DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed June 15, 2026 (“06/15/26 Amendment") has been entered, and fully considered. In the 06/15/26 Amendment, claims 1, 5, & 10-14 were amended, and claim 16 was newly added. No claims were cancelled. Accordingly, claims 1-16 are now pending in the application.
3. The 06/15/26 Amendment has overcome the claim rejections under §§ 112(b), 102, & 103 previously set forth in the Non-Final Office Action mailed 03/19/26 (“03/19/26 Action”).
4. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 103
5. 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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. Claims 1, 2, 4, 5, 7-9, 11, 13, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2021/0196368 to Pope et al. (“Pope”) in view of U.S. 2005/0203504 to Wham et al. ("Wham").
8. Regarding claim 1, Pope teaches a treatment tool generator comprising:
a power source [electrosurgical generator (10) - ¶’s [0024], [0025]; FIG. 1] configured to supply power to a treatment tool [electrosurgical instrument (20) - ¶’s [0024], [0036]; FIG. 2]; and
a processor [processor - e.g., ¶’s [0032], [0070], [0216]] configured to control an operation of the power source [(10)] and the treatment tool [(20)] [e.g., ¶’s [0032], [0070]], the processor being configured to:
cause the power source [(10)] to supply the power to the treatment tool [(20)] to apply a treatment energy to a biological tissue from the treatment tool [e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))],
calculate a thickness index value to be an index of a thickness dimension [tissue thickness] of the biological tissue that is grasped by the treatment tool [e.g., ¶’s [0151]-[0156]]…,
determine whether it is a change timing [e.g., when a gradual voltage ramp for the RF energy should be terminated] to change a control state of at least one of the power source [(10)] and the treatment tool [(20)] based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174] concerning windows of time used for determining maximum current peaks]…, and
perform at least one of a first control, a second control, and a third control upon determining that it is the change timing,
the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing [e.g., ¶’s [0159]-[0162]]…,
[optional] the second control including increasing a grasping force to grasp the biological tissue by the treatment tool, and
[optional] the third control including decreasing the grasping force to grasp the biological tissue by the treatment tool for a predetermined time period.
TEMPORAL CHANGE OF THICKNESS INDEX VALUE
While Pope teaches calculating the thickness of the tissue being sealed, Pope appears to do so in order to select RF energy levels based on a comparison with stored voltage profiles/templates used for tissues having similar thicknesses [e.g., ¶’s [0092]-[0095], [0151]-[0156]].
As such, Pope does not teach the following emphasized claim limitations:
calculate a thickness index value to be an index of a thickness dimension of the biological tissue that is grasped by the treatment tool, the thickness index value being calculated over time after the treatment energy is applied to the biological tissue,
determine whether it is a change timing to change a control state of at least one of the power source and the treatment tool based on the thickness index value, the change timing being determined based on a temporal change of the thickness index value after the treatment energy is applied, the temporal change indicating an expansion of the biological tissue and a subsequent decrease in the thickness index value, and…
the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing such that an amount of the power during the predetermined time period immediately after the change timing is smaller than an amount of the power during a predetermined time period immediately before the change timing…
Wham, in a similar field of endeavor, teaches a system and method for controlling an electrosurgical generator that generates electrosurgical energy for delivery to a patient for sealing tissue during an electrosurgical procedure [e.g., Abstract].
More particularly, Wham teaches a closed loop control system (100) comprising, inter alia, a control module (102) and a sensor module (110). The control module (102) is operatively connected to an electrosurgical generator (101), and controls energy delivery by an electrosurgical instrument (e.g., an end-effector having jaws for grasping, dissecting and/or clamping tissue, such as for constricting vessels, and at least one delivery device for delivering surgical energy) to a patient [¶’s [0032]-[0033]].
The sensor module (110) senses various electrical and/or physical parameters or properties at the operating site (e.g., voltage, current, power and impedance across the tissue (tissue impedance), tissue temperature, leakage current, applied voltage, applied current, tissue thickness, volume of tissue between jaws of electrosurgical instrument, tissue light transmission, reflectivity and/or absorption properties, tissue moisture content level, tissue elastomeric properties, tissue viability and/or tissue reactive pressure) and communicates with the control module (102) to regulate electrosurgical output [e.g., ¶[0034]].
Wham further teaches that sensor module (110) may include sensing elements placed at opposite surfaces of the tissue for generating a tissue thickness value pre-surgery, as well as during a surgical procedure [see ¶[0063] (“As described above, the sensor module 110 includes a proximity sensor having sensing elements placed at opposite surfaces of the tissue for sensing the distance between the sensing elements for sensing (e.g., measuring) tissue thickness at the surgical site "B", and generating a tissue thickness value. An initial tissue thickness value may be provided to the control module 102 as a pre-surgical parameter. Sensed real-time tissue thickness values and/or changes in tissue thickness values over time (Δ (difference) thickness/ Δ(difference) time) may further be provided to the control module 102 during the surgical procedure, where the control module 102 modulates the energy output in accordance with the sensed real-time tissue thickness values, changes in tissue thickness values, rate of change of tissue thickness over time and/or relative value of real-time measured tissue thickness values to the initial tissue thickness value”)].
Wham further teaches that it was known/appreciated in the art* that a temporal change in a thickness index value during a sealing process typically includes a decrease in tissue thickness due to expansion of the biological tissue [e.g., ¶[0066] (“Tissue typically shrinks during sealing due to dessication of the tissue”); *See also the “Citation of Pertinent Prior Art” section (below)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pope to further include calculations of the thickness index value based on a temporal change during an electrosurgical sealing process (i.e., after application of the treatment energy has commenced, and during which time the biological tissue being treated will expand resulting in a decreased thickness index value), as taught by Wham, and to use such calculations in determining whether it is a change timing in Pope [e.g., whether the gradual voltage ramp for the RF energy should be terminated], since calculations of tissue thickness in real-time during a procedure can be used to, e.g., track the expected tissue behavior based on the selected template/profile of Pope with actual tissue behavior during the procedure, and modify RF energy delivery accordingly, thereby optimizing RF energy delivery during a procedure to improve outcomes.
Finally, it is noted that the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing will result in an amount of the power during the predetermined time period immediately after the change timing being smaller than an amount of the power during a predetermined time period immediately before the change timing [Examiner notes that, e.g., suspending power will naturally (and expectedly) result in an amount of power being smaller (e.g., “zero” during a suspension of power) than the amount of power being applied immediately prior to the suspension].
9. Regarding claim 2, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further teaches wherein the processor is configured to increase the power after temporarily reducing or suspending the power for the predetermined time period in the first control [e.g., ¶[0158] (“the electrosurgical system can then modify the voltage of the RF energy to drop to a lower voltage amount and subsequently gradually rise the voltage level in order to maintain the temperature of the tissue (and in turn control the vaporization of the fluid/water in the tissue at a controlled rate)”].
10. Regarding claim 4, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further teaches wherein the processor is configured to determine, as the change timing, a point of time when a product of a change amount in the thickness index value and a predetermined time period crosses a specific first threshold [e.g., ¶[0162]].
11. Regarding claim 5, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further teaches wherein the processor is configured to determine, as the change timing, a point of time when a change rate of the thickness index value becomes lower than a predetermined threshold [e.g., ¶[0170]].
12. Regarding claim 7, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further teaches wherein the thickness index value is a value that is calculated from at least one of electric current [maximum current - ¶’s [0151]-[0155]], voltage, phase information of the current, and phase information of the voltage, the current and the voltage being applied as the power.
13. Regarding claim 8, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further teaches wherein the processor is configured to change a reduction amount of the power based on the thickness index value in the first control [e.g., ¶’s [0155], [0161]].
14. Regarding claim 9, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further teaches wherein when the change timing is determined a plurality of times chronologically, the processor is configured to decrease a reduction amount of the power at the change timing that is later in chronological order in a plurality of change timings determined at the plurality of times, in the first control [see the discussion in ¶’s [0164]-[0173] concerning identifying maximum current peaks, and more particularly, the drawbacks of relying on earlier/prior (erroneous) maximum peaks occurring during an initial time window, and hence the use of continued monitoring beyond the initial time window]. See also Wham at, e.g., ¶[0063]].
15. Regarding claim 11, Pope teaches a treatment system comprising:
a treatment tool [electrosurgical instrument (20) - ¶’s [0024], [0036]; FIG. 2];
a treatment tool generator [electrosurgical generator (10) - ¶’s [0024], [0025]; FIG. 1] configured to control an operation of the treatment tool [(20)] [¶’s [0025], [0036]], wherein
the treatment tool generator [(10)] includes:
a power source [as part of generator (10) - ¶’s [0026]-[0029]] configured to supply power to the treatment tool [(20)]; and
a processor [processor - e.g., ¶’s [0032], [0070], [0216]] configured to control an operation of the power source [(10)] and the treatment tool [(20)] [e.g., ¶’s [0032], [0070]], and
the processor is configured to:
cause the power source [(10)] to supply the power to the treatment tool [(20)] to apply a treatment energy to a biological tissue from the treatment tool [e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))],
calculate a thickness index value to be an index of a thickness dimension [tissue thickness] of the biological tissue that is grasped by the treatment tool [e.g., ¶’s [0151]-[0156]],
determine whether it is a change timing [e.g., when a gradual voltage ramp for the RF energy should be terminated] to change a control state of at least one of the power source [(10)] and the treatment tool [(20)] based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174] concerning windows of time used for determining maximum current peaks]..., and
perform at least one of a first control, a second control, and a third control upon determining that it is the change timing, the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing [e.g., ¶’s [0159]-[0162]]...,
[optional] the second control including increasing a grasping force to grasp the biological tissue by the treatment tool, and
[optional] the third control including decreasing the grasping force to grasp the biological tissue by the treatment tool for a predetermined time period.
TEMPORAL CHANGE OF THICKNESS INDEX VALUE
While Pope teaches calculating the thickness of the tissue being sealed, Pope appears to do so in order to select RF energy levels based on a comparison with stored voltage profiles/templates used for tissues having similar thicknesses [e.g., ¶’s [0092]-[0095], [0151]-[0156]].
As such, Pope does not teach the following emphasized claim limitations:
calculate a thickness index value to be an index of a thickness dimension of the biological tissue that is grasped by the treatment tool, the thickness index value being calculated over time after the treatment energy is applied to the biological tissue,
determine whether it is a change timing to change a control state of at least one of the power source and the treatment tool based on the thickness index value, the change timing being determined based on a temporal change of the thickness index value after the treatment energy is applied, the temporal change indicating an expansion of the biological tissue and a subsequent decrease in the thickness index value, and…
the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing such that an amount of the power during the predetermined time period immediately after the change timing is smaller than an amount of the power during a predetermined time period immediately before the change timing…
Wham, in a similar field of endeavor, teaches a system and method for controlling an electrosurgical generator that generates electrosurgical energy for delivery to a patient for sealing tissue during an electrosurgical procedure [e.g., Abstract].
More particularly, Wham teaches a closed loop control system (100) comprising, inter alia, a control module (102) and a sensor module (110). The control module (102) is operatively connected to an electrosurgical generator (101), and controls energy delivery by an electrosurgical instrument (e.g., an end-effector having jaws for grasping, dissecting and/or clamping tissue, such as for constricting vessels, and at least one delivery device for delivering surgical energy) to a patient [¶’s [0032]-[0033]].
The sensor module (110) senses various electrical and/or physical parameters or properties at the operating site (e.g., voltage, current, power and impedance across the tissue (tissue impedance), tissue temperature, leakage current, applied voltage, applied current, tissue thickness, volume of tissue between jaws of electrosurgical instrument, tissue light transmission, reflectivity and/or absorption properties, tissue moisture content level, tissue elastomeric properties, tissue viability and/or tissue reactive pressure) and communicates with the control module (102) to regulate electrosurgical output [e.g., ¶[0034]].
Wham further teaches that sensor module (110) may include sensing elements placed at opposite surfaces of the tissue for generating a tissue thickness value pre-surgery, as well as during a surgical procedure [see ¶[0063] (“As described above, the sensor module 110 includes a proximity sensor having sensing elements placed at opposite surfaces of the tissue for sensing the distance between the sensing elements for sensing (e.g., measuring) tissue thickness at the surgical site "B", and generating a tissue thickness value. An initial tissue thickness value may be provided to the control module 102 as a pre-surgical parameter. Sensed real-time tissue thickness values and/or changes in tissue thickness values over time (Δ (difference) thickness/ Δ(difference) time) may further be provided to the control module 102 during the surgical procedure, where the control module 102 modulates the energy output in accordance with the sensed real-time tissue thickness values, changes in tissue thickness values, rate of change of tissue thickness over time and/or relative value of real-time measured tissue thickness values to the initial tissue thickness value”)].
Wham further teaches that it was known/appreciated in the art* that a temporal change in a thickness index value during a sealing process typically includes a decrease in tissue thickness due to expansion of the biological tissue [e.g., ¶[0066] (“Tissue typically shrinks during sealing due to dessication of the tissue”); *See also the “Citation of Pertinent Prior Art” section (below)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pope to further include calculations of the thickness index value based on a temporal change during an electrosurgical sealing process (i.e., after application of the treatment energy has commenced, and during which time the biological tissue being treated will expand resulting in a decreased thickness index value), as taught by Wham, and to use such calculations in determining whether it is a change timing in Pope [e.g., whether the gradual voltage ramp for the RF energy should be terminated], since calculations of tissue thickness in real-time during a procedure can be used to, e.g., track the expected tissue behavior based on the selected template/profile of Pope with actual tissue behavior during the procedure, and modify RF energy delivery accordingly, thereby optimizing RF energy delivery during a procedure to improve outcomes.
Finally, it is noted that the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing will result in an amount of the power during the predetermined time period immediately after the change timing being smaller than an amount of the power during a predetermined time period immediately before the change timing [Examiner notes that, e.g., suspending power will naturally (and expectedly) result in an amount of power being smaller (e.g., “zero” during a suspension of power) than the amount of power being applied immediately prior to the suspension].
16. Regarding claim 13, Pope teaches a control method performed by a processor [processor - e.g., ¶’s [0032], [0070], [0216]] of a treatment tool generator [electrosurgical generator (10) - ¶’s [0024], [0025]; FIG. 1], the method comprising:
supplying power to a treatment tool [electrosurgical instrument (20) - ¶’s [0024], [0036]; FIG. 2] grasping a biological tissue [e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))] from a power source [as part of generator (10) - ¶’s [0026]-[0029]] to apply a treatment energy to the biological tissue from the treatment tool [(20)];
calculating a thickness index value to be an index value of a thickness dimension [tissue thickness] of the biological tissue grasped by the treatment tool [e.g., ¶’s [0151]-[0156]]...;
determining whether it is a change timing [e.g., when a gradual voltage ramp for the RF energy should be terminated] to change a control state of at least one of the power source [(10)] and the treatment tool [(20)] based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174] concerning windows of time used for determining maximum current peaks]; and
performing at least one of a first control, a second control, and a third control upon determining that it is the change timing, the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period [e.g., ¶’s [0159]-[0162]],
[optional] the second control including increasing a grasping force to grasp the biological tissue by the treatment tool, and
[optional] the third control including decreasing the grasping force to grasp the biological tissue by the treatment tool for a predetermined time period.
TEMPORAL CHANGE OF THICKNESS INDEX VALUE
While Pope teaches calculating the thickness of the tissue being sealed, Pope appears to do so in order to select RF energy levels based on a comparison with stored voltage profiles/templates used for tissues having similar thicknesses [e.g., ¶’s [0092]-[0095], [0151]-[0156]].
As such, Pope does not teach the following emphasized claim limitations:
calculate a thickness index value to be an index of a thickness dimension of the biological tissue that is grasped by the treatment tool, the thickness index value being calculated over time after the treatment energy is applied to the biological tissue,
determine whether it is a change timing to change a control state of at least one of the power source and the treatment tool based on the thickness index value, the change timing being determined based on a temporal change of the thickness index value after the treatment energy is applied, the temporal change indicating an expansion of the biological tissue and a subsequent decrease in the thickness index value, and…
the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing such that an amount of the power during the predetermined time period immediately after the change timing is smaller than an amount of the power during a predetermined time period immediately before the change timing…
Wham, in a similar field of endeavor, teaches a system and method for controlling an electrosurgical generator that generates electrosurgical energy for delivery to a patient for sealing tissue during an electrosurgical procedure [e.g., Abstract].
More particularly, Wham teaches a closed loop control system (100) comprising, inter alia, a control module (102) and a sensor module (110). The control module (102) is operatively connected to an electrosurgical generator (101), and controls energy delivery by an electrosurgical instrument (e.g., an end-effector having jaws for grasping, dissecting and/or clamping tissue, such as for constricting vessels, and at least one delivery device for delivering surgical energy) to a patient [¶’s [0032]-[0033]].
The sensor module (110) senses various electrical and/or physical parameters or properties at the operating site (e.g., voltage, current, power and impedance across the tissue (tissue impedance), tissue temperature, leakage current, applied voltage, applied current, tissue thickness, volume of tissue between jaws of electrosurgical instrument, tissue light transmission, reflectivity and/or absorption properties, tissue moisture content level, tissue elastomeric properties, tissue viability and/or tissue reactive pressure) and communicates with the control module (102) to regulate electrosurgical output [e.g., ¶[0034]].
Wham further teaches that sensor module (110) may include sensing elements placed at opposite surfaces of the tissue for generating a tissue thickness value pre-surgery, as well as during a surgical procedure [see ¶[0063] (“As described above, the sensor module 110 includes a proximity sensor having sensing elements placed at opposite surfaces of the tissue for sensing the distance between the sensing elements for sensing (e.g., measuring) tissue thickness at the surgical site "B", and generating a tissue thickness value. An initial tissue thickness value may be provided to the control module 102 as a pre-surgical parameter. Sensed real-time tissue thickness values and/or changes in tissue thickness values over time (Δ (difference) thickness/ Δ(difference) time) may further be provided to the control module 102 during the surgical procedure, where the control module 102 modulates the energy output in accordance with the sensed real-time tissue thickness values, changes in tissue thickness values, rate of change of tissue thickness over time and/or relative value of real-time measured tissue thickness values to the initial tissue thickness value”)].
Wham further teaches that it was known/appreciated in the art* that a temporal change in a thickness index value during a sealing process typically includes a decrease in tissue thickness due to expansion of the biological tissue [e.g., ¶[0066] (“Tissue typically shrinks during sealing due to dessication of the tissue”); *See also the “Citation of Pertinent Prior Art” section (below)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pope to further include calculations of the thickness index value based on a temporal change during an electrosurgical sealing process (i.e., after application of the treatment energy has commenced, and during which time the biological tissue being treated will expand resulting in a decreased thickness index value), as taught by Wham, and to use such calculations in determining whether it is a change timing in Pope [e.g., whether the gradual voltage ramp for the RF energy should be terminated], since calculations of tissue thickness in real-time during a procedure can be used to, e.g., track the expected tissue behavior based on the selected template/profile of Pope with actual tissue behavior during the procedure, and modify RF energy delivery accordingly, thereby optimizing RF energy delivery during a procedure to improve outcomes.
Finally, it is noted that the first control including reducing or suspending the power being supplied to the treatment tool from the power source for a predetermined time period immediately after the change timing will result in an amount of the power during the predetermined time period immediately after the change timing being smaller than an amount of the power during a predetermined time period immediately before the change timing [Examiner notes that, e.g., suspending power will naturally (and expectedly) result in an amount of power being smaller (e.g., “zero” during a suspension of power) than the amount of power being applied immediately prior to the suspension].
17. Regarding claim 16, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope (as modified) further teaches wherein the biological tissue is a blood vessel [e.g., an artery – see ¶[0151]] including a media and an adventitia [those skilled in the art will readily appreciate that arteries include a media and an adventitia], the processor is configured to determine the change timing before vapor generated between the media and the adventitia increases explosively [e.g.,¶[0165] (“minimize or prevent damage to the tissue caused by overexposure of high amounts of RF energy”)], and the first control is performed to suppress separation between the media and the adventitia [the first control of suspending the power being supplied will have this effect].
18. Claims 3, 10, 12, 14, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of Wham, and further in view of U.S. 2019/0021757 to Kobayashi et al. ("Kobayashi").
19. Regarding claim 3, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Pope and Wham does not, however, teach:
wherein the processor is configured to increase the grasping force after temporarily decreasing the grasping force for the predetermined time period in the third control.
Kobayashi, in a similar field of endeavor, teaches an energy treatment instrument (2) and energy controller (3) [¶[0026]; FIG. 1]. The energy treatment instrument (2) comprises an end effector (6) configured such that a treatment target can be grasped between first and second grasping pieces (13, 14) thereof [¶’s [0027], [0029], [0030]].
Kobayashi further teaches that the energy controller (3) includes a processor (47) which includes a drive controller (52) [¶’s [0032]-[0033]]. The drive controller (52) determines a parameter regarding the grasping force applied to the treatment target grasped between the grasping pieces (13, 14) based on thickness of the target [¶’s [0033]-[0034]], and is further configured to control a grasping force adjustment unit (41) which can be actuated to adjust the grasping force applied between the grasping pieces (13, 14) [¶’s [0033]-[0034]] based on thickness.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pope and Wham such that the processor be capable of increasing and/or decreasing grasping force as necessary according to desired control routines, based on determined target thickness, including, e.g., wherein the processor is configured to increase the grasping force after temporarily decreasing the grasping force for the predetermined time period in the third control, since such a modification would improve sealing treatment and treatment performance by further enabling force control (as taught by Kobayashi [e.g., ¶’s [0097]-[0098]]) in addition to the energy control of Pope.
20. Regarding claim 10, Pope teaches a treatment tool generator comprising:
a power source [electrosurgical generator (10) - ¶’s [0024], [0025]; FIG. 1] configured to supply power to a treatment tool [electrosurgical instrument (20) - ¶’s [0024], [0036]; FIG. 2]; and
a processor [processor - e.g., ¶’s [0032], [0070], [0216]] configured to control an operation of the power source [(10)] [e.g., ¶’s [0032], [0070]], the processor being configured to:
cause the power source [(10)] to supply the power to the treatment tool [(20)] to apply a treatment energy to a biological tissue from the treatment tool [e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))],
calculate a thickness index value to be an index of a thickness dimension [tissue thickness] of the biological tissue that is grasped by the treatment tool [e.g., ¶’s [0151]-[0156]]...,
determine whether it is a change timing [e.g., when a gradual voltage ramp for the RF energy should be terminated]... based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174] concerning windows of time used for determining maximum current peaks]…,
A. TEMPORAL CHANGE OF THICKNESS INDEX VALUE
While Pope teaches calculating the thickness of the tissue being sealed, Pope appears to do so in order to select RF energy levels based on a comparison with stored voltage profiles/templates used for tissues having similar thicknesses [e.g., ¶’s [0092]-[0095], [0151]-[0156]].
As such, Pope does not teach the following emphasized claim limitations:
calculate a thickness index value to be an index of a thickness dimension of the biological tissue that is grasped by the treatment tool, the thickness index value being calculated over time after the treatment energy is applied to the biological tissue,
determine whether it is a change timing... based on the thickness index value, the change timing being determined based on a temporal change of the thickness index value after the treatment energy is applied,
Wham, in a similar field of endeavor, teaches a system and method for controlling an electrosurgical generator that generates electrosurgical energy for delivery to a patient for sealing tissue during an electrosurgical procedure [e.g., Abstract].
More particularly, Wham teaches a closed loop control system (100) comprising, inter alia, a control module (102) and a sensor module (110). The control module (102) is operatively connected to an electrosurgical generator (101), and controls energy delivery by an electrosurgical instrument (e.g., an end-effector having jaws for grasping, dissecting and/or clamping tissue, such as for constricting vessels, and at least one delivery device for delivering surgical energy) to a patient [¶’s [0032]-[0033]].
The sensor module (110) senses various electrical and/or physical parameters or properties at the operating site (e.g., voltage, current, power and impedance across the tissue (tissue impedance), tissue temperature, leakage current, applied voltage, applied current, tissue thickness, volume of tissue between jaws of electrosurgical instrument, tissue light transmission, reflectivity and/or absorption properties, tissue moisture content level, tissue elastomeric properties, tissue viability and/or tissue reactive pressure) and communicates with the control module (102) to regulate electrosurgical output [e.g., ¶[0034]].
Wham further teaches that sensor module (110) may include sensing elements placed at opposite surfaces of the tissue for generating a tissue thickness value pre-surgery, as well as during a surgical procedure [see ¶[0063] (“As described above, the sensor module 110 includes a proximity sensor having sensing elements placed at opposite surfaces of the tissue for sensing the distance between the sensing elements for sensing (e.g., measuring) tissue thickness at the surgical site "B", and generating a tissue thickness value. An initial tissue thickness value may be provided to the control module 102 as a pre-surgical parameter. Sensed real-time tissue thickness values and/or changes in tissue thickness values over time (Δ (difference) thickness/ Δ(difference) time) may further be provided to the control module 102 during the surgical procedure, where the control module 102 modulates the energy output in accordance with the sensed real-time tissue thickness values, changes in tissue thickness values, rate of change of tissue thickness over time and/or relative value of real-time measured tissue thickness values to the initial tissue thickness value”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pope to further include calculations of the thickness index value based on a temporal change during an electrosurgical sealing process (i.e., after application of the treatment energy has commenced), as taught by Wham, and to use such calculations in determining whether it is a change timing in Pope [e.g., whether the gradual voltage ramp for the RF energy should be terminated], since calculations of tissue thickness in real-time during a procedure can be used to, e.g., track the expected tissue behavior based on the selected template/profile of Pope with actual tissue behavior during the procedure, and modify RF energy delivery accordingly, thereby optimizing RF energy delivery during a procedure to improve outcomes.
B. CHANGING A GRASPING STATE & NOTIFIER
While Pope teaches determining a change timing to change a control state of the power source based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174]], the combination of Pope and Wham does not teach that the processor is configured to:
determine whether it is a change timing to change a grasping state of the biological tissue by the treatment tool based on the thickness index value, ... and
cause a notifier to notify information to prompt a change of the grasping state of the biological tissue upon determining that it is the change timing, the information being notified in response to the change timing being determined based on the temporal change of the thickness index value.
Kobayashi, in a similar field of endeavor, teaches an energy treatment instrument (2) and energy controller (3) [¶[0026]; FIG. 1]. The energy treatment instrument (2) comprises an end effector (6) configured such that a treatment target can be grasped between first and second grasping pieces (13, 14) thereof [¶’s [0027], [0029], [0030]].
Kobayashi further teaches that the energy controller (3) includes a processor (47) which includes a drive controller (52) [¶’s [0032]-[0033]]. The drive controller (52) determines a parameter regarding the grasping force applied to the treatment target grasped between the grasping pieces (13, 14) based on thickness of the target [¶’s [0033]-[0034]], and is further configured to control a grasping force adjustment unit (41) which can be actuated to adjust the grasping force applied between the grasping pieces (13, 14) [¶’s [0033]-[0034]] based on thickness.
Additionally, Kobayashi teaches causing a notifier to notify information to prompt a change of the grasping state of the biological tissue [e.g., ¶[0094] (“Note that, for example, the information regarding the wall thickness T of the blood vessel (information indicating whether the wall thickness T is larger than the predetermined thickness Tth and/or information indicating a type of the blood vessel) set by the setting unit 51 of the processor 47 can be notified to a surgeon by, e.g. a notification unit (not shown) provided in the energy controller 3 or the like. In this case, based on the notified information regarding the wall thickness T of the blood vessel, the surgeon manually operates the selection unit 44 (see FIG. 2) attached to, e.g. the housing 4 to adjust the actuation state of the grasping force adjustment unit 41. Accordingly, the grasping force exerted on the blood vessel between the grasping pieces 13 and 14 is adjusted”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pope and Wham such that the processor is further configured to determine whether it is a change timing to change a grasping state of the biological tissue by the treatment tool based on the thickness index value, and cause a notifier to notify information to prompt a change of the grasping state of the biological tissue upon determining that it is the change timing, since such a modification would improve sealing treatment and treatment performance by further enabling force control (as taught by Kobayashi [e.g., ¶’s [0097]-[0098]]) in addition to the energy control of Pope/Wham.
21. Regarding claim 12, Pope teaches a treatment system comprising:
a treatment tool [electrosurgical instrument (20) - ¶’s [0024], [0036]; FIG. 2]; and
a treatment tool generator [electrosurgical generator (10) - ¶’s [0024], [0025]; FIG. 1] configured to control an operation of the treatment tool [(20)] [¶’s [0025], [0036]], wherein
the treatment tool generator [(10)] includes:
a power source [as part of generator (10) - ¶’s [0026]-[0029]] configured to supply power to the treatment tool [(20)]; and
a processor [processor - e.g., ¶’s [0032], [0070], [0216]] configured to control an operation of the power source [(10)] [e.g., ¶’s [0032], [0070]],
the processor is configured to:
cause the power source [(10)] to supply the power to the treatment tool [(20)] to apply a treatment energy to a biological tissue from the treatment tool e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))],
calculate a thickness index value to be an index of a thickness dimension [tissue thickness] of the biological tissue that is grasped by the treatment tool [e.g., ¶’s [0151]-[0156]]...
determine whether it is a change timing [e.g., when a gradual voltage ramp for the RF energy should be terminated]... based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174] concerning windows of time used for determining maximum current peaks]…,
A. TEMPORAL CHANGE OF THICKNESS INDEX VALUE
While Pope teaches calculating the thickness of the tissue being sealed, Pope appears to do so in order to select RF energy levels based on a comparison with stored voltage profiles/templates used for tissues having similar thicknesses [e.g., ¶’s [0092]-[0095], [0151]-[0156]].
As such, Pope does not teach the following emphasized claim limitations:
calculate a thickness index value to be an index of a thickness dimension of the biological tissue that is grasped by the treatment tool, the thickness index value being calculated over time after the treatment energy is applied to the biological tissue,
determine whether it is a change timing... based on the thickness index value, the change timing being determined based on a temporal change of the thickness index value after the treatment energy is applied,
Wham, in a similar field of endeavor, teaches a system and method for controlling an electrosurgical generator that generates electrosurgical energy for delivery to a patient for sealing tissue during an electrosurgical procedure [e.g., Abstract].
More particularly, Wham teaches a closed loop control system (100) comprising, inter alia, a control module (102) and a sensor module (110). The control module (102) is operatively connected to an electrosurgical generator (101), and controls energy delivery by an electrosurgical instrument (e.g., an end-effector having jaws for grasping, dissecting and/or clamping tissue, such as for constricting vessels, and at least one delivery device for delivering surgical energy) to a patient [¶’s [0032]-[0033]].
The sensor module (110) senses various electrical and/or physical parameters or properties at the operating site (e.g., voltage, current, power and impedance across the tissue (tissue impedance), tissue temperature, leakage current, applied voltage, applied current, tissue thickness, volume of tissue between jaws of electrosurgical instrument, tissue light transmission, reflectivity and/or absorption properties, tissue moisture content level, tissue elastomeric properties, tissue viability and/or tissue reactive pressure) and communicates with the control module (102) to regulate electrosurgical output [e.g., ¶[0034]].
Wham further teaches that sensor module (110) may include sensing elements placed at opposite surfaces of the tissue for generating a tissue thickness value pre-surgery, as well as during a surgical procedure [see ¶[0063] (“As described above, the sensor module 110 includes a proximity sensor having sensing elements placed at opposite surfaces of the tissue for sensing the distance between the sensing elements for sensing (e.g., measuring) tissue thickness at the surgical site "B", and generating a tissue thickness value. An initial tissue thickness value may be provided to the control module 102 as a pre-surgical parameter. Sensed real-time tissue thickness values and/or changes in tissue thickness values over time (Δ (difference) thickness/ Δ(difference) time) may further be provided to the control module 102 during the surgical procedure, where the control module 102 modulates the energy output in accordance with the sensed real-time tissue thickness values, changes in tissue thickness values, rate of change of tissue thickness over time and/or relative value of real-time measured tissue thickness values to the initial tissue thickness value”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pope to further include calculations of the thickness index value based on a temporal change during an electrosurgical sealing process (i.e., after application of the treatment energy has commenced), as taught by Wham, and to use such calculations in determining whether it is a change timing in Pope [e.g., whether the gradual voltage ramp for the RF energy should be terminated], since calculations of tissue thickness in real-time during a procedure can be used to, e.g., track the expected tissue behavior based on the selected template/profile of Pope with actual tissue behavior during the procedure, and modify RF energy delivery accordingly, thereby optimizing RF energy delivery during a procedure to improve outcomes.
B. CHANGING A GRASPING STATE & NOTIFIER
While Pope teaches determining a change timing to change a control state of the power source based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174]], the combination of Pope and Wham does not teach that the processor is configured to:
determine whether it is a change timing to change a grasping state of the biological tissue by the treatment tool based on the thickness index value, ... and
cause a notifier to notify information to prompt a change of the grasping state of the biological tissue upon determining that it is the change timing, the information being notified in response to the change timing being determined based on the temporal change of the thickness index value.
Kobayashi, in a similar field of endeavor, teaches an energy treatment instrument (2) and energy controller (3) [¶[0026]; FIG. 1]. The energy treatment instrument (2) comprises an end effector (6) configured such that a treatment target can be grasped between first and second grasping pieces (13, 14) thereof [¶’s [0027], [0029], [0030]].
Kobayashi further teaches that the energy controller (3) includes a processor (47) which includes a drive controller (52) [¶’s [0032]-[0033]]. The drive controller (52) determines a parameter regarding the grasping force applied to the treatment target grasped between the grasping pieces (13, 14) based on thickness of the target [¶’s [0033]-[0034]], and is further configured to control a grasping force adjustment unit (41) which can be actuated to adjust the grasping force applied between the grasping pieces (13, 14) [¶’s [0033]-[0034]] based on thickness.
Additionally, Kobayashi teaches causing a notifier to notify information to prompt a change of the grasping state of the biological tissue [e.g., ¶[0094] (“Note that, for example, the information regarding the wall thickness T of the blood vessel (information indicating whether the wall thickness T is larger than the predetermined thickness Tth and/or information indicating a type of the blood vessel) set by the setting unit 51 of the processor 47 can be notified to a surgeon by, e.g. a notification unit (not shown) provided in the energy controller 3 or the like. In this case, based on the notified information regarding the wall thickness T of the blood vessel, the surgeon manually operates the selection unit 44 (see FIG. 2) attached to, e.g. the housing 4 to adjust the actuation state of the grasping force adjustment unit 41. Accordingly, the grasping force exerted on the blood vessel between the grasping pieces 13 and 14 is adjusted”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pope and Wham such that the processor is further configured to determine whether it is a change timing to change a grasping state of the biological tissue by the treatment tool based on the thickness index value, and cause a notifier to notify information to prompt a change of the grasping state of the biological tissue upon determining that it is the change timing, since such a modification would improve sealing treatment and treatment performance by further enabling force control (as taught by Kobayashi [e.g., ¶’s [0097]-[0098]]) in addition to the energy control of Pope/Wham.
22. Regarding claim 14, Pope teaches a treatment method of treating a biological tissue by a treatment tool grasping the biological tissue [e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))], the method comprising:
causing, by a processor [processor - e.g., ¶’s [0032], [0070], [0216]] of a treatment tool generator [electrosurgical generator (10) - ¶’s [0024], [0025]; FIG. 1], a power source [as part of generator (10) - ¶’s [0026]-[0029]] to supply power to a treatment tool [electrosurgical instrument (20) - ¶’s [0024], [0036]; FIG. 2] therefrom to apply a treatment energy to the biological tissue from the treatment tool [e.g., ¶’s [0025], [0036], & [0039] (tissue grasped between the jaws of jaw assembly (22) of electrosurgical instrument (20))];
calculating, by the processor, a thickness index value to be an index value of a thickness dimension [tissue thickness] of the biological tissue grasped by the treatment tool [e.g., ¶’s [0151]-[0156]]...;
determining, by the processor, whether it is a change timing [e.g., when a gradual voltage ramp for the RF energy should be terminated]... based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174] concerning windows of time used for determining maximum current peaks]…,
A. TEMPORAL CHANGE OF THICKNESS INDEX VALUE
While Pope teaches calculating the thickness of the tissue being sealed, Pope appears to do so in order to select RF energy levels based on a comparison with stored voltage profiles/templates used for tissues having similar thicknesses [e.g., ¶’s [0092]-[0095], [0151]-[0156]].
As such, Pope does not teach the following emphasized claim limitations:
calculating, by the processor, a thickness index value to be an index of a thickness dimension of the biological tissue that is grasped by the treatment tool, the thickness index value being calculated over time after the treatment energy is applied to the biological tissue,
determining, by the processor, whether it is a change timing... based on the thickness index value, the change timing being determined based on a temporal change of the thickness index value after the treatment energy is applied;
Wham, in a similar field of endeavor, teaches a system and method for controlling an electrosurgical generator that generates electrosurgical energy for delivery to a patient for sealing tissue during an electrosurgical procedure [e.g., Abstract].
More particularly, Wham teaches a closed loop control system (100) comprising, inter alia, a control module (102) and a sensor module (110). The control module (102) is operatively connected to an electrosurgical generator (101), and controls energy delivery by an electrosurgical instrument (e.g., an end-effector having jaws for grasping, dissecting and/or clamping tissue, such as for constricting vessels, and at least one delivery device for delivering surgical energy) to a patient [¶’s [0032]-[0033]].
The sensor module (110) senses various electrical and/or physical parameters or properties at the operating site (e.g., voltage, current, power and impedance across the tissue (tissue impedance), tissue temperature, leakage current, applied voltage, applied current, tissue thickness, volume of tissue between jaws of electrosurgical instrument, tissue light transmission, reflectivity and/or absorption properties, tissue moisture content level, tissue elastomeric properties, tissue viability and/or tissue reactive pressure) and communicates with the control module (102) to regulate electrosurgical output [e.g., ¶[0034]].
Wham further teaches that sensor module (110) may include sensing elements placed at opposite surfaces of the tissue for generating a tissue thickness value pre-surgery, as well as during a surgical procedure [see ¶[0063] (“As described above, the sensor module 110 includes a proximity sensor having sensing elements placed at opposite surfaces of the tissue for sensing the distance between the sensing elements for sensing (e.g., measuring) tissue thickness at the surgical site "B", and generating a tissue thickness value. An initial tissue thickness value may be provided to the control module 102 as a pre-surgical parameter. Sensed real-time tissue thickness values and/or changes in tissue thickness values over time (Δ (difference) thickness/ Δ(difference) time) may further be provided to the control module 102 during the surgical procedure, where the control module 102 modulates the energy output in accordance with the sensed real-time tissue thickness values, changes in tissue thickness values, rate of change of tissue thickness over time and/or relative value of real-time measured tissue thickness values to the initial tissue thickness value”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pope to further include calculations of the thickness index value based on a temporal change during an electrosurgical sealing process (i.e., after application of the treatment energy has commenced), as taught by Wham, and to use such calculations in determining whether it is a change timing in Pope [e.g., whether the gradual voltage ramp for the RF energy should be terminated], since calculations of tissue thickness in real-time during a procedure can be used to, e.g., track the expected tissue behavior based on the selected template/profile of Pope with actual tissue behavior during the procedure, and modify RF energy delivery accordingly, thereby optimizing RF energy delivery during a procedure to improve outcomes.
B. CHANGING A GRASPING STATE & NOTIFIER
While Pope teaches determining a change timing to change a control state of the power source based on the thickness index value [see ¶’s [0155], [0159]-[0162], note also ¶’s [0164]-[0174]], the combination of Pope and Wham does not teach that the processor is configured to:
determining, by the processor, whether it is a change timing to change a grasping state of the biological tissue by the treatment tool based on the thickness index value, ... and
causing, by the processor, a notifier to notify information to prompt a change of the grasping state of the biological tissue upon determining that it is the changing timing, the information being notified in response to the change timing being determined based on the temporal change of the thickness index value.
Kobayashi, in a similar field of endeavor, teaches an energy treatment instrument (2) and energy controller (3) [¶[0026]; FIG. 1]. The energy treatment instrument (2) comprises an end effector (6) configured such that a treatment target can be grasped between first and second grasping pieces (13, 14) thereof [¶’s [0027], [0029], [0030]].
Kobayashi further teaches that the energy controller (3) includes a processor (47) which includes a drive controller (52) [¶’s [0032]-[0033]]. The drive controller (52) determines a parameter regarding the grasping force applied to the treatment target grasped between the grasping pieces (13, 14) based on thickness of the target [¶’s [0033]-[0034]], and is further configured to control a grasping force adjustment unit (41) which can be actuated to adjust the grasping force applied between the grasping pieces (13, 14) [¶’s [0033]-[0034]] based on thickness.
Additionally, Kobayashi teaches causing a notifier to notify information to prompt a change of the grasping state of the biological tissue [e.g., ¶[0094] (“Note that, for example, the information regarding the wall thickness T of the blood vessel (information indicating whether the wall thickness T is larger than the predetermined thickness Tth and/or information indicating a type of the blood vessel) set by the setting unit 51 of the processor 47 can be notified to a surgeon by, e.g. a notification unit (not shown) provided in the energy controller 3 or the like. In this case, based on the notified information regarding the wall thickness T of the blood vessel, the surgeon manually operates the selection unit 44 (see FIG. 2) attached to, e.g. the housing 4 to adjust the actuation state of the grasping force adjustment unit 41. Accordingly, the grasping force exerted on the blood vessel between the grasping pieces 13 and 14 is adjusted”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pope and Wham to include determining, by the processor, whether it is a change timing to change a grasping state of the biological tissue by the treatment tool based on the thickness index value, and causing, by the processor, a notifier to notify information to prompt a change of the grasping state of the biological tissue upon determining that it is the changing timing, since such a modification would improve sealing treatment and treatment performance by further enabling force control (as taught by Kobayashi [e.g., ¶’s [0097]-[0098]]) in addition to the energy control of Pope/Wham.
23. Regarding claim 15, the combination of Pope, Wham, & Kobayashi teaches all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Kobayashi further teaches changing, by an operator operating the treatment tool changes, a grasping force of the biological tissue by the treatment tool upon recognizing the information [¶[0094]].
24. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pope and Wham, as applied to claim 1 above, and further in view of U.S. 2024/0122638 to Zhao et al. ("Zhao") [NOTE: the portion of Zhao relied-upon in the rejection is fully supported by the 03/03/2021 Priority Application (U.S. 63/155,801)].
25. Regarding claim 6, the combination of Pope and Wham teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Pope and Wham, however, does not teach:
wherein the processor is configured to acquire, from an endoscope device configured to generate an endoscopic image capturing a state in which the biological tissue is grasped by the treatment tool, the endoscopic image, and calculate the thickness index value based on the endoscopic image.
Zhao, in a similar field of endeavor, teaches that it was known in the art to utilize an endoscopic image --capturing a state in which biological tissue is grasped by a treatment tool-- to determine tissue thickness [see ¶[0018] (“In accordance with aspects of the disclosure, a computer-implemented method for controlling an energy generator includes capturing image data of a surgical site and an electrosurgical instrument through an endoscope, the electrosurgical instrument including a pair of jaws, determining a thickness of tissue grasped by the pair of jaws based on the image, outputting radio frequency (RF) energy to the electrosurgical instrument from an energy generator, and controlling RF energy based on the determined thickness”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pope and Wham such that the processor is configured to acquire, from an endoscope device configured to generate an endoscopic image capturing a state in which the biological tissue is grasped by the treatment tool, the endoscopic image, and calculate the thickness index value based on the endoscopic image, since such a particular, known tissue thickness determination technique was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Zhao, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Pope, and the results (tissue thickness determination) would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
26. As noted above, the 06/15/26 Amendment has overcome the claim rejections under §§ 112(b), 102, & 103 previously set forth in the 03/19/26 Action.
27. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Citation of Pertinent Prior Art
28. U.S. 2008/0039836 to Odom et al. (“Odom”) provides additional context concerning the known effects of the tissue sealing process on tissue thickness:
¶[0021] (“In particular, the RF output applied to tissue grasped between opposing jaw members of a forceps instrument is controlled based on sensed feedback measurements of a gap distance "G" between the opposing jaw members. It has been observed that the relative thickness of various tissues decreases precipitously during the initial stages of a sealing process. In particular, it has been determined that tissue thickness decreases due to cell ruptures caused by constant application of energy and pressure. Since tissue thickness directly corresponds to the gap distance "G" between opposing jaw members, it is envisioned that adjusting RF output based on the desired rate of change of the gap distance "G" controls the decrease in the tissue thickness during the sealing process resulting in a confident, more reliable tissue seal…”);
¶[0043] (“The gap distance "G" is directly related to the thickness of tissue being grasped between the sealing plates 112 and 122… … thickness of the tissue and therefore the gap distance "G" decrease, as pressure and energy are applied thereto. Tissue thickness decreases for at least two reasons. First, the pressure applied to the tissue by the sealing plates 112 and 122 compresses tissue. Second, RF energy applied to the tissue increases the temperature therein at which point intra-cellular fluids being to boil thereby causing the cells to rupture uncontrollably”)]; &
¶[0046] (“When the sealing plates 112 and 122 contact the tissue 400 electrosurgical energy is applied thereto and the collagen contained therein is denatured and becomes more mobile (i.e., liquefies)”).
Conclusion
29. Applicant's amendment necessitated the new ground(s) of rejection presented in this
Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is
reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
30. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617. The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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