DETAILED ACTION
Applicant's amendments and remarks, filed 8/11/26, are fully acknowledged by the Examiner. Currently, claims 1-19 are pending with claims 1-3 and 5 amended. Applicant's amendments to claims 2, 3, and 5 have overcome the previously filed 35 USC 112(b) rejection. The following is a complete response to the 8/11/26 communication.
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 (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.
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.
Claim(s) 1-6 and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honour
(US 8,147,486) in view of Indravudh (US 2010/0331940), in further view of Atalar (US 2008/0119919), in further view of Kim (US 2019/0275320).
Regarding claim 1, Honour teaches a catheterization system, comprising:
a catheter comprising an elongated catheter body having proximal and distal ends (catheter 38 with shaft 46 having proximal and distal ends), and a
distal-end assembly at the distal end of the catheter body (distal end 42), the distal-end assembly comprising:
a flexible substrate comprising a circumferentially extending section generally wrapping around a circumferential region of the distal end of the catheter body (col. 7, lines 54-63), and a distal tip section generally wrapping around a distal tip of the catheter body (Col. 17, lines 19-20);
one or more electrodes formed by first electrical conductors on the flexible substrate configured to exchange electrical signals with the proximal end of the catheter body (Col. 8, lines 11-17),
Honour is silent regarding a magnetic resonance imaging (MRI) system and a control console coupled to the MRI system and the catheter.
However, Atalar teaches a console coupled to an MRI and a catheter system as in at least Fig. 3 and par. [0097].It would have been obvious to one of ordinary skill in the art to modify Honour with the MRI system and console, as in Atalar, to determine the location of the catheter during treatment.
Honour is silent regarding one or more filters.
However, Indravudh teaches one or more filters printed on the flexible substrate adjacent at least one of the one or more electrodes, the one or more filters configured to filter signals in a predefined frequency range caused by the MRI system from the electrical signals exchanged between the adjacent one of the at least one of the one or more electrodes and the proximal end of the catheter body (par. [0047]-[0048] filter to filter high frequencies caused by MRI as in par. [0029]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.Honour is silent regarding one or more filters formed by second electrical conductors printed on the flexible substrate and shaped to form at least one of an inductor, a capacitor, or a resistor.However, Kim teaches inductor, capacitor, and resistor elements formed by second electrical conductors (par. [0064] printed conductive components made with silver micro-flake ink).
It would have been obvious to one of ordinary skill in the art that the components of Honour would be made with second electrical conductors, as known materials for use in a printable circuit.
Regarding claim 2, Honour is silent, but Indravudh teaches wherein at least one of the one or more filters is shaped to form at least one of an inductor and a capacitor (par. [0042]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
Regarding claim 3, Honour is silent, but Indravudh teaches wherein at least one of the one or more filters is shaped to form an inductor and a capacitor that are connected in parallel (par. [0042]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
Regarding claim 4, Honour teaches wherein the flexible substrate comprises a flexible printed circuit board (col. 7, lines 4-17).
Regarding claim 5, Honour teaches ablation signals to be applied to a patient tissue (col. 7, lines 31-46).
Indravudh teaches the one or more filters printed on the flexible substrate as in the rejection to claim 1.
Regarding claim 6, Honour is silent, but Indravudh teaches the predefined frequency range comprises 58-70MHz (par. [0021]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
Regarding claim 10, Honour is not explicit wherein each of the one or more electrodes is associated with at least one respective one of the one or more filters.
However, Indravudh teaches electrodes associated with the filters (par. [0029] electrodes 75 associated with filters 230).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
Regarding claim 11, Honour teaches wherein the one or more electrodes comprises at least one ablation electrode (col. 10, lines 55-60).
Regarding claim 12, Honour teaches ablation signals (col. 10, lines 55-60), but is silent regarding the filter.
However, Indravudh teaches wherein the one or more filters comprises at least one first filter printed on the flexible substrate adjacent the at least one ablation electrode and configured to pass signals from the proximal end of the catheter body to the at least one electrode (par. [0029] electrodes 75 associated with filters 230).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
Regarding claim 13, Honour is silent, but Indravudh teaches the inductor and the capacitor are connected in parallel (par. [0042]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
Claim(s) 7-9, 14-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Honour in view of Indravudh, in further view of Atalar, in view of Kim, in further view of Wang (US 5,462,545).
Regarding claim 7, Honour is not explicit wherein the one or more electrodes comprises one or more microelectrodes printed on either or both of the circumferentially extending section or distal tip section of the flexible substrate.
However, Wang teaches a conductive layer of microelectrodes (Col. 8, lines 28-30; Fig. 3D, electrically conductive panels 80).
It would have been obvious to one of ordinary skill in the art to modify Honour with the microelectrodes of Wang, to concentrate the delivered energy (col. 8, lines 18-24).
Regarding claim 8, Honour is not explicit regarding wherein the one or more electrodes comprise one or more ring electrodes.
However, Wang portrays the electrode structure being around the circumference of the catheter, the circumference being a ring shape (Fig. 2a, electrodes 29).
It would have been obvious to one of ordinary skill in the art to modify Honour with the microelectrodes of Wang, to concentrate the delivered energy (col. 8, lines 18-24).
Regarding claim 9, Honour is silent wherein the one or more electrodes comprises one or more ring electrodes, and one or more microelectrodes printed on either or both of the circumferentially extending section or distal tip section of the flexible substrate.
However, Wang portrays the electrode structure being around the circumference of the catheter, the circumference being a ring shape (Fig. 2a, electrodes 29), and a conductive layer of microelectrodes (Col. 8, lines 28-30; Fig. 3D, electrically conductive panels 80).
It would have been obvious to one of ordinary skill in the art to modify Honour with the microelectrodes of Wang, to concentrate the delivered energy (col. 8, lines 18-24).
Regarding claim 14, Honour is not explicit wherein the one or more electrodes further comprises at least one micro-electrode configured to sense electrical signals from tissue.
However, Wang teaches a conductive layer of microelectrodes (Col. 8, lines 28-30; Fig. 3D, electrically conductive panels 80).
It would have been obvious to one of ordinary skill in the art to modify Honour with the microelectrodes of Wang, to concentrate the delivered energy (col. 8, lines 18-24).
Regarding claim 15, Honour is silent regarding wherein the one or more filters comprises at least one second filter printed on the flexible substrate adjacent the at least one micro-electrode and configured to pass electrical signals from tissue to the control console.
However, Atalar teaches multiple filters (67 and 68 as in par. [0081]) adjacent electrodes and passing electrical signals from tissue to the control console (par. [0081]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the MRI system and console, as in Atalar, to determine the location of the catheter during treatment.
Regarding claim 16, Honour is silent regarding the filters.
However, Atalar teaches wherein the at least one second filter comprises a resistor connected to a respective one of the micro-electrodes and a respective trace (par. [0065]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the MRI system and console, as in Atalar, to determine the location of the catheter during treatment.
Regarding claim 17, Honour is silent regarding the filters.
However, Indravudh teaches wherein the one or more filters comprises:
one or more first filters printed on the flexible substrate adjacent at least one of the one or more ablation electrodes (230 and 75 adjacent), the one or more first filters configured to pass ablation signals from the proximal end of the catheter body to the one or more ablation electrodes (par. [0029] electrodes 75 associated with filters 230).
It would have been obvious to one of ordinary skill in the art to modify Honour with the filter of Indravudh, as a filter to filter the MRI signal for accurate measurements.
However, Atalar teaches multiple filters (67 and 68 as in par. [0081]) adjacent electrodes and passing electrical signals from tissue to the control console (par. [0081]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the MRI system and console, as in Atalar, to determine the location of the catheter during treatment.
Regarding claim 19, Honour teaches wherein the distal end of the catheter defines an internal member comprising:
a proximal base at a proximal end of the internal member (proximal spacer 72);
a distal tip support at a distal end of the internal member (distal spacer 72), the distal tip support defining an opening through which irrigation fluid can pass (openings 80); and one or more longitudinally extending supports connecting the proximal base to the distal tip support (tubes through lumens 80 as in col. 15, lines 4-17), the one or more longitudinally extending supports being spaced apart from each other to define a fluid path between the proximal base and the distal tip support (lumens and tubes spaced from each other as in at least Fig. 12), the circumferentially extending section of the flexible substrate being connected to the proximal base (Fig. 8), and the distal tip section of the flexible substrate being connected to the distal tip support (Fig. 8).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honour (US 8,147,486) in view of Indravudh (US 2010/0331940), in further view of Atalar (US 2008/0119919), in further view of Cheung (US 2016/0113712)
Regarding claim 18, Honour is not explicit wherein the flexible substrate further comprises a
plurality of irrigation openings in either or both of the circumferentially extending section or the distal tip section.
However, Cheung teaches a catheter with a plurality of irrigation openings at the distal tip section (irrigation ports 126 as in Fig. 2 and par. [0091]).
It would have been obvious to one of ordinary skill in the art to modify Honour with the irrigation ports of Cheung at the distal tip section, allowing for irrigating a treatment area during treatment.
Response to Arguments
Applicant’s arguments, see the remarks, filed 8/11/26, with respect to the rejection(s) of claim(s) 1-19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kim as a secondary reference.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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