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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
`
`04/22/2022
`
`ELECTRONIC
`
`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.
`
`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)
`
`

`

`Application No.
`Applicant(s)
`16/772 588
`Witcheretal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`TREVOR L KANE
`1657
`Yes
`
`
`
`-- The MAILING DATEofthis 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 3/15/22.
`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*
`1-15 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 8-15 is/are withdrawn from consideration.
`1) Claim(s)__ is/are allowed.
`Claim(s) 1-7 is/are rejected.
`)
`Claim(s) 6 is/are objectedto.
`O Claim(s
`are subject to 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)CL) The specification is objected to by the Examiner.
`11)0) 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)C) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)LJ None of the:
`b)L) Some**
`a)LJ} All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.0.) 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) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20220418
`
`

`

`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
`
`first inventor to file provisions of the AIA.
`
`Response to Amendment
`
`This action is written in response to applicant’s correspondence received on 3/15/22.
`
`Amended claims 1-7 are under examination.
`
`Any rejection or objection not reiterated herein has been overcome by amendment.
`
`Claim rejections under 35 USC § 112(b) are withdrawn.
`
`Claim Objections
`
`Claim 6 is objected to because of the following informalities:
`
`claim 6 recites “selected
`
`from the list of consisting of’ in line 2, which is grammatically incorrect, and should be amended
`
`to “selected from the group consisting of” using Markush group formatting. Furthermore, the
`
`group of enzymes recited in claim 6 contains two non-enzymes, butyrate and arabinoside.
`
`Examiner recommendsdeleting the non-enzyme members from the list of enzymes. Appropriate
`
`correction is required.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which formsthe basis for all obviousness
`
`rejections set forth in this Office action:
`
`A patent fora 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 theclaimed invention as a whole would have been obviousbefore the effective
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 3
`
`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.
`
`The factual inquiries for establishing a background for determining obviousness under 35
`
`U.S.C. 103 are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims atissue.
`
`3. Resolving the level of ordinary skill
`
`in the pertinent art.
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`4, Considering objective evidence present in the application indicating obviousness or
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`nonobviousness.
`
`This application currently names jomt inventors. In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was commonly
`
`ownedasof the effective filing date of the claimed invention(s) absent any evidence to 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 eachclaim that was not commonly ownedasofthe effective filing date
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`of the later invention in order for the examiner to 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.
`
`Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee, I.,
`
`Roh, J., Lee, J., Song, J., & Jang, J. (2016). Antibacterial performance of various amine
`
`functional polymers coatedsilica nanoparticles. Polymer, 83, 223-229), and further in view of
`
`Albert (Albert, H., Davies, D. J. G., Woodson, L. P., & Soper, C. J. (1998). Biological
`
`indicators
`
`for steam sterilization: characterization of a rapid biological
`
`indicator utilizing Bacillus
`
`stearothermophilus spore-associated alpha-glucosidase enzyme. Journal of applied
`
`microbiology, 85(5), 865-874.).
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 4
`
`Regarding claim 1, 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 silica nanoparticles are able to kill both gram positive and gram negative
`
`bacteria by damaging the membrane(abstract, figure 5 and 6, p227 left column lines 5-10)
`
`Examiner notes claim 1 contains the limitation of an organic solvent, if present. Examiner has
`
`interpreted this to mean that organic solvent canbe lacking from the composition. Leestates that
`
`the nanoparticles are in distilled water which is inherently free of organic solvent and thus meets
`
`the limitation on an “organic solvent, if present” (p 224 right column lines 4-19).
`
`Lee fails to teach an indicator compound.
`
`Albert teaches that 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 that using spores as biological
`
`indicators is ideal because when the spores are
`
`killed it is likely that other organisms will have been killed as well due to the high resistance
`
`spores haveto sterilization (p865 left column lines 17-18- right column lines 1-5). Albert teaches
`
`using a-glucosidase for a spectrophotometric measurement using p-nitrophenyl-alpha-D-
`
`glucoside (PNPG)as an indicator compound asaread out for sterilization of spore forming
`
`bacteria (p866 left column lines 27-34, p867 left column lines 15-43). Albert teaches that a-
`
`glucosidase is a useful predictor of spore survival asit is present in both viable and vegetative
`
`cells and the enzyme survives just longer than the spore following thesterilization (p872 right
`
`column lines 17-20). Albert further teaches that a-glucosidase canbe found in a variety of
`
`organisms including microorganisms, animals and plants (p866 left column lines 45-47).
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 5
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`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 method ofkilling bacteria found in Lee with the
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`detection method consisting of indicator compound, enzyme a-glucosidase, and spore forming
`
`bacteria as taught in Albert to ensure bacteria have been killed. One of ordinary skill
`
`in the art
`
`would be motivated to do so because Albert provides a method of using biological
`
`indicators to
`
`ensure bacteria have been killed. There would be a reasonable expectation of success as both
`
`Lee and Albert are in the same field of endeavor of sterilization or antimicrobial
`
`technology.
`
`Albert teaches that o-glucosidase is found in a variety of organisms and thus would be a useful
`
`indicator to measure cellular death. Lee taught that tertiary amine-modified silica nanoparticles
`
`are able to kill both gram positive and negative bacteria. One of ordinary skill in the arts would
`
`expect that the tertiary amine-modified silica nanoparticles as taught in Lee would therefore be
`
`able to kill a wide variety of cells and that as a-glucosidase are found in a wide range of species
`
`as taught by Albert, the combination of Lee and Albert would have a reasonable expectation of
`
`SsuCCESS.
`
`Regarding claims 2 and 3, Lee teaches contacting tertiary amine-nanoparticles with the
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`bacterial strains E. coli and S. aureus (p224 right column lines 33-39).
`
`Regarding the embodiment of claims 2 and 3 in which the composition further
`
`encompasses cells or enzymes, the obviousness of combining a-glucosidase and indicator
`
`compound as taught by Albert with the composition of Lee is discussed above as applied to
`
`claim 1.
`
`Regarding claim 4, while Lee teaches bacteria, Lee fails to teach spore forming bacteria.
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 6
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`Albert teaches the use of the spore forming bacterium Bacillus stearothermophilus to
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`measuresterilization (abstract, p866 left column lines 29-32).
`
`Regarding the embodiment of claim 4 in which the composition further encompasses
`
`spore forming bacteria, the obviousness of combining a-glucosidase and indicator compound as
`
`taught by Albert with the composition of Lee is discussed above as applied to claim 1.
`
`Regarding claims 5 and 6, Albert teaches using a-glucosidase for both a
`
`spectrophotometric measurement using p-nitrophenyl-alpha-D-glucoside (PNPG) anda
`
`fluorimetric detection using 4-methylumbelliferyl-alpha-D-glucoside (4-MUG) (p867 left
`
`column lines 15-43). Readout of the p-nitrophenol from the substrate p-nitrophenyl-alpha-D-
`
`glucoside after cleavage by a-glucosidase was monitored at 410 nm (p867 left column lines 18-
`
`21). One of ordinary skill
`
`in the arts would recognize that 410 nm correspondsto a color.
`
`Regarding the embodiment of claims 5 and 6 in which the composition further
`
`encompasses a chromogenic substrate and enzyme, the obviousness of combining a-glucosidase
`
`and indicator compound astaught by Albert with the composition of Leeis discussed above as
`
`applied to claim 1.
`
`Regarding claim 7, Lee teaches that the tertiary amine-functionalized silica
`
`nanoparticles are obtamed after polymerization IE formation of covalent bonds (p225 left
`
`column lines 28-30).
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 7
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`Response to Arguments
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`Applicant's arguments filed on 3/15/22 have been fully considered but they are not
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`persuasive. Applicant (Remarks p11-12) argues that it would be surprising for the combination
`
`of an amine-functionalized nanoparticles and an indicator will result in higher fluorescence
`
`readout rather than the indicator alone. In the 103 rejection above where an amine-functionalized
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`nanoparticle is combined with an indicator for cell death, one would expect that, in cases where
`
`the nanoparticle is killing the cell coupled with the indicator for cell death, a higher level of
`
`fluorescence would be obtained. In a case where only the indicator is present, there would be low
`
`level of fluorescence as there is not an agent killing the cells.
`
`Applicant further argues that the composition of Albert would not be used in conjunction
`
`with the nanoparticles of Lee becausekilling the cell would result in lower detection of the
`
`metabolic activity of the cells. By combining the killing method of Lee with the detection
`
`method of Albert consisting of an indicator compound,
`
`the enzyme a-glucosidase and spore
`
`forming bacteria, the benefit is to ensure that bacteria have been killed.
`
`In other words, no
`
`bacteria should be detected if they wereall killed as the method of Lee intends. Oneof ordinary
`
`skill would expect very low signal as a measurementto ensure that bacteria have beenkilled.
`
`The claims that are directed towards the metabolic activity of cells claims 13-14 were withdrawn
`
`and not examined.
`
`In response to applicant's argumentthat the references fail to show certain
`
`features of applicant’s invention,
`
`it is noted that the features upon which applicant relies (1e.,
`
`detecting metabolic activity of cells, applicant arguments p12) are not recited in the rejected
`
`claim(s). Although the claims are interpreted in light of the specification,
`
`limitations from the
`
`specification are not read into the claims. See In re Van Geuns,988 F.2d 1181, 26
`
`USPQ2d 1057 (Fed. Cir. 1993).
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 8
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`No claimsare allowed.
`
`Conclusion
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
`
`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
`
`MONTHSfrom the mailing date of this action.
`
`In the eventa first 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 mailing
`
`date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to TREVOR L KANEwhose telephone numberis (571)272-0265.
`
`The examiner cannormally be reached M-F 7:00 am-4:00pm.
`
`Examiner interviews are available via telephone, in-person, and video conferencing using
`
`a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is
`
`encouraged to use the USPTO Automated Interview Request (AIR) at
`
`http://www.uspto. gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Louise Humphrey can be reached on (571)272-5543. The fax phone number for the
`
`organization wherethis application or proceeding is assigned is 571-273-8300.
`
`

`

`Application/Control Number: 16/772,588
`Art Unit: 1657
`
`Page 9
`
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`
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`
`/LOUISE W HUMPHREY/
`Supervisory Patent Examiner, Art Unit 1657
`
`/TREVORL KANE/
`Examiner, Art Unit 1657
`
`