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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. The examiner was unable to find the following elements depicted or noted in the figures. The figures contain no notations corresponding to the elements recited in the specification and claims:
In claim 1, the flat plate made of conductive material having defined thereon a plurality of zones in an array having X rows and X columns in a plan view of the flat plate, each zone having a monopolar and bipolar hybrid switch module; grooves in each of the plurality of zones having M fractional microneedles inserted therein.
In claim 5, a ground in one or more of the M fractional microneedles to enable the one or more fractional microneedle to operate as a return path.
Therefore, these elements must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3 and 5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, the examiner’s position is that, as of the filing date of the instant specification, Applicant has not conveyed with reasonable clarity to those skilled in the art that the inventor was in possession of the invention as now claimed. This “possession” is not shown with such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). See MPEP 2163.02. For instance, there is no pictorial depiction of any structure of the claimed stimulation structure, and the textual description does not convey possession of what is claimed (see, e.g., pars. 7 and 19 of the instant disclosure appear to be the only text drawn to this structure). These passages do not indicate what is meant by “partitioning” or “defining” zones on a conductive plate (e.g., is there some sort of geometric separation between the zones, insulation between the zones, mere arbitrary consideration of the local area of each electrode to be a zone, or some other structural implication?), the “grooves” in relationship to these zones (e.g., are these “grooves” parallel to the surface of flat plate, partial apertures through the plate, apertures that pass fully through the plate, or some other structural implication?), and the original disclosure further fails to convey with reasonable clarity “possession” of monopolar and bipolar hybrid switch modules. Paragraph 14 of the original disclosure notes that “FIGS. 2 and 3 are radio frequency (RF) (ultrasonic) switching circuit diagrams that constitute the monopolar and bipolar switch modules,” with figures 2 and 3 showing various circuit diagrams with certain circuit elements denoted with unknown alphanumeric symbols that are not described in the specification in any way. There is no discussion of what elements constitute a “monopolar and bipolar hybrid switch module,” how these are connected or interrelated with the flat plate and fractional microneedles, or the manner in which they operate. This discussion appears limited to “FIGS. 2 and 3 are radio frequency (RF) (ultrasonic) switching circuit diagrams that constitute the monopolar and bipolar switch modules.”
The remaining claims are rejected by virtue of their dependency.
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 1, 3 and 5 are 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.
In regards to claim 1, “defining, on the flat plate, a plurality of zones” is vague. It is unclear what the scope of “defining…a plurality of zones” entails. For instance, is this a mental step of considering different areas to be different “zones,” providing insulation so that the zones of the conductive plate can carry separate voltages, merely making a geometric demarcation between zones, or some other scope. The disclosure does not appear to clarify what constitutes different “zones.” Further, it is unclear what element or elements constitute a “fractional microneedle.” It is unclear whether this requires something more than a conductive needle electrode, if so, what that additional structure might be, or if not, what structure is implied by “fractional.” Additionally, it is unclear what structure is required by a “monopolar and bipolar switch module.” Paragraph 14 of the original disclosure notes that “FIGS. 2 and 3 are radio frequency (RF) (ultrasonic) switching circuit diagrams that constitute the “monopolar and bipolar switch modules,” with figures 2 and 3 showing various circuit diagrams with certain circuit elements denoted with unknown alphanumeric symbols that are not described in the specification in any way. It is unclear which element or elements of Figs. 2 and 3 constitute the “monopolar and bipolar switch modules” and how they are interrelated to the structural features of the microneedle array structure. Additionally, the scope of “grooves” is vague. Due to the lack of guidance by the original disclosure, it is unclear whether these are grooves parallel with the face of the flat plate, are partial apertures, apertures passing through the plate, or some other scope.
In regards to claim 3, the claim is a “manufacturing method” claim. Claim 1 requires each of the zones to have a ““monopolar and bipolar switch module,” which implies that this is an element that can be selectively set to either a monopolar or bipolar mode. However, claim 3 requires “selecting a monopolar type or a bipolar type of the monopolar and bipolar hybrid switch module,” implying that during manufacture, either a monopolar type or a bipolar type is used in the manufacturing process (and not a hybrid module that can be selectively set to either a monopolar or bipolar mode). Clarification is respectfully requested.
In regards to claim 5, the phrase “forming a ground in one or more of the M fractional microneedles” is vague because it is unclear whether “forming a ground” is a structural feature of one or more of the needles (e.g., an additional electrode on the needle that can serve as ground electrode), or whether this limitation is merely drawn to selecting one or more of the needles using the switch to serve as a ground/return electrode.
Allowable Subject Matter
Claims 1, 3 and 5 (as best understood) appear to avoid the prior art, but remain rejected under 35 U.S.C. 112(a)/(b) or 35 U.S.C. 112 (pre-AIA ), 1st/2nd paragraph, set forth in this Office action.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive. Applicant argued that the (1) claims are understandable without the drawings and comply with 37 CFR 1.83(a), and (2) that drawings are provided in the priority documents (PCT/KR2020/014465 and KR 10-2020-0135251) to provide adequate support for the claimed subject matter. In regards to the first argument, please see the drawings objections and rejections under section 112 above. The examiner respectfully maintains that, due to the structural and functional relationships required by the claims, the lack of guidance provided by the drawings do not show every feature of the claims and there is no evidence that these are conventional features disclosed in the description and the claims, rendering the drawings essential for proper understanding of the claims. See 37 CFR 1.83(a).
In regards to the second argument, no subject matter from the priority documents has been incorporated by reference into the instant application. The examiner is required to consider the application as filed to evaluate sufficiency of disclosure of the drawings and specification. Although the priority documents may or may not provide sufficient disclosure in the drawings and text to support the claimed subject matter, these documents have not been incorporated by reference, and as constituting “essential material,” the instant disclosure has not been amended to include the subject matter from these documents to provide written description support and sufficiency of the drawings. See MPEP 608.01(p). Accordingly, the examiner respectfully maintains the rejections for the reasons stated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792