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.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: “moving mechanism configured to move” in claims 1-8.
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 § 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) and in further view of Lee (US 2014/0288622).
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). 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 between each of the inner electrodes and the outer electrode which creates an equal thermal effect around each of the inner electrodes due to the equal spacing (see [0025]). 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 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 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. 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).
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 return electrode is coupled to a housing by flanges that extend at a slant from a distal surface of said return electrode, and wherein an elongate conductor extends proximally from said distal surface (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, Lee, and in further view of Lei (US 2016/0228178).
Regarding claims 10-13, Epstein in view of Jurna and Lee teaches the limitations of claim 8 for which claims 10-13 are dependent upon. However, Epstein in view of Jurna and Lee 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 and Lee 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]).
Response to Arguments
Applicant’s arguments with respect to the rejected claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the new grounds of rejection are based on a combination of the Epstein, Jurna, and Lee references which has not been challenged in the current arguments.
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 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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/SEAN W COLLINS/Primary Examiner, Art Unit 3794