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
Claims 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 10, 2026.
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) 1-2, 6-7, 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20260007466 A1 (Ruvio et al.) in view of US 20140378862 A1 (Fang et al.).
Regarding Claim 1, Ruvio teaches a microwave ablation probe [112] (see Fig. 1; see also para. 0002, “The ablation probe may be a microwave ablation probe) comprising:
a handle [114] configured to operably couple a supply cable [116] to a needle [122] (see Fig. 4; see also para. 0068);
and a printed circuit board assembly (PCBA) positioned in the handle (see para. 0086), the PCBA comprising an electrically erasable programmable read-only memory (EEPROM) device.
Ruvio does not explicitly teach the PCBA comprises an analog to digital converter. However, Fang teaches a printed circuit board assembly (PCBA) comprising an analog to digital converter (see para. 0063).
It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Ruvio in view of Fang so as to include a PCBA comprising an analog to digital converter in the handle of Ruvio. Doing so would facilitate the PCB to act in conjunction with thermocouples as a temperature measurement mechanism, as recognized by Fang.
Regarding Claim 2, Ruvio teaches the PCBA is operatively coupled to a plurality of thermocouples positioned at a plurality of locations in the microwave ablation probe (see Ruvio para. 0086).
Regarding Claim 6, Ruvio teaches a digital signal wire operably connecting the PCB to an ablation console (see para. 0086, “The PC[B] may communicate with the ablation console via the lead cable”). Ruvio does not explicitly teach a plurality of thermocouple wires each operably connecting a respective thermocouple to the PCBA, but does teach that the PCBA and the thermocouples may interface with each other (see para. 0086). Fang teaches a plurality of thermocouple wires [43, 44] each operably connecting a respective thermocouple of the plurality of thermocouples to the PCBA. It would have been obvious before the effective filing date of the claimed invention to provide for a plurality of thermocouple wires each operably connecting a respective thermocouple to the PCBA in the combination of Ruvio and Fang. Doing so would be an obvious way to achieve the desired communication between the thermocouples and the PCBA.
Regarding Claim 7, Ruvio teaches the EEPROM device is configured to store probe information characterizing a treatment performed using the microwave ablation probe (see para. 0086, “an Electrically Erasable Programmable Read-Only Memory (EEPROM) chip to store/log information relevant to the procedure”).
Regarding Claim 9 and 15, Ruvio teaches a microwave ablation apparatus comprising an ablation console [118] comprising at least one computing device (see e.g., para. 0085, “control circuitry provided at the console unit”); and the supply cable operably connecting the microwave ablation probe to the ablation console (see para. 0066, “The lead cable is connected to the console unit 118 which may act as a control unit at which the microwave ablation is controlled.”).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 20260007466 A1 (Ruvio et al.) in view of US 20140378862 A1 (Fang et al.) and further in view of US 20130296729 A1 (Datta et al.)
Regarding Claim 8, Ruvio and Fang do not explicitly teach the EEPROM device is configured to store calibration information characterizing a calibration of or testing performed for the microwave ablation probe. However, Datta teaches an EEPROM device configured to store calibration information characterizing a calibration of or testing performed for a microwave ablation probe (see para. 0030-0032, “The EEPROM is used to store various catheter specific information such as biosensor calibration information”). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Ruvio and Fang discussed above to further configure the EEPROM to store calibration information characterizing a calibration of or testing performed for the microwave ablation probe. Doing so would help verify the proper function of the device, as recognized by Datta.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 20260007466 A1 (Ruvio et al.) in view of US 20140378862 A1 (Fang et al.) and further in view of US 20130345692 A1 (Brannan et al.)
Regarding Claim 14, the combination of Ruvio and Fang does not explicitly teach the computing device is configured to compare the usage information obtained from the EEPROM device to treatment information and send a usage alert when the usage information does not correspond to the treatment information. However, Brannan teaches that device identification information from an EEPROM (such as whether the device has been used before and the time power and dosage limits of the connected microwave applicators) may be used for usage monitoring. Ruvio also teaches visual indicators (see para. 0085-0086) in communication with the device. It would have been obvious for a person having ordinary skill in the art before the effective filing date of the invention to modify the combination of Ruvio and Fang to further include for the computing device to be configured to obtain usage information from the EEPROM device, compare the usage information to treatment information, and send a usage alert (such as a visual indicator) when the usage information does not correspond to the treatment information. Doing so would be a way to more easily monitor usage of the device.
Claim(s) 1-2, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140378862 A1 (Fang et al.) in view of US 20260007466 A1 (Ruvio et al.).
Fang teaches an RF ablation probe [10] comprising:
a handle [16] configured to operably couple a supply cable [49] to a needle [12] (see Fig. 1);
and a printed circuit board assembly (PCBA) positioned in the handle (see para. 0061, “the TC signal-processing circuit 600 may be implemented by one or more circuit boards (e.g., printed circuit boards) at a catheter handle”), the PCBA comprising an analog to digital converter and an electrically erasable programmable read-only memory (EEPROM) device (see para. 0063).
Fang does not explicitly teach the RF ablation probe is specifically a microwave ablation probe. However, Ruvio teaches a microwave ablation probe [112] (see Fig. 1; see also para. 0002, “The ablation probe may be a microwave ablation probe).
It would have also been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Fang in view of Ruvio so as to provide for the probe to deliver microwave energy. Doing so is a known way to ablate tissue, as recognized by Ruvio.
Regarding Claim 2, Fang teaches the PCBA is operatively coupled to a plurality of thermocouples positioned at a plurality of locations in the microwave ablation probe (see Fang para. 0010-0013).
Regarding Claim 5, Fang teaches the analogue to digital converter is configured to receive a plurality of analog temperature signals from the plurality of thermocouples and send a digital temperature signal based on the plurality of analog temperature signals (see para. 0061).
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140378862 A1 (Fang et al.) in view of US 20260007466 A1 (Ruvio et al.) and further in view of US 20160310210 A1 (Harshman et al.).
Regarding Claim 3, Fang teaches thermocouples located in the handle (see Fig. 5; see also para. 0010-0013), but does not explicitly disclose the thermocouples being configured to determine a temperature of a supply coolant and a return coolant.
Harshman teaches thermocouples placed anywhere within a catheter assembly configured to determine a temperature of a supply coolant and a return coolant (see para. 0070). It would have been obvious before the effective filing date of the claimed invention to modify the combination of Fang and Ruvio discussed above to further include a first thermocouple located in the handle and configured to determine a temperature of a supply coolant and a second thermocouple located in the handle and configured to determine a temperature of a return coolant. Doing so would allow the coolant temperature to be manually or automatically regulated to ensure the ablation site is sufficiently heated, as recognized by Harshman (see para. 0070).
Regarding Claim 4, Fang teaches a thermocouple located in or on the needle and configured to determine a temperature near the tip electrode (see para. 0037). Additionally, Harshman teaches thermocouples in the catheter for measuring and sensing temperature at locations proximal to the electrode, which would include the needle (see para. 0016). It would have been obvious before the effective filing date of the claimed invention for the combination of Fang, Ruvio and Harshman discussed above to further include a third thermocouple located in or on the needle and configured to determine a temperature of the needle. Doing so could help monitor the temperature of the ablation site to ensure it is sufficiently heated.
Claim(s) 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140378862 A1 (Fang et al.) in view of US 20260007466 A1 (Ruvio et al.) and further in view of US 20160310210 A1 (Harshman et al.) and US 20260013937 A1 (Duff et al.)
Regarding Claim 10, the combination of Fang, Ruvio and Harshman discussed above would suggest a computing device that is configured to obtain a coolant temperature signal from the PCBA characterizing a temperature of a coolant in the handle (see Harshman para. 0070). However, Ruvio, Fang, and Harshman do not explicitly teach sending a coolant temperature alert when the temperature exceeds a predetermined coolant temperature threshold.
Duff teaches a similar energy delivery device with a mechanism for sending temperature alerts when a temperature threshold is exceeded (see para. 0042, “Based on the real-time temperature approaching, reaching, and/or exceeding the temperature threshold, the control system 102 can provide an alert informing the user that a corrective action is required).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the invention to modify the combination of Ruvio, Fang, and Harshman to further provide for sending a coolant temperature alert when the temperature exceeds a predetermined coolant temperature threshold. Doing so would facilitate corrective action at these temperature thresholds, as recognized by Duff.
Regarding Claim 12 the combination of Fang, Ruvio, and Harshman discussed above would suggest a computing device that is configured to obtain a needle temperature signal from the PCBA characterizing a temperature of the needle (see Harshman para. 0068; Fang para. 0037, 0061). However, Ruvio, Fang, and Harshman do not explicitly teach sending a needle temperature alert when the temperature exceeds a predetermined needle temperature threshold.
Duff teaches a similar energy delivery device with a mechanism for sending temperature alerts when a temperature threshold is exceeded (see para. 0042, “Based on the real-time temperature approaching, reaching, and/or exceeding the temperature threshold, the control system 102 can provide an alert informing the user that a corrective action is required).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the invention to provide for sending a needle temperature alert when the temperature exceeds a predetermined needle temperature threshold. Doing so would facilitate corrective action at particular temperature thresholds, as recognized by Duff.
Regarding Claims 11 and 13, Fang teaches obtaining thermocouple digital temperature signals from an analog to digital converter (see para. 0063-0064). As such, it would have been obvious in the combination of Ruvio, Fang, Harshman, and Duff described above for the coolant or needle temperature signals to also be a digital signal obtained from the analog to digital converter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20130345553 A1 (Arts et al.) discloses a processor unit configured to control the amount of power delivered to an antenna assembly based on time and power settings provided by the user in conjunction with sensed temperature signals from a coolant fluid, decreasing the amount of power when temperature falls below a threshold value (see para. 0107).
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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