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 12/05/2024 was filed after the mailing date of the application on 12/05/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-2, 4, 8-9, 11-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suarez (US 2023/0165635), herein after “Suarez”.
Regarding claim 1, Suarez teaches
“A flexible circuit strip (Fig 7, 8A) for use in a catheter assembly (Fig. 1-4, basket catheter 10), comprising: (a) a first insulating layer (Fig. 8A, 24, p.[0111] "each of the flexible polymer circuit strips 24 has a polyimide layer") a second insulating layer (Fig. 8A, (68), p.[0118], "covering 68, such as a thermoplastic polymer resin shrink wrap (PET)") and a third insulating layer (Fig. 8A, (54), p.[0113] "suitable covering 54, e.g., thermoplastic polymer resin shrink wrap (PET)"), each having an elongated shape and bonded together such that the second insulating layer is between the first and third insulating layers (Fig. 8A, p.[0116-0121]);”
“(b) a conductive trace layer (p.[0116] "traces (not shown) on the back of the flexible polymer strips 24 to respective ones of the electrodes 26 disposed on the front of the flexible polymer circuit strips 24") positioned between the first and second insulating layers (p.[0120] "the circuit trace side of the flexible polymer circuit strip 24 facing the elongated resilient support element 48"), the conductive trace layer including longitudinal circuit traces for carrying electrical signals (p.[0116,0120]);”
“(c) electrodes (Fig. 8A, electrodes 26 and 55) positioned along a length of an outer surface of the first insulating layer and electrically connected to the circuit traces (p.[0116,0120]);”
“(d) a longitudinal hollow channel (area filled by elongated resilient support element 48 in Fig. 8A) formed between any two of the first, second and third layers, the longitudinal hollow channel being configured to receive an elongated support element (Fig. 8A, 48, p.[0116-0121]).”
Regarding claim 2, the limitations of claim 1 are taught as described above. Suarez teaches “further comprising a contact array positioned at a proximal end of the outer surface of the first insulating layer, wherein the electrodes are connected to the contact array using the circuit traces (Fig. 7, (connection array 60), p.[0116])”.
Regarding claim 4, the limitations of claim 1 are taught as described above. Suarez teaches “wherein each electrode is covered by an insulating cover (covering 54) including one or more apertures (apertures 55), the insulating cover being positioned over the electrode to expose selected portions of the electrodes (Fig. 8A, p.[0121])”.
Regarding claim 8, the limitations of claim 1 are taught as described above. Suarez teaches “wherein the first insulating layer (24) is thicker than the second (68) and third (54) insulating layers (as seen in Figure 8A)”.
Regarding claim 9, Suarez teaches “An expandable end effector for use in a catheter assembly (Figure 1), the expandable end effector comprising: (a) a spline retention hub (Fig. 1, 4, (16));”
“(b) an expandable basket assembly (Fig. 1-4, (22)) coupled to the spline retention hub, the expandable basket assembly comprising one or more flexible splines (Fig. 4 and 8A, (24 and 48)) coupled to the spline retention hub (Fig. 1, 4) and being configured to bow radially outward from a collapsed form to an expanded form (Fig 6A-B, p.[0114]), each flexible spline including: ”
“a flexible circuit strip comprising (Fig. 7, 8A): a first insulating layer (Fig. 8A, 24, p.[0111] "each of the flexible polymer circuit strips 24 has a polyimide layer") a second insulating layer (Fig. 8A, (68), p.[0118], "covering 68, such as a thermoplastic polymer resin shrink wrap (PET)") and a third insulating layer (Fig. 8A, (54), p.[0113] "suitable covering 54, e.g., thermoplastic polymer resin shrink wrap (PET)"), each having an elongated shape and bonded together such that the second insulating layer is between the first and third insulating layers (Fig. 8A, p.[0116-0121]);”
“a conductive trace layer (p.[0116] "traces (not shown) on the back of the flexible polymer strips 24 to respective ones of the electrodes 26 disposed on the front of the flexible polymer circuit strips 24") positioned between the first and second insulating layers (p.[0120] "the circuit trace side of the flexible polymer circuit strip 24 facing the elongated resilient support element 48"), the conductive trace layer including longitudinal circuit traces for carrying electrical signals (p.[0116,0120]); electrodes (Fig. 8A, electrodes 26 and 55) positioned along a length of an outer surface of the first insulating layer and electrically connected to the circuit traces (p.[0116,0120]);”
“electrodes (Fig. 8A, electrodes 26 and 55) positioned along a length of an outer surface of the first insulating layer and electrically connected to the circuit traces (p.[0116,0120]);”
“a longitudinal hollow channel (area filled by elongated resilient support element 48 in Fig. 8A) formed between any two of the first, second and third layers, the longitudinal hollow channel being configured to receive an elongated support element (Fig. 8A, 48, p.[0116-0121])”
“ii. an elongated support element disposed in the longitudinal hollow channel (Fig. 8A, elongated resilient support element 48, p.[0116-0121]).”
Regarding claim 11, the limitations of claim 9 are taught as described above. Suarez teaches “wherein the elongated support element is fixed within the longitudinal hollow channel (p.[0118, 0220])”.
Regarding claim 12, the limitations of claim 9 are taught as described above. Suarez teaches “wherein the expandable basket assembly comprises a first flexible spline having a proximal end coupled to the spline retention hub and a distal end of a first flexible spline coupled to a distal end of a second flexible spline (Fig. 4-5, Fig. 7, (34), p.[0108])”.
Regarding claim 13, the limitations of claim 9 are taught as described above. Suarez teaches “further comprising a pusher disposed coaxially within the spline retention hub and configured to be translated relative thereto along a hub longitudinal axis (18, Fig. 4, Fig. 6A-B)”,
“each of the one or more flexible spline having a proximal end coupled to the spline retention hub and a distal end coupled to a distal end of the pusher, the one or more flexible spline being configured to bow radially outward when the pusher is retracted relative to the spline retention hub, thereby expanding the expandable basket assembly from a collapsed form to an expanded form (p.[0114])”.
Regarding claim 14, the limitations of claim 9 are taught as described above. Suarez teaches “wherein the one or more flexible spline is configured to bow radially outward upon release of radial constraint (Fig. 4, Fig. 6A-B, p.[0114]).”
Regarding claim 15, the limitations of claim 14 are taught as described above. Suarez teaches “wherein the one or more flexible spline comprises a proximal end and a distal end both coupled to the spline retention hub (Fig. 1, coupler 16)”.
Regarding claim 16, the limitations of claim 9 are taught as described above. Suarez teaches “comprising a plurality of flexible splines forming a basket in the expanded form (Fig. 1-4, expandable assembly 22)”.
Regarding claim 18, the limitations of claim 9 are taught as described above. Suarez teaches “wherein the elongated support element comprises shape-set nitinol (p.[0105])”.
Regarding claim 19, Suarez teaches “A catheter assembly (Fig. 1, (10)) comprising: a tubular shaft (Fig. 1, (12)) extending along a longitudinal axis extending from a proximal portion of the tubular shaft to a distal portion of the tubular shaft (Fig. 1, (14)), an expandable end effector (Fig. 1-4, (22)) comprising:
(a) a spline retention hub (Fig. 1, 4, (16));
(b) an expandable basket assembly (Fig. 1-4, (22)) coupled to the spline retention hub, the expandable basket assembly comprising one or more flexible splines (Fig. 4 and 8A, (24 and 48)) coupled to the spline retention hub (Fig. 1, 4) and being configured to bow radially outward from a collapsed form to an expanded form (Fig 6A-B, p.[0114]), each flexible spline including:
i. a flexible circuit strip comprising (Fig. 7, 8A): a first insulating layer (Fig. 8A, 24, p.[0111] "each of the flexible polymer circuit strips 24 has a polyimide layer") a second insulating layer (Fig. 8A, (68), p.[0118], "covering 68, such as a thermoplastic polymer resin shrink wrap (PET)") and a third insulating layer (Fig. 8A, (54), p.[0113] "suitable covering 54, e.g., thermoplastic polymer resin shrink wrap (PET)"), each having an elongated shape and bonded together such that the second insulating layer is between the first and third insulating layers (Fig. 8A, p.[0116-0121]);”
“a conductive trace layer (p.[0116] "traces (not shown) on the back of the flexible polymer strips 24 to respective ones of the electrodes 26 disposed on the front of the flexible polymer circuit strips 24") positioned between the first and second insulating layers (p.[0120] "the circuit trace side of the flexible polymer circuit strip 24 facing the elongated resilient support element 48"), the conductive trace layer including longitudinal circuit traces for carrying electrical signals (p.[0116,0120]); electrodes (Fig. 8A, electrodes 26 and 55) positioned along a length of an outer surface of the first insulating layer and electrically connected to the circuit traces (p.[0116,0120]);”
“electrodes (Fig. 8A, electrodes 26 and 55) positioned along a length of an outer surface of the first insulating layer and electrically connected to the circuit traces (p.[0116,0120]);”
“a longitudinal hollow channel (area filled by elongated resilient support element 48 in Fig. 8A) formed between any two of the first, second and third layers, the longitudinal hollow channel being configured to receive an elongated support element (Fig. 8A, 48, p.[0116-0121])”
“ii. an elongated support element disposed in the longitudinal hollow channel (Fig. 8A, elongated resilient support element 48, p.[0116-0121]).”
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (CN 101426342 A), herein after “Chen”.
Regarding claim 20, Chen teaches
“A method of manufacturing a flexible circuit strip (Fig. 11, (20)), comprising:
(a) providing an elongated multilayer laminate (Fig. 11, (20)), wherein the multilayer laminate comprises an insulating layer (Fig. 11, (12)) comprising a flexible polymer (page 6, second paragraph; claim 8), a conductive channel layer (Fig. 11, (11a))clad onto the insulating layer and comprising a conductive material (p.[0032]), an adhesive layer (p.[0034,0042, 0049]) and another insulating layer (Fig. 11, (16)) comprising said flexible polymer (claim 8);
(b) drilling (p.[0006,0047]) the multilayer laminate to form an opening (Fig. 11 (161)) through said another polymer layer and the adhesive layer to expose the conductive channel layer;
(c) etching the conductive channel layer to form a longitudinal hollow channel in the elongated multilayer laminate (Fig. 10, (11a), p.[0006,0011,0012,0035-0038, 0042-0045,0050])”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Suarez in view of Elolampi (US 9,159,635 B2), herein after “Elolampi”.
Regarding claim 3, the limitations of claim 2 are taught as described above. Suarez does not explicitly teach "wherein the connection between the circuit traces and the electrodes is established through vias extending through the first insulating layer" however Elolampi does in an analogous electrode device. Elolampi teaches "wherein the connection between the circuit traces and the electrodes is established through vias extending through the first insulating layer" in col. 10, lines 64-67 and col. 11, lines 1-16. 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 vias of Elolampi in Suarez. The use of vias is known in the art and provides a predictable result of providing a trench for sheltering electronic connections.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Suarez in view of Harlev (US 8,103,327 B2), herein after “Harlev”.
Regarding claim 5, the limitations of claim 1 are taught as described above. Suarez does not explicitly teach "wherein the electrodes and circuit traces comprise gold", but Harlev does in an analogous catheter device. Harlev teaches "wherein the electrodes (col. 9, lines 24-31) and circuit traces comprise gold (col. 10, lines 65-67, col. 11, lines 1-10)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use electrodes and circuit traces comprising gold. It is known in the art to use gold for electrodes and circuits that are used in the body due their biocompatibility and reduction of impedance (col. 9, lines 24-31) and using gold produces predictable results of safe use in the human body and reduced impedance.
Regarding claim 7, the limitations of claim 1 are taught as described above. Suarez does not explicitly teach "wherein the conductive trace layer comprise gold", but Harlev does in an analogous catheter device. Harlev teaches "wherein the conductive trace layer comprises gold (col. 10, lines 65-67, col. 11, lines 1-10)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use conductive trace layer comprising gold. It is known in the art to use gold conductive trace layers that are used in the body due their biocompatibility and produces predictable results of safe use in the human body.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Suarez in view of Avall (US 2024/0252258), herein after “Avall”.
Regarding claim 6, the limitations of claim 1 are taught as described above. Suarez does not explicitly teach "wherein the first, second, and third insulating layers comprises polyimide" but Avall does in an analogous catheter device. Avall teaches "wherein the first (403a), second (403b), and third (403c) insulating layers comprises polyimide (p.[0104] "each of flexible layers 403 includes an electrical insulator material (e.g., polyimide)")". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyimide as an insulating layer, as taught in Avall, in Suarez. The use of polyimide is known in the art for use in flexible circuit strips and produces predictable results of providing insulation.
Claims 10 and 17 are rejected under 35 U.S.C. 103 as unpatentable over Suarez in view of Kordis (US 8,346,339 B2) herein after “Kordis”.
Regarding claim 10, the limitations of claim 9 are taught as described above. Suarez does not teach "wherein the elongated support element is arranged to have play within the longitudinal hollow channel, allowing for longitudinal adjustment therein" but Kordis does in an analogous catheter device. Kordis teaches "wherein the elongated support element is arranged to have play within the longitudinal hollow channel, allowing for longitudinal adjustment therein (Fig. 31C, elongated support element 14 with slot 168, col. 17 lines 26-67, col. 18 lines 1-4)". 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 elongated supports of Kordis in Suarez to arrive at the claimed invention. The orientation of the elongated support elements allows for variable positioning of the basket splines and aids in collapsing of the basket and produces predictable results of varying the basket configuration.
Regarding claim 17, the limitations of claim 9 are taught as described above. Suarez does not teach "wherein the elongated support element is fitted to the longitudinal hollow channel and secured loosely using an adhesive so as to have longitudinal play" but Kordis does in an analogous catheter device. Kordis teaches "wherein the elongated support element is fitted to the longitudinal hollow channel and secured loosely using an adhesive so as to have longitudinal play (Fig. 31C, elongated support element 14 with slot 168, col. 17, lines 61-62, " The basket splines 14 may be attached to the anchor 158 by adhering with glue, welding, crimping or the like")". 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 Kordis in Suarez. The orientation of the elongated support elements allows for variable positioning of the basket splines and aids in collapsing of the basket and produces predictable results of varying the basket configuration.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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