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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it exceeds 150 words and contains legal phraseology. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 5 and 7 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 5 recites the limitation "the pulse width" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "perform voltage and current sampling" in line 7. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this voltage and current sampling is different from the voltage and current sampling already performed earlier in the claim, or if they are the same voltage and current sampling occurring both after a delay and in a time smaller than the pulse width. For examination purposes, Examiner will treat both voltage and current samplings as occurring in the same time period after the delay and in the time smaller than the pulse width.
Claim 5 recites the limitation "transmit a sampling signal" in lines 7-8. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this sampling signal is different from the voltage and current sampling already performed earlier in the claim, or if they are the same sampling signal. For examination purposes, Examiner will treat both voltage and current samplings and the sampling signal as the same.
Claim 7 recites the limitation "the voltage amplitude" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue (C.N. Application No. 112022331 B).
Regarding independent claim 1, Xue discloses a closed-loop control system for pulse ablation, comprising an electric pulse host (1000) and an electrode group (2400, 2500) (page 5, lines 5-8 under “Detailed Description” & Fig. 1), the electrode group comprising a plurality of electrodes (i.e., group of electrodes comprising a detection electrode and an ablation electrode) (page 6, lines 24-27);
the electric pulse host comprising a main control module (i.e., combination of a central control unit of a lower computer 1900’ and a control unit of an upper computer 1900) (page 3, lines 6-8, bottom-up; page 5 last paragraph – page 6 lines 1-8 and lines 13-14), a pulse transmission module (asymmetric pulse discharge circuit) (page 2, lines 2-5; page 6, lines 15-23), an electrophysiological signal sampling module (upper computer 1900), a first electrode control unit and a second electrode control unit (discharge switch elements comprising a bridge circuit made up of relays or switch tubes and four control drive units) (page 3, lines 17-21, bottom-up);
the main control module being sequentially connected with the pulse transmission module, the first electrode control unit and the electrode group (see Figs. 1-2), the main control module controlling the pulse transmission module to output a pulse signal and selecting a specific electrode through the first electrode control unit to release the pulse signal (page 3, lines 14-16, bottom-up and lines 4-5, bottom-up);
the main control module being sequentially connected with the electrophysiological signal sampling module, the second electrode control unit and the electrode group (see Figs. 1-2), the main control module selecting an electrode through the second electrode control unit and sampling an electrocardiogram signal through the electrophysiological signal sampling module (page 3, lines 6-8, bottom-up), the electrocardiogram signal referring to a potential amplitude signal (R wave) between the selected electrodes (page 6, lines 34-38); the main control module determining a treatment progress (page 3, paragraph under “Disclosure of Invention”) according to the sampled electrocardiogram signal and adjusting the pulse signal output by the pulse transmission module in real time according to the treatment progress (page 6, lines 24-27 and lines 31-33).
Regarding claim 2, Xue discloses wherein the pulse transmission module and the electrophysiological signal sampling module work alternately and switch once every heartbeat cycle (page 3, last paragraph – page 4, lines 1-6).
It is noted that the recitation of “the pulse transmission module and the electrophysiological signal sampling module work alternately and switch once every heartbeat cycle” is regarded as a functional recitation of the intended use of the closed-loop control system. It has been held that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the pulse transmission module of Xue readily provides for such functionality given that the system allows the user to readably adjust the discharge pulse signals to be outputted in specific cycles.
Regarding claim 3, Xue discloses wherein the main control module achieves single-electrode pulse transmission control and single-electrode electrocardiograph signal sampling through the first electrode control unit and the second electrode control unit (page 4, lines 10-12).
Regarding claim 6, Xue discloses wherein the main control module controls the pulse transmission module to release the pulse signal in an electrocardiogram refractory period according to the electrocardiogram signal (page 6, lines 34-38).
Regarding claim 7, Xue discloses wherein the closed-loop control system for pulse ablation further comprises a man-machine interaction module (combination of the upper computer 1900 console, a display device, a foot switch, and input/output panel; page 6 line 9), the man-machine interaction module is connected with the main control module and configured to set parameters, and the parameters comprise the voltage amplitude and pulse width of the pulse signal (page 6 lines 4-8 and lines 15-23).
Regarding claim 8, Xue discloses wherein the pulse transmission module comprises a high-voltage power supply (1200) and a pulse generation circuit, and the pulse generation circuit achieves a bidirectional pulse by adopting a four-way switch module (page 3, lines 17-21, bottom-up; page 5, line 9 and lines 23-25 under “Detailed Description”).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xue as applied to claim 1 above, and further in view of Gorzycki (U.S. Application No. 20210322086 A1).
Regarding claim 4, Xue discloses the main control module determining a treatment progress according to the sampled electrocardiogram signal and adjusting the pulse signal output by the pulse transmission module in real time according to the treatment progress (page 6, lines 24-27 and lines 31-33).
However, Xue does not disclose the detailed steps described in the rest of the claim.
Gorzycki, in the same field of endeavor, teaches an ablation system comprising an ECG detector (30) comprising a set of ECG electrodes (pa. 0055 & Fig. 1), the system includes a controller (100) comprising a microcontroller or microprocessor adapted to execute programmable instructions (pa. 0056 & Fig. 2) and a triggering circuit (160) configured to receive, process, and analyze an ECG-type signal (pa. 0058).
During a treatment regiment, a cardiac beat or cycle of the patient is analyzed in order to set a safe period used for delivery of therapy, the safe period being between the R-wave and the T-wave, wherein the analysis includes identifying/detecting features of the cardiac signal such as, for example, the QT interval at a given cardiac rate, measuring and recording QRS width, amplitude of any of the P, R, or T waves, shape of the P-wave or QRS complex, shape/elevation of the signal during the ST interval relative to a baseline, etc. (pa. 0074, 0080). In order to detect the features of the beat, a detection threshold is applied to the cardiac signal to detect the cardiac event (pa. 0081), wherein several methods may be employed to confirm beat detection using slew rate, width, and/or amplitude (pa. 0082-0084) (i.e., when performing first electrocardiograph signal sampling, if a sampled electrocardiograph signal A is greater than a first threshold, the main control module controlling the pulse transmission module to output a pulse signal according to a set voltage amplitude and pulse width).
A second beat may then be sensed/detected, with confirmation of the beat taking place before the therapy is issued using the safe period settings previously defined by the first/previous beat. After therapy is issued, the process repeats for the future beats with an updated safe period set using those respective future beats (pa. 0080 Fig. 6) (i.e., for each subsequent electrocardiograph signal sampling, comparing a newly sampled electrocardiograph signal with a previously sampled electrocardiograph signal). Using the slew rate to confirm a beat, some patients have wide QRS complexes, and the use of width may be tailored to such patients by measuring R-wave or QRS width in advance to set a threshold use in a width analysis. It may be noted that the P-wave and R-wave may not be distinguished readily using width, and this issue can be addressed, for example, by configuring/adjusting the location of the surface QRS sensing electrodes in relatively lower positions relative to the heart (pa. 0083) (i.e., if the newly sampled electrocardiogram signal presents no change, indicating that the position of the corresponding electrode needs to be adjusted).
Depending on the safe window/period duration, the burst to be delivered as ablation therapy can be adjusted. For example, a therapy burst can be issued as a series of square wave pulses each having a pulse width, separated by an interpulse interval, up to a set quantity of the pulses, and the duration of the pulses can be adjusted to fit within the safe period (pa. 0075) (i.e., if the newly sampled electrocardiogram signal presents a change, calculating a change amplitude and correspondingly adjusting waveform parameters of the pulse signal output by the pulse transmission module according to the change amplitude).
Lastly, the detected events in the ECG signal may be passed through a confirmation routine, wherein if the detected event passes the confirmation routine, the beat is confirmed and therapy is delivered and the treatment ends, but if the detected event fails the confirmation routine, the ECG signal detection process continues (pa. 0094-0096) (i.e., when the newly sampled electrocardiogram signal reaches a set second threshold, ending an ablation process).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the ECG detector, the controller, and the triggering circuit of Gorzycki to the system taught by Xue for the purpose of allowing the main control module to determine the treatment progress according to the sampled electrocardiogram signal by more accurately and efficiently analyzing the ECG signals.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Xue as applied to claim 1 above, and further in view of Sano (W.O. Application No. 2020243461 A1).
Regarding claim 5, Xue discloses wherein the closed-loop control system for pulse ablation further comprises a voltage (1600) and current sensor (1700) (page 5, lines 9-10, under “Detailed Description”).
However, Xue does not disclose the voltage and current sensors are configured to monitor arc discharge caused by a position change between the electrodes, after the pulse signal is triggered, perform voltage and current sampling after a delay of certain time, nor perform voltage and current sampling in time smaller than the pulse width, transmit a sampling signal in real time to the main control module for analysis after analog-to-digital conversion, and perform arc determination by determining change characteristics of voltage and current.
Sano, in the same field of endeavor, teaches an ablation system comprising an apparatus for preventing, mitigating, and/or reducing tissue damage during a pulsed electric field therapy comprising a plurality of electrical pulses. The system further comprises circuitry configured to detect an onset and/or occurrence of an electrical arc and dynamically modify a delivery profile of the electrical pulses responsive to the detection (pa. 0018). As seen in figures 2A-2C, graphs of current (112) measurements and voltage (111) measurements are used to determine electric arcing during pulsed electric field therapies, wherein the arcing events can be detected in real time by hardware and/or software and may be used to halt pulse delivery and/or modify the pulse delivery protocol to prevent and/or reduce the occurrence of electrical arcing during subsequent pulses (pa. 00108).
Figures 3A-3C illustrate a method of preventing electrical arcing by dynamically modifying the pulse delivery profile. Referring to figure 3A, a pulse (Pulse n) of a plurality of electrical pulses of the pulsed electric field therapy may be identified as not having an electrical arc detected. Referring to figure 3B, a pulse (Pulse n+1) of the plurality of electrical pulses may be identified as having a component with a rapidly increasing current, and thus a potential future electrical arc may be identified. Referring to figure 3C, the delivery rate of an electrical pulse (Pulse n+2) may be modified responsive to detecting the potential electrical arc. When the potential electrical arc is identified, the time within the pulse at which that event occurred may be recorded. In some embodiments, the modification may include an alteration of a duration of the electrical pulse (e.g., a shortened duration) and/or an alteration of an amplitude of the electrical pulse (pa. 00109). In other words, after the pulse signal is triggered (starting in Pulse n), the ablation system is able to continuously sample the voltage and current after a delay of certain time, wherein the delay is defined as the time between the end of Pulse n and the end of Pulse n+1. Examiner notes that the claim language is broad and does not require the voltage and current sampling be conducted between pulses or not during a pulse. Furthermore, the voltage and the current sampling is conducted in a time smaller than the pulse width given that, as seen in figure 2C, the ablation system is able to detect and record a specific point in time where an arcing event has occurred, wherein that specific point in time is smaller than the total pulse width. After the sampling of the voltage and current signal is conducted, the ablation system transmits the signal to the circuitry for analysis after analog-to-digital conversion, and the system further modifies the pulse signal in real time (pa. 00121).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the arc detection circuitry and other hardware/software taught by Sano into the control system of Xue for the purpose of allowing the user to monitor, mitigating, and preventing future arcing events that may be harmful to the patient.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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