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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/14/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 1/14/2026.
Applicant' s amendments to the claims are sufficient to overcome the 35 USC § 112(b) rejections set forth in the previous office action.
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 claim 12 was rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Olson. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Govari and Bencini and claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Olson and Bencini.
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 1-2, 4, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Olson et al., US 20190021620, herein referred to as “Olson”, further in view of Govari et al., US 20070016007, herein referred to as “Govari”, further in view of Bencini et al., US 20150282859, herein referred to as “Bencini”.
Regarding claim 1, Olson discloses a catheter (Figure 2) comprising: an elongated deflectable element extending along a longitudinal axis from a proximal end to a distal end (Figure 2: shaft 24 of catheter 18); a position electrode ([0080]: “In some embodiments, the partially-masked electrodes 42 can perform location or position sensing functions related to cardiac mapping.”) attached to the elongated deflectable element proximate the distal end (Figure 3: partially-masked electrodes 42 are proximate distal end 50); and a covering (Figures 5-9: surface coating 56) at least partially enclosing the position electrode (Figures 5-9: surface coating 56 partially encloses electrodes 42 and [0065]: “An aperture is formed in the insulated surface coating 56 to create a contoured opening 58 that exposes or reveals a small area of the conductive band 54.”), the covering comprising a plurality of apertures positioned over the position electrode (Figures 5-9: openings 58 and [0066]: “Moreover, although a single opening 58 is shown per partially-masked electrode 42, it will be understood that each partially-masked electrode 42 may include more than one opening 58 (e.g., 2, 3, 4, or more) without departing from the scope of the disclosure.”) such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures (Figure 5: opening 58 and [0066]: “Moreover, although a single opening 58 is shown per partially-masked electrode 42, it will be understood that each partially-masked electrode 42 may include more than one opening 58 (e.g., 2, 3, 4, or more) without departing from the scope of the disclosure.”), the conductive surface and an outer surface of the covering being non-planar (Figure 8: void 62 and Figure 9: surface coating 56 and conductive band 54 are non-planar). Olson does not explicitly disclose a catheter comprising a position electrode configured for impedance-based position tracking, or a catheter comprising a position electrode extending only part way around a circumference of the elongated deflectable element.
However, Govari teaches a catheter (Figures 1-3: catheter 20) comprising a position electrode configured for impedance-based position tracking (Figure 5).
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 Olson so that the position electrode is configured for impedance-based position tracking as taught by Govari so that the position of the catheter is determined accurately and with the low cost of impedance-based sensing (Govari [0008]).
Further, Bencini teaches a catheter (Figure 1) comprising an electrode (Figure 12A and Figure 12D: region 1230 and [0075]: “FIG. 12D illustrates an example cut-away view of a two-layer trace/electrode structure in which conductor layers 1220 and 1222 are disposed on both sides of the flexible sheet 1205 and selectively insulated with insulator layers 1225 and 1228 that is not applied in a region 1230 to form an electrode.”) extending only part way around a circumference of the elongated deflectable element (Figure 12D: the electrode is a sheet and thus only contacts flexible sheet 1205 on the top and bottom of the sheet, not on the sides, thus the electrode extends only part way around a circumference or perimeter of the deflectable element.). In combination with Olson, the electrode is a position 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 Olson so that the position electrode extends only part way around a circumference of the elongated deflectable element as taught by Bencini so that the signal paths may be more protected and less prone to break or become electrically open (Bencini [0075]).
Regarding claim 2, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Govari further teaches a catheter further comprising a magnetic position sensor attached to the elongated deflectable element proximate the distal end (Figure 3: magnetic field sensor 22 is proximate the distal end of catheter 20).
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 Olson so that it has a magnetic position sensor attached to the elongated deflectable element proximate the distal end as taught by Govari so that the position sensing of the system benefits from both the high accuracy of magnetic position sensing and the low cost of impedance-based sensing ([0008]).
Regarding claim 4, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Olson further teaches a catheter, the covering (Figures 5-9: surface coating 56) comprising a non-conductive polymer material ([0064]: “The surface coating 56 may be formed of a material with high dielectric properties that can be applied in a very thin layer. Exemplary surface coatings may include thin coatings of polyester, polyamides, polyimides, and blends of polyurethane and polyimides. In one embodiment, for example only and without limitation, surface coating 56 may be Parylene (e.g., Parylene C, Parylene N).”) and the conductive surface of the position electrode being disposed a distance below an outer surface of the covering (Figure 8: void 62 and Figure 9: surface coating 56 and conductive band 54 are non-planar).
Regarding claim 6, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Olson further teaches a catheter, the plurality of apertures comprising a plurality of circular apertures ([0066]: “it will be understood that opening 58 may have other shapes, with or without rounded edges or corners, without departing from the scope of the disclosure, including, for example only and without limitation, a circle, an ellipse, a diamond, a rectangle, a hexagon, a square, a pentagon, an irregular polygon, a triangle. ”).
Regarding claim 7, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Olson further teaches a catheter, the plurality of apertures comprising a plurality of polygonal apertures ([0066]: “it will be understood that opening 58 may have other shapes, with or without rounded edges or corners, without departing from the scope of the disclosure, including, for example only and without limitation, a circle, an ellipse, a diamond, a rectangle, a hexagon, a square, a pentagon, an irregular polygon, a triangle. ”).
Regarding claim 8, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Olson further teaches a catheter further comprising an end effector disposed at the distal end of the elongated deflectable element (Figures 2-3: basket electrode assembly 30 is disposed at the distal end of shaft 24 of catheter 18), wherein the position electrode comprises a first position electrode disposed at a proximate end of the end effector (Figure 3: any electrode on one spline 36 near proximal end 32), the catheter further comprising: a second position electrode disposed at a distal end of the end effector (Figure 3: any electrode on the same spline 36 near distal end 34).
Regarding claim 10, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Olson further teaches a catheter, the plurality of apertures (Figures 5-9: opening 58) comprising a plurality of elongated slits ([0066]: “Although the contoured opening 58 is shown as having an oval shape, it will be understood that opening 58 may have other shapes, with or without rounded edges or corners, without departing from the scope of the disclosure, including, for example only and without limitation, a circle, an ellipse, a diamond, a rectangle, a hexagon, a square, a pentagon, an irregular polygon, a triangle.”, 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 (Figure 3: each electrode on a single spline 36 has an opening 58, which is an elongated slit, and these opening 58 extend from near a first end of the most proximal electrode to near a second end of the most distal electrode on that spline 36).
Regarding claim 21, Olson in view of Govari and Bencini teaches the catheter according to claim 1, and Olson further teaches a catheter, the plurality of apertures comprising three or more apertures positioned over the positioned electrode in a pattern ([0066]: “Moreover, although a single opening 58 is shown per partially-masked electrode 42, it will be understood that each partially-masked electrode 42 may include more than one opening 58 (e.g., 2, 3, 4, or more) without departing from the scope of the disclosure.”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Olson in view of Govari and Bencini, further in view of Tegg, US 20180110440, herein referred to as “Tegg”.
Regarding claim 3, Olson in view of Govari and Bencini discloses the catheter according to claim 2, but does not explicitly disclose a catheter with the magnetic position sensor disposed at least partially around an outer perimeter of the position electrode.
However, Tegg 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 Olson 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 is 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 Olson in view of Govari and Bencini, further in view of Greifeneder, US 20200015885, herein referred to as “Greifeneder”.
Regarding claim 5, Olson in view of Govari and Bencini discloses the catheter according to claim 2, including Olson disclosing an electrode disposed in each aperture of the plurality of apertures (Figures 5-9: partially-masked electrodes 42 and opening 58), 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 Olson, this would mean that there is a conductive polymer coating disposed in each aperture of the plurality of apertures since each electrode of Olson 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 Olson 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 over Olson in view of Govari and Bencini, further in view of Werneth et al., US 20150223757, herein referred to as “Werneth”.
Regarding claim 9, Olson in view of Govari and Bencini 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 Olson 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, Olson in view of Govari and Bencini discloses the catheter according to claim 8, 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 Olson 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 12-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Olson and Bencini.
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: shaft 120) comprising: an elongated deflectable element extending along a longitudinal axis from a proximal end to a distal end (Figures 1A-B: catheter 200 and expandable assembly 130); a position electrode attached to the elongated deflectable element proximate the distal end (Figure 1A: electrode 141) and configured for impedance-based position tracking ([0008] and [0037]); 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, Olson teaches a medical system (Figure 2) comprising a plurality of apertures positioned over the electrode such that a portion of a conductive surface of the position is exposed through each aperture of the plurality of apertures (Figures 5-9: openings 58 and [0066]: “Moreover, although a single opening 58 is shown per partially-masked electrode 42, it will be understood that each partially-masked electrode 42 may include more than one opening 58 (e.g., 2, 3, 4, or more) without departing from the scope of the disclosure.”), the conductive surface and an outer surface of the covering being non-planar (Figure 8: void 62 and Figure 9: surface coating 56 and conductive band 54 are non-planar).
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 there are a plurality of apertures positioned over the electrode such that a portion of a conductive surface of the position electrode is exposed through each aperture of the plurality of apertures as taught by Olson so that the electrode is isolated from the conductive path through the blood pool (Olson [0070]).
Further, Bencini teaches a medical system (Figure 1) comprising an electrode (Figure 12A and Figure 12D: region 1230 and [0075]: “FIG. 12D illustrates an example cut-away view of a two-layer trace/electrode structure in which conductor layers 1220 and 1222 are disposed on both sides of the flexible sheet 1205 and selectively insulated with insulator layers 1225 and 1228 that is not applied in a region 1230 to form an electrode.”) extending only part way around a circumference of the elongated deflectable element (Figure 12D: the electrode is a sheet and thus only contacts flexible sheet 1205 on the top and bottom of the sheet, not on the sides, thus the electrode extends only part way around a circumference or perimeter of the deflectable element.). In combination with Werneth, the electrode is a position 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 medical system of Werneth so that the position electrode extends only part way around a circumference of the elongated deflectable element as taught by Bencini so that the signal paths may be more protected and less prone to break or become electrically open (Bencini [0075]).
Regarding claim 14, Werneth in view of Olson and Bencini discloses the medical system according to claim 12, and Olson further discloses a medical system with the conductive surface of the position electrode being disposed a distance below an outer surface of the covering (Figure 9: conductive band 54 is below the outer surface of surface coating 56 and they are non-planar).
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 conductive surface of the position electrode being disposed a distance below an outer surface of the covering as taught by Olson so that the electrode is isolated from the conductive path through the blood pool (Olson [0070]).
Regarding claim 15, Werneth in view of Olson and Bencini discloses the medical system according to claim 12, and Wilson 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 Olson and Bencini discloses the medical system according to claim 15, and Wilson 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 Olson and Bencini discloses the medical system according to claim 17, and Wilson 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 Olson and Bencini discloses the medical system according to claim 18, and Wilson 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 Olson and Bencini discloses the medical system according to claim 12, and Wilson 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 Olson and Bencini discloses the medical system according to claim 12, and Olson further teaches a medical system, the plurality of apertures comprising three or more apertures positioned over the positioned electrode in a pattern ([0066]: “Moreover, although a single opening 58 is shown per partially-masked electrode 42, it will be understood that each partially-masked electrode 42 may include more than one opening 58 (e.g., 2, 3, 4, or more) without departing from the scope of the disclosure.”).
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 by Olson since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Werneth in view of Olson, Bencini, and Tegg.
Regarding claim 16, Werneth in view of Olson and Bencini 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
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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