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
The amendments and remarks filed on 11DEC2025 have been entered and considered.
Claims 1, 2, 4, 8, 10-13, 15, 19, & 21-22 are currently pending.
Claims 1-2, 4, 12-13, & 15, have been amended.
New matter has been added. Support for freehand drawn inputs is found on Page 5 Line 18 of the Specification. No support for the input being independent of Ep measurements can be found in the disclosure.
No claims have been withdrawn, canceled, or added.
Claims 1, 2, 4, 8, 11-13, 15, 19, & 22 are under examination.
Response to Arguments
Applicant's arguments filed 11DEC2025 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 8 of the Remarks):
“Stewart, on the other hand, describes a cardiac mapping visualization tool that generates an electroanatomical map and associated annotation histograms or activation waveforms from already-acquired electrical signals and their locations. See Stewart at " [0006]-[0007]. A user may position a circular "virtual probe" (flashlight tool) on the map or adjust selection parameters, and the system displays a regional activation waveform or histogram for the selected points. See id. at " [0163]-[0168]. Stewart also teaches that when a user manually corrects a particular annotation on a single EGM, that correction may be automatically propagated to similar neighboring EGMs. See id. at IT [0092], [0110]. Stewart nowhere teaches allowing the user to freehand-draw anything on the EP map itself, let alone a directional activation path or a scar circle. The only high-level/map-level inputs are positioning a pre-defined circular probe or adjusting its radius. See Stewart at IT [0163]-[0168].”
The examiner disagrees as Stewart has been cited to perform these steps in (Stewart ¶0152 “The user input device used to make the selection may include a mouse, a touchscreen and/or the like, that is used to manipulate a selection tool that is provided on the GUI 632 provided by the display device. The selection tool may include, for example, a brush, a cursor for enclosing the selected region by drawing a freeform shape around the region, an expandable polygon selection tool, a virtual probe 682, and/or the like, and may be, in embodiments, selected from a number of optional selection tools.”), where “The user input device used to make the selection “ and “drawing a freeform shape around the region,” explicitly shows that a user may make a freehand input on the provided map, which can be put over any area of interest such as circling a scar. Therefore, the examiner is maintaining the prior art rejections. The remainder of this argument provides only general allegations regarding the state of Stewart’s invention based on a limited selection from the disclosure of Stewart. In paragraphs such as ¶0139 of Stewart, it is stated that “In embodiments, for example, the GUI may include a selection tool that can facilitate refining selections of highlighted EGMs, select particular EGMs and/or activations, and/or the like.””. This further shows that Stewart’s inputs into the GUI are used to manipulate data of the received EP maps similar to that of the instant application. Since the claim limitations only require user input is a freehand drawing, any arguments of what is considered “high level” is moot.
Applicant states (see Pages 8-9 of the Remarks):
“More importantly, every user action in Stewart that can affect annotations is tied to selecting or manually editing specific data points/EGMs. See id. at I [0092]. The propagation described in Stewart is conventional propagation of a manual, point-specific correction, which is exactly the type of "pinpointed manual corrections" the Applicant's systems and methods are intended to avoid. See Specification at 1 0013 ("Rather than having the physician enter pinpointed manual corrections, the disclosed technique relies instead on high-level insights made by the physician, typically letting the physician enter certain general clinically meaningful tendencies on the EP map ").”
The examiner is not persuaded as Stewart discloses making user inputs to identify regions of interest. Further Stewart selects regions of interest which are then manipulated based on the selection, rather than a pinpointed approach as argued. Paragraph ¶0092 of Stewart in fact teaches away from a pinpointed approach stating “Due to the abundance of data available in automated mapping (e.g., mapping completed by the computer system with minimal human input related to the incoming data), it is not practical for the operator to review and annotate data manually. However, human input can be a valuable addition to the data, and so when user input is provided it is necessary for the computer system to automatically propagate and apply it to more than one data point at a time.”. This disclosure shows that input is accounted for tp automate regional calculations, not a adjustment to singular data points. Further the claim limitations require “automatically recalculating one or more of the EP values in response to the clinical freehand-drawn input,” which the examiner maintains is shown in ¶0092 of Stewart, as well as in ¶0139 “the GUI may include a selection tool that can facilitate refining selections of highlighted EGMs, select particular EGMs and/or activations, and/or the like.”. Therefore, the rejections are being maintained.
Applicant's arguments filed 11DEC2025 regarding the rejections under 35 USC 101 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Page 10 of the Remarks):
“Applicant's claims do not recite a mental process that can be practically performed in the human mind. No human can practically receive an electrophysiological map comprising thousands of automatically derived LAT or voltage points overlayed on a three-dimensional cardiac surface and then, in response to a freehand-drawn activation path or scar circle, automatically recalculate dozens or hundreds of those LATs or potentials so that they become consistent with the physician's drawn clinical hint.”
The examiner is not persuaded. The act of receiving the data is insignificant extra-solution activity, which amounts to data gathering, which falls under step 2A prong 2 of the 101 analyses. The claim limitation “receiving an electrophysiological (EP) map of at least a portion of a surface of a cardiac chamber, the EP map comprising multiple EP values overlayed at multiple respective positions on the surface” is only requiring that one acquires this already developed map of EP data. Since the information is only received and is necessary to perform the claimed process, a clinician can simply view the received information to further perform the next steps of processing. This is additionally true to receiving the freehand drawn inputs on the map. The amount of data is not relevant as the data, according to the limitations, is already collected and received for one to view. A user is not required to collect this data by hand nor develop a map based on the data, nor input any freehand notes onto the map. A clinician would understand that annotated EP maps may be recalculated to be consistent with a drawn input , by adjusting a level-of-confidence threshold of the EP values in the one or more regions, as adjusting of a threshold only requires that the clinician understands the calculation for confidence levels. The adjustment calculations can be performed by hand, or using tools such as excel to expedite calculations, and these calculations can be performed by the clinician regardless of the amount of data provided as the claims are non-limiting to a timeframe, data set size, or if this threshold is per data point and/or based on one set of annotations encompassing a region. Therefore, the examiner is maintaining the rejection.
“No human can practically, in their mind or with pen and paper, adjust windows of interest, perform piecewise regression on selected points, re-annotate electrograms, or modify outlier-detection thresholds for points inside a drawn region in real time across a high-density map acquired with modern multi-electrode catheters. See id. at " [0016]-[0017], [0040]-[0043].”
The examiner is not persuaded as the actions stated are not required by the claims, nor is the time limitation of “in real time”. Additionally, none of the argued actions, even if they were claimed, require more than a clinician performing calculations and manually inputting corrections to the received EP maps. For example, adjusting windows of interest amounts to merely a clinician selecting various areas of the EP map that are of interest. Calculations of regression values is a formula which a clinician can perform by hand, or using tools such as excel, to calculate and does not require the claimed invention. Annotation of electrograms merely amounts to a clinician drawing on the received EP map, which does not require more than a clinician understanding how to use an annotation function on a computer. Adjustment of thresholds is a mere calculation wich a clinician with understanding of the area may be able to adjust based on detected outliers of data, even when specified to be within a region of interest. The claims recite receiving data as a means for performing the steps of data analysis, which is required in any medical setting to perform most diagnostics or evaluations. The act of receiving data amounts to no more than insignificant extra-solution activity. None of the above is claimed by the instant application, nor as presented amount to more than what a human has been shown to do by hand without the need for an automated process.
“These steps require computational processing of large datasets that is fundamentally impossible for a human to perform mentally or manually within any clinically useful timeframe.”
The examiner is not persuaded as the claims as currently written provide no limitation to data set sizes, or timeframes for which the steps should be completed. The claims recite recalculation of Ep values based on a input drawn on the map, but only further limit this by reciting “wherein the processor is configured to recalculate one or more of the EP values by adjusting a level-of-confidence threshold of the EP values in the one or more regions”. A threshold value is recited singularly here, in regards to a region of EP values. A person may be able to calculate level of confidence using known formulas without much time needed if the threshold here is being recited singularly. Additionally, the claims also recite “automatically recalculate one or more of the EP values”, further showing that the large data sets as argued are not factored into the claim language. Since the claims only require receiving a premade EP map with already input annotations, all that is required of the clinician is performing a few calculations. The large datasets argued by the applicant only appear to apply to the received data as currently claimed.
Applicant states (see Page 11 of the Remarks):
“The claims integrate any such steps into a practical application by automatically correcting inaccuracies in complex, high-density cardiac EP maps that prior-art systems could not reliably produce or correct without tedious point-by-point manual intervention. See id. at 11 [0010]-[0013], [0025]-[0027]. The claimed invention provides a specific technical solution-using physician freehand drawings as new algorithmic constraints to drive window-of- interest adjustment, regression-based path fitting, and outlier-threshold modification-that materially improves the accuracy and clinical usability of electrophysiological maps. See id. at 11 [0014]-[0017], [0037-[0043], [0048]. This constitutes a concrete improvement in the technical field of cardiac electrophysiological mapping and ablation planning, thereby integrating any alleged abstract idea into a practical application.” Because the claimed systems and methods are directed to improvements in the field of EP mapping, they integrate any alleged judicial exception into a practical application under Step 2A, Prong Two of the Alice framework.”
The examiner is not persuaded. The claim elements are recited at a high level of generality and simply amount to data gathering, data display, and data reporting. The additional elements are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional. The invention amounts to no more than automation of calculations that may be performed by hand by one knowledgeable in the field. Additionally, as previously stated the argued elements which show a practical application are not reflected in the claims, and therefore the claims amount to merely automation of threshold calculations, which is not an improvement to the field.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 8, 11-13, 15, 19, & 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claims 1 & 12:
The claims recite “being independent of any of the multiple EP values” in Lines 7 & 7-8 of the claims respectively. The examiner cannot find a disclosure of inputs that are “independent” of any EP values. The Specification does not appear to include any reference to independence, let alone that inputs are independent of the EP values. Therefore, the limitation lacks a written description and is new matter.
Claims 2, 4, 8, & 11 are additionally rejected for depending upon the rejected claim 1.
Claims 13, 15, 19, & 22 are additionally rejected for depending upon the rejected claim 12.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4, 8, 11-13, 15, 19, & 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 1 & 12:
The claims recite “being independent of any of the multiple EP values” in Lines 7 & 7-8 of the claims respectively. It is unclear what the limitation is requiring by the inputs being independent of the EP values, as this could mean the clinician is just entering their own freehand window of interest, or that the freehand drawing does not account for EP values. For the purpose of examination, the examiner is interpreting this as the inputs are made by the clinician regardless of the data the map is showing. Clarification is required.
Claims 2, 4, 8, & 11 are additionally rejected for depending upon the rejected claim 1.
Claims 13, 15, 19, & 22 are additionally rejected for depending upon the rejected claim 12.
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, 2, 4, 8, 11-13, 15, 19, & 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and a mathematical function without significantly more. MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject matter. The stepwise analysis for the instant claim is provided here.
Step 1: Statutory Categories
Claims 1 & 12 are directed to a method (i.e., process) and a apparatus (i.e., machine) respectively, and thus meets the step 1 requirements.
Step 2A: Prong 1; Judicial Exception
Regarding claims 1 & 12 the following claim limitations are an abstract idea:
“automatically recalculating one or more of the EP values in response to freehand drawn input, the EP values being one of: local activation times (LATs), bipolar potentials, and unipolar electrodes” which is a mental process in addition to mathematical when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions; and mathematical concepts are considered laws of nature per MPEP 2106.04(a)(2)(II). In this case, a human could recalculate (i.e., evaluate) the EP values in response to an input using the technology listed, or by a pen and paper with the human mind.
Step 2A: Prong 2; Additional Elements to Integrate J.E. Into A Practical Application
Regarding claims 1 & 12, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea: memory, processor, which are additional elements that amount to generic computer implementation of the abstract idea i “receiving an electrophysiological (EP) map of at least a portion of a surface of a cardiac chamber, the EP map comprising multiple EP values overlayed at multiple respective positions on the surface”, which is insignificant extra-solution activity, which amounts to data gathering; “receiving, via a user interface, a freehand drawn input marked on the EP map by a user, the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation or a circle around at least a portion of a scar region”, which also amount to data gathering; “displaying an updated EP map comprising the recalculated EP values.”, insignificant post-solution activity, which amounts to data display and data reporting.
Step 2B: Significantly More/Inventive Concept
The additional elements of claims 1 & 12, when considered separately and in
combination, do not add significantly more (i.e. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, memory, processor, which are additional elements that amount to generic computer implementation of the abstract idea “receiving an electrophysiological (EP) map of at least a portion of a surface of a cardiac chamber, the EP map comprising multiple EP values overlayed at multiple respective positions on the surface”, which is insignificant extra-solution activity, which amounts to data gathering; “receiving, via a user interface, a freehand drawn input marked on the EP map by a user, the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation or a circle around at least a portion of a scar region”, which also amounts to data gathering; “displaying an updated EP map comprising the recalculated EP values.”, insignificant post-solution activity, which amounts to data display and data reporting, are recited at a high level of generality and simply amount to data gathering, data display, and data reporting. The additional elements are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional.
Dependent claims 2, 4, 8 and 11 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1. The dependent claim limitations are directed to user inputs (Claim 4) and data manipulation (Claims 2, 8, & 11), which are insignificant extra-solution activity and do not amount to more than what is well understood, routine, and conventional.
Dependent claims 13, 15, 19 and 22 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 12. The dependent claim limitations are directed to user inputs (Claim 15) and data manipulation (Claims 13, 19, & 22), which are insignificant extra-solution activity and do not amount to more than what is well understood, routine, and conventional.
In summary, claims 1, 2, 4, 8, 11-13, 15, 19, & 22 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 2, 4, 8, 11-13, 15, 19, & 22 are rejected under pre-AIA 35 U.S.C. 103 as being anticipated by Stewart et al. (US Publication Number 20180296108; Previously Cited) in view of MacAdam et al. (US Publication Number 20120035488; Previously Cited).
Regarding claim 1, Stewart discloses a computer implemented method for electrophysiological mapping, comprising (Stewart Abstract “Systems and methods for facilitating processing of cardiac information based on sensed electrical signals include a processing unit configured to receive a set of electrical signals;…and generate, based on at least one of an annotation waveform corresponding to each electrical signal of the set of electrical signals and a set of annotation mapping values, an annotation histogram.): receiving an electrophysiological (EP) map of at least a portion of a surface of a cardiac chamber (Stewart ¶0007 “wherein the processing unit is further configured to: generate, based on the set of electrical signals and corresponding locations, an electroanatomical cardiac map of a cardiac structure”; ¶0036; ¶0120), the EP map comprising multiple EP values overlayed at multiple respective positions on the surface (Stewart ¶0065 “Consequently, reconstructing and presenting to a user (such as a doctor and/or technician) physiological data pertaining to the heart's electrical activity may be based on information acquired at multiple locations, thereby providing a more accurate and faithful reconstruction of physiological behavior of the endocardium surface. The acquisition of signals at multiple catheter locations in the heart chamber enables the catheter to effectively act as a “mega-catheter” whose effective number of electrodes and electrode span is proportional to the product of the number of locations in which signal acquisition is performed and the number of electrodes the catheter has.”; ¶0126; ¶0096 “According to embodiments, cardiac electric signal features may be extracted from the cardiac electrical signals (e.g., EGMs). Each of the respective points at which a cardiac electrical signal is sensed may have a corresponding set of three-dimensional position coordinates.”); receiving, via a user interface a freehand drawn input marked on the EP map by a user (Stewart ¶0092 “However, human input can be a valuable addition to the data, and so when user input is provided it is necessary for the computer system to automatically propagate and apply it to more than one data point at a time.”; ¶0139 “According to embodiments, a GUI used for presenting the map may include any number of different input tools for manipulating the map. For example, the GUI may include a play/pause button, a tool configured to facilitate manual selection of the histogram bin or bins, tools configured to facilitate manual adjustment of parameters (e.g., signal baseline definitions, thresholds, EGM characteristics, filters, etc.), and/or the like. In embodiments, for example, the GUI may include a selection tool that can facilitate refining selections of highlighted EGMs, select particular EGMs and/or activations, and/or the like.”); and the freehand drawn input comprising a circle around at least a portion of a scar region (Stewart ¶0152 “The user input device used to make the selection may include a mouse, a touchscreen and/or the like, that is used to manipulate a selection tool that is provided on the GUI 632 provided by the display device. The selection tool may include, for example, a brush, a cursor for enclosing the selected region by drawing a freeform shape around the region, an expandable polygon selection tool, a virtual probe 682, and/or the like, and may be, in embodiments, selected from a number of optional selection tools.”); automatically recalculating one or more of the EP values in response to the freehand drawn input. (Stewart ¶0092 “However, human input can be a valuable addition to the data, and so when user input is provided it is necessary for the computer system to automatically propagate and apply it to more than one data point at a time.”; ¶0166 “In embodiments, the GUI may facilitate receiving user input to define, adjust, select, and/or otherwise manipulate one or more selection parameters. For example, embodiments may allow a user to change the radius of the flashlight beam incidence, to expand or contract the size of the selected region.”); the EP values being one of: local activation times (LATs) (Stewart ¶0110 “In embodiments, one or more machine-learning techniques (e.g., supervised and/or unsupervised classifiers, neural networks, deep learning, artificial reasoning, etc.) may be used to modify aspects of embodiments of the method 400 such as, for example, by enhancing (e.g., making more efficient, accurate, etc.) an activation waveform value calculation formula, and/or the like.”; ¶0105; ¶0156), bipolar potentials, and unipolar potentials (Stewart ¶0081 “The signals may be collected directly by the mapping system, and/or obtained from another system using an analog or digital interface. The data stream 302 may include signals such as unipolar and/or bipolar intracardiac electrograms (EGMs), surface electrocardiograms (ECGs),”; ¶0071; ¶0097 “depending on a lead tip configuration of a catheter, the acquired electrical signals may be unipolar signals, bipolar signals, and/or other multipolar signals.”); and displaying an updated EP map comprising the recalculated EP values (Stewart ¶0120 “For example, embodiments may include displaying annotations on the cardiac map that represent features, extracted from the cardiac electrical signals and/or derived from other features, such as, for example, activation times, minimum voltage values, maximum voltages values, maximum negative time-derivatives of voltages, instantaneous potentials, voltage amplitudes, dominant frequencies, peak-to-peak voltages, and/or the like.”; ¶0167 “the processing unit may automatically generate an activation waveform and/or activation histogram corresponding to the selected region, the representation 906 of which may be automatically presented in the second portion 902 of the GUI. In response to further user input, the processing unit may be configured to reposition the virtual probe 908 to a different position on the cardiac map. The processing unit may be configured to cause the display device to represent the portion of the activation waveform and/or activation histogram corresponding to the selection location. In embodiments, the processing unit may be configured to update the display of the representation 906 of the activation waveform and/or histogram continuously, continually, or on demand.”).
Stewart does not disclose the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation. MacAdam in a similar field of EP mapping teaches the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation (MacAdam ¶0030 “The scar is added to the model by a click-and-drag operation in which tissue on the model at the locations of the input device are assigned a color outside of the color scale that indicates local activation or any other parameter of interest, such as grey, black or brown.”; ¶0054 “The interpolation process results in a continuously changing color pattern across the surface of the anatomical model which provides insight to the clinician as to the location of the earliest activation time, locations of necrosed or diseased tissue, indications of an aberrant cycle length, and the like.”), Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the system, as disclosed by Stewart, so as to include the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation, as taught by MacAdam, because it allows the system to monitor and adjust the mapping system to reduce procedure time and mapping data inaccuracies (MacAdam ¶0005-¶0006; ¶0054).
Regarding claim 2, Stewart further discloses adjusting one or more of the positions to be consistent with the freehand-drawn input. (Stewart ¶0150 “To do so, the processing unit may be configured to position the virtual probe 682 at one or more different positions on the cardiac map, in response to receiving a user input. Examples of user input that may be indicative of positioning the virtual probe 682 at a position include, but are not limited to, a single or double mouse click, a touch on a touchscreen, hovering a cursor over the selection location, and/or the like. After the virtual probe 682 is at a position, the processing unit may be configured to reposition the virtual probe 682 to a different position on the cardiac map and/or the surface map, in response to receiving a user input.”; ¶0163; ¶0166; ¶0105).
Regarding claim 4, Stewart further discloses wherein the freehand- drawn input is electronically drawn on the EP map using a touchscreen displaying the EP map. (Stewart ¶0123 “Activation histogram waveforms may be presented on a display device, and may be associated with a cardiac map. Activation histogram waveforms may facilitate identifying and focusing on certain cardiac events, small tissue regions with activation times satisfying a certain set of criteria, and/or the like.” ; ¶0137 “The GUI may be configured to highlight regions of an electroanatomical map in response to user selection of a portion of a representation of an activation histogram. In this manner, embodiments of the histogram waveform may represent the relative contributions of activations from certain regions or time periods on activation propagation. According to embodiments, the activation histograms may be used to facilitate highlighting regions of interest on a map”; ¶0151-¶0152; ¶0149 “In embodiments, individual activation locations may be indicated using representations 680 such as “Xs,” raised bumps, and/or the like.”; ¶0150 “Examples of user input that may be indicative of positioning the virtual probe 682 at a position include, but are not limited to, a single or double mouse click, a touch on a touchscreen”; ¶0148; ¶0152).
Regarding claim 8, Stewart further discloses wherein recalculating one or more of the EP values comprises adjusting a level-of-confidence threshold of the EP values in the one or more regions. (Stewart ¶104 “The specified region may be defined using any number of different measurements of distance (e.g., a rectilinear distance, L1, a Euclidean distance, L2, etc.), time, relevance (e.g., confidence levels, weightings, etc.).”; ¶0166; ¶0078).
Regarding claim 11, Stewart further discloses wherein the user interface is one of a touchscreen, a computer mouse, and a trackball (Stewart ¶0148 “644 and select the portion of the histogram waveform 644 to which the cursor points, for example, by pressing a mouse button, tapping a touchscreen, and/or the like”; ¶0152 “Selecting a region of the map may include, for example, circling the region of the map using a mouse or touchscreen device to manipulate a cursor, brushing over the region of the map using an input device to manipulate a brush, and/or the like.”).
Regarding claim 12, Stewart discloses a system for electrophysiological mapping (Stewart Abstract “Systems and methods for facilitating processing of cardiac information based on sensed electrical signals include a processing unit configured to receive a set of electrical signals;…and generate, based on at least one of an annotation waveform corresponding to each electrical signal of the set of electrical signals and a set of annotation mapping values, an annotation histogram.), comprising: a memory (Stewart ¶0075 “As shown in FIG. 2, the processing unit 200 may be implemented on a computing device that includes a processor 202 and a memory 204.”; ¶0082; ¶0156) configured to store an electrophysiological (EP) map of at least a portion of a surface of a cardiac chamber (Stewart ¶0007 “wherein the processing unit is further configured to: generate, based on the set of electrical signals and corresponding locations, an electroanatomical cardiac map of a cardiac structure”; ¶0036; ¶0120), the EP map comprising multiple EP values overlayed at multiple respective positions on the surface (Stewart ¶0065 “Consequently, reconstructing and presenting to a user (such as a doctor and/or technician) physiological data pertaining to the heart's electrical activity may be based on information acquired at multiple locations, thereby providing a more accurate and faithful reconstruction of physiological behavior of the endocardium surface. The acquisition of signals at multiple catheter locations in the heart chamber enables the catheter to effectively act as a “mega-catheter” whose effective number of electrodes and electrode span is proportional to the product of the number of locations in which signal acquisition is performed and the number of electrodes the catheter has.”; ¶0126; ¶0096 “According to embodiments, cardiac electric signal features may be extracted from the cardiac electrical signals (e.g., EGMs). Each of the respective points at which a cardiac electrical signal is sensed may have a corresponding set of three-dimensional position coordinates.”); and a processor, (Stewart ¶0075 “As shown in FIG. 2, the processing unit 200 may be implemented on a computing device that includes a processor 202 and a memory 204.”; ¶0082; ¶0156) which is configured to: receive, via a user interface a freehand drawn input marked on the EP map by a user (Stewart ¶0092 “However, human input can be a valuable addition to the data, and so when user input is provided it is necessary for the computer system to automatically propagate and apply it to more than one data point at a time.”; ¶0139 “According to embodiments, a GUI used for presenting the map may include any number of different input tools for manipulating the map. For example, the GUI may include a play/pause button, a tool configured to facilitate manual selection of the histogram bin or bins, tools configured to facilitate manual adjustment of parameters (e.g., signal baseline definitions, thresholds, EGM characteristics, filters, etc.), and/or the like. In embodiments, for example, the GUI may include a selection tool that can facilitate refining selections of highlighted EGMs, select particular EGMs and/or activations, and/or the like.”); the freehand drawn input comprising a circle around at least a portion of a scar region (Stewart ¶0152 “The user input device used to make the selection may include a mouse, a touchscreen and/or the like, that is used to manipulate a selection tool that is provided on the GUI 632 provided by the display device. The selection tool may include, for example, a brush, a cursor for enclosing the selected region by drawing a freeform shape around the region, an expandable polygon selection tool, a virtual probe 682, and/or the like, and may be, in embodiments, selected from a number of optional selection tools.”); and automatically recalculate one or more of the EP values in response to the clinical input. (Stewart ¶0092 “However, human input can be a valuable addition to the data, and so when user input is provided it is necessary for the computer system to automatically propagate and apply it to more than one data point at a time.”; ¶0166 “In embodiments, the GUI may facilitate receiving user input to define, adjust, select, and/or otherwise manipulate one or more selection parameters. For example, embodiments may allow a user to change the radius of the flashlight beam incidence, to expand or contract the size of the selected region.”); the EP values being one of. local activation times (LATs) (Stewart ¶0110 “In embodiments, one or more machine-learning techniques (e.g., supervised and/or unsupervised classifiers, neural networks, deep learning, artificial reasoning, etc.) may be used to modify aspects of embodiments of the method 400 such as, for example, by enhancing (e.g., making more efficient, accurate, etc.) an activation waveform value calculation formula, and/or the like.”; ¶0105; ¶0156), bipolar potentials, and unipolar potentials (Stewart ¶0081 “The signals may be collected directly by the mapping system, and/or obtained from another system using an analog or digital interface. The data stream 302 may include signals such as unipolar and/or bipolar intracardiac electrograms (EGMs), surface electrocardiograms (ECGs),”; ¶0071; ¶0097 “depending on a lead tip configuration of a catheter, the acquired electrical signals may be unipolar signals, bipolar signals, and/or other multipolar signals.”); and displaying an updated EP map comprising the recalculated EP values (Stewart ¶0120 “For example, embodiments may include displaying annotations on the cardiac map that represent features, extracted from the cardiac electrical signals and/or derived from other features, such as, for example, activation times, minimum voltage values, maximum voltages values, maximum negative time-derivatives of voltages, instantaneous potentials, voltage amplitudes, dominant frequencies, peak-to-peak voltages, and/or the like.”; ¶0167 “the processing unit may automatically generate an activation waveform and/or activation histogram corresponding to the selected region, the representation 906 of which may be automatically presented in the second portion 902 of the GUI. In response to further user input, the processing unit may be configured to reposition the virtual probe 908 to a different position on the cardiac map. The processing unit may be configured to cause the display device to represent the portion of the activation waveform and/or activation histogram corresponding to the selection location. In embodiments, the processing unit may be configured to update the display of the representation 906 of the activation waveform and/or histogram continuously, continually, or on demand.”).
Stewart does not disclose the clinical input comprising one or more of an activation path indicating a direction of wave propagation. MacAdam in a similar field of EP mapping teaches the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation (MacAdam ¶0030 “The scar is added to the model by a click-and-drag operation in which tissue on the model at the locations of the input device are assigned a color outside of the color scale that indicates local activation or any other parameter of interest, such as grey, black or brown.”; ¶0054 “The interpolation process results in a continuously changing color pattern across the surface of the anatomical model which provides insight to the clinician as to the location of the earliest activation time, locations of necrosed or diseased tissue, indications of an aberrant cycle length, and the like.”); Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the system, as disclosed by Stewart, so as to include the freehand drawn input being independent of any of the multiple EP values and comprising one or more of an activation path indicating a direction of wave propagation, as taught by MacAdam, because it allows the system to monitor and adjust the mapping system to reduce procedure time and mapping data inaccuracies (MacAdam ¶0005-¶0006; ¶0054).
Regarding claim 13, Stewart further discloses wherein the processor is further configured to adjust one or more of the positions to be consistent with the freehand-drawn input. (Stewart ¶0150 “To do so, the processing unit may be configured to position the virtual probe 682 at one or more different positions on the cardiac map, in response to receiving a user input. Examples of user input that may be indicative of positioning the virtual probe 682 at a position include, but are not limited to, a single or double mouse click, a touch on a touchscreen, hovering a cursor over the selection location, and/or the like. After the virtual probe 682 is at a position, the processing unit may be configured to reposition the virtual probe 682 to a different position on the cardiac map and/or the surface map, in response to receiving a user input.”; ¶0163; ¶0166; ¶0105).
Regarding claim 15, Stewart further discloses wherein the freehand-drawn input is electronically drawn on the EP map using a touchscreen displaying the EP map. (Stewart ¶0123 “Activation histogram waveforms may be presented on a display device, and may be associated with a cardiac map. Activation histogram waveforms may facilitate identifying and focusing on certain cardiac events, small tissue regions with activation times satisfying a certain set of criteria, and/or the like.” ; ¶0137 “The GUI may be configured to highlight regions of an electroanatomical map in response to user selection of a portion of a representation of an activation histogram. In this manner, embodiments of the histogram waveform may represent the relative contributions of activations from certain regions or time periods on activation propagation. According to embodiments, the activation histograms may be used to facilitate highlighting regions of interest on a map”; ¶0151-¶0152; ¶0149 “In embodiments, individual activation locations may be indicated using representations 680 such as “Xs,” raised bumps, and/or the like.”; ¶0150 “Examples of user input that may be indicative of positioning the virtual probe 682 at a position include, but are not limited to, a single or double mouse click, a touch on a touchscreen”; ¶0148; ¶0152).
Regarding claim 19, Stewart further discloses wherein the processor is configured to recalculate one or more of the EP values by adjusting a level-of-confidence threshold of the EP values in the one or more regions. (Stewart ¶104 “The specified region may be defined using any number of different measurements of distance (e.g., a rectilinear distance, L1, a Euclidean distance, L2, etc.), time, relevance (e.g., confidence levels, weightings, etc.).”; ¶0166; ¶0078).
Regarding claim 22, Stewart further discloses wherein the user interface is one of a touchscreen, a computer mouse, and a trackball. (Stewart ¶0148 “644 and select the portion of the histogram waveform 644 to which the cursor points, for example, by pressing a mouse button, tapping a touchscreen, and/or the like”; ¶0152 “Selecting a region of the map may include, for example, circling the region of the map using a mouse or touchscreen device to manipulate a cursor, brushing over the region of the map using an input device to manipulate a brush, and/or the like.”).
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 extension fee 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 date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796