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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 7, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al., US 20190059973, herein referred to as “Shelton”.
Regarding claim 1, Shelton discloses an electrosurgical system (Figures 2A-B), comprising: an electrosurgical instrument (Figure 2A: device 200) having at least one instrument electrode for treatment of biological tissue (Figure 2A: electrode 212); and a supply apparatus to which the electrosurgical instrument is connected (Figure 2B: generator 238), so that a closed operating circuit can be formed at least through the electrosurgical instrument and a treated tissue ([0074] and [0080]); wherein the supply apparatus is configured to provide the electrosurgical instrument with an electrical operating voltage and/or an electrical operating current ([0087]: “In use, when the generator 238 is activated, by the control system 218, the generator 238 delivers electrical energy to the electrode 212 thereby energizing the electrode 212, and consequently the cutting blade 210 so that the cutting blade 210 becomes sufficiently sharp to cut tissue.”), which is characterized by wherein at least one mode that can be set and individual ones of the at least one mode are defined by one mode parameter set of multiple mode parameters (Figure 4B); wherein the supply apparatus is additionally configured to detect at least one electrical operating parameter of the closed operating circuit (Figure 6B and [0095]); and wherein the supply apparatus is additionally configured to determine, based on the at least one electrical operating parameter, whether a treated tissue type treated by the electrosurgical instrument changes from a primary tissue type assigned to a set mode of the at least one mode to a secondary tissue type different from the primary tissue type ([0098]: “If at any time the control system determines that the measured force is greater than the predetermined force threshold F.sub.1 and the measured tissue impedance is less than the predetermined impedance threshold Z.sub.A, the end effector has therefore encountered a different tissue type, such as zone 2 or zone 3”), and in case of a determined change, the supply apparatus is configured to change at least one of the multiple mode parameters of the mode parameter set within the set mode for adaption to the secondary tissue type ([0094]: “A person of skilled art will appreciate that the cutting blade can encounter various types of tissue, e.g., as shown in FIG. 6A, and that for each type of tissue, a different amount of force should be applied to the cutting blade to allow the cutting blade to cut through the tissue, e.g., as shown in FIG. 6B. ” and [0098]).
Regarding claim 2, Shelton discloses the electrosurgical system according to claim 1, wherein individual ones of the multiple mode parameters of a respective mode parameter set comprise a defined value range within which a value of the individual ones of the multiple mode parameters is adapted (Figure 6B and [0097]).
Regarding claim 3, Shelton discloses the electrosurgical system according to claim 1, wherein the supply apparatus is configured to change the at least one mode parameter back to a value that was initially set prior to the adaption to the secondary tissue type if the supply apparatus determines, based on the at least one electrical electrically operating parameter, that the tissue type has changed again from the secondary tissue type back to the primary tissue type (Figure 6B and [0098] and [0095]-[0096]).
Regarding claim 4, Shelton discloses the electrosurgical system according to claim 1, wherein the supply apparatus is configured to change the at least one mode parameter back to a value that was initially set prior to the adaption to the secondary tissue type if a termination condition has been fulfilled (Figure 6B and [0098] and [0009]).
Regarding claim 7, Shelton discloses the electrosurgical system according to claim 1, wherein the supply apparatus is configured to change one or more of the following mode parameters, if a change of the treated tissue type has been determined: a maximum value and/or average value and/or root mean square value of the electrical operating voltage; a maximum value and/or average value and/or root mean square value of the electrical operating current ([0149]-[0150]); a crest factor of the electrical operating voltage and/or the electrical operating current; an active power and/or apparent power and/or reactive power of the electrical operating current; a power factor; a frequency and/or waveform of the electrical operating voltage; a frequency and/or waveform of the electrical operating current; and a modulation type of the electrical operating voltage and/or the electrical operating current.
Regarding claim 12, Shelton discloses the electrosurgical system according to claim 1, wherein the electrosurgical instrument and/or the supply apparatus is configured to indicate a change of a mode parameter or multiple mode parameters to an operating person ([0155]).
Regarding claim 13, Shelton discloses a method for operating an electrosurgical system (Figures 2A-B) comprising an electrosurgical instrument (Figure 2A: device 200) having at least one instrument electrode for treatment of biological tissue (Figure 2A: electrode 212) and a supply apparatus to which the electrosurgical instrument is connected (Figure 2B: generator 238) so that at least through the electrosurgical instrument and the biological tissue a closed operating circuit can be formed ([0074] and [0080]), wherein the method comprises the following steps: setting a mode that is defined by a mode parameter set of multiple mode parameters ([0010] and Figure 4B); providing an electrical operating voltage and/or an electrical operating current based on the mode for the electrosurgical instrument by the supply apparatus ([0087]: “In use, when the generator 238 is activated, by the control system 218, the generator 238 delivers electrical energy to the electrode 212 thereby energizing the electrode 212, and consequently the cutting blade 210 so that the cutting blade 210 becomes sufficiently sharp to cut tissue.”); detecting at least one electrical operating parameter of the operating circuit (Figure 6B and [0095]); determining, based on the at least one electrical operating parameter, whether a tissue type treated by the electrosurgical instrument changes from a primary tissue type assigned to the mode to a secondary tissue type different from the primary tissue type ([0098]: “If at any time the control system determines that the measured force is greater than the predetermined force threshold F.sub.1 and the measured tissue impedance is less than the predetermined impedance threshold Z.sub.A, the end effector has therefore encountered a different tissue type, such as zone 2 or zone 3”); and changing at least one of the mode parameters of the mode parameter set within the mode, in case a change of the tissue has been determined, from a primary parameter value to a value different therefrom ([0094]: “A person of skilled art will appreciate that the cutting blade can encounter various types of tissue, e.g., as shown in FIG. 6A, and that for each type of tissue, a different amount of force should be applied to the cutting blade to allow the cutting blade to cut through the tissue, e.g., as shown in FIG. 6B. ” and [0098]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Messerly et al., US 20190000478, herein referred to as “Messerly”.
Regarding claim 5, Shelton discloses the electrosurgical system according to claim 4, wherein the termination condition is fulfilled if a predefined magnitude is reached ([0115]: “If at any time during operation the control system determines that the received input meets or exceeds the predetermined magnitude, the control system can modify the output data sent to the motor based on the programmed logic functions. For example, the control system can modify the output data sent to the motor(s) to stop the current being delivered to the motor to thereby stop movement of the motor(s), and consequently, cease blade closure.”). Shelton does not explicitly disclose an electrosurgical system wherein the magnitude is a maximum duration of time that has expired since a change of one or more of the multiple mode parameters from a respective primary parameter value to a respective secondary parameter value.
However, Messerly teaches a system wherein the magnitude is a maximum duration of time that has expired since a change of one or more of the multiple mode parameters from a respective primary parameter value to a respective secondary parameter value ([0183]: “The alerts 2214 can include warnings that the tissue impedance has exceeded a maximum tissue impedance, that the electrodes have lost energy, that the measured tissue impedance is deviating from an expected tissue impedance as calculated by the controller 2102 or stored on the memory 2110, and that the application time of the RF energy has exceeded a maximum or expected time.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Shelton so that the magnitude is a maximum duration of time that has expired since a change of one or more of the multiple mode parameters from a respective primary parameter value to a respective secondary parameter value as taught by Messerly to avoid burning of tissue due to excessive electrical energy (Messerly [0368]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Pringle et al., US 20180103935, herein referred to as “Pringle”.
Regarding claim 6, Shelton discloses the electrosurgical system according to claim 1, but does not explicitly disclose a system wherein the supply apparatus is configured to distinguish connective tissue as a primary tissue type and a blood vessel as a secondary tissue type from one another.
However, Pringle teaches a system wherein the supply apparatus is configured to distinguish connective tissue as a primary tissue type and a blood vessel as a secondary tissue type from one another ([0281]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Shelton so that the supply apparatus is configured to distinguish connective tissue as a primary tissue type and a blood vessel as a secondary tissue type from one another as taught by Pringle so that the system can treat skin conditions, liver conditions, thyroid conditions, cancer, and necrosis (Pringle [0282]-[0287]).
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Legaspi et al., US 20220079652, herein referred to as “Legaspi”.
Regarding claim 8, Shelton discloses the electrosurgical system according to claim 7, but does not explicitly disclose a system wherein the supply apparatus is configured to change the mode parameters as follows if the treated tissue type treated by means of the electrosurgical instrument changes from connective tissue as primary tissue type to a blood vessel as secondary tissue type: an allowed maximum absolute value of the electrical operating voltage is reduced; an allowed maximum absolute value of the electrical operating current is increased; and a modulation type is switched from a high frequency alternating signal form for the electrical operating voltage and the electrical operating current to a quasi-continuous waveform.
However, Legaspi teaches a system wherein the supply apparatus is configured to change the mode parameters as follows if the treated tissue type treated by means of the electrosurgical instrument changes from connective tissue as primary tissue type to a blood vessel as secondary tissue type ([0170]): an allowed maximum absolute value of the electrical operating voltage is reduced (Claim 4 and Figure 15 and [0029]); an allowed maximum absolute value of the electrical operating current is increased; and a modulation type is switched from a high frequency alternating signal form for the electrical operating voltage and the electrical operating current to a quasi-continuous waveform. The claim language after “if the treated tissue type treated by the electrosurgical instrument changes from connective tissue as primary tissue type to a blood vessel as secondary tissue type” is not actively claimed because it is not required that this change from connective tissue to a blood vessel ever occurs in the operation of the system in the claim language, therefore there is no requirement that the steps that follow this claim language are disclosed by the prior art.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Shelton so that the supply apparatus is configured to change the mode parameters so that an allowed maximum absolute value of the electrical operating voltage is reduced if the treated tissue type treated by means of the electrosurgical instrument changes from connective tissue as primary tissue type to a blood vessel as secondary tissue type as taught by Legaspi so the operation of the system is based on the tissue type into which the classified living tissue is reclassified (Legaspi Abstract).
Regarding claim 9, Shelton discloses the electrosurgical system according to claim 1, but does not explicitly disclose a system wherein the supply apparatus is configured to detect the electrical operating voltage and the electrical operating current and to evaluate one or more of the following indicated operating parameters for recognition of a change of the treated tissue type: an ohmic resistance and/or impedance of the closed operating circuit; a spark parameter indicating an influence of a spark between the at least one instrument electrode of the electrosurgical instrument and the treated tissue on the electrical operating current and/or the electrical operating voltage; a maximum value and/or an average value and/or a root mean square value and/or a crest factor of the electrical operating voltage; a maximum value and/or an average value and/or a root mean square value and/or a crest factor of the electrical operating current; and an active power and/or a reactive power and/or an apparent power and/or a power factor.
However, Legaspi teaches a system wherein the supply apparatus is configured to detect the electrical operating voltage and the electrical operating current ([0027] and [0038]) and to evaluate one or more of the following indicated operating parameters for recognition of a change of the treated tissue type: an ohmic resistance and/or impedance of the closed operating circuit (Abstract); a spark parameter indicating an influence of a spark between the at least one instrument electrode of the electrosurgical instrument and the treated tissue on the electrical operating current and/or the electrical operating voltage; a maximum value and/or an average value and/or a root mean square value and/or a crest factor of the electrical operating voltage; a maximum value and/or an average value and/or a root mean square value and/or a crest factor of the electrical operating current; and an active power and/or a reactive power and/or an apparent power and/or a power factor.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Shelton so that the supply apparatus is configured to detect the electrical operating voltage and the electrical operating current and to evaluate an ohmic resistance and/or impedance of the closed operating circuit for recognition of a change of the treated tissue type as taught by Legaspi so the operation of the system is based on the tissue type into which the classified living tissue is reclassified (Legaspi Abstract).
Regarding claim 10, Shelton in view of Legaspi discloses the electrosurgical system according to claim 9, and Shelton further discloses a system wherein the supply apparatus is configured to detect a change from the primary tissue type of a connective tissue to the secondary tissue type of a blood vessel in response to: the ohmic resistance decreasing (Figure 6B and [0011]). Legaspi teaches a system wherein the supply apparatus is configured to detect a change from the primary tissue type of a connective tissue to the secondary tissue type of a blood vessel in response to: the spark parameter increasing by a minimum value within a predefined change duration of time or exceeding a predefined spark parameter threshold ([0087] wherein temperature is a spark parameter); and the power factor remaining within a predefined tolerance range ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Shelton so that the supply apparatus is configured to detect a change from the primary tissue type of a connective tissue to the secondary tissue type of a blood vessel in response to: the spark parameter increasing by a minimum value within a predefined change duration of time or exceeding a predefined spark parameter threshold; and the power factor remaining within a predefined tolerance range as taught by Legaspi so the operation of the system is based on the tissue type into which the classified living tissue is reclassified (Legaspi Abstract).
Regarding claim 11, Shelton in view of Legaspi discloses the electrosurgical system according to claim 9, and Shelton further discloses a system wherein the supply apparatus is configured to detect a change from the secondary tissue type of blood vessel to the primary tissue type of a connective tissue in response to: the ohmic resistance increasing (Figure 6B and [0011]). Legaspi teaches a system wherein the supply apparatus is configured to detect a change from the secondary tissue type of blood vessel to the primary tissue type of a connective tissue in response to the spark parameter being below a predefined spark parameter threshold during a minimum duration of time ([0087] wherein temperature is a spark parameter); and the power factor changing about a minimum absolute value within a predefined change duration of time ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Shelton so that the supply apparatus is configured to detect a change from the secondary tissue type of blood vessel to the primary tissue type of a connective tissue in response to the spark parameter being below a predefined spark parameter threshold during a minimum duration of time; and the power factor changing about a minimum absolute value within a predefined change duration of time as taught by Legaspi so the operation of the system is based on the tissue type into which the classified living tissue is reclassified (Legaspi Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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