DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
This Office action is in response to communications filed January 20, 2026.
Election/Restrictions
1. Applicant’s election without traverse of Group I, claims 135-148 in the reply filed on January 20, 2026 is acknowledged. Claims 149-154 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
2. Claims 135-148 are pending and currently under consideration for patentability.
Claims 149-154 are canceled as of the January 20, 2025 response to restriction/election.
Priority
3. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on January 20, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
5. Claims 143-148 are objected to because of the following informalities:
Each of claims 143-148 preamble reads as “The wound dressing of Claim [X]…”; however, each of these claims depend from independent claim 142, which discloses “A wound treatment apparatus…”.
Accordingly, examiner suggests the following preamble language: --- The wound treatment apparatus of Claim [X]…---.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
6. Claims 135-139 and 142-146 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ambrosio (US PGPUB 2007/0185426 A1) in view of Flick et al. (US PGPUB 2006/0264796 A1).
7. With regard to claims 135 and 142, Ambrosio discloses a wound treatment apparatus (reduced pressure delivery system, 211; Fig. 2; abstract), comprising: a vacuum pump (reduced pressure source, 219) configured to deliver negative pressure ([0050]); a gas impermeable cover layer (membrane, 224; “airtight seal”; [0044]) comprising a fluid passage (aperture in 224 for attachment to tubing connector, 220; [0050]); a suction port (tubing connector, 220) configured to connect to the vacuum pump (219), the suction port (220) positioned above the fluid passage (Fig. 2; [0050]); an absorbent layer (third layer, 227) configured to absorb wound exudate ([0066-0068]; [0051]); and a transmission layer (second layer, 225) positioned beneath the absorbent layer (227; Fig. 2; [0051]), the transmission layer (225) comprising a first surface and a second surface (inherent upper and lower surfaces; see Fig. 4), the transmission layer (235) comprising a plurality of spacer elements (release material, 235; [0057-0059]).
While Ambrosio discloses that the plurality of spacer elements (235) and/or the transmission layer (225) minimizes points of contact between the layers of the dressing (213; [0057]), Ambrosio fails to explicitly disclose that the transmission layer comprises a first surface and a second surface, the transmission layer comprises a plurality of spacer elements having lateral stiffness and extending perpendicularly between the first surface and the second surface, the lateral stiffness of the spacer elements configured to dissipate force operating over a first area on the first surface to a second area on the second surface.
However, within the same field of endeavor (NPWT devices), Flick discloses a wound treatment apparatus (wound dressing, 400; Fig. 4; abstract), comprising: a transmission layer (conformable, conductive substrate, 10) comprising a first surface and a second surface (“two layers of conformable conductive fabric”; [0098]), the transmission layer (10) comprising a plurality of spacer elements (a plurality of supports, 15) having lateral stiffness and extending perpendicularly between the first surface and the second surface (Fig. 4; [0098]), the lateral stiffness of the spacer elements (15) configured to dissipate force operating over a first area on the first surface to a second area on the second surface ([0039]). Flick also suggests additional wound dressing layers, such as an absorbent layer (14; Fig. 3) and cover layer ([0039]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the transmission layer disclosed by Ambrosio to include a first surface, a second surface, and a plurality of spacer elements having lateral stiffness and extending perpendicularly between the first surface and the second surface, similar to that disclosed by Flick, in order to provide support to additional layers of the dressing during use, while also permitting transmission of fluids through the dressing, as suggested by Flick in paragraph [0039], and to further minimizes points of contact between the layers of the dressing, as suggested by Ambrosio in paragraph [0057].
With further regard to claim 135, Ambrosio is silent in regard to the absorbent layer comprising a through hole positioned beneath the fluid passage.
However, Flick discloses that through holes of any number, size and location may be provided through any layers of the wound dressing ([0043]); and notably that in embodiments useful with negative pressure therapies, an aperture can be provided to facilitate the generation of a vacuum without becoming blocked by fluid in the wound ([0087]; [0138-0140]; [0193]).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the absorbent layer disclosed by Ambrosio to include a through hole positioned beneath the fluid passage, similar to that suggested by Flick, in order to facilitate the generation of a vacuum without becoming blocked by fluid in the wound, as suggested by Flick in paragraph [0087], such as a large aperture improving moisture level regulation and liquid removal from the absorbent layer, as suggested by Flick in paragraphs [0138-0139].
8. With regard to claims 136 and 143, Ambrosio, as modified by Flick above, discloses the transmission layer of claims 135 and 142. Flick further discloses that first surface is the upper surface of the transmission layer (10) and the second surface is the bottom surface of the transmission layer (10; Fig. 4; “two layers of conformable conductive fabric”; [0098]).
9. With regard to claims 137-139 and 144-146, Ambrosio, as modified by Flick above, discloses the wound dressing and treatment apparatus of claims 135 and 142. Ambrosio further discloses a wound contact (tissue contact layer, 223) layer positioned beneath the transmission layer (225; Fig. 2; [0051]; [0054]); wherein the wound contact layer (223) is configured to overlie a wound area (tissue site, 221) and an area of body surface adjacent the wound area (especially evident in smaller surface wounds like that seen in Fig. 1) at least partially enclosing the wound area (Figs. 1, 2; [0013]; [0051]; [0054]; [0057]; [0069]); wherein the wound contact layer (225) comprises a plurality of apertures (flow channels, 234; Fig. 2; [0051]; [0053-0054]; [0070]).
10. Claims 140-141 and 147-148 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ambrosio in view of Flick, as applied to claims 135 and 142 above, and further in view of Vitaris (US PGPUB 2009/0234307 A1).
11. With regard to claims 140 and 147, Ambrosio, as modified by Flick above, discloses the wound contact layer of claims 138 and 145.
While Ambrosio suggests the use of pressure sensitive, acrylic adhesives for sealing application over the wound site (12; [0041]) and further suggests the use of adhesive fasteners to connect adjacent layers of the wound dressing to one another ([0052]), Ambrosio and Flick fail to explicitly disclose that the wound contact layer comprises a silicone adhesive.
However, within the same field of endeavor (NPWT), Vitaris discloses a vacuum port for a vacuum wound therapy system (10; abstract; [0031]; Figs. 1, 4A, 4B), comprising: a wound contact layer (34; [0036-0038]) which comprises a silicone adhesive (adhesive layer, 48; [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the dressing disclosed by Ambrosio in view of Flick to include a silicone adhesive, similar to that disclosed by Vitaris, in order to provide a fluid-tight and bacteria-tight seal around a peripheral region of dressing such that exudate cannot escape through the edges of the dressing and external air and contaminants may not enter the wound area, as suggested by Vitaris in paragraph [0039], while additionally providing a connection between adjacent dressing layers, as suggested by Ambrosio in paragraph [0052].
12. With regard to claims 141 and 148, Ambrosio, as modified by Flick above, discloses the wound dressing and treatment apparatus and cover layer of claims 135 and 142.
However, while the cover layer (224) of Ambrosio is positioned over the absorbent layer (227; Fig. 2), Ambrosio and Flick fail to explicitly disclose that the cover layer comprises a moisture vapor permeable cover layer.
Vitaris discloses a vacuum port for a vacuum wound therapy system (10; abstract; [0031]; Figs. 1, 4A, 4B), comprising: a cover layer (backing layer, 44) comprises a moisture vapor permeable cover layer ([0042]) positioned over an absorbent layer (38; Figs. 1, 4A, 4B; [0038]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the cover layer disclosed by Ambrosio in view of Flick to be a moisture vapor permeable cover layer, similar to that disclosed by Vitaris, in order to promote the exchange of oxygen and moisture vapor between the wound site and the atmosphere, as suggested by Vitaris in paragraph [0042].
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bentley et al.(US PGPUB 2009/0105670) discloses a suction assisted wound treatment system.
Fleischmann (US PGPUB 2008/0167593) discloses a wound treatment device.
Zamierowski (US PGPUB 2007/0038172) discloses a gradient wound treatment system.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781