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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 December 2025 has been entered.
Status of Claims
As directed by the amendment filed on 29 December 2025: claim(s) 38 have been amended.
Response to Arguments
Applicant's arguments filed 29 December 2025 have been fully considered but they are not persuasive.
Regarding the argument on pg. 5 that “Mulligan does not teach or suggest "wherein the wound contact layer comprises a silicone material on the first surface of the wound contact layer that extends below the manifold" as recited in amended Claim 38”, Joshi is found to disclose the wound contact layer extending below the manifold, as discussed below.
Regarding the argument on pg. 5 that “the cited paragraph of Joshi does not include the claimed features” & “the Office Action has not shown how Joshi discloses "wherein the adhesive of the cover layer and the silicone on the perforated wound contact layer contact the skin surrounding the wound" as recited in Claim 50”, Joshi discloses the adhesive of the cover layer contact the skin surrounding the wound ([0030], [0032], [0058], see discussion below) while Mulligan teaches the silicone on the perforated wound contact layer contact the skin surrounding the wound ([0026] With continued reference to FIGS. 1-2, the adhesive member 106 at least encompasses the perimeter of the wound dressing 100 … Typical adhesives can include acrylics, silicone, urethanes, hydrogels, rubber-based hydrogels and the like; FIG. 1; see discussion below).
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) 38-41, 50-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Joshi et al. (US 20070265586 A1) in view of Mulligan (US 20090012441 A1).
Regarding Claim 38, Joshi discloses a method of treating a wound ("method for wound therapy"; [0002]), the method comprising:
applying a dressing to a wound ("attached to a body surface of a patient for at least partially encompassing a wound"; [0030]), the dressing comprising
a cover layer ("housing 20"; [0030]; FIG. 1),
a manifold ("vacuum chamber 24"; [0040]; FIG. 2), and
a wound contact layer ("wound interface 41"; [0053]; FIG. 2) comprising a perforated polymer layer ("wound interface 41 may be a sheet, a foam, a gel, a gauze, a porous matrix, a honeycomb, a mop, confetti, and combinations thereof" [0053]; "wound interface 41 may be degradable copolymer foil" [0054]), the wound contact layer comprising
a first wound facing surface and an opposite second surface (“wound interface 41 in direct contact with the wound and may comprise single or multiple layers” [0053]-0056]; FIG. 2),
wherein the wound contact layer extends below the manifold (“wound interface 41 may be either placed directly inside the wound or over the wound” [0053-0056]; FIG. 2);
sealing the perforated wound contact layer to the wound ("device 10 is generally attached to the body surface of a patient using one of a variety of seals"; [0057]-[0059]; FIG. 2) and covering at least a portion of skin around the wound ("housing 20 configured to cover at least a portion of a wound"; [0030]);
fluidly coupling the dressing to a negative-pressure source ("vacuum connection 30 may connect the housing 20 and the vacuum source"; [0035]); and
applying negative pressure from the negative pressure source to the dressing ("vacuum may be communicated to the housing 20"; [0035]),
wherein the dressing maintains the seal and adherence to the wound under negative pressure ([0058]).
Joshi fails to specify the wound contact layer comprises a silicone material on the first surface of the wound contact layer. However, Mulligan teaches an analogous wound dressing 100 ([0021]; FIG. 1) wherein the wound contact layer comprises a silicone material on the first surface of the wound contact layer ("adhesive member 106 … include … silicone" [0026]; FIG. 1). Joshi’s first surface of the wound contact layer (wound interface 41) is modified to comprise Mulligan’s silicone adhesive. Joshi’s wound contact layer is configured to contact the patient’s skin, including both the wound and its perimeter. A skilled artisan would have been able to construct or coat Joshi’s first surface of the wound contact layer with Mulligan’s silicone material in order to "provide acceptable adhesion to the periwound tissue "t" surrounding the wound bed "w" skin, e.g., the periwound area, and be acceptable for use on skin without contact deterioration" ([0026]).
Regarding Claim 39, Joshi discloses a wound packer ("liquid collector"; [0040]-[0041]) positioned in a wound cavity below the dressing ("liquid-retention chamber 40 may include a liquid collector"; [0030]; FIG. 2).
Regarding Claim 40, Joshi discloses the wound packer comprises a gauze or reticulated foam material ("sponges, foams, fibers, wicking fibers, hollow fibers, beads, fabrics, or gauzes, super-absorbent materials including super-absorbent polymers in various forms, absorbent foams, gelling agents such as sodium carboxy methyl cellulose, packing materials, and combinations thereof"; [0041]).
Regarding Claim 41, Joshi discloses the wound contact layer comprises a polyurethane layer or polyethylene layer ("adhesive backed thin polyurethane films"; [0058]).
Regarding Claim 50, Joshi discloses a method of treating a wound ("method for wound therapy"; [0002]), the method comprising: applying a wound dressing to the wound and skin surrounding the wound ("attached to a body surface of a patient for at least partially encompassing a wound"; [0030]), the wound dressing comprising:
a cover layer ("housing 20"; [0030]; FIG. 1) comprising a first wound facing surface and a second surface opposite the first surface, the first surface comprising an adhesive ("flexible barrier or surface wrap may be a thin polyurethane film with a dermal compatible adhesive"; [0032]; FIG. 2);
a perforated wound contact layer ("wound interface 41 may be a sheet, a foam, a gel, a gauze, a porous matrix, a honeycomb, a mop, confetti, and combinations thereof" [0053]; "wound interface 41 may be degradable copolymer foil" [0054]; FIG. 2) comprising a first wound facing surface and a second surface opposite the first surface (see FIG. 2), ; and
wherein a portion of the first surface of the cover layer is adhered to the second surface of the wound contact layer (see FIG. 2); and
wherein the adhesive of the cover layer contact the skin surrounding the wound ("housing 20 configured to cover at least a portion of a wound" [0030]; “housing 20 is made of a flexible barrier or a surface wrap” that “may be a thin polyurethane film with a dermal compatible adhesive” [0032]; “housing 20 of the device 10 may be adapted to be sealed to a body surface of a patient” & “Adhesives, gaskets, and other seals or sealing technologies known to one of ordinary skill in the art may also be used as a seal 28 including the use of adhesive backed thin polyurethane films” [0058]);
coupling the wound dressing to a negative pressure source ("vacuum connection 30 may connect the housing 20 and the vacuum source"; [0035]); and
delivery negative pressure to the wound dressing from the negative pressure source ("vacuum may be communicated to the housing 20"; [0035]),
wherein the adhesive of the cover layer and the silicone on the perforated wound contact layer maintain the wound dressing in place when negative pressure is applied ([0058]).
Joshi fails to specify the first surface of the perforated wound contact layer comprises a silicone material contacting the skin surrounding the wound. However, Mulligan teaches an analogous wound dressing 100 ([0021]; FIG. 1) wherein the first surface of the perforated wound contact layer comprises a silicone material ("adhesive member 106 … include … silicone" [0026]; FIG. 1) contacting the skin surrounding the wound (“adhesive member 106 at least encompasses the perimeter of the wound dressing 100 to surround the wound bed” & “adhesive applied directly to the skin” [0026]; FIG. 1). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Joshi to incorporate the teachings of Mulligan to "provide acceptable adhesion to the periwound tissue "t" surrounding the wound bed "w" skin, e.g., the periwound area, and be acceptable for use on skin without contact deterioration" ([0026]).
Regarding Claim 52, Joshi discloses a transmission layer ("vacuum chamber 24"; [0040]; FIG. 2) configured to allow transmission of fluid away from a wound site and distribute negative pressure over the wound site being treated ("vacuum chamber 24 may also serve to distribute the vacuum pressure more evenly"; [0040]), wherein the transmission layer 24 is positioned between the cover layer 20 and the perforated wound contact layer 41 (see FIG. 2).
Regarding Claim 53, Joshi discloses a porous layer ("structural foam"; [0032]) positioned beneath the cover layer and above the transmission layer ("present within the internal space 22 of the housing 20"; [0032]).
Regarding Claim 54, Joshi discloses an absorbent layer ("liquid collector"; [0041]) configured to absorb fluid removed from a wound site ("assist in retaining the liquids drawn from the wound"; [0041]), wherein the absorbent layer is positioned between the cover layer and the perforated wound contact layer ("liquid-retention chamber 40 may include a liquid collector"; [0030]; FIG. 2).
Regarding Claim 55, Joshi discloses a transmission layer ("vacuum chamber 24"; [0040]; FIG. 2) configured to allow transmission of fluid away from the wound site and distribute negative pressure over the wound site being treated ("vacuum chamber 24 may also serve to distribute the vacuum pressure more evenly"; [0040]), wherein the transmission layer 24 is positioned beneath the absorbent layer and above the perforated wound contact layer 41 (“vacuum chamber 40 may also be within space defined by the adapter 32”; [0040]; NOTE: “liquid-retention chamber 40 may include a liquid collector” [0030]).
Regarding Claim 56, Joshi discloses the cover layer is configured to create a seal between the cover layer and the wound ("device 10 is generally attached to the body surface of a patient using one of a variety of seals"; [0057]-[0059]; FIG. 2).
Regarding Claim 57, Joshi discloses a negative pressure source configured to apply negative pressure to the wound ("vacuum connection 30 may connect the housing 20 and the vacuum source" & "vacuum may be communicated to the housing 20"; [0035]).
Regarding Claim 51, Joshi fails to specify the adhesive comprises an acrylic adhesive. However, Mulligan teaches an analogous wound dressing 100 ([0021]; FIG. 1) wherein the adhesive comprises an acrylic adhesive ("adhesives can include acrylics"; [0026]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Joshi/Sigurjonsson to incorporate the teachings of Mulligan to "provide acceptable adhesion to the periwound tissue "t" surrounding the wound bed "w" skin, e.g., the periwound area, and be acceptable for use on skin without contact deterioration" ([0026]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781