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 .
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.
Claim(s) 1, 5, 7, 9-12, 16, 18, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (EP 3 750 478 – disclosed by Applicant).
In regard to claims 1 and 12, Cohen et al teaches a system and method comprising an input device and processor configured to receive or generate an electrophysiological map (para 1). Cohen et al. acquires intracardiac EGM signals and produces an electrophysiological map for display (para 21 and 22). Cohen et al. teach that bipolar intracardiac EGM amplitudes as sails or bars overlaid on a map, wherein the height of the sails or bars provides a measure of the bipolar intracardiac EGM amplitudes (para 12). Thus, Cohen et al. teaches visualization a first EP parameter on an EP map using a graphical representation that varies in size according to the value of the first EP parameter.
Cohen et al. further teaches processing additional electrophysiological information, including distinguishing primary and secondary activations, and graphically indicating such electrophysiological information on the EP map using different visual characteristics, including different colors and/or shapes (para 16, 17, 33 and 37). Cohen et al. therefore teaches receiving additional EP information and varying a visual indication according to that information.
Cohen et al. does not expressly teach applying the visual indication corresponding to the second EP parameter on the same graphical representation whose size varies according to the first EP parameter.
However, it would have been obvious to one of ordinary skill in the art to apply the visual indication corresponding to the second EP parameter, such as the color differentiation taught by Cohen et al. to the graphical representation whose size/height varies according to the first EP parameter, such that a single graphical representation varies in size according to the first parameter and varies in another visual characteristic according to the second EP parameter. Such modification would advantageously permit multiple EP parameters to be simultaneously and readily distinguished from a single graphical representation, thereby improve the efficient presentation and interpretation of electrophysiological information.
In regard to claims 5 and 16, Cohen et al. further teach that the first RP parameter comprises bipolar electrogram amplitudes. In particular, Cohen et al. teach displaying bipolar EGM amplitudes in the form of sails or bars superimposed on the anatomical map, wherein the height of the sail or bar provides a measure of the bipolar EGM signal amplitudes at the visualized position (para 13).
In regard to claims 7 and 18, Cohen et al. expressly teach that the processor is configured to configure the visual indication of the first EP parameter as bars having heights according to the first EP parameter value (para 13).
In regard to claims 9, 10, 20, and 21, Cohen et al. expressly teach that the processor is configured to visualize the first EP parameter on an EP map of another EP parameter (para 28, visualization module presented bipolar intracardiac EGM activations overlaid of a local activation time (LAT) map).
In regard to claim 11, Cohen et al. expressly teach that the system 20 includes a pointing device such as a mouse or trackball to interact with the processor (para 24). The touch screen is considered to comprise a known suitable alternative input device that one of ordinary skill in the art would find obvious to substitute for the mouse in order to provide the predictable benefit of permitting direct user interaction with the displayed graphical results.
Claim(s) 2, 3, 8, 13, 14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (EP 3 750 478 – disclosed by Applicant) in view of Bauerle et al. (US Publication no. 2006/0036639).
In regard to claims 2 and 13, Cohen et al. is considered to substantially suggest the invention as claimed, however does not teach the processor is further configured to receive from the user, via the input device, a binning of a range of the second EP parameter and apply the visual indication of the second EP parameter according to the received binning. Bauerle et al. discloses a data visualization system having a binned data representation in which bin elements correspond to respective values or range of values (para 8, 10, and 11), and a binning control (i.e., a slider 16) responsive to user input for adjusting the correspondence between the bins and the underlying values (para 9 and 23). Bauerle et al. further teaches that changes to the binning control (slider 16) result in corresponding changes to the displayed visualization (para 9 and 23). It would have been obvious to one of ordinary skill in the art to incorporate the user-adjustable binning functionality of Bauerle et al. into the visualization system of Cohen et al. to allow the user to conveniently adjust the level of detail of the visualization and more readily identify meaningful distinctions or patterns in the displayed EP data.
In regard to claims 3 and 14, Bauerle et al. further teaches that the processor is configured to provide, using a display device and the input device, a graphical user interface (GUI) feature (e.g. slide 16) that lets the user to at least one of: i) select the second EP parameter and ii) configure its binning (para 9 and 23, slide enables configuration of binning). It would have been obvious to include a feature on a GUI to allow a user to configure binning or parameters since it is explicitly taught by Bauerle et al. to facilitate convenient user selection and adjustment of the parameter binning.
In regard to claims 8 and 19, Cohen et al. substantially describes the invention as claimed, and further teaches varying the color of the graphical representations according to EP information (para 17, 28, 33, and 37). Cohen et al. do not expressly teach coloring the graphical representations according to received binning of the second EP parameter. Bauerle et al. teaches that the data visualization system that groups numerical values into bins, wherein the correspondence between the values and bins is adjustable by the user and the displayed visualization is dynamically updated in accordance with the selected binning. It would have been obvious to one of ordinary skill in the art to modify Cohen et al. to assign the disclosed colors to the graphical representations according to the respective bins of the second EP parameter as taught by Bauerly et al. to provide visually distinguishable ranges of the second EP parameter and thereby facilitate rapid identification and comparison of different ranges of EP parameter values on the EP map.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (EP 3 750 478 – disclosed by Applicant) in view of Bauerle et al. (US Publication no. 2006/0036639), further in view of Deno (US 2015/0099992).
In regard to claims 4 and 15, Bauerle et al. the GUI feature lets a user configure the received binning using a slider ruler with one or more user-movable separators of the range of the second EP parameter (slider 16, para 9 and 23). The continuously adjustable slider, which the user moves to dynamically modify the binning of displayed numeral data. Although Bauerle et al. noes not expressly describe the slider as a ruler with one or more user-movable separators of the range of the second EP parameter. Deno et al. describes a system and method for generating electrophysiology maps. Figure 3 of Deno shows a display for displaying an EP map 300 wherein the display includes a slider 304 for allowing user selection of lateness threshold and lateness bound. The slider 304 is considered depicted with one or more moveable separators 305 and 306 to create a range of bin boundaries (see para 44, 47, 48). It would have been obvious to one of ordinary skill in the art to modify the slider of Bauerle et al. to include one or more moveable separators along a parameter range to provide convenient and intuitive user control over the boundaries of the respective bins, thereby allowing displayed EP data to be readily customized to ranges of interest.
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. (EP 3 750 478 – disclosed by Applicant) in view of Relan et al. (US Publication no. 2019/0038165).
In regard to claims 6 and 7, Cohen et al. substantially describe the invention as claimed, however do not teach that the second EP parameter is one of fractionation count, activity duration, and wavefront candidates. Relan et al. teach a system and method for electrophysiological mapping in which an electrogram is analyzed to determine EP metrics including activity duration, such as the QRS duration, near field component duration, and far field component duration, and further teaches graphically representing such metrics on a cardiac model (para 14 and 28). It would have been obvious to one of ordinary skill in the art to display an activity duration metric of a cardiac event since this is demonstrated by Relan et al. to present visualization of temporal characteristics of cardiac electrical activity in order to distinguish abnormal from normal conduction.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 21 September 2026
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