www.uspto.gov
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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
`
`18/110,242
`
`02/15/2023
`
`Christopher Brian LOCKE
`
`PA001664US18
`
`9788
`
`60402
`
`7590
`
`07/25/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`NGO, MEAGAN N
`
`Para NONE
`
`3781
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/25/2024
`
`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
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-20 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 15-20 is/are withdrawn from consideration.
`[] Claim(s)__ is/are allowed.
`Claim(s) 1-14 is/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 02/15/2023 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
`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 20240717
`
`Application No.
`Applicant(s)
`18/110,242
`LOCKE et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`MEAGAN NGO
`3781
`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 06/18/2024.
`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: 18/110,242
`Art Unit: 3781
`
`Page 2
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`DETAILED ACTION
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`Notice of Pre-AlA or AIA Status
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`The present application, filed on or after March 16, 2013,
`
`is being examined
`
`underthefirst inventor to file provisions of the AIA.
`
`Election/Restrictions
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`Applicant's election without traverse of Group |, claims 1-14 in the reply filed on
`
`06/18/2024 is acknowledged.
`
`Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR
`
`1.142(b) as being drawn to a nonelected invention, there being no allowable generic or
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`linking claim. Election was made without traverse in the reply filed on 06/18/2024.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis forall
`
`obviousness rejections set forth in this Office action:
`
`Apatent fora claimed invention may notbe obtained, notwithstanding thatthe claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior artare suchthat the claimed invention as a whole would have
`been obvious beforethe effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall notbe
`negated by the manner in whichthe invention was made.
`
`The factual inquiries for establishing a background for determining obviousness
`
`under 35 U.S.C. 103 are summarized asfollows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between theprior art and the claims atissue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
`
`Page 3
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`4. Considering objective evidence present in the application indicating
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`obviousness or nonobviousness.
`
`This application currently namesjoint inventors.
`
`In considering patentability of the
`
`claims the examiner presumes that the subject matter of the various claims was
`
`commonly ownedasof the effectivefiling date of the claimed invention(s) absent any
`
`evidenceto the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to
`
`point out the inventor and effective filing dates of each claim that was not commonly
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`ownedas of the effectivefiling date of the later invention in order for the examiner to
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`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2)
`
`prior art against the later invention.
`
`Claims 1-5, 7-8, 11-14 are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Cotton (Pub. No.: US 2014/0309574 A1) in view of Karamietal.
`
`(US Pat. No.: 5,308,313).
`
`Regarding claim 1, Cotton discloses (fig. 13) a dressing (90) for treating a tissue
`
`site with negative pressure (0153), the dressing comprising:
`
`a first layer comprising a manifold (textile material 65);
`
`a second layer comprising a film (sheet of melt-blown polyurethane) and a
`
`plurality of fluid restrictions adjacent to the manifold (see perforations 92, fig. 14,
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`0090); and
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`a third layer (coating of silicone gel 40152, 4 0154) comprising a coating
`
`adjacent to the second layer § 0089-4 0090), wherein a treatment aperture (central
`
`opening, fig. 13) and a plurality of perforations (92) are disposed through the coating ({
`
`0154).
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`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
`
`Page 4
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`Cotton fails to disclose wherein at least a portion of the plurality fluid restrictions
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`are exposed through the treatment aperture.
`
`Karami teaches(fig. 1-4) a dressing (wound dressing 10) and thus in the same
`
`field of endeavor, the dressing comprising a second layer (sheet material 12)
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`comprising a film and a plurality of fluid restrictions (slits 18) (col. 4, In. 57-col. 5,In. 4).
`
`Karami discloses the film and plurality of restrictions spanning the width of the dressing
`
`(fig. 4).
`
`It would have been obvious to oneof ordinary skill in the art before the effective
`
`filing date of the claimed invention to modify the second layer of Cotton such that it
`
`comprises the plurality of fluid restrictions of Karami, thereby providing at least a portion
`
`of the plurality of fluid restrictions exposed through the treatment aperture,
`
`in order to
`
`permit diffusion of wound exudate away from the wound (Karami col. 7, In. 55-58).
`
`Regarding claim 2, Cotton discloses wherein the plurality of perforations are
`
`smaller than the treatment aperture ({ 0154,fig. 13).
`
`Regarding claim 3, Cotton discloses wherein the coating comprises a
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`hydrophobic material (e.g., silicone § 0089).
`
`Regarding claim 4, Cotton discloses wherein the coating comprises a gel (
`
`0089).
`
`0089).
`
`Regarding claim 5, Cotton discloses wherein the coating comprisessilicone ({
`
`Regarding claim 7, Cotton discloses wherein the second layer comprisesa film
`
`of polyurethane ({ 0089-4 0090).
`
`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
`
`Page 5
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`Regarding claim 8, Karami teaches wherein the fluid restrictions compriseslits in
`
`the film (col. 5, In. 3-4).
`
`Regarding claim 11, Cotton in view of Karami fail to teach wherein the treatment
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`aperture has a width in arange of about 90 millimeters to about 110 millimeters and a
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`length in arange of about 150 millimeters to about 160 millimeters.
`
`However, Cotton discloses sizing the treatment aperture such thatit is slightly
`
`smaller in size than the manifold in order to expose the manifold to the wound (4 0154).
`
`Thus, Cotton discloses that the size of the treatment aperture is a result-effective
`
`variable and discovering the optimum or workable rangesinvolvesonly routine skill
`
`in
`
`the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have
`
`been obvious to oneof ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to modify the treatment aperture of Cotton in view of Karami such that
`
`the treatment aperture has a width in a range of about 90 millimeters to about 110
`
`millimeters and a length in a range of about 150 millimeters to about 160 millimeters in
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`order to size the treatment aperture such that the manifold is exposed to the wound.
`
`Absent any showingof critical or unexpected results, such limitations appear to
`
`be routine optimization within the skill of the ordinary artisan before the effectivefiling
`
`date of the invention are therefore prima facie obvious.
`
`Regarding claim 12, Cotton disclose a cover (backing layer 61) disposed over
`
`the manifold (fig. 13), wherein the cover, the manifold, the film and the coating are
`
`assembled in a stackedrelationship (fig. 13) with the coating being configured to face
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`the tissue site (¢ 0154). Further, the modification of Cotton in view of Karami discussed
`
`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
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`Page 6
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`abovein claim 1 provides the portion of the plurality of fluid restrictions exposed through
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`the treatment aperture being configured to face thetissuesite.
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`Regarding claim 13, Cotton discloses wherein the cover comprises a non-porous
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`film (§ 0084) and an adhesive (67, § 0144), the non-porous film coupled around the
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`manifold and the disposed adjacent to the plurality of perforations such that at least
`
`some of the adhesive is exposed through the perforations around the treatment
`
`aperture ({ 0144).
`
`Regarding claim 14, Karami teaches wherein the fluid restrictions are configured
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`to move from a normally restricted position to an open position in response to a
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`pressure gradient (col. 7, In. 25-34).
`
`Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cotton
`
`in view of Karami, as applied to claim 1 above, and further in view of Locke etal.
`
`(Pub. No.: US 2016/0175156 A1).
`
`Regarding claim 6, Cotton discloses wherein the perforations are circular (fig.
`
`14). Cotton in view of Karami fail to teach wherein the perforations have a diameterin a
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`range of about 7 millimeters to about 9 millimeters.
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`Locke teaches(fig. 1) a dressing (124) and thus in the same field of endeavor
`
`comprising a third layer (base layer 132) comprising a plurality of perforations
`
`(apertures160b), wherein the perforations have a diameter in a range of 7.75 mm to
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`about 8.75 mm (4 0050) which falls within the claimed range of between about 7 mm
`
`and 9mm.
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`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
`
`Page 7
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`It would have been obvious to oneof ordinary skill in the art before the effective
`
`filing date of the claimed invention to modify the perforations of Cotton in view of Karami
`
`such that they have a diameter of about 7 mm to about 9mm, as taught by Locke,in
`
`order to configure the dressing to adhere to the epidermis (Locke
`
`0049).
`
`In this case where the claimed ranges “overlap orlie inside ranges disclosed in
`
`the prior art’, a prima facie case of obviousness exists (MPEP §2144.05 |.).
`
`Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Cotton in view of Karami, as applied to claim 8 above, and further in view of Hunt
`
`et al. (Pub. No.: US 2004/0030304 A1).
`
`Regarding claim 9, Cotton in view of Karami fail to teach wherein the slits have a
`
`length in arange of about 2 millimeters to about 5 millimeters.
`
`Hunt teaches (fig. 1) a dressing (wound dressing 10) and thus in the same field
`
`of endeavor, the dressing comprising a layer comprising a plurality of fluid restrictions
`
`(34), the fluid restrictions comprising slits in the film ({ 0033), wherein the slits have a
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`length of between 3 mm and 6 mm ({ 0033) which overlaps with the claimed range of 2
`
`mm to about 5mm.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to modify the slits of Cotton in view of Karami such
`
`that they have a length in a range of about 2 to about 5 mm, as taught by Hunt, in order
`
`to limit ingrowth of fibrous tissue into the film (Hunt § 0015).
`
`In this case where the claimed ranges “overlap orlie inside ranges disclosed in
`
`the prior art’, a prima facie case of obviousness exists (MPEP §2144.05 |.).
`
`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
`
`Page 8
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`Regarding claim 10, Hunt teaches wherein the slits have a length of about 3mm
`
`(4 0033).
`
`Conclusion
`
`The prior art made of record and notrelied upon is considered pertinent to
`
`applicant's disclosure. Locke et al. (Pub. No.: US 2017/0079846 A1) discloses a
`
`dressing comprising a plurality of perforations. Gergely et al. (Pub. No.: US
`
`2012/0095380 A1) discloses a dressing comprising a plurality of perforations. Cotton
`
`(Pub. No.: US 2010/0159192 A1) discloses a dressing comprising a plurality of
`
`perforations.
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to MEAGAN NGO whosetelephone numberis (571)270-
`
`1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
`
`Examinerinterviews 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:/Avwww.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`

`

`Application/Control Number: 18/110,242
`Art Unit: 3781
`
`Page 9
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`
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`
`/MEAGAN NGO/
`Examiner, Art Unit 3781
`
`/SUSAN S$ SU/
`Primary Examiner, Art Unit 3781
`19 July 2024
`
`