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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/22/2026 has been entered.
Response to Amendment
The Amendments filed June 22, 2026 have been entered. Currently, claims 1, 5, and 15 have been amended, and claims 1-6, 8-16, 18-21 are pending in the application.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 5-6, 10-16, 18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (U.S. Application No. 20180360533 A1).
Regarding independent claim 5 and claim 18, Olson discloses a medical probe (12) (pa. 0037 & Fig. 1), comprising:
a structural unit (40) for an end effector (pa. 0052 & Fig. 3A), the structural unit comprising:
a proximal hub (see first annotated Fig. 3A below);
a distal hub (see first annotated Fig. 3A below) positioned a distance along a longitudinal axis away from the proximal hub; and
a plurality of spines extending between the proximal hub and the distal hub and forming a generally cylindrical structure (pa. 0053), the plurality of spines comprising:
a plurality of first members (combination of two proximal-most splines) attached to the proximal hub (see second annotated Fig. 3A below), the plurality of first members diverging into a plurality of second and third members (each a combination of two connecting splines) at respective first points (see second annotated Fig. 3A below), each of the second and third members converging together to a respective second point (see second annotated Fig. 3A below) at a first end of a respective fourth member (combination of two sets of connecting splines, with a total of four splines) proximate the distal hub, each of the second and third members connecting directly to only one of the respective first points (see second annotated Fig. 3A below), the second and third members connecting to the proximal hub only through routes which pass through one of the respective first points (see second annotated Fig. 3A below);
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and
a flexible circuit (a flexible substrate, not shown, connected or attached to one or more locations of the structural unit) coupled to the structural unit (pa. 0058), the flexible circuit comprising a proximal end (region that comprises the proximal hub on the structural unit) and a distal end (region that comprises the distal hub on the structural unit), the proximal end diverging into a plurality of first arms (same location as the plurality of first members annotated on the figure above), each of the first arms dividing into second and third arms (same location as the second and third members annotated on the figure above), each of the second and third arms connected to respective fourth arms (same location as the fourth member annotated on the figure above) proximate the distal end.
Regarding claims 6 and 16, Olson discloses each of the respective fourth members having a second end diverging into fifth and sixth members (each a combination of two connecting splines, see annotated Fig. 3A below), each of the fifth and sixth members (indirectly) connected to the distal hub.
Examiner notes the claim language is vague and does not require the fifth and the sixth member to be directly connected to the distal hub.
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Regarding claim 10, Olson discloses an electromagnetic coil (44) attached to the cylindrical structure, the electromagnetic coil configured to sense a magnetic field for position sensing (pa. 0041, 0056).
Regarding claim 11, Olson discloses each first arm of the plurality of first arms being aligned with a first member of the plurality of first members (pa. 0058).
Regarding claim 12, Olson discloses each second arm being aligned with a second member (pa. 0058).
Regarding claim 13, Olson discloses each third arm being aligned with a third member (pa. 0058).
Regarding claim 14, Olson discloses each fourth arm being aligned with a fourth member (pa. 0058).
Regarding independent claim 15, Olson discloses a method of constructing a medical probe (12) (pa. 0037 & Fig. 1), the method comprising:
forming a plurality of spines, the plurality of spines forming a substantially cylindrical shape (pa. 0053), the plurality of spines comprising:
a plurality of first members (combination of two proximal-most splines, see second annotated Fig. 3A under the rejection of independent claim 5) attached to a proximal hub (see first annotated Fig. 3A under the rejection of independent claim 5), the plurality of first members diverging into a plurality of second and third members (each a combination of two connecting splines, see second annotated Fig. 3A) at respective first points (see second annotated Fig. 3A), each of the second and third members converging together to a respective second point (see second annotated Fig. 3A) at a first end of a respective fourth member (combination of two sets of connecting splines, with a total of four splines, see second annotated Fig. 3A) proximate a distal hub, each of the second and third members connecting directly to only one of the respective first points (see second annotated Fig. 3A), the second and third members connecting to the proximal hub only through routes which pass through one of the respective first points (see second annotated Fig. 3A);
forming a flexible circuit (a flexible substrate, not shown, connected or attached to one or more locations of the structural unit) including a plurality of electrodes (50) (pa. 0058, 0060);
coupling the flexible circuit to the plurality of spines to form a cylindrical structure (pa. 0053, 0058); and
attaching the cylindrical structure to a distal end of a tubular shaft (22A) (pa. 0053).
Regarding claim 19, Olson discloses wherein:
each first arm of the plurality of first arms being aligned with a first member of the plurality of first members (pa. 0058);
each second arm being aligned with a second member (pa. 0058);
each third arm being aligned with a third member (pa. 0058); and
each fourth arm being aligned with a fourth member (pa. 0058).
Regarding claim 21, Olson discloses at least a portion of the first members, the second members, the third members, and the fourth members extending substantially straight in an axial direction relative to the longitudinal axis to define the substantially cylindrical shape in an expanded form of the end effector (pa. 0053).
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.
Claims 8-9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Olson as applied to claims 5 and 15 above, and further in view of Gliner (U.S. Application No. 20200129128 A1).
Regarding claim 8, Olson discloses a plurality of electrodes (50) configured to ablate tissue of an organ of a patient (pa. 0059-0060 & Fig. 3A).
However, Olson does not disclose a plurality of reference electrodes.
Gliner, in the same field of endeavor, teaches an expandable frame (39) comprising a plurality of spines (45) made of flexible PCB (pa. 0045), wherein the each of the spines contain a plurality of outer electrodes (50) contacting the tissue and a plurality of inner reference electrodes (55) configured to acquire far-field signals (pa. 0043, 0045 & Fig. 2A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the reference electrodes of Gliner to the spines of Olson for the purpose of detecting far-field signals, particularly those conducted by blood, which leads to accurate cardiac mapping and successful ablation therapy.
Regarding claim 9, Olson/Gliner combination discloses the flexible circuit further comprising a plurality of electrical traces (46), each electrical trace of the plurality of electrical traces being in electrical communication with a respective electrode of the plurality of electrodes (Olson, pa. 0058-0059).
Regarding claim 20, Olson discloses the plurality of electrodes being disposed on an outwardly-facing surface of the flex circuit (see Fig. 3A).
However, Olson does not disclose attaching a plurality of reference electrodes to the cylindrical structure, each reference electrode of the plurality of reference electrodes being positioned proximate a respective electrode of the plurality of electrodes and attached to a respective spine of the plurality of spines on a side of the respective spine opposite each respective electrode of the plurality of electrodes.
Gliner, in the same field of endeavor, teaches an expandable frame (39) comprising a plurality of spines (45) made of flexible PCB (pa. 0045), wherein the each of the spines contain a plurality of outer electrodes (50) contacting the tissue and a plurality of inner reference electrodes (55) configured to acquire far-field signals (pa. 0043, 0045 & Fig. 2A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the reference electrodes of Gliner to the inwardly-facing surface of the spines of Olson for the purpose of detecting far-field signals, particularly those conducted by blood, which leads to accurate cardiac mapping and successful ablation therapy.
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke (U.S. Application No. 20180161577 A1), and further in view of Chou (U.S. Application No. 20150366508 A1).
Regarding independent claim 1, Goedeke discloses a flex circuit (a flexible polymeric material, pa. 0700) comprising a proximal end and extending along a longitudinal axis to a distal end (see annotated Fig. 36C below), the proximal end diverging into a plurality of first arms (see annotated Fig. 36L below), each of the first arms connected to a second arm extending distally to a third arm connected to the distal end (pa. 0842, see annotated Fig. 36L below), a fourth arm and a fifth arm diverging from the first arm at a first point where the first arm and the second arm are connected (see annotated Fig. 36L below), the fourth arm and the fifth arm extending distally and converging together at a second point where the second arm and third arm are connected to each other to define an elongated shape disposed about the longitudinal axis (see annotated Fig. 36L below), the fourth arm and the fifth arm connecting to the proximal end only through respective routes which pass through respective first points of the plurality of first arms (see Fig. 36C).
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Examiner notes that all the annotations seen in Fig. 36L are made on separate spines for the sake of clarity, but each markup is intended to be contained on a single spine of the flex circuit.
However, Goedeke does not disclose the flex circuit being a one-piece flex circuit.
Chou, in the same field of endeavor, teaches a flex-PCB catheter (100) comprising a plurality of splines (120) that include at least one flex-PCB layer. The flex-PCB layer includes at least one flex-PCB substrate (200) on the splines, in which a plurality of active elements are provided with accompanying communication paths (pa. 0077 & Fig. 1). The flex-PCB substrate can be a single or multi-layer flex-PCB layer made as a single work piece. For example, the flex-PCB substrate can be laser cut from a single piece of flex-PCB material in order to reduce manufacturing complexity, time, and cost (pa. 0119).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the spaced arm, and therefore flex circuit, arrangement of Goedeke with the flex-PCB layer made as a single work piece taught by Chou in order to reduce manufacturing complexity, time, and cost (Chou, pa. 0119).
Regarding claim 2, Goedeke/Chou combination discloses further comprising a plurality of electrodes (3624) (Goedeke, pa. 0440, 0827) configured to ablate tissue of an organ of a patient and a plurality of reference electrodes (Goedeke, pa. 0587, 0672, 0701).
Regarding claim 4, Goedeke discloses the flex circuit being configured to transition between an expanded form and a collapsed form (see Fig. 36B-36C).
However, Goedeke does not disclose the flex circuit being a one-piece flex circuit.
Chou, in the same field of endeavor, teaches a flex-PCB catheter (100) comprising a plurality of splines (120) that include at least one flex-PCB layer. The flex-PCB layer includes at least one flex-PCB substrate (200) on the splines, in which a plurality of active elements are provided with accompanying communication paths (pa. 0077 & Fig. 1). The flex-PCB substrate can be a single or multi-layer flex-PCB layer made as a single work piece. For example, the flex-PCB substrate can be laser cut from a single piece of flex-PCB material in order to reduce manufacturing complexity, time, and cost (pa. 0119).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the spaced arm, and therefore flex circuit, arrangement of Goedeke with the flex-PCB layer made as a single work piece taught by Chou in order to reduce manufacturing complexity, time, and cost (Chou, pa. 0119).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Goedeke and Chou as applied to claim 1 above, and further in view of Gliner (U.S. Application No. 20200129128 A1).
Regarding claim 3, Goedeke discloses each electrode of the plurality of electrodes configured to ablate tissue of an organ of a patient being disposed on an outwardly-facing surface of the flex circuit (pa. 0440, 0827 & Fig. 36C). Moreover, Goedeke further discloses a plurality of reference electrodes proximate to the plurality of electrodes (pa. 0587, 0672, 0701).
Chou teaches the one-pieced flex circuit (pa. 0119).
However, they do not disclose each reference electrode of the plurality of reference electrodes being disposed on an inwardly-facing surface of the one-piece flex circuit.
Gliner, in the same field of endeavor, teaches an expandable frame (39) comprising a plurality of spines (45) made of flexible PCB (pa. 0045), wherein the each of the spines contain a plurality of outer electrodes (50) contacting the tissue and a plurality of inner reference electrodes (55) configured to acquire far-field signals (pa. 0043, 0045 & Fig. 2A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the reference electrodes of Goedeke to be in the inwardly-facing surface of the spines of as taught by Gliner for the purpose of detecting far-field signals, particularly those conducted by blood, which leads to accurate cardiac mapping and successful ablation therapy.
Response to Arguments
Applicant’s arguments, see pages 6-12, filed 06/22/2026, with respect to the 102
rejection of claim 1 under Basu and the 102 rejections of claims 5 and 15 under Nagale have been fully considered and are persuasive. Specifically, Applicant’s amendments to claim 1 to require the fourth arm and the fifth arm connecting to the proximal end only through respective routes which pass through respective first points of the plurality of first arms, and the amendments to claims 5 and 20 to further require each of the second and third members connecting directly to only one of the respective first points, the second and third members connecting to the proximal hub only through routes which pass through one of the respective first points is defined over Basu and Nagale given that neither contemplate these claimed structures. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 5-6, 10-16, 18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson (U.S. Application No. 20180360533 A1).
Claims 8-9, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Olson as applied to claims 5 and 15 above, and further in view of Gliner (U.S. Application No. 20200129128 A1).
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke (U.S. Application No. 20180161577 A1), and further in view of Chou (U.S. Application No. 20150366508 A1).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Goedeke and Chou as applied to claim 1 above, and further in view of Gliner (U.S. Application No. 20200129128 A1).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasonings set forth in the action above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ruppersberg (US 20200121208 A1) teaches various examples and embodiments of a cardiac mapping catheter configured for electrophysiological (EP).
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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