DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/20/2025 has been entered.
Response to Arguments
The amendment to claims 2 and 20 are sufficient to overcome the previous 112 rejection.
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive.
Regarding 101, the applicant argues that the claims do not recite an abstract idea. In the instant invention the abstract idea requires determining at least two of the following qualification tests (obtained by sensors) over a first evaluation period:(1) detecting an impedance for at least one electrical path that includes at least one electrode of the implantable medical lead, and comparing the impedance to a first predetermined impedance threshold to determine a connection status of the IMD to the at least one electrode;(2) comparing, over an EGM test period, at least one EGM event of the patient against a first predetermined EGM event threshold;(3) controlling the signal generator and the sensing circuitry to determine a first pacing capture threshold (PCT); and(4) detecting at least one clinical or patient-specific physiologic metric, and comparing the physiologic metric to a first predetermined physiologic metric threshold. Unlike in Thales, the instant claims comprising an IMD with sensors are being recited in a conventional manner. Regarding the argument that the human mind is not equipped to initiate test sequence of using detected impedance data and comparing it to a respective threshold or comparing at least one EGM event of the patient against a threshold, or using data from a sensor to determine a pacing capture threshold or using sensors to detect a physiological metric and comparing it to a predetermined metric threshold is not persuasive. The examiner notes that comparing data to a threshold is easily performed by the mind (e.g. is 5 more than 10?) Doctors use this technique when analyzing data and can look at an EGM and identify anomalies, e.g. determine a P-wave is inverted by comparing it to a standard EGM waveform. The ability to look at one sequence and then look at a second sequence is also within the scope of a mental process as it is common for practitioners to perform the steps again and look for the same and/or additional data to confirm their findings. The examiner notes that MPEP 2106.05(a)(II) states “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” The examiner notes that obtaining and using sensor data, including EGM data and impedance measurements, are routinely performed by IMD’s (for example see, Jorgenson (US Publication 2002/0120307), Gunderson (US Publication 2014/0277229) and Prutchi et al (US Patent 5,531,772)) and does not appear to be an improvement in monitoring technology.
Under step 2a, prong 2 Applicant argues the additional elements are that it improves the functioning of a computer or an improvement to any other technology or technical field. This is achieved by taking larger complicated data to provide a more accurate picture of the implant performance and increase confidence in the implant procedure. Applicant argues customary practice often includes a PCT qualification test and another example is a qualification tests based on one or more sensed cardiac events. However, the data at uplink might include incomplete or inaccurate results. Therefore, automatically performing clinically necessary device qualification test to assess implant success can facilitate same day discharge and improve patient outcomes. Applicant agues claim 1 recites novel testing not previously performed and thus does not automate tests but automatically performs clinically necessary device qualification tests. The examiner respectfully disagrees as the processor is performing qualification tests customarily practiced by medical personnel. While automation does make it more convenient, the arguments have not identified any additional elements that demonstrate the claim as a whole integrates the exception into a practical application. The examiner notes that impedance sensing, sensing circuitry to sense EGM signal of a patient, and a signal generator to evaluate PCT are pre-solution activities for the processor to evaluate the signals following qualification tests over an evaluation period. The Applicant highlights the steps performed by the processor of a first qualification test, transmitting the results and performing a second qualification test, which is different, and using telemetry circuitry to transmit the second results is significantly more than the judicial exception. The Applicant notes that the combination of judicial exceptions and the additional elements of controlling the telemetry circuitry to transmit the status signals provides an improvement to technology by facilitating adequate data to assess implant procedure success and to improve patient outcome. The examiner respectfully disagrees as the applicant has not identified an additional element, but recited the abstract idea itself. It has been shown that impedance sensing, sensing circuitry to sense EGM signal of a patient, and a signal generator to evaluate PCT are well-known, routine and conventional as shown by the prior art described above and in the previous office actions. In addition the use of telemetry circuitry as a post-solution activity of transmitting data is well-known, routine and conventional as shown by the previously disclosed references. This is not improving the function of a computer or any other technology, but automating a test to identify the performance of an implantable medical device. Therefore, the 101 rejection is being maintained.
Applicant indicates that it is unclear based on comments in the advisory action how disparate thresholds in Gunderson and Seeberger are in any way equivalent to comparing the impedance to a second predetermined impedance threshold different from the first impedance threshold. Therefore the prior art does not disclose or suggest “comparing the impedance to a second predetermined impedance threshold different from the first predetermined impedance threshold” as recited in the independent claim. The examiner respectfully disagrees as during the first test using Gunderson the impedance is being used to determine if the lead is below a previously obtained impedance value (first threshold) indicating a short circuit (e.g. Paragraph [0060] of Gunderson). During the second test sequence the impedance is measured against the certain threshold (second predetermined impedance) to determine that the lead has been connected (e.g. Paragraph [0042] of Seeberger). The first impedance threshold is different by comparing it to a previously obtained impedance and the second has to be lower than a threshold to indicate the lead is connected. The claims as currently written do not provide any insight or in limit the predetermined impedance threshold except to say they are different thresholds, which is apparent from the prior art.
Applicant argues that Seeberger does not disclose or suggest “initiate a second device test sequence different from the first device test sequence comprising at least two of following qualification tests over a second evaluation period”. The Applicant argues the prior art does not disclose or suggest initiating multiple tests and does not suggest a first predetermined period and a second test during a subsequent predetermined period. The examiner respectfully disagrees as Gunderson teaches obtaining the sequence of 1, 2 and 4 obtained over a first period of time and is modified by Seeberger which teaches following a command from a system operator to schedule a system check obtaining a test sequence of 1 and 3 over a second period of time. Therefore, Gunderson performs the first sequence and is modified by Seeberger which receives a command to schedule a second test sequence different from the first test sequence. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. 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).
Claim Objections
Claim 19 is objected to because of the following informalities: “controlling, by the processing circuitry, telemetry circuitry of the IMD and to an external device within a second predetermined time”; specifically “telemetry circuitry of the IMD and to an external device” appears to be missing an action the examiner assumes this should replace “and” with “to transmit”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of using data to indicate the status of an IMD by using at least 2 of: comparing impedance values, EGM data to a threshold, pacing capture threshold, and comparing a physiologic metric to a threshold. This is obtaining data that a surgeon uses after implantation of a device to see if the device is operating properly or if further surgical intervention is necessary and at a different time performing using at least 2 of: comparing impedance values, EGM data to a threshold, pacing capture threshold, and comparing a physiologic metric to a threshold and transmitting the status signal indicating a status. This judicial exception is not integrated into a practical application because the IMD comprising a telemetry circuit, sensing circuitry to sense an electrogram signal, impedance measurement circuitry and a signal generator are pre-solution solutions to obtain data and transmit the data to a user for analysis. The examiner notes the signal generator circuit is not claimed to apply therapy or is being used to deliver cardiac pacing after the diagnostic test, but is claimed to be used for determining a pacing capture threshold (minimal energy to stimulate an action potential from the tissue). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the IMD comprising a telemetry circuit, sensing circuitry to sense an electrogram signal, impedance measurement circuitry and a signal generator are well known routine and conventional. For example Jorgenson et al (US Publications 2002/0120307 discloses an implantable medical device with sensing circuitry 25, signal generator 26 and telemetry circuit 34 and processor 32 in Figure 2 and impedance measurement circuitry 70 in Figure 4 and Paragraph [0054]. In addition, Gunderson (US Publication 2014/0277229) discloses telemetry module 106, sensing circuit 102, impedance monitoring circuit 105, and signal generator 104. Also, Prutchi et al (US Patent 5,531,772) in Figure 1 illustrates the telemetry circuit 22, sensing circuitry 34/36, impedance measurement circuitry (Column 7 lines 31-35), and signal generator 38. The processor is defined in published paragraph [0040] as including a microprocessor, controller, DSP, ASIC, etc. Therefore, the processor is a general-purpose generic computing components and is not considered simply the addition of general purpose computing added to an abstract idea.
Dependent claims 3 and 20 includes an accelerometer (e.g. Jorgenson Paragraph [0052] activity sensor; Gunderson Paragraph [0036]; and Prutchi et al sensor 44 and Column 4 lines 59-62) while the remaining claims further limit the abstract idea itself.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16, and 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 19 require processing circuitry to initiate a first device test sequence comprising at least two of the following qualification tests over a first evaluation period: (1), (2),and/or (4) could be performed. This would not require obtaining a first PCT. Later the claim requires second sequence different from the first sequence comprising determining a second PCT, wherein the second PCT is different from the first PCT. It is unclear if the second sequence is selected, does the claim require the first sequence to determine a first PCT? or can the first sequence can be performed without obtaining a first PCT while enabling the second sequence to obtain a PCT? Would a non-PCT election in the first sequence prevent a PCT from being one of the at least two obtained in the second sequence?
Dependent claims 2-16 and 20 inherit the same deficiencies.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5, 7-13, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al (US Publication 2014/0277229) in view of Seeberger et al (US Publication 2016/0015986).
Referring to Claim 1, Gunderson et al teaches an implantable medical device (IMD) (e.g. Figures 1 and 2, Element 10) configured to be coupled to at least one implantable medical lead (e.g. Figure 1, Elements 14, 16 and 18), wherein the IMD comprises: a telemetry circuitry configured for wireless communication with an external device (e.g. Figure 2, Element 106); sensing circuitry configured to sense an electrogram (EGM) signal of a patient via the implantable medical lead (e.g. Figure 2, Element 102 and Paragraph [0019]); impedance measurement circuitry configured to measure impedance via the implantable medical lead (e.g. Figure 2, Element 105 and Paragraph [0022]); a signal generator configured deliver cardiac pacing via the implantable medical lead (e.g. Figure 2, Element 104); processing circuitry (e.g. Figure 2, Element 112) configured to: within a first predetermined time following an implantation of the IMD in a patient, to initiate a first device test sequence comprising at least two of the following qualification tests over a first evaluation period: (1) detecting an impedance for at least one electrical path that includes at least one electrode of the implantable medical lead, and comparing the impedance to a first predetermined impedance threshold to determine a connection status of the IMD to the at least one electrode (e.g. Paragraph [0060] discloses comparing the impedance to a previous measurement (threshold) to determine a connection status (SC)); (2) comparing, over an EGM test period, at least one EGM event of the patient against a first predetermined EGM event threshold (e.g. Paragraphs [0055-0056] discloses generating patient specific thresholds and using them to detecting an SC event); (4) detecting at least one clinical or patient-specific physiologic metric, and comparing the physiologic metric to a first predetermined physiologic metric threshold (e.g. Paragraph [0036] discloses using a physiological sensor (e.g. accelerometer) for detecting and/or confirming a heart rhythm); control the telemetry circuit to transmit, to the external device within a second predetermined time, a status signal indicating a status of at least one of the diagnostic tests in the first device test sequence (e.g. Paragraph [0056] discloses a patient alert may be generated by the IMD 10 and/or a telemetry alert signal may be transmitted to an external device 150 via wireless telemetry to notify the patient). Gunderson et al does not disclose within a third predetermine time following transmitting of the status signal, initiate a second device test sequence different from the first device test sequence; wherein the second device test sequence comprises at least one of the following diagnostic tests: (1) determining a second PCT, wherein the second PCT is different from the first PCT; (2) comparing, over an EGM test period, at least one EGM event of the patient against a second predetermined EGM event threshold different from the first EGM event threshold; (3) comparing the impedance to a second predetermined impedance threshold, different from the first predetermined impedance threshold; (4) comparing clinical or patient-specific physiologic metrics to a second predetermined physiologic metrics threshold different from the first predetermined physiologic metrics threshold, control the telemetry circuit to transmit, to the external device, a second status signal indicating a status of at least one of the diagnostic tests in the second device test sequence.
Seeberger et al teaches that it is known to use following a command from a system operator to schedule a system check procedure (Paragraphs [0017] and [0081]) to perform a test sequence of: 1) determining a second PCT, wherein the second PCT is different from the first PCT as set forth in Paragraph [0068]; and (3) comparing the impedance to a second predetermined impedance threshold, different from the first predetermined impedance threshold (Paragraph [0042], [0066]) and transmitting the stored data (e.g. Paragraph [0047]) to provide improved diagnostic testing to ensure reliable pacing and the proper operation prior to discharge. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with within a third predetermine time following transmitting of the status signal (following transmitting of the status signal), initiate a second device test sequence different from the first device test sequence of: 1) determining a second PCT, wherein the second PCT is different from the first PCT; and (3) comparing the impedance to a second predetermined impedance threshold, different from the first predetermined impedance threshold and transmitting the stored data as taught by Seeberger et al, since such a modification would provide the predictable results of improved diagnostic testing to ensure reliable pacing and the proper operation prior to discharge.
Referring to Claim 5, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, except wherein the processing circuitry is configured to initiate the first device test sequence prior to an expected discharge time of the patient. Seeberger et al teaches that it is known to use wherein the processor is configured to initiate the first device test sequence prior to an expected discharge time of the patient as set forth in Paragraph [0039] to provide a streamlined process for verifying proper operation and for discharging the patient from a healthcare facility after implantation. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with wherein the processor is configured to initiate the first device test sequence prior to an expected discharge time of the patient as taught by Seeberger et al, since such a modification would provide the predictable results of a streamlined process for verifying proper operation and for discharging the patient from a healthcare facility after implantation.
Referring to Claim 7, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, wherein the processing circuitry is configured to initiate the first device test sequence no later than about 1 hour following the implantation.
Seeberger et al teaches that it is known to use the processor configured to initiate the first device test sequence no later than about 1 hour following the implantation as set forth in Paragraph [0055] (the system check procedure can take place after the procedure to implant the implantable medical device in the patient) and [0059] to provide testing of the device to determine if the one or more aspects of the device are in the desired condition for use on the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the processor configured to initiate the first device test sequence no later than about 1 hour following the implantation as taught by Seeberger et al, since such a modification would provide the predictable results of testing of the device to determine if the one or more aspects of the device are in the desired condition for use on the patient.
Referring to Claim 8, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, except wherein the evaluation period is about 24 hours following the implantation. Seeberger et al teaches that it is known to use the evaluation period is about 24 hours following the implantation as set forth in Paragraphs [0055], [0059], and [0079] to provide testing of the device to determine if the one or more aspects of the device are in the desired configuration or operating properly. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the evaluation period is about 24 hours following the implantation as taught by Seeberger et al, since such a modification would provide the predictable results of testing of the device to determine if the one or more aspects of the device are in the desired configuration or operating properly.
Referring to Claim 9, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, wherein the first device test sequence includes diagnostic tests (1)-(2) (e.g. Paragraphs [0055-0056] and [0060] and Seeberger et al [0042], [0066-0067]).
Referring to Claim 10, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, wherein the first device test sequence includes diagnostic tests (1)-(4) (e.g. Paragraphs [0036], [0055-0056], [0060] and Seeberger et al as combined in the 103 above with Paragraph [0068] ).
Referring to Claim 11, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, wherein the first device test sequence includes diagnostic test (4) (e.g. Paragraph [0036]).
Referring to Claim 12, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, wherein the second predetermined time is about every 2 hours following completion of the device test sequence. Seeberger et al teaches that it is known to use the second predetermined time is about every 2 hours following completion of the device test sequence as set forth in Paragraph [0064] (discloses the test initiated at 11:30 AM and the results are ready for the operator at 12:00pm to provide the data necessary for the operator to make a determination on the patient’s status. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the second predetermined time is about every 2 hours following completion of the device test sequence as taught by Seeberger et al, since such a modification would provide the predictable results of providing the data necessary for the operator to make a determination on the patient’s status.
Referring to Claim 13, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, except wherein the status signal comprises at least one of an aggregate or a summary of a status of at least two of the diagnostic tests (1)-(4). Seeberger et al teaches that it is known to use the status signal comprises at least one of an aggregate or a summary of a status of at least two of the diagnostic tests (1)-(4) as set forth in Figure 7 and Paragraphs [0081-0083] to provide a summary of the post procedural system check to enable determination by the user if the one or more aspects of the device are in the desired configuration or operating properly. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the status signal comprises at least one of an aggregate or a summary of a status of at least two of the diagnostic tests (1)-(4) as taught by Seeberger et al, since such a modification would provide the predictable results of a summary of the post procedural system check to enable determination by the user if the one or more aspects of the device are in the desired configuration or operating properly.
Referring to Claim 19, Gunderson et al teaches a method, comprising: initiating, by processing circuitry an implantable medical device (IMD) (e.g. Figures 1 and 2, Element 10), within a first predetermined time following an implantation of the IMD in a patient, a first device test sequence in which the IMD performs at least two of the following qualification tests over a first evaluation period: (1) detecting an impedance for at least one electrical path that includes at least one electrode, and comparing the impedance to a first predetermined impedance threshold to determine a connection status of the IMD to the at least one electrode (e.g. Paragraph [0060] discloses comparing the impedance to a previous measurement (threshold) to determine a connection status (SC)); (2) comparing, over an electrogram (EGM) test period, at least one EGM event of the patient against a first predetermined EGM event threshold (e.g. Paragraphs [0055-0056] discloses generating patient specific thresholds and using them to detecting an SC event); (4) detecting at least one clinical or patient-specific physiologic metric, and comparing the physiologic metric to a first predetermined physiologic metric threshold (e.g. Paragraph [0036] discloses using a physiological sensor (e.g. accelerometer) for detecting and/or confirming a heart rhythm); controlling, by the processing circuitry, telemetry circuitry of the IMD and to an external device within a second predetermined time, a status signal indicating a status of at least one of the diagnostic tests in the first device test sequence (e.g. Paragraph [0056] discloses a patient alert may be generated by the IMD 10 and/or a telemetry alert signal may be transmitted to an external device 150 via wireless telemetry to notify the patient). Gunderson et al does not disclose within a third predetermine time following transmitting of the status signal, initiate a second device test sequence different from the first device test sequence; wherein the second device test sequence comprises at least one of the following diagnostic tests: (1) determining a second PCT, wherein the second PCT is different from the first PCT; (2) comparing, over an EGM test period, at least one EGM event of the patient against a second predetermined EGM event threshold different from the first EGM event threshold; (3) comparing the impedance to a second predetermined impedance threshold, different from the first predetermined impedance threshold; (4) comparing clinical or patient-specific physiologic metrics to a second predetermined physiologic metrics threshold different from the first predetermined physiologic metrics threshold; and controlling, by the processor circuitry to transmit, to the external device, a second status signal indicating a status of at least one of the diagnostic tests in the second device test sequence.
Seeberger et al teaches that it is known to use following a command from a system operator to schedule a system check procedure (Paragraphs [0017] and [0081]) to perform a test sequence of: 1) determining a second PCT, wherein the second PCT is different from the first PCT as set forth in Paragraph [0068]; and (3) comparing the impedance to a second predetermined impedance threshold, different from the first predetermined impedance threshold (Paragraph [0042], [0066]) and transmitting the stored data (e.g. Paragraph [0047]) to provide improved diagnostic testing to ensure reliable pacing and the proper operation prior to discharge. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Gunderson et al, with within a third predetermine time following transmitting of the status signal (following transmitting of the status signal), initiate a second device test sequence different from the first device test sequence of: 1) determining a second PCT, wherein the second PCT is different from the first PCT; and (3) comparing the impedance to a second predetermined impedance threshold, different from the first predetermined impedance threshold and transmitting the stored data as taught by Seeberger et al, since such a modification would provide the predictable results of improved diagnostic testing to ensure reliable pacing and the proper operation prior to discharge.
Claim(s) 2, 3 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al (US Publication 2014/0277229) in view of Seeberger et al (US Publication 2016/0015986) as applied above, and further in view of Averina et al (US Publication 2019/0216404).
Referring to Claims 2, 3 and 20, Gunderson et al in view of Seeberger et al teaches the claimed invention, further comprising an accelerometer, wherein the processing circuitry is configured to: determine at least one of body posture or ambulation; determine a discharge status, based on the at least one of body posture or ambulation, of the patient; initiate the device test sequence after obtaining the discharge status.
Averina et al teaches that it is known to use ambulatory devices, including implantable medical devices (Paragraph [0036]) with accelerometer (Paragraph [0037] and [0073]) to monitor a patient’s (ambulating) activity or posture (e.g. Paragraphs [0058] and [0065]) to provide a discharge readiness assessment (e.g. Paragraphs [0047] and [0075]) to provide determination the patient is stressed by changing positions and/or is ambulating to determine the likelihood of deleterious medical condition or successful discharge. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Gunderson et al, with further comprising an accelerometer, wherein the processor is configured to: determine at least one of body posture or ambulation; determine a discharge status, based on the at least one of body posture or ambulation, of the patient; initiate the device test sequence after obtaining the discharge status as taught by Averina et al, since such a modification would provide the predictable results of determination the patient is stressed by changing positions and/or is ambulating to determine the likelihood of deleterious medical condition or successful discharge.
Claim(s) 2, 4 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al (US Publication 2014/0277229) in view of Seeberger et al (US Publication 2016/0015986) as applied above, and further in view of Mullen et al (US Publication 2019/0006030).
Referring to Claims 2, 4 and 20, Gunderson et al in view of Seeberger et al teaches the claimed invention, wherein the processing circuitry is configured to: determine a location of the patient; determine a discharge status, based on the location of the patient, of the patient; initiate the device test sequence after obtaining the discharge status. Mullin et al teaches that it is known to use a patient’s determined location as a factor of readiness for discharge the processor will analyze several different data points to automatically determine when the patient is ready for discharge as set forth in Paragraphs [0030-0032] to provide improving patient readiness by determining that the patient is in a location that indicates surgery is complete and can be evaluated for discharge. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Gunderson et al, with determine a location of the patient; determine a discharge status, based on the location of the patient, of the patient; initiate the device test sequence after obtaining the discharge status as taught by Mullin et al, since such a modification would provide the predictable results of improving patient readiness by determining that the patient is in a location that indicates surgery is complete and can be evaluated for discharge.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al (US Publication 2014/0277229) in view of Seeberger et al (US Publication 2016/0015986) as applied above, and further in view of Ternes et al (US Publication 2018/0153460).
Referring to Claim 6, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, except wherein the processing circuitry is configured to control the telemetry circuit to transmit the status signal at least once every 3 hours following the implantation.
Ternes et al teaches that it is known to use transmitting the data in batch mode such as every one hour as set forth in Paragraphs [0055] and [0084] to provide reduced power consumption and efficiently use the communication bandwidth. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the processing circuitry is configured to control the telemetry circuit to transmit the status signal at least once every 3 hours following the implantation as taught by Seeberger et al, since such a modification would provide the predictable results of reduced power consumption and efficiently use the communication bandwidth.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al (US Publication 2014/0277229) in view of Seeberger et al (US Publication 2016/0015986) as applied above, and further in view of Goetz et al (US Publication 2011/0307032).
Referring to Claim 14, Gunderson et al in view of Seeberger et al teaches the IMD of claim 13, except wherein the status signal is chosen from complete/pass, complete/fail, and incomplete.
Goetz et al teaches that it is known to use status results of “ok/pass” or failing, or could not perform test as set forth in Paragraph [0226] and Figure 28 to provide allowing a user to quickly and easily understand a result of the structure being tested. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the status signal is chosen from complete/pass, complete/fail, and incomplete as taught by Goetz et al, since such a modification would provide the predictable results of allowing a user to quickly and easily understand a result of the structure being tested.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al (US Publication 2014/0277229) in view of Seeberger et al (US Publication 2016/0015986) as applied above, and further in view of Zhang et al (US Publication 2011/0009760).
Referring to Claims 15-16, Gunderson et al in view of Seeberger et al teaches the IMD of claim 1, except wherein the processing circuitry is configured to, within a third predetermined time (less than 24 hours) following the transmission of the status signal, control the telemetry circuit to transmit an implant confirmation signal to the external device.
Zhang et al teaches that it is known to use collecting physiological data within a window of about 1 day following discharge from the hospital (Paragraph [0060]) and communicating the readmission alert to a clinician as set forth in Figure 2, Element 347 to provide early detection of deleterious change in the physiological data. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Gunderson et al, with the processing circuitry is configured to, within a third predetermined time (less than 24 hours) following the transmission of the status signal, transmit an implant confirmation signal to the external device as taught by Zhang et al, since such a modification would provide the predictable results of early detection of deleterious change in the physiological data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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