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 .
Response to Amendment
Examiner acknowledges the amendments made to claims 1 and 15. Claims 1-21 remain pending in the present application and the following is the office action pursuant to the examiner interview with applicant held on 12/04/2025.
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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hase (US Patent No 20210346085) in view of Yamada (US Patent No 20150119761) further in view of Mei (US Patent No 20220013948). Examiner understands that both the prior arts of record have a later filing date than the present application, however both references of prior art have an earlier priority date publication than the present application, thereby qualifying Hase and Mei as prior art of record.
Regarding claim 1, Hase teaches an energy device (treatment system 1, [0036]), comprising: a piezoelectric material having a cylindrical shape (piezoelectric devices 543 having a substantially cylindrical shape, [0112]), the piezoelectric material including a first surface and a second surface opposing to the first surface (see fig 4 for devices 543 in which the first side is depicted as the proximal side of the device and the second surface is the distal side of the device 543), the piezoelectric material configured to generate an ultrasonic vibration for treating living tissue by an ultrasonic energy (piezoelectric devices 543 generates axial ultrasound vibrations for treatment, [0121]); a first electrode contacting the first surface of the piezoelectric material (see fig 4 for first electrode 541 contacting the first surface of 543), the first electrode configured to apply an ultrasonic driving voltage to the piezoelectric material for generating the ultrasonic vibration (where first electrode 541 is used with a driving signal to power and generate the ultrasonic vibrations, [0099]); a second electrode contacting the second surface of the piezoelectric material (see fig 4 for second electrode 542 contacting the second surface of 543), the second electrode configured to apply a reference voltage to the piezoelectric material for generating the ultrasonic vibration (electrode plate 542 is a positive electrode plate for generating and powering ultrasonic vibration, [0104]; an electrical insulated plate having an electrical insulating property (insulating plate 544, [0112]); a third electrode (see in figure 4 wherein there are multiple different electrode plates 541a, in which one of the electrode plates 541a is opposed to the second electrode 542 with insulating elements 544 interposed, thereby equating to the third electrode) the third electrode configured to apply a high-frequency electric power for treating living tissue by a high-frequency energy (in which the driving signal is applied between the electrode plates 541 and 542 to allow for the output of ultrasound and high frequency energy, [0121], and therefore as the third electrode is classified as an electrode plate 541a).
Hase does not explicitly teach wherein the second electrode is located between the electrical insulated plate and the piezoelectric material, wherein the electrical insulated plate contacts the second electrode, and wherein the electrical insulated plate is located between the third electrode and the second electrode.
However, the analogous ultrasonic transmission treatment device which is taught by Yamada does disclose a second electrode which is located between the electrical insulated plate and the piezoelectric material, wherein the electrical insulated plate contacts the second electrode, and wherein the electrical insulated plate is located between the third electrode and the second electrode (see further disclosure from Yamada [0039]-[0040], see also the Yamada annotated figure 3 below for further detail on how the 2nd and 3rd electrode are aligned with the insulated member and piezoelectric material).
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Yamada Annotated Figure 3.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the energy delivery device disclosed by Hase, to have the specific electrode, piezoelectric member and insulating member configuration taught by Yamada as it is another known ultrasonic transducer configuration known in the art and it allows for effective ultrasonic wave generation as disclosed by Yamada, [0040].
Hase nor Yamada explicitly state the device containing a short-circuit prevention portion configured to prevent a short-circuit between the first electrode and the third electrode.
However, the analogous ultrasonic energy delivery device disclosed by Mei does teach a short-circuit prevention portion configured to prevent a short-circuit between the first electrode and the third electrode (see fig 49 in which the ultrasonic device contains the piezoelectric array 4201 with electrode sheet 4227 seen as the first electrode and electrode sheet 4237 seen as the third electrode. In which there is an insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]).
Therefore, it would have been obvious to use the energy delivery device taught by Hase and Yamada in combination with the specific short circuit prevention configuration taught by Mei to effectively produce HF and ultrasonic energy without resulting in a shorting circuit device, as disclosed by Mei, [0254].
Regarding claim 2, the combination teaches the energy device according to claim 1, wherein the short-circuit prevention portion is configured to prevent the short-circuit between the first electrode and the third electrode from occurring (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) on an outer peripheral surface side of the piezoelectric material (Mei, insulation sleeve 500 arranged on the outer peripheral face, [0258]).
Regarding claim 3, the combination teaches the energy device according to claim 1, wherein the short-circuit prevention portion is configured to prevent the short-circuit between the first electrode and the third electrode (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) from occurring on an inner peripheral surface side of the piezoelectric material (Mei, see fig 49 depicting the insulating sleeve 500 found on the inner surface of the piezoelectric array 4201, see also [0258]).
Regarding claim 4, the combination teaches the energy device according to claim 1, wherein the short-circuit prevention portion is the second electrode and a portion of the second electrode intersects an imaginary straight line, where the imaginary straight line is an imaginary straight line without a circumferential component between an outermost side of the third electrode and the first electrode (see the Mei annotated figure 49 for explanation on how claim limitation is being interpreted and taught by Mei fig 49. Based on the following interpretation of the “imaginary line” the second electrode 4217 intersects the line between the first 4227 and third electrode 4237).
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Annotated figure 49 from Mei.
Regarding claim 5, the combination teaches the energy device according to claim 4, wherein the imaginary straight line without circumferential component is the shortest imaginary straight line without circumferential component between the outermost side of the third electrode and any location on the first electrode not covered by an insulating tube (according to the annotated figure 49 above from Mei and this broadest reasonable interpretation of the “imaginary line” is the shortest straight line between the first and third electrodes 4227 and 4237).
Regarding claim 6, the combination teaches the energy device according to claim 4, wherein the imaginary straight line without circumferential component is one of: (i) the shortest imaginary straight line without circumferential component having a first end at any location within a bend in the first electrode where a positive electrode plate portion of the first electrode transitions to become a positive electrode terminal portion of the first electrode and a second end at the outermost side of the third electrode; (ii) the shortest imaginary straight line without circumferential component between the outermost side of the third electrode and any location on a positive electrode plate portion of the first electrode not covered by an insulating tube, and (iii) the shortest imaginary straight line without circumferential component between the outermost side of the third electrode and any location on a positive electrode terminal portion of the first electrode not covered by an insulating tube (according to the annotated figure 49 above from Mei and this broadest reasonable interpretation of the “imaginary line” is the shortest straight line between the outermost side of third electrode 4237 and the positive electrode plate portion of the first electrode 4227 which is not covered by the insulated sleeve 500, thereby teaching one of the following components).
Regarding claim 7, the combination teaches the energy device according to claim 4, wherein the portion of the second electrode extends in a radial direction beyond the third electrode (see from Hase wherein the diameter size of the electrode plate components and therefore also the radial direction, increases between the distal side Ar1 and the proximal side Ar2, [0112] resulting in the second electrode extending radially beyond the third electrode).
Regarding claim 8, the combination teaches the energy device according to claim 7, wherein the first electrode has a protrusion that extends in the radial direction (Hase discloses the first electrode containing a protrusion extending in a radial direction, see first electrode terminal 541c extending from an outer edge in a radial direction, fig 4, [0103]), and wherein at least a portion of the short-circuit prevention portion is located at a position in a circumferential direction around a central axis of the piezoelectric material that is the same as a position of the protrusion of the first electrode (see fig 49 of Mei which teaches the insulated sleeve 500 for short circuit prevention which is shown to be in the same circumferential position of the first electrode 4227).
Regarding claim 9, the combination teaches the energy device according to claim 7, wherein the short-circuit prevention portion has a protruded part that is bent to extend along a central axis of the piezoelectric material (see Mei fig 49 in which the insulated sleeve 500 is extended along the whole central axis of the piezo array 4201).
Regarding claim 10, the combination teaches the energy device according to claim 1, wherein the short-circuit prevention portion is a structure including an electrical insulated material (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]).
Regarding claim 11, the combination teaches the energy device according to claim 10, wherein the first electrode has a protrusion that extends in a radial direction of the piezoelectric material (Hase discloses the first electrode containing a protrusion extending in a radial direction, see first electrode terminal 541c extending from an outer edge in a radial direction, fig 4, [0103]), and wherein a portion of the short-circuit prevention portion is located at position in a circumferential direction around a central axis of the piezoelectric material that is different than a position of the protrusion of the first electrode (see Mei fig 49 in which the insulated sleeve 500 is extended along the whole central axis of the piezo array 4201, therefore extending in directions differently than the first electrode 4227 and thereby having a different position than the first electrode protrusion).
Regarding claim 12, the combination teaches the energy device according to claim 10, wherein the short-circuit prevention portion is a portion of the electrical insulated plate (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) and the portion of the electrical insulated plate extends in a radial direction beyond the third electrode (see Mei fig 49 which depicts the insulating sleeve 500 extending radially past the third electrode 4237).
Regarding claim 13, the combination teaches the energy device according to claim 10, wherein the short-circuit prevention portion is an electrical insulated tube (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) disposed to cover an outer peripheral surface of the third electrode (Mei, insulation sleeve 500 arranged on the outer peripheral face, [0258]).
Regarding claim 14, the combination teaches the energy device according to claim 10, wherein the short-circuit prevention portion is an insulated tube (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) disposed to cover an inner peripheral surface of the third electrode (Mei, insulation sleeve 500 arranged on the inner peripheral face, [0258]).
Regarding claim 15, Hase teaches a treatment instrument (treatment system 1, [0036]), comprising: an end effector (probe 12, [0041]) configured to apply an ultrasonic energy and a high- frequency energy to living tissue for treating living tissue (used for applying high frequency energy and ultrasound energy to the treatment target, [abstract]); and an ultrasonic transducer configured to generate the ultrasonic vibration for treating living tissue by an ultrasonic energy (ultrasonic transducer 5, [0039]), the ultrasonic transducer comprising: a piezoelectric material having a cylindrical shape (piezoelectric devices 543 having a substantially cylindrical shape, [0112]), the piezoelectric material including a first surface and a second surface opposing to the first surface (see fig 4 for devices 543 in which the first side is depicted as the proximal side of the device and the second surface is the distal side of the device 543), the piezoelectric material configured to generate an ultrasonic vibration for treating living tissue by the ultrasonic energy (piezoelectric devices 543 generates axial ultrasound vibrations for treatment, [0121]), a first electrode contacting the first surface of the piezoelectric material (see fig 4 for first electrode 541 contacting the first surface of 543), the first electrode configured to apply an ultrasonic driving voltage to the piezoelectric material for generating the ultrasonic vibration (where first electrode 541 is used with a driving signal to power and generate the ultrasonic vibrations, [0099]), a second electrode contacting the second surface of the piezoelectric material (see fig 4 for second electrode 542 contacting the second surface of 543), the second electrode configured to apply a reference voltage to the piezoelectric material for generating the ultrasonic vibration (electrode plate 542 is a positive electrode plate for generating and powering ultrasonic vibration, [0104]), an electrical insulated plate having an electrical insulating property (insulating plate 544, [0112]), a third electrode (see in figure 4 wherein there are multiple different electrode plates 541a, in which one of the electrode plates 541a is opposed to the second electrode 542 with insulating elements 544 interposed, thereby equating to the third electrode) the third electrode configured to apply a high-frequency electric power for treating living tissue by a high-frequency energy (in which the driving signal is applied between the electrode plates 541 and 542 to allow for the output of ultrasound and high frequency energy, [0121], and therefore as the third electrode is classified as an electrode plate 541a).
Hase does not explicitly teach wherein the second electrode is located between the electrical insulated plate and the piezoelectric material, wherein the electrical insulated plate contacts the second electrode, and wherein the electrical insulated plate is located between the third electrode and the second electrode.
However, the analogous ultrasonic transmission treatment device which is taught by Yamada does disclose a second electrode which is located between the electrical insulated plate and the piezoelectric material, wherein the electrical insulated plate contacts the second electrode, and wherein the electrical insulated plate is located between the third electrode and the second electrode (see further disclosure from Yamada [0039]-[0040], see also the Yamada annotated figure 3 below for further detail on how the 2nd and 3rd electrode are aligned with the insulated member and piezoelectric material).
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Yamada Annotated Figure 3.
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the energy delivery device disclosed by Hase, to have the specific electrode, piezoelectric member and insulating member configuration taught by Yamada as it is another known ultrasonic transducer configuration known in the art and it allows for effective ultrasonic wave generation as disclosed by Yamada, [0040].
Hase nor Yamada explicitly state the device containing a short-circuit prevention portion configured to prevent a short-circuit between the first electrode and the third electrode.
However, the analogous ultrasonic energy delivery device disclosed by Mei does teach a short-circuit prevention portion configured to prevent a short-circuit between the first electrode and the third electrode (see fig 49 in which the ultrasonic device contains the piezoelectric array 4201 with electrode sheet 4227 seen as the first electrode and electrode sheet 4237 seen as the third electrode. In which there is an insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]).
Therefore, it would have been obvious to use the energy delivery device taught by Hase and Yamada in combination with the specific short circuit prevention configuration taught by Mei to effectively produce HF and ultrasonic energy without resulting in a shorting circuit device, as disclosed by Mei, [0254].
Regarding claim 16, the combination teaches the treatment instrument according to claim 15, further comprising, a power transmission member configured to transmit the ultrasonic vibration generated by the ultrasonic transducer from a proximal part to a distal part (from Hase, the ultrasound vibrator component 53 acts as the power transmission member in this instance, [0097]), wherein the end effector is a part of a distal side of the power transmission member (see Hase fig 4 depicting the probe 12 as the distal end connected to the ultrasound vibrator component 53), wherein the ultrasonic transducer includes: a front mass (from Hase, front mass 55) connected mechanically to a proximal side of the power transmission member (see fig 4 of Hase depicting the front mass connected proximally to the ultrasound vibrator component 53), and a back mass electrically connecting to the front mass, the back mass attaching the piezoelectric material, the first electrode, the second electrode, the insulation plate, and the third electrode to the ultrasonic transducer (Hase, see back mass 56 which connects to the array of electrodes 542 and 541 including the piezoelectric material 543 and the insulation plate 544, [0106], see also fig 4) and wherein the end effector is configured to be supplied with the high-frequency electric power via the third electrode, the back mass, the front mass, and the power transmission member (Hase, wherein back mass 56 is electrically connected to the HF electrode terminal 521 through an electrical pathway to deliver HF energy, [0114]).
Regarding claim 17, the combination teaches the treatment instrument according to claim 15, wherein the short-circuit prevention portion is configured to prevent the short-circuit between the first electrode and the third electrode (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) from occurring on an outer peripheral surface side of the piezoelectric material (Mei, insulation sleeve 500 arranged on the outer peripheral face, [0258]).
Regarding claim 18, the combination teaches the treatment instrument according to claim 15, wherein the short-circuit prevention portion is configured to prevent the short-circuit between the first electrode and the third electrode (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]) from occurring on an inner peripheral surface side of the piezoelectric material (Mei, see fig 49 depicting the insulating sleeve 500 found on the inner surface of the piezoelectric array 4201, see also [0258]).
Regarding claim 19, the combination teaches the treatment instrument according to claim 15, wherein the short-circuit prevention portion is the second electrode and a portion of the second electrode intersects an imaginary straight line, where the imaginary straight line is an imaginary straight line between the third electrode and the first electrode having an axial component of the piezoelectric material and without a circumferential component (see the Mei annotated figure 49 above for explanation on how claim limitation is being interpreted and taught by Mei fig 49. Based on the following interpretation of the “imaginary line” the second electrode 4217 intersects the line between the first 4227 and third electrode 4237).
Regarding claim 20, the combination teaches the treatment instrument according to claim 19, wherein the portion of the second electrode extends in a radial direction beyond the third electrode (see Hase fig 3 which depicts the electrode terminal 522 corresponding to the second electrode extending in a radial direction further than electrode terminal 521 corresponding to the third electrode).
Regarding claim 21, the combination teaches the treatment instrument according to claim 15, wherein the short-circuit prevention portion is a structure including an electrical insulated material (Mei, insulating sleeve 500 that is used to isolate the individual components of the piezoelectric assembly in order to prevent short circuits, [0254]).
Response to Arguments
Applicant’s arguments, see remarks, filed 12/04/2025, with respect to the rejection(s) of claim(s) 1 and 7 under Hase in view of Mei have been fully considered and are persuasive as discussed with the applicant in the interview dated 12/04/2025. Therefore, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hase, Yamada and Mei.
As agreed upon in the interview, the examiner agrees that the previous prior art of Hase alone does not teach the amended claim limitation of claims 1 and 15 that the second electrode is located between the electrical insulated plate and the piezoelectric material, wherein the electrical insulated plate contacts the second electrode, and wherein the electrical insulated plate is located between the third electrode and the second electrode. However, upon further consideration, necessitated by the amended limitation it has been found the prior art of record Yamada, does reasonably teach and disclose a second electrode which is located between the electrical insulated plate and the piezoelectric material, wherein the electrical insulated plate contacts the second electrode, and wherein the electrical insulated plate is located between the third electrode and the second electrode (see further disclosure from Yamada [0039]-[0040], see also the Yamada annotated figure 3 above for further detail on how the 2nd and 3rd electrode are aligned with the insulated member and piezoelectric material). Therefore, as the newly amended limitations of claim 1 and 15 are taught by the new prior art of record Yamada, the claims 1 and 15 remain rejected under the new prior art of record rejection of Hase in view Yamada further in view of Mei set forth in the present office action.
As no further remarks have been made regarding any dependent claims, they too remain rejected under the prior art set forth in the present office action.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794