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.
Election/Restrictions
Claims 48-49, 52, 53, 57, and 99-101 are provisionally withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/21/2025.
Examiner agrees with Applicant and withdraws the previous restriction requirement. Claims 48-49, 52-53, 57, and 87-101 are examined below. Furthermore, please correct claim status identifier for clarity purposes.
Claim Objections
Claim 91 objected to because of the following informalities: “wherein the material layer” should be “wherein the one material layer” in line 2. Appropriate correction is required.
Claim 92 objected to because of the following informalities: “wherein the material layer” should be “wherein the one material layer” in line 2. Appropriate correction is required.
Claim 97 objected to because of the following informalities: “wherein the material layers” should be “wherein the one or more material layers” in line 1. Appropriate correction is required.
Claim 101 objected to because of the following informalities: “The wound dressing of claim 99, further comprising allowing nitrite ions of the nitrite salt to contact the acid providing layer” should read as “The method of claim 99, further comprising allowing nitrite ions of the nitrite salt to contact the acid providing layer”. 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 48-49, 52-53, and 57 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.
Claim 48 recites the limitation "the layer" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 49, 52-53, and 57 are also rejected to its dependency on claim 48.
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, 52-53, 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 a masking element configured to at least partially prevent visualization of the layer there below.
Allen et al. teaches a masking element (3420 - figure 34A, a masking or obscuring layer: paragraph 0193-0195) 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).
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 a masking element as taught by Allen et al. in order to provide an improved wound dressing to allow clinicians to visually assess and monitor the extent of spread of exudate across the wound dressing (paragraph 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. 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 53 Wood et al. in view of Allen et al. discloses the invention as discussed in claim 48. Allen et al. further teaches an acquisition distribution layer (3440 - figure 3A, an acquisition distribution layer: paragraph 0211).
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).
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.
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.).
Regarding claim 88, Wood et al. in view of Munro et al. 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. 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. 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. 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 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. 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 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. 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. 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. discloses the invention as discussed in claim 87. Wood et al. further discloses wherein the material layers are 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. 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).
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.
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.).
Regarding claim 93, Wood et al. in view of Bishop et al. 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. 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).
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.
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).
Regarding claim 100, Wood et al. in view of Waite 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 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
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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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786