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 .
Response to Arguments
Applicant's arguments filed 09/03/2025 have been fully considered but they are not persuasive.
Regarding the argument that Locke does not disclose “a flow rate sensor having an input fluidly coupled between the pump and the porous pad”, the argument is unpersuasive. Paragraph 0051 reads “a flow sensor (not shown) that directly measures the flow rate of air between the regulator 118 (including the regulator 218 and the regulator 418) and tissue interface 108, i.e., the flow rate (FR)”. As seen in Figure 1, a fluid connection is present between the pump 112/regulator 118 and the tissue interface 108/cover 106. As stated in the Non-Final Rejection, the flow rate sensor is a differential processor, requiring an input that is fluidly coupled, or “directly measur[ing]” as seen in Locke - Paragraph 0051, between the fluid connection of the pump and the pad for pressure measurement.
Regarding the argument that Locke does not disclose “the controller is configured to… generate a low-leak signal at the output of the controller when the flow rate (FR) is less than the minimum flow rate (MinFR)”, the argument is unpersuasive. Paragraph 0051 recites that the flow rate sensor is used to detect the flow rate and “provides some indication of the extent to which the dressing 102 or other components of the negative pressure system 100 might be leaking to reduce the pressure at the tissue site below the desired pressure targeted for therapy”, such as the low leakage condition, where the flow rate is less than a given threshold, or a low flow rate. Paragraph 0051 further reads ”lower flow rate (FR) might indicate that the dressing 115 or other components of the system 100 are considered to be in a more efficient "low leakage condition" requiring the pump of the negative pressure source 104 to run intermittently or less frequently”. This indicates that the “low leakage condition” is a signal to the system to control the pump to run less often (Paragraph 0049 and 0051).
Regarding the argument that Locke does not teach “a regulator coupled to the output of the controller and adapted to increase the flow rate (FR) by increasing the leakage into the therapeutic environment in response to the occurrence of a low-leak signal”, the argument is not persuasive. Paragraph 0049 of Locke reads “controller 110 may be programmed to control the solenoid valve 419 to vary the flow rate during the predetermined flow-control intervals”. This indicates that the flow rate can be increased or decreased by the controller in communication with the regulator, based on a given signal, such as a low leakage condition (Paragraph 0049-0051). Furthermore, the regulator of Locke would be fully capable of, or “adapted to”, increasing a flow rate in response to the “low leakage condition” since the regulator is controlled by the controller that monitors the flow rate of the system (Paragraph 0041-0042, 0045-0046, 0049-0051; Claims 11-18).
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) 1-3, 5-11, 14-15, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Locke et al. (Publication No. WO 2019/036169 A1).
Regarding claim 1, Locke discloses a system for promoting healing of a wound at a tissue site (system 100; Figure 1; Paragraph 0021; Claim 1), comprising:
a dressing including a porous pad configured to be positioned at the tissue site and adapted to be covered by a drape to form a therapeutic environment separated from the external environment for maintaining a wound pressure (WP) (dressing 102 has a tissue interface 108, where the tissue interface is porous and is in contact with the tissue site, and cover 106 covers over the tissue interface to form a therapeutic environment and maintain a wound pressure; Paragraph 0021-0022, 0038, and Paragraph 0051; Figure 1);
a negative-pressure source including a pump adapted to generate a pump pressure (PP) and further adapted to be fluidly coupled to the porous pad for applying negative pressure to the tissue site (negative pressure source 104 that is a pump and is fluidly connected to the tissue interface 108 to deliver the negative pressure to the tissue site; Paragraph 0030-0031 and 0051; Figure 1);
a flow rate sensor having an input fluidly coupled between the pump and the porous pad and an output for providing a flow-rate signal representing a flow rate (FR) of fluids indicative of leakage between the pump and the porous pad (flow rate sensor can be a differential processor that measure the time rate of change between the pressure that the tissue site and the pump and can output a signal indicative of a high leak or low leak condition; Paragraph 0051; Figure 1);
a controller having an input coupled to the output of the flow rate sensor and an output, wherein the controller is configured to (i) determine a flow rate (FR) based on the flow-rate signal, (ii) compare the flow rate (FR) to a minimum flow rate (MinFR), and (iii) generate a low-leak signal at the output of the controller when the flow rate (FR) is less than the minimum flow rate (MinFR) (controller 110 has an input from flow rate sensor to determine the flow rate and compare the flow rate with a pre-determined flow rate, such as a detection of a low leakage condition; Paragraph 0049 and 0051; Figure 1); and
a regulator coupled to the output of the controller and adapted to increase the flow rate (FR) by increasing the leakage into the therapeutic environment in response to the occurrence of a low-leak signal (regulator 118 is connected to the controller 110 and can increase flow rate when low-leak is detected; Paragraph 0040-0041, 0045-0046, and 0049-0051, Claims 11-18; Figure 1).
Regarding claim 2, Locke discloses the system of claim 1. Locke further discloses wherein the flow rate sensor comprises a first pressure sensor having a first input for sensing the pump pressure (PP) and a first output for providing a signal indicative of the pump pressure (PP), and a second pressure sensor having in a second input for sensing the wound pressure (WP) and a second output for providing a signal indicative of the wound pressure (WP) (two pressure sensors to measure two pressures, one at the tissue site and the other at the pump – “The flow sensor may be, for example, a flow-meter or a differential processor for computing the time rate of change in the difference between the pressure at the tissue site, i.e., the wound pressure (WP), and the pressure at the negative pressure source 104, i.e., the pump pressure (PP)”; Paragraph 0040-0041 and 0051), and wherein the controller is electrically coupled to the first output of the first pump and the second output of the second pump and is further configured to determine the flow rate (FR) based on the difference between pump pressure (PP) and the wound pressure (WP) (flow rate can be calculated by difference in pressures at the two locations; Paragraph 0040-0041 and 0051).
Regarding claim 3, Locke discloses the system of claim 1. Locke further discloses wherein the regulator is configured to increase the leakage by venting gases from the external environment to the therapeutic environment (regulator 118 can pull air 115 from external to therapeutic environment to increase leakage; Figure 1; Paragraph 0041, 0045-0046, and 0050-0051).
Regarding claim 5, Locke discloses the system of claim 1. Locke further discloses wherein the leakage has a first leakage threshold and a second leakage threshold (“a fairly high leakage rate (LR) of approximately 300cc/min and a fairly low leakage rate (LR) of approximately 50cc/min” – first and second leakage threshold is the high and low leak conditions; Paragraph 0050-0051).
Regarding claim 6, Locke discloses the system of claim 3. Locke further discloses wherein the regulator is configured further to increase the leakage from zero to a first leakage threshold (regulator 118 is fully capable of increasing leakage from zero to a first leakage threshold – regulator is a valve that can be programmed to vary the flow rate; Paragraph 0048-0051).
Regarding claim 7, Locke discloses the system of claim 6. Locke further discloses wherein the regulator is configured further to increase the leakage by venting gases at a fixed rate (Paragraph 0060 – predetermined increase in leakage to prevent formation of blockages; Claim 12).
Regarding claim 8, Locke discloses the system of claim 6. Locke further discloses wherein the regulator is configured further to increase the leakage by venting gases at a variable rate (Paragraph 0008 and 0048-0051; Claim 13).
Regarding claim 9, Locke discloses the system of claim 8. Locke further discloses wherein the regulator is configured further to vary the amplitude of the variable rate (amplitude of the variable rate is increasing the flow rate which can be done by the regulator; Paragraph 0008 and 0048-0051; Claim 13).
Regarding claim 10, Locke discloses the system of claim 8. Locke further discloses wherein the regulator is configured further to vary the frequency of the variable rate (Paragraph 0062 – controller may be programmed to activate the valve more frequently for longer periods of time).
Regarding claim 11, Locke discloses the system of claim 8. Locke further discloses wherein the regulator is configured further to vary the duty cycle of the variable rate (Paragraph 0062 – controller may be programmed to activate the valve more frequently for longer periods of time until the change in pressure increases to an acceptable level, equivalent to increasing the duty cycle of the regulator).
Regarding claim 14, Locke discloses the system of claim 1. Locke further discloses wherein the minimum flow rate (MinFR) comprises two or more target flow rates (two thresholds that can be compared with the current flow rate, the high leak rate and the low leak rate conditions; Paragraph 0051).
Regarding claim 15, Locke discloses the system of claim 14. Locke further discloses wherein the controller is configured further to adjust the flow rate (FR) based on a first target flow rate and a second target flow rate (Paragraph 0008 – regulator can control the flow rate over time based on desired therapy).
Regarding claim 24, Locke discloses a system for promoting healing of a wound at a tissue site (system 100; Figure 1; Paragraph 0021; Claim 1), comprising:
a dressing including a porous pad configured to be positioned at the tissue site and adapted to be covered by a drape to form a therapeutic environment separated from the external environment for receiving negative pressure (dressing 102 has a tissue interface 108, where the tissue interface is porous and is in contact with the tissue site, and cover 106 covers over the tissue interface to form a therapeutic environment and maintain a wound pressure; Paragraph 0021-0022, 0038, and Paragraph 0051; Figure 1);
a flow rate sensor having an input fluidly coupled to the porous pad and an output for providing a flow-rate signal representing a flow rate (FR) of fluids proximate the porous pad (flow rate sensor can be a differential processor that measure the time rate of change between the pressure that the tissue site and the pump and can output a signal indicative of a high leak or low leak condition; Paragraph 0051; Figure 1);
a controller coupled to the output of the flow rate sensor and configured to (i) determine a flow rate (FR) based on the flow-rate signal, (ii) compare the flow rate (FR) to a minimum flow rate (MinFR), and (iii) generate a low-leak signal when the flow rate (FR) is less than the minimum flow rate (MinFR) (controller 110 has an input from flow rate sensor to determine the flow rate and compare the flow rate with a pre-determined flow rate, such as a detection of a low leakage condition; Paragraph 0049 and 0051; Figure 1); and
a regulator coupled to the controller and adapted to increase the flow rate (FR) by increasing the leakage into the therapeutic environment in response to the occurrence of a low-leak signal (regulator 118 is connected to the controller 110 and can increase flow rate when low-leak is detected; Paragraph 0040-0041, 0045-0046, and 0049-0051, Claims 11-18; Figure 1).
Regarding claim 25, Locke discloses the system of claim 24. Locke further discloses wherein the flow rate sensor comprises a first pressure sensor for sensing a first pressure and a second pressure sensor for sensing a second pressure (two pressure sensors to measure two pressures, one at the tissue site and the other at the pump – “The flow sensor may be, for example, a flow-meter or a differential processor for computing the time rate of change in the difference between the pressure at the tissue site, i.e., the wound pressure (WP), and the pressure at the negative pressure source 104, i.e., the pump pressure (PP)”; Paragraph 0040-0041 and 0051), and wherein the controller is electrically coupled to the first sensor and the second sensor and is further configured to determine the flow rate (FR) based on the difference between the first pressure and the second pressure (flow rate can be calculated by difference in pressures at the two locations; Paragraph 0040-0041 and 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) 18-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. WO 2019/036169 A1) in view of Francis, Jr. et al. (Publication No. US 2019/0125942 A1).
Regarding claim 18, Locke discloses the system of claim 1. Locke does not teach wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source and the controller is configured further to increase negative pressure at the wound site when the wound pressure (WP) is less than a minimum wound pressure (WPMin) by increasing power applied to the motor.
However, Francis, Jr. teaches wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source (pump 112 is connected to a motor 114 that is connected to a power source; Paragraph 0022-0023) and the controller is configured further to increase negative pressure at the wound site when the wound pressure (WP) is less than a minimum wound pressure (WPMin) by increasing power applied to the motor (controller 170 with bang-bang controller/PID controller where a pump pressure is increased to increase the wound pressure by increasing the power to the pump when the wound pressure is determined to be under the pressure threshold; Paragraph 0060-0065).
Locke and Francis, Jr. are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke to incorporate the teachings of Francis, Jr. to have the pump of Locke to be a motor pump, as taught by Francis, Jr., wherein the controller of Locke has a bang-bang controller and PID controller, as taught by Francis, Jr. This would allow for the device to automatically adjust the power to the pump based on the difference of the pressure value to a predetermined pressure value that should be delivered to the wound site (Francis, Jr.; Paragraph 0060-0065).
Regarding claim 19, Locke discloses the system of claim 1. Locke does not teach wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source and the controller is configured further to decrease negative-pressure source at the wound site when the wound pressure (WP) is greater than a maximum wound pressure (WPMax) by decreasing the power applied to the motor.
However, Francis, Jr. teaches wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source (pump 112 is connected to a motor 114 that is connected to a power source; Paragraph 0022-0023) and the controller is configured further to decrease negative-pressure source at the wound site when the wound pressure (WP) is greater than a maximum wound pressure (WPMax) by decreasing the power applied to the motor (controller 170 with bang-bang controller/PID controller where a pump pressure is decreased to decrease the wound pressure by decreasing the power to the pump when a pressure threshold of the wound pressure is exceeded; Paragraph 0060-0065).
Locke and Francis, Jr. are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke to incorporate the teachings of Francis, Jr. to have the pump of Locke to be a motor pump, as taught by Francis, Jr., wherein the controller of Locke has a bang-bang controller and PID controller, as taught by Francis, Jr. This would allow for the device to automatically adjust the power to the pump based on the difference of the pressure value to a predetermined pressure value that should be delivered to the wound site (Francis, Jr.; Paragraph 0060-0065).
Regarding claim 20, Locke discloses the system of claim 1. Locke does not teach wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source and the controller is configured further to compare the pump pressure (PP) to a target pump pressure (TPP), and to vary the power applied to the electric motor in response to the comparison for maintaining the pump pressure (PP) proximate the target pressure (TPP).
However, Francis, Jr. teaches wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source (pump 112 is connected to a motor 114 that is connected to a power source; Paragraph 0022-0023) and the controller is configured further to compare the pump pressure (PP) to a target pump pressure (TPP), and to vary the power applied to the electric motor in response to the comparison for maintaining the pump pressure (PP) proximate the target pressure (TPP) (controller 170 with bang-bang controller/PID controller where controller can automatically increase and/or decrease to adjust the wound pressure to be close to target wound pressure; Paragraph 0060-0065).
Locke and Francis, Jr. are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke to incorporate the teachings of Francis, Jr. to have the pump of Locke to be a motor pump, as taught by Francis, Jr., wherein the controller of Locke has a bang-bang controller and PID controller, as taught by Francis, Jr. This would allow for the device to automatically adjust the power to the pump based on the difference of the pressure value to a predetermined pressure value that should be delivered to the wound site (Francis, Jr.; Paragraph 0060-0065).
Regarding claim 22, Locke discloses the system of claim 1. Locke does not teach wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source and the controller is configured further to determine the flow rate (FR) by determining the time rate of change of the voltage applied to the electric motor.
However, Francis, Jr. teaches wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source (pump 112 is connected to a motor 114 that is connected to a power source; Paragraph 0022-0023) and the controller is configured further to determine the flow rate (FR) by determining the time rate of change of the voltage applied to the electric motor (Paragraph 0050-0051).
Locke and Francis, Jr. are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke to incorporate the teachings of Francis, Jr. to have the pump of Locke to be a motor pump, as taught by Francis, Jr., wherein the controller of Locke is able to calculate the flow rate based in the applied voltage to the pump, as taught by Francis, Jr. This would allow for the controller to calculate the flow rate based on the operation of the device, without the need for sensors (Francis, Jr.; Paragraph 0050-0051).
Claim(s) 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. WO 2019/036169 A1) in view of Francis, Jr. et al. (Publication No. US 2019/0125942 A1) and Muser et al. (Publication No. US 2017/0165405 A1).
Regarding claim 21, Locke discloses the system of claim 1. Locke does not teach wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source.
However, Francis, Jr. teaches wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source (pump 112 is connected to a motor 114 that is connected to a power source; Paragraph 0022-0023).
Locke and Francis, Jr. are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke to incorporate the teachings of Francis, Jr. to have the pump of Locke to be a motor pump, as taught by Francis, Jr. This would allow for the device to automatically adjust the power to the pump based on the difference of the pressure value to a predetermined pressure value that should be delivered to the wound site (Francis, Jr.; Paragraph 0060-0065).
The combination of Locke in view of Francis, Jr. does not teach the controller is configured further to determine the flow rate (FR) based on a time rate of change of the power applied to the electric motor.
However, Muser teaches the controller is configured further to determine the flow rate (FR) based on a time rate of change of the power applied to the electric motor (Paragraph 0103).
Locke in view of Francis, Jr. and Muser are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke in view of Francis, Jr. to incorporate the teachings of Muser to have the controller of Locke in view of Francis, Jr. to calculate the flow rate based on the change in power applied to the pump. This would allow for the device to indirectly measure the flow rate in the device (Muser; Paragraph 0103).
Regarding claim 23, Locke discloses the system of claim 1. Locke does not teach wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source.
However, Francis, Jr. teaches wherein the pump is coupled to a motor for driving the pump in response to the application of power from a power source (pump 112 is connected to a motor 114 that is connected to a power source; Paragraph 0022-0023).
Locke and Francis, Jr. are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke to incorporate the teachings of Francis, Jr. to have the pump of Locke to be a motor pump, as taught by Francis, Jr. This would allow for the device to automatically adjust the power to the pump based on the difference of the pressure value to a predetermined pressure value that should be delivered to the wound site (Francis, Jr.; Paragraph 0060-0065).
The combination of Locke in view of Francis, Jr. does not teach the controller is configured further to determine the flow rate (FR) by determining the time rate of change of the current drawn by the electric motor.
However, Muser teaches the controller is configured further to determine the flow rate (FR) based on a time rate of change of the current applied to the electric motor (Paragraph 0103).
Locke in view of Francis, Jr. and Muser are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy 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 Locke in view of Francis, Jr. to incorporate the teachings of Muser to have the controller of Locke in view of Francis, Jr. to calculate the flow rate based on the change in current applied to the pump. This would allow for the device to indirectly measure the flow rate in the device (Muser; Paragraph 0103).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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