DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed April 23rd, 2026 has been entered. Claims 1, 3-5, 7-10, 12, and 14-15 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed January 2nd, 2024.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-5, 7-10, 12, and 14-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
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, 3-4, 7-8, and 14 is/are rejected under 35 U.S.C. 102(a)(1)(/102(a)(2) as being anticipated by Moshe et al. (US 20100191235 A1) herein referred to as “Moshe”.
Regarding claim 1, Moshe discloses an ablation system (medical device and method for the ablation of diseased tissue, Paragraph [0002]), comprising:
a radio frequency generation module configured to generate radio frequency output (the combination of IRE and RF treatment can be performed using multiple generators or a generator with software or controls to alter the settings, Paragraph [0071]);
a pulse generation module configured to generate pulse output (the combination of IRE and RF treatment can be performed using multiple generators or a generator with software or controls to alter the settings, Paragraph [0071], IRE pulses, Paragraph [0084]);
an output control module configured to choose an ablation output mode from modes of radio frequency only output, pulse only output, and pulse and radio frequency alternating output (Or a single generator can be used where a mechanical or electrical switch was used to change from one setting to another so as to allow IRE treatment or RF treatment or both, in any combination through probe insertion, treatment, and withdrawal, Paragraph [0071], software on a computer-readable medium may be used to control certain aspects of using the devices, such as controlling power, analyzing feedback signals, and providing signals for actions, Paragraph [0076]),
according to at least one characteristic of an ablation region from characteristics of 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 a parameter of the ablation region before and after pre-test ablation (Software on a computer-readable medium may be used to control certain aspects of using the devices. Such as controlling power (e.g., amplitude, pulse frequency) to the device, analyzing feedback signals from electrodes (e.g., thermal readings, impedance, visual signals), and providing signals for actions (e.g., readiness, stand-by, power-on, power-off warnings, failure signals). For example, a Software package stored or installed on a computer-readable medium may be used for facilitating and/or enabling the methods and/or processes of using the TED devices 10. The device can be coupled to software enabling capturing data from the distal sections 32 of the electrodes such that there are feedback loops such that the software can visually demonstrate (or additionally through audio) to the user that the treatment is proceeding as planned or that there are difficulties or errors in the treatment or in the orientation or configuration of the electrodes or the position of the device. The user can use the feedback to change the treatment including the orientation of the probe, the position of the probe, the electrode configuration or orientation, the exposed electrodes, the active electrode, the insulation position, or other features to ensure proper treatment, Paragraph [0076]),
and an ablation consumable configured to perform output for the ablation region according to the ablation output mode chosen by the output control module (distal end of the therapeutic energy delivery device having four electrodes 32,35, Paragraph [0069], Figure 15, shown is the therapeutic delivery device to treat a liver tumor or other portion of undesirable tissue within a liver, the therapeutic device 10 where the elongated shaft 20 has been placed through the skin so that the distal sections 32 of the electrodes are touching a zone to be ablated 120 within a liver 114, Paragraph [0072], Figure 17).
Regarding claim 3, Moshe discloses the ablation system according to claim 1, wherein the output control module is configured that the ablation output mode of the output control module is manually chosen by an operator (The parameters can be changed manually or electronically to move from an ablation setting to parameters such that bleeding is controlled; this can be changed either through use of software or by the manual actions of the probe user, Paragraph [0079]).
Regarding claim 4, Moshe discloses the ablation system according to claim 1, wherein the output control module is configured to automatically choose the ablation output mode (Or a single generator can be used where a mechanical or electrical switch was used to change from one setting to another so as to allow IRE treatment or RF treatment or both, in any combination through probe insertion, treatment, and withdrawal, Paragraph [0071], Software on a computer-readable medium may be used to control certain aspects of using the devices. Such as controlling power (e.g., amplitude, pulse frequency) to the device, analyzing feedback signals from electrodes (e.g., thermal readings, impedance, visual signals), and providing signals for actions (e.g., readiness, stand-by, power-on, power-off warnings, failure signals). For example, a Software package stored or installed on a computer-readable medium may be used for facilitating and/or enabling the methods and/or processes of using the TED devices 10. The device can be coupled to software enabling capturing data from the distal sections 32 of the electrodes such that there are feedback loops such that the software can visually demonstrate (or additionally through audio) to the user that the treatment is proceeding as planned or that there are difficulties or errors in the treatment or in the orientation or configuration of the electrodes or the position of the device. The user can use the feedback to change the treatment including the orientation of the probe, the position of the probe, the electrode configuration or orientation, the exposed electrodes, the active electrode, the insulation position, or other features to ensure proper treatment, Paragraph [0076]).
Regarding claim 7, Moshe discloses the ablation system according to claim 1.
Moshe further discloses wherein the size of the ablation region is determined by a parameter of the pulse ablation (the total number of pulses and pulse trains can be varied based on the desired treatment outcome and effectiveness of the treatment for a given tissue (i.e., desired treatment outcome and effectiveness of treatment is the size of the ablation region), Paragraph [0084], the device can be used to tailor the type or size of the area to be treated, Paragraph [0079]).
Regarding claim 8, Moshe discloses the ablation system according to claim 7.
Moshe further 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 total number of pulses and pulse trains can be varied based on the desired treatment outcome and effectiveness of the treatment for a given tissue, Paragraph [0084]).
Regarding claim 14, Moshe discloses the ablation system according to claim 1, wherein the ablation system further comprises an impedance detection module configured to detect the electrical impedance of the ablation region (Software on a computer-readable medium may be used to control certain aspects of using the devices. Such as controlling power (e.g., amplitude, pulse frequency) to the device, analyzing feedback signals from electrodes (e.g., thermal readings, impedance, visual signals), Paragraph [0076]).
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.
Claims 5 and 9-10 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, Moshe discloses the ablation system according to claim 1.
However Moshe 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 Moshe 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 9, Moshe discloses the ablation system according to claim 1.
However Moshe 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 Moshe 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.
Moshe does disclose software for controlling power to the device (Paragraph [0076]), however Moshe 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 Moshe 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]).
Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moshe in view of Altmann et al. (US 11540877 B2) herein referred to as “Altmann”.
Regarding claim 12, Moshe discloses the ablation system according to claim 1.
However Moshe 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 Moshe 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).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Moshe in view of Davalos et al. (WO 2020061192) herein referred to as “Davalos”.
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Azure et al. (US 20160184006 A1) discloses wherein the device utilizes RF ablation and pulses to treat the tissue (Paragraph [0075]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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