DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
The Amendment filed 02/27/2026 has been entered.
Claims 8 and 9 were cancelled.
Claims 1-7 and 10-19 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 11/07/2025.
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 1-5, 7, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (U.S. Patent Pub. 20150088050) hereinafter Chang, and further in view of Sedic et al. (U.S. Patent Pub. 20170056145), hereinafter Sedic.
Regarding claim 1, Chang discloses a handheld microneedling device (device 100; see FIGS. 1, 14, and 15; the Examiner notes that all reference characters cited below refer to FIGS. 1, 14, and 15 unless otherwise stated) for local stimulation of a skin (“FIG. 14 illustrates a further modification of the tip 404 that detachably couples to the handle 102. The tip 404 is a micro-needle skin treating tip”, [0115]) comprising:
a housing (body of handle 102);
a skin stimulation device (tip 404);
a drive device (vibrator 432) arranged in the housing (“Within either the interior 118 of the device, electronic control circuitry 138 may be positioned”, [0055]; see connection of circuitry 138 and vibrator 432 in FIG. 14) and adapted to provide a driving force (vibration force, see [0116]),
a microneedling stimulation tool (micro-needle assembly 430) formed on the skin stimulation device and connected to the driving device such that the microneedling stimulation tool is movable back and forth at a repetition frequency by the driving force when the driving force is in operation (“vibrator 432 will generate a vibration force to vibrate the micro-needles 431, so that the micro-needles 431 will drive to reciprocatingly move and puncture into the skin surface.”, [0116]); and
a needle plate (skin applying surface, see [0115-0117]) formed on the microneedling stimulation tool (see FIG. 14), and in which a plurality of non-piercing stimulation needles (micro-needles 431) having a blunt needle tip are arranged distributed over a front-side application surface (“skin applying surface, wherein the outer structure 242, intermediate structure 444, and the inner structure 246 are coaxial with each other and are formed at the slanted skin applying surface”, [0115]; see FIG. 14);
wherein the microneedling stimulation tool is movable back and forth by means of the driving force at the repetition frequency between a front working position and a rear working position which is set back in comparison thereto (“vibrator 432 will generate a vibration force to vibrate the micro-needles 431, so that the micro-needles 431 will drive to reciprocatingly move and puncture into the skin surface.”, [0116]), and
wherein the skin stimulation device is selectively releasably arranged on the housing (“The multi-functional tip 204, the electrode skin treating tip 304, and the micro-needle skin treating tips 404, 504 are interchangeable.”, [0121]).
However, Chang does not expressly state the drive device being configured to be selectively releasably coupled to the skin stimulation device or to a toothbrush head, each operable by the same drive device.
Sedic teaches a toothbrush device (Abstract) wherein the drive device (motor 101) is configured to be selectively releasably coupled to the skin stimulation device (“the electric toothbrush 100 has a head portion 460 and a handle portion 470, which are connected by a decorative ring 480 (corresponding to the decorative ring 104 in FIG. 1) for an electric toothbrush (electric toothbrush 100), which. The head can be detached from the handle portion at the location of the decorative ring 480”, [0029]; the Examiner notes [0026] and FIG. 1 demonstrate the ring 104 and brush 105 have a fastened connected, meaning they can be unfastened. The Examiner is of the position this is sufficient disclosure to teach or suggest the toothbrush being “selectively releasably coupled” as claimed) or to a toothbrush head (brush support 105 and brush head case 106), each operable by the same drive device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drive device of Chang to be configured to be selectively releasably coupled to the skin stimulation device or to a toothbrush head, each operable by the same drive device. Doing so provides a brush head capable of using vibration energy from a vibration motor in a controlled direction, as taught by Sedic (see [0020]).
Regarding claim 2, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches wherein, when moving between the front working position and the rear working position, at least the plurality of non-piercing stimulation needles of the needle plate in the front working position and the rear working position of the microneedling stimulation tool are arranged completely outside the housing and are thus exposed (“micro-needle assembly 430 further comprises a needle leveling adjustor 433 provided at the sidewall of the tip 404, wherein the level of depth of the micro-needles 431 can puncture the skin will be adjusted by the needle leveling adjustor 433.”, [0116]; the Examiner notes paragraph [0120] wherein adjustment of the needle via adjustor 433 can allow the needles to be exposed as to puncture the skin or remain unexposed and unable to puncture skin.).
Regarding claim 3, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches wherein, in operation, at least the front-side application surface is further arranged completely outside the housing (see FIG. 14) and thus exposed both in the front working position and in the retracted rear working position of the microneedling stimulation tool (the Examiner notes that the “skin applying surface” forms the outer structure 242, intermediate structure 444, the inner structure 246, and abrading structure 232 which are all arranged outside of the bodies of handle 102; see FIG. 14).
Regarding claim 4, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches wherein the needle plate (skin applying surface, see [0115-117]) is formed free of a housing portion of the housing at least partially surrounding the needle plate (The Examiner notes skin applying surface is formed on tip 404, free of handle 102; see FIG. 14).
Regarding claim 5, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches wherein the front-side application surface (“skin applying surface, wherein the outer structure 242, intermediate structure 444, and the inner structure 246 are coaxial with each other”, [0115]) with the plurality of non-piercing stimulation needles distributed thereon, at least in the front working position, is inclined (“slanted skin applying surface”, [0115]) with respect to a reference direction, wherein the reference direction is selected from the group consisting of: a longitudinal direction of the housing, a direction of movement of the microneedling stimulation tool when shifting between the front and the rear retracted working positions, and a direction of movement of the needle plate when shifting between the front and the rear retracted working positions (See FIG. 14).
Regarding claim 6, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, however, the embodiment of FIG. 14 of Chang does not expressly state a protective cap which is selectively releasably arranged on the housing covers the needle plate, a functional tool being arranged on the protective cap on the outside.
Chang teaches an alternative embodiment in FIG. 16 wherein a protective cap (cap 626) which is selectively releasably arranged on the housing (see [0123]) covers the needle plate (see FIG. 16), a functional tool (edge 618) being arranged on the protective cap on the outside (see FIG. 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the embodiment in FIG. 14 of Chang to include a protective cap which is selectively releasably arranged on the housing covers the needle plate, a functional tool being arranged on the protective cap on the outside. Doing so provides a detectable cap with a functional edge for applying pressure on the skin for pressure 5, as taught by the embodiment of Chang in FIG. 16 (see [0123]).
Regarding claim 7, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches wherein the housing is formed with a front housing part (front end of handle 102) and a rear housing part, wherein the front housing part is part of the skin stimulation device (the Examiner notes handle 102 and tip 404 engage with each other), is of sleeve-shaped design (see FIG. 1A) at the rear and at least partially encloses the rear housing part (the Examiner notes FIGS. 1B and 3A wherein handle 102 has an internal recess around the edge for receiving tip 104, wherein the end of the tip that is received is partially enclosed by handle 102. This design is the same for the other tip embodiments including 404), the drive device (vibrator 432) being disposed in the rear housing part (see FIGS. 1A-1B).
Regarding claim 13, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches comprising a reusable drive module (interior 118 of the device having control circuitry 138) in which the drive device (vibrator 432) is arranged (see FIG. 14), and a disposable module which is selectively releasably connected to the drive module (the Examiner notes the interchangeable tips demonstrate a connection with selective releasability) and in which the skin stimulation device (tip 404) is arranged (see FIG. 14).
Regarding claim 14, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches wherein the drive device (vibrator 432) is arranged to move the microneedling stimulation tool (micro-needle assembly 430) back and forth in operation at a repetition frequency (“micro-needle assembly 430 is another embodiment structure to penetrate fluid delivered through the skin that further comprises a vibrator 432 supported in the tip 404. The vibrator 432 is connected to the control circuit 138 and is linked to the micro-needles 431. During operation, the vibrator 432 will generate a vibration force to vibrate the micro-needles 431, so that the micro-needles 431 will drive to reciprocatingly move”, [0116]). However, Chang does not expressly state wherein the drive device is in operation at a repetition frequency between about 10 Hz and about 200 Hz by means of the driving force applied thereto.
Sedic teaches a toothbrush device (Abstract) wherein the drive device is arranged to move the stimulation (brush head 106 and brush support 105) tool back and forth in operation at a repetition frequency between about 10 Hz and about 200 Hz by means of the driving force applied thereto (“The high-frequency of the vibration motor 101 may provide oscillations between 50 and 300 Hz; the low-frequency of the vibration motor 101 provides oscillations in the 50-130 Hz range”, [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drive device of Chang to be arranged to move the microneedling stimulation tool back and forth in operation at a repetition frequency between about 10 Hz and about 200 Hz by means of the driving force applied thereto. Doing so provides a brush head capable of using vibration energy from a vibration motor in a controlled direction, as taught by Sedic (see [0020]).
Regarding claim 15, Chang discloses a skin stimulation device (tip 404) having a housing (body of handle 102) and being couplable to a drive device supported within a housing for forming a handheld microneedling device, the drive device adapted to provide a driving force (vibration force, see [0116]), comprising:
a microneedling stimulation tool (micro-needle assembly 430) formed on the skin stimulation device and connectable to the drive device such that the microneedling stimulation tool is movable back and forth at a repetition frequency by the driving force provided by the drive device (“vibrator 432 will generate a vibration force to vibrate the micro-needles 431, so that the micro-needles 431 will drive to reciprocatingly move and puncture into the skin surface.”, [0116]); and
a needle plate (skin applying surface, see [0115-117]) formed on the microneedling stimulation tool, and wherein a plurality of non-piercing stimulation needles (micro-needles 431) having a blunt needle tip are arranged distributed over a front-side application surface (“skin applying surface, wherein the outer structure 242, intermediate structure 444, and the inner structure 246 are coaxial with each other and are formed at the slanted skin applying surface”, [0115]; see FIG. 14);
wherein the microneedling stimulation tool is movable back and forth between a front working position and a rear working position which is set back in comparison thereto (“vibrator 432 will generate a vibration force to vibrate the micro-needles 431, so that the micro-needles 431 will drive to reciprocatingly move and puncture into the skin surface.”, [0116]), and wherein at least the plurality of non-piercing stimulation needles of the needle plate are arranged completely outside the housing and thus exposed in the front working position and the rear working position of the microneedling stimulation tool (“micro-needle assembly 430 further comprises a needle leveling adjustor 433 provided at the sidewall of the tip 404, wherein the level of depth of the micro-needles 431 can puncture the skin will be adjusted by the needle leveling adjustor 433.”, [0116]; the Examiner notes paragraph [0120] wherein adjustment of the needle via adjustor 433 can allow the needles to be exposed as to puncture the skin or remain unexposed and unable to puncture skin.). However, Chang doesn’t expressly state the drive device configured to be selectively releasably coupled to the skin stimulation device or to a toothbrush head, each operable by the same drive device.
Sedic teaches a toothbrush device (Abstract) wherein the drive device (motor 101) is configured to be selectively releasably coupled to the skin stimulation device (“the electric toothbrush 100 has a head portion 460 and a handle portion 470, which are connected by a decorative ring 480 (corresponding to the decorative ring 104 in FIG. 1) for an electric toothbrush (electric toothbrush 100), which. The head can be detached from the handle portion at the location of the decorative ring 480”, [0029]; the Examiner notes [0026] and FIG. 1 demonstrate the ring 104 and brush 105 have a fastened connected, meaning they can be unfastened. The Examiner is of the position this is sufficient disclosure to teach or suggest the toothbrush being “selectively releasably coupled” as claimed) or to a toothbrush head (brush support 105 and brush head case 106), each operable by the same drive device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drive device of Chang to be configured to be selectively releasably coupled to the skin stimulation device or to a toothbrush head, each operable by the same drive device. Doing so provides a brush head capable of using vibration energy from a vibration motor in a controlled direction, as taught by Sedic (see [0020]).
Regarding claim 16, Chang discloses a kit (see kit in [0019]), comprising:
a drive device (vibrator 432) disposed in a housing (body of handle 102; “Within either the interior 118 of the device, electronic control circuitry 138 may be positioned”, [0055]; see connection of circuitry 138 and vibrator 432 in FIG. 14); and
a skin stimulation device (tip 404) selectively releasably connectable to the housing (“The multi-functional tip 204, the electrode skin treating tip 304, and the micro-needle skin treating tips 404, 504 are interchangeable.”, [0121]) to thereby couple the skin stimulation device to the drive device to define a microneedling device (micro-needle assembly 430).
However, Chang does not expressly state a toothbrush head selectively releasably connectable to the housing to thereby couple the toothbrush head to the drive device to define an electric toothbrush
Sedic teaches a toothbrush head selectively releasably connectable to the housing to thereby couple the toothbrush head to drive device to define an electric toothbrush (“the electric toothbrush 100 has a head portion 460 and a handle portion 470, which are connected by a decorative ring 480 (corresponding to the decorative ring 104 in FIG. 1) for an electric toothbrush (electric toothbrush 100), which. The head can be detached from the handle portion at the location of the decorative ring 480”, [0029]; the Examiner notes [0026] and FIG. 1 demonstrate the ring 104 and brush 105 have a fastened connected, meaning they can be unfastened. The Examiner is of the position this is sufficient disclosure to teach or suggest the toothbrush being “selectively releasably coupled” as claimed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Chang to include a toothbrush head selectively releasably connectable to the housing to thereby couple the toothbrush head to the drive device to define an electric toothbrush. Doing so provides a brush head capable of using vibration energy from a vibration motor in a controlled direction, as taught by Sedic (see [0020]).
Regarding claim 17, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, and Chang further teaches
wherein the housing is formed with a front housing part (front end of handle 102) and a rear housing part,
wherein the drive device (vibrator 432) is disposed in the rear-housing part (see FIGS. 1A-1B),
wherein the front housing part is part of the skin stimulation device (the Examiner notes handle 102 and tip 404 engage with each other), and
wherein the needle plate is arranged on the front housing part (see skin applying surface in [0115-0117] and FIG. 7),
Regarding claim 18, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 17, and Chang further teaches wherein the needle plate is integrally molded to the front housing part such that the front housing part forms the needle plate (“In the preferred embodiment, the outer structure 242, intermediate structure 244, and the inner structure 246 are integrated with the tip 204 at the skin applying surface.”, [0110]; see FIG. 7).
Regarding claim 19, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 18, and Chang further teaches wherein the non- piercing stimulation needles (microneedles 431) are integrally formed on the needle plate (see [0115]).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (U.S. Patent Pub. 20150088050) hereinafter Chang, and further in view of Sedic et al. (U.S. Patent Pub. 20170056145), hereinafter Sedic. and further in view of O'Brien et al. (U.S. Patent Pub. 20170354810), hereinafter O'Brien.
Regarding claim 10, Chang in view of Sedic teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Chang in view of Sedic does not expressly state wherein the microneedling stimulation tool can be displaced through an opening at a front-side housing end of the housing into a non-working position which is further set back compared to the set-back rear working position and in which at least the front-side application surface of the needle plate is set back relative to the opening.
O'Brien teaches a transdermal microneedling devices (Abstract) wherein the microneedling stimulation tool (needle unit 215 and needles 215a) can be displaced through an opening (opening of sleeve 210) at a front-side housing end (distal end 210a) of the housing (sleeve 210 and base portion 205) into a non-working position which is further set back compared to the set-back rear working position and in which at least the front-side application surface of the needle plate (surface of distal end of needle unit 215) is set back relative to the opening (“depth adjustment sleeve 210 to the base portion 205 allows a user to precisely adjust the maximum distance the needles 215a of the needle unit 215 will longitudinally extend beyond the distal end 210a of the depth adjustment sleeve 210”, [0039]; the Examiner notes user adjustment displaces the microneedle tool to and from a working and nonworking position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Chang in view of Sedic wherein the microneedling stimulation tool can be displaced through an opening at a front-side housing end of the housing into a non-working position which is further set back compared to the set-back rear working position and in which at least the front-side application surface of the needle plate is set back relative to the opening. Doing so provides an microneedling tool that is adjustable to provide precise depth control, as taught by O’Brian (see [0038-0039]).
Regarding claim 11, Chang in view of Sedic in view of O’Brian teaches the claimed invention as discussed above concerning the rejection of claim 10, and O’Brian further teaches wherein the needle plate (surface of distal end of needle unit 215) is spaced on one or more sides from an edge (edge of sleeve 210) surrounding the opening during displacement through the opening (See FIG. 2).
Regarding claim 12, Chang in view of Sedic in view of O’Brian teaches the claimed invention as discussed above concerning the rejection of claim 10, and O’Brian further teaches wherein the needle plate (surface of distal end of needle unit 215) in the further retracted non-working position is arranged to be exposed at a distance from housing portions of the housing surrounding the needle plate (“depth adjustment sleeve 210 to the base portion 205 allows a user to precisely adjust the maximum distance the needles 215a of the needle unit 215 will longitudinally extend beyond the distal end 210a of the depth adjustment sleeve 210”, [0039]; the Examiner notes user adjustment displaces the microneedle tool to and from a working and nonworking position).
Response to Arguments
Applicant’s arguments, see Remarks, filed , 02/27/2026 with respect to the rejection(s) of claim(s) 1-16 under 35 U.S.C. 102 over Chang (20150088050) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 over Chang (20150088050) in view of Sedic (20170056145).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
06/27/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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