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 .
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.
Claim(s) 1-7 and 9-20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Behnke et al. (US 2009/0234352).
Regarding claim 1, 13 and 18, Behnke discloses a radiofrequency (RF) ablation system (fig.1, see also [0022]), comprising: an RF electrode comprising an electrode element (fig.1; electrosurgical instrument 2) and an RF electrode cable (fig.1; electrosurgical cable 4) electrically coupled to the electrode element [0022]; a split-electrode ground pad (fig.2; return electrode pad 6) comprising a first ground pad (fig.2; split return electrodes 52a), a second ground pad (fig.2; split return electrodes 52b), and a ground-pad cable (fig.2; leads 41 and 42) electrically coupled to the first and second ground pads (fig.2;see also [0033]), wherein the ground-pad cable comprises at least one first conductor (lead 41) electrically coupled to the first ground pad (fig.2, see also [0033]) and at least one second conductor (lead 42, see also [0033]) electrically coupled to the second ground pad (fig.2, see also [0033]); and an RF generator coupleable to the RF electrode and the split-electrode ground pad (fig.2), the RF generator being configured to deliver RF energy from the RF generator through the RF electrode to patient tissue of a patient to cause ablation using the split-electrode ground pad as a counter- electrode [0022], the RF generator comprising a plurality of ports configured to individually couple the RF electrode cable and the split-electrode ground pad cable to the RF generator (fig.1), a display [0023], a non-transitory memory having processor-executable instructions stored thereon [0025], and a processor coupled to the non-transitory memory [0025] and configured to execute the processor-executable instructions (fig.2, see also [0025]), the processor-executable instructions comprising a) prior to delivery of the RF energy [0039], determining a first value that is indicative of an impedance between the first ground pad and the second ground pad ([0026], b) displaying, on the display, a representation of the first value [0023], and c) repeating (the detection circuit 22 measures (continuously) the current and voltage of the monitor signal waveform, which are used by the controller 24 to determine the phase of the monitor signal waveform with respect to frequency) steps a) and b) until a termination condition is met ([0035]: “ If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)”).
Regarding claim 2, Behnke discloses the RF ablation system of claim 1, wherein the first value indicative of the impedance is the impedance [0027].
Regarding claim 3, Behnke discloses the RF ablation system of claim 1, wherein the first value indicative of the impedance is a current, a voltage, or an impedance differential [0038].
Regarding claim 4, 14 and 19, Behnke discloses the RF ablation system, wherein the termination condition comprises at least one of: a user command, an initiation of the delivery of the RF energy, a determination of the first value reaching a threshold value [0035], a determination of the first value reaching a predetermined range, or a determination that a predetermined period of time has occurred since the split-electrode ground pad has last moved [0035].
Regarding claim 5, 15 and 20, Behnke discloses the RF ablation system, wherein the representation of the first value is a display of the first value, a graph of the first value versus time, a histogram of the first value, a time- series of histograms of the first value, a moving slider that indicates the first value, or one or more lights indicating a threshold or range of the first value [0023].
Regarding claim 6, Behnke discloses the RF ablation system of claim 1, wherein the repeating comprises repeating steps a) and b) at least once per second.
Regarding claim 7, Behnke discloses the RF ablation system of claim 1, wherein determining the first value comprises applying a voltage between the first ground pad and the second ground pad [0038].
Regarding claim 9 and 16, Behnke discloses the RF ablation system wherein the displaying comprises displaying the representation using color, shading, pattern, size, text, shape, or any combination thereof to identify each of a plurality of different ranges of the first value [0023].
Regarding claim 10, Behnke discloses the RF ablation system of claim 1, wherein the instructions further comprise providing at least one of a visual message or an auditory message for at least one of the following conditions: 1) the first value is above a first threshold value or 2) the first value is below a second threshold value [0035].
Regarding claim 11 and 17, Behnke discloses the RF ablation system wherein the instructions further comprise initiating an alarm if the first value is outside of a predetermined range [0035].
Regarding claim 12, Behnke discloses the RF ablation system of claim 1, wherein the instructions further comprise initiating the determining when an associated user command is received or when the ground pad cable is received by one of the ports of the RF generator [0023].
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.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Behnke et al. (US 2009/0234352).
Regarding claim 8, Behnke discloses the split return electrodes may be of various shapes and sizes designed to maximize capacitive coupling between the VCP 150, 250 and the patient "P." [0036]. However, Behnke does not disclose the RF wherein an area of the first ground pad is at least 10 square centimeters and an area of the second ground pad is at least 10 square centimeters. It would have been an obvious matter of design choice to have a desired size including at least 10 square centimeters and an area of the second ground pad is at least 10 square centimeters since such a modification would have involved a mere change in the size of a component. A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Massmann (US 2022/0257196) teaches A system includes an ablation generator configured to provide ablation energy to the body via a catheter, and a contact quality monitor configured to provide a quality signal indicative of contact quality associated with the one or more surface body electrodes. The contact quality monitor provides an interrogation signal to the electrodes and receives a sense signal. The contact quality monitor provides a quality signal indicating a low contact quality in response to the sense signal (abstract).
Rick (US 2007/0167942) teaches split return electrodes and hardware circuits, generically called Return Electrode Contact Quality Monitors (RECQMs), were developed. These split electrodes consist of two separate conductive foils arranged as two halves of a single return electrode [0006].
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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