DETAILED ACTION
This action is pursuant to response filed on 4/3/2026. Claims 1-20 are pending, claims 15-20 have been withdrawn in the Applicant’s response filed 4/3/2026. A first action on the merits of claims 1-14 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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/3/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the liner layer of the inner surface in claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3 and 4-7 are 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.
Claim 3 is rejected because “the proximal braided member” and “the distal braided member” lack antecedent basis.
Claim 4 is rejected because it is unclear if “a reinforcement member” is the same reinforcement member of claim 1 or a new reinforcement member. For the purposes of compact prosecution, it will be interpreted as the same reinforcement member.
Similarly, claims 5 and 6 are rejected because it is unclear if “the reinforcement member” is the reinforcement member of claim 1 or claim 4.
Claims 5-7 are rejected due to their dependance on claim 4.
Claim 7 is additionally rejected because “the longitudinal side” lacks antecedent basis. Each piece of the device has a longitudinal side and it is unclear if this is intended to be the longitudinal side of the shaft, inner member, support member, reinforcement member, or elongated tube.
Claim 7 is also rejected because “the axis” lacks antecedent basis.
Claim 7 is also rejected because “the opening of the reinforcement member” lacks antecedent basis.
Claim 9 is rejected because “the shaft” lacks antecedent basis.
Claim 13 is rejected because “the shaft” lacks antecedent basis.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7, 9-10, 12, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tang et al. (hereinafter ‘Tang’, US 20180153434 A1).
Regarding independent claim 1, Tang discloses a catheter (device of Fig. 1), comprising:
an elongated shaft (Figs. 1, 4: elongate shaft 12) defining a lumen (Fig. 4: 22) along a longitudinal axis and having a distal portion (Fig. 1: portions 14 and 15 that are disposed away from the handle); the shaft comprising:
a longitudinally extending inner member (Fig. 4: inner liner 25) defining the lumen (Fig. 4: liner 25 defines the lumen 22);
a support member (Fig. 4: braided layer 26) disposed on the longitudinally extending inner member (Fig. 4: 26 is disposed on the liner 25), the support member including a proximal portion ([0044]: the braided member surrounds the liner 25 along its length; the proximal portion is the portion closest to the handle) and a distal portion (the distal portion is the portion furthest from the handle where tubing 40 is disposed on top of the braid) separated by a breakout section (breakout section J in Fig. 1; [0047]: junction J defines a location of a transition portion of each tubing 40 that transitions between below and above the braided layer 26), the distal portion having an outer surface (outer surface of braided layer 26 in Fig. 4); and
a reinforcement member (reinforcement member 48 in Figs 3 and 4) disposed on the breakout section (disposed on the breakout section as seen in Fig. 4; as seen in Figs. 3A and B, the reinforcement member 48 is disposed over the tubes 40 even after they pass the breakout section and are disposed over the braided layer 26) and having a reinforcement proximal end (portion closest to handle) and a reinforcement distal end (portion furthest from the handle), the reinforcement proximal end coupled to the proximal portion and the reinforcement distal end coupled to the distal portion ([0052]: the shaft 12 along its length includes an outer layer or coating 48 that extends over braided layer 26 and seals all of the underlying components – since it covers the length of the shaft 12 and the braided layer 26, it is coupled to the proximal end and the distal end);
an electrode disposed on the distal portion of the elongated shaft (Fig. 1: distal most electrode 19 disposed in section 14);
an elongated tube extending longitudinally along the elongated shaft (Figs. 2-6: elongate tube 40 extending along the shaft 12); and
a lead conductor disposed within the tube (Figs. 2-6: lead 42 disposed within tube 40) and electrically coupled to the electrode ([0047]: also extending longitudinally along the shaft 12 are one or more elongated lead wire tubings 40, each with a lumen 41 for one or more lead wires 42 and each lead wire connected to a respective ring electrode 19 for transmitting electrical signals sensed by the ring electrode 19);
wherein the tube extends longitudinally along the proximal portion radially underneath the proximal portion, extends longitudinally on the outer surface along the distal portion, and extends from underneath the proximal portion to the outer surface ([0047]: in the proximal portion of the shaft 12, each tubing 40 lies under or below and surrounded by the braided layer 26. In the distal deflection portion 14 of the shaft 12, each tubing 40 lies above or outside the braided layer 26. A junction J defines a location of a transition portion of each tubing 40 that transitions between below and above the braided layer 26) at the reinforcement member (this transition occurs at the reinforcement member 48 because it is on a portion which is covered by member 48 as described above – the claim does not limit that the tube must extend to outside of the reinforcement member or that the reinforcement member is only disposed at the breakout section).
Regarding claim 2, Tang discloses the catheter of claim 1, wherein the support member is formed of a braided material ([0044]: braided member 26 is formed of braided strands 27).
Regarding claim 3, Tang discloses the catheter of claim 1, wherein the proximal braided member and the distal braided member include conductive fibers ([0044]: the strands or fibers 27 can be made of stainless steel – stainless steel is known in the art to be conductive and the claim does not claim the actual material or the required conductivity).
Regarding claim 4, Tang discloses the catheter of claim 1, wherein the elongated shaft further comprises a reinforcement member (reinforcement member 48 in Fig. 4) having a tubular longitudinal side (48 is tubular as seen in Fig. 4), a reinforcement proximal end (portion closest to the handle), and a reinforcement distal end (portion furthest from the handle), the reinforcement proximal end operably coupled to the proximal portion and the reinforcement distal end operably coupled to the distal portion ([0052]: the shaft 12 along its length includes an outer layer or coating 48 that extends over braided layer 26 and seals all of the underlying components – since it covers the length of the shaft 12 and the braided layer 26, it is coupled to the proximal end and the distal end).
Regarding claim 7, Tang discloses the catheter of claim 4, wherein the longitudinal side extends along the axis (longitudinal side of 48 extends along the axis as seen in Fig. 4) and an opening is formed on the longitudinal side (opening through which tube 40 is residing in Fig. 3A and 3B – an opening formed on the longitudinal side does not have to penetrate in the radial direction as claimed and a channel running along the side of the tube is an opening on the longitudinal side), and wherein the tube extends from underneath the proximal portion to the outer surface through the opening of the reinforcement member (as seen in Figs. 2, 3A, 3B and 4, the tubing 40 is residing in the opening in the reinforcement layer 48 as it transitions from underneath the braid to the outer surface of the braid – the tubing resides in the opening as it transitions, thus it transitions through the tube).
Regarding claim 9, Tang discloses the catheter of claim 1, wherein the shaft includes an outer layer disposed on the support member and the reinforcement member (the outer layer is the proximal most electrode 19 in Fig. 1; as seen in Fig. 3A, the electrode is a layer that covers the braid and reinforcement member; claim 1 only claims a single electrode which is mapped to the distal most electrode in Fig. 1, therefore it is proper to map a different electrode to this outer layer since there is no specific structure or function claimed for this outer layer).
Regarding claim 10, Tang discloses the catheter of claim 1, wherein the elongate tube includes a plurality of elongate tubes radially spaced-apart on the outer side of the distal portion ([0047]: there can be one or more tubings 40, and are spaced at radial locations different from the pull-wire tubings).
Regarding claim 12, Tang discloses the catheter of claim 1, wherein the catheter includes one of a dilator and a guide catheter ([Abstract], [0002]: the invention is directed towards a catheter with a guiding sheath which are well known for facilitating a pathway for treatment or diagnostic catheters– i.e. the catheter is a guide catheter).
Regarding claim 14, Tang discloses the catheter of claim 1, wherein the electrode is a ring electrode ([0041]: electrodes 19 are ring electrodes).
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Tang as applied to claim 4/1 and described above, in view of Hoshino et al. (hereinafter ‘Hoshino’, US 20210353906 A1).
Regarding claim 5, Tang discloses the catheter of claim 4 as described above.
However, Tang is silent to the reinforcement member including a tubular coiled member having a plurality of second annular members attached to and spaced apart by a longitudinally extending coil.
Hoshino teaches a multilayer catheter with an outer layer, similar to the device of Tang ([Abstract]). The catheter further contains a coil embedded in the outer layer as seen in Fig. 2 ([0036]). The coil body provides a reinforcing layer and covers the reinforcing body 4- which is made of braid, similar to the device of Tang ([0037], [0038]). Utilizing a coil embedded in the outer layer aids in providing rigidity to the device which can be increased from the distal end towards the proximal end of the catheter ([0011]). Hoshino further teaches that embodiments can occur without such a coil as seen in Fig. 7, which is the same configuration as the device of Tang. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the coil taught by Hoshino with the device of Tang because Hoshino teaches that the device may or may not contain a coil depending on the desires of the user and that providing a coil in the outer layer provides for additional reinforcement around the braid along the length of the catheter.
However, the Tang/Hoshino combination is silent to this coil having annular members on each end.
It would have been an obvious matter of design choice to make the different portions of the coil of whatever form or shape was desired or expedient. In this specific case, attaching the ends of the coil to the adjacent piece, forming annular rings on both ends. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Furthermore, the instant application provides no criticality to this coil shape as it is merely one of several possible reinforcement member shapes as seen in Figs. 3A, 4A, 4B, and 5. The embodiment of Fig. 5 is especially relevant because it shows a thread coil wrapped around the catheter with no annular end rings, which is exactly like the coil disclosed in Hoshino.
Regarding claim 6, the Tang/Hoshino combination discloses the catheter of claim 5 as described above. Forming the reinforcement member from a laser machined tube is a product-by-process limitation. Even 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 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). In the instant case, forming a reinforcement coil from a laser machined tube is an obvious method of production to one of ordinary skill in the art for the coil of the reinforcement member in the combination. Furthermore, the instant application provides no criticality to this production method of the coil in the reinforcement member, stating that the coil can be formed from a laser machined tube or an extruded plastic tube ([0079]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the Tang as applied to claim 1 and described above, in view of Hoshino and in further view of Hori (US 20200353210 A1).
Regarding claim 8, Tang discloses the catheter of claim 1 of claim 1 as described above.
However, Hoshino is silent to the reinforcement layer including a thread wound around the tube and breakout section.
Hoshino teaches a multilayer catheter with an outer layer, similar to the device of Tang ([Abstract]). The catheter further contains a coil embedded in the outer layer as seen in Fig. 2 ([0036]). The coil body provides a reinforcing layer and covers the reinforcing body 4- which is made of braid, similar to the device of Tang ([0037], [0038]). Utilizing a coil embedded in the outer layer aids in providing rigidity to the device which can be increased from the distal end towards the proximal end of the catheter ([0011]). Hoshino further teaches that embodiments can occur without such a coil as seen in Fig. 7, which is the same configuration as the device of Tang. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the coil taught by Hoshino with the device of Tang because Hoshino teaches that the device may or may not contain a coil depending on the desires of the user and that providing a coil in the outer layer provides for additional reinforcement around the braid along the length of the catheter. Including the coil along the length of the shaft would also in turn cover the breakout section and the tube in Tang.
However, the Tang/Hoshino combination is silent to whether the coil is a threaded coil.
Hori teaches a catheter including a hollow shaft with a multi-layer thread coil covering the shaft ([Abstract]). The multi-thread coil body provides the effect of reinforcing the shaft and enhancing torquability ([0023]). The substitution of one known element (the threaded coil of Hori) for the (coil of the Hoshino/Tang combination) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the threaded coil shown in Hori would have yielded predictable results, namely, providing reinforcement to the catheter and enhancing torquability when using the catheter. Therefore, the resulting combination would result in the reinforcement member including a thread, which is part of the multi-thread coil, covering the length of the shaft which includes the breakout section and the tube.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the Tang as applied to claim 1 and described above, in view of Hsueh et al. (hereinafter ‘Hsueh’, US 20170106170 A1) and in further view of Azo Materials (hereinafter ‘Azo’, “An Introduction to PTFE and Thin-Walled Catheter Liners”).
Regarding claim 11, Tang discloses the catheter of claim 1, wherein the inner member includes an inner surface (inner surface of 25 in Fig. 3A). Tang further discloses that the inner member 25 can be made of any suitable material, including PTFE ([0043]).
However, Tang is silent to the inner member 25 including an additional inner liner layer.
Hsueh teaches a bi-directional steerable catheter adapted for delivery into a patient’s vasculature, similar to the device of Tang ([Abstract]). Also similar to the device of Tang, the catheter of Hsueh includes an inner tube 11, pull wires 12 and 13, a braid layer 14, and an outer tube 10 as seen in Fig. 4 ([0013]). Hsueh further teaches that the inner tube 11 can be made of PTFE or other polymers, just like the inner tube of Tang ([0014]). Hsueh also teaches that when the material of the inner tube is not PTFE, an inner PTFE liner 15 may be included as seen in Fig. 4 ([0014]).
Azo provides an introduction to PTFE catheter liners. Azo teaches that PTFE imparts chemical resistance and lubricity properties to the surfaces to which it coats ([PTFE Products and Catheter Componentry]). PTFE can be used on the inner walls of guiding catheters to provide a remarkably smooth surface which lowers friction against different catheter technologies which are introduced ([PTFE Products and Catheter Componentry]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the PTFE liner as taught by Hsueh with the non-PTFE inner member embodiment of Tang in order to provide enhanced lubricity to the inner surface of the member as taught by Azo.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the Tang as applied to claim 1 and described above.
Regarding claim 13, Tang discloses the catheter of claim 1, wherein the shaft includes a distal tip section having an ablation electrode assembly ([0041]: the device includes electrode assembly 19 on the distal tip section; while these electrodes are stated to be for sensing, they are also capable of ablation should an electrical signal be sent to them by the processor).
As written, “ablation” is simply intended use. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794
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