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 .
Election/Restrictions
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/27/2026.
Applicant’s election without traverse of claims 1-20, group I in the reply filed on 02/27/2026 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-8, 14-15, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (Publication No. US 2020/0171217 A9) in view of Tang et al. (Publication No. US 2009/0229606 A1).
Regarding claim 1, Braga teaches a negative pressure wound therapy system (apparatus 200; Abstract; Figure 2; Paragraph 0075) comprising:
a negative pressure source configured to provide negative pressure to a wound covered by a wound dressing and to aspirate fluid from the wound (suction pump 1360 in canister assembly to provide suction to a wound covered by dressing assembly 210 and aspirate fluid from wound; Figure 2 and 10; Paragraph 0075-0077); and
a circuit board supporting a plurality of electronic components (control unit 246 having a plurality of electronic components; Figure 10; Paragraph 0077 and 0079-0083), the plurality of electronic components comprising control circuitry configured to control operation of the negative pressure source (plurality of electronic components of the control unit 246 has processor 1310 to control negative pressure source 1360; Figure 10; Paragraph 0103), the circuit board supporting a plurality of traces electrically connecting the plurality of electronic components (control unit 246 has sensors 1320 and connected to electric circuit 1328 which is connected to processor 1310; Paragraph 0104; Figure 10 and 21A-21B), the plurality of traces comprising a first set of traces configured to transmit one or more signals (sensor 1320 has detecting circuits 2401/2402 with a first pair of electrodes 2125A and 2125B to detect a voltage and will transmit the change in voltage to processor 1310 for detecting a replacement of the collection canister; Figure 18 and 21A-B; Paragraphs 0104, 0118, and 0123-0125) and a second set of traces configured to transmit one or more analog signals (sensor 1320 has detecting circuits 2401/2402 with a second pair of electrodes 2125C and 2125D to detect a voltage and will transmit the change in voltage to processor 1310 for detecting a replacement of the collection canister; Figure 18 and 21A-B; Paragraphs 0104, 0118, and 0123-0125),
the control circuitry further configured to:
detect a degradation of an electrical signal on at least one trace of the first or second set of traces, the degradation caused by one or more of an ingress of liquid onto the circuit board or condensation (sensor 1320 can be detection circuits 2401/2402 to detect degradation of an electric signal because of short circuiting the electrodes 1325A/1325B; Paragraph 0123-0125); and
responsive to detection of the degradation of the electrical signal caused by one or more of the ingress of liquid or condensation, temporarily or permanently deactivate provision of negative pressure to the wound (shorting the electrodes 1325A/1325B of the detection circuit 2401/2402 of the sensor 1320 will notify the processor 1310 to replace/empty canister as an alarm – alarm can stop operation of pump by control unit 246; Paragraph 0080 and 0123-0125; Figure 10 and 21A-21B).
Braga does not teach the first set of traces configured to transmit one or more digital signals.
However, Tang teaches the first set of traces configured to transmit one or more digital signals (analog digital convertor 804 between the sensor and the processor; Paragraph 0025 and 0095-0098; Figure 8).
Tang and Braga are both considered to be analogous to the claimed invention because they are in the same field of sensor-based medical treatment devices. 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 Braga to incorporate the teachings of Tang to have the analog digital converter of Tang in the first set traces of Braga between the electrode and processor of Braga. This allows for the signal that is measured by the sensor to be translated to a voltage signal for the processor to detect a given status of the operation (Tang; Paragraph 0025).
Regarding claim 3, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein the circuit board supports the negative pressure source (control unit 246 supports suction pump 1360 under the same housing; Figure 10; Paragraph 0077).
Regarding claim 4, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein the ingress of liquid occurs as a result of the negative pressure source aspirating fluid from the wound (sensor 1320 can be detection circuits 2401/2402 to detect degradation of an electric signal because of short circuiting the electrodes 1325A/1325B from fluid that is aspirated from the wound; Paragraph 0104 and 0123-0125).
Regarding claim 5, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein the degradation of the electrical signal is caused by a short circuit as a result of the one or more of the ingress of liquid or condensation (sensor 1320 can be detection circuits 2401/2402 to detect degradation of an electric signal because of short circuiting the electrodes 1325A/1325B from fluid that is aspirated from the wound and travels into the collection canister 242; Paragraph 0104 and 0123-0125).
Regarding claim 6, Braga in view of Tang teaches the system of claim 4. Braga further teaches wherein the degradation of the electrical signal is caused by a short circuit between two traces from the first set of traces or between a trace from the first set of traces and ground or power (electrodes 1325A-1325B/2125A-2125B of sensor 1320 is shorted from degradation; Paragraph 0104 and 0123-0125).
Regarding claim 7, Braga in view of Tang teaches the system of claim 6. Braga further teaches wherein the two traces from the first set of traces comprise portions not coated with waterproof material or the trace from the first set of traces comprises a portion not coated with waterproof material, and wherein the short circuit is formed due to liquid coming into contact with the portions not coated with waterproof material or the portion not coated with waterproof material (electrodes 1325A-1325B/2125A-2125B are not coated with waterproof material for shorting while surrounding container material is waterproof; Figure 18 and 21A-21B; Paragraph 0123-125).
Regarding claim 8, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein a trace from the second set of traces corresponds to a feedback line of the negative pressure source, and wherein the control circuitry is configured to detect the degradation of the electrical signal based at least in part on a short circuit on the feedback line (electrodes 1325A-1325B/2125A-2125B is the feedback line for negative pressure source 1360 and shorts when degradation is detected; Paragraph 0104, 0118, and 0123-125; Figure 10, 18, and 21A-21B).
Regarding claim 14, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein temporarily deactivating provision of negative pressure to the wound comprises preventing the negative pressure source from being activated to provide negative pressure to the wound for a first time period, and wherein the control circuitry is further configured to activate the negative pressure source to provide negative pressure to the wound at expiration of the first time period (control unit 246 stops operation of pump when canister replacement or clearing is needed – obvious that the replacement/cleaning of canister will resume negative pressure treatment after a first time period when alarm is resolved; Paragraph 0079-0080, 0104, and 0107; Figure 10).
Regarding claim 15, Braga in view of Tang teaches the system of claim 14. Braga further teaches wherein the first time period corresponds to a time period for clearing an error caused by one or more of the ingress of liquid or condensation onto the circuit board (control unit 246 stops operation of pump when canister replacement or clearing is needed – obvious that the replacement/cleaning of canister will resume negative pressure treatment after a first time period when alarm is resolved; Paragraph 0079-0080, 0104, and 0107; Figure 10).
Regarding claim 17, Braga in view of Tang teaches the system of claim 1. The combination of Braga in view of Tang further teaches wherein the control circuitry is further configured to detect the degradation of the electrical signal based on data obtained from one or more of: a humidity sensor; or an electronic fuse (eFuse) (Braga; electrodes 1325A, 1325B, 1325C, and 1325D senses moisture through electrical resistance; Paragraph 0104; Figure 10 and 18).
Regarding claim 19, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein the control circuitry is further configured to provide an alarm responsive to the detection of the degradation of the electrical signal (control unit 246 signals alarm when shortage is detected from processor 1310 because of need for canister emptying or replacement; Figure 10 and 18; Paragraph 0079-0080, 0104, 0118, and 0123-0125). Regarding claim 20, Braga in view of Tang teaches the system of claim 1. Braga further teaches wherein the control circuitry comprises a programmable controller configured to execute instructions that detect the degradation of the electrical signal and, responsive to detection of the degradation of the electrical signal, temporarily or permanently deactivate provision of negative pressure to the wound (controller 246 is programmable to stop treatment in response to shortage detection; Paragraph 0079-0080, 0104, 0118, and 0123-0125).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (Publication No. US 2020/0171217 A9) in view of Tang et al. (Publication No. US 2009/0229606 A1), as applied to claim 1 above, and further in view of Quintanar (Publication No. US 2020/0086013 A1).
Regarding claim 2, Braga in view of Tang teaches the system of claim 1. The combination of Braga in view of Tang does not teach further comprising the wound dressing, wherein at least one of the negative pressure source or the circuit board is at least partially supported by the wound dressing.
However, Quintanar further teaches further comprising the wound dressing, wherein at least one of the negative pressure source or the circuit board is at least partially supported by the wound dressing (user interface 12D with the control circuitry 12A is mounted on the apparatus 11 with the wound dressing 13; Paragraph 0022-0023; Figure 1 and 2A-2B).
Quintanar and Braga in view of Tang are both considered to be analogous to the claimed invention because they are in the same field of negative pressure therapy system. 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 Braga in view of Tang to incorporate the teachings of Quintanar to have the control circuitry of Braga with a user interface mounted on the wound dressing, as taught by Quintanar. This allows for the user to directly control the negative pressure apparatus with a single element (Quintanar; Paragraph 0020-0021).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (Publication No. US 2020/0171217 A9) in view of Tang et al. (Publication No. US 2009/0229606 A1), as applied to claim 1 above, and further in view of Michna et al. (Publication No. US 2020/0153233 A1).
Regarding claim 9, Braga in view of Tang teaches the system of claim 1. The combination of Braga in view of Tang does not teach wherein a trace from the second set of traces is part of a circuitry configured to detect excessive temperature, and wherein the control circuitry is configured to detect the degradation of the electrical signal by determining that the circuitry configured to detect excessive temperature has made an incorrect detection of excessive temperature.
However, Michna teaches wherein a trace from the second set of traces is part of a circuitry configured to detect excessive temperature (circuit 106 with passive temperature sensors 108; Figure 1; Paragraph 0018), and wherein the control circuitry is configured to detect the degradation of the electrical signal by determining that the circuitry configured to detect excessive temperature has made an incorrect detection of excessive temperature (when threshold of temperature sensor is exceeded, it is an indication of a short circuit; Abstract; Paragraph 0015, 0034, and 0043).
Michna and Braga in view of Tang are both considered to be analogous to the claimed invention because they are in the same field of sensor-based electronic circuitry. 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 Braga in view of Tang to incorporate the teachings of Michna to have the temperature sensors circuitry of Michna in the second set of traces of Braga in view of Tang. This allows for an effective monitoring of short circuiting without impacting the design of the device (Michna; Paragraph 0015 and 0036).
Regarding claim 10, Braga in view of Tang and Michna teaches the system of claim 9. The combination of Braga in view of Tang and Michna further teaches wherein the control circuitry is configured to determine that the circuitry configured to detect excessive temperature has made the incorrect detection of excessive temperature based on processing temperature detected by an additional temperature sensor (Michna; detection circuit detects abnormal increase in temperature by comparing sensor output of higher temperature with other temperature sensors through the comparator circuits; Figure 4; Paragraph 0023-0025 and 0037-0041).
Claim(s) 11-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (Publication No. US 2020/0171217 A9) in view of Tang et al. (Publication No. US 2009/0229606 A1), as applied to claim 1 above, and further in view of Horai et al. (Publication No. US 2020/0064409 A1).
Regarding claim 11, Braga in view of Tang teaches the system of claim 1. Braga further teaches further comprising at least one battery (device has battery as a power source; Paragraph 0099 and 0121). The combination of Braga in view of Tang does not teach wherein the control circuitry is further configured to drain the at least one battery responsive to the detection of the degradation of the electrical signal.
However, Horai teaches wherein the control circuitry is further configured to drain the at least one battery responsive to the detection of the degradation of the electrical signal (when short circuit is determined, battery is discharged to the external resistor; Figure 1 and 3; Paragraph 0044-0046).
Horai and Braga in view of Tang are both considered to be analogous to the claimed invention because they are in the same field of battery operated electronic circuitry. 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 Braga in view of Tang to incorporate the teachings of Horai to have the control circuitry of Braga in view of Tang to have the external resistor and switch with the control unit instruction of battery drainage of Horai to be connected with the control circuitry of Braga in view of Tang when the detection of degradation is detected by the circuitry of Braga in view of Tang. This allows for the enhancement of safety by draining power from the defective device (Horai; Paragraph 0051).
Regarding claim 12, Braga in view of Tang and Horai teaches the system of claim 11. The combination of Braga in view of Tang and Horai further teaches wherein the plurality of electronic components further comprise a resistor network and a switch (Horai; switch 140a and external resistor 130; Paragraph 0027 and 0044-0046; Figure 1 and 3), and wherein the control circuitry is configured to open the switch and drain the at least one battery through the resistor network (Horai; Paragraph 0027 and 0044-0046).
Regarding claim 18, Braga in view of Tang teaches the system of claim 1. The combination of Braga in view of Tang does not teach wherein the control circuitry is configured to temporarily or permanently deactivate provision of negative pressure by one or more of: blowing a fuse; opening the fuse; opening a switch; or opening a relay.
However, Horai further teaches wherein the control circuitry is configured to temporarily or permanently deactivate provision of negative pressure by one or more of: blowing a fuse; opening the fuse; opening a switch; or opening a relay (when short circuit is determined, battery is discharged to the external resistor 130 by switch 140a; Figure 1 and 3; Paragraph 0027 and 0044-0046).
Horai and Braga in view of Tang are both considered to be analogous to the claimed invention because they are in the same field of battery operated electronic circuitry. 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 Braga in view of Tang to incorporate the teachings of Horai to have the control circuitry of Braga in view of Tang to have the external resistor and switch with the control unit instruction of battery drainage of Horai to be connected with the control circuitry of Braga in view of Tang when the detection of degradation is detected by the circuitry of Braga in view of Tang. This allows for the enhancement of safety by draining power from the defective device (Horai; Paragraph 0051).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (Publication No. US 2020/0171217 A9) in view of Tang et al. (Publication No. US 2009/0229606 A1) and Horai et al. (Publication No. US 2020/0064409 A1), as applied to claim 11 above, and further in view of Kaito et al. (Publication No. US 2001/0044044 A1).
Regarding claim 13, Braga in view of Tang and Horai teaches the system of claim 11. The combination of Braga in view of Tang and Horai further teaches wherein the plurality of electronic components further comprise a switch (Horai; when short circuit is determined, battery is discharged by switch 140a; Figure 1 and 3; Paragraph 0027 and 0044-0046). The combination of Braga in view of Tang and Horai does not teach wherein the plurality of electronic components further comprise a conductive plane.
However, Kaito teaches wherein the plurality of electronic components further comprise a conductive plane (conductive plate 3b with resistor R allows for the discharge of battery; Paragraph 0027-0028; Figure 4).
Kaito and Braga in view of Tang and Horai are both considered to be analogous to the claimed invention because they are in the same field of battery operated electronic circuitry. 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 Braga in view of Tang and Horai to incorporate the teachings of Horai to have the control circuitry with the external resistor and switch of Braga in view of Tang and Horai to have the conductive plate of Kaito. This allows for the redirection of the electrical charge from the battery to decrease the temperature of the device (Kaito; Paragraph 0011 and 0028).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Braga et al. (Publication No. US 2020/0171217 A9) in view of Tang et al. (Publication No. US 2009/0229606 A1), as applied to claim 1 above, and further in view of Askem et al. (Publication No. US 2019/0358372 A1).
Regarding claim 16, Braga in view of Tang teaches the system of claim 1. The combination of Braga in view of Tang does not teach wherein permanently deactivating provision of negative pressure to the wound comprises preventing the negative pressure source from being activated to provide negative pressure to the wound.
However, Askem teaches wherein permanently deactivating provision of negative pressure to the wound comprises preventing the negative pressure source from being activated to provide negative pressure to the wound (non-recoverable error is the state where the negative pressure source cannot be activated when a short circuit is detected; Paragraph 0235 and 0237).
Askem and Braga in view of Tang are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy device. 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 Braga in view of Tang to incorporate the teachings of Askem to have the control circuitry of Braga in view of Tang to have the permanent deactivation mode of Askem when the detection of degradation is detected by the circuitry of Braga in view of Tang. This allows for the deactivation of the device when electrical circuit defects arise (Askem; Paragraph 0237).
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
/KAI H WENG/Primary Examiner, Art Unit 3781
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