DETAILED ACTION
In Applicant’s Response filed 1/2/26, Applicant has amended claim 1 and amended the abstract. Currently, claims 1-20 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 .
Claim Objections
Claim 1 is objected to as failing to comply with 37 CFR 1.121 because the claim fails to include markings to identify changes which have been made to the claim. Specifically, claim 1 as amended includes a new limitation of "fluid-absorption" in line 4 which has been added but is not underlined. Under MPEP §714(II)(C)(B), “claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter) with 2 exceptions: (1) for deletion of five or fewer consecutive characters, double brackets may be used (e.g., [[eroor]]); (2) if strike-through cannot be easily perceived (e.g., deletion of number “4” or certain punctuation marks), double brackets must be used (e.g., [[4]])”. Therefore, currently amended claim 1 does not comply with 37 CFR 1.121. Revision is necessary (i.e. proper strikethrough and/or underlining of deleted/added terms) in order to provide clarity of the record. Additionally, the objection to claim 1 provided below has been maintained since although Applicant attempted to correct this deficiency, the amendment is not properly presented.
Claim 1 is objected to because of the following informalities: in line 4: “the absorbent layer” should be “the fluid-absorption layer”. Appropriate correction is required.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Adie et al (US 9061095) in view of Roberts (US 6124520) and further in view of Holm (US 2011/0112457).
With respect to claims 1-2, Adie discloses a wound dressing (wound dressing 100; fig 1A; col 7 lines 66-67) comprising:
a breathable film (film cover layer 140; col 12 lines 33-39; the film is gas impermeable but moisture vapor permeable and therefore is interpreted as being “breathable” because water vapor is permitted to escape through the material);
a fluid-absorption layer (layer 110 of absorbent material); and
a fluid-wicking layer for directing fluid towards the absorbent layer (layer 105 – allows transmission of fluid from wound site into upper layers of the dressing such as absorbent layer 110 – col 9 lines 44-60; col 10 lines 39-44);
wherein the fluid-absorption layer (110) is positioned between the breathable film (140) and the fluid wicking layer (105) (as shown in fig 1A, layer 110 is provided between layers 140 and 105).
Adie does not, however, disclose that the wound dressing comprises a transparent part that enables observation of the wound wherein the wound dressing comprises a transparent breathable film.
Roberts, however, teaches a wound dressing (window dressing 10) comprising:
A transparent breathable film (semi-permeable film layer 20; col 2 lines 44-45);
A fluid absorption layer (absorbent fiber layer 26); and
A fluid-wicking layer (porous film layer 30).
Roberts further teaches that the invention relates to “transparent dressings” for protecting wounds that provide continual visual access to the wound (col 1 lines 4-8). Thus, Roberts is interpreted as teaching that at least part of the dressing is transparent in order to permit observation of a wound and that, more specifically, the transparent part is a breathable film. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Adie so that the dressing comprises a transparent part that enables observation of the wound and, more specifically, comprises a transparent breathable film as taught by Roberts in order to permit viewing through the dressing for wound inspection.
Adie in view of Roberts does not, however, disclose that the breathable film, the fluid-absorption layer, and the fluid-wicking layer are arranged in a layered concentric configuration such that they are annular with respect to one another.
Holm, however, teaches a similar wound dressing (115; fig 10) wherein the breathable film (backing 118 which is a film as described in para [0106]), the fluid-absorption layer (absorbent foam 126), and the fluid-wicking layer (MVTR modifying layer 122; the MVTR modifying layer is interpreted as being a fluid wicking layer because when in contact with fluid, a reaction occurs to form a poly-salt and increase the moisture permeability -para [0029;0033]) are arranged in a layered concentric configuration such that they are annular with respect to one another (as shown in figure 10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the breathable film, the fluid-absorption layer, and the fluid-wicking layer of Adie in view of Roberts so that they are arranged in a layered concentric configuration such that they are annular with respect to one another as taught by Holm since applicant has not disclosed that such a shape and arrangement of the layers solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing multiple layers within a wound dressing article.
With respect to claims 3-4, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the breathable film (140) comprises one or more polymeric layers wherein one of the polymeric layers is an adhesive (cover layer 140 typically comprises two layers such as a polyurethane film and adhesive on the film – col 12 lines 49-51).
With respect to claim 5, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the breathable film (140) covers at least 90% of the surface area of the wound dressing (as shown in figures 1A-1B, the cover layer 140 extends beyond the outer perimeter edges of layers 110 and 105 thereby completely covering these layers and forms a border region 200 as shown in fig 2 which defines the outermost perimeter edge of the dressing – thus, layer 140 in Adie is interpreted as covering the entire upper surface of the dressing – i.e. 100% of the surface area).
With respect to claim 6, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the breathable film (140) is located on an outer-facing side of the fluid absorption layer (110) (as shown in fig 1A, layer 140 is located on top of the upper surface of layer 110 which is the outer facing surface that faces away from the body during use).
With respect to claim 7, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-absorption layer (110) is a foam (col 10 lines 41-44).
With respect to claim 8, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 7) but Adie does not explicitly disclose that the fluid-absorption layer comprises gel-forming fibres, wherein the gel-forming fibres comprise an alginate, chitosan or a cellulose derivative. Holm, however, teaches a similar wound dressing which includes an absorbent layer that may be formed from alginates (para [0170]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the dressing of Adie in view of Roberts and further in view of Holm by forming the fluid-absorption layer from alginate, like the absorbent layer on the dressing of Holm, 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 claim 9, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 7) but Adie does not disclose that the fluid-absorption layer comprises an additional additive selected from the group consisting of an ion, an organic plasticiser, a surfactant, a polymer, a pH regulator, an electrolyte, a chloride source, an antimicrobial agent, a bioactive compounds and mixtures thereof. Holm, however, teaches a similar wound dressing which includes an absorbent layer that can include antimicrobial agents (para [0169]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the fluid-absorption layer in the dressing of Adie in view of Roberts and further in view of Holm by adding antimicrobial agents to the layer, as taught by Holm, in order to reduce bacterial growth and infection and thereby assist with wound healing.
With respect to claim 10, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 7) and Adie also discloses that the fluid-absorption layer (110) is a polyurethane foam (layer 110 can be allevyn foam – col 10 lines 58-60; allevyn foam is a hydrocellular polyurethane foam).
With respect to claim 11, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-absorption layer (110) is positioned laterally to the fluid-wicking layer (105) (as shown in fig 1A, layer 105 extends across the area where there is an opening in layer 110 – i.e. at 145 in fig 1A – and thus is interpreted as being positioned laterally to layer 110).
With respect to claim 12, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-absorption layer (110) partially overlaps the breathable film (110) (as shown in fig 1A).
With respect to claim 13, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-absorption layer (110) is positioned at a central area of the wound dressing (as shown in fig 1A).
With respect to claim 14, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that dressing includes a single fluid-absorption layer (110; as shown in figures 1a-1b, there is only a single layer 110 of absorbent material and the only other layers in the dressing are the cover layer 140 and the porous layer 105, neither of which are absorbent) which is a continuous layer (layer 110 extends entirely around the aperture 146 as illustrated in the top view in fig 2 as described in col 7 line 66 – col 8 line 5, and thus is interpreted as being a continuous layer).
With respect to claim 15, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie discloses that the fluid-absorption layer (110) includes an opening through the layer (aperture 146) such that the fluid absorption layer has an annular shape (i.e. the material of layer 110 has an annular configuration in the area surrounding the aperture) with the film layer (102) centrally disposed in the opening (as shown in fig 1A, the layer 102 covers the area where there is an aperture in layer 110 and therefore layer 110 is interpreted as surrounding or enclosing the layer 102 within the opening). Adie does not, however, explicitly disclose that layer 102 is transparent, but Roberts teaches “transparent dressings” for protecting wounds that provide continual visual access to the wound (col 1 lines 4-8). Thus, Roberts is interpreted as teaching that all the layers in the dressing are transparent in order to yield a dressing that, as a whole, is transparent. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Adie in view of Roberts and further in view of Holm so that the dressing is transparent as taught by Roberts so that, specifically, the area of the film layer that is centrally disposed at the opening in the fluid absorption layer is transparent in order to permit viewing through the dressing for wound inspection.
With respect to claim 16, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-absorption layer (110) comprises two portions (areas on each side of the aperture in layer 110 shown in fig 1A are interpreted as being two “portions” of layer 110) and layer 110 further includes an opening through the layer (aperture 146) with the film layer (102) positioned in the area of the opening between the two portions of layer 110 (as shown in fig 1A, the layer 102 covers the area where there is an aperture in layer 110 and therefore layer 110 is interpreted as surrounding or enclosing the layer 102 within the opening thereby providing portions of layer 110 on each side of the material of layer 102 positioned at the aperture). Adie does not, however, explicitly disclose that film layer 102 is transparent and therefore does not disclose a transparent part positioned between the two or more portions of the fluid-absorbent layer.
Roberts, however, teaches a wound dressing (window dressing 10) comprising:
A transparent breathable film (semi-permeable film layer 20; col 2 lines 44-45);
A fluid absorption layer (absorbent fiber layer 26); and
A fluid-wicking layer (porous film layer 30).
Roberts further teaches that the invention relates to “transparent dressings” for protecting wounds that provide continual visual access to the wound (col 1 lines 4-8). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Adie in view of Roberts and further in view of Holm so that the dressing comprises a transparent breathable film as taught by Roberts in order to permit viewing through the dressing for wound inspection.
With respect to claim 17, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid wicking layer (105) comprises a woven or non-woven fabric (woven spacer fabric or a non-woven fabric could be used for layer 105 – col 9 lines 55-58)
With respect to claim 18, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-wicking layer (105) is located in the central 50% of the surface area of the wound dressing (as shown in fig 1A).
With respect to claim 19, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses that the fluid-wicking layer (105) covers a majority of the surface area of the wound dressing (as shown in fig 1A) but does not explicitly disclose that the fluid-wicking layer covers, specifically, at least 75% of the surface area of the wound dressing. It would have been obvious, however, to one having ordinary skill in the art before the effective filing date of the invention to have formed the fluid-wicking layer of the device of Adie in view of Roberts and further in view of Holm so that it is sized to cover, specifically, at least 75% of the surface area of the wound dressing in order to provide fluid wicking across a large surface area to optimize fluid uptake by the dressing and, furthermore, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
With respect to claim 20, Adie in view of Roberts and further in view of Holm discloses the invention substantially as claimed (see rejection of claim 1) and Adie also discloses a non-absorbent waterproof layer (the device can include a filter 130 that is impermeable to liquids to act as a liquid barrier and ensure that no liquids escape from the dressing – col 14 lines 3-6).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 11, 14-16, 18 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-14 of U.S. Patent No. 12076216 in view of Holm (US 2011/0112457).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the present application and claim 1 of US Patent No. 12076216 differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘216 Patent is in effect a “species” of the broader, “generic” invention recited in claim 1 of the present application. Additionally, claim 1 of the present application differs from claim 1 of the ‘216 patent because the patented claims do not disclose that the breathable film, the fluid-absorption layer, and the fluid-wicking layer are arranged in a layered concentric configuration such that they are annular with respect to one another.
Holm, however, teaches a similar wound dressing (115; fig 10) wherein the breathable film (backing 118 which is a film as described in para [0106]), the fluid-absorption layer (absorbent foam 126), and the fluid-wicking layer (MVTR modifying layer 122; the MVTR modifying layer is interpreted as being a fluid wicking layer because when in contact with fluid, a reaction occurs to form a poly-salt and increase the moisture permeability -para [0029;0033]) are arranged in a layered concentric configuration such that they are annular with respect to one another (as shown in figure 10). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the breathable film, the fluid-absorption layer, and the fluid-wicking layer of the device of the ‘216 patent so that they are arranged in a layered concentric configuration such that they are annular with respect to one another as taught by Holm since such a modification appears to involve nothing more than choosing one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing multiple layers within a wound dressing article. Therefore, for at least these reasons, claim 1 of the present application is not patentably distinct from claim 1 of the ‘216 patent.
All of the limitations of claim 2 can be found in claim 1 of the ‘216 Patent; All of the limitations of claim 11 can be found in claim 1 of the ‘216 Patent; All of the limitations of claim 14 can be found in claim 10 of the ‘216 Patent; All of the limitations of claim 15 can be found in claim 11 of the ‘216 Patent; All of the limitations of claim 16 can be found in claim 12 of the ‘216 Patent; All of the limitations of claim 18 can be found in claim 13 of the ‘216 Patent; All of the limitations of claim 19 can be found in claim 14 of the ‘216 Patent.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 1/2/26 have been fully considered as follows:
Regarding the objections to the specification, Applicant’s amendments to the abstract have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome some of the objections (which have been withdrawn) while objections which have not been addressed have been maintained and new objections have been given as necessitated by the amendments to the claims.
Regarding the claim rejections under 35 USC 103, Applicant’s arguments on pages 6-8 of the Remarks 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.
Regarding the Double Patenting rejections, Applicant’s arguments have been noted but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
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