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 .
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.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Devaiah et al (U.S. Patent Application Publication 2018/0110404, hereinafter “Devaiah”). Devaiah teaches an endoscopic system comprising:
a first tube of an endoscopic sleeve, wherein the first tube (claim 1 defines “tubular member”) is sized to receive an imaging device (paragraph 9 “visualization system”)
a second tube of the endoscopic sleeve (figure 18 irrigation sheath 210 around the first tube) wherein the second tube is sized to connect to an irrigation system (figure 20D see irrigation assembly)
a third tube of the endoscopic sleeve wherein the third tube is sized to connect to a vacuum system (figure 20D see suction tube 220 attached to suction assembly)
a controller in communication with the vacuum system and the irrigation system, wherein the controller controls the vacuum system and the irrigation system (paragraph 83 details how user can control the irrigation/suction system with a controller)
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.
Claims 1, 4-8, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Devaiah in view of Becker et al (U.S. Patent Application Publication 2002/013699, hereinafter “Becker”). Regarding claim 1, Devaiah teaches method of forming an endoscopic device, the method comprising:
forming, by a three-dimensional (3D) printer (paragraph details that 3D printing may be used to manufacture the elements of the disclosure), a first tube of an endoscopic sleeve (claim 1 defines “tubular member”), wherein the first tube is sized to receive an imaging device (paragraph 9 “visualization system”)
forming, by the 3D printer, a second tube of the endoscopic sleeve (figure 18 irrigation sheath 210 around the first tube), wherein the second tube is sized to connect to an irrigation system (figure 20D see irrigation assembly)
and forming, by the 3D printer, a third tube of the endoscopic sleeve such that at least a portion of the third tube is mounted to one or more of the first tube and the second tube (figure 18 suction tube 220 is mounted to second tube 210), wherein the third tube is sized to connect to a vacuum system (figure 20D see suction tube 220 attached to suction assembly)
Devaiah fails to teach a method of forming an endoscopic device comprising forming a second tube of the endoscopic sleeve such that at least a portion of the second tube is mounted to the first tube.
Becker teaches a method of forming an endoscopic device comprising forming a second tube of the endoscopic sleeve such that at least a portion of the second tube is mounted to the first tube (figure 2 tube 18 is mounted to tube 22).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Devaiah with the second tube mounted to the first tube of Becker in order to prevent leakage into the visualization system should the first tube be punctured. Devaiah discloses a second irrigation tube formed to contain the inner visualization first tube, and so if an obstruction within the patient’s anatomy punctures the second tube it likely will also puncture the inner first tube, ruining the visualization ability of the device and requiring the operation to be reset with a new endoscopic sleeve. The mounting of the second tube to the first separates the tube, lowering the likelihood one puncture event affects both tubes.
Regarding claim 4, Devaiah and Becker combined teach the limitations of claim 1, and Becker further teaches a method wherein forming the second tube comprises forming an end portion of the second tube, wherein the end portion of the second tube is formed at a non-zero degree angle relative to the first tube such that the end portion of the second tube is not in direct contact with the first tube (figure 1 see that end 15 of tube 12 is formed at a non zero angle to that of tube 22, and is not in direct contact).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Devaiah with the angled end portion of the second tube in order to allow for space to attach an irrigation system to that end, allowing for the visualization system to occupy the space at the end of the first tube without coinciding with space needed for the irrigation system.
Regarding claim 5, Devaiah and Becker combined teach the limitations of claim 4, and Devaiah further teaches a method further comprising forming at least a portion of the end portion of the second tube as an irrigation system connector (figure 20D shows second tube connected to the irrigation assembly).
Regarding claim 6, Devaiah further teaches a method wherein forming the third tube comprises forming an end portion of the third tube, wherein the end portion of the third tube is formed at an angle relative to the first tube such that the end portion of the third tube is not in direct contact with the first tube (figure 21b see that left most end of tube 220 is connected to the suction assembly and not in contact with the first tube inside irrigation sheath 210).
Regarding claim 7, Devaiah further teaches a method wherein the end portion of the third tube is parallel to the end portion of the second tube (figure 21B below see that tube 220 enters the suction assembly at a level parallel to that of the second tube).
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Regarding claim 8, Devaiah further teaches a method further comprising forming at least a portion of the end portion of the third tube as a vacuum system connector (figure 21B see suction valve above).
Regarding claim 13, Devaiah and Becker combined teach the limitations of claim 1, and Devaiah further teaches a method wherein the first tube is sized to receive a light source to provide illumination for the imaging device (paragraph 102 details “light guide” within the first tube).
Regarding claim 14, Devaiah further teaches a method further comprising forming a distal end of the second tube such that the distal end is angled toward a distal end of the first tube such that the irrigation system is able to clean a lens of the imaging device (paragraph 197 details irrigation sheath 210 washing off a lens at the distal end of the first tube).
Regarding claim 17, Devaiah teaches the limitations of claim 16, but fails to teach a system wherein the second tube includes an end portion that is formed at a non-zero degree angle relative to the first tube such that the end portion of the second tube is not in direct contact with the first tube.
Becker teaches a system wherein the second tube includes an end portion that is formed at a non-zero degree angle relative to the first tube such that the end portion of the second tube is not in direct contact with the first tube. (figure 1 see that end 15 of tube 12 is formed at a non zero angle to that of tube 22, and is not in direct contact).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Devaiah with the angled end portion of the second tube in order to allow for space to attach an irrigation system to that end, allowing for the visualization system to occupy the space at the end of the first tube without coinciding with space needed for the irrigation system.
Regarding claim 18, Devaiah and Becker combined teach the limitations of claims 16 and 17, and Devaiah further teaches a system wherein the third tube includes an end portion that is formed at an angle relative to the first tube such that the end portion of the third tube is not in direct contact with the first tube and such that the end portion of the third tube is parallel to the end portion of the second tube (figure 21B below see that tube 220 enters the suction assembly at a level parallel to that of the second tube and also does not contact the first tube).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Devaiah and Becker in view of Meenakshisundaram et al (U.S. Patent Application Publication 2024/0227300, hereinafter “Meenakshisundaram”). While Devaiah and Becker combined teach the limitations of claim 1, they fail to teach a method wherein forming the endoscopic sleeve comprises forming the endoscopic sleeve at an orientation such that the first tube of the endoscopic sleeve is perpendicular to a ground surface upon which the 3D printer is positioned.
Meenakshisundaram teaches a method of reducing material usage and cost during 3D printing by orienting prints vertically rather than horizontally. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the orientation of the endoscopic sleeve during 3D printing to be vertical (perpendicular to the ground) in order to reduce cost during a printing operation. A horizontally printed tube would require support material throughout the whole inner length of the tube that would have to be removed at the end of manufacture, and a vertically oriented tube would not require the extra material or time to remove said material, lowering manufacturing cost.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Devaiah and Becker in view of 3D Systems (Figure 4 MED-AMB 10 | 3D Systems. (2022, September 28). 3D Systems. Retrieved with Internet Archive’s “Wayback Machine”). While Devaiah and Becker combined teach the limitations of claim 1, they fail to teach wherein the endoscopic sleeve is formed from MED-AMB 10 material, MED-WHT 10 material, or PRO-BLK 10 material.
The Wayback Machine reference originating from 3D Systems on September 28th of 2022 lists that MED-AMB 10 is “Biocompatible*, sterilizable, translucent and high temperature resistant”. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the methods of Devaiah and Becker to utilize MED-AMB 10 in order to incorporate biocompatibility, sterilizability, translucence, and high temperature resistance into their endoscopic sleeve design, improve the capabilities of the invention.
Claims 9-12 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Devaiah and Becker in view of Thuemen (U.S. Patent Application Publication 2024/0138654). While Devaiah and Becker combined teach the limitations of claims 1, 4, and 6, they fail to teach a method further comprising forming, by the 3D printer, a structural support for the endoscopic sleeve, wherein the structural support includes a first portion that extends between the first tube and the end portion of the second tube.
Thuemen teaches a method further comprising forming a structural support (figure 2 support element 24) for the endoscopic sleeve, wherein the structural support includes a first portion that extends between the first tube (figure 2 tube 21 pointed at with lower arrow below) and the end portion of the second tube (figure 2 tube 22 pointed at with upper arrow below).
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It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the 3D printing method of Devaiah and Becker to include forming the support between the first and second tubes of Thuemen in order to secure the first and second tubes together to ensure that the endoscopic sleeve does not separate upon entry into a patient, preventing injury associated with separation of an inserted medical device.
Regarding claim 10, Devaiah, Becker, and Thuemen combined teach the limitations of claims 1, 4, 6, and 9, and Devaiah further teaches a method wherein the first portion of the structural support is formed to be perpendicular to the first tube (figure 21B see upper portion of support element 222 (pointed at with downward arrow) below is perpendicular to the first tube (direction shown by horizontal arrow)).
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Regarding claim 11, Devaiah further teaches a method wherein the structural support includes a second portion that extends between the end portion of the second tube and the end portion of the third tube (figure 21B see that support element 222 spans between the third and second tubes, so also extends in the space between the ends of both tubes).
Regarding claim 12, Devaiah further teaches a method wherein the second portion of the structural support is formed to be parallel to the first tube (figure 21B see that lower portion of support element 222 is wrapped circumferentially around the second tube 210 which the first tube exists inside, and so is parallel to the first tube).
Regarding claim 19, Devaiah, Becker, and Thuemen combined teach the limitations of claims 16-18, and Thuemen further teaches a system further comprising a structural support (figure 2 support element 24) for the endoscopic sleeve, wherein the structural support includes a first portion that extends between the first tube (figure 2 tube 21 pointed at with lower arrow below) and the end portion of the second tube (figure 2 tube 22 pointed at with upper arrow below).
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It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the systems of Devaiah and Becker to include the support between the first and second tubes of Thuemen in order to secure the first and second tubes together to ensure that the endoscopic sleeve does not separate upon entry into a patient, preventing injury associated with separation of an inserted medical device.
Regarding claim 20, Devaiah, Becker, and Thuemen combined teach the limitations of claims 16-19, and Devaiah further teaches a system further comprising a second portion of the structural support that extends between the end portion of the second tube and the end portion of the third tube (figure 21B see that support element 222 spans between the third and second tubes, so also extends in the space between the ends of both tubes).
Claim 15 rejected under 35 U.S.C. 103 as being unpatentable over Devaiah and Becker in view of Hancock et al (U.S. Patent Application Publication 2023/0372567, hereinafter “Hancock”). While Devaiah and Becker combined teach the limitations of claim 1, they fail to teach a method further comprising cleaning an interior and an exterior of the endoscopic sleeve with alcohol.
Hancock teaches a method further comprising cleaning an interior and an exterior of the endoscopic sleeve with alcohol (paragraph 5 details use of alcohol to sterilize the inside and outside of the endoscopic sleeve).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the methods of Devaiah and Hancock to use alcohol to clean the endoscopic sleeve in order to sterilize said sleeve, reducing risk of infection to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM EST Monday-Friday.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
