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 with respect to amended claim(s) 1-3, 21 and new claim 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
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.
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 following rejection has been modified in view of applicant's arguments and/or amendments.
Claims 1-3 and 5-15 are rejected under 35 U.S.C. 103 as being unpatentable over “Belson,” US 2007/0135803 (hereinafter Belson) and “Chou et al.,” US 2021/0330332 (hereinafter Chou).
Regarding to claim 1, Belson teaches a system comprising a sensing instrument, including:
an elongate flexible member including a channel extending therein for receiving an interventional tool (flexible backbone with lumen for working channel [0236]),
the elongate flexible member including a proximal portion, a distal portion, and a flexure portion between the distal and proximal portions (distal portion 24, an automatically controlled portion 28 and a proximal portion 22 Figure 25 [0239]);
a flexure at the flexure portion of the elongate flexible member (automatically controlled portion is segmented, each segment is capable of bending through a full range of steerable motion [0239]);
a sensing element coupled at the distal portion of the elongate flexible member (endoscope, fiber optic imaging bundle extend to the distal end, video endoscope with CCD camera positioned at the distal end [0219]);
a flexure control apparatus extending within the elongate flexible member and configured to bend the flexure to change an orientation of the sensing element relative to the proximal portion of the elongate flexible member (automatically controlled portion is segmented, each segment is capable of bending through a full range of steerable motion [0239]);
an exit port in the proximal portion of the elongate flexible member, the exit port extending between the channel and an outer surface of the elongate flexible member ( access port used as a tool access port [0682])
Belson does not explicitly disclose that the exit port in the proximal portion of the member for providing the interventional tool outside of the channel, the exit port extending between the channel and an outer surface of the elongate flexible member and an entry port for receiving the interventional tool into the channel, the entry port being proximal to the exit port.
However, in the analogous field of endeavor in navigating a flexible elongate medical instrument within the patient’s body, Chou teaches an interventional device for medical procedure wherein the exit port in the proximal portion of the member for providing the interventional tool outside of the channel (mouth located proximal to the distal end 508 Fig. 1A, Figure 12B [0159]), the exit port extending between the channel and an outer surface of the elongate flexible member (mouth 508 allows for a working device to exit at a range of angles Fig. 12B [0159]) and an entry port for receiving the interventional tool into the channel, the entry port being proximal to the exit port (414 and 416 proximal port, working lumen 410 can extend from a distal end to a working proximal port 416 of the proximal portion of the elongated body Fig. 11 [0155]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify access port as taught by Benson to incorporate teaching of Chou, since exit port located proximal portion of the member and entry port being proximal to the exit port was well known in the art as taught by Chou. One of ordinary skill in the art could have combined the elements as claimed by Benson with no change in their respective functions, configuring access port to be located on the proximal to the distal portion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to allow working device to exit at a range of angles and arrangement for ease of delivery of a working device even in the presence of a severe angulation within the vessel and bifurcation ([0159]), and there was reasonable expectation of success.
Regarding to claim 2, Belson in view of Chou together teach all limitations of claim 1 as discussed above.
Chou further teaches the interventional tool is configured to extend through the channel and exit the elongate flexible member through the exit port as the interventional tool is moved in a distal direction ([0159]).
Regarding to claims 3 and 5-15, Belson in view of Chou together teach all limitations of claim 1 as discussed above.
Belson further teaches following limitations:
Of claim 3, wherein the interventional tool includes a biopsy needle, an ablation tool, or an electroporation tool (ablation probe [0387])
Of claim 5, wherein the interventional tool is configured to deliver a device into a patient anatomy ( steerable instrument manipulated the delivery of the device within the body [0792])
Of claim 6, wherein the sensing element includes an imaging element (imaging bundle, endoscope [0219])
Of claim 7, wherein the imaging element includes an ultrasound transducer (ultrasound transducers [0651]; ultrasound sensor on the distal end of the tube [0752]).
Of claim 8, wherein the imaging element includes a visible light camera (camera [0219] and blue light, visible range light [0408]).
Of claim 9, wherein the sensing element includes an infrared sensor (IR fiberoptic spectroscopy device [0404])
Of claim 10, wherein the flexure includes a shape memory tube, and elastomeric tube, or a polymer tube (shape memory alloy [0242])
Of claim 11, wherein the flexure includes a plurality of slits, a plurality of links, or a hinge (tendons, hinges [0264])
Of claim 12, wherein the flexure control apparatus includes a push-pull wire (tendon is a push-pull cable [0257])
Of claim 13, wherein the flexure control apparatus includes a plurality of tendons (tendons [0242])
Of claim 14, wherein the flexure control apparatus is configured to be moved by a robot-assisted manipulator (robotic endoscope [0288]; a robotic handler [0359]).
Of claim 15, wherein the flexure control apparatus is configured for manual control (manually steering [0271]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Belson and Chou as applied to claim 1 above, and further in view of “Wong et al.,” WO 2021/207264 (hereinafter Wong)
Regarding to claim 16-17, Belson in view of Chou together teach all limitations of claim 1 as discussed above.
Belson and Minas do not further explicitly teach optical fiber shape sensor.
However, in the analogous field of endeavor in medical instrument manipulation, Wong teaches following limitations:
Of claim 16, wherein the sensing instrument further includes a deflection sensor (optical fiber shape sensor, strain measurement [0159])
Of claim 17, wherein the deflection sensor includes an optical fiber shape sensor (optical fiber shape sensor [0159])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify flexible elongate member as taught by Belson to incorporate teaching of Wong, since shape sensor including an optical fiber was well known in the art as taught by Wong. One of ordinary skill in the art could have combined the elements as claimed by Belson with no change in their respective functions, the elongate flexible member to include an optical fiber shape sensor, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to track and determine the shape of the flexible elongate member ([0159]), and there was reasonable expectation of success.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Belson and Chou as applied to claim 1 above, and further in view of “Alvarez et al.,” US 2010/0280449 (hereinafter Alvarez).
Regarding to claims 18-20, Belson and Chou together teach all limitations of claim 1 as discussed above.
Belson further teaches a delivery catheter including a channel configured to receive sensing instrument (flexible backbone with lumen for working channel [0236]), and a selectively steerable instrument has a controllable distal end and proximal portion is configured as a flexible tube ([0199]) and a delivery catheter (Guide catheter [0288]) wherein the sensing element is coupled to a distal end of the delivery catheter portion (catheter with distal end of the shaft with instrument [0726]).
Belson further teaches multi-segmented endoscope device, steerable segmented endoscopes wherein each segment may be individually actuated or controlled to create arbitrary shapes ([0290] and [0306], [0319]).
The examiner further submits “Alvarez” which teaches flexible and elongate instruments with shape control elements, such as catheter ([0056]), wherein distal, middle and proximal portion of the elongate instrument is manipulated and inserted wherein each portion can be manipulated independently from other portion ([0090]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify instrument as taught by Belson to incorporate teaching of Alvarez, as both Belson and Alvarez are directed to selectively steerable instruments, and since independent manipulation of parts was well known in the art as taught by Alvarez. One of ordinary skill in the art could have combined the elements as claimed by Belson with no change in their respective functions, its flexible elongate member to be segmented with independent manipulation, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to advance instrument through a pathway inside the patient, manipulating its mid portion to conformed shape or curvature in the pathway, while distal portion of instrument is manipulated to assume a curvature independent of the mid portion ([0021]) and there was reasonable expectation of success.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over “Wong et al.,” WO 2021/207264 (hereinafter Wong) and “Belson,” US 2007/0135803 (hereinafter Belson), and “Chou et al.,” US 2021/0330332 (hereinafter Chou).
Regarding to claim 21, Wong teaches a method comprising:
positioning a sensing instrument in an anatomic passageway proximate to an anatomic target tissue (flexible instrument navigate tortuous anatomical passageways and facilitate delivery of flexible instrument to a target site within patient anatomy [0117])
the sensing instrument including an elongate flexible member, a flexure, a sensing element coupled at a distal portion of the elongate flexible member (medical instrument house cables, linkages or actuation controls that extend between proximal and distal ends to controllably bend distal end of the medical instruments [0161], medical instrument include an imaging system, imaging instrument component integrally or removably coupled to the medical instrument [0155]),
a flexure control apparatus extending within the elongate flexible member (cables, linkages or actuation controls that extend between proximal and distal ends to controllably bend distal end of the medical instruments [0161]), and an exit port in a proximal portion of the elongate flexible member (instrument port [0160]);
bending the sensing instrument at the flexure with the flexure control apparatus to move the sensing element toward the anatomic target tissue (cables, linkages or actuation controls that extend between proximal and distal ends to controllably bend distal end of the medical instruments [0161]; medical instrument include image capture probes [0160]); and
deploying an interventional tool through the elongate flexible member and through the exit port (medical instrument can be removed via access port, medical instrument may be used with an imaging instrument [0160]).
However, in the analogous field of endeavor in flexible instrument navigation, Belson discloses a sensing element coupled at a distal portion of the elongate flexible member, since Belson teaches endoscope has an elongate body with selectively steerable distal portion and an automatically controlled proximal portion, wherein camera is positioned at the distal end of the endoscope body ([0219] Fig. 7) and deploying an interventional tool through the elongate flexible member under guidance from the sensing element (image guidance allow the user to indicate a new desired path to input to control system to articulate or manipulate the steerable, controllable instrument [0632]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify imaging element as taught by Wong to incorporate teaching of Belson, since image guidance of steerable instrument was well known in the art as taught by Belson. One of ordinary skill in the art could have combined the elements as claimed by Wong with no change in their respective functions, using imaging element to be coupled to the distal end and using the imaging to navigate the elongate flexible body, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to allow user to articulate or manipulate the steerable instrument based on the image guidance ([0632]), and there was reasonable expectation of success.
Wong and Belson do not explicitly disclose that the exit port in the proximal portion of the member for providing the interventional tool outside of the channel, the exit port extending between the channel and an outer surface of the elongate flexible member and an entry port for receiving the interventional tool into the channel, the entry port being proximal to the exit port.
However, in the analogous field of endeavor in navigating a flexible elongate medical instrument within the patient’s body, Chou teaches an interventional device for medical procedure wherein the exit port in the proximal portion of the member for providing the interventional tool outside of the channel (mouth located proximal to the distal end 508 Fig. 1A, Figure 12B [0159]), the exit port extending between the channel and an outer surface of the elongate flexible member (mouth 508 allows for a working device to exit at a range of angles Fig. 12B [0159]) and an entry port for receiving the interventional tool into the channel, the entry port being proximal to the exit port (414 and 416 proximal port, working lumen 410 can extend from a distal end to a working proximal port 416 of the proximal portion of the elongated body Fig. 11 [0155]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify access port as taught by Benson to incorporate teaching of Chou, since exit port located proximal portion of the member and entry port being proximal to the exit port was well known in the art as taught by Chou. One of ordinary skill in the art could have combined the elements as claimed by Benson with no change in their respective functions, configuring access port to be located on the proximal to the distal portion, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to allow working device to exit at a range of angles and arrangement for ease of delivery of a working device even in the presence of a severe angulation within the vessel and bifurcation ([0159]), and there was reasonable expectation of success.
Regarding to claims 22-23, Wong, Belson, and Chou together teach all limitations of claim 21 as discussed above.
Belson further teaches following limitations:
Of claim 22, rotating the sensing element to position the sensing element toward the anatomic target tissue (the fiberoptic spectroscopy device rotates to scan the tissues as the steerable colonoscope advances or retreats [0404]).
Of claim 23, receiving the guidance from the sensing element, wherein the guidance from the sensing element includes ultrasound image data from the sensing element (intraoperative scans, IVUS images [0593]) and adjusting the sensing instrument based on the guidance (image guidance allow the user to indicate a new desired path to input to control system to articulate or manipulate the steerable, controllable instrument [0632]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Belson and Chou as applied to claim 1 above, and further in view of “Barrish et al.,” US 2020/0188635 (hereinafter Barrish).
Regarding to claim 24, Belson and Chou together teach all limitations of claim 1 as discussed above.
Wong, Benson, and Chou do not further teach wherein the proximal portion of the elongate flexible member includes an articulation region, and wherein the articulation region is configured to articulate independently of being the flexure.
However, in the analogous field of endeavor in flexible elongate member and its articulation, Barrish teaches an elongate flexible member comprising multiple segments and independent articulation of each segment ([0103] and [0139]-[0140]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify flexible elongate member and its articulation as taught by Benson to incorporate teaching of Barrish, since independent articulation of plurality of segments was well known in the art as taught by Barrish One of ordinary skill in the art could have combined the elements as claimed by Benson with no change in their respective functions, configuring its elongate flexible member to comprise multiple segments with each corresponding articulation, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide enhanced articulation of the tool to achieve a desired alignment with a target tissue ([0010]), and there was reasonable expectation of success.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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