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 .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 May 2026 has been entered.
Claim Interpretation
The examiner adopts the position argued by applicant on pg. 7-8 of the remarks filed 12 May 2026 that “moving mechanism configured to move” in the claims would be understood by one of ordinary skill in the art to recite sufficient structure for accomplishing the claimed functionality. Specifically, the examiner interprets “a moving mechanism” to encompass a class of mechanisms used for providing controlled movement of conductive elements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Epstein (US 2017/0112568) in view of Jurna et al. (US 2017/0189668).
Regarding claim 1, Epstein teaches a device for tissue coagulation (see Figs. 3-5) comprising: a plurality of conductive elements (see microneedles 305/505, Figs. 4a-5; Fig. 5 is the detailed view of tip section 304, [0033]); and a moving mechanism configured to move said plurality of conductive elements relative to the tip of the device (see [0035]), and wherein in an inactive mode of the device said plurality of conductive elements do not protrude distally beyond the a distal face of the device (see tips of microneedles in Fig. 4c), and in an active mode of the device, said tips of said plurality of conductive elements protrude distally from a distal face of a housing (see tips of microneedles 305/505, Figs. 4a, 4b, and 5), said distal face being a skin-contact surface for contacting skin that lies over said treated tissue (the distal face of 513 of where needles 505 protrude from is considered capable of being in contact with skin over tissue to be treated as claimed by virtue of its planar construction), wherein said plurality of the conductive elements is operatively coupled to a radio-frequency generator (see signal generator 106, [0021]), wherein said plurality of the conductive elements is divided into groups (see groups of microneedles as shown in Figs. 4a-5). However, Epstein fails to teach a return electrode comprising an array of apertures, each of said apertures being aligned with a tip of one of said conductive elements, wherein each of said plurality of the conductive elements is surrounded by said return electrode and a total area of said return electrode is larger than a total area of said plurality of the conductive elements; and wherein the moving mechanism is configured to move said plurality of the conductive elements relative to the return electrode, and wherein in the inactive mode of the device said plurality of the conductive elements do not protrude distally beyond said return electrode, and in the active mode said tips of each of the said plurality of conductive elements protrudes through said aperture with which it is aligned, wherein said return electrode is located at least partially on said skin-contact surface and is located proximal to said tips; each of said groups having approximately an equal distance from said return electrode; and wherein said RF generator has an operating mode in which RF energy is applied between each of said groups of said conductive elements and said return electrode to create an approximately equal thermal effect around each of said conductive elements; and wherein said return electrode is coupled to said housing by flanges that extend at a slant from said distal surface of said return electrode, and wherein an elongate conductor extends proximal from said distal surface.
Jurna teaches a device for fractional tissue treatment (see Figs. 1A-1B) wherein the device comprises an RF generator (21) configured to supply an RF treatment voltage between an active inner electrode (1) that is surrounded by an outer return electrode (2) during an operation mode. Jurna further provides for additional embodiments with a plurality of conductive elements wherein each inner electrode is identically surrounded by a return electrode (see Figs. 3A-3E), the return electrode comprising an array of apertures that are aligned with each respective active inner electrode (see array of openings formed by the return electrode that each of the active electrodes are disposed within as shown in Fig. 3A-3E). Jurna additionally teaches wherein a ratio between a skin contact surface of the outer electrode and the skin contact surface of the inner electrode is greater than 2 and preferably greater than 10 (see [0013] and [0035]) and further teaches wherein the return electrode comprises a grid of electrode strips with identical spaces between said electrode strips (see grid patterns formed from linear strips of return electrode as shown in Figs. 3D and 3E, see also [0030]), wherein RF energy is applied during the operation mode of the RF generator between each of the inner electrodes and the outer electrode such that the operation mode creates an equal thermal effect around each of the inner electrodes due to the equal spacing (see [0025]). The grid of electrode strips as shown in Figs. 3A-3E provide borders that divide the electrodes into groups having approximately equal distance between the electrodes and surrounding return electrode (see annotated Figures below for examples). Jurna further teaches wherein an elongate conductor extends proximal from said distal surface (see wiring 22 extending proximally from the distal surface; [0025], Fig. 1A). Therefore, it would have been obvious to one of ordinary skill in the art before the time of filing to have modified the microneedle arrangement as taught by Epstein to be active microneedles surrounded a return electrode comprising an array of apertures, each of said apertures being aligned with a tip of one of said conductive elements, the return electrode with a larger total area than the microneedles, wherein distal surface of said return electrode lies on the skin-contacting surface and proximal to the tips of the plurality of microneedles in the active mode, each of said groups divided such that they each have an approximately equal distance from said return electrode; and wherein said RF generator has an operating mode in which RF energy is applied between each of said groups of said conductive elements via an elongate conductor extending proximal from said distal surface such that said return electrode creates an approximately equal thermal effect around each of said conductive elements as claimed in light of Jurna, the motivation being to provide a bipolar device that avoids heating of undesired portions of the skin present beneath the return electrode in a manner that requires less wiring from the RF generator to the outer electrodes, and allowing more electrodes to be arranged on the same surface as compared to separate outer electrodes (see Jurna [0013] and [0029]). As a result of the above combination, the device as taught by Epstein in view of Jurna is regarded as capable of moving the plurality of conductive elements relative to the return electrode as claimed since the return electrode would be located on the face of the tip section 513 as shown in Fig. 5 of Epstein when following the configuration shown by Jurna in Figs. 1B and 3A-3E, the tip of each of the conductive elements would protrude distally through said spaces/apertures of the return electrode in the active mode, since the active electrodes would be distally movable needles in this instance.
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Annotated Figures 3A-3E of Jurna
Regarding claim 2, Epstein further teaches wherein the plurality of conductive elements are needles (see microneedles 505, Figs. 5).
Regarding claim 3, Epstein further teaches wherein said RF energy has a frequency in a range of 100 kHz to 40 MHz (see “4 MHz”, [0024]).
Regarding claim 4, Epstein further teaches wherein said RF energy is delivered in a pulsed manner (see [0026]-[0027]).
Regarding claim 5, Epstein further teaches wherein part of a surface of each of the needles is coated by an electrically non-conductive material (see [0036]).
Regarding claim 6, Epstein further teaches where an amount of RF energy delivered to tissue is high enough to cause ablation of the tissue (see exemplary therapeutic temperature range of 55-68 degree Celsius, [0040]).
Regarding claim 7, Epstein further teaches where said plurality of conductive elements are movable into tissue to a depth of 0.1 mm to 10 mm (see “effective puncture length from about 0.5 mm - 4 mm in 0.5 mm increments”, [0034]).
Regarding claim 8, Epstein in view of Jurna further teaches a method for tissue coagulation (see use of the device as defined above in the rejection of claim 1) comprising: applying an RF device to a tissue to be treated (see rejection of claim 1 above), deploying a plurality of needles comprising conductive elements into the tissue, so that the conductive elements protrude distally through spaces in a distal portion of the RF device into a tissue at a first depth (see Epstein: extension of microneedles, thereby setting a skin puncture depth; [0032]-[0033], Figs. 4a-4c in light of the combination); applying a first radiofrequency (RF) voltage between the conductive elements (see Epstein: [0026] and [0031]), which are at said first depth, and a return electrode (see Epstein [0026] and [0031] in light of the above combination); retracting said plurality of the conductive elements from said first depth (as shown in Epstein: Figs. 4a-4c, see also [0031]-[0032]); and wherein said return electrode comprises an array of apertures, each of said apertures being aligned with the tip of one of said conductive elements, and wherein said conductive elements are divided into groups, each of said groups having approximately an equal distance from said return electrode; and wherein RF energy is applied between each of said groups of said conductive elements and said return electrode to create an approximately equal thermal effect around each of said conductive elements. (see rejection of claim 1 above). Epstein in view of Jurna and Lee fails to explicitly teach moving said conductive elements so that the tip of each of said conductive elements protrudes distally through said spaces in said distal portion of the RF device into the tissue at a second depth different from said first depth; and applying a second RF voltage between the tips of each of said conductive elements, which are at said second depth, and said return electrode. However, Epstein further teaches adjusting the length or degree to which the microneedles in the array reciprocate as desired (see Epstein: [0031]-[0034]). Therefore, it would have been further obvious to one of ordinary skill in the art before the time of filing to have adjusted the reciprocation depth and RF voltage application to a second depth to treat tissue as claimed in light of Epstein, the motivation being to provide for treatment of tissue at multiple treatment depths and treatment settings as desired (see Epstein: [0032] and [0033]-[0034]).
Regarding claim 9, Epstein in view of Jurna further teaches wherein higher RF energy is applied at a depth having a larger distance from said return electrode (higher amounts of RF energy are applied at the depth that the uninsulated distal portions of the needles; see Epstein: [0036]-[0037]).
Regarding claim 14, Epstein in view of Jurna further teaches wherein more than two depths are treated during one insertion cycle (this inherently occurs as RF energy radiates outward from the conductive tips and extends proximally through multiple depths to the return electrode).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Epstein in view of Jurna and in further view of Lei (US 2016/0228178).
Regarding claims 10-13, Epstein in view of Jurna teaches the limitations of claim 8 for which claims 10-13 are dependent upon. However, Epstein in view of Jurna fails to teach wherein RF energy is applied to a portion of a sweat gland so as to damage said portion of said sweat gland irreversibly so as to coagulate said portion of said sweat gland to reduce sweating and odor, and wherein RF energy is applied to a portion of a sweat gland so as to create coagulation zones at multiple depths.
Lei teaches a sweat gland treatment method using conductive needles (see Figs. 5 and 14) wherein RF energy is applied to a portion of a sweat gland so as to damage said portion of said sweat gland irreversibly so as to coagulate said portion of said sweat gland to reduce sweating and odor (see [0037]-[0038]), and wherein RF energy is applied to a portion of a sweat gland so as to create coagulation zones at multiple depths (see zones at multiple depths around the needles that necessarily be created as the treatment zone is created, see also needles that extend to different depths in Fig. 14 and [0043]). Therefore, it would have been obvious to one of ordinary skill in the art before the time of filing to have modified the application of RF energy as taught by Epstein in view of Jurna to further include wherein RF energy is applied to a portion of a sweat gland so as to damage said portion of said sweat gland irreversibly so as to coagulate said portion of said sweat gland to reduce sweating and odor, and wherein RF energy is applied to a portion of a sweat gland so as to create coagulation zones at multiple depths in light of Lei, the motivation being to properly cure hyperhidrosis in a patient (see Lei: [0038]).
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Epstein in view of Jurna and in further view of Lee (US 2014/0288622).
Regarding claims 15 and 18, Epstein in view of Jurna teaches the limitations of claims 1 and 8, respectively, in addition to teaching wherein an elongate conductor extends proximal from said distal surface as set forth in the rejection of claim 1. However, Epstein in view Jurna fails to teach wherein said return electrode is coupled to said housing by flanges that extend at a slant from said distal surface of said return electrode.
Lee teaches a tip structure for skin care (see Figs. 2-4) including a first electrode (see electrode 210, Fig. 2) as well as a second electrode (see electrode 110, Fig. 2), wherein the second electrode is coupled to the housing by flanges extending proximally from the distal surface (as shown in Fig. 2, see also [0021]-[0023]). 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 the return electrode as taught by Epstein in view of Jurna to further be coupled to the housing by flanges that extend from the distal surface of said return electrode in light of Lee, the motivation being to provide the additional benefit of provide a wide and stable contact area for the return electrode to further avoid concentration of currents (see Lee [0011] and [0023]). Epstein in view of Jurna and Lee fails to specifically teach the flanges extending at a slant from the distal surface, however it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the sides of the tip slanted in order to predictably create further widening of the return electrode and introduce additional stability. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. See MPEP 2144(IV)(B).
Claims 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Epstein in view of Jurna and in further view of Vaynberg et al. (US 2016/0114181).
Regarding claims 16-17 and 19-20, Epstein in view of Jurna teaches the limitations of claims 1 and 8, respectively. However, Epstein in view of Jurna fails to further teach wherein said RF generator is configured to deliver said RF energy to each group of said groups of said conductive elements according to a desired pattern, and sequentially deliver said RF energy to each group of said groups of said conductive elements.
Vaynberg teaches a fractional conductive needle device (see Figs. 1-10), wherein the needles are divided into chosen groups and pulses are sequentially delivered to each group of conductive needles according to a desired pattern of treatment (see [0163], [0232], and [0261]). Therefore, it would have been have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the energy delivery as taught by Epstein in view of Jurna such that wherein said RF generator is configured to deliver said RF energy to each group of said groups of said conductive elements according to a desired pattern, and sequentially deliver said RF energy to each group of said groups of said conductive elements in light of Vaynberg, the motivation being to provide the additional advantage of concentrating treatment only certain sections of contacted tissue while avoiding overheating tissue and minimizing pain (see Vaynberg: [0163], [0232], and [0239]).
Response to Arguments
Applicant's arguments filed 12 May 2026 have been fully considered but they are not persuasive.
To the extent that applicant argues that Epstein and Jurna fail to teach or suggest "wherein said plurality of the conductive elements is divided into groups, each of said groups having approximately an equal distance from said return electrode; and wherein said RF generator has an operating mode in which RF energy is applied between each of said groups of said conductive elements and said return electrode to create an approximately equal thermal effect around each of said conductive elements", as recited in amended independent claim 1, the examiner respectfully disagrees. The examiner contends that the combination of references teaches the argued limitation since Epstein as modified with Jurna above results in groups of needles divided via the return electrode disposed around them, or divided however one would desire to divide the plurality of electrodes as suggested by the combination since the claim does not require any specific manner of division for the groups. The groups as pointed out in Jurna are also all considered as creating “an approximately equal thermal effect around each of said conductive elements" during operation of the RF generator due to their approximately equal distance from the return electrode surrounding each of the elements of the groups.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached on M-F 9:00 AM-5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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