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 Objections
Claim 1 is objected to because of the following informalities: line 2 of claim 1 should recite “providing a PFA system” (no capitalization on the “p”). Appropriate correction is required.
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.
Claims 14-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 is unclear with the scope of the claim, particularly in that the second line recites “the system is connectable to”. The language “connectable to” implies the structure after the phase (i.e. the ablation catheter having at least one ablation electrode and a plurality of patches) is intended use and not directed to positive claim limitations. However, the claim continues to positively recite the limitations of the ablation catheter in the remainder of the claim making it unclear if the ablation catheter is a positive inclusion in the claimed invention. Claims 15-23 are rejected based on their dependency from claim 14.
Claim 24 is unclear with the phrase “a return electrode being skin surface electrode” and appears it should read “being a skin surface electrode”. Also, the claim lacks proper antecedent basis for “to PFA energy generator” and should apparently read “to a PFA energy generator”.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 8-15 and 18-26 are rejected under 35 U.S.C. 103 as being unpatentable over Canady, Jr. et al (2021/0228260) in view of the teaching of Lee, Jr. et al (7,736,357).
Canady, Jr. et al provide a method of unipolar pulsed field ablation (para. [0068], for example) comprising at least one catheter (104) having at least one electrode (102) serving as a first pole provided at the distal end of the catheter (Figure 2). Canady, Jr. et al also disclose the device may be used in the monopolar mode using multiple ground pad electrodes (para. [0087]). Motion sensors are coupled to the body to monitor tissue motion/spasms (para. [0038]), which sensors are used to detect movement during the delivery of PFA pulses and to control operation of the device based on the sensed movement. Control may include electrode polarization and the control of pulse parameters (para. [0056], for example), and may also remove voltage from an electrode interface (para. [0048]). While Canady, Jr. et al disclose controlling parameters in response to motion sensors, there is no express disclosure of selecting certain return patches for continued deliver of PFA pulses in response to motion sensing.
Lee, Jr. et al provides another device comprising a catheter (16) having an ablation electrode at the distal end and a plurality of patch electrodes (50) serving as the ground pole for the delivery of pulsed energy to tissue. In particular, Lee, Jr. et al teach that it is known to sense parameters at the patch electrodes (in this case, temperature and/or impedance) and to control the delivery of energy to specific ground electrodes based on the sensed parameters. Certain ground patches (50) may be selected to continue to serve as a ground pole, or may be disable such that delivery only continues to other ground patches. See, for example, column 2, lines 17-50.
In as much as Canady, Jr. et al provide multiple ground patches to serve as a return for a monopolar ablation system and provides motion sensors to control the delivery of energy based on sensed motion, it would have been obvious to one of ordinary skill in the art at the time of the invention to have provided the ground patches with motion sensors to determine which ground pads would be used to return energy based on sensed motion since Lee, Jr. et al fairly teach it is known to use sensors on ground pads to determine which ground pads are activated to return energy based on sensed parameters.
Regarding claims 2-4, the Canady, Jr. et al motion sensor detects position changes and is an IMU (i.e. accelerometer). See paragraph [0048]. Regarding claim 8, Lee, Jr. discloses the step of identifying a sensed parameter and, responsive to the parameter, selecting one or more patch electrodes to act as ground. To have used such steps in the Canady, Jr. device by providing the motion sensor on the patch (i.e. return) electrodes would have been obvious to a skilled artisan given the teaching of Lee, JR. Regarding claim 9, Lee, Jr. teaches the selection of return electrodes is done automatically based on sensed parameters (columns 2 and 3, for example). Regarding claim 10, Canady, Jr. discloses providing motion sensors and Lee, Jr. provide the motivation to provide such sensors on ground pad (i.e. patch) electrodes to control operation of the patch electrodes. Regarding claim 11, see discussion of Lee, Jr. who disclose independent control of multiple ground pad electrodes. Regarding claim 12, see again Lee, Jr. who disclose controlling energy to individual patch electrodes based on sensed parameters. Regarding claim 13, Lee, Jr. discloses electrode patches with a coupling member to secure a sensing device (Figures 4 and 7, for example).
Regarding claim 14, Canady, JR. et al provide a system for unipolar PFA (as addressed previously) comprising a catheter having at least one ablation electrode and a plurality of electrode patches comprising a return electrode. Canady, Jr. also disclose a motion sensor whereby an energy generator is adapted to deliver PFA pulses. Canady, Jr. fails to expressly disclose a signal switch connected to the PFA generator and the plurality of patch electrodes as claimed. However, Lee, Jr., as addressed previously, disclose a switching mechanism to selectively connect individual patch electrodes from a multiple set of patch electrodes to the PFA generator based on sensed conditions at each patch electrode. See, for example, Figure 7 which shows the switching arrangement, and column 4 which discusses the processor adapted to monitor the parameters (e.g. temperature and/or impedance) at each patch electrode to individually control the delivery of energy to each patch electrode. To have provided the Canady, Jr. system with multiple patch electrodes, each having a motion sensor, and a processor to control the delivery of energy to the individual patch electrodes based on the motion sensor readings would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Lee, Jr. fairly teaches the individual control of energy delivery to multiple patch electrodes based on parameters sensed at the individual patch electrodes.
Regarding claim 15, the motion sensor of Canady, Jr. comprises a position sensor or IMU (i.e. accelerometer as per paragraph [0038]). Regarding claim 18, both Canady, JR. and Lee, Jr provide a user interface to alert the user to conditions and to allow for adjustments to the system. Regarding claim 19, see discussion of claim 9 above. Regarding claim 20, see discussion of claim 10 above. Regarding claim 21, see discussion of claim 11. Regarding claim 22, see discussion of claim 12. Regarding claim 23, Lee, Jr. discloses the use of multiple sensors, including temperature sensors and impedance sensors.
Regarding claim 24, Canady, Jr. discloses a PFA patch electrode as discussed previously, and also teach of providing motion sensors to control the delivery of energy to tissue. Canady, Jr. fails to expressly disclose providing the motion sensor on the patch electrode. Lee, Jr., as addressed previously, teach that it is known to provide sensors on multiple patch electrodes to control the use of individual patch electrodes during an RF treatment. To have provided the Canady, Jr. device with the motion sensors on the patch electrodes to allow for the individual control of energy delivery to tissue and to the individual patch electrodes would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Lee, Jr. fairly teach it is known to provide sensors on the patch electrodes to control energy delivery.
Regarding claim 25, Lee, Jr. teaches the sensors are integrally coupled with the patch electrodes. Regarding claim 26, the patch electrodes of Lee, Jr. are integrally coupled with the sensors, and the patch electrodes are disposable.
Claims 5-7, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Canady, Jr. et al (2021/0228260) in view of the teaching of Lee, Jr. et al (7,736,357) and further in view of the teaching of Howard (2019/0038171).
Canady, Jr. in view of Lee, Jr. fail to disclose wireless motion sensors, or the specific frequency filtering or spectral analysis for the sensed motion signals.
Howard discloses another PFA device that uses motion sensors (i.e. accelerometers) to determine spasms that result from the application of pulses to tissue. See, for example, paragraph [0052]. The same paragraph teaches the motion sensors may be wireless, and also discusses frequency analysis of the signals for determining spasms.
To have provided the Canady, Jr. device, as modified by the teaching of Lee, Jr., with a wireless motion sensor would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Howard fairly teaches it is known to use wireless motion sensors in a similar PFA device. To have further provided spectral analysis of the spasm frequency to better identify muscle spasms by the motion sensors would have been an obvious consideration for the skilled artisan since Howard fairly teaches such a step is known.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Govari et al (2025/0248757) discloses another PFA system that utilizes motion sensors. Miller et al (8,403,925), Gregg (8,100,898) and Pontis (2009/0171344) discloses other devices having return patches with sensors on the return patches.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/November 19, 2025