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 .
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.
Claims 1-4, 6, 7, 15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cholette et al (2013/0218029).
Regarding claim 1, Cholette et al provide an RF ablation system and method of using, the system including a user interface including a screen (777 and Figures 3 and 4), a port for coupling to an ablation probe (Figure 7), an input/output circuitry and a controller (all encompassed in processor 770). The method of using the system includes coupling the probe to the port, the probe including a first electrode (731 – Figure 8A) and locating the device relative to the patient’s anatomy. The user interface receives an indication of the first electrode location (para. [0043], for example) and a first test signal is generated by the input/output circuitry and delivered to tissue (see paragraphs [0043] and [0053] and discussion of nerve modulation signal). The interface receives an indication of the patient response to the test signal and displays an anatomical image of the fist electrode location and the response to the first test signal (Figures 3 and 4 and para. [0041-0043], for example).
Regarding claims 2 and 3, the Cholette et al test signals are sensory test signals (i.e. nerve stimulation) that provides both a sensory test (i.e. stimulation) and a motor test (i.e. heart muscle response to the signal). Regarding claim 4, see Figures 3 and 6 which show values that are received as well as the steps of generating an innervation index map on an anatomical image of the blood vessel. Regarding claim 6, anatomical imaging information is received and displayed (Figures 4 and 6), which image is necessarily obtained from an imaging system (see para. [0043], for example). Regarding claim 7, see Figures 3 and 4 which show multiple icons.
Regarding claim 15, Cholette et al disclose an RF ablation system (para. [0050], for example) comprising a user interface, a port, input/output circuitry and a controller as discussed with respect to claim 1 above. There is a memory (772) that stores instructions to perform the steps of receiving an indication of the location of a first electrode, generating a first test signal and delivering to the probe, receiving an indication of the patient response to the test signal and presenting an anatomical image on the screen including the electrode location and the patient response to the signal. See discussion of claim 1 above.
Regarding claim 18, see Figures 3 and 4 and associated description which show the test signal results and also, paragraphs [0053-0056]. Regarding claim 19, see Figure 4 and the associated description at paragraphs [0042-0043]. Regarding claim 20, so paragraph [0043] which discloses the use of imaging, such as fluoroscopic imaging.
Claims 1-7 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley (2022/0022951).
Regarding claim 1, Townley provides an RF ablation system (para. [0075], for example) comprising a user interface including a screen (112 – Figure 2), a port for coupling to an ablation probe (Figure 2), input/output circuitry for outputting electrical data via the port and sensing on or more parameters (see, for example, paragraphs [0072] and [0077]) and a controller (107 – Figure 1A). The system provides for the method comprising coupling a probe to the port (as shown in Figure 2), the probe having a first electrode (114), receiving an indication of the first electrode location (i.e. mapping as disclosed at paragraph [0148]). The input/output circuitry generates and delivers a first test signal (para. [0143] and 0189], for example). The user interface receives an indication of the patient response and presents and anatomical image including a first icon indicating the electrode location (e.g. mapping) and the patient response to the first test signal (see para. [0148] and [0156], for example).
Regarding claims 2 and 3, the Townley test signal may be considered sensory (i.e. mapping) or a motor test signal (i.e. electrical stimulus to tissue to detect muscular activation). See, for example, paragraph [0189] which discusses various different signals that may be sent and/or analyzed. Regarding claim 4, see paragraph [0191] which discusses mapping and displaying values of measured parameters on the user interface. Regarding claim 5, the Townley device may be used to image any tissue area, including the spinal column (Figure 1B, for example). Regarding claim 6, see again paragraph [0191] which discusses receiving imaging information from the test signals and providing a mapping of tissue on an anatomical map. Regarding claim 7, Townley discusses the use of numerous different signals sent to various different electrodes on the end effector. Regarding claim 13, Townley also discloses the use of a second test signal that measures impedance and compares the measured impedance to a range to determine tissue characteristics that may be shown on the map. See, for example, paragraph [0191] as well as paragraphs [0151-0154]. Regarding claim 14, Townley disclose providing a display of the amplitude and pulse width of the signal being sent to tissue (para. [0212], for example).
Regarding claim 15, Townley provides an RF ablation system comprising a user interface including a screen (112), a port for coupling to an ablation probe (Figure 2), input/output circuitry and a controller (107) as addressed with respect to claim 1 above. Townley also discloses a memory (para. [0078] and [0170} for storing instructions including receiving an indication of the first electrode location, generating a first test signal, receiving a response to the test signal and presenting the user with an anatomical image and the patient response to the test signal as addressed with respect to claim 1 above.
Regarding claims 16 and 17, see discussion of claims 2 and 3 above, as well as paragraph [0187] which discusses the use of test signals to test for both sensory and motor test signals as well as a means to ablate tissue. Regarding claim 18, see paragraph [0108] which discusses the selective amplitude of the test signals that may be selected by the user. Regarding claim 19, paragraph [0148] of Townley discusses receiving an indication of the first electrode location by presenting an anatomical map and selecting a position on the map. Regarding claim 20, paragraph [0229] discusses the use of an imaging system (i.e. ultrasound) used to providing an indication of the electrode position.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schepis et al (2020/0038096), Cosman (6,241,725), Edwards et al (8,906,010) and Miller et al (8,403,925) disclose other RF ablation systems that use imaging to display the location of an electrode in the body as well as parameter values during treatment.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/ June 22, 2026
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