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 statement (IDS) submitted on February 18, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over US 20020156472 A1 (Lee et al.).
Regarding Claim 1 and 5, Lee teaches a temperature control system for multiple radio frequency ablation needles (see para. 0014 and 0018), comprising:
N radio frequency ablation needles (see para. 0017), each radio frequency ablation needle being configured with a temperature sensor [30] for detecting a temperature value of the radio frequency ablation needle, wherein N is an integer greater than 1 (see para. 0044);
a radio frequency generator, providing radio frequency voltage to the N radio frequency ablation needles (see para. 0086);
an ablation switch array being operable to make or break an electrical connection between designated radio frequency ablation needles of the N radio frequency ablation needles and the radio frequency generator (see para. 0014);
a controller [56], coupled respectively to the temperature sensors on the N radio frequency ablation needles and the ablation switch array (see para. 0020), the controller being configured to:
obtain N temperature values from the temperature sensors on the N radio frequency ablation needles (see para. 0066), calculate a dynamical current reference temperature based on the N temperature values (e.g., the average temperatures, see para. 0068 and 0086), control the ablation switch array, such that radio frequency ablation needles with temperature values exceeding a current upper temperature limit are disconnected from the radio frequency generator, and radio frequency ablation needles with temperature values below a current lower temperature limit are connected to the radio frequency generator (see para. 0024; see also para 0071, “Incrementally, each wire 32 will have its temperature adjusted to be within the floor and ceiling range by separate voltage control).
Although Lee does not explicitly teach the controller is configured to determine a current upper temperature limit and a current lower temperature limit that is specifically based on the calculated reference temperature (e.g., the average temperatures), the system of Lee is acting to equalize temperatures, and as such, a person having ordinary skill in the art would have been motivated to modify Lee so as to further set temperature thresholds associated with an acceptable level of temperature variability between the needles (e.g., by adding and subtracting an acceptable temperature increment to the average to set the upper and lower limits respectively). Doing so would be a way to achieve the desired temperature equalization with an acceptable margin of variability.
Regarding Claim 2, Lee teaches the controller is further configured to maintain an existing connection status between a radio frequency ablation needle and the radio frequency generator if the temperature value of the radio frequency ablation needle is between the current upper temperature limit and the current lower temperature limit (see para. 0071).
Regarding Claim 3, Lee does not explicitly teach selecting M temperature values from the N temperature values to calculate an average value as the current reference temperature, wherein N>M>1, and the M temperature values include the maximum value among the N temperature values but exclude the minimum value among the N temperature values. However, Lee teaches that the temperatures should be adjusted to bring average temperatures below the temperature where charring and boiling would occur (see para. 0086). A person having ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lee so as to calculate a current reference temperature using an average value of the higher temperature electrodes only. Doing so would be a straightforward way to allow for more precise control of the highest-temperature electrodes, which are the most critical to avoid charring and boiling.
Regarding Claim 4, Lee teaches calculating an average value of the N temperature values as the current reference temperature (see para 0068; see also para. 0050).
Regarding Claim 6, Lee teaches the ablation switch array comprises N parallel ablation switches [53], respectively connected between the N radio frequency ablation needles [22] and the radio frequency generator [28], for connecting or disconnecting electrical connection between corresponding radio frequency ablation needles and the radio frequency generator (see Fig. 7).
Regarding Claim 7, Lee teaches a temperature control method for multiple radio frequency ablation needles, wherein N radio frequency ablation needles are respectively configured with temperature sensors for detecting temperature values of the radio frequency ablation needles, N is an integer greater than 1, and a radio frequency generator provides radio frequency voltage to the N radio frequency ablation needles through an ablation switch array (see para. 0014 and 0018);
the method comprising:
obtaining N temperature values from the temperature sensors on the N radio frequency ablation needles (see para. 0066), calculating a dynamical current reference temperature based on the N temperature values (e.g., the average temperatures, see para. 0068 and 0086), controlling the ablation switch array, such that radio frequency ablation needles with temperature values exceeding a current upper temperature limit are disconnected from the radio frequency generator, and radio frequency ablation needles with temperature values below a current lower temperature limit are connected to the radio frequency generator (see para. 0024; see also para 0071, “Incrementally, each wire 32 will have its temperature adjusted to be within the floor and ceiling range by separate voltage control).
Although Lee does not explicitly teach determining a current upper temperature limit and a current lower temperature limit that is specifically based on the calculated reference temperature (e.g., the average temperatures), the system of Lee is acting to equalize temperatures, and as such, a person having ordinary skill in the art would have been motivated to modify Lee so as to further set temperature thresholds associated with an acceptable level of temperature variability between the needles (e.g., by adding and subtracting an acceptable temperature increment to the average to set the upper and lower limits respectively). Doing so would be a way to achieve the temperature equalization with an acceptable margin of variability.
Regarding Claim 8, Lee teaches controlling the ablation switch array such that an existing connection status between a radio frequency ablation needle and the radio frequency generator is maintained when the temperature value of the radio frequency ablation needle is between the current upper temperature limit and the current lower temperature limit (see para. 0071).
Regarding Claim 9, Lee does not explicitly teach selecting M temperature values from the N temperature values to calculate an average value as the current reference temperature, wherein N>M>1, and the M temperature values include the maximum value among the N temperature values but exclude the minimum value among the N temperature values. However, Lee teaches that the temperatures should be adjusted to bring average temperatures below the temperature where charring and boiling would occur (see para. 0086). A person having ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lee so as to calculate a current reference temperature using an average value of the higher temperature electrodes only. Doing so would be a straightforward way to allow for more precise control of the highest-temperature electrodes, which are the most critical to avoid charring and boiling.
Regarding Claim 10, Lee does not specifically teach adjusting the output voltage according to the claimed equation:
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172
337
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Greyscale
However, Lee does teach a Proportional/Integral type controller (see para. 0078, “PI controllers are well known in the art and produce an output signal that is a function of a first control constant times the input difference signal, plus a second control constant times the integral of the input difference signal”). It is possibly to directly derive a substantially identical formula from the teachings and context of Lee, with the exception of the proportional coefficient correction parameter Cht, of which Lee is silent on. Nonetheless, it would have been obvious for a person having ordinary skill in the art would to also include this proportional coefficient. Doing so would be a way to better control the rate of temperature changes near dangerous temperature levels, such as near the points of tissue boiling or charring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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