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 .
Response to Amendment
The amendment filed 15 December 2025 has been entered. Claims 1, 3-4, 6-10, 15-17, and 19-20 are currently amended. Claim 2 is canceled. Claims 1 and 3-20 are pending in the application. Applicant’s amendments to the drawings and claims have overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 16 July 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the bladder cavity" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 15-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra et al. (US PGPub No. 2015/0157391), hereinafter Ben-Ezra, in view of Krimsky et al. (US PGPub No. 2020/0398048), hereinafter Krimsky.
Regarding claim 1, Ben-Ezra teaches an intravesical catheter used for a minimally invasive and permeable RF diagnosis and treatment equipment (Fig. 1: device 100; par. 0093: “device 100 adapted for insertion through the human urethra according to embodiments of the invention”), wherein, the catheter, which comprises a tube body (Fig. 1: flexible shaft 120) and an RF electrode array (Fig. 1: electrodes 132), has a retractable cavity (Fig. 1: inflatable balloon 110), and the RF electrode array is attached to an outer surface of the retractable cavity (0093: “one or more electrodes 132 disposed on the surface of the balloon 110”).
Ben-Ezra does not explicitly teach a flexible protecting net surrounding outside of the RF electrode array, having a connector connected with the tube body and multiple holes; wherein the flexible protecting net is made of elastic material; wherein elastic pressure is always applied to the RF electrode array by the flexible protecting net, keeping the RF electrode array flat on the outer surface of the retractable cavity; and wherein when the retractable cavity expands from a contraction state to an expansion state, the flexible protecting net expands accordingly, and RF electrodes of the RF electrode array are completely or partially aligned with the holes. However, in an analogous art, Krimsky teaches a catheter with an expandable energy delivery assembly having a flexible protecting net surrounding outside of an RF electrode array, having a connector connected with the tube body and multiple holes; wherein the flexible protecting net is made of elastic material (Fig. 22 and par. 0181: “insulation material 300 covering a portion of the energy delivery body 208 (indicated by shading) leaving another portion exposed which is considered the electrode 212 […] insulation could be attained by masking portions of the energy delivery body 208, such as a spiral-shaped basket, when the body 208 is expanded. This may be achieved by positioning the energy delivery body 208 within a balloon or other compliant masking material wherein the material has one or more portions removed, such as creating one or more windows”);
wherein elastic pressure is applied to the RF electrode array by the flexible protecting net, keeping the RF electrode array flat on the outer surface of the retractable cavity, and when the retractable cavity expands from a contraction state to an expansion state, the flexible protecting net expands accordingly (par. 0181: “positioning the energy delivery body 208 within a balloon or other compliant masking material […] Expansion of the energy delivery body 208 presses the body 208 against the material, and optionally expands the material”), and RF electrodes of the RF electrode array are completely or partially aligned with the holes (par. 0181: “Portions of the energy delivery body 208 exposed through the one or more windows would be able to deliver energy while covered portions would be insulated”).
Krimsky teaches that insulating the RF electrode array in this manner allows for focal energy delivery (par. 0181: “Portions of the energy delivery body 208 are insulated so as to reduce the size and contour of the electrode 212 for focal delivery”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the catheter of Ben-Ezra with the compliant masking material of Krimsky in order to allow for focal energy delivery, as taught by Krimsky.
Regarding claim 3, the combination teaches the device of claim 1 as described previously. Krimsky further teaches wherein, the flexible protecting net comprises a plurality of connecting parts, and two adjacent holes are connected through the connecting part; when the retractable cavity is in the contraction state, the RF electrodes of the RF electrode array are all pressed by the connecting parts (Fig. 23: two holes 212a and 212b connected by connecting parts pressing on wires 220; par. 0181: “positioning the energy delivery body 208 within a balloon or other compliant masking material wherein the material has one or more portions removed, such as creating one or more windows. Expansion of the energy delivery body 208 presses the body 208 against the material, and optionally expands the material;” par. 0182: “insulation material 300 covering a portion of the energy delivery body 208 (indicated by shading) leaving two portions exposed creating a first electrode 212a and a second electrode 212b”).
Regarding claim 15, the combination teaches the device of claim 1 as described previously. Ben-Ezra further teaches wherein the RF electrode array is supported by a flexible film, wherein one end of the flexible film is fixed on an outer surface of the retractable cavity and the other end is not fixed (par. 0150: “The electrodes 132 may be made of an extensible material, for example a thin metal strip of stainless steel, so that when the balloon 110 inflates, they elongate as needed, and remain so. Alternatively, the electrodes 132 could be made of a flexible conductor, such as various graphene based conductors;” examiner interprets the lower side of a thin extensible electrode as a flexible film with one end fixed to the outer surface of balloon 110, with the upper side not fixed).
Regarding claim 16, the combination teaches the device of claim 1 as described previously. Ben-Ezra further teaches wherein the two ends of the catheter are respectively provided with a first body fluid input and output port and a second body fluid input and output port communicated with each other; the retractable cavity is arranged between the first body fluid input and output port and the second body fluid input and output port and closer to the second body fluid input and output port (Fig. 9A: cooling fluid lumen 134 opening into balloon 110); one end close to the first body fluid input and output port is connected with a refrigerant injection port passing through the catheter and connected with the retractable cavity, and the retractable cavity is filled with refrigerant (par. 0112: “a cooling fluid lumen 134 for the introduction and removal of a cooling fluid such as cooled saline. The balloon 110A comprises an inner compartment 111A for inflation and an outer compartment 111B which can be filled with the cooling fluid to cool the balloon 110A when the electrodes 132 have heated”).
Regarding claim 19, the combination teaches the device of claim 1 as described previously. Ben-Ezra further teaches further comprising an RF power supply and an intelligent controller, wherein the RF power supply is electrically connected with the RF electrode array through the intelligent controller (par. 0094: “a system for ablating a hollow bodily organ such as the bladder, the system comprising the device 100 and a processor coupled to the device 100. The processor may be configured to run code to cause the device 100 to electrically map the bladder when placed therein, to further determine a predetermined ablation pattern based on the mapped electrical activity, and to further operate the device 100 to selectively energize the electrodes 132 to create the ablation pattern on the inner wall of the bladder”).
Claims 4, 6, 10-11, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Krimsky and further in view of Vrba et al. (US PGPub No. 2017/0348049), hereinafter Vrba.
Regarding claim 4, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. The combination is silent with respect to the specific compliant masking material and does not explicitly teach wherein the flexible protecting net is made of one or more materials of siloxane, polyurethane, silica gel, latex, carbon fiber, polyethylene, cross-linked polyethylene, conductive siloxane, polyethylene terephthalate, semi permeable film and polyamide. However, in an analogous art, Vrba teaches an RF catheter with a flexible protecting sleeve made of polyurethane (par. 0236: “Materials for the sleeve 414 could include polyurethanes, nylon, Polyethylene Terephthalate (PET) or others”). In light of Vrba’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select polyurethane as the material for the flexible protecting net of the combined reference, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 6, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. The combination does not explicitly teach various sizes of the holes of the flexible protecting net. However, Vrba teaches multiple potential sizes for holes for a flexible protecting sleeve (Fig. 8F and par. 0237: “In some embodiments, the windows or fenestrations 860 are sized to be larger than the electrodes, which may allow the gap to be filled with elastomeric adhesive material so as to provide increased securement and strain relief. In other embodiments, the windows or fenestrations 860 are sized to be smaller than the electrodes, which may also provide enhanced strain relief and secure attachment”). In light of the fact that multiple sizes for the holes are known from Vrba’s teaching, it would have been obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select various sizes for the holes of the flexible protecting net, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claims 10-11, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. The combination does not teach wherein a surface of the flexible protecting net or the RF electrode array or the retractable cavity is coated with a coating lubricant, and wherein the coating lubricant is dry or liquid. However, Vrba teaches providing a dry or liquid lubricant on a surface of an ablation catheter in order to reduce undesired motion (par. 0422: “In various embodiments, undesired motion of neuromodulation catheters (e.g., ablation catheters) can be reduced by substantially reducing the friction between the neuromodulation catheter and the guide catheter within which the neuromodulation catheter is inserted. The reduction of friction can be achieved, for example, by means of a hydrophobic (e.g., fluorine-based) lubricant or coating”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a dry or liquid lubricant on a surface of the flexible protecting net or the RF electrode array or the retractable cavity of the combined reference, as taught by Vrba, in order to reduce undesired motion, as taught by Vrba.
Regarding claim 17, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. The combination does not teach wherein, when the retractable cavity expands from the contraction state to the expansion state, a size of each hole is larger than that of each RF electrode, and some RF electrodes of the RF electrode array penetrate from the holes. However, Vrba teaches wherein, when the retractable cavity expands from the contraction state to the expansion state, a size of each hole is larger than that of each RF electrode, and some RF electrodes of the RF electrode array penetrate from the holes, which can provide increased securement and strain relief (par. 0237: “the windows or fenestrations 860 are sized to be larger than the electrodes, which may allow the gap to be filled with elastomeric adhesive material so as to provide increased securement and strain relief”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the holes of the combined reference to be larger than each electrode, as taught by Vrba, in order to provide increased securement and strain relief, as taught by Vrba.
Regarding claim 18, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the connector is connected with the retractable cavity of the tube body. However, Vrba teaches wherein the flexible protecting sleeve and retractable cavity are connected together in order to maintain inflation pressure inside the retractable cavity (Fig. 4: flexible sleeve 414 connected to shaft 405 and balloon 401; par. 0236: “The balloon 401 and sleeve 414 may be bonded together so that inflation pressure inside the balloon 401 is maintained”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combined reference by connecting the connector of the flexible protecting net to the retractable cavity of the tube body, as taught by Vrba, in order to maintain inflation pressure inside the retractable cavity, as taught by Vrba.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Krimsky and Vrba and further in view of Tanioka et al. (US PGPub No. 2008/0188832), hereinafter Tanioka.
Ben-Ezra in view of Krimsky and Vrba teaches the device of claim 4 as described previously. The combination does not explicitly teach wherein the flexible protecting net comprises a plurality of sequentially connected segments with different materials. However, in a related catheter art, Tanioka teaches that high-functioning medical catheters should have a relatively flexible distal portion and a relatively stiff proximal portion in order to improve kinking resistance (par. 0006 and par. 0021: “The medical catheter here is suitable for use as a high-functioning catheter and is composed of a proximal portion and a distal portion, the proximal portion being a resin tube of composite material having a gradually decreasing high stiffness, and the proximal portion and the distal portion being connected together in such a way as to improve kinking resistance”) and that a gradually changing stiffness can be achieved by using differing materials (par. 0028: “Both or either of the inner layer and the outer layer should have gradually changing stiffness. This object is achieved by combining together a plurality of materials differing in stiffness or by using materials differing in thickness”). In light of Tanioka’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the flexible protecting net of the combined reference with a plurality of sequentially connected segments (from proximal to distal) with different materials, as taught by Tanioka, in order to improve kinking resistance, as taught by Tanioka.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Krimsky and further in view of Tanioka.
Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously but does not explicitly teach wherein, thickness of different areas of the flexible protecting net is different. The combination in view of Tanioka teaches the limitation of claim 7 for the same reasons set forth in the rejection of claim 5, that is, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the flexible protecting net of the combined reference with different areas of thickness in order to improve kinking resistance, as taught by Tanioka.
Claims 8-9, 12-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra in view of Krimsky and in further in view of Govari et al. (US PGPub No. 2022/0110675), hereinafter Govari.
Regarding claim 8 and 12-14, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. The combination is silent with respect to connectors at a relative front end and back end of the flexible protecting net, wherein a fixed structure comprising a raised ring or annular limiting groove is provided at a position where the retractable cavity is connected with the flexible protecting net. However, in an analogous art, Govari teaches a balloon ablation catheter connected to an outer structure via connectors at a relative front (distal) end and back (proximal) end (Fig. 3A: distal connector 85 and proximal connector 79 connecting balloon 65 with splines 55), wherein a raised ring or annular limiting groove is provided at a position where the retractable cavity is connected with the flexible protecting net (Fig. 4: distal securing ring 87; par. 0080: “the inflatable balloon 65 and the splines 55 may be secured between the distal connector 85 and distal securing ring 87 using a pressure fit and/or any suitable adhesive;” wherein the securing ring performs the same function as an annular limiting groove such that they are functional equivalents). To provide the device of the combined reference with distal and proximal connectors, as taught by Govari, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (pressure fit or adhesive) with no change in their respective functions, and the combination would have yielded nothing more than predictable results, that is, one skilled in the art would have recognized that the distal and proximal connectors used in Govari would hold the flexible protecting net and retractable cavity together and prevent movement of one relative to the other.
Regarding claim 9, Ben-Ezra in view of Krimsky teaches the device of claim 1 as described previously. Krimsky further teaches wherein a connector tightly encloses a front end of the tube body (Fig. 22: distal end constraint 224), but the combination does not explicitly teach wherein only a front end of the flexible protecting net is provided with the connector. However, Govari further teaches wherein a proximal connector is optional (par. 0088: “the catheter 100 includes a support element such as the distal connector 85 connected to the distal end of the inflatable balloon 102 and the distal end of the expandable basket assembly 35 (and/or the proximal connector 79 connected to the proximal end of the inflatable balloon 102 and the proximal end of the expandable basket assembly 35)”). In light of Govari’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide a connector at only the front end of the flexible protecting net, since it has been held that omission of an element and its function in a combination where the remaining elements perform the same functions as before involves only routine skill in the art. In re Karlson, 136 USPQ 184.
Regarding claim 20, Ben-Ezra in view of Krimsky teaches the device of claim 19 as described previously. The combination does not teach further comprising a signal detector and a signal transmitter; wherein the signal detector is arranged outside a bladder cavity when using the diagnosis and treatment equipment, and the catheter is integrated with the signal transmitter; and the signal detector is used to detect a signal sent by the signal transmitter and locate or diagnose a lesion in three dimensions according to the signal. However, Govari further teaches that magnetic location sensing for catheters is known in the art, comprising a signal detector outside a patient’s body (par. 0002: “magnetic field generators are typically placed at known locations external to the patient”) and the catheter is integrated with a signal transmitter (par. 0002: “A magnetic field sensor within the distal end of the probe generates electrical signals in response to these magnetic fields, which are processed to determine the coordinate locations of the distal end of the probe”) in order to locate a lesion in three dimensions. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the system of the combined reference with a magnetic location sensing system, as taught by Govari, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (installing magnetic field generators and sensors) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, that is, one skilled in the art would have recognized that adding a magnetic location sensing system would allow a catheter and any associated lesions to be tracked in three dimensions.
Response to Arguments
Applicant’s arguments, filed 15 December 2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claim, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ben-Ezra and Krimsky. As described previously, Ben-Ezra teaches an intravesical balloon catheter, and Krimsky teaches an elastic flexible protecting net that applies elastic pressure to the RF electrode array and expands accordingly when the balloon expands, and the RF electrodes are aligned with the holes in the flexible protecting net.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794
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