DETAILED ACTION
Applicant's amendments and remarks, filed 5/8/26, are fully acknowledged by the Examiner. Currently, claims 1-10 are pending with claim 1 amended. The following is a complete response to the 5/8/26 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 § 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.
Claims 1-10 are 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 1 recites the limitation "the electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-4 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 5,545,161).
Regarding claim 1, Imran teaches an ablation catheter, comprising: a catheter, a handle and a connector which are connected in sequence (catheter 13, handle 51, and connector 39 as in at least Fig. 1), electrodes comprise a distal electrode and at least one ring electrode (electrodes 41 and 42), wherein a plurality of electrodes are provided in sequence at a distal end of the catheter (electrodes 41 and 42), each of the electrodes has a corresponding electrode lead (43 and 44 as in Fig. 2), which passes through the catheter and the handle and is connected to the connector (connected to connector 39 as in col. 4 lines 9-16); wherein the catheter comprises an insulated inner catheter (inner catheter 12), the electrodes are provided on the insulated inner catheter (41 and 42 provided on 12), an insulated outer catheter is provided between the plurality of electrodes (outer electrode 51), electrode leads of the plurality of electrodes are respectively provided between the insulated inner catheter and the insulated outer catheter (43 and 44 provided between catheters as in Fig. 2), the ring electrode is tightly pressed against the surface of the insulated inner catheter (ring tightly pressed against 12).Imran is not explicit in Fig. 1, but teaches an embodiment in at least Fig. 19 with an insulated outer catheter is provided between the distal electrode and the ring electrode (insulated catheter as 341 as in Fig. 19), and the insulated outer catheter is affixed to the surface of the insulated inner catheter (341 against analogous inner catheter 312), the electrode leads for both the distal electrode and the ring electrode are positioned between the insulated inner catheter and the insulated outer catheter (leads sandwiched between the catheters in channels), with the electrode leads of different electrodes being staggered from each other, thereby preventing short circuits (Fig. 19).It would have been obvious to one of ordinary skill in the art to modify Fig. 1 of Imran with the outer catheter of Fig. 19 of Imran, allowing for insulating as in col. 14, lines 44-61.
Regarding claim 2, Imran teaches wherein the distances between adjacent electrodes are equal (spacing between 41 and 42).
Regarding claim 3, Imran teaches wherein an adhesive is provided between the electrode leads and the insulated inner catheter, to fix the positions of the electrode leads (as in at least col. 3 lines 45-52).
Regarding claim 4, Imran teaches wherein first insulated sleeves are sleeved on each of the electrode leads, and the first insulated sleeves are provided between the insulated inner catheter and the insulated outer catheter (col. 7, lines 10-17).
Regarding claim 7, Imran teaches wherein the plurality of electrodes can simultaneously or individually release ablation energy, to perform ablation operations (col. 19, lines 21-24).
Regarding claim 8, Imran teaches wherein the electrodes are distal electrodes or ring electrodes (41 and 42 are distal electrodes), each distal electrode is provided at a distal end of the catheter (41 and 42 at a distal end of the catheter).
Regarding claim 9, Imran teaches wherein a flexible section is provided at the distal end of the catheter (flexible portion with braid 21), the flexible section can bend relative to the catheter (flexible portion bends relative to the catheter), and the electrodes are provided at a catheter body portion where the flexible section is located (as in at least Fig. 2).
Regarding claim 10, Imran teaches wherein the flexible section comprises an annular body formed by winding memory metal (nitinol as in col. 9 lines 23-28), and a flexible material is coated on the annular body in an annular shape or a spiral shape, or the flexible material is sleeved on the annular body directly (as in at least Figs. 11-12 nitinol sleeved in the annular body).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Roop (US 2005/0267462).
Regarding claim 5, Imran is not explicit wherein a sensor is provided in a catheter body at the distal end of the catheter, the sensor is a pressure sensor and/or a magnetic positioning sensor, and leads of the pressure sensor and/or the magnetic positioning sensor are provided between the insulated inner catheter and the insulated outer catheter.
However, Roop teaches a sensor is provided in a catheter body at the distal end of the catheter (pressure sensor at the end of catheter as in par. [0047]), the sensor is a pressure sensor and/or a magnetic positioning sensor, and leads of the pressure sensor and/or the magnetic positioning sensor are provided between the insulated inner catheter and the insulated outer catheter (lead 60 between catheters).
It would have been obvious to one of ordinary skill in the art to modify Imran in view of Roop with a pressure sensor, allowing for detecting parameters to be able to adjust treatment accordingly.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Roop, in further view of Vanney (US 2005/0267463).
Regarding claim 6, Imran is silent, but Vanney teaches wherein a second insulated sleeves are sleeved on leads of the pressure sensor and/or the magnetic positioning sensor (52' insulated as in par. [0074]), and the second insulated sleeve is provided between the insulated inner catheter and the insulated outer catheter (Figs. 9-11).
It would have been obvious to one of ordinary skill in the art to modify the combination such that leads are insulated, to prevent unwanted shorting.
Response to Arguments
Applicant's arguments filed 5/8/26 have been fully considered but they are not persuasive. Applicant argues that Imran does not teach the insulation with an outer catheter, the leads staggered, or prevent short circuits. However, Imran teaches an outer catheter as in at least Fig. 19, leads staggered in different channels as in Fig. 12 to prevent the leads from contacting.
Conclusion
THIS ACTION IS MADE FINAL. 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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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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