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, filed March 2, 2026 with respect to the double patenting rejection and the 102 rejections of claims 1-4, 10, 12, and 16-20 and the 103 rejections of claim(s) 5-9, 11, and 13-15 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection have been made in view of applicant’s amendments as can be further seen below.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0297384 A1 to Bacich et al. (hereinafter “Bacich”).
Regarding claims 1 and 20, Bacich teaches:
A guidable and growable instrument (see abstract and figs. 1A-1C) comprising:
a growable tube comprising an inner layer, an outer layer, and a fluid cavity between the inner layer and the outer layer (see para [0084]-[0085], para [0087]), the fluid cavity being configured to accommodate a fluid (see figs. 1C-1E and para [0087]),
wherein the growable tube comprises a turnable region at a distal end, and
the inner layer and the outer layer are connected and turnable in the turnable region (see figs. 1C, 3A-3B, para [0047]);
a guide/guidance wire arranged in a channel surrounded by the inner layer of the growable tube and configured to move relative to the growable tube (see fig. 3A-3B- 44, para [0047], and para [0107]), wherein a distal end of the guide is bendable to drive the growable tube to turn (see fig. 3B and para [0107]);
a tube driving mechanism connected to the growable tube, for driving the outer layer or the inner layer of the growable tube to turn in the turnable region by means of a linear movement, thereby causing the growable tube to grow distally or withdraw proximally (see figs. 1A-1E, fig. 17D, para [0071], and para [0153]-[0154]), and wherein the surgeon/physician can control the guidance wire to guide the ballon (see para [0107]), and a guide driving mechanism connected to a proximal end of the guide, for driving the guide/guidance wire to move in the channel of the growable tube (see para [0107] – the guidance wire is configured to be controlled by the surgeon at the proximal end in order to steer the ballon and wire).
Regarding claim 3, Bacich teaches the guidable and growable instrument according to claim 1, wherein a radial dimension of the outer layer is substantially constant, gradually decreasing or decreasing in a stepwise manner along an extension direction from a proximal end to a distal end (See Bacich – figs. 1A-1D, reference number 2 and para [0091]).
Regarding claim 16, Bacich teaches the guidable and growable instrument according to claim 1, further comprising a fluid controller/fluid cooling system,
wherein the fluid controller/pressurization device is configured to pressurize or depressurize the fluid so as to drive the fluid to fill the fluid cavity of the turnable region or drive the fluid to withdraw from the fluid cavity (See Bacich - figs. 1B-1E and para [0087]).
Regarding claim 17, Bacich teaches the guidable and growable instrument according to claim 1, wherein the fluid is a liquid fluid or a gaseous fluid (para [0087]).
Regarding claim 18, Bacich teaches the guidable and growable instrument according to claim 1, wherein the growable tube is made of flexible material (See Bacich - para [0084]).
Regarding claim 19, Bacich teaches the guidable and growable instrument according to claim 1, wherein the guide further comprises a medical instrument fixedly disposed at the distal end of the guide or disposed in an internal channel of the guide (See Bacich, emphasis on the following sentence - “The inner catheter 10 can have the inner catheter lumen 12, or be a solid rod or flexible mandrel, or contain multiple lumens for the delivery of other agents, tools, catheters, instruments, endoscopes, and other media.” )
the medical instrument includes an ultrasound probe, a probe/imaging probe, a drug capsule, or a surgical end effector (See Bacich – para [0033] and para [0067]).
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.
Claims 2, 4, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bacich in view of US 2020/0142013 A1 to Wong.
Regarding claim 2, Bacich teaches the guidable and growable/extendable instrument according to claim 1, but does not explicitly disclose wherein a radial dimension of a proximal end of the outer layer is larger than or equal to a radial dimension of a distal end of the outer layer.
However, Wong teaches wherein a radial dimension of a proximal end of the outer layer is larger than or equal to a radial dimension of a distal end of the outer layer (see annotated fig. 1 below).
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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 the system of Bacich with the teachings of Wong to arrive at the claimed invention. Such modification would improve the system by ensuring the guidable instrument is able to properly maneuver through the orifice of the patient while also preventing injuries during the surgical procedure, ultimately improve surgical outcomes while preserving the health and safety of the patient.
Regarding claim 4, Bacich as modified teaches the guidable and growable instrument according to claim 1, wherein a radial dimension of the inner layer remains constant or gradually decreases along an extension direction from a proximal end to a distal end (See Wong - annotated fig. 1 below).
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Regarding claim 10, Bacich as modified teaches the guidable and growable instrument according to claim 1 that can contain cables/drive wires located between the distal end and the drive unit to control/bend the distal end of the continuum structure (See Wong - fig. 11A, 804, 818-819, and para [0070]), wherein the guide comprises a turning member/flexible body (See Wong - fig. 11A, 816) and driving wires disposed/cables within the turning member/elongated device (See Wong - fig. 11A, 804, 826, para [0067], and para [0070]),
wherein distal ends of the driving wires are connected with a distal end of the turning member/ flexible body (See Wong - annotated fig. 11A below),
and the driving wires are configured to drive the turning member/flexible body to turn in at least one degree of freedom direction under the drive of a guide driving mechanism/drive unit (See Wong - annotated fig. 11A, para [0067], and para [0070]).
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Regarding claim 20, Bacich teaches:
A guidable and growable instrument (see abstract and figs. 1A-1C) comprising:
a growable tube comprising an inner layer, an outer layer, and a fluid cavity between the inner layer and the outer layer (see para [0084]-[0085], para [0087]), the fluid cavity being configured to accommodate a fluid (see figs. 1C-1E and para [0087]),
wherein the growable tube comprises a turnable region at a distal end, and
the inner layer and the outer layer are connected and turnable in the turnable region (see figs. 1C, 3A-3B, para [0047]);
a guide/guidance wire arranged in a channel surrounded by the inner layer of the growable tube and configured to move relative to the growable tube (see fig. 3A-3B- 44, para [0047], and para [0107]), wherein a distal end of the guide is bendable to drive the growable tube to turn (see fig. 3B and para [0107]);
a tube driving mechanism connected to the growable tube, for driving the outer layer or the inner layer of the growable tube to turn in the turnable region by means of a linear movement, thereby causing the growable tube to grow distally or withdraw proximally (see figs. 1A-1E, fig. 17D, para [0071], and para [0153]-[0154]), and wherein the surgeon/physician can control the guidance wire to guide the ballon (see para [0107]), and a guide driving mechanism connected to a proximal end of the guide, for driving the guide/guidance wire to move in the channel of the growable tube (see para [0107] – the guidance wire is configured to be controlled by the surgeon at the proximal end in order to steer the ballon and wire), but does not disclose wherein the instrument is part of a surgical robotic system.
However, Wong teaches wherein a flexible catheter system comprises a medical instrument, wherein the system is robotically controlled (see fig. 11A and para [0061]).
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 the system of Bacich with the robotic control system of Wong to arrive at the claimed invention. Such modification would improve the system by allowing for more accurate and control movements of the surgical system, ultimately increasing the precision and efficiency of the medical procedure.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bacich in view of Wong, US 2005/0273085 A1 to Hinman et al. (hereinafter “Hinman”), and US 20190193260 A1 to Xu et al. (hereinafter “Xu”).
Regarding claim 5, Bacich as modified teaches the guidable and growable instrument according to claim 1, but does not disclose wherein the guide/instrument comprises at least one distal continuum structure including a distal base disk,
a distal stopping disk
and a plurality of first structural backbones, wherein the distal base disk and the distal stopping disk are arranged at an interval,
distal ends of the plurality of first structural backbones are connected with the distal stopping disk,
and proximal ends of the plurality of first structural backbones pass through the distal base disk.
However, Hinman teaches, an articulating mechanism containing articulating members and flexible segments used for guidance and steering of various medical instruments to a target location (see abstract, lines 1-5). The guide/ articulating mechanism (figs. 1B-1C) comprises at least one distal continuum structure including a distal base disk (see para 0032 and annotated fig. 1C below),
a distal stopping disk (see para 0032 and annotated fig. 1C below)
and a plurality of first structural backbones/hinges (see para 0032 and annotated fig. 1B below),
wherein the distal base disk and the distal stopping disk are arranged at an interval (see annotated fig. 1C below),
distal ends of the plurality of first structural backbones are connected with the distal stopping disk (see annotated fig. 1C below), but does not disclose wherein
the proximal ends of the plurality of first structural backbones pass through the distal base disk/segment.
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However, Xu teaches discloses a flexible continuum structure applied for medical instruments (abstract, line 1 and para 0002). The structure (fig. 1) contains a plurality of spacer disk positioned in the distal structural body at intervals (see para 0047, lines 1-9) of first structural backbones/distal structural backbones (see para 0047 and fig. 1, 113) where the proximal ends of the plurality of first structural backbones/distal structural backbones pass through the distal base disk (see annotated fig. 1 below, annotated fig. 4, and para 0057: “…..one end of the distal feedback structural backbone 191 is securely connected to a distal fixation disk 112, and the other end passes through distal spacing disks 111, a rigid tube 154 and the feedback structural backbone guide channel 192 in sequence and is then connected to the position sensor 193.”).
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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 the modified teachings of Bacich with the teachings of Hinman and Xu to arrive at the claimed invention, since such modification would improve the system by providing a flexible guide for controlling a medical instrument designed to precisely and accurately conform with the natural curvature of orifice/lumen within the human body when performing the necessary surgical procedure, ultimately protecting the health and safety of the patient.
Regarding claim 6, Bacich as modified teaches:
The guidable and growable instrument according to claim 5, but does not explicitly disclose wherein the guide further comprises:
at least one proximal continuum structure including a proximal base disk,
a proximal stopping disk and a plurality of second structural backbones, wherein the proximal base disk and the proximal stopping disk are arranged at an interval,
the proximal base disk is adjacent to the distal base disk,
proximal ends of the plurality of second structural backbones are connected with the proximal stopping disk, and distal ends of the plurality of second structural backbones pass through the proximal base disk and are fixedly connected or integrated with the proximal ends of the plurality of first structural backbones, respectively.
However, Hinman teaches wherein the guide/articulating mechanism further comprises:
at least one proximal continuum structure including a proximal base disk (see annotated fig. 1C (version 1) below),
a proximal stopping disk and a plurality of second structural backbones, wherein the proximal base disk and the proximal stopping disk are arranged at an interval (see annotated fig. 1C (version 1) below),
the proximal base disk is adjacent to the distal base disk (see annotated fig. 1C (version 1) below,
proximal ends of the plurality of second structural backbones are connected with the proximal stopping disk (see annotated fig. 1C (version 2) below), and wherein the second structural backbones are fixedly connected or integrated with the proximal ends of the plurality of first structural backbones, respectively (see annotated fig. 1C (version 2) below),
VERSION 1:
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VERSION 2:
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But does not disclose wherein the distal ends of the plurality of second structural backbones pass through the proximal base disk and are fixedly connected or integrated with the proximal ends of the plurality of first structural backbones, respectively.
However, Xu teaches wherein the distal ends of the plurality of second structural backbones pass through the proximal base disk/proximal spacer disk (see annotated fig. 1 below and para 0047: “ One end of the structural backbone is securely connected to the proximal fixation disk 162, and the other end passes through the proximal spacing disks 161, the structural backbone guide channel 151, the rigid tube 154 and the distal spacing disks 111 in sequence and is then securely connected to the distal fixation disk 112. The structural backbone guide channel 151 functions to maintain the shape of the structural backbone under a pushing or pulling force”), and are fixedly connected or integrated with the proximal ends of the plurality of first structural backbones, respectively (see annotated fig. 1 below and para 0047: “The proximal structural backbones 163 in the proximal structural body 16 are securely connected, in one-to-one correspondence, to or are the same as the distal structural backbones 113 in the distal structural body 11. Three or more structural backbones are provided for each of the proximal structural body 16 and the distal structural body 11.” ).
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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 the modified teachings of Bacich with the teachings of Hinman and Xu to arrive at the claimed invention, since such modification would improve the system by providing a flexible guide for controlling a medical instrument designed to precisely and accurately conform with the natural curvature of orifice/lumen within the human body when performing the necessary surgical procedure, ultimately protecting the health and safety of the patient.
Regarding claim 7, Bacich as modified teaches:
The guidable and growable instrument according to claim 5, but does not disclose wherein the guide further comprises:
at least one proximal continuum structure including a proximal base disk,
a first proximal stopping disk,
a second proximal stopping disk and a plurality of second structural backbones,
wherein the proximal base disk, the first proximal stopping disk and the second proximal stopping disk are arranged at intervals,
the proximal base disk is adjacent to the distal base disk,
proximal ends of the plurality of second structural backbones are fixedly connected with the second proximal stopping disk,
and distal ends of the plurality of second structural backbones pass through the first proximal stopping disk and are connected with the proximal base disk;
wherein the proximal ends of the plurality of first structural backbones pass through the proximal base disk and are connected with the first proximal stopping disk.
However, Hinman teaches wherein the guide/articulating mechanism further comprises
at least one proximal continuum structure including a proximal base disk (see annotated fig. 1D below), a first proximal stopping disk (see annotated fig. 1D below), a second proximal stopping disk and a plurality of second structural backbones (see annotated fig. 1D below), the proximal base disk is adjacent/near to the distal base disk (see annotated fig. 1D below), wherein the proximal ends of the plurality of second structural backbones are fixedly connected with the second proximal stopping disk (see annotated fig. 1D below), wherein the proximal ends of the plurality of first structural backbones are connected with the first proximal stopping disk (see annotated fig. 1D below),
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but does not disclose wherein
the distal ends of the plurality of second structural backbones pass through the first proximal stopping disk and are connected with the proximal base disk,
and
wherein the proximal ends of the plurality of first structural backbones pass through the proximal base disk.
However, Xu teaches wherein the distal ends of the plurality of second structural backbones pass through the first proximal stopping disk and are connected with the proximal base disk,
and
wherein the proximal ends of the plurality of first structural backbones pass through the proximal base disk (see annotated fig. 1 below and para 0047: “The proximal structural backbones 163 in the proximal structural body 16 are securely connected, in one-to-one correspondence, to or are the same as the distal structural backbones 113 in the distal structural body 11. Three or more structural backbones are provided for each of the proximal structural body 16 and the distal structural body 11.”).
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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 the modified teachings of Bacich with the teachings of Hinman and Xu to arrive at the claimed invention, since such modification would improve the system by providing a flexible guide for controlling a medical instrument designed to precisely and accurately conform with the natural curvature of orifice/lumen within the human body when performing the necessary surgical procedure, ultimately protecting the health and safety of the patient.
Regarding claim 8, Bacich as modified teaches
The guidable and growable instrument according to claim 5, but does not disclose wherein the guide driving mechanism is connected with the plurality of first structural backbones,
and drives the distal continuum structure to turn along different directions in space by pushing or pulling the first structural backbones.
However, Xu teaches a manually driven continuum structure (see fig. 2, 18 and para 0034: “The present invention adopts the above technical solutions, and has the following advantages: 1. the present invention proposes a manually driven flexible continuum structure with a distal end being able to turn in any arbitrary direction, the flexible continuum structure comprising a distal structural body, a middle connecting body, a proximal structural body and an articulated driving chain, wherein the distal structural body is associated with the proximal structural body via the middle connecting body, and therefore, the proximal structural body can be driven to turn in any arbitrary direction”), wherein the guide driving mechanism/drive chain is connected with the plurality of first structural backbones (see fig. 1, 11, 18, 71-73, and 113, and para 0047),
and drives the distal continuum structure (see fig. 1, 11) to turn along different directions in space by pushing or pulling the first structural backbones (see fig. 1, 11 and 18, para 0034, and para 0047 (emphasis on first two sentences and last two sentences), and para 0048).
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 the modified teachings of Bacich with the teachings of Xu to arrive at the claimed invention, since such modification would improve the system by providing a drive mechanism/drive system for controlling a guide designed to precisely and accurately maneuver the natural curvature of orifice/lumen within the human body when guiding a surgical instrument and when performing the necessary surgical procedure, ultimately protecting the health and safety of the patient.
Regarding claim 9, Bacich as modified teaches the guidable and growable instrument according to claim 6, wherein the guide driving mechanism/drive unit is connected at the most proximal end and is configured to drive the distal continuum structure to turn along different directions/positions in space (See Wong - annotated fig. 11A, para 0067, and para 0070),
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But does not disclose wherein the guide driving mechanism/drive unit is connected with the proximal stopping disk at the most proximal end and is configured to drive the proximal stopping disk to move and turn, thereby pushing or pulling the second structural backbones to drive the distal continuum structure to turn along different directions in space;
or wherein the guide driving mechanism/drive unit is connected with the plurality of second structural backbones, and drives the distal continuum structure to turn along different directions in space by pushing or pulling the second structural backbones.
However, Xu teaches wherein the guide driving mechanism/manual drive (or articulating driving chain 18) is connected with the plurality of second structural backbones, and drives the distal continuum structure to turn along different directions in space by pushing or pulling the second structural backbones (see fig. 2, 18 and para 0034: “The present invention adopts the above technical solutions, and has the following advantages: 1. the present invention proposes a manually driven flexible continuum structure with a distal end being able to turn in any arbitrary direction, the flexible continuum structure comprising a distal structural body, a middle connecting body, a proximal structural body and an articulated driving chain, wherein the distal structural body is associated with the proximal structural body via the middle connecting body, and therefore, the proximal structural body can be driven to turn in any arbitrary direction”, and claim 4).
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 the modified teachings of Bacich with the teachings of Xu to arrive at the claimed invention, since such modification would improve the system by providing a drive mechanism/drive system for controlling a guide designed to precisely and accurately maneuver the natural curvature of orifice/lumen within the human body when guiding a surgical instrument and when performing the necessary surgical procedure, ultimately protecting the health and safety of the patient.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bacich in view of Wong, Hinman, and Xu, and further in view of CN 210871456 U to Xu (hereinafter “Xu’456”).
Regarding claim 11, Bacich as modified teaches the guidable and growable instrument according to item 10, wherein the turning member/flexible body is a snake structure (See Wong -annotated fig. 11A above) that can contain bending units/linkages (para 0070), but does not disclose wherein the turning member/flexible body includes a plurality of hollow bamboo-like bending units connected in head-to-tail manner, and
and through a connecting groove and a connecting protrusion connected with each other, two adjacent bending units form a motion pair that is bendable radially;
or the turning member is a flexible sheath provided with a plurality of slit units along its extension direction at intervals, wherein each of the slit units includes at least one slit extending circumferentially along the flexible sheath;
or the turning member is a bellows, the driving wires can be disposed within and throughout the bellows, or disposed in and throughout a bellows wall of the bellows.
However, Hinman teaches wherein the turning member/articulating mechanism includes a plurality of hollow bamboo-like bending units connected in head-to-tail manner (see annotated figs. 1B-1C below, fig. 2A, 228 below, and para 0040: “As shown, the links further include channels 228 that receive the individual cables sets that control the links.”),
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but does not disclose wherein the turning member is a flexible sheath provided with a plurality of slit units along its extension direction at intervals, wherein each of the slit units includes at least one slit extending circumferentially along the flexible sheath.
However, Wong teaches wherein the turning member contains a flexible catheter/sheath (see para 0067), and in another embodiment of the invention, the instrument can contain a jacket containing a plurality of slits (see fig. 1, 124, para 0037), but does not disclose wherein a plurality of slit units along its extension direction at intervals, wherein each of the slit units includes at least one slit extending circumferentially along the flexible sheath.
However, Xu’456 teaches a colubrid device comprising a hollow round tube, wherein a plurality of slit units along its extension direction at intervals (see annotated fig. 1 below, page 3 of translated version, paragraph 2, and claim 1), and wherein each of the slit units can contain/include at least one slit extending circumferentially along the flexible sheath/ bending tube (see abstract and page 3 of translated version, paragraph 3).
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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 the modified system of Bacich with the teachings of Wong, the hollow segments of Hinman, and the slit configuration of Xu’456 to arrive at the claimed invention. Such modifications would improve the system by improving the flexibility of the guide while maneuvering the natural orifice/lumen of the patient during surgery, ultimately protecting the health and safety of the patient while performing the surgical procedure.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Bacich in view of US 2002/0107478 A1 to Wendlandt.
Regarding claim 13, Bacich teaches:
The guidable and growable instrument according to claim 1, wherein the tube driving mechanism comprises a drive unit (See Bacich – fig. 17D (everting catheter system) and para [0153]) and a transmission unit/transmission member (See Bacich - The gear wheel and traction wheel with the motor and battery – see fig. 17D and para [0153]), and wherein drive unit is configured to drive the growable tube to grow or withdraw (see para [0153]-0154] of Bacich), and wherein the driving mechanism comprises an inner catheter is sealingly connected to the inner layer in order to advance or retract the inner catheter 10 (see fig. 17D, 184 and 10, para [0145], and para [0153]-[0156]), and wherein the inner catheter at the distal end is sealingly connected with the inner layer of the growable tube (see annotated fig. 17D below and para [0145]),
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but does not explicitly disclose wherein the tube driving mechanism comprises a moving rod, and a transmission unit connected with the driving unit and the moving rod,
wherein the moving rod is sealingly connected with the inner layer or the outer layer of the growable tube,
and the transmission unit is configured to convert rotary motion of the driving unit into linear motion, so as to drive the moving rod to drive the growable tube to grow or withdraw.
However, Wendlandt teaches a self-propelling catheter introducer system for investigating a body cavity (see abstract, lines 1-2). The system (fig. 1) comprises a tube driving mechanism/control unit (see fig. 22, 320) used to control the steering section of the catheter system (see para 0061: “Control unit 34 controls the steering section 36 in a similar manner as it controls the propulsion section 22.”, para 0065, and para 0109) further comprising a drive unit/drive system (para 0108), a moving rod/inner portion (see fig. 22, 308 and para 0108), and a transmission unit/actuation wheels (see fig. 22, 324 and para 0108) connected with the driving unit/drive system (see para 0108, lines 1-4) and the moving rod/inner portion (see fig. 22, 308 and 320),
wherein the moving rod/inner portion is sealingly connected with the inner layer or the outer layer/outer portion of the growable tube (see annotated fig. 22 below),
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and the transmission unit/actuation wheels is configured to convert rotary motion of the driving unit/drive system into linear motion, so as to drive the moving rod/inner portion to drive the growable tube to grow or withdraw (see para [0107]-[0109]).
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 the system of Bacich with the teachings of Wendlandt to arrive at the claimed invention. Such modifications would improve the system by improving and allowing smooth linear control of the catheter when directing the surgical instrument in the natural orifice/lumen of the patient during surgery, ultimately protecting the health and safety of the patient performing the surgical procedure.
Regarding claim 14, Bacich as modified teaches:
The guidable and growable instrument according to claim 13, wherein the transmission unit comprises first and second rollers/actuator wheels arranged in parallel wherein the transmission unit comprises first and second rollers/actuator wheels arranged in parallel (See Bacich - fig. 17D – 172 & 182, and para [0153]-0154]), and wherein the wheels turn in order to drive the inner catheter linearly (See Bacich - para [0153] – [0156]), and wherein the proximal end of the inner catheter (see fig. 17D, 184) is disposed between first and second rollers and abuts the rollers (see fig. 17D – 172, 182, and 184, para [0145], and para [0153]-[0154]]), and wherein the inner catheter at the distal end is sealingly connected with the inner layer of the growable tube (see annotated fig. 17D below and para [0145]),
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but does not explicitly disclose
the driving unit/drive system is connected with the first and second rollers/first and second actuation wheels, respectively, for driving the first and second rollers/wheels to synchronously rotate in opposite directions at the same speed, so as to drive the moving rod to move linearly.
However, Wendlandt teaches wherein the transmission unit comprises first and second rollers/actuator wheels arranged in parallel (see para 0108 and annotated fig. 22, 324 below);
a proximal end of the moving rod is disposed between the first roller and the second roller and abuts against the first and second rollers (see annotated fig. 22 below and para 0109: “Retraction may be accomplished by attaching another thrust collar (not shown) adjacent the proximal end 6 of catheter 2 that is shaped to receive another fold located at the proximal end of the flexible tube 304.”),
and a distal end of the moving rod/inner portion is sealingly connected with the inner layer or the outer layer of the growable tube (see annotated fig. 22 below);
the driving unit/drive system is connected with the first and second rollers/first and second actuation wheels, respectively, for driving the first and second rollers/wheels to synchronously rotate in opposite directions at the same speed, so as to drive the moving rod/inner portion to move linearly (see annotated fig. 22 below, and para 0107-0109). Although the reference does not explicitly state that the wheels/gears rotate in opposite directions, one of ordinary skill in the art can conclude that a gear system must rotate in opposite directions at the same speed in order to translate rotary motion into linear motion to advance and/or retract the rod/inner portion.
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 the system of Bacich with the teachings of Wendlandt to arrive at the claimed invention. Such modifications would improve the system by improving and allowing smooth linear control of the catheter when directing the surgical instrument in the natural orifice/lumen of the patient during surgery, ultimately protecting the health and safety of the patient performing the surgical procedure.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bacich in view of Wendlandt, and further in view of US 2019/0231330 A1 to Xu et al. (hereinafter “Xu’330”).
Regarding claim 15, Wong as modified teaches:
The guidable and growable instrument according to claim 13, but does not explicitly disclose wherein the transmission unit comprises a screw slider module including a lead screw and a slider connected by threads;
the proximal end of the moving rod is fixedly connected with the slider,
and the distal end of the moving rod is sealingly connected with the inner layer or the outer layer of the growable tube;
and the driving unit is connected with the lead screw for driving the lead screw to rotate, so as to drive the moving rod to move linearly.
However, Xu’330 teaches wherein the transmission unit comprises a screw slider module/linear module (see fig. 21, 50a and para 0070) including a lead screw and a slider connected by threads (see annotated fig. 21 below and para 0070);
the proximal end of the moving rod is fixedly connected with the slider (see annotated fig. 21 below),
and the driving unit/motor driving unit (see fig. 21, 40a and para 0069) is connected with the lead screw for driving the lead screw to rotate, so as to drive the moving rod/surgical instrument system to move linearly (see fig. 21 below-10a, para 0067, lines 1-4, and para 0070),
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But does not explicitly disclose where the distal end of the moving rod is sealingly connected with the inner layer or the outer layer of the growable tube.
However, Wendlandt teaches where the distal end of the moving rod/inner portion is sealingly connected with the inner layer or the outer layer of the growable tube (see annotated fig. 22).
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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 the system of Wong with the teachings of Xu’330 and Wendlandt to arrive at the claimed invention. Such modifications would improve the system by improving and allowing smooth and controlled linear control of the catheter when directing the surgical instrument in the natural orifice/lumen of the patient during surgery, ultimately protecting the health and safety of the patient performing the surgical procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al. (US 9,421,071 B2) teaches various direct drive methods to drive an end-effector of a surgical instrument from a distance, such as controlling/driving end-effector dexterity of surgical tools/instruments in the natural orifice of a patient (see abstract).
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.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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