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 Objections
Claim 1 is objected to because of the following informalities: the claim limitation “the skin treatment device” in line 2 should be amended to read –the medical skin treatment device-- to be consistent with rest of claim 1. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the claim limitation “the skin” in line 6 should be amended to read –a skin-- to be consistent with rest of claim 1. Appropriate correction is required.
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 2-3 and 7 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.
Regarding claim 2, the claim limitation “the diameter” in line 3 is indefinite because it is unclear if this diameter is same diameter that is already recited in claim 1.
Claim 3 is rejected as it depends from rejected claim 2.
Regarding claim 7, the claim limitation “determine a voltage” in line 8 is indefinite because it is unclear if this determining a voltage is related to the “determine a voltage” that is recited in line 5 of claim 7.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Slayton et al. (US 2022/0040503; hereinafter Slayton), in view of Sverdlik et al. (US 2022/0008112; hereinafter Sverdlik).
Regarding claim 1, Slayton discloses a energy based fat reduction. Slayton teaches medical skin treatment device (see abstract; fig. 2), comprising: a main body (see combination of 204 and 206 in fig. 2) including a control unit (see 204 in fig. 2) for controlling an operation of the skin treatment device (see par. [0039]) and a power supply unit for supplying power to the medical skin treatment device (see par. [0056]); and a handpiece supplied with power from said power supply unit of said main body (see 202 in fig. 2; par. [0056]), controlled by said control unit (see par. [0056]), and improving the skin by forming lesions based on vibrational energy beneath a patient's skin surface (see par. [0030], [0031], [0034], [0035]) wherein said handpiece comprises: a base unit formed on one side of said handpiece (see fig. 2) and including a concave transducer placement surface (see par. [0084], [0085], [0092]; fig. 7); a plurality of ring-shaped transducers formed on the concave transducer placement surface of the base unit (see fig. 10B), vibrating at a predetermined treatment frequency to transmit vibrational energy to the patient's skin (see abstract and fig. 2); and a thermoelectric element (see par. [0095]), and cooling the plurality of transducers to prevent the patient's skin surface in contact with one side of the handpiece from being burned (see par. [0095]), wherein the plurality of transducers include a first transducer and a second transducer having a diameter larger than that of the first transducer (see fig. 10B), and wherein the plurality of transducers have different diameters and form concentric circles (see fig. 10B), and a plurality of focal points are formed vertically to simultaneously treat different layers beneath the skin (see fig. 5; par. [0092]).
But, Slayton fails to explicitly state a transport unit for moving said main body, and that the thermoelectric element is formed on the concave transducer placement surface of the base unit, formed along an outer periphery of the plurality of transducers.
Sverdlik discloses an ultrasound transducer and system for skin treatment. Slayton teaches a transport unit for moving said main body (see fig. 8), and that the thermoelectric element is formed on the transducer placement surface of the base unit (see 710 in fig. 4), formed along an outer periphery of the plurality of transducers (see thermoelectric 710 which is placed on outer periphery of plurality of transducers 702).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a transport unit for moving said main body, and that the thermoelectric element is formed on the transducer placement surface of the base unit, formed along an outer periphery of the plurality of transducers in the invention of Slayton, as taught by Sverdlik, to be able to easily move the ultrasound treatment device to multiple of location using the transport unit, and to be able to efficiently cool the external surface of the skin region by maintaining a specific temperature of the epidermis. The examiner notes that upon modification of prior art Slayton to incorporate the teaching of Sverdlik would provide thermoelectric element is formed on the concave transducer placement surface.
Regarding claim 2, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Slayton shows wherein a depth of the focal points formed beneath the skin by the plurality of transducers is each proportional to the diameter of the respective the plurality of transducers (see fig. 5, 6 and 10A).
Regarding claim 3, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Slayton shows the plurality of transducers radiate vibrational energy simultaneously or sequentially based on user input regarding a treatment area (see fig. 5, 6 and 10A).
Regarding claim 4, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Sverdlik teaches wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers (see par. [0329], [0330], [03333], [0340], [0348]), acquire a skin temperature corresponding to the cumulative shot count based on at least one of a first table or a first function that correlates the cumulative shot count to the skin temperature (see par. [0329], [0330], [03333], [0340], [0348]; fig. 9A-C) and determine a treatment shot count based on the skin temperature corresponding to the cumulative shot count (see par. [0329], [0330], [03333], [0340], [0348]; fig. 9A-C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers, acquire a skin temperature corresponding to the cumulative shot count based on at least one of a first table or a first function that correlates the cumulative shot count to the skin temperature and determine a treatment shot count based on the skin temperature corresponding to the cumulative shot count in the invention of Slayton, as taught by Sverdlik, to be able to efficiently cool the external surface of the skin region by maintaining a specific temperature of the epidermis to avoid damaging healthy tissue.
Regarding claim 5, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Sverdlik teaches wherein the control unit is configured to: acquire a cumulative irradiation time of the plurality of transducers (see par. [0051], [0113], [0199], [0245]; fig. 9A-C); acquire a skin temperature corresponding to the cumulative irradiation time based on at least one of a second table or a second function that correlates the cumulative irradiation time to the skin temperature (see par. [0051], [0113], [0199], [0245]; fig. 9A-C), and determine a treatment irradiation time based on the skin temperature corresponding to the cumulative irradiation time (see par. [0051], [0113], [0199], [0245]; fig. 9A-C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the control unit is configured to: acquire a cumulative irradiation time of the plurality of transducers; acquire a skin temperature corresponding to the cumulative irradiation time based on at least one of a second table or a second function that correlates the cumulative irradiation time to the skin, and determine a treatment irradiation time based on the skin temperature corresponding to the cumulative irradiation time in the invention of Slayton, as taught by Sverdlik, to be able to efficiently cool the external surface of the skin region by maintaining a specific temperature of the epidermis to avoid damaging healthy tissue.
Regarding claim 6, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Sverdlik teaches wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers (see par. [0329], [0330], [03333], [0340], [0348]), acquire a cumulative irradiation time of the plurality of transducers (see par. [0051], [0113], [0199], [0245]; fig. 9A-C), and determine at least one of a treatment shot count (see par. [0329], [0330], [03333], [0340], [0348]) and a treatment irradiation time (see par. [0051], [0113], [0199], [0245]; fig. 9A-C) based on at least one of the cumulative shot count and the cumulative irradiation time (see par. [0051], [0113], [0199], [0245], [0329], [0330], [03333], [0340], [0348]; fig. 9A-C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the control unit is configured to: acquire a cumulative shot count of the plurality of transducers, acquire a cumulative irradiation time of the plurality of transducers, and determine at least one of a treatment shot count, and a treatment irradiation time based on at least one of the cumulative shot count and the cumulative irradiation time in the invention of Slayton, as taught by Sverdlik, to be able to efficiently cool the external surface of the skin region by maintaining a specific temperature of the epidermis to avoid damaging healthy tissue.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Slayton et al. (US 2022/0040503; hereinafter Slayton), in view of Sverdlik et al. (US 2022/0008112; hereinafter Sverdlik) as applied to claimed 1 and further in view of Allison (US 2010/0081971).
Regarding claim 7, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Sverdlik teaches wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers ((see par. [0329], [0330], [03333], [0340], [0348])), acquire a cumulative irradiation time of the plurality of transducers ((see par. [0051], [0113], [0199], [0245]; fig. 9A-C)). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers, acquire a cumulative irradiation time of the plurality of transducers in the invention of Slayton, as taught by Sverdlik, to be able to efficiently cool the external surface of the skin region by maintaining a specific temperature of the epidermis to avoid damaging healthy tissue.
But, Slayton and Sverdlik fail to explicitly state determine a voltage to be applied to the thermoelectric element by applying at least one of the cumulative shot count and the cumulative irradiation time to at least one of a third-third table, a third-third function, a third-fourth table, and a third-fourth function during treatment period, and determine a voltage to be applied to the thermoelectric element by applying a treatment stoppage time to at least one of a third-fifth table and a third-fifth function during non-treatment period.
Allison discloses a treatment planning system. Allison teaches a voltage to be applied to the thermoelectric element by applying at least one of the cumulative shot count and the cumulative irradiation time to at least one of a third-third table, a third-third function, a third-fourth table, and a third-fourth function during treatment period (see par. [0061], [0101], [0122], [0159]), and determine a voltage to be applied to the thermoelectric element by applying a treatment stoppage time to at least one of a third-fifth table and a third-fifth function during non-treatment period (as best understood of indefinite language, see par. (see par. [0061], [0101], [0122], [0159]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a voltage to be applied to the thermoelectric element by applying at least one of the cumulative shot count and the cumulative irradiation time to at least one of a third-third table, a third-third function, a third-fourth table, and a third-fourth function during treatment period, and determine a voltage to be applied to the thermoelectric element by applying a treatment stoppage time to at least one of a third-fifth table and a third-fifth function during non-treatment period in the invention of Slayton and Sverdlik, as taught by Allison, to be able to provide efficient treatment by determining treatment parameters to achieve desired results.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Slayton et al. (US 2022/0040503; hereinafter Slayton), in view of Sverdlik et al. (US 2022/0008112; hereinafter Sverdlik) as applied to claimed 1 and further in view of Seo et al. (US 2014/0200488; hereinafter Seo) and Kim (US 2018/0154185).
Regarding claim 8, Slayton and Sverdlik disclose the invention substantially as described in the 103 rejection above, furthermore, Sverdlik teaches wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers (see par. [0061], [0101], [0122], [0159]), acquire a cumulative irradiation time of the plurality of transducers (see par. [0061], [0101], [0122], [0159]), determine skin temperature, by applying at least one of the cumulative shot count and the cumulative irradiation time to at least one of a first table, a first function, a second table, and a second function during treatment period (see par. [0051], [0113], [0199], [0245]; fig. 9A-C).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the control unit is configured to: acquire a cumulative shot count of the plurality of transducers, acquire a cumulative irradiation time of the plurality of transducers, determine skin temperature, by applying at least one of the cumulative shot count and the cumulative irradiation time to at least one of a first table, a first function, a second table, and a second function during treatment period in the invention of Slayton, as taught by Sverdlik, to be able to efficiently cool the external surface of the skin region by maintaining a specific temperature of the epidermis to avoid damaging healthy tissue.
But, Slayton and Sverdlik fail to explicitly state when the skin temperature is equal to or above a predetermined threshold temperature, discharge a predetermined amount of cooling gas, and determine temperature after the cooling gas discharge based on the skin temperature and the predetermined amount of cooling gas.
Seo discloses a method of cooling ultrasound treatment apparatus. Seo teaches when the skin temperature is equal to or above a predetermined threshold temperature, discharge a predetermined amount of cooling material (see par. [0011], [0012], [0014], [0042], [0046], [0049]) and determine temperature after the cooling gas discharge based on the skin temperature and the predetermined amount of cooling material (see par. [0011], [0012], [0014], [0042], [0046], [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of when the skin temperature is equal to or above a predetermined threshold temperature, discharge a predetermined amount of cooling material and determine temperature after the cooling gas discharge based on the skin temperature and the predetermined amount of cooling material in the invention of Slayton and Sverdlik, as taught by Seo, to be able to monitor and regulate the temperature at the treatment site to project and not damage healthy tissue.
But, Slayton, Sverdlik, and Seo fail to explicitly state that the cooling material is gas.
Kim discloses high intensity focus ultrasound device and teaching cooling material is gas (see par. [0014], [0039]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of using gas as the cooling material in the invention of Slayton, Sverdlik, and Seo, as taught by Kim, to provide a more efficient cooling material which limits heat spread to adjacent healthy tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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