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 .
Response to Amendment
The amendment filed 15 June 2026 has been entered. Claims 1, 11, 14, and 26 are currently amended. Claims 7, 9-10, 17, 19-20, and 24-25 were previously canceled. Claims 1-6, 8, 11-16, 18, 21-23, and 26-27 are pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 8, 11, 14, 18, 21-23, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Henchie et al. (WO 2021091991), hereinafter Henchie, in view of Gutbrod et al. (US PGPub No. 2021/0369341), hereinafter Gutbrod, and further in view of Hodorek et al. (US PGPub No. 2007/0239153), hereinafter Hodorek.
Regarding claims 1 and 11, Henchie teaches a method and system for ablating a region of a patient organ using electrodes selected from an array of electrodes of an expandable catheter (par. 0022: “catheter device 101 may include a distal portion 102, a proximal elongate 105, and one or more electrodes 103 positioned on a surface of distal portion 102. […] Distal portion 102 may be an expandable or inflatable body”)
that is inserted into the organ (par. 0021: “Catheter device 101 is configured to move through a body lumen of a patient”), the method and system comprising:
an interface (Fig. 1: control unit 112 and display 116), which is configured to:
track location of the catheter with a three-dimensional location system that is configured for tracking manual manipulation of the catheter within the organ of the patient (par. 0025: “Scanner 106 may be a three dimensional computed tomography (CT) scanner, an ultrasound scanner, or any other type of scanner for scanning a patient’s anatomy, taking images of a patients anatomy, and/or storing images of a patient’s anatomy. Scanner 106 may be configured to image a treatment zone within a body of a patient, and output images to control unit 112 for display. In some examples, scanner 106 may be configured to detect catheter device 101 as catheter device 101 moves through a patient’s body”);
display an anatomical map of an organ of a patient (par. 0027: “The user may then display, using control unit 112 and display 116, the three-dimensional images of the patient’s anatomy via a graphical user interface (GUI)”),
wherein the anatomical map is registered with the three-dimensional location system (par. 0030: “The user may monitor the positioning of distal portion 102 using scanner 106, and may visualize via display 116 the positioning of distal portion 102 within the patient’s body”);
receive, from a user, graphical selection of an area on the anatomical map of a target tissue intended to be ablated in an organ of a patient and having a predefined pattern (par. 0027: “Once the treatment zone is identified in the images, the user may then select, using the GUI, an approximate volume of tissue for treatment (e.g. an approximate volume of tissue shown in the images to ablate)”), and an energy level of an ablation signal intended to be applied to the target tissue (par. 0044: “a user may selectively ablate tissue and specifically regulate power applied to a plurality of electrodes positioned at a treatment zone”);
and a processor (Fig. 1: control unit 112), which is configured to:
identify one or more ablation electrodes of the array that overlap the area graphically indicated based on registration of the map with the 3D location system (par. 0029: “Once the user has selected the treatment zone and the control unit 112 has calculated a volume of tissue to ablate, control unit 112 may calculate an ablation plan. An ablation plan may be a surgical plan for how to use system 100, and specifically catheter device 101, to ablate the treatment zone by specifying specific electrodes 103 of catheter device 101 to activate and specific amounts of electrical energy to be applied to each electrode once distal portion 102 is positioned proximate to or at the treatment zone […] the ablation plan may include instructions to activate a specific group of electrodes 103 in order to create a shaped ablation zone that targets unhealthy tissue of the treatment zone”);
and control a generator (Fig. 1: power generator 110) to selectively apply a pre-defined ablation signal to the target tissue using the one or more electrodes identified, wherein the pre-defined ablation signal defines an energy level that is intended to be applied to the target tissue (par. 0031: “control unit 112 may activate power generator 110 and supply a specific group of electrodes 103 with energy at a predetermined power and voltage limit setting”).
Henchie does not explicitly teach displaying the anatomical map concurrently with displaying the tracking location of the catheter and identifying concurrent overlap of the electrodes with the area graphically indicated based on registration of the anatomical map with the 3D location system.
However, in an analogous art, Gutbrod teaches an ablation system and method comprising displaying the anatomical map concurrently with tracking location of the catheter (Fig. 4A and par. 0084: “the EAM system 70 generates the anatomical map of the heart and utilizes location information for the catheter 300 to generate and display, via the display 92, a detailed three-dimensional geometric anatomical map or representation of the cardiac chambers of the heart and the catheter 300, including the location of the electrodes 314 and 316 in relation to the cardiac tissue 302”)
and identifying concurrent overlap of electrodes with a target area (Figs. 4A-4D and par. 0089: “the console 130 generates a graphical representation of the electric field of interest and overlays the graphical representation of the electric field on the anatomical map of the heart, which is displayed on a display, such as display 92. […] In embodiments, the graphical representation and the anatomical map are three-dimensional representations;” examiner notes that some electrodes 314 and 316 overlap with cardiac tissue 302)
as a means to improve planning procedures for ablation by visualizing ablation areas (par. 0083: “To aid in planning and to improve planning procedures for ablation by electroporation, the console 130 is configured to: determine the location of the electrodes 314 and 316 in the patient in relation to the cardiac tissue 302, after the catheter 300 has been inserted into the patient; […] generate a graphical representation of the electric field of interest; and overlay the graphical representation of the electric field on an anatomical map of the heart”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method and system of Henchie by displaying the anatomical map concurrently with tracking location of the catheter and identifying concurrent overlap of the electrodes with the target area, as taught by Gutbrod, in order to improve planning procedures for ablation, as taught by Gutbrod.
Henchie further does not explicitly teach terminating the pre-defined ablation signal applied by the one or more electrodes in response to detecting that the catheter moved to a portion of the target tissue outside the area selected by the user, using the registration of the anatomical map with the 3D location system.
However, in an analogous art, Hodorek teaches a method of using a non-mechanical surgical instrument (Fig. 8: steps 106-110) comprising terminating an energy signal applied by the instrument in response to detecting that the instrument moved to a portion of target tissue outside the area selected by a user, using the registration of an anatomical map with a 3D location system (par. 0030: “"the volume, area, location, etc. of workspace 60 having an infinite number of sizes and/or shapes may be manually determined with a probe, e.g., hand drawn around the localized surgical area;” par. 0042: "In step 118, if the surgeon moves instrument 75 outside the bounds of workspace 60, or, if workspace 60 is a volume, beyond the three-dimensional boundary of workspace 60, e.g., instrument 75 deviates from workspace 60, computer 23 immediately de-energizes alternative energy source 80"). Hodorek teaches that this control structure eliminates the potential for damage to surrounding tissue (par. 0042: "Advantageously, upon de-energization, all emission of energy from tip 77 is immediately terminated to eliminate the potential for surrounding bone or tissue to be contacted or otherwise exposed to energy emitted from tip 77 after alternative energy source 80 is de-energized").
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the system and method of Henchie by terminating the pre-defined ablation signal in response to detecting that the catheter moved outside a user-defined workspace area, as taught by Hodorek, in order to eliminate the potential for damage to surrounding tissue, as taught by Hodorek.
Regarding claims 4 and 14, the combination teaches the method and system of claims 1 and 11 as described previously. Henchie further teaches wherein the area selected by the user includes a first section and a second section, wherein the first section is distinct from the second section (Fig. 2B: first and second sections of ablation zone 220), and wherein the one or more ablation electrodes identified comprise at least a first ablation electrode for producing a first lesion that covers the first section and at least a second ablation electrode for producing a second lesion that covers the second section (par. 0034: “Each portion of ablation zone 220 may be created by a different grouping of electrodes 203 of distal portion 202”).
Regarding claims 8 and 18, the combination teaches the method and system of claims 4 and 14 as described previously. Henchie teaches further comprising selectively applying a first pre-defined ablation signal defining a first energy level to the first section, and a second pre-defined ablation signal defining a second energy level to the second section, the first energy level being other than the second energy level, wherein the processor is configured to receive a first energy level of a first ablation signal intended to be applied to the first section, and a second energy level of a second ablation signal intended to be applied to the second section (Fig. 3: distal section 331 and proximal section 333 of treatment zone 330; par. 0038: “A distal section 331 of treatment zone 330 requires a different depth and shape of ablation compared to intermediate section 332 and proximal section 333 of treatment zone 330. By regulating the amount of energy applied to each electrode 303 and moving catheter device 301 within lumen 345, a user may create an ablation pattern that aligns with treatment zone 330 and targets tissue of treatment zone 330 without damaging tissue adjacent to treatment zone 330. FIG. 3 depicts an example of an irregularly shaped treatment zone. The ability to selectively activate and adjust the energy omitted from a plurality of electrodes 303 of catheter device 301 provides the benefit of adjusting ablation patterns based on the user’s and patient’s needs;” par. 0044: “a user may selectively ablate tissue and specifically regulate power applied to a plurality of electrodes positioned at a treatment zone”).
Regarding claims 21 and 23, the combination teaches the method and system of claims 1 and 11 as described previously. Gutbrod further teaches monitoring the location of a sensor at a distal end of a shaft of the catheter with a three-dimensional location system (par. 0060: “The EAM system 70 generates a localization field, via the field generator 80, to define a localization volume about the heart 30, and one or more location sensors or sensing elements on the tracked device(s), e.g., the electroporation catheter 105, generate an output that can be processed by the mapping and navigation controller 90 to track the location of the sensor, and consequently, the corresponding device, within the localization volume;” Fig. 3 and par. 0083: “the console 130 is configured to: determine the location of the electrodes 314 and 316 in the patient;” examiner interprets a location sensor to determine the location of the electrodes 314 and 316, which are distal to the catheter shaft 308, as at a distal end of a shaft of the catheter),
together with an impedance-based active current location system to determine the location of each electrode in the array (par. 0061: “impedance tracking methodologies may be employed to track the locations of the various devices. In such embodiments, the localization field is an electric field generated, for example, by an external field generator arrangement, e.g., surface electrodes, by intra-body or intra-cardiac devices, e.g., an intracardiac catheter, or both. In these embodiments, the location sensing elements can constitute electrodes on the tracked devices that generate outputs received and processed by the mapping and navigation controller 90 to track the location of the various location sensing electrodes within the localization volume” and par. 0062: “the EAM system 70 is equipped for both magnetic and impedance tracking capabilities”).
To modify the method and system of the combined reference with the location sensor and impedance-based active current location system of Gutbrod would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, because one of ordinary skill in the art would have recognized that applying the known technique taught by Gutbrod (namely, combined magnetic and impedance tracking based on location sensors) to the method and system of the combined reference would have yielded predictable results and resulted in an improved method and system, namely, a method and system that is capable of accurate location tracking without requiring large imaging devices such as a CT scanner.
Regarding claim 22, the combination teaches the method of claim 1 as described previously. Henchie further teaches wherein the pre-defined ablation signal is one or more of an RF ablation signal and an irreversible electroporation ablation signal (par. 0021: “Catheter device 101 may be used for radiofrequency ablation”).
Regarding claims 26-27, the combination teaches the method and system of claims 1 and 11 as described previously. Henchie further teaches wherein the processor is further configured to: based on detecting that the catheter moved, identify another one or more ablation electrodes of the array that do concurrently overlap the area; and control the generator to selectively apply the pre-defined ablation signal using the another one or more ablation electrodes identified (par. 0031: “catheter device 101 may be moved after an initial shaped ablation is applied to the treatment zone, and then control unit 112 may supply a different, specifically selected group of electrodes 103 with a predetermined amount of energy”).
Claims 2-3 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Henchie in view of Gutbrod and Hodorek, and further in view of Schneider et al. (US PGPub No. 2010/0168738), hereinafter Schneider.
Henchie in view of Gutbrod and Hodorek teaches the method and system of claims 1 and 11 as described previously but does not explicitly teach wherein the processor is configured to: (i) monitor a cumulative energy of the ablation signal applied to the target tissue, an ablation power of the ablation signal, and a time interval of applying the ablation signal to the target tissue using the one or more ablation electrodes identified, and (ii) in response to detecting that the cumulative energy exceeds the energy level, terminate the ablation signal to the one or more ablation electrodes identified.
However, in an analogous art, Schneider teaches an ablation system wherein the processor is configured to (i) monitor a cumulative energy of the ablation signal applied to the target tissue, an ablation power of the ablation signal, and a time interval of applying the ablation signal to the target tissue using the one or more selected ablation electrodes (par. 0043: “The ablation system also generally includes a power monitoring device 500 that is configured to monitor the amount of ablation power that is delivered by the ablation catheter (e.g., by ablation element 100), [and] a clock 600 that is configured to measure a time period during which ablative power is delivered to the tissue being treated”), and (ii) in response to detecting that the cumulative energy exceeds the energy level, terminate the ablation signal to the one or more selected ablation electrodes (par. 0043: “a lesion analysis processor 850 that is configured to estimate lesion formation. In estimating lesion formation, lesion analysis processor 850 may make use of: (1) an output of anemometer 200 that provides information on surface perfusion; (2) an output of contact assessment device 120 (e.g., a force sensor output); (3) an output of clock 600; (4) an output of power monitoring device 500; (5) tissue thickness; (6) internal perfusion; and (7) any combinations thereof” and par. 0044: “The ablation system may also include a controller 800 coupled to power source 400 and lesion analysis processor 850 such that controller 800 can regulate power source 400 based on information provided by lesion analysis processor 850. Generally speaking, controller 800 estimates size and/or quality of the lesion being formed and controls power source 400 accordingly. For example, controller 800 may deactivate power source 400 when the estimated lesion size exceeds a target size”).
In light of Schneider’s teaching that lesion formation may be estimated by monitoring the amount of delivered ablation power and the time interval of applying the ablation signal, and that a controller can be configured to deactivate power when lesion formation is determined to be complete, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method and system of the combined reference by incorporating the monitoring features taught by Schneider, in order to estimate lesion formation, as taught by Schneider. Additionally, as taught by Schneider, it would have been obvious to one of ordinary skill in the art to provide a shut-down feature when treatment is determined to be complete.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Henchie in view of Gutbrod and Hodorek, and further in view of Reinders et al. (US PGPub No. 2019/0269367), hereinafter Reinders.
Henchie in view of Gutbrod and Hodorek teaches the method and system of claims 4 and 14 as described previously but does not teach further verifying that a contact force between the one or more selected ablation electrode and the target tissue is larger than a force threshold, wherein applying the ablation signal comprises verifying that the at least first ablation electrode is positioned on the first section and the at least second ablation electrode is positioned on the second section, and subsequently, verifying that the contact force between: (i) the first ablation electrode and the first section, and (ii) the second ablation electrode and the second section, is larger than the force threshold.
However, in an analogous art, Reinders teaches wherein the processor is configured to verify that a contact force between the selected ablation electrodes and the target tissue is larger than a force threshold, wherein the processor is configured to verify that the first ablation electrode is positioned on the first section and the second ablation electrode is positioned on the second section (par. 0136: “the mapping procedure may include mapping varying degrees of contact between various ones of the transducers (e.g., electrodes) and a tissue surface of a bodily cavity into which the transducers are located”), and subsequently, to verify that the contact force between: (i) the first ablation electrode and the first section, and (ii) the second ablation electrode and the second section, is larger than the force threshold (par. 0183: “Another example of not-activation-ready transducers includes those that have insufficient contact with tissue to properly ablate or acquire tissue characteristics, as determined, for example, according to measurements (e.g., various electrical, force, or pressure measurements) represented in the transducer data;” examiner notes that the limitation of verifying that a contact force is larger than a force threshold is met by Reinders’ teaching of determining transducers as not-activation-ready based on force measurements indicating insufficient contact).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method and system of the combined reference by providing means for verifying sufficient contact between the electrodes and tissue, as taught by Reinders, so that electrodes with insufficient contact can be identified as not ready for activation, as taught by Reinders.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Henchie in view of Gutbrod, Hodorek, and Reinders, and further in view of Swanson et al. (US Patent No. 6,183,468), hereinafter Swanson.
Henchie in view of Gutbrod, Hodorek, and Reinders teaches the method and system of claims 5 and 15 as described previously but does not explicitly teach wherein, in response to detecting that the contact force between the at least first ablation electrode and the first section is smaller than the force threshold, the processor is configured to terminate the ablation signal to the at least first ablation electrode.
However, in an analogous art, Swanson teaches terminating an ablation signal to an electrode when it is detected that the electrode has lost contact with tissue (col 7, line 66 – col 8, line 4: “When processor 102 senses that the electrodes 115 have lost contact with tissue or are no longer in close enough proximity for efficacious treatment, power to the electrodes is reduced (but not completely cut-off). Power may either be reduced to all of the electrodes, or only to those electrodes that have lost contact with tissue;” examiner notes that although Swanson does not teach completely cutting off power, reducing the power level below that required for ablation is still interpreted as terminating the ablation signal), which is taught as an improvement on a known safety feature in conventional ablation systems (col 2, lines 34-42: “When the coagulation electrode is pulled away from tissue or efficacious contact is lost, the load is removed, and the voltage output of the power circuit may change. Voltage may rise suddenly, which can cause problems when the electrode is reintroduced into contact with tissue, such as arcing or charring. As a safety consideration, the circuit in conventional systems is powered off for a predetermined period by turning off the power to the RF coagulation electrode when contact is lost”).
It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method and system of the combined reference by terminating the ablation signal when it is detected that an electrode has lost contact with tissue, as taught by Swanson, since Swanson teaches that this control feature is known in the art as a safety consideration in conventional ablation systems.
Response to Arguments
Applicant’s arguments, filed 15 June 2026, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hodorek. As described previously, Hodorek teaches terminating the energy supplied to a surgical instrument in response to detecting that the catheter moved to a portion of target tissue outside an area selected by a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cohen et al. (US PGPub No. 2011/0105954) teaches monitoring a planned and targeted ablation procedure and shutting off the system if there is any deviation from the planned procedure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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