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 .
Response to Arguments
Applicant’s arguments, see page 1, filed on 2/25/2026, with respect to the drawing objections have been fully considered and are persuasive. The previous drawing objections have been withdrawn.
Applicant’s arguments, see page 1, filed on 2/25/2026, with respect to the specification objections have been fully considered and are persuasive. The previous specification objections have been withdrawn.
Applicant’s arguments, see page 1, filed on 2/25/2026, with respect to the claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant’s arguments, see page 2, filed on 2/25/2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
Applicant’s arguments, see pages 2-4, filed on 2/25/2026, with respect to the rejections of claims 1-6 and 8-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Tang and Lentz.
Applicant’s arguments, see page 4, filed on 2/25/2026, with respect to the rejection of claim 7 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Tang and Jansen.
Applicant's arguments filed on 2/25/2026 regarding the double patenting rejections have been fully considered. However, the double patenting rejections of claims 3, 8, and 20 are upheld.
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, 6, and 8-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tang et al. (U.S. Patent No. 11,534,078).
Regarding claim 1, Tang teaches a catheter (Col. 4, line 16), comprising: an elongated shaft (Col. 4, lines 16-17) defining a lumen (Col. 4, line 46) and having a distal portion (Col. 4, line 19), the elongated shaft having an outermost elongated support member (Col. 4, line 53) coaxial with the lumen (Fig. 3A-3B), the support member having an outer side (Col. 4, line 60); an electrode (Col. 4, line 21) disposed on the distal portion of the elongated shaft (Fig. 6); an elongated tube (Fig. 4, Col. 5, line 26) extending longitudinally along the elongated shaft (Fig. 4, Col. 5, line 25), the elongated tube coupled to the support member along the outer side (Fig. 4, Col. 5, lines 36-37); a lead conductor (Fig. 4, Col. 5, line 27) disposed within the tube (Col. 5, lines 26-27) and electrically coupled to the electrode (Col. 5, lines 27-29); and a coupling member (Col. 4, lines 57-58) disposed about the tube and outer side of the support member (Fig. 4, Col. 4, lines 57-62), the coupling member coupling the tube to the support member (Fig. 4).
Regarding claim 6, Tang teaches the catheter (Col. 4, line 16) of claim 1, wherein the shaft (Col. 4, lines 16-17) includes a cover (Fig. 4, Col. 6, lines 8-10) disposed on the coupling member, tube, and support member (Col. 6, lines 14-16).
Regarding claim 8, Tang teaches the catheter (Col. 4, line 16) of claim 1, wherein the elongate tube (Fig. 4, Col. 5, line 26) includes a plurality of elongate tubes (Col. 5, lines 29-30) radially spaced-apart on the outer side (Col. 5, lines 30-31).
Regarding claim 9, Tang teaches the catheter (Col. 4, line 16) of claim 1, wherein the support member (Col. 4, line 53) is a liner layer (Col. 4, line 60).
Regarding claim 10, Tang teaches the catheter (Col. 4, line 16) of claim 1, wherein the coupling member (Col. 4, lines 57-58) includes one or more coils (Fig. 4) wound around the elongated tube and support member (Fig. 4).
Regarding claim 11, Tang teaches the catheter (Col. 4, line 16) of claim 10, wherein the coupling member (Col. 4, lines 57-58) includes a first coil (See Annotated Fig. 4) and a second coil (See Annotated Fig. 4), the first coil wound in a first direction along a length of the support member (See Annotated Fig. 4) and the second coil wound in a second direction along the length of the support member (See Annotated Fig. 4), the second direction opposite the first direction (See Annotated Fig. 4).
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Annotated Fig. 4
Regarding claim 12, Tang teaches the catheter (Col. 4, line 16) of claim 10, wherein the elongated tube (Fig. 4, Col. 5, line 26) transitions from under to over (Fig. 3A and 4, Col. 5, lines 33-37) the coupling member (Col. 4, lines 57-58) on the support member (Col. 4, line 53).
Regarding claim 13, Tang teaches a method of manufacturing (Col. 7, lines 1-2) a
catheter (Col. 4, line 16), the method comprising: providing an elongated outermost support member (Col. 4, line 53) of a shaft (Col. 4, lines 16-17) defining a lumen (Col. 4, line 46), the support member having an outer side (Col. 4, line 60); and attaching an elongated tube (Fig. 4, Col. 5, line 26) extending longitudinally along the elongated outermost support member (Fig. 4, Col. 5, line 25); wherein the attaching includes winding a coupling member (Col. 4, lines 57-58) around the elongated tube and outer side of the support member (Fig. 4, Col. 4, lines 57-62), a thread coupling the elongated tube to the support member (Fig. 4).
Regarding claim 14, Tang teaches the method (Col. 7, lines 1-2) of claim 13, further including interfacing the elongated tube (Fig. 4, Col. 5, line 26) with the elongated
outermost support member (Col. 4, line 53) only along the outer side (Fig. 3A-4).
Regarding claim 15, Tang teaches the method (Col. 7, lines 1-2) of claim 13, further comprising disposing a mandrel (Col. 5, lines 62-64) within the elongated tube (Fig. 4, Col. 5, line 26) prior to winding the coupling member (Col. 4, lines 57-58).
Regarding claim 16, Tang teaches the method (Col. 7, lines 1-2) of claim 13, wherein the elongated tube (Fig. 4, Col. 5, line 26) includes a tube distal end (Col. 6, lines 48-49), wherein the tube distal end is closed (Col. 4, lines 9-10) prior to (Col. 6, lines 14-16) a cover (Fig. 4, Col. 6, lines 8-10) being applied.
Regarding claim 17, Tang teaches the method (Col. 7, lines 1-2) of claim 16,
wherein the tube distal end (Col. 6, lines 48-49) is closed (Col. 4, lines 9-10) via the
coupling member (Col. 4, lines 57-58) winding around the tube distal end and the outer side (Fig. 3A-3B) of the support member (Col. 4, line 53).
Regarding claim 18, Tang teaches the method (Col. 7, lines 1-2) of claim 17, wherein the cover (Fig. 4, Col. 6, lines 8-10) is applied via a reflow process (Col. 6, lines 10-12).
Regarding claim 19, Tang teaches a system for tracking (Col. 1, lines 7-10) a
catheter (Col. 4, line 16) during an electrophysiology procedure (Col. 1, line 9) on a
patient (Col. 4, line 26), the system comprising: a patch electrode (Col. 4, line 29)
mechanically couplable to the patient (Col. 4, lines 29-30); a catheter disposable within
the patient (Col. 4, line 26), the catheter comprising: an elongated shaft (Col. 4, lines 16-
17) defining a lumen (Col. 4, line 46) and having a distal portion (Col. 4, line 19), the
elongated shaft having an outermost elongated support member (Col. 4, line 53) coaxial with the lumen (Fig. 3A-3B), the support member having an outer side (Col. 4, line 60); a tracking electrode (Col. 4, line 21) disposed on the distal portion of the elongated shaft (Col. 6, lines 47-49), the tracking electrode configured to electrically couple with the patch electrode (Col. 4, lines 28-29) and generate an electrical signal (Col. 4, lines 28-29); an elongated tube (Fig. 4, Col. 5, line 26) extending longitudinally along the elongated shaft (Fig. 4, Col. 5, line 25), the elongated tube interfacing with the support member along the outer side (Fig. 4, Col. 5, lines 36-37); a lead conductor (Fig. 4, Col. 5, line 27) disposed within the tube (Fig. 4, Col. 5, lines 26-27) and electrically coupled to the tracking electrode (Col. 5, lines 27-29), the lead conductor configured to deliver the electrical signal (Col. 5, lines 27-29); and a coupling member (Col. 4, lines 57-58) disposed about the tube and outer side of the support member (Fig. 4, Col. 4, lines 57-62), the coupling member coupling the tube to the support member (Fig. 4); and a controller (Col. 6, line 44) operably coupled to the patch electrode and the tracking electrode (Col. 6, lines 44-45), the controller configured to receive the electrical signal (Col. 4, line 24) and determine a position of the catheter (Col. 4, lines 25-26) with respect to the patient.
Regarding claim 20, Tang teaches the system (Col. 1, lines 7-10) of claim 19, wherein the controller (Col. 6, line 44) is further configured to generate an electroanatomical map of a heart (Col. 1, lines 31-32 and Col. 2, lines 11-15) of the patient (Col. 4, line 26).
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 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (U.S. Patent No. 11,534,078) in view of Lentz et al. (WIPO Pub. No. 2024/054938) (both cited previously).
Regarding claim 2, Tang teaches the catheter (Col. 4, line 16) of claim 1 that
comprises the support member (Col. 4, line 53). Tang does not teach that the support member includes a braided material forming a braided member. Lentz, however, teaches a catheter that comprises an elongated shaft (Fig. 1, Paragraph 0040, line 1, 102) and a support member (Paragraph 0031, lines 1-3) that includes a braided material (Paragraph 0045, line 10) forming a braided member (Fig. 1, Paragraph 0040, line 2, 134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang to incorporate the teachings of Lentz to include that the support member is a braided member. Doing so would increase the strength, stiffness, burst strength, and creep resistance of the shaft (Paragraph 0031), as recognized by Lentz.
Regarding claim 3, Tang teaches the catheter (Col. 4, line 16) of claim 2. Tang does not teach that the braided member includes conductive fibers. Lentz, however, teaches a catheter that comprises an elongated shaft (Fig. 1, Paragraph 0040, line 1, 102) and a support member (Paragraph 0031, lines 1-3) that includes a braided member (Fig. 1, Paragraph 0040, line 2, 134). Furthermore, Lentz teaches that the braided member is made of conductive (Paragraph 0057, lines 3-4) fibers (Paragraph 0064, lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang to incorporate the teachings of Lentz to include that the braided member is made of conductive fibers. Doing so would allow the braided member to return to its original shape despite deflection, deformation, and twisting (Paragraph 0064), as recognized by Lentz.
Regarding claim 4, Tang in view of Lentz discloses the claimed invention of claim 3. Tang further discloses the catheter (Col. 4, line 16) of claim 3, wherein the coupling member (Col. 4, lines 57-58) is a thread (Fig. 4).
Regarding claim 5, Tang teaches the catheter (Col. 4, line 16) of claim 1, wherein the elongate tube (Fig. 4, Col. 5, line 26) traverses into the lumen through the support member (Col. 5, lines 32-34) on a proximal side of the shaft (Col. 5, lines 32-34). Tang does not teach that the support member includes a braided member. Lentz, however, teaches a catheter that comprises an elongated shaft (Fig. 1, Paragraph 0040, line 1, 102) and a support member (Paragraph 0031, lines 1-3) that includes a braided member (Fig. 1, Paragraph 0040, line 2, 134).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang to incorporate the teachings of Lentz to include that the support member is a braided member. Doing so would increase the strength, stiffness, burst strength, and creep resistance of the shaft (Paragraph 0031), as recognized by Lentz.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (U.S. Patent No. 11,534,078) in view of Jansen et al. (WIPO Pub. No. 2021/183444).
Regarding claim 7, Tang teaches the catheter (Col. 4, line 16) of claim 6, wherein the cover (Fig. 4, Col. 6, lines 8-10) includes a polyether block amide (Col. 6, line 19). Tang does not teach that the coupling member includes a nylon thread. Jansen, however, teaches an enhanced flexibility neurovascular catheter (Fig. 4, Paragraph 0072, line 1, 3000) that includes a coil (Fig. 4, Paragraph 0073, line 3, 3024) that wraps around an inner liner (Fig. 4, Paragraph 0073, lines 4-5, 3014). Jansen further teaches that the coil includes threads (Fig. 4) and can be made of nylon (Paragraph 0125, lines 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tang to incorporate the teachings of Jansen to include that the coupling member includes a nylon thread. Doing so would provide kinking resistance for the catheter (Paragraph 0090), as recognized by Jansen.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 3 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 3 of co-pending Application No. 18/626,677 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 3 of Kacha '677 recites a catheter (Page 10, line 1) of claim 2, wherein the braided member (proximal braided member and distal
braided member, page 10, lines 2-3) includes conductive fibers (page 10, lines 2-3).
Therefore, patent claim 3 of Kacha '677 is in essence a "species" of the generic invention of application claim 3. It has been held that a generic invention is "anticipated" by a "species" within the scope of the generic invention.
This is a provisional non-statutory double patenting rejection because the
patentably indistinct claims have not in fact been patented.
Claim 8 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 10 of co-pending Application No. 18/626,677 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 10 of Kacha '677 recites a catheter (Page 10, line 1) of claim 1, wherein the elongate tube (Page 10, line 1) includes a plurality of elongate tubes (Page 10, line 2) radially spaced-apart (Page 10, line 2) on the outer side (of the distal portion, page 10, line 3). Therefore, patent claim 10 of Kacha '677 is in essence a "species" of the generic invention of application claim 8. It has been held that a generic invention is "anticipated" by a "species" within the scope of the generic invention.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 20 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 18 of co-pending Application No. 18/626,677 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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