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 .
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, 91-92, 97, 99, and 101 in the response filed on 1/30/2026 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 page 6, filed 1/30/2026, with respect to the objections of 91-92, 97, and 101 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant's arguments, see page 6, filed 1/30/2026, with respect to the rejection of claims 48-49, 52-53, and 57 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant's arguments, see page 7, filed 1/30/2026, with respect to the rejection of claim 48 under 35 U.S.C. 103 have been fully considered and are persuasive. However, a new motivation with the same arts (Wood et al. [US 20160089473 A1] in view of Allen et al. [US 20150216733 A1]) is provided below. Furthermore, Wood et al. in view of Allen et al. still reads on the claim limitations. 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). Allen et al. teaches an acquisition distribution layer (3440 – figure 34A, an acquisition distribution layer: paragraph 0189); and a masking element (3420 - figure 34A, a masking or obscuring layer: paragraph 0193-0195) above the acquisition distribution layer (3440) (figure 34A, the masking element [3420] is above the acquisition distribution layer [3440]), the masking element (3420) configured to at least partially prevent visualization of an analogous layer (3430 - figure 34A, an absorbent layer: paragraph 0190) there below (figure 34A, the masking element [3420] is configured to at least partially visually obscure fluid contained within the layer [3430]: paragraph 0195).
Applicant's arguments, see page 7, filed 1/30/2026, with respect to the rejection of claim 87 under 35 U.S.C. 103 have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection was made in view of Wood et al. (US 20160089473 A1) in view of Munro et al. (US 20160250373 A1) and in further view of Andrews (US 20190262185 A1) and Wood et al. (US 20160089473 A1) in view of Bishop et al. (US 20190133830 A1) and in further view of Andrews (US 20190262185 A1) to meet the newly added limitations of claim 87.
Applicant's arguments, see page 8, filed 1/30/2026, with respect to the rejection of claim 99 under 35 U.S.C. 103 have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection was made in view of Wood et al. (US 20160089473 A1) in view of Waite (US 20200000642 A1) and in further view of Andrews (US 20190262185 A1).
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).
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 there below.
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 - figure 34A, a masking or obscuring layer: paragraph 0193-0195) above the acquisition distribution layer (3440) (figure 34A, the masking element [3420] is above the acquisition distribution layer [3440]), the masking element configured to at least partially prevent visualization of a layer (3430 - figure 34A, an absorbent layer: paragraph 0190) there below (figure 34A, the masking element [3420] is configured to at least partially visually obscure fluid contained within the layer [3430]: paragraph 0195).
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 reduces the unsightly appearance of the wound dressing during absorption of wound exudate (paragraph 0189/0193, 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. Allen et al. further teaches wherein the masking element (3420) comprises one or more viewing windows (3422 - figure 34A, the masking element [3420] can comprise one or more viewing windows: paragraph 0194).
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 87-92 and 95-98 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 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), wherein the acid providing layer comprises one or more material layers immobilized therein (the acid providing layer can comprise a solid layer of any suitable material: paragraph 0053).
However, Wood et al. fails to disclose 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 an analogous one or more material layers (3 – figure 2, a supporting layer that can comprise of a scrim: paragraph 0020) comprising a non-woven material (the one or more material [3] can be woven, nonwoven, or net [mesh]: paragraph 0020).
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 modified one or more material layers of Wood et al. to comprise of a non-woven material as taught by Munro et al. in order to provide a wound dressing that has an improved acid providing layer to enhance the mechanical strength of the wound dressing (paragraph 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 analogous one or more material layers (3) comprise woven material (the one or more material layers [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 analogous one or more material layers (3) comprise a mesh (the one or more material layers [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 analogous one or more material layers (3) comprise polypropylene, polyethylene, or a combination thereof (the one or more material layers [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 – figure 2, islands of discrete hydrogel: paragraph 0099) comprises an analogous one material layer (3), wherein the one analogous material layer (3) 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] can be 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 – figure 2, islands of discrete hydrogel: paragraph 0099) comprises an analogous one material layer (3), wherein the one analogous material layer (3) 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] can be on a non-wound facing side [B]: paragraph 0020).
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 analogous one or more material layers (3) are embedded within the analogous acid providing layer (2 – figure 2, islands of discrete hydrogel: paragraph 0099) (figure 2, the one or more materials layers [3] can be embedded within the acid providing layer [2]: paragraph 0020-0021).
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. Wood et al. further discloses wherein at least one of the one or more material layers is immobilized to the acid providing layer without an adhesive (the material layer is in the middle of the acid providing layer [hydrogel]; it is sandwiched in between the two layers of the acid providing layer [hydrogel]; the acid providing layer [hydrogel] is an adhesive itself, no other additional adhesives were used to immobilized the material layer: paragraph 0053/0056).
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. Munro et al. further teaches wherein an analogous acid providing layer (2 – figure 2, islands of discrete hydrogel: paragraph 0099) comprises a plurality of perforations (figure 1/2, the acid providing layer [2] are islands with spacing between them: paragraph 0013).
Claims 87 and 93-94 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (US 20160089473 A1) in view of Bishop et al. (US 20190133830 A1) 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 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), (the acid providing layer can comprise a solid layer of any suitable material: paragraph 0053).
However, Wood et al. fails to disclose wherein the acid providing layer comprises one or more material layers immobilized therein, 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.
Bishop et al. teaches an analogous acid providing layer (130a-130h – figure 5B, a plurality of absorbent layers: paragraph 0069) positioned below an analogous cover layer (82 – figure 5B, a backing layer: paragraph 0059) (figure 5B, the acid providing layers [130a-130h] are below the cover layer [82]), comprising acidic groups (the acid providing layer [130a-130h] can be made from sodium carboxymethylcellulose fibers or carboxymethylated cellulose fibers, which contain acidic groups: paragraph 0069), wherein an analogous acid providing layer (130a-130h) comprises one or more material layers (119/121 – figure 5B, a nonwoven spun lace layer [119] and a thermoplastic spin lace layer [121]: paragraph 0063) immobilized therein (figure 3B/5B, the acid providing layer [130a-130h] is immobilized in an envelope [120 – figure 3B/5B] via the one or more material layers [119/121]; the one or more material layers [119/121] are heat bonded at its perimeter to create the envelope [120] that houses the acid providing layers [130a-130h]: paragraph 0063) the one or more material layers (119/121) comprising a non-woven material (the one or more materials [119/121] comprises a nonwoven spun lace layer: paragraph 0063).
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 one or more material layers immobilized therein and wherein the one or more material layers comprises a non-woven material as taught by Bishop et al. in order to provide a wound dressing that has an improved acid providing layer to enhance the mechanical strength of the wound dressing and assist in adhering the layers together (paragraph 0082, Bishop et al.).
However, Wood et al. in view of Bishop 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 Bishop 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 93, Wood et al. in view of Bishop et al. and in further view of Andrews discloses the invention as discussed in claim 87. Bishop et al. further teaches wherein the analogous acid providing layer (130a-130h) is sandwiched between the one or more material layers (119/121) (figure 3B, the one or more materials [119/121] are sandwiching the acid providing layer [130a-130h]).
Regarding claim 94, Wood et al. in view of Bishop et al. and in further view of Andrews discloses the invention as discussed in claim 87. Bishop et al. further teaches wherein the acid providing layer (130a-130h) is encapsulated by the one or more material layers (119/121) (figure 3B, the one or more material layers [119/121] are encapsulating the acid providing layer [130a-130h]).
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, 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]).
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 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, and promote protection against microorganisms (paragraph 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
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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