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 August 28, 2025 have been entered. All Double Patenting rejections have been overcome by the amendments. Currently, claims 1, 3-5, 10, 15, 17-18, 20 have been amended, claim 6 has been cancelled, claim 21 has been newly added, and claim 1-5, 7-21 are pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the single resilient wire formed by a first and a second wire joined together must be shown or the feature(s) canceled from the claim(s). Specifically, Examiner would like to draw attention to paragraph [0038] of the filed Specification which describes a first embodiment in which the resilient frame assembly comprises a first wire and a second wire, while a second embodiment describes the resilient frame comprising a single piece of wire. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 5, the claim requires that the resilient frame comprises “a first and a second wire joined together”, while the parent claim 4 sets forth that the resilient frame comprises “a single resilient wire”.
The Examiner has reviewed the instant disclosure and has identified a recitation of the manufacturing method of the resilient frame assembly. Specifically, paragraph [0038] of the filed Specification provides the “resilient frame assembly (310) includes a first wire (320) and a second wire (330) … In some other versions, resilient frame assembly (310) is formed by a single piece of wire such that union sleeve (312) is omitted”. The resilient frame assembly, as described in the Specification, is either a frame constructed by first wire and a second wire joined together by a union sleeve, or is a single piece of wire.
Thus, it is the Examiner’s position that the requirement of claims 4-5 of the resilient wire frame comprising a single wire and comprising a first wire and a second wire joined together has no support since this was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA U.S.C. 112, the inventor(s), at the time the application was filed, had passion of the claimed invention given that the disclosure specifically provides for two separate embodiments of the resilient wire frame. Appropriate correction is required.
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 5 and 21 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.
Regarding claim 5, the claim requires that the resilient frame comprises “a first and a second wire joined together”. Parent claim 4 sets forth that the resilient frame comprises “a single resilient wire”. The Examiner is of the position that the scope of claim 5 is indefinite because it is unclear how the first and second wire in claim 5 are structurally and/or functionally related to the single resilient wire of claim 4. It appears, as claim 5 is presently drafted, that the requirements in claims 4 and 5 conflict with one another with respect to the construction of the resilient frame and the lack of relationship in each claim of the wires to one another leaves question as to the resultant structure required by the combination of limitations per claim 5. For the purpose of examination, the Examiner will be interpreting the resilient frame to either require single wire construction (per claim 4) or first/second joined wire construction (per claim 5. Appropriate correction is required.
Claim 21 recites the limitation "the second flexible substrate" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Specifically, the parent claim 1 only introduces a first flexible substrate thereby failing to provide a proper basis for the at-issue limitation in claim 21. The Examiner is of the position that the lack of antecedent basis renders the scope of the claim as indefinite since it is unclear, at the very least, if the second flexible substrate is included as additional structure of the first flex circuit assembly in claim 1, or if such is included as other structure in additional to the first flex circuit assembly. Appropriate correction is required.
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 1-5, 8, 10-11, 13, 15-21 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 & 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 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 as seen in Fig. 1A), 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, 276-3, 276-4) 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(s) comprising a plurality of curves and bends created by the resilient wire frame), 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), the first flex circuit assembly comprising:
(A) a first flexible substrate (i.e., a dielectric layer formed on top of the resilient frame) (pa. 0077), comprising 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 above) on the resilient wire frame and separated along a first perimeter (i.e., top inner and top outer loop perimeter formed by the resilient frame) of the first flexible substrate, the first flexible substrate further comprising a first inner structure (i.e., outer/top surface of the flexible substrate that is disposed on a top half of the resilient wire frame, pa. 0075) disposed within the distal loop and attached to the resilient frame 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 permanently 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, 276-2, 276-3, 276-4 to be the resilient wire frame since it’s a metal drawn out into the form of a thin flexible thread or rod.
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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 5, Voth discloses the resilient wire frame comprising a first structure (276-1, 276-2) and a second structure (276-3, 276-4) joined together (i.e., each respective first structure joined to each respective complementary second structure at a distal end, 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 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 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) 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) (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) 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, 276-3, 276-4, 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(s) comprising a plurality of curves and bends created by the resilient wire frame), 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 (i.e., body 220 formed by a plurality of inner members 242, pa. 0052) secured to the resilient wire frame (pa. 0041), the flex circuit assembly comprising:
(A) a resilient substrate (i.e., a dielectric layer formed on top of the resilient frame) (pa. 0077), comprising a plurality of perimeter point connections (see annotated Fig. 7A below) overlaid on the resilient wire frame and separated along a perimeter of the resilient substrate, the resilient substrate 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, pa. 0075) disposed within the distal loop and attached to the resilient wire frame 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).
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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 permanently securing/fixedly attaching the perimeter point connections near an intersection of two extending portions that comprise the resilient flat 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, 276-2, 276-3, 276-4 to be the resilient wire frame since it’s a metal drawn out into the form of a thin flexible thread or rod.
Regarding claim 19, Voth discloses the resilient substrate being configured to bias the flex circuit assembly toward a flat configuration (pa. 0031).
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 & 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, 276-3, 276-4, 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(s) comprising a plurality of curves and bends created by the resilient wire frame), defining a closed perimeter 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 on the resilient wire frame and separated along a perimeter (i.e., top inner and top outer loop perimeter formed by the resilient frame) of the generally planar flex circuit assembly, 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, pa. 0075) disposed inside the closed perimeter and secured to the resilient frame by the plurality of separated perimeter point attachments (pa. 0077), 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 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 permanently 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, 276-2, 276-3, 276-4 to be the resilient wire frame since it’s a metal drawn out into the form of a thin flexible thread or rod.
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Regarding claim 21, Voth discloses wherein the second flexible substrate (i.e., a dielectric layer formed on the bottom half of the resilient frame) (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, see annotated Fig. 7A on page 5 of the Office Action) overlaid on the resilient wire frame and separated along a perimeter of 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 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., to 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.
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).
Response to Arguments
Applicant's arguments filed 08/28/2025 have been fully considered and they are persuasive. Specifically, Applicant’s arguments regarding the newly amended language of the apparatus including a resilient wire frame. Therefore, the prior rejections based on Fuentes-Ortega have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-5, 8, 10-11, 13, 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voth (W.O. Application No. 2019195439 A1).
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).
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).
It is the Examiner’s position that the newly filed rejections based on Voth 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.
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 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794