DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Prosecution Reopened
In view of the Appeal Brief filed on 05/12/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejections is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-6, 10-12, 20-23, 25-27, and 29 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Imran (E.P. Application No. 0573311 B1).
Regarding independent claim 1, Imran discloses an electrophysiology catheter (12) (pa. 0014 & Fig. 1), comprising:
an elongate, deformable shaft (combination of flexible elongated members 16 and 41) comprising a proximal end and a distal end (pa. 0014); and
a basket electrode assembly (combination of expandable means 27, which comprises a plurality of flexible arms 28, and a distal extremity 56) coupled to the distal end of the shaft (pa. 0014, 0017), the basket electrode assembly configured to assume a compressed state and an expanded state (pa. 0015, 0023), the basket electrode assembly further comprising:
an inner structure (56) comprising an inner supporting body (combination of conductor 51, insulating layer 52, and flexible elongate elements 63, 65, 67) and an inner electrode (54) disposed thereon (pa. 0017, 0020 & Figs. 2-3); and
an outer structure (28) comprising an outer supporting body (including conductors 34) and a plurality of outer electrodes (26) disposed thereon (pa. 0014, 0016 & Fig. 2),
wherein the inner electrode is positioned within an envelope defined by the outer structure when the basket electrode assembly is in the expanded state (see Figs. 1-2), wherein the inner electrode is spaced apart from the outer electrodes and configured to not contact tissue (i.e., in close proximity) when the basket electrode assembly is in the expanded state (pa. 0022).
For further clarification, Examiner notes that the expanded state of the inner structure comprising an inner supporting body is when it is slidably positioned outside lumen (21) and/or when it is bent in various directions extending about 360° of the longitudinal axis of the catheter (pa. 0013, 0023).
Furthermore, regarding the claim limitation “wherein the inner electrode is … configured to not contact tissue when the basket electrode assembly is in the expanded state”, the expanded configuration of the basket electrode assembly is when the outer structure bows outward and when the inner structure is deployed from the shaft and/or bent in various directions, as seen in Fig. 1. The Imran reference specifically discloses how the inner structure and the deformable shaft are bent in various desired directions until the portion of a tissue which is to be ablated is in close proximity to the inner electrode (pa. 0022).
Regarding claim 2, Imran discloses wherein the inner structure and the outer structure are coupled to the distal end of the shaft, and wherein the inner structure and the outer structure are each independently supported (pa. 0014, 0017 & Fig. 2).
Regarding claim 3, Imran discloses wherein the basket electrode assembly further comprises a central longitudinal axis and the inner structure is generally aligned with the central longitudinal axis in the expanded state (pa. 0022 & Fig. 1).
Examiner notes that the inner structure is aligned with the central longitudinal axis before it is bent.
Regarding claim 4, Imran discloses wherein at least a portion of the outer structure is configured to assume a planar shape in the expanded state (see Fig. 1).
Regarding claim 5, Imran discloses wherein the planar shape comprises a bowed planar shape, and wherein at least the portion of the outer structure bows radially outwardly from a central longitudinal axis (see Fig. 1).
Regarding claim 6, Imran discloses wherein the outer supporting body includes a plurality of outer supports (conductors 34 provided in a cable 36) (pa. 0016), and wherein each of the plurality of outer supports is tubular and includes:
the plurality of outer electrodes disposed thereon (pa. 0016); and
a plurality of conductors (34), each of the conductors extending from a corresponding one of the plurality of outer electrodes to a proximal end of the basket electrode assembly (pa. 0016).
Regarding claim 10, Imran discloses wherein the outer supporting body comprises a plurality of splines (see Fig. 1).
Regarding independent claim 11, Imran discloses an electrophysiology catheter (12) (pa. 0014 & Fig. 1), comprising:
an elongate, deformable shaft (combination of flexible elongated members 16 and 41) comprising a proximal end and a distal end (pa. 0014), wherein the shaft comprises a lumen (42, 21) (pa. 0014, 0017 & Fig. 2) ; and
a flexible electrode assembly (combination of expandable means 27, which comprises a plurality of flexible arms 28, and a distal extremity 56) coupled to the distal end of the shaft (pa. 0014, 0017), the flexible electrode assembly configured to assume a compressed state and an expanded state (pa. 0014, 0023), wherein the flexible electrode assembly comprises:
an expandable three-dimensional (3D) structure (28) comprising an outer supporting body (including conductors 34) and a plurality of outer electrodes (26) disposed thereon (pa. 0014, 0016 & Fig. 2),
an inner structure (56) comprising an inner supporting body (combination of conductor 51, insulating layer 52, and flexible elongate elements 63, 65, 67) and an inner electrode (54) located thereon (pa. 0017, 0020 & Figs. 2-3) and within an envelope defined by the expandable three-dimensional (3D) structure when the flexible electrode assembly is in the expanded state (see Figs. 1-2), wherein the inner electrode is spaced apart from the plurality of outer electrodes and configured to not contact tissue (i.e., in close proximity) when the flexible electrode assembly is in the expanded state (pa. 0022).
For further clarification, Examiner notes that the expanded state of the inner structure comprising an inner supporting body is when it is slidably positioned outside lumen (21) and/or when it is bent in various directions extending about 360° of the longitudinal axis of the catheter (pa. 0013, 0023).
Furthermore, regarding the claim limitation “wherein the inner electrode is … configured to not contact tissue when the basket electrode assembly is in the expanded state”, the expanded configuration of the basket electrode assembly is when the expandable (3D) structure bows outward and when the inner structure is deployed from the shaft and/or bent in various directions, as seen in Fig. 1. The Imran reference specifically discloses how the inner structure and the deformable shaft are bent in various desired directions until the portion of a tissue which is to be ablated is in close proximity to the inner electrode (pa. 0022).
Regarding claim 12, Imran discloses wherein the inner electrode comprises a non-contact mapping electrode for sensing an electrocardiogram (pa. 0017).
Regarding claim 20, Imran discloses wherein the outer supporting body of the expandable 3D structure comprises a plurality of splines (see Fig. 1).
Regarding claim 21, Imran discloses wherein the basket electrode assembly further comprises a plurality of wires (34), each wire coupled with a corresponding outer electrode of the plurality of outer electrodes (pa. 0016).
Regarding claim 22, Imran discloses wherein each wire is configured to electrically couple a corresponding outer electrode to a control unit (37) (pa. 0016).
Regarding claim 23, Imran discloses wherein the inner electrode is centrally positioned inside the envelope when the basket electrode assembly is in the expanded state (see Fig. 1).
Regarding claim 25, Imran discloses wherein at least a portion of the outer structure extends from the distal end of the shaft outwardly and away from the inner structure (see Fig. 1).
Regarding claim 26, Imran discloses wherein the basket electrode assembly further comprises a central longitudinal axis and the inner structure has a smaller radial distance from the central longitudinal axis than an outer structure radial distance from the central longitudinal axis (see Fig. 1).
Regarding claim 27, Imran discloses wherein the inner electrode comprises a non-contact mapping electrode for sensing an electrocardiogram (pa. 0017).
Regarding independent claim 29, Imran discloses an electrophysiology catheter (12) (pa. 0014 & Fig. 1), comprising:
an elongate, deformable shaft (combination of flexible elongated members 16 and 41) comprising a proximal end and a distal end (pa. 0014), wherein the shaft comprises a lumen (42, 21) (pa. 0014, 0017 & Fig. 2) ; and
a flexible electrode assembly (combination of expandable means 27, which comprises a plurality of flexible arms 28, and a distal extremity 56) coupled to the distal end of the shaft (pa. 0014, 0017), the flexible electrode assembly configured to assume a compressed state and an expanded state (pa. 0014, 0023), wherein the flexible electrode assembly comprises:
an expandable three-dimensional (3D) structure (28) comprising an outer supporting body (including conductors 34) and a plurality of outer electrodes (26) disposed thereon (pa. 0014, 0016 & Fig. 2),
an inner structure (56) comprising an inner supporting body (combination of conductor 51, insulating layer 52, and flexible elongate elements 63, 65, 67) and an inner electrode (54) located thereon (pa. 0017, 0020 & Figs. 2-3) and within a spherical envelope defined by the expandable three-dimensional (3D) structure (see Figs. 1-2), wherein the inner electrode is centrally positioned inside the envelope and spaced apart from the plurality of outer electrodes when the flexible electrode assembly is in the expanded state (see Fig. 1), wherein the flexible electrode assembly further comprises a central longitudinal axis and the inner structure has a smaller radial distance from the central longitudinal axis than an expandable 3D structure radial distance from the central longitudinal axis so that at least a portion of the expandable 3D structure extends outwardly and away from the inner structure (see Fig. 1).
For further clarification, Examiner notes that the expanded state of the inner structure comprising an inner supporting body is when it is slidably positioned outside lumen (21) and/or when it is bent in various directions extending about 360° of the longitudinal axis of the catheter (pa. 0013, 0023).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-9, 18-19, and 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Imran as applied to claims 1 and 11 above, and further in view of Dimmer (E.P. Application No. 2842510 B1).
Regarding claims 7-9, Imran discloses wherein at least a portion of the outer structure is configured to assume a planar shape (see Fig. 1).
However, Imran does not disclose wherein at least a portion of the outer structure is configured to assume a non-planar shape, wherein the non-planar shape comprises a twisted shape, wherein the twisted shape comprises a helical shape.
Dimmer, in the same field of endeavor, teaches an ablation assembly (700) comprising a plurality of electrodes (715a-h) arranged along a helical conduit (731) (analogous to the outer structure of Imran) (pa. 0115-0116 & Fig. 25).
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 shape of the outer structure of Imran to be a twisted, helical shape, taught by Dimmer, for the purpose of creating lesion patterns that are circumferentially offset from one another (Dimmer, pa. 0116).
Regarding claim 18, Imran discloses wherein the inner structure assumes a planar shape bowed radially outwardly from a central longitudinal axis in the expanded state (see Fig. 1).
However, Imran does not disclose wherein the expandable 3D structure assumes a helical shape with a helical pitch in the expanded state.
Dimmer, in the same field of endeavor, teaches an ablation assembly (700) comprising a plurality of electrodes (715a-h) arranged along a helical conduit (731) (analogous to the outer structure of Imran) (pa. 0115-0116 & Fig. 25).
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 shape of the expandable 3D structure of Imran to be a helical shape with a helical pitch in the expanded state as taught by Dimmer, for the purpose of creating lesion patterns that are circumferentially offset from one another (Dimmer, pa. 0116).
Regarding claim 19, Imran discloses the invention substantially as claimed in claim 11 discussed above.
However, Imran does not disclose wherein at least one of the expandable 3D structure and the inner structure assumes a helical shape in the expanded state.
Dimmer, in the same field of endeavor, teaches an ablation assembly (700) comprising a plurality of electrodes (715a-h) arranged along a helical conduit (731) (analogous to the outer structure of Imran) (pa. 0115-0116 & Fig. 25).
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 shape of the expandable 3D structure of Imran to be a helical shape in the expanded state as taught by Dimmer, for the purpose of creating lesion patterns that are circumferentially offset from one another (Dimmer, pa. 0116).
Furthermore, Examiner emphasizes that the claim language only requires at least one of the expandable 3D structure or the inner structure to assume a helical shape in the expanded state.
Regarding claim 24, Imran discloses the electrophysiology catheter (12) includes a plurality of longitudinally and radially spaced apart outer electrodes (26) (pa. 0014).
However, Imran does not disclose wherein the plurality of outer electrodes are evenly spaced from one another along the outer structure.
Dimmer, in the same field of endeavor, teaches one or more electrodes can be evenly or unevenly spaced about the circumference of an external structure (pa. 0092).
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 spacing of the outer electrodes along the outer structure to be evenly spaced, as taught by Dimmer, since it seems the invention would function equally as well either design choice and either embodiment (i.e., even or unevenly spaced) would yield the same predictable results of providing treatment to a targeted area.
Claims 13-15, 17, and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Imran as applied to claim 11 above, in view of Werneth (U.S. Patent No. 8617152 B2), and further in view of Dimmer (E.P. Application No. 2842510 B1).
Regarding claims 13-14, Imran discloses the outer electrodes on the expandable 3D structure are configured to map various potentials within the wall forming the cavity of the heart (pa. 0021).
However, Imran does not disclose wherein the expandable 3D structure is configured to provide ablation therapy.
Werneth, in the same field of endeavor, teaches an ablation catheter (100) comprising a carrier assembly (120) with a plurality of electrode (130), wherein the electrodes are electrically coupled to an RF delivery unit (200). The RF delivery unit is configured to deliver one or more types of energy, in variable and/or modulated forms, and preferably also configured to provide electrical mapping of the tissue that is contacted by one or more electrodes integral to carrier assembly. This dual mapping and ablation technique is utilized in order to confirm a proper location of the electrodes before applying the RF energy to the tissue.
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 functionality of the outer electrodes of Imran in order to be able to function as both mapping and ablation electrodes, as taught by Werneth, for the purpose of confirming proper location of the electrodes before applying the RF energy to the tissue.
However, Imran/Werneth combination do not disclose wherein the lumen comprises a fluid lumen, wherein the fluid lumen is centrally located in the shaft.
Dimmer, in the same field of endeavor, teaches an ablation assembly (400) that comprises an expandable basket (414) and electrodes (413, 415). The basket includes hollow members through which coolant flows to cool the electrodes (pa. 0096 & Fig. 17). The fluid flows along lumens (427, 429) which extend through a shaft of the ablation assembly (pa. 0097), centrally located along a radial axis of the shaft, as seen in Fig. 18.
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 centrally positioned fluid lumens of Dimmer to the electrophysiology catheter of Imran in order to cool the outer electrodes when they are providing ablation energy to the tissue.
Regarding claim 15, Imran/Werneth/Dimmer combination discloses wherein the inner electrode is centrally positioned inside the expandable 3D structure (Imran, see Fig. 1).
Regarding claim 17, Imran/Werneth/Dimmer combination discloses wherein the expandable 3D structure and the inner structure are coupled to the distal end of the shaft, and wherein the expandable 3D structure and the inner structure are each independently supported (Imran, pa. 0014, 0017 & Fig. 2).
Regarding claim 28, Imran discloses the electrophysiology catheter (12) includes a plurality of longitudinally and radially spaced apart outer electrodes (26) (pa. 0014).
However, Imran does not disclose wherein the plurality of outer electrodes are evenly spaced from one another along the expandable 3D structure.
Dimmer, in the same field of endeavor, teaches one or more electrodes can be evenly or unevenly spaced about the circumference of an external structure (pa. 0092).
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 spacing of the outer electrodes along the expandable 3D structure to be evenly spaced, as taught by Dimmer, since it seems the invention would function equally as well either design choice and either embodiment (i.e., even or unevenly spaced) would yield the same predictable results of providing treatment to a targeted area.
Claims 30-31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Imran as applied to claim 29 above, and further in view of Werneth (U.S. Patent No. 8617152 B2).
Regarding claim 30, Imran discloses the outer electrodes on the expandable 3D structure are configured to map various potentials within the wall forming the cavity of the heart (pa. 0021).
However, Imran does not disclose wherein the expandable 3D structure is configured to provide ablation therapy.
Werneth, in the same field of endeavor, teaches an ablation catheter (100) comprising a carrier assembly (120) with a plurality of electrode (130), wherein the electrodes are electrically coupled to an RF delivery unit (200). The RF delivery unit is configured to deliver one or more types of energy, in variable and/or modulated forms, and preferably also configured to provide electrical mapping of the tissue that is contacted by one or more electrodes integral to carrier assembly. This dual mapping and ablation technique is utilized in order to confirm a proper location of the electrodes before applying the RF energy to the tissue.
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 functionality of the outer electrodes of Imran in order to be able to function as both mapping and ablation electrodes, as taught by Werneth, for the purpose of confirming proper location of the electrodes before applying the RF energy to the tissue.
Regarding claim 31, Imran/Werneth combination discloses wherein the inner electrode comprises a non-contact mapping electrode (Imran, pa. 0017).
Response to Arguments
Applicant’s arguments on Appeal Brief filed 05/12/2026, with respect to the 102 rejection of claims 1, 11, and 29 under Werneth have been fully considered and are persuasive. 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 1-6, 10-12, 20-23, 25-27, and 29 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Imran (E.P. Application No. 0573311 B1).
It is the Examiner’s position that the newly filed rejection based on the Imran reference is tenable for at least the reasoning set forth in the action above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
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/A.V.G./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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