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 .
Amendment
This action is in response to the Amendment filed on 4/20/2026.
Claims 1-19 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1-19 have been considered but are moot in view of the new grounds of rejection as necessitated by the amendments.
CLAIM REJECTIONS UNDER 35 USC 101
The examiner respectfully disagrees with applicant’s arguments regarding the rejections under 35U.S.C. 101 for the following reasons.
The signal acquisition module that acquires cardiac signals indicative of cardiac operation, pacing impulses emitted by the pacing device, evoked signals emitted from a patient's heart in response to the pacing impulses, and noise signals are considered as a pre-solution activity of data collection. the claims are directed to an apparatus that monitors the cardiac pacing device and do not positively recite the cardiac pacing device as part of the claimed invention. Therefore, the signal acquisition system, that comprises circuitry including epicardial and endocardial leads is pre-solution activity of collecting data signals.
The abstract idea lies in the steps (ii-iv) of independent claims 1,12 and 19.
The steps perform by the processor that include establishing base level operation of the heart and pacing device is basically obtaining data and determining baseline values of the heart and the pacing device which is also pre-solution activity of obtaining data and to determine baseline operations.
The step of providing an alert if there is any oversensing or undersensing based on steps ii to iv is considered as post-solution activity.
Applicant argues that the claimed apparatus provides automated monitoring that can detect oversensing and under sensing without requiring constant attention from trained cardiac specialists and is thus an improvement to the existing technology of cardiac pacing monitoring.
However, the arguments are not persuasive as the improvement lies in the abstract idea and not the device itself.
The claims as recited just require a signal acquisition circuitry that are adapted to acquire data via epicardial or endocardial leads that are used to obtain data regarding the heart and the pacing device and any noise signals and a processor that is used to analyze the obtained signals as shown in Fig. 4 of the originally filed specifications. The claims as recited do not positively recite the epicardial or endocardial leads as part of the claimed TPMS monitoring apparatus, the TPMS is “capable of” being connected to epicardial or endocardial leads and is located externally of the patient’s body.
These are generic components that are well known as shown in Von Bergen et al (U.S. Patent Application Publication Number: US 2018/0036542 A1, hereinafter “Von Bergen”) in Figs.1-4. Thus the claims as recited do not recite any additional elements that integrate the judicial exception into a practical application and that amount to significantly more than the judicial exception. Therefore the rejection is maintained.
The examiner suggests amending the claim to recite that the stimulation parameters of the temporary cardiac pacing device are altered to provide therapy in response to the processor raising the alarm in order to overcome the rejection under 35 U.S.C. 101.
Claims 10 and 15
In view of the amendments, the rejection under 35 U.S.C. 101 have been withdrawn.
CLAIM REJECTIONS - 35 USC 102 - Hecker (US9610020B1).
Independent claim 1 as amended recites: "a signal acquisition module adapted to acquire cardiac signals indicative of cardiac operation, pacing impulses emitted by the pacing device, evoked signals emitted from a patient's heart in response to the pacing impulses, and any noise signals." The claim further recites "a processor adapted to receive from the signal acquisition module" the signals for analysis. These limitations require that the external monitoring apparatus itself comprises a signal acquisition module that directly acquires the recited signals, and that the processor receives signals from that signal acquisition module.
Applicant’s arguments with respect to Hecker’s teachings have been considered and in view of the amendments and the rejection is now withdrawn. However, upon further search and consideration, the claims are rejected as discussed in the current office action below.
CLAIM REJECTIONS - 35 USC 103
In view of the amendments, the claims are now rejected as discussed in the current office action below.
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 1-17 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1, 12 and 19 recite a temporary pacing management and safety TPMS monitoring apparatus and methods of monitoring pacing of a patient's heart by use of the TPMS apparatus adapted to monitor a temporary cardiac pacing device. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to an apparatus and 12 and 19 are directed to methods, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 12 and 19 recite the steps comprising:
“ii. receive instantaneous values of quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses
iii. compare the instantaneous values against the values in the data store to establish differences therebetween;
iv. analyze any difference(s) at step iii above in terms of its/their quality, size and timing and, in the event a noise signal occurs or a noise signal occurs and no cardiac signal or evoked signal is received, to follow at least one of:
an oversensing algorithm when a noise signal is received to determine whether or not there has been any oversensing and an undersensing algorithm to determine whether or not there has been any undersensing; and
v. raise an alarm if it determines that there has been any oversensing and/or any undersensing”.
The steps: “i. establish a base level operation of the heart and pacing device and to store the associated quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses in the data store; and ii. receive instantaneous values of quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses” are considered as the pre-solution activity of collecting data from the temporary pacing device.
Steps iii-v are the abstract idea that can be performed by a clinician by reviewing the collected data that has been acquired and received.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 12, and 19 recite an abstract idea of a mental process.
The limitations as drafted in the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic cardiac pacing device, a memory and a processor, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example a clinician can compare the instantaneous values against previous data values on a strip chart or manually to establish differences therebetween, analyze any differences by viewing the data in terms of its/their quality, size and timing and, in the event a noise signal occurs or a noise signal occurs and no cardiac signal or evoked signal is received by comparing it to thresholds, determine there is an oversensing any undersensing by comparing to established thresholds; and raise an alarm by flagging the data .
Further, dependent Claims 2-11 and 13-17 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 12 and 19 recite the additional elements of “epicardial or endocardial leads”, “processor”, “memory”, “signal acquisition module” and the “cardiac pacing device” (which is not positively claimed as part of the claimed TPMS monitoring apparatus). However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, the “epicadial or endocardial leads”, “processor”, “memory”, “signal acquisition module” and the “cardiac pacing device” (which is not positively claimed as part of the claimed external monitoring apparatus) are being interpreted as generic components to perform the steps of data collection and analysis and amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Von Bergen et al (U.S. Patent Application Publication Number: US 2018/0036542 A1, hereinafter “Von Bergen”), Spotnitz et al (U.S. Patent Application Publication Number: US 2011/0264159 A1, hereinafter “Spotnitz”) are teachings of a temporary external monitoring device for a temporary cardiac pacing device.
and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
It is suggested that the claims be amended to include limitations from claim 18 that recite that the processor is configured to further alter the parameters of the external monitoring system or of the temporary cardiac pacing device in response to the processor raising the alarm in order to overcome the rejection under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 7 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Von Bergen et al (U.S. Patent Application Publication Number: US 2018/0036542 A1, hereinafter “Von Bergen”) in view of Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”- PREVIOUSLY CITED).
Regarding claims 1, 12, 14 and 19, Von Bergen teaches a temporary pacing management and safety, TPMS, monitoring apparatus (i.e. telemetry monitoring system e.g. 24 Fig.1, [0036]) adapted to monitor a temporary cardiac pacing device (i.e. pulse generator e.g. 32 Fig1,[0036]) that is located externally to a patient's body (e.g. 12 Fig.1, [0036]), the TMPS monitoring apparatus being connectable to the patient's heart via epicardial or endocardial leads (i.e. epicardial pacing wires e.g. 20a, 20b Fig.1,2,[0038]-[0040]) located externally of the patient's body and comprising:
signal acquisition circuitry adapted to acquire, via electrical connections with the heart and the pacing device, cardiac signals indicative of cardiac operation, pacing impulses emitted by the pacing device, evoked signals emitted from a patient's heart in response to the pacing impulses, and any noise signals, the electrical connection with the heart comprising the epicardial or endocardial leads (e.g. [0041], [0044],[0057]); and
a processor (e.g. 0057]) adapted to receive from the signal acquisition circuitry and to analyze the cardiac and evoked signals, the pacing impulses and the any noise signals; and a data store (e.g. 24 is a desktop computing device processor that obtains signals and displays them and therefore has data storage for display).
Von Bergen does not specifically teach the processor is adapted to:
i. establish a base level operation of the heart and pacing device and to store associated quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses in the data store; ii. receive instantaneous values of quality, size and/or timing values of the cardiac and evoked signals and the pacing; iii. compare the instantaneous values against the values in the data store to establish differences therebetween; iv. analyse any difference(s) at step iii above in terms of its/their quality, size and timing and follow at least one of: an oversensing algorithm to determine whether or not there has been any oversensing, and an undersensing algorithm to determine whether or not there has been any undersensing; and v. raise an alarm if it determines that there has been any oversensing and/or any undersensing.
Hecker teaches a processor adapted to receive data from a signal acquisition module and to analyze the cardiac and evoked signals, the pacing impulses and any noise signals; and a data store (e.g. Col. 6 lines 63- col.7 line 8, Col. 7 lines 29-40: Hecker teaches that the data collected by the pacemaker IMD 502 is transmitted to the external device 504 which then analyzes the collected cardiac and evoked signals, pacing impulses and noise signals to determine if there is any oversensing or undersensing).
Hecker further teaches that the processor is configured to analyze the collected data by determining a baseline and comparing the instantaneous values against the values in the data store to establish differences therebetween and analyze any differences above in terms of its/their quality, size and timing (e.g. col. 2 lines 64-col. 3 lines 7: a baseline of heart activity may be determined utilizing the data and may be compared to current heart activity, such that a problem may be automatically identified based on the comparison) and to follow an oversensing and undersensing algorithm to determine whether or not there has been any oversensing and there has been any undersensing (e.g. Abstract, Figs.2,3 Fig.4A) and raise an alarm if it determines that there has been any oversensing and any undersensing (e.g. 307 Fig.3, Col. 5 lines 3-14): user may or may not choose to confirm the changes that may be instituted and therefore the user is provided with a notification about the oversensing or undersensing). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Von Bergen to include the signal processing for detecting oversensing and undersensing and data storage as taught by Hecker in order to provide the predictable results of providing the clinician additional tools for diagnosis.
Regarding claim 2, Von Bergen in view of Hecker teaches the claimed invention as discussed above except for the undersensing algorithm comprising determining that there has been the undersensing if the processor receives a pacing signal within an undersensing time window after it receives the cardiac signal.
Hecker further teaches that the undersensing algorithm comprises determining that there has been the undersensing if the processor receives a pacing signal within an undersensing time window after it receives the cardiac signal. (e.g. Fig. 4A, col. 5 line 19-46). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Von Borgen in view of Hecker to include the details of the undersensing algorithm as taught by Hecker in order to provide the predictable results of providing an accurate diagnosis.
Regarding claim 7, Von Bergen in view of Hecker teaches the claimed invention as discussed above Von Bergen teaches a display (e.g. [0010], [0016], [0044]) and therefore they teach a visual and or audible alarm to alert an operator/medic/nurse that the functioning of the patient's heart and/or the pacing device is incorrect.
Regarding claim 8, Von Bergen in view of Hecker teaches the claimed invention as discussed above except for communications circuitry adapted to communicate to/from a user interface which is remote from the apparatus.
Hecker further teaches a communications module adapted to communicate to/from a user interface which is remote from the apparatus (e.g. Fig. 5 Col. 6 lines 63- Col. 7 line 40). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Von Bergen in view of Hecker to comprise communications circuitry adapted to communicate to/from a user interface which is remote from the apparatus via one or more networks as taught by Hecker in order to provide the predictable results of allowing for additional support from other remotely located clinicians.
Regarding claim 9, Von Bergen in view of Hecker teaches the claimed invention as discussed above and Von Bergen teaches electrical connections which is configured to be connected to the patient's heart and the temporary cardiac pacing device by electrical connections such that the patient's heart, the apparatus and the pacing device are connected in an inline arrangement (e.g. Fig.2-4, [0045]).
Regarding claim 10, Von Bergen in view of Hecker teaches the claimed invention as discussed above and Von Bergen teaches electrical connections with the heart and with the pacing device, wherein the electrical connections to the heart are placed so as to provide pacing signals to one of or to both of the atrial and ventricular chambers (e.g. [0017]).
Regarding claim 11, Von Bergen in view of Hecker teaches the claimed invention as discussed above and Von Bergen teaches the processor is adapted to integrate and utilize data from additional biomedical sensors (e.g. [0044]).
Regarding claim 13, Von Bergen in view of Hecker teaches the claimed invention as discussed above except for following the oversensing algorithm comprises determining that there has been oversensing if: the processor detects a noise signal; and the processor either receives no cardiac signal within an oversensing time window following a pacing signal, or receives a plurality of cardiac signals at a rate below a pacing base rate.
Hecker further teaches the oversensing algorithm comprises determining that there has been oversensing if: the processor detects a noise signal; and the processor either receives no cardiac signal within an oversensing time window following a pacing signal, or receives a plurality of cardiac signals at a rate below a pacing base rate (e.g. Fig.2, Col. 4 lines 6-13, Fig. 4A, B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Von Bergen in view of Hecker to determine oversensing as further taught by Hecker in order to provide the predictable results of providing the clinician a more effective tool for diagnosis.
Regarding claim 15, Von Borgen in view of Hecker teaches the claimed invention as discussed above and Von Berger teaches the temporary cardiac pacing device (e.g. 32 Fig.1) from which the signal acquisition module circuitry acquires pacing signals is adapted to be located externally to a patient's body (e.g.12 Fig.1).
Regarding claim 16, Von Borgen in view of Hecker teaches the claimed invention as discussed above and Von Berger teaches that the external monitoring apparatus (e.g. 24 Fig.1) is a separate device to the temporary cardiac pacing device (e.g. 32 Fig.1).
Regarding claim 17, Von Borgen in view of Hecker teaches the claimed invention as discussed above except for monitoring the external monitoring apparatus during an initial, set up stage to ensure that the base levels established by the processor are correct and do not correspond to any inappropriate functioning of the patient's heart or the temporary cardiac pacing device
Hecker teaches monitoring the external monitoring apparatus during an initial, set up stage to ensure that the base levels established by the processor are correct and do not correspond to any inappropriate functioning of the patient's heart or the temporary cardiac pacing device (e.g. Col. 2 line 67- col. 3 line 9: a baseline of heart activity may be determined, user-configured to cover a certain timeframe … if it is found that non-physiological activity is identified (which did not exist with respect to the baseline), such may be an indication that a sensing problem exists). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Von Borgen in view of Hecker to perform procedure by monitoring the external monitoring apparatus during an initial, set up stage to ensure that the base levels established by the processor are correct and do not correspond to any inappropriate functioning of the patient's heart or the temporary cardiac pacing device as taught by Hecker in order to provide the predictable results of reducing errors.
Regarding claim 18, Von Borgen in view of Hecker teaches the claimed invention as discussed above except for further altering parameters of the external monitoring apparatus or of the temporary cardiac pacing device in response to the processor raising the alarm.
Hecker teaches further altering parameters of the external monitoring apparatus or of the temporary cardiac pacing device in response to the processor raising the alarm (e.g. e.g. 304, 307 Fig.3, Col. 5 lines 3-14). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Von Borgen in view of Hecker and alter the parameters of the external monitoring apparatus or of the temporary cardiac pacing device in response to the processor raising the alarms taught by Hecker in order to provide the predictable results of addressing and correcting any problems determined during the monitoring.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Von Bergen et al (U.S. Patent Application Publication Number: US 2018/0036542 A1, hereinafter “Von Bergen”) in view of Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”- PREVIOUSLY CITED) and further in view of Ferek-Petric (U.S. Patent Number: US 5076272 hereinafter “Ferek-Petric” -PREVIOUSLY CITED).
Regarding claim 3, Von Borgen in view of Hecker teaches the claimed invention as discussed above except for the processor being adapted to follow a loss of capture algorithm to establish whether there has been a loss of capture and to raise an alarm if there is determined to have been a loss of capture, wherein following the loss-of-capture algorithm comprises determining that there has been a loss of capture if the processor receives no cardiac signal within an evoked response time window after receiving a pacing impulse.
In a similar field of endeavor, Ferek- Petric teaches an implantable cardiac pacemaker comprising a processor that is adapted to follow a loss of capture algorithm to establish whether there has been a loss of capture and to raise an alarm if there is determined to have been a loss of capture, wherein following the loss-of-capture algorithm comprises determining that there has been a loss of capture if the processor receives no cardiac signal within an evoked response time window after receiving a pacing impulse. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the processor in the teachings of Von Borgen in view of Hecker to include the loss of capture algorithm to determine if the processor receives no cardiac signal within an evoked response time window after receiving a pacing impulse as taught Ferek-Petric in order to provide the predictable results of improving monitoring of the implantable pacing device.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Von Bergen et al (U.S. Patent Application Publication Number: US 2018/0036542 A1, hereinafter “Von Bergen”) in view of Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”- PREVIOUSLY CITED) and further in view of Bulkes et al (U.S. Patent Application Publication Number: US 2008/0039904 A1, hereinafter “Bulkes”- PREVIOUSLY CITED).
Regarding claim 4, Von Borgen in view of Hecker teaches the claimed invention as discussed above except for the processor being adapted to follow an arrhythmia algorithm to sense arrhythmia by detecting a sudden change in cardiac rhythm, and to raise an alarm when the arrhythmia is sensed.
In a similar field of endeavor, Bulkes teaches a system (e.g. Fig. 3, 6 [0268], [0270])) that comprises an external monitoring device (i.e. data processing device 230 Fig. 6) that provides an alarm ( e.g. [0305]-[0309]) when a sudden change in cardiac rhythm is detected (e.g. [0308], [0309]: if the data indicates either a serious condition of the patient, for example, absence of heartbeat for a pre-specified amount of time). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Von Borgen in view of Hecker so that the processor is adapted to sense arrhythmia by detecting a sudden change in cardiac rhythm, and to raise an alarm when the arrhythmia is sensed in order to provide the predictable results of providing a more efficient monitoring device for alerting the patient and clinician.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Von Bergen et al (U.S. Patent Application Publication Number: US 2018/0036542 A1, hereinafter “Von Bergen”) in view of Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”- PREVIOUSLY CITED) and further in view of Helfenbein et al (U.S. Patent Application Publication Number: US 2011/0092838 hereinafter “Helfenbein”- PREVIOUSLY CITED).
Regarding claim 5, Von Borgen in view of Hecker teaches the claimed invention as discussed above except for the processor being adapted to respond to an operator input request to carry out QT analysis or rhythm analysis and to follow respective algorithms to perform a requested analysis.
In a similar field of endeavor, Helfenbein teaches ECG monitoring system (e.g. [0029]) that continuously monitors a patient's ECG waveform and periodically identifies the patient's QT interval as well as perform rhythm analysis (e.g. [0028]: beat classifications are used to determine the heart rhythm) based on the user selected settings and provides alarms (e.g. abstract, [0039]- [0041]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Von Borgen in view of Hecker to respond to an operator input request to carry out QT analysis or rhythm analysis and to follow respective algorithms to perform a requested analysis as taught by Helfenbein in order to provide the predictable results of improving the monitoring of the patient.
Regarding claim 6, Von Borgen in view of Hecker and Helfenbein teaches the claimed invention as discussed above except for the data store being adapted to contain causal data and values relating to the causes of cardiac arrythmia and related pacing device settings appropriate for each cause, the processor being adapted when requested to perform the rhythm analysis to compare instantaneous values with those in the data store, identify the cause which best matches the causal data and values in the data store and to display related pacing device settings.
Hecker further teaches that the data store is adapted to contain causal data and values relating to the causes of cardiac arrythmia and related pacing device settings appropriate for each cause, the processor being adapted when requested to perform the rhythm analysis to compare instantaneous values with those in the data store, identify the cause which best matches the causal data and values in the data store and to display related pacing device settings (e.g. col. 7 lines 56-67: display to a user through a graphical interface (such as on the display of external device 504) the current non-ideal programmed settings and the suggested ideal settings while graphically depicting both parameter sets as an overlay on either the stored or frozen real-time electrogram where a sensing anomaly has occurred). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Von Bergen in view of Hecker and Helfenbein so that the data store is adapted to contain causal data and values relating to the causes of cardiac arrythmia and related pacing device settings appropriate for each cause and the processor being adapted when requested to perform the rhythm analysis to compare instantaneous values with those in the data store, identify the cause which best matches the causal data and values in the data store and to display related pacing device settings as taught by Hecker in order to provide the predictable results of providing the clinician with additional support in diagnosis and a more effective monitoring and pacing device.
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 MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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