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 .
Priority
In that the PCT application and the Chinese priority application are not in the English language, the effective filing date of this application could be 08/05/2022 if the originally-filed PCT application, of which this application is a CIP, provides support for the claimed subject matter.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pulse stimulation device having two control electrodes, a pulse control module having a stimulation combination with two stimulation units, and the pulse stimulation device having a time updated module must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show how a difference between the second R-wave sensing time and the first R-wave sensing time of each preset stimulation position is calculated as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). In particular, while Figs. 2 and 4 show a ECG signal and three EGM signals, the drawings do not show how the ECG and EGM signals and their difference correspond to preset stimulation positions. In addition, the drawings do not show how the control electrode corresponds to a preset stimulation position, nor do the Figures show how the preset stimulation position corresponds to the pulse delivery times and the difference between first and second delivery times.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: GSLD, GPD.
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 9-15 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. Paragraph [0093] of the originally-filed specification describes a time difference GLSD between the corresponding R-wave sensing time of the surface electrocardiogram (ECG) and the corresponding R-Wave sensing time of the local myocardial electrocardiogram (EGM), but does not show how or where the time difference is calculated or located. Where is the reference zero point that is used to calculate the second pulse delivery time? Consequently, one of ordinary skill in the art would not have recognized that the inventors, at the time the application was filed had possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, lines 7-9, recites that “the R-wave sensing module is used to obtain a surface electrocardiogram and/or obtain a myocardial electrocardiogram”. That is, the independent claim functionally recites two different electrocardiogram can be obtained. However, claim 1, lines 10-12 recites “the myocardial electrocardiogram” and “the surface electrocardiogram “ without first positively reciting that both electrocardiograms are obtained. Thus, the recitation of “the myocardial electrocardiogram” and “the surface electrocardiogram” in lines 10-12 is indefinite because in at least one scenario of the claim only one electrocardiogram type is obtained.
In claim 1, line 17, the recitation “for CCM” is vague and indefinite because it is unclear what “CCM” is intended to means as there are numerous possibilities.
In claim 1, line 17, the recitation of “the corresponding control electrode” has insufficient antecedent basis as lines 2-3 of the claim recite “the control electrode corresponds to a preset stimulation position”. It is unclear if the corresponding control electrode refers to the control electrode of line 2 or if the corresponding control electrode is another electrode.
With respect to claim 3, lines 6-9, the recitation of “each corresponding control electrode”, “each first pulse delivery time” and “each second pulse delivery time” is vague and indefinite because it is unclear where multiple control electrodes and multiple delivery times came from.
Claims 4 (line 2), 8 (lines 3, 5, 7-8), 9 (lines 2, 5-6), 13 (lines 8, 10, 11-12) refer to “each preset stimulation position” and “the independent claim recites “the control electrode corresponds to a preset stimulation position” (i.e., only one preset stimulation position). Thus, the recitation of “each preset stimulation position” in claims 4, 8-9, and 13 is vague and indefinite.
The recitation of “the myocardial electrocardiogram” and “the surface electrocardiogram” in line 4 of claim 4 is indefinite because in at least one scenario of the claim only one electrocardiogram type is obtained.
Claim 5, line 8, the recitation of “the pulse delivery pattern comprises delivering a cardiac stimulation pulse …” is confusing as claim 3, from which claim 5 depends, recites “the cardiac stimulation pulse generator is used to deliver a cardiac stimulation pulse … based on the pulse delivery pattern. A pattern does not deliver.
With respect to claim 8, the recitation of “each corresponding control electrode” in lines 7-8 is confusing as it is unclear where an additional control electrode came from.
With respect to claims 8-9, and 13, the recitation of the word “also” is confusing. In claim 8, it is unclear what “also” intends to convey as the base claim determines one of a first pulse delivery time and a second pulse delivery time, but only one type of electrocardiogram is obtained.
Claim 14 recites the limitation "the preset duration" in line 7 (last line). There is insufficient antecedent basis for this limitation in the claim as claim 1 does not mention a preset duration.
The recitation of “the myocardial electrocardiogram” and “the surface electrocardiogram” in lines 2-3 of claim 16 and line 2 of claim 17 is indefinite because in at least one scenario of the claim only one electrocardiogram type is obtained. Further, the scope of the claim is indefinite because it is unclear if both a myocardial electrogram and a surface electrocardiogram, as set forth in claim 1, are obtained.
Claims 2, 6-7, 10-12, 15, and 18-20 are rejected because they depend from an indefinite claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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 1-7, 14-15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2020/0146580 to Sarkar et a. (hereinafter referred to as “Sarkar”).
Regarding claim 1, Sarkar discloses a pulse stimulation device (e.g., paragraph [0026]: pacemaker 14 produces electrical stimulation pulses), comprising an R-wave sensing module (e.g., Fig. 3, 224), a cardiac stimulation pulse generator (e.g., Fig. 3, 202), and at least one control electrode (e.g., paragraphs [0033]-[0034]; [0056]; and Figs. 2-3, 164), wherein the control electrode corresponds to a preset stimulation position (e.g., paragraph [0026] and Fig. 2, 164); the control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator (e.g., Fig. 3, electrode 164 is connected to R-wave detector 224 and pulse generator 202), respectively, and the R-wave sensing module is communicatively connected to the cardiac stimulation pulse generator (e.g., Fig. 3, R-sense signal of the R-wave detector is communicatively coupled to the pulse generator via control circuit 206); the R-wave sensing module is used to obtain a surface electrocardiogram and/or obtain a myocardial electrocardiogram by collecting an electrocardiogram signal based on the control electrode (e.g., paragraphs [0020]-[0021]; [0048]; [0126]; [0128]; and Figs. 11-12, 804/824); obtain a first R-wave sensing time of an R-wave occurrence based on the myocardial electrocardiogram and/or a second R-wave sensing time of an R-wave occurrence based on the surface electrocardiogram (e.g., paragraph [0048]: R-wave sensed event signals may be used in setting one or more timing windows); and determine a first pulse delivery time corresponding to the preset stimulation position according to the first R-wave sensing time and/or a second pulse delivery time corresponding to the preset stimulation position according to the second R-wave sensing time (e.g., paragraphs [0048]-[0050]: control circuit 206 may receive R-wave sensed event signals for controlling ventricular pacing via pace timing circuit 242 for scheduling pacing pulses); the cardiac stimulation pulse generator is used to deliver a cardiac electrical stimulation pulse for CCM (intended use of the cardiac electrical stimulation pulse) to the corresponding control electrode according to the first pulse delivery time and/or the second pulse delivery time (e.g., paragraphs [0026]-[0027]: pacemaker 14 controls pacing pulse delivery and delivers pacing pulses via electrodes on its outer housing; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave).
With respect to claim 2, Sarkar discloses the pulse stimulation device according to claim 1, wherein the device comprises at least two control electrodes, and different control electrodes are used for being implanted at different preset stimulation positions in the left ventricular myocardium and/or right ventricular myocardium of a patient (e.g., paragraphs [0024]: pacemaker 14 is implanted in the right ventricle or the left ventricle for sensing cardiac signals and delivering pacing pulses; [0026]: pacing pulses are delivered to heart 8 via one or more electrodes; [0034]: pacemaker may include two or more ring electrodes, two tip electrodes and other types of electrodes exposed along housing 150; Figs. 1-3).
As to claim 3, Sarkar discloses the pulse stimulation device according to claim 1, wherein the device further comprises a pulse control module (e.g., Fig. 3, 206), and the pulse control module is communicatively connected to the cardiac stimulation pulse generator (e.g., Fig. 3 pulse control module is communicatively connected to pulse generator 202); the pulse control module is used to generate a pulse delivery pattern and send the pulse delivery pattern to the cardiac stimulation pulse generator (e.g., paragraph [0027]: pacemaker 14 controls ventricular pacing in a manner that promotes synchrony between atrial and ventricular activation; i.e., pacemaker 14 paces the heart tissue in a synchronized pattern; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0050]-[0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave via control circuit 206); the cardiac stimulation pulse generator is used to deliver a cardiac stimulation pulse to each corresponding control electrode based on the pulse delivery pattern and each first pulse delivery time and/or each second pulse delivery time upon the occurrence of an R wave in the surface electrocardiogram and/or the myocardial electrocardiogram (e.g., [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave).
With respect to claim 4, Sarkar discloses the pulse stimulation device according to claim 3, wherein the pulse delivery pattern comprises delivering a cardiac stimulation pulse to the control electrode corresponding to each preset stimulation position in a synchronized manner and in a set or random order, based on the R wave in the surface electrocardiogram and/or the myocardial electrocardiogram generator (e.g., paragraph [0027]: pacemaker 14 controls ventricular pacing in a manner that promotes synchrony between atrial and ventricular activation; i.e., pacemaker 14 paces the heart tissue in a synchronized pattern; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0050]-[0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave via control circuit 206).
As to claim 5, Sarkar discloses the pulse stimulation device according to claim 3, wherein the pulse control module is also used to generate a stimulation combination corresponding to different preset stimulation positions based on a set number of the preset stimulation positions, using a set construction rule or a random combination; wherein the stimulation combination comprises at least two stimulation units, and at least one of the stimulation units corresponds to two or more of the preset stimulation positions where the pulse is delivered in a synchronized manner (e.g., paragraph [0034]: pacemaker may include two or more ring electrodes, two tip electrodes and other types of electrodes exposed along housing 150; Figs. 1-3; i.e., in embodiment with two tip and two ring electrodes, the control module would necessarily generate a stimulation combination for each electrode pair); the pulse delivery pattern comprises delivering a cardiac stimulation pulse to the control electrode corresponding to the preset stimulation position in accordance with a set or random order and the stimulation combination, based on the R wave in the surface electrocardiogram and/or the myocardial electrocardiogram generator (e.g., paragraph [0027]: pacemaker 14 controls ventricular pacing in a manner that promotes synchrony between atrial and ventricular activation; i.e., pacemaker 14 paces the heart tissue in a synchronized pattern; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0050]-[0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-waves via control circuit 206).
With respect to claim 6, Sarkar discloses the pulse stimulation device according to claim 4, wherein the cardiac stimulation pulse is capable of being successively delivered to the corresponding preset stimulation position in a set or random order to achieve a preset number of heartbeats (e.g., paragraph [0024]: pacemaker 14 delivers ventricle pacing pulses (more than one, which implies successive pacing pules where a pacemaker controls irregular heart rhythm/heart beats) .
As to claim 7, Sarkar discloses the pulse stimulation device according to claim 1, wherein the preset stimulation position comprises at least one of an inner wall of the interventricular septum of the left ventricle and/or right ventricle, an interventricular sulcus of the outer wall of the ventricle, an lateral wall of the left ventricle, an anterolateral wall of the left ventricle, a posterolateral wall of the left ventricle, an inner wall of a right ventricular free wall, an outer wall of the right ventricular free wall, a right ventricular apex, and a left ventricular apex (e.g., paragraph [0025]: pacemaker 14 is positioned in the right ventricle, along an endocardial wall near the RV apex as shown in Fig. 1).
With respect to claim 14, Sarkar discloses the pulse stimulation device according to claim 1, wherein the R-wave sensing module is capable of obtaining multiple first R-wave sensing times corresponding to the R-wave occurrences in the myocardial electrocardiograms at multiple preset stimulation positions, to select one first R-wave sensing time as a reference zero point (e.g., paragraph [0096]), calculating a second difference between each first R-wave sensing time following the reference zero point and the reference zero point (e.g., paragraph [0096]: two consecutive VCL differences generate one data point), and calculating the first pulse delivery time corresponding to each preset stimulation position based on the second difference and the preset duration (e.g., paragraphs [0026]-[0027]: pacemaker 14 controls pacing pulse delivery and delivers pacing pulses via electrodes on its outer housing; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave).
As to claim 15, Sarkar discloses the pulse stimulation device according to claim 14, wherein the R-wave sensing module is capable of selecting the first R-wave sensing time with the earliest time of occurrence as the reference zero point (e.g., paragraph [0096]: one VCL is determined between two consecutively identified ventricular events (V1, V2) where V2 follows V1 – thus V1 is the earliest time of occurrence).
Referring to claim 18, Sarkar discloses a pulse stimulation method, which is implemented using the pulse stimulation device according to claim 1 (see rejection of claim 1 above), comprising: obtaining a surface electrocardiogram and/or obtaining a myocardial electrocardiogram by collecting an electrocardiogram signal based on the control electrode (e.g., paragraphs [0020]-[0021]; [0048]; [0126]; [0128]; and Figs. 11-12, 804/824); obtaining a first R-wave sensing time of an R-wave occurrence based on the myocardial electrocardiogram and/or a second R-wave sensing time of an R-wave occurrence based on the surface electrocardiogram (e.g., paragraph [0048]: R-wave sensed event signals may be used in setting one or more timing windows based on the myocardial electrocardiogram); determining a first pulse delivery time corresponding to the preset stimulation position based on the first R-wave sensing time and/or a second pulse delivery time corresponding to the preset stimulation position based on the second R-wave sensing time; and delivering a cardiac stimulation pulse for CCM to the control electrode based on the first pulse delivery time or the second pulse delivery time (e.g., paragraphs [0048]-[0050]: control circuit 206 may receive R-wave sensed event signals for controlling ventricular pacing via pace timing circuit 242 for scheduling pacing pulses); the cardiac stimulation pulse generator is used to deliver a cardiac electrical stimulation pulse for CCM (intended use of the cardiac electrical stimulation pulse) to the corresponding control electrode according to the first pulse delivery time and/or the second pulse delivery time (e.g., paragraphs [0026]-[0027]: pacemaker 14 controls pacing pulse delivery and delivers pacing pulses via electrodes on its outer housing; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave).
With respect to claim 19. A medical apparatus (e.g., paragraph [0001]: an implantable medical device), comprising the pulse stimulation device according to claim 1 see rejection of claim 1 above).
As to claim 20 Sarkar discloses the medical apparatus according to claim 19, wherein the medical apparatus comprises one or more than one of a pacing system (e.g., paragraph [0024]: intracardiac pacing system), a defibrillator system, an S-ICD system, or an implantable device that provides mechanical circulatory support.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sarkar as applied to claim 1 above, and further in view of US Patent Application Publication No. 2020/0289829 to Ghosh.
As to claim 8, Sarkar discloses the pulse stimulation device according to claim 1, wherein the R-wave sensing module is [also?] used to calculate the first pulse delivery time corresponding to each preset stimulation position based on the first R-wave sensing time (e.g., paragraphs [0048]-[0050]: control circuit 206 may receive R-wave sensed event signals for controlling ventricular pacing via pace timing circuit 242 for scheduling pacing pulses); the cardiac stimulation pulse generator is used to deliver the cardiac stimulation pulse to each corresponding control electrode based on the first pulse delivery time (e.g., paragraphs [0026]-[0027]: pacemaker 14 controls pacing pulse delivery and delivers pacing pulses via electrodes on its outer housing; [0040]: pacemaker 14 and electrode 164 are positioned in operative proximity to a targeted tissue for delivering therapeutic electrical stimulation pulses; and [0051]: pulse generator 202 delivers pacing pulse based on timing determined by sensed R-wave); but, as best understood, does not expressly disclose that the R-wave sensing module is also used to calculate the second pulse delivery time corresponding to each preset stimulation position based on the first R-wave sensing time and the second R-wave sensing. However, Ghosh, in a related art: cardiac resynchronization therapy, teaches 1) pacing delay between RV electrode and a LV electrode may be calibrated or optimized using a separate medical device (e.g., ECG belt) (e.g., paragraph [0050] of Ghosh); and 2) that activation times (including measuring appropriate fiducial points such as peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing , a threshold crossing of QRS complexes) of different regions of a patient’s heart can be approximated from surface electrocardiogram (ECG) activation times measured using surface electrodes in proximity to surface areas corresponding to different regions of the patient’s heart (e.g., paragraphs [0146]-[0150] and [0155] of Ghosh) and that its sensing circuit detects the existence of R-waves and sends the same to the control circuit for processing and analysis (e.g., paragraph [0045] of Ghosh). Accordingly, one of ordinary skill in the art would have recognized the benefits of obtaining a surface electrode electrocardiogram, detecting the presence of R-wave occurrences in a surface electrocardiogram using surface electrodes, and calculating a pulse delivery time based on the surface electrocardiogram in view of the teachings of Ghosh. Consequently, one of ordinary skill in the art would have modified the pulse stimulation device of Sarkar to obtain surface electrocardiogram (ECG) activation times using surface electrodes and calculating a pulse delivery time based on the surface electrocardiogram using Sakar’s control circuit, in addition, to obtaining the myocardial electrocardiogram using the control electrode of an implanted stimulation device, in view of the teachings of Ghosh that a separate medical device such as an ECG belt may be used to determine pulse delivery time and that activation times (including measuring appropriate fiducial points such as peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing , a threshold crossing of QRS complexes) of different regions of a patient’s heart can be approximated from surface electrodes as taught by Ghosh in order to provide a check on the internal measurements (or calibrate the measurements), and because the combination would have yielded a predictable result.
With respect to claim 16, Sarkar discloses the pulse stimulation device according to claim 1, wherein the R-wave sensing time of the R-wave occurrence obtained is based on the myocardial electrocardiogram, but, as the claim is best understood, does not expressly disclose that a second R-wave sensing is obtained based on a surface electrocardiogram where the myocardial electrocardiogram and the surface electrocardiogram correspond to the same heartbeat. However, Ghosh, in a related art: cardiac resynchronization therapy, teaches that activation times (including measuring appropriate fiducial points such as peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing , a threshold crossing of QRS complexes) of different regions of a patient’s heart can be approximated from surface electrocardiogram (ECG) activation times measured using surface electrodes in proximity to surface areas corresponding to different regions of the patient’s heart (e.g., paragraphs [0146]-[0150] and [0155] of Ghosh) and that its sensing circuit detects the existence of R-waves and sends the same to the control circuit for processing and analysis (e.g., paragraph [0045] of Ghosh). Accordingly, one of ordinary skill in the art would have recognized the benefits of obtaining a surface electrode electrocardiogram, detecting the presence of R -wave occurrences in a myocardial electrocardiogram using an implanted medical device and a surface electrocardiogram using surface electrodes where the detected R-wave of both electrocardiogram corresponds to the same heartbeat in view of the teachings of Ghosh. Consequently, one of ordinary skill in the art would have modified the pulse stimulation device of Sarkar to further include surface electrodes for recording surface electrocardiogram (ECG) activation times using surface electrodes, in addition, to the control electrode of an implanted stimulation device, in view of the teachings of Ghosh that activation times (including measuring appropriate fiducial points such as peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing , a threshold crossing of QRS complexes) of different regions of a patient’s heart can be approximated from surface electrodes as taught by Ghosh in order to provide a check on the internal measurements, and because the combination would have yielded a predictable result.
As to claim 17, Sarkar discloses the pulse stimulation device according to claim 1, wherein the R-wave sensing module is capable of obtaining the surface electrocardiogram and the myocardial electrocardiogram as taught by Ghosh above; but does not expressly teach the following function: when the surface electrocardiogram sensing is poor, the R-wave sensing module is used to obtain the first R-wave sensing time of the R-wave occurrence based on the myocardial electrocardiogram, and to determine the first pulse delivery time corresponding to the preset stimulation position according to the first R-wave sensing time; when the myocardial electrocardiogram sensing is poor, the R-wave sensing module is used to obtain the second R-wave sensing time of the R-wave occurrence based on the surface electrocardiogram, and to determine the second pulse delivery time corresponding to the preset stimulation position according to the second R-wave sensing time.
However, as discussed above w/r/t claim 16, Ghosh teaches that surface ECG electrodes can record/measure ECG signals from which activation times of different regions of the patient’s heart can be approximated. Ghosh further teaches that electrical activation times of the patient’s heart may be useful to calibrate, deliver, or evaluate cardiac therapy to be or being delivered to a patient (e.g., paragraph [0145]). Accordingly, one of ordinary skill in the art would have recognized the benefits of obtaining both an electrocardiogram obtained using surface electrodes and an electrocardiogram using implanted control electrodes in view of the teachings of Ghosh. Consequently, one of ordinary skill in the art would have modified the pulse stimulation device of Sarkar to have surface electrodes for generating a surface electrocardiogram, in addition to its myocardial electrocardiogram obtained with a control electrode so that surface electrodes can detect R-waves when the implanted electrodes are not working/not sensing and to determine the second pulse delivery time in order to provide the necessary cardiac therapy in view of the teachings of Ghosh that such activation times can be achieved with either surface electrodes or implanted control electrodes, and because the combination would have yielded a predictable result.
Allowable Subject Matter
Claims 9-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Indicating Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: As best understood, claims 9 and 13 calculate (implies a processor) a first time difference between an R-wave sensing time based on a myocardial electrocardiogram and another R-wave sensing time based on a surface electrocardiogram. As of the date of this Office Action, the Examiner has not identified any reference that can be used singularly or in combination with another reference including Sakar and Ghosh to render such an invention anticipated or obvious to one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2024/0181269 to Ben David et al. (EFD 04/04/2022) is directed to a method of anti-tachycardia pacing via an implanted device where, in some embodiments, a predetermined time delay is selected according to a time difference between R-wave occurrences measured via at least two electrodes at the at least two different cardiac locations (e.g., paragraphs [0040]-[0041]). But, the electrodes of Ben David are implanted. Thus, Ben David does not teach calculating a time difference between time differences based on a surface electrocardiogram using surface electrodes and a myocardial electrocardiogram using implanted control electrodes as required by the claims.
US Patent Application Publication No. 20204/0001127 to Prutchi et al. (EFD 03/29/2022) is directed to lead positioning for an implantable pulse generator where the electrodes receive cardiac contractility modulation stimulation based on a time difference (e.g., abstract and paragraph [0019]).
US Patent No. 5,540,725 to Bornzin et al. is directed to an implantable pacemaker where the cardiac rhythm can be recorded by an electrocardiogram (ECG) or electrogram (EGM) and ventricular depolarization (represented by an R-wave) can be detected from either an ECG or EGM (e.g., column 1, lines 45-64).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792