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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 7/21/2026 is acknowledged.
Claims 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/21/2026.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CN2020211642244.1 on 12/31/2020. It is noted, however, that applicant has not filed a certified copy of the application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/30/2023, 6/17/2025, and 8/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
On line 4 of claim 1, “at least one perfusion channel” should read “at least one perfusion channel of the multiple perfusion channels”.
On line 5 of claim 1, “perform perfusion operation” should read “perform a perfusion operation”.
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 1-11 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.
In regard to claim 1, the same step appears to be recited at least twice. The limitation “controlling the syringe pump to open at least one perfusion channel” and “controlling the syringe pump to open or close part or all of the perfusion channels” renders the claim indefinite. It is unclear if these limitations are the same step of closing the same perfusion channel or different channels. It is also unclear if the applicant is requiring performing the step twice. For the purposes of this action, it is assumed to be essentially the same step. Applicant is encouraged to make clarifying amendments.
In further regard to claim 1, there is no antecedent basis for “the radio frequency operation data”. It is unclear how or what this data is and how is generated or determined.
In further regard to claim 1, the applicant references perfusion channels with several different variations of the term (“multiple perfusion channels”, “at least one perfusion channel”, “the perfusion channels”). It is unclear if these limitations refer to the same structure. The applicant is encouraged to make clarifying amendments that use consistent terms throughout the claims, where the term is introduced and then proper antecedent basis signifiers are used throughout the claim.
In regard to claims 3, 5, 7, and 10, the use of “ratio” renders the claim indefinite because it is unclear what the second part of the ratio is (a ratio requires comparison of two numbers while the instant claims only appear to use a single number from the temperature).
All of the dependent claims are rejected by virtue of their dependency on the rejected independent claims.
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(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hangzhou Kunbo Biotechnology Co Ltd (CN 110897710; hereafter Hangzhou) in view of Govari et al. (US 2020/0275971; hereafter Govari).
In regard to claim 1, Hangzhou discloses a radio frequency operation data control method applied to a computer terminal, for controlling a syringe pump with multiple perfusion channels (the recited invention is a method performed on a computer terminal and therefore the syringe pump is considered to be functionally recited), the method comprising steps of: controlling the syringe pump (“cold saline pump”) to open at least one perfusion channel (13) when a radio frequency operation task is triggered, so as to perform perfusion operation through the opened perfusion channel at a preset initial flow rate (“The plurality of conveying pipelines can ensure the flow of the cooling medium when the plurality of electrodes 2 carry out ablation operation, and ensure the ablation effect. In one embodiment, each delivery line flow is independently controlled.”); determining a control mode for the radio frequency operation data, and in response to that the control mode is a dual control mode, then detecting temperature values of multiple sites of a radio frequency operation object in real time (via embedded temperature sensors; “The temperature sensor is attached to or embedded in the electrode 2, so that the ablation state of the electrode 2 can be detected more accurately. Meanwhile, the electrodes 2 are provided with temperature sensors independently, and a structural basis is provided for independently controlling the ablation parameters of the electrodes 2.”); controlling the syringe pump to open or close part or all of the perfusion channels, and / or, controlling the syringe pump to adjust flow rates of part or all of the perfusion channels according to real-time changes of the temperature values of the multiple sites when the temperature values of the multiple sites exceed a preset temperature protection range (“the cold saline pump is adjusted according to the temperature of the radiofrequency instrument, if the temperature is higher than 60 ℃, the saline flow rate is increased, if the temperature is not higher than 60 ℃, the flow rate is kept unchanged, the saline flow rate is adjusted within the range of 3-15 ml/min”); controlling an output power of the radio frequency to make the temperature values of the multiple sites fall within the temperature protection range when the flow rate of the syringe pump reaches a temperature-control limit and the temperature values of the multiple sites exceed the temperature protection range (“the cold saline pump is adjusted according to the temperature of the radiofrequency instrument, if the temperature is higher than 60 ℃, the saline flow rate is increased, if the temperature is not higher than 60 ℃, the flow rate is kept unchanged, the saline flow rate is adjusted within the range of 3-15 ml/min”); and detecting impedance values of the multiple sites, and when the impedance values of the multiple sites exceed a preset impedance protection range, controlling the syringe pump to adjust the flow rates of part or all of the perfusion channels to make the impedance values of the multiple sites fall within the impedance protection range (“s200, acquiring impedance information of an electrode working circuit in an ablation process; and step S210, generating a corresponding control instruction according to the impedance information so as to adjust the flow of the cooling medium. Optionally, the method further comprises calibrating the steady-state impedance in advance, and calculating a threshold value according to the steady-state impedance, wherein the threshold value is used for being compared with the impedance information to generate a corresponding regulating cooling medium flow.”)
Hangzhou fails to disclose determining a control mode for the radio frequency data and in response to that the control mode is a dual control mode and in the dual control mode controlling the output power of the radio frequency when the flow rate of the pump reaches a temperature control limit as is recited in claim 1.
In a similar art, Govani disclose a dual control mode in order to prevent excessive temperatures when irrigation-mediated temperature regulation is insufficient. Govani discloses a first temperature decision step 70, where the processor uses temperature module 52 to check if the measured tissue temperature deviated from the allowable preset temperature range selected in step 60. If temperature decision step 70 returns a positive answer, irrigation control module 55 modifies the flow rate of irrigation to bring temperature into the allowable range, at an irrigation modification step 72. Govani further teaches at a second temperature decision step 74, the processor uses temperature module 52 to recheck if the measured tissue temperature deviated from the allowable preset temperature range selected in step 60. If temperature decision step 74 returns a positive answer, power control module 54 modifies the power to electrode 51 to bring temperature into the allowable range, at a power modification step 76. If modifications of steps 72 and 76 were unsuccessful in controlling tissue temperature according to Table I, the system halts the ablation procedure for the electrode 51 at a termination step 66. If any of decision steps 70, 74, or 78 returns a negative answer, control continues to ablation decision step 80. (see par. [0047]-[0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hangzhou with the teachings of Govani in order to provide a means for preventing overheating of tissue around an ablation site.
In regard to claim 2, the combination teaches wherein the step of controlling the syringe pump to open at least one perfusion channel when the radio frequency operation task is triggered, so as to perform perfusion operation through the opened perfusion channel at the preset initial flow rate comprises: controlling the syringe pump to randomly open one perfusion channel when the radio frequency operation task is triggered, so as to perfuse liquid into the radio frequency operation object through the opened perfusion channel at the initial flow rate; and after the step of controlling the syringe pump to randomly open one perfusion channel when the radio frequency operation task is triggered, the method further comprising: controlling a radio frequency operation catheter to perform radio frequency operation on the radio frequency operation object (both references teach controlling the temperature via delivering cooled fluid and further ablating if temperature is within range).
In regard to claim 3, Govani teaches a first temperature decision step 70, where the processor uses temperature module 52 to check if the measured tissue temperature deviated from the allowable preset temperature range selected in step 60. If temperature decision step 70 returns a positive answer, irrigation control module 55 modifies the flow rate of irrigation to bring temperature into the allowable range, at an irrigation modification step 72. Govani further teaches at a second temperature decision step 74, the processor uses temperature module 52 to recheck if the measured tissue temperature deviated from the allowable preset temperature range selected in step 60. If temperature decision step 74 returns a positive answer, power control module 54 modifies the power to electrode 51 to bring temperature into the allowable range, at a power modification step 76. If modifications of steps 72 and 76 were unsuccessful in controlling tissue temperature according to Table I, the system halts the ablation procedure for the electrode 51 at a termination step 66. If any of decision steps 70, 74, or 78 returns a negative answer, control continues to ablation decision step 80. (see par. [0047]-[0050]).
In regard to claim 4, Govani teaches, further comprising setting respective preset maximum and minimum temperatures for each of the temperature acquisition devices, and determining the first perfusion channel and the second perfusion channel according to the respective preset maximum and minimum temperatures (see par. [0004]-[0009]).
In regard to claims 5-10, Govani teaches a first temperature decision step 70, where the processor uses temperature module 52 to check if the measured tissue temperature deviated from the allowable preset temperature range selected in step 60. If temperature decision step 70 returns a positive answer, irrigation control module 55 modifies the flow rate of irrigation to bring temperature into the allowable range, at an irrigation modification step 72. Govani further teaches at a second temperature decision step 74, the processor uses temperature module 52 to recheck if the measured tissue temperature deviated from the allowable preset temperature range selected in step 60. If temperature decision step 74 returns a positive answer, power control module 54 modifies the power to electrode 51 to bring temperature into the allowable range, at a power modification step 76. If modifications of steps 72 and 76 were unsuccessful in controlling tissue temperature according to Table I, the system halts the ablation procedure for the electrode 51 at a termination step 66. If any of decision steps 70, 74, or 78 returns a negative answer, control continues to ablation decision step 80. (see par. [0047]-[0050]).
In regard to claim 11, Govani teaches wherein the step of determining the control mode for the radio frequency operation data comprises: acquiring user's setting on the control mode; in response to that the user has set the control mode, then determining the control mode for the radio frequency operation data according to the user's setting, the control mode being one of single, temperature control mode, single, impedance control mode or dual control mode; and in response to that the user has not set the control mode, then determining the dual control mode as the control mode for the radio frequency operation data (see par. [0047]-[0050]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
