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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/13/2025 was filed after the mailing date of the Non-Final Office Action on 10/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claim 1 is amended. Claim 5 is cancelled. Claims 1-4, 6-20 are under examination herein.
Response to Arguments
Applicant’s arguments, see Remarks pages 7-8, filed 01/09/2026, with respect to the rejection of claims 1-9, 11, and 15-20 as being unpatentable over Harlev (WIPO WO 2021/0126980) have been fully considered and are persuasive. The Examiner notes that Harlev does not explicitly show an example of how the structural unit is configured to assume a cylindrical shape in an expanded configuration, and therefore, the rejection has been withdrawn. However, the Examiner now cites Bakos (U.S. Patent No. 10,341,649 B2) in view of the amendments filed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-9, 11, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (WIPO Patent Publication WO 2021/0126980) and Bakos (US Patent No. 10,341,649 B2).
Regarding claim 1, Harlev teaches “A structural unit for an end effector (Fig. 2, 124; Figs. 7A-B, 750) comprising”, “a proximal member extending along a longitudinal axis (Fig. 7A, 757), the proximal member defining a plurality of divergent curvilinear members (Fig. 7A, 751 at the bottom right of the mesh originating from 757, as described in p.[0052])”, and “a distal member connected to the plurality of convergent curvilinear members (Fig. 7A, 755)”.
However, Harlev does not directly teach the use of meander members, and instead teaches branches in Figure 7A, where the branches emanating left and right of 751 result in forming cells 753 as further described in p.[0054]. However, even though Harlev does not describe the meandering shape for the members (where Fig. 7A shows zig-zag shapes for the members), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a meandering shape instead of zig-zag. The problem to be solved by the present invention is providing an alternative mesh shape for the structural end effector unit, and it is generally known in the art that the feature of ovoid mesh cells formed by meander members in claim 1 would be equivalent to the diamond-shaped cells of Harlev . Further, Harlev states in p.[0060] that the cells can be flexible in axial and lateral directions, suggesting that the branches that form the cells are similarly flexible in axial and lateral directions, and could be manipulated to form a meandering shape if desired. The use of meandering versus zig-zag members would have been determined by one of ordinary skill in the art before the effective filing date of the claimed invention through routine optimization, and it has been held by the courts that changing the mere shape of a component does not provide any patentable distinction or non-obvious results. See MPEP 2144IIA, "Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.")."
Further, Harlev teaches “the structural unit being configured to transition between a collapsed configuration and an expanded configuration” in Figures 3A-4 which shows that the structural unit can be in a collapsed or expanded configuration and is further described in p.[0027], which teaches the limitation as described.
Note that Harlev does not explicitly teach that the structural unit forms a generally cylindrical structure, but does teach that the structural unit can assume a generally cylindrical shape, as stated in p.[0039]. As stated previously in the Response to Argument section, Harlev does not show a specific example of a cylindrical shape, so for the sake of thorough and compact prosecution, the Examiner cites an additional piece of pertinent prior art, Bakos (U.S. Patent No. 10,341,649 B2). Bakos, an analogous flexible expandable electrode assembly, teaches the use of basket members 52 that are braided into a cylindrical or tube-like arrangement in Figure 11. Note that for the record, the picture of Figure 11 constitutes as an enabling disclosure according to MPEP 2121.04. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cylindrical member of Bakos in Harlev. Harlev already considers the use of a cylindrical structure, and further, Bakos recognizes that the use of a cylindrical member allows for the structure to assume a contracted state while traversing through the lumen and an expanded state when delivered to the tissue site and produces predictable results (col. 26, lines 55-67, col. 27 lines 1-22).
Regarding claim 2, the limitations of claim 1 are taught as described above. Harlev teaches “wherein each meander member of the plurality of meander members is connected to an adjacent meander member of the plurality of meander members”, in Figure 7A shows meeting points of the zig-zag lines on the central axis, as defined at 757 and 755, and therefore teaches the limitation as described.
Regarding claim 3, the limitations of claim 1 are taught as described above. Harlev teaches “further comprising a plurality of electrodes attached to the structural unit” in Figure 8A, which shows sensors 826 attached to components of the structural unit 750 as described p.[0091-0092] and teaches the limitation as described.
Regarding claim 4, the limitations of claim 3 are taught as described above. Harlev teaches “wherein the plurality of electrodes comprises one or more electrodes disposed between adjacent meander members of the plurality of meander members” in Figure 8B which shows sensors 826 disposed on adjacent curvilinear members 751 and teaches the limitation as described.
Regarding claim 5, the limitations of claim 1 are taught as described above. Harlev teaches “the structural unit being configured to transition between a collapsed configuration and an expanded configuration” in Figures 3A-4 which shows that the structural unit can be in a collapsed or expanded configuration and is further described in p.[0027], which teaches the limitation as described.
Regarding claim 6, the limitations of claim 1 are taught as described above. Claim 6 comprises all the limitations of claim 1, except that claim 6 describes that the structural members form a generally cylindrical structure, whereas claim 1 does not. However, Harlev does teach an end effector with a generally cylindrical structure outside of the embodiments described in claim 1, in Figure 6A-B and further described in p.[0050]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assume a cylindrical state, as shown in Figure 6A. It is known in the art to use a lumen-like, or cylindrical form factor when constructing an end effector for a probe that has to navigate lumens and cylindrical organs/passageways and such a form factor produces predictable results. Further, p.[0149-0152] recognizes that modifications can be made without deviating from the scope of Harlev, and embodiments may be combined or integrated as readily understood by one of ordinary skill in the art. Note that Harlev does not explicitly teach that the structural unit forms a generally cylindrical structure, but does teach that the structural unit can assume a generally cylindrical shape, as stated in p.[0039]. As stated previously in the Response to Argument section, Harlev does not show a specific example of a cylindrical shape, so for the sake of thorough and compact prosecution, the Examiner cites an additional piece of pertinent prior art, Bakos (U.S. Patent No. 10,341,649 B2). Bakos, an analogous flexible expandable electrode assembly, teaches the use of basket members 52 that are braided into a cylindrical or tube-like arrangement in Figure 11. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cylindrical member of Bakos in Harlev. Harlev already considers the use of a cylindrical structure, and further, Bakos recognizes that the use of a cylindrical member allows for the structure to assume a contracted and expanded state while traversing through the lumen and produces predictable results.
Regarding claim 7, the limitations of claim 6 are taught as described above. Harlev teaches “wherein the end effector is configured to transition between a collapsed configuration and an expanded configuration” in Figures 3A-4 show that the structural unit can be in a collapsed or expanded configuration and is further described in p.[0027], therefore the limitation is taught as described.
Regarding claim 8, the limitations of claim 6 are taught as described above. Harlev teaches “wherein each meander member of the plurality of meander members is connected to an adjacent meander member of the plurality of meander members” in Figure 7A shows meeting points of the zig-zag lines on the central axis, as defined at 757 and 755, and therefore teaches the limitation as described.
Regarding claim 9, the limitations of claim 6 are taught as described above. Harlev teaches “further comprising a plurality of electrodes attached to the generally cylindrical structure” in Figure 8A, which shows sensors 826 attached to components of the structural unit 750 as described p.[0091-0092] and teaches the limitation as described.
Regarding claims 11, the method of construction described in these claims is taught by the rejection of claim 9, as described above. MPEP 2113 states that “”[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Because claim 9 teaches that the structure of the electrodes on the generally cylindrical structure, claim 9 teaches the rejection of claim 11 even though claim 9 does not describe that the electrodes are formed by vacuum deposition.
Regarding claim 15, the limitations of claim 6 are taught as described above. Harlev teaches the limitation “further comprising an electromagnetic coil attached to the generally cylindrical structure, the electromagnetic coil configured to detect a magnetic field for position sensing” in p.[0099-0101], specifically "… the tip section can include one or more location coil sensors (e.g., magnetic coil sensors)". Note that the tip section is attached to the end effector (the generally cylindrical structure) and therefore teaches the claimed limitation as described.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev (WIPO Patent Publication WO 2021/0126980) and Bakos (US Patent No. 10,314,649 B2) in view of Tegg (US Patent Publication 2020/0060569).
Regarding claim 10, the limitations of claim 9 are taught as described above. Harlev/Bakos does not teach that the plurality of electrodes comprises a fist electrode disposed between the proximal member and the plurality of divergent curvilinear members, but Tegg does in an analogous expandable end effector device. Tegg shows proximal member 114, with first electrode 122-2 disposed between a plurality of divergent curvilinear embers 106 in Figure 3A and p.[0040], and therefore teaches the claimed limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Tegg in Harlev/Bakos. It is known in the art to use electrodes in varying positions to determine alternative characteristics of the end effector, such as energy use, temperature of the tissue, temperature of the end effector, and the like, and the mere presence of additional electrodes on an end effector does not produce any novel or non-obvious results.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev (WIPO Patent Publication WO 2021/0126980) and Bakos (US Patent No. 10,314,649 B2) in view of Squires (US Patent Publication 2020/0205689).
Regarding claim 12, the limitations of claim 9 are taught as described above. Harlev/Bakos does not teach the use of a reference electrode attached to the end effector; however, Squires does in an analogous expandable end effector. Squires teaches in p.[0037] of reference electrodes being attached to the spines 52 (synonymous to the meandering members), and therefore teaches the claimed invention. It would have been obvious to one of ordinary skill in the art to use a reference electrode on the cylindrical structure, as taught in Squires, in Harlev/Bakos. As stated in Squires, the use of the reference electrode on the cylindrical structure allows for the device to determine the new and far fields of signals in the body and produces predictable results (p.[0037]).
Regarding claim 13, the limitations of claim 12 are taught as described above. Neither Squires nor Harlev/Bakos explicitly teach that the reference electrode is positioned proximate an electrode of the plurality of electrodes, however, Squires does anticipate the need for alternative configurations of the reference electrode in comparison to the plurality of electrodes as described in p.[0084]. Squires states that "Alternatively, any other suitable configurations can also be used, for example, using any suitable number of electrodes and/or reference electrodes having any suitable distances therebetween", suggesting that one of ordinary skill in the art could move the reference electrode into a proximal location some distance away from the plurality of electrodes, as needed and desired for a medical procedure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a reference electrode proximate the plurality of electrodes, as suggested in Squires, in Harlev/Bakos. As stated in Squires, the reference electrode can be moved to any suitable position and distance away from the plurality of electrodes, and such modification produces a predictable result.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev (WIPO Patent Publication WO 2021/0126980) and Bakos (US Patent No. 10,314,649) in view of Pomeranz (US Patent 6,014,579).
Regarding claim 14, the limitations of claim 9 are taught as described above. Harlev/Bakos does not teach the use of electrical traces on the structural members to connect to electrodes, however, Pomeranz does in an analogous expandable catheter device. Pomeranz teaches in col. 3, lines 60 - col. 4, line 7 that the electrodes 46 attached to the arms 38 (synonymous to structural member) have a trace 49 to electrically connect the electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use traces formed on the structural members to connect electrodes, as taught in Pomeranz, in Harlev/Bakos. It is known in the art to use traces to electrically connect electrical components and produces predictable results.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Basu (US Patent Publication 2021/077184).
Regarding claim 16, Basu teaches “A method of constructing a medical probe (Figs. 2, 9, 10), the method comprising”, “forming a plurality of spines from a planar sheet of material (Fig. 9, p.[0058-0059])”, “forming a plurality of electrodes on the planar sheet of material by vacuum deposition (Fig. 9, p.[0061], [0099])”, and “forming a plurality of electrical traces on the planar sheet of material, each electrical trace of the plurality of electrical traces being connected to a respective electrode of the plurality of electrodes (p.[0061])”. Basu does not teach "connecting opposite ends of the planar sheet of material to each other to form a cylindrical structure" in the embodiment currently described in the rejection, however, Basu does describe the use of a cylindrical structure in an alternative embodiment, as described in Fig. 6, and p.[0051]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the embodiment of Figure 6 and p.[0051] in Figure 9 of Basu. As stated in p,[0051], the use of the cylindrical structure may "make the end effector particularly suitable for use in the pulmonary vein" and further, stated in p.[0117] which states "It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein."
Regarding claim 17, the limitations of claim 16 are taught as described above. Basu teaches that “the cylindrical structure being configured to transition between a collapsed configuration and an expanded configuration” in p.[0068], p.[0098], that the device can assume both an unexpanded and expanded configuration, and therefore teaches the limitation as described.
Regarding claim 18, the limitations of claim 16 are taught as described above. Basu teaches the use of curvilinear spines in Figure 9, and Harlev also teaches the use of curvilinear spines in Figures 3A-4 and curvilinear members 755 in Figure 7A. It is known in the art to use curvilinear members as spines within an expandable basket and produces predictable results.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Basu (US Patent Publication 2021/077184) in view of Harlev (WIPO Patent Publication WO 2021/0126980).
Regarding claim 19, the limitations of claim 16 are taught as described above. Basu does not teach “wherein each electrode is positioned at an intersection between two adjacent spines of the plurality of spines”, but Harlev does in an analogous expandable catheter device. Harlev teaches this limitation in Figure 8A, which shows sensors 826 attached to components of the structural unit 750 as described p.[0091-0092] and teaches the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the orientation described in Harlev in Basu. The position of the electrodes is a mere matter of design choice and produces predictable results.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Basu (US Patent Publication 2021/077184) in view of Harlev (WIPO Patent Publication WO 2021/0126980) and Squires (US Patent Publication US 2020/0205689).
Regarding claim 20, the limitations of claim 19 are taught as described above. Neither Basu nor Harlev explicitly teach that the reference electrode is positioned proximate an electrode of the plurality of electrodes, however, Squires does anticipate the need for alternative configurations of the reference electrode in comparison to the plurality of electrodes as described in p.[0084]. Squires states that "Alternatively, any other suitable configurations can also be used, for example, using any suitable number of electrodes and/or reference electrodes having any suitable distances therebetween", suggesting that one of ordinary skill in the art could move the reference electrode into a proximal location some distance away from the plurality of electrodes, as needed and desired for a medical procedure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a reference electrode proximate the plurality of electrodes, as suggested in Squires, in Harlev/Basu. As stated in Squires, the reference electrode can be moved to any suitable position and distance away from the plurality of electrodes, and such modification produces a predictable result.
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 Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794