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 .
Response to Amendment
The Amendments filed December 30, 2025 have been entered. Applicant’s amendments have overcome the Drawing objection previously set-forth in the Non-Final Rejection mailed on 09/30/2025. Currently, claims 1, 3, 5-6, 15-16 have been amended, claims 7 and 17 have been cancelled, claim 21 has been newly added, 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 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Basu (U.S. Application No. 20170164858 A1).
Regarding independent claim 1, Basu discloses a one-piece flex circuit (18) (pa. 0034 & Fig. 1) comprising a proximal end (i.e., region 34 where electrode array assembly is joined to catheter body 12) and extending along a longitudinal axis to a distal end (36) (pa. 0039 & Fig. 4), the proximal end diverging into a plurality of first arms (see annotated Fig. 4 below), each of the first arms connected to a second arm extending distally to a third arm connected to the distal end (see annotated Fig. 4 below), a fourth arm and a fifth arm diverging from the first arm at a point where the first arm and the second arm are connected (see annotated Fig. 4 below), the fourth arm and the fifth arm extending distally and converging together at a point where the second arm and third arm are connected to each other (see annotated Fig. 4 below) to define an elongated shape disposed about the longitudinal axis (see annotated Fig. 4 below).
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Regarding claim 4, Basu discloses the one-piece flex circuit being configured to transition between an expanded form and a collapsed form (pa. 0035).
Claims 5-6, 11-16, 18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagale (U.S. Application No. 20170035497 A1).
Regarding independent claim 5 and claim 18, Nagale discloses a medical probe (10) (pa. 0028 & Fig. 1), comprising:
a structural unit (20) for an end effector (pa. 0028), the structural unit comprising:
a proximal hub (24);
a distal hub (22) positioned a distance along a longitudinal axis away from the proximal hub (pa. 0028); and
a plurality of spines (combination of splines 23 and struts 25, pa. 0028 & Fig. 2) extending between the proximal hub and the distal hub and forming a generally cylindrical structure (see Fig. 2), the plurality of spines comprising:
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a plurality of first members (combination of two splines) attached to the proximal hub (see annotated Fig. 2 below), the plurality of first members diverging into a plurality of second (combination of one strut, one spline, and another strut) and third members (combination of one strut, one spline, and another strut) (see annotated Fig. 2 below), each of the second and third members converging together to a first end of a respective fourth member proximate the distal hub (see annotated Fig. 2 below); and
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a flexible circuit (printed along the inner or outer surface of the splines and/or struts of the structural unit) coupled to the structural unit (pa. 0029), the flexible circuit comprising a proximal end (region 24) and a distal end (region 22) (pa. 0028), the proximal end diverging into a plurality of first arms (combination of the flexible circuit printed on two splines, see newly annotated Fig. 2 below), each of the first arms dividing into second and third arms (each of the second and third arms being a combination of the flexible circuit printed on one strut, one spline, and another strut, see newly annotated Fig. 2 below), each of the second and third arms connected to respective fourth arms (combination of the flexible circuit printed on one spline, see newly annotated Fig. 2 below) proximate the distal end.
Regarding claims 6 and 16, Nagale discloses each of the respective fourth members having a second end diverging into fifth and sixth members (both the fifth and the sixth members being a combination of one strut and one spline), each of the fifth and sixth members connected to the distal hub (see annotated Fig. 2 below).
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Regarding claim 11, Nagale discloses each first arm of the plurality of first arms being aligned with a first member of the plurality of first members (pa. 0029).
Regarding claim 12, Nagale discloses each second arm being aligned with a second member (pa. 0029).
Regarding claim 13, Nagale discloses each third arm being aligned with a third member (pa. 0029).
Regarding claim 14, Nagale discloses each fourth arm being aligned with a fourth member (pa. 0029).
Regarding independent claim 15, Nagale discloses a method of constructing a medical probe (10) (pa. 0028 & Fig. 1), the method comprising:
forming a plurality of spines (combination of splines 23 and struts 25, pa. 0028 & Fig. 2), the plurality of spines forming a substantially cylindrical shape (see Fig. 2), the plurality of spines comprising:
a plurality of first members (combination of two splines, see annotated Fig. 2 on page 6 above) attached to a proximal hub (24) (pa. 0028), the plurality of first members diverging into a plurality of second and third members (each of the second and the third members being a combination of one strut, one spline, and another strut, see annotated Fig. 2 on page 6 above), each of the second and third members converging together to a first end of a respective fourth member (see annotated Fig. 2 on page 6 above) proximate a distal hub (22) (pa. 0028);
forming a flexible circuit (printed along the inner or outer surface of the splines and/or struts of the structural unit) including a plurality of electrodes (40) (pa. 0029 & Fig. 1);
coupling the flexible circuit to the plurality of spines to form a cylindrical structure (see Fig. 2); and
attaching the cylindrical structure to a distal end of a tubular shaft (12) (pa. 0028).
Regarding claim 19, Nagale discloses wherein:
each first arm of the plurality of first arms being aligned with a first member of the plurality of first members (pa. 0029);
each second arm being aligned with a second member (pa. 0029);
each third arm being aligned with a third member (pa. 0029); and
each fourth arm being aligned with a fourth member (pa. 0029).
Regarding claim 21, Nagale 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 (see annotated Fig. 2 on page 6).
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Basu as applied to claim 1 above, and further in view of Gliner (U.S. Application No. 20200129128 A1).
Regarding claim 2, Basu discloses a plurality of electrodes (20) configured to ablate tissue of an organ of a patient (pa. 0004, 0033).
However, Basu 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 splines of Basu 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 3, Basu 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 one-piece flex circuit (pa. 0001, 0033-0034).
However, Basu does not disclose wherein 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 added the reference electrodes of Gliner to the inwardly-facing surface of the splines of Basu for the purpose of detecting far-field signals, particularly those conducted by blood, which leads to accurate cardiac mapping and successful ablation therapy.
Claims 8-9, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nagale as applied to claims 5 and 15 above, and further in view of Gliner (U.S. Application No. 20200129128 A1).
Regarding claim 8, Nagale discloses a plurality of electrodes (40) configured to ablate tissue of an organ of a patient (pa. 0029).
However, Nagale 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 Nagale 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, Nagale/Gliner combination discloses the flexible circuit further comprising a plurality of electrical traces, each electrical trace of the plurality of electrical traces being in electrical communication with a respective electrode of the plurality of electrodes (Nagale, pa. 0029).
Although not explicitly stated, it is inferred that the flexible circuit of Nagale contains a plurality of electrical traces since they allow electrical coupling between the electrodes and an electrical activity processing system and ablation energy source.
Regarding claim 20, Nagale discloses the plurality of electrodes being disposed on an outwardly-facing surface of the one-piece flex circuit (pa. 0029).
However, Nagale 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 Nagale for the purpose of detecting far-field signals, particularly those conducted by blood, which leads to accurate cardiac mapping and successful ablation therapy.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nagale as applied to claim 5 above, and further in view of Basu (U.S. Application No. 20170164858 A1).
Regarding claim 10, Nagale discloses the invention substantially as claimed in claim 5 discussed above.
However, Nagale does not disclose an electromagnetic coil.
Basu, in the same field of endeavor, teaches a cylindrical structure (18) comprising an electromagnetic coil (56) attached to the cylindrical structure, the electromagnetic coil configured to sense a magnetic field for position sensing, thereby enabling a processor to determine a position, (e.g., the location and orientation) of the distal end of the cylindrical structure within the tissue (pa. 0047).
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 electromagnetic coil of Basu to the medical probe of Nagale for the purpose of providing information regarding location and orientation of the distal end of the end effector when it is inside/approaching the target tissue.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 12/30/2025, with respect to the 102
rejection of claim 1 under Basu have been fully considered and are persuasive. Specifically, Applicant’s amendments to claim 1 to further require the one-piece flex circuit to comprise each of the first arms connected to a second arm extending distally to a third arm connected to the distal end, a fourth arm and a fifth arm diverging from the first arm at a point where the first arm and the second arm are connected, the fourth arm and the fifth arm extending distally and converging together at a point where the second arm and third arm are connected to each other is defined over the first interpretation of Basu given that it does not contemplate this claimed structure. Therefore, the rejection has been withdrawn. However, upon further consideration, a new interpretation of the Basu reference has been set forth in the action above.
It is the Examiner’s position that the newly filed rejections based on the new interpretation of Basu is tenable for at least the reasoning set forth in the action above.
Applicant’s arguments, see pages 7-8, filed 12/30/2025, with respect to the 102
rejection of claims 5 and 15 under Basu and the 102 rejection of claims 5 and 15 under a new interpretation of Basu previously set-forth have been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 5 and 15 to further require the medical probe to comprise a plurality of first members diverging into a plurality of second and third members, each of the second and third members converging together to a first end of a respective fourth member proximate the distal hub is defined over all of Basu’s previous interpretations given that they do not contemplate this claimed structure. 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, 11-16, 18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagale (U.S. Application No. 20170035497 A1).
It is the Examiner’s position that the newly filed rejections based on the Nagale reference is tenable for at least the reasoning set forth in the action above.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794