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`amount for use in a skin moisturizer, nutraceutical composition or other product
`
`envisioned by the specification.
`
`Examiner’s Rejections and Objections
`
`25. Claims 22, 23, 26, 40, 41 and 46-148 are rejected under 35 U.S.C. 112 (pre-
`
`AlA), first paragraph, because the best mode contemplated by the inventor has not
`
`been disclosed. Evidence of concealment of the best mode is based upon the Sampalis
`
`declaration.
`
`The claims are drawn to a krill oil extract containing an “effective amount” of
`
`phospholipids having two EPA and/or DHA groups. Patent Owner has argued that the
`
`prior art krill extracts do not contain an effective amount of the claimed phospholipids
`
`due to high temperatures used to evaporate extraction solvents.
`
`If Patent Owner’s
`
`theory is correct, then removal of solvent at low temperature is clearly the best mode for
`
`practicing the invention and has not been disclosed in the specification.
`
`A proper best mode analysis has two components: Determine (A) whether at the
`
`time the application was filed, the inventor knew of a mode of practicing the claimed
`
`invention that the inventor considered to be better than any other and (B) whether the
`
`disclosure is adequate to enable one skilled in the art to practice the best mode. See
`
`MPEP 2165.03.
`
`The Sampalis declaration clearly indicates that the inventor considered solvent
`
`evaporation at temperatures below 5 °C to be critical for producing an extract with
`
`“effective amounts” of the claimed phospholipids (1111 8-11), satisfying requirement (A).
`
`With regard to requirement (B), the specification does not enable the skilled artisan to
`
`practice the best mode. This conclusion is based on the state of the art and the
`
`absence of guidance in the specification. The expert declarants for Requester and
`
`Patent Owner agree that it was standard practice to remove solvents from oil extracts
`
`using temperatures substantially higher than 5 °C. The specification directs the reader
`
`to Beaudoin I for the extraction procedure (col. 18). The only deviations from the
`
`Beaudoin I procedure are the proportions of solvents used for extraction. The
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`specification states that acetone is removed by flash evaporation or spray drying (col.
`
`18, lines 58-59) and ethanol is simply “evaporated” (col. 18, lines 63-64). No mention is
`
`made of solvent evaporation temperature. Since the Sampalis declaration states that
`
`the key to the invention was changing the Beaudoin l method, the specification, by
`
`directing to follow the Beaudoin I method, actually teaches away from the best mode.
`
`Therefore the disclosure does not enable one skilled in the art to practice the best
`
`mode.
`
`26. Claims 129 and 145 are rejected under 35 U.S.C. 112 (pre-AIA), second
`
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the
`
`subject matter which the applicant regards as the invention.
`
`Claims 129 and 145 are indefinite in their recitation of “composition,” which lacks
`
`antecedent in the claims from which they depend.
`
`27. Claims 108, 125 and 142 are objected to because they fail to further limit
`
`claims 100, 117 and 134, respectively.
`
`Response to Patent Owner’s Arguments
`
`Patent Owner’s response, Requester’s comments and all declarations submitted
`
`by both parties have been considered.
`
`Rejections 1 and 22
`
`Patent Owner argues (response, pp. 34-40) that Haugsgjerd and Gundersen do
`
`not show that extracts made by the Beaudoin l procedure contain the claimed
`
`phospholipids. This argument is based on the declarations submitted with the
`
`response, which have been analyzed and not found persuasive for the reasons stated
`
`above. With regard to the alleged errors made by Haugsgjerd in producing the extracts,
`
`Haugsgjerd repeated the extractions as “instructed” by Patent Owner’s experts and van
`
`Breemen definitively showed that the extracts contained the claimed phospholipids.
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`Patent Owner argues that Beaudoin I heated the extracts to remove solvents and
`
`further argues that Beaudoin I discloses solvent residues in excess of what is suitable
`
`for human consumption (response, pp. 41-44 and 44-46, respectively). These two lines
`
`of argument are not consistent; it is not clear how both can be correct.
`
`It may be that
`
`Beaudoin I removed an aliquot of extract and heated it to 125 °C for 15 minutes prior to
`
`analysis, as suggested in the Storro declaration (11 27). But Patent Owner’s position
`
`seems to be that Beaudoin I heated the extract to 125 °C to remove “traces of solvents,”
`
`yet the extracts still contained large amounts of solvent.
`
`With regard to heating, Patent Owner’s arguments are not persuasive. As
`
`discussed at length above, Patent Owner’s declarants rely on studies of very different
`
`compositions subjected to very different conditions to support the theory that heating
`
`destroys the claimed phospholipids. The only direct experimental evidence is provided
`
`by Requester's declarants, who conclude that the claimed phospholipids are present in
`
`the extract regardless of heat treatment (e.g. van Breemen, 1] 15). With regard to
`
`solvent residue, as discussed above, 1) the residue was not analyzed, so the chemical
`
`composition thereof is a matter of speculation; 2) solvents were removed at 125 °C, so
`
`at least the portion of the composition that was heated to this temperature should be
`
`free of solvents; 3) ethanol is suitable for human consumption; 4) acetone is suitable for
`
`use in cosmetic compositions; 5) the GRAS data for other products says nothing about
`
`whether the Beaudoin extract is suitable for human consumption; 6) Beaudoin I teaches
`
`how to remove solvents and 7) Beaudoin actually consumed his composition.
`
`Requester notes that solvent extraction has been used for decades to obtain
`
`phospholipids such as lecithin from biological material, and that solvents are routinely
`
`removed under reduced pressure to yield products suitable for human consumption
`
`(see Storro 1] 24). This is (indirectly) supported by the documents submitted with the
`
`Bimbo declaration. For example, the GRAS notice for Enzymotec (Bimbo appendix K)
`
`states, “The raw material to be extracted, krill meal, is a biomass composed of lipids,
`
`sugars and proteins. By using a solvent extraction process, the proteins and free sugars
`
`are removed so that only lipids are left. Various solvents may be used for the extraction
`
`process, all of which are of food-grade quality and are used and removed from the
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`product in accordance with current good manufacturing practice” (p. 10). Similarly, the
`
`GRAS notice for Aker Biomarine (Bimbo appendix I) simply states that krill meal is
`
`subjected to ethanol extraction and the “ethanol-oil solution is then concentrated by
`
`evaporation and stored” (p. 6). The fact that regulatory agencies do not require more
`
`detailed information than “solvents are removed” or “concentrated by evaporation”
`
`supports the notion that these methods are well known in the art. Therefore it is
`
`concluded that, when Beaudoin I states that the krill oil extract is intended as a dietary
`
`supplement (p. 1) and the protocol for its production includes solvent “evaporation under
`
`reduced pressure” (Table 19), one skilled in the art would know how to remove
`
`substantially all solvent to yield a product suitable for human consumption.
`
`Patent Owner argues that krill meat does not anticipate the claims because the
`
`claims are limited to an extract (response, pp. 46-47). For claims drawn to a
`
`“composition” rather than an extract, this argument is not persuasive for the reasons
`
`discussed above. The specification describes a “composition” as well as an “extract.”
`
`The claimed phospholipids are natural products. Therefore a composition comprising
`
`krill lipids is anticipated by krill meat, just as a composition comprising vitamin C is
`
`anticipated by orange juice.
`
`Patent Owner argues that the Beaudoin I extracts contain a “de minimis” amount
`
`of the claimed phospholipids (response, pp. 47-52). This argument is not persuasive for
`
`the reasons discussed at length above.
`
`In brief, 1) there is no quantitative data
`
`regarding the level of the phospholipids in the Beaudoin l extract or in the ‘348 patent
`
`extract. There is no basis for concluding that the ‘348 patent extract contained more of
`
`these lipid species. 2) There is no evidence regarding what constitutes an “effective
`
`amount” of the claimed lipids, for any intended use contemplated in the specification. 3)
`
`It is not known what White’s detection limits for the claimed species were, because he
`
`did not use a reference standard for those species. 4) None of Patent Owner’s
`
`evidence distinguishes between the biological effects of the claimed phospholipids and
`
`the effects of other lipids in the extract, such as phospholipids having a single DHA or
`
`EPA group, which are also biologically active. Patent Owner’s declarants also do not
`
`discuss the effective levels of phospholipids for cosmetic and nutraceutical
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`compositions as contemplated in the specification (and encompassed by the claims).
`
`Moreover, Patent Owner's reliance on In re Seaborg is misplaced.
`
`In that case, a
`
`radioactive isotope was present at a level of 6.15 ng in 88,000 kg, or
`
`0.000000000000007°/o. Since Dr. Shahidi opines (11 22) that the “Beaudoin extract”
`
`analyzed by White contains 0.1 to 1.0% of the claimed phospholipids (about a
`
`quadrillion times higher than in Seaborg), the instant case clearly does not present the
`
`same fact situation.
`
`Reiections 2 and 23
`
`Patent Owner traverses the rejections over Beaudoin II on essentially the same
`
`grounds as rejection 1 (response, pp. 52-57), and these arguments are not persuasive
`
`for the same reasons noted above. Patent Owner further argues that the extract of
`
`Beaudoin ll would contain even more solvent because it was heated to only 60 or 70 °C
`
`rather than 125 °C. This argument is not persuasive because, like Beaudoin l,
`
`Beaudoin ll directs the skilled artisan to remove solvents by “evaporation under reduced
`
`pressure” (Table 11) and the skilled artisan knew how to remove substantially all solvent
`
`residue from food products, such procedures being routinely used in the art for
`
`decades.
`
`Reiection 3
`
`Patent Owner’s traversal (response, pp. 57-63) is based on the premise that the
`
`claims are drawn to an extract. This argument is not persuasive because the claims are
`
`drawn to a composition, as discussed above.
`
`Patent Owner argues that Maruyama does not disclose how ethanol was
`
`removed from the krill lipid extract, leading to speculation that either the extract was
`
`heated (thereby destroying phospholipids) or that it contained so much residual ethanol
`
`that it was not suitable for human consumption. These arguments are not persuasive.
`
`In working example 1, Maruyama obtained 239 g phosphatidylcholine and 45 g
`
`phosphatidylethanolamine from 2 kg dried krill (equivalent to 18.2 kg fresh krill, since 20
`
`kg fresh krill yielded 2.2 kg dried). Therefore these two classes of phospholipid made
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`up about 1.5% (by weight) of the fresh krill . Since these phospholipids made up about
`
`38% of the total lipids in the dried krill (Table 1 ; compare with 40% total phospholipids
`
`disclosed in ‘348 patent, Table 5), the total lipid content of the fresh krill can be
`
`calculated as about 3.9%. This is comparable to the values reported in Suzuki
`
`(provided with Request, see Table 1), which show crude fat ranging from about 0.5% to
`
`3.6%. Because the amount of phospholipids recovered is within the expected range, it
`
`is concluded that 1) Maruyama extracted the majority of the lipids from the krill and 2)
`
`the extraction and solvent removal procedure did not cause substantial hydrolysis of the
`
`phospholipids in the extract. And because Patent Owner does not deny that the
`
`claimed phospholipids naturally occur in krill and are readily extracted with ethanol and
`
`acetone, and Patent Owner has not presented any evidence or theory to suggest that
`
`o_nly the claimed phospholipids would be affected by the hypothesized degradation
`
`during solvent removal, it is also concluded that the extract of Maruyama contained the
`
`claimed phospholipids.
`
`With regard to excess ethanol rendering the extract unsuitable for human
`
`consumption, ethanol is suitable for human consumption both orally and topically as
`
`discussed above. Furthermore, Murayama’s purified phosphatidylcholine was
`
`consumed by a human 3 times daily for 6 weeks (working example 2). The
`
`chromatographically purified phosphatidylcholine and phosphatidylethanolamine are
`
`within the scope of claim 1. With regard to claim 3, Winther shows that either fraction
`
`would be expected to contain a complex mixture of species having different fatty acyl
`
`groups.
`
`Patent Owner’s argument that the reference is not enabling is not persuasive
`
`because the “Wands factors” have not been considered. All the evidence of record
`
`leads to the conclusion that the skilled artisan knew how to remove solvents from
`
`compositions intended for human consumption without detailed guidance. Patent
`
`Owner has not presented a convincing argument for why this would require undue
`
`experimentation.
`
`Patent Owner’s arguments regarding the credibility of the Gundersen declaration
`
`are not persuasive for the reasons discussed in detail above. Gundersen and van
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`Breemen each confirm, using analytical techniques much more rigorous than those
`
`used in the ‘348 patent itself, that extracts of krill contain the claimed phospholipids.
`
`The prior art used the same solvents as the ‘348 patent to extract the phospholipids and
`
`there is no evidence that the solvent removal procedures used in the prior art cause
`
`their destruction (in fact all the evidence of record leads to the opposite conclusion).
`
`The Office has presented a prima facie case of inherent anticipation and Patent Owner
`
`has not presented convincing evidence to the contrary.
`
`Reiection 4
`
`Patent Owner’s response (pp. 63-65) again argues that the claims are limited to
`
`extracts, which is not persuasive as noted above. Patent Owner further argues that
`
`Araki did not demonstrate the presence of the claimed phospholipids in Porphyra. This
`
`argument is not persuasive. Araki teaches that EPA makes up 60% of the total fatty
`
`acids in phosphatidylcholine of Porphyra (p. 762, 1] 1).
`
`If one position (either sn—1 or sn-
`
`2) is entirely occupied by EPA, that would account for only 50% of the fatty acids — the
`
`remainder of the EPA must be in the other position.
`
`If the EPA is evenly distributed
`
`between the two positions, at least 20% of the PC must be PC-EPA/EPA.
`
`It is
`
`mathematically impossible for a mixture of phosphatidylcholine species containing 60%
`
`EPA to n_o’t contain PC-EPA/EPA.
`
`Reiection 5
`
`Patent Owner again argues that the claims are limited to an extract, which
`
`remains unpersuasive. Moreover Nishizawa discloses an extract. Patent Owner
`
`argues that the extract of Nishizawa is made using toxic solvents which would render
`
`the extract unsuitable for human consumption. This argument is not persuasive
`
`because Nishizawa teaches that phospholipids can be extracted with any number of
`
`solvents, including ethanol (p. 842, col. 2). As discussed above, one skilled in the art
`
`knew how to use ethanol to extract from biological materials substances intended for
`
`human consumption and then remove the ethanol.
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`Patent Owner argues that Nishizawa does not disclose the presence of the
`
`claimed phospholipids. This is incorrect. Nishizawa clearly states that Figs. 1 and 2
`
`show the analysis of a chromatographic fraction containing PC-DHA/DHA. Figure 1
`
`shows that the most prevalent fatty acid present (by far) is DHA. Figure 2 shows that
`
`the predominant molecular ion is m/z 878, the same as reported by van Breemen (1j 13)
`
`for authentic PC-DHA/DHA standard.
`
`Rejections 6- 8
`
`Patent Owner traverses these rejections on the same grounds as rejections 1-3
`
`and 5. The rejections are maintained as Patent Owner’s arguments regarding the other
`
`rejections are not persuasive for the reasons set forth above.
`
`Conclusion
`
`Rejections 1-8 are maintained. New rejections 11-13, 15 and 22-24 are adopted.
`
`Proposed new rejections 14 and 16-21 are not adopted. New examiner’s rejections 25-
`
`26 and objection 27 are applied. Claims 1-148 are rejected.
`
`This is an ACTION CLOSING PROSECUTION (ACP); see MPEP § 2671.02.
`(1) Pursuant to 37 CFR 1.951 (a), the patent owner may once file written
`comments limited to the issues raised in the reexamination proceeding and/or present a
`proposed amendment to the claims which amendment will be subject to the criteria of
`37 CFR 1.116 as to whether it shall be entered and considered. Such comments and/or
`
`proposed amendments must be filed within a time period of 30 days or one month
`(whichever is longer) from the mailing date of this action. Where the patent owner files
`such comments and/or a proposed amendment, the third party requester may once file
`comments under 37 CFR 1.951 (b) responding to the patent owner’s submission within
`30 days from the date of service of the patent owner’s submission on the third party
`requester.
`(2) If the patent owner does not timely file comments and/or a proposed
`amendment pursuant to 37 CFR 1.951 (a), then the third party requester is precluded
`from filing comments under 37 CFR 1.951 (b).
`(3) Appeal cannot be taken from this action, since it is not a final Office action.
`
`Duty to Disclose
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`Page 57
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`The patent owner is reminded of the continuing responsibility under 37 CFR
`
`1.985(a) to apprise the Office of any litigation activity, or other prior or concurrent
`
`proceeding, involving U.S. Patent No. 8,030,348 throughout the course of this
`
`reexamination proceeding. The third party requester is also reminded of the ability to
`
`similarly apprise the Office of any such activity or proceeding throughout the course of
`
`this reexamination proceeding.
`
`Inter Partes Service of Papers
`
`After the filing of a request for reexamination by a third party requester, any
`
`document filed by either the patent owner or the third party requester must be served on
`
`the other party (or parties where two or more third party requester proceedings are
`
`merged) in the reexamination proceeding in the manner provided in 37 CFR 1.248. See
`
`37 CFR 1.903.
`
`Future Correspondence
`
`All correspondence relating to this inter partes reexamination proceeding should
`
`be directed as follows:
`
`By EFS:
`
`Registered users may submit via the electronic filing system EFS-Web at
`
`https://refs.uspto.gov/efiie/myportal/efsvregiste-red
`
`By U.S. Postal Service Mail to:
`
`Mail Stop Inter Partes Reexam
`ATTN: Central Reexamination Unit
`
`Commissioner for Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`/Bruce Campell/
`Patent Reexamination Specialist
`Central Reexamination Unit 3991
`
`0000059
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`Application/Control Number: 95/001,774
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`Page 58
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`Art Unit: 3991
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`/Sharon Turner/
`
`Patent Reexamination Specialist
`Central Reexamination Unit 3991
`
`/Deborah D Jones/
`
`Supervisory Patent Examiner, Art Unit 3991
`
`0000060
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`0000060
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`

`
`Notice of References Cited Examiner
`
`Application/Control No.
`
`95/001,774
`
`Applicant(s)/Patent Under
`Reexamination
`8 030 348
`Art Unit
`
`U.S. PATENT DOCUMENTS
`
`iviivi vvvvI
`Country Code Number Kind Code
`I2—‘
`II!2—‘
`I2—‘
`III2—‘
`I2—‘
`I2—‘
`
`*
`
`Document Number
`Date
`_
`_
`_
`Country COde_NUmber_Kind Code
`MM_YYYY
`Country
`Name
`Classification
`I
`
`FOREIGN PATENT DOCUMENTS
`
`I2—‘
`
`[accessed 3/7/2013]
`
`I
`I
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`Influence of hazelnut oil phospholipids on the skin moisturizing effect of a cosmetic emulsion. International
`Masson et al. (1990)
`Journal of Cosmetic Science 12,243—251 Influence of hazelnut oil phospholipids on the skin moisturizing effect of a cosmetic
`emulsion
`
`http://www.ewg.org/skindeep/product/40396/GlycoIix_Elite_Treatment_Pads_10%25_%282010_formu|ation%29/#jumptohere
`
`*A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM—YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20130306
`
`0000061
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`0000061
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`
`Reexamination
`
`Application/Control No.
`
`95001774
`
`Certificate Date
`
`App|icant(s)/Patent Under
`Reexamination
`
`&030348
`
`Certificate Number
`
`C1
`
`|:|
`
`Patent Owner
`
`IXI Third Party
`
`Requester Correspondence Address:
`
`CASIMIR JONES, S.C.
`2275 DEMING WAY
`SUITE 310
`
`MIDDLETON, WI 53562
`
`LITIGATION REVIEW XI
`
`Case Name
`
`/BC/
`(examiner initials)
`
`10/21/2011
`(date)
`Director Initials
`
`US DDist Delaware 1 :11cv894 Neptune Technologies v Aker Biom
`
`US Dist Delaware 1 :11cv895 Neptune Technologies v Enzymotec L
`
`COPENDING OFFICE PROCEEDINGS
`
`TYPE OF PROCEEDING
`
`1. none
`
`::
`
`U.S. Qgtgrqtoaan Trademark Office
`
`DOC. CODE RXFILJKT
`
`0000062
`
`

`
`PTO!SBf08a (01-10)
`Doc code: IDS
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`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`95001774
`
`2011-10-19
`
`First Named Inventor
`Fotini Sampalis
`Art Unit
`| 3991
`Examiner Name
`Campell, Bruce R.
`Attorney Docket Number
`| AKBM—32174
`
`E).(‘?m*iner Cite
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`.
`Figures Appear
`
`.'
`.\..!./
`/3 K,.,
`,
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`1
`
`4714571
`
`1987-12-22
`
`Paul A. Tremblay, et al.
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`Application Number
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`95001774
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`2011-10-19
`Filing Date
`Fotini Sampalis
`First Named Inventor
`| 3991
`A“ Unit
`Campe“ Bruce R
`Examiner Name
`Attorney Docket Number
`| AKBM—32174
`
`,
`/
`1513-1’
`
`JOHNSON, L.A., et al., "Comparison of Alternative Solvents for Oil Extraction," JAOCS, Vol. 60, No. 2 (February
`
`1933), pp. 229-242
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`INFORMATION DISCLOSURE
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`STATEMENT BY APPLICANT
`_
`_
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`95001774
`
`Filing Date
`
`2011-10-19
`
`First Named Inventor
`Fotini Sampalis
`Art Unit
`| 3991
`Examiner Name
`Campell, Bruce R.
`Attorney Docket Number
`| AKBM-32174
`
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`SHEET 1 OF 7
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`Complete if Known
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`INFORMATION DISCLOSURE
`STATEMENT LIST
`(Use as many sheets as neeessary)
`
`Control Number
`mm
`Firstilamed Inventor
`
`Examiner Name
`
`Attorney Docket Number U.S. PATENT DOCUMENTS
`
`95/001,774
`
`Bruce R. Campell
`NEPN—003/00US 313663-2015
`
`(AKBM—32174)
`
`.
`Exammer
`Initials*
`
`.
`Cue
`No.1
`
`Document Number
`N mber K'nd Code2 (‘f
`“
`'
`‘
`‘
`known)
`
`
`
`
`.
`.
`Name of Patentee or
`Pages, Columns, Lines, Where
`Pubhcatmn Date
`A l'cant of C'ted
`Rele ant Passa es or Rele ant
`MM-DD-YYYY
`PP ‘
`‘
`V
`.
`g
`V
`Document
`Figures Appear
`
`6“ S 2011/0104297 A1
`
`05-05-2011
`
`Bruheim et al.
`
`6“ S 4,559,234
`
`6“ S 5,230,915
`
`6“ S 5,425,956
`
`12-17-1985
`
`Rubin et al.
`
`07-27-1993
`
`Shahidi et al.
`
`06-20-1995
`
`Shahidi et al.
`
`S 5,443,852
`
`08-22-1995
`
`Shahidi et al.
`
`S 6,083,536