DETAILED ACTION
In Applicant’s Response filed 8/7/25, Applicant amended claims 1 and 17-20. Claims 4 and 11 have been cancelled. Currently, claims 1-3, 5-10 and 12-20 are pending.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/7/25 was filed after the mailing date of the non-final rejection on 5/7/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-3, 5, 7 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Curro et al (US 2004/0265534).
With respect to claim 2, Curro discloses a component for a wound dressing (web 1 which can be used for medical treatment such as by being a base cloth for an adhesive plaster and thus is interpreted as being capable of use as a wound dressing; para [0093]) comprising an elastomeric planar backing sheet (the layers forming web 1 are planar – para [0025]; web 20 can comprise elastic or elastomeric fibers – para [0041]) and an absorbent yarn (the fibers of web 20 or 21 can comprise a super absorbent material – para [0029]) wherein the yarn extends through the planar backing sheet from the first side of the sheet to form a plurality of tufts on the second side of the planar backing sheet (tufts 6 extend from web 20 through web 21 and outwardly from surface 13 of web 21 – para [0027]).
With respect to claim 3, Curro discloses the component as claimed (see rejection of claim 2) and also discloses that the absorbent yarn comprises at least 50% absorbent material (The fibers can be monocomponent - para [0029]; monocomponent fibers are interpreted as comprising 100% absorbent material since they comprise only one polymer – para [0033]).
With respect to claim 5, Curro discloses the component as claimed (see rejection of claim 2) and also discloses that the absorbent material is a hydrophilic yarn (para [0090]).
With respect to claim 7, Curro discloses the component as claimed (see rejection of claim 2) and also discloses that the tufts are fixed to the planar backing sheet (para [0025]).
With respect to claim 13, Curro discloses the component as claimed (see rejection of claim 2) and also disclose that the component is a wound dressing (web 1 which can be used for medical treatment such as by being a base cloth for an adhesive plaster and thus is interpreted as being capable of use as a wound dressing; para [0093]).
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.
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.
Claims 1, 8-10, 14-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans et al (WO 2018037075 A1) in view of Lange et al (EP 2777662 A1) and further in view of Smith et al (US 2013/0298519).
With respect to claim 1, Gowans discloses a negative pressure wound dressing (dressing 100 in fig 2B; used for negative pressure wound therapy as discussed i.e. in para [0025;0029]) comprising a component (absorbent layer 221) comprising a superabsorbent (para [0040]) configured to retain structural integrity and maintain an airpath for negative pressure applied at between about -20 mmHg to -200 mmHg (para [0027]; it is inherent that the absorbent layer 221 maintains structural integrity and maintains an airpath during application of NPWT otherwise treatment at the levels disclosed in para [0027] would not be accomplished; see also para [0040]); a cover layer (cover layer 220) positioned over the absorbent component (as shown in fig 2B): and a wound contact layer (wound contact layer 222) positioned under the absorbent component (as shown in fig 2B).
Gowans does not, however, disclose that said component comprises a planar backing sheet and a yarn, the yarn extending through the planar backing sheet from a first side of the planar backing sheet to form a plurality of tufts on a second side of the planar backing sheet.
Lange, however, teaches a wound dressing (nonwoven fabric for cleaning
wounds — abstract; a wound cleansing product is interpreted as being capable of use as a
wound dressing) comprising a component (nonwoven fabric) wherein said component
comprises a planar backing sheet and a yarn wherein the yarn extends through the planar
backing sheet from the first side of the planar backing sheet to form a plurality of tufts on the
second side of the planar backing sheet (the nonwoven fabric can comprise a first/single layer
where fibers protrude in loops from the first layer — para [0015-0017]). Lange further teaches that the loops formed in the fabric retain incrustations, dead cells or secretions in the fabric to enable wound healing and remove biofilms and bacteria in a way that reduces microbial load (para [0010]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have replaced the absorbent layer of Gowans with the nonwoven fabric component of Lange in order to improve wound healing by reducing microbial load and allowing for incrustations, dead cells or secretions to be retained in the fabric.
Lange teaches that core-sheath fibers can be used but does not explicitly teach that the yarns comprise an elastic core fiber and an absorbent secondary fiber disposed exteriorly around the core fiber.
Smith, however, teaches that "core-spun yarn" is known in the art to include yarn made by twisting fibers around a filament wherein the core yarn is an elastic spandex yarn to impart stretch-recovery character and the covering fiber is cotton to obtain desirable touch aesthetic (para [0041]; cotton inherently is absorbent). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used an elastic core fiber and an absorbent secondary fiber disposed exteriorly around the core fiber as the yarn in the device of Gowans in view of Lange in order to impart stretch recovery character while also providing desirable touch aesthetic for the user. Furthermore, one of ordinary skill in the art would have been motivated to use such a yarn in the device of Gowans in view of Lange because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 8, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) and Lange also discloses that the yarn is a monofilament yarn (para [0025; 0029; 0066]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a monofilament yarn, as taught by Lange, as the yarn in the component of the dressing of Gowans in view of Lange and further in view of Smith since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claims 9-10, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) and Lange also discloses a further backing sheet located on a top surface of the tufts (second layer that serves as a cover layer – para [0017-0018]) wherein the further backing sheet is fixed to the top surface of the tufts (the second layer comprises second fibers that are at least partially connected to the first layer – para [0017]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have provided a further backing sheet located on a top surface of the tufts wherein the further backing sheet is fixed to the top surface of the tufts, as taught by Lange, in the component of the dressing of Gowans in view of Lange and further in view of Smith, in order to stabilize the planar backing sheet (Lange para [0018] describes how the second layer that serves as a cover layer over the first layer which includes loops stabilizes the first layer).
With respect to claim 14, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) and Gowans also discloses a method of treating a wound comprising placing the wound dressing over a wound (para [0029]).
With respect to claim 15, Gowans in view of Lange and further in view of Smith discloses the method substantially as claimed (see rejection of claim 14) and Gowans also discloses that the method of treating a wound is a conventional wound therapy treatment (the method of treating a wound using NPWT described in para [0025] is interpreted as being part of conventional wound therapy treatment).
With respect to claim 16, Gowans in view of Lange and further in view of Smith discloses the wound dressing and method of treatment as claimed (see rejection of claim 14) and Gowans also discloses that the treatment is negative pressure wound therapy treatment (para [0002;0025]).
With respect to claim 17, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) and Gowans also discloses a transmission layer positioned over the absorbent component and under the cover layer (para [0044] - another transmission layer may be provided over the absorbent layer 221 and beneath the backing layer 220).
With respect to claim 18, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 17) and Gowans also discloses that the transmission layer is nonabsorbent (transmission layer 226 allows transmission of fluid including liquid and gas away from a wound site into upper layers of the wound dressing – para [0034] and is formed of polyester – para [0035]; polyester is hydrophobic and thus is nonabsorbent).
With respect to claim 20, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) and Gowans also discloses that the negative pressure is applied at between about -40 mmHg to -150 mmHg (para [0027]).
Claims 1, 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gowans et al (WO 2018037075 A1) in view of Curro et al (US 2004/0265534) and further in view of Smith et al (US 2013/0298519).
With respect to claim 1, Gowans discloses a negative pressure wound dressing (dressing 100 in fig 2B; used for negative pressure wound therapy as discussed i.e. in para [0025;0029]) comprising a component (absorbent layer 221) comprising a superabsorbent (para [0040]) configured to retain structural integrity and maintain an airpath for negative pressure applied at between about -20 mmHg to -200 mmHg (para [0027]; it is inherent that the absorbent layer 221 maintains structural integrity and maintains an airpath during application of NPWT otherwise treatment at the levels disclosed in para [0027] would not be accomplished; see also para [0040]); a cover layer (cover layer 220) positioned over the absorbent component (as shown in fig 2B): and a wound contact layer (wound contact layer 222) positioned under the absorbent component (as shown in fig 2B).
Gowans does not, however, disclose that said component comprises a planar backing sheet and a yarn, the yarn extending through the planar backing sheet from a first side of the planar backing sheet to form a plurality of tufts on a second side of the planar backing sheet.
Curro, however, teaches a wound dressing (the web can be used for medical treatment such as by being a base cloth for an adhesive plaster and thus is interpreted as being capable of use as a wound dressing; para [0093]) comprising a component (web 1; para [0025]) wherein said component comprises a planar backing sheet (the layers forming web 1 are planar — para [0025]) and a yarn (nonwoven webs comprise a structure of individual threads — para [0028]; yarn is a spun thread) wherein the yarn extends through the planar backing sheet from the first side of the planar backing sheet to form a plurality of tufts on the second side of the planar backing sheet (tufts 6 extend from web 20 through web 21 and outwardly from surface 13 of web 21 — para [0027]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have replaced the absorbent layer of Gowans with the web component of Curro in order to provide increased bulk properties (Curro para [0002]).
Curro does not, however, teach that the yarns comprise an elastic core fiber and an absorbent secondary fiber disposed exteriorly around the core fiber.
Smith, however, teaches that "core-spun yarn" is known in the art to include yarn made by twisting fibers around a filament wherein the core yarn is an elastic spandex yarn to impart stretch-recovery character and the covering fiber is cotton to obtain desirable touch aesthetic (para [0041]; cotton inherently is absorbent). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used an elastic core fiber and an absorbent secondary fiber disposed exteriorly around the core fiber as the yarn in the device of Gowans in view of Curro in order to impart stretch recovery character while also providing desirable touch aesthetic for the user. Furthermore, one of ordinary skill in the art would have been motivated to use such a yarn in the device of Gowans in view of Curro because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
With respect to claim 19, Gowans in view of Curro and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) and Curro further teaches that the planar backing sheet comprises a film (web 1 comprises at least two layers which are generally planar, two-dimensional precursor webs wherein either precursor web can be a film, a nonwoven, or a woven web – para [0025]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a film as taught by Curro for the planar backing sheet on the dressing of Gowans in view of Curro and further in view of Smith since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Curro et al (US 2004/0265534).
With respect to claim 6, Curro discloses the component as claimed (see rejection of claim 2) but does not explicitly disclose that the tufts are formed in a zig-zag pattern. Curro does, however, teach that the “tufts 6 can be arranged in patterns such as lines or filled shapes to create portions of a laminate web having greater texture, softness, bulk, absorbency or visual design appeal” wherein the tufts can be arranged in a pattern of a line or lines, can have the appearance of stitching, and/or can be arranged to form specific shapes, designs, words or logos (para [0038]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have arranged the tufts in a zig-zag pattern mimicking zig-zag stitching in order to create portions of a laminate web having greater texture, softness, bulk, absorbency or visual design appeal.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans et al (WO 2018037075 A1) in view of Curro et al (US 2004/0265534).
With respect to claim 12, Gowans discloses a negative pressure apparatus (dressing 100 in fig 2B; used for negative pressure wound therapy as discussed i.e. in para [0025;0029]) comprising a wound contact layer (wound contact layer 222); a transmission layer (transmission layer 226), a component (absorbent layer 221); a cover layer (cover layer 220) and an orifice (orifice 227) to allow a negative pressure to be applied to the dressing (para [0042]).
Gowans does not, however, disclose that the component comprises an elastomeric planar backing sheet and an absorbent yarn wherein the yarn extends through the planar backing sheet from a first side of the sheet to form a plurality of tufts on a second side of the planar backing sheet (as recited in claim 2).
Curro, however, teaches a component for a wound dressing (web 1 which can be used for medical treatment such as by being a base cloth for an adhesive plaster and thus is interpreted as being capable of use as a wound dressing; para [0093]) comprising an elastomeric planar backing sheet (the layers forming web 1 are planar – para [0025]; web 20 can comprise elastic or elastomeric fibers – para [0041]) and an absorbent yarn (the fibers of web 20 or 21 can comprise a super absorbent material – para [0029]) wherein the yarn extends through the planar backing sheet from the first side of the sheet to form a plurality of tufts on the second side of the planar backing sheet (tufts 6 extend from web 20 through web 21 and outwardly from surface 13 of web 21 – para [0027]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have replaced the absorbent layer of Gowans with the web component of Curro in order to provide increased bulk properties (Curro para [0002]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gowans et al (WO 2018037075 A1) in view of Lange et al (EP 2777662 A1) and Smith et al (US 2013/0298519) and further in view of Curro et al (US 2004/0265534).
With respect to claim 19, Gowans in view of Lange and further in view of Smith discloses the dressing substantially as claimed (see rejection of claim 1) but does not disclose that the planar backing sheet comprises a film.
Curro, however, teaches a wound dressing (the web can be used for medical treatment such as by being a base cloth for an adhesive plaster and thus is interpreted as being capable of use as a wound dressing; para [0093]) comprising a component (web 1; para [0025]) wherein said component comprises a planar backing sheet (the layers forming web 1 are planar — para [0025]) that comprises a film (web 1 comprises at least two layers which are generally planar, two-dimensional precursor webs wherein either precursor web can be a film, a nonwoven, or a woven web – para [0025]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a film as taught by Curro for the planar backing sheet on the dressing of Gowans in view of Lange and further in view of Smith since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 8/7/25 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments to the claims have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 102 and 35 USC 103, Applicant’s arguments on pages 4-6 of the Response regarding the Curro and Lange references have been fully considered but are not persuasive. Specifically, the Office has noted Applicant’s arguments that the Curro and Lange reference do not describe any beneficial use of their tufted layer for the application of negative pressure wound therapy and, more specifically, provide no description at all of wound dressings or negative pressure wound therapy, instead reciting a laundry list of potential applications for the technology. Applicant further provides a listing of the uses disclosed in Curro and Lange for the materials disclosed in these references and argues that one of skill in the art would have no motivation to combine such references given the disparity of the inventions. The Office is not persuaded by these arguments, however, because the prior art device of Curro includes the same structural features as the claimed dressing and would be capable of being used in negative pressure wound therapy. Furthermore, the Lange reference teaches a nonwoven fabric for cleaning wounds which is interpreted as being capable of use as a wound dressing. Thus, the Office disagrees that there would be no motivation to combine these references due to disparity between these inventions. For at least these reasons, the Office maintains that the prior art of record reads on the claims. Furthermore, Applicant’s arguments on page 6 relating to claim 1 have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Citation of Pertinent Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2019/0125590.
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 CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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