DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/01/2026 has been entered.
Response to Amendment
The amendments filed on 06/01/2026 has been entered. Claims 1-6 and 9-18 are pending in this application. Claims 1 and 17 are amended.
Response to Arguments
Applicant’s arguments with respect to claim(s) 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 required a change in the grounds of rejection as detailed below in the prior art rejection. More specifically, the amended claim limitation “wherein the NPWT device, the absorbent or non-absorbent dressing, and the tubing assembly are configured to cooperate to transfer wound exudate from the absorbent or non-absorbent dressing to the canister of the NPWT device” of claim 1 and “wherein the NPWT system is configured to transfer wound exudate from the dressing to the canister of the NPWT device” of claim 17 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 11-14, 16, and 18 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.
Regarding claim 11, the claim recites “a backing layer” at line 2 and “an adhesive skin contact layer” at line 2. It is unclear if “a backing layer” of claim 11, line 2 is the same backing layer as “a backing layer of claim 1, line 6 and if “an adhesive skin contact layer” of claim 11, line 2 is the same adhesive skin contact layer of claim 1, lines 6-7. For the purposes of examination, “a backing layer” and “an adhesive skin contact layer” of claim 11 will be interpreted to be the same components of “a backing layer” and “an adhesive layer” of claim 1.
Regarding claim 14, the claim recites “a backing layer” at line 3. It is unclear if “a backing layer” of claim 14, line 3 is the same backing layer as “a backing layer of claim 1, line 6. For the purposes of examination, “a backing layer” of claim 14 will be interpreted to be the same components of “a backing layer” of claim 1.
Regarding claim 16, the claim recites “a backing layer” at line 3. It is unclear if “a backing layer” of claim 16, line 2 is the same backing layer as “a backing layer of claim 1, line 6. For the purposes of examination, “a backing layer” of claim 16 will be interpreted to be the same components of “a backing layer” of claim 1.
Regarding claim 16, the claim recites “said absorbent structure” limitation in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the claim recites “a non-absorbent and an absorbent dressing” limitation in lines 2-3. It is unclear if “a non-absorbent and an absorbent dressing” of claim 18 is the same component of “an absorbent or non-absorbent dressing” of claim 1, line 5. For the purposes of examination, “a non-absorbent and an absorbent dressing” of claim 18 is interpreted to be the same components of “an absorbent or non-absorbent dressing” of claim 1.
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, 9-11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (EP 3,320,926 A1) in view of Mumby et al. (Publication No. US 2014/0249495 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 wound exudate 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 mobile negative pressure wound therapy (NPWT) device that is configured to be carried by a user during use, 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.
However, Mumby teaches the mobile negative pressure wound therapy (NPWT) device that is configured to be carried by a user during use (portable pump unit that can be carried by user; Figure 42; Paragraph 0409 and 0459), the backing layer comprising a thermoplastic elastomer (cover layer is a thermopolyurethane film – Elastollan; Paragraph 0388; Figure 15A-B), wherein said adhesive skin contact layer is a laminate comprising at least one polyurethane film and a silicone gel layer (wound contact layer 2102 is a laminate that has polyurethane layer and silicone pressure sensitive adhesive – implicit that silicone adhesive is in gel form; Paragraph 0368; Figure 15A-B).
Nilsson 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 to incorporate the teachings of Mumby and have the negative pressure source of Nilsson to be portable sized, as taught by Mumby, and have the backing layer/wound cover of Nilsson to be made and shaped of a thermoplastic elastomer of Mumby and have the adhesive layer of Mumby under the wound filler and wound cover of Nilsson to connect the backing layer with the adhesive layer. This allows for the device to be compact/miniaturized for carrying (Mumby; Paragraph 0459), allows for the top film to encapsulate the layers below the cover/provide breathability (Mumby; Paragraph 0258-259), and to adhere the wound dressing onto the skin for an airtight seal for negative pressure treatment (Mumby; Paragraph 0368).
Regarding claim 2, Nilsson in view of Mumby 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 Mumby 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 Mumby 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 Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby 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 9, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby further teaches wherein the backing layer has a moisture vapor transmission rate (MVTR) in the range of from 500 to 3500 g/m2/24h, as measured by NWSP070.4R0(15) (Mumby; outer cover has MVTR of 500-2000 g/m2/24hrs; Paragraph 0260).
Regarding claim 10, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby further teaches wherein said dressing is absorbent and said first tubing is pre-attached to said dressing (Nilsson; dressing 24/27 is absorbent because of the wound filler 27 and assembly 19 with conduits 21/22 are pre-attached to dressing 24/27; Figure 1; Abstract).
Regarding claim 11, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby further teaches wherein said dressing is absorbent (Nilsson; wound cover member 24 with wound filler 27 is absorbent; Figure 1; Paragraph 0054-0055) and comprises a backing layer (Nilsson; wound cover member 24; Figure 1; Paragraph 0054-0055; Mumby; cover layer is a thermopolyurethane film – Elastollan; Paragraph 0388; Figure 15A-B; see rejection of claim 1 above), an adhesive skin contact layer (Mumby; wound contact layer 2102 is a laminate that has polyurethane layer and silicone pressure sensitive adhesive – implicit that silicone adhesive is in gel form; Paragraph 0368; Figure 15A-B; see rejection of claim 1 above) and an absorbent structure arranged between said adhesive skin contact layer and said backing layer (Nilsson; wound filler 27; Figure 1; Abstract; absorbent structure of Nilsson between adhesive skin contact layer of Mumby and backing layer of Nilsson in view of Mumby; see rejection of claim 1 above), 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 (Mumby; cover layer 2140 is sealing to wound contact layer 2102 to form border region 2200 around dressing; Paragraph 0388; Figure 15A and 15B; see rejection of claim 1 above).
Regarding claim 13, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby does not teach wherein said absorbent dressing comprises a transmission layer arranged between said adhesive skin contact layer and said absorbent structure, wherein said transmission layer comprises a spacer fabric material.
However, Mumby teaches wherein said absorbent dressing comprises a transmission layer arranged between said adhesive skin contact layer and said absorbent structure (transmission layer 2105 is between absorbent layer 2110 and skin contact layer 2102; Paragraph 0369; Figure 15A and 15B), wherein said transmission layer comprises a spacer fabric material (layer 2105 is made of spacer fabric; Paragraph 0369).
Nilsson 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 Mumby to incorporate the teachings of Mumby and have the absorbent dressing of Nilsson in view of Mumby to have a transmission layer of Mumby between the adhesive layer and the absorbent structure of Nilsson in view of Mumby. This allows for the transmission of fluid away from the wound site into the upper layers of the dressing (Mumby; Paragraph 0369).
Regarding claim 14, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby does not teach wherein said absorbent dressing comprises a liquid spreading layer between an absorbent structure and a 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 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 Mumby to incorporate the teachings of Mumby and have the absorbent dressing of Nilsson in view of Mumby to have a liquid spreading layer of Mumby between the absorbent structure and the backing layer of Nilsson in view of Mumby. This allows for the spreading of exudate across the layer to be observed (Mumby; Paragraph 0352 and 0375).
Regarding claim 15, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby 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 Mumby would not operate differently with the claimed retention capacity since Nilsson in view of Mumby 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 16, Nilsson in view of Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby teaches wherein the dressing comprises a backing layer (Nilsson; wound cover member 24; Figure 1; Paragraph 0054-0055; Mumby; cover layer is a thermopolyurethane film – Elastollan; Paragraph 0388; Figure 15A-B; see rejection of claim 1 above), wherein said backing layer comprises a coupling member configured to connect the dressing to said first tubing (suction interface 20 on backing layer 24 to connect dressing 24/27 to the wound side assembly 19; Figure 1; Paragraph 0056). The combination of Nilsson in view of Mumby does not teach wherein the dressing comprises a liquid spreading layer, wherein said backing layer and at least a portion of said absorbent structure comprises an opening; said opening being arranged underneath said coupling member, 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 said backing layer and 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); said opening being arranged underneath said coupling member (aperture 2146 is under port 2150; 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 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 Mumby to incorporate the teachings of Mumby and have the absorbent dressing of Nilsson in view of Mumby to have a liquid spreading layer of Mumby between the absorbent structure and the backing layer of Nilsson in view of Mumby, with the backing layer and absorbent structure of Nilsson in view of Mumby, 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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (EP 3,320,926 A1) in view of Mumby et al. (Publication No. US 2014/0249495 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 Mumby teaches the system of claim 3. The combination of Nilsson in view of Mumby further teaches wherein said air filter comprises a porous material (Nilsson; Paragraph 0057-0058). The combination of Nilsson in view of Mumby 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 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 Mumby to incorporate the teachings of Brandolini and have the filter of Nilsson in view of Mumby 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. (EP 3,320,926 A1) in view of Mumby et al. (Publication No. US 2014/0249495 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 Mumby and Brandolini teaches the system of claim 1. The combination of Nilsson in view of Mumby 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 Mumby 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 Mumby 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. (EP 3,320,926 A1) in view of Mumby et al. (Publication No. US 2014/0249495 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 Mumby teaches the system of claim 11. The combination of Nilsson in view of Mumby further teaches wherein said adhesive skin contact layer comprises a plurality of apertures in the area underlying the absorbent structure (Mumby; wound contact layer 2102 has perforations 2104; Paragraph 0368). The combination of Nilsson in view of Mumby 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 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 Mumby to incorporate the teachings of Hartwell and have the adhesive contact layer of Nilsson in view of Mumby 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) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsson et al. (EP 3,320,926 A1) in view of Mumby et al. (Publication No. US 2014/0249495 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), the wound dressing provided for creating a sealed space defined in part by a wound site (dressing 24/27 is to create a sealed space for wound 9 to be treated with NPWT; Paragraph 0054; Figure 1; Abstract), the wound dressing being at least one of an absorbent or a non-absorbent dressing (wound cover member 24 with wound filler 27 is absorbent; Figure 1; Paragraph 0054-0055), the 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),
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), and
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 does not teach the backing layer comprising a thermoplastic elastomer, the 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, the NPWT device that is configured to be carried by a user during use, the NPWT device comprising: a battery arranged within the housing.
However, Mumby teaches the backing layer comprising a thermoplastic elastomer (cover layer is a thermopolyurethane film – Elastollan; Paragraph 0388; Figure 15A-B), the adhesive skin contact layer comprising a silicone gel (wound contact layer 2102 is a laminate that has polyurethane layer and silicone pressure sensitive adhesive – implicit that silicone adhesive is in gel form; Paragraph 0368; Figure 15A-B), wherein said adhesive skin contact layer is a laminate comprising at least one polyurethane film and a silicone gel layer (wound contact layer 2102 is a laminate that has polyurethane layer and silicone pressure sensitive adhesive – implicit that silicone adhesive is in gel form; Paragraph 0368; Figure 15A-B), the NPWT device that is configured to be carried by a user during use (portable pump unit that can be carried by user; Figure 42; Paragraph 0409 and 0459), the NPWT device comprising: a battery arranged within the housing (portable pump 2800 has battery in housing; Figure 42; Paragraph 0361 and 0459).
Nilsson 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 to incorporate the teachings of Mumby and have the negative pressure source of Nilsson to be portable sized, as taught by Mumby, and have the backing layer/wound cover of Nilsson to be made and shaped of a thermoplastic elastomer of Mumby and have the adhesive layer of Mumby under the wound filler and wound cover of Nilsson to connect the backing layer with the adhesive layer. This allows for the device to be compact/miniaturized for carrying (Mumby; Paragraph 0459), allows for the top film to encapsulate the layers below the cover/provide breathability (Mumby; Paragraph 0258-259), and to adhere the wound dressing onto the skin for an airtight seal for negative pressure treatment (Mumby; Paragraph 0368).
The combination of Nilsson in view of Mumy does not teach a control unit arranged within the housing, the control unit being electrically connected to the battery and the negative pressure pump, 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 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), 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 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 Mumby to incorporate the teachings of Brandolini and have the control unit/controller with the functionality of Brandolini in the pump assembly of Nilsson in view of Mumby. 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. (EP 3,320,926 A1) in view of Mumby et al. (Publication No. US 2014/0249495 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 Mumby teaches the system of claim 1. The combination of Nilsson in view of Mumby does not teach wherein said NPWT system is provided as a kit of components and wherein said kit comprises both a non-absorbent and an absorbent dressing.
However, Riesinger teaches wherein said NPWT system is provided as a kit of components and wherein said kit comprises both a non-absorbent and an absorbent dressing (wound-care article can be dressings that are absorbent or hardly absorbent – make a kit; Paragraph 0044).
Riesinger and Nilsson in view of 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 Mumby to incorporate the teachings of Riesinger and have the absorbent dressing of Nilsson in view of Mumby 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
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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