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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/16/2024 and 08/28/2024 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 7 and 9-11 are rejected under 35 U.S.C 102(a)(1) as being anticipated by Buesseler et al (US20160276739A1) herein referred to as “Buesseler”.
Regarding claim 1, Buesseler teaches: An electrode assembly (See FIG 2 where 12 is seen as the electrode assembly) comprising: an electrode body (See FIG 2 and [0060] where 48A, 48B, and 48C are seen as the electrode bodies) comprising a top surface and a bottom surface, (See annotated FIG 2 below) the electrode body being configured to deliver ablative energy to tissue through at least the top surface; ([0060] the electrode body delivers ablative energy) a coil disposed near the bottom surface, (See annotated FIG 2 where the position sensor which is seen as the coil [0065] is located near the bottom surface) the coil configured to generate a voltage when subject to a magnetic field; ([0057] the position sensor which is seen as a coil outputs a voltage when placed in magnetic field) and a member disposed near the coil and comprising a high-magnetic-permeability material ([0066] the coil contains a core which is seen as the member, which is constructed of high permeability material).
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Regarding claim 2, Buesseler teaches: The electrode assembly of claim 1, the member being disposed between the coil and the electrode body, (See annotated FIG 2 above where the member which is seen as the core within 26 is between the coil and electrode) the member being attached to the bottom surface of the electrode body (See annotated FIG 2 above).
Regarding claim 7, Buesseler teaches: The electrode assembly of claim 1, the electrode body further comprising a lumen extending therethrough, (See annotated FIG 2 above) the lumen configured to receive a spine of an end effector ([0058] and FIG 2, where the fluid tube which is seen as a spine passes through the lumen of the electrode 48C).
Regarding claim 9, Buesseler teaches: The electrode assembly of claim 1, the coil comprising a flexible circuit ([0058]).
Regarding claim 10, Buesseler teaches: The electrode assembly of claim 1, wherein the high-magnetic-permeability material comprises a Mu-metal ([0084] the core can be made of Mu metal).
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 8 is rejected under U.S.C 103 as being unpatentable over Buesseler in view of Govari et al (US20220193370A1) herein referred to as “Govari”.
Regarding claim 8, Buesseler discloses: The electrode assembly of claim 1, however, Leo does not disclose: the coil comprising a single axis sensor (SAS)
Govari discloses: the coil comprising a single axis sensor (SAS) ([0050] the magnetic coil sensor may be a Single-Axis Sensor (SAS)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coil as disclosed in Buesseler to include it comprising a single axis sensor as disclosed in Govari. The motivation being that this estimates the shape of the expandable distal end based on the orientation which can decrease tissue damage (Govari [0052]).
Claim 11 is rejected under U.S.C 103 as being unpatentable over Buesseler in view of Claude et al (US12642583B2) herein referred to as “Claude”.
Regarding claim 11, Buesseler discloses: The electrode assembly of claim 1, however, Buesseler does not explicitly disclose: further comprising a conductive polymer material disposed along an outer surface of the electrode body.
Claude discloses: a conductive polymer material disposed along an outer surface of the electrode body ([col 5: lines 1-5] the electrode is covered with dielectric materials which can be polymeric based [col 7: line 4]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Buesseler to include a conductive polymer material on the outer surface of the electrode as disclosed in Claude. The motivation being that this increases the impedance (Claude [col 5: lines 1-5]).
Claims 12, 13, and 18-20 are rejected under U.S.C 103 as being unpatentable over Govari in view of Buesseler.
Regarding claim 12, Govari discloses: A medical device ([Abstract] the entire system is seen as the medical device) comprising: a shaft extending along a longitudinal axis; (See FIG 2B where the distal portion 52 is seen as the shaft which extends along the longitudinal axis 58) a plurality of spines disposed at a distal end of the shaft, (See FIG 2B where the flexible strips 55 is seen as the spines which are located at the distal end of the shaft) the plurality of spines configured to bow radially outward from the longitudinal axis ([0054] the flexible strips 55, which are seen as the spines bow radially from the longitudinal axis) and to transition between an expanded configuration and a collapsed configuration; (See FIG 2A showing a collapsed configuration and 2B showing an expanded configuration) a plurality of electrode assemblies attached to the plurality of spines, ([0045] multiple electrodes disposed on the plurality of flexible strips 55, which is seen as the spines) however, Govari does not explicitly disclose: each electrode assembly of the plurality of electrode assemblies comprising: an electrode body comprising a top surface and a bottom surface, the electrode body being configured to deliver ablative energy to tissue through at least the top surface; a coil disposed near the bottom surface, the coil configured to generate a voltage when subject to a magnetic field; and a member disposed near the coil and comprising a high-magnetic-permeability material.
Buesseler discloses: comprising a flexible shaft ([0008] the medical device can have a flexible shaft) and each electrode assembly of the plurality of electrode assemblies comprising: an electrode body (See FIG 2 and [0060] where 48A, 48B, and 48C are seen as the electrode bodies) comprising a top surface and a bottom surface, (See annotated FIG 2 below) the electrode body being configured to deliver ablative energy to tissue through at least the top surface; ([0060] the electrode body delivers ablative energy) a coil disposed near the bottom surface, (See annotated FIG 2 where the position sensor which is seen as the coil [0065] is located near the bottom surface) the coil configured to generate a voltage when subject to a magnetic field; ([0057] the position sensor which is seen as a coil outputs a voltage when placed in magnetic field) and a member disposed near the coil and comprising a high-magnetic-permeability material ([0066] the coil contains a core which is seen as the member, which is constructed of high permeability material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft and the electrodes of the medical device as disclosed in Govari to include the features of the electrode and shaft as disclosed in Buesseler. The motivation being replacing one known element, the electrode of Govari with another known element, the electrode with Buesseler with the predictable result of making the electrode deliver ablative energy through the use ablative energy.
Regarding claim 13, Govari discloses: The medical device of claim 12, however, Govari does not explicitly disclose: the member being disposed between the coil and the electrode body, the member being attached to the bottom surface of the electrode body.
Buesseler discloses: the member being disposed between the coil and the electrode body; (See annotated FIG 2 above) the member being attached to the bottom surface of the electrode body (See annotated FIG 2 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as disclosed in Govari to include a member between the coil and the electrode body as disclosed in Buesseler. The motivation being having this member increases the magnetic flux passing through the coil (Buesseler [0066]).
Regarding claim 18, Govari discloses: The medical device of claim 12, however, Govari does not explicitly disclose: the electrode body further comprising a lumen extending therethrough, the lumen configured to receive a spine of an end effector.
Buesseler discloses: the electrode body further comprising a lumen extending therethrough, (See annotated FIG 2 above) the lumen configured to receive a spine of an end effector ([0058] and FIG 2, where the fluid tube which is seen as a spine passes through the lumen of the electrode 48C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as disclosed in Govari to include a lumen through the electrode body as disclosed in Buesseler. The motivation being this allows for the magnetic fields to be concentrated (Buesseler [0011]).
Regarding claim 19, Govari discloses: The medical device of claim 12, however, Govari does not explicitly disclose: the coil comprising a flexible circuit.
Buesseler discloses: the coil comprising a flexible circuit ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Govari to dispose it on a flexible circuit as disclosed in Buesseler. The motivation being this allows for the assembly to conform to different configurations (Buesseler [0070]).
Regarding claim 20, Govari discloses: The medical device of claim 12, however, Govari does not explicitly disclose: wherein the high-magnetic-permeability material comprises a Mu-metal.
Buesseler discloses: wherein the high-magnetic-permeability material comprises a Mu-metal ([0084] the core can be made of Mu metal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Govari to include Mu-metal as disclosed in Buesseler. The motivation being that Mu metals have a higher magnetic permeability which allows for the magnetic field lines to travel through with higher permeability (Buesseler [0072]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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