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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/26 has been entered.
Response to Amendment
Applicant amended claims 1, 11, and 23. Claims 1-2, 4-9, 11-12, 14-16, 18, and 21-24 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 7-8 of Applicant’s Remarks, filed 02/02/26, with respect to the rejections of claims 1-2, 4-9, 11-12, 14-16, 18, and 21-24 under 35 U.S.C. 103 as being unpatentable over Long in view of Hunt, in further view of Kompanek, and in further view of Brandolini have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
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.
Claims 1-2, 4-9, 11-12, 14-16, 18, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (WO 2019/135900 A1) in view of Hunt (US 2018/0140466 A1), in further view of Kompanek (US 4,193,010 A), in further view of Johannison (US 2012/0046625 A1), and in further view of Brandolini et al. (WO 2020/011690 A1).
Regarding claims 1 and 11, Long discloses a negative pressure wound therapy (NPWT) system (Figs. 1-2, feat. 100; ¶0036), comprising: a therapy unit (102; ¶0037), with respect to claim 1, or a therapy unit (Figs. 1-2, feat. 102; ¶0037) for a negative pressure wound therapy (MPWT) system (Figs. 1-2, feat. 100; ¶0036), with respect to claim 11, comprising: a first pump configured to draw a negative pressure (Fig. 2, feat. 120; ¶0039) at a wound site (106) through a first tubular member (108); and a piezo-electric pump fluidly coupled with the first tubular member (¶0039-0041: the system may include a plurality of piezo-electric pumps 120 coupled to tubing 108); and a controller (Figs. 2-3, feat. 114; ¶0046-0058) comprising processing circuitry (146; ¶0051-0052): obtain feedback signals from the piezo-electric pump (Figs. 2-3, feats. 158 and 136; ¶0058, 0063, and 0077: the controller monitors the resonance frequency of piezo-electric pumps via resonance sensor 136 and resonance monitor 158).
Long does not disclose that the piezo-electric pump is coupled with the first tubular member through a bypass tubular member and configured to detect a fluid indication, that the bypass tubular member extends between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound site, or that the processing circuitry of the controller is configured to determine if fluid is present at the piezo electric pump based on the feedback signals and shut off operation of the first pump in response to determining that fluid is present at the piezo-electric pump.
Hunt teaches a pump array (Fig. 7B, feat. 1000; ¶0073) for negative pressure wound therapy systems (Figs. 10-11B; ¶0077-0081) comprising first (Fig. 7B, feat. 1010’) and second (1020’) pumps arranged in parallel between and inlet (1030) and an outlet (1040) via an inlet manifold (1050’) and an outlet manifold (1060’). Because the pumps are in parallel with each other, they are each connected with the inlet (1030) via a bypass line relative to the other pump. Hunt further teaches that the pumps may be piezo-electric pumps (Abstract; ¶0082). Hunt teaches that connecting pumps in parallel advantageously provides increased flow rate (¶0073). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Long so that the piezo-electric pump is coupled with the first tubular member through a bypass tubular member in order to provide increased flow rate as taught by Hunt.
Long in view of Hunt does not suggest that the piezo-electric pump is configured to detect a fluid indication, that the bypass tubular member extends between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound site, or that the processing circuitry of the controller is configured to determine if fluid is present at the piezo electric pump based on the feedback signals and shut off operation of the first pump in response to determining that fluid is present at the piezo-electric pump.
Kompanek teaches piezo-electric sensors (Figs. 1-3, feat. 10; Col. 3, lines 14-53) which vibrates at a resonant frequency which changes based on whether or not whether or not a material such as a fluid is in contact with the sensor (Col. 2, lines 3-47; Col. 3, 14-28; Col. 4, line 54 – Col. 5, line 9), thereby indicating the presence or absence of the material such as a fluid. Kompanek teaches that piezo-electric sensors are simple, compact, rugged, and inexpensive (Col. 2, lines 36-47). The piezo-electric pumps of Long (¶0040) and Hunt (¶0100) pump fluids such as air by oscillating or vibrating at particular frequencies, and are therefore configured for detecting fluids as taught by Kompanek. Long further discloses that the controller monitors the resonant frequency of the piezoelectric pump (¶0058, 0063, and 0077), and therefore the controller of the system of Long in view of Hunt is capable of determining whether or not fluid is present at the piezo-electric pump based on the teachings of Kompanek. Using the piezo-electric pump of the system of Long in view of Hunt as a piezo-electric sensor as taught by Kompanek would advantageously allow the system to detect the presence of fluid without requiring additional sensors. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Long in view of Hunt so that the piezo-electric pump is configured to detect a fluid indication and so that the controller is configured to determine if fluid is present at the piezo-electric pump based on the feedback signals in order to provide a simple, compact, rugged, and inexpensive way of detecting fluids as taught by Kompanek and detect fluids without requiring additional sensors.
Long in view of Hunt and in further view of Kompanek does not suggest that the bypass tubular member extends between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound site or that the controller is configured to shut off operation of the first pump in response to determining that fluid is present at the piezo-electric pump.
Johannison teaches a negative pressure wound therapy system (Fig. 1; ¶0038-0044) comprising a first pump (9) for applying negative pressure to a canister (6) and wound site (5) via a first conduit (8) and a second conduit (10; ¶0039 and 0041) and a second pump (12) in fluid communication with the first conduit and second conduit via bypass conduits extending between a first position at the first conduit (8), but downstream of the wound (5), and a second position at the second conduit (10), but upstream from the first pump (9). Johannison teaches that the second pump, which may be a piezoelectric pump (¶0044), may be used to circulate gas to clear blockages in the conduits (¶0043). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Long in view of Hunt and in further view of Kompanek so that the bypass tubular member extends between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound site in order to use the piezo-electric pump to clear blockages in the first tubular member as taught by Johannison.
Long in view of Hunt, in further view of Kompanek, and in further view of Johannison does not disclose that the controller is configured to shut off operation of the first pump in response to determining that fluid is present at the piezo-electric pump.
Brandolini teaches a negative pressure wound therapy system (Fig. 1, feat. 100; Page 6, line 22 - Page 7, line 13) comprising a pump assembly (Fig. 1, feat. 150; Fig. 2A, feat. 230; Page 10, lines 2-20) with an auxiliary system (Fig. 4, feat. 268) comprising a primary pump (330) and an auxiliary pump (410; Page 14, lines 15-25). The auxiliary system may further include one or more sensors (430) which may sense the presence of moisture in the primary pump, among other things (Page 15, lines 18-30). In response to the indication of moisture in the primary pump, a controller may determine that the primary pump is unable to provide therapy and disable it (Page 16, lines 1-13), as well as triggering an alarm to indicate that the primary pump has failed (Page 16, line 25 – Page 17, line 8). Brandolini teaches that shutting down the primary pump and providing an alarm indicating its failure helps to limit unscheduled interruptions to therapy due to pump failure or malfunction (Page 1, line 25 – Col. 4, line 2). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Long in view of Hunt, in further view of Kompanek, and in further view of Johannison so that the processing circuitry of the controller is further configured to shut off operation of the first pump in response to determining that fluid is present at the piezo-electric pump as taught by Brandolini in order to help limit unscheduled interruptions to therapy.
Regarding claims 2 and 12, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 1 and unit of claim 11. Hunt further teaches that a voltage (Fig. 5, feat. 36) across the piezo-electric sensor (Fig. 5, feat. 18) may be used to indicate how the piezo-electric sensor is oscillating, and therefore whether or not fluid is present (Col. 3, lines 29-53; Col. 4, line 54 – Col. 5, line 9). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggests that the feedback signals obtained from the piezo-electric pump comprise a voltage across the piezo-electric pump.
Regarding claims 4 and 14, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 1 and unit of claim 11. As discussed above, Brandolini further teaches that an alarm should be triggered in response to an indication of moisture (Page 16, line 25 – Page 17, line 8). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggest that the processing circuitry of the controller is configured to notify a caregiver in response to determining that fluid is present at the piezo-electric pump.
Regarding claims 5 and 15, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 1 and unit of claim 11. As discussed above, Long discloses that the processing circuitry of the controller monitors the resonant frequency of the piezo-electric pump (¶0058, 0063), and further discloses that the controller can determine if the resonant frequency is different than a target resonant frequency (¶0077). As discussed above, Kompanek teaches that a change in the resonant frequency of a vibrating piezo-electric device may indicate the presence or absence of a fluid (Col. 3, lines 14-28). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggests that the processing circuitry of the controller is configured to: determine an oscillation frequency of the piezo-electric pump based on the feedback signals of the piezo-electric pump and determine if fluid is present at the piezo-electric pump based on the oscillation frequency.
Regarding claims 6 and 16, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 5 and unit of claim 15. As discussed above, Long discloses that the processing circuitry of the controller monitors the resonant frequency of the piezo-electric pump (¶0058, 0063), and further discloses that the controller can determine if the resonant frequency is different than a target resonant frequency (¶0077). Therefore, Long discloses that the processing circuitry of the controller is configured to compare the oscillation frequency of the piezo-electric pump to a predetermined value. Kompanek teaches that a change in the resonant frequency of a vibrating piezo-electric device may indicate the presence or absence of a fluid (Col. 3, lines 14-28) and further teaches that the piezo-electric device may be configured to increase its oscillation frequency when exposed to fluids (Col. 4, lines 54-66). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggests that the processing circuitry of the controller is configured to compare the oscillation frequency of the piezo-electric pump to a predetermined oscillation frequency value and determine that fluid is present at the piezo-electric pump in response to the oscillation frequency exceeding the predetermined oscillation frequency value.
Regarding claim 7, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 5. Long further discloses that the resonance frequency of the piezo-electric pump may be monitored to determine if the pump is converting electricity into heat instead of properly mechanically oscillating and pumping air (¶0077). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggests that the processing circuitry of the controller is configured to determine if the piezo-electric pump is inoperational based on the oscillation frequency.
Regarding claims 8 and 18, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 1 and the unit of claim 15, and Long further discloses that the therapy unit (Figs. 1-2, feat. 102; ¶0036-0037) further comprises a pressure sensor (126; ¶0048) fluidly coupled with the wound site (106) and configured to read a pressure from the wound site (¶0048), wherein the processing circuitry (Fig. 3, feat. 146; ¶0051) of the controller (114) is configured to operate the first pump do draw the negative pressure at the wound site based on the pressure at the wound site (¶0056 and 0062).
Regarding claim 9, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the system of claim 8, and Long further discloses that the controller is configured to operate the first pump and the piezo-electric pump simultaneously (¶0066: the controller can control a plurality of pumps simultaneously).
Regarding claim 21, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the unit of claim 11. Long further discloses that the therapy device (Figs. 1-2, feat. 102) may include multiple pumps (120) within it (¶0040-0041), and therefore discloses multiple pumps within a housing. Hunt further teaches that both piezo-electric pumps (Figs. 17A-17B, feat. 1700; ¶0099-0102) and diaphragm pumps (Figs. 19A-B; ¶0106-0109) may be included in a pumping array (Figs. 7A-8; ¶0071-0075) used in negative pressure wound therapy systems (Figs. 11A-B; ¶0110-0111). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggests a housing, wherein the first pump is a diaphragm pump and the diaphragm pump and the piezo-electric pump are positioned within the housing.
Regarding claim 22, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini suggests the unit of claim 11, and Long further discloses a canister configured to collect fluid drawn from the wound due to operation of the first pump (Figs. 1-2, feat. 104; ¶0038).
Regarding claim 23, Long discloses a method for limiting operation of a negative pressure wound therapy (NPWT) unit (Figs. 1-2, feat. 100; ¶0016-0021, 0036), the method comprising: operating a first pump to draw a negative pressure (Fig. 2, feat. 120; ¶0039 and 0073) at an inner volume of a wound dressing (106) through a first tubular member (108); obtaining and monitoring feedback signals from a piezo-electric pump (¶0039-0041: the system may include a plurality of piezo-electric pumps 120 coupled to tubing 108; Figs. 2-3, feats. 158 and 136; ¶0058, 0063, and 0077: the controller monitors the resonance frequency of piezo-electric pumps via resonance sensor 136 and resonance monitor 158); and determining an actual oscillation frequency of the piezo-electric pump using the feedback signals (¶0058, 0063, and 0077: the controller monitors the resonance frequency of piezo-electric pumps via resonance sensor 136 and resonance monitor 158).
Long does not disclose that the piezo-electric pump is fluidly coupled in parallel with the first pump, that the piezo-electric pump is fluidly coupled with the first pump via a bypass tubular member, the bypass tubular member extending between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound dressing, or steps of determining if the actual oscillation frequency indicates fluid contamination at the piezo-electric pump or shutting off operation of the first pump in response to the actual oscillation frequency indicating fluid contamination at the piezo-electric pump.
Hunt teaches a pump array (Fig. 7B, feat. 1000; ¶0073) for negative pressure wound therapy systems (Figs. 10-11B; ¶0077-0081) comprising first (Fig. 7B, feat. 1010’) and second (1020’) pumps arranged in parallel between and inlet (1030) and an outlet (1040) via an inlet manifold (1050’) and an outlet manifold (1060’). Because the pumps are in parallel with each other, they are each connected with the inlet (1030) via a bypass line relative to the other pump. Hunt further teaches that the pumps may be piezo-electric pumps (Abstract; ¶0082). Hunt teaches that connecting pumps in parallel advantageously provides increased flow rate (¶0073). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Long so that the piezo-electric pump is fluidly coupled in parallel with the first pump in order to provide increased flow rate as taught by Hunt.
Long in view of Hunt does not suggest that the piezo-electric pump is fluidly coupled with the first pump via a bypass tubular member, the bypass tubular member extending between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound dressing, or steps of determining if the actual oscillation frequency indicates fluid contamination at the piezo-electric pump or the steps of determining if the actual oscillation frequency indicates fluid contamination at the piezo-electric pump or shutting off operation of the first pump in response to the actual oscillation frequency indicating fluid contamination at the piezo-electric pump.
Kompanek teaches piezo-electric sensors (Figs. 1-3, feat. 10; Col. 3, lines 14-53) which vibrates at a resonant frequency which changes based on whether or not whether or not a material such as a fluid is in contact with the sensor (Col. 2, lines 3-47; Col. 3, 14-28; Col. 4, line 54 – Col. 5, line 9), thereby indicating the presence or absence of the material such as a fluid. Kompanek teaches that piezo-electric sensors are simple, compact, rugged, and inexpensive (Col. 2, lines 36-47). The piezo-electric pumps of Long (¶0040) and Hunt (¶0100) pump fluids such as air by oscillating or vibrating at particular frequencies, and are therefore configured for detecting fluids as taught by Kompanek. Long further discloses that the controller monitors the resonant frequency of the piezoelectric pump (¶0058, 0063, and 0077), and therefore the controller of the system of Long in view of Hunt is capable of determining whether or not fluid is present at the piezo-electric pump based on the teachings of Kompanek. Using the piezo-electric pump of the system of Long in view of Hunt as a piezo-electric sensor as taught by Kompanek would advantageously allow the system to detect the presence of fluid without requiring additional sensors. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Long in view of Hunt so that the method includes determining if the actual oscillation frequency indicates fluid contamination at the piezo-electric pump in order to detect fluids without requiring additional sensors.
Long in view of Hunt and in further view of Kompanek does not suggest that the piezo-electric pump is fluidly coupled with the first pump via a bypass tubular member, the bypass tubular member extending between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound dressing, or steps of determining if the actual oscillation frequency indicates fluid contamination at the piezo-electric pump or shutting off operation of the first pump in response to the actual oscillation frequency indicating fluid contamination at the piezo-electric pump.
Johannison teaches a negative pressure wound therapy system (Fig. 1; ¶0038-0044) comprising a first pump (9) for applying negative pressure to a canister (6) and wound site (5) via a first conduit (8) and a second conduit (10; ¶0039 and 0041) and a second pump (12) in fluid communication with the first conduit and second conduit via bypass conduits extending between a first position at the first conduit (8), but downstream of the wound (5), and a second position at the second conduit (10), but upstream from the first pump (9). Johannison teaches that the second pump, which may be a piezoelectric pump (¶0044), may be used to circulate gas to clear blockages in the conduits (¶0043). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Long in view of Hunt and in further view of Kompanek so that the piezo-electric pump is fluidly coupled with the first pump via a bypass tubular member, the bypass tubular member extending between a first position on the first tubular member and a second position on the first tubular member, both the first position and the second position being between the first pump and the wound dressing in order to use the piezo-electric pump to clear blockages in the first tubular member as taught by Johannison.
Long in view of Hunt, in further view of Kompanek, and in further view of Johannison does not disclose shutting off operation of the first pump in response to the actual oscillation frequency indicating fluid contamination at the piezo-electric pump.
Brandolini teaches a negative pressure wound therapy system (Fig. 1, feat. 100; Page 6, line 22 - Page 7, line 13) comprising a pump assembly (Fig. 1, feat. 150; Fig. 2A, feat. 230; Page 10, lines 2-20) with an auxiliary system (Fig. 4, feat. 268) comprising a primary pump (330) and an auxiliary pump (410; Page 14, lines 15-25). The auxiliary system may further include one or more sensors (430) which may sense the presence of moisture in the primary pump, among other things (Page 15, lines 18-30). In response to the indication of moisture in the primary pump, a controller may determine that the primary pump is unable to provide therapy and disable it (Page 16, lines 1-13), as well as triggering an alarm to indicate that the primary pump has failed (Page 16, line 25 – Page 17, line 8). Brandolini teaches that shutting down the primary pump and providing an alarm indicating its failure helps to limit unscheduled interruptions to therapy due to pump failure or malfunction (Page 1, line 25 – Page 4, line 2). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Long in view of Hunt and in further view of Kompanek so that it includes shutting off operation of the first pump in response to the actual oscillation frequency indicating fluid contamination at the piezo-electric pump as taught by Brandolini in order to help limit unscheduled interruptions to therapy.
Regarding claim 24, Long in view of Hunt in further view of Kompanek, in further view of Johannison and in further view of Brandolini suggests the method of claim 23. As discussed above, Brandolini teaches that providing an alarm helps to limit unscheduled interruptions to therapy due to pump failure or malfunction (Page 1, line 25 – Page 4, line 2). Therefore, Long in view of Hunt, in further view of Kompanek, in further view of Johannison, and in further view of Brandolini further suggests providing an alert to a caregiver or a patient in response to the actual oscillation frequency indicating fluid contamination at the piezo-electric pump.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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