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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/15/2026 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendments made to claims 48, 87, 95, and 99 in the response filed on 7/15/2026 are acknowledged. Claims 48-49, 52, 57, and 87-101 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see pages 5-6, filed 7/15/2026, with respect to the rejection of claim 48 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “In an effort to advance prosecution and to further clarify the distinctions between the present application the cited prior art, Applicant amended Claim 48 to now recite, inter alia, "a masking element above the acquisition distribution layer, the masking element configured to at least partially prevent visualization of a layer therebelow and to change an indication when in contact with nitric oxide." Applicant respectfully submits that the cited references, considered either alone or in combination, do not disclose, suggest, or render obvious all the features of amended Claim 48”; however, examiner respectfully disagrees. In Allen et al., it teaches that the masking layer or obscuring layer is the colored portion of the absorbent material or a separate layer that covers the absorbent material. Since the masking layer or obscuring layer can be the colored portion of the absorbent material, the absorbent itself is the masking element which can prevent visualization of a layer therebelow (paragraph 0193 of Allen et al.). Additionally, since the absorbent material is made of ALLEVYN.TM. foam, which is made of polyurethane [as evidenced by “SMTL”], the absorbent material is capable of changing an indication when in contact with nitric oxide, as stated in the instant application’s written specification. It was disclosed that polyurethane “changes color in contact with nitric oxide or nitrogen dioxide” in paragraph 0174 of the written specification; therefore, it is inherent that the ALLEVYN.TM. foam of Allen et al. will change indication when in contact with nitric oxide (paragraph 0190 of Allen et al.). Therefore, Allen et al. still reads on the newly amended claim 48.
Applicant argues “Applicant respectfully notes that one of skill in the art would not have expected Allen's multi-layer absorbent layer stacked arrangement to be incorporated into Wood's two-component nitrite/hydrogen-ion dressing without changing the principle of operation of Wood. For at least these reasons, Applicant respectfully submits that Claim 48 is patentable over the cited references”; however, examiner respectfully disagrees. Wood’s is a wound dressing that is analogous to the wound dressing of Allen et al. (both are placed on wound sites). By teaching the acquisition distribution layer and masking element into Wood’s wound dressing, it provides an improved wound dressing that increases moisture vapor permeation and to enable clinicians to perceive a different color caused by exudate, blood, by-products, etc. in the dressing to allow visual assessment and monitoring of the spread across the dressing (paragraph 0189/0195, Allen et al.).
Applicant's arguments, see page 6, filed 7/15/2026, with respect to the rejection of claims 87 and 99 under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments below.
Applicant argues “In an effort to advance prosecution and to further clarify the distinctions between the present application the cited prior art, Applicant amended Claim 87 to now recite, inter alia, "an acid providing layer positioned below the cover layer, comprising acidic groups, wherein the acid providing layer comprises one or more immobilized material layers, at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound, the one or more material layers comprising a non-woven material." Further Claim 99, has been amended to now recite, inter alia, "an acid providing layer positioned below the cover layer, comprising acidic groups, wherein the acid providing layer comprises one or more immobilized material layers, at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound." Applicant respectfully submits that the cited references, considered either alone or in combination, do not disclose, suggest, or render obvious all the features of amended Claims 87 and 99. To reach the limitations of Claims 87 and 99, the Office Action combined Wood with Bishop/Andrews or with Waite using the rationale of improved mechanical strength or breathability. However, the solid layer of Wood is described as within the hydrogel, which would not reduce adhesion of the acid-providing layer. For at least these reasons, Applicant respectfully submits that Claims 87 and 99 are patentable over the cited references”; however, examiner respectfully disagrees (any argument in regard to Bishop is now moot due to a new combination of arts to reject claim 87). Although Wood et al. does not disclose how at least one material layer would reduce adhesion of the acid providing layer to the wound, Munro et al. teaches for claim 87 wherein an analogous acid providing layer (2 – figure 5, islands of hydrogel: paragraph 0103) comprises one or more immobilized material layers (3/5 – figure 5, a supporting layer [3] that can comprise of a scrim and an absorbent layer [5]: paragraph 0020/0103), at least one material layer (4 – figure 5, a layer of adhesive: paragraph 0103) positioned on a surface of the analogous acid providing layer (figure 5, the at least one material layer [4] is on a surface of the acid providing layer: paragraph 0053/0103) and configured to reduce adhesion of the acid providing layer (2) to the wound (the at least one material layer [4] is on the surface of the acid providing layer facing the wound site; since there is at least one material layer [4] between the acid providing layer [2] and the wound site, it reduces the adhesion of the acid providing layer [2] to the wound [see examiner further notes below: paragraph 0053), the one or more material layers (3/5) comprising a non-woven material (the one or more material [3/5] comprising supporting layer [3] can be woven, nonwoven, or net [mesh]: paragraph 0020). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, for claim 99, Waite teaches a cover layer (102 – figure 6, a backing layer: paragraph 0023) configured to form a seal around the wound (the cover layer [102] adheres to the skin around the peri-wound: paragraph 0025); and an analogous acid providing layer (106 – figure 6, superabsorbent layer made of hydrogel or hydrogel composition: paragraph 0031) positioned below the cover layer (102) (figure 6, the acid providing layer [106] is below the cover layer [102]), at least one material layer (108 – figure 6, a second elastic foam layer that contacts the wound site: paragraph 0037) positioned on a surface of the analogous acid providing layer (figure 6, the at least one material layer [108] is positioned on a surface of the acid providing layer [106]) and configured to reduce adhesion of the acid providing layer (106) to the wound (figure 6, since the at least one material layer [108] is between the wound site and the acid providing layer [106], the at least one material layer [108] reduces the adhesion of the acid providing layer [106] to the wound). Therefore, Munro et al. and Waite et al. still reads on claim 87 and 99, respectively.
Applicant's arguments, see page 7, filed 7/15/2026, with respect to the rejection of the dependent claims under 35 U.S.C. 103 have been fully considered but are not persuasive. Please see arguments above.
Claim Objections
Claim 87 objected to because of the following informalities: “the one or more material layers” should be “the one or more immobilized material layers” in line 8. Appropriate correction is required.
Claim 87 objected to because of the following informalities: “the thickness of the acid providing layer” should be “[[the]] a thickness of the acid providing layer” in lines 9-10. Appropriate correction is required.
Claim 88 objected to because of the following informalities: “the one or more material layers” should be “the one or more immobilized material layers” in lines 1-2. Appropriate correction is required.
Claim 89 objected to because of the following informalities: “the one or more material layers” should be “the one or more immobilized material layers” in lines 1-2. Appropriate correction is required.
Claim 90 objected to because of the following informalities: “the one or more material layers” should be “the one or more immobilized material layers” in lines 1-2. Appropriate correction is required.
Claim 93 objected to because of the following informalities: “the one or more material layers” should be “the one or more immobilized material layers” in line 2. Appropriate correction is required.
Claim 94 objected to because of the following informalities: “the one or more material layers” should be “the one or more immobilized material layers” in line 2. Appropriate correction is required.
Claim 97 objected to because of the following informalities: “wherein at least one of the one or more material layers” should be “wherein at least one of the one or more immobilized material layers” in lines 1-2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 87, 91-92, 95, and 99 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 88-90, 93-94, and 96-98 are also rejected due to their dependency on claim 87. Additionally, claims 100-101 are rejected due to their dependency on claim 99.
Regarding claim 87, the limitation “at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound” is unclear. Examiner is unsure whether the one material layer is between the acid providing layer’s surface and the wound; if so, how does the acid providing layer adhere to the wound in the first place (what is the one material layer)? Examiner examined this claim as best understood.
Regarding claim 91, the limitation “wherein the acid providing layer comprises one material layer” is unclear. Examiner is unsure whether it is referring back to the one material layer in claim 87 or if claim 91 is introducing a new one material layer. Examiner examined this claim as best understood.
Regarding claim 92, the limitation “wherein the acid providing layer comprises one material layer” is unclear. Examiner is unsure whether it is referring back to the one material layer in claim 87 or if claim 92 is introducing a new one material layer. Examiner examined this claim as best understood.
Regarding claim 95, the limitation “wherein one or more material layers” is unclear. Examiner is unsure whether it is referring back to the one or more embedded material layer in claim 87 or if claim 95 is introducing a new one or more embedded material layer. Examiner examined this claim as best understood.
Regarding claim 99, the limitation “at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound” is unclear. Examiner is unsure whether the one material layer is between the acid providing layer’s surface and the wound; if so, how does the acid providing layer adhere to the wound in the first place (what is the one material layer)? Examiner examined this claim as best understood.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 48-49, 52, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (US 20160089473 A1) in view of Allen et al. (US 20150216733 A1), with extrinsic evidence provided by “SMTL” for the rejection of claim 48.
Regarding claim 48, Wood et al. discloses a wound dressing (figure 1, a two component dressing system: paragraph 0008-0012) for treating a wound (the wound dressing [figure 1] is applied to wounds: paragraph 0007), comprising: one or more nitric oxide generating layers (the wound dressing [figure 1] comprises two layers: a layer containing nitrite salt [such as a mesh] and a hydrogel [absorbent] that contains hydrogen ions; when the two layers are placed into contact with each other, a chemical reaction takes place to produce nitric oxide: paragraph 0008-0012/0019).
However, Wood et al. fails to disclose an acquisition distribution layer; and a masking element above the acquisition distribution layer, the masking element configured to at least partially prevent visualization of a layer therebelow and to change an indication when in contact with nitric oxide.
Allen et al. teaches an analogous wound dressing (3400 – figure 34A, a wound dressing: paragraph 0185-0186), an acquisition distribution layer (3440 – figure 34A, an acquisition distribution layer: paragraph 0189); and a masking element (3420/3430 - figure 34A, a masking or obscuring layer [3420] that is the colored portion of the absorbent material [3430]; the absorbent material itself is the masking element: paragraph 0185/0193) above the acquisition distribution layer (3440) (figure 34A, the masking element [3420/3430] is above the acquisition distribution layer [3440]), the masking element (3420) configured to at least partially prevent visualization of a layer there below (figure 34A, the masking element [3420/3430] helps reduce the unsightly appearance of the dressing [3400] and the layers below the masking element [3420/3430] [see examiner further notes]: paragraph 0193) and to change an indication when in contact with nitric oxide (the absorbent material comprising the colored portion is made of ALLEVYN.TM. foam, which is made of polyurethane [as evidenced by “SMTL”]; in the written specification, it was disclosed that polyurethane “changes color in contact with nitric oxide or nitrogen dioxide” in paragraph 0174. Therefore, it is inherent that the ALLEVYN.TM. foam of Allen will change indication when in contact with nitric oxide [see examiner further notes]: paragraph 0190).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the wound dressing of Wood et al. with an acquisition distribution layer and a masking element above the acquisition distribution layer as taught by Allen et al. in order to provide an improved wound dressing that increases moisture vapor permeation and to enable clinicians to perceive a different color caused by exudate, blood, by-products, etc. in the dressing to allow visual assessment and monitoring of the spread across the dressing (paragraph 0189/0195, Allen et al.).
Regarding claim 49, Wood et al. in view of Allen et al. discloses the invention as discussed in claim 48. Wood et al. further discloses a cover layer (the hydrogel layer can comprise a barrier layer, such as a polyurethane film on the surface exposed to the air when the wound dressing is in use: paragraph 0054). Allen et al. further teaches wherein the analogous wound dressing (3400 - figure 34A, a wound dressing: paragraph 0185) further comprises an analogous cover layer (3410 - figure 34A, a backing layer: paragraph 0185), and wherein the masking element (3420) is positioned below the analogous cover layer (3410) (figure 34A, the masking element [3420] is below the cover layer [3410]).
Regarding claim 52, Wood et al. in view of Allen et al. discloses the invention as discussed in claim 48.
However, Wood et al. in view of Allen et al. fails to disclose wherein the masking element comprises one or more viewing windows.
Allen et al. further teaches wherein the masking element (3420/3430) comprises one or more viewing windows (the masking element [3420/3430] can be provided with one or more viewing windows: paragraph 0122).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the masking element of Wood et al. in view of Allen et al. with one or more viewing windows as taught by Allen et al. in order to provide an improved wound dressing that allows visual assessment of the spread of exudate in the layers below the masking element in the dressing (paragraph 0201, Allen et al.).
Regarding claim 57, Wood et al. in view of Allen et al. discloses the invention as discussed in claim 48. Wood et al. discloses wherein the nitric oxide generating layers comprise a nitrite providing layer comprising a nitrite salt (the nitric oxide generating layers comprises a layer with nitrite salt in solid or solution form; typically, the nitrite is in the form of a nitrite solution: paragraph 0019).
Claims 87-93 and 95-97 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (US 20160089473 A1) in view of Munro et al. (US 20160250373 A1) and in further view of Andrews (US 20190262185 A1).
Regarding claim 87, Wood et al. discloses Wood et al. discloses a wound dressing (figure 1, a two component dressing system: paragraph 0008-0012) for treating a wound (the wound dressing [figure 1] is applied to wounds: paragraph 0007), comprising: a cover layer (the wound dressing [figure 1] can have a barrier layer, such as a polyurethane film or an adhesive coated polyurethane film on the surface facing away from the wound site; this barrier layer provides a bacterial barrier: paragraph 0054) configured to form a seal around the wound (the cover layer is capable of forming a seal around the wound); a nitrite providing layer comprising a nitrite salt (the wound dressing comprises a layer containing nitrite salt: paragraph 0008-0012/0019); and an acid providing layer (a hydrogel absorbent that contains hydrogen ions: paragraph 0008-0012) positioned below the cover layer (the acid providing layer is placed in direct contact with the skin and has a cover layer on the surface facing away from the wound site: paragraph 0007-0012), comprising acidic groups (the acid providing layer contains hydrogen ions: paragraph 0010)
However, Wood et al. fails to disclose wherein the acid providing layer comprises one or more immobilized material layers, at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound, the one or more material layers comprising a non-woven material, and wherein the acid providing layer further comprises one or more holes through the thickness of the acid providing layer.
Munro et al. teaches wherein an analogous acid providing layer (2 – figure 5, islands of hydrogel: paragraph 0103) comprises one or more immobilized material layers (3/5 – figure 5, a supporting layer [3] that can comprise of a scrim and an absorbent layer [5]: paragraph 0020/0103), at least one material layer (4 – figure 5, a layer of adhesive: paragraph 0103) positioned on a surface of the analogous acid providing layer (figure 5, the at least one material layer [4] is on a surface of the acid providing layer: paragraph 0053/0103) and configured to reduce adhesion of the acid providing layer (2) to the wound (the at least one material layer [4] is on the surface of the acid providing layer facing the wound site; since there is at least one material layer [4] between the acid providing layer [2] and the wound site, it reduces the adhesion of the acid providing layer [2] to the wound [see examiner further notes below: paragraph 0053), the one or more material layers (3/5) comprising a non-woven material (the one or more material [3/5] comprising supporting layer [3] can be woven, nonwoven, or net [mesh]: paragraph 0020).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the acid providing layer of Wood et al. to comprise one or more material layers, at least one material layer positioned on a surface of the acid providing layer, and the one or more material layers comprising a non-woven material as taught by Munro et al. in order to provide a wound dressing that has an improved acid providing layer in which the one or more material enhances the mechanical strength of the wound dressing and the at least one material layer maintain structural integrity of the wound dressing (paragraph 0018-0019/0089, Munro et al.).
However, Wood et al. in view of Munro et al. fails to disclose wherein the acid providing layer further comprises one or more holes through the thickness of the acid providing layer.
Andrews teaches wherein an analogous acid providing layer (101 – figure 2, a layer of hydrogel: paragraph 0118) further comprises one or more holes (102 – figure 2, apertures extending through the acid providing layer [101]: paragraph 0118) through the thickness of the analogous acid providing layer (101) (figure 2, the acid providing layer [101] has one or more holes [102] extending therethrough: paragraph 0118).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the acid providing layer of Woods et al. in view of Munro et al. with one or more holes through the thickness of the acid providing layer as taught by Andrews in order to provide a wound dressing that has an improved acid providing layer that enables a moist wound environment to be maintained for prolonged periods over a wide range of wound exudation rate (paragraph 0043, Andrews).
Regarding claim 88, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the one or more material layers (3/5) comprise woven material (the one or more material layers [3/5] comprising the supporting layer [3] can be woven: paragraph 0020).
Regarding claim 89, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the one or more material layers (3/5) comprise a mesh (the one or more material layers [3/5] comprising the supporting layer [3] can be a net [mesh]: paragraph 0020).
Regarding claim 90, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the one or more material layers (3/5) comprise polypropylene, polyethylene, or a combination thereof (the one or more material layers [3/5] comprising the supporting layer [3] can be made of polyethylene, polypropylene, nylon, etc.: paragraph 0020/0089).
Regarding claim 91, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the analogous acid providing layer (2) comprises one material layer (3/5), wherein the one material layer (3/5) covers a lower wound-facing side of the acid providing layer (A – see annotated figure 1, wound-facing side of the acid providing layer) (figure 2, the one material layer [3/5] comprising the absorbent layer [5] is on the wound facing side of the acid providing layer [A]: paragraph 0030).
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Annotated figure 1: cross section of the hydrogel dressing with one or more materials
Regarding claim 92 Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein an analogous acid providing layer (2) comprises one material layer (3/5), wherein the one analogous material layer (3/5) covers an upper side of the acid providing layer (B – see annotated figure 1, upper side of the acid providing layer facing away from the wound) opposite a wound facing side (see annotated figure 1, the material layer [3/5] comprising the supporting layer [3] can be on a non-wound facing side [B]: paragraph 0031).
Regarding claim 93, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the analogous acid providing layer (2) is sandwiched between the one or more material layers (3/5) (figure 5, the acid providing layer [2] is sandwiched between the absorbent layer [5] and the supporting layer [3]).
Regarding claim 95, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the one or more material layers (3/5) are embedded within the analogous acid providing layer (2) (figure 2, the one or more materials layers [3] can be embedded within the acid providing layer [2]: paragraph 0020-0021/0030-0031).
Regarding claim 96, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Wood et al. further discloses wherein the acid providing layer comprises Xerogel or hydrogel (the acid providing layer comprises a hydrogel absorbent that contains hydrogen ions: paragraph 0008-0012).
Regarding claim 97, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein at least one of the one or more material layers (3/5) is immobilized to the analogous acid providing layer (2) without an adhesive (the one or material [3/5] comprising the supporting layer [3] is embedded into the acid providing layer without an adhesive: paragraph 0020-0021/0030-0031).
Claims 87 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (US 20160089473 A1) in view of Munro et al. (US 20160250373 A1, different interpretation) and in further view of Andrews (US 20190262185 A1).
Regarding claim 87, Wood et al. discloses a wound dressing (figure 1, a two component dressing system: paragraph 0008-0012) for treating a wound (the wound dressing [figure 1] is applied to wounds: paragraph 0007), comprising: a cover layer (the wound dressing [figure 1] can have a barrier layer, such as a polyurethane film or an adhesive coated polyurethane film on the surface facing away from the wound site; this barrier layer provides a bacterial barrier: paragraph 0054) configured to form a seal around the wound (the cover layer is capable of forming a seal around the wound); a nitrite providing layer comprising a nitrite salt (the wound dressing comprises a layer containing nitrite salt: paragraph 0008-0012/0019); and an acid providing layer (a hydrogel absorbent that contains hydrogen ions: paragraph 0008-0012) positioned below the cover layer (the acid providing layer is placed in direct contact with the skin and has a cover layer on the surface facing away from the wound site: paragraph 0007-0012), comprising acidic groups (the acid providing layer contains hydrogen ions: paragraph 0010)
However, Wood et al. fails to disclose wherein the acid providing layer comprises one or more immobilized material layers, at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound, the one or more material layers comprising a non-woven material, and wherein the acid providing layer further comprises one or more holes through the thickness of the acid providing layer.
Munro et al. teaches wherein an analogous acid providing layer (2 – figure 5, islands of hydrogel: paragraph 0103) comprises one or more immobilized material layers (1/5 – figure 5, a backing layer [1] and an absorbent layer [5]: paragraph 0020/0103), at least one material layer (4 – figure 5, a layer of adhesive: paragraph 0103) positioned on a surface of the analogous acid providing layer (figure 5, the at least one material layer [4] is on a surface of the acid providing layer: paragraph 0103) and configured to reduce adhesion of the acid providing layer (2) to the wound (the at least one material layer [4] is on the surface of the acid providing layer facing the wound site; since there is at least one material layer [4] between the acid providing layer [2] and the wound site, it reduces the adhesion of the acid providing layer [2] to the wound [see examiner further notes below]: paragraph 0053), the one or more material layers (1/5) comprising a non-woven material (the one or more material [1/5] comprising the backing layer [1] can be woven, nonwoven, or net: paragraph 0024).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the acid providing layer of Wood et al. to comprise one or more material layers, at least one material layer positioned on a surface of the acid providing layer, and the one or more material layers comprising a non-woven material as taught by Munro et al. in order to provide a wound dressing that has an improved acid providing layer in which the one or more material and the at least one material layer maintains structural integrity of the wound dressing during use (paragraph 0018-0019, Munro et al.).
However, Wood et al. in view of Munro et al. fails to disclose wherein the acid providing layer further comprises one or more holes through the thickness of the acid providing layer.
Andrews teaches wherein an analogous acid providing layer (101 – figure 2, a layer of hydrogel: paragraph 0118) further comprises one or more holes (102 – figure 2, apertures extending through the acid providing layer [101]: paragraph 0118) through the thickness of the analogous acid providing layer (101) (figure 2, the acid providing layer [101] has one or more holes [102] extending therethrough: paragraph 0118).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the acid providing layer of Woods et al. in view of Munro et al. with one or more holes through the thickness of the acid providing layer as taught by Andrews in order to provide a wound dressing that has an improved acid providing layer that enables a moist wound environment to be maintained for prolonged periods over a wide range of wound exudation rate (paragraph 0043, Andrews).
Regarding claim 94, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87. Munro et al. further teaches wherein the analogous acid providing layer (2) is encapsulated by the one or more material layers (1/5) (figure 5, the absorbent layer [5] and backing layer [1] encapsulates the acid providing layer [2]: paragraph 0043).
Claim 98 is rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (US 20160089473 A1) in view of Munro et al. (US 20160250373 A1) in view of Andrews (US 20190262185 A1) and in further view of Atteia (WO 2011121394 A1).
Regarding claim 98, Wood et al. in view of Munro et al. and in further view of Andrews discloses the invention as discussed in claim 87.
However, Wood et al. in view of Munro et al. and in further view of Andrews fails to disclose wherein the acid providing layer comprises a plurality of perforations.
Atteia teaches wherein an analogous acid providing layer (7 – figure 1, hydrogel layer sheet: page 19, lines 8-23) comprises a plurality of perforations (9 – figure 1, a plurality of perforations: page 19, lines 8-23).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the acid providing layer of Wood et al. in view of Munro et al. and in further view of Andrews with a plurality of perforations as taught by Atteia in order to provide a wound dressing that has an improved acid providing layer that keep moisture content at the wound bed at the desired level to prevent desiccation of the wound (page 9, lines 4-10).
Claims 99-101 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (US 20160089473 A1) in view of Waite (US 20200000642 A1) and in further view of Andrews (US 20190262185 A1).
Regarding claim 99, Wood et al. discloses a method for treating a wound comprising (figure 1, a two component dressing system: paragraph 0008-0012): applying a wound dressing to the wound (figure 1, a dressing system that is applied to the skin: paragraph 0007-0012), the wound dressing comprising: a cover layer configured to form a seal around the wound; a nitrite providing layer comprising a nitrite salt (the wound dressing a layer containing nitrite salt: paragraph 0008-0012/0019); and an acid providing layer comprising acidic groups (a hydrogel absorbent that contains hydrogen ions: paragraph 0008-0012), wherein the acid providing layer comprises one or more material layers immobilized therein (the acid providing layer can comprise a solid layer within it; it can be made of any suitable material: paragraph 0053).
However, Wood et al. fails to disclose a cover layer configured to form a seal around the wound; and an acid providing layer positioned below the cover layer, at least one material layer positioned on a surface of the acid providing layer and configured to reduce adhesion of the acid providing layer to the wound, and wherein the acid providing layer further comprises one or more holes through the thickness of the acid providing layer
Waite teaches a cover layer (102 – figure 6, a backing layer: paragraph 0023) configured to form a seal around the wound (the cover layer [102] adheres to the skin around the peri-wound: paragraph 0025); and an analogous acid providing layer (106 – figure 6, superabsorbent layer made of hydrogel or hydrogel composition: paragraph 0031) positioned below the cover layer (102) (figure 6, the acid providing layer [106] is below the cover layer [102]), at least one material layer (108 – figure 6, a second elastic foam layer that contacts the wound site: paragraph 0037) positioned on a surface of the analogous acid providing layer (figure 6, the at least one material layer [108] is positioned on a surface of the acid providing layer [106]) and configured to reduce adhesion of the acid providing layer (106) to the wound (figure 6, since the at least one material layer [108] is between the wound site and the acid providing layer [106], the at least one material layer [108] reduces the adhesion of the acid providing layer [106] to the wound).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the acid providing layer of Wood et al. with a cover layer and at least one material layer on the surface of the acid providing layer as taught by Waite in order to provide a wound dressing that has an improved acid providing layer to enhance breathability, increase total fluid handling capacity while promoting a moist wound environment, promote protection against microorganisms, and retain elasticity of the wound dressing (paragraph 0017/0024, Waite).
However, Wood et al. in view of Waite fails to disclose wherein the acid providing layer further comprises one or more holes through the thickness of the acid providing layer.
Andrews teaches wherein an analogous acid providing layer (101 – figure 2, a layer of hydrogel: paragraph 0118) further comprises one or more holes (102 – figure 2, apertures extending through the acid providing layer [101]: paragraph 0118) through the thickness of the analogous acid providing layer (101) (figure 2, the acid providing layer [101] has one or more holes [102] extending therethrough: paragraph 0118).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the acid providing layer of Woods et al. in view of Waite with one or more holes through the thickness of the acid providing layer as taught by Andrews in order to provide a wound dressing that has an improved acid providing layer that enables a moist wound environment to be maintained for prolonged periods over a wide range of wound exudation rate (paragraph 0043, Andrews).
Regarding claim 100, Wood et al. in view of Waite and in further view of Andrews discloses the method as discussed in claim 99. Wood et al. further discloses comprising generating nitric oxide (when the two-components [hydrogel layer and nitrite layer] are placed in contact, a chemical reaction takes place to produce nitric oxide: paragraph 0011-0012).
Regarding claim 101, Wood et al. in view of Waite and in further view of Andrews discloses the method as discussed in claim 99. Wood et al. further discloses comprising allowing nitrite ions of the nitrite salt to contact the acid providing layer (figure 1, the second component [hydrogel, acid providing layer] is placed on top of the first component [nitrite layer], which allows the nitrite salt to contact the acid providing layer: paragraph 0037/0056).
Conclusion
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
