DETAILED ACTION
This action is responsive to the amendment filed 2/17/26.
Claims 1-4, 6-16, 18-19 and 27-28 are finally rejected.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 4 and 16, applicant has amended the claims to include an RF power delivery profile which comprises both a ‘threshold impedance’ and a longer/shorter ‘RF power delivery time interval’. Applicant fails to disclose a single embodiment of the invention which utilizes both a ‘threshold impedance’ and fixed ‘RF power delivery time interval’ in the same RF energy profile. Indeed, these two variations seem to be at odds with each other since using an impedance threshold implies that the ‘RF power delivery interval’ would not be fixed prior to the application of energy. Therefore, claims 4 and 16 comprise new matter.
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 4, 12 and 16 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.
Regarding claims 4 and 16, applicant recites that the selected RF power delivery profile comprises selecting longer/shorter latter portions of the RF power delivery time interval in response to lower/higher measured changes in impedance. However, this limitation seems to contradict claim 1 which recites that the RF energy is imparted ‘while a measured impedance is less than the selected threshold impedance’. This use of an impedance threshold during energy delivery implies that the time interval of RF energy delivery is not fixed. Further, a review of the specification indicates that applicant contemplated using either an impedance threshold or fixed energy delivery time interval but not both as a means to limit the application of energy to the tissue.
Claim 12 recites the limitations ‘the RF delivery profile’ in lines 15 and 19, ‘the first RF power delivery time’ in lines 13 and 18, and ‘the first RF power delivery window’ in line 20. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-11, 13-16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asher et al. (US 20180333185, “Asher”) in view of Kennedy et al. (US 20110319882, “Kennedy”).
Regarding claim 1, Asher teaches an electrosurgical method performed by an electrosurgical device to seal biological tissue (Abstract, ‘method of sealing tissue […]’), the method comprising: imparting radio frequency (RF) power to biological tissue during an RF power delivery time interval (Fig. 12, step 612 and par. 71, ‘The clinician activates RF and ultrasonic energies on tissue in accordance with a step (612) at an initial time, To.’); measuring a change in impedance of the tissue with respect to RF energy delivered to the tissue sufficient to start sealing the biological tissue during an initial portion of the RF power delivery time interval (Fig. 12, steps 616: ‘Measure a First a Tissue RF Impedance at T1’; step 620: ‘Measure a First Tissue RF Impedance at T2’; step 624: ‘Calculate a Change in RF Impedance (dz) from T0 to T2’; further the RF power can be considered ‘sufficient to start sealing biological tissue’ since it is sufficient to change the impedance of the tissue which implies that the sealing process is being started; further, par. 82 discloses that the initial RF power can be 20W which is within the range of 1-50W disclosed by applicant for the initial RF power; see Specification, pg. 10, par. 2, lines 15-17); selecting an RF power delivery profile for a latter portion of the RF power delivery profile following the initial portion according to the measured change in impedance of the tissue with respect to RF energy delivered to the tissue during the initial portion (Fig. 12, dZ is used in step 626 to calculate dEtot/dZ which is used to determine the vessel size in step 630. The vessel size determination is the used to set one a low energy cap and intermediate energy cap or a large energy cap in steps 632/634/636 respectively; par. 79, ‘It will be further appreciated that in alternative embodiments, RF energy may also be similarly limited, such that the invention is not intended to be unnecessarily limited to only ultrasonic energy caps as shown in the present example.’); and imparting RF power to the tissue according to the selected RF power delivery profile during the latter portion of the RF power delivery time interval (Par. 74, ‘RF energy and the ultrasonic energy continues to be applied until reaching the set energy cap […]’; par. 79, ‘It will be further appreciated that in alternative embodiments, RF energy may also be similarly limited, such that the invention is not intended to be unnecessarily limited to only ultrasonic energy caps as shown in the present example.’).
Asher fails to teach that the step of selecting an RF delivery profile includes selecting a constant power level and selecting a threshold impedance according to the measured change in impedance of the tissue; that the imparting step includes imparting the RF power to tissue at the selected constant power level while a measured impedance is less than the selected threshold impedance during a latter portion of the RF power delivery time interval following the initial portion; and that the halting step includes halting delivery of the RF power when the measured impedance is greater than the selected threshold impedance during the latter portion.
The examiner notes, however, that Asher teaches various methods for interrogating the tissue to determine size of the tissue being sealed, as well as various methods for controlling application of energy to the tissue based on the determined tissue size in order to seal the tissue while inhibiting transection of the tissue. It is the examiner’s opinion that it would have been obvious to POSITA to mix and match the various disclosed methods for determining tissue size with the various methods for controlling the application of energy in response to the determined tissue size since these steps are interchangeable with each other. Par. 30 of Asher similarly emphasizes that the drawings ‘are not intended to be limiting’ and that they along with description are meant ‘to explain the principles of the invention’ and that the ‘invention is not limited to the precise arrangement shown’.
Therefore, fig. 11 of Asher, teaches an alternative protocol for selecting/imparting an RF delivery profile based on the determined tissue size which comprises selecting an RF power delivery profile for a latter portion of the RF power delivery profile following the initial portion (Fig. 11, the initial portion of RF power delivery can be considered the RF power delivery in step 512 used in the determination of vessel size, whereas the latter portion of RF power delivery can be the RF power delivery in steps 526/540 which is used to seal the tissue) that includes selecting a power level (Fig. 11, steps 520/522: set a high power cap) and a threshold impedance according to the measured tissue size (Fig. 11, steps 534/548, the low/high ‘termination impedances’ can be mapped to the recited ‘threshold impedance’); imparting the RF power to tissue at the selected power level (Fig. 11, steps 526/540: activate RF energy according to predetermined parameters) while a measured impedance is less than the selected threshold impedance during a latter portion of the RF power delivery time interval following the initial portion (Fig. 11, steps 534/548: is the measured tissue impedance meeting or exceeding a low/high termination impedance?); and that the halting step includes halting delivery of the RF power when the measured impedance is greater than the selected threshold impedance during the latter portion (Fig. 11, steps 538/552: terminate RF and ultrasonic energy).
Therefore, since figs. 11 and 12 of Asher teach different methods of controlling RF energy to seal tissue which is optimized for a measured tissue size, it would have been obvious to POSITA at the time that the invention was filed to substitute one known method for controlling the application of RF energy to seal tissue (i.e., the method disclosed in fig. 11) for the other (i.e. the method disclosed in fig. 12) in order to arrive at the predictable result of a method for controlling RF energy to seal tissue which optimized for a measured tissue size. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Asher, as modified, however, still fails to teach that selecting a power level comprises selecting a constant power level.
However, Kennedy teaches an analogous device and method for sealing tissue (Abstract, ‘A surgical system and associated method for sealing the passageway of a fluid-carrying vessel with a diameter up to 5 millimeters’) which comprises an RF generator (Par. 30, ‘RF generator’) configured to impart a constant RF power (Abstract, ‘Radio frequency energy is applied to the vessel for a period of time while the power is held approximately constant.’; par. 8, ‘In a further embodiment, an electrosurgical vessel sealing system can produce controlled RF vessel sealing with between 7 Watts and 15 Watts of constant power applied with an upper limit of 75 volts and a range of between 0.8 and 1.2 amps.’).
Therefore, since both Asher and Kennedy teach different RF power profiles for sealing tissue, it would have been obvious to POSITA at the time that the invention was filed to substitute one known power profile for sealing tissue (i.e., the constant power profiled disclosed by Kennedy) for the other (i.e., the unspecified power profiled disclosed by Asher) in order to arrive at the predicable result of a power profile for sealing tissue. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting an RF power delivery profile to deliver a first RF power level in the latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion (Asher has previously been modified to combine the protocol for determining tissue size disclosed by fig.12 with the protocol for selecting/imparting RF energy in response to the determination of tissue size disclosed by fig. 11; this method step can be mapped to step 520 of fig. 11, which sets an RF power cap for medium sized tissue. Further based on the normalized change of energy chart shown in fig. 14, one can deduce that when using the protocol for determining tissue size disclosed in fig. 12, that medium sized tissue has a lower measured change in impedance relative to the large and small sized tissues, since dZ is in the denominator of dETot/dZ which implies a lower dZ for a higher value for dETot/dZ. Fig. 14, shows that dETot/dZ is higher for medium sized tissue than it is for large and small sized tissue which implies that dZ is smaller for a medium sized tissue than it is for small and large sized tissues); and selecting an RF power delivery profile to deliver a second RF power level in the latter part of the RF power delivery time interval in response to higher measured change in impedance during the initial portion (This method step can be mapped to steps 520/522 of fig. 11, which set an RF power cap for small and large sized tissues respectively. Further, based on the normalized change of energy chart shown in fig. 14, one can deduce that when using the protocol for determining tissue size disclosed in fig. 12, that small and large sized tissues have higher measured changes in impedance relative to medium sized tissue, since dZ is in the denominator of dETot/dZ which implies a higher dZ for lower values for dETot/dZ. Fig. 14, shows that dETot/dZ is lower for small and large sized tissues than it is for medium sized tissue implying that that dZ is higher for these tissue sizes relative to medium sized tissue). Asher, as modified, fails to teach wherein the first RF power level is greater than the second amount of energy (interpreted as the ‘second RF power level’).
The examiner maintains, however, that it would have been obvious to POSITA to select an appropriate power level as needed based on the determination of tissue size. For instance, Asher explicitly recognizes the power level of the applied RF energy to be a result effective variable which affects the ability of the device to seal the tissue while avoiding the unwanted transection of tissue (Abstract, ‘An ultrasonic surgical instrument and method of sealing tissue includes interrogating the tissue with an electrical signal and adjusting an electrical parameter of at least one of the ultrasonic energy or the RF energy in response to the tissue feedback to inhibit transecting the tissue’; par. 69, ‘The particular high power cap may thus be configured based on the tissue size determination’). Therefore, it would have been obvious to POSITA to optimize the selection of power level based on the determined tissue size (which is determined based on a measured change of impedance) such that the first RF power level is greater than the second RF power level, in order to optimize the energy delivery to the tissue to provide sealing while inhibiting tissue transection, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 3, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting a higher constant power level during the latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion; and selecting a lower constant power level during the latter portion of the RF power delivery time interval in response to a higher measured change in impedance during the initial portion (Asher has previously been modified to optimize the selected power level as claimed; see the discussion of claim 2, above).
Regarding claim 4, Asher, as modified, fails to teach wherein selecting the RF power delivery profile includes, using a longer latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion; and using shorter latter portion of the RF power delivery time interval in response to a higher measured change in impedance during the initial portion.
Kennedy, however, teaches an analogous protocol for halting the delivery of energy during a tissue sealing operation wherein the energy is halted both if the measured tissue impedance reaches a final value and/or if the maximum seal time exceeds predetermined treatment time (Par. 37, ‘The power delivery cycle may terminate when one or more of the following occurs: a) voltage reaches a maximum level not to exceed a set level such as 80 Volts RMS or 100 Volts RMS; b) impedance reaches a final value of between 180-350 ohms; and c) a maximum seal time of between 2 and 5 seconds is reached. In addition, voltage or current limits may be put in place that further confine the operational parameters of the power delivery system.’).
Therefore, in view of Kennedy it would have been obvious to POSITA at the time that the invention was filed to further modify, Asher, as modified, by providing for the selection of a maximum seal time in addition to the impedance threshold, in order to provide an additional fail-safe against over-treatment of the tissue, as taught by Kennedy.
Asher, as modified, however, still fails to teach that the time interval is longer for lower change in impedance tissues and shorter for high higher change in impedance tissues.
The examiner maintains, however, that POSITA would have considered the maximum duration of energy application to be a result effective variable that directly affects the maximum energy dosage supplied to the tissue, and thus the ability of the device to properly seal tissues of different sizes. For instance, Kennedy already discloses that larger tissue will take longer to seal at given RF power settings (Par. 99, ‘Seal time was determined by observing when the power was triggered to switch off. FIG. 11 shows the results for a 3.5 mm Vessel with a 1.5 second seal time. FIG. 12 shows the results for a 5 mm vessel with a 2.3 second seal time. FIG. 13 shows the results for a 1.5 mm Vessel with a 0.75 second seal time.’). Therefore, it would have been obvious to POSITA to optimize the maximum seal times based on different tissue sizes, for instance supplying a relatively longer maximum seal time for medium sized vessels which have a lower impedance change versus smaller sized vessels which have a higher impedance change, in order to optimize the maximum amount of energy that can be delivered for a given tissue size, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 6, Asher, as modified, teaches providing higher impedance thresholds optimized for a larger tissue sizes (Fig. 11, steps 534/548: low/high termination impedances), but fails to teach wherein selecting the RF power delivery profile includes, selecting a higher threshold impedance value in response to a lower measured change in impedance during the initial portion, and selecting a lower threshold impedance value in response to a higher measured change in impedance during the initial portion.
The examiner maintains, however, that POSITA would have considered the impedance threshold value to be a result effective variable that directly affects the efficacy of the sealing operation. Therefore, upon selecting an impedance threshold for determining the endpoint of the sealing operation it would have been obvious to POSITA to optimize the impedance threshold to match the measured tissue size, for instance supplying a relatively high impedance threshold for medium sized vessels which have a lower impedance change versus smaller sized vessels which have a higher impedance change, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 7, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting a higher threshold impedance value and a higher constant power level during the latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion; and selecting a lower threshold impedance value and a lower constant power level during the latter portion of the RF power delivery time interval in response to a higher measured change in impedance during the initial portion (Both the impedance threshold and constant power level have previously been modified to match the different tissues sizes which are determined through a change in impedance measurement; see the discussion of claims 2, 3 and 6, above).
Regarding claim 8, Asher further teaches wherein measuring a change in impedance of the tissue with respect to RF energy delivered to the tissue during an initial portion of the RF power delivery time interval includes totalizing power during the initial portion (Fig. 12, step 626: ‘Calculate a Normalized Change in Energy (dETot/dZ)’).
Regarding claim 9, Asher, as modified, further teaches wherein imparting RF power to biological tissue during the RF power delivery time interval include delivering a predetermined RF power during the initial portion (Fig. 12, step 612: ‘Activate Ultrasonic Energy and RF Energy at T0’; par. 61, ‘The clinician actives ultrasonic and RF energies respectively at an initial ultrasonic power with a constant ultrasonic drive current and an initial constant RF power on tissue at an initial time, T0’).
Regarding claim 11, Asher, as modified, further teaches wherein measuring change in impedance of the tissue includes measuring phase angle between RF voltage across the tissue to RF current through the tissue (Par. 61, ‘Controller (46) then measures RF impedance, specifically a complex RF impedance, with a relatively low frequency RF interrogation signal, such as 1000 Hz, in a step (414). Notably, with respect to FIG. 9, relatively low frequency RF interrogation signals provide for measurements of complex RF impedance with a magnitude and a greater phase angle differential between large and small tissues than intermediate and high frequency RF interrogations signals, such as 2,000 Hz and 35,000 Hz, respectively.’).
Regarding claim 13, Asher, as modified, teaches an electrosurgical system for sealing biological tissue (Abstract, ‘method of sealing tissue […]’), comprising: an RF output stage configured to impart an RF power to the tissue (Fig. 12, step 612 and par. 71, ‘The clinician activates RF and ultrasonic energies on tissue in accordance with a step (612) at an initial time, To.’); a processor circuit (Par. 37, ‘For example, in operation, the clinician may program or otherwise control operation of generator (32) using input device (32) (e.g., by one or more processors contained in the generator) to control the operation of generator (14)’); a memory storing instructions that, when executed by the processor, cause the processor to perform operations including (Par. 37, a programmable processor inherently comprises a memory): causing the RF output stage to impart RF power to the tissue during an RF power delivery time interval (Fig. 12, step 612 and par. 71, ‘The clinician activates RF and ultrasonic energies on tissue in accordance with a step (612) at an initial time, To.’); determining a change in impedance of the tissue during an initial portion of the RF power delivery time interval (Fig. 12, steps 616: ‘Measure a First a Tissue RF Impedance at T1’; step 620: ‘Measure a First a Tissue RF Impedance at T2’; step 624: ‘Calculate a Change in RF Impedance (dz) from T0 to T2’), wherein the RF power imparted during the initial portion is sufficient to start sealing the biological tissue (Fig. 12, step 624: ‘Calculate a Change in RF Impedance (dz) from T0 to T2’; the RF power can be considered ‘sufficient to start sealing biological tissue’ since it is sufficient to change the impedance of the tissue which implies that the sealing process is being started; further, par. 82 discloses that the initial RF power can be 20W which is within the range of 1-50W disclosed by applicant for the initial RF power; see Specification, pg. 10, par. 2, lines 15-17); selecting an RF power delivery profile to deliver a latter portion of the RF delivery time interval following the initial portion of the RF delivery time interval (Asher has previously been modified to combine the protocol for determining tissue size disclosed by fig.12 with the protocol for selecting/imparting RF energy in response to the determination of tissue size disclosed by fig. 11; fig. 11, steps 520/522: set a high power cap) that includes a selected constant power level (Asher has previously been modified in view of Kennedy to provide constant power during sealing; see Kennedy, Abstract, ‘Radio frequency energy is applied to the vessel for a period of time while the power is held approximately constant.’; par. 8, ‘In a further embodiment, an electrosurgical vessel sealing system can produce controlled RF vessel sealing with between 7 Watts and 15 Watts of constant power applied with an upper limit of 75 volts and a range of between 0.8 and 1.2 amps.’) and a selected threshold impedance according to the measured change in impedance of the tissue (Asher has previously been modified to combine the protocol for determining tissue size disclosed by fig.12 with the protocol for selecting/imparting RF energy in response to the determination of tissue size disclosed by fig. 11; fig. 11, steps 534/548, the low/high ‘termination impedances’ can be mapped to the recited ‘threshold impedance’); and causing the RF output stage to impart RF power to the tissue (Fig. 11, steps 526/540: activate RF energy according to predetermined parameters) at the selected constant power level (See Kennedy, Abstract, ‘[…] power is held approximately constant’) while a determined impedance is less than the selected threshold impedance during a latter portion of the RF power delivery time interval (Fig. 11, steps 534/548: is the measured tissue impedance meeting or exceeding a low/high termination impedance?); and halting delivery of the RF power when the measured impedance is greater than the selected threshold impedance during the latter portion (Fig. 11, steps 538/552: terminate RF and ultrasonic energy).
Asher, as modified, fails to teach current measurement circuitry configured to measure RF current within the tissue during the imparting of the RF power to the tissue; voltage measurement circuitry configured to measure of RF voltage across the tissue during the imparting of the RF power to the tissue; and that the determining of a change in impedance is based upon current measured by the current measurement circuit and voltage measured by the voltage measurement circuit
Kennedy, however, further teaches a current measurement circuitry configured to measure RF current within the tissue during the imparting of the RF power to the tissue (Fig. 7 and par. 58, ‘Coupled to the load 400 (e.g. an electrosurgical instrument) are a current sensor circuit 390 and a voltage sensor circuit 395.’); a voltage measurement circuitry configured to measure of RF voltage across the tissue during the imparting of the RF power to the tissue (Fig. 7 and par. 58, ‘Coupled to the load 400 (e.g. an electrosurgical instrument) are a current sensor circuit 390 and a voltage sensor circuit 395.’); and a controller (Fig. 7, controller 360) which is configured to calculate tissue impedance based upon current measured by the current measurement circuit and voltage measured by the voltage measurement circuit (Fig. 7 and par. 58, ‘A multiplier 386 and a divider 388 derive power and impedance respectively from the sensed voltage and current.’).
Therefore, since both Asher and Kennedy teach different methods for calculating tissue impedance during a tissue sealing operation, it would have been obvious to POSITA at the time that the invention was filed to further modify Asher, as modified, by substituting one known method for calculating tissue impedance for the other in order to arrive at the predictable result of a method for calculating tissue impedance during a tissue sealing operation. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 10, Asher, as modified, further teaches wherein measuring a change in impedance of the tissue with respect to RF energy delivered to the tissue during an initial portion of the RF power delivery time interval includes measuring RF voltage across the tissue and measuring RF current through the tissue (Asher has previously been modified in view of Kennedy to derive impedance from current and voltage measurements; see Kennedy, fig. 7 and par. 58, ‘A multiplier 386 and a divider 388 derive power and impedance respectively from the sensed voltage and current.’).
Regarding claim 14, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting an RF power delivery profile to deliver a first RF power level in the latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion (Asher has previously been modified to combine the protocol for determining tissue size disclosed by fig.12 with the protocol for selecting/imparting RF energy in response to the determination of tissue size disclosed by fig. 11; this method step can be mapped to step 520 of fig. 11, which sets an RF power cap for medium sized tissue. Further based on the normalized change of energy chart shown in fig. 14, one can deduce that when using the protocol for determining tissue size disclosed in fig. 12, that medium sized tissue has a lower measured change in impedance relative to the large and small sized tissues, since dZ is in the denominator of dETot/dZ which implies a lower dZ for a higher value for dETot/dZ. Fig. 14, shows that dETot/dZ is higher for medium sized tissue than it is for large and small sized tissues which implies that dZ is smaller for a medium sized tissue than it is for small and large sized tissues); and selecting an RF power delivery profile to deliver a second RF power level in the latter part of the RF power delivery time interval in response to higher measured change in impedance during the initial portion (This method step can be mapped to steps 520/522 of fig. 11, which set an RF power cap for small and large sized tissues respectively. Further, based on the normalized change of energy chart shown in fig. 14, one can deduce that when using the protocol for determining tissue size disclosed in fig. 12, that small and large sized tissues have higher measured changes in impedance relative to medium sized tissue, since dZ is in the denominator of dETot/dZ which implies a higher dZ for lower values for dETot/dZ. Fig. 14, shows that dETot/dZ is lower for small and large sized tissues than it is for medium sized tissue implying that that dZ is higher for these tissue sizes relative to medium sized tissue); wherein the first RF power level is greater than the second RF power level (Asher has previously been modified to optimize the selected power level as claimed; see the discussion of claim 2, above).
Regarding claim 15, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting a higher constant power level during the latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion; and selecting a lower constant power level during the latter portion of the RF power delivery time interval in response to a higher measured change in impedance during the initial portion (Asher has previously been modified to optimize the power level during the latter portion of RF power delivery; see the discussion of claims 2-3, above).
Regarding claim 16, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting a longer latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion; and selecting a shorter latter portion of the RF power delivery time interval in response to a higher measured change in impedance during the initial portion (Asher has previously been modified in view of Kennedy to include a maximum seal time within the RF profile; further, the duration of this maximum seal time has previously been optimized; see the discussion of claim 4, above).
Regarding claim 18, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting a higher threshold impedance value in response to a lower measured change in impedance during the initial portion; and selecting a lower threshold impedance value in response to a higher measured change in impedance during the initial portion (Asher has previously been modified to optimize the impedance threshold value; see the discussion of claim 6, above).
Regarding claim 19, Asher, as modified, further teaches wherein selecting the RF power delivery profile includes, selecting a higher threshold impedance value and a higher constant power level during the latter portion of the RF power delivery time interval in response to a lower measured change in impedance during the initial portion; and selecting a lower threshold impedance value and a lower constant power level during the latter portion of the RF power delivery time interval in response to a higher measured change in impedance during the initial portion (Both the impedance threshold and constant power level have previously been optimized to match the different tissues sizes which are determined through a change in impedance measurement; see the discussion of claims 2-3 and 6, above).
Regarding claim 27, Asher, as modified, further teaches wherein the measuring the change in impedance of the tissue with respect to RF energy delivered to the tissue includes: determining a totalized power delivered to the tissue during an initial portion of the RF power delivery time interval (Fig. 12, step 626: ‘Calculate a Normalized Change in Energy (dETot/dZ)’; dETot can be considered the totalized power); and determining a ratio of the change in impedance of the tissue divided by the totalized power during the initial portion of the RF power delivery time interval (Fig. 12, step 626: ‘Calculate a Normalized Change in Energy (dETot/dZ)’; dETot/dZ is merely the inverse of the claimed ratio).
Regarding claim 28, Asher, as modified, further teaches including a mechanical blade to transect the biological tissue after the biological tissue is sealed (Par. 4, “The end effector of an electrosurgical device may also include a cutting member that is movable relative to the tissue and the electrodes to transect the tissue.”).
Response to Arguments
Applicant's arguments filed 2/17/26 have been fully considered but they are not persuasive.
Regarding the rejections of claims 4 and 16 under 35 U.S.C. 112, the examiner disagrees that figs. 6B and 7B show that a lower rate of change in impedance results in a longer duration of the latter portion, as alleged by applicant.
Regarding the rejection of claim 12 under 35 U.S.C. 112(b), the examiner contends that applicant has not fully addressed the lack of antecedent basis for various claim terms.
Finally, regarding the prior art rejections of claims 1 and 13, the examiner disagrees that Asher cannot be used to teach an RF power delivery during the initial portion ‘sufficient to start sealing tissue’. For instance, Asher delivers an RF power during the initial portion sufficient to change the impedance of the tissue. Change in impedance of tissue is used as a measure of sealing efficacy in Asher. Therefore, since tissue impedance is already changing during the initial portion, the sealing process can be considered ‘started’. Further, the examiner notes that Asher’s disclosed initial power of 20W (Pars. 82) is commensurate with applicant’s disclosed range of 1-50W (See Specification, pg. 10, par. 2, lines 15-17).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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