DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 (i.e., changing from AIA to pre-AIA ) 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.
Drawings
3. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “guide holes” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
4. 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.
5. The drawings are objected to under 37 CFR 1.83(a) because they fail to show the “fixing assembly”, reference number 4, as described in the specification (see para 0037, 0038, 0041, 0042, 0043, 0044, 0045). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 Rejections - 35 USC § 112
6. 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.
7. Claim 5, as well as claims 6-9 based on their dependency to the former claim, 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.
8. Claim 5 recites the limitation "connected with each other" in line 2. It is unclear what “each other” is referring to, for example whether the adapter board body and connecting member are connected to one another, or if only the remainder of the claim is true, or if both are true. This renders the claim indefinite. Proper correction is required.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1, 2, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lei U.S. 2018/0271589 (herein referred to as “Lei”) and in view of An U.S. 2020/0094046 (herein referred to as “An”).
11. Regarding Claim 1, Lei teaches a treatment tip for a high-frequency skin treatment device irradiating radio frequency (RF) (para 0046; Fig. 1), the tip being coupled to a handpiece to radiate an RF signal to a human skin in an invasive way (Fig. 1, ref num 10; para 0046), and comprising:
a. a needle plate portion (Fig. 3, ref num 31), having a plurality of needles (Fig. 3, ref num 32);
b. an adapter board portion (Fig. 1, proximal portion of ref num 10); and
d. wherein in relation to the adapter board portion, the needle plate portion is driven to move forth at a first position where the plurality of needles penetrate and radiate the RF signal into the skin; and the needle plate portion is driven to move back at a second position where the plurality of the needles to move away from the skin (para 0063, “the treatment device body 200 includes a drive portion for sliding the microneedle device to the left and right… The pushrod can cross the installation port 13 in the left and right sides through an electric motor to move back and forth, so as to push the microneedle base 31 to slide to the left and right. Thus the microneedles 32 can extend from and retract to the pinholes 212”).
Lei fails to teach (c) a first flexible printed circuit, mechanically and electrically coupled between the needle plate portion and the adapter board portion; and (e) wherein the plurality of needles are partitioned and controlled such that the RF signal from the handpiece is transmitted sequentially through the adapter board portion, the first flexible printed circuit and the needle plate portion to the partitioned plurality of the needles that radiate the RF signal to different zones of the skin.
An teaches a treatment device of analogous art (Fig. 5), wherein the device comprises a treatment tip comprising a first flexible printed circuit (Fig. 5, ref num 501 and 502; para 0061, “the first conductive member 501 and the second conductive member 502 may be flexible printed circuit boards (FPCBs)”), mechanically and electrically coupled between a needle plate portion and the adapter board portion (Fig. 5, ref num 501/502 are connected between ref num 630 and 503; para 0061, 0065), such that the plurality of needles are partitioned and controlled such that the RF signal from the handpiece is transmitted through the adapter board portion, the first flexible printed circuit and the needle plate portion to the partitioned plurality of the needles that radiate the RF signal to different zones of the skin (para 0069, “The plurality of needle electrodes 610 may include a first group 611 of needle electrodes and a second group 612 of needle electrodes to which a current is applied at different times. In other words, according to the inventive concept, the plurality of needle electrodes 610 in the needle tip 600 may be divided into two or more groups, and a current may be alternately applied to the two or more groups (alternating oscillation)”; para 0065). The flexible printed circuit facilitates the movement of the needles in a vertical direction (para 0061), as well as provides the RF signal to the needle portion for treatment (para 0069). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lei to have included the first flexible printed circuit, as this provides the same expected result of moving the needles forward and backward, as well as providing the treatment signal to the needles.
Lei as modified fails to specifically teach that the RF signal is transmitted sequentially through the adapter board portion, the first flexible printed circuit, and the needle plate portion. However, it is understood that the RF signal is transmitted first through a power module (An, Fig. 4, ref num 400) sequentially to the needle plate portion (Fig. 5, ref num 600; para 0054-0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified An to have the RF signal transmitted sequentially as this achieves the same expected result of delivering the RF signal to the needles.
12. Regarding Claim 2, Lei fails to teach a fixing assembly configured to mechanically couple the first flexible printed circuit between the needle plate portion and the adapter board portion.
An teaches a fixing assembly configured to mechanically couple the first flexible printed circuit between the needle plate portion and the adapter board portion (see Fig. 5, ref num 500 has a fixing assembly that couples ref num 503 to ref nums 501/502 and 600). The flexible printed circuit facilitates the movement of the needles in a vertical direction (para 0061), as well as provides the RF signal to the needle portion for treatment (para 0069). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lei to have included a fixing assembly to mechanically couple the first flexible printed circuit to the other structures, as this provides the same expected result of moving the needles forward and backward, as well as providing the treatment signal to the needles.
13. Regarding Claim 10, Lei teaches a housing (Fig. 2, ref num 10), the housing comprising a receiving cavity with an opening (Fig. 2, ref num 11); and a plurality of needle holes disposed at a bottom of the receiving cavity (Fig. 2, ref num 212); wherein the needle plate portion, the adapter board portion and the first flexible printed circuit are disposed in the receiving cavity (Fig. 2, it is understood all of these structures would be disposed within ref num 11), the adapter board portion is fixed to the housing (Fig. 2, the proximal portion of ref num 10 is fixed to ref num 10), and each needle is driven to move inwards or outwards of the needle hole (Fig. 2, ref num 32 is driven inwards/outwards of ref num 212; para 0048).
14. Regarding Claim 11, Lei teaches a negative pressure tube (Fig. 1, ref num 41); and a suction assembly (Fig. 4, ref num 251); wherein the negative pressure tube is provided on an outer peripheral wall of the housing and is communicated with the receiving cavity (Fig. 2, ref num 41 is on outer wall of housing and communicated with ref num 11; para 0056), and one end of the suction assembly is connected to the negative pressure tube (Fig. 4, ref num 251 is connected to ref num 41; para 0064).
15. Regarding Claim 12, Lei fails to teach the housing comprises transparent materials. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the housing comprise of transparent materials, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
16. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lei and An, and further in view of Park U.S. 2026/0069345 (herein referred to as “Park”).
17. Regarding Claim 3, Lei teaches the needle plate portion comprises a needle plate body and a guide member (Fig. 3, ref num 31 comprises a plate body and ref num 21 is a guide member; also see Fig. 2), and the plurality of needles are installed on the needle plate body (Fig. 2, ref num 32 are installed on ref num 31).
Lei fails to teach the needle plate body is coupled with the first flexible printed circuit, and a plurality of guide holes are provided on the adapter board portion; one end of the guide member is connected to the needle plate body, and the other end of the guide member passing through the guide holes is slidably connected to the adapter board portion.
Park teaches a device of analogous art (Figs. 1 and 6), wherein the device comprises an adapter board portion (Fig. 6, ref num 297) with a plurality of guide holes (Fig. 6, ref num 298, 299; para 0110), and a needle plate body (Fig. 6, ref num 210, 220), such that the needle plate body is coupled with a flexible printed circuit (Fig. 6, ref num 240). The needle plate body comprises a guide member (Fig. 5, ref num 428), with one end of the guide member connected to the needle plate body (see Fig. 5, ref num 428 is connected to plate, ref num 410), and the other end of the guide member passing through the guide holes is slidably connected to the adapter board portion (it is understood that the other end of ref num 428 would pass through the guide holes). The guide member acts to connect the needles to the RF signal provided (para 0104), and the guide holes determine the depth of penetration of the needles in order to provide the treatment to the tissue (para 0110). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lei to include guide holes in the adapter board portion in order to guide the needles to the proper depth for treatment of the skin.
18. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lei and An, and further in view of Park and Kang U.S. 2022/0395393 (herein referred to as “Kang”).
19. Regarding Claim 4, Lei fails to teach the fixing assembly comprising a first fixing plate and a first fastener, and a first end of the first flexible printed circuit is disposed between the first fixing plate and the guide member, a first opening is provided on the first fixing plate, and the first fastener is connected to the guide member by passing through the first opening.
Kang teaches a fixing assembly (Fig. 3, ref num 200) comprising a first fixing plate (Fig. 3, ref num 210) and a first fastener (Fig. 3, ref num 210), and first end of the connection terminal is disposed between the first fixing plate and a guide member (Fig. 5, ref num 22 is disposed between ref num 210 and ref num 220), a first opening is provided on the first fixing plate, and the first fastener is connected to the guide member by passing through the first opening (see Fig. 5, ref num 142 passes through openings of ref num 211 in order to connect ref num 220). This aids with the position of the needles, and ultimately, the penetration into the tissue (para 0063). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lei to have included the fixing assembly in order to facilitate with the positioning of the needles.
20. Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lei and An, and further in view of Ahn U.S. 2022/0409898 (herein referred to as “Ahn”).
21. Regarding Claim 13, Lei as modified teaches a hand tool (Lei, Fig. 4) comprising a handpiece (Lei, see Fig. 4, ref num 200; para 0063, “treatment device 200 is set to a handle shape”); and the treatment tip of claim 1 (see rejection of claim 1 above); wherein the treatment tip is detachably connected to the handpiece (para 0063, “treatment device body 200 is detachably connected with the microneedle treatment head 100”); the handpiece comprises a driving end (Fig. 2, ref num 220) driving the needle plate portion to move forth at a first position where the plurality of needles penetrate and radiate the RF signal into the skin, and driving the needle plate portion to move back at a second position where the plurality of the needles to move away from the skin (para 0063).
Lei fails to teach the handpiece comprises a second flexible printed circuit, and the second flexible printed circuit is electrically connected to the treatment tip to allow the handpiece to radiate RF energy to the treatment tip.
Ahn teaches a hand tool of analogous art (Fig. 1, 2, 4), wherein the hand tool comprising handpiece (ref num 200) that comprises a second flexible printed circuit (Fig. 4, ref num 220; para 0069), the second flexible printed circuit is electrically connected to a treatment tip to allow the handpiece to radiate RF energy to the treatment tip (Abstract, “The handpiece body includes: a connection PCB to which a connection member configured to be electrically connected to the needle PCB is coupled; and a connection PCB cable configured to be electrically connected to the connection PCB”; para 0012, “a handpiece body having a first end detachably connected to a second end of the needle body, wherein the handpiece body comprises: a connection PCB to which a connection member configured to be electrically connected to the needle PCB is coupled; and a connection PCB cable configured to be electrically connected to the connection PCB”). This achieves the expected result of providing the desired treatment to the target tissue (para 0006, 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lei to include a second flexible printed circuit in the handpiece to facilitate transfer of energy to the treatment tip and target tissue.
22. Regarding Claim 14, Lei fails to teach the second flexible printed circuit comprises an adapter unit a first control unit and a second control unit, and the adapter unit, the first control unit and second control unit are integrally formed.
Ahn teaches the second flexible printed circuit comprises an adapter unit (Fig. 4, ref num 240), a first control unit and a second control unit, and the adapter unit, the first control unit and second control unit are integrally formed (para 0045, “the connection member 210 may include a first connection member 211 and a second connection member 212”). This achieves the expected result of providing the desired treatment to the target tissue (para 0006, 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lei to include a second flexible printed circuit in the handpiece to facilitate transfer of energy to the treatment tip and target tissue.
23. Regarding Claim 15, Lei as modified teaches a high-frequency skin treatment device (Fig. 4), comprising the hand tool of claim 13 (see Claim 13 rejection above).
Allowable Subject Matter
24. Claims 5-9 contain allowable subject matter.
25. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
26. Claims 5-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
27. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights