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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/2025 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 11/17/2025. Claims 1, 6, 18, and 27 have been amended. No claims were canceled. Claims 31-32 were newly added.
Response to Arguments
Applicant’s response filed on 11/17/2025 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues A) The combination of Greiner, Kullik, and Nelson does not teach “wherein each sensor of the plurality of sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements”.
5. In response to A) the examiner respectfully disagrees.
At the onset, the Applicant is reminded to view the rejection as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, Nelson does teach this limitation. Nelson discloses sensors (IMD 112) with an antenna incorporated within them (see paragraphs 0038, 0070). This allows for further improvement to the portability of the system. Therefore, the combination of Greiner, Kullik, and Nelson meet the scope of the limitations as currently claimed.
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.
Claims 1-4, 6, 13, 15-18, 26-27, 29, and 31-32 are rejected under 35 U.S.C 103 as being unpatentable over Greiner et al. (US Pub.: 2015/0306409, – Previously Cited) and further in view of Kullik et al. (US Pub.: 2018/0182487, – Previously Cited) and further in view of Nelson et al. (US Pub.: 2001/0023360, – Previously Cited).
Regarding claim 1, Greiner teaches a system for wireless monitoring of patient parameters (e.g. paragraphs 0025-0027), the system comprising:
a plurality of sensors to collect vital sign measurements of a patient (e.g. Figure 3 – element 41; paragraphs 0018, 0030, 0032) and to at least partially process the vital sign measurements for wireless transmission (e.g. paragraph 0021, – “to transmit data acquired by the patient monitoring device wirelessly to the defibrillator device so it can be analyzed and displayed by the defibrillator”; paragraphs 0043-0044; the patient monitoring device has multiple sensors measuring the vital signs and the wireless transmission of the sensor data is processed such as with XML format),
a wireless communication link (e.g. paragraphs 0034-0036);
a therapy module with a defibrillator capability (e.g. paragraph 0031, – the therapy delivery module is construed as a therapy module);
a monitor module (e.g. paragraphs 0036, 0037, – “The patient monitor measurement module 66 is selectively attached to the patient P to receive vital signs and physiological data” “The patient monitor device 10 includes at least a patient monitor display module 62, a data integration module 64, and a patient monitor measurement module 66” The patient monitor device is construed as a monitor module.)
with patient monitoring capability in communication with the therapy module (e.g. paragraphs 0022-023),
the monitor module having a non-transitory computer-readable medium with a plurality of executable instructions stored therein (e.g. paragraph 0029, 0036, – The data integration module 64 of the monitor module is construed as equivalent to data integration module 36) and a processor adapted to execute the plurality of executable instructions to (e.g. paragraphs 0029, – “The data integration module 36 includes a processor 44, a non-transitory computer readable medium 46…The non-transitory computer readable medium 46 stores software or firmware that provides instructions to the data integration module 36, – The data integration module 64 of the monitor module is construed as equivalent to data integration module 36):
receive the vital sign measurements of the plurality of sensors over the wireless communication link (e.g. Figures 2, 5; paragraphs 0043-0046);
generate therapy commands for delivering therapy to the patient and send the therapy commands to the therapy module (e.g. Figure 5 – elements 102-104);
However, Greiner does not explicitly teach and initiating mitigations based on quality of service (QoS) measurements, wherein each sensor of the plurality of sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements;
wirelessly receive the vital sign measurements transmitted by the wireless module of the plurality of sensors over the wireless communication link;
determine a quality of service (QoS) measurement of the wireless communication link used to receive the vital sign measurements from the plurality of sensors;
based on the QoS measurement being below a threshold, initiate a short-term mitigation that includes one or more of providing an alert and determining a modification to the therapy commands;
based on the QoS measurement continuing to remain below the threshold,
subsequently initiate a long-term mitigation that includes employing a secondary communication technique between the plurality of sensors and the monitor module to replace the wireless communication link and control the therapy module according to the therapy commands during the long-term mitigation.
Kullik, in a same field of endeavor of medical devices, discloses and initiating mitigations based on quality of service (QoS) measurements (e.g. paragraphs 0011, 0014, 0030, 0031 – “by taking the data transmission quality into consideration, it is possible to detect a disturbed data transmission between the sender and the medical device and to make the change in the operating parameter or the detection of the alarm generation state contingent hereon” Data transmission quality is equivalent to QoS measurements (Kullik, paragraph 0130)), determine a quality of service (QoS) measurement of the wireless communication link used to receive the vital sign measurements from the plurality of sensors (e.g. paragraph 0030, – “The medical device is preferably characterized in that the processor unit is configured to exchange data messages via the network interface to determine the data transmission quality between the sender and the medical device”);
based on the QoS measurement being below a threshold, initiate a short-term mitigation that includes one or more of providing an alert and determining a modification to the therapy commands (e.g. Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”);
based on the QoS measurement continuing to remain below the threshold (e.g. paragraphs 0115, 0141-0143).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wireless monitoring system of Greiner to incorporate the method of looking at the timing signals with time threshold and time out termination connection, as taught and suggested by Kullik, in order to provide the predictable results of increasing the chances of survival of a patient by having a therapy module continuing to operate despite poor data transmission during short periods of time.
However, Greiner in view of Kullik does not teach wherein each sensor of the plurality of sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements;
wirelessly receive the vital sign measurements transmitted by the wireless module of the plurality of sensors over the wireless communication link;
when QoS measurements continue to stay below a threshold, subsequently initiate a long-term mitigation that includes employing a secondary communication technique between the plurality of sensors and the monitor module to replace the wireless communication link; and control the therapy module according to the therapy commands during the long-term mitigation.
Nelson, in a same field of endeavor of remote communications for medical devices, discloses wherein each sensor (IMD (112) may be oxygen sensors or other physiological monitors) of the plurality of sensors (multiple IMDs; [0038]) has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements (e.g. paragraphs 0038, 0070);
wirelessly transceiving the vital sign measurements transmitted by the wireless module of the plurality of sensors over the wireless communication link (e.g. paragraphs 0038, 0070);
subsequently initiate a long-term mitigation that includes employing a secondary communication technique between the plurality of sensors and the monitor module to replace the wireless communication link (e.g. paragraph 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Greiner in view of Kullik to incorporate a wireless module within each of the sensors as well as the method of initiating a new communication connection, as taught and suggested by Nelson, in order to provide the predictable results of increasing the chances of survival of a patient by having a new communication connection be made between medical devices when poor data transmission persists for long periods of time so that the patient can resume receiving proper treatment and furthermore increases portability of the system.
The combination of Greiner, Kullik, and Nelson teach and control the therapy module according to the therapy commands during the long-term mitigation (Greiner paragraphs 0010-0011, – “wired or serial connection”; Kullik paragraph 0133; Nelson paragraph 0065).
Regarding claim 2, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above and the combination of Greiner in view of Kullik in view of Nelson further teach wherein the short-term mitigation includes determining the modification to the therapy commands (Kullik, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”) and the processor of the monitor module is further adapted to execute the plurality of executable instructions to (Greiner, paragraph 0029, – “The data integration module 36 includes a processor 44, a non-transitory computer readable medium 46…The non-transitory computer readable medium 46 stores software or firmware that provides instructions to the data integration module 36, – The data integration module 64 of the monitor module is construed as equivalent to data integration module 36):
control the therapy module according to the modification to the therapy commands during the short-term mitigation (Greiner paragraphs 0010, 0026, 0029, 0031, – “The node transmits data, e.g., over a wireless connection”; Kullik paragraph 0020, 0133, 0144).
Regarding claim 3, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above and Greiner further teaches wherein generate therapy commands for delivering therapy to the patient comprises the processor of the monitor module executing the plurality of executable instructions to (e.g. Figure 5 – elements 102-104; paragraphs 0029, 0036):
use the vital sign measurements to determine therapy commands for delivering therapy to the patient (e.g. Figure 1 – elements 12, 16, 18; paragraphs 0023, 0040 – “The data integration module 64 also sends information, such as patient age, sex, condition, physiological data and the like via the wireless node 60 to the wireless node 42 for the data integration module 36 and the therapy delivery module 40 to use in determining parameters of the therapy delivered by the therapy delivery module 40”; paragraph 0052 – “With the integrated data, the defibrillator has complete information to make the best therapy related decisions for the patient by way of using the integrated data to directly affect the control of the therapy delivery module”).
Regarding claim 4, Greiner in view of Kullik in view of Nelson teaches the system of claim 1 as discussed above and Greiner further teaches wherein generate therapy commands for delivering therapy to the patient (e.g. Figure 5 – elements 102-104) comprises the processor of the monitor module executing the plurality of executable instructions (e.g. paragraphs 0029, 0036) to:
prompt a user for input including the therapy commands (e.g. paragraph 0031, – “The therapy delivery module 40 is attached to the patient P to perform defibrillation techniques at a user's or device's command depending on the defibrillator mode of operation” ; paragraphs 0033, 0038, 0049, – “Critical data displayed on the defibrillator screen is wirelessly transmitted to the patient monitor…Critical data includes vital signs measurements, physiological alarms, therapy delivery events, and user prompt messages”).
Regarding claim 6, Greiner in view of Kullik in view of Nelson teaches the system of claim 1 as discussed above and Greiner further teaches comprises a defibrillator operable to deliver therapy to the patient including one or more of defibrillation, pacing, and synchronized cardioversion according to the therapy commands (e.g. paragraphs 0010, 0029), wherein the monitor module sends the therapy commands to the therapy module (e.g. paragraphs 0031, 0034). Additionally, Kullik teaches wherein the monitor module and the therapy module are a combined device included within one housing and under control by the processor of the monitor, wherein the monitor module sends the therapy commands to the therapy module over a wired link (e.g. paragraph 0088).
Regarding claim 13, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above and Greiner further teaches wherein the plurality of sensors include power sources (Greiner, paragraphs 0026, 0030, 0032, – the plurality of sensors inherently has power sources).
Regarding claim 15, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above and Nelson further teaches wherein the secondary communication technique includes a wired connection (e.g. paragraph 0032, 0065, 0068 – “communications between IMDNI 116 and remote interrogator 220 may be effected either through a network 230, such as a LAN or the Internet, or communications may be effected through a direct dial-up or dedicated line, or through a terminal connection to a mainframe. These possible implementations are indicated generally by communications link 430. Typically, these connections may be considered alternatives, or both communications links, i.e., relatively direct link 430 and link through network 230 may be implemented in order to provide a backup communications system to the link used as the primary communication method”).
Regarding claim 16, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above and Greiner further teaches further comprising: a transmitter coupled to each of the plurality of sensors (e.g. Fig. 1 – elements 12, 42; paragraph 0006, -“ECG electrodes of the defibrillator are typically also applied to the patient and lead wires must be connected to the defibrillator”) through a wired connection (e.g. paragraph 0011), wherein the transmitter wirelessly transmits the vital sign measurements to the monitor module (e.g. Fig 1 – elements 10, 34, 36, 42, 60, 62).
Regarding claim 17, the Greiner, Kullik and Nelson combination as applied to claim 1 discloses wherein the monitor module (Greiner, paragraphs 0036, 0037) determines the quality of service (QoS) measurement of the wireless communication link by (Kullik, paragraph 0030, – “The medical device is preferably characterized in that the processor unit is configured to exchange data messages via the network interface to determine the data transmission quality between the sender and the medical device”): computing transmission delays based on time stamps (Kullik, paragraph 0031, – “If the quality of the data transmission is too poor, it is possible that a requested parameter value or a requested predefined value was not transmitted correctly or, for example, it was transmitted too slowly, so that a change in the operating parameter or in the predefined value could be disadvantageous for the patient. Such a disadvantageous situation is therefore prevented from occurring by taking the data transmission quality into consideration”; paragraphs 0032-033, 0139) of the vital sign measurements and time of receipt of the vital sign measurements (Kullik paragraph 0015, – “sensor signal, which indicates a physiological parameter of a patient” Physiological parameter of a patient is construed as vital sign measurements; paragraph 0033); and based on the transmission delays, producing the QoS measurement indicative of reliability and latency of the wireless communication link (Kullik, Fig. 7; paragraph 0030, 0141).
Regarding claim 18, Greiner teaches a non-transitory computer-readable medium having stored therein a plurality of executable instructions (e.g. paragraph 0029), which when executed by a monitor module having a processor (e.g. Fig 1 – elements 64,74) causes the monitor module to perform functions comprising: receiving vital sign measurements (e.g. paragraphs 0036, 0037, – “The patient monitor measurement module 66 is selectively attached to the patient P to receive vital signs and physiological data” “The patient monitor device 10 includes at least a patient monitor display module 62, a data integration module 64, and a patient monitor measurement module 66” The patient monitor device is construed as a monitor module.) of a plurality of sensors over a wireless communication link (e.g. Figures 2, 5; paragraphs 0043-0046), wherein the plurality of sensors collect vital sign measurements of a patient (e.g. Figure 3 – element 41; paragraphs 0018, 0030, 0032) and at least partially process the vital sign measurements for wireless transmission (e.g. paragraph 0021, – “to transmit data acquired by the patient monitoring device wirelessly to the defibrillator device so it can be analyzed and displayed by the defibrillator”; paragraphs 0043-0044; the patient monitoring device has multiple sensors measuring the vital signs and the wireless transmission of the sensor data is processed such as with XML format); generating therapy commands for delivering therapy to the patient and sending the therapy commands to a therapy module (e.g. Figure 5 – elements 102-104).
However, Greiner does not explicitly teach wirelessly receiving vital sign measurements transmitted by wireless modules of a plurality of sensors over a wireless communication link, and wherein each sensor of the plurality of sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements; determining a quality of service (QoS) measurement of the wireless communication link used to receive the vital sign measurements from the plurality of sensors; based on the QoS measurement being below a threshold, initiating a short-term mitigation that includes one or more of providing an alert and determining a modification to the therapy commands; based on the QoS measurement continuing to remain below the threshold, subsequently initiating a long-term mitigation that includes employing a secondary communication technique between the plurality of sensors and the monitor module to replace the wireless communication link; and controlling the therapy module according to the therapy commands during the long-term mitigation.
Kullik, in a same field of endeavor of medical devices, discloses determining a quality of service (QoS) measurement of the wireless communication link used to receive the vital sign measurements from the plurality of sensors (e.g. paragraph 0030, – “The medical device is preferably characterized in that the processor unit is configured to exchange data messages via the network interface to determine the data transmission quality between the sender and the medical device”); based on the QoS measurement being below a threshold, initiating a short-term mitigation that includes one or more of providing an alert and determining a modification to the therapy commands (e.g. Fig. 6b paragraphs 0130-0131, 0133, – “ If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”); based on the QoS measurement continuing to remain below the threshold (e.g. paragraphs 0115, 0141-0143).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wireless monitoring system of Greiner to incorporate the method of looking at the timing signals with time threshold and time out termination connection of Kullik in order to provide the predictable results of increasing the chances of survival of a patient by having a therapy module continuing to operate despite poor data transmission during short periods of time.
However, Greiner in view of Kullik does not teach wirelessly receiving vital sign measurements transmitted by wireless modules of a plurality of sensors over a wireless communication link, and wherein each sensor of the plurality of sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements; when QoS measurements continue to stay below a threshold, subsequently initiating a long-term mitigation that includes employing a secondary communication technique between the plurality of sensors and the monitor module to replace the wireless communication link; and controlling the therapy module according to the therapy commands during the long-term mitigation.
Nelson, in a same field of endeavor of remote communications for medical devices, discloses wirelessly transceiving vital sign measurements transmitted by wireless modules of a plurality of sensors over a wireless communication link (e.g. paragraphs 0038, 0070), and wherein each sensor of the plurality of sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements (e.g. paragraphs 0038, 0070); subsequently initiating a long-term mitigation that includes employing a secondary communication technique between the plurality of sensors and the monitor module to replace the wireless communication link (e.g. paragraph 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Greiner in view of Kullik to incorporate a wireless module within each of the sensors as well as the method of initiating a new communication connection, as taught and suggested by Nelson, in order to provide the predictable results of increasing the chances of survival of a patient by having a new communication connection be made between medical devices when poor data transmission persists for long periods of time so that the patient can resume receiving proper treatment and furthermore increases portability of the system.
The combination of Greiner, Kullik, and Nelson teach and controlling the therapy module according to the therapy commands during the long-term mitigation (Greiner paragraphs 0010-0011, – “wired or serial connection”; Kullik paragraph 0133; Nelson paragraph 0065).
Regarding claim 26, the Greiner, Kullik and Nelson combination as applied to claim 18 discloses wherein determining the quality of service (QoS) measurement of the wireless communication link comprises (Kullik, paragraph 0030, – “The medical device is preferably characterized in that the processor unit is configured to exchange data messages via the network interface to determine the data transmission quality between the sender and the medical device”): computing a transmission delay based on time stamps (Kullik, paragraph 0031, – “If the quality of the data transmission is too poor, it is possible that a requested parameter value or a requested predefined value was not transmitted correctly or, for example, it was transmitted too slowly, so that a change in the operating parameter or in the predefined value could be disadvantageous for the patient. Such a disadvantageous situation is therefore prevented from occurring by taking the data transmission quality into consideration”; paragraphs 0032-033, 0139) of the vital sign measurements and time of receipt of the vital sign measurements (Kullik paragraph 0015, – “sensor signal, which indicates a physiological parameter of a patient” Physiological parameter of a patient is construed as vital sign measurements; paragraph 0033); and based on the transmission delay, producing the QoS measurement indicative of reliability and latency of the wireless communication link (Kullik, Fig. 7; paragraph 0030, 0141).
Regarding claim 27, Greiner teaches a system for wireless monitoring of patient parameters (e.g. paragraphs 0025-0027), the system comprising: one or more sensors to collect vital sign measurements of a patient (e.g. Figure 3 – element 41; paragraphs 0018, 0030, 0032) and to at least partially process the vital sign measurements for wireless transmission (e.g. paragraph 0021, – “to transmit data acquired by the patient monitoring device wirelessly to the defibrillator device so it can be analyzed and displayed by the defibrillator”; paragraphs 0043-0044; the patient monitoring device has multiple sensors measuring the vital signs and the wireless transmission of the sensor data is processed such as with XML format)
a wireless communication link (e.g. paragraphs 0034-0036);
a monitor module (e.g. paragraphs 0036, 0037, – “The patient monitor measurement module 66 is selectively attached to the patient P to receive vital signs and physiological data” “The patient monitor device 10 includes at least a patient monitor display module 62, a data integration module 64, and a patient monitor measurement module 66” The patient monitor device is construed as a monitor module.)
with patient monitoring capability (e.g. paragraphs 0022-023),
the monitor module having a non-transitory computer-readable medium with a plurality of executable instructions stored therein (e.g. paragraph 0029, 0036, – The data integration module 64 of the monitor module is construed as equivalent to data integration module 36) and a processor adapted to execute the plurality of executable instructions to (e.g. paragraphs 0029, – “The data integration module 36 includes a processor 44, a non-transitory computer readable medium 46…The non-transitory computer readable medium 46 stores software or firmware that provides instructions to the data integration module 36, – The data integration module 64 of the monitor module is construed as equivalent to data integration module 36):
receive the vital sign measurements of the one or more sensors over the wireless communication link (e.g. Figures 2, 5; paragraphs 0043-0046);
generate therapy commands for delivering therapy to the patient (e.g. Figure 5 – elements 102-104).
However, Greiner does not explicitly teach and initiating mitigations based on quality of service (QoS) measurements, wherein each sensor of the one or more sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements; wirelessly receive the vital sign measurements transmitted by the wireless module of the one or more sensors over the wireless communication link; determine a quality of service (QoS) measurement of the wireless communication link used to receive the vital sign measurements from the plurality of sensors; and based on the QoS measurement being below a threshold, initiate a mitigation that includes one or more of (i) providing an alert, (ii) determining a modification to the therapy commands, and (iii) employing a secondary communication technique between the one or more sensors and the monitor module to replace the wireless communication link.
Kullik, in a same field of endeavor of medical devices, discloses and initiating mitigations based on quality of service (QoS) measurements (e.g. paragraphs 0011, 0014, 0030, 0031 – “by taking the data transmission quality into consideration, it is possible to detect a disturbed data transmission between the sender and the medical device and to make the change in the operating parameter or the detection of the alarm generation state contingent hereon” Data transmission quality is equivalent to QoS measurements (Kullik, paragraph 0130)), determine a quality of service (QoS) measurement of the wireless communication link used to receive the vital sign measurements from the plurality of sensors (e.g. paragraph 0030, – “The medical device is preferably characterized in that the processor unit is configured to exchange data messages via the network interface to determine the data transmission quality between the sender and the medical device”); and based on the QoS measurement being below a threshold, initiate a mitigation that includes one or more of (i) providing an alert, (ii) determining a modification to the therapy commands (e.g. Fig. 6b paragraphs 0071, 0130-0131, 0133, – “ If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wireless monitoring system of Greiner to incorporate the method of looking at the timing signals with time threshold and time out termination connection of Kullik in order to provide the predictable results of increasing the chances of survival of a patient by having a therapy module continuing to operate despite poor data transmission during short periods of time.
However, Greiner in view of Kullik does not teach wherein each sensor of the one or more sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements; wirelessly receive the vital sign measurements transmitted by the wireless module of the one or more sensors over the wireless communication link; and (iii) employing a secondary communication technique between the one or more sensors and the monitor module to replace the wireless communication link.
Nelson, in a same field of endeavor of remote communications for medical devices, discloses wherein each sensor of the one or more sensors has a wireless module incorporated within the sensor for wirelessly transmitting the vital sign measurements (e.g. paragraphs 0038, 0070); wirelessly transceive the vital sign measurements transmitted by the wireless module of the one or more sensors over the wireless communication link (e.g. paragraphs 0038, 0070); and (iii) employing a secondary communication technique between the one or more sensors and the monitor module to replace the wireless communication link (e.g. paragraph 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated)”.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Greiner in view of Kullik to incorporate a wireless module within each of the sensors as well as the method of initiating a new communication connection, as taught and suggested by Nelson, in order to provide the predictable results of increasing the chances of survival of a patient by having a new communication connection be made between medical devices when poor data transmission persists for long periods of time so that the patient can resume receiving proper treatment and furthermore increases portability of the system.
Regarding claim 29, the Greiner, Kullik and Nelson combination as applied to claim 27 discloses wherein determining the quality of service (QoS) measurement of the wireless communication link comprises (Kullik, paragraph 0030, – “The medical device is preferably characterized in that the processor unit is configured to exchange data messages via the network interface to determine the data transmission quality between the sender and the medical device”): computing transmission delays based on time stamps (Kullik, paragraph 0031, – “If the quality of the data transmission is too poor, it is possible that a requested parameter value or a requested predefined value was not transmitted correctly or, for example, it was transmitted too slowly, so that a change in the operating parameter or in the predefined value could be disadvantageous for the patient. Such a disadvantageous situation is therefore prevented from occurring by taking the data transmission quality into consideration”; paragraphs 0032-033, 0139) of the vital sign measurements and time of receipt of the vital sign measurement (Kullik paragraph 0015, – “sensor signal, which indicates a physiological parameter of a patient” Physiological parameter of a patient is construed as vital sign measurements; paragraph 0033); and based on the transmission delays, producing the QoS measurement indicative of reliability and latency of the wireless communication link (Kullik, Fig. 7; paragraph 0030, 0141).
Regarding claim 31, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above and Nelson further teaches wherein the wireless communication link is a direct wireless communication link between the monitor module and each sensor of the plurality of sensors (e.g. paragraphs 0038, 0070).
Regarding claim 32, Greiner in view of Kullik in view of Nelson teach the system of claim 1 as discussed above, and Nelson further teaches wherein the wireless module incorporated within each sensor of the plurality of sensors includes a radio module with an antenna to wirelessly transmit the vital sign measurements (e.g. paragraphs 0038, 0070).
Claims 7-9 are rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claim 6 above, and further in view of Delisle et al. (US Pub.: 2018/0036543, – Previously Cited).
Regarding claim 7 Greiner in view of Kullik in view of Nelson teach the system of claim 6 as discussed above, and Kullik further teaches wherein the short-term mitigation includes modifying operation of the defibrillator to switch to (e.g. abstract, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”).
However, Greiner in view of Kullik in view of Nelson does not explicitly teach non-demand pacing for a specific time duration.
Delisle, in a same field of endeavor of wireless defibrillators, discloses non-demand pacing for a specific time duration (e.g. paragraph 0118, – “the user can push a button to change to “fixed pacing” Fixed pacing is construed as non-demand pacing).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Greiner in view of Kullik in view of Nelson to incorporate the fixed pacing setting of Delisle in order to provide the predictable results of consistently providing pace pulses regardless of a patient’s intrinsic rhythm (Delisle, paragraph 0118).
Regarding claim 8, Greiner in view of Kullik in view of Nelson teach the system of claim 6 as discussed above, and Kullik further teaches wherein the short-term mitigation includes modifying operation of the defibrillator to switch to (e.g. abstract, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”).
However, Greiner in view of Kullik in view of Nelson does not explicitly teach an automated external defibrillator (AED) mode.
Delisle, in a same field of endeavor of wireless defibrillators, discloses an automated external defibrillator (AED) mode (e.g. paragraphs 0003, 0009, 0010).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Greiner in view of Kullik in view of Nelson to incorporate the AED mode of Delisle in order to provide the predictable results of caregivers with basic life support training to be able to deliver a defibrillation shock, that includes an automatic ECG analysis to determine whether a shock is advised (Delisle, paragraph 0010).
Regarding claim 9, Greiner in view of Kullik in view of Nelson teach the system of claim 6 as discussed above, and Kullik further teaches wherein the short-term mitigation includes modifying operation of the defibrillator to disable (e.g. abstract, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”).
However, Greiner in view of Kullik in view of Nelson does not explicitly teach synchronized-cardioversion.
Delisle, in a same field of endeavor of wireless defibrillators, discloses synchronized-cardioversion (e.g. paragraphs 0007-0008).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Greiner in view of Kullik in view of Nelson to incorporate the synchronized cardioversion defibrillator mode of Delisle in order to provide the predictable results of delivering a synchronized shock to treat arrhythmias such as atrial fibrillation (Delisle, paragraph 0008).
Claims 10, 14 are rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claim 1 above, and further in view of Davis et al. (US Pub.: 2012/0229271, – Previously Cited).
Regarding claim 10, Greiner teaches wherein the monitor module includes a control and display module (e.g. Figure 2; paragraph 0040, – the display controller 72 is construed as a control module.), and the therapy module is a separate component from the monitor module (e.g. Figure 2), wherein the therapy module is operable to deliver therapy to the patient including one or more of defibrillation, pacing, and synchronized cardioversion (e.g. paragraph 0029, – “The defibrillator device 12 can include different modes of operation including manual mode, a fully automatic mode, a monitoring mode, and a pacer mode”) according to the therapy commands (e.g. paragraph 0031, – “The therapy delivery module 40 is attached to the patient P to perform defibrillation techniques at a user's or device's command depending on the defibrillator mode of operation”) wherein the therapy module is in wireless communication (e.g. Figure 2; paragraphs 0034-0036, 0056) with the control and display module to receive the therapy commands (e.g. Figure 2; paragraphs 0034-0036, 0056). The combination of Greiner, Kullik, and Nelson, as applied to claim 1, does not disclose wireless communication over a second wireless communication link.
Davis, in a same field of endeavor of wireless monitoring systems, discloses wireless communication over a second wireless communication link (e.g., Figure 1; paragraph 0032, – “In some embodiments, the use of the primary transmitter 42 is mutually exclusive from the use of the secondary transmitter 43. In those embodiments, the secondary transmitter 43 is used instead of the primary transmitter 42 when the primary transmitter 42 is not connected, or reliably connected, to the primary wireless network 10. Alternatively, the primary transmitter 42 and secondary transmitter 43 could be used simultaneously.”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to include wireless communication over a second wireless communication link, as taught and suggested by Davis, for the purpose of having an additional connection capable of transmitting and receiving information (Davis, Figure 1; paragraphs 0022, 0033).
Regarding claim 14, the Greiner, Kullik, and Nelson combination teaches the system of claim 1 as discussed above except for wherein the secondary communication technique includes a short-range wireless communication.
Davis, in a same field of endeavor of wireless monitoring systems, discloses wherein the secondary communication technique includes a short-range wireless communication (e.g. abstract, paragraphs 0032, 0049 – “the secondary wireless network 20 operates in the infrared frequency spectrum. In that embodiment, the secondary transmitter 43 is configured to transmit a frequency range that is in the infrared frequency spectrum” Infrared is construed as a short-range wireless communication).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Greiner in view of Kullik in view of Nelson to incorporate the use of infrared frequency by the secondary transmitter, as taught and suggested by Davis, in order to provide the predictable results of having a back-up connection when the primary connection is not connected, or reliably connected (Davis, paragraph 0032).
Claims 5, 28 are rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claims 1, 27 above, and further in view of Shusterman (US Pub.: 2019/0159733, – Previously Cited). Regarding claim 5, Greiner teaches wherein the wireless communication link is provided by the monitor module (e.g. paragraph 0036) and includes one of Bluetooth or Wi-Fi communications, and wherein the monitor module selects one of the Bluetooth or Wi-Fi communications (e.g. Figure 5; paragraph 0035, – “device selection and data transmission can be completed using communication standards like the WPS, Wi-Fi (IEEE 802.11), Bluetooth, IEEE 802.15.4, ZigBee, 6LoWPAN protocols or the like”; paragraph 0045, - “Step 88 a wireless interconnection 20 is established with the selected patient monitor 10”). The combination of Greiner, Kullik, and Nelson, as applied to claim 1, does not disclose for use based on a type of the plurality of sensors in use.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses that the monitor module selects one of the Bluetooth or Wi-Fi communications for use based on a type of the plurality of sensors in use (e.g. Fig. 23; paragraph 0210 – “For example, Module #1 provides multi-channel acquisition of ECG data, whereas Module #2 provides multi-channel acquisition of blood pressure and pulse-oximetry data. For systems with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems), the number of modules can be further increased, as required”; paragraph 0216 – “wireless transmission includes intelligent, “on-demand” re-routing of data from failed wireless links (transmitters) to working ones. Examples of such wireless transmitters include: (i) transmitters of the same type (e.g., two Bluetooth transmitters), (ii) transmitters of different types (e.g., Bluetooth and Wi-Fi), and (iii) transmitters of the same type but with different transmission frequencies (e.g., Wi-Fi operating on 2.4 and 5.2 GHz)”)
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to incorporate the method of utilizing different wireless protocols for multiple modules, as taught and suggested by Shusterman, in order to provide the predictable results of ensuring that the data will be received by one or more receivers utilizing one of the transmission frequencies, even if the second transmission link fails (Shusterman, paragraph 0215).
Regarding claim 28, Greiner teaches wherein the wireless communication link is provided by the monitor module (e.g. paragraph 0036) and includes one of Bluetooth or Wi-Fi communications, and the monitor module selects one of the Bluetooth or Wi-Fi communications (e.g. Figure 5; paragraph 0035, – “device selection and data transmission can be completed using communication standards like the WPS, Wi-Fi (IEEE 802.11), Bluetooth, IEEE 802.15.4, ZigBee, 6LoWPAN protocols or the like”; paragraph 0045, - “Step 88 a wireless interconnection 20 is established with the selected patient monitor 10”). The combination of Greiner, Kullik, and Nelson, as applied to claim 27, does not disclose for use based on a type of the one or more sensors in use.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses that the monitor module selects one of the Bluetooth or Wi-Fi communications for use based on a type of the one or more of sensors in use (e.g. Fig. 23; paragraph 0210 – “For example, Module #1 provides multi-channel acquisition of ECG data, whereas Module #2 provides multi-channel acquisition of blood pressure and pulse-oximetry data. For systems with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems), the number of modules can be further increased, as required”; paragraph 0216 – “wireless transmission includes intelligent, “on-demand” re-routing of data from failed wireless links (transmitters) to working ones. Examples of such wireless transmitters include: (i) transmitters of the same type (e.g., two Bluetooth transmitters), (ii) transmitters of different types (e.g., Bluetooth and Wi-Fi), and (iii) transmitters of the same type but with different transmission frequencies (e.g., Wi-Fi operating on 2.4 and 5.2 GHz)”)
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to incorporate the method of utilizing different wireless protocols for multiple modules, as taught and suggested by Shusterman, in order to provide the predictable results of ensuring that the data will be received by one or more receivers utilizing one of the transmission frequencies, even if the second transmission link fails (Shusterman, paragraph 0215).
Claims 11-12 are rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson and further in view of Davis as applied to claim 10 above, and further in view of Shusterman.
Regarding claim 11, Nelson teaches wherein the long-term mitigation
between the monitor module and therapy module (Nelson, Fig 3 – elements 112, 322; paragraphs 0006, 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated)”. The combination of Greiner, Kullik, Nelson, and Davis as applied above to claim 10, does not disclose that the long-term mitigation further includes employing a further secondary channel.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses that the long-term mitigation further includes employing a further secondary channel (e.g. Figure 23, paragraphs 0210, 0216 – “For systems with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems), the number of modules can be further increased, as required”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, Nelson, and Davis combination to include the additional modules with wireless transmission, as taught and suggested by Shusterman, for the purpose of acquiring physiological data with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems) (Shusterman 0216).
Regarding claim 12, the Greiner, Kullik, Nelson, and Davis combination as applied to claim 10 discloses and wherein the therapy module analyzes time stamps in the therapy commands (Kullik: paragraphs 0032, 0033, 0133, 0139) as well as
for determination of a second QoS measurement based on the second QoS measurement satisfying the threshold,
and based on the second QoS measurement not satisfying the threshold, the therapy module delays therapy until the second QoS measurement satisfies the threshold.(Nelson: paragraphs 0065, 0068, 0071, 0073 – “it may be advisable to monitor the baud rate. This feature would then allow for a detection or early warning mechanism to be in place to alert the user of any difficulty with system capacity…Therefore, if a prescribed threshold, quality of services parameters/algorithms… then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated either automatically...this feature would continue to monitor the baud rate and take appropriate action if a change is noted which is within or approaching a threshold”) and of the second wireless communication link (Davis: Figure 1; paragraph 0032) but does not disclose wherein the therapy includes synchronized cardioversion in which the plurality of sensors include wireless electrocardiogram (ECG) leads, the therapy module delivers sync-cardio therapy according to the therapy commands.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses wherein the therapy includes synchronized cardioversion in which the plurality of sensors include wireless electrocardiogram (ECG) leads (e.g. Fig. 1 – elements 25, 40; paragraphs 0203, 0247, 0249), the therapy module delivers sync-cardio therapy according to the therapy commands (e.g. paragraph 0059 – “cardiovascular monitoring (e.g., ECG, blood pressure, pulse oximetry) in order to evaluate cardiac rhythm before and after defibrillation (electrical discharge or shock) or cardiac pacing, to detect cardiac arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia, atrial fibrillation), or to perform a cardioversion (i.e., a synchronized shock delivered at a specific time point of the cardiac cycle, usually within the QRS complex on the ECG”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, Nelson, and Davis combination to include the method of performing a cardioversion and using wireless ECG leads, as taught and suggested by Shusterman, for the purpose of treating an abnormal heartbeat (Shusterman 0059).
Claim 19 is rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claim 18 above, and further in view of Shusterman.
Regarding claim 19, Greiner teaches wherein the wireless communication link (e.g. paragraph 0036) includes one of Bluetooth or Wi-Fi communications (e.g. Figure 5; paragraph 0035, – “device selection and data transmission can be completed using communication standards like the WPS, Wi-Fi (IEEE 802.11), Bluetooth, IEEE 802.15.4, ZigBee, 6LoWPAN protocols or the like”; paragraph 0045, - “Step 88 a wireless interconnection 20 is established with the selected patient monitor 10”), and the functions further comprise: selecting one of the Bluetooth or Wi-Fi communications for use based on a type of the plurality of sensors in use.
However, the combination of Greiner, Kullik, and Nelson, as applied to claim 18, does not disclose and the functions further comprise: selecting one of the Bluetooth or Wi-Fi communications for use based on a type of the plurality of sensors in use.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses and the functions further comprise: selecting one of the Bluetooth or Wi-Fi communications for use based on a type of the plurality of sensors in use (e.g. Fig. 23; paragraph 0210 – “For example, Module #1 provides multi-channel acquisition of ECG data, whereas Module #2 provides multi-channel acquisition of blood pressure and pulse-oximetry data. For systems with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems), the number of modules can be further increased, as required”; paragraph 0216 – “wireless transmission includes intelligent, “on-demand” re-routing of data from failed wireless links (transmitters) to working ones. Examples of such wireless transmitters include: (i) transmitters of the same type (e.g., two Bluetooth transmitters), (ii) transmitters of different types (e.g., Bluetooth and Wi-Fi), and (iii) transmitters of the same type but with different transmission frequencies (e.g., Wi-Fi operating on 2.4 and 5.2 GHz)”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Greiner, Kullik and Nelson combination to include the method of utilizing different wireless protocols for multiple modules, as taught and suggested by Shusterman, in order to provide the predictable results of ensuring that the data will be received by one or more receivers utilizing one of the transmission frequencies, even if the second transmission link fails (Shusterman, paragraph 0215).
Claims 20-22 are rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claim 18 above, and further in view of Delisle.
Regarding claim 20, the Greiner, Kullik, and Nelson combination as applied to claim 18 discloses wherein the monitor module and the therapy module are a combined device which comprises a defibrillator operable to deliver therapy to the patient (Greiner: Figure 2; paragraph 0010 – “In accordance with one preferred embodiment of the present application, a defibrillation apparatus comprises a measurement module; a therapy delivery module; a display module; a transmission node; and a data integration module. The measurement module receives input data from a patient” The display module is construed as a monitor module) including one or more of defibrillation, pacing, and synchronized cardioversion (Greiner: paragraph 029, – “The defibrillator device 12 can include different modes of operation including manual mode, a fully automatic mode, a monitoring mode, and a pacer mode”) according to the therapy commands (Greiner: paragraphs 0031, 0034, – “The data integration module 36 receives data that is collected by the measurement module 34 and data input from the user interface 38 and sends instructions to the therapy delivery module 40 to apply therapy, and outputs a display signal to the display module 38”), as well as and wherein initiating the short-term mitigation includes modifying operation of the defibrillator to switch to (Kullik: abstract, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”) but does not disclose non-demand pacing for a specific time duration.
Delisle, in a same field of endeavor of wireless defibrillators, discloses non-demand pacing for a specific time duration (e.g. paragraph 0118, – “the user can push a button to change to “fixed pacing” Fixed pacing is construed as non-demand pacing).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to incorporate the fixed pacing setting of Delisle in order to provide the predictable results of consistently providing pace pulses regardless of a patient’s intrinsic rhythm (Delisle, paragraph 0118).
Regarding claim 21, the Greiner, Kullik, and Nelson combination as applied to claim 18 discloses wherein the monitor module and the therapy module are a combined device which comprises a defibrillator operable to deliver therapy to the patient (Greiner: Figure 2; paragraph 0010 – “In accordance with one preferred embodiment of the present application, a defibrillation apparatus comprises a measurement module; a therapy delivery module; a display module; a transmission node; and a data integration module. The measurement module receives input data from a patient” The display module is construed as a monitor module) including one or more of defibrillation, pacing, and synchronized cardioversion (Greiner: paragraph 029, – “The defibrillator device 12 can include different modes of operation including manual mode, a fully automatic mode, a monitoring mode, and a pacer mode”) according to the therapy commands (Greiner: paragraphs 0031, 0034, – “The data integration module 36 receives data that is collected by the measurement module 34 and data input from the user interface 38 and sends instructions to the therapy delivery module 40 to apply therapy, and outputs a display signal to the display module 38”), as well as and wherein initiating the short-term mitigation includes modifying operation of the defibrillator to switch to (Kullik: abstract, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”) but does not disclose an automated external defibrillator (AED) mode.
Delisle, in a same field of endeavor of wireless defibrillators, discloses an automated external defibrillator (AED) mode (e.g. paragraphs 0003, 0009, 0010).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to incorporate the AED mode of Delisle in order to provide the predictable results of caregivers with basic life support training to be able to deliver a defibrillation shock, that includes an automatic ECG analysis to determine whether a shock is advised (Delisle, paragraph 0010).
Regarding claim 22, the Greiner, Kullik, and Nelson combination as applied to claim 18 discloses wherein the monitor module and the therapy module are a combined device which comprises a defibrillator operable to deliver therapy to the patient (Greiner: Figure 2; paragraph 0010 – “In accordance with one preferred embodiment of the present application, a defibrillation apparatus comprises a measurement module; a therapy delivery module; a display module; a transmission node; and a data integration module. The measurement module receives input data from a patient” The display module is construed as a monitor module) including one or more of defibrillation, pacing, and synchronized cardioversion (Greiner: paragraph 029, – “The defibrillator device 12 can include different modes of operation including manual mode, a fully automatic mode, a monitoring mode, and a pacer mode”) according to the therapy commands (Greiner: paragraphs 0031, 0034, – “The data integration module 36 receives data that is collected by the measurement module 34 and data input from the user interface 38 and sends instructions to the therapy delivery module 40 to apply therapy, and outputs a display signal to the display module 38”), as well as and wherein initiating the short-term mitigation includes modifying operation of the defibrillator to disable (Kullik: abstract, Fig. 6b paragraphs 0130-0131, 0133, – “If the data transmission quality is not sufficient, the medical device MV1 is put into a so-called basic state or basic operating parameter”) but does not disclose synchronized-cardioversion.
Delisle, in a same field of endeavor of wireless defibrillators, discloses synchronized-cardioversion (e.g. paragraph 0007-0008).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to incorporate the synchronized-cardioversion mode of Delisle in order to provide the predictable results of delivering a synchronized shock to treat arrhythmias such as atrial fibrillation (Delisle, paragraph 0008).
Claim 23 is rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claim 18 above, and further in view of Davis.
Regarding claim 23, Greiner teaches wherein the monitor module includes a control and display module (e.g. Figure 2; paragraph 0040, – the display controller 72 is construed as a control module.), and the therapy module is a separate component from the monitor module (e.g. Figure 2), and the functions further comprise: the control and display module wirelessly transmitting the therapy commands to a therapy module (e.g. Figure 2; paragraphs 0034-0036, 0056). The combination of Greiner, Kullik, and Nelson, as applied to claim 18, does not disclose wireless communication over a second wireless communication link.
Davis, in a same field of endeavor of wireless monitoring systems, discloses wireless communication over a second wireless communication link (e.g., Figure 1; paragraph 0032, – “In some embodiments, the use of the primary transmitter 42 is mutually exclusive from the use of the secondary transmitter 43. In those embodiments, the secondary transmitter 43 is used instead of the primary transmitter 42 when the primary transmitter 42 is not connected, or reliably connected, to the primary wireless network 10. Alternatively, the primary transmitter 42 and secondary transmitter 43 could be used simultaneously.”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to include wireless communication over a second wireless communication link, as taught and suggested by Davis, for the purpose of having an additional connection capable of transmitting and receiving information (Davis, Figure 1; paragraphs 0022, 0033).
Claims 24-25 are rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson and further in view of Davis as applied to claim 23 above, and further in view of Shusterman.
Regarding claim 24, Nelson teaches wherein initiating the long-term mitigation and between the monitor module and therapy module (Nelson, Fig 3 – elements 112, 322; paragraphs 0006, 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated)”. The combination of Greiner, Kullik, Nelson, and Davis as applied above to claim 23, does not disclose that the long-term mitigation further includes employing a further secondary channel.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses that the long-term mitigation further includes employing a further secondary channel (e.g. Figure 23, paragraphs 0210, 0216 – “For systems with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems), the number of modules can be further increased, as required”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, Nelson, and Davis combination to include the additional modules with wireless transmission, as taught and suggested by Shusterman, for the purpose of acquiring physiological data with a large number of data channels (e.g., cardiac electrophysiology, EMG, or EEG monitoring systems) (Shusterman 0216).
Regarding claim 25, the Greiner, Kullik, Nelson, and Davis combination as applied to claim 23 discloses and wherein initiating the long-term mitigation further includes: (Nelson, Fig 3 – elements 112, 322; paragraphs 0006, 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated)” as well as analyzing time stamps in the therapy commands (Kullik: paragraphs 0032, 0033, 0133, 0139) and
for determination of a second QoS measurement, based on the second QoS measurement satisfying the threshold, and based on the second QoS measurement not satisfying the threshold, delaying therapy until the second QoS measurement satisfies the threshold (Nelson: paragraphs 0065, 0068, 0071, 0073 – “it may be advisable to monitor the baud rate. This feature would then allow for a detection or early warning mechanism to be in place to alert the user of any difficulty with system capacity…Therefore, if a prescribed threshold, quality of services parameters/algorithms… then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated either automatically...this feature would continue to monitor the baud rate and take appropriate action if a change is noted which is within or approaching a threshold”) and of the second wireless communication link (Davis: Figure 1; paragraph 0032) but does not disclose wherein the therapy includes synchronized cardioversion in which the plurality of sensors include wireless electrocardiogram (ECG) leads, delivering sync-cardio therapy according to the therapy commands.
Shusterman, in a same field of endeavor of wireless health monitoring systems, discloses wherein the therapy includes synchronized cardioversion in which the plurality of sensors include wireless electrocardiogram (ECG) leads (e.g. Fig. 1 – elements 25, 40; paragraphs 0203, 0247, 0249), delivering sync-cardio therapy according to the therapy commands (e.g. paragraph 0059 – “cardiovascular monitoring (e.g., ECG, blood pressure, pulse oximetry) in order to evaluate cardiac rhythm before and after defibrillation (electrical discharge or shock) or cardiac pacing, to detect cardiac arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia, atrial fibrillation), or to perform a cardioversion (i.e., a synchronized shock delivered at a specific time point of the cardiac cycle, usually within the QRS complex on the ECG”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, Nelson, and Davis combination to include the method of performing a cardioversion and using wireless ECG leads, as taught and suggested by Shusterman, for the purpose of treating an abnormal heartbeat (Shusterman 0059).
Claim 30 is rejected under 35 U.S.C 103 as being unpatentable over Greiner and further in view of Kullik and further in view of Nelson as applied to claim 27 above, and further in view of Sarkar et al. (US Pub.: 2016/0235317, – Previously Cited).
Regarding claim 30, Nelson teaches wherein employing the secondary communication technique between the one or more sensors and the monitor module to replace the wireless communication link comprises: (e.g. paragraph 0065, – “if a prescribed threshold, quality of service parameters/algorithms … or margin of safety for baud rate is acceptable, then the communication session would be allowed to continue. If not, then termination may be suggested by any of various alert mechanisms, prompts, or automatic sequences. A new connection could be initiated”). The combination of Greiner, Kullik, and Nelson, as applied to claim 27, does not disclose employing an electromagnetic coupling communication.
Sarkar, in a same field of endeavor of medical devices, discloses employing an electromagnetic coupling communication (e.g. paragraph 0051, – “Communication module 46 may be configured to transmit and receive communication signals via inductive coupling, electromagnetic coupling, tissue conductance, Near Field Communication (NFC)”).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the Greiner, Kullik, and Nelson combination to incorporate the use of electromagnetic coupling communication, as taught and suggested by Sarkar, in order to provide the predictable results of a communication module having an additional method to transmit and receive communication signals such as electrical signal data (e.g. ECG signal data) with an external device (Sarkar, paragraph 0051).
Conclusion
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792