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 Amendment
Amendments to claim 1 of 8/29/2025 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 8/29/2025 have been fully considered but they are not persuasive.
Regarding p. 6, para. 6, applicant asserts that Ueno lacks the linear translation nuts mounted on the shaft. However, Ueno shows in fig. 1, 7-10 a linear translation nut member 62a-d disposed on the shaft 56a-d.
Regarding p. 7, para. 1, applicant asserts that a transmission is not taught. Examiner is not in accordance in as much as a force transmitting system having a shaft with linear translation nuts mounted as recited in the claims is taught. Though the term “transmission” may refer to a mechanical gearbox device outside of the art, the recitation of a “transmission system” could be interpreted to mean a system for transmitting any number of things, be it force, light, etc.. If specifically a transmission to mean the mechanical gearbox is meant, then it would be advisable for a gear system to be positively recited in the independent claim or for a synonym to be substituted.
Regarding p. 7, para. 2, examiner clarifies in the discussion of p. 6, para. 6 that the nut elements of Ueno would be elements 62a-d, not 56a-d as applicant is inclined to believe. Elements 56a-d would be the rotatable shaft that applicant claims is not present.
Applicant’s arguments with respect to claim(s) 1 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 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, 12-13, 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueno (20080119695 A1) in view of Edminster (US 20180256851 A1) and Nakaichi (US 6004263 A).
Regarding claim 1, Ueno teaches A rapid exchange endoscope assembly, comprising:
a transmission system (fig. 7, element 52) having a shaft (fig. 7, element 56a-d) with two linear translation nuts (fig. 1, element 62a-d, [0072], four nut members 62a-d)
a first endoscopic tip control wire (fig. 8, element 14, [0041]) attached to one of the two linear translation nuts;
a second endoscopic tip control wire attached the second of the two linear translation nuts (fig. 8, element 14, [0041], each linear translation nut is disposed with one wire attached);
a control handle (fig. 2, element 8b, [0038]) with a detachment mechanism (fig. 2, element 33, [0052]), the detachment mechanism accepting and locking the transmission system into an attached position;
Ueno does not explicitly teach a device wherein the nuts are mounted on oppositely threaded portions of the shaft so that rotation of the shaft in one direction moves the two linear translation nuts further away from one another and rotation of the shaft in an opposite direction moves the two linear translation nuts closer together; and
releasing the transmission system from the control handle via a button;
a mechanical actuator associated with the control handle having a rotation mechanism to rotate the shaft of the transmission system when the transmission system is in the attached position, wherein the actuator mechanically couples to the transmission system when the transmission system is in the attached position to control the rotation of the shaft when the mechanical actuator is driven by an operator and provide mechanical feedback through the actuator to the operator.
However, Edminster teaches a device wherein the nuts (fig. 3, element 60, 61, [0032]) are mounted on oppositely threaded portions of the shaft so that rotation of the shaft in one direction moves the two linear translation nuts further away from one another and rotation of the shaft in an opposite direction moves the two linear translation nuts closer together ([0033-34]);
a mechanical actuator (fig. 3, element 18, 19, [0027], distal/proximal actuator) associated with the control handle having a rotation mechanism ([0027], dial and internal components that can be rotationally manipulated in opposing directions) to rotate the shaft of the transmission system when the transmission system is in the attached position, wherein the actuator mechanically couples to the transmission system when the transmission system is in the attached position to control the rotation of the shaft when the mechanical actuator is driven by an operator ([0027], tensioning lines 20 are controlled by rotation of the actuators to control bending of the guide tube) and provide mechanical feedback through the actuator to the operator ([0027], rotation by an operator would result in a tactile feedback by definition).
However, Nakaichi teaches releasing the transmission system from the control handle via a button (fig. 9, 10, element 33, col, 10, ln. 29-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive shaft of Ueno to include a second drive nut on the same shaft in order to reduce the number of required inputs and allow operation with one hand (Edminster [0025]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the detachment mechanism of Ueno to incorporate a button as taught in Nakaichi in order to releasably connect the operating and insertion portions (col. 3, ln. 62 – col. 4, ln. 2).
Regarding claim 12, Ueno in view of Edminster and Nakaichi teaches The system of claim 1,
Ueno further teaches the system comprising an insertion tube (fig. 2, element 8a) extending from the transmission system, an endoscopic tip of the insertion tube being connected to the first and second endoscopic tip control wires ([0045], motors 19a-d drive control nuts, which are attached to control wire that drive the tip in four directions of bending).
Regarding claim 13, Ueno in view of Edminster and Nakiachi teaches The system of claim 12,
Further, Nakaichi teaches the system wherein the insertion tube is configured to fit into and carry an endotracheal tube (col. 8, ln. 40-61).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ueno to deliver an endotracheal tube as taught in Nakaichi in order to insert the tube into the trachea while visually observing the body cavity of the patient (Nakaichi col. 1, ln. 56-64).
Regarding claim 16, Ueno in view of Edminster and Nakaichi teaches The system of claim 1,
Further, Nakaichi teaches the system comprising a diameter in the insertion tube and the outer housing of the transmission that allows for rapid removal of overtubes through the detachment end (col. 8, ln. 40-61, endoscope delivers an endotracheal tube, which is a type of overtube).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ueno to deliver an endotracheal tube as taught in Nakaichi in order to insert the tube into the trachea while visually observing the body cavity of the patient (Nakaichi col. 1, ln. 56-64).
Regarding claim 17, Ueno in view of Edminster and Nakaichi teach The system of claim 1,
Edminster further teaches the device wherein the shaft of the transmission is the only shaft in the transmission (fig. 4, element 49, [0032], drive shaft 49 is the only shaft shown. Guide tube 12 is shaft-like, but would not be considered a part of the transmission).
Regarding claim 18, Ueno in view of Edminster and Nakaichi teach The system of claim 1,
Further, Edminster teaches the device wherein the actuator comprises a manual control knob (fig. 4, element 18/19, [0027], distal/proximal actuators coupled to steering mechanism to control wire tensioning) on the control handle configured to control an endoscopic tip of an insertion tube extending from the transmission system.
Regarding claim 19, Ueno in view of Edminster and Nakaichi teach The system of claim 1,
Further, Edminster teaches the device wherein the control knob is mechanically connected through gears (fig. 5, element 45, 47, [0032], knob has teeth 45 that mate with gear 47 disposed upon the shaft) to the shaft to provide mechanical feedback to an operator of the control knob.
Claim(s) 2-11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueno in view of Edminster as applied to claim1 above, and further in view of DeGuillebon (US 6595984 B1).
Regarding claim 2, Ueno in view of Edminster and Nakaichi teaches The system of claim 1,
Ueno in view of Edminster does not explicitly teach the system wherein the detachment mechanism and the transmission system are configured such that the transmission system can be inserted into the attached position independent of orientation.
However, DeGuillebon teaches the system wherein the detachment mechanism (fig. 2, element 44, col. 5, ln. 15-43) and the transmission system are configured such that the transmission system can be inserted into the attached position independent of orientation (col. 5, ln. 15-43, a plurality of radial bores {explicitly one or more} are configured to accept the detent member 52, which would allow for a plurality of valid connection positions).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting member of Ueno to include a plurality of radial bores and detents as taught in DeGuillebon in order to optimize gripping power of the connecting portion (DeGuillebon col. 5, ln. 15-43).
Regarding claim 3, Ueno in view of Edminster and Nakaichi teaches The system of claim 1,
wherein the transmission system comprises:
a chamber (fig. 7, element 53, 54, [0065], frame forms a chamber) configured to guide the two linear translation nuts.
Ueno in view of Edminster does not explicitly teach an outer housing having a plurality of detents located to interact with one or more ball bearings of the detachment mechanism;
However, DeGuillebon teaches an outer housing having a plurality of detents (fig. 3, element 52, 54, col. 5, ln. 15-43, explicitly one or more detents and bores, the number of which can be selected to optimize gripping power) located to interact with one or more ball bearings of the detachment mechanism;
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting member of Ueno to include a plurality of radial bores and detents as taught in DeGuillebon in order to optimize gripping power of the connecting portion (DeGuillebon col. 5, ln. 15-43).
Regarding claim 4, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 3,
Further, Ueno teaches the system wherein the transmission system comprises a drive connector (fig. 5, element 31a, [0056]) that extends out from one end of the outer housing that interacts with the rotation mechanism.
Regarding claim 5, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 4,
wherein the transmission system comprises a tube connector (fig. 2, element 18, [0045]) on an opposite end of the outer housing.
Regarding claim 6, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 3, wherein the outer housing is elongate and cylindrical and approximately the diameter or slightly larger an endoscope insertion tube (fig. 2, element 16, 18, [0045], lock ring 33 is configured to slide over the coupling section 16 and accommodate it, thus the internal diameter must be slightly larger than the diameter of the insertion portion).
Regarding claim 7, Ueno in view of Edminster and Nakaichi teaches The system of claim 1,
Further, Nakaichi teaches the system wherein the detachment mechanism comprises:
a tube (fig. 9, element 2e) that accepts an outer housing of the transmission system, the tube being within a button housing (fig. 9, element 2) that includes a button (fig. 9, element 33, col, 10, ln. 29-49);
Ueno, Edminster, and Nakaichi do not explicitly teach the system wherein at least one ball bearing held by the button housing, sized to interact with at least one hole in the tube;
upper and lower springs biasing the tube with respect to the button housing in a position that aligns the at least one ball bearing into the at least one hole, wherein the button is configured to accept upward force to compress the upper spring and move the at least one ball bearing out of the at least one hole.
However, DeGuillebon teaches the system wherein at least one ball bearing (fig. 3, element 52) held by the button housing, sized to interact with at least one hole (fig. 3, element 54, col. 5, ln. 15-43) in the tube;
upper and lower springs biasing the tube with respect to the button housing in a position that aligns the at least one ball bearing into the at least one hole, wherein the button is configured to accept upward force to compress the upper spring and move the at least one ball bearing out of the at least one hole (Nakaichi col, 10, ln. 29-49, button is biased by a spring).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting member of Ueno to include a plurality of radial bores and detents as taught in DeGuillebon in order to optimize gripping power of the connecting portion (DeGuillebon col. 5, ln. 15-43).
Regarding claim 8 as best understood, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 7,
Further, DeGuillebon teaches the system wherein the at least one ball bearing comprises a plurality of ball bearings arranged at a plurality of angular positions around the button housing and the at least one hole comprises a plurality of holes and at the plurality of angular positions (fig. 3, element 52, 54, col. 5, ln. 15-43, explicitly one or more detents and bores, the number of which can be selected to optimize gripping power).
Regarding claim 9, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 7,
wherein the outer housing of the transmission system comprises a pattern of detents or hollows to engage at least one ball bearing (fig. 3, element 52, 54, col. 5, ln. 15-43, explicitly one or more detents and bores, the number of which can be selected to optimize gripping power).
Regarding claim 10, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 9,
wherein the pattern of detents surrounds the outer housing of the transmission system (fig. 3, element 52, 54, col. 5, ln. 15-43, explicitly one or more detents and bores, the number of which can be selected to optimize gripping power).
Regarding claim 11, Ueno in view of Edminster, Nakaichi, and DeGuillebon teaches The system of claim 9,
Further, Ueno teaches the system wherein the outer housing comprises electrical contacts connected to electrical leads embedded in the outer housing and extending into an insertion tube connected to the transmission system (fig. 1, element 21, [0045] shows clear break points where two contacts of CCD cable 21 are attached at the separable position).
Regarding claim 15, Ueno in view of Edminster and Nakaichi teaches The system of claim 1,
Ueno in view of Edminster and Nakaichi does not explicitly teach a system comprising
ball bearing to detent connections between the transmission and the detachment system that provide multi-orientation insertion and default to a secured locked position .
However, DeGuillebon teaches a system comprising
ball bearing to detent connections between the transmission and the detachment system that provide multi-orientation insertion and default to a secured locked position (fig. 3, element 52, 54, col. 5, ln. 15-43, explicitly one or more detents and bores, the number of which can be selected to optimize gripping power).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting member of Ueno to include a plurality of radial bores and detents as taught in DeGuillebon in order to optimize gripping power of the connecting portion (DeGuillebon col. 5, ln. 15-43).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueno in view of Edminster and Nakaichi as applied to claim13 above, and further in view of Molnar (ES 2899899 T3).
Regarding claim 14, Ueno in view of Edminster and Nakaichi teaches The system of claim 13,
Ueno in view of Edminster and Nakaichi does not explicitly teach the system wherein the insertion tube is configured to allow exchange of endotracheal tubes in vivo when the control handle is detached.
However, Molnar teaches the system wherein the insertion tube is configured to allow exchange of endotracheal tubes in vivo when the control handle is detached (fig. 22, element 926, p. 13, para. 7-9, p. 14, para. 1-2, tube changer 926 is provided with a mechanism by which endotracheal tubes may be removed and a new one fed into the trachea).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ueno to include a tube exchanger as taught in Molnar in order to replace an endotracheal tube during use (Molnar p. 14, para. 1).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edminster in view of Ueno and Nakaichi as applied to claim19 above, and further in view of Kindler (EP 2702926 A1).
Regarding claim 20, Ueno in view of Edminster and Nakaichi teach The system of claim 19,
Further, Edminster teaches the device wherein the gears comprise a first gear (fig. 5, element 45, [0032], actuators could be considered gears themselves in that they are toothed wheels) having a common axis of rotation with the control knob and that transmits rotation of the control knob to at least one additional gear (fig. 5, element 47, [0032], gear 47) having the common axis of rotation with the control knob,
Ueno, Edminster, and Nakaichi do not explicitly teach the device wherein the at least one additional gear is meshed with a bevel gear on the shaft that changes the axis of rotation to be aligned with that of an axis of rotation of the shaft.
However, Kindler teaches the device wherein the at least one additional gear (fig. 5, element 38, p. 1, para. 3, gear 35 attached to knob shaft 34 is offset by 90 degrees from the gear 38, which it rotates and transmits drive power to gears 39, 40) is meshed with a bevel gear on the shaft that changes the axis of rotation to be aligned with that of an axis of rotation of the shaft.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive system of Ueno to include an offset gear as taught in Kindler in order to form corresponding movements of the distal shaft by the movement of the knob (Kindler p. 1, para. 3)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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, Michael Carey can be reached on 5712707235. 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.
/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795