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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/28/2025 has been entered.
Claims 1-7, 9-14, 17-19, and 21-22 are pending.
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.
Claims 13, 17, 21-23 are 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 a 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. #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 propsed 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.
Regarding Claim 17: Shin discloses wherein the UV light comprises UVC light (See Shin, Claim 1, Fig. 6, ref. #24, 26).
Regarding Claim 21: Shin fails to disclose using a computer processor configured with one or more artificial intelligence algorithms, wherein the one or more artificial intelligence algorithms are configured to detect the irregularity on the inner surface of the channel by analyzing the acquired images and comparing the irregularity to a set of pre- learned shapes and patterns stored in a memory of the computer processor.
However, Sundet discloses a medical device inspection system which possesses a camera and computer processor with artificial intelligence capabilities. Said system allows the processor to identify abnormalities within a medical device based on images captured by the camera, and label them based on learned shapes stored in the system’s processor (See Sundet, Paragraphs [0037]-[0043]). It would have been obvious to one of ordinary skill in the art to have modified the device of Shin with the artificial intelligence engine 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.
Regarding Claim 22: The combination of Shin and Sundet in the rejection of claim 21 discloses further comprising using artificial intelligence to classify the irregularity according to a type, wherein the type of irregularities include at least one of normal, kinked, wet, gouged, debris-containing, and unidentified shapes (See Sundet, Paragraphs [0037]-[0043], which discloses that some examples of the method involve using the artificial intelligence to distinguish differently labeled shapes within the lumen of the medical device, where the differently labeled shapes may include normal, gouged, wet, and debris-containing).
Claims 18-19 are 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 20090000045 to Kanno et al as applied to claim 13 above, and further in view of JP2005270142A to Suzuki et al.
Regarding Claim 18, Shin discloses that the tool is advanced through the lumen, but fails to disclose wherein advancing the inspection scope comprises advancing the inspection scope at a fixed speed.
However, Suzuki discloses an endoscope cleaning device, which is advanced towards the lumen by a motor operated by a control circuit (See Suzuki, Paragraph [0032]-[0033], [0044]-[0046], Fig. 4, ref. # 22, 59). Since the motor is operated by a control circuit and motor speed is a well-known controllable variable, it is reasonably expected that the speed may be controlled to be constant. It would have been obvious to one of ordinary skill in the art to have modified the cleaning device of Shin to advance through the lumen of the medical device at a constant speed. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Regarding Claim 19: Shin fails to disclose wherein the inner surface of the channel is radiated for a predetermined amount of time.
However, Suzuki discloses an endoscope cleaning device which cleans the lumen of an endoscope for a predetermined period of time before issuing a stop signal (See Suzuki, Paragraphs [0062]-[0063], Fig. 1, ref. #200). It would have been obvious to one of ordinary skill in the art to have modified the cleaning device of Shin to disinfect the interior of an endoscope for a predetermined period of time in order to automate the cleaning process. Additionally, since the technique appears to be known in the art, applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Response to Arguments
Applicant’s arguments with respect to claim 13 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. Applicant has amended the claim to include the feature of determining the feed rate of the inspection scope based on an artificial intelligence algorithm. However, this newly recited feature is rendered obvious by Miller and Kanno as set forth in the rejection above.
Conclusion
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/NATASHA N CAMPBELL/Primary Examiner, Art Unit 1714