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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02OCT2024 & 06NOV2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Implantable device 12 is stated on page 7 line 19 of the specification. Other mentions of part 12 refer to pulse generator 12. This needs correction to have consistent terminology.
Device 30 is stated on page 8 lines 5 & 14 of the specification. Other mentions of part 30 refer to Programmer 30. This needs correction to have consistent terminology.
Rhythm analysis 150 and therapy 150 are stated on page 11 lines 15-17 of the specification. Separate items should not share part numbers.
Part 410 from Figure 5 of the drawings is not found in the specification.
Part 460 from Figure 6 of the drawings is not found in the specification.
Part 486 from Figure 7 of the drawings is not found in the specification.
Part 488 from Figure 7 of the drawings is not found in the specification.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "200" and "202" have both been used to designate device ID in Figure 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Part 220 in Figure 3 appears to be pointing only at overdetection when the specification describes 220 as being the entire table . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-7 & 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 6 & 17:
Claim limitation “customer service center” is described in the Specification on Page 16 Lines 1-3 stating “customer service center 350 having a counter analysis processor 320 and an expert 330, which may be a human or an automated system.”, but no specific device is named which can be considered a customer service center. The customer service center as claimed is undefined in the specification as the mentions of a customer service center does not provide adequate structure or processing steps which would define the component in a tangible or meaningful way. Since the specification lacks a physical structure for the customer service center, one of ordinary skill in the art could be led to consider the customer service center as a user interface, data hub, processor, etc. Since it is unclear what the customer service center is meant to be claimed as, and the specification lacks the written support, the claim lacks a written description. See MPEP §2163.
Claim 7 is further rejected for depending upon rejected claim 6.
Claim 18 is further rejected for depending upon rejected claim 17.
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 4-7 & 17-18 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.
Regarding claim 4:
Claim 4 recites “also including a communication circuit which also performs the communication step” in Lines 2-4. It is unclear if this is introducing a new communication circuit, or if this is meant to be the same communication circuit as recited In claim 1 since the communication circuit in claim 1 is not claimed as a part of the IMD which is being monitored, but in wireless communication with the IMD. For the purpose of examination, the examiner is interpreting this as the same communication circuit. Correction is required.
Claim 5 is additionally rejected for depending upon the rejected claim 4.
Regarding Claims 6 & 17:
The claims recite “customer service center” in Lines 2 & 2-3 respectively. It is unclear what a customer service center is meant to represent as this can range from a user interface, a hub, or additional programming. For the purpose of examination, the examiner is interpreting this as being a user interface. Clarification is required.
Claim 7 is further rejected for depending upon rejected claim 6.
Claim 18 is further rejected for depending upon rejected claim 17.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claims 1 & 19 are directed to a method and thus meets the step 1 requirements.
Claim 13 is directed to a system and thus meets the step 1 requirements.
Step 2A – Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Regarding claims 1, 13, & 19 the following step is an abstract idea: “analyzing the RM session data to determine sensing quality for the IMD, wherein: the RM session data includes data for a plurality of counters present in the IMD”, “monitoring operation of a cardiac implantable medical device (IMD)”, “maintaining a plurality of counters for events that the IMD identifies”, “analyzing data in the plurality of counters;”, “determining from the data in the plurality of counters that the IMD has experienced a drop in signal quality”, and “modifying an operating parameter of the IMD.”; which are mental processes when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions.
In this case, a human could monitor and analyze sensing quality in data to determine signal quality by observing the data acquired for changes in trends, tracked by counting events that occur. This can be done using a pen and paper by a human, and amounts to no more than tracking data trends of a plurality of data sets and noting when a change is needed.
Step 2A – Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Regarding claims 1, 13, and 19, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
“an implantable medical device”, “a communication circuit”, and “a processor” are recited at a
high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
“RM session”, “RM session data”, “sensing quality”, “data”, “plurality of counters”, “drop in signal quality”, and “alert” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
“Operating a communication circuit” - mere instructions to apply the exception in a generic way
see MPEP §2106.04(d)(2)(a).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The following claim elements do not add any meaningful limitation to the abstract idea:
“an implantable medical device”, “a communication circuit”, and “a processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
“RM session”, “RM session data”, “sensing quality”, “data”, “plurality of counters”, “drop in signal quality”, and “alert” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
“operating a communication circuit” - mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a).
The additional elements of claims 1, 13, and 19, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the implantable medical device, processor, and communication circuit, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer.
Dependent claims 2-12 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1. The dependent claim limitations are directed to generic component functions necessary to implement the abstract idea (Claims 2-8) amounting to mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a)., further defining data analysis limitations (Claims 4) data analysis (Claims 8 & 10-12), and displaying results or information (Claims 9 & 11-12) which amounts to data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Dependent claims 14-18 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 13. The dependent claim limitations are directed to generic component functions necessary to implement the abstract idea (Claim 16-18) amounting to mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a)., and further defining data analysis limitations (Claims 14-15) which amounts to data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Dependent claim 20 does not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 19. The dependent claim limitations are directed to generic component functions necessary to implement amounting to mere instructions to apply the exception in a generic way, see MPEP §2106.04(d)(2)(a).the abstract idea and defining data analysis which amounts to data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)]..
In summary, claims 1-20 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brisben et al. (US Publication No. 20170113053).
Regarding claim 1, Brisben discloses method of monitoring operation of a cardiac implantable medical device (IMD) (Brisben Abstract “monitoring of cardiac signal quality for external and/or implantable cardiac devices.”) operating a communication circuit configured to communicate wirelessly with the IMD in a remote monitoring (RM) session that generates RM session data (Brisben ¶0021 “The canister 12 may further include such components as would be appropriate for communication (such as RF communication, inductive telemetry or other suitable communication linkage) with an external device such as a programmer 22, or remote monitoring device. “); analyzing the RM session data to determine sensing quality for the IMD (Brisben ¶0021 “ the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”) wherein: the RM session data includes data for a plurality of counters present in the IMD (Brisben Figure 8 as described in ¶0062-¶0064 showing multiple counters being used in the diagram); and the step of analyzing the RM session data to determine sensing quality for the IMD is performed by: analyzing data in the plurality of counters (Brisben Figure 8 blocks 322, 340, & 342); determining from the data in the plurality of counters that the IMD has experienced a drop in signal quality (Brisben Figure 8 blocks 344 & 346); and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality (Brisben Figure 8 block 350).
Regarding claims 2, claim 1 is anticipated by Brisben. Brisben further discloses wherein the counter data does not include cardiac signal representations, such that analysis of RM session data to determine sensing quality occurs without reviewing cardiac signal representations (Brisben Figure 12 as discussed in ¶0091-¶0092; ¶0092 “Rate mismatch 542 can also be a trigger, where a mismatch can be found if a cardiac cycle rate calculated by a given sensing configuration or vector does not match a rate as calculated using a different sensing vector, or a rate as calculated by a different method (autocorrelation instead of cardiac cycle detection), or using different data (using heart sounds, blood pressure changes or pulse oximetry, for example),” Where the mismatch can be determined by non cardiac waveform analysis. ).
Regarding claim 3, claim 1 is anticipated by Brisben. Brisben further discloses wherein the RM session data comprises data from a Tachy counter, the data in the Tachy counter indicating how frequently the IMD transitions between a first state in which cardiac rate is characterized as non-Tachycardia, and a second state in which the cardiac rate is characterized as Tachycardia or Fibrillation. (Brisben ¶0079 discussing trigger types, such as elevated heart rate (i.e tachycardia) which would be tracked by Figure 8 methods which counts events and determines a signal quality with qualifying events; where this episode is indicative of tachycardia rather than other events; ¶0038 “For example, a rate validation trend may determine how closely a cardiac cycle or beat based rate analysis matches a validation analysis from another vector, source or method; absolute mismatch or a trend away from matching may be observed. In other examples, the frequency with which a poor signal quality marker (such as low SNR or amplitude, or identified noise, saturation, baseline wander, or overdetection) occurs may be tracked; increasing frequency would indicate a loss of signal quality.”).
Regarding claim 4, claim 1 is anticipated by Brisben. Brisben further discloses wherein the step of analyzing data in the plurality of counters occurs in a processor of a remote monitoring device for the IMD , the remote monitoring device also including a communication circuit which also performs the communication step. (Brisben ¶0021 showing that programmer 22 functions as both a processor by controlling signal analysis, and a communication component as it communicates with the implanted device and the medical practitioner remotely).
Regarding claim 5, claims 1 & 4 are anticipated by Brisben. Brisben further discloses the remote monitoring device instructing the IMD to take a corrective action in response to an alert to modify a setting or parameter in the IMD. (Brisben ¶0021 “ the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”; Figure 8 block 352).
Regarding claim 6, claim 1 is anticipated by Brisben. Brisben further discloses wherein the communication step is performed by a remote monitoring device which is communicatively coupled to a customer service center, and the analyzing step is performed at the customer service center. (Brisben ¶0021 “the programmer 22 may be used to activate the canister 12 and/or direct/observe diagnostic or operational tests. After implantation, the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.” Where the examiner is interpreting programmer 22 as the customer service center since the programmer allows communication to the medical practitioner).
Regarding claim 7, claims 1 & 6 are anticipated by Brisben. Brisben further discloses the remote monitoring device instructing the IMD to take a corrective action in response to an alert to modify a setting or parameter in the IMD. (Brisben ¶0021 “ the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”; Figure 8 block 352).
Regarding claim 8, claim 1 is anticipated by Brisben. Brisben further discloses wherein: the IMD is configured to analyze the cardiac signals and determine whether a sensing circuit of the IMD becomes saturated by the cardiac signals (Briben ¶0038 “ In other examples, the frequency with which a poor signal quality marker (such as low SNR or amplitude, or identified noise, saturation, baseline wander, or overdetection) occurs may be tracked; increasing frequency would indicate a loss of signal quality.”), and the IMD includes a saturation counter for counting how frequently the sensing circuit becomes saturated by the cardiac signals; the RM session data includes saturation counter data; and the analyzing step is performed by: determining whether the saturation counter data crosses a saturation counter data threshold (Brisben Figure 8 wich shows a general tracking of trends affecting signal quality, which includes triggering events(¶0063 “The data may be analyzed as it is gathered and accumulated or analysis may take place in response to a triggering condition. “). and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality. (Brisben Figure 8 step 350).
Regarding claim 9, claims 1 is anticipated by Brisben. Brisben further discloses the IMD is configured to analyze the cardiac signals to sense detected events, to analyze the detected events to identify noise, and includes a noise counter that counts how frequently detected events are identified as noise (Brisben ¶0040 “In an illustration, repeated identification of noise or overdetection may be used as a trigger to perform an overall signal quality analysis in which sensing may be reconfigured.”); the RM session data includes noise counter data (Brisben Figure 8 block 322 where the trends include noise (as described in ¶0062-¶0063); and the analyzing step is performed by: determining whether the noise counter data crosses a noise counter data threshold (Brisben Figure 8 Block 322 where the parallel analysis track blocks 306-310 identify noise (¶0063) and categorize trend types according to a threshold (block 322)) and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality. (Brisben Figure 8 step 350).
Regarding claim 10, claim 1 is anticipated by Brisben. Brisben further discloses wherein: the IMD is configured to analyze the cardiac signals to sense detected events, to analyze the detected events to identify noise, and includes a persistent noise counter that counts how frequently sets of consecutive detected events are all identified as noise (Brisben ¶0040 “In an illustration, repeated identification of noise or overdetection may be used as a trigger to perform an overall signal quality analysis in which sensing may be reconfigured.”); the RM session data includes persistent noise counter data; and the analyzing step is performed by: determining whether the persistent noise counter data crosses a persistent noise counter data threshold (Brisben Figure 8 which shows a general tracking of trends affecting signal quality, which includes triggering events(¶0063 “The data may be analyzed as it is gathered and accumulated or analysis may take place in response to a triggering condition. “).and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality. (Brisben Figure 8 step 350).
Regarding claim 11, claim 1 is anticipated by Brisben. Brisben further discloses wherein: the IMD is configured to analyze the cardiac signals to sense detected events, to analyze the detected events by comparison to a template, and includes a persistent mismatch counter that counts how frequently sets of consecutive detected events are all identified as not matching the template; the RM session data includes persistent mismatch counter data (Brisben ¶0090 “Another trigger may be mismatch to a template at 534. Template mismatch 534 can include persistent failure of detected cardiac cycles to match a static (fixed and stored) or dynamic (continuously changing or changing from time to time as for example where the template is simply a copy of a previously detected cardiac cycle) template.”); and the analyzing step is performed by: determining whether the persistent mismatch counter data crosses a persistent mismatch counter data threshold (Brisben Figure 8 wich shows a general tracking of trends affecting signal quality, which includes triggering events(¶0063 “The data may be analyzed as it is gathered and accumulated or analysis may take place in response to a triggering condition. “).and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality. (Brisben Figure 8 step 350).
Regarding claim 12, claim 1 is anticipated by Brisben. Brisben further teaches wherein: the IMD is configured to analyze the cardiac signals to sense detected events, and to analyze the detected events to identify over detection, and includes an over detection counter that counts how frequently the IMD identifies over detected events: the RM session data includes over detection counter data(Brisben ¶0062 “A signal analysis track is shown at 306/308/310 as including event detection 306, certification of the event at 308 (which may include the identification and elimination of noise or overdetection, for example), and calculation of the heart rate 310.”); and the analyzing step is performed by: determining whether the over detection counter data crosses a over detection counter data threshold (Brisben Figure 8 wich shows a general tracking of trends affecting signal quality, which includes triggering events(¶0063 “The data may be analyzed as it is gathered and accumulated or analysis may take place in response to a triggering condition. “)and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality. (Brisben Figure 8 step 350).
Regarding claim 13, Brisben discloses a system for remotely monitoring a cardiac implantable medical device (IMD) (Brisben ¶0021 “ the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”; Abstract), the system comprising: a communication circuit configured to communicate wirelessly with a cardiac IMD in a remote monitoring (RM) session that generates RM session data (Brisben ¶0021 “The canister 12 may further include such components as would be appropriate for communication (such as RF communication, inductive telemetry or other suitable communication linkage) with an external device such as a programmer 22, or remote monitoring device. “) configured to analyze RM session data to determine sensing quality for the IMD (Brisben ¶0021 “ the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”), wherein: the RM session data includes data for a plurality of counters present in the IMD (Brisben Figure 8 as described in ¶0062-¶0064 showing multiple counters being used in the diagram); and the processor is configured to analyze RM session data to determine sensing quality for the IMD by: analyzing data in the plurality of counters (Brisben Figure 8 blocks 322, 340, & 342); determining from the data in the plurality of counters that the IMD has experienced a drop in signal quality (Brisben Figure 8 blocks 344 & 346); and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality (Brisben Figure 8 step 350).
Regarding claim 14, Claim 13 is anticipated by Brisben. Brisben further discloses wherein the counter data does not include cardiac signal representations, such that the processor analyzes the RM session data to determine sensing quality without reviewing cardiac signal representations. (Brisben Figure 12 as discussed in ¶0091-¶0092; ¶0092 “Rate mismatch 542 can also be a trigger, where a mismatch can be found if a cardiac cycle rate calculated by a given sensing configuration or vector does not match a rate as calculated using a different sensing vector, or a rate as calculated by a different method (autocorrelation instead of cardiac cycle detection), or using different data (using heart sounds, blood pressure changes or pulse oximetry, for example),” Where the mismatch can be determined by non cardiac waveform analysis. ).
Regarding claim 15, Claim 13 is anticipated by Brisben. Brisben further discloses wherein the RM session data comprises data from a Tachy counter, the data in the Tachy counter indicating how frequently the IMD transitions between a first state in which cardiac rate is characterized as non-Tachycardia, and a second state in which the cardiac rate is characterized as Tachycardia or Fibrillation. (Brisben ¶0079 discussing trigger types, such as elevated heart rate (i.e tachycardia) which would be tracked by Figure 8 methods which counts events and determines a signal quality with qualifying events; where this episode is indicative of tachycardia rather than other events; ¶0038 “For example, a rate validation trend may determine how closely a cardiac cycle or beat based rate analysis matches a validation analysis from another vector, source or method; absolute mismatch or a trend away from matching may be observed. In other examples, the frequency with which a poor signal quality marker (such as low SNR or amplitude, or identified noise, saturation, baseline wander, or overdetection) occurs may be tracked; increasing frequency would indicate a loss of signal quality.”).
Regarding claim 16, Claim 13 is anticipated by Brisben. Brisben further discloses wherein the processor and communication circuit are both contained in a remote monitoring device. (Brisben ¶0102 “The programmer 22 and implantable device 12 may communicate with one another using, for example and without limitation, inductive or RF telemetry, or any other suitable communication solution. The present invention may be embodied in a system having any such characteristics.”; ¶0021 “The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”).
Regarding claim 17, Claim 13 is anticipated by Brisben. Brisben further discloses wherein the communication circuit is contained in a remote monitoring device which is communicatively coupled to a customer service center, and the processor is part of the customer service center. (Brisben ¶0021 “The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.” Where the examiner is interpreting the user interface which allows communication to the medical practitioner as the customer service center).
Regarding claim 18, Claims 13 & 17 are anticipated by Brisben. Brisben further discloses wherein the remote monitoring device is configured to communicate to the IMD to take a corrective action in response to an alert. (Brisben ¶0021 “ the programmer 22 (or remote monitoring device, such as a bedside monitor) may be used to non-invasively determine the status and history of the implanted device. The programmer 22 in combination with the canister 12 may also allow reporting of statistics, errors, history and potential problems to the user/medical practitioner, and may also allow for updating of programming in the canister 12.”; Figure 8 block 352).
Regarding claim 19, Brisben discloses method of monitoring operation of a cardiac implantable medical device (IMD) (Brisben Abstract “monitoring of cardiac signal quality for external and/or implantable cardiac devices.”), the IMD maintaining a plurality of counters for events that the IMD identifies, the method comprising: analyzing data in the plurality of counters (Brisben Figure 8 blocks 322, 340, & 342); determining from the data in the plurality of counters that the IMD has experienced a drop in signal quality (Brisben Figure 8 blocks 344 & 346); and, if so, generating an alert indicating that the IMD has experienced a drop in signal quality (Brisben Figure 8 step 350)or modifying an operating parameter of the IMD. (Brisben Figure 8 step 352).
Regarding claim 20, claim 19 is anticipated by Brisben. Brisben further discloseswherein the plurality of counters includes a Tachy counter, the data in the Tachy counter indicating how frequently the IMD transitions between a first state in which cardiac rate is characterized as non-Tachycardia, and a second state in which the cardiac rate is characterized as Tachycardia or Fibrillation, and the determining step is performed by comparing the data in the Tachy counter to one or more thresholds. (Brisben ¶0079 discussing trigger types, such as elevated heart rate (i.e tachycardia) which would be tracked by Figure 8 methods which counts events and determines a signal quality with qualifying events; where this episode is indicative of tachycardia rather than other events; ¶0038 “For example, a rate validation trend may determine how closely a cardiac cycle or beat based rate analysis matches a validation analysis from another vector, source or method; absolute mismatch or a trend away from matching may be observed. In other examples, the frequency with which a poor signal quality marker (such as low SNR or amplitude, or identified noise, saturation, baseline wander, or overdetection) occurs may be tracked; increasing frequency would indicate a loss of signal quality.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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