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 .
Response to Amendment
The preliminary amendment filed on April 22nd, 2025 has been entered. Claim 1 is canceled. Claims 2-18 are new. Claims 2-18 remain pending.
Specification
The disclosure is objected to because of the following informalities: The paragraph titled “CROSS-REFERENCE TO RELATED APPLICATIONS”, in the specification filed 04/22/2025 needs to be updated to include the current status of the parent application 16/411,565, which is now US Patent No. 12,262,934. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8, 15, & 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “wherein the approximately linear ramp rate is greater in a third stage that follows the second stage”; claim 2 introduces “increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level” and claim 4 introduces “the controller configured for controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes is configured for: controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes during a first stage, and wherein the controller configured for increasing the voltage level at the approximately linear ramp rate from the first voltage level to the second voltage level while delivering the electrosurgical energy to the electrodes is configured for: increasing the voltage level at the approximately linear ramp rate during a second stage”; it is unclear if the approximately linear ramp rate of claim 7 is the same or different than approximately linear ramp rate (as introduced in claim 2 and further limited in claim 4), which renders the claim indefinite. More specifically, claim 2 defines the approximately linear ramp rate as being between the first voltage level and the second voltage level, and claim 4 further clarifies that the approximately linear ramp rate occurs during stage 2, therefore it is unclear if the approximately linear ramp rate in the third stage (of claim 7) is also defined as being between the first voltage level and the second voltage level, or if this is a different approximately linear ramp rate. For examination purposes the examiner is considering the approximately linear ramp rate, of claim 7, to be different than the approximately linear ramp rate as introduced in claims 2 & 4. Claim 8 is rejected by virtue of its dependency on claim 7.
Claim 15 recites “wherein the first voltage level and the second voltage level are in a range of approximately 30V-80V”; it is unclear how the first voltage level and the second voltage level are in the range of approximately 30V-80V; more specifically claim 2 introduces “increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level”, and therefore it is unclear how a value from the range 30V-80V could be selected for the second voltage level that is equal to or less than a value from the range 30V-80V that is selected for the first voltage level, which renders the claim indefinite. For examination purposes the examiner is considering the first voltage level to be smaller than the second voltage level.
Claim 17 recites “wherein the first voltage level and the second voltage level are in a range of approximately 30V-80V”; it is unclear how the first voltage level and the second voltage level are in the range of approximately 30V-80V; more specifically claim 17 introduces “increasing the voltage level at an approximately linear ramp rate of approximately 0.02V/ms from the first voltage level to a second voltage level”, and therefore it is unclear how a value from the range 30V-80V could be selected for the second voltage level that is equal to or less than a value from the range 30V-80V that is selected for the first voltage level, which renders the claim indefinite. For examination purposes the examiner is considering the first voltage level to be smaller than the second voltage level. Claim 18 is rejected by virtue of its dependency on independent claim 17.
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 2, 4-5, 9, & 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takami et al. (US 20160374746 A1), hereinafter “Takami”.
Regarding claim 2, Takami discloses an electrosurgical waveform generator ([0019]; Figure 1—element 3) comprising: a signal generator configured to deliver electrosurgical energy at a voltage level ([0020]-[0022]; Figure 1—element 12) to electrodes of an electrosurgical instrument ([0019] & [0022]; Figure 1—elements 2, 7A, & 7B); and a controller ([0020]; Figure 1—element 11) configured for: controlling the signal generator to deliver the electrosurgical energy, at a first voltage level, to the electrodes ([0027] & [0036]; Figure 2—element S102; Figure 5—element “V1”) ; increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level while delivering the electrosurgical energy to the electrodes ([0028], [0029], & [0036]; Figure 2—element S105; Figure 5—element V2; controller 11 increases the voltage from voltage value V1 to a voltage value V2; the examiner is considering the linear ramp rate to be the increase of voltage between V1 & V2 over time between T1 & T2, which is shown in figure 5 as being linear); monitoring at least one electrical parameter during the delivery of electrosurgical energy ([0024]-[0025], [0028]-[0029], & [0032]-[0035]; Figures 2 & 3—element S103, S104, S105, & S106; Figure 5—element Wreal; the electric power detector 32 detects/acquires, with the passage of time, the electric power P which is output from the generator 12 based on the results by the current and voltage detectors 25 & 26, and the integration value calculator 33 calculated a measured integration value Wreal of the output electric power P); determining the monitored electrical parameter meets a threshold condition; and in response to determining that the electrical parameter meets the threshold, terminating the delivery of electrosurgical energy ([0037]; Figure 2—element S106 & S107; when the measured integration value Wreal of the electric power P reaches target stop value We the controller 11 controls the power supply and generator to stop the output of electric power from the generator).
Regarding claim 4, Takami discloses all of the limitations of claim 2, as described above.
Takami further discloses wherein the controller configured for controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes is configured for: controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes during a first stage ([0027]-[0028], [0030]-[0032], & [0036]; Figure 2—element S102-S104; Figure 5—elements “Ts”, “T1”, & “V1”; the examiner is considering the first stage to be the stage between “Ts” and “T1” (as shown in Figure 5)), and wherein the controller configured for increasing the voltage level at the approximately linear ramp rate from the first voltage level to the second voltage level while delivering the electrosurgical energy to the electrodes is configured for: increasing the voltage level at the approximately linear ramp rate during a second stage ([0028]-[0029], [0036], & [0041]; Figure 2—element S105; Figure 5—elements, “T1”, “T2”, & “V2”).
Regarding claim 5, Takami discloses all of the limitations of claim 4, as described above.
Takami further discloses wherein the first stage is a tissue impedance measurement stage ([0027]-[0028], [0030]-[0032], & [0036]; Figure 2—element S102-S103) and the second stage is a heating stage ([0028]-[0029], [0036], & [0041]; Figure 2—element S105; Figure 5—elements, “T1”, “T2”, & “V2”; the examiner is considering the increase/adjustment in voltage between V1 & V2 to the electrodes between time T1 & T2 to be a heating stage).
Regarding claim 9, Takami discloses all of the limitations of claim 4, as described above.
Takami further discloses wherein the controller is further configured for: maintaining the voltage level at a stable voltage level during a third stage that follows the second stage ([0036]; Figure 5—elements “T2”, “T3”, & “V2”; the controller maintains the voltage V at voltage value V2 during a period of time between T2 & T3; the examiner is considering the third stage to be the stage defined by time period between T2 & T3).
Regarding claim 12, Takami discloses all of the limitations of claim 2, as described above.
Takami further discloses wherein the at least one monitored electrical parameter includes at least one of impedance and current ([0024]-[0025], [0028]-[0029], & [0032]-[0035]; Figures 2 & 3—element S103, S104, S105, & S106; Figure 5—element Wreal; the electric power detector 32 detects/acquires, with the passage of time, the electric power P which is output from the generator 12 based on the results by the current and voltage detectors 25 & 26, and the integration value calculator 33 calculated a measured integration value Wreal of the output electric power P).
Claims 2, 4, 9-11, & 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paton et al. (US 20020091385 A1), hereinafter “Paton”.
Regarding claim 2, Paton discloses an electrosurgical waveform generator comprising: a signal generator configured to deliver electrosurgical energy at a voltage level ([0140] & [0141]; Figure 15—element 60) to electrodes of an electrosurgical instrument ([0140] & [0141]; Figure 15—elements 11); and a controller ([0142]; Figure 15—element 70) configured for: controlling the signal generator to deliver the electrosurgical energy, at a first voltage level, to the electrodes ([0060]-[0063], [0124], & [0141]; the voltage is configured to increase from a starting value of 0 to a preset maximum level; the examiner is considering the first voltage level to be a voltage level that is in between the starting value of 0 and the preset maximum level (e.g. a voltage level that is half-way in between 0V and the preset maximum level)); increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level while delivering the electrosurgical energy to the electrodes ([0060]-[0063], [0124], & [0141]; voltage on the electrodes is raised from a starting value to a preset maximum level, the rate of voltage increase is preferably the same throughout so that it appears as a straight line or ramp on a graph of voltage vs time; the examiner is considering the second voltage level to be the preset maximum level and the approximately linear ramp rate to be defined by the rate of increase in voltage between the first voltage level (e.g. a voltage level that is half-way in between 0V and the preset maximum level) and the second voltage level (e.g. the preset maximum level)); monitoring at least one electrical parameter during the delivery of electrosurgical energy; determining the monitored electrical parameter meets a threshold condition; and in response to determining that the electrical parameter meets the threshold, terminating the delivery of electrosurgical energy ([0129]-[0133]; the voltage is applied until a preset value of tissue impedance is reached, at which time the current flow is stopped).
Regarding claim 4, Paton discloses all of the limitations of claim 2, as described above.
Paton further discloses wherein the controller configured for controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes is configured for: controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes during a first stage ([0060]-[0063], [0124], & [0141]; the voltage is configured to increase from a starting value of 0 to a preset maximum level; the examiner is considering the first voltage level to be a voltage level that is in between the starting value of 0 and the preset maximum level (e.g. a voltage level that is half-way in between 0V and the preset maximum level), and the “first stage” to be the point in time at which the first voltage level is applied), and wherein the controller configured for increasing the voltage level at the approximately linear ramp rate from the first voltage level to the second voltage level while delivering the electrosurgical energy to the electrodes is configured for: increasing the voltage level at the approximately linear ramp rate during a second stage ([0060]-[0063], [0124], & [0141]; voltage on the electrodes is raised from a starting value to a preset maximum level, the rate of voltage increase is preferably the same throughout so that it appears as a straight line or ramp on a graph of voltage vs time; the examiner is considering the second voltage level to be the preset maximum level, the approximately linear ramp rate to be defined by the rate of increase in voltage between the first voltage level (e.g. a voltage level that is half-way in between 0V and the preset maximum level) and the second voltage level (e.g. the preset maximum level), and the “second stage” to be the time frame during the approximately linear ramp rate, as defined above).
Regarding claim 9, Paton discloses all of the limitations of claim 4, as described above.
Paton further discloses wherein the controller is further configured for: maintaining the voltage level at a stable voltage level during a third stage that follows the second stage ([0060]-[0063], & [0124]; after the preset maximum voltage level is reached (e.g. the second voltage level), the maximum level reached is the voltage used for a subsequent stage and the applied voltage in the subsequent stage is constant; the examiner is considering the “third stage” to be the time period defined after the second voltage level (e.g. the preset maximum voltage level) is reached where the system then applies the maximum voltage level at a steady/constant level).
Regarding claim 10, Paton discloses all of the limitations of claim 4, as described above.
Paton further discloses wherein the controller is further configured for: maintaining the voltage level at a maximum voltage level during a third stage that follows the second stage ([0060]-[0063], & [0124]; after the preset maximum voltage level is reached (e.g. the second voltage level), the maximum level reached is the voltage used for a subsequent stage and the applied voltage in the subsequent stage is constant; the examiner is considering the “third stage” to be the time period defined after the second voltage level (e.g. the preset maximum voltage level) is reached where the system then applies the maximum voltage level at a steady/constant level).
Regarding claim 11, Paton discloses all of the limitations of claim 10, as described above.
Paton further discloses wherein the maximum voltage level is less than approximately 120V ([0060]-[0063], [0124], [0141]; the output voltage that can be controlled to any level between 0 and 100 volts).
Regarding claim 15, as best understood in view of the 112(b) rejection above, Paton discloses all of the limitations of claim 2, as described above.
Paton further discloses wherein the first voltage level and the second voltage level are in a range of approximately 30V-80V ([0060]-[0063], [0124], [0141], [0151], & “Table 1”; the examiner is considering the first voltage level to be a voltage level that is in between the starting value of 0 and the preset maximum level (e.g. a voltage level that is half-way in between 0V and the preset maximum level), and the second voltage level to be the preset maximum level; the output voltage that can be controlled to any level between 0 and 100 volts (as the output voltage can be between any level between 0 and 100 volts it is the examiners position that the first voltage level and the second voltage level could be selected to be in the range of 30V-80V, as this range is within 0 and 100 volts).
Claims 2, 4, 7-8, 12, & 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayashida et al. (WO2017018025), hereinafter “Hayashida”; the examiner notes that all citations made in reference to Hayashida are in reference to the USPGPub of Hayashida (US 20170303988 A1), which comprises the same disclosure in English.
Regarding claim 2, Hayashida discloses an electrosurgical waveform generator ([0024]; Figures 1 & 2—element 200) comprising: a signal generator configured to deliver electrosurgical energy at a voltage level ([0030] & [0032]; Figure 2—element 220) to electrodes of an electrosurgical instrument ([0025], [0026], & [0032]; Figures 1 & 2—elements 112 & 114); and a controller ([0030-[0032]; Figure 2—element 210) configured for: controlling the signal generator to deliver the electrosurgical energy, at a first voltage level, to the electrodes ([0040], [0043], [0044], [0047]-[0052, & [0055]]; Figure 3—element S102 & S103; Figure 4—elements “First control”, “Second control”, & “Voltage”; Figure 5—elements S201; Figure 7—element S301 & S302; see figure below; the examiner is considering the first voltage level to be the voltage level applied at the end of the “First control” and beginning of the “Second control” (e.g. the starting voltage of the voltage increase of the Second control)); increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level while delivering the electrosurgical energy to the electrodes ([0040], [0041], [0044], [0053]-[0055], [0057]-[0058], & [0062]-[0067]; Figure 3—element S103; Figure 4—elements “Second control” & “Voltage”; Figure 7—element S302; see figure below; the examiner is considering the linear ramp rate to be the voltage increasing linearly in the “second control”); monitoring at least one electrical parameter during the delivery of electrosurgical energy ([0040], [0068] & [0097]-[0103]; Figure 3—S104; Figure 7—element S405 & S406); determining the monitored electrical parameter meets a threshold condition; and in response to determining that the electrical parameter meets the threshold, terminating the delivery of electrosurgical energy ([0040], [0068] & [0097]-[0103]; Figure 3—S104; Figure 7—elements S406 & S412; the controller determines whether the measured impedance value is at the stop impedance value or more, if the measured impedance value is greater than or equal to the stop impedance value the controller causes the generator to stop the output and the supply of power is terminated).
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Regarding claim 4, Hayashida discloses all of the limitations of claim 2, as described above.
Hayashida further discloses wherein the controller configured for controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes is configured for: controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes during a first stage ([0040], [0043], [0044], [0047]-[0052, & [0055]]; Figure 3—element S102 & S103; Figure 4—elements “First control”, “Second control”, & “Voltage”; Figure 5—elements S201; Figure 7—element S301 & S302; see figure in above rejection of claim 2; the examiner is considering the first voltage level to be the voltage level applied at the end of the “First control” and beginning of the “Second control” (e.g. the starting voltage of the voltage increase of the Second control), and the “first stage” to be the point in time in which the first voltage level is applied), and wherein the controller configured for increasing the voltage level at the approximately linear ramp rate from the first voltage level to the second voltage level while delivering the electrosurgical energy to the electrodes is configured for: increasing the voltage level at the approximately linear ramp rate during a second stage ([0040], [0044], [0053]-[0055], [0057]-[0058], & [0062]-[0067]; Figure 3—element S103; Figure 4—elements “Second control” & “Voltage”; Figure 7—element S302; the examiner is considering the linear ramp rate to be the voltage increasing linearly in the “second control”, and the “second stage” to be the time frame, e.g. second control, in which the approximately linear ramp rate is applied).
Regarding claim 7, as best understood in view of the 112(b) rejection above, Hayashida discloses all of the limitations of claim 4, as described above.
Hayashida further discloses wherein the approximately linear ramp rate is greater in a third stage that follows the second stage ([0040], [0041], [0068], [0085]-[0089], & [0100]-[0103]; Figure 4—element “Third control” & “Voltage”; Figure 12; see figure below; the examiner is considering the third stage to be the third control and the approximately linear ramp rate that is greater to be the voltage ramp, as shown in the figure below).
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Regarding claim 8, Hayashida discloses all of the limitations of claim 7, as described above.
Hayashida further discloses wherein the third stage is a sealing stage ([0105] & [0108]).
Regarding claim 12, Hayashida discloses all of the limitations of claim 2, as described above.
Hayashida further discloses wherein the at least one monitored electrical parameter includes at least one of impedance and current ([0040], [0068] & [0097]-[0103]; Figure 3—S104; Figure 7—elements S405 & S406).
Regarding claim 16, Hayashida discloses all of the limitations of claim 2, as described above.
Hayashida further discloses wherein before controlling the signal generator to deliver the electrosurgical energy, at the first voltage level, to the electrodes, the controller is further configured for: controlling the signal generator to deliver the electrosurgical energy, at an initial voltage level that exceeds the first voltage level, to the electrodes ([0040], [0041], & [0047]-[0052]; Figure 3—element S102; Figure 4—elements “Voltage” & “First Control”; Figure 5—element S201; the examiner is considering the initial voltage level to be the voltage level in the first control (see figure below)).
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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.
Claims 3 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Takami in view of Benamou (US 20140025061 A1), hereinafter “Benamou”.
Regarding claim 3, Takami discloses all of the limitations of claim 2, as described above.
Takami does not disclose wherein the approximately linear ramp rate is approximately 0.02V/ms.
Benamou teaches an RF energy system for sealing tissue comprising a controller ([0025]; Figure 3—elements 10 & 112) configured to increase the voltage at an approximately linear ramp rate to a second voltage level ([0039] & [0041]; Figure 4—element 202), wherein the approximately linear ramp rate is approximately 0.02V/ms ([0041]; the ramping voltage increases at a value in a range of 10 volts/second (e.g. 0.01V/ms) to about 100 volts/second).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the approximately linear ramp rate, as disclosed by Takami, to include wherein the approximately linear ramp rate is approximately 0.02V/ms, as taught by Benamou, as both references and the claimed invention are directed toward RF energy systems for sealing tissue comprising a controller configured to ramp the voltage at a linear ramp rate. As disclosed by Benamou, the voltage may be ramped at a rate with a value in the range of 10 volts/second to 100 volts/second ([0041]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the approximately linear ramp rate, as disclosed by Takami, to include wherein the approximately linear ramp rate is approximately 0.02V/ms, as taught by Benamou, as such a modification would provide for a known and suitable linear ramp rate for voltage in a tissue sealing system, and further it would have been obvious to one of ordinary skill in the art at the time the invention was made to include wherein the approximately linear ramp rate is approximately 0.02V/ms, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 6, Takami discloses all of the limitations of claim 4, as described above.
Takami does not disclose wherein the approximately linear ramp rate is approximately 0.02V/ms during the second stage.
Benamou teaches an RF energy system for sealing tissue comprising a controller ([0025]; Figure 3—elements 10 & 112) configured to increase the voltage at an approximately linear ramp rate to a second voltage level ([0039] & [0041]; Figure 4—element 202), wherein the approximately linear ramp rate is approximately 0.02V/ms during the second stage ([0041]; the ramping voltage increases at a value in a range of 10 volts/second (e.g. 0.01V/ms) to about 100 volts/second).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the approximately linear ramp rate, as disclosed by Takami, to include wherein the approximately linear ramp rate is approximately 0.02V/ms during the second stage, as taught by Benamou, as both references and the claimed invention are directed toward RF energy systems for sealing tissue comprising a controller configured to ramp the voltage at a linear ramp rate. As disclosed by Benamou, the voltage may be ramped at a rate with a value in the range of 10 volts/second to 100 volts/second ([0041]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the approximately linear ramp rate, as disclosed by Takami, to include wherein the approximately linear ramp rate is approximately 0.02V/ms during the second stage, as taught by Benamou, as such a modification would provide for a known and suitable linear ramp rate for voltage in a tissue sealing system, and further it would have been obvious to one of ordinary skill in the art at the time the invention was made to include wherein the approximately linear ramp rate is approximately 0.02V/ms during the second stage, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Takami in view of Yates (US 5558671 A), hereinafter “Yates”.
Regarding claims 13-14, Takami discloses all of the limitations of claim 2, as described above.
Takami does not disclose wherein the controller is further configured for: monitoring for a short circuit condition; and monitoring for an open circuit condition (claim 13); wherein the controller is further configured for: determining that either the short circuit condition or the open circuit condition is present; and in response to determining that either the short circuit condition or the open circuit condition is present, terminating the delivery of electrosurgical energy (claim 14).
Yates teaches an electrosurgical waveform generator for delivering bipolar RF energy to tissue comprising a controller ([Col. 6, lines 15-33]); wherein the controller is further configured for: monitoring for a short circuit condition; and monitoring for an open circuit condition (claim 13) ([Col. 6, line 60 – Col. 7, line 20]; impedance monitoring determines whether a short circuit or open circuit condition exists); wherein the controller is further configured for: determining that either the short circuit condition or the open circuit condition is present; and in response to determining that either the short circuit condition or the open circuit condition is present, terminating the delivery of electrosurgical energy (claim 14) ([Col. 9, lines 12-27]; if a short circuit or an open circuit condition exists the RF energy is automatically turned off by the controller).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the electrosurgical waveform generator, as disclosed by Takami, to include wherein the controller is further configured for: determining that either the short circuit condition or the open circuit condition is present; and in response to determining that either the short circuit condition or the open circuit condition is present, terminating the delivery of electrosurgical energy, as taught by Yates, as both references and the claimed invention are directed toward electrosurgical waveform generators for delivering bipolar RF energy to tissue. As disclosed by Yates, the controller may determine if there is an open circuit or short circuit condition and automatically turn off the RF energy, as these may conditions indicate a problem with the instrument and/or tissue engaged by the instrument ([Col. 6, lines 1-11] & [Col. 9, lines 12-27]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the electrosurgical waveform generator, as disclosed by Takami, to include wherein the controller is further configured for: determining that either the short circuit condition or the open circuit condition is present; and in response to determining that either the short circuit condition or the open circuit condition is present, terminating the delivery of electrosurgical energy, as taught by Yates, as such a modification automatically stop the RF energy if there is a problem with the instrument and/or tissue engaged by the instrument.
Allowable Subject Matter
Claims 17-18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Independent claim 17 recites “An electrosurgical waveform generator comprising: a radio frequency (RF) signal generator configured to deliver electrosurgical energy at a voltage level to electrodes of a bipolar electrosurgical instrument; and a controller configured for: during a tissue impedance measurement stage, controlling the RF signal generator to deliver the electrosurgical energy, at a first voltage level, to the electrodes; during a first stage, increasing the voltage level at an approximately linear ramp rate of approximately 0.02V/ms from the first voltage level to a second voltage level while delivering the electrosurgical energy to the electrodes, wherein the first voltage level and the second voltage level are in a range of approximately 30V-80V;during a second stage that follows the first stage, maintaining the voltage level at a maximum voltage level that is less than approximately 120V; monitoring at least one electrical parameter during the delivery of electrosurgical energy; determining the monitored electrical parameter meets a threshold condition; and in response to the determining, terminating the delivery of electrosurgical energy”. The Takami reference provides a teaching for an electrosurgical waveform generator ([0019]; Figure 1—element 3) comprising: a signal generator configured to deliver electrosurgical energy at a voltage level ([0020]-[0022]; Figure 1—element 12) to electrodes of a bipolar electrosurgical instrument ([0019] & [0022]; Figure 1—elements 2, 7A, & 7B); and a controller ([0020]; Figure 1—element 11) configured for: during a tissue impedance measurement stage, controlling the signal generator to deliver the electrosurgical energy, at a first voltage level ([0027], [0028], & [0036]; Figure 2—elements S102 & S103; Figure 5—element “V1”); during a first stage, increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level while delivering the electrosurgical energy to the electrodes ([0028], [0029], & [0036]; Figure 2—element S105; Figure 5—element V2; controller 11 increases the voltage from voltage value V1 to a voltage value V2; the examiner is considering the linear ramp rate to be the increase of voltage between V1 & V2 over time between T1 & T2, which is shown in figure 5 as being linear); during a second stage that follows the first stage, maintaining the voltage level ([0036]; Figure 5—elements “V2”, “T2”, & “T3”); monitoring at least one electrical parameter during the delivery of electrosurgical energy ([0024]-[0025], [0028]-[0029], & [0032]-[0035]; Figures 2 & 3—element S103, S104, S105, & S106; Figure 5—element Wreal; the electric power detector 32 detects/acquires, with the passage of time, the electric power P which is output from the generator 12 based on the results by the current and voltage detectors 25 & 26, and the integration value calculator 33 calculated a measured integration value Wreal of the output electric power P); determining the monitored electrical parameter meets a threshold condition; and in response to the determining, terminating the delivery of electrosurgical energy ([0037]; Figure 2—element S106 & S107; when the measured integration value Wreal of the electric power P reaches target stop value We the controller 11 controls the power supply and generator to stop the output of electric power from the generator); however, the Takami reference does not provide a teaching for a radio frequency (RF) signal generator; increasing the voltage level at the approximately linear ramp rate of approximately 0.02V/ms; wherein the first voltage level and the second voltage level are in a range of approximately 30V-80V; during the second stage maintaining the voltage level at a maximum voltage level that is less than approximately 120V. The Paton reference provides a teaching for an electrosurgical waveform generator comprising: a signal generator configured to deliver electrosurgical energy at a voltage level ([0140] & [0141]; Figure 15—element 60) to electrodes of a bipolar electrosurgical instrument ([0140] & [0141]; Figure 15—elements 11); and a controller ([0142]; Figure 15—element 70) configured for: controlling the RF signal generator to deliver the electrosurgical energy, at a first voltage level, to the electrode ([0060]-[0063], [0124], & [0141]; the voltage is configured to increase from a starting value of 0 to a preset maximum level; the examiner is considering the first voltage level to be a voltage level that is in between the starting value of 0 and the preset maximum level (e.g. a voltage level that is half-way in between 0V and the preset maximum level)); increasing the voltage level at an approximately linear ramp rate from the first voltage level to a second voltage level while delivering the electrosurgical energy to the electrodes ([0060]-[0063], [0124], & [0141]; voltage on the electrodes is raised from a starting value to a preset maximum level, the rate of voltage increase is preferably the same throughout so that it appears as a straight line or ramp on a graph of voltage vs time; the examiner is considering the second voltage level to be the preset maximum level and the approximately linear ramp rate to be defined by the rate of increase in voltage between the first voltage level (e.g. a voltage level that is half-way in between 0V and the preset maximum level) and the second voltage level (e.g. the preset maximum level)), wherein the first voltage level and the second voltage level are in a range of approximately 30V-80V ([0141]); during a second stage that follows the first stage, maintaining the voltage level at a maximum voltage level that is less than approximately 120V ([0060]-[0063], [0124], & [0141]); monitoring at least one electrical parameter during the delivery of electrosurgical energy; determining the monitored electrical parameter meets a threshold condition; and in response to the determining, terminating the delivery of electrosurgical energy ([0129]-[0133]; the voltage is applied until a preset value of tissue impedance is reached, at which time the current flow is stopped); however, the Paton reference does not provide a teaching for a radio frequency (RF) signal generator; during a tissue impedance measurement stage, controlling the RF signal generator to deliver the electrosurgical energy, at the first voltage level; increasing the voltage level at an approximately linear ramp rate of approximately 0.02V/ms. The Benamou reference provides a teaching for a radio frequency (RF) signal generator ([0021]) and increasing the voltage level at an approximately linear ramp rate of approximately 0.02V/ms ([0041]). However, none of the reference above provide a teaching for the combination of stages, voltage values, ramp rates are required by independent claim 17. The examiner notes that no other reference or combination of references have been found to disclose, fairly suggest, or make obvious each and every limitation set forth in independent claim 17. Dependent claim 18 is also indicated as containing allowable subject matter as it depends from independent claim 17.
Conclusion
Accordingly, claims 2-18 are rejected. Claims 17-18 would be allowable if rewritten or amended to overcome the rejection under 35 U.S.C. 112(b).
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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