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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
Response to Amendment
The amendment filed 12/30/2025 has been entered. Claims 1, 7-8, and 10 have been amended. Claims 9, 18, 20 and 24 are cancelled. Claims 1-8, 10-17, 19, 21-23, 25-26 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on Long ‘216 for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made citing Robinson for the teaching of a non-programmable electronic control circuitry that is hardwired.
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.
Claims 1-4, 13-14, 16-17, 19 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (Pub. No.: US 2012/0016323 A1) in view of Long et al. (Pub. No.: US 2021/0077670 A1), hereinafter Long ‘670.
Regarding claim 1, Robinson discloses (fig. 1, 6) a negative pressure wound therapy system (reduced-pressure treatment system assembly 100) comprising:
A negative pressure source (pump 180) configured to provide negative pressure to a wound of a patient (tissue site 110) covered by a wound dressing (dressing assembly 102);
A first sensor configured to measure a temperature of at least a first portion of the negative pressure wound therapy system (¶ 0048); and
A non-programmable electronic control circuitry that is hardwired (control unit 10 which may be analog, ¶ 0048) and configured to allow or disallow the negative pressure source to provide negative pressure to the wound responsive to the temperature measured by the first sensor (¶ 0048).
Robinson fails to disclose a second sensor configured to measure a temperature of at least one of a patient or at least a second portion of the negative pressure wound therapy system; a programmable controller configured to control operation of the negative pressure source responsive to the temperature measured by the second sensor; and the programmable controller configured to control operation of the negative pressures source independently of the non-programmable electronic control circuitry.
Long ‘670 teaches (fig. 1, 4) a negative pressure wound therapy system (100, ¶ 0042) and thus in the same field of endeavor, comprising:
A negative pressure source (104) configured to provide negative pressure to a wound of a patient covered by a wound dressing (dressing 102) (¶ 0043);
A second sensor (pressure sensor 416) configured to measure a temperature of at least at least one of the patient or at least a second portion of the negative pressure system (a temperature sensor can be included as a component of the pressure sensor 416, ¶ 0085-¶ 0086); and
A programmable controller (controller 110) configured to control operation of the negative pressure source (¶ 0062) responsive to the temperature measured by the second sensor (¶ 0100); the second sensor and the programmable controller configured to detect flow characteristics of the system and control the negative pressure source based on the flow characteristics (¶ 0100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Robinson such that it includes the second sensor and programmable controller of Long ‘670, in order to detect flow characteristics of the system and control the negative pressure source based on the flow characteristics (Long ‘670¶ 0100).
Accordingly, Robinson in view of Long ‘670 disclose that the programmable controller is configured to control operation of the negative pressure source independently of the non-programmable electronic control circuitry, as the non-programmable electronic control circuitry relies on controlling the negative pressure source based on the first sensor (Robinson ¶ 0048) and the controller relies on controlling the negative pressure source based on the second sensor (Long ‘670, ¶ 0100).
Regarding claim 2, Robinson in view of Long ‘670 fail to disclose wherein the programmable controller is configured to reduce activity of the negative pressure source responsive to temperature measured by the second sensor satisfying a second temperature threshold that is lower than a first temperature threshold and not satisfying the first temperature threshold.
However, Long ‘670 teaches that if a blockage state is identified, the temperature data slowly increases and the activity of the negative pressure source is reduced (¶ 0115). Thus, a temperature associated with the blockage state could be the second temperature threshold. Long ‘670 further discloses an increased temperature can be an indication that the wound is infected (¶ 0122). Thus, a temperature associated with an infection can be the first temperature threshold.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Robinson in view of Long ‘670 such that the programmable controller is configured to reduce activity of the negative pressure source responsive to temperature measured by the second sensor satisfying a second temperature threshold that is lower than a first temperature threshold and not satisfying the first temperature threshold, in order to shut down the pump such that the blockage can be removed (Long ‘670, ¶ 0115).
Regarding claim 3, Robinson in view of Long ‘670 disclose wherein reducing activity of the negative pressure source comprises lowering a duty cycle of the negative pressure source (Long ‘670, the controller may be programmed to adjust the pump duty cycle, ¶ 0100).
Regarding claim 4, Robinson discloses the wound dressing (102), wherein the negative pressure source is at least partially supported by the wound dressing (¶ 0016, fig. 1).
Regarding claim 13, Robinson in view of Long ‘670 disclose wherein the second sensor comprises a pair of sensors (Long ‘670, pressure sensor 416 can include a temperature sensor, ¶ 0085), wherein the programmable controller is configured to determine a temperature of at least one of the negative pressure source or another component of the negative pressure wound therapy system based on a difference between measurements of the first and second sensors of the pair of sensors (Long ‘670, ¶ 0091, ¶ 0116).
Regarding claim 14, Robinson in view of Long ‘670 disclose wherein the first and second sensors of the pair of sensors are configured to measure pressure and temperature (Long ‘670, ¶ 0085).
Regarding claim 16, Robinson in view of Long ‘670 discloses wherein the programmable controller is configured to control operation of the negative pressure source responsive to temperature measured by the at least second sensor by: deactivating the negative pressure source responsive to the temperature measured by the second sensor satisfying a first temperature threshold indicative of unsafe operation (Locke ‘670, in a blockage state, the temperature increases and the pump is shut down ¶ 0115)
Regarding claim 17, the limitation of reducing the activity of the negative pressure source is optional to claim 16 from which claim 17 depends. Thus, such limitation of “wherein reducing the activity of the negative pressure source comprises reducing a duty cycle of the negative pressure source” is disclosed by Robinson in view of Long ‘670.
Regarding claim 19, Robinson in view of Long ‘670 discloses wherein the programmable controller is configured to disable activation of the negative pressure source responsive to determination that the temperature measured by at least one of the first sensor or the second sensor satisfies a temperature threshold indicative of unsafe operation (Locke ‘670, in a blockage state, the temperature increases and the pump is shut down ¶ 0115).
Regarding claim 22, Robinson in view of Long ‘670 discloses wherein the second sensor is configured to measure temperature of a patient (Long ‘670, ¶ 0086), and wherein the programmable controller is configured to deactivate the negative pressure source responsive to determination that the temperature measured by the second sensor satisfies a temperature threshold indicative of high patient temperature (Long ‘670 ¶ 0106).
Regarding claim 23, Robinson in view of Long ‘670 discloses wherein the programmable controller is configured to execute instructions to control operation of the negative pressure source responsive to temperature measured by the second sensor (Long ‘670, ¶ 0100).
Claim(s) 5-6, 21 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Long ‘670, as applied to claim 1 above, and further in view of Long et al. (Pub. No.: US 2021/0060216 A1), hereinafter Long ‘216.
Regarding claim 5, Robinson in view of Long ‘670 fail to disclose wherein the temperature measured by the first sensor is indicative of a temperature of the negative pressure source.
Long ‘216 teaches (fig. 2-3) a negative pressure wound therapy system (100, ¶ 0038), and thus in the same field of endeavor comprising:
A negative pressure source (pump 120) configured to provide negative pressure to a wound (wound site 106) of a patient covered by a wound dressing (¶ 0038-¶ 0039); and
A first sensor (temperature 124) configured to measure a temperature of at least a first portion of the negative pressure wound therapy system (¶ 0049);
Wherein the temperature measured by the first sensor is indicative of a temperature of the negative pressure source (¶ 0049) which can further be indicative of the negative pressure source being susceptible to malfunctions (¶ 0035).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first sensor of Robinson in view of Long ‘670 such that the temperature measured by the first sensor is indicative of a temperature of the negative pressure source, as taught by Long ‘216, in order to determine whether the negative pressure source is susceptible to malfunctions (Long ‘216 ¶ 0035).
Regarding claim 6, Robinson in view of Long ‘670 fail to disclose the non-programmable electronic control circuitry is configured to deactivate the negative pressure source responsive to a determination that the temperature measured by the first sensor satisfies a temperature threshold indicative of unsafe operation.
Long ‘216 teaches (fig. 2-3) a negative pressure wound therapy system (100, ¶ 0038), and thus in the same field of endeavor comprising:
A negative pressure source (pump 120) configured to provide negative pressure to a wound (wound site 106) of a patient covered by a wound dressing (¶ 0038-¶ 0039); and
A first sensor (temperature 124) configured to measure a temperature of at least a first portion of the negative pressure wound therapy system (¶ 0049); and
An electronic control circuitry (state monitor 162) configured to allow or disallow the negative pressure source to provide negative pressure to the wound responsive to temperature measured by the second sensor (the state monitor 162 determines whether a state of the pump indicates that the pump is overheating and allows the pump controller to modify control of the pump, ¶ 0063);
Wherein the electronic control circuitry is configured to deactivate the negative pressure source responsive to a determination that the temperature measured by the first sensor satisfies a temperature threshold indicative of unsafe operation (¶ 0087) in order to prevent overheating or other undesired conditions of the negative pressure source (¶ 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the non-programmable electronic control circuitry of Robinson in view of Long ‘670 such that is configured to deactivate the negative pressure source responsive to a determination that the temperature measured by the first sensor satisfies a temperature threshold indicative of unsafe operation, as taught by Long ‘216, in order to prevent overheating or other undesired conditions of the negative pressure source (Long ‘216, ¶ 0063).
Regarding claim 21, Robinson in view of Long ‘670 fail to disclose a switch configured to permit activation of the negative pressure source, and wherein the switch is configured to be deactivated responsive to a determination that the temperature measured by at least one of the first sensor or the second sensor satisfies a temperature threshold indicative of unsafe operation.
Long ‘216 teaches (fig. 2-3) a negative pressure wound therapy system (100, ¶ 0038), and thus in the same field of endeavor comprising:
A negative pressure source (pump 120) configured to provide negative pressure to a wound (wound site 106) of a patient covered by a wound dressing (¶ 0038-¶ 0039); and
A first sensor (temperature 124) configured to measure a temperature of at least a first portion of the negative pressure wound therapy system (¶ 0049); and
An electronic control circuitry (state monitor 162) configured to allow or disallow the negative pressure source to provide negative pressure to the wound responsive to temperature measured by the second sensor (the state monitor 162 determines whether a state of the pump indicates that the pump is overheating and allows the pump controller to modify control of the pump, ¶ 0063); and
A switch (pump controller 152) configured to permit activation of the negative pressure source (¶ 0056), and wherein the switch is configured to be deactivated responsive to a determination that the temperature measured by at least one of the first sensor or the second sensor satisfies a temperature threshold indicative of unsafe operation (¶ 0087) in order to prevent overheating or other undesired conditions of the negative pressure source (¶ 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Robinson in view of Long ‘670 such that it comprises a switch configured to permit activation of the negative pressure source, and wherein the switch is configured to be deactivated responsive to a determination that the temperature measured by at least one of the first sensor or the second sensor satisfies a temperature threshold indicative of unsafe operation, as taught by Long ‘216 in order to prevent overheating or other undesired conditions of the negative pressure source (Long ‘216, ¶ 0063).
Regarding claim 25, Robinson discloses wherein the non-programmable control circuitry comprises only analog circuitry (¶ 0048).
Robinson in view of Long ‘670 fail to disclose that the non-programmable control circuitry is configured to allow or disallow provision of the negative pressure to the wound.
Long ‘216 teaches (fig. 2-3) a negative pressure wound therapy system (100, ¶ 0038), and thus in the same field of endeavor comprising:
A negative pressure source (pump 120) configured to provide negative pressure to a wound (wound site 106) of a patient covered by a wound dressing (¶ 0038-¶ 0039); and
A first sensor (temperature 124) configured to measure a temperature of at least a first portion of the negative pressure wound therapy system (¶ 0049); and
An electronic control circuitry (state monitor 162) configured to allow or disallow the negative pressure source to provide negative pressure to the wound responsive to temperature measured by the second sensor (the state monitor 162 determines whether a state of the pump indicates that the pump is overheating and allows the pump controller to modify control of the pump, ¶ 0063); and
Wherein the electronic control circuitry comprises is configured to solely allow or disallow provision of the negative pressure to the wound (¶ 0086-¶ 0087) in order to prevent overheating or other undesired conditions of the negative pressure source (¶ 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronic control circuitry of Robinson in view of Long ‘670 such that it is configured to allow or disallow provision of negative pressure to the wound, as taught by Long ‘216, in order to prevent overheating or other undesired conditions of the negative pressure source (Long ‘216 ¶ 0063).
Regarding claim 26, Robinson in view of Long ‘670 fail to disclose wherein the programmable controller is configured to determine that the first sensor or the second sensor is malfunctioning based on a determination that output of one of the first or second sensor but not the other indicates that a temperature threshold indicative of unsafe operation has been satisfied.
Long ‘216 teaches (fig. 2-3) a negative pressure wound therapy system (100, ¶ 0038), and thus in the same field of endeavor comprising:
A negative pressure source (pump 120) configured to provide negative pressure to a wound (wound site 106) of a patient covered by a wound dressing (¶ 0038-¶ 0039); and
A first sensor (temperature 124) configured to measure a temperature of at least a first portion of the negative pressure wound therapy system (¶ 0049); and
Wherein a temperature threshold of between 50 and 70 degrees C indicative of a temperature of the pump overheating (¶ 0064). Thus, a temperature measured by the first temperature sensor of over 70 degrees C can be indicative of the first sensor malfunctioning.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to program the programmable controller of Robinson in view of Long ‘670 such that it is configured to determine that the first sensor is malfunctioning based on a determination that output of the first indicates that a temperature threshold indicative of unsafe operation has been satisfied, as suggested by Long ‘216, in order to indicate to a user that the system is no longer operating as desired.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Long ‘670, as applied to claim 1 above, and further in view of Harrison et al. (Pub. No.: US 2020/0338243 A1).
Regarding claim 11, Robinson in view of Long ‘670 fail to disclose a power source configured to provide power at least to the negative pressure source and a boost converter configured to increase power provided by the power source and provide the increased power to the negative pressure source, and wherein the first sensor is configured to measure temperature of the boost converter.
Harrison teaches (fig. 2B) a negative pressure wound therapy system (abstract) and thus in the same field of endeavor, comprising: a negative pressure source (pump 272), and a power source (batteries 268) configured to provide power at least to the negative pressure source (pump 272) (¶ 0072) and a boost converter (¶ 0110) configured to increase power provided by the power source and provide the increased power to the negative pressure source (¶ 0110), and wherein a sensor is configured to measure a temperature of the boost converter (the power source includes the boost converter ¶ 0110 which is provided on a flexible circuit board 276 which may include a temperature sensor ¶ 0073) in order to allow for increased output to the power source of the negative pressure source (¶ 0110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of L Robinson in view of Long ‘670 such that it includes a power source configured to provide power at least to the negative pressure source and a boost converter configured to increase power provided by the power source and provide the increased power to the negative pressure source, as taught by Harrison, in order to allow for increased output to the power source of the negative pressure source (Harrison ¶ 0110).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first sensor of Robinson in view of Long ‘670 such that it is configured to measure temperature of the boost converter, as taught by Harrison, in order to measure a temperature of the boost converter to determine whether the power source is overheated.
Regarding claim 12, Robinson in view of Long ‘670 and further in view of Harrison disclose wherein the first sensor is positioned proximal to the boost converter (Harrison, the power source includes the boost converter ¶ 0110 which is provided on a flexible circuit board 276 which may include a temperature sensor ¶ 0073).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Long ‘670, as applied to claim 13 above, and further in view of Shelton, IV et al. (Pub. No.: US 2019/0201594 A1).
Regarding claim 15, Robinson in view of Long ‘670 fail to disclose wherein the first sensor of the pair of sensors is positioned at an inlet of the negative pressure source and a second sensor of the pair of sensors is positioned at an exhaust of the negative pressure source.
Shelton teaches (fig. 6) a system (surgical evacuation system 50400) comprising a negative pressure source (pump 50450) and thus in the same field of endeavor, the system comprising a pair of sensors, wherein a first sensor of the pair of sensors is positioned at an inlet of the negative pressure source and a second sensor of the pair of sensors is positioned at an exhaust of the negative pressure source (¶ 0318).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second sensor of Robinson in view of Long ‘670 such that the first sensor of the pair of sensors is positioned at an inlet of the negative pressure source and a second sensor of the pair of sensors is positioned at an exhaust of the negative pressure source, as taught by Shelton, in order to monitor the inlet and exhaust temperature of the negative pressure source to determine whether the negative pressure source is overheating.
Allowable Subject Matter
Claims 7-8 and 10 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.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 7 recites “wherein the non-programmable electronic control circuitry comprises an analog comparator configured to output determination that the temperature measured by the first sensor satisfies the temperature threshold indicative of unsafe operation, the comparator accepting as a first input the temperature measured by the first sensor and as a second input the temperature threshold”. The closest prior art of record is Robinson which discloses a non-programmable electronic control circuitry. While Robinson discloses that the non-programmable electronic control circuitry is formed using analog electronic components, Robinson fails to explicitly disclose an analog comparator. Long ‘216 discloses a comparator configured to output the determination that that the temperature measured by the first sensor satisfies the temperature threshold indicative of unsafe operation, the comparator accepting as a first input the temperature measured by the first sensor and as a second input the temperature threshold (¶ 0060-¶ 0064). However, Long ‘216 fails to disclose that the comparator is analog. A person having ordinary skill in the art before the effective filing date of the claimed invention would not have found it obvious to modify the comparator of Long ‘216 such that it is analog as such modification would require a substantial reconstruction of the non-programmable electronic control circuitry of Robinson.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bogie et al. (Pub. No.: US 2020/0061379 A1) discloses a dressing comprising a temperature sensor.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781