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 .
Note: all citations with respect to the specification of present application are citing the paragraph number in the Pre-Grant Publication US 2025/0367479 A1.
Claim Objections
Claim 1, 13 and 14 are objected to because of the following informalities:
Claim 1 line 1 – 2, limitation "which radiates" should read "which is configured to radiate".
Claim 1 line 3, limitation "gripped by" should read "configured to be gripped by".
Claim 1 line 16, limitation "an Y-axis driving device" should read "a Y-axis driving device".
Claim 13 line 2, limitation "performs" should read "is configured to perform".
Claim 14 line 2, limitation "individually controls" should read "is configured to individually control".
Claim 14 line 3, limitation "radiates" should read "to radiate".
Claim 14 line 5, limitation "and delivers" should read "and to deliver".
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Limitation “connection part” in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding limitation “connection part” in claim 5, the corresponding structural disclosure in the specification of present application is recited as: “The connection part 43 is a component physically connecting the linear motor 42 and the transducer 30 and is mainly made of a lightweight metal or a reinforced polymer to enable precise force transmission” in [0071].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 3 is 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 3 recites limitation “adjust a voltage applied to the transducer in a range of 0.5 W/cm2 to 100 W/cm2” in line 6 – 7. The voltage is a well-defined term in the art and the unit of voltage is volt (symbol V). However, the above limitation uses the unit W/cm2 to further describe the applied voltage, which is a unit of power density not the volt. It is unclear what exact volts are applied in the unit of power density.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as any reasonable voltage range.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites limitation “wherein the X-axis driving device includes the linear motor, and wherein the Y-axis driving device includes the rotation motor.” However, same limitation is already recited in claim 1 line 14 (“an X-axis driving device including a linear motor”) and line 16 (“an Y-axis driving device including a rotation motor”).
Thus, claim 2 merely repeat the limitation as introduced in parent claim 1 and fails to further limit the subject matter of parent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (WO 2018124460 A1; published on 07/05/2018) (hereinafter "Kim").
Regarding claim 15, Kim discloses a high-intensity focused ultrasonic wave radiating method, which radiates high-intensity focused ultrasonic waves to a skin ("More particularly, the present invention relates to an image scanning and treatment technique using a high-intensity focused ultrasound (HIFU) device for treatment." [1]; "Haifu therapy can lessen the trauma of patients and achieve non-invasive treatment." [3]; since it is non-invasive treatment, the HIFU wave are transmitted from external and through the skin), the method comprising:
brining a cartridge housing installed in a handpiece into contact with the skin ("The treatment head 1 may be provided in a hand-held form in order to improve the convenience of the user's operation, separately from the apparatus main body. For example, a handle may be provided." [37]; "The treatment head 1 is inserted into the body, and an ultrasonic signal is applied to the tissue of the object." [35]);
radiating the ultrasonic waves to a target depth of the skin through a transducer disposed in the cartridge housing ("At this time, the treatment head 1 includes a body 10 and a transducer 12 connected to one end of the body 10 … and the therapeutic transducer converts the ultrasound signal into a focus Focusing to form a thermal lesion." [35]);
forming a first ultrasonic wave radiation trajectory by moving the transducer in an X-axis direction ("The first body 16 includes a wobbling driving unit 160 that generates a rotational force for wobbling the transducer unit 12, a shaft 190 that translationally moves by the rotation of the wobbling driving unit 160, And a connecting portion 192 for wobbling the transducer portion 12 within the set angle range about the wobbling axis by the translational movement of the transducer portion 190." [53]; see also Fig.2, the wobbling from 200a to 200b is along the x-axis);
changing a movement direction of the transducer to an Y-axis direction through a rotation motor ("The second body 18 includes a rotation driving unit 180 that rotates the entire first body 16 to rotate the shaft 190 and thereby generates a rotational force to rotate the transducer unit 12 … As shown in FIG. 8, when the rotation driving unit 180 is driven, the entire first body 16 rotates, and the transducer unit 12 rotates. The wobbling and rotational movement of the transducer 12 can be performed simultaneously or separately." [53]; see also Fig.3, when the transducer 12 is rotated, the wobbling from 300a to 300b is along the y-axis); and
forming a second ultrasonic wave radiation trajectory by moving the transducer in the Y-axis direction (see also Fig.3, when the transducer 12 is rotated, the wobbling from 300a to 300b is along the y-axis),
wherein a two-dimensional ultrasonic wave radiation pattern is formed by a combination of the first ultrasonic wave radiation trajectory and the second ultrasonic wave radiation trajectory ("... three-dimensional image scanning and three-dimensional focusing of the treatment region are possible through wobbling of the transducer portion 12. A high-fidelity signal can be focused and focused on the focal point while rotating the body 10 about the z-axis and translating in the z-axis direction. The translational motion in the Y-axis direction and the rotational motion about the X-axis can increase the operational convenience of the treatment head 1." [51]; the combination of movement in x and y axis will generate any desired pattern).
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 1 – 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Anthony et al. (US 2011/0166453 A1; published on 07/07/2011) (hereinafter "Anthony") and Yoon et al. (US 2025/0256131 A1; filed on 04/24/2023) (hereinafter "Yoon").
Regarding claim 1, Kim teaches a high-intensity focused ultrasonic wave providing device, which radiates high-intensity focused ultrasonic waves to a skin ("More particularly, the present invention relates to an image scanning and treatment technique using a high-intensity focused ultrasound (HIFU) device for treatment." [1]; "Haifu therapy can lessen the trauma of patients and achieve non-invasive treatment." [3]; since it is non-invasive treatment, the HIFU wave are transmitted from external and through the skin), the device comprising:
a handpiece gripped by a hand of a user ("The treatment head 1 may be provided in a hand-held form in order to improve the convenience of the user's operation, separately from the apparatus main body. For example, a handle may be provided." [37]);
a cartridge housing ("At this time, the treatment head 1 includes a body 10 …" [0035]) detachably coupled to the handpiece ("For example, a handle may be provided. At this time, a connection cable for electrically and physically connecting to the main body of the apparatus may be included." [0037]) and disposed adjacent to the skin when the ultrasonic waves are radiated to the skin ("Referring to FIG. 2, the transducer 12 of the treatment head ... and focuses a high signal on the treatment area to form a thermal lesion ..." [41]; considering the focal length is in the order of mm, the transducer head is adjacent to the skin);
a transducer disposed in the cartridge housing, configured to deliver the ultrasonic waves to the skin ("At this time, the treatment head 1 includes a body 10 and a transducer 12 connected to one end of the body 10 … and the therapeutic transducer converts the ultrasound signal into a focus Focusing to form a thermal lesion." [35]);
a driving device configured to move the transducer ("7 and 8 are internal structural diagrams of a treatment head for explaining a wobbling and rotation mechanism of a transducer unit …" [52]); and
a controller electrically connected to the driving device to control the driving device ("1 and 5, the control unit 32 includes a first mechanical adjustment unit 320 and a second mechanical adjustment unit 322, and may further include an electronic adjustment unit 324." [47]; "The control for the treatment head 1 can be automatically performed by the control unit 32." [48]) and configured to control the transducer and the driving device such that an ultrasonic wave radiation pattern having a spiral shape, a zigzag shape, or a wave shape is generated as the transducer moves ("... three-dimensional image scanning and three-dimensional focusing of the treatment region are possible through wobbling of the transducer portion 12. A high-fidelity signal can be focused and focused on the focal point while rotating the body 10 about the z-axis and translating in the z-axis direction. The translational motion in the Y-axis direction and the rotational motion about the X-axis can increase the operational convenience of the treatment head 1." [51]; the combination of movement in x and y axis will generate any desired pattern including spiral, zigzag and wave shapes),
wherein the driving device ("7 and 8 are internal structural diagrams of a treatment head for explaining a wobbling and rotation mechanism of a transducer unit …" [52]) includes:
an X-axis driving device including a linear motor configured to move the transducer in an X-axis direction ("The first body 16 includes a wobbling driving unit 160 that generates a rotational force for wobbling the transducer unit 12, a shaft 190 that translationally moves by the rotation of the wobbling driving unit 160, And a connecting portion 192 for wobbling the transducer portion 12 within the set angle range about the wobbling axis by the translational movement of the transducer portion 190." [53]; see also Fig.2, the wobbling from 200a to 200b is along the x-axis; in addition, the 160 and 190 together constitute a ballscrew-driven linear actuator, which is functionally equivalent to the linear motor); and
an Y-axis driving device including a rotation motor configured to rotate the X-axis driving device to move the transducer in an Y-axis direction ("The second body 18 includes a rotation driving unit 180 that rotates the entire first body 16 to rotate the shaft 190 and thereby generates a rotational force to rotate the transducer unit 12 … As shown in FIG. 8, when the rotation driving unit 180 is driven, the entire first body 16 rotates, and the transducer unit 12 rotates. The wobbling and rotational movement of the transducer 12 can be performed simultaneously or separately." [53]; see also Fig.3, when the transducer 12 is rotated, the wobbling from 300a to 300b is along the y-axis), and
wherein the X-axis direction and the Y-axis direction are two directions perpendicular to each other in a plane parallel to a skin contact surface of the cartridge housing (see Fig.2 and Fig.3).
In addition, Anthony teaches that, in the area of ultrasound probe, ballscrew-driven linear actuator and linear motor are switchable element ("For example, the linear drive system 122 can include a mechanical actuator, hydraulic actuator, pneumatic actuator, piezoelectric actuator, electro-mechanical actuator, linear motor, telescoping linear actuator, ballscrew-driven linear actuator, and so on. More generally, any actuator or combination of actuators suitable for use within a grippable, handheld form factor such as the trunk 140 may be suitably employed as the linear drive system 122." [0028]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to simply substitute one known element for another to obtain predictable results. See MPEP 2141. In this case, both linear actuator and linear motor are known elements for linear drive system suitable for use in the ultrasound probe. Both elements yield same translational movement as predictable result.
Kim in view of Anthony fails to explicitly teach the transducer having a focal length of 0.5 mm to 4.5 mm.
However, in the same field of endeavor, Yoon teaches a high-intensity focused ultrasonic wave providing device, which radiates high-intensity focused ultrasonic waves to a skin ("The present inventive concept provides a high intensity focused ultrasound (HIFU) device that is capable of transferring heat to a fascia layer, a collagen layer, or a dermis layer below the skin …" [0014]), the device comprising:
a transducer disposed in the cartridge housing ("Referring to FIG. 10, the transducer includes a transducer housing 100, an ultrasonic generator 200 including a HIFU piezoelectric body ..." [0054]), configured to deliver the ultrasonic waves to the skin, and having a focal length of 0.5 mm to 4.5 mm ("A transducer for the HIFU device may be designed such that a HIFU focus is formed at a position of 2.5 mm to 4.5 mm below the skin to transfer heat to a fascia layer, a collagen layer, or a dermis layer below the skin." [0051]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the HIFU transducer as taught by Kim with the HIFU transducer with specific focal length as taught by Yoon. Doing so would make it possible to provide "an ultrasound-focusing transducer used in high intensity focused ultrasound (HIFU) for multifocal treatment that is capable of simultaneously performing treatment at various treatment depths" (see Yoon; [0010]).
Regarding claim 2, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 1, and Kim further teaches wherein the X-axis driving device includes the linear motor ("The first body 16 includes a wobbling driving unit 160 that generates a rotational force for wobbling the transducer unit 12, a shaft 190 that translationally moves by the rotation of the wobbling driving unit 160, And a connecting portion 192 for wobbling the transducer portion 12 within the set angle range about the wobbling axis by the translational movement of the transducer portion 190." [53]; see also Fig.2, the wobbling from 200a to 200b is along the x-axis; in addition, the 160 and 190 together constitute a ballscrew-driven linear actuator, which is functionally equivalent to the linear motor), and
wherein the Y-axis driving device includes the rotation motor ("The second body 18 includes a rotation driving unit 180 that rotates the entire first body 16 to rotate the shaft 190 and thereby generates a rotational force to rotate the transducer unit 12 … As shown in FIG. 8, when the rotation driving unit 180 is driven, the entire first body 16 rotates, and the transducer unit 12 rotates. The wobbling and rotational movement of the transducer 12 can be performed simultaneously or separately." [53]; see also Fig.3, when the transducer 12 rotates, the wobbling from 300a to 300b is along the y-axis).
In addition, Anthony teaches that, in the area of ultrasound probe, ballscrew-driven linear actuator and linear motor are switchable element ("For example, the linear drive system 122 can include a mechanical actuator, hydraulic actuator, pneumatic actuator, piezoelectric actuator, electro-mechanical actuator, linear motor, telescoping linear actuator, ballscrew-driven linear actuator, and so on. More generally, any actuator or combination of actuators suitable for use within a grippable, handheld form factor such as the trunk 140 may be suitably employed as the linear drive system 122." [0028]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to simply substitute one known element for another to obtain predictable results. See MPEP 2141. In this case, both linear actuator and linear motor are known elements for linear drive system suitable for use in the ultrasound probe. Both elements yield same translational movement as predictable result.
Regarding claim 3, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 1, and Yoon further teaches wherein the controller is configured to:
perform a control to synchronize a moving speed and an ultrasonic wave output timing of the transducer and intermittently or continuously output the ultrasonic waves while the transducer moves ("The driving unit may be electrically connected to the circuit unit and the power supply through wires and may transmit a signal to the circuit unit such that a voltage is applied to the transducer, the HIFU piezoelectric body, and the piezoelectric linear motor for X-axis transfer." [0055]; "Since the transducer is usually moved over an entire face when the face is treated, a dermal layer and a collagen layer may be stimulated simultaneously when the transducer of the present inventive concept is used." [0059]); and
adjust a voltage applied to the transducer in a range of 0.5 W/cm2 to 100 W/cm2 to deliver ultrasonic energy optimized for each skin depth (see 112b rejection; "A signal may be received from the driving unit to apply a voltage to the transducer …" [0055]; since the limitation is indefinite, it is interpreted as any reasonable voltage. In addition, it would also be obvious to optimize the value through routine experiments; see MPEP 2144.05 II; “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the HIFU transducer as taught by Kim with the HIFU transducer with specific focal length as taught by Yoon. Doing so would make it possible to provide "an ultrasound-focusing transducer used in high intensity focused ultrasound (HIFU) for multifocal treatment that is capable of simultaneously performing treatment at various treatment depths" (see Yoon; [0010]).
Regarding claim 4, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 2, and Kim further teaches wherein the X-axis driving device and the transducer are coupled to each other ("The linearly movable member 130 linearly reciprocates with the movable member 140." [56]; see Fig.9, the member 130 connects driving section 160 and transducer 12) such that the transducer moves in the X-axis direction as the X-axis driving device moves forward or rearward ("Then, the linearly movable member 130 moves linearly in the same direction together with the movable member 140. At this time, the connection holes 122 connected to the transducer unit 12 are moved in the transverse direction from the position where the connecting shaft 131 of the linear moving member 130 is seated at the left edge, Wobbling motion in the clockwise direction. When the connection holes 122 are translated and rotated until the connection shaft 131 is seated on the right edge, the transducer 12 can be wobbled to an intermediate angle as shown in FIG. 10." [57]; see Fig.9 – 11).
Regarding claim 5, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 4, and Kim further teaches a connection part configured to couple the X-axis driving device and the transducer ("The linearly movable member 130 linearly reciprocates with the movable member 140." [56]; see Fig.9, the member 130 connects driving section 160 and transducer 12).
Regarding claim 6, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 5, and Kim further teaches wherein the controller is configured to:
rotate the rotation motor in an Y direction ("The second body 18 includes a rotation driving unit 180 that rotates the entire first body 16 to rotate the shaft 190 and thereby generates a rotational force to rotate the transducer unit 12." [53]); and
move the linear motor forward or rearward ("The linearly movable member 130 linearly reciprocates with the movable member 140." [56]; see Fig.9, the member 130 connects driving section 160 and transducer 12) such that the transducer moves in the Y direction after the rotation motor rotates in the Y direction ("Then, the linearly movable member 130 moves linearly in the same direction together with the movable member 140. At this time, the connection holes 122 connected to the transducer unit 12 are moved in the transverse direction from the position where the connecting shaft 131 of the linear moving member 130 is seated at the left edge, Wobbling motion in the clockwise direction. When the connection holes 122 are translated and rotated until the connection shaft 131 is seated on the right edge, the transducer 12 can be wobbled to an intermediate angle as shown in FIG. 10." [57]; see Fig.3).
Regarding claim 7, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 6, and Kim further teaches wherein the controller is configured to:
rotate the rotation motor in an X direction in a state in which the rotation motor rotates in the Y direction ("The second body 18 includes a rotation driving unit 180 that rotates the entire first body 16 to rotate the shaft 190 and thereby generates a rotational force to rotate the transducer unit 12." [53]; Fig.3 is the state of wobbling in Y direction and Fig.2 is the state of wobbling in X direction; rotating the 180 every 90 degree will switch the state between Fig.2 and Fig.3); and
move the linear motor forward or rearward ("The linearly movable member 130 linearly reciprocates with the movable member 140." [56]; see Fig.9, the member 130 connects driving section 160 and transducer 12) such that the transducer moves in the X direction after the rotation motor rotates in the X direction ("Then, the linearly movable member 130 moves linearly in the same direction together with the movable member 140. At this time, the connection holes 122 connected to the transducer unit 12 are moved in the transverse direction from the position where the connecting shaft 131 of the linear moving member 130 is seated at the left edge, Wobbling motion in the clockwise direction. When the connection holes 122 are translated and rotated until the connection shaft 131 is seated on the right edge, the transducer 12 can be wobbled to an intermediate angle as shown in FIG. 10." [57]; see Fig.2).
Regarding claim 8, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 7, and Kim further teaches wherein the rotation motor is fixed to the handpiece ("The treatment head 1 may be provided in a hand-held form in order to improve the convenience of the user's operation, separately from the apparatus main body. For example, a handle may be provided." [37]; "Referring to FIGS. 7 and 8, the treatment head includes a first body 16, a second body 18 …" [53]).
Regarding claim 9, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 1, and Yoon further teaches wherein the transducer includes:
a first transducer disposed in the cartridge housing ("… which includes two or more piezoelectric elements having a curvature, a piezoelectric element housing to which the piezoelectric elements are disposed and bonded …" [0012]); and
wherein the first transducer and the second transducer have different focal lengths ("A slope may be made in the arrangement of the two HIFU piezoelectric elements to adjust a focus interval between the piezoelectric elements and form a dual focus … thereby making ultrasound focal depths different." [0046]) and stimulate different depths of the skin through the different focal lengths ("In addition, ultrasonic waves may be simultaneously applied to skin layers having different depths ..." [0046]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the HIFU transducer as taught by Kim with the HIFU transducer with specific focal length as taught by Yoon. Doing so would make it possible to provide "an ultrasound-focusing transducer used in high intensity focused ultrasound (HIFU) for multifocal treatment that is capable of simultaneously performing treatment at various treatment depths" (see Yoon; [0010]).
Regarding claim 12, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 9, and Yoon further teaches wherein the first transducer has a focal length for stimulating an epidermis and an upper layer of a dermis of the skin, and wherein the second transducer has a focal length for stimulating a middle layer and a lower layer of the dermis of the skin ("In addition, the HIFU device may focus ultrasound waves down to different depths below the skin and specifically may focus ultrasound waves down to a depth of a combination of 1.5 mm and 3.0 mm, 1.5 mm and 4.5 mm, 1.5 mm and 6.0 mm, 3.0 mm and 4.5 mm, 3.0 mm and 6.0 mm, or 4.5 mm and 6.0 mm below the skin." [0060]; 1.5 mm is usually the range of epidermis and upper layer of dermis; 3.0 - 4.5 is usually the range of middle and lower layers of dermis).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the HIFU transducer as taught by Kim with the HIFU transducer with specific focal length as taught by Yoon. Doing so would make it possible to provide "an ultrasound-focusing transducer used in high intensity focused ultrasound (HIFU) for multifocal treatment that is capable of simultaneously performing treatment at various treatment depths" (see Yoon; [0010]).
Claim 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Anthony and Yoon, as applied in claim 9, and further in view of Emery et al. (US 2019/0142380 A1; published on 05/16/2019) (hereinafter "Emery").
Regarding claim 13, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 9, except wherein the controller performs a control to radiate the ultrasonic waves from a surface layer to a deep layer of the skin in a stepwise manner by sequentially driving the first transducer and the second transducer.
However, in the same field of endeavor, Emery teaches wherein the controller performs a control to radiate the ultrasonic waves from a surface layer to a deep layer of the skin ("… the controller 300 can be adapted to and/or configured to include, for example, a microprocessor with software and input/output devices, systems and devices for controlling electronic and/or mechanical scanning and/or multiplexing of transducers and/or multiplexing of transducer modules ..." [0106]) in a stepwise manner by sequentially driving the first transducer and the second transducer ("In one embodiment, the ultrasound system 20 is provided with two or more transducer modules 280. For example, a first transducer module can apply treatment at a first tissue depth (e.g., about 4.5 mm) and a second transducer module can apply treatment at a second tissue depth (e.g., of about 3 mm) ..." [0114]; "In one embodiment, a transducer module permits a treatment sequence at one, two, or more variable or fixed depths below the dermal layer …" [0118]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the HIFU transducer as taught by Kim with the transducer controlling adapted to different depths as taught by Emery. Doing so would make it possible that "treatment at different depths affects different types of tissue, thereby producing different clinical effects that together provide an enhanced overall cosmetic result" (see Emery; [0115]).
Regarding claim 14, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 9, except wherein the controller individually controls an intensity and an application time of a driving voltage supplied to the first transducer and the second transducer, radiates the ultrasonic waves from a surface layer to a deep layer of the skin in a stepwise manner, and delivers stimulation energy optimized for each skin depth.
However, in the same field of endeavor, Emery teaches wherein the controller individually controls an intensity and an application time of a driving voltage supplied to the first transducer and the second transducer ("… delivery of emitted energy 50 at a suitable focal depth 278, distribution, timing, and energy level is provided by the module 200 through controlled operation by the control system 300 …" [0120]; "Transducer modules can be adapted to and/or configured to apply ultrasonic energy at different target tissue depths." [0122]), radiates the ultrasonic waves from a surface layer to a deep layer of the skin in a stepwise manner ("In one embodiment, a transducer module permits a treatment sequence at one, two, or more variable or fixed depths below the dermal layer …" [0118]), and delivers stimulation energy optimized for each skin depth ("Some non-limiting embodiments of transducers 280 or modules 200 can be adapted to and/or configured for delivering ultrasonic energy at a tissue depth of 1.5 mm, 3 mm, 4.5 mm, 6 mm, 7 mm, less than 3 mm, between 3 mm and 4.5 mm, between 4.5 mm and 6 mm, more than more than 4.5 mm, more than 6 mm, etc., and anywhere in the ranges of 0-3 mm, 0-4.5 mm, 0-6 mm, 0-25 mm, 0-100 mm, etc. and any depths therein." [0114]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the HIFU transducer as taught by Kim with the transducer controlling adapted to different depths as taught by Emery. Doing so would make it possible that "treatment at different depths affects different types of tissue, thereby producing different clinical effects that together provide an enhanced overall cosmetic result" (see Emery; [0115]).
Allowable Subject Matter
Claim 10 and 11 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:
Regarding claim 10, Kim in view of Anthony and Yoon teaches all claim limitations, as applied in claim 9, except wherein the driving device includes: a first driving device configured to move the first transducer in the X-axis direction and the Y-axis direction; and a second driving device configured to move the second transducer in the X-axis direction and the Y-axis direction, and wherein the first driving device includes a first linear motor and a first rotation motor, and the second driving device includes a second linear motor and a second rotation motor.
Although cited prior art Kim teaches a set of linear actuator and rotation motor to drive one transducer in the x-direction and y-direction. There is only one set of actuator/motors for transducer movement. However, the claimed invention requires two separated sets of actuator/motor combination to drive two individual transducers.
Thus, neither cited prior arts nor other search results collectively teach or suggest all limitations as recited in claim 10.
Claim 11 is dependent on claim 10 and therefore inherently includes the allowable subject matter as recited in claim 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park (KR 20180089309 A; published on 08/08/2018) teaches an ultrasound transducer with two actuators to drive the movement of transducer to generate 2D radiation pattern on skin.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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