www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/294,624
`
`05/17/2021
`
`Benjamin A. PRATT
`
`P001756US02PCT
`
`1021
`
`60402
`
`7590
`
`12/21/2023
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`MCQUIGGAN,ERIC RICHARD
`
`Para NONE
`
`3786
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/21/2023
`
`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):
`
`dgodzisz@hdp.com
`troymailroom @hdp.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-22 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`C} Claim(s)__ is/are allowed.
`Claim(s) 1-22 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://www.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){¥] The drawing(s) filed on 17 May 2021 is/are: a) accepted or b)(J 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)(¥) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Y) All
`1.) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.2.) 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)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date Attached
`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 20231130
`
`Application No.
`Applicant(s)
`17/294,624
`PRATTet al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`ERIC MCQUIGGAN
`3786
`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 17 May 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: 17/294,624
`Art Unit: 3786
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA orAIA Status
`
`The presentapplication,filed on or after March 16, 2013, is being examined under the first
`
`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.
`
`Claims 1-10, 12-13, and 17-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA),
`
`second paragraph,as being indefinite for failing to particularly point out and distinctly claim the subject
`
`matter which the inventoror a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the
`
`applicant), regards as the invention.
`
`The term “substantially” in claims 1, 3,5, 12, and 17 is a relative term which renders the claim
`
`indefinite. The term “substantially” is not defined by the claim, the specification does not provide a
`
`standard for ascertaining the requisite degree, and one of ordinaryskill in the art would not be
`
`reasonably apprised of the scope of the invention. The term “substantially” renders the limitation
`
`“orevents” indefinite, as it is unclear as to the degree as to which the collapse is prevented, for example,
`
`if collapse is entirely prevented or if there isan amountof collapse that occurs toa finite degree or
`
`range. For examination purposes, “substantially prevents” has been interpreted as —prevent--.
`
`The term “substantially” in claim 16 is a relative term which renders the claim indefinite. The
`
`term “substantially” is not defined by the claim, the specification does not provide a standard for
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 3
`
`ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised
`
`of the scope of the invention. The term “substantially” renders the limitation “same”indefinite, as it is
`
`unclear as to the degree as to which the pressure is equalized, for example, if the pressure is exactly the
`
`same or if there is asmall degree or range in which the pressureis different . For examination purposes,
`
`“substantially the same pressure” has been interpreted as --the same pressure--.
`
`The term “approximately” in claims 2, 4, 13, and 18-19 is a relative term which renders the claim
`
`indefinite. The term “approximately” is not defined by the claim, the specification does not provide a
`
`standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be
`
`reasonably apprised of the scope of the invention. The term “approximately” renders the succeeding
`
`ratio indefinite, as it is unclear to whether the ratio is to be exact, or if there is a degree or range of
`
`variation acceptable among the values. For examination purposes, “approximately 1:10:25”,
`
`“approximately 1:1600”, “approximately 1:800”, have been interpreted as --1:10:25--, --1:1600--, and --
`
`1:800--.
`
`The term “approximately” in claims 20 is a relative term which renders the claim indefinite. The
`
`term “approximately” is not defined by the claim, the specification does not provide a standard for
`
`ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised
`
`of the scope of the invention. The term “approximately” renders “6 millimeters” indefinite, as it is
`
`unclear to whether the measurementis to be exact,or if there is a degree or range of variation
`
`acceptable among the measurement. For examination purposes, “approximately 6 millimeters” has
`
`been interpreted as --6 millimeters--.
`
`Claims 6-10 and 21-22 are rejected for being dependent on the rejected claims 1 and 17
`
`respectively.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 4
`
`Claim Rejections - 35 USC § 103
`
`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 forthin 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
`effective 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.
`
`Claim(s) 1-3, 7-10, 17-18, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable
`
`over Luckemeyer(US 20150119830 A1) in view of Petrosenko (US 20060041247A1).
`
`Regarding claim 1, Luckemeyer discloses an analogous wound treatment system for treating a
`
`surgical wound (a system for treating a tissue site ofa patient, paragraphs [0003], [0023]), comprising:
`
`a dressing (dressing 124, paragraph [0025]), comprising: a manifold layer (interface manifold 120,
`
`paragraph [0025]); an absorbent pouch (wicking layer enclosure 172, paragraph [0048]) assembly
`
`coupled to the manifold layer (the fluid management system 144, comprising the wicking layer
`
`enclosure 172,is coupled to the base layer 132, wherein the base layer 132 is bound to the interface
`
`manifold 120, paragraphs [0030], [0070], therefore, the wicking layer enclosure 172 is coupled to the
`
`interface manifold 120), the absorbent pouch assembly (172) comprising an absorbent material
`
`contained within a pouch (absorbent layer 184is disposed within the enclosure 172, paragraph
`
`[0047]); a drape (sealing member 140, paragraph [0028]) coupled to the absorbent pouch assembly
`
`(172) (see FIG. 1, and paragraphs [0028], [0044]; the sealing member 140is in continuous contact with
`
`enclosure 172, and is maintainedin this configuration via adhesive 136) and configured to be sealable
`
`over the surgical wound (the periphery 164 of the sealing member 140is configured to provide a fluid
`
`seal about the tissue site 104, paragraph [0044]), the absorbent pouch (172) assembly positioned
`
`between the drape (140) and the manifold layer (120) (see FIG. 1; the enclosure 172 is positioned
`
`betweenthe interface manifold 120 and sealing member 140); a pump (reduced-pressure source 128,
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page5S
`
`wherein the reduced-pressure source 128 may be a pump, paragraph [0062]) fluidly communicable
`
`with the dressing (124) (the reduced-pressure source 128is in fluid communication with dressing 124,
`
`paragraph [0066]) and configured to drawa negative pressure at the manifold layer (120) (the reduced-
`
`pressure source 128 provides reduced pressure to the interface manifold 120, paragraph [0028],
`
`wherein reduced-pressure is correlates to a negative pressure in regards to ambient pressure,
`
`paragraph [0064]).
`
`Luckemeyer does not disclose wherein the manifold layer is configured to prevent medial
`
`collapse of the manifold layer under the negative pressure.
`
`However, Petrosenko teaches an analogous manifold layer for use in negative pressure
`
`treatment of wounds (wound insert 26, paragraph [0034], wherein the insert 26 may be usedin
`
`conjunction with negative pressure therapy, paragraph [0036]) wherein the manifold layer (26)is
`
`configured to prevent medial collapse of the manifold layer under the negative pressure (the wound
`
`insert 26 is non-compressible, and the thickness of the insert 26 is maintained when negative pressure
`
`is applied, paragraph [0036]).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer to be configured
`
`to prevent medial collapse of the manifold layer under the negative pressure, as taught by Petrosenko,
`
`in order to provide an improved insert capable of maintaining a constant thickness under negative
`
`pressure by providing a non-compressible insert to prevent wound closure (Petrosenko, paragraphs
`
`[0007], [0036]).
`
`Regarding claim 2, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer does not disclose wherein the manifold layer has a thickness-to-width-to-length
`
`ratio of 1:10:25.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 6
`
`However, Petrosenko further teaches wherein the manifold layer (26) has a thickness-to-width-
`
`to-length ratio of 1:10:25 (the thickness 43 of the insert 26 may be 1mm,the width 42 of the insert 26
`
`may be up to 30mm, thus selectable to be 10mm, and the length 40 of the insert 26 may be up to
`
`30mm,thus selectable to be 25mm, paragraph [0038]. Therefore, a person of ordinaryskillin the art
`
`may select the insert 26 to have a thickness-to-width-to-length ratio of 1:10:25) (In the case where the
`
`claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of
`
`obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d
`
`1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer to have a
`
`thickness to-width-to-length ratio of 1:10:25, as taught by Petrosenko, in order to provide an improved
`
`insert capable of maintaining a constant thickness under negative pressure by providing a non-
`
`compressible insert to prevent wound closure (Petrosenko, paragraphs [0007], [0036]).
`
`Regarding claim 3, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer does not disclose wherein the thickness-to-width-to-length ratio prevents the
`
`medial collapse of the manifold layer under the negative pressure.
`
`However, Petrosenko further teaches wherein the thickness-to-width-to-length ratio (the
`
`thickness 43 of the insert 26 may be 1mm, the width 42 of the insert 26 may be up to 30mm, thus
`
`selectable to be 10mm,and the length 40 of the insert 26 may be up to 30mm,thus selectable to be
`
`25mm,paragraph [0038]. Therefore, a person of ordinary skillin the art may select the insert 26 to
`
`havea thickness-to-width-to-length ratio of 1:10:25) (In the case where the claimed ranges “overlap
`
`orlie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim,
`
`541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934(Fed. Cir.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 7
`
`1990)) prevents the medial collapse of the manifold layer (26) under the negative pressure (paragraph
`
`[0036]) (the thickness, width, and length contribute to the overall structure of the insert 26 such that
`
`the characteristics of the insert 26, including its dimensions, contribute at least somewhat to the
`
`functionality of not collapsing, wherein it is knownin the art that modifying a dimension, such as
`
`decreasing the thickness, would impart a reducedrigidity. Wherein, the wound insert 26 is non-
`
`compressible, and the thickness of the insert 26 is maintained when negative pressureis applied,
`
`paragraph [0036]).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer such that the
`
`thickness-to-width-to-length ratio prevents the medial collapse of the manifold layer under the negative
`
`pressure, as taught by Petrosenko,in order to provide an improved insert capable of maintaining a
`
`constant thickness under negative pressure by providing a non-compressible insert to prevent wound
`
`closure (Petrosenko, paragraphs [0007], [0036]).
`
`Regarding claim 7, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses a reduced-pressure interface (conduit interface 148, paragraph
`
`[0028]) integrated with the drape (140) (see FIG. 1, and paragraph [0054]; the conduit interface 148is
`
`positioned within aperture 170 of sealing member 140) and aligned with a hole (aperture 170,
`
`paragraph [0054]) extending through the drape (140) (aperture 170 extends through sealing member
`
`140); a tube (conduit 196, paragraph [0065], FIG. 1) coupled between the reduced-pressureinterface
`
`(148) and the pump (128) (see FIG. 1; conduit 196 is positioning between the conduit interface 148 and
`
`the reduced-pressure source 128); wherein the pump (128)is fluidly communicable with the absorbent
`
`pouch assembly (172) and the manifold layer (120) via the tube (196), the reduced-pressure interface
`
`(148), and the hole (170) (the reduced-pressure source 128is in fluid communication with the dressing
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 8
`
`124, including the wicking layer enclosure 172, interface manifold 120 via the conduit 196, conduit
`
`interface 148, and aperture 170, paragraphs [0028], [0029], [0037], [0047], [0049], [0065]).
`
`Regarding claim 8, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses wherein the manifold layer (120) comprisessilver ions (the
`
`interface manifold 1220 may haveionic silver added thereto, paragraph [0026)]).
`
`Regarding claim 9, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses wherein the manifold layer (120) is configured to wick fluid from
`
`the surgical wound (the interface manifold 120 is capable ofcollecting fluids, paragraph [0025]); and
`
`wherein the absorbent pouch assembly (172) is configured to absorb the fluid from the manifold layer
`
`(120) (the fluid management assembly 144, comprising enclosure 172, wicks the fluid from the intake
`
`manifold 120, paragraph [0071)).
`
`Regarding claim 10, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses wherein the absorbent material (184) comprises a superabsorbent
`
`material {the absorbent layer may bea sodium polyacrylate super absorber, paragraph [0051]).
`
`Regarding claim 17, Luckemeyer discloses an analogous method for manufacturing a dressing
`
`deployable to treat a surgical wound using negative pressure therapy without exerting a closure force
`
`on the surgical wound (creating a system for treating the tissue site by removing fluids therefrom by
`
`applying a negative pressure, paragraphs [0003], [0022]-[0025], [0064], wherein the system is not
`
`disclosed as being capable of closing the wound), the method comprising: enclosing an absorbent
`
`material (absorbent layer 184, paragraph [0047]) ina pouch (wicking layer enclosure 172, paragraph
`
`[0048]) (absorbent layer 184 is disposed within wicking layer enclosure 172, paragraph [0047));
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 9
`
`coupling a manifold layer (interface manifold 120, paragraph [0025]) to the pouch (172) (the fluid
`
`management system 144, comprising the wicking layer enclosure 172, is coupled to the base layer
`
`132, wherein the base layer 132 is bound to the interface manifold 120, paragraphs [0030], [0070],
`
`therefore, the wicking layer enclosure 172 is coupled to the interface manifold 120); coupling a drape
`
`a drape (sealing member 140, paragraph [0028]) tothe pouch (172) (see FIG. 1, and paragraphs [0028],
`
`[0044]; the sealing member 140placedis in continuous contact with enclosure 172, and is maintained
`
`in this configuration via adhesive 136) such that the pouch (172) and the absorbent material (184) are
`
`between the manifold layer and the drape (see FIG. 1; the enclosure 172 is positioned between the
`
`interface manifold 120 and sealing member 140); coupling a reduced-pressure interface (conduit
`
`interface 148, paragraph [0028]) tothe drape (140) (see FIG. 1, and paragraph [0054]; the conduit
`
`interface 148 is positioned within aperture 170 of sealing member 140), the reduced-pressure
`
`interface (148) coupleable to a pump (reduced-pressure source 128, wherein the reduced-pressure
`
`source 128 may bea pump,paragraph [0062]) configured to provide the negative pressure at the
`
`manifold layer (120) (the reduced-pressure source 128 provides reduced pressure to the interface
`
`manifold 120, paragraph [0028], wherein reduced-pressureis correlates to a negative pressure in
`
`regards to ambient pressure, paragraph [0064)]).
`
`Luckemeyer does not disclose wherein the manifold layer configured to prevent medial collapse
`
`of the manifold layer when subjected to a negative pressure.
`
`However, Petrosenko teaches an analogous manifold layer for use in negative pressure
`
`treatment of wounds (wound insert 26, paragraph [0034], wherein the insert 26 may be usedin
`
`conjunction with negative pressure therapy, paragraph [0036]) wherein the manifold layer (26)is
`
`configured to prevent medial collapse of the manifold layer under the negative pressure (the wound
`
`insert 26 is non-compressible, and the thickness of the insert 26 is maintained when negative pressure
`
`is applied, paragraph [0036]).
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 10
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer to be configured
`
`to prevent medial collapse of the manifold layer under the negative pressure, as taught by Petrosenko,
`
`in order to provide an improved insert capable of maintaining a constant thickness under negative
`
`pressure by providing a non-compressible insert to prevent wound closure (Petrosenko, paragraphs
`
`[0007], [0036]).
`
`Regarding claim 18, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer does not disclose forming the manifold layer witha thickness-to-width-to-length
`
`ratio of 1:10:25.
`
`However, Petrosenko further teaches forming the manifold layer (26) with a thickness-to-width-
`
`to-length ratio of 1:10:25 (the thickness 43 of the insert 26 may be 1mm,the width 42 of the insert 26
`
`may be up to 30mm, thus selectable to be 10mm, and the length 40 of the insert 26 may be up to
`
`30mm,thus selectable to be 25mm, paragraph [0038]. Therefore, a person of ordinary skillin the art
`
`may select the insert 26 to have a thickness-to-width-to-length ratio of 1:10:25) (In the case where the
`
`claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of
`
`obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d
`
`1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer to be formed
`
`with a thickness to-width-to-length ratio of 1:10:25, as taught by Petrosenko, in order to provide an
`
`improved insert capable of maintaining a constant thickness under negative pressure by providing a
`
`non-compressible insert to prevent wound closure (Petrosenko, paragraphs [0007], [0036]).
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 11
`
`Regarding claim 20, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer does not disclose comprising forming the manifold layer with a thickness of 6
`
`millimeters.
`
`However, Petrosenko further teaches forming the manifold layer (26) with a thickness of 6
`
`millimeters (the insert 26 may havea thickness from 1-15mm,therefore, one of ordinaryskillin the
`
`art mayselect the thickness to be 6mm, paragraph [0038]) (In the case where the claimed ranges
`
`“overlap orlie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In
`
`reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934
`
`(Fed. Cir. 1990)).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer to be formed
`
`with a thickness of 6 millimeters, as taught by Petrosenko, in order to provide an improved insert
`
`capable of maintaining a constant thickness under negative pressure by providing a non-compressible
`
`insert to prevent wound closure, and further,to fit a specific wound size for a particular wound
`
`(Petrosenko, paragraphs [0007], [0036]).
`
`Regarding claim 21, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses providing the manifold layer (120) with silver ions (the interface
`
`manifold 1220 may haveionic silver added thereto, paragraph [0026)).
`
`Regarding claim 22, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses wherein the absorbent material (184) is a superabsorbent material
`
`(the absorbent layer may bea sodium polyacrylate super absorber, paragraph [0051]).
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 12
`
`Claim(s) 4, 5, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Luckemeyer(US 20150119830 A1)in view of Petrosenko (US 20060041247A1) further in view of
`
`Ugander (US 20070260207 A1).
`
`Regarding claim 4, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer in view of Petrosenko does not disclose wherein the manifold layer has a thickness-
`
`to-area ratio of 1:1600.
`
`However, Ugander teaches an analogous manifold layer for use in negative pressure treatment
`
`of wounds(barrier disc 1, paragraph [0029], wherein the barrier disc 1 placed inside the wound for use
`
`in conjunction with negative pressure, paragraphs [0031], [0033]) wherein the manifold layer (1) has a
`
`thickness-to-area ratio of 1:1600 (area is defined as the length multiplied by the width of an object.
`
`When the thickness is converted to centimetersto reflect the units of the length and width, the
`
`thickness maybe selected to be .1cm. Furthermore, the length may be selected to be 16cm and the
`
`width may be selected to be 10cm, thus defining a160cm area. The ratio therefore being defined as
`
`.1:160, thus equivalent to 1:1600).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer in view of
`
`Petrosenko such that the manifold layer has a thickness-to-area ratio of 1:1600, as taught by Ugander,
`
`in order to provide an improved wound contact structure capable of resisting deformation and bending
`
`when pressureis applied by modifying the rigidity of the structure to avoid damage to the surrounding
`
`tissue structures (Ugander, paragraphs [0010]-[0012], [0029] -[0030]).
`
`Regarding claim5, Luckemeyer in view of Petrosenko further in view of Ugander discloses the
`
`invention as discussed above.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 13
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`Luckemeyer in view of Petrosenko does not disclose wherein the thickness -to-area ratio
`
`prevents the medial collapse of the manifolding layer under the negative pressure.
`
`However, Ugander further teaches wherein the thickness-to-area ratio prevents the medial
`
`collapse of the manifolding layer under the negative pressure (the thickness, width, and length
`
`contribute to the overall structure of the barrier disc such that the characteristics of the barrier disc 1,
`
`including its dimensions, contribute at least somewhat to the functionality of preventing deformation,
`
`whereinit is knownin the art that decreasing a dimension, suchas thickness, would impart a reduced
`
`rigidity. Wherein, the barrier disc 1 is not bent, deformed, or sucked up whena negative pressureis
`
`applied, paragraph [0030]).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer in view of
`
`Petrosenko such that the wherein the thickness-to-area ratio prevents the medial collapse of the
`
`manifolding layer under the negative pressure, as taught by Ugander, in order to provide an improved
`
`wound contact structure capable of resisting deformation and bending when pressureis applied by
`
`modifying the rigidity of the structure to avoid damage to the surrounding tissue structures (Ugander,
`
`paragraphs [0010] -[0012], [0029]-[0030]).
`
`Regarding claim 19, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer in view of Petrosenko does not disclose forming the manifold layer with a
`
`thickness-to- area ratio of 1:1600.
`
`However, Ugander teaches an analogous manifold layer for use in negative pressure treatment
`
`of wounds(barrier disc 1, paragraph [0029], wherein the barrier disc 1 placed inside the wound for use
`
`in conjunction with negative pressure, paragraphs [0031], [0033]) by forming the manifold layer (1)
`
`with a thickness-to-area ratio of 1:1600 (area is defined as the length multiplied by the width of an
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 14
`
`object. When the thicknessis converted to centimeters to reflect the units of the length and width,
`
`the thickness may be selected to be .1cm. Furthermore, the length may be selected to be 16cm and
`
`the width may be selected to be 10cm, thus defining a 160cm area. The ratio therefore being defined
`
`as .1:160, thus equivalent to 1:1600).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have modified the manifold layer of Luckemeyer in view of
`
`Petrosenko to be formed with a thickness-to-area ratio of 1:1600, as taught by Ugander, in order to
`
`provide an improved wound contact structure capable of resisting deformation and bending when
`
`pressure is applied by modifying the rigidity of the structure to avoid damage tothe surrounding tissue
`
`structures (Ugander, paragraphs [0010] -[0012], [0029]-[0030)).
`
`Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luckemeyer (US
`
`20150119830 A1)in view of Petrosenko (US 20060041247 A1) further in view ofJoshi(US
`
`20070265585 A1).
`
`Regarding claim 6, Luckemeyer in view of Petrosenko discloses the invention as discussed
`
`above.
`
`Luckemeyer further discloses wherein the dressing (124) comprising a release liner (release liner
`
`162, paragraph [0043]) removable from the dressing (the base layer 132 may havearelease liner
`
`attached to and removable therefrom).
`
`Luckemeyer in view of Petrosenko does not disclose the release liner protecting the manifold
`
`layer before the dressing is applied to the surgical wound.
`
`However, Joshiteaches an analogous wound treatment system (a system for treating surgical
`
`and other types of wounds with negative pressure therapy, paragraph [0001]) wherein the release
`
`liner (protective seal 16, paragraph [0029]) protecting the manifold layer (wound interface 41,
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 15
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`paragraph [0032], wherein the wound interface 41 is placed in direct contact with the wound and is
`
`covered by the protective cover 16, paragraphs [0029]-[0031], FIG. 2) before the dressing is applied to
`
`the surgical wound (the protective seal 16 is removed prior to placement onauser, paragraph [0029]).
`
`Therefore, it would have been obvious to one of ordinary skill in the art before the effective
`
`filing date of the claimed invention to have provided the manifold layer of Luckemeyer in view of
`
`Petrosenko with a release liner protecting the manifold layer before the dressingis applied to the
`
`surgical wound , as taught by Joshi, in order to provide an improved tissue-fixation element capable of
`
`maintaining its adhesion, and remaining clean and sterile prior to application, by providing a protective
`
`cover below the wound interface to improve the connection of the dressing, as well as to prevent the
`
`wound site from being exposed to external contaminants