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 .
Applicant’s arguments filed in the reply on May 22, 2026 were received and fully considered. Claims 1-2, 4 and 9 were amended. Claims 3 and 8 were cancelled. Please see below for more detail.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and claims dependent thereon rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding Claim 1, the term “a shape support structure of each of the plurality of base materials" renders the claim indefinite because it is unclear if the singular shape support structure is intended to support all of the plurality of base materials or if there is a singular support structure for each of the plurality of base materials. Reviewing the Specification dated 2/08/2024, paragraph [0015] teaches the shape support structure being applied for a single base material 14 and paragraph [0016] teaches that each base material has an independent lumen within the catheter for deployment. This indicates the latter interpretation is more likely. Appropriate changes would include -- a shape support structure [[of]] for each of the plurality of base materials – with corresponding changes of
-- wherein the shape support structures are shape memory members,
wherein each [[the]] shape memory member comprises a first portion extending along a periphery of each of the plurality of base materials and a second portion extending along a direction intersecting a main surface of each of the plurality of base materials, and
wherein the first portion and the second portion are formed of one continuous wire rod.--and corresponding changes in Claim 9. Examiner will be interpreting the claim as such.
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 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marecki et al (US 2015/0351652) (“Marecki”) in view of Ruppersberg (US 2019/0183372) and further in view of Urman et al (US 2012/0172697) (“Urman”).
Regarding Claim 1, while Marecki teaches an electrode catheter (Abstract, [0002], [0005], [0074], [0076] intravascular catheter 10 includes an expandable electrode assembly 30 for various purposes, Figs. 3A-3G, [0077] expandable electrode assembly 30 supports a plurality of electrodes 64 with various possible geometries), comprising
A plurality of shape support structures (Figs. 3A-3G, [0077] flexible member 60 supports a plurality of electrodes 64); and
a plurality of electrodes provided on each of the shape support structures (Figs. 3A-3G, [0077]),
wherein at least some of the plurality of electrodes are exposed on a front surface and a back surface of each of the shape support structures (Figs. 3A-3G, [0077], [0083] electrodes 64 may be on each side of flexible members/splines 50),
wherein the shape support structures are shape memory members ([0097] shape support structure / flexible member/flexible spline 60 utilize a relatively stiff substrate 86 to facilitate shape retention, the substrate potentially comprising a shape memory material such as Nitinol),
wherein the shape memory member comprises a first portion extending along a periphery of a created shape and a second portion extending along a direction away from the created shape (Fig. 3a-3g, [0077] first portion of the shape memory member / splines 60 create a shape by acting as the periphery of said shapes as shown in the various figures, [0102]-[0103] splines may be affixed to the catheter body with a termination section comprising tabs at the proximal end of the splines, fitting into slots of the catheter body, the tabs representing the second portion), and
wherein the first portion and the second portion are formed of one continuous wire rod (Figs. 3D and 3G, show created shapes by single continuous splines, with unshown termination section tabs extending into a slot of the catheter body, [0079], [0097] relatively stiff substrate 86 of Nitinol within spline acting making it a wire rod).
Marecki fails to teach
wherein the shape memory member comprises a first portion extending along a periphery of each of the plurality of base materials and a second portion extending along a direction intersecting a main surface of each of the plurality of base materials.
However Ruppersberg teaches an electrode catheter (Abstract, Figs. 1, 3, and 7, catheter 110) comprising:
a plurality of shape support structures ([0083] splines 126); and
a plurality of electrodes provided on each of the shape support structures ([0086] splines 126 include a plurality of electrodes 122),
wherein the shape support structures are shape memory members ([0090] characterized by their use of Nitinol),
wherein the shape memory member comprises a first portion extending along a periphery of a created shape and a second portion extending along a direction intersecting a main surface of each of the created shapes (Fig. 7, [0118] splines 126 extend perpendicularly from catheter body 106 and creates four bounded shapes, connected to create a fan-like structure, [0141] where the splines will fit within distal portion of the catheter body and then extend outwards, indicating that portions of the spline remain within the catheter body).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that a created shape in Marecki could extend at an angle or perpendicularly as taught by Ruppersberg’s Fig. 7, in which case the second portion of the Marecki’s spline extend in a parallel direction to the catheter distal end, a direction that would intersect a surface created by a shape of the spline when oriented perpendicularly from the catheter body. This would be the natural cause of the utilization of a fan shape taught by Rupperdberg, one of many geometries that may be desirable by Marecki.
Yet their combined efforts fail to teach
a plurality of base materials each having a thin-film shape;
a shape support structure of each of the plurality of base materials;
a plurality of electrodes provided on each of the plurality of base materials
wherein at least some of the plurality of electrodes are exposed on a front surface and a back surface of each of the plurality of base materials,
wherein the shape memory member comprises a first portion extending along a periphery of each of the plurality of base materials and a second portion extending along a direction intersecting a main surface of each of the plurality of base materials.
However 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), and
wherein the shape of the base material can be provided by the shape support structure at the shape’s periphery ([0025]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply a deployable sheet as taught by Urman with the created shapes of Marecki as this will increase the potential monitoring area of the splines by enabling electrodes to be both placed in the periphery of the created shape and within the space of the created shape. And in applying the base materials to the plurality of created shapes from the fan of Marecki and Ruppersberg, you will be utilizing a plurality of base materials each having a thin-film shape.
Regarding Claim 2, Marecki, Ruppersberg, and Urman teach the electrode catheter according to claim 1, wherein at least some of the plurality of electrodes are along the front surface of each of the plurality of base materials, and a remainder of the plurality of electrodes extend along the back surface of each of the plurality of base materials (See Claim 1 Rejection), and Marecki further teaches wherein the plurality of electrodes are each connected to a conducting layer that extends along the inside surface of the front and back electrode mounting areas (Fig. 6, [0096]-[0097] electrode assembly and electrodes are formed by outer metallization layers that connect with shared inner metallization layers) and Urman teaches wherein the plurality of electrodes are each connected by a conducting wire ([0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to structure the inner conductive layer of Marecki as a wire as taught by Urman as a specific example of one of many manners of structuring conductive wires, standardizing the construction in mapping catheters and ensuring consistency in results. Furthermore, it would be obvious to extend the conductive layers/wires into the base material of Urman to provide an electrical connection and sensing capability to the electrodes on the base materials, enabling the increase in sensing surface area.
Regarding Claim 4, Marecki, Ruppersberg, and Urman teach the electrode catheter according to claim 1, and Marecki teaches the catheter comprising:
wherein the electrode catheter further comprises a shaft that holds a root of each of the plurality of the base materials (See Claim 1 Rejection, catheter will hold a root of each of the plurality of the base materials prior to deployment); and
Ruppersberg teaches a connecting member that connects adjacent ones of the plurality of the base materials ([0089] tendon or chords 115 connect adjacent one of the plurality of arm, that would include a base material as outlined in the Rejection of Claim 1), 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. 7, [0089] shapes created by separate splines 126 are arranged circumferentially around the shaft / catheter body 106 and [0118]-[0120] with arms being capable of being in a contracted state within catheter and expanded state when deployed from catheter).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the applied fan shape for an electrode mapping catheter of Marecki and Ruppersberg further include a connecting member as taught by Rupperberg as Ruppersberg teaches that this addition facilitates the predetermined positioning in Ruppersberg upon deployment.
Regarding Claim 5, Marecki, Ruppersberg, and Urman teach the electrode catheter according to claim 4, wherein at least some of the plurality of electrodes are along the front surface of each of the plurality of base materials, and a remainder of the plurality of electrodes extend along the back surface of each of the plurality of base materials (See Claim 1 Rejection), and Marecki further teaches wherein the plurality of electrodes are each connected to a conducting layer that extends along the inside surface of the front and back electrode mounting areas (Fig. 6, [0096]-[0097] electrode assembly and electrodes are formed by outer metallization layers that connect with shared inner metallization layers) and the front-side conducting layer and the back-side conducting layer are axially provided on outer surfaces of a root along the root of the shape support structure (Fig. 6, [0097] a root of the shape support structure can be the substrate 86 itself, where its extension into the electrode catheter provides a root function to the deployed base material, where the metallization layers acting as the conducting layers of the electrodes are axially provided on outer surfaces of root / substrate 86), and Urman teaches wherein the conductive layer connecting the plurality of electrodes is a conducting wire ([0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to structure the inner conductive layer of Marecki as a wire as taught by Urman as a specific example of one of many manners of structuring conductive wires, standardizing the construction in mapping catheters and ensuring consistency in results. Furthermore, it would be obvious to extend the conductive layers/wires into the base material of Urman to provide an electrical connection and sensing capability to the electrodes on the base materials, enabling the increase in sensing surface area. Finally, it would have been obvious to have the conducting layers on the outer surfaces of the root as the electrode must be on the outermost surface to interface with the patient’s anatomy and the conducting layer must connect to the electrode to transmit the electrode’s acquired data.
Regarding Claim 6, Marecki, Ruppersberg, and Urman teach the electrode catheter according to claim 5, 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 (See Claim 5 Rejection, Marecki’s Fig. 6 will has the root / substrate 86 with surfaces facing both sides, where a similar conductive connection to the base material, having electrodes on both front and back surfaces, will also require such a configuration),
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 6 Rejection, with such a configuration occurring due to the teachings of Marecki).
Regarding Claim 7, Marecki, Ruppersberg, and Urman teach the electrode catheter according to claim 1, and Marecki further teaches the catheter comprising: 20 or more of the plurality of electrodes ([0083]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marecki in view of Ruppersberg and further in view of Urman and further in view of Fang (US 2013/0253504) and further in view of Prakash et al (US 2011/0218527) (“Prakash”).
Regarding Claim 9, while Marecki, Ruppersberg, and Urman teach a potential detection method using the electrode catheter according to claim 1 ([0074]-[0077), and Marecki teaches using an electrode catheter comprises:
expanding the plurality of base materials supported by the shape support structures in a contracted state (See Claim 1 Rejection, deployed shapes will include base materials, Marecki: [0074]-[0077] catheter’s electrode assembly 30 deployed at a target location at within a heart);
contacting the surface of each of some of the plurality of base materials with a potential detection target surface (See Claim 1 Rejection, deployed shapes will include base materials, Marecki: [0077]-[0079] once deployed, the electrode assembly is placed in contact with target tissue of interest and splines may be structured to map across the heart anatomy as desired), where the contacting may occur at a front surface or a back surface (See Claim 1 Rejection), their combined efforts fail to teach while contacting the front surface of each of some of the plurality of base materials with a potential detection target surface, contacting the back surface of each of a remainder of the plurality 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 Marecki, Ruppersberg, and Urman as distinct shapes with shape support structure as taught by Prakash can be an alternative geometry within Marecki that does not requires the connecting member of Ruppersberg to map an area of the heart. And Fang teaches that the flexibility provided by distinct electrode array sections for independent action would enable a functionality of Marecki’s both front and back electrodes, clarifying how front and back electrodes can be used for mapping, 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 by independent action of Marecki’s shapes.
Response to Arguments
Applicant’s amendments and arguments filed 5/22/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Marecki, Ruppersberg, and Urman.
Consequently, Claims 2, 4-7, and 9 remain rejected due to their dependency on rejected independent Claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights