CTNF 18/781,444 CTNF 82792 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kaiser (US 20210259790), cited in IDS . Regarding claim 1, Kaiser discloses a steerable medical instrument 100 (Fig. 2A-B, abstract, A steerable medical instrument, such as a catheter or endoscope, comprises a tubular body having non-steerable section and steerable sections arranged from a proximal end to a distal end thereof), comprising: a catheter body (section 0009, a robotically steerable medical instrument, such as an endoscope or a catheter, comprising an elongate tubular body having a longitudinal axis, a proximal end, a distal end, and a plurality of channels arranged along the wall of the tubular body) having a proximal section 102 (section 0044, The steerable instrument 100 has a generally tubular shape with a proximal non-steerable section 102) configured to be mechanically coupled to an actuator 200 (Fig. 1A, section 0048, The handle 200 includes mechanical, electronic, electrical, and optical components which serve to provide electromechanical interconnection between the steerable instrument), and a distal section 103 configured to be actuated by the actuator 310 (Fig. 1B, Section 0044, The distal steerable section 103 includes a plurality of bending segments (1, 2, 3 . . . N); and at least one of these bending segments can be mechanically actuated by one or more control wires to bend the steerable instrument), the catheter body having a tool channel 105 which extends along a central axis from a proximal end of the catheter body to a distal end of the catheter body (Section 0050, Along the shaft's length, there are one or more working channels 105 extending along (typically inside) the tubular shaft, and a plurality of wire conduits 104 extending along (typically within) the wall of the tubular shaft), the catheter body having at least one control wire 110 (Fig. 1B, section 0053, The wire conduits 104 allow anchorage and/or passage of control wires 110 used for steering (bending or twisting) at least one segment or section of the shaft) and at least one electrical cable 112 arranged lengthwise along a wall of the catheter body (Fig. 1B, section 0053, at least some wire conduits 104 can be used to pass one or more electrical cables 112. Electrical cables 112 are configured to establish an electrical connection between an electronic device arranged at the distal end or within the steerable section 103 and a terminal (212 or 213) or a signal processing circuit located outside of the proximal end of the instrument), the catheter body further comprising a distal tip 120 configured at the distal end of the distal section of the catheter body (Fig. 4A. 4B2, section 0073, The steerable section includes an atraumatic distal tip 120 which includes one or more sensors (EM sensor 190)), the distal tip configured to house at least a portion of an electrical component 180, 190, wherein the distal section includes a plurality of wire-guiding members 108, 408 arranged at a predetermined distance from each other so as to form a plurality of void regions alternately interposed with the plurality of wire-guiding members in the lengthwise direction of the catheter body (Section 0057, The control wires 110 are initially passed through wire conduits 104 formed along (within) the wall of non-steerable section 102, and then routed through holes in the plurality of wire-guide members 108 and wire-anchor members), and a distal guide ring 109b configured at the distal end of the distal section for attaching the at least one control wire (Figs. 2A-B, section 0056, 0057, wire-anchor member 109a has control wires anchored to it and control wires passing through it non-anchored. A wire-anchor member 109b has control wires anchored to it, and it may also have support wires and/or an EM sensor attached to it. The anchor members 109a, 109b and guide members 108a, 108b have an annular shape (disk or ring shape)), wherein the at least one control wire 110 allows the distal guide ring 109 to be in communication with the actuator 310 and at least one control wire 110 is configured to transfer an actuating force from the actuator to the distal guide ring of the catheter body so as to bend at least a portion of the distal section (Section 0059, 0061, the non-steerable section 102 has a function of transmitting an actuating force from the actuator system 310 to the bending segments of the steerable section 103 substantially without slack, control wire 110b may be fixed or anchored to anchor member 109, control wire 110a is pulled with a first control force F.sub.1, and control wired 110c is pulled with a second control force F.sub.2 different from force F.sub.1 (control force F.sub.2 is smaller than control force F.sub.1, in this example). In this manner, the bending segment 103 can be actuated and bent in a desirable direction (direction of force F.sub.1), in accordance with a combination of the driving amounts (strain) or linear displacements of control wires 110a and 110c), wherein the electrical cable 112 is configured to establish an electrical connection between an electrical circuit located outside the catheter body (section 0100, electrical cable 112 is configured to establish an electrical connection between an EM sensor 190 located in the distal tip 120 and an electrical circuit (not shown) located outside (at the proximal end) of the steerable instrument) and the electronic component 180, 190 arranged within the distal tip 120 (Fig. 4A-B2, section 0100, electrical cable 112 is configured to establish an electrical connection between an EM sensor 190 located in the distal tip) and wherein the electrical component 190 bridges the distal tip 120 and distal guide ring 408 (Fig. 8B, section 0100, the electrical cable 112 undergoes a gradual transition or a bend along a curved path 812 formed in a wire-guiding member 408 before the cable begins to be coiled in the void region). Regarding claim 2, Kaiser discloses the electrical component 180, 190 is selected from the groups consisting of an endoscope camera, a position sensor, an orientation sensor, or combinations thereof (Section 0120, electrical cables 112 can be connected to an EM sensor 190 and/or to an imaging device (camera) 180). Regarding claim 3, Kaiser discloses the distal tip 120 comprises a cap to protect the distal tip (Figs. 4A, B2, 8B examiner’s broadest reasonable interpretation finds that the tip 120 of Kaiser is protective to hold the sensor 190). Regarding claim 4, Kaiser discloses the distal tip comprises a first notch 812 for housing at least a portion of the electrical component (Fig. 8b, section 0100, the electrical cable 112 undergoes a gradual transition or a bend along a curved path 812 formed in a wire-guiding member 408 before the cable begins to be coiled in the void region). Regarding claim 5, Kaiser discloses each of the wire-guiding members 108, 408 comprises a second notch 512 for passage of the electrical cable through the distal section (Fig. 6A-B, section 0098, the cable 112 is guided through a slot or groove 512 (see FIG. 6A and FIG. 6B) formed on the wall of each wire-guiding member 408). Regarding claim 6, Kaiser discloses the electrical cable includes strain relief elements arranged in one or more void region such that when the electrical cable is subjected to a tensile load by the actuating force bending the distal section of the catheter body, the strain relief elements within the one or more void regions eliminates the tensile load on the electrical cable. Regarding claim 7, Kaiser discloses the strain relief elements include first portions of the electrical cable112 which are loosely arranged within the one or more void regions 409 such that, within the one or more void regions, the first portions of the electrical cable can freely move, slide, and/or tighten in response to the actuating force bending the distal section to thereby provide strain relief to, or eliminate the tensile load of, the electrical cable (Section 0094, the electrical cable 112 is loosely arranged in a void region 409 forming a helical loop around the body of the catheter shaft. In this state, the electrical cable 112 has an amount of slack and can freely move or slide within the void region). Regarding claim 8, Kaiser discloses an inner sheath 430 configured to enclose at least part of the tool channel (Section 0075, an inner sheath 430 can be fabricated as a single component to define therein a tool channel), wherein the one or more wire-guiding members 108, 408 and the void regions 409 interposed with the one or more wire-guiding members 108, 408 are arranged around the inner sheath 430, wherein both the electrical cable 112 and the control wires 110 surround the inner sheath (Fig. 4C-D, claim 11, page 21 lines 14-18, the one or more wire-guiding members and the void regions interposed with the one or more wire-guiding members are arranged around the inner sheath, wherein both the electrical cable and the control wires surround the inner sheath), wherein the one or more wire-guiding members are attached to the inner sheath by reflowing material of the wire-guiding members and/or material of the inner sheath onto each other (claim 11, page 21 lines 19-22, the one or more wire-guiding members are attached to the inner sheath by reflowing material of the wire-guiding members and/or material of the inner sheath onto each other). Regarding claim 9, Kaiser discloses an outer sheath 450 806, configured to enclose at least part of the distal section of the catheter body (claim 14, page 21, lines 43-44), wherein the outer sheath 450, 806 encloses the one or more wire-guiding members 108, 408 and the void regions 409 interposed with the one or more wire-guiding members (claim 14, page 21, lines 45-47, the outer sheath encloses the one or more wire-guiding members and the void regions interposed with the one or more wire-guiding members), wherein the outer sheath 450, 806 surrounds both the electrical cable 112 and the control wires 110 within the void regions 409 interposed with the one or more wire-guiding members 108, 408 (claim 14, page 21, lines 48-50), and wherein, when the tensile load by the actuating force bends the distal section of the catheter body, the outer sheath is configured to prevent prolapse of the electrical cable and/or control wires within the void regions interposed with the one or more wire-guiding members (section 0098, Claim 14 page 21 lines 52-56, To prevent prolapse of the control wires 110, in addition to coiling the electrical cable 112 in the void regions 409, the steerable section 103 is enclosed in a flexible and substantially transparent outer sheath. When the tensile load by the actuating force bends the distal section of the catheter body, the outer sheath is configured to prevent prolapse of the electrical cable and/or control wires within the void regions interposed with the one or more wire-guiding members). Regarding claim 10, Kaiser discloses the electrical cable 112 is made of one or more strands of electrically conducing wire (Section 0130, the electrical cable 112 can be comprised of one or more e.g., two conducting elements, including, for example, two electrical conducting wires copper wires for conducting electricity), wherein at least part of the one or more strands of electrical conducting wire are wound into a twisted pair cable (section 0054, electrical cable 112 can be a coaxial cable, a twisted multi-cable bundle) or weaved into a braided multi-strand cable (section 0137, the electrical cable 112 may include one or more electrical wires (strands of wire), and at least part of the cable's wires are wound in a braided like fashion). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST. 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, David Hamaoui can be reached at 571-270-5625. 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. /JON ERIC C MORALES/Primary Examiner, Art Unit 3796 /J.C.M/Primary Examiner, Art Unit 3796 Application/Control Number: 18/781,444 Page 2 Art Unit: 3796 Application/Control Number: 18/781,444 Page 3 Art Unit: 3796 Application/Control Number: 18/781,444 Page 4 Art Unit: 3796 Application/Control Number: 18/781,444 Page 5 Art Unit: 3796 Application/Control Number: 18/781,444 Page 6 Art Unit: 3796 Application/Control Number: 18/781,444 Page 7 Art Unit: 3796 Application/Control Number: 18/781,444 Page 8 Art Unit: 3796
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