Prosecution Insights
Last updated: May 29, 2026
Application No. 18/638,637

Steam Pop (SP) Safety Early Warning and Control System for Radio Frequency Catheter Ablation (RFCA)

Non-Final OA §101§103§112
Filed
Apr 17, 2024
Priority
Dec 12, 2023 — CN 2023116986221
Examiner
RHODES, NORA W
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Chengdu Megain Technology Co. Ltd.
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
2y 1m
Est. Remaining
78%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
50 granted / 97 resolved
-18.5% vs TC avg
Strong +26% interview lift
Without
With
+26.2%
Interview Lift
resolved cases with interview
Typical timeline
4y 2m
Avg Prosecution
27 currently pending
Career history
156
Total Applications
across all art units

Statute-Specific Performance

§103
96.2%
+56.2% vs TC avg
§102
1.8%
-38.2% vs TC avg
§112
0.8%
-39.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 97 resolved cases

Office Action

§101 §103 §112
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 Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: information acquisition module in claims 1-3 and 7; analysis module in claims 1, 3, and 6-7; control module in claims 1 and 6-7; input unit in claim 2, automatic acquisition unit in claim 2, information generating unit in claim 2, sample acquisition unit in claim 3, parameter screening unit in claim 3, SP event prediction unit in claim 3, curve cluster generation unit in claim 3, first relationship determining unit in claim 6, control signal generation unit in claim 6, second relationship determining unit in claim 6, and risk determining unit in claim 6. The units do appear to lean more toward hardware vs hardware associated with software as seen in [0027] and [0082]. Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 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. Claim limitations “information acquisition module” in claims 1-3 and 7; “analysis module” in claims 1, 3, and 6-7; “control module” in claims 1 and 6-7; “input unit” in claim 2, “automatic acquisition unit” in claim 2, “information generating unit” in claim 2, “sample acquisition unit” in claim 3, “parameter screening unit” in claim 3, “SP event prediction unit” in claim 3, “curve cluster generation unit” in claim 3, “first relationship determining unit” in claim 6, “control signal generation unit” in claim 6, “second relationship determining unit” in claim 6, and “risk determining unit” in claim 6 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim for all of these claim limitations. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. 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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-7 recites “an analysis module connected to the information acquisition module and configured to determine a main parameter combination standard and an auxiliary standard for terminating ablation based on the ablation point database of the SP events in history, and generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard; and a control module connected to the analysis module and the ablation device, configured to compare the ablation parameter indexes during the radiofrequency ablation and the termination curve cluster to generate an early warning and control signal, and configured to control an ablation mechanism in the ablation device based on the early warning and control signal”. This judicial exception is not integrated into a practical application because comparing values is an abstract idea and the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations only control a device based on a warning and control signal, which is a well-understood, routine, conventional computer function as recognized by the court decisions listed in MPEP § 2106.05(d). 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 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al., US 20200022649, herein referred to as “Rodriguez”, in view of Tsoref et al., US 20220008126, herein referred to as “Tsoref”, further in view of Tamby et al., US 20230233545, herein referred to as “Tamby”. Regarding claim 1, Rodriguez discloses a steam pop (SP) safety early warning and control system for radiofrequency catheter ablation (RFCA) (Figure 1A: catheter 116 and Figures 14A-B and [0393] and [0147]), comprising: an information acquisition module connected to an ablation device and configured to obtain baseline information (Figure 1A: sensor interface 1126), an ablation point database of SP events in history (Figure 1A: data repository 1108 and [0213]), and ablation parameter indexes during radiofrequency ablation, wherein the baseline information comprises: age, gender, height, and weight ([0125] and [0272]); the ablation parameter index comprises: an ablation catheter type ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements … and/or to identify the type of the catheter.”), an impedance curve of ablation points ([0160] and [0212]-[0213]), impedance stability ([0212]-[0213] and [0260]: “Differences in impedance as a function of these field parameters may be analyzed to isolate impedance effects arising from tissue regions near the electrode.”), a pressure curve ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.”), pressure stability ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.”), a temperature curve ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.” And [0200]), an ablation time ([0025]), power ([0025]), and anatomical characteristics of the ablation points ([0180] and [0447] and [0260]); an analysis module (Figure 1A: computing unit 1102) connected to the information acquisition module and configured to determine a main parameter combination standard and an auxiliary standard for terminating ablation based on the ablation point database of the SP events in history ([0412] and [0393] and [0486]), and generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard ([0213] and Figure 9 and [0237); and a control module (Figure 1A: processor 1104) connected to the analysis module and the ablation device, configured to compare the ablation parameter indexes during the radiofrequency ablation and the termination curve cluster to generate an early warning and control signal ([0393]-[0396]), and configured to control an ablation mechanism in the ablation device based on the early warning and control signal (Figure 12). Rodriguez does not explicitly disclose an SP safety early warning and control system wherein the ablation parameter index comprises: a respiration curve, respiration stability, a heartbeat curve, heartbeat stability, a perfusion volume, and an ablation index (AI) value. However, Tsoref teaches a system wherein the ablation parameter index comprises: a respiration curve ([0141]), respiration stability ([0141] and [0150]), and an ablation index (AI) value ([0153]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rodriguez so that the ablation parameter index comprises a respiration curve, respiration stability, and an ablation index (AI) value as taught by Tsoref so that the system learns which inputs are most important and which are less and thus can suggest an ablation location or an ablation strategy (Tsoref [0156]). Further, Tamby teaches a system wherein the ablation parameter index comprises: a heartbeat curve ([0270]), heartbeat stability ([0270]), and a perfusion volume ([0024]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rodriguez so that the ablation parameter index comprises a heartbeat curve, heartbeat stability, and a perfusion volume as taught by Tamby so that electrical stimulation is only triggered when a patient’s vital signs are within a specific range (Tamby [0270]). Regarding claim 2, Rodriguez in view of Tsoref and Tamby discloses the SP safety early warning and control system for RFCA according to claim 1, and Rodriguez further discloses a system wherein the information acquisition module (Figure 1A: sensor interface 1126) comprises: an input unit configured to input the baseline information (Figure 1A: sensors 1128 and data interface 1118); an automatic acquisition unit connected to the ablation device ([0212]) and configured to obtain the ablation catheter type ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements … and/or to identify the type of the catheter.”), impedance of the ablation points ([0160] and [0212]-[0213]), a pressure ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.”), a temperature ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.” And [0200]), the ablation time ([0025]), and the power ([0025]); and an information generating unit connected to the automatic acquisition unit ([0171]) and configured to determine the impedance curve of the ablation points ([0160] and [0212]-[0213]), the impedance stability ([0212]-[0213] and [0260]: “Differences in impedance as a function of these field parameters may be analyzed to isolate impedance effects arising from tissue regions near the electrode.”), the pressure curve ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.”), the pressure stability ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.”), the temperature curve ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.” And [0200]), and the anatomical characteristics of the ablation points based on data obtained by the automatic acquisition unit ([0180] and [0447] and [0260]), so as to obtain the ablation parameter indexes during the radiofrequency ablation (Figures 14A-B and Figure 12). Tsoref further discloses a system wherein an automatic acquisition unit is configured to obtain a respiration volume ([0141]) and the AI value ([0153]); and an information generating unit is configured to determine the respiration curve ([0141]) and the respiration stability ([0141] and [0150]). Tamby further discloses a system wherein an automatic acquisition unit is configured to obtain the heartbeat ([0270]) and the perfusion volume ([0024]); and an information generating unit is configured to determine the heartbeat curve ([0270]) and the heartbeat stability ([0270]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rodriguez so that the ablation parameter index comprises a respiration curve, respiration stability, and an ablation index (AI) value as taught by Tsoref so that the system learns which inputs are most important and which are less and thus can suggest an ablation location or an ablation strategy (Tsoref [0156]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rodriguez so that the ablation parameter index comprises a heartbeat curve, heartbeat stability, and a perfusion volume as taught by Tamby so that electrical stimulation is only triggered when a patient’s vital signs are within a specific range (Tamby [0270]). Regarding claim 3, Rodriguez in view of Tsoref and Tamby discloses the SP safety early warning and control system for RFCA according to claim 1, and Rodriguez further discloses a system wherein the analysis module comprises: a sample acquisition unit connected to the information acquisition module (Figure 1A: data repository 1108), and configured to obtain ablation point data of the SP events in history ([0125]), and allow the ablation point data to fall into an SP+ group and a SP- group according to whether an SP event occurs during ablation ([0393] and [0125]); a parameter screening unit connected to the sample acquisition unit (Figure 1A: computing unit 1102), and configured to respectively screen distinguishing parameters of SP events from the SP+ group and the SP- group by using a statistical method (Figure 14A: observed segment effectiveness 2102 and [0393]-[0394]); an SP event prediction unit connected to the parameter screening unit, and configured to perform receiver operating characteristic (ROC) analysis on the distinguishing parameters of the SP events to obtain sensitivity, specificity, a negative predictive value and a positive predictive value of each distinguishing parameter for predicting SP events (Figure 14A: observed segment effectiveness 2102 and [0393]-[0394]); and a curve cluster generation unit connected to the SP event prediction unit, and configured to use distinguishing parameters with the sensitivity reaching 100% and the specificity reaching a set threshold as the main parameter combination standard ([0394] and [0396]), use other remaining distinguishing parameters as the auxiliary standard, and generate a termination curve cluster corresponding to the main parameter combination standard and the auxiliary standard (Figure 14A: observed segment effectiveness 2102 and [0393]-[0394] and [0405]-[0407]). Regarding claim 4, Rodriguez in view of Tsoref and Tamby discloses the SP safety early warning and control system for RFCA according to claim 3, and Rodriguez further discloses a system wherein the main parameter combination standard ([0394] and [0396]) comprises the ablation catheter type ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements … and/or to identify the type of the catheter.”), the impedance curve of the ablation points ([0160] and [0212]-[0213]), the pressure curve ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.”), the temperature curve ([0171]: “The intercepted signals may be analyzed by system 1100, for example, to perform real-time tissue measurements (e.g., contact force, pressure, ablated volume and/or depth, temperature, and/or fibrosis mapping), to perform localization of the catheter, to estimate ablation treatment effectiveness and/or to identify the type of the catheter.” And [0200]), the ablation time ([0025]), a stability parameter ([0445]: “For example, temperature measured at an ablation probe tip which rises and maintains stability during ablation is potentially an indication of successful ablation, while a temperature which drops is potentially and indication of less likely success.”, and the anatomical characteristics of the ablation points ([0180] and [0447] and [0260]). Regarding claim 5, Rodriguez in view of Tsoref and Tamby discloses the SP safety early warning and control system for RFCA according to claim 3, and Tsoref further discloses a system wherein the auxiliary standard comprises the respiration curve ([0141]) and the respiration stability ([0141] and [0150]), while Tamby discloses a system wherein the auxiliary standard comprises the heartbeat curve ([0270]), the heartbeat stability ([0270]), and the perfusion volume ([0024]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rodriguez so that the auxiliary standard comprises the respiration curve and respiration stability as taught by Tsoref so that the system learns which inputs are most important and which are less and thus can suggest an ablation location or an ablation strategy (Tsoref [0156]). It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Rodriguez so that the auxiliary standard comprises the heartbeat curve, heartbeat stability, and the perfusion volume as taught by Tamby so that electrical stimulation is only triggered when a patient’s vital signs are within a specific range (Tamby [0270]). Regarding claim 6, Rodriguez in view of Tsoref and Tamby discloses the SP safety early warning and control system for RFCA according to claim 1, and Rodriguez further discloses a system wherein the control module comprises: a first relationship determining unit connected to the analysis module and configured to obtain the main parameter combination standard in the ablation parameter indexes during the radiofrequency ablation and determine a relationship between the main parameter combination standard and each curve in the termination curve cluster ([0320] and [0412] and [0536]: “Optionally, a physician can set any desired threshold or other function for these effects, based on their own preferences (which may be based on their own style of ablation, tolerance for uncertainty of result in the estimator output, assessment of patient risk, etc.),”), wherein the termination curve cluster corresponding to the main parameter combination standard comprises a first warning line and a second warning line ([0320]); an early warning and control signal generation unit connected to the first relationship determining unit and the ablation device, and configured to generate an ablation mechanism stop signal when the main parameter combination standard reaches the first warning line ([0320]), or generate an ablation mechanism early warning signal when the main parameter combination standard reaches the second warning line (Not actively claimed), wherein the ablation mechanism stop signal is used to control the ablation device to stop operating ([0486]); and the ablation mechanism early warning signal is used to control the ablation device to stop operating after operating for a set time ([0535]: “Optionally, constants of the sigmoid are set so that lag phase ends at about 1 minute 2 minutes after ablation, 3 minutes after ablation, 5 minutes after ablation 8 minutes after ablation, 10 minutes after ablation, or another longer, shorter or intermediate time after ablation.”); a second relationship determining unit connected to the analysis module and configured to obtain the auxiliary standard in the ablation parameter indexes during the radiofrequency ablation and determine a relationship between the auxiliary standard and the termination curve cluster ([0320] and [0412] and [0536]: “Optionally, a physician can set any desired threshold or other function for these effects, based on their own preferences (which may be based on their own style of ablation, tolerance for uncertainty of result in the estimator output, assessment of patient risk, etc.),”); and a risk determining unit connected to the second relationship determining unit (Figure 12: block 138 and Figure 14B: effectiveness criteria 2210), and configured to retrieve the baseline information and the ablation parameter indexes during the radiofrequency ablation by the analysis module when the auxiliary standard reaches the termination curve cluster ([0477]), and determine whether there is a risk of occurrence of an SP event based on the baseline information and the ablation parameter indexes during the radiofrequency ablation ([0393]-[0394]), wherein if there is the risk, the ablation mechanism stop signal is generated ([0486] and [0477]), or if there is no risk, the ablation mechanism is continued ([0476]). Regarding claim 7, Rodriguez in view of Tsoref and Tamby discloses the SP safety early warning and control system for RFCA according to claim 1, and Rodriguez further discloses a system wherein the information acquisition module, the analysis module and the control module are integrally arranged in an upper computer or a controller (Figure 1A: sensors 1128, sensor interface 1126, computing unit 1102, and processors 1104); and the upper computer or the controller is connected to the ablation device (Figure 1A: connector 1140 and catheter 1116. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NORA W RHODES/Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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Prosecution Timeline

Apr 17, 2024
Application Filed
May 06, 2026
Non-Final Rejection mailed — §101, §103, §112 (current)

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1-2
Expected OA Rounds
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4y 2m (~2y 1m remaining)
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