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.
`
`13/189,714
`
`07/25/2011
`
`Fotini Sampalis
`
`NEPN—001/02US
`3 13663-2013
`
`1767
`
`COOLEY LLP759O
`ATTN: Patent Group
`Suite 1 100
`777 — 6th Street, NW
`WASHINGTON, DC 20001
`
`POLANSKY, GREGG
`
`1629
`
`MAIL DATE
`
`01/05/2012
`
`PAPER NUMBER
`
`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.
`
`PTOL—90A (Rev. 04/07)
`
`000001
`
`Petition for Inter Partes Review
`Of U.S. Patent 8,278,351
`Exhibit
`
`
`
`ENZYMOTEC - 1063
`
`000001
`
`

`
`Office Action Summary
`
`Application No.
`
`App|icant(s)
`
`13/189,714
`
`Examiner
`
`SAMPALIS, FOTINI
`
`Art Unit
`
`1629
`Gregg Polansky
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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.
`If 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).
`
`Status
`
`1)IXl Responsive to communication(s) filed on 24 October 2011.
`
`2a)I:I This action is FINAL.
`
`2b)IXI This action is non—final.
`
`3)I:l 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.
`
`4)I:l Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Ouayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)Xl Claim(s)1-:20is/are pending in the application.
`
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`
`6)I:l Claim(s) j is/are allowed.
`
`7)|Xl Claim(s)1-:20is/are rejected.
`
`8)I:l Claim(s) _ is/are objected to.
`
`9)I:l Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`10)|:l The specification is objected to by the Examiner.
`
`11)I:l The drawing(s) filed on j is/are: a)I:I accepted or b)I:I 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).
`
`12)I:l The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`13)I:l Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)I:I All
`
`b)I:I Some * c)I:l None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No. j.
`
`3.I:I 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)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) Q Notice of References Cited (PTO-892)
`2) El Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) El Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`
`4) El Interview Summary (PTO-413)
`Paper N°(3)/IVI-3“ DaT9- L
`5) I:I NOTICQ Of Inform-3' Patent APPIICaTI0“
`6) D Other:
`.
`
`PTOL-326 (Rev. 03-11)
`
`Office Action Summary
`000002
`
`Part of Paper No./Mail Date 20111220
`
`000002
`
`

`
`Application/Control Number: 13/189,714
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`Page 2
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`Art Unit: 1629
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`DETAILED ACTION
`
`Status of Claims
`
`1.
`
`Claims 1-20 are pending and presently under consideration.
`
`Claim Rejections - 35 USC § 1 12
`
`2.
`
`The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
`
`Subject to the [fifth paragraph of 35 U.S.C. 112], 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 reference all the limitations of the claim to which it
`refers.
`
`3.
`
`Claims 12-15 are rejected under 35 U.S.C. 112, 4th paragraph, as being of
`
`improper dependent form 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.
`
`Claim 12 is drawn to the composition of Claim 1, wherein the phospholipid
`
`comprises phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol,
`
`phosphatidylserine, sphingomyelin or a mixture thereof. This is not further limiting of
`
`Claim 1 because Claim 1
`
`limits the claimed phospholipid to phosphatidylethanolamine
`
`(when X is —CH2CH2NH3) or phosphatidylcholine (when X is ——CH2CH2N(CH3)2).
`
`Claim 13 is drawn to the composition of Claim 1, wherein the phospholipid
`
`comprises saturated, monounsaturated or polyunsaturated fatty acids. This is not
`
`further limiting of Claim 1 because the phospholipid recited in Claim 1, as depicted by
`
`000003
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`000003
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`

`
`Application/Control Number: 13/189,714
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`Page 3
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`Art Unit: 1629
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`formula (I), comprises two polyunsaturated fatty acids (DHA and EPA) and the formula
`
`does not allow for any modification with regard to the attached fatty acids.
`
`Claim 14 is drawn to the composition of Claim 13, wherein the polyunsaturated
`
`fatty acids are selected from the group consisting of omega-3 and omega-6 fatty acids.
`
`This is not further limiting of Claim 13 and Claim 1 because the phospholipid recited in
`
`Claim 1 (from which Claim 13 depends), as depicted by formula (I), comprises two
`
`omega-3 polyunsaturated fatty acids (DHA and EPA) and the formula does not allow for
`
`any modification with regard to the attached fatty acids.
`
`Claim 15 is drawn to the composition of Claim 13, wherein the polyunsaturated
`
`fatty acids are selected from the group consisting of DHA, EPA, myritstic acid,
`
`myristoleic acid, lignoceric acid, linolenic acid, alpha linolenic acid, nurvonic acid,
`
`linoleic acid, oleic acid, stearic acid, palmitic acid and palmitoleic acid. This is not
`
`further limiting of Claim 13 and Claim 1 because the phospholipid recited in Claim 1
`
`(from which Claims 13 and 15 depend), as depicted by formula (I), comprises DHA and
`
`EPA and the formula does not allow for any modification with regard to the attached
`
`fatty acids. Further, of the 13 fatty acids recited in Claim 15, only 5 are polyunsaturated
`
`(i.e., EPA, DHA, linolenic acid, alpha linolenic acid and linoleic acid). The remaining 8
`
`fatty acids recited by the claim are either monounsaturated or saturated.
`
`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.
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`000004
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`000004
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`

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`Application/Control Number: 13/189,714
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`Page 4
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`Art Unit: 1629
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`4.
`
`The following is a quotation of the second paragraph of 35 U.S.C. 112:
`
`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.
`
`5.
`
`Claims 1-20 are rejected under 35 U.S.C. 112, second paragraph, as being
`
`indefinite for failing to particularly point out and distinctly claim the subject matter which
`
`applicant regards as the invention.
`
`Claim 1, as presently recited, is (emphasis added):
`
`'
`
`- é‘H:L’§t1t;1;$s)S~i'E't.m1, mmprisingz
`
`M ;:s§.l1sm‘s:~‘;;:ihoEi;:~‘ii:il. E.\f'$:f?i£$ g.t:.‘;'l$‘;£¥",£1§ -l":;'e:‘-i‘2,o1;'1.xii.zac {ii};
`
`The claim can have multiple interpretations which are incompatible with each
`
`other. For instance, the claim can reasonably be interpreted as reading on a
`
`000005
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`000005
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`

`
`Application/Control Number: 13/189,714
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`Page 5
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`Art Unit: 1629
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`composition comprising the phospholipid of formula (I), wherein X is —CH2CH2NH3,
`
`—-CH2CH2N(CH3)2 or the flavonoid of formula (II). The claim can also reasonably be
`
`interpreted as reading on a composition comprising the phospholipid of formula (I) Q
`
`the flavonoid of formula (II). A further claim interpretation is that it is drawn to a
`
`composition comprising a phospholipid of formula (I) and a flavonoid of formula (II),
`
`wherein X of formuIa(I) is —CH2CH2NH3 or ——CH2CH2N(CH3)2.
`
`A claim allowing for multiple interpretations is indefinite and, as such, is deemed
`
`inconsistent with the tenor and express language of 35 U.S.C. § 112, second
`
`paragraph.
`
`Similarly, Claims 9-11 can have multiple interpretations. Claim 9 recites “The
`
`composition according to claim 1, comprising at least about 40% w/w phosphoIipid.” It
`
`is not clear from the claim whether the phospholipid recited in Claim 9 is the
`
`phospholipid of formula (I) as recited in Claim 1, or whether the phospholipid of Claim 9
`
`is referring to all phospholipids present in the composition of Claim 1 (i.e., the
`
`phospholipid of formula (I) and other phospholipids present in the composition). The
`
`same uncertainty exists for Claims 10 and 11. Claim 10 is drawn to the composition of
`
`Claim 9, comprising at least about 45% w/w phospholipid (i.e., is it at least 45% w/w
`
`phospholipid of formula (I) or 45% total phospholipids, comprising formula (I) and other
`
`phospholipids) and Claim 11 is drawn to the composition of Claim 10, comprising from
`
`about 45 to 60% w/w phospholipid (i.e., is it about 45 to 60% w/w phospholipid of
`
`formula (I) or 45 to 60% total phospholipids, comprising formula (I) and other
`
`phospholipids).
`
`000006
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`000006
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`

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`Application/Control Number: 13/189,714
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`Page 6
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`Art Unit: 1629
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`Claim 15 is indefinite because, while it is drawn to polyunsaturated fatty acids
`
`selected from the group consisting of DHA, EPA, myritstic acid, myristoleic acid,
`
`lignoceric acid, linolenic acid, alpha linolenic acid, nurvonic acid, linoleic acid, oleic acid,
`
`stearic acid, palmitic acid and palmitoleic acid, not all the listed fatty acids are
`
`polyunsaturated (i.e., EPA, DHA, linolenic acid, alpha linolenic acid and linoleic acid).
`
`The remaining 8 fatty acids recited by the claim are either monounsaturated or
`
`saturated. Therefore, the skilled artisan would be unable to determine the metes and
`
`bounds of the claim, since some fatty acids of the claim body are not polyunsaturated
`
`as recited in the preamble.
`
`Claim 16 is drawn to the composition according to Claim 1, wherein the
`
`phospholipid further comprises an additional lipid component. Although it is clear that
`
`the composition of Claim 1 can further comprise an additional lipid component, it is not
`
`clear how the phospholipid of Claim 1 can comprise an additional lipid component.
`
`Claim 20 recites the limitation "The composition according to claim 1 wherein
`
`polyunsaturated fatty acids comprise at least about 15% w/w of the total lipids in the
`
`composition." There is insufficient antecedent basis for this limitation in the claim. The
`
`composition of Claim 1 does not recite polyunsaturated fatty acids.
`
`Claim Rejections - 35 USC § 102
`
`6.
`
`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 —
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`000007
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`000007
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`

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`Application/Control Number: 13/189,714
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`Page 7
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`Art Unit: 1629
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`(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.
`
`7.
`
`Claims 1-20 are rejected under 35 U.S.C. 102(b) as being anticipated by
`
`Beaudoin et al. (WO O0/23546).
`
`Beaudoin et al. teach extraction methods to produce, inter alia, a krill extract.
`
`See Abstract.
`
`Instant Applicant discloses that the instant krill extract was prepared
`
`using the same extraction methods disclosed in WO O0/23546 (Beaudoin et al.).
`
`Indeed, the summary of the extraction disclosed in the instant Specification mirrors the
`
`extraction process taught by Beaudoin et al. See instant Specification, pages 31-32,
`
`Beaudoin et al., pages 4-6, and pages 29-32, claims 1-24). The marine starting
`
`material (krill) and the extraction procedures are the same for the instant invention and
`
`in the disclosure of Beaudoin et al. The starting material (e.g., krill) is “freshly harvested
`
`and preferably finely divided”. See page 5, lines 22-23. The use of frozen krill is recited
`
`throughout the disclosure by Beaudoin et al. The initial extraction (processing) of the
`
`krill is conducted at a temperature of about 5 degrees C or less. See, page 5, lines 27-
`
`28, and Table 19, page 28. Thus, the composition of the extract (including, for example,
`
`the instantly claimed flavonoid of formula (II)), and the characteristics of the extract are
`
`reasonably expected to be the same as what is instantly claimed. For example, see
`
`Tables 12-18.
`
`It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594)
`
`discuss the support of rejections wherein the prior art discloses subject matter, which
`
`there is reason to believe inherently includes functions that are newly cited, or is
`
`identical to a product instantly claimed.
`
`In such a situation the burden is shifted to the
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`000008
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`000008
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`Application/Control Number: 13/189,714
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`Page 8
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`Art Unit: 1629
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`applicant to “prove that subject matter to be shown in the prior art does not possess the
`
`characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is
`
`no requirement that a person of ordinary skill in the art would have recognized the
`
`inherent disclosure at the time of invention, but only that the subject matter is in fact
`
`inherent in the prior art reference. Schering Corp. v. Geneva Pharm. lnc., 339 F.3d
`
`1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere &
`
`Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a
`
`characteristic is a necessary feature or result of a prior-art embodiment (that is itself
`
`sufficiently described and enabled) is enough for inherent anticipation, even if that fact
`
`was unknown at the time of the prior invention”). Also see SmithKline Beecham Corp.
`
`v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005)
`
`(holding that a prior art patent to an anhydrous form of a compound "inherently"
`
`anticipated the claimed hemihydrate form of the compound because practicing the
`
`process in the prior art to manufacture the anhydrous compound "inherently results in at
`
`least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or
`
`recognize the hemihydrate).
`
`Absent evidence to the contrary, the extracts taught by Beaudoin et al. have the
`
`same characteristics of the instantly claimed composition. Therefore, Beaudoin et al.
`
`fully anticipates instant Claims 1-20.
`
`A reference is good not only for what it teaches by direct anticipation but also for
`
`what one of ordinary skill in the art might reasonably infer from the teachings. (In re
`
`000009
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`000009
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`Application/Control Number: 13/189,714
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`Page 9
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`Art Unit: 1629
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`Opprecht12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA)
`
`1976).
`
`Double Parenting
`
`8.
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory
`
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`
`are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference claim(s) because the examined application claim is either anticipated
`
`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
`
`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
`
`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`
`1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422
`
`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`
`USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the conflicting application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
`
`activities undertaken within the scope of a joint research agreement.
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`Application/Control Number: 13/189,714
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`Page 10
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`Art Unit: 1629
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`Effective January 1, 1994, a registered attorney or agent of record may sign a
`
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`
`37 CFR 3.73(b).
`
`9.
`
`Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claims 1-21 of U.S. Patent No. 8,030,348.
`
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`each other. As discussed above, instant Claim 1 can reasonably be interpreted as
`
`reading on a composition comprising the phospholipid of formula (I), wherein X is —
`
`CH2CH2NH3, --CH2CH2N(CH3)2 or the flavonoid of formula (II). The claim can also
`
`reasonably be interpreted as reading on a composition comprising the phospholipid of
`
`formula (I) _rthe flavonoid of formula (II). When Claim 1
`
`is considered following either
`
`of the above interpretations, the claims from conflicting patent ‘348 read on the instant
`
`claims. Whereas instant Claim 1
`
`is drawn to a composition comprising the phospholipid
`
`of formula (I) (the structure having a DHA and EPA moiety attached to the glycerol
`
`chain), it is anticipated by claim 1 of the ‘348 patent where either R1 or R2 is EPA and
`
`the other is DHA (e.g., claim 19 of the ‘348 patent). The open language of the instant
`
`claims allow for the inclusion of additional components recited by the conflicting claims.
`
`10.
`
`Claim 1
`
`is provisionally rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claims 13-15 of copending Application No.
`
`12/915724. Although the conflicting claims are not identical, they are not patentably
`
`distinct from each other because when instant Claim 1
`
`is interpreted as reading on a
`
`composition comprising the phospholipid of formula (I), wherein X is —CH2CH2NH3,
`
`0000011
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`0000011
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`

`
`Application/Control Number: 13/189,714
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`Page 11
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`Art Unit: 1629
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`--CH2CH2N(CH3)2 or the flavonoid of formula (II); or when Claim 1
`
`is interpreted as
`
`reading on a composition comprising the phospholipid of formula (I) o_r the flavonoid of
`
`formula (II) (see discussion above concerning the interpretation of Claim 1), it is
`
`anticipated by conflicting claims 13-15.
`
`This is a provisional obviousness-type double patenting rejection because the
`
`conflicting claims have not in fact been patented.
`
`Conclusion
`
`11.
`
`Claims 1-20 are rejected.
`
`12.
`
`No claims are allowed.
`
`13.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Gregg Polansky whose telephone number is (571)272-
`
`9070. The examiner can normally be reached on Mon-Thur 9:30 A.M. - 7:00 P.M. EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jeffrey S. Lundgren can be reached on (571) 272-5541. The fax phone
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`number for the organization where this application or proceeding is assigned is 571 -
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`273-8300.
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`Application/Control Number: 13/189,714
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`Page 12
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`Art Unit: 1629
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`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 (toII—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.
`
`/Gregg PoIansky/
`Examiner, Art Unit 1629
`
`/James D Anderson/
`
`Primary Examiner, Art Unit 1629
`
`0000013
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`0000013
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`

`
`Notice of References Cited Examiner
`
`Application/Control No.
`
`13/189714
`
`Gregg Polansky
`U.S. PATENT DOCUMENTS
`
`App|icant(s)/Patent Under
`Reexamination
`SAMPALIS FOTINI
`Art Unit
`
`1629
`
`Page 1 of 1
`
`*
`
`Document Number
`Country Code—Number—Kind Code
`
`Date
`MM-YYYY
`
`Name
`
`_
`_
`_
`C|aSS'f'Cat'°n
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`Il
`
`j
`lujjjmj
`lnjjjmj
`lnjjjmj
`lnjjjmj
`l
`l
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`*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. 20111220
`
`0000014
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`0000014