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 .
Status of Claims
2. Claims 1-15 as originally filed on 11/01/2023 are pending, and have been examined on the merits.
Claim Rejections - 35 USC § 112
3. 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.
4. Claim 5 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
5. Claim 5 recites the limitation “when a change rate of the thickness index value becomes lower than a second threshold” in lines 4-6. This recitation renders the claim indefinite, as neither claim 5 nor independent claim 1 (from which claim 5 depends) recites “a first threshold.” As such, it is not clear how many “thresholds” are required by the claim. Clarification is required.
Claim Rejections - 35 USC § 102
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 1, 2, 4, 5, 7-9, 11, & 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2021/0196368 to Pope et al. (“Pope”).
8. Regarding claim 1, Pope discloses 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 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 of 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]], the second control of increasing a grasping force to grasp the biological tissue by the treatment tool, the third control of decreasing the grasping force to grasp the biological tissue by the treatment tool for a predetermined time period.
9. Regarding claim 2, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further discloses 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, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further discloses 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, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejection under § 112(b) above], Pope further discloses 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 second threshold [e.g., ¶[0170]].
12. Regarding claim 7, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further discloses 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, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further discloses 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, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope further discloses 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].
15. Regarding claim 11, Pope discloses 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 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 of 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]], the second control of increasing a grasping force to grasp the biological tissue by the treatment tool, the third control of decreasing the grasping force to grasp the biological tissue by the treatment tool for a predetermined time period.
16. Regarding claim 13, Pope discloses a control method that is 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 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 of 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]], the second control of increasing a grasping force to grasp the biological tissue by the treatment tool, the third control of decreasing the grasping force to grasp the biological tissue by the treatment tool for a predetermined time period.
Claim Rejections - 35 USC § 103
17. 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.
18. 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.
19. Claims 3, 10, 12, 14, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of U.S. Patent Application Publication No. 2019/0021757 to Kobayashi et al. ("Kobayashi").
20. Regarding claim 3, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope does not, however, disclose:
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 modify Pope such that 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.
21. 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 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]],
Changing a Grasping State
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]], Pope 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.
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 modify Pope 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.
22. 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 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]].
Changing a Grasping State
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]], Pope 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.
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 modify Pope 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.
23. 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 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]].
Changing a Grasping State
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]], Pope does not teach:
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.
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 modify Pope 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.
24. Regarding claim 15, the combination of Pope and 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]].
25. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Pope in view of U.S. Patent Application Publication No. 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)].
26. Regarding claim 6, Pope discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Pope does not, however, disclose:
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 modify Pope 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).
Conclusion
27. 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 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. 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/Examiner, Art Unit 3794