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 .
This Office action is responsive to an amendment filed April 8, 2026. Claims 2-25 are pending. New claims 22-25 have been added. Claim 1 has been canceled. Claims 2, 14, 16 & 18-21 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 11, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-5, 14-16, 19 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rem-Bronneberg et al. (US 2018/0264291) (“Rem-Bronneberg” hereinafter) in view of Hyuga (US 2008/0077017).
In regards to claim 2, Rem-Bronneberg discloses a system for ultrasound treatment (i.e., ablation or hyperthermia, see abstract), comprising:
an applicator 14 including a plurality of ultrasound units 8, each ultrasound unit 8 having at least one ultrasound element mounted on a cooled base 9 (i.e., the support 9 is cooled through the transducers 8 as part of the patch 14, which “may be coupled to a cooling circuit 25 adapted to circulate a cooling liquid around the ultrasound array. The cooling circuit can provide cooling to both: the ultrasound transducers and/or associated with them electronic circuitry; and to a body surface in contact with the patch”) and being configured to vibrate under excitation to produce ultrasound waves, wherein the plurality of ultrasound units 8 are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound units 8, the spaces enabling the applicator 14 to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer (see at least abstract, figs. 1a-b & 9a and par 0039-0040 & 0060);
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electrical circuitry 18 configured to excite ultrasound elements associated with the plurality of ultrasound units 8 to generate the ultrasound waves for heating target tissue beneath the epidermis layer (see at least abstract, figs. 6 & 7a and par 0008-0009, 0016, 0020, 0039-0040, 0043, 0052 & 0060-0063); and
a coolant source 25 connected to the applicator 14 while the applicator 14 is shaped in accordance with the contour of the non-flat tissue surface, to thereby cool the epidermis layer during heating of the target tissue beneath the epidermis layer (see at least fig. 1b and par 0040 & 0060).
Rem-Bronneberg discloses a system, as described above, that fails to explicitly teach a system with a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series.
However, Hyuga teaches that it is known to provide a system with each ultrasound unit (30, 60) having at least one ultrasound element mounted on a cooled base (11, 51) and a coolant source 29 connected to the applicator 1 in a manner enabling coolant to flow between the plurality of ultrasound units 30 in series (see at least abstract, figs. 1, 3(a)-6(c) & 8-12 and par 0048-0050, 0053, 0058, 0060 & 0069-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Rem-Bronneberg with a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series as taught by Hyuga since such a modification would amount to applying a known technique (i.e., as taught by Hyuga) to a known device (i.e., as taught by Rem-Bronneberg) ready for improvement to achieve a predictable result such as uniformly cooling the respective transducers by flowing the liquid heat transfer material through the gaps between the plural transducers such that the transducers can be directly cooled so that the temperature distribution in the plural ultrasonic arrays is averaged and the influence by the temperature on the ultrasonic transmission can be suppressed (see at least par 0028 & 0060 of Hyuga)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Rem-Bronneberg discloses the system of claim 2, further including a pump configured for circulating the coolant from the coolant source 25 to the plurality of ultrasound units 8 (see at least fig. 1b and par 0040 & 0060).
In regards to claim 4, Rem-Bronneberg discloses the system of claim 3, wherein the electrical circuitry 18 includes at least one processor configured to control the pump to maintain a temperature at the epidermis layer associated with the target tissue in a range of 50C to 400C (see at least fig. 7a and par 0054 & 0056).
In regards to claim 5, Rem-Bronneberg discloses the system of claim 2, wherein the electrical circuitry 18 includes at least one processor configured to cause ultrasound energy to be emitted at a frequency in a range of 9 MHz and 22 MHz (such as 9 or 10 MHz) (see at least par 0012, 0051 & 0060).
In regards to claim 14, Rem-Bronneberg discloses the system of claim 2, further including a plurality of flexible portions (of support 9) interconnecting the plurality of ultrasound units 8 (see at least fig. 1a and par 0040).
In regards to claim 15, Rem-Bronneberg discloses the system of claim 14, wherein each of the plurality of flexible portions (of support 9) is part of a common layer 9 of flexible material (see at least fig. 1a and par 0040).
In regards to claim 16, Rem-Bronneberg discloses a method for ultrasound treatment (i.e., ablation or hyperthermia, see abstract), the method comprising:
placing an applicator 14 on a non-flat tissue surface of epidermis, the applicator 14 including a plurality of ultrasound units 8 connected in series in a manner permitting the applicator 14 to flex in accordance with a contour of the non-flat tissue surface, and wherein each ultrasound unit 8 having at least one ultrasound element mounted on a cooled base 9 (i.e., the support 9 is cooled as part of the patch 14, which “may be coupled to a cooling circuit 25 adapted to circulate a cooling liquid around the ultrasound array. The cooling circuit can provide cooling to both: the ultrasound transducers and/or associated with them electronic circuitry; and to a body surface in contact with the patch,” see par 0040) and being configured to vibrate under excitation to produce ultrasound waves (see at least abstract, figs. 1a-b & 9a and par 0039-0040 & 0060);
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exciting the at least one ultrasound element 8 to generate the ultrasound waves for heating target tissue beneath the epidermis layer (see at least abstract, fig. 6 and par 0008-0009, 0016, 0020, 0039-0040, 0043, 0052 & 0060-0063); and
cooling the epidermis layer during heating of the target tissue beneath the epidermis layer using a coolant source 25 connected to the applicator 14 while the applicator 14 is shaped in accordance with the contour of the non-flat tissue surface (see at least fig. 1b and par 0040 & 0060).
Rem-Bronneberg discloses a method, as described above, that fails to explicitly teach a system with a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series.
However, Hyuga teaches that it is known to provide a method with each ultrasound unit (30, 60) having at least one ultrasound element mounted on a cooled base (11, 51) and a coolant source 29 connected to the applicator 1 in a manner enabling coolant to flow between the plurality of ultrasound units 30 in series (see at least abstract, figs. 1, 3(a)-6(c) & 8-12 and par 0048-0050, 0053, 0058, 0060 & 0069-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Rem-Bronneberg with a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series as taught by Hyuga since such a modification would amount to applying a known technique (i.e., as taught by Hyuga) to a known device (i.e., as taught by Rem-Bronneberg) ready for improvement to achieve a predictable result such as uniformly cooling the respective transducers by flowing the liquid heat transfer material through the gaps between the plural transducers such that the transducers can be directly cooled so that the temperature distribution in the plural ultrasonic arrays is averaged and the influence by the temperature on the ultrasonic transmission can be suppressed (see at least par 0028 & 0060 of Hyuga)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 19, Rem-Bronneberg discloses the method of claim 16, wherein exciting the at least one ultrasound element 8 includes exciting a first ultrasound element 8 to produce a first thermal effect at a first depth and exciting a second ultrasound element 8 to produce a second thermal effect different from the first thermal effect at a second depth, different from the first depth (see at least par 0039).
In regards to claim 21, Rem-Bronneberg discloses a non-transitory computer readable medium containing instructions that when executed by at least one processor cause the at least one processor to perform operations for ultrasound treatment (i.e., ablation or hyperthermia, see abstract), the operations comprising:
activating an applicator 14 including a plurality of ultrasound units 8, each ultrasound unit 8 having at least one ultrasound element 8 mounted on a cooled base 9 (i.e., the base 9 is cooled part of the patch 14, which “may be coupled to a cooling circuit 25 adapted to circulate a cooling liquid around the ultrasound array. The cooling circuit can provide cooling to both: the ultrasound transducers and/or associated with them electronic circuitry; and to a body surface in contact with the patch,” see par 0040) configured to vibrate under excitation to produce ultrasound waves, wherein the plurality of ultrasound units 8 are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound units 8, the spaces enabling the applicator 14 to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer (see at least abstract, figs. 1a-b & 9a and par 0039-0040 & 0060);
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exciting ultrasound elements associated with the plurality of ultrasound units 8 as the applicator 14 is shaped in accordance with the contour of the non-flat tissue, to generate the ultrasound waves for heating target tissue beneath the epidermis layer (see at least abstract, figs. 6 & 7a and par 0008-0009, 0016, 0020, 0039-0040, 0043, 0052 & 0060-0063); and
cooling the epidermis layer during heating of the target tissue beneath the epidermis layer using a coolant source 25 connected to the applicator 14 while the applicator 14 is shaped in accordance with the contour of the non-flat tissue surface (see at least fig. 1b and par 0040 & 0060).
Rem-Bronneberg discloses a non-transitory computer readable medium containing instructions that when executed by at least one processor fail to cause the at least one processor to perform operations for ultrasound treatment with a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series.
However, Hyuga teaches that it is known to provide discloses a non-transitory computer readable medium containing instructions that when executed by at least one processor fail to cause the at least one processor to perform operations for ultrasound treatment with each ultrasound unit (30, 60) having at least one ultrasound element mounted on a cooled base (11, 51) and a coolant source 29 connected to the applicator 1 in a manner enabling coolant to flow between the plurality of ultrasound units 30 in series (see at least abstract, figs. 1, 3(a)-6(c) & 8-12 and par 0048-0050, 0053, 0058, 0060 & 0069-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the non-transitory computer readable medium of Rem-Bronneberg containing instructions that when executed by at least one processor fail to cause the at least one processor to perform operations for ultrasound treatment with a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series as taught by Hyuga since such a modification would amount to applying a known technique (i.e., as taught by Hyuga) to a known device (i.e., as taught by Rem-Bronneberg) ready for improvement to achieve a predictable result such as uniformly cooling the respective transducers by flowing the liquid heat transfer material through the gaps between the plural transducers such that the transducers can be directly cooled so that the temperature distribution in the plural ultrasonic arrays is averaged and the influence by the temperature on the ultrasonic transmission can be suppressed (see at least par 0028 & 0060 of Hyuga)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 2-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (US 2012/0271294) (“Barthe” hereinafter) in view of Cornejo et al. (WO 99/48621) (“Cornejo” hereinafter) further in view of Hyuga (US 2008/0077017).
In regards to claim 2, Barthe discloses a system for ultrasound treatment (see at least par 0022, 0041, 0091, 0250, 0253-254 & 0260), comprising:
an applicator including a plurality of ultrasound units (19, 119, 219, 2404, 3104), each ultrasound unit (19, 119, 219, 2404, 3104) having at least one ultrasound element (e.g., transduction element(s)) mounted on a base (e.g., backing) (see at least par 0117, 0171, 0222, 0290 & 0307), each ultrasound unit (19, 119, 219, 2404, 3104) having at least one ultrasound element (19, 119, 219, 2404, 3104) configured to vibrate under excitation to produce ultrasound waves (see at least fig. 31 and par 0123, 0250 & 0290-0292),
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electrical circuitry (20, 86) configured to excite ultrasound elements (19, 119, 219, 2404, 3104) associated with the plurality of ultrasound units (19, 119, 219, 2404, 3104) to generate the ultrasound waves for heating target tissue beneath the epidermis layer (see at least figs. 5 & 7 and par 0136, 0188, 0241, 0260 & 0282); and
a coolant source (i.e., acoustic coupling and cooling system) connected to the applicator while the applicator is shaped in accordance with the contour of the non-flat tissue surface (see fig. 2), to thereby cool the epidermis layer during heating of the target tissue beneath the epidermis layer (see at least figs. 5 & 14 and par 0129, 0135, 0181, 0187, 0234, 0240, 0275, 0281, 0286-0287 & 0309).
Barthe discloses a system, as described above, that fails to explicitly teach a system wherein the plurality of ultrasound transducers are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound transducers, the spaces enabling the applicator to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer.
However, Cornejo teaches that it is known to provide a system wherein the plurality of ultrasound transducers (15, 32) are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound transducers (15, 32) (see fig. 2B),
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the spaces enabling the applicator to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer (see at least abstract, figs. 1A-C, 2A-B, 3A-C & 4 and pg. 2, lines 13-16; pg. 3, lines 12-15; pg. 6, lines 2-11).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe wherein the plurality of ultrasound transducers are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound transducers, the spaces enabling the applicator to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer as taught by Cornejo since such a modification would amount to applying a known technique (i.e., as taught by Cornejo) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as providing an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications (see pg. 4, lines 21-25 of Cornejo)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Barthe as modified by Cornejo discloses a system, as described above, that fails to explicitly teach a system with at least one ultrasound element mounted on a cooled base and a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series.
However, Hyuga teaches that it is known to provide a system with each ultrasound unit (30, 60) having at least one ultrasound element mounted on a cooled base (11, 51) and a coolant source 29 connected to the applicator 1 in a manner enabling coolant to flow between the plurality of ultrasound units 30 in series (see at least abstract, figs. 1, 3(a)-6(c) & 8-12 and par 0048-0050, 0053, 0058, 0060 & 0069-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe as modified by Cornejo with at least one ultrasound element mounted on a cooled base and a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series as taught by Hyuga since such a modification would amount to applying a known technique (i.e., as taught by Hyuga) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as uniformly cooling the respective transducers by flowing the liquid heat transfer material through the gaps between the plural transducers such that the transducers can be directly cooled so that the temperature distribution in the plural ultrasonic arrays is averaged and the influence by the temperature on the ultrasonic transmission can be suppressed (see at least par 0028 & 0060 of Hyuga)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 3, Barthe discloses the system of claim 2, further including a pump configured for circulating the coolant from the coolant source (i.e., acoustic coupling and cooling system) to the plurality of ultrasound units (19, 119, 219, 2404, 3104) (see at least par 0287).
In regards to claim 4, Barthe discloses the system of claim 3, wherein the electrical circuitry (20, 86) includes at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) configured to control the pump to maintain a temperature at the epidermis layer associated with the target tissue in a range of 50C to 400C (see at least par 0109, 0162 & 0209).
In regards to claim 5, Barthe discloses the system of claim 2, wherein the electrical circuitry (20, 86) includes at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) configured to cause ultrasound energy to be emitted at a frequency in a range of 9 MHz and 22 MHz (see at least par 0042, 0046, 0119-0120 & 0173-0174).
In regards to claim 6, Barthe discloses the system of claim 5, wherein the processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) is further configured to cause a temperature to rise to a value between 500C and 800C in the target tissue (see at least par 0203, 0217 & 0262-0263) at a depth of between 0.5 mm and 5 mm from the epidermis layer (see at least par 0041-0042 & 0250).
In regards to claim 7, Barthe discloses the system of claim 2, wherein the coolant is an antifreeze fluid (i.e., refrigerant) (see at least par 0287).
In regards to claim 8, Barthe discloses the system of claim 2, further including one or more temperature sensors (i.e., thermal sensor) configured to measure a temperature associated with the epidermis layer (see at least par 0134, 0137, 0186, 0189, 0242, 0268, 0280 & 0286-0288).
In regards to claim 9, Barthe discloses the system of claim 8, wherein the electrical circuitry (20, 86) includes at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) configured to control cooling of the epidermis layer based on temperature feedback from the one or more temperature sensors (i.e., thermal sensor) (see at least par 0137, 0189, 0242, 0268, 0286, 0280 & 0288).
In regards to claim 10, Barthe discloses the system of claim 2, wherein the electrical circuitry (20, 86) includes at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) configured to initiate cooling of the epidermis layer before heating of the target tissue (i.e., when operating in a closed loop feedback arrangement) (see at least figs. 8A-B and par 0129, 0135, 0181, 0187, 0234, 0240, 0275, 0281, 0286-0287 & 0309).
In regards to claim 11, Barthe discloses the system of claim 2, wherein the electrical circuitry (20, 86) includes at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) configured to initiate cooling of the epidermis layer after heating of the target tissue (i.e., when operating in a closed loop feedback arrangement) (see at least figs. 8A-B and par 0129, 0135, 0181, 0187, 0234, 0240, 0275, 0281, 0286-0287 & 0309).
In regards to claim 12, while Barthe discloses the system of claim 2, wherein the electrical circuitry (20, 86) includes at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) configured to initiate cooling of the epidermis layer (see at least figs. 8A-B and par 0129, 0135, 0181, 0187, 0234, 0240, 0275, 0281, 0286-0287 & 0309), Barthe as modified by Cornejo discloses the system of claim 2, that fails to explicitly teach a system wherein the electrical circuitry thereof includes at least one processor thereof configured to initiate cooling of the epidermis layer concurrently with heating of the target tissue. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of wherein the electrical circuitry thereof includes at least one processor, as taught by Barthe as modified by Cornejo configured to initiate cooling of the epidermis layer concurrently with heating of the target tissue as claimed in order to carefully balance the intensity of delivered energy to ensure that the desired target regions are sufficiently heated while surrounding areas of the tissue such as the superficial tissue interface and/or deeper into tissue are not damaged (see at least par 0286-0287 of Barthe).
In regards to claim 13, Barthe discloses the system of claim 2, further including at least one of an active cooling element or a passive cooling element for cooling the coolant (see at least par 0287).
In regards to claim 14, Barthe discloses the system of claim 2, that fails to explicitly teach a system further including a plurality of flexible portions interconnecting the plurality of ultrasound transducers. However, Cornejo teaches that it is known to provide a system further including a plurality of flexible portions (i.e., fiber sheet 25) interconnecting the plurality of ultrasound transducers (15, 32) (see at least 1A-C, 2A-B, 3A-C & 4 and pg. 2, lines 13-16; pg. 3, lines 12-15; pg. 6, lines 2-11). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe further including a plurality of flexible portions interconnecting the plurality of ultrasound transducers as taught by Cornejo since such a modification would amount to applying a known technique (i.e., as taught by Cornejo) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as providing an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications (see pg. 4, lines 21-25 of Cornejo)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Barthe discloses the system of claim 14, that fails to explicitly teach a system wherein each of the plurality of flexible portions is part of a common layer of flexible material. However, Cornejo teaches that it is known to provide a system wherein each of the plurality of flexible portions is part of a common layer 25 of flexible material (see at least fig. 2B). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe wherein each of the plurality of flexible portions is part of a common layer of the flexible material as taught by Cornejo since such a modification would amount to applying a known technique (i.e., as taught by Cornejo) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as providing an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications (see pg. 4, lines 21-25 of Cornejo)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 16, Barthe discloses a method for ultrasound treatment (see at least par 0022, 0041, 0091, 0250, 0253-254 & 0260), the method comprising:
placing an applicator on a non-flat tissue surface of epidermis, the applicator including a plurality of ultrasound units (19, 119, 219, 2404, 3104), and wherein each ultrasound unit (19, 119, 219, 2404, 3104) having at least one ultrasound element (e.g., transduction element(s)) mounted on a base (e.g., backing) (see at least par 0117, 0171, 0222, 0290 & 0307) and being configured to vibrate under excitation to produce ultrasound waves (see at least fig. 31 and par 0123, 0250 & 0290-0292);
exciting the ultrasound units (19, 119, 219, 2404, 3104) to generate the ultrasound waves for heating target tissue beneath the epidermis layer (see at least figs. 5 & 7 and par 0136, 0188, 0241, 0260 & 0282); and
cooling the epidermis layer during heating of the target tissue beneath the epidermis layer using a coolant source (i.e., acoustic coupling and cooling system) connected to the applicator (see at least figs. 5 & 14 and par 0129, 0135, 0181, 0187, 0234, 0240, 0275, 0281, 0286-0287 & 0309).
Barthe discloses a method, as described above, that fails to explicitly teach a method with the applicator including a plurality of ultrasound transducers connected in series in a manner permitting the applicator to flex in accordance with a contour of the non-flat tissue surface, and wherein each ultrasound transducer is configured to vibrate under excitation to produce ultrasound waves while the applicator is shaped in accordance with the contour of the non-flat tissue surface.
However, Cornejo teaches that it is known to provide a method with the applicator including a plurality of ultrasound transducers (15, 32) connected in series in a manner permitting the applicator to flex in accordance with a contour of the non-flat tissue surface, and wherein each ultrasound transducer (15, 32) is configured to vibrate under excitation to produce ultrasound waves while the applicator is shaped in accordance with the contour of the non-flat tissue surface (see at least abstract, figs. 1A-C, 2A-B, 3A-C & 4 and pg. 2, lines 13-16; pg. 3, lines 12-15; pg. 6, lines 2-11).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe with the applicator including a plurality of ultrasound transducers connected in series in a manner permitting the applicator to flex in accordance with a contour of the non-flat tissue surface, and wherein each ultrasound transducer is configured to vibrate under excitation to produce ultrasound waves while the applicator is shaped in accordance with the contour of the non-flat tissue surface as taught by Cornejo since such a modification would amount to applying a known technique (i.e., as taught by Cornejo) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as providing an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications (see pg. 4, lines 21-25 of Cornejo)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Barthe as modified Cornejo discloses a method, as described above, that fails to explicitly teach a method with at least one ultrasound element mounted on a cooled base and cooling using a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series.
However, Hyuga teaches that it is known to provide a method with at least one ultrasound element of ultrasound unit (30, 60) mounted on a cooled base (11, 51) and cooling using a coolant source 29 connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units (30, 60) in series (see at least abstract, figs. 1, 3(a)-6(c) & 8-12 and par 0048-0050, 0053, 0058, 0060 & 0069-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Barthe as modified by Cornejo with at least one ultrasound element mounted on a cooled base and cooling using a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series as taught by Hyuga since such a modification would amount to applying a known technique (i.e., as taught by Hyuga) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as uniformly cooling the respective transducers by flowing the liquid heat transfer material through the gaps between the plural transducers such that the transducers can be directly cooled so that the temperature distribution in the plural ultrasonic arrays is averaged and the influence by the temperature on the ultrasonic transmission can be suppressed (see at least par 0028 & 0060 of Hyuga)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 17, Barthe as modified by Cornejo discloses the method of claim 16, that fails to explicitly teach a method wherein cooling the epidermis layer is accomplished at a rate of between 1 K/min and 60 K/min. Barthe discloses (see at least figs. 8A-B and par 0286-0287 & 0309) that the cooling rate or flow needs to be optimized to control cooling of an interface surface or region between transducer probe and a region of interest and beyond and as such the cooling rate or flow of the device is disclosed to be a result effective variable in that it helps control cooling of an interface surface or region between transducer probe and a region of interest and beyond, thereby carefully balancing the intensity of delivered energy to ensure that the desired target regions are sufficiently heated while surrounding areas of the tissue such as the superficial tissue interface and/or deeper into tissue are not damaged. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Barthe as modified by Cornejo by cooling the epidermis layer at a rate of between 1 K/min and 60 K/min as a matter of routine optimization since it has been held that “where 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).
In regards to claim 18, Barthe discloses the method of claim 16, wherein exciting the at least one ultrasound element (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) includes concurrently operating at least two ultrasound elements (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) of the plurality of ultrasound units (19, 119, 219, 2404, 3104) at different frequencies to collectively emit unfocused ultrasound energy (see at least par 0120, 0149, 0174, 0200, 0225, 0255 & 0293).
In regards to claim 19, Barthe discloses the method of claim 16, wherein exciting the ultrasound elements (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) includes exciting a first ultrasound element (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) to produce a first thermal effect at a first depth and exciting a second ultrasound element (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) to produce a second thermal effect different from the first thermal effect at a second depth, different from the first depth (see at least par 0101, 0103, 0116, 0140, 0148, 0152, 0164, 0170, 0192, 0199-0200 & 0250-0253).
In regards to claim 20, Barthe discloses the method of claim 16, wherein wherein the method further comprises exciting a first set of the ultrasound elements (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) at frequencies in a range of 300 kHz and 1 MHz (see at least par 0042 & 0119, 0173, 0224 & 0291), while a second set of ultrasound elements (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) is excited at frequencies in a range of 10 MHz and 20 MHz (see at least par 0042 & 0119, 0173, 0224 & 0291).
In regards to claim 21, Barthe discloses a non-transitory computer readable medium containing instructions that when executed by at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) cause the at least one processor (see at least fig. 3 and par 0136, 0188, 0241, 0260 & 0282) to perform operations for ultrasound treatment (see at least par 0022, 0041, 0091, 0250, 0253-254 & 0260), the operations comprising:
activating an applicator including a plurality of ultrasound units (19, 119, 219, 2404, 3104), each ultrasound unit (19, 119, 219, 2404, 3104) having at least one ultrasound element (e.g., transduction element(s), see at least par 0117, 0171, 0222, 0290 & 0307) mounted on a base (e.g., backing) and being configured to vibrate under excitation to produce ultrasound waves (see at least fig. 31 and par 0123, 0250 & 0290-0292);
exciting ultrasound elements (19, 119, 219, 2404, 3104) associated with the plurality of ultrasound units (19, 119, 219, 2404, 3104) as the applicator is shaped in accordance with the contour of the non-flat tissue, to generate the ultrasound waves for heating target tissue beneath the epidermis layer (see at least figs. 5 & 7 and par 0136, 0188, 0241, 0260 & 0282); and
cooling the epidermis layer during heating of the target tissue beneath the epidermis layer using a coolant source (i.e., acoustic coupling and cooling system) connected to the applicator (see at least figs. 5 & 14 and par 0129, 0135, 0181, 0187, 0234, 0240, 0275, 0281, 0286-0287 & 0309).
Barthe discloses a non-transitory computer readable medium containing instructions that when executed by at least one processor fail to cause the at least one processor to perform operations for ultrasound treatment wherein the plurality of ultrasound transducers are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound transducers, the spaces enabling the applicator to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer while the applicator is shaped in accordance with the contour of the non-flat tissue surface.
However, Cornejo teaches that it is known to provide device for ultrasound treatment wherein the plurality of ultrasound transducers (15, 32) are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound transducers (15, 32) (see fig. 2B), the spaces enabling the applicator to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer while the applicator is shaped in accordance with the contour of the non-flat tissue surface (see at least abstract, figs. 1A-C, 2A-B, 3A-C & 4 and pg. 2, lines 13-16; pg. 3, lines 12-15; pg. 6, lines 2-11).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the non-transitory computer readable medium containing instructions that when executed by at least one processor cause the at least one processor of Barthe to perform operations for ultrasound treatment wherein the plurality of ultrasound transducers are interconnected side-by-side in series in a chain with spaces defined between adjacent ultrasound transducers, the spaces enabling the applicator to be flexed in accordance with a contour of a non-flat tissue surface of an epidermis layer while the applicator is shaped in accordance with the contour of the non-flat tissue surface as taught by Cornejo since such a modification would amount to applying a known technique (i.e., as taught by Cornejo) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as providing an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications (see pg. 4, lines 21-25 of Cornejo)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Barthe as modified by Cornejo discloses a non-transitory computer readable medium containing instructions that when executed by at least one processor fail to cause the at least one processor to perform operations for ultrasound treatment with at least one ultrasound element mounted on a cooled base and cooling using a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series.
However, Hyuga teaches that it is known to provide a method with at least one ultrasound element of ultrasound unit (30, 60) mounted on a cooled base (11, 51) and cooling using a coolant source 29 connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units (30, 60) in series (see at least abstract, figs. 1, 3(a)-6(c) & 8-12 and par 0048-0050, 0053, 0058, 0060 & 0069-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the non-transitory computer readable medium containing instructions that when executed by at least one processor cause the at least one processor of Barthe as modified by Cornejo to perform operations for ultrasound treatment with at least one ultrasound element mounted on a cooled base and cooling using a coolant source connected to the applicator in a manner enabling coolant to flow between the plurality of ultrasound units in series as taught by Hyuga since such a modification would amount to applying a known technique (i.e., as taught by Hyuga) to a known device (i.e., as taught by Barthe) ready for improvement to achieve a predictable result such as uniformly cooling the respective transducers by flowing the liquid heat transfer material through the gaps between the plural transducers such that the transducers can be directly cooled so that the temperature distribution in the plural ultrasonic arrays is averaged and the influence by the temperature on the ultrasonic transmission can be suppressed (see at least par 0028 & 0060 of Hyuga)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 22, while Hyuga further teaches that it is known to provide a system further including a coolant conduit (e.g., including circulation tubes 17a-b, 56a-b and gaps between ultrasound transducers (30, 60)) interconnecting the coolant source 29 with the plurality of ultrasound units (30, 60) (see at least figs. 3(c) & 6(c), par 0045-0046, 0059, 0067 & 0069), Barthe as modified Cornejo and Hyuga discloses the system of claim 2, that fails to explicitly teach a system further including a flexible coolant conduit. However, it would have been obvious to one ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe as modified by Cornejo and Hyuga with a flexible coolant conduit as claimed in order to provide an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications as suggested by Cornejo (see pg. 4, lines 21-25 of Cornejo).
In regards to claim 23, while Hyuga discloses a system wherein the coolant conduit (e.g., including circulation tubes 17a-b, 56a-b and gaps between ultrasound transducers (30, 60)) passes through the ultrasound units (30, 60) arranged in series in the chain (see at least figs. 3(a) & 6(a), par 0045-0046, 0059, 0067 & 0069), Barthe as modified Cornejo and Hyuga discloses the system of claim 22, that fails to explicitly teach a system wherein the coolant conduit is flexible. However, it would have been obvious to one ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe as modified by Cornejo and Hyuga with a flexible coolant conduit as claimed in order to provide an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications as suggested by Cornejo (see pg. 4, lines 21-25 of Cornejo).
In regards to claim 24, while Hyuga teaches that it is known to provide a system wherein the coolant conduit (e.g., including circulation tubes 17a-b, 56a-b and gaps between ultrasound transducers (30, 60)) is configured to circulate the coolant between the plurality of ultrasound units (30, 60) (see at least figs. 3(a) & 6(a), par 0045-0046, 0059, 0067 & 0069) while Cornejo teaches that it is known to provide a system the applicator is shaped in accordance with the contour of the non-flat tissue surface (see at least abstract, figs. 1A-C, 2A-B, 3A-C & 4 and pg. 2, lines 13-16; pg. 3, lines 12-15; pg. 6, lines 2-11), Barthe as modified Cornejo and Hyuga discloses the system of claim 23, that fails to explicitly teach a system wherein the coolant conduit is flexible. However, it would have been obvious to one ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Barthe as modified by Cornejo and Hyuga with a flexible coolant conduit as claimed in order to provide an ultrasound array that can permit acoustic energy generated by the transducers to be efficiently applied and coupled to the contours of the human anatomy for therapeutic applications as suggested by Cornejo (see pg. 4, lines 21-25 of Cornejo)..
In regards to claim 25, Barthe discloses the system of claim 24, wherein the applicator is configured to emit unfocused ultrasound (see at least par 0120, 0149, 0174, 0200, 0225, 0255 & 0293).
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/RENE T TOWA/Primary Examiner, Art Unit 3791
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