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
Applicant’s amendments filed on 12/23/2025 have been fully considered. Claims 1-6 and 9-18 are pending in this application. Claims 1 and 17 are amended. Claims 7-8 are cancelled.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Regarding the argument that modifying Mumby with the teachings of Locke, Blott, and Vess would disrupt the function of the dressing of Mumby, the argument is unpersuasive. The applicant argues that the dressing of Mumby is not designed to be used for drawing fluid into a collection canister through a negative pressure pump, as seen in the claimed invention. However, as mentioned in the Non-Final Rejection mailed on 08/25/2025, Mumby states that the dressing is connectable with a pump and a canister for collecting fluid out of the dressing and into a canister (Mumby; Paragraph 0056 and 0360). Furthermore, the claim limitations of claim 1 and 17 does not require the wound dressing to allow for a liquid to travel through the dressing and into the canister, thus the dressing of Mumby that is connectable to a pump and a canister, as taught by Mumby, is sufficient to teach the claimed invention. Mumby also teaches that fluid can be removed from the dressing, wherein the fluid is interpreted to be gas/air (Paragraph 0409 and 0459; Figure 42). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the argument that none of the references teaches the claim limitation of claim 1 and 17 of “the second connector portion of the connector unit defines an opening to ambient air that is configured to provide an entry of the flow path configured to supply air”, the argument is unpersuasive. The prior art of Locke teaches a first portion of connector 150 that is connected to a delivery tube 135 and a second portion of connector 150 that is connected to the canister 140 and pump 110 (Figure 1) which is detachably connected (Mumby; Paragraph 0459 and Figure 42; see rejection below). However, the prior art of Mumby in view of Locke and Blott does not teach the second connector portion having an opening to ambient air to supply air to the device. Thus, Vess teaches a vent conduit that is connected to filter 1225 for entrance of ambient air; Figure 11A-B; Paragraph 0059. Similar to the claimed invention, the entrance of ambient air is at the opening of filter 1225 of Vess and is connected to a first portion of the filter 1225/connector, where conduit 1220 is connected (Figures 11A-11C). Since the second connector of Mumby in view of Locke and Blott is connected to supply air to the dressing while collecting fluid from the dressing, it would be obvious to one of ordinary skill in the art to include an input of a vent filter to the second connector of Mumby in view of Locke and Blott.
Regarding the amended claim language of claims 1 and 17, the amendments will be addressed in the rejection below.
Though 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.
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 Mumby et al. (Publication No. US 2014/0249495 A1) in view of Locke et al. (Publication No. US 2008/0234641 A1), Blott et al. (Publication No. US 2011/0213320 A1), and Vess et al. (Publication No. US 2010/0305524 A1).
Regarding claim 1, Mumby teaches a negative pressure wound therapy (NPWT) system (negative pressure wound treatment apparatus with wound dressing; Paragraph 0055, 0063-0070, and 0409; Figure 42) comprising
a mobile negative pressure wound therapy (NPWT) device that is configured to be carried by a user during use (portable pump unit that can be mounted on dressing; Figure 42; Paragraph 0409 and 0459), the NWPT device comprising a housing (pump 2800 has housing; Figure 42), a negative pressure pump arranged within said housing (pump 2800 is within housing; Figure 42; Paragraph 0459) and a canister detachably connected to said housing (canister can be used with a pump that is remote from the dressing – obvious that the canister can be detachably fluidly connected to housing of pump to empty canister; Paragraph 0056 and 0360),
an absorbent or non-absorbent dressing (absorbent dressing; Abstract), wherein said non-absorbent or absorbent dressing comprises at least a backing layer comprising a thermoplastic elastomer (cover layer is a thermopolyurethane film – Elastollan; Paragraph 0388; Figure 15A-B) and an adhesive skin contact layer, 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), and tubing (tubing connected to port 2150; Figure 15B; Paragraph 0055 and 0392).
Mumby does not teach a tubing assembly configured to fluidly connect said absorbent or non-absorbent dressing to said NPWT device, wherein said tubing assembly comprises:
a first connector portion;
a first tubing configured to be connected to said dressing, wherein a distal end of said first tubing is attached to the first connector portion;
a second connector portion configured to be detachably connected to said first connector portion; and
a second tubing configured to be connected to said canister, wherein a distal end of said second tubing is attached to the second connector portion, wherein the first and second connector portion cooperate to define a connector unit.
However, Locke teaches a tubing assembly configured to fluidly connect said absorbent or non-absorbent dressing to said NPWT device (tubing; Paragraph 0047; Figure 1), wherein said tubing assembly comprises:
a first connector portion (first portion of connector 150 that is connected to delivery tube 135; Figure 1; Paragraph 0050 and 0054);
a first tubing configured to be connected to said dressing (delivery tube 135 has two lumens – one lumen for delivering air to dressing and other for suction of exudate; Paragraph 0047-0048; Figure 1), wherein a distal end of said first tubing is attached to the first connector portion (distal end of delivery tube is attached to first portion of connector 150; Figure 1);
a second connector portion configured to be connected to said first connector portion (opposing portion of connector 150 is connected to first portion; Figure 1); and
a second tubing configured to be connected to said canister (tubing 130 extend between second portion of connector 150 and device’s canister; Paragraph 0047-0048; Figure 1), wherein a distal end of said second tubing is attached to the second connector portion (distal end of tubing 130 is attached to opposing portion of connector 150; Figure 1), wherein the first and second connector portion cooperate to define a connector unit (connector 150 has first and second connector portion; Figure 1).
Locke 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 Mumby to incorporate the teachings of Locke and have the tubing, first, and second connector portions of Locke to replace the tubing of Mumby. This allows for the simplified use of the reduced pressure therapy system for the user and lessens the burden of carrying (Locke; Paragraph 0077).
The combination of Mumby in view of Locke does not teach the second connector portion and the first connector portion are detachably connected.
However, Mumby further teaches the second connector portion and the first connector portion are detachably connected (connector 2221 has first and second connector portions; Paragraph 0459; Figure 42).
Mumby 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 (connector of Locke) for another (detachable connector of Mumby) 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).
The combination of Mumby in view of Locke does not teach wherein said system comprises a flow path configured to supply air to said dressing at a rate of from 2 to 7 ml/min during operation.
However, Blott teaches the flow path configured to supply air to said dressing at a rate of from 2 to 7 ml/min during operation (fluid volume flow rate or irrigant is in the range of 1 to 1500 ml/hr or 0.02 to 25 ml/min, where the irrigant fluid can be a gas; Paragraph 0084, 0133, and 0143).
Mumby in view of Locke and Blott 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 Mumby in view of Locke to incorporate the teachings of Blott and have the tubing of Mumby in view of Locke to have the flow rate of Blott. This allows for the optimum performance of wound healing by the delivery of irrigant (Blott; Paragraph 0133).
Additionally, 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 Mumby in view of Locke would not operate differently with the flow rate since Mumby in view of Locke 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 combination of Mumby in view of Locke and Blott does not teach 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.
However, Vess teaches 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 (the top portion/second connector portion of vent filter 1225 has an opening to allow for ambient air to enter and supply air to the flow path and the bottom portion/first connector portion of vent filter 1225 to connect to a first tubing 1220; Figure 11A-B; Paragraph 0059). Vess further teaches that individual fluid and vent conduits can be a conduit with a dual lumen (Paragraph 0060).
Mumby in view of Locke and Blott and Vess 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 Mumby in view of Locke and Blott to incorporate the teachings of Vess and have the second connector of Mumby in view of Locke and Blott to have the top portion of the vent filter of Vess, the first connector of Mumby in view of Locke and Blott to have the bottom portion of the vent filter of Vess, and the first tubing to be coaxial and have the conduit of Vess to allow for the entrance of ambient air into the dressing. This allows for continuous fluid flow through the negative pressure conduit with the continuous positive pressure of the filtered ambient air (Vess; Paragraph 0059-0060).
Regarding claim 2, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess 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 (Blott; fluid volume flow rate or irrigant is in the range of 1 to 1500 ml/hr or 0.02 to 25 ml/min – 3 to 5 mL/min is within the range, where the irrigant fluid can be a gas; Paragraph 0084, 0133, and 0143; see rejection of claim 1 above).
Additionally, 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 Mumby in view of Locke would not operate differently with the flow rate since Mumby in view of Locke 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, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess 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 (Vess; vent conduit is connected to a filter 1225 that allows for the entrance of filtered ambient air – controls the contents that enter into the dressing; Figure 11A-B; Paragraph 0008 and 0059).
Regarding claim 6, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess 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 (delivery tube has two lumens – one lumen for suction of exudate and the other lumen for delivering air to the dressing; Paragraph 0047-0048; Figure 1).
Regarding claim 9, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. 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) (outer cover has MVTR of 500-2000 g/m2/24hrs; Paragraph 0260).
Regarding claim 10, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess further teaches wherein said dressing is absorbent (Mumby; wound dressing 2100 is absorbent; Figures 15A-15B; Paragraph 0368-0369) and said first tubing is pre-attached to said dressing (Locke; delivery tubing 135 – obvious that tubing is pre-attached to dressing before use; Figure 1).
Regarding claim 11, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. Mumby further teaches wherein said dressing is absorbent (Mumby; wound dressing 2100 is absorbent; Paragraph 0055, 0368, and 0394; Figure 15A and 15B) and comprises a backing layer (Mumby; cover layer 2140; Paragraph 0368 and 0394; Figure 15A and 15B), an adhesive skin contact layer (Mumby; wound contact layer 2102 with adhesive on underside surface 2101; Paragraph 0368; Figure 15A and 15B) and an absorbent structure arranged between said adhesive skin contact layer and said backing layer (Mumby; layer 2110 between cover layer 2140 and wound contact layer 2102; Paragraph 0375; Figure 15A and 15B), 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).
Regarding claim 13, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. Mumby further 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).
Regarding claim 14, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. Mumby further 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 0323 and 0375).
Regarding claim 15, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess 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 , Mumby in view of Locke, Blott, and Vess would not operate differently with the claimed retention capacity since , Mumby in view of Locke, Blott, and Vess 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 and positive air therapy (Locke; Abstract). 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, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. Mumby further teaches wherein the dressing comprises a backing layer (Mumby; cover layer 2140; Figure 15A and 15B; Paragraph 0323 and 0375) and 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 0323 and 0375), wherein said backing layer comprises a coupling member (Mumby; port 2150 on cover layer 2140; Paragraph 0375 and 0385; Paragraph 15A and 15B) configured to connect the dressing to said first tubing (Mumby; configured to connect to tubing; Paragraph 0055 and 0392) and wherein said backing layer and at least a portion of said absorbent structure comprises an opening (Mumby; cover layer 2140 and absorbent layer 2110 has aperture 2146; Paragraph 0393; Figure 15A and 15B); said opening being arranged underneath said coupling member (Mumby; aperture 2146 is under port 2150; Figure 15A and 15B), wherein said liquid spreading layer, if present, is void of an opening (Mumby; masking layer 2107 does not have an opening; Figure 15A and 15B).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mumby et al. (Publication No. US 2014/0249495 A1) in view of Locke et al. (Publication No. US 2008/0234641 A1), Blott et al. (Publication No. US 2011/0213320 A1), and Vess et al. (Publication No. US 2010/0305524 A1), as applied to claim 3 above, and further in view of Brandolini et al. (Publication No. WO 2020/011691 A1).
Regarding claim 4, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess further teaches wherein said air filter comprises a hydrophobic material (Vess; Paragraph 0008). The combination of Mumby in view of Locke, Blott, and Vess wherein said air filter comprises a porous 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 Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess to incorporate the teachings of Brandolini and have the filter of Mumby in view of Locke, Blott, and Vess 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 Mumby et al. (Publication No. US 2014/0249495 A1) in view of Locke et al. (Publication No. US 2008/0234641 A1), Blott et al. (Publication No. US 2011/0213320 A1), and Vess et al. (Publication No. US 2010/0305524 A1), as applied to claim 3 above, and further in view of Ishida (Patent No. US 5,403,304 A).
Regarding claim 5, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess 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, Mumby in view of Locke, Blott, and Vess and Ishida both teach air filters that filters microorganisms from traveling through (Ishida; Column 7, lines 56-61 and Column 8, lines 3-15; Vess; Paragraph 0008).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mumby et al. (Publication No. US 2014/0249495 A1) in view of Locke et al. (Publication No. US 2008/0234641 A1), Blott et al. (Publication No. US 2011/0213320 A1), and Vess et al. (Publication No. US 2010/0305524 A1), as applied to claim 11 above, and further in view of Hartwell et al. (Publication No. US 2017/0143552 A1).
Regarding claim 12, Mumby in view of Locke, Blott, and Vess teaches the system of claim 11. 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 Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess to incorporate the teachings of Hartwell and have the adhesive contact layer of Mumby in view of Locke, Blott, and Vess 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 Mumby et al. (Publication No. US 2014/0249495 A1) in view of Locke et al. (Publication No. US 2008/0234641 A1), Blott et al. (Publication No. US 2011/0213320 A1), Vess et al. (Publication No. US 2010/0305524 A1), and Brandolini et al. (Publication No. WO 2020/011691 A1).
Regarding claim 17, Mumby teaches a negative pressure wound therapy (NPWT) system (negative pressure wound treatment apparatus with wound dressing; Paragraph 0055, 0063-0070, and 0409; Figure 42), the NPWT system comprising:
a wound dressing (absorbent dressing; Abstract), the wound dressing provided for creating a sealed space defined in part by a wound site (Paragraph 0089), the wound dressing being at least one of an absorbent or a non- absorbent dressing (absorbent dressing; Abstract), the non-absorbent or absorbent dressing comprises at least a backing layer comprising a thermoplastic elastomer (cover layer is a thermopolyurethane film – Elastollan; Paragraph 0388; Figure 15A-B) and an 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 – obvious that silicone adhesive is in gel form; Paragraph 0368; Figure 15A-B), tubing (tubing connected to port 2150; Figure 15B; Paragraph 0055 and 0392),
an NPWT device that is configured to be carried by a user during use (portable pump unit that can be mounted on dressing; Figure 42; Paragraph 0409 and 0459), the NWPT device comprising:
a housing (pump 2800 has housing; Figure 42),
a battery arranged within the housing (Paragraph 0361),
a negative pressure pump arranged within the housing (pump 2800 is within housing; Figure 42; Paragraph 0459),
a canister fluidly coupled to the negative pressure pump and to the wound dressing (canister can be used with a pump that is remote from dressing and canister is fluidly connected to the dressing – obvious that the canister can be detachably fluidly connected to housing of pump to empty canister; Paragraph 0056 and 0360).
Mumby does not teach a flow path for supplying air to the wound dressing, wherein the flow path for supplying air to the wound dressing comprises:
a connector unit comprising a first connector portion and a second connector portion configured to be connected to said first connector portion, and
at least one tube coupled to and extending between the wound dressing and the first connector portion of the connector unit.
However, Locke teaches a flow path for supplying air to the wound dressing (tubing; Paragraph 0047; Figure 1), wherein the flow path for supplying air to the wound dressing comprises:
a connector unit comprising a first connector portion and a second connector portion configured to be detachably connected to said first connector portion (connector 150 has first and second connector portion on opposing ends and connected to each other; Figure 1) and
at least one tube coupled to and extending between the wound dressing and the first connector portion of the connector unit (delivery tube 135 has two lumens – one lumen for delivering air to dressing and other for suction of exudate that is connected between connector 150 and dressing; Paragraph 0047-0048; Figure 1).
Locke 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 Mumby to incorporate the teachings of Locke and have the tubing, first, and second connector portions of Locke to replace the tubing of Mumby. This allows for the simplified use of the reduced pressure therapy system for the user and lessens the burden of carrying (Locke; Paragraph 0077).
The combination of Mumby in view of Locke does not teach the second connector portion and the first connector portion are detachably connected.
However, Mumby further teaches the second connector portion and the first connector portion are detachably connected (connector 2221 has first and second connector portions; Paragraph 0459; Figure 42).
Mumby 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 (connector of Locke) for another (detachable connector of Mumby) 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).
The combination of Mumby in view of Locke does not teach the flow path for supplying air to the wound dressing at a predetermined supply rate, the rate being from 2 to 7 ml/min.
However, Blott teaches the flow path configured to supply air to said dressing at a rate of from 2 to 7 ml/min during operation (fluid volume flow rate or irrigant is in the range of 1 to 1500 ml/hr or 0.02 to 25 ml/min, where the irrigant fluid can be a gas; Paragraph 0084, 0133, and 0143).
Mumby in view of Locke and Blott 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 Mumby in view of Locke to incorporate the teachings of Blott and have the tubing of Mumby in view of Locke to have the flow rate of Blott. This allows for the optimum performance of wound healing by the delivery of irrigant (Blott; Paragraph 0133).
Additionally, 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 Mumby in view of Locke would not operate differently with the flow rate since Mumby in view of Locke 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 combination of Mumby in view of Locke and Blott does not teach 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.
However, Vess teaches 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 (the top portion/second connector portion of vent filter 1225 has an opening to allow for ambient air to enter and supply air to the flow path and the bottom portion/first connector portion of vent filter 1225 to connect to a first tubing 1220; Figure 11A-B; Paragraph 0059). Vess further teaches that individual fluid and vent conduits can be a conduit with a dual lumen (Paragraph 0060).
Mumby in view of Locke and Blott and Vess 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 Mumby in view of Locke and Blott to incorporate the teachings of Vess and have the second connector of Mumby in view of Locke and Blott to have the top portion of the vent filter of Vess, the first connector of Mumby in view of Locke and Blott to have the bottom portion of the vent filter of Vess, and the first tubing to be coaxial and have the conduit of Vess to allow for the entrance of ambient air into the dressing. This allows for continuous fluid flow through the negative pressure conduit with the continuous positive pressure of the filtered ambient air (Vess; Paragraph 0059-0060).
The combination of Mumby in view of Locke, Blott, and Vess does not teach 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 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 Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess to incorporate the teachings of Brandolini and have the control unit/controller with the functionality of Brandolini in the pump assembly of Mumby in view of Locke, Blott, and Vess. 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 Mumby et al. (Publication No. US 2014/0249495 A1) in view of Locke et al. (Publication No. US 2008/0234641 A1), Blott et al. (Publication No. US 2011/0213320 A1), and Vess et al. (Publication No. US 2010/0305524 A1), as applied to claim 1 above, and further in view of Riesinger (Publication No. US 2016/0262942 A1).
Regarding claim 18, Mumby in view of Locke, Blott, and Vess teaches the system of claim 1. The combination of Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess 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 Mumby in view of Locke, Blott, and Vess to incorporate the teachings of Riesinger and have the absorbent dressing of Mumby in view of Locke, Blott, and Vess 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
/KAI H WENG/Primary Examiner, Art Unit 3781