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 .
Election/Restrictions
Claims 9-10 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 25 September 2025.
Applicant’s election without traverse of Group I: Claims 1-8 in the reply filed on 25 September 2025 is acknowledged.
Response to Amendment
This Office Action is responsive to the amendment filed 25 September 2025. As per the amendment: claims 9-10 have been withdrawn and no claims have been amended, added, or cancelled. Thus, claims 1-8 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 06/09/2022 and 03/20/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 6-7 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 6 recites the limitation "the sensor part” in line 2. There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to amend claim to recite “the sensor” as recited in claim 4 from which claim 6 depends.
Claim 7 recites the limitation “the other end of the needle body” in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner will interpret the other end of the needle body to be referencing either the first or second end of the needle body, as recited in claim 1 from which claim 7 depends.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-2, 5, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lee et al. (KR 2021/0045239 A, citations from attached NPL), hereinafter Choi (name of another inventor listed in the application) or, in the alternative, under 35 U.S.C. 103 as obvious over Choi in view of Lee (KR 2016/0111191 A1, citations from attached NPL), hereinafter Lee.
Regarding claim 1, Choi discloses an electric device for skin treatment (skin treatment device 100), the device comprising:
a needle body (needle module 300) including needles for drug injection and electrical stimulation treatment ([0026] “The needle module (300) may have a plurality of micro needles (355)”, [0027] “The needle module (300) can insert micro needles (355) into the user's skin under the control of the main body (200), and inject drugs into the user's skin or apply a predetermined electrical stimulation through the inserted micro needles (355)”) and a needle printed circuit board (PCB) connected to the needles ([0056] “A plurality of micro needles (355) can be attached to the lower surface of the fixed plate (353)”, [0057] “The second connection terminal (372) can transmit the electrical signal provided through the connection terminal (310) to the fixed plate (353). The fixed plate (353) can supply an electrical signal supplied through the second connection terminal (372) to each of the multiple micro needles (355) on its lower surface”);
a needle cap (second cover portion 360) provided at a first end of the needle body and having a needle hole through which the needles passes ([0059] “The second cover portion (360) can be placed on one side of the needle module (300). A plurality of holes may be formed in the second cover portion (360) to allow a plurality of micro needles (355) of the needle module (300) to be inserted and exposed to the outside.”); and
a handpiece body (main body 200) having a first end detachably connected to a second end of the needle body ([0026] “The needle module (300) may have a structure that is detachably coupled to one side of the main body (200).”, view Figure 1),
wherein the handpiece body comprises:
a connection PCB (output unit 230) to which a connection member (connection terminal 310) configured to be electrically connected to the needle PCB is coupled ([0071] “The high-frequency current output from the output unit (230) can be transmitted to a plurality of micro needles (355) connected to the fixed plate (353) by a current path through the connection terminal (310), the first connection terminal (371), the electrode plate (380), and the fixed plate (353).”); and
a connection PCB cable (predetermined connecting member 315) configured to be electrically connected to the connection PCB ([0047] “The high-frequency current output from the output unit (230) can be transmitted to a plurality of micro needles (355) connected to the fixed plate (353) by a current path through the connection terminal (310), the first connection terminal (371), the electrode plate (380), and the fixed plate (353).”).
Alternatively, Choi fails to disclose wherein the handpiece body comprises: a connection PCB (ground 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.
However, Lee (KR 2016/0111191 A1) teaches a handpiece for skin treatment capable of delivering drugs into the skin ([0001]) wherein the handpiece body comprises: a connection PCB to which a connection member (pogo pin 310) configured to be electrically connected to the needle PCB (needle PCB 200) is coupled ([0052] “The bottom surface of the needle PCB (200) may further be provided with a groove (not shown in the drawing) for connection with the pogo pin (310) of the ground PCB (300) described later, and this groove may have various shapes corresponding to the shape of the pogo pin (310) and the position change during the installation process.”, view Figure 5, [0059]); and a connection PCB cable (a pair of wires 320) configured to be electrically connected to the connection PCB ([0058] “a pair of wires (320) are provided on the lower part of the ground PCB (300) so as to be connected to a control unit (600) to be described later.”, [0057]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Choi to incorporate the teachings of Lee to have the handpiece body comprises: a connection PCB (ground 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, as these prior art references are directed to handheld skin treatment devices. One would be motivated to do this to be able to be able to control and deliver electricity to the needles, as recognized by Lee ([0014]).
Regarding claim 2, Choi (alternatively in view of Lee) discloses the electric device of claim 1 (as shown above). Choi further disclose wherein the needle body comprises a plated part (the electrode plate 380) disposed at the second end of the needle body and providing the needle with a current in contact with the connection member ([0060] “Additionally, an electrode plate (380) to which an electrical signal is applied may be disposed on the upper surface of the second cover portion (360), that is, on the surface corresponding to the lower surface of the fixing plate (353) of the needle module (300), by contacting each of the first connection terminal (371) and the second connection terminal (372). Of course, a plurality of holes into which a plurality of micro needles (355) are inserted can also be formed in the electrode plate (380).”, [0071] “The high-frequency current output from the output unit (230) can be transmitted to a plurality of micro needles (355) connected to the fixed plate (353) by a current path through the connection terminal (310), the first connection terminal (371), the electrode plate (380), and the fixed plate (353).”).
Regarding claim 5, Choi in view of Lee teaches the electric device of claim 2 (as shown above). Choi further discloses wherein the connection member comprises a first connection member (the first connection terminal 371) providing the needles with a current in contact with the plated part ([0046] “The connection terminal (310) can provide an electrical signal output from the output unit (230) to a plurality of micro needles (355) of the needle module (300) through one or more connection terminals to be described later, such as the first connection terminal (371) and the second connection terminal (372), respectively.”, [0060] “Additionally, an electrode plate (380) to which an electrical signal is applied may be disposed on the upper surface of the second cover portion (360), that is, on the surface corresponding to the lower surface of the fixing plate (353) of the needle module (300), by contacting each of the first connection terminal (371) and the second connection terminal (372).”).
Regarding claim 8, Choi (alternatively in view of Lee) discloses the electric device of claim 1 (as shown above), wherein the needles have different heights from each other ([0032] “The moving part (250) of the main body (200) can adjust the height of a plurality of micro needles (355) of the needle module (300) according to the control of the needle control part (260). Here, the height of the micro needle (355) may refer to the length to which a plurality of micro needles (355) protrude outside the needle module (300).”, [0077] “the skin treatment method of the present embodiment can increase the effectiveness of the skin treatment by adjusting the needle depth through the adjustment of the protrusion length of the micro needle (355), thereby enabling needles to be administered at an optimal depth according to the user's skin condition.” ).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Lee as applied to claim 2 above, and further in view of Marlin et al. (US Patent 10,561,800 B1), hereinafter Marlin.
Regarding claim 4, Choi in view of Lee discloses the electric device of claim 2 (as shown above). Choi and Lee, alone or in combination, fail to teach wherein the handpiece body further comprises a sensor configured to detect a contact between the user and the handpiece body.
However, Marlin teaches electrical and electro-mechanical skin sensor systems for drug delivery devices wherein the handpiece body further comprises a sensor (one or more skin sensors 655) configured to detect a contact between the user and the handpiece body (Column 10, line 61-Column 11, line 3: “Auto injector 50, for example, may include one or more skin sensors 665 that may be utilized to detect or sense contact or close proximity between distal face 210 of auto injector 50 and the patient's skin prior to activation of the automatic injector (i.e., prior to a drug delivery sequence) and/or during the drug delivery sequence. One or more electrodes of the skin sensor 665 may be positioned at the distal face 210 of the reusable automatic injector 50.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Choi and Lee to incorporate the teachings of Marlin to have the handpiece body further comprise a sensor configured to detect a contact between the user and the handpiece body, as these prior art references are directed to skin treatment devices. One would be motivated to do this to increase the safety of the user or operator by decreasing the risk of a needle-stick injury and decreases the likelihood of expelling the contents of a syringe unintentionally or inadvertently, as recognized by Marlin (Column 3, lines 24-28).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Lee as applied to claim 1 above, and further in view of Suh (KR 101122526 B1), hereinafter Suh.
Regarding claim 7, Choi (alternatively in view of Lee) discloses the electric device of claim 1 (as shown above). Although, Choi further discloses the needly body being insertable into a handpiece body (view Figure 1), Choi and Lee, alone or in combination fail to explicitly teach wherein: the needle body comprises a protrusion disposed at the other end of the needle body and insertable into the handpiece body, and the handpiece body comprises an insertion hole into which the protrusion to be inserted.
However, Suh (KR 101122526 B1) teaches a skin beauty treatment device with a needle assembly ([0001]) which “includes a needle fixing block (122) with a needle (121) fixed to its front end, a shaft coupling block (124) formed at the rear end of the needle fixing block (122) as a part coupled to the shaft (140), a connecting part (126) connecting the needle fixing block (122) and the shaft coupling block (124), and a protrusion (126) formed at the rear end of the shaft coupling block (124)...the needle assembly (120) be rotated as described below to insert both ends of the shaft coupling block (124) into the first and second coupling grooves (141a, 141b) of the shaft (140).” ([0032]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Choi and Lee to incorporate the teachings of Suh to have the needle body comprises a protrusion disposed at the other end of the needle body and insertable into the handpiece body, and the handpiece body comprises an insertion hole into which the protrusion to be inserted, as these prior art references are directed to skin treatment devices. One would be motivated to do this to be able to attach the needle body to the handpiece.
Alternatively, Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Lee as applied to claim 1 above, and further in view of Kang (US Patent 8,666,487 B2), hereinafter Kang.
Regarding claim 8, Choi (alternatively in view of Lee) discloses the electric device of claim 1 (as shown above). Choi and Lee, alone or in combination, fail to teach wherein the needles have different heights from each other.
However, Kang discloses a device for skin treatment which transmits energy to a skin tissue (Abstract) wherein the needles have different heights from each other (Figure 13-15, Column 8, lines 1-3: “As shown in FIGS. 13 to 15, the needles 100 held by the needle holding unit 200 may comprise two or more kinds having different lengths.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Choi and Lee to incorporate the teachings of Kang to have the needles have different heights from each other, as these prior art references are directed to skin treatment devices. One would be motivated to treat different thickness of skin.
Allowable Subject Matter
Claims 3 and 6 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, in view of prior art made of record.
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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