DETAILED ACTION
The following is a Final Office Action on the merits.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgment is made to the amendment received 4/6/2026.
Applicant’s amendments to the drawings are sufficient to overcome the drawings objection set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s cancellation of claim 17 is sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Claim Objections
Claim 1 is objected to because of the following informalities: delete “having an overlap treatment prevention function” in ll. 2 since the “controller” limitation recites this function. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “the target tissue” to -the at least the part of the target tissue overlaps- in ll. 3. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: delete “having an overlap treatment prevention function” in ll. 2 since the “controller” limitation recites this function. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “that different” to -that the different- in ll. 2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “transmission” to -the transmission- in ll. 2. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “during the tissue is treated” to -while treating the tissue- in ll. 10-11. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “temperatures” to -the temperatures- in ll. 6. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “first division lines” to -first division line- in ll. 3 (twice) since in Fig. 4 L2 (rectangular path having rounded corners) is just one line. 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 8-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitations “transmitting the RF energy … to an electrode” and “an electrode arrangement area for transmitting the RF energy to tissue”. It is unclear if the “electrode” and the “electrode arrangement area” are the same as or different from one another. For purposes of examination, they will be interpreted as being the same and only one electrode.
Claims 9-11 depend from claim 8 and are thus also rejected.
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) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (2004/0111087, previously cited) in view of Liu et al. (2012/0226268, previously cited) and Eckhouse et al. (2011/0245735, previously cited).
Concerning claim 1, as illustrated in at least Figs. 1-3, Stern et al. disclose a skin treatment device using radiofrequency (RF) energy (handpiece 10 for treating skin; Abstract, [0036]), comprising:
a main body (RF generator; [0037]);
a handpiece configured to receive RF energy from the main body (handpiece housing 14 is coupled to an RF generator; [0036-0037]);
an electrode provided on the handpiece and configured to transmit the RF energy to tissue (RF electrode 20; [0036-0037]);
a plurality of temperature sensors provided in the handpiece to measure temperatures of the target tissue (one or more thermal sensors 42 coupled to RF electrode 20 measure temperature and can provide feedback for monitoring temperature of RF electrode 20 and/or the tissue during treatment to facilitate control of the treatment; [0052]).
Stern et al. fail specifically disclose the device having an overlap treatment prevention function and comprising a controller configured to compare an increase rate of at least one of the temperatures of the target tissue measured by at least one of the plurality of temperature sensors to increase rates of other temperatures of the target tissue measured by others of the plurality of temperature sensors, and determine whether at least a part of the target tissue corresponding to the at least one of the plurality of temperature sensors overlaps with previously treated tissue on a basis of the comparison. However, Liu et al. disclose a skin treatment device (10) using RF energy having an overlap treatment prevention function, comprising a controller (18) configured to compare at least one of the temperatures of the target tissue measured by at least one of the plurality of temperature sensors to other temperatures of the target tissue measured by others of the plurality of temperature sensors, and determine whether at least a part of the target tissue corresponding to the at least one of the plurality of temperature sensors overlaps with previously treated tissue on a basis of the comparison. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. such that the device has an overlap treatment prevention function and comprises a controller to compare at least one of the temperatures of the target tissue measured by at least one of the plurality of temperature sensors to other temperatures of the target tissue measured by others of the plurality of temperature sensors, and determine whether at least a part of the target tissue corresponding to the at least one of the plurality of temperature sensors overlaps with previously treated tissue on a basis of the comparison in order to provide the benefit avoiding excessive treatment of an area as taught by Liu et al. ([0108], [0188-0189], [0191])
Stern et al. in view of Liu et al. fail to disclose the controller configured to determine that treatment for the target tissue overlaps by comparing an increase rate of a temperature measured by a temperature sensor with other increase rates of other temperatures measured by other temperature sensors. However, Eckhouse et al. disclose a skin treatment system comprising a device and a controller configured to determine conditions that may cause burns, blisters and other skin damage by comparing a measured temperature/measured temperatures with other measured temperature(s) or comparing a rate of temperature change/temperature changes with other rates of temperature change(s). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. in view of Liu et al. such that the controller is configured to determine that treatment for the target tissue overlaps by comparing an increase rate of a temperature measured by a temperature sensor with other increase rates of other temperatures measured by other temperature sensors in order to provide the benefit of avoiding skin damage as taught by Eckhouse et al. and since Eckhouse et al. teach the rate of change of temperature parameter to be an equivalent in the art to temperature values with respect to determining a condition that may cause burns, blisters and other skin damage. ([0008], [0010], [0030], [0034-0035], [0041], [0055-0056]).
Concerning claim 2, Eckhouse et al. further discloses the controller is configured to determine that the at least the part of the target tissue overlaps with the previously treated tissue when the increase rate of the at least one of the temperatures is greater than the increase rates of the other temperatures when the RF energy is transmitted to the electrode ([0008], [0010], [0030], [0034-0035], [0041], [0055-0056]).
Concerning claim 3, Liu et al. further disclose the controller (18) is configured to perform control such that transmission of the RF energy is blocked upon determining the at least the part of the target tissue overlaps with the previously treated tissue ([0012]).
Concerning claim 4, Liu et al. further disclose the controller (18) is configured to perform the control while the RF energy is transmitted to the electrode (20) ([0012]).
Concerning claim 5, Stern et al. disclose a substrate (30) provided at a distal end of the handpiece, wherein the electrode (28) is provided on one side of the substrate (30) facing outward, and the plurality of temperature sensors (42) are provided on an opposite side of the one side of the substrate (30) ([0052-0055]; Fig. 2-3).
Concerning claim 6, Stern et al. disclose at least some of the plurality of temperature sensors (42) are provided at positions corresponding to outer corners of the electrode (24) on the opposite side of the substrate (30) ([0052-0055]; Fig. 2-3).
Concerning claim 7, Stern et al. fail to disclose a display configured to receive a signal from the controller and to display information related to a position where the target tissue overlaps with the previously treated tissue. However, Liu et al. further disclose a display (32) configured to receive a signal from the controller (18) and to display (32) information related to a position where the target tissue overlaps with the treated tissue (display 32 provides audio and/or visual feedback of data detected, where data detected can be an excessive treatment area which is related to a position of overlap/excessive treatment area). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. to further comprise a display configured to receive a signal from the controller and to display information related to a position where the target tissue overlaps with the previously treated tissue in order to provide the benefit of displaying information relating to the treatment as taught by Liu et al. ([0191], [0286-0287])
Concerning claim 8, as illustrated in at least Figs. 1-3, Stern et al. disclose a method of controlling a skin treatment device using radiofrequency (RF) energy (method treating skin; [0036-0037]), the method comprising:
an RF energy transmission step of transmitting RF energy from an RF generator to an electrode in contact with tissue (RF electrode 20 transmits RF energy from RF generator to skin tissue; [0036-0037]);
a temperature measurement step in which a handpiece measures temperatures at a plurality of points in the tissue to which the RF energy is transmitted (one or more thermal sensors 42 coupled to RF electrode 20 measure temperature and provide feedback for monitoring temperature of RF electrode 20 and/or the tissue during treatment to facilitate control of the treatment; [0052]), wherein the temperature measurement step comprises receiving the temperatures from a plurality of sensors provided along an edge of an electrode arrangement area for transmitting the RF energy to tissue (one or more thermal sensors 42 can be coupled to the front 26 or back 24 surface/edge of electrode 20 and measure temperature and can provide feedback for monitoring temperature of Rf electrode 20 and/or the tissue during treatment; [0053], [0055]).
Stern et al. fail to specifically disclose the method having an overlap treatment prevention function and comprising an overlap treatment determination step in which an arithmetic operation unit determines whether at least a part of the target tissue overlaps with treated tissue on the basis of a value measured by a temperature sensor, wherein the overlap treatment determination step comprises an overlap area determination step of determining an overlap treatment point in the electrode arrangement area among the plurality of points. However, Liu et al. disclose a skin treatment device (10) using RF energy having an overlap treatment prevention function, comprising a controller (18) having an overlap treatment determination step in which an arithmetic operation unit (30) determines whether at least a part of the target tissue overlaps with treated tissue on the basis of a value measured by a temperature sensor (arithmetic operation of threshold comparison), wherein the overlap treatment determination step comprises an overlap area determination step of determining an overlap treatment point in the electrode arrangement area among the plurality of points. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. such that the device has an overlap treatment prevention function and comprising an overlap treatment determination step in which an arithmetic operation unit determines whether at least a part of the target tissue overlaps with treated tissue on the basis of a value measured by a temperature sensor, wherein the overlap treatment determination step comprises an overlap area determination step of determining an overlap treatment point in the electrode arrangement area among the plurality of points in order to provide the benefit avoiding excessive treatment of an area as taught by Liu et al. ([0109], [0188-0189], [0191])
Stern et al. in view of Liu et al. fail to disclose the overlap treatment determination step to be one in which the arithmetic operation unit determines whether different change trends appear among the temperatures measured at the plurality of points. However, Eckhouse et al. disclose a skin treatment system and method comprising a device and a controller having a treatment determination step in which an arithmetic operation unit determines whether a device is static, or not moving, based on a rate of temperature change based on temperature sensor readings, where a high rate of change is indicative of a static applicator, a condition that may cause burns, blisters and other skin damage, and multiple sensors enables a more accurate temperature measurement and rate of temperature change assessment. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. in view of Liu et al. such that the overlap treatment determination step is one in which the arithmetic operation unit determines whether different change trends appear among the temperatures measured at the plurality of points in order to provide the benefit of avoiding skin damage as taught by Eckhouse et al. and since Eckhouse et al. teach the rate of change of temperature parameter to be an equivalent in the art to temperature values with respect to determining a static condition of an applicator. ([0008], [0010], [0030], [0034-0035], [0041], [0055-0056]).
Stern et al. fail to disclose an overlap display step of displaying the overlap treatment point determined in the overlap area determination step on a display of the handpiece. However, Liu et al. further disclose an overlap display step of displaying the overlap treatment point (data detected) determined in the overlap area determination step on a display (32) of the handpiece (24). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. to further comprise a display configured to receive a signal from the controller and to display information related to a position where the target tissue overlaps with the treated tissue in order to provide the benefit of displaying information relating to the treatment as taught by Liu et al. ([0191], [0286-0287])
Claim 9 is rejected upon the same rationale as applied to claim 2.
Claim 10 is rejected upon the same rationale as applied to claim 3.
Claim 11 is rejected upon the same rationale as applied to claim 4.
Claim(s) 15-16 & 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (2012/0226268, previously cited) and Eckhouse et al. (2011/0245735, previously cited).
Concerning claim 15, as illustrated in at least Figs. 1 & 8A-B, Liu et al. disclose a skin treatment method using RF energy to prevent overlap treatment (method for providing fractional treatment of skin that can use radiofrequency spectrum radiation; [0007], [0097]), comprising:
treating tissue by transmitting the RF energy to a first treatment area of the skin; treating the tissue by transmitting the RF energy to a second treatment area adjacent to the first treatment area; (multiple linear arrays 92 of treatment spots 62 are directed across skin; [0011], [0097], [0183]) and
comparing at least one temperature measured in the second treatment area to another temperature measured in the second treatment area; and determining whether at least part of the second treatment area overlaps with the first treatment area based on the comparison during the tissue is treated by transmitting the RF energy to the second treatment area (device 10 includes one or more sensors 26, comprising one or more temperature sensors 108 for detecting the temperature of the treatment area 40 (such as the treatment spot 62 before, during, and/or after treatment) to detect loss of motion or excessive treatment (overlap) when sensed temperature or region of skin begins to heat above a threshold, where components of device 10, or other object and may be controlled to prevent, limit, or reduce the incidence or likelihood of treatment spot 62 overlap, e.g., based on feedback from one or more sensors 26; [0012-0014], [0113], [0116], [0128] [0166], [0191], [0199], [0202]).
Liu et al. fail to disclose comparing an increase rate of a temperature measured by a temperature sensor with other increase rates of other temperatures measured by other temperature sensors. However, Eckhouse et al. disclose a skin treatment system comprising a device and a controller configured to determine conditions that may cause burns, blisters and other skin damage by comparing a measured temperature/measured temperatures with other measured temperature(s) or comparing a rate of temperature change/temperature changes with other rates of temperature change(s). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stern et al. in view of Liu et al. such that the controller is configured to determine that treatment for the target tissue overlaps by comparing an increase rate of a temperature measured by a temperature sensor with other increase rates of other temperatures measured by other temperature sensors in order to provide the benefit of avoiding skin damage as taught by Eckhouse et al. and since Eckhouse et al. teach the rate of change of temperature parameter to be an equivalent in the art to temperature values with respect to determining a condition that may cause burns, blisters and other skin damage. ([0008], [0010], [0030], [0034-0035], [0041], [0055-0056]).
Concerning claim 16, Liu et al. disclose transmitting the RF energy to the second treatment area is stopped (turning off radiation source) when it is determined that the at least the part of the second treatment area overlaps with the first treatment area ([0012]).
Concerning claim 18, the modified invention of Liu et al. in view of Eckhouse et al. teach wherein the at least the part of the second treatment area is determined to overlap with the first treatment area when a temperature of at least one point of a plurality of points in the second treatment area increases faster than temperatures of other points in the plurality of points in the second treatment area on a basis of temperatures measured at the plurality of points in the second treatment area (See rejection of claim 15).
Concerning claim 19, Liu et al. disclose the plurality of points are located along an edge of the second treatment area (area of linear arrays 92 after the first are located on the edge ([0183-0184]; Fig. 8A-B).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (2012/0226268, previously cited) and Eckhouse et al. (2011/0245735, previously cited), as applied to claim 19, in further view of Fernando et al. (EP3842002, previously cited).
Concerning claim 20, Liu et al. in view of Eckhouse et al. fail to disclose wherein determining a direction in which the second treatment area overlaps the first treatment area; and displaying the direction in a treatment device for transmitting the RF energy. However, Fernando et al. disclose a skin treatment method that transmits energy and determines whether at least a part of a second treatment area overlaps with a first treatment area by determining a direction in which the second treatment area overlaps the first treatment area and displaying the direction in a treatment device for transmitting the energy (feedback signal is a display control signal, that causes the display unit to generate a graphical display comprising graphical representations of the previous treatment areas and the current treatment area overlaid on the body part, which inherently shows direction on the display). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Liu et al. in view of Eckhouse et al. such that the method further comprises determining a direction in which the second treatment area overlaps the first treatment area; and displaying the direction in a treatment device for transmitting the RF energy in order to provide the benefit of enabling the user to more easily see previously treated body parts and prevent overlap as taught by Fernando et al. ([0073-0081]; Fig. 6-7).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (2004/0111087, previously cited) in view of Liu et al. (2012/0226268, previously cited) and Eckhouse et al. (2011/0245735, previously cited), as applied to claim 19, in further view of Fernando et al. (EP3842002, previously cited).
Claim 21 is rejected upon the same rational as applied to claim 20.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (2004/0111087, previously cited) in view of Liu et al. (2012/0226268, previously cited), Eckhouse et al. (2011/0245735, previously cited) and Fernando et al. (EP3842002, previously cited), as applied to claim 21, in further view of Bartholomeusz et al. (2022/03140415).
The Examiner notes the right of priority has not been perfected since a translation of the priority application has not been filed.
Concerning claim 22, Stern et al. in view of Liu et al., Eckhouse et al. and Fernando et al. fail to disclose the electrode includes a plurality of electrodes disposed in a plurality of areas, respectively, the plurality of areas being divided by first division lines and second division lines, the first division lines each forming a rectangular path having rounded corners, the second division lines each forming a curved path that intersects the first division lines and extends radially outward. However, Batholomeusz et al. disclose a skin treatment method comprising an electrode includes a plurality of electrodes disposed in a plurality of areas, respectively, the plurality of areas being divided by first division lines (L2) and second division lines (L2), the first division lines (L2) each forming a rectangular path having rounded corners, the second division lines (L1) each forming a curved path that intersects the first division lines and extends radially outward. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Liu et al. in view of Eckhouse et al. such that the electrode includes a plurality of electrodes disposed in a plurality of areas, respectively, the plurality of areas being divided by first division lines and second division lines, the first division lines each forming a rectangular path having rounded corners, the second division lines each forming a curved path that intersects the first division lines and extends radially outward in order to provide the benefit of preventing tissue from being damaged by an edge effect as taught by Bartholomeusz et al. ([0010], [0048-0052], [0058]; Fig. 3).
Response to Arguments
Applicant's arguments filed 4/6/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the references fail to disclose the limitation of comparing increase rates of a temperature with other increase rates of other temperatures, the Examiner respectfully disagrees. As discussed in the rejections above, Liu et al. teach comparing a measured temperature with other measured temperatures to determine an area of overlap treatment that may cause skin damage, or excessive treatment. Eckhouse et al. teach using either a measured temperature of an increase rate of a measured temperature to automatically adjust an amount of energy, where a higher amount of energy may cause burns, blisters and other skin damage, all of which are excessive treatment, and thus teach the equivalence of using measured temperature or an increase rate of a measured temperature to provide the predictable result of excessive treatment feedback.
In response to Applicant’s arguments that Liu fails to disclose a display to display information related to a position of the overlap area, the Examiner respectfully disagrees. Liu et al. teach tissue a display 32 provides audio and/or visual feedback of data detected ([0286-0287), where data detected can be an excessive treatment area which is related to a position of overlap/excessive treatment area ([0191]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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