DETAILED ACTION
This action is pursuant to claims filed on 12/17/2025. Claims 1, 3-8, 10, and 12-20 are pending, claims 9 and 11 have been cancelled by the applicant and claims 15-20 are new. A non-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 Objections
Claim 14 is objected to because it is dependent upon cancelled claim 11. Claim 14 will be treated as dependent upon claim 10. Appropriate correction is required.
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 1, 3-8, 10, and 12-20 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.
Claims 1 and 10 state “the amount of radiofrequency energy is selected so that any tissue trapped in the pair of jaws will not be heated above a polymerization temperature of the tissue” (emphasis added by the examiner). This statement lacks support in the original disclosure. The specification of the original disclosure states in paragraph [0005] that the stopping point is selected to elevate the temperature of any tissue positioned in the jaws without reaching a full polymerization temperature where any collagen and elastic in the tissue will fully polymerize” (emphasis added by the examiner). This is further clarified in paragraph [0016], which states “the first stage implemented by controller 22 comprises an initial conditioning pulse that is configured to elevate the temperature of the tissue to a level above body temperature, but below the full polymerization temperature of the collagen and elastin in the tissue.” The specification indicates that the collagen and elastin of the tissue will not fully polymerize, not that any tissue trapped in the jaws will not be heated above a polymerization temperature. The newly amended claim indicates that the temperature is selected such that there will be no polymerization of any tissue in the first stage. This lacks support. The specification of the instant application indicates that the polymerization temperature is based on that of the collagen and the elastin, not the tissue as a whole. Additionally, the instant application states that the initial stage “provide[s] energy according to a scheme that conditions the tissue to be treated to be homogeneous by pre-polymerizing collagen” ([0005]). Thus, there is a degree of polymerization that occurs in the collagen. Therefore, because the original disclosure indicates that the temperature in the first stage is selected to prevent full polymerization of the collagen and elastin and makes no mention of the energy being selected so that any tissue trapped in the pair of jaws will not be heated above a polymerization temperature of the tissue, the claims are rejected as introducing new subject matter not present in the original filing.
Claims 1 and 10 are also rejected because they state the interruption of “radiofrequency energy in a second stage for a period of time that is sufficient to allow for rehydration […] as determined by the impedance of the tissue remaining below a threshold for a predetermined period of time commencing at the end of the first stage” (emphasis added by examiner). There is not support in the original disclosure for the bolded statement. In paragraph [0018], the specification of the instant application states “the predetermined period of time may comprise a fixed duration or a variable duration. The variable duration may be determined based on the time that the tissue took to reach the predetermined minimum impedance of the conditioning pulse in the first stage, the particular type of handpiece being used, or the amount of time for the rate of impedance change to exceed the predetermined threshold in the first stage.” This clearly states that the impedance thresholds used to determine the variable duration of the second stage are based on the time to reach threshold impedances in the first stage, not the impedance remaining below a threshold for a period of time starting at the end of the first stage. Paragraph [0020], where it appears this statement has been taken from, states “the end of stage 102, tstop, can occur after or a fixed time or after the measured tissue impedance is at or below impedance threshold Zth for a minimum amount of time or the measured tissue impedance is at or below the threshold Zth after a fixed amount of time.” However, stage 102 is the first conditioning stage, not the second rehydration stage. Therefore, the claims are rejected because this statement introduces new matter as there is not support in the original disclosure for this newly amended statement. It does not appear in the original disclosure and the original disclosure only states that the rehydration time is varied based on impedance thresholds met during the first stage, not during the second stage.
Claims 3-8 and 12-20 are rejected as being dependent upon rejected independent claims.
Claim 17 is rejected because it states the “second stage is between 250 milliseconds and 1.25 second in duration.” This is new subject matter that was not present in the original disclosure. Paragraph [0020] of the instant application states “rehydration state 104 would likely not exceed 250ms, and will probably be closer to 50ms.” The original disclosure makes no mention of the rehydration stage falling within the claimed timeframe. Therefore, the claim is rejected for introducing new subject 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 1, 3-8, 10, and 12-20 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.
Claims 1 and 10 are rejected because “sufficient to allow for rehydration” is not defined in the instant application. It is unclear what tissue effect is intended by sufficient rehydration. The claim does not indicate the time, impedance measurement, or tissue property that would indicate a sufficient timeframe for rehydration. Furthermore, the generic impedance threshold that was introduced in the amendment does not rectify this issue. The amendment does not define the threshold or the predetermined period of time. It simply states the tissue meets a generic threshold for a generic time period without clarifying what “sufficient” is intended to mean. Therefore, the claims are rejected for failing to define the metes and bounds of the invention because it is indefinite as to what “sufficient to allow for rehydration” is as it pertains to the tissue’s condition. For the purposes of compact prosecution, this will be interpreted as a pause in the delivery of RF energy prior to complete sealing which would inherently allow for a degree of rehydration as there would be blood flow to the tissue because the vessel sealing is incomplete.
The examiner recommends removing the word “sufficient” because it is not defined in the instant application. A pause would inherently provide for a degree of rehydration, but there is no mention of what “sufficient” means as it relates to the tissue rehydration stage.
Claims 1 and 10 also state “the amount of radiofrequency energy is selected so that any tissue trapped in the pair of jaws will not be heated above a polymerization temperature of the tissue” (emphasis added by the examiner). This statement lacks support in the original disclosure and is therefore indefinite. The specification of the original disclosure states in paragraph [0005] that the stopping point is selected to elevate the temperature of any tissue positioned in the jaws without reaching a full polymerization temperature where any collagen and elastic in the tissue will fully polymerize” (emphasis added by the examiner). This is further clarified in paragraph [0016], which states “the first stage implemented by controller 22 comprises an initial conditioning pulse that is configured to elevate the temperature of the tissue to a level above body temperature, but below the full polymerization temperature of the collagen and elastin in the tissue.” The specification indicates that the collagen and elastin of the tissue will not fully polymerize, not that any tissue trapped in the jaws will not be heated above a polymerization temperature. The newly amended claim indicates that the temperature is selected such that there will be no polymerization of any tissue in the first stage. This lacks support. The specification of the instant application indicates that the polymerization temperature is based on that of the collagen and the elastin, not the tissue as a whole. Additionally, the instant application states that the initial stage “provide[s] energy according to a scheme that conditions the tissue to be treated to be homogeneous by pre-polymerizing collagen” ([0005]). Thus, there is a degree of polymerization that occurs in the collagen. Therefore, because the original disclosure indicates that the temperature in the first stage is selected to prevent full polymerization of the collagen and elastin and makes no mention of the energy being selected so that any tissue trapped in the pair of jaws will not be heated above a polymerization temperature of the tissue, the claims are rejected as indefinite for contradicting the original disclosure.
Claims 1 and 10 are also rejected because they state the interruption of “radiofrequency energy in a second stage for a period of time that is sufficient to allow for rehydration […] as determined by the impedance of the tissue remaining below a threshold for a predetermined period of time commencing at the end of the first stage” (emphasis added by examiner). There is not support in the original disclosure for the bolded statement. In paragraph [0018], the specification of the instant application states “the predetermined period of time may comprise a fixed duration or a variable duration. The variable duration may be determined based on the time that the tissue took to reach the predetermined minimum impedance of the conditioning pulse in the first stage, the particular type of handpiece being used, or the amount of time for the rate of impedance change to exceed the predetermined threshold in the first stage.” This clearly states that the impedance thresholds used to determine the variable duration of the second stage are based on the time to reach threshold impedances in the first stage, not the impedance remaining below a threshold for a period of time starting at the end of the first stage. Paragraph [0020], where it appears this statement has been taken from, states “the end of stage 102, tstop, can occur after or a fixed time or after the measured tissue impedance is at or below impedance threshold Zth for a minimum amount of time or the measured tissue impedance is at or below the threshold Zth after a fixed amount of time.” However, stage 102 is the first conditioning stage, not the second rehydration stage. Therefore, the claims are rejected because the newly amended statement does not have support in the original disclosure and renders the claim indefinite. The contradiction between the claims, which requires the impedance to remain below a threshold for a predetermined period of time commencing at the end of the first stage, and the specification, which bases the second stage time on the thresholds being met in the first stage, renders the claims indefinite.
Claims 3-8 and 15-20 are rejected due to their dependance on claim 1.
Claims 12-14 are rejected due to their dependance on claim 10.
Claims 4 and 13 are rejected because they state that the period of time of the second stage comprises a fixed duration. This contradicts claims 1 and 10 which state the second stage time length is determined by the impedance of the tissue remaining below a threshold for a predetermined period of time. The specification of the instant application states that the predetermined period of time can be a fixed duration or a variable duration based on the amount of time it took for the tissue to reach a minimum impedance in the first stage ([0018]). The second stage cannot both be a fixed duration and rely on meeting a certain impedance threshold because different tissues would require different times to meet the threshold. Thus, it can either be a fixed amount of time, or a variable amount of time based on the tissue impedance thresholds. Therefore, the claims are rejected because this contradiction renders the claim indefinite.
Claims 6 and 14 are rejected because they state “the variable duration is determined based on the amount of time the tissue required to reach the minimum impedance of the first stage or the amount of time for the rate of change of impedance to exceed the threshold in the first stage.” This contradicts claims 1 and 10 which state the interruption of “radiofrequency energy in a second stage for a period of time that is sufficient to allow for rehydration […] as determined by the impedance of the tissue remaining below a threshold for a predetermined period of time commencing at the end of the first stage.” Claim 1 indicates that the time to achieve sufficient rehydration is based on the impedance being below a threshold for a predetermined period of time commencing at the end of the first stage, not the times to reach impedance thresholds during the first stage. It is unclear how both statements can be true. Either the second stage timing is based on the time to reach the impedance thresholds in the first stage, or the tissue staying below a threshold in the second stage for a period of time in the second stage, but not both. Therefore, the claim is indefinite because there are two conflicting requirements that determine the length of the second rehydration stage.
Claim 17 is rejected because it states the “second stage is between 250 milliseconds and 1.25 second in duration.” This is new subject matter that was not present in the original disclosure. Paragraph [0020] of the instant application states “rehydration state 104 would likely not exceed 250ms, and will probably be closer to 50ms.” The original disclosure makes no mention of the rehydration stage falling within the claimed timeframe. Therefore, because this limitation was not present in the original disclosure and contradicts the original disclosure, the claim is indefinite.
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), 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);
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),
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) that is sufficient 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; “sufficient” is not defined by a timeframe, impedance, or specific tissue property), 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 an inherent 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. 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 sufficient to allow for rehydration being determined by the impedance of the tissue remaining below a threshold for a predetermined period of time commencing at the end of the first stage.
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 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 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 5, the Shah/Tanaka/Podhajsky combination discloses the electrosurgical system of claim 3 as described above, wherein the period of the second stage comprises a 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) that is sufficient 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; “sufficient” is not defined by a timeframe, impedance, or specific tissue property), and to output sufficient 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. 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 sufficient to allow for rehydration being determined by the impedance of the tissue remaining below a threshold for a predetermined period of time commencing at the end of the first stage.
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 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 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 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 11/10 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 12/17/2025 regarding the 112b rejection of claim 9 have been fully considered but they are not persuasive because the amendments do not clarify what “sufficient” means as it relates to rehydration and introduces new 112a and 112b rejections as explained above.
Applicant's arguments filed 12/17/2025 regarding the 103 rejections utilizing Shah have been fully considered but are not persuasive. The applicant initially argues that Shah discloses a single power delivery achieves a full sealing of the tissue and is not pre-heating the tissue because a high-power level is used. This is not persuasive. The impedance threshold which is met in the first stage is “a predetermined impedance threshold Zhth for a higher impedance tissue.” ([0058]). It does not state that this is a high impedance threshold, but rather an impedance threshold for higher impedance tissue, which is based on the tissue type. The second power delivery is used for sealing because Shah states that delivery of “two consecutive RF power leads to a better seal on higher impedance tissue” ([0058]). Two consecutive RF power deliveries with a waiting time in between is the same power delivery as the instant application. Furthermore, the power of the first stage is not critical. Shah states in paragraph [0036] that the first power level can range from 1-50 Watts. The instant application also states that the power in the first stage can be as high as 40 Watts ([0016]). The instant application even states that the temperature of the tissue is a function of the power delivered and the time in which it is delivered ([0016]). Thus, delivering 50 Watts does not guarantee sealing since it is dependent upon the time which it is applied to the tissue. Thus, Shah still discloses the claim as currently recited.
Applicant’s arguments regarding the impedance only decreasing in the first stage are not persuasive. The claim states that the “impedance of the tissue will decrease between a beginning of the first stage and an end of the first stage.” The claim does not require the impedance only decrease. Shah shows in Fig. 7A a decrease in impedance before the impedance increases. Thus, Shah still discloses the claim as currently recited.
Applicant’s arguments regarding Shah as it pertains to the rehydration stage are not persuasive. The effect of the waiting period is an inherent result of stopping energy delivery. If power delivery is stopped, there will water will inherently diffuse into the drier tissue. The claim does not provide any specific structure that causes the tissue to rehydrate. Furthermore, Podhajsky is used to teach the newly recited parameters of the rehydration stage.
Applicant’s arguments regarding the first and second power levels not being different is not persuasive. As described above, Shah teaches an alternate embodiment in which a second, higher power level is used in the second stage. The rejection of record combines the embodiment of Fig. 7A with that of Fig. 7C in order to utilize a higher second power level to improve sealing in high impedance tissues. The rationale for the combination is described above. The combination of Fig. 7A with the other embodiment of Shah was not specifically challenged in the argument, and thus the rejection remains.
Applicant’s arguments regarding the Shah/Tanaka combination are not persuasive. Applicant initially argues that it would not be proper to combine Shah and Tanaka to reach the claimed invention because Tanaka teaches the pre-heating stage decreases the amount of water in the tissue. This is an inherent occurrence of any 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. Therefore, during the pause between the first and second phases, there is inherently some level of rehydration of the tissue. As stated, any pause allows for an inherent 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 Shelton have been fully considered by are not persuasive because the applicant does not specifically challenge the application of Shelton.
Applicant’s arguments regarding Gaspredes have been fully considered but are moot because the claim that Gaspredes was used to reject has been cancelled by the applicant.
Therefore, because the rejections of the independent claims 1 and 10 remain, the rejections to the dependent claims remain.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./ Examiner, Art Unit 3794