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 03/16/2026.
Acknowledgement is made to the amendment of claims 1, 17, and 20.
Claims 1-20 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 1, 9, 11, 15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20180056038 A1) in view of Metzger (US 5117828 A).
Regarding claim 1, Aujla teaches a method of forming a spline for an electrode assembly ([0009]- [0010]) for a catheter system, the method comprising:
providing a structural member (Fig. 11; support member 43) including a first surface and a second surface;
providing a flexible circuit assembly ([0057]) separate from the structural member including a plurality of electrodes (Fig. 5; electrodes 13) and at least one flexible circuit substrate (Fig. 11; non-conductive coverings 44) having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes disposed on the outer surface of the at least one flexible circuit substrate ([0058]);
positioning the flexible circuit assembly relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member ([0058]); and
coupling the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate of the flexible circuit assembly (It should be understood within a broadest reasonable interpretation that all elements of an apparatus are “coupled to” all other elements of that same embodiment, either directly, indirectly, electrically, etc.).
However, Aujla fails to teach the flexible circuit assembly, which is taught as including a plurality of electrodes and at least one flexible circuit substrate, as being formed as an integrated unit.
While Aujla does not specifically teach the flexible circuit assembly as being formed as an integrated unit, Applicant has not disclosed that these components being integral produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(V)(B)).
Metzger teaches a catheter having an elongated body which carries at least one electrode and a plurality of insulative members which the electrodes are formed thereon (Abstract, Fig. 4 & Fig. 8).
Metzger further teaches the electrode as being positioned on the insulating members (Fig. 4) and the electrodes being formed integrally with the insulating members (Fig. 8).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any functional elements, such as those of the flexible circuit assembly limitation as currently taught by Aujla, to be formed as an integral unit, as long as each functional element retains its ability to function in a desired and/or predictable manner. An example of these elements functioning in a predictable manner when formed both integrally and not formed integrally can be seen by the teaching of Metzger which teaches that both the electrode being formed integrally with the insulating member and not being formed integrally function to provide the electrodes of the catheter as contacting patient tissue.
Regarding claim 9, Aujla teaches the method of claim 1, wherein the at least one flexible circuit substrate of the flexible circuit assembly comprises a tubular substrate defining a cavity therein; and wherein positioning the flexible circuit assembly relative to the structural member comprises inserting the structural member in the cavity of the tubular substrate ([0057]).
Regarding claim 11, Aujla teaches the method of claim 1, wherein the structural member is constructed of nitinol ([0049]).
Regarding claim 15, Aujla teaches the method of claim 1, further comprising incorporating the formed spline into a basket electrode assembly ([0048]).
Regarding claim 17, Aujla teaches an electrode assembly (Fig. 1; distal electrode assembly 15) for a catheter system, the electrode assembly having a longitudinal axis, a proximal end, and a distal end, the electrode assembly comprising:
at least one spline (Fig. 1; spine 42) extending from the proximal end to the distal end of the electrode assembly, the at least one spline comprising:
a structural member (Fig. 11; support member 43) extending from the proximal end to the distal end of the electrode assembly, the structural member including a first surface and a second surface; and
a flexible circuit assembly ([0057]) separate from the structural member including a plurality of electrodes and at least one flexible circuit substrate (Fig. 11; non-conductive coverings 44) having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes disposed on the outer surface of the at least one flexible circuit substrate ([0058]),
wherein the flexible circuit assembly is positioned relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member ([0058]), and wherein the at least one flexible circuit substrate is coupled to at least one of the structural member and the at least one flexible circuit substrate (It should be understood within a broadest reasonable interpretation that all elements of an apparatus are “coupled to” all other elements of that same embodiment, either directly, indirectly, electrically, etc.).
However, Aujla fails to teach the flexible circuit assembly, which is taught as including a plurality of electrodes and at least one flexible circuit substrate, as being formed as an integrated unit.
While Aujla does not specifically teach the flexible circuit assembly as being formed as an integrated unit, Applicant has not disclosed that these components being integral produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(V)(B)).
Metzger teaches a catheter having an elongated body which carries at least one electrode and a plurality of insulative members which the electrodes are formed thereon (Abstract, Fig. 4 & Fig. 8).
Metzger further teaches the electrode as being positioned on the insulating members (Fig. 4) and the electrodes being formed integrally with the insulating members (Fig. 8).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any functional elements, such as those of the flexible circuit assembly limitation as currently taught by Aujla, to be formed as an integral unit, as long as each functional element retains its ability to function in a desired and/or predictable manner. An example of these elements functioning in a predictable manner when formed both integrally and not formed integrally can be seen by the teaching of Metzger which teaches that both the electrode being formed integrally with the insulating member and not being formed integrally function to provide the electrodes of the catheter as contacting patient tissue.
Regarding claim 20, Aujla teaches a catheter system ([0036]) comprising:
a flexible catheter shaft (Fig. 1; catheter body 12);
a handle (Fig. 1; handle 16) coupled to a proximal end of the catheter shaft;
an electrode assembly (Fig. 1; distal electrode assembly 15) coupled to a distal end of the flexible catheter shaft and having a longitudinal axis, a proximal end, and a distal end, the electrode assembly comprising at least one spline (Fig. 1; spine 42) extending from the proximal end to the distal end of the electrode assembly, the at least one spline comprising:
a structural member (Fig. 11; support member 43) extending from the proximal end to the distal end of the electrode assembly, the structural member including a first surface and a second surface; and
a flexible circuit assembly ([0057]) separate from the structural member including a plurality of electrodes (Fig. 5; electrodes 13) and at least one flexible circuit substrate (Fig. 11; non-conductive coverings 44) having a contact surface and an outer surface opposite the contact surface, the plurality of electrodes disposed on the outer surface of the at least one flexible circuit substrate ([0058]), wherein the flexible circuit assembly is positioned relative to the structural member such that a first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and a second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member ([0058]), and wherein the at least one flexible circuit substrate is coupled to at least one of the structural member and the at least one flexible circuit substrate (It should be understood within a broadest reasonable interpretation that all elements of an apparatus are “coupled to” all other elements of that same embodiment, either directly, indirectly, electrically, etc.).
However, Aujla fails to teach the flexible circuit assembly, which is taught as including a plurality of electrodes and at least one flexible circuit substrate, as being formed as an integrated unit.
While Aujla does not specifically teach the flexible circuit assembly as being formed as an integrated unit, Applicant has not disclosed that these components being integral produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(V)(B)).
Metzger teaches a catheter having an elongated body which carries at least one electrode and a plurality of insulative members which the electrodes are formed thereon (Abstract, Fig. 4 & Fig. 8).
Metzger further teaches the electrode as being positioned on the insulating members (Fig. 4) and the electrodes being formed integrally with the insulating members (Fig. 8).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any functional elements, such as those of the flexible circuit assembly limitation as currently taught by Aujla, to be formed as an integral unit, as long as each functional element retains its ability to function in a desired and/or predictable manner. An example of these elements functioning in a predictable manner when formed both integrally and not formed integrally can be seen by the teaching of Metzger which teaches that both the electrode being formed integrally with the insulating member and not being formed integrally function to provide the electrodes of the catheter as contacting patient tissue.
Claim 2-4, 6, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20180056038 A1) in view of Metzger (US 5117828 A) further in view of Kawate (US 20080156437 A1).
Regarding claim 2, Aujla teaches the method of claim 1.
However, Aujla fails to teach the method wherein coupling the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate comprises coupling the at least one flexible circuit substrate to the structural member using an adhesive.
Kawate teaches a method for connecting flexible circuit boards (Abstract).
Kawate further teaches the method of connecting the flexible circuit board as being by providing the flexible circuit boards with a thermosetting adhesive and applying heat while the boards are slid together with maintained pressure so as to cure the adhesive and provide connection between the flexible printed circuit boards (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the method of connecting flexible circuit boards, as is taught by Kawate, into the elements for connecting electrodes on either side of a support member as is taught by Aujla, to produce the predictable result of connecting elements, as is taught by Kawate, 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 3, in accordance with the above rejection of claim 2, Kawate further teaches the method of claim 2, wherein coupling the at least one flexible circuit substrate to the structural member comprises coupling the contact surface of the at least one flexible circuit substrate to at least one of the first surface and the second surface of the structural member using the adhesive ([0019]- [0020]).
Regarding claim 4, in accordance with the above rejection of claim 2, Kawate further teaches the method of claim 1, wherein coupling the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate comprises heat sealing the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate ([0019]- [0020]).
Regarding claim 6, in accordance with the above rejection of claim 2, Kawate further teaches the method of claim 5, wherein coupling the first and second flexible circuit substrates at their respective first edges and at their respective second edges comprises coupling the first and second flexible circuit substrates using an adhesive such that the first and second flexible circuit substrates are slidable relative to the structural member ([0019]- [0020]).
Regarding claim 8, in accordance with the above rejection of claim 2, Kawate teaches the method of claim 7, wherein coupling the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate comprises coupling the first flexible circuit substrate to the second flexible circuit substrate using an adhesive ([0019]- [0020]).
Regarding claim 12, in accordance with the above rejection of claim 2, Kawate teaches the method of claim 1, wherein the at least one flexible circuit substrate is a flexible printed circuit (Abstract).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20180056038 A1) in view of Metzger (US 5117828 A) further in view of Tollner (US 20010031942 A1).
Regarding claim 10, Aujla teaches the method of claim 9, wherein positioning the flexible circuit assembly relative to the structural member further comprises providing the tubular substrate such that the first set of electrodes is aligned with the first surface of the structural member and the second set of electrodes is aligned with the second surface of the structural member ([0057]).
However, Aujla fails to teach this providing the tubular substrate as being compressing the tubular substrate.
Tollner teaches an elongate catheter body having an electrode assembly comprising a plurality of electrodes ([0026]- [0028]).
Tollner further teaches the assembly containing the electrodes as being formed by compressing a bent component surrounding the base component so as to secure the electrodes on the body of the catheter ([0036]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the forming of the electrode structure on a catheter body by compressing the component onto the body, as is taught by Toller, into the elongate catheter element containing electrodes as is taught by Aujla, to produce the predictable result of securing an element onto an elongate body, as is taught by Tollner, 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).
Claim 5, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20180056038 A1) in view of Metzger (US 5117828 A).
Regarding claim 5, Aujla teaches the method of claim 1, wherein the at least one flexible circuit substrate includes a first flexible circuit substrate, the first circuit substrates including first and second longitudinal edges (Fig. 11; non-conductive coverings 44);
wherein positioning the flexible circuit assembly relative to the structural member comprises positioning the structural member between the first flexible circuit substrates ([0048]- [0050]); and
wherein coupling the at least one flexible circuit substrate to at least one of the structural member and the at least one flexible circuit substrate comprises coupling the first and second flexible circuit substrates at their respective first longitudinal edges and at their respective second longitudinal edges such that the first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and the second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member ([0053], [0055]- [0056] discuss the spine as containing elements such as apertures which provide gaps within the non-conductive covering at predetermined positions so as to align to a degree with the electrodes positioning).
However, Aujla fails to specifically teach the at least one flexible circuit substrate including a first flexible circuit substrate and a second, separate flexible circuit substrate.
Therefore, while Aujla does not explicitly teach the method wherein the at least one flexible circuit substrate includes a first flexible circuit substrate and a second, separate flexible circuit substrate, there is no evidence that more than one of the structural members makes a meaningful difference to the function of the device compared to the currently taught structural member and it has been held that a duplication of parts is an obvious modification (MPEP 2144.04(VI)(B)).
Regarding claim 13, Aujla teaches the method of claim 1.
While Aujla does not explicitly teach the method wherein the structural member includes a plurality of discrete members, there is no evidence that more than one of the structural members makes a meaningful difference to the function of the device compared to the currently taught structural member and it has been held that a duplication of parts is an obvious modification (MPEP 2144.04(VI)(B)).
Regarding claim 18, Aujla teaches the electrode assembly of claim 17, wherein the flexible circuit assembly includes a first flexible circuit substrate, the first flexible circuit substrates including first and second longitudinal edges (Fig. 11; non-conductive coverings 44);
wherein the structural member is positioned between the first flexible circuit substrates ([0048]- [0050]); and
wherein the first flexible circuit substrates are coupled at their respective first longitudinal edges and at their respective second longitudinal edges such that the first set of electrodes of the plurality of electrodes is aligned with the first surface of the structural member and the second set of electrodes of the plurality of electrodes is aligned with the second surface of the structural member ([0053], [0055]- [0056]).
However, Aujla fails to specifically teach the at least one flexible circuit substrate including a first flexible circuit substrate and a second, separate flexible circuit substrate.
Therefore, while Aujla does not explicitly teach the method wherein the at least one flexible circuit substrate includes a first flexible circuit substrate and a second, separate flexible circuit substrate, there is no evidence that more than one of the structural members makes a meaningful difference to the function of the device compared to the currently taught structural member and it has been held that a duplication of parts is an obvious modification (MPEP 2144.04(VI)(B)).
Claim 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20180056038 A1) in view of Metzger (US 5117828 A) further in view of Kordis (US 5911739 A).
Regarding claim 14, Aujla teaches the method of claim 1.
However, Aujla fails to teach the method further comprising incorporating the formed spline into a planar electrode assembly.
Kordis teaches an expandable electrode assembly for use in medical procedures containing a plurality of individual splines including electrodes on the surface of said splines (Abstract).
Kordis further teaches the expandable electrode assembly as being expandable into a plurality of configurations such as those containing splines in a variety of planar, flat, expanded or other configurations as is necessary to conform to a surface of a patient’s tissue ([0077]- [0079]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrode assembly as being capable of conforming into a variety of shapes, as is taught by Kordis, into the electrode assembly having a plurality of splines as is taught by Aujla, to produce the predictable result of conforming to patient tissue, as is taught by Kordis, 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 16, in accordance with the above rejection of claim 14, Kordis further teaches the method of claim 1, further comprising rolling the at least one flexible circuit substrate about a length of the at least one flexible circuit substrate to form a spiral configuration ([0077]- [0079]).
Claim 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Aujla (US 20180056038 A1) in view of Metzger (US 5117828 A) further in view of Basu (US 20200297281 A1).
Regarding claim 7, Aujla teaches the method of claim 1.
However, Aujla fails to teach the method wherein the flexible circuit assembly includes a first flexible circuit substrate and a second flexible circuit substrate joined to the first flexible circuit at a fold line, wherein forming the spline comprises folding the first flexible circuit substrate relative to the second flexible circuit substrate about the fold line and around the structural member such that the first set of electrodes is aligned with the first surface of the structural member and the second set of electrodes is aligned with the second surface of the structural member.
Basu teaches an apparatus including a shaft and an end effector at the distal end of the shaft, the end effector comprising a plurality of spines (Abstract, [0030], [0039]).
Basu further teaches a known configuration of providing electrodes along the support member of a spine where the electrodes are provided in a panel which is affixed to the outer surface of the spine containing the support member and the panel is folded along the longitudinal axis so as to be provided over the support member ([0037], [0039]- [0040]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known manner of connected an electrode to a support member of a spine, as is taught by Basu, into the splines containing electrodes as is taught by Aujla, to produce the predictable result of and electrode connected to a spine, as is taught by Basu, 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 19, Aujla teaches the electrode assembly of claim 17,
However, Aujla fails to teach the electrode assembly wherein the flexible circuit assembly includes at least two flexible circuit substrates joined at a fold line, wherein the flexible circuit assembly is folded about the fold line and around the structural member such that the first set of electrodes is aligned with the first surface of the structural member and the second set of electrodes is aligned with the second surface of the structural member teaches this.
Basu teaches an apparatus including a shaft and an end effector at the distal end of the shaft, the end effector comprising a plurality of spines (Abstract, [0030], [0039]).
Basu further teaches a known configuration of providing electrodes along the support member of a spine where the electrodes are provided in a panel which is affixed to the outer surface of the spine containing the support member and the panel is folded along the longitudinal axis so as to be provided over the support member ([0037], [0039]- [0040]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known manner of connected an electrode to a support member of a spine, as is taught by Basu, into the splines containing electrodes as is taught by Aujla, to produce the predictable result of and electrode connected to a spine, as is taught by Basu, 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).
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 Aujla reference are moot in view of the new rejections under Aujla and Metzger.
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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