DETAILED ACTION
The amendment filed May 14, 2025, has been entered and fully considered. Claims 1-13 are pending. Claims 1 and 8 are amended.
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 (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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 14, 2025, has been entered.
Claims 1, 2, 6-8, 10, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbrook et al., (hereinafter 'Whitbrook,' U.S. PGPub. No. 2017/0319235) in view of Boll et al., (hereinafter 'Boll,' U.S. PGPub. No. 2018/0000533).
Regarding claim 1, Whitbrook disclose an apparatus for tissue treatment comprising: a directing mechanism (guide/handle 78) comprising a guide formed with a lumen that extends through a longitudinal axis of said guide (see lumen (not labeled) through guide/handle 78 that receives energy delivery elements 72 in Fig. 21; also se Figs. 23-24), said lumen being open at a distal end thereof (Figs. 21 and 22); a connecting element coupled to said guide (see adjustment element (not labeled) and indicated by arrows in Fig. 22); a urethral positioning fixator (urethral shaft 76, inflatable positioning balloon 74) coupled to said connecting element (via guide/handle 78), a longitudinal axis of said urethral positioning fixator being offset from the longitudinal axis of said lumen of said guide (see Fig. 21 for longitudinal axis of urethral shaft 76 being offset from the longitudinal axis of said lumen of said guide (not labeled)); an active electrode (72) comprising a distal conductive tip, said distal conductive tip being arranged to advance linearly on the longitudinal axis of said lumen (see double-sided arrow in Fig. 21 indicating said distal conductive tip being arranged to advance linearly on the longitudinal axis of said lumen) and protrude past said distal end of said lumen to a target tissue (Fig. 21), said distal conductive tip configured to continue linearly on the longitudinal axis of said lumen until reaching the target tissue (Fig. 21); a return electrode offset from said longitudinal axis of said lumen of said guide (see Figs. 23 and 24 for ‘return electrode’ 72 offset from other ‘active electrode’ 72; [0081]; [0089]) such that said urethral positioning fixator (76, 74) and said return electrode are located on opposite sides of said guide (see Figs. 21-24; as broadly claimed, Fig. 21 illustrates that electrodes 72 can extend proximally such that a portion of electrode 72 extends on an opposite side of said guide 78 than that of urethral shaft 76, inflatable positioning balloon 74).
Whitbrook is silent regarding a main unit comprising an RF generator, a controller unit, a power supply and a user interface, said main unit configured to deliver RF energy between said return electrode and said conductive tip of said active electrode to create collagen contraction of the target tissue in a vicinity of said active electrode.
However, in the same field of endeavor, Boll teaches a similar system for tissue treatment (abstract; exemplary system 100 in Figs. 1A-1B; exemplary system 1200 in Fig. 12) comprising a first probe (1230 in Fig. 12) including an active electrode (array 1260a of electrodes 1262a in Fig. 12) and a second probe (1230b in Fig. 12) including a return electrode (array 1260b in Fig. 12) which provides an electrical return path ((0192]). The system (100 in Figs. 1A-1B; 1200 in Fig. 12) further includes a main unit (console 110 in Figs. 1A-1B; console 1210 in Fig. 12) comprising an RF generator (RF energy generators 135, 136 in Fig. 1A; also see RF generator in Fig. IB: RF power source 1235 in Fig. 12; also see abstract “the systems can comprise one or more sources of RF energy (e.g., an RF generator)”), a controller unit ([0065], “controller 137 (e.g., including a CPU or microprocessor) for controlling the operation of the RF energy generators 135, 136” in Fig. 1A; microprocessor 1237 in Fig. 12), a power supply (power supply 139 in Fig. 1A; also see Fig. IB; [0065]) and a user interface ([0176], “Systems incorporating the devices are also encompassed by the present teachings including, for example, controllers, power supplies, coolant reservoirs, monitors and alarms, all or some of which can be incorporated into a console providing a graphic user interface and displaying various parameters”; switching controls 1211), said main unit (console 110 in Figs. 1A-1B; console 1210 in Fig. 12) configured to deliver RF energy between said return electrode and a conductive tip of said active electrode to create collagen contraction in a vicinity of said active electrode ((0192], array 1260a of electrodes 1262a and probe 1230b provides an electrical return path in Fig. 12; see abstract, “the deposition of RF energy can be selectively controlled to help ensure heating uniformity during one or more of body sculpting treatment (lipolysis), skin tightening treatment... vaginal laxity or rejuvenation treatment, urinary incontinence treatment...the systems can comprise one or more sources of RF energy (e.g., a RF generator), a treatment applicator comprising one or more electrode arrays configured to be disposed in contact with a tissue surface, and a return electrode). This configuration is utilized in order to provide selective and controllable deposition of RF energy (abstract), thereby ensuring heating uniformity during treatment and increasing versatility of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the apparatus as taught by Whitbrook to include a main unit comprising an RF generator, a controller unit, a power supply and a user interface, said main unit configured to deliver RF energy between said return electrode and a conductive tip of said active electrode to create collagen contraction of the target tissue in a vicinity of said active electrode as taught by Boll in order to provide selective and controllable deposition of RF energy (abstract), thereby ensuring heating uniformity during treatment and increasing versatility of treatment.
Regarding claim 2, Whitbrook and Boll teach all of the limitations of the apparatus according to claim 1. Whitbrook discloses wherein said connecting element has an adjustable length that changes an amount said longitudinal axis of said urethral positioning fixator is offset from said longitudinal axis of said lumen of said guide (see arrows for telescopic adjustment in Fig. 22; see [0090], “The guide/handle 78 of the treatment device 70 of FIG. 21 serves to precisely position the energy delivery elements relative to a stable anatomic structure, such as the bladder neck and urethra. Proper alignment of the energy delivery elements may need to be adjusted and set differently for different patients. Guide/handle 78 may include one or more adjustments, as shown in FIG. 22. Here, the vertical height may be adjusted by elongating the guide/handle 78. Although not shown, guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft. Also, the lateral spacing of the energy delivery elements may be facilitated by an adjusting mechanism.”).
Regarding claim 6, Whitbrook and Boll teach all of the limitations of the apparatus according to claim 1. Whitbrook (Figs. 21-22) discloses wherein said connecting element (Fig. 22) is perpendicular to said urethral positioning fixator (76, 74).
Regarding claim 7, Whitbrook and Boll teach all of the limitations of the apparatus according to claim 1. Whitbrook (Figs. 21-22) discloses wherein said connecting element (Fig. 22) is perpendicular to said guide (see lumen (not labeled) through guide/handle 78 that receives energy delivery elements 72 in Fig. 21; also se Figs. 23-24).
Regarding claim 8, Whitbrook discloses a method for tissue treatment comprising using the apparatus of claim 1 (see rejection of claim 1 above) and: inserting said urethral positioning fixator into a urethra of a patient (urethral shaft 76, inflatable positioning balloon 74 in Figs. 21-24); passing said active electrode (energy delivery elements 72 , ‘active electrodes’ energy contacts 16) through said distal end of said lumen so that said conductive tip of said active RF electrode first pierces an outer surface of the patient between the urethra and a vagina of the patient ([0088], “Energy delivery elements 72 are then advanced, placing them within the vaginal wall or into tissue outside of the vagina at a location of interest.”) and then said distal conductive tip continues linearly along the longitudinal axis of said lumen until reaching the target tissue between the urethra and the vagina (as broadly claimed, said distal conductive tip 72 continues in a linear direction along the longitudinal axis of said lumen until reaching the target tissue, as illustrated in Figures 21-24, between the urethra and the vagina); inserting a return electrode into the vagina (Figs. 23 and 24 illustrate inserting ‘return electrodes’ energy contacts 16; see [0081], “multiple monopolar needles may be paired in such a way that they deliver bipolar energy between them.”; see [0089]); and applying RF energy between said active electrode and said return electrode ([0081], “multiple monopolar needles may be paired in such a way that they deliver bipolar energy between them.” Also see [0089]).
Further, in view of the prior modification of Whitbrook in view of Boll, Boll teaches applying RF energy between said active electrode and said return electrode to create collagen contraction in a vicinity of said active electrode to contract collagenous tissue between the urethra and the vagina ([0192], array 1260a of electrodes 1262a and probe 1230b provides an electrical return path in Fig. 12; see abstract, “the deposition of RF energy can be selectively controlled to help ensure heating uniformity during one or more of body sculpting treatment (lipolysis), skin tightening treatment... vaginal laxity or rejuvenation treatment, urinary incontinence treatment...the systems can comprise one or more sources of RF energy (e.g., a RF generator), a treatment applicator comprising one or more electrode arrays configured to be disposed in contact with a tissue surface, and a return electrode).
Regarding claim 10, Whitbrook in view of Boll teach all of the limitations of the method according to claim 8. In view of the prior modification of Whitbrook in view of Boll, Boll teaches comprising using the RF energy to heat the tissue between the urethra and the vagina above 45°C (see [0079], temperatures may range from 39°C to about 47°C, [0079], “In some aspects, the temperature range from about 41°C to about 42° C can be used to preferentially stimulate collagen development. Higher temperatures up to about 46-47° C can be used to target tissues with more damage, thus providing a more aggressive treatment”).
Regarding claim 11, Whitbrook in view of Boll teach all of the limitations of the method according to claim 8. In view of the prior modification of Whitbrook in view of Boll, Boll teaches measuring temperature at said active electrode or said return electrode and using the temperature to control RF energy delivery to said active electrode ([0018], “temperature detectors for detecting a temperature of the tissue surface around the perimeter of the electrode array, wherein the controller is further configured to adjust the RF signals,” i.e. reduce or increase the power of the treatment RF signals; [0023], “At least one temperature sensor can also be incorporated into the probe to monitor the temperature of the vaginal wall surface and/or the target tissue”).
Regarding claim 13, Whitbrook and Boll teach all of the limitations of the method according to claim 8. Whitbrook discloses further comprising adjusting a length of said connecting element so as to change an amount said longitudinal axis of said urethral positioning fixator is offset from said longitudinal axis of said lumen of said guide (see arrows for telescopic adjustment in Fig. 22; see [0090], “The guide/handle 78 of the treatment device 70 of FIG. 21 serves to precisely position the energy delivery elements relative to a stable anatomic structure, such as the bladder neck and urethra. Proper alignment of the energy delivery elements may need to be adjusted and set differently for different patients. Guide/handle 78 may include one or more adjustments, as shown in FIG. 22. Here, the vertical height may be adjusted by elongating the guide/handle 78. Although not shown, guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft. Also, the lateral spacing of the energy delivery elements may be facilitated by an adjusting mechanism.”).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbrook in view of Boll as applied to claim 1 above, and further in view of Rosenblatt (hereinafter ‘Rosenblatt,’ U.S. Pat. 8,079,963).
Regarding claim 3, Whitbrook and Boll teach all of the limitations of the apparatus according to claim 1, but are silent regarding wherein said connecting element is pivotable and lockable at any desired orientation with respect to said urethral positioning fixator or said guide.
However, in the same field of endeavor, Rosenblatt teaches a similar apparatus for tissue treatment including a connector device (16 in Fig. 5) that is pivotable to provide various, different angles between the two devices (vaginal delineator 9, rectal delineator 15) and may further lock into place (col. 2, ll. 30-35; col. 5, ll. 6-15). This connecting element is utilized in order to aid in positioning of the apparatus at various angle and maintain the apparatus at a desired angle (col. 2, ll. 30-35; col. 4, ll. 13-15), thereby increasing versatility and accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the connection element as taught Whitbrook in view of Boll to incorporate the connection element as taught by Rosenblatt in order to aid in positioning of the apparatus at various angle and maintain the apparatus at a desired angle (col. 2, ll. 30-35; col. 4, ll. 13-15), thereby increasing versatility and accuracy. Further, this modification would have merely comprised a simple substitution of one well known connection element for another in order to produce a predictable result, MPEPE 2143(1)(B).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbrook in view of Boll as applied to claim 1 above, and further in view of Ingle et al., (hereinafter ‘Ingle’, U.S. Pat. 6,546,934).
Regarding claims 4 and 5, Whitbrook in view of Boll teach all of the limitations of the apparatus according to claim 1. Although Whitbrook teaches the “[g]uide/handle 78 may include one or more adjustments, as shown in FIG. 22. Here, the vertical height may be adjusted by elongating the guide/handle 78. Although not shown, guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft. Also, the lateral spacing of the energy delivery elements may be facilitated by an adjusting mechanism.”), Whitbrook in view of Boll are silent regarding wherein said urethral positioning fixator is parallel to said lumen of said guide and is parallel to said active electrode.
However, in the same field of endeavor, Ingle teaches a similar device (250 in Fig. 18A) comprising a transvaginal probe (252) and a transrectal probe (254) including electrodes (266, 268). Ingle teaches that the “[p]roximal ends 256 are mechanically coupled by a clamp structure 260. Rotating a handle 262 of clamp structure 260 changes a separation distance 264 between electrodes 266, 268 via threads 270. Hence, clamping structure 260 helps maintain the parallel alignment between the electrodes” (col. 30, ll. 18-23). This configuration “may help to stabilize the location and direction of the vaginal probe so that it can provide heating to the deep tissues above and to the sides of the vagina” (col. 31, ll. 46-48), thereby increasing stability, safety and efficiency. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Whitbrook in view of Boll to provide a configuration wherein said urethral positioning fixator is parallel to said lumen of said guide and is parallel to said active electrode as taught by Ingle in order to “help to stabilize the location and direction of the vaginal probe so that it can provide heating to the deep tissues above and to the sides of the vagina” (col. 31, ll. 46-48), thereby increasing stability, safety and efficiency.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbrook in view of Boll as applied to claim 8 above, and further in view of Deckman et al., (hereinafter ‘Deckman’, U.S. PGPub. No. 2013/0296690).
Regarding claim 9, Whitbrook in view of Boll teach all of the limitations of the method according to claim 8. Although Whitbrook discloses wherein said active RF electrode has a distal conductive tip and the RF energy is delivered to said conductive tip ([0081]; [0089]), Whitbrook in view of Boll are silent regarding an insulating shaft.
However, in the same field of endeavor, Deckman teaches an active RF electrode (conductive needle distal tip 54 in Figs. 8A-8C) having an insulating shaft (Figs. 8A-8C; [0071], “insulating material 140 extends longitudinally along at least an exterior portion 142 of the needle 14 terminating proximal to the conductive needle distal tip 54”). Deckman teaches “[t]he conductive needle distal tip 54 is extendable from a distal end 146 of the retractable sheath 144. The proximal retraction of the sheath 144 may be used to selectively control the length of the needle distal tip 54” ([0071]), thereby increasing control over the size of the active region and subsequent treatment. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the active RF electrode as taught by Whitbrook in view of Boll to include an insulating shaft as taught by Deckman in order to selectively control the length of the active distal tip ((0071]), thereby increasing control over the size of the active region and subsequent treatment.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbrook in view of Boll as applied to claim 8 above, and further in view of Zarins et al., (hereinafter ‘Zarins,’ U.S. PGPub. No. 2018/0110554).
Regarding claim 12, Whitbrook in view of Boll teach all of the limitations of the method according to claim 8, but are silent regarding wherein the return electrode has a substantially larger area than a conductive area of the active electrode.
However, in the same field of endeavor, Zarins teaches a similar energy delivery device (Fig. 22) comprising both an active electrode (4006) and a return electrode (4000) wherein the return electrode (4000) may have a substantially larger area than a conductive area of the active electrode (4006), resulting in substantial heating of the active electrode with minimal or no heating of the return electrode ([0139]), thereby improving heating and lesion formation at the active electrode. Zarins further teaches applying RF energy between the active electrode and return electrode in order to heat the tissue wherein the energy can be applied in a monopolar, bipolar or combined fashion, thereby increasing versatility of treatment. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Whitbrook in view of Boll to include a return electrode having a substantially larger area than a conductive area of the active electrode as taught by Zarins in order to substantially heat the active electrode with minimal or no heating of the return electrode ([0139]), thereby improving heating and lesion formation at the active electrode, and increasing versatility of treatment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13 have been considered but are moot because the amendment has necessitated a new ground of rejection.
Applicant’s arguments are acknowledged. Specifically, Argument’s statement: “The above rejection is respectfully traversed. It appears Examiner has acknowledged the difference between the claimed invention and Whitbrook (even when Whitbrook is combined with any of the other cited art), which was presented in the previous response, but merely objects to the lack of this difference being set forth in the claims. That difference is, in contrast to the prior art, in the instant invention, the active electrode pierces the proximal face of the tissue and pierces tissue in a direction on the longitudinal axis of the lumen of the guide. This feature has now been set forth in the claims.” Applicant’s arguments are not found persuasive and are moot in view of the rejection set forth above.
Whitbrook teaches a configuration in which multiple needles may be paired in such a way that they deliver bipolar energy between them ([0081]). These energy delivery elements 72 are offset from one another and urethral shaft 76, an inflatable positioning balloon 74. Further, the energy delivery elements 72 extend on both sides of the guide and lumen (see above for further clarification), such that “a return electrode offset from said longitudinal axis of said lumen of said guide such that said urethral positioning fixator and said return electrode are located on opposite sides of said guide.” The energy delivery elements 72 are arranged to advance linearly on the longitudinal axis of said lumen and protrude past said distal end of said lumen to a target tissue.
Therefore, it is the Examiner’s position Whitbrook in view of Boll teach each and every limitation of independent claim 1 (and dependent claim 8) as amended.
No further arguments have been set forth regarding the dependent claims.
Conclusion
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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794