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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted November 1st, 2024 and March 31st, 2026 have been considered by the Examiner.
Claim Objections
Claims 2-3, 7-9 & 17-18 objected to because of the following informalities:
Claim 2, line 2: “each sub-process” should read --each sub-process of the plurality of sub-processes--,
Claim 2, line 3: “parameter of current sub-process” should read --parameter of the current sub-process--,
Claim 3, line 3: “each sub-process” should read --each sub-process of the plurality of sub-processes--,
Claim 3, line 4: “impedance of current sub-process” should read --impedance of the current sub-process--,
Claim 3, line 6: “sub-processes” should read --each sub-process of the plurality of sub-processes--,
Claim 7, line 5: “before current” should read --before the current--,
Claim 8, line 3: “parameter of current sub-process” should read --parameter of the current sub-process--,
Claim 9, line 4: “tissue closure operation” should read --a tissue closure operation--,
Claim 17, line 3: “tissue closure operation” should read --a tissue closure operation--,
Claim 18, line 3: “tissue closure operation” should read --a tissue closure operation--.
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 1-18 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.
Regarding claim 1, the claim recites “each sub-process” in line 9 and it is unclear if this is the same sub-process as the plurality of sub-processes recited in line 7 or if this is a different sub-process. For examination purposes, these are the same sub-processes and the limitation will be interpreted as “each sub-process of the plurality of sub-processes”.
Claim 1 recites the limitation "the current sub-process" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “energy” in line 13 and it is unclear if this is the same energy as the energy recited in line 2 or a different energy. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claims 2-18 are also rejected by virtue of their dependency on claim 1.
Regarding claim 5, the claim recites “energy” in line 4 and it is unclear if this is the same energy as the energy recited in claim 1, from which claim 5 depends, or is a different energy. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Regarding claim 8, the claim recites “energy” in line 2 and it is unclear if this is the same energy as the energy recited in claim 1, from which claim 8 depends, or is a different energy. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Claim 9 recites the limitation "the next sub-process" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the voltage and current" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the second harmonic" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the claim recites “a cutter” in line 3 and it is unclear if this is the same cutter or a different cutter from that recited in claim 1, from which claim 14 depends. For examination purposes, these are the same cutters and the limitation will be interpreted as “the cutter”.
Regarding claim 14, the claim recites “two electrodes” in lines 3-4 and it is unclear if these are the same electrodes as recited in claim 1, from which claim 14 depends, or if these are different electrodes. For examination purposes, these are the same electrodes and the limitation will be interpreted as “the two electrodes.
Regarding claim 14, the claim recites “energy” in line 5 and it is unclear if this is the same energy as the energy recited in claim 1, from which claim 14 depends, or is a different energy. For examination purposes, these are the same energy and the limitation will be interpreted as “the energy”.
Regarding claim 15, the claim recites “executing a plurality of sub-processes sequentially after it is determined that the tissue has been effectively clamped by the two electrodes of the cutter; during each sub-process, determining at least one control parameter and at least one ending parameter of current sub-process based on at least one impedance parameter and at least one time parameter of the tissue; and outputting energy to the tissue based on the at least one control parameter of the current sub-process, and determining whether the current sub-process should be ended based on the at least one ending parameter of the current sub-process” and it is unclear whether these steps and features are the same steps and features as recited in claim 1, from which claim 15 depends or are separate. See also 112(d) rejection of this claim, below.
Regarding claim 16, the claim recites “executing a plurality of sub-processes sequentially after it is determined that the tissue has been effectively clamped by the two electrodes of the cutter; during each sub-process, determining at least one control parameter and at least one ending parameter of current sub-process based on at least one impedance parameter and at least one time parameter of the tissue; and outputting energy to the tissue based on the at least one control parameter of the current sub-process, and determining whether the current sub-process should be ended based on the at least one ending parameter of the current sub-process” and it is unclear whether these steps and features are the same steps and features as recited in claim 1, from which claim 15 depends or are separate. See also 112(d) rejection of this claim, below.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15-16 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 15, the claim recites “executing a plurality of sub-processes sequentially after it is determined that the tissue has been effectively clamped by the two electrodes of the cutter; during each sub-process, determining at least one control parameter and at least one ending parameter of current sub-process based on at least one impedance parameter and at least one time parameter of the tissue; and outputting energy to the tissue based on the at least one control parameter of the current sub-process, and determining whether the current sub-process should be ended based on the at least one ending parameter of the current sub-process” and it is unclear how this is further limiting claim 1, from which claim 15 depends.
Regarding claim 16, the claim recites “executing a plurality of sub-processes sequentially after it is determined that the tissue has been effectively clamped by the two electrodes of the cutter; during each sub-process, determining at least one control parameter and at least one ending parameter of current sub-process based on at least one impedance parameter and at least one time parameter of the tissue; and outputting energy to the tissue based on the at least one control parameter of the current sub-process, and determining whether the current sub-process should be ended based on the at least one ending parameter of the current sub-process” and it is unclear how this is further limiting claim 1, from which claim 16 depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 & 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Unger et al. (U.S. Pub. No. 20120283731, cited in IDS), herein referred to as “Unger”.
Regarding claim 1, Unger discloses an electrosurgical generator (Abstract: An electrosurgical generator), characterized in that it comprises:
a power output module (RF output stage 8) configured to output energy to a tissue via two electrodes of a cutter ([0049]: an RF output stage 8 which then converts DC power into RF energy and delivers the RF energy to the forceps 10; [0051]: the forceps 10 applies energy through electrodes, each of the jaw members 110 and 120); and
a control module (controller 4) that is configured to:
determine at least one impedance parameter of the tissue based on sampling signals of the output energy ([0059]: In step 304, the algorithm begins with an impedance sense phase, shown as phase I in FIG. 7, during which the algorithm senses the tissue impedance with an interrogatory impedance sensing pulse of approximately 100 ms duration. The measured value of tissue impedance is stored as a variable DZDT_Start_Z. Tissue impedance is determined without appreciably changing the tissue); and
execute a plurality of sub-processes sequentially after it is determined that the tissue is effectively clamped between the two electrodes of the cutter ([0059]: During this interrogation or error-checking phase the generator 2 provides constant power to check for a short or an open circuit, in order to determine if tissue is being grasped; steps following steps 304 & 306, Fig. 6A);
wherein during each sub-process, at least one control parameter and at least one ending parameter of the current sub- process is determined based on the at least one impedance parameter of the tissue and at least one time parameter ([0066]: To identify that a tissue reaction has occurred, there are two elements which are considered. The first consideration is the minimum tissue impedance obtained during the heating period. In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow. As time progresses throughout the entire energy activation cycle, the stored value is updated anytime a new value is read that is lower than the previous Zlow, represented by phase II in FIG. 7; [0074]: step 332, the algorithm calculates a target impedance value for the control system at each time-step, based on a predefined desired rate of change of impedance (dZ/dt), represented as phase IV in FIG. 7. The desired rate of change may be stored as a variable and be loaded during the step 302; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value); and
the power output module is controlled to output energy to the tissue according to the at least one control parameter of the current sub-process ([0065]: step 310 the algorithm initiates application of the RF energy by delivering current linearly over time to heat the tissue; [0068]: step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off and the algorithm proceeds to step 360 wherein the cooling timer is activated; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value), and it is determined whether the current sub-process should be ended according to the at least one ending parameter of the current sub-process ([0068]: step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off and the algorithm proceeds to step 360 wherein the cooling timer is activated).
Regarding claim 2, Unger discloses that the control module is configured to: in each sub-process, determine at least one control parameter of current sub-process according to a minimum impedance of the tissue in a previous sub-process and a duration of the previous sub-process ([0066]: To identify that a tissue reaction has occurred, there are two elements which are considered. The first consideration is the minimum tissue impedance obtained during the heating period. In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow; [0067]: In step 316 the algorithm waits for a predetermined period of time to identify whether a rise in impedance has occurred, represented by phases IIIa and IIIb in FIG. 7; [0074]: step 332, the algorithm calculates a target impedance value for the control system at each time-step, based on a predefined desired rate of change of impedance (dZ/dt), represented as phase IV in FIG. 7. The desired rate of change may be stored as a variable and be loaded during the step 302; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value).
Regarding claim 3, Unger discloses that the control module is configured to: in each sub-process, determine an ending impedance of current sub-process according to a minimum impedance and a bias impedance of the tissue in a previous sub-process ([0066]: To identify that a tissue reaction has occurred, there are two elements which are considered. The first consideration is the minimum tissue impedance obtained during the heating period. In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow; [0068]: in step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off; [0059]: In step 304, the algorithm begins with an impedance sense phase, shown as phase I in FIG. 7, during which the algorithm senses the tissue impedance with an interrogatory impedance sensing pulse of approximately 100 ms duration. The measured value of tissue impedance is stored as a variable DZDT_Start_Z); wherein the bias impedance is a fixed value, or a value that changes with sub-processes ([0059]: In step 304, the algorithm begins with an impedance sense phase, shown as phase I in FIG. 7, during which the algorithm senses the tissue impedance with an interrogatory impedance sensing pulse of approximately 100 ms duration. The measured value of tissue impedance is stored as a variable DZDT_Start_Z; wherein the initial impedance is seen as the bias impedance).
Regarding claim 4, Unger discloses that the control module is configured to end the current sub-process if a real-time impedance of the tissue is greater than the ending impedance of the current sub-process ([0068]: in step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off).
Regarding claim 5, Unger discloses that: the control module is configured to end the current sub-process if a duration of outputting energy to the tissue according to the at least one control parameter of the current sub-process is greater than a preset timeout period ([0076]: If the sealing portion of the vessel sealing process (i.e., not including cool-down time) has exceeded a predetermined time period (e.g., maximum seal timer) which may be about 12 seconds, the algorithm exits with an alarm).
Regarding claim 6, Unger discloses that the control module is configured to end the current sub-process if a duration of the current sub-process is greater than a preset sub-process maximum duration ([0076]: If the sealing portion of the vessel sealing process (i.e., not including cool-down time) has exceeded a predetermined time period (e.g., maximum seal timer) which may be about 12 seconds, the algorithm exits with an alarm).
Regarding claim 7, Unger discloses that: the control module is further configured to: in each sub-process, determine an ending impedance at tissue closure according to a minimum impedance of the tissue in a previous sub-process, a minimum impedance of the tissue in all sub-processes before current sub- process, and an initial impedance of the tissue ([0066]: In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow. As time progresses throughout the entire energy activation cycle, the stored value is updated anytime a new value is read that is lower than the previous Zlow, represented by phase II in FIG. 7. In other words, during steps 312, 314 and 316, the generator 2 waits for the tissue impedance to drop. The generator 2 also captures EndZ_Offset impedance, which corresponds to the initial measured tissue impedance. The EndZ_Offset impedance is used to determine the threshold for terminating the procedure).
Regarding claim 8, Unger discloses that the control module is further configured to: before outputting energy to the tissue according to the at least one control parameter of current sub-process, determine whether tissue closure is completed based on a real-time impedance of the tissue and the ending impedance at tissue closure, wherein it is determined that tissue closure is completed when a real-time impedance of the tissue is greater than the ending impedance at tissue closure ([0066]: In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow. As time progresses throughout the entire energy activation cycle, the stored value is updated anytime a new value is read that is lower than the previous Zlow, represented by phase II in FIG. 7. In other words, during steps 312, 314 and 316, the generator 2 waits for the tissue impedance to drop. The generator 2 also captures EndZ_Offset impedance, which corresponds to the initial measured tissue impedance. The EndZ_Offset impedance is used to determine the threshold for terminating the procedure; [0068]: in step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value).
Regarding claim 9, Unger discloses that the control module is further configured to: in determination of ending the current sub- process, determine whether tissue closure operation has timed out ([0076]: If the sealing portion of the vessel sealing process (i.e., not including cool-down time) has exceeded a predetermined time period (e.g., maximum seal timer) which may be about 12 seconds, the algorithm exits with an alarm); and
proceed to the next sub-process when it is determined that the tissue closure operation is not timed out (see loop back to step 336 from step 340, Fig. 6B).
Regarding claim 10, Unger discloses that the control module is further configured to: obtain an initial impedance ([0059]: In step 304, the algorithm begins with an impedance sense phase) and initial phase of the tissue ([0061]: The algorithm in step 306 also monitors the phase between voltage and current), where the initial phase of the tissue is an initial value of a phase difference between the voltage and current output to the tissue by the two electrodes of the cutter ([0061]: The algorithm in step 306 also monitors the phase between voltage and current … If the measured phase is above the upper threshold, the algorithm detects an open circuit. If the measured phase is below the lower threshold, the algorithm detects a short circuit; wherein the determination of a short or open circuit is a known technique between two electrodes such that this limitation is seen as detecting a phase difference between the voltage and current output to the tissue by the two electrodes of the cutter); and
determine whether the tissue is effectively clamped by the two electrodes of the cutter based on the initial impedance and the initial phase ([0061]: The algorithm in step 306 also monitors the phase between voltage and current … If the measured phase is above the upper threshold, the algorithm detects an open circuit. If the measured phase is below the lower threshold, the algorithm detects a short circuit; wherein effectively clamped is seen as the measured phase being between the upper and lower thresholds since short circuit would mean the two electrodes are touching and open circuit would mean that the tissue is inadequately grasped).
Regarding claim 11, Unger discloses that the control module is further configured to: according to the initial phase, look up a table to obtain an impedance range corresponding to the initial impedance; determine whether the initial impedance is within its corresponding impedance range; if yes, it is determined that the tissue is effectively clamped by the two electrodes of the cutter; if not, it is determined that the tissue is not effectively clamped by the two electrodes of the cutter ([0062]: If in step 306 a short circuit is detected, e.g., impedance is below a low impedance threshold and/or phase is above the upper threshold or if a an open circuit is detected, e.g., impedance is above a high impedance threshold and/or the phase is below the lower threshold, the algorithm in step 364 issues a regrasp alarm, and the algorithm exits in step 308; wherein an algorithm is seen as comprising a look up table as it must store the thresholds).
Regarding claim 14, Unger discloses an electrosurgical system ([0038]: an electrosurgical system 1), comprising:
the electrosurgical generator according to claim 1 (generator 2, see Fig. 1); and
a cutter (forceps 10) coupled to the electrosurgical generator ([0038]: the system 1 includes an electrosurgical forceps 10 for treating patient tissue. Electrosurgical RF energy is supplied to the forceps 10 by a generator 2 via a cable 18 thus allowing the user to selectively coagulate and/or seal tissue), wherein the cutter comprises two electrodes for clamping tissue ([0039]: the end effector assembly 100 to grasp, seal and, if required, divide tissue; [0051]: the forceps 10 applies energy through electrodes, each of the jaw members 110 and 120);
wherein energy is output to the tissue by the electrosurgical generator via the two electrodes of the cutter ([0051]: the forceps 10 applies energy through electrodes, each of the jaw members 110 and 120).
Regarding claim 15, Unger discloses a control method applied to the electrosurgical generator of claim 1 ([0003]: The present disclosure relates to an electrosurgical system and method for performing electrosurgical procedures);
wherein the method comprises:
executing a plurality of sub-processes sequentially after it is determined that the tissue has been effectively clamped by the two electrodes of the cutter ([0062]: If, otherwise, no fault is detected in step 306 (i.e., no short and no open circuit detected), the algorithm starts the cook phase in step 310; see sequence of steps that occur after step 306 in Fig. 6A & wherein both short circuit and open circuit are seen as ineffective clamps as they indicate that tissue isn’t being clamped);
during each sub-process, determining at least one control parameter and at least one ending parameter of current sub-process based on at least one impedance parameter and at least one time parameter of the tissue ([0066]: To identify that a tissue reaction has occurred, there are two elements which are considered. The first consideration is the minimum tissue impedance obtained during the heating period. In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow. As time progresses throughout the entire energy activation cycle, the stored value is updated anytime a new value is read that is lower than the previous Zlow, represented by phase II in FIG. 7; [0074]: step 332, the algorithm calculates a target impedance value for the control system at each time-step, based on a predefined desired rate of change of impedance (dZ/dt), represented as phase IV in FIG. 7. The desired rate of change may be stored as a variable and be loaded during the step 302; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value); and
outputting energy to the tissue based on the at least one control parameter of the current sub-process, and determining whether the current sub-process should be ended based on the at least one ending parameter of the current sub-process ([0065]: step 310 the algorithm initiates application of the RF energy by delivering current linearly over time to heat the tissue; [0068]: step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off and the algorithm proceeds to step 360 wherein the cooling timer is activated; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value).
Regarding claim 16, Unger discloses a control method applied to the electrosurgical system according to claim 14 ([0003]: The present disclosure relates to an electrosurgical system and method for performing electrosurgical procedures); wherein the method comprises:
executing a plurality of sub-processes sequentially after it is determined that the tissue has been effectively clamped by the two electrodes of the cutter ([0062]: If, otherwise, no fault is detected in step 306 (i.e., no short and no open circuit detected), the algorithm starts the cook phase in step 310; see sequence of steps that occur after step 306 in Fig. 6A & wherein both short circuit and open circuit are seen as ineffective clamps as they indicate that tissue isn’t being clamped);
during each sub-process,
determining at least one control parameter and at least one ending parameter of current sub-process based on at least one impedance parameter and at least one time parameter of the tissue ([0066]: To identify that a tissue reaction has occurred, there are two elements which are considered. The first consideration is the minimum tissue impedance obtained during the heating period. In step 312, the algorithm continuously monitors the tissue impedance after the onset of energy to identify the lowest value reached and then in step 314 stores this value as the variable ZLow. As time progresses throughout the entire energy activation cycle, the stored value is updated anytime a new value is read that is lower than the previous Zlow, represented by phase II in FIG. 7; [0074]: step 332, the algorithm calculates a target impedance value for the control system at each time-step, based on a predefined desired rate of change of impedance (dZ/dt), represented as phase IV in FIG. 7. The desired rate of change may be stored as a variable and be loaded during the step 302; [0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value); and
outputting energy to the tissue based on the at least one control parameter of the current sub-process ([0075]: The target impedance trajectory includes a plurality of a target impedance values at each time step. The algorithm drives tissue impedance along the target impedance trajectory by adjusting the power output level to substantially match tissue impedance to a corresponding target impedance value), and determining whether the current sub-process should be ended based on the at least one ending parameter of the current sub-process ([0065]: step 310 the algorithm initiates application of the RF energy by delivering current linearly over time to heat the tissue; [0068]: step 324 the generator 2 verifies whether the procedure is complete by comparing measured impedance to the impedance threshold. If the measured impedance is greater than the impedance threshold, the tissue is sealed and the electrosurgical energy (e.g., RF power) is shut off and the algorithm proceeds to step 360 wherein the cooling timer is activated).
Regarding claim 17, Unger discloses that the control module is further configured to: in determination of ending the current sub- process, determine whether tissue closure operation has timed out ([0068]: If the tissue does not rise within the predetermined period of time (e.g., in step 320 the timer has expired) then, the generator 2 issues a regrasp alarm due to the tissue not responding); and proceed to the next sub-process when it is determined that the tissue closure operation is not timed out ([0067]: In step 316 the algorithm waits for a predetermined period of time to identify whether a rise in impedance has occurred, represented by phases IIIa and IIIb in FIG. 7. In step 318, the algorithm repeatedly attempts to identify a tissue reaction by determining if Z>ZLow+Z_Rise where Z(t) is the impedance at any time during sampling. In step 320, the algorithm verifies whether the timer for waiting for impedance to rise has expired; see loops of steps 316 > 318 > 320 > 316).
Regarding claim 18, Unger discloses that the control module is further configured to: in determination of ending the current sub- process, determine whether tissue closure operation has timed out ([0068]: If the tissue does not rise within the predetermined period of time (e.g., in step 320 the timer has expired) then, the generator 2 issues a regrasp alarm due to the tissue not responding); and
proceed to the next sub-process when it is determined that the tissue closure operation is not timed out ([0067]: In step 316 the algorithm waits for a predetermined period of time to identify whether a rise in impedance has occurred, represented by phases IIIa and IIIb in FIG. 7. In step 318, the algorithm repeatedly attempts to identify a tissue reaction by determining if Z>ZLow+Z_Rise where Z(t) is the impedance at any time during sampling. In step 320, the algorithm verifies whether the timer for waiting for impedance to rise has expired; see loops of steps 316 > 318 > 320 > 316).
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Unger as applied to claim 1 above, and further in view of Wham (U.S. Pub. No. 20150196344), herein referred to as “Wham”.
Regarding claim 12, Unger fails to disclose characterized in that the control module is further configured to:
calculate an effective voltage value and an effective current value of the output energy based on the sampling signals, and calculate a reference impedance of the tissue according to the effective voltage value and effective current value;
calculate a voltage peak value and a current peak value for a base frequency of the output energy, as well as a voltage peak value and a current peak value for the second harmonic based on the sampling signals using a discrete Fourier transform algorithm;
calculate a base frequency impedance according to the voltage peak value and current peak value of the base frequency, and calculate a second harmonic impedance according to the voltage peak value and current peak value of the second harmonic;
determine a weight coefficient of the base frequency impedance based on a ratio of the reference impedance to the base frequency impedance, and determine a weight coefficient of the second harmonic impedance based on a ratio of the reference impedance to the second harmonic impedance; and
weighted average the base frequency impedance and the second harmonic impedance based on the weight coefficient of the base frequency impedance and the weight coefficient of the second harmonic impedance, to obtain a real-time impedance of the tissue.
However, Wham discloses calculate an effective voltage value and an effective current value of the output energy based on the sampling signals ([0109]: In step 810, sensors sense voltage and current waveforms generated by an electrosurgical generator), and calculate a reference impedance of the tissue according to the effective voltage value and effective current value ([0100]: In step 850, the power dissipated in the tissue is calculated according to either equation (10) or (12) and the tissue impedance is calculated according to either equation (11) or (13));
calculate a voltage peak value and a current peak value for a base frequency of the output energy, as well as a voltage peak value and a current peak value for the second harmonic based on the sampling signals using a discrete Fourier transform algorithm ([0058]: The multiple frequency waveforms generated by the electrosurgical generator are analyzed by narrowband filters, e.g., Fourier transformation, Goertzel, or other frequency transform filters; [0109]: In step 820, a plurality of medium-band filters tuned to a respective plurality of groups of frequencies and a plurality of narrowband filters tuned to respective center frequencies in the respective plurality of groups of frequencies filter the sensed voltage and current waveforms. Each group of a plurality of frequencies includes a harmonic frequency and its sidebands; [0110]: In step 830, the RMS calculators 730a and 730b of FIG. 7 calculate medium-band RMS voltage and current values in quadrature according to equations (1) and (2) above);
calculate a base frequency impedance according to the voltage peak value and current peak value of the base frequency, and calculate a second harmonic impedance according to the voltage peak value and current peak value of the second harmonic ([0112]: Step 910 includes steps 810-840 of FIG. 8 for a plurality of frequencies; [0116] In step 960, the tissue impedance is calculated based on a single frequency. The single frequency may be selected based on the magnitude and frequency of the RF waveform. For example, the single frequency may be selected so as to achieve a high magnitude of the RF waveform at a low frequency. As another example, the single frequency may be selected so as to achieve a high magnitude of the RF waveform at a frequency other than a low frequency, such as a high frequency);
determine a weight coefficient of the base frequency impedance based on a ratio of the reference impedance to the base frequency impedance, and determine a weight coefficient of the second harmonic impedance based on a ratio of the reference impedance to the second harmonic impedance ([0026]: The weights may be percentages based on ratios between the medium-band RMS voltage values of a medium-band range of frequencies including a selected frequency and the total RMS voltage value, or ratios between the medium-band RMS current values of a medium-band range of frequencies including a selected a frequency and the total RMS current value; [0115]: step 950, a weight for the magnitude of each selected frequency is calculated. A weight can be a percentage value in quadrature or in straight percentage. A weighted RMS voltage is calculated by multiplying the weight by the corresponding total wideband RMS voltage and a weighted RMS current is calculated by multiplying a weight by the corresponding total wideband RMS current); and
weighted average the base frequency impedance and the second harmonic impedance based on the weight coefficient of the base frequency impedance and the weight coefficient of the second harmonic impedance, to obtain a real-time impedance of the tissue ([0116]: In step 960, the tissue impedance is calculated based on a single frequency).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the generator of Unger to include the processing module of Wham for the purpose of accurately determining the energy that is actually delivered to tissue (Wham: [0011]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Unger in view of Wham as applied to claim 12 above, and further in view of Falkenstein et al. (U.S. Pub. No. 20090248022), herein referred to as “Falkenstein”.
Regarding claim 13, Unger in view of Wham fail to disclose characterized in that the control module is further configured to:
calculate a reference phase of the output energy based on a voltage zero-crossing time point and a current zero-crossing time point in the sampling signals;
calculate a voltage phase and a current phase of the base frequency of the output energy, as well as a voltage phase and a current phase of the second harmonic of the output energy, using a discrete Fourier transform algorithm based on the sampling signals;
calculate a base frequency phase based on the voltage phase and current phase of the base frequency, and calculate a second harmonic phase based on the voltage phase and current phase of the second harmonic;
determine a weight coefficient of the base frequency phase based on a ratio of the reference phase to the base frequency phase, and determine a weight coefficient of the second harmonic phase based on a ratio of the reference phase to the second harmonic phase; and
weighted average the base frequency phase and the second harmonic phase based on the weight coefficient of the base frequency phase and the weight coefficient of the second harmonic phase, to obtain a real-time phase of the tissue.
However, Falkenstein discloses characterized in that the control module (electrosurgical unit 10, comprising feedback circuit 20 & controller 80) is further configured to:
calculate a reference phase of the output energy based on a voltage zero-crossing time point and a current zero-crossing time point in the sampling signals ([0200]: In one embodiment, phase measurement is a relative measurement between two sinusoidal signals. One signal is used as a reference, and the phase shift is measured relative to that reference. Since the signals are time varying, the measurement cannot be done instantaneously. The signals must be monitored long enough so that difference between them can be determined. Typically the time difference between two know points (sine wave cross through zero) are measured to determine the phase angle; [0207]: the output of a generator is fed into circuitry that determines the frequency of the driving signal and circuitry to measure the phase shift between voltage and current applied to the tissue);
calculate a voltage phase and a current phase of the base frequency of the output energy, as well as a voltage phase and a current phase of the second harmonic of the output energy, using a discrete Fourier transform algorithm based on the sampling signals ([0200]: The phase controller in one embodiment compares the input sine wave signal to a reference sine wave to determine the amount of phase shift; [0201]: The phase controller does this comparison using a mathematical process known as a Discreet Fourier Transform (DFT). In this particular case 1024 samples of the input signal are correlated point by point with both a sine function, and a cosine function; [0212]: In one embodiment, the phase shift is derived directly from the driving signal, i.e., the voltage and current supplied by the electrosurgical generator to the tissue. In one embodiment, an electrical circuit modifies the driving voltage having one (sinusoidal) frequency by superimposing a measurement signal at a vastly different frequency. As a result, electrical energy for the fusion process is provided at one frequency, while simultaneously applying as second signal at a second frequency for measurement);
calculate a base frequency phase based on the voltage phase and current phase of the base frequency, and calculate a second harmonic phase based on the voltage phase and current phase of the second harmonic ([0209]: The processed voltage (and current) signal containing the high voltage (and high current) signal at 300 to 500 kHz from the ESU, as well as low voltage (low current) signal at 5 MHz are sent through a multi-pole band pass filter centering at 5 MHz. The filter discriminates the signal from the ESU, leaving only the two signals at 5 MHz for measuring the phase shift in a phase comparator);
determine a weight coefficient of the base frequency phase based on a ratio of the reference phase to the base frequency phase, and determine a weight coefficient of the second harmonic phase based on a ratio of the reference phase to the second harmonic phase ([0258]: This is shown in FIG. 36 for the same seal as given in FIG. 35. As can be seen, the phase shift quickly increases during the initial fusion process, but then increases slowly for the remainder of the seal. The asymptotic approach can require a significant amount of time to reach the final phase threshold (e.g., 40 degrees). As such, instead of depending on the phase value to reach a definite value alone, additionally the derivate of the phase can be used to avoid asymptotic approaches to a finalized phase value. The derivative of the phase value of the same seal is shown in FIG. 37. As shown, the phase changes (increases) strongly during the first 0.5 s into the seal and changes little for the remainder of the seal. After about 1.5 s sealing time, the derivative of the phase d.phi./dt reaches a pre-determined value of 0.1 degrees/second to terminate the seal (independent of the actual phase reading)); and
weighted average the base frequency phase and the second harmonic phase based on the weight coefficient of the base frequency phase and the weight coefficient of the second harmonic phase, to obtain a real-time phase of the tissue ([0257]: As was shown previously, the fusion process of blood vessels and/or welding of tissue can be better controlled when the phase difference or angle between applied voltage and incurred current is measured and used to interrupt the fusion/sealing process; see Figs. 36-39).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the control module of Unger in view of Wham to include the control module of Falkenstein for the purpose of the relative change in phase difference is much larger at the end of the fusion process than the change in tissue resistance, allowing for easier and more precise measurement (Falkenstein: [0244]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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