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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
`
`05/25/2023
`
`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 4/6/2023.
`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 20230519
`
`

`

`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 2
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`DETAILED ACTION
`
`Status ofApplication
`1. The Examiner acknowledges receipt of the amendments filed on 4/6/2023 wherein
`
`claims 102, 107, 112 and 122 have been amended, claims 103 and 108 have been
`
`cancelled and claims 123 and 124 have been added.
`
`2. Claims 102, 104-106, 107, 109 and 111-124 are presented for examination on the
`
`merits. The following rejections are made.
`
`Response to Applicants’ Arguments
`
`3. Applicants arguments filed 4/6/2023 regarding the rejection of claims 102, 104-
`
`106, 107, 109 and 111-121 made by the Examiner under 35 USC 103(a) over Weiet al.
`
`(US 2002/0098159; of record) in view of Scholz (US 5908619) and Wilkins, Jr (US
`
`2004/0131567; of record) have been fully considered but they are not found persuasive
`
`and is MAINTAINEDforthe reasons of record in the office action mailed on 12/6/2022.
`
`4. Applicants arguments filed 4/6/2023 regarding the rejection of claim 122 made by
`
`the Examiner under 35 USC 103(a) over Wei et al. (US 2002/0098159; of record) in view
`
`of Scholz (US 5908619) and Wilkins, Jr (US 2004/0131567; of record), further in view
`
`of Watanabe et al. (1995) have been fully considered but they are not found persuasive
`
`and is MAINTAINEDforthe reasons of record in the office action mailed on 12/6/2022.
`
`5. In regards to the 103(a) rejection, Applicant asserts the following:
`
`A)
`
`Weiteaches that S. aureus is Gram positive whereasE. coli is Gram negative. Both are
`
`not described by Wei as Gram positive. Moreover, the Office has not provided any
`
`reason one would assumethat antimicrobial activity on askin surface would be effective
`
`on a mucosal surface; and
`
`

`

`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 3
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`B) Scholz does not teach emollients for use on mucosal membranes, nor does Scholz
`
`mention that emollients can be used in formulations against Gram positive bacteria.
`
`6. In response to A, the Examiner agrees. The Examiner mischaracterized Wei’s teaching.
`
`This, however, does not mitigate the obviousness rejection as the framework for nhibiting
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`bacteria, gram positive and gram negative, would have been readily envisaged from Wei's
`
`teaching.
`
`7. Regarding the issue of treating a skin surface and a mucosalsurface, it is not seen why
`
`treatment of one surface would result in loss of antimicrobial activity. Wei teaches that their
`
`composition is useful for inhibiting bacterial infections of the skin. Thus, it would be reasonable
`
`to expect the antibacterial composition to be used on other biological surfaces, such as a mucosal
`
`surface, and expect a similar outcome. Applicant has provided no evidence or articulated a
`
`reason as to why would not expect a similar outcome.
`
`8. In response to B, emollients are described by Wei. See [0092]. Thus, it would have been
`
`obvious to look to the prior art for other known emollients commonly used in similar type
`
`compositions, Le. those described by Scholz. The selection of a known material based onits
`
`suitability for an mtended purpose is indicia of obviousness.
`
`Claim Rejections - 35 USC § 103
`
`9. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in sect ion
`102 of thistitle, if the differences between the subject matter sought to be patented and the prior art are such that the
`subject matter as a whole would have been obvious at the time the invention was made toa 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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`10. The factual inquiries set forth n Grahamv. 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 asfollows:
`
`wnr
`
`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims atissue.
`Resolving the level of ordinary skill
`in the pertinent art.
`Considering objective evidence present in the application indicating obviousness or
`nonobviousness.
`
`4.
`
`11. Claims 102, 104-106, 107, 109 and 111-123 are rejected under pre-AIA 35
`
`U.S.C. 103(a) as being unpatentable over Wei et al. (US 2002/0098159; ofrecord) in
`
`vie w of Scholz (US 5908619) and Wilkins, Jr (US 2004/0131567; ofrecord),
`
`evidenced by PubChem: Docusate sodium.
`
`12. Wei provides antimicrobial compositions and methods of using such
`
`compositions.
`
`13. Methods involve applying the antimicrobial composition to the skin to achieve a
`
`disinfecting benefit (see [0321]). The amount of the antimicrobial formulation, and the
`
`frequency applied, and the period applied vary depending on the disinfection and
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`cleansing desired. Preferably the composition is applied at least once per day, and more
`
`preferably at least three time per day.
`
`Inhibition of S. aureus is contemplated (see
`
`[0008]) (see instant claim 102).
`
`14. The composition used in the methods may comprise lauric acid (see [0313])
`
`(see instant 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 Wei uses lauric acid as a stabilizer.
`
`However, as Wei’s lauric acid is chemically identical to the lauric acid of the claims,
`
`it
`
`

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`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 5
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`would necessarily possess antimicrobial activity, despite being used for a different
`
`purpose (by Wei).
`
`15. Wei teaches including an aqueous component that includes water, water
`
`soluble alcohols such as ethanol, propanol or isopropanol, and mixtures thereof
`
`(see [0091]) in amounts ranging from 10-38 % (see [0093]) (see instant claims 106 and
`
`111). It is noted that ethanol, propanol and isopropanol are all C1-C10 alkyl alcohols (see
`
`instant claim 113).
`
`16. Wei also includes an anionic surfactant such as dioctyl esters of sodium
`
`sulfosuccinic acid (see [0052]) (see instant claim 112). It is noted that dioctyl esters of
`
`sodium sulfosuccinic acid is docusate sodium (see evidence to PubChem:Docusate).
`
`17. Exemplified antimicrobials include quaternary ammonium compounds such as
`
`benzalkonium chloride and benzethonium chloride (see [0098] and [0101],
`
`respectively) (see instant claims 107-109).
`
`18. Wei also exemplifies natural oils suchas limonene (see [0256]) (see instant
`
`claim 115). Wei’s also contemplates addition of hydrocarbon oils and waxes such as
`
`petrolatum (see [0265] (see instant claim 117).
`
`19. Wei’s method utilizes mildness enhancers which provide a moisturizing benefit to
`
`the end user. Exemplified mildness enhancers include lipophilic skin conditioning agents
`
`such as petrolatum and mineral oil (see [0265]) (see instant claim 117).
`
`20. Wei teaches that their composition may comprise polyols such as glycerine and
`
`sorbitol (i.e. polyhydric alcohols) (see [0091]) (see instant claim 116).
`
`21. Typical amounts of 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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`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 6
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`22. Means for providing the method includes sprays, lotions, powders and wipes (see
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`claim 21 and [0318]) (see instant claims 120 and 121)
`
`23. Wei’s methodfails to include a (C8-C36) alkyl or alkenyl ester of a (C8-C18)
`
`alkyl or alkenyl alcohol.
`
`24. Scholz is directed to hydroalcoholic compositions to be used for topical
`
`disinfection. The composition is to comprise an emollient which is a material that
`
`improves the moisture level of the targeted tissue (see column 3, lines 45-48).
`
`Exemplified emollients include C8-C36 alkyl or alkenyl esters of long or straight or
`
`branched chain alkyl or alkenyl alcohols. It is noted that Scholz identifies long chain
`
`straight alkyls as being C8-C36 (see column 15, line 30-50). Therefore, given that Wei
`
`contemplates inclusion of an emollient (see [0092]),
`
`it would have been obvious to use
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`other well-known emollients such as those exemplified by Scholz with a reasonable
`
`expectation for success in providing a moisturizing benefit.
`
`25. Wei’s methodfails to apply the antimicrobial composition to the nasal cavity,
`
`anterior nares or nasopharynx.
`
`26. Wilkins provides antibacterial topical limonene formulations and methods of use
`
`wherein the antibacterial formulation is used in methods ofkillng/inhibiting growth of
`
`bacterial externally on the skin or within the nasal cavity by applying the antibacterial
`
`formulation to the skin or the nasal cavity (see claim 1).. One would reasonable expect
`
`that modifying Wei such that the method applied the composition to nasal cavity would
`
`achieve the desired result of kiling unwanted microorganisms. The substitution of one
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`knowntechnique (disinfect nasal tissue, Wilkins)
`
`for another (disinfect skin, Wei) to
`
`obtain predictable results is indicia of obviousness. See MPEP 2143. Such an expected
`
`

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`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 7
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`outcome is bolstered given that Wilkins,
`
`like Wei, teaches using similar actives (e.g.
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`lmmonene).
`
`27. As to the length of time the composition is applied on to the target tissue and dose
`
`applied, these are parameters that one would identify to manipulate so as to provide
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`effective inhibition of unwanted microorganisms. Moreover, it is noted that applying the
`
`composition into the nasal cavity would necessitate applyng the composition to the
`
`inside of the nose where the composition, post application, would remain.
`
`28. Regarding the antiseptic method as being capable ofkilling S. aureus ata rate of
`
`at least 6 log reduction after 2.5 minutes, this would be expected to be the result of the
`
`obvious combination of Wei, Scholz and Wilkins given the combination yields the
`
`instantly claimed method. Moreover,it is noted that Wei teaches that their composition
`
`possesses antibacterial activity against gram positive bacteria such as S. aureus (see
`
`[0008]).
`
`29. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill
`
`in the art at the time the invention was made, as evidenced by the references, especially
`
`in absence of evidence to the contrary.
`
`30. Claim 122 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
`
`over Weiet al. (US 2002/0098159; ofrecord) in vie w 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, and further in view of Watanabe et al. (Kansenshogaku Azsshi,
`
`1995, 69, abstract).
`
`31. Wei fails to teach the S. aureus as being methicillin resistant.
`
`

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`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 8
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`32. Watanabe teaches that composition of benzalkonium chloride and ethanol are
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`effective at killing methicillin resistant S. aureus. Thus, it would have been obvious to
`
`modify Wei’s method to target such a species with a reasonable expectation for success.
`
`33. Therefore, the invention asa whole is prima facie obvious to one of ordinary skill
`
`in the art at the time the invention was made, as evidenced by the references, especially
`
`in absence of evidence to the contrary.
`
`34. Applicant's amendment necessitated the new ground(s) of rejection presented in this
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`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP§ 706.07(a).
`
`Conclusion
`
`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
`
`35. A shortened statutory period for reply to this final action is set to expire THREE
`
`
`
`MONTHSfrom the mailing date of this action. In the eventafirst reply is filed within TWO
`
`MONTHSof the mailing date of this final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTHshortenedstatutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR 1.136(a) will be calculated from the mailing date of the advisory action.
`
`In no event,
`
`however, will the statutory period for reply expire later than SIX MONTHSfrom the date of this
`
`final action.
`
`36. Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KYLE A PURDYwhosetelephone numberis (571)270-3504.
`
`The examiner cannormally be reached from 9AM to 5PM.
`
`

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`Application/Control Number: 17/083,668
`Art Unit: 1611
`
`Page 9
`
`37. If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`38. 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 (toll-free).
`
`/KYLE A PURDY/
`Primary Examiner, Art Unit 1611
`
`