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 .
Response to Arguments
Applicant’s amendment filed 05/29/2026 is accepted and entered.
Applicant's arguments filed 05/29/2026 have been fully considered but they are not persuasive.
Applicant alleges that one of ordinary skill in the art would not be motivated to look to the field of negative pressure wound dressings to improve upon a wound dressing not for use with negative pressure. Applicant alleges that the backing layer of Locke is not continuous and thus does not read on the claim language. However, Locke is relied upon solely to incorporate the additional foam layer into the dressing of Cotton. Locke’s backing layer is not added or used to modify anything in the dressing of Cotton. Additionally, one of ordinary skill in the art would be motivated to look to negative pressure wound dressings to find improvements to use in non-negative pressure wound dressings as both negative and non-negative pressure wound dressings seek to control the flow of exudate from a wound to allow the wound to heal quickly and properly.
Applicant did not specifically argue the dependent claims.
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 9 and 10 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.
Regarding Claim 9, it is unclear how the foam layer can be located between the wound contact layer and the first surface of the intermediate layer since the foam layer forms a portion of the intermediate layer. For the purpose of compact prosecution, this limitation is interpreted as the foam layer is located between the wound contact layer and the superabsorbent layer. Claim 10 is also rejected based on its dependency on Claim 9.
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.
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) 1-3 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067107) in view of Locke et al (US 2020/0121509).
Regarding Claims 1 and 8-10, Cotton discloses a wound dressing (1, Fig. 2) comprising:
a wound contact layer (gelling material 14, Fig. 2; ¶ [0062]);
a continuous backing layer (11, Fig. 2) provided as an outer layer which defines an external surface of the dressing (1, Fig. 2; ¶ [0044-0048]);
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]).
Cotton is silent whether the intermediate layer comprises 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 superabsorbent 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 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 superabsorbent of Cotton, 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 2 and 3, the combination of Cotton/Locke discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Cotton/Locke further discloses the intermediate layer is adhered directly or indirectly to the wound contact layer, further comprising an adhesive to provide the adherence of the intermediate layer to the wound contact layer (Locke ¶ [0081] indicates that the foam layer 210 can be adhered to the wound contact layer 215 with an adhesive; and therefore the intermediate layer of Cotton/Locke will be adhered to the wound contact layer).
Regarding Claim 11, Cotton further 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 further discloses the border region (formed by adhesive 16, Fig. 2) partially covers the wound contact layer (14, Fig. 2).
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 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 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.
Regarding Claim 16, Cotton further discloses the wound-site adhesive layer (16, Fig. 3) extends continuously across the wound contact layer (14, Fig. 3; ¶ [0071]).
Regarding Claim 17, Cotton further discloses the wound-site adhesive layer (16, Fig. 2) is perforated (17, Fig. 2; ¶ [0071]).
Regarding Claim 18, Cotton further discloses the perforations are 2-10mm in diameter (¶ [0052]).
However, Cotton/Locke 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/Locke 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).
Regarding Claim 19, Cotton further discloses the wound contact layer (14, Fig. 2) is unfenestrated.
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067107) in view of Locke et al (US 2020/0121509) further in view of Hoggarth et al (US 2018/0125722).
Regarding Claim 5, Cotton/Locke 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/Locke 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, the combination of Cotton/Locke/Hoggarth discloses the claimed invention substantially as claimed as set forth above for Claim 5.
The combination of Cotton/Locke/Hoggarth further discloses the intermediate layer (Locke 205 and 210, Fig. 2) has an outer profile and the wound contact layer (Locke 215, Fig. 2) has a corresponding outer profile which is in register with the outer profile of the intermediate layer (Locke 205 and 210, Fig. 2; ¶ [0110] indicates 205, 210, and 215 can all be coextensive and congruent).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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