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 .
Status of Claims
Claims 1 and 3-21 are currently pending. Claims 1, 8, 13, 15-17, and 20 are currently amended. Claim 21 is newly added. No new subject matter is added.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Specifically, Applicant argues in Claim 1 that Braga fails to teach using the door to substantially cover the rear surface of the canister and maintain the front surface of the canister against the canister connecting surface such that canister is disposed between the door and canister connecting surface of the pump unit. Applicant further states that it would be impossible to modify Cowart to include a door as in claim 1 that positioned the canister between the door and the canister connecting surface.
The examiner respectfully disagrees that Cowart in view of Braga would not teach using the door to substantially cover the rear surface of the canister and maintain the front surface of the canister against the canister connecting surface such that canister is disposed between the door and canister connecting surface of the pump unit. The rear surface of the canister can be interpreted to be the surface contacting the pump unit (canister connection wall 82). The front surface of the canister can be the exterior surface adjacent to second end (83). Therefore, the door can be located similarly to the engagement mechanisms (75 and 85, see Figure 8B) such that canister is disposed between the door and canister connecting surface of the pump unit. Therefore, Cowart and Braga would still read on claim 1.
Specifically, Applicant argues in Claim 13 that Cowart would fail to read on a canister having a canister outlet and a canister inlet in the rear surface of the canister that is disposed against the canister connection surface when the canister is fluidly connected to the pump unit. The examiner respectfully disagrees that Cowart fails to teach a canister having a canister outlet and a canister inlet in the rear surface of the canister that is disposed against the canister connection surface when the canister is fluidly connected to the pump unit. As, discussed below, Cowart teaches a rear surface of the canister (inner surface of canister connection wall 82 at the first end 81, see Figure 6), the rear surface including a canister outlet (an aperture 88 of surface 82, Figure 6) positioned and configured to be fluidly connected to the pump inlet for fluidly connecting the canister to the pump unit (pump inlet port 58 in fluid communication with the pump inlet 13, see Paragraph [0032]; and aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58 when the canister 18 is fluidly connected to the vacuum pump unit 14, see Paragraph [0035]). Therefore, Cowart would still read on the limitations of the claim.
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.
Claims 1, 3-4, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cowart et al. (US 20210275732 A1), hereinafter referred to as “Cowart” in view of Locke et al. (US 20140276488 A1), hereinafter referred to as “Locke”, and in further view of Braga et al. (US 20090240218 A1), hereinafter referred to as “Braga”.
Regarding Claim 1, Cowart teaches a disposable NPWT system for providing reduced pressure along a fluid flow path to a wound site (NPWT system 10 with disposable canister 18 for providing reduce pressure along a fluid flow path to a wound site, see Figure 1, Paragraph [0028]), the disposable NPWT system comprising:
a pump unit (primary pressure source 14) having a canister connecting surface (pump connection wall 52, see Figures 4-5), the canister connecting surface including:
a first canister engagement mechanism (engaging mechanism 75),
a second canister engagement mechanism (engaging mechanism 73), and
a pump inlet (pump inlet 13, see Paragraph [0032]) disposed between the first canister engagement mechanism and the second canister engagement mechanism (pump inlet aligned with inlet port 58 on surface 52 between engaging mechanisms 73 and 75, see Figure 1 and 5);
a canister dimensioned and configured for collecting extracted exudate from a wound site (canister 18 to collect wound exudate, see Paragraph [0028]), the canister having a front surface (exterior surface adjacent to second end 83) and a rear surface (inner surface of canister connection wall 82 at the first end 81, see Figure 6), the rear surface including a canister outlet (an aperture 88 of surface 82, Figure 6) positioned and configured to be fluidly connected to the pump inlet for fluidly connecting the canister to the pump unit (pump inlet port 58 in fluid communication with the pump inlet 13, see Paragraph [0032]; and aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58 when the canister 18 is fluidly connected to the vacuum pump unit 14, see Paragraph [0035]); and aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58, see Paragraph [0035]; Figures 4-7);
a canister adapter for securing the canister to the pump unit such that the canister outlet is fluidly connected to the pump inlet (a canister plate that includes the canister connecting wall 82 with extending flange 94 containing the slot 83 within one portion of the flange 94 and the depressible latch 85 extending from one portion of the flange 94 generally opposite the slot 83, see Paragraph [0043]; allowing for aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58, see Paragraph [0035]; Figures 4-7) and the rear surface of the canister (canister connection wall 82 of pump 18) is positioned along the canister connecting surface of the pump unit (along pump connection wall 52, see Figures 4, 6, and 8A), the canister adapter including:
a first pump engagement mechanism (latch 85) positioned and configured to removably engage the first canister engagement mechanism (second engaging mechanism 85 positioned and configured to engage the second engaging mechanism 75, see Paragraph [0036]; Figure 8B-C),
a second pump engagement mechanism (clip receiver/slot 83) positioned and configured to removably engage the second canister engagement mechanism (engaging mechanism 83 disposed adjacent the first side 84 of canister connection wall 82 that is positioned and configured to engage the first engaging mechanism 73, see Paragraph [0036]; Figure 8A), and
an aperture (inlet port 58) disposed between the first pump engagement mechanism and the second pump engagement mechanism (see Figure 7), the aperture (inlet port 58) being positioned and configured such that the canister outlet (88) is fluidly connected to the pump inlet (13) through the aperture when the canister is fluidly connected to the pump unit (pump inlet port 58 in fluid communication with the pump inlet 13, see Paragraph [0032]; and aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58 when the canister 18 is fluidly connected to the vacuum pump unit 14, see Paragraph [0035]); and
However, Cowart does not explicitly disclose a canister formed of a soft material and the canister adapter formed of a more rigid material as compared to the soft material of the canister.
Locke teaches a wound fluid collection system includes a canister (see Abstract; Figures 1-2) wherein the canister is formed of a soft material (canister 102 having a flexible container 104, see Figure 1 and 2) and a canister adapter formed of a more rigid material as compared to the soft material of the canister (carrier plate 103 of the canister 102 is a thermoplastic plate that supports the container 104, see Paragraph [0021]; Figure 2; it is understood that the carrier plate is made of a more rigid material to support container 104).
Cowart and Locke art analogous art because both disclose a NPWT system for providing reduced pressure along a fluid flow path to a wound site comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister and adaptor and Cowart and further include wherein the canister is formed of a soft material and the canister adapter formed of a more rigid material as compared to the soft material of the canister, as taught by Locke. Locke teaches its beneficial for a canister having a variable volume from a first volume to a second volume, the second volume being greater than the first volume; while affixing the canister to a carrier plate, whereby the volume of the canister is maintained substantially at the second volume (see Paragraph [0028]).
Cowart and Locke teaches all of the limitations as discussed above. However, Cowart and Locke does not explicitly disclosed a door operatively connected to the pump unit for substantially covering the front surface of the canister and maintaining the positioning of the rear surface of the canister along the connecting surface of the pump unit when the door is in a closed position such that the canister is disposed between the canister connecting surface and the door.
Braga teaches a NPWT system (see Abstract; Figure 1-2A and 17) comprising a canister (14) comprising a door operatively connected to the pump unit for substantially covering the front surface of the canister (door 657 connected to housing 120 on a front surface of the canister, see Paragraph [0085]; Figure 17) and maintaining the positioning of the rear surface of the canister along the connecting surface of the pump unit when the door is in a closed position such that the canister is disposed between the canister connecting surface and the door (once placed together door 657 is closed and locked in place to securely engage canister 118 with housing 120, see Paragraph [0085]).
Cowart, Locke, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister and pump unit of Modified Cowart and further include a door operatively connected to the pump unit, as taught by Braga. Braga teaches it would be advantageous to provide a user friendly mechanism for connecting and disconnecting components of the system (see Paragraph [0007]).
Regarding Claim 3, Modified Cowart teaches all of the limitations of claim 1 and Cowart further teaches wherein:
the first pump engagement mechanism includes a deflectable tab (latch 85 having a tab 92, see Figure 8B-C),
the first canister engagement mechanism (75) includes a first tab receiver (opening 76) and a locking surface disposed adjacent the first tab receiver (tip of the engagement mechanism 75), and
the deflectable tab of the first pump engagement mechanism is configured to deflect inward as it traverses the locking surface of the first canister engagement mechanism (the tab 92 is able to gradually flex inward until the tab 92 reaches the opening 76 of the latch receptacle 75, see Paragraph 0085]) and then deflect outward as the deflectable tab passes the locking surface to fluidly connect the canister to the pump unit (once the tab 92 reaches the opening 76 of the latch receptacle 75, the depressible latch 85 snaps back towards its resting position, see Paragraph [0038]).
Regarding Claim 4, Cowart and Locke teach all of the limitations of claim 1. However, Cowart and Locke do not explicitly disclose wherein the second pump engagement mechanism includes an alignment tab, and the second canister engagement mechanism includes a second tab receiver dimensioned and configured to receive the alignment tab when the second pump engagement mechanism engages the second canister engagement mechanism.
Braga teaches a NPWT system (see Abstract) comprising a pump unit (control unit 256) having a canister connecting surface, the canister connecting surface (lower connecting surface of 256 for connecting to canister 258, see Figure 3A) including a second canister engagement mechanism (tab 260); a second pump engagement mechanism (262); wherein the second pump engagement mechanism includes an alignment tab (tab 260), and the second canister engagement mechanism includes a second tab receiver (262) dimensioned and configured to receive the alignment tab when the second pump engagement mechanism engages the second canister engagement mechanism (tab 260 is received in slot 262, see Figure 4A; Paragraph [0064]).
Cowart, Locke, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the second pump engagement and second canister engagement mechanism of Modified Cowart and replace it with the second pump engagement mechanism including an alignment tab, and the second canister engagement mechanism including a second tab receiver configured to receive the alignment tab when the second pump engagement mechanism engages the second canister engagement mechanism, as taught by Braga. Braga teaches the various components of the wound therapy system may need to be disconnected or be replaced for a variety of reasons, such as component failure or different component life expectancies. It would be advantageous to provide a user friendly mechanism for connecting and disconnecting components of the system (see Paragraph [0007]).
Regarding Claim 8, Modified Cowart teaches all of the limitations of claim 1 and Braga further teaches wherein the door is dimensioned and configured to permit removable engagement of the first and second pump engagement mechanisms with the corresponding first and second canister engagement mechanisms when the door is in an open position (door 657 is unfastened so that housing 120 may be placed on tip of canister 118, see Paragraph [0085]), and the door is dimensioned and configured to prevent disengagement of the first and second pump engagement mechanisms with the corresponding first and second canister connection engagement mechanisms when the door is in a closed position (once placed together door 657 is closed and locked in place, see Paragraph [0085]) and the canister is fluidly connected to the pump unit (to securely engage canister 118 with housing 120, see Paragraph [0085]).
Regarding Claim 9, Modified Cowart teaches all of the limitation as discussed above in claim 8 and Figure 17 of Braga further teaches a door operatively connected to the pump unit (door 657 connected to housing 120, see Paragraph [0085]).
However, Braga does not explicitly disclose wherein the door includes one or more windows for viewing an exudate level of the canister when the door is in the closed position and the canister is fluidly connected to the pump unit.
Paragraph [0060] of Braga teaches at least a portion of collection canister 118 may be transparent to assist in evaluating the color, quality, or quantity of wound exudates.
Cowart, Locke, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the door of Braga and further include wherein the door includes a transparent window, as taught by Paragraph [0060] of Braga. Braga teaches this transparency may assist in determining the remaining capacity of the canister or when the canister should be replaced (see Paragraph [0060]).
Regarding Claim 10, Modified Cowart teaches all of the limitations of claim 1 and Cowart further teaches a wound enclosure (16) and reduced pressure tubing (20), the reduced pressure tubing configured to be fluidly connected to the canister at a proximal end (see Figure 1) and to the wound enclosure at a distal end for fluidly connecting the wound enclosure to the canister (see Figure 1).
Regarding Claim 11, Modified Cowart teaches all of the limitations of claim 1 and Cowart further teaches a wound enclosure (16) and reduced pressure tubing (20), the reduced pressure tubing configured to be fluidly connected to the canister at a proximal end (see Figure 1) and to the wound enclosure at a distal end for fluidly connecting the wound enclosure to the canister (see Figure 1).
Regarding Claim 12, Modified Cowart teaches all of the limitations of claim 1. However, Cowart and Locke do not explicitly disclose wherein the proximal end of the reduced pressure tubing is fluidly connected to an inlet port of the canister in a permanent connection and the distal end of the reduced pressure tubing is configured to be fluidly connected to the wound enclosure with a removable connection.
Braga teaches a NPWT system (see Abstract; Figure 1-2A) wherein the proximal end of the reduced pressure tubing is fluidly connected to an inlet port of the canister in a permanent connection (fluid inlet 178 connectable to conduit 106 by fluid tight means, see Paragraph [0058]; conduit connection may be permanent, see Paragraph [0052]) and the distal end of the reduced pressure tubing is configured to be fluidly connected to the wound enclosure with a removable connection (distal end of conduit 106 is configured to be removably connected with a removable connection at connector 114, see Figure 1A; connector 114 adapted to receive conduit 106 in a releasable manner, see Paragraph [0051]).
Cowart, Locke, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the reduce pressure tubing of Modified Cowart and further include wherein the proximal end of the reduced pressure tubing is fluidly connected to an inlet port of the canister in a permanent connection and the distal end of the reduced pressure tubing is configured to be fluidly connected to the wound enclosure with a removable connection, as taught by Braga. Braga teaches it would be advantageous to provide a user friendly mechanism for connecting and disconnecting components of the system (see Paragraph [0007]).
Claims 13-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cowart (US 20210275732 A1) in view of Locke (US 20140276488 A1), and further in view of Hofstetter et al. (WO 2018036691 A1, as mapped with translated copy attached), hereinafter referred to as “Hofstetter”.
Regarding Claim 13, Cowart teaches a disposable NPWT canister connection system (NPWT system 10 with disposable canister 18 for providing reduce pressure along a fluid flow path to a wound site, see Figure 1, Paragraph [0028]), the canister connection system comprising:
a canister (18) dimensioned and configured for collecting extracted exudate from a wound site (canister 18 to collect wound exudate, see Paragraph [0028]), the canister including a front surface (exterior surface adjacent to second end 83) and a rear surface (inner surface of canister connection wall 82 at the first end 81, see Figure 6), the rear surface including a canister outlet (an aperture 88 of surface 82, Figure 6) and a canister inlet (second aperture 90); and
a canister adapter (the canister 18 includes a flange 94 extending from the cannister connection wall 82), the canister adapter including one more pump engagement mechanisms (engaging mechanism 83) dimensioned and configured to removably engage one or more canister engagement mechanisms (removably receiving clip 73 of the attachment fixture 70) disposed within a first recess of a canister connection surface of a pump unit (a first end 72 that is disposed adjacent the first side 54, see Figure 4) for fluidly connecting the canister outlet to a pump inlet (pump inlet port 58 in fluid communication with the pump inlet 13, see Paragraph [0032]; and aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58 when the canister 18 is fluidly connected to the vacuum pump unit 14, see Paragraph [0035]) disposed within the first recess of the canister connection surface such that the rear surface of the canister is positioned along the canister connection surface of the pump unit (see Figures 4, 6, and 8).
However, Cowart does not explicitly disclose a canister formed of a soft material and the canister adapter formed of a more rigid material as compared to the soft material of the canister.
Locke teaches a wound fluid collection system includes a canister (see Abstract; Figures 1-2) wherein the canister is formed of a soft material (canister 102 having a flexible container 104, see Figure 1 and 2) and a canister adapter formed of a more rigid material as compared to the soft material of the canister (carrier plate 103 of the canister 102 is a thermoplastic plate that supports the container 104, see Paragraph [0021]; Figure 2; it is understood that the carrier plate is made of a more rigid material to support container 104).
Cowart and Locke art analogous art because both disclose a NPWT system for providing reduced pressure along a fluid flow path to a wound site comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister and adaptor and Cowart and further include wherein the canister is formed of a soft material and the canister adapter formed of a more rigid material as compared to the soft material of the canister, as taught by Locke. Locke teaches its beneficial for a canister having a variable volume from a first volume to a second volume, the second volume being greater than the first volume; while affixing the canister to a carrier plate, whereby the volume of the canister is maintained substantially at the second volume (see Paragraph [0028]).
Cowart and Locke teaches all of the limitations as discussed above and Cowart further teaches the rear surface (82) of the canister is positioned along the canister connection surface of the pump unit (along pump connection wall 52, see Figures 4, 6, and 8A) and wherein the rear surface (82) of the canister is dimensioned and configured to abut the canister connection surface of the pump unit along the length of the canister when the canister is fluidly connected to the pump unit (along pump connection wall 52, see Figures 4, 6, and 8A) with the one or more canister engagement mechanisms (first engaging mechanism 83).
However, Cowart and Locke do not explicitly disclose a tubing adapter for fluidly connecting the canister inlet to a proximal end of reduced pressure tubing, the tubing adapter dimensioned and configured to be disposed within a second recess of the canister connection surface of the pump unit when the canister is fluidly connected to the pump unit and the rear surface of the canister is positioned along the canister connection surface of the pump unit, and
the one or more pump engagement mechanisms being disposed within the first recess of the canister connection surface and the tubing adapter being disposed within the second recess of the canister connection surface.
Hofstetter teaches a NPWT system for providing reduced pressure along a fluid flow path to a wound site (system 2, see Figure 1A; Paragraphs [0132]-[0134]) comprising: a detachable canister (6) wherein the canister further a tubing adapter (connection point 36) for fluidly connecting the canister inlet to a proximal end of reduced pressure tubing (to connect to proximal end of tubing 14, see Figures 2A and 3B; pg. 9 ln 25), the tubing adapter dimensioned and configured to be disposed within a second recess of the canister connection surface of the pump unit when the canister is fluidly connected to the pump unit (disposed within second rear recess in the top surface of 6, see Figure 2B),and
the one or more pump engagement mechanisms being disposed within the first recess of the canister connection surface (top surface 4 includes a first front recess; the front recess includes connection point 30a for the pump inlet and sliding guide means 24a for canister engagements 24b, see Figure 2B) and the tubing adapter being disposed within the second recess of the canister connection surface (connection point 36 disposed within second rear recess in the top surface of 6, see Figure 2B).
Cowart, Locke, and Hofstetter are all analogous art because all teach a negative pressure wound therapy system comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister connecting surface and further include wherein the canister connecting surface includes: the first recess including the pump inlet, first canister engagement mechanism, and the second canister engagement mechanism, the first recess dimensioned and configured to receive the first and second pump engagement mechanisms of the canister adapter, and a second recess dimensioned and configured to receive the tubing adapter, as taught by Hofstetter. Hofstetter teaches the first and the second housing part are, in particular for replacing a full against an unused container, which is formed by the second housing part, manually releasably fixed to each other (see pg. 3 ln 6-8).
Regarding Claim 14, Modified Cowart teaches all of the limitations of claim 13 and Cowart further teaches wherein the canister adapter is formed of a rigid plastic (a thermoplastic plate that supports the container 104, see Paragraph [0021]) and the canister is formed of a soft plastic (a pneumatic pouch 160 disposed within the chamber of the container 104 formed from a flexible thermoplastic material that is collapsible, see Paragraph [0025]).
Regarding Claim 15, Modified Cowart teaches all of the limitations of claim 14 and Cowart further teaches wherein: the one or more pump engagement mechanisms of the canister adapter includes a first pump engagement mechanism having a deflectable tab (latch 85 having a tab 92, see Figure 8B-C) configured to deflect inward as it traverses a locking surface of the one or more canister engaging mechanisms (the tab 92 is able to gradually flex inward until the tab 92 reaches the opening 76 of the latch receptacle 75, see Paragraph 0085]) and then deflect outward as the deflectable tab passes the locking surface to fluidly connect the canister to the pump unit (once the tab 92 reaches the opening 76 of the latch receptacle 75, the depressible latch 85 snaps back towards its resting position, see Paragraph [0038]).
Regarding Claim 17, Modified Cowart teaches all of the limitations of claim 13 and Cowart further teaches wherein the connection system further includes a wound enclosure (16), the reduced pressure tubing configured to be fluidly connected to the canister inlet at the proximal end (see Figure 1A) and to the wound enclosure at a distal end for fluidly connecting the wound enclosure to the canister (see Figure 1A).
Regarding Claim 18, Modified Cowart teaches all of the limitations of claim 17 and Cowart further teaches wherein the wound enclosure includes a filtered vent port (second flow path 22 via lumen 26 to the wound enclosure 16 including a filter 30, see Figure 1) for introducing filtered atmospheric air into the reduced pressure tubing for facilitating a flow of exudate from a wound site to the canister through the reduced pressure tubing (using appropriate filters 28 in combination the pump outlet 15 as the secondary pressure source 24, the NPWT system 10 may be used to create an active circulation of air flow between the canister 18 and the wound enclosure 16, see Paragraph [0030]).
Claims 16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Modified Cowart and as applied to claim 13 above, and further in view of Braga et al. (US 20090240218 A1), hereinafter referred to as “Braga”.
Regarding Claim 16, Modified Cowart teach all of the limitations of claim 15. However, Cowart and Locke do not explicitly disclose wherein one or more pump engagement mechanisms of the canister adapter further includes a second pump engagement mechanism having an alignment tab dimensioned and configured to be positioned in a tab receiver of the one or more canister engaging mechanisms to align the canister adapter with the canister connection surface when the second pump engagement mechanism engages the tab receiver of the one or more canister engagement mechanisms.
Braga teaches a NPWT system (see Abstract) comprising a pump unit (control unit 256) having a canister connecting surface (lower connecting surface of 256 for connecting to canister 258, see Figure 3A), wherein one or more pump engagement mechanisms of the canister adapter further includes a second pump engagement mechanism (262); wherein the second pump engagement mechanism includes an alignment tab (tab 260) dimensioned and configured to be positioned in a tab receiver of the one or more canister engaging mechanisms (slot 262) to align the canister adapter with the canister connection surface when the second pump engagement mechanism engages the tab receiver of the one or more canister engagement mechanisms (tab 260 is received in slot 262, see Figure 4A; Paragraph [0064]).
Cowart, Locke, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the one or more pump engagement mechanisms of the canister adapter and second canister engagement mechanism of Modified Cowart and replace it with the one or more canister engagement mechanisms including an alignment tab, and the second canister engagement mechanism including a second tab receiver configured to receive the alignment tab when the second pump engagement mechanism engages the second canister engagement mechanism, as taught by Braga. Braga teaches the various components of the wound therapy system may need to be disconnected or be replaced for a variety of reasons, such as component failure or different component life expectancies. It would be advantageous to provide a user friendly mechanism for connecting and disconnecting components of the system (see Paragraph [0007]).
Regarding Claim 19, Modified Cowart teaches all of the limitations of claim 17. However, Modified Cowart do not explicitly disclose wherein the proximal end of the reduced pressure tubing is fluidly connected to the canister inlet in a permanent connection and the distal end of the reduced pressure tubing is configured to be fluidly connected to the wound enclosure with a removable connection.
Braga teaches a disposable NPWT system (see Abstract) wherein the proximal end of the reduced pressure tubing is fluidly connected the canister inlet in a permanent connection (fluid inlet 178 connectable to conduit 106 by fluid tight means, see Paragraph [0058]; conduit connection may be permanent, see Paragraph [0052]) and the distal end of the reduced pressure tubing is configured to be fluidly connected to the wound enclosure with a removable connection (distal end of conduit 106 is configured to be removably connected with a removable connection at connector 114, see Figure 1A; connector 114 adapted to receive conduit 106 in a releasable manner, see Paragraph [0051]).
Cowart, Locke, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the reduce pressure tubing of Modified Cowart and further include wherein the proximal end of the reduced pressure tubing is fluidly connected to the canister inlet in a permanent connection and the distal end of the reduced pressure tubing is configured to be fluidly connected to the wound enclosure with a removable connection, as taught by Braga. Braga teaches it would be advantageous to provide a user friendly mechanism for connecting and disconnecting components of the system (see Paragraph [0007]).
Regarding Claim 20, Modified Cowart teach all of the limitations of claim 19 and Braga further teaches wherein the tubing adapter includes a bottom surface sealed around the canister inlet and an inlet port for providing the permanent connection to the proximal end of the reduced pressure tubing (fluid inlet 178 having a bottom surface sealed around the inlet into chamber 176 and including a port for port for providing the permanent connection to the proximal end of conduit 106, see Figure 1B; fluid inlet 178 may be connectable with conduit 106 by conventional air and fluid tight means, see Paragraph [0058]; conduit connection may be permanent, see Paragraph [0052]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Modified Cowart as applied to claim 1 above, and further in view of Barr et al. (US 20160250398 A1), hereinafter referred to as “Barr”.
Regarding Claim 5, Modified Cowart teaches all of the limitations as discussed above in claim 1. However, Modified Cowart does not explicitly disclose wherein:
the canister connecting surface includes a protrusion disposed around the pump inlet and a groove formed into the canister connecting surface around a base of the protrusion, and
one of the canister and the canister adapter includes a sealing member configured to be disposed around the canister outlet, the sealing member dimensioned and configured to fit within the groove of the canister connecting surface to form a sealed connection between the pump inlet and the canister outlet when the canister is fluidly connected to the pump unit.
Barr teaches a NPWT system (see Abstract; Figure 1-2A) comprising a canister (14) wherein:
the canister connecting surface (rear housing 16b) includes a protrusion disposed around the pump inlet and a groove formed into the canister connecting surface around a base of the protrusion (protrusion/port 34 disposed around the pump inlet and a groove 36 around the base of protrusion 34, see Figure 2A; Paragraph [0020]), and
one of the canister and the canister adapter includes a sealing member configured to be disposed around the canister outlet (sealing member 54 configured to be disposed around the canister outlet, see Figure 2A), the sealing member dimensioned and configured to fit within the groove of the canister connecting surface to form a sealed connection between the pump inlet and the canister outlet when the canister is fluidly connected to the pump unit (sealing member 54 is configured to fit within the groove 36 to from a sealed connection, see Figure 2A-D; tubular conduit 54 is able to reliably seal to conduit seat 36 and transmit suction to canister 14, see Paragraph 0029]).
Modified Cowart and Barr are analogous art because all teach a negative pressure system comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister connecting surface of Modified Cowart and further include a protrusion disposed around the pump inlet and a groove formed into the canister connecting surface around a base of the protrusion, and one of the canister and the canister adapter includes a sealing member configured to be disposed around the canister outlet, the sealing member dimensioned and configured to fit within the groove of the canister connecting surface to form a sealed connection between the pump inlet and the canister outlet when the canister is fluidly connected to the pump unit, as taught by Barr. Barr teaches as noted the shape of conduit seat 36 aids in reducing the likelihood of any fluids that come into contact with housing 16 from being deposited within the output port 34 (see Paragraph [0031]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cowart, Locke, and Braga as applied in claim 1, and further in view of Hofstetter et al. (WO 2018036691 A1, as mapped with translated copy attached), hereinafter referred to as “Hofstetter”.
Regarding Claim 6, Modified Cowart teaches all of the limitations as discussed above in claim 1. However, Modified Cowart does not explicitly disclose wherein the canister further includes a tubing adapter for fluidly connecting to a proximal end of reduced pressure tubing.
Hofstetter teaches a NPWT system for providing reduced pressure along a fluid flow path to a wound site (system 2, see Figure 1A; Paragraphs [0132]-[0134]) comprising a detachable canister (6) wherein the canister further includes a tubing adapter (connection point 36) for fluidly connecting to a proximal end of reduced pressure tubing (to connect to proximal end of tubing 14, see Figures 2A and 3B; pg. 9 ln 25).
Modified Cowart and Hofstetter are all analogous art because all teach a negative pressure wound therapy system comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister of Modified Cowart and further include wherein the canister further includes a tubing adapter for fluidly connecting to a proximal end of reduced pressure tubing, as taught by Hofstetter. Hofstetter teaches it is beneficial to have a tubing adapter when using the device for negative pressure therapy of wounds to create an occlusive pressure tight wound (see Col. 9 ln 26-27).
Regarding Claim 7, Modified Cowart teaches all of the limitations as discussed above in claim 6. However, Modified Cowart does not explicitly disclose wherein the canister connecting surface includes:
a first recess including the pump inlet, first canister engagement mechanism, and the second canister engagement mechanism, the first recess dimensioned and configured to receive the first and second pump engagement mechanisms of the canister adapter, and
a second recess dimensioned and configured to receive the tubing adapter.
Hofstetter teaches a NPWT system for providing reduced pressure along a fluid flow path to a wound site (system 2, see Figure 1A; Paragraphs [0132]-[0134]) wherein the canister connecting surface includes:
a first recess (top surface 4 includes a first front recess, see Figure 2B) including the pump inlet, first canister engagement mechanism, and the second canister engagement mechanism (front recess includes connection point 30a for the pump inlet and sliding guide means 24a for canister engagements 24b, see Figure 2B), the first recess dimensioned and configured to receive the first and second pump engagement mechanisms of the canister adapter (for engagements 24b, see Figure 2B), and
a second recess dimensioned and configured to receive the tubing adapter (second rear recess in the top surface of 6, see Figure 2B).
Cowart, Locke, and Hofstetter are all analogous art because all teach a negative pressure wound therapy system comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister connecting surface and further include wherein the canister connecting surface includes: a first recess including the pump inlet, first canister engagement mechanism, and the second canister engagement mechanism, the first recess dimensioned and configured to receive the first and second pump engagement mechanisms of the canister adapter, and a second recess dimensioned and configured to receive the tubing adapter, as taught by Hofstetter. Hofstetter teaches the first and the second housing part are, in particular for replacing a full against an unused container, which is formed by the second housing part, manually releasably fixed to each other (see pg. 3 ln 6-8).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cowart (US 20210275732 A1) in view of Locke (US 20140276488 A1), further in view of Hofstetter et al. (WO 2018036691 A1, as mapped with translated copy attached), hereinafter referred to as “Hofstetter”, and in further view of Braga (US 20090240218 A1).
Regarding Claim 21, Cowart a disposable NPWT system for providing reduced pressure along a fluid flow path to a wound site (NPWT system 10 with disposable canister 18 for providing reduce pressure along a fluid flow path to a wound site, see Figure 1, Paragraph [0028]), the disposable NPWT system comprising:
a pump unit (vacuum pump unit 14) having a canister connecting surface (52), the canister connecting surface including:
a first recess having one or more canister engagement mechanisms (a first end 72 that is disposed adjacent the first side 54 having removably receiving clip 73 of the attachment fixture 70, see Figure 4),
a pump inlet disposed within the first recess (pump inlet port 58 in fluid communication with the pump inlet 13, see Paragraph [0032],
a canister (18) dimensioned and configured for collecting extracted exudate from a wound site (canister 18 to collect wound exudate, see Paragraph [0028]), the canister having a front surface (exterior surface adjacent to second end 83) and a rear surface (inner surface of canister connection wall 82 at the first end 81, see Figure 6), the rear surface having a canister outlet (an aperture 88 of surface 82, Figure 6), a canister inlet (second aperture 90), and
a canister adapter (the canister 18 includes a flange 94 extending from the cannister connection wall 82), the canister adapter having one or more pump engagement mechanisms (engaging mechanism 83) configured to removably engage the one or more canister engagement mechanisms (removably receiving clip 73 of the attachment fixture 70) for securing the canister to the pump unit such that the canister outlet is fluidly connected to the pump inlet with the one or more canister engagement mechanisms (pump inlet port 58 in fluid communication with the pump inlet 13, see Paragraph [0032]; and aperture 88 positioned to be fluidly coupled and aligned with the pump inlet port 58 when the canister 18 is fluidly connected to the vacuum pump unit 14, see Paragraph [0035]), and the rear surface of the canister is positioned along the canister connecting surface of the pump unit (see Figures 2-6); and
However, Cowart does not explicitly disclose a canister formed of a soft material and the canister adapter formed of a more rigid material as compared to the soft material of the canister.
Locke teaches a wound fluid collection system includes a canister (see Abstract; Figures 1-2) wherein the canister is formed of a soft material (canister 102 having a flexible container 104, see Figure 1 and 2) and a canister adapter formed of a more rigid material as compared to the soft material of the canister (carrier plate 103 of the canister 102 is a thermoplastic plate that supports the container 104, see Paragraph [0021]; Figure 2; it is understood that the carrier plate is made of a more rigid material to support container 104).
Cowart and Locke art analogous art because both disclose a NPWT system for providing reduced pressure along a fluid flow path to a wound site comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister and adaptor and Cowart and further include wherein the canister is formed of a soft material and the canister adapter formed of a more rigid material as compared to the soft material of the canister, as taught by Locke. Locke teaches its beneficial for a canister having a variable volume from a first volume to a second volume, the second volume being greater than the first volume; while affixing the canister to a carrier plate, whereby the volume of the canister is maintained substantially at the second volume (see Paragraph [0028]).
Cowart and Locke teaches all of the limitations as discussed above. However, Cowart and Locke do not explicitly disclose the one or more pump engagement mechanisms disposed within the first recess; a tubing adapter for fluidly connecting the canister inlet to a proximal end of reduced pressure tubing, and the tubing adapter is disposed within a second recess.
Hofstetter teaches a NPWT system for providing reduced pressure along a fluid flow path to a wound site (system 2, see Figure 1A; Paragraphs [0132]-[0134]) comprising: a detachable canister (6) wherein the canister further a tubing adapter (connection point 36) for fluidly connecting the canister inlet to a proximal end of reduced pressure tubing (to connect to proximal end of tubing 14, see Figures 2A and 3B; pg. 9 ln 25), the tubing adapter dimensioned and configured to be disposed within a second recess of the canister connection surface of the pump unit when the canister is fluidly connected to the pump unit (disposed within second rear recess in the top surface of 6, see Figure 2B),and
the one or more pump engagement mechanisms being disposed within a first recess of the canister connection surface (top surface 4 includes a first front recess; the front recess includes connection point 30a for the pump inlet and sliding guide means 24a for canister engagements 24b, see Figure 2B) and the tubing adapter being disposed within the second recess of the canister connection surface (connection point 36 disposed within second rear recess in the top surface of 6, see Figure 2B).
Cowart, Locke, and Hofstetter are all analogous art because all teach a negative pressure wound therapy system comprising a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister connecting surface and further include wherein the first recess dimensioned and configured to receive the one or more pump engagement mechanisms of the canister adapter, and a second recess dimensioned and configured to receive the tubing adapter, as taught by Hofstetter. Hofstetter teaches the first and the second housing part are, in particular for replacing a full against an unused container, which is formed by the second housing part, manually releasably fixed to each other (see pg. 3 ln 6-8).
Modified Cowart teaches all of the limitations as discussed above. However, Modified Cowart does not explicitly disclosed a door operatively connected to the pump unit for substantially covering the front surface of the canister and maintaining the positioning of the rear surface of the canister along the connecting surface of the pump unit when the door is in a closed position such that the canister is disposed between the canister connecting surface and the door.
Braga teaches a NPWT system (see Abstract; Figure 1-2A and 17) comprising a canister (14) comprising a door operatively connected to the pump unit for substantially covering the front surface of the canister (door 657 connected to housing 120 on a front surface of the canister, see Paragraph [0085]; Figure 17) and maintaining the positioning of the rear surface of the canister along the connecting surface of the pump unit when the door is in a closed position such that the canister is disposed between the canister connecting surface and the door (once placed together door 657 is closed and locked in place to securely engage canister 118 with housing 120, see Paragraph [0085]).
Cowart, Locke, Hofstetter, and Braga are all analogous art because all teach a wound therapy system having a canister.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the canister and pump unit of Modified Cowart and further include a door operatively connected to the pump unit, as taught by Braga. Braga teaches it would be advantageous to provide a user friendly mechanism for connecting and disconnecting components of the system (see Paragraph [0007]).
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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/ERIC RASSAVONG/ (7/2/2026)
Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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