DETAILED ACTION
Applicant's amendments and remarks, filed 3/20/26, are fully acknowledged by the Examiner. Currently, claims 1-20 are pending with claims 1, 10, and 11 amended. The following is a complete response to the 3/20/26 communication.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 4-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guo (US 2016/0317220).
Regarding claim 1, Guo teaches a catheter comprising: a corrugated strut (15) extending along a longitudinal axis (15 extending along axis X as in Fig. 5) and comprising undulations with an amplitude in a first orthogonal axis orthogonal to the longitudinal axis (Fig. 5 and par. [0038], with undulations radially outwards), the undulation giving the corrugated strut a lateral stiffness in a second orthogonal axis orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis (different stiffness levels as in par. [0030]), and an axial stiffness in the first orthogonal axis, the lateral stiffness being greater than the axial stiffness (par. [0030] lowest stiffness as a sweeping plane); an electrically insulating structure disposed around at least a portion of the corrugated strut and comprising a width greater than the amplitude of the undulations (insulating structure 211 with a width greater than the amplitude of the undulations as in Fig. 5), the width being measured along a second orthogonal axis orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis (as in at least Figs. 4a-5); and one or more electrodes coupled to the electrically insulating structure (electrodes 13 on 211).
Regarding claim 4, Guo teaches the amplitude of the undulations defining a gap along the first
orthogonal axis such that the one or more electrodes are primarily disposed outside of the gap (13 outside the gap formed by the undulations 40 forming gaps 41).
Regarding claim 5, Guo teaches a wavelength of the undulations varying along a length of the corrugated strut (Fig. 11).
Regarding claim 6, Guo teaches the catheter further comprising: a shaft extending along the longitudinal axis (shaft 10 as in Fig. 4a); and an end effector disposed at a distal end of the shaft (end effector depicted in Fig. 4a), the end effector comprising the corrugated strut, the electrically insulating structure, and the one or more electrodes (Fig. 4a).
Regarding claim 7, Guo teaches the catheter further comprising:
a linear spine comprising the corrugated strut, the electrically insulating structure, and the one or more electrodes (linear spine as in Fig. 4a), the one or more electrodes comprising a ring electrode encircling the electrically insulating structure (13 is a ring electrode as in at least Fig. 4b), and the ring electrode comprising an inner diameter greater than the amplitude of the undulations (13 with an inner diameter greater than the undulations as in Fig. 5).
Regarding claim 8, Guo teaches the electrically insulating structure of the linear spine comprising an elongated member with a lumen therethrough such that at least a portion of the corrugated strut extends through the lumen (211 as an elongated member with a lumen for the corrugated strut 15) and the width of the elongated member through which the corrugated strut extends is greater than the amplitude of the undulations of the portion of the corrugated strut within the lumen (Fig. 5, undulation amplitude less than the width of the elongated member).
Regarding claim 9, Guo teaches the electrically insulating structure comprising a pair of planar membranes orthogonal to the first orthogonal axis such that the corrugated strut is positioned between the pair of planar membranes (16).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of Tobey (US 2020/0038101).
Regarding claim 2, Guo teaches further comprising: a plurality of corrugated struts (14 and 15), each extending along the longitudinal axis and each comprising undulations in the first orthogonal axis (40 and 41); one or more electrically insulating structures disposed around the plurality of corrugated struts (211).
Guo teaches one or more energy emitting elements such as electrodes as common energy emitting elements of these catheters (par. [0002]), but is not explicit regarding an array of electrodes disposed on the one or more electrically insulating structures.
However, Tobey teaches catheter structures with an array of electrodes (132 as in par. [0047]).
It would have been obvious to one of ordinary skill in the art to modify Guo with an electrode array as in Tobey rather than a singular electrode, allowing for sensing in various configurations (par. [0047]).
Regarding claim 3, Guo is not explicit regarding the array of electrodes.
However, Tobey teaches the array of electrodes as in claim 2.
In the combination, the array of electrodes would be arranged in a plane orthogonal to the first orthogonal axis, as the electrodes would be on a different longitudinal position of the catheter than the undulations.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guo in view of De La Rama (US 2014/0200639).
Regarding claim 10, Guo teaches a catheter comprising:
A corrugated strut extending along a longitudinal axis (corrugated layer 15 as in at least Fig. 5) and comprising undulations with an amplitude in a first orthogonal axis orthogonal to the longitudinal axis (undulations as in par. [0050] an Fig. 5);an electrically insulating structure disposed around at least a portion of the corrugated strut (insulated layer 14) and comprising a width greater than the amplitude of the undulations (Fig. 6a), the width being measured along a second orthogonal axis orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis (14 with a width longer than 15); andone or more electrodes coupled to the electrically insulating structure (electrodes 13), the electrically insulating structure comprising a pair of planar membranes orthogonal to the first orthogonal axis such that the corrugated strut is positioned between the pair of planar membranes (stiffening elements 16 as in par. [0045]).
Guo is silent regarding the one or more electrodes comprising a pair of electrodes positioned opposite each other on the pair of planar membranes on opposite sides of the corrugated strut.
However, De La Rama teaches catheter structures with electrodes opposing each other (Fig 1, par. [0033] with opposing electrodes).
It would have been obvious to one of ordinary skill in the art to modify Guo with the opposing electrodes as in de la Rama, allowing for sensing in various configurations.
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobey in view of Guo.
Regarding claim 11, Tobey teaches an end effector of a catheter, the end effector comprising: a plurality of loop members arranged in a planar configuration such that a longitudinal axis of the catheter is parallel to a plane of the end effector (catheter 1022 with loop members 1040, 1044, 1046 parallel to the catheter axis), a first orthogonal axis is orthogonal to the plane of the end effector, and a second orthogonal axis is orthogonal to the longitudinal axis and orthogonal to the first orthogonal axis (as in Fig. 15); but is not explicit regarding a first support frame comprising a first corrugated strut extending through a first loop member of the plurality of loop members, corrugations of the first corrugated strut giving the corrugated strut a lateral stiffness in the second orthogonal axis, and an axial stiffness in the first orthogonal axis, the lateral stiffness being greater than the axial stiffness.
Guo teaches a first support frame comprising a first corrugated strut extending through a first loop member of the plurality of loop members (Fig. 4b, struts 14 for the end effector), with a lateral stiffness and an axial stiffness in a different axis, with the lateral stiffness greater than the axial stiffness (par. [0030] lowest stiffness as a sweeping plane and higher stiffness in the opposing plane as in par. [0046] along with stiffening element 16).
However, it would have been obvious to one of ordinary skill in the art to modify Tobey such that the loop members have a corrugated strut, as in Guo, to be able to provide for the curvatures of the loops.
Regarding claim 12, Tobey teaches a second loop member (1044), but is silent regarding a second support frame comprising a second corrugated strut extending through a second loop member of the plurality of loop members.
However, it would have been obvious to one of ordinary skill in the art to modify Tobey such that the loop members each have a corrugated strut, as in Guo, to be able to provide for the curvatures of the loops.
Regarding claim 13, Tobey is silent regarding the first corrugated strut being parallel to the second corrugated strut and extending parallel to the longitudinal axis.
However, one of ordinary skill in the art would appreciate that in the combination, as the loops of Tobey are parallel as in Fig. 15, the corrugated struts would also be parallel to each other and the longitudinal axis.
Regarding claim 14, Tobey teaches the plurality of loop members comprising outer spines parallel to the longitudinal axis (loops 1040, 1044, with spines outside of 1022 parallel to longitudinal axis as in Fig. 15), but is not explicit regarding the first corrugated strut and the second corrugated strut being respectively positioned within the outer spines.
However, Guo teaches the corrugated strut as above. it would have been obvious to one of ordinary skill in the art to modify Tobey such that the loop members each have a corrugated strut, as in Guo, to be able to provide for the curvatures of the loops.
Regarding claim 15, Tobey teaches the plurality of loop members comprising inner spines parallel to the longitudinal axis (inner spines as parts of spines that are closer to the longitudinal axis), but is not explicit regarding the first corrugated strut and the second corrugated strut being respectively positioned within the inner spines.
However, Guo teaches the corrugated strut as above. it would have been obvious to one of ordinary skill in the art to modify Tobey such that the loop members each have a corrugated strut, as in Guo, to be able to provide for the curvatures of the loops.
Regarding claim 16, Tobey teaches the plurality of loop members comprising the first loop member, a second loop member, and a third loop member (Fig. 15 with loops 1040, 1044, 1046), the first loop member and the third loop member each respectively comprising an outer spine and an inner spine (spine closer to the longitudinal axis and spine radially further from the axis), and the second loop member comprising central spines each between an outer spine and an inners spine of the first and second loop members (central spines at the distal ends of the loops as in Fig. 15).
Regarding claim 17, Tobey is not explicit regarding the first corrugated strut being positioned on a distal curved portion of the first loop member.
However, Guo teaches corrugated struts positioned in areas that are made to bend, as curved portions (par. [0036]).
However, it would have been obvious to one of ordinary skill in the art to modify the combination with the corrugated strut positioning, as in Guo, to be able to provide for the curvatures of the loops.
Regarding claim 18, Tobey teaches the first loop member comprising a first tubular housing at least partially surrounding the first support frame, the first tubular housing comprising a width greater than an amplitude of undulations of the first corrugated strut, the width being measured along the second orthogonal axis, and the amplitude being measured along the first orthogonal axis.
Guo teaches a first tubular housing comprising a width greater than an amplitude of undulations of the first corrugated strut (insulating structure 211 with a width greater than the amplitude of the undulations as in Fig. 5), the width being measured along the second orthogonal axis, and the amplitude being measured along the first orthogonal axis (Fig. 5, undulation amplitude less than the width of the elongated member).
However, it would have been obvious to one of ordinary skill in the art to modify the combination with the corrugated strut dimensions, as in Guo, to be able to provide for the curvatures of the loops.
Regarding claim 19, Tobey is silent, but Guo teaches the first loop member comprising a tubular
housing at least partially surrounding the first support frame (211), the end effector further comprising:one or more electrodes disposed on the tubular housing and linearly arranged in the plane of the end effector (13 on 211), the one or more electrodes comprising a ring electrode encircling the tubular housing (13 as a ring electrode as in at least Fig. 4a), and the ring electrode comprising an inner diameter greater than an amplitude of undulations of the first corrugated strut, the amplitude being measured along the first orthogonal axis (13 with an inner diameter greater than the undulations as in Fig. 5).
Regarding claim 20, Tobey is silent, but Guo teaches a wavelength of the undulations varying along a length of the corrugated strut (Fig. 11).
However, it would have been obvious to one of ordinary skill in the art to modify the combination with the corrugated strut dimensions, as in Guo, to be able to provide for the curvatures of the loops.
Response to Arguments
Applicant's arguments filed 3/20/26 have been fully considered but they are not persuasive. Applicant argues that Guo does not teach different bending stiffness in different directions, pointing to Guo teaching anisotropic bending stiffness. However, that definition refers to isotropic bending stiffness. Anisotropic refers to different in different directions.
Applicant’s arguments, see the arguments to claim 10, filed 3/20/26, with respect to the rejection(s) of claim(s) 10 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of De La Rama.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
/BO OUYANG/Examiner, Art Unit 3794
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