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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/13/2026 has been entered.
Response to Amendment
The Amendments filed May 13, 2026 have been entered. Applicant’s amendments to the claims have overcome the Drawing objection, 112(a) rejection, and 112(b) rejection previously set-forth in the Final Office Action mailed on 11/13/2025. Currently, claims 1, 5, 18, 20-21 have been amended, and claims 1-5, 7-21 are pending in the application.
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.
Claims 10-12 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the first flexible substrate" in line 1. There is insufficient antecedent basis for this limitation in the claim. Since this limitation has been deleted from independent claim 1, Examiner will treat the first flexible substrate as further requiring a first inner structure in order to expedite prosecution. Claims 11-12 are also rejected because they are dependent on claim 10.
Claims 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the one or more elongation features comprising one or more serpentine curves or one or more zig-zag structures.
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 1-4, 8, 10-11, 13, 15-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voth (W.O. Application No. 2019195439 A1).
Regarding independent claim 1, Voth discloses an apparatus comprising:
(a) a catheter shaft assembly (107) having a proximal end and a distal end (pa. 0031), the catheter shaft assembly defining a longitudinal axis (aa) (pa. 0031); and
(b) an end effector (270) (pa. 0075 & Fig. 7A) associated with the distal end of the catheter shaft assembly, the end effector being configured to transition between a first configuration (i.e., a retracted state inside a delivery catheter/introducer) (pa. 0032) and a second configuration (i.e., an expanded state), the end effector being configured to fit within an outer sheath in the first configuration, the end effector being configured to expand outwardly away from the longitudinal axis in the second configuration when exposed distally relative to the distal end of the outer sheath (pa. 0032), the end effector comprising:
(i) a resilient wire frame (276-1, 276-2) extending distally from the catheter shaft assembly (pa. 0076, 0082) and comprising first and second proximal ends (see annotated Fig. 7A below) and a distal loop (i.e., a continuous shape comprising a plurality of curves and bends created by the resilient wire frame) defining an open region free of the resilient wire frame (see Fig. 7A), the first and second proximal ends of the resilient wire frame being fixedly attached to the distal end of the catheter shaft assembly (via a connector 108, pa. 0031), the resilient wire frame being configured to resiliently bias the end effector toward the second configuration (pa. 0032), and
(ii) a first flex circuit assembly (274-1, 274-2, 274-3, 274-4) secured to the resilient wire frame (pa. 0075) (at least flex circuits 274-1, 274-4), the first flex circuit assembly comprising:
(A) a first flexible substrate (i.e., a dielectric layer formed on top of the resilient frame and wires 276-3, 276-4) (pa. 0077) comprising a main portion (at least a first main portion comprising a structure of the dielectric layer of the flex circuits 274-1, 274-2 and a second main portion comprising the structure of the dielectric layer of the flex circuits 274-3, 274-4) and a plurality of first perimeter point connections (see annotated Fig. 7A below) overlaid (i.e., the dielectric layer is placed on top of the resilient frame as described below) on the resilient wire frame and separated along a first perimeter of the first flexible substrate, the main portion spanning across the open region (at least the flex circuit 274-2 of the first main portion and the flex circuit 274-3 of the second main portion) and attached to the resilient frame (at least the flex circuit 274-1 of the first main portion and the flex circuit 274-4 of the second main portion) by the plurality of separated first perimeter point connections, and
(B) a plurality of first electrodes (272-1, 272-2, ... , 274-16) positioned on the first flexible substrate (pa. 0075), the first electrodes being configured perform one or both of:
(1) picking up electrical potentials from tissue or blood (pa. 0030), or
(2) ablating tissue (pa. 0033).
Examiner is interpreting the word ‘overlaid’ as covering the surface of a structure. In the scenario, the resilient wire frame is a nitinol structure that is interposed between layers of the flexible material which forms the first flex circuit assembly (pa. 0082). Furthermore, Examiner is interpreting the attachment of the first flexible substrate to the resilient wire frame via the first perimeter point connections as any means of securing/fixedly attaching the perimeter point connections near an intersection of two extending portions that comprise the resilient wire frame, as described in the Specification of the instant application [pa. 0041]. Lastly, Examiner is interpreting the nitinol material that comprises the structures 276-1 and 276-2 to be the resilient wire frame since it’s a metal drawn out into the form of a thin flexible thread or rod.
With regards to the claim limitation of “a distal loop defining an open region free of the resilient wire frame”, Examiner highlights that the claim language is broad and only requires the open region to be free of, or not enclose, any portions of the resilient wire frame. Since only the outermost wires (276-1, 276-2) of the end effector are mapped as the resilient wire frame, the innermost wires (276-3, 276-4) located inside the open region are not considered to be part of the resilient wire frame and therefore this new interpretation of the Voth reference meets the claim limitation.
Furthermore, with regards to the claim limitation of “a first flexible substrate comprising a main portion…the main portion spanning across the open region and attached to the resilient wire frame by the plurality of separated first perimeter point connections”, Examiner is interpreting the main portion as comprising at least one main portion given that the claim language is broad and does not restrict/specify the number of main portions that can exist in the first flexible substrate. Given the absent use of the term “main portion” in the filed Specifications, Examiner will further interpret the main portion as a structure of the dielectric layer of the flex circuit assembly.
PNG
media_image1.png
468
1257
media_image1.png
Greyscale
Regarding claim 2, Voth discloses the end effector being configured to define a flat, planar shape in the second configuration (pa. 0031).
Regarding claim 3, Voth discloses the resilient wire frame comprising nitinol (pa. 0032).
Regarding claim 4, Voth discloses the resilient wire frame comprising a single resilient structure (i.e., each of the two distal loops created by the frame comprise a single continuous resilient structure, as seen in Fig. 7A).
Regarding claim 8, Voth discloses the first flexible substrate comprising an extensible material/flexible material (pa. 0032).
Regarding claim 10, Voth discloses the first inner structure (i.e., outer/top surface of the flexible substrate that is disposed on a top half of the resilient wire frame and the wires 276-3, 276-4) of the first flexible substrate comprising one or more elongation features (see Fig. 7A).
Regarding claim 11, Voth discloses the one or more elongation features comprising one or more serpentine curves (i.e., curves seen in the proximal end of the resilient wire frame and the wires 276-3, 276-4 where the flexible circuit extend over, pa. 0076 & Fig. 7A).
Regarding claim 13, Voth discloses the first flexible substrate comprising nitinol (pa. 0032).
Regarding claim 15, Voth discloses the end effector further comprising a second flex circuit assembly (i.e., 274-1, 274-2, 274-3, 274-4 located on the bottom side of the resilient frame and the wires 276-3, 276-4) secured to the resilient wire frame (pa. 0075), the second flex circuit assembly comprising:
(A) a second flexible substrate (i.e., a dielectric layer formed on the bottom side of the resilient frame and the wires 276-3, 276-4) (pa. 0077), and
(B) a plurality of second electrodes (i.e., 272-1, 272-2, ... , 274-16 located on the bottom side of the resilient frame and the wires 276-3, 276-4) positioned on the second flexible substrate (pa. 0075), the second electrodes being configured perform one or both of:
(1) picking up electrical potentials from tissue or blood (pa. 0030), or
(2) ablating tissue (pa. 0033).
Regarding claim 16, Voth discloses the first flex circuit assembly being positioned on a first side (i.e., top side) of the end effector, the second flex circuit assembly being positioned on a second side (i.e., bottom side) of the end effector, the second side being opposite to the first side (pa. 0075).
Regarding claim 17, Voth discloses the end effector further comprising a plurality of second electrodes, the first electrodes being positioned on a first side of the end effector, the second electrodes being positioned on a second side of the end effector, the second side being opposite to the first side (pa. 0075).
Regarding independent claim 18, Voth discloses an apparatus comprising:
(a) a catheter shaft assembly (107) having a proximal end and a distal end (pa. 0031 & Fig. 1A), the catheter shaft assembly defining a longitudinal axis (aa) (pa. 0031); and
(b) an end effector (270) (pa. 0075 & Fig. 7A) associated with the distal end of the catheter shaft assembly, the end effector comprising:
(i) a resilient wire frame (276-1, 276-2, pa. 0082), extending distally from the catheter shaft assembly (pa. 0033 & Fig. 2B) and comprising first and second proximal ends (see annotated Fig. 7A below) and a distal loop (i.e., a continuous shape comprising a plurality of curves and bends created by the resilient wire frame) defining an open region free of the resilient wire frame (see Fig. 7A), the first and second proximal ends of the resilient wire frame being fixedly attached to the distal end of the catheter shaft assembly (via a connector 108, pa. 0031), the resilient wire frame being configured to resiliently bias the end effector toward an expanded configuration (pa. 0022), and
(ii) a flex circuit assembly (274-1, 274-2, 274-3, 274-4) secured to the resilient wire frame (pa. 0075) (at least flex circuits 274-1, 274-4), the flex circuit assembly comprising:
(A) a resilient substrate (i.e., a dielectric layer formed on top of the resilient frame and wires 276-3, 276-4) (pa. 0077) comprising a main portion (at least a first main portion comprising a structure of the dielectric layer of the flex circuits 274-1, 274-2 and a second main portion comprising the structure of the dielectric layer of the flex circuits 274-3, 274-4) and a plurality of perimeter point connections (see annotated Fig. 7A below) overlaid (i.e., the dielectric layer is placed on top of the resilient frame as described below) on the resilient wire frame and separated along a perimeter of the resilient substrate, the main portion spanning across the open region (at least the flex circuit 274-2 of the first main portion and the flex circuit 274-3 of the second main portion) within the distal loop and attached to the resilient wire frame (at least the flex circuit 274-1 of the first main portion and the flex circuit 274-4 of the second main portion) by the plurality of separated perimeter point connections, and
(B) a plurality of electrodes (272-1, 272-2, ... , 274-16) positioned on the resilient substrate (pa. 0075), the plurality of electrodes being configured to perform one or both of:
(1) picking up electrical potentials from tissue or blood (pa. 0030), or
(2) ablating tissue (pa. 0033).
Examiner is interpreting the word ‘overlaid’ as covering the surface of a structure. In the scenario, the resilient wire frame is a nitinol structure that is interposed between layers of the flexible material which forms the first flex circuit assembly (pa. 0082). Furthermore, Examiner is interpreting the attachment of the first flexible substrate to the resilient wire frame via the first perimeter point connections as any means of securing/fixedly attaching the perimeter point connections near an intersection of two extending portions that comprise the resilient wire frame, as described in the Specification of the instant application [pa. 0041]. Lastly, Examiner is interpreting the nitinol material that comprises the structures 276-1 and 276-2 to be the resilient wire frame since it’s a metal drawn out into the form of a thin flexible thread or rod.
With regards to the claim limitation of “a distal loop defining an open region free of the resilient wire frame”, Examiner highlights that the claim language is broad and only requires the open region to be free of, or not enclose, any portions of the resilient wire frame. Since only the outermost wires (276-1, 276-2) of the end effector are mapped as the resilient wire frame, the innermost wires (276-3, 276-4) located inside the open region are not considered to be part of the resilient wire frame and therefore this new interpretation of the Voth reference meets the claim limitation.
Furthermore, with regards to the claim limitation of “a first flexible substrate comprising a main portion…the main portion spanning across the open region and attached to the resilient wire frame by the plurality of separated first perimeter point connections”, Examiner is interpreting the main portion as comprising at least one main portion given that the claim language is broad and does not restrict/specify the number of main portions that can exist in the first flexible substrate. Given the absent use of the term “main portion” in the filed Specification, Examiner will further interpret the main portion as a structure of the
PNG
media_image2.png
468
1257
media_image2.png
Greyscale
dielectric layer of the flex circuit assembly.
Regarding claim 19, Voth discloses the resilient substrate being configured to bias the flex circuit assembly toward a flat configuration (pa. 0031).
Regarding claim 21, Voth discloses wherein a second flexible substrate (i.e., a dielectric layer formed on the bottom half of the resilient frame and the wires 276-3, 276-4) (pa. 0077) comprises a plurality of second perimeter point connections (i.e., point connections located in the same area as the first perimeter point connection, but on opposite sides) overlaid on the resilient wire frame (at least the flex circuit 274-1 of the first main portion and the flex circuit 274-4 of the second main portion, but on opposite sides) and separated along a perimeter of the second flexible substrate, the second flexible substrate further comprising a second inner structure (i.e., surface directly opposite of the first inner surface) disposed within the distal loop (at least the flex circuit 274-2 of the first main portion and the flex circuit 274-3 of the second main portion, but on opposite sides) and attached to the resilient wire flat frame by the plurality of separated second perimeter point connection, the first flexible substrate on a first side (i.e., top half) of the resilient wire frame and the second flexible substrate on a second side (i.e., bottom half) of the resilient wire frame (pa. 0075).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being obvious over Voth as applied to claim 1 above, and further in view of a second embodiment of Voth.
Regarding claim 5, Voth discloses the resilient wire frame comprising a single resilient wire.
However, this first embodiment does not disclose a first wire and a second wire joined together.
A second embodiment of Voth as seen in Fig. 1B, the end effector of the apparatus contains an additional perimeter point connection, labeled as 109 on the figure, which helps connects, or join, the first wire (106; analogous to the resilient wire frame 276-1 from the first embodiment) to the second wire (103; analogous to the resilient wire frame 276-2 from the first embodiment).
Examiner notes that the claim language is broad and does not specify that the first wire and the second wire need to be separated prior to joining them together. Therefore, this interpretation of the prior art meets the claim limitation.
Therefore, 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 additional perimeter point connection taught by the secondary embodiment of Voth to the primary embodiment in order to join the first and second wire that comprise the resilient wire frame since it seems the apparatus would operate equally as well with either design choice and they would both yield the same predictable results of providing a catheter shaft with an end effector configured to ablate tissue.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being obvious over Voth as applied to claim 1 above, and further in view of Fuentes-Ortega (W.O. Application No. 2021011289 A1).
Regarding claims 7 and 9, Voth discloses the first flexible substrate comprising a dielectric material.
However, Voth does not disclose the first flexible substrate comprising a resilient/ non-extensible material.
Fuentes-Ortega, in the same field of endeavor, teaches a flexible substrate comprising a resilient/ non-extensible material (e.g., polyimide, polyether ether ketone, etc.) (pa. 0041).
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 dielectric material of the flexible substrate of Voth for the dielectric resilient material of Fuentes-Ortega since they are both known equivalents in the art and they would yield the same predictable results of providing a flexible and resilient substrate structure where a plurality of electrodes can be mounted on.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being obvious over Voth as applied to claim 1 above, and further in view of Gwerder (E.P. Application No. 2789301 B1).
Regarding claim 12, Voth discloses the invention substantially as claimed in claims 1 and 10 discussed above.
However, Voth does not disclose the one or more elongation features comprising one or more zig-zag structures.
Gwerder, in the same field of endeavor, teaches a catheter assembly comprising an end effector, the end effector further comprising splines (1610) (analogous to the elongation features) and voids (1615) (pa. 0121 & Fig. 11A). The splines can include a variety of patterns, such as multiples jagged shapes (1610-c-3) (i.e., zig-zag structures) (pa. 0133 & Fig. 13D).
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 elongation features to include a zig-zag shape for the purpose of influencing the bending strength or rigidity of the end effector (Gwerder, pa. 0116).
Regarding claim 14, Voth discloses the invention substantially as claimed in claim 1 discussed above.
However, Voth does not disclose the first flexible substrate comprising silicone.
Gwerder, in the same field of endeavor, teaches an end effector comprising an elastomeric material such as silicone (pa. 00107, 0119-0120).
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 included silicone material in the flexible substrate of Voth for the purpose of further providing the end effector with the ability to transition between a collapsed configuration and an expanded configuration (Gwerder, pa. 0107).
Claim 20 is rejected under 35 U.S.C. 103 as being obvious over Voth (W.O. Application No. 2019195439 A1), and further in view of a second embodiment of Voth.
Regarding independent claim 20, Voth discloses an apparatus comprising:
(a) a catheter shaft assembly (107) having a proximal end and a distal end (pa. 0031), the catheter shaft assembly defining a longitudinal axis (pa. 0031); and
(b) an end effector (270) (pa. 0075 & Fig. 7A) associated with the distal end of the catheter shaft assembly, the end effector comprising:
(i) a resilient wire frame (276-1, 276-2, pa. 0082) extending from the catheter shaft assembly and comprising first and second proximal ends (see annotated Fig. 7A below) and a distal loop (i.e., a continuous shape comprising a plurality of curves and bends created by the resilient wire frame) defining a closed perimeter surrounding an open region free of the resilient wire frame (see Fig. 7A), with the distal end of the catheter shaft assembly bounded by the distal loop (see Fig. 7A), the first and second proximal ends of the resilient frame being fixedly attached to the distal end of the catheter shaft assembly (via a connector 108, pa. 0031), the resilient wire frame being configured to resiliently bias the end effector toward a flat, expanded configuration (pa. 0031-0032), and
(ii) a generally planar flex circuit assembly (274-1, 274-2, 274-3, 274-4) comprising a plurality of perimeter point connections (see annotated Fig. 7A below) overlaid (i.e., the dielectric layer is placed on top of the resilient frame as described below) on the resilient wire frame and separated along a perimeter of the generally planar flex circuit assembly (see Fig. 7A), the generally planar flex circuit assembly further comprising an inner structure (i.e., outer/top surface of the flexible substrate that is disposed on a top half of the resilient wire frame and wires 276-3, 276-4, pa. 0075) disposed in the open region (at least the flex circuit 274-2 and the flex circuit 274-3), the flex circuit assembly having electrodes disposed on both sides of the inner structure of the generally planar flex circuit assembly (pa. 0075).
Examiner is interpreting the word ‘overlaid’ as covering the surface of a structure. In the scenario, the resilient wire frame is a nitinol structure that is interposed between layers of the flexible material which forms the first flex circuit assembly (pa. 0082). Furthermore, Examiner is interpreting the attachment of the first flexible substrate to the resilient wire frame via the first perimeter point connections as any means of securing/fixedly attaching the perimeter point connections near an intersection of two extending portions that comprise the resilient wire frame, as described in the Specification of the instant application [pa. 0041]. Lastly, Examiner is interpreting the nitinol material that comprises the structures 276-1 and 276-2 to be the resilient wire frame since it’s a metal drawn out into the form of a thin flexible thread or rod.
PNG
media_image3.png
468
1257
media_image3.png
Greyscale
With regards to the claim limitation of “a distal loop defining a closed perimeter surrounding an open region free of the resilient wire frame”, Examiner highlights that the claim language is broad and only requires the open region to be free of, or not enclose, any portions of the resilient wire frame. Since only the outermost wires (276-1, 276-2) of the end effector are mapped as the resilient wire frame, the innermost wires (276-3, 276-4) located inside the open region are not considered to be part of the resilient wire frame and therefore this new interpretation of the Voth reference meets the claim limitation.
However, this first embodiment of Voth does not disclose the generally planar flex circuit assembly further comprising the inner structure suspended on the resilient frame by the plurality of separated perimeter point connections.
A second embodiment of Voth as seen in Fig. 1B, the end effector of the apparatus contains an additional perimeter point connection, labeled as 109 on the figure, which helps connects, or suspend, the wires (105, 104; analogous to wires 276-3, 276-4 from the first embodiment) to the resilient wire frame (106, 103; analogous to the resilient wire frame 276-1, 276-2 from the first embodiment).
Absent of the phrase “suspended on” being used in the filed Specification, Examiner will be interpreting the phrase being attached to something in order to hang freely in air.
Therefore, 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 additional perimeter point connection taught by the secondary embodiment of Voth to the primary embodiment in order to suspend the inner structure to the resilient wire frame since it seems the apparatus would operate equally as well with either design choice and they would both yield the same predictable results of providing a catheter shaft with an end effector configured to ablate tissue.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
With regards to newly amended claims 1 and 18, Applicant argues that none of the cited references discloses a resilient wire frame comprising first and second proximal ends and a distal loop defining an open region free of the resilient wire frame, and a main portion and a plurality of first perimeter point connections overlaid on the resilient wire frame and separated along a first perimeter of the first flexible substrate, the main portion spanning across the open region and attached to the resilient frame by the plurality of separated first perimeter point connections. However, Examiner, respectfully, disagrees.
A new interpretation of the Voth reference has been employed in order to reject the newly amended claim limitations. Using this new interpretation, a resilient wire frame is mapped to parts 276-1, 276-2, wherein the resilient wire frame comprises a distal loop (i.e., a continuous shape comprising a plurality of curves and bends created by the resilient wire frame) defining an open region free of the resilient wire frame (see Fig. 7A). A first flexible substrate (i.e., a dielectric layer formed on top of the resilient frame) (pa. 0077) comprises a main portion (at least a first main portion comprising a structure of the dielectric layer of the flex circuits 274-1, 274-2 and a second main portion comprising the structure of the dielectric layer of the flex circuits 274-3, 274-4) and a plurality of first perimeter point connections (see annotated Fig. 7A below the claims 1 and 18 rejections) overlaid (i.e., the dielectric layer is placed on top of the resilient frame as described above) on the resilient wire frame and separated along a first perimeter of the first flexible substrate, the main portion spanning across the open region (at least the flex circuit 274-2 of the first main portion and the flex circuit 274-3 of the second main portion) and attached to the resilient frame (at least the flex circuit 274-1 of the first main portion and the flex circuit 274-4 of the second main portion) by the plurality of separated first perimeter point connections.
With regards to the claim limitation of “a distal loop defining an open region free of the resilient wire frame”, Examiner highlights that the claim language is broad and only requires the open region to be free of, or not enclose, any portions of the resilient wire frame. Since only the outermost wires (276-1, 276-2) of the end effector are mapped as the resilient wire frame, the innermost wires (276-3, 276-4) located inside the open region are not considered to be part of the resilient wire frame and therefore this new interpretation of the Voth reference meets the claim limitation.
Furthermore, with regards to the claim limitation of “a first flexible substrate comprising a main portion…the main portion spanning across the open region and attached to the resilient wire frame by the plurality of separated first perimeter point connections”, Examiner is interpreting the main portion as comprising at least one main portion given that the claim language is broad and does not restrict/specify the number of main portions that can exist in the flexible substrate. Given the absent use of the term “main portion” in the filed Specification, Examiner will further interpret the main portion as a structure of the dielectric layer of the flex circuit assembly. Therefore, for the reasonings set-forth above, the rejection is maintained under this new interpretation of the Voth reference.
With regards to newly amended claim 20, Applicant argues that none of the cited references discloses an end effector comprising (i) a resilient wire frame extending from the catheter shaft assembly and comprising first and second proximal ends and a distal loop defining a closed perimeter surrounding an open region free of the resilient wire frame, and (ii) a generally planar flex circuit assembly comprising a plurality of perimeter point connections overlaid on the resilient wire frame and separated along a perimeter of the generally planar flex circuit assembly, the generally planar flex circuit assembly further comprising an inner structure disposed in the open region and suspended on the resilient frame by the plurality of separated perimeter point connections. However, Examiner disagrees.
A new interpretation of the Voth reference has been employed in order to reject the newly amended claim limitations. Using this new interpretation, a resilient wire frame is mapped to (276-1, 276-2, pa. 0082), wherein the resilient wire frame comprises a first and second proximal ends (see annotated Fig. 7A in the rejection of claim 20) and a distal loop (i.e., a continuous shape comprising a plurality of curves and bends created by the resilient wire frame) defining a closed perimeter surrounding an open region free of the resilient wire frame (see Fig. 7A).
Furthermore, a generally planar flex circuit assembly is mapped to (274-1, 274-2, 274-3, 274-4) comprising a plurality of perimeter point connections (see annotated Fig. 7A) overlaid (i.e., the dielectric layer is placed on top of the resilient frame) on the resilient wire frame and separated along a perimeter of the generally planar flex circuit assembly (see Fig. 7A), the generally planar flex circuit assembly further comprising an inner structure (i.e., outer/top surface of the flexible substrate that is disposed on a top half of the resilient wire frame and wires 276-3, 276-4, pa. 0075) disposed in the open region (at least the flex circuit 274-2 and the flex circuit 274-3).
However, this first embodiment of Voth does not disclose the generally planar flex circuit assembly further comprising the inner structure suspended on the resilient frame by the plurality of separated perimeter point connections.
A second embodiment of Voth as seen in Fig. 1B, the end effector of the apparatus contains an additional perimeter point connection, labeled as 109 on the figure, which helps connects, or suspend, the wires (105, 104; analogous to wires 276-3, 276-4 from the first embodiment) to the resilient wire frame (106, 103; analogous to the resilient wire frame 276-1, 276-2 from the first embodiment).
Absent of the phrase “suspended on” being used in the filed Specification, Examiner will be interpreting the phrase being attached to something in order to hang freely in air.
Therefore, 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 additional perimeter point connection taught by the secondary embodiment of Voth to the primary embodiment in order to suspend the inner structure to the resilient wire frame since it seems the apparatus would operate equally as well with either design choice and they would both yield the same predictable results of providing a catheter shaft with an end effector configured to ablate tissue. Therefore, for the reasonings set-forth above, the rejection is maintained under this new interpretation of the Voth reference using a combination of different embodiments.
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.
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, Joseph Stoklosa can be reached at (571) 272-1213. 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.
/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
Prosecution Insights