DETAILED ACTION
This action is in response to applicant’s election of Group I in the response received on 3/16/2026. Claims 1-20 were previously pending. Claims 4, 14 and 18-20 have been withdrawn from further consideration. A complete action on the merits of claims 1-3, 5-13 and 15-17 follows below.
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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 3/16/2026 is acknowledged.
Furthermore, during a phone interview on 3/30/2026 applicant elected without traverse Species I, see the attached Interview Summary. Thereby, claims 4 and 14 have been withdrawn from further consideration.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SHEN et al. (US Pub. No. 2023/0097773).
Regarding Claim 1, SHEN teaches a cryogenic balloon catheter system for use in an ablation procedure (abstract and Figs. 1-2), the cryogenic balloon catheter system comprising:
a balloon catheter including a shaft (a shaft is shown in Fig. 2 proximal to the balloon), and an expandable balloon attached to a distal portion of the shaft (Fig. 2);
a plurality of sensors 4, 5 each configured to sense an ablation parameter (temperature) during an ablation phase of the ablation procedure and to generate a sensor output based on the sensed ablation parameter ([0012] and [0021]-[0026] and Fig. 2);
a controller (control device 2-Fig. 1) configured to receive the sensor output from each of the plurality of sensors and calculate a plurality of ablation metrics each based on one or more of the sensed ablation parameters, and to generate a plurality of ablation quality indicator outputs each based on a comparison of one of the calculated ablation metrics and a respective target ablation metric ([0028], [0037], [0054]-[0063] and [0066]-[0067]); and
a graphical display 3 operatively coupled to the controller and configured to display a plurality of graphical ablation quality indicators having a visual appearance based on a respective one of the ablation quality indicator outputs ([0012]-[0015], [0024]-[0026], [0037], [0054]-[0061] and [0073] and Figs. 3-8).
Regarding Claim 2, SHEN teaches wherein the plurality of sensors 4, 5 includes a temperature sensor configured to generate a temperature sensor output indicative of a sensed expandable balloon temperature, and the plurality of ablation metrics includes an expandable balloon temperature at a prescribed time of the ablation phase, and wherein the target ablation metric is a target sensed expandable balloon temperature at the prescribed time ([0012]-[0015], [0021]-[0029], [0071]-[0073], [0079]-[0080] and Figs. 1-8).
Regarding Claim 3, SHEN teaches wherein the plurality of ablation metrics includes a lowest expandable balloon temperature during the ablation phase, and wherein the target ablation metric is a target lowest sensed expandable balloon temperature during the ablation phase ([0007]-[0011], [0018]-[0020], [0064]-[0067] and [0080]).
Regarding Claim 5, SHEN teaches wherein the visual appearance of each of the ablation quality indicators varies (temperature measurements displayed on the screen) based on the respective comparison of the calculated ablation metric and the target ablation metric (the flow rate adjustment and the target tissue temperature, see [0028], [0037], [0054]-[0063] and [0066]-[0067]).
Regarding Claim 6, SHEN teaches wherein the visual appearance of each of the ablation quality indicators provides a visual indication to the user of whether the calculated ablation metric meets the target ablation metric ([0012]-[0015], [0022]-[0028], [0037] and [0058]-[0069]).
Regarding Claim 7, SHEN teaches wherein each of the target ablation metrics is pre-programmed in the controller ([0057]-[0069]).
Regarding Claim 8, SHEN teaches wherein one or more of the target ablation metrics is selected by a user via a user interface operatively coupled to the graphical display (“On the other hand, the input field provided on the display device can receive the preset balloon temperature from the operator, and the system then compares the preset balloon temperature value with the comparative temperature value” [0037] and [0062]).
Regarding Claim 9, SHEN teaches wherein the graphical display is configured to display, based on an output from the controller, a target ablation metric graph based on one or more of the target ablation metrics over time for the duration of the ablation phase ([0012]-[0017], [0021]-[0024], [0037], [0061]-[0062] and [0080]).
Regarding Claim 10, SHEN teaches wherein the target ablation metric graph is based on the one or more target ablation metrics and a pre-determined tolerance (lower and upper limits or threshold range [0018]-[0019], [0070]-[0072]).
Regarding Claim 11, SHEN teaches a control system for cryogenic balloon catheter system for use in an ablation procedure, the control system comprising:
a controller 2 (Fig. 1) configured to: receive a plurality of sensor outputs (from sensors 4 and 5) each based on a sensed ablation parameter ([0012] and [0021]-[0026] and Fig. 2);
calculate a plurality of ablation metrics each based on one or more of the sensed ablation parameters ([0028], [0037], [0054]-[0063] and [0066]-[0067]), and;
generate a plurality of ablation quality indicator outputs each based on a comparison of one of the calculated ablation metrics and a respective target ablation metric ([0012]-[0017], [0021]-[0024], [0037], [0061]-[0062] and [0080]); and
a graphical display 3 operatively coupled to the controller 2 (Fig. 1) and configured to display a plurality of graphical ablation quality indicators having a visual appearance based on a respective one of the ablation quality indicator outputs ([0037], [0061]-[0062] and Figs. 3-8).
Regarding Claim 12, SHEN teaches wherein the plurality of sensors includes a temperature sensor configured to generate a temperature sensor output indicative of a sensed expandable balloon temperature, and the plurality of ablation metrics includes an expandable balloon temperature at a prescribed time of the ablation phase, and wherein the target ablation metric is a target sensed expandable balloon temperature at the prescribed time ([0012]-[0015], [0021]-[0029], [0071]-[0073], [0079]-[0080] and Figs. 1-8).
Regarding Claim 13, SHEN teaches wherein the plurality of ablation metrics includes a lowest expandable balloon temperature during the ablation phase, and wherein the target ablation metric is a target lowest sensed expandable balloon temperature during the ablation phase ([0007]-[0011], [0018]-[0020], [0064]-[0067] and [0080]).
Regarding Claim 15, SHEN teaches further comprising a user interface configured to receive, from a user, selected values for each target ablation metric (“On the other hand, the input field provided on the display device can receive the preset balloon temperature from the operator, and the system then compares the preset balloon temperature value with the comparative temperature value” [0037] and [0062]).
Regarding Claim 16, SHEN teaches wherein the graphical display is configured to display, based on an output from the controller, a target ablation metric graph based on one or more of the target ablation metrics over time for the duration of the ablation phase ([0012]-[0017], [0021]-[0024], [0037], [0061]-[0062] and [0080]).
Regarding Claim 17, SHEN teaches wherein the target ablation metric graph is based on the one or more target ablation metrics and a pre-determined tolerance (lower and upper limits or threshold range [0018]-[0019], [0070]-[0072]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794