DETAILED ACTION
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 .
Response to Arguments
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive. Applicant argues that Jaeb does not teach the amended limitation of “a fourth layer positioned in contact with the third layer and on an opposite side of the third layer from the first layer, the fourth layer comprising a manifold.” However, as set forth in the rejection below in view of Jaeb/Zimnitsky/Locke ‘341 and the alternative rejection in view of Jaeb/Zimnitsky/Hunt, the limitation of the positioning of the fourth layer is taught by Locke ‘341 and Hunt, respectively.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 7-8, 16, 33, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1), further in view of Locke (US 20180353341 A1).
Regarding Claim 1, Jaeb discloses a dressing for treating a tissue site (reduced pressure dressing 104, Fig 3), comprising:
a first layer having at least one treatment aperture (seal layer 222 includes aperture 231, Fig 3 ¶[0054]) ;
a second layer adjacent to the first layer (interface layer 220, Fig 2), the second layer comprising a material adapted to neutralize proteolytic enzymes (220 may include collagen, which may neutralize proteolytic enzymes, Fig 3 ¶[0050]);
a third layer (first manifold layer 224, Fig 3) adjacent to the first layer, the third layer comprising a liquid impermeable polymer (224 may be made of polyurethane or a polymeric blend the same as interface layer 220 and may be hydrophobic ¶[0049][0058-0059]) having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient (224 may have pores or cells and may expand upon contact with exudate ¶[0059-0060]);
a fourth layer adjacent to the third layer and on the opposite side of the third layer from the first layer, the fourth layer comprising a manifold (second manifold layer 236 is considered adjacent to the first manifold layer 224 because it is near layer 224 and on the opposite side of layer 224 from layer 222. Furthermore, Jaeb describes adjacent layers as possibly having intervening layers in between Fig 3 ¶[0086]); and
a fifth layer adjacent to the fourth layer opposite the third layer, the fifth layer comprising a drape (drape 244, Fig 3).
Jaeb is silent whether the first layer comprises a hydrophobic gel, and whether the drape is formed from a polymer, and whether the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient, and a fourth layer comprising a manifold positioned in contact with the third layer.
However, Zimnitsky teaches a wound dressing, thus from the same field of endeavor, wherein the first layer comprises a hydrophobic gel (manifold layer 130 may include a hydrophobic gel, Fig 1 ¶[0033-0034]), and the drape is formed from a polymer (drape 132 may be formed from a polymer, Fig 1 ¶[0030]) in order to provide a pneumatic or fluid seal and to recover from an elastic deformation (¶[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 modify the system of Jaeb so that the first layer comprises a hydrophobic gel, and the drape is formed from a polymer, as taught by Zimnitsky in order to provide a pneumatic or fluid seal and to recover from an elastic deformation (as motivated by Zimnitsky ¶[0030]).
Jaeb/Zimnitsky is silent whether the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient, and a fourth layer comprising a manifold positioned in contact with the third layer.
However, Locke teaches a negative pressure wound dressing, thus from the same field of endeavor, wherein the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient (Fig 4, ¶[0058][0061-0062][0103] Layer 210 may be a polymer film with fenestrations 220 that may expand or open in response to a pressure gradient), and a fourth layer comprising a manifold positioned in contact with the third layer (Fig 4 ¶[0052] layer 205 is a manifold layer in direct contact with layer 210) in order to act as valves restricting flow in a resting state, and allowing increased liquid flow in response to a pressure gradient (¶[0062]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jaeb/Zimnitsky so that the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient, and a fourth layer comprising a manifold positioned in contact with the third layer as taught by Locke in order to act as valves restricting flow in a resting state, and allowing increased liquid flow in response to a pressure gradient (as motivated by Locke¶[0062]).
Regarding Claim 2, Jaeb/Zimnitksy/Locke discloses that the material adapted to neutralize proteolytic enzymes comprises a sacrificial substrate (interface layer 220 may comprise collagen, Fig 3 ¶[0050]. Applicant lists collagen as a possible sacrificial substrate in ¶[0007] of the instant application).
Regarding Claim 3, Jaeb/Locke is silent whether the material adapted to neutralize proteolytic enzymes comprises one or both of an enzyme sequestrator or an enzyme deactivator.
However, Zimnitsky teaches a wound dressing, thus from the same field of endeavor, wherein the material adapted to neutralize proteolytic enzymes comprises one or both of an enzyme sequestrator or an enzyme deactivator (scaffold 140 may include alpha-lipoic acid and gelatin which can regulate MMPs or a metal chelating agent capable of reducing MMP activity, such as EDTA, Fig 1 ¶[0064-0068]) in order to stimulate growth of granulation tissue, reducing infection and maintaining proper moisture balance in the wound, and removing barriers to normal healing such as abnormally high levels of MMPs (¶[0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke so that the material adapted to neutralize proteolytic enzymes comprises one or both of an enzyme sequestrator or an enzyme deactivator, as taught by Zimnitsky, in order to stimulate growth of granulation tissue, reducing infection and maintaining proper moisture balance in the wound, and removing barriers to normal healing such as abnormally high levels of MMPs (as motivated by Zimnitsky ¶[0068]).
Regarding Claim 5, Jaeb/Zimnitsky/Locke discloses that the second layer comprises a plurality of perforations (220 may comprise a porous structure, comprising a plurality of pores Fig 3 ¶[0050]).
Regarding Claim 7, Jaeb/Zimnitsky/Locke discloses that the second layer comprises a biologically-derived polymer (220 is bioresorbable and may include PLA/PGA, collagen, etc ¶[0050]).
Regarding Claim 8, Jaeb/Zimnitsky/Locke discloses that the second layer comprises one or a combination of collagen, gelatin, collagen-like proteins, collagen-like peptides, cellulose, or cellulose derivative (220 may comprise collagen, Fig 3 ¶[0050]).
Regarding Claim 16, Jaeb/Zimnitsky/Locke discloses that the second layer comprises an opening aligned with the treatment aperture (any of the plurality of pores of interface layer 220 would necessarily be aligned with aperture 231 of sealing layer 222, Fig 3 ¶[0050]).
Regarding Claim 33, Jaeb/Zimnitsky is silent whether the fluid restrictions of the third layer comprise a plurality of slots, each of the slots having a length of less than 4 mm and a width of less than 2 mm.
However, Locke teaches a negative pressure wound dressing, thus from the same field of endeavor, wherein the fluid restrictions of the third layer comprise a plurality of slots, each of the slots having a length of less than 4 mm and a width of less than 2 mm (Fig 4 ¶[0062] fluid restrictions 220 may be slot shaped with a length less than 4 mm and a width less than 1 mm) to expand and open wider in response to a pressure gradient to allow increased liquid flow (¶[0062]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jaeb/Zimnitsky/Locke so that the fluid restrictions of the third layer comprise a plurality of slots, each of the slots having a length of less than 4 mm and a width of less than 2 mm, as taught by Locke, to expand and open wider in response to a pressure gradient to allow increased liquid flow (as motivated by Locke ¶[0062]).
Regarding Claim 38, Jaeb/Zimnitsky/Locke discloses a system for treating a tissue site (reduced pressure treatment system 100, Fig 2), comprising:
the dressing of claim 1 (see above for claim 1);
and a negative-pressure source (110, Fig 2 ¶[0042]) adapted to be fluidly coupled to the dressing (104. Fig 2-3).
Claims 13, 18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1) in view of Locke (US 20180353341 A1, hereinafter Locke ‘341), further in view of Locke (US 20160038626 A1, hereinafter Locke ‘626).
Regarding Claim 13, Jaeb/Zimnitsky/Locke ‘341 is silent whether the second layer comprises collagen and oxidized regenerated cellulose.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, wherein the second layer comprises collagen and oxidized regenerated cellulose (mesh layer 414 may comprise collagen fibers 426 and oxidized regenerated cellulose (ORC) fibers 448, Fig 5 ¶[0058]) in order to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the second layer comprises collagen and oxidized regenerated cellulose, as taught by Locke ‘626 in order to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (as motivated by Locke ‘626 ¶[0063]).
Regarding Claim 18, Jaeb/Zimnitsky/Locke ‘341 is silent whether the second layer has a thickness of between 5 micrometers and 500 micrometers.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, wherein the second layer has a thickness of between 5 micrometers and 500 micrometers (mesh 414 may have a thickness between 5 and 50 micrometers, Fig 5, ¶[0045][0060]) because the tolerance of the thickness of the layer may be less than 500 micrometers, and to be adapted to the contours of deep and irregular shaped tissue sites (¶[0027][0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the second layer has a thickness of between 5 micrometers and 500 micrometers, as taught by Locke ‘626 because the tolerance of the thickness of the layer may be less than 500 micrometers, and to be adapted to the contours of deep and irregular shaped tissue sites (as motivated by Locke ‘626 ¶[0027][0045]).
Regarding Claim 20, Jaeb/Zimnitsky/Locke ‘341 is silent whether the second layer comprises approximately 20- 80% collagen and 80-20% ORC by weight.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, wherein the second layer comprises approximately 20- 80% collagen and 80-20% ORC by weight (mesh layer 414 may comprise 55% collagen and 45% ORC ¶[0062]) to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the second layer comprises approximately 20- 80% collagen and 80-20% ORC by weight, as taught by Locke ‘626 to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (as motivated by Locke ‘626 ¶[0063]).
Regarding Claim 21, Jaeb/Zimnitsky/Locke ‘341 is silent whether the second layer comprises approximately 55% collagen and 45% ORC by weight.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, the second layer comprises approximately 55% collagen and 45% ORC by weight (mesh layer 414 may comprise 55% collagen and 45% ORC ¶[0062]) to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the second layer comprises approximately 55% collagen and 45% ORC by weight, as taught by Locke ‘626 to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (as motivated by Locke ‘626 ¶[0063]).
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1) in view of Locke (US 20180353341 A1, hereinafter Locke ‘341), further in view of Hartwell (US 20160030646 A1).
Regarding Claim 14 and 17, Jaeb/Zimnitsky/Locke ‘341 discloses that the second layer (220, Fig 3) may be customized by a user to cover a particular portion of the wound, or to partially fill the wound and may be shaped as a circle, oval, or any other shape (¶[0046]). Jaeb does not explicitly disclose a ring with an opening having a width in a range of about 3 centimeters to about 35 centimeters.
However, Hartwell teaches wound fillers for negative pressure therapy, where the wound filler forms a ring (wound filler with one or more concentric rings Figs 1 and 8a-c ¶[0031-0033][0086]) with an opening having a width in a range of about 3 centimeters to about 35 centimeters (wound filler 103 is shown having concentric rings in Figs 1 and 8a-c and may be cut to an appropriate size for placement into a wound. Wound filler 103 may have an overall length of 17 inches and a width of 12 inches, thus removing the center portion would result in an opening with a width in the range of about 3 cm to at least 35 cm. ¶[0075][0089]) so the outer ring may dissolve more quickly to allow the amount of wound filler to decrease to allow the edges of the wound to come closer together (¶[0086]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the second layer forms a ring with an opening having a width in a range of about 3 centimeters to about 35 centimeters, as taught by Hartwell so the outer ring may dissolve more quickly to allow the amount of wound filler to decrease to allow the edges of the wound to come closer together (as motivated by Hartwell ¶[0086]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1) in view of Locke (US 20180353341 A1, hereinafter Locke ‘341), further in view of Agarwal (US 20180028713 A1).
Regarding Claim 23, Jaeb/Zimnitsky/Locke ‘341 is silent whether the material adapted to neutralize proteolytic enzymes is present at a higher concentration in a perimeter portion than at a center portion of the second layer.
However, Agarwal teaches polymer layers for use in wound healing, thus from the same field of endeavor, wherein the material adapted to neutralize proteolytic enzymes (enzyme inhibitors are possible bioactive agents that may be included in the polymer layer envisioned by Agarwal ¶[0088][0095]) is present at a higher concentration in a perimeter portion than at a center portion of the second layer (the bioactive agent may have a concentration gradient wherein there is a lower concentration in the center of the layer which transitions to a higher concentration at the periphery of the layer, such as a circular gradient ¶[0091]) so that the matrix and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the material adapted to neutralize proteolytic enzymes is present at a higher concentration in a perimeter portion than at a center portion of the second layer, as taught by Agarwal so that the layer and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (as motivated by Agarwal ¶[0091]).
Regarding Claim 24, Jaeb/Zimnitsky/Locke ‘341 is silent whether the material adapted to neutralize proteolytic enzymes is present in a concentration having a circular gradient increasing from a center portion of the second layer to a perimeter of the second layer.
However, Agarwal teaches polymer layers for use in wound healing, thus from the same field of endeavor, wherein the material adapted to neutralize proteolytic enzymes (enzyme inhibitors are possible bioactive agents that may be included in the polymer layer envisioned by Agarwal ¶[0088][0095]) is present in a concentration having a circular gradient increasing from a center portion of the second layer to a perimeter of the second layer (the bioactive agent may have a concentration gradient wherein there is a lower concentration in the center of the layer which transitions to a higher concentration at the periphery of the layer, such as a circular gradient ¶[0091]) so that the matrix and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Locke ‘341 so that the material adapted to neutralize proteolytic enzymes is present in a concentration having a circular gradient increasing from a center portion of the second layer to a perimeter of the second layer, as taught by Agarwal so that the matrix and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (as motivated by Agarwal ¶[0091]).
Alternatively, Claims 1-3, 5, 7-8, 16, 33, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1), further in view of Hunt (US 20040030304 A1).
Regarding Claim 1, Jaeb discloses a dressing for treating a tissue site (reduced pressure dressing 104, Fig 3), comprising:
a first layer having at least one treatment aperture (seal layer 222 includes aperture 231, Fig 3 ¶[0054]) ;
a second layer adjacent to the first layer (interface layer 220, Fig 2), the second layer comprising a material adapted to neutralize proteolytic enzymes (220 may include collagen, which may neutralize proteolytic enzymes, Fig 3 ¶[0050]);
a third layer (first manifold layer 224, Fig 3) adjacent to the first layer, the third layer comprising a liquid impermeable polymer (224 may be made of polyurethane or a polymeric blend the same as interface layer 220 and may be hydrophobic ¶[0049][0058-0059]) having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient (224 may have pores or cells and may expand upon contact with exudate ¶[0059-0060]);
a fourth layer adjacent to the third layer and on the opposite side of the third layer from the first layer, the fourth layer comprising a manifold (second manifold layer 236 is considered adjacent to the first manifold layer 224 because it is near layer 224 and on the opposite side of layer 224 from layer 222. Furthermore, Jaeb describes adjacent layers as possibly having intervening layers in between Fig 3 ¶[0086]); and
a fifth layer adjacent to the fourth layer opposite the third layer, the fifth layer comprising a drape (drape 244, Fig 3).
Jaeb is silent whether the first layer comprises a hydrophobic gel, and whether the drape is formed from a polymer, and whether the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient, and a fourth layer comprising a manifold positioned in contact with the third layer.
However, Zimnitsky teaches a wound dressing, thus from the same field of endeavor, wherein the first layer comprises a hydrophobic gel (manifold layer 130 may include a hydrophobic gel, Fig 1 ¶[0033-0034]), and the drape is formed from a polymer (drape 132 may be formed from a polymer, Fig 1 ¶[0030]) in order to provide a pneumatic or fluid seal and to recover from an elastic deformation (¶[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 modify the system of Jaeb so that the first layer comprises a hydrophobic gel, and the drape is formed from a polymer, as taught by Zimnitsky in order to provide a pneumatic or fluid seal and to recover from an elastic deformation (as motivated by Zimnitsky ¶[0030]).
Jaeb/Zimnitsky is silent whether the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient, and a fourth layer comprising a manifold positioned in contact with the third layer.
However, Hunt teaches a negative pressure wound dressing, thus from the same field of endeavor, wherein the third layer comprises a polymer film having a plurality of fluid restrictions (Fig 1 ¶[0021][0030][0033] upper elastomeric sheet 28 may be a polymer film and is an intermediate fluid distributing layer comprising a plurality of holes 32) that are configured to expand in response to a pressure gradient (Fig 1 ¶[0021][0030][0033] elastomeric sheet 28 may be made of the same polymer film materials listed for Applicant’s third layer 215 (Applicant’s specification [0060-0061] and elastomeric sheet 28 has holes 32 that may be a similar size to Applicant’s fluid restrictions 255 (Applicant’s specification [0064]. Hunt teaches in ¶[0033] that the length of the holes or slits may be 3 mm). Applicant describes the third layer’s ability to expand in response to a pressure gradient as a result of the polymer film material and the size of the fenestrations (Applicant’s specification [0064]). Thus the plurality of holes 32 in the elastomeric sheet 28 of Hunt are fully capable of expanding in response to a pressure gradient), and a fourth layer comprising a manifold positioned in contact with the third layer (Fig 1 ¶[0038] upper foam layer 12 is in direct contact with sheet 28 and disperses vacuum within the dressing 10, thus acting as a manifold) in order to disperse vacuum flow to prevent clogging of the dressing medium (¶[0037]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jaeb/Zimnitsky so that the third layer comprises a polymer film having a plurality of fluid restrictions that are configured to expand in response to a pressure gradient, and a fourth layer comprising a manifold positioned in contact with the third layer, as taught by Hunt in order to disperse vacuum flow to prevent clogging of the dressing medium (as motivated by Hunt ¶[0037]).
Regarding Claim 2, Jaeb/Zimnitksy/Hunt discloses that the material adapted to neutralize proteolytic enzymes comprises a sacrificial substrate (interface layer 220 may comprise collagen, Fig 3 ¶[0050]. Applicant lists collagen as a possible sacrificial substrate in ¶[0007] of the instant application).
Regarding Claim 3, Jaeb/Hunt is silent whether the material adapted to neutralize proteolytic enzymes comprises one or both of an enzyme sequestrator or an enzyme deactivator.
However, Zimnitsky teaches a wound dressing, thus from the same field of endeavor, wherein the material adapted to neutralize proteolytic enzymes comprises one or both of an enzyme sequestrator or an enzyme deactivator (scaffold 140 may include alpha-lipoic acid and gelatin which can regulate MMPs or a metal chelating agent capable of reducing MMP activity, such as EDTA, Fig 1 ¶[0064-0068]) in order to stimulate growth of granulation tissue, reducing infection and maintaining proper moisture balance in the wound, and removing barriers to normal healing such as abnormally high levels of MMPs (¶[0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the material adapted to neutralize proteolytic enzymes comprises one or both of an enzyme sequestrator or an enzyme deactivator, as taught by Zimnitsky, in order to stimulate growth of granulation tissue, reducing infection and maintaining proper moisture balance in the wound, and removing barriers to normal healing such as abnormally high levels of MMPs (as motivated by Zimnitsky ¶[0068]).
Regarding Claim 5, Jaeb/Zimnitsky/Hunt discloses that the second layer comprises a plurality of perforations (220 may comprise a porous structure, comprising a plurality of pores Fig 3 ¶[0050]).
Regarding Claim 7, Jaeb/Zimnitsky/Hunt discloses that the second layer comprises a biologically-derived polymer (220 is bioresorbable and may include PLA/PGA, collagen, etc ¶[0050]).
Regarding Claim 8, Jaeb/Zimnitsky/Hunt discloses that the second layer comprises one or a combination of collagen, gelatin, collagen-like proteins, collagen-like peptides, cellulose, or cellulose derivative (220 may comprise collagen, Fig 3 ¶[0050]).
Regarding Claim 16, Jaeb/Zimnitsky/Hunt discloses that the second layer comprises an opening aligned with the treatment aperture (any of the plurality of pores of interface layer 220 would necessarily be aligned with aperture 231 of sealing layer 222, Fig 3 ¶[0050]).
Regarding Claim 33, Jaeb/Zimnitsky is silent whether the fluid restrictions of the third layer comprise a plurality of slots, each of the slots having a length of less than 4 mm and a width of less than 2 mm.
However, Hunt teaches a negative pressure wound dressing, thus from the same field of endeavor, wherein the fluid restrictions of the third layer comprise a plurality of slots, each of the slots having a length of less than 4 mm and a width of less than 2 mm (Fig 1 ¶[0033] plurality of holes 32 in the elastomeric layer 28 may be slit or slot shaped, and have a length of 3 mm. A slit is commonly defined as a long, narrow cut or opening (Merriam-Webster) and thus a slit having a length of 3 mm would have a relatively smaller width than length, thus Hunt envisions a slit width less than 2 mm), in order to disperse vacuum flow to prevent clogging of the dressing medium (¶[0037]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jaeb/Zimnitsky/Hunt so that the fluid restrictions of the third layer comprise a plurality of slots, each of the slots having a length of less than 4 mm and a width of less than 2 mm, as taught by Hunt, in order to disperse vacuum flow to prevent clogging of the dressing medium (as taught by Hunt ¶[0037]).
Regarding Claim 38, Jaeb/Zimnitsky/Hunt discloses a system for treating a tissue site (reduced pressure treatment system 100, Fig 2), comprising:
the dressing of claim 1 (see above for claim 1);
and a negative-pressure source (110, Fig 2 ¶[0042]) adapted to be fluidly coupled to the dressing (104. Fig 2-3).
Claims 13, 18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1) in view of Hunt (US 20040030304 A1), further in view of Locke (US 20160038626 A1, hereinafter Locke ‘626).
Regarding Claim 13, Jaeb/Zimnitsky/Hunt is silent whether the second layer comprises collagen and oxidized regenerated cellulose.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, wherein the second layer comprises collagen and oxidized regenerated cellulose (mesh layer 414 may comprise collagen fibers 426 and oxidized regenerated cellulose (ORC) fibers 448, Fig 5 ¶[0058]) in order to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the second layer comprises collagen and oxidized regenerated cellulose, as taught by Locke ‘626 in order to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (as motivated by Locke ‘626 ¶[0063]).
Regarding Claim 18, Jaeb/Zimnitsky/Hunt is silent whether the second layer has a thickness of between 5 micrometers and 500 micrometers.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, wherein the second layer has a thickness of between 5 micrometers and 500 micrometers (mesh 414 may have a thickness between 5 and 50 micrometers, Fig 5, ¶[0045][0060]) because the tolerance of the thickness of the layer may be less than 500 micrometers, and to be adapted to the contours of deep and irregular shaped tissue sites (¶[0027][0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the second layer has a thickness of between 5 micrometers and 500 micrometers, as taught by Locke ‘626 because the tolerance of the thickness of the layer may be less than 500 micrometers, and to be adapted to the contours of deep and irregular shaped tissue sites (as motivated by Locke ‘626 ¶[0027][0045]).
Regarding Claim 20, Jaeb/Zimnitsky/Hunt is silent whether the second layer comprises approximately 20- 80% collagen and 80-20% ORC by weight.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, wherein the second layer comprises approximately 20- 80% collagen and 80-20% ORC by weight (mesh layer 414 may comprise 55% collagen and 45% ORC ¶[0062]) to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the second layer comprises approximately 20- 80% collagen and 80-20% ORC by weight, as taught by Locke ‘626 to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (as motivated by Locke ‘626 ¶[0063]).
Regarding Claim 21, Jaeb/Zimnitsky/Hunt is silent whether the second layer comprises approximately 55% collagen and 45% ORC by weight.
However, Locke ‘626 teaches a protease modulating wound interface layer for use with negative pressure therapy, thus from the same field of endeavor, the second layer comprises approximately 55% collagen and 45% ORC by weight (mesh layer 414 may comprise 55% collagen and 45% ORC ¶[0062]) to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (¶[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the second layer comprises approximately 55% collagen and 45% ORC by weight, as taught by Locke ‘626 to allow the mesh layer to swell and disperse into the manifold to provide MMP modulation, elastase modulation, and bacteria protease modulation without restricting the flow of negative-pressure to the tissue site (as motivated by Locke ‘626 ¶[0063]).
Claims 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1) in view of Hunt (US 20040030304 A1), further in view of Hartwell (US 20160030646 A1).
Regarding Claim 14 and 17, Jaeb discloses that the second layer (220, Fig 3) may be customized by a user to cover a particular portion of the wound, or to partially fill the wound and may be shaped as a circle, oval, or any other shape (¶[0046]). Jaeb does not explicitly disclose a ring with an opening having a width in a range of about 3 centimeters to about 35 centimeters.
However, Hartwell teaches wound fillers for negative pressure therapy, where the wound filler forms a ring (wound filler with one or more concentric rings Figs 1 and 8a-c ¶[0031-0033][0086]) with an opening having a width in a range of about 3 centimeters to about 35 centimeters (wound filler 103 is shown having concentric rings in Figs 1 and 8a-c and may be cut to an appropriate size for placement into a wound. Wound filler 103 may have an overall length of 17 inches and a width of 12 inches, thus removing the center portion would result in an opening with a width in the range of about 3 cm to at least 35 cm. ¶[0075][0089]) so the outer ring may dissolve more quickly to allow the amount of wound filler to decrease to allow the edges of the wound to come closer together (¶[0086]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the second layer forms a ring with an opening having a width in a range of about 3 centimeters to about 35 centimeters, as taught by Hartwell so the outer ring may dissolve more quickly to allow the amount of wound filler to decrease to allow the edges of the wound to come closer together (as motivated by Hartwell ¶[0086]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Jaeb (US 20090227969 A1) in view of Zimnitsky (US 20110251566 A1) in view of Hunt (US 20040030304 A1), further in view of Agarwal (US 20180028713 A1).
Regarding Claim 23, Jaeb/Zimnitsky/Hunt is silent whether the material adapted to neutralize proteolytic enzymes is present at a higher concentration in a perimeter portion than at a center portion of the second layer.
However, Agarwal teaches polymer layers for use in wound healing, thus from the same field of endeavor, wherein the material adapted to neutralize proteolytic enzymes (enzyme inhibitors are possible bioactive agents that may be included in the polymer layer envisioned by Agarwal ¶[0088][0095]) is present at a higher concentration in a perimeter portion than at a center portion of the second layer (the bioactive agent may have a concentration gradient wherein there is a lower concentration in the center of the layer which transitions to a higher concentration at the periphery of the layer, such as a circular gradient ¶[0091]) so that the matrix and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the material adapted to neutralize proteolytic enzymes is present at a higher concentration in a perimeter portion than at a center portion of the second layer, as taught by Agarwal so that the layer and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (as motivated by Agarwal ¶[0091]).
Regarding Claim 24, Jaeb/Zimnitsky/Hunt is silent whether the material adapted to neutralize proteolytic enzymes is present in a concentration having a circular gradient increasing from a center portion of the second layer to a perimeter of the second layer.
However, Agarwal teaches polymer layers for use in wound healing, thus from the same field of endeavor, wherein the material adapted to neutralize proteolytic enzymes (enzyme inhibitors are possible bioactive agents that may be included in the polymer layer envisioned by Agarwal ¶[0088][0095]) is present in a concentration having a circular gradient increasing from a center portion of the second layer to a perimeter of the second layer (the bioactive agent may have a concentration gradient wherein there is a lower concentration in the center of the layer which transitions to a higher concentration at the periphery of the layer, such as a circular gradient ¶[0091]) so that the matrix and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (¶[0091]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Jaeb/Zimnitsky/Hunt so that the material adapted to neutralize proteolytic enzymes is present in a concentration having a circular gradient increasing from a center portion of the second layer to a perimeter of the second layer, as taught by Agarwal so that the matrix and gradient can conform to a variety of wound shapes such as open type wounds, burns sores, and ulcers that are circular or oval (as motivated by Agarwal ¶[0091]).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781