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 .
Priority
This application is a continuation of PCT/KR2023/008199 filed 06/14/2023. This application also claims priority to foreign applications KR10-2022-0072247 filed 06/14/2022 and KR10-2023-0074950 filed 06/12/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted were filed on 12/12/2024, 07/25/2025, and 12/15/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the specification: reference character 10 in figure 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
¶ [0067] of the specification filed 12/12/2024 discloses:
“As a result of the tissue experiment in the obese rat model, when applying 0.2 J of ultrasound energy in the dot type to the fat layer and comparing it with the other conditions of FIG. 3, it is identified that it is effective in the fat increase. And, in the fat layer or the sub dermis, both the dot type and the linear type of the ultrasound generator of FIG. 3 applied 0.2 J to 1.0 J of ultrasound energy to the fat layer, and the fat reduction occurred”.
It is unclear how when applying 0.2 J as dot type, results in both fat increase and fat reduction. Perhaps the inventors mean fat increases when applying less than 0.2 J rather than exactly 0.2 J, or that applying greater than 0.2 J, to 1.0 J, results in fat reduction (i.e. 0.2 < x < 1.0 J rather than 0.2 ≤ x ≤ 1.0 J).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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, 4, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi (US20180055478).
Regarding claim 1, Choi teaches an ultrasound generation device (10) (Figs. 1-5, Abstract, [0063], [0069]), comprising:
an ultrasound generator (200, 314) configured to irradiate ultrasound to skin (Figs. 1-4, [0006], [0069], [0072], “Accordingly, the treatment transducer 314 may perform a function of irradiating focused ultrasound”, [0074], [0082]); and
a controller (120) configured to control an operation of the ultrasound generator (200) (Fig. 1, [0067-0069]); wherein the controller (120) is configured to control the ultrasound generator to apply specific ultrasound energy corresponding to at least one of fat increase, fat reduction, or elastic fiber increase for a skin layer (Fig. 5, Abstract, [0066], [0069-0070], [0082], wherein applying focused ultrasound for reducing/removing subcutaneous fat comprises applying specific ultrasound energy corresponding to at least fat reduction).
Regarding claim 2, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the ultrasound generator (200) is configured to generate a focus point (30) at a vertical distance of 0.1 mm to 13 mm from a surface of the skin for at least one of fat increase, fat reduction, or elastic fiber increase (Figs. 1 & 4a, [0069], [0082], “…for operation of reducing or removing subcutaneous fat…an irradiation depth of focused ultrasound from skin surface is about 11.0 mm to 15.0 mm”).
Regarding claim 4, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the controller is configured to control the ultrasound generator to operate as a dot type ultrasound generator which focuses the irradiated ultrasound at focus points (12) according to a predetermined interval while the ultrasound generator (314) moves horizontally ([0074], wherein “move the treatment transducer 314 back and forth” comprises horizontally, “moved back and forth by a selected length within the range… irradiate focused ultrasound while moving within the range… irradiate focused ultrasound at predetermined intervals so that thermal focal points 12 form a plurality of dots along the same line”).
Regarding claim 8, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the controller is configured to control the ultrasound generator (314) to operate as a linear type ultrasound generator which continuously focuses the irradiated ultrasound at different positions corresponding to movement of the ultrasound generator ([0074], “The first driving device 218 may move the treatment transducer 314 back and forth…may be set to irradiate focused ultrasound so that the thermal focal points 12 form a straight line without intervals”, wherein moving back and forth such that the thermal focal points form a straight line without intervals comprises continuous focusing of ultrasound at different positions corresponding to movement of the ultrasound generator 314).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US20180055478) in view of Barthe (US20140276055).
Regarding claim 3, Choi teaches the invention as claimed above in claim 2.
However, Choi fails to teach wherein the specific ultrasound energy is in a range of 0.1 J to 3 J and has a frequency in a frequency range of 2 MHz to 20 MHz.
In an analogous ultrasound treatment device field of endeavor, Barthe teaches such a feature. Barthe teaches a cosmetic treatment system (20) comprising an ultrasound probe (100) having an ultrasound transducer therein (Figs. 1 & 3, [0133], [0135]). Barthe teaches wherein the system (20) may perform fat treatment comprising fat reduction (Abstract, [0100], [0108]). Barthe teaches wherein the system (20) includes a therapy subsystem (320) for performing the therapy (Fig. 8, [0164]). Barthe teaches the therapy subsystem may produce acoustic energy between about 0.01 joule (J) to about 10 J ([0170]). Barthe teaches wherein fat treatment may delivery energy at 1, 2, or 3 joules (J) and wherein the fat treatment frequency may be between 2-12 MHz ([0108]). Barthe therefore teaches applying ultrasound energy in a range of 0.1 J to 3 J and in a frequency range of 2 MHz to 20 MHz.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to apply 1-3 joules of energy at a frequency between 2-12 MHz as taught by Barthe ([0108]). The amount of said energy applied at said frequency may be used to treat fat for fat reduction as recognized by Barthe (Abstract, [0108], [0127]).
Regarding claim 20, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the ultrasound generator (314) is configured to irradiate the ultrasound to a depth of 0.1 mm to 13 mm ([0082-0083], wherein the irradiation depths may be 11-15 mm, less than 11 mm, 5-9 mm, and less than 6 mm overlaps with 0.1 to 13 mm).
However, Choi fails to teach wherein the ultrasound generator is configured to irradiate with a frequency of 2 MHz, 4 MHz, 5.5 MHz, 7 MHz, 10 MHz, and 20 MHz.
In an analogous ultrasound treatment device field of endeavor, Barthe teaches such a feature. Barthe teaches a cosmetic treatment system (20) comprising an ultrasound probe (100) having an ultrasound transducer therein (Figs. 1 & 3, [0133], [0135]). Barthe teaches wherein ultrasound therapy energy may be delivered at frequencies between 500 kHz to 25 MHz ([0110]). Barthe further teaches wherein the frequencies may range from 750 kHz to 20 MHz ([0284]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to have the ultrasound generator be configured to irradiate with frequencies between 500 KHz to 25 MHz as taught by Barthe ([0110], [0284]). These frequencies may be used for cosmetic treatment including sweat reduction as recognized by Barthe ([0110], [0282-0284]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Choi (US20180055478) in view of Fu (“Low-Intensity Pulsed Ultrasound Induced Enhanced Adipogenesis of Adipose-Derived Stem Cells”).
Regarding claim 5, Choi teaches the invention as claimed above in claim 4.
However, Choi fails to teach wherein the specific ultrasound energy is applied to a fat layer for fat increase.
In an analogous use of ultrasound for the treatment of fat field of endeavor, Fu teaches such a feature. Fu teaches applying low-intensity pulsed ultrasound (LIPUS) on adipose-derived stem cells (ASCs) (Abstract). Fu teaches that LIPUS induced enhanced adipogenesis of ASCs by increasing expression of adipogenic genes (Abstract, Page 318, paragraph above “Acknowledgements”). Fu therefore teaches wherein the application of ultrasound energy may increase fat, via inducing adipogenesis.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to apply low-intensity ultrasound to a fat layer to induce adipogenesis as taught by Fu (Abstract, Page 318, paragraph above “Acknowledgements”). By inducing adipogenesis, fat in certain areas of the body, e.g. the butt, may be increased, thereby providing a cosmetic benefit. Moreover as adipose-derived stem cells (ASCs) are located in the fat layer, Choi modified by the teachings of Fu to apply ultrasound to ASCs would predictably result wherein the specific ultrasound energy is applied to a fat layer, resulting in a fat increase via induction of adipogenesis.
However, the modified combination noted above fails to explicitly teach wherein the specific ultrasound energy is in a range of 0.1 J to 0.3 J.
While Choi in view of Fu fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi in view of Fu to have the specified ultrasound energy be in a range of 0.1 J to 0.3 J. Choi in view of Fu teaches applying ultrasound to a fat layer for fat increase via induction of adipogenesis. Choi in view of Fu therefore teaches a similar invention which is claimed except for the amount of ultrasound energy applied. The amount of ultrasound energy applied is a result-effective variable since the amount is correlated with the amount of mechanical stimuli/exposure applied, which may induce adipogenesis as taught by Fu (Page 318). The claimed range of 0.1 J to 0.3 J is therefore merely an optimum or workable range in which an ordinarily skilled artisan may arrive at through routine experimentation or optimization. There is no evidence disclosed of the 0.1 J to 0.3 J range being critically important other than for fat increase which Choi in view of Fu teaches, nor that the range yields unexpected results. 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 1995).
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US20180055478) in view of Emery (US20220023670).
Regarding claim 6, Choi teaches the invention as claimed above in claim 4.
However, Choi fails to teach wherein the specific ultrasound energy is in a range of 0.2 J to 0.6 J and is applied to a fat layer for fat reduction; or wherein the specific ultrasound energy is in a range of 0.2 J to 0.6 J and is applied to a fat layer via application to a sub dermis layer for fat reduction.
In an analogous ultrasound treatment device field of endeavor, Emery teaches such a feature. Emery teaches an ultrasound therapy system (20) including a probe (100) and ultrasound transducers ([0080-0081]). Emery teaches providing ultrasound energy via the ultrasound transducers ([0185]). Emery teaches acoustic energy may be produced for submental fat (e.g. double chin fat) ([0185], wherein submental fat comprises a fat layer, and treating submental fat comprises fat reduction). Emery teaches wherein the ultrasound energy applied may be in a range less than about 3 J, for example 0.25 J, 0.45 J, and 0.5 J ([0185]). Moreover, Emery teaches wherein the ultrasound system is adapted to achieve fat reduction ([0189]). Emery therefore teaches applying ultrasound energy in a range of 0.2 J to 0.6 J and is applied to a fat layer (submental fat) for fat reduction.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to apply ultrasound with an energy of 0.25, 0.45, or 0.5 J to submental fat for fat reduction as taught by Emery ([0185], [0189]). The ultrasound applied to submental fat may help get a person’s chin or neck fat, thereby providing a cosmetic benefit.
Regarding claim 9, Choi teaches the invention as claimed above in claim 8.
However, Choi fails to teach wherein the specific ultrasound energy is in a range of 0.2 J to 0.6 J of ultrasound energy and is applied to a fat layer for fat reduction; or wherein the specific ultrasound energy is in a range of 0.2 J to 0.6 J of ultrasound energy and is applied to a fat layer via application to a sub dermis layer for fat reduction.
In an analogous ultrasound treatment device field of endeavor, Emery teaches such a feature. Emery teaches an ultrasound therapy system (20) including a probe (100) and ultrasound transducers ([0080-0081]). Emery teaches providing ultrasound energy via the ultrasound transducers ([0185]). Emery teaches acoustic energy may be produced for submental fat (e.g. double chin fat) ([0185], wherein submental fat comprises a fat layer, and treating submental fat comprises fat reduction). Emery teaches wherein the ultrasound energy applied may be in a range less than about 3 J, for example 0.25 J, 0.45 J, and 0.5 J ([0185]). Moreover, Emery teaches wherein the ultrasound system is adapted to achieve fat reduction ([0189]). Emery therefore teaches applying ultrasound energy in a range of 0.2 J to 0.6 J and is applied to a fat layer (submental fat) for fat reduction.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to apply ultrasound with an energy of 0.25, 0.45, or 0.5 J to submental fat for fat reduction as taught by Emery ([0185], [0189]). The ultrasound applied to submental fat may help get a person’s chin or neck fat, thereby providing a cosmetic benefit.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US20180055478) in view of Kang (KR102081027; translation provided).
Regarding claim 7, Choi teaches the invention as claimed above in claim 4.
However, Choi fails to teach wherein the specific ultrasound energy is in a range of 0.2 J to 0.6 J and is applied to a dermis layer for elastic fiber increase.
In an analogous ultrasound treatment device field of endeavor, Kang teaches such a feature. Kang teaches an ultrasound lifting mask (10) configured to apply ultrasound energy to the skin to promote formation of collagen and elastin, thereby enhancing the lifting effect on wrinkles and sagging skin that have lost elasticity ([0001], [0018]). Kang teaches the mask (10) includes probe member (30) comprising a plurality of ultrasound probes (30a, 30b, 30c, 30d, 30e) (Fig. 1, [0018], [0023]). Kang teaches wherein the probes are configured to produce ultrasound energy between 0.1 J and 0.35 J to layers of the dermis ([0062-0066], [0069], wherein 30a & 30b produces 0.1-0.2 J, 30c produces 0.25-0.35 J, and 30d & 30e produces 0.2-0.3 J). Kang teaches the provided ultrasound energy promotes formation of collagen and elastin which results in the skin lifting ([0029]), [0043], [0045], [0069]). Kang therefore teaches providing ultrasound energy in a range of 0.2 J to 0.6 J to a dermis layer for elastic fiber increase (promotion of collagen/elastin formation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to have apply between 0.1 J to 0.35 J of ultrasound energy to areas of the face as taught by Kang (Fig. 1, [0062-0066], [0069]). This amount of energy provided may facilitate collagen and elastin formation, thereby producing a lifting effect on facial skin as recognized by Kang ([0029], [0043], [0045], [0069-0070]).
Regarding claim 10, Choi teaches the invention as claimed above in claim 8.
However, Choi fails to teach wherein the specific ultrasound energy is in a range of 0.2 J to 0.6 J and is applied to a dermis layer for elastic fiber increase.
In an analogous ultrasound treatment device field of endeavor, Kang teaches such a feature. Kang teaches an ultrasound lifting mask (10) configured to apply ultrasound energy to the skin to promote formation of collagen and elastin, thereby enhancing the lifting effect on wrinkles and sagging skin that have lost elasticity ([0001], [0018]). Kang teaches the mask (10) includes probe member (30) comprising a plurality of ultrasound probes (30a, 30b, 30c, 30d, 30e) (Fig. 1, [0018], [0023]). Kang teaches wherein the probes are configured to produce ultrasound energy between 0.1 J and 0.35 J to layers of the dermis ([0062-0066], [0069], wherein 30a & 30b produces 0.1-0.2 J, 30c produces 0.25-0.35 J, and 30d & 30e produces 0.2-0.3 J). Kang teaches the provided ultrasound energy promotes formation of collagen and elastin which results in the skin lifting ([0029]), [0043], [0045], [0069]). Kang therefore teaches providing ultrasound energy in a range of 0.2 J to 0.6 J to a dermis layer for elastic fiber increase (promotion of collagen/elastin formation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to have apply between 0.1 J to 0.35 J of ultrasound energy to areas of the face as taught by Kang (Fig. 1, [0062-0066], [0069]). This amount of energy provided may facilitate collagen and elastin formation, thereby producing a lifting effect on facial skin as recognized by Kang ([0029], [0043], [0045], [0069-0070]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Choi (US20180055478) in view of Fu (“Low-Intensity Pulsed Ultrasound Induced Enhanced Adipogenesis of Adipose-Derived Stem Cells”) and Kang (KR102081027; translation provided).
Regarding claim 11, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the controller is configured to: control the ultrasound generator (314) to operate as a dot type ultrasound generator; and control the ultrasound generator (314) to operate as a linear type ultrasound generator ([0074], “The treatment transducer 314 may be set to irradiate focused ultrasound at predetermined intervals so that thermal focal points 12 form a plurality of dots along the same line, or may be set to irradiate focused ultrasound so that the thermal focal points 12 form a straight line without intervals”, wherein forming a plurality of dots and forming a straight line without intervals comprises the controller configured to control the ultrasound generator 314 to operate either as a dot type or linear type ultrasound generator).
However, Choi fails to teach wherein the specific ultrasound energy is applied to a fat layer for fat increase.
In an analogous use of ultrasound for the treatment of fat field of endeavor, Fu teaches such a feature. Fu teaches applying low-intensity pulsed ultrasound (LIPUS) on adipose-derived stem cells (ASCs) (Abstract). Fu teaches that LIPUS induced enhanced adipogenesis of ASCs by increasing expression of adipogenic genes (Abstract, Page 318, paragraph above “Acknowledgements”). Fu therefore teaches wherein the application of ultrasound energy may increase fat, via inducing adipogenesis.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to apply low-intensity ultrasound to a fat layer to induce adipogenesis as taught by Fu (Abstract, Page 318, paragraph above “Acknowledgements”). By inducing adipogenesis, fat in certain areas of the body, e.g. the butt, may be increased, thereby providing a cosmetic benefit. Moreover as adipose-derived stem cells (ASCs) are located in the fat layer, Choi modified by the teachings of Fu to apply ultrasound to ASCs would predictably result wherein the specific ultrasound energy is applied to a fat layer, resulting in a fat increase via induction of adipogenesis.
However, the modified combination noted above fails to explicitly teach wherein the specific ultrasound energy is in a range of 0.1 J to 0.3 J.
While Choi in view of Fu fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi in view of Fu to have the specified ultrasound energy be in a range of 0.1 J to 0.3 J. Choi in view of Fu teaches applying ultrasound to a fat layer for fat increase via induction of adipogenesis. Choi in view of Fu therefore teaches a similar invention which is claimed except for the amount of ultrasound energy applied. The amount of ultrasound energy applied is a result-effective variable since the amount is correlated with the amount of mechanical stimuli/exposure applied, which may induce adipogenesis as taught by Fu (Page 318). The claimed range of 0.1 J to 0.3 J is therefore merely an optimum or workable range in which an ordinarily skilled artisan may arrive at through routine experimentation or optimization. There is no evidence disclosed of the 0.1 J to 0.3 J range being critically important other than for fat increase which Choi in view of Fu teaches, nor that the range yields unexpected results. 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 1995).
However, the modified combination noted above fails to teach explicitly teach wherein the specific ultrasound energy is in a range of 0.2-0.6 J to a dermis layer for elastic fiber increase.
In an analogous ultrasound treatment device field of endeavor, Kang teaches such a feature. Kang teaches an ultrasound lifting mask (10) configured to apply ultrasound energy to the skin to promote formation of collagen and elastin, thereby enhancing the lifting effect on wrinkles and sagging skin that have lost elasticity ([0001], [0018]). Kang teaches the mask (10) includes probe member (30) comprising a plurality of ultrasound probes (30a, 30b, 30c, 30d, 30e) (Fig. 1, [0018], [0023]). Kang teaches wherein the probes are configured to produce ultrasound energy between 0.1 J and 0.35 J to layers of the dermis ([0062-0066], [0069], wherein 30a & 30b produces 0.1-0.2 J, 30c produces 0.25-0.35 J, and 30d & 30e produces 0.2-0.3 J). Kang teaches the provided ultrasound energy promotes formation of collagen and elastin which results in the skin lifting ([0029]), [0043], [0045], [0069]). Kang therefore teaches providing ultrasound energy in a range of 0.2 J to 0.6 J to a dermis layer for elastic fiber increase (promotion of collagen/elastin formation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to have apply between 0.1 J to 0.35 J of ultrasound energy to areas of the face as taught by Kang (Fig. 1, [0062-0066], [0069]). This amount of energy provided may facilitate collagen and elastin formation, thereby producing a lifting effect on facial skin as recognized by Kang ([0029], [0043], [0045], [0069-0070]).
Claims 12-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US20180055478) in view of Desilets (US20060122509)
Regarding claim 12, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the controller is configured to control the ultrasound generator (314) to operate as a linear type ultrasound generator and as a dot type ultrasound generator ([0074], “The treatment transducer 314 may be set to irradiate focused ultrasound at predetermined intervals so that thermal focal points 12 form a plurality of dots along the same line, or may be set to irradiate focused ultrasound so that the thermal focal points 12 form a straight line without intervals”, wherein forming a plurality of dots at predetermined intervals and forming a straight line without intervals comprises the controller configured to control the ultrasound generator 314 to operate either as a dot type or as a linear type ultrasound generator).
However, Choi fails to teach wherein the ultrasound generator operates a linear type ultrasound generator during a first movement and as a dot type ultrasound generator during a second movement.
In an analogous ultrasound treatment device field of endeavor, Desilets teaches such a feature. Desilets teaches a HIFU ultrasound transducer (T) configured to move across a patient’s skin surface (2) (Fig. 1, [0041]). Desilets teaches wherein the transducer may operate as both a linear type (continuous wave mode) and as a dot type (pulse wave mode) during treatment (Fig. 5C, [0044]). As shown by figure 5C, dots and lines are formed by a plurality of movements including first and second movements (Fig. 5C). Desilets teaches forming a combination of dots (10d) and lines (10c) by alternating operating as linear type and dot type during movement (Fig. 5C, [0044]). Desilets therefore teaches wherein the ultrasound generator operates a linear type ultrasound generator during a first movement and as a dot type ultrasound generator during a second movement.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to alternate between dot and linear type during a treatment movement as taught by Desilets (Fig. 5C, [0044]). By alternating between dot and linear types, uniformity of treatment may be improved as applying linear type may help smoothen out the treatment dosage while dot type targets specific points. Moreover, incorporating dot type may prevent overheating compared to continually operating as linear/continuous type.
Regarding claim 13, Cho in view of Desilets teaches the invention as claimed above in claim 12.
Cho further teaches wherein the ultrasound generator (314) moves in a reciprocal motion (i.e. back and forth) ([0074], [0084]).
However, Choi fails to teach wherein the first movement is a movement from a first position to a second position and the second movement is a movement from the second position to the first position.
In an analogous ultrasound treatment device field of endeavor, Desilets teaches such a feature. Desilets teaches a HIFU ultrasound transducer (T) configured to move across a patient’s skin surface (2) (Fig. 1, [0041]). Desilets teaches wherein the transducer may alternate between linear type (continuous wave mode) and dot type (pulse wave mode) during treatment (Fig. 5C, [0044]). As shown by figure 5C, dots and lines are formed by a plurality of movements including first and second movements (Fig. 5C). Desilets similarly teaches wherein the transducer may move back and forth in a reciprocating manner ([0047], “the transducer can be programmed for repetitive motion over the same scan lines”). Since Choi (and Desilets) teaches wherein the ultrasound generator moves back and forth in a reciprocating manner, modifying the invention of Choi with the teachings of Desilets to alternate or switch between dot and linear type would predictably result wherein the ultrasound generator may operate as linear type during a first movement from a first position to a second position and operate as a dot type during a second movement from the second position to the first position.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to alternate or switch between dot and linear type during a treatment movement as taught by Desilets (Fig. 5C, [0044]). By alternating between dot and linear types, uniformity of treatment may be improved as applying linear type may help smoothen out the treatment dosage while dot type targets specific points. Moreover, incorporating dot type may prevent overheating compared to continually operating as linear/continuous type. Since Choi teaches wherein the transducer is configured to move in a reciprocating fashion ([0074], [0084]), the modification of Choi with the teachings of Desilets to switch operation types would result wherein a first movement from a first point to a second point may be linear type and once switched, a second movement from the second point to the first point to be dot type.
Regarding claim 16, Choi teaches the invention as claimed above in claim 1.
Choi further teaches wherein the controller is configured to control the ultrasound generator (314) to operate as a dot type ultrasound generator and as a linear type ultrasound generator ([0074], “The treatment transducer 314 may be set to irradiate focused ultrasound at predetermined intervals so that thermal focal points 12 form a plurality of dots along the same line, or may be set to irradiate focused ultrasound so that the thermal focal points 12 form a straight line without intervals”, wherein forming a plurality of dots at predetermined intervals and forming a straight line without intervals comprises the controller configured to control the ultrasound generator 314 to operate either as a dot type or as a linear type ultrasound generator).
However, Choi fails to teach wherein the ultrasound generator operates a dot type ultrasound generator during a first movement and as a linear type ultrasound generator during a second movement.
In an analogous ultrasound treatment device field of endeavor, Desilets teaches such a feature. Desilets teaches a HIFU ultrasound transducer (T) configured to move across a patient’s skin surface (2) (Fig. 1, [0041]). Desilets teaches wherein the transducer may operate as both a linear type (continuous wave mode) and as a dot type (pulse wave mode) during treatment (Fig. 5C, [0044]). As shown by figure 5C, dots and lines are formed by a plurality of movements including first and second movements (Fig. 5C). Desilets teaches forming a combination of dots (10d) and lines (10c) by alternating operating as linear type and dot type during movement (Fig. 5C, [0044]). Desilets therefore teaches wherein the ultrasound generator operates a linear type ultrasound generator during a first movement and as a dot type ultrasound generator during a second movement.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to alternate between dot and linear type during a treatment movement as taught by Desilets (Fig. 5C, [0044]). By alternating between dot and linear types, uniformity of treatment may be improved as applying linear type may help smoothen out the treatment dosage while dot type targets specific points. Moreover, incorporating dot type may prevent overheating compared to continually operating as linear/continuous type.
Regarding claim 17, Choi in view of Desilets teaches the invention as claimed above in claim 16.
Choi further teaches wherein the ultrasound generator (314) moves in a reciprocal motion (i.e. back and forth) ([0074], [0084]).
However, Choi fails to teach wherein the first movement is a movement from a first position to a second position and the second movement is a movement from the second position to the first position.
In an analogous ultrasound treatment device field of endeavor, Desilets teaches such a feature. Desilets teaches a HIFU ultrasound transducer (T) configured to move across a patient’s skin surface (2) (Fig. 1, [0041]). Desilets teaches wherein the transducer may alternate between linear type (continuous wave mode) and dot type (pulse wave mode) during treatment (Fig. 5C, [0044]). As shown by figure 5C, dots and lines are formed by a plurality of movements including first and second movements (Fig. 5C). Desilets similarly teaches wherein the transducer may move back and forth in a reciprocating manner ([0047], “the transducer can be programmed for repetitive motion over the same scan lines”). Since Choi (and Desilets) teaches wherein the ultrasound generator moves back and forth in a reciprocating manner, modifying the invention of Choi with the teachings of Desilets to alternate or switch between dot and linear type would predictably result wherein the ultrasound generator may operate as linear type during a first movement from a first position to a second position and operate as a dot type during a second movement from the second position to the first position.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Choi to alternate or switch between dot and linear type during a treatment movement as taught by Desilets (Fig. 5C, [0044]). By alternating between dot and linear types, uniformity of treatment may be improved as applying linear type may help smoothen out the treatment dosage while dot type targets specific points. Moreover, incorporating dot type may prevent overheating compared to continually operating as linear/continuous type. Since Choi teaches wherein the transducer is configured to move in a reciprocating fashion ([0074], [0084]), the modification of Choi with the teachings of Desilets to switch operation types would result wherein a first movement from a first point to a second point may be dot type and once switched, a second movement from the second point to the first point to be linear type.
Allowable Subject Matter
Claims 14-15 and 18-19 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.
Within the context of claims 14 and 18 the prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan “wherein the controller is configured to control the ultrasound generator to apply 0.1 J to 0.6 J of ultrasound energy to a fat layer during the first movement and to apply 0.2 J to 0.6 J of ultrasound energy to a dermis layer during the second movement”.
The most relevant prior arts are Choi (US20180055478), Desilets (US20060122509), and Domankevitz (US20160030772). Choi teaches an ultrasound generation device (200) configured to irradiate ultrasound for treatment, particularly for fat reduction (Figs. 1 & 4, [0067], [0069], [0072], [0082]). Choi teaches wherein the ultrasound generator (314) may operate as a dot type in which a plurality of dots are formed via focusing of ultrasound at predetermined intervals and as a linear type in which ultrasound is continuously radiated such that thermal focal points form a straight line without intervals ([0074]). Choi further teaches wherein the ultrasound generator (314) is configured to linearly reciprocate back and forth ([0074], [0084]), thereby producing first and second movements. Desilets teaches wherein the ultrasound generator/transducer may alternate between operating as dot type and linear type ([0044]). Therefore, Choi modified by the teachings of Desilets would result wherein the ultrasound generator may operate as one type during a first movement and as the other type during a second movement as the ultrasound generator linearly reciprocates or moves back and forth. Domankevitz teaches controlling the ultrasound generator/transducer (202) to sequentially target the dermis layer for skin tightening and then the fat layer for fat reduction (Fig. 5, [0013], [0032], [0035-0036], [0043]). However, Domankevitz fails to teach wherein the ultrasound generator operates as either a dot type nor a linear type as described by the invention. Therefore, modifying the combination of Choi and Desilets further with the teachings of Domankevitz to target the fat layer during the first movement in which the generator operates as a linear or dot type and the dermis layer during a second movement in which the generator operates as the other type would be improper. The prior arts cited herein thus fail to teach to a reasonably skilled artisan to target a fat layer during a first movement in which the ultrasound generator operates as either a linear type or dot type and to target a dermis layer during a second movement in which the ultrasound generator operates as the other type.
Conclusion
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/TOMMY T LY/ Examiner, Art Unit 3797
/COLIN T. SAKAMOTO/ Primary Examiner, Art Unit 3798