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 .
Status of the Claims
Claims filed 06/10/2025 has been entered. Claims 1, 4-7, 9, 11-13, 15-20 and 22-27 are pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/10/2025 was filed after the mailing date of the non-final office action on 03/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
In response to the applicant’s argument, see pages 7-9, with respect to 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation of DeBusk et al (US 20150133829 A1) in view of Klusmann et al (US 20170209630 A1).
In response to the applicant’s argument, see pages 9-10, that the prior art fails to teach “wherein the second controller does not communicate with the first controller” as recited in amended claim 1 because, although Klusmann teaches stand-alone impact sensor module controller function independent of the microelectronic controller of the control unit, Klusmann further teaches that the stand-alone impact sensor module and microcontroller communicate with each other.
This is not found persuasive for the following reasons below. Although Klusmann teaches that [0111] “an impact sensor 29, which is capable of communicating with electronic control unit 18” and [0112] “It is possible, that the impact sensor 29 communicates directly, by means of an interface, with the electronic control unit 18.” (emphasize added), The rejection does not rely upon the entirety of Klusman’s teaching being bodily incorporated into the primary reference. Rather, Klusmann is relied upon for its express teaching that the standalone impact sensor module functions independently of the microelectronic controller of the control unit ([0121]) One of skill in the art who is seeking to prevent malfunction of the device after storage and/or transportation while conserving energy and extend battery life would have been motivated to apply Klusmann’s teaching of independent operation to the primary reference as Klusmann expressly teaches that independent operation permits monitoring whether the device has been exposed to an extreme conditions during storage and/or transportation that could potentially cause malfunction, without requiring unnecessary operation of the device, thereby conserving energy ([0036, 0058-0065 and 0121]).
Furthermore, Klusmann teaches that the standalone impact sensor module is capable of operating while the remainder of the device, including the electronic control unit, is turned off ([0121]). therefore, at least under such a condition, the second processor is capable of monitoring the device without communicating the first processor.
Note: A different Klusmann publication is relied upon in the present office action because it provides a clearer disclosure of the relevant teaching.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 line 3 recites “data recorded” which should read “data recording”.
Appropriate correction is required.
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, 4, 7, 9, 11-13, 16-20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over DeBusk et al (US 20150133829 A1) in view of Klusmann et al (US 20170209630 A1)
Regarding claim 1, Debusk substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An apparatus (figure 1, NPWT unit 12) for applying pressure to a wound, the apparatus comprising:
a first housing (figure 1, housing of NPWT system 10 illustrated in figures 9a-b, housing 54);
a pressure source (figure 1 and [0046] vacuum pump 22 disposed within the NPWT unit housing 54) supported by the first housing, the pressure source being configured to couple via a fluid flow path (figure 1, air line 24) to a wound dressing (figure 1 and [0040] wound dressing 20 positioned over a wound 21) positioned on a wound and provide negative pressure to the wound;
a first controller (figure 1 and [0041], controller 28 controls the pump 22) configured to operate the pressure source; and
a data recorder (figure 1, mobile communication device 36) comprising:
a second housing (figure 1, housing of mobile communication device 36 further illustrated in figures 9a-b housing 56 can be disposed within a recess 58 of housing 54) supported by the first housing;
a sensor within the second housing and configured to generate sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller; and
a second controller (figure 1, microprocessor 38) within the second housing and configured to:
in a first mode of operation:
store the sensor data to a memory device, and
detect the error condition from the sensor data, and
transition into a second mode of operation responsive to detection of the error condition from the sensor data, wherein during the second mode of operation an amount or frequency for collecting the sensor data is increased in comparison to the first mode of operation in order to increase a likelihood of capturing sufficient amount of sensor data for troubleshooting the error condition,
wherein the second controller does not communicate with the first controller.
Debusk does not teach the data recorder comprising:
a sensor within the second housing and configured to generate sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller; and
the second controller configured to:
in a first mode of operation:
store the sensor data to a memory device, and
detect the error condition from the sensor data, and
transition into a second mode of operation responsive to detection of the error condition from the sensor data, wherein during the second mode of operation an amount or frequency for collecting the sensor data is increased in comparison to the first mode of operation in order to increase a likelihood of capturing sufficient amount of sensor data for troubleshooting the error condition,
wherein the second controller does not communicate with the first controller.
In the same field of endeavor, namely a portable negative pressure device, Klusmann teaches a NPWT device (figure 3, device 1) comprising a first controller and a data recorder (figure 3, electronic control unit 18 and a stand-alone impact sensor module 29 illustrated in figure 5)
The data recorder comprising:
a sensor ([0068] stand-alone impact sensor module comprises at least one impact sensor) within the second housing and configured to generate sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller ([0016-0027] the impact sensor is configured to detect an impact acting on the device, the impact lead to malfunction of the device including malfunction electric/electronic component and malfunction of mechanical components associated with electronic control unit 18); and
the second controller ([0068] microelectronic controller) configured to:
in a first mode of operation ([0058-0065] sleep mode):
store the sensor data to a memory device ([0055 0058-0065] storing impact sensor related data to memory), and
detect the error condition from the sensor data ([0025-0028 and 0058-0065] detecting impact above predetermined threshold correlating to malfunction), and
transition into a second mode of operation ([0026, 0058-0065] upon detecting the impact, the device is switched to a wake phase) responsive to detection of the error condition from the sensor data, wherein during the second mode of operation an amount or frequency for collecting the sensor data is increased in comparison to the first mode of operation ([0058-0065] collecting the impact data in higher sampling rate for reliable detection of impact) in order to increase a likelihood of capturing sufficient amount of sensor data for troubleshooting the error condition,
wherein the second controller does not communicate with the first controller ([0121] at least the stand-alone impact sensor functions independent of the microelectronic controller of the control unit without requiring communicating with the electronic control unit 18)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk to incorporate the teachings of Klusmann and provide the data recorder as claimed for the purpose of monitoring whether the device is exposed to extreme environmental conditions during storage and/or transportation that could potentially cause malfunction of the device, while avoiding unnecessary operation of the device and conserving energy
as taught by Klusmann ([0036, 0058-0065 and 0121]).
Regarding claim 4, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches the second controller is configured to add an entry to a log indicating an occurrence of the error condition ([0027, 0055, 0056, 0066, 0112 and 0122] the impact data related to malfunction is stored in a memory indicating an occurrence of the impact).
Regarding claim 7, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the memory device is non-wipeable or non-resettable (Klusmann; [0118] memory including ROM is a non-volatile computer memory that permanently stores the data).
Alternatively, in the event that this interpretation is not envisaged by applicant, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to have the non-wipeable or non-resettable memory device, as Klusmann does not expressly teach the memory is being resettable and/or wipeable, and Klusmann teaches the memory is configured to store impact sensor related data for future access ([0055]). Thus, one of skill in the art would have found it obvious to configure the memory as non-wipeable to prevent the stored impact-sensor-related data from being inadvertently erased and thereby maintain the data for review.
Regarding claim 9, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the sensor comprises a temperature sensor, and the sensor data comprises temperature data (Klusmann; [0016] the impact sensor comprises temperature sensors).
Regarding claim 11, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the second controller is configured to:
determine a cause of the error condition from the sensor data (Klusmann; [0026-0028]) determine impact correlating to malfunction); and
output an indication of the cause for presentation on a display ([0048 and 0122] controller to display an alarm message correlating impact acting on the device).
Regarding claim 12, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the second controller is configured to determine and output a user instruction indicating how to remedy the error condition (Klusmann; [0026-0028] instruct technician to inspect or exchange components ).
Regarding claim 13, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the data recorder comprises a display supported by the second housing, the display comprising electronic ink or one or more light sources (Debusk; [0042] mobile communication device 36 such as smart phone including a touch screen display include at least one or more light sources).
Regarding claim 16, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the error condition prevents performance of the pressure therapy with the first controller (Klusmann; [0027 and 0066] the malfunction lock the device which prevent a patient from using the device).
Regarding claim 17, Debusk teaches a method comprising:
generating, with a sensor positioned in a recorder housing of a data recorder (figures 1 9a-b, mobile communication device 36 and housing 56 of the device) , sensor data usable to troubleshoot an error condition associated with operation of a wound therapy device, the recorder housing being positioned in a device housing of the wound therapy device (figures 1 9a-b, mobile communication device 36 housed within a recess 58 of housing 54);
at a first time:
in a first mode of operation, storing, with a controller of the data recorder, the sensor data to a memory device positioned in the recorder housing;
in the first mode of operation, detecting, with the controller, the error condition from the sensor data ;and
at a second time:
transitioning the data recorder into a second mode of operation in response to detecting the error condition from the sensor data, and, in the second mode of operation, increasing with the controller an amount or frequency of the sensor data collected in comparison to the first mode of operation in order to increase a likelihood of capturing sufficient amount of sensor data for troubleshooting the error condition;
wherein the controller does not communicate with any components of the wound therapy device apart from components of the data recorder.
Debusk does not teach the method comprising:
generating, with a sensor, sensor data usable to troubleshoot an error condition associated with operation of a wound therapy device;
at a first time:
in a first mode of operation, storing, with a controller of the data recorder, the sensor data to a memory device positioned in the recorder housing;
in the first mode of operation, detecting, with the controller, the error condition from the sensor data ;and
at a second time:
transitioning the data recorder into a second mode of operation in response to detecting the error condition from the sensor data, and, in the second mode of operation, increasing with the controller an amount or frequency of the sensor data collected in comparison to the first mode of operation in order to increase a likelihood of capturing sufficient amount of sensor data for troubleshooting the error condition;
wherein the controller does not communicate with any components of the wound therapy device apart from components of the data recorder.
In the same field of endeavor, namely a portable negative pressure device, Klusmann teaches a method comprising generating, with a sensor, sensor data usable to troubleshoot an error condition associated with operation of a wound therapy device (figure 3 and [0016-0027 and 0068] stand-alone impact sensor module comprises at least one impact sensor is configured to detect an impact acting on the device usable to troubleshoot malfunction of the device)
at a first time ([0058-0065] during sleep mode):
in a first mode of operation, storing, with a controller of the data recorder, the sensor data to a memory device positioned in the recorder housing ([0055 0058-0065] storing impact sensor related data to memory);
in the first mode of operation, detecting, with the controller, the error condition from the sensor data ([0026, 0055, 0058-0065] detecting impact above a predetermined threshold level correlating malfunction);and
at a second time ([0058-0065] wake phase):
transitioning the data recorder into a second mode of operation in response to detecting the error condition from the sensor data ([0058-0065]upon detecting the impact above predetermined threshold, the device is switched to the wake phase), and, in the second mode of operation, increasing with the controller an amount or frequency of the sensor data collected in comparison to the first mode of operation in order to increase a likelihood of capturing sufficient amount of sensor data for troubleshooting the error condition ([0058-0065] collecting the impact date in higher sampling rate for reliable detection of impact));
wherein the controller does not communicate with any components of the wound therapy device apart from components of the data recorder ([0121] at least the stand-alone impact sensor functions independent of the microelectronic controller of the control unit without requiring communicating with any other component of the device).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk to incorporate the teachings of Klusmann and provide the method as claimed for the purpose of monitoring whether the device is exposed to extreme environmental conditions during storage and/or transportation that could potentially cause malfunction of the device, while avoiding unnecessary operation of the device and conserving energy during monitoring as taught by Klusmann ([0036, 0058-0065 and 0121]).
Regarding claim 18, Debusk, as modified by Klusmann, teaches the method of claim 17.
The combination further teaches wherein the recorder housing is removable from the device housing. (Debusk; figures 9a-b, the mobile device 36 is removable from the housing 54).
Regarding claim 19, Debusk, as modified by Klusmann, teaches the method of claim 17.
The combination further teaches wherein the sensor comprises a motion sensor, and the sensor data comprises motion data (Klusmann; [0016] impact sensor comprises linear acceleration sensors)
Regarding claim 20, Debusk, as modified by Klusmann, teaches the method of claim 17.
The combination further teaches wherein the sensor comprises a temperature sensor, and the sensor data comprises temperature data (Klusmann; [0016] the impact sensor comprises temperature sensors).
Regarding claim 23, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination further teaches wherein the sensor is a motion sensor, and the sensor data comprises motion data (Klusmann; [0016] impact sensor comprises linear acceleration sensors).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over DeBusk et al (US 20150133829 A1) in view of Klusmann et al (US 20170209630 A1), and in further view of O’Donnell et al (US 20190128939 A1)
Regarding claim 5, Debusk, as modified by Klusmann, teaches the apparatus of claim 4.
The combination teaches wherein the second controller is configured to determine a frequency of occurrence of the error condition from the log.
O’Donnell teaches an integrated circuit system (figure 1a and [0063-0083] electronic circuit) determines and recording electronic overstress event, which is relatively pertinent to the problem posed by applicant of collecting sensor data usable for troubleshooting an error condition, is configured to determine a frequency of occurrence of the error condition from the log ([0063, 0067 and 0083] storing information indicative of number of occurrence of electrical overstress events).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of O’Donnell and provide the second controller as claimed for the purpose of determining lifespan of device and predicting schedule for replacement thereby preventing failure of the device in healthcare applications as taught by O’Donnell ([0064 0067-0068]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over DeBusk et al (US 20150133829 A1) in view of Klusmann et al (US 20170209630 A1) and Hartwell et al (US 20100185164 A1)
Regarding claim 6, Debusk teaches an apparatus for applying pressure to a wound, the apparatus comprising:
a first housing (figure 1, housing of NPWT system 10 illustrated in figures 9a-b, housing 54);
a pressure source (figure 1 and [0046] vacuum pump 22 disposed within the NPWT unit housing 54) supported by the first housing, the pressure source being configured to couple via a fluid flow path (figure 1, air line 24) to a wound dressing (figure 1 and [0040] wound dressing 20 positioned over a wound 21) positioned on a wound and provide negative pressure to the wound;
a first controller (figure 1 and [0041], controller 28 controls the pump 22) configured to operate the pressure source; and
a data recorder (figure 1, mobile communication device 36) comprising:
a second housing (figure 1, housing of mobile communication device 36 illustrated in figures 9a-b housing 56 can be disposed within a recess 58 of housing 54) supported by the first housing, the second housing being fireproof or shockproof;
a sensor within the second housing and configured to generate sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller; and
a second controller (figure 1, microprocessor 38) enclosed within the second housing and configured to:
store the sensor data to a memory device, and
output the sensor data from the memory device to an electronic device separate from the apparatus,
wherein the second controller does not communicate with the first controller.
Debusk does not teach the data recorder comprising:
a sensor within the second housing and configured to generate sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller; and
the second controller configured to:
store the sensor data to a memory device, and
output the sensor data from the memory device to an electronic device separate from the apparatus,
wherein the second controller does not communicate with the first controller.
In the same field of endeavor, namely a portable negative pressure device, Klusmann teaches a NPWT dvice (figure 3, device 1) comprising a first controller and a data recorder (figure 3, electronic control unit 18 and a stand-alone impact sensor module 29 further illustrated in figure 5);
The data recorder comprising a sensor ([0068 stand-alone impact sensor module comprises at least one impact sensor] within the second housing and configured to generate sensor data usable to troubleshoot an error condition ([0016-0027] the impact sensor is configured to detect an impact acting on the device, the impact potentially lead to malfunction of the device including malfunction electric/electronic component and malfunction of mechanical components associated with electronic control unit 18) associated with performance of pressure therapy with the first controller; and
the second controller ([0068] figure 5, microelectronic controller) configured to:
store the sensor data to a memory device ([0055, 0058-0064] storing impact sensor related data to a memory), and
output the sensor data from the memory device to an electronic device separate from the apparatus ([0055, 0058-0064 and 0134] output the impact data to remover server separate from the device 1),
wherein the second controller does not communicate with the first controller ([0121] at least the stand-alone impact sensor functions independent of the microelectronic controller of the control unit without requiring communicating with the electronic control unit 18).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk to incorporate the teachings of Klusmann and provides the data recorder as claimed for the purpose of monitoring whether the device is exposed to extreme environmental conditions during storage and/or transportation that could potentially cause malfunction of the device, while avoiding unnecessary operation of the device and conserving energy during the monitoring as taught by Klusmann ([0036, 0058-0065 and 0121]).
The combination does not teach the second housing being fireproof or shockproof.
In the same field of endeavor, namely a modular wound treatment apparatus, Hartwell teaches the second housing being fireproof or shockproof ([0034-0035, the device unit and waste canister is configured to separate when the apparatus is dropped to absorb shock].
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of Hartwell and provide the second housing as claimed for the purpose of preventing significant damage such that would impair its operation as taught by Hartwell ([0034])
Claims 15 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over DeBusk et al (US 20150133829 A1) in view of Klusmann et al (US 20170209630 A1), and in further view of Hartwell et al (WO 2017139686 A1).
Regarding claim 15, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination does not teach wherein the error condition comprises a blockage in the fluid flow path; though Klusmann teaches utilizing motion sensors to detect an impact acting on the device which causes malfunction of the device ([0016])
In the same field of endeavor, namely a system and methods for detecting operational conditions of reduced pressure therapy, Hartwell teaches wherein the error condition comprises a blockage in the fluid flow path ([0177 and 0185] signal from an activity monitor, for example, motion sensor, can indicate presence of blockage in the fluid flow path).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of Hartwell and provides the device as claimed for the purpose of indicating failure condition of the negative pressure system as taught by Hartwell ([0050]).
Regarding claim 24, Debusk, as modified by Klusmann, teaches the apparatus of claim 1.
The combination does not teach wherein the error condition comprises a low pressure level at the wound; though Klusmann teaches utilizing motion sensor to detect an impact acting on the device which causes malfunction of the device ([0016])
In the same field of endeavor, namely a system and methods for detecting operational conditions of reduced pressure therapy, Hartwell teaches wherein the error condition comprises a low pressure level at the wound ([0177 and 0185] signal from an activity monitor determine low pressure level at the wound, for example detecting increase level of activity of pump indicates a blockage of fluid path which result the wound dressing failing achieving the expected pressure)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of Hartwell and provides the device as claimed for the purpose of indicating failure condition of the negative pressure system as taught by Hartwell ([0050]).
Claims 22, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over DeBusk et al (US 20150133829 A1) in view of Klusmann et al (US 20170209630 A1), and in further view of Alvord et al (US 20100214057 A1).
Regarding claim 22, Debusk, as modified by Klusmann teaches the apparatus of claim 1.
The combination does not teach the second housing is tamper-proof.
Alvord teaches a biometric device, which relatively pertinent to the problem posed by applicant of preventing tampering and unauthorized access of the device, comprises a tamper-proof housing ([0022] housing 110 in size of cell phone, include tamper resistant feature).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of Alvord and provide the second housing as claimed for the purpose of preventing unauthorized access to patient data as taught by Alvord ([0022])
Regarding claim 25, Debusk, as modified by Klusmann teaches the apparatus of claim 1.
The combination does not teach wherein the second housing is configured to indicate tampering with the second housing.
Alvord teaches a biometric device, which relatively pertinent to the problem posed by applicant of preventing tampering and unauthorized access of the device, is configured to indicate tampering with the second housing ([0020] preventing tampering to prevent unauthorized access of the device).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of Alvord and provide the second housing as claimed for the purpose of preventing unauthorized access to patient data as taught by Alvord ([0022])
Regarding claim 26, Debusk, as modified by Klusmann teaches the apparatus of claim 1.
The combination does not teach wherein the data recorder is configured to wipe the memory device responsive to tampering with the second housing.
Alvord teaches a biometric device, which relatively pertinent to the problem posed by applicant of preventing tampering and unauthorized access of the device, is configured wipe the memory device responsive to tampering with the second housing ([0022] Another feature may simple erase any stored data and programs should the housing 110 be tampered with)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Debusk, as modified by Klusmann, to incorporate the teachings of Alvord and provide the second housing as claimed for the purpose of preventing unauthorized access to patient data as taught by Alvord ([0022])
Allowable Subject Matter
Claim 27 is 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: The prior art, alone or in combination, fails to teach (claim 6 and 27) a data recorder comprising: a second housing supported by the first housing, the second housing being fireproof or shockproof; a sensor within the second housing and configured to generate sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller; and a second controller enclosed within the second housing and configured to: store the sensor data to a memory device, and output the sensor data from the memory device to an electronic device separate from the apparatus, wherein the second controller does not communicate with the first controller; wherein the second controller is configured transition the data recorder from a first mode of operation to a second mode of operation responsive to detection of the error condition from the sensor data, wherein the data recorded is turned on in the first mode of operation, and wherein the data recorded is turned off in the second mode of operation to protect the data recorder from damage.
The closest prior art DeBusk et al (US 20150133829 A1) and Klusmann et al (US 20170209630 A1) teaches the device as claimed except for wherein the second controller is configured transition the data recorder from a first mode of operation to a second mode of operation responsive to detection of the error condition from the sensor data, wherein the data recorded is turned on in the first mode of operation, and wherein the data recorded is turned off in the second mode of operation to protect the data recorder from damage. Phil (US 5479341 A) teaches an electronic data security apparatus that is configured to detect external condition such as fire, water and theft, and upon detection, the security apparatus automatically stops operating the storage devices to protect the data storage devices from memory loss. However, the claim 6 requires the sensor data usable to troubleshoot an error condition associated with performance of pressure therapy with the first controller, and Klusmann teaches the second controller, which functions independent of the first processor, is configured to detect and record with a higher sampling rate responsive to detection of the error condition from the sensor data ([0058-0059]) to provide reliable detection of the error condition, rather than being turned off, and therefore the combination of the prior art fail to teach a motivation to modify the cited prior art to yield the limitation about without significantly altering Debusk and Klusmann.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/Examiner, Art Unit 3781
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