Examiner’s Comments
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
Applicant’s amendments and remarks in the reply filed 3/16/2026 have been acknowledged and entered. Claims 1-7, 9-14, 17-19, 21, 22, and 24 are pending. Claims 1-6, 7, and 9-12 are withdrawn.
As pointed out by applicant, it is noted that claim 14 was not addressed in the previous Office action. Applicant has rewritten claim 14 in independent form as claim 24. Claim 24 is addressed below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over US 10245339 B2 to Shin et al in view of US10543058B2 to Bauco et al, US 20190224357 A1 to Sundet et al, WO 2020123679 A1 to Miller et al, and US 2009/0000045 to Kanno et al.
Regarding Claim 13: Shin discloses a method for disinfecting an endoscope or a catheter having a channel defined by an inner surface, (See Shin, Abstract, Col. 3, Lines 4-6, which discloses a method for cleaning the interior of a medical instrument which may be an endoscope)
the method comprising: transmitting an ultra-violet (UV) light from an elongate radial diffuser positioned in proximity to a distal end of the inspection scope, (See Shin, Abstract, Col. 2, Lines 29-62, Fig. 6, ref. #26, which discloses that UVC light (a type of UV light) is emitted through an optic fiber with a reflective attachment secured to a distal end to direct light)
the transmission of the UV light causing emission of the UV light in a radial illumination pattern on the inner surface of the channel of the endoscope or the catheter, the radial illumination pattern of UV light on the inner surface of the channel serving to irradiate and disinfect the inner surface (See Shin, Abstract, Col. 2, Lines 29-62, Fig. 6, ref. #24, 26, which discloses that light is emitted radially outward from the central longitudinal axis; therefore, light would be emitted in a cylindrical pattern inside the endoscope).
Shin fails to disclose the transmitted UV light being transmitted according to a determined UV light energy dwell time.
However, Bauco discloses a medical device cleaning tool which comprises a cylindrical optical diffuser, possessing a length, having an outer surface and an end optically coupled to the light source to transmit UV light from its surface (See Bauco, Claim 13, Col. 2, Lines 28-41, Fig. 1, ref. # 12). Bauco also discloses that the UV light can be configured to transmit light of a certain wavelength (See Bauco, claims 10-12, Col. 20, Lines 8-15) at various lengths of time depending on the type of bacteria present (See Bauco, Col. 17, Lines 25-56). It would have been obvious to one of ordinary skill in the art to modify the cleaning device of Shin to emit the UV light at a pre-determined level and time, as the transmission of light at a pre-determined wavelength ensures that the light emitted is within the proper wavelength to effectively kill bacteria, fungi, and viruses (See Bauco, Col. 3, Lines 34-60).
Shin/Bauco fails to disclose the inspection scope including a visualization member; and wherein the visualization member is configured to acquire images of the inner surface of the channel and detecting an irregularity on the inner surface of the channel with the acquired images from the visualization member, and determine an ultra-violet (UV) light energy dwell time based on the type of irregularity.
However, Sundet discloses a medical device inspection system which possesses a camera and computer processor. Said system allows the processor to identify abnormalities within a medical device based on images captured by the camera, label them, and suggest a course of corrective action (See Sundet, Paragraphs [0037]-[0043]). Since the combination of Shin and Bauco discloses that the amount and time of UV light exposure may be altered in order to clean the lumen, it is reasonably expected that the combination of Shin, Bauco, and Sundet would result in changing the UV dwell time in response to the image identification. It would have been obvious to one of ordinary skill in the art to have modified the device of Shin and Bauco with the visualization member, computer, and processor of Sundet as manually inspecting and cleaning endoscope lumens can be labor intensive, ineffective, and can possibly result in damage to the lumen. Therefore, the proposed combination renders a more effective, automated endoscope cleaning device.
Shin/Bauco fails to disclose automatically feeding an inspection scope through the channel with an auto feed drive mechanism. However, Sundet discloses a medical device inspection system wherein a controller controls the feeder to automatically advance into the lumen in incremental steps to clean while advancing (See Sundet, Paragraph [0008]). It would have been obvious to one of ordinary skill in the art to have modified the device of Shin/Bauco to be auto-fed into the lumen of the medical device as taught by Sundet in order to reduce the need of human involvement in the process, reducing error, and ensuring that the device is fed through the lumen at a consistent speed.
Shin/Bauco/Sundet fails to disclose wherein the determined rate at which the inspection scope is automatically fed through the channel with the auto feed drive mechanism is determined based at least in part on one or more AI algorithms, executed by a processor, which one or more artificial algorithms are configured to analyze at least one of the acquired images or operational data, and the determined rate is electronically controlled and adjusted to regulate a dosage of UV light delivered to an internal surface of the channel, such that a UV light energy dwell time is controlled in terms of on/off cycles, pulsing, and intensity to achieve a desired disinfection.
However, Miller discloses an endoscope cleaning tool wherein the tool is moved translationally within the endoscope at a fixed or variable velocity by a programmable motor (electronically controlled) in order to adjust the amount of time, and resultantly the dosage, that the lumen is cleaned with UV light. In one embodiment, the motor is programmed to withdraw the catheter in a series of discrete steps, i.e. , holding the catheter in place for a specified period of time and then withdrawing it a specified distance and repeating this step (which would constitute a pulsed cycle) until it has been withdrawn and the disinfection procedure is complete. Energy within a certain ultraviolet-C light spectrum from one of the light sources might also be delivered (See Miller, Paragraphs [0098]-[0090], Fig. 5, ref. #110).
Kanno further teaches a method of cleaning an inside of an endoscope channel with a feeding device which varies a feed rate of the cleaning tool such that optimum configuration can be chosen to improve a cleaning effect depending on the contamination level of the endoscope [0015, 0053]. Since Shin and Sundet disclose that a controller identifies an irregularity and suggests a course of corrective action, the combination with Miller results in a medical device cleaning tool which translational speed of the tool is determined by the controller. Miller teaches the use of artificial intelligence to record an image and a recommended course of corrective action pertaining to an identified defect in the lumen of the medical device [0043]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shin, Bauco, and Sundet with the adjustable translational speed and UV light intensity and dwell time to ensure that the pathogens in the lumen of the medical device are properly treated and to optimize the full kill power of the disinfection system based on the pathogen (See Miller, Paragraph [0099]). It would have been further obvious to one of ordinary skill in the art to modify the prior art method wherein the feed rate is determined based at least in part on one or more artificial intelligence algorithms that are configured to analyze at least one of the acquired images or other operational data in order to dynamically adjust the feed rate of the cleaning tool as needed, as suggested by Sundet and Kanno.
Allowable Subject Matter
Claims 13, 14, 17-19, 21, and 22 are allowed.
The following is an examiner’s statement of reasons for allowance: the reviewed prior art does not anticipate or fairly suggest an inspection scope or method for inspection having all features as set forth in the pending claims. The closest prior art of record is that of Shin who teaches transmitting a UV light from a radial diffuser positioned in proximity to a distal end of the inspection scope to irradiate and disinfect the inner surface. As pointed out by applicant (see 3/16/2026 remarks), the cited prior art does not teach or fairly suggest determining a contamination level using one or more artificial intelligence algorithms executed by a processor based on real-time image analysis, and determining a location within the channel as a distance from an opening of the channel based on operational data from the auto feed drive mechanism, identifying the type of device being disinfected, and dynamically adjusting the UV light dosage as required by claim 13.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATASHA CAMPBELL whose telephone number is (571)270-7382. The examiner can normally be reached Monday-Friday 9:00 AM- 5:00 PM EST.
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/NATASHA N CAMPBELL/Primary Examiner, Art Unit 1714
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