`geste
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`KINETIC CONCEPTS, INC.
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`LEVY, BRANDON WILLIAM
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`3781
`DATE MAILED:09/11/2024
`
`17/631,923
`
`02/01/2022
`
`Christopher Brian LOCKE
`
`PA01697US04
`
`1347
`
`TITLE OF INVENTION: NEGATIVE-PRESSURE SYSTEM INCORPORATING WOUNDDIAGNOSTIC CAPABILITIES
`
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONFIRMATIONNO.
`
`Christopher Brian LOCKE
`02/01/2022
`17/631,923
`TITLE OF INVENTION: NEGATIVE-PRESSURE SYSTEM INCORPORATING WOUNDDIAGNOSTIC CAPABILITIES
`
`PA01697US04
`
`1347
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
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`3781
`LEVY, BRANDON WILLIAM
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`UNITED STATES DEPARTMENT OF COMMERCE
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`APPLICATION NO.
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`FILING DATE
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`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATIONNO.
`
`17/631,923
`
`02/01/2022
`
`Christopher Brian LOCKE
`
`PA01697US04
`
`1347
`
`60402
`
`7590
`
`09/11/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`.
`5445 Corporate Drive
`Suite 200
`Troy, MI 48098
`
`LEVY, BRANDON WILLIAM
`ART UNIT
`PAPER NUMBER
`eeee
`3781
`DATE MAILED:09/11/2024
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
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`

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`4.1) Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c) () Noneofthe:
`a) DAI
`b) (] Some*
`1. (1 Certified copies of the priority documents have been received.
`2. (J Certified copies of the priority documents have been received in Application No.
`3. (J Copiesof the certified copies of the priority documents have been receivedin this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`
`Supervisory Patent Examiner, Art Unit 3781
`
`/NICHOLAS J. WEISS/
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`.
`Part of Paper No./Mail Date 20240827
`
`.
`
`.
`
`171631,923
`
`LOCKE etal.
`
`BRANDON W LEVY
`
`3781
`
`Yes
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`NOTICE OF ALLOWABILITY IS NOT A GRANTOF PATENTRIGHTS.This application is subject to withdrawal from issue at the initiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`1{¥] This communication is responsive to 08/20/2024.
`(J A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`.
`
`2._) Anelection was madeby the applicant in responseto a restriction requirement set forth during the interview on
`restriction requirement and election have been incorporatedinto this action.
`
`; the
`
`3.¥) The allowed claim(s) is/are 1,3-10 and 24-31 . As a result of the allowed claim(s), you may beeligible to benefit from the Patent
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information
`, please see hitp:/Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
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`* Certified copies not received:
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`Applicant has THREE MONTHS FROM THE "MAILING DATE"of this communication to file a reply complying with the requirements
`noted below.Failure to timely comply will result in ABANDONMENT ofthis application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5.) CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`(} including changes required by the attached Examiner's Amendment / Commentor in the Office action of
`Paper No./Mail Date
`.
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawingsin the front (not the back) of each
`sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6.LJ DEPOSIT OFand/or INFORMATION aboutthe deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`
`1.[¥] Notice of References Cited (PTO-892) 5.YjExaminer's Amendment/Comment
`2.C Information Disclosure Statements (PTO/SB/08),
`6.
`Examiner's Statement of Reasons for Allowance
`Paper No./Mail Date
`.
`3.) Examiner's Comment Regarding Requirementfor Deposit
`of Biological Material
`4.C] Interview Summary (PTO-413),
`Paper No./Mail Date.
`/Brandon W. Levy/
`Examiner, Art Unit 3781
`
`7. CZ Other
`
`.
`
`

`

`Application/Control Number: 17/631,923
`Art Unit: 3781
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined under the first
`
`inventor to file provisions of the AIA.
`
`Continued Examination Under 37 CFR 1.114
`
`2.
`
`A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR
`
`1.17(e), was filed in this application after final rejection. Since this application is eligible for continued
`
`examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the
`
`finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's
`
`submission filed on 08/20/2024 has been entered.
`
`An amendment was filed on 08/20/2024. Claim 1 was amended. Currently claims 1, 3-10, 24-31,
`
`34, 36, 38, 47, and 52 are pending, with claims 5-6, 8, 10, 25-31, 34, 36, 38, 47, and 52 being withdrawn
`
`as part of a restriction made without traverse.
`
`Election/Restrictions
`
`3.
`
`Claim 1 is allowable. The restriction requirement between claims 1, 3-12, 14, 17, and 24-31
`
`(Group 1), 34, 36, and 38 (Group II), and 47 and 52 (Group III), with Species between Claims 4, 5, and 6,
`
`and betweenclaims 7, 8, and 10, as set forth in the Office action mailed on 05/22/2023, has been
`
`reconsideredin view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a).
`
`The restriction requirementis hereby withdrawnas to anyclaim that requiresall the limitations of an
`
`allowable claim. Specifically, the restriction requirement of 05/22/2023is partially withdrawn. Claims
`
`5-6, directed to the volatile compound being detected being a protease component(claim 5) or a matrix
`
`metalloproteinase component(claim 6), as well as claims 7-10 drawnto various gas sensors(claim 7), a
`
`FAIMS sensor (claim 8), and a metal-oxide semiconductor sensor (claim 10), and claims 30-31 relating to
`
`the non-healing wound condition indicated by predetermined high proteaseactivity level (claim 30) and
`
`

`

`Application/Control Number: 17/631,923
`Art Unit: 3781
`
`Page 3
`
`the instillation source (claim 31), are no longer withdrawn from consideration becausethe claim(s)
`
`requiresall the limitations of an allowable claim. However, claims 34, 36, 38, 47, and 52, directed toa
`
`canister for collecting fluid from a tissue site (claims 34 and 36), a method for sampling a fluid form a
`
`tissue site (claim 47 and 52), remain withdrawn from consideration because they do not require all the
`
`limitations of an allowable claim.
`
`In view of the above noted withdrawal of the restriction requirement, applicant is advised thatif
`
`any claim presentedin a divisional application is anticipated by, or includesall the limitations of, a claim
`
`that is allowable in the present application, such claim may be subject to provisional statutory and/or
`
`nonstatutory double patenting rejections over the claims of the instant application.
`
`Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer
`
`applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP §
`
`804.01.
`
`merits.
`
`To summarize, claims 5-6 are being rejoined, and claims 1, 3-10, 24-31 are all examined on the
`
`EXAMINER’S AMENDMENT
`
`4.
`
`An examiner’s amendmentto the record appears below. Should the changes and/or additions
`
`be unacceptable to applicant, an amendment maybefiled as provided by 37 CFR 1.312. To ensure
`
`consideration of such an amendment, it MUST be submitted no later than the paymentofthe issue fee.
`
`5.
`
`As noted above, claims 34, 36, 38, 47, and 52 are considered withdrawn from consideration
`
`becausethey do not requireall the limitations of an allowable claim. Because the election was made
`
`without traverse, claims 34, 36, 38, 47, and 52 are canceled.
`
`Allowable Subject Matter
`
`6.
`
`Claims 1, 3-10, 24-31 are allowed.
`
`The following is an examiner’s statement of reasons for allowance:
`
`

`

`Application/Control Number: 17/631,923
`Art Unit: 3781
`
`Page 4
`
`7.
`
`Regarding claim 1, the closest prior art of record, Tumey (US 20020143286) discloses a system
`
`for treating a tissue site, comprising:
`
`a dressing adapted to be placed on the tissue site
`
`a negative-pressure source adapted to befluidly coupled to the dressing and to the negative-
`
`pressure source and to receive fluid from the tissue site
`
`a sensor module adapted to be exposed to gas associated with the fluid from the tissue site,
`
`wherein the sensor module comprisesa first sensor configured to detect a condition of the tissue site
`
`and to generate a first output based on the detected condition.
`
`The embodiment of Tumeyin fig. 1 is silent to a container having a fluid inlet adapted to be
`
`fluidly coupled to the dressing, a fluid outlet adapted to be fluidly coupled to the negative pressure
`
`source, and a collection chamber to receive fluid from the tissue site, a sensor compartment disposed
`
`within the container between the collection chamber and the fluid outlet, the sensor compartment
`
`having a fluid pathway fluidly coupled to the fluid outlet and a purge pathway configured to be fluidly
`
`coupled to an ambient environment, wherein the sensor module is removably positioned in the sensor
`
`compartment, a transceiver electrically coupled to the sensor module and configured to transmit the
`
`first output from the sensor module to a controller configured to receive the first output from the
`
`transceiver to generate a notification, wherein the transceiver transmits the output to a controller to
`
`generate a data entry based on the detected condition, and in response to the detected condition,
`
`adjust a provided therapy.
`
`The embodiment of Tumeyin fig. 2 teaches a container adapted to be fluidly coupled to the
`
`dressing and to the negative pressure source and to receive fluid from the tissue site
`
`Braga (US 20100049150) teaches a sensor with electrical contact protection in a collection
`
`canister for negative pressure wound therapy wherein the container comprises a sensor compartment
`
`

`

`Application/Control Number: 17/631,923
`Art Unit: 3781
`
`Page 5
`
`with the sensor module, butfails to teach wherein the compartment has a fluid pathway fluidly coupled
`
`to the fluid outlet and a purge pathway configured to be fluidly coupled to an ambient environment.
`
`Charlez (US 20100174270) teaches a pleural drainage device that has the container with a
`
`pathwayeither to the vacuum or to the ambient atmosphere, but does notfairly teach a compartment
`
`for the sensor between the collection chamber and the fluid outlet.
`
`Fink (US 20130066349) teaches wherein an output from a gas sensor is digitally recorded, thus
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`creating a data entry, but fails to cure the above deficiencies of the compartment.
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`Bernstein (US 20100150991) teachesthe use of a topical treatment during NPWTif a bacteria is
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`detected, wherein the controller can be used to control the timing of when the topical medicine is
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`applied, including to when bacteria is detected.
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`Hartwell (WO 2017197357) discloses the use of a transceiver to receive and send out data in
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`conjunction with a sensor.
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`Even assuming making the sensor module removably position in the sensor compartment would
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`have been obvious, the prior art of record fails to teach a sensor compartment disposed within the
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`container between the collection chamber and the fluid outlet, the sensor compartment having a fluid
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`pathwayfluidly coupled to the fluid outlet and a purge pathway configured to be fluidly coupled to an
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`ambient environment. For these reasons, claim 1 is allowable.
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`8.
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`9.
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`The remaining claims are allowable by virtue of being dependent on claim 1.
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`Any comments considered necessary by applicant must be submitted no later than the payment
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`of the issue fee and, to avoid processing delays, should preferably accompanythe issue fee. Such
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`submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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`

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`Application/Control Number: 17/631,923
`Art Unit: 3781
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`Page 6
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to BRANDON W LEVY whosetelephone number is (571)272-7582. The examiner can
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`normally be reached M-F 8:00 AM- 4:30 PM.
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`Examiner interviewsare available via telephone, in-person, and video conferencing using a
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Nicholas Weiss can be reached on (571) 270-1775. The fax phone number for the organization where
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`this application or proceedingis assigned is 571-273-8300.
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`Information regarding the status of published or unpublished applications may be obtained from
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`/Brandon W. Levy/
`Examiner, Art Unit 3781
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`Supervisory Patent Examiner, Art Unit 3781
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`/NICHOLASJ. WEISS/
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`