www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/724,019
`
`04/19/2022
`
`Katie F. WLASCHIN
`
`80025US010
`
`1017
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`MAEWALL, SNIGDHA
`
`1612
`
`05/10/2023
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`LegalUSDocketing @ mmm.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1.and 20-23 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`Cj} Claim(s)
`is/are allowed.
`Claim(s)
`1 and 20-23 is/are rejected.
`S)
`) © Claim(s)___is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1... Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have beenreceived in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20230501
`
`Application No.
`Applicant(s)
`47/724,019
`WLASCHIN etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`SNIGDHA MAEWALL
`1612
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s) filed on 04/19/22.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)\0) 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 2
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`Notice of Pre-AlA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA.
`
`Detailed Action
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousnessrejections setforth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall not be
`negated by the manner in which the invention was made.
`
`Claims 1 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Wlaschin et al (USP 8,460,689).
`
`Wlaschin discloses an oral moisturizing composition that also decolonized
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`mammalian oral
`
`tissue (e.g., composition that contacted oral
`
`tissue), see title and
`
`[abstract]. Wlaschin, teaches that a significant segment of the population suffers from
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`xerostomia (dry mouth) and as such,
`
`it
`
`is extremely important that oral
`
`treatment
`
`regiments address both the reduction of microorganisms (plaque removal and reduction
`
`of opportunistic organisms in the oral cavity), and xerostomia, see [col 1, lines 22-23] and
`
`[col 1, lines 60-63]. Wlaschin discloses that the composition comprises edible vegetable
`
`oils in an amount of at least 30 %, see [col 12, lines 14-15] and [col 33, lines 9-13];
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`significant amounts of water (e.g., at least 20 wt. %; e.g., 87.8 % water disclosed in the
`
`example formulations of Table 3), [col 32, lines 1-2]; nonionic surfactants, generally, [col
`
`29, line 63] (0.1 to 10 wt. %disclosedat [col 28, lines 30-38]); 1.6 % xanthan gum (e.g.,
`
`

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`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 3
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`polymeric viscosity modifier) as disclosed in Table 3, Example Formulation # 1]. The
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`composition was formulated as an oil-in-water emulsion with a pH of 3-8 see [col 8, lines
`
`5-7], and [col 11, lines 16-26]. Additionally, Wlaschin generally discloses use of excipients
`
`[col 33,
`
`line 48]. Wlaschin teaches use of thickeners, humectants and excipients in
`
`column 19, lines 52-59. Claim 1 recites 5-70 % plant based oil; 35-95 % aqueous phase;
`
`0.1-7.5 % surfactant; 0.05-3 % viscosity modifier; DH of 4.5-9.5. Wlaschin disclosed edible
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`vegetable oils in an amount of at least 30 %; significant amounts of water (e.g., at least
`
`20 wt. %; e.g., 87.8 % water disclosed in the example formulations of Table 3); nonionic
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`surfactants, generally, (0.1 to 10 wt. %disclosed at [col 28, lines 30-38]); 1.6 % xanthan
`
`gum (e.g., polymeric viscosity modifier) [Table 3, Example Formulation # 1]; pH of 3-8. In
`
`the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior
`
`art", a prima facie case of obviousness exists. MPEP 2144.05 A. Wlaschin discloses use
`
`of fumed silica, see [col 31,
`
`line 56]. Wlaschin discloses use of oils,
`
`including olive,
`
`cottonseed, peanut, corn, sesame, safflower, soybeanoils, and the like, see [col 32, lines
`
`54-57] natural. Further, at Table 2, Wlaschin discloses coconut oil as a comparative
`
`example of an ingredient found in commercially available oral moisturizers. Wlaschin
`
`discloses sweeteners, see [col 17, line 3]. Wlaschin discloses use of aloe vera, see [Table
`
`1]. Wlaschin disclosed enhancer components, including sugar, at not greater than 20 %
`
`[col 25, line 38 to col 26, line, 3]. Wlaschin does not disclose a quaternary antimicrobial
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`compound as a required ingredient. Wlaschin discloses a viscosity of at least 10,000 or
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`in excess of 50,000 cps, see [col 11, lines 41-49]. Wlaschin discloses a physically stable
`
`compositions at 25 ° C, see [col 17, lines 23-27]. Wlaschin taught excipients at increasing
`
`amounts (e.g., Wlaschin disclosed excipients at 0.5-2 % at Tables 12-16). Since the art
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`

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`Application/Control Number: 17/724,019
`Art Unit: 1612
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`Page 4
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`teaches treating xerostomia, it would implicitly increase lubriciousnessin an oral tissue.
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`Since the art teaches pH of 3-8.
`
`In the case where the claimed ranges “overlap or lie
`
`inside ranges disclosedbythe prior art", a prima facie case of obviousness exists. MPEP
`
`2144.05 A. Thus, it would have been obvious to one of ordinary skill to have formulated
`
`an oral composition for treating xerostomia comprising plant based oils, aqueous phase,
`
`surfactant and viscosity modifier with a pH of 3-8 which overlaps with the claimed range
`
`of 4.5 to 9.5 and thus creates case of obviousness and combining prior art elements
`
`according to their known function would have provided predictable results of oral
`
`composition for treating xerostomia, see MPEP 2143 part(I)(A).
`
`Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over
`
`Wlaschin et al (USP 8,460,689), in view of Hunter et al (USP 6,159,459).
`
`Wlaschin generally discloses [col 33, line 49] lubricants.
`
`Wlaschin does not specifically disclose that the composition increasedlubricity or
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`lubriciousness, as recited in claim 22.
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`Hunter discloses [abstract] an oral
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`lubricant
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`(beta-glucan polymer) having
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`particular usefulnessfor alleviating the symptoms of xerostomia. As per Hunter [col 1,
`
`lines 16-22], xerostomia, in which the salivary glands do not produce sufficient quantities
`
`of saliva, causes discomfort which can in some cases be quite severe. Without saliva,
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`the mouth burns and the throat and tongue can undergo radical changes. Teeth can
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`decay rapidly and the tongue can become smooth, cracked and vulnerable to infection.
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`As such, [col 2, lines 13-23], it is most desirable to have an oral lubricating composition
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`for humanuse, to relieve the discomforts and inconveniencesincurred by xerostomia and
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`dryness of the mouth. Hunter's composition [col 2, lines 13-23 and at lines 31-37] had
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`

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`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 5
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`rheological properties that were as close to the properties of natural salivary secretion as
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`possible. Said composition exhibited improvedlubricity, thereby providing long-term relief
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`from the symptoms of xerostomia or dry mouth. Since Wlaschin generally disclosed
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`lubricants, it would have been prima facie obvious to one of ordinary skill in the art to
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`include Hunter’s lubricant within Wlaschin. An ordinarily skilled artisan would have been
`
`motivated because Wlaschin disclosed that a significant segment of the population suffer
`
`from xerostomia, and thatit is extremely important to address the reduction of xerostomia
`
`(previously discussed). Further, Hunter’s composition had rheological properties that
`
`were as close to the properties of natural salivary secretion as possible. Said
`
`compositions exhibited improved lubricity, thereby providing long-term relief from the
`
`symptoms of xerostomia or dry mouth.
`
`Nonstatutory Double Patenting
`
`A nonstatutory 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., /n 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); 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)
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`may be used to overcome an actual or provisional rejection based on nonstatutory double
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`

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`Application/Control Number: 17/724,019
`Art Unit: 1612
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`Page 6
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`patenting provided the reference application or patent either is shown to be commonly
`
`owned with the examined application, or claims an invention made as a result of activities
`
`undertaken within the scope of a joint research agreement. See MPEP § 717.02 for
`
`applications subject to examination under the first inventor to file provisions of the AIA as
`
`explained in MPEP § 2159. See MPEP §§ 706.02(I)(1) - 706.02(I)(3) for applications not
`
`subject to examination under the first inventor to file provisions of the AIA. A terminal
`
`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTOInternet website contains terminal disclaimer forms which may be used.
`
`Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in
`
`which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26,
`
`PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may
`
`be filled out completely online using web-screens. An eTerminal Disclaimer that meets
`
`all requirements is auto-processed and approved immediately upon submission. For
`
`moreinformation about eTerminal Disclaimers, refer to
`
`www.uspto.gov/patents/process/file/efs/guidance/eT D-info-l.jsp.
`
`Claims 1 and 20-23 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 2-3, 6-8, 10-17, 19-20 and 24, 26 and 28 of
`
`copending Application No. 16/196872.
`
`Although the claims at issue are not identical, they are not patentably distinct from
`
`each other. The instant claims recite a composition comprising: from 5 wt-% to 70 wt-%
`
`of one or more plant based oils based on the total weight of the composition; from 35 wt-
`
`% to 95 wt-% of an aqueous phase basedon the total weight of the composition; from 0.1
`
`wt-% to 7.5 wt-%total of one or more surfactants, based on the total weight of the
`
`

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`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 7
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`composition, wherein the one or more surfactants are selected from the group consisting
`
`of ethylene oxide/propylene oxide (EO/PO) free, nonionic surfactants, surfactant of
`
`formula |; from 0.05 wt %to 3 wt-%total of one or more viscosity modifiers, based on the
`
`total weight of the composition, wherein the viscosity modifier comprises ethyl cellulose;
`
`wherein the composition has a pH from 4.5 to 9.5, the composition is an oil in water (o/w)
`
`emulsion, and the composition is edible.
`
`The copending claims recite a method of affecting the effects of xerostomia, dry
`
`mouth, or both, the method comprising: contacting an oral tissue with a composition
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`comprising; from 5 wt-% to 30 wt-% of one or more plant based oils based on the total
`
`weight of the composition; from 70 wt-% to 95 wt-% of an aqueous phase based on the
`
`total weight of the composition; from 0.1 wt-% to 5 wt-%total of one or more surfactants,
`
`based on the total weight of the composition, wherein the one or more surfactants are
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`selected from the group consisting of (i) ethylene oxide/propylene oxide (EO/PO)free,
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`nonionic surfactants, (ii) a surfactant of formula I: HOCH2-(CHOH)n-CH2NR1R2(I)
`
`wherein R1 and R2 are independently selected from the group consisting of a
`
`hydrogen atom, an alkyl group, C(0)R3, and S02R4; with R3 and R4 being independently
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`selected from the group consisting of an alkyl group, an aryl group, and an aralkyl group;
`
`wherein n is an integer from about 2 to about 5; and (ili) combinations of surfactants from
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`surfactant group (i) and surfactant group (ii); from 0.1% wt % to 2 wt-%total of one or
`
`more viscosity modifiers, based on the total weight of the composition, wherein the
`
`viscosity modifier comprises ethyl cellulose; wherein the composition has a pH from 4.5
`
`to 9.5, the composition is an oil in water (o/w) emulsion, and the composition is edible.
`
`The copending method of affecting the effects of xerostomia with the composition reads
`
`

`

`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 8
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`on the instant method and the composition comprising plant based oils, surfactants,
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`aqueous phase and viscosity modifiers. This is a provisional nonstatutory double
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`patenting rejection because the patentably indistinct claims have not
`
`in fact been
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`patented.
`
`Claims 1 and 20-23 are rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claims 1-20 of USP (11,324,681).
`
`Although the claims at issue are not identical, they are not patentably distinct from
`
`each other. The instant claims recite a composition comprising: from 5 wt-% to 70 wt-%
`
`of one or more plant based oils based on the total weight of the composition; from 35 wt-
`
`% to 95 wt-% of an aqueous phase basedon the total weight of the composition; from 0.1
`
`wt-% to 7.5 wt-%total of one or more surfactants, based on the total weight of the
`
`composition, wherein the one or more surfactants are selected from the group consisting
`
`of ethylene oxide/propylene oxide (EO/PO) free, nonionic surfactants, surfactant of
`
`formula |; from 0.05 wt %to 3 wt-%total of one or more viscosity modifiers, based on the
`
`total weight of the composition, wherein the viscosity modifier comprises ethyl cellulose;
`
`wherein the composition has a pH from 4.5 to 9.5, the composition is an oil in water (o/w)
`
`emulsion, and the composition is edible.
`
`The patented claims recite a composition comprising: an oil phase comprising: one
`
`or more plant-based oils present in an amount from 5 wt-%to 70 wt-% based on the total
`
`weight of the composition; an aqueous phase comprising: water, wherein the aqueous
`
`phase is present in an amount from 35 wt-% to 95 wt-% based on the total weight of the
`
`composition; one or more surfactant present in a total amount from 0.1 wt-%to 7.5 wt-%
`
`based on the total weight of the composition, the one or more surfactant selected from
`
`

`

`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 9
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`the group consisting of: a nonionic surfactant excluding ethylene oxide/propylene oxide
`
`(EO/PO),
`
`and
`
`a_
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`surfactant
`
`of
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`formula’
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`1: HOCH.sub.2—(CHOH).sub.n—
`
`CH.sub.2NR.sup.1R.sup.2
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`(I) wherein: R.sup.1 and R.sup.2 are independently
`
`selected from the group consisting of a hydrogen atom, an alkyl group, C(O)R.sup.3, and
`
`SO.sub.2R.sup.4; R.sup.3 and R.sup.4 are independently selected from the group
`
`consisting of an alkyl group, an aryl group, and an aralkyl group; wherein n is an integer
`
`from about 2 to about 5, wherein at least one surfactant is a polyglycerol ester; viscosity
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`modifiers present in a total amount from 0.05 wt % to 3 wt-% basedon the total weight of
`
`the composition, wherein at least one viscosity modifier is ethyl cellulose, and at least one
`
`viscosity modifier is selected from hydroxypropyl guar and xanthan gum, wherein ethyl
`
`cellulose is present in an amount of at least 2 wt % based on the weight of the oil phase,
`
`wherein the composition has a pH from 4.5 to 9.5, wherein the composition is an oil-in-
`
`water (o/w) emulsion, and wherein the composition is edible. The patented method of
`
`affecting the effects of xerostomia with the composition reads on the instant method and
`
`the composition comprising plant basedoils, surfactants, aqueous phase and viscosity
`
`modifiers.
`
`Correspondence
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to SNIGDHA MAEWALL whosetelephone number is
`
`(571)272-6197. The examiner can normally be reached on Mondaythru Friday; 8:30
`
`AM to 5PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Frederick Krass can be reached on 571-272-0580. The fax phone number
`
`

`

`Application/Control Number: 17/724,019
`Art Unit: 1612
`
`Page 10
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`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published
`
`applications may be obtained from either Private PAIR or Public PAIR. Status
`
`information for unpublished applications is available through Private PAIR only. For
`
`more information about the PAIR system, see http://pair-direct.uspto.gov. Should you
`
`have questions on accessto the Private PAIR system, contact the Electronic Business
`
`Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a USPTO
`
`Customer Service Representative or access to the automatedinformation system, call
`
`800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/SNIGDHA MAEWALL/
`Primary Examiner, Art Unit 1612
`
`