DETAILED ACTION
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
Acknowledgment is made to the amendment received 7/21/2025.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant's arguments filed 7/21/2025 have been fully considered but they are not persuasive. Regarding claim 1, applicant argues that sharp cutting edge 142 of Boudreaux does not disclose the claim language “wherein a slope of the incline portion reduces the sectional area in a direction from the proximal end to the distal end”. Regarding claim 22, applicant argues that sharp cutting edge 142 of Boudreaux does not disclose the claim language “wherein the incline portion is inclined with respect to the longitudinal direction of the tip”. However, the “incline portion” of claims 1 and 12 has been clarified below so that it is now explicitly disclosed by one specific part of the sharp cutting edge 142, as seen in Figure 1 below. This portion of sharp cutting edge 142 of Boudreaux does disclose the claim language “wherein a slope of the incline portion reduces the sectional area in a direction from the proximal end to the distal end” and “wherein the incline portion is inclined with respect to the longitudinal direction of the tip” as explained below. Thus, the previous rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Boudreaux stands.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 7-8, 11, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boudreaux et al., US 20170340344, herein referred to as “Boudreaux”.
Regarding claim 1, Boudreaux discloses a treatment device (Figures 7-8), comprising: an ultrasonic transducer (Figure 8: ultrasonic transducer assembly 130); a transmission rod (Figure 8: waveguide 132) with a proximal end and a distal end connecting to the ultrasonic transducer at the proximal end (Figure 8: the proximal end of waveguide 132 is connected to transducer assembly 130) and configured to transmit energy ([0001]: “These instruments include piezoelectric elements that convert electrical power into ultrasonic vibrations, which are communicated along an acoustic waveguide to the blade element.” And Figure 10); and a tip (Figures 7-8 and 9B: ultrasonic blade 140) with a first end and a second end detachably attached to the distal end of the transmission rod at the first end ([0085]), wherein the tip includes a hollow portion (Figure 9B: transverse opening 144) and an incline portion (see Figure 1 below), wherein the incline portion is configured to reduce a sectional area of the tip in a direction from the first end to the second end of the tip (Figure 9B and Figure 1 below: incline portion reduces a sectional area of the tip), and wherein a slope of the incline portion reduces the sectional area in a direction from the proximal end to the distal end (Figure 9B and Figure 1 below: a slope of the incline portion reduces a sectional area of the tip).
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Figure 1: Annotated Figure 9B of Boudreaux
Regarding claim 2, Boudreaux discloses the treatment device according to claim 1, wherein the tip and the transmission rod member are comprised of different materials (Figure 10: waveguide 132 and blade 140 are comprised of different materials; different can mean separate).
Regarding claim 7, Boudreaux discloses the treatment device according to claim 1, wherein a cover is detachably mounted to cover the transmission rod (Figures 7-8: housing 122 and [0047]: “Handle assembly (120) of this example includes housings (122) and a distal nose portion (124).” and [0085]) and the cover is fixedly attached to the tip (Figure 9B: distal nose portion 124 and [0047]: “Handle assembly (120) of this example includes housings (122) and a distal nose portion (124).” and [0085]: during operation of the device, distal nose portion 124 is fixedly attached to blade 140).
Regarding claim 8, Boudreaux discloses the treatment device according to claim 1, wherein the incline portion reduces the sectional area monotonically (See Figure 1 above and Figure 9B: incline portion reduces the sectional area consistently, without any reversals).
Regarding claim 11, Boudreaux discloses the treatment device according to claim 1, wherein a length of the tip is less than 2/10 of a length of a waveguide (Figures 8 and 10: when retracted, blade 140 does not reach halfway through distal nose portion 124, and waveguide 132 starts about halfway through distal nose portion 124 and extends the length of fluid conduits 118, which is much more than five times the length of blade 140).
Regarding claim 21, Boudreaux discloses the treatment device according to claim 1, wherein the incline portion is located in the tip on a proximal end side (See Figure 1 above and Figure 9B: incline portion is located on a proximal end side, this language is broad and thus the proximal end side is considered every portion of the tip except for the distal-most end).
Regarding claim 22, Boudreaux discloses the treatment device according to claim 1, wherein the incline portion is inclined with respect to the longitudinal direction of the tip (Figure 9B: incline portion is inclined with respect to the longitudinal direction of the tip).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Boudreaux in view of Bruns et al., US 20200345391, herein referred to as “Bruns”.
Regarding claim 3, Boudreaux in view of Shirley discloses the treatment device according to claim 2, but does not explicitly disclose a treatment device wherein the tip is comprised of Ti-6AL-4V, SUS316L, or SUS630.
However, Bruns teaches a treatment device (Figure 2) wherein the tip is comprised of Ti-6AL-4V, SUS316L, or SUS630 ([0039]: “Ultrasonic waveguide (28) and blade (24) may be fabricated from a solid core shaft constructed out of a material or combination of materials that propagates ultrasonic energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V), aluminum alloys, sapphire, stainless steel, or any other acoustically compatible material or combination of materials.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the tip is comprised of Ti-6AL-4V as taught by Bruns to ensure that the tip propagates ultrasonic energy efficiently (Bruns [0039]).
Regarding claim 4, Boudreaux in view of Shirley discloses the treatment device according to claim 2, but does not explicitly disclose a treatment device wherein the tip is comprised of a material having a Rockwell C hardness around 10 or higher.
However, Bruns teaches a treatment device (Figure 2) wherein the tip is comprised of a material having a Rockwell C hardness around 10 or higher ([0039]: “Ultrasonic waveguide (28) and blade (24) may be fabricated from a solid core shaft constructed out of a material or combination of materials that propagates ultrasonic energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V), aluminum alloys, sapphire, stainless steel, or any other acoustically compatible material or combination of materials.”; wherein Ti-6Al-4V has a Rockwell C hardness of around 30-35).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the tip is comprised of a material having a Rockwell C hardness around 10 or higher as taught by Bruns to ensure that the tip propagates ultrasonic energy efficiently (Bruns [0039]).
Regarding claim 5, Boudreaux in view of Shirley discloses the treatment device according to claim 2, but does not explicitly disclose a treatment device wherein the transmission rod is comprised of Ti-6AL-4V, SUS316L, or SUS630.
However, Bruns teaches a treatment device (Figure 2) wherein the transmission rod is comprised of Ti-6AL-4V, SUS316L, or SUS630 ([0039]: “Ultrasonic waveguide (28) and blade (24) may be fabricated from a solid core shaft constructed out of a material or combination of materials that propagates ultrasonic energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V), aluminum alloys, sapphire, stainless steel, or any other acoustically compatible material or combination of materials.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the transmission rod is comprised of Ti-6AL-4V as taught by Bruns to ensure that the tip propagates ultrasonic energy efficiently (Bruns [0039]).
Claims 6, 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Boudreaux in view of Shirley, further in view of Sanai et al., US 20100168741, herein referred to as “Sanai”.
Regarding claim 6, Boudreaux in view of Shirley discloses the treatment device according to claim 1, but does not explicitly disclose a treatment device wherein the tip includes a high frequency electrode and the transmission rod is configured to transmit high-frequency currents.
However, Sanai teaches a treatment device (Figure 1) wherein the tip includes a high frequency electrode ([0002]: “This apparatus is provided with an end effector for transmitting ultrasonic energy and high-frequency energy at a distal end part of a waveguide of an acoustic assembly body.”) and the transmission rod is configured to transmit high-frequency currents ([0062])
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the tip includes a high frequency electrode and the transmission rod is configured to transmit high-frequency currents as taught by Sanai so that treatments performed by ablation ultrasonic vibrations of high-frequency signals can be performed by the device (Sanai [0002]).
Regarding claim 9, Boudreaux discloses the treatment device according to claim 1, but does not explicitly disclose a treatment device wherein the tip includes more than one hollow portion.
However, Sanai teaches a treatment instrument (Figures 1 and 30) wherein the tip (Figure 30: blade 55d) includes more than one hollow portion (Figure 30: there are three hole parts 111).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the tip includes more than one hollow portion as taught by Sanai 2 to reduce the area of contact with the living tissue to thereby increase the current density of the high-frequency current.
Regarding claim 10, Boudreaux discloses the treatment device according to claim 1, but does not explicitly disclose a treatment device wherein the tip includes a bridge dividing the hollow portion.
However, Sanai teaches a treatment instrument (Figures 1 and 30) wherein the tip (Figure 30: blade 55d) includes a bridge dividing the hollow portion (Figure 30: there are bridges of blade 55d between each of the hole parts 111).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the tip includes a bridge dividing the hollow portion as taught by Sanai 2 so that there is an area with reduced contact area with the living tissue to thereby increase the current density of the high-frequency current.
Regarding claim 12, Boudreaux in view of Shirley discloses the treatment device according to claim 1, but does not explicitly disclose a treatment device wherein the first end of the tip is closer to an antinode position of vibration of the transmission rod than to a node position of the vibration of the transmission rod.
However, Sanai teaches a treatment instrument (Figures 1 and 26) wherein the first end of the tip (Figure 26: blade 55d) is closer to an antinode position of vibration of the transmission rod than to a node position of the vibration of the transmission rod (Figure 26 and [0115]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the treatment device disclosed by Boudreaux so that the first end of the tip is closer to an antinode position of vibration of the transmission rod than to a node position of the vibration of the transmission rod as taught by Sanai to maximize vibration at the distal end of the device (Sanai [0073]).
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 Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794