DETAILED ACTION
Response to Amendment
Claims 1-3 and 8 have been amended, and claims 4-7 and 9-10 have been cancelled. Rejections of amended claims have been updated or addressed below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/28/2026 was filed after the mailing date of the non-final office action on 4/28/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see page 5, filed on 7/28/2026, with respect to the previous drawing objections have been fully considered and are persuasive. The previous drawing objections are now moot and have been withdrawn.
Applicant’s arguments, see page 5, filed on 7/28/2026, with respect to the previous claim objection have been fully considered and are persuasive. The previous claim objection of claim 1 is now moot and has been withdrawn.
Applicant’s arguments, see pages 5-6, filed on 7/28/2026, with respect to the previous claim interpretation under 35 U.S.C. 112(f) have been fully considered and are persuasive. The previous claim interpretation under 112(f) of claims 1 and 8 are now moot and have been withdrawn.
Applicant’s arguments, see page 6, filed on 7/28/2026, with respect to the previous 35 U.S.C. 112(a) rejections have been fully considered and are persuasive. The previous 112(a) rejections of claims 1 and 8 are now moot and have been withdrawn.
Applicant’s arguments, see page 6, filed on 7/28/2026, with respect to the previous 35 U.S.C. 112(b) rejections have been fully considered. The previous 112(b) rejections of claims 1 and 8 due to the previous invocation of 112(f) are now moot and have been withdrawn. However, the previous 112(b) rejections of claims 3 and 6 were not addressed in Applicant’s arguments, and therefore are not withdrawn. Please see below.
Applicant's arguments, see pages 6-8, filed on 7/28/2026, with respect to the previous 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive. The Applicant argues that the combination of Prouza and Knowlton does not
disclose “the first pulse having an intensity that is lower than a maximum intensity of the pulse irradiated at the calculated specified time point” and “the second pulse having an intensity that is lower than the intensity of the first pulse or is progressively lower from the intensity of the first pulse”. The Examiner respectfully disagrees.
Knowlton teaches a method for treatment of tissue with feedback related to patient pain levels and thresholds. Knowlton teaches that “by quantifying patient sensation, the delivery of net energy to the target tissue can be … titrated to the patient’s perception of heat or pain” (Paragraph 0168, lines 5-9). Knowlton also teaches that “once the pain or thermal sensation level exceeds a certain threshold, system 54 or device 54 ' can be configured to … decrease the delivery of energy to the tissue” (Paragraph 0178, lines 10-13). Therefore, it is understood that Knowlton discloses “the second pulse having an intensity that is lower than the intensity of the first pulse or is progressively lower from the intensity of the first pulse”.
Knowlton also teaches that a feedback algorithm “can include a patient determined/calibrated numeric pain/thermal scale 54ps for particular levels of energy delivery” (Paragraph 0169, lines 2-4). Knowlton teaches that “numeric values can be determined for sub-threshold pain tolerance levels, threshold pain tolerance levels, and over threshold pain tolerance levels” (Paragraph 0169, lines 11-13). Knowlton teaches that “a database or model … correlates a pain or thermal sensation level to a particular energy delivery treatment parameter such as a power level (e.g. an RF power level)” (Paragraph 0178, lines 1-5). Therefore, it is understood that Knowlton discloses determining a maximum pulse intensity that correlates to when pain is experienced by the patient.
Furthermore, Knowlton teaches that “the patient’s perception of pain or heat … can be utilized to reduce … treatment or energy delivery so as to maintain temperature of non-target tissue below an injury threshold level” (Paragraph 0185, lines 3-7). Knowlton teaches that the energy level can be titrated to maintain pain perception at or below a level 1 (Paragraph 0112, lines 9-11) that correlates to a sub-threshold pain/thermal level (Paragraph 0169, lines 13-15). It can also be understood that “an injury threshold level” can correlate to when pain occurs for a patient. Therefore, it is understood that Knowlton also discloses “the first pulse having an intensity that is lower than a maximum intensity of the pulse irradiated at the calculated specified time point”. Thus, the previous 102/103 rejections are not withdrawn.
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 1-3 and 8 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.
The term “progressively” in claim 1 is a relative term which renders the claim indefinite. The term “progressively” 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. Because the term “progressively” is not defined in the specification, it is unclear what amount of energy a pulse is irradiated at in the second interval, and therefore renders the claim indefinite.
The term “some” in claim 3 is a relative term which renders the claim indefinite. The term “some” 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. Because the term “some” is not defined in the specification, the number of electrodes that the processor can control the energy supply to is unknown, and therefore renders the claim indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Prouza et al. (U.S. PGPub No. 2021/0146119) (previously cited) in view of Knowlton (U.S. PGPub No. 2003/0236487) (previously cited).
Regarding claim 1, Prouza teaches a pain relief (Paragraph 0023, lines 15-16)
device (Fig. 1, Paragraph 0104, line 1) for relieving pain (Paragraph 0023, lines 15-16) through control of output energy for each pulse and timing of cooling (Fig. 24, Paragraph 0283, lines 1-3), the pain relief device comprising: an electrode part (Fig. 4, Paragraph 0142, line 1) configured to be in contact with (Paragraph 0268, lines 1-4) surface of skin (Paragraph 0137, lines 3-4), and configured to deliver electrical energy (Paragraph 0037, lines 1-3) during a reference cycle (Paragraph 0045, lines 8-9); and a processor (Paragraph 0035, lines 4-6, Paragraph 0156, lines 9-11, and Paragraph 0274, lines 13-14) configured to: control the electrode part to deliver a first pulse with first energy level (Fig. 25, Paragraph 0286, lines 1-4) during a first interval (Fig. 3, Paragraph 0131, lines 4-7, range from beginning to 301a), and control the electrode part to deliver a second pulse with second energy level (Fig. 25, Paragraph 0286, lines 1-4 and Paragraph 0289, lines 10-12) during a second interval (Fig. 3, Paragraph 0131, lines 10-13, range from 301a to 301b), wherein the second interval is after the first interval (Fig. 23A, Paragraph 0276, lines 7-9), and wherein the second pulse has an intensity that is lower than the intensity of the first pulse or is progressively lower from the intensity of the first pulse (Paragraph 0286, lines 1-4 and Paragraph 0289, lines 10-12); and control a temperature of the surface of the skin to be lowered by a preset temperature (Fig. 24, Paragraph 0284, lines 1-4) in at least a portion between the first interval and the second interval (Fig. 24, Paragraph 0283, lines 7-12), wherein the reference cycle is a default unit time (Paragraph 0362, lines 1-3) to irradiate radio frequency (RF) energy to the skin through the electrode part (Paragraph 0052, lines 2-3), and is set within a range from a minimum irradiation time to a maximum irradiation time of the RF energy (Paragraph 0357, lines 1-4 and Paragraph 0435, lines 1-6).
Prouza does not teach that the processor is configured to: collect information whether a pain has occurred and when the pain has occurred while irradiating pulses to a patient during the reference cycle; and calculate a specified time point of a beginning of a specific pulse irradiated at the time the pain has occurred, based on the collected information.
Knowlton, however, teaches a method for treatment of tissue with feedback that uses an apparatus (Fig. 1, Paragraph 0083, line 1) that comprises a handpiece (Fig. 1, Paragraph 0085, line 2), an energy delivery device (Fig. 1, Paragraph 0086, line 1), a cooling device (Fig. 2B, Paragraph 0087, lines 3-4), and a processor (Paragraph 0087, line 11). Knowlton teaches that the apparatus further includes a user input part (Paragraph 0150, lines 4-5) that can collect, from a patient, whether and when a pain has occurred (Paragraph 0150, lines 7-11). Furthermore, Knowlton teaches that the processor can calculate the time pain has occurred (Paragraph 0166, lines 1-29) based on the beginning of a specific pulse irradiated at the time the pain has occurred (Paragraph 0178, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prouza to incorporate the teachings of Knowlton to include that the processor is configured to: collect information whether a pain has occurred and when the pain has occurred while irradiating pulses to a patient during the reference cycle; and calculate a specified time point of a beginning of a specific pulse irradiated at the time the pain has occurred, based on the collected information. Doing so would allow a medical provider to use a patient’s perceived pain during a skin treatment to more rapidly and precisely control the delivery of energy to a selected tissue site so as to not induce further pain for the patient (Paragraph 0178), as recognized by Knowlton.
Prouza also does not teach that the first pulse has an intensity that is lower than a maximum intensity of the pulse irradiated at the calculated specified time point. Knowlton, however, teaches a method for treatment of tissue with feedback that uses an apparatus (Fig. 1, Paragraph 0083, line 1) that includes a processor (Paragraph 0087, line 11) with a database. Knowlton teaches that the database can determine what intensity of RF energy is irradiated at the time pain has occurred for a patient (Paragraph 0178, lines 1-5). The apparatus can then ensure that energy irradiated in the first interval will be below the maximum intensity that is irradiated at the time pain occurred (Paragraph 0185, lines 1-7). Furthermore, Knowlton teaches that once pain occurs, the energy levels supplied by the energy delivery device can be decreased during the second interval (Paragraph 0178, lines 10-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prouza to incorporate the teachings of Knowlton to include that the first pulse has an intensity that is lower than a maximum intensity of the pulse irradiated at the calculated specified time point. Doing so would allow a medical provider to use a patient’s perceived pain during a skin treatment to more rapidly and precisely control the delivery of energy to a selected tissue site so as to not induce further pain for the patient (Paragraph 0178), as recognized by Knowlton.
Prouza also does not explicitly teach that the second pulse has an intensity that is lower than the intensity of the first pulse or is progressively lower from the intensity of the first pulse. Knowlton teaches a method for treatment of tissue with feedback that uses an apparatus (Fig. 1, Paragraph 0083, line 1) that can determine whether and when a pain has occurred for a patient (Paragraph 0150, lines 7-11). Furthermore, Knowlton teaches that once pain occurs, the energy levels supplied by the energy delivery device can be decreased (Paragraph 0178, lines 10-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prouza to incorporate the teachings of Knowlton to include that the second pulse has an intensity that is lower than the intensity of the first pulse or is progressively lower from the intensity of the first pulse. Doing so would reduce patient pain and discomfort during or after a tissue treatment, as well as reduce the incidence of unwanted tissue injury including thermal injuries and burns (Paragraph 0078), as recognized by Knowlton.
It also would be well known by a person of ordinary skill in the art that as skin temperature increases in the first interval, as shown in Figure 3 of Prouza, pulses with one energy are irradiated. It would also be well known by a person of ordinary skill in the art that as skin temperature decreases in the second interval, as shown in Figure 3 of Prouza, pulses with a lower energy are irradiated, since skin temperature has a direct and positive correlation with increased RF energy intensity.
Regarding claim 2, Prouza in view of Knowlton discloses the claimed invention
of claim 1. Prouza further discloses the pain relief (Paragraph 0023, lines 15-16) device (Fig. 1, Paragraph 0104, line 1) of claim 1, further comprising: a temperature sensor (Paragraph 0235, line 15) configured to measure a temperature of a treated portion of the skin (Paragraph 0139, lines 1-13), wherein the processor (Paragraph 0035, lines 4-6, Paragraph 0156, lines 9-11, and Paragraph 0274, lines 13-14) is configured to: monitor a change in the temperature of the treated portion of the skin through the temperature sensor (Paragraph 0427, lines 10-13); and when the temperature of the treated portion (Paragraph 0423, lines 4-6) is higher than a preset threshold (Paragraph 0428, lines 7-8), control the temperature of the treated portion to be lowered (Paragraph 0131, lines 5-10 and Paragraph 0428, lines 7-15).
Regarding claim 3, Prouza in view of Knowlton discloses the claimed invention of claim 2. Prouza further discloses the pain relief (Paragraph 0023, lines 15-16) device (Fig. 1, Paragraph 0104, line 1) of claim 2, wherein the electrode part (Fig. 4, Paragraph 0142, line 1) includes a plurality of electrodes (Paragraph 0147, line 7), wherein the processor (Paragraph 0035, lines 4-6, Paragraph 0156, lines 9-11, and Paragraph 0274, lines 13-14) is configured to control energy supply (Paragraph 0037, lines 1-3) to some or all of the plurality of electrodes (Paragraph 0326, line 9) during the reference cycle (Paragraph 0045, lines 8-9) based on the change in the temperature of the treated portion of the skin (Paragraph 0427, lines 10-13).
Regarding claim 8, Prouza teaches the pain relief (Paragraph 0023, lines 15-16) device (Fig. 1, Paragraph 0104, line 1) of claim 1. Prouza does not teach that the processor is configured to collect the information via a pressing input, touching input, or a voice input from the patient.
Knowlton, however, teaches a method for treatment of tissue with feedback that uses an apparatus (Fig. 1, Paragraph 0083, line 1) with a user input part (Paragraph 0150, lines 4-5). Knowlton specifies that the user input part can be a mechanical button (Paragraph 0150, line 14) that is activated by being pressed or touched by the user, a touchscreen (Paragraph 0150, line 14) that is activated by direct contact with a part of the user’s body, and a voice recognition module (Paragraph 0150, line 16) configured to recognized a user’s voice to extract pain-related information (Paragraph 0169, lines 30-33). Furthermore, Knowlton teaches the user input part transmits pain information to a processor (Paragraph 0166, lines 1-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prouza to incorporate the teachings of Knowlton to include that the processor is configured to collect the information via a pressing input, touching input, or a voice input from the patient. Doing so would allow a medical provider to use a patient’s perceived pain during a skin treatment to more rapidly and precisely control the delivery of energy to a selected tissue site (Paragraph 0178), as recognized by Knowlton.
Conclusion
THIS ACTION IS MADE FINAL. 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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/H.A.H./Patent Examiner , Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
