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
Acknowledgment is made to the amendment received 7/9/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Govari and Bencini and claim 12 was rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Olson and Bencini. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Karamanoglu in view of Sauer and Kassab and claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Sauer and Kassab.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 6-8, 10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Karamanoglu et al., US 20130030496, herein referred to as “Karamanoglu”, in view of Sauer et al., US 10806511, herein referred to as “Sauer”, further in view of Kassab et al., US 20170164867, herein referred to as “Kassab”.
Regarding claim 1, Karamanoglu discloses a catheter (Figures 6A-B) comprising: an elongated deflectable element extending along a longitudinal axis from a proximal end to a distal end and defining a catheter lumen therethrough (Figures 6A-B: catheter 152 and [0067]: “the nerve stimulation lead 66 may be advanced through the delivery catheter 152”), the elongated deflectable element being navigable to a location of interest within an organ and configured to receive a medical instrument through the catheter lumen for use in administering treatment in the location of interest ([0067]: “once an acceptable implant location has been identified, the nerve stimulation lead 66 may be advanced through the delivery catheter 152 until the lead distal end 68 reaches the catheter distal tip 158… Catheter 152 is shown partially withdrawn over lead 66 to expose the distal electrodes 70 of lead 66.”); a position electrode attached to the elongated deflectable element proximate the distal end and configured for impedance-based position tracking of the distal end to navigate the distal end to the location of interest (Figures 6A-B: proximal electrodes 170 and [0066] and Figure 5). Karamanoglu does not explicitly disclose a catheter comprising a covering at least partially enclosing the position electrode, the covering comprising a plurality of apertures positioned over the position electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures, the conductive surface and an outer surface of the covering being non-planar, the position electrode curving only part way around the catheter lumen of the elongated deflectable element.
However, Sauer teaches a catheter (Figure 23: ablation catheter 10) comprising a covering at least partially enclosing the position electrode (Figure 23: insulation 22 over metal 21), the covering comprising a plurality of apertures positioned over the position electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures (Figure 23: holes 22a), the conductive surface and an outer surface of the covering being non-planar (Figures 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that it comprises a covering at least partially enclosing the position electrode, the covering comprising a plurality of apertures positioned over the position electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures, the conductive surface and an outer surface of the covering being non-planar as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Further, Kassab teaches a catheter (Figure 4) with the position electrode curving only part way around the catheter lumen of the elongated deflectable element (Figure 4: detection electrode 122 curves only partway around the catheter lumen of device 100).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that the position electrode curves only part way around the catheter lumen of the elongated deflectable element as taught by Kassab so that the size of the electrodes ensures that the catheter is flexible (Kassab [0092]).
Regarding claim 4, Karamanoglu in view of Sauer and Kassab teaches the catheter according to claim 1, and Sauer further discloses a catheter with the covering comprising a non-conductive polymer material (Figure 23 and Col. 9, lines 50-52 wherein polyurethane is a non-conductive polymer) and the conductive surface of the position electrode being disposed a distance below an outer surface of the covering (Figure 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so the covering comprises a non-conductive polymer material and the conductive surface of the position electrode is disposed a distance below an outer surface of the covering as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Regarding claim 6, Karamanoglu in view of Sauer and Kassab teaches the catheter according to claim 1, and Sauer further discloses a catheter with the plurality of apertures comprising a plurality of circular apertures (Figure 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so the plurality of apertures comprises a plurality of circular apertures as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Regarding claim 7, Karamanoglu in view of Sauer and Kassab teaches the catheter according to claim 1, but does not explicitly disclose a catheter with the plurality of apertures comprising a plurality of polygonal apertures.
However, it would have been an obvious matter of design choice to make the different portions of the plurality of apertures of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 8, Karamanoglu in view of Sauer and Kassab teaches the catheter according to claim 1, and Karamanoglu further discloses a catheter further comprising an end effector disposed at the distal end of the elongated deflectable element (Figures 6A-B), wherein the position electrode comprises a first position electrode disposed at a proximate end of the end effector (Figures 6A-B: proximal electrodes 170), the catheter further comprising: a second position electrode disposed at a distal end of the end effector (Figures 6A-B: distal electrodes 160).
Regarding claim 10, Karamanoglu in view of Sauer and Kassab teaches the catheter according to claim 1, but does not explicitly disclose a catheter the plurality of apertures comprising a plurality of elongated slits, each elongated slit of the plurality of elongated slits extending from near a first end of the position electrode to near a second end of the position electrode.
However, it would have been an obvious matter of design choice to make the different portions of the plurality of apertures of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 21, Karamanoglu in view of Sauer and Kassab discloses the catheter according to claim 1, and Sauer further teaches a medical system, the plurality of apertures comprising three or more apertures positioned over the positioned electrode in a pattern (Figure 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that the plurality of apertures comprises three or more apertures positioned over the positioned electrode in a pattern as taught as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Karamanoglu in view of Sauer and Kassab, further in view of Tegg, US 20180110440, herein referred to as “Tegg”.
Regarding claim 2, Karamanoglu in view of Sauer and Kassab teaches the catheter according to claim 1, but does not explicitly disclose a catheter further comprising a magnetic position sensor attached to the elongated deflectable element proximate the distal end.
However, Tegg teaches a catheter (Figure 2A) further comprising a magnetic position sensor attached to the elongated deflectable element proximate the distal end Figure 2A: magnetic position sensor 116).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that it has a magnetic position sensor attached to the elongated deflectable element proximate the distal end as taught by Tegg to determine a rotation of the medical device (Tegg [0006]).
Regarding claim 3, Karamanoglu in view of Sauer, Kassab, and Tegg discloses the catheter according to claim 2, and Tegg further teaches a catheter (Figure 2A) with the magnetic position sensor (Figure 2A: magnetic position sensor 116) extending entirely around an outer perimeter of the position electrode (Figure 2A: magnetic position sensor 116 is adjacent to ring electrode 114-2, so it extends entirely around the distal-facing outer perimeter of the electrode).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that the magnetic position sensor extends entirely around an outer perimeter of the position electrode as taught by Tegg so that the magnetic position sensor and the electrode are positioned in a known spatial relationship with respect to one another (Tegg [0041]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Karamanoglu in view of Sauer and Kassab, further in view of Greifeneder, US 20200015885, herein referred to as “Greifeneder”.
Regarding claim 5, Karamanoglu in view of Sauer and Kassab discloses the catheter according to claim 1, but does not explicitly disclose a catheter further comprising a conductive polymer coating disposed in each aperture of the plurality of apertures.
However, Greifeneder discloses a catheter (Figure 1) further comprising a conductive polymer coating disposed on each electrode ([0047]: “a metal may be used for the electrode which is covered by a conductive polymer coating”). In combination with Sauer, this would mean that there is a conductive polymer coating disposed in each aperture of the plurality of apertures since each electrode of Sauer is disposed in each aperture of the plurality of apertures.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that there is a conductive polymer coating disposed on each electrode as taught by Greifeneder to ensure that the part of the catheter that comes into contact with the patient is biocompatible (Greifeneder [0047]).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable Karamanoglu in view of Sauer and Kassab, further in view of Werneth et al., US 20150223757, herein referred to as “Werneth”.
Regarding claim 9, Karamanoglu in view of Sauer and Kassab discloses the catheter according to claim 8, but does not explicitly disclose a catheter further comprising a first magnetic position sensor disposed at the proximal end of the end effector; and a second magnetic position sensor disposed at the distal end of the end effector.
However, Werneth teaches a catheter (Figure 6: catheter 100) further comprising a first magnetic position sensor disposed at the proximal end of the end effector (Figure 1A: electrode 141 at the proximal end of expandable assembly 130 and [0105]: “In some embodiments, diagnostic catheter 100 can deliver therapy, such as an ablation therapy delivered to tissue, in addition to its function as a diagnostic catheter, e.g. providing electrical, anatomical and/or device mapping information. In some embodiments, one or more electrodes 141 each comprise one or more coils, such as when the one or more coils are configured to create one or more magnetic fields.”); and a second magnetic position sensor disposed at the distal end of the end effector (Figure 1A: electrode 141 at the distal end of expandable assembly 130 and [0105]: “In some embodiments, diagnostic catheter 100 can deliver therapy, such as an ablation therapy delivered to tissue, in addition to its function as a diagnostic catheter, e.g. providing electrical, anatomical and/or device mapping information. In some embodiments, one or more electrodes 141 each comprise one or more coils, such as when the one or more coils are configured to create one or more magnetic fields.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that there is a first magnetic position sensor disposed at the proximal end of the end effector and a second magnetic position sensor disposed at the distal end of the end effector as taught by Werneth so that the system can provide output including distance measurements; anatomical maps; device position maps; electrical maps; dipole maps; and combinations of these (Werneth [0145]).
Regarding claim 11, Karamanoglu in view of Sauer and Kassab discloses the catheter according to claim 1, but does not explicitly disclose a catheter with the covering comprising a conductive polymer material.
However, Werneth teaches a catheter (Figure 6: catheter 100) with the covering comprising a conductive polymer material ([0028]: “The plurality of dipole mapping electrodes can comprise a coating selected from the group consisting of: a metal oxide coating; a conductive polymer coating; and combinations of these”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the catheter of Karamanoglu so that the covering comprises a conductive polymer material as taught by Werneth so that the coating is at least one of electrochemically catalytic or directly reactive with at least one of blood, blood plasma or saline solutions (Werneth [0028]).
Claims 12, 14-15, 17-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Sauer and Kassab.
Regarding claim 12, Werneth teaches a medical system (Figure 6) comprising: a handle (Figure 6: handle 110); and a probe attached to the handle (Figure 6: catheter 500) comprising: an elongated deflectable element extending along a longitudinal axis from a proximal end to a distal end and defining a catheter lumen therethrough (Figure 6: shaft 520), the elongated deflectable element being navigable to a location of interest within an organ and configured to receive a medical instrument through the catheter lumen for use in administering treatment in the location of interest (Figure 6: contact array 530 and [0142]: “Control 515 can be constructed and arranged to allow an operator to perform an action selected from the group consisting of: steer shaft 520; radially expand and/or contract array 530;”); a position electrode attached to the elongated deflectable element proximate the distal end (Figure 6: electrode 541 and [0142]: “Diagnostic catheter 500 can include one or more electrodes 541 and one or more ultrasound transducers 551, having the same or similar functionality as electrodes 141 and ultrasound transducers 151 described in reference to FIG. 1A hereabove”) and configured for impedance-based position tracking of the distal end to navigate the distal end to the location of interest ([0008] and [0037] and [0136]); and a covering at least partially enclosing the position electrode ([0028]: “The plurality of dipole mapping electrodes can comprise a coating selected from the group consisting of: a metal oxide coating; a conductive polymer coating; and combinations of these. ”), the covering comprising a conductive polymer ([0028]: “The plurality of dipole mapping electrodes can comprise a coating selected from the group consisting of: a metal oxide coating; a conductive polymer coating; and combinations of these. ”); and a plurality of external electrodes (Figure 6: body surface electrodes 820), the plurality of external electrodes configured to receive a current output by the position electrode ([0145]: “ In some embodiments, SPU 300 can send and/or record signals to and/or from accessory device 800 and/or body surface electrodes 820, such as when body surface electrodes 820 are positioned on the chest and abdomen of patient P as shown. For example, SPU 300 can record electric signals such as ultrasonic reflections from any or all of the ultrasound transducers of system 10 and can record current and/or voltage signals from any or all of the electrodes of system 10.”). Werneth does not explicitly disclose a medical system comprising a plurality of apertures positioned over the position electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures, the conductive surface and an outer surface of the covering being non-planar, and the position electrode extending only part way around a circumference of the elongated deflectable element.
However, Sauer teaches a medical system (Figure 23: ablation catheter 10) comprising a covering at least partially enclosing the position electrode (Figure 23: insulation 22 over metal 21), the covering comprising a plurality of apertures positioned over the position electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures (Figure 23: holes 22a), the conductive surface and an outer surface of the covering being non-planar (Figures 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical system of Werneth so that it comprises a covering at least partially enclosing the position electrode, the covering comprising a plurality of apertures positioned over the position electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures, the conductive surface and an outer surface of the covering being non-planar as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Further, Kassab teaches a medical system (Figure 4) with the position electrode curving only part way around the catheter lumen of the elongated deflectable element (Figure 4: detection electrode 122 curves only partway around the catheter lumen of device 100).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical system of Werneth so that the position electrode curves only part way around the catheter lumen of the elongated deflectable element as taught by Kassab so that the size of the electrodes ensures that the catheter is flexible (Kassab [0092]).
Regarding claim 14, Werneth in view of Sauer and Kassab teaches the medical system according to claim 1, and Sauer further discloses a catheter with the covering comprising a non-conductive polymer material (Figure 23 and Col. 9, lines 50-52 wherein polyurethane is a non-conductive polymer) and the conductive surface of the position electrode being disposed a distance below an outer surface of the covering (Figure 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical system of Werneth so the covering comprises a non-conductive polymer material and the conductive surface of the position electrode is disposed a distance below an outer surface of the covering as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Regarding claim 15, Werneth in view of Sauer and Kassab discloses the medical system according to claim 12, and Werneth further discloses a medical system, the probe further comprising a magnetic position sensor ([0091] and [0105]) attached to the elongated deflectable element proximate the distal end (Figure 1A: electrodes 141 are proximate the distal end and [0105]: “In some embodiments, diagnostic catheter 100 can deliver therapy, such as an ablation therapy delivered to tissue, in addition to its function as a diagnostic catheter, e.g. providing electrical, anatomical and/or device mapping information. In some embodiments, one or more electrodes 141 each comprise one or more coils, such as when the one or more coils are configured to create one or more magnetic fields.”).
Regarding claim 17, Werneth in view of Sauer and Kassab discloses the medical system according to claim 15, and Werneth further discloses a medical system further comprising a magnetic field generator configured to generate a magnetic field (Figure 1A: electrodes 141 and [0105]: “In some embodiments, one or more electrodes 141 each comprise one or more coils, such as when the one or more coils are configured to create one or more magnetic fields.”), the magnetic position sensor configured to output a signal based at least in part on the magnetic field ([0008] and [0105]: “In some embodiments, diagnostic catheter 100 can deliver therapy, such as an ablation therapy delivered to tissue, in addition to its function as a diagnostic catheter, e.g. providing electrical, anatomical and/or device mapping information. In some embodiments, one or more electrodes 141 each comprise one or more coils, such as when the one or more coils are configured to create one or more magnetic fields.”).
Regarding claim 18, Werneth in view of Sauer and Kassab discloses the medical system according to claim 17, and Werneth further discloses a medical system, the signal being a first signal and the medical system further comprising a controller (Figure 6: signal processing unit 300) configured to: receive the first signal from the magnetic position sensor ([0139]: “System 10 includes signal processing unit (SPU) 300, such as a computer system used to receive signals to produce electrical, anatomical and/or device mapping information. ” and [0105]: “In some embodiments, diagnostic catheter 100 can deliver therapy, such as an ablation therapy delivered to tissue, in addition to its function as a diagnostic catheter, e.g. providing electrical, anatomical and/or device mapping information. In some embodiments, one or more electrodes 141 each comprise one or more coils, such as when the one or more coils are configured to create one or more magnetic fields.”); receive a second signal from the plurality of external electrodes ([0145]: “SPU 300 can send and/or record signals to and/or from accessory device 800 and/or body surface electrodes 820”); and determine, based at least in part on the first signal or the second signal ([0146]), a position of the probe ([0145]).
Regarding claim 19, Werneth in view of Sauer and Kassab discloses the medical system according to claim 18, and Werneth further discloses a medical system, the controller being further configured to determine, based at least in part on the first signal or the second signal ([0139]: “System 10 includes signal processing unit (SPU) 300, such as a computer system used to receive signals to produce electrical, anatomical and/or device mapping information. ”), an orientation of the probe ([0095]: “Additionally, the location of ablation catheter 200 or other inserted devices can be displayed, such as their position relative to tissue or diagnostic catheter 100. ” and [0114]).
Regarding claim 20, Werneth in view of Sauer and Kassab discloses the medical system according to claim 12, and Werneth further discloses a medical system, the handle and the probe comprising a lumen extending therethrough configured to permit a catheter device to be inserted therethrough (Figure 6 and [0013]: “The diagnostic catheter comprises an elongate shaft comprising a distal end where the diagnostic catheter shaft is configured to slidingly receive the distal portion of the ablation catheter shaft”).
Regarding claim 22, Werneth in view of Sauer and Kassab discloses the medical system according to claim 12, and Sauer further teaches a medical system, the plurality of apertures comprising three or more apertures positioned over the positioned electrode in a pattern (Figure 23).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical system of Werneth so that the plurality of apertures comprise three or more apertures positioned over the positioned electrode in a pattern as taught as taught by Sauer to allow for venting of the electrode (Sauer Col. 9, lines 46-49).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Sauer and Kassab, further in view of Tegg.
Regarding claim 16, Werneth in view of Sauer and Kassab discloses the medical system according to claim 15, but does not explicitly disclose a medical system with the magnetic position sensor disposed between the elongated deflectable element and the position electrode.
However, Tegg discloses a medical system (Figure 2A) with the magnetic position sensor ((Figure 2A: magnetic position sensor 116) disposed between the elongated deflectable element and the position electrode (Figure 2A: magnetic position sensor 116 is between flexible tip assembly 130 and ring electrode 114-2).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical system of Werneth so that the magnetic position sensor is disposed between the elongated deflectable element and the position electrode as taught by Tegg so that the magnetic position sensor and the electrode are positioned in a known spatial relationship with respect to one another (Tegg [0041]).
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.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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