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 1-8, 11, and 13-21 are pending, claims 9-10 and 12 have been cancelled, and claims 1-8, 11, and 13-21 are currently under consideration for patentability under 37 CFR 1.104. Previous 35 USC 112 Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 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, 4-8, 11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2008/0287963), in view of Krimsky (US 2018/0338676).
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 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]), and 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 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 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 a plurality of pull wires connected to the distal end of the endoscope.
Krimsky teaches a surgical system (10, figure 3) with a bronchoscope (30, figure 3). A coupling device (100, figure 3) couples the distal portion (30b, figure 3) of the bronchoscope with a distal portion (50b, figure 3) of the surgical instrument (50, figure 3). The surgical instrument may be a catheter, a stapler, an ablation instrument, an ultrasonic tool, a biopsy tool, etc. ([0035]). The coupling device has an inner surface (102, figure 5) of the first portion (100a, figure 5) that is fabricated from a pliable, high-friction material to assist in inhibiting or preventing movement of a bronchoscope (30, figure 5) within and relative to the first passageway (104, figure 5).
It would have been obvious to one of ordinary skill in the art before the time of filling to modify the device of Rogers to have a variety of instruments that can be connected to the distal end of the endoscope through a coupling device (100, figure 3) as taught by Krimsky. Doing so would provide the ability to use additional surgical instruments with the endoscope when the lumen(s) of the endoscope are occupied ([0005]). The modified device would have the at least one of the one or more disposable instruments (50, figure 3; Krimsky) is connected to the endoscope through a permanent connection (see 100, figure 3) at a distal end of the endoscope and a distal end of the flexible shaft (see figure 3), wherein the at least one of the one or more disposable instruments is not inserted into the endoscope (see 50, figure 3) such that the endoscope and the at least one of the one or more disposable instruments has a side-by-side configuration (see figure 3); and are configured into a combination device (see figure 3), wherein the combination device performs functions of both the endoscope and the one or more disposable instruments (endoscope…use additional surgical instruments [0005]) and an articulation movement of the combination device is controlled by a plurality of pull wires connected to the distal end of the endoscope (control cables to robotically steer the distal end [0037]; Rogers | steering the distal end of the endoscope would also steer the distal end of the instrument).
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 and Krimsky further disclose the one or more disposable instruments are one or more instruments selected from the group consisting of a morcellator, scissors ([0030]; Rogers | instrument 50, figure 3; Krimsky), a needle, 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 5, Krimsky further teaches the camera module and the one or more disposable instruments are permanently integrated to the endoscope (see figure 3; Krimsky | inner surface 102…preventing movement of a bronchoscope…[0043]; tubular linings….affect the resistance to sliding of a surgical instrument…[0048]), and wherein there is substantially no movement between the camera module and the one or more disposable instruments (preventing movement of a bronchoscope…[0043]; resistance to sliding of a surgical instrument…[0048]).
Regarding claim 6, Rogers and Krimsky 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 (move the biopsy tool…along second axis X2 [0050], figure 2; Krimsky | the distal end of the instrument may be viewed by the camera module).
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).
Regarding claim 21, Rogers further discloses the device is single-use (the device can be single-use or thrown away after one use; see 108, figure 1d; Rogers).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers (US 2008/0287963) and Krimsky (US 2018/0338676) as applied to claim 1 above, and further in view of Malchano (US 9,468,364).
Regarding claim 3, Rogers and Krimsky 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 Krimsky 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 Krimsky (US 2018/0338676) as applied to claim 1 above, and further in view of Allen (US 2016/0256181).
Regarding claim 13, Rogers and Krimsky 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 and Krimsky 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, Rogers and Allen 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 Krimsky (US 2018/0338676) as applied to claim 1 above, and further in view of Mathis (US 2005/0288550).
Regarding claim 19, Rogers and Krimsky 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 Krimsky 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
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 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
November 15, 2025
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795