DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 30, 2026 has been entered.
This action is pursuant to the claims filed on March 30, 2026. Claims 38-39 and 42-59 are pending. Claims 1-37 and 40-41 is/are canceled. Claims 38-39 is/are withdrawn. A complete action on the merits of claims 42-59 is as follows.
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 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 § 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 42-54 are rejected under 35 U.S.C. 103 as being unpatentable over Winkler (WO 94/24931) in view of Avitall (U.S. Pat. No. 5,354,297), in view of Fung et al. (hereinafter ‘Fung’, U.S. Pat. No. 6,602,242), and further in view of Imbruce et al. (hereinafter ‘Imbruce’, U.S. Pat. No. 4,214,593).
In regards to independent claim 42, Winkler discloses a system for performing a diagnostic or therapeutic procedure within a subject (system comprising electrode-carrying catheter for mapping and therapy, pg. 1, ln. 19- pg. 2, ln. 13), comprising:
a device (electrode-carrying catheter 10 in Fig. 1A-1C) configured for insertion within a lumen or duct of the subject (pg. 2, ln. 10-13: the catheter is configured to pass through the human body), the device comprising:
an elongate body (catheter 10 formed of an elongate, flexible tube 12 in Fig. 1A) having a longitudinal axis, a proximal end (not shown), and a distal end (distal end of catheter 10 comprising electrode 30b);
one or more lumens extending within the elongate body (pg. 12, ln. 18-19: tube is hollow and defines a lumen 22 extending substantially along its entire length);
a first conductor carried within at least one of the one or more lumens (pg. 15, ln. 19-20: electrically conductive wires 33a & 33b), the first conductor having a proximal end and a distal end (conductive wire 33a comprises a proximal end (not shown) and a distal end shown in Fig. 1A);
an electrode (electrode 30a) carried on an exterior of the elongate body and electrically coupled to the distal end of the first conductor (electrode 30a is electrically connected to the conductive wire 33a as shown in Fig. 1A); and
However, the embodiment of Figs. 1A-1C does not disclose one or more conductor lumens extending within a wall of the elongate body.
In an alternate embodiment, Winkler discloses providing one or more conductor lumens extending within a wall of the elongate body (a plurality of lumens along sidewall 119 defining an outer surface 120 in Figs. 2A-2B), wherein the one or more conductor lumens each comprises a wire (133) for electrically coupling to an electrode (130) (pg. 19, ln. 9-18). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wall of the elongate body of Winkler’s first embodiment such that each of the conductors are disposed in its respective conductor lumen along the wall of the elongate body as taught by Winkler’s second embodiment, as doing so provides greater protection and support than providing the plurality of conductors within the single lumen of embodiment of Figs. 1A-1C (pg. 19, ln.9-18).
However, Winkler fails to explicitly disclose a connector having a first end configured to couple to an input of a control console configured for controlling operation of the device, and a second end electrically coupled to the proximal end of the first conductor.
Avitall teaches a catheter (catheter in Fig. 1) similar to that of Winkler. Avitall specifically discloses a handle portion (handle 10) comprising a connector (an electrical jack-type plug-in device 16) having a first end configured to couple to an input of a control console (col. 5, ln. 59-col. 6, ln. 2: the plug-in device 16 is configured to plug into an input/terminal of a recording system in a mapping mode or as output from a source of high frequency electrical power), and a second end electrically coupled to the proximal end of a plurality of conductors in electrical communication with a plurality of electrodes (col. 5, ln. 59-col. 6, ln. 2: the plurality of electrodes 44, 46, 48 are in electrically communication with the device 16 via electrical conductors 50, 52 and 43; the conductors are threaded through the catheter tubes 40 and 12 and the handle to connect with the internal portion of the jack 16). Although Winkler discloses connecting the device to a control console for mapping and therapy, given that Winkler does not explicitly disclose any specific structures associated with a connector configured to connect to a control console, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Winkler and incorporate the handle and the connector of Avitall for manipulating the catheter and to electrically connect the electrodes of Winkler to the control console as doing so involves routine skilled in the art and predictable result of operating in a recording mode and/or therapeutic mode would ensue.
Winkler/Avitall combination does not disclose wherein the elongate body comprises an internal lumen and a vent lumen defined by one or more vent walls.
Fung teaches a catheter (catheter 10 in Fig. 1) similar to that of Winkler, comprising a distal tip electrode (tip electrode 26 in Fig. 1) and a plurality of ring electrodes (ring electrodes 38 in Fig. 1). Specifically, Fung teaches that the catheter comprises a one or more conductor lumens extending within a wall of an elongate body (lumen 30 is shown in Fig. 3 comprising a plurality of lead wires 40 extending through the tubing 19 of the tip section 14 of the catheter 10, col. 6, ln. 23-25), a vent lumen defined by one or more vent walls (third lumen 34 of the tip section 14 is configured to inject fluid through the fluid passage 35, col. 8, ln. 7-38), and an internal lumen (lumen 32 is configured to provide puller wire 42, col. 7, ln. 61-65). Given that providing a vent lumen for injecting fluid to cool a distal tip electrode and providing lumen for incorporating pull wires are well-established in the medical catheter art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Winkler/Avitall combination and incorporate additional lumens (e.g. vent lumen and internal lumen) to provide a multi-lumen medical catheter having multiple functions to assist in navigating the body and cooling the distal end of the catheter tip during treatment procedure as doing so involves routine skilled in the art and a predictable result would ensue.
However, Winkler/Avitall/Fang combination does not disclose wherein the vent lumen is defined by one vent wall and a wall of the elongate body.
Imbruce teaches a catheter (device 2 in Fig. 1) comprising an elongate body (tube 10) comprising a plurality of lumens (lumens 12, 46 and 22). Specifically, each of the plurality of lumens (vent lumen 12, 22 and 46) is formed from a wall of the elongate body (wall of the tube 10) and a wall extending from the elongate body (the wall defining lumen 46). It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to provide the vent lumen defined by the wall of the elongate body and one vent wall as taught by Imbruce, since rearranging a centrally arranged vent tube to radially arranged vent tube formed from elongate body and a wall extending from the elongate body, i.e., vent lumen wall for the same purposes of irrigating or conductors involves routine skilled in the art.
In regards to claim 43, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the first conductor consists of a single strand of copper wire (pg. 15, ln. 16-22: electrically conductive wire 33 (e.g., 35 gauge copper wire)).
In regards to claim 44-46, Winkler/Avitall/Fang/Imbruce combination discloses the invention substantially as claimed in claim 43 and discussed above.
However, the first conductor of Winkler (33a in Fig. 1c) does not have a substantially 180 degrees bend thus forming a double-wire conductor.
Winkler teaches another conductor (33b in Fig. 1c) where the single conductor comprises a substantially 180 degrees bend, thus forming a double-wire conductor (the conductor 33b extends through the slot 40b and then passes rearwardly through the other of the aperture 42b). A first end of the double-wire conductor comprises a first end (the end of the wire 33b that extends rearwardly from the aperture 42b) and second end of the single strand (distal end of the wire 33b forming the U-shape), and wherein a second end of the double-wire conductor comprises the substantially 180 degrees bend of the single strand (the distal end of the wire 33b comprises the bend). The double-wire conductor is configured for a signal to travel in the same direction along a first elongate portion and along a second elongate portion alongside the first elongate portion (the signal travels from proximal end of the wire 33b to the distal end of the wire 33b during therapy and vice versa during mapping; therefore, depending upon the signal, it can be configured to travel along the same direction). Given that Winkler discloses a 180 degree bend, thus forming a double-wire conductor, it would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to modify the distal free end of the first conductor of Winkler so that the distal end of the first conductor forms a substantially 180 degrees bend (e.g. into the space directly adjacent to the slot 40b as extending the distal tip of the first conductor of Winkler), as doing so would not change any particular function of the first conductor and a structural rearrangement/modification allows for the free distal end to be more compactly positioned adjacent to the electrode.
In regards to claim 47, Winkler/Avitall/Fang/Imbruce combination further combination discloses wherein the first conductor comprises one or more of an elongated cured conductive epoxy, a conductive adhesive, and/or conductive ink (pg. 16, ln. 8-12the slot 40a and aperture 42a are occupied by the wire 33a via adhesive 34; pg. 14, ln. 15-26: note that the adhesive is electrically conductive adhesive securing the wire to the tube).
In regards to claim 48, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the first conductor comprises silver (pg. 14, ln. 1-2: the electrically conductive adhesive 34 is a silver conductive epoxy adhesive).
In regards to claim 49, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the first conductor consists of one or more of a conductive epoxy, a conductive adhesive, and/or a conductive ink, the first conductor substantially filing the one or more conductor lumen (lumen 30 is shown in Fig. 3 comprising a plurality of lead wires 40 extending through the tubing 19 of the tip section 14 of the catheter 10, col. 6, ln. 23-25).
In regards to claim 50, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the first conductor is embedded within the elongate body (see Fig. 2B).
In regards to claim 51, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the elongate body is overextruded with the first conductor (Fig. 1C illustrates the outer surface of the tube 12 is overextruded with respect to the wire 33a).
In regards to claim 52, Winkler/Avitall/Fang/Imbruce combination further discloses a first opening in an outer wall of the elongate body (opening 40a in Fig. 1A) directly adjacent the first conductor at a location along the elongate body (the wire 33a is adjacent to the opening 40a in Fig. 1A) that is substantially distal to the connector (the modified connector is proximal to the catheter and the wire 33a).
In regards to claim 53, Winkler/Avitall/Fang/Imbruce combination further discloses wherein a portion of conductive epoxy, a conductive adhesive, and/or a conductive ink, the first conductor in contact with and electrically coupled to the first conductor within the at least one of the one or more lumens adjacent the first opening (pg. 14, ln. 1-2: Fig. 1A illustrates a lumen 40a along the tube 12 which is filled with the electrically conductive adhesive 34).
In regards to claim 54, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the electrode is electrically coupled to the portion of conductive epoxy, conductive adhesive, or conductive ink (the adhesive 34 is electrically coupled to the wire 33a and electrode 30 as shown in Figs. 1A-1C).
In regards to claim 55, Winkler/Avitall/Fang/Imbruce combination further discloses wherein the electrode is a printed band around the exterior of the elongate body (Pg. 15, ln. 10-15: a flexible, thin layer of electrically conductive ink is printed over the adhesive to form the ring electrode 30).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Winkler, Avitall, Fang and Imbruce as applied to claim 42 above and further in view of Marian et al. (hereinafter ‘Marian’, U.S. Pat. No. 5,797,848).
In regards to claims 55-59, Winkler/Avitall/Fang/Imbruce combination discloses the invention substantially as claimed in claim 42 and discussed above.
However, Winkler/Avitall/Fang/Imbruce combination does not disclose wherein the proximal end of the first conductor is electrically coupled to the connector via an intermediate printed circuit, the printed circuit is a flex circuit and configured to wrap around at least a portion of the connector and the printed circuit comprises a conductive trace configured to electrically connect to the first conductor and a first conductive terminal of the connector.
Marian generally teaches a medical catheter (transducer assembly 10 in Fig. 1) comprising a shaft (elongate body 12), a connector (portion 16) and a disposable flexible printed circuit board (flexible, insulating substrate 34) wrapped around the connector (see Fig. 2) to connect with a receptacle/terminal (22) of a medical monitoring system (downstream of connector 38 (not shown)). Specifically, Marian teaches that the flexible printed circuit comprises a plurality of conductors (36 in Fig. 3) and a plurality of conductive trace (conductor portion that extends perpendicularly to the conductors 36) extending between a first trace location (one end of the perpendicular conductors in contact with the conductors 26) and a second trace location (another end of the perpendicular conductors in contact with the contact pads 18) so that the plurality of conductive traces are configured to contact one end of the connector (pads 18) which is configured to be inserted and plugged into the terminal (22). Given that Avitall discloses a jack-type plug connector (16 in Fig. 1, Avitall) comprising conductive contacts (pads 50, 52 and 54 in Fig. 1, Avitall), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the first conductor and the connector of Winkler/Avitall/Fang/Imbruce combination with a flexible printed circuit comprising the plurality of conductors, conductive traces, and a plurality of contact pads along a flex circuit and wrapping around the connector to form a plug-in conductive terminal of the connector as taught by Marian, as doing so allows the flexible printed circuit to be disposable and be produced at a low cost (col. 1, ln. 45-55).
Response to Arguments
Applicant’s arguments with respect to claim(s) 42-55 under 35 U.S.C. 103 as being unpatentable over Winkler, Avitall and Fang has been considered and are persuasive. Therefore, the rejection has been withdrawn. Upon further consideration, a new ground of rejection has been made under Imbruce as explained in above rejection.
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 4/28/2026
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