`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`09/24/2021
`
`Christopher Brian LOCKE
`
`P001742US02PCT
`
`7319
`
`EXAMINER
`
`TRAN, NHU
`
`3781
`
`11/27/2023
`
`ELECTRONIC
`
`17/442,815
`
`60402
`
`7590
`
`11/27/2023
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 300
`
`Troy, MI 48098
`
`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):
`
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`
`
`Office Action Summary
`
`Application No.
`17/442,815
`Examiner
`NHU Q TRAN
`
`Applicant(s)
`LOCKE etal.
`Art Unit
`3781
`
`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 08/18/2023.
`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.
`
`1,4-6,10,12,18-19,22,31,35,45-46,51,53,55-56,58,61,65-67 and 69-70 is/are pending in the
`
`
`
`Disposition of Claims*
`5)
`Claim(s)
`application.
`is/are withdrawn from consideration.
`5a) Of the above claim(s)
`(9 Claim(s) _ is/are allowed.
`Claim(s) 1,4-6,10,12,18-19,22,31,35,45-46,51,53,55-56 ,58,61,65-67 and 69-70 is/are rejected.
`CG Claim(s) _ is/are objectedto.
`8)
`9) © 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.
`
`) ) ) )
`
`6 7
`
`Application Papers
`10)C The specification is objected to by the Examiner.
`11) The drawing(s) filed on 09/24/2021 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)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)D) None ofthe:
`b)7) Some**
`a)D All
`1.1) Certified copies of the priority documents have been received.
`2.) 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 20231118
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 2
`
`DETAILED CORRESPONDENCE
`
`Note: This office action is in response to communication filed on 08/18/2023.
`
`Notice of Pre-AlA or AIA Status
`
`The present application, filed on or after March 16, 2013,
`
`is being examined
`
`under the first inventor to file provisions of the AIA.
`
`Status of Claims
`
`Claim(s) 1, 4-6, 10, 12, 18-19, 22, 31, 35, 45-46, 51, 53, 55-56, 58, 61, 65-67,
`
`and 69-70is/are pending in the application.
`
`Claim(s) 1, 4-6, 10, 12, 18-19, 22, 31, 35, 45-46, 51, 53, 55-56, 58, 61, 65-67,
`
`and 69-70 is/are examined on the merits.
`
`Response to Arguments
`
`Applicant’s arguments filed on 08/18/2023 have beenfully considered but are
`
`moot because the independent claims have been amended and the new ground of
`
`rejection does not rely on the same combination references applied in the prior rejection
`
`of record for any teaching or matter specifically challenged in the argument.
`
`With respect to the claim objection(s), applicant's amendment(s) to the claim(s)
`
`has/have overcome the objection(s).
`
`With respect to the claim rejection(s) under 35 U.S.C. § 112(b), applicant's
`
`amendment(s) to the claim(s) has/have overcome the claim rejection(s).
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
`
`correction of the statutory basis for the rejection will not be considered anew groundof
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 3
`
`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
`
`the same under either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`A patent for a 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 the claimed invention as a whole would have been obvious
`
`before the effectivefiling 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 asfollows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating
`
`obviousness or nonobviousness.
`
`Claim(s) 1, 4-6, 10, 12, 18-19, 22, 31, 35, 45-46, 53, 55, 61, 66-67, and 69
`
`is/are rejected under 35 U.S.C 103 as being unpatentable over Locke (US PGPUB
`
`20180353662 — of record) in view of Collinson (US PGPUB 20160144084).
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 4
`
`Regarding claim 1, Locke discloses a dressing (a dressing 102: 40030 and Fig.
`
`2) for treating a tissue site with negative pressure (Abstract and 40030), the dressing
`
`(102) comprising:
`
`a cover (a cover 106: 40030 and Fig. 10) comprising a first aperture (an aperture
`
`294: YO080 and Fig. 10);
`
`a first polymerfilm (a third layer 220 is formed of a polyurethane film: 0086 and
`
`Fig. 2) comprising a plurality of standoffs (blister 270: §0068, Figs. 2, and 6-7); and
`
`a second polymer film (a second layer 210 comprises a non-porous polymerfilm:
`
`40060 and Fig. 2) disposed adjacent to the standoffs in the first polymer film (the
`
`standoffs 270 protrude towards or face the second film 210: 40068 and Fig. 2; thus, 210
`
`is disposed adjacent to the standoffs 270), the second polymerfilm (210) including a
`
`plurality of fluid restrictions (fluid restrictions 260: (0065 and Fig. 2).
`
`Lockefurther discloses the first polymerfilm comprising a second aperture
`
`(0068 and Fig. 2: the first polymerfilm 275 comprising a plurality of apertures 275 to
`
`allow fluid transfer through the film; thus, one of the apertures 275 reads on the second
`
`aperture of the first film); however, Locke does not disclose the second aperture axially
`
`aligned with the first aperture in the cover.
`
`In the same field of endeavor, wound dressings, Collinson discloses a wound
`
`dressing 3900 (0140 and Figs. 4C-D) comprising an obscuring layer 3920, an absorbent
`
`layer 3930, acquisition distribution layer 3940, a transmission layer 3950, and a cover (a
`
`backing layer 3910: 40140 and Fig. 4D). Collinson further teaches the cover 3910
`
`comprising an opening 3911 and each of the layers 3920/3930/3940 comprising openings
`
`3921/3931/3941 and wherein all openings are aligned to each other and underlying a port
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 5
`
`3990 ((0141 and Fig. 4D) for the benefit of allowing the negative pressure applied to the
`
`port to be communicated directly to the transmission layer without passing through other
`
`layers (0117 and 0141). From these teachings, a person having ordinary skill
`
`in the art
`
`would have recognized/deduced that arranging the second aperture on the first polymer
`
`film so that the second aperture is axially aligned with the first aperture yields the
`
`predictable
`
`result
`
`of allowing
`
`the negative pressure
`
`applied to the port
`
`to be
`
`communicated directly to the second polymer film without passing through thefirst
`
`polymerfilm.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the first polymer film of Locke in
`
`view Collinson by axially aligning the second aperture with the first aperture in the
`
`cover, in order to allow the negative pressure applied to a port to be communicated
`
`directly to the second polymer film without passing through the first polymerfilm, as
`
`suggested in 90117 and 0141 of Collinson and as it has been held that a mere
`
`rearrangement of element without modification of the operation of the device involves
`
`only routine skill in the art (See MPEP § 2144.04 (VI) (C)). In addition, a person having
`
`ordinary skill in the art would have motivated to rearrange the second aperture on the
`
`first polymer film to be axially aligned with the first aperture of the cover to facilitate
`
`delivery of negative pressure to the wound dressing.
`
`Regarding claim 4, Locke further discloses the first polymer film and the second
`
`polymerfilm allow visualization of the tissue site (220 and 210 comprise transparent
`
`materials to allow visualization of the tissue site to a user throughout the wear duration
`
`of the dressing: 70106).
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 6
`
`Regarding claim 5, Lockefurther discloses the plurality of standoffs forma
`
`plurality of spaces between thefirst polymer film and the second polymerfilm (the
`
`standoffs 270 protrude towards or face the secondfilm 210 and is formed of raised
`
`formations: 0068 and Figs. 6-7; thus, the standoffs 270 form a plurality of spaces
`
`between the first film 220 and the secondfilm 210).
`
`Regarding claim 6, Locke and Collinson disclose the claimed invention except
`
`for the rearrangement of the standoffs and the fluid restrictions.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the wound dressing of Locke and
`
`Collinson by rearranging the standoffs and the fluid restrictions so that at least some of
`
`the standoffs are offset from the fluid restrictions, as it has been held that a mere
`
`rearrangement of element without modification of the operation of the device involves
`
`only routine skill in the art (See MPEP § 2144.04 (VI) (C)). One would have been
`
`motivated to rearrange rearranging the standoffs and the fluid restrictions so that at
`
`least some of the standoffs are offset from the fluid restrictions forthe purpose of
`
`improving negative pressure therapeutic effect. Further, Applicant places no criticality
`
`on the arrangementof the standoffs and the fluid restrictions,
`
`indicating simply that at
`
`least some of the standoffs may be offset from the fluid restrictions (¢0010 and 0087 of
`
`instant specification).
`
`Regarding claim 10, Locke further discloses the first polymer film (220) further
`
`comprises apertures (apertures 275: 40068, Figs. 2, and 7) formed in portions of the
`
`first polymer film between the standoffs (apertures 275 is formed in the portions of the
`
`first film 220 that are between the standoffs 270: 40087 and Fig. 7).
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 7
`
`Regarding claim 12, Locke further discloses the first polymer film (220) further
`
`comprises apertures (aperture 275: 40087 and Fig. 7) adjacent to the standoffs (0087
`
`and Fig. 7), the apertures having a width in a range of 0.5 millimeters to 1.5 millimeters
`
`(the apertures 275 have a length between about 0.5 mm and 2.0 mm: 40087; thus, the
`
`taught width range overlaps the claimed width range).
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`by selecting the width of the apertures within the claimed range as it has been held that
`
`a prima facie case of obviousness exists when the claimed ranges overlap with ranges
`
`disclosed by the prior art. See MPEP § 2144.05 (I). One would have been motivated to
`
`select the width of the apertures within the claimed range for the purposeof facilitating
`
`delivery of negative pressure to the wound dressing. Further, Applicant places no
`
`criticality on the range claimed, indicating simply that the apertures may have a width
`
`between about 0.5 mm and 1.5 mm (40100 of instant specification).
`
`Regarding claim 18, Locke further discloses the second polymerfilm (210) has a
`
`thickness in a range of about 50 microns to about 100 microns (the secondfilm 210 has
`
`a thickness between 20 microns to 100 microns: 0064; thus, the taught thickness
`
`range overlaps the claimed thickness range).
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`by selecting the thickness of the secondfilm within the claimed range as it has been
`
`held that a prima facie case of obviousness exists when the claimed ranges overlap
`
`with ranges disclosed by the prior art. See MPEP § 2144.05 (I). One would have been
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 8
`
`motivated to select the thickness of the second film within the claimed range for the
`
`purpose of facilitating delivery of negative pressure to the wound dressing. Further,
`
`Applicant places nocriticality on the range claimed, indicating simply that a thickness of
`
`about 50 microns to about 100 microns may be suitable for some examples (§0060 of
`
`instant specification).
`
`Regarding claim 19, Locke further discloses the fluid restrictions are
`
`fenestrations in the second polymer film (the fluid restrictions 260 comprises
`
`perforations or linear slots in the second film 210: 40065-0066), wherein the
`
`fenestrations each have a length of about 2 millimeters to about 5 millimeters (the
`
`perforations or linear slots have a length less than 4 millimeters and at least 2
`
`millimeters: §O066; thus, the taught length range is within the claimed length range).
`
`See MPEP § 2131.03.
`
`In addition, one would have been motivated to select the length
`
`of the fenestrations within the claimed range for the purpose of facilitating delivery of
`
`negative pressure to the wound dressing. Further, Applicant places no criticality on the
`
`range claimed, indicating simply that the fluid restrictions 230 may comprise or consist
`
`of linear slots having a length less than 4 millimeters and the length may beat least 2
`
`millimeters (0067 of instant specification).
`
`Regarding claim 22, Locke further discloses the second polymer film (210) has a
`
`thickness between 20 microns to 100 microns (0064), but Locke/Collinson does not
`
`disclose the second polymerfilm (210) has a thickness in a range of about 200 microns
`
`to about 300 microns. However, a person having ordinary skill in the art would have
`
`understood that the thickness of the second polymerfilm varies according to needs of a
`
`prescribed therapy.
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 9
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`by selecting the thickness of the secondfilm within the claimed range as it has been
`
`held that a prima facie case of obviousness exists when the claimed ranges overlap
`
`with ranges disclosed bythe prior art. See MPEP § 2144.05(I). In addition, one would
`
`have been motivated to select the thickness of the secondfilm within the claimed range
`
`for the purposeof facilitating delivery of negative pressure to the wound dressing.
`
`Further, Applicant places no criticality on the range claimed, indicating simply that a
`
`thickness of about 200 microns to about 300 microns maybe suitable for some
`
`examples (0061 of instant specification).
`
`Regarding claim 31, Locke further discloses the first polymerfilm has a
`
`thickness of about 500 microns (the first polymerfilm 220 has a thickness in a range of
`
`about 20 to 500 micrometers: 40070; thus, the taught thickness range is within the
`
`claimed thickness range). See MPEP § 2131.03.
`
`In addition, one would have been
`
`motivated to select the thickness ofthe first polymer film within the claimed range for the
`
`purpose of facilitating delivery of negative pressure to the wound dressing. Further,
`
`Applicant places no criticality on the range claimed, indicating simply that the first layer
`
`may comprise a film having a thickness of about 500 microns (0093 of instant
`
`specification).
`
`Regarding claim 35, Locke further discloses each of the standoffs has a width in
`
`a range of about 1 millimeter to about 4 millimeters (each of the standoffs 270 has a
`
`diameter between approximately 1.0 mm and 3.0 mm: 0086; thus, the taught width
`
`range is within the claimed width range). See MPEP § 2131.03.
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 10
`
`Locke further discloses each of the standoffs has a height in a range of about 1
`
`millimeter to about 4 millimeters (each of the standoffs 270 has a height between
`
`approximately 0.5 mm and 3.0 mm: 40086; thus, the taught height range overlaps the
`
`claimed height range).
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`by selecting the height of each of the standoffs within the claimed range as it has been
`
`held that a prima facie case of obviousness exists when the claimed ranges overlap
`
`with ranges disclosed by the prior art. See MPEP § 2144.05(I). In addition, one would
`
`have been motivated to select the height of each of the standoffs within the claimed
`
`range forthe purpose offacilitating delivery of negative pressure to the wound dressing.
`
`Further, Applicant places no criticality on the range claimed, indicating simply that each
`
`of the standoffs may have a height between approximately 1 millimeter and 4
`
`millimeters (§O0093 of instant specification).
`
`Locke further discloses each of the standoffs 270 has a spacing/pitch of
`
`approximately 2.0 mm (40086), but does not disclose each of the standoffs have a pitch
`
`of about 3.5 millimeters to about 4 millimeters. However, a person having ordinary skill
`
`in the art would have understood that the a spacing/pitch of each of the standoffs varies
`
`according to needs of a prescribed therapy.
`
`It would have been obvious to oneof ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`by selecting the spacing/pitch of each of the standoffs within the claimed range asit has
`
`been held that a prima facie case of obviousness exists when the claimed ranges
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 11
`
`overlap with ranges disclosed by the prior art. See MPEP § 2144.05 (I).
`
`In addition, one
`
`would have been motivated to select the spacing/pitch of each of the standoffs within
`
`the claimed range for the purpose offacilitating delivery of negative pressure to the
`
`wound dressing. Further, Applicant places no criticality on the range claimed, indicating
`
`simply that the standoffs may bedistributed acrossthe first layer in a uniform grid or
`
`array having a pitch of approximately 3.5 millimeters to about 4 millimeters (0093 of
`
`instant specification).
`
`Regarding claim 45, Locke further discloses the coveris disposed over the first
`
`polymerfilm (¢0076 and Fig. 10).
`
`Regarding claim 46, Locke further discloses a spacer (a fourth layer 225: 40052
`
`and Fig. 2) disposed between thefirst aperture 294 in the cover 106 (Fig. 2) and the first
`
`polymerfilm 220 (0080 and Fig. 2). Locke does not disclose the spacer 225 disposed
`
`between the first aperture in the cover and the second aperture in the first polymer film
`
`and the spacer axially aligned with the first aperture and the second aperture; however,
`
`Locke in view of Collinson discloses the first aperture and the second aperture are
`
`aligned with each other (see rejection of claim 1 above). Thus, a person having ordinary
`
`skill in the art would understand that the spacer inherently disposed between thefirst
`
`aperture in the cover and the second aperture in the first polymerfilm and axially
`
`aligned with the first aperture and the second aperture becausefirst aperture and the
`
`second aperture are axially aligned with each other.
`
`Regarding claim 53, Locke further discloses a layerof gel (a first layer 205
`
`comprises a gel: (0053 and Fig. 2) disposed adjacent to the second polymer film
`
`opposite the first polymer film (0052 and Fig. 2), the layer of gel having perforations
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 12
`
`(apertures 240: (0055 and Fig. 2) fluidly coupled with at least some ofthe fluid
`
`restrictions (apertures 240 is fluidly coupled with at least some of the fluid restrictions
`
`260: 40083 and Fig. 5).
`
`Regarding claim 55, Locke further discloses the standoffs comprise blisters,
`
`bubbles, cells, bosses, or a combination thereof (40068-0069).
`
`Regarding claim 61, Locke disclosesall the limitations as discussed above for
`
`claim 56.
`
`Locke further discloses the cover, the first polymerfilm, the second polymer film,
`
`and the third layer are transparent (§0106).
`
`Regarding claim 66, Locke discloses a dressing (a dressing 102: 40030 andFig.
`
`2) for treating a tissue site with negative pressure (Abstract and 40030), the dressing
`
`(102) comprising:
`
`a cover(a cover 106: 40042 and Fig. 2) having an aperture (an aperture 294:
`
`40080 and Fig. 2);
`
`a first layer (a third layer 220: 40052 and Fig. 2) comprising a plurality of
`
`standoffs (blister 270: (0068, Figs. 2, and 6-7) and at least one fluid passage (apertures
`
`275 are configured to allow fluid transfer through the film 220: 40068 and Fig. 2);
`
`a second layer (a second layer 210: 40052 and Fig. 2) comprising a plurality of
`
`slots (fluid restrictions comprise slots 260: 0066 and Fig. 2); and
`
`a third layer (a first layer 205: ¥0052 and Fig.2) comprising a plurality of
`
`apertures (aperture 240: 90055 and Fig. 2);
`
`wherein the cover, the first layer, the second layer, and the third layer are
`
`assembled in a stackedrelationship with the first layer and the second layer disposed
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 13
`
`between the coverandthe third layer (Figs. 2 and 8), at least some of the slots are
`
`exposed through the plurality of apertures in the third layer (§0083 and Fig. 5), the
`
`aperture in the coveris fluidly coupled to at least one fluid passage in thefirst layer
`
`((0080 and Fig. 2), and the standoffs are disposed adjacent to the second layer ({0068
`
`and Fig. 7);
`
`wherein the aperture in the cover comprisesa first aperture (Fig. 2), the at least
`
`one fluid passage in the first layer (aperture 275: Fig. 2) comprises a Second aperture
`
`(one of the fluid passages 275) and a plurality of fluid passages (some ofthe fluid
`
`passages 275) adjacent to the standoffs (0068 and Fig. 2).
`
`Locke does not disclose the second aperture axially aligned with the first
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`aperture in the cover.
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`Collinson further teaches the cover 3910 comprising an opening 3911 and each of
`
`the layers 3920/3930/3940
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`comprising openings 3921/3931/3941
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`and wherein all
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`openings are aligned to each other and underlying a port 3990 at/near a center of the
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`dressing ((0141 and Fig. 4D) for the benefit of allowing the negative pressure applied to
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`the port to be communicated directly to the transmission layer without passing through
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`other layers (¢0117 and 0141). From these teachings, a person having ordinary skill
`
`in
`
`the art would have recognized/deduced that arranging the second aperture on thefirst
`
`layer so that
`
`the second aperture is axially aligned with the first aperture yields the
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`predictable
`
`result
`
`of allowing
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`the negative pressure
`
`applied to the port
`
`to be
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`communicateddirectly to the second layer and the third layer without passing through the
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`first layer.
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 14
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`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to have modified the first layer of Locke in view
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`Collinson by axially aligning the second aperture with the first aperture in the cover, in
`
`order to allow the negative pressure applied to a port to be communicateddirectly to the
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`second and third layers without passing through the first layer, as suggested in 40117
`
`and 0141 of Collinson and as it has been held that a mere rearrangement of element
`
`without modification of the operation of the device involvesonly routine skill in the art
`
`(See MPEP § 2144.04 (VI) (C)). In addition, a person having ordinary skill in the art
`
`would have motivated to rearrange the second aperture on the first layer to be axially
`
`aligned with the first aperture of the coverto facilitate delivery of negative pressure to
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`the wound dressing.
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`In addition, since the second aperture is aligning with the port 3990
`
`at/near the center of the dressing (see rejection above), the second aperture is
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`positioned at/near the center of the dressing or the first layer. Thus, the plurality of fluid
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`passages adjacent to the standoffs of Locke in view Collinson are around the second
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`aperture.
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`Regarding claim 67, Locke discloses an apparatus (a therapy system 100:
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`40028 and Fig. 1) for treating a tissue site with negative pressure (§0028), the
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`apparatus (100) comprising:
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`a dressing (0030 and Fig. 2) according to claim 1; and
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`a negative pressure source (104) fluidly coupled to the dressing (40030).
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`Regarding claim 69, Locke discloses the dressing of claim 1 (see rejection of
`
`claim 1 above).
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`
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`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 15
`
`Lockefurther discloses a negative pressure source (104) fluidly coupled to the
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`dressing (0030).
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`Since the dressing of Locke meets the structural limitations of the claimed
`
`dressing,
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`it will inherently perform the method steps as claimed (See MPEP § 2112.02
`
`(l)). Thus, Locke further discloses a methodof treating a tissue site with negative
`
`pressure, the method comprising: applying the dressing of claim 1; applying negative
`
`pressure to the tissue site through the dressing; and observing the tissue site through
`
`the dressing.
`
`Claim(s) 51 and 70 is/are rejected under 35 U.S.C 103 as being unpatentable
`
`over Locke (US PGPUB 20180353662 — of record) in view of Collinson (US PGPUB
`
`20160144084), as applied to claim 1 above, and further in view of Dreier (US PAT
`
`6213992).
`
`Regarding claim 51, Locke/Collinson does not disclose a screen removably
`
`attached to the cover with a re-sealable adhesive and wherein the screen is opaque.
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`In an analogous art, absorbent articles, Dreier discloses a disposable garment,
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`such as a diaper, having a liner, an absorbent core andaliquid impervious bottom sheet
`
`(Abstract and Fig. 1). Dreier further teaches the disposable garment comprising an
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`opaque screen 46 removably attached to an exterior surface of a bottom sheetwith a re-
`
`sealable adhesive 48 (Col. 5, line 66 — Col. 6,line 8 and Fig. 4) for the benefits of viewing
`
`the interior of the garment and detaching and reattaching the screen multiple times as
`
`needed (Col. 5, line 66 — Col. 6, line 8). From these teachings, a person having ordinary
`
`skill
`
`in the art would have recognized/deduced that
`
`incorporating an opaque screen
`
`removably attached to the cover with a re-sealable adhesive yields the predictable result
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 16
`
`of enabling clinicians for viewing wound exudate when they need and detaching and
`
`reattaching the screen multiple times as needed.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`in view of Dreier by incorporating an opaque screen removably attached to the cover
`
`with a re-sealable adhesive, in order to enable clinicians for viewing wound exudate
`
`when they need and detaching and reattaching the screen multiple times as needed, as
`
`suggested in Col. 5, line 66 — Col. 6, line 8 of Dreier.
`
`Regarding claim 70, Locke and Collinson disclose the dressing of claim 1 (see
`
`rejection of claim 1 above).
`
`Locke further discloses a negative pressure source (104) fluidly coupled to the
`
`dressing (0030).
`
`Locke does not disclose a screen configured to obscure the tissue site.
`
`Dreier further teaches the disposable garment comprising an opaque screen 46
`
`removably attached to an exterior surface of a bottom sheet with a re-sealable adhesive
`
`48 (Col. 5, line 66 — Col. 6, line 8 and Fig. 4) for the benefits of viewing the interior of the
`
`garment(Col. 5, line 66 — Col. 6, line 8). From these teachings, a person having ordinary
`
`skill in the art would have recognized/deduced that incorporating an opaque screen yields
`
`the predictable result of enabling clinicians for viewing wound exudate when they need.
`
`It would have been obvious to one of ordinary skill in the art before the effective
`
`filling date of the claimed invention to further modify the dressing of Locke and Collinson
`
`in view of Dreier by incorporating an opaque screen, in order to enable clinicians for
`
`
`
`Application/Control Number: 17/442,815
`Art Unit: 3781
`
`Page 17
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`viewing wound exudate when they need, as suggested in Col. 5, line 66 — Col. 6,line 8
`
`of Dreier.
`
`Since the dressing of Locke and Collinson in view of Dreier meets the structural
`
`limitations of the claimed dressing, it will inherently perform the method steps as
`
`claimed (See MPEP § 2112.02 (I)). Thus, Locke and Collinson in view of Dreier further
`
`discloses a method oftreating a tissue site with negative pressure, the method
`
`comprising: applying the dressing of claim 1; applying negative pressure to the tissue
`
`site through the dressing; removing the screen; observing the tissue site through the
`
`dressing; and replacing the screen to obscure the tissuesite.
`
`Claim(s) 56, 58, 61, and 65 is/are rejected under 35 U.S.C 103 as being
`
`unpatentable over Locke (US PGPUB 20180353662) in view of Collinson (US
`
`PGPUB 20160144084), as applied to claim 1 above, and further in view of Locke
`
`(US PGPUB 20180353342).
`
`Regarding claim 56, Locke further disclosesathird layer(a first layer 205: (0055
`
`and Fig. 2); wherein the cover, the first polymer film, the second polymer film, and the
`
`third layer are assembled in a stacked relationship with the first polymer film and the
`
`second polymer film disposed between the