DETAILED ACTION
This action is pursuant to the claims filed on 08/24/2026. Claims 1-3 and 5-14 are pending. A first action on the merits of claims 1-3 and 5-14 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
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.
(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, 11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ditter (U.S. PGPub No. 2013/0006238).
Regarding claim 1, Ditter teaches An electrophysiology catheter comprising: an elongated catheter body (Fig 1 catheter body 12); a contraction wire having a proximal end and a distal end (Fig 6 contraction wire 44 has proximal and distal ends); and a distal assembly configured for contraction by actuation of the contraction wire (Fig 11 support member 50; [0057]), the distal assembly comprising a lumen (Fig 11 lumen 30), a radially constrictive tubing disposed in the lumen (Fig 11, braided polyimide tubing 62), a portion of the contraction wire disposed in the radially constrictive tubing ([0057] Fig 11 contraction wire 44 in tubing 62), and a shape-memory support member disposed in the radially constrictive tubing (Fig 11 shape memory support member 50; [0056]), such that the radially constrictive tubing provides a radially constrictive tight fit around the shape-memory support member and the portion of the contraction wire (Fig 11, braided polyimide tubing 62 surrounds support member 50 and contraction wire 44 with a radially constrictive tight fit (i.e., the member 50 and wire 44 cannot protrude outside of tubing 62) [0073] discloses this radially constrictive tight fit of the tubing 62).
Regarding claim 11, in view of claim 1 above, Ditter further teaches a first ferrule attached to a distal end of the support member ([0073] Fig 12, support member 50 attached to steel tube 63 at distal end; steel tube 63 interpreted as a ferrule given that it defines and end cap to strengthen the end of the catheter), a second ferrule attached to the distal end of the contraction wire and to the first ferrule (Fig 12 [0073] crimped ferrule 51 is attached to distal end of contraction wire 44 and the steel tube 61).
Regarding claim 13, in view of claim 1 above, Ditter further teaches in which the radially constrictive tubing comprises an inner diameter composed of a friction-reducing material ([0072] inner layer of tubing 62 is a polyimide layer which is interpreted as friction-reducing compared to the adjacent braided stainless steel mesh).
Regarding claim 14, in view of claim 1 above, Ditter further teaches in which the shape-memory support member and the portion of the contraction wire are bound together by the radially constrictive tight fit of the radially constrictive tubing (Fig 11, tubing 62 forces the wire 44 and support member 50 to be bound together given the two of 44/50 occupy the entire diameter of the tubing 62 such that there is no space to be ‘unbound’).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 2-3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Parisi (U.S. PGPub No. 2001/0027310).
Regarding claim 2, in view of the combination of claim 1 above.
Ditter fails to teach wherein the radially constrictive tubing includes manufactured fibers formed from a liquid crystal polymer.
In related catheter prior art, Parisi teaches a tubing comprising a liquid crystal polymer ([0035]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the radially constrictive tubing of Ditter to incorporate a fiber formed from a liquid crystal polymer to arrive at the catheter of claim 2. Doing so would have advantageously increased the torqueability of the radially constrictive tubing ([0035]).
Regarding claim 3, in view of the combination of claim 2 above. Ditter further teaches in which the manufactured fibers are braided such that the radially constrictive tubing has a braided construction (Fig 11 braided tubing 62 as disclosed in [0070]).
Regarding claims 6, Ditter further teaches in which the fibers are woven such that the radially constrictive tubing has a woven construction. ([0072] tubing 62 is braided; examiner notes that braided is interpreted to be the same as woven).
Claims 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Parisi, and Poole (U.S. PGPub No. 2004/0181208).
Regarding claim 5, in view of the combination of claim 3 above.
Ditter is silent to the PPI of the braided construction.
In related catheter prior art, Poole teaches a catheter with a similar braided construction and teaches that providing the braided construction with a PPI from 50 to 150 advantageously increases “flexibility and kink resistance” ([0029]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the braided construction of Ditter in view of Poole to incorporate a braided construction at 128 PPI. Doing so would advantageously increase the flexibility and kink resistance of the braided construction ([0029]).
The combination discloses substantially all the limitations of the claim(s) except for the exact PPI of 128. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide a PPI of the braided construction at 128 to optimize the flexibility and kink resistance, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Parisi, and Grasse (U.S. PGPub No. 2013/0338467).
Regarding claims 7-8, in view of the combination of claim 2 above.
Ditter fails to teach wherein the radially-constrictive tubing is transparent or translucent.
In related catheter prior art, Grasse teaches a similar electrophysiology catheter (Fig 1) wherein a tubing is formed to be translucent or transparent ([0062]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the radially constrictive tubing of Ditter in view of Grasse to incorporate translucence or transparency to the radially constrictive tubing as taught by Grasse to arrive at the catheters of claims 7-8. Doing so would allow a user to locate the contraction wire and support member in the tubing during use and/or construction of the catheter (Grasse [0062]).
Claims 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Gardeski (U.S. PGPub No. 2004/0116848).
Regarding claim 9, Ditter teaches the device of claim 1 as stated above.
Ditter fails to explicitly teach the radially constrictive tubing being fused to the lumen.
In related prior art, Gardeski teaches a similar device wherein a similar radially constrictive tubing is fused to a similar lumen ([0063] and Fig 12 sheath 34 is fused with braid tubing 28). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the radially constrictive tubing of Ditter in view of Gardeski to incorporate the tubing fused to the lumen to arrive at claim 9. Doing so would be obvious to one of ordinary skill in the art to advantageously anchor the radially constrictive tubing to the lumen to secure the tubing in place (Gardeski [0063]; Ditter disclosing tubing 62 anchored, but not fused in [0073]).
Claims 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter.
Regarding claim 10, Ditter teaches the device of claim 1 above. An alternative embodiment of Ditter teaches wherein the shape memory support member comprises a generally rectangular cross-sectional shape the shape memory support member comprises a generally rectangular cross-sectional shape ([0069] support member 50 may have a generally circular or rectangular cross section) such that the portion of the contraction wire is disposed adjacent to a flat side surface of the shape-memory support member. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support member of Ditter to be rectangular such that the contraction wire is adjacent to a flat side surface of the support member to arrive at claim 10. Providing the support member as rectangular would be advantageously provide the support member with greater stiffness relative to a circular shape ([0069]).
Claims 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of O’Boyle (U.S. PGPub No. 2003/0208252).
Regarding claim 12, Ditter teaches the device of claim 1.
Ditter fails to teach a friction-reducing tubing covering the portion of the contraction wire.
In related prior art, O’Boyle teaches a device in which a steering tube has a friction-reducing tubing covering ([0055] lubricious sleeve such as Teflon is bonded to steering wire 38 to reduce frictional forces imparted by the walls of lumens). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portion of contraction wire of Ditter in view of O’Boyle to incorporate a lubricious coating of Teflon to arrive at claim 12. Doing so would advantageously reduce the friction forces imparted on the walls of the tubing ([0055]).
Double Patenting
The nonstatutory 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 nonstatutory 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.
Claims 1-3, 5-10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,918,832 in view of Gardeski. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the reference claims.
Claim 11 and 13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,918,832 in view of Gardeski and Ditter.
Regarding claims 11 and 13, Ditter teaches a first ferrule attached to a distal end of the support member ([0073] Fig 12, support member 50 attached to steel tube 63 at distal end; steel tube 63 interpreted as a ferrule given that it defines and end cap to strengthen the end of the catheter), a second ferrule attached to the distal end of the contraction wire and to the first ferrule (Fig 12 [0073] crimped ferrule 51 is attached to distal end of contraction wire 44 and the steel tube 61); in which the radially constrictive tubing comprises an inner diameter composed of a friction-reducing material ([0072] inner layer of tubing 62 is a polyimide layer which is interpreted as friction-reducing compared to the adjacent braided stainless steel mesh). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference patent in view of Ditter to incorporate the first and second ferrule as claimed as well as the inner diameter of polyimide of the radially constrictive tubing as claimed. Doing so would advantageously increase the strength and stabilization of the catheter device as is known in the art with the use of ferrules. Providing the friction reducing material advantageously would reduce the friction experienced within the tubing of the device.
Claim 12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,918,832 in view of Gardeski and O’Boyle.
Regarding claim 12, O’Boyle teaches a device in which a steering tube has a friction-reducing tubing covering ([0055] lubricious sleeve such as Teflon is bonded to steering wire 38 to reduce frictional forces imparted by the walls of lumens). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portion of contraction wire of Ditter in view of O’Boyle to incorporate a lubricious coating of Teflon to arrive at claim 12. Doing so would advantageously reduce the friction forces imparted on the walls of the tubing ([0055]).
Claims 1-3, 5-10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,872,358 in view of Gardeski and Grasse. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the reference claims.
Claim 11 and 13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,872,358 in view of Gardeski, Grasse and Ditter.
Regarding claims 11 and 13, Ditter teaches a first ferrule attached to a distal end of the support member ([0073] Fig 12, support member 50 attached to steel tube 63 at distal end; steel tube 63 interpreted as a ferrule given that it defines and end cap to strengthen the end of the catheter), a second ferrule attached to the distal end of the contraction wire and to the first ferrule (Fig 12 [0073] crimped ferrule 51 is attached to distal end of contraction wire 44 and the steel tube 61); in which the radially constrictive tubing comprises an inner diameter composed of a friction-reducing material ([0072] inner layer of tubing 62 is a polyimide layer which is interpreted as friction-reducing compared to the adjacent braided stainless steel mesh). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference patent in view of Ditter to incorporate the first and second ferrule as claimed as well as the inner diameter of polyimide of the radially constrictive tubing as claimed. Doing so would advantageously increase the strength and stabilization of the catheter device as is known in the art with the use of ferrules. Providing the friction reducing material advantageously would reduce the friction experienced within the tubing of the device.
Claim 12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,872,358 in view of Gardeski, Grasse and O’Boyle.
Regarding claim 12, O’Boyle teaches a device in which a steering tube has a friction-reducing tubing covering ([0055] lubricious sleeve such as Teflon is bonded to steering wire 38 to reduce frictional forces imparted by the walls of lumens). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portion of contraction wire of Ditter in view of O’Boyle to incorporate a lubricious coating of Teflon to arrive at claim 12. Doing so would advantageously reduce the friction forces imparted on the walls of the tubing ([0055]).
Claims 1-3, 5-10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,161,817 in view of Gardeski and Grasse. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated and/or made obvious by the reference claims.
Claim 11 and 13 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,161,817 in view of Gardeski, Grasse and Ditter.
Regarding claims 11 and 13, Ditter teaches a first ferrule attached to a distal end of the support member ([0073] Fig 12, support member 50 attached to steel tube 63 at distal end; steel tube 63 interpreted as a ferrule given that it defines and end cap to strengthen the end of the catheter), a second ferrule attached to the distal end of the contraction wire and to the first ferrule (Fig 12 [0073] crimped ferrule 51 is attached to distal end of contraction wire 44 and the steel tube 61); in which the radially constrictive tubing comprises an inner diameter composed of a friction-reducing material ([0072] inner layer of tubing 62 is a polyimide layer which is interpreted as friction-reducing compared to the adjacent braided stainless steel mesh). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference patent in view of Ditter to incorporate the first and second ferrule as claimed as well as the inner diameter of polyimide of the radially constrictive tubing as claimed. Doing so would advantageously increase the strength and stabilization of the catheter device as is known in the art with the use of ferrules. Providing the friction reducing material advantageously would reduce the friction experienced within the tubing of the device.
Claim 12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,161,817 in view of Gardeski, Grasse and O’Boyle.
Regarding claim 12, O’Boyle teaches a device in which a steering tube has a friction-reducing tubing covering ([0055] lubricious sleeve such as Teflon is bonded to steering wire 38 to reduce frictional forces imparted by the walls of lumens). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the portion of contraction wire of Ditter in view of O’Boyle to incorporate a lubricious coating of Teflon to arrive at claim 12. Doing so would advantageously reduce the friction forces imparted on the walls of the tubing ([0055]).
Response to Arguments
Applicant's arguments filed 08/24/2026 have been fully considered but they are not persuasive.
Applicant argues Ditter fails to teach the constrictive tubing 62 “provides a radially constrictive tight fit around the shape-memory support member and the portion of the contraction wire.” Applicant highlights the differences in Figure 8 of the instant application and Figure 11 of Ditter on page 3 of the remarks.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., structural difference of instant Fig 8 and Fig 11 of Ditter) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, the tubing 62 of Ditter clearly and explicitly forms a “radially constrictive tight fit” around the support member 50 and contraction wire 44 as disclosed in at least paras. [0072-0073]. The Examiner is of the position that the claims as presented are broader in scope than Applicant’s Figure 8. As such, these arguments are unpersuasive.
Applicant’s remaining arguments are unpersuasive for the reasons stated above.
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 Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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.
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
Prosecution Insights