DETAILED ACTION
This action is pursuant to claims filed on 6/30/2026. Claims 1, 3-8, 10, and 12-20 are pending. A final action on the merits of claims 1-8, 10, and 12-20 is as follows.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-5, 7-8, 10, 11-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (hereinafter ‘Shah’, US 20220000539 A1) in view of Tanaka et al. (hereinafter ‘Tanaka’, US 20110077630 A1) and in further view of Podhajsky (US 20120016359 A1).
Regarding claim 1, Shah discloses an electrosurgical system (electrosurgical system shown in Figs. 1 and 2), comprising:
a vessel sealer having a pair of jaws ([0012]: Fig. 2 is a side view of a portion of an example electrosurgical instrument end effector that includes a pair of opposed jaws) and
an electrosurgical generator (generator system 100 in Fig. 1) coupled to the pair of jaws of the vessel sealer ([0025]: the high frequency output energy can be applied across first and second output terminals at a surgical instrument end effector; [0026]: output terminals 108, 110 may be disposed at a surgical instrument end effector 128 to contact two different locations on biological tissue) and having a controller (processor 122 in Fig. 1; also referred to as microcontroller 122 at the end of [0037]) configured to output radiofrequency energy to the pair of jaws of the vessel sealer ([0041]-[0042]: the processor 122 executes instructions stored in memory 123 to cause the processor to provide control signals to the DC regulator 104 to cause the RF output stage 106 to impart RF energy to tissue electrically coupled between the electrodes 108, 110);
wherein the controller is configured to output an amount of radiofrequency energy ([0058]: the processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to generate a first voltage signal sufficient to deliver a first power level) in a first stage (T1 in Fig. 7A) at a first power level (50W power level of T1 in Fig. 7A) until a first stopping point (stopping point is the vertical line at the beginning of Twait in Fig. 7A), and during impedance of the tissue will decrease between a beginning of the first stage and an end of the first stage (as seen in Fig. 9; [0062]: 0 seconds to 1 second is the Tinitial to determine if the tissue is high-impedance type – this is the same as the T1 in Fig. 7A; as seen in both Figs. 7A and 9, there is an initial impedance drop at the beginning of the energy application – the claim does not limit whether or not the impedance can drop and then subsequently rise in the same phase)
to interrupt the output of radiofrequency ([0058]: the processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to halt delivery of RF power in response to the tissue impedance reaching a predetermined impedance threshold) energy in a second stage (T-wait in Fig. 7A) for a period of time ([0058]: the processor 122 then waits for a Twait time) to allow for rehydration of any tissue trapped in the pair of jaws (this is a property of the tissue because sealing is not complete so the tissue maintains some degree of blood flow through or near the site which provides a degree of tissue rehydration; [0058]: the time delay rests the tissue between voltage signals to avoid unwanted tissue damage), wherein the period of time is one of a fixed duration ([0058]: the processor waits for a Twait time – this time is fixed for the operation and Shah is silent to the time varying) and a variable duration depending at least in part on the impedance of the tissue, and
to output radiofrequency energy ([0058]: the processor 122 then executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to generate a second voltage signal sufficient during a second time window T2, to deliver a power level, such as 50W for example, to the tissue) in third stage (T2 in Fig. 7A) at a second power level (50W power level of T2 in Fig. 7A) and that will cause any tissue trapped in the pair of jaws to be heated above the polymerization temperature of the tissue to cause sealing of the tissue ([0058]: the delivery of two consecutive RF power leads to a better seal on higher impedance tissue; [0006]: during tissue sealing, RF current density between electrodes is selected to achieve a rate of tissue heating to result in sealing, which as used herein refers to tissue dehydration, vessel wall shrinkage and coagulation of blood constituents and collagen denaturization and bonding – thus the heating in the second cycle heats the tissue to a degree that causes polymerization of the tissue for sealing – this is a part of utilizing RF energy for tissue sealing as the RF energy heats the tissue such that it polymerizes and seals).
However, Shah is silent to the effect on the tissue during the first phase.
Tanaka teaches a treatment method for sealing tissue that uses a phased method to achieve tissue sealing ([Abstract]). Tanaka further teaches utilizing a first preheating phase before a higher power HF energy output period (Fig. 15C). The preheating phase is preferably between 40°C and 80°C, and once the desired temperature is reached, the preheating is stopped ([0201]). As stated in the instant application, polymerization of the proteins typically begins between 70-80°C and that the moisture in the tissue evaporates at 100°C (instant application [0016]). Tanaka therefore teaches the preheating stage stopping before full polymerization occurs. Tanaka further teaches that preheating the tissue allows for the prevention of non-uniform thermal spread ([0204]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the process of Shah with that of Tanaka so that during the first phase, the tissue is preheated to a temperature below the polymerization temperature of the tissue such that full polymerization does not occur to protect against non-uniform thermal spread during the application of the sealing phase.
However, the Shah/Tanaka combination is silent to the period of time to allow for rehydration depending upon the impedance of the tissue. Additionally, while the wait time in Shaw allows for a degree of rehydration, Shah does not specifically state that the tissue is rehydrated during this pause.
Shah states that the processor waits for a Twait time to prevent unwanted tissue damage ([0058]).
Podhajsky teaches a method for performing electrosurgical procedures by monitoring the minima and/or the maxima of the impedance readings with the hydration level of the tissue ([Abstract]). Applying energy in pulses allows the tissue to cool down and rehydrate between pulses which enhances the sealing process ([0008]). Allowing the tissue to hydrate affects the heat transfer available through the local water content of the tissue to prevent overdessication ([0012]). The controller or the hydration analyzer perform analysis of the tissue to identify the maxima and minima of the tissue conductivity/impedance data that correlate to hydration level and direction of water motility ([0052]). Podhajsky further teaches that the power supply can be adapted as a function of the maxima and minima of the tissue conductivity/impedance that specifically relates to the hydration level of the tissue ([0054]). The energy supply is controlled such that the impedance of the tissue, which shows the hydration levels, hits desired values based on the types of tissue ([0061]). These desired values are the thresholds that the impedance must hit based on the stage of energy application. During the stop phase, the osmotic pressure draws water into the tissue, decreasing the impedance. Energy is then reapplied once the minimum impedance is achieved and the temperature of the tissue is subsequently increased ([0101]). Sensing, monitoring and controlling hydration around the energy device ensures that the energy device is ultimately controlled so that energy is delivered to the tissue in the most efficient manner and that the duration of the procedure is the minimum time necessary to achieve the desired tissue effect ([0099]). It would be of routine skill in the art to modify the Shah/Tanaka combination such that the impedance, which is indicative of the tissue hydration level, is monitored during the pause between cycles. Shah already teaches that the pause is to prevent unwanted tissue damage and Podhajsky teaches that a pause to allow for rehydration prevents overdessication. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Shah/Tanaka combination with the teachings of Podhajsky such that during the pause in Shaw, tissue rehydrates and the hydration level of the tissue is monitored via the impedance during the Twait time period to ensure that the power is only applied once a minimum impedance has been reached to indicate sufficient tissue rehydration, thus preventing adverse tissue effects.
However, the Shah/Tanaka/Podhajsky combination is silent to the second power level being higher than the first power level.
Shah discloses an alternate embodiment in which a first power level of 50W is delivered in a first stage and a second power level of 55W is delivered in a second stage. The delivery of the higher power in the second stage reduces the overall time required to seal a higher impedance tissue ([0060]). Shah further discloses that modification of the method to control the RF delivery to seal biological tissue based on the principles defined in the disclosure is within the scope of the invention ([0093]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Fig. 7A such that the second power level is increased to 55W, which is higher than the first power level, to reduce the overall time required to seal high impedance tissues.
Regarding claim 3, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 2, wherein the first stopping point is selected from the group consisting of the time at which the tissue achieves a minimum impedance for a minimum amount of time, the time at which the tissue reaches a predetermined impedance measured after a fixed amount of time, the time at which a fixed amount of time has passed, and the time at which a rate of change of impedance of the tissue exceeds a threshold (Shah [0058]: The processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to halt delivery of RF power in response to the tissue impedance reaching a predetermined impedance threshold for a higher impedance tissue – this meets the claim language of achieving a minimum impedance for a minimum amount of time because the minimum impedance is the impedance threshold and the minimum amount of time is the time that it hits the threshold).
Regarding claim 4, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 3, wherein the period of time of the second stage comprises the fixed duration ([0058]: the processor waits for a Twait time – this time is fixed for the operation and Shah is silent to the time varying).
Regarding claim 5, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 3 as described above, wherein the period of the second stage comprises the variable duration (Podhajsky [0101]: energy is then reapplied once the minimum impedance is achieved – thus the stopping period can be based on the time to reach a minimum impedance which is inherently not constant across different tissue types).
Regarding claim 7, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 3, wherein the third stage comprises the output of power at the second power level until the tissue reaches an end point (the power level of the T---2 time stays at 55W during the entire duration of T2 as seen in Fig. 7A and described in the combination above).
Regarding claim 8, the Shah/Tanaka/Podhajsky combination discloses the invention substantially in claim 1 and described above. Additionally, the Shah/Tanaka combination discloses that the second power level may not switch to a third power level (the power level stays constant and does not switch level as seen in Fig. 7A).
However, the combination is silent to the third stage switching to a third power level.
Shah teaches in another embodiment that during an initial time window of a sealing phase, the tissue is sensed to determine whether it is a high impedance type ([0060]). The term ‘higher impedance tissue type’ as used herein refers to impedance starting at higher than 200 ohms or not falling below 100 ohms within Tinit window ([0057]). In response to determination during the initial time window that the tissue has a higher impedance type, the processor 122, during a latter portion of a power delivery time interval, causes the RF output stage 106 to generate a voltage sufficient to deliver a second higher power level ([0060]). The delivery of a higher is RF power level during the latter part of the tissue scaling stage reduces the overall time required to seal a higher impedance tissue ([0060]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiment of Fig. 7A of Shah with the embodiment of Fig. 7C such that during the second time window of Fig. 7A the power can be adjusted from a lower power level to a higher power level based on the tissue impedance to reduce the time required to seal the tissue.
Regarding independent claim 10, Shah discloses a method of controlling an amount of power output from an electrosurgical generator to a vessel sealer having a pair of jaws, comprising:
providing a vessel sealer having a pair of jaws ([0012]: Fig. 2 is a side view of a portion of an example electrosurgical instrument end effector that includes a pair of opposed jaws – the electrosurgical vessel sealer is provided);
coupling the electrosurgical generator to the pair of jaws of the vessel sealer ([0026]: In operation, the first and second output terminals 108, 110 may be disposed at a surgical instrument end effector 128 to contact two different locations on biological tissue 120; as seen in Fig. 1, the output terminals couple to the generator system); and
powering the electrosurgical generator to output radiofrequency energy to the vessel sealer [0058]: the processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to generate a first voltage signal sufficient to deliver a first power level) in a first stage (T1 in Fig. 7A) at a first power level (50W power level of T1 in Fig. 7A ) until a first stopping point (stopping point is the vertical line at the beginning of Twait in Fig. 7A) and an impedance of the tissue will decrease between a beginning of the first stage and an end of the first stage (as seen in Fig. 9; [0062]: 0 seconds to 1 second is the Tinitial to determine if the tissue is high-impedance type – this is the same as the T1 in Fig. 7A; as seen in both Figs. 7A and 9, there is an initial impedance drop at the beginning of the energy application – the claim does not limit whether or not the impedance can drop and then subsequently rise in the same phase), to interrupt the output of radiofrequency energy ([0058]: the processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to halt delivery of RF power in response to the tissue impedance reaching a predetermined impedance threshold) in a second stage (T-wait in Fig. 7A) for a period of time ([0058]: the processor 122 then waits for a Twait time) to allow for rehydration of any tissue trapped in the pair of jaws (this is inherent property of the tissue because sealing is not complete so the tissue maintains some degree of blood flow for rehydration; [0058]: the time delay rests the tissue between voltage signals to avoid unwanted tissue damage) that is one of a fixed duration and a variable duration dependent at least in part on the impedance of the tissue ([0058]: the processor waits for a Twait time – this time is fixed for the operation and Shah is silent to the time varying), and to output radiofrequency energy ([0058]: the processor 122 then executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to generate a second voltage signal sufficient during a second time window T2, to deliver a power level, such as 50W for example, to the tissue) in a third stage (T2 in Fig. 7A) at a second power level (50W power level of T2 in Fig. 7A) to cause sealing of any tissue trapped within the pair of jaws ([0058]: the delivery of two consecutive RF power leads to a better seal on higher impedance tissue).
However, Shah is silent to the effect on the tissue during the first phase.
Tanaka teaches a treatment method for sealing tissue that uses a phased method to achieve tissue sealing ([Abstract]). Tanaka further teaches utilizing a first preheating phase before a higher power HF energy output period (Fig. 15C). The preheating phase is preferably between 40°C and 80°C, and once the desired temperature is reached, the preheating is stopped ([0201]). As stated in the instant application, polymerization of the proteins typically begins between 70-80°C and that the moisture in the tissue evaporates at 100°C (instant application [0016]). Tanaka therefore teaches the preheating stage stopping before full polymerization occurs. Tanaka further teaches that preheating the tissue allows for the prevention of non-uniform thermal spread ([0204]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the process of Shah with that of Tanaka so that during the first phase, the tissue is preheated to a temperature below the polymerization temperature of the tissue such that full polymerization does not occur to protect against non-uniform thermal spread during the application of the sealing phase.
However, the Shah/Tanaka combination is silent to the period of time to allow for rehydration depending upon the impedance of the tissue. Additionally, while the wait time in Shaw allows for a degree of rehydration, Shah does not specifically state that the tissue is rehydrated during this pause.
Shah states that the processor waits for a Twait time to prevent unwanted tissue damage ([0058]).
Podhajsky teaches a method for performing electrosurgical procedures by monitoring the minima and/or the maxima of the impedance readings with the hydration level of the tissue ([Abstract]). Applying energy in pulses allows the tissue to cool down and rehydrate between pulses which enhances the sealing process ([0008]). Allowing the tissue to hydrate affects the heat transfer available through the local water content of the tissue to prevent overdessication ([0012]). The controller or the hydration analyzer perform analysis of the tissue to identify the maxima and minima of the tissue conductivity/impedance data that correlate to hydration level and direction of water motility ([0052]). Podhajsky further teaches that the power supply can be adapted as a function of the maxima and minima of the tissue conductivity/impedance that specifically relates to the hydration level of the tissue ([0054]). The energy supply is controlled such that the impedance of the tissue, which shows the hydration levels, hits desired values based on the types of tissue ([0061]). These desired values are the thresholds that the impedance must hit based on the stage of energy application. During the stop phase, the osmotic pressure draws water into the tissue, decreasing the impedance. Energy is then reapplied once the minimum impedance is achieved and the temperature of the tissue is subsequently increased ([0101]). Sensing, monitoring and controlling hydration around the energy device ensures that the energy device is ultimately controlled so that energy is delivered to the tissue in the most efficient manner and that the duration of the procedure is the minimum time necessary to achieve the desired tissue effect ([0099]). It would be of routine skill in the art to modify the Shah/Tanaka combination such that the impedance, which is indicative of the tissue hydration level, is monitored during the pause between cycles. Shah already teaches that the pause is to prevent unwanted tissue damage and Podhajsky teaches that a pause to allow for rehydration prevents overdessication. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Shah/Tanaka combination with the teachings of Podhajsky such that during the pause in Shaw, tissue rehydrates and the hydration level of the tissue is monitored via the impedance during the Twait time period to ensure that the power is only applied once a minimum impedance has been reached to indicate sufficient tissue rehydration, thus preventing adverse tissue effects. However, the Shah/Tanaka/Podhajsky combination is silent to the second power level being higher than the first power level.
Shah discloses an alternate embodiment in which a first power level of 50W is delivered in a first stage and a second power level of 55W is delivered in a second stage. The delivery of the higher power in the second stage reduces the overall time required to seal a higher impedance tissue ([0060]). Shah further discloses that modification of the method to control the RF delivery to seal biological tissue based on the principles defined in the disclosure is within the scope of the invention ([0093]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Fig. 7A such that the second power level is increased to 55W, which is higher than the first power level, to reduce the overall time required to seal high impedance tissues.
Regarding claim 12, the Shah/Tanaka/Podhajsky combination discloses the method of claim 11, wherein the first stopping point is selected from the group consisting of the time at which the tissue achieves a minimum impedance for a minimum amount of time, the time at which the tissue reaches a predetermined impedance measured after a fixed amount of time, the time at which a fixed amount of time has passed, and the time at which a rate of change of impedance of the tissue exceeds a threshold (Shah [0058]: The processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to halt delivery of RF power in response to the tissue impedance reaching a predetermined impedance threshold for a higher impedance tissue – this meets the claim language of achieving a minimum impedance for a minimum amount of time because the minimum impedance is the impedance threshold and the minimum amount of time is the time that it hits the threshold).
Regarding claim 13, the Shah/Tanaka/Podhajsky combination discloses the method of claim 12, wherein the period of time of the second stage comprises a fixed duration ([0058]: the processor waits for a Twait time – this time is fixed for the operation and Shah is silent to the time varying).
Regarding claim 15, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 1. Shah further states that the initial time period to determine that the tissue is of higher impedance type can be 1 second ([0062]).
However, Shah does not explicitly state that this is the exact same for T-1 in Fig. 7A.
The instant application does not provide any criticality to this time frame, and also states that this is a result of the power delivered, vessel size, tissue type, and time to triggering event such as impedance ([0016], [0020]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the initial phase of the combination between 250ms and 1.25 seconds, 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. This is an obvious modification because Shah already contemplates the initial time frame being 1 second and Shah also states that the T1 timeframe is based on the type of tissue and the time it takes the tissue to reach a certain impedance threshold ([0058]), which is the same as the instant application.
Regarding claim 16, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 1, wherein the impedance decreases during the second stage (Podhajsky [0101]: the impedance decreases as the tissue rehydrates).
Regarding claim 17, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 1 as described above. Podhajsky further states that the rehydration phase lasts until the tissue drops below a minimum impedance threshold ([0101]).
However, the combination is silent to the length of this pause.
The instant application states that the duration of the rehydration stage can be determined based on the time it took the tissue to reach certain impedance thresholds in the first stage, which is based on the tissue size, tissue type, handpiece used, and the power delivered ([0018]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the rehydration phase of the combination between 50ms and 250ms, 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. This is an obvious modification because the combination already contemplates adjusting the second stage length based on impedance measurement of the tissue, which is the same as the claimed invention.
Regarding claim 18, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 1, wherein the first power level can be in the range from 1-50 Watts (Shah [0036]) and the second power level is between 40 Watts and 60 Watts (Shah [0058], [0060]: the second stage power can be 50 W or 55W).
However, Shah is specifically silent to the power in the T1 stage being anything other than 50W.
The instant application does not provide any criticality to this first power level. The instant application states, in paragraph [0016], that the power and time of the pre-conditioning are related and the power can be delivered at 20 Watts or 40 Watts, for example. The paragraph goes on to further state that this is simply dependent on the type of tissue and the vessel size. It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the first power level at 25W, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). This is an obvious modification because Shah already contemplates setting the initial power level at less than 50W and the instant application provides no criticality to this power amount.
Regarding claim 19, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 1 as described above. Shah further states that the length of the second power delivery phase is based on the time it takes the tissue to reach an impedance threshold ([0058]).
However, the combination is silent to the stage being between 750 milliseconds and 4 seconds in duration.
The instant application provides no criticality to this timeframe. In paragraph [0020], the instant application states that the timing is dependent upon the tissue being treated and the device conditions, and a desired impedance may be used to determine when to stop. It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the third phase of the combination between 750ms and 4 seconds, 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. This is an obvious modification because Shah already contemplates ending the third stage based on an impedance measurement of the tissue, which is the same as the instant application wherein the timeframe is merely a result of the power delivered and the tissue type meeting the impedance threshold.
Regarding claim 20, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 1 as described above. Tanaka further teaches the preheating phase is preferably between 40°C and 80°C, and once the desired temperature is reached, the preheating is stopped ([0201]).
While Tanaka teaches a range that encompasses the claimed temperature, Tanaka does not explicitly state the temperature is 70°C.
The instant application does not provide criticality to this temperature. It states that the polymerization generally starts around 70°C to 80°C, but the temperature is a result of the power delivered and the time in which the power is delivered ([0016]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to set the target polymerization temperature to 70°C, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). This is an obvious modification because Tanaka already teaches preheating to a range which includes both the claimed temperature and the upper end of the instant application’s polymerization temperature range and the instant application provides no criticality to heating to this specific temperature.
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the Shah/Tanaka/Podhajsky combination as applied to claims 5/3/2/1 and 10 as described above, in view of Shelton et al. (hereinafter ‘Shelton’, US 20190201044 A1).
Regarding claim 6, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 5. The combination further discloses that in response to determination during the initial time window T1 that the tissue has a higher impedance type, the processor 122 monitors impedance of the tissue based upon voltage and current information and the processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to halt delivery of RF power in response to the tissue impedance reaching a predetermined impedance threshold (Shah [0058]).
However, the combination is silent to the variable duration being determined based on the time the tissue required to reach the minimum impedance of the first state or the amount of time for the rate of change of impedance to exceed the threshold in the first stage.
Shelton teaches a system comprising an electrosurgical generator for delivering energy at a surgical site, including RF energy through a bipolar RF energy component ([0213]). The system of Shelton further utilizes a controller that applies a first power until an impedance threshold is reached, implements a pause or dwell time, and then applies a second power ([0434]). The dwell times are set based on the impedance thresholds or the impedance rate of changes such that a predictable sealing time can be achieved ([0410-0411]). The instant application does not provide criticality to the variable duration as it is simply an alternative to a fixed pause duration. Because the determination of the variable duration lacks criticality, and the Shah/Tanaka/Podhajsky combination discloses a system in which impedance is monitored and a variable duration is possible, it would be within the level or ordinary skill in the art to combine the Shah/Tanaka/Podhajsky combination with Shelton. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the invention of the Shah/Tanaka combination with the variable duration determination method of Shelton such that predictable sealing times are achieved.
Regarding claim 14, the Shah/Tanaka/Podhajsky combination discloses the method of claim 10 and described above. The combination further discloses the second stage can comprise a variable duration (Podhajsky [0101]: the energy off time can be based on the time of the tissue to reach a minimum impedance – this is variable as different tissues require different times to reach the threshold). Additionally, Shah discloses that in response to determination during the initial time window T1 that the tissue has a higher impedance type, the processor 122 monitors impedance of the tissue based upon voltage and current information. The processor 122 executes instructions stored in memory 123 to cause the processor to cause the RF output stage 106 to halt delivery of RF power in response to the tissue impedance reaching a predetermined impedance threshold ([0058]).
However, the combination is silent to the variable duration being determined based on the time the tissue required to reach the minimum impedance of the first state or the amount of time for the rate of change of impedance to exceed the threshold in the first stage.
Shelton teaches a system comprising an electrosurgical generator for delivering energy at a surgical site, including RF energy through a bipolar RF energy component ([0213]). The system of Shelton further utilizes a controller that applies a first power until an impedance threshold is reached, implements a pause or dwell time, and then applies a second power ([0434]). The dwell times are set based on the impedance thresholds or the impedance rate of changes such that a predictable sealing time can be achieved ([0410-0411]). The instant application does not provide criticality to the variable duration as it is simply an alternative to a fixed pause duration. Because the determination of the variable duration lacks criticality, and the Shah/Tanaka combination discloses a system in which impedance is monitored and a variable duration is possible, it would be within the level or ordinary skill in the art to combine the Shah/Tanaka combination with Shelton. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the invention of the Shah/Tanaka combination with the variable duration determination method of Shelton such that predictable sealing times are achieved.
Response to Arguments
Applicant's arguments and amendments filed 6/30/2026 regarding the claim objection of claim 14 have been fully considered and are persuasive. The objection to claim 14 has been withdrawn.
Applicant's arguments and amendments filed 6/30/2026 regarding the 112a and 112b rejection of claims 1, 3-8, 10, and 12-20 have been fully considered and are persuasive. The 112 rejections of claims 1, 3-8, 10, and 12-20 have been withdrawn.
Applicant's arguments filed 6/30/2026 regarding the 103 rejections utilizing Shah have been fully considered but are not persuasive. The applicant initially argues that Shah does not teach the pause to allow for rehydration and that rehydration is not inherent in the pause. This is not persuasive. Any blood flow around the site would rehydrate the tissue to some degree. Blood delivers plasma to the tissue which contains water which allows for fluid exchange between the blood and the tissue. Thus, an incomplete seal would allow for rehydration of the tissue because the blood is carrying plasma through the tissue which hydrates it. Additionally, the osmotic movement of water from nearby tissue to hydrate the desiccated tissue rehydrates the tissue to a degree. The claim is not specific to how long this rehydration period lasts, how the controller determines rehydration, or how much the tissue is rehydrated. Any movement of water into the tissue during the pause, no matter how little water that is, rehydrates the tissue and there are multiple inherent ways in which water moves into the tissue. Furthermore, Podhajsky teaches the benefits of rehydration and it would be obvious to ensure the pause allows for rehydration in view of Podhajsky.
The applicant’s arguments regarding Shah and Tanaka have been fully considered but are not persuasive. The applicant states that Shah teaches performing two power sealing steps and modifying Shah to teach an initial, lower power level would not be obvious. This is not persuasive. First, Shah does not state that the first stage fully seals the tissue. In fact, the whole purpose of the second stage is to seal the tissue. Second, Shah teaches a variety of different ways in which power can be applied to the tissue to achieve full sealing. This is evident in Figs. 7A-7C. 7C even discloses an initial, shorter lower power level before the power is raised to a higher power level to achieve a full seal. The approach of Tanaka still achieves a full seal and to protect against non-uniform thermal spread during the application of the sealing phase. Therefore, because Shah contemplates a variety of different power levels and stage timing, it would be obvious to modify Shah in view of Tanaka since the ultimate goal of achieving a full tissue seal is maintained.
Applicant’s arguments regarding Tanaka teaching away from a dehydrating and then rehydrating are not persuasive. Applicant argues that because Tanaka teaches the pre-heating stage decreases the amount of water in the tissue, then it thus discourages any sort of rehydration. This is not persuasive. The tissue dehydrating occurs in any initial power delivery or pre-heating stage. There will be a level of tissue desiccation when heat is applied. The instant application even states that this is a stage in which the collagen is “pre-polymerized” ([0005]). Also, the second stage being labelled a “rehydration” stage indicates that the tissue was previously dehydrated which necessitates the rehydration. While Tanaka is not used to teach the rehydration stage, Tanaka does not teach away from the stage because Tanaka teaches a pause after the pre-heating stage. Tanaka teaches not to fully polymerize the tissue in the first phase. The invention of Tanaka dehydrates sufficiently, pauses which would provide for a degree of rehydration due to blood flow and osmosis, and then goes on to complete sealing as seen in Fig. 15C. Therefore, Tanaka does not teach away from rehydrating the tissue because there is a pause between the preheating and high frequency output, which would allow for some degree of rehydration as explained above. As stated, any pause allows for a degree of rehydration and the instant application does not provide any structure or mechanism for rehydrating the tissue, other than simply pausing for a period of time which Shah and Tanaka both do.
Applicant’s arguments regarding Podhajsky have been fully considered but are not persuasive. The applicant argues that Podhajsky does not teach allowing the tissue to rehydrate, but rather monitors the lack of rehydration to determine whether treatment is complete. This is not persuasive. Podhajsky specifically states that applying energy in pulses allows “the tissue to cool down and also allows for moisture to return to the tissue between pulses which are both known to enhance the sealing process” ([0008]). Podhajsky explicitly states that the pauses allow for rehydration and that it enhances the sealing process. Podhajsky monitors the impedance as described above to monitor the sealing process as well to ensure the desired hydration levels for sealing. Sensing, monitoring and controlling hydration around the energy device ensures that the energy device is ultimately controlled so that energy is delivered to the tissue in the most efficient manner and that the duration of the procedure is the minimum time necessary to achieve the desired tissue effect ([0099]). Therefore, Podhajsky does not teach away from allowing rehydration as Podhajsky explicitly states that allowing for tissue rehydration enhances the sealing process.
Therefore, the rejections of claims 1 and 10 remain.
Therefore, because the rejections of the independent claims 1 and 10 remain, the rejections to the dependent claims remain.
As broadly claimed, the controller is simply applying a lower first power level, pausing, and then applying a second higher power level to seal the tissue. The claim is not specific to specifically how the controller determines the tissue has been rehydrated to the desired level. The generic thresholds of the dependent claims do not add any specific processes other than the measured impedances are compared to threshold values and then the timing can be adjusted. The impedances and the thresholds are not further defined in the claims. Claiming the impedances at which the tissue is actually rehydrated, or claiming the actual degree of tissue rehydration would aid in advancing prosecution. As it stands now, the “rehydration stage” is simply a pause that is determined by the impedance of the tissue in the first stage. Any movement of moisture into the tissue constitutes “rehydration” since the degree of rehydration is not provided and there are multiple ways in which the desiccated tissue rehydrates as described above. A pause determined by the impedance in a first stage is known in the art as explained in the claim rejections above. The controller is not performing any additional steps as claimed to actively rehydrate the tissue. The tissue rehydration is simply a byproduct of the pause. More specificity must be included that actually details the controller monitors the hydration level of the tissue. Any amendments must have support in the specification and would require further search and consideration.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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