DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 26, 2026 has been entered.
Currently, claims 18-22, 24-34 and 36-40 are pending with claims 1-17, 23 and 35 cancelled, and claims 18-21 and 31-34 amended. The following is a complete response to the June 26, 2026 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 18-22, 24, 27 and 29 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (US Pat. No. 6,216,704 B1) further in view of Gafni et al. (US Pat. No. 6,741,895 B1).
Regarding claim 18, Ingle provides for a method for remodeling female genital tissue using an apparatus (see figure 5 with the apparatus at 40) comprising a treatment tip, wherein the treatment tip comprises an elongate shaft (shaft at 42), an energy delivery element (12), and a thermistor (see col. 12; 37-47; see also, col. 18; 22-30), wherein the energy delivery element is side-mounted with respect to a longitudinal axis of the elongate shaft and proximal to a distal end of the elongate shaft (see figure 5 with 12 being only a side of the elongate shaft 42 and proximal to the distal end at 48), and wherein the thermistor is located in close proximity to the energy delivery element (col. 18; 22-30 providing that the temperature sensors is “mounted adjacent the surface for engaging the tissue surface and measuring the temperature of the engaged tissue” which would place such near the element 12).
the method comprising inserting the distal end of the elongate shaft into an opening of a vagina of the female genital tissue (see figure 6 with the placement of the 42 within the vagina at V),
delivering, by the energy delivery element, an energy pulse to treat a therapeutic zone within a target tissue of the female genital tissue, wherein the target tissue comprises tissue between a mucosal epithelium and an endopelvic fascia of the female genital tissue (with respect to the arrangement displayed in figure 6, the application of energy via the electrodes of the element 12 to the vaginal wall which includes the mucosal epithelium wherein the energy passes through the tissue between the mucosal epithelium and the endopelvic fascia), and
measuring, by the thermistor, a temperature of the target tissue (see col. 12; 37-47 and col. 18; 22-30 providing for the measurement of temperature).
While Ingle contemplates for a plurality of arrangements of its RF electrode including for such to be a flat plate shape or to be a curved conductive surface that only covers a portion of a radial surface of an inflatable balloon (See at least col. 7; 1-15), Ingle fails to specifically provide with respect to the embodiment in figures 5/6 that the RF electrode is shaped so as to have a radial curvature with respect to the longitudinal axis of the elongate shaft while extending in parallel with the longitudinal axis of the shaft up to 30 degrees.
Gafni provides for a similar probe as that of Ingle for the application of energy to tissue wall of female genital tissue. Gafni further provides for each of its electrodes 26/28 to be curvilinear such that it curves radially with respect to the longitudinal axis of the elongate shaft while extending in parallel with the longitudinal axis (as in figure 2, and further in view of the disclosure in col. 9; 26-27 that describes that the electrodes sit flush to the surface of the cylindrical shaft 22) and for each electrode to only cover a portion of a radial surface of the shaft (again, as shown in figures 2, 8 and with9 the electrodes 26/28/211 to only cover a portion of 22/210).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the invention was made to have utilized a curvilinear shape that only covers a portion of the radial curvature of the shaft for each of electrodes 12a-d of Ingle in the embodiment shown in figures 5-6 in view of the teaching of Gafni. Again, Ingle readily contemplates a variety of shape and arrangements for its electrodes with Gafni readily exhibiting that curvilinear electrodes shapes are known in the art to provide the delivery of energy to the vaginal wall with a reasonable expectation of success.
While the above combination of Ingle and Gafni provide for the electrode to be curvilinear so as to only cover a portion of the radial curvature of the shaft, the combination, and in particular the disclosure of Gafni, fails to specifically provide that the radial curvature of the RF electrode with respect to the longitudinal axis of the elongate shaft is up to 30 degrees. The Examiner is, however, of the position that it would have been an obvious consideration to one of ordinary skill in the art that the time the invention was made to have utilized a radial curvature up to 30 degrees as claimed. Specifically, the RF electrode of the combination inherently possesses an amount of radial curvature greater than zero (0) degrees based on its extent around the cylindrical shape of the distal end of the device. Thus, the Examiner is of the position that the selection of a value between greater than 0 and up to 30 degrees for the radial curvature would represent values that would be appreciated by one of ordinary skill in the art as options for the extent to which the RF electrodes spans the outer surface of the shaft. The Examiner further notes that changes of size/proportion are known to be obvious in the art. See MPEP 2144.04(I)(V)(A) setting for that a mere change in the size of a component is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 19, Ingle provides that delivering the energy pulse to treat the therapeutic zone comprises delivering, by the RF electrode, RF energy to the therapeutic zone (see col. 18; 8-21 providing for the coupling to the RF power supply for the supply of RF energy to tissue).
Regarding claim 20, in view of the combination in the rejection of claim 18 above, the combined electrode would be curvilinear such that it curves radially with respect to the longitudinal axis of the elongate shaft while extending parallel with the longitudinal axis (via the curved shaped per the combination with Gafni and with the electrode having an extent along the shaft of the device of Ingle).
Regarding claim 21, Ingle provides that RF electrode is a monopolar electrode (as in figure 11 with the electrode functioning in a monopolar manner to return the energy to the electrode pad 82).
Regarding claim 22, Ingle provides that the RF electrode is one electrode of a bipolar electrode pair of the energy delivery element (via the arrangement in figures 5-6 with the bipolar functioning of 12 with the other electrodes 14).
Regarding claim 24, Ingle provides for the step of contacting the mucosal epithelium of the female genital tissue with the energy delivery element (via the contacting of such tissue when the element 12 is brought into contact with the vaginal wall as shown in figure 6).
Regarding claim 27, Ingle provides that the apparatus further comprises a cooling system within the elongate shaft (see figure 1 with the cooling system at 16, see also figures 5/6 with the cooling system connecting via 52 and extending through the shaft to the distal end of the element 12), the method further comprising cooling, by the cooling system, the energy delivery element (see at least col. 12; 13-27 to provide for cooling of 12).
Regarding claim 29, Ingle provides that the apparatus further comprises a programmable memory chip (see col. 12; 37-41 providing for the controller 22 being programmed with a computer program).
Claims 25, 26, 31-33 and 36-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) as applied to claim 18 above, and further in view of Garito et al. (US Pat. No. 6,458,124 B1).
Regarding claims 25 and 26, Ingle provides that the apparatus further comprises a hand piece (46 as in figure 5). Ingle fails to provide that the method further comprises releasably coupling the treatment tip to the hand piece (per claim 25), that the treatment tip further comprises a connector portion (per claim 26), and that releasably coupling the treatment tip to the hand piece comprises coupling the connector portion to the hand piece (per claim 26). Gafni fails to cure this deficiency in Ingle.
Garito discloses a similar device as that of Ingle and Gafni and specifically provides for the use of handpiece (12 in figures 5-7) and a treatment tip including an elongate shaft (electrode 13). Garito further provides for the treatment device to include a connector portion (portion at 24/26) for coupling the treatment tip to the handpiece (via such being coupled to the gripper 44). Garito then provide that such structure provides for the method steps of releasably coupling the treatment tip to the handpiece via the coupling of the connector portion to the handpiece (see at least col. 4; 4-29 providing for the manner in which the treatment tip and connector portion are coupled to the handpiece 12). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized a releasable coupling via a connector portion as in Garito to provide a removable treatment tip that would allow the user to selectively provide a desired treatment tip on the handpiece, and/or to replace a treatment tip in the instance of damage or overuse, and/or to render the handpiece to be reusable.
Regarding claim 31, Ingle provides for a method for remodeling female genital tissue using an apparatus (see figure 5 with the apparatus at 40) comprising a treatment tip (tip including the shaft 42 and the treatment element at 12) and a hand piece (46), wherein the treatment tip comprises an elongate shaft (42), an energy delivery element at a distal end of the elongate shaft (12), and a thermistor located in close proximity to the energy delivery element (col. 18; 22-30 providing that the temperature sensors is “mounted adjacent the surface for engaging the tissue surface and measuring the temperature of the engaged tissue” which would place such near the element 12), and wherein the energy delivery element is side-mounted with respect to a longitudinal axis of the elongate shaft (see figure 5 with 12 being only a side of the elongate shaft 42 and proximal to the distal end at 48),
inserting the distal end of the elongate shaft into an opening of a vagina of the female genital tissue (see figure 6 with the placement of the 42 within the vagina at V),
delivering, by the energy delivery element, an energy pulse to treat a therapeutic zone within a target tissue of the female genital tissue, wherein the target tissue comprises tissue between a mucosal epithelium and an endopelvic fascia of the female genital tissue (with respect to the arrangement displayed in figure 6, the application of energy via the electrodes of the element 12 to the vaginal wall which includes the mucosal epithelium wherein the energy passes through the tissue between the mucosal epithelium and the endopelvic fascia), and
measuring, by the thermistor, a temperature of the target tissue (see col. 12; 37-47 and col. 18; 22-30 providing for the measurement of temperature).
While Ingle provides that the apparatus further comprises the hand piece, Ingle fails to provide for a connector portion at proximal end of the elongate shaft, and that the method comprises releasably coupling the connector portion of the treatment tip to the hand piece.
Garito discloses a similar device as that of Ingle and specifically provides for the use of handpiece (12 in figures 5-7) and a treatment tip including an elongate shaft (electrode 13). Garito further provides for the treatment device to include a connector portion (portion at 24/26) for coupling the treatment tip to the handpiece (via such being coupled to the gripper 44). Garito then provide that such structure provides for the method steps of releasably coupling the treatment tip to the handpiece via the coupling of the connector portion to the handpiece (see at least col. 4; 4-29 providing for the manner in which the treatment tip and connector portion are coupled to the handpiece 12). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized a releasable coupling via a connector portion as in Garito to provide a removable treatment tip that would allow the user to selectively provide a desired treatment tip on the handpiece, and/or to replace a treatment tip in the instance of damage or overuse, and/or to render the handpiece to be reusable.
While Ingle contemplates for a plurality of arrangements of its RF electrode including for such to be a flat plate shape or to be a curved conductive surface that only covers a portion of a radial surface of an inflatable balloon (See at least col. 7; 1-15), Ingle fails to specifically provide with respect to the embodiment in figures 5/6 that the RF electrode is shaped so as to have a radial curvature with respect to the longitudinal axis of the elongate shaft while extending in parallel with the longitudinal axis of the shaft up to 30 degrees. Garito fails to cure this deficiency in Ingle.
Gafni provides for a similar probe as that of Ingle for the application of energy to tissue wall of female genital tissue. Gafni further provides for each of its electrodes 26/28 to be curvilinear such that it curves radially with respect to the longitudinal axis of the elongate shaft while extending in parallel with the longitudinal axis (as in figure 2, and further in view of the disclosure in col. 9; 26-27 that describes that the electrodes sit flush to the surface of the cylindrical shaft 22) and for each electrode to only cover a portion of a radial surface of the shaft (again, as shown in figures 2, 8 and with9 the electrodes 26/28/211 to only cover a portion of 22/210).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the invention was made to have utilized a curvilinear shape that only covers a portion of the radial curvature of the shaft for each of electrodes 12a-d of Ingle in the embodiment shown in figures 5-6 in view of the teaching of Gafni. Again, Ingle readily contemplates a variety of shape and arrangements for its electrodes with Gafni readily exhibiting that curvilinear electrodes shapes are known in the art to provide the delivery of energy to the vaginal wall with a reasonable expectation of success.
While the above combination of Ingle and Gafni provide for the electrode to be curvilinear so as to only cover a portion of the radial curvature of the shaft, the combination, and in particular the disclosure of Gafni, fails to specifically provide that the radial curvature of the RF electrode with respect to the longitudinal axis of the elongate shaft is up to 30 degrees. The Examiner is, however, of the position that it would have been an obvious consideration to one of ordinary skill in the art that the time the invention was made to have utilized a radial curvature up to 30 degrees as claimed. Specifically, the RF electrode of the combination inherently possesses an amount of radial curvature greater than zero (0) degrees based on its extent around the cylindrical shape of the distal end of the device. Thus, the Examiner is of the position that the selection of a value between greater than 0 and up to 30 degrees for the radial curvature would represent values that would be appreciated by one of ordinary skill in the art as options for the extent to which the RF electrodes spans the outer surface of the shaft. The Examiner further notes that changes of size/proportion are known to be obvious in the art. See MPEP 2144.04(I)(V)(A) setting for that a mere change in the size of a component is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 32, Ingle provides that delivering the energy pulse to treat the therapeutic zone comprises delivering, by the RF electrode, RF energy to the therapeutic zone (see col. 18; 8-21 providing for the coupling to the RF power supply for the supply of RF energy to tissue).
Regarding claim 33, Ingle provides that the RF electrode is a monopolar electrode (as in figure 11 with the electrode functioning in a monopolar manner to return the energy to the electrode pad 82).
Regarding claim 34, in view of the combination in the rejection of claim 31 above, the combined electrode would be curvilinear such that it curves radially with respect to the longitudinal axis of the elongate shaft while extending parallel with the longitudinal axis (via the curved shaped per the combination with Gafni and with the electrode having an extent along the shaft of the device of Ingle).
Regarding claim 36, Ingle provides for the step of contacting the mucosal epithelium of the female genital tissue with the energy delivery element (via the contacting of such tissue when the element 12 is brought into contact with the vaginal wall as shown in figure 6).
Regarding claim 37, Ingle, again, provides that the energy delivery element being side-mounted with respect to the longitudinal axis enables the energy delivery element to make contact with the mucosal epithelium (see figure 5 with 12 being only a side of the elongate shaft 42 and proximal to the distal end at 48).
Regarding claim 38, Ingle provides that the apparatus further comprises a cooling system (see figure 1 with the cooling system at 16, see also figures 5/6 with the cooling system connecting via 52 and extending to the distal end of the element 12), the method further comprising cooling, by the cooling system, the energy delivery element (see at least col. 12; 13-27 to provide for cooling of 12).
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) as applied to claim 27 above, and further in view of Imran (US Pat. No. 5,957,922).
Regarding claim 28, Ingle contemplates that the cooling system (16) comprises a cooling fluid or for some other manner of cooling including thermoelectric cooling (see col. 12; 14-28), and further contemplates in an alternative embodiment for a nozzle is configured to spray cooling fluid on the energy delivery element (See figures 2E and F with the opening at 25 being a nozzle to spray fluid onto the back side of 12). Ingle, while providing for the embodiment in figures 5/6 to be cooled, fails with respect to that embodiment for the inclusion of the nozzle wherein cooling the energy delivery element comprises spraying the cooling fluid on the energy delivery element. Gafni fails to cure this deficiency.
Imran discloses an exemplary device similar to the shaft and treatment tip arrangement as in Ingle and further contemplates a cooling lumen through the shaft and with a nozzle at the end of the lumen to spray cooling fluid on the energy delivery element (41 to spray fluid on the back of 46). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized the cooling lumen and nozzle arrangement as in Imran to the device of Ingle to provide for an exemplary manner of delivering cooling fluid to the treatment tip through the shaft of the device. Such ensures proper cooling fluid flow through the device while also directing cooling to the specific location of the energy delivery element.
Claim 39 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) and Garito et al. (US Pat. No. 6,458,124 B1) as applied to claim 31 above, and further in view of Imran (US Pat. No. 5,957,922).
Regarding claim 39, Ingle contemplates that the cooling system (16) comprises a cooling fluid or for some other manner of cooling including thermoelectric cooling (see col. 12; 14-28), and further contemplates in an alternative embodiment for a nozzle is configured to spray cooling fluid on the energy delivery element (See figures 2E and F with the opening at 25 being a nozzle to spray fluid onto the back side of 12). Ingle, while providing for the embodiment in figures 5/6 to be cooled, fails with respect to that embodiment for the inclusion of the nozzle wherein cooling the energy delivery element comprises spraying the cooling fluid on the energy delivery element. Neither Gafni nor Garito cure this deficiency.
Imran discloses an exemplary device similar to the shaft and treatment tip arrangement as in Ingle and further contemplates a cooling lumen through the shaft and with a nozzle at the end of the lumen to spray cooling fluid on the energy delivery element (41 to spray fluid on the back of 46). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have utilized the cooling lumen and nozzle arrangement as in Imran to the device of Ingle to provide for an exemplary manner of delivering cooling fluid to the treatment tip through the shaft of the device. Such ensures proper cooling fluid flow through the device while also directing cooling to the specific location of the energy delivery element.
Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) as applied to claim 18 above, and further in view of Strul et al. (US Pat. No. 6,358,273 B1).
Regarding claim 30, Ingle fails to provide that the treatment tip further comprises a dielectric on an exterior of the energy delivery element. Strul discloses a similar probe as that of Ingle and specifically provides for the inclusion of a dielectric on an exterior of the energy delivery element (see col. 3; 10-14 with the electrode 14 being coated with a dielectric material such as Teflon). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided a dielectric coating as in Strul to the energy delivery element of Ingle so as to provide a non-stick coating the energy delivery element. Such would aid in the energy delivery element not sticking to tissue of the vaginal wall thereby reducing the instance of unnecessary damage to the tissue.
Claim 40 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) and Garito et al. (US Pat. No. 6,458,124 B1) as applied to claim 31 above, and further in view of Strul et al. (US Pat. No. 6,358,273 B1).
Regarding claim 40, neither Ingle nor Garito provides that the treatment tip further comprises a dielectric on an exterior of the energy delivery element. Strul discloses a similar probe as that of Ingle and specifically provides for the inclusion of a dielectric on an exterior of the energy delivery element (see col. 3; 10-14 with the electrode 14 being coated with a dielectric material such as Teflon). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided a dielectric coating as in Strul to the energy delivery element of Ingle so as to provide a non-stick coating the energy delivery element. Such would aid in the energy delivery element not sticking to tissue of the vaginal wall thereby reducing the instance of unnecessary damage to the tissue.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18, 19, 21, 22, 24, 27 and 29 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5, or claims 35 and 37 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1) and Gafni et al. (US Pat. No. 6,741,895 B1).
Regarding instant independent claim 18, the instant claim is broader in some aspects while being narrower in others. The Examiner is of the position that the following correlation between the instant claim 18 and various ones of the patented claims exist:
Instant Application
US Pat. No. 8,961,511 B2
18. A method for remodeling female genital tissue using
an apparatus comprising a treatment tip, wherein the treatment tip comprises, an energy delivery element,
the method comprising:
inserting the treatment tip into an opening of a vagina of the female genital tissue;
delivering, by the energy delivery element, an energy pulse to treat a therapeutic zone within a target tissue of the female genital tissue, wherein the target tissue comprises tissue underlying a mucosal epithelium of the female genital tissue; and
Claims 1/5: A method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue
5: treatment tip, the tip including an energy delivery element
Such is implied per claim 1 with the treating a portion of the target tissue within the vagina
Per claims 1/5 with the heating of the vagina with the energy delivery element
**see the notation below that such rationale is equally applicable to patented claims 35/37**
With respect to the narrower aspects, the Examiner notes that patented claims 1/5 fail to provide for that the treatment tip comprises an elongate shaft and a thermistor, wherein the energy delivery element is side-mounted with respect to a longitudinal axis of the elongate shaft and proximal to a distal end of the elongate shaft such that the energy delivery element comprises a radio frequency (RF) electrode and the RF electrode is configured to have a radial curvature with respect to the longitudinal axis of the elongate shaft of up to 30 degrees, and wherein the thermistor is located in close proximity to the energy delivery element, and for the step of measuring, by the thermistor, a temperature of the target tissue.
However, the Examiner is of the position that such deficiencies in the patented claims can be cured by the teaching of the above cited Ingle and Gafni references as exhibited in the rejection of claim 18 under 35 U.S.C. 103 above, wherein the combination provides for the apparatus as claimed.
Therefore, it is the Examiner’s position that it would have been obvious consideration to one of ordinary skill in the art at the time the invention was made to have utilized the specific arrangement of the apparatus in the combination of Ingle and Gafni as the apparatus performing the methodology set forth in patented claims 1/5 including the treatment tip, shaft, energy delivery element and thermistor. Ingle readily provides that its apparatus is readily sufficient to provide for the requisite treatment and energy delivery of the vagina set forth in claims 1/5.
With respect to dependent claims 19-22, 24, 27 and 29, the combination of Ingle and Gafni readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
The Examiner further notes that similar rationale as applied to patented claims 1 and 5 is equally applicable to the combination of limitations set forth in patented claims 35 and 37.
Claims 25, 26, 31-33 and 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5, or claims 35 and 37 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1), Gafni et al. (US Pat. No. 6,741,895 B1) and Garito et al. (US Pat. No. 6,458,124 B1).
With respect to dependent claims 25 and 26, the combination of Ingle and Garito readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
With respect to independent claim 31, substantially the same rationale as applied in the rejection of instant independent claim 18 is equally applicable to instant independent claim 31. With respect to the narrower aspects in independent claim 31, the Examiner notes that patented claims 1/5 fail to provide for that the treatment tip comprises an elongate shaft, a connector portion at proximal end of the elongate shaft, and a thermistor, wherein the energy delivery element is side-mounted with respect to a longitudinal axis of the elongate shaft and proximal to a distal end of the elongate shaft, and wherein the thermistor is located in close proximity to the energy delivery element, and for the steps of releasably coupling the connector portion of the treatment tip to the hand piece and measuring, by the thermistor, a temperature of the target tissue. The Examiner is of the position that the combination of Ingle/Gafni/Garito readily cures the deficiencies in patented claims 1 and 5 for at least the reasoning set forth in the rejection of claim 31 under 35 U.S.C. 103 above.
With respect to dependent claims 32-34 and 36-38, the combination of Ingle and Garito readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5, or claims 35 and 37 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) and Imran (US Pat. No. 5,957,922).
With respect to dependent claim 28, the combination of Ingle and Imran readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5, or claims 35 and 37 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1), Gafni et al. (US Pat. No. 6,741,895 B1), Garito et al. (US Pat. No. 6,458,124 B1) and Imran (US Pat. No. 5,957,922).
With respect to dependent claim 39, the combination of Ingle and Imran readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5, or claims 35 and 37 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1) in view of Gafni et al. (US Pat. No. 6,741,895 B1) and Strul et al. (US Pat. No. 6,358,273 B1).
With respect to dependent claim 39, the combination of Ingle and Imran readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
Claim 40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5, or claims 35 and 37 of U.S. Patent No. 8,961,511 B2 in view of Ingle et al. (US Pat. No. 6,216,704 B1), Gafni et al. (US Pat. No. 6,741,895 B1), Garito et al. (US Pat. No. 6,458,124 B1) and Strul et al. (US Pat. No. 6,358,273 B1).
With respect to dependent claim 40, the combination of Ingle and Imran readily provides for each of the additional features set forth in each claim for at least the reasoning set forth in the action above.
Response to Arguments
Applicant's arguments filed June 26, 2026 have been fully considered but they are not persuasive.
Applicant particularly argues with respect to the amended subject matter in each of independent claims 18 and 31 on pages 8-11 of the Remarks. Applicant specifically contends on page 9 that “the combination of Ingle and Gafni fail to offer any motivation for one skilled in the art to utilize a radial curvature between 0 and 30 degrees”. Applicant continues on pages 9-10 that the reliance in the changes in size/proportion rational as set forth in MPEP 2144 is not appropriate “if the applicant has demonstrated the criticality of a specific limitation”. Applicant then cites to paragraphs [0011] and [0037] of the instant Specification to display criticality of the claimed radial curvature.
With respect to paragraph [0011], Applicant contends that the Examiner’s reliance upon case law “disregards the benefit of a radial curvature up to 30 degrees providing uniform delivery to the target tissue” due to such functioning to divide the desired treatment area into multiple contact sites along the curve of the vaginal wall. With respect to paragraph [0037], the selected portion provided in the Remarks discusses the desire for uniform fit, uniform distribution of energy, and uniform energy flux when treating tissue.
Applicant then alleges on page 11, due to Gafni’s lack of disclosure of any specific value for radial curvature, that “one of ordinary skill in the art would have to determine a degree of radial curvature based on the dimensions for the disclosed probe and active area” with such resulting in “a central angle of 65 degrees”. Applicant concludes that “the combination of Ingle and Gafni does no provide any motivation for one of ordinary skill in the art to utilized a radial curvature between 0 and 30 degrees” in light of these arguments.
This is not persuasive.
While Applicant attempts to selectively cite to each of paragraphs [0011] and [0037] in the Remarks to provide criticality of the claimed energy delivery element in the form of an RF electrode that “is configured to have a radial curvature with respect to the longitudinal axis of the elongate shaft up to 30 degrees”, the Examiner fails to find that neither of these citations provide for such criticality as alleged by Applicant especially when taken in view of both the disclosure in the remainder of each respective paragraph and in view of the balance of the balance as a whole.
First, with respect to the disclosure in paragraph [0011], the remainder of that paragraph contemplates that an energy delivery elements with widths of between 0.75 and 1.25 cm are sufficient to provide fort the desired contact with a curved vaginal wall. While [0011] does indeed point out that embodiments with an energy delivery element being radially curved are specifically contemplated, the disclosed energy delivery element is readily afforded other shapes/configurations as shown in figures 5A-C and 6A. The Examiner finds that, when taking paragraph [0011] in context with other disclosure in the Specification such as paragraphs [0035] and [0036], it would be clear to one of ordinary skill in the art that Applicant’s alleged “close fit to the curve of the vaginal wall” provided by the claimed radial curvature is actually not critical given that such a close first can be achieved by other, structurally different arrangements of the energy delivery element including a flat element as depicted in figure 6A.
Next, with respect to the disclosure in paragraph [0037], the Examiner is of the position that the totality of the disclosure set forth therein is with respect to the various different embodiments including the flat arrangement as in figure 6A and the curved arrangement as in figure 6B, and not just the curved arrangement as selectively quoted by Applicant in the Remarks. Paragraph [0037] particularly sets forth that the dimensions of both the flat and curved arrangement provide for the close fit of the electrode to the vaginal wall to ensure for the uniform fit, uniform distribution of energy, and uniform energy flux when treating the tissue. Thus, the Examiner cannot find that the recited range for the radius of curvature set forth in each of claims 18 and 31 defines a critical feature as alleged by Applicant when the entirety of the disclosure in paragraph [0037], as well as the balance of the disclosure, provides that a variety of different structural arrangements for the energy delivery element in the form of an RF electrode is sufficient to achieve the desired treatment of the vaginal wall.
To this end, the Examiner notes that each of claims 18 and 31 contemplate a range for the radial curvature of the RF electrode to be “up to 30 degrees”. Applicant’s own disclosure recites ranges of “up to 30 degrees” for the radial curvature (see, for example, paragraphs [0011], [0036], [0063]) and a preferred value for the radial curvature in some instances to be “about 30 degrees”. Accordingly, the Examiner further fails to find Applicant’s arguments as persuasive regarding the criticality to divide the intended treatment location into 10 contact sites for a 300 degree treatment area (as argued for in lines 1-2 on page 10 of the Remarks) when such is only applicable when choosing the specific radial curvature of the electrode of 30 degrees. This selection of 30 degrees appears to the Examiner to be a disclosed option for treatment and not a critical selection, especially when taken in light of the remainder of the disclosure that contemplates varying different structure/shapes for the RF electrode of the energy delivery element (flat, curved, multiple electrodes, monopolar, bipolar, etc.) as well as differing energy delivery modalities (see [0054] contemplating microwave and ultrasound in addition to RF energy). With this, the Examiner further notes that In re Goffe discusses that features which are merely preferred are not to be considered critical. See In re Goffe, 542 F.2d 564, 567, 191 USPQ 429, 431 (CCPA 1976). Accordingly, the Examiner cannot prescribe Applicant’s alleged criticality to the listed range of radial curvature when such is established as a preference in the disclosure itself, as well as is noted as a preference with respect to RF electrode shape.
Thus, the Examiner maintains that the rejection of each of claims 18 and 31 above under 35 U.S.C. 103 as unpatentable in light of the combined teaching of Ingle and Gafni does indeed establish a proper prima facie case of obviousness for at least the rationale set forth in the rejections and remarks above.
For the sake of completeness, the Examiner notes that the various rejections under 35 U.S.C. 103 and for obviousness-type double patenting have been updated in the action above due to the amendments submitted in the instant response. The Examiner is of the position that the newly proffered rejections for obviousness-type double patenting are tenable for substantially similar reasoning as discussed above with respect to the radial curvature limitations in each of claims 18 and 31.
Conclusion
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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