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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/083,668
`
`10/29/2020
`
`Matthew T. Scholz
`
`59889US018
`
`5906
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`PURDY, KYLE A
`
`PAPER NUMBER
`
`ART UNIT
`
`1611
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/02/2023
`
`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)
`
`

`

`Office Action Summary
`
`Application No.
`17/083 ,668
`Examiner
`KYLE A PURDY
`
`Applicant(s)
`Scholz etal.
`Art Unit
`1611
`
`AIA (FITF) Status
`No
`
`-- 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 8/25/2023.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`2a)[¥) This action is FINAL.
`2b) (J 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.
`
`Disposition of Claims*
`102,104-107,109 and 111-124 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`C) Claim(s)__ is/are allowed.
`Claim(s) 102,104-107,109 and 111-124 is/are rejected.
`1) Claim(s)__is/are objectedto.
`Cj} Claim(s)
`are subjectto restriction and/or election requirement
`* 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)
`
`2) (J Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`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 20231030
`
`

`

`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 2
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`DETAILED ACTION
`1. A request for continued examination under 37 CFR 1.114, includingthe feeset forth in 37
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`CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
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`for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been
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`timely paid, the finality of t/e previous Office action has been withdrawnpursuantto 37 CFR
`
`1.114. Applicant's submission filed on 8/25/2023 has been entered.
`
`Status ofApplication
`2. The Examiner acknowledges receipt of the arguments filed 8/25/2023.
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`3. Claims 102, 104-107, 109 and 111-124 are presented for examination on the merits. The
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`following rejections are made.
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`Responseto Applicants’ Arguments
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`4. Applicants argumentsfiled 4/6/2023 regarding the rejection of claims 102, 104-107, 109
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`and 111-121 made by the Examiner under 35 USC 103 (a) over Weietal. (US 2002/0098 159; of
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`record) in view of Scholz (US 5908619) and Wilkins, Jr (US 2004/013 1567; of record) have
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`been fully considered but they are not found persuasive and is MAINTAINEDforthe reasons of
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`record in the office action mailed on 12/6/2022.
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`5. Applicants arguments filed 4/6/2023 regarding the rejection of claim 122 made by the
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`Examiner under 35 USC 103(a) over Weiet al. (US 2002/0098 159; of record) in view of Scholz
`
`(US 5908619) and Wilkins, Jr (US 2004/013 1567; of record), further in view of Watanabeetal.
`
`(1995) have been fully considered but they are not found persuasive and is MAINTAINEDfor
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`the reasons of record in the office action mailed on 12/6/2022.
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`6. In regards to the 103(a) rejection, Applicant asserts the following:
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`

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`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 3
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`A) the Office has not provided any reason why one would assumethat antimicrobial activity
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`intended for a skin surface would be effective when applied to a mucosal surface. Moreover,
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`mucus and mucin biopolymers can bind andinhibit antimicrobials.
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`7. In response to A, as was notedin the previous Office Action regardingthe issue of treating
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`a skin surface and a mucosalsurface, it is not seen whytreatment of one surface would result in
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`loss of antimicrobial activity. Wei teaches that their composition is useful for inhibiting bacterial
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`infections of the skin. Thus, it would be reasonable to expect that whenthe antibacterial
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`composition 1s applied on to other(biological) surfaces, such as a mucosal surface, an outcome
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`of killing unwanted microbes would be achieved. It is noted that Applicant has provided
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`evidence that mucus/mucin can reduce the efficacy of antibiotics. However, the current method
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`is applying a fatty acid and anester of a fatty alcohol which are not seen as structurally
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`analogous to the antibiotics referenced in the response.It is observed howeverthat the
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`mucus/mucin doesnot stop antibiotic activity but rather reduces antibiotic activity meaning that
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`the antibiotic is still capable of killing the target microbe and so even if mucus/mucin did
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`interfere with the inhibition, it would not be sufficient to stop the method from inhibiting the
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`unwanted target microbes.
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`Maintained Rejections, of Record
`Claim Rejections - 35 USC § 103
`
`8. The followingis a quotation of pre-AIA 35 U.S.C. 103(a) which formsthe basis forall
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`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 ofthis 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 obviousat the time the invention was madeto 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.
`
`

`

`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 4
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`9. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness under 35
`
`U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the priorart.
`2. Ascertaining the differences betweenthe priorart and the claimsat issue.
`3. Resolving the level of ordinary skill in the pertinentart.
`4. Considering objective evidence present in the application indicating obviousness or
`nonobviousness.
`
`10. Claims 102, 104-107, 109 and 111-123 are rejected under pre-AIA 35 U.S.C. 103(a)
`
`as being unpatentable over Weiet al. (US 2002/0098159; of record) in view of Scholz (US
`
`5908619) and Wilkins, Jr (US 2004/0131567; of record), evidenced by PubChem: Docusate
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`sodium.
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`11. Wei provides antimicrobial compositions and methods of using such compositions.
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`12. Methods involve applying the antimicrobial composition to the skin to achieve a
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`disinfecting benefit (see [0321]). The amountof the antimicrobial formulation, and the frequency
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`applied, and the period applied vary depending on the disinfection and cleansing desired.
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`Preferably the composition is applied at least once per day, and morepreferably at least three
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`time per day. Inhibition of S$. aureus is contemplated (see [0008]) (see instant claim 102).
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`13. The composition used in the methods may comprise lauric acid (see [0313]) (see instant
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`claim 102, 104, 105, 123 and 124) in an amount ranging from 0.1-10% (see [0302]) (see instant
`
`claim 111). It’s noted that Weiuses lauric acid as a stabilizer. However, as Wei’s lauric acid is
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`chemically identicalto the lauric acid of the claims, it would necessarily possess antimicrobial
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`activity, despite being used for a different purpose (by Wei).
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`14. Wei teaches including an aqueous componentthat includes water, water soluble alcohols
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`such as ethanol, propanolor isopropanol, and mixtures thereof (see [(0091]) in amounts ranging
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`

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`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 5
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`from 10-38 % (see [0093]) (see instant claims 106 and 111). Itis noted that ethanol, propanol and
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`isopropanolare all C1-C10 alkyl alcohols (see instant claim 113).
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`15. Wei also includes an anionic surfactant such as dioctyl esters of sodium sulfosuccinic
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`acid (see [0052]) (see instant claim 112). Itis noted that dioctyl esters of sodium sulfosuccinic
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`acid is docusate sodium (see evidence to PubChem:Docusate).
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`16. Exemplified antimicrobials include quaternary ammonium compounds such as
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`benzalkonium chloride and benzethonium chloride (see [0098] and [0101], respectively) (see
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`instant claims 107-109).
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`17. Wei also exemplifies naturaloils such as limonene(see [0256]) (see instant claim 115).
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`Wei’s also contemplates addition of hydrocarbon oils and waxes such as petrolatum (see [0265]
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`(see instant claim 117).
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`18. Wei’s method utilizes mildness enhancers which provide a moisturizing benefit to the
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`end user. Exemplified mildness enhancersinclude lipophilic skin conditioning agents such
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`as petrolatum and mineraloil (see [0265 ]) (see instant claim 117).
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`19. Wei teaches that their composition may comprise polyols such as glycerine and sorbitol
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`(i.e. polyhydric alcohols) (see [0091]) (see instant claim 116).
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`20. Typical amountsof the composition used in the method range from 0.1 -20 mg/cm (see
`
`[0312]) (see instant claim 118). See MPEP 2144.05(I) regarding overlapping ranges.
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`21.Means for providing the method includes sprays, lotions, powders and wipes (see claim
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`21 and [0318]) (see instant claims 120 and 121)
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`22. Wei’s method fails to include a (C8-C36) alky] or alkenyl ester of a (C8-C18) alkyl or
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`alkenyl alcohol.
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`

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`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 6
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`23. Scholz is directed to hydroalcoholic compositions to be used for topical disinfection. The
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`composition is to comprise an emollient whichis a material that improves the moisture level of
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`the targeted tissue (see column 3, lines 45-48). Exemplified emollients include C8 -C36 alkyl or
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`alkenyl esters of long or straight or branched chain alkyl or alkenyl]alcohols. It is noted that
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`Scholz identifies long chain straight alkyls as being C8 -C36 (see column 15, line 30-50).
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`Therefore, given that Wei contemplates inclusion of an emollient (see [0092]), it would have
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`been obvious to use other well-known emollients suchas those exemplified by Scholz with a
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`reasonable expectation for success in providing a moisturizing benefit.
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`24. Wei’s method fails to apply the antimicrobial composition to the nasal cavity, anterior
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`nares or nasopharynx.
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`25. Wilkins provides antibacterial topical limonene formulations and methods of use
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`wherein the antibacterial formulation is used in methods of killing/inhibiting growth of
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`bacterial externally on the skin or within the nasal cavity by applyingthe antibacterial
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`formulation to the skin or the nasal cavity (see claim 1). One would reasonable expect that
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`modifying Wei suchthat the method applied the composition to nasal cavity would achievethe
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`desired result of killing unwanted microorganisms. The substitution of one knowntechnique
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`(disinfect nasal tissue, Wilkins) for another (disinfect skin, Wei) to obtain predictable resultsis
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`indicia of obviousness. See MPEP 2143. Such an expected outcomeis bolstered given that
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`Wilkins, like Wei, teaches using similar actives (e.g. limonene).
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`26. As to the length of time the composition is applied on to the target tissue and dose
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`applied, these are parameters that one would identify to manipulate so as to provide effective
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`inhibition of unwanted microorganisms. Moreover, it is noted that applying the composition into
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`Application/Control Number: 17/083 ,668
`Art Unit: 1611
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`Page 7
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`the nasal cavity would necessitate applying the compositionto the inside of the nose where the
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`composition, post application, would remain.
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`27. Regarding the antiseptic method as being capable of killing S$. aureus at a rate ofat least
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`6 log reduction after 2.5 minutes, this would be expectedto be the result of the obvious
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`combination of Wei, Scholz and Wilkins given the combination yields the instantly claimed
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`method. Moreover,it is noted that Wei teaches that their composition possesses antibacterial
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`activity against gram positive bacteria such as S. aureus (see [0008]).
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`28. Therefore, the invention as a wholeis prima facie obviousto one of ordinary skill in the
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`art at the time the invention was made, as evidenced by the references, especially in absence of
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`evidenceto the contrary.
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`29. Claim 122 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wei
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`etal. (US 2002/0098159; of record) in view of Scholz (US 5908619) and Wilkins, Jr (US
`
`2004/0131567; of record) as applied to claims 102, 104-106, 107, 109 and 111-123 above,
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`and further in view of Watanabeet al. (Kansenshogaku Azsshi, 1995, 69, abstract).
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`30. Weifails to teach the S. aureus as being methicillin resistant.
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`31. Watanabe teaches that composition of benzalkonium chloride and ethanolare effective at
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`killing methicillin resistant S. aureus. Thus, it would have been obvious to modify Wei’s method
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`to target such a species with a reasonable expectation for success.
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`32. Therefore, the invention as a wholeis prima facie obviousto one of ordinary skill in the
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`art at the time the invention was made, as evidenced by the references, especially in absence of
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`evidenceto the contrary.
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`

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`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 8
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`33. All claimsare either identical to or patentably indistinct from claimsin the application
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`Conclusion
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`prior to the entry of the submission under 37 CFR 1.114 (thatis, restriction would not be proper)
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`and all claims could have beenfinally rejected on the grounds and art of record in the next Office
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`action if they had been entered in the application prior to entry under 37 CFR 1.114.
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`Accordingly, THIS ACTION IS MADEFINALeventhough it is a first action after the filing
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`of a request for continued examination and the submission under 37 CFR 1.114. See MPEP §
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`706.07(b). Applicant is reminded of the extension of timepolicy asset forth in 37 CFR 1.136(a).
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`34.A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHSfrom the mailing date of this action. In the eventa first reply is filed within TWO
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`MONTHSofthe mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR
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`1.136(a) will be calculated from the mailing date of the advisory action. In no event, however,
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`will the statutory period for reply expire later than SIX MONTHSfrom the mailing date of this
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`final action.
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`Anyinquiry concerning this communication or earlier communications from the examiner
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`should be directed to KYLE A PURDYwhose telephone numberis (571)270-3504. The
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`examiner can normally be reached from 9AM to 5PM.
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`35. If attempts to reach the examinerby telephone are unsuccessful, the examiner's
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`supervisor, Bethany Barham, can bereached on 571-272-6175. The fax phone numberfor the
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`organization wherethis application or proceeding is assignedis 571-273-8300.
`
`36. Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`

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`Application/Control Number: 17/083 ,668
`Art Unit: 1611
`
`Page 9
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`maybe 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(toll-free).
`
`/KYLE A PURDY/
`Primary Examiner, Art Unit 1611
`
`