claims 1-13 and 19-21 are rejected under 35 U.S.C. 102(b) as anticipated by
`
`Beaudoin I as evidenced by the (first) Haugsgjerd and (first) Gundersen declarations.
`
`2. Claims 1-13 and 19-21 are rejected under 35 U.S.C. 102(b) as anticipated by
`
`Beaudoin II as evidenced by the (first) Haugsgjerd and (first) Gundersen declarations
`
`and Beaudoin l.
`
`3. Claims 1-5, 12, 13 and 19-21 are rejected under 35 U.S.C. 102(b) as being
`
`anticipated by Maruyama as evidenced by the (first) Haugsgjerd and (first) Gundersen
`
`declarations and Beaudoin l.
`
`4. Claims 1-4, 20 and 21 are rejected under 35 U.S.C. 102(b) as being
`
`anticipated by Araki as evidenced by the FAO Fisheries Technical Paper 441.
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`5. Claims 1-4 and 6-11 are rejected under 35 U.S.C. 102(b) as being anticipated
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`by Nishizawa.
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`6. Claim 14-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Beaudoin l (as evidenced by the Haugsgjerd and Gundersen declarations).
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`7. Claims 14-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Beaudoin II (as evidenced by the Haugsgjerd and Gundersen declarations and
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`Beaudoin l).
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`8. Claims 14-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Beaudoin II (as evidenced by the Haugsgjerd and Gundersen declarations and
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`Beaudoin l) in view of Maruyama and Nishizawa.
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`11. Claims 23, 26, 41, 56, 59, 64, 76, 93, 96, 110,113,127,130 and 134-148 are
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`rejected under 35 U.S.C. 112 (pre-AIA), first paragraph, as falling to comply with the
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`written description requirement.
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`12. Claims 30-148 are rejected under 35 U.S.C. 112 (pre-AIA), first paragraph,
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`as falling to comply with the written description requirement.
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`13. Claims 63-82 and 117-148 are rejected under 35 U.S.C. 112 (pre-AIA), first
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`paragraph, as failing to comply with the written description requirement.
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`15. Claims 38, 54, 72, 91 and 100-148 are rejected under 35 U.S.C. 112 (pre-
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`AIA), first paragraph, as failing to comply with the written description requirement.
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`19. Claims 30-148 are rejected under 35 U.S.C. 112 (pre-AIA), second
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`paragraph, as being indefinite for failing to particularly point out and distinctly claim the
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`subject matter which the applicant regards as the invention.
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`22. Claims 22, 23, 27- 29, 46-53, 56, 60-71, 77-90, 93 and 97-99 are rejected
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`under 35 U.S.C. 102(b) as anticipated by Beaudoin I as evidenced by the Haugsgjerd,
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`Gundersen, van Breemen and Storro declarations.
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`23. Claims 22, 23, 27- 29, 46-53, 56, 60-71, 77-90, 93 and 97-99 are rejected
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`under 35 U.S.C. 102(b) as anticipated by Beaudoin II as evidenced by Beaudoin I and
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`the Haugsgjerd, Gundersen, van Breemen and Storro declarations.
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`24. Claims 24-26, 30-45, 54, 55, 57-59, 72-76, 91, 92, 94-96 and 100-148 are
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`rejected under 35 U.S.C. 103(a) as being unpatentable over Beaudoin I in view of
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`WO97/39759 (Stoll) and U.S. Pat. No. 4,714,571 (Tremblay), and in further view of
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`Eichberg, Johnson and Patentee's admission that the 2011 White Declaration confirms
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`the presence of the claimed phospholipid species in the Beaudoin I extracts.
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`Proposed by Reguester and Not Adopted
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`14. Requester proposes that claims 27, 28, 42, 43, 60, 61, 77, 78, 97, 98, 114,
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`115, 131, 132, 146 and 147 should be rejected under 35 U.S.C. 112 (pre-AIA), first
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`paragraph, as failing to comply with the written description requirement.
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`16. Requester proposes that claims 37, 53, 71, 90, 107, 124 and 141 should be
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`rejected under 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the
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`written description requirement.
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`17. Requester proposes that claims 15-18 should be rejected under 35
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`U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description
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`requirement.
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`18. Requester proposes that claims 15-18 should be rejected under 35
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`U.S.C. 112 (pre-AIA), second paragraph, as indefinite.
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`20. Requester proposes that claims 30-148 should be rejected under 35
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`U.S.C. 112 (pre—AlA), first paragraph, as failing to comply with the enablement
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`requirement.
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`21. Requester proposes that claims 30-148 should be rejected under 35
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`U.S.C. 112 (pre—AlA), first paragraph, as failing to comply with the enablement
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`requirement
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`Examiner’s Rejections and Objection
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`25. Claims 22, 23, 26, 40, 41 and 46-148 are rejected under 35 U.S.C. 112 (pre-
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`AIA), first paragraph, because the best mode contemplated by the inventor has not
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`been disclosed.
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`26. Claims 129 and 145 are rejected under 35 U.S.C. 112 (pre-AIA), second
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`paragraph, as being indefinite for failing to particularly point out and distinctly claim the
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`subject matter which the applicant regards as the invention.
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`27. Claims 108, 125 and 142 are objected to because they fail to further limit
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`claims 100, 117 and 134, respectively.
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`Evidence Submitted by Patent Owner
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`Yeboah declaration. Dr. Yeboah addresses several issues in his declaration.
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`First, Yeboah points out the first Gundersen declaration (filed with Request October 4,
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`2011) contains erroneous data. Specifically, the Gundersen declaration provides
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`identical chromatograms for the samples designated P308-8, P308-9, P308-10, P308-
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`11 and P308-12. This is acknowledged and explained by Dr. Gundersen in his
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`supplemental declaration, which is discussed below. Yeboah concludes that
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`Gundersen was “rushed.”
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`Yeboah argues that Gundersen did not run “solvent only” negative controls
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`between chromatographic runs. This issue is also addressed in the supplemental
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`Gundersen declaration.
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`Yeboah points out that some chromatographic peaks in Gundersen’s data are
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`poorly resolved.
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`it is true that the krill oil extract is a very complex mixture, but
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`Gundersen ran positive controls (standards) of the phospholipids in question, and the
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`data show peaks having the same retention times and molecular fragment sizes as the
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`standards. Yeboah does not explain why one would not conclude that those peaks
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`contain the phospholipids in question, especially in view of the fact that there are no
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`other peaks containing fragments of that size.
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`Yeboah concludes that no weight at all should be given to the Gundersen
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`declaration (11 23).
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`Yeboah next turns to the declaration of Earl White which was filed May 31, 2011
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`during prosecution of the ‘348 patent (application 10/485,094). Yeboah describes errors
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`in the White declaration and opines that these errors are not important.
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`(This does not
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`appear to be the same standard applied to the Gundersen declaration.) The White
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`declaration includes Figure 10, which shows the presence of the claimed phospholipids
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`in a “previous Beaudoin oil.” Yeboah argues that this figure should be disregarded
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`because this “previous Beaudoin oil" was not made according to the Beaudoin
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`procedure, citing a protocol for production of krill oil provided as appendix D to the
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`Yeboah declaration. This argument is not persuasive because Yeboah does not have
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`personal knowledge of how the "previous Beaudoin oil," or any other sample analyzed
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`by White, was prepared. There is no evidence (in this or any other declaration) that the
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`protocol in appendix D was used to produce the “previous” oil. There is no description
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`in the White declaration of how any samples he analyzed were prepared. Because
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`there is no basis for Dr. Yeboah to know that the sample analyzed in White's figure 10
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`was prepared by a different method than the other samples analyzed by White, this
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`portion of the declaration is not accorded any weight.
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`Finally, Yeboah opines that White’s data shows that there is little or none of the
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`claimed phospholipids in the samples White analyzed. This opinion is given little weight
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`in view of the Elliott reference (provided as appendix B to the Yeboah declaration),
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`which states, "For absolute quantitation, however, the absolute amount of material in
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`the reference sample must be known. This means that standard known amounts of the
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`target...must be available for all of the targeted analytes. This is not a trivial
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`requirement...” (p. 1637, col. 1). Since White did not use a reference standard
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`(discussed further below), it would appear that accurate quantitation of the species in
`
`the samples he analyzed is not possible.
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`Shahidi declaration. Dr. Shahidi argues that the claims are limited to a
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`biologically effective amount of an extract containing the recited phospholipids. This
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`argument is not persuasive. See the explanation given above of how the claims are
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`interpreted.
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`Shahidi opines that the White declaration of May 31, 2011 (filed in 10/485,094)
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`shows that krill oil produced by the method of Beaudoin I does not contain a biologically
`
`effective amount of the recited lipids. This is not found persuasive because 1) there is
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`no declaration evidence regarding how the samples analyzed by White were prepared,
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`2) White did not establish what the limits of detection were for his analysis, and 3)
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`Shahidi does not state what constitutes a biologically effective amount of the
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`phospholipids.
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`in particular, Shahidi states that an oil containing 0.1% to 1% of the
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`claimed phospholipids would not be biologically effective (11 22). The claimed
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`compositions can be used as skin moisturizers (col. 20, lines 38-41). Masson showed
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`that hazelnut oil containing 224 or 286 ppm (about 0.025%) phospholipids was
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`biologically effective when incorporated into a moisturizing emulsion (entire document,
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`see Fig. 2). While hazelnut oil is not expected to contain the same phospholipid species
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`as krill oil, Masson shows that phospholipids can be biologically effective at levels lower
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`than Shahidi concedes might be in krill oil prepared by the Beaudoin method.
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`White declaration. This supplemental declaration by Dr. White is in response to
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`Requester’s criticism of the White declaration of May 31, 2011. The Request argued
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`that White did not use proper controls when conducting his analysis of krill oil samples
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`provided by Patent Owner.
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`In the supplemental declaration, White affirms that he ran
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`positive and negative controls while conducting the aforementioned analysis.
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`Lee declaration. Dr. Lee states that scientists commonly heat lipid extracts to
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`remove extraction solvents, especially before quantitative analysis of the recovered
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`lipids. Lee points out that krill extracts were heated in Beaudoin I. Dr. Lee further
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`discusses the procedures used in several other references. The other references have
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`no probative value with regard to the procedure disclosed in Beaudoin l. Lee also
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`opines that the amount of heating disclosed in Beaudoin ll would be insufficient to
`
`remove all solvents and water from the krill extract. With regard to the Maruyama
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`reference, Lee admits that there is not enough information provided to discern how
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`solvent was removed from krill extract, but speculates that the extract may have been
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`heated.
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`Dr. Lee opines that hydrolysis of phospholipids may have occurred upon heating
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`of the krill extracts disclosed by Beaudoin l, Beaudoin II and Maruyama. This opinion is
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`based on three references from the scientific literature. This line of reasoning is not
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`found persuasive because Lee's references disclose procedures markedly different from
`
`those used by Beaudoin and Maruyama.
`
`in Medina (Lee appendix E), tuna meat was
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`steamed for 90 min, sterilized at 110 °C for 55 min, then stored for 3 months before
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`being analyzed for free fatty acid content. This is clearly different from heating almost
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`pure krill oil at 125 °C for 15 min (Beaudoin l). Moreover Medina apparently only
`
`analyzed triacylglycerols, not phospholipids. Grit (Lee appendix F) studied
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`phosphatidylcholine hydrolysis in aqueous dispersions of liposomes. This study used
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`dispersions containing about 30 mM phosphatidylcholine, which is obviously a much
`
`higher proportion of water to phospholipid than is present in the extracts of Beaudoin
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`and Maruyama. Grit found that over 50% of phosphatidylcholine remained intact after
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`200 hr at 82 °C (Fig. 3). This does not support Lee’s conclusion that phospholipids in
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`krill extract would be significantly degraded by a 15 min treatment at 125 °C. Herman
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`(Lee appendix G) studied the formation of free fatty acids (measured by pH change)
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`when phospholipid stabilized triglyceride emulsions were heated. This study also used
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`a material having a much higher proportion of water to phospholipid than is present in
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`the extracts of Beaudoin and Maruyama.
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`It is also not clear how much heat was applied
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`to the samples; samples were autoclaved