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 .
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “wherein the head portion of the transducer holder is formed so that at least a part of a side surface of the mounting groove is opened”. The limitation is unclear as to what is meant by a part of a side surface of the mounting groove is opened. For examination purposes, it has been interpreted that there is a space existing on a side surface or that there is an opening associating with the mounting groove and any surface thereof, however, clarification is required.
Claim 9 recites the limitation “the support protrusion is formed of a non-conductive material”. Examiner notes that claim 1 previously recites that the transducer holder is an electrode formed of a conductive material or an electrode comprising a surface coated with a conductive material. The limitation is therefore unclear because the support protrusion is recited in claim 8 as being a part of the transducer holder and it is unclear if the support protrusion is something other than the previously recited electrode or if the claim is intending to further narrow the transducer holder to be an electrode comprising a surface (e.g. a non-conductive surface such as the support protrusion) coated with a conductive material. For examination purposes, it has been interpreted that the support protrusion may be an addition to the transducer holder (e.g. is not an electrode), however, clarification is required.
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 1, 4-9, 11-12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kandori (US 20170059530 A1), hereinafter Kandori in view of Matsumoto (US 20180275305 A1), hereinafter Matsumoto.
Regarding claim 1,
Kandori discloses a high-intensity focused ultrasound generator, comprising:
an ultrasonic radiation frame (at least fig. 1B (101) and corresponding disclosure in at least [0033]) and a coupling hole (at least fig. 1B (102) and corresponding disclosure in at least [0033]) formed therein;
a transducer holder (at least fig. 2A (130 and 140) and fig. 14 (1401) and corresponding disclosure in at least [0046] and [0102] and/or at least fig. 4B (130, 132, and 170) and fig. 14 (1401) and corresponding disclosure in at least [0056]-[0057]) inserted into the coupling hole of the ultrasonic radiation frame (101) and detachably coupled through the ultrasonic radiation frame (101) (see at least figs. 2B-2C and 3B-3C);
a transducer (at least fig. 2A (110) and corresponding disclosure in at least [0041]) mounted on the transducer holder (130) (see at least fig. 2A);
and an insulating material (at least fig. 14 (260) and corresponding disclosure in at least [0128]);
wherein the transducer holder comprises an electrode formed of a conductive material or an electrode comprising a surface coated with a conductive material ([0102] which discloses interposer 1401 is a multilayer circuit substrate in which a glass epoxy-based resin and a conductive layer of copper film are layered);
wherein at least one of a front surface or a side surface of the transducer is electrically coupled to the transducer holder (see at least fig. 14 in which the transducer as a whole (thus including the front surface or the side surface) is electrically coupled to the transducer holder 130 and 1401 and [0105] which discloses the bottom surface of the chip 1201 is electrically connected to the electrode 1431 on the interposer 1401 by a solder bump 145);
and wherein a rear surface of the transducer has an electrical coupling through a current supply hole formed in a rear surface of the transducer holder (see at least fig. 14 depicting an electrical coupling (e.g. wire 160) through a current supply hole formed in a rear surface of the transducer holder 130).
Kandori fails to explicitly teach the insulating material is included in the ultrasound radiation frame.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have included such an insulating material as taught by fig. 14 of Kandori on the radiation frame as well in order to ensure the frame itself remains insulated and does not conduct heat/electricity to the subject/patient thereby enhancing the safety and comfort of the system during use.
Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the insulating material on the frame itself as such a modification amounts to merely a rearrangement of parts (i.e. including it as part of the frame instead of the transducer) yielding predictable results with respect to ultrasound transducer insulation thereby rendering the claim obvious. A person would have further recognized the benefit of doing so would reduce the manufacturing time and cost of the transducer by providing the insulation on the frame as opposed to each individual transducer.
While Kandori teaches the transducer holder comprises an electrode, it is not explicitly clear if the entire transducer holder is an electrode formed of a conductive material or an electrode comprising a surface coated with a conductive material.
Nonetheless, Matsumoto, teaches a transducer holder (at least fig. 1 (202) and corresponding disclosure in at least [0027]) on which a transducer (at least fig. 1 (206, 205, and 208) and corresponding disclosure in at least [0027]) is mounted, wherein the transducer holder is an electrode formed of a conductive material ([0027] which discloses metal housing 202).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the transducer holder (130) of Kandori to be an electrode formed of a conductive material (e.g. metal) as taught by Matsumoto as such a modification amounts to merely a simple substitution of one known housing material for another yielding predictable results with respect to ultrasound transmission/reception thereby rendering the claim obvious (MPEP 2143).
Regarding claim 4,
Kandori, as modified, teaches the elements of claim 1 as previously stated. Kandori further teaches wherein a surface of the transducer includes an insulating layer (at least fig. 14 (261) and corresponding disclosure in at least [0131]) coated with the insulating material (260).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the ultrasonic radiation frame of Kandori to include an insulating layer such as that provided in the transducer of fig. 14 in order to ensure an adhesive property of the insulating material (Kandori [0133]) to the ultrasonic radiation frame.
Regarding claim 5,
Kandori further teaches wherein the transducer holder includes:
a head portion (130) mounted on the ultrasonic radiation frame, wherein the head portion has a mounting groove formed therein into which the transducer is inserted and mounted (See at least fig. 14 depicting a groove which ultimately forms shoulders in the transducer holder in which the transducer 110 is inserted an mounted)
a body portion (140 or 132 and 170 of fig. 4B) that extends rearward from the head portion and penetrates the coupling hole and is coupled by a fastening member (at least fig. 2B/2C (151) and corresponding disclosure in at least [0047] and/or at least fig. 4B (depicting screw threads formed in through hole 102) as disclosed in at least [0057]) at the rear of the ultrasonic radiation frame (see at least figs. 2B/2C and 4B);
Regarding claim 6,
Kandori further teaches wherein the body portion of the transducer holder is formed with the current supply hole (see at least fig. 14), wherein the current supply hole is configured to allow one or more wires (at least fig. 14 (160) and corresponding disclosure in at least [0041]) to pass through and be withdrawn to the rear of the ultrasonic radiation frame (see at least fig. 14), and
wherein a space between the one or more wires and the current supply hole is sealed with waterproof glue (at least fig. 16 (134) and corresponding disclosure in at least [0140] which discloses posting material such as urethane-based resin and an epoxy based resin (i.e. glue) and is used for insulation and moisture-proofing)
Regarding claim 7,
Kandori further teaches wherein the head portion of the transducer holder is formed at that at least a part of a side surface of the mounting groove is opened (see at least 14. Examiner notes that a side surface (e.g. any surface) of the mounting groove is considered to be opened)
Regarding claim 8,
Kandori further teaches wherein the head portion has a support protrusion (1401 and/or at least fig. 14 (141) and corresponding disclosure in at least [0102]) that protrudes from a bottom surface of the mounting groove (see at least fig. 14), that supports a lower surface of the transducer, and that forms a space between the transducer and the bottom surface (see at least fig. 14).
Regarding claim 9,
Kandori further teaches wherein the support protrusion is formed of a non-conductive material ([0102] which discloses adhesive 141. Examiner notes that a person having ordinary skill in the art would have recognized the adhesive to be non-conductive)
Regarding claim 11,
Kandori further teaches wherein the body portion of the transducer holder includes:
A shaft portion (132) that extends rearward from the head portion (130) and is press-fitted into the coupling hole (see at least fig. 4B) and
A screw portion (170) that extends rearward from the shaft portion (see at least fig. 4B), that penetrates the coupling hole (see at least fig. 4B), and that is coupled with the fastening member (i.e. threads of hole 102) at the rear of the ultrasonic radiation frame (see at least fig. 4B).
Regarding claim 12,
Kandori further teaches wherein the side surface and the rear surface of the transducer are coated with at least one of a waterproof material or a non-conductive material (at least fig. 14 (261) and corresponding disclosure in at least [0128] and (141) and corresponding disclosure in at least [0102])
Regarding claim 20,
Kandori teaches a high-intensity focused ultrasound generator, comprising:
an ultrasonic radiation frame (at least fig. 1B (101) and corresponding disclosure in at least [0033]) having a probe (at least fig. 8 (805) and corresponding disclosure in at least [0072] and/or at least fig. 9 (11) and corresponding disclosure in at least [0005]) and a coupling hole (at least fig. 1B (102) and corresponding disclosure in at least [0033]);
a transducer holder (at least fig. 2A (130 and 140) and fig. 14 (1401) and corresponding disclosure in at least [0046] and [0102]) inserted into the coupling hole of the ultrasonic radiation frame (101) and detachably coupled at a rear of the ultrasonic radiation frame (101) (see at least figs. 2B-2C and 3B-3C);
a transducer (at least fig. 2A (110) and corresponding disclosure in at least [0041]) mounted on an open front surface of the transducer holder (130) (see at least fig. 2A);
and an insulating material (at least fig. 14 (260) and corresponding disclosure in at least [0128]);
wherein the transducer holder includes:
a head portion (130) mounted on the ultrasonic radiation frame, wherein the head portion has a mounting groove formed therein into which the transducer is inserted and mounted (See at least fig. 14 depicting a groove which ultimately forms shoulders in the transducer holder in which the transducer 110 is inserted an mounted)
a body portion (140) that extends rearward from the head portion and penetrates the coupling hole and is coupled by a fastening member (at least fig. 2B/2C (151) and corresponding disclosure in at least [0047]) at the rear of the ultrasonic radiation frame (see at least figs. 2B/2C);
wherein the head portion has a support protrusion (1401) that protrudes from a bottom surface of the mounting groove (see at least fig. 14), that supports a lower surface of the transducer, and that forms a space between the transducer and the bottom surface (see at least fig. 14)
wherein the transducer holder comprises an electrode formed of a conductive material or an electrode comprising a surface coated with a conductive material ([0102] which discloses interposer 1401 is a multilayer circuit substrate in which a glass epoxy-based resin and a conductive layer of copper film are layered);
wherein at least one of a front surface or a side surface of the transducer is electrically coupled to the transducer holder (see at least fig. 14 in which the transducer as a whole (thus including the front surface or the side surface) is electrically coupled to the transducer holder 130 and 1401 and [0105] which discloses the bottom surface of the chip 1201 is electrically connected to the electrode 1431 on the interposer 1401 by a solder bump 145);
and wherein a rear surface of the transducer has an electrical coupling through a current supply hole formed in a rear surface of the transducer holder (see at least fig. 14 depicting an electrical coupling (e.g. wire 160) through a current supply hole formed in a rear surface of the transducer holder 130).
Kandori fails to explicitly teach the insulating material is included in the ultrasound radiation frame.
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have included such an insulating material as taught by fig. 14 of Kandori on the frame itself in order to ensure the frame is insulated and does not conduct heat/electricity to the subject/patient. Additionally/alternatively, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the insulating material on the frame itself as such a modification amounts to merely a rearrangement of parts (i.e. including it as part of the frame instead of the transducer) yielding predictable results with respect to ultrasound transducer insulation thereby rendering the claim obvious. A person would have further recognized the benefit of doing so would reduce the manufacturing time and cost of the transducer by providing the insulation on the frame as opposed to each individual transducer.
While Kandori teaches the transducer holder comprises an electrode, it is not explicitly clear if the entire transducer holder is an electrode formed of a conductive material or an electrode comprising a surface coated with a conductive material.
Nonetheless, Matsumoto, teaches a transducer holder (at least fig. 1 (202) and corresponding disclosure in at least [0027]) on which a transducer (at least fig. 1 (206, 205, and 208) and corresponding disclosure in at least [0027]) is mounted, wherein the transducer holder is an electrode formed of a conductive material ([0027] which discloses metal housing 202).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the transducer holder (130) of Kandori to be an electrode formed of a conductive material (e.g. metal) as taught by Matsumoto as such a modification amounts to merely a simple substitution of one known housing material for another yielding predictable results with respect to ultrasound transmission/reception thereby rendering the claim obvious (MPEP 2143).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kandori and Matsumoto, as applied to claim 1 above, and further in view of Hyuga (US 2008007017 A1), hereinafter Hyuga.
Regarding claim 2,
Kandori, as modified, teaches the elements of claim 1 as previously stated. Kandori fails to explicitly teach wherein the insulation material comprises: a resin; or a carbon composite material including a carbon material mixed with a resin at a preset ratio.
Hyuga, in a similar field of endeavor involving ultrasound transducers, teaches an insulating film formed of a resin material ([0080] which discloses insulating films 81 formed of a resin material).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Kandori, as currently modified, to include an insulating material of resin as taught by Hyuga in order to improve electric reliability . Furthermore, such a modification amounts to merely a simple substation of one known insulating material for another yielding predictable results with respect to ultrasound insulation, thereby rendering the claim obvious (MPEP 2143).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kandori and Matsumoto, as applied to claim 1 above, and further in view of Foreign Fleury et al. (EP 2602788 A1), hereinafter Fleury. Examiner notes that citations to Fleury are with respect to the translated copy provided herein.
Regarding claim 3,
Kandori teaches the elements of claim 1 as previously stated. Kandori, as modified, fails to explicitly teach wherein the ultrasonic radiation frame includes a frame body portion.
Kandori fails to explicitly teach wherein the formed of a metal, and wherein the insulating layer is formed by anodizing a surface of the frame body portion.
Nonetheless, Fluery teaches wherein a frame body portion is formed of a metal, and wherein the insulating material is formed by anodizing a surface of the frame body portion )pg. 6 fourth paragraph which discloses the support element 4 is mainly made of metal or ceramic, for example anodized aluminum or alumina a surface treatment or an insulation deposit may be applied in the case of an electrically conductive support element 4).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the frame body portion and insulating material of Kandori to be formed of a metal and by anodizing a surface of the frame body portion as taught by Fleury in order to provide a suitably insulated support frame. Such a modification amounts to merely a simple substitution of one known support member material and insulation material for another yielding predictable results with respect to ultrasound transducer insulation, thereby rendering the claim obvious (MPEP 2143).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kandori and Matsumoto, as applied to claim 5 above, and further in view of Cooper et al. (US 6094402 A), hereinafter Cooper.
Regarding claim 10,
Kandori teaches the elements of claim 5 as previously stated. Kandori fails to explicitly teach wherein the head portion of the transducer holder is formed with a catch protrusion that protrudes from a bottom surface of the mounting groove and has a tip bent inward to prevent the transducer inserted into the mounting groove from being detached.
Cooper, in a similar field of endeavor involving ultrasonic transducers, teaches wherein a head portion of a transducer holder is formed with a catch protrusion (at least fig. 1 (34, 36, and/or 38) and corresponding disclosure in at least Col. 2) that protrudes from a bottom surface of a mounting groove and has a tip bent inward (at least fig. 1 (44, 46, and/or 48) and corresponding disclosure in at least Col. 2) to prevent a transducer (at least fig. 1 (12) and corresponding disclosure in at least Col. 2) inserted into the mounting groove from being detached (see at least fig. 4)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the head portion of Kandori as currently modified to include a catch protrusion as taught by Cooper in order to properly secure the transducer to the transducer holder accordingly. Such a modification would enhance the structural integrity of the system as a whole by ensuring the transducer remains in place during a procedure.
Claims 13-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kandori and Matsumoto, as applied to claim 5 above, and further in view of Kandori (US 10502713 B2), hereinafter Kandori 2.
Regarding claim 13,
Kandori further teaches wherein the transducer is one of a plurality of transducers of the high-intensity focused ultrasound generator (see at least figs. 7-9)
Wherein the high-intensity focused ultrasound generator further comprises an RF board, wherein the RF board is configured to electrically connect the plurality of transducers to each other and to supply RF power to the plurality of transducers ([0076] which discloses information of the transmitted ultrasound, such as size, shape, and time, is stored in the image information generating apparatus 803 as the ultrasound transmission information. In the image information generating apparatus 803, an image signal of the measurement object 800 is generated based on the ultrasound reception signal 706 and the ultrasound transmission information, and the reproduction image information 709 generated by ultrasound transmission and reception is output see at least figs. 7-9 in which the transducers are electrically connected to eachother via board 803/RF board therein).
Kandori fails to explicitly teach wherein the RF board is provided on the ultrasonic radiation frame.
Kandori (2), in a similar field of endeavor involving ultrasound generators, teaches an RF board (at least fig. 3A and/or 5A (400) and corresponding disclosure in at least Col. 6 lines 51-67) provided on an ultrasonic radiation frame (see at least fig. 3A and/or 5A (101) and corresponding disclosure in at least Col. 6 lines 51-67), wherein the RF board is configured to electrically connect the plurality of transducers to each other and to supply RF power to the plurality of transducers (Col. 7 lines 17-22 which discloses furthermore, wires connected to the voltage applying means 402 and output signals from the reception circuits 401 provided at a single circuit board 400 are bundled as a single cable and connected to the outside)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Kandori to include an RF board on the ultrasonic radiation frame as taught by Kandori 2 in order to reduce the number of cables in the entire ultrasound probe and achieve compact wiring inside the ultrasound probe (Kandori 2 Col. 7 lines 19-22)
Regarding claim 14,
Kandori, as modified, teaches the elements of claim 13 as previously stated. Kandori 2 as applied to claim 13 above further teaches wherein the RF board further includes one or more board connectors (at least fig. 5A (412) and corresponding disclosure in at least Col. 9 lines 38-55) corresponding to one or more wires (at least fig. 1 (151) and corresponding disclosure in at least Col. 9 lines 48-55), and to which the one or more wires are detachably connected (Examiner notes that a person having ordinary skill in the art would have recognized the ability to detach a wire (or printed circuit board) from a connector).
Regarding claim 15,
Kandori, as modified, teaches the elements of claim 13 as previously stated. Kandori 2 as applied to claim 13 above further teaches wherein the one or more board connectors are detachably connected to the RF board (Examiner notes that a person having ordinary skill in the art would have recognized the ability to detach the one or more board connectors from the RF board).
Regarding claim 17,
Kandori, as modified, teaches the elements of claim 13 as previously stated. Kandori, as currently modified, fails to explicitly teach further comprising an insulating cover formed to cover an outside of the RF board.
Nonetheless, since Kandori and Kandori 2 both teach insulating materials (e.g. films, adhesive, rubber, etc.) to insulating electrical components of the device, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have included an insulating cover (e.g. film, adhesive, etc. formed to cover an outside of the RF board in order to protect the printed circuit board from electrical interference thereby enhancing the safety and quality of the generator accordingly.
Regarding claim 18,
Kandori, as modified, teaches the elements of claim 13 as previously stated.
Kandori further teaches further comprising a probe coupled to a center of the ultrasonic radiation frame (at least fig. 8 (805) and corresponding disclosure in at least [0072] and/or at least fig. 9 (11) and corresponding disclosure in at least [0005])
Kandori 2 as applied to claim 13 above further teaches wherein the RF board is provided on a part of the rear of the ultrasonic radiation frame (see at least figs. 3A and 5A).
Regarding claim 19,
Kandori, as modified, teaches the elements of claim 13 as previously stated. Kandori further teaches wherein at least one of the rear surface of the side surface of the transducer and the transducer holder are bonded by an adhesive member so that the transducer is sealed while being vibrated inside the transducer holder (at least fig. 14 (261) and corresponding disclosure in at least [0128] and/or (141) and corresponding disclosure in at least [0102]); and
Wherein the transducer holder and the ultrasonic radiation frame are sealed by a sealing member ([0047] which discloses a gap between the acoustic wave transducer unit 103 and the support member 101 is sealed by the O-ring 150 (i.e. sealing member))
Regarding claim 16,
Kandori, as modified, teaches the elements of claim 16 as previously stated. Kandori fails to explicitly teach further comprising a monitoring sensor provided on the RF board and configured to independently monitor operating states of the plurality of transducers by detecting power supply states of wires respectively connected to the transducers.
Wu, in a similar field of endeavor involving ultrasound procedures, teaches a monitoring system configured to independently monitor operating states of a plurality of transducers by detecting power supply states of wires respectively connected to the transducers ([0035] which discloses controller is configured to determine coupling status by monitoring a characteristic of power supplied to the electroacoustic element 14 at a single frequency. The controller (i.e. monitoring sensor) 112 of the illustrated embodiment determines the coupling status by comparing a monitored voltage and/or current of the signal applied to the electroacoustic element against a predetermined decision boundary for that transducer 12. The operating frequency is determined individually for each transducer and [0041] discloses The appropriate operating frequency for each ultrasound device 10 may be determined individually by subjecting that device 10 to a reference coupling state, applying an AC signal to the transducer 12 at a plurality of different frequencies (e.g. a frequency sweep through a range of potential frequencies) and monitoring a characteristic of the power applied to transducer 12 (e.g. the current and/or voltage of the AC signal) to determine the operating frequency that provides optimal current and/or voltage readings).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Kandori, as currently modified, to include a monitoring sensor as taught by Wu in order to determine the operating frequency that provides optimal current and/or voltage readings (WU [0041]) and/or to determine the coupling status of the transducers (Wu [0035]). Such a modification would thereby enhance the operation of the transducers of Kandori accordingly.
Conclusion
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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