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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
Response to Arguments
Applicant’s amendment filed 12/02/2025 is accepted and entered.
Applicant’s arguments regarding the priority of the case is persuasive.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Cotton is now cited to disclose the limitations of independent Claim 1, as set forth below.
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) 1, 2, 11, 12, 16, 17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cotton (US 2016/0067107).
Regarding Claim 1, Cotton discloses a wound dressing (1, Fig. 2) comprising:
a wound contact layer (gelling material 14, Fig. 2; ¶ [0062]);
a backing layer (11, Fig. 2);
an intermediate layer (superabsorbent material 13, Fig. 2) located between the backing layer (11, Fig. 2) and wound contact layer (14, Fig. 2) and comprising a first surface facing the wound contact layer (14, Fig. 2) and a second surface facing the backing layer (11, Fig. 2), wherein the first surface of the intermediate layer (13, Fig. 2) is bonded directly or indirectly to the wound contact layer (14, Fig. 2; ¶ [0062]; when the gelling material absorbs liquid and gels, the material will bond at least somewhat to the superabsorbent layer) and the second surface is unbonded to the backing layer (11, Fig. 2); and,
a wound-site adhesive layer (silicone gel layer 16, Fig. 2) provided on a peripheral region of the backing layer (11, Fig. 2) for adhering the backing layer (11, Fig. 2) to a wound site (¶ [0048-0052, 0062]);
wherein the intermediate layer (13, Fig. 2) is a superabsorbent layer (¶ [0061-0062]), and
wherein the wound contact layer (14, Fig. 2) includes gel forming fibers (¶ [0061, 0065]).
Regarding Claim 2, Cotton discloses the intermediate layer (13, Fig. 2) is adhered directly or indirectly to the wound contact layer (14, Fig. 2; ¶ [0062]; when the gelling material absorbs liquid and gels, the material will adhere at least somewhat to the superabsorbent layer).
Regarding Claim 11, Cotton discloses the wound-site adhesive layer (16, Fig. 2) comprises a border region of adhesive which surrounds a central region in which the wound contact layer (14, Fig. 2) is located (Fig. 2).
Regarding Claim 12, Cotton discloses the border region (formed by adhesive 16, Fig. 2) partially covers the wound contact layer (14, Fig. 2).
Regarding Claim 16, Cotton discloses the wound-site adhesive layer (16, Fig. 3) extends continuously across the wound contact layer (14, Fig. 3; ¶ [0071]).
Regarding Claim 17, Cotton discloses the wound-site adhesive layer (16, Fig. 2) is perforated (17, Fig. 2; ¶ [0071]).
Regarding Claim 19, Cotton discloses the wound contact layer (14, Fig. 2) is unfenestrated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 5, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067107) in view of Hoggarth et al (US 2018/0125722).
Regarding Claim 3, Cotton is silent regarding an adhesive to provide the adherence of the intermediate layer to the wound contact layer.
Hoggarth teaches a wound dressing, thus being in the same field of endeavor, with an adhesive (3, Fig. 1) that provides the adherence of the intermediate layer (absorbent material 4, Fig. 1) to the wound contact layer (wicking material 2, Fig. 1; ¶ [0095]). This ensures the dressing stays together and prevents delamination during use.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wound dressing of Cotton to include an adhesive to provide the adherence of the intermediate layer to the wound contact layer, as taught by Hoggarth. This ensures the dressing stays together and prevents delamination during use.
Regarding Claim 5, Cotton is silent whether the intermediate layer comprises polyacrylate fibers.
Hoggarth teaches a wound dressing where the superabsorbent layer comprises polyacrylate fibers (¶ [0014, 0107]).
Therefore, it would have been obvious to substitute the material of the intermediate superabsorbent layer of Cotton for the polyacrylate fibers, as taught by Hoggarth (¶ [0014, 0107]). Hoggarth shows that polyacrylate fibers are suitable for use as the superabsorbent material of a wound dressing, and it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding Claim 6, Cotton is silent whether the intermediate layer has an outer profile and the wound contact layer has a corresponding outer profile which is in register with the outer profile of the intermediate layer.
Hoggarth teaches a wound dressing where the intermediate layer (4, Figs. 3 and 4) has an outer profile and the wound contact layer (2, Figs. 3 and 4) has a corresponding outer profile which is in register with the outer profile of the intermediate layer (4, Figs. 3 and 4).
Therefore, it would have been obvious to modify the intermediate layer and wound contact layer of Cotton to have outer profiles which are in register with one another, as taught by Hoggarth (Figs. 3 and 4). Hoggarth shows that this structure of wound dressings is well known in the art, and therefore one of ordinary skill in the art would have found it obvious to modify the structure of Cotton as such.
Claim(s) 7-10 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067107) in view of Hoggarth et al (US 2018/0125722) further in view of Locke et al (US 2020/0121509).
Regarding Claims 7-10, Cotton/Hoggarth is silent regarding a foam layer located between the wound contact layer and backing layer, wherein the foam layer has a foam layer outer profile which corresponds with and is in register with an outer profile of the intermediate layer, wherein the foam layer is located between the wound contact layer and the first surface of the intermediate layer, wherein the foam layer is adhered to the wound contact layer.
Locke teaches a wound dressing, thus being in the same field of endeavor, with a foam layer (210, Fig. 2; ¶ [0078]) located between the wound contact layer (215, Fig. 2; ¶ [0085]) and backing layer (125, Fig. 2), wherein the foam layer (210, Fig. 2) has a foam layer outer profile which corresponds with and is in register with an outer profile of the intermediate layer (205, Fig. 2; ¶ [0072-0073] indicates layer 205 serves to collect wound exudate and therefore can act as an absorbent layer; ¶ [0110] indicates 205, 210, and 215 can all be coextensive and congruent); wherein the foam layer (210, Fig. 2) is located between the wound contact layer (215, Fig. 2) and the first surface of the intermediate layer (205, Fig. 2), and wherein the foam layer (210, Fig. 2) is adhered to the wound contact layer (215, Fig. 2; ¶ [0081]). The intermediate foam layer provides support for the third layer to improve the integrity of the dressing (¶ [0078]).
Therefore, it would have been obvious to modify the dressing of Cotton/Hoggarth to include a foam layer located between the wound contact layer and the first surface of the intermediate layer, where the foam layer has a foam layer outer profile which corresponds with and is in register with an outer profile of the intermediate layer, and wherein the foam layer is adhered to the wound contact layer, as taught by Locke. The foam layer provides support for the wound contact layer, improving the structural integrity of the dressing (as motivated by Locke ¶ [0078]).
Regarding Claims 13-15, Cotton further discloses the wound-site adhesive layer (16, Fig. 2) comprises an inner edge defining a central window (as seen in Fig. 2) through which the wound contact layer (14, Fig. 2) is exposed; wherein the wound contact layer (14, Fig. 2) comprises an outer edge and overlaps the adhesive layer (16, Fig. 2) around the periphery of the wound contact layer (14, Fig. 2) so as to be adhered thereto (as seen in Fig. 2).
Cotton/Hoggarth is silent whether the width of the overlap between the inner edge of the adhesive layer and the outer edge of the wound contact layer varies around the periphery of the wound contact layer, wherein the overlap comprises one or more corner region and one or more edge region of the wound contact layer and adhesive layer, wherein the width of the overlap in the corner regions is greater than the overlap in an adjacent edge region, wherein the one or more corner region comprises an inner edge having a first radius of curvature, and the outer edge comprises a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature.
Locke teaches a wound dressing, thus being in the same field of endeavor, with an adhesive layer (905, Fig. 9) comprising an inner edge (treatment aperture 915, Figs. 9 and 11) and a wound contact layer (215, Fig. 9) with an outer edge (1115, Fig. 11; ¶ [0110]); wherein the width of the overlap (overlay margin 1120, Fig. 11) between the inner edge (915, Fig. 11) of the adhesive layer and the outer edge (1115, Fig. 11) of the wound contact layer varies around the periphery of the wound contact layer (215, Fig. 9; ¶ [0096] indicates layer 215 can be rectangular rather than stadium shaped and ¶ [0111] indicates layer 215 can be larger than the treatment aperture 915, and as such the width of the overlap 1120 will be greater at the corners since the shape of 1115 would be a rectangle rather than an oval shape like the aperture 915), wherein the overlap comprises one or more corner region and one or more edge region of the contact layer (215, Fig. 9) and adhesive layer (905, Fig. 9), wherein the width of the overlap (1120, Fig. 11) in the corner regions is greater than the overlap in an adjacent edge region (215, Fig. 9; ¶ [0096] indicates layer 215 can be rectangular rather than stadium shaped and ¶ [0111] indicates layer 215 can be larger than the treatment aperture 915, and as such the width of the overlap 1120 will be greater at the corners since the shape of 1115 would be a rectangle rather than an oval shape like the aperture 915; this can be visualized by interpreting the rectangular outline of dressing 110 in Fig. 11 as the outline of 1115 and comparing the width from 915 to 110 at the corners compared to the edges), wherein the one or more corner region comprises an inner edge having a first radius of curvature (radius of curvature of treatment aperture 915, Fig. 11), and the outer edge comprises a second radius of curvature (radius of curvature of corner of rectangular layer 1115 which would be slightly rounded as seen in Fig. 11), wherein the first radius of curvature is greater than the second radius of curvature (the curve of the rectangular layers corner is much sharper and as such has a smaller radius of curvature than the treatment aperture 915, Fig. 11). Using rectangular foam layers increases the area of the layers compared to oval shaped layers, therefore increasing the absorbent capacity of the dressing.
Therefore, it would have been obvious to modify the dressing of Cotton/Hoggarth to have the width of the overlap between the inner edge of the adhesive layer and the outer edge of the wound contact layer vary around the periphery of the wound contact layer, wherein the overlap comprises one or more corner region and one or more edge region of the wound contact layer and adhesive layer, wherein the width of the overlap in the corner regions is greater than the overlap in an adjacent edge region, wherein the one or more corner region comprises an inner edge having a first radius of curvature, and the outer edge comprises a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature, as taught by Locke. Using rectangular foam layers increases the area of the layers compared to oval shaped layers, therefore increasing the absorbent capacity of the dressing, which would be beneficial to reduce dressing changes and potential discomfort to the patient.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067107).
Regarding Claim 18, Cotton discloses the perforations are 2-10mm in diameter (¶ [0052]).
However, Cotton does not explicitly disclose the perforations are between 1.6 mm and 2.5mm in diameter.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of the perforations of Cotton to be from 2-10mm in diameter to 1.6-2.5mm in diameter as applicant appears to have placed no criticality on the claimed range (see ¶ [0011] of the published specification indicating the diameter “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781