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 January 3, 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 § 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, 3-4, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being taught by US 20090275938 A1 (Roggan et al.).
Regarding Claim 1, Roggan teaches a control system configured to control the application of energy from an electrosurgical generator [10] to a robotic electrosurgical instrument [210] during a cut mode in which the electrosurgical instrument is used to cut tissue (see Fig. 1; see also para. 0002, “The invention concerns a high frequency generator for the connection of an electrosurgical instrument for cutting body tissue”), the control system being configured to:
control the electrosurgical generator to apply energy to the electrosurgical instrument during a first cut phase [T1] (see Fig. 4; see para. 0013, “a power control which is so adapted that initially for a phase for initial cutting support it causes the delivery of a high output power for initial cutting support”);
detect a trigger condition has been met during the first cut phase, wherein the trigger condition comprises the voltage applied by the electrosurgical generator to the electrosurgical instrument [210] reaching a voltage threshold (in this case, the trigger condition is the arc sensor detecting a voltage corresponding to an arc) (see Fig. 4; see also para. 0042, “To detect the arc the arc sensor 310 detects for example a dc voltage applied”);
upon detecting that the trigger condition has been met, start a timer (see para. 0055, “If ignition of an arc is detected during or after a time interval T1 a time interval T3 immediately follows);
and upon a predetermined time period [T3] elapsing after the timer has started, control the electrosurgical generator to switch from the first cut phase [T1] to a second cut phase [T4], the second cut phase differing from the first cut phase by one or more energy parameters (see para. 0055, “The time interval T3 is followed by a time interval T4 . . . involving a markedly lower power level P3”; see also Fig. 4).
Regarding Claim 3, Roggan teaches the trigger condition comprises the tissue impedance reaching or exceeding a tissue impedance threshold (see para. 0045, Arc detection can also be effected by the detection of a sudden change in impedance).
Regarding Claim 4, Roggan teaches the first cut phase [T1] differs from the second cut phase [T4] by a power limit of the power applied by the electrosurgical generator (see Fig. 4).
Regarding Claim 12, Roggan teaches the first cut phase [T1] is the application of energy at a first voltage, and wherein the second cut phase is the application of zero voltage [T4] (e.g., referring to the first T1 with an arc trigger as the first cut phase, this phase is followed by phase T4 with substantially zero power and therefore zero voltage; see Fig. 4 and para. 0058, “the lower power P3 can even be so low that it is substantially equal to zero”).
Regarding Claim 13, Roggan teaches the first voltage is a peak voltage of the cut mode (the voltage peak will correspond to power peak P1 in Fig. 4 when the generator is connected to a voltage source; see also para. 0003).
Regarding Claim 14, Roggan teaches the first voltage is lower than a peak voltage of the cut mode (e.g., the voltage level at [P2]) (see Fig. 4).
Regarding Claim 15, Roggan teaches that once the trigger condition is met, the control system is configured to apply the first voltage (e.g., the voltage at [P2]) until the predetermined time period [T3] has elapsed.
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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over US 20090275938 A1 (Roggan et al.).
Regarding Claim 2, Roggan does not explicitly teach the trigger condition comprises both: the current applied by the electrosurgical generator to the electrosurgical instrument reaching or dropping below a current threshold and the phase angle between the current and voltage applied by the electrosurgical generator to the electrosurgical instrument reaching or exceeding a phase angle threshold. However, Roggan teaches that arc detection can be designed in any desired fashion to detect the presence of an arc, and also teaches monitoring impedance as a way to do so. It would have been obvious before the effective filing date of the claimed invention to modify the teachings of Roggan so as to provide for a trigger condition that comprises both the current applied by the electrosurgical generator to the electrosurgical instrument reaching or dropping below a current threshold and the phase angle between the current and voltage applied by the electrosurgical generator to the electrosurgical instrument reaching or exceeding a phase angle threshold. Doing so would enable the current and phase shift thresholds to be used to derive (or in place of) impedance thresholds, and as such, to determine the presence or absence of an arc for the trigger.
Claim(s) 5-11 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090275938 A1 (Roggan et al.) in view of DE 3530335 A1 (Farin et al.).
Regarding Claim 5, Roggan teaches the first cut phase [T1] is the initial application of energy at a first voltage, and wherein the second cut phase is the application of energy at a second voltage (e.g., referring to the first T1 with an arc trigger as the first cut phase, this phase is preceded by T2 and followed by T4, each of which are substantially equal to zero power and therefore zero voltage; see Fig. 4 and para. 0058, “the lower power P3 can even be so low that it is substantially equal to zero”). Although Roggan does not explicitly teach the first phase includes the application of energy from zero voltage to a first voltage, such a gradual increase is taught in a similar system by Farin (see Fig. 5). It would have been obvious for person having ordinary skill in the art before the effective filing date of the claimed invention to modify Roggan to provide for a gradual increase from zero to the voltage at which arcs are expected. Doing so is an obvious way to transition between the power level [P3] and [P1] in Roggan.
Regarding Claims 16-19, it would have been likewise obvious to have the gradual increase of Farin from zero voltage to peak voltage in a transition phase between each successive cycle of Fig. 4 of Roggan. This phase of gradually increasing energy that would happen after [T4] can be considered a third cut phase, and it would have been obvious to monitor the voltage levels in this phase as a trigger condition to stop the increase in voltage as the voltage threshold where arcs can occur approaches. Using timers after a trigger to delay transition between phases would also be obvious in view of the use of timers between other phases of the cycle. After the expiration of the timer, the electrosurgical generator would switch from this third cut phase to the next cycle’s first cut phase [T1], as suggested by Fig. 4 of Roggan.
Regarding Claim 6, Roggan teaches the first voltage is a peak voltage [P1] of the cut mode, and the second voltage [P3] is lower than the first voltage (the voltage peak will correspond to the power peak P1 in Fig. 4 when the generator is connected to a voltage source to supply the power; see also para. 0003).
Regarding Claim 7, Roggan does not teach the second voltage is a peak voltage of the cut mode, and the first voltage is lower than the second voltage. However, this is a mere reversal of the two voltages as taught by Roggan and discussed in Claim 6, with peak voltage after a trigger as opposed to before it. It would have been obvious for a person having ordinary skill in the art to modify the teachings of Roggan to have the peak voltage be the second voltage instead of the first, and the control system as taught by Roggan would be capable of doing so by simply reversing the logic to increase the voltage after a trigger instead. Doing so could be preferrable, for example, to increase the performance of the cutting action after a trigger.
Regarding Claim 8, Roggan teaches the trigger condition comprises the voltage applied by the electrosurgical generator to the electrosurgical instrument reaching or exceeding a voltage threshold (see para. 0042, “To detect the arc the arc sensor 310 detects for example a dc voltage applied”);
and once the voltage threshold is reached or exceeded, the control system comprises applying the first voltage (e.g. the voltage at [P2]) until the predetermined time period [T3] has elapsed.
Regarding Claim 9, Roggan does not explicitly teach a trigger condition met during the second phase. However, a person having ordinary skill in the art could arrive at the claimed invention before the effective filing date by simply repeating the first phase prior to the long pause [T4] (i.e., when the time [T3] expires after the first trigger, increase voltage levels again to reach the level [P1] as the second phase, and only after the expiration of the next trigger and corresponding [T3] delay move on to [T4], which would now be the third phase]. Such a modification is obvious in view of Farin, which teaches these successive repetitive increases and decreases of power before the pause (see e.g., the repetition of power levels between [t12] and [tb] in Fig. 5). Doing such repetitions could be preferable in situations where long pauses of zero voltage are unnecessary between every individual arc trigger.
With the combination as described above, the combined system of Claim 9 would therefore:
detect a further trigger condition (e.g., a voltage threshold corresponding to a second arc) has been met during the second cut phase (the second iteration of [T1]);
upon detecting that the further trigger condition has been met, start a further timer (the second iteration of [T3];
and upon a further predetermined time period elapsing after the further timer has started, control the electrosurgical generator to switch from the second cut phase to a third cut phase [T4], the third cut phase differing from the second cut phase by one or more energy parameters (the first cut phase differs from the second cut phase in that the first starts from substantially zero power whereas the second starts from [P2] and they each differ from the third cut phase which stays at substantially zero power).
Regarding Claim 10, in the combination as described in Claim 9 above the third cut phase [T4] is the application of zero voltage (see Fig. 4).
Regarding Claim 11, Roggan does not explicitly teach the trigger condition comprises both: the current applied by the electrosurgical generator to the electrosurgical instrument reaching or dropping below a current threshold and the phase angle between the current and voltage applied by the electrosurgical generator to the electrosurgical instrument reaching or exceeding a phase angle threshold. However, Roggan teaches that arc detection can be designed in any desired fashion to detect the presence of an arc, and also teaches monitoring impedance as a way to do so. It would have been obvious before the effective filing date of the claimed invention to modify the teachings of Roggan so as to provide for a trigger condition that comprises both the current applied by the electrosurgical generator to the electrosurgical instrument reaching or dropping below a current threshold and the phase angle between the current and voltage applied by the electrosurgical generator to the electrosurgical instrument reaching or exceeding a phase angle threshold. Doing so would enable the current and phase shift thresholds to be used to derive (or in place of) impedance thresholds and, as such, to determine the presence or absence of an arc for the trigger.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over US 20090275938 A1 (Roggan et al.) in view of GB 2470189 A (Amoah et al.).
Regarding Claim 24, Roggan does not teach the system is further configured to output a cut complete indication, that cut complete indication being different to the video feed from a camera recording the tissue being cut. However, Amoah teaches audible tones and displays used as cut complete indications (see p.8, lines 4-11). 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 system of Roggan to also include a cut complete indication. Doing so could alert the operator of the system about the status of the procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 12042201 B2 (Henderson et al.) teaches a power-up sequence where a supply output voltage is monitored to determine whether it rises above a threshold within a predefined duration and trigger the stop or delivery of therapeutic energy accordingly with a predetermined time delay (see col. 102, lines 21-47).
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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