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 .
Election/Restrictions
Applicant’s election without traverse of Species I in the reply filed on 07/06/2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4,23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Locke et al. US 2018/0353338, hereafter Locke338.
Regarding claim 1, Locke338 discloses a dressing for treating a tissue site (abstract) with negative pressure (para. 0011), the dressing comprising: a cover (figure 5, cover [116]) comprising a first surface and a second surface opposite the first surface (where the first surface is the upper/outer facing surface and the second surface is the downward/inner facing surface); an absorbent material (205, where para. 0068 details that said layer may be hydrophilic foam and is thus interpreted as absorbent) comprising a first surface and a second surface opposite the first surface, the first surface of the absorbent material adjacent to the second surface of the cover (where the first surface is the upper/outer facing surface and the second surface is the downward/inner facing surface, and thus the first surface of the absorbent is adjacent to the second surface of the cover); an isolation layer (210) configured to restrict fluid flow from the tissue site to the absorbent material when a negative pressure is applied to the dressing (para. 0048,0054, where the second layer (210) manages fluid flow through a plurality of restrictions), the isolation layer comprising a first surface and a second surface opposite the first surface, the first surface of the isolation layer adjacent to the second surface of the absorbent material (where the first surface is the upper/outer facing surface and the second surface is the downward/inner facing surface, and thus the first surface of the isolation layer is adjacent to the second surface of the absorbent); and a manifold (505) comprising a first surface and a second surface opposite the first surface, the first surface of the manifold adjacent to the second surface of the isolation layer (where the first surface is the upper/outer facing surface and the second surface is the downward/inner facing surface, and thus the first surface of the manifold is adjacent to the second surface of the isolation layer).
Regarding claim 2, Locke338 discloses the dressing of claim 1, wherein the isolation layer is positioned between the absorbent material and the manifold (see figure 5, where the isolation layer (210) is between the absorbent (205) and the manifold (505).
Regarding claim 3, Locke338 discloses the dressing of claim 1, wherein the absorbent material is encapsulated between the cover and the isolation layer (see figure 5, where the absorbent (205) is between the cover (116) and the manifold (210). Further, as the cover creates a sealed environment (para 0037), where the absorbent and isolation layer are under the cover, it is interpreted that the absorbent layer is encapsulated below the cover and above the isolation layer.
Regarding claim 4, Locke338 discloses the dressing of claim 1, wherein the manifold is configured to be positioned between the isolation layer and the tissue site (see figure 5, where the manifold (505) is below the isolation layer (210) and in contact with the tissue site per para. 0075).
Regarding claim 23, Locke338 discloses a dressing for treating a tissue site with negative pressure (abstract, para. 0011), the dressing comprising: an absorbent material (205, where para. 0068 details that said layer may be hydrophilic foam and is thus interpreted as absorbent); a manifold (505)configured to distribute negative pressure relative to the tissue site (para. 0077); and an isolation layer (210) positioned between the absorbent material and the manifold and being configured to fluidly isolate the absorbent material from the manifold when a negative pressure is applied to the manifold (see figure 5).
Regarding claim 24, Locke338 discloses the dressing of claim 23, wherein the manifold is configured to be positioned between the isolation layer and the tissue site (see rejection of claim 23, figure 5, and para. 0076).
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) 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke338 in view of Lockwood et al. US 2005/0010153, hereafter Lockwood.
Regarding claim 13, Locke338 discloses the dressing of claim 1, wherein each of the cover, the absorbent material, and the isolation layer further comprise a negative pressure passage aligned with each other and configured to enable fluid communication between the manifold and a negative-pressure source. The examiner notes that the term negative pressure passage is broad. As Locke338 teaches suction through provided through dressing interface (255) placed over an aperture within the cover (260) providing a fluid path between the fluid conductor and tissue interface (para. 0058), it is interpreted that a negative pressure passage exists through the layers to distribute pressure to the wound site. However, in an effort to achieve compact prosecution, the examiner notes that should the claims require an additional large aperture, like seen in figure 5 of the instant application, Locke338 does not teach this.
Lockwood teaches a negative pressure wound treatment device and is thus considered analogous to the claimed invention. Lockwood teaches that a vacuum tube (34) may extend through the cover (para. 0021) and further through packing (30), where said packing is hydrophilic foam (para. 0038). The tube extends through the packing through connector (26) (see para. 0025), and negative pressure is distributed through said connector and port (60) to the channels (56,58) in a wound contacting layer (See figure 2). The examiner notes that therefore as the vacuum tube thus extends through the cover layer, packing, and layer (24) to a wound contacting layer to deliver vacuum to the wound site. Therefore, as Lockwood teaches that the vacuum configuration extending through the dressing is suitable to provide a vacuum to a wound site, it would have been obvious one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the dressing of Locke338 with a vacuum pathway (including a connector in the absorbent layer) by a means of simple substitution of one known element for another to obtain predictable results (that being applying suction through a dressing). As such a prima facie case of obviousness exists.
Regarding claim 14, Locke338 and Lockwood teach the dressing of claim 13, wherein the negative pressure passage is in direct fluid communication with the manifold and fluidly isolated from the absorbent material. The examiner notes that per the rejection of claim 13, the tubing extends through the absorbent material through the connector, and thus it is interpreted that the passage of negative pressure is isolated through the absorbent material.
Regarding claim 15, Locke338 and Lockwood teach the dressing of claim 13, wherein the negative pressure passage is configured to receive a fluid connection, and wherein the fluid connection includes a negative pressure port positioned between the second surface of the absorbent material and the manifold. The examiner notes that connector (26) includes a port (60) seen below the absorbent material and thus, upon combination the device of Locke338 and Lockwood would comprise a port between the second surface of the absorbent and the manifold.
Regarding claim 16, Locke338 and Lockwood teach the dressing of claim 15, wherein the fluid connection fluidly isolates the negative pressure port from the absorbent material. The examiner notes that as the negative pressure is provided through the cover, through a tube, and through the absorbent (through a connector), the absorbent is never in the suction pathway and thus is isolated from the negative pressure port.
Regarding claim 17, Locke338 and Lockwood teach the dressing of claim 15, wherein the fluid connection and the negative pressure port extend through the isolation layer to the first surface of the manifold. The examiner notes that the fluid connection and port, as seen in Lockwood extends through an additional layer (24) past the absorbent (through port 60) and down to a wound contacting layer (22). Thus, upon combination it is interpreted that the device of Locke338 and Lockwood would comprise a fluid connection and negative pressure port extending through the isolation layer, as this is the layer directly above the tissue interfacing layer.
Allowable Subject Matter
Claim5-8, 10, 25,27 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 5, 10, 25, and 27 Locke338 remains the closest prior art of record. The examiner notes that the defined isolation layer per the rejection of claim 1 does comprise valves. However, said valves operate to open in response to negative pressure, where the default state is closed. Various other arts teach this including Scholz US 20110106030 (para. 0059-0060), Locke US 2019/0343687 (para. 0160), where there is a flap or otherwise one-way valve that is closed and then opens when a negative pressure is provided. This disclosure is the opposite as claimed. The examiner notes that this is done in the instant application by a valve being in a default open state (valve flap upward), and the negative pressure provided from below draws the valve closed. This is best illustrated in figure 8A. The examiner notes while it can be argued that in view of Lockwood (See rejection of claim 13) the suction conduit extends into the dressing and thus provides suction from below, the valves of Locke338 even if in combination with Locke687 or Scholz would not read to the claimed invention, as the valves would have to be completely flipped and it would be uncertain if they could function in this manner, as they are biased closed. Since they are biased closed, and open upward (away from the wound) providing a suction below would seemingly just keep the valves closed, and thus not function as claimed. Flipping the valves upside-down (such that they would open toward the wound) would not have been obvious to one having ordinary skill in the art as it would require a complete overhaul of valve function, with no guarantee that the valves would stay in a default open position even with said construction. As such, none of the cited prior art reads to the claimed invention.
Claims 6-8 depend from claim 5 and thus are objected to for the same reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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