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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
`
`16/772,588
`
`06/12/2020
`
`Kelvin J. Witcher
`
`79826US006
`
`8117
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`KANE, TREVOR LOGAN
`
`ART UNIT
`
`1657
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`03/14/2023
`
`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.
`16/772,588
`Examiner
`TREVOR L KANE
`
`Applicant(s)
`Witcheretal.
`Art Unit
`1657
`
`AIA (FITF) Status
`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 1/25/23.
`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*
`1-16 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 8-15 is/are withdrawn from consideration.
`[) Claim(s)__ is/are allowed.
`Claim(s) 1-7 and 16 is/are rejected.
`(1 Claim(s)__is/are objectedto.
`C] 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)() The drawing(s) filedon__ is/are: a)C) accepted or b)C) 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). Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`cc) None ofthe:
`b)L) Some**
`a)D) All
`1.(.) Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have been received in Application No.
`3.2.) 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 20230223
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined underthe
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`first inventorto file provisions of the AJA.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which formsthe basis for all obviousness
`
`rejectionsset forth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed inventionis 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 obviousbefore the effective
`filing date of the claimed invention to a person having ordinaryskill in the art to which the claimed
`invention pertains. Patentability shall not be negated by the mannerin which the invention was made.
`
`This application currently namesjoint inventors. In considering patentability of the
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`claims the examiner presumesthat the subject matter of the various claims was commonly
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`owned asofthe effective filing date of the claimed invention(s) absent any evidenceto the
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`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
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`effective filing dates of each claim that was not commonly ownedasofthe effective filing date
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`of the later invention in order for the examinerto consider the applicability of 35 U.S.C.
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`102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
`
`Maintained rejection. Claims 1-7 and 16 are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Lee (Lee,I., et al. (2016). Antibacterial performance of various amine
`
`functional polymerscoated silica nanoparticles. Polymer, 83, 223-229) in view of Albert
`
`(Albert, H., et al (1998). Biological indicators for steam sterilization: characterization of a rapid
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`biological indicator utilizing Bacillus stearothermophilus spore-associated alpha-glucosidase
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 3
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`enzyme. Journal of applied microbiology, 85(5), 865-874.) and Ghosh (Ghosh,ef al "Surface
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`modification of nano-silica with amides and imides for use in polyester nanocomposites."
`
`Journal of Materials Chemistry A 1.19 (2013): 6073-6080).
`
`Regarding claim 1, Lee teaches surface modification of silica nanoparticles with amines
`
`(abstract). Lee teaches tertiary amine-modified silica nanoparticles and using those nanoparticles
`
`in a liquid medium containing waterto kill the bacteria (p 224 right column lines 4-19, p224
`
`right column lines 32-39, and figure 1). Lee further teaches that the tertiary amine-modified
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`silica nanoparticles are able to kill both gram positive and gram-negative bacteria (abstract,
`
`figure 5 and 6, p227 left column lines 5-10). Examiner notes claim 1 contains the limitation of an
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`organic solvent, if present. Examinerhasinterpreted this to mean that organic solvent can be
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`lacking from the composition. Lee teaches that the nanoparticles are in distilled water (liquid
`
`medium) whichis inherently free of organic solvent and thus meets the limitation on an “organic
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`solvent, if present” (p 224 right columnlines 4-19).
`
`Lee fails to teach an indicator compoundorexplicitly teach that the amine groups are
`
`covalently attached to the silica nanoparticle surface.
`
`Albert teaches biological indicators for sterilization (title). Albert teaches that
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`sterilization monitoring is important to ensure adequate sterilization and that biological
`
`indicators are the most effective method (p865 left column lines 14-16). Albert teaches using a-
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`glucosidase for a spectrophotometric measurementusing p-nitrophenyl-alpha-D-glucoside
`
`(PNPG)as an indicator compoundas a read outforsterilization of spore forming bacteria (p866
`
`left column lines 27-34, p867 left column lines 15-43). Albert teaches that o-glucosidaseis a
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`useful predictor of spore survival as it is present in both viable and vegetative cells and the
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`

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`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 4
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`enzymesurvives just longer than the spore following the sterilization (p872 right column lines
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`17-20).
`
`Lee and Albert fail to teach that the amine groups are covalently attached to the silica
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`nanoparticle surface.
`
`Ghoshteaches surface modification of silica nanoparticles with primary amines
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`(abstract). Ghosh teaches that there are different ways to bind APS (primary amine)to the silica
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`nanoparticle and that a covalent bondis the strongest (p6075 left column lines 37-40,figure 1).
`
`It would have been obvious to one of ordinary skill in the art before the effective filing
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`date of the claimed invention to modify the anti-bacterial composition containing tertiary amine
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`silica nanoparticle of Lee by adding the indicator compoundof Albert and generating the tertiary
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`aminesilica nanoparticle through covalent bondsas taught by Ghosh. One ofordinary skill in
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`the art would be motivated to do so because Albert teaches the utility of using indicators for
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`killing bacteria. One of ordinary skill would be further motivated to generate the tertiary amine
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`silica nanoparticles using the covalent bond method of Ghosh as Ghoshteaches that a covalent
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`bond results in the strongest amine modified silica nanoparticles. There would be a reasonable
`
`expectation of success as both Lee and Albert are in the same field of endeavorofkilling
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`bacteria and Lee and Ghoshare in the samefield of endeavor of amine surface-modified silica
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`nanoparticles.
`
`Regarding claims 2 and 3, Lee teaches contacting tertiary amine-nanoparticles with the
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`bacterial strains E. coli and S. aureus (bacteria) (p224 right column lines 33-39).
`
`Regarding claim 4, while Lee teaches bacteria, Lee fails to teach spore forming bacteria.
`
`However, Albert teaches the use of the spore forming bacterium Bacillus stearothermophilus to
`
`measuresterilization (abstract, p866 left columnlines 29-32).
`
`

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`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 5
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`Regarding claims 5 and 6, Albert teaches using a-glucosidase for both a
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`spectrophotometric measurement using p-nitrophenyl-alpha-D-glucoside (PNPG) and a
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`fluorimetric detection using 4-methylumbelliferyl-alpha-D-glucoside (4-MUG)(p867left
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`column lines 15-43). Readout of the p-nitrophenol from the substrate p-nitrophenyl-alpha-D-
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`glucoside after cleavage by a-glucosidase was monitored at 410 nm (p867 left columnlines 18-
`
`21). One of ordinary skill in the arts would recognize that 410 nm correspondsto a color.
`
`Regarding claim 7, Lee teachestertiary amine-modified silica nanoparticles and using
`
`those nanoparticles in a liquid medium containing waterto kill the bacteria (p 224 right column
`
`lines 4-19, p224 right columnlines 32-39, and figure 1). Lee does not teach the covalent
`
`attachmentof the tertiary amine groups to the surface of the silica nanoparticles. However,
`
`Ghoshteachesthat there are different ways to bind APS (primary amine)to the silica
`
`nanoparticle and that a covalent bondis the strongest (p6075 left column lines 37-40, figure 1).
`
`Ghoshfurther teaches a variety of functional groups are able to be attached covalently to the
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`silica nanoparticle (figure 1).
`
`Regarding claim 16, Ghoshteachesthat the reaction between the silica nanoparticle and
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`the amineresults in a Si-O-Si bond (p6074 left columnlines 3-8, figure 1).
`
`Response to Arguments
`
`Applicant's arguments filed 1/25/23 have been fully considered but they are not
`
`persuasive. Applicant argues surprising results, the claimed combination results in enhanced
`
`fluorescent signal and reaction speed (p5 last paragraph-p6 first paragraph). Regarding the
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`enhanced fluorescence, MPEP 716.01(c) makesclear that arguments of counsel cannot take the
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`place of evidence in the record. Regarding the increased reaction speed, MPEP 2145states that
`
`

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`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 6
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`although the claimsare interpreted in light of the specification, limitations from the specification
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`are not read into the claims.
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`Applicant argues that Albert does not teach using indicators to kill bacteria (p6 second
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`paragraph). The argumentsofthe utility of Albert’s biological indicators do not pertain to any
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`claim limitation. Albert teachesthat sterilization is the act of destroying or eliminating all forms
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`of life (killing) (p865 left column lines 2-4). Thus, Albert is in the same field of endeavor as Lee
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`as indicated abovein the rejection of claim 1.
`
`No claimsare allowed
`
`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
`
`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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`MONTHSof the 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
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
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`however,will the statutory period for reply expire later than SIX MONTHSfrom the mailing
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`date of this final action.
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to TREVOR L KANEwhosetelephone numberis (571)272-0265.
`
`The examiner can normally be reached M-F 7:00 am-4:00pm.
`
`

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`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 7
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`Examinerinterviews are available via telephone, in-person, and video conferencing using
`
`a USPTO supplied web-based collaboration tool. To schedule an interview, applicantis
`
`encouraged to use the USPTO Automated Interview Request (AIR) at
`
`http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examinerby telephone are unsuccessful, the examiner’s
`
`supervisor, Louise Humphrey can be reached on (571)272-5543. The fax phone numberfor the
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`organization wherethis application or proceedingis assigned is 571-273-8300.
`
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`
`obtained from Patent Center. Unpublished application information in Patent Centeris available
`
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`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/LOUISE W HUMPHREY/
`Supervisory Patent Examiner, Art Unit 1657
`
`/TREVOR L KANE/
`Examiner, Art Unit 1657
`
`