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 1, 6-8, and 22 are currently amended.
Claims 2 and 21 are cancelled.
Claim 23 is added as a new claim.
Response to Arguments
Applicant's arguments, pages 9-19, filed 2/17/2026, have been fully considered but they are not
persuasive.
35 U.S.C. 101: Step 2A Prong 1
Regarding claim 1, applicant argues that the features of the claims must be read in the context
of the claim and does not recite an abstract idea. Enfish LLC v. Microsoft Corp., 822 F 3d 1327 (Fed. Cir. 2016). Applicant argues the technology of measuring and analyzing medical systems to provide a physician with the data needed to diagnose and treat a patient, is not an abstract idea. The examiner respectfully disagrees and argues that the claims recite an improvement towards abstract idea and not the computer system itself. Furthermore, the examiner argues that the control system is recited as computer implementation to perform the abstract idea, specifically, “deriving a plurality of derived features,” using a combination of the steps recited in claim 1.
Regarding Applicant’s arguments with respect to Enfish, the examiner respectfully disagrees that Claims 1, 3-20, and 22 should be found patent eligible in view of Enfish.
The Claims at issue in Enfish were focused on a specific asserted improvement in methods of automatic lip synchronization and facial expression animation using computer-implemented rules. According to the court, the claimed process used a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of automatic lip synchronization and facial expression animation. By incorporating the specific features of the rules as claim limitations, these claims were found by the court to be limited to a specific process for automatic lip synchronization and facial expression animation using particular information and techniques.
However, none of Claims 1, 3-20, and 22 are directed to a specific process for automatic lip synchronization and facial expression animation using particular information and techniques as discussed in Enfish. Further, unlike the claims at issue in Enfish, Claims 1, 3-20, and 22 merely apply an abstract idea to a computer and do not either improve the performance of the computer itself or computer animation in any way.
35 U.S.C. 101: Step 2A Prong 2
Regarding claim 1, applicant argues that the claim, as a whole, integrates the abstract idea into a
practical application. The applicant also argues that the instant case is similar to Cardionet, LLC v. Infobionic, Inc., Case: 191149 (Fed. Cir. 2020) and Ex Part Allen (PTAB Appeal No. 2022-000886, March, 2023). The examiner respectfully disagrees and argues that the claim, as a whole, recites a generic data gathering device, which analyzes IECG data and provides a diagnosis. The catheter and electrodes are recited as extra-solution activity to perform the step of data gathering. The control system is recited at a high level generality, with no other specific computer structure or machine learning program, to perform the abstract idea of deriving a plurality of derived features. Therefore, this limitation is recited as computer implementation to perform the abstract idea. The display is recited as extra-solution activity to perform a diagnostic step with various dimensions and features, based on the analyzed data.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1, 3-20, and 22 are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
The Claims at issue in Cardionet were focused on a specific asserted improvement in methods for detecting atrial fibrillation and atrial flutter using computer-implemented rules (variability and relevance determination logics). According to the court, the claimed process used a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of automatic atrial fibrillation and atrial flutter detection. By incorporating the specific features of the rules as claim limitations, these claims were found by the court to be limited to a specific process for detecting atrial fibrillation and atrial flutter using computer-implemented rules.
However, none of Claims 1, 3-20, and 22 are directed to a specific process for detecting atrial fibrillation and atrial flutter using computer-implemented rules, particular information and techniques as discussed in Cardionet. Further, unlike the claims at issue in Cardionet, Claims 1, 3-20, and 22 merely apply an abstract idea to a computer and do not either improve the performance of the computer itself or atrial fibrillation detection in any way.
The Claims at issue in Ex Parte Allen were focused on a specific asserted improvement in generating a hierarchical container representation of the patient EMR based on its hierarchal structure using computer-implemented rules. According to the court, the claimed process used a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a hierarchical container representation of the patient EMR based on its hierarchal structure and a treatment plan based on received data. By incorporating the specific features of the rules as claim limitations, these claims were found by the court to be limited to a specific process for generating a hierarchical container representation of the patient EMR based on its hierarchal structure using computer-implemented rules.
However, none of Claims 1, 3-20, and 22 are directed to a specific process for generating a hierarchical container representation of the patient EMR based on its hierarchal structure using computer-implemented rules, particular information and techniques as discussed in Ex Parte Allen. Further, unlike the claims at issue in Ex Parte Allen, Claims 1, 3-20, and 22 merely apply an abstract idea to a computer and do not either improve the performance of the computer itself or patient EMR representation in any way.
35 U.S.C. 101: Step 2B
Regarding claim 1, applicant argues that the claimed subject matter is patent eligible, specifically
combining data from at least two locations and at least two features and marking these comparable. An inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces. BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016). The examiner respectfully disagrees and argues that the combination of additional elements (catheter, electrodes, control system, and display), as a whole, does not recite an inventive concept for reasons disclosed in Step 2A Prong 2. The examiner adds that the additional elements are not analyzed narrowly because the combination of additional elements, as a whole is recited too broadly. The examiner suggest amending the claims to provide specific computer structure and machine learning models.
Applicant's arguments, pages 19-21, filed 2/17/2026, have been fully considered and are
persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Weinkam.
35 U.S.C. 102 and 103:
Regarding independent claims 1 and 22, applicant argues that Gutbrod, alone or in combination
with the prior art, does not teach “wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range; and wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature.” The examiner respectfully argues that Gutbrod teaches “wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range (fig. 5; paragraph 80 and 96).” Various derived features may be outputted by the processing system 32, such processed output may include isochronal maps, activation time maps, phase maps, action potential duration (APD) maps, Hilbert transform diagrams, vector field maps, contour maps, reliability maps, electrograms, cardiac action potentials and the like. System 10 is configured to determine an activation recovery interval (ARI) at a plurality of locations within a cardiac chamber of interest. ARI for second rate pacing, activation time, and recovery time are all derived features. A display for the map is color coded to identify an intensity or scale of ARI for each chamber.
After further search and consideration, the examiner will now rely on Weinkam to teach “wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature (col. 50, lines 3-35; col. 53-54, lines 37-67 and 1-45).” The data processing device may take many forms and different functions or derivations. A graduated pattern can be employed to indicate various regions in the graphical representation corresponding to different regions of flow in the intra-cardiac cavity. The identified regions 525 may be identified by any suitable methods including the use of gray-scale patterns, different colors, different opacities, different intensities and different shapes. It is understood that other embodiments may employ other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature. For example, transducer-based data containing blood and tissue impedance information may be employed to determine regions 525 as shown in FIG. 5H.
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 processing and display systems of Gutbrod with the intensity representation and processing derivations from Weinkam for the benefit of providing a wide range of intra-cardiac information and employing other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature.
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 1-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 22 are recited as a method and system with instructions for performing operations of the device comprising:
groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region;
derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels;
derives data points of the plurality of derived features in intervals over the time length, the first and second derived features thereby each having a time dimension and a value dimension with a value range;
combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension;
wherein the anatomical dimension comprises the anatomical regions;
wherein the feature dimension comprises the plurality of derived features;
wherein the time dimension is the time dimension of the first and the second derived features;
wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is
evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 and 23 are directed to an method, claim 22 is directed to a system with instructions to perform the steps of the method and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1, 22, and 23 recite a method and system with instructions for performing operations of the device comprising:
groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region;
derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels;
derives data points of the plurality of derived features in intervals over the time length, the first and second derived features thereby each having a time dimension and a value dimension with a value range;
combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension;
wherein the anatomical dimension comprises the anatomical regions;
wherein the feature dimension comprises the plurality of derived features;
wherein the time dimension is the time dimension of the first and the second derived features;
wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1 and 22 recite an abstract idea of a mental process.
Claims 1 , 22, and 23 recite the abstract idea of a mental process. The limitations as drafted in
the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic processing system and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example:
”Groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region;” A physician may group electrical signals from different channels based on the stimulation at each anatomical region.
“Derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels;” A physician may derive features from the stimulation using equation and function at each anatomical region.
“Derives data points of the plurality of derived features in intervals over the time length, the first and second derived features thereby each having a time dimension and a value dimension with a value range;” A physician may derive data points using equations and functions, each having a time dimension and a value dimension with a value range.
“Combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension;” A physician may draw an anatomical map with featured time and intensity dimensions based on the plurality of derived features.
“Wherein the anatomical dimension comprises the anatomical regions;” An anatomical map may be drawn by a physician.
“Wherein the feature dimension comprises the plurality of derived features;” A plurality of derived featured may be drawn on this map.
“Wherein the time dimension is the time dimension of the first and the second derived features;” The time dimensions may be updated over time by a pen and paper.
“Wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range.” The intensity of the derived features map be shown using colors or numbers by a physician on the map.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1, 22, and 23 recite the additional elements of a “a control system”, “an intracardiac
electrogram”, “a catheter” and a “electrodes” which are being interpreted as a processor of a data gathering device.
“Wherein the intracardiac electrogram has been recorded via a catheter inserted into a human body and has a time length, wherein the catheter comprises multiple electrodes placed at different anatomical positions. Wherein multiple channels of the intracardiac electrogram have been recorded by the electrodes.” These are pre-solution activity limitation to the step of data gathering.
“wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space.” The display is recited as extra-solution activity to perform a diagnostic step with various dimensions and features, based on the analyzed data.
“wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature.” The control system is recited at a high level generality, with no other specific computer structure or machine learning program, to perform the abstract idea of deriving a plurality of derived features. Therefore, this limitation is recited as computer implementation to perform the abstract idea.
However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical
application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
The additional elements when considered individually and in combination are not enough to
qualify as significantly more than the abstract idea.
“Wherein the intracardiac electrogram has been recorded via a catheter inserted into a human body and has a time length, wherein the catheter comprises multiple electrodes placed at different anatomical positions. Wherein multiple channels of the intracardiac electrogram have been recorded by the electrodes.” These are pre-solution activity limitation to the step of data gathering.
“wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space.” The display is recited as extra-solution activity to perform a diagnostic step with various dimensions and features, based on the analyzed data.
“wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature.” The control system is recited at a high level generality, with no other specific computer structure or machine learning program, to perform the abstract idea of deriving a plurality of derived features. Therefore, this limitation is recited as computer implementation to perform the abstract idea.
As discussed above with respect to integration of the abstract idea into a practical application,
“a control system”, “an intracardiac electrogram”, “a catheter” and a “electrodes” which are being interpreted as a processor of a data gathering device as recited to perform the steps of:
groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region;
derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels;
derives data points of the plurality of derived features in intervals over the time length, the first and second derived features thereby each having a time dimension and a value dimension with a value range;
combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension;
wherein the anatomical dimension comprises the anatomical regions;
wherein the feature dimension comprises the plurality of derived features;
wherein the time dimension is the time dimension of the first and the second derived features;
wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range.
amount to no more than mere instructions to apply the exception using generic computer
components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Gutbrod et al. US Pub.: US 20180368713 A1, hereinafter Gutbrod) teaches a data gathering device with a processor and memory, and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
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 1-3, 7, 11, 16, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable
by Gutbrod et al. US Pub.: US 20180368713 A1, hereinafter Gutbrod in view of Weinkam et al. US Pat.: US 10327844 B2, hereinafter Weinkam.
Regarding claim 1, Gutbrod teaches a method for analyzing an intracardiac electrogram via a control system (fig. 1, control system 32; paragraph 7 and 78):
wherein the intracardiac electrogram has been recorded via a catheter inserted into a human body and has a time length (fig. 1, catheter 14; paragraph 75);
wherein the catheter comprises multiple electrodes placed at different anatomical positions (fig. 2, electrodes 24; paragraph 76);
wherein multiple channels of the intracardiac electrogram have been recorded by the electrodes (fig. 2; paragraph 76 and 109-110); As with the first electrogram signal, each second electrogram signal is related to the three-dimensional positional data corresponding to the plurality of anatomical locations for each of the electrodes 24.
wherein the control system groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region (fig. 2; paragraph 77); As the electrical wave propagates through the heart, a second group of electrodes 24 may sense the activation event of the electrical wave at times later than the first group of electrodes 24.
wherein the control system derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels (fig. 2; paragraph 80, 95, and 111); The system 10 is configured to determine an activation recovery interval (ARI) at a plurality of locations within a cardiac chamber of interest. ARI for second rate pacing, activation time, and recovery time are all derived features.
wherein the control system derives data points of the plurality of derived features in intervals over the time length, the first and second derived features thereby each having a time dimension and a value dimension with a value range (fig. 2; paragraph 111); The ARI calculation unit 404 determines an activation time and a recovery time for each corresponding anatomical location. The unit calculate each activation recovery interval based on a difference between the activation time and the recovery time for each corresponding anatomical location.
wherein the control system combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension, wherein the anatomical dimension comprises the anatomical regions (fig. 5; paragraph 95-96); The map of FIG. 5 is a color-coded three-dimensional ARI map for the chamber, providing a graphical illustration of the ARI associated with each location within the chamber for a given cardiac cycle.
wherein the feature dimension comprises the plurality of derived features (fig. 2; paragraph 95); ARI for second rate pacing, activation time, and recovery time are all derived features.
wherein the time dimension is the time dimension of the first and the second derived features (fig. 2; paragraph 112); A gradual change in ARI is disclosed.
wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range (fig. 5; paragraph 80 and 96).” Various derived features may be outputted by the processing system 32, such processed output may include isochronal maps, activation time maps, phase maps, action potential duration (APD) maps, Hilbert transform diagrams, vector field maps, contour maps, reliability maps, electrograms, cardiac action potentials and the like. System 10 is configured to determine an activation recovery interval (ARI) at a plurality of locations within a cardiac chamber of interest. ARI for second rate pacing, activation time, and recovery time are all derived features. A display for the map is color coded to identify an intensity or scale of ARI for each chamber.
However, Gutbrod does not teach wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space, and wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature.
Weinkam, in the same field of endeavor, teaches wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space, and wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature (col. 50, lines 3-35; col. 53-54, lines 37-67 and 1-45).” The data processing device may take many forms and different functions or derivations. A graduated pattern can be employed to indicate various regions in the graphical representation corresponding to different regions of flow in the intra-cardiac cavity. The identified regions 525 may be identified by any suitable methods including the use of gray-scale patterns, different colors, different opacities, different intensities and different shapes. It is understood that other embodiments may employ other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature. For example, transducer-based data containing blood and tissue impedance information may be employed to determine regions 525 as shown in FIG. 5H.
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 processing and display systems of Gutbrod with the intensity representation and processing derivations from Weinkam for the benefit of providing a wide range of intra-cardiac information and employing other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature.
Regarding claim 2, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space (fig. 5; paragraph 95-96); The map of FIG. 5 is a color-coded three-dimensional ARI map for the chamber, providing a graphical illustration of the ARI associated with each location within the chamber for a given cardiac cycle.
Regarding claim 3, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein the intervals are at least 0.5 seconds long and wherein the display of the control system displays at least 5 minutes of the time dimension (fig. 4-5; paragraph 95-96 and 103). Figure 4 shows a time display representation of ARI and APD. The time dimension may be presented based on user preference and is subjective.
Regarding claim 7, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein the control system visually groups the plurality of derived features along the feature dimension and displays the anatomical dimension of each feature as a visual group along the anatomical dimension (fig. 2; paragraph 77 and 118); As the electrical wave propagates through the heart, a second group of electrodes 24 may sense the activation event of the electrical wave at times later than the first group of electrodes 24.
Regarding claim 11, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein the control system continuously receives new data from a measurement system comprising at least the catheter and updates the feature space (paragraph 118). The repolarization mapping process are carried out continuously and repetitively over a succession of time steps that collectively define a larger time interval.
Regarding claim 16, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein the part of the time dimension according to which the transformation functions are updated changes with new intervals (paragraph 118). The repolarization mapping process are carried out continuously and repetitively over a succession of time steps that collectively define a larger time interval.
Regarding claim 20, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein at least one of the features of the feature dimension are chosen from the group consisting of dominant frequency, autocorrelation of the surface ECG, a cross correlation of the intracardiac electrogram, cycle length, local activation time dispersion, fractionation index, cycle length variation, and dominant frequency gradient (paragraph 101-102). A difference between ARIs for the regions provides an indication of the dispersion of the ARIs.
Regarding claim 21, Gutbrod in view of Weinkam teaches the claimed invention and Gutbrod
further teaches wherein the control system uses the feature space to derive at least one of a prognosis about the success of the ablation therapy, a proposal for a next step in the ablation therapy and a prognosis of the change of the feature space by a possible ablation step (paragraph 78-80). Activation patterns may have a role in the initiation and maintenance of atrial fibrillation, and ablation of the rotor path, rotor core, and/or divergent foci may be effective in terminating the atrial fibrillation.
Regarding claim 22, Gutbrod teaches a control system for analyzing an intracardiac electrogram:
wherein the intracardiac electrogram has been recorded via a catheter inserted into a human body and has a time length (fig. 1, catheter 14; paragraph 75);
wherein the catheter comprises multiple electrodes placed at different anatomical positions (fig. 2, electrodes 24; paragraph 76);
wherein multiple channels of the intracardiac electrogram have been recorded by the electrodes (fig. 2; paragraph 76 and 109-110); As with the first electrogram signal, each second electrogram signal is related to the three-dimensional positional data corresponding to the plurality of anatomical locations for each of the electrodes 24.
wherein the control system groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region (fig. 2; paragraph 77); As the electrical wave propagates through the heart, a second group of electrodes 24 may sense the activation event of the electrical wave at times later than the first group of electrodes 24.
wherein the control system derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels (fig. 2; paragraph 80, 95, and 111); The system 10 is configured to determine an activation recovery interval (ARI) at a plurality of locations within a cardiac chamber of interest. ARI for second rate pacing, activation time, and recovery time are all derived features.
wherein data points of the plurality of derived features are derived in intervals over the time length, the first and second features thereby each having a time dimension and a value dimension with a value range (fig. 2; paragraph 111); The ARI calculation unit 404 determines an activation time and a recovery time for each corresponding anatomical location. The unit calculate each activation recovery interval based on a difference between the activation time and the recovery time for each corresponding anatomical location.
wherein the control system combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension, wherein the anatomical dimension comprises the anatomical regions (fig. 5; paragraph 95-96); The map of FIG. 5 is a color-coded three-dimensional ARI map for the chamber, providing a graphical illustration of the ARI associated with each location within the chamber for a given cardiac cycle.
wherein the feature dimension comprises the plurality of derived features (fig. 2; paragraph 95); ARI for second rate pacing, activation time, and recovery time are all derived features.
wherein the time dimension is the time dimension of the first and the second derived features (fig. 2; paragraph 112); A gradual change in ARI is disclosed.
wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range (fig. 5; paragraph 96). The map is color coded to identify an intensity or scale of ARI for each chamber.
However, Gutbrod does not teach wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space, and, wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature.
Weinkam, in the same field of endeavor, teaches wherein the control system comprises a display that displays the anatomical dimension, the feature dimension, the time dimension and the intensity dimension of the feature space, and, wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature (col. 50, lines 3-35; col. 53-54, lines 37-67 and 1-45).” The data processing device may take many forms and different functions or derivations. A graduated pattern can be employed to indicate various regions in the graphical representation corresponding to different regions of flow in the intra-cardiac cavity. The identified regions 525 may be identified by any suitable methods including the use of gray-scale patterns, different colors, different opacities, different intensities and different shapes. It is understood that other embodiments may employ other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature. For example, transducer-based data containing blood and tissue impedance information may be employed to determine regions 525 as shown in FIG. 5H.
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 processing and display systems of Gutbrod with the intensity representation and processing derivations from Weinkam for the benefit of providing a wide range of intra-cardiac information and employing other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature.
Regarding claim 23, Gutbrod teaches a method for analyzing an intracardiac electrogram via a control system (fig. 1, control system 32; paragraph 7 and 78);
wherein the intracardiac electrogram has been recorded via a catheter inserted into a human body and has a time length (fig. 1, catheter 14; paragraph 75);
wherein the catheter comprises multiple electrodes placed at different anatomical positions (fig. 2, electrodes 24; paragraph 76);
wherein multiple channels of the intracardiac electrogram have been recorded by the electrodes (fig. 2; paragraph 76 and 109-110); As with the first electrogram signal, each second electrogram signal is related to the three-dimensional positional data corresponding to the plurality of anatomical locations for each of the electrodes 24.
wherein the control system groups the channels into at least a first group of channels comprising at least one channel assigned to a first anatomical region and a second group of channels comprising at least one channel assigned to a second anatomical region (fig. 2; paragraph 77); As the electrical wave propagates through the heart, a second group of electrodes 24 may sense the activation event of the electrical wave at times later than the first group of electrodes 24.
wherein the control system derives a plurality of derived features comprising a first derived feature relating to the first anatomical region and a different second derived feature relating to the first anatomical region from the first group of channels and derives the first derived feature and the second derived feature relating to a second anatomical region from the second group of channels (fig. 2; paragraph 80, 95, and 111); The system 10 is configured to determine an activation recovery interval (ARI) at a plurality of locations within a cardiac chamber of interest. ARI for second rate pacing, activation time, and recovery time are all derived features.
wherein the control system derives data points of the plurality of derived features in intervals over the time length, the first and second derived features thereby each having a time dimension and a value dimension with a value range (fig. 2; paragraph 111); The ARI calculation unit 404 determines an activation time and a recovery time for each corresponding anatomical location. The unit calculate each activation recovery interval based on a difference between the activation time and the recovery time for each corresponding anatomical location.
wherein the control system combines the plurality of derived features into a feature space comprising at least an anatomical dimension and a feature dimension and a time dimension and an intensity dimension, wherein the anatomical dimension comprises the anatomical regions (fig. 5; paragraph 95-96); The map of FIG. 5 is a color-coded three-dimensional ARI map for the chamber, providing a graphical illustration of the ARI associated with each location within the chamber for a given cardiac cycle.
wherein the feature dimension comprises the plurality of derived features (fig. 2; paragraph 95); ARI for second rate pacing, activation time, and recovery time are all derived features.
wherein the time dimension is the time dimension of the first and the second derived features (fig. 2; paragraph 112); A gradual change in ARI is disclosed.
wherein the intensity dimension comprises an intensity range and wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range (fig. 5; paragraph 96). The map is color coded to identify an intensity or scale of ARI for each chamber.
and wherein the control system transforms the value ranges of the derived features onto the intensity range via a different transformation function per feature (fig. 5; paragraph 80 and 96).” Various derived features may be outputted by the processing system 32, such processed output may include isochronal maps, activation time maps, phase maps, action potential duration (APD) maps, Hilbert transform diagrams, vector field maps, contour maps, reliability maps, electrograms, cardiac action potentials and the like. System 10 is configured to determine an activation recovery interval (ARI) at a plurality of locations within a cardiac chamber of interest. ARI for second rate pacing, activation time, and recovery time are all derived features. A display for the map is color coded to identify an intensity or scale of ARI for each chamber.
However, Gutbrod does not teach wherein the control system uses the feature space to derive at least one of a prognosis about the success of the ablation therapy, a proposal for a next step in the ablation therapy and a prognosis of the change of the feature space by a possible ablation step.
Weinkam, in the same field of endeavor, teaches wherein the control system uses the feature space to derive at least one of a prognosis about the success of the ablation therapy, a proposal for a next step in the ablation therapy and a prognosis of the change of the feature space by a possible ablation step (col. 50, lines 3-35; col. 53-54, lines 37-67 and 1-45).” The data processing device may take many forms and different functions or derivations. A graduated pattern can be employed to indicate various regions in the graphical representation corresponding to different regions of flow in the intra-cardiac cavity. The identified regions 525 may be identified by any suitable methods including the use of gray-scale patterns, different colors, different opacities, different intensities and different shapes. It is understood that other embodiments may employ other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature. For example, transducer-based data containing blood and tissue impedance information may be employed to determine regions 525 as shown in FIG. 5H.
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 processing and display systems of Gutbrod with the intensity representation and processing derivations from Weinkam for the benefit of providing a wide range of intra-cardiac information and employing other techniques to identify regions in the graphical representation corresponding to a desired anatomical feature.
Claims 4-5, 8-10, 12-13, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable
over Gutbrod in view of Weinkam in view of Saksena et al. US Pub.: US 20070232949 A1, hereinafter Saksena.
Regarding claim 4, Gutbrod teaches a display (fig. 4-5; paragraph 95-96 and 103).
However, Gutbrod in view of Weinkam does not explicitly teach wherein the display of the control system displays several rows of data along a common time axis, wherein the rows of data comprise a row for each of the plurality of derived features, wherein the rows comprise the data points of the respective feature along the time axis and mapped intensity values of the intensity range for the data points.
Saksena, in the same field of endeavor, teaches wherein the display of the control system displays several rows of data along a common time axis, wherein the rows of data comprise a row for each of the plurality of derived features, wherein the rows comprise the data points of the respective feature along the time axis and mapped intensity values of the intensity range for the data points (fig. 4; paragraph 33 and 40-42). Multiple rows of derived data is recorded along a time domain. Additionally, a mapped anatomical structure of the heart is shown with color coded intensity levels of electrical activity and an intensity scale.
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 display of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 5, Gutbrod in view of Weinkam in view of Saksena teaches the claimed
invention and Gutbrod further teaches wherein the intensity values are color coded (fig. 5; paragraph 96). The map is color coded to identify an intensity or scale of ARI for each chamber.
Regarding claim 8, Gutbrod teaches a display (fig. 4-5; paragraph 95-96 and 103).
However, Gutbrod in view of Weinkam does not explicitly teach wherein the control system further displays on the display at least one channel of a surface ECG and/or at least one channel of the intracardiac electrogram, and wherein the control system displays on the display a section of the at least one channel with a displayed time length shorter than the displayed time length of the time dimension of the feature space.
Saksena, in the same field of endeavor, teaches wherein the control system further displays on the display at least one channel of a surface ECG and/or at least one channel of the intracardiac electrogram, and wherein the control system displays on the display a section of the at least one channel with a displayed time length shorter than the displayed time length of the time dimension of the feature space (fig. 4; paragraph 33 and 40-42). The display comprise sectional displays for at least one channel or more with time dimension of the featured space.
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 display of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 9, Gutbrod teaches a display (fig. 4-5; paragraph 95-96 and 103).
However, Gutbrod in view of Weinkam does not explicitly teach wherein the data points of the plurality of derived features are calculated over time spans greater than the intervals.
Saksena, in the same field of endeavor, teaches wherein the data points of the plurality of derived features are calculated over time spans greater than the intervals (fig. 4; paragraph 40-42). The display comprise derived features calculated over time in intervals.
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 display of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 10, Gutbrod teaches a display (fig. 4-5; paragraph 95-96 and 103).
However, Gutbrod in view of Weinkam does not explicitly teach wherein the control system further derives at least one surface feature from the surface ECG, wherein the at least one surface feature has a time dimension and a value dimension, wherein the control system inserts the at least one surface feature into the feature space such that the feature dimension comprises the at least one surface feature, wherein the anatomical dimension comprises a global anatomical region, wherein the time dimension of the at least one surface feature is mapped onto the time dimension of the feature space, and wherein the control system transforms the value ranges of the value dimension of the at least one surface feature onto the intensity range.
Saksena, in the same field of endeavor, teaches wherein the control system further derives at least one surface feature from the surface ECG, wherein the at least one surface feature has a time dimension and a value dimension, wherein the control system inserts the at least one surface feature into the feature space such that the feature dimension comprises the at least one surface feature, wherein the anatomical dimension comprises a global anatomical region, wherein the time dimension of the at least one surface feature is mapped onto the time dimension of the feature space, and wherein the control system transforms the value ranges of the value dimension of the at least one surface feature onto the intensity range (fig. 4; paragraph 33 and 40-42). Multiple rows of derived data is recorded along a time domain. Additionally, a mapped anatomical structure of the heart is shown with color coded intensity levels of electrical activity and an intensity scale.
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 display of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 12, Gutbrod teaches a control system and display (fig. 4-5; paragraph 95-96 and
103).
However, Gutbrod in view of Weinkam does not explicitly teach wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range via a different transformation function per feature.
Saksena, in the same field of endeavor, teaches wherein the control system transforms the value ranges of the plurality of derived features onto the intensity range via a different transformation function per feature (fig. 4; paragraph 33 and 40-42). Multiple rows of derived features is recorded along a time domain. Additionally, a mapped anatomical structure of the heart is shown with color coded intensity levels of electrical activity and an intensity scale.
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 display and control method of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 13, Gutbrod in view of Weinkam in view of Saksena teaches the claimed
invention and Gutbrod further teaches wherein the transformation function is equal for all anatomical regions per feature (paragraph 102). Calculated ARIs are compared between anatomical regions of the heart to derive spatial estimates of the dispersion of ARIs as an indication of underlying disease.
Regarding claim 15, Gutbrod in view of Weinkam in view of Saksena teaches the claimed
invention and Gutbrod further teaches wherein the transformation functions are updated based on the value ranges of the respective feature or of all anatomical regions per feature over the time dimension or part of the time dimension (paragraph 118). The repolarization mapping process are carried out continuously and repetitively over a succession of time steps that collectively define a larger time interval.
Regarding claim 17, Gutbrod teaches a control system and display (fig. 4-5; paragraph 95-96 and
103).
Gutbrod in view of Weinkam does not explicitly teach wherein the control system adapts at least one of the transformation functions based on the value range of the respective feature or feature group, and based on predefined boundaries.
Saksena, in the same field of endeavor, teaches wherein the control system adapts at least one of the transformation functions based on the value range of the respective feature or feature group, and based on predefined boundaries (fig. 4; paragraph 33 and 40-42). Figure 4 permits high-resolution analysis of regions of interest in either chamber, featured group. The transformation function is adapted and changed because it correlates the electrical activity to the specific regions in the heart in electrogram timing.
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 display and control method of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 18, Gutbrod teaches a control system and display (fig. 4-5; paragraph 95-96 and
103).
Gutbrod in view of Weinkam does not explicitly teach wherein the control system adapts at least one of the transformation functions such that the transformation of the values of some data points of the respective feature depends on the values of data points located later in time.
Saksena, in the same field of endeavor, teaches wherein the control system adapts at least one of the transformation functions such that the transformation of the values of some data points of the respective feature depends on the values of data points located later in time (fig. 4; paragraph 33 and 40-42). The transformation function is adapted and changed because it correlates the electrical activity to the specific regions in the heart in electrogram timing. The timing is being adapted further in time during the diagnosis or mapping step.
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 display and control method of Gutbrod in view of Weinkam with the features shown in the display of Saksena for the benefit of providing sufficient information to allow a physician to identify all characteristics of the heart simultaneously because they were limited to sensing and displaying specific areas sequentially and did not enable simultaneous visualization of global electrical pattern.
Regarding claim 19, Gutbrod teaches wherein the first group and the second group each
comprise at least two channels (fig. 2; paragraph 76 and 109-110); As with the first electrogram signal, each second electrogram signal is related to the three-dimensional positional data corresponding to the plurality of anatomical locations for each of the electrodes 24.
However, Gutbrod in view of Weinkam does not teach wherein the control system combines all channels of every, group by calculating an average into a single data point per feature per time interval.
Saksena, in the same field of endeavor, teaches wherein the control system combines all channels of every, group by calculating an average into a single data point per feature per time interval (paragraph 40-42 and 47). This information can be used by the analyzer to reveal timing and average electrical activity.
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 control method of Gutbrod in view of Weinkam with the averaging step of Saksena for the benefit of providing a reference electrode information, which can be selected for activation map timing.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gutbrod in view of
Weinkam in view of Haeusser et al. US Pub.: US 20200245885 A1, hereinafter Haeusser.
Regarding claim 6, Gutbrod teaches a control system (fig. 1, control system 32; paragraph 7 and
78).
However, Gutbrod in view of Weinkam does not explicitly teach wherein the control system low pass filters the intensity values of the plurality of derived features along the time dimension and displays the low passed derived features.
Haeusser, in the same field of endeavor, teaches wherein the control system low pass filters the intensity values of the plurality of derived features along the time dimension and displays the low passed derived features (fig. 1; paragraph 67).
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 control system of Gutbrod in view of Weinkam to add the low-pass filter from Haeusser for the benefit of increasing the accuracy of processing and analysis.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gutbrod in view of
Weinkam in view of Saksena in view of Haeusser.
Regarding claim 14, Gutbrod in view of Weinkam in view of Saksena does not explicitly teach
wherein at least one of the transformation functions is non-linear.
Haeusser, in the same field of endeavor, teaches wherein at least one of the transformation functions is non-linear (paragraph 123 and 138). The amplitudes of individual filtered electrogram signals are normalized with respect to a given standard deviation, which is a non-linear function.
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 control method of Gutbrod in view of Weinkam in view of Saksena with the non-linear function from Haeusser for the benefit of normalizing or adjusting the amplitudes of the various traces or electrograms.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN (email: Thien.Tran1@uspto.gov) whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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