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 .
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 01/05/2026.
Response to Amendment
The examiner acknowledges the amendments made to the claims 21, 24, 26, 36, 40, 43 and 44 with claims 27-31 cancelled in prosecution. Currently claims 21-26 and 32-44 are pending in the present application.
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) 21-26, 32-39 is/are rejected under 35 U.S.C. 103 as being anticipated by Soto et al (US Patent No 20210145344) in view of Govari (US Patent No 20110137153). Examiner realizes that the Soto application was published on May 20, 2021 which falls after the claimed priority date of the present application. However, the Soto application claims publication priority to PCT/US2018/041654 which contains a priority date of July 11, 2018 thereby qualifying the Soto reference as eligible prior art.
Regarding claim 21, Soto teaches a medical system (electro atomical system 8, [0025]), comprising: (a) a catheter (catheter 13, [0030]), comprising: (i) a shaft terminating into a distal end (see fig 2 for catheter 13 imposed to a distal end), (ii) at least one arm attached to the distal end of the shaft (distal end of catheter 13 can be defined as at least one arm, fig 2), the at least one arm being configured to be inserted into an anatomical feature of a living subject (it is understood that the catheter 13 may be typically introduced within the heart or vasculature of a patient, [0031]), and (iii) at least one contact electrode attached to the at least one arm (measurement electrode 17, [0030]), the at least one contact electrode being configured to contact tissue located within the anatomical feature of the living subject (electrode 17… can be used for contact mapping and measurements within the heart, [0033]) ; (b) a display (display 23, [0057]); and (c) a processing module configured to receive signals from the at least one contact electrode (processor 28 configured to receive and compute electrophysiology signals collected by electrode 17, [0044]), the processing module being configured to: (i) assess a quality of contact of each contact electrode of the at least one contact electrode with a respective tissue located within the anatomical feature of the living subject (see [0044]-[0045] in which the system 8 via the processor 28 is able to identify signal contact quality from the contact electrode 17 as well as determining signal quality scores) including: (1) express the quality of contact directly in terms of a measured electrical impedance by the respective contact electrode of the at least one contact electrode.; or (2) express the quality of contact indirectly in terms of a contact force, a contact pressure or an IEGM amplitude, by the respective contact electrode of the at least one contact electrode (wherein the quality of contact score is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, [0012], wherein this data can be displayed via a graphical representation), (ii) render to the display a respective visual feature of electrical activity signals for each contact electrode of the at least one contact electrode (see [0057]-[0059] in which a graphical representation of the signal quality score is output to the display 23 from the contact electrode 17), and (iii) modify on the display the respective visual feature of the electrical activity signals in response to the assessed quality of contact of the respective contact electrode making direct contact with the tissue located within the anatomical feature of the living subject ([0057]-[0059] describe how the visual representations of the quality score or contact quality can be displayed by either using a color gradient to display contact quality or by using a numerical output to display contact quality thereby modifying a visual feature on the display 23), including: (1) increase a brightness of the respective visual feature or (2) change a color of the respective visual feature (the graphical representation of the signal quality score can be colored to represent different contact quality, [0008], thereby having different or changing colors for different qualities).
Soto does not explicitly state that the display features in which are being modified are made in direct response to the assessed quality of contact of the respective contact electrode alone.
However, Soto does state that in paragraph [0012] that the quality score which is the feature that is being displayed and visually modified is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, wherein this data can be displayed via a graphical representation of the contact force, and the contact force parameter is a direct indication of the contact quality as per stated in the amended claim limitations. Therefore, contact quality is a factor which is being accounted for in the visually modified displays. Furthermore, the analogous contact mapping probe which is defined by Govari also teaches that while doing an analogous mapping technique of the anatomical feature of the patient that the contact quality of the probe against the anatomical feature is constantly measured and assessed as to know that the contact quality of the probe may be sufficient for the mapping technique, and in which there is a feedback and alarm display system which notifies the user if the contact quality score is not sufficient enough for mapping, [0031]-[0033].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the teachings of both the gradient, brightness and color display system which may be modified based on a change to the quality score which is a function of contact force, taught by Soto, with that of the teachings of Govari, which directly alert the user of sufficient or insufficient probe contact quality, in order to obtain a visually modifiable interface which is capable of displaying the contact quality score to the user in the form of a gradient, brightness or color display, as taught by Soto, [0012].
Regarding claim 22, Soto teaches the medical system of claim 21, the catheter further comprising a position sensor (wherein the electrode 17 on the catheter 13 can be a roving electrode used for measuring position via the system 8 measurements, [0038], therefore comprising a position sensor).
Regarding claim 23, Soto teaches the medical system of claim 22, the position sensor comprising a first shaft electrode associated with the shaft (electrode 17 can be a roving electrode for measuring position, [0038]).
Regarding claim 24, Soto teaches the medical system of claim 23, the first shaft electrode being configured to estimate a location of the first shaft electrode within the anatomical feature of the living subject (electrode 17 can be a roving electrode for measuring position within the heart or vasculature, [0038]).
Regarding claim 25, Soto teaches the medical system of claim 24, the catheter further comprising a second shaft electrode associated with the shaft (the catheter 13 also may have a plurality of additional electrodes 52, [0032]).
Regarding claim 26, Soto teaches the medical system of claim 25, the first shaft electrode being located proximally relative to the second shaft electrode (the catheter 13 also may have a plurality of additional electrodes 52, [0032] which are found proximal to the first electrode 17, seen in fig 2).
Regarding claim 32, Soto teaches the medical system of claim 21, the processing module further configured to modify the respective visual feature of the electrical activity signals in response to the respective contact electrode losing direct contact with the tissue located within the anatomical feature of the living subject (see [0057]-[0058] which explains the graphical representation of the contact signals measure by processor 28 are displayed when quality scores are between 80 to 100, and if they fall below the threshold, meaning contact is lost then the processor displays the graphical information).
Regarding claim 33, Soto teaches the medical system of claim 32, the processing module further configured to apply a fading effect to the respective visual feature of the electrical activity signals in response to the respective contact electrode losing direct contact with the tissue located within the anatomical feature of the living subject (see [0057]-[0058] which explains the graphical representation of the contact signals measure by processor 28 are displayed when quality scores are between 80 to 100, and if they fall below the threshold, meaning contact is lost then the processor displays the graphical information. Furthermore, [0057] explains the color or brightness gradient used to display data, therefore when the contact is a weaker signal the gradient dims or fades).
Regarding claim 34, Soto teaches the medical system of claim 21, the at least one arm further comprising at least one resilient arm (wherein the catheter 13 is configured to be deployed into the cardiac tissue and have moving force capabilities, [0030]- [0031] thereby constituting it as resilient as it is capable of penetrating anatomic bodies).
Regarding claim 35, Soto teaches the medical system of claim 21, further comprising a console (computer system 20, fig 1), the processing module being located within the console (processor internal to the computer system, see fig 1).
Regarding claim 36, Soto teaches a medical system, comprising: (a) a catheter (catheter 13, [0030]), comprising: (i) a shaft terminating into a distal end (see fig 2 for catheter 13 imposed to a distal end), (ii) at least one arm attached to the distal end of the shaft (distal end of catheter 13 can be defined as at least one arm, fig 2), the at least one arm being configured to be inserted into an anatomical feature of a living subject (it is understood that the catheter 13 may be typically introduced within the heart or vasculature of a patient, [0031]), and (iii) at least one contact electrode attached to the at least one arm (measurement electrode 17, [0030]), the at least one contact electrode being configured to contact tissue located within the anatomical feature of the living subject (electrode 17… can be used for contact mapping and measurements within the heart, [0033]); (b) a display (display 23, [0057]); and (c) a processing module configured to receive signals from the at least one contact electrode (processor 28 configured to receive and compute electrophysiology signals collected by electrode 17, [0044]), the processing module being configured to: (i) assess a quality of contact of each contact electrode of the at least one contact electrode with a respective tissue located within the anatomical feature of the living subject to determine if the quality of contact is above or below a minimal quality contact (see [0044]-[0045] in which the system 8 via the processor 28 is able to identify signal contact quality from the contact electrode 17 as well as determining signal quality scores), (1) assess the quality of contact directly in terms of a measured electrical impedance; or (2) assess the quality of contact indirectly in terms of a contact force, a contact pressure or an IEGM amplitude (wherein the quality of contact score is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, [0012], wherein this data can be displayed via a graphical representation) (ii) render to the display a respective visual feature of electrical activity signals for each contact electrode of the at least one contact electrode (see [0057]-[0059] in which a graphical representation of the signal quality score is output to the display 23 from the contact electrode 17), and (iii) modify, via a fading effect, the respective visual feature of the electrical activity signals in response to the respective assessed quality of contact transitioning below the minimal quality of contact, modify on the display the respective visual feature of the electrical activity signals of the living subject ([0057]-[0059] describe how the visual representations of the quality score or contact quality can be displayed by using a color gradient to display contact quality thereby modifying a visual feature on the display 23, therefore when the contact is a weaker signal the gradient dims or fades).
Soto does not explicitly state that the display features in which are being modified are made in direct response to the assessed quality of contact of the respective contact electrode alone.
However, Soto does state that in paragraph [0012] that the quality score which is the feature that is being displayed and visually modified is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, wherein this data can be displayed via a graphical representation of the contact force, and the contact force parameter is a direct indication of the contact quality as per stated in the amended claim limitations. Therefore, contact quality is a factor which is being accounted for in the visually modified displays. Furthermore, the analogous contact mapping probe which is defined by Govari also teaches that while doing an analogous mapping technique of the anatomical feature of the patient that the contact quality of the probe against the anatomical feature is constantly measured and assessed as to know that the contact quality of the probe may be sufficient for the mapping technique, and in which there is a feedback and alarm display system which notifies the user if the contact quality score is not sufficient enough for mapping, [0031]-[0033].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the teachings of both the gradient, brightness and color display system which may be modified based on a change to the quality score which is a function of contact force, taught by Soto, with that of the teachings of Govari, which directly alert the user of sufficient or insufficient probe contact quality, in order to obtain a visually modifiable interface which is capable of displaying the contact quality score to the user in the form of a gradient, brightness or color display, as taught by Soto, [0012].
Regarding claim 37, Soto teaches the medical system of claim 36, the quality of contact being indicative of the respective contact electrode being in direct contact with the respective tissue ([0049], wherein the contact stability information may also include the contact force of the catheter 13 and the cardiac surface via the electrode 17).
Regarding claim 38, Soto teaches the medical system of claim 36, the at least one arm comprising a plurality of resilient arms (wherein the catheter 13 is configured to be deployed into the cardiac tissue and have moving force capabilities, [0030]- [0031] thereby constituting it as resilient as it is capable of penetrating anatomic bodies, furthermore there may be up to 12 catheters present resulting in a plurality of resilient arms, [0030]).
Regarding claim 39, Soto teaches the medical system of claim 38, the at least one contact electrode comprising a plurality of electrodes associated with each resilient arm of the plurality of resilient arms ([0030], wherein the system may comprise up to twelve catheters and up to 64 electrodes on each catheter).
Claim(s) 40-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soto et al (US Patent No 20210145344) in view of Govari (US Patent No 20110137153) further in view of Schwartz (US Patent No 20180153437) .
Regarding claim 40, Soto teaches the medical method, comprising:(a) receiving respective signals from a plurality of contact electrodes configured to contact tissue at respective locations within an anatomical structure of a patient (electrode 17… can be used for contact mapping and measurements within the heart, [0033], and processor 28 configured to receive and compute electrophysiology signals collected by electrode 17, [0044]); (b) in response to the signals, assessing a respective quality of contact of each of the contact electrodes to determine if the respective quality of contact is above or below a predetermined minimum quality of contact (see [0044]-[0045] in which the system 8 via the processor 28 is able to identify signal contact quality from the contact electrode 17 as well as determining signal quality scores); (1) expressing the quality of contact directly in terms of a measured electrical impedance by the respective contact electrode of the at least one contact electrode.; or (2) expressing the quality of contact indirectly in terms of a contact force, a contact pressure or an IEGM amplitude, by the respective contact electrode of the at least one contact electrode, (wherein the quality of contact score is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, [0012], wherein this data can be displayed via a graphical representation) (c) rendering to a display respective electrical activity received by each contact electrode of the plurality of contact electrodes (see [0057]-[0059] in which a graphical representation of the signal quality score is output to the display 23 from the contact electrode 17); (d) performing a first modification within a first time period to the displayed electrical activity associated with the contact electrodes having a respective quality of contact above the predetermined minimum quality of contact ([0057]-[0059] describe how the visual representations of the quality score or contact quality can be displayed by using a color gradient to display contact quality thereby modifying a visual feature on the display 23, therefore when the contact is a stronger signal the gradient brightens); and (e) performing a fading effect modification to the displayed respective electrical activity associated with the contact electrodes having a respective quality of contact transitioning from above to below the predetermined minimum quality of contact ([0057]-[0059] describe how the visual representations of the quality score or contact quality can be displayed by using a color gradient to display contact quality thereby modifying a visual feature on the display 23, therefore when the contact is a weaker signal the gradient dims or fades).
Soto does not explicitly state that the display features in which are being modified are made in direct response to the assessed quality of contact of the respective contact electrode alone.
However, Soto does state that in paragraph [0012] that the quality score which is the feature that is being displayed and visually modified is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, wherein this data can be displayed via a graphical representation of the contact force, and the contact force parameter is a direct indication of the contact quality as per stated in the amended claim limitations. Therefore, contact quality is a factor which is being accounted for in the visually modified displays. Furthermore, the analogous contact mapping probe which is defined by Govari also teaches that while doing an analogous mapping technique of the anatomical feature of the patient that the contact quality of the probe against the anatomical feature is constantly measured and assessed as to know that the contact quality of the probe may be sufficient for the mapping technique, and in which there is a feedback and alarm display system which notifies the user if the contact quality score is not sufficient enough for mapping, [0031]-[0033].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the teachings of both the gradient, brightness and color display system which may be modified based on a change to the quality score which is a function of contact force, taught by Soto, with that of the teachings of Govari, which directly alert the user of sufficient or insufficient probe contact quality, in order to obtain a visually modifiable interface which is capable of displaying the contact quality score to the user in the form of a gradient, brightness or color display, as taught by Soto, [0012].
Soto nor Govari explicitly teach wherein the fading effect modification occurs within a second time subsequent to the first time period.
However, the analogous system for tracking position and contact quality of an intrabody catheter as disclosed by Schwartz does teach that real time measurements are made regarding the contact quality and that the program code responsible for sending graphical data to the display is updated every one to five seconds, [0204], thereby teaching at least two subsequent time periods in which the graphical data that controls the fading effect is updated.
Therefore, it would have been obvious for one skilled in the art prior than the effective filing date to combine the method of receiving contact quality signals defined by Soto and Govari, to have the multiple subsequent time periods capable of controlling the fading effect taught by Schwartz in order to get accurate real time graphical display data regarding the contact quality of the internal electrodes as taught by Schwartz, [0204].
Regarding claim 41, the combination teaches the medical method of claim 40, the second time window being predefined (Schwartz, real time measurements are made regarding the contact quality and that the program code responsible for sending graphical data to the display is updated every one to five seconds, [0204], thereby indicating a predefined time).
Regarding claim 42, the combination teaches the medical method of claim 40, the second time window ranging between 1 to 3 seconds (Schwartz, real time measurements are made regarding the contact quality and that the program code responsible for sending graphical data to the display is updated every one to five seconds, [0204]).
Regarding claim 43, Soto teaches the medical method of claim 40, the first modification including a brightness increase from an original brightness of the displayed electrical activity associated with the contact electrodes and the fading effect modification being a return to the original brightness from the brightness increase ([0057]-[0059] describe how the visual representations of the quality score or contact quality can be displayed by using a color gradient to display contact quality thereby modifying a visual feature on the display 23, therefore when the contact is a stronger signal the gradient brightens and inadvertently as based on the quality color gradient as contact quality lessens the contact is a weaker signal the gradient dims or fades).
Regarding claim 44, Soto teaches the medical method of claim 40, the first modification including a color change from an original color of the displayed electrical activity associated with the contact electrodes and the fading effect modification being a return to the original color from the color change ([0057]-[0059] describe how the visual representations of the quality score or contact quality can be displayed by using a color gradient to display contact quality thereby modifying a visual feature on the display 23, therefore when the contact is a stronger signal the gradient brightens and changes color, inadvertently as based on the quality color gradient as contact quality lessens the contact is a weaker signal the gradient fades to the original color).
Response to Arguments
Applicant’s arguments with respect to independent claim(s) 21, 36 and 40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, as newly amended, the examiner agrees with the applicant that the limitation of the independent claims 21, 36 and 40 which defines that the visual display is modified based on the direct contact quality of the treatment alone is not explicitly taught by the previous prior art of Soto. However, after further search and consideration, necessitated by the amended claim limitations, it has been found that Soto does state in paragraph [0012] that the quality score which is the feature that is being displayed and visually modified is a function of a surface proximity parameter and a contact force parameter of the catheter electrode, wherein this data can be displayed via a graphical representation of the contact force, and the contact force parameter is a direct indication of the contact quality as per stated in the amended claim limitations. Therefore, contact quality is a factor which is being accounted for in the visually modified displays. Furthermore, after further search and consideration, it has been found that the analogous contact mapping probe which is defined by the new prior art of Govari also teaches that while doing an analogous mapping technique of the anatomical feature of the patient that the contact quality of the probe against the anatomical feature is constantly measured and assessed as to know that the contact quality of the probe may be sufficient for the mapping technique, and in which there is a feedback and alarm display system which notifies the user if the contact quality score is not sufficient enough for mapping, [0031]-[0033]. Therefore, in combination the teachings of both the gradient, brightness and color display system which may be modified based on a change to the quality score as a function of contact force, taught by Soto, with that of the teachings of Govari, which directly alert the user of sufficient or insufficient probe contact quality, would be obvious for one skilled in the art to obtain a visually modifiable interface which is capable of displaying the contact quality score to the user in the form of a gradient, brightness or color display. Therefore, as the new prior art combination teaches the claim limitation as amended, the independent claims 21, 36 and 40 remain rejected under the new prior art of record rejection of Soto in view of Govari which is set forth in the present office action.
As no further remarks have been made regarding the deponent claims, they too remain rejected under the prior art of record rejection set forth in the present office action.
Conclusion
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/LINDA C DVORAK/ Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794