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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/10/2026 has been entered.
Response to Amendment
The claim amendments and response to the restriction/election requirement, mailed on 02/10/2026, have been fully considered. Claims 1-3, 5-11, 14-15, and 18-25 are pending in this application. Claims 1-2, 9-11, and 18-25 are amended. Claims 4, 12-13, 16-17, and 26-37 are cancelled.
Response to Arguments
Applicant’s arguments with respect to the amended independent claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. More specifically, the rejection of claim 1 is now anticipated by Francis, Jr. et al. (Publication No. US 2019/0125942 A1).
Though some of the same prior art reference is re-used herein, the request for continued examination necessitated a change in the grounds of the rejection based on updated search and consideration made by the examiner.
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) 1-2, 14-15, 18-20, 22, and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francis, Jr. et al. (Publication No. US 2019/0125942 A1).
Regarding claim 1, Francis, Jr. discloses a system for promoting healing of a wound at a tissue site (system 100 for treating wound site with negative pressure; Figure 1; Paragraph 0021), comprising:
a dressing (dressing 115; Paragraph 0028; Figure 1) 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) (manifold 120 can be porous and placed at the tissue site 105 while covered by a sealing member 125 to maintain suction pressure in the therapeutic environment within the dressing, separate from the external environment; Paragraph 0028-0031; 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 (reduced pressure source 110 includes a pump 112 that generates a pump pressure (PP) that delivered pressure to the dressing and onto the tissue site; Figure 1; Paragraph 0022);
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 is pump sensor 156 and wound pressure sensor 155 to measures the difference in pressure between wound site and pump and outputs a leakage signal, where the input of the sensor 156 is fluidly coupled to conduit 130 and input of wound pressure sensor 155 is fluidly coupled through conduit 160 and connector 150 between dressing 115 and vacuum source 110 and where the output is a differential pressure signal/flow rate signal delivered to the controller 170; Paragraph 0037-0038 and 0050; Figure 1);
a controller having an input coupled to the output of the flow rate sensor and an output (controller 170 has an input of the differential pressure measurement/flow rate from sensors 155/156 and an output to the source 110; Paragraphs 0023, 0037-0038, and 0050-0051), wherein the controller is configured to (i) determine a flow rate (FR) based on the flow-rate signal (flow rate is calculated from differential pressure signal of sensors 155/156; Paragraph 0050), (ii) compare the flow rate (FR) to a minimum flow rate (MinFR) (“Hence, it is desirable to keep the bang-bang controller running during treatment sessions as much as possible for low leakage conditions such as, for example, when the flow rate (FR) is less than or equal to a fixed target flow rate (TFR) which represents a low leak condition…” – Paragraph 0066; Figure 6), 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) (Paragraph 0066 – low leak condition is detected; Figure 6); 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 an occurrence of a low-leak signal (bang-bang controller and PID controller are components of the regulator is connected to controller 170 to increase the leakage in response to a low leak signal; Figure 6 – PP3 is the low leak signal and the leakage is then increased to reach PP_max; Paragraph 0064-0066).
Regarding claim 2, Francis, Jr. discloses the system of claim 1. Francis, Jr. 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) (second pressure sensor 156 measures pump pressure; Paragraph 0038; Figure 1), 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) (first pressure sensor 155 measures wound pressure; Paragraph 0037; Figure 1), and wherein the controller is electrically coupled to the first output of the first pressure sensor and the second output of the second pressure sensor and is further configured to determine the flow rate (FR) based on the difference between pump pressure (PP) and the wound pressure (WP) (controller can calculate the flow rate from difference in pressures from the first and second sensors 155/156 outputs; Paragraph 0050).
Regarding claim 14, Francis, Jr. discloses the system of claim 1. Francis, Jr. further discloses wherein the minimum flow rate (MinFR) comprises two or more target flow rates (controller 170 have dual target flow rate; Paragraph 0069).
Regarding claim 15, Francis, Jr. discloses the system of claim 14. Francis, Jr. 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 (user can set two target flow rates to determine low leak status and adjust flow rate; Paragraph 0069).
Regarding claim 18, Francis, Jr. discloses the system of claim 1. Francis, Jr. further discloses wherein the pump is coupled to a motor for driving the pump in response to an 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 tissue 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).
Regarding claim 19, Francis, Jr. discloses the system of claim 1. Francis, Jr. further discloses wherein the pump is coupled to a motor for driving the pump in response to an 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 tissue 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).
Regarding claim 20, Francis, Jr. discloses the system of claim 1. Francis, Jr. further discloses wherein the pump is coupled to a motor for driving the pump in response to an 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 motor in response to the comparison for maintaining the pump pressure (PP) proximate the target pump 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).
Regarding claim 22, Francis, Jr. discloses the system of claim 1. Francis, Jr. further discloses wherein the pump is coupled to a motor for driving the pump in response to an 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 a time rate of change of a voltage applied to the motor (Paragraph 0050-0051).
Regarding claim 24, Francis, Jr. discloses a system for promoting healing of a wound at a tissue site (system 100 for treating wound site with negative pressure; Figure 1; Paragraph 0021), comprising:
a dressing (dressing 115; Paragraph 0028; Figure 1) 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 an external environment for receiving negative pressure (manifold 120 can be porous and placed at the tissue site 105 while covered by a sealing member 125 to maintain suction pressure in the therapeutic environment within the dressing, separate from the external environment; Paragraph 0028-0031; 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 is pump sensor 156 and wound pressure sensor 155 to measures the difference in pressure between wound site and pump and outputs a leakage signal, where the input of the sensor 156 is fluidly coupled to conduit 130 and input of wound pressure sensor 155 is fluidly coupled through conduit 160 and connector 150 between dressing 115 and vacuum source 110 and where the output is a differential pressure signal/flow rate signal delivered to the controller 170; Paragraph 0037-0038 and 0050; Figure 1);
a controller coupled to the output of the flow rate sensor (controller 170 has an input of the differential pressure measurement/flow rate from sensors 155/156 and an output to the source 110; Paragraphs 0023, 0037-0038, and 0050-0051) and configured to (i) determine a flow rate (FR) based on the flow-rate signal (flow rate is calculated from differential pressure signal of sensors 155/156; Paragraph 0050), (ii) compare the flow rate (FR) to a minimum flow rate (MinFR) (“Hence, it is desirable to keep the bang-bang controller running during treatment sessions as much as possible for low leakage conditions such as, for example, when the flow rate (FR) is less than or equal to a fixed target flow rate (TFR) which represents a low leak condition…” – Paragraph 0066; Figure 6), and (iii) generate a low-leak signal when the flow rate (FR) is less than the minimum flow rate (MinFR) (Paragraph 0066 – low leak condition is detected; Figure 6); and
a regulator coupled to the controller and adapted to increase the flow rate (FR) by increasing a leakage into the therapeutic environment in response to an occurrence of a low-leak signal (bang-bang controller and PID controller are components of the regulator is connected to controller 170 to increase the leakage in response to a low leak signal; Figure 6 – PP3 is the low leak signal and the leakage is then increased to reach PP_max; Paragraph 0064-0066).
Regarding claim 25, Francis, Jr. discloses the system of claim 24. Francis, Jr. further discloses wherein the flow rate sensor comprises a first pressure sensor for sensing a first pressure (second pressure sensor 156 measures pump pressure; Paragraph 0038; Figure 1) and a second pressure sensor for sensing a second pressure (first pressure sensor 155 measures wound pressure; Paragraph 0037; Figure 1), and wherein the controller is electrically coupled to the first pressure sensor and the second pressure sensor and is further configured to determine the flow rate (FR) based on the difference between the first pressure and the second pressure (controller can calculate the flow rate from difference in pressures from the first and second sensors 155/156 outputs; Paragraph 0050).
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) 3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Francis, Jr. et al. (Publication No. US 2019/0125942 A1) in view of Locke et al. (Publication No. WO 2019/036169 A1).
Regarding claim 3, Francis, Jr. discloses the system of claim 1. Francis, Jr. does not teach wherein the regulator is configured to increase the leakage by venting gases from the external environment to the therapeutic environment.
However, Locke teaches 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).
Francis, Jr. and Locke 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 Francis, Jr. to incorporate the teachings of Locke to have the regulator of Francis, Jr. to be fluidly coupled to the source of ambient air of Locke and deliver the ambient air as the leakage of Locke to the wound dressing of Francis, Jr.. This would allow for the device to compensate the head pressure within the wound dressing after negative pressure is applied (Locke; Paragraph 0058-0059).
Regarding claim 5, Francis, Jr. in view of Locke teaches the system of claim 1. The combination of Francis, Jr. in view of Locke further teaches wherein the leakage has a first leakage threshold and a second leakage threshold (Locke; “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, Francis, Jr. in view of Locke teaches the system of claim 3. The combination of Francis, Jr. in view of Locke further teaches wherein the regulator is configured further to increase the leakage from zero to a first leakage threshold (Locke; 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, Francis, Jr. in view of Locke teaches the system of claim 6. The combination of Francis, Jr. in view of Locke further teaches wherein the regulator is configured further to increase the leakage by venting gases at a fixed rate (Locke; Paragraph 0060 – predetermined increase in leakage to prevent formation of blockages; Claim 12).
Regarding claim 8, Francis, Jr. in view of Locke teaches the system of claim 6. The combination of Francis, Jr. in view of Locke further teaches wherein the regulator is configured further to increase the leakage by venting gases at a variable rate (Locke; Paragraph 0008 and 0048-0051; Claim 13).
Regarding claim 9, Francis, Jr. in view of Locke teaches the system of claim 8. The combination of Francis, Jr. in view of Locke further teaches wherein the regulator is configured further to vary an amplitude of the variable rate (Locke; 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, Francis, Jr. in view of Locke teaches the system of claim 8. The combination of Francis, Jr. in view of Locke further teaches wherein the regulator is configured further to vary a frequency of the variable rate (Locke; Paragraph 0062 – controller may be programmed to activate the valve more frequently for longer periods of time).
Regarding claim 11, Francis, Jr. in view of Locke teaches the system of claim 8. The combination of Francis, Jr. in view of Locke further teaches wherein the regulator is configured further to vary a duty cycle of the variable rate (Locke; 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).
Claim(s) 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Francis, Jr. et al. (Publication No. US 2019/0125942 A1) in view of Muser et al. (Publication No. US 2017/0165405 A1).
Regarding claim 21, Francis, Jr. discloses the system of claim 1. Francis further teaches wherein the pump is coupled to a motor for driving the pump in response to an 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). 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 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 motor (pump can indirectly measure flow rate from voltage of pump motor over time; Paragraph 0103).
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 Francis, Jr. to incorporate the teachings of Muser to have the controller of Francis, Jr. to calculate the flow rate based on the change in power applied to the pump, as taught by Muser. This would allow for the device to indirectly measure the flow rate in the device (Muser; Paragraph 0103).
Regarding claim 23, Francis, Jr. discloses the system of claim 1. Francis, Jr. further teaches wherein the pump is coupled to a motor for driving the pump in response to an 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). Francis, Jr. does not teach the controller is configured further to determine the flow rate (FR) based on a time rate of change of a current applied to the motor.
However, Muser teaches the controller is configured further to determine the flow rate (FR) based on a time rate of change of a current applied to the motor (pump can indirectly measure flow rate from voltage of pump motor over time; Paragraph 0103).
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 Francis, Jr. to incorporate the teachings of Muser to have the controller of Francis, Jr. to calculate the flow rate based on the change in current applied to the pump, as taught by Muser. This would allow for the device to indirectly measure the flow rate in the device (Muser; Paragraph 0103).
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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