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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/02/2024 and 11/25/2025 are being considered by the examiner.
Claim Objections
Claims 16 and 18 are objected to because of the following informalities:
Claims 16 line 2 recites “ablation region is a PH level of the ablation region” should read -- ablation region is a pH level of the ablation region --.
Claim 18, line 7, recites “a PH level of the ablation region; and” should read -- a pH level of the ablation region; and --.
Appropriate correction is required.
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.
Claim(s) 1, 2, 4 and 17 is/are rejected under 35 U.S.C. 102(a)(1)(/102(a)(2) as being anticipated by Fang et al. (CN 112932648) herein referred to as “Fang”.
Regarding claim 1, Fang discloses an ablation system (preheating pulse ablation system, Abstract, see attached), comprising:
a radio frequency generation module configured to generate radio frequency output (current source 2 is a radio frequency current source, Figure 1, Page 4, Paragraph 4, see attached);
a pulse generation module configured to generate pulse output (module 3 is a high voltage pulse current source, Figure 1, Page 4, Paragraph 4, see attached);
an output control module configured to choose, according to a characteristic of an ablation region, between ablation output modes of the radio frequency output and the pulse output (the electric control unit 8 is connected with the current source 1, the on-off and mutual switching of the radio frequency current source module 2 and the high-voltage pulse current source module 3 are controlled, control signals are respectively input by the heart rate monitor 4 and the temperature control unit 9, Page 4, Paragraph 14); and an ablation consumable configured to perform output for the ablation region according to the ablation output mode chosen by the output control module (the controlled and output current is output through the electrode conduit 14 (seen as the ablation consumable), Page 4, Paragraph 14).
Regarding claim 2, Fang discloses the ablation system according to claim 1, wherein the output control module is configured to select one of the following ablation output modes: radio frequency only output; pulse only output; and pulse and radio frequency hybrid output (the electric control unit 8 is connected with the current source 1, the on-off and mutual switching (seen as selecting either radio frequency only or pulse only output) of the radio frequency current source module 2 and the high-voltage pulse current source module 3 are controlled, control signals are respectively input by the heart rate monitor 4 and the temperature control unit 9, Page 4, Paragraph 14).
Regarding claim 4, Fang discloses the ablation system according to claim 1, wherein the output control module is configured to automatically choose the ablation output mode (the electric control unit 8 is connected with the current source 1, the on-off and mutual switching (seen as automatic) of the radio frequency current source module 2 and the high-voltage pulse current source module 3 are controlled, control signals are respectively input by the heart rate monitor 4 and the temperature control unit 9, Page 4, Paragraph 14).
Regarding claim 17, Fang discloses the ablation system according to claim 1.
Fang further discloses wherein the characteristic of the ablation region is a change in a parameter of the ablation region before and after pre-test ablation (the temperature sensor in the electrode catheter measures the contact temperature of the electrode catheter and the target position; judging whether the target and temperature reach the required set temperature Tset, Page 5, Paragraphs 5, see attached).
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Mehta et al. (US 9119628 B1) herein referred to as “Mehta”.
Regarding claim 3, Fang discloses the ablation system according to claim 1.
Fang discloses wherein the output control module is configured that the ablation output mode of the output control module is automatically chosen (Page 4, Paragraph 25). However Fang does not explicitly disclose wherein the output control module is configured that the ablation output mode of the output control module is manually chosen by an operator.
Mehta discloses a multiple electrode probe for ablation procedures (Col. 26, lines 39-41), wherein the output control module is configured that the ablation output mode of the output control module is automatically chosen by an operator (each of the electrodes 2046-2065 may be preferably be selectively connected to a stimulation current source, an ablation energy source, a ground or left unconnected, the electrodes 2046-2062 may be connected manually, Col. 26, lines 34-38).
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 modified Fang to incorporate
the teachings of Mehta by including wherein the output control module is configured that the ablation output mode of the output control module is automatically chosen by an operator. The motivation to do so being to manually connect the electrodes to the desired output source (Mehta, Col. 26, lines 34-38).
Claims 5-10 and 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Cosman et al. (US 20150320478 A1) herein referred to as “Cosman”.
Regarding claim 5, Fang discloses the ablation system according to claim 1.
However Fang does not explicitly disclose wherein the characteristic of the ablation region is a pre-estimated characteristic of the ablation region.
Cosman discloses a high-frequency ablation system (Abstract) wherein the characteristic of the ablation region is a pre-estimated characteristic of the ablation region (the controller 840 can adjust the ablation process using an estimate of lesion size, Paragraph [0200]).
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 modified Fang to incorporate
the teachings of Cosman by including wherein the characteristic of the ablation region is a pre-estimated characteristic of the ablation region. The motivation to do so being to adjust the ablation process using estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Regarding claim 6, Fang discloses the ablation system according to claim 1.
However Fang does not explicitly disclose wherein the characteristic of the ablation region is a size of the ablation region.
Cosman discloses wherein the characteristic of the ablation region is a size of the ablation region (the controller 840 can adjust the ablation process using an estimate of lesion size, Paragraph [0200]).
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 modified Fang to incorporate
the teachings of Cosman by including wherein the characteristic of the ablation region is a size of the ablation region. The motivation to do so being to adjust the ablation process using estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Regarding claim 7, Fang in view of Cosman discloses the ablation system according to claim 6.
However Fang does not explicitly disclose wherein the size of the ablation region is determined by a parameter of the pulse ablation.
Cosman discloses wherein the size of the ablation region is determined by a parameter of the pulse ablation (the controller 840 can adjust the ablation process using an estimate of lesion size, Paragraph [0200], wherein the estimate of the lesion size is based on the parameters set for the ablation process, Paragraph [0165], pulse ablation, Paragraph [0174] and [0198]).
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 modified Fang to incorporate
the teachings of Cosman by including wherein the size of the ablation region is determined by a parameter of the pulse ablation. The motivation to do so being to adjust the ablation process using estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Regarding claim 8, Fang in view of Cosman discloses the ablation system according to claim 7.
However Fang does not explicitly disclose wherein the parameter of the pulse ablation comprises at least one of: a pulse amplitude, a pulse width, a number of pulse groups, and a number of pulses.
Cosman discloses wherein the parameter of the pulse ablation comprises at least one of: a pulse amplitude, a pulse width, a number of pulse groups, and a number of pulses (the controller 840 can enable and disable the Stim source, adjust the timing of stimulation pulses, adjust the frequency of stimulation pulses, adjust the pulse width of stimulation pulses, adjust the amplitude of the stimulation pulses (seen as adjusting the parameters preset to predict the lesion size), Paragraph [0200]).
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 modified Fang to incorporate
the teachings of Cosman by including wherein the parameter of the pulse ablation comprises at least one of: a pulse amplitude, a pulse width, a number of pulse groups, and a number of pulses. The motivation to do so being to adjust the specific ablation process parameters using estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Regarding claim 9, Fang in view of Cosman discloses the ablation system according to claim 6.
However Fang does not explicitly disclose wherein the size of the ablation region is determined by a parameter of the radio frequency ablation.
Cosman discloses wherein the size of the ablation region is determined by a parameter of the radio frequency ablation (the controller 840 can enable and disable the output of the RF source, adjust the amplitude of the RF signal (seen as adjusting the specific parameters of the RF source based on an estimated lesion size determined from the preset parameters of the RF source), and measure the RF voltage, current, and power, Paragraph [0200]).
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 modified Fang to incorporate
the teachings of Cosman by including wherein the size of the ablation region is determined by a parameter of the radio frequency ablation. The motivation to do so being to adjust the specific ablation process parameters using estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Regarding claim 10, Fang in view of Cosman discloses the ablation system according to claim 9.
However Fang does not explicitly disclose wherein the parameter of the radio frequency ablation comprises at least one of: a power, a temperature, a time, and a perfusion volume.
Cosman discloses wherein the parameter of the radio frequency ablation comprises at least one of: a power, a temperature, a time, and a perfusion volume (the controller 840 can enable and disable the output of the RF source (seen as power), adjust the amplitude of the RF signal (seen as adjusting the specific parameters of the RF source based on an estimated lesion size determined from the preset parameters of the RF source), and measure the RF voltage, current, and power, Paragraph [0200]).
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 modified Fang to incorporate
the teachings of Cosman by including wherein the parameter of the radio frequency ablation comprises at least one of: a power, a temperature, a time, and a perfusion volume. The motivation to do so being to adjust the specific ablation process parameters using estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Regarding claim 18, Fang discloses the ablation system according to claim 1, wherein the output control module is further configured to choose the ablation output mode according to at least a change in the parameter of the ablation region before and after pre-test ablation (the temperature sensor in the electrode catheter measures the contact temperature of the electrode catheter and the target position; judging whether the target temperature reach the required set temperature Tset, Page 5, Paragraphs 7 and 10, see attached).
However Fang does not explicitly disclose wherein the output control module is further configured to choose the ablation output mode according to at least two of the following characteristics of the ablation region: a size of the ablation region; a position of the ablation region; an electrical impedance of the ablation region; a PH level of the ablation region; and a change in the parameter of the ablation region before and after pre-test ablation.
Cosman discloses wherein the output control module is further configured to choose the ablation output mode according to a size of the ablation region (the controller 840 can adjust the ablation process using an estimate of lesion size, Paragraph [0200]).
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 modified Fang to further incorporate the teachings of Cosman by including the output control module is further configured to choose the ablation output mode according to a size of the ablation region. The motivation to do so being to adjust the ablation process using the size estimates from the ultrasound machine (Cosman, Paragraph [0200]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Altmann et al. (US 11540877 B2) herein referred to as “Altmann”.
Regarding claim 11, Fang discloses the ablation system according to claim 1.
However Fang does not explicitly disclose wherein the characteristic of the ablation region is a position of the ablation region.
Altmann discloses a pulse generator for irreversible electroporation (Abstract) wherein the characteristic of the ablation region is a position of the ablation region (one or more electromagnetic position sensors (not shown) in the distal end 28 of device 26, Figure 1, Col. 7, lines 1-8).
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 modified Fang to incorporate
the teachings of Altmann by including wherein the characteristic of the ablation region is a position of the ablation region. The motivation to do so being to ascertain the positions of the electrodes within the human body to be within a target region (Altmann, Col. 7, lines 6-8).
Regarding claim 12, Fang discloses the ablation system according to claim 11.
However Fang does not explicitly disclose wherein the ablation consumable has a corresponding position sensor, and the ablation system further comprises: a position signal acquisition module configured to acquire position information of the ablation consumable according to the position sensor of the ablation consumable; and a navigation system configured to determine the position of the ablation region according to the position information of the ablation consumable acquired by the position signal acquisition module.
Altmann discloses wherein the ablation consumable has a corresponding position sensor (one or more electromagnetic position sensors (not shown) in the distal end 28 of device 26, Figure 1, Col. 7, lines 1-8), and the ablation system further comprises: a position signal acquisition module configured to acquire position information of the ablation consumable according to the position sensor of the ablation consumable (a tracking module is coupled to the one or more electromagnetic position sensors in the distal end 28, in the presence of an external magnetic field generated by one or more magnetic field-generators 62, the electromagnetic position sensors output signals that vary with the positions of the sensors, Col. 7, lines 1-6); and a navigation system configured to determine the position of the ablation region according to the position information of the ablation consumable acquired by the position signal acquisition module (based on these signals, tracking module 60 may ascertain the positions of the electrodes 30 in the heart 52, Col. 7, lines 6-8).
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 modified Fang to incorporate
the teachings of Altmann by including wherein the ablation consumable has a corresponding position sensor, and the ablation system further comprises: a position signal acquisition module configured to acquire position information of the ablation consumable according to the position sensor of the ablation consumable; and a navigation system configured to determine the position of the ablation region according to the position information of the ablation consumable acquired by the position signal acquisition module. The motivation to do so being to ascertain the positions of the electrodes within the human body (Altmann, Col. 7, lines 6-8).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Davalos et al. (WO 2020061192) herein referred to as “Davalos”.
Regarding claim 13, Fang discloses the ablation system according to claim 1.
However Fang does not explicitly disclose wherein the characteristic of the ablation region is an electrical impedance of the ablation region.
Davalos discloses methods and techniques for treating a tissue using non-thermal ablation (Abstract) wherein the characteristic of the ablation region is an electrical impedance of the ablation region (tumor tissue impedance can include measuring impedance using an impedance sensor during the initial non-thermal ablation treatment, Page 29, lines 9-30).
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 modified Fang to incorporate
the teachings of Davalos by including wherein the characteristic of the ablation region is an electrical impedance of the ablation region. The motivation to do so being to measure bulk conductivity of the tissue to further perform an additional downstream treatment in response to the change in bulk tissue conductivity (Davalos, Page 30, lines 9-17).
Regarding claim 14, Fang in view of Davalos discloses the ablation system according to claim 13.
However Fang does not explicitly disclose wherein the ablation system further comprises an impedance detection module configured to detect the electrical impedance of the ablation region.
Davalos discloses wherein the ablation system further comprises an impedance detection module configured to detect the electrical impedance of the ablation region (tumor tissue impedance can include measuring impedance using an impedance sensor (seen as impedance detection module) during the initial non-thermal ablation treatment, Page 29, lines 9-30).
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 modified Fang to incorporate
the teachings of Davalos by including an impedance detection module configured to detect the electrical impedance of the ablation region. The motivation to do so being to measure bulk conductivity of the tissue to further perform an additional downstream treatment in response to the change in bulk tissue conductivity (Davalos, Page 30, lines 9-17).
Regarding claim 15, Fang in view of Davalos discloses the ablation system according to claim 14.
However Fang does not explicitly disclose wherein the electrical impedance is a complex impedance.
Davalos discloses wherein the electrical impedance is a complex impedance (tumor tissue impedance (seen as a complex impedance) can include measuring impedance using an impedance sensor (seen as impedance detection module) during the initial non-thermal ablation treatment, Page 29, lines 9-30).
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 modified Fang to incorporate
the teachings of Davalos by including wherein the electrical impedance is a complex impedance. The motivation to do so being to measure bulk conductivity of the tissue to further perform an additional downstream treatment in response to the change in bulk tissue conductivity (Davalos, Page 30, lines 9-17).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Lugnani et al. (US 20200222102) herein referred to as “Lugnani”.
Regarding claim 16, Fang discloses the ablation system according to claim 1.
However Fang does not explicitly disclose wherein the characteristic of the ablation region is a PH level of the ablation region.
Lugnani discloses a cryosurgical system for ablation (Abstract) wherein the system detects the characteristic of the ablation region is a PH level of the ablation region (the pH sensor 150 may detect when the pH level at the target tissue edge has reached a pre-selected level, Paragraph [0132]).
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 modified Fang to incorporate
the teachings of Lugnani by including wherein the characteristic of the ablation region is a PH level of the ablation region. The motivation to do so being to help ensure tissue ablation at the edge and throughout the tissue site and to be a prompt for the controller to terminate electrolysis to help avoid tissue damage (Lugnani, Paragraphs [0132]-[0133]).
Conclusion
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/D.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794