DETAILED ACTION
The following is a First Action, Non-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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because: Fig. 5 is shaded.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “using RF energy” to -configured to use radiofrequency (RF) energy- in ll. 1. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “a overlap” to -an overlap- in ll. 1. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “RF energy” to -the RF energy- in ll. 4. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “temperature” to -temperatures- in ll. 8. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “with treated tissue” to -with previously treated tissue- in ll. 10. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “the basis” to -a basis- in ll. 10. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “determines” to -is configured to determine- in ll. 1. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “that treatment for the target tissue is overlap” to -that the at least part of the target tissue overlaps with the previously treated tissue- in ll. 1-2.. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “other measured values” to -another of the values measured by the plurality of temperature sensors- in ll. 3. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “performs” to -is configured to perform- in ll. 1. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “that treatment for the target tissue is overlap” to -that the at least part of the target tissue overlaps with the previously treated tissue- in ll. 2-3. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: amend “performs control such that the RF energy is blocked upon determining that the target tissue overlaps with the treated tissue while the RF energy is transmitted to the electrode” to -is configured to perform the control while the RF energy is transmitted to the electrode- in ll. 1-3. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “sensors” to -temperature sensors- in ll. 4. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “the opposite” to -an opposite- in ll. 4. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “sensors” to -temperature sensors- in ll. 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “amend the dependency from “claim 4” to -claim 5- in ll. 1 to provide proper antecedent basis for “the opposite side of the substrate”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “the treated tissue” to -the previously treated tissue- in ll. 3. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “a overlap” to -an overlap- in ll. 1. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: amend “RF energy” to -the RF energy- in ll. 3. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “a temperature of at least one point among the temperature values measured at the plurality of points” to -at least one temperature measured among the temperatures measured at the plurality of points- in ll. 2-3. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “temperatures of the other points” to -other temperatures at the plurality of points- in ll. 3. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “RF energy” to -the RF energy- in ll. 2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “that different” to -that the different- in ll. 2. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “temperature measurement values” to -the temperature measurements- in ll. 2. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “RF energy” to -the RF energy- in ll. 2 & 4. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “tissue” to -the tissue- in ll. 4. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “the second treatment step is stopped when it is determined that treatment is overlap in the at least a part of the second treatment area in the overlap determination step” to -the second treatment step is stopped when it is determined that the at least the part of the second treatment area overlaps with the first treatment area in the overlap determination step- in ll. 1-3. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: amend “wherein the overlap determination step of determining whether at least a part of the second treatment area overlaps with the first treatment area comprises determining that treatment is overlaps” to -wherein the overlap determination step further comprises determining that the at least part of the second treatment area overlaps with the first treatment area- in ll. 1-3. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “wherein the overlap determination step comprises determining that treatment is overlap” to -wherein the overlap determination step further comprises determining that the at least part of the second treatment area overlaps with the first treatment area- in ll. 1-2. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “at least one point” to -at least one point of a plurality of points in the second treatment area” in ll. 2. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “of other points” to -of other points of the plurality of points in the second treatment area- in ll. 3. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “the basis” to -a basis-. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “a plurality of points” to -the plurality of points-. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “wherein the overlap determination step comprises determining overlapping” to -wherein the overlap determination step further comprises determining that the at least part of the second treatment area overlaps with the first treatment area- in ll. 1-2. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “the basis of temperatures” to -on the basis of the temperatures- in ll. 2. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “the overlap determination step comprises determining overlapping on the basis of temperatures measured at a plurality of points along the edge of the second treatment area” to -the plurality of points are located along an edge of the second treatment area- in ll. 1-3. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: amend “treatment is overlap in the second treatment area” to -the second treatment area overlaps the first treatment area- in ll. 2-3. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: amend “RF energy” to -the RF energy- in ll. 6. Appropriate correction is required.
Claim Interpretation
The Examiner notes that there are numerous grammatical errors in the claims which the Examiner has attempted to clarify with the objections above. The claims will be interpreted in the suggested manner by the Examiner.
The examiner also notes that the methods are seen as not being an abstract idea under 101 as the determination step and measurement steps are integrated into the delivery of the energy.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation “a sudden temperature increase”. The term “sudden” in claim 17 is a relative term which renders the claim indefinite. The term “sudden” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention and thus claim 17 is indefinite. For purposes of examination, “sudden” will be interpreted as any change in temperature after an initial temperature reading.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Liu et al. (2012/0226268).
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:
a first treatment step of treating tissue by transmitting RF energy to a first treatment area of the skin; a second treatment step of treating tissue by transmitting 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
an overlap determination step of determining whether at least a part of the second treatment area overlaps with the first treatment area during execution of the second treatment step (device 10 includes one or more sensors 26 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], [0166]).
Concerning claim 16, Liu et al. disclose the second treatment step is stopped when it is determined that treatment is overlap in the at least a part of the second treatment area in the overlap determination step (turning off radiation source) ([0012]).
Concerning claim 17, Liu et al. disclose the overlap determination step of determining whether at least a part of the second treatment area overlaps with the first treatment area comprises determining that treatment is overlap when a sudden temperature increase is detected from at least one point in the second treatment area ([0191]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (2004/0111087) in view of Liu et al. (2012/0226268).
Concerning claim 1, as illustrated in at least Figs. 1-3, Stern et al. disclose a skin treatment device using 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 and configured to measure temperature 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 determine whether at least a part of the target tissue overlaps with treated tissue on the basis of values measured by the plurality of temperature sensors. 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 determine whether at least a part of the target tissue overlaps with treated tissue on the basis of a value measured by a temperature sensor. 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 configured to determine whether at least a part of the target tissue overlaps with treated tissue on the basis of values measured by the plurality of temperature sensors in order to provide the benefit avoiding excessive treatment of an area as taught by Liu et al. ([0108], [0188-0189], [0191])
Claim(s) 2-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stern et al. (2004/0111087) in view of Liu et al. (2012/0226268), as applied to claim 1, in further view of Eckhouse et al. (2011/0245735).
Concerning claim 2, Stern et al. in view of Liu et al. fail to disclose the controller determines that treatment for the target tissue is overlap when one or more of the values measured by the plurality of temperature sensors increase faster than other measured values when the RF energy is transmitted to the electrode. However, Eckhouse et al. disclose a skin treatment system comprising a device and a controller configured to determine 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 controller determines that treatment for the target tissue is overlap when one or more of the values measured by the plurality of temperature sensors increase faster than other measured values when the RF energy is transmitted to the electrode 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]).
Concerning claim 3, Liu et al. further disclose the controller (18) performs control such that transmission of the RF energy is blocked upon determining that treatment for the target tissue is overlap ([0012]).
Concerning claim 4, Liu et al. further disclose the controller (18) performs control such that the RF energy is blocked upon determining that the target tissue overlaps with the treated tissue 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 sensors (42) is provided on the 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 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 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. 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. ([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 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]).
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. 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). 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 configured to determine whether at least a part of the target tissue overlaps with treated tissue on the basis of values measured by the plurality of temperature sensors 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]).
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 12 is rejected upon the same rationale as applied to claim 6.
Claim 13 is rejected upon the same rationale as applied to claim 7.
Claim 14 is rejected upon the same rationale as applied to claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fernando et al. (EP3842002) teach using light pulses and detecting brightness to determine if areas have previously been treated to prevent treatment overlap. Mehta et al. (2010/0249772) teach a skin treatment device using RF energy configured to treat multiple treatment regions and maintain respective treatment regions at a treatment temperature to limit overlapping ([0227]). Schwarz et al. (WO 2021/224678) teach a skin treatment device (4) comprising an electrode(s) (13), a plurality of temperature sensors (15), and a controller (11) configured to determine whether at least a part of the target tissue overheats on the basis of values measured by the plurality of temperature sensors (15) to employ a safety system preventing patient burns and ensuring homogeneity ([0070], [0093], [0118]; Fig. 1-4).
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