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 .
Response to Amendment
The amendment filed 11/12/2025 has been entered. Claims 90 and 95 have been amended. Claims 1-89, 94, 96-98, 112-113 and 115-118 are cancelled. Claims 90-93, 95, 99-111, 114 and 119-120 remain pending in this application. Claims 106-111 and 114 are withdrawn.
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.
Claims 90-92, 95, and 99-101 are rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani et al. (Pub. No.: US 2016/0166781 A1) in view of Lin (Pub. No.: US 2019/0030224 A1) and further in view of Vinton (Pub. No.: US 2012/0046603 A1).
Regarding claim 90, Sarangapani discloses (fig. 4-5) a dressing (116) configured to be coupled to tissue to facilitate delivery of a therapeutic gas to the tissue (abstract), the dressing comprising:
A manifold (absorbent layer 132) having an opening (fig. 4), the manifold defining a plurality of gas passageways configured to allow communication of the therapeutic gas to the tissue (¶ 0094);
A gas-occlusive layer (semi-occlusive layer 134) configured to be disposed over the manifold (fig. 4) and coupled to the tissue to form an interior volume containing the manifold (¶ 0095), the gas-occlusive layer having an opening configured to overlay the opening in the manifold (¶ 0095, fig. 4), the gas-occlusive layer configured to limit escape of the therapeutic gas from the interior volume (¶ 0095);
A patient-interface layer (wicking layer 118) in contact with the tissue (¶ 0093), the patient-interface layer defining a plurality of openings (oxygen delivery manifold 122 and mixed gas and exudates removal manifold 124) configured to allow communication of the therapeutic gas and exudate through the patient-interface layer (¶ 0093); and
One or more ports (flexible tubing 126) configured to extend through the opening in the gas-occlusive layer and the opening in the manifold (fig. 4), an end of the one or more ports disposed between a surface of the manifold proximate the tissue and the patient-interface layer (fig. 4, ¶ 0093).
Sarangapani fails to disclose: a sorbent layer configured to be disposed above the manifold and having an opening configured to overlay the opening of the manifold, the sorbent layer being formed from a foam or a non-woven textile and configured to draw exudate away from the tissue and to capture exudate.
Lin teaches (fig. 5) a dressing (150) configured to be coupled to tissue to facilitate delivery of a therapeutic gas to the tissue (¶ 0089) and thus in the same field of endeavor, comprising: a manifold (intermediary layer 170); and a sorbent layer (proximal layer 160) configured to be disposed above the manifold (fig. 5, ¶ 0090), the sorbent layer being formed from a foam or a non-woven textile (¶ 0100) and configured to draw exudate away from the tissue and to capture exudate (¶ 0095).
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 dressing of Sarangapani such that it comprises the sorbent layer of Lin, in order to aid in the transfer of exudate from the tissue (Lin, ¶ 0100).
Further, 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 sorbent layer of Sarangapani in view of Lin such that it has an opening configured to overlay the opening of the manifold in order to configure the port to pass through the occlusive layer and the manifold, such modification resulting in the opening of the gas-occlusive layer overlaying the opening of the sorbent layer and the port configured to extend through the opening in the sorbent layer.
Sarangapani in view of Lin fail to disclose a liquid control layer configured to be disposed below the manifold and to restrict communication of exudate toward the tissue, the liquid control layer comprising: a film; and a plurality of perforations, each perforation of the plurality of perforations defining an aperture having a perimeter that changes by more than 5%.
Vinton teaches (fig. 3-4) a dressing (41) configured to be coupled to facilitate delivery of a therapeutic gas to the tissue (abstract) and thus in the same field of endeavor, the dressing comprising: a liquid control layer (first, fluid impermeable layer 42) configured to restrict communication of exudate toward the tissue (¶ 0015-¶ 0016), the liquid control layer comprising: a film (¶ 0046); and a plurality of perforations (slits 51), each perforation of the plurality of perforations defining an aperture having a perimeter that changes (¶ 0047).
Vinton fails to teach a perimeter that changes by more than 5%. However, Vinton teaches the liquid control layer comprising polyethylene (¶ 0046) which is the same material as the claimed invention (specification, ¶ 0104).
It is further noted: “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985)”.
Accordingly, the feature of “each perforation of the plurality of perforations defining an aperture comprising a perimeter that changes by more than 5%” is inherent to the liquid control layer of Vinton based on the similarities between the liquid control layer of Hunt and the liquid control layer of the claimed invention.
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 dressing of Sarangapani in view of Lin such that it includes the liquid control layer of Vinton, disposed below the manifold, in order to provide optimal healing conditions for damaged tissue whilst allowing excessive fluid produced by the damaged tissue to be removed (Vinton ¶ 0011).
Regarding claim 91, Sarangapani in view of Lin and further in view of Vinton disclose wherein the sorbent layer has a plurality of perforations and/or openings configured to allow communication of the therapeutic gas to the tissue (Lin, ¶ 0100).
Regarding claim 92¸ Sarangapani in view of Lin and further in view of Vinton disclose wherein the sorbent layer comprises a superabsorbent polymer (Lin, ¶ 0100).
Regarding claim 95, Sarangapani in view of Lin and further in view of Vinton fail to disclose wherein the patient-interface layer comprises a polymer comprising one or more of silicone, polyethylene, ethylene vinyl acetate, a copolymer thereof, or a blend thereof.
Lin teaches (fig. 5) a patient-interface layer (distal layer 180), wherein the patient-interface layer comprises a polymer comprising one or more of silicone, polyethylene, ethylene vinyl acetate, a copolymer thereof, or a blend thereof (¶ 0096).
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 patient-interface layer of Sarangapani in view of Lin and further in view of Vinton such that it comprises a polymer comprising one or more of silicone, polyethylene, ethylene vinyl acetate, a copolymer thereof, or a blend thereof, as taught by Lin, as such materials are suitable as a contact layer (Lin, ¶ 0047).
Regarding claim 99, Sarangapani discloses wherein the manifold comprises polyethylene, a polyolefin, a polyether, polyurethane (¶ 0094), a co-polyester, a copolymer thereof, or a blend thereof.
Regarding claim 101, Sarangapani discloses wherein the one or more ports are configured to permit communication of the therapeutic gas through the gas-occlusive layer and into the interior volume (¶ 0093).
Claim 93 is rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 90 above, and further in view of Coulthard et al. (Pub. No.: US 2010/0305490 A1).
Regarding claim 93, Sarangapani in view of Lin and further in view of Vinton fail to disclose wherein the sorbent layer comprises a carbon filter.
Coulthard teaches (fig. 1-3) a dressing (104) configured to be coupled to tissue (see fig. 2) and thus in the same field of endeavor comprising a carbon filter that may be positioned anywhere in the dressing (¶ 0085, ln. 4-7).
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 sorbent layer of Sarangapani in view of Lin and further in view of Vinton such that it comprises a carbon filter, as suggested by Coulthard, in order to retain or prevent odor from exiting the dressing (Coulthard ¶ 0085, ln. 3-4).
Claim 100 are rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 90 above, and further in view of Hartwell (Pub. No.: US 2011/0028918 A1).
Regarding claim 100, Sarangapani in view of Lin and further in view of Vinton fail to disclose a second manifold defining a plurality of gas passageways and configured to allow communication of the therapeutic gas to the tissue, wherein the sorbent layer is configured to be disposed between the manifold and the second manifold.
Hartwell teaches (fig. 1-4) a wound dressing configured to be coupled to tissue (abstract) and thus in the same field of endeavor, comprising: a manifold (transmission layer 105); a sorbent layer absorbent layer 110), and a second manifold (further optional layer 112) defining a plurality of gas passageways and configured to allow a therapeutic gas to the tissue (¶ 0041), wherein the sorbent layer is configured to be disposed between the manifold and the second manifold.
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 dressing of Sarangapani in view of Lin and further in view of Vinton such that it includes a second manifold defining a plurality of gas passageways and configured to allow communication of the therapeutic gas to the tissue, wherein the sorbent layer is configured to be disposed between the manifold and the second manifold, as taught by Hartwell, in order to aid in the distribution of the therapeutic gas so that a whole wound site sees an equalized pressure (Hartwell, ¶ 0041).
Claims 102-103 are rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 101 above, and further in view of Mumby et al. (Pub. No.: US 2014/0249495 A1).
Regarding claim 102, Sarangapani in view of Lin and further in view of Vinton fail to disclose wherein for at least one of the one or more ports, a filter coupled to the gas-occlusive layer and configured to filter fluid that flows through the port.
Mumby teaches (fig. 15B) a dressing for configured to be coupled to tissue (abstract) and thus in the same field of endeavor comprising at least one or more ports (2150), wherein a filter (2130) is coupled to a gas-occlusive layer (cover layer 140) and configured to filter fluid through the port (¶ 0395, ln. 1-4).
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 dressing of Sarangapani in view of Lin and further in view of Vinton such that it includes the filter of Mumby in order to provide a liquid barrier that ensures that no liquids are able to escape from the wound dressing as well as provide a bacterial barrier (Mumby ¶ 0395, ln. 1-5).
Regarding claim 103, as discussed in claim 102 above, Sarangapani in view of Lin, Vinton and Mumby disclose a filter.
Mumby further teaches wherein the filter comprises polytetrafluoroethylene (¶ 0396, ln. 15), a polyester, a polyamide, a copolymer thereof or a blend thereof).
Claim 104 is rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 90 above, and further in view of Scholz et al. (Pub. No.: US 2014/0221907 A1).
Regarding claim 104, Sarangapani in view of Lin and further in view of Vinton fail to disclose a valve coupled to the gas-occlusive layer and configured to relieve pressure within the interior volume when pressure within the interior volume exceeds a threshold pressure by allowing fluid flow out of the interior volume and prevent fluid flow into the interior volume.
Scholz teaches (fig. 1-2) a dressing (100) configured to be coupled to tissue to facilitate delivery of a therapeutic gas to the tissue (¶ 0044) and thus in the same field of endeavor, comprising a valve (exit valve 190) coupled to a gas-occlusive layer (backing 110, fig. 1, ¶ 0045) and configured to relieve pressure within an interior volume (interior space 160) when pressure within the interior volume exceeds a threshold pressure by allowing fluid flow out of the interior volume and prevent fluid flow into the interior volume (¶ 0045).
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 dressing of Sarangapani in view of Lin and further in view of Vinton such that it includes a valve coupled to the gas-occlusive layer and configured to relieve pressure within the interior volume when pressure within the interior volume exceeds a threshold pressure by allowing fluid flow out of the interior volume and prevent fluid flow into the interior volume, as taught by Scholz, in order to allow pressure to be relieved to prevent over pressurization of the tissue.
Claim 105 is rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 90 above, and further in view of Eriksson et al. (Pub. No.: US 2015/0119857 A1).
Regarding claim 105, Sarangapani in view of Lin and further in view of Vinton fail to disclose a sensor configured to detect a presence of therapeutic gas within the interior volume.
Eriksson teaches (fig. 1) a device (20) configured to be coupled to tissue (abstract) comprising a sensor to detect a presence of a therapeutic gas within an interior volume (chamber space 24) (¶ 0061, ln. 1-5).
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 dressing of Sarangapani in view of Lin and further in view of Vinton such that it includes the sensor of Eriksson in order to monitor certain parameters (Eriksson ¶ 0061, ln. 1-6).
Claim 119 is rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 90 above, and further in view of Simmons (Pub. No.: US 2019/0167483 A1).
Regarding claim 119, Sarangapani in view of Lin and further in view of Vinton fail to disclose wherein the sorbent layer comprises a textured surface having a plurality of grooves.
Simmons teaches (fig. 5) a dressing configured to be coupled to tissue (abstract) and thus in the same field of endeavor, the dressing comprising a sorbent layer (dressing bolster 204), wherein the sorbent layer comprises a textured surface having a plurality of grooves (flexibility notches 218, ¶ 0046).
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 sorbent layer of Sarangapani in view of Lin and further in view of Vinton such that it includes a textured surface having a plurality of grooves, as taught by Simmons, in order to enhance the flexibility of the dressing (Simmons ¶ 0022).
Claim 120 is rejected under 35 U.S.C. 103 as being unpatentable over Sarangapani in view of Lin and further in view of Vinton, as applied to claim 90 above, and further in view of Vinton (Pub. No.: US 2015/0094646 A1), hereinafter Vinton ‘646.
Regarding claim 120, Sarangapani in view of Lin and further in view of Vinton fail to teach wherein the manifold is a manifold assembly comprising: an inner ring having the opening in the manifold; an outer ring; one or more channels coupling the inner ring to the outer ring to define a plurality of openings in the manifolding assembly between the inner ring, the outer ring, and the one or more channels; and a manifolding assembly gas-occlusive layer bonded to a surface of the inner ring, the outer ring, and the one or more channels, the manifolding assembly gas-occlusive layer being coterminous with the inner ring, the outer ring, and the one or more channels, the manifold assembly gas-occlusive layer configured to face the gas-occlusive layer; and the one or more ports configured to extend through the opening in the inner ring to distribute the therapeutic gas.
Vinton ‘646 teaches (fig. 1-2) a manifold in the form of a manifold assembly (oxygen distributor 1) for use with a dressing for treating a tissue site (¶ 0074) and thus in the same field of endeavor, the manifold assembly comprising:
an inner ring (inner track 7) having an opening (central exudate hole 8) in the manifold (¶ 0062, fig. 1);
an outer ring (circumferential track 11);
one or more channels (radial tracks or spokes 9) coupling the inner ring to the outer ring (¶ 0062) to define a plurality of openings in the manifold assembly between the inner ring, the outer ring and the one or more channels (exudate holes 12) (fig. 1, ¶ 0062); and
a manifolding assembly gas-occlusive layer (oxygen-impermeable, liquid-impermeable layer 3) bonded to a surface of the inner ring, the outer ring and the one or more channels (¶ 0062), the manifolding assembly gas-occlusive layer being coterminous with the inner ring, the outer ring and the one or more channels (¶ 0062).
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 manifold of Sarangapani in view of Lin and further in view of Vinton such that it comprises the manifold assembly of Vinton ‘646, thereby providing the manifold assembly gas-occlusive layer configured to face the gas-occlusive layer, in order to provide a manifold that supplies oxygen without covering the wound and while allowing exudate to flow freely away from the wound (Vinton ‘646 ¶ 0009).
Further, the modification of Sarangapani in view of Lin and further in view of Vinton with Vinton ‘646 results in: the one or more ports configured to extend through the opening in the inner ring to distribute the therapeutic gas.
Response to Arguments
Applicant’s arguments with respect to claim(s) 90 have been considered but are moot because the new ground of rejection does not rely on the same combination and interpretation of the previously applied references for any teaching or matter specifically challenged in the argument. Locke is no longer relied upon.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MEAGAN NGO/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781