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 .
Status of Claims
Claims 1-4, 6-8, 11, and 13-20 are pending, claims 5, 9-10, 12, and 21 have been cancelled, and claims 1-4, 6-8, 11, and 13-20 are currently under consideration for patentability under 37 CFR 1.104.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/10/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 11, and 13-21 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
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4, 6-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2008/0287963), in view of Kikuchi (US 2016/0331208).
Regarding claim 1, Rogers discloses a device comprising:(a) an endoscope (100, figure 1a) comprising: i) a disposable articulatable shaft (actuators…steer [0055]) comprising a proximal end and a distal end (see figure 3a) and ii) a camera module (camera as part of its distal end…[0038]) located at the distal end, wherein the proximal end is removably attached to a supporting member (108 is coupled to the platform 112 [0051]; see figure 1b) comprising or connected to a robotic arm (platform 112 of the robotic arm 158 [0051]; figure 1b); and(b) one or more disposable instruments (see 101A-C, figure 2; [0036]) connected to the endoscope, wherein at least one of the one or more disposable instruments comprises a flexible shaft (see figure 2; manipulated by actuators…[0039]); a plurality of pull wires (380, figure 3c) integrated into walls of the articulatable shaft (see 380 inside the walls of vertebrae 372-376, figure 3c) and connected to the distal end of the endoscope (cables…transfer the torque…steer the end effector 348 [0062]; see 348, figure 3a); wherein the supporting member is configured to position the device to an initial position to access a subject (support actuators…108 [0037]; tools…actuators [0039]). Rogers is silent regarding wherein the at least one of the one or more disposable instruments is connected to the endoscope through a permanent connection at a distal end of the endoscope and a distal end of the flexible shaft, wherein the permanent connection comprises a non-releasable bond between the distal end of the endoscope and the distal end of the flexible shaft, wherein the at least one of the one or more disposable instruments is not inserted into the endoscope such that the endoscope and the at least one of the one or more disposable instruments has a side-by-side configuration-and are configured into a combination device, wherein the combination device performs functions of both the endoscope and the one or more disposable instruments and an articulation movement of the combination device is controlled by the plurality of pull wires, wherein the camera module and the at least one of the one or more disposable instruments are permanently integrated to the endoscope such that there is substantially no relative movement between the camera module and the at least one of the one or more disposable instruments, wherein the device is single-use.
Kikuchi teaches a manipulator (3, figure 1) having at least one degree of freedom and a flexible cylindrical sheath (4, figure 1) mounted on the outer circumference of the manipulator ([0042]). A treatment tool (5, figure 1) is inserted through the sheath. The connector member (6, figure 9) includes a first connector member (61, figure 9) and a second connector member (62, figure 9). The first connector member may be fixed in place ([0081]). There is a fixation mechanism (7, figures 21) for fixation of the treatment tool to the sheath ([0113]). The sheath includes an inwardly extending convexity (4b, figures 21), while the treatment tool includes a concavity (51a, figures 21). The convexity (4b, figures 21) is fitted in the concavity (51a, figures 21a) for fixation of the treatment tool to the sheath ([0115]).
It would have been obvious to modify the device with the flexible cylindrical sheath (4, figure 1), the connector member (6, figure 9), and fixation mechanism (7, figures 21) to attach an instrument of Rogers to the side of the endoscope. Doing so would fix the instrument to the device/endoscope through fixation of the instrument to the sheath ([0115]) and the sheath to the endoscope ([0081]). The modified device would have wherein the at least one of the one or more disposable instruments is connected to the endoscope through a permanent connection (first connector member 61…fixed in place [0081]; see figure 9 of Kikuchi | see tool 5 fixed to sheath 4, figures 21) at a distal end of the endoscope and a distal end of the flexible shaft (see 61 with respect to 3 and 4, figure 9; Kikuchi), wherein the permanent connection comprises a non-releasable bond (61…fixed in place [0081]) between the distal end of the endoscope and the distal end of the flexible shaft (see figure 21 | interpreted the fixation mechanism 7 can be non-releasable if the cable 5a is not let out [0115]), wherein the at least one of the one or more disposable instruments is not inserted into the endoscope such that the endoscope and the at least one of the one or more disposable instruments has a side-by-side configuration (see figure 9) and are configured into a combination device (see figure 9; Kikuchi), wherein the combination device performs functions of both the endoscope (100, figure 1a | see 101, figure 3a of Rogers) and the one or more disposable instruments (5, figure 9; Kikuchi | robotic instruments…surgical tools…[0039]; Rogers) and an articulation movement of the combination device is controlled by the plurality of pull wires (control cables to robotically steer the distal end [0037]; Rogers), wherein the camera module (camera as part of its distal end…[0038]; Rogers) and the at least one of the one or more disposable instruments are permanently integrated to the endoscope (first connector member 61…fixed in place [0081]; see figure 9 of Kikuchi | see tool 5 fixed to sheath 4, figures 21) such that there is substantially no relative movement between the camera module and the at least one of the one or more disposable instruments (would have substantially no relative movement between the endoscope 101 in figure 3a of Rogers and instrument 5 in figure 9 of Kikuchi), wherein the device is single-use (see endoscope 101, figure 3a of Rogers and 4-5, figure 9 of Kikuchi can be single-use or disposed after one use).
Regarding claim 2, Rogers further discloses the distal end of the endoscope is articulated in two or more degrees of freedom (see figure 4A, [0037]; steer…[0055]; Rogers).
Regarding claim 4, Rogers further discloses the one or more disposable instruments are one or more instruments selected from the group consisting of a morcellator, scissors (instruments…scissors [0030]; Rogers), a needle (treatment tool…needles [0074]; Kikuchi), an illumination source, a laser, a balloon, an implant/stent delivery device, a stitching device, laser fibers, a grasper, snares, a loop, and a bucket.
Regarding claim 6, Rogers and Kikuchi further disclose the camera module is configured to provide a stationary view (camera as part of its distal end…[0038]; Rogers) of the one or more disposable instruments (see location of 5 relative to 3, figure 9; Kikuchi).
Regarding claim 7, Rogers further discloses the camera module is fixed relative to the one or more disposable instruments (camera as part of its distal end…[0038]; Rogers).
Regarding claim 8, Rogers further discloses the proximal end of the device comprises a mechanical interface (108 is coupled to the platform 112 [0051]; see figure 1D; Rogers) connected to the robotic arm.
Regarding claim 11, Rogers further discloses the supporting member is configured to control functions of the endoscope and the one or more disposable instruments (figure 1a; [0044]; Rogers).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2008/0287963) and Kikuchi (US 2016/0331208) as applied to claim 1 above, and further in view of Malchano (US 9,468,364).
Regarding claim 3, Rogers and Kikuchi disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the at least one of the one or more disposable instruments is an implant delivery device.
Malchano teaches an endoscope (108, figure 7) with a working channel (Col.13, line 31). The working channel of the endoscope can be used to introduce implantable devices or tools, like implants or stents (Col. 13, lines 31-38).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device of Rogers and Kikuchi to utilize an implantable device or tool (Col. 13, lines 31-38) as taught by Malchano. Doing so would provide tools that can be used for diagnosis and/or treatment of target tissue (Col. 13, lines 31-38).
Claim(s) 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2008/0287963) and Kikuchi (US 2016/0331208) as applied to claim 1 above, and further in view of Allen (US 2016/0256181).
Regarding claim 13, Rogers and Kikuchi disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the at least one of the one or more disposable instruments is a morcellator.
Allen teaches a morcellator (12, figure 3), where the morcellator can be semi-rigid ([0030]). Further, the morcellator can be curved along the longitudinal axis ([0030]). A morcellator can remove tissue while reducing bleeding and trauma to surrounding tissue ([0008]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify one of the instruments (see 101A-C, figure 2; [0036]) of Rogers to be a morcellator (12, figure 3) as taught by Allen. Doing so would allow for removing tissue while reducing bleeding and trauma to surrounding tissue ([0008]). The modified device would have the at least one of the one or more disposable instruments is a morcellator (12, figure 3; Allen).
Regarding claim 14, Rogers further discloses the device is configured to provide a stationary view of the morcellator (camera as part of its distal end…[0038]; to view end effectors [0099]; Rogers).
Regarding claim 15, Allen further teaches the morcellator is pre-bent (semi-rigid…curved [0030]; figure 4; Allen).
Regarding claim 16, Rogers further discloses the camera module resides at a neck area of the morcellator (based on the distance of the distal end of the morcellator from the distal end of the endoscope, the camera module can be located around the neck area of the morcellator; see figure 2 of Rogers).
Regarding claim 17, Allen and Rogers further disclose the morcellator comprises an articulatable shaft (semi-rigid [0030]; Allen | [0054]; Rogers).
Regarding claim 18, Rogers further discloses the articulatable shaft is articulated in two or more degrees of freedom (310 are associated with a degree of freedom of the tool [0061]; figure 3b).
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2008/0287963) and Kikuchi (US 2016/0331208) as applied to claim 1 above, and further in view of Mathis (US 2005/0288550).
Regarding claim 19, Rogers and Kikuchi disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the permanent connection is formed using an adhesive material.
Mathis teaches a flexible bronchoscope (40, figure 17) with a guide element (44, figure 17) operably connected to the distal end of the bronchoscope to direct delivery of an instrument outside said bronchoscope to an area ([0008]). A separable attachment device, such as a clip, an adhesive, a strap, and a sleeve, allows controlled release of the guide element when placed inside the subject’s target area or surrounding tissue ([0013]). A variety of instruments can be used in conjunction with the assembly ([0014]).
It would have been obvious to one of ordinary skill in the art to modify the device of Rogers and Kikuchi to have the permanent connection be formed using an adhesive material ([0033]) as taught by Mathis. Doing so would be an alternative means for attachment ([0013]). The modified device would have the permanent connection is formed using an adhesive material (adhesive 92; figure 17; [0033]; Mathis).
Regarding claim 20, Mathis further teaches the adhesive material is biocompatible (adhesive 92…inserted into the lung…[0033]; Mathis).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
August 7, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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