DETAILED ACTION
This action is pursuant to response filed on 7/30/2026. Claims 1-3, 5-10, and 12-20 are pending, claims 15-20 have been withdrawn in the Applicant’s response filed 4/3/2026 and claims 4 and 11 have been cancelled by the Applicant. A final action on the merits of claims 1-3, 5-10, and 12-14 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 .
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) 1-3, 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) longitudinally spaced apart a breakout section (breakout section J in Fig. 1; this is the area of the support member where the tubing go from under the braided layer to above the braided layer; [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 and the proximal portion are separated by the area that forms the breakout section; the claim requires these portions to be made of the same support member so they must stay connected and not be separate pieces), 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 at the breakout section (disposed at 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), the reinforcement member having a tubular longitudinal surface (the inner surface of the layer 48 is tubular as seen in Fig. 3A), 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 portion and the distal portion 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 7, Tang discloses the catheter of claim 1, wherein an opening of the reinforcement member is formed on the tubular longitudinal surface (opening through which tube 40 is residing in Fig. 3A and 3B – an opening formed on the tubular longitudinal surface 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 elongated 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 1 and described above, in view of Hoshino et al. (hereinafter ‘Hoshino’, US 20210353906 A1).
Regarding claim 5, Tang discloses the catheter of claim 1 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, Tang 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 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 elongated 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.
Response to Arguments
Applicant’s arguments, filed 7/30/2026 in regards to the drawing objections have been fully considered and are persuasive in light of claim 11 being cancelled. The objections to the drawings have been withdrawn.
Applicant’s arguments, filed 7/30/2026 regarding the 112b rejections of claims 3-7, 9, and 13 have been fully considered and are persuasive in light of the amendments. The 112b rejections of claims 3-7, 9, and 13 have been withdrawn.
Applicant’s arguments regarding the 102 rejection of claim 1 have been fully considered but are not persuasive.
The applicant initially argues that Tang does not disclose the proximal and distal portions of the support member being longitudinally spaced apart at a breakout section. The applicant argues that the claim requires these portions to be separate entities. However, the claim does not require that. The claim only requires proximal and distal portions spaced apart at a breakout section. The proximal and distal areas of the braided layer of Tang are separated by a breakout section where the junction J is located. The claim does not provide any specific structure to these sections, how long they must be, or if the support member must be completely discontinuous at the breakout section. As broadly claimed, these portions can simply be different sections of a continuous member, which is the case of Tang where the proximal portion and the distal portion are separated by a portion where the tubing extends from underneath the braid to over the braid.
Applicant additionally argues that Tang fails to show the reinforcement member having a tubular longitudinal surface. However, this is not persuasive. The inner and outer surfaces of layer 48 are clearly tubular as seen in Figs. 2, 3, 7, and 8. Applicant argues that since the outer layer is a reflowed coating, it cannot be tubular. However, it forms a tubular shape as shown in the figures and is called an outer layer repeatedly ([0053]). Additionally, the proximal and distal ends of the reinforcement member are coupled to the proximal and distal portions of the support member because the layer is disposed around the entirety of layer 26 as shown in Figs. 2 and 3A which show the reinforcement layer 48 being present both before and after the breakout section.
Therefore, the rejection of claim 1 remains.
Applicant’s arguments regarding claim 7 have been fully considered but are not persuasive. The applicant argues that Tang does not teach the claimed opening because the outer layer is applied over the tubing. However, this is not persuasive. The claim is not specific to the opening going through the reinforcement layer. Only that an opening is formed on the tubular surface. As seen in Figs. 2 and 3, the reinforcement layer provides an opening after the breakout section that the tubing can reside in. This opening is on and along the inner surface which is tubular since it is shaped like a tube. The open space that the tubings 30 and 40 occupy are both openings along the surface. The method through which the layer and opening are formed is inconsequential because the claim is not specific to what the reinforcement layer is or in what direction the opening is formed.
Therefore, claim 7 remains rejected.
Dependent claims 2-3, 6, 9-10, 12, and 14 remain rejected because claim 1 remains rejected.
Applicant’s arguments regarding claim 5 have been fully considered but are not persuasive. The applicant argues that it would not have been obvious to modify the shape of the ends of the coil to form annular members because the rings are critical. However, this is not persuasive. Attaching the ends of the coil to the adjacent piece, forming annular rings on both ends, is an extremely simple change of shape. 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, this shape is not critical as the applicant argues because 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.
Therefore, claim 5 remains rejected.
Applicant’s arguments regarding claim 8 have been fully considered but are not persuasive. Claim 8 does not claim an elongated lead-conductor tube transitioning at a breakout section between longitudinally spaced support member portions. Tang addresses those limitations as described above. Claim 8 simply claims that a thread is wound around the tube and breakout section. The Tang/Hoshino/Hori combination of claim 8 described above clearly teaches a threaded coil wrapped in the claimed manner. A threaded coil has threads and thus the claim limitation is met.
Therefore, claim 8 remains rejected.
Applicant’s arguments regarding claim 13 have been fully considered but are not persuasive because claim 1 remains rejected and thus claim 13 remains rejected.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
