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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the gap recited in Claims 2, 6-8, 15, and 19-20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide antecedent basis for the gap recited in Claims 2, 6-8, 15, and 19-20.
Claim Objections
Claim 12 recites the limitation “the cover layer” which should be revised to “the covering layer”.
Claim 13 recites the limitation “wherein the adherent layer wherein an innermost portion of the adherent layer” which requires revision. For the purpose of compact prosecution, this limitation is interpreted as “wherein an innermost portion of the adherent layer”.
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, 5-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Merckel et al (US 2022/0062059) in view of Bishop et al (US 2021/0196525).
Regarding Claim 1, Merckel discloses a wound dressing (10, Fig. 2) defining a first direction that is a stacking direction (up and down direction, Fig. 2) of the wound dressing (10, Fig. 2) and a second direction (left and right direction, Fig. 2) perpendicular to the first direction (up and down direction, Fig. 2), the wound dressing (10, Fig. 2) comprising:
a covering layer (backing layer 11, Fig. 2);
a sheath (envelope 14, Fig. 2) on the wound facing side of the covering layer (1, Fig. 2);
an absorbent core (15, Fig. 2) within the sheath (14, Fig. 2); and
an adherent layer (wound contact layer 13, Fig. 2) on the wound facing side of the sheath (14, Fig. 2);
wherein the sheath (14, Fig. 2) comprises:
a proximal sheath layer (14a, Fig. 2) on the proximal side of the absorbent core (15, Fig. 2), and
a distal sheath layer (14b, Fig. 2) on the distal side of the absorbent core (15, Fig. 2),
wherein the adherent layer (13, Fig. 2) comprises an opening (centermost aperture 13c, Fig. 2),
wherein the adherent layer (13, Fig. 2) comprises:
a wound facing proximal side (skin-friendly silicone adhesive 13b, Fig. 2) adapted to adhere to a body part (¶ [0075]), and
a distal side (perforated sheet material 13a, Fig. 2) adhering to an outer rim (border area 17, Fig. 2) of the covering layer (11, Fig. 2).
Merckel is silent whether the sheath comprises an adhesive sheath layer, wherein the proximal sheath layer is on the proximal side of the adhesive sheath layer, wherein the distal sheath layer is on the distal side of the adhesive sheath layer, and wherein the adhesive sheath layer is between the absorbent core and the distal sheath layer.
Bishop teaches a wound dressing, thus being in the same field of endeavor, with a sheath comprising an adhesive sheath layer (bonding layer 240, Fig. 5) and an absorbent core (210, Fig. 5) within the sheath, wherein the proximal sheath layer (250, Fig. 5) is on the proximal sides of the absorbent core (210, Fig. 5) and the adhesive sheath layer (240, Fig. 5), wherein the distal sheath layer (220, Fig. 5) is on the distal sides of the absorbent core (210, Fig. 5) and the adhesive sheath layer (240, Fig. 5), and wherein the adhesive sheath layer (240, Fig. 5) is between the absorbent core (210, Fig. 5) and the distal sheath layer (250, Fig. 5). Bonding the absorbent core to the overlying sheath layer, rather than simply bonding the peripheral edges of the sheath together, improves the structural integrity of the dressing (¶ [0079]).
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 sheath of Merckel to include an adhesive sheath layer, where the proximal sheath layer is on the proximal side of the adhesive sheath layer, wherein the distal sheath layer is on the distal side of the adhesive sheath layer, and wherein the adhesive sheath layer is between the absorbent core and the distal sheath layer, as taught by Bishop. This improves the structural integrity of the dressing compared to just bonding the edges of the sheath together (as motivated by Bishop ¶ [0079]).
Regarding Claim 14, Merckel discloses a method of forming a wound dressing (10, Fig. 2) defining a first direction (up and down direction, Fig. 2) that is a stacking direction of the wound dressing (10, Fig. 2) and a second direction (left and right direction, Fig. 2) perpendicular to the first direction (up and down direction, Fig. 2), the method comprising:
arranging a sheath (envelope 14, Fig. 2) on the wound facing side of a covering layer (backing layer 11, Fig. 2);
arranging an absorbent core (15, Fig. 2) within the sheath (14, Fig. 2); and
arranging an adherent layer (wound contact layer 13, Fig. 2) on the wound facing side of the sheath (14, Fig. 2),
wherein the sheath (14, Fig. 2) comprises:
a proximal sheath layer (14a, Fig. 2) on the proximal side of the absorbent core (15, Fig. 2), and
a distal sheath layer (14b, Fig. 2) on the distal side of the absorbent core (15, Fig. 2),
wherein the adherent layer (13, Fig. 2) comprises an opening (centermost aperture 13c, Fig. 2),
wherein the adherent layer (13, Fig. 2) comprises:
a wound facing proximal side (skin-friendly silicone adhesive 13b, Fig. 2) adapted to adhere to a body part (¶ [0075]), and
a distal side (perforated sheet material 13a, Fig. 2) adhering to an outer rim (border area 17, Fig. 2) of the covering layer (11, Fig. 2).
Merckel is silent whether the sheath comprises an adhesive sheath layer, wherein the proximal sheath layer is on the proximal side of the adhesive sheath layer, wherein the distal sheath layer is on the distal side of the adhesive sheath layer, and wherein the adhesive sheath layer is between the absorbent core and the distal sheath layer.
Bishop teaches a wound dressing, thus being in the same field of endeavor, with a sheath comprising an adhesive sheath layer (bonding layer 240, Fig. 5) and an absorbent core (210, Fig. 5) within the sheath, wherein the proximal sheath layer (250, Fig. 5) is on the proximal sides of the absorbent core (210, Fig. 5) and the adhesive sheath layer (240, Fig. 5), wherein the distal sheath layer (220, Fig. 5) is on the distal sides of the absorbent core (210, Fig. 5) and the adhesive sheath layer (240, Fig. 5), and wherein the adhesive sheath layer (240, Fig. 5) is between the absorbent core (210, Fig. 5) and the distal sheath layer (250, Fig. 5). Bonding the absorbent core to the overlying sheath layer, rather than simply bonding the peripheral edges of the sheath together, improves the structural integrity of the dressing (¶ [0079]).
Therefore, it would have been obvious to modify the sheath of Merckel to include an adhesive sheath layer, where the proximal sheath layer is on the proximal side of the adhesive sheath layer, wherein the distal sheath layer is on the distal side of the adhesive sheath layer, and wherein the adhesive sheath layer is between the absorbent core and the distal sheath layer, as taught by Bishop. This improves the structural integrity of the dressing compared to just bonding the edges of the sheath together (as motivated by Bishop ¶ [0079]).
Regarding Claims 2 and 15, Merckel/Bishop further discloses the claimed invention substantially as claimed as set forth above for Claims 1 or 14.
The combination of Merckel/Bishop further discloses a gap is formed between the adhesive sheath layer and the absorbent core along the second direction, as there will be a gap in the left and right direction between the adhesive sheath layer and the absorbent core where the distal sheath layer/adhesive sheath layer is arranged diagonally as seen in Fig. 2 of Merckel.
Regarding Claims 3 and 16, Merckel further discloses the opening (centermost aperture 13c, Fig. 2) is smaller than the absorbent core (15, Fig. 2) along the second direction (left and right direction, Fig. 2).
Regarding Claims 5 and 18, Merckel further discloses the proximal sheath layer (14a, Fig. 2) and the distal sheath layer (14b, Fig. 2) comprises a non-woven material (¶ [0075]).
Regarding Claims 6 and 19, Merckel further discloses a gap is formed between a portion of the distal sheath layer (14b, Fig. 2) and the covering layer (11, Fig. 2) along the first direction (up and down direction, Fig. 2; there is a gap between 11 and 14b along the diagonal edges as seen in Fig. 2).
Regarding Claims 7 and 20, Merckel further discloses a gap is formed between a portion of the distal sheath layer (14b, Fig. 2) and the covering layer (11, Fig. 2) along the second direction (left and right direction, Fig. 2; there is a gap between 11 and 14b along the diagonal edges as seen in Fig. 2).
Regarding Claim 8, Merckel discloses a gap is formed between an entirety of the distal sheath layer (14b, Fig. 2) and the covering layer (11, Fig. 2) along the second direction (left and right direction, Fig. 2; ¶ [0075] indicates the covering layer is coated with a layer of adhesive, and this layer of adhesive fills the gap between the distal sheath layer and the covering layer).
Regarding Claim 9, Merckel further discloses the proximal sheath layer (14a, Fig. 2) is formed as a flat sheet (as seen in Fig. 2).
Regarding Claim 10, Merckel further discloses the proximal sheath layer (14a, Fig. 2) has a flat portion that is larger than the absorbent core (15, Fig. 1) along the second direction (left and right direction, Fig. 2).
Regarding Claim 11, Merckel further discloses the covering layer (11, Fig. 2) has a flat portion that is larger than the opening (centermost aperture 13c, Fig. 2) along the second direction (left and right direction, Fig. 2).
Regarding Claim 12, Merckel further discloses the covering layer (11, Fig. 2) has a height along the first direction (up and down direction, Fig. 2) that is greater than a height of the sheath (14, Fig. 2) along the first direction (up and down direction, Fig. 2; as seen in Fig. 2, the covering layer is above the sheath, and therefore has a greater height than the sheath).
Regarding Claim 13, Merkel/Bishop discloses the claimed invention substantially as claimed as set forth above for Claim 1.
Merckel/Bishop further discloses an innermost portion of the adherent layer (Merckel 13, Fig. 2) along the first direction (Merckel up and down direction, Fig. 2) overlaps a portion of the proximal sheath layer (Merckel 14a, Fig. 2) that is not in contact with the adhesive sheath layer (since the combination of Merckel/Bishop has the adhesive sheath layer on the distal sheath layer, the innermost portion of the adherent layer along the first direction will overlap a portion of the proximal sheath layer that isn’t in contact with the adhesive sheath layer, because at that point the proximal sheath layer is in contact with the absorbent core instead of the adhesive sheath layer).
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Merckel et al (US 2022/0062059) in view of Bishop et al (US 2021/0196525) further in view of Cotton (US 2016/0067107).
Regarding Claims 4 and 17, Merckel further discloses the adherent layer (13, Fig. 2) comprises a first adhesive (13b, Fig. 2) comprising silicone (¶ [0075]) on the wound facing proximal side (13b, Fig. 2).
Merckel/Bishop is silent whether the adherent layer comprises a second adhesive comprising an acrylic adhesive on the distal side.
Cotton teaches a wound dressing, thus being in the same field of endeavor, with an adherent layer (skin contact layer 16, Fig. 2) comprising a first silicone adhesive on its proximal side and a second acrylic adhesive on its distal side (¶ [0063]). The second acrylic adhesive allows the skin contact layer to securely attach to the backing layer (¶ [0063]).
Therefore, it would have been obvious to modify the adherent layer of Merckel/Bishop to include a second acrylic adhesive on its distal side, as taught by Cotton, to ensure the adherent layer is able to securely attach to the backing layer to improve the integrity of the wound dressing (as motivated by Cotton ¶ [0063]).
Conclusion
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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