DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s Amendment filed March 17, 2026 (hereinafter “03/17/26 Amendment") has been entered, and fully considered. In the 03/17/26 Amendment, claims 1, 12, 13, & 22 were amended, & claims 2 & 15 were cancelled. No claims were newly added. Therefore, claims 1, 3-14, & 16-22 are now pending in the application.
3. The rejections under § 103 previously set forth in the Non-Final Office Action mailed 12/18/25 (“12/18/25 Action”) have been updated responsive to Applicant’s amendment, and maintained.
4. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Rejections - 35 USC § 103
5. 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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. Claims 1, 3-7, 11-14, & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0133911 to Batchelor et al. ("Batchelor") in view of U.S. Patent Application Publication No. 2012/0323237 to Paul et al. ("Paul"), and further in view of U.S. Patent Application Publication No. 2014/0276771 to Miller et al. ("Miller ‘771").
8. Regarding claim 1, Batchelor teaches an ablation system comprising:
an ablation probe [probe (422) - ¶’s [0163], [0184]; FIG. 6S] comprising:
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FIG. 6S of BATCHELOR
an elongated body [probe (422) has an elongated body - FIG. 6S] having a tapered distal end [(424)] and a proximal end [proximal end (432)] that are aligned along an axis [longitudinal axis of probe (422) - FIG. 6S];
first and second electrical sensors disposed on the elongated body [sensing electrode (446S) and sensing electrode (444S) - ¶[0184]; FIG. 6S]; and
an electrode [ablation electrode (440S) - ¶[0184]; FIG. 6S] disposed on the elongated body [(422)] between the first and second electrical sensors [(446S, 444S)] [clearly shown in FIG. 6S];
a power source electrically coupled to the first and second electrical sensors and to the electrode [implicit through the energization of the sensing electrodes and ablation electrode - see, e.g., ¶[0227] (“the method may include delivering a source ablation signal from an ablation electrode (such as one of the electrodes in one of the systems 20A, 120A, 220A, 320A, 420A, 520A, 620A). Typically, the ablation electrode is provided on a probe, as described above. For example, the method may also include delivering a source ablation signal from an ablation electrode (which could be the first electrode or another electrode) when the ablation electrode is energized, the source ablation signal being configured to pass through tissue and become an ablation return signal, the method may further comprise receiving the ablation return signal through an ablation return electrode of the system”); and ¶[0230] (“The measurement circuit may operate the same way. The measurement electrodes and the ablation electrodes may be common or different electrodes. For example, when two electrodes are energized with opposite polarity in the measurement circuit, a first measurement source signal is delivered from a first sensing electrode, and a second measurement source signal is delivered from a second sensing electrode”)];
[the system configured to]:
analyze an electrical characteristic [impedance] measured by the first and second electrical sensors [see, e.g., ¶’s [0221], [0230], [0233] (“The measurement circuit may provide data for manipulation, and once the data is manipulated, for example, the system may determine an impedance in order to make an estimation regarding device positioning or location/condition of the target object”); & [0236]], and
produce an output control signal when the electrical characteristic [impedance] measured by the first and second electrical sensors indicates that the electrode is aligned with a target anatomical feature [e.g., ¶’s [0222] (“The method may further include a step 706 of determining whether the first position of the probe is a desired position of the probe, based on the bulk tissue property and/or the impedance. If the probe is not in a desired position, then probe may then be repositioned. The step 702 of energizing the first electrode with the measurement level of power may then be repeated until it is determined that the probe is in the desired position. The desired position is a position that is desired for ablating tissue in a patient. Based on the impedance determined or the bulk tissue property measured, the operator may estimate whether the probe is in the desired position”); [0233], [0236]].
A. PROCESSOR(S) & MEMORY
While it is the Examiner’s position that the various energization, sensing, ablation, & analysis steps, etc. of Batchelor are controlled by one or more processors, such a teaching is not explicit in Batchelor.
As such, Batchelor does not explicitly teach:
one or more processors having an input electrically coupled to the first and second electrical sensors to receive first and second output signals, respectively, from the first and second electrical sensors;
a non-transitory computer-readable memory operatively coupled to the one or more processors, the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the one or more processors, cause the one or more processors to [perform the “analyz[ing]” and “produc[ing]” steps addressed above].
Paul, in a similar field of endeavor, teaches an electrode catheter and a method for assessing electrode-tissue contact and coupling [e.g., Abstract], and, more particularly, use of a measurement circuit to measure impedance at an electrode-tissue interface [¶[0081]]. Paul further teaches that it was known to use a processor and memory for making determinations based on impedance measurements [see, e.g., ¶[0084] (“measurement circuit 42 may be operatively associated with a processor 50 and memory 52 to analyze the measured impedance”); & FIG. 3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Batchelor such that the system include one or more processors having an input electrically coupled to the first and second electrical sensors to receive first and second output signals, respectively, from the first and second electrical sensors, and a non-transitory computer-readable memory operatively coupled to the one or more processors, the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the one or more processors, cause the one or more processors to perform the claimed “analyz[ing]” and “produc[ing]” steps, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [i.e., a processor to execute software stored in a memory] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. INTERLOCK SWITCH
Finally, the combination of Batchelor and Paul does not teach:
an interlock switch electrically connected to the electrode, the power source, and the one or more processors, the interlock switch having a default open state in which the electrode is electrically disconnected from the power source and a closed state in which the electrode is electrically connected to the power source, the interlock switch configured to transition from the default open state to the closed state in response to the output control signal.
Miller ‘771, in a similar field of endeavor, teaches that it was known in the art to automatically switch on/off power to an ablative member via a controller based on impedance measurements [e.g., ¶’s [0058]-[0059]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor and Paul to include an interlock switch electrically connected to the electrode, the power source, and the one or more processors, the interlock switch having a default open state in which the electrode is electrically disconnected from the power source and a closed state in which the electrode is electrically connected to the power source, the interlock switch configured to transition from the default open state to the closed state in response to the output control signal, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [i.e., providing power to an ablation electrode (using a switch) based on impedance measurements] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
9. Regarding claim 3, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the electrode [(440S)] is aligned with the target anatomical feature when the electrical characteristic [impedance] measured by the first and second electrical sensors [(446S, 444S)] has about the same magnitude [¶’s [0230]-[0233]].
10. Regarding claim 4, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the electrode [(440S)] is aligned with the target anatomical feature when the electrical characteristic [impedance] measured by the first and second electrical sensors indicates that the first and second electrical sensors are in physical contact with the target anatomical feature [¶’s [0113], [0230]-[0233]].
11. Regarding claim 5, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the electrode [(440S)] is aligned with the target anatomical feature when the magnitude of the electrical characteristic [impedance] measured by the first and second electrical sensors [(446S, 444S)] is higher than a respective baseline magnitude [NOTE: broadly, via a comparison to known electrical impedances associated with known tissues - ¶[0113]].
12. Regarding claim 6, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the first electrical sensor [(446S)] is located closer to the tapered distal end [(424)] than the second electrical sensor [(444S)] [clearly shown in FIG. 6S], and
the electrode [(440S)] is aligned with the target anatomical feature when the electrical characteristic [impedance] measured by the first electrical sensor [(446S)] indicates that the first electrical sensor [(446S)] has passed over the target anatomical feature and the electrical characteristic [impedance] measured by the second electrical sensor [(444S)] indicates that the second electrical sensor is not in physical contact with the target anatomical feature [¶’s [0113], [0230]-[0233]].
13. Regarding claim 7, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the electrical characteristic comprises a resistance [e.g., ¶’s [0113], [0114], [0219], [0221]] or an impedance [e.g., ¶’s [0113], [0114], [0219], [0221]].
14. Regarding claim 11, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the first and second electrical sensors [sensing electrode (446S) and sensing electrode (444S)] and the electrode [ablation electrode (440S)] are aligned with respect to the axis [aligned along the longitudinal axis of probe (422) - FIG. 6S].
15. Regarding claim 12, Batchelor teaches a multi-electrode ablation system comprising:
a multi-electrode ablation probe [probe (522) - ¶’s [0187], [0196]; FIG. 7F] comprising:
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FIG. 7F OF BATCHELOR
an elongated body [probe (522) has an elongated body - FIG. 7F] having a tapered distal end [(524)] and a proximal end [proximal end (532)] that are aligned along an axis [longitudinal axis of probe (522) - FIG. 7F];
a plurality of electrical sensors disposed on the elongated body [sensing electrodes (544F), (546F), & (550F) - ¶[0196]; FIG. 7F]; and
a plurality of electrodes disposed on the elongated body [ablation electrodes (538F, 540F) - ¶[0196]; FIG. 7F], the electrodes [(538F, 540F)] and electrical sensors [(544F), (546F), & (550F)] having an alternating arrangement in which each electrode is located between a respective neighboring pair of electrical sensors [as clearly shown in FIG. 7F, electrode (538F) is disposed between sensors (544F 546F), and electrode (540F) is disposed between sensors (546F, 500F)];
one or more power sources electrically coupled to the electrical sensors and the electrodes [implicit through the energization of the sensing electrodes and ablation electrodes - see, e.g., ¶[0227] (“the method may include delivering a source ablation signal from an ablation electrode (such as one of the electrodes in one of the systems 20A, 120A, 220A, 320A, 420A, 520A, 620A). Typically, the ablation electrode is provided on a probe, as described above. For example, the method may also include delivering a source ablation signal from an ablation electrode (which could be the first electrode or another electrode) when the ablation electrode is energized, the source ablation signal being configured to pass through tissue and become an ablation return signal, the method may further comprise receiving the ablation return signal through an ablation return electrode of the system”); and ¶[0230] (“The measurement circuit may operate the same way. The measurement electrodes and the ablation electrodes may be common or different electrodes. For example, when two electrodes are energized with opposite polarity in the measurement circuit, a first measurement source signal is delivered from a first sensing electrode, and a second measurement source signal is delivered from a second sensing electrode”)];
[the system configured to]:
analyze an electrical characteristic [impedance] measured by the electrical sensors [see, e.g., ¶’s [0221], [0230], [0233] (“The measurement circuit may provide data for manipulation, and once the data is manipulated, for example, the system may determine an impedance in order to make an estimation regarding device positioning or location/condition of the target object”); & [0236]], and
produce an output control signal when the electrical characteristic [impedance] measured by the electrical sensors indicates that the electrodes are aligned with a target anatomical feature [e.g., ¶’s [0222] (“The method may further include a step 706 of determining whether the first position of the probe is a desired position of the probe, based on the bulk tissue property and/or the impedance. If the probe is not in a desired position, then probe may then be repositioned. The step 702 of energizing the first electrode with the measurement level of power may then be repeated until it is determined that the probe is in the desired position. The desired position is a position that is desired for ablating tissue in a patient. Based on the impedance determined or the bulk tissue property measured, the operator may estimate whether the probe is in the desired position”); [0233], [0236]].
A. PROCESSOR(S) & MEMORY
While it is the Examiner’s position that the various energization, sensing, ablation, & analysis steps, etc. of Batchelor are controlled by a computer, such a teaching is not explicit in Batchelor.
As such, Batchelor does not explicitly teach:
one or more processors having an input electrically coupled to the electrical sensors to receive respective output signals from the electrical sensors;
a non-transitory computer-readable memory operatively coupled to the one or more processors, the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the one or more processors, cause the one or more processors to [perform the “analyz[ing]” and “produc[ing]” steps addressed above].
Paul, in a similar field of endeavor, teaches an electrode catheter and a method for assessing electrode-tissue contact and coupling [e.g., Abstract], and, more particularly, use of a measurement circuit to measure impedance at an electrode-tissue interface [¶[0081]]. Paul further teaches that it was known to use a processor and memory for making determinations based on impedance measurements [see, e.g., ¶[0084] (“measurement circuit 42 may be operatively associated with a processor 50 and memory 52 to analyze the measured impedance”); & FIG. 3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Batchelor such that the system include one or more processors having an input electrically coupled to the electrical sensors to receive respective output signals from the electrical sensors, and a non-transitory computer-readable memory operatively coupled to the one or more processors, the non-transitory computer-readable memory storing computer-readable instructions that, when executed by the one or more processors, cause the one or more processors to perform the claimed “analyz[ing]” and “produc[ing]” steps, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [i.e., a processor to execute software stored in a memory] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. INTERLOCK SWITCH
Finally, the combination of Batchelor and Paul does not teach:
an interlock switch electrically connected to the electrode, the power source, and the one or more processors, the interlock switch having a default open state in which the electrode is electrically disconnected from the power source and a closed state in which the electrode is electrically connected to the power source, the interlock switch configured to transition from the default open state to the closed state in response to the output control signal.
Miller ‘771, in a similar field of endeavor, teaches that it was known in the art to automatically switch on/off power to an ablative member via a controller based on impedance measurements [e.g., ¶’s [0058]-[0059]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor and Paul to include an interlock switch electrically connected to the electrode, the power source, and the one or more processors, the interlock switch having a default open state in which the electrode is electrically disconnected from the power source and a closed state in which the electrode is electrically connected to the power source, the interlock switch configured to transition from the default open state to the closed state in response to the output control signal, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [i.e., providing power to an ablation electrode (using a switch) based on impedance measurements] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
16. Regarding claim 13, Batchelor teaches a method of ablating a mammalian subject, comprising:
inserting an ablation probe [probe (422) - ¶’s [0163], [0184]; FIG. 6S] into a mammalian subject [Abstract - (“The method may include inserting a probe into a first position in an anatomy of the patient”)], the ablation probe comprising:
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FIG. 6S of BATCHELOR
an elongated body [probe (422) has an elongated body - FIG. 6S] having a tapered distal end [(424)] and a proximal end [proximal end (432)] that are aligned along an axis [longitudinal axis of probe (422) - FIG. 6S];
first and second electrical sensors disposed on the elongated body [sensing electrode (446S) and sensing electrode (444S) - ¶[0184]; FIG. 6S]; and
an electrode [ablation electrode (440S) - ¶[0184]; FIG. 6S] disposed on the elongated body [(422)] between the first and second electrical sensors [(446S, 444S)] [clearly shown in FIG. 6S], wherein:
the first and second electrical sensors [(446S, 444S)] and the electrode [(440S)] are electrically coupled to a power source [implicit through the energization of the sensing electrodes and ablation electrode - see, e.g., ¶[0227] (“the method may include delivering a source ablation signal from an ablation electrode (such as one of the electrodes in one of the systems 20A, 120A, 220A, 320A, 420A, 520A, 620A). Typically, the ablation electrode is provided on a probe, as described above. For example, the method may also include delivering a source ablation signal from an ablation electrode (which could be the first electrode or another electrode) when the ablation electrode is energized, the source ablation signal being configured to pass through tissue and become an ablation return signal, the method may further comprise receiving the ablation return signal through an ablation return electrode of the system”); and ¶[0230] (“The measurement circuit may operate the same way. The measurement electrodes and the ablation electrodes may be common or different electrodes. For example, when two electrodes are energized with opposite polarity in the measurement circuit, a first measurement source signal is delivered from a first sensing electrode, and a second measurement source signal is delivered from a second sensing electrode”)], and
***
[the method including]:
monitoring… an electrical characteristic [impedance] measured by the first and second electrical sensors [see, e.g., ¶’s [0221], [0230], [0233] (“The measurement circuit may provide data for manipulation, and once the data is manipulated, for example, the system may determine an impedance in order to make an estimation regarding device positioning or location/condition of the target object”); & [0236]];
producing… an output control signal when the electrical characteristic [impedance] measured by the first and second electrical sensors indicates that the electrode is aligned with a target anatomical feature [e.g., ¶’s [0222] (“The method may further include a step 706 of determining whether the first position of the probe is a desired position of the probe, based on the bulk tissue property and/or the impedance. If the probe is not in a desired position, then probe may then be repositioned. The step 702 of energizing the first electrode with the measurement level of power may then be repeated until it is determined that the probe is in the desired position. The desired position is a position that is desired for ablating tissue in a patient. Based on the impedance determined or the bulk tissue property measured, the operator may estimate whether the probe is in the desired position”); [0233], [0236]]; and
ablating the target anatomical feature, with the electrode, after the electrode is aligned with the target anatomical feature [e.g., ¶[0223] (“Once the probe is in the desired position, the method may include a step 708 of ablating tissue near the probe by energizing an electrode with an ablation level of power”).
A. COMPUTER & MEMORY
While it is the Examiner’s position that the various energization, sensing, ablation, & analysis steps, etc. of Batchelor are controlled by a computer, such a teaching is not explicit in Batchelor.
As such, Batchelor does not explicitly teach:
the first and second electrical sensors have outputs that are electrically coupled to an input of a computer;
monitoring, with the computer, an electrical characteristic measured by the first and second electrical sensors;
producing, with the computer, an output control signal when the electrical characteristic measured by the first and second electrical sensors indicates that the electrode is aligned with a target anatomical feature;
Paul, in a similar field of endeavor, teaches an electrode catheter and a method for assessing electrode-tissue contact and coupling [e.g., Abstract], and, more particularly, use of a measurement circuit to measure impedance at an electrode-tissue interface [¶[0081]]. Paul further teaches that it was known to use a processor [computer] for making determinations based on impedance measurements [see, e.g., ¶[0084] (“measurement circuit 42 may be operatively associated with a processor 50 and memory 52 to analyze the measured impedance”); & FIG. 3].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Batchelor such that the method include processing operations performed via a computer, or more particularly wherein the first and second electrical sensors have outputs that are electrically coupled to an input of a computer; monitoring, with the computer, an electrical characteristic measured by the first and second electrical sensors; [and] producing, with the computer, an output control signal when the electrical characteristic measured by the first and second electrical sensors indicates that the electrode is aligned with a target anatomical feature, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [i.e., a computer/processor to execute processing operations] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
B. INTERLOCK SWITCH
Finally, the combination of Batchelor and Paul does not teach:
automatically closing an interlock switch in response to the output control signal, the interlock switch electrically connecting the electrode to a power source when the interlock switch is in a closed state.
Miller ‘771, in a similar field of endeavor, teaches that it was known in the art to automatically switch on/off power to an ablative member via a controller based on impedance measurements [e.g., ¶’s [0058]-[0059]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor and Paul to include automatically closing an interlock switch in response to the output control signal, the interlock switch electrically connecting the electrode to a power source when the interlock switch is in a closed state, since such a particular known, control technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Miller ‘771, and one of ordinary skill in the art would have been capable of applying this known technique to the known method of Batchelor/Paul, and the results [controlling power supply to an ablation electrode based on measured impedance] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
17. Regarding claim 14, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Batchelor was modified above (in the rejection of claim 13) to implement the interlock switch of Miller ‘771. Miller ‘771 further teaches automatically applying power to the electrode in response to the output control signal [e.g., ¶’s [0058]-[0059]].
18. Regarding claim 16, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Batchelor (as modified) further teaches:
determining, with the computer, when a magnitude of the electrical characteristic [impedance] measured by the first and second electrical sensors [(446S, 444S)] is higher than the magnitude of a respective baseline output signal of the first and second electrical sensors [¶’s [0230]-[0233]]; and
producing the output control signal when the magnitude of the electrical characteristic [impedance] measured by the first and second electrical sensors [(446S, 444S)] is higher than the magnitude of the respective baseline output signal of the first and second electrical sensors [¶’s [0113], [0230]-[0233]].
19. Regarding claim 17, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Batchelor (as modified) further teaches:
(a) determining, with the computer, when a magnitude of the electrical characteristic [impedance] measured by the first electrical sensor [(446S)] is higher than the magnitude of a baseline output signal of the first electrical sensor [(446S)] and the magnitude of the electrical characteristic measured by the second electrical sensor [(444S)] is about equal to the magnitude of a baseline output signal of the second electrical sensor [(444S)] [¶’s [0113], [0230]-[0233]];
(b) after step (a), determining, with the computer, when the magnitude of the electrical characteristic measured by the first and second electrical sensors [(446S, 444S)] is about equal to the magnitude of the baseline output signals of the first and second electrical sensors [(446S, 444S)], respectively [¶’s [0113], [0230]-[0233]]; and
(c) producing the output control signal when the magnitude of the electrical characteristic [impedance] measured by the first and second electrical sensors [(446S, 444S)] is about equal to the magnitude of the baseline output signals of the first and second electrical sensors [(446S, 444S)], respectively [¶’s [0113], [0230]-[0233]],
wherein the first electrical sensor [(446S)] is located closer to the tapered distal end [(424)] than the second electrical sensor [(444S)] [clearly shown in FIG. 6S].
20. Regarding claims 18 & 19, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 17 for the reasons set forth in detail (above) in the Office Action.
Dependent claims 18 & 19 further include limitations directed to impedance determinations and corresponding probe movements [advancement/retraction]:
[claim 18] (d) advancing the ablation probe distally in the mammalian subject between steps (a) and (b), wherein the ablation probe is in a first position in step (a) and in a second position in step (b).
[claim 19] (e) determining, with the computer, when the magnitude of the electrical characteristic measured by the second electrical sensor is higher than the magnitude of the baseline output signal of the second electrical sensor and the magnitude of the electrical characteristic measured by the first electrical sensor is about equal to the magnitude of the baseline output signal of the first electrical sensor;
[claim 19] (f) advancing the ablation probe distally in the mammalian subject between steps (b) and (e), wherein the ablation probe is in a third position in step (e), the second position between the first position and the third position; and
[claim 19] (g) retracting the ablation probe proximally in the mammalian subject after step (e) to a fourth position, the fourth position between the first position and the third position;
[claim 19] (h) after step (g), repeating step (b),
[claim 19] wherein step (c) occurs after step (h).
While not explicitly taught by the combination of Batchelor, Paul, and Miller ‘771, Batchelor does teach determining whether the probe is in a desired position based on the impedance measurements obtained by the first and second electrical sensors [(446S, 444S)], and then repositioning the probe [advancing/retracting], obtaining new impedance measurements from the first and second electrical sensors [(446S, 444S)], and repeating the process as needed until the probe is in the desired position [e.g., ¶’s [0221], [0222], [0236]]. As such, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor, Paul, and Miller ‘771 to include as many measurement, determination, & re-positioning steps as required until the probe is properly positioned, so as to ensure that the probe is properly placed vis-à-vis the desired target tissue to be ablated in order to prevent any unintended thermal damage to non-targeted tissue that may arise due to incorrect positioning.
21. Regarding claim 20, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Batchelor further teaches wherein the electrical characteristic comprises a resistance [e.g., ¶’s [0113], [0114], [0219], [0221]] or an impedance [e.g., ¶’s [0113], [0114], [0219], [0221]].
22. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Batchelor, Paul, and Miller ‘771, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2011/0166519 to Nguyen et al. ("Nguyen").
23. Regarding claim 8, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Batchelor, Paul, and Miller ‘771 does not, however, teach:
a thermocouple disposed on the elongated body adjacent to the electrode.
Nguyen, in a similar field of endeavor, teaches that it was known to place a temperature sensor (162) (e.g., a thermocouple) on a probe (110) adjacent to an energy delivery coil (120) [see ¶[0108] (“A temperature sensor 162 (e.g., a thermocouple (such as a K-type bifilar thermocouple), thermistor, or the like) is preferably positioned within or adjacent to the coil 120. In the depicted embodiment, the temperature sensor 162 is located about midway along the length of the coil, in a gap formed between adjacent winds of the coil. A pair of leads (not shown in FIG. 3 or 4) are connected to the temperature sensor 162 to provide temperature information to the power supply 210”)]
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor, Paul, and Miller ‘771 to include a thermocouple disposed on the elongated body adjacent to the electrode, since such a modification would allow for the monitoring of temperature at a target site during ablation to prevent unintended thermal damage to, e.g., surrounding, non-target tissue, thereby increasing the overall safety of a procedure.
24. Claims 9 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Batchelor, Paul, and Miller ‘771, as applied to claim 1 above, and further in view of U.S. Patent Application Publication No. 2009/0163904 to Miller et al. ("Miller ‘904").
25. Regarding claims 9 & 10, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Batchelor, Paul, and Miller ‘771 does not, however, explicitly teach:
[claim 9] wherein the first and second electrical sensors comprise band contacts that extend along at least a portion of a perimeter of the elongated body; nor
[claim 10] wherein the band contacts comprise ring contacts that form a respective loop along the perimeter of the elongated body.
Miller ‘904, in a similar field of endeavor, teaches that it was known for sensors/contacts (electrodes) used for diagnostic purposes (including for location determination) to comprise ring electrodes [see ¶[0034] (“Electrodes 12, 50, 52 are provided for a variety of diagnostic and therapeutic purposes including, for example, electrophysiological studies, catheter identification and location, pacing, cardiac mapping and ablation. In the illustrated embodiment, catheter includes an ablation tip electrode 12 at distal end 48 of shaft 44 and a pair of ring electrodes 50, 52. It should be understood, however, that the number, orientation and purpose of electrodes 12, 50, 52 may vary”); note also ¶’s [0042] & [0052] regarding determining impedance].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor, Paul, and Miller ‘771 such that the first and second electrical sensors comprise band contacts that extend along at least a portion of a perimeter of the elongated body, and wherein the band contacts comprise ring contacts that form a respective loop along the perimeter of the elongated body, since such a modification amounts merely to the substitution of one known sensing electrode type for another, yielding predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
26. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Batchelor, Paul, and Miller ‘771, as applied to claim 13 above, and further in view of U.S. Patent Application Publication No. 2012/0143182 to Ullrich et al. ("Ullrich").
27. Regarding claim 21, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
The combination of Batchelor, Paul, and Miller ‘771 does not, however, teach:
producing a sensory output signal, with the computer, in response to the output control signal.
Ullrich, in a similar field of endeavor, teaches a laparoscopic surgical tool for sealing and transecting tissue, and a tactile feedback system integrated onto a handle of the tool that generates relevant feedback in at least the form of haptic effects to the user [e.g., ¶[0018]; note also that Ullrich teaches use in other procedures including vascular or other catheterization (¶[0051])]. Ullrich teaches the use of tool sensors, including impedance sensors [¶[0025]], as well as the use of mapping logic configured to map sensed/calculated values derived from the tool sensor(s) onto tactile feedback signals or commands [¶[0026]]. Further, Ullrich teaches that haptic feedback may be provided regarding a variety of different parameters or factors including, e.g., guidance as to the readiness of tissue for treatment [e.g., ¶[0038]], as well as to indicate the presence or absence of energy application [e.g., ¶’s [0018], [0045], [0046]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor, Paul, and Miller ‘771 to include producing a sensory output signal, with the computer, in response to the output control signal, since such a modification would provide the benefit/advantage of facilitating a procedure for a surgeon by providing reliable, tactile information to communicate information reliably independent of the surgeon’s sight or hearing (i.e., without requiring the surgeon to continually look at a display), which can help minimize distraction.
28. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Batchelor, Paul, and Miller ‘771, as applied to claim 13 above, and further in view of Nguyen and U.S. Patent Application Publication No. 2018/0147007 to Purdy et al. ("Purdy”).
29. Regarding claim 22, the combination of Batchelor, Paul, and Miller ‘771 teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Thermocouple
The combination of Batchelor, Paul, and Miller ‘771 does not, however, teach:
monitoring a measured temperature of the target anatomical feature with a thermocouple on the ablation probe, the thermocouple in electrical communication with the computer.
Nguyen, in a similar field of endeavor, teaches that it was known to place a temperature sensor (162) (e.g., a thermocouple) on a probe (110) adjacent to an energy delivery coil (120) for monitoring temperature during a procedure [see ¶[0108] (“A temperature sensor 162 (e.g., a thermocouple (such as a K-type bifilar thermocouple), thermistor, or the like) is preferably positioned within or adjacent to the coil 120. In the depicted embodiment, the temperature sensor 162 is located about midway along the length of the coil, in a gap formed between adjacent winds of the coil. A pair of leads (not shown in FIG. 3 or 4) are connected to the temperature sensor 162 to provide temperature information to the power supply 210”)]
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor, Paul, and Miller ‘771 to include monitoring a measured temperature of the target anatomical feature with a thermocouple on the ablation probe, the thermocouple in electrical communication with the computer, since such feedback/monitoring would allow for the prevention of unintended thermal damage to, e.g., surrounding, non-target tissue, thereby increasing the overall safety of a procedure.
Terminating Ablation
The combination of Batchelor, Paul, Miller ‘771, & Nguyen does not, however, explicitly teach:
stopping an ablation of the target anatomical feature when the measured temperature is higher than a predetermined ablation threshold temperature for a predetermined time period.
Purdy, in a similar field of endeavor, teaches that it was known to terminate the application of ablative energy once a predetermined temperature has been reached in order to restrict ablation to a desired region, and prevent the unintended heating of healthy tissue [see ¶[0070] (“Once the tissue has reached a sufficient temperature (e.g., approximately 50° C., such as between 45° C. and 55° C.) as measured by one or more temperature sensors, such as the temperature sensors 158, 159 on the stylet 181 of the thermal energy delivery probe 180, the medical device 100 may be deactivated, thereby preventing the unintended heating of healthy tissue. Stated differently, one or more thermocouples may be used to actively monitor temperature within the desired ablation region. When radiofrequency energy from the thermal energy delivery device 180 causes the tissue to reach a predetermined (e.g., ablation) temperature, the medical device 100 may be deactivated, thereby restricting ablation to the desired region”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Batchelor, Paul, Miller ‘771, and Nguyen to include stopping an ablation of the target anatomical feature when the measured temperature is higher than a predetermined ablation threshold temperature for a predetermined time period, in order to provide the benefit/advantage of restricting ablation to a desired region and preventing unintended thermal damage to, e.g., surrounding, non-target tissue, thereby increasing the overall safety of a procedure.
Response to Arguments
30. The rejections under § 103 previously set forth in the 12/18/25 Action have been updated responsive to Applicant’s amendment, and maintained.
31. In the 03/17/26 Amendment, independent claims 1 & 13 were amended to include the limitations of dependent claims 2 & 15 (now cancelled), respectively, concerning the interlock switch. Independent claim 12 was amended to include a similar limitation.
32. As noted above in the body of the rejections of independent claims 1, 12, & 13, Batchelor teaches the limitation of producing an output control signal when the electrical characteristic [impedance] measured by the first and second electrical sensors indicates that the electrode is aligned with a target anatomical feature [e.g., ¶’s [0222], [0233], & [0236]].
33. Miller ‘771 was then relied upon (in the prior rejections of dependent claims 2 & 15) for the teaching of the claimed interlock switch configured to transition from the default open state (in which the electrode is electrically disconnected from the power source) to the closed state (in which the electrode is electrically connected to the power source) in response to the output control signal.
34. In the Remarks, Applicant’s sole argument against the propriety of the rejection under § 103 based on the combination of Batchelor, Paul, & Miller ‘771, now relied upon for the rejections of independent claims 1, 12, & 13, is because “Miller ‘771 discloses using impedance measurements for process control during ablation” [03/17/26 Amendment, pg. 10]. In support of this contention, Applicant cites the embodiment referenced in ¶[0056] and FIG. 11 of Miller ‘771 which does show the use of impedance measurements to control energy delivery during ablation. It is the Examiner’s position, however, that the relied-upon teachings of Miller ‘771 [at ¶’s [0058]-[0059]] clearly teach the use of impedance measurements in a prospective manner, i.e., to determine/plan where ablation will be programmed to occur:
[0058] An additional feature of the invention is using the information obtained with the imaging and/or impedance measurements to control the ablative process. The invention thus allows the position and the strength of the ablation to be programmed and executed. Using the disclosed system, it is also possible to display and program treatment using the graphical user interface described above.
[0059] For example, in an embodiment, after evaluating a vessel, a physician would like to direct ablation limited to a segment of the interior of a vessel. It is based upon the value of the electrical impedance along a small area of the surface of the lumen. With the control system described above it is possible to automatically switch the ablative member on and off based upon the impedance measurement…
Miller ‘771, ¶’s [0058]-[0059], emphasis added.
Determining where a user “would like to” direct ablation, and the ability to “program treatment” based on measured impedances demonstrates that impedance measurements are not just limited to use during ablation, as Applicant argues. Moreover, the Examiner’s interpretation is consistent with, and further supported by, other passages of Miller such as, e.g.:
[0006] The invention is a system for safely ablating tissue. In an embodiment, the system comprises an ablation catheter having an ablation member and being capable of IVUS imaging. The system additionally includes an impedance sensor and a controller that takes measurements from the impedance sensor and determines whether the impedance value is in excess of a safe value and, thus, whether it is safe to continue ablating the tissue. In other embodiments, the system images the tissue before and during ablation and uses the images to determine the safe application of ablation energy. In other embodiments, the system evaluates the tissue prior to ablation with the impedance sensor and combines the impedance measurements with the images to direct a course of ablation treatment. In other embodiments, the system can be programmed to automatically perform the ablation based upon imaging and/or impedance data obtained prior to beginning the procedure. In some embodiments, the system additionally uses feedback from the impedance sensor to evaluate the progress of a programmed ablation.
Miller ‘771, ¶[0006], emphasis added.
Thus, the modification of Batchelor and Paul to utilize a known, art-recognized switch for automatically transitioning from a default open state to a closed state (in which the electrode is electrically connected to the power source), such as that of Miller ‘771, in response to an output control signal produced when the electrical characteristic [impedance] measured by the first and second electrical sensors indicates that the electrode is at a desired treatment position would have been obvious for the reasons set forth herein in the body of the rejections. Applicant has failed to establish otherwise. For these reasons, the rejection of independent claims 1, 12, & 13 under § 103 based on the combination of Batchelor, Paul, & Miller ‘771 is maintained.
Conclusion
35. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
36. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
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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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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