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 .
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, 6-8, and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Selby et al. (Publication No. US 2019/0159940 A1) in view of Askem et al. (Publication No. US 2019/0142644 A1).
Regarding claim 1, Selby teaches a therapy device (device 100; Paragraph 0039; Figure 1) comprising:
a pump housing (housing of control unit 8; Paragraph 0039; Figure 1) comprising:
a pump configured to deliver negative pressure to a dressing (pump 7 is within control unit 8 and delivers vacuum to dressing 9; Paragraph 0039; Figure 1),
a controller operably coupled to the pump within an interior of the pump housing (control unit 8 and pump 7 are operably coupled in housing of control unit 8; Paragraph 0039; Figure 1), and
a first communications connector configured to provide communication with the controller from an exterior of the pump housing (connector on housing of control unit 8 at attachment region 52 allows for communication between control unit 8 at the exterior of the control unit 8 housing; Figure 1; Paragraph 0043); and
a power module configured to couple to the pump housing (connecting device 4 coupled to control unit 8 housing; Paragraph 0041-0042; Figure 1), the power module comprising:
a battery configured to provide power (power source in connecting device 4; Figure 1; Paragraph 0050),
and
a second communications connector configured to be coupled to the first communications connector to operably connect the battery to the controller (connector on connecting device 4 at attachment region 52 is to connect to control unit 8 housing; Paragraph 0042-0043; Figure 1). Selby does not teach a first pressure sensor configured to sense a pressure at the pump, and a second pressure sensor configured to sense an ambient pressure.
However, Askem teaches a first pressure sensor configured to sense a pressure at the pump (pressure sensor 12F monitors pressure in negative pressure source 12C; Figure 1; Paragraph 0024), and a second pressure sensor configured to sense an ambient pressure (pressure sensor 12G measures atmospheric pressure; Paragraph 0024; Figure 1).
Selby and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Selby to incorporate the teachings of Askem to have the first pressure sensor of Askem be connected with the pump within the pump housing of Selby and the second pressure sensor of Askem be connected to the power module of Selby, and have the controller of Selby monitor the pressure difference, as taught by Askem. This allows for the system to turn on/off the negative pressure source by calculating the pressure differences using the pressure sensors and determining if it surpasses a threshold (Askem; Paragraph 0039). The combination of Selby in view of Askem further teaches the controller operably coupled to the pump and the first pressure sensor within an interior of the pump housing (control unit 8 of Selby is operably coupled to pump 7 of Selby and first pressure sensor 12F of Askem within the housing of control unit 8; see combination above; Selby; Paragraph 0039; Figure 1; Askem; Figure 1; Paragraph 0024), the second communications connector configured to be coupled to the first communications connector to operably connect the battery and the second pressure sensor to the controller (connector on connecting device 4 at attachment region 52 is to connect the connector on housing of control unit 8 at attachment region 52 of Selby to connect battery within device 4 of Selby and second pressure sensor 12G of Askem to control unit 8; see combination above; Askem; Paragraph 0024; Figure 1; Selby; Paragraph 0039, 0042-0043, and 0050; Figure 1).
Regarding claim 6, Selby in view of Askem teaches the device of claim 1. The combination of Selby in view of Askem further teaches wherein the pump housing further comprises a dressing connection configured to fluidly couple the pump to the dressing (Selby; pathways 55/56/54 that is connected to tube 2 is the dressing connection that fluidly couples the pump 7 to the dressing 9; Figure 1; Paragraph 0041).
Regarding claim 7, Selby in view of Askem teaches the device of claim 1. The combination of Selby in view of Askem further teaches further comprising a pressure sensing module (Selby; sensor 5 with the sensor pathway of connecting device 10; Paragraph 0049; Figure 1).
The combination of Selby in view of Askem does not teach the pressure sensing module configured to be coupled between the pump housing and the power module.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensing module of Selby in view of Askem separable from the pump housing, since that it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961)(MPEP 2144.04 V.C.). The combination of Selby in view of Askem further teaches the pressure sensing module configured to be coupled between the pump housing and the power module (see combination above; Selby; Figure 1; Paragraph 0049).
Regarding claim 8, Selby in view of Askem teaches the device of claim 7. The combination of Selby in view of Askem further teaches further comprising a fluid storage container configured to be fluidly coupled between the pump and the dressing (Selby; canister 6 fluidly coupled between pump 7 and dressing 9 through pathway 56; Paragraph 0041; Figure 1).
Regarding claim 16, Selby in view of Askem teaches the device of claim 1. The combination of Selby in view of Askem further teaches wherein the pump housing has an interior chamber that is hermetically sealed from ambient environment (Selby; obvious that the control unit 8 housing would have an interior chamber of the pump 7 that is hermetically sealed from the ambient environment to maintain negative pressure for the delivery of vacuum to the wound through the dressing 9; Paragraph 0044; Figure 1).
Regarding claim 17, Selby teaches a system for treating a tissue site with negative pressure (system 100; Paragraph 0039; Figure 1; Abstract), the system comprising:
a dressing configured to couple to the tissue site (wound dressing 9 to adhere to tissue site; Paragraph 0039; Figure 1);
a pump housing (housing of control unit 8; Paragraph 0039; Figure 1) comprising:
a pump configured to deliver negative pressure to the dressing (pump 7 is within housing of control unit 8 to deliver vacuum to dressing 9; Paragraph 0039; Figure 1), and
a first communications connector configured to provide communication with the pump from an exterior of the pump housing (connector on housing of control unit 8 at attachment region 52 allows for communication between control unit 8 at the exterior of the control unit 8 housing; Figure 1; Paragraph 0043); and a power module configured to couple to the pump housing (connecting device 4 coupled to control unit 8 housing; Paragraph 0041-0042; Figure 1), the power module comprising:
a battery configured to provide power (power source in connecting device 4; Figure 1; Paragraph 0050),
a controller operably coupled to the battery (control unit 8 coupled to battery within device 4; Paragraph 0039 and 0050; Figure 1), and a second communications connector configured to be coupled to the first communications connection to operably connect the controller (connector on connecting device 4 at attachment region 52 is to connect to control unit 8 housing; Paragraph 0042-0043; Figure 1). Selby does not teach a first pressure sensor configured to sense a pressure at the pump, a second pressure sensor configured to sense an ambient pressure.
However, Askem teaches a first pressure sensor configured to sense a pressure at the pump (pressure sensor 12F monitors pressure in negative pressure source 12C; Figure 1; Paragraph 0024), and a second pressure sensor configured to sense an ambient pressure (pressure sensor 12G measures atmospheric pressure; Paragraph 0024; Figure 1).
Selby and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Selby to incorporate the teachings of Askem to have the first pressure sensor of Askem be connected with the pump within the pump housing of Selby and the second pressure sensor of Askem be connected to the power module of Selby, and have the controller of Selby monitor the pressure difference, as taught by Askem. This allows for the system to turn on/off the negative pressure source by calculating the pressure differences using the pressure sensors and determining if it surpasses a threshold (Askem; Paragraph 0039).
The combination of Selby in view of Askem further teaches the controller operably coupled to the first pressure sensor, and the second pressure sensor within an interior of the power module (control unit 8 of Selby is operably coupled to first pressure sensor 12F of Askem and second pressure sensor 12G of Askem that is located within inside device 4 of Selby; see combination above; see combination above; Selby; Paragraph 0039; Figure 1; Askem; Figure 1; Paragraph 0024), the second communications connector configured to be coupled to the first communications connection to operably connect the controller and the first pressure sensor to the pump (connector on connecting device 4 at attachment region 52 is to connect the connector on housing of control unit 8 at attachment region 52 of Selby to connect control unit 8 of Selby and first pressure sensor 12F of Askem to pump 7 of Selby; see combination above; Askem; Paragraph 0024; Figure 1; Selby; Paragraph 0039, 0042-0043, and 0050; Figure 1).
Regarding claim 18, Selby teaches a method of treating a tissue site with negative pressure (method of using system 100 to treat tissue sight using vacuum; Paragraph 0039; Figure 1; Abstract), the method comprising:
obtaining a pump housing (housing of control unit 8; Paragraph 0039; Figure 1), comprising:
a pump configured to generate negative pressure (pump 7 is within control unit 8 housing to deliver vacuum to dressing 9; Paragraph 0039; Figure 1),
a controller operably coupled to the pump (control unit 8 and pump 7 are operably coupled in housing of control unit 8; Paragraph 0039; Figure 1);
obtaining a power module (connecting device 4; Paragraph 0041-0042; Figure 1), comprising:
a battery configured to provide power (power source in connecting device 4; Figure 1; Paragraph 0050), and
coupling the pump housing to the power module to form a therapy device (connecting device 4 coupled to control unit 8 housing at attachment region 52 to form therapy device; Paragraph 0041-0043; Figure 1), wherein the battery is operably connected to the controller (power source in connecting device 4 and operably connected to control unit 8; Figure 1; Paragraph 0050);
fluidly coupling the pump to a dressing disposed at the tissue site dressing (Selby; pathways 55/56/54 that is connected to tube 2 fluidly couples the pump 7 to the dressing 9; Figure 1; Paragraph 0041);
actuating the pump to deliver negative pressure to the dressing (pump 7 is within control unit 8 and delivers vacuum to dressing 9; Paragraph 0039; Figure 1); and
monitoring, with the therapy device, the dressing while the pump is delivering negative pressure to the dressing (sensor 5 of therapy device monitors the pressure at the dressing 9 when pump 7 delivers vacuum to dressing 9; Figure 1; Paragraph 0039-0042). Selby does not teach a first pressure sensor configured to sense a pressure at the pump, and a second pressure sensor configured to sense an ambient pressure.
However, Askem teaches a first pressure sensor configured to sense a pressure at the pump (pressure sensor 12F monitors pressure in negative pressure source 12C; Figure 1; Paragraph 0024), and a second pressure sensor configured to sense an ambient pressure (pressure sensor 12G measures atmospheric pressure; Paragraph 0024; Figure 1).
Selby and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Selby to incorporate the teachings of Askem to have the first pressure sensor of Askem be connected with the pump within the pump housing of Selby and the second pressure sensor of Askem be connected to the power module of Selby, and have the controller of Selby monitor the pressure difference, as taught by Askem. This allows for the system to turn on/off the negative pressure source by calculating the pressure differences using the pressure sensors and determining if it surpasses a threshold (Askem; Paragraph 0039). The combination of Selby in view of Askem further teaches the controller operably coupled to the pump and the first pressure sensor within an interior of the pump housing (control unit 8 of Selby is operably coupled to pump 7 of Selby and first pressure sensor 12F of Askem within the housing of control unit 8; see combination above; Selby; Paragraph 0039; Figure 1; Askem; Figure 1; Paragraph 0024); and wherein the second pressure sensor is operably connected to the controller (second pressure sensor 12G of Askem is connected to control unit 8 of Selby; see combination above; Askem; Paragraph 0024; Figure 1; Selby; Paragraph 0039; Figure 1).
Regarding claim 19, Selby in view of Askem teaches the method of claim 18. The combination of Selby in view of Askem further teaches further comprising a pressure sensing module (Selby; sensor 5 with the sensor pathway of connecting device 10; Paragraph 0049; Figure 1), the pressure sensing module comprising a third pressure sensor (Selby; sensor 5; Paragraph 0049; Figure 1). The combination of Selby in view of Askem does not teach coupling the pressure sensing module between the pump housing and the power module of the therapy device.
However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensing module of Selby in view of Askem separable from the pump housing, since that it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961)(MPEP 2144.04 V.C.). The combination of Selby in view of Askem further teaches coupling the pressure sensing module between the pump housing and the power module of the therapy device (see combination above; Selby; Figure 1; Paragraph 0049).
Regarding claim 20, Selby in view of Askem teaches the method of claim 19. Selby further teaches wherein coupling the therapy device to the dressing disposed at the tissue site comprises coupling the therapy device to a dressing connector (therapy device is connected to dressing 9 at connector 41 with tube 2/pathways 55/56/54 and line 1; Paragraph 0040; Figure 1), the dressing connector comprising:
a first connector configured to couple to the pump housing in fluid communication with the pump (line 2 with pathways 55/56/54 is coupled to housing of unit 8 and in fluid communication with pump 7; Figure 1; Paragraph 0041);
a second connector configured to couple to the pressure sensing module in fluid communication with the third pressure sensor (line 1 coupled to sensor 5 and pathway/pressure sensing module in fluid communication with sensor 5; Figure 1; Paragraph 0041);
a negative pressure pathway configured to fluidly couple the first connector and the pump to the dressing (pathways 55/56/54 is negative pressure pathway that fluidly couples line 2 with pump 7 to dressing 9; Paragraph 0041; Figure 1); and
a sensing pathway configured to fluidly couple the second connector and the third pressure sensor to the dressing (pathway 51 fluidly couples line 1 and sensor 5; Figure 1; Paragraph 0042).
Regarding claim 21, Selby in view of Askem teaches the method of claim 20. Selby further teaches further comprising collecting fluid from the tissue site in a canister of the therapy device (collect fluid into canister 6 of therapy device; Figure 1; Paragraph 0039 and 0041), the canister configured to be coupled in fluid communication with the negative pressure pathway between the pump and the dressing (canister 6 is fluidly coupled to pathways 55/56/54 between pump 7 and dressing 9; Figure 1; Paragraph 0041).
Regarding claim 22, Selby in view of Askem teaches the method of claim 19. Selby further teaches wherein monitoring, with the therapy device, the dressing while the pump is delivering negative pressure to the dressing comprises monitoring the pressure at the tissue site with the pressure sensing module (sensor 5 of pressure sensing module monitors the pressure at the tissue site when the pump 7 delivers vacuum; Figure 1; Paragraph 0042 and 0049).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Selby et al. (Publication No. US 2019/0159940 A1) in view of Askem et al. (Publication No. US 2019/0142644 A1), as applied to claim 1 above, and further in view of Locke et al. (Publication No. US 2014/0005618 A1).
Regarding claim 4, Selby in view of Askem teaches the device of claim 1. The combination of Selby in view of Askem does not teach wherein the pump housing further comprises a wireless communication device operably coupled to the controller.
However, Locke teaches wherein the pump housing further comprises a wireless communication device operably coupled to the controller (negative pressure source 112 and remote base unit 14 is an integrated unit and comprises a RFID reader/antenna 146; Figure 3; Paragraph 0039 and 0053-0054).
Selby in view of Askem and Locke are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Selby in view of Askem to incorporate the teachings of Locke to have the wireless communication device of Locke coupled to the controller within the pump housing of Selby in view of Askem. This allows for the controller of the device to receive data from the dressing and identify the dressing that is compatible with the device (Locke; Paragraph 0054-0056).
Claim(s) 15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Selby et al. (Publication No. US 2019/0159940 A1) in view of Askem et al. (Publication No. US 2019/0142644 A1), as applied to claims 1 and 18 above, and further in view of Hall et al. (Publication No. US 2012/0123358 A1).
Regarding claim 15, Selby in view of Askem teaches the device of claim 1. The combination of Selby in view of Askem does not teach further comprising a blockage detection module configured to detect blockages within the dressing or between the therapy device and the dressing.
However, Hall teaches further comprising a blockage detection module configured to detect blockages within the dressing or between the therapy device and the dressing (controller 156 with sensing conduit 126 activates an indicator 160/162 when a blockage is detected in the dressing; Paragraph 0030).
Selby in view of Askem and Hall are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Selby in view of Askem to incorporate the teachings of Hall to have the blockage detection module of Hall be connected to the controller of Selby in view of Askem with the controller detecting blockages, as taught by Hall. This allows for the user to be informed about the blockage to resolve the issue (Hall; Paragraph 0030).
Regarding claim 23, Selby in view of Askem teaches the method of claim 18. The combination of Selby in view of Askem does not teach wherein monitoring, with the therapy device, the dressing while the pump is delivering negative pressure to the dressing comprises using a blockage detection module of the therapy device to detect blockages within the dressing or between the therapy device and the dressing.
However, Hall teaches wherein monitoring, with the therapy device, the dressing while the pump is delivering negative pressure to the dressing comprises using a blockage detection module of the therapy device to detect blockages within the dressing or between the therapy device and the dressing (method of using the controller 156 with sensing conduit 126 activates an indicator 160/162 when a blockage is detected in the dressing; Paragraph 0030).
Selby in view of Askem and Hall are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Selby in view of Askem to incorporate the teachings of Hall to have the blockage detection module of Hall be connected to the controller of Selby in view of Askem with the controller detecting blockages, as taught by Hall. This allows for the user to be informed about the blockage to resolve the issue (Hall; Paragraph 0030).
Allowable Subject Matter
Claims 9-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
REASONS FOR INDICATING ALLOWABLE SUBJECT MATTER
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, alone or in combination, fails to discloses all of the structural and functional limitations as described in the claims.
The invention is drawn to a negative pressure wound therapy device having a pump housing and a power module that are connected to each other between a first communications connector and a second communications connector. The pump housing comprises a pump, a controller, and a first pressure sensor to measure the pressure in the pump. The power module comprises a battery and a second pressure sensor to measure ambient pressure. The pressure module with a third sensor has a third communications connector that is connected to the first communications connector and the second communications connector. The closest prior art are Selby et al. (Publication No. US 2019/0159940 A1) and Askem et al. (Publication No. US 2019/0142644 A1), with none of the references disclosing the required claim limitations of “…wherein the pressure sensing module comprises a third pressure sensor and a third communications connector, and wherein the third communications connector is configured to be coupled between the first communications connector and the second communications connector to operably connect the third pressure sensor to the controller…”, as required by dependent claim 9.
Instead, Selby discusses a negative pressure wound therapy device (device 100; Paragraph 0039; Figure 1) having a pump housing (housing of control unit 8; Paragraph 0039; Figure 1) and a power module (connecting device 4; Paragraph 0041-0042; Figure 1) that are connected to each other between a first communications connector and a second communications connector (connector on connecting device 4 at attachment region 52 is to connect to control unit 8 housing; Paragraph 0042-0043; Figure 1). The pump housing (housing of control unit 8; Paragraph 0039; Figure 1) comprises a pump (pump 7; Paragraph 0039; Figure 1) and a controller (control unit 8; Paragraph 0039; Figure 1). The power module (connecting device 4; Paragraph 0041-0042; Figure 1) comprises a battery (power source in connecting device 4; Figure 1; Paragraph 0050). Selby does not teach a first pressure sensor, a second pressure sensor, or the pressure module with a third communications connector that is connected to the first communications connector and the second communications connector.
Askem instead discusses a negative pressure wound therapy device (Figure 1; Abstract) with a first pressure sensor configured to sense a pressure at the pump (pressure sensor 12F monitors pressure in negative pressure source 12C; Figure 1; Paragraph 0024), and a second pressure sensor configured to sense an ambient pressure (pressure sensor 12G measures atmospheric pressure; Paragraph 0024; Figure 1). Askem does not teach a pump housing, a power module, or a pressure module a third communications connector that is connected to a first communications connector and a second communications connector.
The closest is the disclosure of Selby, however, the prior art, alone or in combination does not teach the pressure module with a third communications connector that is connected to the first communications connector and the second communications connector, since it would require the additional modification of structure which would disrupt the performance of the device of the prior art combination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Locke et al. (Publication No. US 2020/0030500 A1): discusses a NPWT device with a pump housing and a power module;
Mou et al. (Publication No. US 2021/0369503 A1): discusses a NPWT device with a power module and a pump housing.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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