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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5) in the reply filed on July 15th, 2026 is acknowledged. Due to the amendment to claim 6, claims 6-10 are hereby included in examination such that the elected claims encompass claims 1-10.
Information Disclosure Statement
The information disclosure statement (IDS) submitted September 3rd, 2024 has been considered by the Examiner.
Claim Objections
Claims 1 & 7 objected to because of the following informalities:
Claim 1, lines 12-13: “the plurality of conductive traces is” should read --the plurality of conductive traces are--,
Claim 1, line 23: “the conductive traces” should read --the plurality of conductive traces--,
Claim 1, lines 23-24: “said conductive traces” should read --said plurality of conductive traces--,
Claim 7, lines 2-3: “at least some of the conductive traces” should read -- at least some of the plurality of conductive traces--.
Appropriate correction is required.
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 1-10 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 1, the claim recites “said conductive traces” in lines 17-18 and it is unclear if these are the same conductive traces as the plurality of conductive traces recited in line 10, those recited in line 16 or are different conductive traces. For examination purposes, these are the same conductive traces as those recited in line 16 and the limitation will be interpreted as “said plurality of conductive traces”. For other recitations, see Claim Objections section for correction.
Regarding claim 1, the claim recites “the conductive traces of the PCB proximal portion” in lines 18-19 and it is unclear if these are the same conductive traces as the plurality of conductive traces recited in line 10 or are different conductive traces. For examination purposes, these are the same conductive traces and the limitation will be interpreted as “the plurality of conductive traces of the PCB proximal portion”.
Claims 2-10 are also rejected by virtue of their dependency on claim 1.
Regarding claim 6, the claim recites “at least some of the conductive traces” in line 10 and it is unclear if these are the same conductive traces as the plurality of conductive traces recited in claim 1, from which claim 6 depends, or are different conductive traces. For examination purposes, these are the same conductive traces and the limitation will be interpreted as “at least some of the plurality of conductive traces”. For other recitations, see Claim Objections section for correction.
Claims 7-10 are also rejected by virtue of their dependency on claim 6.
Regarding claim 7, the claim recites “the conductive traces” in lines 3-4 and it is unclear if these are the same conductive traces as the plurality of conductive traces recited in claim 1, from which claim 7 depends, or are different conductive traces. For examination purposes, these are the same conductive traces and the limitation will be interpreted as “the plurality of conductive traces”.
Regarding claim 10, the claim recites “at least some of the conductive traces” in lines 1-2 and it is unclear if these are the same conductive traces as the plurality of conductive traces recited in claim 1, from which claim 10 depends, or are different conductive traces. For examination purposes, these are the same conductive traces and the limitation will be interpreted as “at least some of the plurality of conductive traces”.
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 1-2 & 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Berkowitz et al. (U.S. Pub. No. 20190175056), herein referred to as Berkowitz” in view of Wildes (U.S. Pub. No. 20170340861), herein referred to as “Wildes”.
Regarding claim 1, Berkowitz discloses a catheter (Abstract: Described herein is a catheter and method for catheter assembly; [0049]: Although features and elements are described above in particular combinations, one of ordinary skill in the art will appreciate that each feature or element can be used alone or in any combination with the other features and elements) comprising:
a shaft (catheter 200);
a distal end assembly (distal end 240) comprising an electrical connection array ([0032]: Distal end 240 of catheter 200 may include an electrode(s) 210 at distal tip 235; [0034]: Distal end 240 may include non-contact electrodes 220 arranged in an array);
an elongate flexible PCB (Printed Circuit Board) ([0039]: a printed flexible substrate 310) being housed within the shaft ([0043]: the configuration illustrated in FIG. 3, a printed flexible substrate 550 can be wrapped around an irrigation tube, for example, inside of catheter shaft 510; [0046]: inserting at least one encapsulated flexible substrate into a catheter shaft of a catheter), the elongate flexible PCB extending substantially along a full length of the shaft (see Fig. 3; [0039]; Printed flexible substrate 310 extends from distal end 320 to proximate end 330; wherein distal end 320 is the distal end of the catheter and proximate end 330 is the proximal end of the catheter) and comprising:
a PCB distal portion (distal portion of printed flexible substrate 310) comprising a plurality of distal electrical connection pads (distal end connectors 370) configured for establishing electrical connection with the electrical connection array of the distal end assembly ([0039]: distal end connectors 370 are connected to sensors; see also [0041] for each trace dedicated to an individual sensor);
a PCB proximal portion (proximal portion of printed flexible substrate 310) comprising a plurality of conductive traces (proximate end connectors 380) corresponding to the plurality of distal electrical connection pads of the PCB distal portion ([0039]: distal end connectors 370 are connected to sensors and proximate end connectors 380 are connected to cable 360 via cards or connectors in handle 340), wherein the plurality of conductive traces is configured to be electrically connectable to a connector (cable 360; [0039]: distal end connectors 370 are connected to sensors and proximate end connectors 380 are connected to cable 360 via cards or connectors in handle 340);
a PCB median portion (portion between connectors 370 and 380, Fig. 3) comprising:
a plurality of conductive traces ([0041]: In an implementation, each of layers 405, 410, 415, and 420 can include any number of traces) laid longitudinally along more than 75% of a length of the elongate flexible PCB (see Figs. 3-4), said conductive traces continuing the conductive traces of the PCB proximal portion and electrically connected to the plurality of distal electrical connection pads of the PCB distal portion ([0039]: Printed flexible substrate 310 includes distal end connectors 370 and proximate end connectors 380 … In particular, distal end connectors 370 are connected to sensors and proximate end connectors 380 are connected to cable 360 via cards or connectors in handle 340);
but Berkowitz fails to disclose a plurality of slits cutting through the PCB median portion between the conductive traces and extending along said conductive traces.
However, Wilde discloses a plurality of slits (slits 92) cutting through the PCB median portion between the conductive traces and extending along said conductive traces ([0032]: the conductors 14 are flex circuits 90 or flat ribbonized wires, coax, or optical fibers, they will tend to be flexible for out-of-plane bending but very stiff for in-plane bending. If omnidirectional bending (i.e., omnidirectional catheter steering) is needed, the flex circuits 90 or ribbonized conductor groups are slit (slit 92) into two or more strips). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the elongate flexible PCB of Berkowitz to include slits, as taught by Wilde, for the purpose of enabling the flexible circuit to be more flexible in-plane and will be more able to move and reorient within the catheter lumen to allow steering to large angles with minimum resistance (Wilde: [0032]).
Regarding claim 2, Berkowitz in view of Wilde discloses wherein the plurality of slits extends along more than 75% of the elongate flexible PCB (Wilde: [0032]: the flex circuits 90 or ribbonized conductor groups are slit (slit 92) into two or more strips of reduced in-plane width and lateral stiffness for the unbundled length (i.e., in deflection region 70) of the cable 12; see Fig. 3 where the deflection region is a majority of the catheter length).
Regarding claim 6, Berkowitz discloses a method of connecting the distal end assembly of the catheter of claim 1 to the connector at a proximal end of the catheter (Abstract: Described herein is a catheter and method for catheter assembly; [0049]: Although features and elements are described above in particular combinations, one of ordinary skill in the art will appreciate that each feature or element can be used alone or in any combination with the other features and elements), the method comprising:
providing the shaft (catheter 200; [0046]: In general, a method for catheter assembly includes printing conductive traces on at least one flexible substrate, encapsulating the at least one flexible substrate for environmental protection, inserting at least one encapsulated flexible substrate into a catheter shaft of a catheter);
providing the elongate flexible PCB extending substantially along the full length of the shaft ([0043]: the configuration illustrated in FIG. 3, a printed flexible substrate 550 can be wrapped around an irrigation tube, for example, inside of catheter shaft 510; [0046]: inserting at least one encapsulated flexible substrate into a catheter shaft of a catheter), having the plurality of conductive traces laid along the length of the elongate flexible PCB ([0039]; Printed flexible substrate 310 extends from distal end 320 to proximate end 330; wherein distal end 320 is the distal end of the catheter and proximate end 330 is the proximal end of the catheter);
inserting the elongate flexible PCB into the shaft such that the elongate flexible PCB extends at least the full length of the shaft ([0046]: inserting at least one encapsulated flexible substrate into a catheter shaft of a catheter; [0043]: the configuration illustrated in FIG. 3, a printed flexible substrate 550 can be wrapped around an irrigation tube, for example, inside of catheter shaft 510); and
connecting the plurality of distal electrical connection pads to the distal end assembly and a plurality of proximal electrical connection pads on a proximal end of the elongate flexible PCB to the connector ([0046]: attaching connectors to each end of the at least one encapsulated flexible substrate, attaching a set of connectors to sensors located at a distal end of the catheter, and attaching another set of connectors to electronics in a handle of the catheter; [0039]: distal end connectors 370 are connected to sensors and proximate end connectors 380 are connected to cable 360 via cards or connectors in handle 340), wherein the connector is configured to connect to a controller ([0039]: Handle 340 includes controls 350 and a cable 360 which connects to processing devices in a console, for example, console 120), wherein the controller is configured to communicate electrical signals between the controller and the distal end assembly ([0024]: Signal processor 140 can be included in a general-purpose computer, with a suitable front end and interface circuits for receiving signals from catheter 110 and controlling the other components of console 120).
But Berkowitz fails to disclose cutting the plurality of slits through the elongate flexible PCB between and parallel to at least some of the conductive traces.
However, Wilde discloses cutting the plurality of slits through the elongate flexible PCB between and parallel to at least some of the conductive traces ([0032]: the flex circuits 90 or ribbonized conductor groups are slit (slit 92) into two or more strips; [0033]: a scalpel was used to slit each of a set of ˜1.2 m long flex circuits 90 for a distance of ˜8.5 cm near one end). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Berkowitz to include the step of cutting the slits, as taught by Wilde, for the purpose of enabling the flexible circuit to be more flexible in-plane and will be more able to move and reorient within the catheter lumen to allow steering to large angles with minimum resistance (Wilde: [0032]).
Regarding claim 7, Berkowitz in view of Wilde disclose wherein cutting the plurality of slits through the elongate flexible PCB between and parallel to at least some of the conductive traces comprises cutting slits between all of the conductive traces (Wilde: [0019]: the portion of the cable within a steerable section of the steerable device is unbundled and divided into individual conductors; [0032]: the flex circuits 90 or ribbonized conductor groups are slit (slit 92) into two or more strips of reduced in-plane width and lateral stiffness for the unbundled length (i.e., in deflection region 70) of the cable 12).
Regarding claim 8, Berkowitz discloses rolling the elongate flexible PCB to an elongate tube shape ([0046]: In an implementation, the method includes wrapping an encapsulated flexible substrate around a component contained within the catheter shaft; [0043]: the configuration illustrated in FIG. 3, a printed flexible substrate 550 can be wrapped around an irrigation tube, for example, inside of catheter shaft 510).
Claims 3-4 & 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Berkowitz in view of Wilde as applied to claim 1, above, and further in view of Jacobsen et al. (U.S. Pub. No. 20140012130), herein referred to as “Jacobsen”.
Regarding claim 3, Berkowitz in view of Wilde fail to disclose wherein at least two of the plurality of conductive traces separated by a slit are twisted around each other.
However, Jacobsen discloses wherein at least two of the plurality of conductive traces separated by a slit are twisted around each other ([0113]: As shown in FIGS. 24M-24N, a pair of serpentine flexible circuits 430 can be braided together to form a flat twisted pair by combining two individual sinusoidal patterned base layers 434, each with three sinusoidally patterned traces explicitly braided into three flat pairs). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the elongate flexible PCB of Berkowitz in view of Wilde to include a twist, as taught by Jacobsen, for the purpose of reducing the influence of electromagnetic noise on the tracking system (Jacobsen: [0104]).
Regarding claim 4, Berkowitz in view of Wilde fail to disclose wherein the plurality of conductive traces are twisted along an elongate axis of the elongate flexible PCB.
However, Jacobsen discloses wherein the plurality of conductive traces are twisted along an elongate axis of the elongate flexible PCB ([0113]: As shown in FIGS. 24M-24N, a pair of serpentine flexible circuits 430 can be braided together to form a flat twisted pair by combining two individual sinusoidal patterned base layers 434, each with three sinusoidally patterned traces explicitly braided into three flat pairs). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the elongate flexible PCB of Berkowitz in view of Wilde to include a twist, as taught by Jacobsen, for the purpose of reducing the influence of electromagnetic noise on the tracking system (Jacobsen: [0104]).
Regarding claim 9, Berkowitz in view of Wilde fail to disclose twisting the PCB median portion.
However, Jacobsen discloses twisting the PCB median portion ([0113]: As shown in FIGS. 24M-24N, a pair of serpentine flexible circuits 430 can be braided together to form a flat twisted pair by combining two individual sinusoidal patterned base layers 434, each with three sinusoidally patterned traces explicitly braided into three flat pairs). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Berkowitz in view of Wilde to include twisting, as taught by Jacobsen, for the purpose of reducing the influence of electromagnetic noise on the tracking system (Jacobsen: [0104]).
Regarding claim 10, Berkowitz in view of Wilde fail to disclose twisting at least some of the conductive traces about each other, thereby producing a twisted plurality of conductors ([0113]: As shown in FIGS. 24M-24N, a pair of serpentine flexible circuits 430 can be braided together to form a flat twisted pair by combining two individual sinusoidal patterned base layers 434, each with three sinusoidally patterned traces explicitly braided into three flat pairs). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Berkowitz in view of Wilde to include twisting, as taught by Jacobsen, for the purpose of reducing the influence of electromagnetic noise on the tracking system (Jacobsen: [0104]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Berkowitz in view of Wilde as applied to claim 1, above, and further in view of Blanck et al. (U.S. Pub. No. 20220061808), herein referred to as “Blanck”.
Regarding claim 5, Berkowitz in view of Wilde fail to disclose wherein at least some of the plurality of slits extend all the way to an end of the elongate flexible PCB.
However, Blanck discloses wherein at least some of the plurality of slits extend all the way to an end of the elongate flexible PCB ([0030]: Within distal section 302, leaves 300 are bonded to each other; [0031] Conversely, within intermediate section 306, leaves 300 are loose and have disposed thereon a plurality of conductive connector pads 308. As used herein, the term “loose” means not bonded to each other; thus, within intermediate section 306, leaves 300 are not bonded to each other, and can therefore be referred to as “loose leaves” or a “loose leaf configuration.”; see Fig. 3). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the elongate flexible PCB of Berkowitz in view of Wilde to include slits that extend all the way to an end of the elongate PCB, as taught by Blanck, for the purpose of simplifying proof testing of flexible circuit during manufacture (Blanck: [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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