DETAILED ACTION
This action is in response to applicant's amendments filed 12/17/25.
The examiner acknowledges the amendments to the claims.
Claims 57-64, 66-73, 75-76 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species 2 (processor configured to identify a property based on the measured voltage, the measured current, and a no load resistance of the ultrasonic handpiece) in the reply filed on 12/17/25 is acknowledged.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 57, 66, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Downey et al., hereinafter “Downey” (U.S. Pub. No. 2018/0263652) in view of Lorang et al., hereinafter “Lorang” (U.S. Pub. No. 2006/0293649).
Regarding claim 57, Downey discloses an ultrasonic tool system 30 (Figure 1) for probing patient tissue (see abstract), the system comprising:
an ultrasonic handpiece 32 (Figure 2) comprising a tip 52 having a distal region for treating patient tissue and at least one driver 40 ([0038]) to which the tip is coupled and to which an AC drive signal is applied to vibrate the tip ([0003], [0049]), the ultrasonic handpiece defining a first pathway for providing suction ([0045]) at the distal region of the tip and a second pathway for supplying fluid ([0044]) to the distal region of the tip; and
a control console 64 (Figure 3; [0047]) coupled to the ultrasonic handpiece and configured to generate the AC drive signal applied to the at least one driver of the ultrasonic handpiece for vibrating the tip of the ultrasonic handpiece ([0003]), the control console comprising:
a first sensor (Figure 3, [0050]; tickler coil 80 and voltage measuring circuit 86) for measuring a voltage of the AC drive signal;
a second sensor (Id.; coil 90 and current measuring circuit 92) for measuring a current of the AC drive signal; and
a processor 96 coupled to the first and second sensors and configured to:
source the AC drive signal to the at least one driver of the ultrasonic handpiece ([0052]-[0054]), the AC drive signal inducing vibrations at the distal region of the tip ([0003]);
measure the voltage and current of the AC drive signal using the first and second sensors ([0051]).
However, Downey does not disclose the AC drive signal inducing vibrations at the distal region of the tip that are insufficient to ablate the patient tissue, although Downey teaches in [0054] a switch 106 monitored by processor 96 to control the magnitude of the vibrations at the tip, including an initial vibration cycle of small amplitude before undergoing a larger magnitude vibration cycle. Downey also does not disclose that the processor is configured to provide at least one of an audible, visual, or tactile indication based on the measured voltage and current.
Lorang teaches a tool system (Figure 1A) for probing patient tissue including a processor ([0016], [0017], [0097]; generator 100 includes a control module) configured to source a signal inducing energy to a tip of a probe insufficient to ablate the patient tissue ([0047]; the generator switches to delivering power to a “non-ablative mode”) to limit the amount of power delivered to the tissue. Furthermore, in [0096], Lorang teaches the system providing an audible alarm or visual indication based on a measured voltage and current such that the operator can be warned if the measured amount is above a threshold and to act accordingly.
It would have been obvious to one of ordinary skill before the effective filing date to modify Downey such that the vibrations induced are insufficient to ablate tissue as claimed, and to provide at least one of an audible, visual, or tactile indication as claimed, as taught by Lorang, in order to limit power to a patient’s tissue and prevent undesirable surgical outcomes (Lorang, [0003]), and to warn an operator of undesirable parameters regarding voltage or current (Lorang, [0096]).
Regarding claim 66, Downey discloses a method for probing patient tissue using ultrasonic tool system 30 (Figure 1; see abstract) including an ultrasonic handpiece 32 (Figure 2) having a tip 52 for treating patient tissue and at least one driver 40 ([0038]) to which the tip is coupled and to which an AC drive signal is applied to vibrate the tip ([0003], [0049]), the method comprising:
supplying fluid to a distal region of the tip through at least a portion of the ultrasonic handpiece ([0044]);
providing suction at the distal region of the tip through at least a portion of the ultrasonic handpiece ([0045]);
sourcing the AC drive signal to the ultrasonic handpiece ([0052]-[0054]), the AC drive signal inducing vibrations at the distal region of the tip ([0003], [0049]); and
measuring a voltage and a current of the AC drive signal ([0051]).
However, Downey does not disclose the AC drive signal inducing vibrations at the distal region of the tip that are insufficient to ablate the patient tissue, although Downey teaches in [0054] a switch 106 monitored by processor 96 to control the magnitude of the vibrations at the tip, including an initial vibration cycle of small amplitude before undergoing a larger magnitude vibration cycle. Downey also does not disclose providing at least one of an audible, visual, or tactile indication based on the measured voltage and current.
Lorang teaches a tool system (Figure 1A) for probing patient tissue including a processor ([0016], [0017], [0097]; generator 100 includes a control module) sourcing a signal inducing energy to a tip of a probe insufficient to ablate the patient tissue ([0047]; the generator switches to delivering power to a “non-ablative mode”) to limit the amount of power delivered to the tissue. Furthermore, in [0096], Lorang teaches the system providing an audible alarm or visual indication based on a measured voltage and current such that the operator can be warned if the measured amount is above a threshold and to act accordingly.
It would have been obvious to one of ordinary skill before the effective filing date to modify Downey such that the vibrations induced are insufficient to ablate tissue as claimed, and to provide at least one of an audible, visual, or tactile indication as claimed, as taught by Lorang, in order to limit power to a patient’s tissue and prevent undesirable surgical outcomes (Lorang, [0003]), and to warn an operator of undesirable parameters regarding voltage or current (Lorang, [0096]).
Regarding claim 75, Downey discloses an ultrasonic tool system 30 (Figure 1; see abstract) comprising:
an ultrasonic handpiece 32 (Figure 2) comprising a tip 52 having a distal region for treating patient tissue and at least one driver 40 ([0038]) to which the tip is coupled and to which an AC drive signal is applied to vibrate the tip ([0003], [0049]), the ultrasonic handpiece defining a first pathway for providing suction at the distal region of the tip ([0045]) and a second pathway for supplying fluid to the distal region of the tip ([0044]);
a control console 64 (Figure 3; [0047]) coupled to the ultrasonic handpiece and configured to generate the AC drive signal applied to the at least one driver of the ultrasonic handpiece for vibrating the tip of the ultrasonic handpiece ([0003]); and
a switch 106 ([0054]) communicatively coupled to the control console, the switch having a first setting and a second setting, (Id.; switch 106 controls the magnitude of the vibrations at the tip, including a first initial vibration cycle of small amplitude before undergoing a second larger magnitude vibration cycle),
wherein responsive to the switch being set to the first setting, the control console is configured to operate the ultrasonic handpiece in one mode (having a small amplitude vibration cycle; Id.), and responsive to the switch being set to the second setting, the control console is configured to operate the ultrasonic handpiece in an ablation mode (having a larger magnitude vibration cycle; Id.).
However, Downey does not expressly teach the first setting being a probing mode.
Lorang teaches a tool system (Figure 1A) for probing patient tissue including a switch having a first probing mode and a second ablative mode ([0047], [0048], [0058]; the generator switches to delivering power from a probing or “ablative mode” to a “non-ablative mode”) to limit the amount of power delivered to the tissue.
It would have been obvious to one of ordinary skill before the effective filing date to modify Downey such that the first setting is a probing mode, as taught by Lorang, in order to allow the operator to switch to limiting power to a patient’s tissue and prevent undesirable surgical outcomes (Lorang, [0003]).
Claims 58 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Downey (U.S. Pub. No. 2018/0263652) in view of Lorang (U.S. Pub. No. 2006/0293649), as applied to claims 57 and 66 above, and further in view of Biscup (U.S. Pub. No. 2004/0034340).
Regarding claims 58 and 67, Downey as modified teaches the claimed invention, as discussed above, including wherein the processor is configured to provide at least one of an audible, visual, or tactile indication based on the measured voltage and current, except for the processor identifying a property of the patient tissue based on the measured voltage and current; and providing at least one of an audible, visual, or tactile indication of the identified property.
Biscup teaches an ultrasonic tool system 10 (Figure 1, [0036]) including a processor 60 ([0039]) that is configured to identify a property of the patient tissue based on measured parameters by sensors ([0017]) and providing at least one of an audible, visual, or tactile indication of the identified property ([0041], [0046]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Downey as modified to have the processor configured to provide at least one of an audible, visual, or tactile indication based on the measured voltage and current, and configured to provide at least one of an audible, visual, or tactile indication of the identified property, as taught by Biscup, in order to distinguish between different types of tissues such that removal of non-targeted tissue is prevented, and therefore spare good tissue and remove unwanted tissue (Biscup; [0017]).
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Downey (U.S. Pub. No. 2018/0263652) in view of Lorang (U.S. Pub. No. 2006/0293649), as applied to claim 75 above, and further in view of Woloszko et al., hereinafter “Woloszko” (U.S. Pub. No. 2020/0397500).
Regarding claim 76, Downey as modified teaches the claimed invention, as discussed above, including the control console 96 being configured to operate the ultrasonic handpiece in the ablation mode by being configured to source a first AC drive signal to the ultrasonic handpiece that induces first vibrations in the tip of a first magnitude (Downey; [0052]-[0054]), provide the suction at the distal region of the tip through the first pathway defined by the ultrasonic handpiece (Downey; [0045]), and supply the fluid to the distal region of the tip through the second pathway defined by the tip (Downey; [0044]), wherein the control console is configured to operate the ultrasonic handpiece in the probing mode (non-ablative mode; Lorang, ([0047], [0048], [0058]) by being configured to source a second AC drive signal to the ultrasonic handpiece that induces second vibrations in the tip of a second magnitude that is less than the first magnitude (Downey; [0054]).
However, Downey as modified does not disclose that the control console is configured to operate the ultrasonic handpiece in the probing mode without providing the suction at the distal region of the tip through the first pathway defined by the ultrasonic handpiece and supplying the fluid to the distal region of the tip through the second pathway defined by the tip.
In [0097], [0103], [0113], Woloszko teaches a control console (controller) can control the rate of providing suction (aspiration) and supplying fluid depending on the mode setting (a probing, or no ablation coagulation mode in [0099], or ablation mode in [0102]). The “mode selection may also alter the irrigation or aspiration level to and from the tissue” ([0103]), wherein supplying of fluid is low in the probing mode (Woloszko, [0099], [0113]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Downey as modified to operate in the probing mode with supplying fluid to the distal region of the tip and controlling the amount of suction at the distal region of the tip, as taught by Woloszko, in order to adjust to the different tissues or environments in which the tip is located, which may ease startup, provide less thermal effect or hot spots ([0113]). Although Woloszko does not expressly teach not providing suction in the probing mode, since the supplying of fluid is low in the probing mode (Woloszko, [0099]), a skilled artisan would find it obvious to not provide suction in the probing mode considering there is less excess fluid and no products of ablation to be aspirated.
Allowable Subject Matter
Claims 59-64, 68-73 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious an ultrasonic tool system and method for probing patient tissue including, inter alia, an ultrasonic handpiece having a tip for treating patient tissue, wherein an AC drive signal is applied to vibrate the tip, wherein the AC drive signal can induce vibrations at the distal region of the tip that are insufficient to ablate the patient’s tissue, a voltage and current of the AC drive signal are measured, and at least one of an audible, visual, or tactile indication is provided based on the measured voltage and current, wherein
a property of the patient tissue is identified based on the measured voltage, the measured current, and a no load resistance of the ultrasonic handpiece. The prior art of record, as discussed above, teaches the claimed invention, except is silent with regards to measuring a no load resistance, or a resistance of the ultrasonic handpiece when it is unloaded or is not in contact with any tissue in order to identify a property of the patient tissue, in addition to measuring the voltage and current of the AC drive signal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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