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 .
The current application has the effective filing date of 08/11/2021 according to the priority chain on the record.
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 10-12 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.
Regarding claim 10, the limitation “terminating one or more tendons in a cap” is vague and indefinite, it is unclear whether in this clause ‘terminating’ refers to actively ending/cutting the tendons, or indicating an end point of the tendons’ length. Furthermore, the term ‘terminating’ is a relative term, there should be a starting point or action to give context to said “terminating.”
Claims 11 and 12 are rejected as indefinite as they depend from a rejected claim.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. WO 2019/133439 A1 (hereinafter “Kim”, provided by the Applicant).
Regarding claim 1, Kim discloses a robotic catheter system (see Figs. 15-20) comprising:
a handle (controllable drive mechanism 250) comprising one or more actuators (motor 260), and
a housing cap (adaptor coupling 252) releasably connectable with the handle (250), the housing cap having one or more tendons connected to a catheter (surgical instrument 220; releasable connection between 250 and 252 are described in [0052, 0064-0066] and shown in Figs. 16 and 20),
wherein the handle (250) and housing cap (252) are configured so that when the housing cap connects with the handle (releasable coupling by rotating connections 402 and 404 as shown in Fig.20), the one or more tendons (wires 297, 298) engage with the one or more actuators (motor 260 ; also see [0050] “ As will be described herein, the adaptor coupling 252 is releasably connectable to the controllable drive mechanism 250 by being locating on a boss 251 extending therefrom, and includes therein a plurality of wire actuation members which are selectively moveable with respect to the adaptor coupling 252 under the control of the controllable drive mechanism 250. ”).
Regarding claim 2, Kim discloses the robotic catheter system of claim 1 wherein the one or more actuators (motor 260) comprise one or more linear actuators. ([0063] “linear actuator”)
Regarding claim 3, Kim discloses the robotic catheter system of claim 1 wherein the one or more tendons (wires 297, 298) terminate at respective one or more anchors (second connector portion 274), wherein the one or more anchors are releasably connectable to shafts (threaded shaft 262 and extension member 272) of the one or more actuators (260), respectively. (See [0052] and Fig. 17; also see [0061] and Fig. 19)
Regarding claim 4, Kim discloses the robotic catheter system of claim 3 wherein the anchors (274) or ends of shafts (262, 272) comprise magnets such that the anchors (274) are releasably connectable to the ends of the shafts via magnetism. ([0053] magnetic coupling)
Regarding claim 5, Kim robotic catheter system of claim 1 wherein the housing cap comprises one or more extensions configured to connect to the handle with a twist motion. (As shown in Fig. 20: coupling by rotating in directions 402, 404, also see [0064, 0066])
Regarding claim 10, Kim discloses a method for separating a catheter from a robotic component (Figs. 15-20), the method comprising:
housing one or more actuators (motor 260) in a handle (controllable drive mechanism 250);
terminating one or more tendons (wires 297, 298) in a cap (adaptor coupling 252) (“terminating” is rejected under 35 USC 112(b) indefiniteness, it is the Examiner’s best guess that the recited “tendons” has one end in the cap, this is taught in [0052: 2nd sentence] “wire ends 46, 48 of the wire 297 coupled to the end effector 100 described previously herein inwardly and outwardly of the proximal end 221 of the flexible tubular member 222, each of the wire ends 298a, b, including wire ends 46, 48, are individually coupled to a lead screw mechanism 254 dedicated thereto and located in a housing 256” ); and
releasably connecting the cap to the handle (releasable connection between 250 and 252 are described in [0052, 0064-0066] and shown in Figs. 16 and 20);
wherein releasably connecting the cap to the handle connects one or more shafts (threaded shaft 262 and extension member 272) of the one or more actuators (260) to the one or more tendons (wires 297, 298), respectively. (See [0052] and Fig. 17; also see [0061] and Fig. 19)
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Haubert US 2022/0040450 A1 (provided by the Applicant).
Regarding claim 1, Haubert discloses a robotic catheter system (see Figs.1-3 robot-assisted steerable medical device) comprising:
a handle (actuator system 300; see Figs. 1A-1B) comprising one or more actuators (actuators 311), and
a housing cap (steerable instrument 100) releasably connectable with the handle (300) (releasable connection is taught via magnetic connection hub 500; see [0009-0010, 00056-0059] and see Figs. 1-4), the housing cap (100) having one or more tendons (drive wires 110) connected to a catheter (see Figs. 1A-1B; wires 110 is part of a catheter 100),
wherein the handle (300) and housing cap (100) are configured so that when the housing cap connects with the handle, the one or more tendons (110) engage with the one or more actuators (actuators 311; releasable connection between 110 and 300 is taught via magnetic connection hub 500, said hub includes engaging tendons with actuators as shown in Fig. 2; also see [0009-0010, 00056-0059]).
Regarding claim 2, Haubert discloses the robotic catheter system of claim 1 wherein the one or more actuators (actuators 311) comprise one or more linear actuators. ([0045] actuator can be linear inductive motor)
Regarding claim 3, Haubert discloses the robotic catheter system of claim 1 wherein the one or more tendons (110) terminate at respective one or more anchors (magnetic connectors 510; see Figs. 1B and 2), wherein the one or more anchors (510) are releasably connectable to shafts (catheter-side shaft 512) of the one or more actuators (311), respectively. (releasable connection is taught via magnetic connection hub 500; see [0009-0010, 00056-0059] and see Figs. 1-4)
Regarding claim 4, Haubert discloses the robotic catheter system of claim 3 wherein the anchors (510) or ends of shafts (catheter-side shaft 512, and actuator-side shaft 517) comprise magnets (magnets 515, 615) such that the anchors (510) are releasably connectable to the ends of the shafts (512, 517) via magnetism. (see Figs. 7A-9B, and also see [0061-0081] which discussed magnetic coupling and breakaway forces)
Regarding claim 5, Haubert robotic catheter system of claim 1 wherein the housing cap (100) comprises one or more extensions (catheter-side steel catch 513) configured to connect to the handle with a twist motion. (See Figs. 10B-10E connection via magnetic coupling through twisting direction 520 by aligning 513 with 515; also see [0086-0088])
Regarding claim 6, Haubert discloses the robotic catheter system of claim 5 wherein the housing cap comprises a spring (lock 503, e.g. mechanical loaded beam/knob: [0057: last sentence]) configured to be compressed for connection of the housing cap with the handle ([0057] lock 503 as part of the magnetic connection hub 500), the extensions including hooks (guiding pin 502) to engage the handle where the spring disposes (opening 505) the hooks to stay in place when connected ([0057: last sentence] to prevent accidental disengagement).
Regarding claim 7, Haubert discloses the robotic catheter system of claim 1 wherein the housing cap (100) comprises a releasable clamp (second magnet 515 or alternatively 615 in Fig. 6) configured to hold the one or more tendons (wire 411 coupled to magnetic connector 510 and catheter-side shaft 512) when the housing cap (100) is not connected to the handle (300). (Figs. 8A-9B; see [0082-0083])
Regarding claim 8, Haubert discloses the robotic catheter system of claim 7 wherein the one or more tendons (110) terminate at one or more anchors (magnetic connector 510; see Figs. 1B and 2), respectively, and wherein the releasable clamp (515) is configured to hold the one or more anchors (510) until the housing cap connects to the handle. (Figs. 8A-9B; see [0082-0083])
Regarding claim 9, Haubert discloses the robotic catheter system of claim 7 wherein the releasable clamp comprises a fan lock (Fig. 10B-10C which illustrates the rotating two parts to form a lock, also see annotated Fig. 10B and claim 18 rationale below) connected to a slider (guiding pin 205 which slides along the key way 501) exposed on an exterior of the housing cap (Figs. 10B: 501, 502), the fan lock configured to release the one or more tendons in response to movement of the slider relative to the housing cap. ([0089] sliding the guiding pin 502 along keyway 501 would release the connection hub 500)
Regarding claim 10, Haubert discloses a method for separating a catheter (instrument 100) from a robotic component (actuator system 300), the method comprising:
housing one or more actuators (actuators 311) in a handle (actuator system 300; see Figs. 1A-1B);
terminating one or more tendons (drive wires 110) in a cap (steerable instrument 100) (“terminating” is rejected under 35 USC 112(b) indefiniteness, it is the Examiner’s best guess that the recited “tendons” has one end in the cap. This is taught in Haubert Fig. 1B which illustrates that wires 110 terminates at a magnetic connectors 510 within the cap, i.e. 100; also see [0009, 0053]); and
releasably connecting the cap (100) to the handle (300) (releasable connection is taught via magnetic connection hub 500; see [0009-0010, 00056-0059] and see Figs. 1-4);
wherein releasably connecting the cap (100) to the handle (300) connects one or more shafts (catheter-side shaft 512, and actuator-side shaft 517) of the one or more actuators (311) to the one or more tendons (110), respectively. (see [0062] and see Figs. 2 and 4 regarding wires 110 to shafts 512 to 51)
Regarding claim 11, Haubert teaches the method of claim 10 wherein releasably connecting comprises pressing the cap to the handle and against a spring force (compressive/tensile force illustrated in Figs. 7A-7B, also see [0079-0080]) and twisting the cap relative to the handle, the twisting engaging the cap to the handle. (See Fig.4: twisting motion/direction 520 to lock/unlock magnetic hub connection 500, also see [0084, 0086])
Regarding claim 12, Haubert teaches the method of claim 10 further comprising clamping terminal ends (magnetic connectors 510) of the one or more tendons (44) in the cap (100) and releasing the clamping after the cap is releasably connected to the handle. (see Figs. 9A-9B and [0083] “…a plurality of ring-shaped magnets which can allow for mechanical constraint through clamping as opposed to adhesives”)
Regarding claim 13, Haubert discloses a catheter system (see Figs.1-3 robot-assisted steerable medical device) comprising:
a housing (actuator system 300 with housing 504) connected with a catheter (steerable instrument 100; see magnetic connection hub 500 in [0009-0010, 00056-0059] and Figs. 1-4);
one or more tendons (drive wires 110) of the catheter (100) extending into the housing (see Fig.1, wires 110 extending into actuator 300 with housing 504 via magnetic connection hub 500);
a releasable clamp (second magnet 515 or alternatively 615 in Fig. 6) in the housing (300, 504), the releasable clamp configured to clamp the one or more tendons (110 coupled with shaft 517). (Figs. 8A-9B; see [0082-0083])
Regarding claim 14, Haubert discloses the catheter system of claim 13 wherein the one or more tendons (110) terminate at one or more anchors (magnetic connector 510; see Figs. 1B and 2), respectively, and wherein the releasable clamp (515 or alternatively 615 in Fig. 6) is configured to clamp the one or more anchors (510; Figs. 8A-9B; see [0082-0083]).
Regarding claim 15, Haubert discloses the catheter system of claim 14 wherein the one or more anchors comprise one or more bushings (magnetic enclosure 614), respectively, and wherein the releasable clamp (515/615) is configured to clamp around a part of each of the one or more bushings ([0075-0076]).
Regarding claim 16, Haubert the catheter system of claim 13 wherein the releasable clamp (515/615) is configured to clamp all of the one or more tendons (Under BRI, claim 13 recites “one or more tendons”, therefore in claim 16, “all of one or more tendons” requires clamping down one tendon, which is taught in Figs. 7A-9B; see [0082-0083] 515 or 615 clamps down corresponding tendons).
Regarding claim 17, Haubert discloses the catheter system of claim 13 wherein the releasable clamp comprises a fan lock. (Figs. 10B-10C and [0085-0087]; also see rejection to claim 18 below)
Regarding claim 18, Haubert discloses the catheter system of claim 17 wherein the fan lock comprises two plates, at least one of the plates rotatable in relative to another of the plates where rotation in a first direction (two way arrow 520 indicates rotation) clamps terminal ends of the one or more tendons and where rotation in a second direction (two way arrow 520) releases the terminal ends. (See Figs. 10C alignment between 513 and 515 based on rotating “plates” with respect to one another; see annotation Fig. 10B below)
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Regarding claim 19, Haubert discloses the catheter system of claim 13 further comprising a slider on an exterior of the housing, the slider (sliding plunger 612) connected to the releasable clamp (614) to release the one or more tendons. (see Fig. 6)
Regarding claim 20, Haubert discloses the catheter system of claim 13 further comprising a handle (handle 200) releasably connectable with the housing (300, 504) where the handle being connected with the housing also connects shafts (actuator-side shaft 517) of actuators (311) in the handle with the one or more tendons (wire 110), wherein the releasably clamp is configured to clamp until the one or more tendons are connected to the shafts. (Figs. 8A-9B; see [0082-0083])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
January 9, 2026