DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The action is in response to amendments filed on 03/31/2026. Claims 17-18 have been cancelled. Claims 1-18 are pending and examined below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 9-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190183378 A1 (hereinafter referred to as “Mosesov”).
Regarding claims 1, 10, 12, and 16, Mosesov, a catheter electrode system, teaches A computer-implemented method of providing real-time visual feedback of intraluminal catheter engagement/A graphical user interface (GUI) for providing real-time visual feedback of intraluminal catheter engagement/A computer system comprising at least one processing circuitry, configured to execute a method of providing real-time visual feedback of intraluminal catheter engagement/A non-transitory computer readable storage medium tangibly embodying a program of instructions that, when executed by a computer, cause the computer to perform a method of providing real-time visual feedback of intraluminal catheter engagement using a catheter that comprises one or more electrodes placed on a catheter distal end assembly (“The distal end portion 26 of the shaft 28 of the exemplary catheter 24 may have a lariat shape. See also FIG. 2. In this embodiment, the lariat shape may be formed by, for example, a shape memory wire disposed within the shaft. A tip electrode 22 and a number of ring electrodes 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H, 20I (which, may be referred to herein individually and generically as a ring electrode 20 or in the multiple as the ring electrodes 20) may be disposed on the distal end portion 26 of the shaft 28”; paragraph [0045]; Figure 2), the method comprising:
while a catheter is in a luminal organ (“to enable a physician to guide the distal end portion to perform a diagnostic or therapeutic procedure such as, for example only, an ablation or mapping procedure on the heart of the patient”; paragraph [0044]; “The system 70 may be configured for a number of functions for guiding the elongate medical device 16 to a target site within the body of a patient 98, such as the heart 92, and for assessing contact between the elongate medical device 84 and the tissue of the patient 98”; paragraph [0069]; shown in Figure 21) of a patient:
rendering on a display a graphical representation of the catheter distal end assembly and the one or more electrodes thereon (“For instance, these outputs may be output to the graphical user interface 68 (see FIG. 7). Along these lines, the assessed value for each electrode may be displayed on the graphical user interface 68 along with a graphical depiction of the catheter to provide a user with feedback on the contact status of each electrode. That is, the impedance values may be utilized for, among other things, to assess electrode contact with tissue”; paragraph [0082]);
for each electrode of the one or more electrodes:
identifying a range of impedance between a first threshold value corresponding to baseline tissue contact and a second threshold value corresponding to contact saturation for each of the one or more electrodes (paragraph [0117]-[0118]);
defining a graphical feature index that associates impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes (“When output to a display, such indication could, for example, be used to color geometry surfaces, scale voltage maps, and/or assist with lesion prediction”; paragraph [0118]);
repeatedly measuring impedance at each of the one or more electrodes (“the process may continue for the duration of the procedure”; paragraph [0113]); and
dynamically updating a respective visual feature of the graphical representation of each of the one or more electrodes based on the impedance measured and the graphical feature index, thereby providing dynamic visual feedback indicative of quality of intraluminal catheter engagement with a tissue wall (paragraph [0113], [0117]-[0118]).
Regarding claim 2, Mosesov teaches wherein the luminal organ is a heart of the patient (paragraph [0069]; shown in Figure 21).
Regarding claim 3, Mosesov teaches wherein the distal end assembly is a basket comprising multiple splines, the electrodes being distributed on the splines (paragraph [0094]; Figure 16A).
Regarding claim 4, Mosesov teaches further comprising determining for each electrode a respective impedance-proximity response curve (paragraph [0113]; Figure 20), comprising:
obtaining by the electrode a plurality of impedance values (paragraph [0113]; Figure 20);
identifying a maximal impedance value and a minimal impedance value (paragraph [0113]; Figure 20);
scaling an impedance-proximity response profile according to the maximal impedance value and the minimal impedance value to obtain a respective impedance-proximity response curve (paragraph [0113]; Figure 20);
determining the first threshold value and the second threshold value according to the respective impedance-proximity response curve (paragraph [0113]; Figure 20); and
defining the respective graphical features index according to first threshold value and the second threshold value (paragraph [0113]; Figure 20).
Regarding claim 5, Mosesov teaches wherein the respective graphical features index includes a first visual feature that represents impedance values below a first threshold value corresponding to baseline tissue contact, a second visual feature that represents impedance values above a second threshold value corresponding to contact saturation, and a plurality of other visual features that represent, respectively, a plurality of respective impedance values between the first threshold value and the second threshold value (paragraph [0118]).
Regarding claim 6, Mosesov teaches wherein the visual feature is color (paragraph [0118]).
Regarding claim 9, Mosesov teaches comprising rendering on the display a graphical representation of the luminal organ (paragraph [0113], [0117]-[0118]; Figures 23A-B).
Regarding claim 11, Mosesov teaches wherein the visual feature is any one of:
color; shading in grey level; shape; and rate of flashing (paragraph [0118]).
Regarding claim 13, Mosesov teaches is operatively connectable to a catheter-based electrophysiology mapping system comprising the catheter (paragraph [0113], [0117]-[0118]) and wherein the luminal organ is a heart of the patient (paragraph [0069]; shown in Figure 21).
Regarding claim 14, Mosesov teaches further comprising the catheter, wherein the distal end assembly is a basket comprising multiple splines, the electrodes being distributed on the splines (paragraph [0094]; Figure 16A).
Regarding claim 15, Mosesov teaches wherein the visual feature is any one of: color; shading in grey level; shape; and rate of flashing (paragraph [0118]).
Regarding claim 17, Mosesov teaches further comprising; tracking location of the catheter distal end in a coordinate system (paragraphs [0044], [0069], [0113], [0117]-[0118]); rendering a model of luminal organ on the display, wherein the model is defined in the coordinate system, and wherein the graphical representation of the catheter distal end is rendered with respect to the model at its tracked location (paragraphs [0044], [0069], [0113], [0117]-[0118]).
Regarding claim 18, Mosesov teaches wherein the at least one processing circuitry if further configured to: track location of the catheter distal end in a coordinate system (paragraphs [0044], [0069], [0113], [0117]-[0118]); rendering a model of luminal organ on the display, wherein the model is defined in the coordinate system and wherein the graphical representation of the catheter distal end is rendered with respect to the model at its tracked location (paragraphs [0044], [0069], [0113], [0117]-[0118]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosesov, as applied to claim 1 above, and further in view of US 20150011852 A1 (hereinafter referred to as “Kesteren”).
Regarding claim 7, Mosesov does not explicitly teach wherein the visual feature is shading in a gray scale.
However, Kesteren teaches wherein the visual feature is shading in a gray scale (paragraph [0210]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Mosesov, to have a gray scale visual feature, as taught by Kesteren, because doing so would be the simple substitution of one known element (the mapping of Mosesov) with another (the mapping of Kesteren) in order to achieve a predictable result namely a means of mapping an organ.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mosesov, as applied to claim 1 above, and further in view of US 20160022375 A1 (hereinafter referred to as “Blake”).
Regarding claim 8, Mosesov does not explicitly teach wherein the visual feature is a rate of flashing.
However, Blake teaches wherein the visual feature is a rate of flashing (paragraph [0039]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Mosesov, to have a gray scale visual feature, as taught by Kesteren, because doing so would be the simple substitution of one known element (the mapping of Mosesov) with another (the mapping of Kesteren) in order to achieve a predictable result namely a means of mapping an organ.
Response to Arguments
Applicant's arguments filed 03/31/2026 with regards to the prior art rejections have been fully considered but they are not persuasive.
Regarding claim 1, 10, 12, and 16, Applicant traverses the prior art rejection of record.
Specifically, Applicant argues that the prior art does not teach or suggest “dynamically updating a respective visual feature of the graphical representation of each of the one or more electrodes”. Examiner respectfully disagrees.
Mosesov teaches the limitations in paragraph [0113], [0117]-[0118]. Specifically paragraph [0118] recites “For instance, ranges of contact indications (e.g., insufficient, sufficient, elevated, etc.) may be generated as set forth above. When output to a display, such indication could, for example, be used to color geometry surfaces, scale voltage maps, and/or assist with lesion prediction”. Under the broadest reasonable interpretation this reads upon being a “graphical representation of each of the one or more electrodes”.
As such Applicant’s arguments are found to be unpersuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 ABID A MUSTANSIR whose telephone number is (408)918-7647. The examiner can normally be reached M-F 10 am to 6 pm Pacific Time.
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791
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