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
`
`07/18/2024
`
`KINETIC CONCEPTS, INC.
`c/o Harness Dickey & Pierce
`5445 Corporate Drive
`Suite 20
`Troy, MI 48098
`
`EXAMINER
`
`FISHER, VICTORIA HICKS
`
`Para NONE
`
`3786
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/18/2024
`
`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*
`1-12 and 14-22 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`5a) Of the above claim(s) _ is/are withdrawn from consideration.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) 1-12 and 14-22 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)0) The drawing(s) filedon__ is/are: a)(J 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)7) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1.1.) Certified copies of the priority documents have been received.
`2.2) 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)
`
`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)
`
`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 20240713
`
`Application No.
`Applicant(s)
`17/294,624
`PRATTet al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`VICTORIA H FISHER
`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 6/27/2024.
`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: 17/294,624
`Art Unit: 3786
`
`Page 2
`
`DETAILED ACTION
`
`This action is in response to the Requestfor Continued Examination (RCE)filed
`
`6/27/2024. Currently, claims 1-12 and 14-22 are pending in the application. Claims 13,
`
`23 and 24 are cancelled by Applicant.
`
`Notice of Pre-AlA or AIA Status
`
`The present application, filed on or after March 16, 2013, is being examined
`
`underthe first inventor to file provisions of the AIA.
`
`Continued Examination Under 37 CFR 1.114
`
`A requestfor continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), wasfiled 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 beentimely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`6/14/2024 has been entered.
`
`Response to Arguments
`
`Applicant’s amendmentto the specification is sufficient to overcome the previous
`
`objection to claims 2 and 18.
`
`Applicant's argumentsfiled 6/14/2024 have beenfully considered but they are
`
`not persuasive.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 3
`
`In responseto applicant's arguments against the referencesindividually, one
`
`cannot show nonobviousnessby attacking referencesindividually where the rejections
`
`are based on combinations of references. See /n re Keller, 642 F.2d 413, 208
`
`USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir.
`
`1986).
`
`In responseto applicant's argument that Luckemeyer and Petrosenko are
`
`nonanalogous art, it has been held that a prior art reference musteither be in the field of
`
`the inventor's endeavor or, if not, then be reasonably pertinent to the particular problem
`
`with which the inventor was concerned, in order to be relied upon as a basis for
`
`rejection of the claimed invention. See /n re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443
`
`(Fed. Cir. 1992).
`
`In this case, Luckemeyer and Petrosenkoarein the field of the
`
`inventor’s endeavor (negative pressure wound dressings).
`
`Applicant's remaining arguments fail to comply with 37 CFR 1.111(b) because
`
`they amountto a general allegation that the claims define a patentable invention without
`
`specifically pointing out how the language of the claims patentably distinguishes them
`
`from the references.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basisfor 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 setforth 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
`ordinaryskill in the art to which the claimed invention pertains.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 4
`
`Patentability shall not be negated by the manner in whichthe 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 20060041247 A1).
`
`Regarding claim 1, Luckemeyer discloses an analogous wound treatment
`
`system for treating a surgical wound (a system for treating a tissue site of a patient,
`
`paragraphs [0003], [0023]), comprising: a dressing (dressing 124, paragraph [0025)),
`
`comprising: a manifold layer (interface manifold 120 and base layer 132; paragraph
`
`[0025]) comprising foam ([0025] teaches “the tissue interface or the interface
`
`manifold 120 may be formed from any manifold material or flexible bolster
`
`material that provides a vacuum space, or treatment space, such as, for example,
`
`a porous and permeable foam or foam-like material, a member formed with
`
`pathways, a graft, or a gauze”): an absorbent pouch (wicking layer enclosure 172,
`
`paragraph [0048]) assembly positioned in direct contact with (Figure 1 teaches the
`
`base layer 132 being in direct contact with enclosure 172) the foam ([0025]
`
`teaches “the tissue interface or the interface manifold 120 may be formed from
`
`any manifold material or flexible bolster material that provides a vacuum space,
`
`or treatment space, such as, for example, a porous and permeable foam or foam-
`
`like material, a member formed with pathways,a graft, or a gauze”) of 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
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 5
`
`assembly (172) comprising an absorbent material contained within a pouch (absorbent
`
`layer 184 is 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 member140 is in continuous
`
`contact with enclosure 172, and is maintained in this configuration via adhesive
`
`136) and configured to be sealable over the surgical wound (the periphery 164 of the
`
`sealing member 140 is 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 (interface manifold 120 and base layer 132) (see FIG. 1;
`
`the enclosure 172 is positioned between the interface manifold 120 and sealing
`
`member 140); a pump (reduced-pressure source 128, wherein the reduced-
`
`pressure source 128 may be a pump,paragraph [0062]) fluidly communicable with
`
`the dressing (124) (the reduced-pressure source 128 is in fluid communication
`
`with dressing 124, paragraph [0066]) and configured to draw a negative pressureat
`
`the manifold layer (interface manifold 120 and base layer 132) (the reduced-
`
`pressure source 128 provides reduced pressureto 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 (woundinsert 26, paragraph [0034], wherein the
`
`insert 26 may be used in conjunction with negative pressure therapy, paragraph
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 6
`
`[0036]) wherein the manifold layer (26) is configured to prevent medial collapse of the
`
`manifold layer under the negative pressure (the woundinsert 26 is non-
`
`compressible, and the thicknessof the insert 26 is maintained when negative
`
`pressure is applied, paragraph [0036)).
`
`Therefore, it would have been obvious to oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerto be configured to prevent medial collapse of the manifold layer under the
`
`negative pressure, as taught by Petrosenko, in order to provide an improvedinsert
`
`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, Luckemeyerin view of Petrosenkodiscloses the invention
`
`as discussed above.
`
`Luckemeyer doesnot disclose wherein the manifold layer has a thickness-to-
`
`width-to-length ratio in a range of 1:(5-15):(15-25).
`
`However, Petrosenko further teaches wherein the manifold layer (26) has a
`
`thickness-to-width-to-length ratio in a range of 1:(5-15):(15-25) (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 5-15mm, and the length 40 of the insert 26 may be up to 30mm,
`
`thus selectable to be 15-25mm, paragraph [0038]. Therefore, a person of ordinary
`
`skill in the art may select the insert 26 to have a thickness-to-width-to-length ratio
`
`in a range of 1:(5-15):(15-25)) (In the case where the claimed ranges “overlapor lie
`
`inside ranges disclosed bythe prior art” a prima facie case of obviousness
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 7
`
`exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff,
`
`919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
`
`Therefore, it would have been obvious to oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerto havea thickness to-width-to-length in a range of 1:(5-15):(15-25), as
`
`taught by Petrosenko, in order to provide an improvedinsert 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, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyer doesnot 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 30mn, thus selectable to be 5-15mm, and the length 40 of the insert
`
`26 may be up to 30mm, thus selectable to be 15-25mm, paragraph [0038].
`
`Therefore, a person of ordinaryskill in the art may select the insert 26 to have a
`
`thickness-to-width-to-length ratio in a range of 1:(5-15):(15-25)) (In the case where
`
`the claimed ranges “overlap or lie inside ranges disclosed bythe prior art” a
`
`prima facie case of obviousnessexists. /n re Wertheim, 541 F.2d 257, 191 USPQ
`
`90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 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
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 8
`
`structure of the insert 26 such that the characteristics of the insert 26, including
`
`its dimensions, contribute at least somewhatto 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 thicknessof the insert 26 is maintained
`
`when negative pressure is applied, paragraph [0036)]).
`
`Therefore, it would have been obvious to oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyer suchthat 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, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyerfurther discloses a reduced-pressure interface (conduit interface
`
`148, paragraph [0028]) integrated with the drape (140) (see FIG. 1, and paragraph
`
`[0054]; the conduit interface 148 is 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-pressure
`
`interface (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
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 9
`
`(128) is fluidly communicable with the absorbent pouch assembly (172) and the
`
`manifold layer (interface manifold 120 and base layer 132) via the tube (196), the
`
`reduced-pressure interface (148), and the hole (170) (the reduced-pressure source
`
`128 is in fluid communication with the dressing 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, Luckemeyerin view of Petrosenko disclosesthe invention
`
`as discussed above.
`
`Luckemeyerfurther discloses wherein the manifold layer (interface manifold
`
`120 and base layer 132) comprisessilver ions (the interface manifold 1220 may
`
`haveionic silver added thereto, paragraph [0026)]).
`
`Regarding claim 9, Luckemeyerin view of Petrosenkodisclosesthe invention
`
`as discussed above.
`
`Luckemeyerfurther discloses wherein the manifold layer (interface manifold
`
`120 and baselayer 132) is configured to wick fluid from the surgical wound (the
`
`interface manifold 120 is capable of collecting fluids, paragraph [0025]); and
`
`wherein the absorbent pouch assembly (172) is configured to absorb the fluid from the
`
`manifold layer (interface manifold 120 and base layer 132) (the fluid management
`
`assembly 144, comprising enclosure 172, wicksthe fluid from the intake manifold
`
`120, paragraph [0071]).
`
`Regarding claim 10, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 10
`
`Luckemeyerfurther discloses wherein the absorbent material (184) comprises a
`
`superabsorbent material (the absorbent layer may be a sodium polyacrylate super
`
`absorber, paragraph [0051]).
`
`Regarding claim 17, Luckemeyerdiscloses an analogous methodfor
`
`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]) in a pouch
`
`(wicking layer enclosure 172, paragraph [0048]) (absorbent layer 184 is disposed
`
`within wicking layer enclosure 172, paragraph [0047]); coupling a manifold layer
`
`(interface manifold 120 and base layer 132; paragraph [0025]) comprising foam
`
`([0025] teaches “the tissue interface or the interface manifold 120 may be formed
`
`from any manifold material or flexible bolster material that provides a vacuum
`
`space, or treatment space, such as, for example, a porous and permeable foam or
`
`foam-like material, a member formed with pathways,a graft, or a gauze”’) 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
`
`boundtothe interface manifold 120, paragraphs [0030], [0070], therefore, the
`
`wicking layer enclosure 172 is coupled to the interface manifold 120) such that the
`
`foam ([0025] teaches “the tissue interface or the interface manifold 120 may be
`
`formed from any manifold material or flexible bolster material that provides a
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 11
`
`vacuum space, or treatment space, such as, for example, a porous and permeable
`
`foam or foam-like material, a member formed with pathways, a graft, or a gauze”)
`
`of the manifold layer (interface manifold 120 and base layer 132; paragraph [0025])
`
`is in direct contact with (Figure 1 teaches the baselayer 132 being in direct contact
`
`with enclosure 172) the pouch (172); coupling a drape a drape (sealing member 140,
`
`paragraph [0028}]) to the pouch (172) (see FIG. 1, and paragraphs [0028], [0044]; the
`
`sealing member 140 placedis 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 (interface manifold 120 and
`
`base layer 132) and the drape (see FIG. 1; the enclosure 172 is positioned between
`
`the interface manifold 120/ base layer 132 and sealing member 140); coupling a
`
`reduced-pressure interface (conduit interface 148, paragraph [0028]) to the drape
`
`(140) (see FIG. 1, and paragraph [0054]; the conduit interface 148 is positioned
`
`within aperture 170 of sealing member140), the reduced-pressure interface (148)
`
`coupleable to a pump (reduced-pressure source 128, wherein the reduced-pressure
`
`source 128 may be a pump,paragraph [0062]) configured to provide the negative
`
`pressure at the manifold layer (interface manifold 120 and baselayer 132) (the
`
`reduced-pressure source 128 provides reduced pressureto the interface manifold
`
`120, paragraph [0028], wherein reduced-pressure is correlates to a negative
`
`pressure in regards to ambient pressure, paragraph [0064)).
`
`Luckemeyer doesnot disclose wherein the manifold layer configured to prevent
`
`medial collapse of the manifold layer when subjected to a negative pressure.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 12
`
`However, Petrosenko teaches an analogous manifold layer for use in negative
`
`pressure treatment of wounds (woundinsert 26, paragraph [0034], wherein the
`
`insert 26 may be used in 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 woundinsert 26 is non-
`
`compressible, and the thicknessof the insert 26 is maintained when negative
`
`pressure is applied, paragraph [0036)).
`
`Therefore, it would have been obvious to oneofordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerto be configured to prevent medial collapse of the manifold layer under the
`
`negative pressure, as taught by Petrosenko, in order to provide an improvedinsert
`
`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, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyer doesnot disclose wherein the manifold layer has a thickness-to-
`
`width-to-length ratio in a range of 1:(5-15):(15-25).
`
`However, Petrosenko further teaches wherein the manifold layer (26) has a
`
`thickness-to-width-to-length ratio in a range of 1:(5-15):(15-25) (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 5-15mm, and the length 40 of the insert 26 may be up to 30mm,
`
`thus selectable to be 15-25mm, paragraph [0038]. Therefore, a person of ordinary
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 13
`
`skill in the art may select the insert 26 to have a thickness-to-width-to-length ratio
`
`in a range of 1:(5-15):(15-25)) (In the case where the claimed ranges “overlapor lie
`
`inside ranges disclosed bythe prior art” a prima facie case of obviousness
`
`exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff,
`
`919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
`
`Therefore, it would have been obvious to oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerto havea thickness to-width-to-length in a range of 1:(5-15):(15-25), as
`
`taught by Petrosenko, in order to provide an improvedinsert 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 20, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyer does not disclose comprising forming the manifold layer with a
`
`thicknessof 6 millimeters.
`
`However, Petrosenko further teaches forming the manifold layer (26) with a
`
`thickness of 6 millimeters (the insert 26 may have a thickness from 1-15mm,
`
`therefore, one of ordinaryskill in the art may select the thickness to be 6mm,
`
`paragraph [0038]) (In the case where the claimed ranges “overlap or lie inside
`
`ranges disclosed bythe prior art” a prima facie case of obviousnessexists. /n re
`
`Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
`
`16 USPQ2d 1934 (Fed. Cir. 1990)).
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 14
`
`Therefore, it would have been obvious to oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerto 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 woundsize for a particular wound (Petrosenko, paragraphs
`
`[0007], [0036]).
`
`Regarding claim 21, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyerfurther discloses providing the manifold layer (interface manifold
`
`120 and baselayer 132) with silver ions (the interface manifold 1220 may haveionic
`
`silver added thereto, paragraph [0026)]).
`
`Regarding claim 22, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyerfurther discloses wherein the absorbent material (184) is a
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`superabsorbent material (the absorbent layer may be a sodium polyacrylate super
`
`absorber, paragraph [0051]).
`
`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
`
`20060041247 A1) further in view of Ugander (US 20070260207 A1).
`
`Regarding claim 4, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 15
`
`Luckemeyerin view of Petrosenko doesnotdisclose wherein the manifold layer
`
`has a thickness-to-area ratio in a range of 1:(1000-2000).
`
`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 woundfor 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 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 oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerin 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 whenpressure is applied by
`
`modifying the rigidity of the structure to avoid damage to the surrounding tissue
`
`structures (Ugander, paragraphs [0010]-[0012], [(0029]-[0030)]).
`
`Regarding claim 5, Luckemeyerin view of Petrosenkofurtherin view of
`
`Ugander discloses the invention as discussed above.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 16
`
`Luckemeyerin view of Petrosenko does notdisclose wherein the thickness-to-
`
`area ratio prevents the medial collapse of the manifolding layer under the negative
`
`pressure.
`
`However, Uganderfurther 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 somewhatto the functionality of preventing deformation,
`
`wherein it is knownin the art that decreasing a dimension, such as thickness,
`
`would impart a reducedrigidity. Wherein, the barrier disc 1 is not bent, deformed,
`
`or sucked up whena negative pressure is applied, paragraph [0030)).
`
`Therefore, it would have been obvious to oneof ordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerin 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 pressure is 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, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`Luckemeyerin view of Petrosenko doesnotdisclose wherein the manifold layer
`
`has a thickness-to-area ratio in a range of 1:(1000-2000).
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 17
`
`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 woundfor 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 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. Theratio therefore being defined as .1:160, thus equivalent to
`
`1:1600).
`
`Therefore, it would have been obvious to oneofordinary skill in the art before the
`
`effective filing date of the claimed invention to have modified the manifold layerof
`
`Luckemeyerin 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)]).
`
`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 of Joshi (US 20070265585 A1).
`
`Regarding claim 6, Luckemeyerin view of Petrosenko discloses the invention
`
`as discussed above.
`
`

`

`Application/Control Number: 17/294,624
`Art Unit: 3786
`
`Page 18
`
`Luckemeyerfurther discloses wherein the dressing (124) comprising a release
`
`liner (release liner 162, paragraph [0043]) removable from the dressing (the base
`
`layer 132 may havea release liner attached to and removable therefrom).
`
`Luckemeyerin view of Petrosenko doesnot disclose the releaseliner protecting
`
`the manifold layer before the dressing is applied to the surgical wound.
`
`However, Joshi teaches an analogous wound treatment system (a system for
`
`treating surgical and other types of wounds with negative pressure therapy,
`
`paragraph [0001]) wherein the releaseliner (protective seal 16, paragraph [0029])
`
`protecting the manifold layer (woundinterface 41, paragraph [0032], wherein the
`
`wound interface 41 is placed in direct contact with the wound and is covered by
`
`the protective cover