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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koon (US Patent No 20230165630) herein known as Koon R1 in view of Koon (US Patent No 20240407730) herein known as Koon R2.
Regarding claim 1, Koon R1 teaches a medical system (medical system 100), comprising: a sheath including an elongate body having a proximal portion, a distal portion (see the sheath 106 containing an elongate body with a proximal and distal portion in fig 1), and a lumen therebetween (sheath 106 contains a lumen 138, [0045]); one or more sheath electrodes located on the distal portion (see electrodes 140-146 which are found on the distal end of the sheath, [0046]); a handle attached to the proximal portion (see the proximal hub or handle 120, [0044]), the handle having a first connector capable of electrically coupling to a control system (see in which the hub or handle 120 acts as the connection interface connecting to the RF control generator 102, [0044]) and a second connector coaxial with the lumen (see in which the lumen contains a coaxial electrical conductor 124 which connects the hub member 120 to the distal end of the shaft 116, [0044], thereby equating to a second connector); a dilator including an elongate body having a proximal portion and a distal portion (see the dilator 608 seen in fig 7 containing a proximal and distal end); one or more dilator electrodes located on the distal portion (see distal electrode 640 found on the dilator 608); and a dilator connector electrically coupled to the one or more dilator electrodes (see in which the dilator side wall 650 which acts as a connector contains a wire 648 for connecting to the distal electrodes 640, [0058]); the second connector being configured to mechanically and electrically couple with the dilator connector (see in which the coaxial electrical conductor 124 is electrically and mechanically connectable to the distal end electrodes 640 of the dilator, [0060]).
Koon R1 does not explicitly teach wherein the second connector includes a retaining track having at least one electrical contact.
However, the analogous dilator medical system taught by Koon R2 does teach a second connector (see the sliding electrical connection system 800 seen as the analogous second connector, [0079]) includes a retaining track having at least one electrical contact (in which the electrical connection 800 contains a spring 806 and bush 808 system that retains connection within a socket of the connection member, [0079], thereby teaching a retaining track, in which there is a conductive element 807 extending from the brush 808 to maintain electrical contact [0079]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical system taught by Koon R1, to contain the retaining track and second electrically conductive connection characteristics taught by Koon R2 in order to connect the conductive members of the distal end of the device with that of the energy source of the proximal end, while maintaining electrical connection and limiting the excessive direction or movement of the connecting members, as taught by Koon R2, [0079].
Regarding claim 2, Koon R1 teaches the system of claim 1, wherein the sheath lumen is configured to receive the dilator (see in which the sheath member 606 receives the dilator member 608, fig 7).
Regarding claim 3, the combination teaches the system of claim 2, wherein the dilator includes a dilator hub, and the dilator connector is integral with the dilator hub (see from Koon R2, in which the dilator contains a proximal hub 412 which acts as a connection interface to the rest of the medical system, [0070]).
Regarding claim 4, the combination teaches the system of claim 1, wherein the retaining track is resilient and includes an oval shape body having a width greater than a height (from Koon R2, see in which the brush element 808 which acts as the retaining track includes a beveled end 810, and there by definition contains a shape that has a width that may be greater than the height, [0079]).
Regarding claim 5, the combination teaches the system of claim 4, wherein the resilient retaining track includes a first line of symmetry and a second line of symmetry, and the at least one electrical contact is intersected by the first line of symmetry (from Koon R2, see from fig 7A in which the retaining elements 806 and 808 contain two lines of symmetry and the electrical contact is intersected by the first line).
Regarding claim 6, the combination teaches the system of claim 5, wherein the at least one electrical contract includes a conductive coating (from Koon R2, the conductive element 807 contains a conductive surface element 802, [0079]).
Regarding claim 7, the combination teaches the system of claim 1, wherein the second connector includes a hemostatic valve, a cap, and a cover (see from Koon R2, in which the hub element of the dilator contains a hemostatic valve 232 with cap and cover components, [0067]).
Regarding claim 8, the combination teaches the system of claim 7, wherein the cap includes a retaining track guide (see from Koon R2, in which the insulated housing 804 of the connection element contains a brush slot seen as the analogous retaining track guide, [0079]).
Regarding claim 9, Koon R1 teaches the system of claim 1, wherein electrical connection is made between the one or more dilator electrodes and the control system when the dilator connector is received by the second connector (see in which the dilator side wall 650 which acts as a connector contains a wire 648 for connecting the control system to the distal electrodes 640, [0058]).
Regarding claim 10, Koon R1 teaches the system of claim 1, wherein the dilator distal portion is tapered (see distal tapered portion of the dilator 608, fig 7).
Regarding claim 11, Koon R1 teaches the system of claim 1, wherein the dilator connector includes a cylindrical body having an outer surface (see in which the outer surface 650 of the dilator connector 608 has a cylindrical shape, fig 7), and one or more electrical contacts positioned on the outer surface (see in which the electrode contact 640 is positioned on the outer surface 650, fig 7).
Regarding claim 12, Koon R1 teaches the system of claim 1, wherein the dilator connector is configured to self-align with the second connector (see fig 3, which depicts the coaxial electrical conductor which aligns the second connection point with that of the dilator 608), and wherein the dilator connector is configured to mechanically couple with the second connector in order to maintain the dilator in a desired rotational orientation relative to the sheath (see in which the coaxial electrical conductor 124 is electrically and mechanically connectable such that the distal end electrodes 640 of the dilator are adhered in the desired position, [0060]).
Regarding claim 13, Koon R1 teaches the system of claim 1, wherein the dilator connector includes a distal protrusion (see in which the dilator 608 contains a distal protrusion electrode 622, [0060]).
Regarding claim 14, the combination teaches the system of claim 1, further comprising a display for displaying one or more anatomical images, parameters, and positioning information (from Koon R2, display 92 for mapping parameters, [0053]).
Regarding claim 15, Koon R1 teaches the system of claim 1, wherein the one or more sheath electrodes includes four sheath electrodes (see sheath electrodes 140, 142, 144, 146, [0046], resulting in four sheath electrodes) and the one or more dilator electrodes includes two electrodes (see the dilator electrode 640 and 622, [0060] resulting in two electrodes).
Regarding claim 16, Koon R1 teaches a medical system (medical system 100), comprising: a sheath including an elongate body having a proximal portion, a distal portion (see the sheath 106 containing an elongate body with a proximal and distal portion in fig 1), and a lumen therebetween (sheath 106 contains a lumen 138, [0045]); one or more sheath electrodes located on the distal portion (see electrodes 140-146 which are found on the distal end of the sheath, [0046]); a handle attached to the proximal portion (see the proximal hub or handle 120, [0044]), the handle having a first connector capable of electrically coupling to a control system (see in which the hub or handle 120 acts as the connection interface connecting to the RF control generator 102, [0044]) and a second connector coaxial with the lumen (see in which the lumen contains a coaxial electrical conductor 124 which connects the hub member 120 to the distal end of the shaft 116, [0044], thereby equating to a second connector); a dilator including an elongate body having a proximal portion and a distal portion (see the dilator 608 seen in fig 7 containing a proximal and distal end); one or more dilator electrodes located on the distal portion (see distal electrode 640 found on the dilator 608); one or more dilator electrodes located on the distal portion (see distal electrode 640 found on the dilator 608); and a dilator connector electrically coupled to the one or more dilator electrodes (see in which the dilator side wall 650 which acts as a connector contains a wire 648 for connecting to the distal electrodes 640, [0058]); and wherein electrical connection is made between the one or more dilator electrodes and the control system when the dilator connector is received by the second connector (see in which the coaxial electrical conductor 124 is electrically and mechanically connectable to the distal end electrodes 640 of the dilator, [0060]).
Koon R1 does not explicitly teach wherein the second connector includes a retaining track having at least one electrical contact.
However, the analogous dilator medical system taught by Koon R2 does teach a second connector (see the sliding electrical connection system 800 seen as the analogous second connector, [0079]) includes a retaining track having at least one electrical contact (in which the electrical connection 800 contains a spring 806 and bush 808 system that retains connection within a socket of the connection member, [0079], thereby teaching a retaining track, in which there is a conductive element 807 extending from the brush 808 to maintain electrical contact [0079]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical system taught by Koon R1, to contain the retaining track and second electrically conductive connection characteristics taught by Koon R2 in order to connect the conductive members of the distal end of the device with that of the energy source of the proximal end, while maintaining electrical connection and limiting the excessive direction or movement of the connecting members, as taught by Koon R2, [0079].
Regarding claim 17, the combination teaches the system of claim 16, wherein the resilient retaining track includes an oval shape body having a width greater than a height (from Koon R2, see in which the brush element 808 which acts as the retaining track includes a beveled end 810, and there by definition contains a shape that has a width that may be greater than the height, [0079]).
Regarding claim 18, the combination teaches the system of claim 17, wherein the resilient retaining track includes at least one electrical contact (from Koon R2, there is a conductive element 807 extending from the brush 808 to maintain electrical contact [0079]).
Regarding claim 19, the combination teaches the system of claim 18, wherein the at least one electrical contact includes a conductive coating (from Koon R2, the conductive element 807 contains a conductive surface element 802, [0079]).
Regarding claim 20, Koon R1 teaches a medical system(medical system 100), comprising: a sheath including an elongate body having a proximal portion, a distal portion (see the sheath 106 containing an elongate body with a proximal and distal portion in fig 1), and a lumen therebetween (sheath 106 contains a lumen 138, [0045]); one or more sheath electrodes located on the distal portion (see electrodes 140-146 which are found on the distal end of the sheath, [0046]); a handle attached to the proximal portion (see the proximal hub or handle 120, [0044]), the handle having a first connector capable of electrically coupling to a control system (see in which the hub or handle 120 acts as the connection interface connecting to the RF control generator 102, [0044]) and a second connector coaxial with the lumen (see in which the lumen contains a coaxial electrical conductor 124 which connects the hub member 120 to the distal end of the shaft 116, [0044], thereby equating to a second connector); a dilator including an elongate body having a proximal portion and a distal portion (see the dilator 608 seen in fig 7 containing a proximal and distal end); one or more dilator electrodes located on the distal portion (see distal electrode 640 found on the dilator 608); and a dilator connector electrically coupled to the one or more dilator electrodes (see in which the dilator side wall 650 which acts as a connector contains a wire 648 for connecting to the distal electrodes 640, [0058]); the second connector being configured to mechanically and electrically couple with the dilator connector (see in which the coaxial electrical conductor 124 is electrically and mechanically connectable to the distal end electrodes 640 of the dilator, [0060]).
Koon R1 does not explicitly teach wherein the second connector includes a retaining track having at least one electrical contact, nor does it teach a display for displaying one or more anatomical images, parameters, and positioning information.
However, the analogous dilator medical system taught by Koon R2 does teach a second connector (see the sliding electrical connection system 800 seen as the analogous second connector, [0079]) includes a retaining track having at least one electrical contact (in which the electrical connection 800 contains a spring 806 and bush 808 system that retains connection within a socket of the connection member, [0079], thereby teaching a retaining track, in which there is a conductive element 807 extending from the brush 808 to maintain electrical contact [0079]). Koon R2 also discloses a display for displaying one or more anatomical images, parameters, and positioning information (display 92 for mapping parameters, [0053]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the medical system taught by Koon R1, to contain the retaining track and second electrically conductive connection characteristics taught by Koon R2 in order to connect the conductive members of the distal end of the device with that of the energy source of the proximal end, while maintaining electrical connection and limiting the excessive direction or movement of the connecting members, as taught by Koon R2, [0079]. Furthermore, it would have been obvious for one skilled in the art to combine the medical system taught by Koon R1 to contain the parameter display taught by Koon R2 in order to allow for visualization and real time operator control during treatment, as taught by Koon R2, [0053].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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