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 amendments filed on 07/31/2026 have been entered. Claims 1-6 and 10-21 are pending in this application. Claims 1, 11, 14, and 16-18 are amended. Claims 19-21 are newly added. Claims 7-9 are cancelled.
Response to Arguments
Applicant’s arguments with respect to amended claims 1 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though some of the same prior art reference is re-used herein, amended claims 1 and 17 and newly added claims 19-21 required a change in the grounds of rejection as detailed below in the prior art rejection. More specifically, the amended claim limitation requires the backing layer to have the MVTR range and the adhesive skin contact layer to be made of a laminate of polyurethane film and silicone gel which changes the scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 17 and its dependents are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 17 requires the limitation “wherein the at least one polyurethane film is positioned between the silicone gel layer and the dressing so that the silicone gel layer forms a skin contact surface of the adhesive skin contact layer and the at least one polyurethane film forms an upper surface of the laminate”. The claim renders indefinite since it is unclear how the polyurethane film of the laminate that is a part of the adhesive contact layer that makes up the dressing can be located between the silicone gel layer and the dressing. It is unclear how the polyurethane film, which is a component in the dressing, can be apart and adjacent to the dressing. For the purposes of examination, it is interpreted that the claim limitation requires that the polyurethane film layer is between the silicone gel layer and the absorbent structure, as discussed in Figures 4B-4C and Page 19 of the Specification of the Instant Application.
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) 1-3, 6, 10-11, 13, 15, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), and Edwards et al. (Publication No. WO 2019/083726 A1).
Regarding claim 1, Nilsson teaches a negative pressure wound therapy (NPWT) system (Figure 1; Abstract) comprising;
a negative pressure wound therapy (NPWT) device (negative pressure source 23; Figure 1; Abstract; Paragraph 0056), the NWPT device comprising a housing (source 23 has a housing; Figure 1; Abstract), a negative pressure pump arranged within said housing and a canister detachably connected to said housing (source 23 is a pump and has a canister; Figure 1; Paragraph 0033 and 0056-0057),
an absorbent or non-absorbent dressing (wound cover member 24 with wound filler 27 is absorbent; Figure 1; Paragraph 0054-0055), wherein said non-absorbent or absorbent dressing comprises at least a backing layer (wound cover member 24; Figure 1; Paragraph 0054-0055) and an adhesive skin contact layer (adhesive skin contact layer; Figure 1; Paragraph 0055), and
a tubing assembly configured to fluidly connect said absorbent or non-absorbent dressing to said NPWT device (connector device 1 with conduits 21, 22, and 7; Figure 1; Abstract; Paragraph 0056-0057 and 0060), wherein said tubing assembly comprises:
a first connector portion (wound side connector 25; Abstract; Figure 1);
a first tubing configured to be connected to said dressing (wound side assembly 19 having conduits 21 and 22 to be connected to dressing 24/27; Figure 1; Abstract), wherein a distal end of said first tubing is attached to the first connector portion (distal end of tubing 19 is connected to first connector portion 25; Abstract; Figure 1; Paragraph 0070);
a second connector portion configured to be detachably connected to said first connector portion (connector housing 2 is detachably connected to connector 25; Figure 1; Abstract); and
a second tubing configured to be connected to said canister (tubing 7 is connected to source 23 having a canister; Figure 1; Paragraph 0056-0057; Abstract), wherein a distal end of said second tubing is attached to the second connector portion (distal end of tubing 7 is attached to connector housing 2; Figure 1; Abstract; Paragraph 0058-0060),
wherein said system comprises a flow path (flow path is air supplying conduit 22; Figure 1; Abstract),
wherein the first and second connector portion cooperate to define a connector unit (connector housing 2 and connector 25 make up the connector device 1; Figure 1; Abstract; Paragraph 0057), wherein the second connector portion of the connector unit defines an opening to ambient air that is configured to supply air to the flow path (connector housing 2 of connector device 1 has opening to ambient air at air feeding port 4 for supplying air to the air supplying conduit 22; Figure 1; Abstract), and
wherein the NPWT device, the absorbent or non-absorbent dressing, and the tubing assembly are configured to cooperate to transfer at least a portion of wound exudate contained within the NPWT system from the absorbent or non-absorbent dressing to the canister of the NPWT device (source 23, dressing 24/27, and device 1 with conduits 21/22/7 are configured to move exudate from dressing 24/27 to canister of source 23; Abstract; Figure 1; Paragraph 0056).
Nilsson teaches the air leakage provided by the air filter may be between 10ml/min to 70 ml/min at a pressure of 120 mmHg, or between 15ml/min to 55 ml/min at a pressure of 120 mmHg (Paragraph 0057). Nilsson does not teach wherein said system comprises the flow path configured to supply air to said dressing at a rate of from 2 to 7 ml/min during operation.
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 means to supply air of a rate from 2 to 7 mL/min 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 device of Nilsson would not operate differently with the flow rate since Nilsson teaches the same components and structure as the claimed invention (see disclosed above) and is intended to deliver negative pressure and positive air to the wound dressing for wound healing. 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. 11, line 10-15). The modified Nilsson does not teach the backing layer comprising a thermoplastic elastomer, wherein said adhesive skin contact layer is a laminate comprising at least one polyurethane film and a silicone gel layer, wherein the at least one polyurethane film is positioned between the silicone gel layer and the dressing so that the silicone gel layer forms a skin contact surface of the adhesive skin contact layer and the at least one polyurethane film forms an upper surface of the laminate, and wherein the backing layer has a moisture vapor transmission rate (MVTR) in the range of from 500 to 3500 g/m2/24 h, as measured by NWSP070.4R0(15).
However, Cotton teaches the backing layer comprising a plastic elastomer (backing layer is a polyurethane film; Paragraph 0083-0084), wherein said adhesive skin contact layer is a laminate comprising at least one polyurethane film and a silicone gel layer (silicone gel skin contact layer 88 comprises a melt-blown polyurethane sheet/film that has a silicone gel coating; Paragraph 0152; Figure 11), wherein the at least one polyurethane film is positioned between the silicone gel layer and the dressing so that the silicone gel layer forms a skin contact surface of the adhesive skin contact layer and the at least one polyurethane film forms an upper surface of the laminate (polyurethane sheet is between the silicone gel and the absorbent structure 66, where the silicone gel is on the skin contact layer and the polyurethane sheet has an acrylic adhesive on its opposing side to adhere to the border 63; Figure 11; Paragraph 0152) and wherein the backing layer has a moisture vapor transmission rate (MVTR) in the range of from 500 to 3500 g/m2/24 h, as measured by NWSP070.4R0(15) (backing layer has an MVTR of at least 700 g/m2/24 h; Paragraph 0083-0084).
Nilsson and Cotton 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 Nilsson to incorporate the teachings of Cotton and have the dressing of Cotton to replace the dressing of Nilsson, with the adhesive skin contact layer laminate, as taught by Cotton and the backing layer of Cotton, wherein the backing layer and the adhesive layer of Cotton extend past the absorbent structure, as taught by Cotton. This allows for the dressing to be air and moisture vapor permeable (Cotton; Paragraph 0083), allows for the skin contact layer to be soft, tactile, conformable, and adhesive to skin (Cotton; Paragraph 0088), and allows for the border of the dressing to securely adhere to the skin of the user around the wound (Cotton; Paragraph 0086).
The combination of Nilsson in view of Cotton does not teach the backing layer comprising a thermoplastic elastomer.
However, Shulman teaches the backing layer comprising a thermoplastic elastomer (backing layer is a thermoplastic polyurethane film; Paragraph 0038).
Nilsson in view of Cotton and Shulman are both considered to be analogous to the claimed invention because they are in the same field of wound dressings. 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 Nilsson in view of Cotton to incorporate the teachings of Shulman and have the backing layer with the MVTR of Nilsson in view of Cotton to be a thermoplastic polyurethane, as taught by Shulman. This allows for the dressing to have anti-thrombogenic properties (Shulman; Paragraph 0038).
Nilsson in view of Cotton and Shulman does not teach the mobile negative pressure wound therapy (NPWT) device that is configured to be carried by a user during use.
However, Edwards teaches the mobile negative pressure wound therapy (NPWT) device that is configured to be carried by a user during use (negative-pressure devices are portable to be carried by the user during use; Paragraph 0094).
Nilsson in view of Cotton and Shulman and Edwards are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. 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 Nilsson in view of Cotton and Shulman to incorporate the teachings of Edwards and have the negative pressure wound therapy device of Nilsson in view of Cotton and Shulman to be sized to be portable, as taught by Edwards. This allows for the device to be portable to carry while being discrete and public setting (Edwards; Paragraph 0094).
Regarding claim 2, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. Nilsson teaches the air leakage provided by the air filter may be between 10ml/min to 70 ml/min at a pressure of 120 mmHg, or between 15ml/min to 55 ml/min at a pressure of 120 mmHg (Paragraph 0057). The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said flow path to supply air to said dressing is configured to supply air at a rate of from 3 to 5 ml/min.
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 means to supply air of a rate from 2 to 7 mL/min 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 tubing of Nilsson would not operate differently with the flow rate since Nilsson teaches the same components and structure as the claimed invention (see disclosed above) and is intended to deliver negative pressure and positive air to the wound dressing for wound healing. 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. 11, line 10-15).
Regarding claim 3, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. Nilsson further teaches wherein said flow path to supply air comprises an air filter arranged in said first or said second connector portion, wherein said air filter is configured to control the supply of ambient air into said dressing and/or said first tubing (air filter 5 is within the connector housing 2; Figure 1; Paragraph 0057-0058).
Regarding claim 6, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said first tubing comprises a fluid conduit configured to remove fluid from said dressing and an air conduit configured to supply air to said dressing and/or said fluid conduit (Nilsson; wound side assembly 19 has a fluid removing conduit 21 and air supplying conduit 22 to dressing 24/27; Figure 1; Abstract).
Regarding claim 10, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said dressing is absorbent (Cotton; dressing is absorbent with absorbent structure 66; Figure 11; Paragraph 0150) and said first tubing is pre-attached to said dressing (Nilsson; assembly 19 with conduits 21/22 are pre-attached to dressing 24/27; Figure 1; Abstract).
Regarding claim 11, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said dressing is absorbent (Cotton; dressing is absorbent with absorbent structure 66; Figure 11; Paragraph 0150) and wherein said dressing comprises an absorbent structure arranged between said adhesive skin contact layer and said backing layer (Cotton; absorbent structure 66 is between contact layer 88 and backing layer 61; Paragraph 0152; Figure 11), wherein said backing layer and said adhesive skin contact layer are configured to extend beyond the periphery of said absorbent structure to form a border portion along the contour of said absorbent structure (Cotton; backing layer 61 and skin contact adhesive layer 88 form a border 63 that extend past the absorbent structure 66; Paragraph 0146-0147; Figures 11-12; see rejection of claim 1 above).
Regarding claim 13, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said absorbent dressing comprises a transmission layer arranged between said adhesive skin contact layer and said absorbent structure three-dimensional textile layer 65 between adhesive skin contact layer and absorbent structure 66; Figure 11; Paragraph 0146-0148), wherein said transmission layer comprises a spacer fabric material (three-dimensional textile layer is made of spacer fabric; Paragraph 0069-0071).
Regarding claim 15, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards does not expressly teach wherein said absorbent dressing has a retention capacity of from 300 to 700 mg/cm2.
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 dressing has a retention capacity of from 300 to 700 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 dressing of Nilsson in view of Cotton, Shulman, and Edwards would not operate differently with the claimed retention capacity since Nilsson in view of Cotton, Shulman, and Edwards teaches the same dressing components and structure as the claimed invention (see disclosed above) and is intended to absorb waste from the wound while delivering negative pressure therapy. 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. 21, line 22-24).
Regarding claim 19, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein the absorbent or non-absorbent dressing is an absorbent dressing (Cotton; dressing is absorbent with absorbent structure 66; Figure 11; Paragraph 0150). The combination of Nilsson in view of Cotton, Shulman, and Edwards does not expressly teach wherein the at least a portion of the wound exudate that the NPWT device, the absorbent dressing, and the tubing assembly are configured to cooperate to transfer to the canister of the NPWT device is from 35% to 65% of the wound exudate contained within the NPWT system, and wherein the absorbent or non-absorbent dressing is configured to retain from 35% to 65 % of the wound exudate contained within the NPWT system.
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 Nilsson in view of Cotton, Shulman, and Edwards 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 the given range (specification; pg. 21, lines 29-31).
Regarding claim 20, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein the backing layer has a moisture vapor transmission rate (MVTR) in the range of from 700 to 2600 g/m2/24h as measured by NWSP070.4R0(15) (Cotton; backing layer has an MVTR of at least 700 g/m2/24 h; Paragraph 0083-0084).
Regarding claim 21, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 13. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein the at least one polyurethane film that defines the upper surface of the laminate contacts the transmission layer (Cotton; polyurethane film contacts transmission layer 65; Figure 11; Paragraph 0152).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), and Edwards et al. (Publication No. WO 2019/083726 A1), as applied to claim 3 above, and further in view of Brandolini et al. (Publication No. WO 2020/011691 A1).
Regarding claim 4, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 3. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said air filter comprises a porous material (Nilsson; Paragraph 0057-0058). The combination of Nilsson in view of Cotton, Shulman, and Edwards does not teach wherein said air filter comprises a hydrophobic material, wherein the size of the pores is within the range of from 2 to 20 pm.
However, Brandolini teaches wherein said air filter comprises a hydrophobic and porous material (filter 5525 is a microporous and hydrophobic membrane; Paragraph 0072), wherein the size of the pores is within the range of from 2 to 20 pm (filter can filter out particles from larger than 0.2 pm up to larger than 45 pm – inherent that pores must be smaller than between 0.2-45pm; Paragraph 0072). The pore range of Brandolini provides sufficient specificity since the prior art range substantially overlaps with the claimed range of the claimed invention. Brandolini also discloses that the pore size range of less than between 0.2-45pm allows for the filter to exclude microorganisms and bacteria from air passing through which reflects the same functions as the claimed invention (specification; pg. 13, lines 8-16).
Brandolini and Nilsson in view of Cotton, Shulman, and Edwards 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 Nilsson in view of Cotton, Shulman, and Edwards to incorporate the teachings of Brandolini and have the filter of Nilsson in view of Cotton, Shulman, and Edwards be the filter material of Brandolini. This allows for the filtering of microorganisms and bacteria passing through the filter (Brandolini; Paragraph 0072).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), Edwards et al. (Publication No. WO 2019/083726 A1), and Brandolini et al. (Publication No. WO 2020/011691 A1), as applied to claim 4 above, and further in view of Ishida (Patent No. US 5,403,304 A).
Regarding claim 5, Nilsson in view of Cotton, Shulman, Edwards, and Brandolini teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, Edwards, and Brandolini does not teach wherein said air filter comprises preferably sintered polyethylene.
However, Ishida teaches wherein said air filter comprises polyethylene, preferably sintered polyethylene (sintered polyethylene filter; Column 7, lines 56-61 and Column 8, lines 3-15).
Since the prior art of Ishida recognizes the equivalency of utilizing an air filter with a filter made from the material of sintered polyethylene in the field of air filters for therapy systems, it would have been obvious to a person having ordinary skill in the art to substitute the air filter of Nilsson in view of Cotton, Shulman, Edwards, and Brandolini with the sintered polyethylene material air filter of Ishida since it is recognized in the art 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 is 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, B.). In addition, Nilsson in view of Cotton, Shulman, Edwards, and Brandolini and Ishida both teach air filters that filters particles from traveling through (Ishida; Column 7, lines 56-61 and Column 8, lines 3-15; Nilsson; Paragraph 0057).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), and Edwards et al. (Publication No. WO 2019/083726 A1), as applied to claim 11 above, and further in view of Hartwell et al. (Publication No. US 2017/0143552 A1).
Regarding claim 12, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 11. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said adhesive skin contact layer comprises a plurality of apertures in the area underlying the absorbent structure (Cotton; layer 88 has apertures 89 underlying the absorbent structure 66; Figure 11; Paragraph 0152). The combination of Nilsson in view of Cotton, Shulman, and Edwards does not teach but is void of apertures in the area forming the border portion.
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 – cover layer 345 and contact layer 350 are sealed so no air travels through border 305; Figure 3A and 3B; Paragraph 0055 and 0075).
Hartwell and Nilsson in view of Cotton, Shulman, and Edwards 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 Nilsson in view of Cotton, Shulman, and Edwards to incorporate the teachings of Hartwell and have the adhesive contact layer of Nilsson in view of Cotton, Shulman, and Edwards 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; Paragraph 0075).
Claim(s) 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), and Edwards et al. (Publication No. WO 2019/083726 A1), as applied to claim 1 above, further in view of Mumby et al. (Publication No. US 2014/0249495 A1).
Regarding claim 14, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said dressing is absorbent (Cotton; dressing is absorbent with absorbent structure 66; Figure 11; Paragraph 0150), and wherein said absorbent dressing comprises an absorbent structure (Cotton; absorbent structure 66; Paragraph 0152; Figure 11). The combination of Nilsson in view of Cotton, Shulman, and Edwards does not teach a liquid spreading layer between the absorbent structure and the backing layer.
However, Mumby teaches wherein said absorbent dressing comprises a liquid spreading layer between an absorbent structure and a backing layer (masking layer 2107 is between absorbent core 2110 and cover layer 2140 and the spread of exudate is observed at masking layer; Figure 15A and 15B; Paragraph 0352 and 0375).
Nilsson in view of Cotton, Shulman, and Edwards and Mumby 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 Nilsson in view of Cotton, Shulman, and Edwards to incorporate the teachings of Mumby and have the absorbent dressing of Nilsson in view of Cotton, Shulman, and Edwards to have a liquid spreading layer of Mumby between the absorbent structure and the backing layer of Nilsson in view of Cotton, Shulman, and Edwards. This allows for the spreading of exudate across the layer to be observed (Mumby; Paragraph 0352 and 0375).
Regarding claim 16, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards further teaches wherein said backing layer comprises a coupling member configured to connect the dressing to said first tubing and wherein said backing layer comprises an opening (backing layer has a drainage port 75 that is to connected to a tubing and has an opening 76; Figure 11; Paragraph 0149-0150); said opening being arranged underneath said coupling member (opening 76 is below drainage port 75; Figure 11; Paragraph 0149). The combination of Nilsson in view of Cotton, Shulman, and Edwards does not teach wherein the dressing comprises a liquid spreading layer, wherein at least a portion of said absorbent structure comprises an opening, wherein said liquid spreading layer, if present, is void of an opening.
However, Mumby teaches wherein the dressing comprises a liquid spreading layer (masking layer 2107 is between absorbent core 2110 and cover layer 2140 and the spread of exudate is observed at masking layer; Figure 15A and 15B; Paragraph 0352 and 0375), wherein at least a portion of said absorbent structure comprises an opening (cover layer 2140 and absorbent layer 2110 has aperture 2146; Paragraph 0393; Figure 15A and 15B), wherein said liquid spreading layer, if present, is void of an opening (masking layer 2107 does not have an opening; Figure 15A and 15B).
Nilsson in view of Cotton, Shulman, and Edwards and Mumby 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 Nilsson in view of Cotton, Shulman, and Edwards to incorporate the teachings of Mumby and have the absorbent dressing of Nilsson in view of Cotton, Shulman, and Edwards to have a liquid spreading layer of Mumby between the absorbent structure and the backing layer of Nilsson in view of Cotton, Shulman, and Edwards, with the backing layer and absorbent structure of Nilsson in view of Cotton, Shulman, and Edwards, having the opening, as taught by Mumby. This allows for the spreading of exudate across the layer to be observed (Mumby; Paragraph 0352 and 0375) and allows for the negative pressure applied to the wound sight is not inhibited by the absorbent layer (Mumby; Paragraph 0393).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), Edwards et al. (Publication No. WO 2019/083726 A1), and Brandolini et al. (Publication No. WO 2020/011691 A1).
Regarding claim 17, Nilsson teaches a negative pressure wound therapy (NPWT) system (Figure 1; Abstract), the NPWT system comprising:
a wound dressing (wound cover member 24 with wound filler 27; Figure 1; Paragraph 0054-0055),
a flow path for supplying air to the wound dressing at a predetermined supply rate (flow path is air supplying conduit 22; Figure 1; Abstract), wherein the flow path for supplying air to the wound dressing comprises:
a connector unit (connector device 1 with wound side connector and connector housing 2; Figure 1; Abstract) comprising a first connector portion (wound side connector 25; Abstract; Figure 1) and a second connector portion configured to be detachably connected to said first connector portion (connector housing 2 is detachably connected to connector 25; Figure 1; Abstract), wherein the second connector portion of the connector unit defines an opening to ambient air that is configured to supply air to the flow path (connector housing 2 of connector device 1 has opening to ambient air at air feeding port 4 for supplying air to the air supplying conduit 22; Figure 1; Abstract); and
at least one tube coupled to and extending between the wound dressing and the first connector portion of the connector unit (distal end of tubing 19 is connected to first connector portion 25 and proximal end is connected to dressing 24/27; Abstract; Figure 1; Paragraph 0070), and
an NPWT device (negative pressure source 23; Figure 1; Abstract; Paragraph 0056), the NWPT device comprising:
a housing (source 23 has a housing; Figure 1; Abstract),
a negative pressure pump arranged within the housing (source 23 is a pump; Figure 1; Paragraph 0033 and 0056-0057),
a canister fluidly coupled to the negative pressure pump and to the wound dressing (source 23 has a canister; Figure 1; Paragraph 0033 and 0056-0057), and
wherein the NPWT system is configured to transfer wound exudate from the dressing to the canister of the NPWT device (source 23, dressing 24/27, and device 1 with conduits 21/22/7 are configured to move exudate from dressing 24/27 to canister of source 23; Abstract; Figure 1; Paragraph 0056).
Nilsson teaches the air leakage provided by the air filter may be between 10ml/min to 70 ml/min at a pressure of 120 mmHg, or between 15ml/min to 55 ml/min at a pressure of 120 mmHg (Paragraph 0057). Nilsson does not teach the predetermined supply rate being from 2 to 7 ml/min.
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 means to supply air of a rate from 2 to 7 mL/min 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 device of Nilsson would not operate differently with the flow rate since Nilsson teaches the same components and structure as the claimed invention (see disclosed above) and is intended to deliver negative pressure and positive air to the wound dressing for wound healing. 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. 11, line 10-15). The modified Nilsson does not teach the wound dressing provided for creating a sealed space defined in part by a wound site, the wound dressing being at least one of an absorbent or a non-absorbent dressing, the non-absorbent or absorbent dressing comprises at least a backing layer comprising a thermoplastic elastomer and an adhesive skin contact layer comprising a silicone gel, wherein said adhesive skin contact layer is a laminate comprising at least one polyurethane film and a silicone gel layer, wherein the at least one polyurethane film is positioned between the silicone gel layer and the dressing so that the silicone gel layer forms a skin contact surface of the adhesive skin contact layer and the at least one polyurethane film forms an upper surface of the laminate, and wherein the backing layer has a moisture vapor transmission rate (MVTR) in the range of from 500 to 3500 g/m2/24 h, as measured by NWSP070.4R0(15).
However, Cotton teaches the wound dressing provided for creating a sealed space defined in part by a wound site (Paragraph 0021), the wound dressing being at least one of an absorbent or a non-absorbent dressing (dressing is absorbent with absorbent structure 66; Figure 11; Paragraph 0150), the non-absorbent or absorbent dressing comprises at least a backing layer comprising a plastic elastomer (backing layer is a polyurethane film; Paragraph 0083-0084) and an adhesive skin contact layer comprising a silicone gel (silicone gel skin contact layer 88; Paragraph 0152; Figure 11), wherein said adhesive skin contact layer is a laminate comprising at least one polyurethane film and a silicone gel layer (silicone gel skin contact layer 88 comprises a melt-blown polyurethane sheet/film that has a silicone gel coating; Paragraph 0152; Figure 11), wherein the at least one polyurethane film is positioned between the silicone gel layer and the dressing so that the silicone gel layer forms a skin contact surface of the adhesive skin contact layer and the at least one polyurethane film forms an upper surface of the laminate (polyurethane sheet is between the silicone gel and the absorbent structure 66, where the silicone gel is on the skin contact layer and the polyurethane sheet has an acrylic adhesive on its opposing side to adhere to the border 63; Figure 11; Paragraph 0152), and wherein the backing layer has a moisture vapor transmission rate (MVTR) in the range of from 500 to 3500 g/m2/24 h, as measured by NWSP070.4R0(15) (backing layer has an MVTR of at least 700 g/m2/24 h; Paragraph 0083-0084).
Nilsson and Cotton 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 Nilsson to incorporate the teachings of Cotton and have the dressing of Cotton to replace the dressing of Nilsson, with the adhesive skin contact layer laminate, as taught by Cotton and the backing layer of Cotton, wherein the backing layer and the adhesive layer of Cotton extend past the absorbent structure, as taught by Cotton. This allows for the dressing to be air and moisture vapor permeable (Cotton; Paragraph 0083), allows for the skin contact layer to be soft, tactile, conformable, and adhesive to skin (Cotton; Paragraph 0088), and allows for the border of the dressing to securely adhere to the skin of the user around the wound (Cotton; Paragraph 0086).
The combination of Nilsson in view of Cotton does not teach the backing layer comprising a thermoplastic elastomer.
However, Shulman teaches the backing layer comprising a thermoplastic elastomer (backing layer is a thermoplastic polyurethane film; Paragraph 0038).
Nilsson in view of Cotton and Shulman are both considered to be analogous to the claimed invention because they are in the same field of wound dressings. 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 Nilsson in view of Cotton to incorporate the teachings of Shulman and have the backing layer with the MVTR of Nilsson in view of Cotton to be a thermoplastic polyurethane, as taught by Shulman. This allows for the dressing to have anti-thrombogenic properties (Shulman; Paragraph 0038).
Nilsson in view of Cotton and Shulman does not teach the NPWT device that is configured to be carried by a user during use.
However, Edwards teaches the NPWT device that is configured to be carried by a user during use (negative-pressure devices are portable to be carried by the user during use; Paragraph 0094).
Nilsson in view of Cotton and Shulman and Edwards are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. 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 Nilsson in view of Cotton and Shulman to incorporate the teachings of Edwards and have the negative pressure wound therapy device of Nilsson in view of Cotton and Shulman to be sized to be portable, as taught by Edwards. This allows for the device to be portable to carry while being discrete and public setting (Edwards; Paragraph 0094).
The combination of Nilsson in view of Cotton, Shulman, and Edwards does not teach a battery arranged within the housing, a control unit arranged within the housing, the control unit being electrically connected to the battery and the negative pressure pump, and wherein the control unit is arranged to:
determine an intermediate voltage level of the battery,
select a pulse width modulation (PWM) scheme for operating the negative pressure pump, the PWM scheme selected based on the predetermined supply rate, the intermediate voltage level and a predetermined level of negative pressure, wherein the predetermined level of negative pressure is from -80 to -180 mmHg, and
operate the negative pressure pump according to the selected PWM scheme.
However, Brandolini teaches a battery arranged within the housing (obvious that portable device has a battery in the housing; Paragraph 0045; Paragraph 0062 – mentions processor measuring a battery level), a control unit arranged within the housing (controller is inside of pump assembly; Paragraph 0056, 0105, and 0127), the control unit being electrically connected to the battery and the negative pressure pump (controller controls power being delivered to pump to control suction level; Paragraph 0105 and 0127), and wherein the control unit is arranged to:
determine an intermediate voltage level of the battery (voltage deliver to pump is monitored/power low; Paragraph 0050, 0077, 0127), select a pulse width modulation (PWM) scheme for operating the negative pressure pump, the PWM scheme selected based on the predetermined supply rate, the intermediate voltage level and a predetermined level of negative pressure (PWM can be selected by desired pressure level of user and monitors various conditions of pump – such as voltage, current, flow rate, and pressure; Paragraph 0058 and 0127), wherein the predetermined level of negative pressure is from -80 to -180 mmHg (therapy can be delivered between -80 and -180 mmHg; Paragraph 0046 and 0084), and
operate the negative pressure pump according to the selected PWM scheme (Paragraph 0058).
Brandolini and Nilsson in view of Cotton and Shulman and Edwards 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 Nilsson in view of Cotton and Shulman and Edwards to incorporate the teachings of Brandolini and have the battery and the control unit/controller with the functionality of Brandolini in the pump assembly of Nilsson in view of Cotton and Shulman and Edwards. This allows for the user to input the desired treatment level for operation of the therapy (Brandolini; Paragraph 0055 and 0058).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (Patent No. EP 3,320,926 A1) in view of Cotton (Publication No. US 2014/0309574 A1), Shulman et al. (Publication No. US 2019/0298578 A1), Edwards et al. (Publication No. WO 2019/083726 A1), as applied to claim 1 above, and further in view of Riesinger (Publication No. US 2016/0262942 A1).
Regarding claim 18, Nilsson in view of Cotton, Shulman, and Edwards teaches the system of claim 1. The combination of Nilsson in view of Cotton, Shulman, and Edwards does not teach wherein said NPWT system is provided as a kit of components, wherein the dressing is an absorbent dressing, and wherein said kit further comprises a second dressing that is non-absorbent.
However, Riesinger teaches wherein said NPWT system is provided as a kit of components, wherein the dressing is an absorbent dressing, and wherein said kit further comprises a second dressing that is non-absorbent (wound-care article can be dressings that are absorbent or hardly absorbent – make a kit; Paragraph 0044).
Riesinger and Nilsson in view of Cotton, Shulman, and Edwards 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 Nilsson in view of Cotton, Shulman, and Edwards to incorporate the teachings of Riesinger and have the absorbent dressing of Nilsson in view of Cotton, Shulman, and Edwards and the non-absorbent dressing of Riesinger in a kit, as taught by Riesinger. This allows for the user to select the various desired products to be placed on the wound (Riesinger; Paragraph 0044).
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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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
