DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 10/1/2025.
Notice of Pre-AIA 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) 1-3, 7-9, 11-33, and 41-52 is/are pending in the application.
Claim(s) 1-3, 7-9, 11-33, and 41-52 is/are examined on the merits.
Response to Arguments
Applicant’s arguments filed on 10/01/2025 have been fully considered but are moot because the independent claim(s) has/have been amended and the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 51 is objected to because of the following informalities:
In claim 51, “A wound dressing as claimed in claim 49, wherein the ECM comprises reticulum” should read -- A wound dressing as claimed in claim [[ --.
Appropriate correction is required.
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 a new ground of 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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, 7-9, 11-13, 15, 20-21, 29, 43, and 45-49 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339).
Regarding claim 1, Kazala discloses a wound dressing for applying negative pressure to a wound (a wound dressing 110: Abstract, ¶0023, 0044, Figs. 1, and 4-5), the dressing (110) comprising:
a porous bioresorbable scaffold layer (a porous bioresorbable scaffold layer 135: ¶0023, 0031-0032, 0036-0037, and Fig. 1), for placement in contact with the wound (¶0031), wherein the bioresorbable scaffold layer is configured for incorporation into the wound (¶0031 and 0036-0037);
a liquid impermeable occlusive outer layer (a cover 140 that is impermeable to liquid: ¶0038; Figs. 1 and 5);
a fluid porous porting layer positioned between the outer layer and the bioresorbable scaffold layer (a manifold 405: ¶0033, 0044, and Fig. 5; since the bioresorbable scaffold layer 135 is positioned on the tissue site, the porting layer 405 is positioned between the outer layer 140 and bioresorbable scaffold layer 135); and
a fluid conduit in fluid communication with the porting layer (a fluid conductor 470: ¶0050 and Fig. 4), for coupling to a source of negative pressure (¶0064 and Fig. 1);
wherein the porting layer comprises a multiplicity of fluid pathways between the conduit and the bioresorbable scaffold layer (the porting layer 405 is a manifold comprising a plurality of pathways: ¶0032-0033; and Fig. 5);
and wherein the bioresorbable scaffold layer comprises a plurality of apertures to enable fluid flow from the wound to the porting layer (the bioresorbable scaffold layer 135 is a manifold comprising interconnected cells or pores to enable fluid flow from the wound to the porting layer 405: ¶0033-0034).
Kazala does not disclose each aperture comprising one or more slits or slots that define one or more flaps that is movable from a closed position in which substantially all of the flap is in contact with the wound, to an open position to thereby increase the size of the respective aperture.
In the same field of endeavor, wound dressing, Locke discloses a dressing 104 for applying negative pressure to a wound (Abstract, ¶0031, and Fig. 2) comprising a porous bioresorbable scaffold layer (a bioresorbable layer 205 comprising fluid restrictions 220: ¶0054-0055 and Fig. 2). Locke further discloses each aperture comprising one or more slits or slots that define one or more flaps that is movable from a closed position in which substantially all of the flap is in contact with the wound, to an open position to thereby increase the size of the respective aperture (a fluid restriction 220 is an elastomeric valve that is normally closed when unstrained to substantially prevent liquid flow, and can open in response to a pressure gradient: ¶0055-0056).
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 wound dressing of Kazala in view Locke by making each aperture of the scaffold layer into one or more slits/slots that define one or more flaps, in order to provide a passage that is normally unstrained to reduce liquid flow and can expand or open in response to a pressure gradient, as suggested in ¶0055-0056 of Locke.
Regarding claim 7, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala does not disclose each aperture comprises two intersecting slits or slots to form a cross shape and to define one or more flaps in the bioresorbable scaffold layer, wherein the flaps are movable to increase the size of the opening provided by each aperture.
Locke further discloses/suggests one or more of the fluid restrictions 220 have shapes similar to shapes described for valves 1000 of a third layer 705 (¶0099-0100, 0137, and Figs. 10-12). Locke also discloses the valve 1000 comprises two intersecting slits or slots to form a cross shape (¶0100 and Fig. 12) and to define one or more flaps in the bioresorbable scaffold layer (¶100 and Fig. 12) and the valve 1000 has a “Y” shape (¶0100 and Fig. 11).
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 wound dressing of Kazala/Locke in view Locke by changing the shape of each aperture to comprise two intersecting slits or slots to form a cross shape and to define one or more flaps in the bioresorbable scaffold layer, in order to provide an elastic passage that is normally unstrained to substantially reduce liquid flow and can expand or open in response to a pressure gradient, as suggested in ¶0055 and 0137 of Locke and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Further, one would have been motivated to select the shape of a cross shape for each aperture in the bioabsorbable scaffold layer for the purpose of maintaining the fluid pathway allows for more efficient application of negative pressure to the wound site. Thus, the flaps of Kazala/Locke are movable to increase the size of the opening provided by each aperture.
Regarding claim 8, Kazala/Locke discloses all the limitations as discussed above for claim 7.
Kazala does not disclose the apertures are substantially X- shaped, Y-shaped, C-shaped, U-shaped, or V-shaped.
Locke further discloses/suggests the valve 1000 has a “Y” shape (¶0100 and Fig. 11).
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 wound dressing of Kazala/Locke in view of Locke by changing the shape of the apertures as claimed, in order to provide an elastic passage that is normally unstrained to substantially reduce liquid flow and can expand or open in response to a pressure gradient, as suggested in ¶0055 and 0137 of Locke and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Further, one would have been motivated to select the Y-shaped for the apertures in the bioabsorbable scaffold layer for the purpose of maintaining the fluid pathway allows for more efficient application of negative pressure to the wound site.
Regarding claim 9, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Locke further discloses the apertures are formed through the scaffold bioresorbable layer (see rejection of claim 1 above), but Kazala/Locke does not disclose the apertures are formed through the scaffold bioresorbable layer by removing a slug of material from the bioresorbable layer.
However, Examiner notes that the limitation “by removing a slug of material from the bioresorbable layer” sets forth the intended manner of making the apertures of the bioresorbable layer without adding structure to the claimed apparatus (See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115). Thus, Kazala/Locke meets the claimed limitation. In addition, a person having ordinary skill in the art would have understood/recognized that removing a slug of material from the bioresorbable layer is one of limited options to create apertures/holes of a layer.
Regarding claim 11, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala does not disclose the slits or slots are substantially X- shaped, Y-shaped, C-shaped, U-shaped, or V-shaped.
Locke discloses/suggests one or more of the fluid restrictions 220 have shapes similar to shapes described for valves 1000 of a third layer 705 (¶0099-0100, 0137, and Figs. 10-12). Locke also discloses/suggests the valve 1000 has a “Y” shape (¶0100 and Fig. 11).
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 wound dressing of Kazala/Locke in view of Locke by changing the shape of the slits/slots as claimed, in order to provide an elastic passage that is normally unstrained to substantially reduce liquid flow and can expand or open in response to a pressure gradient, as suggested in ¶0055 and 0137 of Locke and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination. (See MPEP § 2144.04 (IV) (B)). Further, one would have been motivated to select the Y-shaped for the slits/slots for the purpose of maintaining the fluid pathway allows for more efficient application of negative pressure to the wound site.
Regarding claim 12, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke discloses the bioresorbable layer comprising slits/slots (see rejection of claim 1 above), but does not disclose the slits or slots are die cut from the bioresorbable layer.
However, Examiner notes that the limitation “the slits or slots are die cut from the bioresorbable layer” sets forth the intended manner of making the slits or slots of the bioresorbable layer without adding structure to the claimed apparatus (See MPEP §§ 2112.01 (I), 2114 (I)-(II), and 2115). Thus, Kazala/Locke meets the claimed limitation. In addition, a person having ordinary skill in the art would have understood/recognized that die cutting is one of limited options to create apertures/holes of a layer.
Regarding claim 13, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the porting layer (405) comprises a fluid-permeable foam (layer 405 comprises a manifold formed from an open-cell foam, which provides a means for collecting or distributing fluid across a tissue site: ¶0033; thus, Kazala discloses the claimed limitation).
Regarding claim 15, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the porting layer (405) is compliant and porous (¶0033 and 0054).
Regarding claim 20, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the conduit (470) comprises a distal end portion having an opening in fluid communication with the porting layer (the conduit 470 comprises a distal end portion at/near a dressing interface 475 and the conduit 470 is placed over an aperture 550 to provide a fluid path between the conduit 470 and the porting layer 405: ¶0050 and Figs. 4-5).
Regarding claim 21, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the distal end portion is substantially arch-shaped (Fig. 4).
Regarding claim 29, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the occlusive layer comprises a polyurethane sheet (¶0038) comprising an adhesive surface (an adhesive: ¶0039).
Regarding claim 43, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses a negative pressure source (a negative pressure source 105: ¶0023 and Fig. 1) is coupled to the conduit (470) to apply a negative pressure to the wound (¶0025-0027).
Regarding claim 45, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the bioresorbable scaffold layer (135) comprises a multiplicity of perforations or micro-channels (a plurality of pathways or fluid channels: ¶0032-0033).
Regarding claim 46, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the application of a negative pressure between about -20mmHg and about -80mmHg (¶0027: the taught negative pressure range overlaps the claimed negative pressure range), but does not disclose the pressure drop across the dressing is less than about 1.5 mmHG.
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 wound dressing of Kazala/Locke by having the application of a negative pressure between about -20mmHg and about -80mmHg and having the pressure drop across the dressing is less than about 1.5 mmHg, motivated by the desires to provide a steady state of negative pressure differential across the wound dressing and protect the skin from irritation.
Regarding claim 47, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the application of a negative pressure between about -40mmHg (¶0027: the taught negative pressure range overlaps the claimed negative pressure range), but does not disclose the pressure drop across the dressing is less than about 1 mmHG.
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 wound dressing of Kazala/Locke by having the application of a negative pressure about -40mmHg and having the pressure drop across the dressing is less than about 1 mmHg, motivated by the desires to provide a steady state of negative pressure differential across the wound dressing and protect the skin from irritation.
Regarding claim 48, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the bioresorbable scaffold layer comprising a bioresorbable collagen-based material (¶0037).
Regarding claim 49, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala further discloses the porous bioresorbable scaffold layer is configured for cellular migration into said porous bioresorbable scaffold layer and/or cellular proliferation within said porous bioresorbable scaffold layer (the layer 135 is configured to enhance or promote the growth of cells or formation of tissue: ¶0037).
Claim(s) 2-3 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1 above, and further in view of Ward (US PGPUB 20170360544).
Regarding claim 2, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke does not disclose the bioresorbable scaffold layer comprises a plurality of mechanically interlocked bioresorbable sheets.
In an analogous art for being directed to solve the same problem, promoting regrowth and healing of damaged tissue structures, Ward discloses a bioresorbable layer (a laminated graft product 1: ¶0051, 0063, and Fig. 1) comprising a lug sheet 2 and three pierced sheets 3 (¶0063 and Fig. 1). Ward further teaches the sheets 2 and 3 of the bioresorbable layer 1 are laminated together by interlocking (¶0063) for the benefits of increasing tensile strength and maintaining structural integrity of the bioresorbable layer (¶0051-0053).
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 wound dressing of Kazala/Locke in view of Ward by making the bioresorbable scaffold layer having/comprising a plurality of mechanically interlocked bioresorbable sheets, in order to increase tensile strength and maintain structural integrity of the bioresorbable layer, as suggested in ¶0051-0053 of Ward.
Regarding claim 3, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke does not disclose the bioresorbable scaffold layer comprises a first sheet having a plurality of lugs and a second sheet having a plurality of apertures, each lug of the first sheet being located through a respective aperture in the second sheet to interlock the first sheet with the second sheet.
Ward further teaches the bioresorbable layer (the laminated graft product 1: ¶0051, 0063, and Fig. 1) comprising a first sheet having a plurality of lugs (a lug sheet 2 comprising multiple lugs: ¶0047, 0063, and Fig. 1) and a second sheet having a plurality of apertures (pierced sheet 3 comprising multiple holes: ¶0048, 0063 and Fig. 2). Ward also teaches each lug of the first sheet being located through a respective aperture in the second sheet to interlock the first sheet with the second sheet (¶0051 and 0063) for the benefits of increasing tensile strength and maintaining structural integrity of the bioresorbable layer (¶0051-0053).
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 wound dressing of Kazala/Locke in view of Ward by making the bioresorbable scaffold layer comprising a first sheet having a plurality of lugs and a second sheet having a plurality of apertures and arranging each lug of the first sheet being located through a respective aperture in the second sheet to interlock the first sheet with the second sheet, in order to increase tensile strength and maintain structural integrity of the bioresorbable layer, as suggested in ¶0051-0053 of Ward.
Claim(s) 14 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 13 above, and further in view of Ambrosio (US PGPUB 20100249688).
Regarding claim 14, Kazala/Locke discloses all the limitations as discussed above for claim 13.
Kazala further discloses the porting layer 405 comprising open-cell foam (¶0033 and 0054), but does not disclose the porting layer 405 comprising PVA foam.
In the same field of endeavor, wound dressing, Ambrosio discloses a multi-layer reduced pressure delivery apparatus is provided for applying reduced pressure tissue treatment to a tissue site (Abstract). Ambrosio further discloses polyurethane (PU) and polyvinylalcohol (PVA) foams are commonly used with negative pressure wound therapy (¶0032).
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 wound dressing of Kazala/Locke in view Ambrosio by selecting polyvinylalcohol (PVA) foam as a material for the porting layer, motivated by the desires to improve distribution or collection of fluids for negative pressure wound therapy and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 16 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1 above, and further in view of Robinson (US PGPUB 20120330253).
Regarding claim 16, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke does not disclose an upper surface of the porting layer is undulating.
In the same field of endeavor, reduced pressure system, Robinson discloses a reduced pressure system 100 comprising a distribution manifold 116 (¶0038 and Fig. 1). Robinson further teaches an upper surface of the distribution manifold 116 is undulating (an upper surface of the distribution manifold 116 comprises a plurality of peaks 120 and a plurality of notches/cuts/valleys 156: ¶0050 and Figs. 10-12) for the benefit of helping the manifold to flex or curve with a body part of the patient or with movement of the patient’s body (¶0050).
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 of the wound dressing Kazala/Locke in view of Robinson by making/having an upper surface of the porting layer being undulating, in order to help the manifold to flex or curve with a body part of the patient or with movement of the patient’s body, as suggested in ¶0050 of Robinson.
Claim(s) 17-18 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 13 above, and further in view of Long (US PGPUB 20200337906).
Regarding claim 17, Kazala/Locke discloses all the limitations as discussed above for claim 13.
Kazala/Locke does not disclose a pressure distribution layer between the porting layer and the occlusive layer.
In the same field of endeavor, negative pressure wound therapy, Long discloses a dressing 504 comprising a tissue interface 514 and a cover 516 (¶0070 and Fig. 5). Long further teaches to have multiple manifold layers (a first manifold layer 522 and a second manifold layer 524: ¶0070 and Fig. 5) between the tissue interface 514 and the cover 516 (¶0070 and Fig. 5) for the benefit of generating wicking force between manifold layers to facilitate distributing reduced pressure through layers of the wound dressing and drawing fluids or wound exudates away from the tissue site (¶0087). Thus, the first manifold layer 522 and the second manifold layer 524 are used as pressure distribution layers.
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 wound dressing of Kazala/Locke in view of Long by incorporating a pressure distribution layer between the porting layer and the occlusive layer, in order to generate wicking force between manifold layers to facilitate distributing reduced pressure through layers of the wound dressing and drawing fluids or wound exudates away from the tissue site, as suggested in ¶0087 of Long.
Regarding claim 18, Kazala/Locke/Long discloses all the limitations as discussed above for claim 17.
Kazala/Locke does not disclose the pressure distribution layer comprises an open cell foam or a three-dimensional fabric.
Long further teaches the pressure distribution layer (manifold layer 522/524) comprising an open cell foam (a porous foam material having interconnected cells or pores: ¶0034) for the benefit of improving distribution or collection of fluid across the tissue site (¶0034).
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 wound dressing of Kazala/Locke/Long in view of Long by selecting open cell foam as a material for the pressure distribution layer, in order to improve distribution or collection of fluid across the tissue site, as suggested in ¶0034 of Long and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 19 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339) and Long (US PGPUB 20200337906), as applied to claim 17 above, and further in view of Gardiner (US PGPUB 20200129338).
Regarding claim 19, Kazala/Locke/Long discloses all the limitations as discussed above for claim 17.
Kazala/Locke does not disclose the pressure distribution layer comprises a plurality of fluid flow channels that are substantially perpendicular to the interface between the porting layer and the pressure distribution layer to allow fluid to flow through the pressure distribution layer.
Long further discloses the pressure distribution layer (manifold layer 522/524) comprises a plurality of fluid flow channels (a plurality of pathways: ¶0033-0034); but does not disclose the plurality of fluid flow channels substantially perpendicular to the interface between the porting layer and the pressure distribution layer to allow fluid to flow through the pressure distribution layer.
In the same field of endeavor, wound dressing, Gardiner discloses a wound dressing 70 comprising a first foam layer 2, a second foam layer 3, and an interfacial bonding volume 4 exists between the first foam layer 2 and the second foam layer 3 (¶0140 and Fig. 3). Gardiner further teaches a plurality of channels 71 extends from the first side 35 of the first foam layer 2 through the entirety thereof and into at least a part of the second foam layer 3 (¶0140 and Fig. 3) and the plurality of channels 71 is perpendicular to the plan of the layers 2 and 3 (¶0142 and Fig. 3) for the benefit of optimizing full absorption capacity of the wound dressing (¶0143).
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 wound dressing of Kazala/Locke/Long in view of Gardiner by arranging the plurality of fluid flow channels perpendicular to the interface between the porting layer and the pressure distribution layer, in order to optimize full absorption capacity of the wound dressing, as suggested in ¶0143 of Gardiner.
Claim(s) 22-23 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 20 above, and further in view of Randolph (US PGPUB 20140276288).
Regarding claim 22, Kazala/Locke discloses all the limitations as discussed above for claim 20.
Kazala/Locke does not disclose the conduit comprises a dual lumen conduit comprising a strut positioned along a central axis of one of the lumens to prevent the conduit from collapsing under compression.
In the same field of endeavor, wound dressing, Randolph discloses a wound dressing 102 for applying vacuum to intact skin over or surrounding a tissue site (¶0025 and Figs. 1-2). Randolph further discloses/suggests the wound dressing comprising a delivery tube 425 and wherein the delivery tube 425 comprising two lumens 466 and 468 for the benefits of transferring vacuum and transporting fluid (¶0055). Furthermore, Randolph discloses/suggests the lumens 466 and 468 comprising struts positioned along a central axis of one of the lumens (protrusions 474 and 475: ¶0055 and Fig. 5) for the benefit of preventing the lumens from collapsing (¶0055-0056).
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 wound dressing of Kazala/Locke in view of Randolph by incorporating two lumens into the conduit and incorporating at least a strut/protrusion positioned along a central axis of one of the lumens, in order to transfer vacuum, transport fluid, and prevent the lumens from collapsing, as suggested in ¶0055-0056 of Randolph.
Regarding claim 23, Kazala/Locke/Randolph discloses all the limitations as discussed above for claim 22.
Kazala/Locke does not disclose at least one lumen is elliptical in shape.
Randolph further discloses/suggests that the lumens 466 and 468 have any shape such as a circular, elliptical, or polygonal shape.
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 wound dressing of Kazala/Locke/Randolph in view of Randolph by making/having at least one lumen elliptical in shape, motivated by the desires to prevent the lumens from collapsing and as it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (See MPEP § 2144.04 (IV) (B)).
Claim(s) 24 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1, and further in view of Hartwell (US PGPUB 20160106892).
Regarding claim 24, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke does not disclose the conduit is a dual lumen conduit comprising a primary conduit to apply a negative pressure to the dressing and a secondary conduit for introducing fluid to the dressing or for facilitating pressure measurement.
In the same field of endeavor, negative pressure wound therapy, Hartwell discloses a system 100 comprising a therapy unit 110 and a fluidic connector 125 is configured to provide deliver both aspiration and irrigation to the wound (¶0083 and Fig. 1A). Hartwell further teaches the system 110 comprising a conduit 120 with at least two interior channels or lumens for the benefits of providing negative pressure and supplying fluid to the wound (¶0083).
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 wound dressing of Kazala/Locke in view of Hartwell by having a conduit with two lumens, in order to provide negative pressure and supply fluid to the wound, as suggested in ¶0083 of Hartwell.
Claim(s) 25-27 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1, and further in view of Kenny (US PGPUB 20090281526 – of record).
Regarding claim 25, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke does not disclose the dressing further comprises a sleeve comprising a port for receiving a portion of the conduit therein in a secure arrangement to attach the conduit to the dressing.
In the same field of endeavor, negative pressure wound therapy, Kenny discloses a negative pressure wound therapy apparatus comprising a fluid line coupling 600. Kenny further teaches the fluid line coupling 600 comprising a sleeve (a first coupling segment 602: ¶0095) and a second coupling segment 604 having a vacuum tube 38 (¶0095 and Fig. 7A). Furthermore, Kenny discloses/suggests the first coupling segment 602 comprising a port (¶0095) for the benefits of adapting to receive the first coupling segment, forming a fluid tight interface, and permit fluid flow through first and second coupling segments (¶0095 and 0098).
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 wound dressing of Kazala/Locke in view of Kenny by incorporating a fluid line coupling having a sleeve with a port, in order to adapt to receive a conduit/tube and form a fluid tight interface, as suggested in ¶0095 and 0098 of Kenny.
Regarding claim 26, Kazala/Locke/Kenny discloses all the limitations as discussed above for claim 25.
Kazala/Locke does not disclose the sleeve comprises an elastomeric material.
Kenny further discloses/suggests the sleeve 602 comprising an elastomeric flange or skirt 606 (¶0096) for the benefit of assisting in affixing the sleeve to a wound dressing by an adhesive film overlay (¶0096).
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 wound dressing of Kazala/Locke/Kenny in view of Kenny by incorporating an elastomeric flange or skirt in the sleeve, in order to assist in affixing the sleeve to a wound dressing by an adhesive film overlay, as suggested in ¶0096 of Kenny.
Regarding claim 27, Kazala/Locke/Kenny discloses all the limitations as discussed above for claim 25.
Kazala/Locke/Kenny further discloses the sleeve forms a divider between a negative pressure receiving area of the dressing and an ambient pressure area (an area inside the sleeve and an area outside the sleeve: see rejection of claim 25 above).
Claim(s) 28 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1, and further in view of McNulty (US PGPUB 20200368072) and Mumby (US PGPUB 20170065458).
Regarding claim 28, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala/Locke does not disclose the occlusive layer comprises a substantially transparent region.
In the same field of endeavor, negative pressure wound therapy, McNulty discloses an article 10 comprising a filler 22 and an occlusive layer to cover the filler (¶0033-0034 and Figs. 4-5). McNulty further discloses/suggests the occlusive layer is transparent for the benefit of allowing for viewing of the underlying subjects (¶0034).
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 of the wound dressing of Kazala/Locke in view of McNulty by making the occlusive layer transparent, in order to allow for viewing of the underlying subjects, as suggested in ¶0034 of McNulty.
Kazala/Locke/McNulty does not disclose the porting layer comprises one or more viewing apertures to enable visual inspection of at least a portion of the bioresorbable layer.
In the same field of endeavor, negative pressure wound therapy, Mumby discloses a dressing 2100 comprising an outer layer (a cover layer 2140: ¶0372 and Fig. 15A), an absorbent layer 2110, and a porting layer (a masking or obscuring layer 2107: ¶0372 and Fig. 15A) positioned between the outer layer and the absorbent layer (Fig. 15A). Mumby further discloses/suggests the masking layer 2107 comprises any viewing windows or holes for the benefits of allowing visibility of the exudate spread below and/or viewing the state of the dressing (¶0320 and 0372).
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 of the wound dressing of Kazala/Locke/McNulty in view of Mumby by incorporating viewing windows/holes/apertures in the porting layer, in order to allow visibility of the exudate spread below and/or view the state of the dressing, as suggested in ¶0320 and 0372 of Mumby. Thus, the porting layer of Kazala in view of Locke, McNulty, and Mumby comprises one or more viewing apertures to enable visual inspection of at least a portion of the bioresorbable layer.
Claim(s) 30-33 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1, and further in view of Ramjit (US PGPUB 20140303261 – of record).
Regarding claims 30-33, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala discloses/suggests the wound dressing comprises a mouldable adhesive seal for surrounding a wound (an attachment device is a medically-acceptable, pressure-sensitive adhesive configured to bond the outer layer 140 to a surface wound and the adhesive is acrylic adhesive: ¶0039; wherein acrylic adhesive is a well-known elastomeric adhesive in the art; thus, the acrylic adhesive reads on the claimed mouldable adhesive seal).
Kazala/Locke does not disclose the seal comprises butyl rubber, a filler, and a tackifying resin; the seal is removable and re- sealable against a patient's skin; the seal is non-curing; and the seal is removable from a skin surface by stretching the adhered seal.
In an analogous art for being directed to solve the same problem, providing adhesive compositions used in medical devices, particularly in skin fixation devices, wound dressing, and/or negative pressure wound therapy (NPWT), Ramjit discloses adhesive compositions applicable to skin and their use in a medical adhesive device (¶0001-0002). Ramjit further discloses/suggests an adhesive composition comprising a complex blend of a base polymer or an elastomer such as butyl rubber or polyisobutylene rubber (¶0010, 0024, and 0064), a tackifier (¶0010, 0024, and 0031) and a filler (¶0010 and 0024) for the benefits of providing good adhesion to skin, reducing the amount of pain a patient experiences upon removal and leaving no residue (¶0006 and 0024).
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 wound dressing of Kazala/Locke in view of Ramjit by using/having an adhesive composition of butyl rubber, a filler, and a tackifying resin for the seal, in order to provide good adhesion to skin, reduce the amount of pain a patient experiences upon removal and leave no residue, as suggested in ¶0006 and 0024 of Ramjit and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07). Thus, one would have been motivated to select an adhesive composition of butyl rubber, a filler, and a tackifying resin for a sealing member of a wound dressing for the purpose of providing good adhesion to skin, reducing the amount of pain a patient experiences upon removal and leaving no residue. Since the taught composition of the seal by the composition applied above is substantially identical to Applicant’s claimed/disclosed composition of the claimed seal; thus, the seal of Kazala/Locke in view of Ramjit is capable of being removable and re- sealable against a patient's skin, non-curing, and removable from a skin surface by stretching the adhered seal.
Claim(s) 41-42 and 44 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 1, and further in view of Ramjit (US PGPUB 20140303261 – of record).
Regarding claim 41, Kazala/Locke discloses all the limitations as discussed above for claim 1.
Kazala discloses/suggests the wound dressing comprises a mouldable adhesive seal for surrounding a wound (an attachment device is a medically-acceptable, pressure-sensitive adhesive configured to bond the outer layer 140 to a surface wound and the adhesive is acrylic adhesive: ¶0039; wherein acrylic adhesive is a well-known elastomeric adhesive in the art; thus, the acrylic adhesive reads on the claimed mouldable adhesive seal).
Kazala/Locke does not disclose the seal comprises butyl rubber, a filler, and a tackifying resin.
Ramjit further discloses/suggests an adhesive composition comprising a complex blend of a base polymer or an elastomer such as butyl rubber or polyisobutylene rubber (¶0010, 0024, and 0064), a tackifier (¶0010, 0024, and 0031) and a filler (¶0010 and 0024) for the benefits of providing good adhesion to skin, reducing the amount of pain a patient experiences upon removal and leaving no residue (¶0006 and 0024).
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 wound dressing of Kazala/Locke in view of Ramjit by using/having an adhesive composition of butyl rubber, a filler, and a tackifying resin for the seal, in order to provide good adhesion to skin, reduce the amount of pain a patient experiences upon removal and leave no residue, as suggested in ¶0006 and 0024 of Ramjit and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07). Thus, one would have been motivated to select an adhesive composition of butyl rubber, a filler, and a tackifying resin for a sealing member of a wound dressing for the purpose of providing good adhesion to skin, reducing the amount of pain a patient experiences upon removal and leaving no residue.
Regarding claim 42, Kazala/Locke/Ramjit discloses all the limitations as discussed above for claim 41.
Kazala further discloses/suggests the occlusive layer is adhered over the mouldable adhesive seal (¶0039).
Regarding claim 44, Kazala/Locke/Ramjit discloses all the limitations as discussed above for claim 41.
Kazala further discloses/suggests a reservoir for collecting exudate removed from the dressing (a container 115: ¶0023, 0028, and Fig. 1).
Claim(s) 50-52 is/are rejected under 35 U.S.C 103 as being unpatentable over Kazala (US PGPUB 2019017466) in view of Locke (US PGPUB 20180353339), as applied to claim 48 above, and further in view of Ward (US PGPUB 20170360544).
Regarding claims 50-51, Kazala/Locke discloses all the limitations as discussed above for claim 48.
Kazala/Locke does not disclose the bioresorbable sheets comprise extracellular matrix (ECM) and the ECM comprises reticulum.
Ward further teaches the bioresorbable layer (the laminated graft product 1: ¶0051, 0063, and Fig. 1) comprising two or more layers of material wherein each layer comprises extracellular matrix (¶0015) and wherein the ECM comprises reticulum (¶0057) for the benefit of providing a matrix for structural integrity and a framework for carrying other materials (¶0039).
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 wound dressing of Kazala/Locke in view of Ward by making/having the bioresorbable scaffold layer comprising extracellular matrix and the ECM comprising reticulum, in order to provide a matrix for structural integrity and a framework for carrying other materials, as suggested in ¶0039 of Ward and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07). Further, one would have been motivated to select the material of the bioresorbable scaffold layer to be extracellular matrix comprising reticulum for the purpose of provide structural integrity for the wound dressing while applying negative pressure.
Regarding claims 52, Kazala/Locke/Ward discloses all the limitations as discussed above for claim 50.
Kazala further discloses the bioresorbable scaffold layer consists of a bioresorbable collagen-based material (¶0037).
Kazala/Locke/Ward further discloses the bioresorbable scaffold layer consists of ECM (see rejection of claim 50 above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/NHU Q. TRAN/Examiner, Art Unit 3781 /SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781