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
Applicant’s election without traverse of Group I (Claims 1-13) in the reply filed on 7/24/2026 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a cooling unit” and “ a gas transferring unit” in claim 11 and “ a second storage unit in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2-8 are are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter. Applicant recites part of a human, i.e. “…wherein a contact surface at a portion of the tip that is brought into contact with the skin” Claim 2, lines 2-3). Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be brought into contact" when referring to the location of the tip in relation to the skin.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”).
Regarding claim 1, Park teaches a multipolar-type output apparatus (e.g. abstract, [0012],[0020],[0021], Figs.1A,1B,2,3,4A) comprising:
a body configured to generate a high frequency energy (i.e. high frequency output device main body, e,g. [0041]-[0043]);
a handpiece (e.g. 10 Fig.1, [0041]-[0043]) detachably attached to the body and configured to transmit the high frequency energy received from the body to the tip; and
a tip (i.e. base, e.g. 20 Fig.1, [0041]-[0043]) detachably attached to the handpiece and comprising an electrode unit ( e.g. 30,40 Fig.1) configured to transmit the high frequency energy received from the handpiece to skin, wherein the electrode unit comprises a first electrode ( e.g. 31a Fig.1,[0071]) and a second electrode ( e.g. 41a Fig. 1,[0072]), the first electrode and the second electrode having a size different from each other (31 and 41 are of different sizes Figs. 6-12).
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.
Claims 1 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (International Publication Number: WO 2022/204226 A1, hereinafter “Jang” (Note: U.S. 2024/0075279 A1 used for citing relevant paragraph numbers) in view of Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”).
Regarding claim 1, Jang teaches a multipolar-type output apparatus (e.g. abstract, 1000 Figs. 1, 11) comprising:
a body configured to generate a high frequency energy (i.e. skin management device e.g. 100 Fig.1, [0061]-[0066]);
a handpiece (i.e. handpiece e.g. 200 Fig.1, [0061]-[0066]) configured to transmit the high frequency energy received from the body to the tip; and
a tip (i.e. electrode unit e.g. 300 Fig.1, [0061]-[0066]) comprising an electrode unit configured to transmit the high frequency energy received from the handpiece to skin, wherein the electrode unit comprises a first electrode ( e.g. 310-1-310-N,[0066]) and a second electrode (e.g. 320-1-320-N,[0066]).
Jang does not specifically teach that the that the body, handpiece and tip are detachably attached to each other and that the first and second electrodes have different sizes. In a similar field of endeavor, Park teaches a multipolar-type output device wherein the body, handpiece and tip are detachably attached to each other and that the first and second electrodes have different sizes (e.g. abstract, [0012],[0020],[0021], Figs.1A,1B,2,3,4A, [0041]-[0043] and as discussed in the 102 rejection discussed above).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Jang with detachable components and differently sized electrodes as taught by Park in order to provide the predictable results of a controllable therapy and improved therapeutic effects as well as a modular device with easily replaceable parts.
Regarding claim 7, Jang in view of Park teaches the claimed invention as discussed above and Jang further teaches that the body comprises an energy generation unit configured to generate high frequency energy transmitted to the electrode unit and a body controller configured to control a polarity of the high frequency energy (e.g. [0063]).
Regarding claim 8, Jang in view of Park teaches the claimed invention as discussed above and Jang teaches that the body controller is operable to set the polarity of the high frequency energy in at least two different irradiation modes, in which the high frequency energy having different polarities depending on the at least two irradiation modes, according to a user input (e.g. [0068]-[0085]: monopolar and bipolar modes and setting of polarities in the two modes).
Regarding claims 9 and 10, Jang in view of Park teaches the claimed invention as discussed above and Jang teaches the first electrode comprises a first group of multiple first electrodes and a second group of multiple first electrodes and the second electrode comprise one or more second electrodes (e.g. 310-1-310-N and 320-1-320-N, [0066]),
wherein the body controller is operable to set the polarity of the high frequency energy in at least two different irradiation modes, wherein the at least two different irradiation modes comprise:
a first irradiation mode, in which the first group of multiple first electrodes have a positive (+) polarity while the second group of multiple first electrodes have a negative (-) polarity and wherein the one or more second electrodes are controlled not to irradiate with the high frequency energy and
a second irradiation mode, in which the first group of multiple first electrodes, the second group of multiple first electrodes, the one or more second electrodes have a same polarity, either positive (+) or negative (-) (e.g. [0068]-[0085]: monopolar and bipolar modes and setting of polarities in the two modes).
Claim 2, 3, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (International Publication Number: WO 2022/204226 A1, hereinafter “Jang” (Note: U.S. 2024/0075279 A1 used for citing relevant paragraph numbers) in view of Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”) and further in view of Schouenborg (U.S. Patent Application Publication Number: US 2006/0085056 A1, hereinafter “Schouenborg”).
Regarding claims 2, 3, 5 and 6, Jang in view of Park teaches the claimed invention as discussed above and while they teach that the tip comprises a contact surface at a portion of the tip that is brought into contact with the skin (e.g. [0021],[0078],[0079]) and that the electrode unit may be invasive microneedles OR a plurality of noninvasive electrodes (e.g. [0004], [0015], [0088]), they do not specifically teach that the first electrode is in a protruding shape protruding from the contact surface of the tip, while the second electrode is in a flat shape and wherein the wherein the first electrode is in form of a needle to invade into the skin (as claimed in claim 3) and wherein the first electrode comprises a plurality of first electrodes, each of which being in the protruding shape, the second electrode, which is in the flat shape, is provided in an area surrounding the plurality of first electrodes, while the plurality of first electrodes and the second electrode are distanced away from each other on the contact surface of the tip such that the plurality of first electrodes and the second electrode are not electrically connected on the contact surface of the tip ( as claimed in claim 5) and that one of the one or more second electrodes is provided in an area surrounding the first group of multiple first electrodes, and the other of the one or more second electrodes is provided in an area surrounding the second group of multiple first electrodes (as claimed in claim 6)
Schouenborg teaches an electrode plate for use for cosmetic purposes (e.g. Abstract, [0002]) comprising needle-like (NL) electrode and conductive plate (CP) electrodes (e.g. [0053], Fig.1) interspersed with each other such that while the plurality of first electrodes and the second electrode are distanced away from each other on the contact surface of the tip such that the plurality of first electrodes and the second electrode are not electrically connected on the contact surface of the tip ( as claimed in claim 5) and that one of the one or more second electrodes is provided in an area surrounding the first group of multiple first electrodes, and the other of the one or more second electrodes is provided in an area surrounding the second group of multiple first electrodes (as claimed in claim 6).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Jang in view of Park to have needle like electrodes as well as conductive plate electrodes as first and second electrode interspersed with each other as taught by Schouenborg in order to provide the predictable results of improving therapeutic effects and providing a more controlled stimulation.
Claim 4 rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (International Publication Number: WO 2022/204226 A1, hereinafter “Jang” (Note: U.S. 2024/0075279 A1 used for citing relevant paragraph numbers) in view of Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”) and Schouenborg (U.S. Patent Application Publication Number: US 2006/0085056 A1, hereinafter “Schouenborg”) and further in view of Ko (U.S. Patent Application Publication Number: US 2014/0358200 A1, hereinafter “Ko”).
Regarding claim 4, Jang in view of Park teaches the claimed invention as discussed above except for the first electrode being in form of a mild protrusion not to invade into the skin.
In a similar field of endeavor, Ko teaches protruding electrodes that have ends that are formed in a spherical shape or a flat shape that form contact side with the skin surface (e.g. [0052]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Jang in view of Park with a flat or spherical shaped end of the protruding electrodes in order to provide the predictable results of improving safety while ensuring proper contact with the skin.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (International Publication Number: WO 2022/204226 A1, hereinafter “Jang” (Note: US 2024/0075279 A1 used for citing relevant paragraph numbers) in view of Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”) and further in view of Nebrigic (U.S. Patent Application Publication Number: US 2011/0202048 A1, hereinafter “Nebrigic”).
Regarding claim 11, Jang in view of Park teaches the claimed invention as discussed above except for the body comprising a cooling unit, wherein the handpiece comprises a gas transferring unit configured to receive a cooling gas generated from the cooling unit of the body and to transfer the cooling gas to the tip, and wherein the tip comprises a chamber where the cooling gas supplied from the gas transferring unit stays when the cooling gas is output.
In a similar field of endeavor, Nebrigic teaches a high frequency energy delivery skin treatment device (e.g. Abstract , [0029]) and further teaches a cooling unit( e. 15 Fig 1) , wherein the handpiece comprises a gas transferring unit configured to receive a cooling gas generated from the cooling unit of the body and to transfer the cooling gas to the tip, and wherein the tip comprises a chamber where the cooling gas supplied from the gas transferring unit stays when the cooling gas is output ( e.g. [0030], Figs.2,3, [0043]-[0047]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the body in the teachings of Jang in view of Park with a cooling unit and the controller to control the cooling unit as wells as the handpiece comprising a gas transferring unit configured to receive a cooling gas generated from the cooling unit of the body and to transfer the cooling gas to the tip, and wherein the tip comprises a chamber where the cooling gas supplied from the gas transferring unit stays when the cooling gas is output as taught by Nebrigic in order to provide the predictable results of improving safety and reducing pain during treatment
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (International Publication Number: WO 2022/204226 A1, hereinafter “Jang” (Note: US 2024/0075279 A1 used for citing relevant paragraph numbers) in view of Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”) and further in view of Nebrigic (U.S. Patent Application Publication Number: US 2011/0202048 A1, hereinafter “Nebrigic”) and further in view of Koifman et al (U.S. Patent Application Publication Number: US 2020/0001108 A1, hereinafter “Koifman”).
Regarding claim 12, Jang in view of Park and Nebrigic teaches the claimed invention as discussed above and while Jang teaches that the body comprises a body controller as discussed above, they do not teach a storage storing a first identification value; wherein the tip comprises a second storage unit storing a second identification value of the tip, wherein the body controller configures to determine matching of the first identification value and the second identification.
In a similar field of endeavor, Koifman teaches a skin treatment device comprising disposable tips that comprises identification values which are recognized by the controller when a tip is connected (e.g. [0024],[0025]) and therefore they teach the controller comprises a storage storing a first identification value and a tip that comprises a second storage unit storing a second identification value of the tip, wherein the body controller is configured to determine matching of the first identification value and the second identification as claimed.
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the controller of Jang in view of Park and Nebrigic to have a storage storing a first identification value and the tip of Jang in view of Park and Nebrigic to comprise a second storage unit storing a second identification value of the tip and configuring the controller to determine matching of the first identification value and the second identification as taught by Koifman in order to provide the predictable results of ensuring that the proper tips are being used for treatment.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jang et al (International Publication Number: WO 2022/204226 A1, hereinafter “Jang” (Note: US 2024/0075279 A1 used for citing relevant paragraph numbers) in view of Park (U.S. Patent Application Publication Number: US 2025/0387635 A1, hereinafter “Park”) and further in view of Nebrigic (U.S. Patent Application Publication Number: US 2011/0202048 A1, hereinafter “Nebrigic”) and Koifman et al (U.S. Patent Application Publication Number: US 2020/0001108 A1, hereinafter “Koifman”) and further in view of Behrakis (U.S. Patent Application Publication Number: US 2009/0234343 A1, hereinafter “Behrakis”).
Regarding claim 13, Jang in view of Park and Nebrigic and Koifman teaches the claimed invention as discussed above and further Jang teaches a user interface that allows a user to selected between various modes (e.g. [0019], [0059] i.e. bipolar, monopolar, etc, Figs. 7 and 8), they do not specifically teach that at least two different operation selections that comprise a first operation selection in which the electrode unit performs one time irradiation operation and a second operation selection in which the electrode unit performs continuous irradiation.
In a similar field of endeavor, Behrakis teaches a skin treatment device that allows a user to select between a pulse mode for spot treat and a continuous mode for treatment of multiple locations (e.g. [0016]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the user interface in the teachings of Jang in view of Park and Nebrigic and Koifman to also allow for a selection of a single pulse mode or a continuous mode as taught by Behrakis in order to provide the predictable results of providing a more user friendly controllable options for selecting spot treatment or larger area treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
OH et al (U.S. Patent Application Publication Number: US 2021/0146686 A1, hereinafter “OH”) teaches a detachable electrode tip comprising a first and second electrode having different sizes.
Heine et al (U.S. Patent Application Publication Number: US 2010/0137752 A1, hereinafter “Heine”) teaches a skin treatment apparatus that applies current in a monopolar or a bipolar current node (e.g. [0062]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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