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 Objections
Claim 22 is objected to because of the following informalities:
Claim 22, line 1: “The system claim 21…” should read “The system of claim 21…”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 15-16, 18-20, and 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Locke et al. (Publication No. US 2014/0005618 A1).
Regarding claim 1, Locke discloses a system for treating a tissue site (system 100 for treating a tissue site 102; Figure 3; Paragraph 0069), the system comprising:
a dressing configured to be positioned at the tissue site (dressing 112 is positioned on tissue site 102; Figure 3; Paragraph 0069);
a therapy device configured to fluidly couple to the dressing (base unit 114 and source 116; Figure 3; Paragraph 0065), the therapy device comprising:
a pump configured to deliver negative pressure to the dressing (reduced pressure source 116; Figure 3; Paragraph 0065),
a first wireless communication device (remote base unit 114 has a RFID reader/antenna 146; Paragraph 0053-0054; Figure 3), and
a controller configured to control the pump (control 158 controls source 116; Paragraph 0053; Figure 3); and
a pressure sensing device configured to be fluidly coupled to the dressing at a sensing location external to the therapy device and to wirelessly communicate a pressure signal from the sensing location to the first wireless communication device (board 127 containing sensors 126 and 142 is fluidly coupled to dressing 112 at a sensing location external to base unit 114 and source 116 and to wirelessly communicate a pressure signal from the sensing location to the RFID reader/antenna 146; Figure 3; Paragraph 0030, 0040-0042, and 0050-0051).
Regarding claim 15, Locke discloses the system of claim 1. Locke further discloses further comprising a conduit configured to fluidly couple the pump of the therapy device to the dressing (conduit 134 is fluidly coupled between the pump 116 of the therapy device to the dressing 112; Figure 3; Paragraph 0063 and 0080).
Regarding claim 16, Locke discloses the system of claim 15. Locke further discloses wherein the conduit is a single lumen conduit extending from the pump to the dressing (conduit 134 is a single lumen between the pump 116 of the therapy device to the dressing 112; Figure 3; Paragraph 0063 and 0080).
Regarding claim 18, Locke discloses the system of claim 1. Locke further discloses wherein the pressure sensing device is carried by a conduit connection assembly configured to be coupled between the therapy device and the dressing (reduced pressure interface 132b holds pressure sensing device 127 with sensors and is coupled between the therapy device 114/116 and the dressing 112; Paragraph 0049; Figure 2A and 3), the conduit connection assembly including a single lumen conduit connection at a first end and a multi-lumen conduit connection at a second end (interface 132b has a single lumen conduit connection at first end and a multi-lumen conduit connection at a second end; see annotated Figure 2a below), the single lumen conduit connection configured to fluidly couple to a single lumen conduit between the pump and the first end (single lumen conduit connection coupled to a single lumen conduit 134 between pump 116 and the first end; annotated Figure 2A below and Figure 3), the multi-lumen conduit connection configured to fluidly couple to a multi-lumen conduit between the second end and the dressing (multi-lumen conduit connection coupled to a multi-lumen conduit, rectangular box in annotated Figure 2A below, between second end and the dressing 112; annotated Figure 2A below).
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Annotated Figure 2A
Regarding claim 19, Locke discloses the system of claim 18. Locke further discloses wherein the multi-lumen conduit includes a reduced-pressure pathway fluidly isolated from a sensing pathway (multi-lumen conduit includes a reduced-pressure pathway isolated from sensing pathway 144; annotated Figure 2A above; Paragraph 0049), wherein the sensing pathway is configured to be in fluid communication between the pressure sensing device and the dressing (sensing pathway 144 is in fluid communication between pressure sensing device and dressing 112; annotated Figure 2A above; Paragraph 0049), and wherein the reduced-pressure pathway is configured to be in fluid communication between the dressing and the single lumen conduit fluidly coupled to the pump (reduced-pressure pathway in fluid communication with dressing 112 and conduit 134 that is coupled to pump 116; annotated Figure 2A above).
Regarding claim 20, Locke discloses the system of claim 15. Locke further discloses further comprising a fluid storage container configured to be coupled to an exterior of the therapy device and fluidly coupled between the pump and the dressing (canister 138 is coupled to exterior of the therapy device and fluidly coupled between pump 116 and dressing 112; Figure 3; Paragraph 0039).
Regarding claim 25, Locke discloses the system of claim 1. Locke further discloses wherein the pressure sensing device includes an RFID tag configured to communicatively couple the pressure sensing device to the therapy device when the RFID tag is within a sensing range of the therapy device (RFID tag on RFID antenna 122 of pressure sensing device to couple the pressure sensing device to the therapy device when the tag is within a sensing range; Figure 3; Paragraph 0026-0027).
Regarding claim 26, Locke discloses a system for treating a tissue site (system 100 for treating a tissue site 102; Figure 3; Paragraph 0069), the system comprising:
a dressing configured to be positioned at the tissue site (dressing 112 is positioned on tissue site 102; Figure 3; Paragraph 0069);
a therapy device comprising a pump and a wireless communication device (therapy device is unit 114 and source 116 comprising a reduced pressure source 116 and a RFID reader/antenna 146; Figure 3; Paragraph 0053-0056), the pump configured to generate a negative pressure and to provide the negative pressure to the dressing through a negative pressure pathway (source 116 generates reduced pressure to deliver reduced pressure to the dressing 112 through conduit 134; Paragraph 0038-0039; Figure 3); and
a pressure sensing device configured to be fluidly coupled to the dressing through a sensing pathway and at a sensing location external to the therapy device (housing 127 containing sensors 126 and 142 is fluidly coupled to dressing 112 at a sensing location external to base unit 114 and source 116 and senses pressure through channel 144; Figure 2A and 3; Paragraph 0030, 0040-0042, and 0049-0051), the sensing pathway fluidly isolated from the negative pressure pathway and the therapy device (channel 144 is fluidly isolated from conduit 134 and therapy device; Figures 2A and 3), the pressure sensing device further configured to wirelessly communicate a pressure signal from the sensing location to the wireless communication device (housing 127 containing sensors 126 and 142 is fluidly coupled to dressing 112 at a sensing location external to base unit 114 and source 116 and to wirelessly communicate a pressure signal from the sensing location to the RFID reader/antenna 146; Figure 3; Paragraph 0030, 0040-0042, and 0050-0051).
Claim Rejections - 35 USC § 103
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) 2, 6, 8-11, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2014/0005618 A1) in view of Askem et al. (Publication No. US 2019/0142644 A1).
Regarding claim 2, Locke discloses the system of claim 1. Locke does not teach wherein the therapy device further comprises:
a pump pressure sensor configured to sense a pressure output of the pump; and
a power source configured to provide power to the therapy device.
However, Askem teaches wherein the therapy device further comprises:
a pump pressure sensor configured to sense a pressure output of the pump (pressure sensor 12F measures pressure of negative pressure source 12C output; Figure 1; Paragraph 0024-0025); and
a power source configured to provide power to the therapy device (power source 12E; Figure 1; Paragraph 0020).
Locke and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke with the teachings of Askem and have the therapy device of Locke to have a pump pressure sensor and a power source, as taught by Askem. This would allow for the device to monitor the pressure being produced at the pump and for the power source to power the device for therapy treatment (Askem; Paragraph 0024-0025).
Regarding claim 6, Locke discloses the system of claim 1. Locke further teaches wherein the pressure sensing device comprises:
a printed circuit board comprising a first side and a second side (board 127 has a first and second side; Paragraph 0030; Figure 1D and 3);
a therapy pressure sensor configured to sense a pressure at the tissue site (sensor 126; Figure 3; Paragraph 0030 and 0040-0042);
a second wireless communication device configured to wirelessly communicate a pressure signal to the first wireless communication device (RFID antenna 122 sends pressure signal to RFID reader/antenna 146; Figure 3; Paragraph 0030 and 0050), wherein the pressure signal includes a therapy pressure value corresponding to the pressure at the tissue site (pressure signal includes a therapy pressure value; Paragraph 0041 and 0052). Locke does not teach an ambient pressure sensor configured to sense an ambient environment pressure external to the therapy device and the dressing; and an ambient pressure value corresponding to the ambient environment pressure.
However, Askem teaches an ambient pressure sensor configured to sense an ambient environment pressure external to the therapy device and the dressing (pressure sensor 12G measures pressure external to the wound, such as the ambient environment; Paragraph 0024-0025; Figure 1); and wherein the pressure signal includes an ambient pressure value corresponding to the ambient environment pressure (pressure sensor 12G produces a ambient pressure value that is sent to control circuitry 12A; Paragraph 0019-0020 and 0024-0025; Figure 1).
Locke and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke with the teachings of Askem and have the ambient pressure sensor of Askem to be on the second side of the printed board of Locke, opposing to the first side of the printed board where the therapy pressure sensor of Locke is located. This would allow for the device to monitor the pressure being produced at the pump and the pressure being delivered to the dressing (Askem; Paragraph 0024-0025).
Regarding claim 8, Locke in view of Askem teaches the system of claim 6. The combination of Locke in view of Askem further teaches wherein the therapy pressure sensor is coupled to the first side of the printed circuit board (Locke; pressure sensor 126 is on the first side of the board 127; Figure 3; Paragraph 0040-0042 and 0050-0051), and wherein the ambient pressure sensor is coupled to the second side of the printed circuit board opposite the first side and isolated from the therapy pressure sensor (pressure sensor 12G of Askem is on the second side opposing the first side of board 127 and at a distance from the therapy pressure sensor of Locke; see combination above).
Regarding claim 9, Locke in view of Askem teaches the system of claim 8. The combination of Locke in view of Askem further teaches wherein the pressure sensing device is coupled to a surface of the dressing opposite the tissue site (Locke; pressure sensing device with board 127 and sensor 126 is on the surface of the dressing 112 opposite the tissue site; Figure 2A and 3; Paragraph 0050-0051), and wherein the therapy pressure sensor on the first side of the printed circuit board is configured to face the dressing and to be exposed to the pressure at the tissue site (Locke; pressure sensor 126 is on the first side of the board 127 faces the dressing to measure pressure at tissue site 102; Figure 3; Paragraph 0040-0042 and 0050-0051).
Regarding claim 10, Locke in view of Askem teaches the system of claim 6. The combination of Locke in view of Askem further teaches wherein the pressure sensing device is coupled to a surface of the dressing opposite the tissue site (Locke; pressure sensing device with board 127 and sensor 126 is on the surface of the dressing 112 opposite the tissue site; Figure 2A and 3; Paragraph 0050-0051) and configured to be exposed to the pressure at the tissue site (Locke; pressure sensor 126 is on the first side of the board 127 faces the dressing to measure pressure at tissue site 102; Figure 3; Paragraph 0040-0042 and 0050-0051).
Regarding claim 11, Locke in view of Askem teaches the system of claim 10. The combination of Locke in view of Askem further teaches wherein the therapy pressure sensor is fluidly coupled to the tissue site through the dressing (Locke; pressure sensor 126 on board 127 is fluidly coupled to the tissue site 102 through pathway 144; Figure 2A; Paragraph 0049).
Regarding claim 27, Locke teaches a method of treating a tissue site with negative pressure (method of system 100 for treating a tissue site 102; Figure 3; Paragraph 0069; Abstract), the method comprising:
obtaining a therapy device (base unit 114 and source 116; Figure 3; Paragraph 0065) comprising:
a pump configured to deliver negative pressure (reduced pressure source 116; Figure 3; Paragraph 0065),
a first wireless communication device (remote base unit 114 has a RFID reader/antenna 146; Paragraph 0053-0054; Figure 3), and a controller configured to control the pump (control 158 controls source 116; Paragraph 0053; Figure 3);
obtaining a pressure sensing device (board 127 containing sensors 126 and 142; Figure 3; Paragraph 0030) comprising:
a printed circuit board (board 127; Figure 3; Paragraph 0030),
a therapy pressure sensor configured to sense a pressure at the tissue site (pressure sensor 126 senses a pressure at the tissue site 102; Figure 3; Paragraph 0040-0041 and 0050-0051),
and a second wireless communication device configured to wirelessly communicate a pressure signal to the first wireless communication device (RFID antenna 122 sends pressure signal to RFID reader/antenna 146; Figure 3; Paragraph 0030 and 0050), wherein the pressure signal includes a therapy pressure value corresponding to the pressure at the tissue site (pressure signal includes a therapy pressure value; Paragraph 0041 and 0052);
fluidly coupling the pump to a dressing disposed at the tissue site (pump 116 is coupled to a dressing 112 through conduit 134; Figure 3; Paragraph 0038);
fluidly coupling the pressure sensing device to the dressing disposed at the tissue site (pressure sensing device with board 127 and sensor 126 is coupled to dressing 112 at tissue site 102; Figure 2A and 3; Paragraph 0030 and 0040-0042);
actuating the pump to deliver negative pressure to the dressing (pump 116 delivers negative pressure to dressing 112; Figure 3; Paragraph 0039); and
monitoring, with the pressure sensing device, the dressing while the pump is delivering negative pressure to the dressing (sensor 126 with controller 158 is used to monitor the dressing 112 while pump 116 delivers negative pressure to dressing 112; Paragraph 0053). Locke does not teach a pump pressure sensor configured to sense a pressure at the pump, an ambient pressure sensor configured to sense an ambient environment pressure, wherein the pressure signal includes an ambient pressure value corresponding to the ambient environment pressure.
However, Askem teaches a pump pressure sensor configured to sense a pressure at the pump (pressure sensor 12F measures pressure of negative pressure source 12C output; Figure 1; Paragraph 0024-0025), an ambient pressure sensor configured to sense an ambient environment pressure (pressure sensor 12G measures pressure external to the wound, such as the ambient environment; Paragraph 0024-0025; Figure 1), wherein the pressure signal includes an ambient pressure value corresponding to the ambient environment pressure (pressure sensor 12G produces a ambient pressure value that is sent to control circuitry 12A; Paragraph 0019-0020 and 0024-0025; Figure 1).
Locke and Askem are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke with the teachings of Askem and have the ambient pressure sensor of Askem to be on the second side of the printed board of Locke, opposing to the first side of the printed board where the therapy pressure sensor of Locke is located. This would allow for the device to monitor the pressure being produced at the pump and the pressure being delivered to the dressing (Askem; Paragraph 0024-0025).
Claim(s) 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2014/0005618 A1) in view of Coulthard et al. (Publication No. US 2012/0109083 A1).
Regarding claim 21, Locke discloses the system of claim 20. Locke does not teach wherein the pressure sensing device is disposed within the fluid storage container.
However, Coulthard teaches wherein the pressure sensing device is disposed within the fluid storage container (pressure sensing device 138 is disposed within pump 108 having a reservoir 126; Paragraph 0029 and 0031; Figure 3).
Locke and Coulthard are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke with the teachings of Coulthard and have the pressure sensing device of Locke in the housing of the fluid storage container, as taught by Coulthard. This would allow for the removable connection of the pressure sensing device with the electronics from the dressing, when desired (Coulthard; Paragraph 0029 and 0031).
Regarding claim 22, Locke in view of Coulthard teaches the system of claim 21. The combination of Locke in view of Coulthard further teaches further comprising a negative pressure pathway configured to fluidly couple the pump to the dressing (Locke; conduit 134 fluidly couples pump 116 to dressing 112; Figure 3) and a sensing pathway configured to fluidly couple the pressure sensing device to the dressing (Locke; sensing pathway 144 is in fluid communication between pressure sensing device and dressing 112; annotated Figure 2A above; Paragraph 0049), wherein the pressure sensing device is not fluidly coupled to the therapy device (Locke; pressure sensing device 127/126 is not fluidly coupled to the therapy device 114/116; Figure 3).
Regarding claim 23, Locke in view of Coulthard teaches the system of claim 22. The combination of Locke in view of Coulthard further teaches wherein at least a portion of the negative pressure pathway and the sensing pathway are carried by a multi-lumen conduit configured to be fluidly coupled between the fluid storage container and the dressing (Locke; negative pressure pathway with conduit 134 and interface 132b and sensing pathway 144 is carried by a multi-lumen conduit that is fluidly coupled between fluid storage container of Coulthard and the dressing 112; Locke; annotated Figure 2A above; Paragraph 0049; Coulthard; pressure sensing device 138 is within pump 108 having a reservoir 126; Figure 3; Paragraph 0029 and 0031).
Regarding claim 24, Locke in view of Coulthard teaches the system of claim 22. The combination of Locke in view of Coulthard further teaches wherein the sensing pathway is fluidly isolated from the negative pressure pathway (Locke; sensing pathway 144 is fluidly isolated from conduit 134; annotated Figure 2A above; Paragraph 0049).
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2014/0005618 A1) in view of Askem et al. (Publication No. US 2019/0142644 A1), as applied to claim 27 above, and further in view of Long et al. (Publication No. US 2020/0353137 A1).
Regarding claim 29, Locke in view of Askem teaches the method of claim 27. The combination of Locke in view of Askem does not teach wherein monitoring, with the pressure sensing device, the dressing while the pump is delivering negative pressure to the dressing comprises comparing the pressure signal and a pump pressure measured by the pump pressure sensor to detect blockages within the dressing or between the therapy device and the dressing.
However, Long teaches wherein monitoring, with the pressure sensing device, the dressing while the pump is delivering negative pressure to the dressing comprises comparing the pressure signal and a pump pressure measured by the pump pressure sensor to detect blockages within the dressing or between the therapy device and the dressing (pump pressure and wound pressure are compared to detect blockage within tube between the therapy device and the dressing; Paragraph 0107).
Locke in view of Askem and Long are considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke in view of Askem with the teachings of Long and have the device of Locke in view of Askem detect blockages, as taught by Long. This would allow for the device to determine if the device is in a blockage state to resolve issues of the lack of negative pressure delivery to the tissue site from the pump (Long; Paragraph 0107).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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