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 .
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Schwarz et al. (hereinafter ‘Schwarz’, U.S. PGPub No. 2018/0345012).
In regards to claim 1, Schwarz discloses a treatment tip for treating vaginal cavity, wherein the treatment tip is configured to be detachably connected to a handle, and the treatment tip comprises: a flexible shell being inflatable (See abstract, [0104]: "One or more detachable parts may be joined to one or more attaching elements which may contain a handle."), and a support component installed in the flexible shell to support the flexible shell ([0170]: "Optionally, the applicator may be in a form of a thin structure e.g. a flexible structure containing an energy delivery element inserted into the tissue in the rolled form, where it may be unrolled.").
In regards to claim 2, Schwarz discloses that one of the treatment tip and the handle is provided with a snap block, and the other of the treatment tip and the handle is provided with a snap slot ([0162]: "FIG. 3I shows the exemplary connection of male connector 319 and female connector 323. The male connector 319 may be an edge connector, pin header, insulation-displacement contact or Berg connector.").
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In regards to claim 3, Schwarz discloses that the handle is provided with an installation groove, and the installation groove is configured to accommodate at least part of the treatment tip, a groove wall of the installation groove is provided with the snap slot, and the treatment tip is provided with the snap block, and the snap slot comprises a channel slot for the snap block to extend into and a clamping slot extending along a circumference of the handle, and the channel slot is communicated with the clamping slot ([0162]: "FIG. 3H shows internal applicator to be detached from the attaching part 311, which may be integral part of the device and/or also detachable from the device. The internal applicator 301 may be coupled to the attaching part 311 by the male connector 319 shown on the internal applicator. Attaching part 311 may include female connector which may be coupled to the male connector 319 located on the applicator 301.").
In regards to claim 4, Schwarz discloses that the treatment tip further comprises a hard circuit board and a plurality of electrode sheets, the hard circuit board is installed on the flexible shell to support the flexible shell, and the electrode sheets are installed on the hard circuit board and exposed on an outer peripheral wall of the flexible shell, the plurality of electrode sheets are provided at intervals along a length direction of the flexible shell ([0109]: "Central control unit 103 may be printed circuit board which may include processor.", [0150]: "FIG. 3B shows another embodiment, where the internal applicator 301 may carry one or more ring-shaped circular and/or semicircular energy delivery elements 108, e.g. bipolar or monopolar electrodes, where complementary pairs of ring-shaped circular electrodes encircling the applicator may be positioned close to each other.").
In regards to claim 5, Schwarz discloses that the flexible shell is provided with an inflatable cavity, and the support component comprises a support portion extending into the inflatable cavity to support the flexible shell ([0153]: "In FIG. 3D the internal applicator 301 may include one or more expandable elements 310 made from elastic material, where one or more energy delivery elements 108 is located on the surface of the expandable element 310.").
In regards to claim 6, Schwarz discloses that the treatment tip further comprises an installation seat installed on the flexible shell, and the installation seat is provided with an inflation hole communicated with the inflatable cavity (See Fig. 3I), 'the handle is provided with an abutting pillar extending into the inflation hole, and the abutting pillar is provided with a gas delivery port ([0121]: "A substance, which may be a liquid, gel and/or gas, may be dispensed on the tissue and/or the part of the applicator. The substance may be dispensed before, during or after treatment. The substance (e.g. hydrating gel or water) may lower friction between the applicator and the tissue or improve conductivity for better energy transfer.").
In regards to claim 7, Schwarz discloses that the treatment tip further comprises a sealing gasket installed on the installation seat, and the sealing gasket comprises a gasket body and a sealing ring, the gasket body is provided on a side of the installation seat away from the handle, and the sealing ring is configured to extend along a wall surface of the inflation hole and is exposed at the inflation hole ([0174]: "The external applicator and/or one or more its parts may be positioned in a static position or it may be moved during treatment. Portions of the device may be moved and repeatedly stopped in predetermined positions during treatment. The static position in the predetermined position may be provided by a locking mechanism 508. The locking mechanism may be mechanical e.g. latching member, screw mechanism, self-locking mechanism such as worm gearing, electromagnetic and/or magnetic e.g. electromagnetic brake.").
In regards to claim 8, Schwarz discloses that the sealing ring is provided with an outer flange ([0174]: "The external applicator and/or one or more its parts may be positioned in a static position or it may be moved during treatment. Portions of the device may be moved and repeatedly stopped in predetermined positions during treatment. The static position in the predetermined position may be provided by a locking mechanism 508. The locking mechanism may be mechanical e.g. latching member, screw mechanism, self-locking mechanism such as worm gearing, electromagnetic and/or magnetic e.g. electromagnetic brake.").
In regards to claim 9, Schwarz discloses that the treatment tip further comprises a sealing member, and the sealing member is elastically abutted against the sealing gasket to seal the inflation hole, in response to that the abutting pillar extends into the inflation hole, the abutting pillar is abutted against the sealing member to open the inflation hole ([0162]: "The communication between attaching part 311 and the user interface 104, energy generator 106, central control unit 103 and/or device may be provided by wire and/or wirelessly. FIG. 31 shows the exemplary connection of male connector 319 and female connector 323. The male connector 319 may be an edge connector, pin header, insulation-displacement contact or Berg connector.").
In regards to claim 10, Schwarz discloses that the flexible shell is provided with a port communicated with the inflatable cavity, and the port is provided with an extension ring; the installation seat is provided with a receiving groove for receiving the extension ring, and a periphery of the receiving groove is provided with an annular protrusion for abutting against the flexible shell ([0153]: "In FIG. 3D the internal applicator 301 may include one or more expandable elements 310 made from elastic material, where one or more energy delivery elements 108 is located on the surface of the expandable element 310. FIG. 3D shows more energy delivery elements 108 with different shapes. One or more expandable elements 108 may also be detachable parts.").
In regards to claim 11, Schwarz discloses a plurality of annular protrusions are provided at intervals around a periphery of the installation seat ([0157]: "The insertable part 318 may include plurality of energy delivery elements 108 (e.g. monopolar, bipolar and/or unipolar electrodes) which may be activated in different manner according to configuration. In one example, all energy delivery elements may be activated simultaneously i.e. in one time segment. In another example one energy delivery element may be activated after another energy delivery element, wherein said energy delivery elements may be located one another or there may be another at least one non-activated energy delivery elements between them. In still another example one group of energy delivery elements (i.e. more than one, e.g. pair) may be activated after another group of energy delivery elements, wherein said groups of energy delivery elements may be located side by side or there may be another at least one non-activated group of energy delivery elements between them. The energy delivery elements may be spaced apart from each other and parallel to each other and perpendicular to the longitudinal axis of the device.").
In regards to claim 12, Schwarz discloses that the treatment tip further comprises an installation member installed at the port, the installation member comprises an extension barrel for connecting the installation seat, and a thimble embedded in the flexible shell ([0162]: "FIGS. 3G show internal applicator 301 as a detachable part couplable to the attaching part 311. FIG. 3H shows internal applicator to be detached from the attaching part 311, which may be integral part of the device and/or also detachable from the device. The internal applicator 301 may be coupled to the attaching part 311 by the male connector 319 shown on the internal applicator. Attaching part 311 may include female connector which may be coupled to the male connector 319 located on the applicator 301.").
In regards to claim 13, Schwarz discloses that the support component further comprises a base installed on the installation seat, the support portion is provided on the base, and the installation member is configured to pass through the base and is engaged with the installation seat ([0162]: "The communication between attaching part 311 and the user interface 104, energy generator 106, central control unit 103 and/or device may be provided by wire and/or wirelessly. FIG. 31 shows the exemplary connection of male connector 319 and female connector 323. The male connector 319 may be an edge connector, pin header, insulation-displacement contact or Berg connector.").
In regards to claim 15, Schwarz discloses that the treatment tip further comprises an adapter plate, and the adapter plate is installed on the support component, the adapter plate is electrically connected to the hard circuit board, and the adapter plate is configured to electrically connect with the handle ([0102]: "Optionally, the utilization of one or more detachable parts may provide the applicator with none, one or more energy delivery elements located based on the operator's need. Such methods and devices may provide the applicator with adaptive detachable parts resolving problems of ineffective and uncomfortable treatment.").
In regards to claim 16, Schwarz discloses a system for treating vaginal cavity, comprising a treatment tip of any one of claims 1 to 15 and a handle, wherein the handle is detachably connected to the treatment tip (See abstract, [0104]: "One or more detachable parts may be joined to one or more attaching elements which may contain a handle.").
In regards to claim 17, Schwarz discloses that the handle is provided with a limiting pillar configured to extend into and out of the treatment tip, the treatment tip is provided with a limiting hole for accommodating the limiting pillar, and the limiting hole is offset from a rotation axis of the handle ([0172]: "One and more parts of the external applicator and/or mechanical arm may contain and/or be attached to a motor unit 506 providing movement. Optionally, one or more portions of the device may be moved manually. The applicator may be moveable in one or more axis of Cartesian coordinate system.").
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarz, in view of Liu et al. (hereinafter ‘Liu’, U.S. PGPub No. 2020/0238072.
In regards to claim 14, Schwarz discloses the invention substantially as described in claim 13.
However, Schwarz does not disclose that one of the installation member and the installation seat is provided with a hook piece, and the other one is provided with a buckle piece being engaged with the hook piece.
Liu et al. describes a treatment device that possesses an electrode assembly disposed on a flexible sleeve with a detachable handle. The invention in Liu describes an installation member and the installation seat is provided with a hook piece, and the other one is provided with a buckle piece being engaged with the hook piece ([0046]: “As shown in FIG. 3 and FIG. 6, the outer shell 121 may be further provided with at least one grabbing buckles 1214, and the flexible sleeve 13 is correspondingly provided with at least one buckle holes 133…. Therefore, it is easier to hook the grabbing buckle 1214 in the buckle holes 133.”). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the treatment device to use a hook piece, and the other one is provided with a buckle piece being engaged with the hook piece, as taught by Liu, as doing so would provide the required degree of freedom for the installation member while also providing properties for simple assembly of the device ([0046]: " In this way, the degree of freedom of the flexible sleeve 13 in the extension directions of the long sides 111 may be further limited. It should be noted that the grabbing buckle 1214 may be arranged on the outer shell 121 because the outer shell 121 has been already connected to the mounting heads 114 by screw, without simultaneously connected with the inner shell 122. Therefore, it is easier to hook the grabbing buckle 1214 in the buckle holes 133.").
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/MICHAEL J LAU/Examiner, Art Unit 3796
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