DETAILED ACTION
A complete action on the merits of claims 1-20 follows below.
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 Objections
Claims 1 and 9 are objected to because of the following informalities:
Delete “being further” in line of claim 1 “the RF electrode [being further] being insulated”.
Delete “and” in line 1 of claim 9 “[and] wherein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-8, 10, 12-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over RON EDOUTE (US Pub. No. 2016/0346561) in view of Parmer (US Pub. No. 2007/0233191).
Regarding Claim 1, RON EDOUTE teaches a vagina remodeling device ([0019], [0076]-[0079] and [0189]-[0198]) comprising:
a handpiece having a defined length which is adapted to be inserted into the vagina (Figs. 14-16 and [0496]-[0499]), having a distal portion and a proximal portion (Figs. 14-16, [0499]);
a radio frequency (RF) electrode mounted on the distal portion of the handpiece (electrodes 2315/2415, [0515] and Figs. 14-16);
a source of radio frequency (RF) energy which is configured to generate RF energy to the RF electrode to treat tissue within the vagina; a source of electromagnetic stimulation energy (EMagS) in the handpiece which is configured to generate (EMagS) energy in the form of a pulsed and directional magnetic field to stimulate muscles and treat the tissue within the vagina (“a heat source which can be separate or can be integral to a device for cosmetic purposes” [0376], [0064], [0072]-[0076], [0091]-[0096] and [0522]-[0524]);
a controller configured to: (1) cause the source of RF to generate RF energy; (2) cause the source of EMagS energy to generate EMagS energy within the body orifice; and, (3) regulate the application of RF energy and EMagS energy to treat tissue within the vagina ([0031], [0043], [0126], [0212]-[0222], [0497]-[0525]);
although RON EDOUTE teaches “controlling each pair separately” in [0062] and providing individual conductors to each electrodes as seen in Figs. 19-20 and thereby Examiner takes a position that the electrodes are electrically separated and insulated from each other, RON EDOUTE does not specifically teach the RF electrode [being further] being insulated with biocompatible material. Furthermore, RON EDOUTE teaches the distal section of the handpiece is straight and not curved to match the inside contours of the human vagina.
In the same field of invention, Parmer teaches a vaginal remodeling device comprising at least one electrode and non-conductive insulation material where Parmer further teaches “Conductive portion 35 comprises a metal, exemplary metals including copper, gold, silver, and aluminum. Dielectric portion 36 may comprise a variety of different materials including, by way of example, polyimide, Teflon (RTM) and the like, silicon nitride, polysilanes, polysilazanes, polyimides, Kapton and other polymers, antenna dielectrics and other dielectric materials well known in the art” in [0040] and also teaches “the dimensions and configuration of the energy delivery element are adapted to the optimize contact, particularly with the vaginal wall. The width of the energy delivery element is between 0.75 and 1.25 cm. Such a width is sufficient to engage the curved wall of the vagina in a manner that is sufficiently flat and parallel that the quality of contact across the face of the energy delivery element is substantially equal, without increased pressure, closer contact, or distortion along the edges of the element. Such a close contact allows for a uniform delivery of energy into the underlying target tissue. In some embodiments, the face of the energy delivery element is radially curved (with respect to the longitudinal axis of the tip) within the width of the element so as to create an arc of up to 30 degrees. Such curvature is also adapted to make parallel contact with the vaginal wall” in [0011].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to insulate the electrodes from each other with a similar biocompatible material to provide a safe and effective working end as well as adding a curvature to the distal end of the device of RON EDOUTE in order for the curvature to be adapted to make parallel contact with the vaginal wall to create optimize contact with the vaginal wall for a uniform delivery of energy and better outcome of treatment.
Regarding Claim 2, RON EDOUTE teaches wherein the controller is configured to cause the source of RF energy and the source of EMagS energy to be activated one of: simultaneously or sequentially ([0091] and [0230]).
Regarding Claim 3, RON EDOUTE teaches wherein the distal section is configured to be inserted into the vagina and the proximal section is adapted to remain outside the vagina during the treating of the vagina, and wherein the distal section and the proximal section being separable (Figs. 14-16 and [0497]-[0498]).
Regarding Claim 4, RON EDOUTE teaches wherein the distal section is of: a disposable material or a sterilizable material ([0497]-[0499]).
Regarding Claim 5, RON EDOUTE teaches wherein the proximal section comprises one or more connections through a cable to one or more sources of power to power the source of RF energy and the source of EMagS energy ([0499]).
Regarding Claim 6, RON EDOUTE teaches wherein the interior of the distal portion of the handpiece is substantially hollow and further comprising a plurality of apertures from the interior of the handpiece through to the outside of the handpiece, further comprising a substance contained within or insertable into the interior of the handpiece which may be pumped from the interior to the exterior of the handpiece during treatment (“a mechanism for delivering heating or cooling fluids, is not shown” [0497], “connection provided by the proximal portion (2340) includes a mechanical connection and electrical communication; it can also include a fluid connection” and “at least one of the electrodes additionally comprises a hypodermic syringe for penetrating into subcutaneous tissue. By means of such a syringe, a substance with appropriate activity may be injected into the tissue during treatment. Non-limiting examples of such substances include a dye to absorb light in embodiments that use optical means for effecting tissue diathermy, a muscle relaxant, a local anesthetic” in [0431] and [0440], in addition, Parmer also teaches the interior of the device includes a space configured to allow a substance to be delivered to the treatment area).
Regarding Claim 7, RON EDOUTE in view of Parmer teaches wherein the substance comprises HA (Hyaluronic Acid) (the hollow space in the handpiece allowing a substance to be effectively delivered to the treatment area; therefore, it would allow any substance such as HA (Hyaluronic Acid) to be delivered to the treatment area).
Regarding Claim 8, RON EDOUTE teaches wherein the RF electrode is one of: monopolar or bipolar ([0523]-[0524], Figs. 19-20 and [0545], also see [0009] and [0032] of Parmer).
Regarding Claim 10, RON EDOUTE teaches further comprising distance markers on an outer surface of the device, whereby an operator may determine the extent of the depth on the distal portion of the device into a person's vagina (Fig. 15).
Regarding Claim 12, RON EDOUTE teaches a method of remodeling a vagina ([0019], [0076]-[0079] and [0189]-[0198]) comprising:
providing a handpiece having a defined length which is adapted to be inserted into the vagina (Figs. 14-16 and [0496]-[0497]), having a distal portion and a proximal portion (Figs. 14-16);
providing a radio frequency (RF) electrode mounted on the distal portion of the handpiece (electrodes 2315/2415, [0515] and Figs. 14-16);
providing a source of radio frequency (RF) energy which is configured to generate RF energy to the RF electrode to treat tissue within the vagina; providing a source of electromagnetic stimulation energy (EMagS) in the handpiece which is configured to generate (EMagS) energy in the form of a pulsed and directional magnetic field to stimulate muscles and treat the tissue within the vagina (“a heat source which can be separate or can be integral to a device for cosmetic purposes” [0376], [0064], [0072]-[0076], [0091]-[0096] and [0522]-[0524]);
providing a controller, the controller: (1) causing the source of RF to generate RF energy; (2) causing the source of EMagS energy to generate EMagS energy within the body orifice; and, (3) the controller regulating the application of RF energy and EMagS energy to treat tissue within the vagina ([0031], [0043], [0126], [0212]-[0222], [0497]-[0525]);
although RON EDOUTE teaches “controlling each pair separately” in [0062] and providing individual conductors to each electrodes as seen in Figs. 19-20 and thereby Examiner takes a position that the electrodes are electrically separated and insulated from each other, RON EDOUTE does not specifically teach the RF electrode [being further] being insulated with biocompatible material. Furthermore, RON EDOUTE teaches the distal section of the handpiece is straight and not curved to match the inside contours of the human vagina.
In the same field of invention, Parmer teaches a vaginal remodeling device comprising at least one electrode and non-conductive insulation material where Parmer further teaches “Conductive portion 35 comprises a metal, exemplary metals including copper, gold, silver, and aluminum. Dielectric portion 36 may comprise a variety of different materials including, by way of example, polyimide, Teflon (RTM) and the like, silicon nitride, polysilanes, polysilazanes, polyimides, Kapton and other polymers, antenna dielectrics and other dielectric materials well known in the art” in [0040] and also teaches “the dimensions and configuration of the energy delivery element are adapted to the optimize contact, particularly with the vaginal wall. The width of the energy delivery element is between 0.75 and 1.25 cm. Such a width is sufficient to engage the curved wall of the vagina in a manner that is sufficiently flat and parallel that the quality of contact across the face of the energy delivery element is substantially equal, without increased pressure, closer contact, or distortion along the edges of the element. Such a close contact allows for a uniform delivery of energy into the underlying target tissue. In some embodiments, the face of the energy delivery element is radially curved (with respect to the longitudinal axis of the tip) within the width of the element so as to create an arc of up to 30 degrees. Such curvature is also adapted to make parallel contact with the vaginal wall” in [0011].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to insulate the electrodes from each other with a similar biocompatible material to provide a safe and effective working end as well as adding a curvature to the distal end of the device of RON EDOUTE in order for the curvature to be adapted to make parallel contact with the vaginal wall to create optimize contact with the vaginal wall for a uniform delivery of energy and better outcome of treatment.
Regarding Claim 13, RON EDOUTE teaches wherein the controller causes the source of RF energy and the source of EMagS energy to be activated one of: simultaneously or sequentially ([0091] and [0230]).
Regarding Claim 14, RON EDOUTE teaches wherein the handpiece comprises two sections: a distal section adapted to be inserted into the vagina and a proximal section, the distal section and the proximal section being separable (Figs. 14-16 and [0497]-[0498]).
Regarding Claim 15, RON EDOUTE teaches wherein the distal section is of: a disposable material or a sterilizable material ([0497]-[0499]).
Regarding Claim 16, RON EDOUTE teaches wherein the proximal section comprises one or more connections to one or more sources of power to power the source of RF energy and the source of EMagS energy ([0499]).
Regarding Claim 17, RON EDOUTE teaches wherein the interior of the distal portion of the handpiece is substantially hollow and further comprising a plurality of apertures from the interior of the handpiece through to the outside of the handpiece, further comprising a substance contained within or insertable into the interior of the handpiece which may be pumped from the interior to the exterior of the handpiece during treatment (“a mechanism for delivering heating or cooling fluids, is not shown” [0497], “connection provided by the proximal portion (2340) includes a mechanical connection and electrical communication; it can also include a fluid connection” and “at least one of the electrodes additionally comprises a hypodermic syringe for penetrating into subcutaneous tissue. By means of such a syringe, a substance with appropriate activity may be injected into the tissue during treatment. Non-limiting examples of such substances include a dye to absorb light in embodiments that use optical means for effecting tissue diathermy, a muscle relaxant, a local anesthetic” in [0431] and [0440], in addition, Parmer also teaches the interior of the device includes a space configured to allow a substance to be delivered to the treatment area).
Regarding Claim 19, RON EDOUTE teaches wherein the source of RF energy operates at frequencies up to 6 Mhz ([0212], [0296] and [0320]).
Regarding Claim 20, RON EDOUTE teaches wherein the source of RF energy operates at frequencies up to 6 Mhz ([0212], [0296] and [0320]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over RON EDOUTE in view of Parmer as applied above and further in view of Bagwell (US Pub. No. 2014/0309683).
Regarding Claim 9, RON EDOUTE in view of Parmer teaches the invention as applied above, but neither alone or in combination teach wherein a proximal end of the proximal portion includes a slip ring, the slip ring permitting the device to be rotated while in position in a vagina so as to avoid kinking and twisting of a cable attached to the proximal end.
In the same field of coupling electrical wires to a handpiece, Bagwell teaches coupling electrical wires from the controller to the handle of the surgical instrument through a slip ring 48 in order to allow rotation without kinking or breakage and also to avoid tangling or additional torsional stress placed on those electrical connections in [ 0062]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a slip ring to couple the electrical wires to the handle of RON EDOUTE in order to allow rotation of the device without kinking or breakage and also to avoid tangling or additional torsional stress placed on those electrical connections as Bagwell teaches.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over RON EDOUTE in view of Parmer as applied above and further in view of Azar (US Pub. No. 2016/0121112).
Regarding Claim 11, RON EDOUTE in view of Parmer teaches the invention as applied above, but neither alone or in combination teach further comprising a source of electrical muscle stimulation (EMS) within the device, the EMS source being configured to be operable together with or separate from the sources of RF and EMagS.
In the same field of invention, Azar teaches a controller coupled to different sources of energy such as RF energy and “an electrical muscle stimulation signal (EMS) which is purposed and designed when activated to contract the vaginal smooth muscle around a vaginal probe” in [0034] in order to assist in treatment for vaginal tightening.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use an electrical muscle stimulation signal (EMS) with the system of RON EDOUTE in order to contract the vaginal smooth muscle around the treatment probe to assist in treatment for vaginal tightening as Azar teaches.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over RON EDOUTE in view of Parmer as applied above and further in view of EBBUTT (US Pub. No. 2016/0324576).
Regarding Claim 18, RON EDOUTE teaches wherein the substance comprises “a dye to absorb light in embodiments that use optical means for effecting tissue diathermy, a muscle relaxant, a local anesthetic, etc” in [0440], so although it is configured to inject HA (Hyaluronic Acid) into tissue, RON EDOUTE does not specifically teach the method of injecting HA (Hyaluronic Acid) into tissue.
In the same field of invention, Ebbutt teaches “the surgeon is able to inject saline and/or hyaluronic acid with added marker dye between tissues layers in order to distend and mark the position of a lesion to be treated” in [0079]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to inject hyaluronic acid with the added dye at the target tissue site to not only enhance the target area to be visualized by the surgeon as RON EDOUTE teaches but also provide for a conductive for RF current and/or lubricate the target area.
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794