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 .
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.
Status of the Claims
The current office action is made responsive to claims filed 03/03/2026.
Acknowledgement is made to the amendment of claim 27.
Acknowledgement is made to the cancellation of claims 1-26, 28-33, and 36-41.
Acknowledgement is made to the newly added claims 43-46.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 27, 34-35, and 42-46 are pending. A complete action on the merits appears below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 27, 34-35, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Pontis (US 20090171344 A1) in view of Harlev (US 20200069365 A1), Welsh (US 20190200886 A1), and Hyde (US 20170000369 A1).
Regarding claim 27, Pontis teaches a system (Fig. 1; system 10) comprising:
a patch (Fig. 1; dispersive return pad 50), the patch having an electrode (Fig. 6A; contacting segment 94) and a dispersion element (Fig. 6A; return electrode 120), wherein the dispersion element is configured to receive current from an ablation electrode and to act as a grounding pad ([0043]- [0044]); wherein the electrode and the dispersion element are located on a first side of each of said respective patches ([0039], [0048]); and
wherein said first side of each of said respective patches is adapted for placement on a human body ([0035]).
However, Pontis fails to teach the patch as being a plurality of patches.
While Pontis does not explicitly teach the patch as being plural patches, there is no evidence that more than one patches makes a meaningful difference to the function of the device compared to the currently taught patch and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)).
Pontis further teaches the system as including an electrosurgical instrument including an active electrode ([0076]).
However, Pontis further fails to teach the system comprising: an ablation catheter having at least one ablation electrode.
Harlev teaches a system having an ablation electrode for delivering electrical energy to tissue and receiving the electrical energy at a plurality of return electrodes on the skin of the patient (Abstract, [0015]).
Harlev further teaches the ablation electrode as being delivered to the target site by any means envisaged by a skilled person, such as a catheter ([0066]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an ablation catheter to deliver an electrode for providing electrical energy to tissue to a treatment site, as is taught by Harlev, into the system which delivers electrical energy to patient tissue by an electrosurgical instrument as is taught by Pontis, to produce the predictable result of delivering an electrode which provides electrical energy to a target site, as is taught by Harlev, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Pontis further fails to teach each patch of the plurality of patches having a 3D position sensor; wherein said plurality of patches comprises at least six patches that are arranged as an array substantially surrounding an ablation site; wherein each patch is adapted such that the electrode and the dispersion element of each of said respective patches is positioned one of the following positions: high anterior, low anterior, high posterior, low posterior, left lateral, or right lateral; wherein the array approximates an octahedron or square bipyramid defined by the and comprises at least one of the plurality of patches located at the each of the following positions: high anterior, low anterior, high posterior, low posterior, left lateral, and right lateral positions.
Welsh teaches a system having a catheter having an electrode array ([0058]) and a plurality of plurality of electrodes for contacting patient skin ([0065]- [0066]) for use in guiding said ablation catheters within the body of a patient ([0204]).
Welsh further teaches the plurality of electrodes which act as sensors in the localization system are taught as being positioned on opposite sides of the ribs, one on the lower back, one on the upper chest, one on the upper back and one on the lower abdomen so as to define a coordinate system for localization ([0065], [0068]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the plurality of electrodes as being positioned on opposite side of the ribs, on the upper and lower positions of the abdomen, and on the upper and lower positions of the back, as is taught by Welsh, into the system having a plurality of electrodes for contacting patient tissue as is taught by Pontis as currently modified, to produce the predictable result of providing positioning of the ablation catheter within the body of the patient, as is taught by Welsh, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Pontis further fails to teach the 3D position sensor as being located on the opposite side the patch from the electrode and the dispersion element.
Hyde teaches a device which contains at least one electrode for collecting measurements (Abstract, [0023]) and a corresponding position sensor ([0029]).
Hyde further teaches the electrode being located on a surface-contacting portion of the device and the corresponding position sensor as being on an opposite, non-surface contacting portion of the glove ([0029]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position sensor as being on a side opposite an electrode, as is taught by Hyde, into the system having an electrode and a position sensor as is taught by Pontis as currently modified, to produce the predictable result of providing position sensor data relevant to the location of the electrode, as is taught by Hyde, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 34, Pontis further teaches the system of claim 27, wherein each dispersion element of each patch is electrically isolated from other elements of the respective patch ([0046]).
Regarding claim 35, Welsh teaches the system of claim 27, further comprising one or more processors configured to determine the position coordinates of each of the plurality of patches and to determine an ablation vector from the at least one ablation electrode to each of the plurality of patches ([0262], [0274], [0276]- [0278]).
Regarding claim 42, Pontis further teaches the system of claim 27, wherein the electrode and the dispersion element are electrically isolated from each other ([0046]).
Regarding claim 43, Harlev further teaches the system of claim 27, wherein the first side of each of said respective patches comprises an adhesive material ([0067] teaches the return electrodes as being releasably secured to the skin, such as by an adhesive surface).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the return electrodes as including an adhesive surface, as is taught by Harlev, into the return electrodes for contacting patient tissue as is taught by Pontis as currently modified, to produce the predictable result of releasably securing the return electrodes to the skin of the patient, as is taught by Harlev, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Dodd (US 20070055225 A1) in view Cailler (US 20160331263 A1), Welsh (US 20190200886 A1), and Hyde (US 20170000369 A1).
Regarding claim 44, Dodd teaches a system ([0013]) comprising:
at least six patches arranged as an array substantially surrounding an ablation site ([0022], [0027]); and
an ablation catheter having at least one ablation electrode ([0027]); wherein the at least six patches comprise:
(i) a first patch located at a first position of a human body ([0027]), said first patch comprising a first side comprising a dispersion element ([0027]) and a second side, said first side of said first patch further comprising an adhesive element suitable for adhering said first patch to human skin ([0022]) such that the dispersion element of said first patch is positioned at the first position;
(ii) a second patch located at a second position of a human body ([0027]), said second patch comprising a first side comprising a dispersion element ([0027]) and a second side, said first side of said second patch further comprising an adhesive element suitable for adhering said second patch to human skin ([0022]) such that the dispersion element of said second patch is positioned at the second position;
(iii) a third patch located at a position of a human body ([0027]), said third patch comprising a first side comprising a dispersion element ([0027]) and a second side, said first side of said third patch further comprising an adhesive element suitable for adhering said third patch to human skin ([0022]) such that the dispersion element of said third patch is positioned at the third position;
(iv) a fourth patch located at a position of a human body ([0027]), said fourth patch comprising a first side comprising a dispersion element ([0027]) and a second side, said first side of said fourth patch further comprising an adhesive element suitable for adhering said fourth patch to human skin ([0022]) such that the dispersion element of said fourth patch is positioned at the fourth position;
(v) a fifth patch located at a position of a human body ([0027]), said fifth patch comprising a first side comprising a dispersion element ([0027]) and a second side, said first side of said fifth patch further comprising an adhesive element suitable for adhering said fifth patch to human skin ([0022]) such that the dispersion element of said fifth patch is positioned at the fifth position; and
(vi) a sixth patch located at a position of a human body ([0027]), said sixth patch comprising a first side comprising a dispersion element ([0027]) and a second side, said first side of said sixth patch further comprising an adhesive element suitable for adhering said sixth patch to human skin ([0022]) such that the dispersion element of said sixth patch is positioned at the sixth position;
wherein each respective dispersion element is configured to receive current from an ablation electrode and to act as a grounding pad ([0027]).
Dodd further teaches a system for use with ablation methods (Abstract).
However, Dodd fails to teach the first side of the patches, which adheres to human skin, as comprising an electrode.
Cailler teaches a customizable electrode system having a plurality of electrode patches for contact with the surface of a patient’s body (Abstract, [0035]). These electrode patches being adjustable so as to take into account tools which may be used during the procedure, such as interventional or sensing tools, and to take into account patient gender and morphology requirements ([0062]).
Cailler further teaches the patches as containing a variety of pre-cuts which may be utilized with a variety of interventional or sensing tools, these pre-cuts including navigation pre-cuts and ground patch pre-cuts so as to allow body surface ECG signal acquisition to be performed quickly and easily, and also to be combined quickly and easily with non-invasive mapping and navigation tools, ablation methods, etc. ([0035], [0046], [0052], [0055], [0062]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of a variety of electrodes and sensing elements, such as at least one ECG electrode, at least one ground patch, and at least one navigation sensing element onto the same patch of a plurality of patches of an electrode system, as is taught by Cailler, into the patches comprising multiple elements, such as at least one electrode and at least one sensor, as is taught by Dodd, to produce the predictable result of utilizing a variety of known interventional and sensing tools in conjunction with ECG signal acquisition, as is taught by Cailler, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Dodd further teaches the invention of a plurality of electrodes for contacting the patient’s skin which is used in an ablation setting as comprising a plurality of sensors to monitor operation conditions of the invention ([0012], [0027]).
However, Dodd further fails to teach the plurality of patches each comprising a 3D position sensor and the array as approximating an octahedron or square bipyramid, wherein the first position of the first patch is a high anterior position, the second position of the second patch is a low anterior position, the third position of the third patch is a high posterior position, the fourth position of the fourth patch is a low posterior position, the fifth position of the fifth patch is a left lateral position, and the sixth position of the sixth patch is a right lateral position.
Welsh teaches a system having a catheter having an electrode array ([0058]) and a plurality of plurality of electrodes for contacting patient skin ([0065]- [0066]) for use in guiding said ablation catheters within the body of a patient ([0204]).
Welsh further teaches the plurality of electrodes which act as sensors in the localization system are taught as being positioned on opposite sides of the ribs, one on the lower back, one on the upper chest, one on the upper back and one on the lower abdomen so as to define a coordinate system for localization ([0065], [0068]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the plurality of electrodes as being positioned on opposite side of the ribs, on the upper and lower positions of the abdomen, and on the upper and lower positions of the back, as is taught by Welsh, into the system having a plurality of electrodes and a plurality of sensors for monitoring conditions of the invention as is taught by Dodd, to produce the predictable result of guiding an ablation catheter within the body of the patient, as is taught by Welsh, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Dodd further fails to teach the second side comprising the 3D position sensor.
Dodd in view of Cailler further teaches the first side, which is the side which adhered to human skin as comprising an electrode. Specifically, Cailler teaches the electrode as being an electrode which receives ECG signals.
Hyde teaches a device which contains at least one electrode for collecting electrocardiogram measurements (Abstract, [0023]) and a corresponding position sensor ([0029]).
Hyde further teaches the electrode being located on a surface-contacting portion of the device and the corresponding position sensor as being on an opposite, non-surface contacting portion of the glove ([0029]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the position sensor as being on a side opposite an electrode, as is taught by Hyde, into the system having an electrode and a position sensor as is taught by Dodd as currently modified, to produce the predictable result of providing position sensor data relevant to the location of the electrode, as is taught by Hyde, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 45, in accordance with the above rejection, Welsh teaches the system of claim 44, wherein each respective dispersion element of the at least six patches is electrically isolated from other elements of the respective patch ([0064] teaches the patch electrodes, and therefore the position sensor of the claim language as being electrically isolated from the rest of the system).
Regarding claim 46, Welsh further teaches the system of claim 44, further comprising one or more processors configured to determine the position coordinates of each of the at least six patches and to determine an ablation vector from the at least one ablation electrode to each of the at least six patches ([0262], [0274], [0276]- [0278]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Gliner/Cailler/Hauck reference are moot in view of the new rejections under the rejections of Pontis/Harlev/Welsh/Hyde and Dodd/Cailler/Welsh/Hyde.
Conclusion
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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