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
This Office Action is in response to the Amendment filed 06/18/2025. As directed by the amendment, Claims 1, 4, and 6-9 are amended, Claims 10-12, 19, 20, and 21 are canceled, and Claims 22 and 23 are added. Claims 1-9, 13-18, 22, and 23 are pending in the application.
Regarding the Office Action filed 11/13/2024:
The objections to the claims have been withdrawn due to Applicant’s amendments.
The rejections under 35 U.S.C. § 112 have been withdrawn due to Applicant’s amendments.
Applicant's arguments filed 04/15/2025 have been fully considered but they are not persuasive. Applicant’s arguments regarding amended claim 1 are not persuasive as Wilford teaches a thermal therapy modality and compression modality being applied in conjunction with each other; Col. 3; Lines 38-43, and a configuration where one of the controllers of section 100 or section 200 controls the operation of both modalities. As such the controller performs the action of coordinating timing between the two modalities and applying one of the modalities based on the operation of the other modality in order to allow both treatments to be delivered in conjunction, i.e. at the same time. Further, in a configuration where the thermal therapy modality and the compression modality are not delivered at the same time, the controller would have to stop one modality and initiate the other modality, as such the operation of the modalities are reliant on one another. Applicant’s argument regarding new claims 22 and 23 are not persuasive. A new rejection is made with regards to Wilford and Klopfenstein. Wilford teaches the control of treatment modalities and Klopfenstein teaches threshold values for a treatment plan that cannot be exceeded.
Priority
Acknowledgement is made to Applicant’s claim to priority to Provisional App. No. 63/091,284 filed October 13, 2020.
Information Disclosure Statement
The information disclosure statement filed January 13, 2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claims 1, 2, 6-9, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Klopfenstein et al. (U.S. Pub. No. 2021/0280309 A1 with respect to Foreign Priority date July 5th, 2018), Parish et al. (U.S. Pat. No. 8,778,005 B2) and Wilford et al. (U.S. Pat. No. 8,979,915 B2).
Regarding claim 1, Klopfenstein teaches a medical treatment device smart controller (4, ¶0074; Line 1) comprising:
connecting to a medical treatment device (‘medical device’, 2, Figs. 2-3, ¶0074; Lines 1-6, ¶0027 lines 1-2)
at least one wireless communication channel (¶0075, Lines 2-6) that is to receive a change input (‘control operation’, ¶0079; Lines 2-4),
a processor (‘processing unit’, 15, ¶0077; Lines 2-3) coupled to the wireless communication channel (Examiner notes: Klopfenstein discusses a ‘computer program’ executed by the processing unit [¶0077, lines 2-3] “to retrieve parameters contained in journals stored as files in the memory” [¶0100; Lines 1-4] and further, “at least a short range wireless communications capability for exchange of journal entries between the medical device controller and… …consumer electronic device” [para 0075 lines 3-6]) and configured to process the change input (¶0100; Lines 1-4),
memory (14, ¶0074; Lines 13-14) coupled to the processor (Examiner notes: the processor executes the computer program stored in the memory, [¶0077, lines 2-3, ¶0100; Lines 1-4] as discussed above), where the processor is configured to write recovery data into the memory (‘journals’, 16, ¶0074; Lines 14-15), the processor is further configured to periodically send the recovery data over the at least one wireless communication channel (¶0087; Lines 2-4 & 7-9).
Klopfenstein does not explicitly teach, a physical electrical connector, a treatment modality that can be changed when a signal is provided to the physical electrical connector, the change input altering the treatment modality, the processor being connected to the physical electrical connector, and sending the signal on the physical electrical connection to change the treatment modality of the medical treatment device, and the recovery data includes the change to the treatment modality of the medical treatment device, where the processor is further configured to:
determine when a deep vein thrombosis prophylaxis treatment modality and a compression treatment modality are both active;
coordinate timing between the deep vein thrombosis prophylaxis treatment modality and the compression treatment modality; and
control operation of the compression treatment modality based on the operation state of the deep vein thrombosis prophylaxis treatment modality.
However, Parish teaches a physical electrical connector (10, Fig. 12, Col. 10; Line 28-30), a signal being provided to the physical electrical connector (10, Col. 10; Lines 28-30), the processor being connected to the physical electrical connector (‘control unit’, Col. 10; Lines 25-30).
Further, Wilford teaches a treatment modality (Col. 1; Lines 31-34) that can be changed by the input and “corresponding appropriate control signals” (Col. 5, Lines 23-27). Additionally, Wilford teaches where a processor (controller of section 100; Col. 8; Lines 7-19) is configured to:
determine when a deep vein thrombosis prophylaxis treatment modality (thermal therapy section; Col. 2 line 60. Examiner notes that Applicant's specifications [0045] discloses a thermal therapy as a type of DVT prophylaxis) and a compression treatment modality (an air compressor or "DVT section"; Col. 2; Line 61) are both active (The DVT section may also be docked with the thermal therapy section such that the two sections may be used in conjunction with one another; Col. 3; Lines 38-43. One or more of those controllers may also communicate with at lest one memory. Preferably the memory is removable. Data, such as data relating to the operation of sections 100 and 200, may be stored on the memory and subsequently downloaded to an external device by a patient, technician or other person; Col. 7; Lines 41-46);
coordinate timing between the deep vein thrombosis prophylaxis treatment modality and the compression treatment modality (The DVT section may also be docked with the thermal therapy section such that the two sections may be used in conjunction with one another to apply both thermal therapy by pumping a thermal liquid to a wrap from the thermal therapy section as well as applying air compression therapy to a wrap from the DVT section; Col. 3; Lines 38-43. Examiner notes: in a configuration that docking section 200 with section 100 causes the controller of section 100 to override the controller of section 200 such that only control panel 20a of section 100 may be used to control the application of thermal therapy and compression therapy from both sections 100 and 200; Col. 8; Lines 7-19, the controller of section 100 coordinates timing to allow both treatments to be delivered in conjunction); and
control operation of the compression treatment modality based on the operation state of the deep vein thrombosis prophylaxis treatment modality (Examiner notes: in a configuration where application of "both thermal therapy by pumping a thermal liquid to a wrap from the thermal therapy section as well as applying air compression therapy to a wrap from the DVT section" occurs in conjunction, the operation of the DVT section is based on operation of the thermal therapy section and vice versa, to allow the therapies to occur at the same time).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Klopfenstein to include a physical electrical connector, a treatment modality that can be changed when a signal is provided to the physical electrical connector, the change input altering the treatment modality, and the processor being connected to the physical electrical connector and able to determine when a deep vein thrombosis prophylaxis treatment modality and a compression treatment modality are both active, coordinate timing between the deep vein thrombosis prophylaxis treatment modality and the compression treatment modality, and control operation of the compression treatment modality based on the operation state of the deep vein thrombosis prophylaxis treatment modality, as taught by Parish and Wilford, to “allow a plurality of parameters to be specified by a user, such as, for example, the inflated pressure, the deflated pressure, the rate of inflation, the inflation-hold time, and the cycle time” (See Parish, Col. 7; Lines 30-33) and for the purpose of “operating the air compressor in the DVT section without any connection to the thermal therapy section” (See Wilford, Col. 2, Line 67, Col. 3; Lines 1-3), or “such that the two sections may be used in conjunction with one another to apply both thermal therapy…as well as applying air compression therapy” (See Wilford, Col. 3, Lines 38-43), and to “allow the controller to control the entire device and/or can allow for power transfer from the thermal therapy section to the DVT section” (See Wilford, Col. 3; Lines 11-13). Examiner notes: as modified, Klopfenstein-Parish-Wilford teaches sending the signal on the physical electrical connection (See Parish, Col. 10; Lines 28-30) to change the treatment modality of the medical treatment device (See Wilford, Col. 1; Lines 31-34, Col. 5, Lines 23-27) and the recovery data to include the change to the treatment modality of the medical treatment device (See Wilford, ‘record of the machine’s operation’, Col. 1; Lines 31-34, See Klopfenstein, ‘operation instructions’, ‘journals’, ¶0025; Lines 14-20).
Regarding claim 2, Klopfenstein-Parish-Wilford teaches the device of claim 1 as shown above, and further where the at least on wireless communication channel includes Bluetooth (See Klopfenstein, ¶0074; Lines 6-12).
Regarding claim 6, Klopfenstein-Parish-Wilford teaches the device of claim 1 as shown above, furthermore comprising: a second physical electrical connection (‘A’, Fig. A below; adapted Wilford Fig. 5B) for connecting to a wired ‘remote’ controller (See Wilford, 20d, Fig. 5B, Col. 9; Line 64) that is capable of providing the change input to alter the treatment modality of the medical treatment device (See Wilford, Col. 10; Lines 9-12, Examiner notes: “control the operation of section 100 and/or section 200” [Col. 10; Lines 9-12] and embodiments consisting of ‘remote control’/ ‘control panel’ [20A, 20C, 20D] all perform the same function [Col. 5; Lines 23-27, Col. 8; Lines 56-57, Col. 10; Lines 66-69]).
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Fig. A: Wilford Adapted Fig. 5B
Regarding claim 7, Klopfenstein-Parish-Wilford teaches the device of claim 6 as shown above, where the wired ‘remote’ controller has an original connector (‘B’, Fig. A above; adapted Wilford Fig. 5B) and the original connector and the physical electrical connector are the same functionality (See Wilford, ‘signals’, Col. 5; Line 23-27, Examiner Notes: The function of the connector in Wilford is that same as that of the connector of Parish, from claim 1, in that both transfer ‘signals’, as discussed above).
Regarding claim 8, Klopfenstein-Parish-Wilford teaches the device of claim 1 as shown above, where the change input is to start the treatment modality (See Wilford, Col. 1; Lines 31-34).
Regarding claim 9, Klopfenstein-Parish-Wilford teaches the device of claim 1 as shown above, where the periodic send of the recovery data includes encrypting the recovery data (See Klopfenstein, ¶0087; Lines 2-4 & 7-9, ¶0086; Lines 6-8, Examiner notes: Klopfenstein further discusses establishment of an encrypted communication such that all data sent is over an encrypted connection [¶0025; Lines 9-29]).
Regarding claim 13, Klopfenstein-Parish-Wilford teaches the device of claim 1 as shown above, where the recovery data includes the change to the treatment modality of the medical treatment device that provides a compression treatment modality (See Wilford, Col. 2; Lines 60-63).
Regarding claim 15, Klopfenstein-Parish-Wilford teaches the device of claim 13 as shown above, where the wireless communication channel is configured to receive a measurement (See Klopfenstein, ¶0083; Lines 18-33) from a sensor (See Klopfenstein, ¶0102; Lines 15-20) and the processor is configured to store the measurement in the memory as part of the recovery data (See Klopfenstein, ¶0030; Lines 1-8, ¶0109; Lines 1-6).
Claims 3-5, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Klopfenstein et al. (U.S. Pub. No. 2021/0280309 A1), Parish et al. (U.S. Pat. No. 8,778,005 B2) and Wilford et al. (U.S. Pat. No. 8,979,915 B2) as applied to claims 2 and 15 above, and further in view of Amsler et al. (U.S. Pub. No. 2021/0236832 A1, with respect to Prov. App. No. 62/929,721 filed on Nov. 1st, 2019).
Regarding claim 3, Klopfenstein-Parish-Wilford teaches the device of claim 2 as shown above.
Klopfenstein-Parish-Wilford does not teach where the at least one wireless communication channel includes cellular.
However, Amsler teaches a medical device controller with the wireless communication channel including cellular (‘network interface’, ¶0121; Lines 22-25, ¶0083; Lines 4-7).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Klopfenstein-Parish-Wilford to include cellular in the wireless communication channel, as taught by Amsler, such that “the controller protects the components thereunder… …from external environmental impact” (¶0129; Lines 1-8).
Regarding claim 4, Klopfenstein-Parish-Wilford-Amsler teaches the device of claim 3 as shown above, where the periodic sending of the recovery data uses the at least one wireless communication channel (See Klopfenstein, ¶0087; Lines 2-4 and 7-9) that includes cellular (See Amsler, ¶0129; Lines 1-8).
Regarding claim 5, Klopfenstein-Parish-Wilford-Amsler teaches the device of claim 3 as shown above, where the at least one wireless communication channel includes Wi-Fi (See Amsler, ¶0121; Lines 30-32).
Regarding claim 16, Klopfenstein-Parish-Wilford teaches the device of claim 15 as shown above.
Klopfenstein-Parish-Wilford does not teach where the sensor provides movement data.
However, Amsler teaches a medical device controller where the sensor provides movement data (¶0094; Lines 15-20).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Klopfenstein-Parish-Wilford to where the sensor includes movement data, as taught by Amsler, for the purpose of body position being detected for subsequent analysis (¶0094; Lines 16-20).
Regarding claim 17, Klopfenstein-Parish-Wilford teaches the device of claim 15 as shown above.
Klopfenstein-Parish-Wilford does not teach where the sensor provides movement data from an accelerometer.
However, Amsler teaches a medical device controller where the sensor provides movement data (¶0094; Lines 15-20) from an accelerometer (‘vibration sensors’, ¶0094; Lines 13-15).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Klopfenstein-Parish-Wilford where the sensor includes movement data from an accelerometer, as taught by Amsler, for the purpose of body position being detected for subsequent analysis (¶0094; Lines 16-20).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Klopfenstein et al. (U.S. Pub. No. 2021/0280309), Parish et al. (U.S. Pat. No. 8,778,005 B2) and Wilford et al. (U.S. Pat. No. 8,979,915 B2) as applied to claim 2 above, and further in view of Golden (U.S. Pat. No. 9,656,092 B2).
Regarding claim 14, Klopfenstein-Parish-Wilford teaches the device of claim 2 as shown above.
Klopfenstein-Parish-Wilford does not teach where the wireless communication channel includes low energy Bluetooth.
However, Golden teaches methods and systems for managing, controlling and monitoring medical devices where the wireless communication channel includes low energy Bluetooth (Col. 12; Lines 40-43).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Klopfenstein-Parish-Wilford to where the wireless communication channel includes low energy Bluetooth, as taught by Golden, in order to “overcome barriers (e.g., shortcomings related to power consumption) mentioned in the Background section” (Col. 8; Lines 30-32).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Klopfenstein et al. (U.S. Pub. No. 2021/0280309), Parish et al. (U.S. Pat. No. 8,778,005 B2) and Wilford et al. (U.S. Pat. No. 8,979,915 B2) as applied to claim 1 above, and further in view of Parramon (U.S. Pub. No. 2018/0214694 A1).
Regarding claim 18, Klopfenstein-Parish-Wilford teaches the device of claim 1 as shown above, and further where the processor is configured to send a GPS location (See Klopfenstein, ‘GPS coordinates’, ¶0125; Lines 4-5) over the at least one wireless communication channel (See Klopfenstein, ¶0125; Lines 2-6, Examiner notes: Klopfenstein discusses ‘User Journals’ containing GPS location and where ‘journals’ are being sent over the wireless communication channel as applied to claim 1 [¶0087; Lines 2-4 & 7-9]).
Klopfenstein-Parish-Wilford does not explicitly teach the device furthermore comprising: GPS that can provide the GPS location to the processor.
However, Parramon teaches a medical device controller furthermore comprising: GPS that can provide the GPS location to the processor (¶0044; Lines 4-9 and 17-19).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Klopfenstein-Parish-Wilford to further comprise GPS that can provide the GPS location to the processor, as taught by Parramon, such that “the controller 100 may typically be affixed to the patient's wrist… …the inputs received by the microcontroller 172 from the sensor 140 and the motion sensor 175 provide information about the patient that can be utilized to provide closed-loop control of the IPG 10 without initiation by the patient” (¶0046; Lines 1-7).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wilford et al. (U.S. Pat. No. 8,979,915 B2) and Klopfenstein et al. (U.S. Pub. No. 2021/0280309 A1 with respect to Foreign Priority date July 5th, 2018).
Regarding claim 22, Wilford discloses a medical treatment device smart controller (section 100 and section 200; Fig. 1A-5B) comprising:
a physical electrical connector (electrical connection plug 26a and electrical connection plug 26b; Fig. 2A-5B) for connecting to a medical treatment device (Col. 6; Lines 28-41. Examiner notes: section 100 and section 200 act as a medical treatment device by providing elements for applying thermal therapy and compression treatment, respectively) with a treatment modality (Section 100 contains components necessary for applying thermal therapy while section 200 includes components necessary for applying compression therapy; Col. 6; Lines 30-33) that can be changed when a signal is provided to the physical electrical connector (When section 100 and section 200 are docked together, control panel 20 is electrically connected to the electrical components of section 200 as well as to the electrical components of section 100 by virtue of plugs 26a and 26b being connected together; Col. 7; Lines 13-17. Examiner notes: either or both section 100 and section 200 have a control panel for controlling components for applying thermal therapy and/or compression therapy via the connection of the electrical connection plugs 26a/26b that allow communication between elements of section 100 and section 200),
at least one wireless communication channel (signal receiver communicating wirelessly with wireless remote control 20d; see Col. 9 line 63-Col. 10 line 12) that is configured to receive a change input (Operation of the remote control 20d causes the signal emitter of the remote control 20d to emit a signal, preferably coded, that is received by a receiver in section 100. One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10 line 7-12),
a processor (controller of section 100 and/or the controller of section 200) coupled to the wireless communication channel (when activated by a user, the remote control 20d emits a signal that is received by the controller of section 100 and/or the controller of section 200; Col. 9 line 37-Col. 10 line 2) and to the physical electrical connector (When section 100 and section 200 are docked together, control panel 20 is electrically connected to the electrical components of section 200 as well as to the electrical components of section 100 by virtue of plugs 26a and 26b being connected together; Col. 7; Lines 13-17) and configured to process the change input and send the signal on the physical electrical connector to change the treatment modality of the medical treatment device (One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10 line 9-12. Examiner notes: either or both section 100 and section 200 control components for applying thermal therapy and/or compression therapy via the connection of the electrical connection plugs 26a/26b that allow communication between elements of section 100 and section 200),
memory coupled to the processor (Each of sections 100 and 200 may further include one or more memories in communication with the controllers of section 100 and 200 for storing data, such as data relating to the operation of the device. A patient, technician or other person may access the memories and download the data; Col. 6; Lines 11-15), where the processor (controller of section 100 and/or the controller of section 200) is configured to:
receive treatment parameters via the wireless communication channel (Operation of the remote control 20d causes the signal emitter of the remote control 20d to emit a signal, preferably coded, that is received by a receiver in section 100. One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10; Lines 7-12);
store the treatment parameters in the memory (data relating to the operation of the device; Col. 6; Lines 11-15. Examiner notes: data relating to the operation of the device includes treatment parameters received by the controller(s) for applying thermal therapy via components of section 100 and/or applying compression therapy via components of section 200);
control the treatment modality of the medical treatment device based on the stored treatment parameters (data relating to the operation of the device; Col. 6; Lines 11-15. One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10; Lines 7-12).
Wilford is silent as to the processor configured to verify the treatment parameters.
Wilford teaches treatment parameters such as a range of compressive force; Col. 5; Lines 17-20 and 31-34.
Additionally, Klopfenstein teaches a medical device processor configured to verify treatment parameters (The medical device controller 4 may further contain threshold values stored in the memory, the threshold values serving to limit the range of operations that may be executed and instructed for operation of the medical device. For instance, a maximum value for a bolus injection of insulin may be stored so that any dosage instructions exceeding the threshold are limited to the threshold value or a warning is sent to the patient; ¶0086. A safeguards parameters journal (doctor clinical parameters journal) contains safeguards parameters set by the doctor so as to ensure that the user cannot perform certain functions which may have life-threatening consequences. For example, the safeguards parameters may prevent a user to enter a bolus value for insulin injection which is outside a specific range; ¶0127).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the controller of section 100 and/or the controller of section 200 of Wilford to implement verifying the treatment parameters in order to ensure any control instructions fall within a predetermined range of operations and if they exceed the range a warning is sent, as taught by Klopfenstein to improve patient safety ¶0127.
Regarding claim 23, Wilford discloses a medical treatment device smart controller system (section 100 and section 200; Fig. 1A-5B) comprising:
a medical treatment device smart controller (section 100 and section 200; Fig. 1A-5B) with:
a physical electrical connector (electrical connection plug 26a and electrical connection plug 26b; Fig. 2A-5B) for connecting to a medical treatment device (Col. 6; Lines 28-41. Examiner notes: section 100 and section 200 act as a medical treatment device by providing elements for applying thermal therapy and compression treatment, respectively) that provides a treatment modality (Section 100 contains components necessary for applying thermal therapy while section 200 includes components necessary for applying compression therapy; Col. 6; Lines 30-33) where the treatment modality of the medical treatment device changes when a signal is provided to the physical electrical connector (When section 100 and section 200 are docked together, control panel 20 is electrically connected to the electrical components of section 200 as well as to the electrical components of section 100 by virtue of plugs 26a and 26b being connected together; Col. 7; Lines 13-17. Examiner notes: either or both section 100 and section 200 have a control panel for controlling components for applying thermal therapy and/or compression therapy via the connection of the electrical connection plugs 26a/26b that allow communication between elements of section 100 and section 200),
a wireless communication channel (signal receiver communicating wirelessly with wireless remote control 20d; see Col. 9 line 63-Col. 10 line 12) that is configured to receive a change input (Operation of the remote control 20d causes the signal emitter of the remote control 20d to emit a signal, preferably coded, that is received by a receiver in section 100. One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10 line 7-12),
a processor (controller of section 100 and/or the controller of section 200) coupled to the wireless communication channel (when activated by a user, the remote control 20d emits a signal that is received by the controller of section 100 and/or the controller of section 200; Col. 9 line 37-Col. 10 line 2) and to the physical electrical connector (When section 100 and section 200 are docked together, control panel 20 is electrically connected to the electrical components of section 200 as well as to the electrical components of section 100 by virtue of plugs 26a and 26b being connected together; Col. 7; Lines 13-17) and configured to process the change input and send the signal on the physical electrical connector to change the treatment modality of the medical treatment device (One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10 line 9-12. Examiner notes: either or both section 100 and section 200 control components for applying thermal therapy and/or compression therapy via the connection of the electrical connection plugs 26a/26b that allow communication between elements of section 100 and section 200),
memory coupled to the processor (Each of sections 100 and 200 may further include one or more memories in communication with the controllers of section 100 and 200 for storing data, such as data relating to the operation of the device. A patient, technician or other person may access the memories and download the data; Col. 6; Lines 11-15); and
where the processor (controller of section 100 and/or the controller of section 200) is configured to:
receive a command to modify an operating parameter of the treatment modality (Operation of the remote control 20d causes the signal emitter of the remote control 20d to emit a signal, preferably coded, that is received by a receiver in section 100. One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10 line 7-12); and
a portable electronic device that sends the change input to alter the treatment modality of the medical treatment device to the wireless communication channel (Operation of the remote control 20d causes the signal emitter of the remote control 20d to emit a signal, preferably coded, that is received by a receiver in section 100. One or more controllers utilize the signal received to execute control functions and control the operation of section 100 and/or section 200; Col. 10 line 7-12).
Wilford is silent as to where the memory is configured to store one or more threshold values associated with the treatment modality;
where the processor configured to determine if the command would exceed at least one of the threshold values; and
limit execution of the command to conform with the threshold values when the command would exceed the at least one threshold value; and
a remote-control app running on the portable electronic device.
Wilford teaches treatment parameters such as range of compressive force; Col. 5; Lines 17-20 and 31-34.
Additionally, Klopfenstein teaches a medical device controller where the memory is configured to store one or more threshold values (The medical device controller 4 may further contain threshold values stored in the memory; ¶0086);
where the processor is configured to determine if a command would exceed at least one of the threshold values and limit execution of the command to conform with the threshold values when the command would exceed the at least one threshold value (The medical device controller 4 may further contain threshold values stored in the memory, the threshold values serving to limit the range of operations that may be executed and instructed for operation of the medical device. For instance, a maximum value for a bolus injection of insulin may be stored so that any dosage instructions exceeding the threshold are limited to the threshold value or a warning is sent to the patient; ¶0086; also see ¶0127); and
a remote-control app (¶0083; Lines 26-33) running on a portable electronic device (‘consumer electronic device’, ‘smartphone’, ¶0083; Lines 28-29), that sends the change input of the medical treatment device to the wireless communication channel (¶0075; Lines 2-6, ¶0079; Lines 2-4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Wilford to implement the memory storing one or more threshold values associated with the treatment modality, and the controller of section 100 and/or the controller of section 200 to implement determine if a command would exceed at least one of the threshold values and limit execution of the command to conform with the threshold values when the command would exceed the at least one threshold value in order to ensure any control instructions fall within a predetermined range of operations and if they exceed the range a warning is sent, as taught by Klopfenstein to improve patient safety; ¶0127, and to implement a smartphone or consumer electronic device with a software application for controlling the operations of the treatment device, as taught by Klopfenstein; ¶0083.
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.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785