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 Arguments
Applicant’s arguments, see Remarks, filed 02/02/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made with the prior art combination of Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1). The negative pressure wound therapy system of Vess has both venting and suctioning features to remove wound fluid from the wound site of the patient (Figure 2; Abstract) with a dressing having a backing layer with a moisture vapor transmission rate (Paragraph 0031 and 0036; Figure 2). The rejection of claim 1 with the prior art combination will further be discussed in the rejection below. Accordingly, this action is a second Non-Final Rejection.
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) 1-2, 4-5, 7, 12, 14, 16, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1).
Regarding claim 1, Vess teaches a negative pressure wound therapy (NPWT) system (system 10; Abstract) comprising:
a dressing (dressing 12; Paragraph 0031; Figure 2) comprising:
a backing layer having moisture vapor transmission rate (MVTR) (wound cover 24 having a moisture vapor transmission rate; Paragraph 0031 and 0036; Figure 2),
an NPWT device that is configured to be carried by the user during use (vacuum source 40 and canister 28; Paragraph 0029, 0037-0038, and 0040), wherein the NPWT device comprises:
a pump (vacuum 40; Paragraph 0037-0038; Figure 2);
a remote fluid collection canister fluidly connected to said pump (collection canister 36 that is remote from vacuum 40; Paragraph 0040-0041; Figure 2).
The embodiment of Figure 2 of Vess does not teach wherein said backing layer comprises a coupling member comprising: tubing defining: a fluid conduit; and an air conduit configured to supply air to said fluid conduit and/or said dressing.
However, the embodiment of Figure 11A-11B of Vess teaches wherein said backing layer comprises a coupling member (wound port 1210 on wound dressing 1210 to connect with tubing of fluid and vent; Paragraph 0059-0060) comprising: tubing (Paragraph 0060) defining: a fluid conduit (conduit is dual lumen and having a fluid conduit; Paragraph 0060); and an air conduit configured to supply air to said fluid conduit and/or said dressing (conduit is dual lumen and having a vent conduit to supply air to the dressing; Paragraph 0060).
Vess are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Figure 2 of Vess to incorporate the teachings of the embodiment of Figure 11A-11B of Vess and have the backing layer of Vess to have the wound port with the fluid and vent lumen in one tubing connected to the vent and the vacuum, as taught by the embodiment of Figure 11A-11B of Vess. This allows for the delivery of filtered ambient air and the suction of fluids from the dressing for treatment (Vess; Paragraph 0059-0060).
The combination of Vess does not teach an adhesive skin contact layer, and an absorbent structure arranged between said backing layer and said adhesive skin contact layer, said adhesive skin contact layer being configured to detachably adhere the dressing to a dermal surface, a first connector portion, a second connector portion detachably connected to said first connector portion to form a connector unit, a battery operably coupled to the pump.
However, Askem teaches an adhesive skin contact layer (adhesive wound contact layer 1310; Paragraph 0036-0039; Figure 3C), and an absorbent structure arranged between said backing layer and said adhesive skin contact layer (absorbent layer 1322 between wound contact layer 1310 and moisture vapor permeable film layer 1313; Figure 3; Paragraph 0037); said adhesive skin contact layer being configured to detachably adhere the dressing to a dermal surface (Paragraph 0039), a first connector portion (connector 2221 that is connected to conduit 2220; Figure 1; Paragraph 0033), a second connector portion detachably connected to said first connector portion to form a connector unit (receiving connector piece that is detachably connected to connector 2221 to form a connector unit; Paragraph 0033; Figure 1), a battery operably coupled to the pump (battery is connected to source of negative pressure; Paragraph 0034).
Vess and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess to incorporate the teachings of Askem and have the adhesive skin contact layer and absorbent structure of Askem to replace the absorbent and contact layer structure of Vess, have the first connector of Askem be located at the end of the vent conduit of Vess and the second connector comprising the vent opening with the filter of Vess, to have the vacuum of Vess be operated with the battery as the power source, as taught by Askem. This allows for the dressing to be fixed onto the skin of the user and permits a unidirectional flow of exudate from the wound and to the dressing (Askem; Paragraph 0037), the disconnection of the dressing from the pump for dressing changes (Askem; Paragraph 0033), and having the battery connected to the pump to operate the device in a portable manner (Askem; Paragraph 0034).
The combination of Vess and Askem further teaches the first connector portion coupled to the fluid conduit and the air conduit (first connector portion 2221 of Askem is coupled to the fluid and vent conduit of Vess that is connected to the vent opening 1225 of Vess; Askem; Paragraph 0034; Figure 1; Vess; Figures 11A-11B; Paragraph 0059-0060), wherein the second connector portion of the connector unit defines an air entry in communication with the air conduit, wherein the air entry comprises an opening to ambient air (second connector of Askem comprises the vent opening with the filter 1225 of Vess with the opening allows ambient air to be filtered and enter through the dressing through the vent conduit; Askem; Paragraph 0034; Figure 1; Vess; Paragraph 0059-0060; Figures 11A-11B), a length of tubing extending between the second connector portion and the NPWT device and fluidly coupling the pump and the remote fluid collection canister to the dressing (remainder of the fluid lumen of Vess is the length of tubing between the second connector portion and the NPWT to fluidly couple the vacuum and canister to the dressing; Paragraph 0059-0060; Figures 2 and 11A-11B). The combination of Vess in view of Askem does not teach the backing layer having moisture vapor transmission rate in the range of from 500 to 3500 g/m2/24 h, as measured by NWSP070.4R0(15).
However, Hall teaches the backing layer having moisture vapor transmission rate in the range of from 500 to 3500 g/m2/24 h, as measured by NWSP070.4R0(15) (cover 125 has an MVTR of between 250 g/m2/24 h to 5000 g/m2/24 h; Paragraph 0055).
Vess in view of Askem and Hall are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem to incorporate the teachings of Hall and have the backing layer of Vess in view of Askem to have the MVTR range between 500 to 3500 g/m2/24 h, as taught by Hall. This allows for the dressing to have breathability when worn on the skin of the user (Hall; Paragraph 0055). The combination of Vess in view of Askem and Hall does not teach wherein the NPWT system is configured to distribute fluid from a wound so that 35% to 65% of the fluid remains within the dressing and a remainder of the fluid is removed from the dressing by the NPWT device.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the NPWT system to distribute fluid from the wound so that 35% to 65% of the fluid remains within the dressing and a remainder of the fluid is removed from the dressing by the NPWT device since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (MPEP 2144.04(IV)(A)). In the instant case, the NPWT system of Vess in view of Askem and Hall would not operate differently with the claimed range of the distribution of fluid in the dressing since the device is constructed with similar components and structure (see disclosed above) and is intended to absorb exudate through the dressing and into a canister. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the amount is “preferably” the given range and “may” extend the use of the dressing (specification; pg. 13, lines 21-26). Regarding claim 2, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall further teaches wherein said backing layer has a moisture vapor transmission rate (MVTR) in the range of from 600 to 2700 g/m2/24 h (Hall; cover 125 has an MVTR of between 250 g/m2/24 h to 5000 g/m2/24 h; Paragraph 0055).
Regarding claim 4, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not expressly teach wherein said backing layer has a tensile strength in the machine direction (MD) and/or cross-machine direction (CD) of from 30 to 70 MPa, as measured by ISO 527-3/2/200.
However, when the structure and/or composition recited in the reference(s) is substantially identical to that of the claims of the instant invention, claimed properties or functions are presumed to be inherent (MPEP 2112.01). In this case, the examiner has shown that the system of Vess in view of Askem and Hall teaches a product/apparatus/material that is substantially the same as the current claimed invention. While the examiner cannot readily determine whether or not the reference product/apparatus/material possesses the claimed properties, nonetheless a prima facie case of either anticipation or obviousness has been established. The burden of proof is now shifted to the Applicant.
Regarding claim 5, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said backing layer comprises a thermoplastic elastomer.
However, Hall teaches the cover layer can be made of polyurethanes, acrylics, polyolefin (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohols, polypropylene, polymethylpentene, polycarbonate, styreneics, silicones, fluoropolymers, and acetates (Paragraph 0077).
Hall is analogous to the claimed invention, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (backing layer of Vess in view of Askem and Hall) for another (thermoplastic elastomer backing layer as taught by Hall) since the substitution of the connectors would have yielded predictable results, namely, a detachable connector to allow for the separation of the dressing and the negative pressure wound therapy device. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B).
Regarding claim 7, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said absorbent structure comprises superabsorbent particles in an amount of from 10 to 20 mg/cm2.
However, Askem teaches wherein said absorbent structure comprises superabsorbent particles (absorbent layer 1212 has super-absorbent particles; Paragraph 0047 and 0049).
Vess in view of Askem and Hall are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Askem and have the absorbent structure of Vess in view of Askem and Hall have the super-absorbent particles as taught by Askem. This allows for the dressing to quickly and evenly distribute liquid taken from the dressing (Askem; Paragraph 0049). Vess in view of Askem and Hall does not expressly teach wherein said absorbent structure comprises superabsorbent particles in an amount of from 10 to 20 mg/cm2.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have said absorbent structure comprises superabsorbent particles in an amount of from 10 to 20 mg/cm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (MPEP 2144.04(IV)(A)). In the instant case, the absorbent structure with the superabsorbent particles of Vess in view of Askem and Hall would not operate differently with the claimed amount per cm2 since the absorbent structure is constructed with similar components and structure (see disclosed above) and is intended to absorb waste and distribute fluid in the dressing (Askem; Paragraph 0049). Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the amount is within the claimed range (specification; pg. 14, line 11-12).
Regarding claim 12, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said dressing further comprises a transmission layer arranged between said adhesive skin contact layer and said absorbent structure; said transmission layer comprising a spacer fabric.
However, Askem teaches wherein said dressing further comprises a transmission layer arranged between said adhesive skin contact layer and said absorbent structure (layer 1311 is between skin contact layer 1310 and absorbent structure 1322; Figure 3C; Paragraph 0040); said transmission layer comprising a spacer fabric (layer 1311 is made of a spacer fabric; Paragraph 0040).
Vess in view of Askem and Hall are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Askem and have the transmission layer of Askem between the adhesive skin contact layer and the absorbent structure of Vess in view of Askem and Hall. This allows for the transmission of fluids away from the wound site and into the wound dressing (Askem; Paragraph 0040).
Regarding claim 14, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall further teaches wherein said NPWT device comprises a housing in which said pump is arranged (Vess; vacuum source 40 is in a housing; Paragraph 0041; Figure 2), wherein said canister is detachably connected to said housing (Vess; canister 39 is detachably connected to housing of vacuum 40 by conduit section 36; Paragraph 0041; Figure 2).
Regarding claim 16, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall further teaches further comprising at least one adhesive strip (Askem; adhesive layer is a strip across the wound contact layer 1310; Paragraph 0039).
Regarding claim 20, Vess in view of Askem and Hall teaches the system of claim 1. Vess further teaches wherein the NPWT device further comprises a housing within which the pump is disposed (vacuum source 40 is in a housing; Paragraph 0041; Figure 2), wherein the canister is selectively attachable to the housing, wherein, by attachment of the canister to the housing, the remote fluid collection canister is fluidly connected to said pump (canister 39 is detachably attachable to housing of vacuum 40 by conduit section 36 so that the pump 40 and canister 39 are fluidly connected; Paragraph 0041; Figure 2).
Regarding claim 22, Vess in view of Askem and Hall teaches the system of claim 1. Vess further teaches wherein the canister comprises a liquid absorbent material (canister 38 contain absorbent material for containing wound fluids; Paragraph 0040).
Claim(s) 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1), as applied to claim 1 above, and further in view of Locke et al. (Publication No. US 2014/0276490 A1), hereby referred to as “Locke ‘490”.
Regarding claim 8, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said absorbent structure comprises a first liquid spreading layer, a superabsorbent layer and a second liquid spreading layer, wherein said superabsorbent layer is arranged between said first and said second liquid spreading layers.
However, Locke ‘490 teaches wherein said absorbent structure comprises a first liquid spreading layer (wicking layer 189 on top of absorbent layer 184; Paragraph 0036-0038; Figure 5), a superabsorbent layer (absorbent layer made of super-absorbents is between wicking layers 189; Paragraph 0036-0038; Fig 5) and a second liquid spreading layer (wicking layer 189 below absorbent layer 184; Paragraph 0036-0038; Figure 5), wherein said superabsorbent layer is arranged between said first and said second liquid spreading layers (absorbent layer made of super-absorbents is between wicking layers 189; Paragraph 0036-0038; Fig 5).
Locke ‘490 and Vess in view of Askem and Hall are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Locke ‘490 and have the first and second liquid spreading layers with the absorbent layer with the super-absorbent particles of Locke ‘490 replace the absorbent structure of Vess in view of Askem and Hall. This allows for the liquid to be transferred laterally along the surface of the wicking layers to be absorbed within the absorption layer and enhances the efficiency of absorption (Locke ‘490; Paragraph 0036-0037 and 0054).
Regarding claim 17, Vess in view of Askem, Hall, and Locke ‘490 teaches the system of claim 8. The combination of Vess in view of Askem, Hall, and Locke ‘490 further teaches wherein the superabsorbent layer extends to a respective perimeter of each of the first and second liquid spreading layers (Locke ‘490; sides 184a of absorbent layer 184 extend to perimeter of sides 189a of wicking layers 189; Figure 5; Paragraphs 0036-0038).
Claim(s) 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1), as applied to claim 1 above, and further in view of Whyte et al. (Patent No. US 9,795,724 B2).
Regarding claim 9, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said absorbent structure is embossed.
However, Whyte teaches wherein said absorbent structure is embossed (upstream layer and downstream layer surround absorbent layer and coupled by welding – implicit that heat welding is a form of embossing; Column 8, lines 29-49).
Whyte and Vess in view of Askem and Hall are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Whyte and have the absorbent structure comprise upstream and downstream layers surrounding the absorbent member/super-absorbent layer embossed/welded, as taught by Whyte. This allows for the periphery of the components of the absorbent layer to be coupled (Whyte; Column 8, line 40-59), wherein the first/hydrophilic layer wick liquid to the superabsorbent layer (Whyte; Column 8, line 66 to Column 9, line 10) while the second/hydrophobic layer wicks liquid not captured by the superabsorbent layer towards the top of the dressing in the hydrophilic side (Whyte; Column 9, line 43-60).
Regarding claim 11, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said dressing further comprises a liquid spreading layer arranged between said backing layer and said absorbent structure; wherein said liquid spreading layer is a configured to extend across at least 90% of the surface area of the absorbent structure and is void of an opening.
However, Whyte teaches wherein said dressing further comprises a liquid spreading layer arranged between said backing layer and said absorbent structure (hydrophobic side 134 is between layer 136 and absorbent layer 124; Figure 3; Column 9, lines 43-67), wherein said liquid spreading layer is a configured to extend across at least 90% of the surface area of the absorbent structure and is void of an opening (layer 134 covers all of the surface area of the absorbent layer and does not have an opening; Figure 3).
Whyte and Vess in view of Askem and Hall are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Whyte and have the liquid spreading/hydrophobic layer of Whyte between the backing layer and the absorbent layer of Vess in view of Askem and Hall. This allows for fluid to move through the downstream layer from the absorbent member (Whyte; Column 9, lines 43-67).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1), as applied to claim 1 above, and further in view of Mercer et al. (Publication No. US 2017/0209641 A1).
Regarding claim 10, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein said backing layer and at least a portion of said absorbent structure comprises an opening, wherein said opening is arranged underneath said coupling member.
However, Mercer teaches wherein said backing layer and at least a portion of said absorbent structure comprises an opening (dressing sealing layer 106 and absorbent assembly 186 comprises an opening 292/236; Figure 2; Paragraph 0039 and 0074), wherein said opening is arranged underneath said coupling member (openings 292/236 is underneath connector 290a; Paragraph 0039 and 0074; Figure 2).
Mercer and Vess in view of Askem and Hall are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the backing layer and the absorbent layer of Vess in view of Askem and Hall have a central opening underneath the coupling member. This allows for direct fluid communication between the dressing and the source of vacuum (Mercer; Paragraph 0074).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1), as applied to claim 1 above, and further in view of Hartwell et al. (Publication No. US 2017/0143552 A1).
Regarding claim 18, Vess in view of Askem and Hall teaches the system of claim 1. The combination of Vess in view of Askem and Hall further teaches wherein said backing layer and said adhesive skin contact layer are configured to extend beyond the periphery of the absorbent structure to form a border portion along a contour of said absorbent structure (Askem; backing layer 1313 and adhesive skin layer 1310 extend beyond periphery of absorbent structure 1322; Figure 3C; Paragraph 0037), wherein said adhesive skin contact layer comprises a plurality of apertures in the area underlying said absorbent structure (Askem; wound contact layer 1310 with adhesive is made of a perforated polyurethane film and adhesive is perforated; Paragraph 0039).
The combination Vess in view of Askem and Hall does not teach wherein the adhesive contact layer is void of apertures in the area forming said border portion, wherein the adhesive contact layer extends to a perimeter of the cover layer.
However, Hartwell teaches wherein the adhesive contact layer is void of apertures in the area forming said border portion (perimeter 305 of contact layer 350 does not have perforations; Figures 3A-C; 0055 and 0075).
Hartwell and Vess in view of Askem and Hall are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Hartwell and have the adhesive contact layer of Vess in view of Askem and Hall be void of apertures in the border portion, as taught by Hartwell. This allows for the perimeter 305 that is joined by layers 345/350 to ensure that no air is drawn in through the border area (Hartwell; 0055 and 0075).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1), as applied to claim 1 above, and further in view of Andersen et al. (Publication No. US 2016/0030722 A1).
Regarding claim 19, Vess in view of Askem and Hall teaches the NPWT system of claim 1. The combination of Vess in view of Askem and Hall does not teach wherein the connector unit and the air conduit are configured to supply air to said dressing at a rate of from 2 to 7 ml/min during operation.
However, Andersen teaches wherein the connector unit and the air conduit are configured to supply air to said dressing at a rate of from 2 to 7 ml/min during operation (gas flow is delivered to enclosed space between about 0.1 mL/min to about 10 mL/min through coupler 142/connector unit and inlet 140; Figure 1A; Paragraph 0010, 0044, and 0046-0050).
Andersen and Vess in view of Askem and Hall are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vess in view of Askem and Hall to incorporate the teachings of Andersen and have the system to supply air at the flow rate range, as taught by Andersen, through the tubing and connector of Vess in view of Askem and Hall. This allows for the air flow to provide a continuous flow of an appropriate volume of air to promote healing to the wound area (Andersen; Paragraph 0010 and 0044).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Vess et al. (Publication No. US 2010/0305524 A1) in view of Askem et al. (Publication No. US 2019/0159938 A1) and Hall et al. (Publication No. US 2020/0038283 A1), as applied to claim 1 above, and further in view of Gadde et al. (Publication No. US 2020/0078499 A1).
Regarding claim 21, Vess in view of Askem and Hall teaches the system of claim 1 above. The combination of Vess in view of Askem and Hall does not expressly teach wherein an inner volume of the canister is between from 30 ml to 300 ml.
However, Gadde teaches wherein an inner volume of the canister is between from 30 ml to 300 ml (300 mL canister 220 that is removable from housing; Paragraph 0175; Figure 2A).
Since the prior art of Gadde recognizes that 300 mL canisters are canisters compatible for being attachable to the housing of the NPWT device (Figure 2A; Paragraph 0175) and is analogous to the claimed invention in the field of negative pressure wound therapy systems, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the canister inner volume of Vess in view of Askem and Hall to be the 300 mL canister inner volume, as taught by Gadde, as it is merely the selection of functionally equivalent negative pressure wound therapy systems recognized in the art, with the function of absorbing exudate from the wound and transfer the exudate to a canister, and one of ordinary skill in the art would have a reasonable expectation of doing so. The simple substitution of one known element for another, substituting the canister inner volume of Vess in view of Askem and Hall with the with the canister inner volume of Gadde, is obvious when predictable results are achieved, with the results of collecting exudate from the wound of the user. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 - 97 (2007) (see MPEP § 2143, B.).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the inner volume of the canister to be between 30 ml to 300 ml since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (MPEP 2144.04(IV)(A)). In the instant case, the canister of Vess in view of Askem and Hall would not operate differently with the claimed inner volume since NPWT device is constructed with similar components and structure (see disclosed above) and is intended to collect wound exudate from the user. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the inner volume of the canister “may vary” and be the claimed range (specification; pg. 21, lines 25-29).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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