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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 17th, 2024 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63/271,903, filed on October 26th, 2021. Examiner acknowledges the applicant’s claim for priority.
Claim Objections
Claim 12 is objected to because of the following informalities: “therebetween” should contain a space between the words on claim 12.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “processing module” in claims 1 and 15 and all dependent claims thereof.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses that processing module is formed by electronic circuitry in [0057].
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1
The claims recite subject matter within a statutory category as a process, machine, and/or article of manufacture. However, it will be shown in the following steps, that claims 1-15 are nonetheless unpatentable under 35 U.S.C. 101.
Step 2A Prong One
Claim 1 states:
An implantable medical device for sensing physiological signals, comprising:
an arrangement of at least a first electrode pole, a second electrode pole and a third electrode pole, said arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole being configured to sense physiological signals; and
a processing module for processing physiological signals received via said arrangement of at least the first electrode pole the second electrode pole and the third electrode pole;
wherein the processing module is configured to process different physiological signals received by different pairs of electrode poles of the arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole and to assess a cardiac function based on the processing.
The broadest reasonable interpretation of these steps includes mental processes because each bolded component can practically be performed by the human mind or with pen and paper. Other than reciting generic computer terms like an implantable medical device, nothing in the claims precludes the bold-font portions from practically being performed in the mind. For example, but for the “processing module” language, “process different physiological signals received by different pairs of electrode poles of the arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole and to assess a cardiac function based on the processing” in the context of this claim encompasses a mental process of the healthcare provider determining the patient’s quality of cardiac signaling to address any irregularities. 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. Accordingly, the claim recites an abstract idea.
Thus:
“process different physiological signals received by different pairs of electrode poles of the arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole and to assess a cardiac function based on the processing.”
as drafted, could lay out the mental process of a clinician understanding the various cardiac signals of a patient with the intent to diagnose a patient. Therefore, under the broadest reasonable interpretation, these steps include mental processes as an abstract idea.
Independent claim 15 covers similar steps of sensing physiological signals and processing these signals and assesses a cardiac function based on the received signals. These claims fall under the same category of an abstract idea and follows the same rationale as claim 1.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 14, reciting particular aspects of how “wherein the processing module is configured to assess said cardiac function based on a comparison of at least two of the different physiological signals” may be performed in the mind but for recitation of generic computer components).
Dependent claims 3, 5, 9, and 13 add additional elements to their parent claims which will be further inspected in the following steps for a practical application to their abstract idea.
Step 2A Prong Two
This judicial exception of “Mental Processes” or “Organizing Human Activity” is not integrated into a practical application. Independent claim 1’s apparatus recites additional elements such as an implantable medical device, a processing module, and electrode poles. independent claims 15’s method includes the generic components and additional elements listed above. The implantable medical device, processing module, and electrode poles will be analyzed further for conventionality. In particular, these additional elements do not integrate the abstract idea into a practical application because the additional elements:
add insignificant extra-solution activity to the abstract idea (such as recitation of “said arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole being configured to sense physiological signals” amounts to mere data gathering, recitation of “a processing module for processing physiological signals received via said arrangement of at least the first electrode pole the second electrode pole and the third electrode pole” amounts to selecting a particular data source or type of data to be manipulated, see MPEP 2106.05(g))
generally link the abstract idea to a particular technological environment or field of use (such as “An implantable medical device for sensing physiological signals, comprising: an arrangement of at least a first electrode pole, a second electrode pole and a third electrode pole,”, see MPEP 2106.05(h))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For instance, dependent claim 13 adds an additional element of a housing to their parent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The remaining dependent claims 2, 3, 4, 6-12, and 14 do not recite additional elements or activity but further narrow or define the abstract idea embodied in the claims and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, amount to no more than limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As previously noted, the claim recites an additional element of an implantable medical device. Burnes (US20040220635) demonstrates “The telemetry circuit 330 receives downlink telemetry from and sends uplink telemetry to an external programmer, as is conventional in implantable medical devices” in paragraph [0041] that an additional element was conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
As previously noted, the claim recites an additional element of an electrode pole. Haefner et al. (US20040230243) demonstrates “the electrodes can alternatively be surface electrodes or conventional transvenous, epicardial, and/or endocardial electrodes or combinations of various types of electrodes” in paragraph [0093] that electrode poles were conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more. To elaborate: “a processing module for processing physiological signals received via said arrangement of at least the first electrode pole the second electrode pole and the third electrode pole”, is equivalently, storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv);
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. These additional limitations amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields.
As previously noted, the claim recites an additional element of a housing. Larson et al. (US20030040781) demonstrates “In contrast to a conventional housing implementation, a shallow-drawn IMD housing of the present invention provides for a battery form factor of significantly reduced size” in paragraph [0060] that a housing for an IMD was conventional long before the priority data of the claimed invention. As such, this additional element, individually and in combination with the prior additional element, does not amount to significantly more.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-8, 11, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bardy et al. (US20200029847).
Regarding claim 1, Bardy teaches an implantable medical device for sensing physiological signals, comprising: ([0082] “FIG. 15 is a diagram showing, by way of example, a subcutaneous P-wave centric ICM 212 for long term electrocardiographic monitoring”) an arrangement of at least a first electrode pole, a second electrode pole and a third electrode pole, said arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole being configured to sense physiological signals; and ([0092] “Physically, the ICM 212 has four ECG electrodes 216, 217, 218, 219.”) a processing module for processing physiological signals received via said arrangement of at least the first electrode pole the second electrode pole and the third electrode pole; ([0093] The four ECG electrodes 216, 217, 218, 219 are programmatically controlled by a microcontroller… The sensing circuitry can be programmed, either pre-implant or in situ, to use different combinations of the available ECG electrodes (and thereby changing electrode surface areas, shapes, and inter-electrode spacing), including pairing the two ventral ECG electrodes 216, 217, the two wraparound ECG electrodes 218, 219” where the electrode combinations [i.e., the arrangement of electrode poles] is processed through the processing module [i.e., the microcontroller]) wherein the processing module is configured to process different physiological signals received by different pairs of electrode poles of the arrangement [electron configurations] of at least the first electrode pole, the second electrode pole and the third electrode pole and to assess a cardiac function [diagnostically relevant cardiac events] based on the processing. ([0093] “The four ECG electrodes 216, 217, 218, 219 are programmatically controlled by a microcontroller through onboard firmware programming to enable a physician to choose from several different electrode configurations”; [0046] “A full ECG consists of a stream of alphabetically-labeled waveforms 10” and [0076] “When operated standalone, the monitor recorder 142 senses and records the patient's ECG data 166” where the ECG data comprises different physiological signals; see also [0018] “In a further embodiment, diagnostically relevant cardiac events can be identified as the temporal point of reference.”)
Regarding claim 2, Bardy teaches all of the limitations of claim 1. Bardy also teaches wherein the arrangement contains more than three electrode poles ([0092] “Physically, the ICM 212 has four ECG electrodes 216, 217, 218, 219.”)
Regarding claim 3, Bardy teaches all of the limitations of claim 1. Bardy also teaches wherein the processing module is configured to identify a waveform feature in at least one of the different physiological signals ([0046] “A full ECG consists of a stream of alphabetically-labeled waveforms 10” and [0076] “When operated standalone, the monitor recorder 142 senses and records the patient's ECG data 166” where the ECG data comprises the labeled waveforms)
Regarding claim 4, Bardy teaches all of the limitations of claim 3. Bardy also teaches wherein the waveform feature is a P-wave feature. ([0095] “physician can thus choose to pair the two inner ventral ECG electrodes 222, 223 by themselves to allow for minimal electrode-to-electrode spacing, or with the other ECG electrodes 216, 217, 218, 219 to vary electrode surface areas, shapes, and inter-electrode spacing even further to explore optimal configurations to acquire the P-wave.”)
Regarding claim 6, Bardy teaches all of the limitations of claim 1. Bardy also teaches wherein the processing module [“sensing circuitry”] is configured to determine at least one of a P-wave timing (P-wave “frequency” [0046] and [0082]), a P-wave level (P-wave “amplitude” [0082]), a QRS waveform length ([0074] “QRS interval”), in at least one of the different physiological signals.
Regarding claim 7, Bardy teaches all of the limitations of claim 1. Bardy also teaches wherein the processing module is configured to process the different physiological signals in different processing channels ([0093] “The sensing circuitry can be programmed, either pre-implant or in situ, to use different combinations of the available ECG electrodes (and thereby changing electrode surface areas, shapes, and inter-electrode spacing), including pairing the two ventral ECG electrodes 216, 217, the two wraparound ECG electrodes 218, 219, or one ventral ECG electrode 216, 217 with one wraparound ECG electrode 218, 219 located on the opposite end of the housing 215.” Where programmed to contain different combinations of electrodes comprises processing different physiological channels in different processing channels)
Regarding claim 8, Bardy teaches all of the limitations of claim 7. Bardy also teaches wherein the processing module is configured to perform, in at least one of the different processing channels at least one of an amplification, an analog-to-digital conversion and a filtering. ([0099] “ECG monitoring and other functions performed by the ICM 212 are provided through a micro controlled architecture… The microcontroller 281 has flexible energy management modes and includes a direct memory access controller and built-in analog-to-digital and digital-to-analog converters (ADC and DAC, respectively).” see also [0108] “The ECG front end circuit 283 is organized into a passive input filter stage, a unity gain voltage follower stage, a passive high pass filtering stage, a voltage amplification and active filtering stage, and an anti-aliasing passive filter stage, plus a reference generator.”)
Regarding claim 11, Bardy teaches all of the limitations of claim 1. Bardy also teaches wherein the electrode poles are arranged aligned along a longitudinal axis ([0089] “The ECG electrodes of the ICM 212 are placed primarily in a north-to-south orientation along the sternum 203” comprises aligning along a longitudinal axis)
Regarding claim 12, Bardy teaches all of the limitations of claim 11. Bardy also teaches: wherein the first electrode pole and the second electrode pole define a first signal reception vector therebetween pointing along the longitudinal axis, the second electrode pole and the third electrode pole define a second signal reception vector therebetween pointing along the longitudinal axis, and the first electrode pole and the third electrode pole define a third signal reception vector therebetween pointing along the longitudinal axis ([0093] “The sensing circuitry can be programmed, either pre-implant or in situ, to use different combinations of the available ECG electrodes (and thereby changing electrode surface areas, shapes, and inter-electrode spacing), including pairing the two ventral ECG electrodes 216, 217, the two wraparound ECG electrodes 218, 219, or one ventral ECG electrode 216, 217 with one wraparound ECG electrode 218, 219 located on the opposite end of the housing 215.”; see also [0089] where the orientation of electrodes collects physiological signals along the longitudinal axis)
Regarding claim 13, Bardy teaches all of the limitations of claim 1. Bardy also teaches comprising a housing, wherein the first electrode pole is arranged at a first end of the housing, the second electrode pole is arranged at a second end of the housing opposite the first end, and the third electrode pole is arranged at a location in between said first end and said second end. ([0090] “the ICM 212 is constructed with a hermetically sealed implantable housing 215 with at least one ECG electrode forming a superior pole on the proximal end 213 and at least one ECG electrode forming an inferior pole on the distal end 214.” See also [0092] Physically, the ICM 212 has four ECG electrodes 216, 217, 218, 219. There could also be additional ECG electrodes, as discussed infra. The ECG electrodes include two ventral (or dorsal) ECG electrodes 218, 219 and two wraparound ECG electrodes 216, 217.” Where the wrap around electrodes is contained in between the end electrodes)
Regarding claim 14, Bardy teaches all of the limitations of claim 1. Bardy also teaches wherein the processing module is configured to assess said cardiac function based on a comparison of at least two of the different physiological signals ([0018] “In a further embodiment, diagnostically relevant cardiac events can be identified as the temporal point of reference.” and [0086] “Nevertheless, both the P-wave and the R-wave are required for the physician to make a proper rhythm diagnosis from the dozens of arrhythmias that can occur.” Where cardiac assessment occurs via two physiological signals)
Regarding claim 15, Bardy teaches a method for operating an implantable medical device for sensing physiological signals, comprising: ([0002] This application relates in general to electrocardiographic monitoring and, in particular, to a system and method for event-centered display of subcutaneous cardiac monitoring data”) sensing physiological signals [record an ECG] using an arrangement of at least a first electrode pole, a second electrode pole and a third electrode pole, the first electrode pole; ([0089] “Moreover, the sternal midline implantation location in the parasternal region 211 allows the ICM's electrodes to record an ECG of optimal signal quality” and [0092] “Physically, the ICM 212 has four ECG electrodes 216, 217, 218, 219.”) and processing, using a processing module, signals received via said arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole, wherein the processing module processes different physiological signals received by different pairs of electrode poles of the arrangement of at least the first electrode pole, the second electrode pole and the third electrode pole and assesses a cardiac function [diagnostically relevant cardiac events] based on the processing. ([0093] “The four ECG electrodes 216, 217, 218, 219 are programmatically controlled by a microcontroller through onboard firmware programming to enable a physician to choose from several different electrode configurations”; [0046] “A full ECG consists of a stream of alphabetically-labeled waveforms 10” and [0076] “When operated standalone, the monitor recorder 142 senses and records the patient's ECG data 166” where the ECG data comprises different physiological signals; see also [0018] “In a further embodiment, diagnostically relevant cardiac events can be identified as the temporal point of reference.”)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bardy et al. (US20210038105) in view of Iyer et al. (US20200001094).
Similar to Bardy, Iyer is a system that incorporates “implantable loop recorders… associated with leads that position electrodes or sensors at a desired location, or may be leadless with electrodes integrated into the device housing … to wirelessly transmit data either to another device implanted in the patient or to another instrument” [0005]. Iyer’s publication was a prime teaching resource for improvements in Bardy’s device lifespan, as Iyer indicates “issues related to the implanted medical device may result in a need for a more energy consuming device configuration, which can further shorten the mission life of the implanted device” in paragraph [0028].
Regarding claim 5, Bardy teaches all of the limitations of claim 1. Bardy does not explicitly teach, as taught by Iyer, wherein the processing module is configured to identify a timing relation [pacing] between a right ventricular action potential activity and a left ventricular action potential activity based on the different physiological signals ([0040] “Ventricular lead 22 includes electrodes (not labeled in FIG. 1) positioned on the lead in the patient's right ventricle (RV) for sensing ventricular EGM signals and pacing in the RV… other examples may include one or more additional leads, such as a coronary sinus lead extending into the right atrium, through the coronary sinus and into a cardiac vein to position electrodes along the left ventricle (LV) for sensing LV EGM signals and delivering pacing pulses to the LV” where LV and RV EGM signals comprise different physiological signals) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bardy with the teachings of Iyer, with a reasonable expectation of success, by explicitly directing electrode leads to each chamber of the heart. This would have reduced the noise of any ventricle signal, increasing the accuracy of a heart arrythmia diagnosis.
Regarding claim 9, Bardy teaches all of the limitations of claim 7. Bardy does not explicitly teach, as taught by Iyer wherein the processing module is configured to select one of the different processing channels for monitoring a particular waveform feature based on an identification of the particular waveform feature in the different physiological signals ([0118] “Sensing circuitry 122 may also include switching circuitry to select which of the available electrodes 132 (or electrode polarities) are used to sense the heart activity… Sensing circuitry 122 may also pass one or more digitized EGM signals to processing circuitry 120 for analysis, e.g., for use in cardiac rhythm discrimination”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bardy with the teachings of Iyer, with a reasonable expectation of success, by explicitly processing electrode leads signal along different circuitry to distinguish heart rhythms. This would have reduced the noise of any ventricle signal, increasing the accuracy of a heart arrythmia diagnosis.
Regarding claim 10, Bardy teaches all of the limitations of claim 7. Bardy does not explicitly teach, as taught by Iyer wherein the processing module is configured to synchronously process said first signal in said first processing channel and said second signal in said second processing channel. ([[0115] “Sensing circuitry 122 in IMD 15 as shown in FIG. 6 may monitor signals from a selected two or more of electrodes 132 in order to monitor electrical activity of heart, impedance, or some other electrical phenomenon.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bardy with the teachings of Iyer, with a reasonable expectation of success, by explicitly processing electrode signals from multiple electrodes simultaneously to distinguish heart rhythms. This would have increased the speed of processing cardiac signals, increasing the accuracy of a heart arrythmia diagnosis.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cao et al. (US20160144190) discloses an implantable medical device sensing device senses a P-wave attendant to an atrial depolarization of the heart via housing-based electrodes carried by the sensing device when the sensing device is implanted outside the cardiovascular system. This system discloses analog to digital processing, filtering, various signal processing channels, ventricle signaling, waveforms, and more.
Sommer et al. (US20160114151) discloses a multi lead cardiac system that creates differential signaling across one lead by measuring the voltage difference across two positional vectors. This system contains analog to digital converting, filtering, various channels for signal processing, and more.
Drake et al. (US20220023621)
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792