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 .
Status of Claims
Claims 41-46, 48-56, and 58-62 are rejected. Claims 1-40, 47, and 57 are canceled.
Response to Arguments
Claim Rejections - 35 USC § 112
The previous 112(a) rejection of claims 50 and 60 has been withdrawn in view of the amendment.
The previous 112(b) rejections have been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 3/11/26 have been fully considered but they are not persuasive.
Applicant asserts that the recited operations—computing standard deviations of electrode position signals over a time interval for multiple electrodes and comparing them to a threshold—are inherently computational operations performed on real-time sensor data streams during a live intracardiac catheter procedure. However, the claims do not recite performing the steps in real-time. Even if they did, MPEP 2106.05 (f) states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Applicant further asserts that standard deviation computation requires summing squared differences from a mean across a data set—a mathematical operation on a series of measured position values that is tied to physical signals from electrodes inside a patient’s heart. This is not the type of simple observation, evaluation, or judgement that can practically be performed in the human mind. However, the claims do not specify the time frame these computations need to be performed in as well as the size of the data sets. Therefore, standard deviation can be performed using pen and paper.
Applicant asserts that Applicant’s claims are analogous to claim 2 of Example 37 of the USPTO’s Subject Matter Eligibility Example, which was found not to recite an abstract idea at Prong 1. In Example 37, the claim did not recite a mental process, because tracking memory allocation cannot practically be performed in the human mind. Applicant asserts that similarly, computing standard deviations of impedance-based position signals from dozens of electrodes over 150 sample points in 2.5 seconds cannot be performed in the human mind. However, the Examiner disagrees. The claims do not recite “computing standard deviations of impedance-based position signals from dozens of electrodes over 150 sample points in 2.5 seconds.” Therefore, standard deviation can be performed using pen and paper.
Applicant asserts that the specification identifies a specific technical problem, which is to improve the quality of electrophysiological (EP) mapping by eliminating ECG signals acquired by electrodes whose positioning stability is insufficient and reduce the duration of EP mapping procedures.
Applicant additionally asserts that the claims reflect the improvement. However, the alleged improvement is directed to the abstract idea itself. An improvement to the abstract idea is still an abstract idea.
Applicant asserts that the claims are analogous to eligible claims in the USPTO’s Guidance. Applicant cites to Claim 1 of Example 40, where it recited collecting network traffic data through a network appliance, comparing the data to a threshold, and collecting additional NetFlow protocol data when the threshold is exceeded. There was a practical application based on the improvement to network monitoring technology. Applicant asserts that this is similar to the instant application, because the amended claims do not merely compare data to a threshold; they use the threshold comparison to selectively gate which electrode signals are analyzed for AF. However, the Examiner disagrees. This would not result in a practical application, because a threshold comparison and selecting signals to be analyzed for AF are directed to the abstract idea. An improvement to the abstract idea is still an abstract idea.
Applicant asserts that the claims are analogous to claims found eligible under Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), where the Federal Circuit held that a specific configuration of inertial sensors combined with a specific method of using the signals from those sensors was not directed to an abstract idea. Applicant states similarly, the claims recite a specific configuration of catheter electrodes combined with a specific method of processing position signals (SD computation and threshold comparison) to selectively gate which ECG signals undergo AF analysis—a specific improvement that increase the accuracy of cardiac EP maps. However, the Examiner disagrees.
In Thales, the sensors were used in a non-conventional way. Here, a catheter having a plurality of electrodes is being used in a conventional way. As shown in the 101 rejection below, a catheter having a plurality of electrodes amounts to data gathering and is a well-understood, routine, and conventional structure.
Applicant asserts that the analysis ignores the claims’ integrated process of computing position-signal SDs, comparing them to a threshold, and selectively gating AF analysis based on the result. However, the Examiner disagrees. These are not additional elements. Rather, as indicated in the rejection below, they are steps directed to the abstract idea.
Applicant cites to claim 3, Example 47 in the USPTO Guidance, where the claim provides for improved network security using the information from the detection to enhance security by taking proactive measures to remediate the danger by detecting the source address associated with the potentially malicious packets. Applicant asserts that the instant application is similar, because the claims automatically filter out unreliable electrode data before it contaminates the AF analysis. However, the Examiner disagrees. Filtering data is directed to the abstract idea. That is nothing more than a medical professional using pen and paper to cross out outliers in the data set.
Applicant asserts that the specific ordered combination is not well-understood, routine, or conventional. However, the Examiner cites Applicant to MPEP 2106.05, which states:
As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
Claim Rejections - 35 USC § 103
Applicant's arguments filed 3/11/26 have been fully considered but they are not persuasive.
Applicant states that the Examiner’s rejection of former claims 47 and 57 confirms that Rosenberg and Urman do not teach the specific SD-based stability determination now recited in the independent claims. The Examiner agrees.
Applicant further asserts that Angel falls short of disclosing this subject matter, because Angel computes SD of phase values, not SD of position values. However, the Examiner disagrees. ¶148 of Angel indicates that:
each electrode 12a can be associated with a magnitude and phase (i.e. the angle in the complex plane subtended by the real and imaginary components of a localization voltage measurement) related to a localization potential on each of the three localization axes.
¶148 of Angel further indicates that:
from each electrode 12a’s phase values, the mean and standard deviation can be computed.
Based on the above citations, a phase is based on a localization voltage measurement, which is related to a localization potential on each of the three localization axes. ¶53 of Angel states:
localization describes the process of establishing a coordinate system, and using one or more signals, such as electronic signals, to determine the position of one or more objects within that system.
Therefore, since a phase is related to localization, it relates to a position.
Second, Applicant asserts that Angel’s non-functional electrode detection is a hardware quality check that occurs before any clinical analysis, while Applicant’s positioning stability determination is an integrated step within the EP mapping workflow that gates which electrode data proceeds to AF determination. However, Angel was never relied upon for AF determination. Angel was only relied upon for the specifics of wherein determining the positioning stability comprises, for each of the electrodes: (i) determining, using the position signals received along the predefined time interval, a standard deviation (SD) of a position of the electrode and (ii) comparing the determined SD to a given threshold.
Third, Applicant asserts that Angel never connects its non-functional electrode detection to any determination of whether ECG signals are indicative of atrial fibrillation. However, Angel was never indicated as being relied upon to teach that feature. Instead, primary reference Rosenberg was relied upon to teach the determination of whether ECG signals are indicative of atrial fibrillation. Angel was only relied upon for the specifics of wherein determining the positioning stability comprises, for each of the electrodes: (i) determining, using the position signals received along the predefined time interval, a standard deviation (SD) of a position of the electrode and (ii) comparing the determined SD to a given threshold.
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 41-46, 48-56, and 58-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 41-46, 48-56, and 58-62 are directed to statutory subject matter as the claims recite a method and a system for improving electrophysiological (EP) mapping of a heart by identifying electrocardiogram (ECG) signals indicative of atrial fibrillation (AF).
Step 2A, Prong One
Regarding claims 41 and 51, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 41 and 51, the limitations of “determining, for each of the electrodes based on the position signals, a positioning stability along the predefined time interval, wherein determining the positioning stability comprises, for each of the electrodes: (i) determining, using the position signals received along the predefined time interval, a standard deviation (SD) of a position of the electrode, and (ii) comparing the determined SD to a given threshold; and for only the electrodes whose positioning stability has an error smaller than a given threshold, determining whether the ECG signals are indicative of an atrial fibrillation (AF) in the heart” are a process, as drafted, covers performance of the limitations that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving print outs of the position signals to determine a positioning stability, where the positioning stability is determined based on determining a standard deviation, and comparing the positioning stability to a threshold to determine whether the ECG signals are indicative of an atrial fibrillation (AF) in the heart.
Step 2A, Prong Two
For claims 41 and 51, the judicial exception is not integrated into a practical application. In particular, claims 41 and 51 recite “a catheter having a plurality of electrodes, the receiving step, a memory, which is configured to store the ECG signals that are indicative of the AF, and a processor.” The catheter having a plurality of electrodes and the receiving step amount to nothing more than pre-solution activity of data gathering. The processor and memory are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into 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 integration of the abstract idea into
a practical application, the additional elements of a processor and memory amount to nothing more than parts of a generic computer and a catheter having a plurality of electrodes amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, a catheter having a plurality of electrodes is a well-understood, routine, and conventional structure as evidenced by: US 20150133759 (¶26-a conventional method for mapping electropotentials of the heart, i.e., measuring intra-cardiac ECG signals, involves inserting a catheter with electrodes into the heart, and measuring potentials as the electrodes are moved to different locations within the heart), US 20150313501 (¶36-a conventional intracardial ECG signal path from a pair of ECG electrodes 10, 12 disposed on or in a cardiac catheter), and US 20180368716 (¶38-a conventional method for mapping electropotentials of the heart, i.e., measuring intracardiac ECG signals, involves inserting a catheter with electrodes into the heart, and measuring potentials as the electrodes are moved to different locations within the heart). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 42-46, 48-50, 52-56, and 58-62, the limitations of claims 41 and 51 further define the limitations already indicated as being directed to the abstract idea.
Claims 42 and 52 further define the processor being configured to store in the memory, which is nothing more than post-solution activity and parts of a generic computer.
Claims 43 and 53 further define a display, which is nothing more than post-solution activity and a part of a generic computer.
Claims 44-45 and 54-55 further define the displaying which is post-solution activity and the abstract idea. The limitations of “(a) assigning: (i) a first graphic representation to the first set of ECG signals and to the first attribute, and (ii) a second graphic representation to the second set of ECG signals and to the second attribute” are a process, as drafted, covers performance of the limitations that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional assigning graphic representations to the respective set of ECG signals.
Claims 46 and 56 further define the processor being configured to store in the memory, which is nothing more than post-solution activity and parts of a generic computer.
Claims 48 and 58 further define the data gathering and abstract idea.
Claims 49 and 59 further define the data gathering and the abstract idea. The receiving step amounts to pre-solution activity of data gathering. The storing step amounts to post-solution activity. The limitations of “(a) receiving of position signals and ECG signals from each of the plurality of electrodes during another predefined time interval, (b) determining the positioning stability, along the another predefined time interval, for each of the plurality of electrodes, (c) determining, for the electrodes whose positioning stability has an error smaller than the given threshold, whether the ECG signals are indicative of the AF” are a process, as drafted, covers performance of the limitations that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving print outs of the position signals to determine a positioning stability and comparing the positioning stability to a threshold to determine whether the ECG signals are indicative of an atrial fibrillation (AF) in the heart.
Claims 50 and 60 further define the data gathering and abstract idea.
Regarding claim 61, the receiving step amounts to data gathering as indicated above for claim 41. The limitations of “determining a number of the electrodes whose positioning stability has an error smaller than the given threshold; comparing the number to a predefined minimum electrode count; and in response to the number being less than the predefined minimum electrode count, repeating the receiving and determining steps during a new time interval” are a process, as drafted, covers performance of the limitations that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to determine a number of the electrodes whose positioning stability has an error smaller than the given threshold, compare the number to a predefined minimum electrode count, and in response to the number being less than the predefined minimum electrode count, repeating the receiving and determining steps during a new time interval.
Regarding claim 62, the limitations of “wherein determining the standard deviation (SD) of the position of the electrode comprises: determining, for each of the electrodes, an average position based on the position signals received along the predefined time interval; and computing the standard deviation of the position of the electrode relative to the average position” are a process, as drafted, covers performance of the limitations that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to determine, for each of the electrodes, an average position based on the position signals received along the predefined time interval, and computing the standard deviation of the position of the electrode relative to the average position.
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 41-45 and 51-55 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (US 20110066202 filed on 9/17/09) in view of Urman (US 20170202470 filed on 1/12/17 as cited in the IDS) and Angel (WO 2017192775 filed on 5/3/17).
Regarding claim 41 and 51, Rosenberg teaches a method and a system for improving electrophysiological (EP) mapping of a heart by identifying electrocardiogram (ECG) signals indicative of atrial fibrillation (AF) using stable electrodes of a catheter-based system, comprising: inserting, into a heart of a patient, a catheter having a plurality of electrodes configured for contact with tissue of the heart (¶95-electrodes may be associated with a catheter; ¶97-electrodes 532 , 532 ′, which may be part of a standard EP catheter 530); a processor (¶156-one or more processors), which is configured to: receive during a predefined time interval, for each electrode of a catheter having a plurality of electrodes located in a heart of a patient (¶95-electrodes may be associated with a catheter; ¶151- fiducials may be used during acquisition of information, for position determinations, or stability metric calculations. For example, a fiducial may be one or more discrete times or time intervals; ¶97; ¶175), (i) position signals indicative of a position of the respective electrode (¶90-in various examples, simultaneous to the position recording, an intracardiac electrogram (IEGM) from each electrode can also be recorded and associated with the anatomic position of the electrode; ¶77-for acquisition of electrical information and position information); determine, for each of the electrodes based on the position signals, a positioning stability along the predefined time interval (¶119-with respect to standard deviation, such a statistical measure may be applied to various forms of position information; ¶122-123; Fig. 10); and determine, for only the electrodes whose positioning stability has an error smaller than a given threshold (¶123-a criterion may exist that prohibits use of an electrode having a stability index below a threshold value; Fig. 10), whether the ECG signals are indicative of an atrial fibrillation (AF) in the heart (¶123-such a threshold may assist a clinician in site selection for an electrode or in programming an implantable device for sensing cardiac electrical activity and/or delivering electrical energy to the heart 102…prohibit use of the electrodes 1030 - 5 , 6 , 7 and 9 from sensing for the particular purpose of adjusting the pacing parameter; ¶59-similar rules can be applied to the atrial channel to determine if there is an atrial tachyarrhythmia or atrial fibrillation with appropriate classification and intervention; Fig. 10); and a memory (¶47-memory), which is configured to store the ECG signals that are indicative of the AF (¶60-store the digital signals for later processing; ¶84-storage of conclusions and/or data; ¶59-atrial fibrillation). While Rosenberg teaches a EP catheter and electrocardiogram (ECG) (¶97), Rosenberg does not explicitly teach (ii) electrocardiogram (ECG) signals acquired by the respective electrode (¶33-catheter 202 includes an array of catheter sensors (e.g., electrodes) each configured to detect electrical activity (electrical signals) of an area of the heart over time. When an IC ECG is performed, each electrode detects the electrical activity of an area of the heart in contact with the electrode); and wherein determining the positioning stability comprises, for each of the electrodes: (i) determining, using the position signals received along the predefined time interval, a standard deviation (SD) of a position of the electrode, and (ii) comparing the determined SD to a given threshold.
Urman relates to the field of medical diagnosis and treatment, particularly as it pertains to atrial fibrillation (¶2). Urman further teaches the invention using the following step:
(ii) electrocardiogram (ECG) signals acquired by the respective electrode (¶33-catheter 202 includes an array of catheter sensors (e.g., electrodes) each configured to detect electrical activity (electrical signals) of an area of the heart over time. When an IC ECG is performed, each electrode detects the electrical activity of an area of the heart in contact with the electrode; ¶48).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include (ii) electrocardiogram (ECG) signals acquired by the respective electrode of Urman in order to determine regions of interest to be ablated for treatment of cardiac arrhythmia, such as atrial fibrillation (Urman, ¶2).
Angel is generally related to systems and methods that may be useful for the diagnosis and treatment of cardiac arrhythmias or other abnormalities, in particular, the present invention is related to systems, devices, and methods useful in displaying cardiac activities associated with diagnosing and treating such arrhythmias or other abnormalities (¶13). Angel further teaches the invention using the following steps:
wherein determining the positioning stability comprises, for each of the electrodes: (i) determining, using the position signals received along the predefined time interval, a standard deviation (SD) of a position of the electrode (¶148-from each electrode 12a’s phase values, the mean and standard deviation can be computed), and (ii) comparing the determined SD to a given threshold (¶148-electrodes 12a which exhibit a phase above a threshold, such as a phase different from the mean by more than a constant multiplied by the standard deviation, are identified as non-functional and loaded into the non-functional electrode list associated with the current frame).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include wherein determining the positioning stability comprises, for each of the electrodes: (i) determining, using the position signals received along the predefined time interval, a standard deviation (SD) of a position of the electrode, and (ii) comparing the determined SD to a given threshold of Angel in order to diagnose and treat cardiac arrhythmias or other abnormalities (Angel, ¶13).
Regarding claims 42 and 52, the combination of Rosenberg, Urman, and Angel teaches the method and system of claims 41 and 51, wherein storing the ECG signals that are indicative of the AF (Urman, ¶82), comprises storing: (i) a first set of the ECG signals determined in a first attribute indicative of the AF (Urman, ¶48-determine one or more factors or parameters which may contribute to AF, morphological aspects of the IC ECG including RS-ratio 320, determine R-S complex information (e.g., ratio of R wave to S wave) at block 320; Fig. 3B), and (ii) a second set of the ECG signals, different from the first set, which is determined in a second attribute indicative of the AF, wherein the second attribute is different from the first attribute (Urman, ¶48-determine one or more factors or parameters which may contribute to AF, morphological aspects of the IC ECG including fractionation 322 (e.g., fractionated electrograms), information obtained by fractionation (e.g., slope information, information indicating an incidence of source behavior presented as the earliest activation from one of a plurality of electrodes, such as showing a percentage that the associated electrode was activated earlier than neighbouring electrodes) of the IC ECG signals at block 322; Fig. 3B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include wherein storing the ECG signals that are indicative of the AF, comprises storing: (i) a first set of the ECG signals determined in a first attribute indicative of the AF, and (ii) a second set of the ECG signals, different from the first set, which is determined in a second attribute indicative of the AF, wherein the second attribute is different from the first attribute of Urman in order to determine regions of interest to be ablated for treatment of cardiac arrhythmia, such as atrial fibrillation (Urman, ¶2).
Regarding claims 43 and 53, the combination of Rosenberg, Urman, and Angel teaches the method and system of claims 42 and 52, further comprising displaying the stored ECG signals on one or more maps of the heart (Urman, ¶34-the detected IC ECG signals and the detected extra-cardiac signals are processed (e.g., recorded over time, filtered, fractionated, mapped, combined, interpolated, etc.) by processing device 204 and displayed on display device 206).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include displaying the stored ECG signals on one or more maps of the heart of Urman in order to determine regions of interest to be ablated for treatment of cardiac arrhythmia, such as atrial fibrillation (Urman, ¶2).
Regarding claims 44 and 54, the combination of Rosenberg, Urman, and Angel teaches the method and system of claims 43 and 53, wherein displaying the stored ECG signals on one map of the heart (Urman, ¶34-the detected IC ECG signals and the detected extra-cardiac signals are processed (e.g., recorded over time, filtered, fractionated, mapped, combined, interpolated, etc. by processing device 204 and displayed on display device 206; ¶49-a perpetuator map 330 is generated from the CV Block information 326 and the fractionation information 322) comprises: (a) assigning: (i) a first graphic representation to the first set of ECG signals and to the first attribute (Urman, ¶11-displaying, on a display device, the R-S map; ¶49; ¶70), and (ii) a second graphic representation to the second set of ECG signals and to the second attribute (Urman, ¶52-fraction maps 340; ¶49), and (b) displaying one or both of: (i) the first set and the second set, and (ii) the first attribute and the second attribute, on the one map of the heart (Urman, ¶24-mapping techniques also include utilizing the various parameters of the acquired IC ECG signals and detected local activation times to provide mapping (e.g., activation/wave maps, CV maps, fractionation maps, voltage maps and block maps) which potentially represents the spatio-temporal manifestation of the AF process; ¶49-the combined driver/perpetuator map 334 may then be used (e.g., interpolated as part of an exemplary map interpolation layer) to determine one or more ablation ROIs 350; ¶54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include wherein displaying the stored ECG signals on one map of the heart comprises:(a) assigning: (i) a first graphic representation to the first set of ECG signals and to the first attribute, and (ii) a second graphic representation to the second set of ECG signals and to the second attribute, and(b) displaying one or both of: (i) the first set and the second set, and (ii) the first attribute and the second attribute, on the one map of the heart of Urman in order to determine regions of interest to be ablated for treatment of cardiac arrhythmia, such as atrial fibrillation (Urman, ¶2).
Regarding claims 45 and 55, the combination of Rosenberg, Urman, and Angel teaches the method and system of claims 43 and 53, wherein displaying the stored ECG signals on multiple maps (Urman, ¶34-the detected IC ECG signals and the detected extra-cardiac signals are processed (e.g., recorded over time, filtered, fractionated, mapped, combined, interpolated, etc.) by processing device 204 and displayed on display device 206) comprises: (a) assigning: (i) a first graphic representation to the first set of ECG signals and to the first attribute (Urman, ¶11-displaying, on a display device, the R-S map; ¶70), and (ii) a second graphic representation to the second set of ECG signals and to the second attribute (Urman, ¶52-fraction maps 340), and (b) displaying: (i) one or both of the first set and the first attribute on a first map of the heart, and (ii) one or both of the second set and the second attribute on a second map of the heart, different from the first map (Urman, ¶24-mapping techniques also include utilizing the various parameters of the acquired IC ECG signals and detected local activation times to provide mapping (e.g., activation/wave maps, CV maps, fractionation maps, voltage maps and block maps) which potentially represents the spatio-temporal manifestation of the AF process; ¶54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include wherein displaying the stored ECG signals on multiple maps comprises: (a) assigning: (i) a first graphic representation to the first set of ECG signals and to the first attribute, and (ii) a second graphic representation to the second set of ECG signals and to the second attribute, and (b) displaying: (i) one or both of the first set and the first attribute on a first map of the heart, and (ii) one or both of the second set and the second attribute on a second map of the heart, different from the first map of Urman in order to determine regions of interest to be ablated for treatment of cardiac arrhythmia, such as atrial fibrillation (Urman, ¶2).
Claims 46 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Urman and Angel as applied to claims 41, 42, 51, and 52 above, and further in view of Zeidan (US 20200060567 filed on 8/22/18).
Regarding claims 46 and 56, the combination of Rosenberg, Urman, and Angel teaches the method and system of claims 42 and 52, wherein the first attribute comprises a focal point (Urman, ¶8-identifying focal sources). However, the combination of Rosenberg, Urman, and Angel does not teach wherein the second attribute comprises a gradient of an atrial fibrillation cycle length (ACLV).
Zeidan teaches wherein the second attribute comprises a gradient of an atrial fibrillation cycle length (ACLV) (¶6- gradients between pairs of the average AFCL values are calculated for a plurality of average AFCL values).
Zeidan relates to intrabody electrophysiological mapping using probes, and particularly to cardiac electro-anatomical mapping (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include wherein the second attribute comprises a gradient of an atrial fibrillation cycle length (ACLV) of Zeidan in order to determine if the average AFCL values are indicative of regular AF activity (Zeidan, ¶6).
Claims 48-50 and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg in view of Urman and Angel as applied to claims 41 and 51 above, and further in view of Shmayahu (US 20190365280 filed on 1/17/18).
Regarding claims 48 and 58, the combination of Rosenberg, Urman, and Angel teaches the method and system of claims 41 and 51. However, the combination of Rosenberg, Urman, and Angel does not teach wherein the predefined time interval comprises selecting a duration of the predefined time interval between 1 second and 10 seconds.
Shmayahu teaches wherein the predefined time interval comprises selecting a duration of the predefined time interval between 1 second and 10 seconds (Shmayahu, ¶199-measurement repetition is frequent and automatic from stationary electrodes; for example, every 1 sec, 2 sec, or at another interval).
Shmayahu relates to the field of navigation of body cavities by intra-body probes, and/or to reconstruction of body cavity shape from measurements by intra-body probes (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rosenberg to include wherein the predefined time interval comprises selecting a duration of the predefined time interval between 1 second and 10 seconds of Shmayahu in order to examine for changes from the baseline measurement (Shmayahu, ¶199).
Regarding claims 49 and 59, the combination of Rosenberg, Urman, Angel, and Shmayahu teaches the method and system of claims 48 and 58, further comprising moving the plurality of electrodes to another location in the heart and repeating (Rosenberg, ¶107-such a technique may be repeated; ¶97-repositioning of the catheter allows for plotting of cardiac electrograms from other locations) the: (a) receiving of position signals (Rosenberg, ¶90-in various examples, simultaneous to the position recording, an intracardiac electrogram (IEGM) from each electrode can also be recorded and associated with the anatomic position of the electrode; ¶77-for acquisition of electrical information and position information) from each of the plurality of electrodes during another predefined time interval, and ECG signals from each of the plurality of electrodes during another predefined time interval (Urman, ¶33-catheter 202 includes an array of catheter sensors (e.g., electrodes) each configured to detect electrical activity (electrical signals) of an area of the heart over time. When an IC ECG is performed, each electrode detects the electrical activity of an area of the heart in contact with the electrode; ¶48), (b) determining the positioning stability, along the another predefined time interval, for each of the plurality of electrodes (Rosenberg, ¶119-with respect to standard deviation, such a statistical measure may be applied to various forms of position information; ¶122-123; Fig. 10); and determine, for only the electrodes whose positioning stability has an error smaller than the given threshold (Rosenberg, ¶123-a criterion may exist that prohibits use of an electrode having a stability index below a threshold value; Fig. 10), (c) determining, for the electrodes whose positioning stability has an error smaller than a given threshold (Rosenberg, ¶123-a criterion may exist that prohibits use of an electrode having a stability index below a threshold value; Fig. 10), whether the ECG signals are indicative of the AF (Rosenberg, ¶123-such a threshold may assist a clinician in site selection for an electrode or in programming an implantable device for sensing cardiac electrical activity and/or delivering electrical energy to the heart 102…prohibit use of the electrodes 1030 - 5 , 6 , 7 and 9 from sensing for the particular purpose of adjusting the pacing parameter; ¶59-similar rules can be applied to the atrial channel to determine if there is an atrial tachyarrhythmia or atrial fibrillation with appropriate classification and intervention; Fig. 10), and (d) storing the ECG signals that are indicative of the AF (Rosenberg, ¶60-store the digital signals for later processing; ¶84-storage of conclusions and/or data; ¶59-atrial fibrillation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the invention of Rosenberg to include ECG signals from each of the plurality of electrodes during another predefined time interval of Urman in order to determine regions of interest to be ablated for treatment of cardiac arrhythmia, such as atrial fibrillation (Urman, ¶2).
Regarding claims 50 and 60, the combination of Rosenberg, Urman, Angel, and Shmayahu teaches the method and system of claims 49 and 59, wherein the predefined time interval and the another predefined time interval are of an equal duration (Shmayahu, ¶199-measurement repetition is frequent and automatic from stationary electrodes; for example, every 1 sec, 2 sec, or at another interval).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rosenberg to include wherein the predefined time interval and another predefined time interval are of a substantially equal duration of Shmayahu in order to examine for changes from the baseline measurement (Shmayahu, ¶199).
Examiner’s Note
Claims 61-62 distinguish over the prior art and are objected to as being dependent upon a rejected base claim, but are still rejected under 35 USC § 101.
The following is a statement of reasons for the indication of distinguishing over the prior art:
The scope of determining a number of the electrodes whose positioning stability has an error smaller than the given threshold; comparing the number to a predefined minimum electrode count; and in response to the number being less than the predefined minimum electrode count, repeating the receiving and determining steps during a new time interval were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 20110066202; however it fails to recite comparing the number to a predefined minimum electrode count; and in response to the number being less than the predefined minimum electrode count, repeating the receiving and determining steps during a new time interval.
The scope of wherein determining the standard deviation (SD) of the position of the electrode comprises: determining, for each of the electrodes, an average position based on the position signals received along the predefined time interval; and computing the standard deviation of the position of the electrode relative to the average position were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is WO 2017192775; however it fails to recite wherein determining the standard deviation (SD) of the position of the electrode comprises: determining, for each of the electrodes, an average position based on the position signals received along the predefined time interval; and computing the standard deviation of the position of the electrode relative to the average position.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792