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 .
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.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman et al (US 2012/0172697) (“Urman”) in view of Sterrett et al (US 2017/0112405) (“Sterrett”).
Regarding Claim 1, while Urman teaches an electrode catheter (Abstract, [0020], [0028]-[0029), comprising:
a base material having a thin-film shape (Fig. 4, [0028]-[0029], [0052]-[0054] base material having a thin-film shape / sheet array 60 having a thin flexible sheet shape);
a shape support structure of the base material (Fig. 4, [0028]-[0030] [0052]-[0054], multiple spine 14, [0022] utilizing shape memory material such as Nitinol); and
a plurality of electrodes provided on the base material (Fig. 4, [0028]-[0030] [0052]-[0054] multiple electrodes 60 provided on the base material / sheet array 60), wherein
at least some of the plurality of electrodes are exposed on a front surface (Fig. 4, [0028]-[0030] [0052]-[0054] multiple electrodes 60 provided on the front surface of the base material / sheet array 60, deployed towards a heart wall).
Urman fails to teach at least some of the plurality of electrodes are exposed on a back surface of the base material.
However Sterrett teaches an electrode catheter (Abstract, [0002] electrode mapping catheter) comprising
A flexible tip portions to conform to tissue (Fig. 19D, [0180], [0188]), the flexible tip portion comprising:
A shape support structure ([0180], [0188] carrier arms where [0083] where the structure of the arms is previously noted as shape memory material such as Nitinol);
A plurality of electrodes provided on the shape support structure (Figs. 19A, 19D, [0180], [0188] flexible tip portion comprises a plurality of electrodes 502-1, 502-2…502-16 on the shape support structure / carrier arms 504, 506, 508, and 510); and
at least some of the plurality of electrodes are exposed on a front surface and a back surface of the shape support structure ([0188] where having electrodes on both surfaces enables greater functionality such as both unipolar and bipolar electrogram configurations and tissue contact monitoring).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply electrodes on both sides of the base material of Urman as taught by Sterrett as this provides greater functionality to the electrode mapping catheter by further enabling to identify when it has contacted tissue and to what degree it has contact tissue (Sterrett: [0188]), a fact appreciated by both Urman and Sterrett as both are electrode mapping catheter utilizing shape memory material to deliver an electrode array to target tissue.
Regarding Claim 2, Urman and Sterrett teach the electrode catheter according to claim 1, and Urman teaches wherein the plurality of electrodes are each connected to a conducting wire that extends along the back surface of the base material ([0056]), and Sterrett teaches the plurality of electrodes are each connected to a conducting wire that extends along the same surface of the base material as the electrode (Fig. 19A, [0181]-[0182] shown in the Figure where the conducting wires can be placed along the support structure in several ways).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to alternatively apply the conductive wires of Urman with at least some of the plurality of electrodes each connected to a conducting wire that extends along the front surface of the base material, and a remainder of the plurality of electrodes connected to a conducting wire that extends along the back surface of the base material as Sterrett teaches this as one of many manners of connecting conductive wires to electrodes in mapping catheters. Thus, it is a simple substitution of one form of connecting conductive wires in a mapping catheter (within the base) for another (on the surface of the base) to obtain predictable results of adequately communicated electrical signals.
Regarding Claim 4, Urman and Sterrett teach the electrode catheter according to claim 1, and Urman teaches the catheter comprising:
a plurality of the base materials (See Claim 1 Rejection, Fig. 4, multiple distinct sections of electrode arrays), wherein
the electrode catheter further comprises a shaft that holds a root of each of the plurality of the base materials (Fig. 4, [0022] shaft / catheter body 12 holds the root of each of the electrode arrays); and
a connecting member that connects adjacent ones of the plurality of the base materials (Fig. 4, the wire elements connect adjacent sheet electrode arrays by the wire elements and at the center of the distinct sheet sections), and
the plurality of the base materials are arranged circumferentially around the shaft and are capable of assuming an expanded state and a contracted state (Fig. 4, [0022]-[0024]).
Regarding Claim 5, Urman and Sterrett teach the electrode catheter according to claim 4, and Urman teaches wherein the plurality of electrodes are each connected to a conducting wire that extends along the back surface of the base material ([0056]), and Sterrett teaches the plurality of electrodes are each connected to a conducting wire that extends along the same surface of the base material as the electrode (Fig. 19A, [0181]-[0182] shown in the Figure where the conducting wires can be placed along the support structure in several ways) and the front-side conducting wire and the back-side conducting wire are axially provided on outer surfaces of a root along the root of the base material (Fig 19A, [0183], [0185] shown extending on the root along to contact pads).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to alternatively apply the conductive wires of Urman with at least some of the plurality of electrodes each connected to a conducting wire that extends along the front surface of the base material, and a remainder of the plurality of electrodes connected to a conducting wire that extends along the back surface of the base material as Sterrett teaches this as one of many manners of connecting conductive wires to electrodes in mapping catheters. Thus, it is a simple substitution of one form of connecting conductive wires in a mapping catheter (within the base) for another (on the surface of the base) to obtain predictable results of adequately communicated electrical signals.
Regarding Claim 6, Urman and Sterrett teach the electrode catheter according to claim 5, and Urman teaches wherein
the root of the base material comprises a first surface facing a front side of the base material and a second surface facing a back side of the base material (Fig. 4, the root of the base material is the portion of the electrode sheet array at the center of the expanded multiple electrode sheet arrays),
the front-side conducting wire is provided on the first surface, and
the back-side conducting wire is provided on the second surface (See Claim 5 Rejection, with such a configuration occurring due to the teachings of Sterrett).
Regarding Claim 7, Urman and Sterrett teach the electrode catheter according to claim 1, comprising: 20 or more of the plurality of electrodes (See Claim 1 Rejection, Fig. 4, each electrode array sheet shown including 15 electrodes, indicating a total of 75 electrodes on the front surface).
Regarding Claim 8, while Urman teaches a potential detection device (Abstract, [0020], [0028]-[0029], [0054], [0057] electrical detection device for mapping, [0070] electrical detection information can be electrical potential), comprising:
a base material having a thin-film shape (Fig. 4, [0028]-[0029], [0052]-[0054] base material having a thin-film shape / sheet array 60 having a thin flexible sheet shape);
a shape support structure of the base material (Fig. 4, [0028]-[0030] [0052]-[0054], multiple spine 14, [0022] utilizing shape memory material such as Nitinol); and
a plurality of electrodes provided on the base material (Fig. 4, [0028]-[0030] [0052]-[0054] multiple electrodes 60 provided on the base material / sheet array 60), wherein
at least some of the plurality of electrodes are exposed on a front surface (Fig. 4, [0028]-[0030] [0052]-[0054] multiple electrodes 60 provided on the front surface of the base material / sheet array 60, deployed towards a heart wall).
Urman fails to teach at least some of the plurality of electrodes are exposed on a back surface of the base material.
However Sterrett teaches an electrode catheter (Abstract, [0002] electrode mapping catheter) comprising
A flexible tip portions to conform to tissue (Fig. 19D, [0180], [0188]), the flexible tip portion comprising:
A shape support structure ([0180], [0188] carrier arms where [0083] where the structure of the arms is previously noted as shape memory material such as Nitinol);
A plurality of electrodes provided on the shape support structure (Figs. 19A, 19D, [0180], [0188] flexible tip portion comprises a plurality of electrodes 502-1, 502-2…502-16 on the shape support structure / carrier arms 504, 506, 508, and 510); and
at least some of the plurality of electrodes are exposed on a front surface and a back surface of the shape support structure ([0188] where having electrodes on both surfaces enables greater functionality such as both unipolar and bipolar electrogram configurations and tissue contact monitoring).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply electrodes on both sides of the base material of Urman as taught by Sterrett as this provides greater functionality to the electrode mapping catheter by further enabling to identify when it has contacted tissue and to what degree it has contact tissue (Sterrett: [0188]), a fact appreciated by both Urman and Sterrett as both are electrode mapping catheter utilizing shape memory material to deliver an electrode array to target tissue.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman in view of Sterrett and further in view of Prakash et al (US 2011/0218527) (“Prakash”).
Regarding Claim 3, while Urman and Sterrett teach the electrode catheter according to claim 1, wherein the shape support structure is a shape memory member arranged along a portion of a periphery of the base material (See Claim 1 Rejection, spines 14 of Urman noted as potentially constructed of Nitinol, and the spines are along a periphery of the base material by being arranged along two edges of the separate, distinct sheet sections), their combined efforts fail to teach the shape support structure entirely being arranged along a periphery of the base material.
However Prakash teaches an electrode deploying catheter (Abstract) comprising a distal deployed electrode-based membrane ([0012]) and further teaches a shape support structure deploying the membrane by using shape support structure that can either be arranged along a portion of a periphery of the base material (Fig. 7, [0041] ground plane membrane bounded by wire elements 121 along two edges of distinct sections) or along the entire periphery of the base material (Fig. 8, [0042] wire element 221 encompassing the membrane to create a petal shape).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the electrode-based sheet of Urman as distinct petals with shape support structure along the periphery as taught by Prakash as Prakash teaches that both the design of Urman (Fig. 7 of Prakash) and the petal design (Fig. 8 of Prakash) can accomplish the distributed application of an electrode across tissue. Thus it is a simple substitution of one form of configuring the electrode array for another to obtain predictable results of distributed application of electrodes.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urman in view of Sterrett and further in view of Fang (US 2013/0253504) and further in view of Prakash.
Regarding Claim 9, while Urman teaches a potential detection method (Abstract, [0020], [0028]-[0029], [0054], [0057] electrical detection device for mapping, [0070] electrical detection information can be electrical potential, [0066]-[0071] method steps), comprising:
expanding a plurality of thin-film shaped base materials supported by a shape support structure in a contracted state (Fig. 4, [0028]-[0029], [0052]-[0054] plurality of base materials having a thin-film shape / sheet arrays 60 having a thin flexible sheet shape, supported by multiple spines 14, [0022] utilizing shape memory material such as Nitinol. [0067] the expansion step is outlined);
contacting a front surface of each of some of the plurality of thin-film shaped base materials with a potential detection target surface (Fig. 4, [0028]-[0030] [0052]-[0054] multiple electrodes 60 provided on the base material / sheet array 60, deployed towards a heart wall), Urman fails to teach contacting a back surface of each of a remainder of the plurality of thin-film shaped base materials with the potential detection target surface.
However Sterrett teaches an electrode catheter (Abstract, [0002] electrode mapping catheter) comprising
A flexible tip portions to conform to tissue (Fig. 19D, [0180], [0188]), the flexible tip portion comprising:
A shape support structure ([0180], [0188] carrier arms where [0083] where the structure of the arms is previously noted as shape memory material such as Nitinol);
A plurality of electrodes provided on the shape support structure (Figs. 19A, 19D, [0180], [0188] flexible tip portion comprises a plurality of electrodes 502-1, 502-2…502-16 on the shape support structure / carrier arms 504, 506, 508, and 510); and
at least some of the plurality of electrodes are exposed on a front surface and a back surface of the shape support structure ([0188] where having electrodes on both surfaces enables greater functionality such as both unipolar and bipolar electrogram configurations and tissue contact monitoring)
and further teaches that either the front surface or the back surface of the tip can interface with the target surface for monitoring ([0188]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply electrodes on both sides of the base material of Urman as taught by Sterrett as this provides greater functionality to the electrode mapping catheter by further enabling to identify when it has contacted tissue and to what degree it has contact tissue (Sterrett: [0188]), a fact appreciated by both Urman and Sterrett as both are electrode mapping catheter utilizing shape memory material to deliver an electrode array to target tissue.
Yet their combined efforts fail to teach contacting a back surface of each of a remainder of the plurality of thin-film shaped base materials with the potential detection target surface.
However Fang teaches an electrode mapping catheter (Abstract) that can utilize independent support structures for maneuvering electrodes within the patient ([0010]) and Prakash teaches an electrode deploying catheter (Abstract) comprising a distal deployed electrode-based membrane ([0012]) and further teaches a shape support structure deploying the membrane by using shape support structure that can either be arranged as multiple connected base materials (Fig. 7, [0041] ground plane membrane bounded by wire elements 121 along two edges of distinct sections) or as independent base materials (Fig. 8, [0042] wire element 221 encompassing the membrane to create a petal shape).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the electrode-based sheet of Urman as distinct petals with shape support structure as taught by Prakash can be an alternative to the design of Urman as Prakash teaches that both the design of Urman (Fig. 7 of Prakash) and the petal design (Fig. 8 of Prakash) can accomplish the distributed application of an electrode across tissue. And the reasoning to do this substitution is provided by Fang. Fang outlines flexibility provided by distinct electrode array sections for independent action which would enable a functionality of Sterrett’s front and back electrodes and Prakash teaches a similar design to Urman that would fulfill Urman’s purposes and free the separate arrays to perform the vice versa monitoring of target tissue, i.e. contacting a back surface of each of a remainder of the plurality of thin-film shaped base materials with the potential detection target surface.
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791