DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/3/2025 has been entered.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
5. Claim 38 is objected to because of the following informalities: lines 3-4 currently recite “…comprising a plurality of comprising optical conduits…”. It is assumed these lines are meant to recite “… comprising a plurality of cores comprising optical conduits…”. Appropriate correction is required.
6. Claim 40 is objected to because of the following informalities: “multicore fiber” is recited, which is missing a hyphen, such as “multi-core fiber”, like recited in Claim 38. Appropriate correction is required.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 21-23, 26-27, 29-31, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Park U.S. 8,649,847 (herein referred to as “Park”) and in view of Eberle U.S. 10,258,240 (herein referred to as “Eberle”).
9. Regarding Claim 21, Park teaches a tip assembly (Fig. 1, ref num 100), comprising:
a. a flex tip (Fig. 1, ref nums 120, 122, 114) comprising a cap (Fig. 1, ref num 114);
b. a fiber support tube (Fig. 6C, ref num 650);
c. at least one fiber support tube center (Fig. 6C, ref num 654);
d. a multi-core fiber comprising a plurality of cores (Fig. 6C, ref nums 656, 658, 660) and disposed within the fiber support tube (see Figs. 6C, 6D, 6F, ref nums 656, 658, 660 are disposed within ref num 650), the plurality of cores comprising optical conduits for respective shape sensing sensors (Fig. 6D, ref nums 664, 666, 668; Col. 5, lines 34-42);
Park fails to teach wherein the at least one fiber support tube center defines an aperture therethrough that receives the distal portion of the fiber support tube and a distal portion of the multi-core fiber within the distal portion of the fiber support tube and secures the distal portion of the fiber support tube and the distal portion of the multi-core fiber in place within the flex tip.
Eberle teaches a tip assembly of analogous art (Fig. 1, 29A) wherein the tip comprises a multi-core fiber (Fig. 29A, ref num 2916) disposed within a fiber support tube (Fig. 29A, ref num 2910). The tip also comprises a fiber support tube center (Fig. 29A, ref num 2908), such that the at least one fiber support tube center defines an aperture therethrough that receives the distal portion of the fiber support tube (see Fig. 29A, an aperture defined through ref num 2908 receives ref num 2910) and a distal portion of the multi-core fiber within the distal portion of the fiber support tube (see Fig. 29A) and secures the distal portion of the fiber support tube and the distal portion of the multi-core fiber in place within the flex tip (Col. 51, lines 57-64, “distal ferrule 2906 such that the optical fiber can extend from a periphery of the guidewire body to and through a center axis lumen of the distal ferrule 2906; and (2) a proximal portion that can include a connector housing 2908 carrying a ceramic or other proximal ferrule 2910, a split sleeve ferrule guide 2912, and a distal receptacle guide 2914 that can provide a tapered portion into which a portion of the distal ferrule 2906 and the metal tube 2904 can be received”). This configuration provides a desirable alignment between the cores of the optical fibers and the electrical connections in order to minimize optical losses (Col. 51, lines 34-44). 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 Park to have the at least one fiber support tube center receive the distal potion of the fiber support tube and distal portion of the multi-core fiber in order to promote a desirable connection and minimize optical loss.
10. Regarding Claim 22, Park teaches each of the plurality of cores comprise a plurality of fiber Bragg gratings (Col. 4, lines 31-33, “plurality of optical fibers with fiber Bragg gratings (FBG) placed co-axially”).
11. Regarding Claim 23, Park teaches the plurality of cores configured to provide optical conduits for respective shape sensing sensors comprise three cores spaced at 120 degrees from one another (Col. 5, lines 5-8, “has a plurality of grooves which contain fibers…provides an angular spacing about central axis… such as 120 degrees (as shown)”; see Figs. 6B and 6D).
12. Regarding Claim 26, Park fails to teach the at least one fiber support tube center is integral with the cap of the flex tip.
Eberle teaches the at least one fiber support tube center is integral with the cap of the flex tip (Fig. 29A, 2908 is integral with ref num 2902). This configuration provides a desirable alignment between the cores of the optical fibers and the electrical connections in order to minimize optical losses (Col. 51, lines 34-44). 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 Park to have the at least one fiber support tube center is integral with the cap of the flex tip in order to promote a desirable connection and minimize optical loss.
13. Regarding Claim 27, Park teaches a coupler coupled to proximal portion of the flex tip (Fig. 6C, ref nums 652, 662, understood that one of these end supports would be coupled to the proximal portion of the flex tip).
14. Regarding Claims 29 and 30, Park fails to teach the at least one fiber support tube center of the flex tip comprises a first fiber support tube center and the coupler comprises a second fiber support tube center, such that the second fiber support tube center is configured to center the fiber support tube within the flex tip.
Eberle teaches the at least one fiber support tube center of the flex tip comprises a first fiber support tube center and the coupler comprises a second fiber support tube center (Fig. 29A, ref nums 2908, 2914 define two fiber support tube centers), such that the second fiber support tube center is configured to center the fiber support tube within the flex tip (see Fig. 29A, ref num 2910 is centered within the flex tip). This configuration provides a desirable alignment between the cores of the optical fibers and the electrical connections in order to minimize optical losses (Col. 51, lines 34-44). 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 Park to have a first and second fiber support tube centers to center the fiber support tube in order to promote a desirable connection and minimize optical loss.
15. Regarding Claim 31, Park teaches the fiber support tube further comprises a support tube slot (Fig. 6B, ref num 614) configured to allow the fiber support tube to flex (Fig. 6B and 6H; Col. 6, line 20).
16. Regarding Claim 38, Park teaches a tip assembly (Fig. 1, ref num 100), comprising:
a. a fiber support tube (Fig. 6C, ref num 650);
b. a multi-core fiber comprising a plurality of cores (Fig. 6C, ref nums 656, 658, 660) and within the fiber support tube (see Figs. 6C, 6D, 6F, ref nums 656, 658, 660 are disposed within ref num 650), the plurality of cores comprising optical conduits for respective shape sensing sensors (Fig. 6D, ref nums 664, 666, 668; Col. 5, lines 34-42);
c. at least one fiber support tube center (Fig. 6C, ref num 654);
d. a coupler (Fig. 6C, ref nums 652, 662), wherein the at least one fiber tube center is disposed within an interior portion of the coupler (Figs. 6C and 6D, ref num 654 is in the interior portion of 652, 662);
e. a tip electrode coupled to a distal portion of the coupler (Fig. 1, ref nums 120, 122, 114; Fig. 6A, the shaft in which the coupler is coupled to the tip electrode).
Park fails to teach wherein the at least one fiber support tube center defines an aperture therethrough that receives the distal portion of the fiber support tube and a portion of the multi-core fiber within the distal portion of the fiber support tube.
Eberle teaches a tip assembly of analogous art (Fig. 1, 29A) wherein the tip comprises a multi-core fiber (Fig. 29A, ref num 2916) disposed within a fiber support tube (Fig. 29A, ref num 2910). The tip also comprises a fiber support tube center (Fig. 29A, ref num 2908), such that the at least one fiber support tube center defines an aperture therethrough that receives the distal portion of the fiber support tube (see Fig. 29A, an aperture defined through ref num 2908 receives ref num 2910) and a distal portion of the multi-core fiber within the distal portion of the fiber support tube (see Fig. 29A) and secures the distal portion of the fiber support tube and the distal portion of the multi-core fiber in place within the flex tip (Col. 51, lines 57-64, “distal ferrule 2906 such that the optical fiber can extend from a periphery of the guidewire body to and through a center axis lumen of the distal ferrule 2906; and (2) a proximal portion that can include a connector housing 2908 carrying a ceramic or other proximal ferrule 2910, a split sleeve ferrule guide 2912, and a distal receptacle guide 2914 that can provide a tapered portion into which a portion of the distal ferrule 2906 and the metal tube 2904 can be received”). This configuration provides a desirable alignment between the cores of the optical fibers and the electrical connections in order to minimize optical losses (Col. 51, lines 34-44). 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 Park to have the at least one fiber support tube center receive the distal potion of the fiber support tube and distal portion of the multi-core fiber in order to promote a desirable connection and minimize optical loss.
17. Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Park and Eberle, and further in view of Leo U.S. 8,622,935 (herein referred to as “Leo ‘935”).
18. Regarding Claim 24, Park fails to teach the multi-core fiber further comprises a center core configured to sense temperature changes by way of the plurality of cores configured to provide optical conduits for respective sensing sensors.
Leo ‘935 teaches a tip assembly of analogous art (Fig. 7), wherein the tip assembly comprises a multi-core fiber (Figs. 7A and 7B, ref nums 152). The multi-core fiber further comprises a center core configured to sense temperature changes (Fig. 7A, ref num 52; Col. 6, lines 62-67 – Col. 7, lines 1-9). By sensing the temperature changes, this aids in compensating for the thermal expansion/contraction of the multi-core fiber (Col. 8, lines 31-45). 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 Park to include a center core configured to sense temperature changes in order to compensate for the expansion/contraction of the multi-core fiber.
19. Claims 25, 28, 36, 37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Park and Eberle, and further in view of Kim U.S. 2014/0276759 (herein referred to as “Kim”).
20. Regarding Claim 25, Park fails to teach the cap of a flex tip comprises a plurality of irrigation through holes.
Kim teaches a tip assembly of analogous art (Fig. 1, ref num 100), in which the tip assembly comprises a cap (Fig. 1, ref num 125). The cap comprises a plurality of irrigation through holes (Fig. 1, ref nums 135; para 0050). This diversion of fluid through the catheter allows for uniformity in cooling the device (para 0047). 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 Park to include irrigation through holes in the cap of the tip in order to properly divert the cooling fluid through the device for uniform cooling.
21. Regarding Claim 28, Park fails to teach the coupler comprises at least one electrical channel.
Kim teaches a tip assembly (Fig. 5, ref num 200) that comprises a coupler (Fig. 6A, ref num 280), a central channel (ref num 282), and an electrical channel (Fig. 5, ref num 287). The electrical channel provides an opening for any electrical components in order to collect further data from the tip assembly (para 0058). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Park to include an electrical channel, as this provides access for electrical components in order to collect the pertinent data of the tip assembly.
22. Regarding Claim 36, Park teaches a coupler (Fig. 6B and 6D, ref nums 616 and 650). However, Park fails to teach a fluid cap couples to a proximal end of the coupler.
Kim teaches a tip assembly (Fig. 5, ref num 200) that also contains a coupler (Fig. 6A, ref num 280), as well as a fluid cap on proximal end of coupler (Fig. 6A, ref num 281). The fluid cap comprises a central channel (Fig. 7A, ref num 282), wherein a structure is disposed through the central channel (Fig. 7A, ref num 282 contains a lumen within it, para 0058). The fluid cap facilitates the flow of the cooling fluid through the designated openings (para 0058). Since Park already teaches that the multi-core fiber is disposed through a central opening in the tip assembly (see Park, Fig. 6C), then it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Park to include a fluid cap coupled to the coupler in order to properly facilitate the flow of cooling fluid through the tip assembly.
23. Regarding Claim 37, Park teaches a coupler (Fig. 6B and 6D, ref nums 616 and 650). However, Park fails an irrigation lumen coupled to the fluid cap.
Kim teaches a tip assembly (Fig. 5, ref num 200) that also contains a coupler (Fig. 6A, ref num 280), as well as a fluid cap on proximal end of coupler (Fig. 6A, ref num 281). The tip assembly further comprises an irrigation lumen coupled to the fluid cap (Fig. 6A, ref num 281 is coupled with ref num 282). The fluid cap and irrigation lumen both facilitate the flow of the cooling fluid through the designated openings (para 0058). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Park to include a fluid cap, as well as the irrigation lumen, in order to properly facilitate the flow of cooling fluid through the tip assembly.
24. Regarding Claim 39, Park teaches a coupler (Fig. 6B and 6D, ref nums 616 and 650). However, Park fails to teach a fluid cap comprising a central channel and at least one electrical channel, wherein the fluid cap is coupled to a proximal end of the coupler; and an irrigation lumen coupled to the fluid cap.
Kim teaches a tip assembly (Fig. 5, ref num 200) that also contains a coupler (Fig. 6A, ref num 280), as well as a fluid cap on proximal end of coupler (Fig. 6A, ref num 281). The tip assembly further comprises a central channel (ref num 282, which as an irrigation lumen through it), an electrical channel (Fig. 5, ref num 287), and an irrigation lumen coupled to the fluid cap (Fig. 6A, ref num 281 is coupled with ref num 282). The fluid cap and irrigation lumen both facilitate the flow of the cooling fluid through the designated openings (para 0058). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Park to include a fluid cap, as well as the irrigation lumen, in order to properly facilitate the flow of cooling fluid through the tip assembly.
25. Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Park and Eberle, and further in view of Govari U.S. 2017/0209209 (herein referred to as “Govari”).
26. Regarding Claim 32, Park teaches the support tube slot (Fig. 6B, ref num 614), but Park fails to explicitly teach the support tube slot comprises a helical slot in the support tube.
Govari teaches a probe (Fig. 1, ref num 20) which contains a distal end (Fig. 2A, ref num 22). The distal end provides a support tube (see Fig. 2D, a support tube fits into the insertion tube, ref num 70), which comprises a helical slot in the support tube (Fig. 2D, ref num 96, para 0087 “comprise a plurality of helices 96”). The helical slot aids in the detection of the force that is applied the distal end, such that the movement causes a change in the signals for the system (para 0089). 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 Park and included that the support tube slot have a helical slot in order to aid in force detection and movement of the device.
27. Regarding Claim 33, Park as modified by Govari teaches the helical slot spans a full length of the fiber support tube (Park, Fig. 6B, ref num 614 spans the length of the fiber support tube).
28. Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Park and Eberle, and further in view of Larkin U.S. 2007/0151391 (herein referred to as “Larkin”).
29. Regarding Claim 34, Park fails to teach the support tube slot is filled with flexible material.
Larkin teaches a tip assembly of analogous art (Fig. 3A, 4A, and 4B), wherein the assembly comprises a fiber support tube (Fig. 4A and 4B, ref num 218). The fiber support tube comprises a slot filled with flexible material (Fig. 4B, ref num 215; para 0047, “narrow annular gap…is filled with an elastomeric material 215”). The flexible material prevents high and varying axial forces from being transmitted throughout the tip assembly (para 0047). 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 Park to have the support tube slot filled with a flexible material as this distributes the axial forces evenly throughout the tip assembly.
30. Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Park, Eberle, and Larkin, and further in view of Hindricks U.S. 2004/0181138 (herein referred to as “Hindricks”).
31. Regarding Claim 35, Park fails to teach the flexible material creates a watertight seal.
Hindricks teaches a tip assembly of analogous art, wherein the tip comprises a water-tight seal (para 0043). The water-tight seal prevents fluid from leaking out of the tip (para 0043). 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 Park to have the flexible material create a watertight seal in order to prevent fluid from leaking out of the tip.
32. Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Park, Eberle, and Kim, and further in view of Nguyen U.S. 2010/0041986 (herein referred to as “Nguyen”).
33. Regarding Claim 40, Park as modified fails to teach a portion of the multi-core fiber is disposed within the irrigation lumen.
Nguyen teaches a catheter (ref num 110), in which at the distal tip the fluid lumen (Fig. 4A, ref num 404) has a multi-core fiber residing within it (Fig. 4A, ref num 604i). By having the multi-core fiber residing within the irrigation lumen, this provides a cooling fluid to prevent overheating of the tissue and/or the ablation electrodes (para 0005). 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 Park-Kim and included the multi-core fiber being disposed within the irrigation lumen to prevent overheating, as it produces the same expected result.
Conclusion
34. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794