DETAILED ACTION
The following is a 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/27/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 3/27/2026.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments are 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: indent lls. 15 & 17 one more time. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: delete ll. 4-5 as they are duplicates of lls. 2-3. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 4 is objected to because of the following informalities: amend “and a decreasing” to -or a decreasing- in ll. 8. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: amend “moving” to -move- in ll. 11. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the controlling” to -controlling- in ll. 5. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the first” to -a first- in ll. 9. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the second” to -a second- in ll. 10. 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.
Claim 11 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 11 recites “A radio-frequency microneedle therapy instrument”; however, claim 11 depends from claim 1, which also recites “a radio-frequency microneedle therapy instrument”. It is unclear how many instruments are being claimed. For purposes of examination, the claim will be interpreted as claiming only one instrument.
Claim Interpretation
Claim 1 recites “controlling the linear motor to drive movement…wherein the movement of the at least two microneedle electrodes comprises the at least two microneedle electrodes operably penetrating into the human body at the penetration depth and then moving back along the length direction from inside the human body to outside the human body”. The limitation “the length direction from inside the human body to outside the human body” will be interpreted as only a direction and not actual electrode movement to outside the human body.
Claim Rejections - 35 USC § 102
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) 1-6, 9 & 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wootten (WO2020/086552, previously cited).
Concerning claim 1, as illustrated in at least Fig. 1A-B, Wootten et al. disclose a microneedle therapy control method, applied to a radio-frequency microneedle therapy instrument (method of inducing collagen regeneration in the skin with microneedle electrode system 100 and adjusting probe parameters; [0014-0016]), wherein the radio-frequency microneedle therapy instrument comprises:
at least two microneedle electrodes movable along a length direction of the microneedle electrodes (microneedle array 110 may comprise one or more microneedles configured to be applied to penetrate skin when driven by motor 108 that drives microneedles 112 in a linearly reciprocating motion; [0029-0030]);
a power supply configured to supply radio-frequency energy for the at least two microneedle electrodes (interface 122 comprises power to the system 100 and/or the handpiece 102 for application of RF energy; [0044-0045]); and
a linear motor configured to drive the at least two microneedle electrodes to move (motor 108 that drives microneedles 112 simultaneously in a linearly reciprocating motion; [0030]), wherein the method comprises:
obtaining a penetration depth of the at least two microneedle electrodes (user can input penetration depth in step 204 or system can automatically adjust penetration depth; [0059], [0063]);
determining a movement range of the at least two microneedle electrodes in the length direction according to the penetration depth of the at least two microneedle electrodes; wherein determining the movement range of the at least two microneedle electrodes in the length direction according to the penetration depth of the at least two microneedle electrodes comprises: determining a minimum energy output depth of the at least two microneedle electrodes according to a target tissue; and determining the movement range of the at least two microneedle electrodes in the length direction to be between the penetration depth and the minimum energy output depth; (system can automatically adjust one or more penetration depth(s) in response to the delineated skin layers of measured thicknesses and the calculated size of coagulation volumes, where the system is configured to adjust the penetration depth(s) such that the anticipated coagulation volumes are confined to target layers of skin or otherwise located in relatively precise target volumes of skin for any given skin sector, such as confining the volume of coagulation to the dermis, thus the reciprocal motion/cycling is located within a confined skin layer between two more penetration depths in a regular pattern to achieve the desired coagulation volume, where one depth is taken to be the penetration depth, and the other penetration depth is taken to be the minimum energy output depth, [0059], [0061], [0063]);
wherein the method further comprises:
controlling the linear motor to drive movement of the at least two microneedle electrodes at a preset speed, and concurrently controlling the power supply to supply the radio-frequency energy to the at least two microneedle electrodes, enabling the at least two microneedle electrodes to output the radio-frequency energy within the movement range while moving at the preset speed within the movement range (system updates operating parameters of the array, including penetration depth, in step 212, where motor 108 drives each of the microneedles 112 simultaneously in a linearly reciprocating motion such that the microneedles 112 are inserted a known depth into the skin when the motor 108 reciprocates the microneedle array to achieve the desired coagulation volume; [0030], [0061], [0067]); and
wherein the movement of the at least two microneedle electrodes comprises the at least two microneedle electrodes operably penetrating into the human body at the penetration depth and then moving back along the length direction from inside the human body to outside the human body (treatment is initiated in step 214 where RF energy is delivered to microneedle array 110 and the motor 108 may cycle between two or more penetration depths below the skin surface in a regular pattern and energy is supplied at each penetration depth; [0031], [0058], [0061], [0067]).
Concerning claim 2, Wootten et al. disclose wherein concurrently controlling the power supply to supply the radio-frequency energy to the at least two microneedle electrodes comprises: controlling the power supply (122) to supply one of a first electric polarity or a second electric polarity for at least one of the at least two microneedle electrodes (112) and to supply another one of the first electric polarity and the second electric polarity for remaining microneedle electrodes (112) of the at least two microneedle electrodes ([0031], [0034]).
Claim 3 is rejected upon the same rationale as applied to claim 1.
Concerning claim 4, Wootten et al. disclose wherein concurrently controlling the power supply (122) to supply the radio-frequency energy to the at least two microneedle electrodes (112) comprises: determining a preset operating power mode of the power supply module (122) according to a mapping table between the target tissue and a preset operating power mode of the power supply (122), wherein the preset power mode comprises an increasing power mode, a constant power mode and a decreasing power mode; and controlling the power supply (122) to operate in the preset operating power mode and supply the radio-frequency energy to the microneedle electrode (112) while the at least two microneedles (112) move at the preset speed within the movement range ([0058]; Fig. 4).
Concerning claim 5, Wootten et al. disclose wherein before controlling the linear motor (108) to drive the movement of the at least two microneedle electrodes (112), the method further comprises: controlling the linear motor (108) according to the penetration depth to drive the at least two microneedle electrodes (112) to penetrate into the human body until needle tips of the at least two microneedle electrodes (112) reach the penetration depth; and controlling the power supply (122) to supply the radio-frequency energy to at least one electrode of the at least two microneedle electrodes (112) within a preset duration ([0032], [0058-0059], [0063]).
Concerning claim 6, Wootten et al. disclose the radio-frequency microneedle therapy instrument (100) further comprises a return electrode (remote ground electrode) arranged at a body surface, the return electrode (remote ground electrode) is electrically connected to the power supply (122); and controlling the power supply (122) to supply the radio-frequency energy to the at least one microneedle electrode of the at least two microneedle electrodes (112) within the preset duration comprises: controlling the power supply in a unipolar mode within the preset duration to supply the one of a first electric polarity or a second electric polarity for the at least two microneedle electrodes (remote ground electrode) and supply another one of the first electric polarity or the second electric polarity for the return electrode (remote ground electrode) ([0031]).
Concerning claim 9, Wootten et al. disclose wherein the obtaining the penetration depth of the microneedle electrode (112) comprises: obtaining the penetration depth of the microneedle electrode (112) according to a mapping table (program selection step 202) between the part to be treated and a preset penetration depth of the microneedle electrode (112) ([0008-0009], [0062], [0066]).
Concerning claim 11, as illustrated in at least Fig. 1A-B, Wootten et al. disclose a radio-frequency microneedle therapy instrument (microneedling system 100; [0028]), comprising:
the at least two microneedle electrodes movable along a length direction of the at least two microneedle electrodes (microneedle array 110 may comprise one or more microneedles configured to be applied to penetrate skin when driven by motor 108 that drives microneedles 112 in a linearly reciprocating motion; [0029-0030]);
the power supply module configured to supply radio-frequency energy for the at least two microneedle electrodes (interface 122 comprises power to the system 100 and/or the handpiece 102 for application of RF energy; [0044-0045]);
the linear motor configured to drive the at least two microneedle electrodes to move (motor 108 that drives microneedles 112 in a linearly reciprocating motion; [0030]); and
at least one processor, a memory, and a microneedle therapy control program stored in the memory and executable on the processor, wherein when executed by the at least one processor, wherein when the microneedle therapy control program is executed by the processor, the microneedle therapy control method of claim 1 is implemented (one or more processors and/or memory comprise software for operating the system according to preselected operating parameters and/or treatment protocols, including but not limited to controlling the motor 108, controlling the power supplied to the RF electrodes, controlling the signal generator generating ultrasound waves, and/or interpreting the output signals of the ultrasound transducer 120; [0045]).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wootten et al. (WO2020/086552, previously cited), as applied to claim 6, in further view of Lei (CN111529056, using US2023/0293221 as translation, previously cited).
Concerning claim 7, while Wootten et al. disclose the method to control energy delivery in both monopolar and bipolar modes (see claims 2 & 6), Wootten et al. fail to specifically disclose controlling the power supply to be in a bipolar mode during a conversion duration to supply the one of the first electric polarity and the second electric polarity for at least one of a plurality of microneedle electrodes and supply another one of the first electric polarity and the second electric polarity for the remaining microneedle electrodes of the plurality of the microneedle electrodes, the conversion duration is a part of the preset duration, and the unipolar mode and the bipolar mode are switched at least once within the preset duration. However, Lei et al. disclose a microneedle therapy control method comprising controlling a power supply (10) to be in a bipolar mode during a conversion duration to supply one of the first electric polarity and the second electric polarity for at least one of a plurality of microneedle electrodes (30) and supply another one of the first electric polarity and the second electric polarity for remaining microneedle electrodes of the plurality of the microneedle electrodes (30), the conversion duration is a part of the preset duration, and the unipolar mode and the bipolar mode are switched at least once within the preset duration. 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 Wootten et al. to further comprise controlling the power supply to be in a bipolar mode during a conversion duration to supply the one of the first electric polarity and the second electric polarity for at least one of a plurality of microneedle electrodes and supply another one of the first electric polarity and the second electric polarity for the remaining microneedle electrodes of the plurality of the microneedle electrodes, the conversion duration is a part of the preset duration, and the unipolar mode and the bipolar mode are switched at least once within the preset duration in order to provide the benefit of the action area of the microneedle having better treatment effect in a width horizontal to the skin and a depth perpendicular to the skin, which is beneficial to improve the uniformity of energy output as taught by Lei et al. ([0012-0016], [0038], [0061-0062]; Fig. 1 & 5)
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Wootten teaches “only one target depth is to be treated during each penetration, thus multiple insertions are required to treat multiple depths”, the Examiner respectfully disagrees. Wootten teaches “the motor 108 may cycle between two or more penetration depths in a regular pattern” ([0061]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “in the process of Wootten’s needles moving/passing/penetrating towards the target depth, no RF current is released” over the entire movement range while the electrodes move at the preset speed within the movement range) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner notes the claim recites “concurrently controlling the powers supply to supply the radio-frequency energy…[and] enabling the at least two microneedle electrodes to output the radio-frequency energy within the movement range while moving the preset speed within the movement range” which requires the needle to output energy at any point in time while it is moving within the movement range.
The Examiner notes to Applicant that the claims fail to recite: (1) supplying the RF energy to the electrodes for an entire duration of the movement range while the electrodes are moving at the preset speed within the movement range; and (2) the “minimum energy output depth” is a depth that is used for preventing the radio-frequency energy delivered by the microneedle electrode from burning the epidermis layer.
Conclusion
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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