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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/594,637
`
`10/25/2021
`
`G. Marco Bommarito
`
`81735US004
`
`6502
`
`7590
`200642
`MRG/Solventum
`
`09/05/2024
`
`c/o Mueting Raasch Group
`111 WASHINGTONAVE. S., SUITE 700
`MINNEAPOLIS, MN 55401
`
`EXAMINER
`
`YOUNG, NATASHA E
`
`ART UNIT
`1774
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/05/2024
`
`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):
`
`IPDocketing @ Solventum.com
`ptodocketing @mrgs.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1,3,9,14,16-19,21,27,36,41,43-47,63 and 66-67 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`Claim(s) 1,3,9,14,16-17,19,21,27,36,41,43-47,63 and 66-67is/are allowed.
`Claim(s) 18is/are rejected.
`[) 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)M The drawing(s)filed on 25 October 2021 is/are: a) 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)2) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)() None ofthe:
`b)( Some**
`a) All
`1.1.) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No.
`3.1.) 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 12/20/2021,10/31/2022.
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240831
`
`Application No.
`Applicant(s)
`17/594,637
`Bommarito etal.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`NATASHA E YOUNG
`1774
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof 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 25 October 2021.
`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) 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)(2) 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: 17/594,637
`Art Unit: 1774
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA orAIA Status
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`The presentapplication,filed on or after March 16, 2013, is being examined under the first
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`inventorto file provisions of the AIA.
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b} CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out
`and distinctly claiming the subject matter which the inventor or a jointinventor regards as the
`invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claim 18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second paragraph,as being
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`indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor
`
`or a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the applicant), regards as the
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`invention.
`
`Claim 18 recites the limitation "the two or more channels” in line 2. There is insufficient
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`antecedentbasis for this limitation in the claim.
`
`Allowable Subject Matter
`
`Claims 1, 3, 9,14, 16-17, 19, 21, 27, 36, 41, 43-47, 63, and 66-67 are allowed.
`
`The following isa statement of reasonsfor the indication of allowable subject matter:
`
`The closest prior art references are Witcher et al. (US 7,045,343 B2) and Franciskovich et al. (US
`
`9,017,994 B2).
`
`

`

`Application/Control Number: 17/594,637
`Art Unit: 1774
`
`Page 3
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`Regarding claim1, Witcher et al. discloses a sterilization test pack (80) comprising: a shell
`
`defining an indicator compartment (recess trough, 64) having a volume; achannel(lumen path, 70)
`
`extending between a compartment opening andan exterior opening, the channel(70) being in fluid
`
`communication with the indicator compartment (64) through the compartment opening and
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`surrounding atmospherebeing in fluid communication with the channel (70) through the exterior
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`opening such that the indicator compartment(64)is in fluid communication with the surrounding
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`atmosphere through the channel, the channel(70) having a length measured between the
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`compartment opening and the exterior opening anda hydraulic radius (0.3125 cm) along the length;
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`and an indicator (10) disposedin the indicator compartment (64) (see Abstract; figures 9-10 and
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`column 16,lines 4-67).
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`Witcher etal. fails to disclose or suggest a ratio of the compartment volume to the channel
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`hydraulic radius ranging from 1000 cm? to 8000 cm2.
`
`Claims 3,9, 14, and 16-17 depend onclaim 1.
`
`Regarding claim 19, Witcher et al. discloses a sterilization test pack (80) comprising: a shell
`
`defining an indicator compartment (recess trough, 64) having a volume; achannel(lumen path, 70)
`
`extending between a compartment opening and an exterior opening, the channel(70) being in fluid
`
`communication with the indicator compartment (64) through the compartment opening and
`
`surrounding atmospherebeing in fluid communication with the channel (70) through the exterior
`
`opening such that the indicator compartmentis in fluid communication with the surrounding
`
`atmosphere through the channel (70), the channel (70) having a length measured between the
`
`compartment opening and the exterior opening anda hydraulic radius (0.3125 cm) along the length;
`
`and an indicator (10) disposedin the indicator compartment(see Abstract; figures 9-10 and column 16,
`
`lines 4-67).
`
`

`

`Application/Control Number: 17/594,637
`Art Unit: 1774
`
`Page 4
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`Witcher etal. fails to disclose or suggest that the sterilization test pack exhibiting a diffusivity
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`(LD) of 0.02 cm to 50 cm.
`
`Claims 21, 27, 36, 41, and 43-45 depend on claim 19.
`
`Regarding claim 46, Franciskovich etal. discloses a sterilization test pack (10, 30, 50)
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`comprising: a shelldefining an indicator compartment (recessed compartments, 14 and 16) having a
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`volume; a channel(20, 32, 34) extending between a compartment opening andan exterior opening,
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`the channel(20, 32, 34) being in fluid communication with the indicator compartment (14, 16) through
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`the compartment openingand surrounding atmospherebeingin fluid communication with the
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`channel (20, 32, 34) through the exterior opening such that the indicator compartment(14, 16) is in
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`fluid communication with the surrounding atmosphere through the channel(20, 32, 34), the channel
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`(20, 32, 34) having a length of 1 mm to 25 mm measured between the compartment opening and the
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`exterior opening and amaximum hydraulic radius of 1.0mm or less (1 mm,the shortest length) at any
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`selected location along the length; and an indicator (chemical or biological) disposedin the indicator
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`compartment (14, 16) (see Abstract; figures 1-5 and column 5,lines 32 through column 9,line 55).
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`Franciskovich et al. fails to discloseasterilization test pack comprising: a shell defining an
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`indicator compartmenthaving a volume of 15 cm? to 300 cm; and the channel having a length of 30
`
`mm to 1000 mm measured between the compartment opening and the exterior opening and a
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`maximum hydraulic radius of 1.0mm or less at any selected location along the length.
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`Claims 47, 63 and 66-67 depend on claim 46.
`
`Conclusion
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`Anyinquiry concerning this communication or earlier communications from the examiner
`
`should be directed to NATASHA E YOUNG whose telephone number is (571)270-3163. The examiner can
`
`normally be reached M-F 6:30 am - 6:00 pm.
`
`

`

`Application/Control Number: 17/594,637
`Art Unit: 1774
`
`Page5S
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`
`NATASHAE. YOUNG
`
`Examiner
`
`Art Unit 1774
`
`/NATASHA E YOUNG/
`Primary Examiner, Art Unit 1774
`
`