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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in People's Republic of China on 12/09/2020. It is noted, however, that applicant has not filed a certified copy of the CN 202011433510.X application as required by 37 CFR 1.55.
Response to Amendment
The Amendment filed August 01, 2025 has been entered. Applicant’s amendments have overcome the abstract, claim, and specification objections, as well as the 112b rejections previously set-forth in the Non-Final Office Action mailed on 05/01/2025. Currently, claims 1, 3, 7, 9-10, 12-16, and 19 have been amended, claim 11 has been cancelled, and claims 1-10, 12-20 are pending in the application.
Claim Objections
Claim 15 is objected to because of the following informalities: the phrase “the preset first preset duration” in lines 4 contains an extra ‘preset’. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the word ‘filtering’ is misspelled in line 6. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the word ‘the’ is repeated twice in line 5 of page 12. 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 1-15, 17-20 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 1 recites the limitation "the impedance value and/or temperature value" in line 8. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret the impedance value and/or temperature value as the impedance sample value and/or temperature sample value described earlier in the claim in order to expedite prosecution. Claims 2-15, 17-20 are also rejected because they are dependent on claim 1.
Claim 1 recites the limitation "the impedance value and/or temperature value" in line 8. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this impedance/temperature values are different from the impedance/temperature sample values previously cited in claim 1, or if they are the same measured/monitored values. For examination purposes, Examiner will treat both impedance/temperature values the same as the impedance/temperature sample values of the perfusion control method of claim 1. Claims 2-15, 17-20 are also rejected because they are dependent on claim 1.
Claim 4 recites the limitation "the impedance value" in multiple occurrences along the claim. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this impedance values are different from the impedance sample values previously cited in claim 1, or if they are the same measured/monitored values. For examination purposes, Examiner will treat the impedance value the same as the impedance sample value of the perfusion control method of claim 1. Claims 5-6 are also rejected because they are dependent on claim 4.
Claim 5 recites the limitation "the impedance value and the temperature value" in multiple occurrences along the claim. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this impedance/temperature values are different from the impedance/temperature sample values previously cited in claim 1, or if they are the same measured/monitored values. For examination purposes, Examiner will treat both impedance/temperature values the same as the impedance/temperature sample values of the perfusion control method of claim 1.
Claim 6 recites the limitation "the impedance value" in multiple occurrences along the claim. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this impedance values are different from the impedance sample values previously cited in claim 1, or if they are the same measured/monitored values. For examination purposes, Examiner will treat the impedance value the same as the impedance sample value of the perfusion control method of claim 1.
Claim 7 recites the limitation "the impedance value and/or temperature value" in multiple occurrences along the claim. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this impedance/temperature values are different from the impedance/temperature sample values previously cited in claim 1, or if they are the same measured/monitored values. For examination purposes, Examiner will treat both impedance/temperature values the same as the impedance/temperature sample values of the perfusion control method of claim 1. Claims 8-10 are also rejected because they are dependent on claim 7.
Claim 8-10, and 13-14 recite the limitation "the impedance value or the temperature value" in multiple occurrences along the claim. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this impedance/temperature values are different from the impedance/temperature sample values previously cited in claim 1, or if they are the same measured/monitored values. For examination purposes, Examiner will treat both impedance/temperature values the same as the impedance/temperature sample values of the perfusion control method of claim 1.
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 1-10, 13-15, 17, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pearson (U.S. Application No. 20030130711 A1).
Regarding independent claim 1, Pearson discloses a perfusion control method for syringe pump (28s) (pa. 0141 & Fig. 23b), comprising:
when an ablation task is triggered, controlling the syringe pump to execute a perfusion operation on an ablation object (5`) (pa. 0139, 0142), and
acquiring an impedance sample value and/or a temperature sample value (i.e., via sensors 22) of the ablation object in real time (pa. 0134, 0108, 0155);
filtering (via subroutines or algorithms) the acquired impedance sample value and/or temperature sample value, wherein the filtered impedance sample value and/or temperature sample value are/is taken as an impedance value and/or temperature value (e.g., complex impedance, impedance vectors, impedance loci and combinations thereof) (pa. 0161);
analyzing the impedance value (e.g., via vector analysis of the impedance locus which can provide changes in the impedance over time) and/or temperature value to obtain real-time change information of the impedance value and/or temperature value (pa. 0069, 0107); and
determining a current ablation stage (i.e., any point before, during, and after an ablation procedure) according to the real-time change information of the impedance value and/or temperature value (pa. 0071, 0109);
adjusting (i.e., by controlling the flow rate or pressure of fluid released) a perfusion amount of the syringe pump dynamically according to a target adjustment logic (i.e., periodic and repeated impedance and/or temperature data received and processed by a controlling unit which compares them to a threshold) corresponding to the current ablation stage (pa. 0142, 0192).
Regarding claim 2, Pearson discloses wherein the real-time change information comprises a real-time change trend (i.e., the phase shift, which provides direction) and a real-time change amplitude (i.e., amplitude is determined by observing the complex impedance values measured, which represents the ratio of voltage amplitude to current amplitude) (pa. 0066).
Regarding claim 3, Pearson discloses wherein determining the current ablation stage according to the real-time change information is according to the real-time change trend and the real-time change amplitude of the impedance value (pa. 0058, 0071).
Regarding claim 4, as best understood, Pearson discloses wherein when the real-time acquired data comprises at least the impedance value, determining the current ablation stage according to the real-time change trend and the real-time change amplitude of the impedance value and adjusting the perfusion amount of the syringe pump according to the target adjustment logic corresponding to the current ablation stage comprises:
when the syringe pump starts to perfuse liquid into the ablation object, determining the beginning of a first ablation stage (i.e., the beginning of an ablation progress, as described in step 566) (pa. 0189 & Fig. 33), and adjusting the perfusion amount of the syringe pump according to a first target adjustment logic (i.e., the initial measurements of global or local impedance values, as described in steps 568 and 570) based on the real-time change trend and the real-time change amplitude of the impedance value (pa. 0189-0190);
when the impedance value presents a first real-time change trend (i.e., based on the initial impedance phase shift measured) and reaches a first real-time change amplitude (i.e., based on the initial complex impedance values measured and compared data stored in the controlling unit) in the first ablation stage (i.e., once tissue-confirmation is made in step 572) (pa. 0190), determining the beginning of a second ablation stage (i.e., subsequent ablation progress immediately following the initial ablation progress), and adjusting the perfusion amount of the syringe pump according to a second target adjustment logic (i.e., the subsequent measurements, after the initial measurements, of global or local impedance values and/or temperature values, as described in step 570);
when the impedance value presents a second real-time change trend (i.e., based on the subsequent impedance phase shift measured, after the initial impedance phase shift measured) and reaches a second real-time change amplitude (i.e., based on the subsequent complex impedance values measured, after the initial complex impedance value, and compared data stored in the controlling unit) in the second ablation stage, determining the beginning of a third ablation stage (i.e., any point in the ablation progress following the subsequent ablation progress), and adjusting the perfusion amount of the syringe pump according to a third target adjustment logic (i.e., any measurements values gathered and processed following the subsequent measurements of the global or local impedance values and/or temperature values, as described in steps 580 and 584) (pa. 0192-0194); and
when the impedance value presents a third real-time change trend (i.e., based on any values of the impedance phase shift measured, after the subsequent impedance phase shift measured) and reaches a third real-time change amplitude (i.e., based on any values of the complex impedance values measured, after the subsequent complex impedance value, and compared data stored in the controlling unit) in the third ablation stage, determining the beginning of a fourth ablation stage (i.e., the end of an ablation progress), and adjusting the perfusion amount of the syringe pump according to a fourth target adjustment logic (i.e., any impedance and/or temperature values measured and monitored close to the end of an ablation progress, as described in step 588) (pa. 0194-0195).
Regarding claim 5, Pearson discloses wherein when the real-time acquired data comprises the impedance value and the temperature value, adjusting the perfusion amount of the syringe pump according to the first target adjustment logic based on the real-time change trend and the real-time change amplitude of the impedance value comprises:
judging whether the impedance value presents a rising trend and reaches a preset first increase (i.e., an initial increase in impedance, as measured and monitored in step 580) (pa. 0148, 0192 & Fig. 33). Due to the lack of definitive language used to define the term “judging” in the filed Specification, henceforth Examiner will be interpreting the term “judging” as any device capable of measuring, monitoring, and/or analyzing signals measured.
when the impedance value presents the rising trend but does not reach the preset first increase, judging whether the impedance value and the temperature value are stable (i.e., within acceptable levels that achieve ablation at the highest rate that does not lead to tissue charring. Moreover, impedance values can be controlled to be not only set at the optimal impedance value/range, but can also be maintained at values above or below the optimal impedance over the time course of the ablative therapy) (pa. 0148, 0192 & Fig. 23d):
when the impedance value and the temperature value are stable, controlling the syringe pump to decrease the perfusion amount according to a preset first adjustment amplitude (i.e., a selected initial impedance threshold) (pa. 0150), and returning to perform the step of judging whether the impedance value presents the rising trend and reaches the preset first increase (pa. 0192); and
when the impedance value presents the rising trend and reaches the preset first increase, controlling the syringe pump to increase the perfusion amount according to a preset second adjustment amplitude (i.e., a selected subsequent impedance threshold following the initial impedance threshold) (pa. 0150).
Regarding claim 6, Pearson discloses wherein when the impedance value presents the first real-time change trend and reaches the first real-time change amplitude in the first ablation stage, determining the beginning of the second ablation stage and adjusting the perfusion amount of the syringe pump according to the second target adjustment logic comprises:
determining the beginning of the second ablation stage when the impedance value presents the rising trend and reaches the preset second increase (i.e., a subsequent increase in impedance after the initial increase in impedance, as measured and monitored in step 580) in the first ablation stage (pa. 0148, 0192 & Fig. 33); and
controlling the syringe pump to increase the perfusion amount according to a preset third adjustment amplitude (i.e., a selected impedance threshold following the subsequent impedance threshold) (pa. 0150);
when the impedance value presents the second real-time change trend and reaches the second real-time change amplitude in the second ablation stage, determining the beginning of the third ablation stage and adjusting the perfusion amount of the syringe pump according to the third target adjustment logic comprises:
determining the beginning of the third ablation stage when the impedance value presents the rising trend and reaches the preset third increase (i.e., an increase in impedance after the subsequent increase in impedance, as measured and monitored in step 580) in the second ablation stage (pa. 0148, 0192 & Fig. 33); and
controlling the syringe pump to increase the perfusion amount according to a preset fourth adjustment amplitude (i.e., a selected impedance threshold following the subsequent impedance threshold) (pa. 0150);
when the impedance value presents third real-time change trend and reaches the third real-time change amplitude in the third ablation stage, determining the beginning of the fourth ablation stage and adjusting the perfusion amount of the syringe pump according to the fourth target adjustment logic comprises:
determining the beginning of the fourth ablation stage when the impedance value shows a falling trend and reaches a preset first decrease, and controlling the syringe pump to decrease the perfusion amount to an initial value (pa. 0148, 0195 & Fig. 23d).
Regarding claim 7, as best understood, Pearson discloses wherein analyzing the impedance value and/or temperature value to obtain the real-time change information of the impedance value and/or temperature value comprises:
analyzing whether the impedance value or the temperature value presents a rising trend or a falling trend (pa. 0192 & Fig. 32):
when the impedance value or the temperature value presents the rising trend, controlling the syringe pump to increase a perfusion flow rate according to a preset increase and a trend change of the impedance value or the temperature value (pa. 0148, 0192); and
when the impedance value or the temperature value presents the falling trend, controlling the syringe pump to decrease the perfusion flow rate according to a preset decrease and the trend change of the impedance value or the temperature value (pa. 0148, 0195 & Fig. 23d).
Regarding claim 8, as best understood, Pearson discloses wherein analyzing whether the impedance value or the temperature value presents the rising trend or the falling trend:
when the impedance value or the temperature value presents the rising trend, controlling the syringe pump to increase the perfusion flow rate according to the preset increase and the trend change of the impedance value or the temperature value (pa. 0148, 0192); and
when the impedance value or the temperature value presents the falling trend, controlling the syringe pump to decrease the perfusion flow rate according to the preset decrease and the trend change of the impedance value or the temperature value (pa. 0148, 0195 & Fig. 23d) comprises:
judging whether the impedance value or the temperature value increases according to the real-time change information (pa. 0148, 0192 & Fig. 33):
when the impedance value or the temperature value increases, controlling the syringe pump to increase the perfusion flow rate according to a preset first increase (i.e., an initial increase in impedance, as measured and monitored in step 580), and returning to perform the step of judging whether the impedance value or the impedance value increases according to the real-time change information (pa. 0192);
when the impedance value or the temperature value does not increase, judging whether the impedance value or the temperature value decreases according to the real-time change information (pa. 0155, 0182):
when the impedance value or the temperature value decreases, controlling the syringe pump to decrease the perfusion flow rate according to a preset first decrease (i.e., an initial decrease in impedance, as measured and monitored in step 588), and returning to perform the step of judging whether the impedance value or the temperature value decreases according to the real-time change information (pa. 0194-0195 & Fig. 33); and
when the impedance value or the temperature value does not decrease, returning to perform the step of judging whether the impedance value or the temperature value increases according to the real-time change information (pa. 0192).
Regarding claim 9, as best understood, Pearson discloses wherein controlling the syringe pump to increase the perfusion flow rate according to the preset increase and the trend change in the impedance value or the temperature value comprises:
when the impedance value or the temperature value is greater than a preset first threshold (i.e., a selected initial impedance threshold) (pa. 0150), controlling the syringe pump to increase the perfusion flow rate according to a preset second increase (i.e., a subsequent increase in impedance after the initial increase in impedance, as measured and monitored in step 580) (pa. 0148, 0192 & Fig. 33);
judging whether the impedance value or the temperature value continues to increase (pa. 0182):
when the impedance value or the temperature value continues to increase, calculating a third increase (i.e., an increase in impedance after the subsequent increase in impedance, as measured and monitored in step 580) according to the preset second increase and the number of adjustments to the perfusion flow rate (pa. 0057, 0092). Examiner is interpreting the device being able to measure and store impedance profiles values over the progression of the ablation procedure via the module/monitoring device (19) (pa. 0092), which is able to perform a plurality of mathematical processes using algorithms (pa. 0105), as inherently being able to calculate the number of adjustments of the flow rate;
controlling the syringe pump to increase the perfusion flow rate according to the third increase and returning to perform the step of judging whether the impedance value or the temperature value continues to increase until the perfusion flow rate increases to a preset maximum flow rate (i.e., an increased/maximum flow rate can be utilized in order to achieve to enhance the conductive of the electrodes) (pa. 0140);
when the impedance value or the temperature value does not continue to increase, judging whether the impedance value or the temperature value is less than the preset first threshold (i.e., calculated impedance values can be compared by microprocessor 350 with impedance limits) (pa. 0177):
when the impedance value or the temperature value is not less than the preset first threshold, controlling the syringe pump to increase the perfusion flow rate according to the preset second increase until the perfusion flow rate increases to the preset maximum flow rate (pa. 0140); and
when the impedance value or the temperature value is less than the preset first threshold, returning to perform the step of judging whether the impedance value or the temperature value presents the rising trend or the falling trend according to the real-time change information (pa. 0192).
Regarding claim 10, as best understood, Pearson discloses wherein controlling the syringe pump to decrease the perfusion flow rate according to the preset decrease and the trend change in the impedance value or the temperature value comprises:
when the impedance value or the temperature value is less than a preset second threshold (i.e., a selected impedance threshold, after the initial threshold) (pa. 0150), controlling the syringe pump to decrease the perfusion flow rate of the syringe pump according to a preset second decrease (i.e., an initial decrease in impedance, as measured and monitored in step 588) (pa. 0194-0195 & Fig. 33);
judging whether the impedance value or the temperature value continues to decrease:
when the impedance value or the temperature value continues to decrease, calculating a third decrease (i.e., a subsequent decrease in impedance following the initial impedance decrease, as measured and monitored in step 588) (pa. 0194-0195 & Fig. 33) according to the second decrease and the number of adjustments to the perfusion flow rate. Examiner is interpreting the device being able to measure and store impedance profiles values over the progression of the ablation procedure via the module/monitoring device (19) (pa. 0092), which is able to perform a plurality of mathematical processes using algorithms (pa. 0105), as inherently being able to calculate the number of adjustments of the flow rate;
controlling the syringe pump to decrease the perfusion flow rate according to the third decrease and returning to perform the step of judging whether the impedance value or the temperature value continues to decrease until the perfusion flow rate decreases a preset minimum flow rate (i.e., a decreased/minimum flow rate can be utilized during the final stages of the ablation progress) (pa. 0195-0196);
when the impedance value or the temperature value does not continue to decrease, judging whether the impedance value or the temperature value is greater than the preset second threshold (i.e., calculated impedance values can be compared by microprocessor 350 with impedance limits) (pa. 0177):
when the impedance value or the temperature value is not greater than the preset second threshold, controlling the syringe pump to decrease the perfusion flow rate according to the second decrease (i.e., a subsequent decrease in impedance following the initial decrease in impedance, as measured and monitored in step 588) and returning to perform the step of judging whether the impedance value or the temperature value is greater than the preset second threshold until the perfusion flow rate decreases to the preset minimum flow rate (pa. 0195-0196); and
when the impedance value or the temperature value is greater than the preset second threshold, returning to perform the step of judging whether the impedance value or the temperature value presents the rising trend or the falling trend according to the real-time change information obtained from the analysis (pa. 0192).
Regarding claim 13, as best understood, Pearson discloses wherein when the real-time change trend comprises a real-time change trend of the temperature value (i.e., increasing/rising or decreasing/lowering values) (pa. 0186) and a real-time change trend of the impedance value (i.e., a phase shift which provides direction and amplitude, which is determined by observing the complex impedance values measured and represents the ratio of voltage amplitude to current amplitude) (pa. 0066), and the real-time change amplitude comprises a real-time change amplitude of the impedance value (pa. 0066) and a real-time change amplitude of the temperature value (i.e., the maximum or minimum values of temperature) (pa. 0192), adjusting the perfusion amount of the syringe pump dynamically according to the target adjustment logic corresponding to the current ablation stage determined according to the real-time change information comprises:
analyzing whether the real-time change trend and the real-time change amplitude of the impedance value and the real-time change trend and the real-time change amplitude of the temperature value meet an adjustment condition (i.e., the periodic and repeated impedance and/or temperature data received and processed by a controlling unit) (pa. 0192):
when the real-time change trend and the real-time change amplitude of the impedance value and the real-time change trend and the real-time change amplitude of the temperature value meet the adjustment condition, adjusting the perfusion amount of the syringe pump dynamically according to the target adjustment logic corresponding to the current ablation stage determined according to the real-time change trend and the real-time change amplitude of the impedance value (pa. 0192-0193).
Regarding claim 14, as best understood, Pearson discloses wherein when the real-time change trend comprises a real-time change trend of the temperature value, and the real-time change amplitude comprises a real-time change amplitude of the impedance value and a real-time change amplitude of the temperature value, further comprising:
assigning different base values (i.e., the complex impedance measured values used for calculation and analysis by monitoring device (19), and the temperature values calculated by an impedance calculation device) (pa. 0074, 0092, 0155) and weight values (i.e., different impedance and/temperature values measure during the ablation progress) (pa. 0192) to the real-time change amplitude of the impedance value and the real-time change amplitude of the temperature value; and
calculating an adjustment amplitude according to the base values and the weight values during the process of dynamical adjustment of the perfusion amount of the syringe pump (pa. 0192);
wherein the weight value corresponding to the real-time change amplitude of the temperature value is smaller than the weight value corresponding to the real-time change amplitude of the impedance value (pa. 0190).
Regarding claim 15, as best understood, Pearson discloses further comprising:
when the temperature value is greater than a first abnormal value or less than a second abnormal value for more than a preset first duration, controlling the syringe pump to stop the perfusion operation (pa. 0177), wherein the preset first preset duration is greater than or equal to zero. Examiner is interpreting the first preset duration to be the duration of the preset first increase as claimed in claim 5. Therefore, the first preset duration is longer than zero since it lasts from the time the impedance initially increases to the subsequent increase in the impedance during the second preset increase.
Regarding claim 17, Pearson discloses an electronic apparatus, comprising:
a non-transitory memory (19mr) and a processor (339), wherein the non-transitory memory stores an executable program code (pa. 0092, 0101, 0148 & Fig. 6);
the processor is electrically coupled to the non-transitory memory, a temperature acquisition device and an impedance acquisition device (pa. 0092 & Fig. 6); and
the processor calls the executable program code stored in the non-transitory memory to execute the perfusion control method for syringe pump according to claim 1 (pa. 0140).
Regarding claim 19, Pearson discloses a radio frequency ablation system, comprising a radio frequency ablation control apparatus, a radio frequency ablation catheter (pa. 0110), a neutral electrode (i.e., ground electrode pad) (pa. 0076), a syringe pump (pa. 0114), a temperature acquisition device (342) (pa. 0171) and an impedance acquisition device (334) (pa. 0170 & Fig. 28), wherein
the radio frequency ablation control apparatus is configured for executing steps of the perfusion control method for syringe pump according to a claim 1 (pa. 0142);
the radio frequency ablation catheter is configured for executing an ablation operation on the ablation object according to a control instruction of the radio frequency ablation control apparatus (pa. 0067, 0167);
the temperature acquisition device is configured for acquiring a temperature value of the ablation object and transmitting it to the radio frequency ablation control apparatus (pa. 0167, 0169); and
the impedance acquisition device is configured for acquiring an impedance value of the ablation object and transmitting it to the radio frequency ablation control apparatus (pa. 0191).
Regarding claim 20, Pearson discloses a non-transitory computer-readable storage medium (19mr) on which a computer program is stored (pa. 0092, 0148 & Fig. 6), wherein the computer program, when executed by a processor (339), implements the perfusion control method for syringe pump according to claim 1 (pa. 0142).
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pearson as applied to claim 1 above, and further in view of Mauch (U.S. Application No. 20120116383 A1).
Regarding claim 12, Pearson discloses further comprising judging whether the filtered impedance sample value and/or temperature sample value exceed/exceeds a preset warning value range (pa. 0177) after filtering the acquired impedance sample value and/or temperature sample value (pa. 0161):
when the filtered impedance sample value and/or temperature sample value exceed/exceeds the preset warning value range, output alarm information (i.e., a warning can be given on user interface and display 336) (pa. 0177); and
when the filtered impedance sample value and/or temperature sample value do/does not exceed the preset warning value range, and taking the average value of the filtered impedance sample value and/or temperature sample value within a preset period as the impedance value and/or temperature value (pa. 0088).
However, Pearson does not disclose taking the minimum value of the impedance/temperature same values.
Mauch, in the same field of endeavor, teaches a system (10) comprising a catheter assembly (21) further comprising a plurality of sensors capable of acquiring/monitoring temperature and impedance values from the tissue prior to, simultaneous with, or after the delivery of energy (pa. 0255, 0257). Furthermore, Mauch teaches the system comprising an evaluation/feedback algorithms (31) able to calculate an average impedance/temperature value or a minimum impedance/temperature value in a predetermined period of time (pa. 0275).
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 incorporated taking the minimum value of the impedance/temperature same values for the purpose of reducing the damage to the tissue surrounding the targeted mass to be ablated.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pearson (U.S. Application No. 20030130711 A1), and further in view of Mauch (U.S. Application No. 20120116383 A1).
Regarding independent claim 16, Pearson discloses a perfusion control apparatus for syringe pump (28s) (pa. 0141 & Fig. 23b), comprising:
a control module (338) (i.e., via a feedback control system 329) configured for controlling the syringe pump to execute a perfusion operation on an ablation object when an ablation task is triggered (pa. 0140, 0173 & Fig. 28), and acquiring an impedance sample value and/or a temperature sample value of the ablation object in real time (pa. 0134, 0108, 0155);
a filtering module (i.e., subroutines or algorithms) configured for filtering the impedance sample value and/or temperature sample value (pa. 0088, 0161);
a judging module (350) configured for judging whether the impedance sample value and/or temperature sample value exceed/exceeds a preset warning value range (pa. 0177), and taking the average value of the acquired impedance sample value and/or temperature sample value within a preset period as an impedance value and/or temperature value when the acquired impedance sample value and/or temperature sample value do/does not exceed the preset warning value range (pa. 0088). Due to the lack of definitive language used to define the term “judging” in the filed Specification, henceforth Examiner will be interpreting the term “judging” as any device capable of measuring, monitoring, and/or analyzing signals measured;
an analysis module (334, 342) configured for analyzing the impedance value and/or temperature value to obtain real-time change information of the impedance value and/or temperature value (pa. 0108, 0170-0171 & Fig. 28), wherein the real-time change information comprises a real-time change trend (i.e., the phase shift, which provides direction) and a real-time change amplitude (i.e., amplitude is determined by observing the complex impedance values measured, which represents the ratio of voltage amplitude to current amplitude) (pa. 0066); and
an adjustment module (329, 338) configured for determining a current ablation stage according to the real-time change information and adjusting the perfusion amount of the syringe pump dynamically according to a target adjustment logic corresponding to the current ablation stage (pa. 0142, 0175, 0192).
However, Pearson does not disclose taking the minimum value of the impedance/temperature same values.
Mauch, in the same field of endeavor, teaches a system (10) comprising a catheter assembly (21) further comprising a plurality of sensors capable of acquiring/monitoring temperature and impedance values from the tissue prior to, simultaneous with, or after the delivery of energy (pa. 0255, 0257). Furthermore, Mauch teaches the system comprising an evaluation/feedback algorithms (31) able to calculate an average impedance/temperature value or a minimum impedance/temperature value in a predetermined period of time (pa. 0275).
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 incorporated taking the minimum value of the impedance/temperature same values for the purpose of reducing the damage to the tissue surrounding the targeted mass to be ablated.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pearson as applied to claim 1 above, and further in view of Chang (C.N. Application No. 205494439 U).
Regarding claim 18, Pearson discloses a perfusion control system for syringe pump, comprising a syringe pump (pa. 0114), a temperature acquisition device (342) (pa. 0171) and an impedance acquisition device (334) (pa. 0170 & Fig. 28);
wherein the syringe pump comprises a controller (338) coupled to the temperature acquisition device and the impedance acquisition device (see Fig. 28);
the temperature acquisition device is configured for acquiring a temperature value of the ablation object and transmitting it to the controller (pa. 0167, 0169); and
the impedance acquisition device is configured for acquiring an impedance value of the ablation object and transmitting it to the controller (pa. 0191).
However, Pearson does not explicitly disclose wherein the syringe pump comprises a syringe, a push rod and a driving device, wherein the controller is electrically coupled to the driving device, for executing the steps of the perfusion control method for syringe pump.
Chang, in the same field of endeavor, teaches a syringe infusion pump device comprising a syringe (1), a push rod (3) and a driving device (4) and a controller (page 3, line 19 & Figs. 1-2), wherein the controller is electrically coupled to the driving device for executing the steps of the perfusion control method for syringe pump (page 3, lines 32-33; page 3, last paragraph).
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 substituted the syringe pump structure of Pearson with the syringe pump configuration of Chang because they both would yield the same predictable results of automatically controlling the flow rate of a solution based on sensed parameters.
Response to Arguments
Applicant's arguments filed 08/01/2025 have been fully considered but they are not persuasive.
With regards to newly amended claim 1, Applicant argues that the Pearson reference does not disclose filtering the acquired impedance sample value and/or temperature sample value, wherein the filtered impedance sample value and/or temperature sample value are/is taken as an impedance value and/or temperature value; determining a current ablation stage according to the real-time change information of the impedance value and/or temperature value; and adjusting a perfusion amount of the syringe pump dynamically according to a target adjustment logic corresponding to the current ablation stage. Specifically, Applicant contends that Pearson does not disclose dividing the ablation into different stages according to the real-time change information of the impedance value and/or temperature value. However, Examiner, respectfully, disagrees.
Pearson discloses a perfusion control method for syringe pump (28s) (pa. 0141 & Fig. 23b), comprising;
filtering (by using subroutines or algorithms) the acquired impedance sample value, wherein the filtered impedance sample value is taken as an impedance value (e.g., complex impedance, impedance vectors, impedance loci and combinations thereof) (pa. 0161);
determining a current ablation stage according to the real-time change information of the impedance value and/or temperature value. Examiner is interpreting an ablation stage as any point before, during, and after an ablation procedure. Pearson discloses an apparatus that is configured to determine impedance, including complex impedance, before during and after an ablation in order to monitor the progress of an ablation procedure and quantitatively determine a clinical endpoint for the procedure (pa. 0071). For example, different ablation stages can be observed by the change in impedance signal intensity (510) over time, wherein the initial, middle portions, and end of an ablation process can be clearly visually distinguished in graph of Fig. 11 (pa. 0109); and
adjusting a perfusion amount of the syringe pump dynamically according to a target adjustment logic (i.e., periodic and repeated impedance and/or temperature data received and processed by a controlling unit which compares them to a threshold) corresponding to the current ablation stage (pa. 0192). For example, if the rate of temperature rise is below a selected threshold, the control unit may adjust the power and/or rate of infusion to the tissue, to enhance the rate of heating. Furthermore, the program also asks whether the measured impedance is above a desired threshold, and if the measured impedance is too low, the program will adjust the power delivery to the electrodes and/or the rate of infusion of electrolyte to the tissue. This procedure is repeated until both temperature change and impedance levels are within selected acceptable ranges. Therefore, Examiner maintains the rejection set-forth above.
With regards to newly amended claim 18, Applicant argues that the Chang reference does not disclose controlling the injection speed of the syringe based on impedance. Examiner disagrees.
Chang reference is solely used to teach the mechanical aspects of the syringe pump, specifically a push rod (3) and a driving device (4) (Figs. 1-2). Pearson already discloses a syringe that is able to control the speed or infusion rate of the injected fluid based on measure impedance and/or temperature values (pa. 0150, 0191). Therefore, Examiner maintains the rejection set-forth above.
With regards to newly amended claims 12 and 16, Applicant argues that the Pearson reference does not disclose taking the minimum value of the acquired impedance sample value and/or temperature sample value within a preset period as an impedance value and/or temperature value to control the infusion of the saline solution. Examiner finds these arguments persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mauch (U.S. Application No. 20120116383 A1).
Conclusion
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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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794