DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The amendment to the specification and claims are sufficient to overcome the previous objections.
Applicant's arguments filed 5/30/2025 have been fully considered but they are not persuasive. The Applicant argues, under Step 2A prong 1, claim 1 recites a medical device that includes sensing circuitry, a signal generator, other circuitries, and is configured to initiate a first device test sequence and a second device test sequence and transmit status signals to an external device and thus is not an abstract idea. The examiner notes that the processing steps are at least 2 of comparing impedance values, EGM data toa threshold, pacing capture threshold and comparing a physiological metric to a threshold. Based on Step 2A Prong 1, the claim recites a judicial exception, an abstract idea. The recitation of the additional elements is evaluated in the following steps and the presence does not exclude the claim from further analysis.
Under Step 2A prong two and step 2B the Applicant has identified the initiating first and second device test sequences, which is part of the abstract idea and not an additional element; and transmitting, via the telemetry circuit. The examiner respectfully disagrees that a telemetry circuit used for transmitting the status signal is sufficient to integrate the judicial exception into a practical application or recite significantly more than the judicial exception. The examiner notes that the telemetry circuit is part of an extra-solution activity of transmitting data and is well known, routine and conventional. The examiner notes Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) which the court has found is a mental process when the claim is directed to collecting information, analyzing it, and displaying certain results of the collection and analysis. Therefore, the arguments are not persuasive and the 101 rejection remains.
Regarding the 112(d) rejection the Applicant claim 2 recites “initiate the first device sequence based on the discharge status” and thus positively recites performing the first test device sequence and does not raise the possibility that the test device sequence is not run. The examiner respectfully disagrees as the first test sequence is run based (emphasis added) the discharge status. This means that the discharge status has to have a particular result for it to run. As opposed to saying “initiate the first device sequence after obtaining the discharge status”, which would always initiate the first device sequence after determining a discharge status. Since the initiating of a first discharge status is contingent on the discharge status, there is the potential for all the limitation of claim 1 not to be performed.
Regarding Gunderson in view of Seeberger, the Applicant argues Seeberger does not disclose initiating a second device test sequence different from the first device test sequence comprising at least two of the following test qualification tests over a second evaluation period. The examiner respectfully disagrees as Seeberger teaches control circuitry to execute a post-procedural system check procedure after the expiration of a preselected first time period. Paragraph [0081] allows the user to specify post-procedural system check procedures as a number of hours from a particular trigger. Regarding the second test sequence different form the first the examiner notes that Gunderson discloses using a predetermine number of impedance (step 1); EGM (step 2); and physiological metric (step 4); while the second test sequence as taught by Seeberger teaches PCT (step 1 of the second steps); EGM (step 2); and impedance (step 3). The Applicant argues that the second test sequence steps 2 and 3 are not using comparing the data to a second predetermine (EGM or impedance) event threshold different from the first (EGM or impedance) event threshold. The examiner notes that in Gunderson the impedance is compared to a previous impedance measurement. Gunderson is looking for a short circuit response to a very low impedance (e.g. Paragraph [0026]), while in Seeberger the impedance is compared to see if it is below a certain threshold value which is different from a previous impedance measurement. Therefore, the first test performs impedance, EGM and physiological metric; and the second test performs steps PCT, and impedance (using a different threshold form the first). The examiner notes these two are different from the first test sequence. Therefore, the arguments against Gunderson in view of Seeberger are not persuasive.
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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 20 place conditions on when the device test sequence is performed. Claims 1 and 19 require the device test performance to be run within a first predetermined time following implantation, but claims 2 and 20 require initiating the device test sequence based on the discharge status; therefore, the test sequence might not be run or is run after the first predetermined time. Therefore, claims 2 and 20 are broadening the claim by raising the possibility the device test sequence not run within the first predetermined time. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 3 and 4 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, 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); transmit, via the telemetry circuitry, 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, wherein the processor is configured 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 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 an 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); transmitting, by the IMD, 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, wherein the processor is configured 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 based on 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 based on 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 based on 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 based on 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 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 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, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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