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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2026 has been entered.
Response to Amendment
The amendment filed 05/19/2026 has been entered. Claims 74 and 83 have been amended. Claims 1-65, 68, 70, 77, 84, 87, 92, 94-96, 99-100, 109 and 117 are cancelled. Claims 66-67, 69, 71-79, 78-83, 85-86, 88-91, 93, 97-98, 101-108, 110-116 remain pending in this application. Claims 66-67, 69, 71-73, 97-98, 101-108, 110-116 are withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 74 have been considered but are moot because the new ground of rejection does not rely on the same interpretation of Hartwell for any teaching or matter specifically challenged in the argument. Claim 74 has been amended to recite the fluid distribution vessel including a plurality of outlets configured to be positioned in the sealed space separate from and facing the second surface of the occlusive layer. Hartwell discloses a layer of the fluid distribution vessel comprising pores, as discussed in the rejection below.
Claim Rejections - 35 USC § 103
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) 74-76, 79-80, 82, 86, 89, 91, and 93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell (Pub. No.: US 2016/0106892 A1).
Regarding claim 74, Hartwell discloses (fig. 1A, 2, 3D, annotated fig. 3D) a system (100) for treating a tissue site (¶ 0081), comprising:
A drape (170) configured to provide a sealed space at the tissue site (¶ 0084);
An occlusive layer (manifold top layer 372 formed by the distal end of intermediate layer 333, which may be formed from a polyurethane film, ¶ 0093 and thus occlusive) configured to be positioned entirely within the sealed space (see manifold 140, fig. 1A, 2) and including a first surface and a second surface on an opposite side of the occlusive layer from the first surface (annotated fig. 3D);
A fluid removal manifold (characterized by spacer layer 342, top layer 332 and intermediate layer 333) comprising foam (¶ 0099, ¶ 0104); and
A fluid distribution vessel (characterized by spacer layer 344, bottom layer 334 and intermediate layer 333) (¶ 0104), the fluid distribution vessel including a plurality of outlets (pores 375) configured to be positioned in the sealed space separate from the occlusive layer (fig. 1A, ¶ 0105).
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Hartwell annotated fig. 3D
Hartwell fails to disclose in the embodiment of fig. 3D that the fluid removal manifold is positioned adjacent the first surface of the occlusive layer and configured to be positioned between the first surface of the occlusive layer and the tissue site; and the fluid distribution vessel is configured to be positioned adjacent the second surface of the occlusive layer and between the second surface of the occlusive layer and the drape such that at least a portion of the occlusive layer is positioned between the fluid distribution vessel and the fluid removal manifold, the plurality of outlets configured to be facing the second surface of the occlusive layer.
However, Hartwell discloses that one of the upper and lower fluid passages comprising the spacer material is configured to provide aspiration to the wound site and the other of the upper and lower fluid passages is configured to provide irrigation fluid to the wound side (¶ 0017-¶ 0018).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the fluid removal manifold and fluid distribution vessel in the embodiment of fig. 3D of Hartwell such that the fluid removal manifold is positioned adjacent the first surface of the occlusive layer and configured to be positioned between the first surface of the occlusive layer and the tissue site; and the fluid distribution vessel is positioned adjacent the second surface of the occlusive layer and between the second surface of the occlusive layer and the drape such that at least a portion of the occlusive layer is positioned between the fluid distribution vessel and the fluid removal manifold, and the plurality of outlets configured to be facing the second surface of the occlusive layer, as taught by Hartwell, as such arrangement provides the predictable results of a system configured to transmit irrigation and apply aspiration (Hartwell, abstract).
Shifting the position of the fluid removal manifold and the fluid distribution vessel would not have modified the operation of the system and is held to be an obvious matter of design choice (MPEP §2144.04.VI.C).
Regarding claim 75, Hartwell discloses a negative-pressure source configured to be fluidly connected to the fluid removal manifold; and a fluid source configured to be fluidly connected to the fluid distribution vessel (¶ 0083, ¶ 0104).
Regarding claim 76, Hartwell discloses a conduit (120), wherein the conduit has a first fluid channel in fluid communication with the fluid removal manifold and a second fluid channel in fluid communication with the fluid distribution vessel (¶ 0083, ¶ 0104).
Regarding claim 79, Hartwell discloses wherein a plurality of fluid delivery passages that are formed on the second surface of the occlusive layer (the occlusive layer comprises a plurality of radially extending arms, fig. 1A, 3D, ¶ 0107).
Regarding claim 80, Hartwell discloses wherein the plurality of fluid delivery passages extend radially across the second surface of the occlusive layer (fig. 1A, 3D, ¶ 0107).
Regarding claim 82, Hartwell discloses wherein the fluid distribution vessel comprises a polyurethane film that is welded around a perimeter to provide an interior volume (¶ 0093, ¶ 0096).
Regarding claim 86, Hartwell discloses wherein the fluid distribution vessel comprises a plurality of compartments formed by welds within an interior volume of the fluid distribution vessel (¶ 0093, ¶ 0095, fig. 3D, compartments characterized by manifold 370).
Regarding claim 89, Hartwell discloses wherein the occlusive layer comprises a polyurethane film (manifold top layer 372 formed by the distal end of intermediate layer 333, which may be formed from a polyurethane film, ¶ 0093).
Regarding claim 91, Hartwell discloses wherein the fluid removal manifold comprises a plurality of welded polyurethane films (¶ 0093, ¶ 0095).
Regarding claim 93, Hartwell discloses wherein the fluid removal manifold comprises a first surface having a plurality of fenestrations (the spacer material is porous ¶ 0019).
Claim(s) 78 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartwell, as applied to claim 74 above, and further in view of Hardman et al. (Pub. No.: US 2010/0106115 A1).
Regarding claim 78, Hartwell fails to disclose wherein the occlusive layer comprises a plurality of removal passageways formed on the first surface of the occlusive layer.
Hardman teaches (fig. 1A-2) a system (100) for treating a tissue site (¶ 0024) and thus in the same field of endeavor, comprising: an occlusive layer (non-adherent drape 148 formed of a polyurethane film ¶ 0034 and thus occlusive), wherein the occlusive layer comprises a plurality of removal passageways (encapsulated leg members 106) formed on a first surface of the occlusive layer (fig. 1C-2, ¶ 0047).
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 occlusive layer of Hartwell such that it comprises a plurality of removal passageways formed on the first surface of the occlusive layer, as taught by Hartwell, in order to allow for the distribution of reduced pressure in order to remove fluids (Hartwell, abstract).
Regarding claim 81, Hartwell in view of Hardman disclose wherein the plurality of fluid removal passageways extend radially across the first surface of the occlusive layer (Hardman fig. 2).
Claim 90 is rejected under 35 U.S.C. 103 as being unpatentable over Hartwell, as applied to claim 74 above, in view of Bowen (US Pat. No.: 5,827,246).
Regarding claim 90, Hartwell fails to disclose wherein the occlusive layer comprises a plurality of pleats forming a plurality of fluid removal passageways on the first surface of the occlusive layer and a plurality of fluid delivery passages on the second surface of the occlusive layer.
Bowen teaches (fig. 1-2, 3B) a system (fluid collection system 20) for treating a tissue site (abstract) and thus in the same field of endeavor, comprising an occlusive layer (corrugated ribs 50 formed from corrugated plastic panel 44, col. 6, ln. 4-7), wherein the occlusive layer comprises a plurality of pleats (corrugated ribs 50b) forming a plurality of fluid passageways (fluid flow channels 52b) (fig. 3B, col. 7, ln. 8-11).
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 occlusive layer of Hartwell such that it comprises a plurality of pleats, as taught by Bowen, thereby forming a plurality of fluid removal passageways on the first surface of the occlusive layer and a plurality of fluid delivery passages on the second surface of the occlusive layer, in order to provide a low cost occlusive layer (Bowen col. 2, ln. 34-37).
Allowable Subject Matter
Claims 83, 85 and 88 are 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:
Claim 83 recites “the fluid distribution vessel comprises tubing including the plurality of outlets”. As discussed above in claim 74, Hartwell discloses the fluid distribution vessel including a plurality of outlets (pores 375). Hartwell discloses that the outlets are formed on the manifold layer (374) (¶ 0105). Hartwell fails to disclose tubing including the plurality of outlets. Shuler et al. (Pub. No.: US 2017/0028113 A1) discloses (fig. 1-4) a system (100) comprising a fluid distribution vessel (irrigation network 130) comprising a plurality of outlets (see lumen 136), the fluid distribution vessel comprising tubing (134) including the plurality of outlets (¶ 0034). However, such modification of the outlets of Hartwell such that they are including in the tubing of Shuler requires a substantial modification to the fluid distribution vessel of Hartwell. The outlets of Hartwell are formed on a layer of the manifold while the outlets of Shuler are formed by two sealed edges (¶ 0053). Such modification is nonobvious.
Further, while Shuler discloses a fluid removal manifold (vacuum interface chamber 150) and the fluid distribution vessel (irrigation network 130), Shuler fails to disclose, teach or suggest an occlusive layer between the fluid removal manifold and fluid distribution vessel. Rather, Shuler discloses a layer (dorsal perforated layer 142) between the fluid removal manifold and fluid distribution vessel that is non-occlusive, teaching away from an occlusive layer.
Similarly, Martin (Pub. No.: US 2007/0293830 A1) discloses a system comprising a fluid removal manifold and a fluid distribution vessel including tubing including a plurality of outlets. However, Martin fails to disclose the claimed occlusive layer.
Claims 85 and 88 depend from claim 83 and also include allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Balasubramaniam (Pub. No.: US 2017/0049943 A1) discloses a system comprising pleats.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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